Toxic Substances Control Act Sections 5/8 Inspection Guidance


        United States        Office of Compliance Monitoring          Nov8fl#ef,4992
        Environmental Protection    Washington. DC 20460
        Agency
c/EPA  Toxic Substances
        §§ 5/8 Inspection Guidance

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                    ACKNOWLEDGMENTS

This manual,  intended to provide guidance  to  Regional  inspectors
responsible for conducting inspections under Sections 5 and 8 of the
Toxic  Substances Control Act  (TSCA), was prepared by  Science
Applications International Corporation (SAIC) in partial fulfillment of the
U.S. Environmental Protection Agency (EPA) Contract No. 68-C8-0066,
Work Assignment C-4-84. The development of the manual was managed
by Pamela Saunders;) the EPA Work Assignment Manager, Maureen
Lydon, Chief of ttie\£ompliance  Branch, and Philip Milton, Chemical
Engineer; of the Office of Compliance Monitoring  (OCM).

The  manual has been reviewed by EPA Headquarters and  several
Regional  Offices  and their  comments  have  been  incorporated as
appropriate.

George Clark and Carol Winston of SAIC were the Work Assignment
and Task Managers, respectively.  Principal authors at SAIC include:
Timothy Brown, Mark Ernstmann, Reng Eyerly, Jennifer Gale, Thomas
Lavelle, Jody Lehrer, and Travis Wagner.
                        DISCLAIMER

Neither the United States Government nor its employees makes any
warranty, express or implied, or assumes any legal liability for any third
party's use of or the results of such use of any information, product, or
process discussed in this document. Mention or illustration of company
or trade names,  or  of commercial  products,  does not  constitute
endorsement by the U.S. Environmental Protection Agency.  It should
also  be noted  that the tables  found throughout the manual provide
summaries of the  regulations as  a quick reference for the inspector.
However,  the  inspector should  note  that these  summaries are not
intended to substitute for the regulations published in the Code of Federal
Regulations and Federal Register, and thus the appropriate citations are
included in these tables for the inspector's use.

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                                                         Table of Contents
                          TABLE OF CONTENTS
CHAPTER 1  INTRODUCTION

      1.0   INTRODUCTION  	  1-1
      1.1   WHAT IS TSCA?	  1-1
      1.2   PURPOSE OF THIS INSPECTION MANUAL  	  1-8
      1.3   NATIONAL ENFORCEMENT PROGRAM PRIORITIES	  1-9


CHAPTER 2  TARGETING OF TSCA SECTION 5 AND 8 INSPECTIONS

      2.0   TARGETING OF TSCA SECTION 5 AND 8 INSPECTIONS	2-1
      2.1   INTRODUCTION AND PURPOSE  	2-1
      2.2   OVERVIEW OF TSCA INSPECTION TARGETING PROCESS  	2-2
      2.3.   DESCRIPTION OF TARGETING MECHANISMS	2-6
      2.4   INFORMATION SOURCES	  2-23
      2.5   SETTING PRIORITIES AND SELECTING SPECIFIC TARGETS	  2-30


CHAPTERS  PRE-INSPECnON ACTIVITIES: PREPARATION AND PLANNING

      3.0   PRE-INSPECnON ACTIVITIES: PREPARATION AND PLANNING	3-1
      3.1   INTRODUCTION  	  3-1
      3.2   REVIEWING EPA RECORDS	  3-5
      3.3   PROVIDING ADVANCE NOTIFICATION  	  3-17
      3.4   A WRITTEN INSPECTION PLAN	  3-25
      3.5   GATHERING INSPECTION DOCUMENTS AND EQUIPMENT  	  3-30


CHAPTER 4  INSPECTION MANAGEMENT

      4.0   INSPECTION MANAGEMENT	  4-1
      4.1   INTRODUCTION  	  4-1
      4.2   AUTHORITY	  4-1
      4.3   PRELIMINARY STEPS FOR CONDUCTING A TSCA INSPECTION	4-5
      4.4   CONSENT TO ENTER AND INSPECT  	4-6
      4.5   DENIAL OF CONSENTTO ENTER AND INSPECT	  4-11
      4.6   ADMINISTRATIVE WARRANTS	  4-12
      4.7   THE OPENING CONFERENCE  	  4-19
      4.8   INSPECTION PLAN REVISIONS 	  4-25
      4.9   THE CLOSING CONFERENCE  	  4-26
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November 1992

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Table of Contents
CHAPTER 5  TSCA SECTION 4 INSPECTIONS

     5.0   TSCA SECTION 4 INSPECTIONS	 5-1
     5.1   INTRODUCTION  	 5-1
     5.2   INSPECTION OBJECTIVES	 5-5


CHAPTER 6  TSCA SECTION 5 INSPECTIONS	 6-1

     6.1   INTRODUCTION	 6-1
     6.2   PREMANUFACTURE NOTICE REQUIREMENTS	6-8
     6.3   TSCA SECTION 5(e)/5(f) ORDER	 6-23
     6.4   SIGNIFICANT NEW USE RULE	 6-29
     6.5   LOW VOLUME EXEMPTION  	 6-36
     6.6   RESEARCH & DEVELOPMENT EXEMPTION	 6-41
     6.7   TEST MARKETING EXEMPTION  	 645
     6.8   POLYMER EXEMPTION  	 6-52
     6.9   INSTANTFILM CHEMICAL EXEMPTION (IFCE)	 6-57
     6.10   ZERO EXPOSURE	 6-64


CHAPTER 7  TSCA SECTION 8 INSPECTIONS

     7.0   TSCA SECTION 8 INSPECTIONS	 7-1
     7.1   INTRODUCTION  	 7-1
     7.2   SECTION 8(a)	 7-4
     7.3   SECTION 8(a): INVENTORY UPDATE RULE 	 7-21
     7.4   SECTION 8(c): ALLEGATIONS OF SIGNIFICANT ADVERSE HUMAN
           HEALTH OR ENVIRONMENTAL EFFECTS	 7-26
     7.5   SECTION 8(d): HEALTH AND SAFETY STUDIES	 7-32
     7.6   SECTION 8(e): NOTIFICATION OF SUBSTANTIAL RISKS 	7-35


CHAPTERS  TSCA SECTIONS 12 AND 13

     8.0   TSCA SECTIONS 12 AND 13	 8-1
     8.1   INTRODUCTION  	 8-1
     8.2   TSCA SECTION 12 EXPORT NOTIFICATION RULE	8-1
     8.3   TSCA SECTION 13 IMPORT RULE 	 8-3


CHAPTER 9  BIOTECHNOLOGY REGULATION

     9.0   BIOTECHNOLOGY REGULATION	9-1
     9.1   INTRODUCTION  	 9-1
     9.2   BACKGROUND  	 9-1
     9.3   CURRENT POLICY	 9-2
     9.4   OTHER ISSUES  	 9-4
     9.5   SUMMARY  	 9-5
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TSCA 55 5/8 Inspection Guidance

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                                                       Table of Contents
CHAPTER 10 POST-INSPECTION ACTIVmES

     10.0  POST-INSPECTION ACTIVmES	 10-1
     10.1  INTRODUCTION  	 10-1
     10.2  FOLLOWUP	 10-1
     10.3  THE INSPECTION REPORT 	 10-2
     10.4  WHAT TO DO WITH COMPLETED INSPECTION REPORT	 10-9
APPENDIX 1
APPENDIX 2

APPENDIX 3
APPENDIX 4
APPENDIX 5
APPENDIX 6
APPENDIX 7
APPENDIX 8
APPENDDC 9
APPENDIX 10
APPENDDC 11

APPENDIX 12

APPENDIX 13


APPENDDC 14


APPENDDC 15
             APPENDICES

OCM MEMORANDUM TO IMD REQUESTING TARGETING PRINTOUTS
GUIDANCE FOR REQUESTING TSCA SECTION S AND 8 ENFORCEMENT
REQUESTS
LIST OF INDUSTRIAL PROCESS REFERENCES
RECOMMENDED  PROCEDURES FOR ENFORCEMENT PERSONNEL
RESPONSIBLE FOR HANDLING SECTION S CONFIDENTIAL BUSINESS
INFORMATION
SAMPLING PROCEDURES
REGIONAL POLLUTION PREVENTION CONTACTS
CHEMICALS ON REPORTING RULES (CORR) DATABASE
PREMANUFACTURE NOTICE
GLOVE TESTING GUIDELINE
PAIR FORM
EPA POLICY: STATEMENTOF INTERPRETATION AND ENFORCEMENT
POLICY; NOTIFICATION OF SUBSTANTIAL RISK (43 FR 11110)
REPORTING GUIDANCE: TSCA SECTION 8(E) COMPLIANCE AUDIT
PROGRAM
FINAL RULE: CHEMICAL IMPORTS AND EXPORTS; GENERAL IMPORT
REQUIREMENTS  AND  RESTRICTIONS  POLICY FOR IMPORT  OF
CHEMICAL SUBSTANCES (48 FR 55462)
ANNOUNCEMENT OF POLICY AND NOTICE FOR PUBLIC COMMENT:
COORDINATED FRAMEWORK FOR REGULATION OF BIOTECHNOLOGY
(51 FR 23302)
INSPECTION CHECKLIST
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November 1992

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Chapter One	Introduction



Chapter One


Introduction


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1.0    INTRODUCTION	 1-1

1.1    WHAT IS TSCA?	 1-1

      1.1.1  SUMMARY: TSCA SECTION 4	 1-3
      1.1.2  SUMMARY: TSCA SECTION 5	 1-3
      1.1.3  SUMMARY: TSCA SECTION 8	 1-5
      1.1.4  SUMMARY: TSCA SECTION 12  	 1-6
      1.1.5  SUMMARY: TSCA SECTION 13	 1-7

1.2    PURPOSE OF THIS INSPECTION MANUAL 	 1-8

1.3    NATIONAL ENFORCEMENT PROGRAM PRIORITIES	 1-9

      1.3.1  HEADQUARTERS-REGIONAL MEMORANDUM OF AGREEMENT (MOA)
           PROCESS	 1-9
      1.3.2  FY 1993 NATIONAL PROGRAM PRIORITIES  	 1-9
      1.3.3  HQ-REGKDNAL MEMORANDUM OF AGREEMENT	  1-10
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Introduction	                                                    Chapter One
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Chapter One	Introduction

                                    1.0 INTRODUCTION

1.1    WHATISTSCA?
In 1976, Congress enacted die Toxic Substances Control Act (TSCA) to "...  regulate commerce and
protect human health and the environment by requiring testing and necessary use restriction on certain
chemical substances, and for other purposes." In the years following its enactment, TSCA was amended
to add two new titles governing asbestos and radon.  These titles,  mentioned only for informational
purposes, are not the subject of mis manual.1 Throughout the remainder of this manual, the use of the
term "TSCA" refers to Tide I only.

TSCA contains several congressional findings that form the basis for regulating toxic substances. Two
of these findings are mat humans and the environment are exposed yearly to many chemical substances
and mixtures and that the manufacturing, processing, distribution in commerce, use, and disposal of some
of these chemicals and mixtures may pose an unreasonable risk of injury to health or the environment.

TSCA is composed of 31 sections, requiring that specific actions pertaining to chemical substances or
mixtures be taken by either the affected community or by the U.S.  Environmental Protection Agency
(EPA) to protect human health and the environment.  TSCA, and the rules promulgated pursuant to
TSCA, regulate the manufacturing, processing, distribution in commerce, use, and disposal of chemical
substances  and  mixtures.   The term "chemical substance," as  defined by  TSCA,  lists numerous
exclusions, including pesticides, tobacco and tobacco products, nuclear materials and byproducts, food,
food additives, drugs, cosmetics, and devices.2

TSCA is different from other  environmental laws administered by EPA in two major ways: TSCA
regulates the manufacturing and use aspects of chemical substances, while other environmental laws
regulate the waste streams of chemical manufacturing and/or use operations;  and TSCA regulates
chemicals that  have  not  yet  been  manufactured  and introduced into commerce  whereas other
       TSCA was amended in 1986 and in 1988, each time by creating a new title: Title n (the Asbestos
       Hazard Emergency Response Act (AHERA) of 1986), which concerns asbestos-containing materials in
       public and private elementary and secondary schools, and Tide in (die Indoor Radon Abatement Act
       of 1988), which pertains to indoor radon gas pollution. These tides are not addressed in this inspection
       manual

       For specific definitions of each exemption from die term •chemical substance* under TSCA, see Section
       3 of TSCA (-definitions').
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Introduction Chapter One

environmental laws pertain to chemicals already in the stream of commerce. TSCA's regulation of
chemical substances prior to thei$ introduction into commerce (i.e., new chemicals) allows EPA to obtain
data necessary to assess the potential risks of such chemicals early on and to take any regulatory action
that may be necessary to protect human health and the environment before the substance reaches the
environment or the consumer. In addition, EPA regulates chemical substances and mixtures already being
manufactured and introduced into commerce (i.e., existing chemicals). TSCA's regulations for existing
chemicals allow EPA to obtain data necessary to assess the potential risksof these chemicals in commerce
and to regulate their manufacture, processing, distribution in commerce, use, and disposal if they pose
an unreasonable risk to human health or the environment. Therefore, for TSCA regulatory purposes,
chemicals are divided into two categories: new chemicals and existing chemicals. The different sections
of TSCA pertain to one or both of these categories. For example, Section 5 of TSCA governs new
chemicals by requiring the submission to EPA of a Premanufacture Notice (PMN) by manufacturers,
while Section 6 can be used to regulate existing chemicals.

Under TSCA Section 6, EPA is authorized to regulate chemical substances and mixtures only where the
Agency has made an initial finding that such substances or mixtures pose, or will pose, an unreasonable
risk of injury to human health or the environment. In addition, in making a regulatory determination
under the law, Section 2 of TSCA requires EPA to consider the "environmental, economic, and social
impact" of each regulatory action taken or proposed.

The major sections of TSCA that are the subject of this manual are Sections 4, S, 8, 12, and 13. These
sections pertain to the following topics: testing of chemical substances (Section 4); PMNs and PMN
exemptions (Section S); reporting and retention of information (Section 8); exports of chemical substances
(Section 12); and imports of chemical substances (Section 13). Section 4 inspections pertaining to Good
Laboratory Practices (GLPs) are not covered in this manual because they are conducted separately in
accordance with other EPA guidance. EPA is responsible for conducting compliance monitoring
inspections under these sections of TSCA to ensure that the regulated community (manufacturers,
importers, and processors) comply with TSCA. In the manual, Section 4 is addressed in Chapter S,
Section 5 in Chapter 6, Section 8 in Chapter 7, and Sections 12 and 13 in Chapter 8. In addition, the
manual discusses EPA's policy on biotechnology hi Chapter 9. The following paragraphs summarize the
sections of TSCA that are addressed in the manual. Detailed discussions of the requirements under each
section are found in the appropriate chapters.
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Chapter One	Introduction

1.1.1  SUMMARY: TSC A SECTION 4
Section 4(a) provides the authority for EPA to require by rule that testing be conducted by manufacturers,
importers,  or processors to determine the effects of a chemical substance or mixture when the
Administrator determines mat the manufacture, distribution, processing, use, or disposal of the chemical
substance or  mixture may present an unreasonable risk to  health or the environment.  When  EPA
promulgates a test rule under Section 4(a), the rule must include identification of the substance for which
testing is required, the standards for the development of the test data, and specification of the period of
time for which the data  must be submitted.

A company manufacturing,  importing, or processing a chemical  subject to a Section 4 test rule  must
submit a letter of intent  to conduct the testing or apply for and receive an exemption.  An exemption is
granted if the chemical substance or mixture is equivalent to another substance for which test data have
been submitted under another rule and submission of such data would be duplicative of test data that have
been submitted or will be developed. If the exemption is granted on the basis of previously submitted
data and is granted within the reimbursement period for such test data, then the company granted the
exemption must provide fair and equitable reimbursement to the person who previously submitted the test
data.

Companies conducting  testing under Section 4 test rules and consent orders must follow  the  GLP
Standards that are contained in 40 CFR Part 792 and the applicable test standard required by the rule or
consent order.

1.1.2  SUMMARY: TSC A SECTION 5
Section 5(a) of TSCA prohibits any person from manufacturing or importing a new chemical substance
[i.e., one mat does not  appear on the chemical  substance list (or  Inventory)] established under Section
8(b) without notifying EPA at least 90 days prior to that activity. Notification is done through the
submittal of a PMN.  This PMN requirement enables EPA to screen a new chemical before its
commercial production or importation begins.  The review period is intended to provide EPA witfc an
opportunity to review  and evaluate information  pertaining to  the substance to determine  whether
manufacture,  processing,  distribution in commerce, use, or disposal should  be limited or prohibited
because of insufficient data with which to determine health and environmental effects of the substance or
because the substance will present an unreasonable risk of injury  to health and the environment.  Aft*.
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Introduction	Chapter One

making the required findings, EPA may  take any of a number of actions to  regulate the chemical
substance as discussed below.

If EPA takes no action to limit use or delay the review period, the submitter may begin production, but
must submit a Notice of Commencement (NOQ within 30 days. The submitter may withdraw its PMN
at any time during the review process without giving a reason.

If the  Administrator determines that the information available is insufficient to permit a reasonable
evaluation of the health and environmental effects of a chemical substance with respect to which notice
is required and that the manufacture, processing, distribution in commerce, use,  and disposal of such a
substance may present an unreasonable risk to health or the environment, (oj the substance will be
produced in substantial amounts that may either enter the environment or cause substantial or significant
human exposure to the substance), then s/he may issue a proposed order [i.e., Section S(e) order], to take
effect on the expiration of the notification period,  prohibiting or limiting the manufacture, processing,
distribution in commerce, use, or disposal, of such a substance.

If the  Administrator determines  that there is a  reasonable basis to conclude  mat the manufacture,
processing, distribution in commerce, use, or disposal of a chemical substance presents or will present
an unreasonable risk of injury to  health or environment,  s/he may either issue a rule under Section 6,
limiting the amount of such substance that may be manufactured, processed, or distributed (or take other
actions under Section 6) or issue an order under Section  S(f).  Under a Section 5(f) order, the
Administrator may prohibit the manufacture, processing, or distribution of a chemical substance or may
seek an injunction to prohibit manufacture, processing, or distribution. A proposed rule issued under
Section 5(f) will take effect immediately upon publication in the Federal Register. A Section 5(f) order
becomes effective on the expiration of the notification period.

Under  Section 5(a)(2), the Administrator, by rule and after the consideration of specific factors, may
determine mat the use of a chemical  substance constitutes "a significant new use," and thus requires a
significant new use rule (SNUR).  Any person who intends to manufacture or process such a substance
for  a "significant new use" (i.e., a non-ongoing use) must submit to the Administrator, at least 90 days
before  beginning manufacture or processing, notification of the intent to do so.  This significant new use
notice  (SNUN)  is functionally equivalent to a PMN except that  its  scope is limited to the particular
significant new use.  Thus, a SNUR turns an "existing chemical" into a "new chemical" for purposes

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Chapter One Introduction

of TSCA Section 5 by requiring submission of a SNUN on the existing substance before it is
manufactured or processed for the significant new use. Also, a SNUR can apply to processors as well
as manufacturers and importers, unlike PMNs, which apply to manufactures and importers only.

TSCA Section 5(h) establishes exemptions from the PMN requirement. Some of the exemptions are
chemical substances intended for test marketing or research and development and chemicals specifically
exempted by a rule promulgated by EPA (such as the exemption for low-volume chemicals, polymers,
and instant photographic films). Some of these exemptions require prior application to EPA and EPA
approval. O&ers, such as the research and development exemption, are automatic if the company meets
the criteria specified in the pertinent regulations.

1.1 J SUMMARY: TSCA SECTION 8
TSCA Section 8 consists of five subsections that establish reporting and record keeping requirements.
Chemical manufacturers, importers, and processors and in certain cases distributors may be required
(unless exempt) to submit certain reports and/or maintain records.

Under Section 8(a), EPA has die authority to establish, by rule, record keeping and reporting
requirements for manufacturers, importers, and processors of chemical substances. The Preliminary
Assessment Information Rule (PAIR) requires manufacturers and importers to submit a two-page form
with information about any chemical listed by EPA in 40 CFR §712.30. EPA has also promulgated the
Comprehensive Assessment Information Rule (CAIR), which requires manufacturers, importers, and
processors to submit information in response to certain questions selected from a 140-page form on
chemicals identified by the EPA and listed in 40 CFR §704.225.

TSCA Section 8(b) requires EPA to maintain and update the TSCA Chemical Substances Inventory
Database, which lists each chemical substance that is manufactured or processed in the United States for
commercial purposes. The Inventory not only provides the basis for distinguishing between new and
existing chemicals under TSCA, but also provides information on the extent and volumes of
manufacturing and/or use of chemicals in commerce. Under TSCA Section 8(a), EPA promulgated the
Inventory Update Rule to keep the Inventory current by requiring manufacturers and importers to
periodically report on chemicals on the Inventory.
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Introduction	Chapter One

Under TSCA Section 8(c), companies are required to record "allegations of significant adverse reactions"
to any substance/mixture they manufacture, import, process, or distribute. EPA has issued an interpretive
rule under Section 8(c) (40 CFR Part 717) that requires manufacturers, importers, and certain processors
of chemical substances and mixtures to keep records concerning the allegations, and report to EPA those
records upon notice in the Federal Register or upon notice by letter.

Hie TSCA Section 8(c) rule provides a mechanism to identify previously unknown chemical hazards.
It may reveal (to EPA or an individual record keeper) patterns of adverse effects which otherwise may
not be noticed or detected.

TSCA Section 8(d) provides EPA  with the authority to promulgate rules to require manufacturers,
importers, or processors  (or prospective manufacturers, importers, or  processors) to submit  to the
Administrator of EPA lists and/or copies of ongoing and completed health and safety studies.  Under this
authority, EPA has promulgated a model health and safety data reporting rale (40 CFR Part 716), which
was developed to gather a broad range of data on specifically listed chemical substances and mixtures for
which EPA requires information in fulfilling the goals of TSCA (e.g., to support the testing program and
risk assessment).

Section  8(e) of TSCA requires that "...any  person who manufactures,  processes, or distributes in
commerce a chemical substance or mixture  and who obtains information which reasonably supports the
conclusion mat such substance or mixture presents a substantial risk of injury to human health or the
environment shall immediately inform the Administrator of such information unless such person has actual
knowledge that the Administrator has been adequately informed of such information."

1.1.4 SUMMARY: TSCA SECTION 12
Section  12(a)(l) of TSCA exempts  any chemical substance, mixture, or article containing a chemical
substance or mixture from the Act (except for the purposes of Section 8 of TSCA) if:
       •   The chemical substance, mixture, or article is being manufactured, processed, or distributed
           hi commerce for export only; and
       •   Such substance, mixture, or article, or any container in which it is enclosed, bears a stamp
           or label stating that the substance, mixture, or article is intended for export.
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Chapter One Introduction

Section 12(b) of TSCA requires any person who exports, or intends to export, a chemical substance or
mixture to notify EPA of such export to a foreign country if any of the following actions have been taken
under TSCA with respect to mat chemical substance or mixture:

• Data are required under Sections 4 or 5(b).
• An order has been issued under Section 5.
• A rule has been proposed or promulgated under Section S or 6.
• An action is pending, or relief has been granted under Section S or 7.

EPA issued a final export reporting rule on December 16, 1980 (45 FR 82844; 40 CFR Part 707).
Under this rule, an exporter must submit to EPA by letter, a notice of the first export, within the calendar
year, for the substance or mixture. Notice is required for the first export or intended export to each
foreign country in a calendar year. The notice must be postmarked within 7 days after acceptance of a
definite contractual obligation to export or an equivalent intracompany agreement to export. Where the
actual export occurs less man 7 days after the export obligation or agreement has been executed, the
notice must be submitted to EPA no later than the same day as the export.

After EPA has received the first annual notification from the exporter, EPA must then notify the
importing country's government of the exportation of the chemical, of any existing or proposed EPA
regulatory action against the chemical, and of the availability of test data on the chemical submitted to
EPA.

1.1.5 SUMMARY: TSCA SECTION 13
TSCA Section 13 requires the Secretary of the Treasury (U.S. Customs Service) to refuse entry into the
customs territory of the United States of any chemical substance or mixture if it fails to comply with any
rule in effect under TSCA, or if it is offered for entry hi violation of Sections 5 or 6, a Section S or 6
rule/order, or a Section 7 order. In addition, because TSCA defines importers as manufacturers,
importers may be subject to testing requirements under Section 4 and reporting requirements under
Section 8.

The U.S. Customs Service (Customs) published a rule concerning Section 13 on August 1, 1983, in 48
FR 34734 (19 CFR §12.118). The Customs rule sets forth general certification requirements and
detention procedures. However, it does not address how a chemical shipment and its import would

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Introduction Chapter One

comply with TSCA. EPA issued a policy statement December 13, 1983, in 48 FR 55462 (40 CFR Pact
707). It explains how EPA interprets and executes its responsibilities outlined in the Customs' Chemical
Substances Import Rule. The mam purpose of the EPA policy statement is to describe what compliance
with TSCA means.

Under the Customs rule, the importer of a chemical shipment must certify at the port of entry for
shipments entering commerce in the U.S. that either the shipment is subject to TSCA and complies with
all applicable rules and orders or the shipment is not subject to TSCA. An importer can accomplish the
certification and discharge his obligations related to the import by signing a brief typed or reprinted
statement on an entry document, invoice, or attachment.

Certification of compliance with TSCA is required for chemical substances imported in bulk or as part
of mixtures. Because some chemicals (e.g., tobacco and tobacco products) are not chemical substances
subject to TSCA, the Customs rule requires importers to certify mat such chemicals are not subject to
TSCA. The rule does not require certification for chemical substances imported as part of articles, unless
EPA requires reporting under a specific TSCA rule.

12 PURPOSE OF THIS INSPECTION MANUAL
Congress delegated responsibility for enforcing, and for promulgating rules pursuant to TSCA to the
EPA. EPA is responsible for ensuring compliance with and enforcement of TSCA. A comprehensive
compliance and enforcement program is necessary to ensure that EPA meets its congressional mandate
to protect human health and the environment.

An integral part of EPA's compliance program is the compliance monitoring inspection, conducted to
ascertain whether regulated facilities are complying with TSCA and the regulations promulgated pursuant
to it. This manual is intended to provide guidance to EPA inspectors who conduct compliance inspections
under TSCA Sections 4 (non-GLP), 5, 8, 12, and 13. While there are other EPA guidance materials
pertaining to TSCA inspections, and to environmental compliance inspections generally, this manual is
intended to only supplement them. Therefore, inspectors may and should refer to other documents as
necessary when performing inspections to determine compliance with TSCA Sections 4 (non-GLP), 5,
8, 12, and 13.
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Chapter One Introduction

1.3 NATIONAL ENFORCEMENT PROGRAM PRIORITIES
The purpose of this section is to provide to the inspector a discussion of the program priority-setting
process and the current program priorities. The Office of Compliance Monitoring, in consultation with
the Office of Pollution Prevention and Toxics and the Regions, sets enforcement and compliance priorities
to achieve National program objectives.

1 J.I HEADQUARTERS-REGIONAL MEMORANDUM OF AGREEMENT (MOA) PROCESS
Based on the FY 1992 National OPPTS meeting, the Assistant Administrator, Linda Fisher, decided that
OPPTS should proceed to develop a process whereby Headquarters and Regional Offices would prepare
and enter into joint Memoranda of Agreement. All Regions are expected to participate.

The intended purpose of the OPPTS HQ-Regional MOAs is to implement the pesticide and toxic
programs so as to achieve national program objectives in a way that recognizes the relevant circumstances
or conditions in the different regions. What this means is that both Regional and Headquarters
management will-reach agreement on program goals, flexibility,- and discretion. The goal of the MOA
process is to fully utilize available resources to address regional and national priorities for prevention,
pesticides, and toxics. The process is being implemented in the spirit of improving HQ-Regional
teamwork and partnerships for OPPTS programs. HQ and Regions recognize that the growing demand
on resources to meet an ever increasing array of priorities requires mat agreements be reached on
Regional and National priorities.

132 FY 1993 NATIONAL PROGRAM PRIORITIES
The FY 1993 National priorities for the TSCA Section 5 and 8 Inspection Program are for areas with
potential for high risk. This area has been identified as new chemicals inspection. New chemical
resources are to be used for priority inspections targeting: non-submitters of PMNs (including
importers); parties to risk-based Section 5(e) Consent Orders; companies subject to SNURs; and holders
of low-volume exemptions. After priority inspections have been addressed, remaining compliance and
enforcement resources may be used for the purposes of grant oversight and evaluation, conducting
multimedia or other special enforcement initiatives, or to meet compliance/enforcement needs in other
toxics areas. Any inspections Regions wish to conduct over and above the number established between
Headquarters and the Regional Office in the MOA process, for the new chemicals inspection category
may be used in assessing compliance with new chemical R&D and test marketing exemptions.
TSCA \\ 5/8 Inspection Guidance 1-9 November 1992

-------
Introduction	Chapter One

1JJ  HQ-REGIONAL MEMORANDUM OF AGREEMENT
Each Region should insert its current operating HQ-Regional Memorandum of Agreement for the TSCA
Section 5 and 8 program here.
November 1992                          1-10          TSCA 55 5/8 Inspection Guidance

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Chapter Two	Targeting TSCA Sections 5 and 8 Inspections



Chapter Two


Targeting TSCA Section 5 and 8 Inspections



                                                                  Page

2.0 TARGETING OF TSCA SECTION 5 AND 8 INSPECTIONS	2-1

2.1 INTRODUCTION AND PURPOSE  	 2-!

2.2 OVERVIEW OF TSCA INSPECTION TARGETING PROCESS  	2-2

   2.2.1 OVERVIEW	 2-2
   2.2.2 PAST EXPERIENCE	 2-4

2.3. DESCRIPTION OF TARGETING MECHANISMS	2-6

   2.3.1 NON-SUBMITTERS	..._	,	 2-9

        2.3.1.1 BACKGROUND  	 2-9
        2.3.1.2 EXPERIENCE	 2-9
        2.3.1.3 POTENTIAL SERIOUSNESS OF VIOLATION	 2-10
        2.3.1.4- STRATEGY 	 2-10

   2.3.2 TSCA SECTION 5(e)/(f) ORDERS  	 2-11

        2.3.2.1 BACKGROUND  	 2-11
        2.3.2.2 EXPERIENCE	 2-12
        2.3.2.3 TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS	2-12

   2.3.3 SIGNIFICANT NEW USE RULES	 2-13

        2.3.3.1 BACKGROUND  	 2-13
        2.3.3.2 EXPERIENCE	 2-13
        2.3.3.3 TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS	2-14

   2.3.4 PMN EXEMPTION APPLICATIONS	 2-15

        2.3.4.1 BACKGROUND  	 2-15
        2.3.4.2 EXPERIENCE	 2-15
        2.3.4.3 TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS	 2-16
TSCA SS 5/8 Inspection Guidance          2-i                       November 1992

-------
Targeting TSCA Sections 5 aid 8 Inspections	Chapter Two

    2.3.5  PREMANUFACTURE NOTIFICATION (PMN)	 2-16

         2.3.5.1  BACKGROUND  	 2-16
         2.3.5.2  EXPERIENCE	 2-17
         2.3.5.3  TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS	 2-17

    2.3.6  TSCA SECTION 8	 2-18

         2.3.6.1  BACKGROUND  	 2-18
         2.3.6.2  EXPERIENCE	 2-19
         2.3.6.3  TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS	 2-19

    2.3.7  OTHER POTENTIAL TARGETING MECHANISMS	 2-20

         2.3.7.1  TIPS AND COMPLAINTS	 2-21
         2.3.7.2  MULTI-MEDIA TARGETS  	 2-22
         2.3.7.3  HIGH-RISK CHEMICALS	 2-23
         2.3.7.4  GEOGRAPHIC-BASED TARGETING	 2-23

2.4  INFORMATION SOURCES	 2-23

    2.4.1  TSCA SECTION 5(e)/(f)	 2-24
    2.4.2  SNURs	 2-24
    2.4.3  PMN EXEMPTIONS 	 2-26
    2.4.4" PMNs WITHDRAWN	 2-26
    2.4.5  TSCA SECTION 8 TARGETING 	 2-27
    2.4.6  MULTI-MEDIA  	 2-28
    2.4.7  NON-SUBMITTERS  	 2-29

2.5  SETTING PRIORITIES AND SELECTING SPECIFIC TARGETS	 2-30

    2.5.1  DEVELOPING A MASTER LIST	 2-30
    2.5.2  SETTING PRIORITIES AMONG TARGETING AREAS	 2-30
    2.5.3  SELECTING SPECIFIC FACILITIES WITHIN TARGETING AREAS	 2-32
November 1992                         2-ii          TSCA 55 5/8 Inspection Guidance

-------
Chapter Two	Targeting TSCA Sections 5 and 8 Inspections

                            LIST OF FIGURES
FIGURE 2-1      FLOW CHART OF TARGETING AND INSPECTION  	2-3
FIGURE 2-2      SETTING PRIORITIES (WEIGHTS) AMONG PROGRAM AREAS . . . 2-33
FIGURE 2-3      TARGETING WORKSHEET 1	 2-34
FIGURE 2-4      SELECTING FACILITIES WITHIN PROGRAM AREAS	 2-36
FIGURE 2-5      TARGETING WORKSHEET 2	 2-37
                            LIST OF TABLES
TABLE 2-1A      SUMMARY OF INSPECTIONS BY TYPE AND YEAR	2-5
TABLE 2-1B      SUMMARY OF ACTIONS BY TYPE AND YEAR	2-5
TABLE 2-2A      SUMMARY OF INSPECTIONS BY TYPE AND REGION	2-7
TABLE 2-2B      SUMMARY OF ACTIONS BY TYPE AND REGION	2-7
TABLE 2-3       SUMMARY OF STATISTICS ON SUBMISSIONS AND EPA ACTIONS . 2-8
TABLE 2-4       INFORMATION AVAILABLE IN TARGETING PRINTOUTS
               FROM IMD THROUGH OCM	 2-25
TSCA 88 5/8 Inspection Guidance         2-iii                       November 1992

-------
Targeting TSCA Sections 5 and 8 Inspections     	        	   Chapter Two
                                  BLANK PAGE
November 1992                          2-iv           TSCA 5§ 5/8 Inspection Guidance

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Chapter Two Targeting TSCA Sections 5 and 8 Inspections
2.0 TARGETING OF TSCA SECTION 5 AND 8 INSPECTIONS

2.1 INTRODUCTION AND PURPOSE
The purpose of the Toxic Substances Control Act (TSCA) Sections 5 and 8 inspection program is not only
to monitor compliance and identify violators, but also to establish an enforcement presence and to provide
a deterrent effect for potential violations. To this end, it is important to focus limited resources on
significant, enforceable, and nationally important cases that can serve as examples. At the same time,
however, it is important to maintain a neutral approach to identifying potential facilities to be inspected,
based on clearly stated, previously established priorities.

This chapter has several purposes. First, it provides an explanation and background on mechanisms
currently being applied in Regional inspection programs for identifying potential violators. Second, it
can serve as a reference to educate new inspectors in targeting issues and activities. Third, it introduces
schemes for ranking and prioritizing identified inspection targets to meet specific Regional concerns and
resource constraints.

The remainder of this chapter is organized into four sections. Section 2.2 provides an overview of the
inspection targeting process and some historical information on the TSCA Sections 5 and 8 inspection
program. Section 2.3 provides a detailed description of various targeting mechanisms that have been used
or proposed by National Enforcement Investigations Center (NEIC) and Regional inspectors and past
guidance from Headquarters, including a discussion of the relevant statutory language. Section 2.4
discusses the types of data and databases that are available to help Regional inspectors find the
information they need to identify potential violators. Section 2.5 discusses specific implementation
approaches and how to select specific facilities based on established priorities and ranking schemes.
TSCA 55 5/8 Inspection Guidance 2-1 November 1992

-------
Targeting TSCA Sections 5 and 8 Inspections Chapter Two
22 OVERVIEW OF TSCA INSPECTION TARGETING PROCESS

22.1 OVERVIEW
Targeting identifies facilities for inspection based on their potential for violation of TSCA requirements.
Various mechanisms or criteria can be used to identify potential violators. In addition, priorities among
different targeting mechanisms can be set in several ways, with the intent that limited resources be
allocated in a way that maximizes the potential to mitigate hazards to health or the environment.

Because there are so many options for targeting, national guidance on inspection strategies and priorities
is needed to ensure consistency, while allowing for necessary flexibility among Regions and program
areas. In addition, uniform guidance is important to satisfy the requirements of a Neutral Administrative
Inspection Scheme (NAIS). The objective of an NAIS is to identify and select inspection targets for the
purpose of increasing compliance by facilities subject to the law and to meet the standard established in
Marshall v. Barlow's, Inc. (436 U.S. 307, 1978) that a NAIS be used for facility selection. An NAIS
provides a rationale for selection of specific facilities, so that a court reviewing an inspection scheme will
see how decisions were made and how the final scheme was justified.

In response to the need to achieve better communication and exchange between the Regions and
Headquarters, OCM held a conference on the TSCA Section 5 and 8 program in June of 1991. Among
other things, participants at the conference identified targeting and inspection strategies as an important
area for discussion. Regions specifically asked for more detailed targeting guidance and practical
priorities. This targeting guide is a response to the issues and ideas raised at the conference.

Figure 2-1 is a flow chart of the targeting and inspection process. This flow chart helps to provide a
conceptual perspective for this entire guidance manual. This chapter deals with identifying potential
violators and setting priorities to select individual inspection targets. Chapter 3 deals with pre-inspection
preparation activities, while Chapter 4 deals with inspection management (i.e., conducting inspections).
Activities associated with specific types of inspections (e.g., Section 5 inspections, PAIR inspections) are
discussed in Chapters 5 through 8. Finally, Chapter 10 discusses post-inspection activities, such as
writing the inspection report.

The flow chart presented in Figure 2-1 not only serves to link the activities discussed in each chapter,
but also helps to identify important functions that are not discussed in detail in this document.
November 1992 2-2 TSCA 55 5/8 Inspection Guidance

-------
 Chapter Two
     Targeting TSCA Sections 5 and 8 Inspections
                                       FIGURE 2-1

                     FLOW CHART OF TARGETING AND INSPECTION
SET PRIORITIES/WEIGHTS
• HQ Guidance
• Regional/Environmental Concerns
IDENTIFY POTENTIAL TARGETS
• Review Printouts
• Factor in Regional Information
• Tips and Complaints
                 OUTREACH ACTIVITIES
                 • Workshops
                 • Educational Mailings
                 • States/Interagency Notices
SELECT FACILITIES TO BE
INSPECTED
• STARS Commitments
• Personnel/Scheduling
• Secondary Inspections
             I
                    RESOURCE ASSESSMENT
                    •  Constraints
                    •  Opportunities
   PRE-BMSPECnON ACTIVITIES
CONDUCT INSPECTIONS
• Primary
• Secondary
^

POST INSPECTION
• Enforcement
• Cross-Media Referrals
• Potential Targets
                                                              ANNUAL EVALUATION
                                                              • Performance Appraisal
                                                              • Program Planning
 TSCA g§ 5/8 Inspection Guidance
2-3
November 1992

-------
Targeting TSCA Sections 5 and 8 Inspections Chapter Two
Performance evaluation, assessment of resource levels, and outreach activities are important to the success
of the overall TSCA inspection program, even though they are not discussed in detail in this manual.
For example, each Region must evaluate resources available for inspections and then develop specific
inspection priorities, targets, and commitments for the year.1 The flow chart helps to show that this
annual resource assessment and prioritization are parts of a continuing process that can build on lessons
learned from the past year of activity. Similarly, outreach activities can be viewed as part of the
inspection program and as one of the links between individual inspections and the next year's targeting
process. Outreach activities may result in improved compliance or revision of priorities and resource
allocations.

2.2.2 PAST EXPERIENCE
As a basis for understanding targeting strategies, it is useful to have some historical information on the
results and effectiveness of past efforts. Traditionally, facilities have been identified and inspections have
been conducted based on the types of violations under the various sections of TSCA. The Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and TSCA Tracking System (FTPS) records data
on the types of inspections conducted, types of violations found, and actions taken. This information is
extracted by the Office of Compliance Monitoring (OCM) into the National Compliance Database
(NCDB), which was available for analysis. Such background information can also provide a context for
evaluating proposed changes in priorities.

Table 2-1A summarizes information on past inspections and their distribution across different types of
inspections for the years 1986 to 1991. Table 2-1B summarizes actions that resulted from these
inspections for the same period. The categories of inspections listed appear in the database and
correspond roughly to the types of inspections conducted by Regions. It is important to note that the
categories of inspections are not mutually exclusive. That is, a given facility that is the site of a Section
5 and a Section 8 inspection will be counted as two inspections. In addition, some of the categories do
not provide a fine level of resolution. For example, the category titled simply "inspection" may represent
a comprehensive inspection of all areas, but the individual areas may also be recorded. Furthermore,
actions in a given year do not necessarily result from inspections in the same year. For these reasons,
these data must be interpreted with caution. Further information on each of the categories can be
obtained from the FIFRA/TSCA Tracking System (FITS) FITS Database Information (September 1991).
1 These decisions must be documented to satisfy the requirements of a NAIS to show how Regional
priorities were derived from a neutral scheme and resource constraints.

November 1992 2-4 TSCA 8S 5/8 Inspection Guidance

-------
Chapter Two
                            Targeting TSCA Sections 5 and 8 Inspections
           TABLE 2-1A SUMMARY OF INSPECTIONS BY TYPE AND YEAR
bspeeteType
Chcnuci] Subatance Exemption
Inapectien
Sec. 5(e)/(f) Order
Failure to Notify
Pretnamibctun Notice
SNUR
Ten Marketing Exemptioo
Section 5 Total
Comprehensive Inspection
See. 8(e) Reeordi Rule
8(d) Health/Safety Studies
8(t) Level • Rule
Inventory Update Rule
See. 8(e) SubcuittUl Risk
Section 8 Total
Total Inspection
Yew
If
0
72
1
1
23
0
0
91
7
51
0
37
57
3
155
252
1986
1
29
0
3
28
0
0
61
0
29
6
14
16
4
69
130
1987
1
17
4
4
38
0
5
69
1
35
12
26
20
9
103
172
1988
22
101
13
6
76
0
2
220
8
85
22
23
113
15
266
486
1989
24
83
6
20
79
0
1
213
13
59
13
32
65
15
197
410
1990
5
91
4
3
27
0
2
132
57
31
7
18
20
12
145
277
1991
8
118
9
3
- 53
1
3
195
98
23
13
23
51
3
211
406
1992
0
2
0
0
1
0
0
3
1
1
0
0
0
0
2
5
Total
61
513
37
40
325
1
13
990
185
314
73
173
342
61
1.148
2,138
%OTAD
Inspections
2.9
24.0
1.7
1.9
15.2
0.0
0.6
46.3
8.7
14.7
3.4
8.1
16.0
2.9
53.7

  1 The numben in ihii cohii
       t uupceiions that were not identified by date.
              TABLE 2-1B SUMMARY OF ACTIONS BY TYPE AND YEAR
Type
flui * 1 Ci kM K t*

Inapcetion
Section 5(e)/(0 Order
Failure to Notify
Premamifaeture Notice
SNUR
Ten Marketing Exemption
Sections Total
CojHpfBucfliivft InipdctlOB
See. 8(c) Reeordi Rule
See. 8(d) Health/Safety Rule
Sec. 8(1) Level a Rule
Inventory Update Rule
Sec. 8(e) Subnmial Riik
Section 8 Total
Total Action
YMT
IP
2
5
0
0
20
0
0
27
1
0
0
5
14
0
20
47
1986
0
0
0
0
1
0
0
1
0
0
0
1
0
0
1
2
1987
0
0
0
0
1
0
0
1
0
0
0
1
0
0
1
2
1988
0
2
1
0
7
0
0
10
0
0
0
1
5
0
6
16
1989
0
2
0
0
8
0
0
10
0
1
0
2
3
0
6
16
1990
0
12
1
3
18
0
0
34
4
1
0
3
II
2
21
55
1991
0
14
1
3
16
0
0
34
3
1
0
6
5
0
15
49
1992
1
4
1
2
11
0
0
19
6
0
0
3
5
0
14
33
Total
3
39
4
8
82
0
0
136
14
3
0
22
43
2
84
220
«ofAH
Action*
1.4
17.7
1.8
3.6
37.3
0.0
0.0
61.8
6.4
14
00
100
195
0.9
38.2

  'The total* in thii<
i repieacnt intpections that were not identified by date.
TSCA 55 5/8 Inspection Guidance
                       2-5
November 1992

-------
Targeting TSCA Sections 5 and 8 Inspections Chapter Two
However, comparisons between the two tables provide some interesting observations. For example,
premanufacture notice (PMN) inspections accounted for about a third of the total Section 5 inspections,
but over half of the actions taken as a result of Section 5 violations. Although this comparison clearly
shows that PMNs are a plentiful source of violations, this disparity could result for several reasons:
PMN violations are commonly found as a result of other types of inspections, PMN violations are easier
to document than other types of inspections, or inspectors routinely spend more time searching for PMN
violations than other types. Inventory Update Rule (IUR) inspections show a similar pattern: the
proportion of IUR violations compared to Section 8 violations exceeds the proportion of IUR compared
to total Section 8 inspections conducted.

Some categories of inspection activity show the opposite trend. For example, Section 8(c) inspections
represent 27 percent of the total Section 8 inspections but only about 3.6 percent of Section 8 enforcement
actions. This could mean that firms are generally in compliance or that violations are difficult to
document. Depending on the actual reasons, OCM or a particular Region could evaluate priorities for
the distribution of future inspections based on a review of these types of data. In addition, a more
detailed analysis of this type of historical information on inspected firms (or submitters), by industrial
category or location, could be useful in designing approaches to improve coverage of unknown, non-
submitting facilities (see Section 2.3.1 of this chapter).

Tables 2-2A and 2-2B present the same information on inspections and actions broken down by Region,
• rather than by year. These tables show the relative differences among Regions in types of inspections
conducted, which may reflect differences in resource levels and priority placed on various types of
inspections. Also, the table reflects the fact that some Regions have been .conducting inspections longer
than others.

To provide background on the size of the program, Table 2-3 shows overall statistics on the numbers of
various types of submissions from industry and actions by EPA under TSCA Section 5. The table
provides some perspective on the volume of new chemical submissions, EPA actions, and the size of the
inspection workload.

2J. DESCRIPTION OF TARGETING MECHANISMS
The following section describes the various types of mechanisms that can be used to target TSCA Section
S and 8 inspections. The numbers in parentheses indicate the subsections of this chapter in which they

November 1992 2-6 TSCA $fi 5/8 Inspection Guidance

-------
Chapter Two
     Targeting TSCA Sections 5 and 8 Inspections
         TABLE 2-2A SUMMARY OF INSPECTIONS BY TYPE AND REGION
Inspection Type
Chemical Substance Exemption
Inspection
Sec. 5(e)/(0 Older
Failure to Notify
Picimnu&cture Notice
SNUR
Test Marketing Exemption
Section 5 Totcl
viTiiiprrnftniivff Inspection
Sec. 8(c) Recordi Rule
8(d) Health/Safety Studies
8(a) Level a Rule
Inventory Update Rule
Sec. 8(e) SubitamUl Rifk
Section 8 Total
Total Inspections
Regioo
I
0
20
1
0
0
0
0
21
18
0
0
0
1
0
19
40
n
29
110
18
13
ISO
1
7
328
16
38
23
63
127
9
276
604
III
17
106
9
11
94
0
4
241
6
162
13
82
143
7
413
654
IV
0
18
0
0
4
0
0
22
18
1
0
0
0
3
22
44
V
15
156
8
0
54
0
2
235
45
108
37
19
65
38
312
547
VI
0
17
0
0
0
0
0
17
17
0
0
0
0
0
17
34
vn
0
22
0
0
1
0
0
23
16
1
0
2
2
1
22
45
VIII
0
17
0
0
0
0
0
17
12
4
0
0
0
1
17
34
EX
0
32
0
0
0
0
0
32
32
0
0
0
0
0
32
64
X
0
5
0
0
0
0
0
5
5
0
0
0
0
0
5
10
HQ/
NEIC
0
10
1
16
22
0
0
49
0
0
0
7
4
2
13
62
Total
61
513
37
40
325
1
13
990
185
314
73
173
342
61
1448
2,138
%OfAB
Inspection
2.9
24.0
1.7
1.9
15.2
0.0
0.6
46J
8.7
14.7
3.4
8.1
16.0
2.9
53.7

           TABLE 2-2B SUMMARY OF ACTIONS BY TYPE AND REGION
Type
Chemical Substance Exemption
Iiupection
Sec. 5(e)/(0 Order
Failure to Notify
Pretnuuifacture Notice
SNUR
Ten Marketing Exemption
Section 5 Total
VOfllprBnfllaJfW UMpOCUOD
Sec. 8(c) Recordi Rule
8(d) Health/Safety Studies
8(a) Level a Rule
Inventory Update Rule
Sec. 8(e) Substantial Risk
Section 8 Total
Total Actions
Rei
I
0
2
0
0
0
0
0
2
1
0
0
0
0
0
1
3
n
i
3
1
4
30
0
0
39
4
0
0
9
17
0
30
69
III
2
4
2
0
26
0
0
34
1
0
0
6
15
0
22
56
IV
0
4
0
0
3
0
0
7
1
0
0
0
0
0
1
8
V
0
13
0
0
11
0
0
24
3
1
0
4
9
0
17
41
VI
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
wo
vn
0
3
0
0
0
0
0
3
2
0
0
0
0
0
2
5
vra
0
2
0
0
0
0
0
2
2
2
0
0
0
0
4
6
DC
0
2
0
0
1
0
0
3
0
0
0
0
0
0
0
3
X
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
HQ/
NEIC
0
6
1
4
11
0
0
22
0
0
0
3
2
2
7
29
Total
3
39
4
8
82
0
0
136
14
3
0
22
43
2
M
220
%OfAB
Actions
1.4
17.7
1.8
3.6
37.3
0.0
0.0
61.8
6.4
1.4
0.0
10.0
19.5
0.9
38J

TSCA 88 5/8 Inspection Guidance
2-7
November 1992

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Targeting TSCA Sections 5 and 8 Inspections
                                          Chapter Two
     TABLE 2-3 SUMMARY OF STATISTICS ON SUBMISSIONS AND EPA ACTIONS
TYPE OF SUBMISSION
Prcmamifacture Notification
Tea Market Exemption Application
Polymer Exemption Application*
Low Volume Exemptions
Total New Chemical SuhmMOM
Notice! of Commencement
EPA Action*
Section 5(e) Orders baud
Section 5(0 Action* luued
PMN* Wuhdnwn in Face of Action
YEAR
1979-
1984
4.201
310
0
0
4,511
2,585

68
4
95
1985
1,462
61
154
94
1,771
780

47
0
78
1986
1,691
57
238
237
2423
793

67
0
92
1987
1,775
30
248
276
J4J9
825

61
0
100
1988
2,421
18
318
237
2.994
929

34
0
133
1989
1,037
28
174
265
1,504
540

54
0
122
1990
1.934
18
239
553
2,744
856

86
0
73
1991
1,385
25
178
279
1.867
259
TOTAL
15,906
547
1.549
1.941
19,943
7.567

87
0
86
Upftont (Vohintary) Testing Action*
Average Preaotice Conwhationt Per Year
504
4
779
351
1.200
  Source: Data an taken from the OTS New du
i Program Annual Report.
are discussed.
   •  Non-submitters (2.3.1)
   •  TSCA Section S(e)/5(f) orders (2.3.2)
   •  Significant new use rules (2.3.3)
   •  PMN exemption applications (2.3.4)
   •  Premanufacture Notification (PMN) (2.3.5)
   •  TSCA Section 8 (2.3.6).
Four additional targeting mechanisms include the following:
   •  Tips and complaints
   •  Multi-media targets
   •  High-risk chemicals
   •  Geographic targets.
These four potential targeting mechanisms are not widely or systematically used, so they are discussed
only in general terms (in Section 2.3.7) to give inspectors some practical ideas for applying these new
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approaches. This guide discusses each of the targeting mechanisms listed. As other mechanisms or
priorities are identified, they can be documented and inserted to ensure that the guide is a comprehensive
reference.

23.1 NON-SUBMITTERS
23.1.1 BACKGROUND
In accordance with Section 5(a) of TSCA, no person may manufacture or process a new chemical
substance for a non-exempt commercial purpose without notifying EPA at least 90 days prior to that
activity. Notification is accomplished through the submitta! of a PMN. The purpose of this requirement
is to provide EPA with the opportunity to determine whether the uncontrolled manufacture, importation,
processing, use, distribution in commerce, or disposal will present an unreasonable risk of injury to health
and the environment. A non-submitter is a person who fails to submit a premanufacture notification to
EPA prior to manufacturing or importing a new chemical substance.

One of the most serious violators of TSCA is the non-submitter, that is, a person failing to submit a PMN
for a chemical substance when one is required. Two apparent reasons for non-notification are ignorance
of the requirements and misidentification of the chemical substance.

• Ignorance of the requirements. A number of violations occur as a result of ignorance of the
requirements. The older the TSCA program gets, the less likely that such violations will occur.
However, importing new chemical substances remains a serious issue. That is, American
manufacturers or processors who may not normally deal with TSCA may import a new chemical
substance without the knowledge of the PMN program. Or a foreign entity may wish to begin
exporting to the United States and find a distributor or other handler. Both parties may be unaware
of PMN requirements under TSCA.
• Misidentification of the chemical substance. To determine whether a chemical substance is new and
therefore requires a PMN, it must be determined whether the chemical is listed in the TSCA
chemical substance inventory. The chemical substances are listed by the Chemical Abstract Services
(CAS) chemical name or a generic chemical name. It is possible that a potential manufacturer or
importer incorrectly identifies the name of a chemical substance, which could result in an incorrect
determination that the chemical is contained in the inventory.
2J.1.2 EXPERIENCE
Enforcement statistics characterizing the potential non-submitter community are very limited. This is
partly due to the limited number of inspections, reliance on self-confessions, limited tracking effort, and
the absence of many non-submitters from the TSCA tracking system (and, thus, these non-submitters may

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not be inspected for other purposes). Although the potential risk to health and the environment from non-

submitters is high, it is difficult and resource-intensive to target non-submitters given the nature of the

violation. It is important to note that non-submitters under Section 5(a) may also violate other TSCA
requirements, including Section 13 import certification. Although it is unclear how they were identified,

Table 2-2 shows that 40 inspections were conducted for "failure to notify," resulting in eight enforcement

actions taken by EPA. In addition, EPA's Enforcement Accomplishments Report for FY 1990 highlights
some enforcement cases involving non-submitters:

• Region n issued an administrative complaint to DSM Resins, Inc. (a subsidiary of a large Dutch-
based chemical conglomerate), citing a failure to file a PMN and failure to certify under Section 13.
The Region is proposing a penalty of $2.3 million. The company self-confessed the violations.

• The EPA filed an administrative complaint and gravity-based penalty of $1,909,000 against the P.O.
George Company for failing to file PMNs for nine subject chemical substances and Notices of
Commencement (NOCs). The company subsequently filed the PMNs and NOCs. The Chief
Judicial Officer ratified a consent agreement for a $527,850 fine; recovery and incineration of
buried drums of paint waste; and a Sections 5 and 8 audit to identify and report additional
violations.

• The EPA filed a civil complaint and proposed a $285,000 fine against Union Camp Corporation for
failing to submit a PMN. A consent agreement was reached where a $106,000 penalty was assessed
in addition to the submission of a revised company policy and procedures for PMN compliance and
a 5-year program of annual, day-long new chemical compliance meetings for responsible employees.
2 J.I J POTENTIAL SERIOUSNESS OF VIOLATION

Failing to submit a PMN is a serious violation, because the particular chemical has the potential to cause

an unreasonable risk to health and the environment and because EPA and the public are unaware of the
risk. The actual threat is difficult to assess because EPA has not had the opportunity to assess the

potential risk that the chemical substance may present. That is the purpose of the PMN process - to

provide EPA with the opportunity to review the potential risk to health and the environment of the

chemical substance.

2J.1.4 STRATEGY

Identifying non-submitters presents a unique challenge to EPA because non-submitters have never made

previous submissions under TSCA. To encourage compliance by both submitters and non-submitters,

outreach should be used to inform the regulated community of their obligations under TSCA. One tool
used in Region I to meet mis goal is outreach through direct mailings, press releases, and workshops.
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• Direct mail. Based on the information sources discussed in Section 2.4 of this chapter, a Regional
list of chemical manufacturers, importers, processors, and suppliers could be developed. The
mailing may include press releases on previous non-submitters as well as an announcement for the
EPA's self-confessor program. Such a mailing also may generate tips and complaints from
competitors or workers.
• Press releases. Some Regions have a policy to issue press releases related to administrative and
civil penalties. For any non-submitter penalized, the Region should aggressively distribute press
releases with special focus on the monetary penalty. Press releases could be sent to all appropriate
news media including television. However, non-submitter press releases also could be sent to
appropriate trade associations, foreign consulates, customs brokers, etc.
• Workshops. Periodically, the Regions conduct workshops or conferences focusing on TSCA
compliance or education. During these gatherings, an effort should be made to either inform
participants of the ramifications of non-submittal or to provide literature (such as a press release)
with a similar message.
The critical factor in effectively targeting non-submitters is possessing information that characterizes the
population. However, only limited information currently exists at EPA to assist in targeting non-
submitters. Historical information on non-submitters (previous violations), such as the ratio of importers
to domestic manufacturers, typical sizes of the companies, the types of chemicals, regions, countries of
origin, points of entry into the U.S., and primary SIC Codes, could be used to increase the effectiveness
of the targeting effort by characterizing the non-submitter population. An effort to develop and maintain
such statistics could improve Regions' abilities to target non-submitters.

232 TSCA SECTION 5(e)/(f) ORDERS
232.1 BACKGROUND
Any company intending to manufacture or import a new chemical substance must give EPA 90 days prior
notice under TSCA Section 5. This PMN requirement enables EPA to screen a new chemical before its
commercial production or importation begins. TSCA Section S(e) allows EPA to issue an administrative
order regulating or limiting die manufacture of a new chemical substance if the Agency finds (1) that
there is insufficient information to evaluate the risk of a chemical substance and (2) that the chemical may
present an unreasonable risk to health or the environment, oj that substantial amounts will enter the
environment or there will be substantial human exposure. A Section 5(e) order can restrict or ban the
manufacture, distribution, use, or disposal of a chemical pending development of data sufficient to allow
EPA to reasonably evaluate any risks posed by the chemical in question.
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Prior to issuing a Section 5(e) order, EPA will often negotiate a "consent order" with the PMN submitter.
Typically, in a Section 5(e) consent order, the manufacturer will be permitted to proceed with commercial
manufacture in return for adhering to any  restrictions on production, distribution, use, or disposal that
EPA deems necessary.  Thus, in the face of a Section S(e) order, a PMN submitter has three choices:
negotiate a consent order, fight a unilateral order, or withdraw the PMN (which the submitter may do
without explanation).

Section S(f) orders are similar but less common because they may prohibit manufacture totally, limit the
amount, or specify  the conditions of manufacture.  Also,  the risk standard of Section  5(f) is more
exacting than that of Section S(e).

2322 EXPERIENCE
As noted in the previous section, Section 5(e) orders are much more common than Section 5(f) orders.
As shown in Table 2-3, from FY 1986 through FY 1991,504 Section 5(e) orders and only 4 Section S(f)
orders have been issued.  Table 2-2A indicates that in all Regions, 37 inspections have taken place under
Sections 5(e) and (f) (1.7 percent of total inspections).

23 JJ TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS
Generally, Section S(e)/5(f) orders are issued in response to a Section 5(a) PMN when EPA has serious
concerns about a chemical.   Accordingly, potential  Section 5(e)/S(f) violations warrant  high priority.
Companies subject to a Section 5(e) order should be inspected to determine whether the chemical has been
produced for commercial purposes and whether an NOC was submitted.  They should also be checked
for  compliance with terms of the Section 5(e) order,  including all personal protective and  hazard
communication provisions. The circumstances of the Section S(e)/(f) order must also be considered when
looking at Section 5(e)/(f) orders  as an inspection targeting mechanism.  Section 5(e) orders can be
grouped into two categories in descending order of priority:

  • Orders with an NOC.  If manufacture has commenced, more risk to human and environmental
     health will be present than when manufacture has not commenced.  Section 5(e) and 5(0 orders
     regulate  high-risk  chemicals and  often will have provisions requiring the  use of personal
     protective  clothing and  respiratory  protection,  and/or particular hazard  communication
     requirements.  This type of Section 5(e) order thus merits the highest priority.  An inspector can
     tell if manufacture has commenced by looking up, by PMN number, die date of commencement
     on the NOC printout.  The facility should then be targeted for an inspection in which the
     inspector  looks at,  among  other  things,  compliance with  worker  protection, hazard
     communication and restrictions on manufacturing, use, and  disposal,  as well as production

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     volume to see whether the testing trigger has been exceeded. It is also possible to search the
     Management Information Tracking System (MITS), Document and Personnel Security System
     (DAPSS), and the Confidential Business Information Tracking System (CBITS) to obtain this type
     of data.  MITS is available on-line through the Information Management Division's (IMD) Public
     Data Branch. If possible, the Project Manager in Office of Pollution Prevention and  Toxics
     (OPPT) for that particular PMN should be consulted prior to the inspection (see Chapter Three).
   • Orders without an NOC. If an NOC has not been received in the first year after the Section S(e)
     Consent Order was signed, the inspector will want to ascertain why an NOC was not filed. Has
     manufacture begun without notifying EPA? Depending on the chemical, this could be a very
     serious situation. Conversely, if manufacturing has not yet commenced, why not?  The inspector
     may consider obtaining this information through less labor- and resource-intensive means (such
     as a telephone call) prior to committing to a full on-site inspection.
23 J SIGNIFICANT NEW USE RULES
2.3.3.1  BACKGROUND
Section 5(a)(2) of TSCA authorizes EPA to determine that a use of a chemical substance is a "significant
new use."  EPA must make this determination by rule after considering all relevant factors, including
those listed in Section 5(a)(2).  Section 5(a)(2) factors generally relate to the extent to which a use
changes the volume of a chemical's production or the type, form, magnitude, or duration of exposure to
it. Once EPA determines that a use of a chemical substance is a significant new use, Section S(a)"(l)(B)
of TSCA requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before
they manufacture, import, or process the chemical substance for that use.

Persons subject to a SNUR are required to comply with the same notice requirements and EPA regulatory
procedures as submitters of PMNs under Section S(a)(l)(A) of TSCA. In particular, these requirements
include the information submission requirements of Section 5(b)  and (d)(l), the exemptions authorized
by Section 5(h)(l), (2), (3), and (5), and the regulations at 40 CFR Part 720.  EPA may take regulatory
action under Section 5(e), 5(f), 6, or 7 to control the activities for which it has received a SNUR notice.
If EPA does not take action, Section 5(g) of TSCA requires  EPA to explain in the Federal Register its
reasons for not taking action.  It should be noted that a SNUR potentially has a broader application than
the PMN regulations because it applies to processors, as well as manufacturers and importers.

2.3J.2  EXPERIENCE
There has been very little experience with SNUR inspections.  Only one inspection has taken place to date
(in FY 1991); it did not result in any enforcement action as yet.


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2 J J J  TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS
Violations involving SNURs would be very similar to PMN violations, especially for non-reporting.
SNURs can be divided into three general categories:

   •  Section Sfe) SNURs.  A SNUR can be used to effectively extend the terms of a Section 5(e)
     consent order to all other manufacturers, processors, and importers based on the finding that
     any "use" other than those allowed in the Section 5(e) consent order could significantly
     increase exposure.
   •  Non-section 5fe) SNUR.  EPA will promulgate a SNUR only if the substance meets one or
     more of the concern criteria listed in 40 CFR §721.170(b). Essentially, these criteria call for
     a SNUR if exposures likely to result from new uses not in the PMN would have called for a
     Section 5(e) order if they had been in the PMN.
   •  Existing chemical SNUR.  A substance is already in commerce when EPA becomes aware of
     a use or uses that could significantly increase human exposure to the substance. The SNUR
     applies to all manufacturers, importers, and processors, even those who may already be using
     the substance.

SNUR violations may also occur within areas that overlap regulatory programs.  The "Generic SNUR"
promulgated at 40 CFR Part 721, establishes five categories of standard significant new uses, two of
which cross over into areas that have traditionally been within the purview of the Occupational Safety and
Health  Administration  (OSHA)  (Protection  in  the  Workplace,  Section   721.63,  and  Hazard
Communication, Section 721.72).  Section 721.63  designates as  a standard significant new use any
manner of manufacturing, importing, or processing associated with any use of the chemical substance if
the manufacturer, importer, or processor has not established a program whereby each person who is
reasonably likely to be exposed to the chemical is provided with and required to wear appropriate
personal protective equipment.   Section 721.72 designates as a standardized significant new use any
manner or method of manufacture, import, or processing associated with any use without establishing a
hazard communication  program.  Most provisions  of this  section parallel those of OSHA's Hazard
Communication Standard (HCS) except that EPA's rule differs in five respects:  (1) EPA makes the
hazard determination, rather than the employer; (2) EPA provides language for labels and material safety
data sheets, whereas OSHA allows employers to develop language; (3) EPA does not provide trade secret
protection as does OSHA's HCS; (4)  EPA requires listing of environmental  hazards on labels and
Material  Safety Data Sheets  (MSDSs), whereas OSHA  does not; and (5) under the  SNUR hazard
communication program, EPA can require labeling, etc., based on a finding that a substance may present
a risk, whereas OSHA's hazard communication restrictions generally apply to chemicals that are known
to present certain hazards.

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Inspection targeting for SNURs will focus on two primary areas: (1) failure of manufacturers, importers,
or processors to submit a SNUN (either for new or existing substances and in relation to a Section 5(e)
order); and (2) "generic SNUR" inspections (targeting and/or inspections could be done in cooperation
with OSHA). For example, when inspecting a company for compliance with Section 5(e) orders that have
been followed up with SNURs, an inspector can make note of the company's customers while reviewing
their records for the order. If a processor/customer is found, that processor/customer is subject to
required recordkeeping under 40 CFR §721.125 and to any use restrictions of the SNUR itself.

2.3.4 PMN EXEMPTION APPLICATIONS
2J.4.1 BACKGROUND
The previous Section described the PMN (Section 5) process. TSCA Section 5 also provides several
exemptions from the requirement to submit a full PMN. Exemptions exist for low volume production
(LVE), test marketing (TME), research and development (R&D), polymers (PE), and chemicals used in
instant photographic films (Instant Film Chemical Exemption or IFCE). In most cases, an application
and EPA review are required to obtain an exemption, but these are less onerous than those for a full
PMN. In practice, discussions of exemptions generally deal with LVEs, PEs, and TMEs, because R&D
exemptions require no application (although the company must comply with recordkeeping requirements),
and because the photographic film exemption applies to only a few firms.

The historical data in Table 2-3 provide some perspective on the size of the exemption program. From
1985 to 1991, the regulated public submitted 237 TME applications (or about 34 per year), 1,549 PE
applications (or about 221 per year), and 1,941 LVE applications (or about 277 per year). For all years
combined, exemption applications make up nearly 20 percent of new chemical submissions to EPA. No
information is available on R&D exemptions because applications are not required.

Table 2-1A shows the numbers of inspections undertaken by EPA by type of inspection for each year
since 1986. Inspections initiated to evaluate compliance with PMN exemptions account for only about
3.5 percent of EPA's inspection activity. Furthermore, these were concentrated in 1988 and 1989 and
in Regions n, m, and V. Of 74 exemption inspections conducted, only 3 resulted in actions (see Table
2-IB). In terms of past inspection activity, exemptions have not been a large or important part of the
inspection and enforcement program.
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2.3.4.3 TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS

There are several types of exemptions and several mechanisms by which EPA can identify potential

violations. Regions may consider exemption applications as a lower priority than other categories of

potential violations because exemptions are offered for categories of chemicals or activities that present

lower risk of environmental harm than other categories. For example, LVEs deal only with low volumes

of chemicals, PEs apply only to chemicals of certain specifications that are expected to pose low risk,

and TMEs apply to chemicals to be test marketed for some limited time period. In the case of TMEs,
one may expect either that the test period will be followed by market failure and hence no use, or market

success and expanded use triggering a full PMN.

However, it is important to verify compliance with restrictions on the testing period and maximum

production quantity, to maintain an enforcement presence, and to ensure that the exemption process is

not being abused. Abuse may be most likely in the low volume and research and development areas.

There are several mechanisms by which EPA can identify potential violations.

• Denied or invalid exemption applications without PMN following. This may be a useful category
to target because the firm was apparently poised to manufacture, but was denied the venue of an
exemption. After denial, the firm could go through the PMN route, could terminate plans to
manufacture, or could manufacture illegally.

• Withdrawn exemption applications. As with withdrawn PMNs, facilities that have withdrawn
exemption applications have not necessarily done anything wrong. However, if there is some reason
to inspect "for cause" (e.g., because the facility may have manufactured without an approved
exemption or PMN), then it would be more serious. Inspectors should always check to see whether
a PMN was submitted after the exemption application was withdrawn.

• Multiple exemption applications. Multiple exemption applications may indicate some of the same
problems as multiple PMNs. The submitter may have recently become aware of TSCA rules and
is trying to come into compliance for past violations. On the other hand, multiple applications may
indicate that a lot of activity is occurring at the facility and that it should be investigated.

• Active/granted exemptions. For granted applications, submitters are bound by the conditions in the
exemption document. The inspector may want to target facilities that have exemptions with
restrictions. These restrictions, or conditions, should be verified when the inspector is on site.

2.3.5 PREMANUFACTURE NOTIFICATION (PMN)

2J.5.1 BACKGROUND

TSCA Section S(a) requires all chemical manufacturers and importers to notify EPA 90 days before
manufacturing or importing a new chemical substance. During the 90-day period (or 180 days if EPA
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requests an extension), EPA reviews the information in a PMN to determine whether the substance
presents or may present an unreasonable risk to public health or the environment. Based on this review,
EPA has the authority to take action to control use or handling of the substance and prevent large-scale
distribution. If EPA takes no action to limit use or delay the review period, the submitter may begin
production, but must submit an NOC within 30 days of commencement of manufacture or import for a
non-exempt commercial purpose. If EPA chooses to regulate use or production of the substance, a
Section 5(e) order will be issued (as discussed in Section 2.3.2). The submitter may withdraw its PMN
at any time during the review process without giving a reason. In addition, there are several mechanisms
by which a manufacturer or importer can be exempted from the full PMN reporting requirements. These
are discussed in Section 2.3.5.

2.3.5.2 EXPERIENCE
A brief review of historical data will provide some perspective on the size of the PMN program and
EPA's inspection program. Table 2-3 shows that as of 1991, on average, 1,707 PMNs have been
submitted to EPA each year since 1986, with a total of 15,906 since 1979. Of these 15,906, 7,567 (or
almost 50 percent) have been followed by NOCs, 504 have been followed by Section 5(e) orders, and
779 have been withdrawn in the face of regulatory action.

Table 2-1A shows the numbers of inspections undertaken by EPA by type of inspection for each year
since 1986. Inspections initiated to evaluate compliance with PMN requirements account for a large pan
of EPA's TSCA inspection activity. They accounted for about a third of the 990 inspections conducted
under TSCA -Section 5 in the period from 1986 to 1991. Table 2-1B shows 82 cases where PMN
violations resulted in some type of action, such as an administrative order, to correct a violation.
Although PMN inspections represent only a third of the total Section 5 inspections, PMN violations
account for over half of the violations found in all Section 5 inspections.

2J.5.3 TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS
There are several mechanisms by which EPA can identify potential violations. These are described in
order of relative importance.

• PMNs withdrawn in the face of regulatory action. If EPA requests information or data that
indicates an intention to regulate use or production of the substance, the submitter is permitted to
withdraw the PMN. This may indicate that the firm is trying to avoid regulatory or informational
burdens and may manufacture without approval. Manufacturing without approval would be a
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potentially serious violation because EPA was in the process of deciding that the substance
represented a sufficient environmental or health risk to warrant control.

• Multiple PMNs in a short time period. Several PMNs may be submitted at the same time if the
submitter was not aware of the notification requirement or "discovered" substances in use that were
not on the inventory. This situation may indicate that production was already occurring before the
PMN was submitted and that someone was trying to cover up past violations. This would be a
potentially serious violation because EPA would have had no opportunity to review the
characteristics of these substances, which could represent an environmental or health risk.

• PMNs with earlv NQC. If an NOC is submitted within a few days^of the expiration of the 90-day
PMN review period, it may indicate that the firm was not waiting for a response from EPA, but
was already manufacturing.

° Withdrawn PMNs (with no anticipated action). There may be several reasons for a manufacturer
to withdraw a PMN: there may be no market for the product; existing chemical replacements may
have been found; or EPA data requests may be too onerous for the projected profitability of the
chemical. This should be a low priority unless there is some other reason to believe that the
company is actually manufacturing.

• PMNs with no NOC. after review period has passed. As with withdrawn PMNs, the lack of an
NOC of manufacturing may simply indicate that the firm found that the product would not be
profitable for a variety of reasons, but that the company wants to retain the option to begin
production. This situation should be a low priority unless there is reason to believe that the
company is actually manufacturing, perhaps because of a tip, complaint, or other information.
23.6 TSCA SECTION 8

2J.6.1 BACKGROUND
TSCA Section 8 consists of five subsections that establish reporting and recordkeeping requirements, as
described in Chapter 1. Chemical manufacturers, processors, and/or distributors may be required (unless
exempt) to submit reports and/or maintain records under Section 8. While' all Section 8 requirements are
important, it is difficult to target a facility for some of them because EPA does not maintain any formal

records or databases covering each of the subsections of Section 8 [e.g., Section 8(c)J. Because of this,

the following targeting section will only address the four Section 8 rules for which EPA databases exist:

Preliminary Assessment Information Rule (PAIR) and Comprehensive Assessment Information Rule
(CAIR) [Section 8(a), Inventory Update Rule (IUR) [Section 8(b)], and Section 8(d). Based on EPA HQ

guidance in the 1993 MOA process, Section 5 inspections are generally considered higher priority than

Section 8 inspections.
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2.3.6.2 EXPERIENCE
The following section provides an overview of the number of inspections and enforcement actions related
to PAIR, CAIR, IUR, or Section 8(d) that EPA has handled in the past six years.

Historical data provide perspective on the size of the PAIR, CAIR, and IUR inspection programs.
Between 1986 and 1991, EPA conducted 173 PAIR inspections (see Table 2-1 A). The most inspections
known to be conducted between 1986 and 1991 in one year (i.e., 32) occurred in 1989, and the fewest
known occurred in 1986 (i.e., 14). PAIR inspections constitute 8.1 percent of total TSCA inspections.
Table 2-2A shows only four Regions (Regions II, III, V, VII) and OCM and/or NEIC have conducted
inspections for compliance with PAIR. Regions n and III are responsible for the majority of these
inspections (63 and 82 inspections, respectively). From these inspections, 22 PAIR enforcement actions
(10 percent of total enforcement actions) have occurred (see Table 2-1B). No information is available
on CAIR inspections.

From 1986 to 1991, EPA performed 342 IUR inspections (Table 2-1A). These inspections evaluating
compliance with IUR accounted for 16 percent of the total TSCA inspections, and almost 30 percent of
Section 8 inspections. Table 2-2A indicates that Regions n, III, and V conduct the majority of IUR
inspections. EPA has pursued 43 IUR enforcement actions since 1986. Over SO percent of the total
Section 8 enforcement actions stem from IUR actions.

Data concerning Section 8(d) will also provide some perspective on the size of its inspection program in
relation to the rest of Section 8 and Section 5 inspections. Since 1986, 73 inspections have been
conducted and all occurred in Regions II, III, and V (See Table 2-2A). Section 8(d) inspections account
for 3.4 percent of the total TSCA inspections.

2 J.6 J TYPES AND POTENTIAL SERIOUSNESS OF VIOLATIONS
Section 8 inspections tend to occur in conjunction with Section 5 inspections, although the Section 8
inspection is usually secondary. However, noncompliance with Section 8 can result in harm to health
or the environment. Mechanisms exist that EPA may use to identify potential violations of PAIR, CAIR,
and IUR, including the following:

• Nonreporters. PAIR and CAIR nonreporting is a serious violation because the chemicals subject
to these rules are, by definition, of higher concern to EPA than other chemicals on the Inventory.
EPA is trying to fill data gaps for these chemicals through information collection. Unfortunately,

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identifying nonreporters is a difficult task (see Section 2.3.1). To target potential non-reporters,
the inspector should verify that the facility in question reported to the initial Inventory and compare
it to the lists of facilities reporting under PAIR, CAIR, or the IUR. Review of the Toxics Release
Inventory (TRI) submittals together with IUR submitter information may also generate potential
PAIR and CAIR targets for those chemicals subject to such reporting requirements.
• Late reporters. While late reporting is not as serious as nonreporting, it could be an indication of
other violations. PAIR, CAIR, and IUR set reporting dates, after which a facility would be in
violation of TSCA regulations.
2.3.7 OTHER POTENTIAL TARGETING MECHANISMS
To increase the effectiveness of the TSCA compliance monitoring program, the regulated community
needs to be accurately identified and characterized. Because the TSCA program has been in place for
more than 15 years, the TSCA regulated community is relatively well known. Unfortunately, the large
size of the program and limited EPA resources restrict the ability to do widespread compliance
monitoring. Thus, targeting die regulated community to increase the efficient use of resources to conduct
compliance monitoring is essential. Section 2.3 addresses each significant TSCA regulatory program and
outlines the targeting methods used historically for compliance with existing resources. Recently, other
targeting mechanisms have been suggested. Although there is limited experience with these mechanisms
in the TSCA program, they could be used with more program development and changes of emphasis to
risk. This section, however, outlines other potential targeting mechanisms for the general TSCA program
and not necessarily for specific programs.

Descriptions are provided to stimulate discussion and pilot trials at the Regional level. These are not
specified as policy, but as potential tools to be used. Some of these tools are beyond the scope of
Regional targeting, but some elements could be incorporated into ongoing activities. These general
targeting mechanisms include the following:

• Tips and complaints
• Multi-media targets
• High-risk chemicals
• Geographic targets.
November 1992 2-20 TSCA fifi 5/8 Inspection G

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Chapter Two	Targeting TSCA Sections Sand 8 Inspections

23.1.1  TIPS AND COMPLAINTS

Tips and complaints continue to be a top priority with Headquarters. Although tips and complaints may
be submitted by anyone, the main sources of information include referrals from the Office of Prevention,

Pesticides, and Toxic Substances (OPPTS), other Regions, and industry. Headquarters forwards all tips

and complaints to the appropriate Region as Investigation Requests. Tips and complaints are expected

to be the highest noncompliance rate group and deserve the highest priority.


Tips and complaints from the public are not as common under TSCA  as for other EPA programs such

as RCRA  and Superfund.  This is because it is more difficult to "see" a violation under TSCA (e.g.,

failure to submit a PMN) than violations in outer media. There are organizations that potentially couid
provide tips and complaints under TSCA and thus  bring potential violators to the EPA's attention.
However, for tips and complaints to be useful and successful, the public and regulated community need
to be educated as to what may constitute a TSCA violation.  Examples of potentially useful compliance
education projects include public service announcements, presentations at conferences and meetings, and
public information pamphlets. Such ideas like the ones described here could be implemented as a joint

pilot program with Headquarters and Regional participation.


   • Industry could be a major source of tips alleging violations under TSCA. Industry could be made
     aware that those firms  that violate the requirements of TSCA  are operating at  an economic
     advantage over those companies acting in a responsible manner.   An educated industry might be
     willing to provide tips to the EPA to prevent this economic advantage. Industry has the resources,
     expertise, connections,  and  motivation  to ensure that other companies  act responsibly.   By
     capitalizing on this situation, the EPA could better target its resources  toward non-complying
     companies.

   • Labor unions have quickly become  a powerful force in promoting compliance within individual
     companies.  Unions should be instructed that those workers simply following orders but violating
     TSCA are not necessarily excused from potential civil or criminal penalties if there is just cause.
     In addition, unions could be made aware that their members' health and safety may be threatened
     when noncompliance  with TSCA occurs.  Unions need to be  trained to fully understand  the
     requirements of Section 8(c), allegations of adverse reactions, and 8(e), notice of substantial risk.

   • Public interest groups are less likely to provide tips and complaints than industry and unions because
     they have less  access to information.  However,  environmental groups tend to  be vigilant and
     knowledgeable  about environmental statutory and  regulatory compliance.  Their existence is an
     important element in ensuring the success of the Section 8(c) program. Therefore, education efforts
     could focus on their rights under Section 8(c).  Although similar in nature to environmental groups,
     citizen groups tend to be less sophisticated concerning knowledge of the statutory and regulatory
     programs. Whereas environmental groups benefit from national organizations, citizen groups tend
     to  be local in nature.  Nevertheless, their support could be valuable, and education concerning
     Section 8(c) should be considered.
TSCA 55 5/8 Inspection Guidance            2-21                              November 1992

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Targeting TSCA Sections 5 and 8 Inspections Chapter Two
2J.7J MULTI-MEDIA TARGETS
The purpose of multi-media compliance inspections is to assess compliance with a number of applicable
Federal environmental statutes in single visits. A multi-media inspection can involve dual or multiple
program compliance inspections. This approach can effectively use investigatory personnel to reduce
multiple visits to the same facility. Thus, a multi-media compliance inspection may audit a facility's
chemical manufacturing process, wastewater discharges, hazardous waste management program, and air
emissions with a team of specifically trained inspectors. Multi-media inspections are not necessarily
meant to be all-inclusive. In fact, some inspectors may not be specifically assigned or trained under a
program (e.g., TSCA). In this situation, such an inspector would be in a position to refer potential
violations to the appropriate program.

EPA's National Enforcement Training Institute, NEIC, has developed training programs for multi-media
inspections. The inspector training consists of four levels. Level 1 is for single program inspections;
Level 2 is training to screen for and report on the more obvious or key indicators of noncompliance in
all environmental programs areas relevant to a particular facility; Level 3 training is for multi-program
inspections to train lead inspectors for two or more compliance programs; and Level 4 training is for an
i
inspector to lead a team or conduct either a multi-media or multi-program inspections for a facility or
site. By training compliance inspectors in this manner, referrals resulting from other activities and
programs could significantly increase the success of the targeting program.

In addition, the TSCA program can use information available through other EPA regulatory programs
to identify potential violators. Firms that are permitted, regulated, or inspected under other EPA
programs provide information regularly to EPA under the reporting provisions of the several
environmental statutes. In addition, EPA regularly collects information on these firms through
investigative efforts and enforcement actions. Some of this information may help the TSCA program to
identify facilities for inspection. In return, the TSCA program may be able to provide useful information
to other program areas from the non-confidential business information (CBI) it maintains. At the
Regional level, inspectors could provide summaries of inspection results to other programs routinely, or
provide more specific information when potential violations in other program areas are discovered in
individual inspections.

One excellent source of information kept by various EPA offices is the Integrated Data for Enforcement
Analysis (IDEA) System. This system is described in detail in Section 2.4.6.
November 1992 2-22 TSCA §8 5/8 Inspection Guidance

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Chapter Two Targeting TSCA Sections 5 and 8 Inspections
2.3.7.3 HIGH-RISK CHEMICALS
Some Regions have suggested that high-risk chemicals need to be targeted because they present the
greatest threat to health and the environment. The PAIR and CAIR are designed to gather information
on high-risk chemicals, so the targeting procedure described in Section 2.3.6 will address this issue to
some extent. In addition, there are a number of sources that publish lists of high-risk chemicals. Based
on these lists, Regions could determine whether these chemicals are produced and at what quantities to
determine targeting effort. Sources for identifying high-risk chemicals include the following:

• Interagency Testing Committee (ITO. Established by Section 4(e) of TSCA, the ITC makes
recommendations to EPA concerning which chemicals should be given priority by EPA for the
development of test rules. The ITC revises the Priority List, which consists of no more than SO
priority chemicals, every 6 months and publishes it in the Federal Register. These chemicals will
men become subject to PAIR and Section 8(d).
• EPCRA Section 313. Section 313 of EPCRA, the Emergency Planning and Community Right-to -
Know Act, requires regulated facilities to report releases of designated toxic chemicals to EPA. The
information must include the amount and destination of the release of the toxic chemical. Regions
could access the TRI database to determine which toxic chemicals are being released and where.
This could also assist in geographic-based targeting inspections.
• Clean Air Act Amendments. These amendments included a statutory list of 189 air toxics that
require regulation. They have been identified as potentially causing a significant risk to human
health and the environment.
• Clean Water Act. The Clean Water Act list of priority pollutants and the RCRA program listed
wastes provide potential chemicals of concern that could be investigated in the TSCA program.

23.7.4 GEOGRAPHIC-BASED TARGETING
Region m and Region V, in their FY 1991 Core TSCA Inspection Schemes, identified geographic
targeting as a method to be used to focus inspection activity. For example, the Chesapeake Bay and the
Kanawha Valley areas have been identified through the Toxic Release Inventory database as areas
threatened by toxic chemicals. However, other geographic identifications, such as priority waterbodies
or non-attainment areas in the air program, could be used as the basis for similar targeting schemes.
Targeting a percentage of inspections on non-submitters in geographic areas of concern would be a simple
criterion to impose, after identifying potential facilities to be inspected by other means.

2.4 INFORMATION SOURCES
This section introduces a variety of information sources that are available for identifying facilities
potentially subject to TSCA requirements. Several databases maintained by EPA/IMD form the core of
TSCA H 5/8 Inspection Guidance 2-23 November 1992

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Targeting TSCA Sections 5 and 8 Inspections	Chapter Two
the TSCA targeting effort and the information sources discussed here.   The Office of Compliance
Monitoring is expected to provide targeting data to Regional inspectors on a semiannual basis.  This
targeting information  is prepared by  IMD at the  request of OCM, as described  in the  example
memorandum found hi Appendix 1.  Table 2-4 summarizes the information contained in these printouts.
The following section discusses information sources for targeting facilities for the specific TSCA sections
or regulations. Information sources for non-submitters are discussed at the end of Section 2.4.  Although
a variety of sources are available to assist in identifying potential non-submitters,  it is not possible to rely
solely on one mechanism at this tune.

2.4.1 TSCA SECTION 5(e)/(f)
The information relevant to potential Section S(e)/(f) violations appears in CBI  Printouts A and D and
Non-CBI Printout I described in Table 2-4.  CBI Printout A contains information  on  all submitters of
information under Section 5 by plant site address, including contact name, telephone, site address, and
submission number.  CBI Printout D contains information on withdrawn PMNs and those that  were
followed by a Section 5(e)/(f) order, listed by address. 'Information presented includes company name
and address, contact information, date and disposition of the PMN, and the chemical  name.  Potential
inspection targets should be readily identifiable from this printout.  A more detailed summary of the
information to be provided regularly and examples of targeting printouts appear in Section 2.4 of this
chapter.

Non-CBI Printout I contains information on the dates of PMNs and NOCs, including case number, end-
date of PMN review period, date of NOC (if any), number of elapsed days since the  end of the PMN
review period, and plant address and company name. This information can be  sorted  by Region or by
PMN case number.

The Compliance Division of OCM  is expected to forward all Section S(e) and  (f)  orders and their
underlying PMNs to the Regions where the plant sites are located so that Regional inspectors can target
these facilities.  In practice, most CBI data are not yet available for Regional use,  but can be obtained
through an enforcement request (see Section 2.4 and Appendix 2).

2.4.2 SNURs
The means of obtaining information on which facilities are manufacturing SNUR chemicals has not yet
been resolved. One information source is the customer list of current manufacturers, as discussed above
under Section 5(e), or the inspector may ask, during an inspection, if the company has ever submitted

November 1992                             2-24            TSCA fi§ 5/8 Inspection Guidance

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Chapter Two
     Targeting TSCA Sections 5 and 8 Inspections
       TABLE 2-4 INFORMATION AVAILABLE IN TARGETING PRINTOUTS
                        FROM IMD THROUGH OCM
TITLE OF PRINTOUT
r
CBI Printouts
A. TSCA Section 5 Submitter
Information
B. PAIR Submitter Information
C. IUR Submitter Information
D. Withdrawn PMNs or PMNs
Followed by §5(e)/(f) Order
E. Withdrawn, Denied, Invalid
TMEAs Information
F. Withdrawn, Denied, Invalid
LVEAs Information
G. Withdrawn, Denied, Invalid PEAs
Information
H. CAR Submitter Information
N<»^1 Printouts .
I. PMN/NOC Information
I. TSCATS Information
DESCRIPTION OF INFORMATION AVAILABLE
Contain Confidential Business Information
Includes Region, Company Name, Technical Contact, Telephone
Number, Plant Site Address, and Submission Number, Sorted by
Plant Site Address, Region, and Zip Code.
Includes Company Name, Technical Contact, Telephone Number,
Plant Site Address, Submission Number, CAS Number, and
Chemical Number, Sorted by Plant Site Address, Region, and
Zip Code.
Includes Company Name, Plant Site Address, DUNS Number,
UPD-From Number, Postmark, Identifying Number, Chemical
Name, Production Volume, and Manufacturer/Importer Status;
Sorted by Plant Site Address, Region, and Zip Code.
Includes Region, PMN Number, Company Name, Technical
Contact, Telephone Number, Plant Site Address, Date Received,
NOC Date, Disposition Date and Code, and Chemical Name;
Sorted by Plant Site Address, Region, and Zip Code.
Includes Region, PMN Number, Company Name, Technical
Contact, Telephone Number, Plant Site Address, Date Received,
NOC Date, Disposition Date and Code, and Chemical Name;
Sorted by Plant Site Address, Region, and Zip Code.
Includes Region, PMN Number, Company Name, Technical
Contact, Telephone Number, Plant Site Address, Date Received,
NOC Date, Disposition Date and Code, and Chemical Name;
Sorted by Plant Site Address, Region, and Zip Code.
Includes Region, PMN Number, Company Name, Technical
Contact, Telephone Number, Plant Site Address, Dale Received,
NOC Date, Disposition Date and Code, and Chemical Name;
Sorted by Plant Site Address, Region, and Zip Code.
Includes Company Name, Technical Contact, Telephone Number,
Plant Site Address, Submission Number, CAS Number, and
Chemical Number; Sorted by Plant Site Address, Region, and
Zip Code.
Contain Non-Confidential Business Information
Includes Case No., End-dale of PMN Review Period, NOC Date,
No. of Elapsed Days Between these Two Dates, Plant Site State
and City, and Company Name; Sorted by Region and PMN
Number.
Includes Region, Dunn & Bradstreet Number, CAS Number,
Chemical Name, TSCA Section, Title of Study, Date Received,
Submitter Name, and Plant Site Address.
TSCA H 5/8 Inspection Guidance
2-25
November 1992

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Targeting TSCA Sections 5 and 8 Inspections Chapter Two
any SNUNs. A check of the Chemicals on Reporting Rules (CORR) list will also reveal whether any of
a company's products are the subject of SNURs. It should be noted that the CORR list is prepared by
chemical identity, not by manufacturer, so it will be less useful for targeting than for checking
information about specific products of specific companies.

2.43 PMN EXEMPTIONS
Referring again to Table 2.4, the information relevant to exemption applications appears in CBI Printouts
A, E, F, and G. CBI Printout A contains information on all submitters of information under Section 5
(that is, PMNs and all exemption applicants) by plant site address, including contact name, phone, site
address, and submission number. This printout would be useful for identifying firms with multiple
submissions and for finding the submission number to cross-reference to other printouts.

CBI Printout E contains information on withdrawn, denied, or invalid TME applications. CBI Printout
F contains information on withdrawn, denied, or invalid LVE applications. CBI Printout G contains
information on withdrawn, denied, or invalid PE applications. Each of these printouts contains
information on company name and address, contact information, date and disposition of the application,
and the chemical name, sorted by address. Firms identified on printout E, F, or G can be cross-checked
to printout A to see whether a PMN followed denial of the exemption application.

2.4.4 PMNs WITHDRAWN
The information relevant to potential PMN violations appears in CBI Printouts A and D and in Non-CBI
Printout I. CBI Printout A contains information on all submitters of information under Section 5 by
plant site address, including contact name, phone, site address, and submission number. This printout
would be useful for identifying firms with multiple submissions and for finding the PMN submission
number to cross-reference to other printouts.

CBI Printout D contains information on withdrawn PMNs and those that were followed by a Section
5(e)/(f) order, sorted by address. The information presented includes company name and address, contact
information, date and disposition of the PMN, and the chemical name.

Non-CBI Printout I contains information on the dates of PMNs and NOCs, including case number, date
of end of PMN review period, date of NOC (if any), and number of elapsed days from the end of the
review period to the receipt of the NOC, as well as plant address and company name. The same

November 1992 2-26 TSCA 5§ 5/8 Inspection Guidance

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Chapter Two Targeting TSCA Sections 5 and 8 Inspections

information is presented in two forms, sorted by Region and sorted by PMN case number, to facilitate

searching from either starting point. This printout would be useful for identifying PMNs with early
NOCs (or with no NOCs).

Another information source relevant to PMNs is the PENTA (Section 5) System, maintained by the

Information Management Division of OPPT. The PENTA System contains information and analyses

considered during EPA's review of PMN submissions. The database can be searched by facility (e.g.,

by address, by DUNS number), rather than just by chemical. Most of the data are CBI, and this database

is not yet available for Regional use. However, information from this database can be obtained through

an Enforcement Request (ER). The procedures for making an ER are outlined in Section 3.2.4.

2.4.5 TSCA SECTION 8 TARGETING

As discussed previously, there is no single automated data system for tracking Section 8 submissions and
targeting potential violations. However, IMD maintains several automated databases that may help in
gathering information on potential targets.

• £US. The Chemical Update System (CUS) contains all of the Inventory update information. EPA
is currently updating CUS since the last IUR reporting period ended February 21, 1991 (extended
from December 23, 1990). Inspectors can search this database, by facility, for IUR submitter
information, such as the chemical names and CAS Registry Numbers reported. Searches should
also reveal companies that submitted a late IUR form. Regions were provided information on
submitters under the 1986 and 1990 IUR on diskette in April 1992.

• EAJR. The PAIR 8(a) Level A database houses all the data collected on PAIR-regulated chemicals.
Inspectors can search this database for PAIR submitter information such as manufacturing location,
company name, chemical name, and CAS Registry Number reported.

• £AJ&. The CAIR database includes detailed production, raw materials, processing, use,
environmental fate, worker exposure, environmental release, physical and chemical properties, and
waste generation and handling data on listed chemicals.

• ISCAIS. The TSCA Test Submissions (TSCATS) database lists all persons who have supplied
EPA with copies of Section 8(d) studies. This database also includes a listing of all Section 8(e)
reports to EPA.

Information in these data systems for specific facilities can be accessed through an Enforcement Request.
TSCA fift 5/8 Inspection Guidance 2-27 November 1992

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Targeting TSCA Sections 5 and 8 Inspections	Chapter Two
2.4.6 MULTI-MEDIA
The TSCA program can use information available through other EPA regulatory programs to identify
potential violators.  In addition, each EPA media program regularly collects information on these firms
through investigative efforts and enforcement actions.  EPA's Office of Enforcement has developed the
Integrated Data Enforcement Analysis (IDEA system) for integrating and analyzing cross-program
information from the many databases maintained by EPA for enforcement targeting, screening, and multi-
media initiatives. The  User's Guide to the IDEA System, dated August 2, 1991, from the Office of
Enforcement, provides instruction on how to access the system through the EPA National Computer
Center (NCC) IBM mainframe.  Since the system allows the user to obtain enforcement-sensitive
information, access is limited and special authorization is required. Even without this access, however,
the Guide is valuable because it provides a list of the data elements available in the following databases:

   •  Aerometric Information Retrieval System (AIRS) Facility Subsystem (AFS)
   •  Comprehensive Environmental Response,  Compensation, and Liability  Information  System
     (CERCLIS)
   •  Civil docket
   •  Facility Index System (FINDS)
   •  Federal Facility Index System (FFIS)
   •  Hazardous Waste Data Management System (HWDMS)
   •  Permit Compliance System (PCS)
   •  Resource Conservation and Recovery Information System (RCRIS)
   •  Toxic Release Inventory (TRI)
   •  National Compliance Database (NCDB).

Even without access to NCC, these databases may be accessed directly and locally in  most cases by
Regional personnel in the appropriate program office. The information in these media databases could
be used directly for targeting or indirectly for ranking facilities within targeting categories. This process
is discussed in more detail in Section 2.5.
November 1992                              2-28            TSCA 55 5/8 Inspection Guidance

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Chapter Two Targeting TSCA Sections 5 and 8 Inspections
2.4.7 NON-SUBMITTERS
Finding non-submitters is perhaps the most difficult task in targeting TSCA violations. This is because
there are thousands of chemicals, manufacturers, processors, and importers of chemical substances.
Many of the non-submitters are discovered through voluntary disclosure on the part of the company.
However, most non-submitters probably go undetected. A variety of information sources are available
that can assist in identifying potential non-submitters. The tools that can provide assistance include the
following three computerized information sources:

* FACTS (Facility and Company Tracking System)
• FINDS (Facility index System
• TRIS (Toxic Release Inventory System).

In addition, EPA's IDEA System provides access to FINDS and TRIS. These systems are described in
detail in Section 3.2.3.1.

Directories and trade associations also can identify companies engaged in TSCA-related chemical
manufacturing and/or importing. Sources include:
Directory of Chemical Producers
Chemical Week
Chemical Marketing Reporter
Chemical Week's Buyer's Guide
American Importers Association Directory
Registry of American Importers and Exporters.
These documents are available in many libraries. Information from other agencies includes the OSHA
Industry List and U.S. Customs brokers licensed by geographic region of principal operation. Internally
generated information may include tips and complaints from other offices within EPA and customer and
supplier lists from previously-inspected TSCA facilities.

The following section describes how information developed from these various sources can be used to
develop a master list of potential facilities to be inspected and how individual facilities can be selected
(targeted) from the master list.
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Targeting TSCA Sections 5 and 8 Inspections Chapter Two
2.5 SETTING PRIORITIES AND SELECTING SPECIFIC TARGETS
This section revisits the main targeting steps outlined in the flowchart (Figure 2-1) and provides more
detail on how to proceed from identification of facilities with potential violations to selection of specific
facilities for investigation. A two-step framework is developed to serve as a model for prioritization and
selection.

2.5.1 DEVELOPING A MASTER LIST
The procedures and criteria in Section 2.3 and the information sources in Section 2.4 should be used to
identify all facilities that may warrant inspection. This may result in many dozens of potential inspectees,
which form the master list. Because it is unlikely that thorough inspections can be conducted at each of
these facilities in one fiscal year, it is necessary to select a subset of individual facilities, based on
Regional priorities and resource constraints.

232 SETTING PRIORITIES AMONG TARGETING AREAS
Resources are a primary issue in determining which facilities to inspect. Staff availability, travel budgets,
competing assignments, and reporting schedules have to be factored into the decision of how many
facilities can be selected from the master list. Many of these decisions are normally made at the time that
STARS commitments are made in late summer. However, it is useful to re-evaluate resources and staff
availability at several points throughout the fiscal year.

The next step is to allocate the inspections across the areas of potential violation, discussed in Section 2.3.
Priorities among program areas will be decided at the Regional level with guidance from Headquarters,
based on the Memoranda of Agreement (MOA) process, and will vary over time and from Region to
Region. Several issues should be considered when priorities are being set. One issue is the distinction
between two types of priority-setting mechanisms, "targets" and "triggers." "Targets" are criteria or
weights assigned to guide selection of facilities to achieve a balance of inspections among different types
of potential violations. An example of a target in the form of a weighted allocation is "20 percent of
inspections should be selected from non-submitters." In contrast, "triggers" are events or circumstances
of sufficient concern that they warrant inspection, without regard to balance among other categories of
activity. For example, a Region may decide to conduct inspections at all facilities for which a tip is
received from Headquarters or all facilities subject to 5(e) orders. Targets can be used to set relative
priorities among inspection categories. Triggers, on the other hand, force a response to particular events.
November 1992 2-30 TSCA 55 5/8 Inspection Guidance

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Chapter Two Targeting TSCA Sections 5 and 8 Inspections
Each Region must consider the appropriate balance between targeting and triggering mechanisms, based
on Regional concerns and resources.

Because inspections are the basis of enforcement and case development, the process used for selection
of facilities necessarily influences the types and seriousness of violations found. Most Regions find two
conflicting objectives in conducting inspections and issuing cases. On the one hand, there is the need to
get as many cases issued as possible, to establish an enforcement presence, and to justify the program
internally and externally. This creates an incentive to seek out simple, fast inspection targets (and cases)
and do a lot of them. On the other hand, there is a need for big cases, with large penalties, national
publicity, and deterrent effects. These are typically complex, resource-intensive efforts. This creates an
incentive to seek out inspections (and cases) at large, complex facilities, perhaps with multiple plant sites
nationwide. Each Region will have to consider these conflicting incentive structures and strike an
appropriate balance when establishing a Regional targeting scheme.

Based on past experience and targeting documents, many Regions assign priority weights to different
sections of TSCA or areas of violation. For example, in its FY 1991 NAIS, Region HI decided to
allocate 10 to 20 percent of inspections to follow up tips and complaints, 10 to 20 percent to previous
year's leftovers, S to 10 percent to Section 5(e)/(f) orders and SNURs, and so on. In a similar scheme,
Region V allocated 20 percent of inspections in FY 1991 to particular geographic areas of concern.
Other Regions have experience with weighting based on coverage of past inspection activity. For
example, 20 percent of inspections may be allocated to facilities that have not been inspected in the last
2 years. Similarly, to increase coverage, a Region may want to allocate some proportion of inspections
to plants that were identified, but not inspected, in previous years.

These allocations will reflect Regional decisions and priorities. They may result in pan from past
experience, Headquarters guidance, and efforts to coordinate with other Regions or programs. The
discussions of individual targeting mechanisms in Section 2.3 address the potential seriousness of
violations in each category. This may provide some perspective that will assist the Regions in developing
relative rankings for directing inspection efforts. Headquarters guidance in the "OPPTS Regional
Priorities and Guidance for FY 1993 Memoranda of Agreement (MOAs),* dated June 24,1992, states:
...resources are to be used for priority inspection targeting non-submitters of PMNs (including
importers); parties to 5(e) risk-based orders; parties to SNURs; and holders of low-volume
exemptions.
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Targeting TSCA Sections 5 and 8 Inspections Chapter Two
These objectives should be factored into Regional targeting decisions. HQ will provide the Regions with
the 1993 MOA targeting priorities.

To assist Regional inspectors in targeting facilities, Figures 2-2 and 2-3 provide a framework for
consolidating and tabulating the results of a targeting scheme. It is provided as an optional tool that may
assist Regional personnel in evaluating alternative priorities or weighting systems. The worksheet is
completed for fictional Region A to clarify its use.

At the top of the form is a space for recording the total number of inspections planned by the Region.
This number results from internal resource decisions and commitments. This is the number of inspections
that can be allocated across the various inspection categories and target areas.

The left column includes all the targeting criteria discussed in Section 2.3. Column A, "Number of
Facilities Identified," can be completed by Regional personnel after reviewing the targeting printouts,
working files, databases, and other information developed during identification of potential targets. This
is a summary of the "master list" developed at the start of the targeting process (see Sections 2.3 and
2.5.1). Column B is used to record the weight assigned to each targeting criterion. For example, a
Region may want to allocate 40 percent of inspections to non-submitters. Column C is the product of
the number of planned inspections and the weight (percentage) assigned in Column B. Column C is the
number of inspections to be conducted in each targeting area; it is the number of facilities to be selected
randomly from the master list in each targeting area. This activity is discussed in the next section.

2.5.3 SELECTING SPECIFIC FACILITIES WITHIN TARGETING AREAS
Once priorities and budgets are set and the categories of inspections are determined, individual facilities
must be selected from within each targeting area on the master list. This can be done randomly or on
a prioritized basis. The objective of a NAIS is to ensure that there is a rational method of choosing
individual plants, so there is a justification and so that the same facilities are not inspected every year.
For random selection, one assigns a number to each facility in the category and uses a random number
generator (available on most calculators or in tables at the back of statistics books) to select facilities until
the Regional goal for inspections in that group is met.

For selection on a prioritized basis, Figures 2-4 and 2-5 provide another framework for selecting facilities
from within groups. The approach is based on a simple scoring system. It is intended to offer a quick
November 1992 2-32 TSCA 58 5/8 Inspection Guidance

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Chapter Two
     Targeting TSCA Sections 5 and 8 Inspections
                                FIGURE 2-2



           SETTING PRIORITIES (WEIGHTS) AMONG PROGRAM AREAS



                            Example Worksheet 1
   TOTAL NUMBER OF PLANNED INSPECTIONS

Targeting Criterion
Non-Submitters
5(e)/(f)
SNUR
PMN Withdrawn
PMN Exemption
PMWBona Fide
IUR
CAIR/PAIR
Other Section 8
Other
Tips/Complaints
Geographic
Multimedia
Chemical Risk
A
it Facilities
Identified on
Master List














>.
B
Targeting Weight
Assigned














C
# Facilities to be
Selected














Instructions:
1. The number of planned inspections is based on Regional resources, decisions, and
commitments.
2. Column A can be completed from the targeting printouts and working files used to
identify potential facilities *° be inspected.
3. Column B must be completed based on Regional priorities and concerns. It should
include the weight (percentage) assigned to each targeting criterion.
4. Column C is completed by multiplying the weight (percentage) in Column B by the
number of planned inspections found at the top of the page. Fractions should be
rounded.
5. Column C Is for the number of inspections to be selected randomly from each targeting
criterion.
TSCA H 5/8 Inspection Guidance
2-33
November 1992

-------
Targeting TSCA Sections 5 and 8 Inspections
                              Chapter Two
                                 FIGURE 2-3



                         TARGETING WORKSHEET 1



                             Example Worksheet 1
   TOTAL NUMBER OF PLANNED INSPECTIONS
                           10

Targeting Criterion
Non-Submitters
5(e)/(f)
SNUR
PMN Withdrawn
PMN Exemption
PMN/Bo/UJ Fide
IUR
CAIR/PAIR
Other Section 8
Other
Tips/Complaints
Geographic
Multimedia
Chemical Risk
A
# Facilities
Identified on
Master List
6
3
-
3
3
2
2
2


1



B
Targeting Weight
Assigned
40%
20%

10%
20%
0%
0%
0%


10%



C
» Facilities to be
Selected
4
2

1
2





1



Instructions:
L The number of planned inspections is based on Regional resources, decisions, and
commitments.
2. Column A can be completed from the targeting printouts and working files used to
identify potential facilities to be inspected.
3. Column B must be completed based on Regional priorities and concerns. It should
include the weight (percentage) assigned to each targeting criterion.
4. Column C is completed by multiplying the weight (percentage) in Column B by the
number of planned inspections found at the top of the page. Fractions should be
rounded.
5. Column C is for the number of inspections to be selected randomly from each targeting
criterion.
November 1992
2-34
TSCA {ft 5/8 Inspection Guidance

-------
Chapter Two Targeting TSCA Sections 5 and 8 Inspections
assessment of each facility based on different areas of concern that may apply. It is not intended to serve
as a formal assessment of facilities' actions or violation potential. As in the previous worksheet, the first
column includes all the targeting criteria discussed in Section 2.3. Using the master list, the facilities
identified as potential targets are listed in the second column. Using information from printouts and files,
the inspector can complete the shaded portion of the worksheet, based on which concerns are found, by
checking each box mat applies for a given facility. Although not comprehensive, the worksheet includes
several categories of risk or concern that may indicate a higher priority for inspection. In the risk
category, spaces are provided as follows:

* QSQSKBhjfi. Is the facility located in a geographic area of special concern?

• Toxicitv/exposure/volume. Does the facility manufacture a chemical with a high degree of toxicity,
potential for exposure, or large volume?
• Multi-media. Are there multi-media impacts or concerns about the facility from other program
offices?

The area of concern about "coverage" is designed to address previous inspection activities or multiple
submissions from a facility. Spaces are provided for recording the following issues:
• Never inspected. Was an inspection at the facility never conducted or conducted more than 2 years
ago?
• Multiple submissions. Did the facility submit information under several provisions of TSCA, or
was it identified under several targeting criteria?
• Previous target. Was the facility identified as a target in past years but not inspected because of
resource constraints?
Space is also provided to record whether the facility was the subject of a tip or complaint from
Headquarters or another Region. Finally, space is left for other issues identified by the Region, such as
past violations, pending actions, etc. These could be identified from the IDEA system, as previously
discussed.

The final column reflects the "score" assigned to the facility based on adding the checks from each of the
areas of concern in the shaded section. The intent is that facilities with higher "scores" would be selected
for inspection ahead of those with lower scores, until the Regional goal for inspections is achieved. Of
course, more complex scoring systems could be applied to produce a finer level of assessment.

TSCA *9 5/8 Inspection Guidance 2-35 November 1992

-------
Targeting TSCA Sections 5 and 8 Inspections
                              Chapter Two
                                  FIGURE 2-4




               SELECTING FACILITIES WITHIN PROGRAM AREAS



                              Example Worksheet 2
Tuvetbig
Criterioa
Non-
Sub mitten
5
-------
Chapter Two
     Targeting TSCA Sections 5 and 8 Inspections
                                  FIGURE 2-5



                           TARGETING WORKSHEET 2



                              Example Worksheet 2
Targeting
Criterion
Non-
Submiaen
5(e)/(0
SNUR
PMN
Withdrawn
BoniFide
IUR
CAR and
PAIR
Other
FadtincB
1) ABC Inc.
2) XXX Chemicili
3) loe'i Import*
4) Sim'i Import!
5) Mom'i Chemical*
6) OAC Inc.
1) Bin Chemical
2) DEF Co.
3) CHI Imperil
DN/A
2)
3)
1) Shady Co.
2) XYZ Inc.
3) Many Product!
DXMPona
2) Shady Co.
3)
DIKLInc.
2)MNOInc.
3)
1) XYZ Inc.
2)KEMInc.
3)
DPLASTInc.
2)
3)
Ride Concerns
Geog.



/
/







/











/


Toi/Exp/
Volume






/





/
/
S






/
/




Mutt.
Media




/



















/


CoTerage Concerns
MnallB-
Wcfer
Imp.
/
/
S
/
/
/





















MnlnV
Submit.






/





/
/
/

See
above




See
above





l»-,n «.,-,-
rrenous
Target
-






/



















Reg/HQ
Tip




/

S











J





/


Other
Issues



























Total
•Score'
1
1
1
2
4
1
3
1
0



3
2
2
0
N/A

1
0

N/A
1

3


Instructions:
1. Complete the first column using nones or code numbers of facilities from targeting printouts and
working files.
2. For each facility (potential target), renew available information and check all applicable "concerns'
listed in the shaded columns, or develop a score for each concern.
3. Total the checks (or scores) in the final column.
4. Choose high scoring facilities in each group for inspection until Regional goals/resources are met.
TSCA SS 5/8 Inspection Guidance
2-37
November 1992
-------
Targeting TSCA Sections 5 and 8 Inspections	Chapter Two

A partially completed model of Worksheet 2 is provided for review. The framework in Worksheet 2 can
be applied independently or in conjunction with the framework developed in Worksheet 1 (which provides
the number to pick in each category). Combinations of approaches can be used also.

After individual facilities are selected, the pre-inspection activities in the next chapter may commence.
Also, secondary facility targets may be selected, based on proximity or other criteria.
November 1992                              2-38            TSCA §§ 5/8 Inspection Guidance
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                                                   Pre-Inspeetion Activities:
Chapter Three	Preparation and Planning
Chapter Three
Pre-Inspection Activities:
Preparation and Planning
                                                                 Page


3.0 PRE-INSPECTION ACTIVITIES: PREPARATION AND PLANNING	3-1

3.1 INTRODUCTION	  3-1

   3.1.1 TARGET SHEET	  3-2

3.2 REVIEWING EPA RECORDS	  3-5

   3.2.1 PURPOSE	  3-5
   3.2.2 TYPES OF INFORMATION TO REVIEW	 3-6
   3.2.3 INFORMATION SOURCES  	 3-9

       3.2.3.1 EPA FILES AND DATABASES	 3-9
       3.2.3.2 EPA INFORMATION MANAGEMENT DIVISION DATABASES	3-10
       3.2.3.3 COMMERCIAL DATABASES  	 3-13

   3.2.4 INFORMATION REQUESTS FOR EPA HEADQUARTERS	 3-13
   3.2.5 CONFIDENTIAL BUSINESS INFORMATION CONSIDERATIONS	 3-15

3.3 PROVIDING ADVANCE NOTIFICATION  	 3-17

   3.3.1 IDENTIFICATION OF CONTACT PERSON TO NOTIFY	 3-18
   3.3.2 ITEMS ADDRESSED IN ADVANCE NOTIFICATION	 3-19
   3.3.3 FOLLOWUP LETTER	 3-25

3.4 A WRITTEN INSPECTION PLAN	 3-25
3.5 GATHERING INSPECTION DOCUMENTS AND EQUIPMENT	 3-30

   3.5.1 TYPES OF DOCUMENTS	 3-30
   3.5.2 INSPECTION EQUIPMENT	 3-32
TSCA §8 5/8 Inspection Guidance         3-i                      November 1992
-------
Pre-Inspection Activities:
Preparation and Planning	Chapter Three

                             LIST OF FIGURES

                                                                     Page
FIGURE 3-1  SAMPLE TARGET SHEET	  3-3
FIGURE 3-2  FACTS SAMPLE D&B DISPLAY	 3-11
FIGURE 3-3  SAMPLE D&B REPORT	 3-14
FIGURE 3-4  SAMPLE TSCA INVENTORY SEARCH FORM	 3-16
FIGURE 3-5  SAMPLE LETTER OF NOTIFICATION	 3-26
FIGURE 3-5  SAMPLE LETTER OF NOTIFICATION (Continued)	 3-27
FIGURE 3-6  SAMPLE TRACKING SHEET			 3-31
                             LIST OF TABLES

TABLE 3-1   TYPES OF EQUIPMENT	  3-34
November 1992                        3-ii          TSCA 55 5/8 Inspection Guidance
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                                                                       Pre-lnspection Activities:
Chapter Three	Preparation and Planning
           3.0 PRE-INSPECTION ACTTVmES:  PREPARATION AND PLANNING
3.1  INTRODUCTION
This chapter contains guidance on conducting pre-inspection activities pertaining to the Toxic Substances
Control Act (TSCA).  A good inspection begins with planning, which should commence well before the
inspector visits the subject facility.  Planning is the means by which the inspector identifies  all the
required activities to be completed during the inspection, from obtaining records before the inspection
through writing reports and following up.

Planning includes conducting a thorough review, prior to the inspection, of the U.S. Environmental
Protection Agency (EPA) records and data pertaining to the facility to be inspected (including data that
may be obtained from the subject facility itself). This saves tune in the long run because familiarity with
the operations, history, and compliance status of the subject facility decreases the need for covering these
areas during the limited time typically spent onsite.  In addition, planning promotes a better relationship
with the regulated community because the EPA inspector should be better able to  answer questions
concerning the application of TSCA requirements to a particular facility.  It also enhances the facility's
confidence in the  EPA inspector and aids in establishing good relationships with facility representatives.

Another important benefit of planning  is to enhance the inspector's ability to identify and document
potential violations and thus provide more  time to collect necessary data to assist Case Development
Officers (CDOs)  in their subsequent compliance and enforcement activities.  Ultimately,  planning an
inspection may actually take more time than the inspection itself but will result in a more efficient and
productive inspection overall.

The  objectives of inspection planning are to:

     •   Understand the objectives of the inspection
     •   Understand TSCA and applicable regulations
     •   Be familiar with the compliance history and physical site layout of the particular facility to be
        inspected
     •   Be well-versed in the policies and procedures governing TSCA inspections
TSCA 55 5/8 Inspection Guidance             3-1                                November 1992
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 Pre-Inspection Activities:
 Preparation and Planning	Chapter Three
     •  Have the proper equipment and material for conducting the inspection ready to take to the
        inspection site (see Section 3.5.2)
     •  Be prepared to collect and record documents and samples taken from the facility
     •  Be familiar with the safety plan for protection from potential hazards on the facility site.

 Once a facility has been selected for  inspection (discussed in detail in Chapter 2) proper planning should
 ensure the following:

     •  A properly focused inspection
     •  A systematic framework for comparing a facility's operating practices against applicable TSCA
        regulations
     •  Use of the most efficient and effective approach for conducting the inspection, considering the
        available personnel and funding
     •  Clearly established task assignments in the field when more than one inspector will be onsite.

This  chapter  describes the planning process that should take place  prior to  any routine (e.g.,
nonemergency) TSCA inspection.  (In an emergency situation, little or no time is available for planning.
In such instances, the inspector should consult with her/his supervisor and/or the Region Counsel.) The
basic elements of inspection planning are: reviewing EPA and other records and data concerning the
subject facility (Section 3.2); providing advance notification of the inspection to the facility (Section 3.3);
preparing a written inspection plan to be followed  during the actual  inspection (Section 3.4); and
gathering inspection documents and equipment (Section 3.5).

3.1.1  TARGET SHEET
The target sheet is a one-page summary of EPA information on a particular Premanufacture Notification
(PMN) or PMN exemption.  If applicable, the inspector should use the target sheet to organize and
summarize the available information on the PMN or PMN exemption. A sample target sheet is shown
in Figure 3-1.  Generally, one chemical substance is described on each target sheet.  In some cases,
however, a group of related chemicals can be included on the same sheet.  There may  be more than one
target sheet for a given facility to be inspected if the inspection is to include an investigation into more
than one PMN or PMN exemption.  A target sheet should be prepared if a chemical substance
manufactured by the subject facility is subject to a Significant New Use Rule (SNUR).
November 1992                               3-2             TSCA 55 5/8 Inspection Guidance
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                                                                Pre-inspection Activities:
Chapter Three                                     	     Preparation and Planning
                                      FIGURE 3-1
                               SAMPLE TARGET SHEET
      Place all CBI information in brackets.
      Region(s)
TME#
PMN#
      Parent Company:
      Address:

      Technical Contact:                        Phone:
      Industrial Site(s):
      Chemical Name:
      Generic:
      Specific:
      Trade:
      Use:
      Restrictions (if TMEs)/Special Concerns:
      Supplementary Information:
      Notice Manager:
      Indicates company location which submitted PMN or applied for PMN exemption.
TSCA 55 5/8 Inspection Guidance            3-3                             November 1992
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Pre-Inspection Activities:
Preparation and Planning	Chapter Three

The target sheet should include the following information:
        PMN or PMN exemption number.

        Disposition of the PMN or PMN exemption and the relevant date.

             The reason for the inspection is stated on the disposition line of the form.  For example,
             PMN is withdrawn, suspended, or denied; Test Marketing Exemption (TME) is denied or
             granted with  restrictions; Low Volume Exemption (LVE)  is denied or granted with
             restrictions; facility to be inspected is  the subject of a Section 5(e)/5(f) order, rule, or
             injunction; or chemicals manufactured by the facility are candidates for a SNUR.

             To date, facilities have not been targeted for inspection solely on the basis of chemicals
             being SNUR  candidates.  However, if a  facility is targeted for inspection for another
             reason  (e.g, PMN withdrawn), the inspector should examine records kept by the facility
             on chemicals subject to SNURs to determine if the company is manufacturing the subject
             chemicals in the manner described in the PMN or Section S(e)/S(f) order.  Generally, a
             chemical substance becomes a SNUR candidate if EPA believes that a new use, a different
             manufacturing process,  or increased  production will  increase  worker  exposure or
             environmental release to the extent that there will be concern. Therefore, EPA wants to
             be informed if the substance is being  manufactured in volumes much greater than that
             outlined in the PMN or PMN exemption.

        Information on the parent company,  including name, address, technical  contact and telephone
        number, and  the industrial site(s).

             The parent company and the industrial site(s) can be found on the facility's PMN or PMN
             exemption submittal.  If the facility is small, there will generally be only  one business
             address.  Sometimes, the facility  specifically identifies one manufacturing plant at which
             they will make a chemical substance (or substances); at other times, the facility will list
             several possible manufacturing sites.

             The technical  contact is the facility representative who will be contacted concerning the
             inspection process and the appropriate site for the inspection.  The technical contact often
             can help the Region determine the proper location of the inspection,  which is generally
             based on the reason for the inspection. For example, in situations involving TMEs granted
             with restrictions, or Section 5(e) or (f) orders, rules, or injunctions, where manufacturing
             is permitted but limited, the inspection should be conducted at the plant site where the
             manufacturing takes  place.  For cases concerning withdrawn or incomplete PMNs,
             withdrawn  or denied TMEs,  or Section 5(e)  or  5(f) orders where manufacturing  is
             completely  banned, the preferable inspection site may be the site where the commercial
             development  and  marketing files  are located.   This  is because  manufacturing for
             commercial purposes is not  allowed under  any  circumstances,  so  inspecting the
             manufacturing site may only be advisable after a review of these files to ascertain whether
             the prohibited activity is occurring.  In  some cases, it may be appropriate or necessary to
             inspect both facility locations (e.g., facility headquarters where the research or marketing
November 1992                               3-4             TSCA ftft 5/8 Inspection Guidance
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                                                                     Pre-Inspection Activities:
Chapter Three	Preparation and Planning
             files may be located and the manufacturing site).  Section 6.1.2 of this manual describes
             the various sites that the inspector should consider when scheduling the inspection.
     •  Chemical name: generic, specific, and trade.
     •  Use (of the chemical substance).
     •  Restrictions or special concerns [for TMEs, LVEs, Polymer Exemption (PEs), etc.]
     •  Supplementary information, including a listing of information in the package other than the target
        sheet.
     »  Office of Pollution Prevention and Toxics (OPPT) Notice Manager and phone number, which
        can be found in MTTS.  The OPPT Notice Manager  is the EPA Headquarters person most
        knowledgeable about the PMN or PMN exemption at issue.  The Notice Manager should be
        contacted if the inspector has questions about the facility or the chemical substance that is the
        subject of the target sheet.
32 REVIEWING EPA RECORDS
A thorough review  of EPA records for the facility to be inspected is a critical component of pre-
inspection preparation.  This section focuses on the review of EPA written records and databases, which
together will supply the inspector with crucial background information pertaining to the facility to be
inspected.  However, the  inspector  should also supplement record  review activities by interviewing
appropriate EPA personnel who may have additional information or  knowledge of the subject facility.
The appropriate persons to interview will be based on the inspector's need for clarifying issues or data
discovered during the record review process and on the need for additional information. When reviewing
the available information on a facility, the inspector should identify and focus on the information most
relevant to the purpose of the inspection.

Section 3.2 discusses the purpose of pre-inspection records review; types of information to be reviewed;
sources of information; procedures for requesting  information from EPA  Headquarters;  and CBI
considerations for the records review process.

3.2.1   PURPOSE
Proper review of EPA records prior to the inspection of a subject  facility is essential to the overall
success of compliance inspection efforts. By taking this important preparatory step, the inspector can
TSCA 85 5/8 Inspection Guidance             3-5                              November 1992
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 Pre-Inspection Activities:
 Preparation and Planning	Chapter Three
 obtain crucial information on the facility to be inspected, including data on the specific regulatory
 requirements that apply to the facility as well as site-specific background information on compliance
 history and facility operations.  The information obtained from such reviews (and supplemented by
 interviews with knowledgeable EPA personnel) help the inspector to develop the written inspection plan
 (Section 3.4)  and gather inspection documents and equipment (Section 3.5).  In addition,  facility
 representatives may be more responsive to an inspector who has a thorough understanding of the facility
 operations and structure.

 In general, the objectives of the records review include the following:

     •  Become familiar with facility size, operations, physical layout
     •  Learn about facility compliance history
     •  Discover inadequacies and inconsistencies in the  information on the subject facility that the
        inspector may want to clarify during the inspection
     •  Mifiimize inconvenience"&>"fiacairy'personnel by not having^t6=asfc^fi5rbasi(f facilfty^specific
        information that may already be in EPA records and avoid having to spend on site time doing
        so
     •  Clarify technical and legal issues before conducting the inspection
     •  Develop a usefur and comprehensive written inspection plan that focuses on the issues for the
        facility
     •  Make more efficient use of EPA personnel and funding by saving time once at the inspection site.
        TYPES OF INFORMATION TO REVIEW
There are several types of information, described below as separate information categories, mat may be
obtained by reviewing EPA records (i.e., databases and written files). The specific databases that should
be searched to obtain this information and the procedures for requesting the search(es) to be done by EPA
Headquarters are described in Sections 3.2.3 and 3.2.4.

Several examples of the types of information the inspector should search for during the record review
process are described in the following list.  Obtaining all this information may not be possible; however,
November 1992                               3-6            TSCA H 5/8 Inspection Guidance
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                                                                        Pre-Inspection Activities:
Chapter Three	Preparation and Planning

because of its value to the inspection process, the inspector should expend significant efforts to obtain

these and other types of information on the facility.

     •  General facility information.  Some of the general information on a facility that the  inspector
        should look for during the records review process includes:

             Maps and/or aerial photographs the showing location of the facility and its relationship to
             the surrounding area

             Names, titles, and telephone numbers of facility officials and/or representatives

             Organizational structure

             Special facility entry requirements (see Section 4.4.1 on entry of facilities)

             Past and present (and possibly future) operations and production levels

             Safety equipment and health and safety training requirements

             Water, air, and waste treatment and pollution control equipment

             Descriptions of the facility's (and/or the company's or parent company's) recordkeeping
             and filing systems

             Physical  layout of facility

             Size of facility.

        These types of information are particularly useful in assisting the inspector to plan the details of
        the  inspection  and allocate time and resources,  as well as prepare necessary documents and
        equipment.  For example, information on personnel  and organizational structure can help the
        inspector determine who should be  interviewed during the inspection or  at the start of the
        inspection. Data on facility-specific entry requirements may help the inspector determine whether
        it is necessary  to obtain a warrant. Information not available from EPA Headquarters or from
        Region TSCA files may be available from other program offices in the Region.  Water, air, and
        waste permit applications and inspection reports, for example, could have any or all  of this
        information on a facility.
     •  Previous |"5p¥fl'fln and enforcement information. By reviewing EPA inspection records from
        previous inspections conducted at the particular facility, the inspector may obtain the following:

             Compliance history, including reports, followup studies, findings, and remedial action

             Specific details on past or present noncompliance

             Previous enforcement actions

             Pending enforcement actions and compliance schedules.




TSCA 55 5/8 Inspection Guidance             3-7                               November 1992
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Pre-Inspection Activities:
Preparation and manning	Chapter Three

        The  inspector should be especially attentive to  repeated compliance problems and pending
        enforcement actions  and  compliance schedules.  When these have occurred, verification of
        current compliance in those particular areas  will probably become  the major objective of the
        inspection.

        TSCA  inspectors should also review inspection records, compliance histories, and enforcement
        actions under other programs,  including the water, air, and hazardous waste programs. This
        information can also be critical in planning an inspection and understanding the facility.

     •  Special exemptions from TSCA requirements.  The inspector should ascertain whether EPA has
        granted any PMN exemptions to the particular facility to be inspected (e.g., test marketing
        exemption).  The  inspector must also determine whether any additional requirements may have
        been placed on the facility as a condition of granting the exemption.

     •  Reports prepared by the facility that were obtained during previous inspections.  The inspector
        should  review any reports prepared  by the facility (e.g., self-monitoring reports) that may be
        found in EPA files.  The inspector may review these reports to determine whether there are any
        discrepancies between the self-monitoring records and the EPA records. The inspector may want
        to further investigate any discrepancies, either by requesting clarification from the facility during
        the advance notification (see Section 3.3) or during the inspection.  Therefore,  the inspector
        should  make note of these discrepancies, as well as the proposed method for addressing them,
        in the written inspection plan (see Section 3.4).

     •  Permits and permit applications. The inspector should review any facility operating permits or
        permit applications.  Such documents may provide information on limitations and requirements
        applicable to discharges,  emissions, and operations;  compliance schedules; and monitoring,
        analytical, and reporting requirements.  While the inspector is concerned only with documenting
        potential TSCA violations,  EPA is interested in encouraging  comprehensive environmental
        compliance inspections focusing on compliance with more than one EPA-administered law [e.g.,
        a combined TSCA and Emergency Planning and Community Right to Know (EPCRA) inspection]
        would make it beneficial to  review such permits for indications of potential violations of other
        EPA statutes.

        As noted above,  all  programs, permits, and  applications can also be useful for  providing
        background information.  In addition, monitoring and spill data could alert an inspector to the
        presence of an unexpected chemical of concern, while EPA staff in other programs who  are
        knowledgeable about the facility may be able to provide insight into  facility operations.

     •  Correspondence.  Correspondence between the facility and EPA (or the State) may provide
        important information to the inspector concerning manufacturing, processing, importation, or
        other activities that are regulated under TSCA, as well as information on compliance issues.  In
        addition, EPA's response to correspondence, from the facility can affect the requirements that are
        applicable to the facility. Once again, the inspector should review TSCA-related correspondence
        but may review EPA correspondence related to other program areas, such as air, water, and the
        Resource Conservation and Recovery Act (RCRA).
November 1992                               3-8            TSCA ft$ 5/8 Inspection Guidance
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                                                                      Pre-Inspeetion Activities:
Chapter Three	Preparation and Planning
     •  Laws and regulations.  Although it seems obvious, its importance bears emphasis: the inspector
        should review and identify the TSCA regulations that apply to the  facility to  be inspected.
        Therefore, the inspector should undertake a general review of TSCA regulations prior to the
        inspection, giving special attention to the specific regulatory provisions that apply to the facility.
        For example, as the inspector obtains information on the subject facility suggesting that a TME
        exists, the inspector should review the TME provisions of the regulation.  The inspector also
        should always take copies of the act and the appropriate Code of Federal Regulations to the
        inspection site for reference purposes.
     •  Technical reports.  The inspector should review and,  if necessary, take to the inspection site
        copies  of EPA or  ether publications that provide generic  information on  industrial process
        operations.   As noted elsewhere, the inspector's knowledge of the processes and associated
        control equipment at a facility can be instrumental in ensuring the success of an inspection.  A
        list of technical references is provided in Appendix 3.
The inspector must keep in mind when reviewing documents that some of the information may  be
misleading or nonapplicable.  For example, PMNs are generally submitted by corporate headquarters,
but chemicals are manufactured at a different site (i.e., production site). Thus, the corporate headquarters
site may not be the appropriate site to inspect.

3.2.3   INFORMATION SOURCES
The potential sources of information pertaining to a facility to be inspected will be the same from
inspection  to inspection (i.e.,  EPA databases  and written EPA files).  Actual sources of useful
information, on the other hand, will vary from site to site. This makes the inspector's search of EPA
files for appropriate data, both hardcopy as well as information contained in EPA databases, of particular
importance.  The database search(es) often serve as the major source of TSCA-specific information for
an inspector.  In some cases, however,  other sources (e.g., other program offices, files,  and staff) can
be of equal or greater importance and  nearly always can provide valuable supplemental information.
Major databases are described below, as well as the types of data that may be found in each database.

3 J J.I  EPA FILES AND DATABASES
The inspector should search the Regional files for any information relating to the facility to be inspected.
Some Regions may have a filing system  or database from which the inspector can get information on the
subject facility obtained through compliance monitoring activities of other Regional programs  [e.g.,
National Pollutant Discharge Elimination System (NPDES) permitting, RCRA]. In addition, the Federal
TSCA SS 5/8 Inspection Guidance            3-9                               November 1992
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Pre-Inspection Activities:
Preparation and Planning	Chapter Three

Insecticide and Fungicide and Rodenticide Act (FEFRA) and TSCA Tracking System (FITS) should be

searched to determine if the company has been inspected previously.


The inspector should also check other EPA databases for information on the facility to be inspected. The

following list highlights available EPA databases that can contain information relevant to the inspection:
       IDEA (Integrated Data for Enforcement Analysis) System.  This is a new database developed by
       the Office of Enforcement to integrate information from various databases maintained by different
       program offices for enforcement targeting, case screening, and multi-media initiatives. A User's
       Guide to the IDEA System, dated August 2, 1991, provides instructions on how to access the
       system through the EPA National Computer Center IBM mainframe.

       FACTS (Facility and Company Tracking System). This database provides detailed information
       on names,  addresses, employment, sales,  and Standard Industrial Classification (SIC) codes.
       Facilities with SIC Codes 28xx and 2911 or that are within a particular geographic area can be
       specified.  The database is available through on-line connection to the EPA  National Computer
       Center. A sample FACTS display is shown in Figure 3-2.

       FINDS (Facility Index System). This database is designed to track facilities subject to various
       Federal environmental laws, including the Resource Conservation and Recovery Act (RCRA),
       the National Pollutant Discharge Elimination System (NPDES), and Clean Air Act (CAA). The
       purpose of this database is to cross-check for cross-media analysis. It is available through on-line
       access to the EPA National Computer Center.

       TRIS (Toxic Release Inventory System). This database contains information on facilities subject
       to Emergency Planning and Community. Right-to-Know Act (EPCRA), Section 313 reporting.
       Facilities subject to reporting meet the following criteria: (1) they manufactured, imported, or
       processed more than 25,000 pounds of any of the listed chemical substances for required Toxic
       Release Inventory (TRI) reporting or they used in any other way 10,000 pounds or more of a
       TRI chemical, (2) they conducted general manufacturing activities (classified within SIC Codes
       20-39, and (3) they employed the equivalent of 10 or more full-time employees.  The TRIS
       database contains information on the facility, identification of the toxic chemical, the amount of
       chemical released, and the media to which it was  released.  Information on accessing  this
       database can be obtained from the EPCRA Section 313 Regional contact or by contacting TRI
       User Support at 202-260-9419.
       EPA INFORMATION MANAGEMENT DIVISION DATABASES

The following list contains a summary of the Confidential Business Information (CBI) computer databases

with TSCA information. The Information Management Division (IMD) maintains these databases. As

part of inspection targeting, OCM will request summaries of selected information from these databases
which will then be supplied to the Regions (discussed in Section 2.4). EPA Regions will have the ability
November 1992                              3-10            TSCA 55 5/8 Inspection Guidance
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 Chapter Three
                                           Pn-Inspection Activities:
                                          Preparation and Manning
                                     FIGURE 3-2

                            FACTS SAMPLE D&B DISPLAY
     NATP
     FACTS
     FAQD04P3
U.S. ENVIRONMENTAL PROTECTION AGENCY
FACILITY AND COMPANY TRACKING SYSTEM
      DUN & BRADSTREET DISPLAY
    FACILITY NAME:
    SECOND NAME:
    FACILITY ADDRESS:
    NAILING ADDRESS:
    COUNTY NAME:
    PARENT/SUBS:
    PARENT/HQ COMP:
    ULTIMATE  COMP:
    LINE OF BZNESS:
    SIC CODES:
    CEO NAME/TITLE:
    EMPLOYEES HERE:
    TOTAL SALES:
 ICI AMERICAS INC
 STUART PHARMACEUTICALS DIV
 NEW MRPHY RD/CONCORD PIKE
 WILMINGTON            DE  19897
DUNS-NO:

PHONE:
 06/17/92
 05:52:47
 FAQD04M3

   054718580

302-886-3000
 NEW CASTLE                          MSA:
 P/S NO OF SUBS:  3    HQ/BR:     H   NO OF BR:
 ICI AMERICNA HOLDINGS
 ICI AMERICNA HOLDINGS
 MFC PESTICIDES       YEAR STARTED:   1971
 2879    2861    2834    3672
 B LOCHTENBERG/CHAIRMAN OF THE BOARD
 3000 ACTUAL               TOTAL BMP:   12000 ACTUAL
 3264037000 ACTUAL
                   9160
                   110
              057146011
              057146011
     MANUFACTURING:   N
                LIST SUBS/BRANCHES  (Y):
                             LIST PARENT/HQ  (Y):
       PF1/13 - HELP            PF3/15 - PREV              PF4/16
    BBC for ATtention,  Hone to switch•   |      Capture Off
                                             • MAIN
                                             g  Application
TSCA fifi 5/8 Inspection Guidance
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             November 1992
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Pn-Inspection Activities:
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to get information directly from some of the IMD databases (e.g., CICIS, CCID, and CUS) as they get

on-line access.
       Chemical  Directory (ChemDl  Using Molecular Access  System (MACCS) software, the
       Confidential Data Branch maintaias structural data on Section 5 Inventory chemicals.  This
       system is linked to the various CBI systems.

       Chemicals in Commerce Information System (CICIS).  This 'system is the TSCA Section 5
       Inventory, comprising data on the chemicals being produced when TSCA was enacted and
       reported initially in 1978 and 1979, plus those chemicals added by Notice of Commencement
       after EPA review of PMNs. The CBI version adds those CBI chemicals for which CAS Registry
       Numbers have been assigned.  In addition, the CBI version contains all submitter and production
       data received in the Initial Inventory reporting period, as well as via the PMN process.  The
       CICIS report allows quick accounting for many of a company's chemicals when checking their
       general production inventory.

       Confidential Chemicals Identification (CCIP). This database contains nomenclature and related
       information  for Inventory chemicals reported  in  the beginning  and  added via Notice of
       Commencement, where chemical identity was claimed confidential. Many of the entries are not
       CAS-registered.

       Chemical Update System fCUS).  This system includes data submitted  to EPA under the
       Inventory Update Rule every 4 years. These data relate to organic chemicals on the Inventory,
       excluding polymers, and include producer/importer and production volume data.  This system,
       used with CBI CICIS, provides current information on  chemical production.

       Comprehensive Assessment Information Rule (CAIR1 System. This includes detailed production,
       raw materials, processing, use, environmental fate,  worker exposure, environmental release,
       physical/chemical  properties, and waste generation and handling data  on Section 8(a) listed
       chemicals (see Chapter 7). Companies required to report also submit considerable economic and
       financial data, which are housed in the system.

       Document and Personnel Security System (DAPSSV   This system serves two purposes: it
       catalogues documents submitted to and developed by EPA that contain CBI, and it lists EPA staff
       cleared for access to TSCA CBI and the dates on which their clearances expire.

       Confidential Business Information Tracking System (CBITS).  This local area network based
       personnel security and document tracking system contains data similar to that contained in
       DAPSS and tracks documents received since October IS, 1990.

       PENTA (Section  5).   This system contains only CBI pertaining to  PMNs and  Exemption
       Applications, together with review analyses of the data.  Certain common fields are loaded from
       Management Information Tracking System (MTTS);  most other data are available  only in the
       PENTA.

       MTTS. This system tracks new chemicals and contains non-CBI versions of information from
       PENTA.
November 1992                             3-12           TSCA 55 5/8 Inspection Guidance
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            Level A Preliminary Assessment Information Rule (PAIR) System.  This system contain;
        data collected under Section 8(a) of TSCA on chemicals identified periodically by the Interagency
        Testing Committee (also see Chapter 7).
3.2.3 J COMMERCIAL DATABASES
In addition to reviewing information contained in the above databases for information pertaining to a
particular facility or chemical  manufactured by a facility,  the inspector should search the  Dun &
Bradstreet (D&B) Report or other commercial data systems to obtain additional information, such as the
type of business and the size. (A sample D&B report is shown in Figure 3-3).

This report exists in several versions, including the Site Report.  This report is usually adequate for most
TSCA inspection purposes and is generally current. Therefore, an available printout is a good indication
that the company is in business and that the plant site is active.  The report will include the name and
telephone number of a manager or other senior level official. The inspector may obtain information from
D&B by contacting the Information Services Branch of the National Enforcement Investigations Center
(NEIQ.

3.2.4   INFORMATION REQUESTS FOR EPA HEADQUARTERS'
The inspector will need to request information pertaining to TSCA Sections 5 and 8 (and to a particular
facility's compliance status under these sections) from EPA Headquarters prior to (and possibly after) a
TSCA inspection. The inspector requests such data by submitting a TSCA Enforcement Request (ER)
to OCM.  Regions may request the following types of information, among others, by submitting an ER
toOCM:

    •  TSCA Inventory status
    •  PMN and PMN exemptions
    •  Section 8 reports
    •  Technical assistance and opinions
    •  Company specific information/pre-inspection data.
    1   The procedures described in this section reflect current policy.  However, the policy is being reconsidered
       in light of OPPT reorganization.  Therefore, the inspector should first contact the OCM ER coordinator
       regarding the ER policy.
TSCA $8 5/8 Inspection Guidance            3-13                              November 1992
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                               Chapter Three
                                    FIGURE 3-3

                               SAMPLE D&B REPORT
DUNS: 08-212-4637
DF A of California
One.)
Box 86
Fresno, CA 93707
1855 S Van Ness
Fresno, CA 93721
Date Printed:
Agricultural Laboratory
SIC No. 73 99
Telephone: (209)233-7249
Rating: Branch
Employs 10
Branch Manager. H. Riedle
Amounts may be rounded to nearest figure in prescribed ranges.
Payments
Reported
10/87
06/87
10/86
Paying
Record
(001)
Ppt-Slow
15
Disc
High
Credit
2,500
2,500
50
Now Owes Past
Due
2,500
2,500 1,000
-0- -0-
Selling Last
Terms With
lino.
N30 Imo.
2-3 mo.
This is a branch: headquarters are located at 303 BrokawRoad, Santa Clara, CA.
Headquarters D-U-N-S 07-631-5126. The manager has authority to make purchases of
supplies. Bflls are paid generally from headquarters. This branch operates as the Fresno
district of and laboratory for dried fruit and tree nuts.
Facilities:
Rents 6,000
Location*
sq. ft. in one story brick building, normal condition. - Premises neat.


Industrial section on well traveled street.
11-06 (9AO /158) 052 160
Full Display Complete
November 1992
3-14
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The inspector should note that requests for certified statements or documents involving Sections 4,6, or
12 should be sent to OCM.  Inspectors are advised that multiple requests should not be made. (A sample
ER form for requesting a search of the TSCA Inventory is shown in Figure 3-4.) A policy memo entitled
Guidance for Requesting TSCA Section 5 and 8 Enforcement Requests,   dated March 12,  1992,  is
contained in Appendix 2. This package contains the procedures for submitting requests for information
from IMD as well as sample forms that should be used. All enforcement requests are generally processed
in approximately four weeks.  Therefore, there may be situations where documents that should be
reviewed prior to the inspection cannot be delivered to Regions prior to  the scheduled inspection time.
In such instances, the inspector should ensure that copies of such documents are made available by the
facility for review onsite.  In an emergency situation, the turn-around time can be expedited, but the
Region submitting the request should provide a detailed explanation of the emergency situation.

In addition, the inspector may request IMD to provide a certified statement, certifying any number of
TSCA-related facts.  Examples of such certifications include the following:

    •  A particular chemical was added on a specified date to the TSCA Inventory.
    •  A chemical was submitted for review and reviewed under the premanufacture notification (PMN)
       provisions of TSCA.
    •  A chemical was not submitted for PMN review and was not added to the Inventory.
    •  A chemical has completed EPA's Low Volume Exemption Application review process.
    •  The date of submission of TSCA §8(a) required (e.g., PAIR Form) report.

3.2.5 CONFIDENTIAL BUSINESS INFORMATION CONSIDERATIONS
Section 14 of TSCA and EPA regulations (40 CFR Pan  2) protect CBI from disclosure.  CBI includes
trade secrets (including  process, formulation, or production data), the uncontrolled disclosure of which
could cause damage to  a facility's competitive position.  In general, disclosure of CBI is prohibited;
however, there are certain specific and limited exceptions (see 40 CFR Pan 2).

The inspector should  keep in mind that information obtained from a facility during a TSCA inspection
can, for the most pan, be disclosed in response to a request from the general public, or other requesting
TSCA 55 5/8 Inspection Guidance            3-15                             November 1992
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Pre-Inspection Activities:
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                                                  Chapter Three
                                   FIGURE 3-4

                    SAMPLE TSCA INVENTORY SEARCH FORM
                      SEARCH OF COMPLETE TSCA INVENTORY
                                EPA-REGION
                                           OCM Received
                                           ERNo.
      Priority _

      Inspector
Dote
      Phone Number
      Certified Statement DYES  DNO    CAS No
      SPECIAL NOTE FOR DYES: At a minimum, you must provide a valid chemical name
      (not trade name) and/or chemical structure.

         D Substance is not a Color Index name

         D Substance is not hydrate
               •^•^•^•H
                CHEMICAL NAME
                                                 MOLECULAR FORMULA
                                                INVENTORY REFERENCE
                                                   (Inventory Form No.)
            IMD RESPONSE SECTION
     Search completed on
     Date placed on inventory'
     PMN# (If applicable)
                         DNot on inventory
                         Dlnvalid CAS number
                         DValid CAS number is not equivalent
                             to submitted chemical name
November 1992
                    3-16
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 party, under the Freedom of Information Act (FOIA).  However, if the data have been properly claimed
 as CBI, they may not generally be disclosed under FOIA.

 An inspector must present notice to facility representatives of their right to claim data at the facility as
 CBI (see Section 4.7.4) and such claims are frequently made.  Because the inspector is very likely to
 require  access to CBI before (i.e., while preparing for an inspection), during, and after an inspection,
 the inspector must be knowledgeable of EPA procedures governing access to, handling of, and disclosure
 of  CBI.  The  inspector and others who may  use  the information must  have  TSCA-CBI access
 authorization, since only authorized individuals may have access to CBI.  An inspector may need access
 to CBI  data that  a  subject facility submitted to EPA or provides  during the inspection as well  as
 information that was collected during a prior inspection.  (See Appendix 4, for information on handling
 CBI under TSCA.)

 A CBI-cleared inspector may obtain access to  CBI documents at EPA by  requesting access to the
 information from the TSCA Document Control Officer (DCO).  The TSCA DCO is responsible for the
 following:

     •   Verifying that the requesting inspector is on the authorized CBI access list
     •   Providing a copy of the CBI document to the inspector
     •   Determining whether the inspector has secure storage approved by EPA, if the CBI is to be kept
        by the inspector for more man a day.

 It is very likely mat most data obtained from EPA Headquarters is CBI. In order to facilitate the transfer
 of CBI information to the Regions for use in  conducting inspections under TSCA, EPA established a
 policy authorizing telephone discussion of CBI information obtained by EPA under Section 5 including
 the provisions on PMNs and TMEs.  Basically, communication by telephone can include CBI when the
 contact is from Region to Region, Region to specified Headquarters offices, Headquarters to Region, or
 Headquarters/Region to subject facility. (See Appendix 4 for specific details on the handling of CBI.)

33 PROVIDING ADVANCE NOTIFICATION
 EPA is not required by law to provide advance notice of inspection. However, an inspector may opt to
provide such notification, based on the circumstances of the particular inspection and facility.  In such
TSCA ftft 5/8 Inspection Guidance            3-17                             November 1992
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instances, a facility may be notified in writing and/or by telephone that an inspection under TSCA will
take place. It is up to the discretion of the inspector and the Regional office to decide whether or not to
provide advance notification.

Because of the highly technical nature of these inspections, the sensitivity of the information involved,
and the need to ensure mat appropriate personnel and records are available for inspection, the company,
in most cases, is notified in advance that an inspection is planned.  (For inspections involving certain
well-documented complaints or  tips, prior notification  to  the  company may  not be desirable.
Headquarters will notify the Region if this is the case.)

The potential advantages and disadvantages associated with providing advance notification are as follows:
     •  Potential advantages
        -   The  facility will have the necessary documents,  records, or personnel accessible to the
           inspector, saving valuable time on site and requiring less time during followup stages of the
           inspection.
        -   The  subject facility  appreciates  being  provided advance  notification so that  its regular
           operations are not interrupted, thereby fostering a cooperative relationship between EPA and
           the regulated industry.
     •  Potential disadvantages
        -   The  inspector may not have the opportunity to  view the subject facility under normal
           operating conditions, because the facility, with advance notification, could tailor its operations
           to fit preconceived  notions of what the inspector may want to see.
        -   At a facility suspected of violating TSCA  requirements),  the company officials  might be
           encouraged to alter or destroy evidence confirming the violations).
3 J.I   IDENTIFICATION OF CONTACT PERSON TO NOTIFY
If the decision is made to provide advance notification, the inspector must determine which individual
at a particular facility is the appropriate one  to arrange the inspection.  This determination can be
difficult.  The technical contact identified on  the target sheet may be the initial contact.  However,
another senior-level person, such as Plant Manager, Regulatory Affairs Manager, Environmental Affairs
Officer, Laboratory Director or other official of equivalent rank, may serve as the contact for arranging
November 1992                              3-18             TSCA 55 5/8 Inspection Guidance
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and coordinating the inspection.  The inspector may want to review the PMN, TME, PAIR submittal,

or other available documents submitted to EPA to obtain names of contact persons. The D&B report can

also be used, which usually provides the name and telephone number of the senior person in charge of

a listed facility.  If the inspector is unable to obtain names through these methods, s/he should call the
company's general number and ask to speak to the person in charge of environmental  or regulatory

affairs, or if there is no such person, possibly the health or safety officer or laboratory director.


3.3.2   ITEMS ADDRESSED IN ADVANCE NOTIFICATION

if advance notification is provided, the inspector should make  note of this  in the inspection report
(discussed in  Chapter 10).  Specific objectives of advance notification include the following:


    •   Scheduling the inspection.

    •   Determining the appropriate site(s) for the inspection,  including identification  of where the
        necessary records, as specified in the inspection plan, are located.  Records the inspector needs
        to review should be described as specifically as possible.

    •   Ensuring that personnel are available to accompany EPA inspectors during the inspection. _

    •   Ensuring that someone onsite will be able to make claims of TSCA CBI.

    •   Encouraging the facility to transfer all records to the plant site before the inspection.


If the facility  representative contacted does not cooperate, the inspector's supervisor and the Compliance

Branch Coordinator at EPA Headquarters should be consulted for instructions on how to  proceed.


When providing advance notification by telephone to the appropriate contact person at the facility (i.e.,

the technical contact or other individual), the inspector should discuss the following items:
    •   Introduction.  The inspector should begin the telephone contact by introducing herself/himself
        as an EPA inspector or other person with the authority to conduct TSCA Section 5  and 8
        inspections.  The inspector should discuss the nature  and purpose of the inspection.   If the
        inspection is routine, as opposed to "for cause" (i.e.,  based on a tip or complaint), this fact
        should be conveyed.  If the inspection is being conducted "for cause," the inspector should obtain
        guidance from her/his supervisor and/or Regional  Counsel as to the nature and amount of
        information that should be conveyed during the initial telephone conversation.
TSCA 55 5/8 Inspection Guidance            3-19                              November 1992
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Pre-Inspection Activities:
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     •  Administrative details of the inspection.  The  inspector should discuss several administrative
        matters pertaining to the inspection.  Specifically, the inspector should establish the following:
        •  The location of and directions to the inspection site

        -  The date and time of the intended inspection

        -  The name and title  of the facility  employee or official who will serve as the designated
           contact person for the inspection, if such person will be different from the one contacted
           during this advance telephone notification

        -  The fact that  the facility should have certain records and other data available for review
           during the inspection  and that certain facility personnel should be available during the
           inspection for interviews

        -  The need  to tour the manufacturing and other operational areas of the facility

        -  The types of safety equipment that may be needed to tour the facility

        -  The company's right to claim TSCA  CBI for any information collected at the facility (see
           Section 4.7.4, for discussion of CBI)

        -  A followup letter that will be sent which includes: the purpose and scope of the inspection,
           the records that the  facility should make available for  review by the inspector during the
           inspection (discussed below), information on the right of the facility to claim data as CBI
           under TSCA,  and the name of an EPA contact.

     •  Specific records to be made available.  The inspector should inquire as to whether the company
        has submitted to EPA any of the following records (in addition to those of which the inspector
        is already aware):

        -  Premanufacture notifications, bona fide inquiries, or any PMN exemption applications

        -  Section 8(a) Level A PAIR or CAIR reports, Section 8(c) allegation records,  Section 8(d)
           reports or lists, or Section 8(e) substantial risk reports (see Chapter 7)

        -  Section 12(b) notifications

        -  Clarifying information that the inspector may want to  discuss based on any discrepancies or
           uncertainties discovered during the review of EPA records on the facility.
In addition, the inspector should establish if any Section 5(e)/5(f) orders, consent decrees, injunctions or

SNURs are in effect and their status (i.e., whether the subject chemicals are in production or not). The

inspector  should also determine whether the facility  has  an active  Section  8(c) file of health and

environmental allegations and whether the facility has Section 8(c) and/or 8(e) policy and procedures on
November 1992                               3-20             TSCA 55 5/8 Inspection Guidance
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                                                                      Pre-Inspection Activities:
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file at the site or elsewhere. The inspector should inquire as to whether the facility has any other TSCA-
related policies, procedures, and/or submittals on file that may be reviewed during the inspection. The
inspector also should-obtain information concerning the status of the facility's current research and
development activities at the she and whether the development of new chemicals is involved.

If the answer is "yes" to any of the above inquiries, or the-inspector already has Information indicating
that the answer is "yes," the inspector should request mat the facility  contact make any or all of the
records and/or reports  detailed below available for examination during the  inspection (even if the
inspector already has some of the copies, since s/he should verify  EPA's records). Since the following
records and other data are so numerous, the inspector may want to simply inform the facility contact of
the general topic headings of the records/data listed below and send the details in the followup letter prior
to the  inspection.  The inspector should request the facility contact to make available the following
records and data, among others, during the inspection:  .

    •   General information on facility
        -  Facility's current annual report.
        -  Facility's organizational chart.
        -  Facility's recordkeeping procedures and policies for keeping production, sales, and inventory
           records/reports.
        -  Facility's  written  policy  on classification of  R&D,  test  marketing,  and commercial
           chemicals/products.
    •   General inventory
        -  A listing of all manufactured or imported  chemicals  produced during the most recent 12
           months, as well as raw materials and isolated intermediates should be requested.  The listing
           should give CAS number, chemical name, and trade name for each chemical.  (This list can
           be requested by the inspector only  to assist in completion of the inspection  in a timely
           manner;  There is no  regulatory  requirement that it be prepared or maintained by the
           company.  The inspector should  indicate to  the facility the reason for the request and advise
           that it is voluntary.)
    •   PMN
        •  Copy of complete PMN submhtal(s), including all attachments. •
        -  EPA's acknowledgment of receipt.
TSCA ft} 5/8 Inspection Guidance            3-21                              November 1992
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 Pre-Inspection Activities:
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        -   Copies of all correspondence relating to PMN(s).

        -   Copies of all bona fide inquiries related to PMNs.

        -   Copies of Notices of Commencement, if submitted.

        -   Import and shipping records.

        -   Invoices and sales records.

        -   Inventory records.

     •  Research and Development (R&D) Exemption

        -   Records of production, notification, and disposition for any R&D exempt batches of the PMN
           substance(s) that were produced or imported.

     •  TME

        -   Copy of TME application(s), a copy of the Federal Register notice (if not already available),
           and  copies  of any correspondence  with EPA  regarding review and/or approval  of the
           application.

        -   All records of production, import, or distribution of the TME chemical.

        -   Copies of any bona fide inquiries related to the subject TME.

        -   Records of production, import, notification, and disposition for any claimed R&D exempt
           batches of the TME substance that were produced or imported.

     •  LVE

        -   Copy of the LVE application.

        -   Copy of the LVE Federal Register notice (if not already available).

        -   Copies of correspondence with EPA  regarding the exemption, including a copy of the bona
           fide inquiry, if applicable.

        -   All production and other records for the LVE material, including records related to customer
           notification.

        -   All batch, customer, sales, and disposition records for any of the LVE chemical produced or
           imported.

        -   Internal corporate correspondence regarding the development and production (or importation)
           of the LVE chemical.
November 1992                              3-22           TSCA 58 5/8 Inspection Guidance
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    •  Instant Film Chemical Exemption (IFCE)

       -  Copy of the IFCE application.

       -  Copy of the IFCE Federal Register notice (if not already available).

       -  Copies of correspondence with the EPA regarding the exemption.

       -  Internal corporate correspondence and memos regarding the development and production or
          importation of the IFCE chemical.

       -  All production, importation, training, and treatment records for the IFCE chemical.

       -  All batch, customer, sales, inventory, and other disposition records for  all of the IFCE
          material.

    •  PE

       -  Copy of the PE application.

       -  Copy of the PE Federal Register notice (if not already available).

       -  Copies of any correspondence with EPA regarding the exemption.

       -  Copies of any internal corporate correspondence regarding the development, production, or
          import of the PE  material.

       -  Information regarding sources and/or raw materials (monomers, catalysts, and linking agents)
          necessary for the  production of the PE substance.

       -  Production and other records required by 40 CFR §723.250(r), including documentation that
          the requirements of 40 CFR §723.250(e)(l)(2) are met.

       -  All batch, sales,  inventory, and other disposition records for any PE material made or
          imported by the company or facility.

    •  Section 8(a) Level A Preliminary Assessment Information Rule (PAIR) reports

       -  Copies.of production, batch, or other records used to calculate the reported values, including
          onsite and:offshe use. If the firm is a suspected nonreporter of a PAIR report for a particular
          chemical, the production  and batch records for  the appropriate  time period should be
          requested to be made available for the inspection.

       -  Copies of typical  timesheets, production schedules, costing records, or other documentation
          used to determine worker exposure.

       -  Copies  of any correspondence  with  EPA  or within  the facility regarding  reporting,
          interpretation, accuracy, or other aspects of the  PAIR submittal.
TSCA {$ 5/8 Inspection Guidance            3-23                              November 1992
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Pre-Inspection Activities:
Preparation and Planning	Chapter Three

     •  Section 8(b) chemical inventory update reporting

        -   Chemical Inventory Reporting forms and exemptions with supporting data for the reporting
           periods in 1986 and 1990 and 4 year intervals thereafter.

     •  Section 8(c) records and reports of significant adverse reactions

        -   Recordkeeping system for allegations.

     •  Section 8(d) health and data reporting rule

        -   Copies of Section 8(d)  submitted studies and/or a list of ongoing unpublished health and
           safety effects studies.

        -   Copies of any internal correspondence or correspondence with the Agency regarding any
           actual or potential Section 8(d) submittals.

        -   Any existing testing data or data files  relating to a TSCA Section 8(d)  listed chemical,
           including monitoring and/or epidemiological study data or reports.

     •  Section 5(e)/5(f) consent order, injunction or rule

        -   Copies of the final Section 5(e)/5(f) order, injunction or rule, and associated PMN(s).

        -   Copies of any  internal memoranda or  external correspondence (particularly with EPA)
           regarding the Section 5(e)/S(f) order, injunction, or rule.

        -   Original records or  copies of all records required to be kept according to  the terms of the
           Section 5(e)/5(f) order, injunction, or rule, particularly with respect to production, training,
           protective equipment testing, and product disposition.

     •  SNUR

        -   Copy of the specific SNUR and associated PMN (if a new chemical).

        -   Copies of any  internal memoranda or  external correspondence (particularly with EPA)
           regarding the SNUR.

        -   Original records or authentic copies of all records required to be kept according to the terms
           of the SNUR, particularly with respect to production, training, protective equipment testing,
           and product disposition.
November 1992                               3-24            TSCA 55 5/8 Inspection Guidance
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                                                                      Pre-lnspeetion Activities:
 Chapter Three	Preparation and Planning
 333   POLLOWUP LETTER
 Once the inspection has been arranged by telephone and the appropriate topics have been discussed, the
 inspector should send a detailed fbllowup letter to the facility contact person.  Basically, the letter will
 confirm  in writing die  items  discussed by phone, including the agreed-upon date and time of the
 inspection, the right of authorized persons at the facility to claim data as CBI, and the specific records
 that should be made available for review.  The letter should stress that EPA reserves the right to review
 all records pertaining to activities subject to TSCA and that the list is not necessarily comprehensive (i.e.,
 that records and data other than those specified in the letter may be inspected and copied).  Figure 3-5
 provides a sample letter.

 This letter should not be designated as CBI, and therefore should not include any CBI information.  A
 copy of the letter should be sent to die appropriate EPA Regional Counsel.

 3.4 A WRITTEN INSPECTION PLAN
 After reviewing EPA records and giving advance notification of die inspection Of die inspector decides
 to provide such advance notification), die next step is to develop a comprehensive, well-organized, written
 inspection plan.  The inspector should ensure mat key aspects of die inspection are not overlooked when
 developing diis plan. Also, die inspector should use die plan to brief facility officials during die opening
 conference on die general approach to die inspection (see Section 4.7.3). However, die inspector should
 not provide facility officials with a copy of diis plan, because die inspector may want to deviate from die
 plan during die course of die inspection.
3.4.1   PURPOSE
The main purpose of die written inspection plan is to serve as a guide or blueprint to die entire inspection
process at die subject facility.  The inspector should keep  in mind mat one of die most important
objectives of die inspection is to collect enough documentation of potential violations of TSCA to assist
die CDO in her/his^efforts to  determine compliance and take appropriate enforcement actions  against
subject facilities.  Therefore, me plan should, among orner dungs, identify which records and areas of
die particular  facility  (e.g., R&D  records and R&D laboratory)  should be inspected. Section 3.4.2
outlines die elements of a basic inspection plan.

Some Regions may have developed  standard inspection checklists to guide die inspector during die
inspection process and also to help save time at die site.  The inspector and his/her supervisor may want
TSCA 8ft 5/8 Inspection Guidance            3-25                              November 1992
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Pre-Inspection Activities:
Preparation and Planning	Chapter Three

                                          FIGURE 3-5

                            SAMPLE LETTER OF NOTIFICATION

     Dear	:

          In confirmation of our telephone conversation on	, EPA plans to conduct
     an inspection at your company's facility located at	
     _, under the authority of Section 11 of the Toxic Substances Control Act (TSCA) 15 U.S.C.
     2610, on	,  19	, at approximately	    .  The purpose of this
     inspection is to determine compliance with the requirements of Sections 5, 8,  12, and 13 of
     TSCA that are applicable to the chemical manufactured, imported, processed, or used at your
     facility.  During the inspection, the inspector may (1) review and (if necessary) copy reports,
     files, data and  correspondence that are either required  to be  maintained by  TSCA or are
     applicable to  the chemicals manufactured, imported, processed, or used; (2) observe  process
     operations; (3) evaluate monitoring practices, equipment, and sites, if appropriate; (4) interview
     personnel; and (5) collect official samples, if necessary.  In  addition, the inspector may take
     photographs of selected subjects.

          Among the specific  areas to be addressed are:

          •   Premanufacturing notices (PMNs) submitted by your facility, or requests for exemption
             from  the PMN review process, including low  volume, test marketing, and polymer
             exemptions.

          •   Research and development activities and procedures in effect at the facility, specifically
             as related to compliance with the recordkeeping requirements of the TSCA research and
             development exemption.

          •   Recordkeeping and reporting  under TSCA Section  8  rules,  including Preliminary
             Assessment Information Rule (PAIR), Comprehensive Assessment Information Rule
             (CAIR), Inventory Update Rule (IUR), and  Sections  8(c), 8(d), and 8(e).

          •   Facility or corporate policies developed to ensure compliance with  Sections 5, 8, 12,
             and 13 of TSCA.

     In order to expedite the above reviews, please have available at the time of the inspection all
     records  and documents relating to any specific submissions that you have made to the Agency,
     including PMNs, requests for exemptions, Section 8 reports, and Section 12(b) notifications.
     Also please have available a list of all chemical substances manufactured, imported, processed,
     or used by your facility during  each  of the past 5 years.   This list will greatly assist in
     completion of the inspection in a timely manner.  This list should include an accepted chemical
     name, Chemical Abstracts Service (CAS) Registry Numbers, and  any synonyms or trade names
November 1992                               3-26            TSCA 55 5/8 Inspection Guidance
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                                                                     Pre-Inspection Activities:
Chapter Three                  	       	Preparation and Planning
                                         FIGURE 3-5

                      SAMPLE LETTER OF NOTIFICATION (Continued)

     for each chemical that is manufactured (including isolated intermediates), imported, or used as
     raw  material  in  manufacturing processes.  For chemicals purchased for other uses, please
     provide as much information as possible.  To expedite the inspection, you are encouraged to
     consolidate at the inspection site all the records specified.  You should note that this list is not
     necessarily comprehensive, and the inspector may want to inspect other records or information
     not included on the list.

          Pursuant to regulations appearing at 40 CFR Part 2, Subpart B and, specifically, Section
     2.306, you are entitled to claim any or all the information provided to EPA or collected by EPA
     during the inspection as confidential business information. Such information can be disclosed
     by EPA only in accordance with the procedures set forth in the regulations (cited above).  Any
     such claim for confidentiality must conform with the requirements set forth in 40 CFR Section
     2.203(b).  If you do not assert a confidentiality claim for information provided to EPA, it may
     be released to the public without further notice.

          If you have any questions, please contact me at  fphone number)  . Thank you  for your
     assistance in this matter.
                                               Sincerely,


                                               (Inspector, TSCA Sections 5 and 8)
     cc:   TSCA Sections 5 and 8 Coordinator (jf different from inspector)
          EPA Regional Counsel, Region _
          Others as appropriate (including facility technical contact if another person is the primary
          contact for this inspection)
TSCA §9 5/8 Inspection Guidance            3-27                              November 1992
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Pre-Inspection Activities:
Preparation and Planning	Chapter Three

to use the checklist in preparing the plan and/or append or adapt any such checklist to the written

inspection plan.


The investment of time required to produce a quality inspection plan can save time for the inspector once

at the inspection site.  Also, the inspector can make better use of facility officials' time if a well-prepared

plan guides the inspection.


3.4.2   ELEMENTS OF THE INSPECTION PLAN

Written inspection plans may vary in length and subject matter, but should include at least the following

components:


     •  Objective of the background data search and review and the inspection

     •  Scope and assessment topics of interest/concern

     •  Anticipated inspection activities  and field techniques

     •  Safety (or contingency) procedures.
The
following guidelines should assist the inspector in developing these components:


•  Objective of inspection and background data. This introductory section should provide a brief
   history of factors relevant to the particular facility (e.g., previous inspection dates and types of
   inspections, whether any potential compliance issues were identified and what they were).  This
   section should also identify the objective or reason for the inspection.  This will vary from
   inspection to inspection (e.g.,  "for cause," random, case development, or followup).  More
   specific objectives may also be  identified in addition to the overall objective.

•  Scope and assessment topics.  The  inspection  plan  should clearly  establish the scope of the
   inspection and the assessment topics. The scope of the inspection is a function of the overall
   objective of the inspection. For example, if the inspection is "for cause," then the scope of the
   inspection should include whatever records, operations, and areas of the facility that will need
   to be inspected to determine compliance  with  the  provisions of TSCA suspected  of being
   violated; if the inspection is comprehensive and  will entail determining compliance with many
   provisions of TSCA (e.g., Sections 5, 8, 12, and 13) then the scope of the inspection should be
   all records and processes relevant to determining such compliance.  Some discussion of the
   boundaries of the inspection should be included (i.e., if the inspection will include a tour of the
   facility, as well as records review and interviews with personnel, or will only focus on a records
   review).
November  1992                               3-28            TSCA §5 5/8 Inspection Guidance
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                                                                        Pre-Inspection Activities:
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        Once the scope has been identified, the inspection plan should designate the assessment topics.
        Assessment topics can be roughly defined as the major regulatory areas to be covered during the
        inspection [e.g.,  TSCA Section S or Section 8(b)].  The assessment topics should be further
        broken down into specific questions to be asked of facility officials concerning the particular
        assessment topic and specific associated tasks.  For example, if the main assessment topic is
        R&D exemption pursuant to Section S, an important question would be how the subject facility
        defines research and development.  In addition, the inspector will want to examine the R&D
        records and interview the R&D Director.  The related tasks would be the review of any written
        research and development documentation.  Detailed  information~on assessing compliance with
        the regulatory requirements of Sections 4,5, 8 and 12/13 are presented in Chapters S, 6, 7,  and
        8 respectively.

    •   Inspection activities.  Once the assessment topics have been established, the inspector must
        determine the  most  appropriate  inspection activity or method of assessing  compliance  and
        gathering evidence of potential violations (e.g., observation, records review, interviews, collect
        samples) for each task.

        Compliance and assessment and evidence collecting techniques can be organized in an inspection
        plan as follows:

        -   Observation.   List what activities,  operations,  and/or equipment will be  observed  (e.g.,
           manufacturing processes and equipment).

        -   Records review.  List facility records that will be reviewed to determine statutory  and
           regulatory compliance, along with the regulatory citation(s) applicable to  each record  that
           must be maintained, as well as a description of the required content of each record.

        -   Conduct of interviews.  List the titles, and names if known, of key personnel with whom
           meetings should be held to determine compliance with specific regulatory provisions (e.g, to
           determine compliance with R&D provisions, interview the R&D Director about standard
           operating procedures for R&D at the facility).

        -   Sample collection.   Develop  a sampling plan  according  to EPA policy and  guidance.
           Sampling inspections also require detailed advance quality assurance and logistical planning.
           Sampling, discussed in Appendix S, is done only in very specific situations.

    •   Safety for contingency) Procedures.  Develop appropriate safety procedures  for the type of
        inspection activity being conducted.  Safety procedures for a TSCA inspection should identify
        the expected hazards and types of exposures to be encountered, and necessary safety equipment,
        and should include an emergency evacuation plan. For example, if the inspection involves taking
        a tour of the facility, safety glasses, shoe covers, and a hard hat may be required. The inspector
        should identify the facility's safety requirements when calling to schedule die inspection.  In the
        case of handling and collecting samples, toxic chemical substances always pose a certain degree
        of  hazard and must be handled accordingly.   The inspector should ensure that the written
        inspection plan contains at least the applicable safety guidelines if samples are to be collected.
        In general, the inspector should try to identify any safety concerns mat may arise  during the
        inspection and plan  accordingly.
TSCA ftft 5/8 Inspection Guidance             3-29                               November 1992
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 Pre-Inspection Activities:
 Preparation and Planning	Chapter Three
 For each of the tasks and its associated inspection activity, the inspection plan should list the activities
 that are the highest priority first, and then list additional activities that may be accomplished depending
 on the availability of time and resources.

 3.5 GATHERING INSPECTION DOCUMENTS AND EQUIPMENT
 In addition to preparing the written inspection plan and reviewing EPA records prior to conducting the
 inspection, the  inspector should also gather and prepare the necessary documents and equipment to be
 used during the inspection.

 To accomplish  this task, a tracking sheet should be filled out through Part A (see Figure 3-6.)  This is
 then returned to the Inspection/Official File.  The tracking sheet should be completed after the inspection.
 The completed tracking sheet can be used for inspection monitoring purposes. (Any additional company
 sites for possible future Sections 5 and 8 inspections should also be recorded on the tracking sheet once
 the subject inspection has been completed.)

3.5.1  TYPES OF DOCUMENTS
 No single list of documents and equipment can be appropriate for all inspections.  The list provided below
 is intended for guidance purposes only.  The inspector's experience in the field and information obtained
during pre-inspection planning should assist in preparing lists tailored to specific inspection sites and
 needs.

Specific needs will be determined by  the requirements of the inspection, the availability of equipment,
conditions at the facility, EPA policies, and whether or not advance notification of an inspection will be
given.   Documents necessary  for  the  inspection should  be prepared in advance of the inspection,
whenever possible. The inspector must have the following documents for any inspection under TSCA.
        Notice of Inspeffipn (discussed in Section 4.2.4V This is required under TSCA Section 11 and
        must be presented upon arrival at the inspection site.
        Inspection Confidentiality Notice (discussed in Sections 4.7.3 and 4.7.4.1).  This document is
        used to inform facility officials of their right to claim inspection data as CBI under TSCA.
November 1992                               3-30            TSCA §5 5/8 Inspection Guidance
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Chapter Three
                                      Pre-Inspection Activities:
                                     Preparation and Planning
                                        FIGURE 3-6

                               SAMPLE TRACKING SHEET

      INSTRUCTIONS:
      1.   Complete Part A
      2.   When the inspection is completed, fill out Put B.
      3.   Use as documentation to help in preparing the inspection
          report.


      PART A
      INSPECTOR:.
      COMPANY:.
      ADDRESS:
                                      PHONE:
         D Headquarters     D Manufacturing   D Processing    D  Importing    D  R&D
      Date of Contact:	
      Date of Letter Mailed:	
      Date(s) of Inspection:	
      Inspection Materials and Equipment Needed:
      Inspection Notebooks:  1   2  3  4  5  6_
      Inspection Form Sets:  1   2  3  4  5  6_
                          D Camera    D TSCA Stamp
                          Q Sampling Equipment
      PARTB

      Tip and Complaints:
      5e/5f:
      TME:
      Bonafides:
      Specific PMN:
      Generic PMN:
      LVE:
      PE:
D Yes
  2  3
  2  3
  2  3
  2  3
  2  3
  2  3
  2  3
D No
8(c):
8(e):
8(a) Level A:
8(b):
8(d):
13:
D No
D No
      Company Submitting Additional Information by:

      Record Forms Used For This Inspection:
      	Inspection Notebook
      	TSCA Inspection
             Confidentiality Notice
      	Notice of Inspection
                        . Receipt for Samples and
                        Documents
                        Declaration of CBI
TSCA 55 5/8 Inspection Guidance
             3-31
                                     November 1992
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 Pre-Inspection Activities:
 Preparation and Planning	Chapter Three

     •  Declaration of Confidential Business Information (discussed in Sections 4.7.4 and 4.9.2V This
        is the form on which information and/or documents claimed by facility officials as CBI  are
        described.

     •  Receipt for Samples and Documents (discussed in Section 4.9.2).  This document must list all
        samples and documents taken during an inspection by the inspector.
 In addition, the inspector should be certain to take these documents and materials on an inspection:
     •  Copies of TSCA and regulations.  Inspectors should have copies of TSCA and the regulations
        (found in two volumes of the CFR:  40 CFR Parts 700-789 and Parts 790-end) promulgated
        pursuant to the  act available upon request.  Having such data available can help  improve, the
        relationship between EPA  and the  regulated community, which can foster  better facility
        compliance with TSCA.

     •  Chemicals on Reporting Rules (CORR) list (contained in Appendix 7)

     •  EPA outreach  materials.   Inspectors  should  provide  current,  relevant educational, and/or
        guidance information to facility officials upon request or as deemed appropriate by the inspector.
        The inspector may also inform the facility of the information available and how companies can
        obtain such information by calling the EPA TSCA Assistance Information Service (Hotline)  at
        (202) 554-1404. The inspectors should discuss information available through the EPA Pollution
        Prevention Information Clearinghouse (PPIQ and ways companies can obtain such information
        by calling PPIC  Technical Support at (703) 821-4800. Also, the inspector can provide the name
        of the Regional pollution prevention contact  to the company.   A list of current Regional
        pollution prevention contacts is provided in Appendix 6.

     •  Administrative  information.   Travel authorizations and telephone numbers of travel  and
        procurement personnel who may need to be contacted should be taken by the inspector when on
        travel.
3.5.2  INSPECTION EQUIPMENT

The types of equipment that an inspector takes to an inspection site will vary from inspection to
inspection, depending upon the nature and extent of the inspection and the type of the facility to be

inspected. The inspector should use her/his best judgment, based on training and inspection experience

and on knowledge gained preparing for the inspection, in determining what equipment is necessary for

a particular inspection. The equipment should be well-maintained and in good condition at the time of

the inspection.  Therefore, prior to each inspection, the inspector should check the equipment to make
sure that it is in good working condition.
November 1992                              3-32            TSCA §5 5/8 Inspection Guidance
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                                                                    Pn-Inspection Activities:
Chapter Three	Preparation and Planning
Since each inspection is unique, no single list of equipment or forms can be devised that will fit every
inspection situation. The types of equipment most likely to be needed during a TSCA inspection are
summarized in Table 3-1.
TSCA 8ft 5/8 Inspection Guidance            3-33                             November 1992
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 Pre-Inspection Activities:
 Preparation and Planning
                                        Chapter Three
                                TABLE 3-1  TYPES OF EQUIPMENT
General
• Camera
• Film and flash
equipment
• Pocket calculator
• Tape measure
• Clipboard
• Waterproof pens,
pencils, and markers
• Locking briefcase
• "Confidential Business
Information " stamp
• Stomp pad
• Pre-addressed
envelopes (e.g., to
Document Control
Officer)
• Plastic covers
• Plain envelopes
• Polyethylene bags
• Disposable towels or
rags
• Portable typewriter (or
personal computer)
• Portable copying
machine
• Flashlight and batteries
• Pocket knife
• Merck index
















Safety2
• Safety glasses or
goggles
• Face shield
• Earplugs
• Rubber-soled, metal-
toed, non-skid shoes
• Liquid-proof gloves
(disposable, if possible)
• Coveralls, long-sleeved
• Long rubber apron
• Hard hat
• Plastic shoe covers,
disposable
• Respirators and
cartridges
• Self-contained
breathing apparatus



























ijiiicig-dicy
• Substance-specific first
aid information
• Emergency telephone
numbers
• First-aid kit with
eyewash
• Fire extinguisher
• Soap, waterless hand
cleaner, and towels
• Supply of clean water for
washing

































Samptiog*
• Crescent wrench,
bung opener
• Siphoning
equipment
• Weighted bottle
sampler
• Bottom sediment
sampler
• Liquid waste
samplers (e.g.,
glass samplers)
• Auger, trowel, or
core sampler
• Scoop sampler
• Sample.
bottles/containers
(certified clean
bottles with teflon-
lined lids)
• Labeling tags, tape
• Storage and
shipping containers
with lids
• Ice chest
• Container for
contaminated
material
• Hazard labels for
shipping samples
• Ambient air
monitor
• Field document
records
• Department of
Transportation
(DOT) special 12B
cartons
• Vermiculite or
equivalent packing
• Thermometer
• Colorimetric gas
detection tubes
• pH equipment
• Explosimeter
    2In accordance with EPA policy, a TSCA inspector may not do field woik without first completing an approved health and
safety training program.  Personnel who use respiratory protection equipment must also complete specialized training, which
includes training on protective equipment selection criteria. Program-specific safety training has been developed for field personnel
facing particular risks.

    'Detailed information on collecting samples is given in Appendix 5.
November 1992
3-34
TSCA 58 5/8 Inspection Guidance
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 Chapter Four	Inspection Management


 Chapter Four


 Inspection Management

                                                                  Page


 4.0 INSPECTION MANAGEMENT	  4-1

 4.1 INTRODUCTION	  4-1

 4.2 AUTHORITY	  4-1

    4.2.1  INSPECTIONS	  4-t
    4.2.2  SUBPOENAS	  4-2
    4.2.3  CREDENTIALS		  4-2
    4.2.4  WRITTEN NOTICE OF INSPECTION	-.	  4-3

 4.3 PRELIMINARY STEPS FOR CONDUCTING A TSCA INSPECTION	  4-5

 4.4 CONSENTTO ENTER AND INSPECT	  4-6

    4.4.1  ENTRY BY CONSENT	  4-6
    4.4.2  RELUCTANCE TO GIVE CONSENT  	  4-7
    4.4.3  CONDITIONAL CONSENT	  4-8
    4.4.4  WITHDRAWAL OF CONSENT	  4-10
    4.4.5  INSPECTOR JUDGMENT	  4-10

 4.5 DENIAL OF CONSENTTO ENTER AND INSPECT	  4-11
 4.6 ADMINISTRATIVE WARRANTS	  4-12

    4.6.1  PROCEDURES FOR SECURING AND EXECUTING A WARRANT  	  4-15
    4.6.2  SEEKING A PRE-INSPECT1ON WARRANT	  4-18

4.7 THE OPENING CONFERENCE	  4-19

    4.7.1  PURPOSE	  4-19
    4.7.2  PROCEDURES	  4-20
    4.7.3  TSCA CONFIDENTIAL BUSINESS INFORMATION 	  4-23

         4.7.3.1 TSCA INSPECTION CONFIDENTIALITY NOTICE  	  4-23
         4.7.3.2 DECLASSfflCATION OF CBI	  4-25
         4.7.3.3 CONFIDENTIALrTY CLAIMS	  4-25

4.8 INSPECTION PLAN REVISIONS  	  4-25
TSCA SS 5/8 Inspection Guidance          4-i                       November 1992
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 Inspection Management	Chapter Four


                       TABLE OF CONTENTS (Continued)


 4.9 THE CLOSING CONFERENCE	  4-26

    4.9.1 PURPOSE	  4-26
    4.9.2 PROCEDURES	  4-26
    4.9.3 COMPLIANCE OUTREACH	  4-30


                            LIST OF FIGURES
FIGURE 4-1 NOTICE OF INSPECTION	  4-4
FIGURE 4-2 TSCA INSPECTION CONFIDENTIALITY NOTICE	  4-21
FIGURE 4-3 DECLARATION OF CONFIDENTIAL BUSINESS INFORMATION	  4-24
FIGURE 4-4 RECEIPT FOR SAMPLES AND DOCUMENTS	  4-28
                             LIST OF TABLES

TABLE 4-1  LONG-EXISTING EXCEPTIONS TO REQUIREMENT TO OBTAIN A
          WARRANT	  4-14
November 1992                       4-ii         TSCA $9 5/8 Inspection Guidance
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 Chapter Four	_____	Inspection Management


                             4.0 INSPECTION MANAGEMENT


 4.1  INTRODUCTION

 This chapter discusses the required procedures for entering a facility subject to the Toxic Substances
 Control Act (TSCA) to conduct an inspection under the statute.  This chapter also presents the statutory

 requirements,  as  well as the U.S. Environmental Protection Agency (EPA)  policies.  Guidance is
               	                                             V
 provided to the TSCA inspector on the preliminary aspects of a TSCA  inspection, ranging from a

 discussion of the importance of facility owner/operator consent to a listing of procedures for conducting

 the opening and closing conferences.  Procedures for conducting the inspection to assess compliance with
 various sections of TSCA are covered in succeeding chapters.


 4.2  AUTHORITY

 4.2.1  INSPECTIONS

 In order to enter  a facility to conduct a compliance inspection pursuant to TSCA, the inspector must

 ensure that s/he has statutory authority to inspect such a facility. Statutory authority stems from Section
 11 of TSCA, which specifies:


     •  Who may conduct an inspection (".. .the Administrator, and any duly designated representative
         of the Administrator...').

     •  Which facilities may be inspected ("...any establishment, facility, or other premises in which
         chemical substances or mixtures are manufactured, processed, stored, or held before or after
         their distribution in commerce..."). The inspector may also inspect "...any conveyance being
         used to transport chemical substances, mixtures, or such articles in connection with distribution
         in commerce."  (This implies authority to inspect importers' premises where no chemicals are
         stored on site.)


An inspection under TSCA may be conducted only after the inspector has presented the following items
to the owner, operator, or agent in charge:


     •  Appropriate credentials (discussed  in Section 4.2.3)

     •  Written Notice of Inspection (i.e., of the "premises or conveyances" to be inspected) (discussed
         in Section 4.2.4).
TSCA 8f 5/8 Inspection Guidance             4-1                               November 1992
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 Inspection Management	Chapter Four

 In accordance with Section 11 of TSCA, an inspection must be conducted in the following manner:

      •   Commenced and completed with reasonable promptness
      •   Conducted at reasonable times, within reasonable limits, and in a reasonable manner.
 The scope of a TSCA inspection may include inspection of "...records, files, papers, processes, controls,
 and facilities...."   However, Section 11 of TSCA prohibits, unless described with reasonable specificity
 in the required written Notice of Inspection, the inspection of the following data:
      •   Financial data
      •   Sales data (other than shipment data)
      •   Pricing data
      •   Personnel data
      •   Research data (other than data required under TSCA or a rule promulgated under TSCA).

4.2.2  SUBPOENAS
Section 11 of TSCA grants subpoena authority to EPA. The EPA Administrator may "...require the
attendance and  testimony of witnesses and the production of reports, papers, documents, answers to
questions, and other information...."  by subpoena.  Regional Counsel may want to examine the rules
of the court for that jurisdiction to determine whether EPA  is responsible for the transportation costs of
a witness required to testify.

U.S. district courts have the authority to order compliance with such subpoenas. In addition, any failure
to obey a court  order concerning a subpoena is punishable as contempt.

4.2J  CREDENTIALS
Section 11 of TSCA'requires the EPA Administrator or any "...duly designated representative of the
Administrator..." who  conducts an inspection of a facility subject to TSCA to present the owner,
operator, or agent in charge with "appropriate credentials" and with  a written Notice of Inspection
(discussed in Section 4.2.4). The inspection may be made only upon presentation of such credentials.
The credentials are identifying papers that state the holder of the papers (i.e., the inspector) is authorized
to conduct inspections  pursuant to  TSCA.  Therefore, prior to conducting the inspection, and after
November 1992                               4-2            TSCA fifi 5/8 Inspection Guidance
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 Chapter Four	Inspection Management

 introducing herself/himself, the inspector must present the appropriate credentials. The credentials are
 issued by the EPA Administrator or her/his designee.

 Inspectors must present credentials whether or not facility officials request identification.  Appropriate
 credentials indicate that the holder is a lawful representative of the Administrator and is authorized to
 conduct inspections under TSCA. Credentials should be accessible at all times.  Once facility officials
 have viewed the credentials, they may wish to telephone die EPA Regional office for verification of the
 inspector's identification, which is permissible.  However, credentials may not be photocopied. The
 inspector should make a note in her/his field log that credentials were presented.

 4.2.4  WRITTEN NOTICE OF INSPECTION
 As soon as the  inspector has identified herself/himself and presented the required credentials, s/he must
 present to the  owner, operator, or  agent in charge of the subject facility a written notice of  "...the
 premises or conveyances to be inspected."  This Notice of Inspection (see Figure 4-1) informs the owner,
 operator,  or agent  in charge of the reason for an inspection under Section  11 of TSCA  (i.e., for
 inspecting a facility or conveyance to determine compliance with TSCA, or for inspecting financial, sales,
 or other normally excluded data) and contains the inspector's address and signature.  Although the time
 of the intended inspection is not required, the  scheduled time (and date) of the inspection should be
 included  in the  Notice of Inspection to establish that the inspection was requested at  a reasonable time.
 as required by Section 11  of TSCA.

The  inspector presents the Notice of Inspection after arrival at  the subject facility.  TSCA does not
require the inspector to provide advance notification of the inspection to the facility, but some inspectors
may  choose to provide such notice (discussed in detail in Chapter 3). A separate inspection notice must
be presented for each inspection, but a separate notice  is opj required for each  entry made during the
period covered  by the inspection (e.g., for each separate day of a multi-day inspection).

Data that are ordinarily exempt from an inspection under TSCA may be inspected if they are specifically
listed in the Notice of Inspection.  Facility officials should also  be informed verbally of the intent to
inspect such data, which may include financial, sales, pricing, personnel, and research data. Since these
five categories of exempt data sometimes appear on documents mat the inspector routinely examines, such
as import invoices, the  inspector may  choose to check the  boxes on the  NOI that delineate these
categories of data.  The  inspector should acknowledge that financial, sales, pricing, personnel, and

TSCA 85 5/8 Inspection Guidance             4-3                                November 1992
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 Inspection Management
                                               Chapter Four
                                        FIGURE 4-1
                                 NOTICE OF INSPECTION
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November 1992
           4-4
 TSCA §9 5/8 Inspection Guidance
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 Chapter Four	Inspection Management


 research data might appear on documents that s/he inspects for non-exempt reasons.


 Research data should not be treated like sales and pricing information.  If a facility claims an R&D

 exemption, the inspector should ascertain whether the facility is eligible for the exemption by requesting

 all records that the facility is required to keep according to 40 CFR §720.78. If the facility cannot supply
 the inspector with the required records, the facility may have violated Section 5 of TSCA. Therefore,
 the inspector should demonstrate her/his interest in looking at the R&D data by checking the appropriate

 box on the NOI.


 The inspector should make a note in the inspection notebook that the Notice of Inspection was presented
 and should keep a copy of the notice for the records.



 4 J PRELIMINARY STEPS FOR CONDUCTING A TSCA INSPECTION

 The following procedures should be used by the TSCA inspector to ensure compliance with statutory

 requirements and EPA policy covering TSCA inspections:
      •   In order to comply with the statutory requirement that the inspection of a facility subject to
         TSCA be conducted at a reasonable time, the inspector should inspect the facility only during
         normal working .hours, unless mitigating circumstances, such as an emergency, require that an
         inspection be conducted during non-business hours.

      •   The inspector should arrive at die facility at the tune designated (if it has been included) in the
         Notice of Inspection.  As previously discussed, TSCA does not require advance notice of
         inspection or that the written Notice of Inspection include the time of the inspection, but the
         inspector may want to include the time on the Notice of Inspection as documentation.

      •   The inspector should enter the facility through the main entrance.   If the inspector sent an
         advance  letter (or notice) of inspection to the facility, and in response the facility designated
         a different entrance, the inspector should use the designated entrance.

      •   Upon arrival at the facility, the inspector should present his/her credentials to die guard, if the
         facility has one.  TSCA requires only mat credentials be presented to "owner, operator, or
         agent  in charge," but the inspector  may present them to others as a courtesy.  Inspector
         credentials should be kept accessible throughout die inspection. EPA policy does not allow for
         credentials to be photocopied.  Business cards do not constitute credentials but may be used for
         introductory purposes as appropriate.

      •   The inspector should ask me guard (or die secretary or receptionist, if there is no guard) to see
         the facility owner, operator, or agent in  charge.
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 Inspection Management                        	                        Chapter Four
      •   The inspector may sign a visitor's log or register if requested to do so. However, the inspector
          may_0fit sign any such sheet or other document if it contains restrictive language limiting the
          scope of the inspection, the manner in which the inspection may be conducted, or the manner
          in which  information may be used (e.g., a waiver, release of liability, restriction on the use
          of photographic or other recording devices).  Attempts to restrict the inspection are discussed
          in detail in Section 4.4.3.

      •   Once the owner, operator, or agent in charge has been located, the inspector must present such
          a facility official with proper inspector credentials and the Notice of Inspection.

      •   Although TSCA does not require that a TSCA inspector obtain consent from the facility owner,
          operator,  or agent in charge to enter a facility to conduct an inspection, it is EPA policy that
          the inspector obtain  such consent.  Therefore, if an inspector is denied entry to a facility to
          conduct an  inspection under TSCA, or if the facility owner, operator,  or agent in charge
          attempts to impose conditions upon the entry (i.e., conditional entry), the inspector should take
          action as described in Section 4.4.3.
4.4  CONSENT TO ENTER AND INSPECT

4.4.1  ENTRY BY CONSENT

Although EPA has statutory authority to enter a facility subject to TSCA for the purposes of conducting

an inspection under the statute, and may do so without obtaining consent,  facility officials sometimes

withhold consent or attempt to impose restrictions or conditions upon entry.  However, EPA policy

requires the inspector to obtain such consent for the inspection.  Therefore, the  inspector should not

conduct an inspection until s/he has accomplished one of the following tasks:


     •  Obtained consent prior to conducting the inspection

     •  Or, if unable to obtain consent, followed proper procedures governing what must be done when
         entry to a facility is denied or when conditions or restrictions are imposed by facility officials
         upon authorized TSCA inspectors (discussed in Sections 4.5 and 4.4.3, respectively).


Consent to enter must be given knowingly and freely.  The inspector must  not coerce or lie to facility

officials in order to induce consent.  For example, the inspector must not suggest that failure to permit

entry may result in the imposition of civil or criminal penalties, since the entry may then be considered

non-consensual (i.e., because of the  "threat" of negative consequences).


Express consent is not necessary (i.e., the absence of express denial constitutes consent). Entry remains

voluntary and consensual unless mere is a withdrawal of consent (discussed  in Section 4.4.4).  Consent

must be given by the person in possession (i.e., the possessor) of the premises, or by some other person


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 Chapter Four	Inspection Management

 with authority to give consent at the time of the inspection.  An owner does not always have possession,
 and so may not be authorized to give consent; for example, the owner may have rented the property to
 a tenant who is on the property. If someone hi possession of the facility cannot be located, the inspector
 must make a good faith effort to determine who may otherwise consent to the entry (such as the agent
 in charge).  The inspector should present her/his credentials to that individual and record the name and
 title of that nerson in the insoection  record book.
title of that person in the inspection record book
 The TSCA inspector must obtain express consent to enter the premises for each uncredentialed person
 who intends to accompany the inspector on an inspection. If consent is not given, these persons may not
 enter the premises to be inspected.  No uncredentialed person may have access to confidential business
 information (CBI) unless s/he has  been authorized for CBI  access by the Information Management
 Division (IMD) of the Office of Pollution Prevention and Toxics (OPPT).  IMD circulates monthly a list
 of persons with CBI clearance to the Regional and program Document Control Officers (DCOs).

 In most instances, if the inspector follows proper procedures upon arrival at the facility (i.e., presentation
 of credentials and Notice of Inspection), it will be simple to obtain consent to enter. However, special
 situations may arise, as follows:

      •   Owner/operator reluctance to give consent
      •   Conditional consent
      •   Withdrawal of consent.

These situations and the inspector's  responsibilities  in each situation are discussed below.

4.4.2 RELUCTANCE TO GIVE CONSENT
The receptiveness of facility officials toward an inspector may vary from facility to facility. If consent
to enter a facility is denied outright, the inspector should follow the procedures governing denial of entry
(discussed in Section 4.5). However, in some instances, facility representatives express reluctance rather
than actually refuse to  allow  an  inspector to conduct an inspection.  Often this reluctance is due to a
misunderstanding by facility  representatives of EPA or facility responsibilities under TSCA,  or to
concerns over perceived  inconveniences to the facility operations as a result of the inspection.  Such
concerns are usually resolved through diplomacy and discussion.
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 In such instances, an inspector should tactfully ascertain the reasons for facility officials' reluctance and
 try to resolve the problems.  The inspector should also explain in detail the purpose of the inspection.
 However, it is crucial during any negotiations or discussions that an inspector does  not agree to  any
 restrictions on the scope of an inspection authorized under TSCA.  In addition, die inspector should avoid
 issuing threats of any kind or making inflammatory statements.

 If there  is still difficulty  in obtaining consent after the discussion, the  inspector may  inform facility
 representatives diplomatically that the issuance of a subpoena is one of EPA's options,  under Section 11
 of TSCA for obtaining access to records and other data. In addition, the inspector may suggest to facility
 representatives that they speak with their attorney concerning EPA inspection and subpoena authority.
 If entry is still denied, the inspector should withdraw from the facility and contact her/his supervisor for
 further instructions. Under no circumstances should the inspector attempt to  gain entry or  consent to
 enter by coercive actions or by making statements that suggest mat the facility representatives could be
 fined or otherwise "punished" unless entry is allowed.

 4.4 J  CONDITIONAL CONSENT
 Conditional  consent refers to any attempt by facility officials to restrict the inspection after entry or to
 condition entry upon the adherence to restrictions imposed by the officials.  Some of the more common
 types of conditions that facility officials try to impose on the inspector are the following:

      •  Waivers, indemnity agreements, or releases
      •  Confidentiality or secrecy conditions or agreements
      •  Photographic or tape recording restrictions
      •  Requirements  concerning health and safety gear or training
      •  Duplication of the inspector's notes or credentials for facility review
      •  Denial of access to certain areas of facility.

Generally, any attempt by facility  officials to cause inspectors to deviate from standard  inspection
procedures should be interpreted as an effort to impose conditions on  consent.  EPA policy  is  that
inspectors should never agree to restrictions or conditions on the scope or nature of the inspection.  The
 inspector must never sign any document that could compromise EPA's right to conduct an inspection.
 Any effort by facility officials to impose one or more conditions should be considered denial of consent.
 In such circumstances, the inspector should follow the procedures  governing denials of consent  (see

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discussion in Section 4.5).  However, reasonable requests (such as requesting the inspector to wear a

visitor's badge, hard hat, or safety eyeglasses) should not generally be considered "conditions," and the

inspector may comply with such requests.


Even if the inspector is permitted to enter the facility without being asked to comply with conditions or

restrictions, the inspector should be constantly aware of any attempt by facility representatives after entry

to impose such conditions.  If this should occur, the inspector must regard  this attempt as a denial of

consent and follow appropriate procedures (discussed in Section 4.5).


Some areas in which facility officials may attempt to impose restrictions are  discussed below.
      •   Waivers and other restrictive agreements.  EPA inspectors have the right and the responsibility
         to refuse to sign any agreement or waiver that promises that records or other data obtained
         from the facility will not be released to any third party.  Any attempt by a facility to restrict
         inspection activities by requiring inspectors to sign such restrictive agreements should be
         viewed as a denial of consent to inspect the facility and treated accordingly.  (However, during
         the opening conference, inspectors must advise the facility owner, operator, or agent in charge
         of her/his right to claim such data as CBI and of the procedures for making such claims.)

      •   Restrictions on use of photographic or other recording equipment.  TSCA inspectors may
         document evidence of potential violations  at the  facility  by means of tape recordings,
         photography,  or recording by electronic devices with  a visual taped readout or by other
         methods.  Inspectors have the authority to use these recording devices, which include aerial
         overflights, LIDAR (a type of radar used to detect and measure  distant air  emissions of
         paniculate matter), and other aerial or ground surveillance sense-enhancement devices. Facility
         officials often attempt to restrict the use of any or all  of such devices by EPA inspectors. Any
         attempt by a facility to restrict the use of such devices is considered a denial  of consent and
         appropriate procedures governing such denials should be. followed.  Facility officials should
         be advised that photographs and other information/data gathered by recording equipment may
         be claimed as CBI  (see Section 4.7.4).

      •   Health and safety restrictions. The inspector should ascertain the facility safety and applicable
         Occupational Safety and Health Administration (OSHA) requirements before the inspection, if
         possible.  The inspector should be aware that s/he  is subject to the applicable safety
         requirements of the facility. For example, if  safety boots and glasses are required to walk
         through die manufacturing area, then the inspector must wear them. However, EPA inspectors
         .cannot  be required to participate in the facility's safety training  program as a condition of
         conducting a TSCA inspection. If facility officials make  such a demand, the inspector should
         refuse and should treat the situation as a denial of consent.

      •   Refusal to allow access to certain  areas of facility. If during the course of die inspection access
         is denied or restricted to certain areas of the facility, the inspector should make a notation
         describing such denial or restriction in the field notebook and identify which portion of the
         inspection could not be completed due to the denied or restricted access.  However, despite the


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          access restriction, the inspector should proceed with the remainder of the inspection.  After
          leaving the facility, the inspector should contact her/his supervisor to determine whether  a
          warrant should be obtained to complete the inspection.
 4.4.4  WITHDRAWAL OF CONSENT
 Occasionally, facility officials may initially consent to an inspection and later withdraw the consent during
 the inspection.  Consent to the inspection may be withdrawn at any time .after entry has been made. EPA
 policy concerning withdrawal of consent is to view it as an outright denial of consent. In such cases,
 appropriate procedures should be followed (discussed in Section 4.5). All activities and evidence obtained
 piiof to the  -withdrawal of consent are valid.  Therefore, evidence obtained by the inspector before
 consent was withdrawn would be usable in  any subsequent enforcement actions and should be retained
 by the inspector.  The  inspector  should  not  give  any evidence that has been collected before  the
 withdrawal of consent back to the facility if asked by the facility official.

 4.4.5  INSPECTOR JUDGMENT
 Whenever it  appears mat facility officials,  through statements or actions  (such as1 physically blocking
 entry), are denying or  restricting consent to conduct the inspection authorized by TSCA, the inspector
 must use independent judgment to determine the actual effect the limitation will have on the inspection.

 Sometimes inspectors are able to reach an agreement with facility representatives concerning a condition
 apparently imposed upon the inspection or to find a way around the difficulty.  Inspectors should keep
 in mind that attempts to negotiate with facility officials are based on the  independent judgment of the
 inspectors and, as such,  there are  risks involved (e.g., having a court declare later that consent was
obtained coercively and, therefore, was not consent).  If the inspector is in doubt, s/he should consult
Regional Counsel.

The inspector always has the option of departing  the facility premises and following the procedures for
securing and executing a warrant (discussed in Section 4.6.1). The inspector can choose to discontinue
the inspection at any time after the inspection  has  begun.  The following examples illustrate how
inspectors have actually handled situations mat  might have been considered denials of entry;
     •   Restrictive language in sipi-in book or form.   The inspector should draw a line through
         objectionable language before signing, obtain a photocopy, and make a note in her/his field log
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          about it.  The inspector should also inform the facility officials of the modification s/he made
          and request that a facility official initial it.
      •   Photoyranhs. When facility officials state they do not want photographs taken of the facility,
          the inspector can proceed with the inspection, raising the issue of photographs again only when
          a particular photograph is essential to the inspection. If photography is still not permitted, the
          inspector can follow the procedures for securing and executing a warrant (discussed in Section
          4.6.1).
      •   Safety training.  Inspectors cannot be required to participate in a facility's safety training course
          prior  to entry.  However,  if the facility has a relatively short safety  briefing that  will not
          interfere with the inspector's ability to complete the planned inspection in a timely manner, the
          inspector may want to attend the briefing.  Inspectors are sometimes able to learn valuable
          information about the facility's layout and operations at such orientations.
4.5  DENIAL OF CONSENT TO ENTER AND INSPECT
The first thing that an inspector must keep in mind when facility officials deny consent to conduct a
TSCA inspection is to refrain from making any inflammatory remarks or statements that could jeopardize
subsequent enforcement actions brought against the facility by EPA at a later date.-  For example, the
inspector must not discuss any" potential penalties that are authorized under Section  IS of TSCA for
refusal to permit entry or inspection. If such potential penalties were discussed and consequently facility
officials permitted the inspection to be conducted, officials could later claim such statement was a form
of coercion.  A court could rule at a subsequent proceeding challenging the inspection that some or all
of the evidence collected during the inspection is inadmissable.  For example, if the TSCA NOI fails to
mention that financial, sales, pricing, personnel, or research data will be examined by the inspector, and
s/he does in fact examine these  records  this action might be challenged.   As  another example, the
inspector should not threaten facility officials with the fact that s/he will "get a warrant,"  even though
EPA may later try to secure a warrant to conduct the inspection. This is because a court of law,  which
later may review the search  procedures used  by  EPA, may interpret the statement  as coercive,
invalidating the search.

In practice, refusal by facility officials to permit entry for inspection purposes is not likely to lead to civil
or criminal penalties if it is based upon facility officials' desire to see a warrant before entry is permitted,
even though Section 15 of TSCA  states that it is unlawful for anyone to refuse entry or inspection as
required  by Section 11.
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 In the event that entry is denied, the inspector should write the following information (which will be
 helpful should EPA decide to obtain a warrant at a later date) in her/his field notebook:

      •   Facility name and address
      •   Name, title, and telephone number of person who refused entry
      •   Name, address, and telephone number of the facility's attorney
      •   Date and time of refusal
      •  'Reason for facility's refusal to allow EPA inspector to enter and/or to inspect facility
      •   Description of facility appearance, including number of buildings and general observations,
          such as housekeeping practices
      •   Any reasonable suspicion  that  refusal  stemmed  from  desire  to prevent discovery  of
          regulatory/statutory violations.

 After making the above notations in her/his field notebook, the inspector should immediately leave the
 premises  and contact  her/his supervisor,  who will  confer  with  Regional Counsel  concerning  the
 desirability of obtaining a warrant. The inspector should ensure mat the facility officials have been given
 a copy of the written Notice of Inspection to show that proper procedures were followed.

 Generally, after Regional Counsel is contacted, s/he will discuss the matter of the inspection by telephone
 with facility  officials in order to resolve the issues surrounding the inspection.  If the matter can be
 resolved in this  manner, the inspection should proceed without further delay.  However, if Regional
 Counsel is unable to solve the problem, the inspector should discuss with her/his supervisor the possibility
of obtaining a warrant.

4.6 ADMINISTRATIVE WARRANTS
A  warrant is a judicial authorization for an appropriate official (e.g., EPA inspector, U.S. Marshal, or
other  Federal officer)  to enter  a specifically  described  location and perform  specifically described
functions.  An administrative warrant,  in a TSCA inspection proceeding, is issued by a magistrate at
EPA.  The warrant may be obtained (i) when facility officials have denied entry to an inspector, (ii) when
consent to inspect has been withdrawn during an inspection, or (iii) in advance of inspection.  EPA must
first have a substantive right to enter the premises before the use or the issuance of an administrative


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 warrant is proper. EPA's authority to conduct inspections under Section 11 of TSCA serves as the basis
 for an administrative warrant being issued by a magistrate.

 While almost every EPA statute, including TSCA,  contains  a  provision expressly authorizing the
 Administrator and/or authorized  representatives to enter a subject facility  to  conduct an inspection
 pursuant to the particular law, EPA policy is that where facility officials deny or withdraw consent, a
 warrant must be obtained.  The idea behind this policy is that it is less-jime consuming (and less costly
 in the long run, given the possibility of a legal challenge) to take the precautionary action of obtaining
 a warrant rather than forcibly entering the facility against the wishes of facility representatives.  EPA
 obtains a warrant in order to validate its statutory authority to enter.  The warrant serves as judicial
 confirmation of EPA entry authority.

 The decision of whether to secure a warrant will be made by Regional Counsel in consultation with the
 Compliance Division, Office of Compliance  Monitoring (OCM), and the Toxics Litigation Division,
 Office of Enforcement (OE).  Once the Regions and EPA Headquarters have decided that a warrant
 should be  secured,  precise procedures must be followed for obtaining and executing the warrant
 (discussed  in Section 4.6.1).

 Warrants are applied for and obtained fix. parte:  that is,  without the knowledge of the other side.
 Therefore,  it is  inappropriate to give facility officials advance notification of an inspection that will occur
 under a warrant.  It may  be a criminal offense for anyone to disclose the existence of a warrant prior to
 its execution.

The ability to secure a warrant is important to government officials, especially to inspectors.  In addition
to serving  as judicial confirmation of EPA's statutory right to enter and  inspect a facility, a warrant
 affords substantial legal protection to an inspector from private suits for damages.  A valid warrant gives
 an official absolute immunity from liability for activity conducted in conformity with the warrant.

The inspector should be aware that there are several long-existing exceptions to the requirement to obtain
a warrant.  They are summarized in Table 4-1.
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Inspection Management
                                                       Chapter Four
                                         TABLE 4-1
      LONG-EXISTING EXCEPTIONS TO REQUIREMENT TO OBTAIN A WARRANT
    Exigent
    (Emergency)
    Circumstances
   Includes potentially hazardous circumstances, as well as situations
   in which evidence relating to a suspected-violation may have been
   destroyed
   In an emergency, with insufficient time to obtain a warrant, a
   warrantless inspection is permissible
   Regions must exercise judgement	'
    Plain View
  Legal construction of the courts consisting of three required
  elements:
  1.  Lawful presence:  The inspectors must have lawful and justified
      presence, gained through statutory authority, valid search
      warrant, consent, or "open fields"
  2.  Inadvertent discovery:  Evidence is discovered accidentally.
      The plain view doctrine will not apply if the inspector is
      searching for particular evidence
  3.  Apparently Incriminating Nature: Inspector must have
      reasonable grounds to believe immediately that the item in plain
      view constitutes evidence of a violation of the law
    Open Fields
• Areas where land owner normally has no reasonable expectation of
  privacy
• Valid consent is preferred procedure
• Inspectors may be trespassers, but will not prevent lawful use of
  evidence
• Authority does not extend to residences or areas immediately
  surrounding residences                                 	
November 1992
                    4-14
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 Chapter Four	Inspection Management


 4.6.1  PROCEDURES FOR SECURING AND EXECUTING A WARRANT

 The process of securing and executing the warrant involves numerous steps and people.  The inspector
 plays a critical role in the process of seeking a warrant.  The inspector's knowledge and experience
 pertaining to the circumstances of the particular case are crucial to the drafting of warrant documents.

 Attorneys and inspectors work together to draft all necessary warrant documents.  Inspectors have the

 following responsibilities in the warrant procurement process:
      •   Gather enough information so that a very specific description of the premises to be inspected
          can be obtained.

      •   Specify in detail the items to be searched and/or seized

      •   Describe in as much detail as possible the statutes and/or regulations (and the exact provisions
          of each, if known) that have or may have been violated.
     The steps involved in securing and executing a warrant are as follows:
1.   Contact the Regional Office.   The inspector should discuss with her/his supervisor the facts
     regarding the denial or withdrawal of consent to enter or to conduct the inspection, or the need (if
     any) for a pre-inspection warrant (discussed in Section 4.6.2). The determination will then be made
     whether to seek a warrant.  If the decision is that a warrant should be secured, the Region will
     consult with Headquarters and someone will be designated to contact the U.S. Attorney.

2.   Contact EPA Headquarters Compliance Monitoring Office.  The Regional office should notify OCM
     and OE prior to obtaining a warrant.

3.   Contact the U.S. Attorney. If a decision is made that a warrant should be obtained to conduct an
     inspection of a particular facility, the appropriate Regional official will contact the U.S. Attorney
     of the U.S. District in which the facility is located.  EPA will assist the U.S. Attorney in the
     preparation of the warrant and affidavits.

4.   Apply for the Warrant.  The application for a warrant identifies the statutes and regulations under
     which EPA is seeking the warrant.  The name and location of the premises to be inspected should
     be clearly identified and, if possible, the owner and/or operator of the premises should be named.

     Generally, EPA must draft three documents to obtain a warrant:  an application for a warrant; an
     accompanying affidavit; and the warrant itself.  Each document contains the caption of the U.S.
     District Court of jurisdiction in which the facility is located, the tide of the action,  and the title of
     the particular document.  Occasionally, a Memorandum of Points and Authorities in Support of
     Warrant Application also will be filed.  This legal brief explains why the magistrate should issue
     the warrant.
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 Inspection Management                     	    	    Chapter Four
      The application may be 1 or 2 pages, if the factual background for seeking the warrant is stated in
      the affidavit.  The application is prepared and signed by the U.S. Attorney or by the Assistant U.S.
      Attorney.   The inspector should apply for a warrant as soon  as possible  after the denial  or
      withdrawal of consent to enter and inspect and after discussions with the inspector's supervisor.

5.    Prepare the Affidavits.  The affidavits are critical documents that support a warrant application.
      An affidavit consists of consecutively numbered paragraphs that describe all facts that support the
      issuance of a  warrant.

      The inspector's assistance is essential in the preparation of the affidavit. The inspector must help
      prepare a detailed description of the premises and the items to be inspected and/or seized.  Details
      of die premises include the following: address (lot and range number or longitude and latitude, if
      appropriate);  description of surrounding  area; position on  the block; number of buildings and
      relation of each to one another; description of each building (including color, height, construction
      material); and signs and other unique identifying characteristics.

      The affidavit is signed by  a person with first-hand knowledge of all the facts  (typically,  the
      inspector).  However, "hearsay" or "second-hand" knowledge can be used. In cases where entry
      has been denied, the inspector who was denied entry usually signs the affidavit. An affidavit is a
      sworn statement that must be notarized or sworn to before a magistrate.

6.    Prepare the Warrant for Signature.  A warrant  authorizes an  appropriate official (e.g., U.S.
      Marshal or EPA inspector) to enter a specifically described location and perform specifically
      described functions.  The warrant also  includes a "return of service," an inventory of the items
      seized, and the warrant itself (see Step 9).  Since the inspection is limited by the terms of the
      warrant, it  is important to specify to die greatest extent  possible the areas to be searched (i.e,
      inspected),  identifying any records or other documents to be inspected and/or seized, samples to
      be taken, etc.  While a broad warrant may be permissible in civil administrative inspections,  an
      overly broad or vague warrant will probably not be signed by die magistrate.

      The draft warrant should be prepared in advance for signature by  the magistrate. Once signed, die
      warrant can be executed  (i.e., die search authorized by  the warrant may be conducted) and is
      enforceable.

      The inspector should'accompany the attorney(s) to the office  of  the magistrate, if possible.
      Sometimes questions arise mat the inspector may be able to answer, under oath, that may be added
      to the affidavit in support of the warrant.

7.    Serve me Warrant.  The warrant is served on the owner or the agent in charge of the facility to be
      searched prior to me conduct of the search (i.e., inspection). If there is a likelihood mat entry will
      be refused even with a warrant, or that violence might occur, the  inspector should be accompanied
      by a U.S. Marshal.  In this instance, the  U.S. Marshal is principally charged with executing the
      warrant, and the inspector should abide  by the U.S. Marshal's decisions.

8.    Inspect With the Warrant. Warrants are executed by a physical entry onto the premises.  Local law
      or court rules may also require die handing of a copy of the warrant to someone in possession,
      ownership,  or control of the premises to  be searched or a display of a copy of the warrant in a
      prominent place (this is called "service"). The inspector must Qgxex relinquish the original warrant;
November 1992                               4-16            TSCA Sfi 5/8 Inspection Guidance
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 Chapter Four                                                           Inspection Management
      it must be returned to the magistrate.  The inspector (or U.S. Marshal, as the case may be) must
      certify in the "return of service" portion of the warrant that service (or notice) was accomplished.

      The warrant must be executed without undue delay and within the time period stated in the warrant
      (generally 10 days). Also, the warrant will usually direct that it be executed during daylight hours.

      If the facility representative refuses entry to an inspector who has a warrant, but is not accompanied
      by a U.S. Marshal, the inspector should leave the premises and inform her/his supervisor and the
      Assistant U.S. Attorney about the incident.   Appropriate  action will then be taken,  such as (1)
      sending the inspector back to the facility accompanied by a U.S. Marshal, or (2) seeking a citation
      for contempt.

      The inspector should conduct the  inspection in strict conformity with the warrant. The inspector
      is only authorized to inspect, copy, and/or seize items as authorized by the warrant. The inspector
      must keep a complete list of every item taken or copied, as this list will form the basis of the
      inventory  that must  be returned  with the  warrant to the magistrate  at the conclusion of the
      inspection.  In addition, the inspector must give facility officials receipts for all items copied or
      seized.

      There are several points that inspectors should keep in mind when conducting an inspection with
      a warrant:

      •   If questions arise in the field  about the scope of the warrant, call Regional Counsel.  If the
          inspector discovers items that should have been included in the scope of the warrant, Counsel
          may be  able to convince the  magistrate to amend the warrant by telephone.  If a few items
         taken are later found to be beyond the scope of the warrant, they  will have to be returned.
         This will not normally affect the items taken pursuant  to the warrant. However,  if too many
          items are taken, this could void the entire warrant or result in suppression of all evidence.

      •  Keep in  mind the "plain view" doctrine.  Under this doctrine, the inspector would be able to
         seize items as long as s/he is lawfully present on the premises to see the items in plain view,
         without intentionally searching for them, and has reasonable grounds to believe that the items
         constitute evidence of a violation of the law.  (See Table 4-1 .)

      •  Interview as many individuals as possible to assist in accomplishing inspection objectives.
         There are no restrictions on  asking questions, although there  is no obligation for  facility
         representatives or employees to respond.

      •  If an inspector reasonably fears that destruction of records may occur during the time s/he  is
         attempting to copy records on site, then  seizure and  sequestration (restricting access to the
         records by anyone) would probably be authorized. In such a case, it may be better to risk a
         court ruling that the documents must be returned to the possessor than to suffer their certain
         loss.

      •  Any records to be taken by the inspector can be claimed as CBI and the appropriate procedures
         for declaring CBI should be followed (see Section 4.9.2).
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Inspection Management	Chapter Four


9.    Return the Warrant. After the inspection has been completed, the person who executed die warrant
      (i.e., the U.S. Marshal or whoever performs the inspection) must sign die "return of service" form,
      indicating die name of die person served witii die warrant, die address of die facility searched (i.e.,
      inspected), and die date of execution of die warrant. The person who executed die warrant must
      next submit die return of service form, an inventory of property seized (if any) from die facility,
      and die warrant itself to die U.S. Attorney.  The U.S. Attorney will formally return die executed
      warrant to die issuing magistrate or judge.  The inventory not only allows die court to determine
      whether die inspection was> conducted wirnin me scope of die warrant, but also serves as die official
      record of items seized.

      If anything is physically taken from die premises, such as records or samples, an inventory of such
      items must be submitted to die court, and die inspector must be present to certify that die inventory
      is accurate and complete.

      It is essential mat die magistrate or judge receive die returned executed warrant within die time limit
      stated widiin die warrant.  If die activities are not completed during die allowed time period, die
      warrant can usually be renewed, or a new one is issued based on updated information.

10.   Address Challenges to die Warrant. There is always die possibility that facility representatives will
      challenge a warrant and die evidence obtained as a result of die warrant.  The warrant and  all
      evidence garnered pursuant to it could be invalidated by die courts.  Some of die typical bases for
      challenges to a warrant or evidence obtained pursuant to it are listed below:

      •  Insufficient cause for issuance of me warrant

      •  Insufficient affidavit supporting die warrant

      •  Inaccurate information in me supporting affidavit

      •  Inadequate description of die premises to be searched or of the items to be seized

      •  Searches beyond die scope of die warrant

      •  Failure to follow appropriate procedures  in executing or returning die warrant.
     In order for a warrant, or evidence obtained pursuant to it, to be successfully challenged, in whole
     or in part, usually someone must make a prejudicial mistake at some point in die warrant process.
     If die mistake is sufficiently serious, an entire case could be lost. The procedures for obtaining,
     executing, and returning a warrant are well defined and established and must be followed as closely
     as possible.
4.6.2 SEEKING A PRE-INSPECTION WARRANT
A warrant may be obtained prior to me inspector entering die facility to conduct die inspection.  The pre-

inspection warrant is different from a warrant received after an inspection has begun in mat it does not

require diat a facility official deny entry to an inspector.  A pre-inspection warrant may be issued at die



November 1992                               4-18            TSCA 8ft 5/8 Inspection Guidance
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 Chapter Four	__	Inspection Management

 discretion of the Regional office. The inspector may want to consider obtaining a pre-inspection warrant
 if one of the following situations exists:
          A violation is suspected that could be covered up during the time needed to secure a warrant
          after the inspector arrives on site.
          Prior correspondence with facility officials (e.g., review of EPA records) or other contact with
          such officials provides reason to believe that entry will be denied when the inspector arrives
          The facility  is unusually remote from  the Regional office or a U.S. District Court so that
          obtaining a warrant at a later stage in the inspection process would be inconvenient to EPA.
4.7  THE OPENING CONFERENCE
4.7.1  PURPOSE
Once the EPA inspector has presented her/his credentials and the required notice for conducting an
inspection, it is time for the opening conference.  The inspector should ask whether a conference room
or office is available where s/he can conduct the opening conference and review facility records and files.
The opening conference provides an  ideal opportunity for the inspector to strengthen EPA-industry
relations. The inspector's role, in addition to that of determining compliance problems at facilities subject
to TSCA, can be that of an educator and public relations liaison with industry.  The inspector can serve
in this role throughout the inspection, but especially during the opening and closing conferences.

The inspector should be prepared to demonstrate her/his thorough understanding of the major  sections
of TSCA (i.e.,  those under which EPA compliance inspections are conducted) and  the applicable
regulations. Industry must  also be familiar with the requirements of TSCA and the regulations  in order
to comply  with the law.  Therefore,  it is crucial for inspectors to be well-versed in TSCA  and the
regulations promulgated  pursuant to it,  including any new regulations, as  they  are published in the
Federal Register.  The inspector should always have copies of such regulations on hand.  During the
course of an inspection, it may be necessary to refer some industry questions or requests (e.g., for TSC A-
related publications) to  the TSCA Hotline or to refer other matters to  appropriate EPA Region or
Headquarters staff.

During die opening conference, the inspector should have the following objectives:

      •  Establish a rapport with facility officials

TSCA H 5/8 Inspection Guidance            4-19                               November 1992
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 Inspection Management	Chapter Four
          Conduct the meeting on a positive and professional note
          Answer questions concerning TSCA and applicable regulations and have copies of TSCA
          available upon request plus citations to any applicable regulations
          Do not overstep authority to accommodate facility officials (e.g., do not give opinions about
          the acceptability of facility practices or whether the facility is in compliance with TSCA and/or
          applicable regulations)
          Collect and document necessary data to support Case Development Officers (in the Regions and
          at EPA Headquarters) in their efforts to bring necessary enforcement actions; for example,
          collect background facility information (i.e., sales revenue) necessary to assess the facility's
          ability to pay
          Update existing facility records on file at EPA Regions and Headquarters.
4.72  PROCEDURES
The inspector should begin the opening conference by outlining inspection objectives in general terms to
inform facility officials of the purpose and scope of the inspection. The inspector should then present
the facility owner .(or her/his designated agent) with the TSCA Inspection Confidentiality Notice (Figure
4-2). This notice informs the facility representative of the right to claim as CBI any information (e.g.,
documents, records, physical samples, or other material) collected from die facility during the inspection.
Facility officials should also be briefed on EPA's CBI procedures and on their right to make CBI claims
(see Section 4.7.3).

The inspector should then describe the inspection plan (prepared prior to the  opening conference) to
facility officials. By providing a description of the inspection plan, the inspector fosters an atmosphere
of cooperation between EPA and the facility, which is important for ensuring an understanding by both
parties of TSCA compliance issues. By keeping the discussion of die inspection plan general (i.e.,  by
not disclosing all details of all the types of records and  other data that will be inspected and perhaps
copied), the inspector can avoid providing advance warnings to facility officials.

The inspector should keep in mind throughout the opening conference the need to update existing facility
records in EPA Regional and Headquarters files.  Information  may be available in annual reports,
advertising solicitations, or stockholders reports.   This information may  include the  following items:
length of time in business; types of products manufactured; plant site locations; estimated number and

November 1992                              4-20             TSCA $9 5/8 Inspection Guidance
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 Chapter Four
                                         Inspection Management
                                         FIGURE 4-2
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TSCA 99 5/8 Inspection Guidance
              4-21
November 1992
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 Inspection Management	Chapter Four


 types of employees; general description of physical facilities; general financial information; corporate

 structure (parent company and subsidiary); names of corporate officers;  and management structure.


 The most important objective of the opening conference is to obtain as much information concerning the

 particular facility's operations and practices as possible.  In addition, the inspector should use the opening

 conference to question facility officials about such practices, operations, and any other data that may not

 have been included  in EPA records or that require clarification.  The inspector should refer to the

 facility's organizational chart to learn who is in charge of what operations at the facility and whom to
 contact for additional information.


 Important data to gather at the opening conference includes the following:
         Type and extent of operations conducted at die facility. Inquire about the type of operational
         activities that take place at the facility from an operational perspective,  including details on
         manufacturing, importing, processing, research and development (R&D), etc.

         Types of chemicals.  Obtain information on the types of chemicals processed, manufactured,
         imported, sold; etc.  Also obtain information on the nature and extent of any R&D activities
         at the facility and what chemical substances are the subjects of these activities.

         Types of records retained by facility.  Gather information on the types of records maintained
         by the facility to record manufacture, imports, sales, inventory, R&D, etc.

         TSCA-related policies.  Obtain copies of any facility policies related to TSCA Sections 4, 5,
         8, 12, and 13.  Any differences between these policies and the actual requirements of these
         sections of TSCA  should be  brought to the immediate attention of facility officials, without
         discussing whether there are any potential or actual violations of TSCA.

         Staff/employee 'nfi?m9tion   Obtain information concerning die number of full and part time
         employees and what percentage of employees work in various areas, including manufacturing,
         processing, sales, and RAD.

         Cflirnflrate fiscal year.  Ascertain the corporate fiscal year of the facility for the purposes of
         reporting under Section 8(a) and inventory updates.

         TSCA applicability to facility operations.  Verify that facility operations and programs  have
         not changed in such a way as to affect the applicability of TSCA to facility operations.  For
         instance, the inspector may learn that a facility has recently obtained a new permit to store
         wastes on site  or that  h no longer manufactures a  particular chemical.  Obtaining  such
         information will allow the inspector to revise the inspection plan as necessary.

         Existing facility environmental  programs.  Ask whether any environmental programs are in
         place at  the facility (e.g.,  effluent sampling,  analysis, reporting, training,  inspection,
November 1992                              4-22            TSCA 89 5/8 Inspection Guidance
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 Chapter Four	Inspection Management


          maintenance of pollution control equipment, emergency response).  The name(s) and telephone
          numbers of any person(s) in charge of these programs the facility should be obtained.

      •   Key contact persons and accountability.  Determine the facility's chain-of-command  in cases
          of emergency and the responsibilities of various staff members in the facility operations.
To save time, the inspector should resolve logistical issues at the opening conference in preparation for

the actual inspection.  The following factors should be considered:
          Having facility  official accompany inspector.  Before the inspection is conducted,  make
          arrangements with facility officials for a facility representative to accompany the inspector on
          the inspection. The representative should be able to describe facility layout and operations and
          to  indicate  what  data, records,  etc., should  be  claimed as CBI.  (Facility  claims of
          confidentiality may only be made by an individual with the authority to make such claims, as
          discussed in Section 4.7.3.3.)

          Establishing a  meeting schedule.   Arrange  for a schedule of necessary meetings  to be
          developed, based on the inspection plan and the inspector's understanding of the responsibilities
          of various facility officials.  This schedule will allow  individuals enough time to prepare for
          discussions with the inspectors.

          Scheduling closing conference.  Set a specific time  and place for  the  closing conference
          (discussed in Section  4.9).  This conference  will provide a final  opportunity to gather
          information from facility officials, to answer questions, and to complete administrative duties.
          The closing conference will also provide a forum for summarizing the inspection.
4.7.3 TSCA CONFIDENTIAL BUSINESS INFORMATION


4.7 J.I  TSCA INSPECTION CONFIDENTIALITY NOTICE

The  TSCA inspector  must present the facility owner (or her/his designated  agent) with the TSCA

Inspection Confidentiality Notice (Figure 4-2) at the start of the opening conference. This notice informs

the facility representative of the right to claim any information  (e.g.,  documents, records, physical

samples, or other material) collected from the facility  during the inspection as confidential.  All CBI

claims must be made by completing the Declaration of Confidential Business Information form (Figure

4-3).  This form can protect many items from public disclosure.


The inspector should also have available, if possible certification that s/be is authorized to have access

to CBI.  A handwritten note from the DCO is sufficient or the facility can  call  the DCO for such

information.



TSCA fig 5/8 Inspection Guidance             4-23                               November 1992
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Inspection Management
                             Chapter Four
                                FIGURE 4-3
           DECLARATION OF CONFIDENTIAL BUSINESS INFORMATION
UiMed Sues Environmental Protection Agency
A |-|%ft Washington. D.C. 20460
DECLARATION OF CONFIDENTIAL BUSINESS INFORMATION

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 Chapter Four                                       	         Inspection Management
 4.7.3.2  DECLASSIFICATION OF CBI
 The facility owner or designated agent should be informed that an authorized facility official may
 declassify information claimed  as CBI in the original submission of the Declaration of Confidential
 Business Information.  However, the inspector must inform the facility official that such declassification
 cannot be made verbally, but rather must be made through a letter waiving confidentiality sent to the EPA
 DCO for OPPT.  A separate letter must be sent for each item for wbiclr confidentiality is to be waived.

 4.7.3 J  CONFIDENTIALITY CLAIMS
 The inspector must determine whether the facility official to whom the Confidentiality Notice was given
 is authorized by the facility to make  claims of confidentiality. The official's signature must be obtained
 on the notice certifying that the person does or does not have such authority.  The facility owner is
 assumed to have such authority.  In most cases, it is expected that the agent designated by the owner will
 also have such authority. It is possible that the facility officials will want to consult with their attorneys
 concerning this issue.

 If no one at the site has the authority to make business confidentiality claims, the notice and other
 inspection materials should be sent to the CEO of the company within 2 days of the inspection.  The CEO
 will then have 7 calendar days in which to make confidentiality claims.  During this 7-day period, the
 inspector should follow routine security measures in the event that records taken during the inspection
 are subsequently claimed as CBI.  For example, the inspector should file the records  in a secured area
 instead of leaving them on her/his desk.

The facility official may also designate a company official, in addition to the CEO, who should also
receive a copy of the notice and other inspection materials. Space is provided on the notice form for such
a designation.

4.8  INSPECTION PLAN REVISIONS
After the opening conference, the inspector should have sufficient information to decide whether any
substantial changes to the inspection plan are necessary.  If no changes to the plan are necessary, the
inspector should proceed with the inspection. If changes are required, then inspection activities should
be altered accordingly and appropriate notes made  in the inspector's notebook.

TSCA S3 5/8 Inspection Guidance            4-25                                November 1992
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 Inspection Management	Chapter Four

 When revising the inspection plan, the inspector should keep in mind time constraints and resource
 limitations (e.g., funds and manpower) and ensure that the revised inspection can be conducted using the
 same equipment that has been brought on site.

 If the review is being conducted by an inspection team (instead of by a single inspector), revision of the
 inspection plan should focus on the appropriateness of task assignments in addition to other concerns.
 Assignments given to inspection team members should be re-evaluated and adjusted as necessary based
 on information gathered during the opening conference as well as the expertise and responsibilities of the
 various inspectors.

 When the inspection team is actually assembled on site, where first-hand  observations of facility size,
 layout, and complexity are possible, it is important to determine again whether inspection activities can
 actually be  completed in  the allotted time and whether each  team member's  task assignments are
 reasonable given time and scheduling constraints.  The inspection team may excuse themselves and ask
 to have a few moments alone to discuss possible scheduling modifications.

 The various procedures the inspector should follow in determining compliance with Sections 4,5, 8, 12,
 and 13 of TSCA are discussed in Chapters 5 through 8.

 4.9 THE CLOSING CONFERENCE
 4.9.1 PURPOSE
 The purpose of the  closing conference is to allow the inspector and facility representatives to resolve final
 administrative matters concerning the inspection. At the conclusion of the TSCA inspection, the inspector
 holds a closing conference with facility officials to summarize the inspection proceedings, complete and
 submit to facility representatives certain forms related to the inspection (discussed in Section 4.9.2), and
 obtain from facility officials any outstanding records or other data needed by the  inspector.

4.9.2 PROCEDURES
The inspector should summarize the inspection findings in an objective and factual manner. During the
 conference,  it is critical that the inspector refrain from drawing conclusions regarding  any potential
 violations that may have been discovered during the inspection.  For example, an inspector conducting
 an inspection of a facility operating with an R&D exemption might report the absence or presence of the

 November 1992                              4-26            TSCA  8ft 5/8 Inspection Guidance
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Chapter Four	Inspection Management

following information:  1) copies of or citations to information reviewed  to determine risks, and 2)
documentation of the nature and method of risk notification. By reporting whether s/he discovered this
information, the inspector is presenting her/his inspection findings.   If, however, the inspector links
her/his findings to the Section of TSCA which the facility has potentially violated, then the inspector has
discussed a potential violation.  The same objectives that govern the manner in which an inspector should
conduct the opening conference (discussed in Section 4.3) apply to the closing conference as well.

The inspector should clarify any final questions and provide the facility officials with the opportunity to
ask any final questions. If the inspector wants to obtain additional documents not available at the time
of the closing conference, the inspector should request these documents and agree upon a reasonable date
by which the facility officials should submit the documents. However, the inspector should make every
effort to obtain all necessary records during the inspection, thus keeping the need for  follow-up
information to a minimum.  The inspector should request that any documents that the company  may
decide to submit to EPA Headquarters or correspondence with EPA resulting from the inspection be
copied and sent to her/him.

During the closing conference, the inspector must also require the facility officials to complete 2 forms
related to the inspection process. These forms are the Declaration of Confidential Business Information
(Figure 4-3) and the Receipt for Samples and Documents (Figure 4-4).
     •   Receipt for samples and documents. The inspector must provide facility officials with a copy
         of the TSCA Receipt for Samples and Documents, which lists and describes each document and
         sample taken by the inspector from the facility.  This receipt must be signed and dated by a
         facility official and the inspector. The receipt should identify the following:
             A description of all physical samples taken
             A description of all records, photographs,  or other property taken (particularly crucial
             when inspecting with a warrant)
         -   A brief description of information  claimed as CBI (which should  be listed on  the
             Declaration of Confidential Business Information form).
         The purpose of this detailed receipt is to show that facility officials knew exactly what
         documents and samples were taken  and  to allow  full  review by  facility officials  of the
         documents and samples collected so that confidentiality claims can be made.
TSCA S$ 5/8 Inspection Guidance            4-27                               November 1992
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inspection Management
                                             Chapter Four
                                     FIGURE 4-4
                     RECEIPT FOR SAMPLES AND DOCUMENTS
                           Unttad
       Washington. D.C. 20460
     Tcodc SuMtvw Cortrol Act
RECEIPT FOR SAMPLES AND DOCUMENTS
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November 1992
             4-28
TSCA fifi 5/8 Inspection Guidance
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 Chapter Four        	Inspection Management
          Declaration of CBI. The inspector must also provide facility officials with a copy of the TSCA
          Declaration of Confidential Business Information.   This form must include a list of each
          document, photograph, or other data claimed by an authorized facility representative as CBI.
          Both the inspector and the claimant (i.e., the facility official) must sign and date the completed
          document.

          The inspector should not suggest or advise that any document or other item be claimed as
          confidential.  The decision must be left entirely to the facility official.  However, the inspector
          may and should answer questions concerning claims of confidentiality (e.g., when a claim is
          considered appropriate). The inspector should note that CBI claims on occasion are unfounded.
          CBI claims should be considered for review and challenge in a manner consistent with the
          requirements of 40 CFR §2.203. IMD personnel can provide assistance to the inspector in
          reviewing CBI claims to determine if they are valid.  The inspector should inform facility
          officials that each declared item should meet all four criteria listed on the claim form and that
          those that do not meet all four criteria, should not be listed as CBI. (For additional information
          on CBI, see Chapter 3.)

          The inspector should keep in mind  that some data may  have been declared  CBI during the
          inspection.  These items should be confirmed with facility officials and added to the CBI
          declaration form.

          No authorized claimant. If no on site facility official is authorized to  make CBI claims at the
          time of the closing conference, the inspector should:

             Make a copy of the completed and signed Receipt for Samples and Documents.

             Make  a  copy of the completed and signed  TSCA Inspection Confidentiality Notice
             (discussed in Section 4.7.4.1).

          -   Complete the top portion only (i.e., investigation identification information, firm  name,
             inspector address, firm address) of the Declaration of Confidential Business Information
             form.

             Mail the three forms (above) certified, return-receipt-requested to the CEO of the facility
             within 2 days of the inspection.  (The CEO will have 7 calendar days to make CBI claims
             on the declaration form.)

             If another company official has also been designated to make CBI claims, the three forms
             should be sent to that official in addition to the CEO.

         The inspector need not take any  measures during the 7-day period mentioned above beyond
         following the routine security procedures normal for inspection data collected from the facility.
         However, immediately upon notification of the Regional  DCO by  the appropriate facility
         officials (i.e., those authorized  to  claim CBI) that data is being claimed CBI,  EPA will
         commence TSCA-CBI procedures with respect to such data. If a CBI claim is made, it is the
         responsibility of the  DCO to notify all parties (i.e., inspector, laboratory, case preparation
         staff, and any others who may be handling the information) of the fact that the data is CBI and
         to log the material as required.
TSCA g§ 5/8 Inspection Guidance            4-29                              November 1992
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Inspection Management	Chapter Four

4.9 J  COMPLIANCE OUTREACH
Since the inspected is often the only contact between EPA and the regulated industries, s/he should be
aware of opportunities to promote compliance with EPA regulations.  The closing conference provides
an ideal opportunity to offer various kinds of help to facility officials.  The inspector will have just
completed an inspection and will have first-hand  knowledge of questions,  problems,  and possible
solutions.

However, in this role,  die inspector should be careful to answer only those questions that are within
her/his ability or authority.  The inspector should never recommend that a particular step be taken to
address a problem. Such advice may be wrong, and  if the facility is later found to be in noncompliance,
EPA's ability to pursue an enforcement action would be jeopardized. However, the inspector can offer
or suggest resources that are  available to facility officials to help solve  problems (e.g., technical
publications, special services).  Inspectors should refer questions and problems to other EPA personnel
as needed, and follow  up with  those personnel when practical to see that facility officials receive a
response.

Since the purpose of the inspection process is to promote compliance, as well as to identify violations,
it is important for the inspector to help raise the level of a facility's awareness of TSCA requirements.
The closing conference  is an ideal opportunity for the inspector to promote compliance by disseminating
EPA literature to the facility. The following publications may be recommended or given to the facility
to increase their awareness of TSCA requirements.

Toxic Substances Control Act
     •   Public Law 94-469. October 11,  1976. Toxic Substances Control Act.
         An act to regulate commerce  and protect human health and the environment by requiring
         testing and necessary use restrictions on certain chemical substances, and for other purposes.
     •   Public Law 97-129. December 29, 1981. Amendment to the Toxic Substances Control Act.
         An act to amend the Toxic Substances Control Act to authorize appropriations for fiscal years
          1982 and 1983.
     •   U.S.  EPA.  July 1990.  "Subchapter R:  Regulations; Toxic  Substances Control Act." In
         Federal Register, vol. 40, parts 700-789 and 790-end. Washington, DC.
         Regulations developed by EPA to guide the implementation and enforcement of TSCA.

November 1992                             4-30             TSCA 8ft 5/8 Inspection Guidance
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 Chapter Four	           	   Inspection Management
 General Information

      •  U.S. EPA. June 1987.  The Layman's Guide to the Toxic Substances Control Act.
         Office of Toxic Substances.  Washington, DC.

         A discussion of the major provisions of TSCA intended to familiarize the public with the law.

      •  U.S. EPA. 1985. TSCA Chemical Substances Inventory.  Washington, DC.

         The 1985 edition updates the printed Inventory and supersedes previous versions.  The new
         Inventory is  not a list of toxic substances but a register of the more than 63,000 chemical
         substances in the United States regulated by TSCA.


 Section 5 Information

      •  U.S. EPA. November 1991. New Chemicals Program (EPA-560/1-91-005). Office of Toxic
         Substances. Washington, DC.

         A Q&A fact paper about EPA's New Chemicals Program, which is part of the Office of Toxic
         Substances and which reviews PMN submissions to identify substances requiring regulatory
         action.

      •  U.S. EPA.  September 1983.  "Supplementary Premanufacture Questions and Answers."
         Washington,  DC.

         A compilation of PMN-related questions and answers, including coverage of what must be
         reported, data on the new chemical, confidentiality, and who must report.

      •  U.S. EPA.  No date.  "Background on PMNs, Section 5(e) Orders,  and Significant New Use
         Rules and Summary of Direct Final Rule."  Washington, DC.

         A one-page fact sheet.

      •  U.S. EPA. No date.  "Toxic Substances Control Act Section 5(a)(2) Significant  New Use
         Rule." Washington, DC.

         Fact sheet
Section 8 Information

     •   U.S. EPA.  June 1991.  TSCA Section 8(e) Reporting Guide.  Office of Toxic Substances.
         Office of Pesticides and Toxic Substances. Washington, DC.

         A guide for the regulated community complying with Section 8(e) of TSCA intended to make
         certain information more accessible and to  provide both general and specific examples of
         submitted information, plus EPA's comments on such submissions.
TSCA 55 5/8 Inspection Guidance           4-31                             November 1992
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Inspection Management            	     	                  Chapter Four
      •   U.S. EPA.  June 1989.  Comprehensive Assessment Information Rule:  Question and Answer
         Document., Washington, DC.  (Also March 1989 and December 1988 versions)

         A section-by-section listing of common questions,  and their answers, asked by those in the
         regulated community.

      •   U.S. EPA.  September 1988.  "TSCA Section 8(c) Allegations of Significant Adverse actions. *
         Existing Chemical Assessment Division, Office of Toxic Substances. Washington,DC.

         A Q&A fact sheet about Section 8(c) of TSCA.

      •   U.S. EPA.  August 1990. Instructions, for Reporting for the Partial Updating of the TSCA
         Chemical Inventory Data Base (EPA 560/7-90406). Office of Toxic Substances. Washington
         DC.

      •   U.S. EPA.  No date. "Toxic Substances Control Act (TSCA): TSCA Section  8(a)."

         Q&A fact sheet.

      •   U.S. EPA.  No date. "Toxic Substances Control Act (TSCA): TSCA Section  8(c)."

         Q&A fact sheet.

      •   U.S. EPA.  No date. "Toxic Substances Control Act (TSCA): TSCA Section  8(d)."

         Q&A fact sheet.


Sections 12 and 13 Information

     •   U.S.  Department of the Treasury.  August 1, 1983.   "Customs Regulations Amendments
         Relating to Special Classes of Merchandise.  Final Rule."  In Federal Register, vol. 48, p.
         34734.  Customs Service. Washington, DC.

         This  rule amends the Customs  Regulations to regulate the entry of any chemical substance
         imported in bulk or as part of a mixture into the customs territory of the United States.

     •   U.S.  EPA.   April 1991.   Toxic Substances Control  Act:  A Guide for  Chemical
         Importers/Exporters:  An Overview  (EPA 560/1-91-001).  Office of Toxic Substances.
         Washington, DC.

         This publication summarizes the requirements of sections 12(b), Exports, and 13, Imports, of
         TSCA, and the rules and policies issued under these sections.

     •   U.S.  EPA.  December  16, 1980.  "Chemical  Imports and Exports; Notification of Export.
         Final Rule." In Federal Register, vol.  45, p. 8284S. Washington, DC.
November 1992                            4-32            TSCA M 5/8 Inspection Guidance
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Chapter Four                    	         	    Inspection Management
         This rule outlines procedures for exporters to submit notifications to EPA under section 12(b)
         ofTSCA.
Existing Chemicals

     •   U.S. EPA.   No date.   TSCA Section 5(a)(2) Significant New Use Rules for  Existing
         Chemicals, Frank Kover, Chief, Chemical Screening Branch, (202) 382-3436.

     •   U.S. EPA.  No date. For Your Information (FYI) Submissions: An Overview, Jacqueline
         Favilla, FYI Coordinator, OTS, (202) 475-8823.

     •   U.S. EPA.  No date. TSCA Section 4 - Test Rules, Chief, Test Rules Development Branch,
         (202) 475-8130.

     •   U.S. EPA.  No date. TSCA Section 8(c) Allegations of Significant Adverse Reactions, TSCA
         Assistance Office, (202) 554-1404.

     •   U.S. EPA.  No date. Comprehensive Assessment Information Rule (CAIR), Joan Kuchkuda,
         Chemical Screening Branch, (202) 382-3832:

     •   U.S. EPA.   No date.   Chemical  Advisories, Dr. Laurence S. Rosenstein, Chief, Risk
         Assessment Branch, (202) 382-3832.

     •   U.S. EPA.  No date. Section 8(e) of the Toxic Substances Control Act:  An Overview, David
         R. Williams TSCA Section 8(e) Coordinator, OPPT, (202) 382-3468.

         A  collection  of fact sheets and designated  EPA contacts from the  Existing Chemicals
         Assessment Division of OPPT.
TSCA 88 5/8 Inspection Guidance            4-33                             November 1992
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Chapter Five                                         TSCA Section 4 Inspections
Chapter Five

TSCA Section 4  Inspections
                                                                 Page


5.0      TSCA SECTION 4 INSPECTIONS  	 5-1

5.1      INTRODUCTION 	 5-1

        5.1.1    CONSENT AGREEMENTS 	 5-1
        5.1.2    SELECTION OF A CHEMICAL SUBSTANCE FOR A TEST RULE ... 5-2
        5.1.3    APPLICABILITY OF TEST RULES	 5-2

5.2      INSPECTION OBJECTIVES  	 5-5

        5.2.1    PHASE 1 INSPECTION	 5-5
        5.2.2    PHASE 2 INSPECTION	 5-7
                            LIST OF TABLES

TABLE 5-1 40 CFR PART 799 SUBPART C CHEMICALS SUBJECT
         TO TESTING CONSENT ORDERS 	 5-3
TABLE 5-2 40 CFR PART 799 SUBPART B SPECIFIC CHEMICAL TEST RULES	5-8
TABLE 5-3 40 CFR PART 799 SUBPART D MULTICHEMICAL TEST RULES	5-9
TSCA §§ 5/8 Inspection Guidance          5-i                       November 1992
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TSCA Section 4 Inspections         	                              Chapter Five
                                  BLANK PAGE
November 1992                          S-ii           TSCA 8§ 5/8 Inspection Guidance
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Chapter Five	TSCA Section 4 Inspections

                           5.0  TSCA SECTION 4 INSPECTIONS

This chapter addresses inspections under Toxic Substances Control Act (TSCA) Section 4, which provides
the U.S. Environmental Protection Agency (EPA) with the authority to establish test rules applicable to
companies manufacturing, importing, or processing chemical substances that EPA determines are subject
to testing requirements. Another objective of TSCA Section 4 inspections is to ensure that facilities that
perform the required tests comply with prescribed Good Laboratory Practice (GLP) Standards which
represent the procedural and quality control aspects of a TSCA Section 4 test rule. This chapter does not
address the GLP inspections.   However,  they are being performed  by the Office  of Compliance
Monitoring  (OCM)  Laboratory  Data  Integrity  Assurance Division, the  National  Enforcement
Investigations Center (NEIC), or by Regions 2, 3, and  5, in conjunction with OCM.

S.I INTRODUCTION
TSCA Section 4 authorizes EPA to require manufacturers,  importers, and processors of chemical
substances  and mixtures to test select chemicals to determine whether they have adverse health or
environmental  effects.   In addition, EPA has implied authority to enter  into enforceable  consent
agreements requiring testing in which they provide procedural safeguards equivalent to those that apply
when  testing is conducted by rule.

5.1.1  CONSENT AGREEMENTS
Consent agreements adopted pursuant to TSCA Section  4 are "orders" for the purposes of TSCA Section
IS, and EPA regards failure to  comply with any aspect of a consent agreement as a "prohibited act"
under TSCA Section IS.   EPA  and  industry can conserve resources by reaching consent agreements
instead of using  the formal rulemaking procedures, but consent agreements have limitations.  While
enforceable against its signatories, a consent agreement is not enforceable against a non-participatory
party, and it does not set in motion the reimbursement  procedures.

EPA uses enforceable consent agreements to accomplish testing when a consensus exists among EPA,
affected manufacturers, importers, and/or processors, and interested members of the public concerning
the need for and  scope of testing. If such a consensus does not exist and EPA believes that it can make
the findings specified in TSCA Section 4(a) (and listed  below), EPA  will initiate proceedings to
TSCA §§ 5/8 Inspection Guidance             5-1                              November 1992
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 TSCA Section 4 Inspections	Chapter Five

 promulgate test rules. Chemicals subject to testing consent orders (as of March 4, 1992) are listed in
 Table 5-1.

 Hie inspector should note that the responsibility of enforcing compliance with consent agreements belongs
 to OCM's Laboratory Data Integrity Assurance Division.  The inspector should be aware of the contents
 of a consent agreement.  For example, a consent agreement may also require that  if EPA promulgates
 a SNUR applicable to the test chemical under TSCA Section 5(a)(2), the consent agreement will have the
 status of a test rule for  purposes of TSCA Section S(b)(l)(A), and manufacturers, importers, and/or
 processors signing the agreement must comply with the data submission requirements imposed by that
 provision.

 5.1 J  SELECTION OF A CHEMICAL SUBSTANCE FOR A TEST RULE
 EPA exercises its authority under Section 4 when it can make certain statutory findings about the
 substances of concern and when industry fails to develop data on its, own;  The required findings are that
 a chemical may present a substantial risk, there are insufficient data already available to  perform a
 reasoned risk assessment, and that testing is required to develop such data.  Test rules can be found at
40 CFR Part 799.

The Interagency Testing  Committee (TTC) was established to recommend chemicals to EPA for priority
testing.  The total number of chemical substances and mixtures on an ITC list may not exceed SO. Within
 12 months of EPA's receipt of an ITC recommendation, EPA must either initiate rulemaking requiring
testing or must publish its reasons for not doing  so.

5.1 J  APPLICABILITY OF TEST RULES
Each test rule will specify for its selected chemical(s) whether the responsibility to conduct the required
test results is borne by (1) each person who manufactures or imports or intends to  manufacture or import
the chemical; (2) each person who processes or  intends to process the chemical; or (3) manufacturers,
importers, and processors.

 Manufacturers, importers, and processors of the chemicals identified in a TSCA  Section 4 rule may be
 required to test these chemicals and bear the costs.  To avoid duplication of testing  activity and to share
 costs, two or more companies subject to a test rule may join together to form a  "consortium" or "joint
November 1992                              5-2            TSCA §§ 5/8 Inspection Guidance
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Chapter Five
                    TSCA Section 4 Inspections
                         TABLE 5-1 40 CFR PART 799 SUBPART C
                    CHEMICALS SUBJECT TO TESTING CONSENT ORDERS
$**0<*«**l
Aniline
1.1.1-Trichloroetbine
Dt-n-butyl phlhaUte
Di-n-hexyl phthilite
2-aitrauiliiie
2-chtofouuliae
3.4-dicUorouulino
2.4-dinhRMniline
2.6-dichloro-4-nitn>-»iiiline
4-nitraniline
4-chlomnilino
Triethyleoe glyeol mooomethyl ether
TnethyleiiB gtycol moooeiliyl eftcr
Di-2-ethylhexylphihaIiu
DttridwylphduUte
Dimethyl pfathalate
TriethylMe glyeol monobutyl ether
3 B4-Dichlorabe&zoinfluofido
Octimelhylcyclotctiifiloxiiie
Methyl len-butyl ether
C.I. Dupene Blue 79:1 Acettmide.N-(5-{bii(2-(«cetyloxy)
ethyll«niii»fr2-[(2^Kwio^,6^iiiiiroplieiiyl)i»»l 4 aaeihoxy-phenyl}-
Diuadeeyl phdulate
O«tf
-------
 TSCA Section 4 Inspections	Chapter Five

 venture"  to sponsor a member company or a qualified third party to conduct the required tests and to
 submit data on behalf of the consortium or joint venture.  The law provides for sharing of the testing
 costs by all manufacturers, importers, or processors subject to a particular test rule. Other companies
 are typically granted an exemption from the testing regulation if EPA determines that the chemical they
 manufacture or process is equivalent to a substance for which data have already been submitted, making
 further testing duplicative.

 If a company manufactures, imports, or processes a chemical substance subject to a TSCA Section 4 test
 rule, then the company must either submit a letter of intent to conduct testing or apply for an exemption
 from the  requirements of the applicable  test rule.  Processors are typically granted a conditional
 exemption on the assumption that manufacturers will submit the letter of intent. EPA considers letters
 of intent to test as commitments to sponsor the tests for which they are submitted, unless EPA agrees to
 an exemption application when more than one person indicates an intent to sponsor  equivalent tests.

 TSCA Section 4 requires companies that receive an exemption before the end of the reimbursement period
 to provide "fair and equitable reimbursement" to those manufacturers or processors who  had to bear the
 full cost of testing the subject chemical.  The reimbursement period for any test data  for a chemical
 substance or mixture is a period beginning on the date the test data are submitted and  ending 5 years later
 or at the expiration of a period that EPA determines was necessary to develop the data, whichever is
 later.  If the parties cannot agree  on the amount and  method of reimbursement, TSCA Section 4
 authorizes EPA to promulgate rules for the determination of fair and equitable reimbursement for costs
 incurred with respect to a chemical substance or mixture.  EPA has promulgated a Data Reimbursement
Rule at 40 CFR Part 791.  For any questions relating to the reimbursement process, the inspector should
contact the program office.

 Rigorous enforcement and compliance with TSCA Section 4 test rules are vital to the overall effectiveness
of TSCA  since data submitted pursuant to TSCA  Section 4 test rules allow EPA  to determine which
 chemicals should be further scrutinized through substantive control regulations under TSCA Sections 6
 and 7. TSCA Section 4 data, in conjunction with information received under TSCA Section 5, may also
 serve as the basis for a decision to limit or prohibit the manufacturing or processing of a new chemical
 under TSCA Sections S(e) or 5(f).
November 1992                               5-4            TSCA §8 5/8 Inspection Guidance
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Chapter Five	TSCA Section 4 Inspections

5.2  INSPECTION OBJECTIVES
The inspection objectives to determine compliance with TSCA Section 4 are:
         To verify that those companies subject to a TSCA Section 4 test rule submitted a letter of intent
         to conduct the required testing, and that the information submitted in the letter of intent is
         truthful,  complete, and timely (Phase 1).
         To verify that those companies subject to a TSCA Section 4 test rule that did not submit a letter
         of intent during a Phase 1 inspection applied for and received an exemption,  and that the
         information submitted in the exemption application is truthful, complete, and timely (Phase 1).
         To identify companies that are manufacturing, importing, or processing a chemical subject to
         a TSCA  Section 4 test rule  and that have failed to submit a letter of intent to conduct the
         required  testing or applied and received an exemption from testing (Phase 2).
The Phase 2 inspection (i.e., identify failure to submit a letter of intent to test or obtain an exemption)
is usually done in conjunction with the TSCA Section 5 general inventory pan of the inspection (discussed
in Chapter 6).  During the Phase 2 inspection, the inspector will verify that those firms eligible for an -
exemption from the testing requirements of a TSCA Section 4 rule applied for and received an exemption.

5.2.1  PHASE 1 INSPECTION
The inspector should  review an official copy of the company's letter of  intent to conduct testing or
application for an exemption before the inspection, if possible. These documents can be obtained from
the Information Management Division (IMD) through an Enforcement Request (discussed in Chapter 3).
The following guidelines should assist the inspector in determining compliance with this aspect of a TSCA
Section 4 test rule and its implementation.

The inspector should review company documentation (i.e.,  correspondence) to verify that the company
notified EPA by letter no later than 30 days after the effective date of the test rule of its intent to conduct
testing.  The effective date of each test rule is stated in one of the last paragraphs of the applicable test
rule.

The inspector should verify that the letter of intent is accurate and complete by checking that the letter
includes the following information:
TSCA §§ 5/8 Inspection Guidance             5-5                                November 1992
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 TSCA Section 4 Inspections	Chapter Five

      •   Identification of the test rule
      •   Name, address, and telephone number of the firm(s) sponsoring the tests
      •   Name, address, and telephone number of the appropriate  individual to contact for further
          information
      •   For sponsors participating in a testing consortium, a list of all members of the consortium
      •   A list of the testing requirements (e.g., health or environmentateffects or other characteristics)
      «   If EPA is requiring testing of more than one representative substance, identification of the  test
          substance the sponsor(s) intends to use  in each test.

A company that is not  manufacturing, importing, or processing the subject chemical as of the effective
date of the test rule, or by 30 days after the effective date of the rule,  but that begins manufacturing,
importing, or processing the test chemical before  the end of the reimbursement period, must submit the
letter of intent to test or application for an exemption by  the date the manufacture, import, or processing
begins. The inspector should check the date on which the company commenced manufacture, import,
or processing of the chemical  and  verify that the letter of intent or an application for exemption was
submitted on or before that date.  If a letter of intent to test has been submitted  by the company,  the
inspector should then ensure that testing  protocols were  established and submitted in a timely manner.

If the company claims an exemption from a TSCA Section 4 test rule, the inspector should review facility
records (i.e., facility  correspondence) to verify that an application for an exemption from testing
requirements for the test rule has been submitted to EPA no later than 30 days after the effective date of
the test rule.

The inspector should verify that the exemption application contains the following:
     •   Identification of the test rule, the chemical identity, and the Chemical Abstracts Service (CAS)
         Registry Number of the test substance on which the application is based
     •   Specific testing requirements^) from which an exemption is sought and the basis for the
         exemption requested
     •   Name, address, and telephone number of the applicant
     •   Name,  address, and telephone number of the appropriate  individual to contact for further
         information
November 1992                               5-6             TSCA §§ 5/8 Inspection Guidance
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Chapter Five	                	                  TSCA Section 4 Inspections
      •  If required in the test rule to establish equivalence, the chemical identity of the test substance
         on which the application is based and the equivalence data specified in 40 CFR §790.85.
A company that is not manufacturing, importing, or processing the subject chemical as of the effective
date of the test rule, or by 30 days after the effective date of rule, but that begins manufacturing,
importing, or processing the test chemical before the end of the reimbursement period and is claiming
an exemption must  submit an exemption application by the date manufacture, import,  or processing
begins. The inspector should check the date on which the company commenced manufacture,  import,
or processing of the chemical and verify that the application was submitted on or before that date.

Companies that submit an application for exemption from testing requirements and have the application
approved must  then make  reimbursement payments to the company that did  the original testing on the
subject chemical.   Such payments  are negotiated  between the  two parties  involved; however, if an
agreement cannot be reached, EPA has  developed procedures (40 CFR Part  791) and  a  formula for
calculating costs (40 CFR  §791.40). The inspector should examine the facility records to  identify any
reimbursement  payments made by the company.  The reimbursement payment amounts, combined with
the inspector's knowledge of the production volume of the test rule chemical, and the national production
volume (obtainable from the program office during the followup stage of the inspection) will allow the
inspector to determine whether the facility is meeting its exemption and reimbursement requirements.
If no  reimbursement payments are identified, the company may  be  in violation of  its exemption
requirements.

5.2.2  PHASE  2 INSPECTION
The second phase of the inspection  identifies companies subject to a TSCA Section 4 test rule that have
failed to submit letters of intent to conduct testing.  During the inspection, the inspector should compare
the company's current list of manufactured, imported, or processed chemicals against the latest Chemicals
on Reporting Rules (CORR) list (see Appendix  7).  Lists of specific chemicals and  multichemical
substances for which test rules have been promulgated (as of July  1, 1991) are presented in Tables 5-2
and 5-3, respectively.  If the company's current inventory indicates the production of a  chemical or
multichemical substance subject to  a TSCA Section 4 test rule for which a letter of intent to  conduct
testing or an application for an exemption was not submitted, the  inspector should obtain (1) copies of
records that indicate the total volume of chemical manufactured,  imported, or processed, and (2) copies
of batch records and import records to determine the number of times the company may have  violated
TSCA §§ 5/8 Inspection Guidance            5-7                               November 1992
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TSCA Section 4 Inspections
                                Chapter Five
                          TABLE 5-2 40 CFR PART 799 SUBPART B
                            SPECIFIC CHEMICAL TEST RULES
AtifcaritH49e?R}
799.500
799.925
799.940
799.1051
799.1052
799.1053
799.1054
799.1250
799.1285
799.1550
799.1560
799.1575
799.1645
799.1650
799.1700
799.2155
799.2175
799.2200
799.2325
799.2475
799.2500
799.2700
799.3175
799.3300
799.3450
799.4000
799.4360
799.4400
799.4440
Subject Chemical '
Anthraquinone
Biphenyl
Buphciiol A
Monochlorobenzene
Dichlorobenzenes
Trichlorobenzenes
1 .2.4.5-Tetrachiorobenzene
Cresols
Cumene
1 ,2-Dichloropropane
Diethylene glycol butyl ether and diethylene
glycol butyl ether acetate
Diethylenetriamine (DETA)
2-Ethylhexanol
2-Elhylhexanoic acid
Fluoroalkenei
Commercial hexane
C9 aromatic hydrocarbon fraction
Hydroquinonc
Isopropanol
2-Mercaptobenzothiazole
Mesityl oxide (MO)
Methyl ethyl ketoxinte
Olcylamine
Unsubstituted phenylenediamines
Propylene oxide
Tetrabromobisphenol A
Tributyl phosphate
1,1,1-Trichlorocthane
Triethytene glycol monomethyl ether
CAS Number
684-65-1
92-52-4
80-05-7
108-90-7
95-50-1; 106-46-7
87-61-6; 120-82-1
95-94-3
95-48-7; 108-39-4; 106-44-5
98-82-8
78-87-5
112-34-5; 124-17-4
111-40-0
104-76-7
149-57-5
75-02-5; 75-38-7; 116-14-3
110-54-3:96-37-7
N/A
123-31-9
67-63-0
149-30-4
141-79-7
96-29-7
112-90-3
106-50-3; 1624-57-75
75-56-9
79-94-7
126-73-8
71-55-6
112-35-6
TSCA §$ 5/8 Inspection Guidance
5-8
November 1992
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Chapter Five
                    TSCA Section 4 Inspections
                         TABLE 5-3  40 CFR PART 799 SUBPART D
                             MULTICHEMICAL TEST RULES
Subject Chemical
Acetamide, 2-fluoro
Bis(2-chloroethoxy)methane
Bis(2-chloroisopropyl)ether
4-Bromobenzyl cyanide
Brotnofonn
4-Chlorobenzo-tnchlonde
2,4-D
Dibromomethanc
1 ,2-Dichlorobenzene
1,1-Dichloroethane
1 ,3-Dichloropropanol
Dihydrosafrole
Endrin
Ethyl methacrylate
Maleic hydrazide
Malononithle
Methanethiol
Methyl chloride
2-Nitrophenol
Pentachlorobenzene
Pentachlorodhane
1 ,2,4,5-Tctrachlorobcnzene
Tnchloromethanethiol
CAS Number
640-19-7
111-91-1
108-60-1
16532-79-9
75-25-2
5216-25-1
94-75-7
74-95-3
95-50-1
75-34-3
96-23-1
94-58-6
72-20-8
97-63-2
123-33-1
109-77-3
74-93-1
74-87-3
100-02-7
608-93-5
76-01-7
95-94-3
75-70-7
TSCA §§ 5/8 Inspection Guidance
5-9
November 1992
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TSCA Section 4 Inspections	Chapter Five

TSCA  since the relevant chemical became subject to a test rule.  Manufacturers, importers,  and
processors subject to a test rule who do not submit to EPA either a letter of their intent to conduct tests
or a request for an exemption from testing for each test rule are considered in violation of that rule
beginning on the 31st day after the effective date of the test rule or on the date manufacture begins.
November 1992                              5-10            TSCA §§ 5/8 Inspection Guidance
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Chapter Six	TSCA Section 5 Inspections

Chapter Six


TSCA Section 5 Inspections

                                                                   Page


6.0  TSCA SECTION 5 INSPECTIONS	  6-1

6.1  INTRODUCTION	  6-1

    6.1.1  PMN EXCLUSIONS AND EXEMPTIONS	  6-3
    6.1.2  INSPECTION SITES  	  6-6

6.2  PREMANUFACTURE NOTICE REQUIREMENTS 	6-8

    6.2.1  INSPECTION OBJECTIVES	  6-8
    6.2.2  PHASE 1 INSPECTION 	  6-11
    6.2.3  PHASE 2 INSPECTION 	  6-22

6.3  TSCA SECTION 5(e)/5(f) ORDER 	  6-23

    6.3.1  INSPECTION OBJECTIVES	  6-25
    6.3.2  INSPECTION GUIDELINES  	  6-25

6.4  SIGNIFICANT NEW USE RULE	  6-29

    6.4.1  RULE-MAKING PROCEDURES	  6-29
    6.4.2  SNUN REQUIREMENTS 	  6-30
    6.4.3  INSPECTION OBJECTIVES	  6-31
    6.4.4  INSPECTION GUIDELINES  	  6-31

6.5  LOW VOLUME EXEMPTION 	  6-36

    6.5.1  INSPECTION OBJECTIVES	  6-37
    6.5.2  INSPECTION GUIDELINES  	  6-39

6.6 RESEARCH & DEVELOPMENT EXEMPTION	  6-41

    6.6.1 INSPECTION OBJECTIVES	  6-42
    6.6.2 INSPECTION GUIDELINES	  6-42

6.7  TEST MARKETING EXEMPTION	  6-45

    6.7.1  INSPECTION OBJECTIVES	  6-45
    6.7.2 INSPECTION GUIDELINES	  6-48
TSCA fift 5/8 Inspection Guidance         6-i                       November 1992
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TSCA Section 5 Inspections	Chapter Six

                    TABLE OF CONTENTS (CONTINUED)

                                                                  Page

6.8  POLYMER EXEMPTION	  6-52

    6.8.1  INSPECTION OBJECTIVES	  6-55
    6.8.2  INSPECTION GUIDELINES 	  6-55

6.9  INSTANT FILM CHEMICAL EXEMPTION (IFCE)	  6-57

    6.9.1  INSPECTION OBJECTIVES	  6-57
    6.9.2  INSPECTION GUIDELINES 	  6-60

6.10 ZERO EXPOSURE	  0-64


                           LIST OF FIGURES

FIGURE 6-1 MANAGEMENT INFORMATION TRACKING SYSTEM (MTTS)
          DATABASE 	  6-13
FIGURE 6-2 EXAMPLE - FEDERAL REGISTER STATUS REPORT	  6-14
FIGURE 6-3 NOTICE OF COMMENCEMENT LISTING	  6-16
FIGURE6-4 SAMPLEPRODUCTTREE 	  6-17
FIGURE 6-5 MANUFACTURING OPERATION	  6-20
FIGURE 6-6 EXAMPLES OF TEST DATA	  6-21
FIGURE 6-7 SAMPLE SECTION 5(f) ORDER	  6-24
FIGURE 6-8 SAMPLE FEDERAL REGISTER NOTICE GRANTING TEST
          MARKETING EXEMPTION	  6-51


                            LIST OF TABLES

TABLE 6-1  CHEMICALS NOT SUBJECT TO PREMANUFACTURE NOTIFICATION ... 64
TABLE 6-2  SUBMISSION REQUIREMENTS  	 6-7
TABLE 6-3  PREMANUFACTURE NOTIFICATION (PMN)	6-9
TABLE 6-4  PERSONS REQUIRED TO SUBMIT A SIGNIFICANT NEW USE
          NOTICE (SNUN)  	  6-32
TABLE 6-5  PERSONS EXEMPT FROM THE SNUN REPORTING REQUIREMENTS ...  6-33
TABLE 6-6  LOW VOLUME EXEMPTION (LVE) 	  6-38
TABLE 6-7  RESEARCH AND DEVELOPMENT (R&D) EXEMPTION	  6-43
TABLE6-8  NOTIFICATIONOFRISKS-R&DEXEMPTION  	  6-45
TABLE 6-9  RECORDKEEPING-R&D EXEMPTION	  6-46
TABLE 6-10 TEST MARKETING EXEMPTION (TME) 	  647
TABLE6-11 POLYMER EXEMPTION (PE)	  6-54
TABLE 6-12 INSTANT FILM CHEMICAL EXEMPTION (IFCE)	  6-58
November 1992                       6-ii         TSCA 88 5/8 Inspection Guidance
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 Chapter Six	TSCA Section 5 Inspections
                           6.0  TSCA SECTION 5 INSPECTIONS

 6.1  INTRODUCTION
 This chapter contains background information and guidance  to  assist  the  inspector  in  conducting
 inspections under Toxic Substances Control Act (TSCA)  Section 5.  Specifically, this chapter covers
 inspections to determine compliance with the Premanufacture Notice (PMN) rule, Section 5(e)/5(f) orders,
 and significant new use rules (SNURs), including certain exemptions thereunder.  The inspector should
 keep in mind that throughout this chapter whenever the terms "chemical" or "chemical substance" are
 used they mean "any organic or inorganic  substance of a particular molecular identity, including any
 combination of such substances occurring  in whole or in part as a result of a chemical  reaction or
 occurring in  nature, and any  element or  uncombined radical," as defined  in TSCA Section 3(2).
 Exclusions from this definition can be found in Section 6.1.1 of this Chapter. Section 6.2 of this chapter
 covers chemicals that are subject to Premanufacture Notice (PMN) requirements  and how the inspector
 can determine if the firm manufacturing (or importing) the new chemical substance is complying with
 these requirements.   The inspector should note that the TSCA definition of "manufacture"  includes
 "import," and wherever this chapter refers to "manufacture," it follows that "import" is included in that
 reference. The chapter also covers inspections to determine compliance with Section 5(e)/5(f) orders and
 Significant New Use Rules (SNURs) for chemicals being manufactured or imported that are subject to
                   -m, -
 such orders and/or rules in Sections 6.3 and 6.4, respectively.

 If the firm is not complying with the PMN requirements (i.e., has not submitted a PMN) because the
chemical is being  manufactured or imported under an exemption, then  the inspector must determine if
that firm is complying with the  conditions of or meeting the criteria for the applicable exemption. The
guidelines for conducting  these exemption inspections  are  detailed  in  Sections 6.S (Low  Volume
Exemption), 6.6 (Research and Development Exemption), 6.7 (Test Marketing Exemption), 6.8 (Polymer
Exemption), 6.9 (Instant Film  Chemical Exemption), and 6.10 (Zero Exposure Exemption) of this
chapter.  The sequence of this chapter reflects the FY 1993 OPPTS inspection priorities which will be
included in the Regional Memoranda of Agreement.  These priorities are to inspect non-submitters of
PMNs, TSCA Section 5(e) orders, SNURs, and holders of Low Volume Exemptions. Throughout the
chapter, the inspector will find tips and examples to help explain how the regulations apply and how they
are interpreted. In addition, the tables found throughout the chapter provide summaries of the regulations
as a quick reference for the inspector. The  inspector should note that these summaries are not intended
TSCA 55 5/8 Inspection Guidance             6-1                               November 1992
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 TSCA Section 5 Inspections	Chapter Six
 to substitute Tor the regulations published in the Code of Federal Regulations (CFR) and the Federal
 Register, and the appropriate citations are thus included in the tables for the inspector's use.

 When an inspector is doing a TSCA Section S inspection, s/he is generally focusing on one or more
 chemicals.   The most appropriate way to approach the inspection is from a chronological perspective.
 This  means the inspector will examine the target chemical(s) by looking first at  the  research  and
 development (R&D) stage, next at the test marketing stage (if applicable), then at the PMN process, and
 finally at the production stage under a Section 5(e)/5(f) order (if applicable). The inspector should review
 the records in this sequence. In conjunction with a chronological study of the subject chemical and as
 the first activity in the inspection, the inspector should consider requesting the appropriate company
 official (probably the R&D Director,  Director of Manufacturing,  Chief  Operations Officer) make a
 chronological, technical presentation on one of the targeted chemicals.  The inspector should also note
 that TSCA  Section 8 inspections are often conducted in conjunction with TSCA Section 5 inspections,
 depending on the amount of time available.  For detailed information on  conducting TSCA Section 8
 inspections, the inspector should refer to Chapter 7.

 Finally, when interviewing company  employees during the inspection, the inspector may advise both the
 company management and the individuals) being interviewed that employee rights are protected under
 Section 23(a)(3) of TSCA. This section of TSCA states mat it is unlawful for a company or employer
 to discharge or otherwise discriminate against an employee who assists with or participates in any EPA
 action intended to ascertain compliance with TSCA.   If possible, employees  should be interviewed in
private; however, participation by company officials or their legal representatives is not restricted by the
statute or regulations.

Under TSCA Section 5, EPA reviews all  "new chemical substances" subject to PMN requirements prior
to their being manufactured or imported for a commercial purpose.  A  new chemical substance, as
defined in Section 3(2) of TSCA, is any chemical substance mat is not included on the TSCA Section 8(b)
Inventory.  A new chemical substance is also one that is not specifically excluded from regulation under
TSCA (e.g., pesticides, drugs, cosmetics).

The overall objectives of the TSCA Section 5 inspection program are to ensure that:
   •  Firms manufacturing new  TSCA  substances have complied with  PMN and  PMN exemption
      requirements.
November 1992                              6-2             TSCA $9 5/8 Inspection Guidance
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 Chapter Six	TSCA Section 5 Inspections
   •  Finns subject to TSCA Section 5(e) and Section S(f) orders, rules, or injunctions are complying
      with specific restrictions.
   •  Firms manufacturing chemicals in such a manner that they are subject to SNURs are complying
      with Significant New Use Notification (SNUN) requirements.
These objectives are discussed in detail in the appropriate sections of this Chapter.  Because of the
interrelationship between TSCA Section 5 and TSCA Section 8(b), several of the firm's Inventory of
Existing Chemical  Substances submissions should be checked during a TSCA Section 5 inspection to
ensure that all chemicals submitted for the Inventory were properly reported.

6.1.1  PMN EXCLUSIONS AND EXEMPTIONS
TSCA Section 3(2)(B) excludes from the definition of "chemical substances" any mixture; any pesticide
[as defined in the Federal  Insecticide, Fungicide, and Rodenticide Act (FIFRA)J when manufactured,
processed, 'or distributed in commerce for use as a pesticide; tobacco or any tobacco product; any source
material, special nuclear material, or byproduct material [as defined in the Atomic Energy Act (AEA)
of 1954 and regulations issued under the AEA]; and any food, food additive,-drug, cosmetic, or device
(as defined in Section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed,
or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

Chemical substances falling into any of the above categories are not regulated by TSCA, unless they are
designated specifically for a TSCA use.  For example, as a chemical moves through the manufacturing
process, its status (i.e., intended or not intended for use as a pesticide) can change. TSCA regulates raw
materials and inert ingredients until they become components of a pesticide. Then EPA considers them
to be subject to FIFRA.

Certain types of chemical substances not subject to  PMN requirements are summarized in Table 6-1.
Furthermore, there are other chemical substances  that do not have to  fulfill the PMN requirements
because they meet the definition of a PMN exemption.
TSCA Section 5(h) provides the authority to establish exemptions from the PMN requirements for
chemical substances subject to TSCA jurisdiction.   The following six types of exemptions have been
established:
   •  Low Volume Exemption (LVE)
TSCA 55 5/8 Inspection Guidance             6-3                              November 1992
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                           TABLE 6-1 CHEMICALS NOT SUBJECT TO PREMANUFACTURE NOTIFICATION
                                                                                                                                                I
             720.22(bXl)
48 PR 21745
May 13,1983
 New chemical
                      imported as put of an article.
              720.30(b)
48 PR 21745
May 13,1983
 Any mixture as defined in 720.3(u). This exclusion applies only to a mixture as a whole and not to
'any chemical substances which arc part of the mixture.
              720.30(e)
48 FR 21746
May 13. 1983
(as amended
51 FR 15101
April 22, 1986)
Any new chemical
                         manufactured solely for export if, when the substance is distributed in
                                                  commerce:
                                                  • The substance is labeled in accordance with TSCA §12(a)(l)(B).
                                                  • The manufacturer knows that the person to whom the substance is being distributed intends to
                                                    export it or process it solely for export as defined in 721 .3.                    '
              720.30(h)
48 FR 21746
May 13, 1983
 The chemical substances described below (720.30(h)), which have no commercial purpose separate
 from the substance, mixture, or article of which they are a part, are not subject to notification
 requirements.
              720.30(hXl)
48 FR 21746
May 13, 1983
 Any impurity.
              720.30(hX2)
48 FR 21746
May 13, 1983
 Any byproduct not used for commercial .purposes.
              720.30(bX3)
48 FR 21746
May 13, 1983
 Any chemical substance which results from a chemical reaction that occurs incidental to exposure of
 another chemical substance, mixture, or article to environmental factors.
I
              720.30(hX4)
48 FR 21746
May 13, 1983
 Any chemical substance which results from a chemical reaction that occurs incidental to storage or
 disposal of another chemical substance, mixture, or article.
   *        _. •	   •- -j	                              -
              720.30(hX5)
48 FR 21746
May 13, 1983
 Any chemical substance which results from a chemical reaction that occurs upon end use of another
 chemical substance, mixture, or article, and which is not itself manufactured or imported for
 distribution in commerce or for use as an intermediate.
-------
(A
00
            TABLE 6-1  CHEMICALS NOT SUBJECT TO PREMANUFACTURE NOTIFICATION (Continued)
g
 3.
720.30(h)(6)
              720.30(h)(7)
              720.30(h)(8)
              720.30(i)
48 FR 21746
May 13,  1983
                  48 FR 21746
                  May 13, 1983
                  48 FR 21746
                  May 13, 1983
                  51 FR 15102
                  April 22, 1986
                                                                       Chemical Identification
Any chemical substance which results from a chemical reaction that occurs upon use of curable
plastic or rubber molding compounds, inks, drying oil, metal finishing compounds, adhesives, or
paints, or any other chemical substance formed during the manufacture of an article destined for the
marketplace without further chemical change of the chemical substance except for those chemical
changes that occur as described elsewhere in this paragraph.
                     Any chemical substance which results from a chemical reaction that occurs when (i) a stabilizer,
                     colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer,  corrosion inhibitor,
                     antifoamer or defoamer, dispersant, precipitation inhibitor, binder, emulsifier, deemulsifter,
                     dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer,
                     sequesterant, coagulant, flocculent, fire retardant, lubricant, chelating agent,  or quality control
                     reagent functions as intended, or (ii) a chemical substance, which is intended solely to impart a
                     specific physicochemical characteristic, functions as intended.
                     Any non-isolated intermediate.
                     Any chemical substance which is manufactured solely for non-commercial R&D purposes (including
                     scientific experimentation, research, or analysis conducted by academic, government, or independent
                     not-for-profit research organizations), unless the activity is for eventual commercial purposes.
                                                                                                                                                       I
                                                                                                                                                       IP
f
I

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TSCA Section S Inspections	.	Chapter Six

   •  Research and Development (R&D) Exemption

   •  Test Marketing Exemption CTME)
   •  Polymer  Exemption (PE)
   •  Instant Film Chemical Exemption (IFCE)

   •  Zero Exposure Exemption.


These exemptions are discussed in detail in Sections 6.5 through 6.10 of this chapter. Summaries of the

submission requirements for the PMN and the PMN exemptions are contained in Table 6-2.


6.1.2 INSPECTION SITES

Generally, PMN and PMN exemption-related information can be found in four locations that are based
on the separate corporate functions. Therefore, TSCA Section S inspections may be rather inconvenient

to complete, as some inspections will  require inspectors  to visit or gather information at multiple
inspection sites.  The four sites where PMN  and  PMN exemption information can be found are as

follows:
      Production and/or import sitefa). This is the facility (or facilities) where a PMN chemical is being
      commercially produced (or imported); therefore, it will normally be the site identified on the PMN
      form (Part n; Section A; Item 1).  This site may also be the location where the test marketing
      chemical is produced or imported.  The PMN, TME, LVE, PE, or IFCE production or import
      records are usually kept at this site, and it represents the most important site to visit for review
      of such records.  The inspector verities production amounts and dates here.

      Submitting office. The submitting office represents the point of consolidation of regulatory efforts
      to develop and market a new chemical.  This location is often the corporate or division level
      headquarters of the company and is normally the location of the personnel identified on the PMN
      form (Part I; Section A; Items la, Ib, and often 2). R&D-related activities often take place at this
      location.  As much information as possible regarding the PMN or applicable exemption should
      be confirmed at the submitting office, particularly if chemical testing and/or production data can
      be brought together at this location for compliance review purposes.  If any  questions about the
      PMN or exemption-related data or records still remain, a followup inspection may be conducted
      at the R&D and/or production facilities.
            fflfflftY  The R&D facility is usually the site where the new TSCA chemical is being
      synthesized and identified and where its basic chemical and physical properties are determined.
      This site may be the same as that of the submitting office. However, the technical contact is often
      an individual closely associated with R&D (Part I; Section A; Item 2).  In general, the inspector
      should verify the technical  information of Parts I and in  of the PMN form at the R&D site,
      particularly the substantiation of the chemical  structure of the PMN chemical.  This usually
      requires verification by a chemist.  Therefore, non-chemist inspectors should collect spectral and
November 1992                              6-6            TSCA 9$ 5/8 Inspection Guidance
-------
                                     TABLE 6-2 SUBMISSION REQUIREMENTS
g
' *n*toe of N0tificall»a -l
'^* ^ ^"" ff v'^li^M?l^'
Premanufacture Notice
Research and Development
Exemption
Test Marketing Exemption
Low Volume Exemption
Polymer Exemption
Instant Film Chemical
Exemption
Significant New Use Notice
"Zero Exposure"
Exemption

720.40(a)
720.40(b)
720.102(b)
720.36(a)
720.38(a)
720.38(d)
720.38(e)
723.50{a)(2)
723.50(a)(2)
723/250(3(1}
723.250(f)
723.2SO(f)
723.175(i)
723.175(1)
721.25 r
" V "\ ' ' •>. 1 f ' ".,, T f '• " >* v ".''<-*-
• Notice: Use of standard PMN form (EPA Form No. 7710 - 25} is required
• Submit 90 days before commencement of manufacture or import
• Submit NOC on, or no later than, 30 days after the first day of commercial manufacture or
import • ' '
• No application or notice required
• Application: Use of standard PMN form is not required; a letter containing required information
is sufficient
• 45-day review period; submitter must await EPA approval before commencing manufacture
• NOC not required
• EPA may impose restrictions to ensure that the substance will not present a risk to health or the
environment. I
• Notice (of intent to manufacture): Use of standard PMN form is not required
• Submit 21 days before commencement of manufacture
• (Limited Premaoufacture) Notice: Use standard PMN form; manufacturer tmisl indicate clearly
on the form a claim for the PE and musl complete applicable portions of the form
• Submit 21 days prior to the date of manufacture
• NOC required within 30 days of manufacture
• Notice: Use of standard PMN form is not required
• Submit to EPA when manufacture begins
• Notice: Use of standard PMN form is required
• Submit 90 days before commencement of manufacture, import, or processing
• 90-day review period must expire before commencement of manufacture, import, or processing
i
• Application: EPA has never required manufacturers of non-isolated intermediates, to which this
exemption primarily applies, to apply for an exemption. Rather, under the PMN regulations,
EPA has granted a blanket exemption to all such manufactures.
                                                                                                     S?
                                                                                                     i

-------
 TSCA Section 5 Inspections	Chapter Six

      otheTdata for further review. If possible, the inspector should also compare these analytical data
      with ongoing production quality  control  data.  Byproducts and impurities, as well as their
      method(s) of detection, also require substantiation at the R&D site, as well as validation of
      associated analytical methods and associated detection limits. The inspector should also verify the
      completeness of test data submitted at the R&D site to the extent possible (Part II; Section B).

   •  Processing  site.  This site is where a PMN chemical or chemical subject to an exemption is
      formulated, made into articles, or otherwise transformed without undergoing further chemical
      reaction or  modification for commercial purposes. A processor may also represent the importer
      of record for chemicals received from outside the United States.  The site may or may not be
      controlled by the chemical manufacturer, as described in Part n of the PMN form. Except when
      an importer is being inspected for PMN compliance, this is the lowest priority facility to inspect
      of the four  described sites.
     PREMANUFACTURE NOTICE REQUIREMENTS

The PMN requirements apply to "new chemical substances" and to "significant new uses" of existing

chemical substances,  as determined by the promulgation of a SNUR under TSCA Section 5(a)(2)

(discussed in Section 6.10).  Under TSCA Section S(a)(l) and 40 CFR Part 720, manufacturers or

importers of new chemical substances are required to submit 90 days prior to manufacturing or importing

a PMN of their intention to conduct such activities, as well as any test data in their possession or control

or other data concerning the health and environmental effects of the new chemical substance that are

known to or  reasonably ascertainable by  the submitter, in accordance with 40 CFR §720.50.  The

requirements for PMN submissions are summarized in Table 6-2. A copy of the PMN form is included

in Appendix 8.


TSCA Section 5(d)(l) specifies the information that must be provided in PMNs. The specific regulatory

requirements that apply to  the PMN are  summarized  in Table 6-3.   The inspector must verify this

required information in her/his effort to detect and document possible TSCA violations.


6.2.1 INSPECTION OBJECTIVES

The objectives of an inspection to assess compliance with the PMN requirements are the following:


   •  To check the accuracy and technical content of a PMN submitted by a manufacturer or importer
      and mat no commercial manufacturing occurred before the end of the review period (Phase 1
      Inspection)
November 1992                              6-8            TSCA SS 5/8 Inspection Guidance
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ui
oe
vo
f
                                                  TABLE 6-3  PREMANUFACTURE NOTIFICATION
               Authority
              720.45
              720.45(a)(l)-(3)
              720.45(b)
              720.45(c)
              720.45(d)
              720.45(e)
              720.45(f)
              720.45(g)(l)
              720.45(g)(2)

              720.45(gX3)
              720.45(g)(4)
              720.45(g)(5)
              720.4S(h)
              720.50(a)-(b)
48 FR 21747-21748
May 13,1983

48 FR 21748
May 13, 1983
48 FR 21748
May 13, 1983
                               48 FR 21748
                               May 13,  1983
48 FR 21748
May 13, 1983
                                                   Notice must include:
                                                   • Chemical identification and structure
                                                   • Impurities
                                                   • Known synonyms or trade names
                                                   • Description of byproducts
                                                   • Estimated maximum production volume
                                                     - first year
                                                     - any 12-month period during first 3 years
                                                   • Description of intended category of use
For sites controlled by the submitter:

• Identity of sites
• Process description of each manufacture, processing, and use operation
• Worker exposure information
• Information on release of substance to the environment
                    For sites not controlled by the submitter:

                      Description of each type of processing and use operation
                      Identification of estimated number of processing or use sites
                      Identification of situations in which worker exposure and/or environmental release will occur
                      Number of workers exposed
                      Duration of worker exposure
                      Controls that limit worker exposure and environmental release
• Health and environmental effects test data in the submitter's possession or control, or known to or
  reasonably ascertainable by the submitter
-------
I
                                          TABLE 6-3 PREMANUFACTURE NOTIFICATION (Continued)
                                                  -VY<>\  i   /;  -""''
             720.50(d)

             720.50(d)(l)
             720.50(d)(2)
             720.50(d)(3)
48 FR 21749
May 13, 1983
Data that need not be submitted:

•  Data previously submitted to EPA
•  Efficacy data
•  Non-U.S. exposure data
             720.78
             720.78(a)(l)
             720.78(b)(2)
             720.78(b)(2)
             720.78(b)(2)
48 FR 21751
May 13, 1983
As amended by
51 FR 15102-15103
April 22, 1986
Recordkeeping:
PMN submitter must retain documentation of:

• Other data [720.50(b>] in the submitter's possession or control
• Production Volume for the first 3 years of production or import
•. Date of commencement of manufacture or import
• Information must be retained for 5 years from the date of commencement of manufacture or
  import                  '

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Chapter Six	TSCA Section 5 Inspections
   •  To identify firms manufacturing or importing a chemical that is not on the TSCA Section 8(b)
      Inventory (i.e., the TSCA Inventory) and is not covered by a PMN exemption, but for which the
      manufacturer or importer has not submitted a PMN (Phase 2 Inspection).
      PHASE 1 INSPECTION
When checking for compliance with the PMN, the inspector should review the PMN documents before
the inspection and verify the information contained in the PMN form at the inspection site by reviewing
company records, interviewing company employees, and touring the facility.

A complete PMN inspection will address the following aspects of the PMN:

   •  Chemical identification and structure
   •  PMN 90-day review date
   •  Notice of Commencement (NOQ date
   •  Impurities
   •  Byproducts
   •  Proposed volume of production
   •  Proposed categories of use
   •  Process description
   •  Worker exposure
   •  Release and disposal information
   •  Health and environmental effects testing data
   •  Pollution prevention and recycling (optional).

In order to conduct the PMN review effectively, the inspector should identify all of the names used by
the company for the subject  chemical (including R&D  designations) and the chemical's end  use
product(s).  These names include chemical names, common names, trade names, synonyms, proprietary
designations, in-house jargon, and acronyms.  This will ensure that the inspector is fully aware when
these references to the subject chemical occur in other records under review.  Some of these names may
be listed in the  PMN (Part  1; Section B; Item 4); other designations may be identified through
interviewing and  review of company records and research files.
TSCA ftg 5/8 Inspection Guidance            6-11                             November 1992
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TSCA Section 5 Inspections	Chapter Six

Confirming the accuracy of two dates is the most important element of the PMN inspection from a

compliance standpoint.  These two dates are the 90-day review date and the NOC date. The following

guidelines should assist the inspector in assessing compliance with the PMN requirements:
   •  Verifying chemical  identificat'Qfl flnd structure.  The manufacturer or importer must specify
      whether the chemical substance is a Class 1 or a Class 2 substance or a polymer.  The chemical
      name, the molecular formula,  the Chemical  Abstract  Service  (CAS)  Registry Number  (if
      available), and a structural diagram of the chemical substance are required on the PMN and the
      chemical identification and structure is verified by OPPT.  Therefore, the inspector will only
      check the Material Safety  Data Sheet (MSDS)  (if available), the chemical  composition  or
      formulation data, or the product literature to verify the chemical identity.

   *  Verifying the PMN 90-day review date.  The 90-day review period begins on the date the Office
      of Pollution Prevention, and Toxics (OPPT) Document Control Officer (DCO) receives the PMN.
      The inspector must confirm that the submitter has waited until the final day of the 90-day review
      period before beginning to manufacture or  import the new chemical substance. The inspector
      should note that the 90-day review period can be suspended so that "day 90" may not be 90 days
      after  the  submission's receipt.  The 90-day review date  for a PMN  can be found in the
      Management Information Tracking System (MTTS)  database (Figure 6-1) and the appropriate
      Federal Register Status Reports, which are issued on a monthly basis (Figure 6-2).  MTTS tracks
      the review status of PMNs and any associated correspondence about new chemicals. During the
      inspection, the inspector should verify production/import1 status of all batches  (or runs) of the
      PMN chemical under review from the first  synthesis (which may  be R&D) up through the first
      commercial production (or import) after the NOC.  The inspector will obtain  this information
      through the following methods:

      -  Interviews with company officials

      -  Review of research, production, batch, and business records.

      The inspector should verify these  records, which may  be available in a variety of forms,  by
      reviewing routine production, batch, inventory, and sales records for at least one year prior to die
      official 90-day review date.  Company batch records may be kept  by product, reactor vessel,
      and/or chronological sequence and should also be randomly checked for  evidence of any  early
      commercial production of the PMN chemical.   By reviewing purchasing, import,  duty,  or
      inventory  records,  the inspector should also verify, for compliance PMN chemicals that are
      imported.    The inspector  should  also  review  and  copy  sales  records  to  substantiate
      commercialization of a chemical if s/he suspects the facility has begun commercial manufacture
      before the end of die review period.  The inspector should  also verify that batches claimed by
      company personnel to be manufactured for the purposes of R&D were  in fact manufactured for
      such purposes.

      If a PMN under review has been formally withdrawn, the 90-day review period is terminated, and
      there  will  be no 90-day review date. In this case, no commercial  manufacture or import should
      have occurred, and any such commercial manufacture or import will be a violation of TSCA. The
      inspector should review company correspondence to  verify that the PMN has been withdrawn.
November 1992                              6-12            TSCA {ft 5/8 Inspection Guidance
-------
Chapter Six	TSCA Section 5 Inspections
                                     FIGURE 6-1


        MANAGEMENT INFORMATION TRACKING SYSTEM (MTTS) DATABASE


       •••••••••••                  PKN MASTER RECORD                  •••••••••••
       • NON-CBX •                 REPORT DATS:  07/10/92               • NON-CBI •
       *••••••••••                                                     •••••••••••
      PMM NUNBOI  ! P-91-110S                 PROGRAM MANAGE*: ASCI
      DAY RECEIVESt 8/11/91                  T2CH. INTEGRATORS
      EOT OP SCOTICS PERIOD: »/«/»!   "»- 9(S}2:tfOL!        PG!         OATl!
      INTEHXM STATUS!                                              AS OP:
      DISPOSITION! FOCUS DROP                                      AS OPs 7/1/91
      STATUS UPDATE REPORT PAGES  1899
      CHEMICAL NAME: OligoMTlc thiodi*tftyUn-bia-(9-dlMthoxyl-l,4-dlh
                     ydroyridian-3-earboiryllata), including ollgo»«n e
                                 • pyriditi
               ontaininq MM pyrldin* •oictlm from the partial
               oxidation of dihydropyridiit* •oiotios
SEMEUe NAMES  NO
          NAMES ••  CBX
          CRB CXTTs	     	                 STATES     	    	
                 IMPORTEDS   OOMESTXC                DATE S(C)  EXT. SIGNEDI
      STANDARD REVXEV DATES 	                     DAT! OP ENTORCEMENT:
      SUSPEND DAY XV REVXBV PROCESSs 0
      REVXEV DAYS 20
      DATE OP ROCl  2/4/92    NUMBER OP DAYS PAST REVXEV PERIOD MANUP. COHMs  149
      SUSPSVSXOMs             RESTART:                   DAYS !• SUSPENSION:  0
      EM for ATtmtion, ROM to switch    |      Captor* Off        |  Application
       «••••••••••                  pm MASTER BECTim                  •••»•••••••
       • NON-C8X •                                                     • NON-CBI •
       •••••••••*•                REPORT DATES  07/10/92               *••••••••••
      PHN NUMBER  S P-91-110S

      DATE VOUMTABjY CONTROLS AGREED TO:

                                   DATE VOLUNTARY CONTROLS ACTBED TO:
                                               1)
                                               2)
                                               3)
                                               4)
                                               9)
                            I

                                   SB TEST  DATES 1)
                                                  2)
                                                  3)
                                                  4)
                                                  9)
VOLUNTARY TEST TYPEI
BS TEST  TUBS  1
               2!
               a
               4
               s
TSCA 55 5/8 Inspection Guidance            6-13                             November 1992
-------
 TSCA Section 5 Inspections
                                                                                     Chapter Six
                                            FIGURE 6-2


                     EXAMPLE - FEDERAL REGISTER STATUS REPORT



                                   / VoL 57. No. 17 / Monday. January 27.1992 / NoHcn
                                                   SaptembeeaBd(o)
                                    PlOte far whtafctha nrtow poned h»
                                    been mpaniad Thorefata. the
                                    September 199! PMN Statue Report b
                                    being publUhed.
    Agency (EPA).
                           1901

                      Protection
                                Dtruion. OffteuofPaOaueul
                                Toot*.
          r Section S(d)(3| of tin Toxic
    SutMwace Conml Act fTSCAj requires
    EPA lo iutM • hit In KM Fodeml
    Rojalar eoch month lepoittng iht
                                Report tar SEPTEMBER 1NL
                     (PMNi)ud      PMN No.
V
•umpttoa raquMt pmdiag before Iht
Agtacy tad Uw PMNs ud tuaptton
rtqtmt* for which On mvtow ptriod bM
 xpirad lino pubUctttoo of ttw Utf
    ^ _____ .       ..lUaUtbtnporttar

     Noaconfidntial portou of UM PMNt
    •nd ncimpttaa nqaat may bt MM la
    to TSCA Pnfatte Dock* Office NfrCOM
    MthiaddnMbtlewbtiwMaliiA.   -
    and BOOB ud 1 PA nd 4 PA. Mbndiy
    ihMMflh Hbi^laM •• •!•• Mm m IM^B! ^-"" -• --- -
    mnragn nuMj. maiming Mfti npiUfljrii
    iptdfic PMN and mmptlon rtqaoM
    numbtf ihouM bo ion! to; DacuiBinl
    Praemiai Cntw (TS-TWV Offleo of
    Pollution Pttvcntton and Toxica.
    Envutmowatel Protection Afonjejr. 401 M
    St. SW. nt Ul« WMfetefMa DC
    204aa(2tt)38»-WlS.
                                poi-um
                                P9MV4
                                Pn-un
                                Pet-mi
                                P 91-1119
                                POI-U99
                                Pm-i3M
                                P9I-UO)
                                pet-Mot
                                P 91-1409
                                P 91-1410
                                P 91-1414
                                P 91-1419
                                P 91-148
                                P 91-14*
                                P 91-1491'
                                P9M49I
                                P 91-1441
                                P 91-1449
                                P 91-1409
                                P 01-1404
pti-i37i pn-tan
P9I-1I78 Pfll-Un
pn-in pti.mn
Pn-ua
Pffl-UV P
pn-un P
pn-tiH Pn-UM
PBi-uai Pai HBO
P n-t40i P tMM
  PM^UflV D M^tdMiI
  mi^imf W WI'^IW
P n-uiii P tMoa
PtVMU POI-MU
PH-Mtt PflMOB
P 01-449 Pfl-MM

pn-i«n
Pti-MH
m Ija^OL^M

Pti-ua Pti-iMt pm-i«s
P n-Mtf^P fl-IMi PH-I4W
P *M4lt* P flMm p M-M8I
        P
        PtV-MO*
        Pn-MM
  fl-OU Y
Aiaittance DMaion 09-790). Office of
Pollution Pnventtnand Toxtea,   -

EB-H. 401M St. SW. Waahioftoo. DC



monthly atatut report published la the *
federal Reojelai ea required under
•action S(dNl) of TSCA (90 Slot 2012 (18
U.S.C U04)). win Identify: (a| PMNa
received durtne September: (b) PMNa
received prortouaty oad •nil odtr
rwnew el the end of September (e)
PMNa for which dw nodce review
period hu ended drta« September (d)
                                                                                   P9I-10U
                                                                                   p ti-toir
                                                                                   pn-ian
                                                                                   pn-taa
                                                                           Pft-UM
                                                                           Ptt-ua
                                                                               p oi-ton
                                                                               Ptl-lOV
                                                                               Pfl-UMI
                                                                               PM-tMS
                                                                               Ptt-1001
                                                                               Ptl-lOB
                                                                               P91-10B7
                                                                               pti>ion
                                                                               pn-ion
                                                                               pet-ioat
                                                                               Pti-ian
                                                                               P 9I-1IU
                                                                               p ti-na
                                                                               Pti-im
                                                                               pti-un
                                                                               Ptl-UM
                                                                               Pti-iat
                                                                                       PM-OB»
                                                                                       pn-oon
                                                                                       pn-ons
                                                                                       Ptl-OMI
                                                                                       p n-ioio
                                                                                       p n-ioi4
                                                                                       p n-i«a
                                                                                       pn-tott
                                                                                       pn-ion
                                                                                       pn-ta»
                                                                                       pn-ioM
                                                Pti-tou
                                                P91-UM6
                                                pn-ioso
                                                PH-IOM
                                                Ptl'IOH
                                                P9I-10BI
                                                Pti-ioaB
                                                Pti-tora
                                                p n-ior«
                                                p n-nir
                                                r m-nn
                                                p n-tin
                                                Pfl-UM
                                                pai-tno
                                                pn-iiaa
November 1992
                                            6-14
                       TSCA 89 5/8 Inspection Guidance
-------
Chapter Six	TSCA Section 5 Inspections

   •   Verifying Notice of Commencement fNQQ daft  In accordance with 40 CFR §720.102(b), an
       NOC must  be submitted to the EPA on, or  within,  30 calendar  days  of the first day of
       manufacture or import of a PMN chemical that has passed the 90-day review period.

       PMNs approved prior to the effective date of the PMN rule (i.e., May 13, 1983) should have
       submitted NOCs by that date (or within 30 days). The inspector can find the NOC date on the
       Notice of Commencement Listing (Figure 6-3), which is prepared every six months and distributed
       to the Regions, or from company correspondence with EPA.

       The NOC phase of the PMN inspection will normally constitute an extension of the overall PMN
       production date review.  The date of first commercial production or import of a PMN chemical
       should be verified by reviewing company production or other records. The information from
       these records should then be compared  with the NOC date.

       A company  is in violation if it does not submit an NOC within 30 days of initial commercial
       manufacture or import of a PMN chemical. The company is also in violation if it has submitted
       an NOC and no commercial manufacture or import has actually been initiated by that date (i.e.,
       a false NOC).

       If records or dates do not definitely address whether specific batches of a PMN  chemical were
       produced before the 90-day review  date or more than 30 days prior to the NOC date, then the
       inspector should obtain a signed statement or letter from a knowledgeable corporate official stating
       the exact purpose, details of production, and disposition of any batch(es) in question.
                                         DEFINITIONS
         doss 1 chemical substance is a substance whose composition, except for impurities, can
         be represented by a definite chemical structural diagram.  Examples of such substances
         are 1,3 butadiene, benzene, and sodium chloride.

         Class 2 chemical substance is a substance whose composition cannot easily be represented
         by a definite structural diagram. Such substances are generally derived from natural
         sources or complex reactions.  Their composition may be complex, difficult to
         characterize, and variable. Examples are chlorinated naphthalene, the gfycerol monoester
         of hydrogenated cottonseed oil adds, or a reaction product of specified reactants.

         A polymer is a substance composed of molecules characterized by the regular or irregular
         repetition of one or more types of identical monomeric units. In most cases, the number of
         monomeric units is quite large and not precisely known.
      Verifying impurities.   The manufacturer or importer must list in the PMN the impurities
      anticipated in the chemical substance by name, CAS Registry Number, and weight percent of the
      total substance.  The inspector should review facility records to verify the impurities  in the
      chemical substance against the information provided in the PMN. Information on the impurities
      can generally be found in the quality control analyses or specifications for the product.  It may
      also be possible for the inspector to find out information about the impurities from the reactants
      and raw materials employed during the manufacturing process.  A sample product tree is shown
      in Figure 6-4.  The inspector should note that in this figure, raw materials  are coded as 10—
TSCA §5 5/8 Inspection Guidance            6-15                             November 1992
-------


Caae B


p-M-eaia
P-M-BBIB
P-M-SMl
P-M-MOI
P-M-B944
P-M-BM7
P-M-B99B
P-M-IBB9
p-M-iaia
P-M-IBII
p-M-iait
P-M-1417
P-M-MM
P-M-IAM
P-M-1747
P-M-I7A*
P-M-I77I
P-M-1799
P-M-tlAI
P-M-tlOl
P-M-MM
P-M-EM7
P-M-tllt
P-M-E179
P-M-tftO
p-o9-ana
p-09-atai
p-09-asst
P-B9-B1M
P-W-BM7
P-W-BMB
P-W-B1I7
P-M-MSB
P-OV-MM
P-a9-a§71
P-B9-B7B7
P-M-06S7
P-a9-M7t
P-M-BBT*
p-a9-aa79
p-at-aets
P-B9-II1I
P-M-BIW
P-TC-MB7
P-M-MM
P-M-B7BI
P-M-IIB*
Y-M-aMI



End of
PIM oovloM

aS/la/M
BB/IA/M
as/ia/M
M/tE/M
M/M/M
M/M/M
M/IE/M
M/I%/M
M/I4/M
M/I4/M
M/I4/M
M/tl/M
ta/ti/M
IB/II/M
IB/I9/M
la/ia/M
II/M/M
II/M/M
is/ta/M
It/EB/M
IE/EB/M
It/SB/M
It/tB/M
it/ta/M
II/E7/M
M/BB/B9
M/BB/09
M/M/09
M/I9/B9
M/I9/B9
M/E9/B9
M/n/at
as/n/aa
ai/ia/M
M/EB/09
«a/a7/at
B9/M/B9
•9/M/a*
ia/at/09
ia/at/a9
IB/B9/B9
IE/M/B9
at/ti/M
M/EO/M

•7/U/9*
oa/ii/M


FIGURE

NOC Data Ela
NO.

a*/at/aa
aa/ai/M
B7/BB/M
•7/t7/M
aa/ia/M
M/I9/M
at/M/a9
aa/iB/a9
aa/avaa
it/«s/a9
iE/aa/89
IB/IVM
IB/II/M
M/IB/B9
1E/B7/M
BC/IA/B9
II/IA/M
at/le/a9
BVI«/a9
avaa/M
Bt/19/09
BI/IA/B9
•l/lf/89
M/IS/B9
M/M/89
a7/lt/B9
07/it/a*
B7/IE/B9
B7/I9/B.9
aa/as/o*
B7/lt/B9
B9/IA/B9
•7/lt/a9
aa/as/M
It/ IB/89
M/ll/aa
at/CS/va
u/tt/09
u/tc/a9
ia/ia/M
ia/M/M
BI/M/M
M/IB/M
ai/at/9i
IB/B4/M
ia/M/M
u/aa/M
M/M/M

6-3

paod
of D

189
OB7
4a
M
7B
7*
119
Me
M
B19
•19
Bl
Bl
1*9
1*
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IB
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M
«M
M
It
M
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M
M
M
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74
IS*
•B
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14
IM
Bl
Bl
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M9
91
119
M9
IM
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•ai

NOTICE Of
NOTICE OF a
PLANT BITE
aya

CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
CA
orao«r
f COMMENCEMENT
naNCENENT INFORMATION
State PLANT
SITE
City
•LENDALE
•LEHDALE
TOMANCE
TOMANCE
SANTA FB SPRINBS
SANTA M SPRINGS
SOUTH SAN FRANCISCO
TOMANCC
lURRAnTl
TOMANCE
TOMANCE
•LENDALE
OLEHDALE
US ANKLES
TUSTIN
TOMANCE
•LENDALE
TOMANCE
TOMANE
OLENBALE
•LENDALE
•LENDALE
•LENDALE
TOMANCE
•LENDALE
TOMENCR
TOMENCC
TOMANCC
TOMANCE
TOMANCE
TOMANCE
TOMANCC
TMBANCE
TOMANCC
TOMANCC
•ANOIEOO
LOS ANKLES
LOS ANKLES
LOS ANKLES
TOMANCE
TOMANCC
US ANKLES
LOS ANKLES
TOMANCE
TOMANCC
TOMANCC
CLCNDALC
SAN MARCOS
ad by IrB/PDO/NCIH
LISTING
Iliia NEONfSDAV. FEBRUARY 11. 1991 IM
CO
Naoo

PRODUCTS RESEARCH A CHEMICAL CORPORATION
PRODUCTS RESEARCH A CHEMICAL CORPORATION
SHIN-ISTU SILICONES OF AMERICA. INC.
SHIN-ESTU SUICONES OF AMERICA. INC
PILOT CHEMICAL COMPANY
PIUT CHEMICAL COMPANY
THE O-MIEN CORPORATION
miN-ISTU SILICONES OF AMERICA. INC
SHIN-ESTU SILICONES OF AMERICA. IMC
Shln-Eatu Slllcenaa of Aoarlea. Ine.
SMIN-ESTU SILICONES OF AMERICA. INC
Producta Raaaarch a Chaaleal Corp.
Produeta Reaaerch • Choaloal Corp.
Oaical (U.S.A.). Ine.
Ricoh Electronic* Ine.
Shin-Eatu Siliconaa of Aoarlca. Ine.
Produete Raaaarch A Chaalcal Corporation
Shln-Eatu Sllleonao of aoarlea. Ine.
Bhln-Etau Sllioonaa of Aoorloa. Ine.
Produeta Raaaarch a Chaoleal Corporation
Producta •aaaareh • Chaaleal Corparotion
Producta Raaoareh A Chaoieal Corporation
Produeta Raaaarch a Chaoieal Corporation
Shln-Etau Slllconoa of Aoarlca
Produata Raoaarch A ehaoioal Corporation
Shln-Eatu Sllleenaa of Aoarlca Ine.
Shln-Etau aillconao of Aoarlea Ine.
Shin-Etau Sllieonaa of Aoorlca Ine.
Shln-Eatu Siliconaa of aoarlea Ine.
Shin-Etau Slliconea of Aoarlca Ine.
Shin-Etau Sllleenaa of Aoorlca Ine.
Shln-Eatu Sllloanao of Aoorlea Ine.
Shln-Eatu Sllleenaa of Aaarlaa Sna.
Shln-Etau Silleenoa of Aaariea Ine.
Shln-Etau Silleenao of Aooriea Ine.
Mori tax USA. Ino.
Paelfie Archor Chaoleal Corparotion
Paelfie Anchor Chaalcal Corporation
Paelfie Anchor Chaoieal Corporation
Shln-Etau Slllconoa of Aoorlca. Inc.
Shln-Etau Slllconea of Aoorloa. Ino.
Poelfie Anchor Choaleal Corporation
Pacific Anchor Chaaleal Corporation
Shln-Etau Si licence of Aoorlca. Ine.
Shln-Etau Sllleonaa of Aoorica
Shln-Etau Sllleonaa of Aoarlca. Ine.
Produeta Raaoareh • Chaaleal Corporation
NAPP SYSTEMS IMA). INC.

I
Sp
-------
 Chapter Six
                                        TSCA Section 5 Inspections
      Raw Material  10001
      Raw Material  10002
      Raw Material  10013
      Raw Material  10355
      Raw Material  10024
      Raw Material  1010C
      Raw Materi
      Raw Material  1000C
      Raw Material  1028!
      Raw Material  10164
31
      Raw Material  1035
      Raw Material  10121
      Raw Material  10019
       Raw Material  10389
                                     FIGURE 6-4
                               SAMPLE PRODUCT TREE
          Intennediate   20086
                                 Intermediate  20001
                                 Intermediate  20045
                                 Intennediate  20031
                                       Final Product  30061
TSCA H 5/8 Inspection Guidance
                   6-17
November 1992
-------
TSCA Section 5 Inspections	Chapter Six

      series, isolated intermediates as 20— series, and the final product as a 30— series.

   •  Verifying byproducts. Hie manufacturer or importer must include in the PMN any byproducts
      resulting from the manufacture, processing, use, and disposal of the new chemical substance. The
      inspector can generally find byproducts information in product files.  These product files may
      appear in various forms, such as a product diagram or tree that lists the raw materials, isolated
      intermediates, and byproducts.

   •  Verifying proposed volume of production.  The manufacturer or importer must include in the
      PMN an estimate of the maximum amount of the chemical to be manufactured or imported during
      the first year of production and the estimated maximum amount to be manufactured or imported
      during any 12-month period during the first three years of production.  The inspector should
      verify these production or import numbers by reviewing the production or import records for the
      first three  years of production  or import.  The inspector should document discrepancies in
      production  numbers.

   •  Verifiying proposed categories of use. The manufacturer or importer must describe the intended
      categories of use of the chemical substance by function and application in the PMN.  In addition,
      the manufacturer or  importer must include an estimate of the percent of production volume
      devoted to each category of use and the percentages of the new substance in the formulation for
      each commercial and consumer  use.  The  inspector must verify the categories of use through
      review of general production, inventory, and sales records.
                                         DEFINITIONS
         Function is related to the inherent physical and chemical properties of the substance
         (e.g.. degreaser, catafyst, plasticizer, ultraviolet absorber).

         Application refers to the use of the substance in particular processes or products (e.g., a
         degreaser may be used for cleaning of fabricated metal pans).
                                               TIPS
                      Examples of how the company may describe categories of use

               A disperse dye carrier for finishing polyester fibers
               A cross-tinting agent for epoxy-type coatings for metal surfaces
               A flame retardantfor surface application on cotton apparel, textile home
               furnishings, and exterior canvas products
               A surfactant in automobile spray wax
               A colorant for paper and other cellulosics
               Fiber-reactive dye for nylon carpeting and upholstery
               An antioxidant in fuel oils and lubricants.
November 1992                              6-18            TSCA }$ 5/8 Inspection Guidance
-------
Chapter Six _ TSCA Section 5 Inspections

   •   Verifying process description. For sites controlled by the manufacturer who submits a PMN, the
       notice must include a process description of each  manufacture, processing,  and use operation
       containing a diagram of the major unit operations and chemical conversions, the identity and entry
       pout of all feedstocks,  and the points of release of the chemical substance.  To verify the
       processes used to manufacture the subject chemical, the inspector should walk through the facility,
       inspecting every major unit process and the points of entry and release of the subject chemical and
       compare  the  manufacturing process  diagram  to  in-plant operations.   An  example of a
       manufacturing process diagram is presented in Figure 6-5.  Any discrepancies between what was
       provided in the PMN and the in-plant operations should be documented. If possible, the inspector
       should obtain  a signed statement from company officials explaining the discrepancy.

   •   Verifying worker exposure.  For sites controlled by the manufacturer, the PMN must supply
       worker exposure information including worker activities, the physical form of the new substance
       to which workers may be exposed, the number of workers, and the duration of the activities.  The
       inspector should review records documenting worker exposure information (e.g., monitoring
       records).  In addition, the inspector should tour the facility and interview employees to verify what
       tasks expose the workers to the  chemicals (e.g., changing reactor vessels, sampling for quality
       control, bulk loading, changing filters, cleaning equipment). At this time, the inspector should
       also verify the use of protective equipment and engineering  controls (e.g., gloves,  goggles,
       respirators, closed containment system).

   •   Verifying release and disposal information. For sites controlled by the manufacturer or processor,
       the PMN must include information  on the  release of the  new substance to the environment,
       including the quantity and media of release and the type of control technology used. The inspector
       should review records documenting the amount of chemical  substance released (e.g., monitoring
       records).   The inspector should note  any discrepancies greater than 20 percent between the
       quantity specified in the monitoring records and the estimate provided in the PMN regarding the •
       amount of chemical released.  During a tour of the facility, the inspector should examine the
       control  technologies in place as well  as the points of and types of release.
   •  Verifying health and CIlYirQlnniOtili fffefts testing data.  All health and environmental effects
      testing data in the possession or control of the manufacturer or importer, as well as descriptions
      of health and environmental effects testing data known to or reasonably ascertainable by the
      manufacturer or importer, must be submitted as part of the PMN. The inspector should review
      the files containing health and environmental  effects  testing data.  Examples of  test data are
      provided in Figure 6-6. The inspector should note any testing data that were not submitted with
      the PMN and should obtain copies and attach them to the inspection record. The inspector should
      confirm that the dates of such submitted data or information are reliably documented in order to
      verify that these critical data were generated or available prior to  the PMN submission.

   •  Verifying pollution prevention and recycling information (optional). If the company has provided
      information on any pollution prevention measures or recycling programs being implemented by
      the facility, the inspector may want to  discuss and review these measures and/or programs. This
      is an ideal opportunity for the inspector to praise the company's efforts in these areas and to
      provide any additional  pollution prevention outreach material being distributed by EPA.
TSCA 55 5/8 Inspection Guidance            6-19                               November 1992
-------
 TSCA Section 5 Inspections
                                                     Chapter Six
       Stannic
       ChiorUt —
       800 kg/batch
       cnlorMa
       200 kg/batch
       Tributyl
       aluminum
       900 kg/batch
j

      Toraeyeto
       Tht numbt
                                 FIGURE 6-5


                        MANUFACTURING OPERATION
                        Mix Tank
                                         Tank

                                        I
                        Column
                                        I
                                    NawChamtoal
                                 Subsume* Drumming
                                                 Into
                                           ^
                                                      orfugluVt
November 1992
                      6-20
TSCA » 5/8 Inspection Guidance
-------
Chapter Six
                                  TSCA Section S Inspections
                                           FIGURE 6-6

                                                OF TEST DATA
       Physical and Chemical
           Properties and
      Environmental Fate Data
 Health Effects Data
Environmental Effects
         Data
       Chromatograms
       Spectra (ultraviolet, visible,
       infrared)
       Density/relative density
       Solubility in water
       Melting temperature
       Boiling/sublimation
       temperature
       Softening point
       Vapor pressure
       Dissociation constant
       Particle size distribution
       Octanol/water partition
       coefficient
       Henry's law constant *
       Volatilization from water
       Volatilization from soil
       PH
       Flammability
       Explodability
       Adsorption/desorpa'on
       characteristics
       Photochemical degradation
       Viscosity
       Odor
       Hydrolysis
       Thermal analysis
       Chemical analysis
       Chemical oxidation
       Chemical reduction
       Biodegradation
       Transformation to persistent
       or toxic products
Mutageniciry
Carcinogenicity
Teratogenicity
Neurotoxicity/behavioral
effects
Pharmacological effects
Mammalian absorption
Distribution
Metabolism and excretion
Cumulative, additive and
synergistic effects
Acute, subchronic and
chronic effects
Structure/activity
relationships
Epidemiology
Reproductive effects
Clinical studies
Dennatoxicity
Phototoxicity
Irritation
Sensitization
Allergy
Skin staining
Microbial bioassay
Algal bioassay
Aquatic macrophyte
bioassay
Seed germination and root
elongation
Seedling growth inhibition
Plant uptake
Acute toxicity to
invertebrates
Life cycle test on
invertebrates
Acute toxicity to fish
Early life stage (fish)
Avian dietary/reproduction
Bioaccumulation/
bioconcentration
Model ecosystem studies
Physical environment
impairment effects
Flesh staining of aquatic
organisms
TSCA H 5/8 Inspection Guidance
          6-21
                November 1992
-------
 TSCA Section 5 Inspections	Chapter Six
 6.2.3  PHASE 2 INSPECTION
 To determine whether die manufacturer or importer has failed to submit the required PMN, the inspector
 should first compare the list of chemicals, isolated intermediates, and raw materials currently being
 manufactured, imported, or used by the company against the TSCA Inventory.
 Before the inspection, the inspector should ask company officials to prepare a list of chemicals,  isolated
 intermediates, and raw materials they currently manufacture, import, or use. The listing should contain
 the chemical name, CAS Registry Numbers, and trade name(s) for each chemical being manufactured or
 imported. The inspector should note that although the company is not required to prepare such a list for
 the inspection, the company should be encouraged  to do so to facilitate the inspection process (discussed
 in Section 3.3.2).

 The inspector should verify the accuracy and completeness of this list by reviewing inventory, production,
 batch, and sales records for the most recent 5 years. Any chemicals identified in these records mat are
 not on the list prepared by the company should be  documented, and the inspector should ask the facility
 officials to explain the deviation.  The total production for the previous S years should be documented
 for any chemical potentially in violation of TSCA because the manufacturer or importer failed to submit
 a PMN.  In addition, die inspector should document the customers who have received this chemical and
 the use of the chemical.

 Once the inspector has verified the accuracy of this list, the inspector must determine if the chemicals are
on the TSCA Inventory (bom open and confidential sections).  The CAS Registry Numbers are  very
 important because these designations are the easiest way to verify a chemical's presence on the Inventory.
This can be done through an Enforcement Request to Headquarters (see Section 3.2.4) or if the Region
has on-line access to CUS.  The inspector can use the Chemicals in Commerce Information System
 (CICIS) database to determine automatically if the chemicals are on the open Inventory.  The  EPA
Regulated Chemicals System, which consists of the open Inventory and the Chemicals on Reporting Rules
 (CORR) database, is currently being developed and could be used by the inspector. If the chemicals are
not on the open Inventory, the inspector must search the closed, or confidential, section of the Inventory.
If possible, the inspector should obtain the chemical structures) of any chemical(s) not found on the open
 Inventory from the facility.  If the inspector discovers that a  particular raw material used, but not
 manufactured, by the company is not on the Inventory, s/he should document die supplier and die  steps
 taken by die company to comply wim TSCA.  After die inspection, die inspector should request that die
November 1992                              6-22            TSCA $5 5/8 Inspection Guidance
-------
Chapter Six	TSCA Section 5 Inspections
Information Management Division (IMD) of OPPT conduct a search of the confidential section of the
Inventory. Procedures for requesting this search are contained in Appendix 2.

63 TSCA SECTION 5(e)/5(f) ORDER
EPA can prevent or restrict the manufacturer of a new chemical substance at the end of the 90-day review
period by means of a TSCA Section S(e)/5(f)  order. TSCA Section S(e) orders are issued by EPA to
provide restrictions mat will minimize human  exposure and/or environmental release when insufficient
information is available to evaluate fully  the potential hazards associated  with  a PMN chemical.
Generally, a TSCA Section S(e) order is issued  based on structure-activity relationship, similarity to other
known hazardous chemicals, and/or potential for significant exposure or release. To issue a Section S(e)
order, EPA must find (1) that available information is insufficient to permit a reasoned evaluation of the
health and environmental effects of the new chemical  substance, and either (2) that the substance may
present an unreasonable risk to human health  and the environment (a "risk-based" finding), or (3)  that
the substance will be produced in substantial quantities and may entail substantial environmental releases
or significant or substantial human exposures.  A TSCA Section S(f) order is similar to the Section 5(e) -
order, except that  sufficient data  already exist to  confirm an  unreasonable  risk associated with the
chemical.  A sample Section 5(f) order is shown in Figure 6-7.

If EPA is considering taking action under Section 5(e)/5(f), EPA will first request mat the submitter of
the PMN volunteer to suspend the 90-day  review period  in order to allow EPA time to develop the
appropriate regulatory action. If the submitter  is unwilling to cooperate, EPA can unilaterally extend the
review period for "good cause" for up to 90 additional days.

EPA must propose a unilateral TSCA Section S(e) order at least 45 days before the expiration of the
review period, and the order becomes effective on the 91st day. A manufacturer subject to an impending
TSCA Section S(e) order has these three choices: (1) challenge the unilateral order;  (2) negotiate a
consent order; or (3) withdraw the PMN.  Although TSCA Section 5(e) does not explicitly authorize EPA
to enter into consent orders, EPA has employed this compromise mechanism to enable the  manufacturer
to proceed with planned operations while complying with certain EPA-imposed restrictions delineated in
the order.
TSCA 99 5/8 Inspection Guidance            6-23                              November 1992
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TSCA Section 5 Inspections
                                                                                         Chapter Six
                                         FIGURE 6-7


                             SAMPLE SECTION 5(0 ORDER


                         / Vol 4fc Na.ua / -ttBreday. Jaa» *
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                                                                                             ^
                                                                 ftetiploflhitpplteilteBUHhiFodoMl
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November 1992
                                                  6-24
                                                                TSCA 9} 5/8 Inspection Guidance
-------
 Chapter Six	TSCA Section S Inspections
 There are many TSCA Section S(e) orders and some TSCA Section 5(0 orders in effect for chemicals
 for which commercial production has not been initiated and an NOC has not been submitted to EPA.
 If no NOC is recorded as filed, a TSCA Section 5(e)/5(f) inspection will normally not be conducted.

 When conducting the TSCA Section S(e)/S(f) order inspection, the inspector must ensure that s/he has
 a copy of the final version of any TSCA Section 5(e)/5(f) order, not a draft version that may have been
 prepared by EPA officials for negotiating purposes.  The inspector should also check whether the order
 has been modified subsequent to its issuance.

 6.3.1 INSPECTION OBJECTIVES
 Before the inspection, the inspector should review copies  of the final  TSCA Section 5(e)/5(f) order,
 injunction, or rule and associated PMN(s), as well as copies of correspondence with EPA regarding the
 TSCA Section 5(e)/5(f) order,  injunction, or rule.  At the plant site, the inspector should verify the
 information contained  in these documents  by reviewing company records, interviewing company
 employees, and touring the facility. The inspection determines compliance with a TSCA Section 5(e)/5(f)
 order by verifying adherence to the constraints placed on the manufacturer by the TSCA Section S(e)/S(f)
 order.

 6.3.2 INSPECTION GUIDELINES
 Most TSCA Section 5(e)/5(f) orders include, but are not limited to, the following elements:

   •  Testing trigger
   •  Permeability testing
   •  Personal protective equipment and environmental release controls
   •  Employee training
   •  Disposal
   •  Labeling
   •  Customer notification and compliance.

A TSCA Section 5(e)/5(f) order inspection will be most productive if the subject chemical  is actually
being manufactured or processed at the time of the inspection (i.e., so that the use of required protective
TSCA 8* 5/8 Inspection Guidance            6-25                              November 1992
-------
 TSCA Section 5 Inspections	Chapter Six

 equipment and controls can be fully evaluated).  Therefore, the inspector should attempt to arrange the

 inspection during such activities.
       Verifying testing trigger. Some TSCA Section 5(e) orders require "testing triggers."  If a certain
       aggregate production (or import) volume of the subject PMN chemical is reached (i.e.,  the "testing
       trigger"), then the company must curtail manufacture until the test data have been submitted. Test
       triggers are usually expressed in terms of production volume, but some orders also  express the
       trigger in  terms of time (e.g., "20,000 kilograms or one  year after the  commencement of
       commercial manufacture, whichever is later").  Testing may be to determine health effects,
       environmental effects, chemical fate, physical fate, or all four.  When  EPA  believes that a risk
       may be adequately mitigated through employment of human exposure and/or environmental release
       controls pending the development of adequate toxicity  data, it will permit manufacturers to
       commence commercial production and submit the data by a given production volume.

       The inspector must establish total production and/or import  volume for the PMN chemical of
       interest and determine whether the specified testing trigger volume has  been  attained or not.  If
       the figure was  reached, then the inspector will  need to verify that  the company submitted
       information within a certain time period of reaching that specified volume.  That determination
       may depend on  the language in the consent order. The  inspector may also  need to verify that
       specified  testing had been initiated by  the  company if  future manufacture or import was
       anticipated.  The initiation or completion of testing should be documented,  including the
       identification of the testing laboratory or laboratories and the anticipated starting and  completion
       dates.  A determination of whether the tests are being conducted according to the Good  Laboratory
       Practice  (GLP)  Standards  regulations  will not be made during the TSCA Section 5(e)/5(f)
       inspection, but during a GLP inspection conducted by OCM.

       If testing has been, initiated, the inspector should also ascertain, whether any  preliminary and/or
       final reports have been received by the company  from the testing laboratory and whether the
       reports have been submitted to the EPA. Unsubmitted reports should be reviewed (and copies
       taken as exhibits, if necessary) to determine if there was a potential TSCA Section 8(e) substantial
       risk violation (discussed in Chapter 7).

       Verifying permeability testing.  Many TSCA Section 5(e)/5(f) orders contain a requirement that
       the company or facility test and/or evaluate chemical protective clothing for imperviousness to the
       PMN chemical.   The scope of this testing has been put forth as an updated EPA Inspection
       Guideline, dated May 1985 (included in Appendix  9).

       The inspector should document if, when, and by whom such testing/evaluation was performed and
       whether  it  was  conducted according to the  EPA criteria.   A copy  of the permeability
       testing/evaluation report or summary  for the PMN chemical should be collected and attached to
       die inspection report.

       The inspector should also verify and document, if necessary, that employees use protective gloves
       during production, handling, transfer, and/or processing of the chemical in question, and that the
       gloves are identical or have been determined to be  equivalent to those tested for imperviousness.
       The inspector should interview employees to verify the use of gloves, and s/he should also look
       at company purchase orders to determine whether the company is buying enough gloves for its
       employees.
November 1992                               6-26            TSCA $9 5/8 Inspection Guidance
-------
Chapter Six                  	TSCA Section 5 Inspections

   •   Verifying personal protective equipment and environmental release controls. Many TSCA Section
       5(e)/5(f) orders carry a requirement that certain protective equipment be worn by  workers and
       other personnel coming into contact with the PMN chemical and/or that environmental release
       controls on production-related equipment be employed.  A key aspect of the TSCA Section
       S(e)/5(f) order inspection will be to determine if these protective and/or safety measures have been
       established and are in active (and effective) use during the production and other handling of the
       PMN chemical(s). The inspector should recognize that the generic TSCA Section S(e) language
       refers to the Occupational Safety and  Health Administration (OSHA) requirements listed at  19
       CFR Part 1200.   However, any violations  of these requirements  found by die inspector are
       violations of the consent order, not  of OSHA because they are' pan -of the  consent order
       requirements.

       To determine effectively die compliance with this aspect of a TSCA Section 5(e)/5(f)  order, the
       inspector should attempt to conduct the inspection when the subject PMN material is actually being
       manufactured (or processed, in the case of imports).  The inspector can directly observe the use
       of personal protective equipment and controls and can document noncompliance accordingly.  If
       me new chemical substance has  been manufactured  or processed, but not during the on site
       inspection, the inspector should interview employees (and others, if necessary) to determine if the
       required equipment and controls  are being used.

       If protective equipment is not being (or has  not been) worn, as required by the  TSCA Section
       5(e)/5(f) order, then the inspector will need to determine if:

       -  The  clothing and equipment have not been made available (along with training).

       -  The  clothing and equipment have been made available, but are not being used.

       -  The  clothing and equipment have been supplied, but proper training for their use has not been
         provided.

       -  The  clothing and equipment have been supplied, but they have not been properly maintained.

       If any of these three situations are found to be the case during die inspection, die inspector should
       attempt to obtain a signed statement from  die employee(s), or alternatively obtain a signed
       statement from a responsible management official documenting the situation. If a second member
       of the inspection  team is present and a signed statement cannot be obtained, the employee's or
       manager's interview responses should  be noted in the field notebook, signed by die interviewing
       inspector, and signed by the second team member  as witness.

       The inspector  should document with photographs  (if possible) or  signed statements from
       knowledgeable or responsible individuals a lack of protective equipment or employment of
       engineering practices contrary to the TSCA Section S(e)/S(f) order.

   •   Verifying employee training  Most TSCA Section 5(e)/5(f) orders specify training in the handling
       of the subject PMN substance(s), as well as the use of protective doming and  devices.  This
       training is to be provided at die time of each employee's initial  assignment to  a  work area
       containing the substance and whenever die PMN substance is  introduced into die employee's work
       area for the first time.
TSCA 9$ 5/8 Inspection Guidance            6-27                              November 1992
-------
 TSCA Section 5 Inspections _ Chapter Six

       If the company has provided training in the handling of a PMN chemical subject to a TSCA
       Section 5(e)/5(f) order, the inspector should review a prospectus of the training and a list of the
       employees who attended the course (i.e., a "sign-in" sheet). The inspector should verify that the
       scope of the training corresponds with the TSCA Section 5(e)/5(f) order requirements, and s/he
       should check that the list of attendees corroborates the list of employees  required to take the
       training course; verification can be achieved through employee and management interviews. The
       inspector should substantiate any commercial production of the subject chemical that has taken
       place prior to the date of the training session with dated copies of documents related to the
       training, as well as with documentation of the first date of commercial production.

       If the TSCA Section 5(e) order refers to the OSHA requirements fisted at 19 CFR Part 1200 then
       the employees  must also be trained  to be knowledgeable of and to implement the  OSHA
       requirements.  However, any violations of these training requirements found by the  inspector are
       violations of the consent order, not of OSHA.

   •   Verifying disposal. If the TSCA Section S(e)/5(f) order contains requirements for the disposal of
       waste, excess, and/or unsold chemical,  then the inspector should determine how all wastes for the
       subject PMN chemical are being disposed.  The inspector should fully document any disposal that
       was inconsistent with the  order is  to be fully documented with copies of invoices, manifests,
       correspondence, bills of lading, receipts, or other records.  The inspector should also document
       fugitive emissions and/or other uncontrolled waste releases.

   »   Verifying labels  and  MSDSs.  The TSCA Section  5(e)/5(f)  order will  normally contain  a
       requirement for MSDSs and labels for the subject PMN chemical, advising workers and customers
       of the potential health and/or environmental hazard  associated with the chemical and of the
       precautionary measures that should be taken when handling the chemical.

       The inspector should examine the labeling for  all shipments of the subject chemical(s)  sent to
       customers, particularly those ready for shipment. To document any non-compliance of labeling
       with the TSCA Section 5(e)/5(f) order requirements, the inspector should obtain bin  labels,
       photographs of actual labels of materials released for shipment, and copies of correspondence and
       shipping records.  The inspector should also obtain written statements from company officials
       and/or shipping personnel, if needed.
   •  Verifying customer notification and f9mf?l'fl1ffl  TSCA Section 5(e)/S(f) orders may also contain
      requirements that customers or other processors of the associated PMN chemical(s) are to be
      notified that the substance is the subject of a TSCA Section 5(e)/5(f) order and that they should
      take certain precautions when handling the chemical.  In older orders, this notification normally
      will consist of a form letter, which must be transmitted to a customer via return receipt mail prior
      to the first shipment of the chemical.  In most orders issued after 1988, manufacturers are required
      to convey safety information via an MSDS accompanying the customer's first shipment of the
      PMN substance. Consent orders require distributors to send to the company (i.e., die signatory)
      prior to distribution, a statement that they will adhere to the same restrictions as contained in the
      order.  The company must keep records that document the fulfillment of this obligation. The
      inspector should verify mat for all commercial  shipments of the PMN chemicals subject to the
      TSCA Section 5(e)/5(f) order, the customer has  been notified by copying the information that the
      company sent to customers and by checking for records of communication with customers about
      company directives to take certain steps.  If the company did not meet this requirement, the
      inspector should obtain written statements from company officials as to whether they were aware
November 1992                              6-28            TSCA ftft 5/8 Inspection Guidance
-------
 Chapter Six	TSCA Section 5 Inspections
       of the requirement and/or why they did not follow it. The inspector should document that no one
       received notification, if that is the case. If the inspector has reason to believe that the customer
       or processor was not adequately informed and/or is not complying with handling restrictions, the
       inspector may want to consider a secondary inspection (i.e., of the customer or processor).

 6.4  SIGNIFICANT NEW USE RULE
 6.4.1  RULE-MAKING  PROCEDURES
 SNUR requirements are found at 40 CFR Part 721 and consist of the following five subparts:

   •   Subpart A defines the terms found in other subparts
   •   Subpart B lists standardized significant new uses that EPA can apply to any existing chemical by
       rule
   •   Subpart C  establishes recordkeeping  requirements that EPA can impose upon manufacturers,
       importers, or processors
   •   Subpart D establishes expedited rule-making procedures that EPA can use to establish SNURs for
       chemical substances that have completed PMN review, limits the circumstances under which EPA
       can use these procedures to promulgate SNURs on chemicals that were not the subject of TSCA
       Section S(e) orders, and creates a procedure by which persons affected by an expedited SNUR can
       petition EPA to modify or revoke it
   •   Subpart E lists the chemicals that are subject to 40 CFR Part 721 and the new uses for each
       chemical that EPA has designated as "significant."
 EPA may use Subpart D's expedited procedures to promulgate a SNUR  by publishing a single notice in
 the Federal Register that  lists all the standard significant new uses that correspond to the restrictions in
 a particular TSCA Section S(e)  consent order.  When the SNUR is promulgated, any subsequent
 manufacturers (or processors) bf the chemical substance must either abide by the  restrictions of the
consent order or terminate operations and submit a Significant New Use Notice (SNUN) (See Section
6.4.2). In the course of EPA's review  of the SNUN, it may investigate any manufacture or processing
of the chemical that is not in compliance with the terms of the consent order and the SNUR. EPA may
also address other TSCA Section 5(e) consent orders applicable to these new uses. In addition, EPA can
use the expedited SNUR procedures to  regulate any chemical that completed the PMN process but was
not subject to a TSCA Section 5(e) consent order, provided the chemical meets  the "concern criteria"
listed in Subpart D. These criteria apply to chemicals of suspect toxicity and to chemicals structurally
similar to toxic chemicals.
TSCA 55 5/8 Inspection Guidance            6-29                              November 1992
-------
 TSCA Section 5 Inspections	Chapter Six
 6.4.2  SNUN REQUIREMENTS
 Although EPA  may have already placed a chemical substance on the TSCA Inventory, the original
 manufacturer or another manufacturer may use the chemical in a different way that could substantially
 increase human or environmental exposure to the chemical.
The SNUR essentially converts an "existing" chemical  into a "new" chemical  with  regard to the
designated significant new use.  A SNUR applies to a broader spectrum of submitters, than the PMN
regulations because it can apply to processors as well as to manufacturers and importers,  and it can
require everyone to whom the SNUR applies to file a SNUN, not just the first manufacturer or importer
of the chemical substance, as is the case with the PMN. In accordance with 40 CFR Part 721,  when EPA
issues a SNUR (see Section 6.4.1), manufacturers and processors of the subject chemical substance must
give 90 days prior  notice to EPA in the form of a SNUN.  The SNUN is the functional equivalent of a
PMN,  and information required in a SNUN mirrors the information that must be submitted b a PMN.
Any manufacturer or processor submitting a SNUN shall not manufacture or process a chemical substance
for a significant new use until the notice review period, including all extensions and suspensions, has
expired. EPA will process the SNUN in the same manner as it processes a PMN, unless such procedures
are inconsistent with 40 CFR Part 721.

Any manufacturer  or processor subject to  a SNUR must retain documentation of the information
contained in the SNUN for 5 yean from the date of its submission. Failure to keep any of these records
constitutes a violation of 40 CFR §721.40. When the inspector is arranging an inspection involving a
SNUN, s/he should ask the company to consolidate the supporting records prior to the inspection. The
records of each manufacturer or processor of a chemical  substance for a significant new use should
include the following:

   •   Documentation of the information in any SNUN. This information must be kept for five years.
   •   Any other records required by the terms in individual rules.

The inspector should not simply accept the records provided at the facility. S/he should become familiar
with other names and designations for the chemical substance and look for mention of the substance in
any other records and data reviews, as well as watch for its potentially illegal manufacture, sale, storage,
or use  during the inspection.
November 1992                             6-30            TSCA 55 5/8 Inspection Guidance
-------
Chapter Six	TSCA Section 5 Inspections
6.4 J INSPECTION OBJECTIVES
When conducting a SNUR inspection, the inspector's objectives are as follows:
   •  For a Section S(e) order SNUR,  identifying that a facility is not in compliance with a TSCA
      Section 5(e) order because it is manufacturing or processing a chemical substance in a way that
      is considered to be a new use and  it had not submitted the required SNUN
   •  Checking the accuracy and technical content  of a  SNUN submitted by  a manufacturer  or
      processor.
In the first situation, to determine if a manufacturer or processor is manufacturing or processing in such
a manner that it would be considered a significant new use, the inspector should first check the list of
chemicals manufactured or processed by the facility to ascertain if any of these chemicals are listed in
40 CFR 721 Subpart E (i.e., Significant New Uses for Specific Chemicals).  Before the inspection, the
inspector should have asked company officials to prepare a list of the chemicals, isolated intermediates,
and raw materials they currently manufacture or import.  The listing should contain the chemical name,
trade name
-------
                                   TABLE 6-4 PERSONS REQUIRED TO SUBMIT A SIGNIFICANT NEW USE NOTICE
                                                 ttoi*
               721.5
                   53 PR 28359
                   July 27. 1988
                       The following persons must submit a Significant New Use Notice (SNUN):
               721.5(«KD


               721.5(a)(2)
               721.5(a)(2Xi)
               721.5(.)(2Xii)
               721.5(aM2Xiii)
 53 FR 28359
.July 27, 1988
                                          • A person who intends to manufacture, import, or process for commercial purposes a chemical substance
                                            identified in Subpart E and who intends to engage in a significant new use of that substance

                                          • A person who intends to manufacture, import, or process for commercial purposes a chemical substance
                                            identified in Subpart E and who intends to distribute the substance in commerce; person not required to submit
                                            SNUN if he can document one or more of the following about the recipient:
                                            (1) he has notified the recipient in writing of the appropriate section in Subpart E;
                                            (2) the recipient has knowledge of the section in Subpart E; or
                                            (3) me recipient cannot undertake any significant new use described in the section in Subpart E
               721.5(b)
                   53 FR 28359
                   July 27. 1988
                       • The person [721.5(a)(2)] who has knowledge at the time of commercial distribution of the substance identified
                         in Subpart E that a recipient intends to engage in a significant new use without submitting a SNUN
to
721.5(c)

721.5(c)(l)
721.5(c)(2)
                                  53 FR 28359
                                  July 27, 1988
                       • A person who processes a chemical substance identified in Subpart E must submit a SNUN unless he can
                         document that:
                         (1)  the person does not know the specific chemical identity of the substance being processed; and
                         (2)  the person is processing the chemical substance without knowledge mat the substance is identified in
                             Subpart E	
               721.5(d)(l)


               721.5(d)(lXi)

               721.5(d)(lXi>)
               721.5] who has knowledge that the recipient is
                         engaging in a significant new use without submitting a SNUN must cease distribution and submit a SNUN,
                         unless he can document that:
                         (1)  the person has notified the recqrient and EPA in writing within 15 working days of learning of the
                             recipient's lack of a SNUN;
                         (2)  within 15 working days of notifying the recipient, the person received a written statement of assurance of
                             me recqrient's awareness of terms in Subpart E and a promise not to engage, in me significant new use;
                             and
                         (3)  the person promptly provided EPA with a copy of the recipient's statement

                       • A person who manufactures, imports, or processes and then distributes to a recipient a chemical substance
                         used by the recipient for a significant new use without a SNUN ev?n after the recipient provided statements of
                         assurance to me contrary; mis person must cease distribution and then submit a SNUN

                       • The recipient described above.

-------
                                TABLE 6-5  PERSONS EXEMPT FROM THE SNUN REPORTING REQUIREMENTS
 r
1
              721.45
              721.45 (a)
              721.45(b)

              721.4S(c)
              721.4S(d)
              721.45(e)
              721.45(0

              72l.4S(h)
              72l.45(hXl)

              721.45(h)(2)
              721.45(i)
S3 PR 28361
July 27, 1988
f
The persons identified in 721.5 are not required to submit a SNUN for * chemical substance
identified in Subpart E if:

•  A person has been granted a test marketing exemption
*  A person manufactures, imports, or processes the chemical substance only in small quantities
   forR&D
•  A person has been granted an exemption under TSCA Section 5(h)(5) - "zero exposure*
   exemption
•  A person manufactures, imports, or processes the chemical substance only as an impurity
•  A person manufactures, imports, or processes the chemical substance only as a byproduct
   which is used only by public or private organizations that bum it as a fuel, dispose of it as a
   waste, or extract component substances from it for commercial purposes
•  A person imports or processes the chemical substance as part of an article
•  A person manufactures or processes the chemical substance solely for export and, when
   distributing the substance in commerce, labels the substance accordingly
•  A person submits a SNUN prior to the promulgation date of the relevant section in Subpart E,
   which identifies the chemical substance, and the person receives written notification of
   compliance from EPA prior to the effective date of the section if one of the following occurs:
   (1)  EPA is unable to make the finding that the activities described in the SNUN will or may
       not present unreasonable risk of injury to health or the environment under reasonably
       foreseeable circumstances; or
   (2)  EPA and the person negotiate a TSCA Section 5(e) consent order,  with such order taking
       effect  on the effective date of the section in Subpart E.             ,
•  A person operating under the terms of a TSCA Section 5(e) consent order that has provisions
   inconsistent with a significant new use identified in Subpart E; the person abides by the
   consent order.
-------
 TSCA Section 5 Inspections	Chapter Six

   •  Process description
   •  Worker exposure
   •  Release information

   •  Health and environmental effects testing data.


Before the inspection, the inspector should review a copy of the specific SNUR and the associated TSCA

Section S(e) order (if applicable), as well as copies of any correspondency with EPA. In some instances,

EPA  may approve alternative  control  measures  (worker exposure or environmental release) for a

particular facility that has submitted a request for a determination of equivalency.  If EPA approves the

request, the submitter may commence manufacture,  import, or processing in  accordance with the

specifications identified in the submitter's request. Therefore, the inspector should review the appropriate

correspondence documenting the approval either found in the company's records or through OPPT.


The following guidelines should assist the inspector in assessing compliance with the above listed elements

of a SNUN and its implementation:
      Verifying commercial  production date (NOT including NOQ.  As is the case for the PMN,
      confirming the accuracy of a particular date is the most important element of the SNUN inspection
      from a compliance standpoint. The inspector should know the 90-day review date for each SNUN
      under compliance review prior to a specific SNUN compliance inspection.

      If a.SNUN under review has been formally withdrawn, the 90-day review  period is terminated,
      eliminating the 90-day review date.  In this case, no commercial manufacture or processing should
      have occurred, and any such commercial manufacture or processing violates TSCA.  Unlike the
      PMN review, the inspector reviewing a SNUN for compliance does not need to concern himself
      with an NOC since the manufacturer (or processor) of a chemical substance for a significant new
      use does not have to notify EPA of the date of commencement of manufacture  (or processing) as
      long as EPA has not initiated any action under TSCA Sections S, 6, or 7 before the 90-day review
      period has elapsed.

      The 90-day review period begins on the date of receipt of the SNUN by the Office of Pollution
      Prevention and Toxics  (OPPT) DCO.1 The inspector must confirm that the submitter has waited
      until the final day of the 90-day review period before beginning to manufacture or process the
      chemical  substance in the manner in which it is considered  a significant new use.  The inspector
      will obtain this information through:

      -  Interviews with company officials.
   1   The Office of Toxic Substances (OTS) has changed its name to the Office of Pollution Prevention and
      Toxics (OPPT).
November 1992                             6-34            TSCA $5 5/8 Inspection Guidance
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Chapter Six	TSCA Section 5 Inspections

       -  Review of production and batch records.

       Sales records may also need to be reviewed and copied to substantiate commercialization of the
       chemical substance.

   •   Verifying chemical identification and structure.   The manufacturer or importer must specify
       whether the chemical substance is a Class 1 or a Class 2 substance or a polymer. The chemical
       name, the molecular formula, the CAS Registry Number (if available), and a structural diagram
       of the chemical substance are required on the SNUN. OPPT verifies the chemical identification
       and structure.  Therefore,  the inspector should only check the MSDS (if available),  chemical
       composition or formulation data, or product literature to verify the chemical identity.

   «   Verifying impurities.   The manufacturer or  importer must list in the  SNUN the  impurities
       anticipated in the chemical substance by name, CAS Registry Number, and weight percent of the
       total substance.   The inspector  should review facility records to verify  the impurities in the
       chemical substance against the information provided in the SNUN. Information on the impurities
       can generally be found in the quality control analyses or specifications for the product. It may
       also be possible  for the inspector to find  information about the impurities by analyzing the
       reactants and raw materials employed during the manufacturing process.

   •   Verifying byproducts. The manufacturer or importer must include in the SNUN any byproducts
       resulting from the manufacture, processing, use, and disposal of the new chemical substance.  The
       inspector can generally find byproducts information in product files.  These  product files  may
       appear in various forms, such  as a product diagram or tree that lists the raw materials, isolated
       intermediates, and byproducts.

   •   Verifying proposed volume of production.  The  manufacturer or importer must include in the
       SNUN an estimate of the maiimum amount  of the chemical  to be manufactured or imported
       during the first year of production and the estimated maximum amount to be manufactured or
       imported during any 12-month period during the first 3 years of production. The inspector should
       verify  these production or import numbers by reviewing the production or import records for the
       first 3  years of production or import.  The inspector should document discrepancies in production
       numbers.

   •   Verifying proposed categories of use.  The manufacturer, importer, or processor must describe
       the intended categories of use of the chemical substance by function and application in the SNUN.
       In addition, the manufacturer, importer, or processor must include an estimate of the  percent of
       production volume devoted to each category of use and the percent of the chemical substance in
       the formulation for each commercial and consumer use.  The inspector must verify the categories
       of use through review of general production, inventory, and sales records.

   •   Verifying process description.  For sites controlled by me manufacturer or processor who submits
       a SNUN, the notice must include a process description of each manufacture, processing, and use
       operation that includes a diagram of the major unit operations and chemical conversions, the
       identity and entry point of all feedstocks, and the points of release of the chemical substance. To
       verify  the processes used to manufacture or process the subject chemical, the inspector should
       walk through the facility, inspecting every major unit process and the points of entry and release
       of the  subject chemical and compare the manufacturing process diagram to in-plant operations.
       An example of a manufacturing operation is presented in Figure 6-5. Any discrepancies between
TSCA 39 5/8 Inspection Guidance            6-35                              November  1992
-------
 TSCA Section 5 Inspections	Chapter Six

       what was provided in the SNUN and the in-plant operations should be documented. If possible,
       the inspector should obtain a signed statement from company officials explaining the discrepancy.

   •   Verifying worker exposure.  For sites controlled by the manufacturer or processor, the SNUN
       must supply worker exposure information, including worker activities, the physical form of the
       chemical substance to which workers may be exposed, the number of workers, and the duration
       of the activities.  The inspector should review records (e.g., monitoring records) documenting
       worker exposure information.  In addition, the inspector should tour the facility and interview
       employees to verify how the workers are exposed to the chemicals (e.g., changing reactor vessels,
       sampling for quality control,  bulk loading, changing; filters, cleaning equipment).  At this time,
       the inspector should also verify the use of protective equipment and  engineering controls  (e.g.,
       gloves, goggles, respirators, closed containment system).

   •   Verifying release and disposal information. For sites controlled by the manufacturer or processor,
       the SNUN must include information on the release of the new substance to the  environment,
       including the quantity and media of release and the type of control technology used. The inspector
       should review records documenting the amount of chemical substance released (e.g., monitoring
       records).  The inspector should document any discrepancies greater than 20 percent that s/he finds
       between the quantity specified in the monitoring records and the estimate provided in the SNUN
       regarding the amount of chemical released.  During a tour of the facility, the inspector should
       examine the control technologies in place as well as the points of and types of release.

   •   Verifying health and environmeptfll ffffigcts testing data.  All health and environmental effects
       testing data in the possession or control of the  manufacturer, importer, or processor, as well  as
       descriptions of health and environmental effects testing data known to or reasonably ascertainable
       by the manufacturer,  importer, or processor must be submitted as part of the SNUN.   The
       inspector  should review the files containing  health  and  environmental effects  testing  data.
       Examples of test data are provided hi Figure 6-6. The inspector should note any testing data that
       were not submitted with the  SNUN and  should obtain copies  of them and  attach them to the
       inspection record.

       The inspector should note that a search for health and environmental effects testing data is very
       difficult and time consuming (i.e., it can take  up to 2 to 4 days).  If during an inspection the
       inspector suspects the company has not submitted the required health and environmental effects
       testing data, s/he may want to consider such a search in a second followup inspection.
6.5  LOW VOLUME EXEMPTION

Under TSCA Section 5(h)(4), the manufacturer or importer of a new chemical substance can apply to
EPA for an LVE if s/he plans to manufacture or import the substance in quantities of 1,000 kg or less

per year.  To manufacture or import a new chemical substance under  the terms of this exemption, a
manufacturer or importer  must submit an LVE notice.   LVE substances are not added to the TSCA

Inventory, but EPA maintains a separate inventory of LVEs granted. A copy of this list is not readily
November 1992                              6-36            TSCA ftft 5/8 Inspection Guidance
-------
 Chapter Six	TSCA Section 5 Inspections
 available, but EPA can produce one upon request.  EPA only grants one LVE per substance; all
 subsequent manufacturers or importers must submit a PMN.

 If, during pre-inspection preparation, the inspector learns that EPA has found the subject chemical to be
 ineligible  for an  LVE,  the  inspector should confirm that the facility complied with the regulatory
 procedures regarding ineligibility.  Once EPA has made the determination of ineligibility, the company
 should have ceased manufacture,  import,  processing, distribution  in commerce, or  use of the new
 chemical substance within 24 hours of notification of EPA's determination. The inspector should confirm
 that the company did not resume any of the previously mentioned activities until the company submitted
 a PMN and the notice review period ended. The inspector should review company correspondence with
 EPA and company records from the period during which the ineligibility was being processed.

 The submission requirements for LVE notices are delineated in Table 6-2.  The regulatory requirements
 that apply to the LVE are summarized in Table 6-6.

 6.5.1  INSPECTION OBJECTIVES
 The inspection objectives to determine compliance with the LVE are as follows:

   •   To verify the accuracy and completeness of the information contained in the LVE notice
   •   To verify adherence by the manufacturer or importer to the LVE specifications.

The inspector should note that the LVE  recordkeeping requirements specify the retention of records to
document the accuracy of the information provided in the LVE notice and to document adherence to the
LVE specifications. Failure to keep any of these records is a violation of 40 CFR §723.50(o).  The
 inspector should encourage the company to consolidate the supporting records (which may be at corporate
headquarters or the production site) when arranging the inspection.

The inspector should not accept at face value the LVE records as provided by the facility.  S/he should
ascertain all of the names and designations for the LVE chemical  and note its mention  in any other
records and data reviews, as well as watch for its potentially illegal manufacture, sale, storage, or use
during the plant tour.
TSCA»5/8 Inspection Guidance            6-37                              November 1992
-------
TABLE 6-6 LOW VOLUME EXEMPTION
                                                            g
                                                            SP
: Authority
(^.CWBL^f.
723.50(e)(l)
723.50(e)(l)(i)
723.SO(e)l)(ii)
723.50(e)l)(iii)
723.50(e)l)(iv)
723.50(e)l)(v)
723.50(e)l)(vi)
723.50(e)l)(vii)
723.50(e)l)(viii)
723.50(i)
723.50(j)
723.50(o)
723.50(o)(l)
723.50(o)(2)
723.50(o)(2)
*^.W *
iitlM^iimtioa

50 PR 16489-90
April 26, 1985
50 FR 16491
April 26, 1985
50 FR 16491
April 26, 1985
50 FR 16492
April 26, 1985
-5-. - L -" • ^ *
' " it«tfttiftiliW ft«Mtti**nA«nic >- ^ > '. .
: & •• s , ••„*'•••.•••.•••••• ^tvf^j.
Notice must include:
Name and address of manufacturer and name and telephone number of a technical contact
Type of exemption
Chemical identification and structure
Description of use
Name and address of site of manufacture (except for imported chemical substances)
Certification that chemical will be manufactured or imposed in compliance with LVE terms
Test data in submitter's possession or control
Exposure controls may be submitted; if submitted, manufacturer must maintain the controls
throughout LVE period.
• Any change in site of manufacture or use of chemical must be submitted to EPA in notice.
• Manufacturer must notify processors and users of use restrictions and of any. controls specified in
LVE notice. Notification may be made by means of a container labeling system, written
notification, or any other method that adequately informs.
Recordkeeping:
• Annual production volume of chemicals under LVE
• Documentation of information in exemption notice and compliance with LVE terms
• Records must be retained for 5 years after their date of preparation.
                                                            IP
-------
Chapter Six _ TSCA Section 5 Inspections

6.52 INSPECTION GUIDELINES

Before the inspection, the inspector should review a copy of the LYE notice, a copy of the LVE Federal
Register notice, and copies of correspondence with EPA regarding the exemption (including a copy of

the bonafide inquiry, if applicable). At the plant site, the inspector will verify the information contained

in these  copies by reviewing company records, interviewing company employees, and touring the facility.


The following elements generally constitute the LVE components that require compliance verification

during an inspection, as appropriate:
   •  Manufacturer's name and technical contact
   •  Type of exemption
   •  Chemical identification and structure

   •  Description of use

   •  Site of manufacture
   •  Health and environmental effects testing data
   •  Customer notification

   •  Exposure controls.
The following guidelines should assist the inspector in assessing compliance with the above-listed elements

of an LVE notice and its implementation:
      Verifying Frcfliinufacturer's nflmff flTVl! technical contgcLjjgd, type of exemption.  The inspector
      generally verifies these two items when reviewing records during pre-inspection planning.  If
      during an inspection the inspector discovers that the company is manufacturing a chemical under
      an LVE, the inspector should note this information to include it in the inspection report.

      Verifying chemical identification  flfld. Structure.  The inspector  should compare the identity
      (structure) of the chemical actually manufactured or imported and sold during the LVE period to
      information and/or data contained in the LVE notice.  The inspector will want to look for the
      identification of the chemical substance as either a Class I or Class n substance or as a polymer,
      impurities anticipated in the new chemical substance, and a generic name for a new chemical
      substance claimed confidential. The chemical identity and structure should be verified by OPPT.
      Therefore,  die inspector should check  the  MSDS  (if available), chemical  composition  and
      formulation data, or product literature for the subject chemical to  verify its identity.   If the
      inspector finds any discrepancies, s/he should note them and obtain copies of supporting data for
      followup with EPA Headquarters.

      Verifying description of use. The inspector  should review the LVE notice to confirm that the
      notice includes a description of the intended use of the new chemical substance by function and
      application and describes whether the use is industrial, commercial, or consumer. The inspector
      should verify that the actual use(s) of the LVE chemical accurately reflects the information in the
      LVE notice.
TSCA 55 5/8 Inspection Guidance            6-39                              November 1992
-------
TSCA Section 5 Inspections                    	                              Chapter Six
                                          DEFINITIONS
         Consumer - The new chemical substance or products containing the substance will be
         used by private individuals in or around a residence, or during recreation, or for any
         other personal use or enjoyment (e.g., automotive polish, dyed wearing apparel,
         household cleaners, etc.)  If a consumer use is identified, then the EPA requests the
         following information be provided on an attached continuation sheet: a detailed
         description of the use of the new chemical substance expected in consumer products and
         any reactions that cause the substance to lose its identity in the consumer product.

         Industrial - The new chemical substance or products containing the substance will be used
         at the site of other manufacturers, importers, or processors (e.g., textile dyeing, paint
         formulation, use of a curable resin to manufacture an article).

         Commercial - The new chemical substance or products containing the substance will be
         used by a commercial enterprise providing a consumer service (e.g., use by commercial
         dry cleaning establishments, use by painting contractors, or use by roofers in commercial
         building construction).
      To do this, the inspector should review shipping, sales, and customer records and particularly
      watch for changes in the use category  (e.g., the LVE notice indicates an  industrial use, but
      company records indicate a consumer use) because the 'resulting exposure to the chemical can be
      significantly different. If the inspector finds a discrepancy, s/he should determine whether a new
      notice has been submitted that indicates a change from the original, reported use of the chemical
      substance.  If no new LVE notice has been completed, the inspector should obtain copies of the
      supporting documentation and signed statements from company officials.

      Verifying site of manufacture.  The LVE notice must  specify the site of manufacture, and this
      information legally binds the company.  Therefore, the inspector should verify that the actual site
      of the manufacturing activity matches the site specified in the LVE notice or in subsequent notices
      indicating a site change.

      Any change in the manufacturing site (or use) of the LVE chemical substance must be submitted
      to EPA by means of a new notice that indicates, in addition to the new site (or use), the identity
      of the new chemical substance, the manufacturer's name, and the name and telephone number of
      a technical contact.  However, this notice need not include other information submitted to EPA
      in the previous exemption notice.
   •  Verifying health ft^fl envi"y«'"pffal effaas testing fatfl The regulations require that all health and
      environmental effects testing data in the submitter's possession or control and descriptions of other
      data that are known to or reasonably ascertainable by the submitter and that concern the health and
      environmental effects of the new chemical substance be submitted to EPA as  part of the LVE
      notice.  The inspector should review the files containing health and environmental effects testing
      data.  To verify mat these critical data were generated or available prior to the LVE submission,
      the inspector should confirm that the dates of such submitted data or information are reliably
      documented.
November 1992                               6-40            TSCA 85 5/8 Inspection Guidance
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 Chapter Six	TSCA Section 5 Inspections

       The inspector should note that a search for health and environmental effects testing data is very
       difficult and time consuming  (i.e., it can take up to  2 to  4 days).  Therefore, if during an
       inspection the inspector suspects the company has  not submitted the required health  and
       environmental effects testing data,  s/he may want to consider conducting such a search in a second
       followup inspection.

   •   Verifying customer notification.  The inspector should verify that the manufacturer or importer
       has notified processors and industrial users of the use restrictions and controls applicable to the
       chemical substance as specified in the LVE notice. The inspector can verify that the manufacturer
       or  importer has fulfilled the customer notification requirements by checking for the  means by
       which such notification was made, which could include the following:

       -   A container labeling system

       -   Written notification

       -   Any other method that adequately informs.

       If the manufacturer or importer has not complied with the notification requirement, the inspector
       should obtain written statements from the facility officials as to whether they were aware of the
       requirement and/or why it was not followed.  If the  inspector has reason to believe that the
       customer was not adequately  informed  and/or  is not complying with the use restrictions or
       controls, the inspector may consider a secondary inspection (i.e., of the customer).

   •   Verifying exposure controls:  In the event the manufacturer chooses to provide information on
       exposure controls or other controls for the new chemical substance to support the exemption notice
       (information deemed optional in the regulations), the inspector should verify that the manufacturer
       has maintained the legally binding controls throughout die period during which the manufacturer
       is operating under the LVE.  Such controls might include limits on the number of workers
       exposed and the duration of the exposure. The inspector should examine the manufacturing area
       to verify these controls, and if exposure levels have been specified the inspector should check the
       appropriate monitoring records.   The inspector should also interview company employees,  if
       necessary.
6.6 RESEARCH & DEVELOPMENT EXEMPTION

To engage in R&D activity, a manufacturer or importer is not required by TSCA Section 5(h)(3) to apply

for an R&D exemption.  The manufacturer or importer only needs to demonstrate that small quantities

of the  new chemical substance are being used solely  for scientific experimentation or analysis, for

chemical research on, or for analysis of such substance or another substance,  including research or

analysis for the development of a product.  Neither the statute  nor the regulations  define "small

quantities," but the manufacture or import of a  low volume of a new chemical  substance does not

automatically qualify for the R&D exemption. A  technically qualified person must supervise the R&D
activity and the manufacturer  or importer  must  notify all persons engaged in the experimentation,
TSCA fifi 5/8 Inspection Guidance            6-41                               November 1992
-------
 TSCA Section 5 Inspections	Chapter Six
 research, or analysis of any risk to health that the manufacturer or importer has reason to believe may
 be associated with the chemical substance.
As specified in Table 6-2, to be eligible for an R&D exemption, a manufacturer or importer is not
required to submit an application or a notice to EPA.  The specific regulatory requirements that apply
to the R&D exemption are summarized in Table 6-7.

6.6.1 INSPECTION OBJECTIVES
The objective of this type of inspection is to verify that the company is manufacturing or importing the
new chemical substance to meet the criteria for the R&D exemption.

6.6.2 INSPECTION GUIDELINES
To determine compliance by any facility employing (knowingly  or unknowingly)  the TSCA R&D
exemption, the TSCA inspector should assess the following information, either from company officials
or through review of company records: whether a discrete R&D laboratory or operation is at or near the
facility being inspected; whether new chemicals (according to the TSCA definition) are being synthesized
for eventual commercialization and, if so, the different kinds of chemicals being synthesized (from the
standpoints of general chemical structure and intended use); and, for any written company policy that
addresses  the development of new  chemicals, whether  the policy  addresses notification of risk
requirements, sample labeling and other customer notification procedures, recordkeeping requirements,
the amount of R&D material that can be produced, designation of technically qualified  individuals,
procedures for risk evaluation and required health risk notification,  and prudent laboratory practices.

   •  Verifying company policy.  Ideally, compliance verification relative to the use of the TSCA R&D
      exemption should be conducted for all new commercially-intended chemicals  synthesized since
      May 13,  1983 (the date of the promulgation of the PMN regulations); however, emphasis should
      be placed on those compounds synthesized since August 4,1986, when the stayed R&D provisions
      became effective.  In  addition to reviewing the  company's R&D policy, the inspector should
      review facility operations and recordkeeping practices to establish the typical or normal pathway
      of a new chemical from initial benchtop synthesis through pilot-plant scale-up to final commercial
      production.  The major items that the inspector should identify and review are the responsible
      person for specific R&D activities  (the technically  qualified individual),  the policies and
      procedures for recordkeeping and notification, and health risk assessments.
    The inspector should collect a copy of the R&D policy if one of the following situations arises:
      -  Additional tune is needed for its review
November 1992                              6-42            TSCA 8ft 5/8 Inspection Guidance
-------
TABLE 6-7 RESEARCH AND DEVELOPMENT EXEMPTION
Authority
WSTOlJi
720.36
720.36(a)(2)
720.36(c)(2)(i)
720.36(c)(2)(u)
720.36(b)(l)(i)-(iv)
720.78(b)(l)(i)-(iv)
720.78(b)(3)
720.36(e)
720.36(f)
720.36(g)

48 FR 21746
May 13, 1983
51 FR 15102
April 22, 1986
48 FR 21746
May 13, 1983
51 FR 15102
April 1986
51 FR 15102-15103
April 22, 1986
51 FR 15103
April 22, 1986
51 FR 15102
April 22, 1986
51 FR 15102
April 22, 1986
51 FR 15102
April 22, 1986
Requirements
•. ,,
To qualify for exemption:
• Chemical must be manufactured or imported in small quantities solely for R&D
• Manufacturer or importer must notify all persons associated with R&D of health risks
• Chemical must be used by or supervised by technically qualified individual [defined in
720.3(ee)]
Manufacturer or importer notification of person employed by the firm and persons not employed
by the firm:
• Substance is to be used for R&D only
• Health risks associated with the R&D chemical
(See Table 6-8 for specific requirements)
Manufacturer or importer must determine if any potential health risks exist by evaluating:
• Information on significant adverse reaction by persons exposed to chemical reasonably
associated with such exposure
• Information provided by supplier or other person of health risk
• Health and environmental effects data
• Information on health effects accompanying any EPA rule or order issued under TSCA Sections
4, 5, or 6.
Manufacturer or importer recordkeeping requirements
(See Table 6-9 for specific requirements).
R&D records must be retained for 5 years after they are developed
After completion of R&D, chemical may be disposed of in accordance witji applicable regulations
or used commercially (1) in burning as a fuel or (2) in reacting or in processing to form other
chemicals for commercial purposes.
Once R&D has been completed, R&D substances existing as impurities in a product or
incorporated into an article are not subject to notification requirements in 720.36(a), (b), and (c).
R&D activities done exclusively to determine potential use of chemical as a pesticide are exempt
from requirements of Section 720.36.

-------
TSCA Section 5 Inspections	Chapter Six


      -  There are deviations from the requirements of TSCA

      -  There are operational deviations from the policy's provisions.

     Through interviews with appropriate laboratory personnel at the site, the inspector should identify
     the senior product development or research chemists responsible for the various product lines of
     commercial interest. In this respect, it may assist the inspector in preparing a chart of all use and/or
     chemically discrete classes of compounds and then individually ascertain:

      -  Whether research on each new chemical  is ongoing or not.

      -  The location of any research.

      -  Whether research  is taking place locally (i.e.,  at  or near the inspected facility or under
         immediate contract) and the person who is responsible for its undertaking.

     Once this information is obtained and the total R&D scope is established, the inspector may want
     to perform either a total or a limited verification, as appropriate.  To do this, the inspector should
     review laboratory notebooks and interview research chemists. At a minimum, the inspector should
     select several chemicals-from various use and/or chemical categories  for further inquiry.  S/he
     should note the synthesis of potentially new commercial compounds in the laboratory, including
     dates, starting materials, and proposed target compound.  The inspector should also note additional
     purification steps and any subsequent identity or property determinations.   S/he should track the
     selected new compounds through interviews, and records,  and risk evaluation to their current status.

     The inspector should confirm all chemicals subject to bonafide inquiries not found on the TSCA
     Inventory for compliance with the R&D exemption. Thus, the inspector should obtain copies of all
     such bonafide inquiries before inspecting each facility. Semiannual printouts from EPA can include
     the list of bonafide inquiries if the inspector specifically asks the Office of Compliance Monitoring
     (OCM) to add the list to the printout.

     Determining if newly synthesized or imported chemicals at a facility truly meet the R&D exemption
     may be difficult  to establish  immediately.   If company  records indicate that the chemical  is
     manufactured for a purpose other than R&D, but the company is claiming the R&D exemption, the
     inspector should copy the R&D records and other records that document the use of the manufactured
     chemical,  including batch records, volume of the chemical manufactured, customer lists,  invoices,
     and shipping records.

   •  Verifying the technically-qualified individual. The inspector should identify and interview the
      person(s)  responsible for the R&D program (generally, the R&D Director or  Laboratory
      Supervisor).  More than one such person may supervise activities involving a particular chemical
      substance. The inspector should document her/his technical background (i.e., education, training,
      and work experience) and her/his responsibilities in the position.

   •  Verifying recordkeeping and notification.   The inspector should review the facility records  to
      verify that the facility is complying with the recordkeeping and notification requirements.  Any
      new TSCA chemical covered by the R&D exemption that was synthesized or imported by a facility
      after August 5, 1986, must meet the recordkeeping and  notification  requirements presented  in
November 1992                               6-44            TSCA 88 5/8 Inspection Guidance
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Chapter Six
                      TSCA Section S Inspections
      Tables 6-8 and 6-9.  If these requirements are not met, or if records or notifications appear to be
      incorrect or missing, then the inspector should fully document these potential violations through
      copies of substantiating documents and/or statements from company officials.  The  inspector
      should obtain a list of customers to whom the chemical was sold.
                TABLE 64 NOTIFICATION OF RISKS-R&D EXEMPTION
Wiw must be
Notified
Persons employed
by c firm for R&D
work
Persons not in a
firm's employ to
whom it distributes
R&D substances
Method of
Notification
Any appropriate
means that adequately
informs
In writing
Content of
Notification
1 . Risks associated with
R&D substance
1. Risks associated with
R&D substance
2. Requirement that
substance be used
only for R&D
Authority
(40CFR)
720.36(a)(2);
720.36(c)(l)
720.36(a)(2);
720.36(c)(2)
6.7 TEST MARKETING EXEMPTION
TSCA Section 5(h)(i) authorizes EPA to provide an exemption for manufacturers who produce or import
new chemical substances for test marketing purposes if the chemical substances do not present an
unreasonable risk of injury to health or the environment.  This is not an automatic exemption; the
manufacturer or importer must apply for it to EPA.  The submission requirements for the TME are
summarized in Table 6-2.  The intent of a TME is to allow a company to determine market capability
in a competitive situation for a definite period of time. Generally, all conditions set forth in the TME
application are to be followed by the applicant.  In addition, EPA may impose restrictions on the test
marketing activities with which the facility must comply.

The regulatory requirements that apply to the TME are summarized in Table 6-10.

6.7.1  INSPECTION OBJECTIVES
The inspection objectives to determine compliance with the TME are:

   •  To verify the accuracy and completeness of the information provided in the TME application.
TSCA 99 5/8 Inspection Guidance
6-45
November 1992
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I
                                                  TABLE 6-9  RECORDKEEPING-R&D EXEMPTION
                                 All manufacturers using the R&D
                                 exemption (except labs using prudent
                                 lab practices)
                                 Labs using prudent lab practices
                                 Manufacturers distributing R&D
                                 substances to persons outside their
                                 employ
                                 Producers of more than 100 kg/year
1. Copies of or citations to information
   reviewed to determine risks

2. Documentation of the nature and
   method of risk notification
1. Documentation of prudent lab
   practices .
1. Names and addresses of those who
   received substance

2. Identity of substance

3. Amount distributed

4. Copies of written notification
1. Record of identity of substance

2. Production volume

3. Disposition of substance
720.78(b)(l)(i)
                                                                                                           720.78(b)(l)(ii)
720.78(b)(l)(iii)
720.78(b)(l)(iv)
720.78(b)(2)
i •*
§
-------
01
oe
TABLE 6-10 TEST MARKETING EXEMPTION (TME)
Authority J
t*C*KK3
720.38(b)
720.38(b)(l)
720.38(b)(2)
720.38(b)(3)
720.38(b)(4)
720.38(b)(5)
720.38(e)
720.78(c)
:^^^=
if-Hifi^s^:"-< v-v
48 FR 21746-47
May 13, 1983
48 FR 21747
May 13, 1983
48 FR 21751
May 13, 1983
- % v ",,,*'' " -A -' N
'V '---'"- ' - " " ^ " v. " W,l;> ',>
^-^ ^;>^'Mx. ,,,,,; Bagnlato*^ Requirements , -\ *""S
....'.....'!.....'!<.'*'!.??.< /:> 	 -'-'.'.{ 	 ^. 	 %__.. 	 '.": 	 '...y.. '. _ _ *
Application must include:
• Existing health and environmental effects data including chemical/physical properties; if no data
exists, discussion of toxicity based on structure-activity relationships (SAR) and relevant data on
chemical analogues
• Maximum quantity of substance to be manufactured or imported
• Maximum number of persons who may be given the chemical during test marketing
• Maximum number of persons to be exposed and duration and routes of exposure
• Description of test marketing activity, its length, and how it will be distinguished from R&D and
full-scale commercial production.
EPA may impose restrictions on the exemption.
Recordkeeping:
• Documentation of information in the TME application and of compliance with EPA-imposed
restrictions must be retained.
• Records must be kept for 5 years from final date of manufacture or import under TME.
-------
 TSCA Section 5 Inspections	Chapter Six
   •   To verify adherence by the manufacturer or importer to the TME conditions and to any additional
       EPA-imposed restrictions.
The inspector should keep in mind that TME recordkeeping requirements specify the retention of records
to document the accuracy of the information contained in the TME  application and  to document
compliance with any EPA-imposed restrictions.  Failure to keep any of these records is a violation of 40
CFR §720.78(c). The supporting records for the TME may be consolidated by the company in one file,
or they may be distributed at different production sites.  The inspector should encourage the company
to consolidate these records for review when arranging the inspection.

The inspector should not accept at face value the TME records as provided by the facility.  S/he should
ascertain all of the  names and designations for the TME chemical and  note its mention in any other
records and data reviews, as well as watch for any potentially illegal manufacture, sale, storage,  or use
during the plant tour.

6.7.2 INSPECTION  GUIDELINES
Before the inspection, the inspector should review a copy of the TME application, a copy of the Federal
Register notice, and copies of any correspondence with EPA regarding review and/or approval  of the
application.  At the plant site,  the inspector should verify the information contained in these documents
by reviewing company records, interviewing company employees, and touring the facility.

The following elements generally constitute the TME components that will require compliance verification
during an inspection:

   •  Period of applicability
   •  Health and environmental effects testing data
   •  Chemical identification and structure
   •  Maximum quality of the chemical substance and number of customers
   •  Maximum number of persons exposed and duration and routes of exposure
   •  Description of the test marketing activity
   •  EPA-imposed restrictions.
November 1992                              6-48            TSCA 99 5/8 Inspection Guidance
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 Chapter Six _ TSCA Section S Inspections

 The following guidelines should assist the inspector in assessing compliance with die above-listed elements

 of die TME:
   •   Verifying  period  of applicability.   The  inspector should review general production, batch,
       inventory, and sales records to verify that all commercial manufacture  or  import of the TME
       chemical was done during the period of time designated in the TME application. The inspector
       should stan the review of these records with records dated approximately one month  prior to
       EPA's receipt of  die TME application.   If the inspector finds  deviations  from the period of
       applicability in the TME application, s/he should document the deviations  with  copies of
       appropriate records and/or signed statements from company officials.

   •   Verifying health and environn^ntfll effects testing data.  The inspector  should review the files
       containing health and environmental effects testing data.  The regulations require that all existing
       health and environmental effects testing data be supplied to EPA as part of the TME application.
       The inspector should verify with die person responsible for the test marketing program that all
       records containing health and environmental effects data have been provided for review. These
       test data may  be  in the form of health  effects data, ecological data,  physical and chemical
       properties  data, environmental effects characteristics, monitoring data,  or  any data related to
       human exposure to or environmental release of the chemical substance.

       This requirement  also  includes die  results of all  determinations of  chemical and physical
       properties.  Therefore, the inspector should review R&D  files, notebooks,  and benchsheets for
       TME chemicals to ascertain if all testing  data were submitted with die TME application.  The
       inspector should collect copies of any  documents discussing toxicity based  on structure-activity
       relationships or analogue data  that were not included with or referenced in  the application to
       document a potential violation.  To verify mat these critical data were generated or available prior
       to the TME submission, the inspector should confirm that the dates  of such  submitted data or
       information are reliably documented.
       Verifying chemical identificatfo^ and structure.  The inspector should compare the identity and
       structure of die chemical actually produced or  imported and sold during die TME period to
       information and/or data contained in die application. Since the chemical identity and structure are
       verified by OPPT, the inspector should  not check chemical or instrumental analyses, such as mass
       or ultraviolet spectra.  Rather, the inspector should only check the MSDS, chemical composition
       or formulation data, or product literature for the subject chemical to verify  its identity.  If die
       inspector finds any discrepancies, s/he should note diem and obtain copies of supporting data for
       followup with EPA Headquarters.

       Verifying ffliffiifrmPI Quantity of die chemical substance and number of customers.   The inspector
       should review inventory, batch, and sales records for a facility to determine die maximum quantity
       of die chemical substance die applicant may manufacture or import for test marketing and die
       maximum number of persons who may be given me chemical substance during test marketing.
       Thus, die inspector must be familiar with all trade, generic, and code names of die TME chemical
       substance, including processed materials in which it was used. The inspector should find that this
       information is consistent with mat in die TME notice.  If the inspector discovers any deviations,
       s/he should uoroughly document die deviation and copy die appropriate records.   The inspector
       should note mat the die maximum quantities in die TME are binding; any excess quantities above
       die maximum wuantity are a violation and should be documented.
TSCA ft* 5/8 Inspection Guidance            6-49                               November 1992
-------
 TSCA Section 5 Inspections	Chapter Six

   •   Verifying maximum number of persons exposed and duration and exposure routes. The inspector
       should review facility  monitoring records, production schedules,  and employee records to
       determine the maximum number of persons who may be exposed to the chemical substance as a
       result of the test marketing program.  The inspector should find that these records  also provide
       some  information regarding the  duration and route(s) of such exposure.  The inspector should
       discuss with the  manufacturer or importer  how these numbers were estimated for the TME
       application.

   •   Verifying description of the test marketing activity.   The inspector should carefully review the
       description  in the TME application of the proposed use(s) and other  activities for the subject
       chemical substance. The inspector should review customer correspondence, shipping records,  and
       sales records to determine whether the use, processing, final products, and potential exposure
       exceed that  stated or implied in the TME application. The inspector should also discuss the  test
       marketing activities with  the lead person responsible for  the test marketing, as well as with
       employees involved in the test marketing program. S/he should document potential violations with
       copies of records  and signed statements from the appropriate employees, as necessary.

   •   Verifying EPA-imposed restrictions.  The inspector also  verifies compliance with any EPA-
       imposed restrictions or  limitations during the  inspection.  These restrictions are noted in  the
       Federal Register notice that grants the exemption (see Figure 6-8 for a sample notice). In addition
       to reviewing the Federal Register notice, the inspector should review (and discuss with the OPPT
       Notice Manager)  all additional correspondence with EPA.  The OPPT Notice Manager can be
       found  by in MTTS.  Each TME will have different restrictions, varying in number and type
       depending on EPA's concern for that chemical  substance.  These restrictions often  apply to  the
       elements already  described  (i.e., reductions in the  proposed production volume, number of
       customers, or time period of applicability); limitations on other  elements may also apply.  For
       example, a  TME may impose a requirement that worker protection equipment (e.g., goggles,
       gloves, or NIOSH-approved respirators) be worn by personnel coming into contact with the TME
       chemical. The inspector should document potential violations by copying records that support the
       violation and by obtaining signed statements from company officials, if necessary.
November 1992                               6-50            TSCA 99 5/8 Inspection Guidance
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 Chapter S«
                                                              TSCA Section 5 Inspections
     4TU
                            FIGURED


   SAMPLE FEDERAL REGISTER NOTICE GRANTING
               TEST MARKETING EXEMPTION

FeckrtJ ItogUBtr /  Vol. 
-------
 TSCA Section 5 Inspections                                                       Chapter Six
                                               TIPS
                   Examples of EPA-imposed restrictions and how to verify compliance

         Production limits:  Examine manufacturing and processing records.  Identify those
         records that show each day of production, dates, and amount produced. Note when
         production began and ended.

         Distribution/shipping records requirements:  Examine records that indicate customers,
         amounts shipped, and sales volume.

         Use limits:  Examine bill of lading for statement of use of the substance.

         Worker exposure limits:  Observe plant operations.  Inspect manufacturing area for
         number of workers exposed and for exposure duration.  If exposure levels are specified,
         check monitoring records.

         Manufacturing records:  Examine the manufacturing process to determine if the substance
         is produced in a closed system, including packaging facilities and storage and transfer
         lines.

         Safety requirements: Determine if the company has MSDSs and/or labeling on specified
         products. Observe workers to see if worker protection measures are being implemented.

         Test data: Ask to see any test data on the substance in question.

         Disposal requirements:  Examine records and describe the manner or method of disposal.
6.8 POLYMER EXEMPTION

Under TSCA Section 5(h)(4), the manufacturer or importer of a new chemical substance can apply to

EPA for a PE if the chemical substance:


   •  Meets the definition of a polymer molecule found in 40 CFR §723.250(b)(12), which is "a
      molecule mat includes at least four covalently linked subunits, at least two of which are internal
      subunits."

   • , Is not specifically excluded under 40 CFR §723.250(d) because it is characterized  as being or as
      having one of the following:

      -  Cationic polymer

      -  Polymer containing less than 32 percent carbon by weight  .
November 1992                              6-52            TSCA 55 5/8 Inspection Guidance
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 Chapter Six	TSCA Section 5 Inspections

       -  Elemental limitations: polymer that does not contain at least two of the elements carbon,
          hydrogen, nitrogen, oxygen, silicon, or sulfur as an integral part of its composition, or polymer
          that contains as an integral pan of its composition,  except as impurities, any elements other
          than (i) carbon, hydrogen, nitrogen, oxygen, silicon,  and  sulfur; (ii) sodium,  magnesium,
          aluminum, potassium, or calcium as the monatomic counterions  Na*, Mg*2, AT3, K*, or
          Ca*2;  and,  (iii)  less than 0.20  weight percent of any  combination  of lithium, boron,
          phosphorous, titanium, manganese, iron, nickel, copper, zinc, tin, and zirconium

       -  Biopolymer, synthetic equivalent  of a biopolymer, or a derivative or a modification of a
          biopolymer  if the initial biopolymer is substantially intact

       -  Polymer manufactured from reactants containing halogen atoms or cyano groups

       -  Polymer containing reactive functional groups

       -  Polymer that degrades, decomposes, or depolymerizes.

   •   Meets one of the following two criteria:

       •  Has a number-average molecular weight greater than 1,000

       -  Is a polyester as defined in 40 CFR §723.2SO(b)(10) and is  manufactured solely from one or
          more of .the reactants from a specified list.


The submission requirements for a PE are  summarized in Table 6-2.   Unlike the other exemptions,

substances subject to  PEs  are added to the TSCA Inventory.   An NOC must  be submitted  when

commercial production begins.


If during pre-inspection preparation the  inspector learns that EPA has found the subject chemical to be

ineligible for .the PE, the inspector should confirm that  the facility complied with the regulatory

procedures regarding  ineligibility.  Once EPA makes the determination of ineligibility,  the company

ceases manufacture, import, processing, distribution in commerce, or use of the new chemical substance
within 24 hours of notification of EPA's determination. The inspector should confirm that the company

did not  resume any of the previously mentioned activities until the company submitted a PMN and the

notice review period  ended.  The inspector should review company correspondence with EPA and

company records from the period during which the ineligibility was being processed.


The regulatory requirements that apply to a polymer exemption are summarized in Table 6-11.
TSCA It 5/8 Inspection Guidance            6-53                              November 1992
-------
f
in
                                                         TABLE 6-11 POLYMER EXEMPTION (PE)
723.250(0

723.250(0(2)(i)
723.250(f)(2)(ii)
723.250(0(2)(iii)
723.250(0(2)(iv)
723.250(0(2)(v)
723.250(0(2)(vi)
723.250(0(2)(vii)
723.250(0(2)(viii)
723.250(0(2)(ix)
723.250(0(2)(x)
723.250(0(2)(xi)
723.250(0(2)(xii)
              723.250(r)(l)

              723.250(r)(l)
              723.250(r)(2)(i)
              723.250(r)(2)(i)
              723.250(r)(2)(i)
              723.250(r)(2)(ii)(A)
              723.250(r)(2)(ii)(B)
                                   49 FR 46088-89
                                   November 21, 1984
                     49 FR 46091
                     November 21, 1984
                                                                                                                                         I
                                                                                                                                         IP
                                                                                                                                         I
                                                                                                                                         tfl
Notice must include:

   Name and address of manufacturer and name and telephone number of a technical contact
   Type of exemption
   Name and address of site(s) of manufacture (except for imported chemical substances)
   Chemical identification
   Number average molecular weight
   Residual monomer and other reactants and low molecular weight species content
   Impurity information
   Maximum annual production volume
   Category of use
   Generic chemical identity and use
   Test data and other data
   Certification.
Recordkeeping:

  Records must be retained for 5 years from the date of commencement of manufacture
  Production volume for first 3 years of manufacture
  Date of commencement of manufacture
  Documentation of first two items
  Information to demonstrate that the new polymer is not specifically excluded from exemption
  Information to demonstrate that the polymer meets the exemption criteria:  (1) > 1,000 number
  average molecular weight; (2) polyester polymer.
                                                                                                                                                      IF
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 Chapter Six	TSCA Section 5 Inspections
 6.8.1  INSPECTION OBJECTIVES
 Before the inspection, the inspector should review a copy of the PE notice, a copy of the PE Federal
 Register, and copies of any correspondence with EPA regarding the exemption.  At the plant site, the
 inspector will verify the information contained in these  documents by reviewing company records,
 interviewing company employees, and touring the facility.

 The inspection objectives to determine compliance with the PE are as follows:

   •   To verify the accuracy and completeness of the information contained in the PE notice
   •   To verify adherence by the manufacturer or importer to the PE specifications.

 The inspector should note that the PE recordkeeping requirements specify the retention of records to
 document the accuracy of information provided in the PE notice and to document compliance with its
 terms.  Failure to keep  any of these records constitutes a violation of 40 CFR  §723.250(r).  The
 supporting  records may be consolidated by the company in one file (perhaps at corporate headquarters)
 or they may be at the production site.  The inspector should encourage the company to consolidate these
 records for review when arranging the inspection.

 The inspector should not accept at face value the PE records as provided by the facility.  S/he should
 ascertain all of the names and designations for the PE chemical and note its mention in any other records
 and data reviews, as well as watch for its potentially illegal manufacture, sale, storage, or use during the
plant tour.

6.8.2 INSPECTION GUIDELINES
In general,  the inspector reviews all of the above-listed elements for compliance.   The following
guidelines should assist the inspector in assessing this compliance with the PE:
   •  Verifying manufacturer's  name and technical contact and type of exemption.  The inspector
      generally verifies these two items when reviewing records during pre-inspection planning.  If an
      inspector discovers that the company is manufacturing a chemical under a PE, the inspector should
      note this for inclusion in the inspection report.
   •  Verifying site of manufacture.   The inspector  should  verify  that the  actual site  of the
      manufacturing activity matches the site listed in the PE notice.
TSCA 55 5/8 Inspection Guidance            6-55                              November 1992
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 TSCA Section 5 Inspections _ Chapter Six

   •   Verifying chemical identification and structure, and related information.  The inspector should
       compare the identity of the chemical substance actually manufactured or imported and sold against
       information and/or data contained in the PE. The inspector should review information and records
       that include the following items: the chemical name; the CAS Registry Number of the substance;
       the maximum percent (by weight) of each reactant used at any weight percent to manufacture the
       polymer; a structural diagram, if possible; the number-average molecular weight; and the residual
       monomer and other reactants and low molecular weight species content.  These records could be
       in the form of chemical composition or formulation  records or MSDSs.  The manufacturer or
       importer is also required to specify any reactants used at 2 weight percent or less that should be
       included as part of the polymer description on the Inventory.   The  inspector  should compare
       synonyms and trade names of the chemical substance identified in the PE notice to those used in
       company records.  If chemical  identity information is claimed confidential in the PE notice, the
       inspector should find a generic, nonconfidential description of the identity.
   *  Verifying jrppflflfy information.  The inspector should check the identity of each impurity, by
      chemical name and CAS Registry Number, and the estimated maximum weight percent of each
      impurity anticipated to be present in the polymer. If there are unidentified impurities, the inspector
      should verify the estimate of their total weight percent.

   •  Verifying production volume.   The inspector should review production records to verify the
      maximum production volume during the first 12-month period of production and the maximum
      production volume for any consecutive 12-month period during the first 3 years of production.

   •  Verifying category of use.  The PE notice must include a description of each intended use of the
      new chemical substance by function and application and describe whether the use is industrial,
      commercial, consumer, and/or site-limited.  The inspector should confirm that the actual use(s)
      of the polymer accurately reflect the information in the PE notice. If category of use  information
      is claimed confidential in the PE notice, the inspector should find a nonconfidential  generic use
      description.
                                         DEFINITIONS
         Generic Use Description - The generic use description should reveal the intended category
         of use to the maximum extent possible.  For example, the specific use of a new substance
         as an antioxidant in a lubricant could be described genericatty as a lubricant additive; a
        fiber-reactive dye far nylon carpeting could be described genericalty as a dye for fibers.
         If such a generic description does not provide a sufficient indication of potential exposure,
         the description can also describe the degree of containment of the new chemical
         substance, as shown in the list below; however, a generic use description that solely
         describes the degree of containment, such as 'open,  non-dispersive use, * is not
         acceptable.
   •  Verifying health and environment ffffpffs testing data. The regulations require that all health and
      environmental effects testing data in the submitter's possession or control, descriptions of other
      data mat are known to or reasonably ascertainable by the submitter and that concern the health and
      environmental effects of the polymer, and a description of data on related chemicals all be supplied
November 1992                              6-56            TSCA $9 5/8 Inspection Guidance
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 Chapter Six	TSCA Section 5 Inspections
       to EPA as part of the PE notice.  The inspector should review the files containing the health and
       environmental  effects  testing  data.   Copies of any  documents discussing  structure-activity
       relationships or analogue data that were not included with or referenced in the notice are also to
       be collected so as to document a potential violation.  The inspector should confirm that the dates
       of such submitted data or information are reliably documented. To verify that these critical data
       were generated or available  prior to  the  PE submission,  information should be  reliably
       documented.
       The inspector should note that a search for health and environmental effects testing data is very
       difficult and time-consuming (i.e., it can  take up  to 2 to 4 days).  Therefore,  if during an
       inspection the inspector suspects  the company has not submitted  the  required health  and
       environmental effects testing data, s/he  may want  to consider conducting such  a search in a
       followup inspection.
6.9  INSTANT FILM CHEMICAL EXEMPTION (IFCE)
As a result of a petition from the Polaroid Corporation, EPA established an exemption for new chemical
substances used in or for the manufacture or processing of instant photographic and peel-apart film
articles.   To manufacture or  import a new chemical substance under the terms of the Instant Film
Chemical Exemption (IFCE), a manufacturer must submit an exemption notice when manufacture begins,
limit manufacture and processing of a new chemical substance to the site(s) listed in the IFCE notice, and
also comply with requirements to limit exposure to the new chemical substance.  A manufacturer is not
permitted to distribute in commerce or use a peel-apart film article containing a new chemical substance
until the manufacturer submits a PMN and until the 90-day review period for the notice has ended without
EPA having taken any action to prevent the distribution or use of the chemical.

A new chemical substance manufactured  under the terms of the IFCE will not be added to the TSCA
Inventory. However, a firm may elect to submit a PMN for a chemical covered by the exemption, and
the chemical will be placed on the Inventory after the notice review period ends and manufacturing begins
unless EPA takes action, such as by  issuing a TSCA Section S(e) or Section S(f) order.

The  submission requirements for the IFCE  notice are delineated  in  Table  6-2.   The regulatory
requirements for the IFCE are summarized in Table 6-12.

6.9.1 INSPECTION OBJECTIVES
The inspection objectives to determine compliance with the IFCE are as follows:
TSCA 55 5/8 Inspection Guidance            6-57                              November 1992
-------
z
o
00

                                              TABLE 6-12 INSTANT FILM CHEMICAL EXEMPTION (IFCE)
                                                                                                                                           1
              723.175(a)(l)
              723.175(e)
723.175(e)(l)
723.175(e)(2)
723.175(e)(3)
723.175(e)(4)
723.175(e)(5)
723.175(e)(6)
723.175(e)(7)
723.175(e)(8)
723.175(e)(9)
723.175(e)(10)
              723.175(f)
              723.175(f)(D
              723.175(0(2)(i-iii)
              723.175(0(3)
              723.175(g)
                    47 PR 24317
                    June 4, 1982
                    47 FR 24317-18
                    June 4, 1982
                    47 FR 24319
                    June 4, 1982
                    47 FR 24319
                    June 4, 1982
To qualify for exemption:

•  The new chemical substance must be used in or for the manufacture or processing of an instant
   photographic and peel-apart film article.
All manufacturing, processing, and use operations must be performed in a special production area
(SPA) under specified conditions, including:

   Exposure limits
   Respiratory protection
   Monitoring
   Engineering controls and exposure safeguards
   Training, hygiene, and work practices
   Personal protection devices
   Caution signs
   Procedures  for removal of a hew chemical substance for storage or transportation
   Labeling
   Exposure limits and monitoring apply to areas immediately adjacent to the SPA.
A manufacturer or processor may incorporate a wet mixture into a photographic article or an instant
photographic or peel-apart film article outside the SPA under specified conditions, including:
                                         • Engineering controls and exposure safeguards
                                         • Training, hygiene, and work practices
                                         • Personal protection devices.
A manufacturer may incorporate a photographic film article into an instant photographic or peel-apart
film article outside the SPA as long as he takes the same precautions required by 723.175(f).
-------
3
5
Ul

00
TABLE 6-12 INSTANT FILM CHEMICAL EXEMPTION (IFCE) (Continued)
w$m
723.175(h)

723.175(h)(l)
723.175(h)(2)
723.175(h)(3)
723.175(0(1)

723.175(i)(l)(0
723.175(i)(l)(ii)
723.175(i)(l)(iii)
723.175(i)(l)(iv)
723.175(i)(l)(v)
723.175(i)(l)(vi)
723.175(i)(l)(viii)
723.175(i)(l)(ix)
723.175(i)(l)(vii)
723.175(i)(l)(viii)
723.175(i)(l)(ix)
723.175(i)(l)(x)
723.175(1)

723.175(m)

|H |»ihUcat!on
47 FR 24319-20
June 4, 1982



47 FR 24320
June 4, 1982












47 FR 24321
June 4, 1982
47 FR 24321
June 4, 1982
^ * ' * ; ' Requirements
Additional conditions of processing outside the SPA regulate:

• Release to land of process waste
• Release to water of wastewater or discharge
• Release to air of process emissions.
Notice must include:

Name of manufacturer and sites and locations where manufacturing and processing occur
Chemical identification and structure
Impurities
Physical-chemical properties
Byproducts
Anticipated maximum annual production volume
Identity of articles) containing new chemical substance
Description of methods used to control and treat releases to water
Health and environmental effects test data
Identity of the article that will contain the new chemical substance
Description of the methods used to control and treat wastewater or discharge
Certification.
Amendment and repeal of substantive terms of the exemption requires formal rule-making
procedures.
Prohibition of use of the exemption does not require formal rule-making procedure.

                                                                               JP
                                                                                                          I
                                                                                                          IP
                                                                                                          r
-------
 TSCA Section 5 Inspections	Chapter Six
   •   To verify the accuracy and completeness of the information contained in the IFCE notice
   •   To verify adherence by the manufacturer or processor to the IFCE.

 The inspector should note that the IFCE recordkeeping requirements specify not only the retention of
 production records, but also the retention of exposure monitoring records, training and exposure records,
 and treatment records.  Any failure to keep these records is a violation of 40 CFR §723.175(j).  The
 supporting records for the IFCE may  be consolidated by the company  in one file or  they may be
 distributed at different production sites. The inspector should encourage the company to consolidate these
 records for review when arranging the inspection.

 The inspector should not simply accept at face value the IFCE records as provided by the facility. S/he
 should identify all of the names and designations for the subject chemical substance and note its mention
 in any other records and data reviews, as well as watch for its potentially illegal  manufacture, sale,
 storage, or use during the plant tour.

 The inspector should note that under 40 CFR §723~.175Q)(2) the manufacturer or processor must make
 these records available to EPA within IS working days-of receipt of a written request by the Director of
 the Office of Pollution Prevention and Toxics.

 In accordance with 40 CFR §723.175(1), EPA may amend or repeal any substantive terms of the IFCE
 through formal rule-making procedures. Pursuant to 40 CFR  §723.175(m), EPA may also prohibit the
 manufacture, processing, distribution, use, or disposal of any new chemical substance under the terms
of the IFCE if it makes the determination that any one  of these activities may present an unreasonable
risk of injury to health or the environment. Unlike the amendment or repeal, prohibition does not require
a rule.

6.93 INSPECTION GUIDELINES
Before the inspection, the inspector should review a copy of the IFCE notice, a copy of the IFCE Federal
Register notice, and copies of correspondence with EPA regarding the exemption. At the plant site, the
inspector should  verify the information contained in these documents by  reviewing company records,
interviewing company employees, and touring the facility.
November 1992                              6-60            TSCA §§ 5/8 Inspection Guidance
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Chapter Six         	TSCA Section 5 Inspections
The following elements generally constitute the ICFE components that require compliance verification
during an inspection:

   •   Conditions of manufacture and processing in the special production area (SPA)
   •   Conditions of processing outside the SPA
   •   Environmental release and waste treatment
   •   Manufacturer and sites
   •   Chemical identification and structure
   •   Impurities
   «   Physical-chemical properties
   •   Byproducts
   •   Production volume
   •   Health and environmental effects testing data
   •   Identity of the article'
   •   Release to water.

The following guidelines should assist the inspector in assessing compliance with the above-listed elements
ofthelFCE:

   •   Verifying  conditions of  manufacture and  processing  in the SPA.  Under  the IFCE,  all
       manufacturing, processing, and use operations involving the new chemical substance must be
       performed in an SPA under specified conditions until  the new chemical substance has been
       incorporated into a wet mixture, photographic article, or instant photographic peel-apart film
       article.   The manufacturer must take precautions in the SPA, which include the following, to
       safeguard against worker exposure:
       -  Exposure limits
       -  Respiratory protection
       -  Monitoring (by means of air samples) to ensure compliance with the exposure limits
                    t
       -  Engineering  controls and exposure safeguards (e.g.,  isolation, enclosure, local  exhaust
         ventilation, and dust collection)
       -  Training, hygiene, and work practices
       -  Personal protection devices
TSCA 55 5/8 Inspection Guidance            6-61                               November 1992
-------
TSCA Section 5 Inspections	Chapter Six

       -  Clearly posted caution signs

       -  Procedures for removal of a new chemical substance for storage or transportation

       -  Labeling of the chemical substance

       -  Exposure limits for and periodically monitoring areas immediately adjacent to the SPA

       A vital aspect of the IFCE inspection will be to determine if the manufacturer has established these
       protective and safety measures and  if the manufacturer uses them actively and effectively during
       the production, processing, and handling of the new chemical substance. To determine compliance
       with most of the conditions delineated above, the inspector should visit the site(s) when the subject
       chemical substance is actually being manufactured or processed.  The inspector can spot the use
       of engineering controls, personal protection devices (such as protective clothing or equipment,
       chemical-resistant coveralls, protective eyewear, and gloves), caution signs, and labeling, as well
       as  adherence to hygienic standards  and worker practices.  In a walk-through of the facility, the
       inspector can document noncompliance through direct observation.

       If the new chemical substance has been manufactured, but not during the on site inspection, the
       inspector should interview employees (and others, if necessary) to ascertain whether the required
       protective clothing devices were in full use during manufacture. Although production may not be
       under way during the site visit, the  inspector can still check compliance with the exposure limits
       by means of the monitoring records. The inspector should note that the company is required to
       keep monitoring data for each monitoring location.

   •   Verifying conditions of processing outside the SPA.  The manufacturer may incorporate either (1)
       a wet mixture into a photographic article or an instant photographic or peel-apart film article or
       (2) a photographic article into an instant photographic or peel-apart film article outside the SPA
       under conditions similar to those required of the manufacturer  inside the SPA.  The inspector
       should assess the conditions of processing outside the SPA in the same way s/he evaluates the
       conditions within the SPA. When touring the facility, the inspector should determine whether the
       manufacturer is using or implementing the following:

       -  Engineering controls and exposure safeguards

       -  Training, hygiene, and work practices

       -  Personal protection devices.

       If the inspector is unable to observe the new chemical substance being manufactured on site, s/he
       should interview employees (and others, if necessary) to ascertain compliance with the above-listed
       requirements.

   •   Verifying envirop^fffflj release yd w ftfte treatment. Another condition of the IFCE specifies that
       any wastes containing the new chemical substance that are released to land, water, and  air must
       be appropriately treated and/or disposed of. For specific details on waste treatment, the inspector
       can check the IFCE notice, which includes such information. The inspector should review with
       company officials the waste treatment or disposal activities.  The inspector should observe these
       activities during a walk-through of the facility. If during the inspection the inspector suspects or
November 1992                              6-62             TSCA $9 5/8 Inspection Guidance
-------
Chapter Six	TSCA Section 5 Inspections

       finds problems with the treatment or disposal of the wastes containing the new chemical substance,
       s/he should contact the appropriate Regional staff responsible for those specific activities.  For
       example,  if the inspector suspects that the manufacturer is disposing of  hazardous solid wastes
       containing the chemical substance without using proper procedures, the inspector should document
       the situation and notify Regional staff responsible for the Resource Conservation and Recovery
       Act (RCRA) program.

   •   Verifying chemical identification and structure. The manufacturer is required to classify the new
       chemical substance as either a Class 1 or a Class 2 substance, or as  a polymer.  The inspector
       should compare die identity and  structure of the- chemical substance by reviewing chemical
       composition or formulation data and product literature.  The inspector should review structural
       diagrams representing the chemical substances, if available.

   •   Verifying impurities.   The manufacturer  is required to identify impurities that are reasonably
       expected to be present in the new chemical substance by name, by CAS Registry Number, by
       class, and by process or source. The notice must also estimate the maximum percent (by weight)
       of each impurity in the new chemical substance and the percent of unknown impurities present.
       The inspector should also review these same items to verify die impurities in  die new chemical
       substance. The inspector should document any discrepancies between the information in the IFCE
       notice and the company's records and obtain copies of supporting data  obtained  for followup with
       EPA Headquarters.

   •   Verifying physical-chemical properties.  Since the physical-chemical properties should have been
       reviewed  by EPA Headquarters,  the inspector should simply check the MSDS or chemical
       information provided by the company.  Any discrepancies should be documented for followup with
       OPPT.

   •   Verifying byproducts.  In the notice, the manufacturer must identify die name, CAS  Registry
       Number (if available), and the volume  of each byproduct that would  be  produced during
       manufacture of the new chemical substance.  The inspector should review the product diagram,
       product process schematic, and/or process information to confirm the  byproducts. The inspector
       should document any discrepancies for inclusion in the inspection report.

   •   Verifying production volume.  Through a review of general production,  inventory, and sales
       records, the inspector should verify that the manufacturer  has included in die  IFCE notice  both
       an estimate of the anticipated maximum annual production volume and me initial commercial
       production date. The inspector should document any discrepancies for inclusion in die inspection
       report.

   •   Verifying health and environmental effects testing data.  The inspector  should review the  files
       containing the health and environmental effects testing data.  The manufacturer must submit to
       EPA as part of the IFCE notice all health and environmental effects testing data in die submitter's
       possession or control  and descriptions of other data that are known to or are  reasonably
       ascertainable by the submitter and that concern the health  and environmental effects of die new
       chemical substance.  To verify that these critical data were generated or available prior to the
       IFCE notice submission, the inspector should confirm that the  dates of such  submitted data or
       information are reliably documented.
TSCA 55 5/8 Inspection Guidance            6-63                              November 1992
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TSCA Section 5 Inspections	Chapter Six

      The inspector should note that a search for health and environmental effects testing data is very
      difficult and  time consuming (i.e., it can take up to  2 to 4 days).   Therefore,  if during an
      inspection  the  inspector suspects the company has not submitted  the required health and
      environmental effects testing data, s/he may want to consider such a search in a second fbllowup
      inspection.

   •  Verifying identity of the article. The inspector should confirm the type of instant photographic
      film artide(s) or peel-apart film articles) that contains the new chemical  substance as it is
      described in the IFCE notice. The inspector can do this by observing manufacture of the article,
      looking at the manufactured article, or reviewing product literature.

   •  Verifying release to water.  The inspector should review the methods used to control and treat
      wastewater or discharge released to a Publicly-Owned Treatment Work (POTW) or any other
      receiving body  of water.  The manufacturer must provide this information, as well as the name
      of the POTW or the receiving water body to which the wastewater is discharged,  in the IFCE
      notice.  The inspector can verify this information by reviewing the facility's permit  issued under
      the National Pollutant Discharge Elimination System (NPDES) permit either by the State or EPA,
      or its permit issued under the Pretreatment Program by the POTW. The inspector  may want to
      notify the Regional staff responsible for the NPDES program (if the facility discharges directly
      to a receiving water body) or for the municipal pretreatment program (if the facility discharges
      to a POTW).
6.10  ZERO EXPOSURE

Under TSCA Section S(h)(5), EPA may exempt any chemical substance that "(A) exists temporarily as

a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical
substance, and (B) to which mere is no, and will not be, human or environmental exposure." This

exemption requires mat an application be filed with EPA.
November 1992                              6-64            TSCA S§ 5/8 Inspection Guidance
-------
 Chapter Seven	TSCA Section 8 Inspections

 Chapter Seven

 TSCA Section  8 Inspections
7.0  TSCA SECTION 8 INSPECTIONS	  7-1

7.1  INTRODUCTION  	  7-1

7.2  SECTION 8(a)	  7-4

    7.2.1 PRELIMINARY ASSESSMENT INFORMATION RULE (PAIR) 	  7-4

        7.2.1.1 INSPECTION OBJECTIVES	  7-5
        7.2.1.2 PHASE 1 INSPECTION	  7-6
        7.2.1.3 PHASE 2 INSPECTION	  7-15

    7.2.2 COMPREHENSIVE ASSESSMENT INFORMATION RULE (CAR)	  7-16

        7.2.2.1 INSPECTION OBJECTIVES	  7-18
        7.2.2.2 PHASE 1 INSPECTION (TO BE COMPLETED)	  7-18
        7.2.2.3 PHASE 2 INSPECTION	  7-18

7.3  SECTION 8(a): INVENTORY UPDATE RULE (IUR)	  7-21

    7.3.1 INSPECnON.OBJECnVES 	  7-23
    7.3.2 PHASE 1 INSPECTION 	  7-23
    7.3.3 PHASE 2 INSPECTION 	  7-24

7.4  SECTION 8(c): ALLEGATIONS OF SIGNIFICANT ADVERSE HUMAN
    HEALTH OR ENVIRONMENTAL EFFECTS  	  7-26

    7.4.1 INSPECTION OBJECTIVES 	  7-28
    7.4.2 INSPECTION GUIDELINES 	  7-30

7.5  SECTION 8(d): HEALTH AND SAFETY STUDIES	  7-32

    7.5.1 INSPECTION OBJECTIVES 	  7-34
    7.5.2 INSPECTION GUIDELINES 	  7-34

7.6  SECTION 8(e): NOTIFICATION OF SUBSTANTIAL RISKS  	  7-35

    7.6.1 INSPECTION OBJECTIVES 	  7-39
    7.6.2 INSPECTION GUIDELINES 	  7-39
TSCA SS 5/8 Inspection Guidance         7-i                       November 1992
-------
TSCA Section 8 Inspections                                       Chapter Seven
                           LIST OF FIGURES
                                                                Page

FIGURE 7-1  ORGANIC CHEMICAL MANUFACTURE SCHEMATIC -
          BENZOIC ACID AND BENZALDEHYDE 	 7-8
FIGURE 7-2  ORGANIC  CHEMICAL   MANUFACTURE   SCHEMATIC
          PERCHLOROETHYLENE-CHLORINATION
          OF CHLORINATED HYDROCARBONS  	 7-9
FIGURE 7-3  HOW TO CALCULATE QUANTITIES OF CHEMICAL
          PROCESSED BY PROCESS CATEGORY	 7-10
FIGURE 7-4  HOW TO CALCULATE WORKER EXPOSURE
          HOURS AND WORKER HOURS 	 7-12
FIGURE 7-4  HOW TO CALCULATE WORKER EXPOSURE
          HOURS AND WORKER HOURS (continued)	 7-13
FIGURE 7-5  HEALTH AND SAFETY STUDIES	 7-36
                           LIST OF TABLES

TABLE 7-1  SUMMARY OF SECTION 8 REPORTING AND
          RECORDKEEPING REQUIREMENTS	 7-2
TABLE 7-2  SECTION 8(c) ALLEGATIONS THAT MUST BE RECORDED	  7-27
TABLE 7-3  SECTION 8(c) RECORDKEEPING REQUIREMENTS	  7-29
TABLE 7-4  SECTION 8(d) REPORTING REQUIREMENTS	  7-33
TABLE 7-5  SECTION 8(e) INFORMATION THAT MUST BE REPORTED	  7-38
November 1992                      7-ii         TSCA 55 5/8 Inspection Guidance
-------
 Chapter Seven	TSCA Section 8 Inspections
                            7.0 TSCA SECTION 8 INSPECTIONS

 7.1  INTRODUCTION
 This chapter contains  background information  and guidance to assist the inspector in conducting
 inspections for the reporting and recordkeeping requirements for existing chemicals under the Toxic
 Substance Control Act (TSCA) Section 8.  The inspector should keep in mind that for the purposes of
 Section 8  the terms "chemical substance,"  "mixture," and "articles" ace defined within the applicable
 regulations. These definitions have been included within the text to assist the  inspector in understanding
 to what substances or  products the regulations apply.  The Section 8 reporting and recordkeeping
 requirements are summarized in Table 7-1.

 The various sections of this chapter describe  how the  inspector  can determine if  a  firm  that is
 manufacturing or importing (and in some cases processing) an existing chemical is complying with the
 applicable reporting or recordkeeping requirements as follows:

  •  Section 7.2 - Preliminary Assessment Information Rule (PAIR) and Comprehensive Assessment
     Information Rule (CAIR) reporting [TSCA Section 8(a)]
  •  Section 7.3 - Inventory Update Rule (IUR) reporting [TSCA  Section 8(a)]
  •  Section 7.4 - Recordkeeping for allegations of significant adverse human health or environmental
     effects [TSCA Section 8(c)J
  •  Section 7.5 - Reporting of health and safety  studies [TSCA Section 8(d)]
  •  Section 7.6 - Notification of substantial risks [TSCA Section  8(e)J.

Throughout the chapter, the inspector will find tips and examples  to help explain the interpretation and
application of the regulations. In addition, the tables found throughout the chapter provide summaries
of the regulations as a quick reference for the inspector.  However, the inspector should note that these
summaries are not intended to substitute for  the regulations published in the Code of Federal Regulations
and Federal Register, and thus the appropriate citations are included in these tables for the inspector's
use.

The  inspector should note that Section 8 inspections are generally done in conjunction with Section 5
inspections. This is because when the inspector is reviewing the general inventory of chemicals
TSCA 55 5/8 Inspection Guidance             7-1                               November 1992
-------
TABLE 7-1. SUMMARY OF SECTION 8 REPORTING AND RECORDKEEPING REQUIREMENTS
I
Switaoi •
8(a)
8(a)
PAIR

8(a)
CAR

8(a)
IUR
Ctatfon
40CFR704
SubpartB
40CFR
712.20

40CFR
704.11
704.206

40CFR
710.33
710.37
ttfetoe
Substance
•pacific
June 1982
(Substance
specific)
December
1988
(Substance
specific)
August-
December
1986
W» Require*
Manufacturers,
importers, and
processors
Manufacturers

Manufacturers,
importers, and
processors

Manufacturers
and importers
Itepwrttoft itecp&ranteBfe
• Dependent on chemical.
• 2-page report for each plant
manufacturing a chemical listed in
40 CFR 9712.30
• Cover latest corporate fiscal year
• Due 60 days from effective date.
• Chemical specific parts of 141 -page
report for each facility
manufacturing, importing, or
processing any chemicals listed in
40 CFR 704 Subpart D
• Report corporate fiscal year that
falls within CAIR coverage period.
• Initial and recurring (every 4 years)
reporting to TSCA Inventory
• Manufacture or import chemical in
the fiscal year prior to reporting
period.
RttonQteepin? ftatuireaiente
• Dependent on chemical.
• No recordkeeping requirement.

• Copies of all CAIR forms submitted
• Materials that verify the report, and
copies of all notices sent to customers
who distribute a listed substance.
• All TSCA Inventory data submissions
(kept for 4 years after reporting
period)
• Site-specific production records
• Records that verify small business
exemption.
-------
TABLE 7-1.  SUMMARY OF SECTION 8 REPORTING AND RECORDKEEPING
                  REQUIREMENTS (Continued)
Stttfeft
8(c)
8(d)
8(e)
' Of*** :
40 CFR 717
40 CFR 716
43 FR 11110
(Policy
Statement)
.Effect**
1983
1982
(Substance
specific)
Statute:
January
1977
Policy
Statement:
March
1978
WtwRwpdwd
Manufacturers
and certain
processors
Manufacturers,
importers, and
processors
Manufacturers,
importers,
processors, and
distributors
B^tMr^Rt^rtm^
• Records must be reported when
required by letter to firms or notice
in the Federal Register.
• Submit information within 60 days
after effective date of chemical
placed on 40 CFR 9716.120 list.
• 10-year continuing obligation to
report certain information.
• Substantial risk information reported
innnflHifitelv*
- Emergency - within 24 hours
(oral)
- Nonemergency - within IS
working days (written).
R«»rafc^ii*R^Mi«n*nfs
• Record of all allegations (the original
document and abstract).
• No recordkeeping requirement.
• No recordkeeping requirement.
                                                                            I
-------
 TSCA Section 8 Inspections	Chapter Seven
 manufacturoTor imported by the company under the Section 5 inspection (see Section 6.3 for additional
 details), the inspector can concurrently identity any chemicals being manufactured or imported that are
 subject to any of the Section 8 requirements.

 7.2  SECTION 8(a)
 TSCA  Section  8(a) grants EPA  the  authority  to require companies to  document  their  chemical
 manufacturing, importing, and processing activities. Under Section 8(a),  EPA may set recordkeeping
 and reporting requirements for specific chemicals. The Agency's most significant use of Section 8(a) has
 been the issuance of model rules that apply to multiple chemicals. Subpart B of 40 CFR Part 704 sets
 uui the chemical-specific reporting and recordkeeping requirements under Suction 3(a) of TSCA. EPA
 issued the PAIR  in June 1982 (40 CFR Part 712 Subpart B) and the CAIR in December 1988 (40 CFR
 Part 704 Subpart Q.  While the PAIR is the predominately used form, because of its comprehensiveness,
 it is anticipated that the CAIR will eventually replace the PAIR.  The following subsections describe the
 PAIR and CAIR rules.  (A copy of the PAIR form is found in Appendix 10).

 7.2.1  PRELIMINARY ASSESSMENT INFORMATION RULE (PAIR)
 The PAIR, found at 40 CFR 712 Subpart B,  is designed to gather information to support the preliminary
 stage of chemical assessment. All persons who manufacture or import in bulk any of the chemicals listed
 in 40 CFR §712.30 for commercial purposes are required to submit a PAIR report.  Also included as
 subject manufacturers are miners and oil refiners that apply any method of extraction, refinement,  or
 purification of a mined substance to make it marketable.  These maufacturers  are also required to report
 the manufacturing steps and uses of the extracted chemical. Processors are not subject to the PAIR.

The  following manufacturers and  importers are exempt  from reporting under the PAIR (40 CFR
 §712.25):
  • Companies that manufactured or imported the chemical substance, during the reporting period, only
    for scientific experimentation,  analysis, or research, including research or analysis for product
    development (i.e., R&D).
  • Companies that manufactured or imported less than 1,100 pounds (500 kilograms) of a chemical at
    a single plant site during the reporting period (small quantity exemption).
  • Small manufacturers or importers, defined as companies whose total annual sales taken together from
    all sites owned by the foreign or domestic parent company were below $30 million for the reporting
November 1992                              7-4             TSCA §§ 5/8 Inspection Guidance
-------
 Chapter Seven	TSCA Section 8 Inspections
     period, and who produced less than 100,000 pounds (45,400 kilograms) of the listed substance at
     the plant site.  However, the exemption does not apply to any chemical listed in 40 CFR §712.30
     designated by an asterisk.
  •  Companies that manufactured the chemical as a non-isolated intermediate,  an impurity,  or  a
     byproduct that was not used  or sold, or formed as described  in 40 CFR §710.4(d) (3) through (7).
With these exceptions, manufacturers and importers subject to PAIR must submit the two-page report for
each plant site manufacturing a chemical listed in 40 CFR §712.30. Information submitted for a chemical
substance or mixture must cover the respondent's latest complete corporate fiscal year as of the effective
date of the rule adding the substance  to PAIR.   In accordance with 40 CFR §712.30(c),  companies
generally have 60 days from the effective date to submit complete PAIR reports.

The elements of the PAIR report include:

  •  Quantity of chemical manufactured or imported for sale or use
  •  Quantity lost to the environment and in wastes
  •  Manufacturing processes and worker exposure
  •  Manufacturer products
  • Customer uses and products
  • Trade names
  • Customer's process categories.

7.2.1.1 INSPECTION OBJECTIVES
The inspection objectives  to determine  compliance with 40 CFR Part 712 are:

  • To verify the accuracy and completeness of information contained in the PAIR form (Phase 1)
  • To identify firms which have failed to submit a PAIR report for chemicals that are subject to PAIR
    (Phase 2).    '

The second phase of the  inspection (i.e., identify failure to submit a PAIR report) is usually done in
conjunction with the Section 5 general  inventory part of the inspection (discussed in Section 6.2.3). In
addition, a Section 4 (see Chapter 5) and Section 8(d) review  (see Section 7.5) will also normally be
conducted at this time.
TSCA 55 5/8 Inspection Guidance             7-5                              November 1992
-------
 TSCA Section 8 Inspections	Chapter Seven

 The inspector should be aware that no recordkeeping requirement exists for this rule.


 7.2.1.2 PHASE 1 INSPECTION

 The inspector should review official copies of the PAIR reports before the inspection. At the plant site,

 the inspector will verify the information contained in the PAIR report by reviewing company records,

 interviewing company employees, and touring the facility. The inspector should determine the applicable

 reporting period (i.e., the latest complete corporate fiscal year) and when reviewing the PAIR elements,

 ensure that these elements have been derived from the applicable period.


 The following guidelines should  provide assistance to the  inspector in  verifying the accuracy and

 completeness of the various elements of the PAIR report.
    Verifying Quantity of chemical manufactured. The inspector should review batch records, production
    records, manufacturing and process records, inventory records, invoices, and annual sales reports
    for the applicable reporting period.  If the reported figures were based on or derived from other
    information, the inspector should ask the company official to clarify the source of the figures.  Any
    significant  discrepancies (typically, greater man 20 percent) should be documented by copying
    pertinent records and/or obtaining a signed statement from the company official.

    Verifying quantity of chem'yp^ '"ported. The inspector should review invoices and shipping records
    for the applicable reporting period.  If the reported figures were based on or derived from other
    information, the inspector should ask the company official to clarify the source of the figures.  Any
    significant  discrepancies (typically, greater than 20 percent) should be documented by copying
    pertinent records and/or obtaining a signed statement from the company official.
  • Verifying flVWltity lost to the envfogpiqeju and in wastes.  The inspector should review monitoring
    records including emission (air) records, National Pollutant Discharge Elimination System (NPDES)
    permits, wastewater Discharge Monitoring Reports (DMRs), shipment and disposal records [e.g.,
    Resource Conservation and Recovery Act (RCRA) manifests], and EPCRA Section 313 reports for
    the applicable reporting period.  The inspector  should also tour the facility  and should check the
    points in the facility where discharges and releases occur and check that monitoring is actually taking
    place to verity that all monitoring records have been provided.  If the reported figures were based
    on or derived from other information, the inspector should ask the company official to clarify the
    source of the figures. Any significant discrepancies (typically, greater man 20 percent) should be
    documented by copying pertinent records and/or obtaining a signed statement from the company
    official.

  • Verifying Pfflufacturing  process^  ?niK worker  exposure.  The inspector  should  review the
    manufacturing processes and evaluate whether the manufacturer has correctly classified each unit
    process as enclosed, controlled release, or open.
November 1992                               7-6            TSCA 55 5/8 Inspection Guidance
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Chapter Seven	         	      	TSCA Section 8 Inspections
                                DEFINITIONS (40 CFR §712.28)
         Enclosed process is defined as a process which is designed and operated in a controlled
         manner to minimize release of the chemical. In this  category, onfy fugitive or routine
         releases  occur  and special measures  are  taken to  prevent worker exposure  and
         environmental contamination.  'Special measures* include procedures and equipment that
         are monitored and used to prevent worker exposure, and scrubbers and other recovery
         equipment employed to prevent environmental release.   Equipment with emergency relief
         venting would be included in this category, but routine venting would not.

         Controlled release process  is defined as a process operated in a  controlled manner to
         minimize release of the  chemical into  the workplace.    Releases  would generally be
         prescribed within limits, which may be dictated by government regulations or by  company
         guidelines.  If the chemical is vented or otherwise discharged outside the plant process, the
         process is a "controlled release' process. General space ventilation fans are not counted
         in this category.

         Open process is defined as a process in  which the chemical is routinely in direct contact
         with the atmosphere  (workplace or outside the plant) and no measures are taken to prevent
         release.  For example, reaction vats are open, the chemical is transported or stored in open
         containers, or the chemical is freely vented into the workplace.
    For each process category (i.e., enclosed, controlled release, and open), the inspector must verity
    the total quantity of chemical processed, the number of worker exposure hours, and the number of
    workers exposed for the applicable reporting period.

    To review the manufacturing processes, the inspector should tour the facility, reviewing each unit
    process and discussing  with the company representative any  questions or  issues that arise.
    Alternatively, if there is insufficient time for a tour, the inspector should request a facility process
    schematic or site layout plan, and review it with the company representative as to how each unit
    process was categorized for the PAIR report. (Sample process schematics for an organic chemicals
    manufacturer are given in Figures 7-1 and 7-2.)  The inspector should review production records,
    manufacturing operating procedures or  operating quality control procedures, and documentation of
    how the company calculated the total quantity of material  processed in each process category.  An
    example illustrating how this number should be calculated is presented in Figure 7-3.

    The inspector  should note  that  this facility tour or facility process review presents  an ideal
    opportunity for the inspector to discuss pollution prevention. The objective is to raise the company's
    awareness of pollution prevention and how it could be applied to the company's operations, not to
    provide technical advice. The inspector can do this by inquiring whether the company has examined
    any options for making open processes into enclosed processes.  In addition, the inspector could
    provide the name of the EPA contact person who can  provide additional pollution prevention
    information and materials to the company. A  list of EPA Region pollution prevention contacts is
    found in Appendix 6.

    To verify die worker exposure hours and number of workers for each process category, the inspector
    should review documentation of how the company calculated these numbers (if available). These
    numbers can sometimes be verified by reviewing production schedules, costing (or budget) figures,
TSCA Si 5/8 Inspection Guidance             7-7                               November 1992
-------
                         FIGURE 7-1


ORGANIC CHEMICAL MANUFACTURING SCHEMATIC - BENZOIC ACID
                    AND BENZALDEHYDE
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                                                                                 8
                          Limitations and New Source Performance
                          jrnent of the Organic Chemicals
                                   1975
-------
                                                     FIGURE 7-2


                                  ORGANIC CHEMICAL MANUFACTURE SCHEMATIC -
                       PERCHLOROETHYLENE-CHLOR1NATION OF CHLORINATED HYDROCARBONS
I
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                        Standards for the Significant Organic Product Segment of the Organic Chemicals
                        Manufacturing Point Source Category. U.S. EPA, November. 1975
-------
 TSCA Section 8 Inspections                    	                       Chapter Seven
                                    FIGURE 7-3

           HOW TO CALCULATE QUANTITIES OF CHEMICAL PROCESSED
                             BY PROCESS CATEGORY

                                     Example 1

   A company manufactures technical grade chemical x in four steps.
   350,000kg -* 350,000kg -* 350,000kg  ~* 200,000kg
     Open         Enclosed        Open         Enclosed

   The company would report:
      Enclosed                 350,000 kg
      Controlled release                0
      Open                    350,000 kg
                                     Example 2

  A company produces the same chemical in a reagent and technical grade with the following steps.


  Technical grade process:

  350,000 kg  -* 350,000 kg -* 350,000 kg  ~* 200,000 kg
     Open        Enclosed        Open         Enclosed

  Reagent grade process:

  650,000kg  -* 500,000kg ~* 500,000kg  -> 400,000kg
   Controlled      Controlled        Open          Open
    Release        Release

  The company would report:
      Enclosed                 350,000 kg
      Controlled release          650,000 kg
      Open                    850,000 kg

  (The open process amount is the total of the maximum quantity in the open process category from
  each grade.)
November 1992                           7-10          TSCA §9 5/8 Inspection Guidance
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 Chapter Seven _ TSCA Section 8 Inspections

     and employee time sheets and  records.   Examples  illustrating how  these numbers  should be
     calculated are given in Figure 7-4.  The inspector should note that any employees who have contact
     with the subject chemical (including the process supervisor, clean-up crew, and maintenance people)
     should be included in these calculations.

     Significant discrepancies (typically,  greater than  SO percent)  from reported values  should be
     documented with copies of the appropriate records and/or signed statements from company officials.
  •  Verifying on site use of the Chemical as a ^ffiffi*nt  This item applies to the use of chemicals at the
     facility as a reactant in the manufacture of another chemical substance, where the molecular structure
     of the chemical is altered by breaking chemical bonds or making new chemical bonds between the
     original substance and some other substance. The inspector should review the processing steps and
     determine  whether each step is classified as enclosed,  controlled release, or open.  The inspector
     should follow the procedures described for  manufacturing processes to verify the information
     provided in the PAIR report, except that in place of the production records, the inspector should
     review the processing records.
  •  Verifying on site nonrea.ffl"t nfi6 of the chemical.  This item applies to the nonreactant use of
     chemicals at the facility, including use as a cleaning solvent, dielectric fluid, emulsifier, or lubricant.
     The inspector should review each  use of the chemical and determine whether it is classified as
     enclosed, controlled release, or open. The inspector should follow the procedures described for
     manufacturing processes to verity the information provided in the PAIR report, except that in place
     of production records, the inspector should review documentation of how and where the chemical
     is being used.  This may be found in inventory  records.  If no documentation is available, the
     inspector may need to  obtain signed statements from company officials regarding the use of the
     chemical.

  •  Verifying on site preparation of products.  This item applies to the processing of the chemical at the
     facility into products for on site use or sale and includes all the steps the chemical passes through
     to produce the product.  This item also includes the quantity of chemical substance incorporated into
     a  mixture or article.  The inspector  should note that  this does not include manufacture of the
     chemical.  The  inspector should review  the processing steps and determine whether each step  is
     classified as enclosed, controlled release, or open.  The inspector should  follow the procedures
     described for manufacturing processes to verify the information provided in the PAIR report, except
     that hi place of the production records, the inspector should review the processing records.
                               i
  •  Verifying manufacturer's products.   This item requires the quantity of chemical prepared for
     industrial or  consumer (domestic  and export) use  that the customer will not further process.
     Industrial use means use by the manufacturing and service industries covered by the  Standard
     Industrial Classification (SIC) Codes. Consumer use means use primarily by the general population .
     Within these two categories, there are three types of products. The inspector must verify that each
     of the manufacturer's products has been correctly placed in one of the three product types: chemical
     substances or mixtures, articles  or products with no release,  or articles or products with some
     release.  The  three produced types are defined below.

     The inspector should verify that each product type has been correctly categorized and determine the
     total amount for each product type  by reviewing sales reports,  invoices, and shipping orders, and
     sales  brochures.   Sometimes die  company  will have  customer work  orders  containing  this
     information.  Any significant discrepancies (typically, greater than 20 percent)  from the reported
TSCA 55 5/8 Inspection Guidance             7-11                               November 1992
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TSCA Section 8 Inspections
                                Chapter Seven
                                     FIGURE 7-4

                 HOW TO CALCULATE WORKER EXPOSURE HOURS
                                AND WORKER HOURS

                                      Example 1

   A company manufactured 1,000,000 kg of a chemical substance in 1980.  It manufactured the
   chemical for all  12 months of the year and did so in an- enclosed process.

   In order to run the production line, 10 workers were present working 40-hour weeks; thus over
   the course of the year 20,800 worker-hours were used to run the production line.

   Over tne course  of the year, 12 different workers worked on the production of the chemical.

   The form would  then be filled out as follows:
Process category
Open
Controlled release
Enclosed
Quantity (kg)
0
0
1.000,000 kg
Worker-hours
0
0
20,800
Total workers
0
0
12
November 1992
7-12
TSCA M 5/8 Inspection Guidance
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 Chapter Seven
                      TSCA Section 8 Inspections
                                       FIGURE 7-4

                  HOW TO CALCULATE WORKER EXPOSURE HOURS
                           AND WORKER HOURS (continued)

                                        Example 2

   A company manufactured  1,000,XXX) kg of a chemical substance in 1980.  It manufactured the
   chemical for the entire year in a 24 hour/day process consisting of three steps in the open,
   controlled  release,  and open process categories.   The production line was shut down for
   maintenance for 2 weeks of the year.  The production line had three 8-hour shifts.  Each shift in
   step 1 required S workers, while 7 and 10 workers were needed per shift in steps 2 and 3,
   respectively. The total worker-hours required for each step follows:
Process category
Open (Step 1)
Controlled (Step 2)
Open (Step 3)
(Shifts/day x hours/shift
x workers x days/week x
weeks/year)
(3 x 8 x 5 x 7 x 50)
(3 x 8 x 7 x 7 x 50)
(3 x 8 x 10 x 7 x 50)
Worker-hours
42,000
58,800
84,000
   Analysis of the personnel records showed that a total of 75 individuals worked on the production
   of the chemical during 1980.  After examining the personnel records, the company was able to fill
   in the following table:
                  Process category
                   Open (Step 1)

                 Controlled (Step 2)

                   Open (Step 3)
              Total workers
                    21

                    19

                    25

                    75
   Note that workers are not double counted or split even though some jobs may require moving from
   one step of the process to another step of the same process. An employee working on both  step
   1 and step 2 is counted only in step 1 if s/he spends most of her/his time at that step. After adding
   together steps in the same process category, the company would report as  follows:
Process category
Open
Controlled release
Enclosed
Quantity (kg)
1,000,000
1,000,000
0
inrorker-uours
126,000
58,800
0
Total workers
56
19
0
TSCA 58 5/8 Inspection Guidance
7-13
November 1992
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TSCA Section 8 Inspections	Chapter Seven

     figures should be documented by copying pertinent records and/or obtaining a signed statement from
     the company official.
                               DEFINITIONS (40 CFR §712.28)
         Chemical substance or mixture is  defined as  a chemical, or mixture containing the
         chemical, that is used directly by the persons using the product (e.g., cleaners, paints, inks,
         deodorizers, solvents, etc.).   This  includes chemicals  or mixtures in. containers or other
         articles whose sole purpose is to release the chemical (e.g., cans of spray paint, ink pens,
         and other applications).

         Articles or products with no release are articles constructed to prevent human exposure to
         or release, to the  environment of the fhemcal sitbstance during normal use and storage
         (e.g., chemical coatings on internal components, and chemicals inside sealed articles such
         as thermometers and batteries).

         Articles or products with some release are articles whose material components are made of
         chemicals that come in direct contact with persons using the article, the atmosphere, land,
         or water (e.g., exposure can come from leaching, evaporation, or surface contact).  This
         includes  such articles as plastic containers, chemically  treated textiles, printed paper,
         coated appliances, etc.  If the chemical itself is sold in a bottle or other container it should
         be reported under 'Chemical substance or mixture,' not as an article.  Only the container
         itself is an article for purposes of this form; the substance it contains is not a component of
         the article.
    Verifying customers' uses and products.  This applies to how the customers are using or processing
    the manufacturer's chemical. The uses or products must also be categorized into the three product
    types described under the previous component: chemical  or mixture, article with some release, or
    article with no release.  Since the customer processing information is generally not readily available,
    the manufacturer probably estimated these numbers. Therefore, the inspector should discuss with
    the company official how the customers' uses and products were categorized and how the amount
    in each category was calculated.  The inspector should also consider reviewing the customer list or
    sales records with  the company official to ensure mat all customers and all  quantities sold to the
    customers were accounted for in the estimated numbers.

    Verifying piartot names  If the manufacturer or importer reported that more than 20 percent of the
    customers' uses or products are unknown, then the manufacturer must provide all the market or trade
    names for the chemical.  The inspector should verify these names through review of annual  sales
    reports, invoices, sales brochures, and product literature.  If there is a discrepancy (e.g., name that
    was not provided is found on invoices), the inspector should copy  all pertinent records and obtain
    a signed statement  from the company official clarifying the reason for the discrepancy.

    Verifying customers' process categories.  The manufacturer must attempt to provide an estimate of
    the process types (i.e., enclosed, controlled release, or open) used  by the customers to process the
    manufacturer's chemical.  Since this information is estimated by the manufacturer, the inspector
    should discuss it with the company official and document how  the reported numbers were derived.
November 1992                              7-14            TSCA H 5/8 Inspection Guidance
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Chapter Seven	TSCA Section 8 Inspections

The inspector should note that, in general, whenever there are any discrepancies between what was
reported and what is found during the review of records, the inspector should copy the appropriate
records indicating the discrepancy and include them as part of the inspection report (discussed in Chapter
10).

7.2.1 J PHASE 2 INSPECTION
The second phase of the inspection verifies that all chemicals  listed in the Chemical Information Rules
(40 CFR Part 712) that are manufactured or imported by the facility have been reported within the
timefrazie specified in the regulation (unless the manufacturer or importer is exempt).

Before the on site inspection, the inspector should identify any PAIR and IUR reports that have been
submitted by the company.  EPA  Headquarters provides the Regions with a Confidential Business
Information  (CBI)-summary of PAIR and IUR submittals derived from EPA databases (discussed in
Section 3.2.3).  The inspector may  also use the Chemicals in Commerce Information System (CICIS)
database and the IUR database [i.e., Chemical Update System (CUS)], if the Region has access, to
identify any suspect chemicals manufactured by the company which might be subject to PAIR reporting
but for which the company has not submitted PAIR reports.

During the inspection, the inspector should compare the company's current list of manufactured and/or
imported chemicals (see Section 6.2.3) against the latest Chemicals on Reporting Rules (CORR) list (see
Appendix 7). If the TSCA Inventory, IUR database, or the company's current inventory indicate the
production of a PAIR chemical for which a PAIR report was not submitted, the inspector should request
the company's records for the designated reporting period (which is found in the CORR list and in 40
CFR §712.30) to confirm that  the PAIR chemical was in fact manufactured or imported during that
period.  If the chemical  is subject to PAIR reporting and the company has not claimed an exemption
(listed  hi Section 7.2.1), the inspector should obtain copies of records that indicate the total volume of
chemical manufactured or imported and the estimated worker exposure hours. If the company is claiming
an exemption from PAIR reporting, the inspector should verify that the company meets the criteria listed
in 40 CFR §712.25 for exemptions as described below.
  • Verifying R&D exemption.  The inspector should  review R&D notebooks, reports, production
    records, and sales records to ensure that the chemical was in fact produced only for R&D purposes.
TSCA ftft 5/8 Inspection Guidance            7-15                              November 1992
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 TSCA Section 8 Inspections	Chapter Seven

   •  Small quantity exemption.  The inspector-should review production records for the company site
     being inspected for the designated reporting period. (For purposes of this exemption, a site means
     a contiguous property unit.  Property divided only by a public right-of-way is considered one site.
     There may be more than one plant on a single site.) If the site produces or imports more than 1,100
     pounds (500 kilograms), the site does not meet  the criteria for the small  quantity exemption.
     Records documenting the production in excess of 1,100 pounds at the site should be copied for
     inclusion in the inspection report.

   •  Verifying small manufacturer exemption.   The inspector should review production records  and
     annual sales reports or records for the whole company (i.e., all sites) for die reporting period. If
     the records indicate sales by the company of $30 million or more, or production of 100,000 or more
     pounds (45,400 or more kilograms) of the listed  chemical at the plant site being inspected, the
     company does not qualify  for the small  manufacturer  exemption.  Records documenting these
     exceedances should be copied for inclusion in the inspection report.

   •  Verifying chemical manufactured as non-isolated intermediate, an impurity, or byproduct.  The
     inspector should review the  manufacturing flow diagram for the product of which the listed chemical
     is a component (i.e.,  non-isolated intermediate,  impurity, or byproduct) if available.   If no such
     diagram is available, then the inspector should review the production records and sales records to
     ensure that the chemical was not manufactured and sold  and also ask company officials to explain
     and produce confirming documentation (if possible) describing where the chemical is a component
     in the manufacturing process.  The inspector should review sales records to verify that a chemical
     is manufactured as a non-isolated intermediate or impurity.
                                DEFINITIONS (40 CFR §712J)
         Non-isolated intermediate is defined as  an intermediate that is not intentionally removed
         from the equipment in which it is manufactured, including the reaction vessel, equipment
         that is ancillary to the reaction vessel, and any equipment through which the substance
         passes during a continuous flow process, but not including tanks or other vessels used for
         storage after manufacture.

         Impurity is defined as a chemical substance unintentionally present with another chemical
         substance or mixture.

         Byproduct is defined as any chemical substance or mixture produced without a separate
         commercial intent during the manufacture, processing, use, or disposal of another chemical
         substance or mixture.  [For the purposes of PAIR, the definition of byproduct also includes
         the description found in 40 CFR §710.4(d)(3) through  (7)].
7.2.2 COMPREHENSIVE ASSESSMENT INFORMATION RULE (CAR)

Certain Section 8(a) Information Gathering Rules are found in 40 CFR Part 704.  Subpart A of 40 CFR

Part 704 specifies general reporting and recordkeeping provisions for Section 8(a) Information Gathering

Rules. Subparts C and D of 40 CFR 704 address CAIR and list the 19 chemicals currently subject to

the rule.  PAIR and CAIR differ not only in length (2- page and 141-page reports respectively, though
November 1992                             7-16            TSCA $9 5/8 Inspection Guidance
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 Chapter Seven	TSCA Section 8 Inspections

 ]only certain questions are required for specific chemicals), but also in application.  While PAIR applies

 only to manufacturers and importers, CAIR covers manufacturers, importers, and processors. The design

 of the CAIR form enables EPA to use one form for many TSCA Section 8(a) reporting industries, thereby
 increasing EPA's ability, and decreasing the necessary time and energy, to capture relevant information.


 The following manufacturers, importers, and processors are exempt from reporting under CAIR (40 CFR

 §704.5):
  •  Companies that manufacture, import, or process small quantities of the CAIR chemical solely for
     R&D

  •  Companies that are small manufacturers, importers, and processors.  However, the definition of
     "small manufacturer" differs from PAIR and also applies to importers and processors.   A small
     manufacturer under CAIR manufactures, imports, or processes less than  100,000 pounds (45,400
     kg) per year at any individual site, and has total annual sales of less than $40 million when combined
     with those of its parent company.  Also, a manufacturer, importer, or processor with total annual
     sales of less than $4  million is exempt regardless  of the amount of listed chemical produced,
     imported, or processed (40 CFR §704.3)

  •  Companies that manufacture, import, or process the chemical solely as a non-isolated intermediate,
     an impurity, or a byproduct

  •  Companies that solely repackage the chemical.

  •  Companies that have previously used a CAIR reporting form to submit information about a substance
     subject to CAIR  to  EPA, or  another  Federal  agency,  are partially  exempt  from reporting
     requirements.


With the CAIR reporting form, EPA can tailor data requests to meet its specific needs for particular

information on a chemical. The CAIR specifies the time period during which the reportable activity must

have taken place.  To determine the period during which reportable activity has taken place to trigger

reporting requirements, each facility should:
  • Determine which corporate fiscal years fall completely within any CAIR-designated coverage period
    (listed in the matrix in 40 CFR §704.225)

  • Determine whether it engaged in an activity subject to that CAIR listing during any of those fiscal
    years.
Facilities should report activities that took place during the most recent  coverage period  (40  CFR

§704.214).
TSCA 5§ 5/8 Inspection Guidance            7-17                              November 1992
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 TSCA Section 8 Inspections	.	Chapter Seven
 The CAIR fbrnfcontains 10 different classes of information:

  • General manufacturer, importer, and processor information
  • Manufacturer, importer, and processor volume and use
  • Processor raw material identification
  • Physical/chemical properties
  • Environmental fate
  • Economic and financial information
  • Manufacturing and processing information
  • Residual treatment, generation, characterization, transportation, and management
  • Worker exposure
  • Environmental release.

 Respondents must keep a copy of all CAIR forms submitted to the Agency for 3 years.  Also, materials
 that verify the report and copies of all notices sent to, and return receipt from, customers of those who
 distribute a listed substance under a trade name must also be retained (40 CFR §704.11).

 7.2.2.1  INSPECTION OBJECTIVES
 The inspection objectives that determine compliance with 40 CFR 704 Subpart C are:
  • To verify the accuracy and completeness  of information provided in the CAIR form (Phase 1)
  • To identify firms that have failed to submit a CAIR report for a chemical subject to CAIR (Phase
    2).

7.2.2.2  PHASE 1 INSPECTION (TO BE COMPLETE!))
7.2.2J  PHASE 2 INSPECTION
The second phase of the inspection verifies that all chemicals listed in 40 CFR Pan 704 (i.e., subject to
CAIR reporting) that are manufactured, imported, or processed by the facility have been reported within
the timeframe specified in the regulation (unless the manufacturer, importer, or processor is exempt).

Before the on site inspection, the inspector should identify any CAIR reports mat have been submitted
by the company. These CAIR reports can be obtained from EPA Headquarters through an enforcement
request as discussed in Section 3.2.4.  The inspector may  also use the CICIS database and the IUR
November 1992                             7-18            TSCA 55 5/8 Inspection Guidance
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 Chapter Seven	TSCA Section 8 Inspections

 database (i.e., CUS), if the Region has access, to identify any suspect chemicals manufactured by the

 company which might be subject to CAR reporting but for which the company has not submitted CAIR

 reports.


 During  the inspection, the inspector should compare the company's  current list of manufactured,

 imported, or processed chemicals (see Section 6.2.3) against the latest CORR list (see Appendix 7).  If

 CICIS, IUR database, or the company's current inventory indicate the production of a CAIR chemical

 for which a CAIR report was not submitted, the inspector should request the company's records for the

 designated reporting period (which is found in the CORR list and in 40 CFR §704.223) to confirm that

 the CAIR chemical was in fact manufactured, imported, or processed during that period.  If the chemical

 is subject to CAIR reporting and the company is not subject to an exemption (listed in Section 7.2.2),

 the inspector should obtain copies of records that indicate the total volume of chemical manufactured,

 imported,  or  processed and the estimated worker exposure  hours.  If the  company is  claiming an

 exemption from CAIR reporting, the inspector should verify that the company meets the criteria listed

 in 40 CFR §704.5 and §704.210 for exemptions as described below.
  • Verifying R&D exemption.  The inspector should review R&D notebooks, reports, production
    records, and sales records to ensure that the chemical was in fact produced only for R&D purposes.

  • Verifying small manufacturer exemption.  The inspector should review production records and
    annual sales reports or records for the whole company (i.e., all sites) for the reporting period.  If
    the records indicate sales by the company of $40 million or more, or production of 100,000 or more
    pounds (45,400 or more kilograms) of the listed chemical at the plant site being inspected, the
    company does not qualify for the small manufacturer exemption.   Records documenting these
    exceedances should be copied for inclusion in the inspection report.
                Small Manufacturer and Small Processor Exemption  Criteria
                                 (40 CFR 1704.3 and §704.203)
         If the company's total sales combined with its parent company's sales are between  $4
         million and $40  million, the company must submit CAIR reports for manufacture.
         importation, or processing of 100,000 pounds or more of each particular chemical at any
         individual site.

         If the company's total annual sales combined with the parent company's sales are less than
         $4 million, then the company is  exempt from CAIR  reporting as a small manufacturer.
         importer, or processor regardless of the quantity of substance manufactured.
TSCA §§ 5/8 Inspection Guidance            7-19                             November 1992
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TSCA Section 8 Inspections   	Chapter Seven

  •  Verifviffg chemical manufactured  as  non-isolated intermediate,  imparity, or byproduct.  The
     inspector should review the manufacturing flow diagram for the product of which the listed chemical
     is a component (i.e., non-isolated intermediate, impurity, or byproduct) if available.  If no such
     diagram is available, then the inspector should review the production records and sales records to
     ensure that the chemical was not manufactured and sold and also ask company officials to explain
     and produce confirming documentation (if possible) describing where the chemical is a component
     in the manufacturing process. The inspector should review sales records to verify that  a chemical
     is manufactured as a non-isolated intermediate or impurity.
                                DEFINITIONS (40 CFR $704.3)
         Non-isolated intermediate is defined as an intermediate that is not intentionally removed
         from the equipment in which it is manufactured, including the reaction vessel, equipment
         that is ancillary to the reaction vessel, and any equipment through which the  substance
         passes during a continuous flow process, but not including tanks or other vessels used for
         storage after manufacture.  Mechanical or gravity transfer through a closed system is not
         considered intentional removal, but storage or transfer to shipping containers 'isolates' the
         substance by removing it from the process equipment in  which it is manufactured.

         Impurity is defined as a chemical substance unintentionally present with another chemical
         substance or mixture.

         Byproduct is defined as any chemical substance or mixture produced without a separate
         commercial intent during the manufacture, processing, use, or disposal of another chemical
         substance or mixture.
  • Verifying repackager exemption. The inspector should review facility operating procedures and walk
    through the plant and repackaging areas to verify that the chemical  is only being transferred to
    another container for purposes of sale.
                               DEFINITION (40 CFR §704.203)
         Repackager is defined as a person who buys a CAIR substance or mixture, removes the
         substance  or mixture from  the  container in  which it was bought, and transfers this
         substance, as is, to another container for sale.
    Verifying compapw previously submitted data.  The inspector should review copies of CAIR forms
    previously submitted by the facility to EPA or another Federal agency to verify that the facility is
    subject to a partial exemption from current reporting requirements for the chemical and the site. The
    previously submitted report must have covered a complete corporate fiscal year that ended no more
    than 3 years before the effective date of the current reporting requirements for the chemical and the
    data must be accurate.  The inspector should verify that the facility submitted a completed Section
November 1992                               7-20            TSCA 55 5/8 Inspection Guidance
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Chapter Seven	TSCA Section 8 Inspections
     1 of the CAIR reporting form and signed the certification in Section 1 that pertains to the use of the
     exemption.
7J SECTION 8(a): INVENTORY UPDATE RULE (IUR)
TSCA Section 8(a) requires EPA to maintain and update the TSCA Inventory of existing chemical
substances. The purpose of the TSCA Inventory is to index current existing chemicals in commerce.
The Inventory is a living document that EPA updates through involved processes of adding and deleting
listed chemicals. When a new chemical has successfully completed review under the TSCA Section 5
Premanufacture Notice (PMN) process and the PMN submitter issues a Notice of Commencement (NOC)
of non-exempt commercial manufacture or import, EPA adds this chemical to the Inventory   If a
chemical is not currently produced by any manufacturers, EPA removes the chemical from the Inventory
through the delisting process.

In 1986, EPA published the IUR (40 CFR 710 Subpart B).  IUR requires manufacturers and importers
of chemicals on the TSCA Chemical Substances Inventory to report current data on chemical identity,
production volume,  plant site, and site-limited status (unless exempt).   To be subject to reporting
requirements  under Section 8(a), a person must manufacture at,  or import to,  any single site 10,000
pounds (4,540 kilograms) or more during the latest complete corporate fiscal year immediately prior to
the reporting  period.  The  initial 120-day reporting period lasted  from August 25,  1986, to December
23, 1986. The  succeeding reporting periods last for 120 days (August 25 to December 23)  and occur
every 4 years (since  1986).  However, due to  a reporting extension, the 1990 reporting period was
extended to February 21, 1991.
                                            TIPS
 For the purposes of the reporting requirement, the site for an importer is the site of the operating
 unit within the person's organization that is directly responsible for importing the substance and
 that controls the import transaction. In some cases, the import site may be the organization's
 headquarters.                                         	
The following facilities are exempt from IUR reporting (40 CFR §710.28 and 710.29):
  • Producers of less than 10,000 pounds (4,540 kilograms) of substance at a particular site during the
    corporate fiscal year preceding the reporting period
TSCA 39 5/8 Inspection Guidance            7-21                             November 1992
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 TSCA Section 8 Inspections	Chapter Seven
  •  Small nffanufacturers under the definition of the rule (see Section 7.3.3).

 The following activities are exempt from IUR reporting (40 CFR §710.30):

  •  Production of a substance solely for R&D
  •  Import of a substance as part of an article
  •  Manufacturing a substance as an impurity, byproduct, non-isolated intermediate, or incidental to
     another operation or upon end use of another substance or mixture.

 Finally, the following substances are exempt from reporting under the IUR (40 CFR §710.26):

  •  Certain polymers,  inorganic substances, microorganisms,  and naturally occurring substances.

 A chemical substance that falls into one of the exempt categories must still be reported if it is the subject
 of a rule proposed or promulgated under Section 4, 5(a)(2), 5(b)(4), or 6 of TSCA, of an order in effect
 under Section 5(e) or 5(f) of TSCA, or of relief that has been granted under a civil action under Section
 5 or 7. (The inspector should check CORR to verify the status of a chemical for these types of regulatory
 actions.)

The elements of the IUR report include:

  •  Chemical identity
  •  Production volume
  •  Plant site
  •  Site-limited status.

Manufacturers and  importers must maintain the following records:
  • All Inventory data submissions and records that document the information in the submission, for 4
    years beginning with effective date of reporting period.
  • Production or import records to verify a reporting exemption because the production or importation
    is less than 10,000 pounds (4,540 kilograms).
November 1992                               7-22            TSCA §8 5/8 Inspection Guidance
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 Chapter Seven	TSCA Section 8 Inspections

 7.3.1  INSPECTION OBJECTIVES

 The inspection objectives to determine compliance with Section 8(b) are:


   •  To verify the accuracy and completeness of information submitted in the IUR form (Phase 1)

   •  To identify chemicals reported on the IUR form that are not on the TSCA 8(b) Inventory (Phase 1)

   •  To identify firms that have failed to submit the IUR (Phase 2).


 7.3.2  PHASE 1  INSPECTION

 The icspsctor should review official copies of the IUR reports before the inspection.  At the plant site,

 the inspector will  verify the information contained in the IUR report by reviewing company records and

 interviewing company employees.


 The following guidelines  should provide assistance to the inspector in verifying  the accuracy and

 completeness of the various elements of the IUR  report.
  •  Verifying production volume.  The inspector should review the production records for the subject
     chemical for the applicable reporting period (i.e., latest complete corporate fiscal year prior to
     August 25,  1990) to verify that the production numbers reported in the IUR report are accurate.
     Any discrepancies (greater than 10 percent) should be documented by copying the pertinent records
     and/or obtaining a signed statement from the company official.

  •  Verifying plant site. The inspector should verify that the production records that are being reviewed
     for the chemicals reported on the IUR are from the site of manufacture of the reported chemicals.
  • Verifying ff'fft-1'""^ status.  If a company has listed a chemical or chemicals as site-limited, the
    inspector should review sales records to verify that the chemical or chemicals have not  been
    distributed for commercial purposes.  However, it should be noted that reviewing the sales records
    could be difficult and time consuming depending on the size of the site. The inspector should ask
    the facility's representatives how the chemical is used and what makes that use site-limited.
                               DEFINITIONS (40 CFR §770.23)
         Site-United is defined as a chemical that is manufactured and processed onfy within a site
         and is not distributed for commercial purposes as a substance or as part of a mixture or
         article outside the site.  Imported substances are never site-limited.
TSCA 55 5/8 Inspection Guidance            7-23                              November 1992
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 TSCA Section 8 Inspections	Chapter Seven
 The inspector should note that, in general, whenever there are any discrepancies between what was
 reported and what is found during the review of records, the inspector should copy the appropriate
 records that document the discrepancy and include them as part of the inspection report (see Chapter 10).

 7.3.3  PHASE 2 INSPECTION
 The second phase of the IUR inspection verifies that all chemicals on the TSCA Section 8(b) Inventory
 that are manufactured or imported by the facility during the applicable  reporting period have been
 reported within the specified timeframe (unless the manufacturer or  importer is exempt).

 Duiiug the inspection, the inspector should compare the company's list of manufactured and/or imported
 chemicals against die TSCA Section 8(b) Inventory.  [This part of  the inspection is generally done in
 conjunction with the Section 5 General Inventory inspection (see Section 6.2.2).] A comparison of these
 two lists could result in the following two situations:
     The company manufactured or imported a chemical during the applicable reporting period that is not
     on the Inventory and the company has not submitted an IUR or included the chemical on its IUR.
     The company manufactured or imported a chemical during the applicable reporting period that is on
     the Inventory but the company has not submitted an IUR report because it is claiming an exemption
     to IUR reporting.
In the first situation the inspector generally should not find (during an inspection) a chemical on the IUR
that is not already on the TSCA Inventory because EPA Headquarters would find this discrepancy first
when the company submits its IUR report.  However, this may occur when the inspector does not have
access to the CUS database and instead uses the published TSCA Chemical Substance Inventory: 1985
Edition (January 1986) when checking the chemicals on the IUR.  In this case, the identified chemical
that is not on the published Inventory (hard copy) will be in the up-to-date CUS database that contains
confidential and public information.  The inspector will not be able to confirm that the chemical is on the
TSCA Inventory until s/he can search the database.

In the second situation, the chemical being manufactured or imported by the company is subject to IUR
reporting because it is found on the Inventory but the company is claiming an exemption. The inspector
should verify that the company meets the criteria listed in 40 CFR §710.29 and §710.30 for exemptions
as described below.
November 1992                              7-24            TSCA §§ 5/8 Inspection Guidance
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Chapter Seven	TSCA Section 8 Inspections

  • Verifying reoortahle  quantities.  The inspector should review the production records  for each
    company site to verify that at any single site the chemical was not manufactured,  imported, or
    processed in an amount of 10,000 pounds or more during the corporate year preceding the reporting
    period.  In cases where the site has produced more than 10,000 pounds and the company is not
    exempt from reporting for any other reason, the inspector should copy the pertinent records.

  • Verifying small manufacturer exemption. The inspector should review sales records to determine
    the total annual sales for the company and its parent company.  If the company official is reluctant
    to provide such data because it is privately owned, the inspector should explain to company officials
    that such information can be claimed as Confidential Business Information (CBI).  The inspector
    should also review the production records to determine the production in pounds for each chemical
    subject to IUR reporting.  If the production records for a liquid chemical are expressed in gallons
    rather than pounds, the inspector needs to multiply the specific gravity for that chemical (expressed
    in pounds per gallon) by the gallons to obtain the production in pounds.
                 SmaB Manufacturer Exemption Criteria (40 CFR §710.29)
         If the company's total sales combined with its parent company's sales exceed $40 million.
         the company must submit IUR reports for the manufacture or Importation of 10,000 pounds
         or more of each particular chemical at any individual site.

         If the company's total sales combined with  its parent company's sales are between $4
         million and $40 million, the  company  must submit IUR reports for manufacture or
         importation of 100,000 pounds or more of each particular chemical at any individual site.

         If the company's total annual sales combined with the parent's company sales are less than
         $4 million, then the company is exempt from IUR reporting as a small manufacturer or
         importer.                                 	
    If the company does not meet the small manufacturer criteria, the inspector should copy records
    documenting this finding and include them as part of the inspection report.
  • Verifying Pftp CTffWttoni  The inspector should review R&D notebooks, reports, production
    records, and sales records to ensure that the chemical was in fact produced only for R&D purposes.

  • Verifying chemical imported as part of an article.  The inspector should review documentation
    describing die imported article and how the subject chemical is incorporated into the article.  This
    documentation may be in the form of sales brochures or product descriptions.
TSCA §& 5/8 Inspection Guidance            7-2S                             November 1992
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 TSCA Section 8 Inspections                                                    Chapter Seven
                                DEFINITION (40 CFR $710.2)
         Article means a manufactured item (I) which is fanned to a specific shape or design during
         manufacture, (2) which has end use functionfs) dependent in whole or in part upon its
         shape  or design  during  end use. and  (3)  which has either  no change  of chemical
         composition during its end use or only those changes of composition  which have no
         commercial purpose separate from that of the article, and that result from a chemical
         reaction that occurs upon end use of other chemical substances, mixtures, or articles;
         except that fluids and particles are not considered articles regardless of shape  or design.
  •  Verifying manufactured or imported chemical is a polvmer. inorganic substance, microorganism or
     naturally occurring SUfrSBflCffi The inspector should review records substantiating that the chemical
     meets the criteria for inorganic chemical  substance [40 CFR  §710.26(a)];  polymer [40 CFR
     §710.26(b)];  microorganism [40 CFR §710.26(c)]; or naturally occurring substance [40 CFR
     §710.26(4)].  These types of records may include the production files, sales files, sales brochures,
     or others, depending on which criteria applies to the chemical.  The inspector should gather all
     questionable data regarding exemptions and send it through the ER process for a technical opinion.

     However, the inspector should note that not every polymer or inorganic chemical identified is listed
     on the TSCA Inventory.  The inspector should solely use the Inventory as a means to determine
     whether a substance is exempt.
7.4 SECTION 8(c):  ALLEGATIONS OF SIGNIFICANT ADVERSE HUMAN HEALTH OR
    ENVIRONMENTAL EFFECTS

Under TSCA Section 8(c), companies are required to record allegations of previously unknown significant

adverse reactions to any substance or mixture they manufacture, import, process, or distribute. EPA may

require the reporting of these allegations, on a chemical or company-specific basis, by notice in the
Federal Register or by letter to specific companies.


The Section 8(c) rule became effective on November 21,1983 (40 CFR Part 717). This Section 8(c) rule

provides a mechanism to identify previously unknown chemical hazards.  It may reveal (to EPA or an

individual recordkeeper) patterns of adverse effects that otherwise may not be noticed or detected.  The

rule describes the types of allegations to be recorded by any manufacturer or importer of a chemical

substance or mixture subject to the rule. The types of allegations mat must be documented as well as the

types of allegations that are exempt from the recordkeeping requirements are summarized in Table 7-2.

No exemptions exist for small manufacturers and processors.


Allegations that are subject to the rule implicate a chemical in an adverse reaction by:
November 1992                              7-26           TSCA ${ 5/8 Inspection Guidance
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>
•o*
«e»
01
                                    TABLE 7-2.  SECTION S(c) ALLEGATIONS THAT MUST BE RECORDED
              Required
              Not
              required
              Required
              Not
              required
 I
40CFR717.12(a)
40CFR717.12(b)
40 CFR 717.3(c)(l)
40 CFR 717.3(c)(2)
40CFR717.12(c)
40  CFR717.12(d)
Human health
                     Human health
Environmental
Environmental
                                                                                                                       *
                                                                                                                       i
                                      • Long-lasting or irreversible damage, such as cancer or birth defects
                                      • Partial or complete impairment of bodily functions, such as reproductive
                                        disorders, neurological disorders, or blood disorders
                                      • An impairment of normal activities experienced by all or most of the persons
                                        exposed at one time
                                      • An impairment of normal activities experienced each time an individual is
                                        exposed.
                    Exemption for known human health effects.  Defined as commonly recognized
                    human health effects of a particular substance or mixture as described in
                    scientific articles or publications, the firm's product labeling, or the firm's
                    material safety data sheets.  An effect is not a known human health effect if it:

                    •  Was a significantly more severe toxic effect than previously described in
                      scientific articles or publications
                    -  Was a manifestation of a toxic effect after a significantly shorter exposure
                      period or lower exposure level than described
                    -  Was a manifestation of a toxic effect by an exposure route different from that
                      described.
                                      •  Gradual or sudden changes in the composition of animal life or plant life,
                                         including fungal or microbial organisms, in an area
                                      •  Abnormal number of deaths of organisms (for example, fish kills)
                                      •  Reduction of the reproductive success or the vigor of a species.	
                                         Alleged cause of significant adverse reaction can be directly attributed to an
                                         accidental spill or other accidental discharge, emission exceeding permitted
                                         limits, or other incident of environmental contamination that has been reported
                                         to the Federal Government under any applicable authority.
8
I
Oe
                                                                                                                                                 «v
                                                                                                                                                 I
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 TSCA Section 8 Inspections	Chapter Seven

  •  Naming the specific substance
  •  Naming a mixture or article that contains a specific substance
  •  Naming a company process or operation in which a specific substance is involved
  •  Naming an effluent, emission, or other  discharge from a site of manufacturing, processing, or
     distribution of a specific substance.

 Allegations may be submitted in writing or made orally. If oral, the company may either transcribe the
 allegation, or inform the alleger mat the allegation may be subject to the Section 8(c) rule and suggest
 that the alleger submit the allegation in writing.  The company is not obligated to record the allegation
 if, after requesting, the alleger does not put the oral allegation into writing.  In addition, the company
 is not required to record reports of known adverse health effects (Table 7-2).

 No automatic reporting provision exists under Section 8(c).  The rule states mat when the reporting of
 records is required, firms will  be notified by letter, or by a notice in the Federal Register, of what
 chemical, when, and where to report.

 Records of all allegations are to be maintained as referenced in the rule (40 CFR §717.15). A summary
 of the recordkeeping requirements is presented in Table 7-3.

 The following persons are exempt from maintaining allegation files (40 CFR §717.7):

  •  Persons whose manufacturing activities consist of mining or other solely extractive functions
  •  Persons who are solely distributors.  If a distributor also repackages chemicals or mixtures, then the
    distributor is a processor and not exempt  from the rule
  •  Persons who are retailers of a chemical substance, unless such persons are also manufacturers or
    processors who are subject to the rule.

7.4.1 INSPECTION OBJECTIVES
The objectives of the inspection to determine compliance with Section 8(c) are:

  •  To check the company's awareness of the Section 8(c) rule
November 1992                              7-28            TSCA Si 5/8 Inspection Guidance
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                                       TABLE 7-3.  SECTION 8(c) RECORDKEEPING REQUIREMENTS
r
o
E.
                CltaOoa
                717.15(a)
Location
                717.15(b)
Content
                717.15(c)
Structure
                717.15(d)
Retention
Period
!
                717.15(e)
Transfer
                                         •  Records of significant adverse reactions
                                            other appropriate location central to the
                                        should be kept at the firm's headquarters or at any
                                        firm's chemical operations.
The record must contain the following:

•  Original allegation and abstract
•  Name and address of plant or
   facility
•  Date allegation received
•  Implicated substance, mixture, or
   article
•  Process, operation, or site
   discharge
                                                                                 Description of alleging party
                                                                                 Description of alleged health effects
                                                                                 Description of nature of environmental effects
                                                                                 Results of internal or company investigations of
                                                                                 allegation
                                                                                 Copies of required records or reports.
Records must be retrievable by the alleged cause of the significant adverse reaction:
                                         •  Chemical
                                         •  Mixture or article
                                         •  Company process or operation
                                         •  Site emission, effluent, or other discharge.
   Allegation records received from employees must be kept for 30 years.
   All other allegation records must be kept for 5 years.
   If a firm ceases to do business, the successor must keep all records.
   If a firm ceases to do business and no successor exists, these records must be transferred to
   EPA.
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TSCA Section 8 Inspections	Chapter Seven

  • To verify the accuracy and completeness of information contained in the allegation files

  • To identify firms with no allegations on file when adverse effects have been reported

  • To identify firms who have not submitted allegations under a Section 8(c) call-in.


1.42  INSPECTION GUIDELINES

The following guidelines should provide assistance to the inspector in assessing compliance with Section

8(c) allegation recordkeeping requirements.
    Verifying company awareness. This item applies to determining the company's general awareness
    of the Section 8(c) rule.  While not an enforceable requirement, verifying the extent of company
    awareness of Section 8(c) requirements can improve future industry compliance.  The inspector
    should review and obtain a copy of the company's policy or procedures for keeping records (i.e.,
    records setup and maintenance procedures). The inspector should review documentation (if any) of
    how the  company informs employees of the 8(c) rule.  If  no documentation exists, the inspector
    should discuss with company officials the company's general knowledge of the Section 8(c) rule and
    methods  of bow employees can be informed.

    Verifying allegation records not kept as required (see Table 7-3 for specific requirements).  This
    item applies to the location, content, and structure of the file. The company must keep records at
    corporate headquarters or other appropriate location.  If any elements'are missing, incomplete, or
    inaccurate, the inspector should copy the entire allegation file to substantiate any suspected violation.

    Verifying allegation records not reported as required by EPA.  This item applies to reporting of
    allegation records. The inspector should check the CORK list to determine whether allegations for
    a specific chemical were required to be reported to EPA [i.e., an 8(c) call-in].  If allegation records
    for the chemical are subject to an 8(c) call-in and the company has not reported its records, the
    inspector should copy the appropriate records and discuss with company officials the reason for non-
    submittal.
November 1992                              7-30            TSCA 55 5/8 Inspection Guidance
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Chapter Seven	        		TSCA Section 8 Inspections
                                            SUMMARY
         The company must keep the fallowing items in its files:

           • Original allegation

           • Abstract of the allegation along with:

             -  The name and address of the plant site that received the allegation

             -  The date the allegation was received at that site

             -  The implicated substance,  mixture, article, company process or operation, or site
                discharge

             -  A description of the alleger.  If the allegation involves a heal'th effect, the sex and
                year of birth of the individual should be recorded.

             -  A description  of the alleged health effects.  The description must relate how the
                effects became known and the route of exposure, if explained in the allegation.

             -  A description  of the nature of the alleged  environmental  effects, Identifying the
                affected plant and/or animal species, or contaminated portion.
    In addition, Section 8(c) files must be retrievable by the alleged substance, process, or emission, and
    not by any other designation, such as the alleger's name or site. If records are not accessible in this
    manner, the filing system and specific deficiencies should be documented in detail. In addition, the
    inspector should copy file folder titles.  Additional information that the inspector should obtain are
    the number of allegations that  are on file and  the chemical(s) involved.  Copies of multiple
    allegations for the same chemical or process should be obtained for review by EPA Headquarters.
    For example,  if severe headaches and shortness of breath have been reported by two or more
    employees working on the same process, copies of these  allegations should be collected.  The
    inspector should also refer to Section 8(e) submissions.  Depending on the pattern of Section 8(c)
    allegations, Section 8(e) violations may also have occurred.

    Verifying no allegations on file.  This item applies to the difficult task of establishing the existence
    of nonrecorded allegations.  First of all, if no adverse health allegations are on file,  the inspector
    must determine if any allegations were reported for which the company concluded that the allegations
    were not subject to recordkeeping requirements under 40 CFR §717.12(c) or (d).  To do this, the
    inspector should review incident and consumer complaint files,  along with spill, release,  OSHA
    200/100, safety, and general employee medical and health records. If these or other records contain
    information that suggests an allegation was not recorded, the inspector should record the name of
    the alleger; date(s) of the incidents);  symptoms and effects; the chemical, mixture, or process
    involved;  expert opinions; and the company's response.  Most importantly, the inspector should
    attempt to obtain any  copies of correspondence to the company or a written statement from the
    alleging party.
TSCA ftft 5/8 Inspection Guidance            7-31                               November 1992
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TSCA Section 8 Inspections	Chapter Seven

  •  Verifying records not retained for the required length of time. The company should retain employee
     allegations for 30 years, and all other allegations for 5 years.  The inspector should document all
     allegations on file at a company for compliance verification during future inspections.  When
     participating in a first-time inspection, the inspector should ask the company representative about the
     company's retention procedures to verify that they are aware of requirements.  Any indication that
     prior allegations have not been retained should be documented as well as possible (e.g., with a
     signed statement).  During the re-inspection of the location where Section 8(c) allegation files are
     kept, the inspector should review all previous listings or copies of allegations from previous
     inspections.   The inspector should  investigate any suspected disappearance or  alteration of
     allegations. If an employee submitted the missing or altered allegation, the inspector should attempt
     to interview the employee (or relatives or associates) to document recent medical history and other
     pertinent facts. Intentional alteration or destruction of Section 8(c) allegation files may warrant a
     criminal referral.
7.5 SECTION 8(d):  HEALTH AND SAFETY STUDIES

Generally, under TSCA Section 8(d), rules may be promulgated to require manufacturers, importers, or

processors (or prospective manufacturers, importers, and processors) to submit to the Administrator lists
and/or copies of ongoing and completed health and safety studies.  Under this authority, EPA has
promulgated a model health and safety data reporting rule (40 CFR 716).


The model Health and Safety Data Reporting Rule was developed to gamer data on chemical substances

and mixtures for which  EPA requires health and safety information in fulfilling the goals of TSCA.

Persons who must report under the rule include:
  • Current and prospective manufacturers, processors, and importers

  • Those persons who, in the 10 years preceding the effective date that a substance or mixture is added
    to 40 CFR  §716.120, either has proposed to manufacture, import, or process, or has  actually
    manufactured, imported, or processed the substance or mixture.


A list of studies  subject  to, and exempt from, the Section 8(d) rule is found in Table 7-4.  Copies of

studies in a person's possession at the time of a chemical's listing on the rule and copies of completed

studies ongoing when listed on the rule or subsequently initiated  must be submitted.   The following

categories of studies must be listed:

  • Studies ongoing at the time a substance is listed

  • Studies initiated after the date a chemical becomes subject to the rule

  • Studies that are known but not possessed, and

  • Studies previously sent to another Federal agency without confidentiality claims.
November 1992                              7-32            TSCA 98 5/8 Inspection Guidance
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                                TABLE 7-4. SECTION 8(d) REPORTING REQUIREMENTS
§
Q
-J
u>
t4ocfm>
716.10
716.20
716.30
716.35

Health*
Safety Studies
Exemptions
from
Reporting
Copies of
Studies
List of Studies
' ^ixo,' , % ',V X 1^4' 's S>, 's ' f/ ' ''''s ', ''' ''•••. , •.<•'' *
Wl^MM^M^M^^i^''\^'^^ -I vv:
*W. '"^tiffs' •* ^'5^«i T ° \ 3*4> i •>/"' '' < "f"»f r * -VT ' 'i^S'^?^K'
Health and safety studies on any substance or mixture listed in 40 CFR £716. 120 that are unpublished are
reportable. This requirement has limitations according to the nature of the material.
Studies published in scientific literature
Studies previously submitted to EPA-OPPT
Studies previously submitted to another Federal agency (must still be listed)
Studies conducted or initiated by or for another person who will report the studies
Studies of chemical substances not on the TSCA Chemical Inventory
Studies when substance or mixture is an impurity
Studies of chemical substances or mixtures previously submitted by trade associations
The following types of studies for a mixture:
- acute oral toxicity
- acute dermal toxicity
- acute inhalation toxicity
- primary eye irritation
- primary dermal irritation
- dermal sensttization
- physical and chemical properties
• Analyzed aggregations of monitoring data acquired more than S yean; before added to list
• Analyzed aggregations of monitoring data on mixtures when the data are not analyzed to determine the
exposure or concentration levels of the substances in the mixture.
Persons must send copies of any health and safety studies in their possession for listed chemicals and
mixtures (unless exempt).
« Ongoing Studies
• Initiated Studies
• Studies that are known but without possession of copies
* Studies previously sent to Federal agencies without confidentiality claims.

                                                                                                            I
                                                                                                            I
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TSCA Section 8 Inspections	Chapter Seven

The rule, however, does limit several of the requirements for submitting studies.  For example, the rule
limits the file search to studies in the company's currently active files. The firm does not have to search
files retired prior to December 31, 1979.  In addition, companies can restrict the search for information
to files in which such information is expected to be found in the ordinary course of business.

The rule requires all persons subject to the rule to submit information within 60 days after the effective
date of the placement of a chemical on the list. The rule also contains a sunset provision, which states
that the  reporting period on the listed substance will terminate no later than 10 yean  after the effective
date on which the substance is listed in 40 CFR §716.120. However, ongoing studies must be submitted
whenever they are completed. The inspector should note that no mandatory recordkeeping requirements
exist for this rule.

7.5.1 INSPECTION OBJECTIVES
The objectives of the inspection to determine compliance with Section 8(d) are:

  • To  check me company's awareness of the  8(d) rule
  • To  verify the accuracy and completeness of health and safety data reported
  • To  identify firms that have not reported health and safety studies.

7.5 J INSPECTION GUIDELINES
The following guidelines should provide assistance to the inspector in assessing compliance with Section
8(d) health and safety study reporting requirements.
    Verifying company awareness. This item applies to determining the company's general awareness
    of the Section 8(d) rule. While not a regulatory requirement, if the company does not manufacture
    or import a chemical subject to Section 8(d), ascertaining the company's awareness  can improve
    future industry compliance.  To determine the company's awareness, the inspector should discuss
    the following hems with the company officials:
    -  Whether the company has a contact person responsible for (1) keeping track of the Section 8(d)
       rule, (2) being aware of the chemicals that are added to the existing list in 40 CFR §716.120, and
       (3) knowing which of their chemicals are subject to the reporting requirements.  The inspector
       should report the name, position title, and phone number of the contact person.
November 1992                              7-34            TSCA 55 5/8 Inspection Guidance
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Chapter Seven	TSCA Section 8 Inspections

     -  Whether the company has a central file or office where a copy of the Section 8(d) rule and
       amendments are maintained. The inspector should review this file and record the dates of Federal
       Register notices or other directives, notices, or directives relative to Section 8(d).

     -  Whether the company has internal procedures for monitoring/tracking any studies to determine
       when the company must report under Section 8(d). If so, the inspector should obtain a copy for
       inclusion in the inspection report. If no copy is available, the inspector should describe in the
       inspection report any procedures that are provided verbally.

     -  Whether the company has  a testing facility on  site or at the headquarters site, or whether
       contractors are used to conduct testing.  The inspector should document the name and address of
       the testing facility if it is not located at the site being inspected.

  •  Verifying health and safety studies information as inaccurate or incomplete.  The inspector should
     review copies of Section 8(d) submissions before the inspection (if possible). The inspector should
     request the list of studies submitted to EPA. (Generally, a company submits these studies to EPA
     with a cover letter listing each study.) The inspector should review  all testing, monitoring, and risk
     assessment files for the subject chemical to verify that the list of submitted studies is complete and
     accurate. If the inspector is unsure of which files to review, s/he should discuss with the company
     official  what types of studies are of concern and ask in which company files these studies would be
     found.  The inspector should then search the identified files for the studies; however, the inspector
     should not be limited to these files if s/he believes that other files may contain health  and safety
     studies.  This type of review is very difficult and time-consuming to conduct because the type of
     information and data being reviewed is highly technical  (see Figure 7-5). If studies are found that
     appear to meet the criteria hi 40 CFR Part 716, the inspector should make copies of such studies and
     obtain a statement from the company official explaining why the studies were not submitted.

     The inspector should record the dates and tides of studies that appear to have been published in the
     scientific literature, or otherwise submitted to the EPA.  The  inspector should also check for any
     ongoing testing of Section 8(d) chemicals, including any  physical/chemical testing.  Examples of
     health and safety studies are listed in Figure 7-5.

  •  Verifying reports not submitted. During the inspection, the inspector should compare the company's
     list of manufactured and/or imported chemicals against  the latest CORK list. Any chemical listed
     on CORK as subject to Section 8(d) reporting for which no health and safety studies were submitted
     should be noted.  The inspector should then attempt to  identify if the company has any reportable
     health and safety  studies that meet the  criteria of 40 CFR Part 716 and have not been submitted.
     The inspector should note that a search for health and safety studies is very difficult and time
     consuming (h can take from 2 to 4 days).  If the inspector suspects  or has reason to believe that the
     company has not submitted the required health and safety studies,  s/he may want  to consider such
     a search in a second fbllowup inspection.
7.6 SECTION 8fe):  NOTIFICATION OF SUBSTANTIAL RISKS

The self-implementing provisions of Section 8(e) went into effect on January 1,  1977.  Section 8(e)

requires any person who manufactures, imports, processes,  or distributes in commerce a chemical

substance  or mixture  and who obtains information that reasonably supports the conclusion that such
TSCA 8S 5/8 Inspection Guidance            7-35                               November 1992
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 TSCA Section 8 Inspections                                                      Chapter Seven
                                         FIGURE 7-5

                              HEALTH AND SAFETY STUDIES

   For the purposes of 40 CFR Part 716, the Health and Safety Data Reporting Rule, a health and
   safety study means "any study of any effect of a chemical substance or mixture on health or the
   environment or on  data, including underlying  data and epidemiological studies,  studies of
   occupational exposure to a chemical substance or mixture, lexicological, clinical, and ecological
   or other studies of a  chemical substance or mixture, and any test performed under TSCA."

   Examples of studies (40 CFR §716.3) include:

     • Long-  and  short-term tests  of mutagenicity,  carcinogenicity, or teratogenicity;  data on
       behavioral  disorders; dermatoxicity;  pharmacological effects;  mammalian  absorption,
       distribution, metabolism,  and excretion; cumulative, additive, and synergistic effects;  and
       acute,  subchronic, and chronic effects

     • Ecological or other environmental effects on invertebrates, fish, or other animals and plants,
       including acute toxicfty tests, chronic toxicity tests, critical life-stage tests, behavioral tests,
       algal grown tests, seed germination tests, plant growth or damage tests, microbial  function
       tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm)  studies.

     • Assessments of human and  environmental exposure, including  workplace  exposure,  and
       impacts of a particular chemical substance or mixture on the environment, including surveys,
       tests, and studies of the following:  biological, photochemical,  and chemical degradation;
       structure/activity relationships; air,  water,  and   soil transport;  biomagnification  and
       bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure,
       evaporation rates from soil and water, octanol/water partition coefficient, and water solubility

     • Monitoring data, when they have been aggregated and analyzed to measure the exposure of
       humans or the environment.
November 1992                              7-36             TSCA 55 5/8 Inspection Guidance
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Chapter Seven	TSCA Section 8 Inspections
substance or  mixture  presents a substantial risk of injury to health or environment to report that
information to  EPA immediately,  unless EPA  already has  knowledge of the information.   Such
information need not establish conclusively that such a risk exists.  In general, the chemical industry
derives its Section 8(e) reports from two  sources:  (1) results of human, animal, and environmental
studies; and (2) incidents involving chemicals, mixtures, effluents, or processes.

While EPA was not required to publish any regulations or rules for Section 8(e), EPA did issue a Policy
Statement in the Federal Register on March 16, 1978 (43 FR 11110), which is included in Appendix 11.
This continues to serve as the primary source of guidance to companies subject to Section 8(e).  Also,
in June 1991, EPA published a Section 8(e) reporting guide, as well as numerous Section 8(e)-related
Question and Answer (Q&A) documents (See Appendix  12).  Table 7-5 summarizes  the types of
substantial risk information that must be reported.

In reviewing enforcement cases, EPA found that some companies might have been misinterpreting TSCA
Section 8(e).  EPA announced in February  1991 (56 FR 4128) the TSCA Section 8(e) Compliance Audit
Program (CAP).   The CAP was a one-time, voluntary compliance program designed to encourage
companies to audit their files  voluntarily for studies reportable under Section 8(e). CAP was developed
to encourage  industry reporting by setting guidelines that identified in advance EPA's enforcement
response and allowed companies  to assess liability  prior to electing  to  participate.   After minor
modifications in the original February 1, 1991, agreement,  EPA set the final report submission date for
February 28,  1992 (56 FR 19514).  However, EPA has granted reporting extensions on a case-by-case
basis. In reviewing existing guidance in connection with CAP, EPA determined that guidance on the
release of chemical substances to and the detection of chemical substances in environmental media needed
additional clarification to avoid potential over-reporting under CAP and to improve general compliance
with Section 8(e).  To this end,  EPA extended the reporting deadline to 6 months after the publication
of final refined reporting guidance for this type of information. (To date, no final guidance has been
released.)  (Reporting guidance is found in Appendix 12). As of the final reporting date, 123 companies
enrolled in CAP.

Persons who obtain information that appears to constitute substantial risk information, but who do not
manufacture, process,  or distribute the subject chemical are not required to report under Section 8(e).
TSCA S$ 5/8 Inspection Guidance            7-37                              November 1992
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f
                                   TABLE 7-5.  SECTION 8(e) INFORMATION THAT MUST BE REPORTED
U)
00
Ul
oo
              43 FR 11112
              43 FR 11112
              43 FR 11112
                      Human health
                      Environmental
                     Emergency1
                                                              *i£^
   Any instance of cancer, birth defects, mutagenicity, death, or serious or prolonged
   incapacitation, including the loss or inability to use a normal bodily function with a
   consequently relatively serious impairment of normal activities, if one (or a few)
   chemical(s) is strongly implicated
   Any pattern of effects or evidence that reasonably supports the conclusion that the
   chemical substance or mixture can produce cancer, mutation, birth defects, or toxic
   effects resulting in death, or serious or prolonged incapacitation.
   Widespread and previously unsuspected distribution in environmental media1
   Pronounced bioaccumulation.  Measurements and indicators of pronounced
   bioaccumulation previously unknown to the Administrator should be reported when
   coupled with potential for widespread exposure and any nontrivial adverse effect.
   Any nontrivial effect, previously unknown to the Administrator, associated with a
   chemical known to have bioaccumulated to a pronounced degree or to be widespread in
   environmental media
   Ecologically significant changes in species' interrelationships (changes in population
   behavior, growth, survival, etc., that in turn affect other species' behavior, growth, or
   survival)
   Facile transformation or degradation to a chemical  having an unacceptable risk.
Any environmental contamination by a chemical substance or mixture to which any of the
above adverse effects have been ascribed and which because of the pattern, extent, and
amount of contamination:

•  Seriously threatens humans with cancer, birth defects, mutation, death, or serious or
   prolonged incapacitation, or
•  Seriously threatens nonhuman organisms with large-scale or ecologically significant
   population destruction.
S.

I
' In 56 £E 28459, EPA suspended the applicability of Part V(b)(l) (i.e., widespread and previously unsuspected distribution in
environmental media) and Part V(c) (i.e., emergency incidents of environmental contamination) of the TSCA 8(e) Policy Statement in
determining the type of information to be submitted under Section 8(e).
                                                                                        IP
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Chapter Seven	TSCA Section 8 Inspections

Section 8(e) requires substantial risk information to be reported to EPA immediately.  EPA considers

information immediately reported for a nonemergency situation if they receive information within 15
working days. A company must report information concerning an emergency situation within 24 hours
by telephone.  Supplemental information received after the submission of a Section 8(e) notification
should also be immediately reported.


No mandatory recordkeeping requirements exist for Section 8(e) submissions.


7.6.1 INSPECTION OBJECTIVES

The objectives of the inspection to determine compliance with Section 8(e) are:


  • To check the company's awareness of Section 8(e)
  • To verify the accuracy, completeness, and timeliness of substantial risk submissions
  • To identify firms that have failed to report substantial risk information.


7.6.2 INSPECTION GUIDELINES

The following guidelines should provide assistance to the inspector in assessing compliance with Section
8(e) substantial risk information reporting requirements.


  • Verifying company awareness.  This item applies to determining the company's general awareness
    of Section 8(e).  While company awareness is not an enforceable requirement, verifying the extent
    of company awareness of Section 8(e) requirements can increase compliance with the Section 8(e)
    substantial risk  information reporting requirements.  To determine the company's awareness, the
    inspector should discuss the following with company officials:

    -  Whether  the  company maintains copies of  the  Section  8(e) requirement, the  Statement of
       Interpretation (1978),  and/or other relevant Section 8(e) guidance documents in its files.

    -  Whether the company has a contact person at the site responsible for tracking/monitoring studies
       or events to determine whether information is reportable under Section 8(e). If so, the inspector
       should record the name, position title, and phone number of that person.

    -  Whether  the  company has  internal  procedures on file outlining its  policy for recognizing
       substantial risk information and reporting under Section 8(e).  If so, the inspector should obtain
       a copy of that procedure and include  it as an  attachment to the inspection report.  If no copy is
       available, the inspector should describe in the inspection report any procedures that are provided
       verbally.
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TSCA Section 8 Inspections	Chapter Seven

    -  Whettier the company has a testing facility on site or elsewhere, or whether contract laboratories
       are used to conduct testing. The inspector should document the name and address of the testing
       facility if it is not located at the site being inspected.

  • Verifying substantial risk submission inaccurate, incomplete,  or  late.   If possible, the inspector
    should review copies of any  Section 8(e) reports and supporting  documentation submitted by the
    company before the inspection. The inspector should conduct the search for reports at the corporate
    headquarters, since most substantial risk reports are submitted from this site.  The key aspect in
    assessing compliance is to determine the date the company (or knowledgeable officials) first became
    aware of the substantial risk information.  The inspector should examine all records, correspondence,
    and data to determine if the  15- working day  (or 24-hour emergency) deadline  was met.  The
    inspector should review interim and/or preliminary reports for long-term health and environmental
    studies, as observations of harmful effects may be documented by knowledgeable persons before the
    completion of a study (and the preparation of a final report). If the inspector suspects that earlier
    harmful effects have been observed, copies of the  interim reports and other supporting evidence
    (correspondence, laboratory  notes, etc.) should be taken to determine a  late submittal.   Other
    potential sources include studies that were aborted due to deaths or poor health of study animals, or
    studies that are ongoing at the time of the inspection for which harmful effects are evident, but for
    which no  Section 8(e) report  has yet been submitted.

  • Verifying substantial risk information not reported.   This item  applies to the  difficult task of
    determining if a company railed to report substantial risk information.
                                  DEFINITION (43 FR 1211(9
         Substantial risk information means information that reasonably supports the conclusion
         that a chemical substance or mixture presents a substantial risk of injury to health or
         environment.   A substantial risk  of injury to health or the environment is a  risk of
         considerable concern because of Out seriousness of the effect and the fact or probability of
         its occurrence.   (Economic or social benefits of use, or costs of restricting use, are not to
         be considered in determining whether a risk is substantial.)
    To gather  information, the inspector should primarily  interview company officials  and review
    ongoing and completed health effects,  environmental impact, and chemical  fate studies.  The
    inspector should  also review epidemiology, monitoring, and other workplace studies.   When a
    company registered for the Section 8(e) CAP program, a reporting guide was provided to the
    company.  This reporting guide is included in Appendix  12.  Other sources of information include
    Section 8(c) allegation records, incident  records, OSHA records, health and safety data, and
    complaint records.  The inspector  should make pre-inspection arrangements  to view copies (or
    summaries) of studies known by the company mat have been conducted on chemicals manufactured
    or imported, but for which copies are not locally available.  Currently, if  the inspector  finds
    information or data that may indicate a substantial risk, the inspector should document and obtain
    copies of the supporting information and data. During inspection followup, such information and
    data will be sent to EPA Headquarters for a determination of substantial risk.
November 1992                              7-40            TSCA S8 5/8 Inspection Guidance
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Chapter Eight	TSCA Sections 12 and 13


Chapter Eight

TSCA Sections 12 and  13 Inspections
8.0 TSCA SECTIONS 12 AND 13	 8-1

8.1 INTRODUCTION 	 8-1

8.2 TSCA SECTION 12 EXPORT NOTIFICATION RULE	 8-1

    8.2.1 INSPECTION OBJECTIVES	 8-2
    8.2.2 INSPECTION GUIDELINES	 8-2

8.3 TSCA SECTION 13 IMPORT RULE  	 8-3

    8.3.1 INSPECTION OBJECTIVES	 8-5
    8.3.2 IMPORTER INSPECTION	 8-5
    8.3.3 DOCUMENTATION  OF TSCA SECTION 13 VIOLATIONS	 8-8
    8.3.4 ENTRY REVIEW BY CUSTOMS  	 8-8


                           LIST OF FIGURES

FIGURE 8-1  EXAMPLE IMPORT CERTIFICATION STATEMENTS	8-5
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TSCA Sections 12 and 13                   	                      Chapter Eight
                                   BLANK PAGE
November 1992                           8-ii           TSCA §§ 5/8 Inspection Guidance
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Chapter Eight	TSCA Sections 12 and 13
                             8.0  TSCA SECTIONS 12 AND 13

8.1 INTRODUCTION
This chapter  contains background information  and guidance to assist the  inspector in conducting
inspections of importers and exporters of chemicals subject to the Toxic Substances Control Act (TSCA).
Section 8.2 contains the requirements under TSCA  for exporters and describes how the inspector can
determine whether  exporters are complying  with those requirements.  Section  8.3  contains the
requirements for importers under TSCA, describes  the responsibilities of U.S. Customs in  reviewing
shipment, and explains procedures for the inspector to conduct investigations of shipments referred by
Customs.

8.2 TSCA SECTION 12 EXPORT  NOTIFICATION RULE
Section 12(b) of TSCA requires any person who exports, or intends to export, a chemical substance or
mixture to notify the U.S. Environmental Protection Agency (EPA) of such export to a foreign country
if any of the following actions have been taken under TSCA with respect to that chemical substance or
mixture:

     •   Data are required under TSCA Sections 4 or S(b)
     •   An order has been issued under TSCA Section 5
     •   A rule has been proposed or promulgated  under TSCA Sections S or 6
     •   An action is pending, or relief has been granted under TSCA Sections 5 or 7.
                               DEFINITION (40 CFR $707.63)
         Exporter means the person who, as the principal party of interest in the export transaction,
         has the power and responsibility for determining  and controlling the sending of the
         chemical substance or mixture to a destination out of the customs territory of the United
         States.
EPA issued a final export reporting rule on December 16,  1980 (45  FR 82844; 40 CFR Part 707).
Under this rule, an exporter must submit to EPA a written notice of the first export, per calendar year
and per country of export, for the substance or mixture.  Notice is required for the first export or intent
to export to each foreign country of import in a calendar year. The notice must be postmarked within
TSCA §§ 5/8 Inspection Guidance            8-1                               November 1992
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TSCA Sections 12 and 13	Chapter Eight
7 days of acceptance of a definite contractual obligation to export or an  equivalent intracompany
agreement to export.  Where the actual export occurs less than 7 days after the export obligation or
agreement has been executed, the notice must be submitted to EPA  no later than the same day as the
export.

After EPA has received  the first annual  notification from  the exporter, EPA  must then  notify the
importing country's government of the availability of test data on the chemical submitted to EPA under
TSCA Sections 4 or S(b),  and of any rule, order, action, or relief under TSCA Sections 5, 6,  or 7.  The
Environmental Assistance Division (HAD) of the Office of Pollution Prevention and Toxics (OPPT) is
responsible for notifying the country's government, generally by contacting that country's embassy.

8.2.1 INSPECTION OBJECTIVES
The  inspection objectives to determine compliance are:

     •   To verify that notice of export was submitted
     •   To determine that export information submitted is accurate and complete.

8.2.2 INSPECTION GUIDELINES
     •   Verifying no submission of notice to export. Verification may require reviewing records at the
         exporter's establishment.   The inspector should compare the exporter's list of the exported
         chemicals against the Chemicals on Reporting Rules (CORR) list.
     •   Verifying accuracy and completeness of information.  The inspector should obtain copies of
         all notices of export through an Office of Compliance Monitoring (OCM) Enforcement Request
         (ER) process, and verify that they contain the following information:
         - Name and address of the exporter
         - Name of the chemical substance or mixture
         - Date(s) of export or intended export
         - Country (countries) of import
         - Section of TSCA (i.e.,  4, 5, 6, or 7) under which EPA has taken action.
November 1992                               8-2            TSCA §§ 5/8 Inspection Guidance
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Chapter Eight	             	           	   TSCA Sections 12 and 13
                                 DEFINITION (45 FR 82846)
         Country of import is defined as the country where the goods are to be consumed, further
         processed, or manufactured, as known to the shipper at the time of exportation.  If the
         exporter does not know the country of ultimate destination, the shipment is credited to the
         last country to which the exporter knows that the merchandise will be shipped.
     In addition, the inspector should determine whether the notice of export was sent to EPA within
     7 days after a definite obligation to export was accepted.
8.3 TSCA SECTION 13 IMPORT RULE
TSCA Section 13 requires the U.S. Department of Treasury (Customs) to refuse entry into the customs
territory of the United States of any chemical substance or mixture offered for entry if it fails to comply
with any rule in effect under TSCA, or if it is offered for entry in violation of TSCA Sections 5 or 6,
a TSCA Section S or 6 rule/order,  or a TSCA Section 7 order.   In addition, because TSCA defines
importers as manufacturers, importers may be subject to testing requirements under TSCA Section 4
(discussed in Chapter  S), PMN requirements under TSCA Section S (discussed in Chapter  6),  and
reporting requirements under TSCA Section 8 (discussed in Chapter 7).

The U.S. Customs Service (Customs) published a rule concerning TSCA Section 13 on August 1, 1983,
in 48 FR 34734 (19 CFR §12.118).  The Customs rule sets forth general certification requirements and
detention procedures.  However,  it does not address how a chemical shipment and its import would
comply with TSCA.  EPA issued a policy statement December 13,  1983, in 48 FR SS462 (40 CFR Part
707).  It explains how EPA interprets and executes its responsibilities outlined in the Customs' Chemical
Substances Import Rule.  The main purpose of the EPA policy statement is to describe what compliance
with TSCA means.
TSCA §§ 5/8 Inspection Guidance            8-3                              November 1992
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TSCA Sections 12 and 13
                                  Chapter Eight
                               DEFINITION (40 CFR §707.20)
         TSCA  defines "manufacture" to  include importation in addition to domestic production
         and  manufacture.   Consequently,  importers  are  responsible for ensuring that chemical
         importation  complies  with  TSCA, just as domestic manufacturers are  responsible for
         ensuring that chemical manufacture complies with TSCA.

         For the purposes of TSCA Section 13, the Customs Rule also defines an importer as:

              The person primarily liable for the payment of any duties on the merchandise, or
              an authorized agent acting on his behalf. The importer may be:

              •  The consignee

              •  The importer of record

              •  The actual owner of the  merchandise, if an actual owner's declaration and
                  superseding bond has been filed

              •  The transferee of the merchandise, if the right  to withdraw merchandise  in a
                  bonded warehouse has been transferred in accordance with Subpart C of 19 CFR
                  Pan 144 (Chapter 1).
Under the  Customs rule, the importer of a chemical shipment must certify at the port of entry for

shipments entering commerce in the U.S. either that the shipment is subject to TSCA and complies with
all applicable rules and orders or that the shipment is not subject to TSCA.  An importer can accomplish

the certification and discharge her/his obligations related to the import by signing a briefly typed or

reprinted statement on an entry document, invoice, or attachment.  An example is found in  Figure 8-1.


Certification of compliance with TSCA is required for chemical substances imported in bulk or as pan

of mixtures.  Because some chemicals (e.g., pesticides) are not chemical substances subject to TSCA.

the Customs rule  requires importers to certify that such chemicals are not subject to TSCA.  The rule

does not require certification for chemical substances imported as pan of articles, unless EPA requires

reporting under a specific TSCA rule.
November 1992
8-4
TSCA §§ 5/8 Inspection Guidance
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 Chapter Eight                                                      TSCA Sections 12 and 13
                                       FIGURE 8-1
                   EXAMPLE IMPORT CERTIFICATION STATEMENTS
   Positive certification for shipments subject to TSCA:
        "I certify that all chemical substances in this shipment comply with all applicable rules
        or orders under TSCA and that I am not offering a chemical 'substance for entry in
        violation of TSCA or any applicable rule or order under TSCA."
   Negative certification for other shipments:
        "I certify that all chemicals in this shipment are not subject to TSCA."

   (40 CFR §707.20)
83.1 INSPECTION OBJECTIVES
The inspection objectives to determine compliance of importers with TSCA are:

     •   To identify the applicable TSCA Section 4, 5, or 8 requirements for the chemical(s) being
         imported.
     •   To verify that shipments of the imported chemical(s) are in compliance with the TSCA Section
         13 requirements.

8.3.2 IMPORTER INSPECTION
In inspecting an importer to determine compliance with the applicable requirements of TSCA Sections
4, 5, and 8, the inspector should follow the procedures contained in Chapters S, 6, and 7, respectively,
of this manual.  For example, in conducting the general Inventory  Section S inspection as described in
Chapter 6 of the manual, the inspector should compare the list of chemicals imported by the company
to the TSCA Inventory to determine if any of the imported chemicals are not on the Inventory.  If the
inspector finds an imported chemical not on the TSCA  Inventory, then s/he should copy the import
records for that chemical for inclusion in the inspection report.  To avoid taking the Inventory on the
inspection, the inspector could perform such a comparison after the  inspection.  If an imported chemical


TSCA §§ 5/8 Inspection Guidance            8-5                              November 1992
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TSCA Sections 12 and 13	Chapter Eight

is identified at that time as not being listed on the TSCA inventory, the inspector could then request by

mail the import records for that specific chemical.  Likewise, to determine whether one of the imported
chemicals is subject to PAIR reporting and whether the importer has submitted the PAIR form, the

inspector should follow the procedures in Chapter 7.  The inspector should note that when the Chemical

Abstract Service (CAS) Registry Number is available for the imported  chemical, s/he  can check the

following documents:


     •   Chemicals on Reporting Rules (CORR) database report

     •   Section 12(b) Export Notification report

     •   BNA 's Chemical Regulation Reporter: Index to Government Regulations, which lists for each
         chemical all proposed and final TSCA regulations.



In addition to determining compliance with TSCA Sections 4, S, and 8, the inspector should also

determine an importer's compliance with TSCA Section 13.  To do this, the inspector would review

shipping (import) records and  review  the certification provided with each shipment.  The following

guidelines should assist the EPA inspector in assessing compliance of shipments with TSCA Section  13:


     •   No certification statement present.  In this case, shipping documents bore no certification
         statement and were not clearly Federal Food, Drug, and Cosmetic Act (FFDCA) or pesticide
         products accompanied  by  the appropriate Federal  Drug Administration (FDA) or Federal
         Insecticide, Fungicide, and Rodenticide Act (FIFRA) forms. The inspector should have already
         established whether the imported chemicals in the shipment are subject to TSCA Sections 4,
         S, or 8. However, if the inspector was unable to determine their compliance status and they
         were not accompanied by the appropriate arrival forms, their intended use may  be in doubt.
         The inspector can verify that the chemical is for non-TSCA use by consulting the following
         reference materials:

         For FFDCA uses:

             Merck Index

             The Condensed Chemical Dictionary

             Physicians  Desk Reference

         -   Harmonized Tariff Schedule.
November 1992                              8-6            TSCA §§ 5/8 Inspection Guidance
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Chapter Eight	TSCA Sections 12 and 13

         For FIFRA uses:

             The Farm Chemicals Handbook

             The Condensed Chemical Dictionary

             Harmonized Tariff Schedule.

         Cases involving shipments of chemicals that bear no certification statements, that are clearly
         FFDCA or pesticide products, and that are not accompanied by FDA or FIFRA forms should
         be forwarded to the FDA or to the Regional Pesticides and Toxic Substances Branch Chief for
         further action. (As a general policy, EPA does not require negative TSCA certification for a
         shipment that is accompanied by FDA or FIFRA forms.)

         Shipments of chemicals that bear no certification and are subject to TSCA are in violation of
         Section 13.  In this case, the inspector should document the information described in Section
         8.3.3 of this chapter.

     •   Negative certification statement present.   In this case, entry documents  showed that the
         chemicals in these shipments were certified as not subject to TSCA  but  were  not clearly
         FFDCA or pesticide products accompanied  by FDA or FIFRA forms.

         The  inspector should have already established whether the chemicals  in such shipments are
         subject to TSCA. The inspector should verify that the imported chemical is for non-TSCA use
         by consulting the reference materials listed above for determining FFDCA or pesticide usage.
         FFDCA or pesticide products without accompanying forms but bearing negative certification
         statements are in compliance with  TSCA Section 13.   However,  these  cases should be
         forwarded to FDA or the Regional Pesticides and Toxics Branch Chief for possible further
         action.

         Shipments of chemicals that are not FFDCA or  pesticide products and that bear negative
         certification  statements may have received false certification under TSCA Section 13.  If the
         inspector has already established that these shipments are subject to TSCA  Sections 4, 5, or
         8 requirements, the inspector should document the information described in Section 8.3.3 of
         this chapter.

     •   Positive certification  statement  present.   The inspector should have determined whether the
         imported chemicals  are not FFDCA or  pesticide products and whether they have positive
         certification.  If the  inspector  has found a shipment bearing positive certification to be in
         violation of some applicable rule or order under TSCA, then the shipment has received "false
         certification." This is the most serious violation of the TSCA Section 13 rule.  The inspector
         should document the  information described  in Section 8.3.3 of this chapter.

         Some imported  products may be multi-use chemicals that are subject to  either  FFDCA or
         FIFRA and  TSCA.  Cases involving FFDCA  and pesticide products with positive TSCA
         certification  that are  not accompanied by the appropriate FDA or FIFRA forms should be
         referred to the FDA or the Regional Pesticides and Toxics Branch Chief for possible further
         action.
TSCA §§ 5/8 Inspection Guidance             8-7                               November 1992
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TSCA Sections 12 and 13	Chapter Eight
8.3 J DOCUMENTATION OF TSCA SECTION 13 VIOLATIONS
In documenting a TSCA Section 13 violation, the inspector should prepare a summary that includes the
following items:

     •   Importer
     •   Date of entry
     •   Entry number
     •   Customs Broker's name and address
     •   Certification status (positive, negative, or none)
     •   Forms attached (FDA or FIFRA form present)
     •   Specific chemical information name, formula, CAS Registry Number, uses
     •   Inventory status
     •   Applicable TSCA regulations.

This summary will be used in  the preparation of inspection reports (discussed in Chapter 10) and will
provide the necessary documentation for case development.

8.3.4 ENTRY REVIEW BY  CUSTOMS
Customs may check chemical imports to determine whether shipments and their import comply with the
certification requirements and  the substantive mandates of TSCA. Customs may refuse entry to any
shipment until certification is properly submitted. Customs may  also detain a shipment if reasonable
grounds exist to believe that such shipment or its import violates TSCA  regulations or orders. A violative
shipment must be brought into compliance, exported, destroyed, or voluntarily abandoned within the time
periods prescribed in  19 CFR §12.124.

Customs may check the shipments using the following procedures.
     •   No  certification statement present.  Entry documents with no  certification statements will be
         examined by the customs inspector for the presence of forms required by FFDCA or FIFRA.
         Chemicals regulated  by FFDCA or FIFRA are not subject  to TSCA, and  so they would not
         require positive certification but should be accompanied by a negative certification, unless they
         are  accompanied  by  the appropriate FDA or FIFRA forms. (As a general policy, EPA does
         not require negative certification for a shipment that is accompanied by FDA or FIFRA forms.)
         The Customs inspector may contact the EPA Regional office  concerning shipments that bear
         no TSCA certification and are not clearly destined for FFDCA or pesticide use.
November 1992                              8-8            TSCA §§ 5/8 Inspection Guidance
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Chapter Eight	TSCA Sections 12 and 13

      •   False negative certification.  Products regulated by FFDCA or FIFRA and imported solely for
         drug or pesticide use are not chemical substances subject to TSCA.  Under the Customs Rule,
         importers are required to certify that these chemicals are not subject to TSCA unless they are
         accompanied by FDA  Form 701 or EPA Form 3540-1. (As a general policy, EPA does not
         require negative certification for a shipment that is accompanied by FDA or FIFRA forms.)
         A shipment is falsely certified if it bears negative certification but is destined for non-FFDCA
         or non-FIFRA use.

         To verify that a chemical is  subject to TSCA, Customs may check the Item number on the
         Harmonized Tariff Schedule  assigned to the shipment because  it will reflect the intended use
         of the chemical  substance.   Usage  may  also be   indicated  by  the   terms  "USP,"
         "pharmaceutical," or "pesticide" on the entry documents.   The Customs inspector may contact
         the EPA Regional office concerning shipments that bear negative  certification and are not
         clearly destined for non-TSCA use.

      •   False positive certification.  Customs may consult the TSCA Inventory to determine whether
         all of the chemicals in a shipment are on the "open" Inventory. The Customs inspector may
         also compare the shipped chemicals to the list of chemicals subject to specific  final regulations
         under TSCA  Sections 5 and 6,  and chemicals subject to proposed TSCA Sections 5  and  6
         regulations (found in the CORR database and the Section 12(b) Export Notification report).
         If the chemical  is  not  on  the  open inventory,  Customs  can flag it  as a potential  false
         certification and may refer it to EPA.

      •   "Blanket" Certification.  "Blanket" certification may be authorized by the appropriate District
         Director  of Customs to cover several shipments of the same chemical made over  a 1-year
         period.  Such a certification is subject to renewal.  Importers authorized to use blanket
         certifications  must also  include a  statement on the commercial invoice or  entry document
         referring to the blanket certification. Separate blanket certifications are required for chemicals
         subject and not subject to TSCA.  Since blanket certifications  may  be either positive or
         negative, the verification processes described above should be  applied.


After Customs has completed the initial review and has determined that the shipment should be detained,

it may notify EPA that the shipment is being held for further investigation and provide EPA with the

entry documentation. If Customs does provide EPA with this information, then EPA will review this

documentation  and identify  the reasons for the detention  and the necessary actions for an importer  to

bring the shipment into compliance with TSCA.   However,  a shipment should not be detained if it  is

accompanied by a certification  and  is apparently in compliance with  TSCA.  If EPA is unable  to

determine the applicable TSCA requirements from the documentation provided, the EPA inspector should

schedule and conduct an inspection of the importer.


The  EPA inspector should note that further investigation of a shipment referred by U.S. Customs may

become  complicated because the shipment may enter the country through a port-of-entry in one EPA

Region, while  the  importer-of-record  is located in another  Region.  Since the importer-of-record  is



TSCA §5 5/8 Inspection Guidance             8-9                               November 1992
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TSCA Sections 12 and 13	Chapter Eight
responsible for certifying compliance, enforcement actions resulting from these investigations should be
initiated in the Region in which the importer-of-record is located.  Therefore, entry documents for
shipments for which the importer-of-record is located in a Region other than the Region conducting the
entry: review at Customs  should be forwarded to the Region in which the importer-of-record is located
for further investigation.  Entry review for shipments for which the importer-of-record is located in die
Region should be conducted by that Region.
November 1992                               8-10            TSCA §§ 5/8 Inspection Guidance
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Chapter Nine	TSCA Biotechnology Regulation

Chapter Nine

TSCA Biotechnology Regulation
                                                                 Page

9.0 BIOTECHNOLOGY REGULATION	 9-1

9.1 INTRODUCTION  	 9-1

9.2 BACKGROUND  	 9-1

9.3 CURRENT POLICY	 9-2

   9.3.1  MICROORGANISMS ARE CHEMICAL SUBSTANCES	9-2
   9.3.2  DEFINING "NEW MICROORGANISM" FOR TSCA SECTION 5	9-2
   9.3.3  MANDATORY PMN REPORTING  	 9-3
   9.3.4  R&D EXEMPTION  	 9-3
   9.3.5  VOLUNTARY PMN REPORTING	 9-4
   9.3.6  VOLUNTARY SNUR REPORTING	 9-4

9.4 OTHER ISSUES  	 9-4

9.5 SUMMARY  	 9-5
TSCA §§ 5/8 Inspection Guidance         9-i                       November 1992
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TSCA Biotechnology Regulation                 	                      Chapter Nine
                                   BLANK PAGE
November 1992                           9-ii           TSCA §§ 5/8 Inspection Guidance
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Chapter Nine	TSCA Biotechnology Regulation

                           9.0 BIOTECHNOLOGY REGULATION

9.1 INTRODUCTION
The  purpose of this chapter is to  provide  inspectors with basic  information about the status of
biotechnology regulation and, specifically, the current biotechnology program under the Toxic Substances
Control Act (TSCA).  EPA is currently operating its TSCA section 5 biotechnology program under a
1986 policy statement made as part of an interagency Coordinated Framework for Biotechnology (SI FR
23313, see Appendix 14). That policy statement will remain in effect until EPA promulgates final rules
to fully implement its biotechnology program.  This chapter does not provide a "how to" guide for
inspectors, but instead provides basic information about the status of TSCA biotechnology regulation.
This knowledge will allow inspectors to answer questions and provide general information, as necessary,
on the subject.

92 BACKGROUND
Biotechnology, as defined by the U.S. Senate's Office of Technology Assessment, is any technique that
uses living organisms or substances from those organisms to make or modify a product  and perform
services,  to improve plants or animals, or to  develop microorganisms for specific uses.   Such genetic
manipulation is  not a new science and is used daily to enhance the characteristics of food (e.g., hybrid
corn, selective breeding), manufactured food (e.g., bread, cheese, yogurt), waste disposal (e.g., bacterial
sewage treatment), medicine (e.g., vaccines, hormones), and pesticides (e.g., Bacillus thuringiensis).  In
addition to these more common applications, biotechnology also includes the new molecular techniques
of genetic modification, such as recombinant DNA, recombinant RNA, and cell fusion.

Federal regulation of biotechnology research and products was formalized  in 1986 with the issuance of
the Coordinated Framework for Regulation of Biotechnology. Coordinated by the White House Office
of Science and Technology Policy, this framework is a combination of agency policy statements that were
based on existing statutes and were formulated to govern the rapidly growing biotechnology industry.
The notice included policy statements by EPA, the Food and Drug Administration (FDA), the National
Institutes of Health (Nffl), the National Science Foundation (NSF), the Occupational Safety and Health
Administration (OSHA), and the U.S. Department of Agriculture (USDA).  The primary purpose of the
policy statements is to ensure the safety of the public and prevent  unreasonable risk to the  environment.
TSCA §8 5/8 Inspection Guidance            9-1                               November 1992
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TSCA Biotechnology Regulation	Chapter Nine

In its 1986 policy statement, EPA indicated that it had authority under both Federal Insecticide Fungicide
and  Rodenticide Act (FIFRA) and TSCA to regulate certain uses  of microorganisms.  The policy
statement  explained how and why certain biotechnology products would be subject to the review and
reporting requirements under FIFRA and TSCA.  Microbial pesticides are subject to FIFRA.  TSCA
coverage of biotechnology products will be discussed below.

Certain requirements  became immediately effective upon issuance of  the 1986 policy statement. Other
aspects of TSCA coverage required rulemaking. Currently, EPA's Office of Pollution Prevention and
Toxics is  developing proposed rules to address the issues from the 1986 policy statement and fully
implement its  section 5  biotechnology program.  The remainder of this chapter discusses  both the
voluntary  and mandatory portions of the 1986 policy statement, which will remain in effect until final
rules are promulgated.

9J  CURRENT POLICY
93.1  MICROORGANISMS ARE CHEMICAL SUBSTANCES
The  TSCA section 3 definition of "chemical substance"  is broad enough to cover  living  organisms,
including microorganisms.  Similar to traditional chemicals, a microorganism is subject to premanufacture
notification (PMN) reporting under TSCA section 5 when it is manufactured  for a TSCA use and for
commercial purposes. The definition of chemical substance in TSCA excludes pesticides, tobacco and
tobacco products, food, food additives, drugs, cosmetics, and substances that are used as medical devices.
Other than the exceptions described, all microorganisms produced for environmental, industrial or
consumer  uses potentially  may be regulated under TSCA.  Potential TSCA uses of microorganisms
include  bioremediation of hazardous  waste  sites,  enhanced oil  recovery,  metal  extraction and
concentration, and specialty chemical production.

9.3.2  DEFINING "NEW MICROORGANISM" FOR TSCA SECTION 5
Only a new microorganism triggers PMN reporting just as a new chemical substance does. The definition
of "new  microorganism"  in  the  1986 policy statement  became immediately effective.    "New
microorganisms" were considered to be intergeneric microorganisms  not listed on the TSCA Inventory,
with the exception of those intergeneric microorganisms in which the  transferred material is only a well-
characterized, non-coding regulatory region. Intergeneric microorganisms are formed from combinations
of genetic material from source organisms in different genera (see discussion of intergeneric at 51 FR

November 1992                              9-2             TSCA §§ 5/8 Inspection Guidance
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Chapter Nine	TSCA Biotechnology Regulation

23352).  Therefore,  under the  current program naturally occurring microorganisms  and genetically
modified microorganisms that are not considered  by EPA to be intergeneric are considered to be
automatically included on the Inventory and thus are not new.

In a 1987 letter, EPA further clarified the applicability of its intergeneric policy to products containing
mobile genetic  elements (MGEs) or parts of MGEs, such as plasmids and transposons.  The major
consideration is the source of the original isolation of the MGE.  Microorganisms will be considered
intergeneric. and thus subject to PMN reporting as new microorganisms,  if they contain an MGE isolated
from a microorganism in a genus different from the recipient genus. Microorganisms will be considered
intrageneric. and not subject to PMN reporting as new microorganisms, if the MGE is isolated from a
microorganism in the same genus as the recipient.

9 J J  MANDATORY PMN REPORTING
Similar to the traditional chemicals program, under the 1986 policy statement, PMNs must be submitted
for new microorganisms 90 days prior to commencement of manufacture, processing, or distribution of
the new microorganisms.   The 1986 policy  statement included information on  preparing  a PMN
submission for  new  microorganisms.   In addition, submitters  are encouraged to obtain from  the
Biotechnology  Program and use the guidance in the document  entitled  "Points to Consider in  the
Preparation and Submission of TSCA Premanufacture Notices (PMNs) for  Microorganisms."

9.3.4  R&D EXEMPTION
The biggest difference between the traditional chemicals and the biotechnology programs is in the way
research and development (R&D) activities are treated.  TSCA section S(h)(3) allows  EPA to exempt
from PMN reporting requirements chemical substances manufactured in small quantities solely for R&D.
Under  the traditional chemicals program, most  R&D activities  are exempt from  review as long as
researchers comply with the requirements of 40 CFR § 720.36. The small quantities definition developed
for traditional chemicals cannot be applied with the same expectations to living microorganisms, which
have the ability to multiply and spread  in the environment.   In 1986, EPA indicated  that it would
distinguish between R&D activities involving microorganisms used under contained conditions and those
released to the environment.  EPA stated its intention to develop rules which would revoke the R&D
exemption for R&D activities  involving the release of new microorganisms to the environment.
TSCA §5 5/8 Inspection Guidance             9-3                              November 1992
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TSCA Biotechnology Regulation	Chapter Nine

The 1986 policy statement indicated that microorganisms would be considered contained if they are used
in a laboratory that complies with the NIH Guidelines or are used in a contained greenhouse, fermenter,
or other  contained structure (see criteria for "contained structure" at 51 FR 23335).  R&D activities
involving new microorganisms used under contained conditions continue to  be eligible for the R&D
exemption if the requirements of 40 CFR § 720.36 were followed.

9.3.5  VOLUNTARY PMN REPORTING
A rule must be promulgated to change the R&D exemption.  Therefore,  in the interim, EPA asked
researchers intending to release new  living  microorganisms into the environment to voluntarily submit
PMNs to the Agency prior to commencing their activities.  While researchers working in contained
structures would be subject to the requirements of 40 CFR § 720.36, EPA also specifically encouraged
them prior to the time of voluntary reporting, to keep records describing the containment procedures used
in their R&D activities.

93.6  VOLUNTARY SNUR REPORTING
In 1986,  EPA indicated that it intended to  supplement its PMN requirements by requiring persons to
report prior to the introduction of pathogenic microorganisms (including microorganisms containing
genetic material from pathogens) into the environment.  EPA planned to use its TSCA section 5(a)(2)
Significant New Use Rule (SNUR) authority to implement these requirements.  In the interim, EPA asked
persons to voluntary submit SNUR notices for (1) any new, non-agricultural use involving environmental
release of engineered pathogens, and (2) any new, non-agricultural use involving environmental release
of nonengineered  pathogens on more than  10 acres of land.  These provisions included  a request for
voluntary SNUR  reporting of  R&D activities involving release of engineered pathogens  into the
environment.   While EPA does not currently plan to develop a specific SNUR for pathogens, the
voluntary SNUR provisions will remain as pan of the interim policy until a final rule is promulgated.

9.4 OTHER ISSUES
In setting forth its policy in 1986, EPA made several statements indicating how  it planned to develop
rules to fully implement its biotechnology  program.  As  EPA has gained more experience reviewing
biotech PMNs and as  general scientific knowledge  about genetically modified microorganisms has
increased, EPA has made some changes in its plans for the biotechnology program.  EPA's plans, which
are  subject to change and require notice and comment rulemaking, are briefly summarized in this section.

November 1992                               9-4             TSCA §§  5/8 Inspection Guidance
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Chapter Nine	__^	TSCA Biotechnology Regulation

As indicated in. 1986,  EPA still  plans to limit  the  R&D  exemption to contained uses of new
microorganisms. EPA has been developing an abbreviated reporting process tailored to specific R&D
activities involving release to the environment.

In 1986, EPA also indicated that it was going to explore the possibility of using the provisions of TSCA
section  5(h)(4)  to develop exemptions from PMN reporting for  certain general commercial uses of
microorganisms in  contained structures.  EPA has pursued this approach and is planning to propose a
flexible exemption  process that will be able to accommodate additional microorganisms as EPA gains
additional experience.  EPA is also exploring use of a similar flexible exemption in conjunction with its
abbreviated  R&D  reporting process for  environmental  releases to  exempt  specific categories of
microorganisms.

As noted above, EPA had intended to develop specific SNUR requirements for certain uses of pathogens.
While EPA does plan to propose a SNUR framework for microorganisms, at this time EPA does not plan
to promulgate a SNUR for pathogens. In 1986, EPA also indicated an intention to develop a TSCA
section 8(a) rule to collect general information about microorganisms that are subject to TSCA but not
subject to PMN or SNUR reporting. At this time, EPA does not plan to develop section 8(a) reporting
rules, because EPA has gained additional information regarding environmental uses of microorganisms
through its  PMN  reviews  and because of  the  general increase  in  scientific  knowledge  about
microorganisms.

9.5 SUMMARY
The regulation of commercial biotechnology research and products  is still a relatively new process under
TSCA and is currently based on fundamental uncertainties associated with the use and characteristics of
new  microorganisms.   Until EPA  gains greater  knowledge of TSCA uses of genetically modified
microorganisms in the environment, EPA believes it prudent to screen R&D environmental releases as
well  as general commercial  uses of certain genetically modified microorganisms.  The  1986 policy
statement and any subsequent regulations under TSCA, are intended to assist EPA in its effort to prevent
unreasonable risks  to human health and the environment.  For current information on biotechnology
regulation, the inspector should contact David Giamporcaro (FTS 202-260-6362) or Ellie Clark (FTS 202-
260-3402) of the Biotechnology Program in the Chemical Control  Division.
TSCA §§ 5/8 Inspection Guidance             9-5                              November 1992
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TSCA Biotechnology Regulation                                            Chapter Nine
                                  BLANK PAGE
November 1992                           9-6           TSCA §§ 5/8 Inspection Guidance
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Chapter Ten                 	          	       Post-Inspection Activities
Chapter Ten

Post-Inspection Activities
                                                                   Page

10.0   POST-INSPECTION ACTIVITIES	   10-!

10.1   INTRODUCTION  	  10-1

10.2   FOLLOWUP	  10-1

10.3   THE INSPECTION REPORT 	  10-2

      10.3.1 OBJECTIVES  	  10-3
      10.3.2 CONFIDENTIAL BUSINESS INFORMATION CONSIDERATIONS 	  10-3
      10.3.3 ELEMENTS OF THE INSPECTION REPORT 	  10-3
      10.3.4 INSPECTION SUMMARY	  10-9

10.4   WHAT TO DO WITH COMPLETED INSPECTION REPORT	  10-9



                            LIST OF FIGURES

FIGURE 10-1  INSPECTION RESULTS SECTION OF REPORT - EXAMPLE 1	  10-6
FIGURE 10-2 INSPECTION RESULTS SECTION OF REPORT - EXAMPLE 2  	  10-7
FIGURE 10-3 TIPS FOR DEVELOPING NARRATIVE LANGUAGE  	  10-10
TSCA §§ 5/8 Inspection Guidance         10-i                       November 1992
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Post-Inspection Activities        	  	Chapter Ten
                                   BLANK PAGE
November 1992                           10-ii          TSCA §§ 5/8 Inspection Guidance
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CBI PRINTOUTS

A.   TSCA Section 5 Submitter Information (December 1989 - to
     present)
     (PMNs, TMEAs, LVEAs, PEAs, and Bonafides)

     1.   Submitters should be sorted on the PLANT SITE Address
          data (manufacturing site taken from page 7) by Region
          and then by zip.

     FORMAT:

REG. CO. Tech Contact Tech Phone Plant Site Address sti^^aion i

     2.   Please break the pages by Region so that each Region
          will have the information pertaining to their Region
          only.  For example, provide Region I with only Region I
          information, Region II with only Region II information,
          and so on for Regions I through X.  One complete copy
          (all regional data) should be provided to OCM.


B.   PAIR Submitter Information (December 1989 - to present)

     1.   Pleajie sort submissions on Plant Site information,
          first by Region and then by zip code.

     FORMAT:

     Form |:        CAS f:         Chemical Name:
     Company Name:
     PLANT SITE Address:
     Technical Contact:       Tech's Phone:

     2.   Two complete printouts should be provided.  One
          complete printout for OCM and one separated printout to
          be forwarded to each Region.

     C.   IDR Submitter Information (December 1989 - to present)

     1.   Provide a printout that shows who submitted an IUR fom
          after 12/23/86.  The printout should provide what CAS
          Is and Chemical Names were reported, and the product!or
          and importation value reported per chemical.

     2.   Submissions should be sorted on PLANT SITE information
          first by Region and then by zip code.  (If there is
          more than one form per company do not try to merge th*
          data, just display the forms in sequence.
-------
                              - 2 -
     FORMAT:

     Company Name:
     PLANT SITE Address:
     Duns Number:
     UPD-Form #:
     Postmark:
     Identifying f:           Prod-Vol:                MFC/IMP:
     Chemical Name:
     Identifying #:           Prod-Vol:                MFC/IMP:
     Chemical Name:
     Etc.:

     3.   Each Region should be provided with information for
          their Region only.  .Therefore^each Region should, have
          ^-printout"of' iSteTsubmitteri^*CiCirsh&urd lave all'  r
          regional data for late submitters.
                                  •e
D.   WITHDRAWN PMNa or PMNs which were followed by-a; 5£e)/(-f)
     order Information (December 1989 - to present)

     1.   Submissions_should^be. sorted on technical contact data
          fi^t^by-R^^n^ana tlieirby zip code.  Please provide
          OCM"with' two complete printouts.

     FORMAT:

     Region:
     PMNf:          Company Name-Street Address: City: ST:  Zip:
     Received Date:      NOC Date:     = Disp. Date:    Disp.Code:
     Tech. Contact Name:                Tech's Phone:.
     Chemical Name:

E.   WITHDRAWN, DENIED, INVALID TKEAa Information  (December 1989
     - to present)

     1.   SAME AS ABOVE:

F.   WITHDRAWN, DENIED, INVALID LVEAs Information  (December 1989
     - to present)

     1.   SAME AS ABOVE:

G.   WITHDRAWN, DENIED, INVALID PEAs Information (December 1989  •
     to present)

     1.   SAME AS ABOVE:
-------
                              - 3 -


H.   CAIR Submitter Information (December 1989 - to present)

     1.   Please sort submissions on PLANT SITE information,
          first by Region and then by State.

     FORMAT:

     Received Date:                CAS f:         Chemical Name:
     Company Name:
     PLANT SITE City and State:
     Technical Contact:       Tech's Phone: (If possible)

     2.   Two complete printouts should be provided.  One
          complete printout for OCM and one separated printout to
          be forwarded to each Region.

NCBI PRINTOUTS


I.   PMN/NOC Information (NCBI and CBI Data)

     1.   Printout 1:  The information provided in this printout
          should be sorted by Region first then by PMN case
          number.  Additionally, information is required for NOG
          dates June 1, 1989 - to present.

     FORMAT:

                                             PLANT  PLANT
          End of                   Elapsed   SITE   SITE  CO
Case/   PMN Review   NOG Date   NO. of Days  State  City  Name

     2.   PRINTOUT 2:  The information provided in this printout
          should only be sorted by the PMN case number.
          Additionally, information is required for NOC dates
          June 1, 1989 - to present.

     FORMAT:
                 End of                              Elapsed
Case*          PMN Review          NOC Date       Number of Days

     3.   Please provide a total of 11 copies of PRINTOUT I2 and
          two complete copies (one copy separated Region) of
          PRINTOUT II.
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                              - 4 -
J.   TSCATS Information

     1.   Please provide eleven (11) TSCATS printouts (or DBase
          III diskettes, whichever is simplest or quickest).  If
          it is possible, sort the information by Region.  If
          this is possible, only two hardcopy documents are
          needed.  The first copy will be used by OCM and the
          second copy needs to be separated and forwarded to the
          appropriate Region.  Please provide the
          printouts/diskettes for, Date Received: June 1, 1989 or
          later.

FORMAT:

                            REGION #:

Dunn & Bradstreet Number:
CAS Number:
Chemical Name:
TSCA Section:
Title of Report/Study:
Date Received:   •?•?'*••
Submitter/Company Name:
Plant Site Address/Location:
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GUTOANCEFOK^UM^UI^fl'l
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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. 0 C. 20460
                           VAX
                                                        OFFICE Of
                                                     PESTICIDES AND TOXIC
                                                       SUBSTANCES
MEMORANDUM
SUBJECT:  Guidance for Requesting TSCA Section 5 and 8 Enforcement
          Requests (ERs)

PROM:     Maureen T.  Lydon,  Chief  n/(
          Compliance  Branch, OCM (131*342)
          Frank v. Caesar,  Chief
          Confidential  Data Branch,  OPPT (TS-793)

TO:       Regional Toxics Branch Chiefs

     During  the  FY 1991 TSCA  Section 5 .and 8  Conference held on,
June 4-6 , 1991 , there were concerns expressed by the- Regions about;
inefficiencies  associated   with  the  Enforcement  Request  (ER)
process.. . As you know, an action plan for streamlining the process
tor handling TSCA Section 5 and 8 ERs has been finalized.  The goal
is to transfer responsibility for receiving and tracking Section 5
and 8 ERs -to_IlfD/OPPT by Nay 1,  1992.  The transition date has been
delayed   somewhat   due    to   organizational    responsibility
considerations within OPPT.

     In the action  plan,  OCM  committed to  developing/enhancing
guidance to  the  regions on requesting  information.   Attached you
will find guidance which may be valuable  in assisting  you when
requesting certified statements from IMD.  It is important to keep
these  guidelines  in mind  when making  a  request  in order  to
facilitate a prompt response.

     If  you have any  questions  about  this  memorandum or  the
attached guidance, please feel  free to contact either of us or Ann
Clavin of OCM's Compliance  Branch at FTS-260-9438.  Thank you for
your attention to this  guidance document.

Attachment

cc:  Michael Stahl
     Mark Greenwood
     Michael wood
     Jerry Stubbs
     Michael walker
     Joe Carra
     Regional TSCA Section  568 Coordinators
     Regional Toxics  Section Chiefs
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         GUIDANCE FOR SUBMITTING TSCA ENFORCEMENT REQUESTS


 TSCA Inventory Searches/Certifled Statements

      o  Confirm that the substance in question is used for a TSCA
 regulated purpose. (FDA and FIFRA chemicals  and  uses will not be
 reflected in  the  TSCA Inventory).   If the "use  is questionable,
 submit information on the use with the request for the search or
 certified statement.

      o  Do-not accept a company's assertion that what they may be
 making  rs excluded  from  TSCA  reporting requirements  under  a
 specific exemption.  .If such an  assertion -is made,  require>.the
 company to provide a* detailed  description- of the manufacturing
 process used to produce the substance so that  it can be reviewed at
 headquarters.

      o  When requesting  a search or a certified statement, be sure
 to first check the public inventory.  This  information is available*
 in the  five. volume January  1985 Edition of the  "TSCA  Chemical!
 Substance Inventory" .and June  1990 supplement or the EPA regulated"
 Chemicals System database (which should be on-line by mid-April).

      o   Be  sure to  secure a chemical name,  Chemical Abstracts
 Service Registry Number (CASRN),  and/or chemical structure whenever
 possible.   If  possible, have  a  company representative transcribe
 the information him/herself; this makes them accountable for all
 transcriptions. DO NOT submit CASRN's that clearly identify items
 that are NOT searchable against the TSCA Inventory Master File such
 as hydrates, Colour Index Names, tradenaaes,  etc.

      o  If you are provided with a CASRN only,  have the company
(representative associate it with a chemical  name or structure in
 case the CASRM-£e invalid.'  This  way, .the name and/or structure can
 be searched.   Inspectors who have access to the chemical substance
 search service, CAS on-line,  should determine if a CASRN is valid
 and matches  the chemical  name.   All invalid  CASRN's  will  be
 returned.   Check  with  your  library or  a university  library to
 determine if they have CAS on-line.

      o  Determine if  the company can identify the manner in which
 they believe  the substance became included in the TSCA Inventory
 (i.e.  PMN,  Initial Inventory Report Font Submission such as A, B,
 C,  or  E).   If the company  is  not sure, see if  a competitor's
 product name  or  designation  (for the  "same" substance)  can be
 obtained for purposes of comparison by headquarters personnel)
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                                -2-


      o   If  the company  obtains  the substance  in question  from
someone  else in the  U.S.,  secure  the  name of  the other company.

      o   A search should  suffice  if  the substance  has  not  been
manufactured or imported for commercial purposes.  If the  substance
has  been  manufactured or imported  for commercial  purposes,  a
certified statement  will be necessary (see Attachment 1:   Form for
Requesting Inventory Searches ) .

      o   Be sMre to provide a copy of  a generic Certified
Statement with  your  request (see Attachment 2 for  an example)

PMM and  P     e
     o   Be  sure to include in your request a copy of the generic
Certified Statement which addresses your needs (see Attachments 3,
4', 5, 6  and 7).

     o  .  Provide  as  much  information as  possible  (i.e.,  case
Numbers/  DCNs,  dates of submission,  company names,  -and .chemical
identity) .  Although non-CBf requests  are preferable,  you must make
sure that enough -information  has been provided  to  complete the
certified statement.


Section  a fPATR. CAIB.  THE,  afce.l

     o   Be  as specific  as  possible concerning company name,  dates
of submission,  DCNs and chemical  identities.

     o   Provide  a copy  of a  generic certified statement  (see
Attachments 8,  9 and 10)


Technical Aflai.atanee/Qpi.ni.on

     o  Be as specific as possible concerning the request.  Include
the  reason*,  determination  to be  made  and  the timeframe for
providing the information.

     o    Provide  ZND   with as  much  background  information as
possible.
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                               -3-

Comparny Snaeifie - Pre-inspect ion information

     o  Determine the exact documents,  including the  timeframe you
want covered, about which you are concerned.   For instance,  if you
are  interested  in  all submissions made  by a particular company,
list each type (i.e., PMN,  PMN exemption  applications,  Bona  fides,
lURs, etc.).

     o  Determine  if you need actual  copies of documents or if a
listing will be adequate.

     To  the extent  possible,  try to anticipate  tne need for
certified statements and request them  in advance so  that they are
not sent  in  at  the last minute.  Also,  do not request certified
statements unless they are necessary.

General - Administrative

     o   Requests for  certified  statements  or  document requests
addressing TSCA Sections 4, 6 or 12 should continue  to be sent to*
OCM.   If there  is  a  CBZ  document  (i.e.  possibly  TSCA  Section
12(b)), OCM will request the appropriate  information  from IMD/CDB

     o  REMINDER -  Multiple requests within a single  request (i.e.
a  document  search  and  a  certified  statement)   lengthen  the
turnaround time  for the request.   If you  have  that situation,
please separate the  requests  into  two or more different requests
and identify which one needs to be completed first.
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             S8A*CH OP COMPlfTI TSCA INVENTORY
SPf ClAL NOTf PON OVIS: M • nttttnim. you mutt *•«• • vtM
cntrmeai nan* (net iradt ««•) wdw «fwmiui «iueu«.
                                         COMPANY HAM
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                       CERTIFIED STATEMENT

     I,  Linda A.  Travers,  am  the  Director of  the Information
Management  Division in  the Office  of Pollution  Prevention and
Toxics.   The Information Management  Division  is responsible for
maintaining and updating the list of chemical substances compiled
under Section 8(b)  of the Toxic Substances Control Act (TSCA) known
as  the TSCA  Chemical  Substance Inventory  (TSCA Inventory).   I
certify  that the  substance identified  below  has  completed the
Agency's PMN review process and  was included in the TSCA Inventory
as of the data specified  (or was not included in the TSCA Inventory
as of.  the date  of  signature).   I  also certify that the chemical
substance was not subject to TSCA Section 5(e) or 5(f).

PMN Case Number:

PMN Submitter:

CAS Registry Number:

Specific Chemical Name:

Date PMN Received for Agency Review:

Date PMN Review Period Expired:

Date Notice of Commencement of Manufacture
for PMN Substance Submitted to Agency:

Date Notice of Commencement of Manufacture
for PMN Substance Received by Agency:

Date PMN Substance Included in TSCA Inventory:
                                   Linda A. Travers, Director
                                   Information Management Division
                                   Date
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                       CERTIFIED STATEMENT
     I,  Linda A.  Travers,  am the  Director  of- the Information
Management  Division.   The Information Management Division of the
Cffica of Pollution  Prevention and Toxics is responsible for the
inclusion of chemical substances on the list compiled and published
under Sectioa 3(b) of the Toxic Substances Control Act.  I certify
that  the chemical substance identified below was submitted for
review,  reviewed, and  included  on the list compiled under Section
(8) as of the date specified under the terms specified in the 5(e)
Consent  Order.
SUBMITTER:
PMN NUMBER:
CAS REGISTRY NUMBER:
CHEMICAL NAME:
DATE PMN DECEIVED FOR AGENCY REVIEW:
EFFECTIVE DATE OF 5(e) CONSENT  ORDER:
DATE PMN REVIEW PERIOD EXPIRED:
DATE NOTICE OF COMMENCEMENT  SUBMITTED:
DATE NOTICE OF COMMENCEMENT  RECEIVED:
DATE CHEMICAL SUBSTANCE INCLUDED ON THE INVENTORY:
                                   Linda A. Travers, Director
                                   Information Management Division
                                   Date
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                       CERTIFIED STATEMENT

     I,  Linda A.  Travers,  an  the  Director  of  the Information
Management  Pivision in  the Office  of Pollution  Prevention and
Toxics.   The Information Management Divsion  is  responsible' for
Maintaining, and updating the  list  of chemical substances compiled
under Section 8(b)  of the Toxic Substances Control  Act (TSCA) known
as  the TSCA  Chemical  Substance • Inventory  (TSCA   Inventory).   I
certify that the substance identified below  has not been submitted
to the Agency for Premanufacture Notification  (PMN) review and not
included in the TSCA Inventory as of the date specified.

CAS Registry Number:

Specific Chemical Name:
                              Linda A. Travers, Director
                              Information Management Division
                              Date
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                            PTKD SfA
     I,  Linda  A.  Travers,  am the  Director of  the Information
Management  Division  in  the Office  of Pollution  Prevention and
Toxics (CPPT).  The Information Management Division is responsible
for  maintaining  and updating  the  list  of  chemical  substances
compiled under the Toxic Substances Control Act (TSCA) known as the
TSCA Chemical Substance Inventory (TSCA Inventory).  I certify that
the  substance  identified  below has  completed the  Agency's Low
volume  Exemption  Application  (LVEA)  review 'process  and  been
included in the confidential LVEA File of  the TSCA Inventory  as of
the date specified.
LVEA Case Number:

LVEA Submitter:

CAS Registry Number:

Specific Chemical Name:

Date LVEA Received for Agency Review:

Date LVEA Review Period Expired:

Date LVEA Substance Included in LVEA
 File of TSCA Inventory*-
                                   Linda A. Travers, Director
                                   Information Management Divisior
                                   Date
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                       CERTIFIED STATEMENT

     I,  Linda A.  Travers, am  the  director  of  the Information
Management Division.  The  Information Management Diyision of the
Office  of Pollution  Prevention  and Toxics  is  responsibla for
maintaining, and updating the  list of chemical substances compiled
under the Toxics  Substances Control  Act (TSCA)  known as the TSCA
Chemical Substance Inventory (TSCA Inventory).   I  certify that the
substance  identified  below  has  completed  the  Agency's  Test
Marketing Exemption Application (TMEA) review process and has been
included in the confidential/non-confidential TMEA file of the TSCA
Inventory as of the date specified.

TMEA Case Number:

TMEA Submitter:

CAS Registry Number
Specified Chemical Name:

Date TMEA Received for Agency Review:

Date TMEA Review Period Expired:

Date TMEA Substance Included
in LVEA File of TSCA Inventory:
                                   Linda A. Travers, Director
                                   Information Management Division
                                   Date
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                       CERTIFIED STATEMENT

     I,  Linda A.  Travers,  am  the  Director  of  the  Information
Management  Division in  the Office  of Pollution  Prevention  and
Toxics.   The Information Management Division  is responsible for
maintaining, and updating the list  of chemical substances compiled
under Section 8(b) of the Toxic Substances Control Act (TSCA) known
as  the TSCA  Chemical  Substance Inventory  (TSCA Inventory).   I
certify  that the  substance identified  below  has  completed  the
Agency's Polymer Exemption Application  (PEA) review process and has
been included in the confidential/non-confidential TSCA Inventory
as of the date specified.

PEA Case Number:

PEA Submitter:

Specified Chemical Name:

Date PEA Received for Agency Review:

Date PEA Review Period Expired:

Date Notice of Commencement
of Manufactur/Import for PEA
Substance Submitted to Agency:

Date Notice of Commencement of
of Manufacuter/Import for PEA
Substance Submitted to Agency:

Date PEA Substance Included
in TSCA Inventory:
                                   Linda A. Travers, Director
                                   Information Management Divsion
                                   Date
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                       CERTIFIED STATEMENT
         Partial Updating of the Inventory Data Base Rule
                        Search and Status
     I,  Linda  A.  Travers,  an  the  Director of  the Information
Management Division.   The Information•Management Division of the
Office  of Pollution  Prevention .and Toxics is' responsible' for
receiving, maintaining,  and managing 'information submitted under
the Partial Updating  of  the Inventory Data Base- Rule (40 CFR 710
Subpart B), Inventory Update Rule,  published under Section 8(a) of
the Toxic Substances Control Act.
     I certify that the information set out  below is complete and
accurate.
Submitter Name:
DUNS Number:
[ ] Did Submit
[ ] Did Not Submit
an Inventory Update Report
Chemical Name:
CAS Registry No.
(or Identification No.):
Postmark Date:
Date Form U Received:
Further, this substance is not encompassed by the Inventory Update
Rule's reporting exclusions  (40 CFR Part 710.26)
                              Linda A. Travers,  Director
                              Information Management Division
                              Date
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                       CERTIFIED STATEMENT
     I,  Linda A.  Travers,  am the  Director of  the Information
Management  Division.   The Information Division  of  the Office of
Pollution Prevention and Toxics is responsible for the compilation
of data from reports submitted pursuant to 40 CFR 7122, Subpart B,
Manufacturers Reporting—Preliminary Assessment  Information.
     I certify that the followiiig PAIR information was submitted:
SUBMITTER:
CAS NUMBER:
CHEMICAL NAME:
DATE PAIR SUBMITTED:
DATE PAIR RECEIVED:
                              Linda A. Travers, Director
                              Information Management Division
                              Date
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                       CERTIFIED STATEMENT
     I,  Linda A.  Travers, am  the  Director of  the  Information
Management Division.   The Information Management Division of the
Office of Pollution  Prevention  and Toxics is responsible for the
compilation  of  data  from reports  submitted pursuant to  40 CFR
704.2, Subpart C--CAIR: Comprehensive Assessment Information Rule-
General Reporting and  Recordkeeping Provisions.
     I certify that the following CAIR information, was submitted:
SUBMITTER:
CAS NUMBER:
CHEMICAL NAME:
DATE* CAIR SUBMITTED:
DATE CAIR RECEIVED:
                                   Linda A. Travers, Director
                                   Information Management Division
                                   Date
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TSCA GUimiNES. STRATEGIES AND ENFORCEMENT RESPONSE  POLICIES
DOCUMENT
DATE ISSUED
                GENERAL TSCA PENALTY GUIDANCE

Consolidated Rules of Practice Governing              04/09/80
the Administrative Assessment of Civil
Penalties and the Revocation or Suspension
of Permits [45 PR 24360]

Guidelines for Assessment of Civil  Penalties         09/10/80
under Section 16 of the Toxic Substances
Control Act; PCB Penalty Policy
[45 FR 59770]

Memorandum: Routine Use of SEC '10-K'  Statements In  10/17/80
TSCA and FIFRA Civil Penalty Actions

TSCA Settlement with Conditions                      11/16/83

TSCA Compliance/Enforcement Strategy                 11/22/83

Memorandum: Settlement With Conditions (SWC)         12/20/85
                   TSCA TECHNICAL GUIDANCE
General
Neutral Administrative Inspection Schemes
for TSCA Enforcement

Use of TSCA Section ll(c) Subpoenas
  11/07/79


  12/04/79
TSCA S4

Strategy for the Enforcement of the Good
Laboratory Practice Regulations under TSCA
and FIFRA

TSCA Good Laboratory Practice Enforcement
Response Policy

TSCA §4 Test Rule's Enforcement Response Policy
  01/15/85



  04/09/85


  05/23/86
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                              -2-
 TSCA S5; ^manufacture Notices

 Enforcement'Facts and Strategy: Premanufacture             08/80
 Notification (PMN) (ERP portion Is Obsolete).

 Compliance Strategy for TSCA S5(h)(4)  Premanufacture    11/15/83
 Notice Exemption for Chemicals Used In or for  Instant
 Photographic or Peel-Apart Film Articles

 TSCA §5 Enforcement Response Policy                     08/05/88


 TSCA S6; Asbestos

 Memorandum from A. E. Conroy to Regions: Asbestos        11/25/86
 In Schools Rule

   Transmits Two Legal Opinions from the Office of
   General  Counsel  Re:
   1) Enforcement under Title I of TSCA after
      Title II was  In Effect, and
   2) Enforcement of the Title I Asbestos 1n Schools
      Rule  for schools which opened or  commenced
      operation after June 28, 1983

 Worker Protection

 TSCA 56 Interim Strategy and Enforcement Response        07/09/85
 Policy for th'e Asbestos Worker Protection Rule
 (Strategy  replaced 09/09/86)

 OSHA Interpretations for the Asbestos  Abatement         10/03/85
 Projects Rule

 Asbestos Abatement Projects Rule Compliance             09/09/86
 Monitoring Strategy (modifies Strategy for Asbestos
 Worker Protection Rale of 07/09/85)

 Asbestos Abatement Projects; Worker Protection;         02/25/87
 Final  RtUFlSZ FR 5618]

 Final  Compliance Monitoring Strategy for the Asbestos    11/14/83
 Abatement  Projects; Worker Protection  Final Rule


 AHERA; Asbestos

Enforcement Policy for the Transition from AIS to AHERA   01/29/38

Amendment to the Enforcement Policy for the Transition     09/02/83
from AIS to AHERA
                                                              0 5 '' C 1
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                                -3-
  Memoranduau Integration of Agency Asbestos  Activities     09/29/88
  (Can be foaad In the appendix to the Compliance
  Monitoring Strategy for AHERA

  Compliance Monitoring Strategy for AHERA                 10/05/38

  Interim Final  Enforcement Policy for the Asbestos Hazard
  Emergency Response Act                                   01/31/89

  AHERA May 9th  Deferral  Deadline                           05/09/89
  TSCA S6; Chlorofluorocarbons

  Enforcement Facts and Strategy:
  Chlorofluorocarbons
11/15/73
  TSCA §6:  Polychlorlnated Blphenyls  (PCBs)

/.Guidelines for VsYessment of Civil  Penalltles             09/10/80
VUnder Sectlonxffi of the Toxic Substances
  Control  Aptrf PCS Penalty Policy  [45 FR  59770]
  (Document found under "TSCA Penalty Guidance"  Section)

  Memorandum:  Civil  Penalty Cases  Involving Use  of          09/14/81
  PCBs In  Hydraulic Systems

  Compliance Monitoring Strategy for  TSCA S6(e)  - PCBs      05/23/85

  Amendment to the Compliance Monitoring  Strategy           06/13/86
  for TSCA  S6(e) Polychlorlnated Blphenyls  (PCBs)

  Final  Second Compliance Monitoring  Amendment for TSCA     05/02/88
  Section  6(e) Polychlorlnated Blphenyls  and  TSCA Section
  6  PCB  Enforcement Response Policy Clarification
  TSCA  S$8.  12.  and 13;  Reporting Requirements

  Inventory  Enforcement  Strategy

  Compliance Strategy for Preliminary  Assessment
  Information Reporting  Rule (Level  A)

  Asbestos Reporting Rule Compliance Strategy

  Compliance Strategy for TSCA $8{d)

  Compliance Monitoring  Strategy  for TSCA §8(c)  Rule
04/25/79

07/22/82



08/30/82

12/12/82

05/18/8i
                                                               05/C
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                           - 4 -
 TSCA SI 3
Fiance Monitoring Strategy
Eva1uat1or«f the Pilot Program for Monitoring
Compliance with $13

Recordkeeplng and Reporting Rules for TSCA $58,
12. and 13; Final Enforcement Response Policy

Final Compliance Strategy for the TSCA S8(a)
Inventor> Update Rule

TSCA $58, 12. and 13 Enforcement Policy Clarification
07/12/84

01/18/85


05/15/87


06/09/87


07/13/87
                TSCA STATE RELATED  GUIDANCE
Memorandum: Maryland's Application for a TSCA Pilot       06/18/81
Cooperative Enforcement Agreement:  Issues of Preemption

Memorandum: Supplemental Guidance Procedures for State    06/19/86
Inspectors Acting Under the Authority  of TSCA $11

Memorandum: Preemption Provisions Under the;              04/05/85
Toxic Substances Control Act (TSCA)

Final TSCA Cooperative Agreement Guidance for FY89       03/10/88

Guidance for the FY89 State/EPA Enforcement Agreement     06/20/88
Process
         TSCA COMPLIANCE PROGRAM POLICY COMPENDIUM
6-AS8-1:  When to Hear Protective Clothing and
Equipment for Asbestos Regulations Compliance
6-ASB-2: wpruent of Catholic Dioceses as Local
Educat1oft*BBmc1os
          ~H*"
6-ASB-3: Qualification for Exemption from the
Asbestos In Schools Rule Based on the Asbestos
Abatement Programs

6-ASB-4: Asbestos. In Schools: "For Profit Schools"

6-ASB-5: Enforcement Response for Small Local
Education Agencies Without Friable Materials

6-ASB-6: Recordkeeplng Requirements for Schools
with Friable Asbestos Containing U*ter1als
                                            07/15/83



                                            07/02/84


                                            07/02/84




                                            05/21/85

                                            09/10/85



                                            09/10/85
                                                              05/01/39
-------
                             -5.
6-UPR-l:
Abatement^
Ir Protection Requirement  During  Asbestos
ects Using Glove Bag Procedures
6-CFC-l  Pfidact Labeling for Both Essential  and
Non-Essent1al CFC Aerosol Propellent Uses

6-PCB-l: Responsibility for Compliance with
PCS
5-PCB-2: Distillation. Solvent Extraction,
Filtration, and Other Physical Separation
Methods for PCBs

6-PCB-3: Residual PCBs In Processed Liquids
and Solids

6-PCB-4: Disposal Methods for PCBs 1n Sludge

6-PCB-6: Allocation of Enforcement Liability for
violations of the One-Year Disposal Deadline for
PCB Articles or PCB Containers

6-PCB-7: Reference Date for violations of the
One-Year Storage for Disposal Deadline for PCB
Haste Resulting from Physical Separation

6-PCB-10  First In/First Out Standard for Meeting
the PCB One-Year-Storage-for-Olsposal Requirement
04/01/88


08/30/82


03/04/82


08/16/83



08/16/83


08/13/85

08/16/83



08/16/83



08/13/85
ADDITIONAL SOURCES OF TSCA COMPLIANCE ENFORCEMENT INFORMATION

General Enforcement Policy Compendium

See page 4 of this listing for Table of Contents
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                             -6-
                 TSCA  MISCELLANEOUS SOURCES
                  art not in tne TSCA compendium but may be
                 obtained from Headquarters.)


State and Local Assistance [47 FR 44946]                 10/12/82
(40 CFR Part 35)

EPA Policy on Performance-Based Assistance               05/31/85

OECM Memorandum:  Issuance of Enforcement                08/15/85
Considerations for Drafting and Reviewing
Regulations and Guidelines for Developing
New or Revised Compliance and Enforcement
Strategies

OECM Memorandum: Policy on Publicizing                   11/21/85
Enforcement Activities

TSCA $4 Data Self Auditing Program Events                11/22/85

Final Policy Statement on Environmental                   06/13/86
Auditing

Uniform Administrative Requirements, for Grants           03/11/88,^
and Cooperative Agreements with State and         (Effective  10/01788)
Local Governments [53 FR 8075] (40 CFR Part 31)


MANUALS

Multi-Media Compliance Audit Inspection Procedures

TSCA Compliance/Enforcement Guidance Manual

TSCA Compliance/Enforcement Guidance Manual-PolIcy Compendium
                                                          05/01/89
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       -7-


OBSOLETE DOCUMENTS
EnforceaeffTTlCts and Strategy: Polychl orlnated
Blphenyls (PCBs)

Inventory Penalty Policy

PCB Enforcement Policy Subsequent to Appellate
Court Opinion Remanding Portions of the  PCB
Regulation

Guidance for Pilot TSCA Cooperative Enforcement
Agraeaasnts

New Requirements for PCB Transformers Persuant
to Appellate Court Order

Enforcement Facts and Strategy: PCB Interim
Measures Program

D1ox1n Contaminated Haste Compliance Strategy

Compliance Strategy for the Submission of Notices
of Manufacture or Importation of Polybromlnated
Blphenyls (PBB) and Trls

Compliance Strategy for the Friable Asbestos-
Containing Materials In Sc'.ools: Identification
and Notification Regulation

Model  Asbestos In Schools; Cooperative
Conp*nance Program

Compliance Assistance Guidelines for the
Asbestos-In-Schools Rule

Compliance Assistance Guidelines: Friable Asbestos
centalnlmfuiijtccfalt 1n Schools; Identification and
NotlflcttKiAmlV

Dloxln CwilHttMted Maste Enforcement Response
Policy

Enforcement Response Policy for the Friable
Asbestos Containing Materials 1n Schools
Identification and Notification Rule

General  Regulation for Assistance Programs
[48 FR 45056] (40 CFR Part 30)

Revised Asbestos-1n-Schoo1s Enforcement Response
Policy (see 10/18/85 amendment)
                                    02/80



                                 06/23/80


                                 11/11/80




                                 12/31/80



                                 03/09/81



                                    08/81



                                    01/8Z

                                 03/30/82




                                 06/24/82




                                 09/21/82



                                 12/15/82
                                  07/06/83



                                  07/06/83




                                  09/30/83



                                  07/02/84
                                     05/01/35
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                             -8-

                 M$OLETE DOCUMENTS (Page 2)
TSCA SS8,*|Dmf antf 13 Recordkeeplng and Reporting        07/30/84
Rules Enforcement Response Policy (Replaces the
Hay 23. 1980 Inventory Penalty Policy)

TSCA S5 Enforcement Response Policy Supplement          01/09/85

Amendment to the Revised Asbestos-ln-Schools            10/18/85
Enforcement Response Policy

Memorandum to Regions; Reductions and Remittances       04/1S/8S
of Penalties for Violations of the TSCA Asbestos-
ln-Schools Rule

Interim Final Amendments to the Enforcement Response    05/28/86
Policy for TSCA 513 and Interim Final Amendments
to the Enforcement Response Policy for TSCA S8(a)
Violations Involving Falsification

Interim Compliance Monitoring Strategy for the          05/30/86
Asbestos Abatement Projects Rule

Final  TSCA Cooperative Agreement Guidance for FY86/87'      02/86

Final  TSCA Cooperative Agreement Guidance for FY88      03/12/87

Memorandum:  Clarification of Section 5 Penalty          04/02/87
Policy on Notice of Commencement Violations

Interim Final Enforcement Policy for Violations of the  01/29/88
Immediately Enforceable Provisions of AHERA
                                                            05/01/89
-------
APPENDIX*
-------
                                INDUSTRIAL REFERENCES
Bikales, N.M. (ed).  1964-1972.  Encyclopedia of Polymer Science and Technology - Plastics. Resins.
       Rubber Fibers.  Interscience, New York, NY.  Supplemental volumes issued.

       Sixteen volumes that five processes, processing techniques, theoretical aspects, and the properties
       for all polymers.
Groggins, P.H.  1958. Unit Processes in Organic Synthesis. Edition 5.  McGraw-Hill, New York, NY.

       A presentation of the processes and processing conditions for making organic chemicals.


Shreve, N.R.  1967.  Chemical Process Industries, Edition 3.  McGraw-Hill, New York, NY.

       A presentation of the processes and processing conditions for producing most major chemicals.


Sittig,  M.  1966.  Organic Chemical Process Encyclopedia.  Noyes Development Corporation,  Park.
       Ridge, NJ.

       587 process flow sheets.


Standen, A.  1963-1972. Kirk-Othmer Encyclopedia of Chemical Technology, Edition 2. Interscience,
       New York, NY. Supplemental volumes issued.

       Twenty-two volumes that give all aspects of chemical'technology, including a  comprehensive
       discussion of chemical processes and processing conditions and a listing or properties for all
       mass-produced chemicals.
-------
               APPENDED



rittKEira^
-------
 Appendix  2
 Recommended Procedures for Enforcement Personnel Responsible for Handling
              Section S Confidential Business Information
IMTKOUUCTIOR
  great dial of Information on new chemicals 1s considered sensitive  by  the
chemical Industry.  Consequently, much of the Information submitted to the
agency under the Section S program — Including Information in preniariufocure
notices and test marketing exemption applications — 1s claimed TSCA  Confidential
Business Information (CBI).  Because of the large volume of TSCA CBI  wnicn Mill
be transferred and handled while conducting the Section S enforcement program,
special procedures have been developed to supplement the procedures In tne EPA
TSCA CBI Security Manual and the TSCA Base Inspection Manual.   These  procedures
should be followed by Document Control Officers (DCOs), Inspectors, and  all
other EPA personnel who receive and/or review Section S Information.

BACKGROUND                                                                 JT

Unlike other TSCA Inspection programs (particularly PCBs), the Information
used to target Section S Inspections and the Information that  1s obtained
during the Inspection will most likely be CBI.  Section S premanufacture
notification (PMN) forms and test marketing exemption (THE) requests  are
submitted to the Chemical Control Division In the Office of Pesticides  and
Toxic Substances (OPTS).  PTSED reviews this Information and prepares a  series
of Section 5 target Inspection packages to be sent to the regions.  Any  TSCA
CBI related to these packages will be sent by the DCO 1n PTSED directly  to tie
OCO 1n each region.  Under separate cover, a non-CBI memorandum will  notify
the person responsible for TSCA Inspections 1n each region that a PMN/THE
Inspection package was sent to the OCO.

Initial coordination among the OCO, the Inspectors and other reviewers  of
Section 5 CBI documents 1n the region 1sVmajor part of the Inspection
program.  The OCO and the regional Inspection coordinators should prepare
an outline describing how the entire program will work. Including organization
of a uniform Section S CBI file system that will be effectively used  throughout
the program.

The remainder of this document outlines specific procedures that regional
personnel handling CBI must follow prior, during, and following an insoec:-c^.
Some of the procedures outlined in this package repeat the TSCA Confidential
Business Information Security Manual and the TSCA Inspection Base Manual.
However, these supplemental procedures stress the Importance of effective
coordination, communication and secure handling of sensitive Information
received and reviewed under the Section 5 Inspection program.  These
as well as the Interim  Inspection Guidance prepared by PTSED, must be
carefully during the Section 5 Inspection program.
TSCA Inspection Manual                      A-3                    S«pcte=e:
VoluM Poor:  Section 5 Manual
-------
         EMCEBuflES KM HANOilNfi SECTION 5 cTl
MAILING OP PMN DATA PROM PTSED

    • PTSEO Compliance Monitoring Section will oversee the mailing of  PMN
      Inspection targeting packages to each region.  The package will  consist
      of a summary Target Sheet and any other pertinent support documents.
      In most cases this Information will be confidential.

    e PTSED's OCO will mall all CBI related to the Inspection targeting package
      directly to the regional OCO.  A non-CBI letter of receipt-will  be included
      1n each package for Immediate review, signature, and return by the OCO.

    e A non-CBI memorandum will be sent under separate cover to the region's
      Sect lor. C Inspection coordinator notifying him or her that CBI data was
      sent.

    e PTSEO OCO will notify each regional OCO by phone when the CBI Is to be
      mailed.

RECEIPT OF PMN DATA FROM PTSED

The Regional  Document Control Offleer/Assistant must:

    e Review each CBI package received from PTSED to ensure that the document
      control numbers and number of pages match up as Indicated 1n the letter
      of receipt.  If there 1s a discrepancy, notify the PTSEO OCO for
      clarification.

    e Sign and return the letter of receipt Immediately to the PTSED DCO.
      (A return address label will be Included for prompt mailing.)

    e Sign all document-cover sheets and fill 1n the date.

    e Be sure to use the OPTS document control number which will be assigned
      to each document.  (Some regions assign sequential numbers within their
      own numbering system and attach a different cover sheet whenever a CBI
      document 1s received 1n their office; the OPTS document number should
      also appear on those cover sheets.)

    e Participate 1n the pre-rev1ew meeting [see below: Pre-Inspectlon
      Activities • Pre-Rev1ew Meeting].  Brief all reviewers on security
      procedures for review of CBI and suggest that they refer to the
      appropriate sections of the TSCA CBI Security Manual and the TSCA
      Base Inspection Manual as a refresher.

In addition,  the Regional Document Control Officer/Assistant should:

    e  Become familiar with proposed regulations, interim policy statements ana
       enforcement policies under Section S, Including the types of Informa-
       tion that may be submitted and collected as CBI during Inspections.
TSCA Inspection Manual                       \-4                    Seperaber
Volga*. Poor:  Section 5 Maaoal
-------
                                                              SecorttT
    t  Become falmHar with security practices of each Individual  reviewer and
       establish working procedures for each person based'on this  knowledge.

    e  Request to be Informed prior to any Inspection activity of  the persons
       that will be Involved 1n each Individually targeted Inspection and/or
       review of a Section S CBI company file (Inspectors, attorneys. Branch
       Chiefs, etc.)*  Also request to be Informed of any major changes
       In program operation and/or program personnel  In the. event  that
       Section 5 CBI procedures may be affected.

     e Keep duplication of CBI to the bare minimum.  The security  manual  states
       that the original should remain with the OCO.   However, since  the  OCO
       will not receive the original, unless regional practice strictly prohibits
       1t, the OCO's copy can oe logged out without duplication.  Also, the
       transfer of CBI documents among authorized persons 1n different divisions
       should be kept to a minimum.  If more than one key person Is Involved
       In a Section 5 Inspection and the Individuals  are In separate  Divisions,
       1t may be necessary to make two separate copies to be logged out by
       each Division Instead of transferring documents.  This procedure will
       help to keep the DCO/DCA In direct control of  the chaln-of-custody of
       the CBI.

PRE-INSPECTION ACTIVITIES

Prior to a Section 5 Inspection, the Inspectors should assemble, and carefully
review the Information from PTSED concerning the company to be Inspected.  The
Information-will Include/ PTSED-Section S Target Sheet (summary sheet of  company)
and attachments. Including the PMN and THE forms and communications between the
company and OPTS.  Following are activities to be carried out by the Inspectors.

    Pre-Revlew Meetings

    e Conduct pre-revlew meetings upon receipt of all target Information from
      PTSEO.  Participants 1n the meeting should Include Inspectors, OCO/OCA,
      attorneys, secretaries who will type CBI, and all other persons Mho Mill
      review or receive CBI.  The meeting should Include discussions of the
      Individual responsibilities of persons Involved 1n the Section S Program,
      and of the following topics as they relate to CBI:

         overall background and proposed objectives of the program;
         number of Inspections that will be performed;
         who will perform which inspections;
         who will need a copy of which document(s);
         types of CBI documents that will be generated from the reviews;
         types of Information (especially CBI)  that will be taken
         on the Inspection;
         typing load and typing system for CBI;
         refresher C?! briefing by OCO/OCA; and
         schedule for similar review meetings.
TSCA Inspection Manual                      S^5                     September
       Four:  Section 5 Manual
-------
 Appendix  2             	             	               Security Pracadurt
 Revtew  In CBI Roe»

 •  Request access  to the CBI  information from the OCO/OCA.  Be sure to sign the
   document cover  sheet of each document reviewed.  Because of the sensitivity
   of the PMN Information, the Information should be reviewed 1n the OCO
   room  or a room  assigned for CBI reviews.  Bring necessary regulations,
   guidances, and  notepads for the review.

 Slqnout of CBI Documents I

 e  When  1t 1s Impractical for review of the Information 1n the OCO room, the
   documents may need to be logged out.  Persons without approved storage must
   return the Information to the OCO by close of business each day.  Persons
   with  approved storage can log Information out overnight.

   In either situation, the following supplemental procedures and precautions
   should be followed:

   • Sign cover sheet and the OCO/OCA log out/sign out sheet. (This -log sheet
    1s  maintained  on file until the document 1s returned.)

   • Obtain a current list of authorized persons from the OCO to ensure
    that CBI data  1s shown only to other authorized personnel.

   - When the Section & Information Is logged out overnight, ensure that the
    DCO/DCA has the combination to the file 1n which the Information will
    be  secured.?   If that Information will be filed 1n an approved storage
    where more than one other person has the combination or where other
    categories of  CBI 1s filed, some type of Identification should be
    present on the folder or envelope to flag the content's.  This identi-
    fication should help to avoid unnecessary handling of Section 5
    Information by authorized persons without a specific need to know.

  • Keep document(s) under constant surveillance so that direct security
    control can be-exercised over the document when 1t Is out of the file.

  • Lock the document In the approved storage area when It Is not actually
    being reviewed.

  • Discuss CBI only with or 1n the presence of authorized persons.

  • Discuss PMN Information with an authorized person only If there
    1s  an absolute need to know.

Review  of CBI by Others

e After logging out a document from the OCO/OCA, ensure that all other  persons
  reviewing 1t are Identified on the cover.sheet:

  • Ensure that all other persons who review the document, sign the  cover
    sheet of each  document reviewed.  Coordinate group reviews with  other
    persons Involved with the Inspection so that a minimum number of separate
    reviews 1s needed and fewer CBI notes are  generated.
 TSCA Inspection Manuel                      A-6                    Septemo«r
 Velum* Four:  Section 3 Manual
-------
 Appendix 2 _ _ _ SacurltT


       •  Do not allow other persons to leave the room with the C8I document
         unless absolutely necessary.  If the person must take 1t:

       •  Have that person sign a loan receipt which constitutes a record that  ene
         document Is temporarily the responsibility of another person. (Even
         1f a person will not keep the document overnight, a loan receipt must
         be signed when the document will be out of the direct surveillance of
         the person who logged 1t out.)

       -  Give a copy of the loan receipt to the OCO»

       •  Be sure that that the person 1s familiar with the supplemental  review
         procedures under Section S.

    •  Provide the OCf with all generated CB! notes to be stamped and logged
       Into the
    Discussion of CBI on the Telephone

A blanket waiver has been approved to allow discussions of Section 5 CBI
by telephone.  A copy 1s attached as Appendix 2-A.  Although this waiver
has been granted, certain steps must be followed for dlscussslons between
EPA personnel :

    e Identify at the beginning of the conversation that Information about to.
      be discussed 1s CBI.  This will- allow the other party to properly document-
      the conversation.

    e Maintain a log of all telephone conversations containing CBI.

Additional Information for CBI telephone discussions 1s outlined below
under NOTIFICATION OF COMPANY.

    Travel With CBI

Decide 1f confidential Information needs to be taken on the Inspection.
As a security measure, the Inspector should take the minimum amount of
CBI on travel.  The Section 5 Target Sheet 1s designed to give the
Inspector all the summary Information that may be needed on a company.
If additional CBI Information such as a test marketing exemption application
will be needed during the Inspection, 1t 1s suggested that the Inspector
request that the company make such Information available.  (See below —
NOTIFICATION OF COMPANY.)   Before leaving on an Inspection return confidential
Section 5 documnt(s) that have been logged out and will not be taken on the
Inspection to the OCO before leaving.

If the Inspector needs to take CBI on an Inspection, adhere to the following
procedures:

    e Do not pack CBI 1n luggage that will be checked 1n at airport, train
      station, etc.

    e Oo not leave information In the briefcase or envelope unattended in trie
 TSCA Xa«p«eelea  MUMM!                       A-7                     S«ptamber
     H fbor:   Seetioa 3 Miami
-------
 Appendix 2	.	Security Procedure*


       hotel room.   Information  can  be secured  1n a  locked briefcase. 1n the
       trunk of a car.   However, hotel safes are preferred for overnight storage.

     • Do not carry CBI  1n  a  clearly marked "C8I" envelope 1n the event that the
       Briefcase Is opened  and the envelope 1s  exposed.  Briefcases containing C3I
       can be carried  into  a  restaurant.  Do not, however, review or discuss the
       CBI in a public place.  Information can  be reviewed In the privacy of a
       hotel  room when necessary.

     Documents and  Equipment

 Assemble other appropriate CBI  related forms and materials for the Inspection,
 Including:

       -  Inspection credentials
       •  letter of  authorization to  access CBI
       •  TSCA Inspection Confidentiality Notice
       -  chain of custody  records
       •  loose leaf note pad  specifically for CBI notes
       -  envelopes  addressed  to  OCO  (registered return receipt card should be
         attached)
       •  Declaration of Confidential Business Information form
       -  briefcase  with  lock
       •  copy of security procedures as reference
       -  other forms as outlined 1n  the TSCA Inspection Base Manual
       •  CBI  stamp  and Ink  pad (If available)

NOTIFICATION OF COMPANY

 In general,  the Inspector  will  telephone the company In advance of the
Inspection.   Contact should  be  made with the technical contact whose name
appears  on the Target Sheet  to  obtain Information on where to conduct the
Inspection and appropriate personnel with whom to meet.  An appointment should
be arranged  to ensure that the  appropriate officials and records will be avail-
able at  the  time of the Inspection.  (See Interim Inspection Guidelines
"Notification of Company"  for more  details.)

A blanket waiver has been  granted to the regions so that, when necessary, CBI
can be discussed with company officials as well as  notice managers 1n OPTS
headquarters.   The following procedure should  be followed when notifying tne
technical contact.

    e  Immediately  upon phoning  the  technical contact, request permission to
       discuss C8X  ovtr tht telephone.

    e  Give PMN number and  date  of submlttal and/or  the generic chemical name
       1f  PMN number 1s not familiar to the technical contact.

    e  The Inspector should also ask the company representative, at this time,
       to make available during  the  Inspection  copies of the CBI documents
       submitted to EPA under the Section 5 Program  which are the  subject of
       the Inspection.  This  procedure 1s a security measure which will  l
       the amount of CBI Information which Inspectors will need to carry.
 TSCA Inspection Manual                      A-3                    September
        Poor:  Soctloo 5 Manual
-------
    9 Ask If they want to claim any new Information they have provided during
      tha discussion as confidential.

    • Fill out telephone log of the conversation.  (This log 1s considered
      confidential.)
 If the technical contact does not grant permission to discuss Crt  over the
 telephone, explain why It Is necessary to do so. making the following points:

       • Inspection needs to be scheduled;
       • Documents claimed CBI by the firm could be made available at the
         inspection site to avoid the need for EPA to travel  with  such
         Information;
       - Ensure that the location of the site to be Inspected maintains the
         needed records or that appropriate records are transferred to the
         inspection site; and
       • Ensure that a company official authorized to make confidentiality
         claims Is available during the Inspection.

 If after explanation of need to discuss CBI, request 1s still not  granted,
 the Inspector should notify their Compliance Monitoring Coordinator In
 Headquarters, Compliance Monitoring Branch.  (The Inspector may have to submit
 questions In writing.)

 ENTRY

 The Inspector should. 1n addition to other required Inspection procedures,
 remember to:

    e Have letter of authorization to access CBI readily available.  (Letter
      should not be copied or leave the sight of the Inspector.)

OPENING CONFERENCE "

The inspector should clearly explain how EPA handles and documents Informal: :-
cl aimed CBI (A handout 1s attached for your use In Appendix 2-8).   It 1s to  •-
company's advantage to clearly and directly make confidentiality claims dur--:
the Inspection so that those notes /documents can bo written directly in CBI
note books and placed In designated envelopes.  Otherwise, the company has
 seven days after the Inspection within which to make the claim.  (This proc«:
 will also make the closing conference and declaration of confidentiality pr::-
 go smoothly, effectively and more securely.)

 The official at this point also has the opportunity to withdraw any previc.s
 claims of confidentiality for Information that has already been submitted •
 EPA.  The company must submit a letter, waiving confidentiality claim, to •  -
 OPTS OCO In EPA for each document which no longer requires CBI treatment.

 INSPECTION ACTIVITIES

 During the examination of records, Inspectors may view or copy documents
 that are considered confidential by the company.  It 1s recommended  that
 such documents be avoided unless they  are essential to the documentation
 of violations.  The Inspector should:


 TSCA Inspection Mmutl                       A-9                     S«pera: •
 VoluM Poor:   Section S
-------
Appendix  2                                                    SaeurtCT


    t Clw'rTy nark pr stamp Immediately each document claimed CBI during the
      Inspection.  Place documents Inside an envelope also narked "confidential
      business Information to be opened by addressee only." This envelope
      snould be placed Inside a plain envelope and mailed Immediately by
      registered mall to the Document Control Officer 1n the regional office
      after the Inspection when hand delivery 1s not possible.

    e Information claimed or suspected to be claimed confidential (either
      orally or copied) obtained from facility records, should be referenced
      In a non-confidential statement In the field notebook and the Information
      should be placed on separate sheets of paper that are then treated as CBI
      documents.  Photocopied documents should be referenced 1n the same manner.

    e To avoid difficulties arising from confidentiality claims surrounding photo-
      graphs, it 1s recommended that all unnecessary background be shielded
      when photographs are taken, or the subject may be craved to another area.
      It 1s recommended that Instant cameras which do not produce negatives
      be used.

CLOSING CONFERENCE

The Inspector must. In addition to other required Inspection procedures:

    e Review the company documents and samples obtained during the Inspection
      and list them on the "Receipt for Samples and Documents."   Reference
      listed documents In a non-confidential statement.  Review this list
      carefully with the company representative.

    e Prepare a complete 11st of all items declared CBI on the Declaration :'
      TSCA CBI form.  Facility officials must review and make any further en:--->s
      on the Declaration form.

    e Mall CBI documents by registered mall from a post office Immediately *.:
      the DCO when hand delivery 1s not possible.

INSPECTION REPORT

The Inspector should coordinate with the DCO/DCA to be sure uniform typing
procedures for CBI are followed and proper documentation of generated CBI
reports are logged Into the system.
 TSCA Inspection Manual                      A-10                   Sepcee:
        Four:  Section 5 Manual
-------
Apotndi» 2	.	Security Froc«dur«.


MISCELLANEOUS REMINDERS

      No private contractor assistance Is available undtr the Section 5
t No private
  Inspection
                 program.
    t Only DCOs/OCAs can make copies of CBI.  However, the regional  OCO
      Tsnot to duplicate Section S CBI for distribution to another
      region.  Contact the PTSEO HQ In cases when Section CBI needs to
      be sent to additional  regions.

    e Inspectors must contact the HQ Compliance Monitoring Coordinator if
      they want to challenge a company's confidentiality claims.
      Oeclasslflcatlon under Section 5 has not been redelagated to the
      regional  counsel, therefore coordination oust be made through HQ.

    e Ask the DCO/OCA for any further Information en CBI procedures.
      Violators of the security procedures by wrongful disclosure of CBI  are
      subject to criminal penalty under TSCA Section 14(d) 15 U.5.C.  Section
      2S13(d).
TSCA  Inspection Manual                       A-ll                    S«pttmb«r
Volume FOOT:  Secciea S M«WM!
-------
App€ndi*  2	__	SaeorltT
TSCA Inspection Hunul                     A-12                  S«pc«»b«r
   ta* FOOTS  teetira.S
-------
AoB«ndi« 2-A
                                                   S«COritT
(m)
  N.*^
 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

            WASHINGTON. O.C. 204*0
                             JU.20B8!
                                                          erne* or
                                                   *«iTicio«t AND TO«IC
MEMORANDUM

SUBJECT:
TO:
FROM:
Authorization Request for Communication  of  TSCA
Section S Confidential  Business Information over  the
Telephone

Ed Cull , Chief
Information Services Branch
Management Division

John S. Seitz, Chief
Compliance Monitoring Branch
Pesticides and Toxic Substance"
     The majority of Information submitted-to the agency under
Section 5, Including Premanufacture Notices (PMN) and Test  Mar
-------
App«odix 2*
     Upon approval of the  authorization,  the  following procedure
would be To 1 loved:

     EPA employees authorized  for  access  may,  when  necessary,
discuss TSCA Confidential  Business  Information related co  this
Section S Inspection program over  the  telephone with  other
authorized EPA employees or the  representative of the firm who
submitted the Information.  Any  such  Information discussed would
first be specifically Identified as TSCA  Confidential  Business
Information during the conversation.
                    TL
 pproved            /^ate           Disapproved              oTf
 TSCA Inspect lea Manual                   *-l*                S«pe«mO€r
      Pout: Se*tlo« S Mantel
-------
Aonendi« 2-B	Security Proceduree


Fact Sheet

TSCA Inspection Confidentiality


Right to Make Confidential Business Information Claims

Section 14 of the Toxic Subetencee Control Act (IS USC Sec. 2613) permits any manu-
facturer, processors, or distributor in commerce of chemical substances to claim as
confidential buaineaa information (CBX) any information submitted under tht Act  to
the U.S. Environmental Protection Agency (EPA).  EPA regulatione at 40 CFR Part  2
require that buaineaaea be notified of thia right when EPA requests or demands infor-
mation which might be entitled to confidential treatment; the regulations also detail
the notice and heering procedures to be followed if a public requeat is mads for such
information.

Section 14 and the regulations are designed to protect confidential business informa-
tion from unauthorized diacloaure.  Confidential buaineaa information includes infor-
mation considered to be trade secrets (including chemical identity, process, formula-
tion, or production data) that could damage a company1a competitive petition if  ie
became publicly known.

Information collected during en inepection would be made evartabla in response co a
Freedom of Information Act (FOXA) requeet unless the information ware determined to
be exempt from releese under strict FOIA criterie.  However, if the data has bma
claimed confidential business information by the company, EPA would follow ctrwiin
procedural stepe prior to releese of the information end the data would not be
releeaed at all if it waa determined to be entitled to confidential treatment.

TSCA Inapection Confidentiality Notice                                             ""

The TSCA Inapection Confidentiality Notice ia the company'a official notification of
the right to make confidentiality claima for materiel collected during a TSCA inspec-
tion.  It liats four criteria which must be mat by any information the company ciaiaa
confidentiel.  The Notice ahould be signed by the facility owner or egent in charge
at the time of the inspection to acknowledge receipt.

If no facility official ia present et the inspection site who is authorized to make
CBX claiaa, the Nocieo and accompanying forma (eee below) will be sent within cvo
days of the inspection to the Chief Executive Officer of the firm end another company
official, if designated.  Xn auch inatancee, CBX claima can be made by the  company
within seven days of receipt of the Notice.

How CBI Claima Are Made

Informaciom ia officially claimed CBX et the cloee of the inspection.  However,  u  is
strongly suggested thet, when available on-site, a company official authorized  co
make CBX claiaa accompany the inspector during the inspection to facilitate designa-
tion of confidential business date while the inspection is in progress;  this  off)
can also help the inspector avoid copying confidential information  not necessary :o
the purpoae of the inapact ion.

At the end of the inspection, the inapector will hold a closing conferenct  with
facility officiale.  Ac thia time, all documents, photographa, or physical  samples
taken during the inspection will be listed in detail on a Receipt  for Oocumtnci  a-a
Samples.


TSCA Inspection Manual                          A-15                   sepc«D«r
Volume Pour:  Section 5 Manual
-------
 Appendix 2-3                                                       Security


 The  auth«ffzcd  company  official  should  carefully review this  list and decide  which  :
 the  itema should  receive  confidential  treatment.   Each item to be claimed  confi- -
 dential  muat  meet all of  the following  criteria:

         •  The company has  taken  measures  to protect  the  confidentiality  of  the in-
             formation and it intenda  to continue to take such  messures;

         •  The information  is not, and haa not  been reasonably obtainable without
            the company's consent  by  other  persona (other  than governmental bodies)
            by  uae of legitimate means  (other than discovery based on a  showing of
            special need  in  a judicial  or quaai-judicial proceeding);

         e  The information  is not publicly available  elsewhere;  and

         e  Disclosure  of the information would  cauae  substantial harm to  the
            company's competitive  position.

 Such  itema  should be liated  on the Declaration of TSCA Confidential Business  Informa-
 tion  form and the facility official muat sign the form certifying that each  itea
 meeta the criteria.

 If no authorized  facility official is  en-site during the inspection, the Notice,
 Receipt  for Documents and Samples, and  Declaration form will be sent by  registered
 mail  to  the Chief Executive  Officer (and other deaignated  peraon) within tvo  day^af
 the  inspection.   CBI claima  in auch caaea may be made  by the company within seveog
 daya  by  regiatered mail.

 Security Meaaurea for Handling CBI

 Any  information claimed CBI  ia handled  under stringent security procedures.   The do
-------
     APPENDIX i



SAMPLING PROCEDURES;
-------
                                 SAMPLING PROCEDURES

The inspector does not routinely take samples during TSCA inspections.  However,  in some special
situations, obtaining samples may be the only way to determine if a facility is in compliance.  The
inspector should have a clear defined reason for obtaining the sample and discuss it with her/his
supervisor to determine if the sample should be taken.

If the inspector and her/his supervisor have determined that obtaining a sample of a chemical or mixture
in question is necessary, men the inspector should develop a sampling plan to ensure that the sample is
collected ami analyzed in such a fnmmer tf\s$ it can be used as evidence in an enforcement action.
Sampling Plan

The sampling plan should contain the elements discussed below.

       •     Represesentattve sample  -  The inspector must ensure that  the  sample collected is
              representative of the chemical substance or mixture. Therefore, the inspector must select
              the appropriate site (e.g., storage container, process tank, etc.)  and the appropriate
              number of samples.  The inspector should note the site selected  for sampling and provide
              additional documentation such as photographs or drawings of the sampling site.

       •     Proper equipment and procedures - The inspector should use the appropriate equipment
              and sample container. .^Various, substances and sample types require different types of
              equipment and sample  containers, so the inspector should check with the laboratory
              which will be performing the analyses to determine what is necessary. When preparing
              and using the equipment, the inspector should be extremely careful not to contaminate
              such equipment.   All  steps which  were followed hi preparing the equipment and
              collecting the sample should be carefully noted in the inspector's notebook.

       •     Sufficient sample volume - The inspector should also check with the laboratory which will
              be performing the analyses to determine the amount of volume needed. The amount
              should be sufficient to perform all required analyses plus an additional amount for quality
              control and repeat analyses.  Specific volumes vary with the type of sample and chemical
              substance or  mixture to be analyzed.  If the company wants a duplicate sample, the
              inspector should collect and handle the duplicate sample using the exact procedures used
              for collecting the official EPA sample.

       •     Sample Uenjfleatlon - The  following information should be recorded hi the inspector's
              notebook:

                     Sample number
                     Name of sampler
                     Time and date of collection
                     Collection method
                     Description of sample, including color, texture, viscosity, etc.
                     Analyses to be performed
                     Duplicate sample and to whom it was provided.
-------
A label should be affixed to the sample container with the following information:

        Sample number
        Time and date of collection
        Inspector's (i.e., sampler's) initials
        Sub-sample number if necessary.

After the sample has been collected and labeled, its container should be placed inside a
plastic bag  on which the inspector has written her/his initials, and the date. The bag
should then be turned inside out to prevent any means of tampering with the contents.
The bag is then taped in a secure manner with the Official Sample Seal (EPA Form 7500-
2). The seal is completed by:

        (1)     Inserting the sample number;
        (2)     Inserting the date;
        (3)     Printing the locator of the collector's station;
        (4)     Printing the name and tide of me person sealing the sample;
        (5)     Signature of the person sealing the sample; and
        (6)     If the company declares the sample as CBI, the seal should be marked
               "Confidential Business Information."
The sample container and wrapper should be sealed so that it may not be opened at any
point without breaking the seal and/or original package.  One seal should be used for one
sample.  If the seal is broken for any reason, the person breaking the seal should initial
the seal and write on it the date it was broken, mount h on a piece of paper, and submit
it with the sample records to provide a continuous history of the sample.  The sample
should then be reseated with a new seal.

Qiain-of-Custody - The inspector should complete the Chain-of-Custody record.  The
Chain-of-Custody record initiates the process that controls and records access to the
sample once it has left the inspector's possession. The sample number relates the sample
to the record  that accompanies  the sample  through the handling and analyses stages.
Chain-of-Custody is discussed in more detail in the next section.

Sample Handling - Samples must be handled, stored, and shipped properly to avoid loss.
contamination, danger to handlers,  and tampering. Requirements for handling specific
chemical or mixture samples include the following:

Samples should be handled according to appropriate safety procedures for the specif! >
chemical or mixture to be sampled.

Provisions for  sample preservation  (refrigeration,  chemical preservatives, prop*.
packaging, etc.) should be planned in advance of the actual sampling so the inspector h.
the appropriate equipment and sample container available.

The recommended holding times for specific samples should  be determined  and  ca
taken to avoid delays in sample transit.
-------
               Highly toxic materials require special handling, and such arrangements should be made
               in advance of the actual sampling.

               Security provisions should be appropriate for protecting the samples.

               Samples should be delivered directly to the laboratory  by the inspector whenever
               possible.  If this  is not possible, the  inspector should ship the sample by the most
               economical means considering the need for rapid handling (Le., the recommended
               holding time).  All shipments must be in accordance with the US Postal Service and
               Department of Transportation regulations.

               Handling and shipping procedures followed should be recorded to document the integrity
               of the sample.   Copies of all  shipping and handling documents (e.g., bills of lading,
               return receipts, etc.) should be obtained for inclusion in the inspection report as part of
               the sample
               The inspector should ensure mat all sampling activities have been clearly and adequately
               documented in her/his notebook.  All documents relating to the sample (i.e., Seals,
               Chain-of-Custody record, drawings, photographs, etc.) should be clearly marked with the
               sample number.

Chain-of-Custody

In any activity mat may be used to support litigation, EPA must be able to prove that any analytical data
offered as evidence hi a court accurately represent the conditions at the time of sample collection. It must
be demonstrated mat the samples collected were not tempered with or contaminated during collection,
transit, storage, or analysis.  An accurate written record must be maintained to trace the possession of
each sample from the moment of collection through analyses to its introduction as evidence.

The procedures which  are used to ensure  the  integrity of the sample are called chain-of-custody
procedures.  The chain-of-custody procedures begin with the identification of the sample and continue
through the laboratory analyses.  These procedures include the steps described below.

        1.     Establishing Custody - Sample custody is initialed atthe time of collection by sealing me
              sample with the EPA Official  Seal.

       2.     Preparing  Sample Documentation - A major aspect of the chain-of-custody is  the
              preparation and maintenance of written information describing the collection, shipment,
              and storage of the sample.  Preparation of this documentation is the responsibility of the
              inspector, any  other person involved  in the transit of the sample, and the laboratory
              personnel.  This documentation will serve as a clear, detailed account indjcflffag that the
              sample remained intact from collection through laboratory analyses to introduction as
              evidence. The  documentation includes the inspector's field notebook, me EPA Official
              Seal, and the Chain-of-Custody Record.

       3.     Coordinating Sample and Documentation • The inspector must ensure mat the sample
              number,  date,, and inspector's initials appear on all  documentation to ensure that the
              relationship between the sample and the documentation is clear, complete, and accurate.
              If the company  has declared the sample as CBI, die Seal, Chain-of-Custody record,  and
-------
       any analytical reports should be clearly marked as "Confidential Business Information"
       and treated as such. Also, the inspector should note that a sample claimed as CBI should
       only be delivered or sent to a laboratory individual who has been cleared for access to
       confidential information.  Each person who handles the sample and analytical report must
       also be cleared for CBI access.

4.     Ensuring Custody During Transit - Shipment of samples to the laboratory will involve
       the following procedures:

              Samples must be accompanied by the Chain-of-Custody Record.  Copies  of
              documents should be retained by the originator.

              If sent by common carrier,  a bill of lading should be obtained.

              All receipts and shipping documents should be included hi the Chain-of-Custody
              documentation.
-------
-------
                         Regional Pollution Prevention Contacts
 Region I
 Mark Mahoney/Abby Swaine
 Pollution Prevention Program
 U.S. EPA Region I (PAS)
 John F. Kennedy Federal Building
 Boston, MA 02203
 Mahoney:     Telephone:    617-565-1155
              FTS:         835-1155
              FAX:        617-565-3346
 Swain:        Telephone:    617-565-4523
              FTS:         835-4523
              FAX:        617-565-3346
Marv Rosenstein
33/50 Program
Chief, Pesticides and Toxic Substances Branch
U.S. EPA Region.I (APT)
John F. Kennedy Federal Building
Boston, MA  02203
Telephone:     617-565-3273
FTS:          835-3273
FAX:         617-565-4939
Region II
Janet Sapadin
Policy and Program Integration Branch
Office of Policy Aid Management
U.S. EPA Region U
26 Federal Plaza
New York, NY 10278
Telephone:    212-264-1925
FTS:         264-1925
FAX:         212-264-9695
Barbara Metzger
33/50 Program
Director, Environmental Services Division
U.S. EPA Region D (MS 100)
2890 Woodgridge Avenue, Building 10
Edison, NJ  08837-3679
Telephone:     908-340-6754
FTS:          340-6754
FAX:         908-342-4381
Region m
Roy Denmark
Pollution Prevention Coordinator
Environmental Assessment Branch
Environmental Services Division
U.S. EPA Region in
841 Chestnut Building (3ES43)
Philadelphia. PA 19107
Telephone:    215-597-8327
FTS:          597-8327
FAX:         215-597-7906
Bill Reilly
33/50 Program
Special Assistant
Air, Radiation and Toxics Division
U.S. EPA Region m (MS 3ATOO)
841 Chestnut Building
Philadelphia, PA  19107
Telephone:    215-597-9302
FTS:          597-9302
FAX:         215-597-7906
-------
Region IV	

Carol Monell
Chief, Pollution Prevention Unit
Policy. Planning, and Evaluation* Branch
Office of Policy and Management
U.S. EPA Region IV
345 Courtland Street, NE
Atlanta, GA 30365
Telephone:     404-347-7109
FTS:          257-7109
FAX:         404-347-1043
Ion D. Johnston
33/50 Program
Chief, Title n and Toxics Section
U.S. EPA Region IV
345 Courtland Street, NE
Atlanta, GA  30365
Telephone:     404-347-1033
FTS:          257-1033
FAX:         404-347-1681
Region V
Louis Blume
Pollution Prevention Coordinator
Planning and Budgeting Branch
Policy and Management Division
U.S. EPA Region V
77 West Jackson Blvd.
Chicago, JL 60604-3590
Telephone:    312-353-4135
FTS:          353-2000
FAX:         312-886-5374
Dennis Wesolowski
33/50 Program
Acting Chief, Asbestos Control Section
Environmental Science Division
U.S. EPA Region V (MS 5SPT)
230 S. Dearborn Street
Chicago, IL 60604
Telephone:     312-886-6879
FTS:          886-6879
FAX:         312-886-2591
Region VI
Laura Townsend
Pollution Prevention Coordinator
Office of Planning and Evaluation
U.S. EPA Region VI
1445 Ross Avenue (6M-P)
Dallas, TX 75270
Telephone:    214-655-6525
FTS:          255-6525
FAX:         214-655-2146
Lewis Robertson
33/50 Program
U.S. EPA Region VI (MS 6T-P)
1445 Ross Avenue, Suite 1200
Dallas, TX  75202
Telephone:     214-655-7235
FTS:          255-7235
FAX:         214-655-2164
-------
Region VH	

Alan Wehmeyer, Deputy Director
Waste Management Division
U.S. EPA Region VH
726 Minnesota Avenue
Kansas City, KS 66101
Telephone:    913-551-7336
FTS:          276-7336
FAX:         913-551-7063
Carl Walter
33/50 Program
Deputy Director, Air and Toxics Division
U.S. EPA Region VU (MS ARDQ
726 Minnesota Avenue
Kansas City, KS 66101   .
Telephone:    913-551-7020
FTS:         276-7020
FAX:        913-551-7063
Region VIH
Don Patton, Chief
Sharon Childs, Program Analyst
Policy Office
U.S. EPA Region Vm
999 18th Street, Suite 500
Denver, CO  80202-2405
Patton: Telephone:     303-293-1456
       FTS:          330-1456
       FAX:          303-293-1198
Childs: Telephone:     303-293-1454
       FTS:          330-1454
       FAX:          303-293-1198
Laura Lonowski
33/50 Program
Toxic Release Inventory Program
U.S. Region Vm (MS 8AT-TS)
999 18th Street, Suite 500
Denver, CO 80202-2405
Telephone:     303-293-1735
FTS:          330-1735
FAX:         303-293-1229
Region IX
Jesse Baskir, Program Coordinator
Alisa Green, Program Coordinator
Pollution Prevention Program
U.S. EPA Region DC
75 Hawthorne Street (H-l-B)
San Francisco, CA 94105
Baskir: Telephone:    415-744-2189
       FTS:         484-2189
       FAX:        415-744-1796
Greene:Telephone:    415-744-2190
       FTS:         484-2190
       FAX:        415-744-1796
Mark Samolis
33/50 Program
Environmental Scientist
U.S. EPA Region DC (MS A-4)
75 Hawthorne Street
San Francisco, CA  84105
Telephone:    415-744-1139
FTS:         484-1139
FAX:        415-744-1073
-------
Region X	

Carolyn Gaogmark
Pollution Prevention Coordinator
Policy, Planning, and Evaluation Branch
U.S. EPA Region X
1200 Sixth Avenue (MD-142)
Seattle, WA  98101
Telephone:     206-553-4072
FTS:          339-4072
FAX:         206-553-4957
Gil Haselberger
33/50 Program
Chief, Toxic Substances Section
U.S. EPA Region X (MS AT-083)
1200 Sixth Avenue
Seattle, WA  98101
Telephone:     206-442-1094
FTS:          399-1094
FAX:         206442-0110
-------

-------
                            BTTT.Vfl  fwmULm  IGDBVI  •  0C/1O/4A
                 Office  of  Toxic  substances  (OTS)

                         eompilsd by the
              Existing Chemical Assessment Division
                    Chemical Screening Branch

     The CORK database are lists of chemical substances, chemical
categories, and mixtures that are or have been the subject of
proposed or final OTB- regulations*

     Individual chemical substances that have a\ Chemical
Abstracts Service (CAS)  Registry Number are listed by CAS number
in ascending order.  Following the CAS number ordered list, is a
list of Premaaufacture Notice (FMB) substances listed in PMH
number order.  Following this FMH list, is an alphabetical list
of categories, mixtures, and chemical substances with no assigned
CAS number.  Those category members that were individually listed
in the Federal Register  (FR) or in any subsequent question and
answer document are included in the CAS number ordered list.

     Each listed substance, mixture,  and category is followed by
one or more rule codes.   For example:

     a s  TSCA section 8(a) chemical-specific rules (final rule).

     e s  TSCA section 8(e) requests for records and reports
          regarding significant adverse reactions.

     d s  TSCA section 8(d) rules requiring the submission of
          unpublished health and safety studies (final rules).
     e s  TSCA section 12(b) export notification rules (proposed
          and final rules).

     f s  TSCA section 4(f) required actions.

     m s  TSCA section 8(a) comprehensive Assessment Information
          Rules fCAZR) (final rules).

     p s  TSCA section 8(a) Preliminary Assessment Information
          Rules (PAIR) (final rules).

     r s  Substances subject to reporting period terminations
          under model 8(d)  rule.

     s s  TSCA section 5 significant new use rules (SNURs) on new
          and existing chemicals (proposed and final rules).

 arlio s  List of hazardous substances under §104(i) of the
          Comprehensive Environmental Response, Compensation, and
          Liability Act  (CBRCLA or superfund) as amended by
          SARA §110.

 sr313 s  List of toxic chemicals under §313 of the Emergency
          Planning and Community Right-to-Know Act (EPCRA or SARA
          Title III).

     t s  TSCA section 4 test rules and consent orders  (proposed
          and final rules).

     x s  TSCA section € risk management rules (proposed and
          final rules).
-------
                                   CORR - 06/30/90  (continued)


     The rule codes are explained IB tho Index to the Rule Codes,
which appears at the back of the CORR list*.  The index
provides:  Federal Register  
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
"\S NUMBER
l-OO-O
50-32-8
51-28-5
51-75-2
51-79-6
52-68-6
53-70-3
53-96-3
54-11-5
55-18-5
"-21-0
-63-0
56-23-5
56-38-2
56-55-3
57-12-5
57-14-7
57-56-7
57-57-8
57-74-9
58-89-9
CHEMICAL NAME
Formaldehyde
Benzo[a]pyrene
2 , 4-Dinitrophenol
Nitrogen mustard
aka: Mechlorethaaine
Urethane
Trichlorfon
Oibenzo [ a , h ] anthracene
2-Acetylaainofluorene
Nicotine
N-Nitrosodiethylanine
Benzanide
Nitroglycerin
Carbon tetrachloride
Parathion
aka: DNTP
Benzo [ a ] anthracene
Cyanide
1, 1-Dimethylhydrazine
Hydrazinecarboxamide
beta-Propiolactone
Chlordane
Lindane
RULE CODE
srllO
f2
sr313
srllO
srllO
sr313
srllO
sr313
S3
sr213
sr313
srllO
sr313
t35*
sr31
sr313
sr313
srllO
sr313
srllO
sr313
srllO
srllO
sr313
sr313
ml
sr313
sr3l3
sri : 3
sr3 : l
                                         (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES' (CAS) NUMBERS & CHEMICAL NAMES
LISTED BY CAS NUMBER
CAS NUMBER
59-50-7
59-89-2
60-09-3
60-11-7
60-34-4
60-35-5

60-57-1
62-44-2
62-53-3



62-55-5
62-56-6
62-73-7
62-74-8
62-75-9

63-25-2

64-67-5

65-85-0
67-56-1

67-63-0




CHEMICAL NAME

p— ChlOtO— B— ClTOSOl
N-Nitrosomorphol ine
4-Aninoazobenzene
4-Dinethylafflinoazobenzene
Methy Ihydraz ine
Acetaaide
aka : Ethananide
Oieldrin/aldrin
Phenacetin
Benzenanine
aka: Aniline


Thioacetamide
Thiourea
Dichlorvos
Acetic acid, fluoro-, sodium salt
N-Nitrosodimethylaoine

Carbaryl
aka: Sevin
Sulfuric acid, diethyl ester
aka: Diethyl sulfate
Benzoic acid
Methanol

2-Propanol
aka: Isopropanol
Isopropyl alcohol


RULE CODE
srlio
sr313
sr313
sr313
sr313
ml
sr313
srllO
t35*
dl
t42
srllO
sr3l3
sr313
sr313
sr313
dl6
srllO
sr313
srllO
sr313
Pi
sr313
srllO
srllO
ST313
C40
pis
d!9
sr:: :
ts:
                                         (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
— ,S NUMBER CHEMICAL NAME RULE CODE
-64-1

67-66-3


67-72-1




68-12-2


68-76-8
70-30-4
71-36-3
71-43-2

-55-6




72-20-8
72-43-5

72-55-9
72-57-1



74-83-9



Acetone

Methane, trichloro-
aka? Chloroform

Ethane, hexachloro-




Dimethyl fomanide
aka: DMF
Formamide, N,N-dimethyl-
Triaziquone
Hexachlorophene
n-Butyl alcohol
Benzene

Ethane , 1,1, 1-tr ichloro-
aka: Methyl chloroform



Endrin
Methoxychlpr

4, 4 '-DDE, DDT, ODD
2,7-Naphthalenedisulfonic acid, 3, 3 '-[ (3, 3 '-dimethyl
[ 1,1' -biphenyl] -4,4' -diyl) bis (azo)] bis[ 5-amino-4-
hydroxy-tetrasodium salt
aka: Trypan blue
Methane, bromo-
aka : Bromomethane
Methyl bromide

srllO
sr313
srllO*
d20
sr313
srllO
P3
d3
rl
sr313
P21
d25
srllO
sr313
t35*
sr31-
srllO'
sr313
srllO
Pi
dl
tl
sr313
t35
srllO
sr313
srllO
t35*
Pi
dl

P21
srllO
d20
sr3l3
                                         (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
CAS NUMBER
74-85-1
74-87-3
74-88-4
74-90-8
74-93-1
74-95-3
74-97-5
75-00-3
75-01-4
75-02-5
75-04-7
75-05-8
75-07-0
75-09-2
CHEMICAL NAME
Ethylene
Methane, chloro-
aka: Methyl chloride
Methyl iodide
Hydrogen cyanide
aka: Hydrocyanic acid
Methanethiol
Methane, dibromo-
aXa: Methylene bromide
Methane/ bromochloro-
Ethane, chloro-
aka: Ethyl chloride
Vinyl chloride (nononer)
Ethene, fluoro-
aka: Vinyl fluoride
Et hanan ine
Acetonitrile
Acetaldehyde
Methane, dichloro-
aka: Methylene chloride
RULE CODE
sr3l3
t35
srllO
t!7
pi
dl
sr3l3
tso
sr313
pl8
sr313
t35
tso
t35
d20
sr313
tso
srllO
d20
P21
srllO
d20
sr313
t54
srllO
sr313
t23
P3
dl
t52
d20
Pi
dl
sr313
sr3l3
f4
srllO*
                                         (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
  .S NUMBER   CHEMICAL NAME
75-12-7



75-15-0



75-21-8





75-25-2





75-27-4




  -29-6

  -34-3





75-35-4




75-37-6



75-38-7
75-43-4



75-44-5
Fonnanide
Carbon disulfide
Oxirane
 aka:  Ethylene oxide
Methane, tribromo-
 aka:  Broaoform
Methane, bromodichloro-
 aka:  Dichlorobromonethane
Propane, 2-chloro-

Ethane, 1,1-dichloro-
1,1,-Dichloroethylene
 aka:  Vinylidene chloride
       1,1-Dichloroethene

Ethane, 1,1-difluoro-
Ethene, 1,1-difluoro-
 aka:  Vinylidene fluoride
Methane, dichlorofluoro-
 aka:  Dichloromonofluoromethane

Phosgene
Pi
d3

srlio
sr313

srllO
Pi
dl
sr313

srllO
t35
d20
sr313
d20
sr3l3

d20

srllO
t35
d20
t54

srllO
t20
sr313

p21
d25

t23
Pi
dl
t52

P21
sr '
t:
sr
                                                    (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER   CHEMICAL NAME                                       RULE CODE
75-45-6      chlorodifluoromethane                                  p21
                                                                    d25
                                                                    srllO
75-52-5      Methane, nitro-                                        p21
                                                                    d25
75-55-8      Propyleneiaine                                         sr313
75-56-9      Oxiraner methyl-                                       pi
              alca:  Propylene oxide                                 dl
                                                                    t5
                                                                    sr3I3
75-63-8      Broaotrifluoromethane                                  sr3l3#
              aka: Halon 1301
75-65-0      tert-Butyl alcohol                                     sr313
75-68-3      Ethane, l-chloro-l,l-difluoro-                         p2l
                                                                    d25
75-69-4      Fluorotrichloroaethane                                 srllO
              aka: Trichlorofluoromethane                           sr313#
                   CFC-11
75-70-7      Trichloromethanethiol                                  t35
75-71-8      Diehlorodifluoromethane                                srllO
              aka: CFC-12                                           sr313#
75-86-5      Propanenitrile, 2-hydroxy-2-methyl-                    dl6
75-87-6      Chloral                                                t35*
75-88-7      Ethane, 2-chloro-l.l,l-trifluoro-                      s55
              aka: 2-Chloro-l,l,l-trifluoroethane                   d28
                   HCFC-133a
76-01-7      Pentacfaloroethane                                      t35
                                                                    S4
76-13-1      Ethane, l,l,2-trichloro-l,2,2-trifluoro-               d25
              aka:  Freon 113                                       sr:::>
                    Chlorinated fluorocarbon                        sr'i3
76-14-2      Oichlorotetrafluoroethane                              sr   '=
              aka: CFC-114
                                                    (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED EY CAS NUMBER
NAMES
IS NUMBER
>-15-3

76-44-8

77-47-4




77-58-7

77-78-1

77-83-8

78-30-8

78-32-0

-J-33-1

78-40-0
78-42-2
78-51-3
78-59-1


78-83-1

78-84-2
78-87-5




CHEMICAL NAME
(Mono) chloropentaf luoroethane
aJca: CFC-lis
Heptachlor (and for SARA section 110 Heptachlor/
Heptachlor epoxide)
1 , 3-Cyclopentadiene , 1,2,3,4,5, 5-hexa-chloro-




Dibutyltin dilaurate
aka : Stannane , dibutylbis [ ( 1-oxododecyl ) oxy ] -
Sulfuric acid, dimethyl ester

Oxiranecarboxylic acid, 3-methyl-3-phenyl-,ethyl
ester
Phosphoric acid, tris(2-methylphenyl) ester

Phosphoric acid, tris(4-methylphenyl) ester

Phenol, 4-(l,l-dimethylethyl)-, phosphate (3:1)

Phosphoric acid, triethyl ester
Phosphoric acid, tris(2-ethylhexyi) ester
Ethanol, 2 -but oxy-, phosphate (3:1)
2-Cyclohexen-l-one, 3,5, 5-trimethyl-
aka : Isophorone

1-Propanol, 2 -methyl -
aka: Isobutyl alcohol
Isobutyraldehyde
Propane , 1,2 -dichloro-




RULE CODE
sr313*

srllO*
sr3l3
srllO
rl*
Pi
dl
sr313
P7
d2
pi.
sr313
Pi
dl
Pi
dl
Pi
dl
Pi
dl
c2
C2
c2
srllO
Pi
dl
d!6

sr313
srllO
Pi
dl
til
sr313
                                         (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL
                           LISTED  BY CAS NUMBER
                                                  NAMES
CAS NUMBER
78-88-6
78-92-2
78-93-3


78-97-7
78-99-9
79-00-5


79-01-6
79-06-1
79-10-7
79-11-8
79-19-6
79-21-0
79-22-1
79-24-3
79-27-6
79-34-5


CHEMICAL NAME
1-Propene , 2,3 -dichloro-
sec-Butyl alcohol
2-Butanone
aka: Methyl ethyl ketone

Propanenitrile, 2-hydroxy-
Propane , 1 , 1-dichloro-
Ethane , 1,1, 2-trichloro-


Triehloroethylene
aka: Trichloroethene:
2 -Propenanide±
aka : Acrylaaide-

Acrylic acid
Chloroacetic acid
Thiosemicarbazide
Peracetic acid
Methyl chlorocarbonate
Ethane, nitro-
Ethane , 1,1,2, 2-tetrabromo-
Ethane , 1,1,2,2 -tetraehl oro-


RULE CODE
t50
sr313**
d20
sr313
srllO
Pi
dl
sr313
d20
d!6
P21
srllO
d20
ST313
srllO
sr313
Pi
dl
sr313
sr313
sr313
t35*
sr313
t35*
P21
d25
ml
srllC
d20
sr313
t54
79-44-7
Dimethylcarbamyl chloride
sr313
                               8
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
LISTED BY CAS NUMBER
tS NUMBER
•^^^•^^^•^^•^••^^^^^^•^H
79-46-9
79-94-7


79-95-8
80-05-7



80-15-9

80-62-6



81-07-2

CHEMICAL NAME
2 -Nitropropane
Tetrabronobisphenol A
aka: Phenol, 4,4'-(l-methylethylidene)bis
[2,6-dibromo-

Tetrachlorobisphenol A
Phenol , 4 , 4 ' - ( 1-methylethylidene) bis-
aka: Bisphenol A


Hydroperoxide , 1-methyl-l-pheny lethyl-

2-Propenoie aeidr 2 -methyl-, methyl ester
aka: Methyl methacrylate


Saccharin (manufacturing)

RULE CODE
sr313
t31
t33
pl2
d!2
t31
p6
d8
t!2
sr313
d!6
sr313
d25
srllO
Pi
sr3I
t35*
sr313
 L-21-0      2,4-Methano-2H-indeno[l,2-b:5,6-b']bisoxirene,
               octahydro-
81-88-9      C.I. Food Red 15s
82-28-0      l-Amino-2-methylanthraquinone
82-68-8      Quintozene
              aka:  Pentachloronitrobenzene
83-32-9      Acenaphthene
84-61-7      1,2-Benzenedicarboxylic acid, dicyclohexyl ester
                                                       Pi
                                                       sr3l j
                                                       sr:: i
                                                       sr? . '
84-64-0
84-65-1
1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester
Anthraquinone
 aka:  9,10-Anthracenedione
                                                    (06/30/90)
-------
           CHEMICAL-ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                           LISTED BY CAS NUMBER
                                                  NAMES
CAS NUMBER
84-66-2



84-69-5

84-74-2





84-75-3

84-76-4
84-78-6
85-01-8

85-22-3



85-44-9

85-68-7


CHEMICAL NAME
1 , 2-Benzenedicarboxylic acid ,
aka: Diethyl phthalate


1, 2-Benzenedicarboxylic acid.
ester
1 , 2-Benzenedicarboxylic acid,
aka: Dibutyl phthalate
Di-n-butyl phthalate



1, 2-Benzenedicarboxylic acid.
aka: Di-n-hexyl phthalate
1, 2-Benzenedicarboxylic acid.
1, 2-Benzenedicarboxylic acid.
Phenathrene

Benzene, pentabromoethyl-



Phthalic anhydride

1, 2-Benzenedicarboxylic acid.
ester
aka: Benzyl -butyl phthalate

diethyl ester



bis ( 2 -methy Ipropy 1 )

dibutyl ester





dihexyl ester

dinonyl ester
butyl octyl ester








butyl phenylnethyl


RULE CODE
srllO
Pi
dl
sr313
dl

t44
srllO
t35**
Pi
dl
sr313
t44
dl
dl
dl
ml
srllO
S50
t30
P9
dlO
«?•••
sr : . :
sr '. .
t:-
F-
85-69-8



85-70-1
       BBP
       Butylbenzyl phthalate

1,2-Benzenedicarboxylic acid, butyl 2-ethylhexyl
  ester

1,2-Benzenedicarboxylic acid, 2-butoxy-2-oxyethyl
  butyl ester
86-30-6
N-Nitrosodiphenylamine
86-73-7
Fluorene
                             10
                                      (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
IS NUMBER
86-74-8
87-10-5
87-61-6
87-62-7
37-63-8
87-65-0
87-68-3

87-86-5
88-04-0
1-06-2
88-74-4
88-75-5
88-89-1
89-13-4
89-63-4
90-04-0
90-13-1
CHEMICAL NAME
9H-Carbazole
3,4, 5-Tribromosalicylanilide
Benzene , 1,2,3 -tr ichloro-
2,6-Xylidine
Bensenaaine, 2-chloro-6-methyl-
2 , 6-Dichlorophenol

Pentachlorophenol
aka: PCP
Phenol , 4-chloro-3 , 5-dimethyl-
aka: p-Chloro-m-xylenol
2,4, 6-Triehlorophenol
Benzenamine, 2-nitro-
aka: 2-Nitroaniline
o-Nitroaniline
2-Nitrophenol
Picric acid
1,2-Benzenedicarboxylic acid, 2-ethylhexyl-8-
methylnonyl ester
Benzenaaine, 4-chloro-2-nitro-
o-Anisidine
Naphthalene, 1-chloro-
RULE CODE
d!6
t31
Pi
dl
t8
sr313
s49
t31
srllO
Pi
dl
sr313
srl
sr3
P21
d25
srllO
sr313
srllO
t42
Pi
dl
srll(3
sr313
sr313
dl
Pi
dl
sr313
r2
a5
Pi
                  11
(06/30/90)
-------
CHEMICAL. ABSTRACT SERVICES  (CAS) NUMBERS £ CHEMICAL NAMES
                LISTED BY CAS NUMBER
CAS NUMBER CHEMICAL NAME RULE CODE

90-42-6
90-43-7
90-94-8
91-08-7



91-20-3


91-22-5
91-57-6
91-58-7

91-59-8
91-92-9

91-94-1

91-96-3

91-97-4

92-49-9
92-52-4




92-66-0

92-67-1

[1,1' -Bicyclohexyl ] -2 -one
2 -Pheny Iphenol
Michler's ketone
Benzene, 1, 3-diisocyanato-2-methyl-
aka : Toluene-2 , 6-diisocyanate


Naphthalene


Quinoline
2 -Methy 1 naphthalene
Naphthalene, 2-chloro-

beta-Naphthylaaine
2 -Naphthalenecarboxaaide , N , N ' - ( 3 , 3 • -diaethoxy
[1,1' -biphenyl ] -4 , 4 ' -diyl ) bis [ 3-hydroxy-
3,3' -Dichlorobenzidine

Butanamide ,. N , N ' - [ 3 , 3 ' -dimethyl (1,1' -biphenyl ) -4 , 4 '
-diyl] bis [3-oxo-
1,1' -Biphenyl , 4,4' -diisocyanato-3 , 3 ' -dimethyl -

Benzenamine , N- ( 2-chloroethyl ) -N-ethyl-
1,1-Biphenyl




1*1' -Biphenyl , 4 -brono-
alca : 4 -Bromobipheny 1
4 -Aainob ipheny 1
dl
d20
sr313
sr313
ml
C2
d20
sr313
srllO
d20
sr313
sr313
srllO
as
dl
sr313
dl

srllO
sr313
dl

c2
d20
Pi
Pi
d3
t4
sr313
tso
S5

sr2 . :
12
                                         (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
CAS NUMBER
92-69-3
92-84-2
92-86-4

92-87-5


92-93-3
93-00-5

93-72-1

93-76-5
94-36-0
94-58-6

94-59-7
94-75-7



94-82-6
95-14-7

95-39-6

95-47-6


95-48-7



CHEMICAL NAME
[l,l'-Biphenyl]-4-ol
10-H-Phenothiazine
l,l'-Biphenyl, 4 , 4 ' -dibromo-
aka : 4,4' -Dibrooobiphenyl
[1,1' -Biphenyl ] -4-4 ' -diamine
aka: Benzidine

4-Nitrcbiphenyl
2 -Naphthalene sulfonic acid, 6-amino-
aka: Broenner's acid
2,4,5-TP acid
aJca: Silvex
2,4,5-T
Benzoyl peroxide
Dihydrosafrole

Safrole
2,4-Dichlorophenoxyacetic acid
aka: 2,4-D
(srllO includes salts and esters).

2 , 4 -Dichlorophenoxybutyr ic acid
IH-Benzotriazole
aka: 1,2,3-Benzotriazole
2-Propenoic acid, bicyclo [2.2.1 ]hept-5-en-2-
ylmethyl ester
Benzene , 1,2 -dimethy 1 -
aka: o-Xylene

Phenol, 2-methyl-
aka: o-Cresol


RULE CODE
d20
d20
s5

srllO
d20
sr313
sr313
ml

srllO

srll
sr3I
t35
tso
sr313
srllO
t35
sr313
t31*
t31*
P21
d25
Pi

Pi
dl
sr313
srllO
Pi
dl
t9
                  13
(06/30/90)
-------
CHEMICAL-ABSTRACT SERVICES (CAS) NUMBERS 6 CHEMICAL NAMES
                LISTED BY CAS NUMBER
CJ JMBER

95-49-8

95-50-1







95-51-2


95-53-4

95-54-5



9 -8
95-63-6


95-69-2
95-70-5

95-76-1


95-77-2
95-80-7


95-82-9

CHEMICAL NAME

Benzene* l-chloro-2-aethyl-

Benzene , 1 , 2-dichloro-







Benzenamine, 2-chloro-
aka: 2-Chloroaniline

Benzenaaine, 2-methyl-
aka: o-Toluidine
1 , 2-Benzenedianine
aka: o-Phenylenediamine
o-Diaainobenzene
o-PDA
2 -Chlorophenol
Benzene , 1,2, 4-triaethyl-


Benzenaaine, 4-chloro-2-methyl-
1 , 4-Benzenediamine, 2-methyl-
aXa : 2 , 5-Dianinotoluene
Benzenaaine , 3 , 4-dichloro-
aka: 3,4-Dichloroaniline

3 , 4-DiehlorophenoI
1,3-Benzenediaaine, 4 -me thy 1-
aka: l,3-Diaaino-4-methylbenzene

Benzenaaine , 2 , 5-dichloro-

RULE CODE
sr3l3
pi
d3
srllO
t35
pi
dl
ta
tio
sr313
tso
t42
Pi
dl
die
Sr313
t36
pi
d3
t52
srllO
pi
d3
sr313
S49
P3
d3
t42
Pi
dl
t31
P3
d3
sr313
pi
dl
                  14
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
CAS NUMBER
95-83-0
95-94-3


95-95-4

9S-C5-9
96-08-2
96-09-3
96-12-8
96-18-4
96-23-1
96-29-7
96-33-3
96-37-7


96-45-7
97-02-9
CHEMICAL NAME
1 , 2-Benzenediamine, 4-chloro-
aka: o-Phenylenediamine, 4-chloro-
Benzene , 1,2,4* 5-tetrachloro-


2,4, 5-Trichlorophenol

2-Propenoic acid, 2 -methyl-, 2-prcpanyl ester
7-Oxabicyclo [4.1.0] heptane , l-methyl-4-
( 2 -methy loxirany 1 ) -
Oxirane, phenyl-
aka: Styrene oxide
Propane , 1 , 2-dibromo-3-chloro-
Propane , 1,2, 3-trichloro-
1, 3-Oichloropropanol
2-Butanone, oxime
aka: Methyl ethyl ketoxine
MEXO
2-Propenoic acid, methyl ester
Cyclopentane, methy 1-


Ethylene thiourea
Benzenamine , 2,4 -dinitro-
aka: 2,4-Dinitroaniline
RULE CODE
T5 	
d3
t35
Pi
dl
tio
tso
srlio
t31
sr3l3
Pi
Pi
Pi
sr313
srl
Pi
sr3
srlio
d20
t35
tso
pl5
dl9
t43
Pi
sr313
t26*
P12
d!2
tso
t52
sr: . :
t-;:
P-
dl
                  15
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
C IMBER
9 -7
97-23-4
97-56-3
97-63-2
97-86-9
97-88-1
97-90-5
98-01-1
98-06-6
98-07-7
98-09-9
9 -1
98-56-6
98-73-7
98-82-8
98-83-9
98-86-2
98-87-3
CHEMICAL NAME
Phenol, 2,2'-thiobis[4,6-dichloro-
Phenol , 2,2' -methy lenebis [ 4 -chloro-
C.I. Solvent Yellow 3
2-Propenoic acid, 2 -methyl-, ethyl ester
aka: Ethyl methacrylate
2-Propenoic acid, 2 -methyl-, 2-methylpropyl ester
2-Propenoic acid, 2 -methyl-, butyl ester
aka: Butyl methacrylate
2-Propenoic acid, 2 -methyl-, 1,2-ethanediyl ester
2 -Furancarboxaldehyde
Benzene , ( 1 , 1-dimethy lethyl ) -
Benzene, trichloromethyl-
Benzenesulfonyl chloride
Benzene , 1- ( 1 , 1-dimethy lethyl ) -4-methyl-
aka: p-tert-Butyltoluene
PTBT
Benzene, l-chloro-4- (trif luoromethyl) -
Benzole acid, 4-(l, 1-dimethylethyl)-
aka? p-tert-Butylbenzoic acid
PTBBA
Benzene , ( 1-methylethy 1 ) -
aka: Cumene
1-Methylethylbenzene
Benzene , ( 1-methyletheny 1 ) -
Acetophenone
Benzene, dichloromethyl-
aka: Benzal chloride
RULE CODE
d20
d20
sr313
t35
Pi
tso
Pi
d25
Pi
Pi
d20
d20
Pi
sr3l3
d!6
a8
d!7
P3
d3
a8
d!7
tl8
P9
dlO
sr313
t50
d20
t35«-
Pi
s:
                  16
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
CAS NUMBER
98-88-4
98-95-3
99-09-2
99-28-5
99-29-6
99-30-9
99-35-4
99-56-9
99-59-2
99-65-0
99-87-6
100-01-6
100-02-7
100-21-0
100-25-4
CHEMICAL NAME
Benzoyl chloride
Benzene, nitro-
Benzenamine, 3-nitro-
aka : m-Nitroanil ine
2 , 6-Dibrono-4-nitrophenol
Benzenamine , 2-bromo-6-chloro-4-nitro-
Benzenaaine , 2 , 6-dichloro-4-nitro-
aka: 2 , 6-Dichloro-4-nitroaniline
1,3, 5-Trinitrobenzene
1 , 2 -Benzenediamine , 4 -nitro-
aka: o-Phenylenediaaine, 4-nitro-
5-Nitro-o-anisidine
Benzene, 1,3-dinitro-
aka: m-Oinitrobenzene
Benzene, l-methyl-4-(l-methylethyl)-
Benzenanine, 4-nitro-
aka: p-Nitroaniline
4-Nitroaniline
4-Nitrophenol
akat p-Nitrophenol
Terephthalic acid
Benzene , 1,4 -dinitro-
RULE CODE
Pi
sr313
srllO
t27
pi
dl
sr313
srllO
Pi
dl
t31
dl
t42
Pi
dl
srll
Pi
d3
sr313
sr313**
d20
t42
t35**
Pi
dl
P21
d25
srllO
t35
sr313
sr313
sr313**
   aka:  p-Dinitrobenzene
                  17
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
LISTED BY CAS NUMBER
C IMBER
1 1-3
100-41-4

100-42-5
100-44-7
100-48-1
100-51-6
100-54-9
100-70-9
1 5-4
101-14-4

101-43-9
101-55-3
101-61-1
101-68-8
101-77-9

CHEMICAL NAME
Cyclohexene, 4-ethenyl
aka: 4-Vinylcyelohexene
Benzene, ethyl-
aka: Ethyl benzene

Benzrne, ethenyl- (Styrene monomer)
aka: Styrene
Benzene, chloromethyl-
4-Pyridinecarbonitrile
Benzyl alcohol
3 -Pyr idinecarbonitr lie
2-Pyridinecarbonitrile
N-Nitrosopiperidine
4,4' -Methylenebis (2-chlorobenzenaaine)
aka : 4,4' -Methylenebis ( 2-chloroaniline)
MBOCA

2-Propenoic acid, 2 -methyl-, cyclohexyl ester
l-Bromo-4-phenoxybenzene
4,4' -Methylenebis (N, N-dimethylbenzenanine)
Benzene, 1,1' -nethylenebis [ 4-isocyanato-
aka: Methylenebis (phenylisocyanate)
MDZ
Benzenamine , 4,4' -methy lenebis-
aka: 4,4-Methylenedianiline
MDA

RULE CODE
pl8
d27
p23
srllO
p!6
d21
Pi
sr313
srllO
Pi
sr313
Pi
sr3l3
d20
srllO
r2
d20
d20
sr313
ml
srllO .
a7
sr313
Pi
srllO
t35*
sr313
c2
d20
sr313
fl
Pi
dl
sr313
101-80-4
4,4'-Diaminodiphenyl ether
sr313
                             18
                                       (06/30/90)
-------
           CHSHICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
101-84-8
101-90-6
102-71-6
103-11-7
103-23-1
103-65-1
103-71-9
103-85-5
104-49-4
104-51-8
104-76-7
104-94-9
105-16-8
105-60-2
105-67-9
CHEMICAL NAME RULE CODE
Benzene , 1,1' -oxybis-
aka: Diphenyl oxide
Oxirane, 2,2'-[l,3-phenylenebis(oxynethylene) ]bis-
Ethanol , 2 , 2 • , 2 •• -nitrilotris-
aka: Triethanolamine
2-Propenoic acid, 2-ethylhexyl ester
Bis(2-ethylhexyl) adipate
n-Propylbenzene
Benzene, isocyanato-
n-Phenylthiourea
Benzene , 1 , 4-diisocyanato-
Benzene, butyl-
1-Hexanol, 2-ethyl-
p-Anisidine
2-Propenoic acid, 2 -methyl-, 2-(diethylamino) ethyl
ester
2H-Azepin-2-one, hexahydro-
2 , 4-Dimethylphenol
P21
d25
Pi
dl
P21
d25
Pi
sr313
t54
Pi
t35*
C2
d20
d20
t22
d20
sr313
PJ-
d: :
sr .
106-40-1     Benzenamine, 4-brono-
106-42-3     Benzene, 1,4-dimethyl-
              aka:  p-Xylene
106-43-4     Benzene, l-chloro-4-methyl-

106-44-5     Phenol, 4-nethyl-
              aka:  p-Cresol
                             19                     (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                           LISTED BY CAS NUMBER
           NAMES
C IMBER


106-46-7






106-47-8



106-49-0
106-50-3




106-51-4




106-63-8
106-71-8
106-74-1
106-83-2
CHEMICAL NAME
1

Benzene, 1,4-dichloro-






Benzenamine, 4-chloro-
aka: 4-Chloroaniline


Benzenantine , 4 -methyl- .
1 , 4-Benzenedianine
aka: p-Phenylenediamine
p-Diaainobenzene
p-POA

2 , 5-Cyclohexadiene-l , 4-dione
aka: Quinone
p-Benzoquinone


2-Propenoie acid, 2-methylpropyl ester
2-Propenoie acid, 2-cyanoethyl ester
2-Propenoic acid, 2-ethoxyethyl ester
Oxiraneoctanfeic iciaV~3-octyl-, butyl ester
RULE CODE
t9
sr3l3
srllO*
t35**
Pi
dl
t8
tio
sr313
srllO
t42
Pi
dl
d!6
t36
Pi
dl
sr313
t52
t35*
t32
Pi
dl
sr313
Pi
Pi
F-
P •
106-84-3     Oxiraneoctanoic acid, 3-octyl-, octyl ester
106-87-6     7-Oxabieyclo[4.1.0]heptane, 3-oxiranyl-
106-88-7     Oxirane, ethyl-
106-89-8     Oxirane, chloromethyl-
              aka:  Epichlorohydrin
                             20
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                           LISTED BY CAS NUMBER
           NAMES
CAS NUMBER
106-90-1
106-91-2
106-92-3
106-93-4
106-99-0
107-02-8
107-04-0
107-05-1
107-06-2
107-10-8
107-12-0
107-13-1
CHEMICAL NAME
2-Propenoie acid, oxiranylmethyl ester
2-Propenoie acid, 2 -methyl-, oxiranylnethyl ester
Oxirane , [ ( 2-propenyloxy ) methyl ] -
1 , 2-Dibromoethane
aka: Ethylene dibromide
1,3 -Butadiene
Acrolein
Ethane, l-chloro-2-bromo-
aka: CBB
Allyl chloride
Ethane , 1 , 2-dichloro-
aka: Ethylene dichloride
1-Propanamine
Propanenitrile
Acrylonitrile
RULE CODE
Pi
dl
Pi
dl
Pi
dl
srllO
sr313
f3
sr313
srllO
sr313
346
sr313
srllO
d20
sr313
t35*
die
t35*
srllO
sr313
107-18-6     2-Propen-l-ol
              aka:  Allyl alcohol

107-19-7     2-Propyn-l-ol

107-21-1     Ethylene glycol
107-30-2     Chloromethyl methyl ether
              aka:  Methane, chloromethoxy-

107-98-2     2-Propanol, 1-methoxy-
                 sr313**
                d!6

                srllO
                sr313

                sr3l3
                 P2l
                             21
(06/30/90)
-------
           CHEMICAL, ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
c
T.
JMBER   CHEMICAL NAME
RULE CODE
J-4     Acetic acid, ethenyl ester
        aka:  Vinyl acetate
108-10-1     2-Pentanone, 4-methyl-
              aka:  Methyl isobutyl ketone
108-31-6     2,5-Furandione
              aka:  Maleic anhydride
108-38-3     Benzene, 1,3-diaethyl-
              aka:  m-Xylene
108-39-4     Phenol, 3-methy1-
              aka:  n-Cresol
108-42-9     Benzenamine, 3-chloro-
1    5-2     1,3-Benzenediamine
              aka:  m-Phenylenedianine
                    m-Diaminobenzene
                    m-PDA

108-60-1     Propane, 2,2'-oxybis[l-chloro-
              aka:  Bis(2-chloro-l-methylethyl) ether
                    Bis(2-chloroisopropy1) ether

108-67-8     Benzene, 1,3,5-trimethyl-
108-70-3     Benzene, 1,3,5-trichloro-


108-71-4     1,3-Benzenediamine, 5-methyl-
              aka:  3,5-Diaminotoluene

108-78-1     Melamine

108-86-1     Benzene, bromo-

108-88-3     Benzene, methyl-
              aka:  Toluene
   srllO
   d!5
   sr313

   srllO
   Pi
   dl
   sr313

   t3S*
   Pi
   d6
                                                               Pi
                                                               dl
                                                               sr313

                                                               Pi
                                                               dl
                                                               sr313

                                                               Pi
                                                               dl

                                                               t36
                                                               Pi
                                                               d3
                                                               t52

                                                               t35
                                                               d20
                                                               sr313

                                                               d5
                                                               P7
                                                               t54

                                                               Pi
                                                               dl

                                                               P3
                                                               d3

                                                               sr3l3*

                                                               d20
                             22
                                              (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS  «  CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER

108-89-4
108-90-7



106-94-1
108-95-2


108-98-5
108-99-6
109-06-8
109-16-0
109-66-0
109-77-3

109-86-4
109-87-5
109-89-7
109-99-9
110-54-3


CHEMICAL NAME

Pyridine, 4 -methyl-
Benzene , 1,2,3-trichloro-
aJca : 1,2, 3-Trichlorobenzene



Cyclohexanone
Phenol


Benzenethiol
Pyridine, 3 -methyl -
Pyridine, 2-methyl-
aJca: 2-Picoline
2-Propenoic acid, 2 -methyl-, 1 , 2-ethanediy Ibis
( oxy-2 , 1-ethanediyL) ester
n-Pentane
Propanedinitrile
aka: Malononitrile

2 -Methoxy ethanol
Methane, dioethoxy-
Ethananine, N-ethyl-
aJca: Diethylanine
Tetr ahydr o f uran
Hexane


RULE CODE
dl
sr313
d6
srllO
Pi
dl
tio
sr313
tso
srllO
Pi
dl
srllO
d20
sr313
d!6
d6
t35**
d6
Pi
srllO
t35
die
tso
sr313
d20
d20
sr313**
srllO
srllO
tso
t52
110-75-8     Ethene, (2-chloroethoxy)                                srlio


                             23                     (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
C; FMBER

110-80-5
110-82-7

110-86-1

111-21-7
111-40-0

111-42-2

i: 1-4
111-54-4
111-65-9
111-69-3
111-76-2
111-77-3
111-90-0
111-91-1

CHEMICAL NAME
aka: 2-Chloroethyl vinyl ether
2 -Ethoxyethanol
Cyclohexane

Pyridine

Ethanol, 2,2'-[l,2-
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
112-34-5
112-35-6
112-50-5
112-90-3
114-26-1
114-49-8
115-07-1
115-27-5
115-28-6
115-29-7
115-32-2
115-86-6
CHEMICAL NAME RULE CODE
Diethylene glycol butyl ether
Ethanol, 2-[2-(2-methoxyethoxy)ethoxy]-
aka: Triethylene glycol aononethyl ether
Ethanol, 2-[2-(2-ethoxyethoxy)ethoxy]-»
aka: Triethylene glycol monoethyl ether
9-Octadecen-l-anine , ( Z ) -
aka : Oleylamine
ODA
Propoxur
Benzeneacetie acid, alpha- (hydroxymethyl)-, 9 -methyl
-3-oxa-9-azatricyclo[3.3.1.0 (2,4) ] non-7 -yl ester,
hydrobromide, [7 (S) - ( lalpha , 2beta , 4 bet a , Salpha ,
7beta) ]
Propylene
aka: Propene
4 , 7-Methanoisobenzof uran-1 , 3-dione , 4,5,6,7,8,8-
hexachloro-3a ,4,7, 7a-tetrahydro-
aka: Chlorendic anhydride
Bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid, 1,4,
5,6,7, 7-hexachloro-
aka: Chlorendic acid
Endosulfan
aka: Alpha, beta, sulfate
Dicofol
Phosphoric acid, triphenyl ester
t!9
tso.
t34
P12
d!2
t34
pl2
d!2
t29
PS
d7
t52
sr313
Pi
sr313
cl
Pi
cl
Pi
d3
rl
srllO
sr3l3
Pi
dl
115-96-8     Ethanol, 2-chloro-, phosphate  (3:1)
              aka:  Tris(2-chloroethyl) phosphate
                                                                    ml
116-14-3
             Ethene, tetrafluoro-
t:
                             25
                                                    (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                           LISTED BY CAS NUMBER
                                                  NAMES
C3 MBER
116-15-4


117-79-3
117-81-7

117-84-0

118-74-1

1JH--7S-2
1] 1-6


118-96-7
119-06-2
119-07-3
19-90-4
119-93-7
120-12-7


CHEMICAL NAME



2 -Aainoanthraquinone
1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl)
ester
aka: Bis(2-ethylhexyl) phthalate
Di (ethylhexyl) phthalate
DEHP
1,2-Benzenedicarboxylic acid, dioctyl ester
aka: Di-n-octyl phthalate

Hexaehlorobenzene

2,3,5, 6-Tetrachloro-2 , 5-cyclohexadiene-l , 4-dione
Phenol , 2,4, 6-tribromo-


2,4, 6-Trinitrotoluene
1,2-Benzenedicarboxylic acid, ditridecyl ester
aka: Ditridecyl phthalate
1,2-Benzenedicarboxylic acid, decyl octyl ester
3,3' -Diaathoxybenzidine
3,3' -Dimethylbenzidine
aka : o-Tol idine
Anthracene


RULE CODE
d3
t52
t23
Pi
d3
t52
sr313
t44
srllO*
Pi
dl
sr313
srllO
Pi
dl
sr313
srllO
sr313
t31
t31
Pi
d27
p23
srllO
t44
Pi
dl
Pi
dl
sr3l3
sr3: J
sr '.
d2
sr
120-32-1
Phenol, 4-chloro-2-chlorophenol(phenylmethyl)-
                             26
                                       (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
CAS NUMBER

120-36-5
120-58-1

120-71-8
120-80-9
120-82-1





120-83-2


121-14-2

121-39-1

121-44-8
121-45-9
121-47-1

121-69-7
121-75-5
121-82-4

121-87-9

122-07-6
122-09-8

CHEMICAL NAME
aJca; 2-Benzyl-4-chlorophenol
2-2, 4-(Dichlorophenoxy)propionic acid
1,3-Benzodioxole, S-(l-propcnyl)-
aka: Isosafrole
p-Crcsidine
cate^Jiol
Benzene, 1,2,4-trichloro-





2 , 4-Dichlorophenol


2 , 4-Dinitrotoluene

Oxiranecsrboxylic acid, 3-phenyl-, ethyl ester

Ethanamine, N,N-diethyl-
Phosphorous acid, triaethyl ester
Benzenesulfonic acid, 3-amino-

N , N-Dimethy laniline
Nalathion
Cyclonite
aka: RDX
Benzenamine , 2-chloro-4-nitro-

Ethanaoine , 2 , 2-dimethoxy-N-methyl-
Benzeneethananine, alpha, alpha-diaethyl-
aka: alpha, alpha-DinethvlDhenethvlaaine
RULE CODE
d25
t31
sr3l3**
t35*
sr313
sr3l3
srlio
Pi
dl
ta
tio
sr313
t31
srllO
sr313
srllO
SF313
Pi
dl
d20
Pi
r2
d20
sr313
srllO
srllO

Pi
dl
Pi
t35*
d!6
                  27
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES. (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
Ct MBER
12 -1
122-66-7
122-99-6
123-31-9
123-33-1
123-38-6
123-54-6
123-61-5
123-63-7
i: -a
123-91-1
124-16-3
124-17-4
124-48-1
124-73-2
126-71-6
126-72-7
CHEMICAL NAME
Oxirane , (phenoxymethyl ) -
Hydrazine, 1,2-diphenyl-
aka: Hydrazobenzene
Ethanol , 2-phenoxy-
1,4-Fenzenediol
aka: Hydroquinone
Maleie hydrazide
Propionaldehyda
2 , 4-Pentanedione
Benzene , 1,3 -diisocyanato-
Paraldehyde
Butyraldehyde
aka: Butanal
1,4-Dioxane
2 -Propanol , 1- ( 2 -butoxyethoxy ) -
aka : l-Butoxyethoxy-2 -propanol
Ethanol, 2-(2-butoxyethoxy)-, acetate
aka: Diethylene glycol butyl ether acetate
2 - ( 2 -Butoxyethoxy ) ethyl acetate
Methane, dibronochloro-
aka: Chlorodibroaomethane
Oibromotetrafluoroethane
aka: Halon 2402
Phosphoric acid, tris(2-methylpropyl) ester
Tris (2,3 -dibronopropyl ) phosphate
RULE CODE
pi
dl
srllO
d20
sr313
p4
d4
d!9
Pi
t7
sr313
t35
sr313
S54
c2
d20
t35*
p20
d24
sr313
srllO
sr313
P21
d25
t!9
P5
d7
srllO
d20
sr313#
C2
a2
S6
                  28
(06/30/90)
-------
            CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS  &  CHEMICAL
                            LISTED  BY CAS NUMBER
            NAMES
CAS  NUMBER   CHEMICAL NAME
              RULE CODE
126-73-8      Phosphoric acid,  tributyl ester
               aka:  Tributyl phosphate
126-80-7      Disiloxane,  l,l,3,3-tetramethyl-l,3-bis[3-
               oxiranylmethoxy)propyl]-

125-98-7      Methacrylonitrile

125-ss-a      1,3-Butadiene,  2-chlorc-
               alca:  Chloroprene
127-18-4      Ethene, tetrachloro-
               aJca:  Perchloroethylene
                    Tetrachloroethylene

128-39-2      Phenol, 2,6-bis(l,l-dinethylethyl)-
               aka:  2,6-Di-tert-butyl phenol
                    DTBP

128-66-5      C.I. Vat Yellow 4

128-86-9      2,6-Anthracenedisulfonic acid, 4,8-diaraino-9,10-
               dihydro-l,5-dihydroxy-9,10-dioxo-

129-00-0      Pyrene
               aka:  Benzo[def]phenanthrene
                 sr313

                 c2
                 t39
                 pl4
                 dl8

                 dl
                 t35*

                 Pi
                 P9
                 dlO
                 sr313

                 srllO
                 d20
                 sr313

                 t38
                 P13
                 dl4

                 sr313

                 pl7
                 al
                 sr
131-11-3     1,2-Benzenedicarboxylic acid, dimethyl  ester
              aka:  Dimethyl phthalate
131-15-7     1,2-Benzenedicarboxylic acid, bis(l-methylheptyl)
              ester

131-17-9     1,2-Benzenedicarboxylic acid, di-2-propenyl ester
              aka:  Diallyl phthalate

131-89-5     4,6-Dinitro-o-cyclohexylphenol

132-64-9     Dibenzofuran
                              29
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CJ MBER
133-06-2
133-90-4
134-29-2
134-32-7
135-20-6
135-98-8
137-09-7
137-20-2
137-26-8
139-13-9
i: 1-3
139-65-1
140-08-9
140-30-4
140-57-8
140-66-9
CHEMICAL NAME
Captan
Chloraaben
o-Anisidine hydrochloride
alpha-Naphthylamine
aJca: 1-Naphthylaaine
Cupferron
Benzene , ( 1-aethy Ipropy 1 ) -
Phenol, 2,4-diaaino-, dihydrochloride
E thanesul f onic acid , 2 - [ methyl ( l-oxo-9-octadeceny 1 )
aaino]-, sodiua salt, (2)-
aka: N-Methyl-N-oleoyltaurine, sodiua salt
Thioperoxydicarbonic diaaide, tetraaethyl-
Nitrilotriacetic acid
Benzene , 1,1' -methylenebis [ 4-isocyanato-T-methyl-
4,4' -Thiodianiline
Tris ( 2-chloroethy 1 ) phosphite
2-Mereaptobenzothiazole
Araaite
Phenol, 4-(l, 1, 3 , 3-tetramethylbutyl) -
RULE CODE
sr313
sr313
sr313
sr313
t35*
sr313
sr313
d20
P3
d3
dlO
d20
sr3l3
C2
d20
sr313
P'-
d3
» *
-.:-.
•_-

140-88-5     2-Propenoic acid, ethyl ester
              aka:  Ethyl aerylate
141-32-2     2-Propenoic acid, butyl ester
                             30                     (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES  (CAS)  NUMBERS  &  CHEMICAL NAMES
                LISTED BY.CAS NUMBER
CAS NUMBER CHEMICAL NAME RULE CODE
141-38-8
141-79-7
141-85-5
142-04-1
142-09-6
142-28-9
142-82-5
142-84-7
142-90-5
143-22-6
145-73-3
147-14-8
147-82-0
149-30-4

149-57-5

oxiraneoctanoic acid, 3-octyi-, 2-ethylhexyl ester
3-Penten-2-one, 4-nethyl-
aJca: Mesityl oxide
Benzenaaine, 3-chloro-, hydrochloride
Benzenamine, hydrochloride
2-Propenoic acid, 2-aethyl-, hexyl ester
Propane , 1,3 -dichloro-
Heptane
1-Propanaaine, N-propyl-
2-Propenoic acid, 2-aethyl-, dodecyl ester
Ethanol, 2-[2-(2-butoxyethoxy)ethoxy]-
axa: Triethylene glycol monobutyl ether
7-Oxabicyclo[2.2.1]heptane-2,3-dicarboxylic acid
Copper, [29H,31H-phthalocyaninato(2-)-N (29), N (30),
N (31), N (32)]-, (SP-4-1)-
afca: C.I. Pignent Blue 15
Benzenaaine, 2 , 4 , 6-tr ibromo-
2 (3H) -Benzothiazolethione
aka: Mercaptobenzothiazole

Hexanoic acid, 2 -ethyl -

Pi
P8
dl
t6
Pi
dl
Pi
Pi
p21
die
sriio
d!6
Pi
t34
P12
d!2
Pi
sr3l3*
Pi
dl
t25
P9
dlO
tso
P6
d8
t!3
151-56-4     Ethyleneiaine
              aka:  Aziridine

155-41-9     3-oxa-9-azoniatricyclo[3.3.1.0 (2,4) Jnonane, 7-(3-
              hydroxy-l-oxo-2-phenylpropoxy) -9 , 9-diaethyl-,
              bromide, [7(S)-(lalpha,2beta,4beta,5alpha,7beta) ]
                                                         pi
                  31
                                                   (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                           LISTED BY CAS NUMBER
                                                  HAKES
NUMBER
136-10-5
156-59-2
156-60-6
156-62-7
191-24-2
193-39-5
205-99-2
2Q6-44-0
207-08-9
208-96-8
218-01-9
285-67-6
-20-4
298-04-4
302-01-2
306-83-2
309-00-2
319-84-6
320-72-9
328-84-7
CHEMICAL NAME
p-Nitrosodiphenylanine
cis-1, 2-Dichloroethylene
Ethene, 1,2-dichloro-, (E)-
aJca : 1,2 -trans-Dichloroethene
Calcium cyanaaide
Benzo [g,h, i]perylene
Indeno [1,2,3 -cd ] pyrene
Benzo [ b ] f luoranthene
Fluoranthene
Benzo (k) fluoranthene
Acenaphthylena
Chrysene
6-Oxabieyelo [3.1.0] hexane
7-oxabicyclo [4.1.0] heptane
Oisulfoton
Hydrazine
Ethane , 2 , 2-dichloro-l , 1 , 1-trif luoro-
aka : 2 , 2-Dichloro-l , 1 , 1-trif luoroethane
HCFC-123
Aldrin
Cyclohexane, 1,2,3,4,5,6-hexachloro-, (lalpha,
2 alpha, 3 bet a , Aalpha , Sbeta , 6beta ) -
3,5-Dichlorosalieyclic acid
Benzene, 1, 2-dichloro-4- (trif luoronethyl) -
aka: 3 , 4-Dichlorobenzotrif luoride
DCBTF
RULE CODE
sr313
srllO
srlio
sr3l3
srlic
srlio
srllO
srllO
srllO
srllO
srllO
Pi
Pi
srlio
srlir
sr31.
d28
sr313
srllO
t31
t37
plO
d9
tso
334-88-3
Diazoðane
sr::3
                             32
                                       (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
CAS NUMBER
353-50-4
354-33-6
357-57-3
359-11-5
421-01-2
428-59-1
463-58-1
470-67-7
472-41-3
479-45-8
488-47-1
492-80-8
494-03-1
496-72-0
505-60-2
506-68-3
506-96-7
510-15-6
512-56-1
CHEMICAL NAME
Carbonyl fluoride
Ethane, pentafluoro-
aka: Pentafluoroethane
HFC- 12 5
Strychnidin-10-one, 2 , 3-dinethoxy-
Ethene, trifluoro-
Bromochlorodifluoromethane
aka: Halon 1211
Oxirane , trif luoro ( trif luoromethyl ) -
aka: Hexafluoropropylene oxide
HFPO
Carbonyl sulfide
7-Oxabicyclo [2.2.1] heptane , l-nethyl-4-
(1-methylethyl)-
Phenol , 4- ( 3 , 4-dihydro-2 , 2 , 4 -trine thy 1
-2H-l-benzopyran-4-yl) -
Trinitrophenylmethylnitramine
Tetrabronocatechol
Auraaine
Chlornaphazine
1,2-Benzenediamine, 4 -me thy 1-
aka : 1 , 2-Dianino-4-nethylbenzene
Mustard gas
aka: Ethane, l,l/-thiobis[2-chloro-
Cyanogen bromide
Acetyl bromide
Chlorobenz il ate
Phosphoric acid, t rime thy 1 ester
RULE CODE
t35*
d28
d!6
P3
d3
rl
sr313f
t24
a9
dl
s9
sr313
Pi
r2
d20
srllO
t31
sr313
t35*
Pi
d3
srllO
sr313
t35*
d20
sr313
c2
                  33
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES*(CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CA IBER
1
52_ . _ -8
528-29-0
530-50-7
532-27-4
534-07-6
534-15-6
534-52-1
540-54-5
540-59-0
540-84-1
54 -3
54 -5
541-70-8
541-73-1
542-75-6
542-76-7
542-88-1
CHEMICAL NAME
Benzene,. 1,2,3-triaethyl-
Benzene , 1 , 2-dinitro-
aka: o-Dinitrobenzene
Hydrazine, 1 , 1-diphenyl-
2 -Chloroacetophenone
2 -Propanone „ 1,3 -dichl oro-
E thane, 1,1-diBethoxy
4 , 6-Dinitro-o-cresol
aka : 4 , 6-Dinitro-2-methylphenol
Propane, 1-chloro-
1 , 2-Oiehloroethylene
Pentane , 2,2,4 -triaethy 1-
Ethyl ehloroformate
1 , 3 -Benzenediaaine , dihydrochlorida
aka: a-Phenylenediammoniua dichloride
1,3 -Benzenediaaine, sulfate (1:1)
aka: m-Phenylenediaaine, sulfate salt
a-PDA. (H)2 S(O)4
Benzene, 1,3-dichloro-
1-Propene, 1,3-dichloro-
aka: 1,3-Oichloropropylene
Propanenitrile, 3-chloro-
Bis ( chloroaethy 1 ) ether
RULE CODE
d5
P7
sr313**
d20
sr313
d20
Pi
srlio
sr313
d20
srlio
sr313
d20
sr313
P3
d3
t36
P3
d3
t52
srllO
t35**
Pi
dl
sr313
d20
sr313
t35*
srllO
sr313
554-00-7
Benzenaaine, 2,4-dichloro-
                             34
                                       (06/30/90)
-------
 Chapter Ten	Post-Inspection Activities

                            10.0 POST-INSPECTION ACTIVITIES

 10.1  INTRODUCTION
 The effectiveness of a TSCA compliance  inspection is dependent on  many  factors,  including the
 thoroughness of the inspection, the evidence collected by the inspector, and the cooperation of the facility
 being inspected.  Critical to the success of the inspection process are two steps that follow the inspection
 itself:

    • Conducting necessary foliowup activities (discussed in  Section 10.2) at the conclusion of the
      inspection
    • Preparing the inspection report (discussed in Section 10.3).

 The guidance that follows includes discussion of followup activities and  report preparation,  including
 guidance on what to do with the inspection report once it is completed. Followup activities are necessary
 to ensure that any outstanding data pertaining to the facility and the inspection are obtained as soon as
 possible following the inspection for inclusion in the  inspection report.  The primary function of the
 inspection report is to serve as the main document upon which EPA Case Development Officers (CDOs)
 will base enforcement decisions concerning the facility.  Each of these two steps is discussed below.

 10.2  FOLLOWUP
 Prior to preparing  the.inspection report, the inspector should gather  all  data collected during the
 inspection, including documents and other supporting evidence obtained before and during the inspection,
such as photographs, inspection  report forms, any inspection checklist used, and the  field logbook or
other inspection notes (if used).  The inspector should review the information, noting any gaps or
discrepancies, and refresh her/his memory of the entire inspection process.  Gaps may  need to be filled
 in by a phone call or, in unusual circumstances, a followup visit.  Written requests may also be utilized
to collect additional information.  Such requests should always specify a timeframe for a response (usually
 30 days).

The inspector should conduct the necessary followup to answer outstanding questions and obtain relevant
documents.  The  inspector should focus on  obtaining  information necessary to fill in  gaps in material
 already obtained from EPA records and/or the facility pertaining  to facility operations and compliance


 TSCA §§ 5/8 Inspection Guidance             10-1                                November 1992
-------
Post-Inspection Activities	Chapter Ten

with TSCA. The inspector should also collect information that clarifies the data already in the inspector's
possession.  This additional and clarifying information should be included in the inspection report (see
Section 10.3.3).

In order to obtain such information, the inspector should contact the facility representative by telephone
and/or by letter and request that outstanding data be submitted. The inspector should keep in mind that
s/he may have already requested the  facility to provide  additional or clarifying data at the closing
conference (see Section 4.9). Therefore, the purpose of conducting followup activities is to ensure that
facility representatives followup on requests by EPA to supply missing data concerning the inspection.
Other followup can be through Headquarters  (late reports, etc.), other contacts suggested on site, or other
program offices, if warranted.  For example, the inspector may need  to search the confidential TSCA
Inventory; this search would be performed by the Information Management Division OMD) of the Office
of Pollution Prevention and Toxics (OPPT).

10 J  THE INSPECTION REPORT
The following guidance  on preparing  the inspection report includes objectives of the report (Section
10.3.1), CBI considerations (Section 10.3.2), and report elements (Section 10.3.3).

The inspector should prepare the inspection report as soon as possible following the  inspection.  EPA
recommends that the report be completed within 45 days of the inspection; however, the actual amount
of time will depend on obtaining any additional required information in  a timely fashion. This timeframe
should allow the inspector sufficient time to conduct necessary followup and to append to the report (and
mention in the narrative) any data obtained during followup.

The purpose of the inspection report is  to present a complete and factual record of the inspection process
from opening conference, to the inspection  itself, to closing conference.  The inspector should keep in
mind that the report should contain enough information about the facility and the inspection (as well as
observations made during the inspection) to enable  CDOs to make enforcement decisions pertaining to
the subject facility and to develop a case, as necessary.
November 1992                               10-2            TSCA §5 5/8 Inspection Guidance
-------
 Chapter Ten	Post-Inspection Activities

 IOJ.1   OBJECTIVES
 As the inspector prepares the report, s/he should have the following objectives in mind:

   • To include in the report all of its basic elements (see Section 10.3.3), ensuring that the report not
      only  contains copies of relevant forms and  documents as appendices,  but  that the narrative
      component of the report references those forms and documents
   • To substantiate with as much evidence as possible each potential-violation of TSCA cited in the
      report, ensuring that any documents  and/or photographs are not only appended to the report, but
      are referenced in the narrative component of the report.  (This is necessary so that CDOs know
      how the data relates to the inspection.)
   • To write the report in clear and concise language
   • To present factual and accurate information pertaining to all steps in the inspection process from
      opening to closing conference and foliowup
   • To make only those observations that are based  on  firsthand knowledge of the facility since
      enforcement personnel must be able to depend on the accuracy of all information
   • To include only information that is relevant  to  the facility  and its compliance with TSCA.
      (Irrelevant facts can interfere with enforcement decisionmaking.)

 IOJ.2   CONFIDENTIAL BUSINESS INFORMATION CONSIDERATIONS
 While preparing the inspection report, the inspector  should keep in  mind that some or all of the data
 gathered during the inspection may be confidential business information (CBI),  if properly claimed as
 such by the facility.  Otherwise, the report may be released to the public  in response to a Freedom of
 Information Act  (FOIA) Request,  unless the  report falls under a FOIA exemption, such  as  law
 enforcement. Therefore, if the inspection report contains CBI, those portions of the inspection report
 must be treated in accordance with  TSCA CBI procedures.  However, the inspector may refer to CBI
 material in general terms (e.g., by a reference number assigned by the inspector) so that the report need
 not be treated as CBI.  Additional information concerning the handling of CBI can be found in the TSCA
Business Information Security Manual.

 10 JJ   ELEMENTS OF THE INSPECTION REPORT
 While inspection reports may vary in general content and format, there are certain elements that should
 be contained in each inspection report in order to ensure that necessary information is not inadvertently
 overlooked. The  basic components of the  inspection  report are discussed below.
TSCA §§ 5/8 Inspection Guidance            10-3                               November 1992
-------
Post-Inspection Activities	Chapter Ten

The inspection report should be a concise and chronological account of observations made and activities
undertaken during the  inspection, from opening conference to closing conference and followup.  The
inspector may find that the field logbook and/or an inspection checklist (if either were used) are useful
tools for developing the narrative.  These tools can help the inspector recall and include in the narrative
important details concerning the inspection.  The  inspector should  also include the reason for the
inspection and any relevant historical information, such a& Dun and Bradstreet (D&B) reports and any
knowledge of prior violations obtained during the pre-inspection process.  If the company learned  of
anything as a result of the inspection that it might decide to submit to EPA,  it would be helpful if the
company also sent copies of these documents tu the inspector for inclusion in the inspection report.

Perhaps the most important guide to  the inspector for  writing the inspection  report is  the outline
(discussed below) that  the inspector should prepare prior  to writing the narrative. The purpose of the
outline is to serve as a blueprint for the development of the inspection report.

A well-developed outline will ensure that the inspector includes in the narrative all information pertinent
to the inspection, and, ultimately, the  outline can serve  to support subsequent enforcement decisions
relating to the facility.  The inspector should keep in mind that the suggested outline may be modified
based upon the particular circumstances of a given inspection.

    •  Title Page
    • Index
    • Facility Information
     The facility information should include:
         Company name,  address, and telephone number
     -   Primary SIC code
     -   DUNS number
         Corporate  fiscal year
         Number of employees
         Approximate sales  (year)
November 1992                               10-4            TSCA §§ 5/8 Inspection Guidance
-------
Chapter Ten	Post-Inspection Activities


          Type of facility

          Parent company name and address

          Parent company approximate sales (year)

          Primary areas of business

    o Inspection Conduct Information

      Information under this heading should include:

          Date of notification

      -    Type of inspection conducted

          Date and time of inspection

          Responsible official's name, title, and telephone number

          Name of EPA inspector

          Other facility participants

    • Inspection results

      This section should provide a brief summary of the inspection results and the factors that led to the
      inspector's conclusions.  A sample of the Inspection Results section of a report is shown in Figure
      10-1.

    • TSCA administrative exhibits

      The inspector  should attach, as exhibits  to  the  inspection report,  all documentary evidence,
      including photographs, that supports the observations made during the inspection (and which should
      be described in the report narrative, as appropriate).  The inspector should be sure that any data
      attached to the report as an exhibit is labeled as such and is mentioned within the narrative.  Also,
      the inspector should prepare an index of exhibits (or attachments) listing the name and the location
      of each exhibit.  This index should precede the exhibits and serve as a reference for enforcement
      personnel.

      There are numerous  forms pertaining to the inspection that  should  be labeled as exhibits  and
      appended to the end of the inspection report.  The most important exhibits are the forms and the
      notification letter relating to the TSCA inspection.  They should be  labeled and attached to the
      report as follows:

      -    Exhibit 1:  Notification Letter (see Figure 3-4)

      -    Exhibit 2:  Notice of Inspection (see Figure 4-1)
TSCA §§ 5/8 Inspection Guidance             10-5                               November 1992
-------
Post-Inspection Activities                    	                         Chapter Ten
                                        FIGURE 10-1

               INSPECTION RESULTS SECTION OF REPORT - EXAMPLE 1

     m.   INSPECTION RESULTS

           A.  TSCA Section 5 Findings

               1.  General Inventory

                   The   inspector  determined,   through  a   comprehensive  review   of
                   [Company/Facility  NameJ's records (19	  to  19	),  that  all  chemicals
                   commercially  manufactured by  the  facility and  all chemicals used  us  raw
                   materials by the facility appear on the TSCA Section 8(b) Chemical Substance
                   Inventory (TSCA Inventory).  Additionally, R&D activities, as defined under
                   TSCA, are conducted at the facility and were found to be consistent with 40
                   CFR 720.

               2.  Premanufacture Notification Review

                   No PMNs have been submitted since 1987.

           B.  TSCA Section 8 Findings

               1.  Partial Inventory Update Rule

                   A review of  available Agency and  corporate records  did  not reveal  any
                   noncompliance with regard to 40 CFR §710.33(a).


               2.  Section 8(a) Level A and 8(d)

                   The inspector  verified that [Company/Facility  Name] had not manufactured or
                   imported chemicals  for which a manufacturer's PAIR or a Section 8(d) report
                   was required.


               3.  Section 8fc) and %(e)

                   Verification was made that allegations have not been received indicating adverse
                   effects upon human health or the environment.  [Company/Facility Name] stated
                   it had not received nor was it aware of information that would have required
                   submission of a Notice of Substantial Risk. A  review of [Company/Facility
                   Name] records seemed to confirm this statement.
November 1992                              10-6            TSCA §§ 5/8 Inspection Guidance
-------
Chapter Ten 	           	                              Post-Inspection Activities
                                      FIGURE 10-2

              INSPECTION RESULTS SECTION OF REPORT - EXAMPLE 2

         INSPECTION RESULTS

         A. TSCA Section 5 Findings

            1.  General Inventory

                During the inspection, the inspector determined that [Company/Facility Name]
                manufactured for commercial purposes, a chemical substance that is not tbund on
                the Section 8(b) Chemical Substance Inventory (TSCA Inventory). The chemical
                substance  identified  as  [Company/Facility  NameJ's product code XXX was
                manufactured between [Date] and [Date].

                Manufacture of product XXX  occurred on XX  separate dates  totaling 20
                commercial batches and amounting to approximately 140,000 pounds as finished
                product.

                The commercial manufacture of product XXX is inconsistent with the regulations
                for new chemical  manufacture found  in 40 CFR Section 720.22.

            2.  Premanufacture Notification Review

                During the inspection, the inspector reviewed one chemical substance that was the
                subject of a PMN  submitted by [Company/Facility Name].  The inspector verified
                the PMN's number to be XXX  and that the manufacture was commenced at
                [Facility Name].

                The chemical substance described in XXX has the chemical name [Insert name].

                PMN XXX was submitted to the Agency on [Date].  The end of the 90-day review
                period was determined  to be [Date].  The inspector verified that  the first
                commercial production batch was manufactured on [Date].  The NOC was mailed
                to the Agency on [Date] within the 30 days allowed under the regulations found
                in 40 CFR Section 720.(b)(l).
TSCA §5 5/8 Inspection Guidance            10-7                             November 1992
-------
Post-Inspection Activities                                                        Chapter Ten
                                        FIGURE 10-2

               SAMPLE OF INSPECTION RESULTS SECTION OF REPORT -
                                EXAMPLE 2 (CONTINUED)

        B.    TSCA Section 8 Findings

          1.  Partial Inventory Update Rule

              During the inspection  and  follow-up investigation, the inspector determined  that
              [Company/Facility Name] incorrectly used calendar year production volumes rather
              than corporate fiscal year production volumes in reporting to the IUR.  This error
              resulted   in  incorrect  production volumes  being  reported  to  the  IUR  for
              [Company/Facility Name].


          2.  Section 8fa) Level A and 8fd)

              The inspector  verified that [Company/Facility  Name]  had not manufactured or
              imported  chemicals for which a manufacturer's PAIR or a Section 8(d) report  was
              required.


          3.  Section 8(c) and 8fe)

              Verification was made that allegations have not been received indicating adverse
              effects upon human health or the environment.  [Company/Facility Name] stated it
              had not received nor was it aware of information that would have required submission
              of a Notice of Substantial Risk.   A review of  [Company/Facility Name] records
              seemed to confirm this  statement.
November 1992                              10-8            TSCA §§ 5/8 Inspection Guidance
-------
Chapter Ten	"	Post-Inspection Activities


      -   Exhibit 3:  TSCA Inspection Confidentiality Notice (see Figure 4-2)
         Exhibit 4:  Receipt for Samples and Documents (see Figure 4-4)
      -   Exhibit 5:  Declaration of Confidential Business Information (see Figure 4-3).

      In addition to the above forms, the inspector should attach to the report any inspection checklist
      used during the inspection. The inspector should keep in mind that not every Region has developed
      a  checklist for use during the inspection process, but that if one was developed and used, it should
      be attached to die report and may serve as the basis upon which the narrative language of the report
      is developed.

Once the outline has been prepared, the inspector should write the narrative using the outline as a guide.
The inspector should follow the tips in Figure 10-3 when writing the inspection report.

103.4   INSPECTION SUMMARY
The inspection summary  is not an actual component of the inspection report, but  rather a stand-alone
document that can be produced in conjunction with the inspection report. The inspection summary should
include  the type of inspection conducted,  specific  inspection priorities, and any potential violations
identified by the inspector.  The potential violations are noted separately from the  inspection report
because they are pre-decisional  [e.g., opinion(s) of an inspector prior to an actual enforcement decision].
Pre-decisional notes of violations are exempted from release pursuant to a request under FOIA.  The
actual report may be releasable, unless other exemptions under FOIA apply (such as CBI claims).

10.4  WHAT TO DO WITH COMPLETED INSPECTION REPORT
The inspection report is filed, reviewed by the TSCA coordinator or supervisor, and sent to the CDO.
The CDO will draft a complaint if a violation exists.  Most Regions also need  concurrence by the Office
of Compliance Monitoring (OCM) before case issuance.  Initial case review, determination of possible
violation, and case development will be conducted by the Regions. The developed case will be submitted
to the appropriate  Headquarters compliance officer per  OCM concurrence  policy until relaxation is
granted.
November 1992                              10-9            TSCA §§ 5/8 Inspection Guidance
-------
Post-Inspection Activities	Chapter Ten
                                        FIGURE 10-3

                    TIPS FOR DEVELOPING NARRATIVE LANGUAGE

   When developing the narrative language portion of an inspection report, the inspector should:

      • Write the narrative in accordance with the report outline

      • Ensure that the reader is  able to readily  ascertain the following information from the
        narrative:

            The specific reason for the inspection

            Who  participated in the inspection  (i.e., identity of each facility representative and
            inspector)

            A  brief  description of the facility being inspected (i.e., what it imports and/or
            manufactures, physical size of plant, number of buildings, etc.)

        -   That all required notices and receipts were completed and issued as required and are
            attached to the report

        -   The actions taken during the inspection, in chronological order

            What observations were made during the inspection

            What evidence (e.g., documents, photographs) was collected during the inspection. The
            inspector should identify the evidence within the narrative and include copies of such
            evidence as exhibits. The inspector should be very careful not to draw conclusions as
            to  the existence  of any actual violations of TSCA, as this is the responsibility of the
            CDOs. However, if the inspector decides to write a summary of the violations, it should
            be done on a sheet of paper separate from the rest of the report.

      • Include within the narrative the components of the suggested report format (see Section
        10.3.3) identified as appropriate for inclusion within the narrative (e.g., general information,
        summary  of findings, facility background, and  inspection activities).
November 1992                              10-10            TSCA §§ 5/8 Inspection Guidance
-------
-------
IfRiiOBAIfDUM

SUBJECT:  Updated Targeting Printouts

From:     Michael F. Wood, Director
          Compliance Division  (EN-342)

TO:       Linda A. Travers, Director
          Information Management Division (TS-793)

     The Office of Compliance Monitoring is requesting an update
of previously requested targeting data.  These updated printouts
will allow our inspectors to use current information when
selecting their targets.  Please note that the information OCM is
requesting is substantially the same as the information requested
in Enforcement Request (ER) Numbers 87-399, 88-011, 88-074, 89-
021, 89-138, and 90-104.

     Please provide these printouts to Phil Milton of my staff by
September 21, 1990.  Attached is a listing of the information for
which we need updates.  The information provided in response to
ER 90-104 did hot include Printout I or Plant Site Addresses.
Please ensure that this information is included with this ER
response or let us know as soon as possible if there is a problem
providing this information.  Thanks for your cooperation in this
effort.  If you have any questions, please call Phil Milton at
475-6732.

Attachment

cc:  Sherry Sterling (EN-342)
     Frank Caesar (TS-793)
     Steve Newburg-Rinn (TS-793)
-------
            CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL
                            LISTED BY CAS NUMBER
            NAMES
CAS NUMBER

556-52-5

556-67-2


558-30-5

563-04-2
563-41-7

563-54-2

563-58-6

569-64-2
•
573-58-0

580-51-8
583-78-8
584-84-9



591-08-2

591-78-6

593-60-2

CHEMICAL NAME

Oxiraneaethanol
aka: Glycidol
Cyclotetrasiloxane, octaaethyl-
aka: OMCTS

Oxirane, 2 , 2-diaethyl-

Phosphorie acid, tris(3-methylphcnyl) ester
Hydra zinecarboxamide monohydrochloride
aka: Seaicarbazide hydrochloride
1-Propene , 1 , 2-dichloro-

1-Propene , 1 , 1-dichloro-

C. I. Basic Green 4
1-Naphthalenesulf onic acid , 3 , 3 ' - [ [ 1 , 1 ' -biphenyl ]
-4,4'-diylbis(azo)]bis[4-aaino-, disodium salt
[1.1* -Biphenyl ] -3 -ol
2 , 5-Oichlorophenol
Benzene , 2 , 4-diisocyanato-l-methyl-
aka : Toluene-2 , 4-diisocyanate


Acetaaide, N-(aminothioxomethyl)-

Methyl n-butyl ketone
aka : 2 -Hexanone
Ethene, broao-

RULE CODE
dl
pi
dl
t28
P9
dlO
r2
dl
dl
ml

r2
die
r2
die
sr3£3
dl

d20
t31
ml
C2
d20
sr313
t35*
d!6
srllO
s7
Pi
sr; 13
594-20-7     Propane, 2,2-dichloro-

598-21-0     Acetyl bromide, broao-
                             35
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS)  NUMBERS & CHEMICAL NAMES
LISTED BY CAS NUMBER
( UMBER
1 1-2
603-35-0
606-20-2
608-27-5
(508-^1-9
608-93-5
611-14-3
614-94-8
( 15-4
615-28-1
615-45-2
615-46-3
615-50-9
615-58-7
616-23-9
CHEMICAL NAME
2 -Propanone , 1-broao-
aka: Bromoacetone
Phosphine, triphenyl-
2 , 6-Dinitrotoluene
Benzenamine, 2,3-dichloro-
Pentabronophenol
Benzene, pentachloro-
o-Ethyltoluene
aka: Benzene, l-ethyl-2-methyl-
1,3 -Benzenediamine, 4-methoxy-, dihydrochloride
aka : m-Phenylenediamine , 4 -methoxy- ,
dihydrochloride
1 , 3 -Benzenediamine , 4-nethoxy-
aka: m-Phenylenediaaine, 4-nethoxy-
1,2 -Benzenediamine dihydrochloride
aka: 1,2-Phenylenediamine dihydrochloride
1,4 -Benzenediamine, 2 -methyl-, dihydrochloride
1,4 -Benzenediamine, 2-chloro-, dihydrochloride
p-Phenylenediamine, 2-chloro-, dihydrochloride
1,4 -Benzenediamine, 2 -methyl-, sulfate (1:1)
aka: 2 , 5-Diaminotoluene sulfate
2 , 4-Dibromophenol
1-Propanol, 2,3-dichloro-
RULE CODE
t35*
d!6
Pi
srllO
t35**
sr313
Pi
dl
t31
srllO
t35
Pi
dl
r2
d3
r2
P3
d3
Pi
d3
sr313
P3
d3
P3
d3
r2
P3
d3
P3
d3
t31
t:
di-
620-14-4     Benzene, l-ethyl-3-methyl-
              aka:  m-Ethyltoluene
                             36
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED BY CAS NUMBER
            NAMES
CAS NUMBER
621-64-7
622-96-8
624-18-0
624-83-9
624-92-0
626-43-7
630-20-6
632-79-1
634-66-2
634-90-2
634-93-5
635-22-3
636-21-5
640-19-7
646-06-0
677-21-4

680-31-9
684-93-5
CHEMICAL NAME
1-Propanamine, N-nitroso-N-propyl-
aka: Nitrosodipropylanine
Benzene, l-ethyl-4-methyl-
aka: p-Ethyl toluene
1 , 4-Benzenediaaine dihydrochloride
aka: p-Phenylenedianine dihydrochloride
Methyl isocyanate
Disulfide, dimethyl-
Benzenamine , 3 , 5-dichloro-
Ethane , 1,1,1, 2-tetrachloro-
Tetrabromophthalic anhydride
Benzene, 1,2,3,4-tetrachloro-
Benzene , 1,2,3, 5-tetrachloro-
Benzenamine , 2,4, 6-tr ichloro-
Benzenanine, 4-chloro-3-nitro-
o-Toluidine hydrochloride
Acetanide, 2-fluoro-
1,3-Dioxolane
Ethane, trifluoronethyl-

Hexajnethylphosphoramide
N-Nitroso-N-methylurea
RULE CODE
srllO
sr313
d3
Pi
d3
sr313
ml
Pi
dl
d20
P23
d27
Pi
dl
Pi
dl
Pi
dl
Pi
dl
t35*
sr313
t35
P7
d2
P3
d3
rl
S2
sr313
sr313
                  37
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL
                LISTED PY CAS NUMBER
            NAMES
CM MBER
685-91-6
688-84-6
689-12-3
69T-42-2
696-28-6
757-58-4
759-73-9
765-34-4
811-97-2
812-03-3
818-61-1
8 5-0
823-40-5
827-94-1
828-00-2
842-07-9
868-77-9
872-50-4
919-62-0
924-16-3
CHEMICAL NAME RULE CODE
Acatanida, N,N-diethyl-
2-Propenoic acid, 2 -methyl-, 2-ethylhexyl ester
2-Propenoie acid, 1-methylethyl ester
Arsine, diethyl-
Arsonous dichloride, phenyl-
Tetraphosphoric acid, hexaethyl ester
aJca: Hexaethyl tetraphosphate
N-Nitroso-N-ethylurea
Glycidyl aldehyde
Ethane, 1, 1,1,2 -tetrafluoro-
aka : 1,1,1, 2-Tetraf luoroethane
HFC-124a
Propane , 1,1,1, 2-tetrachloro-
2-Propenoic acid, 2-hydroxyethyl ester
Hexane , 1 , 6-diisocyanato-
aka: 1,6-Hexamethylene diisocyanate
1 , 3-Benzenediamine , 2-methyl-
aka : 2 , 6-Diamino-l-methylbenzene
Benzenamine, 2 , 6-dibromo-4-nitro-
l,3-Dioxan-4-ol, 2,6-dimethyl-, acetate
C.I. Solvent Yellow 14
2-Propenoic acid, 2-nethyl-, 2-hydroxyethyl ester
N-Methylpyrrolidone
aka: NMP
1-Butanol, 3 -methyl-, phosphate (3:1)
1-Butananine, N-butyl-N-nitroso-
d20
Pi
Pi
die
d!6
t35*
dl6
sr313
t35*
d28
d20
Pi
t46
pl9
C2
d20
Pi
d3
Pi
dl
d20
sr313
Pi
t51
C2
sr313
   aka:   Nitrosodibutylaaine
                  38
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
925-60-0
930-22-3
930-37-0
933-75-5
939-97-9
961-11-5
989-38-8
992-59-6
1000-82-4
1024-57-3
1070-78-6
1120-71-4
1129-42-6
1139-30-6

2-Propenoic acid, propyl ester
oxirane, ethenyl-
Oxirane , ( methoxynethy 1 ) -
2,3, 6-Trichlorophenol
Benzaldehyde, 4- ( 1, 1 -dimethyl ethyl )-
aka: p-tert-Butylbenzaldehyde
PTBB
Tetrachlorvinphos
C.I. Basic Red l
1-Naphthalenesulf onic acid , 3 , 3 ' - [ ( 3 , 3 ' -dimethyl
[l,l'-biphenyl]-4,4'-diyl)bis(azo)]bisC4-anino-,
disodiua salt
Urea , (hydroxymethyl ) -
aka : Methylolurea
Heptachlor epoxide
Propane, 1,1,1,3-tetrachloro-
1 , 2-Oxathiolane , 2 , 2 -dioxide
aka: Propane sultone
Urea, (hexahydro-6-methyl-2-oxo-4-pyrimidinyl) -
5-Oxatricyclo[8.2.0.0 (4,6) ]dodecane, 4,12,12-
RULE CODE
Pi
dl
Pi
dl
t31
a8
d!7
sr313
sr313
dl
P4
d4
srlio*
d20
sr3 '. 3
s5->
Pi
              trinethyl-9-methylene-, [1R-(1R*,4R*,6R*,10S*)]-

1163-19-5    Decabronodiphenyl oxide
              aka: Decabronodiphenyl ether
1185-81-5
1197-37-1
Stannane, dibutylbis(dodecylthio)-
 aka:  Dibutyltin bis(lauryl mercaptide)

1,2-Benzenedianine, 4-ethoxy-
 aka:  o-Phenylenedianine, 4-ethoxy-
1208-52-2    Benzenamine, 2-[(4-aminophenyl)methyl]-
                             39
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS)  NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
C JMBER
1241-94-7

1300-71-6
1309-64-4

1313-13-9

1313-27-5

1314-20-1
1314-62-1

1319-77-3


iirM.38-6


1321-64-8


1321-65-9

CHEMICAL NAME RULE CODE
Phosphoric acid, 2-ethylhexyl diphenyl ester

Phenol, dimethyl-
Antimony oxide (Sb (2) O (3))
aka: Antimony trioxide
Manganese oxide
aka: Manganese dioxide
Molybdenum oxide
aka: Molybdenum trioxide
Thorium dioxide
Vanadium oxide
aka: Vanadium pentoxide
Phenol, methyl-
aka: Cresols

Benzene, diisocyanatomethyl- (unspecified isomer)
aka: Unspecified toluene diisocyanate

Naphthalene, pentachloro-


Naphthalene, trichloro-

Pl
dl
d20
Pi
dl
Pia

pis
sr313
sr313
pl8

srllO
Pi
sr313
ml
c2
d20
a5
Pi
dl
a5
P*
1328-53-6    C.I. Pigment Green 7
1330-20-7    Benzene, dimethyl-  (Total xylenes — srllO)
1330-61-6    2-Propenoic acid, isodecyl ester
1330-78-5    Phosphoric acid, tris(methylphenyl) ester

1331-47-1    [l,l'-Biphenyl]-4,4'-diamine, dichloro-
1332-21-4    Asbestos
                             40
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL
                           LISTED BY CAS NUMBER
                                                  NAMES
CAS NUMBER
CHEMICAL NAME
RULE CODE
1333-41-1


1335-87-1
1336-36-3


1344-28-1

1345-04-6


1429-50-1




1464-53-5
1477-55-0

1582-09-8

1623-19-4

1634-04-4
1649-08-7
              aka:  Asbestiform mineral(s)
Pyridine, methyl-
Naphthalene, hexachloro-
1335-68-2    Naphthalene, tetrachloro-
Polychlorinated biphenyls
 aka:  PCBs

Aluminum oxide

Antimony sulfide  (Sb (2) S (3))
 aka:  Antimony trisulfide

Phosphonic acid,  [l,2-ethanediylbis[nitrobii
 (methylene)]]tetrakis-
 aka:  EDTMPA

2,2'-Bioxirane
1,3-Benzenedimethanamine

Trifluralin

Phosphoric acid, tri-2-propenyl ester

Propane, 2-methoxy-2-methyl-
 aka:  Methyl tert-butyl ether
Ethane, l,2-dichloro-l,l-difluoro-
 aka: l,2-Dichloro-l,l-difluoroethane
      HCFC-132b
   X6
   a3
   dl
   sr313

   r2
   d6

   a5
   Pi
   dl
   sr313

   35
   Pi
   dl

   xl
   sr313

   sr313*

   Pi
   dl

   a!2
   t35*
   Pi
   dl
   sr313

   P3

   sr313

   c2

   t41
   pl5
   d!9
   sr313
   t50

   d23
                              41
                                       (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
CAJ fBER
16 )-4
1675-54-3
1717-00-6
1746-01-6
1817-73-8
1825-30-5
1825-31-6
1836-75-5
1888-71-7
18 5-6
19.. .4-9
1937-37-7
1940-42-7
2050-69-3
2050-72-8
2050-73-9
2050-74-0
2050-75-1
CHEMICAL NAME RULE CODE
2-Propenoie acid, 1 , 1-dinethylethyl ester
Oxirane, 2, 2'-[ (l-methylethylidene)bis(4,l-
phenyleneoxynethylene) ]bis-
Ethane , 1 , 1-dichloro-l-f luoro-
aka : 1 , 1-Dichloro-l-f luoroethane
HCFC-141b
Tetrachlorodibenzo-p-dioxin
Benzenamine, 2-bromo-4 , 6-dinitro-
Naphthalene , 1 , 5-dichloro-
Naphthalene, 1 , 4-diehloro-
Nitrofen
1-Propene , 1,1,2,3,3,3 -hexachloro-
Chlorothalonil
Atrazine
2 , 7-Naphthalenedisulf onic acid , 4-anino-3- [ [ 4 ' -
[ (2 , 4-dianinophenyl) azo] [ 1, I'-biphenyl] -4-yl]azo]-
5-hydroxy-6-(phenylazo)-, disodium salt
aka: C.I. Direct Black 38
4-Brono-2 , 5-dichlorophenol
Naphthalene , 1 , 2-dichloro-
Naphthalene , 1 , 6-dichloro-
Naphthalene , i , 7-dichloro-
Naphthalene , 1 , 8-dichloro-
Naphthalene, 2 , 3-dichloro-
Pl
dl
d28
srllO
X7
Pi
dl
a5
dl
a5
dl
sr313
d!6
sr313
srllO
sr313
Pi
dl
t31
as
dl
a5
dl
as
dl
a5
dl
a5
dl
                  42
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS  & CHEMICAL NAMES
                            LISTED  BY CAS NUMBER
CAS NUMBER
2052-07-5

2065-70-5

2082-81-7
2113-57-7

213S-89-2
2150-54-1


2156-96-9
2164-17-2
2198-75-6

2198-77-8

2210-28-8
2210-79-9
2223-82-7

2224-15-9
2234-13-1



2238-07-5

2303-16-4
2358-84-1
CHEMICAL NAME RULE CODE
1,1' -Biphenyl , 2 -bromo-
afca : 2 -Bromob ipheny 1
Naphthalene , 2 , 6-dichloro-

2-Propenoic acid, 2-methyl-, 1,4-butanediyl ester
1,1' -Biphenyl , 3 -bromo-
aka : 3 -Bromob ipheny 1
2-Chlorobensotrichloride
2 , 7 -Naphtha lenedisulfonic acid, 3 , 3 '-[ (3 , 3 '-dimethyl
[l,l'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-
dihydroxy-, tetrasodium salt
2-Propenoic acid, decyl ester
Fluometuron
Naphthalene, 1,3-dichloro-

Naphthalene , 2 , 7-dichloro-

2-Propenoic acid, 2-methyl-, propyl ester
Oxirane , [ ( 2-methylphenoxy ) methyl ] -
2-Propenoic acid, 2,2-dimethyl-l,3-propanediyl ester
t
Oxirane, 2,2'-[l,2-ethanediylbis(oxymethylene) Ibis-
Naphthalene, octachloro-



Oxirane, 2,2'-[oxybis(methylene) ]bis-

Diallate
2-Propenoic acid, 2-methyl-, oxydi-2 , 1-ethanediyl
35

. aS
dl
Pi
sS

t35*
dl


Pi
sr313
aS
dl
aS
dl
Pi
dl
Pi

dl
aS
Pi
dl
sr313
Pi
dl
sr313
Pi
              ester

2385-85-5    Mirex
                              43                     (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS)  NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
             Oxirane, octyl-                                        r2
                                                                    dl

2425-01-6    Oxirane, 2,2'-[l,4-phenylenebis(oxynethylene)]bis-     dl

2425-79-8    Oxirane, 2,2'-[l,4-butanediylbis(oxymethylene)]bis-    pi
                                                                    dl

2426-08-6    Oxirane, (butoxynethyl)-                               pi
                                                                    dl

2426-54-2    2-Propenoie acid,  2-(diethylamino)  ethyl ester         pi

2429-71-2    l-Naphthalenesulfonic acid,  3,3'-[(3,3'-dinethoxy      dl
              [l,l'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-hydroxy-f
              disodiua salt

2429-73-4    2,7-Naphthalenedisulfonic acid,  5-anino-3-[[4'-[(7-    dl
              amino-l-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-
              biphenyl]-4-yl]azo]-4-hydroxy-, trisodiua salt

2429-74-5    2,7-Naphthalenedisulfonic acid,  3,3'-[(3,3'-           dl
              dimethoxy [ 1,1'-biphenyl ]-4,4**-diyl) bis (azo)] bis [5-
              amino-4-hydroxy-, tetrasodiua salt

2    79-0    Benzole acid, S-[[4'-[(l-aaino-4-sulfo-2-              dl
              naphthalenyl)azo][l,l'-biphenyl]-4-yl]azo]-2-
              hydroxy-, disodium salt

2429-81-4    Benzole acid, 5-[[4'-[[2,6-diaaino-3-[[8-hydroxy-3,6   dl
              -disul«o-7-[(4-sulfo-l-naphthalenyl)azo]-2-
              naphthaleny1]azo]-5-methyIphenyl]azo] [1,1'-
              biphenylJ-4-yl]azo]-2-hydroxy-, tetrasodiua salt

2429-82-5    Benzoic acid, 5-[[4'-(7-amino-l-hydroxy-3-sulfo-2-     dl
              naphthalenyl)azo][1,l'-biphenyl[-4-yl]azo]-2-
              hydroxy-, dispdiua salt

2429-83-6    2,7-Naphthalenedisulfonic acid,  4-aaino-3-[[4'[(2,4-   dl
              dianino-5-methyIphenyl)azo][1,1'-biphenyl]-4-yl]azo]
              -5-hydroxy-6-(phenylazo)-,  disodiua salt

2429-84-7    Benzoic acid, 5-[[4'-(2-aoino-8-hydroxy-6-sulfo-l-     dl
              naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-2-
              hydroxy-, disodiun salt

2432-99-7    11-Aminoundecanoic acid                                aio
              aka:  11-AA                                           SB
                             44                     (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
2455-24-5
2461-15-6
3461-13-9
2499-95-8
2528-36-1
2530-83-8
2530-85-0
2536-05-2
2556-36-7
2577-72-2
2586-57-4
CHEMICAL NAME RUI
2-Propenoic acid, 2 -methyl-, [tetrahydro-2-furanyl]
methyl ester
oxirane , [ [ ( 2 -ethylhexy 1 ) oxy ] methyl ] -
Oxirane, [ (dodecyloxy) methyl ] -
2-Propenoic acid, hexyl ester
Phosphoric acid, dibutyl phenyl ester
Silane, trimethoxy [3- (oxiranylmethoxy) propyl ] -
2-Propenoic acid, 2-methyl-, 3-(trimethoxysilyl)
propyl ester
Benzene, lf l'-methylenebis[2-isocyanato-
Cyclohexane , 1 , 4-diisocyanato-
3 , 5-Dibromosalicylanilide
1,3-Naphthalenedisulfonic acid, 4-aaino-5-hydroxy-6-
iE CODE
Pi
dl
Pi
dl
Pi
Pi
dl
Pi
dl
Pi
c2
d20
C2
d20
t31
dl
2586-58-5




2602-46-2




2610-05-1




2650-18-2

2687-25-4



2763-96-4
 [[4r-[(2-hydroxy-l-naphthalenyl)azo]-3,3'-dimethoxy
 [1,1'-biphenylI-4-yl]azo-,  disodium salt

Benzole acid, S-[[4'-[[2,6-diamino-3-methyl-5-[(4-     dl
 sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]
 -2-hydroxy-, disodiua salt

2,7-Naphthalenedisulfonic acid,  3,!'-[[1,1'-           pi
 biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-,   dl
 tetrasodium salt                                      sr3l3

1,3-Naphthalenedisulfonic acid,  6,6'-[(3,3'-           pi
 dimethoxy[l,l'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-    dl
 amino-5-hydroxy-,  tetrasodiua salt

C.I. Acid Blue 9, diamaoniuD salt                      sr~.:

1,2-Benzenediamine, 3-methyl-                          pi
 aka:  1,2-Diamino-3-methylbenzene                     d:

3(2H)-Isoxazolone,  5-(aminomethyl)-                    -
                             45
                                      (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAi IBER
27 1-9
2832-40-8
2855-19-8
2861-02-1
2857-47-2
2873-89-0
CHEMICAL NAME BITT.P rnn^
Benzene, l,3-bis(l-isocyanato-l-methylethyl) -
C.I. Disperse Yellow 3
Oxirane, decyl-
2 , 6-Anthracenedisulf onic acid, 4 , 8-diaaino^9 , 10-
dihydro-l,5-dihydroxy-9,10-dioxo-, disodium salt
2-Propenoic acid, 2 -methyl-, 2-(dimethylamino)ethyl
ester
Ethane , 2-chloro-l ,1,1, 2-tetraf luoro-
c2
d20
sr313
r2
Pi
dl
pl7
d22
Pi
d28
              aka: 2-Chloro-l,1,1,2-tetrafluoroethane
                   HCFC-124
2893-80-3    Benzoic acid, 5-[[4'-[[2,4-dihydroxy-3-[(4-            dl
              sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-y1]azo]
              -2-hydroxy-, disodium salt
2897-60-1    Silane, diethoxymethyl[3-(oxiranylmethoxy)propyl]-     dl
29    5-9    Benzoic acid, 3-chloro-, methyl ester                  pi
30    7-2    1-Tridecanol, phosphate (3:1)                          c2
3076-04-8    2-Propenoic acid, tridecyl ester                       pi
3083-25-8    Oxirane, (2,2,2-trichloroethyl)-                       pi
              aka: Trichlorobutylene oxide                          dl
                   TCBO                                             s9
3101-60-8    Oxirane, [[4-(1,1-dimethylethyl)phenoxy]methyl]-       pi
                                                                    dl
3118-97-6    C.I. Solvent Orange 7                                  sr313
3132-64-7    Oxirane, (bromomethyl)-                                r2
              aka: Epibromohydrin                                   pi
                   EBB                                              dl
                                                                    S9
3165-93-3    Benzenamine, 4-chloro-2-methyl-, hydrochloride         540
3173-72-6    Naphthalene, 1,5-diisocyanato-                         c2
                             46
(06/30/90)
-------
           CHgMICAL ABSTRACT  SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                            LISTED BY CAS NUMBER
CAS NUMBER
3194-55-6


3234-28-4

3266-23-7

3288-58-2

3296-90-0

3319-31-1


3322-93-8


3389-71-7



3530-19-6


3531-19-9
3567-65-5


3618-72-2



3618-73-3

CHEMICAL NAME RULE CODE

aka: Hexabromocyelododecana

Oxirane, dodecyl-

Oxirane, 2,3-dimethyl-

Phosphorodithioic acid, O,O-diethyl-S-nethyl ester
aka : O , O-Diethyl-S-nethyldithiophosphate
1 , 3-Propanediol , 2 , 2-bis (bromomethyl ) -
aka: Dibromoneopentyl glycol
1,2,4-Benzenetricarboxylic acid, tris(2-ethylhexyl)
ester
aka: Tris(2-ethylhexyl) trimellitate
Cyclohexane , 1 , 2-dibromo-4- ( 1 , 2-dibromoethyl ) -


Bicyclo[2 , 2 , l]hepta-2 , 5-diene, 1,2,3,4,7,7-
hexachloro-


1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-
ethoxyphenyl ) azo] [1,1' -biphenyl ] -4-yl ] azo ] -7-
hydroxy-, disodiua salt
Benzenanine, 2-chloro-4 , 6, -dinitro-
1 , 3-Naphthalenedisul f onic acid , 7-hydroxy-8- [ [ 4 ' -
[ [4- [[(4-methylphenyl)sulfonyl]oxy]phenyl] azo ][!,!' -
biphenyl] -4-yl] azo]-, disodium salt
Acetamide , N- [ 5- [bis [ 2- ( acety loxy ) ethyl ] amino ] -2-
[ (2-bromo-4 , 6-dinitrophenyl ) azo] -4-methoxyphenyl ] -
aka: C. I. Disperse Blue 79:1
DB-79:1
Acetamide, N- [5- [bis [2- (acety loxy) ethyl] amino] -2-
[ (2-chloro-4 , 6-dinitrophenyl) a zo] -4-methoxyphenyl ]-
pi
f*
d27
p23
r2
dl
r2
dl
t35*
die
d20
P23
P7
d2

r2
P6
d8
a6
si
PS
t**+
d7
dl


dl
dl


pl6
d21
t48

p!6
d21
3626-28-6    2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-   dl
              [[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]
              -6-(phenylazo)-, disodiun  salt


                              47                     (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
Cfi MBER
1
36 0-2
3663-23-8
3689-24-5
3761-53-3
3772-34-3
3775-90-4
3844-45-9
3953-10-4
3956-55-6
4C---11-9
4016-14-2
4098-71-9
4162-45-2
4170-30-3
4200-55-9-
4335-09-5
4549-40-0
4680-78-8
CHEMICAL NAME RULE CODE
1,2-Benzenedicarboxylic acid, diundecyl ester
aka: Diundecyl phthalate (branched and linear
isoaers)
1 , 2 -Benzenediamine , 4 -butyl-
aka: Benzenedianine, 4 -butyl-
o-Phenylenediaaine, 4 -butyl -
Tetraethyldithiopyrophosphate
C,I. Food Red 5
Pantachloropher.yl laurate
2-Propenoic acid, 2-aethyl-, 2-[ (1,1, -dimethyl ethyl)
-amino] ethyl ester
C.I. Acid Blue 9, disodiun salt
2-Propenoic acid, 2-ethylbutyl ester
Acetanide , N- [ 5- [bis ( 2- ( acetyloxy ) ethyl ] amino ] -2-
[ ( 2-bromo-4 , 6-dinitrophenyl ) azo ] -4-ethoxyphenyl ] -
Oxirane , ( ethoxynethy 1 ) -
Oxirane , [ ( 1-methy lethoxy ) methyl ] -
cyclohexane , 5-isocyanato-l- ( isocyanatonethyl ) -
1,3,3-trimethyl-
Tetrabromobisphenol A bisethoxylate
2-Butenal
aka: Crotonaldehyde
Phosphoric acid, tris(decyl) ester
2 , 7-Naphthalenedisul f onic acid , 4-aaino-5-hydroxy-6 [
[4'-((4-hydroxyphenyl)azo][l,l'-biphenyl]-4-yl]azo]-
3-[(4-nitrophenyl)azo]-f disodium salt
N-Nitrosoaethylvinylamine
C.I. Acid Green 3
t44
dl
r2
P3
d3
t35*
sr313
t31
Pi
sr313*
Pi
pis
d!9
Pi
dl
Pi
dl
C2
d20
t31
pl9
die
t47
C2
dl
sr313
sr313
                  48
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
4835-11-4
4889-45-6
5026-74-4
5042-55-7
5124-30-1
5131-58-8
5131-60-2
5131-66-8
5216-25-1
5255-75-4
5307-02-8
CHEMICAL NAME
1 , 6-Hexanedianine , N , N ' -dibuty 1-
Phosphoric acid, trioctadecyl ester
Oxiranemethanamine , N- [ 4 - ( oxirany Imethoxy ) pheny 1 ] -N-
( oxirany Imethyl) -
1,3-Benzenediamine, 5-nitro-
aka: m-Phenylenediamine, 5-nitro-
Cyclohexane, 1, l'-methylenebis[4-isocyanato-
1 , 3 -Benz enediamine , 4 -ni tro-
aka: m-Phenylenediamine, 4-nitro-
1 , 3-Benzenediamine, 4-chloro-
aka: m-Phenylenediamine, 4-chloro-
2-Propanol, 1-butoxy-
4 -Chlorobenzotrichlor ide
Oxirane , [ ( 4 -nitrophenoxy ) methyl ] -
1 , 4-Benzenediamine, 2-methoxy-
aka: p-Oiaminoanisole
RULE CODE
Pi
C2
dl
r2
P3
d3
c2
r2
P3
d3
P3
d3
P21
d25
t35
dl
P3
d3
5307-14-2    1,4-Benzenediamine, 2-nitro-
              aka:  p-Phenylenediamine, 2-nitro-
5344-82-1    Thiourea,  (2-chlorophenyl)-
              aka:  1-(o-chloropheny1)thiourea
5388-62-5    Benzenamine, 4-chloro-2,6-dinitro-
                                                                    P2
5455-98-1
5470-11-1

5493-45-8

5536-61-8
             IH-Isoindole-l,3(2H)-dione, 2-(oxiranyImethyl) -
             Hydroxylamine hydrochloride
              aka:  Hydroxylamnonium chloride
             1,2-Cyclohexanedicarboxyiic acid, bis
              (oxiranyImethyl) ester
             2-Propenoic acid, 2-methyl-, sodium salt
                             49
                                                    (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS)  NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER


CA     [BER          "
CA
58
       ,-1



     05-2
   IICAL NJ  	
Benzene, l-isocyanato-2-[(4-isocyanatopheny1)
 methyl]-
RULE CODE
   C2
   d20
6033-05-2    Morphinan-3,6-diol,  7,a-didehydro-4,5-epoxy-17-
              methyl- [5alpha,6alpha]-, (Z)-9-octadecenoate (salt)

6106-46-3    Benzeneacetic acid,  alpha-(hydroxymethyl)-, 9-methyl
              ~3-oxa-9-azatricyclo[3.3.1.0 (2,4)]non-7-yl ester,
              [7(S)-[lalpha,2beta,4beta,Salpha,7beta)]-, compound
              with methyl nitrate (1:1)

6106-81-6    Benzeneacetic acid,  alpha-(hydroxymethyl)-, 9-methyl
              -3-oxa-9-azatricyclo[3.3.1.0 (2,4)]non-7-yl ester,
              N-oxide, hydrobromide, [7(S)-(lalpha,2beta,4beta,
              Salpha,7beta)]-

6145-73-9    l-Propanol, 2-chloro-,  phosphate (3:1)


6163-73-1    Ethanol, 2-methoxy-, phosphate (3:1)

6178-32-1    Oxirane, [(4-nonylphenoxy)methyl]-
              aka:  Propane,  i,2-epoxy-3-(p-nonylphenoxy)-

6219-67-6    1,3-Benzenediamine,  4-methoxy-, sulfate
              aka:  m-Phenylenediamine, 2-nitro-


6219-71-2    1,4-Benzenediamine,  2-chloro-, sulfate
              aka:  p-Phenylenediaaine, 2-chloro-, sulfate


6219-77-8    1,2-Benzenediamine,  4-nitro-, dihydrochloride
              aka:  o-Phenylenediamine, 4-nitro-, sulfate
                                                       Pi


                                                       Pi




                                                       Pi
                                                                    p20
                                                                    d24

                                                                    c2

                                                                    dl
                                                                    r2
                                                                    P3
                                                                    d3

                                                                    r2
                                                                    P3
                                                                    d3

                                                                    r2
                                                                    P3
6247-34-3    2-Anthracenedisulfonic acid-, 4-[[4-(acetylaaino)
              phenyl]amino]-l-amino-9,lO-dihydro-9,10-dioxo-

6283-25-6    Benzenaaine, 2-chloro-5-nitro-
                                                                    F
                                                                    •4
6358-29-8    1,3-Naphthalenedisulfonic acid, 8-[(4'-[(4-
              ethoxyphenyl)azo]-3,3'-dimethyl[1,1'-bipheny1]-4-yl]
              azo]-7-hydroxy-, disodium salt

6360-54-9    Benzoic acid, 5-[[4'-[[2,6-diaaino-3-methyl-5-[(4-
              sulfophenyl)azo)phenyl]azo][1,I'-biphenyl]-4-yl]azo]
              -2-hydroxy-3-methyl-, disodium salt
                             50
                                                    (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
6369-59-1
6422-86-2
6424-85-7
CHEMICAL NAME
1,4-Benzenediamine, 2 -methyl-, sulfate
1,4-Benzenedicarboxylic acid, bis(2-ethylhexyl)
ester
2-Anthracenesulfonie acid, 4-[[4-(acetylamino)
phenyl ] anino ] -l-amino-9 , 10-dihydro-9 , 10-dioxo-
monosodiua salt
RULE CODE
Pi
d3
P7
d2
P17
d22
6449-35-0




6484-52-2

6637-88-3




6656-03-7





6739-62-4





7005-72-3


7195-45-1



7221-93-4


7320-37-8



7328-97-4



7332-46-9


7390-81-0



7422-52-8
1-Naphthalenesulfonic acid, 3-[[4'-[(6-amino-l-
 hydroxy-3-sulfo-2-naphthalenyl)azo]-3,3'-dimethoxy
 [l,l'-biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt

Ammonium nitrate  (solution)

Benzoic acid, 5-[[4'-[(2,6-diamino-3-methyl-5-
 sulfophenyl)azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]
 azo]-2-hydroxy-, disodium salt

Cuprate(3-), [mu-[7-[[3,3'-dihydroxy-4'-[[1-hydroxy-
 6-(phenylamino)-3-sulfo-2-naphthalenyl]azo][1,1'-
 bipenyl]-4-yl]azo]-8-hydroxy-l,6-naphthalene
 disulfonato(7-)]]di-, trisodium

Benzoic acid, 2-[[2-anino-6-[[4'-[(3-carboxy-4-
 hydroxypheny1)azo]-3,3'-dimethoxy[1,1'-biphenyl]-4-
 yl]azo]-5-hydroxy-7-sulfo-1-naphthalenyl]azo]-5-
 nitro-, trisodium salt

4-Chlorophenyl phenyl

1,2-Benzenedicarboxylic acid, bis(oxiranylmethyl)
 ester

Endrin aldehyde/endrin

Oxirane, tetradecyl-
Oxirane, 2,2',2",2'"-[l,2-ethanediylidenetetrakis
 (4,1-phenyleneoxymethylene).] tetrakis-

Ethanol, 2-(2-butoxyethoxy)-, phosphate  (3:1)

Oxirane, hexadecyl-
Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[3-
 (oxiranylmethoxy)propyl]-
dl



sr313

dl



dl





dl




srllO

dl


srllO

Pi
dl

dl


c2

r2
dl
                              51
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CA     tBER	
74	-0-5    Aluainua (fume or dust)
7439-92-1    Lead

7439-96-5    Manganese

7439-97-6    Mercury

7439-98-7    Molybdenum
7440-02-0    Nickel

7440-14-4    Radium
7440-22-4    Silver

7440-24-6    Strontium
74    18-0    Thallium

7440-29-1    Thorium
7440-31-5    Tin
7440-36-0    Antimony


7440-38-2    Arsenic

7440-39-3    Barium

7440-41-7    Beryllium

7440-42-8    Boron
7440-43-9    Cadmium
                 srllO
                 sr313
                 srllO
                 sr313
                 srllO
                 sr313
                 srllO
                 srllO*
                 sr313
                 srllO
                 pl8
                 srllO
                 sr313
                 srllO
                 srllO
                 d20
                 sr313
                 srllO
                 srllO
                 srllO
                 Pi
                 dl
                 sr313
                 srllO*
                 sr3l3
                 srllO
                 sr313
                 srllO*
                 sr313
                 srl'.T
                 sri::*
                             52
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER


7440-47-3

744'0-48-4


7440-50-8

7440-61-1
7440-62-2

7440-66-6

7446-09-5
7446-81-3
7534-94-3

7550-45-0
7647-01-0
7647-10-1

7664-38-2
7664-39-3

7664-41-7

7664-93-9

7665-72-7
7681-49-4
7697-37-2


Chromium

Cobalt


Copper

Uranium
Vanadium (fume or dust)

Zinc (fume or dust)

Sulfur dioxide
2-Propenoic acid, sodium salt
2-Propenoic acid, 2 -methyl-, 1,7,7-trimethylbicyclo
[2.2.1]hept-2-yl ester, exo-
Titanium tetrachloride
Hydrochloric acid
Palladium chloride
aka: Palladium (II) chloride
Phosphoric acid
Hydrofluoric acid
aka: Hydrogen fluoride
Ammonia

Sulfuric acid

Oxirane, [ ( l, l-dimethylethoxy ) methyl ] -
Sodium fluoride
Nitric acid

sr3i3
srllO
sr313
srllO
d20
sr313
srllO
sr313
srllO
srllO
sr313
srllO
sr3l3
srllO
Pi
Pi

sr313
sr313
pl8

sr313
p!8
sr313
srllO
sr313
srllO
sr313
dl
P13
sr:'-3
                   53
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS)  NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
C 1MBER
7 L4-0
7726-95-6
7757-82-6
7761-88-8
7782-49-2
7782-50-5
7783-06-4
7783-20-2
7785-87-7
7™ 19-8
7803-55-6
8001-35-2
8001-58-9
CHEMICAL NAME
Phosphorus
Bromine
Sodiua sulfate (solution)
Nitric acid, silver (1+) salt
aka: Silver nitrate
Selenium
Chlorine
Hydrogen sulfide
Ammonium sulfate (solution)
Sulfuric acid, manganese (2+) salt (1:1)
aka : Manganese ( II ) sulfate
Hydroxylamine
aka: Oxammonium
Ammonium vanadate
Toxaphene
Creosote
RULE CODE
pis
sr3l3
pl8
sr313*
pl8
p!8
srllO
sr3l3
ml
sr313
srllO
sr313
plB
ml
t35*
srllO
sr313
sr313**
srllO
8014-91-3
9011-05-6



9016-87-9



10028-17-8
Benzoic acid, 3,3'-[(3,7-disulfo-l,5-
 naphthalenediyl) bis [ azo (6-hydroxy-3, l«-phenylene) azo
 [6 (or 7)-sulfo-4,l-naphthalenediyl]azo[l,l'-
 biphenyl]-4,4'-diylazo]]bis[6-hydroxy-, hexasodium
 salt

Urea, polymer with formaldehyde
Isocyanic acid, polymethylenepolyphenylene ester
Tritium
dl
pll
dll

c2
d20

srllO
                             54
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS  &  CHEMICAL NAMES
                            LISTED BY CAS NUMBER
CAS NUMBER
10034-93-2
10039-54-0
10043-92-2
10046-00-1
10043-04-4
10061-01-5
10061-02-6
10124-43-3

10347-54-3
10361-37-2
10401-50-0
10427-00-6
10436-39-2
10588-01-9
11096-82-5
11097-69-1
11104-28-2
11141-16-5
12001-29-5
12001-85-3
12070-12-1
CHEMICAL NAME RULE CODE
Hydrazine sulfate
Hydroxylaaine sulfate (2:1)
aka: Hydroxylamaonium sulfate
Radon & compounds
Hydroxylanine sulfate (1:1)
aka: Hydroxylaaine acid sulfate
Chlorine dioxide
cis-1, 3 -DitChloropropene
trans-1, 3-Dichloropropene
Sulfuric acid, cobalt (2+) salt (1:1)
aka: Cobaltous sulfate
Cobalt (II) sulfate
Cyclohexane , 1 , 4 -bis ( isocyanatomethyl ) -
Barium chloride
C.I. Direct Blue 218
2-Furanmethanol, tetrahydro-, phosphate
1-Propene ; 1,1,2, 3-tetrachloro-
Sodiun dichromate
PCBs — Aroclor 1260
PCBs — Aroclor 1254
PCBs — Aroclor 1221
PCBs — Aroclor 1232
Chrysotile [ (Mg (3))(H (2))((SiO (4)) (2))(H (2)0)]
aka* Asbestiform mineral (s)
Naphthenic acids, zinc salts
Tungsten carbide
sr313
ml
srllO
ml
sr3l3
srllO
srllO
pl8

c2
d20
p!8
dl
C2
d20
X8
srlio
srllO
srlio
srlio
a3
dl
d2
P-
12122-67-7
Zineb
                              55
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES' (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
C 7MBER
1. -73-5
12217-79-7
12427-38-2
12513-27-8
12604-53-4
12672-29-6
12674-11-2
13048-33-4
13236-02-7
13414-54-5
] -55-6
13463-67-7
13561-08-5
13654-09-6

13674-84-5
13674-87-8
CHEMICAL NAME
Asbestos, grunerite
aka: Asbestifonn mineral (s)
9 , 10-Anthracenedione , 1 , 5-diaminochloro-4 , 8-
dihydroxy-
Maneb
Zinc borate hydrate
aka: ZB-2335
Ferromanganese
PCBs — Aroclor 1248
PCBs — Aroclor 1016
2-Propenoic acid, 1,6-hexanediyl ester
Oxirane , 2,2', 2N- [1,2, 3-propanetriyltris
(oxymethylene) ]tris-
Benzene, l-[ (2-methyl-2-propenyl) oxy] -2-nitro-
Benzof uran, 2 , 3-dihydro-2 , 2-dimethyl-7-nitro-
Titaniua dioxide
Oxirane, 2, 2'-(oxiranylmethoxy) -1, 3-phenylene]bis
(methylene) ]bis-
aka: Decabroaobiphenyl
2-Propanol, l-chloro-, phosphate (3:1)
2-Propanol, 1,3-dichloro-, phosphate (3:1)
RULE CODE
a3
dl
P17.
d22
sr313
sr313
p!8
srllO
srllO
Pi
Pi
dl
P?
d5
P7
d5
sr313*
Pi
dl
s5

p20
d24
p20
d24
14228-73-0
14302-13-7
Oxirane, 2,2'-[l,4-cyclohexanediylbis                  dl
 (methyleneoxymethylane)]bis-
 aka: Cyclohexane, 1,4-bis[(2,3-epoxypropoxy)methyl]-

Copper, [l,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,   sr
 22,23,25-decachloro-29H,3lH-phthalocyaninato(2-)-
 N (29),N (30),N (31),N (32)]-, (SP-4-2)-
 aka:  C.I. Pigment Green 36
                             56
                                       (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
CAS NUMBER
14797-55-8
15117-48-3
15142-96-8
15646-96-5
15872-73-8
15965-99-8
16071-86-6
16110-89-7
16143-79-6
16245-77-5
16245-97-9
16532-79-9
16543-55-8
16715-83-6
16938-22-0
16984-48-8
17068-78-9
CHEMICAL NAME RULE CODE
Nitrates/nitrites
Plutonium- 2 3 9
Phosphonic acid, [1, 2-ethanediylbis[nitrilobis
(aethylene) ] ]tetrafcis-, hexasodiun salt
Hexane, 1 , 6-diisocyanato-2 , 4 , 4-trimethyl-
Phenol, 2,4-diamino-6-methyl-
aka : 4 , 6-Dianino-o-cresol
Oxirane , [ (hexadecyloxy) methyl ] -
Cuprate (2-), [ 5- [ [ 4 ' - [ [ 2 , 6-dihydroxy-3- [ ( 2-hydroxy-
5-sulf ophenyl) azo] phenyl ] azo] [1,1* -biphenyl ] -4-yl ]
azo]-2-hydroxybenzoato(4-) ]-, disodium
Benzenesulf onic acid, 4 [ (4 , 6-dichloro-l, 3 , 5-triazin-
2-yl)amino]-
cuprate(4-) , [mu-[[6,6'-[(3, 3'-dihydroxy[l,l'-
biphenyl ] -4-4 ' -diyl) bis (azo) ] bis [ 4-amino-S-hydroxy-
1, 3-naphthalenedisulfonato] ] (8-) ] ]di-f tetrasodium
1,4-Benzenediaaine, sulfate (1:1)
aka: p-Phenylenediamine, sulfate salt
p-PDA. (H)2 S(0)4
Oxirane , [ (octadecyloxy ) methyl ] -
4 -Bromobenzy 1 cyanide
N-Nitrosonornicotine
2-Propenoic acid, 2 -methyl-, 2-[bis(l-methylethyl)
amino] ethyl ester
Hexane , 1 , 6-diisocyanato-2 , 2 , 4-trimethyl-
Fluor ides/ fluorine/hydrogen fluoride
Anthopyllite
aka: Asbestiform mineral (s)
•^^^^^^^^^^^^
srllO
srllO
a!2
c2
d20
r2
P3
d3
dl
dl
sr313
Pi
dl
t36
P3
d3
t52
dl
t35
sr313
Pi
C2
d20
srllO
a3
dl
                  57
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
Cj MBER
11 39-2
17418-58-5
17557-23-2
17963-04-1
17977-09-2
18266-52-9
18495-30-2
18633-25-5
19660-16-3
21 -09-7
20217-01-0
20282-70-6
20816-12-0
20830-81-3
21429-43-6
21850-44-2
22092-38-2
24442-57-7
25085-99-8
CHEMICAL NAME RU]
2-Propanaaine, l-chloro-N,N-dinethyl-, hydrochlorida
9 , 10-Anthracene , l-aaino-4-hydroxy-2-phenoxy-
Cxirane, 2,2'-( (2,2-diaethyl-l, 3-propanediyl)bis-
(oxynethylene) ]bis-
S ilane , ethoxydiaethyl [ 3 -oxiranylnethoxy ) propy 1] -
aka : S ilane , [ 3 - ( 2 , 3 -epoxypropoxy ) propy 1 ]
ethoxydinethyl-
2-Propenoic acid, 2,2-dinitropropyl ester
1,4-Benzenediamine, 2-nitro-, dihydrochloride
aka: p-Phenylenediaaine, 2-nitro-, dihydrochloride
Propane , 1,1,2,3 -tetrachloro-
Oxirane, tridecyl-
2-Propenoic acid, 2,3-dibromopropyl ester
1 , 4-Benzenedianine , 2 , 5-dichloro-
aka : p-Phenylenediamine , 2 , 5-dichloro-
Oxirane , [ ( 2 , 4-dibromophenoxy ) methyl ] -
[1,1' -Biphenyl ] -4 , 4 ' -bis (diazoniua) , 3,3' -dinethoxy-
Osmiua tetroxide
Daunonycin
Acetaaide, N-[5-[bis[2-(acetyloxy)ethyl]anino]-2-
[ ( 2-chloro-4 , 6-dinitrophenyl ) azo] -4-ethoxyphenyl ] -
Tetrabronobisphenol-A-bis-2 , 3-dibroaopropyl ether
Oxirane, pentadecyl-
Ethanol, 1,2-dibroao-, acetate
Oxirane, 2,2'-[ (l-methylethylidene)bis(4,l-
pheny leneoxynethy lene ) ] b i s - , homopolymer
[£ CODE
Pi
pl9
d22
dl
dl
Pi
r2
P3
d3
r2
d20
dl
r2
d20
r2
P3
d3
dl
dl
sr313
t35*
p!6
d21
t31
r2
dl
Pi
Pi
dl
                  58
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS 6 CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER   CHEMICAL NAME
                                                    RULE CODE
25134-21-8

25154-55-6
25155-23-1

25168-06-3

25168-21-2

25168-24-5

25321-14-6

25321-22-6
25327-89-3
25376-45-8

25498-49-1

25550-14-5
4,7-Methanoisobenzofuran-l,3-dione, 3a,4,7,7a-         pi
 tetrahydromethyl-
Nitrophenol                                            srlio
Phenol, dimethyl-, phosphate (3:1)                     pi
                                                       dl
Phenol, (1-methylethyl)-                               p21
 aka:  Isopropyl phenol                                d25
Dibutyltin bis(isooctyl maleate)                       p7
 aka:  2-Butenoic acid, 4,4'-[(dibutylstannylene)bis   d2
        (oxy)]bis[4-oxo-, diisooctyl ester, (Z,Z)-
Acetic acid, 2,2'-[(dibutylstannylene)bis(thio)]       r2
 bis-, diisooctyl ester                                p7
 aka:  Dibutyltin S,S'-bis(isooctyl) mercaptoacetate   d2
Benzene, methyldinitro-                                sr3l3**
 aka:  Dinitrotoluene  (mixed isomers)
Benzene, dichloro (mixed isomers)                      sr3i3
Allyl ether of tetrabromobisphenol A                   t3l
Benzenediamine, ar-methyl-                             p3
 aka:  Diaminotoluene                                  d3
                                                       sr:: :
Propanol, [2-(2-methoxymethylethoxy)methylethoxy]-     p::
 aka:  Tripropylene glycol monomethyl ether            d:-
Benzene, ethylmethyl-                                  P'.
25550-98-5   Phosphorous acid, diisodecyl phenyl ester
              aka:  Diisodecyl phenyl phosphite
25551-13-7   Benzene, trimethyl-  (mixed isomers)

25584-83-2   2-Propenoic acid, monoester with 1,2-propanediol
25586-43-0   Naphthalene, chloro-
                              59
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS 6 CHEMICAL NAMES
                           LISTED BY CAS NUMBER
=A£ |BER_
25637-99-4
25640-78-2
25724-58-7
25852-70-4
26444-49-5
26447-14-3
26447-40-5
26471-62-5


26S 0-1
26636-01-1
26761-40-0
26761-45-5
26952-23-8
27288-44-4
CHEMICAL NAME RU1
Cyclodecane, hexabromo-
1,1' -Biphenyl , ( 1-methylethyl ) -
aJca: Isopropyl biphanyl
1,2-Benzenedicarboxylic acid, daeyl haxyl astar
Acetic acid, 2 , 2 ' , 2"- [ (butylstannylidyna) tris (thio j ]
tris-, triisooctyl aster
aka: Monobutyltin tris(isooctyl) marcaptoaeetate
Phosphoric acid, methylphenyl diphenyl ester
Oxirana , ( (aathylphanoxy ) methyl ] -
Benzene , 1,1' -methylenebis [ isocyanato-
Benzene , 1 , 3-diisocyanatomethyl-
aka: Toluene diisocyanate (mixed isoners)


3 (2H) -Isothiazolone, 2-octyl-
Acetic acid, 2,2'-[ (diaethylstannylene) bis (thio) ]
bis-, diisooctyl ester
aka: Dimethyl tin S,S'-bis(isooctyl) mercaptoacetate
1,2-Benzenedicarboxylic acid, diisodecyl ester
aka: Diisodecyl phthalate
Neodecanoic acid, 2,3-epoxypropyl ester
aka: Neodecanoic acid, oxiranylmethyl ester
l-Propenev dichloro-
Antimony tris(iso-octyl mercaptoacetate)
LE CODE
Pi
P6
d8
dl
P7
d2
Pi
dl
Pi
dl
C2
d20
sr3l3**
ml
srlio
C2
d20
r2
d20
r2
P7
d2
t44
Pi
dl
Pi
dl
dz
sr
27554-26-3
27753-52-2
 aka: ATOM
1,2-Benzenedicarboxylic acid, diisooctyl ester         d.
Nonabromobiphenyl (unspecified location of bromines)   s
                             60
                                      (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS)  NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER
27858-07-7
28108-99-8
28553-12-0
29385-43-1
29761-21-5
32052-51-0
32241-08-0
32360-05-7
32534-81-9
32536-52-0
32568-89-1
32588-76-4
33125-86-9
CHEMICAL NAME RULE CODE 1
Octabromobiphenyl , (ar , ar, ar , ar , ar ' , ar ' , ar ' , ar ' ) -
Phosphoric acid, (l-nethylethyl)phenyl diphenyl
ester
1,2-Benzenedicarboxylic acid, diisononyl ester
IK-Benzotriazole, methyl-
aka: Tolyltriazole
Phosphoric acid, isodecyl diphenyl ester
Isocyanic acid, trimethylcyclohexyl ester
aka: Isocyanic acid, trinethylhexanethylene ester
Hexane, 1, 6-diisocyanato-2 f 2, 4 (or 2,4,4)-
trimethyl-
Naphthalene, heptachloro-
2-Propenoic acid, 2 -methyl-, octadecyl ester
Pentabromodiphenyl oxide
aka: Pentabromodiphenyl ether
Octabromodiphenyl oxide
aka: Octabromodiphenyl ether
2 , 4-Imidazolidinedione, 5, 5-dimethyl-3-[2-
( oxirany Imethoxy ) propyl ] -1- ( oxiranylmethy 1 ) -
N, N'-Ethylenebis (tetrabromophthalimide)
aka: IH-Isoindole-l, 3 (2H) -dione, 2,2' -(1,2-
ethanediy 1 ) bis [ 4 , 5 , 6 , 7-tetrabromo-
Phosphoric acid, 1,2-ethanediyl tetrakis
(2-chloroethyl) ester
s5
dl
dl
P21
d25
Pi
dl
c2
d20
r2
a5
dl
Pi
t31
d27
P23
t31
d27
P23
dl
P23
d27
p20
d24
33791-58-1
34274-30-1
34364-42-6
2-Propenoic acid, 3a,4,5,6,7,7a-hexahydro-4,7-
 methano-lH-indenyl ester

Phosphonic acid, [l,2-ethanediylbis[nitrilobis
 (methylene)]] tetrakis-, potassium salt

Phosphoric acid, (l-methyl-l-phenylethyl)phenyl
 diphenyl ester
ai:
di
                              61
                                      (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES


34! 4-8
J5243-89-1
36355-01-8
37853-59-1
374.53-61-5
38304-52-8
38565-52-5

38661-72-2
38954-75-5
39 11-7
39817-09-9
41291-34-3
42389-30-0
51363-64-5
53469-21-9
54208-63-8
LISTED BY CAS NUMBER

Propanol , ( 2-methoxynethylethoxy ) -
aka: Dipropylene glycol nonomethyl ether
oxirane , [ ( 1 , 2-dibronopropoxy ) methyl ] -
Hexabroaobiphenyl (unspecified location of bromines)
Benzene, 1, !'-[!, 2-ethanediy Ibis (oxy) ] bis ( 2,4,6-
tribrono-
aka: l,2-Bis(tribromophenojcy) ethane
Bismethyl ether of tetrabromobisphenol A
2 , 4-Inidazolidenedione , 3 , 3 ' - [ 2- ( oxirany Imethoxy ) -1 ,
3-propanediyl ] bis [ 5 , 5-dimethyl-l- (oxiranylmethyl) -
tridecaf luoroheptyl) -
Cyelohexane , 1 , 3 -bis ( isocyanat methyl) -
Oxirane , [ ( tetradecy loxy ) methyl ] -
1,3-Benzenediaaine, 4-methoxy-, sulfate (1:1)
aka: 2,4-Diaainoanisole sulfate
Oxirane, 2 , 2 '-[methylenebis (phenyleneoxymethylene) ]
bis-
aka: 2, 2'- (Methylenebis (phenyleneoxymethylene) ]
bisoxirane
Ethylene (5 , 6-dibrononorbomane-2 , 3-dicarboxioide)
aka: 4 , 7-Methano-lK-isoindole-l , 3 (2H) -dione, 2,2'-
( 1 , 2-ethanediyl ) bis ( 5 f 6-dibromohexahydro-
1 , 2-Benzenedianine, 5-chloro-3-nitro-
Phosphoric acid, diisodecyl phenyl ester
PCBs — Aroclor 1242
Oxirane. 2.2'-rmethvlenebisf 2. 1-

RtlT.F CODE
p21
d25
dl
s5
t31
Pi
d27
P23
t31
dl
r2
dl
C2
d20
P2
dl
P3
d3
sr313
dl
p23
d27
r2
P3
d3
Pi
dl
srli:
dl
                  62
(06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER

54849-38-6

55205-38-4
56803-37-3

56827-95-3
57011-27-5

57137-10-7

57344-01-1

57344-02-2

60501-41-9
61262-53-1

61386-02-5

61578-04-9

61702-81-6
61788-33-8

61788-76-9
61789-36-4

61789-51-3
CHEMICAL NAME	
 phenyleneoxymethylene)]bis-
RULE CODE
Monomethyltin tris(isooctyl) mercaptoaeetate           r2
 aka:  Acetic acid, 2,2',2"-[(methylstannylidyne)tris  p7
        (thio)]tris-f triisooctyl ester                d2
Tetrabroaobisphenol A diacrylate                       t31
Phosphoric acid,  (l,l-dimethylethyl)phenyl diphenyl    pi
 ester                                                 dl
1-Hexadecanol, phosphate (3:1)                          c2
Phosphonic acid,  [l,2-ethanediylbis[nitrilobis         a!2
 (nethylene) ] ] tetrakis-, ammonium salt
Tribrominated polystyrene                              p23
                                                       d27
Poly(oxy-l,2-ethanediyl), alpha,alpha'-                c2
 [(octyloxy)phosphinylidene]bis[omega-hydroxy-
Poly(oxy-l,2-ethanediyl), alpha-[bis(octyloxy)         c2
 phosphinyl]-omega-hydroxy-
Oxirane, [9-Octadecenyloxy)methyl]-,(Z)-               dl
Ethylenebis(pentabromophenoxide)                       p2 3
 aka: Benzene, 1,!'-[!,2-ethanediyIbis(oxy)]bis        d27
       [2,3,4,5,6-pentabromo-
Benzoic acid, 3,3'-methylenebis[6-amino-,. di-2-        s28
 propenyl ester
Oxirane, [[4-(l-methyl-l-phenylethyl)phenoxy]          dl
 methyl]-
1,2-Benzenedicarboxylic acid, hexyl isodecyl ester     dl
Terphenyl, chlorinated                                 r2
 aka:  Polychlorinated p-terphenyl                     a4
                                                       dl
Alkanes, chloro-                                       dl
Naphthenic acids, calcium salts                        p4
 aka:  Calcium naphthenate                             d4
Naphthenic acids, cobalt salts                         p4
 aka:  Cobalt naphthenate                              d4
                              63
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES-(CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
C 	 "TIBER
6! 14-5
61886-60-0
62654-17-5
63449-39-8
64131-07-3
64131-08-4
64131-09-5
64131-10-8
64131-18-6
64502-13-2
65a<»0-44-9
66108-37-0
66422-95-5
67801-06-3
67860-04-2
CHEMICAL NAME Rl
Naphthenic acids, lead salts
aJca: Lead naphthenate
1,2-Benzenedicarboxylic acid, isodecyl tridecyl
ester
1,4-Benzenediaaine, ethanedioate (1:1)
Paraffin waxes and hydrocarbon waxes, chloro
l-Hexacosanol, phosphate (3:1)
1-Tetracosanol, phosphate (3:1)
1-Docosanol, phosphate (3:1)
l-Eicosanol , phosphate (3:1)
1-Octacosanol, phosphate (3:1)
Poly (oxy-l, 2-ethanediyl) , alpha, alpha' , alpha" -
phosphinylidynetris ( omega-hydroxy-
Phenol, 2,4-diamino-6-methyl-, hydroehloride
Phosphoric acid, 2 , 2-bis (broaoaethyl) -3-chloropropyl
bis [ 2-chloro-l- ( chloronethyl ) ethyl ] ester
Ethanol, 2-(2,4-dianinophenoxy)-, dihydrochloride
1,3-Benzenediamine, 4-ethoxy-, dihydrochloride
Oxirane,. heptadecyl-
7LE CODE
P4
d4
dl
P3
d3
dl
C2
C2
c2
c2
c2
c2
r2
P3
d3
Pi
r2
P3
d3
r2
P3
d3
r2
dl
67924-23-6
67969-67-9
Cobaltate(6-), [[[l,2-ethanediylbis[nitrilobis         a!2
 (methylene)]]tetrakis[phosphonato]](8-)]-,
 pentapotassiua hydrogen, (QC-6-21)-

Cobaltate(6-), [[[l,2-ethanediylbis[nitrilobis         al2
 (methylene)]]tetrakis[phosphonato]](8-)-N,N',O,O",
 Q,,,,Q,,,,,,1_i pentasodium hydrogen, (OC-6-21)-
                             64
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER
CAS NUMBER   CHEMICAL NAME
                                                    RULE CODE
67989-89-3
67989-89-3
Cuprate(6-), [[[1,2-ethanediyIbis[nitrilobis
 (methylene)]]tetrafcis[phosphonato]](8-)]-,
 pentapotassiua hydrogen, (OC-6-21)-

Cuprata (6-), [[[1,2-cthanediylbis[nitrilobis(methyl
 ene) ] ] tetrakis [ phosphonato ] ] (8 -) ] -, pentapotass iua h
 ydrogen,  (OC-6-21)-
68015-98-5   1,3-Benzenediamine, 4-ethoxy-, sulfate (1:1)
68025-39-8




68081-84-5



68122-86-1




68153-35-5




68188-98-8



68239-80-5
Cobaltate(e-), [[[1,2-ethanediyIbis[nitrilobis
 (methylene) ] ] tetralcis [phosphonato] ] (6-)-N,N' ,O,O"',
 Q*ff»fo"»»*»]-f pentaaaaonium hydrogen, (OC-6-21)-

Oxirane, aono[(C (10-16)-alkyloxy)methyl]
 derivatives

laidazoliua compounds, 4,5-dihydro-l-methyl-2-
 nortallow alkyl-l-(2-tallov aaidoethyl), methyl
 sulfates

Ethanaainiua, 2-amino-N-(2-aminoethyl)-N-(2-
 hydroxyethyl)-N-methyl-, N,N'-ditallow acyl
 derivatives, methyl sulfates (salts)

Phosphonie acid, [1,2-ethanediyIbis[nitrilobis
 (methylene) ] ] tetralcis-, tetrapotassium salt

1,3-Benzenediamine, 4-chloro-, sulfate  (1:1)
 aka:  a-Phenylenediaaine, 4-chloro-, sulfate
68239-82-7   1,2-Benzenediaaine, 4-nitro-, sulfate  (1:1)
68239-83-8   1,4-Benzenediamine,  2-nitro-, sulfate  (1:1)
68298-46-4   7-Benzofuranaaine,  2,3-dihydro-2,2-diaethyl-
68309-98-8
Cadaate(6-),  [[[1,2-ethanediylbis[nitrilobis
 (methylene)]]tetrakis[phosphonato]](8-)]-,
 pentapotassium hydrogen,  (OC-6-21)-
a!2
al2
r2
P3
d3

al2
dl
pl9
d23
pl9
d23
al2


r2
P3
d3

r2
P3
d3

r2
P3
d3

r2

d5

a.
                              65
                                       (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES. (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY CAS NUMBER
C; MBER
6C 88-8
68389-89-9
68410-69-5
68413-04-7
68459-98-3
68515-44-6
6f 45-7
683X9-47-9
68515-49-1
68515-50-4
68517-02-2
68554-06-3
68609-96-1
68609-97-2
68611-64-3
CHEMICAL NAME RULE CODE
Poly(oxy-l,2-ethanediyl) , alpha-[2-[bis(2-
aninoethy 1 ) methy laoaonio ] ethyl ] -omega-hydroxy- , N ,
N'-dicoco acyl derivatives, methyl sul fates (salts)
Poly(oxy-l, 2-ethanediyl) , alpha- [2- [bis (2-
aainoethy 1 ) methylammonio ] ethyl ] -omega-hydroxy- , N ,
N'-bis(hydrogenated tallow acyl) derivatives, methyl
sul fates (salts)
Poly (oxy-1, 2-ethanediyl) , alpha-[2-[bis(2-
aminoethy 1 ) methylammonio ] ethyl ] -omega-hydroxy- , N ,
N'-ditallov acyl derivatives, methyl sul fates
(salts)
Poly[oxy(methyl-l, 2-ethanediyl) ] , alpha-[2-[bis(2-
aminoethy 1 ) methylammonio ] methylethy 1 ] -omega-
hydroxy-, N,N'-ditallow acyl derivatives, methyl
sulfates (salts)
1,2-Benzenediamine, 4-chloro-, sul fate (1:1)
Diheptyl phthalate (branched and linear isomers)
Dinonyl phthalate (branched and linear isomers)
Oitridecyl phthalate (mixed isomers)
Diisodecyl phthalate (mixed isomers)
Dihexyl phthalate (mixed isomers)
oxirane , 2 , 2 ' , 2 "- [ propy 1 idynetris (4,1-
phenyleneoxymethylene) ]tris-
Poly (oxy-1, 2-ethanediyl) , alpha- [3- [bis (2-
aminoethyl) methylammonio] -2 -hydroxypropyl ] -omega-
hydroxy-, N-coco acyl derivatives, methyl sulfates
(salts)
Oxirane, mono[C ( 8-10 )-alkyloxy) methyl] derivatives
Oxirane, mono[(C ( 12-14) -alky loxy) methyl]
derivatives
Urea, reaction products with formaldehyde
pl9
d23
d23
pl9
pl9
d23
P19
d23
r2
P3
d3
t44
t44
t44
t44
t44
dl
P19
d23
dl
dl
pi:
d:
                  66
(06/30/90)
-------
            CHEMICAL ABSTRACT  SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                            LISTED eft CAS NUMBER
CAS NUMBER
68901-17-7
68920-70-7
68958-86-1
CHEMICAL NAME
Phospnonic acid, [1,2-ethanediy Ibis [nitrilobis
(methylene) ] ]tetrakis-, octaaaaoniua salt
Alkanes, C (6-18), chloro-
HicXelate(6-) , [ [ [1,2-ethanediy Ibis [nitrilobis
RULE CODE
al2
dl
al2
68958-87-2




68958-88-3




68959-23-9



68966-84-7




68987-80-4

69009-90-1




69155-42-6



69943-75-5



70776-03-3




70914-09-9
71033-08-4
  (methylene) ] ]tetrakis[phosphonato] ] (8-) ]-,
 pentaaaaoni.ua hydrogen, (OC-6-21)-

Nickal ate(6-), [[[1,2-ethanediylbis[nitrilobis
  (methylene)]]tetrakis[phosphonato]](8-)]-,
 pentapotassi.ua hydrogen (OC-6-21)-

Nickelate(6-), [[[1,2-ethanediyIbis [nitrilobis
  (methylene)]]tetrakis[phosphonato]](8-)]-,
 pentasodiua hydrogen (OC-6-21)-

Oxirane, 2,2',2"-[1,2,6-hexanetriy 1 tris
  (oxynethylene)]tris-

1,3-Benzenediaaine, ar-ethyl-ar-methyl-
1,1 -Biphenyl, bis(l-aethylethyl)-
 aka:  Diisopropyl biphenyl
Tetrasiloxane, 1,1,1,3,5,7,7,7-octaaethyl-3,5-bis
 [3-(oxiranylaethoxy)propyl]-

Poly(oxy-1,2-ethanediy1), alpha-(4-(oxiranylaethoxy)
 benzoyl]-gaaaa-[[4-(oxiranylaethoxy)benzoy1]oxy]-

Naphthalene, chloro derivatives
Poly(oxy-l,2-ethanediyl), alpha-[2-[bis(2-
 aainoethyl)aethylaaaonio]ethyl]-oaega-hydroxy-,  N,
 N'-di-C (14-18) acyl derivatives, methyl sulfates
 (salts)

Oxirane, 2,2'-[(l-oethylethylidene)bis[4,1-
 phenyleneoxy[l-(butoxyaethyl)-2,1-ethanediyl]
 oxyaethylene]]bis-
al2
a!2
dl
r2
P3
d3
Oxirane, aono[C (6-12)-alkyloxy)aethy1] derivatives    dl
r2
p6
d8

dl
dl
r2
a5
dl

P19
d23
dl
71808-64-5   Silane,(3-chloropropyl)di=ethoxy[3-(oxiranylBethoxy)   dl
                              67
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER

                                                                 RULE CODE"
73070-47-0



73980-60-8

74049-24-4



75790-84-0



75790-87-3



79771-08-7


79771-09-8

84852-15-3
85712-26-1



85712-27-2



94148-67-1



100545-50-4


111381-89-6



111381-90-9



111381-91-0
Oxirane, 2,2'-[(l-methylethylidene)bis[4,1-            dl
 phenyleneoxy-3,l-propanediyloxy-4,1-phenylene(1-
 methylethylidene)-4,1-phenyleneoxymethylene]]bis-

Poly(oxy-1,2-ethanediyl), alpha,alpha',alpha"-         c2
 phosphinylidynetris[omega-(tridecyloxy)-

Diphenyl-2,4,6-trimethylbenzoyl phosphine-oxide        s48

Poly(oxy-1,2-ethanediyl), alpha,alpha'-                c2
 (methoxyphosphinylidene)bis[omega-hydroxy-

Benzene, 2-isocyanato-4-((4-isocyanatophenyl)methyl]   c2
 -1-methyl-                                            d20

Benzene, l-isocyanato-2-[(4-isocyanatophenyl)thio]-    c2
                                                       d20

Isopropylamine, distillation residues                  sl3

Ethylamine, distillation residues                      s!3

4-Nonylphenol, branched*                               t49*
  * - Chemical Abstracts Service does not consider
      this registry number (CAS No.) to represent a
      unique chemical substance; therefore, this is
      denoted by an asterisk (*).
 aka: para-branched C9-Alkylphenols

Potassium N,N-bis(hydroxyethyl) cocoamine oxide        s!2
 phosphate

Potassium N,N-bis(hydroxyethyl) tallovamine oxide      s!2
 phosphate

Benzenamine, 4,4'-[[l,l'-biphenyl]-2,5-diylbis(oxy)]   s58
 bis-

Decanamine, N-decyl-N-methyl-N-oxide                   s47

Di(heptyl, nonyl) phthalate (branched and linear       t44
  isomers)

Di(heptyl, undecyl) phthalate  (branched and linear     t44
  isomers)

Di(nonyl, undecyl) phthalate (branched and linear      t44
  isomers)
                             68
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY CAS NUMBER

CAS NUMBER   CHEMICAL NAME                                       RULE CODE
                             69                     (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY PMN NUMBER
PT" ""TMBER
8 \
80-290
81-69
CHEMICAL NAME
Isopropylamine, distillation residues *
Ethylamine, distillation residues *
Benzoehenonetetracarboxvlic acid dimethyl ester.
RULE CODE
313
313
323
              reaction product with nethylenedianiline and
              substituted pyridine.
81-125       Benzophenonetetracarboxylic acid dimethyl ester,       s24
              reaction product with methylenedianiline «nd
              alleylenediamine; and benzophenonetetracarboxylic
              acid dimethyl ester, reaction product with
              methylenedianiline, allcylenediamine and substituted
              pyridine .
82-326       Substituted methylpyridine *                           s!6
82-400       Potassium N,N-bis(hydroxyethyl) cocoamine oxide        s!2
              phosphate
82-409       Potassium N,N-bis(hydroxyethyl).tallovamine oxide      sl2
              phosphate
82-438       Benzole acid, 3,3'-methylenebis-[6-amino-di-2-         s28
              propenyl] ester
a:            Derivative of tetrachloroethylene *                    s!9
8^-^j        Sustituted 2-phenoxypyridine * .                        sis
83-24        Substituted methylpyridine *                           sis
83-49        Substituted methylpyridine *                           si 5
83-75        Substituted 2-phenoxypyridine *                        sir
83-105       1,2-Benzenediamine, 4-ethoxy-, sulfate                 si;
83-237       Substituted methylpyridine *                           =
83-255       Dicarboxylic acid monoester *
83-272       Substituted methylpyridine *
83-330       Substituted 2-phenoxypyridine *
83-370       8-Acetyl-3-dodecyl-7,7,9,9-tetramethyl-l-,3,-8-
              triaza-spiro-[4,5]-decane-2,4-dione
83-394       Substituted polyglycidyl benzenamine *

                             70                     (06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY PMN NUMBER
PMN NUMBER
83-769
83-817
83-818
83-822
83-906
83-908
83-909
83-910
83-1005
83-1023
83-1062
83-1085
84-7
84-27
84-105
84-106
84-107
84-176
84-180
84-181
84-182
84-183
84-184
CHEMICAL NAME RULE CODE
Substituted bronothiophene *
[ (Dinitrophenyl) azo] -[2 , 4-diamino-5-
Methoxybenzene derivatives
Disubstituted dianino anisole *
Brominated arylalkyl ether *
Ethylated aminophenol *
Amino phenol *
Aniline ether *
Triethanolamine salt of tricarboxylic acid *
Alkylaryl phosphine *
Tricarboxylic acid *
Halogenated-N- ( 2-propenyl ) -N- [ substituted phenyl ]
acetamide
N , N , N ' , N ' -Tetrakis ( oxiranylmethyl ) -1 , 3 -
cyclohexanedimethananj.ne or N,N,N',N'-Tetraglycidyl-
1 , 3 -bisaainomethylcyclohexane
Alkyl glycol ether acrylic acid derivative *
Substituted tetrafluoroalkane *
Disubstituted tetrafluoroalkane *
Disubstituted tetrafluoroalkane *
Alkanetriol dimethacrylate, substituted *
Polyalkylene glycol monomethacrylate, substituted *
Polyalkyl-alkane diol nonoacrylate, substituted *
Alkanetriol polyalkylene glycol ester aery late,
substituted *
Alkylene glycol monomethacrylate, substituted *
Polyalkylalkanediol monomethacrvlate. substituted *
a26
s29
s30
s31
s25
s25
325
325
X3
S27
X3
S37
S41
S32
S35
S35
S35
S33
S34
S34
S34
534
s; •;
                  71
(06/30/90)
-------
CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                LISTED BY PMN NUMBER
PMN NUMBER
8'
84-310
84-341
84-342
84-343
84-344
84-417
84-482
84 1
8'
84-660
84-704
84-820
84-824
84-913
84-954
84-963
84-1007
CHEMICAL NAME RUL
Poly (oxy-l, 4-butanediyl) -alpha- (l-oxo-2-propenyl) -
gamma- [ ( l-oxo-2-propenyl ) -oxy ] - *
Triethanolamine salt of a substituted organic acid
2-Oxepanone, honopolyner, ester with 3-hydroxy-2,2-
dimethylpropanoic acid (2:1), di-2-propenoate;
2-Oxepanone, homopolymer, 2-propenoate, (tetrahydro-
2-furanyl) methyl ester;
2-Oxepanone, homopolymer, 2-propenoate, ester with
2 , 2 ' - [ oxybis (methylene) ] bis- [ 2- (hydroxymethyl ) -1 , 3-
propanediol ] ;
2-Propenoic acid, [ 2- [ 1 , 1 -dimethyl -2- [ ( l-oxo-2-
propenyl) oxy]ethyl J-5-ethyl-l, 3 -dioxan-5-yl] methyl
ester.
Methylphenol, bis (substituted alkyl)- *
Urea, condensate with poly[oxy(methyl-l,2-
ethanediyl ) ] -alpha- ( 2-aminomethylethyl ) -mu- (2-
aminoethylethoxy) (generic name)
Mixed mono* and diamides of an organic acid
Sodium salt of an alkylated, suj/fonated aromatic
(generic name)
Substituted benzenes, halogenated *

Phosphonium salt (generic name)
Brominated aromatic compound (generic name)
N,N'-Bis(2-(2-(3-alkyl)thiazoline) vinyl) -1,4-
phenylenediamine methyl sulfate, double salt
(generic name)
Substituted aromatic (generic name)
6-Nitro-2 (3H) -benzoxazolone
3-Alkyl-2-(2-anilino)vinylthiazolinium salt (generic
E CODE
339
X4
338
338
338
338
S3 6
359
x5
S59
342
342
360
S59
359
359
S59
S59
   name)
                  72                     (06/30/90)
-------
            CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS  & CHEMICAL NAMES
                            LISTED BY PMN NUMBER
PMN NUMBER   CHEMICAL NAME
84-1042
84-1054
84-1056
84-1079
85-335

85-336
85-337
85-367
85-368
85-369
85-433
85-605
85-680
85-730
85-929
85-932
85-933
85-1331
86-83
Methylammoniun, N-nethyldithiocarbamate
Alkyl sulfonic acid, ammonium salt *

ADcylated diphenyl oxide (generic name)
RULE CODE
    S40
    843
    343
    360
    S58
Benzenaaine, 4,4'-[[1,1'-bipheny1]-2,5-diyIbis(oxy)]
 bis-
A reaction mixture consisting of 1,2,4,5-              s58
 benzenetetracarboxylic acid, 1,4-diethyl ester
 compound with 4,4'-[[l,l'-biphenyl]-2,5-diyIbis(oxy)
 ]bis[benzeneamine] (1:1) and 1,2,4,5-
 benzenetetracarboxylic acid, 1,5-diethyl ester
 compound with 4,4'-[[l,1'-bipheny1]-2,5-diyIbis(oxy)
 ]bis[benzeneamine] (1:1)
1,2,4,5-benzenetetracarboxylic acid, 1,4-diethyl       s58
 ester, compound with 4,4'-[[l,l'-biphenyl]-2,5-
 diyIbis(oxy)]bis[benzeneamine] (1:1), polymer with
 4,4'-[[1,1'-biphenyl]-2,5-diyIbis(oxy)]bis[
 benzeneamine]-!,5-diethyl-l,2,4,5-
 benzenetetracarboxylate (1:1)
Haloalkyl substituted cyclic ethers (generic name)     s60
Haloalkyl substituted cyclic ethers (generic name)     s60
Haloalkyl substituted cyclic ethers (generic name)     s60
1-Propanol, 3-mercapto-                                s53
Trisubstituted phenol (generic name)                   s60
1,1-Dimethylpropyl peroxyester (generic name)          s60
Substituted phosphate ester  (generic name)             s59
1,3-Benzenediamine, 4-(1,l-Dimethylethyl)-ar-methyl    s52
Disubstituted alkyl triazines (generic name)           s59
Oisubstituted alkyl triazines (generic name)           s59
Naphthalene, l,2,3,4-tetrahydro(l-phenylethyl)         s60
                                                       S44
                              73
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES (CAS) NUMBERS & CHEMICAL NAMES
                           LISTED BY PMN NUMBER

36J
36-501
36-502
36-503
86-542
86-562
86-628
86-1043
86-1044
86-1153
86-1252
86-1322
86-1489
86-1493
87-304
87-502
87-1265
CHEMICAL NAME RULE
Tetraglycidylaaines (generic name)
Aromatic diaaines (generic naae)
Tetraglycidylaaines (generic naae)
Aromatic diaaines (generic naae)
Ethanol, 2-aaino-, compound with N-hydroxy-N-
nitrosobenzenaaine (1:1)
Perfluoroalkyl epoxide (generic name)
Dimer acids, polymer with polyalkylene glycol,
bisphenol A - diglycidyl ether, and alkylenepolyols
polyglycidyl ethers (generic name)
Monosubstituted alkoxyaminotrazines (generic name)
Monosubstituted alkoxyaminotrazines (generic name)
1,2,4,5-Benzenetetracarboxylic acid, 1,4-diethyl
ester, compound with 4,4'-[[l,l'-biphenyl]-2,5-
diy Ibis ( oxy )] bis (benzeneamine] (1:1), polymer with
4,4'-[[l,l'-biphenyl]-2,5-diylbis(oxy)]bis[
benzeneamine] -1 , 5-diethyl-l , 2,4,5-
benzenetetracarboxylate (1:1), reaction products
with phthalic anhydride
Boric acid, alkyl and substituted alkyl esters
(generic name)
Mixture of 1,3-Benzenediamine, 2 (or 4)-* methyl-4,6
(or 2,6)-bis(methylthio)-
Alkylphenoxypolyalkoxyamine (generic name)
Substituted alkyl peroxyhexane carboxylate (mixed
isomers) (generic name)
Nitrothiophene carboxylic acid, ethyl ester, bis[[[[
(substituted) ]aaino] alky lphenyl]azo] (generic name)
Dialkanylaaide (generic name)
2-Naphthalenecarboxamide-N-aryl-3-hydroxy-4-arylazo
CODE
859
860
859
860
845
859
s60
860
860
858
860
851
859
860
s60
859
S60
87-1456
 (generic name)

Polyamine ureaformaldehyde condensate  (generic name)   s60
                             74
                                       (06/30/90)
-------
           CHEMICAL ABSTRACT SERVICES  (CAS) NUMBERS & CHEMICAL NAMES
                            LISTED BY PMN NUMBER

PMN NUMBER   CHEMICAL NAME                                      RULE CODE
88-63Substituted  thiazino hydrazine salt  (generic name)s60

88-854       Polymer  of alkenoie acid, substituted alkylacrylate,   s59.
              sodium  salt (generic name)

88-1658      Polymer  of alkanepolyol and                            s59
              polyalkylpolyisocyanatocarbomonocycle, acetone oxime
              -blocked  (generic name)

89-279       Formaldehyde,  polymer with bisphenol A and             s59
              substituted phenol (generic name)

99-292       Carboxy  alkyl  silyl salt  (generic name)                s59

89-303       Urea,  (hexahydro-6-methyl-2-oxo-4-pyrimidinyl)-        s59

89-448       Alkanepolyol phosphate ester (generic name)            s57

89-506       Alkylated diarylamine, sulfurized (generic name)       s59

89-596       Alkylene glycol terephthalate and substituted          s59
              benzoate esters (generic name)

89-650       Substituted  ethylene diamine, methyl sulfate           s57
              quatemized (generic name)

89-653       Adipic acid, polymer with 1,4-Cyclohexanedimethanol,   s57
              dipropylene glycol, alkanepolyol, substituted
              alkanolamines,  and carbomonocyclic dicarboxylic acid
              (generic name)

89-703       Reaction products of secondary alkyl amines with a     s57
              substituted benzenesulfonic acid and sulfuric acid
              (generic name)

89-755       Reaction products of secondary alkyl amines with a     s57
              substituted benzenesulfonic acid and sulfuric acid
              (generic name)

89-756       Reaction products of secondary alkyl amines with a     s57
              substituted benzenesulfonic acid and sulfuric acid
              (generic name)

89-770       Coconut  oil, reaction products with tetrahydroxy       s5"-
              branched alkane esters of trisubstituted benzene
              propanoic acid (generic name)
                              75                     (06/30/90)
-------
                CHEMICALS ON REPORTING RULES  (CORR) DATABASE
               CATEGORIES AND CHEMICALS IN ALPHABETICAL ORDER
**********
            CATEGORY NAME AND CHEMICALS OR MIXTURES TO
             WHICH A CAS NUMBER HAS NOT BEEN ASSIGNED
Allcyl epoxides—                                        r2
  including all noncyclic aliphatic hydrocarbons with   dl
  one or more epoxy functional groups.  Representative
  alJcyl epoxides are listed by CAS registry number.
  The 8(d) reporting period for this category, listed
  in 40 CFR 716.120(c), has been terainated.  Certain
  substances within this category have been
  transferred to the individual listing (40 CFR
  716.120(a)) and their original sunset dates remain
  in effect.
**********
Alkyl phthalates—
  all allcyl esters of 1,2-benzenedicarboxylic acid
  (ortho-phthalic acid).  Representative allcyl
  phthalates are listed by CAS registry number.
dl
**********
Allcyl phthalates (confidential) —
  all allcyl esters of 1,2-benzenedicarboxylic acid
  (ortho-phthalic acid).  Confidential category
  members only.
P2
     I*****  Alkylamine tetrachlorophenate—
                                                        t31
**********
Alkyltin compounds-
  Representative allcyl tin compounds are listed by CAS
  registry number.  The 8(d) reporting period for this
  category, listed in 40 CFR 716.120(c), has been
  terminated.  Certain substances within this category
  have been transferred to the individual  listing
  (40 CFR 716.120(a)) and their original sunset dates
  remain in effect.
r2
d2
**********
Aniline and chloro-,bromo-, and/or nitroanilines—
  Representative chemicals are listed by CAS  registry
  number..
dl
**********  Antimony compounds-
                                                         sr:: 3
**********
Aromatic C9 fraction—
  from petroleum refining.
t;
                             76
                                        (06/30/90)
-------
                CHEMICALS ON REPORTING RULES (CORR) DATABASE
              - CATEGORIES AND CHEMICALS IN ALPHABETICAL ORDER
            CATEGORY NAME AND CHEMICALS OR MIXTURES TO
             WHICH A CAS NUMBER HAS NOT BEEN ASSIGNED
                                                         RULE
                                                         CODE
**********  Arsenic compounds-
**********
Aryl phosphates--
  phosphate esters of phenol or of alkyl-substituted
  phenols.  Triaryl and mixed alkyl and aryl esters
  are included but trialkyl esters are excluded.
  Representative aryl phosphates, are listed by CAS
  registry number.
sr313


dl
**********
Aryl phosphates  (Confidential) —
  phosphate esters of phenol or of alkyl-substituted
  phenols.  Triaryl and mixed alkyl and aryl esters
  are included but trialkyl esters are excluded.
  Confidential category members only.
                                                                    P2
**********
            Asbestos—                                              x6
              asbestiform varieties of chrysotile (serpentine);     sr3i:
              crocidolite (riebeckite); amosite (cummingtonite-     a3
              grunerite); anthophyllite; tremolite; and             dl
              actinolite.
**********  Barium compounds—
                                                        srllO
                                                        sr313
**********  Beryllium compounds—
**********
Bisazobiphenyl dyes-
  derived from benzidine and its congeners,
  ortho-toluidine  (dimethyIbenzidine) and dianisidine
  (dimethoxybenzidine).  Representative bisazophenyl
  dyes are listed by CAS registry number.
sr313


dl
**********  Boron compounds—
**********  Cadmium compounds—
**********
Chlorinated benzenes-
  mono, di-, tri-, tetra- and penta-.  Representative
  chlorinated benzenes are listed by CAS registry
srllO


sr313


dl
                             77
                                        (06/30/90)
-------
                CHEMICALS ON REPORTING RULES  (CORK) DATABASE
               CATEGORIES AND CHEMICALS IN ALPHABETICAL ORDER

            CATEGORY NAME AND CHEMICALS OR MIXTURES TO               RULE
^^           WHICH A CAS NUMBER HAS NOT BEEN ASSIGNED                CODE
              number..


**********  chlorinated naphthalenes—                              r2
              chlorinated derivatives of naphthalene (empirical     as
              formula) C (10)H (x)Cl (y), where x + y » 8.          dl
              Representative chlorinated naphthalenes are listed
              by CAS registry number.  The 8(d) reporting period
              for this category, listed in 40 CFR 716.120(c), has
              bear terminated.  Certain substances within this
              category have been transferred to the individual
              listing (40 CFR 716.120(a)) and their original
              sunset dates remain in effect.


**********  chlorinated paraffins—                                 dl
              chlorinated paraffin oils and chlorinated paraffin
              waxes, with chlorine content of 35 percent through
              70 percent by- weight.  Representative chlorinated
              paraffins are listed by CAS registry number.


**********  chlorodibenzodioxins—                                  srlio


*     ****  chlorodibenzofurans—                                   srlio


**********  chlorophenols—                                         sr313-


**********  chromium compounds—                                    sr313


**********  cobalt compounds—                                      srlio
                                                                    sr313


**********  commercial hexane—                                     t26
              for purposes of this rule, is a product obtained
              from crude oil, natural gas liquids or petroleum
              refinery processing which consists primarily  of six-
              carbon alkanes or cycloalfcanes and contains at least
              50 liquid volume percent n-hexane  (CAS No. 110-54-3)
              and at least 5 liquid volume percent
              methylcyclopentane  (MCP; CAS No. 96-37-7).


**********  copper compounds—                                      sr3i3*


                             78                     (06/30/90)
-------
                 CHEMICALS ON REPORTING RULES (CORR)  DATABASE
                CATEGORIES AND CHEMICALS IN ALPHABETICAL ORDER
             CATEGORY NAME AND CHEMICALS OR MIXTURES TO               RULE
	WHICH A CAS NUMBER HAS NOT BEEN ASSIGNED	CODE


 **********  cyanide compounds—                                     sr313


 **********  Ethyltoluenes—                                         r2
               This category consists of ethyltoluene (mixed         d3
               isomers)  and the ortho-,  meta-,  and para-isomers.
               Representative ethyltoluenes are listed by CAS
               registry number.  The 8(d)  reporting period for this
               category,  listed in 40 CFR 716.120(c),  has been
               terminated.  Certain substances within this category
               have been transferred to  the individual listing
               (40 CFR 716.120(a))  and their original sunset dates
               remain in effect.


 **********  Fluoroalkenes—                                         d3
               this category is defined  as fluoroalkenes of the
               general formula: C (n)H (2n-x)F (x), where n equals
               1 to 6.  Representative fluoroalkenes are listed by
               CAS registry number.


 **********  Fully halogenated chlorofluoroalkane—                  x2


 **********  Glycidol (oxiranemethanol)  £ derivatives (confident)— .p2
               C (2)H <3)0-CH (2)0-R, where R is an alkyl, alkenyl,
               alkynylf  aryl, or acyl group.  Any substituent or
               functional group may be present on the alkyl, etc.
               groups.  Confidential category members only.


 **********  Glycidol (oxiranemethanol)  and its derivatives—        d:
               C (2)H (3)O-CH (2)O-R, where R is an alkyl, alkenyl,
               alkynyl,  aryl, or acyl group.  Any substituent or
               functional group may be present on the alkyl, etc.
               groups.  Representative derivatives are listed by
               CAS registry number.


 **********  Glycol ethers—


 **********  Halogenated alkyl epoxides—
               halogenated noncyclic aliphatic hydrocarbons with
               one or more epoxy functional groups.  Representative
               halogenated alkyl epoxides are listed by CAS


                              79                    (06/30/90)
-------
                CHEMICALS ON REPORTING RULES (CORR) DATABASE
               CATEGORIES AND CHEMICALS IN ALPHABETICAL ORDER

            CATEGORY NAME AND CHEMICALS OR MIXTURES TO
             WHICH A CAS NUMBER HAS NOT BEEN ASSIGNED
                                                         RULE
                                                         CODE
              registry number.  The 8(d) reporting period for this
              category, listed in 40 CFR 716.120(c), has been
              terminated.  Certain substances within this category
              have been transferred to the individual listing
              (40 CFR 716.120(a)) and their original sunset dates
              remain in effect.
**********  Lead compounds—
                                                        sr313
**********  Manganese compounds—
**********  Mercury compounds—
                                                        sr313


                                                        sr313
**********  Nickel compounds—
**********
Phenylenediamine—
  this category is defined as all nitrogen-
  unsubstituted phenylenediamines and their salts with
  zero to two substituents on the ring selected from
  the same or different members of the group of halo,
  nitro, hydroxy, hydroxy-lower alkoxy, lower-alkyi,
  and lower alkoxy. For this purpose, the term "lower"
  is defined as a group containing between one and
  four carbons. The reporting period for certain
  individual members of the category will be
  terminated. This is represented by the rule code r2.
sr313


d3
**********
Polybrominated biphenyls—
  brominated biphenyl molecules having the molecular
  formula C (12)H (x)Br (y), where x + y » 10 and y
  ranges from 1 to 10.
**********
Polychlorinated biphenyls—
  any chemical substance that is limited to the
  biphenyl molecule that has been chlorinated to
  varying degrees, or any combination of substances
  which contains such substances.
**********  Radium compounds—
**********  Radon compounds—
                             80
                                        (06/30/90)
-------
               • CHEMICALS ON REPORTING RULES (CORR) DATABASE
               CATEGORIES AND CHEMICALS IN ALPHABETICAL ORDER
            CATEGORY NAME AND CHEMICALS OR MIXTURES TO
             WHICH A CAS NUMBER HAS NOT BEEN ASSIGNED
                 RULE
                 CODE
**********  Selenium compounds—
**********  silver compounds—
**********  Thallium compounds—
            Thorium compounds—
**********  uranium compounds—
**********  Zinc compounds—
                sr313


                sr313


                sr313


                srllO


                srllO


                sr313
                             81
(06/30/90)
-------
NAME PROPOSED
•ME Of 40 CM MILE
CODE RULE Cl 1*1 ION DAIE
•1 PBO-HIS
e2 PU-IRIS
•S Asbestos 761
•4 Cl 704.45
•S CM 704.41
•6 NEK-8CN 704.102
PROPOSED
RULE I* fR
CIIAIION CIIAIION
4S
45
47
49
49
SO
fR
1*
fR
fR
fR
fR
7072S
7072S
11198
11181
11649
47*14
fR
puailSM
DAIE
10/24/80
10/24/80
07/10/82
01/26/84
08/24/84
1I/I9/8S
EfffCIIVE
DAIE
11/24/80
11/24/80
08/10/82
OS/2S/84
10/08/84
01/02/86
REPORIIHG
OEAOLIHE SUHSEI
DAIE DAIE HOIES
12/24/80
12/24/80
11/28/82
06/24/84
11/06/84
01/01/86
OS/OI/BS PolybroMMtcd biphcnyls portion.
OS/OI/6S Iris (2,1-dibroaoprapyl) phosphate portion.
08/01/87 Asbestos •anufecturers reporting.
Chlorinated terphenyla.
Chlorinated naphthalenes.
1. 2,1.4. 7.7-MMtthloronorbornodlene; or report no lotcr thi
o7    NSOCA
                           704.ITS
08    P-IMA, P-lil 8 P-18 704.11
      8
o9    HfPO
•10   11-M
                           704.104
                           704.2S
•11   Anthroquinono        704.10
•12   ED1NPA and Its salts 704.9$
SI fR 11220  04/18/86  06/02/86  07/02/86
SI 18 17116  OS/12/86  06/2S/86  08/21/86
S2 fR 41296  10/27/87  12/10/87 02/08/88
S2 fR 19860  OS/28/87  07/11/87 08/10/87
S2 fR 21018  06/04/87  07/20/87
SI fR 4111$  10/21/88  12/05/88 01/01/89
                                                            SI fR 4674S  11/18/88
10 days lro» •Muganent decision to produce.

4.4'-Nethylenebls(2-chloroonlllne); or report no loter then
10 days lro» •anagoo*nt decision to produce.
p-tert-Butylbeniolc ocld (P-IUA). p-tert-Butyl toluene
tP-IBI) 4 p-t«ri-8utylbmHldohydt (P-IU); or report no
Uter then 10 dsyt lro> aonogoMnt decision to produce.
HeiofluoropropylMO wilds or Oxlrone. trlfluoroitrlfluoro-
•ethyl I- ; or report no 1st or  then 10 dsys from MnsgeMnt
dtclslon to •enufocturo. loport. or process.

tt-Aoilnoinlecenolc ocld; or  report no lotor then 10 deys
fias sMinsgeasnt decision to  aonufocturo. loport or process.

9,10-AnthrotBjInano; report Mlthln  60 dsys of cospletlon of
every corporete fiscal year  during Utlch they •onufocture ar
ln>ort 9,10-AnthrKBilnone after 07/20/87.

PT-otphonlc acid. ||.2-othanadlylblaInltrllobU(o»thyleno)ll
tctrskls- (EOINPA); or report  NltMn U dsya of •aklng
certain SMnagesMit decisions.
Correction.
                                                                                                                       (06/10/90)
-------
MANE
RULE Of
rent nut
el Chlortndic

40 CFR
CIIAIKM
•ctd/Chlo
PROPOSED
RULE
OAIE

PROPOSED
RULE ft


ft
CITAIION
S2 ft 4U2I
ft
MJBIISN
DAIE


EffECIIVE
OAIE

IEPORIIN6
DE AOL IKE
DAIE
02/04/88

SUNSEI
DAIE


IrOIES
Biiycio(2.2.lihtpt-S-«


tt-2.)-dtc«rboiyllc


•eld. 1.4.5.6.7.7
      rtndic wAydrldt                                                                                    ht^Mhlcre- (Cfclormdlc ncldl I i.MMilianolcobcntofurMi-
                                                                                                         t.S-diont. 4.5>./.«.«-h»««ehloro-J«,4,?.7«-Utr«hydro-
                                                                                                         (Chlorcndic •rHydr !<<•>; r«qut«l for rtcords «n^ report*
                                                                                                                   •Ignltlcant advtrM rtactloro.
c2    lrl(A»ky»/Atto»y> Ph                                SI fl UOA   OI/I9/U           01/M/8A           tapcst lor record* And rtporU regarding tignlflcwtt
                                                                                                                 r«Mtlom.
                                                                                                                  (06/30/90)
-------
RULE
CODE
41
d2
dl
dt
cS
ctt
d7
aa
<«
dlO
dtl
d!2
dll
dU
dIS
d!6
NAME
or
RULE
aid)
0(d)
8(d)
8(d)
6(d)
8
8(d)
d(d)
BI.I)
B(d)
Bid)
8(d)
8(d)
Bid)
a
a

MEMO
ANEW
MEMO
AMEND
ANEW
ANEW
ANEW
AlttNO
ANEW
ANEW
ANEW
ANEW
ANEW
ANEW
ANEW
PROPOSED PROPOSED
40 MR RULE RULE fR IB
CIIAIIOM DATE CIIAIIOH CIIAIIOM
716.
716.
716.
716.
716.
716.
716.
716.
716.
716.
120
120
120
120
120
120
120
120
120
120
716.120
716.
716.
716.
716.
716.
120
120
120
120
120
47
47
40
40
49
49
40
49
SO
49
SO
SO
49
SO
SO
SI
fR 18791
fR S4624
IR 11170
ra 24166
fR 1696
ia iotas
fa SS6B6
fB 22286
fa 11697
fa 46741
fa 18061
f8 20909
f8 1696
fB 47518
f8 S292S
fB 2690
fa
PUBLISH
DAIE
09/02/82
12/01/82
01/10/81
06/01/81
01/11/84
07/27/84
12/14/81
OS/29/84
01/2S/8S
11/28/84
OS/01/8S
OS/2I/8S
01/11/84
1I/19/8S
12/27/86
01/22/86
EffECIIVE
OME
10/04/82
01/01/81
04/29/81
07/01/81
02/11/84
09/10/84
01/11/84
06/28/84
OS/08/6S
12/28/84
06/01/6S
06/20/OS
02/IS/84
I2/I9/8S
02/10/86
01/07/86
REPORIIH6
DEADLINE
DATE
12/01/82
01/04/81
06/28/61
08/10/81
M/14/84
11/09/84
01/14/84
08/27/84
07/07/8S
02/26/8S
08/02/8S
08/I9/8S
04/14/84
02/18/86
04/11/86
OS/08786
SUHSEI
OAIE
10/04/92
01/01/91
04/29/91
07/01/91
02/11/94
09/19/94
01/11/94
06/20/94
OS/0879S
12/28/94
06/OI/9S
06/20/8S
02/11/94
12/19/9S
02/10/96
01/07/96
NOIES
Ut-Sth and 7th IIC ft Aiteitoi.
7th ft Itth IK
6th • 10th IIC
12th IIC
10th (1 •Uturc) ft 11th (4 rtc.) IIC
mthylpyrldlna ft lUUIc anhydrldi.
llth IIC
14th IK
Uth IK (1 rtc.)
ISth IIC
Ur«a-forMldchyda raalna-M* also SO fB 4629S
16th IIC
C (9) tract Ion ftlitura
Uth IIC
Vinyl K«UU
11 ChcaicaU for OSUEB Land Olapoaal Btitrlctlon •ttntordt;
                                                                                                               non-ISCA Invtntory aubatancaa.

d17   B(d) ANEW           716.120                          SI fR 171M  OS/12/86  06/2S/66  08/21/86  06/2S/96 p-ttrt-Butylbcniolc acid (P-TBBA). p-Urt-Butyltolutm
                                                                                                               (P-IBI), and p-tart-Butylbtnialdthydt (P-1BB).
                                                                                                                       (06/10/90)
-------
MAE
CODE.
die
419
d20
dZI
422


421
424
NAME
or
MAC
8(4) MEMO
8(4) MEMO
8(4) AMEND
8(4) ANEW
8(4) AMEND


8(4) AMEND
8(4) «MEHO
M.OPOSEO
40 «• RULE
CHAT ION 0»IE
716.
716.
716.
716.
716.

716.
716.
716.
120
120
120
120
120

IS
120
120
raorosEo
MAE M fN
CIIAIION C 11*1 ION
SI
SI
S2
S2
S2
S2
SI
SS
SI
fft
M
IB
16
ra
16
18
IB
fB
16121
4IS28
16022
19027
44826
47990
46746
18211
46279
ft
NJBIIU
DAIE
OS/19/86
11/14/86
OS/01/67
OS/20/67
11/20/67
12/17/67
11/18/81
, OS/20/88
It/16/66
CHECH VE
DAIE
06/18/86
I2/1S/86
06/01/87
06/19/67
12/21/67


06/20/88
12/16/88
UPOailNfi
OEADUNE SUNSEI
DAIE DAIE
06/17/86
02/11/67
08/11/67
08/18/67
02/19/88


08/19/88
02/14/M
06/18/96
12/1S/96
06/01/97
06/19/97
12/21/97


06/20/98
12/16/98
NOIES
18th IK.
19th IK
Ola/OSU/OU/CMC • 102 MtatencM.
20th IIC
2t«t lie
Correct Ion.
Correction.
22n4 IK
2Sto IIC
42S   6(4) MttJNO           716.120                         S4 M 8484   02/28/89  04/11/09  06/11/89  04/11/99 Millet* liwrti; Inclutet 29 cheat col ei*etonceo.
                                                         S4 16 11478  01/20/89                             Corrtctlon.
426   6(4) MEND           716.120                         S4 ft 11248  07/27/69  08/28/69                   24 ih IIC; r«o«ts CM Ho. 2SSSO-98-S froa 17lh IIC (pll 6
                                                                                                         414); ra MM chMlcaU
427   8(4) AMEND           716.120                         S4 ft Still  12/12/89 01/11/90           81/11/00 25 th IK; Incluto* 12 chwlMl

428   8(4) AMEND           716.120                         SS IB 6012   02/21/90                            Sctatlluui lor Chlorofluoroctrbora (CICi).   Includttt
                                                                                                         CAS No. 7S-66-7. US Mo. 106-61-2. CM No. SS4-2S-6, CAS N
                                                                                                         SS4-11-6. US No. 611-97-2.  US No. 1649-08-7. art US No.
                                                                                                         1717-00-6.
                                     04/09/90 SS IN 11164                                                 Correct Ion; proposed rulo.   Corrects ISU cheilcol •Utwlen
                                                                                                         Inventory MM. trlvlol MM. end CM nuter  lor NCfC-124.
                                                                                                         In tho prtMd>to 6 codified tut. the third entry -- US No
                                                                                                         1S4-2S-6 -- ihaul4 bo 4tlotod 6 CM No. 2871-69-0. COMM
                                                                                                         MM. ISU chMlcol wtetenco Inventory MM  should te odd
                                                                                                                 (06/10/90)
-------
        NAME                                     PROPOSED     PROPOSED    HUM. MM.E   flHAL IME
MILE   or MAE                           *o era    IULC        imc»        fa          PUSLISM   EMECIIVE
CODE   OB PNM D                        CIIAIION   DAIE        CII/kllQH     CIIAHOU      Ollf       DAIE
•1    I2(b) taentacnt                   707        07/12/69   S4 H 2M24                                   Eiftori notification; riperllr« i rtcordkeeping.
                                                                                                                   (06/10/90)
-------
       NAME
MAE    Of
CODE   BIM.E
           MOPOSfO   PROPOSED
 40 CM       IU.I     MAC II        f|
CIUTIOM      DAIE     CIUIION    CIUIICM
               fl              UPOBIING
            PUUIU   CfftCIItt OEAMINf   BMSEI
              DAIE      DAIE     BAH     DAIi
                                                                                                           HOIEI
ft
Nolle*
12   forMlcfehyde        Molict

                        •otic*

fl   1.1-lutadlona       nolle*


14   Mthylane dtlorld*  Nolle*
4* fl I90»  M/2r/U

4B fl 428M  09/20/U
                              49 fl 21698  OS/2I/M
                              49 fl 2»ro  OS/2I/M
                              46 fl S2Mr  II/U/A1

                              49 fl MS    OI/OS/M
                              49 fl 20S24

                              SO fl 2012*  OS/U/tt
ItrjcnMln*. 4,4'-Mlliyl*mbU* or 4.4'-Mthyl«MdlMllln*;
InllUtlon of r*vl*M.
InliUtlon of ••guUtory Action; Advanced Nolle*
of Propotod luloMklng CANPI)

0*t*rairatlcn of •Ignlflcont rltk.
Ocuralratlon of •lanlf leant rUk; (AWI).
•tcomldiroilon; *ellelt*tlon of coHHnl.

InltUtlon of AccoUrottd Imlm.
Initiation of loaulotory Action; (ANPI).

Initiation of Acc*l*r*tod lavl*M.
                                                                                                            (06/U/90)
-------
        MANE                          PROPOSED   PROPOSED                    fl                 REPORIING
RULE     Of              40 Cfl         RULE     RULE II          fR       PUM.UH    EffECIIVE  DEADLINE
CODE    RUtE	CIUIIOII	OAIE	CIUIIOM	CIIAIIM	OAIE	OAIE	OAIE	MOlEi
•I    CAIR             TO4.22S                               SI fl SI69A  12/22/88   02/06/69             Sit f«ter.l RcgltUr nolle* for various rtporilng dales;
                                                                                                         Includes 19 chMlcal sutwlancti.
                                                             $4 fR 6918    02/IS/89                       E«l«ul
-------
MAE
COOf
pt
f*
pi
pt
ps
P6
pf
PB
P»
plO
pit
pli
pi]
pU
p»
p16
Plf
pia
MANE
or
MILE
Mil
Mil
PAII
PAH
PAII
PAII
PAII
PAII
PAIR
PAII
PAII
PAU
PAII
PAII
PAII
PAII
PAII
PAII

ANEM
AHEM
ANEW
ANEW
ANEW
ANEW
ANEW
AMEND
ANEW
ANEW
ANEW
ANEW
ANEW
ANEW
ANEW
ANEW
ANEW
PROPOSED
40 CM RULE
CIIAIION OAIE
7l2.M(d)
712.10U)
7i2.iO(D
712.10(11)
712.UIJ)
712.SOU)
712.U(0)
ri2.u(i)
7t2.10(a)
712.10(11
7l2.10(n)
712.10(0)
712.U(p)
712.10(4)
712.10(1)
7l2.10(u)
712.U(v)
7I2.10(M)
PROPOSED
•WE fl ri
CIIAIION CIIAIION
47
47
40
40
46
49
49
49
49
SO
SO
SO
SO
SI
St
S2
S2
SI
fl
fl
fl
fl
fl
fl
fl
»
fl
fl
fl
fl
fl
fl
fl
fl
fl
fl
26992
2*992
22694
26441
SSoBS
22264
2S6S6
2S6S9
46719
II69S
10661
20909
47)10
10121
41120
19027
44026
10107
fl
PMIIM
OAli
06/22/02
06/22/02
OS/19/01
06/22/U
12/14/01
OS/29/04
06/2S/04
06/21/64
11/20/04
01/2S/OS
OS/01/OS
OS/2I/OS
' 11/19/OS
OS/19/06
11/14/06
OS/20/17
11/20/07
01/11/10
EffECIIVE
DAIf
07/22/02
07/22/02
06/20/01
07/22/01
01/11/04
06/20/04
00/00/04
06/00/04
12/20/04
OS/M/OS
06/01/OS
06/20/OS
12/19/OS
06/10/06
12/IS/06
06/19/07
12/21/07
OS/16/00
•EPMIIH6
DEADLINE
OAIE
11/19/02
11/19/02
00/17/01
09/20/01
01/11/04
00/27/04
10/00/04
10/00/04
02/26/OS
07/00/OS
00/OI/OS
00/19/OS
02/10/06
00/10/06
02/12/07
00/10/07
02/10/00
07/11/00

Ul •
Ul •
6th •
Ulh
till
Ulh
111*
NOIEI
sth a toth nc
Ird IK IS CM.)
9lh J.IC
IIC
IIC
IIC
lie
NMltyl Ml*
ISth
Ulh
UfW
16M
17lh
10th
I9lh
20th
2UI
tic
IIC (1 rw.)
fenwlditiyite rMlm
IIC
IIC
IIC
IIC
IIC
IIC
OutrtKh PAII • OAQPS.
C06/10/90)
-------
        MANE                         PROPOSED    PROPOSED                    fl                 REPORTING
IULE     Of              40 Cfl         MAE      RULE fl          fl        PUHISN    fffECIIVC  DEADLINE
CODE    RUIE	CIIAIION	OAIE      CIIAIION	CIIAIIOH      OAIE	DAIE	DAIE	HOIEI
p19   Mil MEND        712.10(n>                              SI II 16211   OS/20/aa   04/20/68.  08/16/66  22nd 11C

p20   Mil AMEND        7I2.10(M>                              II fl 4*219   11/16/68   12/16/68   02/14/69  21nl IK.
                                                              54 fl 4109    01/27/69                       Correct ton.

p2t   PAIR AMEND        712.IO(M)                              5* fl M84    02/28/69   04/11/69   06/11/69  fcstlcldt  liwru; Includt* 29 chMlcal tUniwicti.
                                                              $4 fl 11478   OS/20/19                       Correction.

p22   PAII AMEND        712.U(M)                              S4 fl 11248   07/27/19   06/26/69             24th 11C;  removes CAS No. 2SSSO-98-S fr« 17th I1C (ptS I
                                                                                                          dU); no MM choalcoU ocfcted.

p2I   PAIR AMEND        7l2.10(n)                              S4 fl SI11I   12/12/69   01/11/90   05/12/90  2ith IK;  Inclutet II chctilcol
                                                                                                                     (06/10/90)
-------
MJli
COOL
NAME
 Of
suit
flNAL IULC
   fl
CUM ION
MHAL lULf
   fl
  OMi
CffCCIIVf
  0*11
                                                                                 Mill
rl    a (d)
r2    Olemiol  revleM B(d) report pe
      rlod tersi.
                                    SO fl 19677
                                    •SI l« 12U
              09/IO/6S
              01/09/86
            01/11/66
            01/11/66
                                    SI fl 16642   09/10/66    12/29/66
                                            SI fl  4S6S6   11/10/66
                                            SI fl  49966   12/12/86
                                            S4 fl  617     01/09/89
                        of seven Mtetonces  Iresi the Model 8(d) rule.
                •evlslon to the decision to  roaove
                                        • tram the ondel 6(d) rule.
                                          Iht reporting periods for IS iti»t*nce* lUted In 40 Cfl
                                          716.120(0) Mill bo liralneied 12/29/68.  thlo U rapretcntod
                                          by the rule code rl.
                                          Ihe reporting periods for certsln Individual *as)ers of the
                                          cotegorr •fnenylenedle«lnsa nit I  be  loralnotod 12/29/88.
                                          this U represented by the rule code r2.  Mouewer, for ell
                                          other OMtMrs In the "nienylenedleeilne* cotaaory. the
                                          orlglnel tunsot dsto Mill rcaoln  In  effect.
                                          Ihe repartlng period for five cotegorloe Holed In 40 Crl
                                          ri6.120(c|--*Uyl eposldee. AUyttln caopounds. Chlorlooted
                                          Herfclholenes. Ithyttolueneo end Helogenoted Alkyl IpMldie--
                                          Mlll bo teralnoted 12/29/66.  IhU lo  represented by the
                                          rule code r2.  Certain eiAetencee Mlthln these cotegorlee
                                          hove been treraferred to tho Individ*! listing In 40 Cfl
                                          716.12010) end their origins! stMOt dsto* roaeln In offoct.
                                          Correction.
                                          Correction.
                                          Correction.
                                                                       10
                                                                                                             (06/10/90)
-------
NAME
BUIE Of BULE
CODE OR PMN •
al HEI-BCN
•2 HHPA
cl Urathana
•4 PCE
aS PBB§

(6 IBIS
«7 NBK
SO 11-AA
40 era
CIIAIION
721
721
721
721
721

721
721
721
.1150
.1200
.2550
.1475
.600

.2200
.1100
.150
PROPOSED
RULE
OAIE
02/22/65
10/10/64
10/10/64
01/24/66
07/07/66

07/07/66
07/07/66
07/22/66
PROPOSED
RULE ft
CIIAIION
SO
49
49
SI
SI

SI
SI
SI
fR
fR
fR
fR
fB

fB
fB
fB
7151
19701
19701
10024
24SSS

24S5S
245S1
26271
fINAL BUIE
fa
CIIAIION
SO
SI
SI
SI
S2

52
52
52
fB 47514
fB 9450
fB 9450
fB 12077
fB 2699

fB 2699
fB 11622
fB 19860
fINAl RULE
PU6LISN
OAIE
11/19/65
01/19/66
01/19/66
09/09/66
01/26/67

01/26/67
04/11/67
05/26/67
SffECIIVE
DAIE
01/02/66
05/02/86
05/02/86
10/21/66
01/11/67

01/11/87
05/27/67
06/11/67
NOIES
Nc>*cMcranorborn*dl«na or
Intcraeelat* In tha production of Uodrln or tndrln.
Nc»io*lhylp)ioiphoro»lda; any uaa.
Any uia.
Ptr.iachloreathana; any u>a.
PolybroBlnatad blphanyla • Include* 6 chcailcal aubaiancca;
any uta.
lrla(2.}-dlbro*opropyl) ohocphata; any uaa.
Naihyl n-butyl latent; any uaa.
It-AjMnoundtcanolc acid; any uaa othar than aa...(l) an
•9    HIM
                                       721.1175    01/02/67   52 fB 107     52 fB 41296   10/27/87   12/10/67
EBN
TC60
UNUSED BULE CODE
UNUSED BULE CODE
721.950
721. 975
NONE
NONE
52 fB 41296
52 fB 41296
NONE NONE
NONE NONE
10/27/67 12/10/67
10/27/67 12/10/67


InuracdUic In Ikt awulKlurlng of polyMfi  In on •ncloi*
prwtM Mhm It U OipMtod that tho 11-AA Mill bo fully
polyintrlitd durlnfl Iti* •MMfacturlng procMa.  or (ll> a
cotpcncnt  In pnotoprocaailug aolutlona.

HcEafluoropropylano oildt or OHlrant. trlfluoro(trlfluoro-
Mthyl)-;  any ma othar than aa an Inuraadlata In tha
aanufaciura of f luorlnatad attetancaa In an ancloaod
prccitt.
Eplbraacltydrln or (Ulran*. (broMoathyl)-; any  ma.
frUhlorobutylana'uida or Oilrana. (2.2.2-irlchtoroethyl)-
any wa.

HOIE: Ihla la an musad BULE ODE.

MOIE: Ihla la an unuaad BULE CODE.
                                                                      11
                                                                                                                  (06/10/90)
-------
        NAME
IU.E   Of RULE
 40 Cfl
          PIOPOSEO     raorouo     riiui tun   HNAI «mc
           (UlE        MN.E ft         fl          PUBUM   EffECIIVE
           PIE        CliMIOM      CIUIIOM       DUE _ B*U _
•12   62-400



      62-409

•IS   60-289


      60-290

•14   6I-10S


•IS   83-21
      81-24
      81-49
      8J-75
      61-272

•16   62-126

•17   U-21?

•16   61-330


•19   62-664
721.1750    02/17/81   48 fl 7142    49 fl MOM   09/05/64   10/19/84
                                                                                                    COCOM|M o«lda ptioiphtu
                                                                               «,H-bU(hydrejiy«thyl) tallOMMiin* o«l-81-272)
          awnufactura or procaaalng ultbout f>»l Mharo daraai contact
          Inhalation My occur A notify;  tubatltutad 2-phanmypyrldl
          (P-81-21 A P-61-75) -• awnufactura or procaaalny without
          WE Mharo danaal contact awy occur A notification; 5(a).
            02/06/84   49 M 4190

            02/06/84   49 ft 4190

            02/06/64   49 fl 4190
                                                                      NonS(a).

                                                                      S(o) Conaant Ordar.

                                                                      Hun-S(o).  It appaara that tha corract MM Ho. la •-6MH
                                                                      not f>-82-110. aa pravloualy aaon In COil.
721.2100    01/01/84  49 fl 91      49 fl 42926   10/25/84   01/07/85  Oorivatlva of tatrachloroathytana •• awnufactura or
                                                                      procaaalna without PPE Uiar* danaal contact/Inhalation MI
                                                                      occur; Mnutactura or procaaalng Mlthout raqMlrlna contali
                                                                      /Jonulatlon containing aubatanco to ba packaged to pravai
                                                                      Itakag* and !abaIad to hand!a only with •»£; 5(a).
                                                                        12
                                                                             C06/10/90)
-------
        NAME                                      PROPOSED    PROPOSED     flNM. RUIE   MHAL RULE
RUE   Of RUIE                          40 OR     RUIE       RULE fR         fR         PUBLISH   EffECIIVE
CODI   OR PUB i	CIMMOH    OME	C11*1 ION      CIUIIM       OMi       DUE	jlOIJi	
•20   81-2SS                           721.600     01/01/64   491182      491841061   10/26/64   01/16/6)  DUerbo«yllc acid ewMoeter •• eny •enufecturo In US lor
                                                                                                            conmcrclel purposes;  folluro to reojilre PPE ute'uhere den»sl
                                                                                                            conuct MX occur;  distribution In cooserco Mlthjaut •tlUIng
                                                                                                            utrnlng l»hel to conlalntr; )(•).

•21   U-iro                                       01/11/64   49 fR 17SI                                     5   at vuo                                       09/26/64   49 IR 16101                                    S(e> ConiMt Order.
      a I vud
      B) V09
      61-910

•26   61-769                                       09/26/64   49 16 16110                                    »(a> Concent Order.

•27   61-1021                                      09/20/64   49 16 16660                                    »<«> Coraent Order.

•26   62-416                           721.S75     01/02/6S   SO 16 127     SI 16 16664   OS/06/66   07/21/66  Oeniolc ocld. ].I'-Mlhyl«nebU|6-Mlno-4l-2-propcnyl|
                                                                                                            •iter •• (I) ony u>o  other then the uee described In PIW Mo.
                                                                                                            P-62-416 6 (II) any evnner or Mthod of Mnufecturlng or
                                                                                                            processing for use  described In PNH No. P-62-416 different
                                                                                                            than •emer/Mthod  described In PM Ho. P-62'418; non-S(o).

s29   61-617                                       10/25/64   49 16 42960                                    Hon-S(o>.

•10   61-816                                       10/25/64   49 fR 42960                                    Mon-JCel.
                                                                       11                                           (06/10/90)
-------
        NAME
MAE .  Of MKE
           PROPOSED     PIOPOKO
 40 CM     MAE        lUlf fl
Cl1*1ION    DAIE        CIIAI10H
                                    flHAl HUE   flHAl MJlf
                                       II          PMLIM   EMECIIVf
                                     CIIAIIOH       OAtf      OtIC
                                                                                                                    MOIfS
•II   61-822
•12   54-27

•II   64-176

•U   84-180
      84-181
      84-182
      84-IBS
      84-184

•»   64-IOS
      64-106
      84-107

•16   64-417

•17   61-108S

•18   64-141
      64-142
      84-141
      84-144

•19   64-274

•40   64-1042

.u   »4 r
            01/2I/6S   SO fl 11184



            01/21/6}   SO fl 11191

            06/26/8S   SO fI S4SOO

            04/04/86   SI fl 11S91
            08/26/8S  SO fI S4SOS

            01/24/86  SI fl 10027

            01/11/86  SI fl ISM-
721.400     12/07/64   49 fl 47674   SO fl 14461   06/26/6}   11/06/8}  0!ti*o:lluted dltalm onleoto •• (I) UM other then et en
                                                                     tuteroKdUto i  (II) •onufocturo. loport. or protecting for
                                                                     me n on InleroodUto Mlthouti providing protective glove
                                                                     end requiring ptcktgn to bo totaled for ute/hendled only
                                                                     Mith InpervloM glove*] $(•).

            12/24/64

            01/27/6}

            01/27/6}   SO fl 12046
                                                                     S(tl Consent Onter.
                                                                     S(o) Content Order.
                                                                     »(e) Content Order.



                                                                     £(e) Content Order.

                                                                     S(e) Content Order.

                                                                     Me) Content Ordtr.
                                                                      !i(o) Content Order.

                                                                      )(•) Content Order.
                                                                       14
                                                                                                                    106710/90)
-------
        NAME
 Ulf   Of BUK
 1PE   08 PKH j
                                                  PROPOSED     PROPOSED     flMAL BUlf    flHAl lUlf
                                        40 era     tuif        auif fa         fa         PUBLISH   ffiEcrm
                                       CHAIIOH    OAIE	CIUIIOH      CHAIIOU      OAIE       OAK
                                                                                                                     HOIfS
42   84-660
     84-704

.41   84-1054
     04-1056

44   86-81

4S   06-542

46   UE

47   1-Oacanoailna. N-decyl-N-Mthyl
 40   Olf*icnyl-2.4.6-lrlMlhyltenioy
      I  phosptttn
      4-COI.  4-COI hydrochlorldi 4 6
      •COI
.SO   f>EO

.SI   06-1122
 52   OS-929;  1.1-BenitnedlMitnt. 4-
      (1.1-Olnei
                                       721.640
                                       721.462
01/10/06   SI fB 9221
06/11/06   SI fB 21190
                                                                                                             S« U.S..  (apart In dual or powder  fora aaaoclated
                                                          Mlih eny uaa «lthln tha U.I., or uta other than In tolutlon
                                                          Mlth Slyrona.

09/16/88   SI fa 16079  S4 fB I244S   01/27/09  OS/10/09  Beninnenlno. 4-chloro-2-Mlhyl- (4-COI).
                                                          Bcniwwnlne. 4-chloro-2-Mlhyl>. hydrochlorlde (4-COI
                                                           hydrocMorldt).  and
                                                          BenittnMtlne. 2*chloro-6-eMlhyl- (6-COI); any uea.
09/10/08   SI fB 18411                                    Corrucilon; propoted rulo.
                        S4 fO 17707   04/2S/09  04/2S/89  Correction; flnel'rulo.
                                       721. ISIS     11/22/00   SI fa 47220   S4 fB 18204   04/20/09   06/12/09 f>«ntabronoothyltMniena; any uaa.

                                                   12/2B/U   SS fa S244I   S4 fB 1BUI   09/10/09   12/01/09 Nltturc of I.I-OonienedlMlnt. 2  (or 4)-Mtftyl-4.6 (or 2.6)
                                                                                                            bU(Mihyllhlo); S(o) Conaonl Order.

                                       72I.SSS      OS/11/09   S4 fB 21212   SS fB 20792   OS/21/90   00/01/90 I.l-Benienedleoilne. 4-(l.l-dle»lhyl)-ar-Mlhyl.  ISCA S(a)
                                                                                                            consent order.  Slgnlf leant MM ueee and rocordkeeplng
                                                                                                            rcquUtoenia for ewnufacturara. lifioriere, or proceieorei
                                                                                                            use oilier then for afpllcotlona Uiara It Mill be completely
                                                                                                            reacted; dltpotal of tho at^eteneo other then by
                                                                                                                     (06/10/90)
-------
        MNt
MM   Of lUlf
CCOf   M flUI I
                                                riwosio     rioKnto     IIMU autf   fun
                                       40 Ml    lUif        IIAf  II         ||          ftJllIU   IllfCIIVf
                                      CIUIIOM   0>II	CIUIIOH      CIUIIM       0«|f       Mil
                                                                etoiis
•SI   OS-4II

aS4   2,4-Pent anwliona
M/12/16  SI II UiM

o9/i;/w  si it mti
10/16/10  Si II iiil*
•SS   Stfcsillulia lor Chlorolluoraca    HI.760    02/21/M   SS II 6012
      rtona
•So   iipcdllad IHUI lulo-IKA (Mil
      Ml SUM2)
•sr   r-w-ui
                                      KI.2M
      P-09-6SO
      f>-09-6SI
                                      fit.1012
                                        I.166
                        Si II SIIM   Or/U/M
                                                                                                         InclMrallan or landllll| my namr or Mtkad of
                                                                                                                  a, laporl, or procaaalng ultkaut aalablliklni a
                                                                                                             rt» itfiarabyi III paraona aipoaad dtiMlly and by
                                                                                                                   Mar paraonal prolacllva at^loMni, 12)  ... aro
                                                                                                         InlarMd of kaiardi and ra^ilrad paraonal protect I va
                                                                                                         a«fc>Kntnt( III conlolnar* ora labalid. and (i) a|icccdlng a
                                                                                                         •txclflcd proiAtcllan Halt prior to conplatlon ol cartaln
                                                                                                         tciu;  and a»lnlaln tacorda for i yaara aftar tka data of
                                                                                                         lh<-lr craatlon by paraoM Uto •anufactura, Iqport.  or
                                                                                                         prwfti. Including Mall bualMtMt.

                                                                                                         l-PrcMnol, l-o«rcaplo-| S(a) Coiucni Order.

                                                                                                         Um In  conatavr product!.
                                                                                                         CarraclJan.

                                                                                                         any uaa oikar tkan M on Intaraadlalo fari
                                                                                                          HhaM. 2-ckloro-M.Mrllluoro- |UI Ma. 7S-M-7).
                                                                                                         An/ uaa fart
                                                                                                          likana. |.2-dlckloro-t.l-dllluoro- |CAS Ho.  IA4V-08-ft.

                                                                                                  / /    f ipcdllad procaduroa ft otandard algnlf leant MM uaa
                                                                                                         dolinallana aalabtltkad In awntamla In 40 Cfl fart 721
                                                                                                         far proBulgatlng Olracl final IMJIa.
                        SS II INI*   Oi/2i/M   M/21/M  I Irti rula latuad ualnt a«f«dllad fM-ocadjraa and alantord
                                                        alinlllcani MM MO daalonallona (f«a Mil lula Coda aSA f
                                                        •or* InlofMilon).  Alkanopalyol Bhaaonalo attar Iganarlc
                                                        ni«lllutad olkanalaolnai
                                                        •rvl carbounocycllc dlcarboiyllc acid Iganarlc IMM).
                                                        Sigiillicani MM utaa arai Indutirlal. comarclal. ft canti*
                                                                                                                 IM/IO/MI
-------
        KANE
RULE   Of RULE
CODE   OR Mill <
           raOTOSEO     PROPOSED     HUM. IUIE   MNAL IUIE
 40 CfR     RULE        MllE  fR         fR          PUBLISH
CIKIIOM    DME _ CIUIIOM      CIMHOH       OME
                                                            EffECIIVE
                                                                              •DIES
      P-09-701
      p-69-755
      P-B9-7S6
721.29$
721.295
721.29S
                       HONE
                       HONE
SS fR 1717*   04/24/90   06/25/90
IS fl 17176   04/24/90   06/25/90
                                    SS fR 17176   04/24/90  06/2S/90
•SB   Certain AroMtlc Ether OlMlna    721.70S     OS/10/90   SS fl 21667
§59   Significant Km Usea of Cartel    721
      P-66-1469

      P-84-591


      P-S4-9S4



      P-ft* 824
721.296

721.44S


721.450



721.52)
                       NONE

                       NONE


                       HOME



                       HONE
                                                                            SS n 26092   06/26/90   06/27/90
                                                                            SS H 26092   06/26/90  06727/90
SS » 26092   06/26/90  OB/27/90
SS » 26092   06/26/90  00/27/90
SS ft 26092   06/26/90  OB/27/90
         product! of ••comtery olkyl Minis Mlth  •
•itetlluttd btnitmtulfonlc ocld and tulfurlclAcId (generic
rum).  Significant MM MM orot IrduttrUI. 'comercUI. I
coramer actlvltUs.
•cactlen product* of •tcondtry alkyl talnei Mlth •
substituted BtiutnMulfonc ocld and •ulfurlc  acid (generic
MM).  Significant nan uaaa orai Industrial,  comrclal. I
consuatr actlvltlaa.
•«actlon products of secondary alkyl nines tilth a
•ttalllutad bcniamsulfonlc acid and sulfur I c  acid (generd
mm).  Significant nan uaaa arat Industrial,  coonerclsl, i
consuMr acilvltlas.
Chealcsis covered Include: r-BS-llS, P-8S-IS6. P-6S-5I7.  «
f-BA-1151.  Significant nan uaaa Include: »•«->» •- the
awnufactura. loport,  or processing of o specified annual
voluna. Mhlch la confidential, for any use; »-as-336 end
••65-117 •• any uac;  and r-86-IISI - awnufactura. Isport.
or processing of a specified annual volusa, Mhlch la
confidential, for any use.

Direct final lute for aavaral cheat eel substances. Mhlch
Kara the eubject of fra-Nanufactura Kotlces (Mils) and ISC
section 5(e) consent  ordera.
tikylphenosypolyalkojiysailna (generic neew).  Slgnlflcent  r»
u»ea arat hsisrd couutlcatlon progrea) 1 ralaaaa to Mater.
Sodlus salt of an alkylatsd. aulfonatad aroawtlc (generic
nana).  Significant nsu uaaa arai Industrlsl, coonarclal, <
consunr actlvltlaa
Subatltutcd aroMtlc  (generic neaw).  Significant ney uses
ara: protection In tho Morkplaco; kaiard coMuilcatlon
progress Industrial,  coMaarclol, t consusar activities; an
releesa to Matar.
Broalnaled arooMtlc cooiMund (generic na«e).  Slgnlflcent
r«u uses arai protection  In tho Morkplaca; haiord
conmnlcatlon progrea; Industrial, comerclal ft consuMr
activities; and ralaasa to Meter.
                                                                        17
                                                                                                                      (06/10/90)
-------
        NAME
MAC   Of MJlf
CODE   01 PNH ff
          •BOPOSEO     FBOPOSEO
 40 era    MHI        MAE fa
CIUIIOH   OAlf        CIIAIIOM
                   auu   MMI BUI
                ft         PUBLISH   EHECIIVt
              CIIAIIOM      BAff       Dili
                                                                                                                  UntfS
      •-BV911
      p-89-770
      P-B7-S02
     P-B9-S06
      P-86-562
     P-89-279
     P-6V961
     p-as-Tio
721.612
             SS II 26092  06/26/90   00/27/90
      p-aa-au
HI. 770
721.781
721.792
721.976
721.1060
                                      721. KOI
                                      72I.158S
                                      721.1630
                                       721.165*
HONE
                                                            HONE
             SS fa 26092  06/26/90   OB/27/90
SS fa 26092  06/26/90   08/27/90
             SS fa 26092   06/26/90   08/27/90
             SS fa 26092   06/26/90   08/27/90
                                                                          SS fB 26092   06/26/90  08/27/90
                                   SS fa 26092   06/26/M   08/27/90
                                    SS fB 26092   06/26/90   08/27/90
                                    SS fB 26092   06/26/90   08/27/90
                                    SS  fB 26092   06/26/90   08/27/90
M'-aU(2-(2-(l-atkyl)thlaiollM>vlnyl)-1.4-
pUmylonadloBlM Mlhyl aulfato doubt* salt  (oemrlc nan*).
Significant MM IMS oroi protection In tht  Morkpltct;
h«iard covuilmlan progr**;  InduitrUI. coM^rcUl t
conttMf KlIvlllM.
Coconut oil. rtKtlen product! Milk ittr«hydro»y branched
olkoni oitort of trltutatltuttd bMUontpropwwIc ocld
CgMitrlc ROM).  Blonlflcont non ustt oroi Industrial.
COMMIXtol. A corauBtr octlvltUi.
OUUcnyloildt (gonorlc MM).  Blanlflcont ntw UMI ar«i
protoctlon In tho mrkploco} hoiard coButlcotlon progra*;
Induairlal. coMirclal. B contumr octlvltlaa;  and disposal
AUylatad  dlarylaalna. aulfurliad lomarlc MM>.
ilgnllleant nan was ara» Induatrlal. ccawrclal.  B contuM
actlwltlaa.
rarfluoroolkyl apulda C0tnarlc IMM).  llgnlfleant nau uat
arot protoctlon In tho Morkplaca; kaiard coMuilcatlon
progroBj Induairlal. coaMrclal. B canauMr octlvltlaa;
disposal;  and ralaasa to Matar.
foraaldthyda. palyaar Mlth bltpkanol B and ouballtutad
phtnol (ganarlc naaw). Blanlfleant nan uaaa arat Industrial
ceaMrelol. B canauasr activities.
6-tfltro-2(lN)-bsnioiaiolona.  Significant ntM uaaa ara<
protactlon In tho norkploco; haisrd coaaunlcatlon program;
Industrial. coMorclal, B conauMr octlvltlaa)  and ralaaaa
to Mtor.
Si^atltutad pkoaphoto attar (gansrlc MM).  Blanlf leant m
usaa arot  protoctlon In tho Horkplaeo; haiard coaauilcatloi
prograoj  Induairlal. coMtrclal  B conausar act I wit Us;  and
ralaaso to Malar.
f>olya»r of olkonapolyol and
polyalkylpalylaocyanatocarbooxinocyclo. acatona oilM-blocki
Iganarle MM).  Blanlflcont MM uaaa arat Induatrlal.
ccaMfclal. and conauMr actlvltlaa.
PolyMr of alkanalc ocld. aubatltutod olkylacrylata aodlua
aalt (gcnsrlc MM).  Significant MM uaaa oroi Industrial.
corned at. B conauaar actlvltlaa.
                                                                      IB
                                                                            (06/10/90)
-------
        MANE
•U.E   or MILE
CODE   0» PMM •
           PROPOSED     PBOPOSEO
 «o c»     MAE        MILE fi
CIUIIOM    OME	CIMIIOH
                   HUE   fiiui tuu
                fl          Mil ISM   EffECIIVE
              Cl1*1ION       PJIf       DAIf
                                                                                                                    HOIES
      P-89-292

      •-89-S96


      P-86-SOO



      P-86-S02



      P-8S-9I2



      P-85-91)



      P-84-482



      P-89-SOI

      •-84-ioo7
Ml. 1890

721.2070


721.2112



721.2112



721.2192



721.2192



721.2480



721.2490

721.2585
HONE
HONE
DONE
HONE




HONE




HONE




HONE

HONE
SS fl 26092  06/26/90

SS fl 26092  06/26/90


SS fl 26092  06/26/90   08/27/90



SS fl 26092  06/26/90   08/27/90



SS fl 26092  06/26/90   08/27/90



SS fl 26092  06/26/90   08/27/90



SS fl 26092  06/26/90   08/27/90



SS fl 26092  06/26/90

SS fl 26092  06/26/90
t60   Significant Hm Uaea of Ccrul    721
      n Cheated
                                                             HONE
                                    SS fl 26102   06/26/90
08/27/90  Carbuy alky! ally! Mil (genarlc MM),  significant MM
          u«ta arai Induatrlal, caiMrclat, A coMuoar ^ctlvltUt.
08/27/90  Aikyltna glycol tarolithalau and utatltutcd lieniMta att«.
          (gcntrlc IMM).  Significant nan uaaa aras Inftjatrlal.
          cwmrclal 8 conauoar actlvlllaa.
          latraglycldalaalnaa tganarlc nan).  Significant new usa*
          arat pratactlon In the mrkplaca; hatard caHauilcatlon
          pregrM; Induatrlal. co«MrcUI. 8 contimr actlvltlai;
          diipotal; and ralaaia to n«t«r.
          latragtycldalaalnaa Iganarlc MM). Significant  ACM u»ea
          ara: protection In lha Mrkplaca; haiard conMitcatlon
          progrca; Induatrlal, coHDtrclal. A conimr actlwltlaa;
          dlipoaal; and ralaaaa to Mttir.
          OliiAatllutad alkyl trlailma  (ganarlc MM).  Significant
          MM utaa arai protection In tha Morkplaca; haiard
          coMuilcatlon prograa; Industrial, coaMrclal. A coruuwr
          Mtlvltlaa; and ralaaaa to Mtar.
          Olauballtutad alkyl trialIMI  Iganarlc MM). Significant
          nm uaaa arat protection In tha Morkplaca; hatard
          tooBuilcallon progra*; Induitrlal, coBatrclal. A canaimr
          actlvltlaa; and rolaaao to nater.
          urea, condmaata itlth polytoiyCMthyl-I.Z-athanadlyDI*
          «(^ia-(2-M
08/27/90  S-«lkyl-2-(2-anl!tno)vlnylthlaiollnlua aall (ganarlc i    I
          Significant nan uaaa arat pratactlon In tha workplace;
          haiard cooMilcatlon progra*;  Induatrlal, coaBarclal, A
          ronauMr actlvltlaa.

08/27/90  Cirect final lute for aavaral  chMlcal aUbatancea. Mhlch
          Mara tha aubject of Pra-Nanufacture Hotlcaa (PNHa) and ISC.
          cectlcn 5(e) conaant ordara.
                                                                       19
                                                                             C06/U/90)
-------
        NAME
lULf   Of MAC
coot   o» tm »
          •BOPOSEO     raorasEO     fiiui IU.E   MMI tuu
 «o CM    nui        tuif»         M         run KM  EMECIIVE
CUM ION   OME	CUM ION      CUM ION       OME      DME
                                                                                                                 NOIff
      •-06-104I
     P-06-1044
     •-B6-12S2
     P-06-S01
     P-06-SOJ
     ••86-620
     •-84-1079
     P-OS-S68
                                      721
721.291
721.291
721.617
                      MOHfi
HONE
             SS » 26102  06/26/90   08/27/90
SS fO 26102   06/26/90  00/27/90
             SS fO 26102   06/26/W   06/27/90
             SS » 26102  06/26/90   OB/27/90
721.782
                                      721.702
721.010
                                                            MOMC
                                                            NOME
             SS » 26102  06/26/90   00/27/90
                                   SS M 26102   06/26/90   00/27/90
             SS fO 26102  06/26/90   00/27/90
                                      721.OS1
                                      721.1070
                      HONE
                      HONE
             SS fO 26102  06/26/90   00/27/90
                                                                         SS 10 26102   06/26/90  00/27/90
Olract PlMl till* for aavaral dmlcal utalmcM, Uilcb
MIT* the •lAjwc of Prt-IUnifacturc Hot let* (mil*! and ISO
•tctlon $(•) canHM ordirt.
Nonoutatltutcd •UoiyMlnatrailMt Cgtmrlc n*iw).
Significant MM MM wci protwtlon In iht nortplM«;
haiard coouilcatlon preorMi} Industrial.  CMMrcUl. I
corauMr •ctlwltlts; dlapMtlj  «nd raUwt to y«i»r.
Nonotubttltutod olkuyMlnotrailnts Cgtmrlc MM).
Significant MM MM oroi protocllon In tha Morkplaca;
haiard coaiuilcollon prooraa; Induitrlol.  conwrclal. I
conauaar actlvltlaa; dlapoaal;  t ralaaaa to Mtar.
Oorlc acid, alkyl and •ubatltutad alkyl aatara Cgenarlc
MM).  Significant MM Maa arai oraiactlon In tha
MOfkplaca; haiard caaouilcotIon program; Induatrlal.
coMorclal, ft  conauair actlvltlaa; dlapoaal; t rolaaao to
Mtor.
AroMtlc dlaailMa (gtnarlc MM).  Significant MM uaaa ar
protoctlon In  tha Morkplaca; Miard coHutlcatlon progras;
InAjatrlal. coMarcUl, A conatavr actlvltlaa; dlapoaal; A
ralaaao to Malar.
AroMtlc dlaalnaa loanarlc MM).  Significant MM uaaa ar
protocilan In  tha Morkploca; haiard coaauilcatlon prograai;
liA«irlal. coaaMrclal. A conatavr actlvltlaa; dlapoaal; I
relaaaa to MB tar.
OSMr acid*. polyMr Mlth polyalkylaM glycol. bliphtnol A
diglycldyl athar. and alkylonapalyola polyglycldyl athara
(Bomrlc MMh  Significant MM MM ara« protoctlon-In t
Morkplaca; haiard caaauilcollon progrM; Induatrlal.
coMMrclal. A  comiavr actlvltlaa; A dlapoaal.
Alkylotad diphany! oxldo (oonarlc MM).  Significant MM
Mao oroi protoctlon In tho Morkplaca; haiard covunlcatlc
p*oara«; Induatrlal, coaaarcUl, A COMUMT actlvltlaaj A
Mtaaaa to Matar.
MilMlkyl aitetltutad cyclic athara.  Significant MM uaaa
arai protection In th* Morkplaca; haiard cnoamlcatlon
pregran; Induatrlal. coMarclal, A conauMr actlvltlaa; A
dlipoaal.
                                                                     20
                                                                            (06/50/90)
-------
        NAME
•me   or
       0«
           PROPOSED     PROPOSED     flHAl Ullf    HUM. HUE
 40 CM     IDLE        MILE fl         fl         PUIIISH   EffECIIVE
C|l«IIOtl	"II	CIIMION      CIUIION      OMI       0*li
                                                                                                                    •PIES.
      P-8S-369
      p-as-167
      •-BS-UII
      P-87-126S
      P-87-304
      •-8S-MS
      •-85-680
      •-86-U9)
721.1078
721. IOW
721. U60
                                       721.I46S
                                       721. UM
                                       721.1542
                                       721. ISM
                                       721.1S6S
HONE
                      NONE
                      HONE
                      HONE
              SS fl 26102   06/26/90  06/27/90
              SS  II 26102   06/26/90  08/27/90
SS fl 26102  06/26/90   08/27/90
                                    SS fl 26102   06/26/90   08/27/90
              SS fl 26102   06/26/90   08/27/90
              SS fl 26102   06/26/90   08/27/90
                                    SS fl 26102  06/26/90   08/27/90
              SS fl 26102   06/26/90   08/27/90
      (••84-820
                                       721.1608
                                                              HONE
                                                                           SS fl 26102   06/26/90  08/27/90
Ntloalkyl  •Uatltutcd cyclic •thtrt.  Significant new IMM
•re: protection In th« norkplK«; haiard coooufilcatlan
progrca;  IntuttrUl, CMMfcUl, i corxuaer Mtlvltlct; i
dikpo*«l.
H»lo«Url  •Uwlllutad cyclic •tliir.  Significant neM uses
•re: protection In tho workplace; heiard comunicatlon
prograa;  InduttrUI, coNHrcUl, 4 coniuner activities; I
Haptitbalen*.  1.2,S.4-t«trehydro(1-phtnylethyl).  Stgnlflceni
MM use* are: haiard coMuilcatlon progrwi;  InduatrUI.
cotnercUI. i conauMr Ktlvltles; dlipoMl; i releate to
Meter.
2-Haplithal«necarbo*Mild(-N-aryl-l-hyoVo«y-4-aryloio (generli
mae).  Significant  ran u*e> aret protection In  the
ncrkplMa; haiard conuilcatlon program; A Induatrlal,
ccsvercUl, A comuMr •ctlwllloi.
•ItrotblopltenecartoHyllc acid, athyl eater, blallll
CtiiMtltuted)|Mlr»)«Uylphenyl|aio| (generic neno).
Significant nan uaaa arai Induatrlal. cooMrclal. A conuaHi
actlwltlee.
trlititetltuted  phenol (generic MM).  Significant  nan ueee
are: protection In tha workplace; baierd conutlcatlon
progran; A  Industrial, coHaerclal. A coraiaar activities.
1,t-OiMthylpropyl paroiyattar (generic nssv).   Significant
MM uses arai pfotectlon In the workplace; haiard
coMMilcatlon prograsi; Industrial. coMsarclal. A consuaer
activities; A disposal.
Sutetltutad alkyl pero«vhe»ene csrboxylata (a>Uad (sonars)
(generic naae). 'Significant nen uses arat protection In th«
Morkplace; haiard cosauilcatlon prograsi; Industrial,
conacre I el, A consuaer activities; disposal] A ralaasa to
Miter.
PhosphoMua aalt (generic na*e).  Significant nan uses arai
protection  In tha workplace; haiard ceasBailcatlon prograa;
i Induatrlal, cooMrclal, A cenauaer aetlvltUa.
                                                                        21
                                                                                                                     (06/10/90)
-------
MIIE

MAKE
of mat
ot fm «
f-M-61
40 CM
ciurioM

NOPOSCD
•WE
OME

FIOPQSEO
tULE ft
cir*f|o(
•ONE
HUM. «UE
n
CtUllOH
»S H 26102
flMAL lUlf
rutusit
DklE
06/26/W
EfffCIIVf
DAIE HOTEi
M/2r/W tutetliutwl UtlMlno hydrulnt Mlt (t«n*rtc OMM).
                                                                                                         HM WM •?•! proltctton In UM
                                                                                              hucrd CCMU>|cation progria; Industrltl, co
                                                                                              coMuncr KllvitUtr I 4t»pot*K
F-BM4S6                      ni.2500             WME         1$ fl 26102   06/2A/90  U/27/M  folyMln* urMtanMlMifdi 
-------
MJIE
CODE
 NAME
Of RULE
oa cm i
 «o en
CIUIIOH
PROPOSED
 MIIE
 DME
PROPOSIO
RULE fa
ClfMIOH
HHAI IULE
   it
 CIUIIOM
HNAl IUIE
  PU8USH  EffECIIVE
   OMEOMI
                                                                                                                     MOIjS
•rllO List of hasardous substances u
           104(1
      HOIE r« irllO
                                •rllO HOIE
                                    si fa ua66  ot/ir/ar
                                    $2 » UI40  09/IS/87

                                    SI fB 51192  12/20/66

                                    SI II 412M  IO/20/aa
                                    SI !• 48614  12/OI/U
                                    S4 fl 14017  04/06/89

                                    S4 fa I4I9S  04/11/89

                                    S4 fB 26417  06/21/89

                      •rllO HOIE    ifMO HOIE
                                                           first  lltl of 100 hucrdoui nteltncti.
                                                           Hot let of Availability • la*lcaloajcal »rofll«*i (Priority
                                                           Cr*<>  11.
                                                           Hotie* of ^vallablllcy • lulcoloojcat f>rofll«t (Priority
                                                           Cr«v  2).
                                                           Second lltt of 100 haiardoua aitetancei.
                                                           Cofr*ctlon.
                                                           • aiotlc* of Availability • final version* of foilcologlcsl
                                                           Profile* (for S eUbstsnces).
                                                           [mention of COHMM fMrlod for draft toilcoioglcel
                                                           Profiles.
                                                           • 4otlc« of Availability • final versions of loalcologlcal
                                                           Profllai (for S fcAwtances).
                                                           these  citations raftr to tha list of haiardoua aiAatancaa
                                                           uidcr  section 104(1) of tha Comprehensive Envlionnenlel
                                                           Bciponse. Coociensatlon. and liability Act (CEBCLA or
                                                                                 by SAM section 110.
                                                                        21
                                                                                                              (06/10/90)
-------
NAME PROPOSED
MAE Of MILE 40 CfR MAE
CODE OR PNN • CIIAIION OAIE
•rill LUt of tMic chnlcali under ' 02/04/67
111 of the 01/2S/67
07/20/87
oi/19/aa
06/04/87
04/12/88
06/2o/aa
WOT/SB
02/17/69
172 04/21/89
AlusinuM oilde; toalc Cheat eel 1/2.65 04/24/69
till of to*ic choislcaU uvtor 0»/IS/89
MOIE rn «rin trill NOiE
172
PROPOSED
RULE fR
CIIAIION
S2 fR 147V
H fR 9U6
J2 fR 27226
SI fR SOUS
J2 fR 2IIS2
SI fR 1201*
SI fR 21128
SI fR 49661
S4 fR 7217
14 ia 16116
S4 fR 16176
14 fR 20666
•rill NOIE
flMAL RULE
fR
CIIAIION
SI fR 21108
SI fR 4SOO
SI fR 12748
SI fR 19474
S4 fR 12912
S4 fR SI298
S4 fR 25650
S4 H 49946
SS fR 5220
•rill NOIE
S4 fR 42962
S4 fR 45691
flHAl RULE
PUBLISH
OAIE
06/20/88
02/16/87
04/18/88
10/07/88
01/29/89
12/14/89
06/20/69
12/01/69
02/14/90
10/19/89
10/11/89
EffECIIVE
OAIE HOIES
Stftteaeot of Policy and Guidance regarding petition*.
technical ssHraaBsnt to odd categories.
• Proposed roMval of Rutyl phthalata.
06/20/86 • Rcowal of lltanlui dloalds.
loilc Chomlcal Ralaaao Reporting; Consunlty RlgM-lo-KnoM.
Coirtctlon.
10/07/86 • Rcooral of Acid 6luo 9.
01/29/69 • Rawval of NalMlra.
12/14/89 Prcfotod dilation of todlin hydro*!* (solution) fro* 40 Cf»
wctlon 172.6$; delation dMlalon flnallted and Sodlua
bydroildt (•olutlen) raamod from 40 CfR aactlon 172.6S(a| 1
CAt HO. 1110- 71-1 rowwod fra 40 CfR aactlon 172.65(0).
HOIE: CAS Ho. ontry aUo rowvtd fr« CORR CAS No. Hat.
06/20/69 • Rcwwal of Sodlia aulfato (aolutlon).
12/01/69 "• Propo*«d •ddltlon of certain diaalcaU; •ddltlon pi
OUthylomlno (CAS M. 109-69-7) la ponding until
fur mar analyala of • 1986 NIOSM ttudy (Lynch «t al.)
la ce«plotad.
02/14/90 • Propoaad raoaval of Aluilnw Midi, final rule -
deletes non-f Ibroua foraa of Alualiua oxide •• CAS No.
lia-26-1 •- fr« tho Hat of toilc chealcala. f Ibroua
form of Aluelrua oalde Hill raaaln Hated, and ralaaea
reporting nil! continue to bo raojilrad for fibrous fore*.
• Proposed OMoptlon for CAS Noa. 147-14-8. 1128-S1-6.
and. 14102-11-7 frcej report (no raojulraoenta under
category "Copper coapounds."
lluiae cltatlona, rafar to the Hat of teilc chealcala undsr
aactlon 111 of the Emergency Planning and Coaautlty
Rlqhl-to-KnoM Act (EPCRA or SARA lltlo III).
10/11/69 Dental of petition to dellat Cadilue aulflda (CdS) and
Cefoiue aalonlda (CdSe)) denial baaed on Height of ovldmca
deteralnatlon.
HOIE i Effective Oato of tola denial petition la 10/11/89.
uhlch la tho Statutory Deadline for EPA'a response.
10/11/69 Correction; CaoMua Sulf Ida and Cadalua Solanlda.
24
                                              (06/10/90)
-------

RULE
cqpi

NAME
Of RULE
ORPNM*


40 Cll
CITATION
172
PROPOSED
IULE
OA1E

PROPOSED
•ULE II
CIIA1IOM

IIHAL RULE
II
CIIAIIOH
S4 II 46424
IIHAL RULE
PUBLISH
DAIE
11/01/89

EIIECIIVE
DAIE HOIES
11/01/89 Denis! ol petition to delltl Decebrooi



•tlphenyl ether (DIOPI
Change el Address Hollco lor I    ISO. 16
                                     SS II 420    01/01/90   Ot/01/VO
Chroae Ant loony lltenlua lull
372
                                                                       SS II MO     01/06/90   12/24/A9
Bert us Sullele; foslc Chemical


Antimony 1rlt(lso-0ctyl Hercep
172.6S    02/12/90
                                  S/2
                                                         Si II 467*
                                     SS II $010   02/II/M   01/01/90
lereptithollc Acid; toxic Cheat    172.6S    02/1S/90     SS II S472
line lor«t« Hydrata; f«lc Ch«
172
                                                                       SS II 10214   01/20/90  01/10/90
Oione Oepltting CheeilcaU; TM    172
• •..   .- t.'ftir f Solution); I
)72
          01/21/90
                                            01/10/90
                                                         SS II 10471
                                                         SS II 12141
beted an weight ol evidence ol dtvelopnentel «nd chronic
toiicologlcal allects In huHna.
lechnlcal omendmint; llnel rule.   Hw oddreta Is:
 lltle III ReportIng Center
 Environmental Protection Agency
 P.O. go* 221779
 Ueshlngton. DC 20026-1779
Denlel of petition lo accept Chrooe Antimony lltenlua Dull
But lie (CAIBI) Iras reporting under cotegorloe "chromium
compounds" end •antimony compounds."  Denlel based on
determination that CAIBR Is • potential carcinogen end on
evidence ol carclnsgenlctly (chrcm./cart. chram. compoundsi
Proposed rule - lo grant petitions le eiempt bar tut sullet*
from the reporting retirements under the category •barlui

Denial el petition to dtlele Antimony trlsdso-octyl
merceptoecetate) •• efcoi AION (CAS No. 27280-44-41 •- Ircm
the list ol to«lc chemlcale.  Human health concerns beted .
•ntlmony end antimony compounds.   Concerns Include:
corclnagenlclty. end developmental end reproductive ellecli
Proposed rule - to grant petition to remove lerephthallc
•eld Iron the Hat ol loalc substances.  Css No. 100-21-0
vould be removed.
Denial ol petition to delete 2lne borete hydrate (ZO-211S)
Ircm the 11 at ot ta»le subttences. Beted on evidence that
the chemical can be reasonably anticipated toi be to«lc to
aquatic organisms and cause developmental end reproductive
effects In humane.  Cos Ho. 12S11-27-0 Is 18-2315.
« Notice ol receipt el petition lo odd •oven oione deplelli
chomlcels to the list of tetlc substances.  Spoc'flc CAS
Hot. Mould Include: 75-69-4. 75-71-0. 76-14-2. 76-1J-1,
421-01-2. 75-61-0. end 124-H-2.
Proposed rule - to delata Ammonium sullate (solution) from
the list ol toilc chemlcale because releeses can be more
effectively covered by the ammonia listing. CAS Ho. entry
7781-20-2 Mould also be removed.  II llnellied.
                                                                                                                 (06/10/90)
-------
lULf
CODE

HAKE
Of MAE
m em *
Change of Address Notice; Corr
40 CH
CIIMtM

PROPOSED
Will
DAIE

paoposEO
•we ft
CIU1ION
HCTd
fINAL UM.E
II
CITA1ION
» fl 1926*
FINAL MM
MULISH
OAIE
OS/09/90
EffECUVE
OME
OS/09/90
NOTES
Corrccle change of

address nolle* pi>U»h«d In th« fcdertl
Sulfurlc Acid; lojilc
                                 IK
                                                       OA OI/M/M <5J ft 420>.  P.O. IOA
                                              MA Cncorr«ct; cornet P.O. tw  U 21FI9.
             H fl 244J7   06/1B/M   06/tl/M  DtnUI of ptlltlon to dtloto Sulfurlc ocld froa tht (lit of
                                              toalc chwIcaU.  PcnUI U bMotf on th« conclusion thtt
Phosphortc Acid; loilc Choilco    172
06/25/90
iS fl 2U7*
                                                                                                     •ullurle ocld U roMorably antlclpotod to cautt
                                                                                                     chronic ki»Ub effect*.  IMO pttltlont wtro flirt on 12/12/t
                                                                                                     A 03/07/90.   NOIii lff*ctl«o Oat* U •Ututory dttdttn* ft
                                                                                                     CPA't Mftponit to tit* pot 1 1 Ion.
                                                                                                     Hot let Uiulnf tht retulU of • technical rtvltw and
                                                                                                     t¥*(uatlon of • petition to etolttt PhMftiortc Acid (PA).
                                                                                                     Alao. IPA U reqjettlna  public coMtnt on tht devtlopnent i
                                                                                                     • pliotphatt category udar ttctlon 113, i*lch would Inclucfc
                                                                                                     P*.  M well ae other aourcet of phoiepliatt.   PA, beceua* t>
                                                                                                     lie corroelvt proper I let. can cauee anderatt  acute loxlcltt
                                                                                                     Ir huMna; but, not anticipated to cauao chronic toxlclty >
                                                                                                     hunana.  PA can rta»ombly be anticipated to  cauaa-
                                                                                                     onvlronMntal toalc I ty and contributes to phosphate loadlm
                                                                                                     Petition tut MlthdrtMn 06/01/90.
                                                                                                             (06/10/90)
-------
NAME
MILE Of IULE
CODE M PNN 0
tl 1CEA



t2 Ethyl toluenaa. frleathylbenie
nee ft C9t



tl OEIA


PIOPOSEO
40 Cfl IULE
CIIAIION OAIE
799.4400 06/05/81

08/07/65
799.5000
799.2175 05/21/81


01/27/66

799.1575 04/29/82

799.1575 06/26/69
PIOPOSEO
MILE fl
CIIAIION
46

50

46


SI

47

54
fl

fl

fl


fl

fl

fl
10UO

11895

21068


10557

18186

27189
flMAL lULf
fl
CIIAflOH
49

SO
54
50


52
54
50

55
fl

fl
fl
fl


fl
fl
fl

fl
19810

51661
14991
20662


2522
27152
21198

1407
flHAL MAE
PUBLISN
OAIE
10/10/64

12/19/65
08/21/69
05/17/65


01/21/87
06/29/69
05/21/65

02/01/90
EffECIIVE
DAIE
11/21/64

02/01/66
08/21/69
07/01/65


01/09/67
06/29/69
07/06/85

01/19/90
HOIES
1.1,1-Irlchloroethane; developoental toilclty ft
envlronaental effecta.
Phaae II rula.




I til Ing Content Order - eutogenlclty ft neurotoklclty.
Hturotoilclly. autagenlclly. dtveloptcniel .toxlclty.
reproductive affacta ft oncogenlclty (unlett certain
•utaganlclly teat raaulta are negative).
Pheaa II rula.
technical aaendMnt.




Olethyleneirlaailna; oral aubchrenlc. darnel abaorptlon.
chealcal fata ft autaganlclty.
Propoied rule • eitenelon of deadline ft raclalon of

deravl
abaarptlon tatting, final rula • reclalon of derawl
abtorptlon tilling and eitenelon of deadline for tutanliiloi





t4 Olphenyl


tS Propylano oalde

16 Nealtyl onlde (NO)




04/10/66
799.1575 05/21/65


799.925 05/21/61
07/15/66

799,1450 01/04/84
11/27/65
799.2500 07/05/61


12/20/85

51
50


49
SI

49
50
46


SO

fl
fl


fl
fl

fl
fl
fl


fl

I2U4
21411


21080
25577

410
46801
11812


51866

52
55

54
SO
52
54
SO
52
SO

52
52

fl
fl

fl
fl
fl
fl
fl
fl
fl

fl
fl

1210
17769

27152
17182
20710
27152
46762
15706
51657

10752
19068

02/01/87
04/27/90

06/29/69
09/12/65
06/01/67
06/29/69
11/27/65
09/21/67
12/20/65

04/01/87
05/20/87

01/19/67
04/19/90

06/29/69
10/28/85
07/17/67
06/29/89
01/10/86
11/06/67
02/01/66


07/06/67
of final report on chealcal fato teat Ing.
Phata II rula.
Oncogcnlclly tatting; aropoaad rule, ylthdraual of
rula became cheat cat la not eutagenlc.
technical aa*nd»tnt.
Environmental affecta ft chealcal fata.
Phata II rule.
technical tatndMnt.
Oavalopntntal toalclty.
letting atandardt ft reporting roojulreawtta.
Subchronlc Inhalation, autagenlclty ft oncogenlclty
eutegenlclty reaulta are poaltlve).
Clarification of final rula.
let! atandtrda ft reporting reojilreamta.


propoac







(If



17    Nydroqulnone
                                         799.2200    01/04/64   49 fl 418     50 fl 51145   12/10/85   02/12/66
loilcoklnetlct. central narvoua ayatta). reproductive effec<
ft terategenlc effecta.
                                                                          27
                                                                                                                         (06/10/90)
-------
NAME
MILE Of IULE 40 CM
CODE Of) FWN • CITATION


18 Certain Chlorinated Benienea 199.
799.
t9 Creaoli 799.


tlO Certain Chlorinated Benunei 799.
799.
799.
799.


799.
799.

799.
799.



1052
10*1
I2SO


lost
10S2
IMS
IMt


10S2
10S4

10S4
IOS4

raoposED
MAE
OAIE
12/io/BS

01/11/64
M/07/M
07/n/ei
04/26/66

07/ia/u



12/20/64
n/27/es






raorasED HNAI tun
KM H fl
CIUIION C|TATIOH
SO H SUM SO
94
49 fl 17M SI
SI H 1I7S6 SI
48 H SI8I2 SI
SI fl 1S80I SI
S4
4S ft 48S24 SI



49 fl 10408
SO 18 48806
S2
S2

S4
52

fl
IB
ri
ft
ft
H
H
fi



I986S
27IS2
11728
24460
IS77I
19082
271S2
24637



HHAl 8UIE
MOLIU
OAIE
OS/28/87
06/29/89
04/07/86
07/01/87
04/28/86
OS/20/87
06/29/89
07/08/86



EffECtlVE
OAIE
06/11/87
86/29/89
OS/21/86
08/14/87
06/11/86
07/06/87
06/29/89
08/21/86



HUES
feat aiandarda 8 reporting reojilrea«nti.
Technical enendatnt.
Ofcdlorcbententa; emlromental affectt 6
Trlchlorcbenicnea; Mwaa II rule.






chejalcal fata.


Nutagenlclty. davelopMntet tMlclly 1 reproductive etfec1
Phaie II rule.
lecanlcal aMndaent.
Monochlorobenianaa; reproductive effecia.
Olcblorobentenea; reproductive effect*.
Irlcfilorobenienaa; oncoaanlcliy.
1,2,4.S-latraclilorobentana; davetopnantal










toilclty.
UUhdraiMl of certain for tl ana at propoeed nil*.

fl
fl

fl
fl


10177
26477

27M2
10177


04/01/87
07/IS/87

06/29/19
04/01/87


04/01/87
07/1S/87

06/29/89
04/01/87

•evlalon of proposed nil* to reflect ISC*
teat outdollnta
eUtkloretMruame; codification af reporting
1.2.4.S-leiracMoroboniom; oodlf Icatlen of
purity reo>jlraMnt.
1.2.4.S-letrachlorofaeniene; technical ane
«,2,4,S-1etrachlorobeiuen*; •odlflcatlon
deedllnaa.

ml
of

daadtlnea.
.teat eitetanc

aent.
rcporttng

til   1.2-Olchtoropropam
t12   Blaphanol  A

til   2-Ethylhe«anolc acid
                                    $4 fl 27U2   06/29/89   06/29/89 technical
799.1SSO    01/06/84   49 fl 899     SI fl S2079   09/09/86   10/21/86 Hrurotulclty. autagcnlclty.  reproductive effect*.
                                                                      devclopMnlal loalclty. acute tailclly 8 chronic loxlclly
            09/09/86   SI fl 12107   92 fl 17118   10/OS/87   11/18/87 PhanMcaklnaUc6 t ait Ing etendarda.

799.940     OS/I7/8S   SO fl 20691   St fl 11047   09/18/86   11/01/86 SiAchronlc Inhalation.

799.16SO    OS/17/8S   SO fl 20678   91 fl 40118   11/06/86            Sutchronlc tulclty. davatopBcntal toilclty 8
                                                                      ptianMcaklnatlca.
                                    S2 fl 241S7   06/29/87   06/29/87 Technical andlflcatlon.
                                    S2 fl 12240   08/26/17            Correction.
                                                                        28
                                                                                                                      (06/lo. .
-------
NAME
RUE Of MAE
CODE O> PNM •
tU Cycloheiane

US Anthrao>jlnona




t16 Bemyl butyl phthalalo

117 Chloronethene

tIB Cuaene
119 Olethylena glycol butyl ether/
•cetata







t20 1.1-Olchloroothyleno
t2l Dtchloronethene

PROPOSED
40 CM RULE
CUM ION OAIE
os/20/87
07/27/67
06/07/89
799.500 11/06/85




09/06/8}
10/29/07
07/1S/BO
05/07/os
799.1285 11/06/05
799.1560 08/04/86


05/11/89

795.225

799.1560

08/12/86
06/05/81
06/19/84
PROPOSED
RULE ra
CIUIIOM
Si 18 19096
52 fR 28021
54 fB 24160
SO fa 46090




SO f8 16446
52 IB 4IS91
45 fB 48524
SO fB 19211
SO fB 46104
SI fB 27880


54 fB 11202





SI fB 28840
46 fB 10100
49 fB 25009
HUM. ami
ra
CIIAIION


52 fB 21018


52 fB 12990
54 fB 27152

Ullhdroiial

Withdrawal
SI fB 28195
SI fB S912



54 fB 27152
54 fB 41812

54 fB 41812



Withdrawal
flNAL RUE
PUBLISH EffCCtlVE
OAIE DAIE HOIES
Subchronlc toalclty. oncoganlclty, (••productive to«lclty,
dtvtlopMiiUl tMlclty. Murotulclty. dtraai cbtorptlon 1
dcrMl •ml I (Milan.
Proposed rult; ••tension of caMnt period.
Beoptnlng of conent period.
06/04/87 07/20/87 Veter •olublllty. blocancentrellon, ecute tmlclty to
tajtutlc orgenliM, blodtgredetlon 8 chronic tMlclty to
•ajMtlc oroMlMB Clf triggered).
09/01/87 Correction.
06/29/89 06/29/89 technical wndMnt.
EmlronMntel Ut« 8 •ffecle.
UlthdroMol of prepoeed rule.
Heellb •fleet*.
Ulthdreiwl of propooed rule.
07/27/88 09/09/88 Heelth •llecu. emlronMntal «Mectt 8 chotlMl fata.
02/26/88 04/11/88 plathylene glycol butyl ether COCBE) 8 Olethylene glycol
butyl ether ecetete (OG8A); •utehronlc loalclly for DUE 1
derMl absorption for OCBA.
Proposed andlf Icatlon to final rule.
06/29/89 06/29/89 lechnlcel aeepdnint.
10/12/89 11/27/89 nevlalng the dose occlusion reojjlre*Knta for denaal
pharewcoklnetlca teat Ing for OGBE and DMA.
10/12/89 11/27/89 Modifying the autalaalon of progress and final
pharaecoklnetlc'a teat reporta to EPA.
Oerswf 6 oncogenlclty bloaaaay.
Heelth 8 amtronaental effects.
Hlthdreual of proposed rule.
29
(06/10/90)
-------
        DANE
RULE   Of RULE
coot   oa pun §
                                        40 CM
          PIOPOSED
           RULE
           0*11
           PROPOSED
           RULE ft
           CIKIIOH
              flHAl IUU
                IR
rmu  RULE
  PU81IU
   0*11
                                                                                                  EffECIIVC
                                                                                                    PAIE
121   2-ElhylhtMiwt
121   fluoroelkenea
199. IMS    12/19/66   SI fR 4)487   S2  »R 26698   06/01/67  09/16/67  Oncogentclly bloaaaay.
799.1700    1I/06/6S   SO fR 46111
                                       799.1700    12/21/66   SI fR SI847
                        S2 fR 21416
                        S2 fR 26962

                        S2 fR (1762
                        Si fR 273S2
                        SS fR 12619
                           06/06/67
                           07/17/67

                           11/16/67
                           06/29/69
                           M/tt/90
           07/22/67
                                                           06/29/69
                                                           OS/21/90
124   MeMfluoropropylena Midi
125   2-Nercaptobeniothlaiole
799.21SO
12/10/61
10/14/66
46 fR S7666
SI fR 40244
126   Comnerclal He«ane 6 Netbylcycl
      opentane
799.247S    1I/06/6S   SO fR 46121   S] fR  14114   09/07/66   10/21/66
                                                                          SI fR 17191   09/26/66
799.2ISS   OS/1S/66   SI fR I76S4   SS fR 1182    02/OS/6S   01/21/86
                                                  07/21/66
                                                  OS/27/86
                                       79$ 6 799   11/09/88
                                                             St fR 26170
                                                             SI fR 1911S
                                                             SI fR 4S269
                                    SI fR I69S2
                                    SS fR 627
                                      10/04/66
                                      01/08/90
                                      11/17/88
                                      02/21/90
                                       799.21SS
t27   Nltrobeniene
            12/09/68
            12/21/88
            06/K/61
            06/19/84
           SI fR 49822
           SI fR S1647
           46 fR  10100
           49 fR  2S011
              SS  fR  12619   04/OS/90  OS/21/90
                                                                                                           Health •IttCU.
                                                                                                           Corrtcllon of final  rulaj  Insertion of  Inadvertently oaltte-
                     Icflmlccl McndMnt to flml rult.
                     Itchnlccl totmtetnt.
                     •wntant to th« rw^iUtwnt tor  th» Mouta VUtblo Speedtc
                     lorut U»t (HVUI to lUoM oltlMr tha mil or the Nome
                     Olocheitcol Spoclflc Locuo !••( (NISI).

                     (IPO; carcinogenic I ty. autegenlclty i raproductlva afltcia.
                     laralnallon of rulaMklng.

                     feraletenca 6 •ability, chronic aopatlc tralclty,
                     pharaacoklnatlca, chvalapMnlal loiklty, roproductlwa
                     to*Icily, murotMlclty 6 chreaoaa*al aberration*.
                     final rulo; corracllon.

                     Conmrclal Haaano - health affacli;
                      • Nathylcyclopantana • lamination of rulcawklng.
                     rrapoted rule; aitanelon of caavant period.
                     Oeflnltlon of taat attetanca 6 affective data.
                     Proposed rule; propoaad pheraacotlnetlci taat requlrcncnta
                     and ravlalon of propoaad teat guldellnaa.  final rule;
                     40 CfR TVS.212 - Inhalation and diraal pkanwcoklnetlca of
                     coanarclal neiene and 40 CfR 799.21SS • Connerclcl heiena.
                     Thla rulo eevnte final taat rule  • SI fR IS82 (02/OS/66).
                     Correction.
                     taentent to the raojulraaml for  the Nouta Vlelbla (pacific
                     locua laat (MVU) to alloM use of either the NWtL or the
                     NOUH llochevlcat Specific locua  laat (MSI).

                     Health 6 envlronaento! effects.
                     Uitbdraiial of propoaed rule.
                                                                       10
                                                                                                                    (06/10/90)
-------
DANE
BUtE Of BULE
CODE OB PNN f
t28 Octaaethylcyclotstrsslloiane

t29 Olsylaaina






tlO Pentabroaoethylbeniens

til Polyhalogeneted dfbenio-p-dioa
Ins/fur ana


t!2 Ouinons

PBOPOSCO
40 CfB BULE
CIIAIIOH DATE
10/10/85
799.5000

799.1175 11/19/84


08/24/87
799.1175 12/21/88


11/11/85
11/22/88
766.25 12/19/85


10/21/86
01/04/84
I2/M/8S
PBOPOSCO
BULE fB
CJIAIIOH
50

49


52
51


SO
51
SO


SI
49
SO
fa

fB


fa
fa


ra
fa
fB


fa
fB
fB
45121

45610


11970
51847


46785
47228
51794


17612
456
S1I6S
flNAl IUIC
fB
CIIAIIOH
54 fB
54 fB
52 fB

52 fa
51 fa
55 fa


818
1181
11962

17246
48542
12619


MNAl BULE
PUBLISH CffCCIIVC
DAIE OAIE HOI ft


ChMlcol fats 8 environmental affects.
01/10/89 01/10/89 Consent Ordsr • cheoJcal fats and environmental affects.
01/21/89 Correction.
08/24/87 10/07/87 ftutagsnlclty a developments!
oncogen snd outogen).
10/05/87 Correction.
12/01/88 01/17/89 Phese II rulo.
04/05/90 05/21/90 Anendment to the reojilrsoent
locus lest (NVSL) to alloM tl
House 8lechoolcol Specific Ic

toalclty (If triggered es M




i



for the House Visible Specif 1
to use of either the HVSL or
KUS ISSt (NBSl).
t

Chsailcal fats 8 environmental of facts.
Mlthdr
52 fB



anal
21412



VlthdroMel of prepoaed rule.


06/05/87 07/06/87 lasting for presence of certoln chlorinated 8 bromlneied
dlMlns 8 furanaj • CM Bos.
In final rule.
loandwent to proposed rule.
94-75-7 8 94-82-6 • ulthdretti




Carclnogenlclty. onvlronBsnts! offsets 8 chsalcsl fata.
Ullhdrsuat
fclthdrausl of prepoaed rulo.


til   lotrobroMblsphwiol A
t!4   Irlsthylons glycol oonoMthyl
      othsr
tlS   Solid Ussto Chemicsls
799.4000    OS/1S/86  51 IB 17872
                                                 08/19/87 Chcalcsl fsto snd onvlranssntsl offsets.
                                                 06/29/89 Isehnlcsl
799.4440
OS/1S/86

12/09/88
SI fa 17881

51 ft 49822
              52 IB 25219   07/06/87
              54 fB 27152   06/29/89
54 fB 11472   04/01/89   05/17/89  IGMC; dsvslopMntol tMlclty 8 nsurotoilclty.
799.5055    05/29/87  52 fB 20116
                                                                            54 fB 11470  04/01/89

                                                                            51 fB 22100  06/15/88
                                  Correction.
                        04/01/89  Isstlni Consent Order • hesltb offsets.

                        07/29/88  Kssllb offsets and/or ehsalcsl fsts;
                                     • Withdrawn from final rulo without rscoBMndsd tasting
                                        at thla tlaa;
                                    •• UMhdraim fro* final rulo ultk rocoMendtd testing.
                                                                        II
                                                                              (06/10/90)
-------
RIM
COOf

NAME
Of RUE
OR PNN •


PROPOSED
40 OR RlAi
CUM ION DAIE
08/07/07
oa/12/87
oi/u/aa
PROPOSED
IUII fl
CUM ION
$2 fl 2919S
SI fl 29990
si fi 9ti
fINAl RUIE
fl
CUM ION

HHAl RULE
Mil ISM
OME

fffCCIIVE
PMC BOIES
Proposed
Proposed
Proposed
ruU;
tuUj
tulo;
extension of can
corrections.
reopening of CM
KOI period.
sent period.
                                        799.5055
                                                                            SI fl 4864S   12/02/84   12/02/88
                                    S4 fl 49760   12/01/19   12/01/09
                                                ••• lew «l of Pfethollc anhydride (CM do. 85*44-9) fro»
                                                     tMlIno reojilro»enti.
                                                technical Memfamt; CORRECI CM niter for hoierdous Meets
                                                constituent •- IrlchloroMlhonethlol  •• Is 75-70-7. HOI US
                                                Mo. 594-42-1.
156   UMubstttuted PhtnylcntdlMlno    799.1100    01/06/06   SI fl 472     S4  fl 4920S   11/10/09
t!7   OCIIf
tia   OIIP
                                         799.1)00
                                        799.SOOO
            01/14/M
            u/21/aa
S> »R 911
SI fl S1047
SS fl 12619   04/05/90   OS/21/90
01/16/90  lUnufocturoro 8 processors of o-POA (US Ho. 95-J4-J), m-PO
          (US do.  108-4S-2) p-POA (US Ho. 106-SO-I) ond sulfoio
          suitsl ••PO«.(H)2 S(0)4 (US No. S4l-70-OI/p-PO*.(N)2 S(0)4
          (CAS Ho.  1624S-77-S) • Nouroloilclly,  Chosilcol foto. Aojuatl
          ttMlclty; N/P of «-POA A Its tulfots sslt • Nutogenlclty.
          Proposed rulo; reopening of ceeewnt period.
          AMndaent to tho rooplroemit for the Nouee Visible Specific
          locue test  (NVSl) to ollon test sponsors to use either tho
          NVSl or  tho Mouse Olochealcel Specific IOCM  loot (NISI).
                                    S2 fl 21S47   06/21/07   06/21/07
                                                                            S2 fl  12990   09/01/07
t!9   Tributyl phosphele

      Irlbutyl Phosphote; flnsl  lost     TVS.220
            06/2S/07   S2 fl 21062
799.4160    11/12/87   S2 fl 41147
              S4 fl 11400
              S4 fl 49844
              SS fl 2S192
              OB/I4/B9
              12/01/89
              06/21/90
09/27/89
12/01/09
06/21/90
140   leopropsnol
                                        795 4  799   01/16/08   SI fl 0610    54 fl 41252    10/21/09   12/04/09
1,4-Olchlorebeniotrlflueride; testing Consent Order -
chenlcol folo A envlroneentel effecle.
CurroctIon.

2.6-OI-tert-butyl  phenol; chealcol foto I omlronnentel
etfccto.

Chealcol fete/tieollh offocto 8 envlroneentel offocte.
Correction;  flml  rulo.
Correction;  flnel  rulo.

40 Cfl 795.211  - Pherswcoklnetlce of leopropono! end 40 Cfl
799.212S - Isopropenol.  testing Included •ubchronlc
toiiclty. reproductive toilclty. dsvolopMniol toilclty.
neurotoilclty,  developnentel neurotwlclly, sutogenlclty.
oncogenlclty, end  ptieneecoklnetlcs.
                                                                        12
                                                                              (06/10/90)
-------
        MANE
•me   or MJLE
CODE   01 PMM •
 40 Cfl
CHAIIOM
PROPOSED
 •ULE
 OAli
PIOPOSED
lUE »
ClIAtIOM
flNAL IUIE
   fl
 CIIAIIOH
flHAl IUIE
  PUBLISH  EirCCUVE
   OAIE       DAIE
                                                                                                                     BOIES
            04/10/88   SI II  12748
799.212S    12/21/88   SI II  51547   SS II 12619   04/05/90
                                                                                                             Correction; proposed nil*.
                                                                                                    OS/21/90  Anentent to the reojilroMnt  lor th« Nouta viable Specific
                                                                                                             locus let: (NVSL) to alloM use •! titter tht M|SL or the
                                                                                                             Nouao nlr-hwlcol Spoclflc lotus last (NISI).
t41   Itolhyl tort-butyl •thtr

142   Aniline 8 itwm Substituted An
      11 IMS
141   Methyl ethyl ketotlM
144   AUyl  phthslstes
      final  lute;  technical
799.5000
799.5000
                         S! M 10191   01/11/51   01/11/U  lasting Consant Ordsr  • Mallb •ffacts.

                         SI II 11804   OB/I9/U   OI/19/aa  Itstlna Consant Ordar  • kasllh t anvlrorwental tllacts.
                                                                            si ii  imi   09/26/aa
                                                                            si ii  499o*   »/»/aa
                                                                      lasting Consant Ordar • correction.
                                                                      lasting Consent Ordar • correction.
799.2700
                                        799.SOOO
799.SOOO
 09/IS/5B   SI II ISAM   S4 II 17799   09/ll/69  10/27/09  M£KO; haaltk allacts.
                         S4 II 49544   12/01/59  12/01/59  Correction.
                                    S4 II Aia     01/09/69   01/09/89
                         S4 II 1151
                         S4 II 4109
                         SS II 1055
                          01/21/59
                          01/27/59
                          01/10/90
                        01/10/90
                                        799.S02S
                                    SS II 1055    01/10/90   01/10/90
                     listing Consent Ordsr  • chsalcel lets A onvlrenaantet
                      effects.
                     Correction.
                     Correction.
                     • moves Incorrect description of one of test •(•lures  —
                     Oilhepiyl. nonyl. undecyl) phthelote (alied Isoasrs) •- CA:
                     •4. 65515-42-4. Cnsngee title tot "lestlng Consant Ordsre
                     fir tubetances end Mlttures with Cnseilcel Abstract Service
                     •tglstry Mwcwre." CAS Mo. 655IS-42-4 nan roaovod fro* COM
                     Eitebllshee  neW section for aUtures subject to testing
                     Canaan: orders.   Adds  correct description to be testadi CA!
                     IH. 6551S-44-0. CAS Mo. 65SIS-4S-7. CAS No. 111151-59-6, tl
                     Mi. 1645-20-2. CAS Mo. 111151-90-9. end CAS Mo. 1M15I-9M
                     lust siUturei  OKbcptyl. nenyl. undecyl) phtbelete (0711P)
t4S   Ollsodecyl  pbenyl  phosphite

t46   l.e-MeMMtbylene  dllsocyenete
799.5000
                         54 II 8112    02/24/89  02/24/89  lusting Consent Order  • neurtulclty.
            05/17/89  54 II 21240
            06/02/09  54 II 21719
            05/10/59  54 II 12529
                                                                  effects.
                                                           Correction.
                                                           Efttons ion of consent period.
                                                                        11
                                                                              (06/10/90)
-------
HAKE
RULE Of RULE
CODE CM PI
147 Crota
W •
Mldehyde
PROPOSED
40 CfR RULE
CIIAIION OAIE
799.5000
PIOPOSCO MHAl RULE
RULE fR fR
CIIAIION C|TAIION
S4
fR 47082
flHAL RULE
PURLISH
OAli
n/09/69
EffECIIVE
OAIE
11/09/09

HOIES
letting Content On


tor tor


Crotonaldehyda


(2-Rutenol)


• CAS
t46   C. I. Oitpertt KIM 79il
799.5000
S4 fR 46102   11/21/19   11/21/69
Ha. 4170-30-1;  par fora ctrltln Chealcal ftti and
Emlromtntol offtctt tttll.

letting Content Order for C.  I. Dliperte Rlue 79:1 (OB-79i
• CAS Ro.  1616-72-2); perfora certeln Mettth end
EnwIrenMntol effecte tettt.
t49   4-Nonylptienol. trenched
799.5000    02/06/69   54 fR  6UO    SS fR S99I    02/21/90   02/21/90
tSO   Technical  Acentaentt to letl R
      utet	
                                        799
                                    SS fR nil    01/01/90   01/01/90
tSI   N-Nethylpyrrolldone
799.2900    01/26/90   SS fR  11196
t52   Nouto Vitiblo Specific locut I
      ett Reojulr
798.1195    12/21/66   SI fR $1647   SS fR  12419   04/OS/90   OS/21/90
                                        799
            12/21/66   SI fR $1647,  SS fR  12619   04/05/90   OS/21/90
                                  letting Content Order for 4-Honylphcnei. branched • CAS Ho
                                  646S2-1S-1* <• • US dooa net cenalder thlt nuotwr to
                                  rcpreient • unique chcnicel  tubettnce).  Certain cholcal
                                  fata and envlronnentol offecta tatta Mill be parforned.
                                  ChcMlcal oattly coaprlaod of para-branched C9 oUylphcnolt

                                  IPA haa •pprowad by latter certain •odlf Icatlono to tett
                                  tlandtrdt and tchadulea.   thtie oodlf (catlone cover the
                                  period froa) October 1. 1966  to September 10. 1969.  Verleu
                                  CAS nctiere covered by final rulee and tatting content
                                  ordera afpaar In tbla rule.

                                  Propoted rulo • to reojilro •anufacturare and procattort to
                                  tett for oncogenlclty, •ulagenlclty. dtvalopMntol toilclt
                                  r«productlvo toilclty, nturotoilclty. aiAchronlc toalclty,
                                  and pharaacoklmtlca. Specific CAS No. la 672-SO-4. Concer
                                  Me aa tUwtltuta for Netaylane chloride In point ttrlpper

                                  AlloMt tett tpentora to chooto either tho NVSL or the Noue
                                  6leche*lcal Specific locut latt INRSl). Alto, prooulgttet
                                  t*tt guideline for MRSL;  tpaclfloa reporting rooplrcacnt c
                                  SI •ontha for teat coaplotlonj and apoclf lea apaclBtn
                                  retention reo>ilreamta.
                                  Ciengee In NVSL reoplreawtte affect final tatt rulet fort
                                  fliwoalkcnea. Oleyleailna CPhaee  I 6 Miaao II). Cam-del
                                  Rtiene, Untubttltutod Phenylenedle«lnet. 6 Itopropenol; or
                                  propoted teet rule fori trlethylene glycol oanoMthyl,
                                  •onoethyl, 6 •anobutyl ethere.
                                                                        14
                                                                                                                      (Oo/U/90)
-------
        NAME
UllC   Of MA.E
CODE   M fW i
 40 CM.
CUM ION
PROPOSED
 •ME
 0*11
PBOPOSEO
•WE M
CIIMIOH
MNAL MAE
   ii
 CUM ION
MIUL UHE
  •MUSH
   OMI
EffECIIVE
  OMI
                                                                                                                  NOUS
ISI   lest Ing Consent Agreements a I
      •It lutes
790
 os/ir/69  34 fi 2i2«   ss H taaai   os/or/w
IS4   Off let of. Orlitklng Itotor Chwil
      cols
79S.IS7    OS/24/90   SS H II19I
                                       7V9.S07S    OS/24/90   SS H 21191
                                    06/21/90  Clialnou* roojulroamt that coruln Mnuf*ctur«r* fllo
                                             ioiuro of Intent t« tmt or oiMptlon oaplUatlora union
                                             no other o«nufoctur«r tubiUt • letter of Intent to teet.
                                             Modi He* reqjilreevnt to outalt otuo> plane of  leeet 4$ dot
                                             prior to InltUtlon of lotllnf by olUlnetlng  roojulroMnt
                                             wteie It lo epoclf lod In o pertlculor tool rule or teetlr
                                             content order,  fee oleo Notice of line!  ruloMklng on del
                                             I'eietMreeMnt (4i » 31186; 07/1 t/U} I Hot Ice of Inter!*
                                             llnel rule on olnglo-phete teet rule dewolopient end
                                             tlon*prace4jree (SO » 206S2; OS/U/BS).

                                             acquire •enufecturers end proceeeore to teet five eubetom
                                             1or ore! 14-dey repeated doeo end oral 90-dey  outekronlc
                                             aonlclty atudlee.  Aleo. proposes • MM testing guideline
                                             for 14-dey repealed daseorel toilclty otudy.   Ckealcele
                                             Includet Chloroelhene (CM Mo. 7S-00-]))  I.t-Dlcnloroethei
                                             itM Ho. 7S-14-1)) 1.1.2.2-letrecMoroetlMM (CAS Ho.
                                             /9-14-S); n-rropylbeniene (CAS Mo. tOS-6S-1)>  ond
                                             l.S.S-lrlMthylbeniem (CAS lo. toa-47-B).
                                                                      IS
                                                                            (06/SO/90)
-------
NAME PBOPOSED
MAE of BUIE «o era MILE
CODE OB PMU fl CIUHON OAlf
Ml PCIl • 741 06/07/76
04/22/82
06/08/82
12/Ot/Bl
10/11/84


07/06/87
09/04/87

761.80 08/24/88


08/21/87
09/18/87



761 09/26/88
PBOPOSEO
BUIE fl
CIIAIIW
41
47
47
48
49


S2
S2

SI


S2
S2



SI
IB
fl
fl
fl
fl


fl
ft

fl


fl
fl



fl
24802
17426
24976
SS079
diWoQ


2S618
U680

12126


11718
1S1SO



17416
HMAl BUI
fl
(1 1 AIION
44
47
47
49
SO
S2
SI
SI

SI
SS


SI

SI
SI
SI
S4
fl
fl
fl
fl
fl
fl
fl
fl

fl
fl


fl

fl
fl
fl
fl
11)42
17142
46980
28171
29170
10688
40682
24206

29114
21021


27122

11697
21641
2S049
S27I6
flNAl BUIE
PUBLISH
DAtf
OS/11/79
08/2S/82
10/21/82
07/10/84
07/17/6}
04/02/87
10/19/88
06/27/88

08/02/88
OS/22/90


07/19/88

09/01/88
06/09/88
07/01/88
12/21/89
SffECFIVE
OAIE
06/02/79
09/24/82
11/22/82
10/01/84
08/16/6S
OS/04/87
10/19/88
07/27/88


07/OS/90


09/01/88


06/09/88

02/OS/90
HOIES
Ctittln prohlblllom.
Us«i In electrical •o/ilpasnt.
Closed 1 controllod Hsst* •snufscturlng process.
InwKertcntly gonereted.
Usn In electrical trsneforasrs.
Sptll cltan-iM) policy.
Spill clsan-tM> policy; BMntasnts 1 clarifications.
Exclusions, eieoptlona A uae authorliatlons.
EMluslona. eieoptlona A uae authorliatlons; corrections.
EMlusluna. eionptlons 1 use authorliatlons; corrections.
Nsiwlaciurlng. processing, and distribution In coonercs
eaeqptlons; proposed rule, lesponse to petitions; flnsl
rule.
PCBs In electrical Iranaforaera.
PC9s In electrlcel Iranafanara; correction.
Correction.
Incorporation of teat Mtbods.
Incorporated of teat Methods; correction.



















•olltlcstlon and Nenlfestlna for KB Uaste Actlvltlss; flm
rule •fltcu 40 CM sections 761.1. 761.6S, Sufaparte J ft K
PCBs • 11/09/88

761.80 09/12/89



N01E FOB PCM HOIE fOB •!
SI

S4



fl

fl



4S288

17698



NOIE t(* Ml


SS


S4


fl


fl


21021


28419


OS/22/90


07/06/89


07/OS/90


87/06/89
MIE fOB Ml
•otlllcstlon i Nsnlfestlnj for PCI Haste Activities;
••tension of public ceaaant period.
•sapcn connent period until 10/12/89 for awnufaclurlna.
processing, distribution In coMMrce eieeptlons; proposed
sumption soMndMnt. lesponae to petitions; flnsl rule.
Correction; PCIs In electrical trsnsforMrs.






• Ihla la not ••caakilete list of federal leglater rsfsrenci
for PCIs. for purposes of compliance, you should corouli

Correction; Hot ideal Ion 8 Mn 761.65















SS



fl



69S



01/08/90



01/08/90


title 40 • Cods of fodsrel legulotlons.
Correction; Polycblorlnated llphenyla; Hot II (cation and
Manifesting for PCI Haste Activities final lule published
12/21/89 
-------
MANE PBOPOSCO PIOPOSCO MHAL MAC MUM. Mil
RULE Of MILE 40 CM MAI IULE » f8 PUBLISH EffECIIVE
CODE OR WW 0 CIIAIIM DAtf CIIAtKM CIIAIIM OAIE OAIE HOIEI
Rotlca of Aval lability PC6 Pan 761 09/IO/M 41 fl S977A SS H 11955 04/11/90 04/09/90 Inter In guidance m
w proposed on OI/IO/M. Interlai guld*
      PCM Notification ft Itanlfmtin    761
M2    crca •
      HOIE KM CfCa
*1    IrlathanolMina aalt/Irlcarbon
      yllc Kid

«4    Irtathanolaalna aalt/Sufaatltu.
       erg. acid

•S    NUcd Nono ft OlMldts of M Or
      •Mlc Acid

•6    JUUttos  •
SS ft 262M   06/27/90  06/27/90
      NOIE rot Atbtitos
762
HOIE fn
747.200
747. 19S
747.115
761






HOIE JOB
OS/11/77
U
01/21/64
06/14/64
09/20/64
09/17/60
07/12/8S


01/29/86
04/10/67

«6
42 » 24S42
•Oil fOI a2
49 » 2772
49 t» 24666
49 » 166SS
4S !• 61966
SO » 2*510


SI » 1716
52 ft 1S611

HOIE fOH «6
45 16 11116
Mil 106 U



47 f 6 2IMO
SI fl 1S722
52 16 5616
SI 16 1021
54 M 29460
52 16 41626
54 16 17511
HOIE roo «6
01/17/76




05/27/62
04/2S/64
02/25/67
02/15/66
07/12/69
10/20/67
09/11/69

11/15/76




06/26/62
06/09/66
01/27/67
02/15/66

12/14/87


                                       761
                                                                          54 » 46697  11/06/69   11/06/69
«•• pUbllthod on 09/10/80.   IMo rovltod poli|cy Mill prov
for ponililot In wtalnlttrotlvo civil octlon^.  r«wltlo>
•ro ditoralnod Ino olooooi  |l| dstoralnotlon of o "grovlt
buod ponolty" (C») ond (2) odjustamto la lha COP.
Correction: final rula.  Canada lachnlcal arrora In
54 H 52716 C12/21/69I.  Corractlom covtr 40 CM 761.1;
761.65;  761.160; ft 761.215.

Prohibition of wa.
• Ihla la nal a ceaplata Hat af fodaral Riglatar rafaran
  for CfCa.  for purpoaaa of cc«pllanca. you ahould comu
  lltla 40 • Coda of fadaral laautatlona.

MtalMrklnj fluids; liMdlataly affactlva.
                                 NatalMarklng fluids; lawdlattly affoctlva.
                                 MtatMorklnj fluids; laMdlataly affoetlva.
                                 Aibtstoa In schools.
                                 Merkar prolootlon; laMdlataly affactlva.
                                 llorkar protMtlon; Incorporation of nan OMA raguUtlons.
                                 lachnlcal aiandaant.
                                 Om/phasa-doMi.
                                 Aibastoa-containlno aatarlala In schools.
                                 Correction; ban/phasa-dom.
                                 • Ihla la not a coaplata Hal of fadsral 6aglalar rafaran
                                   for Asbastoa.  far purpoaaa of cospllanca. you ahould
                                   consult lltla 40 • Coda «f fadiral ••gulatlona.
                                 technical aamtoant; Asbaatoai Nanufactura. laporutlen,
                                 Pracasslno, and Distribution In CoMwrca Prohibitions fir
                                 •ula punllshad as 54 f6 29460 f07/12/89).
                                                                      17
                                         (06/10/90)
-------
        DAME
RULE   Of RULE
to*   a»PHH»
                                       40 Cf 1
PROPOSED
 RULE
 OMi
PROPOSED
RULE fR
CIIMIOII
flNAL RULE
   IR
 CIIAIIOII
 ftHAL RULE
   PURL ISM
	P»'f
                                                                                                 EMECIIVE
                                                                                                   0«H
      Atbettot; Pt*ilcotlon of Ident
      Correction; Aibe»lo«; Public*!
•7    Tttrothtorodibtnto-p-dtwiin
                                                            HCWE
                                                                                       02/11/90
                         ii H 20S22   Oi/U/90  05/09/90
                                             tuwHe* of Information wbiltted by Mnufocturer* end
                                             iprocenor* of certoln etbeetot producte In eccordenc* wltti
                                             the Atb**to« InfofMtlon Act ol 19U.
                                             Correction notice for Aibetto*; PUtllcetlon of Identlfylne
                                             InforMtlon.  Corrects tMHMrle* of InforMtion cubnltted
                                             •enufaeturer* and processor of certain e«bctta» products.
                                      766
 01/11/M  40 It MS17   *4 H  UftTf   05/IV/W  M/12/00  tCOO;  ditpot»l ol MMte canulnlr* ICOO;
                                                          eMecilva.
                         49 M  *499f   II/14/M  12/14/14  Chonge of oitalnUtrttlvo outhorlty; frontier to EPA Offlcf
                                                          of Solid Vuto.
      H*N«v*lent ChraaiuMCooiforl  Co
      ol.  loner*
                                      K9.68
 01/29/M  SI II 10206   SS fl  221     OI/OJ/W  02/20/90
                                             Prohibition of Meaovolent Cbrooilui Cltealcoi*  In Coalort
                                             Cooling tower*.  Prohibition of distribution  In comerce i
                                             effective on 02/20/90.  Prohibition of coMwrcUl u^t I*
                                             effective on OS/Ia/90.  Ltbellng, recordkeeplng, end
                                             reporting reqMlreMnt»  e»l*t.
                                                                                                                   (06/10/90)
-------
           CHEMICALS ON REPORTING RULES DATABASE (CORR)

                     October 31, 1991 UPDATE

               U.S.  Environmental Protection Agency
            Office of Pesticides- and Toxic Substances
                    Office of Toxic  Substances

                         Compiled by the
              Existing Chemical Assessment Division
                Chemical Screening Branch  (TS-778)


     The  Chemicals  on Reporting  Rules  Database   (CORR)  report
contains  information on chemicals that have been the  subject of
proposed  or  final   regulations  issued by  the  Office of  Toxic
Substances in the Federal Register (FR).

     This CORR document contains two tables and a rule code list.
The  first table  contains  the Chemical  Abstract   Service  (CAS)
Registry Numbers that are referenced in the  final list.  Following
the CAS number table, there is table of  Premanufacture Notice (PMN)
substances.  Both of these tables are cross-referenced to the rule
code list, which  cites Federal Register publication information.
The rule code section provides: FR citations, the Code of Federal
Regulations (CFR) citation (when available),  dates relevant to the
FR citations,  and other information  contained  in the FR citatipn
relevant to the action.

     All  of  the  information  that was  published in the  4/30/91
update of  CORR is included in this report. This document  is an
amendment to the 06/30/90  CORR Database Report and  it covers the
rulemaking period from July 1, 1990 to October 31, 1991. Therefore,
to complete your copy  of  CORR,  only the 6/30/90 original edition
and the 10/31/91 amendment (this document) are required.


IMPORTANT NOTICE:

     This  document   is  intended to  be an  information resource.
Since it may contain errors, omissions,  etc. , this document SHOULD
NOT be used  in lien .of FR documents or the CFR for purposes of
compliance.  Please report any  errors or omissions to Tess Bateman
at (202) 260-3416.

     Copies of the 6/30/90 and 10/31/91 CORR Database Reports are
available  from the  TSCA  Hotline at  (202)  554-1404, or  you may
request copies through the following address:

     U.S. Environmental Protection Agency
     OPTS/OTS/Environmental Assistance Division
     Mail Code: TS-799
     401 M Street. SW
     Washington, D.C. 20460

 .OTE: You can also fax your request for the CORR Database Reports
or other TSCA publications to  (202) 554-5603.
-------
      Rule codes are a letter and number combination. Rule codes
 beginning with the following letters  are used throughout this
 document, and correspond to the specified action:

      a »   TSCA section 8(a) chemical  specific rules  (proposed and
           final rules)

      c =   TSCA section 8(c) requests  for records and reports
           regarding significant adverse reactions

      d =   TSCA section 8(d) rules requiring the submission of
           unpublished health and safety studies (proposed and
           final rules)

      e a   TSCA section 12(b)  export notification rules  (proposed
           and final rules)

      f =   TSCA section 4(f) required  actions

      m <*   TSCA section 8(a) comprehensive Assessment Information
           Rules (CAIR)  (proposed and  final rules)

      p «   TSCA section 8(a) Preliminary Assessment Information
           Rules (PAIR)  (proposed and  final rules)

      r «   Substances subject to reporting period terminations
           under the. TSCA section. 8(d) rule

      s -   TSCA section 5(a) Significant New Use Rule

 srllO -   List of  hazardous substances under S104(i) of the
           Comprehensive Environmental Response, compensation, and
           Liability Act.. (CERCLA or Super fund) as amended by SARA
           5110

 sr313 =   List of  toxic chemicals under 5313 of the Emergency
           Planning and Community Right-to-Know Act (EPCRA or SARA
           Title III)

      t =   TSCA section*4 test rules and consent orders  (proposed
           and final rules)

     x -   TSCA section 6 risk management rules  (proposed and
           final rules)
     For more information on the Agency  for Toxic  Substances  and
Disease Registry  listing, ranking and toxicological profiles
contact Dave Brooks at  (202)  260-1501. Send your written  request
to U.S. EPA, 401  M. Street,  SW,  TS-796,  Attn: Dave Brooks,
Washington, DC 20460.
-------
          CHEMICALS ON REPORTING RULES (COIR) DATABASE*



CHEMICAL ABSTRACT SERVICE (CAS) REGIS!RY NUMBERS I CHEMICAL MANES
CAS NUNUR
S7-10-3
60-29-7
67-63-0
67-64-1
71-36-3
71-55-4
74-97-5
75-02-5
75-15-0
75-63-8
75-69-4
75-71-8
75-88-7
76-14-2
76-15-3
78-40-0
78-42-2
78-51-3
78-83-1
79-10-7
79-31-2
CHEMICAL NAME
Henadecanolc Kid
Dfethyl ether
Isopropanol (ska 2-Propenol)
Aettom
1-Butanol (aka n-Butyl •leehol)
1,1.1-Trlchloreathane (ska Methyl chloroform)
BroMchlorosethane
Vinyl fluorlds
Cartoon dlsulf Ida
Brcaatrif luoi asethana (Halan-1301)
TrlehlorofluoreMthana (Crc-11)
OlcMoredlfluoroBethane (CFC-12)
Ethana, 2-chloro-1.1,1-trifluoro- (HCFC-133a)
Ofchlarototrsfluaroathena (CK-114)
(avw)Chlerapantiftuoroathana (CFC-115)
Trlathyl phosphate (aka Phosphoric acid, triathyl aatar)

•thvUttxvl) Mtcr)

irtstc-DutBxyeuiyij pnospnata caiu ctnanoi, c-Buiaxy*,
phoaehata (3:1))
Isobutyl alcahal (aka 1-Propanel, 2-Mthyl-)
Acrylic Acid
2-Mathylprepanalc acid
RULE CODE
t56
t57
t58, t55 - aaa alao COM
lUtinot 6/30/90 (t40.
P1S. d19. a>313. t52)
t57 • aaa alae CORR
Uatlnga 6/30/90 (ar110,
ar313)
t57 • aaa alaa COM
listings 6/30/90 <«r315>
t55 - aaa alaa CORR
listing* 6/30/90 (srIIO.
PI. d1. tl. sr313)
P24, t56 - saa also CORR
listings 6/30/90 (srllO,
dM)
t58
tS6 • saa alae CORR
Uatlnga 6/30/90 (srIIO.
sr313)
sr313 - saa alao CORR
listings 6/30/90 (sr313)
arSIS • aaa alao COM
I latins* 6/30/90 (a4110.
ar313)
sr313 - saa also CORR
listings 6/30/90 (srIIO,
ar313)
aSS, d2B - aaa alao CORR
listings 6730/90 (s55.
d28)
sr313 - saa alao CORR
listings 6/30/90 (ar313)
sr313 • saa also CORR
listings 6/30/90 (sr313)
dB9. P24 - saa also CORR
listings 6/30/90 (C2)
079, P24 • aaa alaa CORR
listings 6/30/90 «2>
d29. P24 - saa alao CORR
listings 6730/90 (C2)
t57 - saa also CORK
listings 6/30/90 (d16)
t62
t56
                                                                             (10/31/91)
-------
           CHEMICALS OH KPOSTIM6 RULES  (COM) DATABASE



CHEMICAL ABSTIACT SEIVICE (CAS) ttSISTIT MMEM t CHEMICAL HAKES
CAS HUMKI
79-94-7
87-10-5
87-83-2
87-84-3
91-97-4
95-51-2
95-5*-$
95-63-6
95-80-7
96-13-9
96-29-7
96-37-7
98-82-8
100-21-0
100-28-7
101-68-8
102-36-3
103-71-9
104-12-1
104-49-4
104-76-7
106-50-3
107-13-1
107-66-4
CHEMICAL MANE
TAOa^A^BM^^fl^fcl OMalk^MOJkl mA * "
3.4',3-THbraMMlicyUnllldt
2.3.4.5 .6-PontabroBOtoluana
1,2.3.4 J-P«ntabroBO-6-chlorocyclalMuno
4,4'-OHaacy*nato-3,3'-dla»ttiylblplMnot
2-ChleroantMna
o-PhonylanadiaBlno (ako 1.2-Saraanadla*
t58
156, tr313 - aao alao COM
llatlnga 6/30/90 (srSIS)
P24, d29
P24 - aaa alao COM
Matins* 6730/90 (C2. d28,
arSIS)
P24. d29
P24, dZ9 • aao alao COM
1 latinos 6730/90 (M)
P24. d29
P24 • aao alao COM
Matins* 6730/90 (C2. d20>
Matins* 6/30/90 Ct22,
d20)
tSB. tSS • aaa alaa COM
Matins* 6730/90 (t36, PI,
dl. arSIS. t52)
tS6 - aoo alao COM
Matlnao 6/30/90 (arllO.
ar313>
P24. d29
                                                                             (10/31/91)
-------
           CHEMICALS ON REPORTING RULES  (COM) DATABASE



CHEMICAL ABSTkACT SERVICE (CAS) REGISTRY MUNURS I CHEMICAL NAMES
CAS NUMBER
108-10-1
108-39-4
108-45-2
108-67-8
106-M-?
109-90-0
109-99-9
110-54-3
110-78-1
110-80-5
111-11-5
111-36-4
111-40-0
111-63-19-5
111-91-1
112-50-3
112-96-9
118-79-6
120-80-9
120-82-1
123-30-8
123-61-5
123-86-4
124-73-2
126-71-6
CHEMICAL NAME
Methyl iaobutyl ketona (aka 2-Pehtanana, 4-a*thyl->
Neta-creaola (aka Phenel. 3-Mthyl-)
•-PhenylenadtaBlna (aka M-DiaBinobensana; «-POA;
1.3-banzene diMina)
Beraene. 1,3,S-trle»thyl-
Nonachlarabaniena (aka 1.2.3-Trlchlorabaniane)



i atranyvi oiuran
"••—
n-Propyl Itocvanato
2-Cthexyothanol
Methyl eater octanetc acid
n-Butyl ItoeymM

D i •tnyicfMiri Hii iw
OeCflB^QHOQ i fnUfjf I OX 1 flV
8ls(2-Ghlorotthaw)Mth«w


Octcdtcyl itocywt9
Z • •• • O* * k* f DCQiMplMnO i
e-HydracyphOTDl faki Cattehal)
1 ,2,4-Trlehlorabtnsm
D"Mn IIOBIMnOl
1.3-eMMeymtetanitrw
n-Butyl M«tatt
DlbroHtMtrafluBrotthm (Hal en- 2402)
TrlfMbutyl phosptwt* («ka Phosaliorle acid, trla (2-

RULE CODE
tS7 - ••• alao COM
liatlnga 6/30/90 (arllO.
PI. d1. ip313)
t55 - aaa alto COM
Uatfnga 6/30/90 (P1. d1.
ar313)
t58. tSS - aaa alto COM
liatirwa 6/30/90 (t36. PI.
dS. tS2)
r3 - aaa alaa COM llatii«
6/30/30 (dS. p7. t54)
t53 - ••• «Uo CORt
liatinga 6/30/90 (aMIO.
PI. d1. tlO. arSIS. tSO)
d29. P24
t57 - aaa alao COM
liatinga 6/30/90 (erllO)
t35 - aaa alto COM
Hating* 6/30/90 (arllO,
tSO. t52)
P24. d29
tS7 - aaa alaa COM
Hatlnga 6/30/90 (ar313)
tS6
P24. d29
t58
x7
tSB
tsa
d29. P24
*7
tS6 • aaa alae-COM
liatinoa 6/30/90 (ar313)
tSS - aaa alao CORK
liatlnoa 6/30/90 (arllO,
PI, dl. t8. tlO. tr313)
tS6
P24 - aaa alaa COM
liatinga 6/30/90 (C2. d20)
t57
ar313 - aaa alao COM
liatinga 6/30/90 CtrSIS)
d29. P24 • aaa alao COM
liatinga 6/30/90 (ar313)
                                                                             (10/31/5
-------
          CKBUCALS OH MPOniM MAJS (CORD DATABASE



fMENICAL ASSTUCT SOVICt (CM} U6ISTIY MMUM * CHEMICAL NAMES
my HUNK!
126-73-8
141-78-6
U1-79-7
142-84-7
143-33-9
149-30-4
149-57-5
298-07-7
306-63-2
329-01-1
333-59-3
354-33-6
421-01-2
526-73-8
556-67-2
585-07-9

593-60-2
611-14-3
614-68-6
615-58-7
620-14-4
622-58-2
622-96-8
624-83-9
OKNICAL MANE
Trfbutyt phasahsto (ska PhoaphsHc acid, tritautyl aatar)
Ethyl acatata
Naltyl oxidt
1-PropanaBina, N-propyl
Soditai cvanids
2-Norcaptobansothlazolo (ate 2(3N-)b*nsotris*olo atMons)
2-ethylhaxanolc acid
Dl C2*otliyllMxyD oHonlMtt
Ithana. 2,2-dfchlore-1.1.1-tHfluor«- (NCFC 123)
(alpha; aloha; aloha-Trifluoru-o-tolyl) Itoeyanat*
•POBOCnlOPOBlTlUOI^flHiTCfltW •
Cthana. pamaf luore- (MK 125)
IraaodilerodlfluoraMthana (Halan-1211)
••ntana, 1,2,3-triaattiyt
OetaBathylcyetotatraal louna
t-lutyt aathaerylata <2-*rapanoic acld-2-awthyt-l.l-
aiBwinyiauiyi aatari
Vlrylbraridt (ate Ethana. taraao-)
•1^M*^MHM 1 B««aW«i «9^BB^A*W«I «
•wWf i ••jui|ri ••"•miyt *
i*l8OCV8TOCO*2HHttiylMfWW
2.4-Olbrwoatianal
BaMBjaia^ia^ f • Aft^a^rf • V^a^HmA^H^I •
•raWf i *tnnyi **TBwiny i •

MncvWf i*ttiiyi*4*flB9tnyi*
88M*4^k«l 1 aua^ia^a^B^*^
PWHyl IMCynTw
KAE GOBI
158. W4. t55. d29 - Mt
also COM tUtlrvt 6/30/90
(C2. t37. PU. dIB)
t57
t6 - aaa also COU
lUtinga 6/30/90 (P8. dl,
t6)
r3 - aaa also COM I latino
6/30/90 (d16)
dZ9. P24
t55 - M* alia con
lUtings 6730^0 (C25. P9.
dIO. ISO)
tS5 - aaa alto COU
liatlno* 6/30/90 
rS • aaa also COU listing
6/30/90 (d3)
d29. P24
rS • aaa alaa COU Hating
6/30/90 (d3)
P24, d29 • saa alaa COU
listings 6/30/90 (ar313)
                                                                        (10/31/91)
-------
          CHEMICALS (W REPORTING RULES (CORR) DATABASE



CHEMICAL ABSTRACT SERVICE (CAS) REGISTRY  NUMBERS I CHEMICAL  NAMES
CAS NUMBER
628-63-7
811-97-2
812-00-0
1070-03-7
1163-19-5
U76-Z3-9
1498-51-7
1511-62-2
1623-15-0
1623-24-1
1649-08-7
1717-00-6
2421-27-4
2422-91-9
2493-02-9
2837-89-0
2873-89-0
2909-38-8
2949-22-6
2958-09-0
3173-93-3
3194-99-6
3618-72-2
3900-04-7
3991-73-9
4033-89-6
4098-71-9
4191-91-3
4162-49-2
9124-30-1
CHEMICAL NAME
n-Anrl acstats
Ethm, 1,1.1.2-tatraflusro (HFC-124a)
NsnsBSthyl phsiphata
Nm(2-sthylhsxyt) phosphsta 70
Dscabrosadiphanyl athar (DBOPE)
3- 1 »ocyanata-1 -proptna
Ethyl dlchlsrophesphsta
Nathan*, braaadlfluore-
Manofautvl phosphats
Nm(iaapropyl) phasphata
Ethm, 1.2-dlchlaro-1,1-diflusra- (HCFC-132b)
Ethm. 1,1-dichlaro-l-fluoro (HCFC-Ulb)
2-Praomic Kid. 2-hydraiybutyl ttttr
l.l'.l'-NBthvtldymtrfs (4-lMcymte bwam)
1 -8raw4- lseeyvMtaBifa«w
Ethm. 2-ehlore-1.1.1.2-t*trafluor«-
Ethirw, 2-ehloro-1.1.1.2-t*trafluero- (HCFC-124)
l-Chlere-3-ftocyvwtetarutnt
Ethyl 1 •ocywiiito Acctflttt
Monooct^dMyl phosplMtv
cyciofMMyt fsocyw»9
HtutoreMyelododwm (HMD)
C.I. DfwTM Blw 79:1
MonohcKyt phosvhfttv
Monaoetyl phaiehit*
TrU(itoeyvMtelMxyl) biurct
iHBtaram diisoeymtt (ate Cyclohimw, 3-iMcymto-1-
(iMeymtOMthyl) 1.3.3-tr
Tr1t(4-lMcywatOBhanifl) thiephesphctt
EthoxyUtcd tctrabrflaebisphmol A
I.V-MthylafHbi* (4-lsocymteeycleheunt)
RULE COM
tS7
d28 • ••* alto COM
listings 6/30/90 (d28)
dZ9. P24
P24. 
•61
P24. d29
d29. P24
•71
d28 - M* alia CORR
listings 6/30/90 (d28)
-------
          CHEMICALS OH REPOTIM OJLES (COM) OATAIASE



CKBIICAL AM1RACT SERVICE (CM) REOI8TRY NUMBERS ft CHEMICAL HAWS
m NUMBER
5384-21-4
5873-54- 1
7057-92-3
7352-46-9
7664-39-3
7782-41-4
10031-79-1
1ZS10-42-S
12645-31-7
12751-23-4
14302-13-7
15646-96-5
16086-31-4
16938-22-0
25327-89-3
25550-14-5
25551-13-7
25854-16-4
26447-40-5
26603-40-7
26747-90-0
27193-86-8
27215-10-7
28178-42-9
28556-81-2
29091-20-t
29305-12-2
30554-72-4
30554-73-3
CRBI1CAL NAME
•Hanoi .4.4'-a*thylanabia(2.6-dlOTthyl)


Oidodtcyl oiMsohata
2-(2-hit9xycthaxy)athanol phosphate (3i1)
Hydrogsn Fluoride
Fluorine
DiohenylMthylent dllsocyanate
EHonit* fiber
2-Ethylhexyl phosphate
OodMvl phosthito
C.I. Plow* 6rtm 36
1 .6-01 lsocvMto-2.4.4-tHB»thyllwuM
Oxlrane. 2.2>-(1.6-(MundlylbU(oxy-wthylant))b1s-
1 .6-01 isocymto-2.2,4-trlMthyllMum
TotrabroBotolsphsnol Af bis(allyl) •ttetr
Mrom, •thylMtliyl-
8smWf criBMwiyl*
Bfs(lsocymtoMthyl) bsnmw
1V 1 >*Ne;tiiyls9iiDift*C tsflcyvMtoDMUfM)
. ii.
1,S.5-Trf*(S-iMcymtaH«iylBlMnyl> 1,3,5>trfM-tr1om
Tolusm dllsoeyiMt* dl«r.
Dodscyletisnol
Oil SOQCtyl PhOBPHBtS
2,6-01 IsapreprlplMnyl Isocysrat* l»km l«usm. 2-
1.3-bU (1-wthyl*thyl)->
Bcnnm, 2-lMeyvwte-1f3-diMthyl- (tka 2-Isoeyirato-
1.3-dlsMHyttasfmm)
MntsiMBln*. 3-chlore-2,6-d1nN-d4propyl-4-
(trifluoroBittiyl)
1.3.3-Tr1uiiw-2.4.6-tris*lM, hydrebronid*
TstratareMBdlchlorecvelohCMnt
TriBCCHBtricnlorocyclciMxw
RULE CON
s63
m • SOT •i*e COM
listirvs 6/30/90 (C2. dZO)
d29. P24
d29. P24 - SM also COM
(latinos 6/30/90 (C2>
srllO
srllO
d29. P24
s69
P24. d29
d29. P24
sr313
P24
sTI
PZ4 • SOT also COM
Ustlnga 6730/90 CC2. d20)
x7. d29. P24 • SOT also
COM llstinos 6/30/90
(tSD
rS • SOT also OOtt listing
6/30/90 (Dl. d3>
rS - saa also con listing
6/30/90 (dS. D7)
P24. d29
P24 • sw also Con
listings 6/30/90 (C2. d20)
•M. d29
d29. P24
t56
d29. P24
d29. P24
P24. d29 \
S67
s65
•24. d29
079, P24
                                                                           (10/31/1
-------
          CHEMICALS OH REPORTING RULES (COO)  DATABASE



CHEMICAL ABSTRACT SERVICE  (CAS) tEGISTIT MUMKIS & CHEMICAL NAMES
CAS MUMKR
'30674-80-7
32534-81-9
32536-52-0
34893-92-0
36483-57-5
37853-59-1
4126-45-2
52277-33-5
S2«9S-7t-3
54140-64-6
54849-38-*
55205-38-7
60857-97-8
64630-63-3
64742-95-6
65992-66-7
66733-21-9
68239-06-5
68955-41-9
69882-11-7
70693-06-0
73597-26-9
79637-74-4
82428-30-6
84852-15-3
85095-61-0
87320-05-6
88497-56-7
90884-29-0
CHEMICAL MANE
2-laocyanotoothvl oathocrylato*
PontabroBodlBhonyl othor (PBOE)
OctobroModlphonyl other (OBOPE)
3.5-Dlchloroehonyl Uocyanata
Trlbrooanoopontyl alcohol
1.2-BU(tHbroMOBhinoKy)-«thana
Totrafarooadlaphanol-A-talMthaxyloto
Polyfoxyl ,4-butanadlyl ).o-(1-oxo-2-Broponyl )-N- (1-eu-2-
pr oponyl )o«y|

FOiyioxy-ifZ-oinanooiyDiO-nyiiro-j-iaBironyi'Ovtnoxyi j*(
othor Mlth 2-othyl-2-(hya>axyoothyl)-1,3-prQpcnod1ol
(3:1)
Pelyn«)tno(thlo)JtrU trlitooetyl
ostor
TttrabroMbltBlMml A diaerylot*
Nothyl oxlMnt
2-Praponoie acid. 7-eMbfeyelot4.1.0]h«pt-3-yl««thyl
••tor
Solvent nophtho (potroloui) light iroMtfe
•,«,•'. ••-totrakio(o»ironylMthyl)-1,3-cyclohoMno
diovthMtno
Erionito flbor
2-Hoptyl-3.4-bJa(9-ioocyanotonoryl)-1-pontylcyelohoxono
AikoWliMc C« !•_••• Dt^QiiD dllOi^O
Zc*»"COI* Z«O|"Di DI*fliMBlliVtOl • nOMOPOiyilVF
C9 ttroBHiitiC nyrtrocftrvon frMtlon


2-Proponoie Kid. oetahydro-4.7-Mthono-1H-1ndonyl otttr
2-Proponoic ocid. 2-OBthyl-.7-oHbM>>>-(Hthylonod<-4,1-phonylano)bU
(2.2-dlMthyl-
2-Prapcnoic acid. Q-t1.1-diHthyl-2t(1-ojio-2-proponyl)
o«y*thyl-5-othyl-1,3-dloun-Syl] o»thyl ootor
8ofttona« othanyl-0 hoajopoli^arc broBinatod
Phonal,4,4''(oxybia(2.1-othanodiylthio)bU
RULE CODE
d29. P24
t59. >7
t59. «7
P24. d29
P24. 029
x7. tS9
t58
061
an
oTI
r3 • aaa alao CO)
6V30/90 (r2, p7.
IR liatina
02)
d29. P24 • ooo olM CORR
liotlnga 6730/90 (t31)
861
•66
r3
867
a«9
P24. 429
d29. P24
079. P24
tss
029. P24
871
•66
tsa
866
867
P24. 029
865
                                                                            (10/31/91)
-------
                            CHEMICALS ON IEPMTIIM WUS (COM) OATAIASC


                  CHEMICAL AISTMCT SOVICE (CM) U6ISTIT  HUNKM i CONICAL
CM
               CHEMICAL HANI
93589-69-6
96478-09-0
2-Frepmlc acid. 2-mthyl-.2-(-3-(2H-b«tiotH«iol-2-yt)-
                «thyt ottr
                              •63

                              •71
96915-49-0
                                  id
                           tVT Hltn
                          ). di-2-
                              •67
96915-50-3
               furanytl
                       f 2*
                              •67
96915-52-5
                                    - ftM^B^^Mt^^ftefeuii 14 •_,
                                     ttyBjrOinEi**"Fii * i • j i
                                                2.2«-
                                                lol
                              •67
104503-68-6
3.6.9.12.15.18.21-MptMKaMtratrf
            le acid, wdfut
•71
105658-30-8
Ettaral. 2-Mlno-.
        1m (1:1)
Mith D-hydranr-N-nltroM
•67
106158-22-9
Poly
-------
    CHEMICALS ON-REPORTING RULES (COM)  DATABASE



PRENANUFACTURE NOTICE (PHM) NUWERS C CHEMICAL  NAMES
PMM NUMBER
BS-2S7
83-570
83-603
83-769
83-817
83-818
83-906
83-908
83-909
83-910
83-1023
83-1089
83-1157
83-1162
83-1163
83-1222
83-1227
84-7
84-27
84-176
84-180
84-181
84-182
84-183
OSBIICAL NAME
Htlogontttd tlkyt pyrldint (tka fttatituttd Mthyl
pvridint)
8-Acttylo-3-dodseyl-7,7,9,9-tttrsitthyl-1.3,8-triusp1ro
[4.51 dtctnt-2.4-dlont
Substituted nitrllt (gtntric)
Subttitutsd broBothlophtnt (gtmrie)
KOInltnophtnyDtzol- B,4-dlaBino-5-s»thaKybtnitntl
dtrlvttiwts (gtntrle)

[(DinttropntnBi)szoi-iz,*-oits)ino-9*OKnojcyDtnitntj
dtrivttivtt (gtntric)
BroBlmttd tryltlkyl tthtr (gontrie)
Ethyltttd •inephtntl (gtntrie)
MinapiMnol (otntrle)
Atrino tthtr (gtntrie} (tkt tnUIno tthtr)
Phssphint dislkylphtnyl (gtntrie)
Hslogtntttd-N-(2-proptnyl)-N-(substituttd pntnyl)
tettMldt (gtntrie)
SiAttltuttd tulrint (gtntrie)
Htlegtmttd »lkyl pyrldint
Htltfltntttd pyrldint
StAttltuttd tlkyl talldt (gtntrie)
Ptrhtle tlkray tthtr (gtntrie)
N,N.M'.N*-tttrtklt(oxirtnylMthyl)-1,3-cyetehtxtnt
dlMthtnHlnt
Poly etrbexylttt tsttr (tkt Alkyl glycol tthtr tcrylie
teld dwlvttlvt)
Alknttrlol dlatthterylttt, utetituttd (gtntrie)
Pelyalkyltm glycol •rmnttthtcrylttt, «*ttituttd
Polytlkyl tlktntditl •aneterylttt, wtetituttd
Alktnttriol pelytlkyltnt glyeol tsttr terylttt
tttetituttd
Pelytlkyl glyeol •anowthterylttt, Mtetituttd
RULE CODE
•M - ttt tlto CORR
littinat 6/30/90 (s17)
•21 • ttt tlto COM
listings 6/30/90 (s21)
•63
•71, s67 - stt tito can
Mttings 6/30/90 (t26)
•71, (67 - Mt tlto CORI
littingt 6/30/90 (s29)
•71, s67 - ttt tlto CORR
listings 6/30/90 (tSO)
•71, s67 - stt tlto COM
littingt 6/30/90 (t2S)
•71, s67 • stt tlso COU
listings 6/30/90 (s25)
•71, s67 - stt tlso CORR
listings 6/30/90 (s2S)
•71, s67 - stt tlso COU
listings 6/30/90 (•»>
•71, s67 - stt tlso COU
listings 6/30/90 (s27)
•71, s67 - stt ttso con
listings 6/30/90 (s37)
•66
•64
•64
•66
•66
•71, so7 - stt tlso COU
listings 6730/90 (s41)
•61 - Stt slso COM
listings 6730/90 (s32)
•71, s67 - stt also COU
listings 6/30/90 (s33)
•71, s67 - Mt tlso COU
listings 6/30/90 (s34)
•71, s67 • stt tlso COU
listings 6/30/90 (s34)
•67 • sot tlto COU
listings 6/30/90 (s34)
•71, s67 • sot slso COU
listings 6730/90 (s34)
                                                                      (10/31/91)
-------
    CHEMICALS ON REPORTING RULES (COW) DATABASE



PtEMANUFACTURE NOTICE (PNM) NUMBERS t CHEMICAL NAMES
MM NUMBER
84-184
84-274
84-341
84-342
84-341
84-344
84-358
84-393
•£.449

84-491
84-492
84-527
84-537
84-713
84-814
84-860
84-938
84-951
84-968
84-1042
84-1167
84-1219
85-36
85-118
85-216
85-236
85-296
85-298
85-301
85-415
CHEMICAL KANE
Polyalkyl •Ikanadlal agraaathacVylata. atciatltutad
•alytaxy-M-Butanandiyl). a-(1-««»-2-pr«panyl)-a-C{1-
axo-2-prapanyl)oxy)
Z-Oxapanana, hoaapalyaar, aatar uith 3*hydraxy2.2-
diaattivlprooaneic acid (2:1). dl-2-Dropaneata
2-OMpanana, hoBBpolyaar, 2-prapanoata, (tvtraftydre-2-
furanyl) aathyl aatar.
2-Oxaaanana, haaeaolyMr. 2-prapmata. mar Hlth 2.2'-
Io«vbU<««ttivt«n«Mb<«(»-hvdrMMthvt)-1.3-nroc^iidi)
avathyll-5-«thyl-1.3-dlaun-5-yt] Mttiyl Mttr
Unuturat^ oroanlc c«pawvl (gtntrlc)
2-Chiere-N-Mthvl-N-ntet1tut«d acttMidt (otntrie)


fttetftuttd •llDtatfe acid halld* (imrle)
Sitetltuttd hvdroxylMlm (ganarle)
UnHturatcd «ino alkvl wtir nit (ocntrle)
UMMuratad Mine «t«r Mlt (omrie)
AlkamtMtd •Hum wlyol. oelywrylat* nttr (gwwrfe)
PolyntatituMd oolvol (omrle)
DlnAatitiiMd nltrotantiM (OMwrie)
Pelywr of hydrc«y«thyl wrylat* «nd polyiMcymta
(OMMTfC)
Sitetitutcd winobcntoic acid Mtar (atntric)
Alkyt Mtar (ganarie)
fak«Aa^^^iMiC*fcldftC^ •^•ttfBl fli^Mt>4ka«t A ^«aaia^a« aBMBl t«l •>•• «B^*8k^^^B^^4 ^^
KalrHllHlBBl MllOlE MCmf •BVMlfl'f COBflpDOT •IUl •EfQIaWWElHll Iw
(1:1)
Sitetltutad bla(hydraxyalluna) pelywr with
apldilorohydrln aerylata (ganarie) (aka apoiy raain
(oanarle))
Sitetltutad avrldfna (ganarlc)
SitetlluMd ovrldlna (ganarlel
Polyurathana (ajanarie)
Najloajanajtad pyFldlfia Cajanarlc)
SiAatttutad pvrldlna {ganarlc)
Aanno acrylata •onoavr Cflanaricl
Avfno acrytata aflnaaar Coanarfc)
Urathane aerylata
Nonoacrylata (ganarle)
RULE CODE
a71, a67 - aaa alaa COM
Katinaa 6/30/90 (a34>
a61 - aaa alae COM
listing* 6/30/90 fa39)
871, a67 - aaa alao COM
Ifatinn 6730/90 (a38)
871, a67 • aaa alaa COM
llatlnn 6/30/90 (aSB)
871, a67 • aaa alaa COM
Ifatinaa 6/30/90 
-------
    CHEMICALS OH REPORTING RULES (CORK) DATABASE



PRENANUFACTURE NOTICE (PNN) NUNECIS * CHEMICAL NAMES
PNN MJMKR
85-527
85-535
85-536
85-544
85-545
85-546
85-547
85-708
85-706
85-718
85-1013
85-1034
85-1169
85-1170
85-1180
85-1184
85-1370
86-66
86-83
86-136
86-164
86-334
86-335
86-346
86-387
86-501
86-503
86-542
86-554
CHEMICAL NAME
Vinyl epexy eater (generic)
Naleganeted pyridlne (generic)
Hategenated pyridlne (generic)
2-Prepenelc teid. 2-aetJiyl,7.7.9-triaathyl-4.13-dle*e-
3.14-dlexe-S.12-diasahexadecane. 1.16-dlvl eater
2-Propenoic Kid. 3-(dla»thylaBino)-2,2-dla»tnylproeyl
astir
2-Preptnole Mid, 2-B»thyl-.3,3.S-trlB»thyl eyelehnyl
•kctr
2-Prepenelc aetd.S.S.S-triMthylcyclahexyl eater
2-Propsnol, 1-«1na-. reaction product* tiitli e»la*tne,
polywr with 5-isacymte-1-«MeymtOBtthyl)-1,3,3-
tr
-------
    CHEMICALS OH RCPWTIHG MJLES (COM) DATABASE



PIBMMJFACTUU mriCE (PHD NUMBERS ft CHEMICAL MANES
PMN NUMBER
86-588
86-630

86*632
86-838
86-1088
86-1098
34-243

86-U92
86-1634
86-1692
86-1719
•jL-«7ydi

87-90
87-147
87-723
87-739
87-794
87-930
87-931
87-1192
87-1337
87-1760
88-217
88-270
88-436
88-522
88-701

CHEMICAL NAME
Poly (OKy-l.2-othanadlyl) a (2-Mthyl-1-aM-2-propanyl)-
BM^dhB^MMM^K •* •*! ft*»«l AOkk^^iM
••nyoran^ • C«A_«A •iKy* •IMPS
Mtthacrylfc nt«r (gtntrle)

oxi rant
Nalogonotod Mtetttutod pyridln* (gorwrle)
Substltutod hydroxyalkyl alkonoato, (I[[I(1-on-2>
proptnyl)oxy)olkoxy]cartoenyHino]BUbat1tutodD
Minocartaonyloxy- (oonorfe)
Nolonltroboraoie acid. Mtetltutod (gonorle)
Phosphoric tcld.1,2-«th«nadlyl totraki»(2-chloro-1-
•Bthylothyl) octor
Alkyl peiwv-2-tttiyl hoxanoato (ovwrle)
SiAstltutod dfalkyl oxuolont (gomrie)
Bonsom. subttltutod alkyl ocrylato dirivitiwo (gcntrle)
SUtatttutod taonzonodlcartexyllc acid, (polyolkyl
•erytato) dtr<«ati«« (aonoric)

AiKyiDitoxyoiKyt iHBniniioa*i(i-ai>iniyioTiiyipnonyii
taoncotrinol* (amtrie)
NotliytorMbf«tr1subBt-Darthvlonabia(oi(y-2.1-otliafwdiylth1o)lb1a-
EpoitdlMd Bolvbutona
•Itrophonoaylalfcanolc acid sitetltutod thiaslno hydruida
(oonorlo
Poly(attetitutod trlatlnyl) piparailne (oanarie)
•ydrMlnacaito»ai1da,M(B]'-OBatliylonadi-4.1-plianylono)b1a
12.2-diMthvl-
Boactian product of a •anoalkyl aueelnie anhydrida with a

BULECOOE
•61
•65
•Jlf

•64
•n
•62
•6S

•66
•63
063
a68
*&9
•OC-
063
•63
•62
•63
•63
061
861
•70
•63
•63
•63
•62
•62
066
061

                         12
                                                                     (10/31/91)
-------
    CHEMICALS ON REPORTIHG RULES (COM) DATABASE



PIENANUrACTURE HOT ICE (PNM) MJNUIS t CHEMICAL NAMES
PMH NUMBER
88-831
88-837
88-864
88-972
88-1211
88-1271
88-1Z72
W-J27!
88-1274
88-1308
88-1440
88-1540
88-161*
88-1617
88-1690
88-1691
88-1733
88-1703
88-1889
88-1898
88-2177
88-2179
88-2180
88-2181
88-2188
36-2380
88-2463
CHEMICAL MANE
MMnal.4.4>-(9H-flueren-9-yltdane)ble.
Diolycidyl ether of dieubstftuted carfaopolyeycle
(generic)
Phenol .4.4i-e»thyleniBie(2,6-dte»thyl)
3.3'.3.5'-Tatraa»thylb
ratty acid, asilne eelt (generic)
7-Oub1cycle(4.1.0)heBtane, 3-ethenyl. hosapelyaar ether
nith 2-ethyl-2-(hydre»ya»thyO-1.3-prepened1ol (3:1)
epexldind
Ethane. 1.1-dichlere-l-fluere-
Oxlrena. 2.2'-(1.6-heunediylb
-------
    CHEMICALS OH lEPCRTIHG HJIES (COM) DATABASE



PtENANUFACTUU HOT ICE (PNN) NUNKM t CHEMICAL NAMES
PMN MUMBEI
88-2470
88-2540
88-2566
88-2582
89-30
89-31
89-73
89-77
89-336
89-396
89-422
89-423
89-424
89-448
89-483
89-507
89-539
89-576
89-577
89-626
89-632
89-651
89-672
89-676
89-694
89-697
CHEMICAL HANI
Alkyl alkamsta. aiobia- (Mfwrfc)
Nitrate polystlwr polvot (ganarle)
SiAstltutsd exida-alkylane pelywr. Mthacrylate

Maphanal and 2.2-t(1-Mtnylathylidana)Jbla(4.1-
pnanylenaoiyMthylana)] blaoxrane. graft
2-Propamic acid, 2-Mthyl-. 7-«ubfcyclo[4.1.0] hopt-3-
yl-atnyl aatar
2-Brapanslc acid. 7-oxabieyclo(4.1.0l hapt-3-ylHthyl
aatar
PolyMr of alkyl carboaanocycla dffaoeywata with
•Ikanapelvol oelyaerylat* (oentrie)
Alkyl idcareoxylie acids, polywrs with alkanapolyel and
TOI. alkanol' bleckad. aerylata (ganarfc)
Alanlna. •-(2-earbaxyatliyl)-N-alkyl. aalt (gtntrfc)
SulBhur-brldoad cubatltutad phanela (aanarfe)

Z-Prepanofe acid, 2-avtnyl-( i-i-diaMnyiatnyi astar (au
t-Butyl wthaerylata)
Polyalkylpolyailaxarw, biXaubatltutad aerylata)
(ganarle)
Carbaarfe acid (tHalkyloxy>Uyalkyt)-sutatitutad acrylat*
aatar (ganarle)
Alkane polyol phoaBkatt aatar (aanarle)
talyalkylanapolyel alkylaailna (ganarle)
Nydroxyalkyl Hthaerylata. alkyl aatar (ganaric)
HarlrJMMI 9 99m f^ AwlhAVgMldBrllirlfralalfAVWaBBrikrtewldHPadkl^Kial

Natal aalt of Inarganle exyaeid
Natal aalt of eoaptox Inorganic oxyacid
AlkylanablaCaitetltutad earbaaonecyela).
aptchlorohydrln, diaubatltutad hataroMnaeyelOf aerylato
1.1 rrnpanartl»»lnB.8.M' 1.T attianartlylhla |ml>Mi nith
2.4.6-tr1ckloro-1f3,5-triat1na. raoetlan products tilth •-
butyt-2.2.6.6-totraHthyl-4-1 plparldiiwina
PfMnol.4.4<-(oxvb1a(2.1-athanadlylthle)bli-
Alkanole acid, tautmadiol and cyclohaunealkanal polyaw
(ganerle)
Olatlllataa (patroloua). C(3-6>. polyvra with atyrana
and arixad torpanea (ganeric)
Alkanole acid, trlsitatltutad phanylalkyl dlaitetitutad
phanyl astar

astar (ganaric)
RULE CODE
•M
a«2
•61
a63
866
866
861
•61
•70
862
•61
861
861
•57 - aao also COM
lUtlngs 6/30/90 (HT)
•63
861
871
863
a63
an
•63
•65
862
•62
861
861
                         14
                                                                       (10/31/91)
-------
    CHEMICALS ON REPORTING IULES (COM) DATABASE



PRENANUFACTURE NOTICE (PM) MMKIS 1 CHEMICAL NAMES
PNN NUMBER
89-708
89-711
69-726

W*/*V
89-790
89-760
89-769
89-776
BO-RIO

dM.Mjt

89-837
89-8U
89-906
89-946
89-998
89-1056
89-1062
89-1072
89-1081
89-109S
89-1104
89-1135
90-113
90-212
90-244
CHEMICAL NAME
tulfuriud elkvlahemU (ooneric)
Benxone,1,2-dfa»thyi-f polypropone derivative*.
•ulfeneted. potBMlu* Mlts (oofwlc)
Poiyaw of adipic acid, •Ikmpelyel. alkyldlloo
eyonotocorboeonocyclo. hydroxyalkyl ocrylate eater

polycaproloctono triol and •Ikoxylatod olkanepolyol
hydroxyilkyl •athaerylat* ttttr (gwwrle)
Blsptianol A, aplehlerohydrln, polyalkylvHpolyol and
Dolvfaocvanato darfvatiwa (ganarle)
taaetien product of •Iknnadiol and apldilerehydrin
(qowrle)
Msorclnol, foraaldahyda, attatltutad carhoaanocycta
rnin (generic)
Sutatltutad banunttulfenie acid, alkali aatal Mlt
(Mfwrle)

diglveldyl athar (ganarlc)

atlwr (ganaric)
Phoapnerylatad eaprolactona alkyloxahataroaanocycta and
polvalkylana polyol alkyl athar (ganarle)
1.3.5-Tr1azlna-2.4.6-trlaiina. hydrabraufde
Silana. (l.l-dlarnnylathexyMlMtnoxy (2-aMhyl-propyl)-
Caprolactana. polyaw with hauamhylana dKaocymta.
hydraayalfcyt acrytata aatar, reaction products Mith
aubttltutad alkanoic acid and a»tal hataroamacycla
(gonarle)
Polysraaatlc urathana (ganarlc)
Aliphatic polyilycidVl aatar (generic)
Adda of polyaaina and organic acid (generic)
Oxyalkanepolyol polyecrylate (generic)
Reaction product of alkyl earboxyllc acide, alkam
polyeU, alkyl acrylata. and iaopherona diiaocyanato
(generic)
••^•fe^^lA ^^h^^^^dltfl a^B^l^h.
Necnane. oroaaaiTiuoro*
•olyvr of eubatitutod phonal. forMldehyde,
opichlorohvdrin. and d'wAetltutod benzene (generic)
2-*roponolc acid Coctahydro-4.7-eMhene-1N-lndene-1.5(1,6
or 2.3)-dtyllbU(eetnylano) eater
Toluene aulfonaaiide taifpnonol A tpoxy adduct (generic)
Ethane. 1.1-dichlore-1-fluoro-
Polyaer of bliphenol A dlglycidal other, st^etitutad
olkenea, and butadiene (generic)
RULE CODE
o«5
870
065

061
•66
•66
•69
•70
mAJL

mA9

•62
•65
•66
•61
•66
•65
•65
•71
•71
•71
•71
•71
•70
•70
•70
                         15
                                                                       (10/31/91)
-------
    CHEMICALS OH REPORTING RUIES (COM) DATA1AK



MBHNUFACTUU HOT ICE (Ml) MMIM ft CHEMICAL MANES
MM MJMKI
90-2*5
90-27*
90-299
90-333
90-335
90-38*
90-440
90-456
90-401
90-489
90-549
90-583
90-584
90-587
90-643
90-667
90-668
90-1285
90-1393
CHEMICAL NAME
Polyw of btaphanal A diglycidal other. Mawtitutod
•Ikenoa. and butadiene (generic)
DialkylMino aklanoate. a»tal salt (generic)
Kaloganatod acrylonitrilo (generic)
2-Proptnofc acid, 2-a»tbyl-.2-l-J-(2H-ber«otr1axol-2-yl>-
4-hydroxyahonoll ethyl eater
2-fctetltutid bmetrlitol* (ganarle)
Phosatiorie acid, CA..,-alkyl aattra, coapmnd Mith 2-
(dtbutylMino) •thinet
Sutat-(1-
oMhylottiylidono) bist2.6-dlbro»aphiiiBll . diwthaerylato
RULE CODE
•70
•70
•70
•71
•71
•71
•71
•71
•70
•71
•70
•70
•71
•70
•71
•71
•71
•71
•71
                        16
                                                                    (10/31 /
-------
                   CHEMICALS 0       TING RULES (COM) DATABASE



RULE CODE. CODE OF FEDERAL REGuuniuii    ), AND FEDERAL REGISTER (FR)  INFORMATION
RULE
CODE
dZ8
428
428
d28
428
dZ8
 (HCFC-
1S3a)
2.2-Dlchlero-l.l.l-trltluoroathana
(HCFC-I2S)
Pentafluoroathant (NFC-125)
1.1,1.2-Tttrafluorotthane (HFC-134a)
1.2-DlcMoro-1.1-dlfluoroethane
(HCFC-1S2b)
1,1-Dlchloro-1-fluoroethane (HCFC-
Ulb)
2-Chloro-1.1,1.2-tetrafluoroethane
(HCFC-124)
Certain Chemical Substance*
SlgnUlcant Hen Use Rule and Addition
to Neelth and Safety Data Reporting
Rule



40 CFR
Cl TAT IOH
716
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716
716.120
716.120
716.120
PRO-
FUSED
RULE
DATE












PROPOSED
RULE FOR
CITATION












FINAL
RULE FOR
CITATION
SS FR
3S628
SS FR
35628
SS FR
35628
J5 FR
3S628
55 FR
3S628
SS FR
35628
SS FR
15628
SS FR
35628
SS FR
39774
SS FR
39774
SS FR
39774
SS FR
39774
FINAL
RULE
PURLIM
DATE
8/S1/90
8/31/90
8/31/90
8/31/90
8/31/90
8/31/90
8/31/90
8/31/90
9/28/90
9/28/90
9/28/90
9/28/90
EFFEC-
TIVE
DATE








10/1S/90
10/1S/90
10/1S/90
10/15/90
REPORT-
IRQ
DEADLINE
DATE












SUNSET
DATE
10/15/90
10/1S/90
10/15/90
10/15/90
10/15/90
10/15/90
10/15/90
10/15/90
t »
10/15/00
10/15/00
10/15/00
NOTES
EPA It adding eeven potential
CFC •UDBtltutee te the Health
and Safety Data Reporting Rule
(40 CFR Part 716) and for tue
of these substances. EPA la
proaulgatlng a SNUR.
Ethane. 2-chloro- 1.1.1 -
trlfluoro (CAS No. 75-88-7).
Ethane. 2.2-dlchloro-1.1.1-
trifluoro- (CAS No. 306-83-2).
Ethane, pentafluoro- (CAS No.
3S4-33-6).
Ethane. 1.1.1.2-tetrafluoro-
(CAS Ho. 811-97-2).
Ethane. 1.2-dlchloro-1,1-
dlfluoro- (CAS No. 1649-08-7).
Ethane. 1,1-dlchloro-1-fluoro-
(CAS Ho. 1717-00-6).
Ethane. 2-chloro- 1.1. 1.2-
tetraf luoro- (CAS Ho. 2873-89-
0).
Correction: A table on pegea
3S631 and 3S632 of 55 FR Has
corrected to reflect effective
dates of rule end sunset
provisions 'for chealcals added
to the Health and Safety Data
Reporting Rule.
Ethane. 2-chloro- 1.1.1 -
trlfluoro- (CAS Ho. 75-88-7)
Ethane. 2.2-dlchloro-1.1.1-
trlfluoro- (CAS Ho. 306-83-2)
Ethane, pentafluoro- (CAS No.
3S4-33-6)
                                                                                                               (10/31/91)
-------
                   CHEMICALS ON REPORTING RULES (COM) DATABASE



RULE CODE, CODE OF FEDERAL REGULATION (CFR).  AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
-------
                   CHEMICALS I        IIBC RULES (CORR) DATABASE



RULE ODE. CODE Of FEDERAL RECULATIOk     j. AND FEDERAL REGISTER (FR) INFORMATION
RULE
COM
d29
029
029
029
d29
029
dZ9
029
dZ9
dZ9
429
•ME W RULE
Preliminary Aeniaamt
Intonation ml Heal* nd
Safety Data Reportlnji Addition
Of ChOBlcala
Sodlui cyanide
Itocyanotoo
leocyanatee
leocyenatea
loocyenotea
Uocyonotn
leecyonatee
Incyonatot
laocyimtoo
Itocyonotot
40CFR
CITATUM
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
PRO-
POSED
RUE
DATE











PROPOSED
RULE FOR
CITATION






.




FINAL
RULE FOR
CITATION
5$ n
59780
55 FR
39780
55 FR
39780
55 FR
39780
SS FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
FINAL
RULE
PUUISN
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
DATE
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
REPORT-
INS
DEADLINE
DATE











SUNSET
DATE
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
NOTES
Final Rulot Add oUbBtonco ond
cateflorlea to tue endel Inforaati on-
set her Ing ruin; TSCA Section 8(0}
PAIR ond TSCA Section 8(d) Health
end Sefety Dete Reporting.
Specifies eubetoncca ond lie ted
•iMturee eubject to rule.
Scdlua cyanide (CAS Re. 143-33-9)
p-Nltrophenyl leocyenete (CAS Ho.
100-28-7)
3.4-Dlchlorophenyl leocyenete (CAS
Ho. 102-36-3)
Phenyl Isocyanete (CAS Ho. 103-71-9)
p-Chlorophenyl leocyonate (CAS No.
104-12-1)
Ethyl liocyenate (CAS No. 109-90-0)
n-Propyl leocyanato (CAS No. 110-78-
1)
n-Butyl leocyenete (CAS No. 111-36-
4)
Octedecyl leocyenete (CAS Ho. 112-
96-9)
(elphe. elphe, elphe-Trlfluoro-a-
tolyl) leocyenete (CAS Ho. 329-01-1)
                                                                                                                OO/31/91)
-------
                   CHEMICALS OH REPORTING RULES (CORK) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
dZ9
d29
d29
079
dZ9

thlophowhato (CAS No. 4151-51-3)
1.1'.1"-NothylfoYiwtrU(4-
iMcymto-btniene) (CAS No. 2422-
91-5)
DIphonylMthyltm dllncymto (CAS
No. 10031-75-1)
•U(lBocywwtoMthyl) btnim (CAS
No. 25854-16-4)
I.S.S-TrUU-lsocyMMtOMttiylphenyl)
1.3.S-trUilra-2,4.6 (IN. JH, 5N)-
trlone (CAS No. 26603-40-7)
2,6-01 Uopropylphmyl Uacyarato
(CAS No. 28178-42-9)
-------
                   CHEMICALS d       IIHG RULES (COM) DATABASE



MILE CODE. OK OF FEDERAL REGULATION     I. AND FEDERAL REOISTER (FR) INFORMATION
RULE
CODE
dZ9
d29
d29
d29
429
429
d29
d29
d29
d29
429
429
429
429
dZ9
NAME W RULE
iMcymtw
ItocyuwtM
iMCymtM
iMcymttt
iMcyaratm
IsocywotM
Broalrated Float ••tankntt
•rmlMtad Flow RttardMiU
•roilnotod Float Rttordwts
••IM|M»MR>«M| RTfl*^Rto •talaitflWilRl

••iflMlMoBOXMfl rli^M ••tiartfteitiBi

•rwlmttd FlMi Rttardnts
•roilMt«d Flwt RttardMits
Iroalratcd Htm Rttantonts
•r«ilMt«d Flw* RtUrdanU
40CFR
CITATIOM
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
716.120
PRO-
POSED
RULE
DATE















PROPOSED
RULE FOR
CITATIM








•






FINAL
RULE FOR
CITATION
» FR
39780
S9 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
FINAL
RULE
PUBLISH
DATE
9*28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
OAK
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
REPORT-
ING
DEADLINE
DATE















SUNSET
DATE
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
10-29-00
NOTES
TetiMiw dllMcyMMt* dlatr .5-TrlbranMllcylmllldB (CAS
No. 87-10-5)
2.3.4,5.6-Pmtibrantoluciw (CAS No.
87-83-2)
19 t A ^ PmtjKrjuj < .
chtorocyclotMura (CAS Ho. 87-84-3)
2.3-Dtbranproponol (CAS No. 96-13-
9)
Vlnylbraildt (CAS Ho. 593-60-2)
2f4-DlbroBafteml (CAS Ho. 615-58-7)
EthoityUtod tctrobroMblapticnoi A
(CAS Ho. 4162-45-2)
TotrabroMblaphonol A. bU(«llyl
othtr) (CAS No. 25327-89-4)
TvtrobronadlcMarocyclaheMm (CAS
No. 30S54-72-4)
                                                                                                                 (10/31/91)
-------
                   CHEMICALS OH REPORTIHG MULES (COIR) DATABASE
mac COPE,  CODE OF  FEDERAL REOULATIOH . ABO FEDERAL REGISTER  IHFORNATIOH
RULE
CODE
dZ9
d29
-Olbraaofrfianol.
hMOpolyiwr (CAS Ho. 69882-11-7)
Rciuana, athanyl-. hoanpolywr,
bronlnatcd (CAS No. 88*97-56-7)
Trlathyl phoaphata (CAS No. 78-40-0)

78-42-2)
Dlbutyl pheaphata (CAS No. 107-66-4)
Trllaobutyt ptiocptiato (CAS No. 126-
71-6)
trlbutyt phoaphata (CAS No. 126-73-
8)

VMc-ainyinaMyiipnoapnaia (ma ao.
298-07-7)

MnBMinyi pnotpnaia ion no. BIC-
00-0)
Trla(2-buta>yathyl)phoaphata (CAS
No. 78-51-3)
Nono(2-athylhuyl)phoaphata 70 (CAS
No. 1070-03-7)
Ethyl dlchlorophosphata (CAS No.
U98-S1-7)
-------
                  CHEMICALS DM




RULE COOt.  COM OF FEDERAL
ING MILES (COM) DATABASE



   ). MB FEDERAL REBISTER (FR) IkFOMUTIM
RULE
CON
d29
079
039
dZ9
dZ9
dZ9
-------
                   CHEMICALS ON REPORTING RULES (CORR) DATABASE



RULE CODE, CODE OF FEDERAL REGULATION (CFR).  AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE


dSO
















030















NAME OF RULE



Preliminary Assessment
Information and Health and
Safety Data Reporting; Addition
of Chemicals














Preliminary Assessment
Information and Health and
Safety Data Reporting; Addition
of Chemicals; Technical
Amenduent












40 CFR
CITATIO*


716.120
















716.120















PRO-
POSED
RULE
DATE

































PROPOSED
RULE FOR
CITATION


































FINAL
RULE FOR
CITATION

56 F8
42688















56 FR
59146














FINAL
RULE
PUBLISH
DATE
8-29-91
















9-27-91















EFFEC-
TIVE
DATE

9-30-91
















9-30-91















REPORT-
ING
DEADLINE
DATE
11-27-91
































SUNSET
DATE


9-30-00
































NOTES



The Interegency Testing Com*ltteo
(IK) In Its Tusnty-soventh Report
to EPA revised the Toxic Substances
Control Act (TSCA) Section 4(o)
Priority Llat by designating tuo
chemical substances that Mere
previously In the •ricomminilsil nlth
Intent-to-deslgnste" category and by
adding one chemical substance and
four categories of chemical
substances. EPA Is adding the
substance end the four categories to
tiio model Information-gathering
rules: the Toxic Substances Control
Act(TSCA) section 8(e) Preliminary
Assessment Information Rule I «••!•>
end the TSCA section 8(d) Health and
Safety Data Reporting Rule.
This notice corrects an error In a
final nil* published In the Federal
Register of August 29. 1991.
concerning six chemlcala Mtilch Mere
Inadvertently Included for reporting
among the chemicals sddsd to the
1818 category fort In 1 716.120(d)
the folloMlng chemicals under the
1818 category are removed; acrylic
acid (CM. 80 79-10-7). acetophenone
(CM 80. 98-86-2). N.N-
dlwthylmnlllne (CM No. 121-69-7).
ethyl acetate (CAS No. 141-78-6).
2.6-dlmethytphenol (CM No. 576-26-
1). end under the category
Sulphones, the substance Blsphenol A
Is revised to read Blsphenol S.
-------
              CHEMICALS 01
                         I



CODE. CODE W FEDERAL REOU
RULES (COM) DATABASE



). AND FEDERAL REGISTER (FR) IMFORMTION
MILE
CODE
14















NAME OF RULE OR FW *
InfoTMtlonel Notice on the
Interogency Chlorinated Setvente
Project, Notice.













40 CHI
CITATION
















PRO-
POSED
RULE
DATE
















PROPOSED
RULE FOR
CITATION
















FINAL
RULE FOR
CITATION
S6FR
24811














FINAL
RULE
PUBLISH
DATE
S/Sl/91















EFFEC-
TIVE
DATE
















NOTES
TMs notice Is provided to updsto the activities of
the Chlorinated Solvmto Project. The Chlorlneted
Solvents Project nee Initiated In IMS by EPA In
rMBOHM to concerns tilth the UM of Mthylene
cMerldt (DCN. CAS No. 75-09-2). end eipeiided to
Includv four Federal agencies Investigating ell
•ojor chlorlneted sol vent • In four high-use
csiegorlra. DCN, Ito focus expanded to Include the
folloMlng solvent cheeilceU de«sed possible
substitutes for DCN> trlchloroethylene (TCE. CAS
No. 79-01-6); perchloroethylene
(tetrechloroethylene. PCD. CAS No. 127-18-4); 1.1.1-
trlcSiloroathane (evthyl chlorofons. TCA. CAS No. 71-
5J-6); carbon tetrachlorlds (CAS No. S6-23-S); and
1.1,2-trlchloro-1.2.2-trlfluoreethsne (CFC-11S, CAS
No. 76-1S-1).
                                                                                                          (10/31/91)
-------
                  CHEMICALS ON REPORTING RUIfS  nn»Bi  • •»• I




MILE CODE.  CODE OF FEDERAL REGULATION (CFR).  AND FtOItU "KISKi ('•>   • • —•   -
RULE
CODE
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
I
P24
P24
P24
MIC OF RULE
Preliminary AMMMtnt
Inforwtlon and Health and
Safety Data Reporting: Addition
of ChMlcala
Sodlw Cyanlda
laoeyanataa
laocyanatea
Itocyenatea
laocyenatea
Isocymate*
laocyanatat
laocymataa
laoeyanatat
Itocyanatat
laocyanatot
laocyanatat
laocyanataa
40 CFR
CITATKM
712
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
PRO-
POSED
RULE
DATE














PROPOSED
RULE FOR
CITATION














FINAL
RULE FOR
CITATIOi
55 FR
39780
55 FR
39780
55 FR
397M
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
FINAL
RULE
PUBLISH
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
DATE
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
REMRT-
IH6
DEMURE
DATE
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
NOTES
Final Rulo: Adda ona aubatanea and tfirao
categorlM of aitetancee (tilth 76 Individual
•aitetaneaa Identified) to the PAIR; apaclflaa
dmlcala and reporting periods.
Sodlua cyanide (CAS Ho. 143-33-9)
4.4'-Dlleocyanato-3.3'-dlmthylblpnenoi (CAS
•o. 91-97-4)
p-Hltrophenyt faocyanate (CAS Ho. 100-28-7)
4.4>-Dlptienyto»thane dflaocyanate (CAS Ho. 101-
68-8)
3,4-Dlchlorophenyl Uocyanate (CAS No. 102-36-
3)
Phenyl laocyanate (CAS Ho. 103-71-9)
p-Chlorophenyl Itocyanate (CAS No. 104-12-1)
p-Phanylene dllaocyanata (CM No. 104-49-4)
Ethyl iMcyanato (CAS No. 109-90-0)
n-Propyl laocyantta (CAS No. 110-78-1)
n-Sutyl Uocyanate (CAS No. 111-36-4)
Octadecyl Uocyanate (CAS No. 112-96-9)
1.3-DIUocyanatobeniena (CAS Ho. 123-61-5)
-------
                   CHEMICALS 0



MILE CODE. ODE Of FEKUL REb
ING RULES (COIR) DATABASE



    >. AM) FEDERAL REGISTER, 
-------
                   CHEMICALS OH REPORTING RULES (COM) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
NAME OF RULE
iMcywwtM
Kecywwttt
Itecymtn
IsocymtM
iMcywwtn
Uocyvwtoi
IsocyMwtes
Uocywiotei
iMCyttMtM
laocyanotM
iMcyonotOB
1 oocyinotofl
Itocymotts
BroBlMtod Flw Rttordvito
40 CFR
CITATION
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.M
PRO-
POSED
RULE
DATE









-




PROPOSED
RULE FOR
CITATION














FINAL'
RULE Mi
CITATION
SS FR
»ra
39780
SSra
39780
SS PR
39780
ss ra
39780
SS FR
39780
ss ra
39780
ss ra
39780
ss ra
39780
SS FR
39780
ss ra
39780
ssra
39780
ssra
39780
ss ra
39780
FINAL
RULE
PUBLISH
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-18-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
OATE
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
REPORT-
ING
DEADLINE
DATE
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
NOTES
DlpbtnylMthylww dllMcymto (CAS No. 10031-
71-11
1,«-DfiMcyonoto-2.4.4-trlMtliylliMMio (CAS No.
1S646-96-S)
1,6-DllMcyiMto-2,2.4-trlMthylhtMn> (CAS No.
16938-22-0)
OlsdMcymtOMthyt) bm«w (CAS No. 25854-
16-4)
1t1'-NMliyl«Mbls-(lMeyMMtob«uctw) (CAS No.
26447-40-S)
1,3,S-TrU(3-Uocywwt 1.5.5-
trUilrw-2.4,6 (IN. 3N. 5H)-trtww (CAS No.
26603-40-7)
Tolutnt dllwwyMWto d\mr (CAS No. 26747-90-0)
2,6-Dti«opropylpii
-------
                   CHEMICALS 0       TING RULES (CORK) DATABASE



MILE CODE. CODE Of FEDERAL REOuuuiwi     >. AND FEDERAL REGISTER (Ft) INFORMATION
RULE
CODE
mm*
rM
P24
P24

PZ*
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
NAME OP RULE
•r nt»i nmt jjj HOBNOB ••f/Nirg^Mnrai

Oroalnotod Urn* Rotardarta
Broalnotod Flaw Rotorosnti

•roBinoioo MOJB moraonio
Broalnotod Flan Reterdonto
Nroalmtod Flaw RoUrdentt
NroBlneted Fl«w Retordonto
Brealnotod Floi* ReterdanU
Broalnotod Flaw RetordenU
Broalneted Ftaa> Reterdente
BroBlmtod Flaw RtUr*nta
•realMtad Flan Rttardmtt
IroalMtMl Flaw RttcnhnU
•raalMtad Flaw Rctardaitt
•roalratcd Fla» RatsritenU
AUyl Phosphate*
40CFR
CITATIM
Win

712.30
712.50
Win

712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
PRO-
POSED
RULE
OA1E













•




PROPOSED
RULE FOR
CITATION


















FIRM.
RULE FOR
CIMTIW
MM
r«
39760
SS FR
39780
SS FR
39780
»>•
39780
SS Ft
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
SS FR
39780
55 FR
39780
FINAL
RULE
PUBLIU
DATE
O_M_M
T'CO'VU
9-28-90
9-28-90
O*M*M

9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
OATE

1H-CV-VH
10-29-90
10-29-90
4A.9O.OA

10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
REPORT-
ING
DEADLINE
DATE

-«f-W
12-27-90
12-27-90
«.9*_OA

12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
NOTES

,4' ,5-TrloroaoMl Icylail 1 In (CAS No. 87*10-5)
2.3.4.S,6-P«ntibraM)toluaw (CM No. 87-83-2)
1.2.3.4.S-Ptntobreao-«-chlorocycloiitiiom (CAS
No. 87-84-3)

(j'DiDroMopropofioi |uu m. VDMJ*VJ
Vlnylbnaldo (CAS No. S93-60-2)
2.4-Dlbroaophml (CAS No. A1S-S8-7)
EthwyUtcd totrabraMbl •phenol A (CAS Ho.
4162-4S-2)
TttrobroBobltphtnol A, bU(ollyl other) (CAS
No. 2S327-89-3)
TotrabroaodlfAlorocyclohoMno (CAS No. 30554-
72-4)
TrlbroMtrlchlorocyclohcMne (CAS No. 30554-73-
S)
Trlbraagnoopentyl alcohol (CAS No. 36483-57-5)
Tetrebranbltphenol A dlocrylete (CAS No.
55205-38-7)
Albinos. C,0.,.. breao chloro (CAS No. 48955-
41-9) 10 "
2.4- (or 2.6-) DlbroKvhenol. hoaopolyMr (CAS
No. 69882-11-7)
Bentene. ethcnyl-.hoonpolywr. broalrated (CAS
No. 88497-S6-7)
Trlethyl phosphate (CAS Ho. 78-40-0)
                                        13
(10/31/91)
-------
                   CHEMICALS ON REPORTING MILES (COW) DATABASE



RULE CODE, CODE OF FEDERAL REGULATION (CFR), AW FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
P24
NAME OF RULE
Alkyl Phosphates
Alkyl Phosphates
Alkyl Phosphates
Alkyl Phosphates
Alkyl Phosphates
Alkyl Phosphates
Alkyl Phosphate!
Alkyl Phosphates
Alkyl Phosphates
Alkyl Phosphate*
* I |*ul *^--^— *.— m. 	
III Kyi HMM|IMCn
Alkyl Phosphates
Alkyl Phosphate*
Alkyl Phosphate*
Alkyl Phosphate*
Alkyl Phosphate*
40 CFR
CITATION
712.30
712.30
712.30
712.30
712J.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
712.30
PRO-
POSED
RULE
DATE
















PROPOSED
RULE FOR
CITATION
















FINAL
RULE FOR
CITATION
Sf FR
55 FR
55 FR
39780
55 FR
39780
59 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
55 n
39780
55 FR
39780
55FR
39780
55 FR
39780
55 FR
39780
55 FR
39780
FINAL
RULE
PUBLISH
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
DATE
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
10-29-90
REPORT-
UN
DEAPLI8E
DATE
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
12-27-90
NOTES
Trls(2-ethylhoiyl) phosphate (CM 80. 78-42-1)
TrU(2-but«y*thyl) phosphate (CAS He. 78-51-3)
Dlbutyl phosphate (CM No. 107-64-4)
TrllMbutyl pho*ph*t* (CM No. 126-71-6)
Trlbutyl phoiphoto (CM No. 126- 73-8)
OI(2-ottiylhMyl) phosphate (CAS No. 298-07-7)
NonoMthyl phosphate (CM No. 812-00-0)
Nono(2-othylhoiiyl) phosphate 70 (CM No. 1070-
03-7)
Ethyl dlchlorophosphate (CM No. 1498-51-7)
Nonobutyl phosphate (CM No. 1623-15-0)
NomXlsopropyU phoophaU (CM No. 1623-24-1)
NoMoctMkwyt phoiphoto (CM No. 2958-09-0)
Nonohuyl phosphate (CM No. 3900-04-7)
Nomoctyl phosphate (CM No. 3991-73-9)
Oldodtcyl phosphate (CAS No. 7057-92-3)
2-(2-Buto>yethny)ethanol phoiphoto (3:1) (CAS
No. 7332-46-9)
-------
                   CHEMICALS OH       ING RULES (COIR) DATABASE



MILE ODE. CODE OF FEDERAL  UOJuinwi     J. AM FEDERAL REGISTER (FR) I1FORIUIIH
RULE
CODE
P24
PM
P24
•ME OF RULE
Alkyl PhosphitM
Alkyl PtiMphitM
Atkyl PhoMMtM
40CFH
CITATION
712.30
712.10
m.so
PRO-
POSED
RULE
DATE



PROPOSED
RULE FOR
CITATIOM



FINAL
RULE FOR
CITATION
» FR
19780
59 FR
19780
» FR
19780
FINAL
RULE
POLISH
DATE
9-26-90
9-20-90
9-28-90
EFFEC-
TIVE
DATE
10-29-90
10-29-90
10-29-90
REPORT-
IHO
DEADLINE
DATE
12-27-90
12-27-90
12-27-90
NOTES
2-EttiylhMyl 0MM|4uU (CAS No. I2M9-S1-7I
Dedtcyt phoMwt* (CAS No. 12151-21-4)
DIlMOCtyl phosfhat* (CAS No. 27215-10-7)
                                        15
                                                                                                               (10/31/91)
-------
                   CHEMICALS OH REPORTING RULES (CORR) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION (CFR).  MB FEDERAL REGISTER  (FR)  INFORMATION
RULE
CODE


MS















P25













HANE OF mil OR rm t



Preliminary Aaeaoaeant Information
and Health and. Safety Data Reporting;
Addition of Cheatcala '













Preliminary Asaeaimant InfenHtlon
and Htalth and Safety Data Report Ins;
Addition of Oievlcale; Technical
AMndamt'










40 CFR
CITATION


712.30















712.30













PRO-
POSED
RULE
DATE






























PROPOSED
RULE FOR
CITATIOI































FINAL
RUU FOR
CITATION
i
56 FR
42688














56 FR
49146





,






FINAL
RULE
PUBLISH
DATE
8/29/91















9/27/91







'





EFFEC-
TIVE
DATE

9/30/91















9/30/91













REPORT-
INS
DEADLINE
DATE
11-27-91





























NOTES



The Intorageney Tooting Conttteo (ITC)


revlaed the Toxic SUbatencea Control Act
(TSCA) Soctlon 4(o) Priority Llet by
designating tm choilcal oubatonceo that
Hero provloualy In the "racoomanifcrt with
Intent- to-doalgnate" category and by
oddlng one chemical eubetenco and four
categorlea of chemical subatancea. EPA
lo adding the aubetance and the four
categoriea to tM andal lnfore»tion-
gathering rulea: the To>lc Subatancea
Control Act (TSCA) eectlon 8(a)
Preliminary Aaaeaannt InforMtlon Rulo
(PAIR) and the TSCA aectlon 8(d) Health
and Safety Data Reporting Rulo.
Thla notice corrects an error In o final
rule published In the Federal Reglater of
Auguat 29. 1991. concerning atx chealcala
Mhlch Mere Inadvertently Included for
reporting Hang the cho»lcala added to
the IRIS category fort In I 712.3000
the folloMlng cheilcele under the IRIS
category aro raa«¥edi acrylic acid (CAS
No. 79-10-7), acetophonone (CAS No. 98-
86-2), pbanol (CAS No. 108-95-2). N,N-
dlavthylwIIlM (CAS No. 121-49-7), ethyl
acetoto (CAS Ho. 141-78-A) 2,6-
dleathylplnml (CAS No. 576-26-1), and
under tho catogory Sulphonea, the
aubstanco Blaphenol A la revlaed to rood
Sltphono! S.
-------
                   CHEMICALS C        UNO MILES (CORK) OAIABASE



MAI CODE. CODE Of FEDERAL REbiumwi     I. AW FEDERAL REOI8TEI (FR) INFORMATION
MILE
CON


rl






rl
















rJ



rS




•AM W HUE



l-Propantarina, N-propyl






Aroa»tlc Co fraction from Potroleua
Refining















Solvent Naphtha (Potroleua) Light
AroMtlc


Cerrtctlon of Lnt Chealcal Substance
Under Alkyltln Ceapoundi



40 C»
CITATION


716.120
<•)





716.120
(b)















716.120
(•)


716.120
(0



PRO-
POSED
MU
DATE

































PROPOSED
MM FOR
CITATUM


































FIRAL
MILE FOR
CITATIM

SSFR
S66U




I
SS FR
S66U















SS FR
36638


SS FR
36638



FINAL
RULE
PURLISH
DATE
0/6/90






9/6^0
















9/6/90



9/6/W


.

EFFEC-
TIVE
BATE

5/7/86






12/S/90
















2/13/84



12/S/90




IgPORT-
IUG
DEADLINE
DATE

































SUHSET
DATE


12^/90























2/11/94





,


ROTES



Tcnilratlon of reporting •


proprl (CAS Mo. 142-84-7).
This action radnlgrattt
•roMtlc C. fro* • •liturc to •
tttetmo. Mklng • technical
•Mndhwit.
Reaoval of |716.120(b) entlro
•lutur* antry for aroaatlc C.
fraction frca patrolaua
refining and reserving
paragraph (b) -- (alao refers
to CORR Rule Code OS). CAS
Not. affected 95-63-6 (benicne.
1.2.4-trlMthyll. 108-67-8
(beniene. I.S.S-trlavthyl-).
S26-73-8 (benzene, 1.2.3-
trlMthyl-). 611-14-3 (beniene.
1-ethyl-2-Hthyl-). 620-14-4
(beniene. 1-ethyl-3-a»thyl-).
622-96-8 (beniene. 1-ethyl-4-
•ethyl). 2SSSO-14-S (beniene.
ethylMthyl-). 25551-13-7
(beniene. trlaethyl-).
Addition of Solvent naphtha
(petroleuO light aroaatlc (CAS
No. 64742-95-6) to I716.120(a)
(aea alao COU 6/30/90).
Correct now la •onoaethyttln
trle(leoocty()Mrceptoecetete
eke: acetfc acid. 2.21. 2"-
Knthylatannyl loVne)trla
(thlo))trlf. trllaooctyl eater
(CAS No. 54841-38-6).
                                       17
(10/31/91)
-------
                   CHEMICALS ON REPORTING RULES (COM) DATABASE



MILE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE


•21


•21

NAME OF RULE OR PMN •



8-Acetyt-3-dodecyl-7.7.9.9-
totreMthyl-t.3.8-trlo*o*0lre, C4.S1
decene-2.4-dlone; UltMrexol of
Proposed Significant New On Rule
P-83-370

40 CFR
CITATION


721.260


721.260

PRO-
POSED
RULE
DATE





PROPOSED
MILE FOR
CITATION






FINAL
RULE FOR
CITATION

56 FR
8171


56 FR
8171
FINAL
RULE
PUBLISH
DATE
2/27/91


2/27/91

EFFEC-
TIVE
DATE

2/27/91


2/27/91

NOTES



SNUR MM Nfthdram be«ed on tnt dtto «J»lttod
under tome of tlw Comnt Ordtr. Effcctlv* data of
revocation of SMtlon S(o) Consent Order MM
8/30/85.
••Acetyl-S-dodKyl-7.7.9.9-t«trmtliyl-1.>.B-
trleaesplro 14.51 dKene-2.4-dlane (PNN Re. 83-170).
-------
                   CHEMICALS 0        TING RULES  (CORK) DATABASE



IULE CODE. CODE Of FEDERAL REOULATTON    ). AND FEDERAL REOISTER (FR)  bHFORMATION
RULE
cow
•55
•51
•55
•ME OP nue o> PNN •
Ctruln chwlul SutaUncM.
Significant MM UM toil*
2-CMoro-l.l.l-trlfluoratfcm .
                                         19
(10/31/91)
-------
                   CHEMICALS « REPORTING RULES (COM) DATABASE



RULE CODE, CODE OF FEDERAL REGULATION (CFR). AND FEDERAL  REGISTER (FR)  INFORMATION
RULE
CODE


•57



aS7

NAME OF RULE OR PNN f
(


Alkana Polyol Phoaphato Eetar;,
Ravocatlon of a Significant Rm Uaa
Rula

P-89-448

40 CFR
CITATION


721.288



721.288

PRO-
POSED
RULE
DATE
2/27/91



2/27/91

PROPOSED
RULE FOR
CITATION

MFR
8172


MFR
8172
FINAL
RULE FOR
CITATION

MFR
4SB77


M FR
41877
FINAL
RULE
PUBLISH
DATE
9-3-91



9-S-91

EFFEC-
TIVE
DATE .

11-4-91



11-4-91

NOTES



EPA la revoking tha algnlf leant nan uao rulo CSNURI
•t 40 CFR 721.288 that MM proaulgatad under aactlon
S(o)(2) of tha Toxic Stftatancaa Control Act (T8CA)
for tha abova chaailcal aubatanco baaod on rocalpt of
nan data.
Alkana polyol phoaphata aatar Cotnarlc).

-------
                   CHEMICALS OH       ING RULES (CORK) DAIABASE




MJtE CODE. CODE OF FEDERAL REGULATION    ,. AND FEDERAL REGISTER 
-------
                   CHEMICALS OH REPORTING RULES (COM) 0»l««»M



RULE COOr.  CODE OF  FEDERAL REGULATION (CM), AND FEDERAL REGISTE*  if*)  INIOMUMCN
RULE
CODE
•59
•59
•59
NAME OF RULE OR PNN «
Cerbwy Alkyl Sllyl Salt and
Fonsaldehyde, Polyaw tilth Blaphenol
A and substituted Phenol; Proposed
Revocation of Significant Hen (toe
Rulea
P-89-279
P-89-292
40CFR
CITATION
721
721.1060
721.1890
PRO-
POSED
RULE
DATE
8/29/91
8/29/91
8/29/91
RULE Mi
CITATION
96 FR
42714
96 FR
42714
96 FR
42714
FINAL
RULE FOR
CITATION



FINAL
RULE
PUBLISH
DATE



EFFEC-
TIVE
BATE



NOTES
EPA la proposing to revoke algnlflcant new use
ruloa (SNURs) for tw choilcol substances boss* on
receipt of DM data. The data Indicate that for
purpoaea of TSCA section 9. further regulation
under section 9 of TSCA lo not Morranted at thlo
tlM. Urltten cooMnts oust bo sutaltted to EPA
by SoptMBtr 30* 1991*
Polyaw tilth Blophenol A and substituted Phenol
Cottony Alkyl Sllyl Salt
-------
                   CHEMICALS I



RULE CODE. CODE OF FEDERAL REl
TING RULES (CORRI DATABASE




     I, AND FEDERAL REGISTER M affect protection In the uorkplece; heterd
ccoeuilcatlon prograei; Industrial. cooMrclel. end
ccrauaer activities; disposal; and release to Hater.
Aroaatlc dl Mines (generic none), ilgnlficant new
uses affect protection In the vorkplace; hazard
coBounlcatlon progrM; Industrial, conaerclat, and
conswer activities; disposal; and release to Mater.
EPA la extending the consacnt period for a proposed
significant new use rule (SNUR) for tno arontlc
dlMlnes P-86-501 and P-86-50I. Written conent*
suit be sutMitted to EPA by August 26. 1991
                                                                                                                  (10/31/91)
-------
                  CHEMICALS W KPOITIN8 MAES (COM) DATABASE



MAE CODE. ODE Of FEDERAL KOULATIM (CFR). AM) FEDERAL REGISTER (FR) INFORNATION
MAE
CODE
•61
•61
•61
•61
•61
•61
1
•61 .
'1
•61
MANE OF MAE « UN i
Proposed Significant Hw Uses of
Ouailcal Substances
*
P-84-27
P-87-950
P-87-911
P-88-701 .'
P-88-2180
P-B8-246!
P-88-2S66
«OCFR
CITATION
72»
Sufepart
721.1710
721.1810
721. 18U
721.1282
721.607
721.1045
721.1290
PRO-
POSED
MAE
DATE
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
MAI FOR
CITATION
ssra
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
FINAL
MAI FOR
CITATION
55 FR
45994
55 FR
45994
55 FR
459M
55 FR
45994
55 FR
45994
55 FR
45994
55 FR
45994
55 FR
45994
FINAL
MAI
PUBLISH
DAK
10-11-90
10-11-90
10-11-90
10-11-90
10-11-90
10-11-90
10-11-90
10-11-90
EFFEC-
TIVE
DATE
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
NOTES
This nil* alto aaandi standard language regarding
the haurd coMunlcatlan progrsa) (11271.21, 271.72).
Polyol carboxylate mttr (generic ran).
Significant UHS effect protection In workplace;
haiard coaiunlcatlon prograa; Industrial. coaMrclal
•nd eoMiMr actlvltlM; dlnoMt.
2-Propmolc acid. 2-hydrnnjhutyl Mtw (CAS No.
2421-27-4). SlgnlflcMit MM urn offoct protKtlm
In tho MorkplK*; haurd coauilcatlon progra*;
Industrial, contrclal and comuMr actlvltlw;
disposal.
2-FTapanolc acid. l-(bydroMyMthyl) propyl ntar.
Significant MM UMS affact protection In norkplaco;
haiard coMunlcatlon prograa; IndMtrlal. coMerclal
and comuMr activities: dlspasal.
••action product of a aonoalkyl succlnlc anhydride
Significant nw usos affect protoctlon In workplace;
hatard coaauilcatlan pragra*; Industrial. coaMrclal
and cansiasir activities.
llspkanal A. eplcklorotrydrln, wtkylansbla
(•ttetltuted carboBBnocycle), palyalkylem glycol«
alkanol. Mthacrylata polyaar (generic).
Significant nw uses affect protection In workplace;
haurd cosjaunlcatlan prograa; Industrial, coaairclal
and consuasr activities.
TrlMtnylolprepane fatty acid dlacrylata (gmtrlc).
Significant new IMS affect protection In workplace;
haiard coaaunicstlon prograa; industrial, coawrclal
and consuaar activities.
Substituted axlds-alkylena polyaar. Mthacrylata
(generic). Significant nw uses affect protection
In workplace; hatard coaaunlcatlon prograa; .
Industrial, comerclal and consuasr activities.
-------
                   CHEMICALS 0        ING RULES (COM) DATABASE



RULE CODE. ODE OF FEDERAL REGULATION    ,. AMD FEDERAL REGISTER 
P-89-73
P-89-77
•-89-422
P-89-423
P-S9-424
P-89-S07
P-89-694
P-89-697
40CFR
CITATION
721.1612
721 .279
721.1818
721.1617
721.767
721.1285
721.290
721.289
PRO-
POSED
RULE
DATE
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
PROPOSED
RULE FOR
CITATION
SS FR
272S7
SS FR
272S7
SS FR
272S7
SS FR
272S7
SS FR
272S7
SS FR
272S7
SS FR
272S7
SS FR
272S7
FINAL
RULE FOR
CITATION
SS FR
45994
SS FR
4S994
SS FR
4S994
SS FR
4S994
SS FR
45994
55 FR
45994
SS FR
45994
SS FR
45994
FINAL
RULE
PUBLISH
DATE
10-31-90
10-31-90
10-31-90
' 10-31-90
10-31-90
10-31-90
10-31-90
10-31-90
EFFEC-
TIVE
DATE
12-31-90
12-31-90
12-31-90
12-31-90
12-31-90
12-31-90
12-31-90
12-31-90
NOTES
1.
PolyMr of alkyl carfacewMcycle dlleocyanate wMi
alkantpolyoi polyacrylatea (generic). Significant
MM UBM affect protection In workplace; haiard
ccwsunleatlon program; Industrial. coaaerclal and
consuaor activities.
AUyldlcarboiyilc acids, polywrt with alkanepalyol
and TDI. alkanol blocked, acrylate (generic).
Significant MM uses affect protection In workplace;
hatard cesautlcatlon program; Industrial. coBMrclal
and comuMT activities.
2-Propmolc acid. 2-avthyl-l.l-dlMthylethyl eater.
Significant ntM IBM affect protection In workplace;
hatard coMunlcatlon progran; Industrial, coaverclal
and consusor activities.
PotyaUylpolysllatane. bla (substituted acrylate)
(generic). Significant net* uses affect protection
In workplace; hatard cooaunlcatlon prograa;
Indtntrial. coanwrclal and consiavr activities.
Carbaalc acid (trlaUyloKysllyalkyl)-substltuted
acrylate eater (generic). Significant MM uses
affect protection In workplace; haiard ceanunlcatlon
prograa; Industrial, ccaverclal and corauaer
activities.
NydroHyalkyl wthacrylate. alkyl eater (generic).
Significant new uses affect protection In workplace;
hazard coMsunlcatlon prograa; Industrial, ceaverclal
and consuser scrlvltles.
Alkeralc acid, trlsubatltuted phenylalkyl
dieubstltuted phenyl eater. Significant new uses
affect protection In workplace; hstard coanuilcitlon
prograa; Industrial, ccanerclal and consunr
activities.
Alkenalc acid, trlaubstltuted beniyl-dlsubstltutcd
phtnyl ester (generic). Significant new uses affect
protection In workplace; hatard coHunlcatlon
prograa; Industrial, ccanerclal and consuser
activities.
                                       25
(10/51/91)
-------
                   CHEMICALS ON REPORTING RULES (COM) DATABASE



RULE CODE. CODE OF FEDERAL KGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
•41
•61
•61
•61
•61
•61
•61
NAME OF RULE OR FH f
P-89-749
P-89-946
P-86-812
P-84-274
P-84-711
P-84-B14
P-85-296
P-85-298
«0 CFR
CITATION
711. 1190
721.759
721.1500
721.1700
721.1715
721.1725
721.278
PRO-
POSED
DATE
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
PROPOSED
RULE FOR
CITATION
95 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
55 FR
27257
FINAL
RULE FOi
CITATION
55 FR
45994
55 FR
45994
55 FR
45994
55 FR
45994
55 FR
45994
55 FR
45994
55 FR
45994
FINAL
RULE
PURLISN
OATI
10-11-90
10-11-90
10-51-90
10-11-90
10-11-90
10-11-90
10-11-90
EFFEC-
TIVE
DATI
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
12-11-90
NOTES

polycaprolactone trlol and alkoxylatad alkanapalyal.
hydroxyalkyl MttacrylM* eater (generic).
Significant INN UM* affect protection In uarkplaces
haurd eoaMilcatlon prograa; Industrial. inaasrrlat
and centum- activities.
Caprolactono, polyaar Mlth huuMthylm
dilMcymU, fcydraiyilkyi wryUta wtir. rMCtlon
product* Mltfc wtatltutcd •Umolc wld md Mtal
(MttroMnDcycU (owwrlc). Significant nw UM«
•ffact protection In Morkplara; haurd coMunlcatlon
prograi; Industrial. coaMrclal and comuatr
aetlvltlaa.
Raactlon product of hydroKyathyl acrylata and Mthyl
mlrana (CAS No. 60057-97-8). Significant nw usn
affact protaetlon In narkplaca; haiard coavnlcatlan
prograa; Industrial. coMMrclal and conauatr
aetlvltlaa: dlwoaal.
Poly2-prapanyOonyl- (CAS No. 52277-SS-S).
Significant nan uaaa affact protaetlon In mrkplacaj
haiard coBMilcatlon profra*; Induitrlal, toaairrlai
and COAMMT aetlvltlaa! dlapaaal.
Alkon/tatad alkana polyot, polyaerylata aatar
(oantrle). Slanlflcant nw UM* affaet pretactlon
In Morkptaca; baiard coafeunlcatlon profraa;
Industrial. coMarclal and conauair actlvltlaat
dlsooaal.
Palyaitetltutad polyal (aanarlc). Significant MM
was affact protaetlon In Norkplaca; Kuard
consuMT aetlvltlaa; dlapoaal.
Aailno acrylata aonoaar (oantrle). Significant nan
uaaa affact protection In workplace; haiard
coaBuilcatlon program; Industrial, casnrelal and
consuMT aetlvltlaa; dlapoaal.
-------
                    CHEMICALS  ON



MILE CODE. CODE OF  FEDERAL REQJ.
ING RULES (CORD) DATABASE



       AND FEDERAL REGISTER (FR) IIIFORNATIOM
RULE
CON
•61
•61
•61
•61
•61
•61
NAME OF RULE OR MM i
•-85-301
P-B5-101S
P-85-1169
P-85-1170
P-86-M6
P-86-554
P-B6-588
40 CFR
CITATION
721.2555
721.271
721.960
721.1740
721.1780
721.1778
PRO-
POSED
RULE
DATE
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
7-2-90
PROPOSED
RULE FOR
CITATION
SS FR
27297
95 FR
27297
59 FR
27297
59 FR
27297
59 FR
272S7
99 FR
27297
FINAL
RULE FOR
CITATION
95 n
49994
99 FR
49994
99 FR
49994
55 fR
45994
55 FR
45994
55 FR
45994
FINAL
RULE
PUBLISH
DATE
10-51-90
10-11-90
10-11-90
10-11-90
10-11-90
10-11-90
EFFEC-
TIVE
DATE
12-11-90
12-11-90
12-11-90
12-91-90
12-11-90
12-11-90
NOiES
I.
Urotham acrylate (generic), significant MM MM
effect protection In mrkplece; hazard coBBuilcatlon
progrca; Industrial, coBMerclal and coMMer
activities; disposal.
Aliphatic dlurethana acrylata actor (generic).
Significant MM MM affect protection In workplace;
hazard ceajsunlcatlon progra*; Industrial, conercUl
and comuBtr activities; disposal.
Acid andlf led acrylated epoxlds (generic).
Significant MM uses affect protection In uorkplace;
haaard casautlcatlen prograsi; industrial, coaanrclal
antf consuaar activities; disposal.
substituted acrylated eUonyiated aliphatic polyol
(generic). Significant MM uses affect protection .
in workplace; hazard ceaBunleatlen prograsi;
Inoustrlsl. ccsMrclal and consuner activities;
disposal.
Poly(oiy-1.2-ethenedlyl), •-[1-oio-2-propenyl)-e-
hydroxy. C,0.1A-alkyl ethers (CAS No. 128504-11-2).
Significant MM MM affect protection In workplace;
hazard coMunlcatlen program; Industrial, comerclal
and consuMr activities; disposal.
Poly(4xy-1.2-ethanedlyl). •-(2-Mthyl-t-oiio-2-
propenyl)-e-hydro)iy-. C|0.,A alkyl ethers.
Significant MM MM affect protection In workplace;
haurd coMunlcatlon prograai; Industrial. coaaercUl
and consuaer actlvltlM; disposal.
                                                                                                                   (10/31/91)
-------
                  CHEMICALS ON REPORTING RULES (COM) DATABASE



RULE 0»E.  CODE OF FEDERAL REOJLATKM (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
•62
•62
•62
•62
•62
•62
•62
•62
NAME W RULE OR PNN i
Significant Mm Uses of Certain
ChoBlcal Substances (SNUR)
P-84-393
2-Cliloro-N-Mtliyl-N-subBtltuted
Acetsalds and Kind Alkylphenol
Foraaldshyds Polyaer. Hotel Salt;
PropMMl Modification of Significant
New Uaa Rulta. Proposed Rule
P-84-491
P-84-860
P-B4-951
P-84-968
P-85-1180
40 CFR
CITATION
721
721.224
771.224
721.261
721.1477
721.979
721.978
721.377
PRO-
POSED
RULE
DATE


5/23/91





RULE FOR
CITATUM


S6FR
23667





FINM.
RULE FOR
CITATION
55 FR
12406
SS FR
32406

» FR
32406
55 FR
32406
55 FR
32406
SSFR
32406
SS FR
32406
FINAL
RULE
PUBLISH
DATE
8-9-90
8-9-90

8-9-90
8-9-90
8-9-90
8-9-90
8-9-90
EFFEC-
TIVE
OATE
10-9-90
10-9-90

10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
NOTES
ThU SNUR Hill reojulre certain persons to notify EPA
•t loMt 90 days before ctownclng •anufacturlng or
proctnlng activities designated by thla SNUR M •
algnlflcant nw UM.
2-Chloro-N-s»thyl-N-substltuted ocetoalds (oenarlc).
Significant nan was affect protoctlon In workplace;
haiard cosjanlcatlon program Industrial. cooMrclal
and cantuaer activities.
EPA Is proposing to codify significant nan use rules
(SNURs) proaulgated under section 5(a)(2) of the
Toxic Substances Control Act (TSCA) for tM ctmfcal
substances faued on receipt of additional data. The
data Indicate that the original tare* of the SNURs
for these substances should be codlf lad.
Substituted aliphatic acid hallde (generic).
Significant nm uses affect protection In workplace;
hazard cessuilcatlon progra*; Industrial. cooMrclal
and consuMr activities: disposal.
Olsubstltutod nltrobantene (generic). Significant
nan uses affect protoctlon In workplace; haiard
ceoBunlcatlon program Industrial, ceawrclal and
comuHr activities; disposal.
Substituted oBlnobentolc acid aster (generic).
Significant nw uses affect protection In workplace;
haiard coBiunlcatlon prograi; Industrial, cosjatrclal
and consuaar activities; disposal.
Alkyl ester (generic). Significant nan uses effect
protoctlon In workplace; haiard coastnlcatlon
prograa; Industrial, conarclal and consuaar
activities; release to water.
tert-Asyl peroxy alkylena aster (generic).
Significant new uses effect protection In workplace;
haiard coaauilcatlon prosraa; Industrial, comaerclal
and consuMr activities; dlspossl; release to water.
-------
                   CHEMICALS ON        NG RULES (CORR) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION     ). AM FEDERAL REOISTER (FR)  INFORMATION
RULE
COM
•62
•62
•62
•62
s62
•62
•62
•62
NAME OF RULE 01 PMN f
P-8S-1S70
P-86-66
P-86-U6
P-86-387
P-B6-1098
P-86-1771
P-87-723
2-Oiloro-ll-Mthyl-N-subatltuted
Acetaailda and Nixed Alkylphenol
Formaldehyde Polymer. Metel Salt;
Proposed Modification of Significant
Hew Use Rules, Proposed *ule
40CFR
CITATION
721.1760
721.2194
721.1763
721.977
721.1478
721.580
721.1272
721.1272
PRO-
POSED
RULE
DATE







5/23/91
PROPOSED
RULE FOR
CITATION







56 FR
23667
FINAL
RULE FOR
CITATION
55 FR
32406
55 FR
32406
55 FN
32406
55 FR
32406
55 FR
32406
55 FR
32406
55 FR
32406

FINAL
RULE
PUBLISH
DATE
8-9-90
8-9-90
8-9-90
8-9-90
8-9-90
8-9-90
8-9-90

EFFEC-
TIVE
DATE
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90

NOTES

polyone (penerlc). Significant MM uses affect
protection In workplace; haiard communication
prcgraa; ndustrlat. commercial and consuaer
activities; disposal; release to Miter.
Substituted trlailne laocyanurate (generic).
Significant MM uses affect protection In workplece;
haiard communication program; Industrial, commercial
and consumer activities; disposal.
Alkyl (heterocycllcyl) phenyleiohetero monocycllc
polyone. ((alkyllmldetolyl) Mthyl) derivative
(generic). Significant MM uses affect protection
In workplace; haiard coeajunlcetlon program;
Industrial, commercial and consuaer activities;
disposal.
Modified acrylic ester (generic), significant MM
use* «ffect protection In workplace; haiard
communication progrea; Industrial, conaerclel and
comuaer activities; disposal.
Halonitrobeniolc acid, substituted (generic).
Significant MM uses affect protection In workplace;
haiard coeaunicatlon program; Industrial, commercial
and consumer activities; disposal.
Mk/lbisoxyalkyl ( substituted- 1.1 -
dlenthylethylphenyl) beniotrleiole (generic).
Significant MM uses affect protection In workplace;
heiard communication program; Industrial, commercial
and consuaer activities.
Netalated alky 1 phenol copolymer (generic).
Significant MM uses affect haiard communication
program; Industrial, commercial and consumer
activities; disposal; releete to wster.
EPA Is proposing to modify significant MW use rules
(SMfte) promulgated under section 5(a)(2) of the
Toxic Substances Control Act (TSCA) for two chemical
substances based on receipt of additional data. The
date indicate that the original tern of the SNURs
for these substances should be modified!
                                        29
(10/31/91)
-------
                  CHEMICALS CM REPORTING MILES (COM) DATABASE



RULE ODE, CODE OF FEDERAL REGULAUM . AW FEDERAL REGISTER (FR)  INFORMATION
RULE
CODE
•62
•62
•62
•62
•62
•62
•62
i
•62
MNE OF RULE OR fm *
P-tt-270
P-8B-4S6
P-88-831
P-8B-837
p-88-2540
P-89-396
P-89-672
P-89-6r6
40 CFR
CITATION
721.1232
72I.21M
721.1536
TZt.lOSO
72M712
721.1S44
721.1632
721.880
PRO-
POSED
RULE
DATE








HUE FOR
CITATION








FINAL
RULE FOR
CITATUM
SS FR
32406
J5FR
32406
SSFR
32406
SS FR
32406
SSFR
32406
SSFR
32406
SSFR
32406
SS FR
32406
FINAL
RULE
PUBLISH
BATE
8-9-90
8-9-90
8-9-W
8-9-90
8-9-90
8-9-90
8-9-90
8-9-90
EFFEC-
TIVE
DATE
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
10-9-90
NOTES
Nltropbanoxvlalkanelc acid ntatltuud thlulno
hydrailda (ganarlc). Significant MM uaaa «ffaet
protactlon In Morkplaca; haiard ceaaunlcatlon
profTM} Indwtrlcl. cowrclat and coroimr
•etlvltlM; dlspaul.
rotyfwtetltutad trlaslnyl) pIpM-uliw (o«wrlc).
Slmlflmit MM IBM affict huard coHuilcstlan
progrv; IndustrUI. coHMrelil ml coruuHr
•etlvltln.
PtMnol,4.4'-(9N-fluor«n-9-ylldH«)blB. Slgnlflcmt
raw IMS affect protactlon In workpl*c«; hai*rd
coBuilcitlon progrMi; Industrial, cotmerciii »ni«
eantuair actlvltlaa.
OlolycloVI athar of dlaubatltutad carbopolycycla
(sanarlc). Significant nra uaaa affact protactlon
In mrkplaca; hazard coaaunlcatlan prasra*;
tnduatrlal. caawrclal and cemuatr actlvltlaa.
Nltrata polyathar patrol (oanarlc). slanlflcant nan
UM* affaet haurd ceaauilcatlon preorao;
Induatrlat. caaawclal and canauan- actlvltlaa.
sutphwbrldajd aubatltutad phanola (oanarlc).
Slsnlf leant nan UM* affaet protactlon In norkplaca:
katard coaauilcatlen preoraai; Induttrlal. cpaairrlai
and conauaH- actlvltlaa.
Alkanolc acid, butanadlet and cyclohaxanaalkanol
palyaaw (ganarlc). Significant nan uaaa affaet
protactlon In mrkplaca; haiard coaautlcatlon
pragrai} Induatrlal. inaaarrlal and corauair
actlvltlaa.
Dlatillataa (patrolaw), CC3-6). polyawa ultb
atyrana and ail>ad tarpanea (ganarlc). Significant
MM uaaa affact protactlon In Morkplaca; haiard
coaauilcatlon prograja; Induatrlal, ceaawrclal and
roniuair actlvltlaa.
-------
                   CHEMICALS 0




RULE CODE. CODE Of FEDERAL REG
IING RULES  (CORR) DATABASE




    ). MB FEDERAL REGISTER (FR> INFORMATION
RULE
CODE
•62
•62
NAME OF RULE OH PM «
P-09-036
P-89-B37
40 CFI
CITATION
721.10U
721.740
PRO-
POSED
RULE
DATE


PROPOSED
RULE FOR
CITATION


FINAL
RULE FOR
CITATION
SS FR
12406
55 FR
32406
FINAL
RULE
PUBLISH
DATE
8-9-90
0-9-90
EFFEC-
TIVE
OATE
10-9-90
10-9-90
MITES
.1
elkyl ether (generic). Significant IMM MM affect
protMtlon In workplace; haiartf cauunlcatlan
prograa; Industrial. coaaarclal and caratmr
•ctlvltlaa.
Phosphorylattd caprolactona alkyloxantttroKino-cycle
and polyatkylcne polyol alkyl ether (generic).
Significant MM wee affect protection In workplace;
hetard coMunlcatlon program; Industrial, coaoerclal
and cenouBer ectlvltlee.
                                        11
                                                                           (10/31/91)
-------
                   CHEMICALS ON REPORTING RULES (COBS) 0»!«B«\I




KILE CODE. CODE OF FEOEML REGULATION (CFR). AND FEDERAL REGISIER (FR) IHfORNAIKM
RULE
COD;
•63
•63
•63
•63
MS
•63
•63
•63
HAME OF RULE OR PNN 0
Significant MM UM Rules of Certain
Cheilcala (SKJR)
P-83-603

P-84-527
P-M-SS7
P-86-1263
P-86-1634
1
P-86-1692
40 CFI
CITATION
721
721. UTS
72t.1475
721.983
72t.9M
721.1611
721.1491
721.467
PtO-
POSfO
MI
OATi








PtUPOSO
RUE FOR
CITATION








FINAL
RULI FON
CITATION
ss n
33296
ss n
33296
SS FR
S227S
SS Ft
33296
SS FR
33296
SS FR
33296
ss n
3S296
SS Ft
31296
FINAL
RULE
PU8LI8N
DATE
8-13-90
$-15-90
»:21-90
8-1S-90
8-15-90
8-15-90
8-15-90
8-15-90
IFFIC-
TIVE
OATI
10-1S-90
10-15-90
12-21-90
10-15-90
10-15-90
10-15-90
*
10-15-90
10-15-90
NDTE8
TkU 8NUR Mill require certain persom to notify
CM ot Itnt 90 days before caoMncIng
•nufwturlng or procMsIm wtlvltlm dnlfmtcd
bt this UM n • •Ignlf IcMtt MM UM.
tutetltukcd nltrll* (Nmtrlc). Olgnlflcwt MM
UM« tffMt protwtlon In tto norkploc*, Iwurd
MMunlcatlon preorw, IndustrUl, ctMtrcUl. and
coMUMr Ktlvltln. «d ralMM to mttr.
Ooctlon 721.U7S(o)(2)(ll> lo MMnoM by
corroctlra tho roforonco "CgM-WI)" to rnd
•(•)C4)(I)."
UMaturotod Mlm olkyl Mtcr ult (MMrIc).
Significant MM MM tfftct pratoctlon In tho
MorkploM. hmrd coMunlcatlon progroB,
Industrial, comrclsl. ond consuHr octlvltlts.
UMsturstod Mlno ssttr sstt (osMflc).
Significant MM usos affoct protoctlon In tho
Morkplaca, hasard ccMUilcatlon progrw,
Industrial, caasirtlal. and COMUHT activities.
Hiespherlc acid. 1.2-ottoMdlyt totrakls(2-cMoro-
1_»»iitui mifcul 1 mmtmf ClfHilflc^nfr «^Mi i^«a mtlmrt
protoctlon In tho Morkploco, haurd caaunlcatlon
activities, and disposal.
OitMtltutod dlalkyl ousoloM (oonsrlc).
Significant MM usos offset protectlen In tho
Morkploco, haiard coBUilcotlon progroB,
Industrial, cnaairrlal, and consustr activities,
	 • ^»m 	 •
flWw QllpOMIo
lemons, substituted alky! acrylete derivative
(generic). Significant MM wee affect protectlen
In tho Msrkplaca, hatard ceoMilcotlon progrea).
Industrial, ceenerclal, and consuMr activities,
end dlspesal .
-------
                   CHEMICALS ON        I** RULES (CORD) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION     I. MB FEDERAL REGISTER  (FR)  INFORMATION
RULE
CODE
•63
•63
•63
•63
•63
•63
•63
•63
•63
NAME Of RULE OR MM •
P-87-90
•-87-794
P-87-1337
P-87-1760
P-88-217
P-88-864
P-88-972
P-88-1460
p-88-1340
40CFR
CITATION
721.1395
721.266
721.967
721.1540
721.1621
721.1537
721.2155
721.821
721.1645
PRO-
POSED
RULE
DATE









PROPOSED
RULE FOR
CITATION

,







FINAL
RULE FOR
CITATION
SS FR
33296
55 FR
33296
55 FR
33296
55 FR
332*6
55 FR
33296
55 FR
33296
55 FR
33296
55 FR
33296
55 FR
33296
FINAL
RULE
PUBLISH
DATE
8-13-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
EFFEC-
TIVE
DATE
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
NOTES
NetPiylmbUtrlaUbatltutod ml lira (gmrlc).
Significant ran MM affect protection In tho -
workplace, haiard cooaunlcatlon progrM,
Industrial. coHaerclal. and fiwiiuaar octlvltloo.
•nd disposal.
Acrylnlda polyacr tilth substituted
•Ikylecrylaojlde Mlt (generic). Significant MM
MM affect Industry, coawrclal. and conauaer
activities.
Dlwlfonlc acid rmln amlm aalt of a benxldlra
derivative (generic). Significant ran MM affect
Industrial, coonerclal, and cerauaer actlvltlea.
Phenol. 4.4'-lo*thylenebU(oiiy2.1-
•tharadlylthlo)|bla- (CAS No. 93589-69-6).
Significant MM use* affect hatard coMunlcatlpn
progress and release to Mater.
Epoaldliod polybutera. Significant ran use*
of fact Industrial, conaerclal. and consuatr
actlvltlaa.
Ptierall4.4'-Mthyl«iebla(2.6-dlMthyl) (CAS No.
5U4-21-4). Significant MM uses affect
protection In tho workplace, haiard covutfcatlon
program. Industrial, coMerclol. and consuner
actlvltlea. and release to nattr.
3.33,S.$«-Tetramethylblphenyl-4.4'-dlol.
Significant raw uses affect protection In tho
workplace, haiard conaunlcatlon program,
industrial, coMnerclal. and consuacr activities,
and disposal.
2,S-Dlaercapto-i.3.4-thladlaiolo, alkyl
polrcarboxyloto (generic). Significant new uses
effect Industrial, coonerclal. and comuaar
actlvltloo.
Polyaer of oaleic anhydride, benienedlcarbojiyl Ic
acid and dlsubstltuted alkylanlra (generic).
Significant new uses affect Industrial.
cunercial, and consuner activities.
                                        33
                                                                                                                 (10/31/91)
-------
                   CHEMICALS ON REPORT IMC RULES (COM) DATABASE



MILE CODC, CODE OF FEDERAL REGULATION (CM). AM) FEDERAL  REGISTER (FR> INFORMATION
RULE
CODE
•61
•63
•61
•63
•63
•63
•63
•63
NAME OF RULE OR PNN ff
P-B8-1616
P-88-1617
P-B8-1753
P-U-18B9
P-B8-2SB2
P-89-483
P-89-S76
P-BO-577
40CFR
CITATION
721.1638
721.2075
721.766
721.1040
721. U95
721.1616
712.1265
732.1265
PRO-
POSED
RULE
DATE








MAE FOR
CITATION








FINAL
RULE FOR
CITATION
55 FR
332*6
SS FR
33296
55 FR
332*6
55 FR
33296
55 FR
332*6
55 FR
33296
55 FR
33296
55 FR
33296
FINAL
RULE
PURLISN
DATE
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
8-15-90
EFFEC-
TIVE
OATE
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
10-15-90
NOTES
Potywr of aubotltutod otkylphenol foraatdahydo
and phthallc anhydride, ocryloto (generic).
Significant INN IMS affect protection In the
Morkplece. twurd coaaunlcatlcn program
Industrial, fiiaoarrlel. end cansunr activities.
Terpones ml t«rpm><4§. UMWW frMtlan.
polyw Mlth Mtetltuttd carbapolycyclt*
(0«wrlc). Significant ntn UMS tlftct
IndntrUI. coMwcUI. and corauMr Ktlvltlat.
8U(«fMtltut«d)carboMnocycllc.
uocMtoMnocyllcol (ganarlc). Significant nm
MM affect hasard coMunlcatlen progra*.
Induatrlal. coHwrcUI. and corauwr actlvltln,
and dlapoaal.
Fatty acid, aailna aalt (ganarlc). Significant nw
mat effect hatard coaaunicatlon prograa,
Induetrlel. coeMrclel. and cemuaar actlvltlee.
and raleaaa to Mater.
2-Onpanona. palywr tilth 4.4«-<1-
Mtkylathylldma) bltphenol and 2.2.- 1(1-
Mtnyletnyl iome)pis(«« l *
Significant nw uaea effect protection In the
Morkploce, haiard coaautlcatlon progroa,
Industrial, nioaiirlai. and censuatr actlvltlea.
Pelyalfcytorapolyol •tkylaajlne (generic).
Significant new uaao of feet protection In the
ft^KM8*K| — — — ikakeie^OMgl dM^a^HMkl«»Afl>l JM» •^ptfMa*a^ai
MOrRpiKVf nvura cvHuiicBiion prfjf§mi|
Induatrlal. ceawrclal. and comuaer actlvltlea.
Metal aalt of cooploii Inorganic oiyacld.
Significant nan uaea affect Induatrlal,
coBMrclal. and comuaer activities.
Netol aalt of cooplex Inorganic oiyacld.
Significant nm IBM affect Induatrlal,
cooBerclal, and conauair actlvltlea.
-------
                   CHEMICALS ON



RULE CODE, CODE Of FEDERAL REOJU,
NG RULES (CORK) DATABASE



   1. AND FEDERAL REGISTER (FR) INFORNMION
RULE
CODE
•63
•65
•63
•63
•6S
•63
•63
NAME OF RULE OR PM ff
P-89-632
Significant Nan Us** of Certain
ChcBlcal Substance* Corrtctlon

Technical Aaindssnt to Slgnlf leant
New UM Rule
P-87-794
Polymer of Nalelc Anhydride.
Bentenedlcarboxyllc Acid end
D I substituted Alkyloalne. Proposed
Revocation of • Significant Men UM
Rule
Polysm- of Nalelc Anhydrlda.
Renienedlcarboxyllc Acid and
Dlsubstltuted Alfcylaalne; Revocation
of a Significant Men UM Rule
P-B8-1S40
Significant Men UM Rule; Correction
P-83-603
40CFR
CITATUM
721.1799
721
721.1616
721.264
721
721. IMS
721. UTS
PRO-
POSED
DATE




2/27/91
2/27/91

PROPOSED
RULE FOR
CITATION




56 FR
sin
S6 FR
am

FINAL
RULE FOR
CITATION
SS FR
33296
SS FR
S227S
SS FR
S227S
SS FR
S2276

S6 FR
43B77
S6FR
29903
FINAL
RULE
PUBLISH
DATE
8-1S-90
12-21-90
12-21-90
12-21-90

9/5/91
7/1/91
EFFEC-
TIVE
DATE
10-15-90
12-21-90
12-21-90
12-21-90

11/4/91
7/1/91
NOTES
t.3-Prapvwdla*lne.M.M'-1.2-ethanedlylbU-poly)Hr
Mlth 2.4.6-trlchloro-1.3.S-trlatlm. reaction ,
product* Mlth N-butyl -2,2.6.6- tetraMthyl-4-
plperldlnasjlne. Significant MM uaea affect
protection In the workplace, hazard ceasjunlcatlon
progran. Induatrlal. coaBsrclal, and coneuaar
activities, and releaae to water.
Correction of tno cross-references uhlch Here
Inadvertently etatod In the August IS. 1990
Federal Register (SS FR 33296).
Section 721.1616(a)(2)(ll) la aa»ndsd by
correcting the reference "(g)( I )(!»)• to reed
"(gMWIJO."
Final Rule; Technical Anenttaent. Document (FR DOC
90-191BS) published In the August IS. 1990 Federal
Reglater (SS FR 33296) Inadvertently assigned |
721.266 to acrylaailde. palyner Mlth substituted
alkylacrylaailde aalt (P-87-794). Thla subatance
la being redes (gnat ad as I 721.264.
EPA la proposing to revoke a SNUR for a chearical
eubatance because of additional toxlclty data
received Indicating that the subatance Mill not
present an unreasonable rlak of Injury to huaan
health.
EPA la revoking the algnlf leant new we rule
(&MJR) et 40 CFR 721.164S.
For substituted nitrite In f 721.1475.
Inadvertently the redeelgnation of | 721.1475 MOB
OBltted fraa FR Doc. 90-19185. Thla document
corrects that omission.
                                                                                                               (10/31/91)
-------
                   CHEMICALS ON REPORTING RULES (COM) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CFR). AMD FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
•64
•64
•64
•64
•64
•64
•64
•64
IMC OF RULE 01 Mi 0
Slgnlf Icint MM Uu of Certain
Chaalcal Substances • Final Rut*
P-83-237
P-83-1162
P-83-1163
P-84-1219'
P-B5-36
P-85-216
P-85-236
40 CFR
CITATION
721
721.1SS8
721. IBM
721.18SS
721.1845
721.184S
721. IDS
721.1845
PRO-
POSED
RULE
DATI
9-28-M
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
RULE FOR
CITATION
55 FR
1OM9
«VQOe>
55 FR
S9882
55 FR
S9882
55 FR
S98S2
55 FR
39882
55 FR
S9882
55 FR
39882
55 FR
39682
FINAL
MULE FOR
CITATION
56 FR
23766
56 FR
2S766
56 FR
2S766
56 FR
2S766
56 FR
2S766
56 FR
23766
56 FR
23766
96 FR
23766
FINAL
RULE
PURLIN
DATE
5-23-91
5-23-91
5-23-91
5-23-91
5-23-91
5-23-91
5-23-91
5-23-91
EFFEC-
TIVE
DATE
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
MOTES
EM hM preauleated this SMUR to require certain
pereons to notify EPA at Itnt 90 days before
ceaaanctng Manufacturing ar prccesttng activity
designated by thla SNUR aa a alonlflcant DM UM.
Raleoanatad alkyl pyrldlm (ganarlc naa»).
Significant nan wee affact protection In tha
uarkplaca. haiard cowunlcatlon prograi. dlipoaal.
and ralaaaa ta inter.
Nalogenatad alkyl pyrldlm (oantrlc naao).
Significant nm waa affect protactlon In tha
uorfcplaca. haiard coiaunlcatlon prograa. dl«pot«l,
and ralaaia to Mattr.
Maloganatod pyrldlna (gamrlc naaa). Significant
nm utta affact protactlon In tha Morkplaca. haiard
ceaaunlcatlon prograa. dlapaial. and release to
uater.
Sutetltuted pyrldlm Coantrle naw). Significant
MM utea affact protection In tha workplace, haiard
ceaaunlcatlon pregraa. dlapoaal, and relaaM ta
Mater.
NuBMltutad pyrldlna (ganarlc naaa). Significant
nan was affect protactlon In the wrkptaca, haiard
coaaunlcatlon prograB. dlapeaal. and ralaaaa ta
wter.
Nalagamtad pyrldlm (generic naaa). Significant
MM wee affact protactlon In the workplace, haiard
ceaaunlcatlon prograa, dlapoaal , and release ta
uater.
Substituted pyrldlm (generic naw). Significant
nan waa affact protection In the wrkptaca. haiard
ceaauilcatlon prograa, disposal, and release ta
wter.
-------
                   CHEMICALS OH       MO MILES (CORK) DATABASE



RULE CODE. CODE Of FEDERAL RE6U~..._     ). AND FEDERAL REGISTER  (FR)  IN'OMUTION
RULE
CODE
•64
•64
•64
•64
•64
•64
•64
•64
•64
•ME Of RULE OR (KM f
P-85-535
P-83-536
p-85-706
P-85-1184
P-86-a38
P-88-1271
P-88-1272
p-88-1273
P-88-1274
40CFR
CITATION
721. ISIS
121.1835
721.1845
721.1845
721.1840
721.1886
721.1886
721.180
721.1880
PRO-
POSED
RULE
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
PROPOSED
RULE FOR
CITATIOH
55 FR
S9882
55 FR
39882 .
55 FR
99882
55 FR
39882
55 FR
VMM
«VQwff
55 FR
39882
55 FR
39882
55 FR
39882
55 FR
39882
FINAL
RULE FOR
CITATION
56 FR
23766
56 FR
23766
56 FR
23766
56 FR
23766
56 FR
23766
56 FR
23766
56 FR
23766
56 FR
23766
56 FR
23766
FINAL
RULE
PUBLISH
DATE
5-23-91
5-23-91
5-23-91
5-23-91
5-23-91
i
5-23-91
5-23-91
5-23-91
5-23-91
EFFEC-
TIVE
DATE
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
7-22-91
NOTES
1
Nalogenated pyrldlM (generic MM). Significant
MM MM affect protection In the Morkpleco, halard
coBuunlcatlon progrM. dlepoMl. and roleMo to
Mter.
Nalogenated pyrldlne (generic MM). Significant
MM uses affect protection In the workplace, hazard
ceanuilcatlon prog-re*, disposal, and roleaae to
water.
Substituted pyrldlne (generic MM). Significant
MM uaea affect protection In the workplace, hazard
coanunlcatlon progrM. disposal, and release to
water.
Subatl tuted pyrldlne (generic MM). Significant
MM uaea affect protection In the workplace, hazard
comunlcatlon progrM. disposal, and release to
Matar.
Helogenated substituted pyrldlne (generic MM).
Significant MM uses affect protection In the
workplace, hazard coMunlcatlon progrM, disposal,
and release to water.
Substituted helogenated pyrldlnol, alkali aalt
(generic MM). Significant new uaea affect
protection In the workplace, hazard coMunlcatlon
progrM. disposal, and release to water.
Subatltuted halogenated pyrldinoi. alkali salt
(generic MM). /Significant new uses affect
protection In the workplace, hazard coanmlutlon
pragrM. disposal, and release to water.
Subatltuted halogenated pyrldlnol (generic MM).
Significant new uses affect protection In the
workplace, hazard ceonunlcatlon progrM. disposal,
and release to water.
DlsU»tltuted halogenated pyrldinoi (generic MM).
Significant new uses affect protection In the
workplace, hazard coanunlcatlon progrM. disposal.
and release to water.
                                       37
                                                                                                               (10/11/91)
-------
                   CHEMICALS ON REPORTING RULES (CORR) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CFR).  AND FEDERAL  REGISTER  (FR)  INFORMATION
RULE
CODE
•65
•65
•65
•65
•65
•AS
•65 '
NAME OF RULE OR PNN •
Significant Nw Uses of Chariest
Substances
P-M-358
P-M-938
P-M-1167
P-85-118
•-8S-41S
P-85-S27
40 CFR
CITATION
721
721.1489
721.1641
721.1887
721.1790
721. US*
721.1005
PRO-
POSED
MILE
OATE






1
MUMMED
RULE FOR
CITATION







FINAL
RULE FOR
CITATION
55 FR
39692
55 FR
59892
SS FR
S^OTC
SS FR
39892
SS FR
39892
i
SS FR
IttKtt
I •wl'MWM
SSFR
1QM9
JTwTC
FINAL
RULE
PU8LISN
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
\.
EFFEC-
TIVE
DATE
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
NOTES
This SNUR Hill require certain persons to notify
EPA at ItMt 90 dsys before coMenctna
Mriufocturlng or processing activity designated by
this SNUR n • etgnlflcant KM UM.
unseturatad orgwilc co^mnd (gwwrlc MM).
Significant MM MM affect prot action In tha
Mrkplaca; haiard coMtnlcatlon progrM;
Induatrlal. coMarclal. and coMuaer actlvltlos;
•nd dlffpowl •
Polywr of hydro«y*thyl acrylata and polyltocyaMta
(gtrarlc MM). Significant nw usta affect
protoctlon In tha workplace; haiard ceaaunlcatlon
progrM; Induatrlal, coMarclal, and corauatr
actlvitlaa: anddlaposal.
(Epony ratln (ganarlc MM). Significant MM MM
ijiffact protect Ion In tha Morkplaca; haiard
^cMJUilcatlon program and Industrial, coMarclal.
and cenauMf activities.
Mlyurttham (gaMrlc MM). Significant MM MM
affact protection In the Mrfcolace; haiard
CMMRlcatlon progrM; Induatrlal, coMerclal, and
tSiniiBMjr actlvltlee: and dlapoaal.
."•
Nonoacrylata (aantrle MM). Significant MM MM
affect protection In tha Morkplace; haiard
•cbaBunlcatlon progrea; Induatrlal, cMMrclal, and
cipniuper actlvltlM; and dlapoaal.
lylnyl tpony otter fgenerlc MM). Significant MM
««M affect protection In the Morkplace; haiard
cMMunlcatlon prograa; Industrial, coMarclal, and
consuMr activltlM; and disposal.
-------
                   CHEMICALS ON       NG RULES (CORD) DATABASE




MILE CODE. CODE OF FEDERAL REGULMliai     ). AND FEDERAL REGISTER (FR)  INIOUMUON
RULE
coot
•65
•69
•65
•65
•6S
•65
•65
•65
MIC OF RULE n PNN f
P-85-544
P-85-54S
P-8S-546
p-85-547
p-as-1034
P-86-164
P-86-334
P-86-335
40CFR
CITATION
721.1828
721.1805
721.1824
721.1816
721.1470
721.1622
721.455
721 .440
PRO-
POSED
RULE
OATE








PROPOSED
RULE rot
CITATI01








FINAL
RULE FOR
CITATION
55 FR
loMn
JVWK
55 FR
WlPWli
55 FR.
59892
55 FR
39892
55 FR
IQUQl
JWFC
55 FR
•MM •
JIWU9m
55 FR
59892
55 FR
39892
FINAL
RULE
PUBLISH
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
1 9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
OATE
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
11-27-90
NOTES
2-Proptnolc acid. 2-a»thyl-.7.7.9-trlMthyl-4.M-
dluxo-3,14-dloxo-5.12-dlozahejiadscone. 1.16-dlyi
eater. Significant INM uses affect protection In
the workplace; hazard cosauilcatlon progrM;
Industrial. conwrcUl. and comiMT •ctlvltl**;
•nd disposal .
2-Propcnolc Kid. 3-(dlMthylHlno)-2.2-dlMthyl-
propyl ntar. Significant neM usm affect
protect Ion In the workplace; hazard coMutlcatlcn
progr**; Industrial, coanerclal. and consunr
activities; and dlspoaal.
2-Proptnolc acid. 2-nethyl-. 3.3.5- trla»thyl
cyclohexyl ester. Significant MM uses affect
protection In the workplace; haiard ceawilcatlon
prograa; Industrial, cooaerclal. and consuscr
activities; and dlspoaal.
2-Propenolc acid. I.S.S-trlacthylcycloheiiyl ester.
Sionlf leant new uses affect protection In the
workplace; hazard coasuntcstlon pragrn;
industrial, cosnerclat. and consuser activities;
and disposal.
Nickel acrylate cocplex (generic nasw).
Significant new uses affect protection In the
wbrkplaco; hazard comunlcation prograii;
Industrial, coawrcial. and consuatr activities;
and disposal.
Potyaer (generic ran*), significant nut use*
affect protection in the workplace; hazard
conaunlcatlon prograa; Industrial, coonerclat, and
consuaer activities: and disposal.
AroflNtle Mine compound (generic nsM).
Significant new uses affect protection In the
workplace; hazard comounlcation prograa;
InAatrlal. conerclal. and consuner activities;
ami disposal.
Aromatic nitre compound (generic name).
Significant new uses affect protection In the
wort pi ace; haiard coonunlcatlon program; and
Industrial, commercial, and consumr activities.
                                       39
(10/31/91)
-------
                   CHEMICALS ON REPORTING MJIE8 (OMR) DATABASE




MILE ODE. CODE OF FEDERAL  REGULATION (CFR). AND FEDERAL REGISTER (FR> INFORMATION
RULE
CODE
•AS
•AS
•AS
•AS
•AS
•AS
•AS
NAME OF RULE OR PNN f
P-8A-ASO
P-8A-1739
P-87-U7
P-B7-7S9
P-88-1898
•-89-AS1
P-89-708
iOCFR
CITATION
721.990
721.564
721.1287
721.1648
721. U90
721.1538
721.1541
PRO-
POSED
RULK
DATE







PROPOSED
RULE FOR
CITATION







FINAL
MILE FOR
CITATION
SSJFR
3Mw£
5$ FR
S9892
SS FR
19892
SS FR
39892
SS FR
19892
SS FR
U692
SS FR
S9892
FINAL
RULE
PUUISH
DATE
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
9-28-90
EFFEC-
TIVE
DATE
11-27-90
11-27-90
11-27-90
9-28-90
11-27-90
11-27-90
11-27-90
NOTE*
Nethacrytlc eater (generic MM). Significant ran
VMS affect protection In the workplace; haiard
coaauilcatlon proarasis Industrial, coaairrisl. and
consular actlvltlea: and disposal.
Substituted bemenedicarboxyllc Kid, polyUlkyl
acrylato) derivative <«tnarle MM). Significant
nw IBM affect protection In the workplace; haiard
coaaunlcatlai program Industrial, comrclal. and
conuaw actlvltlea: anddlwotal.
2-(2-«ydro«y-l-tert-butvl-S-Bethyt«>tniyl)-*-«ethvl-
A-tert-butylphenyl Mthacrylate. Slgnlflcent n««
uaaa affect protection In the workplace; haicd
coaauilcatlon progra»; Industrial, eonmercul. «nd
consuatr ectlvitles; and disposal.
Polyaer of styrena. substituted alkyl
Mthacrylatea. 2-«thylh»«yl ecrylate. Mthacryllc
acid and subatltuted bla(benisns) (generic naae).
Significant nan usaa affect protection In the
Morkplace} haiard coaaunlcatlon program
Industrial. cosMrclal. and comuair activities;
disposal; and release to Mater.
7-Oxablcyclo(4.1.0]naptane.S-etlienyt. hompolyaM-
ether Mlth 2-ethyi-2-(hydroxyMtliyl)-1.S-
prapanadlol (III) apnldlted. Significant MM uses
affect protection In the Horkptace; haiard
cosauilcatlon prairaRi Industrial. coaBsrclsl, and
consuMr activities: and disposal.
PNml. 4.«'-(mybla(2.1-ethansdlylthlo)bls-. (CAS
No. 90884-29-0). Significant MM uses affect
protection In the workplace; haiard cosauiicatlon
proora*; and Industrial, coaaerclal, and coMussr
actlvltlea.
tutfurliad alkylpmnola (generic naae).
Significant new uses affect haiard coaaunlcstlon
prograa; and Industrial, coBBsrclal. and consuatr
actlvltlea.
-------
                   CHEHICALS I        UNO RULES (CORK) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION     •). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
•rllO
•HID
trllO
NAME OF RULE OR PW •
Aral lability of Draft lexicological
Profiles
Tht Revised Priority lift of
••lentous Substances That Will •• tlw
Subject of lexicological Profiles
Idmtlf Icstlon of Priority Dsto Needs
for SB Priority Haiardous Substances
40CFR
CITATION



PRO-
POSED
RULE
DATE

1

PROPOSED
RULE FOR
CI1ATION



FIML
RULE FOR
CITATION
96 FR
92096
96 FR
92166
96 FR
92178
FINAL
RULE
PUBLISH
DATE
10/17/91
10717/91
10/17/91
EFFEC-
TIVE
DATE



ROTES
This nolle* announces tho availability of 2O
updated draft lexicological profiles proparett by
ATSDI for ravleu and coBBant.
CERCLA as asandad by SAM establishes certain
reojulresmta for ATSDR end EPA Mlth regard to
haiardous aubstances which are anst coaaonly found
at facilities on the CERCLA National Priorities
List (HPL). This ratios provides a revleed
priority list of 279 hasardoua subatencas bated on
the spat coaprahentlve InforMtlon currently
available for aubstances found st HPL sites.
This notice announces the Initiation of the ATSDR
Substance-Specific Applied Research Prograai as
•andated by CERCLA by amounting for public
coaannt the priority date needs for 38 heierdaus
substances.
                                        67
(10/31/91)
-------
•66
•66
•66
•66
•66
•66

P-O-1157
P-83-1222
P-63-1227
P-64-492 '
P-66-U92
P-U-522
721.1504
721.1125
721.1032
721.1243
721.1208
721.1235












ss n
46766
ss n
46766
ss n
46766
ss rt
46766
ss n
46766
SS Fl
46766
11-6-90
11*6-90
11-6-90
11-6-90
11-6-90
11-6-90
1-7-91
1-7-91
1-7-91
1-7-91
1-7-91
1-7-91
dHJgnated~i
Substituted oftlroM (generic MM). Significant IWM
uses effect protection In the Morkplace; haiard
coMunlcatlon progroa; and Industrial. ceoMrcial,
and censuser actlvltltt.
Substituted ilkyl Mild, (gomrlc IMM).
llgnlf leant mn MM affoet protection In tha
mrkptaca; haiard coMwilcatlen progrw; and
Induatrlal. coHwrclal. and comuwr actlvltlm.
Porhato alkoxy athar (gamrle IMM). Significant
MM uaaa affect protection In the norkplace; haiard
ceaiunlcatlon pregra*; and InduatrUI, coaaNrclal.
and conaiawr actlvltlea.
SubBtltuted nydratytaBlne (geMric). Significant
MM uaea affect protection In the workplace; haiard
coMunlcatlon program Industrial, ceaairclal. and
eonsuMT activities; and release to Mater.
•Ikyl parav-X-athyt heunoate Cgantrle MM).
Significant MM uses affect protection In the
Morkplace; haurd coBunlcatlon progrea; Industrial.
coMtrclal, and consuajr activities; disposal; and
release to wtter.
NydrailMcarboualds.l.l'-tMthvleMdl -4.1-
Bhenylsns)blsI2.2-dlMthyl- (CM No. 8S09S-61-0).
Significant MM uses affect protection In the
Morkplace; haiard coBsunlcatlon progra*; Industrial.
coMerclal. and consunr activities; and release to
MSter.
-------
              CHEMICALS C       TING RULES (CORK) DATABASE




CODE. CODE OF FEDERAL REGULATION     ). MB FEDERAL REGISTER  (FR)  INFORMATION
RULE
CODE


•rS»




MANE OF RULE « PM *



CoHunlty Rlght-to-KnoM Reporting
RaojulroMnts



40 CM
CITATION


550.
wi.
170. S72


PRO-
POSED
RULE
DATE





PROPOSED
RULE FM
CITATUM






FINAL
RULE FOR
CITATION

55 FR
S06I2



FINAL
RULE
PUBLISH
DATE
7-26-90




EFFEC-
TIVE
DATE

8-27-90




•ores



EPA U praauigatlng final reporting threeholdi
mder Sictlont 111 and 312 at the currant l«««ls.
10.000 pmnd* for non-EHS huardout diMlcaU that
•utt bo roportod. and 500 pomdi or tho TPQ.
whichever U loner for EHSU.
                                   69
                                                                                                            (10/11/91)
-------
                   CHEMICALS ON REPORTINb RULES (COW) DATABASE



MILE CODE. CODE OF FEDERAL REGULATION (CFR).  AND FEDERAl  REGISTER  (FR)  INFORMATION
RULE
CODE
•67
•67
•47
•67
•67
•47
•67
•67 i
i.
•67
NAME OF RULE OR PIN 0
RopropoMl of Significant Mm Urn of
Certoln ChMlcol SuetancM
P-8S-817
P-83-818
P-63-769
P-B3-906 .'
P-B3-908
P-B3-909
p-83-910
P-83-1023
40 CFR
CITATION
721
721.850
721.850
721.660
721.1029
721 .SIS
721.305
721.425
721.1600
PRO*
POSED
RULE
DATE
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
RULE FOR
CITATION
ssn
47286
55 FR
47286
55 FR
47286
55 FR
47286
55 FR
47286
55 FR
47286
SS FR
47286
55 FR
47286
55 FR
47286
FINAL
RULE FOR
CITATION









FINAL
RULE
PUBLI8N
DATE









EFFEC-
TIVE
DAT8









NOTES
TbU prapoeed SNUR Mould rawlra certain ptraom to
notify EPA at ItMt 90 diye before i iiMinrlng any
activity dHlgnatod herein at a olanlf leant MM UM.

{(OlnltroflMnyl laiol - IZl4*dlanm-a-B*tMiyBannmi
MrlvatlvM (generic naM). Significant nw UM*
affact Indwtrlal, coMrclil. and corauair
aetlvltlM.
KOlnltrophanyl )aiol - |2,4-dl««lni»-5-B»tho«yb«utntl
dirlvatlvt* (fttntrlc MM). Significant raw utw
affaet IndustrUI, cwMrclal, and consuMr
actlvltln.
SiM)tltut«d broaathloplMM (gvwrlc MM).
Significant ran MM affect protection In tra
Mrkptaca and hatard caMunlcatlan progrM.
•^^^•^i^*^^ ^^««i •_! fctji Mt^MM t^^^f^^mtft c^^^^ft
arannaiaa aryiaiKyi BUMF tgomric MMBI.
Significant MM MM affaet protection In the
Mrkpleee and hasard CMMunlcatlon progrM.
fthyUt«l MlfNfiMnol (9ftmrtc nata). Slenlflcmt
MM UM« at tact prottctlon In tht norfcplacit and
MBifMriMMMMMkl /MMMM*I« MMMM>% til JRRt t tf 1 r aNliT «MRJ llRUMl
•vxinMyiwjnvi •mvtisn IV •••••§'• •t^llti«»iaTif> VNRBB MM*
affect protwtlon In tfce Mrtplace and haierd
CAV'UnlCeltlOfl Pf^JsTMMV
Anlllm ether ftanarlc MM). Significant MM MM
affaet protection In the workplace and haierd
Phoaphlne( dlalkytplMnyl (generic neat).
Significant MM MM effect protection In the
Morkpleco; haiard coajuilcatlon progrM; dlapoMl;
end relean te Meter.
-------
                   CHEMICALS 01        INC RULES (CORK) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION     ). AND FEDERAL REGISTER 
-------
                   CHENICALS ON REPORTING RULES (COIR) DATABASE



RULE CODE. CODE Of FEDERAL REOULATION (CFR). AND FEDERAL REGISTER (FR)  INFORMATION
RULE
CODE
•67
•67
•47
•67
•67
1
•67
•67
NAME W RULE OR PNN •
P-84-J41
P-84-S42
P-84-3U
P-M-3U
P-84-417
P-84-1042
P-85-703
4ft CFR
CITATION
721.785
721. 28S
721.28$
721.285
721.1*25
721.1175
721.285
PRO-
POSED
RULE
DATE
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
11-9-90
PROPOSED
RULE FOR
CITATION
55 FR
47286
ss n
47286
ss n
47286
55 FR
47286
55 FR
47286
55 n
47286
ss FR
47286
FINAL
RULE FOB
CITATION







FINAL
RULE
PURLIN
DATE

.





EFFEC-
TIVE
DATE







NOTES
2-CxapanaM. naaopolyaer. tittr nit* l-hydraqr2.2-
dlwtHylpraponolc Mid C2i1). dl-2-propenooto. (CAS
No.. 96915-49-0). Significant MM UMS iffwt
protection In MM workplace; Industrial, cooaorclal.
and consuMr activities; Inurd coaauilcetlen
Droaraae end disposal.
2-OjMpenono, hoBDpolyaer, 2-praponoeto, Ctetre-
•>vdro-2-furanyll Mthyt ««ttr. (CAS No. 9691S-50-S).
«nlf font MM IMS affect protection In the
Morkptece; Industrial, t \mmir\ml, and corouMr
actlvltlea; haurd coMuilcatlon pragrM; end

•UMpOnOfW, IIHN|WI yVII , * |H ty«IIU«^»t •»»•! mm
2.2l-[oiybla(Mthylem)bloB-liydraxyMthylJ-1.5-
DroDinedlol. (CAS No. 96915-52-5). Significant nw
MM affect protection In the mrkplm; Industrial.
coHBsrelal. and consuser actlvltl**: livtard
2-Propsnolc acid. |2-|1.1-dlaotliyl-2((1-om-2-
propsnyl) «^«thvll-S-«tliyt-1.S-dloiun-5-vl) aMhyl
actor. (CM No. 87S20-05-6). Significant nan IMS
affect protection In the mrkplace) Industrial.
coaaarclal. and csnuaar activities; haiard
Hetfcytphanal, blafaitetltuted) alkyl (generic naat).
Significant nan IMS affect protection In the
Morkpteco! Industrial. coiBarclal. and conouasr
activities: and heard coBunlcatlon prograo.
Cortaeaodlttilolc acid. Mthyl-. coHpound with
Mtnsneajlne (111). Significant MM ueea affect
protection In the workplace; Industrial, cosBsrclal,
and COMUBST activities; haiard coaaunlcatlon
Pi^OBrflrlff fl"4 41 ffpOvfll o
2-Propanol, 1-aalno-, reaction products tilth
nlaailM. polyMr tilth 5*lsecyonato-1-(lao-
cyonBteaothyD-I.S.S-trlMthylcyclehaMM. 2-hydroiy
ethyl ecrylote-Mocked. Significant MM uaea affect
protection In the workplace; Industrial, cosaairclal,
and consuMr activities; hatard c ntcatlon
prograaj; and disposal.
-------
                   CHEMICALS I
                              i


RULE CODE. CODE OF FEDERAL REI
IT INC RULES (CORR) DATABASE



     :). AND FEDERAL REGISTER (FR) INFORMATION
MILE
CODE
trJU
MANE OF RULE OR PNN f
line tulflde; Denial of Petition
iOCFft
CITATION
STZ
PRO-
POSED
RULE
DATE

PROPOSED
RULE FOR
CITATION

FINAL
RULE FOR
CITATION
55 FR
JIJ42
FINAL
RULE
PUBLISH
DATE
8-1-90
EFFEC-
TIVE
DATE
7-24-90
MITES
OenUI of petition to exempt line wlfldo tr
-------
                   CHEMICALS ON REPORTING RUliS (COM) DATABASE



RULE ODE,. CODE OP FEDERAL REGULATION 
-------
                   CHEMICALS I         UNG RULES  (CORK) DATABASE




RULE CODE. CODE OF FEDERAL REi	    I. ARO FEDERAL REGISTER (FR) INFORMATION
RULE
CODE



•rSIS








NAME OF RULE OR PMN i




Barlua Sulfate; Toxic Chearittl
Release Reporting; Ceamuilty Right-
To-KnoM. Withdrawal of Proposed
Rule.





40 CFR
CITATION



S72.6S


,





PRO-
POSED
MILE
DATE

2-12-90








PROPOSED
RULE FOR
CITATION


n Ft
4B79







FINAL
RULE FOR
CITATION











FINAL
RULE
PO-
LISH
DATE





*



EFFEC-
TIVE
DATE











VOTES




EPA U Nlthdrattlng Its propoMd nil* granting two
petitions to exegpt barlui eulfata fro* tho
rtportlng requirement a wrier the category "bar tin
ceMpounds" of the list of toxic cheat call under
section SIS of the Energency Planning and CoMmnlty
Rlght-te-KnoM Act of 1986 (EPCRA). The Mlthdraual
of the proposal la baaed on EPA*a revleM of the
availability of barlua Ion fro* barlua sutfate anJ
the potential for bar 1 in Ion to Induce toxlclty.
                                                                                                                  (10/31/91)
-------
                   CHEMICALS ON REPORTING RULES (COW) DATABASE



•WE CODE, CODE OF FEDERAL REGULATION (CFR), AMD FEDERAL REGISTER 
-------
                   CHEMICALS I        IT ING RULES (COIR) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION     ). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE



•rSIS














NAME OF RULE OR PNN •




Sulfurle Acid; Tonic Chemical Release
Reporting; Coejuilty Ilght-To-Kimi













40 CFR
CITATION



172.65














MO-
POSED
MILE
DATE

7/24/91














PROPOSED
RULE FOR
CITATUM


96 FR
14156













FINAL
RULE FOR
CITATION

















FINAL
RULE
PUB-
LISH
DATE















EFFEC-
TIVE
DATE

















KOTES




EPA U grafting • petition to Modify tho lUttng
for tulfurlc acid on tho Hit of toxic chesricale
•ubjoct to section 111 of tho Emergency Planning
•nd Conunlty Rlght-to-Know Act of 1986 (EPCRA).
Specifically, EPA U proposing to delete noneerosol
fora* of Milfurlc acid fro* the Mat of tonic
chealcale subject to section 111. The proposal to
delete non-aerosol fora* of sulfurlc acid Is based
on EPA's review of the available data on health and
eavlronaental effects of sulfurlc acid. EPA has
concluded that these fones of sulfurlc acid cannot
reasonably be anticipated to cause adverse effects
to huoen health or the environment under normal
exposure scenarios. Written consents Bust be
submitted on or before Septenfcer Z«| 1991.
                                                                                                                  (10/11/91)
-------
                   CHEMICALS ON REPORTING RULES (COM) 0*"MM



RULE CODE.  r/«f OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (M)
RULE
CODE
•71
•71
•71
•71
•71
•71
•ME OF RULE OR PNN •
Significant Ned UM« of Certain
Chcerical SiAatancoa (SNUR); Final
Rule
•-84-1167
P-8S-71B
•-86- 10U
•-88-1211
P-88-U90
40 CFR
CITATION
721
721.956
721.1028
721.1237
721.1702
721. UU
PRO-
POSED
RULE
DATE






PRUPOKO
RULE FOR
CITATIOi






FINAL
RULE KM
CITATION
56 FR
19228
MFR
19228
S6FR
19228
56 FR
19228
$6fR
19228
56 FR
19228
FINAL
RULE
PUBLISH
BATE
4-2S-91
4-25-91
4-25-91
4-25-91
4-25-91
4-25-91
EFFEC-
TIVE
BATE
6-24-91
6-24-91
6-24-91
6-24-91
6-24-91
6-24-91
NOTES
Thlo SNUR require* certain ptrtam to tuiify EPA at
lent 90 daya before caaaanclnj any aanufacturlng or
procenlng activity dnlgnatad by this SNUR n a
•Ignlflcant ran uae.
EiCHtltutad bla(hydracyalkant) pely«r tilth
aplchlorohydrln. acrylata (atntrlc). Significant
nan MM arai protection In the wrkploce; haiard
coBJUilcatlon progra*; and Induatrlal. ceawrclal.
and corauMr actlvltlaa.
Ol(alkampolyol) ether, polyacrylote (gemrlc).
Significant MM met are: protection In the
Morkplace; haiard coaaunlcatlon progriei; and
Industrial. coMtrclat. and concuatr actlvltlea.
Sitetltutod hydronyalkyl •Ucnoate. [f(II(1-ou-2-
pnptafl >o«yl •IfcMylearbonyaBlnal ntet 1 tutadl
•rat protection In the workplace; liaiard
coaaunfcatlon prograa; and Induatrlal. coaairrlal.
and conwnr ectlvltlea.
Poly(oiy- 1 ,2-athanadlyl }«••• -hydro* . e. -hydroiyi •,
ether tilth 2-ethyL-2-(hydVo>nwthyl>-1,S-pra|NnMtlel
Oil) dl-2-prapanooto. Mthyl other (CAS No. 106158-
22-9). Significant nw im« arei protection In the
Morkploce; haiard coaaunlcatlon progrei; and
Induatrlal. coMrclal. and cemtavr activities.
NonoMthoxy neopontyl (lycol propnylata
•onoecrylate (gemrlc). Significant mw UMO are:
protection In the workplace; haiard coMunlcatlon
prograa; and Induatrlal, ceaatrcial, and comaer
actlvltlea.
-------
                   CHENICALS



RULE CODE. CODE OF FEDERAL
MUG RULES (CORK) DATABASE




     ). ADO FEDERAL REGISTER (FR) INFORMATION
RULE
CODE



•r3»








NAME OF RULE OR PHI «




•otic* Regarding NevUlem to Ionic
Choalcal ReltMO Inventory Rtportlng
Form under Section 311 of tho
Eo»rgency Planning and Coaaunlty
Right-to MOM Act of 1986




40 CFR
CITATION



372








PRO-
POSED
RULE
DATE










PROPOSED
RULE FOR
CITATION











FINAL
RULE FOR
CITATION


S6FR
4879$







FINAL
RULE
PUB-
LISH
DATE
9/26/91








EFFEC-
TIVE
DATE


11/30/91








MOTES




Ihla notlco Infonaa tho public of EPA'a
adalnlatcrlng of tho data aanagoMnt aipocta of the
Toxic Release Inventory (TRI) program. First.
Interested parties are given notlco that the Agency
oust receive voliaitary revisions to Tonic Cheailcal
Release Inventory Reporting Fonat (Fora R or
report) fro* facilities on or before Noveofcer 30th.
In order for the revisions to be Included In the
Initial annual release of TRI.
                                        79
                                                                                                                  (10/31/91)
-------
                   CHEMICALS ON REPORTING MILES (COM) DATABASE



RULE CODE, CODE Of FEDERAL REGULATION ta-hydro-*-(axlrenyl-
e»thoay>-.ether Mlth 2-othyl-2-(hydrmya»thyt)-1.S-
propaMdlel Oil) (CAS He. 52495-71-S). Significant
MM uses arei protection In the workplace; haiard
coBBunlcation program; Induatrlal. coMiorclal. end
coMuser activities: dlwoMli and release to water.
AlkyloMbla (substituted carboBonocycle),
oplchlorohydrln. dlaubetltuted heteromocycle.
acrylate polywr (generic). Significant MM usea
erei protection In the workplace; haiard
caaaunlcatlon prograa; and Industrial, caaverclal,
and consuaer aetlvltlaa.
Ojiyalkantpolyol potyacryiato (generic). Significant
MM usea arei protection In the workplace; haiard
cosaunlcstlon prograaj and Industrial, caoasrclal,
and consuasr activities.
Reaction product of alkyl carboxyllc acids, alfcane
polyolo, olkyl acrylete, and Isophorone dllsocyenete
(generic). Significant MM uses are: protection In
the workplace; haiard ceojunlcatlon prograo; and
Induatrlal. nasMiilsl. end censuser activities.
NethaM. broMdlfluoro- (CAS No. 1511-62-2).
Significant MM uses arei haiard ceaaunlcatlon
proaran; and Industrial, coeaerclal, and consuaer
actlvltlea.
-------
                   CHEMICALS 0




RULE CODE, CODE Of FEDERAL REG
TING RULES (CORR) OAIABASE




     >.  AND FEDERAL REGISTER   I«FORMATION
RULE
CODE
tu
NAME OF RULE OR MM f
••opening of Cosuent Pwlod For
Proposed Test tulM; Off Ico of
Drinking Water Oiearicatst
Cyclohexane,* I.A-Hexaaethylene
Dllaecyanata; and N-MthylpyrroUdone
40 CM
CI1AUOM
799
PRO-
POSED
MM
DATE
M5-91
PROPOSED
RULE FOR
CITATION
M FR
J2292
FINAL
RULE FOR
CITATION

FINAL
RULE
PUBLISH
DATE

EFFEC-
TIVE
OAK

(KITES
EPA is reopening the consent period for the
proposed test rulea on cyeloheKene for 60 day* to
perait further cement on the findings Mode for
ihe» che*tc«ls wider TSCA atctlon 4(«)<1)(B>(I).
In tfaht of the proposed policy articulated
elsewhere In today's Federal Register for oak Ing
legal findings under TSCA section ((a)<1)(B)(l).
Submit written cement* on or before Septeatwr 13,
1991.
                                        81
                                                                                                                  (10/31/91)
-------
                  CHEMICALS ON REPORTING MJLEI (COM) DATABASE



RULE CODE, CODE Of FEKUL REGULATION (CM). MB FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
•71
•71
•71
•71
•71
•71
•71
NAME OF RULE OR PNN •
P-90-584
P-90-584
P-90-641
P-90-667
P-90-668
P-90-1265
P-90-1593
40CFR
CITATION
721.756
721.756
721.1497
721.1064
721.1798
721.1832
721.1797
PRO-
POSED
RULE
DATE







RULE FOR
CITATION







FINAL
RULE rot
CITATION
56 rt
19228
56 FR
29902
56 FR
19228
56 FR
19228
56 n
19228
56 FR
19228
56 FR
19228
FINAL
RULE
PUBLISH
DATE
4-25-91
7-1-91
4-25-91
4-25-91
4-25-91
4-25-91
4-25-91
EFFEC-
TIVE
DATE
6-24-91
7-1-91
6-24-91
6-24-91
6-24-91
6-24-91
6-24-91
NOTES
E-caproloctona tocHfled 2-bydrexyethyl acryloto
tonoaar (ganarlc). Significant nw uaoo oroi
protactlon In the uerkploce; huard cooounlcatlon
pregraaj| and Induatrlotf coojaarclolf ond conwajer
actlvltlao.
EM It laaulng Milt docuoant to comet certain
paragraph cltotlona and creoa-roforenao that NOTO
Inadvertently Incorrect In aoverol Federal Regleter
•loolhyletod tatty olkyt m\m wide (generic).
Significant nw uao lai reloaM to water.
Fomaldehyda. polyw tilth (chloroMthyl)
nlrana.4.4*-(1-aothyl othylldene) bla!2.6-
-*•• 	 * 	 -* • ««J ^^^^IA| 9 	 ~. 	 . 4 MM^M^^^kAAA A
aiDrooopnanaii ana pnonoi, c-ootnyi-«*propanaaio.
Significant nw UBOB oroi protection In the
Morkptecoj beurd covjuilcotlen progroojf end
IndUBtrlol. coaoorclol. and rnntTT octlvltleo.
2-Propananltrllet polyow Mltfc I.S-kutodlana. 1-
Hlth oplchlorohydrtn, forwIoMiyrio. 4.4'-(1-
— .gjfc. J •*•.. |j 8 ^•••%gkiMl'*> ^- Jlfc—— — Jw— ^-^.1 • ^m^ ^Nk^Bk«hl
•Wunrtvuiyi iijaWiiifoviiiiN»|O^iDraRwpnOTBij w invnvii
2*g»ttiYt-l-prop.»ioit». SI0nlf leant nm IBM am
protection In tha wortolacai baurd MMnlcatlan
prograBB ond Induatrlolg coflairclolf ond conauoar
octlvltleo.
2-Prepenalc ocld, o%tolia>o-4l7-a*thano-1N-lndonyl
otter (CM No. 79fl7-n-4). Significant nw UHO
arei protection In the wrfcplocoi hourd
caBMunlcotlon progroB; Induatrlal, coajaarclol, and
2-Propenonltrlle, polywr with 1,5-butodlone. 1-
corbM^I-cyono-1-Htnylpropyt-terailnated. polyaaro
tilth bltphonot A. opldilorohydrln and 4,4'-(1-
ootnylotnylldeM) bfa[2t6-dlbrooaphenol]t
dloethecrylete. significant nw uaoa arei
protection In the mrkploce; haiard ceaauilcotlon
progro^ and Induatrlol. coaavrclol. and consuvr
octlvltleo.
-------
                   CHEMICALS «|        ING RULES (CORK) DATABASE




MILE CODE. CODE OF FEDERAL REGULATION     ). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
«1
NAME Of RULE OR Ml •
Reopening of Consent Period For
Proposed Teat Rule*; Off In of
Drinking Water ChoBlcals:
Cyclohexono; 1.6-NojuMthylant
OIlMcyarato; and N-Mthylpyrrolldono
40CFR
CITATION
799
PRO-
POSED
RULE
DATE
7-H-91
PROPOSED
RULE FOR
CITATION
56 FR
SZ292
FINAL
RULE FOR
CITATION

FINAL
RULE
PUBLISH
DATE

EFFEC-
TIVE
DATE

NOTES
EPA !s reopening the conent period for the
propose*, test rules on N-Mthylpyrrolldons for 60
days to lemlt further cosBsnt on the findings
•cde for this chariest under TSCA section
4(s)(1)(B)(t). In light of the proposed policy
articulated elseMhere In today's Federal Register
for nsklng legal findings under TSCA section
4(a)(1KB)(l). Subslt Mrltton cosBMits on or
before September IS. T991.
                                                                                                                  (10/11/91)
-------
                   CHEMICALS ON REPORTING RULES (CORK) DATABASE



MILE CODE, CODE 01  rEDEBAL REGULATION (CFR). AND FEDERAL REGISTER (FR> INFORMATION
RULE
CODE
•73
•n
•ra
•73
•73
•73
NAME OF RULE OR CNN •
Significant MM UM* of Certain
Che»lcal Substances. Final Rut*
P-8B-894
P-M-13M
P-90-1357
P-90-1569
I
P-90-U2
40 CFR
CITATION
721
72t.4M
721.490
721.1100
721.1105
721.1140
PRO*
POSED
RULE
DATE






RULI FOR
CITATION






FINAL
RULE FOR
CITATION
96 FR
40204
96 Ft
40204
96 FR
40204
96 FR
40201
56 FR
40204
96 FR
40204
FINAL
RULE
PUBLISH
DATE
8/13/91
•/13/V1
8/13/91
8/13/91
8/13/91
8/13/91
EFFEC-
TIVE
DATI
10/19/91

10/19/91
10/19/91
10/19/91
10/19/91
NOTES
EM requires certain persona Mho Inland to
aanufacture. laport, or process these substances
for a alonlf leant new UM to ratify EM at least
90 days before cmannrlng the Manufacturing or
processing of the substance for a use drslgnsted
bv this SNUR as a significant MM use.
The chealcal subatanco Identified as beniene, (1-
Mthytethyl) (2-phenyUthyl)-. (CAS No. 77851-17-
3) la subject to reporting undw this section for
the significant nan uses The significant IHH uuo
am Protection In the workpteco. Netsrd
coesuilcstlon pregrssi. Industrial. cawercUI.
and consuMT activities. Disposal.
The enterics! substance Idmtlfled as
benienedlesonluB. 4-(dlMthylaalno)-, salt Mlth 2-
hydroxy-9-sulfobmole acid (CAS No. 124737-31-1)
Is subject to reporting under this section for the
significant ran uses. Protection In the
workplace. Naurd coajuntcatlon prograa.
Industrial, coajsarclal and consuasr activities.
Release to Hater.
UM choaJcal substance Idantlflod eenerlcally as
glycel oonobsnioete la subject to reporting undir
thla section far the algnlf leant nau mas. Nsssrd
coajunlcatlon prograa. Industrial. coaMrclal.
and consuasr activities.
The chejilcal substance Identified as glycola.
tetrsMthy! butyDphenvt ether, sodlua salt Is
subject to reporting under thla section for the
algnlf leant nan uses. Natsrd coaaunlcstlon
prograa. Industrial, eoaaorclal, and consuasr
activities.
The choBtcal substance Identified gsnerlcally as
trlsCdlsubstltuted alkyl) heterocycle Is subject
to reporting undrr thla section for the
significant new uses. Protection In the
Horkpleco. Raiard coajsunlcatlon prograa.
Industrial. coHHorclsl. and consuair activities.
-------
                   CHEMICALS (       TING RULES (CORK) DATABASE




RULE CODE. CODE OF FEDERAL REI	     ). MB FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
t»
tSS
tSS
tss
tSS
tSS
tss
tSS
tSS
tSS
tSS
tSS
tSS
tSS
MIC OF RULE M HOI *
Conditional Exemptions fro» TSCA
faction 4 TMt Rulas













40 CFR
CITATION
790.80
799.2179
799.21SS
799.21SS
799.16SO
799.2S2S
799.12SO
799.2700
799.2475
799.1051
799. 10SS
799.4400
799.4340
799.3300
PRO-
POSED
MILE
DATE














PROPOSED
RULE FOB
CITATION














FINAL
RULE FOR
CITATION
SS FN
50879
55 FR
50679
55 FR
50879
SS FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
55 FR
50879
FINAL
RULE
PUBLISH
DATE
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
EFFEC-
TIVE
DATE
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
12/11/90
NOTES
Notice: EPA U granting conditional exemptions fro*
TSCA Section 4 teat rule requlresNnts to certain
Manufacturer* of chealcala substances subject to
theae rule*.
-
C9 aroBBtlc hydrocarbon fraction (CAS Ho. 70693-06-
0)
Nethylcyclopentane (CAS No. 96-37-7)
n-Hexana (CAS No. 110-54-3)
2-Ethylhexanolc acid (CAS No. 149-57.-S)
Isopropanol (CAS No. 67-63-0)
Heta-cresolt (CAS No. 108-39-4)
Methyl ethyl ketoxlne (CAS No. 96-29-7)
2-flercaptobeniothlazole (CAS No. 149-30-4)
NOTocMorobeniene (CAS No. 108-90-7)
1.2.4-Trlchlorobenzene (CAS No. 120-82-1)
1,1.1-Trichloroethane (CAS No. 71-55-6)
Tributyl phosphate (CAS No. 126-73-8)
n-Phenylenedlanine (CAS, No. 108-45-2)
                                                                                                                  (10/31/91)
-------
                  CHEMICALS H REPORTIHO RULES (COM) DATAMSE



MAE CODE. CODE Of KDEML REOULATION (CFR). MB FEDERAL  REGISTER (FR) INFORMATION
RULE
CODE
•72
•72
•72
•72
•72
•72
•72
•72
•72
•72
•72
I
•72
•72
NAME Of RULE OR MN f
P-84-181
P-84-182
P-84-18!
P-M-1M
P-84-141
P-84-142
P-84-S4I
P-84-I44 '
P-84-417
P-84-1042
P-8S-70S
P-M-O
P-B6-542
40CFR
CITATION
721.285
721.285
721.285
721.285
721.285
721.285
721.285
721.285
721.1425
721.1175
721.285
721.460
721.1025
PROPOSED
RULE DATE
1-27-85
S-27-85
5-27-85
S-27-85
4-4-86
4-4-86
4-4-86
4-4-86
1-21-85
1-24-86
6-21-86
7-24-86
1-25-87
RULE FOR
CITATION
son
12046
50 FR
12046
50 FR
12046
51 FR
11591
51 FR
11591
51 FR
11591
51 FR
11591
51 F8
11591
50 FR
11191
51 F8
10027
51 F8
22811
S2F8
26557
52 FR
26557
FINAL
RULE FOR
CITATION
56 FR
56 FR
56 FR
56JR
56 FR
25986
56 FR
48U16U.
29TDD
56 FR
56 FR
25986
56 FR
25986
56 F8
25986
56 FR
9KN5AA
•wTCB
56 FR
25986
56 FR
25986
FINAL
RULE
PUM.ISR
DATE
6-5-91 1
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
6-5-91
EFFEC-
TIVE
DATE
a-sta
8-5-91
8-5-91
'8-5-91
8-5-91
8-5-91
8-5-91
8-5-91
8-5-91
8-5-91
8-5-91
8-5-91
8-5-91
NOTES
Ttw propoMd CIR cltt Ins BMI radnlgrattd.
The propoMd CFR clta hn bMn radMlgMttd.
TIM propond CFR clu hM bMn radnlomtcd.
Tto propoMd CFR elu IIM bMn rtdnlgmtad.
Tbt propM«d CFR cite hM M«I rcdNlgiwtcd
TM proposed CFR cltt hw bMn rtdetlgrated.
TM propoMd CFR cite hM bMn rMMlgratad.
Hw prapMid CFR eltt hM bMn rMMlgratcd.
Tb» prapMrt CFR elt« hM bMn rMMlgMtcd.
Tb* prepM«d CFR clu bn bMn rMMlgratwI.
TMJ PTQMJMQ CFR clt6 bM bMn rMvslOMtMl*
The prapMCd CFR elti KM bMn radMlgmMd.
The propMMl CFR clu hM bMn rMMlgmUd.
-------
                   CHEMICALS        RUNG RULES (CORR) DATABASE




RULE CODE. CODE OF FEDERAL RE       I     '». AMD FEDERAL  REGISTER (FR)  INFORMATION
Mill
COM
ISA
tSA
tu
tM
tSA
tSA
tSA
tSA
ISA
tSA
tSA
ISA
tSA
MIC OF RULE 01 fm 9
Multi-substance Ttttlng for
Developmental and Reproductive
fmlclty and Neurotoxlclty





.






40CFR
CITATION
799.5050
799.5050
799.9050
799.5050
799.5050
799.5050
799.5050
799.5050
799.5050
799.5050
799.5050
799.5050
799.5050
PRO-
FUSED
MILE
DATE
3-4-91
1-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
PROPOSED
RULE FOR
CITATION
5AFR
9092
5A FR
9092
5A FR
9092
56 FR
9092
SA n
9092
5A Fl
9092
SA FR
9092
5A Fl
9092
SA Fl
9092
SA Fl
9092
SA FR
9092
SA Fl
9092
SA Fl
9092
FINAL
RULE FOR
CITATION













FINAL
RULE
PUB-
LISH
DATE













EFFEC
-TIVE
DATE













NOTES
EPA <• proposing • test nils infer TSCA Section 4 fo
obtain developmental and/or reproductive toxtclty data
for the 12 substances designated In this rule.
Acrylonltrlle (CAS No. 107-13-1)
p-Aalnophenol (CAS No. 123-30-8)
BranchloroMtham (CAS No. 74-97-5)
Carbon dltulf Ida (CAS No. 75-15-0)
Dodecylphenol (CAS No. 27193-86-8)
2-EthylheMtnol (CAS No. 104-7A-7)
Hexedecenolc acid (CAS No. 57-10-3)
o-Nydroxyphanol (CAS No. 120-80-9)
2-Nethylpropanolc acid (CAS Ho. 79-31-2)
Methyl ester octenolc acid (CAS No. 111-11-5)
Terephthallc acid (CASi No. 100-21-0)
2.4-To'.uenedle*lne (CAS No. 95-80-7)
                                        87
(10/31/91)
-------
                  CHEMICALS M REPORTING RULES (COM) p«i«B»M



RULE CODE,  CODE Of FEDERAL REOILATIOM .  AND FEDERAL REGISTER (FR) INIORNAIUM
RULf
CODF
•73
•73
•71
•71
•71
•71
NAME OF RULE flt PM §
P-91-11
P-86-1602
P-88-0083
P-91-100
P-90-0226
P-87-1S5S
40 CFR
CITATION
721.164S
721,1796
721.1896
721.189*
721.2184
721.2198
PRO-
POSED
RULE
DATE






PROPOSED
RULE rat
CITATIOi






FIML
HUE FM
CITATION
96FN
40204
96 FR
40204
56 F8
40204
96 ra
40204
56 FN
40204
96 f 8
40204
FINAL
RULE
PU8LIM
DATE
8/13/91
8/13/91
8/13/91
8/13/91
8/13/91
8/13/91
EFFEC-
TIVE
DATE
10/15/91
10/19/91
10/19/91
10/15/91
10/15/91
10/15/91
NOTES
TIM choBlcel eubotenco Idmtlflod eemrlcelly n
polMor of leophorone dlloocyenote,
trleothylolpropem. polyolkylonepolyol,
dleubetltutod olkeneo ond hydmyothyl ecryloto U
eubjoct to reporting unaer this Hctlon for tho
•Ignlflcont ROM UMO. Protottlon In tho
NorkpUco. Hourd conRunlcatlon erogrM.
Induotrlol. Momrclol. ond conoiMr octlvltloo.
Tho choBlcol oitetonco Idmtlflod oo 2-
proponoBld*. N-rS-dlHthyloolmlprapyl)-(PI« P-86-
1602) to «*Joct to roportlng undtr thlo Mctlon
for tho •Ignlflcont MM wot. Protection In tho
Morkploco. Noiord ccoMmlcotlan progrM.
IndMtrlol. caoMrclol, ond corauwr octlvltloo.
Rolono to Motor.
Tho diMleol oitetonco Idmtlflod goiwrlcolly oo
blo(2,2.6.6-totroMthyl pIpM-ldlnyl) o»tor of
cyclaolkyl oplrokotol to oubjoct to reporting
undtr thlo section for tho •Ignlflcont MM UNO.
Protection In the workploco. Noiord nowlcotlan
progroB* Induitrlol, coHwrclol( end connowr
oetlvltleo.
Tho dMRrfral ntMtMct Identified M en o-olofln
•ulfonoto. poteulUR nil lo subject to roportlng
undtr thlo ooctlen for the tlgnlflcont MM UMO.
Roloooo to Motor.
Tho cheolcel oubotenco Idmtlflod oo tltenoto
^1^3(2-)!. dlpotoooluo (CM No. 12056-51-8) lo
•abject to reporting undtr this section for tho
•Ignlflcont MM UNO. Noiord cemnlcotlon
progrei. Induotrlol, coMtrclot, end cannier
octlvltloo.
The cheilcol oubotmco Idmtlflod gemrlcolly n •
•ubotltuted trlphenyleothem U oubjoct to
reporting under thlo ooctlan for tho olgnlflcont
MM MM. Indwtrlol, ceoMrclol, end consuetr
octlvltloa.
-------
                   CHEMICALS 0        I|Mr RULES (CORR) DATABASE




MULE ODE. CODE OF FEDERAL REGUlAriON .   t. AND FEDERAL REGISTER (FR)  INfOMAUON
MILE
CODE


tse










NAME OF MILE OR PM •



Technical Aannifainta to Tot Rule*
•nd Conaont Order*. Mntl Rulo.









40CFR
CITATION


ro










MO-
POSED
MILE
DATE











PROPOSED
MILE F«
CITATION












FIHAL
MILE FOR
CITATIW

M n
23228









FINAL
RULE
PUBLISH
DATE
9/21/91










EFFEC-
TIVE
DATE

5/21/91










NOTES



PurtUMit to 40 CFR 7V0.55 ml T90.M, EPA hte
approved by letter ctrtaln HdlflcatlonB to tMt
atandarda and achedula* for choalcal tMt Ing
prograw inter section 4 of tho Tonic Sitetancea
Control Act (TSCA). Because tlmo Mdlflcatlona
do not significantly alter the scope of o teat or
significantly change the schedule for Ita
completion, EPA approved these requests without
seeking notice and consent. EPA Issued on
Interl* final rule published In the federal
Register of September 1. 1989 (54 FR 56311).
                                       89
(10/31/91)
-------
                  CHEMICALS ON REPORTING RULES (COM) DATABASE



MILE CUE.  CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER 
-------
                   CHEMICALS (        IING RULES (CORK) DATABASE




RULE CODE. CODE OF FEDERAL REGUlimON     . AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE


tS9






NAME OF MILE OR PMN «



BraslMtcd Msn Retsrdsnts (group
I); Proposed Rule; Extension of
Public CoBJssnt Ported




40 CFR
CITATION


795,790,
799





PRO-
POSED
RULE
DATE
9-3-91






PROPOSED
RULE FOR
CITATION

M FR
4SS74





FINAL
RULE FOR
CITATION








FINAL
RULE
PUBLISH
DATE







EFFEC-
TIVE
DATE








NOTES



EPA Is extending the written consent period for
the braerineted fleae reterdsnts (group 1) proposed
rule published In the Federal Register on June 25,
1991. EPA Is slso announcing • public Meeting to
discuss the proposed rule to be held on Noveafcer
20, 1991. Written caeaents should be submitted on
or bsfore October 10, 1991.
                                        91
                                                                                                                  (10/11/91)
-------
                   CHEMICALS ON REPORTING RULES (OKI) DATABASE



RULE CODE.  CODE Of FEDERAL REGULATION CCFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
•rllO
•rllO
srllO
NAME OF RULE OR PNN 9
Availability of Ftml Toxlcological
Prof lias
Intont To Rovlto tht Priority LUt of
Hazardous subatancoa That Will la the
Subjaet of Taxlcologlcal Proflloa.
Rtqunt far Public Caaaajnt do tho
RavUod Methodology for fianaratlna tho
Priority Llat of Hazardous Subatanctt.
Availability of Draft Toxlcologleal
Prof 1 la for Fluor life*
«0 CFR
CITATION



PRO*
POSED
RULE
DATE

•727/91
9/12/91
RULE FOR
CITATION

UFR
29485
54 FR
44436
FINAL
RULE FOR
CITATION
UFR
29308


FINAL
RULE
PUSLISN
DATE
6724/91
•

EFFEC-
TIVE
DATE '



NOTES
In notleo docuosnt 91-14176 baglmlm on ft*
27241. In tho IMUB off Thuraday. Jim IS. 1991.
•ate tho ffelloMlno correction! On Pago 27242, In
tha aacond coluan of tho tablo. In tho c1>th Una
fro* tho bottoai. •PN/9t/iai80448/AS" ahould road
•PS/91/180O87AS".
Thla natlco provldn notification that tho
oliorlthai uaod to •anarato tha priority Hat of
hanrdoua aubstancaa la balm roavatuatad and
ravlead to Includt ooro currant and conprahanalva
Information In tha ranking procaaa. With thla
not lea. ATSOR and EPA aollclt public cosnant on
thla ravlaod approach for ovaluatlng and ranking
hazardous aubatancoa found at NPL altaa. CoMenta
concornlno thla not lea oust bo racalvad by July 18
1991.
Thla notleo amauncaa tha availability of tho Draft
Tonlcological Profllo for FluorldM praparad by
ATS9N for ravloM and cooaant. Thla profllo la to
bo Includad In tha fourth oat of 10 draft
toilcologlcai docuaanta Mhlch profllo tho 16
hazardoua cubatancoa that uara announcad In tho
Fadaral Ragiatar on Octobar 1*. 1990 (59 FR41B81).
CMMfltS HUBt M rtK9lVM OH OT MfOTA O^CMNoMT 16ff
1991.
-------
                   CHEMICALS I        ITING RULES (COIR) DATABASE




RULE CODE. CODE OF FEDERAL REuuu...^     ). AND FEDERAL REGISTER (FR) IKFORNATIM
RULE
COM
161















•ME OF MM « Hit 9
Netabollsai and PhanaKoklnotlc Toot
Buldillm














40CFR
CITATION
7M















PRO-
POSED
MUE
DATE
7-17-91















PROPOSED
RULE FOR
CITATION
96 FR
SB17














FINAL
RULE FOR
CITATION
















FINAL
RULE
PUBLISH
DATE
















EFFEC-
TIVE
DATE
















NOTES
EPA U tawing • proposed nil* to establish • tmt
guldoll- • for generating Mtabollta) and
pharncnklnetlc data (40 CFR part 798). Thla
proposed rut* U • Joint guideline to hansonlie
th« pharwcoklnetlcs testing guidelines of tho
Off Ic* of Tonic SUbotMicM (OTS) and tho Off Ic* of
PMtlcldt Progi-M (OPP). ThU guldelln* IMS
previously proposed In the Federal Register of
Septeaber 15. 1988 (SS FR 3S847). Todsy EPA Is
repreposlng the PK and BetaboIlM test guideline
to provide notice of the harannliatlon effort and
to alloM for additional cement t. Persons Mho
coonented on the Inltlel proposed rule (S3 FR
3584?. Sept. 15. 1988) should bear In Mind that
this proposed teat guideline differs considerably
free) the Septcofccr 1988 version. •
                                        93
                                                                                                                  (10/31/91)
-------
                  CHEMICALS n REPORTING RULES (como DATABASE
MAE CCOi.  CODE OF FEDERAL REGULATION (CFR).  AND FEOEML REGISTER (FR) INFORMATION
RULE
CODE
•rJIS
•r3»
•rill
•rSIS
•rS»
•rJIS
•rS»
•rSIS
•rlTS
MME OF RULE OR MM 0
Fliwl Rule Addition of Onm
Deputing OmlcoU to EFCRA »







OiomOtplttfna. Chemicals; Technical
44 CFR
CITATION
172.65
J72.65
172.65
172.65
172.65
ltt.65
.172.65
.172.65
S7?.6S
FOSED
RUU
MK









RU.I m
CITATUM
-








FIRM.
RUE FOR
CITATIM
» n
11594
» n
51594
55 rt
31594
55 FR
S1S94
SS FR
31594
55 FR
11594
55 FR
S1594
55 FR
S1594
» FR
35434
FIML
RULE
•MUM
DATE
8-3-90
8-S-90
8.J-90
•-S-90
•-S-90
•-3-90
•-S-90
•-S-90
8-30-90
EFFEC-
TIVE
DATE
8-3-90
8-3-90
8-1-90
8-3-90
8-1-90
8-3-90
8-1-90
8-3-90
8-30-90
NOTES
tovn chwIcaU o*M to list of tonle chwIcaU
Kfejwt to roportlnc imdor Soctlon SIS of tho
EMrojney •Iwnlno and Cowley Rlght-te-KiwM Act
of 1986 CEFCRA). >rupoi«d niU of 01/21/90 (55 FR
10472).
TrlddorafluoroMttam (CFC-11) (CAS Ho. 75-69-4}
OlefclorodlfluoraHtluM (CFC-12) (CM No. 75-n-8)
Dlchlorototrofluorottnvw (CFC-114) (CAS Ho. 76-
14-2)
(•ono)thtoropontafluorMthMW (CFC-115) (CAS No.
76-15-1)
RroHdilorodlfluoraMthm (Nalon-1211) (CAS No.
421-01-2)
SraMtrlfluoroMthono (talon- 1301) (CAS Ho. 75-63-
8)
OlbroBOtotrof luorotthom (Holon-2402) (CAS Ho.
124-71-2)
ThU notice comet* MM CM nabtr for MM
choilcol 
-------
                   CHEHICALS C       ITING RULES (CORK) DATABASE




MILE CODE. CODE OF FEDERAL REGULATION     >. AND FEDERAL REGISTER (FR) rNfORKATION
RULE
CODE
163
•ME OF RULE OR PM f
Tact Ing CenMnt Ordar for 4-
vlnylcyclohaxana. Flml luU.
40CFR
CITATION
799.5000
PRO-
POSED
RULE
DATE
12-12-89
PROPOSED
RULE FOR
CITATION
S6FR
5114
FINAL
RULE FOR
CITATION
5ft FR
47912
FINAL
RULE
PUBLISH
DATE
9-23-91
EFFEC-
TIVE
DATE
9-2S-91
NOTES
This final ruU anrmncaa that EPA IIM (lankd an
anforcMbU Tntlni Conunt Ordir for 4-
vlnplcyclohMMna (4-VCN. butadlana dinar. CAS Mo.
100-40-1). tilth nlna aanufacturara. Uio hava
agreed to par for* uAcfironfc affactt,
autapanlclty. phanMcoklnttlca, and aqueou*
volatilisation rtta tntlng on 4-VCH.
                                                                                                                  (10/31/91)
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                   CHEMICALS OH REPORTING RULES  (CORK) DATABASE



RUU CODE, CODE OF FEDERAL REGULATION 
-------
                   CHEMICALS C



RULE CODE. CODE OF FEDERAL Kt
IT ING RULES  (COW) DATABASE



I     ). AW FEDERAL REGISTER (FR)  INFORMATION
RULE
con
Hi
•1
xl
NAME OF RULE OR PM f
Receipt of Application to Operate •
CeoMrclel Polychlorlneted Blphenyl
(PCS) Storage Facility. Notice of
Receipt of Application*.
Disposal of Polydilorlmtad
Blphenyle. Advanced notice of
propoaod rulaaiklng.
Dlapoaal of Polychlorlnoted
Slphenyla; Avallabllttr of Draft
Guidance.
40 CFR
CITATION
761.63(d)
761.60
761.60
PRO-
POSED
RULE
DATE
6/10791
6/10/91
6/10/91
PROPOSED
RULE FOR
CITATION
96 FR
26673
56 FR
26758
56 FR
26745
FINAL
RULE FOR
CITATION



FINAL
RULE
PUBLISH
DATE



EFFEC-
TIVE
DATE



NOTES
1
EPA haa received approximately 100 application
fro* apptlcante requesting approval to operate a
costotrclal PCS atorage facility. Iheae
application are being submitted and reviewed
infer the authority of aectlon 6
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                   CHEMICALS ON REPORTING RULES (CORR) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CM),  AND FEDERAL REGISTER  (FR)  INFORMATION
RULE
CODE



•rJU





NAME OF RULE OR PHN 0




Toxic ChoBlcol RoloMO Reporting.
Cooiuilty Rfght-to-Knou; Sunset
Provisions



4CCFR
CITATION



572.30





PRO-
POSED
RULE
OAfE

1/11/91





PROPOSED
MILE rot
CITATION


W FR
1154




FINAL
RULE FOR
CITATION


MFR
29183




FINAL
RULE
PUB-
LISH
DATE
6/26/V1





EFFEC-
TIVE
DATE


A/26/91





MOTES




EPA U Inulng • f Iml regulation (Mrtalnlng to the
•wnsot" provision of 40 CFR S72.SO(o>, tho rulo
thot IsploMnts MCtlon III of tho tergsncy
Plomlno ond CoMunlty Rlght-to-KnoM Act. This
Knot rulo rotolns rsngo report Ing tilth only Minor
•odlllcotlono.
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                   CHEMICALS



RULE CODE. CODE OF FEDERAL RE
IT ING RULES (CORK) DATABASE




     •). AND FEDERAL REGISTER (FR) iUFOKNATION
CON
M7
•7
«7
•7
HANE OF RULE OR PNN ff
Dlbenio-para-dlo«lns/Dlbeniofurana In
Nleochod Mood Pulp mo Paper
Products; Referral far Action
PrcpoMd Regulation of Land
Application of Sludge fro» Pulp ond
Popir NIIU Using Chlorine ond
dilorlns Derivative Oleachlng
ProcsMM. Proposod rulo.
Proposed Land Application of Sludga
troo Pulp and Paper Hills Using
Chlorine Derivative gioochlng
Processes; Correction. Proposod
rulo, correction.
Technical Ajeendssnta to Tost Rules
ond Consent Orders. Final Rule.
40CFR
CITATION

744
744
766
PRO-
POSED
RULE
DATE

5/10/91
6/13/91

PROPOSED
RULE FOR
CITATION

56 FR
21802
56 FR
27222

FINAL
RULE FOR
CITATION
55 FR
53047


56 FR
23221
FINAL
RULE
PUBLISH
DATE
12/26790


5/21/91
EFFEC-
TIVE
DATE
12/29/90


5/21/91
NOTES
EPA/TSCA section 9(a) referral to FDA for action
neadid to protect public health ond the
anvlronaent fro* use of food contact pipers
contoalneted tilth chlorinated dlbonio-psra-dloxlns
ond chlorinated dlbeniofursna.
This proposed rule would regulate the use,
disposal, end distribution In coanerce of process
Mssteuster treatment sludges Intended for land
application fraa pulp and paper Bills employing
chlorine or chlorine derivative-based bleaching
processes (hereafter referred to as "paper Bill
sludge- or -sludge-). This rule Is proposed under
the authority of section 6(a) of the Toxic
Substances Control Act (TSCA) to prevent
unreasonable risks to wildlife andhuams
presented by exposure to 2.3.7,8- •
tetrechlorodlbenio-p-dlMtn (TOO) and 2.3.7.8-
tetrachlorodlbeniofwan (TCDF) present In paper
•III sludge. Written consents In triplicate oust
be received on or before August 8. 1991.
EPA Issued o proposed rule on land application of
sludgo frosj pulp and paper Bills using chlorine
derivative bleaching processes In the Federal
Register of Nay 10. 1991 151 FR 21802). The
paragraph estlootlng the public burden for
Information collection Mas Inadvertently onltted.
This docuetnt corrects that oBlstlon.
Pursuant to 40 CFR 790.55 and 790.68. EPA has
approved by letter certain Modifications to test
standards end schedules for diaries! testing
prograos under section 4 of the Toxic Substances
Control Act (TSCA). Because these aodlflcatlont
do not significantly alter the scope of a test or
significantly change the schedule for Ite
coopletlon. EPA approved these requests ulthout
seeking notice end coMnt. EPA Issued an Interlai
final rule published In the Federsl Register of
September 1. 1989 (54 FR 36311).
                                        99
                                                                                                                  (10/31/91)
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                   CHEMICALS M REPORTING RULES CCORR) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE



•rSIS



NAME OF RULE OR PMN f




Coppor Mitholocyonlm MgMnU; Toxic
Choricol Rtltut Rtportlng; CoHunlty
Rlght-to-KnoM. Flml RuU.


40 CFR
CITATION



377.65



MO-
POSED
RULE
DATE

5/15/89



MUMMED
RULE FOR
CITATION


54 FR
20864



FINAL
RULE MM
CITATION


56 FR
23650
.


FINAL
RULE
PUB-
LIU
DATE
5/23/91



EFFEC-
TIVE
.DATE


6/24/91



NOTES



1
EPA U praulgrtlnf • nil* to drioto flfMnt Dim
15. PlgMftt firoon 7. oral PlflMnt Croon J6 fro*
rtporllng roqulroMiito undtr ,lh« category "copp«r
ce^ouidi^ fro* the list tmlc di«rieaU untor
•Mtlen 111 of tho EMrgoncy Pltmlng ond CoMunlty
Rlght-to-Knw-Act.
-------
                   CHEMICALS



MILE CODE. CODE OF FEDERAL i
RUNG RULES (COM) DATABASE



I     I.  AM) FEDERAL REBISTER (FR) INFORMATION
RULE
COM



x9








•
•MB Of KU « PM »




•otic* of Opm Hooting of tlw
Negotletod Ruloaeklng Advisory
Coarittce; Lead Acid lattery
Recycling iulo






40 era
CITATION













MO-
POSED
RULE
DATE

B/2S/V1









PROPOSED
RULE FOR
CITATIOR


96 FR
42972








FINAL
RULE FOR
CITATION












FINAL
RULE
PUBLISH
DATE











EFFEC-
TIVE
OATE












MOTES



I
At required by Mctlon 9(s)(2) of the Fodsret
Adrisory Canutes Act (Pub. L. 92-463). M «rc
giving notice of the flnel eoetlng of the Advisory
CoMlttoe to negotlete e rule to recycle Ited ecld
betterlee. The purpose of the Bsetlng Is to
discuss rtcont dsto aensrstod by EPA and to
further dtt train* whether the casilttM should
continue Mork tomrds reechlng o consensus an s
rule to proMote recycling of lesd ecld faetterles.
The SMtlng Mill be held on Septsofaer 17. 1991.
                                       101
                                                                            (10/31/91)
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                   CHEMICALS OH REPORTING RULES (CORR) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION fCFR). AMD FEDERAL REGISTER (FR) INFORMATION
RULE
CODE



erJIS







NAME OF MILE Oft PNN 0




Statement of Policy and Guidance for
Petition* inter Section SIS of the
EMrgmcy Planning ml Coaauilty
Rlght-to-KnoM Act of 1986. Not let.





4C CFR
CITATION



S7i







PRO-
POSH)
RULE
DATE









PROPOSES
RULE FOR
CITATION










FINAL
RULE FOR
CITATION


MFI
23703







FINAL
RULE
PUB-
LISH
DATE
5-23-91







EFFEC-
TIVE
DATE


5-23-91







NOTES




This donoMiit outllnM EPA'» policy concerning tho
provision for petitions to del let Individual
•Mtera of tho wtil covpound catogorlos roportoblo
undtr section 111 of tho EMrgoncy Planning ond
Comnlty Right-to-Knw Act of 1986. ThU FR
notlco oln provldM gulchmco rogardlng tho
appropriate aupport daeuaantatlen that Hill bo
nacaaaary to at Ion tho Agency to oaka declalora on
auch petltlona.
-------
         APPENDIX 8




PREMANUFACTURE NOTICE (PMN)
-------
                   CHEMICALS M REPORTING RULES (CORR) DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CfR).  AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE



•rJU







NAME OF RULE OR PMN 0




Tralc OiMlcal'Releeso Reporting;
Pollution Prevention Information






40 CFR
CITATION



572







PRO-
POSED
RULE
DATE

9/25/91







I'ROPOICD
MAE FOR
CITATION


MFI
48*75






FINAL
RULE FM
CITATION










FINAL
RULE
PUB-
LISH
DATE








EFFEC-
TIVE
DATE










NOTES




EPA !• proposing to odd ••viral data aleawita to
the currant Toxic Choalcat Release Inventory (TRI)
reporting requirements. ThU propoNd nil* Mould
Incorporate Into Misting regulation* the aourco
reduction and recycling Intonation specified In
the FM that all facllltlea subject to reporting
under section SIS oust provide beginning In the
1991 reporting (calendar) year. Coawnta oust be
subattted oh or before Noviefter 12. 1991.
-------
    A             A   U.S. ENVIRONMENTAL PROTECTION AGENCY
                             INSTRUCTIONS MANUAL FOR PREMANUFACTURE
                             NOTIHCATION OF NEW CHEMICAL SUBSTANCES
  PA-7710-25(l)(January1991)             OFFICE OF TOXIC SUBSTANCES         Washington, D C. 20460

     The U S Environmental Preiecaon Agency (EPA) has prepared this manual to assist you in submitting. a premanutacture nonce under section 5 of
     (he Toxic Substances Conm Act (TSCA) The manual provides instructions on subminng a premanulacture nonce, asserting confidentiality claims
     completing ine notoa form, and submitting test data and optional information Before consulnng this manual, you should read the Premanufacture
     Notice Requirements and Review Procedures (Premanufacture Notification Rute)(40 CFR 720)
                                          TABLE OF CONTENTS
I. INSTRUCTIONS FOR COMPLETING THE PREMANUFACTURE NOTICE FORM                  Page

   A, General Instructions	  1
   B. Confidentiality	  1
   C. Optional Information	    2
   D. Test Data and Other Data 	   2
   E. Type uf Notice	     .         .  .         3
   F Certification	      .   .       3
   G. Completing the Parts of the Notice Form	        ...  4

      Part I   General Information	  4
              Section A • Submitter Indentrficaten	          4
              Section B - Chemical Identity Information	      	   4
              Section C - Production, Import, and Use Information	,	  8

      Part II  Human Exposure and Environmental Release	  10
             Section A - Industrial Sites Controlled by the Submitter	  10
             Section B • Industrial Sites Contolled by Others	  12
             Pollution Prevention and Recycling Information (Optional)	  13
      Part III  List of Attachments	  13

   SUPPLEMENTARY INFORMATION	  14

   A. Who Must Submit a Premanufacture Notice	   14

   B. Substances Which Must be Reported	  14
     1. General	  14
     2. Bona fide request for a TSCA Inventory search	  14

   C. Substances Excluded from Notification	  14
     1. General  	  14
     2. Research and development exemption	  14
     3. Test marketing exemptions	   15
     4. Section 5(h)(4) exemptions (Low Volume, Polymer)	  15

   D. When to Submit a Node*	   16

   E. Consolidated Notice	  16

   F. Submission of Information by Others	   16
     1. Submission by an agent	   16
     2. Joint submissions	   16

   G. Consultation with EPA Concerning  the Premanufacture Notice 	   16
     1.  Before notice submission	   16
     2.  During notice review	   17

   H. Notice of Commencement of Manufacture	     	   17

   I.  Recordkeeping	   17

Appendix A • Examples of Test Data	  19

                                                                          @ Printed on Recycled Paper
-------
                   CHEMICALS ON REPORT ING RULES (TOBR) p«'«»»M
mac coat, CODE OF FEDERAL REGULATION . AND FEDERAL REGISTER <»R>
RULE
CODE
t6
16
NAME OF MILE 01 fm •
NMltyl Oxl*; Testing Consent
Agreement Devejopeent
Revocetlon of NMltyl Oxide Final
Rule
40CFR
Cf TAT ION
799.9000
799.2900
PRO-
POSCD
RULE
DATE
10-2-90
9-9-91
PROPOSED
RULE FOR
CITATUM
» FR
40234
96 FR
43897
FINAL
RULE FOR
CITATION
96 FR
43878

FINAL
RULE
PUUIM
DATE
9-9-91

EFFEC-
TIVE
DATE
9-9-91

NOTES
This nil* orawunceo that EPA HM signed en
enforceebU testing cement order nidi four of the
evwfocturers of Hsltyl exldt.
This dscueent enneuncee EPA's propose! to revoke
the Neeltyl Oxide Flnel Test Rule et 40 CFR
799.Z500. EPA le proposing to revoke this rule
beceuse four of the eanuf ecturcre of NO heve egreed
to enter Into e content order tilth EPA to per f one
certoln heelth effects teste.
-------
                                 I. INSTTIUCT1ONS FOR COMPLETING THE
                                     PREMANUFACTURE NOTICE FORM
 A.  General hstrucflom
 Complete the premanufacture notice (PMN) form using a
 typewriter or by pnntng legibly in black ink  Information
 which is not submitted on a photocopy of the form
 available from EPA (e g.. an electronically generated form
 created by utilizing commercial form-making software)
 must be in a format pre-approved by the  Agency.
 Approval can be obtained by contacting the Office of
 Toxic Substances (OTS) Document Control Officer (OCO)
 (TS-790). whose address uppaars on page 1 of the form

 Ai! infoi-maticr, most be in English.  Provide ail information
 requested on the notice form to the extent that you know
 or can reasonably ascertain it.  If you do not know or
 cannot reasonably ascertain the information, enter 'NK*
 (for not known or  not reasonably ascertainaWe). You  may
 attach continuation sheets to any subsection or item on
 the form.  Mark (X) the appropriate box on the notice  form
 if you attach continuation sheets.

 The use of the term 'manufacture' in this manual includes
 both manufacture and import  Importers must fully
 comply with the information requirements outlined in the
 Premanufacture Notification Rule. However. Importers are
 not required to submit any data which relates solely to
 exposure to humans or  the environment outside the
 United States under §720.50(d)(3) of the Rule. Importers
 must submit non-exposure data such as data on health
 effects (including epidemiologteal studies), ecological
 effects, physical and chemical properties, or environmental
 fate characteristics and exposure information (on sites
 under their control within the United State*).

 You may photocopy the notice form, sections of the form,
or this manual as  frequently as you need.

 Send your completed notice to the OTS OCO (TS-790).
whose address appears on page 1 of the  form.

A user fee must be remitted for Section 5 notices in
accordance with 40 CFR 700.45. You must create a
 personal aipha-numeric  Identification number to identify
and link your notice wflh the remittance fee.  This six digit
 number must be placed on the first page of the form  in
the boxes that have been provided.  This  number must
also be placed on your fee remittance which is sent to:
 EPA. HO Accounting Operations Branch (PM-226), P.O.
360399M. Pittsburgh. PA. 15251-6399. Attn. TSCA User
 Fee.  Once the check has been processed and certified
under 40 CFR 700.45(e). a listing of the TS User
 Identification Number is sent to EPA Headquarters. EPA
 Headquarters then verifies that the appropriate remittance
with a TS identification number corresponds to a user fee
identification number on a PMN and further processing of
the notice commences. However, if a problem arises in
the payment procedure. 0 ••. insufficient funds, improper
usage of the TS identification number),  then the Section 5
notice will be given incomplete notice status in
accordance with 40 CFR 720.65(c). The EPA will inform
the submitter in writing if this action is taken   If a notice
is declared incomplete for these or other reasons as
described at 40 CFR 720.65(c). any fee  remitted will be
held by the Agency for thirty days to allow 
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                   CHEMICALS OH REPORTING RULES (COM) DATABASE



RULE CODE, CODE Of FEDERAL REGULATION (CFR).  AND FEDERAL REGISTER (FR) INFORMATION
RIME
CODE
146
NAME OF RULE OR PNN «
Reopening of Casaent Period For
Proposed Tnt Ruin; Office of.
Drinking tutor Chwlcolei
Cyelohtxarw; l.o-NeiMMthyleno
OMsocysnete; and H-e»thylpyrrol(dono
40 CFR
CITATION

PRO-
POSED
RULE
DATE
7-15-91
PROPOSED
RULE FOR
CITATION
UFR
32292
FINAL
RULE FOR
CITATION

FINAL
RULE
PUBLISH
DATE

EFFEC-
TIVE
DATE

NOTES
EPA Is reopening the cosasnt period for the
proposed toil rules on heuMthylsne dllsacysnsto
for 60 dsys to penslt further camnt on the
findings e*d§ for these chealeels under TSCA
section 4(e)(1)(D)(l), In light of the proposed
policy srtlculsted elsewhere In todsy's Fedtrel
Register for eaklng legsl findings inter TSCA
section 4(e)(1)(B)(l>. Submit written amount* on
or before SeptMfcer IS. 1991. '
-------
 anticipated completion date   N significant preliminary
 results or final result* are obtained prior to the completion
 of the notice review period or any other additional
 information significant to the review of the notice becomes
 available to you, you must submit this information within
 10 days of receipt, but no later than 5 days before the
 end of the review period  If information becomes
 available during the last 5 days of the review period, you
 must immediately inform EPA by telephone.  Examples
 of the types of test data you must submit are provided in
 Appendix A of this manual.  In addition, a Physical and
 Chemical Properties Worksheet now appears on the last
 page of the form. For additional information on health
 and safety studies and on submitting  test data, see
 § § 720 3 and 720 50 of the Premanufacture Notification
 Rule. Attach test data to the note* form and reference  it
 by page number in Part III. List of Attachments.

 You are not required to submit any data previously
 submitted to  EPA with no claims of confidentiality if you
 identify the office or person to whom you submitted the
 data, the date it was submitted, and. if appropriate, a
 standard literature citation.  If you submitted the data with
 claims of confidentiality, you must resubmtt the data with
 the notice and any daim of confidentiality under §720.80
 of the Rule.  You also are not required to submit data
 related solely to product efficacy. This exception does not
 apply to information required in the notice, test data, or
 other data.

 E Type of Node* (Page 1)

 Please check the type of notice submitted.  If this notice is
 for a oonsofidslBd PMN, the number of chemicals
 included in the notice should be entered on page one In
 the space provided.  A separata PMN  number is assigned
 to each chemical substance identified  in a consolidated
 notice. Approval for a consolidated PMN notice must be
 obtained from the Prenotica Coordinator prior to
 submission.  See Section II, Part E of this manual for
further information on submitting a consolidated notice.

 The Skjnjficant New Use Nodoa (SNUN) box should be
marked for any notice that Is submitted in accordance
with a SNUR.
If the notice being submitted ia for a pc
application, the type of polymer exemption criteria met as
specified at 40 CFR 723.2SO(e)(1) or e(2) must be
checked. To meet the criteria for an e(1) polymer, the
polymer must have a number average molecular weight
greater than 1000.  To meet the criteria for an e(2)
polymer, or polyester polymer, the polymer must contain
a minimum of two carboxylic acid ester linkages, at least
one of which links internal subunris together and is
manufactured solely from one or more of the reactanta
listed in the Table A 40 CFR 723.2SO(e)(2).
The hterrnedteto PMN box should be checked if this
notice is for a chemical substance which is an
intermediate used in the production of a final product for
which a separate notice is submitted simultaneously.  K an
intermediate (or senes of intermediates) is submitted with
a final product PMN, a reduced fee of $1000 must be
submitted for each Intermediate PMN.  The final product
PMN is subject to the full fee of $2,500.  In addition, the
intermediate PMN must identify the final product.
Separata user fee identification numbers must be
generated for and appear on each notice, although, a
single check may be remitted bearing all user fee
identification numbers for an intermediate^) and final
product sequence. For further information on
•intermediate PMNs* see 40 CFR TOO 43 and 700 45QR

F. Certification   (Page 2)

The official named in Part 1, Section  A of the form, as the
person submitting the notice, must sign the certification
on page 2 of the notce form.  This official is responsible
for the truth and accuracy of each statement in the
certification. If an agent assist* you in preparing the
notice, the agent must also sign the certification.
All signatures must be original.

In addition, the submitter must check certain 'user fee*
certification statements as appropriate as required at 40
CFR 700.  If a PMN is submitted. Including Polymer
Exemption application, consolidated  PMN or SNUN, the
company must pay the  remittance fee identified in either
40 CFR 720.45(b)(1) (a small business concern that remits
a fee of only $100) or 40 CFR 700.45(b)(2) (all others who
must remit a fee of $2,500). A small business concern is
one who's total annual sales taken together of all sites
owned or controlled by the foreign or domestic parent
company is below $40 million for the fiscal year preceding
the date of the submission of the applicable section 9
notice (sea 40 CFR 700.43).

If the new chemical substance is submitted as a polymer
exemption application following the criteria at 40 CFR
723.250, additional certification statements must be made
by checking the appropriate box for the user fee
statement that  applies and by checking the box that
certifies that the new chemical substance meets the
definition of a polymer, is not specifically excluded from
the exemption  and meats the  conditions of the exemption

When using the PMN form (recommended, not required)
to submit a Low Volume Exemption (LVE) application in
accordance with 40 CFR 723.50, all three of the
corresponding  LVE certification statement boxes must be
checked to acknowledge that you will manufacture under
the terms of the exemption. There is no fee for a LVE
Page 3
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                   CHEMICALS OH REPORTING RULES (CORR) I,*!ABASE




RULE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
tS4
NAME OF RULE OR PNM f
Reopening of CeoMnt Period For
PropoMd Tost Rulot; Off Ico of
Drinking Water Oieilcolo:
Cyclohtxane; 1.6-HeiUMothylene
Dlisocyansto; and N-Mthytpyrrol (done
40 CFR
CITATION
199
POSED
RUE
DATE
7-15-91
PROPOSED
RULE FOR
CITATION
56 FR
12292
FINAL
RULE N»
CITATION

FINAL
RULE
PUM.IM
DATE

EFFEC-
TIVE
DATE

NOTES
EPA U reopening MM coBBant period for tho
proposed tost rutot on tho Offlco of Drlnklm
Water ChwIcaU for 60 dtyo to poralt further
cpoBint on tho findings SMHI for thoso choilcolo
under TSCA section 4(e)(1)(l)(l). In light of tho
proposed policy ortlculotod elsewhere In todsy'o
Federel Register for asking legol findings under
TSCA section 4(o>(1)(l>(l>. Sutalt wit ten
ceoMnts on or before Septcober 15, 1991.
-------
Class 2 substance or a polymer  A Class 1 chemical
substance is a substance whose composition, except for
impurities, can be represented by a definite chemical
structural diagram. Examples of such substances are 1,3-
butadiene, benzene, and sodium chloride.  A Oase 2
          Aslanes is a substance whose composition
      I be easily represented by a definite chemical
structural diagram. Such substances are generally derived
from natural sources or complex reactions. Their
composition may oe complex, difficult to characterize, and
variable.  Examples include chlorinated naphthalene, the
glycerot monoester of hydrogenerated cottonseed oil
acids, or a reaction product of specified reactants.  A
polymer is a substance composed of molecules
characterized by the regular or Irregular repetition of one
or more types of identical monomeric units.  In most
cases, the number of monomenc units Is quria large ar.d
not precisely known.

If the substance is dearly a Class 1 or 2 substance, then
items a-d of Question 1 on Page 4 must be property
completed. If the  substance meets the definition of a
polymer, then items a-c of Question 2 on Page 5 must be
addressed and answered appropriately. M an uncertainty
revolves around the chemical substances Identification as
either a Qass 2 substance (or. Class  1) or as a polymer,
then both Questions 1 and 2 on Pages 4 and 5 should be
completed in full or contact the Prenotice Coordinator for
further assistance.  M the variability of the composition of
a reaction product Is too complex to be described as
distinct individual components, then reaction  product
nomendature Is employed.  If however, components of a
reaction product can be readily Identified and will always
be present in  the reaction product, then the components
should be specifically identified and may be listed
individually on the TSCA Inventory. All reaction products
may be reported as Class 2 substances.
1. Class 1 or CtaH 2 <
 a.  Mark (X) the appropriate class.

 b.  Enter the specific chemical name of the new
     chemical substance.

     For a Class 1 substance, the name must be a dear
     description of a unique substance. In describing the
     chemical substance, the EPA prefers Chemical
     Abstracts Service (CAS) chemical nomenclature be
     used for Identification purposes.  There is a separate
     box  in question one,  item c on page 4 for entry of
     the CAS number. The Agency encourages
     submitters to have contact with CAS prior to
     submission in order to obtain concise chemical
     identity information.  Use standard rules of chemical
     nomenclature, such as from CAS or,  although not
     preferred, the International Union of Pure and Applied
    Chemistry (IUPAC) to identify the new substance.
    Identify the positions of attachment of chemical
    groups or of unsaturaton. if any, by using locaiits
    The chemical name should contain all of the
    information known about the details of the structure
    and should permit the drawing of an unambiguous
    chemical structural diagram.

    The chemical name of a Class 2 substance must
    describe the chemical substance aa completely as
    possible. In some cases, the name  may be similar
    to the names used to describe Class 1 compounds,
    but H should indicate the substance's multiple
    components. For example, the name
    polycMonnatecl b'phenyl indicates a composition
    that has multiple components varying both in the
    number and tt<* placement of the substatuent
    chlorine atoms.  In other cases, the best possible
    name may only identify the substance as a reaction
    product of specified reactants, for example,  the
    anhydrosorbitol monoester of hydrogenated castor
    oil adds.

c.  Provide a molecular formula that gives the Identity
    and number of atoms of each element contained In
    the molecule. For example, CgHg is the molecular
    formula for benzene.  When the substance is not
    molecular or when the exact number of &»me In
    the molecule la indefinite, such as sodium chloride,
    which is an Infinite crystal, give the relative numbers
    of each element's atoms.  Also enter the CAS
    Registry Number (if one has been assigned  to the
    substance).

 d.  For a Class 1 substance, provide a structural
    diagram. The diagram should dearly indicate the
    identity of the atoms  and the nature of bonds
    joining the atoms. Any ionic charges or
    stereochemistry should be shown dearly. In the
    description of the nature of the reaction or process,
    as much specific detail as possible should be
    provided on the reaction conditions, 0.e.
    temperature, time, etc.) and on the relative amounts
    of reactants.  AS known stereochemical details
    should be provided.  Carbon atoms in ring systems
    and their attached hydrogen atoms  need not be
    explicitly shown. Where applicable, specify the
    proportions of Isomers or tautomertc forms, degree
    of neutralization, etc.

    For a Qass 2 substance:

    (1) List trie immediate precursor substances by
       chemical name and CAS Registry Number fit
       known).

    (2) For substances prepared by chemical reaction.
Pages
-------
                   CHEMICALS ON REPORTING RULES (CORR)  DATABASE



RULE CODE. CODE Of FEDERAL REGULATION (CFR).  AND FEDERAL REGISTER  (FR)  INFORMATION
RULE
CODE
tss
tss
NAME OF RULE OR PMN f


4C CFR
CITATION
799.3300
799.3300
PRO-
POSED
RULE
DATE


PROPOSED
RULE FOR
CITATION


FINAL
RULE FOR
CITATION
55 FR
3087V
SS FR
50879
FINAL
RULE
PURUSN
DATE
12/11/90
12/11/90
EFFEC-
TIVE
DATE
12/11/90
12/11/90
NOTES


p-PhtfiyltmdlMlm (CM No. 106-50-3)
-------
   Column (5) • CBI dalm.

   Column (6) - Indicate the maximum weight percent of
   each reactant that may be present as
   a residual (unreacted matenal) in the polymer as
   manufactured for commercial purposes.

   Column (7) • CBI daim.

   Note that you must make separata confidentiality
   claims for reactant identity, composition information,
   and residual reactant information.

c.  Provide a simple, representative structural diagram
   that illustrates what you know or can reasonably
   ascertain concerning the key structural features of tna
   polymer molecules. For example, you could identify
   the linkages formed during polymerization, the
   functional groups present, the range and typical values
   for the number of repeating structural units, and the
   relative molar ratios of the precursors.  Indicate if the
   repeating substructures are arranged In a nonrandom
   order such as in  graft or block arrangements.  For
   example:

    HOR-O-(C-R--C-O-*O)n-H
     when) R may be either
             - or -CH2CH-
                     CH3
     and R' may be either
     a benzene ring or
   Approximate relative mole ratios of precursors:

   diethyl taraphthalata:     2.0
   adipic acid              1.5
   ethylene grycol          1.0
   propylerw glyool         3.0

3. Impurities  (Page 8)

 a. Identify each impurity you reasonably anticipate will be
   present in the substance aa manufactured for
   commercial purposes. An impurity to any chemk—l
   substance tnat to unbitsfitionalty present in the new
   chemical substance.  List all impurities (regardless of
   weight percent). If the substance contains some
   unidentified impurities, also enter "unidentified" in
   column (a). Do not include any substances that are
   mixed with the new substance after manufacture.

   In addition to impurities, list in this section other
   chemical substances, such as solvents, inhibitors, etc..
   that also may be reasonably anticipated to be present
                                                                in the chemical substance as manufactured for
                                                                commercial purposes.

                                                                You should consider the following in identifying
                                                                impurities:
                                                                 (1) Chemical and in
                                       • oftsn
                                                                performed on the chemical substance during research
                                                                and development to characterize the substance before
                                                                it undergoes health effects or environmental effects
                                                                testing, to optimize product performance, or to
                                                                understand process chemistry and optimize output
                                                                (2) Manufaciurtng |
                       MS chemtey • including
  feedstocks, feedstock impurities, byproducts, and
  intomieai&tes both from the major rasc£cn pathway
  and from significant side reactions.
                                                                                            • operations which
  determine the nature and level of impurities that may
  be present in the chemical substance,

  Identify bnpurWea as specifically as possible.  You
  should give the following information:

     (1) the specific chemical name; or

     (2) a dass or range of structures (e.g., Cg - C^
         fatty add salts or polychlorinated cyclic and
         acyclic hydrocarbons in the range C5 • C12): or

     (3) the source (e.g., pyrorysis products of cellulose
         or coal tar residues).

  Include the CAS Registry Number if available.

  b. Enter the maximum weight percent of each impurity
  in the new chemical substance in column (b).  If the
  wrurtiirK?^ contains unidentified impurities, enter the
  total weight percent of unidentified impurities in column
  (b).

4. Synonyms - Enter common chemical names by which
  the new chemical substance may be identified in the
  scientific or technical literature, Including the names or
  codes used to identify the new chemical in test data or
  other data which are attached to the notice.
& Trad* ManUBcaUon - Enter any trade name under which
   the new substance has been or will be marketed.
   Report all trade names or brand names, even if they
   are not registered.

S. Generic chemical name - If the new substance's
   identify is claimed as confidential, enter the generic
   chemical name that is only as generic as  necessary to
   protect the confidential chemical identity.  The generic
Page
-------
                   CHEMICALS ON REPUTING RUES (CORR) DATABASE



RULE CODE,  CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
157
t57
t57
t57
t57
t57
157
157
t57
157
157
NAME OF RULE OR PNN *
Nultf-wiMtance Rut* for the Teatlni
of Neurotoxlclty '




.




I
40 CFR
CITATION
799.5050
797.5050
799.5050
799.5050
799.5050
TV). 5050
799.5050
79V.50SO
799.5050
799.5050
790.5050
PRO-
POSED
RULE
DATE
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
3-4-91
PROPOSED
RULE FOR
CITATION
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
56 FR
9105
FINAL
RULE FOR
CITATION











FINAL
RULE
PUB-
LISH
DATE











EFFEC
-TIVE
DATE


.








NOTES
EPA U propoBliv • twt rale infer Section 4(«) of TSCA
to obtain neurotoxlclty data for 10 volatile tubetancee
that have attotantlal production, for which there te/a»y
be atBMtantlal huam exposure.
Acetone (CAS No. 67-64-1)
n-Aayl acetate (CAS No. 628-63-7)
1-Rutanol (CAS No. 71-36-3)
n-Buty( acetate (CAS No. 123-86-4)
Dlethyl ether (CAS No. 60-29-7)
2-Ethoxyethanol (CAS No. 110-80-5)
Ethyl acetate (CM No. 141-78-6)
laotautyl alcohol (CAS Ho. 78-81-1)
Methyl laobutyl ketona (CM Ho. 108-10-1)
Tetrahydrofuran (CAS No. 109-99-9)
-------
   Column (7)  CBI daim

   Column (8)  Mark (X) to indicate if the category of usa
   is site-limited or whether the substance is intended for
   industrial, eommerelaJ, and/or consumer use. as
   defined below.

   Site-limited - The substance will be used only on the
   contiguous property unit where it ia manufactured  and
   not intentionally distributed outside that sita except for
   waste disposal. This includes all factories, storage
   places, and warehouses at the site. An example would
   be an intermediate which is further reacted on-srte to
   produce a pesticide.

   Constimar • The new chemical substance or products
   containing the  substance will be used by private
   individuate in or around a residence, or during
   recreation, or for any other personal use or enjoyment,
   e g.. automotive polish, dyed wearing apparel,
   household cleaners, etc. If a consumer use is
   identified, then the EPA requests the following
   information to be provided on an  attached continuation
   sheet: a detailed description of the usa of the new
   chemical substance expected In consumer products
   and any reactions that occur causing the substance to
   lose its Identity in the consumer product.

   Industrial - The new chemical substance or products
   containing the substance will be used at the site of
   other manufacturers or processors, e.g., textile dyeing,
   paint formulation, use of a curable resin to manufacture
   an  article.

   Commercial • The new chemical substance or products
   containing the substance will be used by a commercial
   enterprise providing a consumer service, e.g., use by
   commercial dry cleaning establishments, use by
   painting contractors, or use by roofers in commercial
   building construction.

   Mark aH boxes, as appropriate. For example, a
   surfactant hi an automobile wax may have a consumer
   use in liquid wax, a commercial use In auto washes,
   and an industrial use by automobile manufacturers.
   Mark the binding option statement where applicable.
  Note:  You must mafce separati
nfUenflanty claims
  for the description of tne category of use, the percent
  of production devoted to each category, the percent in
  formulation, and category of use information.

  The information in this section is used to evaluate
  potential exposure and release of the new substance.  If
  you wish to provide any additional information which
  would assist in this analysis, it may be submitted as
  optional information.
                             c. Generic use description - For each category of usa
                               description which is claimed as confidential, provide a
                               generic description of the category. Identify the
                               category of use to which the generic description
                               applies.  The generic use should reveal the intended
                               category of use of the maximum extent possible.  For
                               example, the specific use of a new substance as an
                               antioxidant In a lubricant could be described
                               genencalry as s lubricant additive; a fiber-reactive dye
                               for nylon carpeting could be described generically as a
                               dye for fibers. If such a generic description does not
                               provide a sufficient indication of potential exposure, the
                               description can ate describe the degree of
                               containment of the new chemical substance, as shown
                               In the list below; however, a generic use descripUui
                               thai soWy describes the degree) of containment such
                                          orMfispefi^^ use"  Hi not
^^MW^^K «^
ueojrss) or

(a) destructive use



(b) contained usa
(c) open, non-dispersive
   use
(d) dispersive usa
                               (o) highly dispersive use
                               (0
                                                        (e g., fuels, fuel additives
                                                        chemical intermediates)

                                                        (e.g., catalysts used in  ,
                                                        dosed processes, certain
                                                        photographic chemicals.
                                                        capacitor fluids)

                                                        (e.g., printing inks, textiles,
                                                        dyes, plastfcaers, adhesives,
                                                        liquid paints, resins)

                                                        (e.g.. cutting fluids, fabric
                                                        softeneis, automobile tire
                                                        rubber)
                         (e g., pesticides, fertilizers,
                         salt for de-icing, paint
                         solvents, spray paints)

                         (describe)
                                                          In tfw notion d copy oc
                                                lie of any hazard warning statement.
label, material safely data sheet (MSOS). or other
Information which will be provided to any person
regarding protective equipment engineering controls,
or practices for the safe transport use. or disposal of
the new chemical substance. If hazard warning
information !s not yet prepared, descnbe the statement
you intend to provide, if any. You are not required to
develop hazard warning statements for this notice if
you do not otherwise intend to do so.  Identify copies
of hazard warning statements or other hazard
information that you  attach in Part 111, List of
Attach ments.
Page 9
-------
                   CHEMICALS ON REPORTING KtUlS |ii*«i  • •  in  •




RULE CODE,  CODE OF FEDERAL REGULA1IOH (CFR).  AND fEOEBAl «(CISM«  ("•)  :
RULE
COCE


159


















tS9


159


tS9

159


159

MANE OF RULE OR PIN ff



BroMlneted Flee* Reterdanta (Group
1); Proposed Teat Rule































40 CFR
CITATION


799,798,
7VJ


















TOO si in
IwtmJ 1 III

799.5110


79?.S110

7W.S110


7W.5110

PRO-
POSED
RULE
DATE
6/25/91


















6-94-O1
C* Tl

6-25-91


6-25-91

6-25-91


6-25-91

PROPOSED
RULE FOR
CITATION

56 n
29140


















Mmm
rW
29140

56 FR
29140

56 FR
29140
56 n
29140

56 Ft
29140
FINAL
MILE FOR
CITATION

































FINAL
RULE
PUBLISH
DATE
































EFFEC-
TIVE
DATE

































NOTES



EPA U leaning • proposed ttst ruU under MCtlon
4(a) of tlw Toxic Sutetoncea Control Act (TSCA) In
rotponu to tho Interegency fitting Cewslttee
(IK) dnlgnotlon of tho following flvo broil rated
float rotordontt (SFRs) for health and
omlronMntal offoctt and diomlcal fato toatlng
(1) pantabroiBdlpHanyl othar (PBDPE; CAS. No. .
(32534-81-9). (2) octataraaodlBhanyt othar (OBDPE;
CAS. No. S25S6-52-0). (S) dacabroMdlplienyl athar
(ORDPE; CAS No. 1163-19-5), (4) 1.2.bla(2,4,6-
trlbroaoBlianoHy)athana (8T8PE; CAS. No. 37853-59-
1). and (5) haNabroMcyclododeeana (HBCD; CAS. No.
3194-55-6) EPA hat concluded that: activities
Involving thaaa BFRs oay pose an unreasonablt risk
of Injury to huoan health or tha environment aa
suggested by certain preliarinary data; existing
data ara Inadequate to aaaaaa tha rlaka to hunan
health and tha envlronaant posed by exposure to
these substances, and testing of each of tha flvo
BFRa la necessery to develop such data. Subalt
written coaawnta on or before Aucuat 26, 1991.

9) shall be teated in accordance tilth thle
aectlon.
Octabroandlphenyl other (OBDPE; CAS No. 32536-52-
0) ahall be totted In accordance tilth thla
aectlon.
OecabroMdlphanyl ether (DBDPE; CAS No. 1163-19-5)
ahall be tested In accordance tilth thla section.


No. 37953-59-1) ahall be tested In accordance ylth
thla aectlon.
HexsbroMcyclododecene (HBCO; CAS No. 3194-55-6)
ahall be tested In accordance with this section.
-------
   For exampje. -


           SAMPLE MANUFACTURING OPERATION
 Stannic
 Chlonde
 800 kg/batch
Methylene
cMonde
200 kg/batch
 _r
             Mix Tank
     T
Tnbutyl
aluminum
900 kg/batch
Sodium
chlonde  —_
300 kg/batch

To Recycle
Jr
Reaction
Mix
Tank
                       Centrifuge
             Distillation
             Column
                       New Chemical
                       Substance
                       Dnjrnmng
            SAMPLE PROCESSING OPERATION

   New Substance (500 kg/day)
1

(150kg/day)

(250 kg/day)

Diatomaceous >*









I

Rftar


i






   (Earth (100 kg/day)
                            DrunuranQ or
                            Packagng
  2. Occupational Exposure

    Column (1) - Describe each specific activity in the
    operation during which workers may be exposed to the
    new chemical substance   Such activities may include
    charging reactor vessels, sampling for quality control,
    transferring materials from one work area to another,
    drumming, bulk loading, changing filters, and cleaning
    equipment, etc.. Activities must be described even if
    workers wear protective equipment  (Material Safety
 Data Sheets indicating recommended protective
 equipment should be submitted as pan of Hazard
 Information in part I, section C, subsection 3 of the
 notice form)

 Column (2) • C8I claim for worker activity

 Column P) - Provide information on the specific types
 of protective equipment and englneenng controls that
 will be employed to protect the worker from potential
 exposure to the new chemical substance. I e, gloves,
 goggles, 2lc respirator, 19c respirator, closed
 containment system, nitrogen blanket, etc .

 Column (4) • Binding option for protective equipment
 and engineering controls.

 Column (5) - Indicate the physical form of the now
 substance at the time of exposure, e g , solid (crystals,
 granules, powder, dust), liquid (solution, paste,  slurry,
 emulsion, mist, spray), gas (vapor, fume), wet press
 cake, even if workers wear protective equipment

 Column (6) • Binding option for physical forms

 Column (7) - CBI claim for physical form.

 Column (B) - Estimate the maximum number of
workers involved in each specific activity, based on the
estimated maximum 12-month production volume

Column (B) • CBI claim.

Column (10) - Enter the maximum duration that any-
one worker will engage in  the activity in hours/day.
e g., 8 hours/day.

Column (11) - Enter the maximum duration that any
one worker will engage in  the activity in days/year,
eg., 200 days/year, based on the estimated maximum
production volume.

Column (12) • CBI claim.

Note that you must make  separate confidentiality
claims for the description of worker activity, physical
form of the new substance, number of workers
exposed, and duration of exposure.  (See  2, 7. 9. 12)
                                                       Column (1) - For each release point indicated m me
                                                       process description (Part II, Section A, subsection id(3)
                                                       of the notice form, enter the corresponding numtser

                                                       Column (2) • Estimate the amount of  new chemical (in
                                                       kg/day for continuous operations or kg/batch for  cute*
                                                       operations) that will be released from the release  pomt
                                                       directly into either (a) the environment or (b) mto
                                                       control technology (in kg/day or kg/batch)  Base your
                                                       estimate on the expected maximum twelve montn
                                                       production volume.
  Page 11
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                   CHEMICALS ON REPORTING RULES (CORR) DATABASE



RULE ODE,  CODE OF FEDERAL REGULATION (CFR), AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE
t60
NAME OF RULE OR PMN •
TSCA Stctlon 4
CITATION

FINAL
RULE
PUM.ISH
DATE

EFFEC-
TIVE
DATE

NOTES
EPA U proposing standards and crltarla It Intends
to UM in Interpreting Its Isgal authority to aaka
findings inter tha Twlc Substances Control Act
-------
 (OPTIONAL) POLLUTION PREVENTION AND RECYCLING
 INFORMATION (Page 11)

 This page requests optional information that will be used
 in the evaluation of the new chemical substance and a
 comparison of the relative nsks and benefits of the
 substance as a substitute for substances currently on the
 market  PMN submitters are encouraged to report any
 and all relevant information not reported elsewhere which
 is believed to be important to a thorough regulatory
 decision

 Part e^LST OF ATTACHMENTS  (Pegs) 12)
Attach any continuation sheets for sections of the
test data and other data (Including structure activity
information), and optional information after the last page
of the form.  CJearty Identify the attachment and the
section to which K relates. If appropriate.  Number
consecutively the pages of the attachments.  Enter the
inclusive page numbers of each attachment  Enter the
total number of pages in the notice on page  1 of the
form.

Mark (X) the 'Confidential' box  next to any attachment
name you claim as confidential. Read part I, section C.I
on page 2 of this manual for guidance on how to claim
any information in an attachment as confidential. You
must include with the sanitized  copy of the notice, a
sanitized version of any attachment in which you claim
information ae confidential.

A worksheet which assists EPA's review of the
physieai/chemiceJ property information you submit Is
provided on the last page of the fmni.  Providing
physical/chemical property infmiiislfon In tills format is
optional. However, physical/chemical properties data In
your possession or contiol must be) submitted with your
notice.  If you submit this worksheet,  kJeiilify K on the List
of,
Page 13
-------
                   CHEMICALS OH REPORTING RULES (CORR) DATABASE




RULE CODE, CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE


162










NAME OF RULE OR FUN 0



TMtlng Consult Agreement Development
for Acrylic Acid; Solicitation for
Interested Parties








40 CFR
CITATION


790.22










PRO-
POSED
RULE
DATE
8-20-91










PROPOSED
HUE FOR
CITATION

56 FR
4U51









FINAL
RULE FOR
CITATION












FIRAL
RUE
PUBLISH
DATE











EFFEC-
TIVE
DATE












NOTES



This notice serves three purposes under these
procedures. First It requests "Interested
persons" Mho wish to participate In tasting
negotiations for acrylic acid (CAS. No. 79-10-7)
to Identify thcswlvas to EPA. Second. It
announces a public abating to Initiate tasting
negotiations for this chaalcal. Third. It
proposes a target schedule for iapleoentatlon of
the consent agreement process. Submit written
notice to be designated an Interested psrty on or
before September S. 1991.
-------
    development activities must be conducted under
    tfw. supervision of a technically qualified
    individual  Persons who engage in R&O for. or
    obtain an R&D chemical from, a manufacturer
    must be notified of any nsk to health which may
    be aseorietert with the chemical.  However, R&D
    conducted entirely in laboratories under prudent
    laboratory practices are exempted from the
    requirement for nsk evaluation.

    m accordance with 40 CFR 720.78, the following
    R&O records must be retained: Information
    reviewed and evaluated to determine the need
    to make any notification of risk, documentation
    of the nature and method of risk notification,
    documentation of prudent lab practices used
    instead of nsk notification and evaluation and, if
    an R&O ftubstanoa is manufactured at greater
    than 100 hgs/yr. records regarding the chemical
    luoiiuty of lha substance to the extant ima*-..
    the production volume, and the disposition of
    the R&O chemical substance must also be
    retained.

    Manufacturers and importers who distribute an
    R&O substance to other persona must provide
    those persons with written notification of known
    hazard* and of the requirement that the
    substance be used solely for R&D.  For
    additional information on R&O requirement* see
    the New Chemical Information Bulletin:
Officer (TS-790)  You are not required but are
encouraged to use the PMN form for a TME
application
   Test Marketing available from the Environmental
   Assistance Division (see Section D. Part G of this
   manual for addresses and telephone numbers).
                           i (TIC) - You may
   apply for an exemption from premanufacture
   notification if you plan to manufacture or Import
   a new chemical substance for teat-marketing.
   Test-marketing Involve* the distribution of a
   prvowtOfrninoQ iKnitiid wnoufit of ft ctwcvwcu
   substance, or of a mixture or article containing
   the chemical substance, to specified number of
   customer* to explore market acceptability before
   general distribution.
   To approve a test-marketing
             . tile AQency muat make an
   affirm**** finding that the new chemical
   substance wfD not present an unreasonable nsk
   to heaNh or the environment during the test-
   marketing activities Section 720 .38 of the Rule
   IdentifkM the type of Information you should
   submit with a test-marketing exemption
   application.  EPA muat approve or deny the
   application within 45 day*. If you do not
   provide sufficient information for EPA to make
   its determination within 45 day*, the Agency will
   deny the, request

   You should send application* for test-marketing
   exemptions to the OTS Document Control
Section 50i)(4) ejusmpUcne - Under section
5(h)(4) of the Act, you may apply to EPA for an
exemption from some or all premanufacture
notification requirements.  EPA may grant an
exemption if K makes an affirmative finding that
the manufacture, processing, distribution in
commerce, use, or disposal of the new
substance will not present an unreasonable risk
to health or the environment  Unlike other
exemption*,  such a* test marketing, EPA may
only grant a  section 5(h)(4) exemption by rule.
In the rutomaldng proceeding, the applicant
should provide Information sufficient to show
that the chemical substance will not present an
unreasonable risk to health or the environment.
You sftauU send applications fcr sacticn Sf.JW
exemptions to the OTS Document Control
Officer (TS-790).  The following 5(h)(4)
exemptions have been promulgated:
         glume Coemption (LVE) - Requirement*
for  a LVE application are found at 40 CFR
723.50.  This exemption I* available for
substances manufactured in quantities of 1,000
kg or less per year.  Only one exemption is
available per substance regardless of potential
manufacturers.  Low volume substances are not
added to the TSCA Inventory; however, a
separate inventory of LVE* granted is
maintained.  The manufacturer must submit a
low volume exemption (LVE) notice to  EPA at
toast 21 days prior to manufacturing the
substance. The notice must include the site of
manufacture and proposed use of the new
chemical substance which are legally binding
upon the company.  The manufacturer may also
provide Information on exposure controls. V
provided, any control* specified In the  notice ere
binranQ tnrouQhout ttw period of ttie exemption.
EPA wM grant the LVE If M determine* that the
mbetteaiiOei VOT not pfw*wit *vi unfMsonsbw risk
of Injury.

Companies must submit a new exemption
notice before they change the stte of
manufacture or application.  Manufacturers
(Importers) must notify processor* and industrial
users that the substance can be used only for
the uses specifled In the exemption notice.
Manufacturers must also notify processor* and
user* of any exposure controls.

Under this exemption, submitters must maintain
record* for five years concerning the annual
production volume of the new substance,
documentation of Information provided in the
exemption notice, and compliance with the
term* of this section. See Section II (I).
15
-------
                   CHEMICALS ON REPORTING RULES (CORR)  DATABASE



RULE CODE. CODE OF FEDERAL REGULATION (CFR).  AND FEDERAL REGISTER (FR)  INFORMATION
RULE
CODE
Xl
•1
•1
Ml
•1
Kl
111
NAME OF RULE OR PMH •
Polychlorlnated Blphenyls (PCBo)
Manufacturing. Processing, snd
Distribution In Coeaerce. Stay of
Interpretation.
Polychlorlnsted llphenylt (PCBs)
Manufacturing, Processing, end
Distribution In Comerce
Polychlorlnated Blnhenyls In
Electrical Transformers; Correction
of Final Rule
Polychlorlnated Biphenyls; Criteria
•nd Procedures for Terminating
Storage and Disposal Approvals
Polychlorlnsted ttphenyls (PC8s);
Nanufacturing, Processing, and
Distribution In Comnerce, Partial
Rescission of Exemption Rule
Polychlorlnated llphenyls In
Electrical Transformers
i
1
Polychlorlnated Biphenyls (PCBs)
40 CFR
CITATION
761.20
761.80
761.30
22; 761
761.20
761
761.60
PRO-
POSED
MILE
DATE



11/2/90


8-31-90
PROPOSED
RULE FOR
CITATION



SS FR
46470


SS FR
35720
FIRM.
RUE FOR
CITATION
SS FR
S7714
SSF8
38998
SS Ft
45804

SS FR
46790
SS FR
49043

FINAL
RULE
PUBLISH
DATE
9/13/90
9-24-90
10/31/90

11/7/90
11/26/90

EFFEC-
TIVE
DATE
7/3/90
9-24-90
10/31/90

8/29/90
2/25/91

NOTES
This nolle* announces EPA's stay of an
Interpretation of 40 CFR 761.20(0(1) Mhlck MM
Included In the preamble to the PC8 Manufacturing,
Processing, and Distribution In Comwce Exemption
Rule (SS FR 21023).
Technical Amindsiint. Adds paragraphs for claat
exemptions and automatic renewals to CPA'a PCBs
Exemption Rulo (SS FR 21023) on Nay 22. 1990.
which Here Inadvertantly omitted In the codified
section of that nil*.
This action reinserts paragraphs (A). (B), and (C)
Inadvertently omitted from the final rule
published July 19. 1988 (53 FR 27322).
Proposed Rule: criteria and procedures for the
suspension or revocation of PCB storage and
disposal approvals under Section 6(o)(t) of TSCA.
This notice announces EPA's decision to rescind an
Interpretation of 40 CFR 761.20(0(1) which urn
published In SS FR 21023 In Nay 22. 1990.
Regarding requiring of exemptions for entitles
such aa EASA to buy and sell Intact, nen- leaking
PCB or PCR-contamlnated transformers.
Final Rule: mBonds Sections 6(0) of TSCA
concerning enhanced electrical protection
requirements for Ion volume radial transformers
containing Polychlorlnated blphenyls (PCBs). and
extends deadline for compliance.
Receipt of application for nationwide approval to
dispose of polychlorlneted blphenyls (PCBs) using
mobile solvent extraction/distillation systems.
Consents to be received by October 1, 1990.
-------
H.
          be directed to the Prenotice Coordinator
          Persons- may contact the Prenotioe Coordinator
          by telephone (202) 382-3745. Whiten inquiries
          may be sent to:
         Prenotioe Coordinator
         Chemical Control Division
         Office of Toxic Substances. TS-794
         U.S. EPA
         40i M Street. S.W.
         Washington, D.C. 20460
         During notice
                    •The notice review period
 begins upon receipt of the notice) by the OTS
 Document Control Officer If  your notice la
 determined to be 'complete*.  However, you will
 teceive written notification if your notice le
 declared Incomplete* as described at 40 CFR
 720 65.  if your notice is complete, you will
 receive an acknowledgement totter telling you
 your notice number and the date of expiration of
 the review period  The Inventory is searched to
 ensure that the substance for which the notice is
 submitted is not already included on the TSCA
 Chemical Substance Inventory. If your chemical
 substance is on the Inventory, you will be
 notified that your substance  la not subject to
 premanufacture notification,  and therefore you
 are free to begin manufacture Immediately.  V
 the substance is not on the Inventory,  a Program
 Manager is assigned to coordinate the review of
 the notice and to be your official contact with
 the Agency throughout trie review period.
 During the review period, the Program Manager
 may contact you for clarification of Information
 you have provided in the notice or H the Agency
 identifies issues of concern.  If you are not
 contacted prior to the expiration of trie review
 penod. you are free to commence manufacture
 of the substance Identified In your notice after
 the review period has expired.

 The Program Manager wiD also notify you before
the review period expires if he/she wU extend
the review period under TSCA section  5
         substance under TSCA section 5(e) or 5(f).  5(e)
         Consent Orders are typicafly Issued with a
         follow-up SNUR subsequently promulgated.   In
         addition, a Program Manager will contact you if
         the Agency plans to develop a noo-s(e) SNUR
         (a case In which a 5(e) Consent Order does not
         precede the development of a SNUR) on the
         chemical  substance Identified In your notice.
Notice of Commencement (NOG) of
Manufacture (or Import)
 expiration of the review penod. EPA requires that you
 notify the Agency by letter no later than 30 calendar days,
 after the first day of such manufacture or import.

 Your notice of commencement of manufacture should be
 sent to the OTS Document Control Officer (TS-730).  hi
 your letter, you must provide-the epecrfie chemical Identity
 of the substance. Its premanufacture notice number,  and
 the date when manufacture or Import began.  You must
 also substantiate a confidentiality dalm for chemical
 identity In your letter if you want EPA to maintain the
 dalm after you begin manufacture or import.  See 40 CFR
 720.85(b) for further Information on substantiating
 confidentiality claims.

 • you have submMed a NOC and you wish to be advised
 of the TSCA Chemical Substance Inventory name for the
 lubstanoe MentiBed In the NOC end tie Chemteei
                                                             Absaact Service (CAS) number (tor nan-confide
                                                             sttBBO eUDeMsWeOfleU Oj AeMsMMOe'l DUsTODaV fsl
                                                             number
                                                                        , you should send a separata totter to the OTS
                                                             Document Central Officer (18-790); Attention: Chemical
If EPA has not taken any action to regulate the new
chemical substance during the review period, you may
begin manufacturing the new chemical substance upon
Section 720.78 of the Premanufacture Notification Rule
requires that you retain documentation of information In
the premanufacture notice for five years from the date of
commencement of manufacture. The records you must
retain include (1) Information supporting the information
supplied on the notice form, (2) other data, as defined in
§ 720.50 (b) of the Rule. In your possession or control. (3)
production volume for the first three years of production
or Import, and documentation of production volume, and
(4) date of commencement of manufacture, and
documentation of this date.  For example, if you
performed a market analysis to estimate maximum
production volume as reported on the notice form, you
would retain tfria  analysis, even though production volume
and market sham may change. V you have performed a
chemical analysis to.determine what byproducts may
result from operations at sites you control, you would
retain that analysis. You an not required to develop
information solely for reoordkseping purposes, but only to
retain information you have obtained or developed in the
course of completing your submission.

If you manufacture a  new chemical substance under trie
exemption for substances manufactured solely for
research and development you must retain
documentation of compliance with the exemption for five
years from the Iras' date of manufacture or Import under
the exemption. If you manufacture under a test-marketing
exemption under TSCA, you must retain documentation  of
information hi the application and documentation of your
compliance with any restrictions imposed by EPA when It
granted the application.  You must retain this Information
for five years from the final date of manufacture or import
under the exemption.
Page 17
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                   CHEMICALS OH REPORTING RULES (CORR) DATABASE




RULE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR) INFORMATION
RULE
CODE


•6



HAKE OF RULE OR PNN «



Model Contractor Accreditation Plan;
Intent to Revise the Plan. Notice


40 CFR
CITATION


761



PRO-
POSED
RULE
DATE




PROPOSED
RULE FOR
CITATION





FINAL
RULE FOR
CITATUM

S6FR
HU9


FINAL
RULE
PUBLISH
DATE
1/29/91



EFFEC-
TIVE
DATE





NOTES



EPA announces Ita Intent to revise the Nodal
Accreditation Plan iftlch vaa laauad on April SO.
1987. pursuant to section 206 of the Asbestos
Naiard Ewroency Response Act (AHEM).
-------
                                                    APPBOXA
                                              EXAMPLES OF TEST DATA
 Following Is a list of the types of test data which you must attach to the notice form if tt Is In your possession or control.  This list
 Is illustrative, not exhaustive.

 Physical and Chemical
 Chromatograms
 Spectra (ultraviolet,
    visible, Infrared)
    density
Solubility in water
Melting temperature
Boiling/sublimation
    temperature
SofteninQ point
Vapor pressure
Di&soctation oonst&nt
Psftfcto size)
    QlStnDtltlOn
Octanol/water partition
Henry's law constant
Volatilization front
Volatilization from
    soil
PH
FlammabttHy
Explodability
Adsorption/desorption
    characteristics
Photochemical
    degradation
Viscosity
Odor
Hydrolysis
Thermal analysis
Chemical analysis
Chemical oxidation
Chemical reducuoji
Biodegradation
Transformation to
    or toxic product*
Mutagenterty
Cardnogenldty
Teratogenicity
Neurotoxicrty/
    behavioral effects
Pharmacological
Mammalian absorption
Distribution
Metabolism and
    excretion
Cumulative, additive
    and synerglstic
Acute, subchronte
    and chronic effects
Strxxrture/activrty
RSpCOGUCtlW STTSCtS
OlnlceJ studies
PhototoxWty
SensrUzation
AJIergy
Skin staining
Mterobial bloassay
Algal bloassay
Aquatic macrophyte
    bwaasay
Seed germination and
    root elongation
Seedling growth
    Inhibition
Plant uptake
Acute toxldty to
    Invertebrates
Life cycle test on
Acute toxldty to
    fish
Early life stage
    (Hah)
Avian dietary/
    reproduction
Btoaceumulation/
           miration
                                             Model ecosysts
Physical environment
    Impairment effects
Flesh staining of
    aquatic organisms
      19
-------
                   CHEMICALS ON REPORTING RUIES <(I*QI  i ».> >




RULE CODE. CODE OF FEDERAL REGULATION (CFR). AND FEDERAL RECISIER OR)
RULE
CODE
«7
x7
x7
NAME OF RULE OR PNN 0
Receipt of Requests for Exclusion
From TMtlng Fro* Three Chemical
Companies. Notice of Receipt.
PrapMtd Regulation of land
Application of Sludge Fro* Pulp and
Paper Ml lie Itelng Chlorine and
Chlorine Derivative Iteachlng
Processes. Proposed rule; ex tens Ion
of cement period and announcement of
public hearing.
Proposed Regulation of land
Application of Sludge Fraa Pulp and
Paper Nil la Using Chlorine and
Chlorine Derivative R leach Ing
Processes. Proposed rule; notice of
meeting.
40 CFR
CITATION
766
744
744
PRO-
POSED
RULE
DATE
7/15/91
8/8/91
9/20/91
PROPOSED
RULE FOR
CITATION
56 FR
52208
56 FR
37686
56 FR
47717
FINAL
RULE FOR
CITATION



FINAL
RULE
PUBLISH
DATE



EFFEC-
TIVE
DATE



NOTES
EPA requires that specified chssilcal substances be
taated to dtteralne If they are contaminated with
halogenated dlbenio-p-dloilne (NDOs), or
halogenated dlbsniofurans CRDFa). and that results
be reported to EPA. However, provisions are Bade
for exclusion fro* these requirements If an
appropriate application la submitted to EPA and Is
approved. Submit written comments on or before
July SO. 1991.
Notice la hereby given that the period for filing
public comment on the proposed rule for Land
Application of Sludge from Paper Hills Using
Chlorine and Chlorine-Derivative Bleaching
Processes Is extended, and that an Informal public
hearing on the proposed rula will bo held. Public
commenta must be received on or before September
17. 1991. The Informal public hearing will begin
on October 29. 1991.
Notice la hereby given that • peer review panel
will wet to evaluate the risk assessaanta
underlying the proposed regulation of land
application of sludge from pulp and paper mil la
using chlorine and chlorine derivative bleaching
processes. The pear review panel will mmet on
October 1 and 2. 1991.
-------
                                                                            Form Approved. O.M.& No. 2070-OOH Approvil Expires 1-31-94.
                u. S.TENVBRONMENTAL PROTECTION AGENCY
                         PREMANUFACTURE
                                NOTICE

                    FOR NEW CHEMICAL SUBSTANCES
                         DOCUMENT CONTROL OFFICER
                         OFFICE OF TOXIC SUBSTANCES, TS-790
                         U.S. EJ»A.
                         401M STREET, SW
                         WASHINGTON. D.C 20460    	
Enter the total number of pages
in the Premanuf acture Notice
                                                                                        AGENCY USE ONLY
          Date of receipt
                                                                                                  EPA cue number
                                         GENERAL INSTRUCTIONS
                           TS-UUUUUU
     •Yon must provide all information requested In mis form to the extent that it b known to or reasonably aseertaliuW* by you.
      Make reasonableestima test* yon do not have actual data.
     • Before you complete thi» form, yon should read (he Instruction* Manual for Premanufactnre Notiflcatioir flnsiiucUum Manual).
     • If a user fee has been remitted for this notice (40 CFR 700.45), indicate in the TS boxes above the TS-oser fee identification
      number yon have generated. Remember, your nser fee ID number mast also appear oa your corresponding fee remittance.
   Part I - GENERAL INFORMATION

   Yoa nut prorMc Ike chearical ideality of tkt aewckarical
   nb*taBcc,evea If roa data tke Meatfly at omfUcatial. YoaBMV
   authorize meAtt penoa to nbait tfce UtmUtf focvoa, bat jomt
   labatakm will sat be omplcte awl icvlew wiU aot begto matfi
   EPA receives tkia iafonaatioa. A letter of sapport frost aaolher
   persoa iboaM icfaocejromr TS i
                              i ft* Una/bottom mubet
   Fart 0 - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

   Yoi sur Med addiUoui ooptes of put IL sectkm A awl B If tken
   at several sunfactaie, ptmasiig, or «• offuitomt thjt VOB win
                    Ymnkoddicpradvcetkesc section as seeded.
TEST DATA AND OTHER DATA

Yoa an nqataed to sabsjlt all test data ta roar poaacasloa or cmtni
•ad to provide a docripttoa of all other data kmowm to or namae-ly

rtTinaanratil rffirtt Trf fir -mTr-—. |	'-f. -"-»-"-"—  '"-'
tBO>suktree,BM,ardispoaaloftW»ew<*esricati«b«a»ce. StaadanJ
tttenran dtottras aujr be sabviHed for data i» OM opea ideatifk
Utcratan. Coaipleto test data (wdHss !• Es«Usk), aot saauurie* or data,
HBBtbetabstMtedlftberdoaat appear la tha opea Uarataie. FoOowiag
an eusxpie* of tost data akdotkar data, Yoa shoald sahaUt tkcat
data aaoordiag to th* naatasMato of §7JOJO of the Preauaafactan
NotiflcaUea Rale (40 CFR Part ntt.
                                                               TcstData
   Put m - LIST OF ATTACHMENTS

   YoBikimU sttack addiboBal sheets If voa do aat have esmigh sp«cs
   OB Ue font to aaswer a qiestta hUJy. Label eack arattmaanasi sheet
   wtUlheconcsposdlagfeclfaabeadUt,  la put OL IM tkeas sHadks»eals,
   tay lest data or other data ud mj optioul ImfonMtioa tkat yo« imdao*
   OPTIONAL INFORMATION
                                      tfcat voa wart EPA to
   Yo« nay l«d«de (• Uw •oUee t«y
   comsideriaevalMtJagthcaewsabataBce,
   IdeaUfies calcgoria of opUoul Imforauttos that yo« stay wast EPA to
   trrlew. Oa page 11 of tkis forav spaa hat ban pnxrtded te ytm to
   dcstribc poJJ«Uo« pirvemttoa *»d racrdteg fafeaudaa 70* BUT aav*
   regjidlag th« MW s»hrt»r»
   Binding Option* U order to sffsttHeh'tiq>

  Q POLYMER EXEMPTION- DeO)  or LJeO)

  CJ OTHER EXEMPTION - SPECIFY V
EPA FORM 7710-25   (Rev. 1-91)
                   Replaces previous editions of EPA Form 7710-25.

                                       Printrt OH f^crdfd Paper
-------
                   CHEMICALS ON REPORTING RULES (CORR) DATABASE




RULE CODE, CODE OF FEDERAL REGULATION (CFR). AND FEDERAL REGISTER (FR> INFORMATION
RULE
CODE
RlO
NAME OF RULE OR PNN f
Propoaed Ben on AcryloBlde and N-
Mthylolocrylaoilde Grouts. Notice of
proposed ruleaaklng.
40 CFR
CITATION
764.125
PRO-
POSED
RULE
DATE
10/2/91
PROPOSED
RULE FOR
CITATION
56 FR
49863
FINAL
RULE FOR
CITATION

FINAL
RULE
PUBLISH
DATE

EFFEC-
TIVE
DATE

NOTES
Thla proposed rule would prohibit rh» manufacture.
taportatlon, distribution In cosmrce. and use of
ecrylaeJdo grout; end Mould prohibit all uses of
N-e*thylolecryla*lde (NNA) grout, except Ita use
for sewer line repair. Written requests to
participate In the Inforaal hearing euat be
received by December 2. 1991.
-------
     notice form, including attachments, which does not
     contain confidential Information. This 'sanitized'
     version will be placed In the public file.  It must
     contain all non-confidential information. Including
     health and safety studies.  If you do not provide the
     sanitized copy with your submission, the submission
     will be incomplete and the review period will not
     begin. If you provide a subsequent amendment to
     your PMN or additional information/data, you must
     also provide a non-confidential version tor the public
     file.

     2. Substantiating claims

     You are not required  to provide substantiation of any
     confidentiality daim when you submit your notice.
     However, you must substantiate your daim of
     confidentiality for chemical identity at the time you
     submit a notice of commencement of manufacture, if
     you want EPA to maintain your confidentiality daim
     after you begin manufacture.  To substantial* that
     daim. you must provide EPA with detailed answers
     to the questions which appear in the PremanufecUiro
     Notification Rule (§ 720.85(b)(3)0v)). This
     substantiation must accompany your notice of
     commencement You may be required to
     substantiate other confidentiality claims If EPA
     receives a Freedom of Information Act request on
     that Information.
During the course of its review, the Agency will be
considenng whether the activities surrounding the
manufacture, processing, use, and disposal of the
substance Identified in the notice may present an
unreasonable risk of injury to human health or the
environment. Control measures instituted by the
submitter to reduce exposures and/or releases of the
substance may have a direct bearing on the Agency's
conclusions regarding risk.  Therefore, you may wish to
indicate your willingness to be bound to certain
information you have submitted on this form which may
be related to the issue of potential risk such as use.
production volume. protective equipment engineering
controls, and/or process description.  By providing this
information,  you would be Indicating an interest In future
negotiations if the Agency deems them necessary.  In
order to make your intentions known to EPA, mark (X)  in
the 'Binding Option* box on the form located to the right
of tne appropriate information. The purpose of the
binding option is to enable EPA (if necessary) to efficiently
negotiate with the submitter the development of section
5(e) consent orders and promulgate Significant New Use
Rules (SNURs) for those new chemical substances that the
Agency determines may present an unreasonable risk if
certain control actions are not implemented. This option
is intended to reduce delays that.routinely accompany the
development of consent orders under the current process.

Should the Agency wish to discuss your intention, you will
be contacted by a Program Manager and negotiations
may ensue. Therefore, indicating a willingness to be
bound by the terms of your notice does not by itself
prohibit the submitter from deviating  from the information
(except chemical identity) reported in the form.

The Agency ia interested in obtaining ajj information
relevant to making the appropriata regulatory decision
during the course of a (new) chemical review.  It ia
irppertert Ihst EPA acquire :r.forrr.sticn  rcyaralng 
-------
                                         Part I - GENERAL INFORMATION
    Section A - SUBMITTER IDENTIFICATION
                          Mark 00 the "Confidential" box next to any subsection you claim as confidential
      Person
      Submitting ^^
      Notice     ~~*
      (in US.)
                   Name of authorized of fioal
 Company
                   Mailing address (number and street)
                   Gty, Slate. ZIP Code
  b.  Agent (if
     applicable)
                   Name of authorized official
                   Company
                   Mailing address (number and street)
dry. State, ZIP Code
i
I 	
Telephone (
I
i
Area Code j Number
I .
I
I
   c If you are submitting this notice as port of a joint submission, mark 00 this box.
    Joint
    Submitter
   Of applicable)
Name of authorized of fldal
                  Coniputy
                  Mailing address (number and street)
                 City. Slate, ZIP Code
  2. Technical    ^anf
     Contact
                 Company
                 Mailing address (number and street)
                 City, State, ZIP Code
3  If you have had a prenotiOB communication (PQ concerning mis notice
   and EPA assigned a PC Number to the notice, enter the number.
                                                                       Mark 00
                                                                       if i
                                                                  n
4.  If you have submitted an exemption notice/application for
   the chemical substance covered by this notice, enter the exemp
   number assigned by EPA. If you have withdrawn a previously
   submitted PMN enter the PMN number.
                                                                       Mark (X)
                                                                       If none
5.  if you have submitted a bonafide request for the chemical substance
   covered by this notice, enter the bona fide request number assigned
   by EPA.
                                                                       Mark 00
                                                                       if none
    ype of Notice-Mark 00
                                     1.
                       I    I  Manufacture

                       n
Only

Binding Option
Mark(x)
2   I    I  Import
z-   I	1  Only

          nBfnctingOption
          Mark(x)
                                                                                                          n
Both
 FORM EPA 7710-25   (Rev. 1-91)
                                       Page3
-------
G.  Completing the Parts of the totka Farm

Part I - GENERAL NFORMATON

S0dlon A • Submrttsr kJantiflcalion  (Pips 3}

la.  Person submitting notice • EntBf inform&tion on the
     official who signed the general certification.

 b.   Agent - Complete  only if you authorize an agent to
     assist you in preparing this notice.  The agent must
     also sign the certification as noted above.

     » ysu rraft (XJ the •ConfidsPtW So« n«rt to -terns a
     or b. all information in the item will be treated as
     confidential.

 c.   Mark (X) the box if your submission Is a Joint
     submission.  Identify In Part I. Section A (1)(c) the
     name of the joint submitter who is authorised by the
     U.S. submitter to provide some of the Information
     required in the notice*  For additional infufiiiation on
    joint submissions,  see part II, section F of this
     Manual  A notice will not be considered complete
    until a.; information is received by the Agency.  If
     information f^^nb multiple   rties win not be sent
    together, use your TS-Uso  J Number to link
    multiple notices.

     Mark PQ the •Confidential* box next to Hem e If you
    wish this information to be treated as confidential.

     If you  authorize another person (e.g.. a foreign
    manufacturer or supplier) to provide information,
    such as, confidentially held tradename chemical
    substance identification directly to EPA, Indicate
    which information  will be supplied by the other
    person.  Identify that person by name, company, and
    address in a continuation yieet That person's
    identity may be claimed as confidential. Such a
    letter In support of your notice should be provided by
    the other person on company letterhead.  A notice
    will be considered Incomplete until this Information is
    provided.  Whenever possible use your TS-User
     Identification Number to link this Information.

2.    Technical contact • Identify a person who can provide
     EPA with additional Information on  the new chemical
    substance during the notice review period. The
    technical contact identified should be located In the
     United States and  be available to be reached by
    telephone  during normal business hours.  If you
     mark (X) the 'Confidential' box next to this
     subsection, all information in it will be treated as
     confidential.
      '•ovide any prenctic* communication'slumber
      Assigned to your orenotlce inquiry.  In addition, see
      Section II. Part E of this manual for further
      information on submission of a consolidated PMN
      that requires a prenotice consultation.

      Provide the exemption number assigned for any
      previous exemption application submitted for the
      chemical substance covered by this notice.  Also.
      provide any previously assigned PMN number, If
      any, for the chemical substance.

      Self-explanatory.

      Mark PQ to indicate whether you intend to
      manufacture or import the new chemical substance
      or both manufacture and import.  Use the optional
      binding box to Indicate your willingness to be
      bound to either import or domestic manufacture
      only.
       B-
EPA must i
          > and unambiguous
Identification of the new chemical substance. If the
substance Is not adequately Identified, the submission win
not meet statutory reojulrementB and the mrttoe review
period wiO not begin. If a principal importer does not
know the specific Identity of the new substance, the
submitter musr jonlact the foreign manufacturer or
supplier and have the specific chemical Identity
information  required In the PMN provided directly to EPA.
In this way,  foreign manufacturers can protect confidential
business information. The same holds true for U.S.
    ufactu
sporting chemical substances using a
generic or trade name to Identify a component of the new
chemical substance.  The submitter of the new chemir
substance must have the supplier provide chemical
Identity Information directly to EPA before the notice can
be considered complete. This Information may be
provided in a letter of support from the supplier or as a
joint submission. A totter of support should be provided
on the supplier's corrsany letterhead.  See Part II. Section
F(2) of this  manual en row and when to file a joint
submission. Since a .aner of support or a joint
submission may be received separately by the Agency, an
identification number such as a TS-user fee number or a
Prenotice Communications number should be used to link
a PMN with information from a supplier or foreign
manufacturer.  The identical Identification number should
appear on botr. pieces of correspondence submitted to
EPA; otherwise  there may be a delay In processing the
PMN.

The type of chemical identity Information required in the
notice depends on whether the substance Is a Class 1 or
-------
Part I - GENERAL INFORMATION - Continued
^ Section B - CHEMICAL IDENTITY INFORMATION - Continued
Polymers (For a definition of polymer, see the Instructions Manual)
i. Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture.
Indicate maximum weight percent of low molecular weight species (not Including residual monomers, reactants, or solvents) below
500 and below 1 ,000 absolute molecular weight of that compaction. Describe me methods of measurement or the bases for your
estimate*. GPC || Oner || (Specify)
- lowest number average molecular weight:
- maximum weight % below 500 molecular weight:
- maximum weight % below 1000 molecular weight:
LJ Mark 00 this box if you attach a continuation sheet

b. You must make separate confidentiality claims for monomer or other reactant identit
information. Mark 00 the "Confidential" box next to any item you daim as confident
(1) - Provide the chemical name and CAS Registry Number of each monomer or oth
(2) - Mark 00 this column if entry in column (1) is confidential.
\3j — uioicaw Jie typical wtagnt percent 01 eacn monomer or outer reactant in tne pa
(4) - Mark UO the identity column If you want a monomer or other reactant used a
polymer description on the TSCA Chemical Substance Inventory.
(5) - Mark 00 this column if entries in columns Q) and (4) are confidential
(6) - Indicate the maximum weight percent of each monomer or other reactant mat i
manufactured for commercial purposes.
(7) - Mark 00 this column if entry in column (6) la confidenaaL
Monomer or other reactant and CAS Registry Number
C1)

-




>
\ 	 | Mark 00 this box if you attach a continuation sheet
c. Provide a representative sfructund diagram of the polymer. If possible.
1 1 Mark 00 this box if you attach a continuation sheet
Confi-
dential
(2)










', composition
aL
er reactant use
lymer.
t two weight |
naybepnaen
Typical
ootnpoBitiofi
C3)
J
%
%
%
%
%
%





Confi-
dential


information, and residual
d in the manufacture of the polymer.
wrcent or lea* o> be il«cu •» part of Uit
t as a residual in the polymer as
Identity
Mark(X)
(4)









Confi-
dential
(5)







Maximum
residual •
(6)
%
%
%
%
%
%
- *
1

|

Confi-
dential
(7)
•





mm

FORM EPA 7710-25 (Rev. 1-91)
                                                        PageS
-------
         describe the nature of the reaction or process.
         A description should appear in the form of a
         reaction scheme:
    A + B
                           ->  C
         The nature of the reaction must be described as
         specifically as possible (e.g.. acetylatlon. alkaline
         hydrolysis, dlazottzation).  For substances that
         have been produced without chemical reaction
         (e.Q.. by chemical extraction Irom a natural
         source), specify the source, tfie production
         process, and the nature of the product

     (3)  If you Intend to  manufacture a Ctass 2 chemical
         substance within a limited range of possible
         compositions, report the range.  For example, a
         manufacturer filing a notice for chlorinated
         naphthalene might specify a oompoaWonal
         range of 20*40 percent chlorine by weight hi
         determining the range, you may have to
         consider the reaction conditions, the catalyst, or
         the purificatlofi procesa that may be used to
         produce the substance, and other factors.  You
    should provide the range of
    weight percent for each spac
                                      position in
                                      component or
             i of components that you intend to
         manufacture for commercial purposes.  Indicate
         the typical composition or any actual values for
     (4)  Provide as complete a structural diagram as
         possible. The diagram should indicate the
         characteristic structure or variable compositional
         elements of the substance.
2. Polymer*   (PageS)
  a. Indicate the lowest numfe
                                         t weight
     of any composition of the polymer you intend to
     manufacture*  Identify the method you ueod to make
     this determination (a.g.. vapor pressure oamomatry
     or olhor colflgatiVe property datanTHAsborta, gal*
     permeation cruoivuw^fafHiyi HQUI acaoannOft or
     various correlative techniques).  V you have not
determined nun
analytical rnefhi
                                           ight by
                   de. briefly explain the basis for your
     estimate, (ncttoala tfia nwurnurn weight pafoant of

     1.000 absolute molecular weight  Include the weight
     of ollgonieric reaction producta including moleculei
     formed that are not polymer molecules) In your
     determination but do not Include the weight of
     residual monomers or other reactanta.  Attach test
     data supporting your estimate.  If you do not have
     actual test data, provide an estimate and describe
     the  basis for the estimate.
Column (1) • Provide the chemical name and CAS
Registry Number of each reectant used in the
manufacture of the polymer. Including those used at
2 weight percent or less. Reactanta include
monomers, free radical initiators, and cross-4inMng,
chain transfer, and other reactive agents that are
used intentionally to become chemically a part of
the polymer composition. If prepolymer Is used in
the manufacture of the polymer, list the prepolymer
in terms of Ka. component reactanta.  Identify by
bracketing or another method that the monomers
are oomponenta of a preporymer.

Column (2) • C8I daim.

Column (3) - for sacn reactant (Including
monomers), indicate Ha typical weight percent in the
polymer. The wekjfit percent of a reactant la the
weight of the rosotant charged to  the reactor
divided by the weight of the polymeric chemical
manufactured (timea 100).  Thus, the weight percent
of nMctant A of a polymer manufactured from
reactanta A, B, and C la the weight of A charged to
me reactor divided by the dry weight of the polymer
A-B-C (tones 100).

If you use a prepolymer In the manufacture of the
polymer, you must determine the  weight percent of
Its component reactanta. For example, the weight
percent of E used in the manufacture of a polymer
^••^M •AAj^AMftM A D  »ntt ^ AMjd r\tmn nil MM* mr O-B I*
from reauaiR. ^ D,  ano \* ano preporymer u*c is
the total weight of monomer E in  the prepolymer D-
E used divided by the weight of the polymer A-B-C-
O-6 manufactured (times 100).  You must provide
the Identity and typical weight percent of each
monomer and other reactant used in the
manufacture of the. polymer regardless of the weight
percent at which tt la used,  if you will typically
manufacture the polymer using a reactant in a
range of weight composition, you may Indicate the
range of weight percent Instead of the typical
weight percent.

Column (4). Rsactants used at greater than  2
weight percent In the manufacture of the polymer
are Included as part of the description of thv
polymer Hated on the TSCA Chemical Substance
Inventory. However, you may choose whether or
not to include reactants used at 2 weight percent or
less in the Inventory description of the polymer.

Mark (X) the Identity column if you want a reactant
present at 2 weight percent or less to be Included In
the description of the polymer which is added to the
Inventory.
Pagse
-------
                    - - -  Part I  - GENERAL INFORMATION - Continued
  Section C - PRODUCTION, IMPORT, AND USE INFORMATION
                            Marie (X) the 'Confidential' box next to any item you claim as confidential
1. Production volume - I
   the maximum production volume for any consecutive 12-month period i
	MaM>fHiin first 12-monih production Qcgy vri
  ig me first three years of production.

                             fVv/vrt
                                                                                                             Confi-
                                                                                                             dential
                                                                    Bhtdlas.
                                                                    Optic.
                                                                    Mokb)
2. UM Infonution — You must make separate confidentiality claims for the description of the category of use, the percent of production volume
   devoted to each category, me formulation of the new substance, and other use information.  Mark 00 the 'Confidential* Box next to any (ten you
   claim as confidential
  a. (1) - Describe each Intended category of use of the new chemical substance by function and application.
    (2) - Mark (X) this column if entry in column (1) to confidential business information (CBD.
    (3) - Indicate your willingness to have the information provided in column 0) binding.
    (4) - Estimate the percent of total production for the first three years devoted to each category of use.
    (5) - Mark (X) this column if entry in column (4) to confidential business information (CBO.
    (.6) - Estimate the percent of the new substance as formulated in mixtures, suspensions, emuMons, solutions, or gels as manufactured
        tor cutntiienddl pupates dt sites under your ccnirct cssocisted with each category of use.
    (7) - Mark (X) this column if entry in column (6) to confidential business information (CBO.
    (8) - Mark (X) whether the use is site-limited, industrial, commercial and/or consumer. Mark more than one box if appropriate.'Mark
        (X) to indicate your willingness to have the information provided hi (8) binding.
    (9) - Mark (X) this column if entrvOes) in column (8) to (are) confidential business information (CBD.
                Category of use

                     (1)
CB1

Q)
                                                        MMkta)

                                                          Q)
Produc-
tion %

  (4)
CBI

(S)
%m
Form*
ulation
  (O
CBI


 (7)
                                                                                             Mark 00 appropriate column(s)
                                                                                                        (8)
Site-
       Con-'
             Indus-
             Wai
Com-
merdal
Binding
Option
CBI


 (9)
 •If you have identified a "consumer" use, please provide on • continuatkm sheet a detailed deacription of the use(s) of this
 chemical substance in consumer producta. In addition include estimates of the concentration of the new chemical substance as
 expected in consumer products and describe the chemical reactknu by which uu^»ubr4ance loses ta identity in the consuoier
 product.

 D Mark (X) this bc« if you an^ a ccnttonalion sheet	
  b. Generic          " youdata any category of use description in subsection 2a as confidential enter a generic description of that
    im              category. Read the Instructions Maraal for examples of fleneric use desonptionai
    use
    description
    Mark (X) this box if you attach a continuation sheet
I. Hazard Information - Include in the notice a copy of reasonable facsimile of any hazard warning statement label material safety data sheet,
  or other information which will be provided to any person who Is reasonably likely to be exposed to this substance regarding protective
  equipment or practices for the safe handling, transport, use, or disposal of the new substance. List in part m hazard information you mdude.
D Mark (X) this box if you attach hazard information.
                                                                      Opdo.
                                                                      MokCO
FORM EPA 7710-25   (Rev. 1-91)
           Page 7
-------
  name should reveal the chemical identity of the
  substance to the maximum extent possible.  Guidelines
  for developing a generic name are provided in
  Appendix B of the TSCA Chemical Substance Inventory.
  Volume 1. The generic name will be published In the
  FEDERAL REGISTER notice on the new substance.
  EPA will review the adequacy of the generic chemical
  name when the notice of commencement of
  manufacture of the substance Is submitted. If the
  name seems more generic than necessary. EPA will
  contact you to develop an adequate name.

7. Byproducts • List the byproducts that you reasonably
  anticipate will result from the manufacture, processing.
  use. and disposal of the new chemical substance at
  sites you control, (dentify the byproducts as specifically
  as possible by name and CAS Registry Number (H
  available). You should give the following information:
  (1)  the specific chemical name! or

  (2)  a class or range, of structures (e.g., Cg - CM fatty
       acid salts or porychtorinatsd cycDc and acyclic
       hydrocarbons In the range Cg - Crf; or
  (3)  the source (e.g.. pyrorysis products of ceHutose or
       coal tar residues). If them are no byproducts,
hnpoit&UM
Section C-
 . Production volume • Estimate the maximum production
  volume for the first 12 months of production. Also
  estimate the maximum production volume for any
  consecutive 12-month period during the first 3 years of
  manufacture. Provide your estimates In kOognms.
  Maximum production volume is the maximum amount
  of the new chemical substance you expect to produce
  over a one-year period (e.g.. June 1990 through May
  1991). Include In this total amounts produced by
  persons under contract to you. If part of the amount
  manufactured Is for export. Include Ms amount In your
  estimates.  (You are not allowed to exclude amounts
  once the substance la no longer manufactured soMy
  for export)

  Ito information

  a.   Column (1)  Identify the Intended category of use
       of the new chemical substance by describing its
       function snd
       •Function* is related to the Inherent physical and
       chemical properties of the substance (e.g.,
       degreaser, catalyst, plasttcber. ultraviolet
       absorber).  'Application' refers to the use of the
                                          substance in particular processes or products (e.g.. a
                                          degreaser may be used for cleaning of fabricated metal
                                          parts).

                                          Following are some examples of how you should
                                          describe categories of use:
                                          0  a disperse dye curler for finishing polyester fibers
                                          •  a cross-linking agent for epoxy-type coatings for
                                             metal surfaces
                                          •  a flame retardant for surface application on cotton
                                             apparel, textile home furnishings, and exterior
                                             canvas products
                                             a surfactant in automobile spray wax
                                             a colorant for paper and other eellutoslcs
                                             fiber-reactive dye tor nykm carping and
                                             an anttoxidant In fuels oils and lubricants
                                          Column (2) CBIdalm.

                                          Column (3) Binding option for category of use.
                                                  (4) Estimate the percent of the total
                                                     ohjmo that you anticipate win be
  productioi
  manufactured for each category of use.

  Column (5) CBIdalm.

  Column (B) Estimate the weight percent of the new
  chemical substance that win be contained in any
  formulated rnbdure, suspension, emuWon. solution, or
  gel associated with each category of use as
                                          manufactured for commercial purposss at sites under
                                          your control. Where the substance Is distributed from
                                          your site neat, enter N/A (for not applicable).

                                          For example, a PMN substance will be used for several
                                          different uses, including a eross-JInldng  agent where the
                                          substance is distributed neat and as a surfactant where
                                          the substance is present in the formulation at a weight
                                          percent of 4.  Bghly percent of the production  volume
                                          encompasses the first use and twenty percent of the
                                          production volume win be used for the  second  use.
                                        Category C8I  Binding  Production  CB Percent In  CBI
           ____
1. Cress-  X    80%
                                                       20%
                                                                               NA
ZSur-
factafit in
autofnottla
spray wax
-------
           Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
   Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER - Continued
   Occupational Exposore - You mutt nuke separate confidentiality daims for the description of worker activity, physical form of the new chemical
   nibstance, number erf worker* exposed, and duration of activity. Mark (X) the •Confidential* box next to any item you dalm as confidential.
   1) - Describe the activities ta which workers may be exposed to the new chemical substance.
  a) - Mark (X) this mlumn if calrym column (1) la confidential business information (CBD.
  (3) - Describe any protective equipment and engineering controls used to protect workers.
  (4) and (6) - Indicate you wUHngnesa to have the information provided in column (3) or (5) binding.
  (5) -Indicate the physkal form(s) of the new chemical substance at the lime of exposure.
  (7)- Mark (X) this column If entry in column (5) Is confidential business information (CBD.
  (8) - Estimate the maximum number of workers involved In each activity.
  (9)- Mark °(X) this column if entry in column (8) Is confidential business information (CBI).
 (10) and (11) - Estimate the maximum duration of the activity for any worker in hours per day and days per year.
 (12) -Mark 00 this column If entries in columns (10) and (11) are confidential business information (CBl).
           Worker activity

                0)
                              CBI

                               Q)
EijuipDicnt/
^ CoDtraiB
0)	
(4)
      Physical
      fonrKs)
Btadia«
OpMo.
ktakb)
  (6)
CBI

 (7)
 • of
Workers
CBI

(9)
                                                                                                         Maximum duration
              Mrs/day
                 (10)
Days/yr
  (11)
CBI

(12)
  |   | Mark (X) this box if you attach a continuation sheet
     Environmental Release and Disposal- You must make separate confidentiality claims for the release number and the amount at the new
                                                          nation. Mark (X) the •Confidential* boot next to each item you data as
                                                                                    A. subsection ld(3).
chemical substance released and other release and ^*f«""j Information.
confidential.
(1) - Enter the number of each release point identified in the process description, part D,	.	_..
(2) - Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology On kg/day or kg/batch).
(3) - Mark (X) this column if entries in columns fl)«nd CD are confkiential bustaess mfbrmation (CBD.
(4) - Identify the media (air. bnd. or water) to which the new substance wffl be released from that release point
(5) - a. Describe control technology, if any, ^nd control efficiency mat will be used to Undt the tdeasectf the new substance to the environmenL
     For releases disposed of on land, characterize the disposal method and state wnetherU ta approved for disposal of RCRA hazardous waste.
     On a continuation sheet .for each site describe any additional disposal methods that will be used and whether the waste is subject to
     secondary or tertiary onrfltte treatment  o. FnilimtB ttte mount released to the environment after control l^nflnology un kg/day).
(6) - Mark (X) this oohmw if entries mcc4umns (4) arid (5) are confkiential business informal
(7) - Identify the destination(s) of releases to water.  plaMa •"TT'r *"*"** (N-**"-"' P«nm«t nu^.«^j. m^t**^ Sy«t«m> mimhp>. h» MT~+
     ctischargersccNFDESnumbenc
-------
               OPTIONAL POLLUTION  PREVENTION INFORMATION
  To claim information in this section as confidential circle or bracket the specific information that you claim as confidential.

  i this section you may provide information not reported elsewhere in this form regarding your
efforts to reduce or minimize potential risks associated with activities surrounding
manufacturing, processing, use and disposal of the PMN substance. Please include new
information pertinent to pollution prevention, including source reduction, recycling activities
and safer processes or products available due to the new chemical substance. Source reduction
includes the reduction in the amount or toxicity of chemical wastes by technological
modification, process and procedure modification, product reformulation, raw materials
substitution, and /or inventory control.  Recycling refers to the reclamation of useful chemical
components from wastes that would otherwise be treated or released as air emissions or water
discharges, or land disposal. Descriptions of pollution prevention, source reduction and
recycling should emphasize potential risk reduction subsequent to compliance with existing
regulatory requirements and can be either quantitative or qualitative.  The EPA is interested in
this information to assess overall net reductions in toxicity or environmental releases and
exposures, not the shifting of risks to other environmental media or non-environmental areas
(e.g., occupational or consumer exposure). In addition, information on the relative cost or
performance characteristics of the PMN substance to potential alternatives'may be provided.
All information provided in this section will be taken into consideration during  the review^.
of this substance.	"
Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in
the volume manufactured; (3) a reduction in the generation of waste materials through recycling, source reduction or other -
means; (4) a reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product
  rformance, a decrease in the cost of production and/or improved operation efficiency of the new chemical substance in
  mparison to existing chemical substances used in similar applications; or (6) the extent to which the new chemical substance
  ly be a substitute for an existing substance that poses a greater overall risk to human health or the environment	
   Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25   OUv. 1-91)
                                         Page 11
-------
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET
To assist EPA's review of physical and chcmfcal properties data, please complete the followt
and Indude it In the notice. Identify the property measured, the page of the notice on which
of the property, the units In which the property Is measured (as necessary), and whether or i
confidential. You are not required to submit thb worksheet; however, EPA strongly recomn
review and ensure that confidential information is properly protected. You should submit tl
your submission of test data. This worksheet is not a substitute for submission of test data.
Property
(a)
Vaporpressure qp

Density/relative density
Solubility oc
-------
   Column (7) CBI claim.

   Column (8) Marie (X) to indicate If the category of use
   is site-limited or whether the substance Is Intended for
   industrial, commercial, and/or consumer use, as
   defined below.

   SrMimMsd • The substance will be used only on the
   contiguous property unit where tt Is manufactured  and
   not intentionally distributed outside that stte except for
   waste disposal.  This Includes all factories, storage
   places, and warehouses at the stte.  An example would
   be an intermediate' which is further reacted oivslts to
   produce a pesticide.

   Consumer • The new chemical substance or products
   contelninQ ttw imffnlnntHf will  be  used by privets
   individuate In or around  a residence, or during
   recreation, or for any other personal use or enjoyment
   e g., automotive polish, dyed  wearing apparel,
   household cleaners,  etc.  If a  consumer use Is
                                         ntinuation
   InformaHon to be provided on an attached
         A «4AtAllA«4 «4AA*M|M||MM «*f MhA IMA M0 MfeA M^M
         a ueiaiwa oescnuuufi or Die use or me new
   chemical substance expected hi consumer products
   and any reactions that occur causing the substance to
   tose its identity in the consumer product
             inO RvW CffMfRiCeU SUDStkVtOO OT pfOOUCS
  containing the substance will be used at the stte of
  other manufacturers or processors, e.g., textile dyeing.
  paint formulation, use of a curable resin to manufacture
Commercial • The
                                          or products
  containing the substance win be used by a commercial
  enterprise providing a consumer service. e.g.. use by
  coffunofcieU ofy ciOsViinQ (MttoutftfiMfitBt mo Dy
  painting contractors, or use by roofers In commercial
  building construction.

  Mark an boxes, as appropriate. For example, a
  surfactant hi an automobile wax may have a consumer
  use In liquid wax, • commercial use In auto washes.
  and an  industrial use by automobie manufacturers.
  Mark the binding optfon statement where applicable.
  Note! You rrwat fitsiDe separate confidentiality claims
  for the desorlpBOJi of tne category off use, ttw percent
  of production devoted, to each category, the percent in
  formulation, and category of use Information.

  The information In this section te used to evaluate
  potential exposure and release of the new substance. If
  you wish to provide any additional Information which
  would assist in this analysis, it may be submitted as
  optional information.
                                                            c.  Generic use description - For each category of use
                                                               description which is claimed as confidential, provide a
                                                               generic description of the category.  Identify the
                                                               category of use to which  the generic description
                                                               applies.  The generic use should reveal the intended
                                                               category of use of the maximum extent possible. For
                                                               example, the specific use of a new substance ss an
                                                               antioxldant In a lubricant could be described
                                                               genericaUy as a lubricant additive; a fiber-reactive dye
                                                               for nylon carpeting could be described generically as a
                                                               dye for fibers. If such a generic description does not
                                                               provide a sufficient Indication of potential exposure, the
                                                               description can eJao describe ihe degree of
                                                               containment of the new chemical substance, as shown
                                                               In ow list DwCw? ntMe*vwt n QaVMrto uSe) dsMoripoon
                                                                                              r containment such
(a) destructive use


(b) contained use
      (e.g., fuels, fuel additives
      chemical Intermediates)

      (e.g., catalysts used In
      cloned processes, certain
      photographic chemicals*
      capacitor fluids)
                                                               (c) open, non-dispersive   {e.g., printing inks, textiles,
                                                                 use                   dyes, piasticbers, adheslves,
                                                                                       liquid paints, resins)
                                                                 W
      (e.g.. cutting fluids, fabric
      softMWfftt ttitofnobtte tlra
      rubber)
                                                               (e) highly dispersive use   (e.g.. pesticides, fertilizers,
                                                                                       •AM 4bM «iA_b^MM fi nljit
                                                                                       San rar oeHCuig. pami
                                                                                              , spray paints)
                                                               (T) other
      (describe)

• Indudo in tfw notion ft copy oc
 off ftny huMd wevnlny
                                                              label, material safety date, sheet (MSDS). or other
                                                              information which wOT b* provided to any person
                                                              regsrdinQ pioteBove equipment. engineering controls,
                                                              or practices for the safe transport, use, or disposal of
                                                              the new chemical substance. V hazard warning
                                                              Information Is not yet prepared, describe the statement
                                                              you Intend to provide. M any. You are not required to
                                                              develop hazard warning statements for this notice if
                                                              you do not otherwise intend to do so. Identify copies
                                                              of hazard warning statements or other hazard
                                                              Information that you  attach In Part in. List of
Page 9
-------
 PMI-  HUMAN
                            AND BAflROMUBtTAl.
                          8-10)
 In sections A end & you must provide Information on
 manufacturing, processing, and UM operations Involving
 the now chemical substance or products containing the
 nsw substance.  Preparing a ohsniioal lor an and uss
 application typically involves several production steps, or
 operations, whore potential human exposure and
 envlronmontaf nlisii could occur.  Use section A to
 provide Irrtormaflon on operations that occur at Industrial
 sites you control. Typically, this wB Involve manufacturing
 and processing operations.  Use section B to describe
 operations that occur at industrial sites conoci'ed by
 atrtsrs. Typlcs9y. tills will Involve processlr^ ».-.d end use
 application*, e.g., dyeing of nylon carpeting, paint
 spraying of automobiles*

 For example, for a solvent used In automotive paint for
 automobile' manufacture, there are solvent manufacture,
 paint manufacture, and Industrial paint spraying
                substantially among the different sites, you must provide a
                separate section A tor each different type of "{mitten

                1.    Operation Qescriptton

                  •> kjsndty • usnttfy the sits which the section
                     describes. V this section describes more than one
                     arts, provide additional site Identities on a
                     continuation sheet  Indicate the total number of
                     sMss at wMeh the operation this section describee
                     win occur. H you mark (X) ttw confidential box next
                     to this Mam, all information In tt will be treated as
                                                                ix  TVpe - MM. ,X) the app. .pitate box.
                                                                   Amount and duntton • Eattmafta ttw nuudmiifn
                                                                   amount of ttM now aubatanoo fnanufactuvodi
                                                                   pfOOOaaadi Of UOad efl thO OpOtfBtlQn aftd tllO
                                                                   duration of the operation.  Provide Information per
                                                                   batcfi for batcfi Qpafottona and paf day for
           Paint manufacture may occur at a sMe you
control or at a sits you do not control.  • paint
manufacture oocura at a alto you coirliul, describe that
operation hi section A.  B paint manufacture occurs at a
sita )^u do not oontfoi* daacribo that opofaflon in aacoon
B. If processing or end use operations occur at Industrial
                         BtiOf
                                                                            tho RianuteduflnQ, prooasdnQ, or uao
                                                                            Involving ttw new chemical substance.
slfiaa you oontralv ttMy aliould bo
                                       In aoctfon
to most cases, you wiO have more specMe Information on
sites you control than sites you do not control. B you do
not have specrAo Information on sites controlled by others.
describe a typical <
                     ition involving ttie particular
                     (•|. Uanflly ttw nuiyOf unit opanoon atapa and
                     chemical conversions.  "Unit operation* means a
                     functional step In a manufacturing, processing, or
                     use operation where substances undergo chemical
                     changes and/or changes In location, temperature,
                     pressure, physical state, or sfanOar characteristics.
processing or end use eppUcatton baaed on IANUI
available to you and on your experience wHh siml
           Provide an Information requested to ttw extant
to which It Is known to or reasonably ascertalnaple by
you. Where EPA has available only Hmrted Mormation on
worker exposure and  envfaonmentaJ release,  Ms evaluation
witt be based on rcosanaMs worst case aiiumptioni.

Note tftat M you are an importer. aflHough you do not
two to oofflplolo aoctton A of B fcf opocanona ouMda tna
United SMee. you may sol have to report Information m
               • viavo aio mrtnar indi*eieVuJ  pfoooawiQ or
              aftr Import off tho aubaianoo. you muat
              opaRBaHno bi aacoon A or B oa appcopfiata.
                                                                              i in wtHcn vio naw aubatanoa la
                                                                   fonnualBd Inlo Qaia^ fnoduvaav auaponaionai
                                                                   aohmona. ote.

                                                                   (2) Intfcala In your diagram tho antfy point ot afi

                                                                   1^ ABk^ ^^^^^1^^^^^^  l^a»^^aeVfl ^k^t^^ e
                                                                   n vi«i opacvDOfL  nanmy •BUI I
                                                                                          kQ/bolcn fw baton
                                                                                           oonlalninQ ttta now
Coirtptota o aaponia aocdon A fof <
nunufactufinQ, pfOooialnQ, of uao (
                                   > type of
                                   atfonbM
                                                                              Mark ttw box H you wish to bidtoxto
                                                                   your wOkigness to have your |
ngthe
operation ia performed
                     e at sites you control.  Bthosame
                     at more than one site, you are not
reQulrod to complete a separata section A for each
operation, but simply dascrfbe the typical operation
common to these sites.  However, if operations vary
Page 10
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   For exampjai -


           SAMPLE MANUFACTURING OPERATION
Stannic
Chloride
BOO kg/batch
           IT
                       Mix Tank
                           T
                                              1
 200 kg/batch

-TElttutyl
 aluminum
 900 kg/batch
chkinoe —_
300 kg/batch

To Recycle
                      Mix
                      Tank
                   I   Centrifuge
                       Distillation
                       Column
                      NewChemicei
                      Substance .
                      Drumming   ..
            SAMPLE PROCESSING OPERATION
    New Sub
                 (500 kg/fey)
   (ISOkfday)
   (250 kg/day)
   (Earth (100 kg/day)
                            Banbury Muter

                            Dramming or
                                T
                                  3
  2. Occupational
    Column (1) - Ossorioe each specific activity In the
    operation during which workers may be exposed to the
    new chemical substance. Such activities may Include
    charging reactor vessels, sampling tor Quality control,
    transferring materials from one work area to another,
    drumming, bulk loading, changing filters, and cleaning
    AJB. (IfhMkAM* AIM   A^^kflM^^ *•••••• ftkA «4M^MMlkA«A ^B^MMft U
    equipment, etc..  /muviues mus* DO oesonDeo even IT
    workers wear protective equipment  (Material Safety
 Data Sheets indicating recommended protective
 equipment should be submitted as part of Hazard
 Information in part I, section C. subsection 3 of the
 notice form)

 Column (2) • CBI claim for worker activity.

 Column (3) - Provide information on the specific types
 of protective equipment and engineering controls that
 will be employed to  protect the worker from potential
 exposure to the new chemical substance. I.e.. gloves.
 goggles, 21c respirator, I9c respirator, closed
 containment system, nitrogen blanket etc..

 Column H) - Binding option for protective equipment
 and ongineonng controls.

 Column (5) - Indicate the physical form of me new
 suomanco at the time of exposure, e.g., solid  (crystals,
 granules, powder, dust), liquid (solution, paste, slurry.
 emulsion, mist, spray), gas (vapor, fume), wet press
 cake, even H workers wear protective equipment

 Column (8} - Binding option for physical forms.

 Column (7) - OBI claim for physical form.

 Column (B) - Estimate the maximum number of
 workers Involved In each specific activity, based on the'
 estimated maximum I2^nonth production volume.

 Column (•} - CBI claim.

 Column (10) - Enter the maximum duration that any'
one worker wffl engage-In  the activity In hours/day,
e.g.. 8 hours/day.

 Column (11) - Enter the maximum duration that any
one worker wM engage In  the activity in days/year,
e.g.. 200 days/year, based on the estimated maximum
 production volume.

 Column (12) • CBI claim.

 Note that you must make separate conftdentiaNty
claims tor tfw description of worker activity, physical
form of the new substance, number of workers
 ixposad. and duration  of exposure.  (See 2. 7. 9. 12).
                                                                 Column (1) - For each release point Indicated In the
                                                                 process description (Part II. Section A, subsection id(3)
                                                                 of the notice form, enter the corresponding number.
                                                                 Column (2) - Estimate the amount of new chemical (In
                                                                 kg/day for continuous operations or kg/batch tor batch
                                                                 operations) that will be released from the release point
                                                                 directly into either (a) the environment or (b) into
                                                                 control technology (In kg/day or kg/batch).  Base your
                                                                 estimate on the expected maximum twelve month
                                                                 production volume.
  Page 11
-------
   Column (3) .JJBixlaim.

   Column (4) - Enter the madia (air, land.
   which the release stream dischargee
   control technology to ueed).
 into
or not
Column (5) (a) For retoases to the air and water,
describe the type of tschnology used to control the
release of the new chemical and the efficiency of the
control technique.  Examples of control teohnotogtos
Include carbon filter, scrubber and biological treatment
(primary, secondary, etc.).  Use the optional binding
box to indicate your willingness to be bound to control
technology described, (b)  Enter the estimated amount
released to the environment after control tschnology On
kg/day). Enter 'none' H no control technology to used
and tho substance is released directly into the
environment

For disposal on land, describe the landfill site
construction (including liners) and handling procedures.
Describe landfill containers.

Column (B) - CBI daim.

Column (7) • Mark  (X) the appropriata box and/or
specify other destinations of water retoases.  (i.e.,
POTW (Publicly Owned Treatment Works), navigable
wstofwsy or spocHy otnor). ProvUo tho  nomo of tho
POTW receiving water retoaaes and the NPOES
(National Pollutant Discharge Elimination System)
number for the POTW, navigable walaiway or other
direct discharger.  This g-dlgtt number to assigned by
EPA or the State under the authority of the Ctoan Water
ACL  When appropriate, contact your POTW to  obtain
their NPDES number.

Note that you must make separata confidentiality
claims for the release number, amount of new chemical
substance released, control technology disposal
information, and the- destination of tfia ratoasas to
water.
Complete a separata Section B for each type of

of use specified in Part 1, Section C. subsection 2a at
industrial sites you do not control.  If the same operation
is performed at moretfian one site, then describe the
typical operation and ontar ttia number of sties in Ins
space provided.
1.
diagram above and complete columns 2-8 for each
worker activity associated with the totter.

Column (2) • Estimate the maximum number of
workers exposed to the new substance during the
                                                                Column (3) • CBI daim.

                                                                Column f4) - Estimate the duration of exposure of the
                                                                new chemical substance per worker in (a) hours per
                                                                day and (b) days par year.

                                                                Column ft • CBI claim.

                                                                Column |B) - Provide Information on the protective
                                                                equipment and engineering controls employed to
                                                                safeguard the worker from pctanflaJ exposure
                                                                associated vaffi, ftc ne*- ctasrAul SubsUnca,..«..
                                                                Column (7) - Estimate the percent formulation of the
                                                                new chemical substance in the product to which the
                                                                worker to potentially exposed during the activity.

                                                                Column (B) • CBI daim.
                                                                            Enter ino ftuFttott of rotoftso points In
                                                                roforonoo to tho prooon dteQntfn ibovo wid oontptoto
                                                                9-13 for each release point tdentfftod.

                                                                Column (10} - Provide an estimate tor the maximum
                                                                amount of new chemical substance In kg par year that
                                                                may be released to the workplace, air, water, or land
                                                                under typical operating conditions.  Provide this
                                                                information tor retoases (a) directly to the environment
                                                                or (b) Into control tschnology to the environment in kg
                                                                par day or kg per baton.
                                                                Column (11) - CBI daim.
                                                                       (12) - Descrlb
                       ntrol tech
                                                    ology which to
                                                             to tno
used to Omit the release of the new i
environment to the extant that the Information to known
to you.

Column (13) - CBI daim.

Column (14) - Identify all byproducts resulting from the
reaction to the extant that the Information to available
to you.
                   Note that you must make separate confidentiality
                   claims for the numbers of workers exposed, the
                   duration of exposure, the percentage of the product In
                   formulation, tfia amount of new substance released,
                   and the control tschnology.
2. Worker
  Column (1) - Provide the totter for'i
      12
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(OPTIONAL) POLLUTION PREVENTION .AND RECYCLING
INFORMATION page 11)

This page requests optional information that will to used
in tn« •valuation of ttw new chemical substance and a
compariaon of ttw relative risk* and benefits of ttw
substance aa a subaMuto for subatanoaa currently on ttw
market  PMN submMsrs ara anoouragad to report any
and all relevant Information not reported elsewhere which
la believed to to Important to a thorough regulatory
Part •-LIST OF ATTACHMENTS  (Page 12)

Attach any continuation sheets for ssctfone of ttw form.
test data and other data (Including structure-activity
information), and optional Information after ttw last page
of the toon. Oeariy Identify ttw attachment and ttw
section to wMch K relates. H appropriate. Number
consecutively the pages ot ttw attachments. Enter ttw
Inclusive page numbers of each attachment Enter the
total number of pages In the notice on page 1 of ttw
form*

Mark (X) ttw •Confidential' box  next to any attachment
rwma you dalm as confidential. Read part L section Cl
on page 2 of this manual for guidance on how to dalm
any Information m an attachment as confidential. You
must Include with ttw sanitized copy  of ttw notice a
sanitized version of any attachment In which you cialm
Information as confidential.
                       EPA1 review of ttw
physical/chemical property Information you submit is
provided on ttw last page of ttw form.  Providing
physical/chemical property Information In fMa format la
optional. However, physical/chemical properties data In
your possession or control must to submitted with your
notice. V you submit this worksheet Identify K on ttw List
of/
      13
-------
                                    II.  SUPPLEMENTARY INFORMATION
 A. Who Mutt SubmB A Prarnanutatura
 If you intend to manufacture or Import a new chemical
 substance tor a oommerdal purpoaa. you must submit a
 premanufactura node* to EPA. You must submit a notice
 if you intend to Import a new substance In bulk form or as
 part of a mixture, but not H you Intend to Import the
 substanoB only as part of an article.

 Premanufactura notices  for Imported new chemical
 substances should be submitted by the principal Importer.
 •Principal Importer* la defined In §72O3(r) of the
 Premanufactura Notification Rule.
 Generally, when you i
 manufacture a new d
             rrtract wfth another person to
                          s, that person must
 suomn the notice However, If you request another
 person to manufacture a new chemical a
 useful to the Agency's review of  the new chemlesl.
 Therefore, EPA strongly encourages Joint submission In
 these situations (see section E£ below).
 This manual does not discuss biotechnology submission
 information requirements for uses of microorganisms
 subject to the Toxic Substances Control Act (TSCA).  For
 specific Information on submitting notices for
 biotechnology products please contact the Program
 Development Branch (TS-794) (Biotechnology Program) of
 the Office of Toxic Substances.
 For additional in
          bttion on who must submit a notice.
 see §720.22 of the Rule or consult the Prenotice
 Coordinator.
              Which m
  1.
        • You are rssponsiole for determining
whether • substance you Intend to manufacture
or import to • •new* chemical substance aa
defined by fho Act and § 72O3 of the Rule.
You must submit a premanufactura notfos for
any new chemical substance which Is not on the
TSCA Inventory or otherwise excluded from
notification, i
                         (for a TSCA
         The specific identities of some chemlesl
         substances on the Inventory era confidential and
         therefore do not appear on the Inventory
         available to the public.  Such substances
         are described by generic names in the Appendix
to the Inventory. ,V a substance you Intend to
manufacture or import la not on the published
Inventory but falls within one of the generic
categories in the Appendix, you may request
that EPA search the Inventory's confidential file.
EPA will search the confidential file only H you
can demonstrate a bona fids Intent to
manufacture or Import the substance. Section
7202*kof the Rule describes the procedure for
demonstratlnQ such a bona fide intents

After conducting Ks search. EPA will tell you H
ths substance Is Included on the kivsr.to.-y and
therefore not subject to p.-«nunuiaciure
nouncaUuii or if you must submit a
premanufactura notice.
                                                     1.     General • Section 72O30 of the Rule excludes
                                                            certain substances from premanufactura
                                                            notification.  These Include mixtures) substances
                                                            manufactured solely for use as pesticides, food, -t
                                                            food addMves. dnigs." or cosmetics; tobacco and-

                                                            firearms and ammunition; impurities; byproducts
                                                            which have no commercial use; non-Isolated

                                                            manufactured solely for export; and substances
                                                                       I In § 7203001)0.7).
        i and development (RftD) exemption -
R&O Includes synthesis of new chemical
substance* or analysis, experimentation, or
research on new or existing chemicsl
substances, including product development
activities. R&D may include tests of the
physical, chemical, production, and performance


You do not have to submit a notice for a new
substance manufactured or Imported fn small
QuarrtHtee aDioJy for research and development
as specified in § 720.36 of the Rule. -Small
quantities* are those not greater than reasonably
necessary for research and development
purposes. The quantity which Is reasonable
may vary depending on the segments of the
industry or the nature of the research and
development activities. R Is your responsibility
to determine what is reasonable in your
situation. You do  not have to apply for this
exemption. However, you must submit a
premanufacturo notice 90 days before you
Intend to manufacture the substance for s
purpose other than research and development.

To qualify for the exemption, your research and
      14
-------
development activities must be conducted under
^supervision of a technically qualified
individual.  Persons who engage in R&O for. or
obtain an R&D chemical from, a manufacturer
must be notified of any risk to health which may
be •••pruned with the chemical. However. R&D
conducted entirely in laboratories under prudent
laboratory practices era exempted from the
requirement for risk evaluation.

In accordance with 40 CFR 720.78, the following
R&O records must be retained: Information
reviewed and evaluated to detennine the need
to make any notification of risk, documentation
of the nature and method of risk notification.
documentation of  pcudont lab practices used
Instead of risk notification and evaluation and. If
an R&D substance la manufactured at greater
than IX kgs/yr, records regarding the chemical
Identity of the substance to the extent known.
the production volume, and the disposition of
the R&D chemical substance must also be
retained.

Manufacturers and importers who distribute an
R&D substance to other persona must provide
those persons with written notification of known
hazards arid of the requirement that the
substance be used solely for R&D.  For
m jlgMltim e>l le«oVfc«we»a4t«Mt «•*• fH f\ *MM« •l*M«eMAMA*B ^^^e>
aoononai HiiuiiiiaDon on HAU requjiemsnis see
   Test Marketing available from the Environmental
   Assistance Division (see Section H, Part O of this
   manual for addresses and tslsphono numbofs).

   • osHnartBBOng SBeMnpelona IIHBS^ • You may
   apply for an exemption from premanufacture
   notification If you plan to manufacture or Import
   a new chemical substance for tost^iiancettng.
   Test-marketing Involves the distribution of a
   predetermined HmMed  amount of • chemical
   substance, or of a mixture or article containing
   the chemical substance, to apecMed number of
   customers to eMptoro morkot eoce^teoaHy before
                                                                Officer (TS-790). You are not required but are
                                                                encouraged to UM the PMN form for« TME
                                                                application.
   To
   application, HeO AQSncy fflUSt mSNO an
                   i MIMA aw*A  ^^—^4 ^^_^_i^^i
                    um mw iivw cnwnmi
                not present en unreasonable risk
   to hMlffc or tho en^renment during the test-
   meiffcoflnQ OGeMlieSi Section /ftft 39 of tho Pule
   Identifies the typo of Information you should
   submit with a tsst^nsnioting exemption
   application.  EPA must sppnwo or deny tho
   application within 45 days.  .H you do not
   provide sufficient fnfofmation foe EPA to make
   Ha determination within 45 days, the Agency will
   dony tho^ request.

   You should send applications for test-marketing
   exemptions to the OTS Document Control
                                                                      1590(4) •usmpicna - Under section
                                                                5(h)(4) of the Act you may apply to EPA tar an
                                                                exemption from some or an premanufacture
                                                                notification requirements. EPA may grant an
                                                                exemption if K makes an affirmative finding that
                                                                the manufacture, processing, distribution In
                                                                commerce, use. or disposal of the new
                                                                substance wffl not present an unreasonable risk
                                                                to health or the environment Unlike other
                                                                exemptlonS( sucn as tsst mafkoting, EPA may
                                                                only grant a section 5(h)(4) exemption by rule.
                                                                b« M^A M I^MMM^IMM MMMMhAAddl^^ UkA	«.	.
                                                                n me nuemamng prooseomg, we applicant
                                                                atmj Ar\ M«vte^4^ kkfck«*H»^41«^M	«^—*	f. ^_ —a. nl,,
                                                                •nouia fNuviue vnormaDon IUIIK.MMI n snow
                                                                that the chemical substance win not present an
                                                                unreasonable risk to health or the environment
                                                                You ahould •end applications for section 5(h)(4)
                                                                exemptions to the OTS Document Control
                                                                Officer (TS-790). The following 5(h)(4)
                                                                exemptions have been promulgated:
                                                                a.  tow Volume Dcempdon (LVE) - Requlremerna
                                                                for a LVE application are found at 40 CFR
                                                                72&90. This exemption Is available for
                                                                •utMtsVioos nuuiutecliifod In quttntMos of 1*000
                                                                kg or lost por yoar. Only ono •xomptton Is
                                                                •vailabto por tub«l»noo regardta
                                                                           Low volunio substanoM wo not
                                                            •.ddod to tho TSCA Inytntory; howovor. a
                                                            Mpontto Invontofy of LVEs gnntod Is
                                                            nuintolnod*  Ttw fiunuffftctufor must submit s
                                                            •our volumo oxomptton (LVE) nottoo to EPA st
                                                                121 dsyo prior to nrunuracturing tho
                                                                       Tho nottoo must Indudo tho arts of
                                                            monufsotura and proposod usoof tho now
                                                            ehsmtesl subotsnoo which aro logaHy binding
                                                            upon tho oompsny.  Tho mtvuifsctufof may slso
                                                                   infofvnaMon on oxposurs controls.  •
                                                            •^l^^el^e^ak af^^Aaa^^k^u A ae^^ ^k^MBW^ ^^ aeV^ »m^**m**^t**^
                                                            Ueietaie|p Qiuu^ioui wio psnoo OT mo sxvn»piion«
                                                            EM wfl grant the LVE If R detsrmines that the
                                                                      wfcH not present an unreasonable rtsfc
                                                            Oompaniea must submtt a new exemption
                                                            nodea before they change the site of
                                                            manufacture or application.  Manufacturers
                                                            (Importers) must notify processors and industrial
                                                            users that the substance can be used only for
                                                            the uses apecMed in the exemption notice.
                                                            Manufacturers must also notify processors snd
                                                            users of any exposure controls.

                                                            Under this exemption, submitters must maintain
                                                            records for five yearn concerning the annual
                                                            production volumo of the new substance.
                                                                   mtation of Information provided in the
                                                            exemption notice, and compliance with the
                                                            terms of this section. See Section II (I).
IS
-------
         b. Pojymer Deernpuon - Requirements tar a
         Polymer Exemption can be found at 40 CFR
         723.250.  This exemption is available tor certain
         dassM of polymers which are not ehemleally
         active or btoavaUable.  The manufacturer must
         submit a polymer exemption notice to EPA tar a
         21-day review.  EPA will grant the exemption if it
         determine* that the substance will not present
         an unreasonable  risk of injury. Unlike the other
         exemptions, substances subject to Polymer
         Exemptions are added to the Inventory and a
         Notice of Commencement must be submitted
         when commercial production commences.

         Manufacturers must specify residual amounts of
         monomers In a polymer and are bound to those
         quantities. If the residual levels exceed the
         specified limits, a manufacturer must either
         submit another exemption or a PMK. Tha
         simultaneous submission of a polymer
         exemption and a PMN Is acceptable. However,
         separate notices and user fees must be
         submitted for each type of notice*
The poly
                               also retains a five year
                     ixempi
         recordkeeping requirement.  See section II (I).

a When to Submtt* Note

You must submit a premanufacture notice at toast 90 days
before you begin to manufacture or unpoit a new
chemical substance tarja pommerdal purpose..
If you are manufacturing two or mom structurally similar
new substances, you may contact the pranotts*
coordinatof (seC'Scction G.1.b. below) to obtain approval
to submit a single consolidated notice. A consolidated
notice is suitable for chemical substance* of sMhv
structure with the same or similar uses and which share
similar test data and other information.
notice must Identify each new substance Individually; you
may not submit a consolidated notice for an open-ended
category.  A separate chemical identity page must be
provided for each substance.  A distinct Agency TON*
number is assigned to each'chemical. You may not
submit a consolidated notice for a series of Intermediates
and a final product frtttmr they do not share common
uses, test data, and other Information. EPA encourages
you to submit consolidated notices when appropriate.
However, you may not submit a consolidated notice
unless you have received prior approval from the
prenotice coordinator. Remember to enter your prenodce
communications number In Part I. Section A (3) (page 3)
of the form.

F. Submission off Information by OOMn

  1.      Submission by an agent • You may designate
         an agent to submit a premanufacture notice for
         you. Both you and the agent must sign the
         certification on the term. You are responsible
                                                      1.
tor ensuring that all Information known or
reasonably ascertalnaMe by you and all test
data in your possession or control are submitted
to EPA. For information en submissions by
agents, eee § 720.40(e) of the Rule.

Joint subrnMona - You may also prepare and
•; :Dmit a premanufaeture notice with mother
  iraon. A Joint submission may be ueful where
different persons have Information required in
the notice. For example, you may have
Information on the Identity and the physical and
chemical properties of the new substance and
another person may know Ha manufacturing
process and its intended use. A Joint
submission may also be useful when another
person has information fundamental to the
notice, but wishes to keep tt confidential.

Each Join*   —nltter must use a notice form and
sign the       4tfon on ine form.  Each person
must ate.     .1 all confidentiality claims as
described   , 720M of the Rule and Part I of
this manual.  However, you are not relieved of
statutory  notice requirements by arranging  a
Joint submission. You are required to complete
aH mandatory ssctions of the form to the extent
that you know or can reasonably ascertain  the
information, even M another person also submit*
information for a certain section.  H you submit
a Joint notice, the review period wHI not begin
until EPA has received all required parts of the
notice." You should Identify the Joint submitter In
your notice and identify the ssction(s) which the
person Is submitting.  See § 720.40(e) tor
additional Information on Joint submissions.
                                                                   wtti ERA GDnoameiO; flic Ptarnanufactuni
                                                                                General Inquiries
                                                                   ilng the premanufacture notification
                                                             program which are not related to a specific
                                                             ,^ , ^Ta •! ^m M4MIIAA ~*	'-* t»A ^le^j&mft 4M 4hA
                                                             cnemicsi or nouce snoun DO airecno TO me
                                                             Environmental Assistance Division. Copies of
                                                             the Rule. Instructions Manual, notice form, and
                                                             other materials relating to the Rule are available
                                                             from this office. (These materials are also
                                                             available at EPA regional offices.) Persons may
                                                             contact this office In Washington at 202-554-
                                                             1404.  Written inquiries may be sent to:

                                                             Director. Environmental Assistance Division
                                                             Office of Toxic Substances, TS-799
                                                             U.S. E.PA
                                                             401 M Street. S.W.
                                                             Washington, O.C.  20480

                                                             L  AMAA^BK ^B^M^flAA  1*."l m nmn IjxJ^ulrfa•
                                                             D.  speono MQjuaieB - 'jpecirw inqumoa
                                                             concerning the Rule, confidentiality, Joint
                                                             submissions, oonsoUdated notices, etc., should
Pag* 16
-------
H.
         be directed to trie Prenotlee Coordinator.
         Peraonr may contact the Prenottoo Coordinator
         by telephone (202) 382-3745.  Written inquiries
         may be ssnt to:
         Pronotioo Coordinator
         Chemical Control OMskm
         Office of Toxic Substances, TS-794
         U.S. EPA
         401 M Street, S.W.
         Washington. D.C. 20460
         During notice
• The notice review period
 begins upon receipt of ttw notice by ttw OTS
 Document Control Officer M your notice Is
 determined to be "completo". However, you will
 receive written notification « your notice la
 declared Incomplete1 as described at 40 CFR
 720.66.  « your notice Is complete, you win
 receive an acknowledgement totter tatting you
 your notice number and the date of expiration of
 ttw review period. The Inventory la searched to
 ensure that ttw substance for which the notice is
 submitted Is not already included on the TSCA
 Chemical Substance Inventory.  If your chemical
 substance Is on ttw Inventory, you wU be
 notified that your substance Is not subject to
 premanufacture notification, and therefore you
 are free to begin manufacture Immediately. V
 tno suDsunoo it not on tno ffivonvofyi o PiOQfeWi
 Manager la assigned to coordinate the review of
 the notice and to be your official contact with
 ttw Agency throughout ttw review period.
 During ttw review period, ttw Program Manager
 may contact you for clarification of Information
 you have provided In ttw notice or M the Agency
 identifies Issues of oonosm.  If you are not
 contacted prior to ttw expiration of ttw review
 period, you are free to commence manufacture
 of the substance Identified hi your notice after
 the review period has expired.

 The Program Manager wU aleo notify you before
the review period expires If he/she wM extend
the review period under TSCA section S(c) or If

substance under TSCA section Sto) or Sfj).  S(e)
Consent Orders are typtoaBy Issued wtth a
follow up SjNUR-aubooQuontfy piomulgated.  in
addition. • Program Manager wffl contact you If
the Agency plans to develop • non-8(s) SNUR
 (a case hi which a 5(s) Consent Order does not
precede the development of a SNUR) on ttw
chemical  substance Identified to your notice.
         Notice of i
                    (or Import)
    : (HOC) of
If EPA has not taken any action to regulate the new
chemical substance during the review period, you may
begin manufacturing the new chemical substance upon
                                 expiration of the review period.  EPA requires that you
                                 notify the Agency by letter no later than 30 calendar days.
                                 after the first day of such manufacture or Import

                                 Your notice of commencement of manufacture should be
                                 sent to the OTS Document Control Officer (TS-730).  hi
                                 your letter, you must provide'the specffio chemical Identity
                                 of the substance. Its prsmanufaeture notice number, and
                                 the date when manufacture or Import began. You must
                                 also substantiate a confidentiality daim tar chemical
                                 identity In your totter N-you want EPA to maintain the
                                 dalm after you begin manufacture or Import. See40CFR
                                 720.8S(b) for further Information on substantiating
                                                                               a NOC and you wish to be
                                • you
                                of the TSCA Ch
                                                                              MfttNOCandtwOhsmlcal
                                                                              Sp nuRBor 0Qff iMffr^onnitantffll
                                                                          4 IB/ Aeeeeetan number (a 5 dkjtt
                                                                                                      > tor ttw
                                                            Document Contort OHeer (18-790);
                                                                         to ttw OTS
                                                                        ChamtaeJ
                                Section 720.78 of ttw Premamifeeture Notification Rule
                                requires that you retain doounwnlallon of Information Ire
                                ttw promanufecturo notice for five years from ttw date of ~
                                commencement of manufacture.  The records you must
                                retain Include (1) Information supporting the Information
                                supplied on the notice form, (2) other data, as defined In
                                § 72O50 (b) of the Rule, In your poissislon or control. (3)
                                production volume tor the first three years of production
                                or Import, and documentation of production volume, and
                                (4) date of commencement of manufacture, and
                                documentation of this date.  For example. If you
                                performed a market analysis to estimate maximum
                                production volume aa reported on ttw notice form, you
                                would retain ttris analysis, even though production volume
                                and market share may change, * you have performed a
                                chemical analysis te.delermlne what byproducts may
                                result from operations at sMes you control, you would
                                fOtMfl wMt ttfUeflyieoV YOU WO Mt IVt^UsVOQ tO QOVOiOp

                                           ation you have obtained or developed In the
                                                            etain Info
                                                                  of completing your submission.
                                                            V you manufacture a i
                                                                        tundortho
                                                                                            irod Mtoiy for
reesarch and development* you must retain
documentation of oornpUanoo with the exemption for five
years from ttw •net date of manufacture or Import under
the exemption. If you manufacture under a test-marketing
exemption under TSCA, you must retain documentation of
Information In the application and documentation of your
compliance wNh any restrictions imposed by EPA when K
granted ttw application. You must retain this Information
for five years from ttw final dale of manufacture or import
under ttw exemption.
     17
-------
A manufactuhV of • polymer under ttw turn of ttw
polymer exemption at 40 CFR 723JSO must maintain'
records for fivo yean from ttw date of oonuiwneament of
manufacture ton ttw production volume for the first three
yeara of manufacture, the date of oommenoement of
manufacturOt docufflantnon of ttw Infomudfon provided
     i docuinanttfJon of any other I
in the notice such aa, bikNiiiattoii that domoratratea that
the new polymer la not apaefflealy excluded from the
exemption and ttw polymer meets ttw exemption criteria.

Eaohmanulaelurarofanawautaalafwareportadundarttw
farm of • low volume exempdon at 40 CFR 72180 mutt
maintain reoorda of 1) the annual production volume of
                        under the axemptton. and 2)
Pag* 18
-------
                                             EXAMPLES OF TEST DATA


 Following to • IM of «M types of tast data which you must attach to the notice form If H to In your possession or control. This Itet
 to Hluslrallvs, not exhaustive.
 Chromatograma                             Mutagenldty                                 Mterobial bioassay
 Spectra (ultraviolet.                           Cardnogenlctty                              Algal bioassay
    visible. Infrared)                          Teratogenldty                                Aquatic macrophyta
 Denoty/relailve                              Neurotoxldty/                                   bioacsay
    density                                     behavioral effects                         Seed germination and
 SolubHIty In water                            Pharmaoologlcai                                root elongation
 Matting temperature                             effects                                   Seedling growth
                                            Olstributlofi
Softening point                              Meteboltom and                              Acute toxWty to
      pfMfluw                                 •xnvtfofi                                    inwtaAfilM
               stant                         Cumulative, additive                          Ufe cyde test on
       ml^mm.                                    rna
       wZV                                    W
    distribution                                  •ftocfe                                   Acuts toxldty to
                                            Aouto( subduonlo                               flsn
                                               flnd chrenlo •frectB                        EaUiy uta itBQO
Henn/a law constant                         Structure/activity                                (Bah)
Volatilization from                               relationships                             Avian dietary/
    water                                    Epidemiology                                  - reproduction
Volatilization from                            Reproductive effects                          Boacoumulation/
    sou                                     Cnueal studtaan>                                btoconcentration
pH                                         DsNnattudcNy                                Model ecpsystem
Flammabiltty                                PnototoxioHy                                    studies.
ExptodabiUty                                Irritation                                     Physical environment
Adsorptfon/desorptfon                        SensMzaBon                                    Impairment effects
    characteristics                            Allergy                                      Resh staining of
Photochemical                               Skin staining                                    aquae/organisms
Viscosity
Odor
Hydrorysto
Chomteal anatyvte
CnofluCfli oxidarfoii
    Of tOXlC pfOQUOtB
     19
-------
                                                                      Form Approved. O.Nta No. 2D7D-OOU. Approvil Expires 1-31-94.
              U. SfENVIRONMENTAL PROTECTION AGENCY

                       PREMANUFACTURE
                             NOTICE

                  FOR NEW CHEMICAL SUBSTANCES
                       DOCUMENT CONTROL OFFICER
                       OFFICE OF TOXIC SUBSTANCES, TS-790
                       US.EJ-.A.
                       401M STREET, SW
                       WASHINGTON. D.C 20460	
 Enter the total number of pages
 in the Piemanuf actore Notice
                                                                                 AGENCY USE ONLY
                                                                D«te of receipt
                                                                DoCUBMBt OODtVOl nUflRMF
                                      GENERAL INSTRUCTIONS

      	r	^eated mthte tern to me extent that it tefaMwa to or rcamiablyaaeectaia^
      Make reaaooable eadmatea if yoo do not ha*e actual data.
      - -  -         .....        	—  .      .	...— -vafM^fayftn^UntlflraHffn*fli"*'wltimtMirntl).
  •Yon mo*t provide all info
     •If a user fee hae"been remitted for mil notice (40 CFI TOMS), indicate in me TS been above the TS-Bier fee identification
      number yon have generated. Remember, your ater fee ID number maetalao appear oa year ceneepondmg fee remittance.
   Part I - GENERAL INFORMATION

   Yoa part provide Ike ckcaUcat ideattty o* Ike aew<
   fabrtaaca, tnm U fom cbte Ik* IdealBjr a§ amBdntULYoa mff
   aalknii* aMlkcr penoa to nb«il Ike IdcaUr/ fat voa. bet jam*
   nbaMoa wtt aot be oMplele aad irrttw wUI aet beclm aanl
                                                       TEST DATA AND OTHER DATA

                                                                        ialtaatdataiavoaxi
   pan iktnld nfemot yo«r TS «HT • liel pip nf Ifcli fnm for n •|rlr« nf
   wttktht
---- ._, -- „ --      .
uqr tot data or otter due od my opUnul
                                                                              D
                                                                                     Y.
                                                                                               N.
   OPTIONAL INFORMATION

   Yo« «ujr tadwU ta IM MUat «qr
                                         ikM yo« teehda
                                         EPA to
                                                                       a-    D
                                                                              n •
                              D  *
                              D  *
                              n  •*
   CMKlWtt pOUVUOM ptWCttlMtt flM
                              tktf fM «9 WM! EPA to
                          MI MM pewlded te TM to
                          dfcu IUMUHM yo« M? MM
                                                                   n Y*  n *
   Biadiag OptfcM» Ia<
   opUoaCj EPAauftfiiaMe
   entaia aUtearaits lavoari
   II yo« wtok to
   Mpectt Im tkto Mttoe d
   tohuMheaJUortki
   talk*
                          MlkpfHjr adtr *MU« Me) to mdo
                          M 10% pmdarttoi voluM^ pfotecttve
                          ItvOjr btedfau cad •uambl*
                             klMEPA,]
                                                            CONSOLIDATED PMN - * OF CHEMICALS
                            iadkat* jroai wttBagaeai to be I
                    byauridafOOIaiMboatipiDvlded. SkovUtk*
   CONFIDENTUUTY CLAIMS
   at dide
   or bracket UMLafonuttoarDadjOaacDafidcalUL Ujroadatai
   iafoauUea la Ik* aoUo* » eoafldMtfld, foa aiaat pnrrid* a HalUMd
                                   EPAwttbjromr
                     11 raqmind, tater fo«p«e*ll

[3 SNUN CSIcalBcBatNewUeeNollGa)

CD INTERMEDIATE PMN- AS DEFINED AT 40 CFR 700UJ

QTMEA (Teat MirHrlagF»aapH»a>



PI POLYMER EXEMPTION- L-JtO)  or LjeO)

PI OTHER EXEMPTION - SPECIFY V
   imbaiMioa. ForaddlUoajllaMnKBouoadMailas latawttoaai
   anfideatial re*d Ike batndtoas MaaaaL
EPA FORM 7710-25  (Rev. 1-91)
                                                                        Replace* preview edition of EPA Form 7710-25.
-------
Public reporting burden for this collection of information a estimated to avenge 110 hours per response, including time for reviewing instructions.
searching existing daS sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden,
to Chief, Information Policy Branch, PM-22> U.S. Environmental Protection Agency, 401 M. St.. S.W.,, Washington. D.C 20460; and to the Office
Management and Budget Paperwork Reduction Act (20700012). Washington. D.C 20603.
CERTIFICATION
I certify that to the best of my knowledge and belief:
1. The company named in Part I, section A, subsection la of this notice fc
commercial purpose, other than in small quantities solely for research
Part I, Sections.
2, All information provided in this notice is complete and truthful as oft
3. laift submitting with this notice all test data in my possession or contr
or reasonaoty aaceruunabfe by me as required by §720.50 of the Frana
Additional Certification Statements:
If you are submitting a PMN, (including a polymer exemption notice in ac
PMN, Consolidated PMN, or SNUN, check the following user fee certifies
l~l The Company named in Part I, Section A has remitted the fee specific
n The Company named in Part I, Section A is a small business concern \
a fee of Sionin accordance with 40 CFR 700.45 (b).
If you are submitting a polymer exemption notice in accordance with 40 C
CJ The new chemical substance meets the definition of polymer, is not sp
and meets the conditions of the exemption.
If you are submitting a low volume exemption application in accordance
certification statements:
Tne manufacturer suomitting tius notice intends to manufacture or in
commercial purposes, otlusr than in small quantities souay for NUATCI
of 40 CFR 72350.
Q] The manufacturer is familiar with the terms of this section and willcoi
1 1 The new chemical substance for which the notice is submitted meets a
The accuracy of the statements you mate in this notice shoiki reflect your best prediction o

inn intends to manufacture or import for a
and development, the substance identified in
he date of submission.
ol and a description of all other data known to
itufaduie Notification Rule.
cordance with 40 CFR 723.250), Intermediate
ition statement that applies:
din 40 CFR 700.45 (b), or
mder 40 CFR 700.43 and has remitted
TR 723.250, check the following:
edfically excluded from the exemption,
with 40 CFR 72350, check the following
iport the new chemical substance for_.
i and development, under the terms
tnply with those terms; and
11 applicable exemption conditions.
f me anticipated fads regarding the chemical
subtance described heron. Any knowing and willful nuanterpreUiion is subject to criminal penalty pursuant to 15 list iwi. Co nf j Jentjai
Signature and title of Authorized Official (Original Signature Required)
Signature of agent • (if applicable)
Date
Date
FORM EPA 7710-25     (Rev. 1-91)                        Page 2
-------

                                        Part I - GENERAL INFORMATION
    Section A - SUB&flTTER IDENTIFICATION
                         Mark 00 the "Confidential" box next to any subsection you daim as confidential
      Person
      Submitting  	
      Notice     ~~"
      (In US.)
                  Name at autfaccized official
 Company
                  Mailing address (number and street)
                  City, State, ZIP Code
  b.  Agent Of
     applicable)

                  Company
                  Mailing
              (number and atnet)
Qty, State, ZIP Code
. . I—
Telephone ,
1
Area Coda ! Number
I .
I
   c If you are submitting this notice as part of a Joint submission, mask 00 this box,
    Joint
    Submitter
   Of applicable)
Name of authorized official
                 Company
                 Mailing addm (number and street)
                 dry. State, ZIP Code
  2. Technical
     Contact
     OnUS.)
                 Cooipmy
                 dry. State, ZIP Cod*
3.  If you have had a prenc«oeoaBm»unic«4ian(POcorKsniiiigthia notice
   and EPA assigned a PC Number to the notice, enter the number.
                                                                     Mark (X)
                                                                     If i
4.  If you have submitted an ejuuipikiii itottce/applicBtfon for
   the chemical substance covered by this notice, enter *e exemption
   number assigned by EPA. If you have withdrawn a previously
   submitted PMN enter the PMN number.
                                                                      Mark 00
                                                                      if i
S.  If you have submitted a bcna fide request for the chemical substance
   covered by this notice, enter the bona fide request number assigned
   by EPA.
                                                                      Mark 00
                                                                      if i
    •ype of Notice-Mark (X)
I   I  Manufacture

n
                            Only

                            Binding Option
                            Mark(x)
                                                                         n
BmdfngOptton  '
Mark(x)
n
                                                                                                              Both
 FORM EPA 7710-25  (Rev. 1-91)
                                      Page3
-------

                       Part I  - GENERAL INFORMATION - Continued
 Section B - CHEMICAL IDENTITY INFORMATION
Complete either item 1 (Class 1 or 2 sobstanccs) or 2 (
If another person wffl submit chemical identity Informal
Identify the name* conpany* and address of that persoi
1. Claas lor 2 chemical substances (for HrflntMnns of daas land da
a. Oass of substance -Mark 00 1 [""[ Oastl or
Polymers) as appropriate. Complete all other items.
ion for you (for either item lor 2). mark 00 the box at theright r— i
in a continuation sheet ^ I— J
iw 2 nbf tsif wt sn the Instnietkme ManoaD
2 j^J Class 2
b. Chendcalna]ne(preteaMyCASorIUPACnomend>hae)

Confi-
dential


  c Molecular formula and CAS Regbtry Number Of known)
                                                                  CAS*
d. FaradaMlsubstanaa.pravideastruetunldUs7»m. For a dasa 2 substsnea - (1) Us* thai immediate precursor substances with their ;
                                           hireoftfaereacttonortiim'>M Q) tedkstB the ra
                                           representative' strucnffal diagrap of possiUsX
     respective CAS Regtatry Numbers. (2)Desaibethenahireoftfaereacttonortiim'>M Q) tedkstB the range of oompositton and the
     typtosl conposilloii (wnen ipprffpTifit^j (4i Provide a
l~i Mark 00 this box if you attach a continuation sheet
FORM EPA 771025  (Rev. 1-91)                           page4
-------
                            Part I -GENERAL INFORMATION-Continued
   Section B-CHEMICAL IDENTITY INFORMATION  - Continued
   Polynm (For • deaidttm of polymer. Me the Inatracttaa* Mano«L)
a. Indicate (he number-averaga Krtght of the lo
                                           st molecula
                                                   eight ccmpoaittOB of the polymer you Intend to manufacture.
 Indicate maximum weight percent of low molecular weight spedes (not tndiidtag Kridiial ntoncoien. icKtan* OT nfento) below
 500 and below 1,000 absolute molecular weight of that coaipoattion. Describe the methods of measurement qr the basts for yoar
                GPCQ    OteQ
                                                                                                               Confi-
                                                                                                               dential
           . anaxomun weight % below 500

            iiiiiiiiiiiin miijii i iniim innn
    I Mark (X)tMa box if you attach a continuation
                                         gpedfy)
                                      Wrigte
 b. You must make separate <


                                                                                            id residual
                                                                                   MI UK the manufacture of the polyiner.
Information. Mark 00 the "Confidential* box next tony item you daim as confidentiaL
(1) - Provide the chemical name and CAS Registry Number of each monomer or other react
(2) - Mark 00 this column if entry in column 0) to confidential.
(3) •• Indicate the typical weight percent of each monomer or other readant hi the polyiner.
(4) - Mark (X) the Identity comma If yoa want a monomer or other reactantoacd at two weight percent or lew to be Uated M part of the
     polymer description oa the T5CA Chemical Snhrtmce laventory.
(S) - Mark (X) this column if entries In columns O) and (4) an confidential.
(6) - Indicate the nuudmam weight percent of cadi monomer or ether reactant that may be present as a residual to the polymer a»

(7) - Mark 00 thto column if entry in column (6) to confidential.
Monomer or other reactant and CAS Registry Number
                                                                Confi-
                                                                dential
                                                                  (2)
                                                                      Typical
                                                                       tpod
                                                                        (3)
                                                                                  Identity
                                                                                  MarkOO
                                                                                     (4)
Confl-
dential
  (5)
                                                                                             (6)
Confi-
 mtfa
  (7)
|   |  Mark (X)u^ box if you attach a connmiatian
c  Provide ai
                                  i of the polyiner, if paanble
    Mark 00 thto box if you attach a continuation
FORM EPA 7710-25  (Rev. 1-91)
                                                     PageS
-------
                          Parti - GENERAL INFORMATION - Continued
   Section B- CHEMICAL IDENTITY INFORMATION - Continued
   o»
 PnvtabUMCAS
                                      totMpnMrttata*
                                                                               tec

                                                                              «*.
                                      Impurity and CAS Registry Number
                                                                                                (b)
                                                                                                  Coafl-
 n
I^Mvfe AA fthiA ^MW If VMI ^M^tf4k • tfWlMlMVflMtfHk
           -Enter any syncnymB for the new
                                             dentified In subsection 1 or 2.
     Mark 00 das box if you ettecn a
  IracteUentificetian-Us* trade names for the i
                                                                 lot 2.
                     BWi. K. t*^ TBT
                                     l^Btity to confldtiUi^ you murtpto^id»« generic cfagniaJ name for your substance
|  |  mtfk 00 this boot If you flttttdi 41 conomttttoB MMA
7. Bypradvcta — 1
                coatrnt PJpHdt ma CAS Itegtolry Number U
                                                          le; or dbpeMl of the new chemical substance at sites
                                Bypiodiicl
                                  O)
                                                                           CAS Registry Number
                                                                                  CD
Confi-
dential
     M«k(X)u^bc«tfyc«attaehaeBiianu«ncjnsheet
 FORM EPA 7710-25 (Rw.1-91)
                                              Page 6
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                         Part I - GENERAL INFORMATION - Continued
  Section C - PRODUCTION, IMPORT, AND USE INFORMATION
                           MvkOO the "Confidential* box next to any item you daim as confidential
 i. Pnxliniiun vohuna -•
   the maximum i
•duetto
memaxin«i«prcttonewt^tu^^ato&\&titfam*tJan. Mark 00 the "Canfldenttal'Box next to any item you
   daim as confidential.
  a. (1)-Describe each Intended category of uaeof the new cheoiical substance by hoictkn and application.
    (Z) - Mark 00 thto column if entry in column 0) to confidential business information (CBD.
    (3) - Indicate your wfllingness to have the information provided to column (1) binding.
    (4) - Estimate the percent of total production for the Bnt three yem devoted to each category of use.
    (5) - Mark (X) this column tf entry In column (4) to confidential buain«s» Information (CBD.
    (6) - Estimate the percent of the new substance aa fonnulated in mixtuna, suspenakxHkemul3iom.9ohaton9t or gels as manufactured
        for commercial purposes at sites under your central awodated with each categcryof uac.
    (7) - Mark (X) this column tf entry in column (6) to confidential busmcat information (CBD.
    (8)-Mvk(X)whetner the uMbrit»4iiiUted, industrial con^                    Mark mow than one box if appropriate.'Mark
                                                                                  m
                                                                       Mark 00 aypmyilaie column(s)
                                                                                  (8)	
                                                                                                  Indus-
                                                                                                  trial
                                                                                        Conv
                                                                                        meffda]
                                                                                    linding
                                                                                    Option
                                                                                                                      CBI
                                                                                                                      (9)
 •If you have identified • "consuma'' uae, pktaw provide on • continuMioa slwet a detailed deacrirxkmc^th«uae(s) of this
 chemical substance in omiumBi product*. In addition include esdmates of the concentmUon of the new chemkal substance as
 expected in consumer pnfacfa and detcribe the chemical reactkms by whkh this wbrtance loses to kien^
 product.

 DMark 00 ihto box if yon attKh • <
  b. Generic
   If you
   category. Reed* the
              use dtacftption in atibBBctton2a. ascoDndeBtfjav
                 Maaoal for exanpto of generic use "
O Mark (X) this box if you attach a continuation sheet
X Hazarftafonnatk»-uidudem me rwttce a ooe^o*rease«wbta facsimile of any hazard
  or other information which will be provided to any person who is reasonably likely to be
  equipment or practices for the safe handling, transport use, or disposal of the new si
n Mark 00 this box if you attach hazard information.
                                                            tagsto
                                                          sit label material safety data sheet.
                                                    to thto substance regarding protective
                                                  List in part 01 hazard information you ndude.
                                                                                                  ttokCO
FORM EPA 7710-25  (Rev.l-»l)
                                           Pag*7
-------
I	Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

^Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER	

| Complete Mctfoa A lor each type of nwnafactnn, practwiac, or OM operation Involving th« a«w «fa«mieil
  substance at industrial rites yoa control                 	
                               Marie 00 the XonadenttaT box next to my item you data as confidential.
 1. Operation
    •. Ucnttly •• Enl0 tK0 kiflinfjr of ttM site M wnidi tlw o|npfi>t|Teal gngti>*T^B>*-
       (2) Provide the klen^, the appraximtfa weight (l>ykg/d^y or kg/batch), and m
          sotvenBJt and catalysov etcX
       (3) Identify by number the points of restase to the envlrumneHt of the*new rtinnUiil i
      Mark 00 thto box if you attach a continuation sheet
 FORM EPA 7710-25  (Rev. 1-91)                                   Page«
-------
          Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
t» Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER - Continued
   Occupational Exposure - You mat make separate confidentiality claims for the description of worker •cttvlty.phyricrifbnn of th« new chemkal
   bubttance, number of workers expand, and miratton of activity. Mvk 00 the )nflnu.t aMengmeertag controls used to protect workers.
                                              itial business faiforaiaoon (CBI).
                        _ .   at and engineering <
(4)«M(6)-IndkateyouwilHiiyMteh«v«thelnn»iMtloBpccMdedlncbhHnn<3) or (5) binding.
(5)-Indicate the physical ibnnW of the i                 «"	
                                                    9 at the ttme of
  (7)-Mark 00 this column if en try mcchmin (5) to confidential business
  (8) — Estimate the maximum number of woikas involved in each activity.
  (9) - Mark'OO this column if entry m cohmn (8) to confidential busta
 (10) and (11) - Estimate the maximum duration of the activity for any
 (12)-MarkOOlhiscolumnifentiiaincohmuM(10)and(11) araocn
                                          (CBD.

                                          i (CBI).
                                    in hours per day and
                                                                           asr
          Worker activity

               0)
                               CBI

                               O)
                    O)
                                    W
                                                           J41
                                                                Phyatcal
                                                                fonXs)
                                                                  (5)
                                                    W
                                                                         (61
CBI

JZL
                                                           Worken
CBI

g)
                                                                                                   Maximum duration
Mrs/day
Diyi/yr
  nil
CBI

n?)
      MatkOQthtobo»tfyc«attachacontlnuatton
  X Ea
            tlRelc
IDUponl- You must make separate
   -       -       - -
                                                                       for the release number and the amount of the new
  (1) — Enter the number of cadi rcneac point identified In nw PTOOEBB deacription« pvt Ut ***^1*iii ^ Mbaectloo IdCSX
  O - Eaamate the amount of the new subttanoerdeaaedOOcaractly to the environment cr(b)mtooc«trol technology On kg/day or kg/batch).
  (3) - M** P0th<«<^
  (4) - Mentifymemedia(iir,land,CTWrttr)towhlchtheiiew
  (5) - a.D«9olbecontrcJ
                                                             wfflbe
                          on landy dundenflB ine disposal metnod and
       On a continuation sheet * for each site describe any additional
                                                                    wnctner tt is approved for disposal of RCXA nazardous waste.
                                                  dditional disposal methods mat will be used and whether the waste is subject to
                                        W Bfltf^B^^A Ak^ ^^^^^«^A ^^&^^^^A ^^ ik^ ^^kM^^^^B^^^^ft m^^^m l^^^^^J ^— -^ ^ nl 11 imun /!•> 1»J* /*!•••%
                                        D. BSBBBSSB me smoiiiiT naessea •> m> emmMiiBHH aner control Mcnnoiogy un Kg/aayj.

                                      to wser. rVami uupjiiy NPDBS (Maooasl Pc
  (Q - Mark 00 tMs cohmtn if entries in

       dlschergen or NPDES numbtrs of the POIW (Pubndy C^^Twetaem W«ks). Mark (X) if tne POTW
                                                                                                or WDESfUconfldentlai
                                                                                                         (5b)
                                                                                                                    CBl\
7) Mark (X) the
lestinationW of
Blesses to water.
                    POTW provide name(s) below:
                                              CBI
                                                          Navigable
                                                          waterway
                                                 Q  Oncr-Spedfy
                                                                                                     NPDESf
                                                                                                                 CBI
   I"] Mark 00 mis box if you attach • continuation sheet
 FORM EPA 7710-25  (Rev. 1-91)
                                                    Pegs*
-------

       Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued

  Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS      ~
                                         I Involving IMIMWC
                               I flpOEftttOn tBVOlVlng DM1MW (
                               to«MMdto)ad alter OMitumbv of ritei
                                 in
  (l)-DUgmtn«au^uattop«llanftepsaMctankalcanv«rion». GftllMdlagmn,ld«tofybyk*ter«dbftefl
  U» - Pravld* the identity, the •Mfntauti wight (by kg/diy or kg/brteh),«d«ntrypototfarkOOtMicolum«if ayof the
                                                      .                 I^MM pobit Idntfflfld.
                                                    cnvboBBMBt cf (b) Into contiot technology to ttw •Bvnt
                                                                           InfenuHonCCBD.
 of
 ic»
»r"y
      fef
     WeriBm
                                    buto,/-
                                                   (7)
CB
                                                                        rim  nil
                                                                                     Control
                                 fl2L
en

031
(14)-Byproduct*
    MakOOthtebntfyouattechtoontinuitton
 P08MBPA771W3  OUv.1-91)
-------
               OPTIONAL POLLUTION PREVENTION INFORMATION
   b claim information in this section as confidential circle or bracket the specific information that you claim as confidential.

   this section you may provide information not reported elsewhere in this form regarding your
efforts to reduce or minimize potential risks associated with activities surrounding
manufacturing, processing, use and disposal of the PMN substance. Please include new
information pertinent to pollution prevention, including source reduction, recycling activities
and safer processes or products available due to the new chemical substance. Source reduction
includes the reduction in the amount or toxitity of chemical wastes by technological
modification, process and procedure modification, product reformulation, raw materials
substitution, and/or inventory control. Recycling refers to the reclamation of useful chemical
components from wastes that would otherwise be treated or released as air emissions or water
discharges, or land disposal. Descriptions of pollution prevention, source reduction and
recycling should emphasize potential risk reduction subsequent to compliance with existing
regulatory requirements and can be either quantitative or qualitative. The EPA is interested in
this information to assess overall net reductions in toxicity or environmental releases and
exposures, not the shifting of risks to other environmental media or non-environmental areas
(e.g., occupational or consumer exposure). In addition, information on the relative cost or
performance characteristics of the PMN substance to potential alternatives'may be provided.
All information provided in this section will be taken into consideration during  the revie*t
of this substance.	i
Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reducdapffl
the volume manufactured; (3) a reduction in the generation of waste materials thiough recycling, source reduction or other .-
means; (4) a reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product
  •fonnance, a decrease in the cost of production and/or improved operation efficiency of the new chemical substance in '
  nparison to existing chemical substances used in similar applications; or (6) the extent to which the new chemical substance
  y be a substitute for an existing substance that poses a greater overall risk to human health or the environment
   Mark (X) this box if you attach a continuation sheet
FORM EPA 77UWS   OUv. 1-91)
                                        Page 11
-------
Part III - LIST OF ATTACHMENTS



nuBibcn of cflcn AtlAChflMfic*
Mark(X}me*Gxi&ientiarboxnerttoanyattachmertiiameyM Read the butnctions Manual ft


Alnichmenf name
"-























nd
of me form to
aivepage
«
the notice
Attachment
page Humberts)
























Confi-
dential























I
LJ Mark 00 this box If you attach a continuation sheet Enter the attachment name and number. |
FORM EPA 7710-25  Otev.I-91)
Page 12
-------
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET
To assist EPA'i review at physical and chemical properties data
of the property, the unto la which the property Is measured (a*
confidential. You an not required to submit this worksheet; hoi
review and ensure that confidential Information is properly pro
your submission of teat data. This worksheet is not a substitute
Property
(•)
ViporpKSBim «j£
1***
Den* ty/Hafftve density
Sohitnliry ^
SnhiMit

s^uMlhytawrtfr ar^ip^^i^ M°9

MdtiBg tBnpcratim
Bofllng/fiibHiM4ion tampnftura 4 	 torrpraann
Spcctn
l^tf^^M^lrfAMj^M 4M*«^MeM«ft*>
uuBoaman cpnacmt
Puttdc site afatributtoo
Octanol/water pntltion coefficient
Houy s L>wf consfcuit
VoUtalizaHon from water
volitadlzath)n from mti


Flanunabflity
Explodabillty
AoSOfpttOfl /OOGCQOBnt
Other- Specify



, please complete the following worksheet for data you provide
» page of the notice on which the property appears, the value
nri'iiMaiy). and whether or not the property la claimed as
wever. EPA strongly recommends that you do «o, as it will simplify
tected. You should submit this worksheet as a supplement to
for submission of test data.
Mark 00 if
piovidcd


•


















"•*•
number
(b)











'
v>








Value
(0
Tow
g/cn3
«/L
•c
•c







" '








Confi-
dential
Mark 00
(d)





ti
=S_
-i














-------
-------
[This document has been re-keyed for improved legibility.]


MEMORANDUM

SUBJECT:  Glove Requirements for Section 5(e) drders

FROM:     A. E. Conroy II, Director
          Office of Compliance Monitoring

TO:       Addresses

     The attached  TSCA section 5 inspection  guidance  applies to
section 5(e) orders which-require the use of gloves as protective
equipment during the handling  of  the Premanufacture Notice (PMN)
chemical.    The guidelines  should  be  inserted  into  the  TSCA
Inspection  Manual, Volume  Four,  Section  5 Inspection Manual,
September, -1981 as Appendix  5 under "the heading "Documentation for
Glove Requirements in 5(e) Orders*.

     The  insert will  be  issued  with-  the  section  5(e)  order
inspection targeting- packages  for those  orders  which require the
use  of  gloves.    The  inspector  should  become  familiar  with
information during these inspections.

     The key element  of the  inspection  will be to  document the
glove  requirements as  outlined  in the insert  in addition to
determining  if  the company   is  in  compliance with  all  other
restrictions outlined  in the  section 5(e) order.   The  inspector
should  submit  the final  report- to  the Office  of  Compliance
Monitoring.     Information  in   the  report   concerning  glove
requirements will  be  forwarded  to  the  Economics  and Technology
Division of OTS for their information and review.
                     T
     These  section  S(e)  inspection  procedures  are  effective
immediately.   If" you  have any questions,  please contact Michael
Hackettt of my staff at 382-7861.

Attachment
-------
     Consent  5(e)  orders under TSCA often require that gloves be
used to prevent dermal  contact and that the  submitter  of a PMN
determine  the type of gloves  to use.  Glove  selection  is to be
based on evaluating the  permeability, penetration and degradation
of glove materials.

     There  are  2 types of  information which can  be  used to
substantiate determinations that the gloves selected are impervious
to the chemical of concern:  1)  actual  laboratory test results on
the glove material when  challenged  by the PMN  chemical (including
protocol for the test); and 2)   published results of testing glove
materials with analogues of the PMN chemical (i.e.,  chemical is in
the same chemical class  evaluated by  glove manufacturers  or other
experts).  The record documenting glove selection should  include:

     1)   an  analysis  of conditions  of  potential  dermal  contact
           (e.g. associated solvents and other chemicals, purity of
          the material)  and the duration of potential contact;

     2)   any  permeability,   penetration  and  degradation   test
          results  (and protocols)  on the,.PMN-  itself _or analogues
           (if tested by  the submitter);

     3)   any published data (on--analogues--or- the PMN) used by .the
          submitter in determining  the acceptability of the glove
          selected; and

     4)   a statement  describing the specific glove material(s)
          selected., and   th&*  reasons, for. concluding- that  the
          material (s)  will  provide  protection during., the  full
          period  .of potential, contact. ..  This statement would
          include interpretation, of. the data =in points 2  and  3 in
          terms of the conditions of exposure noted -in point 1, in
          particular reconciling and  difference-: between  chemical
          substances as tested and the substance is expected to be.
          encountered by workers (e.g., test of pure compound but
          contactiArith a. solution).

     For each 5(e) investigation where use of gloves are required,
the inspector should collect documentation  on'glove selection and
use and include this  information as an  exhibit to the  facility
inspection report.   This report should be  forwarded  to  OCM for
compliance review as soon as possible.  OCM will forward  informal
on glove selection and  use to OTS for their information and review.
-------
FABIFORM
-------
 Environmental .Pjottxiion Agoncy
IMPORTANT-
                         | tf>S form, pleaee reed the I
OMJNo 2000442O-
              U S ENVIRONMENTAL PROTECTION AGENCY
                         4O1 M Street. S.W
                      Washmon. O.C.  20480
                MANUFACTUmirS IMPORT
      PRIUMINARY AMIMMINT  INFORMATION
 This information is required under the authority at Section BUI. TOM*
 Substances Control Act. 19 U S.C. 2607
                                                                     P.O.
                                                                              NM. 20M2
                                                                                              CONTROL NUMECR
                                                                                              PERIOD COVERED
                                                                                              fROM  Me. iTt  ITO- Ma
                                IVc
                                I
                                                       I - ClRTiaiCATIOM
 TtCMNICAL CIRTIPICATtON STATIMIMT
 I hereby certify m«t. to the bnt ef my knowledge and Mat. ad information
 entered on this form is complete end sccurm  I agree to permit access to.
 •nd the copying of records by. • duly autheruod representative of the EPA
 Administrator, m accordance with the Tone Substances Control Act. to
 document any information reported here.
                                                                    Signature
                                                                                                          Date
                                                                   Name and title - Please print or type
CONCIRNINO SPA OMClOHUm Of INM1RMATIOW

Any person wrw nomts nformatien to EPA under the Prehmnary A»«M»m«nt lnfoon«ionRul«l«OCF« 7121 tfioi«o»t««r«of £P»f»gul»oon»l«OCFRP«tt 21
wrueti gown doctoiurt of luefi mtormanon Thost ragulaiions erevioi that weh oerton may. if he or rtw onrat. auen t eonhotmubrv clam eo««nng ean or «d of
mi information wommgd  Intarmmon covwrad Inr tuch • dam «ral to auakdv diiooMd by EPA oniy to tha ••lent, and by nwm of tht aroctoim. MI tonn « 40
CFR Part 2  Homravar. if no such dam acco
                                      i the nfonnanon nnnan it n racawad. EPA may make that nformaaon puoke •nihout notifying iht (ubmtter
 COMNOCMTIAUTY STATIMBHTS
                                                                    ate
                                                                          ts
                                                                                            The person ngnmg the
                                                                                   9 an information that is clamed
 Confidentiality Certification Statement attests to the truth of the following four sta
 confidential. Note that chemical substance identity may not be claimed confidential tor Una rule.

 1 . My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures.
 2. The information « not. and has not been, reeaonabty obtamabla without our consent by other parsons (other than governmental bodiaal by
   use of lagnimeto meana lather then discovery based on a showing of special need m a judicial or quaai-iudwial proceeding).
 1. The information is not pubfcdy available alaewnere. .
 4. Disclosure of the information would cause substantial harm to our co
                                                             npi
                                                                   I POSH
 CONnOMTMUTV CIRTIPICATtOM  CTATIMIMT
 l hereby certify that the Confidentiality Statements on this
 form are true aa to that information below for which I have
 asserted a confidentiality clean.
                                                              Signature
                                                                                                          Data
                                                             Name and title -
r Pert A
                                                               PettEt
CAS NO
                                                              Category name (first 1S characters)
                                                                                                                11
Chemical name (first 15 characters)

   I    I    I    I    I    I    I    I    I    I    I-   I    I    I
                                                             Inventory Form C number •
                                 D
                                     MARK THIS SOX TO CLAIM THIS SECTION COMPIOeNTMl
Name
                                                            » Pert • - I

                                                                 Q Corporate Headquarters
                                                                                                     Plant Site
Number and sweet
                                                              Name
City
                                                              Number and itreat
County
                                                             City
State
                                             ZIP cod*
                                                              State
                                                                                                           ZIP
Dun and Bradnreet number
                                                              Own and Bradstreet number (for corporate headquarter* onryl
   PertC-Ta
Name and otto
 'ataphone (Area code/numberl
                                                             r Pert O - Acfcnualadgamant
                                                               EPA will tend acknowledgement to - Name and title
                                        Q  At headquarters


                                        Q  At plant site
         771O-3S
-------
§ 712.28
                                                                          40  CFR Ch. I (7-1-91  Edition)
                                            IV - PMUMIMAMY A********* IIIFOIUMATIOH
    NOTE
                Mark the boi to the left of any item botow to el*m tha anawer to the mm aa eonhdarmal.  Report •« quantmea ei
                kilogram II keogram = 22 poundal. Enter N/A for any mm that does net apply to you: do not leave any Manka.
                                for frame 3ft. 3c. and 3d. specify the accuracy el your anewara
1 .Total quantity imported
                                                               |    | 3.Quantity manufactured far saeer uaa
      U> •.Quantity ion during manufacture
         /3b + 3e #•
                                                              J e. Quanmy in wntn Mated to
                                                                  daatfov tna cnantical
                                                                                                               kg±
      3 b.Quantny lo« to iho
         9 R
                                            kg±
                      34. Quantity m waatMnat troatod
                          to doatfov tna cnamcal
                                                                                                               kg±
              Activity
                ID
                                  Procasa eatagofy
                                        (2)
               Quantity Hutograma)
                      131
Total wortrar-noun
       141
Total wornar*
     (5)
      4 .Manuf actura of the chanucal
                                     a. Eneloaod
                                     •xCo
                                     e.Opan
      S .Otvtita uaa aa raaetant
                                     a. Eneloaod
                                     O.Opon
S.On-srte nonreectam uaa of the
  chemical subetajnce
                                     *. Enetoaad
                                     b. Convened raiaaaa
                                     e.Opan
      7.On-«ita preparation of pradueta
                                     ai Eneieaod
                                     b. CantroMad raiaaaa
                                kg
                                     o.Opan
      • .MANUFACTUflER'S PRODUCTS - Report the quantity of ma ehamcal iubttancadw youaraearaioraachof mafolloimig.
        INOU8TNIA1
        PRODUCTS
                  •, Chamieal or mntuni
                                          raiaaaa
                           AfTtClat Wllh HO f9avtM9
                    COMSUMM
                    PHOOUCTC
                                                                              d. Chamieal or murtura
                                                                                    a). Aftido witH aoma) raloaaa
                                                                                    I.  Article with no ralana
       g. Product* for aaport
 D
                                                      i - information m pan B muat Dt accurate to mrnnin I 5O%
• .CUSTOMERS' USES AND PRODUCTS -
the guariMv of tfta cnamcal luMtanca KIM your customer* uaa or
                                                                                               for each of the foHo*" .
INOUSTHIAL
• •OfMJCTal



g. Products for ••

1. Unknown eusta
•. Chanucal or mtitura


o« Afttcl8 with no ftjtotwo

rmcatconaumadaa raaetant

kg

• g
kg



COMSUMIII
PRODUCTS
IrjnmaatlBl
"




4. Chamieal or miHtuta


f. Amcla with no raiaaaa
f
»
	 r
     10. MARKET NAMES - » you ragon your cuanmarf uttt at unknoMi (ft atovai for mortthw 20% o«rh« iota) quarmr»o«et»nicii«uo»Mne«thit»ou mam,-.
        ifiportl20%cfrt«nal«nd?abo»«Ktem«fF»*«tr»«iTOTund«r»h^you(^ir<)>jitm«ch« ol the followng categories	
        a. Enelotod processes

        b. Controlled reteaaa proeaaaaa
                                                        kg  e. Open processes

                                                        kg  d. Unknown
•PA 'anil 7710-38
-------

-------
       APPENDIX A
 THURSDAY, MARCH 16, 1978
        PART V
 ENVIRONMENTAL
   PROTECTION
      AGENCY
  TOXIC SUBSTANCES
    CONTROL ACT
Statement of Interpretation and
Enforcement Policy; Notification
    of Substantial Risk
-------
 11119
                                                    Nonas
 1*540-01]

    fNVMOMMMTAL MOIKTION
             (FRLMS-SI

     TOUC WatTANGB OOMTtOt ACT

             •f
 AGENCY: Environmental  Protection
 Aceoey.
 ACTION: Statement of Interpretation
 and enforcement policy.
 SUMMARY: This action states EPA's
 Interpretation  of.  and  enforcement
 policy concerning. section Me) of the
 Toxic Substance* Control Act (T8CA)
 (90 Stat. 2029.  IS  VAC. 2607). The
 provisions of that  leeUoa  vent Into
 effect on January t. 1977.
  Section Me) states that "any pmoa
 who manufactures, processes, or dis-
 tributes In commerce a chemical sub-
 •tance or mixture and who obtain* in* .
 formation which reasonably support*
 the eonclualon that nieb substance or
 mixture preeenU a tubetantlal risk of
 injury to health or the environment
 •hall Immediately Inform the Adminis-
 trator of such Information unlea* tueh
 perm ha* actual knowledge that the
 Administrator ha* been adequately In-
 formed of such Information."
 DATES: The policy expressed In tnto
 document to In effect a* of the date of
 publication.
 FOR   FURTHER   DTPORMATIOlf
 CONTACT:
  Frank O. Kover. Assessment Divi-
  sion.  Office  of Toxic  Substances
  (WB-S57).  Environmental  Protec-
  tion Agency.  401 M  Street SW..
  Washington.  D.C. 20460.  302-735-
  2110.
SUPPLEMENTARY INFORMATION:
On September 9. 1977. the Agency pro-
posed guidance (42 PR 45202) on Its In-
terpretation of and policy concerning
the provision*  of  section «e>.  Al-
though the proposed  "guidance" was
an Interpretive rule and statement of
policy exempt from the notice and
public comment provision* of the Ad-
ministrative Procedure  Act (5 VAC.
553).  the Agency solicited  comments
on several Issue* to  make more  to-
 formed decision*. On October 11. the
 comment  period wa* extended from
 October 15 to October II. ItTT (42 PR
 34857). On November 4.1977. a supple-
 mental  notice to the  proposed guid-
 ance was published (42 PR 57744). de-
 leting the November 15 date tor  re-
 porting certain  Information obtained
 before  1977  and stating that a new
 data would be established In the final
 guidance.
  In developing  this policy statement.
 two meetings have  been held (Febru-
ary 1. 1977. and October M. 1977) with
selected representatives of  Industry
and  environmental and other  Inter-
ested  groups.  Comments  submitted
pursuant to the  February 1 meeting
were irtftnaini m the preamble to the
September 9 proposal. Over 100 writ.
ten comments have  been submitted
pursuant to the September 9 proposal
from trade associsflnns. businesses, en-
vironmental  groups,  labor  union*.
State and Federal agencies, and other
Interested  parties.  Appendix  8 de-
scribes  significant  Issues  raised  in
these comments and the Agency's re-

  The major modifications to the Sep-
tember 9 proposal are summarised In
points 1 through 7 below.
  (1) Pursuant to some  question over
the definition and nature of "guld-"
     • this document to now described
     accurately  as  a "policy
menu" It to  exempt from  the notice
and public comment provisions of the
Administrative Procedure Act. a* well
as proYiaieas  concerning delayed effec-
tive dates.
  (2) Many eommenters expressed the
view that to apply these requirements
to officers and employees of a business
organization would result in ill-consid-
ered, premature reports and would un-
fairly subject employees to  conflicting
responsibUltles  as Individual  respon-
dents and as corporate agents. Other
eommenters expressed support for the
view that certain employees have a re-
sponsibility to report pertinent Infor-
mation, and felt that the phrase "ca-
pable of  appreciating pertinent Infor-
mation" appropriately described those
employees.
  The  September 9 proposal  would
have applied section 8(e) requirements
to commercial establishments as well
ss to employees capable of appreciat-
ing pertinent Information,  but stipu-
lated enforcement priorities Intended
to encourage  corporate professing and
centralized reporting of such informa*
tlon (42 PR 43363). The Intent was to
ensure that pertinent Information  ob-
tained by employees to promptly and
appropriately considered, white mini-
        dupUcattve  or
  The Agency now feel* that
Jectlves would best be served by allow-
ing commercial m anilshments—under
certain condition* designed to ensure
full disclosure—to snnme exclusive re-
sponsibility for reporting to EPA any
substantial-risk information obtained
by  Individual officers or
Accordingly,  this  poUey
stipulates that  Individual officers and
employee* will have fully discharged
their section We) obligation* one* they
have notified the designated rupnnsl
ble company supervisor or official of
pertinent Information, provided, that
the  employing company or firm ha*
established.  Internally publicizes, and
                                      affirmatively Implements procedures
                                      governing  such notifications. These
                                      procedures,  at  a minimum, must: (D
                                      Specify the Information that  must be
                                      reported: (2) Indicate how the  notifica-
                                      tions are to be prepared and submit-
                                      ted; (3) note the Federal penalties for
                                      falling  to report:  and (4)  provide  a
                                      mechanism for  promptly notifying of-
                                      ficers and employees who have submit-
                                      ted reports of the company's dlspost-
                                      tlon of  those reports, including wheth-
                                      er or not they were submitted to EPA
                                      (and  If not. Informing employees  of
                                      their right to report to EPA. ss pro-
                                      tected  by TSCA section 23). EPA be-
                                      lieves these four criteria will ensure
                                      prompt and appropriate processing of
                                      pertinent Information.
                                        Establishment of such  procedures
                                      notwithstanding, all officials responsi-
                                      ble and having authority for the orga-
                                      nisation's execution of Its section Ue)
                                      obligation* retain personal liability for
                                      ensuring that substantial-risk informa-
                                      tion to reported to EPA.
                                        (3) The September S propou! »Uted.
                                      In Part UL that a person obtains in-
                                      formation when he to  aware that It
                                      "may suggest"  substantial  risk.  Nu-
                                      merous  eommenters  questioned  the
                                      Administrator's  authority  to  compel
                                      the reporting  of Information which
                                      "may suggest"  substantial  risk. The
                                      Administrator agrees  that section «•>
                                      addresses Information  that "reason-
                                      ably supports the conclusion" of sub-
                                      stantial risk and has deleted the "may
                                               provision,  but  cin
                                     w^wwv   BJF* vv ••Mwpsta* •»«•*  va^aa^saeavMCovgf
                                     that "reasonably supports the condu-
                                     slon" of substantial risk Is not identi-
                                     cal to a conclusive demonstration-'of
                                     substantial risk. The former typically
                                     occurs, and must be  reported, at an
                                     earlier stage.  Part VI  in this policy
                                     statement provides Agency interpreta-
                                     tion of the types of information  that
                                     "reasonably support" sucn  a condu-
                                       ct) Numerous commenten requested
                                     clarification  of  different  aspects of
                                     Part V of the September 9 proposal
                                     ("Information Which Reasonably Sup-
                                     ports  a  Conclusion  of  Substantial
                                     Risk"), particularly concerning envl-
                                     ronmental effects,  and suggested dif-
                                     ferent Interpretations  of what consti-
                                     tutes a "substantial risk". The Agency
                                     continues to focus in this policy state-
                                     ment on  the effects set forth in the
                                     September  9 proposal, but  clarifies
                                     that the  substantiality of a risk Is  a
                                     function of both the seriousness of the
                                     effect  and the probability of lu occur-
                                     rence (see Part V).
                                       (5)  Numerous  coramenters  main-
                                     tained that  section We) only  applies
                                     prospectlvely to Information obtained
                                     after January 1.1977. The Agency dis-
                                     agrees, as explained In the preamble
                                     to  the September 9   proposal  This
                                     policy statement  continues to apply
                                     section He) to tnfonrsiton obi* ned.
                                     before 1977 of which n  person  -»*•
                                     MfJKTtB. VOL 43. MO. II—TMMSAAV. MAICM le. 1*7*
-------
 been  aware since January 1. 1977. in
 response to request* for clarification,
 the statement defines what constitutes
 such awareness. In ttib manner. EPA
 intends to  limit the  need  for searches
 of historical records and files.
   (6) This  policy statement now pro-
 vides  that  any Information published
 in scientific literature.  In any lan-
 guage. Is exempt if It is referred to In
 abstracts published  by specified  ab-
 stracting services.
   <7> This  policy statement describes
 In a new Part X how to submit claims
 of confidentiality.
   Accordingly, the Administrator's In-
 terpretation of and policy towards sec-
 tion Me) is set forth below.

   Dated: February 24.1978.

                  DOUOLAS COSTU
                     Adminiitmtar.

            I. Qurtwmows

  The definitions set forth In  TSCA
 «-rtio" 3 ippiy U> these requirement*.
 In addition, the following definitions
 are provided  for  purposes  of  this
 policy statement:
  The term "manufacture or process
 •for commercial purposes'  " means to
 manufacture or process: (1) For distri-
 bution In commerce. Including for test
 marketing purposes.  (2) for use ss a
 catalyst or an intermediate. (3) for the
 exclusive use by the  manufacturer or
 processor, or (4) for product research
 and development.
  The term  "person" Includes any nat-
 ural person, corporation,  firm,  com-
 pany, joint-venture, partnership, sole
 proprietorship,  association, or any
other business entity, any State  or po-
 litical subdivision thereof, any munici-
 pality, any Interstate body and any de-
 partment, agency, or Instrumentality
 of the Federal Government.
  The term  "substantial-risk Informa-
 tion" means Information  which rea-
sonably supports the conclusion that a
chemical  substance or mixture pre-
sents a substantial risk of Injury to
 health or the environment.

     II. PKBSOBS SoajBcr to THB
            Rxqor
  Persons subject to section Me) re-
quirements  include both natural per-
sons and business entitles engaged In
manufacturing, processing, or distrib-
uting in commerce a  chemical sub-
stance or mixture. In the case of bust-
ness entitles,  the president, chief ex-
ecutive officer, and any other officers
responsible  and having authority for
the organization's execution of Its sec-
tion Me) obligations must ensure that
the  organization  reports substantial-
risk information to EPA. The business
organization is considered  to have ob-
tained any information which any of-
ficer or employee capable of appreciat-
ing  the significance of that Informa-
tion has obtained. It Is therefore In-
                                                     Nonas

                                       cumbent upon business organizations
                                       to  establish  procedures  .or expedi-
                                       tious! y processing pertinent Informa-
                                       tion In  order to  comply  with the
                                       schedule set forth in Pan IV.
                                         Those  officers and employees  of
                                       business organizations who are capa-
                                       ble of  appreciating the significance of
                                       pertinent information are also subject
                                       to these reporting  requirements.  An
                                       employing organization may relieve Its
                                       Individual officers and employees  of
                                       any  responsibility for reporting sub-
                                       stantial-risk Information  directly  to
                                       EPA by establishing. Internally publi-
                                       cizing,  and affirmatively Implementing
                                       procedures for employee submission
                                       and corporate  processing of pertinent
                                       Information. These procedures, at a
                                       minimum, must: (1) Specify the Infor-
                                       mation that officers  and  employees
                                       must submit:  (2) indicate how  such
                                       submissions  are to  be prepared and
                                       the mmpany official to whom they are
                                       to be submitted: (3) note the Federal
                                       penalties for falling to report: and (4)
                                       provide a mechanism for promptly ad-
                                       vising officers  and employees In writ-
                                       Ing of the company's disposition of the
                                       report.  Including whether or not the
                                       report  was submitted  to EPA (and  If
                                       not Informing employees of their right
                                       to report  to  EPA.  ss protected by
                                       TSCA section 23). An employee of any
                                       company  that has established *««4
                                       publicized such procedures,  who has
                                       internally submitted pertinent  Infor-
                                       mation in accordance with them, shall
                                       have discharged his section Me) obli-
                                       gation.  Establishment of  such proce-
                                       dures notwithstanding, all officials re-
                                       sponsible and having authority for the
                                       organization's execution of its section
                                       Me) obligations retain personal liabil-
                                       ity for  ensuring that the appropriate
                                            intlal*risk \ntQT*n*ttfm Is
edtoEPA.
  Business organizations that do
establish  such  procedures cannot re-
lieve their individual of fleers and em-
ployees of the responslblity for ensur-
ing that  substantial-risk Information
they obtain Is reported to EPA. While
officers and employees of such organi-
zations may also elect to submit
stantlal-rtsk information to their i
rlors for corporate processing and re-
porting, rather than to EPA directly.
they have not discharged their Individ-
ual section 8 obligation until EPA
has received the information.

  Hon.—Irrespective of a business orgsamv
Uon's jedsioB to establish and publicist the
proccnuFOB fls&wcntKdl elbow* •• to vcipMiwWto
for Becoming cognisant of any substsatlal-
risk inf omuuon obtained by IU of fleers and
employee* ind for encurtne tnai sucb Infor-
mation is reported to EPA vithia IS work-
ins days.
                                                                     11111

                                       Into possession of or knows of such In-
                                       formation.

                                        Nora,—This  Includes   Information  of
                                       •hteh a prudent penon  MmiUrly «uu*u4
                                       cowM nijonibpr as expected to •	—
                                       have I
                                        An establishment obtains Informa-
                                       tion at the  time any officer or em-
                                       ployee capable of appreciating the sig-
                                       nificance  of such Information obtains


                                       IV. Rsaoisnurr THAT * Paso* "1st-
                                                IT iNfosar THS AOMIXISTIA-
                                        With the exception of Informstlon
                                      on  emergency Incidents  of  environ-
                                      mental contamination (see Part V(c»
                                      a person has "Immediately Informed"
                                      the Administrator if Information is re-
                                      ceived by EPA not later than  the ISth
                                      working day after the date the person
                                      obtained such Information.  Supple-
                                      mentary Information generated after a
                                             Me) notification should,  !T 19-
                                                 be lstmee^£te!y  reperisd.
                                                eney incidents of  environ-
                                      mental contamination, a
                                      report the Incident to the Administra-
                                      tor by telephone  as soon  as  he has
                                      knowledge of the Incident (see Part CT
                                      for appropriate telephone contacts).
                                      The report should contain as much of
                                      the Information required by Part IX
                                      as possible. A written report In accor-
                                      dance with Part OE (a) through (f) Is
                                      to be submitted within IS days.
                                        Informstlon currently In the posses-
                                      ston of a penon who Is subject to re-
                                      porting  must be reported  within M
                                      days of publication of this policy state*
                                        V. WHAT Commons SUBSTANTIAL
                                                                              A  "substantial  risk  of Injury  to
                                                                            health or the environment" Is a risk of
                                                                            considerable concern because  of (a)
                                                                            the sfrlotismss of the effect (see Sub-
                                                                            parts (ax (b). and (e) below for an il-
                                                                            lustrative list of effects of concern).
                                                                            and (b) the factor^ probability of  its
                                                                                        ' w*******^!^ Of ettClaU
III. WHS* * Poison Wtu. BB 1
  AS HAVUO OBTAINED INFOSMATIO*

  A  penon obtains substantial-risk In-
formation at the time he first comes
flu of use. or costs of restricting use.
are not to be considered In determin-
ing whether a risk  Is "substantial".)
These two criteria are differentially
weighted for different types of effect*.
The human health effects  listed  in
Subvert (a) below, for example, are so
serious that relatively little weight is
given to exposure: the men fact the
Implicated chemical  Is In commerce
constitutes sufficient evidence of expo-
sure. In contrast, the nmalnt&g ef-
fects listed In Subverts  cb)  and 
-------
1111Z

•pendent hu actual knowledge  that
'.he Admintatntor Is already informed
of them.
  (U) Information respecting then ef.
feeu an be obtained either directly.
by observation of their occurrence, or
Inferred from declined studies u dla»
cussed in Part Vt
  The Agency eonelden effect* for
which  •ubrtantlalrflsk   Information
mutt be reported to Include the fol-
lowing;
    Human Health ejOrscts-  Any
Initance of cancer, birth defect*, mu-
tagenldty. death, or eerloua or  pro-
lonced  ineapadtaUoa. Incliidlnf the
laoi of or inability  to uee a  normal
K  Any pattern ot effects  or e*l>
dence which reaoonably support* tho
conclusion *'"«*  *hi*  chemical  sub*
•tanee or mixture can produce cancer.
mutation, birth defeett or toxic effeeta
resulting In
                      K0-U)
                                                 Nonas

                                    the above advene effect* hea been as-
                                    erlbed arid which became of the pat.
                                    tern, extent,  and amount of contain!-
                                    nation (1) aerloualy threatens human
                                    with cancer,  birth defects, mutation.
                                    death,  or eerloua or  prolonged  Inca-
                                    pacltaHon. or (3) seriously threatena
                                    non-human onanlame with lane eeale
                                    or —"Kfn^itr "e"'*1*"* population
(b>f»vf>
   id and i
              rlously
trtbutlon In
Indicated In studlsa ftMTl1"*1*^
als contained within
unknown to the
tag
ft.OOO
                      mtordnclud-
ed when coupled  wtth potential for
widespread exposure and any non-triv-
ial advene effect.
  (3)  Any  non-trivial adverse effect.
heretofore  unknown to tho
trator.  associated   with a
known to havebtoaeeumulated to
pronounced degree  or to  ba
spread In environmental i
  (4)  Eeologteall.
in species'  Interrelationships: that fa,
changes   In  populati
growth, survival,  etc.
affect other spedc
or survival.
  Example* Include: U)!
illation of  primary producers (i
maerophytea)  m
e.g.. resulting In nutrient
or eutrophtcatlon. of
terns.
  (U)  Interference wtth crtttoali
chemical cycles, wen; sa the nitrogen
cycle.
  (S)  Fadle transformation  or
dation to a chemical having an
ceptable risk as defined above.
  (c)  £mefpracy incidents of ravtron*
mental contamination-Any environ.
mental contamination by a chemical
substance or mixture to which any of
VI NATUU tan
  no* Waxen "RsASOtMSLY Sovrans
  m  Coxcwsiosr or  SussTAjrrui.
  RUB

  Information attributing any of the
effect* described In Part  V above to a
rtfi""'*1 substance or mixture I* to be
reported If It to on* of the types listed
below and If It to not exempt from the
reporting requirement by reason of
Part VU of this  policy statement. A
person to not to delay reporting until
he obtains conclusive information that
a —"•-•"•*••' risk exist*,  but to to Inv
rsport  any evtdeose which
            supports** that conclusion.
               win generally not bo
          as to HIT substantiality of
the rtotc It should, however, reliably
       the effect to the chemtral.
                     the  fa
                    the
       in Part V will often
ably support** a conclusion of i
tial ftsfc-ConsMsratlon of
Uve Information before
only occur where It to Indicated I
  (1) Ztasrtoacd. controlled stvdtnx to
assessing the quality of
the respondent to  to i
It contains reliable evidence
the effect to the chemical. Not only
should final results from such studies
be reported, but  also preliminary re-
sults from Incomplete studies
                                                                            piece of information, constitute repor-
                                                                            table information: an  example would
                                                                            be a group of exposed  worsen experi-
                                                                            encing doziness together with prelimi-
                                                                            nary experimental results demonstrafc.
                                                                            Ing neurological dysfunctions.
                                                                             Reports and studies of undesigned
                                                                            circumstance* Include:
                                                                             (I) Medical and health surveys.
                                                                             (II) Clinical studies.
                                                                            jlll)  Reports concerning  and  evt-
                                                                            dence of effects In consumers, workers.
                                                                            or the environment.

                                                                            VII. lavoasunoa' Wrnoi MSB Nor Bi
                                                                           Information need not be reported If
                                                                         It
                                                                           (ail
                                                                         ports:
                                                                           (bi
                                                                                                 I by BPA In re-
                                                                                             Bitted In writing to
                                                                         EPA pursuant to mandatory reporting
                                                                         requirements  under  T8CA  or  any
                                                                         other authority administered by EPA
                                                                         itjff\ntMttf  t||^  Federal  Insecticide.
                                                                         PungteMe and Rodenttdde Act. the
                                                                         dean Air Act. the Federal Water Pol-
                                                                         lution Control Act. the Marine Pratec*
                                                                                        and Sanctuaries  Act.
                                                  periments and testa.
                                    lee Include:
                                     (!) In vivo <  .
                                     (U) to vitro experiments and
                                    Consideration may be given to the ex-
                                    istence of corroborative Information. If
                                    necessary to  reasonably support the
                                    '••ntftM-*'"' that a chemical present* a
                                    substantial risk.
                                            .
                                       (tv ) Environmental monitoring
                                      lea.
                                       (2)  Jteports eoacerninff and stadias
                                      of  andetiaiud,  mieontrolled  rtfr»m-
                                      •unecs. It Is anticipated here that re-
                                      portable effect* will generally occur In
                                      a pattern, where a significant mmmon
                                      feature Is exposure to the chemical.
                                      However, a single instance of cancer.
                                      birth defect*, mutation, death, or seri-
                                      ous IncapedtaUon  In a human would
                                      be  reportable  If  one  (or  a  few)
                                      chemical(s) was strongly  Implicated.
                                      In  addition. It Is possible that effeeta
                                      less serious than  those described In
                                      Part V(a) may be preliminary manifes-
                                      tations of  the more serious  effect*
                                      and. together with another triggering
the Safe Drinking Water Act. and the
Resource Conservation TT***  Recovery
Act),  provided that the  Information:
(1) EtiennmassBS that required by Part
IZ (c) through (fX and (2) to  from now

stratnts set forth In Part IV  and Iden-
tified as a section Me) notice In i
dance wtth Part DBbk
  (e) Has been published In the i	.-_
Ufta literature and referenced by thai
         abstract servtees: (1) Agrie>
      (2)  Biological  Abstracts.  (».
          Abstracts. (4)  Dissertation
         . (6) Index Medleua.  (6) Na-
tional Technical Information Service.
  (d)  I* corroborative of well-estab*
       advene  effects already docu-
        in the scientific literature and
             described In 'c> above..
              Information  concerns
          Incidents of environmental
                            In Part
VfeKor
  (e)  I* •"Hrt*'"*'* In  notification of
sputa under section  311(bX5> of the
Federal Water Pollution Control Act.

                                 SY
                                                                                           Past
                                                                                     Pasoa TO
                                                                           DATSorTSCA

                                                                           Any  substantial  risk  Information
                                                                         possessed by a peraon prior to January
                                                                         1.1977. of which he la aware after that
                                                                         date shall be reported within 60 days
                                                                         of publication of this policy statement.
                                                                         The Agency considers that a person I*
                                                                         "aware" oft
                                                                           (a) Any Information reviewed after
                                                                         January  1.  1977.  including not only
                                                                         written report*, memoranda and other
                                                                         document* examined arter January 1.
                                                                          1977. but also Information referred to
                                                                         In  discussions  and  conferences  In
                                                                         which  the  person participated  after
                                                                         January 1.1977:
                                             VOC 41 NO. M-TMUMOAV. MAICN I*. Iff!
-------
                                                    Nonas
                                                                                                         inn
   (b) Any Information the content! of
 which a penon has been alerted to by
 iUte received after January 1.1977. la-
 cludlai say laformattoB conceminff a
 chemical for which the penon to pres-
 ently  mreilin  health  and  environ-
 mental effects;
   (c> Any other Information of which
 the penon hae actual knowledge.
     IZ.R0oarnra
  Notlcea  thall  be delivered  to  the
 Document Control Officer. Chemical
Information  Division. Office of Toxic
Substances (WH-A97). Environmental
Protection Agency. 401 Bl Street SW..
Washington. D.C. 20460.  /••••*•>
  A notice should:        <•     >
  (a) Be sent by certified malL or In
any other way permitting verification
of Its receipt by the Agency.
  (b) State that it  to be'ng submitted
la accordance with section We).
  (c) Contain the Job title, name, ad-
dress, telephone number, and signa-
ture of  the penon reporting sad  the
name tsA address of the msauf
lag. prnnfisslnj. or  distributing
Itohmeat with which he to associated.
  (d) Identify the chemical substance
or mixture (Including. If *""•",  the
CAS Rettstry Number).
  (e> summartse the adverse effects
beiat reported,  rtfecrlnlng  the nature
and  the extent of the risk Involved,
  (f) Contain the specific source of the
Information together with a summary
and the source of any available sup-
  Far
                Incidents of i	
                     (see Part VMM.
  »_^^^^^^_
  person
the  **—J-fc*-^» by  telephone  as
soon as he has knowledge of the Inci-
dent (see below for appropriate tele*
phone contacts). The report should
contain as much of the information re-
quired by Instructions (b) through 
above as possible. A written report. In

through (f) above,  to to be submitted
within  19  days.  Twenty-four  hour
emergency telephone numbers i
 cut. Viragos.
 •lure). SIT
 cftaa n (New York, New
 Rfce. Vtrtm TiliniHT Ml
       Ql (
 Vlrttnle, Maryland.
 Columbia). 31*417
R«ftoa IV
         . Louisiana). 114-14
        VU  (Ne
       •>. sis-m-ms.
       vm (Colorado.  Ulan.    .
  Montana. North Dakota, gouth Dakota).
  im ITT issft
Rcctaa IZ  (California,  Nevada,
  Hawaii. Guam). 413-SM-63S4.
C
 ****
         See  NOTE on last page
                                        Alaska). MS-44S-1MO.

                                           JC CoimaswruuTT Cum

                                        (a) Any person submitting a notloe
                                      to EPA  under section Me) of TSCA
                                      may assert a  business confidentiality
                                      claim covering all or part of the Infor-
                                      mation contained In the notice. Any
                                      Information covered by a claim will bo
                                      disclosed by EPA only to the extant.
                                      and by means of the procedures, set
                                      forth la 40 CPU Part a (41 FR 36MB.
                                      September 1.1976).
                                        (b) If  no claim  accompanies  the
                                      notice at  the  time It to submitted to
                                      EPA. the notice will be placed in an
                                      open file to be available to  the publte
                                      without further notice to the submit-
                                      ter.
                                         throusb ((> of
  within IS dare to
    '. Chemical In-
                                                                           formation DtvMon, Office of Tone But-
                                                                                I (WH-Mlt. 401 M Street gW* Wash-
                                                                                .D.CM4I
                                                                                                        be held
                                                                           subject to these  requirements, since: <•>
                                                                           They only have a partial role In the manu-
                                                                           facture, mmieslne. or distribution of cnemi-
                                                                           calf, (b) to other sections of TSCA. the term
                                                                           ••psfeea  who manufactures.  praeeeM*.  or
                                                                           distributee" chemicals clearly refers to buii-
                                                                           ness orsantcauone; "persons" should be con
                                                                           dstently defined, and  the appilcmnon at
                                                                           criminal penalties mandates a strict
                                                                           pKtatlon of this word.
of Appendix  A
UOUTem. VOC 4X NO. S1-TMUSSOAV. MAICN 14. IffTO
-------
11114                                                  NOTKfS
               A«ency considers that dlf-   mation they hare obtained directly to O»A;   (corporate  uiuirtalng.  mailing.  holiday*.
fercnt section*  of TSCA. having dlffcrtnt   rmtlMr. their dlcnt manufacturer*. preeet-   etc.).
purpose*. arc appropriately directed to dlf-   eon and distributor*  art resnnnelhl*  for     Jtaspoa**; The Agency ha* changed the
(erent respond**!*  In  UM cat* of tectton   importing such Information.                 nomplmnro period to IS business days. It \»
S. officer* and employee* oho are capable                  _ _    _             Imperative that procedure* be established (o
of appreciating  the significance of tntorma-       •• twj -oafanmm  or orroejune*       expedite the reporting of nibiuntial-ruk In-
lion have a letUlmau  rttpontlblllty to be     coeimeac 1- The -nay suggeer criterion   formation, not that reporting conform  to
alert to and report substantial-risk Inf em*,   ta PMtm of UM propeaal •ertei toaeapel   txtoUng praeedurea.
turn.  The guidance  bat been modified eo   rurUMr MuminaUonotlnformaUon Utatby     Cbwwiemf 1* Allow from JO to M day* for
that natural  penon tad buatnttt enutlee    utifii noi rjfrtrrt iff ttttloo lui rsnulie   too teoond phatt of reporun* alurnau»«ly.
2SJS211 "TtSSStSS 2X£:£   aStk" SSSSr, tan**.. eJSrS   «•_•« *-*» * *~ U»tt for
different way*. afoot oineen ana empioyeto   ••••••mabia nianatl  data not manoft thsa.
                                                      luelf. The former typically
can discharge their ttcilaa «e> obligation*  MtrUMrilak iMMmment often requires any*     ftaowr Saving deleted  the "may tug-
by lubgutunt pertinent Information to cor-  •here  from montht to several  yearaof   •*"" criurton. the Agency sect no need to
poraio superior*.  provided that the  com-  aJXf -fur  preliminary remit* ••MOM"   provMt a second phate to the reporting
pany  hat established the  risk-evaluation  Sfcr.7~.St... uj.7 it^g —-..XSZL.   period. Supplemental  Information that It
procedural characurtMd In Part O. In the  netted.          • "•• "•"•»    r        fflllrltBM Jwuary I. lOTT post-
have the overview necessary to reach con-  chitton ofsubttiAUaTrttlsnot MtuHtil to   P •"•"•' " reportlm substantial-risk in-
sideted. well-supportod dedslooa. Corporate  u^enclu
  JUipowe; The Acency considers that em-     commttt K The statement, in Part OX of
ployeet have a lesiUmate role la risk report-   ^^ proposal that a penon ha* nhttlntd to-     Oammsa:! It The reporttnc of -any In-
Inc  It It Imperative that risfc Information   formation If be -. . . should know of the o»   stance- of cancer, birth defect*, etc.  in
obtained by  employee* bo appropriately   m  obligations must ensure that the orga.   taformation. The Agency further jonsldrr*.   mtTountaaiotho obligation to report them
nisatlon  reportt  substantial-risk  Informs,   howw. iha*  -knom- formation  t>   JtheTs^iWt-d^curBo™.
UontoCPA.                «.«u«— ...   «••"• »»«««*•• •««««* • Piwmwi Ptnoo     JUspoatar The Agency agree*.
  Comment J- Clarify wh'*fc^!°'*".*r*   imUlarly situated could  reasonably bo em-     cummsal 1C How are reportable data dta-
covered. Md UM imtnt of U^roMlgailon,   .,,,., „ ^a,,.  MegUgono* or mtMUtonal   tlnoutabed from routine teau  including
Are employee* ••capable of appreciating per'   avoidance of information doot not absolve a   *m^» — - ••eh aa
                 -                                                                """I~B"*!I1 — •
,ln«t mformauon-- by virtu. -rj-J-or  ZZZ?Z,^£Z«.TZfiXXriXi  TMtpwarnVroTpoUcV 'statement direcu
ta!?!!!r?t!fcAJ?J?*5J£m?. £?£££  m »»» •*• BO***** «• eiprem tbot* p>  UM i sporting of specified effect* when via-
subject to these requlrementa. or Jutt juper-  (.Btiefm,   __                 «.*_  know to UM Admlninrator. Many routine
                                                                am can otot whoa  teat* an baatd on a knowledge of toxicity
                                                                 of risk Inform*-  aaaKtated with a chemical: unknown effect*
                                                               I to an understand   ueuirrlng during such a range test mm have
                                         lag of the Implication! of UM Information:  to he reported It they are thoe* of concern
                                         -obtains" should bo defined la term* of pea.  to UM Agency tad If UM information raeeu
                                               i of information and awareaam of IU  the criteria set forth la Pan* v and vi.
                                          	..                                    OBmtmji It  The moot  widespread • in
                                           Jterpoiu*; The  ••obtaining" of Information  *ttro~ utt to UM Amet ten. whicn  is luoieu
                                          jecurs via person* who are "capable of ap-  to [•••Kllislils debate. Clarify the eircum-
                                         preetatlng the tlgnlftranre of pertinent h>  stincoa undtr which positive resulu of  m
                                         formation.-  There will likely bo  dram-  vttro toat* must be reported.
                                         stance* in which the evaluation of taforma*    llmao***  Pan VI clartfica thai the n-
                                         tion clartfle* It* full Import: the establish,  porting of m  vitro ten* will depend upon
                     H
  com\SrfiT^v^^-   »>» ^~  •• • ™« • ™ — - — ——	
lacVsh^uld notb*woJect uTuZm^wuZ   nclent to determine whether Information   ronmental  EffeeW). Peralsunce ana
tob* should not oo auaject w «— I^UBW   ^^^ _^^ minttr wbMauai risk should   accumulation should  be eonsiderm

  Jtomriur  Contractor* tad  Independent   be reported: it I* even iMufflrtent to aoeenv   only whoa coupled with tomldty aod i r-.i-
lab*ar«noi  responsible for reporting infor-   modau normal procedural time constraint*   cant exposure.



                                                  VOL 0. ItO. n-TMUtSOAT. MAIOt «*. l«7l
-------
                                                           NOTICIS
                                                                                                                        11115
       (or
             Part V now clarifies those ef.
           •Men reporting depends upon a
   	exposure +btefnlaL Persistence
 by Itaalf la no longer Itemised as a report-
 able effect but rather la considered to be a
 component of  exposure, potential: It may
 also underlie the measurements described in
 Pan VtbHi). Laboratory Indicators of pro-
 nounced btoaecumulatlon are to be reported
 when coupled with potential for widespread
 exposure and any non-trivial adverse effect.
   Comment if: The  n-ocuaol/water parti.
 Uon coefficient addresses a physico-chemi-
 cal property, not btotogtcal effects, and la
 not alone an indicator of substantial risk:
 further, the values stated tar the coefficient
 aad the MBonrtmiiilatlon factor la fUh  do

   ffispeasa- The Agency acknowledges  the
 numerical error and has "••Mr** the values
 to correspond. This  policy statement now
 djraeu  ^ reportiagjtf_ an  experimental

 eoupjed with an adverse effect aad potential

   Comment II: The requirement that Infer-
      , which "links" an effect to a chem>
              t la too broad and contradicts
                language  of
           ' The Agency hat provided In a
          VI Its Inurprtutlon of "reason-
ably tupponi".
  Cbesmenf fir A determination that Infer-
                 ily supports  the  eooclu-
     ' of —*-»--•'-• rink cannot bo made in-
            of considerations of uao "itrpe.
                 aaner of uslag a chemical
     Influence the occurrence of an effect:
la particular, the criteria ahould reflect a
                               i that the
                        of a "substantial
                i to a chemical are  tho
          i of the effect, aad ibi total expo-
             ", The method and manner of
               I Is one of several f acton de-
termining Ita exposure  potential.  Aa de-
scribed in Part V.  the Importance of expo-
sure potential aa a component of "substan-
tial nak" depends upon the kind of effect of
concern. Thusi the effacta described In Pan
V(ai are  ao senoua  that relatively little
weight to given to exposure: the effacta de-
scribed la Parts V   aad (c» Involve a sig-
nificant exposure or exposure potential.
  The Agency further considers that a defi-
nition  of "normal* use  for  a  particular
chemical will often depend upon a  kaowi.
      of   the rtska assoclaisd  with  the
 8.1

  Comment  Its  Information
•dentlfto literature la la
English should be
tummary form by ahstn
the accuracy of English
and
                           If publlahadla
                            of foreign Ut-
          : This policy
vMaa that Information
uric uieratura. whether la
other language, la exempt fi
           In
                                  rung if
                              by  certain
ipedfled abstract services.
  Comment II: Information exchange sya»
tema with other Federal agendea should be
Immediately established ao that respondents
need not report to EPA Information already
reported to other  Agendea. and vice versa.
Such dupllcatlve reports are unduly burden-
                                             Rnpoiue: EPA' is coordinating this  pro-
                                            tram with other sgenciei now.  When  thai
                                            coordination Is successfully  completed, the
                                            policy statement will be imtndid to exempt
                                            from the reporting requirement Information
                                            that has been submitted to  other sped/led
                                            agencies. In the meantime, substantial-risk
                                            Information must be reported directly to
                                            EPA: such a report does not discharge  any
                                            reporting obligation to other i
                                                     srrxcTiva MTB or teca
                                             Comment  it The tense of the verb "ob-
                                           tains" reveals that section ate) waa Intended
                                           to be applied  prospectlvely to Information
                                           newly acquired after January 1. l»TT. CUllaa
                                           section Kd)  or other rules to acquire Infor-
                                           mation obtained before then.
                                             JterpoM*- AI dlaniassd la the [mamma to
                                           the September • proposal, "«* Agency nn-
                                           sldera section Mel to apply to risk taforma>
                                           Uon possessed by or known to a
                                           before, on. or after January L II
                                           cemlng Informatloa first
                                           IBTT. this policy statement eoaUauea to re-
                                           quire  reporting of Information received If a>
                                           person has been aware of i: daca January t>
                                           I97T. for the reasons rttscuseed la the 8ep-
                                           Umber 9 preamble.
                                             Comnwnl  It The term "aware"  la too
                                           vague to be of any help la ••T""'""H  to
                                           these  requirements. Since many
                                           employees are potentially  subject to
                                           requirements,  aad given uncertainty over
                                           the extent to which they ought to be aware
                                           of pre-liTT information, this provision tsnrta
                                           to compel the very file search It waa Intend
                                           ed to  avoid. The  term "aware" should be
                                           further defined, possibly la ^TIJM of actual
                                           knowledge.
                                             Kttfontf The Agency In Part vm of thai
                                           policy statement now defines the pre-im
                                           Informatloa of which a petaoa la t
                                           to be aware.
   Comment It Clarify whether these  re-
 quirements apply to chemicals previously
 but no longer  manufactured, processed, or
 distributed m commerce by a person,
   jteipnees,' Information  outlined before
 If" must be  reported If the  person haa
 bean aware of  It ataee January  1. im. as
 prescribed by Part VTJL Concerning chemi-
 cals which a person haa discontinued manu-
 facturing, prnnsmlng. or distributing  Unco
 January  U  irrT.   Information  ntitained
 before the time of dlaoontlauation to subject
 to those roqulrementa. It to expected that
 the  onmitoHlon of  Information  after that
 Uma will be minimal: however, should addi-
 tional informstloB be acquired, it may trig-
 ger the reporting Imrrlhia la Part vm
  Comment Mr Clarify the meaning of "sub-
 staaual rtsk"  relative  to other  risks ad-
 dressed by TSCA.
  /Ufaoaor A substantial risk to  defined la
 Part V  *
therefore, are subject to TSCA. Tr-   -
                                  FfOMAL MOUTH. VOC 43. NO. M-TMUaSOAY. MAICM <*. )•*•
-------
line                                       Nonas
                cMt mulUMM u M CFK 1O.4 tra imnifc   production of t food, food •ddMlvo.
                (cat vita tali *ttv.                    eoemoue. or dene*.
                 COMMMIU Jt AM inuraedtaiM tod CM*.    Cemmtmt i* rmpioyom ihould tavt tho
                Inu Intended eoleif f or UM in UM produe*   opuoa to wbmtt mporu monrmniMir
                uen of • food, food additive. drug. eocnetlc    I?
                denaltieiM  of lh« PFDCA provtdo  taM   PMTOM  M  ilojchbid la Put tt la otdor to
                              whlta vt Innnrtort for   oMoMtah Uwt Meb pinoni ta*o dtael
                UM M • ooapoiMat of • food, f ood oddltlf*.   UMtr nnilntlnn« ud la ofdor to 
-------
-------
       TSCA Section 8(e) Reporting Guide
                      June 1991
  PICT TO APKIHIflTRATOR OF BUBBTAMTIAL RISKB. Any person
who manufactures, [imports,] processes, or distributes in
commerce a chemical substance or mixture and who obtains
information which reasonably supports the conclusion that
such substance or mixture presents a substantial risk of
injury to  health or  the environment shall immediately
inform the  [EPA] Administrator of such information unless
such person has actual  knowledge that the Administrator
has been adequately informed  of such information.


— Section «(e). Toxic  Substances control Aet  (1976)
              Office of Toxic Substances
      Office of Pesticides and Toxic Substances
         U.S. Environmental Protection Agency
               Washington, D.C.  20460
-------
                             preface

This "reporting guide" has been compiled by EPA's Office of Toxic
Substances (OTS) to assist potential respondents who manufacture,
import, process or distribute chemical substances in complying with
Section 8 (e) , the substantial  risk information reporting provision
of the Toxic Substances Control Act (TSCA) .

There are two major objectives for presenting this guide.  First,
the guide will make certain information pertaining  to Section 8(e)
reporting even more accessible to  members of  the the regulated
community and others.  Second, the guide will provide reference to
both general and specific examples of submitted information as well
as EPA's  comments regarding such submissions. v  The examples are
intended to h^lp persons who are subject to Section  8(e) understand
better the types of information that should be submitted  to the
Agency under this very important mandatory hazard/risk information
reporting provision of TSCA.

Most of this TSCA Section  8(e) reporting guide is presented in a
basic question and answer  format reflecting primarily  the most
common questions  asked about  Section  8(e) of TSCA.  In addition,
this reporting guide contains EPA's comments  regarding  the TSCA
Section 8(e)-applicability/raportability of a number of toxicologic
•case studies" provided by the Chemical Manufacturers Association
(CMA) .  The guide also contains an  index of Section 8(e) "status
reports" reflecting Section 8(e)  reporting guidance (Appendix A)
and an index  of all status, reports prepared  to date arranged by
submitted information, type. (Appendix B) .

EPA recommends that this TSCA  Section 8(e) reporting guide be used
as a tool in conjunction with EPA's March 16, 1978, Section 8(e)
policy statement ("Statement  of  Interpretation  and Enforcement
Policy; Notification of Substantial Risk"  43 FR 11110).. EPA's TSCA
Section 8(e)  policy statement  is included as Appendix C at the back
of this reporting guide. Also included is  Appendix O which^contains
a copy of a February 1, 1991 Federal  Register notice that announced
EPA's TSCA Section 8(e) "Compliance Audit Program" (CAP) and copies
of EPA's April 26, 1991 and encoded June 20, 1991 Federal Beaiater
notices announcing certain modifications  to the CAP.

This reporting guide is being distributed publicly through the TSCA
Assistance Information Service (TSCA Hotline)  in the Environmental
Assistance Division (EAO/OTS) ... Persons wishing to obtain a copy of
the guide should contact the TSCA  Hotline. The  telephone numbers,
telefax numbers  and/or addresses  of the  TSCA Hotline, other EPA
Offices,  and ether organizations  cited throughout this guide are
presented for the reader's convenience on the next few pages.
                        Charles M. Auer, Director
                        Existing Chemical Assessment Division/OTS
-------
T8CX
               Phone:    (202) 554-1404


               Telefax:  (202) 554-5603
               Address:  TSCA Assistance Information Service
                         Environmental Assistance Division
                         Office of Toxic Substances (TS-799)
                         U.S. Environmental Protection Agency
                         401 "M" street, s.w.
                         Washington, D.C.  20460
V8GX fl.flafei.aB. Bfa) fiaomABfe 9raaAflfli.ua CflBfeAP
               Address:  Docuaent Processing Center  (TS-790)
                         (Attn: Section 8(e) Coordinator)
                         Office of Toxic Substances
                         U.S. Environmental Protection Agency
                         401 "M* street, S.W.
                         Washington, D.C.  20460
   f Yaiup In£azBAfei.OBH  fVTTl Doomifliifc 97oaflflfli.ua
               Address:  Document Processing Center (TS-790)
                         (Attn: FYZ Coordinator)
                         Office of Toxic Substances
                         U.S. Environmental Protection Agency
                         401 "M" Street, S.W.
                         Washington, D.C.  20460
               Mamex     Michel Stewart

               Phone:    (202) 382-3532
                         (202) 260-1532  (after 8/24/91)

                                ii
-------
                                    fCBXt
         Address:    confidential Data Branch
                     Information Management Division
                     Office of Toxic Substances
                     U.S. Environmental Protection Agency
                     401 »M» Street, S.W.
                     Washington, D.C. 20460
           Phone:     (202) 475-7425
                      (202) 260-0425  (after 8/24/91)
           N
                      David Willi
           Phone:     (202) 382-3468
                      (202) 260-3468  (after 8/24/91)
Coordi.na.fcoi
           N
                      Jacqueline Favilla
           Phone:     (202) 475-8823
                      (202) 260-8823  (after  8/24/91)
                     OTS Public Docket
                     Room 6-004, NorthBast Mall
                     U.S. Environmental Protection Agency
                     401 "M" Street S.W.
                     Washington, D.C.  20460
Hours of Operation:
                     8-12 and  1-4 Monday through Friday
                         (Closed on Federal Holidays)
                           iii
-------
Address:  Freedom of Information Office (A-101)
          U.S. Environmental Protection Agency
          401 "M" Street, S.W.
          Washington, D.C.  20460

      s:  Office of Compliance Monitoring (EN-342)
          U.S. Environmental Protection Agency
          401 "M" Street, S.W.
          Washington, D.C,  20460
Phone:    (202) 382-3807
          (202) 260-3807 (after 8/24/91)
Address:  Pesticides and Toxic Substances Division
          Office of General Counsel (LB-132-P)
          U.S. Environmental Protection Agency
          401 "M" Street, S.W.
          Washington, D.C.  20460
Phone:    (202) 382-7505
          (202) 260-7505 (after 8/24/91)

          Pesticides and Toxics Enforcement Division
          Office of Enforcement (LE-134-P)
          O.S. Environmental Protection Agency
          401 "M" street, S.W.
          Washington, D.C.  20460
Phone:    (202) 475-8690
          (202) 260-8690 (after 8/24/91)
                 iv
-------
National
          Toll-Free:
                   (800)  424-8802
          Local:
                   (202)  426-2675
rlanal  oftlam
                           r Miana
     Region 1
     Region 2
     Region 3
     Region 4
     Region 5
          (617)  223-7265
          (201)  548-6730
          (215)  597-9893
          (404)  347-4062
          (312)  353-2318
Region' 6
Region 7
Region 8
Region 9
(214)  655-2222
(913)  236-3778
(303)  293-1793
(415)  744-2000
Region 10   (206) 442-1263
     BAl Va.eliai.aAl.  TB£amafci.aH Barviea
             Iress:   National Technical Information Service (NTIS)
                     U.S.  Department of Commerce
                     5285  Port Royal Road
                     Springfield,  Virginia 22161
          Phone:
              (703)  487-4600
Bafeianal
           a€
          Address:   National Library of Medicine
                     U.S.  Department of Health and Human Services
                     8600  Roclcville Pike
                     Bethesda, Maryland  20894
          Phone:
              (301)  496-6193
-------
Addr*MS
Phon«:
    ical Information Symt
             Inc.
7215 York Road
Baltimore, Maryland
                               21212
(800) CIS-USER

(301) 321-8440
(Toll-Pr««)

(Local)
                      vi
-------
                            Contents

Pref mom	   i
     important addresses and Telephone Numbers	  ii

Reporting Under Section • (•) of TSCA	   1
     What is the Statutory Language of TSCA Section 8(•)?....   1
     Why is Section 8(•)  Reporting  Important?	   l
     How was EPA1* Section 8(e) Policy Statement Developed? ..   l
     What is "Substantial Risk" Information? 	   2
     Who is Subject to Section 8(e) Reporting?	   3
     What Chemicals are Subject to  Section 8(e) Reporting? ...   5
     What does the Term "Obtains Information" Mean?	   6
     What are the Sources Of 8(e)-Reportable Information? ....   7
     What Information is Not Reportable Under Section 8(e)7 ..   8
     How does 8(e) Relate to Section 4, 5 4 8(d) Reporting? ..  10
     Does a "For Your  Information"  Notice Satisfy 8 (e) ?	  10
     Does Reporting to Another Agency Satisfy 8 (e) ?	  11
     When Must Section 8 (e)  Information be Reported to EPA? ..  11
     Where Must Section 8 (e) Information be Reported?	  12
     Row Must Section 8(e)  Information be Reported?	  13
     How can Confidential Data be Claimed/Sent Under 8(e)? ...  14
     How does EPA Track/Identify Section 8 (e) Notices?	  14
     How does OTS Review/Use Section 8(e) Information? .......  15
     Do Status Reports Represent EPA*s Bottom-Line on Risk? ..  19
     Has EPA Issued Other Section'8(e) Reporting Guidance? ...  20

                               vii
-------
Reporting under Section 8(e) of TSCA  (Continued)
     How can the Public Obtain Section 8(e) Submissions?	  24
     Is there a Section 8(e) Enforcement Response Policy? ....  25
     Has EPA Taken Formal Section 8 (e) Enforcement Actions?  ..  27
     Does 8(e) Implementation Encourage Pollution Prevention?  27
Case Studies	  29
  A. Numerical Reporting Guidance for Lethality Information  ..  29
  B. Acute Tests with Non-Lethal Neurobehavioral Findings ....  31
  C. Skin/Eye Irritation and Skin Sensitization Tests	  34
  D. Subchronic Toxicity	  36
index of 8 (e) status Reports Containing Polioy/Ouidaaee	  39
  I. Toxioologioal/Zxposure Findings	  39
     A.   Acute Toxicity (animal)  	  39
     B.   Acute Toxicity (human)  	  39
     C.   Subacute Toxicity (animal)  	  40
     D.   Immunotoxicity (animal)	  40
     E.   Neurotoxicity (animal)	  40
     F.   Neurotoxicity (human)	••	«...	  40
                        »t
     6.   Oncogenicity (animal)	•«	  40
     H.   Oncogenicity (human)	  41
     I.   Reproduetive/Oevelopaental Toxicity (animal)	  41
     J.   Reproductive/Developmental Toxicity (human)  	  41
     X.   Genotoxicity (in vitro)  	  41
     L.   Genotoxicity (in vivo)	  42
                               viii
-------
 I. Toxicplogical/Bxpoiure Finding* (Continued)
    M.   Aquatic Toxicity/Bioeoncantration ..................  42
    N.   Emergency incidents of Environmental Contamination .  42
    O.   General (NonEmergency) Environmental Contamination .  42
ZZ. Oeaeral Section • (e) Reporting Issues ...................  42
    A.   Zntracorporate Reporting Procedures ................  42
    B.   Subject Persons ....................................  43
    C.   Subject Chemicals ..................................  43
    D.   Research & Development Chemicals ...................  43
    E.   Drug Export ........................................  43
    F.   Pesticide Export  ...................................  43
    6.   Previous Hanufacture/Zmport/Process/Distribution  ...  44
    H.   Obtaining Information ..............................  44
    Z.   Pre-1977 Information .................. . ............  44
    J.   Actual Knowledge  by EPA  ............................  44
    K.   Published Scientific Literature ....................  45
    L.   Information Obtained from Other Federal Agencies  ...  45
    M.   Information Corroborating Well-Established Effects .  45
    N.   Relationship to Other TSCA Reporting Requirements . .  45
    O.   Relationship to Other EPA Administered Authorities .  46
    P.   Relationship to Non-EPA  Administered Authorities  ...  46
    Q.   Section 8 (e)  Reporting Procedures ..................  47
        m
    Index of All flection S(e)  Status Reports
    Arranged by Submitted Information Type	  49
                              ix
-------
APPSNDTX C
     T8CA ••etion • (•) Policy stataaaat	  91
         (March 16, 1978; 43 FR 11110)

          Yaeaaioal AMadaaat eitatiea	  98
          (May 29, 1987; 52 FR 20083)
     MCA laatioa •(•) caapliaaoa Audit Program Hotie*  .......  99
                   (Fabruary 1, 1991; 56 FR 4128)


           CenplitA9« Audit Prograa Medifieatieaa	104
                   ;April 2S, 1S91; 55 FR 19514)


           Coapliaao* Audit Pregraa Medif ieatieaa	107
              (aneodad varaion Juna 20, 1991; 56-FR Part XV)
     Support Zazoraatiotti for Coalidaatialit? eiaia»t»	in
-------
	        	JOTOM lAMOUXgg Of TSCX BBCTTQH 8(B)7

Section 8 (•) of the Toxic Substances Control Act (TSCA) states that
•any person who Manufactures [including  imports],  processes,  or
distributes  in coaaerce a chemical substance  or  mixture and who
obtains infomation which reasonably supports the conclusion that
such substance or mixture presents a substantial risk of injury to
health  or  the environment  shall  immediately- inform the [EPA]
Administrator  of  such information unless such person  has actual
knowledge that the Administrator has  been adequately informed of
such information." [90 Stat. 2029, 15 U.S.C. 2607(a)]
    TS aseTTOM a tsi
Zn general, EPA considers Section 8(e) of TSCA to be a critically
important  information gathering  tool that  serves as  an "early
warning* mechanism  for keeping the  Agency and others apprised of
new-found serious chemical hazards and/or exposures; Section 8(e)
data are extremely valuable input for the hazard identification and
risk assessment activities within and outside EPA.
		ifl SHCTTOlt Sf»> POIiICT BTATEMBMT PBVBTiOPBD?

The Section 8(e) information reporting requirement took effect on
January 1, 1977, the effective date of TSCA.  Although Section 8(e)
contains  self-implementing  reporting requirements,  EPA  sought
public comment and input in order to make more informed decisions
regarding implementation of  Section 8(e).   Following receipt and
consideration of numerous public comments on  a September 9, 1977
proposed policy statement, EPA published its March 16, 1978 final
Section 8(e)  policy statement ("Statement  of Interpretation and
Enforcement Policy; Notification of Substantial Risk" 43 FEDERAL
REGISTER lino).  The 1978 policy statement  clarifies the types of
information that are  required  for  submission  under Section 8(e),
and describes the procedures  for reporting such information to EPA.
A minor technical amendment  to  EPA*s 1978 TSCA Section 8(e) policy
statement involved a  change  in the address  to which Section 8(e)
notices are to be sent (52 FEDERAL REGISTER 20083; Nay 29, 1987) .
For easy  referral  when using this  reporting  guide,  the Agency's
Section 8(e)  policy statement has been reproduced as Appendix C at
the back of the guide.
-------
•HAT IS HgOBaTMITIAL RISK*  TOTQ^MATIOH?

The term "substantial risk" information refers to that information
which reasonably supports a conclusion that the subject chemical or
mixture presents a substantial  risk of injury to  health or the
environment ; however,  such information need not and  most typically
does not establish conclusively  that a substantial  risk exists.

Zn deciding whether information is "substantial risk" information,
one must consider 1) the seriousness of the adverse  effect, and 2)
the fact or probability of the effect's occurrence.   Zn determining
TSCA Section  8(e)-applicability/reportability, these two criteria
should be  weighted  differently depending upon the  seriousness of
tae^effeet or the' extent ef the-exposure,' i.e., the more serious
the effect, the less heavily one should weigh  actual or potential
exposure,  and vice versa.   For example,  in  cases  where serious
effects such as birth defects or  cancer (as  evidenced by benign
and/or  malignant tumors)  are  observed, the  mere  fact  that the
implicated chemical is  in  commerce (including chemicals  at the
research and development stage) constitutes sufficient evidence of
exposure to submit the new-found toxicity data.

EPA has also received numerous Section 8(e) submissions alerting
the Agency that chemical substances already known to be capable of
causing serious health and/or environmental effects were detected
in significant amounts in environmental media  (e.g., soil, surface
waters, groundvatar, air (including workplace  air))  or in products
not known  previously by"the Agency to contain  such  chemicals.  Zn
such cases,  the discovery  of  previously unknown  and significant
human and/or  environmental  exposure, when combined  with knowledge
that the subject chemical  is  already  recognized  or suspected as
being capable of causing serious adverse  health  effects (e.g.,
cancer, birtbr defects,  neurotoxicity)  or  serious  environmental
effects (e.g., non-trivial  aquatic species toxicity), can provide
a sufficient  basis  to report the  new-found exposure  data to EPA
under Section 8(e) of TSCA.

The decision-making process for  Section 8 (e)-reportability should
focus primarily  on  whether the  toxicity or exposure information
offers reasonable support  for a  conclusion  of substantial risk
under the criteria described above, but should net focus at all on
whether the  information is- conclusive regarding  the ~ risk.   A
        •Substantial risk" information must be reported to EPA
unless the subject person has actual knowledge that the Agency
has been adequately informed of such information.  A detailed
discussion of the> types of information about which EPA considers
itself to be adequately informed is presented on Page 8 of this
reporting guide under WHM IOTQRMATIOM is BO* MPQRTMU
BBCTTQH SI«I7
-------
decision-to  report information to the Agency  under Section 8(e)
should  not involve exhaustive  health and/or  environmental risk
assessments  of the  subject chemical(s).    Further,  determining
reasonable support for a conclusion of substantial risk should not
include any evaluation of either the economic or social benefits of
the use(s) of the subject chemical substance(s).  Finally, deter-
mining whether reasonable support exists  for "substantial risk" is
not synonymous with the determination of  an  "unreasonable risk" as
that term is used elsewhere in TSCA.
For the purposes of Section  8(e),  the term "person" includes the
following: any natural  person,  corporation,  firm,  company, sole-
proprietorship, joint-venture,  partnership,  association,  or any
other business  entity,  any  State  or political subdivision  of a
State, any municipality, any  interstate body,  and any department or
agency of the Federal Government.

Such "persons" are subject to TSCA  Section  8(e) only to the extent
they are engaged in commercial  activities  involving manufacture,
importation, processing or distribution of chemical substances or
mixtures under the jurisdiction of TSCA and  therefore covered by
Section 8(«).£.of JTSCA. .. While it is clear-'that entities such as
labor unions', trade associations, contract testing laboratories and
agencies of  the Federal Government are "persons"  covered by TSCA
Section 8(e), the mandatory obligation to report substantial risk
information  is  incurred only to the  extent,.that  the  entity is.
engaged commercially  in manufacturing,  importing,  processing or
distribution  of  the  chemical  substance, or  mixture  about which
substantial risk information  is obtained; however, these particular
entities are not typically involved in such commercial activities.

Under Section 8(e), there are no exemptions' for small businesses,
small production or importation volumes, or commercial activities
such as manufacture for export only or research and development.
However, Section 8(e)  does not require a subject person to submit
information about a chemical substance or mixture that the person
does not manufacture,  import, process or distribute commercially.
Further, a person who  obtains substantial risk information about a
chemical or mixture that the person did at one time, but does not
any longer, manufacture, import, process or distribute in commerce,
is not required to submit the information under Section 8(e).

Despite these limitations  in coverage, EPA has received numerous
Section 8(e) submissions  from respondents  who obtained otherwise
reportable Section 8(e)  information but for some technical reason
did not have any statutory obligation to submit the  information to
EPA pursuant to Section 8(e).  EPA believes that such submissions
are of significant benefit, in many cases,  to others who currently
-------
handle  the subject chemical(s) and who can take actions that are
designed generally or specifically to reduce or eliminate health or
environmental  hazards/risks.   A formal TSCA Section 8(e)  or "For
Your Information" (FYX) notice under these circumstances is a clear
demonstration  of the respondent's stewardship.  EPA encourages and
welcomes these technically voluntary submissions either pursuant to
Section 8(e) or oa  an  FYX basis.

Xn  implementing Section 8(e)  of TSCA,  EPA strives to ensure that
pertinent  information  is reviewed promptly, and given appropriate
consideration, by subject persons for  submission to EPA, while at
the same time  minimizing duplicative  or ill-considered notices.
The Agency believes these objectives are served best by.allowing
commercial establishments to assume the exclusive responsibility to
submit  substantial risk information that is obtained by individual
employees  and  officials.  Accordingly, SPA's Section 8(e) policy
statement explains that individual officers/employees are viewed as
having  discharged  their individual Section 8(e) responsibilities
once they notify a designatedrsupervisor or official in full about
pertinent  information, provided that the employing' entity has an
established, internally publicized and affirmatively implemented
procedure governing such notices.   The Agency's Section 8(e) policy
statement  specifies that such procedures, at a minimum, must:

  (1) specify the information  that must be reported;

  (2) indicate  hoy-,, the; reports, are „to be  prepared and^ submitted
     internally i ~~

  (3) note  the  Federal  civil and criminal penalties for failure to
     report substantial  risk  information; and

  (4) provide a mechanism for the timely notification of officers
     and employees  who submitted  reports about the disposition of
     those reports. Such notification  should inform the reporting
     employee/officer" as to  whether or not  the  information was
     submitted to EPA, and if not,  inform the employee or officer
     of their protected right  (under Section 23 of  TSCA) to report
     the information directly to  EPA.

The Agency believes that the above procedures, serve to ensure
prompt  and appropriate;''processing and consideration^ of ' pertinent
information by persons subject to Section 8(e) of TSCA.   Xt is
important to note, however, that despite the  establishment of such
procedures, those employees and officers who are  responsible for
actual  management  of  the organizations's  Section 8(e) reporting
obligations retain personal  civil and/or  criminal liability for
ensuring that  substantial  risk information is submitted to the
Agency.  Xa the absence of such  established internal procedures,
all employees and officers retain their individual responsibilities
and liabilities for ensuring  that substantial risk information is
reported to EPA.
-------
                 B BITftTgCT TO flECTIQM 8      PORTIHQ?
Chemicals "not under TSCA jurisdiction and therefor* not covered by
Section 8(e) are discussed in Section 3 of TSCA and include:

  (1) pesticides (as defined in the Federal Insecticide, Fungicide
     and Rodenticide Act (FIFRA) )  when aanufactured, processed, or
     distributed in commerce for use as a pesticide;

  (2) tobacco and tobacco products;

  (3) source materials, special nuclear materials and byproducts (as
     defined in the  1954 Atomic  Energy Act (ASA) and  regulations
     issued under the AEA) ;

  (4) foods,  food additives,  drugs,  cosmetics,  and  devices (as
     defined in the  Federal  Food,  Drug and Cosmetic Act  (FFDCA))
     when manufactured, processed or distributed in commerce  as a
     food, food additive, drug, cosmetic or device.

Except for those chemicals specifically excluded by definition from
TSCA jurisdiction, Section 8(e)  of TSCA pertains to all  chemical
substances and mixtures including but not limited to the following:

  (1) research  and development  (R&D)  chemicals  (including those
     intended  for use as pesticides prior to application for an
     Experimental Use Permit (EOF) or a  registration under FZFRA) ;

  (2) laboratory reagents;

  (3) lew volume chemicals;

  (4) polymers;

  (5) chemicals that are manufactured solely for export;

  (6) intermediates (including non-isolated intermediates
                    as well as pesticide intermediates) ;
  (7) catalysts;

  ( 8 ) byproducts ;

  (9) impurities;

(10) TSCA-covered microorganisms and products therefrom.

Specifically with regard to "pesticides," a chemical substance that
is manufactured, processed or distributed in  commerce  aolalv as  a
pesticide is excluded by Section 3 of TSCA from TSCA  regulation.
However, a ohemioal substance vhioh is  ia the process  of  research
and development (RiD) as a pesticide  is subject to TSCA un£U •ueh
time as the  manufacturer or importer  demonstrates the iateat to
-------
produce a pesticide by submitting- to the Agency an application for
aa "Experimental  Use Permit"  (BUP)  or registration under FXFRA.
For further information about this TSCA/FIFRA jurisdictional issue,
the reader  is directed to EPA's  initial  TSCA Chemical Substance
Inventory reporting  regulation (43 PR 64585; December 23,  1977;
Appendix A Comment 37, 38  and 39)  and the 1986 amendments to the
TSCA Section  5 •Premanufacture Notification Rule"  (51 FR 15098;
April 22, 1986).   Prior to the FIFRA EUP or registration stage,
such R&O materials are chemical substances under the jurisdiction
of TSCA including Section 8(e).

Zt is important to note also that vhile some rules promulgated by
EPA under other sections of TSCA,  or under other authorities which
are administered  by  EPA, may  exempt certain  chemical substances
and/or mixtures or certain types of commercial  activities,  such
exemptions typically apply only to  the rule issued by the Agency
and not to TSCA in general or Section 8(e) of TSCA specifically.
	po«s ma CTBM MQBTXCTB IMTQUMXTTQ:   	

Section 8(e)  pertains to information that a  person possesses or
about which the  person knows.   The Section 8(e) policy statement
explains that an establishment obtains information at the time any
officer or employee' who is capable of appreciating' the significance
of the-information-obtains that information." "Known" information
includes that information about which a~ prudentjperson of similar
training* job function, etc., could be reasonably expected to know;
Although Section 8(e)~of TSCA-does not compel" subject persons to
actively-search  for reportable information or to undertake extra-
ordinary efforts to retrieve reportable information, negligence or
the intentional avoidance of information does  not absolve a person
of his/her  individual Section 8(e)  reporting obligations*.   TSCA
Section 8 (e)-reportable information that is "obtained" by a company
includes:

       a) information  obtained before  January  1, 1977
          and reviewed after January 1, 1977, but prior
          to  March 16,  1978  (the  publication  date of
          EPA's TSCA Section 8(e) policy statement);

       b) information  obtained for  the  first time after
          January 1, 1977 but before March 16,  1978; or

       c) information  obtained by  the  company  for the
          first time after March 16, 1978.

     HQXEt For information regarding the specific time frames
     for reporting such "obtained"  information, the reader's
         ntion is
     attention  is  directed to  wmt MPBT TBCA BBCTTQM
     IOTORMXTIOM B« MPOMm TO  EPA? on Page 11 of this guide.
-------
With regard to a), b) and c) on the preceding page, section 8(e)-
reportable information includes not only written reports, Memoranda
and other- such documents examined after January 1, 1977, but also
information referred to in formal or informal discussions and con-
ferences in which a company participated after January 1, 1977.

Specifically with regard to a nubile scientific conference/meeting,
visually or verbally obtained information  from such a meeting la
subject to Section 8(e) reporting imlcaa the obtained information
is captured accurately/adequately in a meeting transcript, abstract
or other such  written record or document that  is to be formally
released to the public within a reasonable time  frame.  Information
obtained from a privata conference or meeting,  however, should be
considered for reporting under Section 8(e)  within 15 working days.
             son            TOM a—
TSCA Section 8(e)-reportable information can come from a variety of
sources  including,  but not  limited to  draft,  interim  or final
written reports (including study reports,  letters, telegrams, telex
reports) or verbal reports  (received at meetings or by phone) that
involve observations (including preliminary observations)  from, for
example, controlled or uncontrolled:

 (1) human or animal studies/events ( including but not limited to
     studies/events that involve high dose levels or non-routine
     routes of exposure); or

 (2) environmental  events/ studies  (including but hot  limited to
     aquatic toxicity studies,  bioaccumulation  studies,  chemical
     monitoring studies  (supplemented  if need  be by information
     derived from computer modeling studies based  on  actual or
     reasonably anticipated chemical exposures and exposure-related
     parameters) )  .  It is important to note, however,  that modeling
     studies, including those based solely on theoretical exposure
     data (e.g. , "worst-case"  scenarios) , are me£ considered by EPA
     to be sufficient in and of themselves to meet  the Section  8(e)
     reporting requirements.   Further, environmental or health  risk
     assessments (including those using computer modeling) based on
     either  1)  theoretical  exposure data,  or 2)  actual exposure
     data submitted on a mandatory  basis under an BPA-administered
     statute typically need as£ be reported under Section  8(e) .

The evidence that offers reasonable support for  a conclusion of
substantial  risk  need not  be complete nor definitive but  should
provide a plausible link between 1)  an observed  serious effect and
one or few chemicals (e.g., in a discrete process/operation) , or 2)
a specific product/activity and a previously unrecognized exposure
to  a  chemical  that is  known or reasonably anticipated  to cause
serious adverse health or environmental effects.
-------
EPA1 a March 16, 1978 Section 8(«) policy statement  ("Statement of
Interpretation'and Enforcament Policy; Notification  of Substantial
Risk" 43 FR 11110) also raquires immediate  reporting of "Emergency
Incidents of  Environmental  Contamination"  (EXEC).   \n EXEC ia an
environmental contamination (accidental or intenticr.al in nature)
involving a chemical known  to be a aerious human or environmental
toxicant and which because of the extent, pattern and amount of the
contamination  (1)  seriously threatens humans  with  cancer,  birth
defects, mutation,  death or serious  or prolonged  incapacitation
(e.g.,  neurotoxicologic  effects,  serious  reproductive  system
effects),  or  (2)  seriously threatens non-human organisms  with
large-scale or ecologically significant population  deatruction.
                 IS MM MPQRTXBM IMPM BBCTTOM a
Tber«  er« ««v«ral  kinds of  information  about vh:    the Agency
considers itself to be adequately informed already f   the purposes
of Section 8(e) of TSCA.  For example, information   .at otherwise
meets the criteria for Section 8 (eX reporting need ncs-be submitted
   the information meets one  or more of the following criteria:

 (1) is contained in an EPA study or report.

 (2) is published in the open scientific literature.

 (3) has  been submitted; - already -to*- EPA -under -'another^ mandatory
     reporting proviaion of-1)  TSCA, or* 2-)  somer- other authority
     that is administered by  EPA.

 (4) is  contained  in a  formal  publication/report  or a formal
     statement made available to  the general public by another
     Federal agency.

 (5) is corroborative (in terms of, for example, route of exposure,
     dose, species, time to onset, severity, species,  strain, etc.)
     of a well-eetablieBed adverse effect.
        is..importanfc-to-notav* however,  that-information -that newly
     identifies a serious  toxic effect at a lover dose level for
     example, or nun flies a-serious effect that, was previously-only
     suspeoted, is  no£- considered by EPA to be corroborative and
     should be reported under Section  8(e) of TSCA.
                           •3
 (6) is information for which  the EPA Administrator has waived
     compliance] with TSCA  in general or Section 8(e)  specifically
     upon a  request and determination of the President  of the
     United States that such a waiver  is required in  the interest
     of the  national  defense;  Section 22 of TSCA  outlines the
     procedures by which such waivers  are  to be requested/issued.


                                 8
-------
With regard to item  (2)  on the preceding page,  EPA believes that
for the purposes of Section 8(e) reporting, a subject person need
not report: information that is obtained from well-established/well-
recognized scientific journals, such as those typically abstracted
in a) major computerized abstract  data  bases,  or 2) publications
such as current content* published  by  the Institute  for Scientific
Information (ISI), Inc.  (Philadelphia, Pennsylvania).  Similarly,
information that is obtained  from na^r  U.S.  news publications
(e.g., newspapers or news magazines with national circulation) or
nationally broadcast U.S.   radio and/or television news reports
typically need not be submitted to  EPA under Section 8(e) of TSCA.
However, with  regard to information  obtained  from lesser known
scientific journals, or from other  magazines, newspapers, radio or
television reports,  a subject person must have actual knowledge
that EPA has been adequately informed about such information.

Specifically with regard to item (3) on the preceding page, it is
clear that  information submitted  or  otherwise  formally reported
(vithin 15 working days of obtaining the information) pursuant to
a mandatory reporting requirement of a statute administered by EPA
need mot be  submitted duplicatively under Section  8(e)  of TSCA.
Part VII(b) of EPA's March 16, 1978 Section 8(e) policy statement
is illustrative in that it  provides a  list  of only a few such EPA-
administered statutes.  The following is a more current list of the
statutes administered by EPA.
               Toxic Substances Control Act (TSCA)

   Federal  Insecticide,  Fungicide and Rodenticide Act (FX7RA)

                       Clean Air Act  (CAA)

                      Clean Water Act  (CWA)

                  Safe Drinking Water Act (8DWA)

           Federal Water Pollution Control Act (TWPCA)

     Marine Protection, Research and Sanctuaries Act  (MPR8A)

          Resource Conservation and Recovery Act  (RCRA)

        RCRA Hazardous and Solid Waste Amendments (H8WA)

              Comprehensive Environmental Response,	
             isation and  Liability Act (CBRCLA;  8BPBR7UVD)
         Superfund Amendments Reauthorization Act  (SARA)
-------
Specifically  with regard  to item  (4)  on Page  8,  it  saunflt be
automatically'assumed that the Agency has been adequately informed
about information in a report or study by another Federal or other
governmental  agency  if the report or study has not been formally
published or otherwise released to the general public.  Therefore,
if a person obtains (i.e., possesses  or knows  of),  for example,
certain  unpublished Section  8(e)-reportable information  from a
study that is conducted by or for an agency of the U.S. Government
(other than EPA), that person must consider the need to immediately
submit those  findings under Section 8(e).  Since 1977,  EPA has
received a  number of Section 8(e)  notices  filed by companies who
had obtained  unpublished results of studies conducted  by or for
other Federal or other governmental agencies.  Zn most cases, such
submissions are limited to 1-2 pages  and  the Agency immediately
establishes direct contact with the responsible agency to minimize
or eliminate the company's Section 8(a)  reporting burden.
sow noKfl erst Bszjtn *o vaex aBGVTOHS 4. s & afnt
                                                  MPORTOQ?

The TSCA Section 8 (e) reporting requirement applies to "substantial
risk" information  obtained during any study conducted under TSCA
Sections 4 or 5, or any study "listed" under TSCA Section 8(d) as
being underway unleae such information is otherwise required to be
reported immediately to EPA under 1) Sections 4, 5 or 8(d) of TSCA,
2) some other'section'of TSCA, or 3) some other authority that is
administered by EPA.   To date,  the Agency has received numerous
TSCA Section 8(e) notices concerning.the interim results of studies
conducted pursuant to Sections  4 or  5 of TSCA,  or  listed under
Section 8(d) of TSCA.  The Section 8(e) reporting that took place
in these  instances typically occurred because the  obligation to
report under Section 8(e)  was  incurred ..before  reporting  of the
study findings was required under Sections 4,  5 or 8(d)  of TSCA.
Zf other  required reporting occurs before or ooiaeideatal with
incurring a  Section 8(e)  reporting obligation,  that information
does not need to be reported also under Section 8(e) of TSCA.  This
exemption does not change substantially the Section 8(e) reporting
obligation;  it  is designed merely to avoid, duplicative notices
except in cases where timeliness considerations become paramount.
POM A «>CM TQPB TUTQBMXTTOM* BPBMXflBIQM BMTBTT • f«l BgQPTRAKgHTfl?

Section 8(e)-reportable information submitted to EPA on a "For Your
Information" (FYX) basis does ns£ satisfy the requirements for the
submission  of  information under Section 8(e).   TSCA Section 8(e)
information must  be reported to EPA  in full accordance with the
procedures  outlined in Part  IX of  the Agency's March 16, 1978
Section  8(e)  policy statement  ("Statement  of Interpretation and
Enforcement Policy; Notification of Substantial Risk"  43 FR 11110)

                                10
-------
and its technical amendment  (52 FR 20083).  The TSCA Section 8(e)
policy statement/technical  amendment appear at the  back of this
reporting-guide as Appendix C.  in addition, the reader's attention
is directed to W^TEM HHST BBCTIOM >f*l lOTORMXTloii BH MP9RTEP? and

Page 13 of this reporting guide, respectively.  Finally, it should
be noted that EPA's Office of Compliance Monitoring (OCX/OPTS) has
issued a  nuaber  of  "Notices  of Non-Compliance" to companies that
have submitted TSCA Section 8(e)-reportable information in a timely
•anner but simply on an PYZ  basis  and not  under Section 8(e).  For
further information with regard to  EPA's enforcement activities
relating  to TSCA Section 8(e), the reader's attention  is directed
alSO tO  HM BPA  TMJftlf yORMXIi SECTIOII  8 f •!  BHMRCBMBMT ACTIONS?
which can be found on Page 27 of this reporting guide.
	TO AffQ/nBR AQBMCT BATI8FT gBCTIQlf B (Hi	

Mandatory or other reporting of information to another agency does
na£ satisfy a company's obligation to immediately  inform EPA under
Section  8(e)  of TSCA.   EPA's TSCA Section 8(e) policy statement
("Statement of Interpretation and Enforcement Policy;  Notification
of Substantial Risk" 43 FR 11110), which appears as Appendix C at
the back of this guide, explains clearly  that "substantial risk
information must be reported to BPA." (emphasis added)
     JtOBT SBCTIOM S f Bl IHFORMXTTOlf BE* RB

A person  is considered to have discharged  the TSCA Section 8(e)
reporting  obligation  II  the  information • is  received at  EPA
Headquarters in  writing within 15 working  days after the person
obtained  the  information.  Relevant  or significant supplemental
data obtained after an initial Section 8(e)  submission should also
be reported in writing to EPA immediately (i.e., within  15 working
days).  The reader's  attention is directed to THM DOBS CT« CTRM
"OBTAINS  IOTQBMATTQH* IJBMTT  found on  Page 6  of  this  reporting
guide.

For an "Emergency Incident of Environmental  Contamination" (EIEC),
a telephone call to the appropriate  EPA Regional  Office must be
placed immediately  (i.e.,  as soon as reasonably possible); these
phone numbers  are given  in  the next section of this  guide.    A
written follow-up report must also sent  to EPA Headquarters within
15 working days of the date on which the telephone report was made.

Specifically with regard to 1)  Section 8(e)-reportable information
obtained before January 1,  1977 and reviewed after January 1, 1977.
but prior to March 16, 1978  (the  publication date of EPA's TSCA
Section  8(e)  policy  statement),   or  2)  Section 8(e)-reportabl»

                                11
-------
 information obtained for the first time  after January 1,  1977 but
 before March 16, 1978, such information should have been submitted
 already to EPA "on or before the 60th day following March 16,  1978.

 TSCA  Section   8(e)-importable  information   (including  pre-1977
 information) that is (was) obtained by a company for the first time
 following March 16,  1978 should  be submitted  (or  should have been
 submitted already)  to EPA within  15  working  days of the date on
 which  the information is (was)  obtained by the  company for the
 first  time after March 16, 1978.
As explained  xn a technical  amendment  (52 PR 20083; May 29, 1987)
to EPA*s  Section  8(e) policy statement, Section 8(e) submissions
(including written  follow-up reports for "Emergency Incidents of
Environmental Contamination"  (EXEC)) must be transmitted to EPA at
the following address:


               Document  Processing Center (TS-790)
               (Attn: Section 8(e) Coordinator)
               Office of Toxic Substances
               U.S. Environmental Protection Agency
               401  "M" street, S.w.
              .Washington, D.c.  20460


The initial phone report for an EXEC should be placed immediately
(i.e.,  as soon as  is reasonably  possible)  to  the  EPA Regional
Office in whose jurisdiction the EXEC occurred or was discovered;
the current 24-hour phone numbers for EPA's 10 Regional Offices are
as follows.


     Region 1  (617) 223-7265     Region 6   (214) 655-2222

     Region 2  (201) 548-8730     Region 7   (913) 236-3778

     Region 3  (215) 597-9898     Region 8   (303^ 293-1788

     Region 4  (404) 347-4062     Region 9   (415) 744-2000

     Region 5  (312) 353-2318     Region 10  (206) 442-1263


In the event that a  respondent cannot reach the EPA Regional Office
in whose  jurisdiction the EXEC occurred or  was discovered, the
respondent should Immediately call the National Response Center at
(800)-424-8802 or 202-426-267S  and provide all known information

                                12
-------
requested by the officer on duty.  Under these circumstances, the
respondent will be considered to have satisfied the initial phase
of the -Section 8(e)  reporting obligation;  a written "follow-up"
report regarding the EIEC,  however, must still be submitted to EPA
Headquarters within 15 working days of the EIEC phone report.

Persons wishing to submit data to EPA's  Office of Toxic Substances
simply on a "For Your Information"  (FYI) basis and not pursuant to
Section 8(e) of TSCA should send the information to:


               Document Processing Center (TS-790)
               (Attn: FYI Coordinator)
               Office of Toxic Substances
               U.S. Environmental Protection Agency
               401 "M" Street, S.W.
               Washington,  D.C.  20460


Persons submitting information to  EPA on an FYI  basis should be
aware that  the Agency's processing  of documents  received under
mandatory reporting provisions of TSCA always takes precedence over
those submitted  simply  as  FYI.  The reader should  also be aware
that the submission of data to the Agency on an FYI basis does not
satisfy a  TSCA Section  8(e)  reporting obligation.   For further
information on this particular subject, the reader's attention is
directed to PQBB m. FQ« Tooa IKTORHXKOM  snamflSTOM BXTTBFT BBCTTOM
tfB) MQPTammiTfl? found on Page 10 of this reporting guide.
HOW MPOT BBCTIOll S f Bl IHTORMXTIOlt BB IMPORTED?

Section 8(e)  submissions  must be transmitted to  EPA in a manner
that permits the Agency to verify receipt of the submission (e.g.,
certified or  registered mail).   In addition,  the submission must
state clearly that it is being provided under Section 8(e) of TSCA.
Further, the submission must contain the name, title and telephone
number of the person sending the information, the  name and address
of the establishment with which the reporting person is affiliated,
the name(s)  (including Chemical Abstract  Service (CAS)  Registry
Number(s),  if known) of the subject chemical(s),  and  a summary
describing the nature of adverse effects or exposure being reported
together with the source of any supporting technical data.

For an "Emergency Incident of Environmental Contamination" (EIEC),
the initial telephone report must provide the time and location of
the incident  and as  much of the above information as is known at
the time.  A written  EIEC follow-up report to EPA Headquarters must
contain the same types of information that are required in a non-
EIEC initial Section 8(e) submission.


                                13
-------
In claiming any submitted information to be "Confidential Business
Information" (CBZ) under TSCA, respondents should be aware that all
of the information reported under specific TSCA requirements (e.g.,
Section 8 (e)) or in support of TSCA is subject to 1) provisions of
Section 14 of TSCA, and 2) EPA's regulations on confidentiality of
business information  (40  CFR Part 2).  Any person who submits CBZ
to EPA under Section  8(e)  should be aware that two copies nttfe be
provided.  The first  copy should be complete, with all CBZ marked
carefully and clearly by boxing,  circling or underlining; all of
the pages  containing CBZ  should be  stamped  "CaBFZDBBTXAL".   The
other copy should have all of the confidential  information excised;
this "sanitized* version  is required for EPA's public files.  Any
person who  submits CBZ to EPA  under  Section  8(e)  of TSCA should
also be  aware that the  Agency does request a  detailed written
substantiation  for all TSCA  CBZ  claims.  (A  copy of  a two-page
document entitled "Support Information for Confidentiality Claires*
is included as  Appendix E to this  reporting  guide.)   Finally, a
person who submits TSCA CBZ to  EPA under Section *(•) should also
be aware that the Agency  is under no formal.obligation to review,
and typically does  not  review, ' company-sanitized  documents' for
errors made in sanitizing those documents.
A Document Control Number is used by EPA to identify TSCA" Section
8(e) submissions  and takes the  following form:  8EHQ-0000-0000.
Starting at the left, the first four symbols identify the informa-
tion as a Section  8(e) submission received by EPA Headquarters; the
next four digits identify the month and year (e.g., -0591-) of the
Agency's receipt of the  information; the final  four digits identify
the submission's  chronological number.  Zn addition to the basic
numerical sequence, additional characters may be added to the right
end of  the Document Control Number to convey other information.
These additional characters, and their  meaning are as follows:


     S:   indicates that the Section 8 (e) notice was "sanitized to
          delete  information claimed  by the submitter ~to be TSCA
          Confidential  Business Information (TSCA CBZ);


     P:   indicates that the Section 8(e) notice contained a name
          or other identification (e.g., a Social Security Number)
          of an individual, the release of which may violate the
          Privacy  Act;  such  documents are sanitized by  EPA to
          remove such identifiers;
                                14
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     *:   indicates that based on EPA's preliminary evaluation, the
          submission was either considered to be unwarranted for
          •reporting under Section 8(e) of TSCA or that it was not
          clear to EPA  that  submission was warranted and further
          clarifying information was requested from the submitter.


  INIT:   denotes that the submission is an initial submission;


  FLHP:   indicates that the  submission is a followup response; and


  SUPP:   indicates that the notice is a supplemental submission.


By definition, follow-up response submissions contain information
submitted directly in response to a specific EPA request, whereas
Bupplenental  submissions are those that  contain information not
specifically requested by the Agency.



BOB* DOBS ora uvrn/usB aamoB a r BI moiuamom
Although EPA's receipt of  information  under Section 8(e) of TSCA
does not necessarily trigger immediate regulatory .action under TSCA
or another authority administered by EPA, the submitted information
is processed  and evaluated on  a  priority basis  to determine an
appropriate level of concern and initial course of Agency  action.

Thus far, EPA and the chemical  industry have devoted significant
efforts  in fulfilling  their  respective  responsibilities  under
Section 8(e) of  TSCA.  Since January  1,  1977,  over 1250 initial
Section  8(e)  notices covering  a broad range  of  toxicity  and
exposure-related  data on a wide  variety of  chemicals have been
received by OTS  and been given  priority evaluation and  follow-up
attention.

In general, each initial TSCA Section 8(e) submission is promptly
reviewed and evaluated by  OTS scientific staff to determine both
the degree  of concern that  should be attached  to the  submitted
information and the initial course of any warranted OTS  follow-up
action(s).  A "status  report"  is prepared containing  a  brief
description of the submitted information,  the results of the OTS
preliminary evaluation, a statement regarding production and  use of
the subject chemical (s) and recommendations for appropriate follow-
                                15
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up  actions.2  Upon  approval of  the status  report,  recommended
follow-up  actions  are initiated.   A letter forwarding the status
report and any EPA requests  for additional information is sent to
the  subaitting  organization.  In addition, copies  of all status
reports are transmitted to EPA's public files,  other designated EPA
Program Offices and Federal Agencies, and to the OTS Environmental
Assistance Division  (EAO/OTS) for further distribution.

Other OTS  follow-up actions  include  the consideration of further,
more in-depth assessment of the reported chemical's hazard or risk.
OTS  staff  also immediately reviews,  evaluates,  and  initiates
appropriate  follow-up actions or activities on information that is
contained  in "follow-up" and  "supplemental* TSCA Section  8(e)
submissions; over 2000 TSCA Section 8(e) supplemental and follow-up
submissions have been received and promptly evaluated by OTS staff
since January 1, 1977.

OTS  utilizes TSCA Section 8(e)  submission data  for hazard/risk
identification purposes primarily in the initial stages of the OTS
Existing  Chemical  Program (ECP).   OTS also  uses  these  data  in
ongoing health and exposure  assessments of both existing and new
chemicals  and in  support off- regulation development  under TSCA,
e.g., development of chemical testing rules under  TSCA Section 4.

EPA's proactive implementation of Section 8(e)  of TSCA has resulted
in heightened overall awareness of the risks posed  by exposure to
chemical substances  and mixtures.'   Many behe'f its and-impacts are
evident from EPA's dissemination of  TSCA Section-  8(e) and-related
information  to7'other  EPA Offices,  other' Federal - agencies,  the
general public and the international communityv;  This heightened
awareness  has led, in many cases, to specific activities designed
to directly or indirectly protect health2 and/or the  environment.

OTS  ha*  established-high  level  scientific   and  administrative
contacts  in  each  of the major EPA ~ Program Offices and Regional
Offices to provide  a mechanism  for the timely  and prioritized
dissemination  of  information  about  newly   discovered  chemical
hazards or risks.   These  other EPA  Program and Regional Offices
effectively and routinely utilize TSCA Section 8(e)  information in
     *   As of October"!, 1990,' OTS begaif to issue "summaries"'
rather than "status reports"^ for" incoming initial Section 8(e)
submissions.  These summaries contain a detailed accounting of
toxicologic and other information  (e.g., voluntary pollution
prevention/risk reduction information, exposure data) presented
in the initial TSCA Section 8(e) submission.  The summaries do
not reflect, however, the Agency's evaluation or disposition of
the reported information.  Copies of Section 8(e) submission
summaries can be obtained in the same manner used to obtain
copies of Section 8(e) status reports.


                                16
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implementing their  regulatory  programs.   The  following  examples
illustrate just soae of the actions/activities initiated by other
EPA Offices in response to Section 8(e)  and related data.
     office of Water
          preparing/revising Water Quality Criteria Documents and
          Drinking Water Standards.
          A of flolid •*&•£•
          determining  the  need  for/revision  of   listing   and
          delisting actions under  the Resource Conservation  and
          Recovery Act (RCRA);  and

          establishing/revising "Reportable Quantities" (RQs)  and
          "Threshold Planning Quantities"  (TPQs) for the chemicals
          that are  under the  jurisdiction of the  Comprehensive
          Environmental Response,  Compensation,  and Liability Act
          (CZRCIA; "Superfund").
     Office of Research ajfl Development fORD/BPAl

          preparing/revising  Health  and  Environmental  Effects
          Profiles (HEEP«), Health Effects Assessments (HEAs)  and
          Acceptable Daily  Intakes (ADZs)  for  us* by  other EPA
          Program Offices;  and

     *     determining the need for new EPA  research or  impact on
          ongoing. EPA research activities.
     Office of Air iflfl Radiation IOAR/8PAI
                                     i
     •     determining the need for and revising rules which govern
          chemical substances released to the air from stationary
          and/or mobile sources.
     Office of Pesticide Pr            OPTfl/BPX
          assessing or reassessing the toxicity of or exposure to
          active ingredients/ inerts in pesticides under the Federal
          Insecticide, Fungicide and Rodenticide Act (FIFRA) .

                               17
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     	ttecyional Offices

          EPA*s 10 Regional Offices routinely receive copies of all
          updated indices for OTS holdings of Section 8(e) and FYI
          notices. Zn addition to providing new information about
          reported chemical hazards/risks, Regional receipt of this
          information has led numerous cases to compliance inspec-
          tions under TSCA and other EPA administered authorities.


EPA has also established high level scientific and administrative
contacts in other Federal agencies in  order to provide a mechanism
for the timely and prioritized dissemination of new information on
chemical hazards/risks.  The following examples illustrate some of
the activities that have been initiated by other Federal agencies
in direct  response to TSCA Section 8(e)  and  related information
supplied to those agencies by EPA.
          n»i Institute for Occupational BafatT and Health (

          preparing/revising currant intelligence Bulletins*

          determining the need for workplace investigations leading
          to published Health Hazard Evaluations;

          recommending to OSHA the need for new workplace standards
          or revisions to existing workplace standards;
          dati
lining the need for new research or the impact  on
          ongoing chemical research activities'; and
          input  of data  into the Registry  g£ Toxics  Effects of
          Chemical  Substances  (RTECS)   publication and  on-line
          computerized data base.
          internally reviewing and distributing information to OSHA
          Regional/Area Offices and inspectors;

          filling data gaps in ongoing OSHA assessments/studies or
          determining the need for such assessments/studies; and

          determining the need for new OSHA workplace standards or
          revising existing workplace standards.
                                18
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                      Bafatv «j<^mf aaion (CPSC1
          -determining the need for new CPSC regulatory efforts or
          the revision of existing CPSC regulations; and

          internal and external information circulation as part of
          CPSC's "Current Awareness Activities."
     Mational Library gf Madieina (BUI)
          input of toxicologic/exposure  information to the HI/!1!
          publicly accessible computerized data bases.
     Mational Toxicology frg^fM (SEX)

          evaluating chemicals for toxicologic testing;

     •    monitoring results of non-NTP toxicity studies; and

     •    supplementing results of ongoing NTP studies.



     InteraqeBcr Testing gtmittM (IXfi)

     *    determining need for recommending chemicals for TSCA
          Section 4 health/environmental effects testing.



DO flflkTUfl BSPOR¥fl UnSBKra 89X*fl "BOTTOM X.T1RM BSSXllDTlfa BISK?
When reviewing TSCA Section 8(e)  status reports, the reader should
realize that the purpose  of the  OTS preliminary evaluation is to
determine the significance of the submitted information in terms of
a need for possible follow-up  action by EPA.  This determination
involves a critical analysis of  the submitted data to assess the
extent that the reported hazard/risk is supported by the  provided
information.  The  scope of this initial  evaluation,  however, is
generally limited  to the submitted documents  and to any closely
related information known by and/or readily available to the OTS
staff reviewer.   Neither  a literature search to identify other
reported effects nor an in-depth analysis of possible sources of
exposure to  subject chemicals  is part of the initial evaluation
process.  Therefore,  a status  report  should be viewed only as a
preliminary evaluation  of the  submitted information and  not as a
comprehensive assessment of the chemical  substance or mixture for
which a TSCA Section 8(e) notice has been filed.

                                19
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The  1978 Section 8(e) policy  statement,  as frequently cited and
quoted in 1) publicly available  EPA "Question and Answer"  (Q&A)
documents on TSCA implementation  issues raised at periodic public
and  individual  meetings with Agency staff and management, and 2)
numerous publicly available  Section 8(e)  "status  reports" that
provide  illustrative examples   of  Section   8(e)-applicability,
continues to serve as  a sound and  adequate  basis for potential
respondents  to determine their  mandatory  reporting obligations
under  Section 8(e) of  TSCA.   In addition,  EPA's publication of
bound  volumes of  Section 8(e) status reports serves a two-fold
purpose.   First,  volumes of status  reports with indices help to
make the  information reported under  Section 8(e)  more readily
accessible.   Second,  these  Section 8(e) status report volumes, by
providing easy access to specific  examples of submitted information
and  EPA's preliminary evaluation  of  the information, help subject
persons to understand better the  kinds of information that should
be reported  to  EPA under Section  8(e) of TSCA.  The six  • >) bound
Section 8(e)  status report volumes published by the Agency to date
can  be purchased  directly from the National Technical Information
Service (MTZS).  The MTZS  publication numbers of,  and the TSCA
Section 8(e)  submission numbers covered by, these volumes are as
follows:
     MTTS Publication MUnhM?
     Subni.sfli.an Munbai
          PB| 80-221609

          FBI 81-145732

          PB| 83-187815

          FBI 87-129409

          FBI 87-176004

          FBI 89-182687
8EHQ-0777-0001

8EHQ-0779-0292

8EHQ-0280-033X

8EHQ-0183-04C8

8EBQ-0185-0542

8EHQ-0187-OC49
to 8EHQ-0679-0291

to 8EHQ-0180-0330

to 8EHQ-1282-Q4C7

to 8EBQ-1284-0541

to 8EHQ-1286-OC48

to 8EHQ-1288-0778
Zt should be noted that..a. seventh Section 8(e) status report volume
covering initial Section 8(e) submission numbers 8EHQ-0189-0779 to
8ERQ-0989-10S4 should be published by EPA in the summer of  1991;
notice of  the availability  of  this new status report compendium
will be  given in the OTS  "Chemicals-in-Progress Bulletin."  EPA
plans to print only a limited number of copies of the new status
report volume for distribution by  the  TSCA Hotline.  After that
supply is exhausted, copies of the new compendium can be purchased
from MTZS.  The addresses and telephone numbers for MTZS as well as
the TSCA Hotline can be  found in the "Prefaoe"  to this guide.
                                20
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With the exception of certain TSCA Section 8(e) Q&As that were made
available by EPA in July  1989, all of the Agency's other published
Section-8fe)-related Q&As (1986 and 1987) are embodied in full or
in part in other sections of this reporting guide.  For the sake of
completeness, the specific Q&As from that  July  1989  Section 8(e)
Q&A document follow.


     Q.   Does Section 8 (e) of TSCA intend the submission of animal
     test information:  (a)  when a determination  of  "substantial
     risk" has been made, or (b)  where merely a finding of positive
     animal  test results  useful  in the further assessment of human
     risk has been determined?

          ft.   TSCA Section 8(e) requires the timely submission of
          evidence (including preliminary evidence)  from  animal
          studies that implicates the tested chemical  as causing
          serious toxicologic effects (e.g., cancer, neurotoxicity,
          birth defects).  A decision to report the observance of
          such serious toxicological effects should  not  hinge in
          any way on a judgement of either the actual or potential
          exposure to  the chemical or a judgement about the degree
          of relevancy of the findings to an overall assessment of
          human risk.  In other words, the decision to report under
          Section 8(e) in such cases should be based simply on the
          observance of  the serious toxicologic effects.


     Q.   What criteria should be used to determine if the results
     from cancer bioassay studies in animals should be submitted to
     the Agency under Section 8(e)  of  TSCA?    For example,  when
     should  animal studies  showing only a significant increase in
     benign  tumors over  controls be submitted?

          A.   Reporting of benign and/or malignant tumors should
          take place, for  example,  when either statistically or
          biologically significant  increases  over controls  are
          observed.  The  observation of such  increases are made in
          many cases  at interim  sacrifices performed  typically
          during long term  exposure studies in animals.


     Q.   How should reproductive or developmental toxicity data be
     evaluated for possible  Section 8(e)  submission  if  maternal
     toxicity is also present?

          a.   Statistically or  biologically significant increases
          in teratogenic effects or other  serious embryotoxic or
          fetotoxic effects  (e.g.,  significant embryo  or  fetal
          lethality, spontaneous abortion) should be reported under
          Section 8(e) regardless of the level of maternal toxieity
          observed in the study.

                                21
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Q.   What  are the criteria that should be used to determine
which  reproductive/developmental effects observed in animal
tests  are  reportable under Section 8(e)7  For example, should
reversible developmental effects, such as reduced birth weight
and/or incomplete  ossification,  trigger TSCA  Section 8(e)
reporting?

     A.    Zn addition to teratogenic effects, serious adverse
     developmental  effects (e.g., significant embryo or  fetal
     lethality,  significantly  reduced  fetal/birth  weights,
     significantly  retarded/incomplete skeletal ossification)
     should be reported.  Zn addition, serious adverse effects
     on the male/female reproductive system (e..g., significant
     testicular or ovarian atrophy, significantly reduced fer-
     tility,  sterility) should be reported under Section  8(e).


v>   What  criteria should be used in determining if results of
acute toxicity studies constitute information that reasonably
supports a conclusion of  substantial risk?

     A.    Criteria used to determine Section 8 (e) reporting in
     the case of acute/subacute toxicity findings will depend
     on the  nature of the effects observed  and the dose at
     which .the effects occurred.   For example, information
     that  shows a tested chemical to be extremely toxic (e.g.,
     causes  lethality at very low doses) by,  for  example,
     inhalation Jr dermal application or oral" administration
     should be reported.  On the other hand,  the reporting of
     information  showing  a chemical to be moderately  toxic
     will  depend on the degree of actual or potential exposure
     to the tested  chemical.   Znformation showing a  chemical
     to be slightly or minimally toxic on an acute/subacute
     basis is not considered  typically  to be reportable:' Zn
     addition to  extreme toxicity,  certain other serious
     toxicologic effects (e.g., neurotoxicity, adverse repro-
     ductive  system effects)  seen  in  an  acute  or  subacute
     animal study should be reported under Section  8(e).


Q.   When  evaluating.subchronic animal studies, what criteria
should be used to determine reportability of  adverse effects?
For example,  should* increased or decreased organ(s) size in
the absence  of histopathological changes be reported to  EPA
under Section 8(e)  of TSCA?

     1>.    Serious  toxic effects  (e.g., neurotoxic  effects,
     serious  reproductive system effects) observed during the
     conduct  of subchronic studies should be reported.  This
     includes readily  observable serious effects or serious
     effects  seen only as the result of gross and/or histo-
     pathological examination.   As is the case for  acute  and

                           22
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          aubacuta toxicity  studies,  the degree  of the observed
          toxicity is important.  The acre serious  (or significant)
          the observed effect, the less heavily one should consider
          actual/potential exposure for Section 8(e) reporting and
          vice versa.


     Q.   What criteria  constitute  evidence of reportable neuro-
     toxicity  in animal  studies?    For example, are reversible
     effects such as narcosis or effects observed in the presence
     of marked systemic toxicity considered reportable?

          A.   Typically, neurotoxic effects seen  in dying animals
          are not, in  and of themselves,  considered by EPA to be
          reportable under Section 8(e).  In many cases, however,
          already reportable data  regarding extremely or highly
          toxic  (lethal) substances will be accompanied by infor-
          mation concerning observed neurotoxic effects.  Zn short
          or long term exposure studies in which serious neurotoxic
          signs and symptoms (e.g., convulsions, sleep induction,
          motor dysfunction,  narcosis,  behavioral dysfunction) are
          seen in non-moribund animals, however, specific reporting
          of the neurotoxic effects should occur.


     Q.   What criteria  should be  applied in determining whether
     positive results  of Jj|  yjjgg or In vitro mutagenicity assays
     trigger Section 8(e) reporting?

          A.   serious la vivo genotoxicological effects (e.g.,
          gene or chromosomal mutations) are reportable in and of
          themselves under Section 8(e).   On the  other  hand,  a
          positive In vitro genotoxicity test,  when considered
          alone, is usually insufficient-to cause reporting under
          Section 8 (e). However, EPA believe* that such information
          is of value  in assessing the possible risk(s) posed by
          exposure to the tested chemical or mixture.  Further, the
          Agency  believes that a positive 'In vit^o genotoxicity
          test result,  in combination with other information (e.g.,
          knowledge of actual/potential exposure to and/or high
          production of  the tested chemical), would suggest the
          need, in many cases,  to conduct further studies designed
          to determine the toxicity of or the exposure  to that
          chemical.   EPA expects the  results  of such additional
          studies to be considered also for 8(e) submission.


Any person wishing to obtain full copies of the 1986 and 1987 Q&A
documents (which also contain numerous Q&As related to rules that
have been promulgated by EPA under other sections of TSCA) should
contact the TSCA Hotline at  the  address or the telephone/telefax
numbers listed in the "Preface" to this reporting guide.

                               23
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HOW CAIt THE  WBLTG OBTXTg flgCTIQM. 8 f ^] -.-„ 	

Non-confidential  versions of TSCA Section 8(e) initial, follovup
response and supplemental submissions, status reports, submission
summaries, and EPA followup letters can be viewed/copied in the OTS
Public Docket.  Copies of non-confidential Section 8(e) documents
can also  be obtained by  writing  to  EPA's Freedom of Information
Office.  The addresses of the OTS Public Docket and the Freedom of
Information Office are given in the "Preface" to this guide.

Information  on each new  initial' Section 8(e)  and FYI submission
(i.e., submission number,  name  of the  subject chemical(s), and
nature of the information received) is presented in index form in
the OTS "Chemicals-In-Progress Bulletin" published periodically by
the Environmental Assistance Division  (EAD/OTS) and  sent  by the
TSCA Assistance Information Service (TSCA Hotline)  to over 9,000
individuals in industry, environmental groups,  labor, academia and
Federal, State, and Local Governments.  Persons who wish to receive
the "Bulletin" should contact the TSCA Hotline via the addresses or
phone/telefax numbers in  the "Preface" to this guide.
As explained in more detail  in HM m* laanra am* MCTTOM af«i-
MLxmm OTIBMICT?  on  Page 20 of this reporting guide, volumes of
TSCA Section 8(e)  status reports have been published by OTS on a
biannual basis; six volumes have been published to date and contain
status reports covering the first 778 initial.TSCA Section 8(e)
submissions), and a seventh volume is scheduled.to be-published by
OTS during the summer of.,,. 1991.   Persons interested in obtaining
copies.of thes* TSCA7 Section 8(e)  status/ report-^ vglumes should
contact the TSCA  Hotline,-, or .the National. Technical Information
Service  (NTIS) at  the  addresses and phone., numbers  given in the
•Preface"  to this  reporting  guide.

Data from TSCA Section 8(e)  and FYI submissions are entered into
T8CAT* (Toxic Substances Control Act Test Submissions), a publicly
available computerized data base that serves as an on-line index of
unpublished health and safety studies submittedLto EPA-under or in
conjunction with TSCA.  The submitted studies themselves are stored
on microfiche.   Persons who wish to obtain access to the on-line
TSCATS should contact either the National Library of Medicine (NLM)
located in Rockville,  Maryland,  or Chemical Information Systems,
Inc. (CIS) located in Baltimore, Maryland.  Microfiche copies of
the submitted  studies cited  in TSCATS can be obtained from either
CIS or the National Technical Information Service (NTIS) located in
Springfield, Virginia...  The addresses/telephone numbers for NLM,
CIS and  NTIS  are  presented in  the "Preface" to this reporting
guide.

In order  to assure that the public sector is kept apprised about
new adverse health effects and exposure information, OTS actively
disseminates TSCA  Section 8(e)  and FYI submission information tc
many individuals and organizations in the following ways.

                                24
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          all non-confidential TSCA Section 8(e) and FYX notices,
          status  reports,  summaries  and  follow-up letters  are
          'placed in public files located at EPA Headquarters.

          volumes of Seetios 8(0) status reports are published by
          OTS on a biannual basis; six volumes have been published
          to date and contain status reports covering the first 778
          initial TSCA Section 8 (e) submissions); a seventh volume
          is scheduled  to  be published by the  Agency  during the
          summer of 1991.

          in response  to  numerous  "Freedom of  information Aot"
          (FOXA) requests that are received by OTS and that mention
          a chemical that is  the subject of a TSCA Section 8(e) or
          FYX submission, OTS staff provides appropriate citations
          for, and in some  cases full  copies of, all such relevant
          documents;
     •    aaerioaa Ceaferases of acverasa&t&l Zsdsstri&l
          (ACGXH) publishes on occasion complete copies of selected
          Section  8(e)  "Status Reports" in  the ACGXH scientific
          journal. Applied Industrial Hvaiene.


The international community is  routinely notified by EPA about the
availability of TSCA Section 8(e) and FYX submissions via the OTS
•Chemicals-Xn-Progress Bulletin."   Approximately 1000 persons in
international  organizations,  foreign  governments, agencies and
companies are on the mailing list.   The  "Bulletin"  is also used to
routinely solicit unpublished chemical toxicity/exposure data from
the international  community.   Under the established  "Freedom of
Information Act" (FOXA) procedures as veil as the Organization for
Economic Cooperation and Development (OECO)  information-gathering
•Switchboard"  project, OTS responds  to' numerous international
requests for unpublished  health and safety  data on chemicals of
concern to OECO
On May IS,  1987, EPA's Office of Compliance Monitoring (OCX) issued
a final "Enforcement Response Policy" (ERP) covering Section 8(e)
as well as the record-keeping and reporting  rules issued by EPA
under Sections 8, 12 and 13  of TSCA.   This ERP describes various
enforcement  alternatives  (including  notices  of non-compliance,
civil penalties, criminal action and injunctive relief) available
to the Agency in  enforcing these  TSCA record-keeping/reporting
provisions.  Copies of the TSCA Sections 8, 12 and 13 ERP can be
obtained from OCX or the TSCA Hotline; the  addresses and/or phone
numbers for  these  EPA offices are presented  in the "PRBflCB" to
this reporting guide.

                                25
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On Friday, February 1, 1991, EPA announced in the Federal Register
(56 FR 4 12 8T," "a one-time voluntary TSCA Section 8(e) "Compliance
Audit  Program"  (CAP).  The  Section  8(e)  CAP,  which incorporates
stipulated  monetary  penalties  and  an  overall monetary  penalty
ceiling, is designed  primarily to 1) achieve the Agency *s goal of
obtaining any outstanding Section 8(e) information, and 2) provide
ni«vi«Hn» encouragement to companies to voluntarily audit their files
for Section 8(e)-reportable  information.

Modifications made to the Section 8 (e) CAP were announced by EPA in
the Federal Register on Friday,  April 26,  1991  (56 FR 19514) .  The
major modifications were 1)  an  extension of the CAP registration
and termination dates,  2)  addition of an opportunity to petition
EPA for a case-by-case  extension of the CAP termination date, 3)
modification of the CAP  "Agreement" provision involving admission
cf a Section 8(e) violation,  and 4) an announcement of the Agency's
plans to prepare and  disseminate this TSCA Section 8(e) reporting
Additional modifications to the Section 8(e) CAP were announced in
the Federal Reaiater on Thursday,  June 20,  1991 (56 FR Part XV) .
The additional modifications announced by EPA were 1) an extension
of the Section 8(e)  CAP registration deadline, 2) announcement of
the availability of this Section 8(e)  reporting guide, 3) addition
to the CAP of a "listing" provision and reduced stipulated penalty
for certain  types of Section  8(e)-reportable  information now in
EPA's possession as the result  of either i) formal submission under
a mandatory reporting_.provision of TSCA or other EPA-administered
statute^ or ii)  tfuBmirtion to EPA and filing within EPA's Office of
Toxic Substances  formal "For  Your Information" (FYI)  submission
filing system, and 4) suspension of Parts V(b) (l) and V(c) of EPA's
TSCA Section  8(e) policy  statement for purposes of  judging the
reporcability of information concerning "widespread  and previously
unsuspected distribution JjT 'environmental  media"  and "emergency
incidents of environmental contamination" under the Section 8(e)
CAP.

With regard to Parts V(b) (1) and V(c) of the Section 8(e) policy
statement, the June 20, 1991  Federal Register announcement also
informed the regulated 'community that until suctt^time as the Agency
determines with;  greater:; specificity what ~ type* of ' environmental
release', environmental  detection and environmental contamination
information should be submitted under  Section • (•) of  TSCA, the
statutory language of Section 8(e)  was to be utilized to determine
reportability of such information for purposes of the Section 8(e)
CAP as well am ongoing  compliance with  Section 8(e).

For the  reader1*  ease,  complete copies of EPA's Federal Register
announcements of the Section 8 (e) CAP and the CAP modifications are
presented in chronological order in Appendix D at the back of this
reporting guide.


                                26
-------
                       gfiQM a'igi ngQUcaaOT ACTIONS?
Since  1977, EPA  has . initiated  a  number of  formal enforcement
actions  relating  to Section 8(e) of TSCA.   in almost all cases,
EPA's actions have  dealt with the late reporting of animal study
findings that offer reasonable support for the  conclusion that the
tested chemical substance (s) presents a substantial  risk  of injury
to health.  Persons interested in reviewing the filings pertaining
to specific Section 8 (e) enforcement-related actions should contact
either the Office of compliance Monitoring (OOf) or the  Office of
Enforcement  (OE) at the addresses in the  "Preface"  to this guide.
         i a g|gi
EPA's longstanding proactive implementation of Section 8(e)  of TSCA
h*« r««uJLt«d in heightened overall chemical industry awareness of
risks posed by exposure to chemical substances and mixtures.  This
heightened awareness has led, in many cases, to specific voluntary
pollution prevention/risk reduction activities designed to directly
or indirectly protect health and the environment.  It can be argued
that EPA's Section 8(e) implementation encourages these voluntary
actions  to  occur earlier than  they  might occur otherwise.   The
following discussion describes some of these voluntary actions.

The  chemical  industry's  increased  awareness  of  the potential
hazards/risks posed by chemical substances is evidenced in  part by
the voluntary reporting of over 800 initial "For Your Information"
(PYZ) submissions containing valuable toxicity and  exposure data.
Zn direct response to OTS followup efforts, many chemical companies
have  established  review  committees  responsible  for evaluating
chemical toxicity and exposure information to consider the  need to
report to EPA  (e.g.,  under Section 8(e)  of TSCA)  or to initiate
actions designed to minimize or eliminate chemical exposure.  Many
companies have also established  information, distribution networks
to facilitate the flow of  health/safety data to workers, customers
and other producers.  Many companies have reported  that in direct
response to new chemical toxicity or exposure data  reported under
Section  8(e) or on an  FYX  basis,  the following  types of health
and/or environmental protection  measures  have been  initiated on a
voluntary basis:


     Notification

     •    formal notification of workers, customers, others

          changes  made  to product labels and/or Material safety
          Data Sheets (MSDSs) to ensure proper and  safe handling


                                27
-------
Purther_-S£lldv
     additional studies performed in order to detanine battar
     tha toxicity of and/or the exposure to  cheaicals
Pollution Pravantion/gxpQatira Raduetion
     anginaaring changas aada in aanuf aeturing and procasaing
     facilitiaa to raduca/aliminata chaaical  axposura

     chaaical aanufactura or uaa haltad taaporarily or
     discontinued altogathar.
                         * * * *
                           28
-------
OIITBAlfGB
                                         kl.
•An acute oral  (gavage)  LD50  study was conducted on a commercial
chemical.  Following administration of the test material, rats were
observed for 14 days for clinical signs of toxicity.  At the end of
this observation  period, all surviving rats  were sacrificed and
examined for gross pathological changes.  Rats found dead were also
subjected to  gross pathological examination.  The oral  LD50 was
calculated to be 40 mg/kg.  Nonspecific clinical signs were initi-
ally observed in all treated rats;  all  signs had receded by Day 14
in those animals which survived.  Gross pathology revealed nothing
unexpected."

The case study did not contain any other relevant  information for
EPA to consider in judging the Section 8(e)-reportability of this
acute oral toxicity study of a commercial chemical  substance.  Also
at issue for  this particular  case  study  is the perceived need to
have 1) numerical guidance  for  reporting lethality seen in acute
and other types of animal toxicity studies, and 2) reaffirmation of
EPA's policy  on whether and how exposure should be considered by
companies in evaluating acute lethality data for reporting.
     EPA Discussion

The Agency  believes that the  following general "rules-of-thuab"
should be used in determining the  Section 8(e)-reportability of
significant  lethality observed  in any animal  study  (including
acute, sub-acute  and other types  of studies  such as  teratology
studies)  of  a TSCA-covered chemical substance (including a research
and development [R&D] chemical):


  o  Significant  lethality  which is  observed at  a dose or
     concentration comparable to an acute oral L050 value of
     £5 mg/kg, an acute dermal LD50  value of <20 mg/kg,  or an
     acute (generally 4-hour)  inhalation LC50 value of £50 ppm
     (or £0.5 mg/1)  should be  recognized immediately as  being
                                29
-------
     indicative of "extreme" toxicity and should be considered
     for immediate reporting to EPA under Section 8 (e) of TSCA
     without any consideration of actual or potential exposure
     or other factors.


  o  Significant lethality observed at a dose or concentration
     comparable to an acute oral LD50 value in the range of >5
     mg/kg  to £50 mg/kg, an acute dermal LD50 value in the
     range of >20 mg/kg to £200 mg/kg, or an acute (generally
     4-hour) inhalation LC50 value in the range of >50 ppm (or
     >.0.5 mg/1) to £200 ppm (or-£2 mg/1) should be recognized
     as indicating  "high" toxicity  and should be .considered
     for immediate  reporting under  Section  8(e)  if there is
     actual or reasonably anticipated exposure to the subject
     chemical substance.


  o  Significant  lethality observed at doses  greater  than
     those cited previously (i.e., doses indicating "moderate"
     toxicity) should be considered for reporting to EPA under
     Section 8(e) based on the company's review of additional
     information . (including^but not limited  to information
     about actual or potential  exposure to the  tested chemical
     substance or mixture).


Specifically regarding findings of "high" toxicity, EPA expects a
company to be especially prudent and to err on the side of caution
for reporting (i.e., there is a clear bias toward reporting).  EPA
also believes that the greater the toxicity,  the less heavily one
should weigh-the actual or potential exposure  to  (or other factors
involving) the tested chemical. Further, if the tested chemical is
a "commercial,", substance: (e.g., not one that  is exclusively R*D),
there must be a strong presumption of actual or potential exposure
for reporting toxicity data in this range.  On the other hand, many
exclusively R&O chemical  substances with toxicities in the "high"
range, would not typically be reported under Section 8(e) of TSCA.
Zt should  be noted  also that any consideration of  exposure and
additional information in cases involving the "high" toxicity range
should be accomplished jwtpeditiously and should not be exhaustive
nor equated in any way with the need to conduct a full scale risk
assessment for the tested chemical(s).

The preface to Part V of  the Agency's March 16,  1978 Section 8(e)
policy statement provides further guidance regarding the types of
additional  factors to  consider in determining the need to report
information under Section 8(e) of TSCA.  For  the reader's ease in
use, the  specific  lethality values/ranges discussed  herein are
presented in Table i at the top of the next page.
                                30
-------
   Table-'!"  Factors to Consider in Determining Reportability
             of Lethality Information Under TSCA Section 8(e)
LDSO
oral
Dose
£5 ag/kg
>5 ag/kg
to
£50 ag/kg
>50 ag/kg
LDSO
Dermal
Dose
£20 ag/kg
>20 ag/kg
to
£200 ag/kg
>200 ag/kg
4-Hour LC50
Inhalation
Dose
£50 ppa (£.5 ag/1)
>50 ppa (>.5 ag/1)
to to
£200 ppa (£2 ag/1)
>200 ppa (>2 ag/1)
Consider
Exposure/Other
Factors?
No
fEXTREMEI.Y TOXIC!
Only to Some
Reasonable Degree
(HIGHLY TOXIC)

Yes
(MODERATELY TOXIC)
     EPA Coneluaion

Based on the preceding  discussion  and EPA's review of this acute
animal lethality study, the oral LDSO value of 40 ag/kg indicates
that the tested cheaical substance is "highly" toxic (i.e., an oral
LDSO of less than 50 ag/kg but greater than  5 ag/kg).  Considering
that the tested cheaical is "commercial," and in the absence of any
relevant exposure-related  information to  the contrary,  EPA makes
the prudent assumption that there is or there reasonably could be
exposure to  the tested cheaical.   Therefore,  EPA believes that
these acute lethality findings  shoving the  chemical to be highly
toxic should be reported immediately under Section 8(e) of TSCA.
     Case Study

•An oral  LDSO study is  conducted in which  animals [ (rats) ] are
administered 50, 200, 500, 1000,  or 2000 ag/kg of a  test material.
Shortly after dosing, intermittent lethargy, ataxia and convulsions
                                31
-------
are observed in the 1000 and 2000 mg/kg groups. Salivation, ataxia
and  lethargy- -are  observed in animals  in  the 200 and  500 mg/kg
groups.  No effects are observed in the 50 mg/kg dose group.  All
rats  died  at the 2000  mg/kg  dose  level.   The lower dose animals
survived to necropsy."

The case study did not  contain any other relevant information for
EPA to  consider in judging the Section 8 (e)-reportability of the
findings from this acute oral toxicity study.  Also at issue for
this  study is the  need for EPA to verify that  statistically or
biologically significant "frank" neurotoxicologic effects seen in
acute or other animal studies should be reported immediately.
     BPA Diaeuaaion

In reviewing these results of this acute oral toxicity study, EPA
made the following assumptions about the study conduct/findings:

     1.   the study had a 14-day post-dosing observation period;

     2.   no animals in the 50,  200,  500 or 1000 mg/kg dose groups
          were found moribund during the 14-day observation period;

     3.   "shortly" means a time period of  less than a day;

     4.   "intermittent" means on a number of occasions throughout
          the observation period;

     5.   the terms "convulsions" and "ataxia* accurately reflect
          the observations made during the  study; and

     6.   a signiffcant fbiologicall^ or statistically) number of
          rats in the study were affected.

Given the above  assumptions,  EPA believes that the findings from
this acute  oral  toxicity study  can  be meaningfully interpreted.
Shortly after dosing and at some unknown time prior to death, the
animals in the 2000 ,mg/kg.group exhibited  intermittent lethargy,
ataxia and* convulsions; rair of the animals  in the 2000 mg/kg dose
group died at some unknown point after dosing.  Although interpre-
tation of the findings for the 2000 mg/kg  dose group animals would
depend upon whether the adverse effects were observed in moribund
or non-moribund  animals,  by considering the information provided
for the lower dose; groups, it is  possible to determine that the
tested chemical substance caused distinct neurotoxicologic effects.
Based on EPA's assumption that  no animals in the 1000 mg/kg dose
were found  moribund during the  study,  the observations  that a
significant number of animals at this dose  exhibited intermittent
lethargy, convulsions  and ataxia, show that  the tested chemical
caused serious neurotoxicologic effects.  Furthermore, although the

                                32
-------
animals  in the  200  and  500  mg/kg dose  groups did  not exhibit
convulsions,  the animals  in both  of these  groups  exhibited a
combination of  signs  indicating a neurotoxicologic effect (i.e.,
salivation, lethargy and ataxia.)  Considering that the oral LD50
of the test material is somewhere between  1000 and 2000 mg/kg, the
finding of distinct neurotoxic  effects at doses that are perhaps
between 10% and 25% of the lethal dose further heightens concern
for the tested chemical substance.

In general, the Agency would agree that it may not be possible to
distinguish or  attribute  neurobehavioral  effects or neurological
signs  in  moribund animals to a direct neurotoxic  action of the
tested chemical substance. However, statistically or biologically
significant neurotoxic effects  observed  in  non-moribund animals
(including animals in  groups  receiving doses equal to or greater
than lethal doses) in any type of study «*^Bfl^ be dismissed simply
as reflecting a "system  overload"  and should  be  considered for
immediate  reporting  to the  Agency under Section 8(e)  of TSCA.
Further, EPA believes that good product stewardship dictates that
studies designed to  more specifically assess  neurotoxic effects
should be  considered  for any chemical found  to produce possible
neurotoxic effects during an acute or  other general toxicity test.
     EPA Conclusion

Based on the preceding  discussion and EPA's review of this acute
oral toxicity case  study,  the distinguishable neurotoxicological
effects caused  by the subject chemical  should  be reported under
Section 8(e).   The  reportability of the findings would simply be
enhanced if the tested chemical was already on the market.

To provide a sense of scale for the Section 8(e)-reportability of
neurotoxic/neurobehavioral findings from acute and other types of
animal toxicity studies  (e.g., 28-day studies, teratology studies),
the Agency  is  most interested in receiving reports that involve
•serious or prolonged effects."   Zn  general,  the acute toxicity
LD50 values/ranges  listed  in Table  i (found on  Page  31 of this
reporting guide) should  be consulted first and an appropriate level
of consideration should be given  to exposure and/or other factors
in determining reportability based solely on lethality  in acute or
other types of animal toxicity studies.  Zn those cases  involving
biologically or  statistically  significant  evidence  of serious
neurotoxicological effects (e.g., paralysis, convulsions, ataxia),
virtually no consideration of exposure or other factors  should be
given in determining  the TSCA Section 8(e)-reportability of such
serious toxic  effects.   As  neurotoxicologic  observations become
more limited or as confidence in the accuracy of such observations
becomes more  uncertain, the  Section 8(e)-reportability of such
findings diminishes.  Zn some studies, for example, it may not be
possible to determine with any degree of precision if observations

                                33
-------
•uch as ataxia accurately characterize the study findings or tha
tasting laboratory simply racordad ataxia as  indicating a stata
othar than normal.  Zn tha abova casa  study, however, tha obsarvad
convulsions and ataxia vara judged by tha Agency as being sarious
naurotoxic affacts and tha other affacts (lethargy and salivation)
vara viewed as providing additional  evidence of neurotoxicity.  In
tha absence of other more serious effects, however, observations of
lethargy and/or salivation, in  and of themselves, would  not be
viewed  typically as providing reasonable support for a conclusion
of substantial risk.  Similarly,  tha section 8(e)-reportability of
effects such as convulsions or ataxia would be diminished if such
effects 1) were seen only  in moribund animals or in only one or a
few isolated cases in non-moribund animals, or 2) were found simply
to be transient rather than either  intermittent or continuous in
nature.
For the following casa study involving three tests on a "moderately
acidic" chemical,  it was reported that tha tests were "performed
during the development phase of a new product for primary use as an
industrial intermediate, with some consumer usa probable."  Zt was
also reported that the "present production quantities are therefore
quite small,  but [are] expected  to increase."  Also at issue for
this particular  casa study  is the need for EPA to 1) reaffirm its
position that results- from, .acute skin or- eye irritation tests do
not routinely warrant submission under Section 8(e)  of TSCA, 2)
discuss the reportability of skin sensitization study findings, and
3) reaffirm that lethality caused at doses indicative of extreme
toxicity or serious or prolonged  adverse effects in organs/systems
away from  the site of exposure may indeed warrant the immediate
reporting of  such  findings.
     Skin TrritatioB- Teafc
•A skin irritation assay is conducted on rabbit skin (In xixa) •  A
series of ten applications are applied to the skin of the abdomen.
After three applications, the skin is described as having moderate
degrees of hyperemia, edema and necrosis.  At the end of the 14 day
observation period,  tha skin reaction  is still present,  and now
includes scab and scar  formation.  Gross  pathological examination
reveals no systemic toxicity but does .confirm tha topical corrosive
laaion at the aita of application."

                                34
-------
     flye Irritation Teat

"An eye -irritation study is conducted in the rabbit eye. Instilla-
tion of 0.1 ml into the washed and unwashed eye elicits immediate
pain and irritation of the conjunctiva, cornea, and iris after days
1, 2, and 9.  The animal appears to not to be able to see through
the treated eye  and is sent to necropsy on day 9 because of the
advanced state of inflammation in the treated eye."
     akin Sanaitization Teat

•A guinea pig [dermal] sensitization assay is performed.  The test
material is  applied to the clipped  integument -of  10 guinea pigs
during the induction phase.  This is followed by a rest period of
10  days.   A challenge  application is  applied to  a previously
untreated skin site.  The skin response is evaluated at 25 and 48
hours after application.  Eight of the 10 animals are considered to
have been sensitized by the test material based  on the presence of
erythema at the challenge site."
     BPA Ptaeuaaion

As stated in EPA's March 16, 1978 Section 8(e)  policy statement, as
well as numerous Section 8(e) "status reports," the Section 8(e)-
reportability of irritation and/or corrosivity findings  from acute
animal eye or skin irritation studies is quite limited. This should
not b« interpreted to mean, however, that EPA  is not concerned in
general about the irritation/corrosion findings from such studies.
Further, previously unknown or  unexpected effects that occur and
are observed/determined during  such routine tests may have to be
submitted under Section 8(e)  if the effects are serious and meet
the reporting  criteria  outlined in Part V  of EPA's Section 8(e)
policy statement (e.g., lethality, neurotoxicity).  Therefore, when
evaluating the results of  skin and eye  irritation studies,  EPA
expects a company to consider such factors as lethal dose, pH of
the test material, the  route(s) of administration, occurrence of
unexpected serious effects (which can be determined via "cage-side"
observation or during necropsy), and the extent and pattern of the
actual or potential  exposure to the  tested chemical or mixture.
When evaluating  such information for possible TSCA Section 8(e)
reporting, the greater  the acute toxicity,  the less heavily one
should weigh the  actual or potential exposure to the test materials
and vice versa.

With  regard to  sensitization  studies,  it must  be noted that
sensitization  is  a  systemic reaction that  is manifested in many
cases locally  (i.e., directly at the site of re-exposure) but may
be manifested  also away from the site of exposure.  Further, the

                                35
-------
nature of the  reaction can vary  from slight to severe and can, in
•ome cases, result in death.  In reviewing results of sensitization
studies for submission under Section 8(e), EPA expects companies to
evaluate  a variety of factors including, but not limited to, the
severity  of the  response, the site(s) of the response, the number
of animals affected, and/or the actual or potential exposure to the
tested  chemifffll  substance(s).   Zn general,  the more  severe the
observed  sensitization  response(s)  and the greater the number of
animals affected,  the less heavily one should weigh the actual or
potential exposure to the tested chemical (s) and vice versa.
     EPA_ ConeluaIon

Based on an evaluation of the eye and skin irritation studies and
the skin sensitization study, and considering the above discussion,
it is the Agency's opinion that, based on the provided information
on current exposure, the results of these studies do not appear to
be reportable now under Section 8(e) of  TSCA* The findings may be
reportable, however, at some future date under Section 8(e); this
would depend  upon an evaluation of new information  reflecting a
significant change in the magnitude/type of exposure  and/or the
consideration of other factors  such as those previously cited.
     Case Sfcudv

•A subchronic dermal repeated dose study in rats was conducted at
doses  of 0, 100,  300,  and  1000  mg/kg.   The  tested  material is
extensively used in consumer products and exposure  to the chemical
is exclusively dermal.  A statistically significant 25% increase in
liver weight was observed at the  high dose.  A statistically sig-
nificant incidence of  clear signs of  liver pathology typical of
cirrhosis was observed at the mid and high doses.-.  The  HQAEL [ (No-
Observable-Advene-Bffeet-Level) ] was determined to be 100 mg/kg.
No other effects were observed."

As background, it warn reported that acute and range-finding data on
the tested  chemical  indicate "it is relatively nontoxic" and the
high dose,  which was chosen for the subchronic dermal study, was
the OBCO ([Organization for European Cooperation and Development) ]
recommended limit'of 1 g/kg.  Also at issue  for this case study is
the need for EPA to reaffirm its position that organ weight changes
in the absence  of  concurrent pathology may not routinely reflect
serious or  prolonged incapacitation  and that other factors (e.g.,
histopathologic findings, dose, or actual/expected  exposure, etc.)

                                36
-------
nay need to be considered in deciding whether to report such organ
weight changes.  There  is also a need to discuss and reaffirm EPA's
position-that  a  statistically  or biologically significant histo-
pathologic finding indicating a serious or prolonged incapacitation
should be immediately reported  with little if any consideration of
factors such as exposure.
         Discussion
Although an organ weight change, in an of itself, may not reflect
a serious or prolonged incapacitation, the reportability of such
a finding could depend upon an evaluation of one or more factors,
such as, but  not limited to, the overall magnitude  of the organ
weight change,  the biological significance of  the  change,  blood
chemistry,  dose,  route  of  administration,  actual  or  expected
exposure, etc.   However, the more significant the magnitude of the
organ weight  change  (e.g., severe atrophy of the testes, thymus,
kidneys), much less consideration should be given to such factors
in determining reportability of the findings.  On the other hand,
a statistically or biologically significant histopathologic finding
indicating a serious or prolonged incapacitation should be reported
with little if any consideration given to factors such as exposure.
When the histopathologic findings  are of a  less serious or less
significant nature, other relevant factors (e.g., actual/expected
exposure, dose, etc.)  should  be considered in determining the TSCA
Section 8(e)-reportability of the study results.

The subchronic dermal application case study results clearly show
a statistically significant,  dose-dependent, relatively rare, and
serious toxic effect (cirrhosis) in the liver, accompanied by a 25%
increase in liver weight in the high dose animals.
     EPA Conclusion

Based on an evaluation  of the provided toxicologic findings, and
considering the  above  discussion,  it is  EPA's  position that the
results of the subchronic dermal application study are reportable
pursuant to Section  8(e)  of TSCA.   The facts that 1) the tested
chemical is a commercial substance, and 2) consumers  are dermallv
exposed to the chemical,  simply enhance the reportability of the
observed serious toxic effects in the liver.
                              * * * *
                                37
-------
38
-------
                            APPENDIX A
This  index  is divided  into the  following  two  (2)  major areas:
*TOTiCQfiQflT*7Mi/BXPQairp« ntTPIlfW* and "QEKBPAL ISSUES.*  in using
this particular index, please note that the nuabers in the column
on the right represent the last four  (4) digits of the chronologi-
cal Section  8(e)  submission file number displayed  on all status
reports;  the ascending  numerical sequence,  therefore,  is  also
chronological.  Please note that due  to the fact that the majority
of the first  200  Section  8(e)  notices were  submitted by a single
company and EPA had asked that company for additional information
about the Section 8(e)-applicability  of the provided findings, the
Agency has chosen to not include in this index any status reports
pertaining to those first 200 notices.
               9OXTCTTY
               TOZICITT (HUMAN)
                                             0259
                                             0282
                                             0380
                                             0408
                                             0428
                                             0429
                                             0430
                                             0431
                                             0432
                                             0433
                                             0436
                                             0456
                                             0487
                                             0531
                                             0540
                                             0638
                                             0665
                                             0669
                                             0985
                                             1059
                                             0258
                                             0315
                                             0344
                                             0493
                                             0502
                                39
-------
.l-l'l "t\*
XCTCT TOXTCITT  IBIMMII  fCOM'Tj
                                    0508
                                    0612
                                    0622
                                    0632
                                    0694
                                    0885
                                    0905
                                    0929
                                    0325
                                    0653
                                    0585
                                    0369
                                    0706
                                    0815
                                    0867
                                    1041
                                    1043
                                    1065
                                    0641
                                    1041
                                    1065
                                    0234
                                    0401
                                    0503
                                    0509
                                    0583
                                    0600
                                    0619
                                    Q681
                                    0763
                                    0847
                       40
-------
                           (MTIMAL)
                                    0641
                                    0211
                                    0213
                                    0572
                                    0626
                                    0653
                                    0764
                                    0807
                                    0820
                                    0835
                                    0842
                                    0872
                                    0999
                                    1042
                                    1043
                                    0551
QBHOTOTTCTTT IT'S VITRO I

                                    0213
                                    0214
                                    0383
                                    0396

 MOTS:  Almost all of the TSCA Section 8(e) status reports
 pertaining to in vitro genotoxicity test findings contain
 the following language:

 •Although a positive In vitro genotoxicity test result,
 when considered alone,  may not be  sufficient to offer
 reasonable support for a conclusion of substantial risk
 (as that ten  is  defined in EPA's  Section 8(e)  policy
 statement ("Statement of Interpretation and Enforcement
 Policy; Notification of  Substantial Risk"  43 FR 11110;
 March 16,  1978)),  EPA does believe that such information
 is of value in assessing the possible risk(s) posed by
 exposure to the tested chemical or mixture.  Further, the
 Agency believes that a positive genotoxicity test result,
 in combination with  other  important information (e.g.,
 knowledge of the  actual/ potential exposure to and/or
 high production  of  the tested  chemical  or mixture),

                       41
-------
 suggests  the need,  in many cases,  to' conduct  further
 studies that are deaigned to determine the  toxicity of
 and/or exposure to that chemical substance  or mixture.
 EPA expects the results of such additional studies to be
 considered-also for submission pursuant to Section 8(e)
 of TSCA."

                                     0208
                                     0213
                                    0209
                                    0249
                                    0899
                                    0994
gmome
                        • *-:i'*f'. ••)•.•, • -•••>*,

                                    0255
                                    0260
                                    0277
                                    0466
                                    0566
                                    0769
                                    0209
                                    0720

                                     0358
                                     0672
                                     0681
                                     0698
                                     0701
                                     0705
                                     0835
                       42
-------
                                        0543
                                        0546
                                        0551
                                        0577
                                        0587
                                        0642
                                        0689
                                        0818
                                        0823
                                        0824
                                        0846
                                        0325
                                        0543
                                        0545
                                        0546
                                        0551
                                        0583
                                        0587
                                        0698
                                        0701
                                        0705
                                        0706
                                        0763
                                        0818
                                        0823
                                        0824
                                        0835
                                        0545
                                        0583
                                        0763
                                        0815
                                        0824
                                        0835
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                                        0818


g.  PgflTICIDB EXPORT
                                        0823

                           43
-------
*•
                               0698
                               0701
                               0705
                               0847
                               0313
                               0325
                               0358
                               0503
                               0543
                               0546
                               0572
                               0587
                               0619
                               0626
                               0653
                               0681
                               0698
                               0701
                               0704
                               0705
                               0713
                               0847
                               1041
                               1043
                               1065
                               0213
                               0369
                               0847
                               1041
                               1043
                               1065
                               0467
                               0509
                               0600
                               0641
                               0672
                               0689
                  44
-------
   ICTTJAL nrowr.KTWSK BY IPX (COMIT)
    PUBLJBHBD
tmiULTOHl
                                          0704
                                          0706
                                          0712
                                          0713
                                          0718
                                          0720
                                          0807
                                          0809
                                          0835
                                          0847
                                          0383
                                          0588
                                          0600
                                          0641
                                          0672
                                          0467
                                          0689
                                          0704
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                                          0509
                                          0706
                                          0807
                                          0835
                                 tHPOMCTO MOt

                                          0493
                                          0600
                                          0612
                                          0622
                                          0632
                                          0667
                                          0675
                                          0694
                                          0706
                                          0718
                            45

-------
H  «wT.moiI8HT9 9Q Mnnra vad BHVAWTWA BgQnTBBM KUfa f0omi|ii
                                        0720
                                        0769
                                        0797
                                        0800
                                        0813
                                        0817
                                        0824
                                        0846
                                        0856
                                        0876
                                        0884
                                        0900
                                        0905
                                        0929
                                        0466
                                        0485
                                        0494
                                        0502
                                        0508
                                        0542
                                        0566
                                        0583
                                        0600
                                        0706
                                        0712
                                        0718
                                        0720
                                        0726
                                        0769
                                        0797
                                        0800
                                        0813
                                        0815
                                        0818
                                        0823
                                        0824
                                        0835
                                        1034
                                        0551
                                        0706
                                        1043
                          46
-------
A.  8BCTZOH afSl BSPORTINa PROCEDURES
                                        0234
                                        0324
                                        0330
                                        0369
                                        0400
                                        0543
                                        0546
                                        0566
                                        0587
                                        0626
                                        0653
                                        0681
                                        0698
                                        0701
                                        0705
                                        0855
                         * * • *
                           47
-------
48
-------
                                       APPENDIX (D)i STATUS REPORTS 6Y INFORMATION TYPE
ACUTE TOXICITY (ANIMAL)
 SUBMISSION It BEHQ-0977
               BEHQ-0178
               BEHQ-0278
               8EHQ-0278
               BEHQ-0278
               BEHQ-0378-
               BEH9-0378-
               BEHQ-0478-
               8EHQ-0578
               BEHQ-0578
               BEHQ-0578-
               8EHQ-057B
               BEHQ-0578
               8EHQ-067B-
               8EH9-0678
               BEH9-0678-
               8EHQ-0678-
               BEHQ-0678
               8EHQ-0678
               BEHQ-0678
               8EHQ-0778
               8EHQ-0778
               8EHQ-0778
               8EHQ-1178
               8EHQ-0179
0004
•039 P
0050
•069
••72
0088

0092
0131
0143

0152

0199

0162 S
• 169 S
• 179

1178
•193
• 196
• 199
•204
0207
0217
•224
0227
0259
0271
H
H
N
N
N
N

H
N
H



N

N
N
H


H
H
H
N
M

N
N


8EH9-0977-0005
8EH9-0178-0041
8EHQ-027B-0062
8EH9-027S-0066
BEH9-027B-0074
0EH9-0378-0090

8EH9-0378-0094
BEH9-047B-0134
BEH9-097B-0144

8EH9-057B-0153 S

BEH4-0578-015a S

BEH9-0578-0163
BEH9-067B-0172
0EH9-067B-0176

8EHQ-067B-01B4
BEHQ-0678-0194
8EH4-0678-0197
BEHQ-067B-0200
BEH9-067B-0205
8EH9-0778-0209
BEH9-0778-0220
BEHQ-0778-0225
8EHQ-077B-0229
BEHQ-1178-0261
BEHQ-0179-0273
N
M

H
N
N

N

N

H

M


H
H

N
N
N
N
N

H
N
N


8EHQ-0377-0015
8EHQ-027B-0042
8EH9-027B-0064
8EH9-0278-0070
BEH9-037B-OOB7
8EH9-037B-0091

BEH9-0378-0103
8EH9-047B-0137
BEHQ-0578-0151

8EHQ-0578-0154 P

BEHQ-0578-0159 S

BEHQ-0578-0166
BEH9-067B-0174
8F.H9-0678-0177

8I:HQ-0678-0185
8LHQ-0678-0195
8UHQ-0678-0198
8EH9-0676-0203
8EH9-067B-0206
8I-H9-077B-0210
8EH9-077B-0222
BEHQ-0778-0226
BEH9-1178-0256
BEH9-1278-0263
8I-H9-0279-0274




N
N

M
N




M


N
M

H
M
N
fc
I/I
H
I
(/>
S
O
H
in
to
K
n
3
£
H
1-4
O
a
S
N
N
N
M
N

M

-------
                                       APPENDIX (D)i STATUS REPORTS BY INFORMATION  TYPE
ACUTE TOXICITY (ANIMAL)
 SUBMISSION It 8EH9-0479-0278
               8EH9-0579-0284
               8EH9-0979-0311
               8EH9-06S0-0347
               8EH9-0980-03t2
               BEH9-118I-0372
               8EN9-0281-0382
               BEH9-0581-0400
               8EH9-ii8i-i*i7
               8EH9-9282-0428
               8EHQ-0282-0431
               8EH9-0282-0439
               8EH9-03B2-0438 S
               8EH9-0982-0456 S
               8EH9- 1182-04*2
               8EH9-0483-047* S
               8EH9-07B3-0487 S    M
               8EH9-1083-0494      «
               8EH9-1083-0497
               BEHQ-0984-85SO
               BEH9-IOB«-05S5
               8EHQ-0485-0549 S
               8EHQ-0685-0559
8EHQ-M79-0279
8EHQ-0779-0291
8EH9-I6BO-IM9
8EHQ-l9ai-llft5
8EH9-01B1-I1BI      N
8EH9-I3BI-I392
8EH9-I881-04M S    •
BEH9-1I81-M1B
8EH9-I282-K29      N
8EHQ-02B2-H32      •
BEH9-l282-t«3«      «
8EH9-I382-I44I S
BEH9-1I82-H59
8EH9-I181-I468
8EH9-I581-I478 S
8EH9-I78J-M85 S    M
BEH9-0881-I49B
8EH9-IOBS-9495
BEH9-1283-I5I1
8EH9-I984-I9I9
8EH9-I984-I511 S    N
8EH9-12B4-0540 S    M
BEH9-0489-055B
8EH9-0785-056S
8EH9-M79-02B2 S
8EH9-0779-B296
8EHQ-I98B-0359
8EH9-I7BO-OU9
8EH9-I1B1-0381
8EH9-I581-I398
8EH9-09B1-I409
8EH9-8282-I427 S
8EH9-0282-0430
BEN9-0282-043S
8EH9-0282-04S7
8EH9-6682-0448 S
8EH9-10B2-046B
BEH9-0283-0471 S
8EH9-0583-0479 S
8EH9-07B3-0486
8EH9-09BS-D492 S
8EH9-1083-0496
8EH9-0484-0510
8EH9-0B84-052B
BEH9-1084-0532
8EH9-04B5-0S48
8EH9-0585-0556 S
8EHQ-0885-0565 S
N
N
-------
                                               APPENDIX CD)i STATUS REPORTS BY INFORMATION TYPE
VJI
ACUTE TOXICITY (ANIMAL)
 SUBMISSION It 8EHQ-09B9-B96B S
               8EH9-1189-8973
               8EHQ-1285-B379 S
               BEHQ-0186-0984
               8EHQ-8486-B396
               BEH«-e78t-8487 S
               BEH4-68B6-0621
               8EHQ-10B6-I638
               8EHQ-1186-K44
               BEH9-02B7-0693
               8EHQ-03B7-0636
               8EHQ-OJ87-0660
               BEHQ-0487-0669 S
               8EHQ-0487-0669
               8EHQ-OS87-8678
               8EH«-1087-B«9t
               8EH«-I287-87B7 S
               BEH4-038B-0723
               8EHQ-06B8-B740 $
               8EHQ-0988-B753 S
               8EH4-10B8-B762
               8EH«-0189-0779
               8EH4-0389-0788 S
               8EH9-07B9-0806 S
               8EHQ-OAB9-OaiO S
8EH4-1B89-B569
8EHQ-1185-0573
BEHQ-1285-0588
8EH9-Bi8«-8583 S
8EHQ-B4B6-0597
8EH9-87BI-Bftl9 S
BEH9-8986-8631 S
8EH4-1886-8639 S
8EH«-I18«-8647
8EH4-0287-8654
8EH9-0287-0657 S
BEHQ-0487-8661 S
BEHQ-0487-0666 S
8EHQ-OSB7-0670 S
8EHQ-8687-86BO
8EHQ-1287-B700
8EHQ-81B8-8714
8EH9-B5B8-0732
BEHQ-B7aa-8742
8ENQ-8988-B754
8EHQ-li88-876a S
8EH4-B389-8780
BEH9-B5B9-0808
BEHQ-07B9-B808 S
8EH4-OBB9-081B S
BEHQ-1089-8571 S
8EH9-1265-0378
8EHQ-I289-B5B1
BEH«-93B6-89B9 S
8EH«-84Bt-BS99
BEHQ-8784-861*
8EHQ-1086-6636 3
8EHQ-I8B6-0640 S
8EHQ-0287-B692 S
8EH9-02B7-0699 S
8EHQ-0387-0659
BEHQ-0487-0663
8EH«-84B7-06«7 S
8EHQ-65B7-0673
8EHQ-0787-0686 S
eEHQ-1287-0706
8EHQ-83BB-0721
BEHQ-86BB-8739
8EHQ-8788-0744 S
8EH9-1088-0760 S
8EHQ-1288-0778
8EHQ-83B9-B787 S
BEHQ-06B9-0803
BEHQ-0789-OB09
BEHQ-OBB9-0819 S
-------
                                                APPENDIX (D)i  STATUS REPORTS BY INFORMATION  TYPE
VJI
M
ACUTE TOXICITY (ANIMAL)
 SUBMISSION It BEHQ-0989
               BEHQ-1089-
               BEHQ-1U9
               8EHQ-12B9
               BEHQ-1289
               8EH9-0290-
               8EHO-0490
               BEHQ-0490-
               BEHO-0590
               BEHQ-0699
               BEHQ-0690
               BEHQ-0790
               8EHQ-OB90
               BEHQ-OB90
               8EHQ-0990
               8EHQ-0990
               8EHQ-0990

ACUTE TOXICITY (HUMAN)
 SUBMISSION Bt 8EH4-017B-0016
0826 S
0814 S
0841
0858
0839
0891
0920 S
0958 S
•0989 N
•1004 S
1016 S
1011 S
1040
1048 S
1057
1060 S
1068
0016 •
0040 P
0067 P N
•0077 P *
•0080 P M
•0097 N
8EHQ-1089-OB10
8EH4-1089-0817 S
8EHQ-1189-0845
BEHQ-1289-0852 S
8EHQ-B190-OB6B S
BEHO-6190-OB98
8EHQ-6499-0954 S
BEH4-0499-0959 S
BEH4-OS99-0991 S
8EH4-0690-1005 S
BEHQ-6790-1021
BEH9-0790-10S5
8EHQ-OB90-1045
8EHQ-OB9B-IB52 S
8EH4-0990-I058 S
8EH9-0990-1061
BEHO-0990-1076 S
8EHQ-017B-0018
8EHQ-0278-OOS2 P
8EHQ-B278-007S P N
8EH9-0278-0078 P N
BEHQ-027B-OOB1 P M
8EHQ-017B-0105
8EHQ-10B9-OB1S S
BEHQ~1089-OB18 S
8EMQ-1 189-0848 S
8EHQ-1289-OB57 S
8EHO-0190-OB67
8EHQ-0490-0919 S
8EHQ-6490-0957 S
BEHQ-0590-0964
8EHQ-0690-1001
8EHQ-0690-1009
8EHQ-0790-1021 S
8EHQ-0790-1016 S
8EHO-0890-1047
8EHQ-OB90-1034 S
8EHQ-0990-1059 S
8EHQ-0990-1B62
BEHQ-0990-1084
8EH«-0178-0019 P
8EHQ-0278-0061
BEHQ-0278-0076 P
8EHQ-0278-0079 P
8EN«-0178-0086
BEHQ-0478-0118 P




N









N


N
N
M
N
M
M
-------
                                                APPENDIX (0)i  STATUS REPORTS *Y INFORMATION TYPE
ui
01
ACUTE TOXICITY (HUMAN)
 SUBMISSION It BEHQ-0478
               8EHQ-0578-
               8EHQ-057B-
               8EHQ-067B-
               BEH4-0778-
               8EH«-117B-
               BEH9-1079-
               8EHQ-02BO-
               8EHQ-06BO
               BEHQ-0981-
               8EHQ-07B3-
               8EH4-03B4-
               8EHQ-1084-
               8EH9.-09B5-
               8EH4-09B6-
               8EH4-1287-
               8EH4-OBB9-
               BEHQ-OS90-
               BEHQ-0890-

ALIERCEHICITY (ANIMAL)
 SUBMISSION li BEHQ-0578-0152
               8EHQ-0678-01B4
               8EHQ-0480-OS40
               aEHQ-0682-0448  S
0138 P N
0145 N
0154 P
0181 N
0217
0260 N
0115 N
0333
0344 P M
0409
0486
0508 P M
0532
0566
0632
0700
0818 S
0905 S M
1042
0152
0184 N
8EHQ-0578-0141 M
8EHQ-0578-0146
BEH4-0578-0165
BEHq-0678-0182 P M
BEHQ-097B-023B N
8EH4-0179-0273
8EHQ-1279-0322 N
8EH4-0480-0338
8EHQ-OBBO-0355
BEH9-1182-0466 H
8EHQ-09B3-0493 S N
8EHQ-0484-0513
8EH4-1084-0535
8EHQ-0186-0585 S -
8EH«-0487-0666 S
8EHQ-068B-0736
8EHQ-1089-0832
8EHQ-0490-0929 S H
8EHQ-0990-1071
8EH4-057B-0156 N
BEHQ-0678-0185 N
8EHQ-0578-0142
8EHQ-0578-0149
8EHQ-067B-01BO
8EHQ-067B-01B4
8EHQ-1 178-0258
8EH4-OB79-0304
8EHQ-0180-0324
8EH4-0580-0341
BEHQ-0881-0407
8EHQ-0283-0471 S
BEHQ-1283-0502 P
8EHQ-0984-0529
8EH9-04B5-0552
BEHQ-OB86-0622 S
8EHQ-0487-0671
6EHQ-10B8-0755
8EHQ-0290-0885
8EHQ-0590-0991 S
8EHQ-0990-1078
8EH9-0578-OU6
BEHQ-0678-0206
M

M
N
M
M




N









N
                                                       8EIIQ-1180-0371
                                                       8EHQ-11B2-0462
8EHQ-0282-0427 S
8EHQ-02B3-0471 S
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
ALLEROENICITY (ANIMAL)
 SUBMISSION It BEHQ-IIB3-I4B2
               BEHQ-1285-1588
               BEH9-OW-B597
               BEHQ-8287-8457 S
               BEH9-B7B7-84B4 S
               8EH4-12B7-B711
               8EHQ-05B8-B733
               BEHQ- iiBB-8748 s
               BEHQ-04B9-B79S
               8EH9-0989-OB24 s
               BEHQ-12B9-OaS2 S
               8EHQ-0498-B919 S
               8EHQ-099I-1049
8EHQ-I78S-0484
8EHQ-I186-I585 S
8EH4-1U6-0647
8EH4-l487-li«l S
BEH4-I887-049I
8EH4-I18B-I712
BEH4-I48B-I739
BEH4-1288-I777
8EHQ-I58»-I7»4
8EH4-11B9-0839
8EH9-l29t-IB74
aEHQ-1790-tail
BEH9-0990-1082
BEHQ-iB83-l*90
8EH9-0384-8589 S
8EHQ-0287-0655
8EH4-0687-I480
8EHQ-1287-07IO
BEHQ-83BB-0721
aEHQ-ataa-8740 s
8EH9-1288-I778
8EHQ-8489-0802
BEHQ-11B9-OB4S
BEHQ-0291-0894
8EHQ-099I-1042
ALLERGENICITY (HUMAN)
 SUBMISSION ft 8EHQ-1177-I817 PS
               BEH«-ai7a-aa«i P
               BEH9-057B-BUS
               8EHQ-0418-I184
               BEHQ-OS79-t2BI
               BEHQ-02B2-M27 S
               8EHQ-0485-I550
               8EHQ-0786-0412
               8EH«-04B8-0728
8EH4-1177-I81B PS   N
8EH9-I278-OI81 P    •
8EH4-0478-0181      N
BEH4-0478-Q185      N
BEH4-8779-8292
BEHQ-0283-0471 S
BEH«-81B6-B9BS S
8EHQ-9886-9422 S
8EHQ-0290-OB85
8EHQ-0178-0031 P    N
BEH9-BS7B-0144
8EHQ-Q478-0182 P    H
8EH9-0279-0274
8EH9-0880-0355
BEH«-10B4-B5S2
BEHQ-BSB8-85B9 S
8EHQ-B9B7-0694      N
8EH9-D590-0991 S
-------
         ALLERGENICITY (HUMAN)
          SUBMISSION li BEHQ-0890-1039 S
                                                APPENDIX (D)i STATUS REPORTS  SY INFORMATION TYPE
VJl
ui
CELL TRANSFORMATION (IN VITRO)
 SUBMISSION It 8EHQ-1277-0022
               8EHQ-0378-BB9B
               8EH4-OS7B-S141
               8EHQ-0179-I268 S
               BEHQ-0579-82B6
               8EHQ-0579-0289
               BEH4-0280-033*
               BEHQ-0681-BtO*
               8EHQ-1081-OU8
               8EH4-OBB3-0*90
               8EHQ-1083-049B
               8EHQ-058«-OS16 S
               8EHQ-0685-0558 S
               8ENQ-0786-0613
               fiEHQ-0986-0630
               8EHQ-0690-I01B
8EHQ-0278-0071
8EHQ-0378-0100 K
8EHQ-0578-0164
8EH«-0«79-0278
8EH4-0579-0287
8EHQ-OA79-029I
8EHQ-0281-0385
BEHQ-09B1-0412
8EHQ-0982-045S
8EHQ-I083-0495
8EHQ-0484-0511
8EH9-11B4-0536
8EHQ-0785-0561 S
8EH4-0886-0620
8EHQ-0687-0679
8EHQ-0378-0094 N
BEHQ-047B-0132 N
8EH4-057B-0166
BEHQ-8479-0279
8EHQ-0579-0288
8I:H«-0779-029«
8EHQ-1280-0401 S
8EHQ-10B1-0415
8EHQ-0583-0477 S
8EH9-I083-0496
8EHQ-0484-OS12
BEHQ-1184-0537
6EHQ-0786-0610
BEHQ-0886-0621
BEHQ-0889-0814
         CHEMICAL/PHYSICAL PROPERTIES
          SUBMISSION It 8EHQ-017B-003*
                        8EHQ-0879-0301
                        8EHQ-0480-0340
                        BEHQ-1080-0366
                                              BEH«-0278-0044
                                              8EHQ-1I79-0317
                                              8EHQ-06BO-0348
                                              8EHQ-04B1-0397
8EHQ-0279-0274
BEHQ-0280-0333
BEHQ-07BO-0353
8EHQ-0382-0440 S
-------
                                               APPENDIX (0)1 STATUS REPORTS BY INFORMATION TYPE
vn
O\
CHEMICAL/PHYSICAL PROPERTIES
 SUBMISSION It BEHQ-848J-6475
CHRONIC TOXICITY (ANIMAL)
 SUBMISSION Bi 8EHQ-1277-0024 S
               BEHQ-857B-B14S
               8ENQ-867B-B282
               •EHQ-B77B-B2I9
               8EHQ-1I78-I248
               8EH4-1878-8251
               BEH9-8279-B274
               BEHQ-0779-0297
               BEHQ-84B1-9397
               8EHQ-82B3-6469 S
               8EHQ-0483-M8I
               BEHQ-10B3-B497
               8EHQ-05B4-B5I4
               8EH«-0884-«32*
               BEH«-82B9-8S«5 S
               BEHQ-B7B5-BS42 S
               8EHQ-0386-I592
               8EH4-07BA-I4I4 S
                       8EH4- 1086-0442
                       8EHQ-0587-0475
                       8EH4-0887-84B7
                       8EHQ-1187-0497
8EHQ-B47B-B117 M
8EH9-0378-I145
BENQ-B77B-B289
8EHQ-BB7B-B234
8EH9-1I78-02S8
BENQ-1278-8242
8EH9-M79-I281
8EH9-0979-83I5
BEHQ-9282-B439
BEHQ-B2B3-8472 S
BEHQ-8683-8483 S
BEHQ-1283-8583
BEHQ-85B4-BSI7
BEHQ-89B4-8338
BEHQ-84B5-8558
BEH«-89BS-85«7
8EH9-I486-060I
BEHQ-B7Bt-Bti4
8EHQ-0986-8424 S
8EHQ-8187-8458
8EH9-I786-0681
8EH9-OBB7-8491 S
8EH9-12B7-0704
•EH9-I578-014I
8EHQ-857B-8178
8EHQ-B77B-0212
8EH9-I878-I234
8EH9-1078-0251
8EH9-9179-I269 S
BEHQ-8579-02B3
8EH9-0580-0342
8EH«-1282-8447
8EH9-8383-047*
BEH«-8783-048B
BENQ-1883-8589
8EH«-eB84-e52S
8EHQ-1284-853B
8EHQ-8485-B5S3
8EHQ-868S-8SB3 S
8EH9-I484-0604
8EHQ-8B84-9418 S
8EHQ-8986-6625 S
8EHQ-8487-846B
8EH9-0787-0684 S
8EH9-0987-0692
8EHQ-1287-0708 S
-------
                                       APPENDIX (D)t S1A1US REPORTS BV INFORMATION TYPE
CHRONIC TOXICIIY (ANIMAL)
 SUBMISSION It 8EHQ-1287-0710
               8EHQ-0588-07JO
               8EHQ-0988-0752 S
               BEHQ-1288-0774
               BEHQ-OB89-8B12
               8EHQ-1289-OB56
               8EHQ-0290-0881 S
               8EHQ-0498-B938 S
               8EH9-0590-096B
               BEHQ-0890-1043
               8EH9-0890-1056 S
           BEH«-OIBB-071J
           BEHQ-078B-0741
           8EHQ-1088-0760 S
           8EH9-1288-0775
           BEHQ-89B9-OB22
           8EHQ-1289-0858 S
           8EHQ-IJ90-I900
           8EHQ-0«90-0952 S
           8EHQ-0590-099J S
           8EHQ-OB90-1050 S
                               BEH4-03B8-0723
                               8EHQ-8788-0745  S
                               8EHQ-1288-077J
                               8EHQ-0589-0797
                               8EH4-1189-0847
                               8EHQ-0290-087J  S
                               8EHQ-0390-09M  S
                               8EHQ-0490-0940
                               8EHQ-8790-1029
                               8EH4-0890-105S
CHRONIC TOXICITY (HUMAN)
 SUBMISSION It 8EH4-0378-009*
               8EHQ-0285-854t
               BEHQ-8586-B4B1
               8EHQ-0986-6634
               BEHQ-0987-0694
               8EHQ-1287-I701
               6EH4-OI90-OB61
               BEHQ-0190-09I5
               BEHQ-0790-1034
M
M
8EH«-OB78-'8238
8EH4-838S-0«7S
8EHQ-8SB5-83S7
8EH4-I7B6-061S
8EHQ-01B7-0651
8EH4-1187-0698
8EHQ-118B-0772
8EH«-8198-0864
8EHQ-0«90-0917
8EHQ-0990-1072
8EH4-0978-0241
BEH4-08B4-052)
8EHQ-04B6-859B
8EHQ-0986-0629
8EHQ-0887-0688
8EH4-1287-0699
BEHQ-1089-OB31
BEHQ-0290-0886
BEHQ-8490-0924
8EHQ-0990-1080 S
-------
                                       APPENDIX C0)i STATUS REPORTS UY INFORMATION TYPE
 SUBMISSION Ii 8EHQ-B4B3-8476 S
CLASTOGENICITY (IN VITRO)
 SUBMISSION It BEHQ-0579-8287
               8EH4-1082-I4M
               BEHQ-0384-I9I4 S
               8EHQ-0984-B51S S
               8EHQ-I784-I922
               8EHQ-668S-8358 8
               8EHQ-0584-0M2 S
               8EH«-8B8l-Bt21
               8EH9-118t-0ft47
               8EH«-0787-0t86 S
               8EHQ-1088-0798 S
               BEHQ-B7B9-OBOS S
               8EHQ-OB90-1051 S
           8EHQ-B779-0294
           BEHQ-B4BS-04B1
           8ENQ-1IB3-85B9
           8EHQ-B58«-051* S
           8EH«-ie84-8511 S
           8EHQ-12B5-8588
           8EHQ-B78«-0«I8 S
           8EHQ-B98ft-BISB
           8EH9-09B7-I693
           8EHQ-Q389-0780
           8EHQ-M89-08H
           8EHQ-B990-1079 S
                               8EH«-1082-0459
                               8EH4-1283-0500 S
                               8ENQ-84B«-0510
                               8EH«-B5B4-BS1B S
                               BEHQ-1284-8539
                               8EHQ-B386-059S
                               8EHQ-I786-061*
                               8EH9-1186-0646 S
                               BEHQ-07B7-B6B5
                               8EHQ-B28B-0715
                               8EHQ-I389-I791 S
                               8EHQ-1189-0847
DNA ADDUCT (IN VITRO)

 SUBMISSION Bi 8ENQ-8386-0592

DNA DAHAOE/REPAIR
 SUBMISSION Bi BEHQ-B47B-B132
               8EH«-0678-0206
               BEHQ-B579-B285
               8EHQ-058J-M77 S
               8EH9-0384-0506 S
               • • «. ')iAt
•
N
8EHQ-BS78-BI65
8EHQ-I778-1213
8EH9-B579-B288
8EHQ-B683-B481
BEHQ-I083-0509
8EIIQ-1184-0936
8EIIQ-0678-B191
8EHQ-0778-0221
BEHQ-6679-8291
8EHQ-1283-0503
8EHQ-04B4-051!
8EH«-1184-0937
M
N
-------
                                               APPENDIX CD)i STATUS REPORTS BY INFORMATION TYPE
        DNA DAMAGE/REPAIR
         SUBMISSION  I i 8EH9-B7B5-6561 S
                       8EH9-0687-0679
                       8EHQ-0288-0715
                       8EHQ-12B9-8B53 S
                                              8EHQ-8SB6-06B2 S
                                              BEHQ-1186-0646 S
                                              BEH4-B7B7-B6B5
                                              8EHQ-06BB-I737
                                              BEHQ-0898-1051 S
8EHQ-0786-061J
8EH4-B1B7-0649 S
BEHQ-0987-0692
BEHQ-B8B9-B8U
VJI
VO
DNA REPAIR (IN VITRO)
 SUBMISSION Bt 8EHQ-B288-8S34
ECOTOXICITY/AQUATIC TOXICITY
 SUBMISSION •: 8ENQ-8178-BB32
               8EHQ-0278-0059
               BEHQ-837B-818B
               BEHQ-0478-0119
               8EHQ-B478-B124
               8EH«-047B-B1S2
               8EHQ-0578-0150
               8EHQ-0678-0185
               8EHQ-0778-0223
               8EHQ-0881-0*07
               BEH9-108S-B495
               8EH9-6487-0666 S
               8EHQ-0590-0899
               8EHQ-OS90-0994
               8EHQ-0990-1083 S
                                                      BEHQ-B9BB-B3S9
8EHQ-1080-0366

M
N
N
M
M
N
N
N



M
M
BEHQ-827B-BB48
8EHQ-1277-006I N
8EH4-I378-0111 N
8EHQ-047B-0120 N
8EH4-8478-B125 N
8EHQ-OS78-0141 M
8EHQ-0678-0171 M
8EHQ-0678-0201 M
8EH«-107B-02«9
8EHQ-0783-C4B6
BEH4-B4B6-0597
8EHQ-02B8-0718 N
BEH«-0390-0906 S
BEHQ-0690-1017
8EM9-0278-0058
6EHQ-027B-0061
8EHQ-0178-01H
BEH«-0«7B-0121
BEHQ-0478-0126
8EH«-0578-OM2
BEH4-B67B-0184
8EHQ-0778-0209
8EHQ-1178-0260
8EHQ-09B3-0491 S
BEH4-02B7-06S3
8EHQ-0989-0826 S
8EHQ-0390-0908 S
8EHQ-0790-1032
M

N
M
N
N
N

N





-------
                                               APPENDIX (D)i STATUS REPORTS BY INFORMATION TYPE
        EMERGENCY INCIDENT OF ENV. CONTAMINATION
         SUBMISSION Bt 8ENQ-B37B-B8B*      •
                       8EHQ-8978-B248
                       8EHQ-B379-8277
                       8EHQ-1179-8319
                       8EHQ-85BB-8S43
                       BENQ-1182-8488      N
                       BEHQ-8788-8817
                       BEHQ-8498-B93S
8EHQ-BB78-0183
8EHQ-1B7S-0255
8EHQ-8779-029f
8EHQ-1279-0322
BENQ-B181-B37B
BEH4-B98S-B5B8
8EHQ-11B8-8749
8EHQ-B79B-1BS2
H
N
N
8EH4-B87B-0237
BEHQ-1178-0260
8EH9-8879-0300
8EHQ-1279-B329
           BEHQ-8386-8993
           BEHQ-8498-8921 S
        EHV. OCCURRENCE/RELEASE/FATE
g        SUBMISSION Bt 8EH9-1077-0008
                       8EHQ-0178-OIJ8
                       8EHQ-8278-6B54
                       8EHQ-B378-BB93
                       8EHQ-B478-BI29
                       8EHQ-0578-0168
                       8EHQ-0678-0184
                       8EHQ-0778-8209
                       8EHQ-1878-B245
                       8EHQ-1178-8258
                       BEHQ-8179-8288
                       8EHQ-8B79-8388
                       8EHQ-018I-03JO
                       8EHQ-0880-8358
                       8EHQ-0881-8487
8EHQ-1177-B813
8EHQ-827B-WJ
8EHQ-B37B-888S
BEH«-837B-eB99
8EH9-8578-8148
8EHQ-8678-0179
8EHQ-B878-81B9 P
8EHQ-8878-0237
8EH9-1678-8249
8EHQ-1178-8288
8EHQ-8379-8277
8EHQ-8979-B31B
8EHQ-8SBB-B343
8EH«-lB88-836a
8EHQ-89B1-8489
           8EHQ-617B-BB37
           8EHQ-8278-B845
           BEHQ-837B-88S9
           8EHO-0378-0110
           8EHQ-657B-B147
           8EH«-0678-018J
           8EHQ-I678-0208
           8EHQ-B97B-B248
           8EHQ-1B7B-B255
           BEHQ-1278-6264
           8EH9-0779-0299
           8EHQ-1279-B329
           8EHQ-B88B-B345
           8EH9-B181-8378
           8EH4-8981-8413
                    M
                    N
-------
                                       APPENDIX CD)i  STATUS REPORTS BY INFORMATION  TYPE
ENV. OCCURRENCE/RELEASE/FATE
 SUBMISSION It BEH4-1081-0416
EPIDEMIOLOGY/CLINICAL
 SUBMISSION li 8EHQ-1177
               8EHQ-037B
               6EHQ-0478-
               BEH4-0578-
               BEH9-0578-
               8EH9-0978-
               8EH4-02BO
               BEHQ-1080
               6EHQ-0381-
               8EHQ-0282
               8EH4-0383
               BEHQ-02B5
               8EHQ-0585
0416
0466 N
0508 P M
0593
0651
0719
076* M
0882
0911
1038
0016
0096 N
0121
0146
0168
0241
0332
0167
0190
0427 S
0473
0546
0557
BEHQ-09B2-0457
BENQ-09B1-0491 S
8EHQ-0784-0521 S
8EH4-0486-0597
BEHQ-04B7-0662
8EH4-1088-0759
8EH4-0589-0799
8EHQ-0390-0905 S N
8EH4-0490-0953
8EH4-0990-1077
8EHQ-1277-0021
BEHQ-0378-0105
8EHQ-0478-012B
BEH4-0578-0149
BEHQ-0678-0192 S
8EH4-0978-0246
8EHQ-05BO-0341
BEHQ-1180-0174 S
BEHQ-0381-0394 S
8EHQ-0382-0440 S
8EHQ-1QB3-0497
8EHQ-0485-OS51 N
8EHQ-09B5-0567
8EHQ-11B2-0462
8EHq-1083-0495
BEHQ-0985-0566
8EHQ-07B6-0617
8EHq-0487-0671
BEHQ-10BB-0761
8EH4-0989-0826 S
8EH4-0490-0921 S
8EHQ-0790-1032

8EHQ-027B-0056
8EHQ-047B-0117
BEHQ-0478-0135
8EHQ-0578-0167 P
BEHQ-0878-0230
8EH9-0379-02BO
8EHQ-1080-0366
8EHQ-0281-0382
8EH4-12BO-0401 S
8EHQ-05B2-0444
8EHQ-08B4-0523 '
BEH9-04B5-0552
BEHQ-01B6-0585 S
-------
                                        APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
 EPIDEMIOLOGY/CLINICAL
  SUBMISSION It 8EHQ-02B4-858a
                BEHQ-0586-8481
                BEHQ-B784-B4I9
                BEHQ-0984-I63«
                8EH4-MB7-I471
                BEHQ-11B7-8498
                BEHQ-8288-B722
                BEHQ-11B8-8772
                8EH9-1089-9B31
                8EHQ-8198-8Bi4
                8EHQ-0398-B919
                BEHQ-0498-8929 S
                8EH4-0890-1853
                BEHQ-099B-1072
           BEHQ-BSB6-BSB9 S
           BEHQ-B786-B611
           BEHQ-B9B6-B629
           BEHQ-1886-0641
           8EHQ-BBB7-B68B
           8EH9-1287-P699
           BEHQ-B«B8-B736
           BEH«-Baa9-BB18 S
           8EHQ-1089-B832
           8EH9-B29B-OaB4
           BEHQ-049B-0917
           8EH4-BS90-099I S
           8EHQ-B990-I049
           BEHQ-099B-1078
                               8EHQ-B484-B998
                               8EHQ-B786-B612
                               8EHQ-B9B4-8432
                               8EHQ-B187-B451
                               8EH4-B987-B494
                               8EHQ-I287-B701
                               BEHQ-1BBB-B7S9
                               8EH«-0989-aB2! S
                               8EHQ-B190-BB43
                               8EHQ-B39I-0905 S
                               BEHQ-0490-B924
                               BEH9-079I-10M
                               BEHQ-0990-1B71
                               8EHQ-0990-10BO S
 GROUNDUATER CONTAMINATION

  SUBMISSION Bt BEH9-0578-IH7
                8EHQ-B1BB-B33B
                BEHQ-0962-B457
                8EHQ-0496-B953
BEHQ-099B-1077

 HUNAN EXPOSURE (ACCIDENTAL)
  SUBMISSION Bi 8EH*-i077-0008
                BEHQ-0278-8047 P
                8EH9-0278-0077 P
M
N
           8EH9-067B-01BI P
           8EH4-B48B-B34S
           BEHQ-B487-B442
8EHQ-1077-0011
8EHQ-0278-OI75 P    «
8EHQ-0278-0078 P    N
                               8EH9-0979-8318
                               8EH9-1080-OJ68
                               8EH4-1088-0759
8EHQ-0178-0038
8EHQ-027B-0074 P    M
8EHQ-0278-0079 P    N
-------
                                       APPENDIX (D)i STATUS REPORTS BY INFORMATION TYPE
HUNAN EXPOSURE (ACCIDENTAL)
 SUBMISSION It 8EHQ-0278-0080 P
               8EH4-B57B-B146
               8EH4-B678-B1BO
               8EHQ-097B-B240
               BEHQ-0379-8277
               8EHQ-1279-8322
               8EHft-8SBB-B34t
               8EHQ-B9B1-B413
               8EHQ-0384-0508 P
               BEHQ-B7B6-B617
               BEH4-1B89-BB32
               8EHQ-8498-0929 S
               BEHQ-0998-1065
8EH«-B37B-B88t      N
8EH4-B578-8M9
BEHQ-B77B-6217
8EH4-1178-U260      »
8EHQ-B879-03Q4      N
8EH4-B18B-0324
8EH4-B5B8-0343
8EHQ-10B1-0416
BEHQ-B484-8S13
8EH4-8487-0671
BEHQ-B298-B885
BEHQ-B498-B933
8EHQ-B478-0118 P
BEHQ-057B-0154 P
8EHQ-B978-0238
BEHQ-0179-0273
8EHQ-1079-0315
BEHQ-0480-0338
8EHQ-OJB1-OJ90
BLHQ-0985-0566
BEHQ-BftBB-0736
BEHQ-0390-0905 S
BEHQ-B490-0962
HUMAN EXPOSURE (MONITORING)
 SUBMISSION Bi BEH4-1277-B021
               8EHQ-0376-B110
               8EH9-B47B-B115
               BEHQ-0578-0168
               8EH4-B678-B189 P
               8EHQ-B77B-B213
               8EH«-1278-B264
               8EH4-0779-B292
               BEHQ-1179-0320
               8EH4-02SO-OJ11 S
8EHQ-0378-0096      N
8EH9-0378-8112      N
8EHQ-8S7B-8146
8EH9-057B-0170
8EHQ-8678-8208
8EHQ-0778-0219      *
8EHQ-0179-0267
8EHQ-B779-0293
8EHQ-0979-B326 S
8EHQ-03BO-0336 S
8EHQ-837B-0169
8EHQ-837B-OI13
BEHQ-8S78-0147
8EHQ-0678-0179
8EHQ-877B-0209
8EHQ-0778-022B
8EHQ-B479-0281
6EH4-B979-0310
8EH4-0180-0330
8EHQ-05BO-0343
-------
                                       APPENDIX (D)t S1ATUS REPORTS BY INFORMATION 1YPE
HUMAN EXPOSURE CHONI TORINO)
 SUBMISSION li 8EH4-04BB-8349
               8EH4-1Q80-B34B
               BEH4-B9B1-0413
               8EH4-B982-B497
               BEH«-lB81-04f9
               BEHQ-0784-1521 S
               BEH4-B2B5-05U
               BEHQ-B«89-099i
               8EHQ-Q9B5-8544
               BEHQ-I984-I433 S
               8EHQ-8487-I671
               8EH4-B2BB-S722
               8EHQ-1B8B-B761
               BEHQ-B489-B793
               8EHQ-1289-BB94
               BEH9-04»0-B»2«
               BEHQ-BB9B-1B53
BEH4-B4BB-OS4B
8EHQ-128I-OJ74
BEII4-B3B2-OMB S
8EHQ-1182-0442
B£HQ-lBB)-t4*7
BCHQ-1084-0535
BCH4-B5BS-OS47
BEH«-B«BS-055S
BEHQ-B2B4-05BB *
BEH«-12B4-044B
8EHQ-0587-0672 5
BEH«-Q48B-t73S
BEH4-02B9-07B4
8EHQ-«589-«801
BEHQ-B19B-BB4J
8EHQ-B49B-091J
BEHQ-B490-1C1B
BEHQ-B99B-1077
BEHQ-10BO-BS47
BEH4-12BB-0401 S
BEH«-B4B2-0442
BEH«-I3BJ-0473
BEMQ-IJB4-P30H
BEHQ-I1B5-I542 S
BEHQ-B4BS-B59B
BEH«-B5BS-0S5% S
BEH9-B5B4-0401
BEHQ-B4B7-0442
8EHQ-0687-0682
BEH4-09BB-0752 S
8EH9-BJB9-0789
BEHQ-IB89-0818 S
8EHQ-B290-IBB2
8EHQ-B49B-B953
BEH4-BB90-103B
BEHQ-0990-107B
HUMAN EXPOSURE (PRODUCT CONTAMINATION)
 SUBMISSION Bi BEHQ-1B77-BB12
               8ENQ-B478-B117      «
               8EH9-B778-B219      *
               BEH4-B779-B292
               BEHQ-02BB-0331 S
BEH9-S378-B104
BEM-B47B-B1S3
BEHQ-1278-0244
BEHQ-1179-012B
BEHQ-B3BB-0334 S
BEHQ-B37B-B113
BEHQ-097B-0139
BEHQ-B979-B284
BEHQ-B979-B324 S
BEHQ-04BB-034B
-------
                                               APPENDIX (D)i  STATUS  REPORTS  Br  INFORMATION TYPE
        HUNAN EXPOSURE (PRODUCT CONTAMINATION)
         SUBMISSION Bi 8EH4-0780-0352                 8EHQ-0880-0358      N          8EHQ-12AO-0376
                       8EH4-0381-0390                 8EH4-09B1-0409                8EHQ-1281-0420
                       BEHQ-0482-0442                 BEHQ-0682-0449 S               BEHQ-0283-0469 S
                       8EH4-03B3-0473                 8EHQ-0784-OS21 S               8EHQ-0185-0942 S
                       8EHQ-05B5-0554 S               8EHQ-OBS5-0564 S               8EHQ-1186-0643
                       BEHQ-1186-0644                 8EH4-028B-0720                8EHQ-0688-0735
                       8EHQ-108S-0761                 8EHQ-0589-0799                8EHQ-0689-0804
                       8EH4-0490-0962

        IHMUNOTOXICITY (ANIMAL)
^       SUBMISSION I: 8EHQ-0186-0585 S               8EHQ-03B6-0594 S               BEH«-0588-0732
^                     8EHQ-0889-08I7

        1MMUNOTOXICITY (HUMAN)
         SUBMISSION Oi 8EHQ-0290-0876

        MATERIAL SAFETY DATA SHEETS/LABELS
         SUBMISSION It 8EH«-0190-0867      *          8EHQ-0390-0903 S               8EHQ-0490-0919 S
                       8EH9-0490-094S                 8EHQ-0590-0967                BEHQ-0590-0969
                       8EHQ-0590-0983                 8EHQ-0590-0991 S               8EHQ-0590-1001 S
                       8EHQ-0690-1017                 8EHQ-0690-101B                8EHQ-0990-1062
                       8EHQ-0990-1071                 8EHQ-0990-1078

        METABOLISM/PHARMACOKINETICS (ANIMAL)
         SUBMISSION •: aEHQ-07BO-0350
       8LIIQ 1280-0401 S
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
METABOLISn/PHARMACOKINETICS (HUHANI
 SUBMISSION It 8EHQ-0578-OH9
               8EH4-0285-I546
8EHQ-0379-0277
8EHQ-04B4-0513
8EH4-9486-0600
HUTAOENICITY CIN VITRO!
 SUBMISSION It BEHQ-1177-0810
               8EHQ-I178-M3I
               8EH4-I278-M93
               8EHQ-I278-I082
               8EHQ-0478-8I27
               BEHQ-OS7B-8US
               8EHQ-0478-I1B5
               8EHQ-0778-0214
               BEHQ-1078-0254
               8EHQ-0179-8268 S
               8EH«-0«7*-827»
               8EHQ-857f-l287
               8EHQ-067f-l29l
               8EHQ-0879-I101
               8EHQ-0180-8S2B
               BEHQ-0480-BS39
               8EHQ-07BI-0551
               BEHQ-09BO-I36S
               8EH9-OZB1-0389
               8EHQ-05B1-0400
               8EHQ-0681-0404
8EH9-1277-M25
BEHQ-0278-II47
8EH4-I378-I1I2
8EH4-M78-I13*
BEHQ-9S78-IU4
8EHQ-0678-H87
BEHQ-B179-8266
8EHQ-B179-I27B
BEHQ-8579-0285
BEH9-B579-02B8
BEHQ-I779-I291
BEHQ-1179-1321
8EHQ-I260-0333
BEHQ-84B8-0340
BEHQ-B988-4359
8EHQ-1I80-0366
BEHQ-03B1-0391
BEH9-0681-0«02
BEH9-0781-0406 S
8EHQ-1277-0026 S
8EH9-027B-B051
8EH4-0278-OI73
8EH9-9378-0107
8EHQ-0578-0164
8EHQ-I67B-01B4
8EHQ-0778-0213
8EHQ-0978-0239
8EHQ-0179-0267
BEH«-8«79-0278
8EH9-0579-0286
BEHQ-8S79-0289
8EH4-0779-0294
8EH9-1279-0323
8EHQ-078I-0350
8EH4-0980-I361 S
8EHQ-0281-0383
BEHQ-O^ai-0396
8EHQ-0681-0403 S
BEHQ-0981-0412
-------
                                               APPENDIX  (0)i STATUS REPORTS 3Y INFORMATION TYPE
a\
HUTAGENICITY (IN VITRO)
 SUBMISSION It 8EH9-10B1-
               8EH9-1281-
               BEHQ-0982
               8EHQ-1082
               8EHQ-0283
               8EHQ-0583
               8EHQ-0783
               8EH9-10B3-
               8EHQ-1283
               BEH9-0484-
               8EH9-05B4-
               BEH9-0584-
               8EH9-1084-
               BEH9-1284-
               8EH9-0785-
               8EHQ-1285
               8EH9-0486-
               8EH4-0786-
               BEHQ-0886-
               8EHQ-12B6-
               8EHQ-0187
               8EH9-0687
               8EH9-0787
               8EMQ-1287
0415
0426
04SS
0460
0470
0477 S
0486
0495
050S
0510
0515 S
0519
0532
0539
0561 S
0580
0597
0608 S
0620
0645
0649 S
0677
0686 S
0706
0/19
8EHQ-1081-0417
BEH9-0282-0427 S
8EH9-0982-04S8
8EHQ-1182-0465
8EH9-0283-0471 S
8EH9-068J-0481
8EHQ-0883-0489
8EH9-10B3-0496
8EH9-0384-0506 S
BEH9-04B4-0511
8EH9-0584-0516 S
8EH9-0784-0522
8EH9-10B4-0533 S
8EH9-1284-0541 S
8EHQ-1085-0571 S
8EH9-0186-0584
8EHQ-0586-0602 S
8EH9-07B6-0610
8EHQ-08B6-0621
8EH9-1186-0646 S
8EH9-0287-0653
8EH9-0687-0679
BEH9-0987-0692
8EH9-12B7-0709 S
8EII9-068B-0737
BEH9-10B1-041B
BEH9-06B2-044B S
BEH9-10B2-0459
BEH9-01B3-0468
BEH9-0483-0476 S
BEH9-0683-0482
BEH9-08B3-0490
8EHQ-1283-0500 S
BEH9-1083-0509
8EH9-0484-0512
8EHQ-0584-0518 S
8EHQ-09B4-0530
BEH9-11B4-0537
8EH9-0685-0558 S
8EH9-1285-0579 S
BEH9-0186-05B5 S
8EH9-0786-0606 S
BEH9-0786-0613
8EH9-0986-0627
8EH9-1 186-0647
8EHQ-0287-0654
BEH9-0787-06B5
BEH9-09B7-0693
8EH9-0288-0715
BEH9-07B8-0743
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
HUTAOENICITY (IN VITRO)
 SUBMISSION It 8EHQ-10B8-B75B S
               BEHQ-03B9-B79I S
               BEHQ-08B9-BB14
               8EHQ-12B9-BBS4 S
               BEHQ-B39B-B9U S
               BEHQ-0490-I96I
               8EHQ-069I-10U S
               BEHQ-0990-1164 S
BEH9-tBBB-B7iB S
8EH4-I589-I798 S
8EHQ-B989-8B26 S
8EHQ-1289-I858 S
BEHQ-B49B-B93B S
8EHQ-B69B-10I9
BFHQ-BB9B-IBM S
8EHQ-8990-1I67
8EH4-I389-0780
8EHQ-I7S9-OB09 S
8EHQ-10B9-OBS7 S
8EH9-I390-0903 S
8EH9-049D-0932
8EHQ-0690-1015
8EHQ-B89I-1051 S
8EHQ-B990-1079 S
nUTAOENICITY (IN VIVO)
 SUBMISSION Bi BEHQ-B278-BBB2
               8EHQ-0678-B208
               8EHQ-0179-02&7
               8EHQ-0579-0288
               8EH9-1179-B321
               8EHQ-0980-B359
               BEHQ-Q381-B3S7
               8EH9-1281-B426
               8EHQ-I783-I360
               8EHQ-029B-B892
8EHQ-B378-B1B7
BEHQ-l778-p2I3
8EHQ-B579-B285
8EHQ-Bi79-B291
BEHQ-1279-0323
8EH«-1PBB-B3«»
8EHQ-8981-BU2
8EH«-B483-B47t S
BEHQ-1285-B577
8EHQ-B39B-B91* S
8EHQ-B578-0170
BEH«-1«7B-0248
8EHQ-B579-B287
8EHQ-B879-63B1
8EH9-0788-035I
BEHQ-B281-B384
BEHQ-1I81-B418
8EH9-1083-B499
8EHQ-0786-061J
8EH9-0590-0981
NEUROTOXICITY (ANIHAL)
 SUBMISSION Bi 8EHQ-1177-6BI5 S
               8EHQ-B678-B1B8
               •fMQ 0880-0356
BEHQ-027S-B05S
8EHQ-B778-B218
8EHQ-0888-8357
BEHQ-0678-0173
8EHQ-0279-0275
8EHQ-0780-0369
-------
                                               APPENDIX (D)i  STATUS REPORTS BY INFORMATION TYPE
0%
NEUROTOXICITY (ANIMAL)
 SUBMISSION Oi 8EH4-03B2-
               BEHQ-0583
               8EH4-0684-
               BEHQ-1085
               8EH9-048A-
               8EH4-0587-
               8EHQ-058B
               BEH4-07BB-
               BEH4-0489-
               BEHQ-0886-
               BEHQ-1189
               BEHQ-1169
               BEHQ-0390-
               BEHQ-0490-
               BEHQ-0490-
               8EHQ-OS90
               8EHQ-0590-
               8EHQ-0690
               8EH9-0690
               8EHQ-0890
               8EHQ-0990
0«40 S
0478 S
0520
0571 S
0599
0678
0733
0744 S
0793
0815
0841
0648 S
0898
0919 S
0936
0958 S
0964
1002
1005 ft
1041
1057
8EH4-0682-0451
BEHQ-1083-0494 H
8EH4-10B4-0532
BEH«-0186-05B4
BEH9-OBB6-0628
8EH4-1287-0706
BEHQ-0688-0739
8EH4-10BB-0757
8EH9-0489-0794 S
BEHQ-1089-OB37 S
8EHQ-11B9-0843 S
BEHQ-0190-OB67 M
8EHQ-0390-0913 S
8EHQ-0490-0931 S
BEHQ-0490-0954 9
8EHQ-0490-0959 S
8EHQ-0590-0996
8EHQ-0690-1003
BEH4-0690-1007
8EH4-0890-1043
8EHQ-0990-1063
8EH9-1182-0462
BEHQ-1283-0501
8EHQ-0585-0556 S
BEHQ-0386-0590
8EH4-0287-0655 ft
8EHQ-0188-07M
8EHQ-06B8-0740 S
8EHQ-1288-0776
BEHQ-OBB9-0611 S
8EHQ-1089-0838 S
8EHQ-11B9-OB46
8EHQ-0290-0893
8EH4-OJ90-09M S
BEHQ-0490-0934 S
BbHQ-0490-0957 S
8EHQ-0490-0963
BEH9-0590-1001 S
BEH9-0690-1004 S
BEHQ-0790-1028 S
BEHQ-0890-1052 S
6EHQ-0990-1076 S
        NEUROTOXICITY (HUMAN)
         SUBMISSION I:  BEHQ-1277-0021
                       8EHQ-057B-0146
                                              BEHQ-0378-0105
                                              8EHQ-0480-0338
BEHQ-0478-011B P
BEHQ-0786-0611
-------
                                       APPENDIX (D)i STATUS REPORTS BY INFORMATION TYPE
NEUROTOXICITY (HUMAN)
 SUBMISSION It 8EH9-10B6r66U
ONCQGENICITY (ANIMAL)
 SUBMISSION It 8EH9-0877-
               8EH9-U77
               8EH9-0178
               8EH9-8278-
               BEH9-0578
               8EM9-0578
               8EH9-8778
               8EH9-087B
               8EH9-107B
               6EH9-0279-
               8EH9-0779
               8EH9-1B79
               SEH9-018I
               8EH9-0580
               8EHQ-0988
               8EHQ-0381
               8EH9-1280
               8EH4-0981
               8EHQ-02B2
               8EHQ-0682
               8EHQ-II82
               8EHQ-02BS
8EH9-C590-8991 S
8EH9-0990-1065
0802
•016
8828
8846 N
8148
•171
•212
8236 M
8251
8274
8297
•114
8327
•142
8368
•193
1481 3
•411
•414
•447
0461
•8469 S
8EH9-1877-0006
BEHQ-1177-1019
BEH9-6178-0029
BEHQ-827B-0063
BEH9-657B-OU8
BEHQ-8678-0202
•EHQ-8/7B-8215
BEH9-897B-8246
BEH9-1078-0253
8EHQ-8479-82B1
8EH4-0979-0305
8EHQ-II79-03I6
8EHQ-8IBO-032B
8EHO.-6786-0350
8EH4-10aO-0378
aEHQ-MBl-0197
BEHQ-8681-04B2
8EH«-12ai-8422
•EHQ-1282-0419
8EH4-M82-04S1
BEHQ-1182-0461
BEHQ-828S-0472 S
8EHQ-1677-0012
8EHQ-1277-0026 S
8EH«-8278-8844
BEHQ-6478-0117
BEHQ-8578-0165
BEH9-077B-0209
. 8EHQ-8878-8234
8EH9-1 678-8248
BEH9-1278-0262
BEH9-8579-0283
8EH9-0979-OJ06
8EH9-1 179-0 318
8EHQ-84BO-8317
8EHQ-07B6-6353
BEH9-0381-03B9
8EHQ-0581-0400
8EHQ-0981-0410
8EH4-1281-6423
8EHQ-0482-6441
8EH«-8882-0454
8EHQ-12B2-6467
BEH9-83B1-0474
-------
                                       APPENDIX CD)i STATUS REPORTS dY INFORMATION TYPE
ONCOGENICITY 
-------
                                               APPENDIX (D>i STAIUS REPORTS BY INFORMATION TYPE
        ONCOOENICITY (HUNAN)
         SUBMISSION It 8EHQ-087B-0238
                       8EH4-85B2-MM
                       8EHQ-0285-BSU
                       8EHQ-0586-8401
                       8EHQ-898B-lt34
                       BEHQ-1117-11ft
                       8EH4-U88-I772
                       8EHQ-029I-I88*
                       8EH4-849B-B924
                       BEHQ-8998-1B8B S

*»       PRODUCT COMPOSITION/CHEMICAL IDENTITY
         SUBMISSION Bt BEHQ-1077-BB08
                       8EHQ-1I77-8B16
                       8EHQ-8278-BB44
                       BEHQ-8378-8885
                       8EHQ-8378-BIB4
                       BEH«-e47B-B133
                       BEHQ-0578-BiSS S    N
                       BEH9-8578-B144
                       BEHQ-0678-8187      N
                       BEH«-8778-B28f
                       8EH9-0778-I220      N
                       8EHQ-1078-0245
                       8EH9-1078-0253
8EHQ-M78-02U
8EHQ-IJ8S-I47J
8EHQ-I585-0557
8EHQ-I786-Q413
8EHQ-BI87-BI51
8EHQ-1287-8if9
8EHQ-II*B-B8«3
8EH4-IS90-I91S
BEHa-8798-1834
8EHQ-1877-8811
8EHQ-I277-BB2I
8EH9-I278-IM3
8EH9-I378-0089
8EHQ-B378-BI85
8EHQ-8578-8139
8EHQ-0578-8153
8EHQ-I578-I163
8EHQ-Q678-8208
8EHQ-8778-B214
8EHQ-0778-0228
8EHQ-1078-0249
8EHQ-1B7B-82S5
N
N
           8EHQ-0978-02U
           8EHQ-8884-B523
           8EHQ-0*86-0598
           8EHQ-0986-0629
           8EHQ-BB87-8»8B
           8EH4-1287-I7I1
           8EHQ-819B-8864
           8EH«-8«*8-8917
           8EH4-089I-1053
8EHQ-1177-OOM
8EHQ-1277-0026 S
8EHQ-B278-8654
8EHQ-0378-0093
8EHQ-B47B-B117
8EH«-0578-0150
8EHQ-0578-8163
 / '
8EHQ-0578-0169 S
8EHQ-B678-B20S
8EH9-0778-0219
BEH4-0978-0240
8EHQ-1078-0251
8EHQ-H78-0236
-------
                                       APPENDIX (D)i  STATUS  REPORTS  BY INFORMATION TYPE
PRODUCT CONPOSIT ION/CHEMICAL IDENTITY
 SUBMISSION It BEHQ-1178-0260
               BEHQ-0179-Q268 S
               8EH4-0279-0275
               8EH4-0579-8283
               6EH4-0779-0293
               8EHQ- 1179-1321
               8EHQ-828B-8331 S
               8EHQ-0380-0336 S
               BEHQ-1180-0373 S
               BEHQ-OJfll-039* S
               BEHQ-07B1-0<06 S
               8EH4-08a2-0*54
               8EHQ-0283-0471 S
               BEHQ-0683-04BO
               BEH4-07B3-0485 S
               8EH9-09B3-0492 S
               8EH9-1283-0501
               aEH«-os84-asoa
               aEHQ-0484-0513
               BEH«-05B4-0517
               8EHQ-02B5-0545 S
               BEHQ-0485-OSSS
               8EHQ-0585-0556 S
               8EHQ-0985-0568 S
N
S




S
S
S
S
S

S

S M
S

p «



S

S
S
BEHQ-117B-0261
8EH9-8179-0269 S
8EH9-0479-0278
aEHQ-8579-8288
8EIIQ-0879-0301
8EHQ-1279-0323
8EH9-02BO-0333
8EH«-0780-8350
BEHQ-1180-8374 S
8EHQ-0«1-0397
BEHQ-0482-0442
BEH9-0982-0456 S N
BEHQ-05B3-0477 S
BEHQ-0683-0483 S
BEH4-0783-0487 S M
6EH4-0983-0493 S N
BEH9-1283-0502 P M
8EH4-0484-0510
BEH«-0564-6515 S
BEHQ-OS84-05I9
8EH«-128«-05«0 S M
BEHQ-0485-0548
8EHQ-05B5-(is54 S
8EHQ-07B5-0562 S
8EHQ-10B5-0571 S
8EH9-1278-0264
BEHQ-8179-0272
BEH9-0379-02BO
BEHQ-8779-8292
8EHQ-1I79-8317
BEHQ-0180-0328
BEHQ-0380-0335 S
BEHQ-0880-035B
BEH9-1180-0375 S
BEHQ-05B1-0399
8EHQ-06fl2-0
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
 SUBMISSION It 8EHQ-I185-057*                 8EHQ-12B5-0577                 8EH9-0184-0582 S
               8EH9-0683-0583 S               BEHQ-03B6-0589 S               8EHQ-I3B6-0594 S
               8EHQ-0486-0597                 BEHQ-0586-0602 S               BEH«-06Bt-0605 S
               8EHQ-Q784-0404 S               8EH«-078t-060B S               8EHQ-0784-0609 S
               8EHQ-0784-I410                 8EHQ-B786-06M                 8EHQ-0886-0621
               8EHQ-«984-l423 S               BEH«-098t-0624 S               8EHQ-09B6-0625 S
               8EHQ-I9B4-I424 S               BEHQ-8986-0627                 8EHQ-0984-I6J1 S
               BEHQ-B9Bi-MS2                 8EHQ-I986-I633 S               BEHQ-10B6-06S6 S
               8EHQ-1886-I437                 8EHQ-1086-I639 S               BEHQ-1BB6-0640 S
               8EH«-I1B4-I«4S                 BEH«-1186-«64«                 BEH«-1186-06«6 S
               8EHQ-0187-04*9 S               8EH9-I287-0452 S               BEHQ-0287-0655 S
               8EHQ-OJ87-0454                 8EHQ-6487-OA41 S               BEHQ-04B7-0644 S
               8EH«-04B7-0«65 S    •          8EHQ-!4B7-06t7 S    N          8EHQ-04B7-044B
               8EHQ-04B7-B6«9      •          8EHQ-0487-B67B S               8EHQ-04B7-0671
               BEH«-OSB7-I«74 S               8EHQ-0687-0680                 8EHQ-t7B7-06B« S
               8EHQ-0787-0484 S               8EHQ-1187-I497                 8EHQ-1287-D707 S
               BENQ-1287-1708 S               BENQ-1287-I7B9 S               8ENQ-018B-0714
               8EHQ-0288-I714 9               8EH9-B2B8-I717 S               8ENQ-028B-0720
               8EHQ-0388-I724 S               8EHQ-I388-I725                 BEHQ-0488-0727
               8EH9-04BB-I728                 8EHQ-8488-I729 S               BEHQ-05BB-071I S
               BEH4-8588-0713                 8EIIQ-06BB-e734 S               8EHQ-068B-0735
               BEHQ-0688-0740 S               8EHQ-078B-I744 S               BEHQ-078B-0749 S
               8EHQ-09B8-B749 S               8EHQ-B9B8-875B S               8,iHQ-09B8-0751 S
               8EHQ-098B-0752 S               8EHQ-09B8-B793 S               8EHQ-1088-0755
               8EHQ-1088-0758 S               8EH«-108B-0740 S               BEHQ-1088-0761
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
 SUBMISSION •> 8EHQ-1088-0763 S               8EH9-108B-0764 S               BEHQ-I188-0765 S
               8EH9-1188-0766 S               8EH9-1188-S7t7 S               8EH9-11BB-076B S
               8EHQ-11B8-0770 S               8EH9-1188-0771 S               BEH9-12BB-0776
               8EH9-0389-B780                 BEH9-0289-07B2 S               BEH9-0289-0783 S
               8EH9-0289-6784                 BEH9-02B9-07B5 S               BEH9-0389-0787 S
               BEH9-0389-978a S               BEH9-03B9-0789                 BEH9-0389-0790 S
               8EH9-0389-B791 S               8EH9-M89-9794 S               BEH9-05B9-079B S
               8EHQ-05B9-0799                 8EH9-0689-0804                 BEHQ-07B9-OB05 S
               8EHQ-0789-OS04 S               8EHQ-I789-0808 S               8EHQ-08B9-0811 S
               8EHQ-OBB9-0816 S               8EH4-0889-0817                 BEHQ-0889-OB19 S
               8EHQ-0989-0821 S               8EHQ-0989-OB24 S               8EH9-0989-OB25 S
               8EH4-0989-0827 S               BEHQ-0989-0828 S               BEH9-10B9-0833 S
               8EHQ-1089-0814 S               8EHQ-1089-OB35 S               8EHQ-1089-0837 S
               8EHQ-1089-0838 S               BEHQ-I1B9-OB40 S               BEHQ-1I89-OB42 S
               8EH9-1189-08^3 S               8EHQ-I189-0844                 BEHQ-1189-OB47
               8EHQ-il89-08«8 S               8EHQ-1289-OB49 S               8EHQ-1289-0851 S
               8EH9-12B9-0853 S               8EHQ-1289-0854 S               BEHQ-1289-0857 S
               8EHQ-1289-0858 S               8EHQ-12B9-OB59                 BEHQ-0190-0861 S
               8EH9-0190-OB62 S               8EHQ-0190-OB65 S               BEH9-0190-OB66 S
               8EHQ-0190-0868 S               8EHQ-0190-OB69 S               8EH9-0190-0870 S
               8EH9-0190-0871 S               BEH9-0290-OB72 S               BEH9-0290-OB73 S
               8EH9-0290-0874 S               BEH9-0290-OB75 S               BEH9-0290-OB79 S
               8EH9-0290-OBBO                 8EHQ-0290-0881 S               8EH9-0290-0883 S
               8EH9-0290-OB87 S               8EH9-0290-OB88 S               BEHQ-0290-0889 S
                       r
               BEH9-0290-0890 S               8EHQ-0290-0891 S               BEHQ-0390-OB95 S
-------
                                       APPENDIX CO)i STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
 SUBMISSION 11 8EHQ-OJ90-0896 S               BENQ-0390-OB97 S               BEHQ-0390-9903  S
               BEHQ-0390-090S S    N          8EHQ-0390-090t S               BEHQ-0390-0907  S
               BEHQ-0399-090B S               BEHQ-0390-0913 S               8EHQ-0390-0914  S
               8EHQ-0390-0916 S    N          BEHQ-0490-091B S               BEHQ-0490-0919  S
               BEHQ-0490-0920 S               BEHQ-B490-I921 S               BEHQ-049B-0922  S
               BEH4-0490-I923 S               BEHQ-0490-0925 S               BEHQ-0490-092*  S
               BEHQ-0490-B927 S               BEH«-B490-B92B S               BEH«-B«9B-S929  S
               8EHQ-M9I-I93I S               BEH«-B490-B911 S               BEHQ-B490-0912
               8EHQ-B49B-I93« S               BEHQ-B49I-OCI5 S               BEHQ-0490-e93S
               BEH«-B49B-B952 S               BEHQ-B490-B95S S               BEHQ-B490-0956  S
               BEHQ-049B-B9S7 S               BEHQ-B«9B-B9SB S               BEHQ-B490-0959  S
               BEHQ-0490-B961 S               BEH4-B49I-B962                 BEHQ-059B-09B3
               BEH9-0590-09B6 S               BEHQ-0590-09B7 S               BEHQ-0590-0988  S
               8EH9-0590-I989 S               BEHQ-0590-B99B                 4EHQ-0590-0992  S
               8EH9-0590-B99S S               BEHQ-I59B-0995 S               8EHQ-0598-I997  S
               BEHQ-0590-099B S               8EHQ-I590-IOI1 S               BEHQ-0690-1004  S
               BEHQ-OI90-1B05 S               8EH«-B«90-1«I« S               8EHQ-0690-1010  S
               BEH9-B69B-1B11 S               8EHQ-I69I-1912 S               8EHQ-I690-1013  S
               8EHQ-0699-10H S               8EHQ-969I-1I16 S               BEHQ-0790-1022  S
               BEHQ-079B-1B23 S               BEHQ-B79I-1029 S               BEHQ-8790-1026  S
               8EHQ-0790-I028 S               BEHQ-0790-II29                 BEHQ-0790-1031  S
               BEH9-0790-1836 S               BEHQ-0790-I037 S               8EHQ-OB90-1039  S
               BEHQ-OB90-1042                 8EHQ-9890-104* S               8EHQ-OB90-104B  S
               8EHQ-0890-I049 S               BEHQ-0890-1051 S               BEHQ-0890-1052  S
               8EHQ-0890-1054 S               8EHQ-0890-1056 S               8EHQ-0990-1058  S
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
PRODUCT COMPOSITION/CHEMICAL IDENTITY
 SUBMISSION li 8EHQ-0990-1059 S    «
               8EH4-0990-1063
               8EHQ-0990-1071
               8EH4-0990-I07* S
               BEHQ-0990-1083 S
           8EHQ-0990-1060 S
           8EHQ-0990-1066 S
           8EHQ-0990-1073 S
           8EH4-0990-107B
                               BEHQ-0990-1062
                               BEH9-0990-1070 S
                               8EHQ-0990-1075 S
                               8EHQ-0990-1079 S
PRODUCTION/USE/PROCESS
 SUBHISSION It 8EHQ-1277-B026 S
               8EH9-0378-BIB4
               8EHQ-037B-0110
               8EHQ-0478-OI15
               8EHQ-0478-0123
               8EH9-0578-0146
               8EHQ-0578-0153
               8EHQ-057BT0159 S
               BEHQ-0578-OI64
               8EHQ-0578-0167 P
               8EHQ-0678-0179
               8EHQ-0678-B202
               8EHQ-0778-0219
               8EHQ-0978-02S9
               BEHQ-1078-0247
               8EHQ-107B-0253
               8EHQ-1276-0264
               KI •<.  oi;« o?;o
M
N
8EHQ-8378-0096
BEH9-BS78-0105
8EH9-037B-0112
8EHQ-0478-0117
BEHQ-B478-013B P
8EHQ-OS78-0148
8EHQ-Q578-0157
8EH9-B578-OU2 S
8EHQ-0578-OI65
BEHQ-057B-016B
8EHQ-0678-0180
8EHQ-0778-0209
BEH9-077B-B22B
BEHQ-1078-0245
8EHQ-1078-0251
BEHQ-1178-0256
8EHQ-0179-0267
BEH9-0179-0271
M
N
8EHQ-0378-0097
BEH4-0378-0109
BEHQ-0378-0113
8EHQ-0478-OI18 P
8EKQ-0578-0139
8EHQ-057B-0152
8EHQ-0578-015B S
8EHQ-0578-0163
BEHQ-0578-0166
8EHQ-057B-0169 S
8EHQ-067B-0200
BEHQ-0778-0217
8EHQ-087B-0230
8EHQ-097B-0246
8EHQ-1078-0252
8EHQ-1178-0261
8EHQ-0179-0268 S
8EHQ-0179-0272
-------
                                               APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
o>
PRODUCTIOH/USE/PROCESS
 SUHHISSIOH I i BEHQ-0279-1275
               BEHQ-0479-I2B2 S
               8EH9-0679-I291
               BEH9-0779-I294
               BEH9-058S-B477 S
               BEH9-06B3-I4B1
               BEH9-07BS-l4a7 S
               BEH9-0983-0493 S
               8EH9-10B3-M9*
               BEH9-12B3-I5M S
               8EH9-12BS-0503
               8EH9-0384-Q504 S
                       8EHQ-0584-I5I6 S
                       BEHQ-06B«-052f
                       8EHQ-0884-I523
                       8EH9-0884-I528
                       8EH9-1084-I5J2
                       8EHQ-1084-I533
                       8EHQ-0285-I545 S
                       8EHQ-0485-I548
                       8EHQ-0485-I551
                       eEHQ-OSBS-0554 S
                       8EHQ-0585-8557
                       AfnQ 0785 0561 S
                                           N
                                           N
                                                      8EHQ-0479-0278
                                                      8 EHQ- 057 9-028 3
                                                      8EHQ-I779-0292
                                                      8EHQ-I779-0296
                                                      8EH4-0581-0479 S
                                                      8EH9-0683-I483 S
•EHQ-10B1-04M
8EH4-10B3-0497
8EHQ-1283-05B1
8EH9- 0184 -0504
BEH«-uai-050*
8EH4-0584-0514
8EHQ-I584-0517
8EH9-I784-0521 S
8EHQ-I884-0524
8EHQ-0984-0529
8EHQ-1084-9S33 S
8EH9-I185-0542 S
8EMQ-0285-8546
8EH4-I489-0549 S
8EH4-04B3-0352
BEHQ-BSBS-0555
BEHQ-B6BS-055B S
BEHQ-0785-0562 S
BEHQ-0179-02BO
BEH9-I579-0288
8EH9-0779-0293
BEHQ-0779-0297
BEHQ-BBBS-04BO
BEHQ-I7B3-0485 S
8EH9-I9BJ-0492 S
BEHQ-IOB5-8495
BEH4-10BS-A49B
8EH9-1283-OS02 P
8EH9-0284-0505
BEHQ-0484-0510
BEH9-0584-0515 S
BEH4-B5B4-0519
BEHQ-07B4-0522
BEHQ-OBB4-052&
8EH9-0984-0531 S
BEH4-IOB4-0534
8EH4-0285-0544
8EH9-0385-0547
BEHQ-04B5-05SO
BEHQ-04B5-0553
BEHQ-05B5-0556 S
BEHQ-06B5-0559
BEHQ-07B5-0563
-------
                                       APPENDIX (0)i STATUS REPORTS BY INFORMATION TYPE
PRGDUCTIOH/USE/PROCESS
 SUBMISSION it BEHQ-oBB5-»64 s
               8EH4-d9B5-l56B S
               BEHQ-1085-0571 S
               BEHQ-1IBS-IS74
               8EHQ-12B5-I577
               BEHQ-1285-0580
               8EH9-I6B5-I3B3 S
               8EHQ-0186-I586 3
               BEHQ-0386-0591
               BEHQ-04B6-9597
               BEHQ-05B6-0601
               8EHQ-0786-0606 S
               8EH9-0786-0609 S
               BEH9-0786-I615
               aEHQ-0886-0622 S
               BEH9-09B6-0625 S
               8EHQ-09B6-0630
               8EHQ-0986-0634
               8EHQ-10B6-0637
               8EHQ-108«-06«1
               •EH9-1186-064*
               8EHQ-0187-064* S
               8EHQ-0287-0655 S
               8EHQ-0387-0659
               8EH9-0487-0664 S
8EH4-0885-0565 S
8EHQ-1085-0569
8EH4-I585-0572
8EH4-118S-0575
8EH9-1285-0578
8EH9-1285-0581
BEHQ-I186-I5B4
8EHQ-I2B6-0988      «
BEH4-0386-059* S
8EH4-0486-OS99
8EH9-0586-0602 S
8EHQ-0786-0607 S
BEH9-0786-0613
BEH4-07B6-0616
BEH4-09B6-I623 S
BEHQ-0986-0627
BEHQ-0986-0631 S
8EHQ-10B6-0635
8EH9-10B6-0639 S
BEH«-10B6-0642
BEHQ-1286-064S
8EHQ-0287-0653
8EHQ-02B7-0657 S
8EHQ-0487-0661 S
BEHQ-04B7-0665 S    N
8EH9-898S-OS66
8EHQ-10B5-0570
8EHQ-1185-0573
BEH9-1185-1576
aEHQ-1285-8579 S
8EHQ-0186-0562 S
BEHQ-01B6-05B5 S
8EH9-0386-0589 S
8EH4-04B6-OS96
8EHQ-0486-0600
8EH9-0686-0603
BEHQ-9786-0608 S
BEHQ-0786-0614
8EHQ-0886-0621
8EH«-t986-0624 S
8EHQ-0986-0629
8EHQ-0986-0633 S
8EHQ-1086-0636 S
8EHQ-10B6-0640 S    «
8EH9-1I86-0643
BEH9-1286-0648
8EHQ-0287-0654
8EHQ-0287-0658
BEHQ-0487-0663
BEH9-0487-0667 S    N
-------
                                       APPENDIX (Dli  STATUS REPORTS BY INFORMATION TYPE
PRODUCT ION/USE/PROCESS
 SUBHISSION I i BEH4-B487-86B9
               8EHQ-05B7-0672 5
               BEHC-B5B7-067S
               8EHQ-B587~8678
               8EHQ-«B7-I*82
               BEHQ-B7B7-8483
S
               8EM-0B87-I691 S
               AEHQ-lB87-8Bt5
               BEH4-1287-I7IO
               8EHA-12B7-I7I6
               AEH9-01B8-671*
               BEHQ-02B8-0717 S
               BEM-0188-0721
               BEHQ-03BB-B724 S
               BEH4-05BB-I73I
               BEH«-I5BB-B7IS
               BEHQ-06BB-07SB
               BEHQ-B78B-B742
               BEHQ-QBB8-S746
               BEH4-098B-074* S
               BEHQ-10BB-075S
               8EH4-1Q8B-07SB S
               8EHQ-UBB-0763 S
                                                       BEH4-B*S7-Bt70  S
                                                       8EH9-I587-0673
                                                       8EH9-I587-0674
                                                       8EHQ-I687-0679
                                                       8EH9-0687-0683
                                                       BEHQ-I7B7-06B4  S
BEH9-B9B7-B692
8EH4-1187-I698
BEH4-12B7-B7B1
BEH9-12B7-B709 S
BEH9-B2B8-B719
8EH4-82B8-8719
BEH4-92B8-8722
BEHQ-B3BB-B725
8EHQ-I5B8-0731 S
BEH«-BftBB-B7J4 S
BEH9-BfcBB-B7S9
BEH9-B7BB-B744 S
BEHQ-8BBB-8747
               S
               S
BEH«-lBBB-0756
BEHQ-10B8-C759
BEHQ-llBB-fl7«S S
                               BEHQ-0467-Bi71
                               BEHQ-6587-B674  S
                               8EH4-0687-K77
                               8EHQ-I4B7-06&0
                               BEH9-B7B7-B«B4  S
                               8EH4-OA87-06B7
BEH4-09B7-0694
BEHQ-12B7-0699
BEHQ-12B7-B704
8EHQ-1287-07IO
BEHQ-02BB-B716 S
8EHQ-0288-0720
8EHQ-B3BB-9723
BEHQ-B4BB-0729 S
8EH4-0588-0732
8EH4-0688-0735
BEH«-ataa-Q74o s
BEH4-B7BB-874S S
BEHQ-09BB-074B
8EHQ-098B-075I S
                                                                                     BEHQ-10BB-B757
                                                                                     BEH«-10BB-B7«B S
                                                                                     BEHQ-11BB-B766 S
-------
                                               APPENDIX (0)i  STATUS REPORTS BY INFORMATION  TYPE
CD
PRODUCTION/USE/PROCESS
 SUBMISSION Ii BEHQ-1188
               8EHQ-U88
               8EHQ-1288
               8EHQ-0289
               BEHQ-0289
               BEH9-OJ89
               BEH9-04B9-
               8EHQ-0589-
               8EHQ-0689-
               8EHQ-07B9-
               8EHQ-0889
               8EH9-OBB9-
               8EHQ-0889-
               8EH9-0889-
               BEH9-0989-
               8EH3-0989
               8EH9-1089-
               8EHQ-1089
               8EH9-10A%-
               8EH9-11B9-
               8EHQ-1189
               8EHQ-1289
               8EHQ-1289
               8EHQ-1289
               BEH4-0190
-0767 S
-0771 S
-0778
-0782 S
-0785 S
-0789
-0792
-0798 8
•MM
•0806 S
-0810 S
-0814
-0817
-0820
-0824 8
-0827 S
•0831
•0834 S
•0838 S
-0841
-0845
-0849 S
i
-0852 S
-0856
I
-0861 S
BEH9-1188-0760 S
BEH9-1288-0775
8EH9-0189-0779
8EH9-0289-0783 S
BEH9-03B9-07B7 S
.:BEH9-0389-0790 S
BEH9-0489-0793
BEHQ-0589-1799
BEHQ-068|,-0804J
BEH9-0789-OB07 S
8EH9-0889-0811 S
BEH9-OBB6-0815
8EH9-0889-OB1B S
8EH9-0989-0821 S
BEH9-0989-0025 S
BEH9-0989-082B S
8EH9-1089-OB32
8EH9-10B9-0035 S
8EH9-1189-0839
8EHQ-1189-0842 S
8EH9-1 189-0847
8EH9-1289-0850

8EH9-12B9-0853 S
BEHQ-1289-0857 S

8EH9-0190-0862 S
8EH9-1188-0770 S
8EH9-1288-0776
BEHQ-0189-0781 S
8EH9-02B9-0784
8EH9-0389-078B S
8EH9-0389-0791 S
BEH9-04B9-0794 S
8EH9-058 9-0800
8EH9-0789-0805 S
8EH9-0789-OBOB S
8EH9-0809-0013
BEH9-OBB9-0816 S
BEH9-0889-0819 S
8EH9-0989-0823
BEH9-0909-0026 S
8EH9-10B9-OB29
8EN9-1089-0833 S
«EH9-1089-0036
8EHQ-11B9-0840 S
BEH9-1189-0843 S
BEH9-11B9-084B S
8EH9-1209-0051 S

8EH9-1289-OB54 S
8IEH9-1289-085B S

8I-H9-0190-0863
-------
                                       APPENDIX CD)i  STATUS REPORIS BY  INFORMATION  TYPE
PRODUCTION/USE/PROCESS
 SUBMISSION 81 8EH9-0190
               BEH9-0190
               8EH9-0190
               8EH9-0290
               8EH9-0290
               8EH9-0299
               8EH9-0290
               8EH9-0290
               8EH9-0390
               8EH9-0390
               8EH9-OJ90
               8EH9-0390
               8EH4-0490-
               BEH9-0490
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-8879 9
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-9999 9
-0958 9
-8962
79971
-9979
8EH9-0190-0865 S
8EH9-0190-084B 9
8EH9-0190-OB71 9
8EH9-0290-OB75 9
8EH9-0290-OB61 9
8EH9-0290-08B5
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8EH9-0290-OB88 9
8EH9-0290-0891 9
8EH9-0390-0899 •
8EH9-OJ90-0902
8EHQ-8398-8911 9
8EH9-0190-09U S •
8EH9-0490-0919 9
8EH9-0490-0926 9
8EHQ,-BW-0931 9
8EH9-0490-093* S
8EHQ-9499-89S7
8EHQ-8498-8948
8EHQ-849B-B944
8EHQ-8498-8991
8EH«rB49B-8996 9
BEH«re«99-B999 9
8EHQ-8998-B964
8EHQ-OS9B-B972
8EH9-0590-0976
BEHQ-8198-8866 S
8EH9-0190-0869 S
8EH9-0290-0872 S
BEHQ-8299-8877
8EH9-0290-0682
8EH9-0290-0886
8EH9-0290-OB89 S
BEHQ-B290-0894
8EM9-0390-0900
8EH9-0390-0903 S
BEHQ-B390-0914 S
8EHQ-0490-0917
BEHQ-8498-8924
8EH9-0490-0928 S
BEHQ-8498-8932
BEHQ-8496-0939 S
8EH9-OS90-0938
BEHQ-0498-8941
BEH4-0490-0949
BEHQ-6<9e-69S4 S
8EHQ-0490-0997 S
BEH«-8490-8968
8EH9-0590-0968
BEHQ-B59B-0974
8EH9-0590-0981
-------
                                              APPENDIX  (D): STATUS REPORTS BV INFORMATION TYPE
o>
Vri
PRODUCTION/USE/PROCESS
 SUBMISSION Ii 6EHQ-0590-09B3
               8EH9-0590-0994
               8EHQ-0590-0997 S
               BEH4-0590-1001 S
               BEH4-0690-100* S
               8EHQ-0690-1I10 S
               8EHQ-0690-m3 S
               BEHt-0690-llU 9
               8EHQ-079B-1021
               8EHQ-0790-U25 S
               8EHQ-0790-102B S
               8EHQ-0790-1033
               8EHQ-0790-1037 S
               BEHQ-OB90-IOU
               8EHQ-OB90-1044 9
               BEHQ-0890-1047
               BEHQ-OB90-1050 S
               8EH«-OB98-lfl54 S
               8EH4-0990-K58 S
               8ENQ-0990-1U2
               BEH4-0990-1066 S
               8ENQ-0990-1I71
               SEHQ-8990-U7*
               8EHQ-0990-1078
               8EHQ-0990-1081
 8EHQ-OS90-0985
 8EHQ-0590-0995  S
 8EHQ-0590-0998  S
 8EH9-0690-1002
 8EH9-0690-1005  3
 8EHQ-0490-1011  S
 8EHQ-0690-10M  S
.8EH4-0690-1018
 8EHQ-0798-102J  S
 8EH«-0790-1026  S
 8EHQ-0790-1029
 8EHQ-0790-1034
 8EHQ-0890-10J9  S
 BEHQ-0890-1042
 BEHQ-0890-1045
 8EHQ-OB90-1048  S
 8EHQ-0B9B-1052  S
 8EHQ-OB90-10S5  S
 BEHQ-0990-1060  S
 8EHQ-I990-106S
 8EHQ-0990-1069
 8EHQ-0990-1072
 8EH4-099I-1075  S
 BEHQ-0990-1079  S
 8EHQ-0990-1083  S
6EHQ-0590-0992 S
8EHQ-0590-0996
8EKQ-069I-0999
8EHQ-069I-1003
8EH9-0690-I006 S
BEHQ-OitO-1012 S
8EHQ-0690-1015
8EHQ-0690-1019
8EHQ-I790-1024
BEHQ-0790-1027
8EHQ-0790-1031 S
8EH9-0790-1036 S
8EH9-0890-1040
8EHQ-0890-1043
8EMQ-0890-1046
8EH4-OB90-1049 S
8EHQ-0890-1053
8EHQ-0890-1056 S
BEHQ-0990-1061
8EH9-0990-1065
8EHQ-0990-1070 S
8EHQ-0990-1073 S
8EHQ-0990-1076 S
8EHQ-0990-10BO S
-------
APPENDIX C0)i STATUS REPORTS BY INFORMATION TYPE
REPORTING RATIONALE
 SUBMISSION Bi 8EHQ-1078-8249
               8EHQ-1083-0494      N
               BEH9-12B7-0704
               8EH4-OB89-BB13

REPRODUCTIVE TOXICITY/TERATO. CANIMAL)
 SUBMISSION It 8EH4-1B77-III7
               8EH4-0378-0095      M
               BEH4-047B-0122      M
               8EHQ-0578-OI4I S    H
               8EH9-0678-0208
               8EHQ-0978-0244
               BEH9-107B-0248
               BEHQ-0179-0269 S
               8EHQ-118I-8373 S
               8ENQ-01B1-B379
               BEHQ-03B1-038B S

               8EHQ-1281-8424
               8EHQ-04B2-845I
               8EH9-1182-I444
               8EHQ-10B3-l49f
               BEH4-OBB4-8528
               8EHQ-01B5-I543
               8EHQ-048S-0548
8EH9-BB8B-B358
8EH9-I384-I588 P
8EHQ-84B8-I729 S
BEH4-OAfi-|81S
8EH4-1277-F027
8EHQ-I378-OI81
8EHQ-B478-0129
8EHQ-947B-B18S
8EH4-B77B-I289
BEH4-1 078-820
8EHQ-1I78-0252
8EHQ-0779-I293
8EHQ-I1BI-8374 S
8EHQ-8281-0384
8EHQ-I3B1-I394 S
8EHQ-MB1-0414
8EHQ-I382-I448 S
8EHQ-I8B2-I432
8EH9-I483-I475
N
N



N

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                                      BEHQ-07BS-IU5 S
                                      8EH9-8587-8672 S
                                      8EHQ-11B8-0772
                                      8EH4-0490-0933
       8EHQ-10B4-I332
       8EHQ-02B5-I544
       8EH9-05B5-0555
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8EHQ
8EH9-
BEH9-
8EH9-
8EHQ-
BEHQ-
8EHQ-
8EHQ-
BEMQ-
8EH9-
8EHQ-
8EHQ-
8EHQ-
8EHQ-
8278-8049
0378-0103
0478-0130
0478-0206
0778-0211
1078-0247
•179-0267
0480-0344
1180-0375 S
0381-0384
0581-0399
1281-0421 S
0382-0441
1182-0442
0783-0485 S
0884-0527
1084-0534
0385-0547
0785-0560
                                                          M
                                                          N
                                                          M
-------
                                                APPENDIX C0)i  STATUS REPORTS  BY  INFORMATION TYPE
        REPRODUCTIVE TOXICITY/TERATO.  (ANIMAL)
         SUBMISSION Ii  8EH9-0785-0562  S               8EHQ-1085-0570                 8EHQ-B5B5-0572
                        BEHQ-1285-0577                  8EH4-B1B6-0587                 8EH«-098ft-0621 S
                        8EHQ-09B6-862*  S               8EHQ-08B6-0628                 8tHQ-09Bi-86U S
                        8EHQ-02B7-065J                  8EHQ-P287-0658                 BEHQ-0487-am S
                        BEH«-04B7-Bft4t  S               8EHQ-0587-0672 S               BEH4-B587-0«7ft
                                 I                       ' '
                        8EH«-0687-tl682                  BEHQ-10B7-B695                 8EH9-1287-0706
                        BEHQ-I28B-I716  S               8EHQ-02B8-t717 S               8EHQ-0388-0721
                        8EH4-0384-072t       »          8EHQ-0488-0727                 BCH«-04BB-0729 S
                        8EH4-0588-873I  S               BEHQ-06B8-07S8                 BEHQ-OB88-0746
                        BEH«-09BB-B7«B                  BEH9-89BB-0749 S               BEHQ-09BB-0750 S
                        8EHQ-09BB-0751  S               8EHQ-108B-0758 S               BEHQ-1088-0760 S
o»
^                       8EHQ-1088-976*  S               8EHQ-1I88-I765 S               BEHQ-11BB-0766 S
                        8EHQ-1188-0767  S               BEHQ-I1B8-0770 S               BEHQ-1188-0771 S
                        BEH9-128B-B77B                  BEHQ-0289-6781 S               8EHQ-0289-0785 S
                        BEH9-BSB9-B7B*  S               BENQ-OJ89-8790 S               8EHQ-04B9-0792
                        8EH4-0489-0794  S               8EHQ-8789-0807 S               BEHQ-OB89-OB10 S
                        BEHQ-0889-881I  S               8EH9-Ofl89-0813                 8EHQ-OBB9-OB16 S
                        8EHQ-08B9-0620                  8EH«-0989-0821                 8EH9-0989-OB24 S
                        8EHQ-09B9-OB2S  S               8EHQ-09B9-OB27 S               8EHQ-09B9-0828 S
                        8EHQ-1089T0829                  8EH4-1089-OB35 S               BFHa-1189-0842 S
                        8EH9-1189-OB44                  BEH9-I289-OB49 S               8EHQ-12B9-OB5I S
                        8EHQ-I2B9-0852  S               8EH4-12B9-OB5S                 BEH4-1289-0858 S
                        8EHQ-0190-0861  S               8EHQ-0190-0862 S               8EH4-D190-0865 S
                        8EHQ-0190-OB68  S               BEHQ-0190-0869 S               8EHQ-0190-OB70 S
                        BEHQ-0190-0871  S               BEHQ-0290-0872 S               BEHQ-0290-087* S
-------
                                       APPENDIX CD)i  STATUS REPORTS BY INFORMATION  TYPE
REPRODUCTIVE TOXICITY/T ERATO. CANIHAL)
 SUBMISSION I i 8EHQ-0290-0873 S
               8EHQ-0290-0879 S
               8EH9-0290-8884
               8EH9-0290-I889 9
               8EH9-0290-I892
               8EH9-0390-IB97. B
               8EHQ-0390-I91I S
               8EH9-B498-0918 S
               8EH9-0490-0923 9
               aEH9-8*96-l93B S
               8EH9-Q490-0933 S
               8EH9-0490-0939
               8EH9-0490-8942
               8EHQ-6498-894S
               8EH9-049I-094B
               8EH9-049I-0951
               8EHQ-0«9B-89«| S
               BEH4-B398-09«7
               8EHQ-0590-Q97p
               8EHQ-0590-Q976
               8EHQ-0390-I979
               8EH9-OS90-I982  ,
               8EHQ-0590-I986 S
               8EHQ-0590-0989 S
8EH9-I290-I877
8EH9~0290-08B1 S
8EH9-8290-0887 9
8EH9-0290-0890 9
8EH9-I39P-I895 9
8EH9-0390-09I4
8EH9-0190-8911 9
8EH9-B49B-0922 9
8EH9-8498-0927 9
8EH9-0490-0931 9
8EH9-0490-0937
• CBJA^flAOA^AOAII
ocnjf .,11™ 99 w^v
BEm-0498-6943
8EH9-849B-8946
BEHQ-8498-8949
1I1H9-84 98-0935 9
8EH9-059I-0945
8EH9-059I-0968
8EH9-0590-I971
BEHQ-85,98-8974
8EH9^8S90-8977
8EH9-0590-I9BI
8EH9-l59a-l9B3
8EH9-8590-89B7 9
BEH9-0590-0990
8EH9-0290-OA78
8EH9-029I-I883 S
8EH9-029Q-0888 S
8EH9-8298-I891 S
8EH9-0390-0896 S
BEH9-8390-8967 S
8EH9-0390-0912 S
8EH9-0490-8923 S
8EHQ-B490-8928 S
8EH9-0490-0932
8EM9-0490-0918
8EH9-B490-0941
8EH9-8498-8944
8EH9-8498-0947
8EM9-0490-0950
8EHQ-8498-8956 S
8EH9-0598-0966
8EH9-8598-8969
8EH9-0590-0972
BEH9-8590-0975
8EH9-9590-0978
8EH9-8598-8981
BEH9-8598-09B4
8FH9-0590-0988 S
8(H9-0590-0992 S
-------
                                       APPENDIX CD)i STATUS REPORTS BY INFORMATION TYPE
REPRODUCTIVE TOXICITY/TERATO. (ANIMAL)
 SUBMISSION It 8EH9-0590-0995 S
               8EH9-0690-I999      N
               8EH9-0699-1003
               BEH9-0690-1010 S
               8EHQ-069B-1813 S
               8EH9-0799-1125 S
               8EHQ-079B-1B17 S
               BEH9-fl898-m6
                        1'  *
               8EHQ-099B-1864
8EH9-0590-0997 S
8EH9-I499-1909 3
8EH9-0690-1006 S
8EHQ-I690-I011 S
8EHQ-0690-18M S
8EHQ-0790-1026 S
8EH9-0890-1042
8EH9-I890-1Q55 S
   •i
8EIIQ-0990-1071 S
           BEHQ-0590-0998 S
           8EH9-0690-1002
           8EH4-0690-1008
           8EHQ-0690-1812 S
           BEHQ-0790-1024
           8EHQ-0790-I030
           8EH9-0890-1043
           8EHQ-0990-1063
           8EHQ-0990-1075 S
REPRODUCTIVE TOXICITY/TERATO. (HUMAN)
 SUBMISSION It 8EHQ-OB77-OOOS
               BEHQ-0«7B-012S
               8EH9-OA78-I192 B
               BEH9-OJ82-M40 S
               8EH9-I989-9821 B
8EH9-1277-0021
8EH9-M78-II28
      t
BEH«-107B-t245
BEH«-|2B6-I5BB
           8EH9-0278-0056
           BEHQ-B578-0146
           8EH9-108I-0367
           8EH9-8288-0722
SUBACUTE TOXICITY (ANIMAL)
 SUBMISSION Bi 8EH9-1277-I823
               8EHQ-B17B-BB69
               BEHQ-D67B-B1B4
               8EH9-0679-0291
               8EH9-0680-0346
               8EH9-0181-0377
               61 MO  1061-0419
8EH9-1277-M24
BEHQ-BS7B-BI57
BEHQ-B«78-OIB9
8EM9-0779-0293
8EH9-1080-0366
BEHQ-02B1-01B«
H
N
8EH9-0178-0068
8EH9-9678-0178
8EH9-0279-0274
8EH9-1279-0325
8EH9-0780-0369
8EH9-0381-0392
8CH9-0382-0438 S
-------
                                               APPENDIX  (0)t STATUS REPORTS BY INFORHA1ION TYPE
o
CD
SUBACUTE TOX1CITY (ANIMAL)
 SUBMISSION It 8EHQ-05B2-BM9
               BEHQ-0t8J-B476 S
               8EHQ-86B1-B4B4 S
               BEHQ-1BBS-B498
               BEHQ-1BB4-B532
               aEH«-8489-894t S
               BEHQ-8789-8911 S
               8EHQ-BIB4-B989 8
               BEHQ-BUt-8997
               8EHQ-07B6-84I8 S
               8EH«-1086-I«37
               BEHQ-8587-8674 S
               BEHQ-87B7-B686 S
               8EHQ-12B7-0705
               BEHQ-84B8-8727
               8EHQ-1288-9777
               8EHQ-0289-0782 S
               BEHQ-09B9-062t S
               8EHQ-029B-B8BB
               8EHQ-0«90-B926 S
               BEHQ-0690-0999
               BEHQ-069B-1B19
               8EHQ-079I-1027
               BEHQ-0790-1037 S
               f ... Ofl«0 IOSS S
8EHQ-I682-OM4 S
BEHQ-BSBS-0478 S
8EHQ-I783-OW5 S M
BEHQ-B2B4-B50S
BEHQ-10B4-0534
8EH«-B«B5-055B
8EHQ-0785-0562 S
8EH«-B3B*-IS9B
8EH9-I686-0603
BEH«-B9Bi-Oi27
8EH«-B2B7-«453
8EHQ-I687-068I
8EHQ-I287-070I
8EH4-01B8-07H
BEHQ-B68B-B734 S
8EH4-I389-B7BB
8EH«-f3B9-B789
BEH4-10B9-OB37 S
8EHQ-0290-088*
8EHQ-B496-0931 S
8EHQ-0690-1003
8EN«-B*9B-1B20
, \
8EHQ-I790-1028 S
BEHQ-OB90-104i
BEH4-OB90-105* S
8FHQ-11B2-B462
8EHQ-0683-B4B3 S
BfcNQ-lBBl-OUS
BCHQ-B6B4-B520
8FH4-0385-0547
8EH«-0589-0556 S
8EH9-IBB5-B571 S
8EHQ-0386-I591
8EHQ-B6B6-B605 S
8CHQ-B9B6-B633 S
BEHQ-04B7-0664 S
BEHQ-06B7-06B3
8EH9-12B7-0703
8EHQ-03BB-B724 S
8EHQ-1088-0757
8ENQ-B189-07B1 S
BEH4-06B9-OB03
BEHQ-I1B9-OB45
8FHQ-0398-0908 S
BEHQ-0490-0934 S
8CHQ-0698-1007
BEHQ-0790-1022 S
BENQ-0790-1833
BEH9-OB90-1046
8EHQ-0990-1061
-------
        SUBACUTE TOXICITV (ANIMAL I
         SUBMISSION It 8EHQ-0990-1062
                                               APPENDIX  (D)i STATUS REPORTS BY  INFORMATION TYPf
                                              BEHQ-899B-1878 S
                                                         8EHQ-0990-1081
o>
vo
SUBCHRONIC TOXICITY
 SUBMISSION Ii 8ENO-
               8EH9-
               8EHO
               8EH9-
               8EH9
               8EH9-
               8EH9
               8EH9-
               8EH9
               8EH9
               8EH9
               8EH9-
               8EH9
               8EHQ
               8EHQ
               8EHQ-
               8EH9-
               8EH4-
               8EH9
               6EHQ-
(ANIHAL)
1177-8014
0578-8141 S
0778-8289
0279-9275
0788-1334  :
8882-8448 S
8184-0504
8984-8529
1185-8574
0186-0586 S
1886-0635
8587-0676
0488-0729 S
0988-0748
1088-0763 S
1889-0836
1189-0846
0290-0881 S
0490-0932
0898-1849 S
                                                      8EH9-8178-803S
8EHftT087a-0231
8EH9-1079-0312
8EH4-I980-0364
8EH4-8683-6483 S
8EHQ-0384-0507
8EHQ-0785-0561 S
8EH9-1185-6576
               S
                                                      8EHQrl287-B782
                                                      BEHQpl189-9846 S
                                                      .8EHQ-1289-OB55
                                                      8EH«-6498-0930 S
                                                      .•EH9-0490-0936
                                                      8EH9-9998-1863
BEHQ-
8EH4-
8EH9-
6578-8160 S
9678-6196
0279-0274
8EHQ-
8EH9-
8EHQ-
8EH4-
8EHQ-
6281-6384
1883-6494
8884-0524
8785-6562 S
6186-6582 S
                               8EHQ-
                               8EH9
                               8EH9-
                               8EH9-
                               8EH9-
                               8EH9-
                               8EH9-
                               8EH9
                               8EH9-
                               8EH9-
     0487
     1287
     0888-
     1088-
     0889-
     1189
     0190-
     0490-
     0690-
     0990-
     6668
     0706
     6747
     0760 S
     0817
     0843 S
     0866 S
     0931 S
     1002
     1074
        TSCA 8(0 ALLEGATION
-------
                                      APPENDIX CQ)i  STA1US REPORTS BY INHUMATION  TYPE
SUIHISSION It BEHQ-I378-IM7      •          8EH4-M78-I118 P    N          BEHQ-B478-B129
              BEHQ-B478-BI3S                 8EH4-1B84-B5J2                 8EH«-B38t-B5S9 S
              8EHQ-l78t-|tU                 BEHQ-I88I-II22 S               8EH«-I»8»-I432
              8EHQ-0887-I6H                 BEH«-BfB7-B«f«      N          BEHQ-BBBf-BBlB S
              BEH«-BfBf-IB21 S               8EH9-I39I-MI5 S    N          BEHQ-B4IB-B929 S
              •EH«-B59B-Bt91 S               BEH9-B99B-1I71                 8EHQ-B99B-1B7B
-------
 THURSDAY, MARCH 16, 1978
        PART V
 ENVIRONMENTAL
   PROTECTION
     AGENCY
  TOXIC SUBSTANCES
    CONTROL ACT

Statement of Interpretation and
Enforcement Policy; Notification
    of Substantial Risk
  91
-------
11110
                                                   Nonas
[4MO-41]

   MVIIONMINTAL PIOTICnON
              AOfNCY
     Tone
             (Fiu.M».ai

            UTANCU CQMItOl AC?
AOENCY:  Environmental ProUctioa
ACTION: Statement of Interpretation
and enforcement policy.
SUMMARY: This action state* JCPA's
Interpretation of.  and enforcement
policy ""in|«i*«t"f, section  Me) of the
Toxic Substances Control Act (TSCA)
(90 BUt. 3039. 15 U.B.C.  3607). The
provisions of that section went Into
effect en-January 1.1977.
  Section Me) states that -any person
who manufactures,  prooisriri.  or dla-
        Ia cciasorcB a c&saalcal sub-
     i or mixture and who obtains In-
formation which reasonably supports
the conclusion that such substance or
mixture presents a substantial risk of
Injury to health or the environment
shall immediately Inform the Adminis-
trator of such Information  unless such
person has actual knowledge that the
Administrator has been adequately la-
      I of such information."
        The policy expressed at this
         is in effect as of the date el
DA'
FOR  FURTHER   INFORMATION
CONTACT:
  Frank  D. Kover. Assessment  Divi-
  sion. Office  of Toxic  Substances
  (WB-5S7).  Environmental  Protec-
  tion  Agency.  401  M Street  SW..
  Washington.  D.C  30460. 203-755-
  3110.
SUPPLEMENTARY INFORMATION:
On September 9.1977. the Agency pro-
posed guidance (43 FR 45363) on Its In-
terpretation of and policy concerning
the  provisions  of  section^ Me). Al-
though the proposed -guidance" was
an Interpaettve run sad statement of'


mlnlstratlve Procedure  Act (5 U.&C.
553). the Agency solicited comments
on several issues to make more  In-
formed decisions. On October IL^he

October 15 to October 3L 1*77 (43 FR
54857). On November 4,1977. a supple-
mental notice to the piopossd  guid-
ance wu published (43 FR 57744). do-
tetlng  the November IS date for  re-
porting certain  Information obtained
before 1977 and stating that a new
date would be established In the final
guidance.
  In developing  this  policy statement.
two  meetings  have been held (Febru-
 ary 1.1977. and October 26.1977) with
 selected representatives of  Industry
 and environmental and other Inter-
 ested  groups.  Comments  submitted
 pursuant to the  February 1 meeting
 were addressed In the preamble to the
 September 9 proposal. Over 100 writ-
 ten comments have  been submitted
 pursuant to the September 9 proposal
 from trade associations, businesses, en-
 vironmental  groups,  labor  unions.
 State and Federal agencies, and other
 Interested  parties.  Appendix B de-
 scribes   significant  Issues  raised  In
 these comments and the Agency's re-
 sponse to them.
  The major modifications to the Sep-

 points 1 through 7 below.
  (1) Pursuant to some question ever
 the definition  and nature  of -guid-
 ance." this document Is now described
 more accurately  as a -policy state-
 ment."  It is exempt from  the notice
 and public comment provisions of the
 Administrative Procedure Act. as mil
                      ! delayed effec-

                                the
 view that to apply- these requirements
 to officers sad employees of a business
 organization would result la in-consid-
 ered, premature reports and would un-
 fairly subject employees to conflicting
 responsibilities as Individual  respon-
 dents and as corporate agents. Other;

 view that certain employees have a re-
 sponsibility to report pertinent Infor-
 mation, and felt that the phrase "ca-
 pable of appreciating pertinent Infer-
 mation" appropriately described those
 employees.
  The  September 9  proposal  would
 have applied section Me) requirements
 to  commercial  establishments as well
 as  to employees capable of appreciat-
 ing pertinent Information, but stlpu*
 lated enforcement priorities Intended
 to encourage corporate professing and
 centralized reporting of such informa-
 tion (43 FR 43363). The intent was to
 ensure  that pertinent Information ob-
 tained  by employees Is promptly and
• appropriately considered, while  mint-
         explicative  or
                                     -•  The Agency now feels that these ob-
                                     jectives would best be served by allow-
                                     ing «•«•«•••«•«•• establishments  under
                                     certain .conditions designed to ensure
                                     full disclosure—to assume exclusive re-
                                     sponsibility for reporting to EPA any
                                     substantial-risk Information obtained
                                     by Individual officers  or employees.
                                     Accordingly,  this  policy  itstement
                                     stipulates that  individual officers and
                                     employees will  have fully discharged
                                     their section Me) obligations once they
                                     have notified the designated responsi-
                                     ble company supervisor or official of
                                     pertinent Information, provided, that
                                     the employing  company or firm has
                                     established. Internally  publicises, and
affirmatively Implements  procedures
•ovemtng such  notifications.  These
procedure!, at a minimum, must: (!)
Specify the Information that must be
reported: <2) Indicate how the notifica-
tions are to be prepared and submit.
ted: (3) note the Federal penalties for
falling  to report: and <4>  provide a
mechanism for promptly notifying of-
ficers and employees who have submit.
ted reports of the company's disposi-
tion of those reports. Including wheth-
er or not they were submitted to EPA
(and If not. Informing employees of
their right to report to EPA. as pro-
tected  by TSCA section 23). EPA be-
lieves these four criteria will ensure
prompt and appropriate processing of
pertinent Information.
  Establishment  of such  procedures
notwithstanding, all officials responsi-
ble and having authority tar the orga-
nization's execution of Its section ate)
obligations retain personal liability for
ensuring that substantial-risk iru'orma-
tics IB reported ta SPA.
  (3) The September 9 proposal stated.
In Fart III. that a person obtains In-
formation when he Is aware that it
-may suggest"  substantial risk. Nu-

Administrator's authority  to compel
the  reporting  of Information which
-may suggest"  substantial  risk. The
Administrator agrees that section Me)
'addresses Information that "reason-
ably supports the conclusion" of sub-
stantlaljrlsk and has deleted the "may
suggest** provision,  but emphasizea
that -reasonably supports the conclu-
sion': of substantial.risk la not Identi-
cal to a conclusive demonstration of
mbstamisl risk. The former typically
occurs, and must be  reported,  at an
earlier  stage. Part  VI in  this  policy
statement provides Agency interpreta-
tion of the types of Information that
            support" sucn a conclu-
                                                                            (4)N«
                                                                                     ous commenters requested
                                                                          clarification of  different aspects  of
                                                                          Part V of the  September 9 proposal
                                                                          ("Information Which Reasonably Sup-
                                                                          ports  a  Conclusion  of Substantial
                                                                          Risk")., particularly  concerning  envi-
                                                                          ronmental effects, and suggested dif-
                                                                          ferent Interpretations of what consti-
                                                                          tutes a -substantial risk". The Agency
                                                                          continues to focus In this policy state-
                                                                          ment on the effects set forth in the
                                                                          September 9  proposal,  but clarifies
                                                                          that the substantiality  of a risk is a
                                                                          function of both the seriousness of the
                                                                          effect and the probability of its occur-
                                                                          rence (see Part VX
                                                                            (5)  Numerous  eemmenters  main-
                                                                          tained that section Ke> only  applies
                                                                          prespeetlvely to Information obtained
                                                                          after January 1.1977. The Agency dis-
                                                                          agrees, as explained In the  preamble
                                                                          to  the September 9  proposal  This
                                                                          policy statement  continues  to aoply
                                                                          section Me) to Information obtained
                                                                          before  1977  of which  a person ia»
                              •VPftAl tMISTtB. VOL 41. NO. SI—TNUISOAV. MASCN It, 1*79
                                                        92
-------
been aware since January 1. 1077. In
response to requests (or clarification.
the •utement defines what constitutes
such awareness. In this manner. EPA
Intends to limit-the need  for searches
of historical records and files.
  (6) This  policy statement now pro-
vides that  any Information published
In scientific literature.  In any  lan-
guage. Is exempt If It is referred to In
abstracts published by specified  ab>
strsctlng services.
  (7) This  policy statement describes
to a new Pan X how to submit claims
of confidentiality.
  Accordingly, the Administrator's In*
terpretatlon of and policy  towards sec-
tion Me) is set forth below.
  Dated: February 24. 1878.
                 DOUOLAS COSTLS
                     Adtntnittntar.

           LDmmnoM

  The  definitions set forth In TSCA
section 3 apply to these requirements.
lr. addiUcn. the following definitions
are  provided  for  purposes el  this
policy statement:
  The  term "manufacture or
for commercial purposes' " means to
manufacture or process: (1) For distri-
bution la commerce. Including for test
marketing  purposes. (2) for  use as a
catalyst or an intermediate. (3) for the
exclusive use by the manufacturer or
          or <4) for product research
            seat.
  The term "person" Includes any nat-
ural person, corporation, firm, com-
pany, joint-venture, partnership, sole
proprietorship,  association,  or  any
other business entity, any State or po-
litical subdivision thereof, any munici-
pality, any Interstate body and any de-
partment, agency, or Instrumentality
of the Federal Government.
  The tern  "substantial-flak Informa-
tion" means Information which rea-
sonably supports the conclusion that a
chemical  substance or mixture pre-
sents a substantial risk of  Injury to
health or the environment.

     II. PEBSOHS Somner TO TBI
          subject to section  Me) re-
quirement* include both natural per-
sons and business entities engaged in
manufacturing, processing, or distrib-
uting In commerce a chemical sub*
stance or mixture. In the case of busi-
ness entities,  the president, chief ex-
ecutive officer, and any other officers
responsible and having authority for
the organization's execution of Its sec-
tion Me) obligations must ensure that
the  organization  reports substantial-
risk Information to EPA. The business
organization Is considered to have ob-
tained any information which any of-
ficer or employee capable of appreciat-
ing  the significance of that Informa-
tion has obtained. It is therefore In-
cumbent upon business,  organizations
to  establish  procedures  for expedl-
tlously  processing pertinent Informa-
tion In  order to  comply  with  the
schedule set forth In Part IV.
  Those officers  and employees  of
business organizations who are capa-
ble of appreciating the significance of
pertinent Information are also subject
to these reporting requirements. An
employing organization may relieve IU
Individual officers and employees of
any  responsibility for reporting sub-
stantial-risk  Information directly  to
EPA by establishing. Internally publi-
cizing, and affirmatively Implementing
procedures  for employee  submission
and corporate processing of pertinent
Information. These  procedures,  at a
•"'•«••""• muse (1) Specify the Infor-
mation  that officers  and employees
must submit; (2) Indicate how  such
submissions an  to  be prepared and
the fffmptnr official to whom they are
to be submitted:  (3) note the Federal
penalties for falling to report: and (4)
provide a mechanism for promptly ed-
vtslng officers and employees la  writ-
Ing of the company's disposition of the
report. 'p*t"^«"g whether or not the
report  waa submitted to EPA (and If
not Informing employees of their right
to report to EPA.  as protected  by
TSCA section 23). An employee of say
company  that has established and
publicized such procedures,  who has
Internally submitted pertinent  Infor-
mation te accordance with thiMiu  shall
have discharged  his section Me) obll-
gallon.  Establishment  of such proce-
dures notwithstanding, all officials re-
sponsible and having authority for the
organization's execution  of its section
Me) obligations retain personal liabil-
ity for ensuring  that the appropriate
substantial-risk information is report*
edtoEPA.
  Business  organizations that do not
establish such procedures cannot  re-
lieve their Individual officers and em-
ployees of the responslbllty for ensur-
ing that substantial-risk information
they obtain Is reported to EPA. While
officers and employees of such organi-
zations may also elect to submit sub-
stantial-risk information to their supe-
riors for corporate processing and re-
porting, rather than to EPA directly.
they have not discharged their Individ-
ual section  Me)  obligation until EPA
has received the Information.
  Hon.—Irrespective of t business ortutta-
Uon-s decision to ettabllah and public*-* the
procedure*, detcrtbtil above, it Is rftpnnslMe
for becoming cognizant of any MbsUiiUai-
rt-jt information obtained by lu officers and
employees, and for  iniunns that such infor-
mation to reported to EPA within IS wort-
Ins days.

m. WHXH A Pnson WILL Be RIBABBO
  AS HAVSHO OBTAINED INPOHKATIOII

  A person  obtains substantial-risk In-
formation  at the time he first comes
 Into possession of or knows of such In-
 formation.

  NOTB.-TIUS  includes   Information  of
 which a prudent  penon •Uniiarly niuaicd
 eould mMfiably be eipected to nnncta or
 have knowledge.

  An establishment obtains Informa-
 tion at the time any  officer  or  em-
 ployee capable of appreciating the sig-
 nificance of such Information obtains
 IU

 IV. RmunotarT THAT A Paso* "In-
  MXPIATXLY IHrOBM" THX AOMJIIUTBA-
  TOX

  With the  exception of Information
 on emergency  Incidents of environ-
 mental contamination (see Part V(c)l
 a penon- has "Immediately Informed"
-the Administrator If Information Is re-
 ceived by EPA not later than the 15th
 working day after the date the person
 obtained  such  Information.  Supple-
 mentary Information generated after a
 section Me)  notification should, if ap-
 propriate, be immediately  reported.
 For emergency Incidents  of environ-
 mental contamination,  a person shall
 report the Incident to the Administra-
 tor by telephone as soon ss  he  has
 knowledge of the Incident (see Part IX
 for  appropriate telephone contacts).
 The report should contain as much of
 the  information required by Part IX
 as possible. A written report In accor-
 dance with Part IX (a) through (f) Is
 to be submitted within IS days.
  Information currently In the ponej
 slon of a penon who Is subject to t9>
 porting must be reported within go
 days of publication of this policy state-
   V. WHAT Consul u us SUBSTANTIAL
                RISKS

   A  "substantial risk of  Injury to
 health or the environment" Is a risk of
 considerable  concern because of  (a)
 the seriousness of the effect (see Sub-
 parts (a),  (b). and (O below for an Il-
 lustrative  list of effects  of concern].
 and (b) the fact or probability of lu
 occurrence. (Economic or social bene-
 fits of use. or costs of restricting use.
 are not to be considered in determin-
 ing whether a risk  Is "substantial".)
 These two criteria an  differentially
 weighted for different types of effects.
 The human health effects  listed in
 Bubpart (a) below, for example, are so
 serious that relatively little weight is
 given to exposure: the men fact  the
 Implicated chemical Is  In  commerce
 constitutes sufficient evidence of expo-
 sure. In contrast, the remaining ef-
 fects listed In Subparts tb>  and ie>
 below must Involve, or be accompanied
 by the potential for. significant loeis
 of exposun  (because of general  cro
 duction  levels, persistence,  tyo.cai
 uses, common means of disposal or
 other pertinent facton).
   Note that: (I) The effe*s ou-  -~i
 below should not be reported if i: • -
                               HOtXAi IICrSTU. VOL 43. NO. SZ-TMUISOAT. MAICH It,
                                                         93
-------
11112

•pendent has actual knowledge that
the Administrator Is already Informed
of them.
   seriously  threatens
non-human organisms with large-scale
or ecologically significant population
destruction,

VL rUrmx uro Soumcxs or Inroaau-
  no» WHICH "RsASOiuavr Sorrosn
       CoKOOsxo*" or  SmsTAinut.
   tnvirenmmtat tfftett tit Wide-
tributtoa m environmental
indicated tn rnnHTt ^^n^^^^l'Hng materi-
als contained wtthia appropriate dto*
posal facilities).

            its and iadleaton of pro*
              rumulatHm heretofore
         (to the Administrator (laclud-
rag  eloaerunnitsfton m  Osh beyond

30-day  exposure or having an  n-ce-
tanol/water   partition   coefficient
greater than 39,000) should bo report*
ed when coupled with  potential for
  Information attributing any of the
effects described la Part V above to a
ciu&iCsml ttubavtsmiiosi oi" iBlztim to to b0
reported if It Is one of the types lifted
below and If It to not exempt from the
reporting requirement  by reason of
Fart VU of ***** policy statement. A
person is not to delay reporting until
he oMatns conclusive Information that
a nibstaatlal risk exists, but Is  to Im-
mediately report any evidence  which
-reasonably supports" that conclusion.
Such evidence  will generally not bo
conclusive as to the substantiality of
the risk: It should, however, reliably
ascribe the effect to the chemical.
  Information  from the  following

scribed  m Part V will often
•tfrly support" a i**nt*h*tlim of i
tial flak. Consideration of
ttvs mformaUoa before   _
only occur when It is Indicated  below.
  U> AcrtoiMd. eoiUroilsd ftodta. IB
assessing the Quality of Information!
the respondent is to consider whether
it "••'*•''•»• reliable evidence ascribing
the effect  to the chemical, Not only
!al adverse effect.
  (3) Any non-trrrtal advene effect.
heretofore unknown to the ArtnUiils*
trator.  associated  with  a  chemical
knowni  to have bioaccumulated to a
pruneiPTBTT  degree  or to be wide-
spread la environmental media.
  (4) Ecologteally slgnlflrant  changes
m species' Interrelationships; that to.
changes   la   population  behavior.
growth, survival, etc.  that  la tarn
affect other speder behavior, growth.
or survival.
  Examples Include: (I) Excessive stim-
ulation of primary producers (algae.
macmphytes) la aquatic
e«. resulting la nutrient
or eutrophicaUon. of aquatic
should final results from such i
be reported, but also preliminary re-
sults from Incomplete studies where
  (U) Interference with	
chemical cycles, such as the
cycle.
  <5) PacOe  transformation or .
datlon to a chemical havtag an
ceptable risk as defined above.
  (e) emtrynev Incidenti of rnviron*
mental contamination—Any environ-
mental contamination by a chemical
substance or mixture to which any of
  (U IB vivo experiments sad tests.
  (ID la vitro experiments sad tests.
Consideration may be given to the ex-
      i of corroborative information. U
          to reasonably support the
           that a chemical presents a
substantial risk.
  (Ill) Epidemiologies! studies,
  ttv) Environmental monitoring stud-
ies.
  (3) Jteportf concerning and JftuMes
o/  tindcrlsned. uncontrolled ctrcvm-
•fanecs. It  to anticipated here that re-
portable effects will generally occur tn
a pattern, where a significant common
feature Is  exposure  to  the chemical,
However, a single Instance of cancer.
birth defects, mutation, death, or seri-
ous Incapadtation In a human would
be  reportable U  one  (or   a  few)
ebemieaUs) was  strongly Implicated.
In  addition. It Is  possible that effects
less serious than those described la
Pan V notice la accor-
                                     dance with Part ZZib):
                                       (c) Bat been published la the sden-
                                     Utle literature and referenced by the
                                     following abstract services! (1) Agric-
                                     ola.  (3)  Biological  Abstracts.  (3)
                                     Chemical  Abstracts.  (4)  Dissertation
                                     Abstracts.  <») Index Medtcus. (6) Na-
                                     tional Technical Information Service,
                                       (d) is corroborative of well-estab-
                                     lished  adverse  effects already  docu-
                                     mented In the scientific literature and
                                     referenced as described In 
-------
  (b) Any Information the contents of
 which a person has been alerted to by
 date received after January 1.1977. In-
 cluding any -lft*oFmaUon concerning a
 chemical for which the person Is pro*
 ently  sssfislng health and  environ-
 mental effecu:
  (c) Any other Information  of which
 the penon has actual knowledge.
                                 the
  Notices thall be  delivered to
Document Control Officer.
Information Division. Office of Toxic
Substances (WH-6S7). Environmental
Protection Agency. 401 M Street SW,
Washington. D.C. 20460.  f*..*-|
  A notice should:        *•      '    ^
  (a) Be sent by certified man, or hi
any other way permitting verification::
of Its receipt by the Agency.
  (b) State ***** It to being  submitted
m accordance with section Me).
  (c) Contain the  job title,  name, ad-
dress,  telephone number, and  signa-
ture of the  penon reporting and  the
name *""* address of the manufactur-
ings processings or distributing  estab*
Ushment with which he to associated.
  (d) Identify the chemical  substance
or mixture (Including, if  known,  the
CAS Registry Number).
  (e) Summarise the advene effects
being reported, describing the nature
    the extent of the risk Involved.
  (f) Contain the spedfle source of the?
Information together with a summary
and  the source  of any available sup*
   " m fjiftifilrtal *••••
mental contamination (see Part,
a person shall report the
t_^«  ^Amttftt^fffaf by  to!
soon as he has knowledge  of the Inci-
dent (see below for appropriate tele*
phone contacts). The report should
contain as mwyfi of the Inf ormetton re*
quired by Instructions (b) through (f)
above as possible. A written report, la
accordance   with  instructions  (a>
through (f) above,  to to be submitted
within  IS  days.  Twenty-four  hour
         ' telephone numben are:
                       Nonas

          Region  X  (Waihlngtan. Oregon, Idaho,
           AlaikaH 206-443-1200.

               X CoHra-amAUTT CLAIMS

           (a) Any  person submitting a notice
          to  EPA under section Me) of TSCA
          may  assert a business confidentiality
          claim covering all or part of the Infor-
          mation contained In the notice. Any
          information covered by a claim will bo
          disclosed by EPA only to the extent.
          and by means of the procedures, set
          forth la 40 CFR Part 2 (41 PR 36902.
          September 1.1976).
           (b) If no claim  accompanies  the
         . notice at the time It to  submitted to
          EPA. the notice will be placed In aa
          opea foe to be available to the public
          without further notice to the submit-'
          ter.
           (c) To •suit a claim of confidential-
          ity for  information  contained In  a
          notice, the submitter must submit two
          coples-of the notice.
           (1)  One copy  must be complete. la
          that copy the submitter must Indicate
          what information, if any. to claimed as
          confidential oy marking the specified
          Information on each page with a label
          such  is  "confidential." "proprietary."
          or "trade secret."
           (2) If some information In the notice
          to'CtsjfDtted as confidential, the submit*
          torr9ojt submit a second  copy. The
          second copy must be complete except
          that all Information claimed as confi-
          dential  m  the first copy must bede*
              T26S.
       O (New Tors. New Jersey.
      yif*a
 Virsmta. Maryland. Delaware. District of
 Columbia). 216-«tT-sni.         "—
 Uftoa IV (Kentucky.  ~
 Carolina. South Carouna.
       V <
           Ohio.
 331S.
lUston VI (Now
313-393-
             Jslamu. 314-74S-U40.
Rcftoo vn  (Nobraska, Iowa.
Itefion VTO (Colorado.  Utah.
  Montana. Itorth Dakota. South Dakotax
  S03-S9T-3SM.
Hcfloa DC  (California.  Ntvada.
  Hawaii. Ouaml. 415 MS 6254.
                                        (1) The outside envelope should bear
                                      the same address outlined In section
                                     • rx of ****• policy statement.
                                        (2)  The  Inside envelope  should be
                                     ;,dejrty.marked "To be opened only by
                                      the OTS Document Control Off leer." •

                                     -XL Plumi To RZPOXT lafouunov

                                        Section ISO) of TSCA makes It un-
                                      lawful for any penon to fall or refuse
                                      to submit information required  under
                                      section «xe). Section 16 provides that a
                                      violation  of  section   IS  rendeis  a
                                      penon liable to the United States for
                                      a civil penalty  and possible criminal
                                      protccutlon.  Pursuant  to section  17.
                                      the  Government  may  seek Judicial
                                      relief to compel submlltal of section
                                      Me) Information and to otherwise re-
                                      strain any violation of section Me).
                                                                                                           11113

                                                                             Afrtarorg  A.— QBICT Rvnuorci  Br/tftuttr
                                                                                           IKCUUU or
                                                                                 a. wtttt movu
                                                                                                        AS «•
                                                                              An emergency Inddnt of emrlronmeatal
                                                                             eofiumlrauon is "any environmental con-
                                                                             tamination by a chemical nbcunet or -'--
                                                                             turi . . .  which, because of UM  pattern.
                                                                             tiuat sad amount of eonummuion. (I) 8o>
                                                                             rtoualy threatens human vita eanetr. bbth
                                                                             defects. mutation. death, or orrtooj or pro*
                                                                             longed  Incipifiutloa  or  (3>  otrloualy
                                                                                                        with Urse
                                                                                 or ecologically tignincant population
                                                                                 UCUOB-. (See Put Vce> for complete
                                                                             doterlpUenJ
                                                                              Information ooBUlntd to ooUfleatlen of
                                                                            spUla under MCUOD !li(bX8> of the Federal
                                                                            Water  Pollution  Control  Act  (FWFCAX
                                                                            (For a eomplou list of exemptions to report-
                                                                            Int. ate Part vnj
                                                                                              Touroni
                                                                                                 of environmental
                                                                                             to bo reporud immedl.
                                                                            auiy by telephone to the appropriate EPA
                                                                            fleelonal 24-hour toltphoaa emergency lino
                                                                              •mm eii-
                                                                                     (Ifov Tort. Hov Jersey. Puerto
                                                                                  , Virata Islands). 2ot-MS-eno.
                                                                               _  i  m (Peantylvanla, West Virginia.
                                                                              Virginia. Maryland. Delaware. DMrtct of
                                        <•! The first copy of
                                      be  disclosed  by  EPA only to  the
                                      extent. "H by  means of the prece*
                                      dures, set forth in 40 CFR Part X The
                                      second copy will be placed in aa opea
                                      me to be available to the public, „
                                       .(d),Aay penon submitting a notice
                                      containing information for which they
                                      are asserting  a ffffnfldfn***^lltT claim
                                      should  send the notice  la  a  double
                                                                              291S.
                                                                                    IV (Ktmuekr. TBUMOMO. North
                                                                                       Booth Carolina. (Hortta. -Ala*
                                                                                    ltwslaHi.il. Plorida). 404-ui-toea.
                                                                                    V  (WHcentln.  ffllnolf,  Indiana.
                                                                                                         313-3M*>
                                                                                   VX(Now-lfC
                                                                                                 . Tnaa, Oklahoma.
                                                                                      Louisiana). 214-749-3MO.
                                                                                    vn (Nebraska.  Iowa.  MlmourL
                                                                                      I16/474-J77B.
                                                                                    vm '(Colorado. Utah. Wyoming.
                                                                                       North Dakota. South Dakota).
                                                                              S09-B27-MSO.
                                                                             Reslon  IX (California. Nevada. Artsona.
                                                                              Hawaii. Guam). 419-996-62S4.
                                                                             Reslon
                                                                              In addition, a written report. In
                                                                                 with Injunctions (a) through (f> of
                                                                                 IX to to bo submitted within IS days to
                                                                             the Document Control Of fleer. Chemical In-
                                                                                      Division. Office of Tone  Sub*
                                                                                  I (WH-UT). 401 M Street SW, Wain-
                                                                             msten. D.C 20460.

                                                                              Affwntx B*>8ioinficuR Comnvn *tn
                                                                                        : Employea cannot be hrid
                                                                                    to these requlremenu.  tiner (a)
                                                                             They only havo a partial role in the manu-
                                                                             facture, prnrnilni or dUtrlbution of cneml-
                                                                             cats. (M « other acetlona of TSCA. ihe t«rm
                                                                             "person who manufacture!,  procnaei.  or
                                                                             distributes- ehemtcaU clearly relen to BU*I-
                                                                             ntai onanttauonK "penani" ihouid M ran-
                                                                             •Isunuy defined, and (e) the tppnc.i an of
                                                                             criminal penalties mandaira a itric: -^^r-
                                                                             pntauon of into word.
C"")
         See NOTE on last page of Appendix  C
              ~~"~           KOHAl UOISTH. VOL 41. NO. S3-TNUISOAT. MAICN 14. IfTS
-------
inn                                                  Nonas

  JUepoMer The Agency eontden that dlf-   matlon they have obtaln-d directly to EPA:   (corporate protecting, mailing,  holldaya.
ferent eecuone of TSCA. having dUfermt   rather, their client manufacturer*, procee-   etc.).
purpoaee. are approprle*ely~dlrected to dlf-   eon and  d'it-ibutor» are mponalble  for    fletpoaac The Agency ha* chanted the
fercnt respondent*. In the caie  of eeetloa   reporting eueh information.                 compliance period to U butine** day*, it la
Ke>. of fteen and employee* who are capable         	       	    	  	       Imperative that procedure* be establUhed to
of appreciating the ctgalf Icance of Inf orma-       *• "• oerauMwo or nrroa*uno*i       expedite the repertlng of cubatantiai-rtak In-
Uoa have a ifftuauMj«*f««£|j"»«•*    CeauaeaJ t The "may nggeat- ernertoa   formation, not that repomag conform  to
alert to and report «ub*tanual-n*a inf orma-   B p^n ni Of the nroooiat eervea to compel   extotlag proeedurea.
ueav Tho guidance haa been modified eo   tvrOMT examlnaUonofbaformattaa thatby    Coauaeai J«r Allow from M to M day* for
that natural penoni aad bmlneai enUUea   llitt| to ...  -.KJ... M MCUOB he) reeulre-   **• aeooBd phaee of reportlne alternatively.
eaa fulfill their eeetion He) obligation to   atau. The  •tatuiory language calling for   do an prcaolbo a time limit for additional
different way*. Moat officer* and  employee*   •reaioaable euaaoeV dee* not eupport tbto.   reporting,
eta dtoehano their eecuoa ate) obligation   piinriiriiiinaTS'iii rMnniii rnmrnri inr    Jtatpomer Havtng deleted the  -may ue>
by OBbmttUng pertinent information to cor-   vbm j££ iontha  »  arnreTmnef   •"*" cntertoa. the Agency *ee* no need to
                    Mad that  Uw com-   ,J3y  after  MfeuMry rarStt 4utea?   Provide  a  eocend  phaee to  the  reporting
          	UM rtak-evmiuitloa   rtuTfar *ifeii1lni ":- l-^-r r-T''"M"   period. Supplemental Information that to
    	i ebanctertoed IB Flit U. IB UM   S^d,         '     ^^             generated after * aectlon «*> notiflcatloa
     of  a bualnce* organtntioa. M pnaV    Jtaeonea* The Aeener doe* •**** mtend to   ihrilit it  irtfr"pil*tt, be  I™"**H<*H*|T re*
	. chief executive officer, and  other offl-   ,B^awtftfttTiSfftr*'-'^---''~""- of   poned.
etato reapocadbM  aad aavtag  authority (or   inf?^'tffnthat iTTlUtlf to BOA iV)«* «»    Cbwmemt It: Allow from M to 120 day* to
the '	organisation-* oeeutloa of IU   mmm «•>  reo-uiremente aad hat deleted   "wort pr*>I«f7 taformatloa: tbto period
•eeUoB Me) oMIHllnni muat enure that   m« ~^«- •"•wet* IIIIHHI   BUerpiwutkSorwhMeo^tu» evidence   Uoa. («) Jaauaryju 19Tt. obligation are   mealingbotbree-utrementa,
not be. To do ao would fore* employee* and   tBewTOduponobtaUMcce^ujorywbttan*    «e»ponat; The policy naiement preaenbe*
eiiuiiiiTUt u>la coafllctlBg poaiuona. InvtUig   tlauriak information.                       * 68 day reporting period,  commencing ua-
bueraal eorporaie dtaeniea aad over* re-     irnimoiM me Anna itliniini and eea>   rnortlitely upon publlcailon. Section ate) haa
porting, runner. ndivMuato often do not   a£rTthat 4eaaonable wpport^of a eon-   beaa to) effect *mce January 1.  1077: peat.
haeetne overview  me miry  to  reach con-   SUCMB MiubiteAUaTrLfctoM leeaueaiw   poaement  la  reporting eubatantial-ru*  la-
      , weiUuppotted dodalon. Corporate   the eonchtaton  Iteelf. The former typically   formation to not warranted.

      &&%£%&£££ ****   Eg-""*** »«-«*••••--•    o.Eme»M>aWoaMno.miyMV««
      OMK The Agency mnilrter* thai em-    CdaiaiiKl TTIn lUtnnmL in r*rt m of                  iBvovra
ploy*** have a legitimate rolein (ttk reaoru   u,. Drnnn**l that a pereoa ha* obtained b>     Cbaimenl It: The reporting of -any  tn-
mc ft to  imperative  mat rttt Information   fermatloa U be ".. . abould know of the ea-   nance"  of eaacar. birth  defect*, eife. la
obtained  by employee* bo  tppreprtaijly   btenee of tucb mfermatioa not In hto poa>   human to lea breed and *ueh mformatlon
 tanrlrtir* it. Officer* andempleyeeeMBful.   ((Htea but which would be delivered to him   will be of little UM: chemical worker*. Uk*
fUtbclr role la Uw importing of •ubeuntlal-   m  imvmt- tool  to compel aa  active   the general poputatioa, develop cancer* and
rjafc hjfotmatlon. without the diaadraauge*   ttttttt tor  Mbttaauatnak  taformatloa   other altoaeat* of uncertain etiology.
dmrnnil  abo»e. oy reporting tefenaatlOB   rathar Uiea the iwportlag of (ubataatiaMaft     JUiaoaeB- Tbto policy *uument elartflea
to  eupulor* for corporate  conldnatloa.   BfermaUOB a penon "obtain." Tbto to of   "«-« the reporting of fri1* occurrence* of
and, havmg done eg., wui_have  dUcharted   putlcular eoneem to Importer* wtth limited   numaa eancer or other atrlou*  effect* will-
	-.^	         u lafermatlOB imiiaiH by their   oepead  upoa  evMeace etrangly  implicating
            r   .r   i   fat             •  ^  .         _____  „ .                            .
           of certain proceduree tor rut-     juepewer Tho Agency eoaHden that ee»    CtowtewiU 13: Dermal allmenU and naueea
           thortby anurlBgthe approprl-   yga  ait) appUeo to Information which a  aro poorly rhnein «-M»pi— of precuner
                of weh repmitjIrtoiB of.   pg^na poaneiu or of which ho teowa. Ktt  aymptomj. Detetlag  tbeat  eucnpiee  will
                ""*JSS? SfiS^SJSi   ** *»•*•< «• •»"»* "•«»«• *•» •*•"  woM unduly omphaffttmg them when other
                  otoeutloa of  lie eeetion   anton or extraordinary efforto to acquire  •*mptome may be more Important, yet will
       and managerial
             ^*^ 4 Va «^
             etfcT li an .

 ^flB*«rMBon>'BUIIirU
 moat officer* and iinvmiewj *f
               that "kaoem" taformatiea
            InformaUOB which a prudeat i          	.	
      •BBitady attuated could reaaonably be ex-    cowmient tte Sam are reporuble dau die-
P»   •****•**• teaw- NegUgeace or IntenUoaal  t1rr.t.K^i  (m,  routine test*  including

  ~         of bto Metioa del obUgafirm  Part    Jiupoeje Thla  policy etaument dlreeta
                    Bdlfled to expreai the** b>  the repertiag of *pecifled effect* when un-
       	                          _^     kaowa to the Administrator. Many routine
       Gimme*! fcarcnmctaacc* can cxtot whoa  teata are baaed on a kaowiedc* of loxicny
              tote pceeeotton" of flat mforma.  tmoctatod wtth a rtinnlr*! unknown eft ecu
      	not eorreapond to an underetand-  aoeurrlag durmg cuch a nag* teat a»y have
      lag of the ftnpllratlon of the mformatloa:  to bo reported U they are theee of concern
      	   *" ahould be defined In term* of pee-  to UM Ageacy aad U the Information meeu
            of mformauoa and awamem of U*  the criteria art forth la Part* V and vt
                                                CHaimeaf Iti The meet  wMeapread ~m
       	The -obtaining* of Informattoa  turn" wgt to the Amea tact, which ti suemt
      occur* via  penon who *re -capable of ap-  to rnult"-1"* debate. Clarify the nrcuoi.
      piatiniiii  the itxnlflcanee of pertinent uv  itmcio under which pealUve reculu of  m
      formation."  There will likely be drcum»  rttro teat* muat be reported.
             IB which the evaluation of Informa-    juepoaer Part  VI elartflea thai the re-
           darUle* Ita full Import: the eet«bU*n-  poruag of  m vitro testa will drpmd upon
      	of corporate procedure* for precmlng  the niinenre of oorroboraUve Information
      rtak-taiformaUoa procribed la Part It will  tf aeeeaaary to reaeonably auppoit ute con-
                                              duataaofnitetantlaliUk.
                                           CtewMnl I: fifteen calendar daya to tawf.   plcof tbo noed la ndeflae Part Vsi •
                                          fldeat to determine whether information   ronmcaial Iff ecu" >.  Feralatenee »d  s. r n-
            reaponaiblo for reporuag inlor-   modave normal proceduni ume eonatrainu   cant expoaure.


                                         uoorat vm.«, MO n-rMuisoAT.MAtmie.ifH



                                                           Sc
-------
                                                         NOT1CIS                                                   UI15

   Aopoiue- Put V new clarifies Uiose ef-    AMPOIIM:  EPA  is coordinating this pro-     Comment 21- Clarify whether UIM. ».
 fecu for which reporting depends upon  a  (ram with other  aceneln no*. When into   qulrenenu apply to chemicals
 significant exposure potential. Persistence  eoerdlnatlon U successfully completed. Uit   but no lon«e7^Strt
 by Itself to no-longer Itemised ess report,  policy statement will be amended to exempt   dtotrlbuteo^eemmerce
 awe effect but ratlwr to considered to be  a  from the repenint requirement Information     ItepoMV  Information  obtained  hef<-M
 component of exposure potential: It mar  that ha* been eubmltud to other specified   WTI mutt bo  reported if Ottoman iH
 aleo underlie UM meamremenu described in  sgenctes. In  UM meantime, substantial-risk   beea awaro of It stnee
 Part VibMll. Laboratory IndicaMr. of pro.  information  muat be  reported  directly to   preeerlbed by^Part \^
 nouneed btaaoeumulaUoa are to be reported  CPA; such a report does net discharge any   cato which "perm has dtamuamd
 when coupled with poienUal for widespread  reporUng obligation to other agencies,        facturtng.
    	 IT: The n-octanel/water parti*    r. anosjfATXoji nrnsr accent* rmion TO ta    before the)
 __ coefficient addresses a physlea-cheml*             SFroctrvx DAT* or tec*             M Q^,, nqummmM. it to expected that
 eal property, not nioloiljDii ejects, andjs     cbmment Ur The tense of the verb -ob*   the *«cjutolHon  of  taformaUon after that
                      of substantial risk:   uinr* reveato that socUoa Kei was tateadsd   «mo will be minimal: however, should add}*
                                          to be applied prospoctivoly to  Information   tlonal taformaUon be acquired. It may trig.
                                          newly acquired after January 1.19TT. OUltoe   ttr the reporting described In Pan vuz
                                          section «d) or other rules to acquire tafor*     Comment Mr Clarify the meaning of "sub*
                                          matlon obtained before then.                 staatlal risk" relative  to other risks ad*
                                            JUrponser As dtenisssd ta the  preamble to   dressed by TBCA.
                                          Uu^Beptember 9 proposal, (he Agency emv.    JTsipoenv A substantial risk to defined ta

                                                              known to a person   of considerable concern bemuse of (a) the
                                                            ' January L ItTT. COB*   seriousness of the effect, sad  the fact or
                                          cemlng Information first obtained before   probability of Its occurrence. As opposed to
              	_, „._ _, _ „__   19H- thto policy statement eontiauea ta re*   other risks nrtaremmi by TBCA. economic or
 col bo reported to too bread and contradicts   mUr> '•Parting of Information received If a   social benefits of use. or costs of restricting
      ••»-—•• ".^.ST".*"-wtmftBlf   twrsaa has been aware of It since January L   use. are not to be considered In determining
                                   -~«   jm |gr ^ rcasoaa dianueoa  ta the Sea*   whether a risk is "suastanuai*.

    	The Agency hss provided ta a   t^2r*f!**m,b.ft.. ..—  .._.»- .. .^   ^Sf^. J*,TJLwhu tlt*n* •*• "•"•«•"
     Part VI Its tateraretauen of T»sson     Osmment IK The term  •aware*' to too   of rhsmlrels subject to  these requirements?
           rtV\  """-"      " ^*""m*   vague to be of any help ta responding to     Jtespo*usr The  Agency considers  that
       —' It: A determination that tafor*   Uw*t  requlremenu. Bines many  corporate   many tadastrtal uses of chemicals actually
        "reasonably supports  the concra*   ««woyees  are  potentially subject to these   fall within the scope of "processing" eheml*
               —   - -      T; BO ••*• m*   requirements, and  given uncertainty over   cato. A manufacturer, pnn lum or dlstribu.
                     ,.— of uMstaee   ^«tentM which they ought  to bo aware   tor who obtains substsaUaMtainfoimatioa
 	rTTusIng a chemicsl   °* Pre-MTT taformaUon. thto provision tends   «•«—*n-g chemicals he hsMles ihouw be
 may '-»»"-*»»» the occurrence of  an effect:   *° compel the very file search It was Intend'    alert to the  possibility he  may  have  to
 ta particular, the criteria should reflect a   ??J!?..M!ffS'nZ?l^J?f!^-">**f!" *B?u>d- •*   "ffflJ^
           between normal and  abnormal   £"*h"Ld"nB»* pa-****' ta terms of actual     Comment U- Are
    ^wuTTrWpe.n.^*il^^         ^&S£S^^AK^SSK  ^^^J^^^1'^^
    nsnses ef the effect, and      Comment Mr CPA should automatically  example, product research and development
scribed ta Parts 7  and (el Involve a sic*   publish section Me) notices.                 and studies  ni irininu  the  feasibility  and
alflcant exposure or exposure potential.         Aetpmse to Comments  M  Mien* M-  safety of using chemicals) preceding his or a
  The Agency further coattden that a deft-   CPA has Included a new Part  Z which do*  client's commercial use of such materials or
alUOB  of -normal"  use for  a particular   scribes bow to submit a dalm of eenfldea*  others on a larger scale.
chemical will often depend upon a  kaowi*   tlallty and states that any or all of the In-    As described la Pan V. the Agency connd-
edge  of  the  risks  tsiodstsd  with  the   formation submitted may be datmed as can*  ers that "substantial risks" depend in  part
                                          fldentlal. Such Information will be disclosed  upon aa exposure potential. Thus, the oc-
                                          by CPA only to the extent, and by means of  currence of the effects described In Part
                                          the procedures, set forth ta 40 CPB Part 8.  vca> Brssumiues exposure to the chemical
           Mr Information published ta       '       . MiecmuMwami               •^ att(t  •* '•Ported:  reporting  of  the
•etsntUta literature ta languages other than      •                    """"               other effects win depend upon  a potential
Cngltth should be exempted If published ta     Comment tK What to the statutory basis  for significant levels of exposure.
summary form by abstracting services. Can   or need for  guidance? What  to  Its exact    Comment Mr Are raw maurtals. interne-
the accuracy of Cngltob language abstracts   natus under the Administrative Procedure  dtates. and inert  Ingredients produced or
and commercial translations of  foreign lit*   Act?                        -             otM m the manufacture of s pesticide  tub-
erature be assumed?                          RerpoiuerThto policy statement sets forth  JectioTBCA?
  KUPWUK This policy statement now pro*   CPA's Interpreuuon of and policy concern.    JletponsK The  Administrator coruioen
vtdes that InformaUon published In oaen*   Ing TBCA  section We). As an interpretive  that raw materials. Intermediates and --«.-t
title literature, whether ta Cagltoh  or an-   rule and statement of policy It to not subject  Ingredients produced or used in the rr»nu.
other language, to exempt from reporting If   to the comment  period and delayed effee*  factiire of a pesticide are subttanea or  - i
published ta  summary form  by  certain   tlve date provisions of the Administrative  turea which can be regulated under TSC \.
specified abstract services.                   Procedure  Act  (S O.S.C.  551K.  Although    In order to be considered a peiur -- •
  Comment U: Information exchange sy»   TSCA does not mandate a policy statement,  substance mutt be Intended for use u . ^v
terns with other Federal agencies should be   the Agency of necessity must develop the  Udde. Raw  materials. intermedu:n  L- j
immediately established so that respondents   criteria which wui govern  enforcement ae-  inert ingredients produced or used  -
aesd not report to CPA information already   virtues. Trade associations and businesses  manufacture of  a pesticide are  noi
reported to other Agencies, and vice vena,   were among those who previously expressed  selves regulated under PIFRA  •*  .
	                                     compliance.                               therefore,  are subject to TSCA.  T-*  -


                                 nOflM StOUTM. VOL 43. NO. »-THUI$OAV. MAICM 14, If7»



                                                             97
-------
lint                                      Nonas

                efcte Kfulatlona at 40 cm 1*14 v* egad*  production of a food, food addnrw.
                tent with thU view.                  oooMtfe. or device,
                 Ommm jr Art Intermediate and eat*    cbwMiti M* taployeaa ihouM have UM
                lyeia Intended Mlely for uat la the produo*  option to fubnlt report* aaonjrnoutUr.
                tlon of a food, food additive, drag, oaoMUe,    Jtopoiur XPA eetmatra uut HUT ptnoa
                erdtTtotwbXettoTSCAr             auy npon lafonauoa to IPA under
                 ItMfnmm.-  TH* AdmlnJMntor eoatidm  T8CA, TTiooi who ir> roqulrtd to do «o

                                                                  In
                                                                  INK
                                                          cntlUoi but atao nteh i
                                                            In Put n. In order to
                                                         , and to order to i
                                                     »review of the quality of I
                                                  Bd **** lubctanUattty of rtofea, IVA bo*
                                                   that notlflen should Identify thenv
                 lcataly«atobeMeheoBpancBU.Th*re>  calvoa, Bonion a will adequately protect
               fora, they are eaMect to rmiUiion ander  tmnlnrtoi from iHommlnailnn pnmiant to

                              • T8CA tauofar ai It to
                                  MHMd, or dto>
                                   for not to the
                According to.rtachnical  amendments  published
                by EPA  in  the May  29,  1987  FEDERAL" REGISTER
                 (52  FR  20083),  TSCA  Section  8(e)  submissions
                are  to be addressed  to the  Agency as follows:

                       Document Processing  Center  (TS-790)
                       (Attn:  Section  8(e)  Coordinator)
                       Office  of Toxic Substances
                       U.S. Environmental  Protection  Agency
                       401  "M" Street, S.W.
                       Washington,  D.C.  20460
                              •MISin. VOL O. MO. »-THUUOAY. MAICN I*. Iff*


                                          98
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Friday,
February 1, 1991
APPENDIX D

(CAP Notice)
Part II


Environmental

Protection, Agency

Registration and Agreement for TSCA
Section 8(e) Compliance Audit Program;
Notice
  99
-------
4128
Federal Register ' Vol. 56. No. 22  /  Friday. February 1. 1991 / Notices
ENVIRONMENTAL PROTECTION
AwErfCY

(00TS-4001S; mt-3844-4)

Rootatratfon Mid Aejroemeitt for TSCA
Section 8(0) CornpHanco Audt
      « Environmental Protection
Agency (EPA).
       : Notice.
«     urn This Notice, pursuant to---
sections IS end 16 of the Toxic
Substances Control Act (TSCA). 13
U.S.C 2801 tt see., eaaeimcee the
oppoztBDity to register for EPA't TSCA
Section 8(e) Compliance Audit Program
This Notice el to cooteins the text of en
Agreement for the TSCA Section 8(e)
Compliance Audit Program ("CAP
Agreement1*]. The TSCA Section 8(e)
C
program ia based on sound guidance
                                                     100
-------
                   reoarai Register /  vol. 56. No. 22   -naay. t-eoruary  1. 1991  /  Notices
                                                                     4129
•.hat is and has been consistent with the
itatutory language and intent of section
)(e). aa well aa EPA'a Section 8(e) Policy
Statement Nevertheless, toicnieve the
Agency's goal of obtaining any
	-inding section 8(0) *•«•» EPA has
     oped this one-time voluntary
     liarc* program designed to
	jly encourage companies to
/oluntarily audit **«•*• files for studies
••portable under section 8(e). Thia
irogram is known aa the TSCA Section
i(e) Compliance Audit Program.
 The TSCA Section 8(e) Camnlta
\udit Program has been developed to
•ncpurage industry reporting by setting
orth guidelines that identify in adv	
iPA's enforcement response and allow
:ompaniea to assess liability prior to
•lecting to participate. Companies that
lo not participate m the TSCA Section
•(a) Ccxplianca Audit Program should
ie aware that EPA intends to actively
lurtue inaUrian* of «lv» TSCA section
.(e) reporting requirement

L Text of the Regtetanao/CAP
 The text of the Registration end CAP
Agreement for the TSCA Section 8(e)
lomplience Audit Program:
JNTTED STATES ENVIBONMENTAL
'ROTECTION AGENCY
egittntion oad Agnmtnt for TSCA
action tf») Compliance Audit Program
 The United States Environmental
•roteetion Agency ("EPA"1 and the
     itee. the Parties herein, wishing to
     ir for and enter into this
     nent for a Toxic Substances
.-..- ol Act (TSCA") Section 8(e)
:ompliance Audit Program ("CAP
tgreemenf*) and having consented to
ie terms of this CAP Agreement do
lerefore agree to fully comply with the
anas of this CAP Agreement

 togiattadonRauiili.iiiei.la
 A. The Regulatee agrees to conduct • -
SCA Section 8(e) Compliance Audit   -
Togram to determine its compliance
tatus with TSCA section Sfe).
 B. To register for the TSCA Section
(e) Compliance Audit Program, the
egulatee mutt no later than May 2.
391. sign and return this CAP
greement by certified mail-return
iceipt requested to: Michael F. Wood.
(rector. Compliance Division (EN-342).
'ffice of Compliance Monitoring.
nvironmental Protection Agency. 401M
t.. SW.. Washington. DC 20480.
 C. After EPA receives this signed CAP
greement from the Regulatee. EPA will
gn tnis CAP Agreement and enter the
>llowmg identification number
	) to the copy of
 this CAP Agreement which will be
 returned to the Regulatee. The Final
 Report and all other documents
 submitted pursuant to Unit O.C of this
 CAP Agreement must display the
 identification number established by
 this paragraph.
  D. The TSCA Section 8(e) Compliance
 Audit Pn'ip"'" «h«n Mnmii«flCT no liter
 than May 2. 1991.
  E. The TSCA Section 8(e) Compliance
 Audit Program shall terminate within
 ISO days of May 2. 1991. Thus, all

 8(e) Compliance Audit Program most be
 delivered to EPA no later than October
 28.1991.


  EPA and the Regulatee mutually
 initiated this TSCA Section 8(e)
 Compliance Audit Program in response
 to a February 1. 1991. Federal Register
 notice unoundag the opportunity to
 participate in the TSCA Section 8(e)
 Compliance Audit Program. Aa part of
 this CAP Agreement EPA and the
 Regulates agree to the following:
A. Genera/ Proviiiotu
  1. Thia CAP Agreement and the
Consent Agreement and Consent Order
 in this matter shall be a complete
 settlement of all civil •****
claims and causes of action which arose
or could have arisen under TSCA
section 8(e) in connection with any  -
study or report submitted pursuant to  •
the terms of this CAP Agreement   •
Pursuant to TSCA. EPA will consider
ability to pay/effect on ability to

the course of development of the
Consent Agreement and Consent Order-
in this matter. The Regulatee will be
responsible for submitting adequate ...
documentation of such claims to EPA at
the **"** of submission of the Final
Report required by this CAP Agreement
  2. For purposes of this CAP
Agreement M>vt any subsequent
pioceeding. without trial or any
adjudication of the facts, the Regulate*
admits that EPA has jurisdiction over '
the subject matter of the terms of this
CAP Agreement and any study or report'
submitted pursuant  to ****• CAP
  3. The Regulatee waives its right to
request a judicial or administrative
hearing on any issue of law or fact that
has arisen or may arise during the
conduct of the TSCA Section 8(e)
f^mfiHmttf^ Audit Program conducted
pursuant to the terms of this CAP
Agreement or that may arise in any
subsequent proceeding involving the
Consent Agreement end Consent Order
resulting from and entered into pursuant
 to the terms of this CAP Agreement
 including but not limited to the
 Regulatee's right under TSCA section
 18(a)(2)(A) to request a hearing.
   4. The Parties agree that any study or
 report submitted by the Regulatee under
 this TSCA Section B(e) Compliance
 Audit Program and pursuant to the
 terms of this CAP Agreement constitute
 e violation of TSCA sections B(e) and
 15(3)(B). for which a civil penalty will be
 aasessed against the Regulatee. Any
 study OE report submitted under TSCA
 section 8(ej prior to the date of
 commencement of the TSCA Section
 8(e) Compliance Audit Program is not
 subject to the terms of this CAP
 Agreement; or the TSCA Section 8(e)
 Compliance Audit Program.
   S. EPA reserves its rights under TSCA
 section 18 to take appropriate
 enforcement action if EPA determines
 later that the Regulate* was rvquind to
 submit under TSCA section o(e j e study
 or report determined by the Regulatee to
 be not reportable and therefore not
 submitted under the TSCA Section 8(e)
 Compliance Audit Program. In such
 event the terms of the EPA TSCA
 Sections 8,12. •"*< 13 Enforcement
 Response Policy will apply to such
• proceeflingi
   8, EPA reserves its rights to challenge
 the categorization of studies or reports
 submitted under this TSCA Section 8(e)
 Compliance Audit Program pursuant to
, the requirements of Unit ILE24 and b of
 this CAP Agreement   *_ . .
   7. EPA agrees that any submissions
 m««fa pursuant to the terms of ***** CAP
 Agreement and the TSCA Section 8(e)
 Compliance Audit Program will be
 viewed by EPA es "prior such
 violations" under TSCA section
 l8(aU2)(B) for future violations of TSCA
 section 8(e) only.
   8, The Final Report submitted
 pursuant to Unit ILC.4 of this CAP
 Agreement shall be the controlling
 docnment for purposes of determining
: what was submitted under the TSCA
 Section 8(e) Compliance Audit Program
 •nd ***** CAP Agreement
   8. Any submission made by the
 Regulatee to EPA that does not meet all
 of the requirements of the TSCA Section
 8(e) Compliance Audit Program and this
 CAP Agreement is subject to the EPA
 TSCA Sections 8.12. and 13
 Enforcement Response Policy.
 A TSCA Section 8fef Compliance Audit
 Program and Civil Penattiet
   1. In conducting the TSCA Section 8(e)
 Compliance Audit Puny*™, the
 Regulatee shall use EPA's March 16.
 1978. "Statement of Interpretation and
 Enforcement Policy. Notification of
                                                         101
-------
 4130
                    Federal Register / Vol. 56. No. 22 / Friday. p-hniary l.  1991 / Notices
 Substantial Risk" (43 FR 11110) ("TSCA
 Section 8(e) Policy Sutement"ito -
 detennine %vfaather the ravitwed itudy
 or report Is:
   a. Not npwtab/e undo- TSCA Section
 8(e)i Tha Ragulatee will not submit the
 study or report      _
   b. Reportoble tinder TSCA Section
 sfe): Tha Regulatee will submit the study
                         _
   Upon Registration far the TSCA
 Section 8(e) Compliance Audit Program.
 the Regulatee will receive • copy of the
 TSCA Section 8(e} Policy Statement, the
 publication numbers of publicly
 available and previously published
 volumes of Section 8(e) "Status Reports"
 available through the National
 Technical Information Service, copies of
 Question and Answer documents
 developed la response to specific
  Suestioas involving section 8(e). and e
  ocument entitled "Substantiating
  2. The Regulate* agrees to pay the
 following stipulated civil penalties for
 all studies or reports submitted under
 this TSCA Section 8(e) Compliance
 Audit Program as TSCA section 8(e)
 data:
  a. Sl&OOO per study for any submitted
 study or report involving effects in

  b. MiOTft per study for any other
 submitted study or report submitted as
 TSCA section 8(e) data.
  As a matter of policy under this TSCA
 Section 8(e) Compliance Audit Program.
           B a SLOO
EPA agrees to s!
cap on the
total civil penalty for the Regulat _
  3. The Regulatee shall be exempt from
any additional late and/or nonreporting
TSCA section 8(e) civil liability which
arose or could have arisen for any study
or report submitted under this TSCA
Section 8(e) Compliance Audit Program.
  4. Upon termination of the TSCA
Section 8(e) Compliance Audit Program.
the Regulatee shall provide EPA with a
Final Report certifying that the TSCA
Section 8(e) Compliance Audit Prognm
has been completed Such Final Report
shall be signed and certified by the
appropriate corporate official with
authority to settle elaima on behalf of
the Regulatee. Such Final Report shall
also comply with the requirements of
Unit n.C.4 of this CAP Agreement
  5. Following termination of the audit.
EPA will present the Regulatee with •
Consent Agreement and Consent Order
summariflng the results of the TSCA
Section B(e) Compliance Audit Prognm
and specifying the terms of payment of
stipulated civil penalties. The Regulatee
will have 30 calendar days from its
receipt of an executed copy of the
Consent Order to pay any stipulated
civil penalties.
               C Information Subtunion and Final
               Report
                 1. All studies or reports submitted to
               EPA by the Regulatee under the terms of
               this CAP Agreement shall be identified
               pursuant to the categories established in
               Unit ILEZa and b of this CAP
                     ent. '"4 «h«n be sent to the
                                      Agreeme
                                      following
                      J address: Document Processing
               Canter (TS-790). Office of Toxic
               Substances. Environmental Protection
               Agency. 401M St. SW, Washington. DC
               20400. Attw SectioadsXe) Coordinator
               (CAP Agreement).
                 2. The Regulatee shall submit one
               original and two full copies of all cover
               letters, studies, reports, substantiations

               appropriate, sanitised copies of cover
               letters, studies, reports, or
               substantiations of confidentiality claims.
                 3. !n acsordeaee with Part DC of th*
               TSCA Section 8(0) Policy Statement
               each study or report submitted to EPA
               by the Regulatee under the terms of this
               CAP Agreement shall be smwiBP^nied
               by a separate cover letter containing the
               following information:
                 a. Company ••••, address fT*c
               telephone number.
                 b. The signature and printed name.
               title and telephone number of the person
submitting the study or report.
  & A clear statement that the
document identified on the cover letter
by the Htnttflcitien number established
by Unit LC of this CAP Agreement is
being submitted pursuant to the TSCA
Section 8(e) Compliance Audit Program
and this CAP Agreement
  d. The exact identity of each tested
chemical or mixture or component of e
tested mixture including the CAS
Registry Number, if known.
  e. The Hue of the accompanying study
or report
  f. A full summary of the reportable
adverse effects) or exposurafs)
observed in the accompanying study or
report In addition, the cover letter
should identify by EPA Document
Control Number any previous TSCA
                                            18(e) submission(s) or
                                      premanufacture notiflcation(s) (PMN{s)J
                                      submitted by the Regulatee on the
                                      subfect chemical substance(s) or
                                      mixture or components) of such
                                      mixture.
                                        4. Each study or report submitted to
                                      EPA by the Regulatee under the terms of
                                      this CAP Agreement shall be listed in e
                                      Final Report Such Final Report shall list
                                      each submitted study or report by title
                                      pursuant to the categories established In
                                      Unit IL&£a and b of this CAP
                                      Agreement and shall display the
                                      identification number established by
                                      Unit LC of this CAP Agreement. Such
                                      Final Report shall certify that the TSCA
                                      Section 8(e) Compliance Audit-has been
                                      completed and include the following
                                      statement "I certify that the information
                                      contained in or accompanying this Final
                                      Report is true, accurate, and complete.
                                      As to any Identified portionfs) of this
                                      Final Report for which I cannot
                                      personally verify its truth and accuracy.
                                      I certify aa the company official having
                                            '  iry responsibility for the
p6fvoii(§j woo* Acting under oy dinct
instructions, nude the verification, that
this information is true, accurate, and
complete." The Final Report will be the
controlling document as to what was or
was not submitted under the terms of
this CAP Agreement and shall be sent to
the address specified in Unit LB of this
CAP Agreement
D. Other Matte*
  1. Nothing in this CAP Agreement
shall relieve the Regulatee from
complying with all applicable TSCA
regulations or other applicable
environmental statutes.
  2. This CAP Agreement shell be
binding upon the Parties and in full
affect pursuant to the requirements
specified in Unit Lot this CAP
Agreement.
  3. The Ragnlatee's obligations under
this CAP Agreement shall end when the
Final Report required by Unit O.C.4 of
this CAP Agreement has been submitted
to EPA and stipulated civil penalties
paid..
  4. Failure to comply with the terms of
this CAP Agreement permits EPA to
proceed TOniitr TSCA section 16 to
impose the civil penalties allowable
under the existing EPA TSCA Sections
B. 12. and 13 Enforcement Response
Policy for any study or report submitted
pursuant to Unit HC of this CAP
                                                                                                id conditions of
                                                       5. All of the ti
                                                                            this CAP Agreement
                                                                                        it and
                                                         	                of the terms
                                                     and condltfone la in consideration for all
                                                     of the other terms and conditions. In the
                                                     event that this CAP Agreement (or one
                                                     or more of its terms and conditions) is
                                                     held invalid, or is not executed by all of
                                                     the signatory parties in identical form.
                                                     then the entire CAP Agreement shall be
                                                     •nil and void.
                                                       6. The Regnlatee may assert claims of
                                                     confidentiality under TSCA section 14
                                                     for submissions under this CAP
                                                     Agreement The Regulatee must at the
                                                     tlIU0 Os mbOlMlOAs aWOVldiJ
                                                     substantiation for all Information
                                                     claimed as confidential. The Regulatee
                                                     agrees that the failure to assert e claim
                                                     of confidentiality for studies, reports, or
                                                     information submitted under the terms
                                                     102
-------
 of thu CAP Agreement shall be
 interpreted by EPA as • waiver by the
 Kegola.ee of the right to aatert a claim
 of confidentiality.
  7. Submiiiiona "•"<•<"'"[ information
 -'-'Tied aa TSCA Confidential Business
    rotation (TSCA GUI) shall contain
    T sheets bearing the typed or
    iped legend "company confidential."
 "proprietary/  or "trade* secret*
 Information contained in the snbnission
 which is claimed as TSCA CO moat be
 dearly marked by boxing, circling, or
 underlining the specific text to claimed.
 All pagee containing such information
 shall also be marked
 "CONFIDENTIAL." Can should be
 taken to ensure that these HHt^r'ng* do
 not obscure the text of the submission.
 Submissions directed to EPA in this
 manner should be sent by certified mail*
 return receipt requested or in any other
 way which will permit verification by
 &e RetfulatM oi' its receipt by EPA.
  8. If the Regulatee chooses to assert a
 confidentiality claim, the Regulatee shall
 provide two seta of each such
 submission: one set shall have the TSCA
 f^Bt material marked in the HM******
 contemplated under 40 CFR U03(b) and
 Unit ILD.7 of thia CAP Agreement the
 second set shall have the TSCA CBI
 material excised. The Regulatee ia
 advised that the second, "sanitiied" set
 will be available for public review
 without further notice to the Regulate*
 and therefore care should be exercised
 in the creation of this set  Each sanitized
-=-A unsanitlzed submission must
     ly with Unit O.C2 of this CAP
Agreement and thus will consist of one
original and two copies.
  9. The Regulatee ia advised to review
carefully the confidentiality claim
procedures at 40 CFR £201. Specific
information concerning TSCA section
8(e) confidentiality claims ia contained
at Put X of the TSCA Section 8(e)
Policy Statement
  10. The Regulatee agrees that if the
specific chemical identity ia claimed aa
confidential in a submission a generic
tM«i.-«iifiHftntiet rh"t"*"'<«'»I Substance Inventory;
1985 Edition, or by contacting the Office
of Toxic Substances' Chemical
Inventory Section at (202) 383-3527.
  11. The Regulatee agrees that
confidentiality claims will be honored
by EPA only if each claim ia
accompanied by responses to the
questions in the document provided with
this CAP Agreement entitled
"Substantiating Claims of
Confidentiality." The Regulatee shall
provide an original and two copies of
these responses in accordance with Unit
U.C2 of this CAP Agreement The
Regulate* shall also, in the event the
Regulatee desires information in these
responses to be considered TSCA CBL
provide a sanitized original and two
copies ia accordance with Unit O.C2
and Unit ILDJ of this CAP Agreement
  12. The Regulatee agrees that failure
to adhere to each requirement pertaining
to TSCA CBI may result in forfeiture of
the CBI protection for the submission
and its subsequent availability in its
entirety for public review.
WE AGREE TO THIS:
For Regulatee:

[StgoJasofBdaq
/TO/./
[Company name]
[Tito)
(Company name]

For EPA:
Michael F. Wood.
Director. Compliance Divwon. Office of
Compliant* Monitoring.
tit Cciuae
Auaaatf Snfei
andTauc Substance*.

m Conclusione
  EPA has announced the opportunity to
register for the TSCA Section 8(e)
Compliance Audit Program. Any further
information regarding this Audit
Program or the CAP Agreement may be
obtained from the contact person noted
above.
  Dated: January 23. U0L
Linda). Fisher.
Assistant Administrator for Pesticides and
Toxic Substance*.
(FR Doc 01-3299 Filed 1-31-01:8:45 am|
                                                          103
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     Friday
     April 26, 1991
   APPENDIX D

(CAP Modifications)
     Part VI



     Environmental

     Protection Agency

     Registration and Agreement for TSCA
     Section 8
-------
 19514
Federal Register / VoL 56. Na 81  / Friday.  April 28. 1991  / Notices
 ENVDMNMENTAL PROTECTION
 AGENCY

 (OPTM001M; BflL-atei-oJ
  •ettanM)Cemp«ane«Audtt
       : Environmental Protection
Agency (EPA).
       » Notice.
        r This Notice, pursuant to
sections 15 and 10 of the Toxic
Substances Control Act (TSCA). 15
U.S>C. 2601 et seo>. •«*"«••*••
nodfiesaentte.EPA's TSCA Section
B(e) Compliance'Audit Program and the
Agreement far the TSCA Section 8(e)
Compliance Audit Program ("CAP
Agreement"). The modifications to the
TSCA Section 8(e) Compliance Audit
rrsgraa sad the CAP Agreement
include extension of the registration and
termination dame, the opportunity to
petition EPA lor e case-by-case
extension of the termination date.
modifications to>the CAP Agreement
provisions regarding edmission of e
violation of TSCA section 8(e) and
waiver of right «je hearing, and EPA's  •
development of a TSCA section 8(e)
reporting guide.'   ==-
OATBK The RegHtretion period for me
TSCA Section 6(0) Compliance Audit .- r
Program doceeon June 18, im. Persona
interested in registering lor the TSCA
"action 8(e) Compliance Audit Program
 lust request a CAP Agreement and
 iibmit a signed CAP Agreement to EPA
 o later then June 18.1991.
Aommnene: Copies of the CAP
Agreement may be obtained from tite
TSCA Assistance Information Service.
Environmental Assistance Division (TS-
The TSCA Section 8(e) Compliance
Audit Program hoe been Initiated to
foster compliance with the statutory
obligations of TSCA section 6(e). and to
obtain critical information about
potential risks of chemical substances.
la designing the TSCA Section 8(e)
Compliance Audit Program EPA'a
objective was to provide, in the context
of an enforcement initiative. PoaWen
incentives for companies to conduct
audits of their data and to submit to mo
Agency the type of information required
under section 8(e) of TSCA.
  EPA recognizes that proper
application of eectioa 6(e) requires the
exercise of scientific Judgement EPA a*
not interested la cresting an atnsBsnhere
in which companies view a "data dump*
strategy as the best course of action for
                                      hopes<
                           eooperati1
                                      among EPA. data submitters, and other
                                      interested parties can leed toei
                                      successful TSCA Section 8(e)
                                      Compliance Audit Program and
                                      ultimately a better understanding of the
                                      section 8(e) program. Based on written
                                      communications with die regulated
                                      industry. EPA has made the following
                                      modifications to the TSCA Section ate)
                                      Compliance Aadtt Program and CAP
                                      Agreement nut was published on  _
                                      February 1.1981.          j*
                                      IL Modifications to the TSCA
799). OfBce of Toxic Substax
Environmental Protection Agency. 401M
SU SW, Washington. DC 20480. (202)
554-1404. TDD: (202) 594-0581.
                                      CAP
                                      A. JUgutmtioa Acquirements
                                        The registration deadline/audit
                                      >«MiiMflffmftm date has been extended
                                      for 4ft days to lone. 18.1991. Thus. Unite -
                                      LB and D of the CAP Agreement henre
                                      been modified to read as follows:
                                        & To reneter tar me TSCA Section etc)
David Kling,Acting Director.
Environmental Assistance Division (TS»
799). Office of Toxic Substances.
Environmental Protection Agency. 401M
SU SW, Washington. DC 20490. (202)
554-1404. TDD: (202) 554-0581.
  In the Federal Register of February 1.
1991 (58 PR 4128). EPA announced the
opportunity to register for the TSCA
Section 8(e) Compliance Aadit Program.
The TSCA Section 8(e) Compliance
Audit Program is a one-time voluntary
compliance audit program developed in
order to achieve EPA's goal of obtaining
any outstanding TSCA section 8(e) data.
                                          , no later lime la. 199L sign and i
                                      th» CAP Agreement by certified i  "

                                        ttThe TSCA Section He) CempBenes
                                      Audit r                          '
                                      JOBS mum.
                                        The audit termination date/deedHne
                                      has been extended for approximately 60
                                      days, to February 28.1992. Pi in miniee
                                      for case- by-case extensions have also
                                      been added. A Regulatee can petition
                                      EPA in writing no later than November
                                      29.1981. for an additional extension of
                                      the audit termination date (Le~ beyond
                                      February 28.1992). Extension petitions
                                      must contain aa adequate Justification
                                      for die request and will be favorably
                                      viewed If based on difficulties
                                      experienced by e Regulatee with the
                                      volume of information being reviewed
                                      and not because the Regulatee delayed
                                      initiation of the audit Companies are
                                                       urged to submit studies or reports ss
                                                       they an determined to be reportable.
                                                       and extension petitions will be viewed
                                                       with disfavor if e Regulatee has not
                                                       eefamitted any Information by the
                                                       November 29.1991. deadline for
                                                       extension requests. In this wsy EPA
                                                       encourages the phased receipt of
                                                       Information over time while recognizing
                                                       the need for appropriate time extensions
                                                       far Regelatees that have e lane amount
                                                       of records to review. Thus. Unit LE of
                                                       the CAP Agreement has been modified
                                                       to reed as follows:
                                                         E The TSCA Section sfa) Complii
Audit Program shall terminate on February
A19B, and all submissions under this
      aeuon S(e) Compliance Audit
   .._! must be delivered to EPA no later
	i February Zs. UK. The Regulatee may
petition EPA la writing at the address
spasmed m Unit LB of this CAP Agreement
toon extension of the February 28.1982.
uueiliiillmi date. Extension requests must be
received by EPA no later than November 29.
UBt and must contain SB adequate
(esOficstfoa lor the extension.

  No other modifications to the
"registration requirements" portion of
the) CAP Agreement have been made.

B. rents of Agreement-General
                                                         The provision of the CAP Agreement
                                                                                  ation or a
                                     ~ Vlflilfduaml oUI tOflUafS1O& OS VIOi
                                     ' "violation of TSCA' has been changed
                                      and Untt UA.4 of the CAP Agreement
                                      nee been modified to read es follows:
                                        4. The Regulatee neither admits nor denies
                                      met the submission of studies or reports by
                                      me Regulatee under this TSCA Section 8(e)
                                      Compliance Aadit Program sad pursuant to
                                      the terms of mis CAP Agreement constitutes
                                      admission of a violation of TSCA sections
                                      ate) and ISPKB). but agrees to pay s
                                      ellisilaleil dvil penalty for each study or
                                      report m accordance with Unit II&2 of this
                                      CAP Agreement Any study or report
                                      selenllisil under TSCA section go) prior to
                                      mo date of coBues&csmsut of the i9CA
                                      Seottoa 8(e) Compliance Audit Program is not
                                            to the terms of this CAP Agreement or
                                      me TSCA Section do) Compliance Audit
                                                         The) provision of the CAP Agreement
                                                       lefjardms waiver of rights has been
                                                       changed and Unit ILAJ of the CAP
                                                       Agreement has been modified to read as
                                                       t-jt^...-,
                                                       lUUUWS.
                                                         X Ths Rseulatae waives its right to request
                                                       e Judicial or •dmiaisnttva heanag, under
                                                       TSCA section 16(a)(2)(A) or other provisions
                                                       of law. OB any Issus of Isw or fact that has
                                                       arlan or may arise regarding the application
                                                       of TSCA section 8(e) to any study or report
                                                       •ubmittad eonuant to Unit 03.1 of this CAP
                                                         The prevision of the CAP Agreement
                                                        "y»<'«g "prior violations" has been
                                                       105
-------
                      Federal Register / Vol. 56. No. 81  /  Friday.  April  28. 1991  / Notices
                                                                                                           19513
modified •lightly to nuke It clear that
submissions under the CAP Agreement
will count •• one "prior violation" of
8(e) only. Thus. Unit JLAJ of the CAP
Agreement has been modified to read as
follows:
  7. EPA aeree* that any evboiMioas made
                « of Una CAP ^
pursuant to lh« terms i
and the TSCA Section S(e| Compliance Aodit
Program will be viewed by EPA u eae "prior
•uch violation" under TSCA Medea
!6(aN2HB) lor town violations of "RCA
eection 8(0) only.

  No other modifications to the "term*
of agreement-general provisions"
 wrtien of the CAP Agreement hay*
 Men made.
C rente of Agnmmt-TSCA Section
Bfef Compliance Audit Program and
Civil Panellist
  In order to facilitate participation in
the TSCA Section 8fc) Compliance
Audit Program as weU as to improve
section 8(e) compliance in general EPA
is preparing and plane to disseminate a
section 8(e| reporting "guide" comprised
primarily of approximately 150 existing
TSCA section 8(e) submission "Status- -
Reports" which contain useful reporting
••if implementation guidance. This
guide will include two indices. The first
index, which pertains to the ISO "Statue
Reports," will be arranged by.
toxicologic study type and other- -   -
                     related to
reporting criteria. The second index will
be cumulative and arranged by typo of
study for all initial submissions received
n««jy> imiMfln B(e) to date. An additional
component of the guide will be •
consolidated presentation of section 8(e)
question and answer (QftA) documents  -
arranged under subheadings similar to  -.-
the indices described above.
  In response to a written request from
the Chemical Manufacturers
Association (CMA) for additional  -
guidance in the areas, 9j|neH»toxie._
effects and environmental effects/ .--"
releases. EPA agreed to perform an
expedited review of a limited number of
nase histories to be submitted by CMA
in early May. The Office of Pesticides
and Toxic Substances (OPTS) is
establishing a panel of EPA staff
scientists to perform the expedited
review of the case histories which are
submitted. While the EPA panel **••
address endpointe of concern. CMA was
asked to prioritize the submissions to
focus attention on the key scientific
questions, especially neurotoxicity/
ante tnddty concerns. The EPA review.
will focus  primarily on whether the
studies would be raportable under
section ate). The rationale for EPA's
on s specific schedule which will be
determined later based on when EPA
completes and disseminates the
guidance in ****• area.
  Thus, to reflect the availability of the
TSCA section 8(e) reporting guide, the
second portion of the CAP Agreement
language at Unit nai haa been
modified to read aa follows:
                                                       •PC
the appropriateness of reporting will be
provided as part of the section 8(e)
reporting guide which has been
described above. EPA will make every
effort to complete the guide in early lone
and release it prior to the revised fune
18.1691. registration deadline/audit
commencement date.
  EPA requested that the environmental
effects/release cases focus on areas that
Industry believes are problematic in
terms of what Is reportable under
section 8(0). In order for EPA to respond
men completely about the section ate)
reportabtlitv of the provided •'•=• ~~
environmental effects/relesse3*1*-   ~
Information cases. EPA also asked if the
information is required to be submitted'
to another governmental authority and;
if so, the Identity of that authority and*
the timeframe for the reporting; The
rationale for EPA's conclusion and

appropriateness of reporting will be
provided ae part of the section 8(0)
reporting guide described above. EPA"
will make every effort to complete the
guide la early lune and release it prior to
the revised June ia 1991. registration^1"
deadline/audit commencement date-
However, if necessary because of a
  -Upon R*gUtntton for the TSCA Section
8(e) CompUsnei Audit Program, the
Regulate* will receive a copy of the TSCA
Section ate) Policy Statement the pabUcstioa
numbers of pnbUdv svailaUo and piwiously
published volumas of Section ate) "Status
Reports" available through me National
Technical Information Service, copie* of
Qontion and Answer docamenu developed
In rsrponse to spedna quntions uwolv ng
•oction tM. a document entitled
"Substantiating Claims of Confidentiality."
ukd Bat TSCA MCttoD £(•) Kpoftfaigj guidA*

  EPA believes Out the actions
described above emphasize the ....
Agency'* strong »««"'»**»i»«»it to i
the TSCA Section 8(e) Compliance
Audit Program a successful initiative.
EPA hopes that providing the selected
case histories and the section ate)
reporting guide will enhance,
understanding of the TSCA section 8(e)
program and assist the regulated
community aa they participate in the
TSCA SaeMaa Afal Cannlianc* Audit
                                                                             TSCA Section*.}
                                                                             Program.
                                                                             m.
delay in completion of the guidance on~    Vlemt |. Mam
the environmental effects/release       '  Acting AMI***
information, reporting of this              aadTMeSuai
information under the TSCA Section 8(e) •
Compliance Audit Program will be pot
                           i Audit
                                                                               EPA haa announced modifications to
                                                                             the TSCA Section 8(e) Compliance
                                                                             Audit Program and the CAP Agreement
                                                                             Any further information regarding ih.i
                                                                             Audit Progranvor the CAP Agreemer:
                                                                             may bo obtained from the contact
                                                                             person noted above.
                                                                               Dated: April MUM.
                                                                             Victor |.
                                                                                   AssJttenl Adainittnterfof Pet •
                                                                             [FR Doc. n-ionaaFikd*-ae-«t 8:43.-
                                                   106
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   Thursday
   June 20, 1991

 (Encoded Version)
   APPENDIX D

(CAP Modifications)
   Part IV



   Environmental

   Protection  Agency

   Registration and Agreement for TSCA
   Section 8(e) Compliance Audit Program
   Modification; Notice
107
-------
ENVIRONMENTAL PROTECTION
AGENCY
[OPTS-40015B; FRU3932-1]

Registration and Agreement for TSCA
Section 8(0) Compllenee Audit
Program llodHlcetlon

ACmer; Environmental Pictection Agency
(EPA).
ACTON: Notice.
                                        section 8(e) data and foster compliance with
                                        dM itunoiy oUii   BBS of TSCA section
                                        8(e).
                                          Oa April 26,1991 (36 FR 19SI4X EPA
                                        modified te TSCA Section 8(e) Compliance
                                        Audit ftogram arid ihe CAP Agreement. The
                                        nndifications included extension of dw
enpfmim airly two weeks to July 1.1991.
Thus, Units LB aid D of dw CAP Agreement
have beat •«~«fH1 to reed u follows;
  B. To Kfuttr for the TSCA Section 8(e)
CamptincB Aada Proem, (be Reaalatee ana. no
totr th0 July 1.1991. oca nditmmtfaii CAP
        i by.
9    MY: This Notice, i
15 and 16 of the Tone Substances Coaool
           is u.s.c uoi « •»*.
    sBosedwevailamliiyofBwTSCA
«ectioa8(e) reporting guide <
0 EPA'a TSCA Section 8(e) Compliance
Audtt Program and dw Agreement for the
TSCA Section S(e) Compliance Audit
                                        opportunity to petition EPA for a case-by.
                                                    i of dw termination date,
                                                   i to dw CAP Agreement
                                                        , -l»i««i«m at m wt^Mfr^
                                        of TSCA aaction 8(a) end waiver of right to
                                               _, and EPA's development of a TSCA
                                              t8(e) reporting guide.
                                                                                1991.
                                                                                                  «e)Com9lUnce Audit
                                                                                                   oo liter An July 1.
                                                                                  No other "y'iiTv*'*""* to dw
                                                                                "Regis
                                                                                            Require
                        ' portion of the
Prog
compii
Agree
       rCAPAgreement"XThe
            ^ (he TSCA ^~*t~* 8(e)
            udu Pragma Mid the CAP
                                        H. TSCA gsctioe K«) JUporttot Guide
                                          Since tiw Aprfl 26.1991 modifications
                                                       f£f)A  i laiiilitiart
                                                       crA oompmm
                                                              section 8ioryreporung
obligation under TSCA or another EPA-
edmaostBrad statnta. or (2) received by OTS
on ea "FYT* basis and included in die formal
OTS "FYT* fifing system, prior to June 18.
1991. THs approach meets EPA's TSCA
Section 8(e) Compliance Audit Program goal
of obtettnf, m dw context of SB enforcement
                    coon 8(e)
          .mstaed of naubmtting copies of
dwse types of studies or reports, the
automation may simply be listed under the
TSCA Section 8Cs) Compliance Audit
Program end identified by cover lener. A
$3,000 stipulated dril penalty wifl be
assessed for each study or report listed. Thus.
Unit EB.lx has been added to the CAP
                I as follow*
                 have heeaiepoiuhh aider
                 ihea aonally ebuoMd by ihe
               I sBbessMS to «he lecnon 8f« >
               (•d betoe Inoe 18.1991).-^
           in wnBog to and leeoved by EP A
8(e) Compucnas Audit Program. The TSCA
Section 8(e) Compliaace Audit Program ia a
                          [TSCA
developed to obtam t
                                         A. Jtafisvettoi Ktqmranaaa
                                          The regisntian deadline/audit
                                                     i date has been extended for
 EPA. or 00 neeived by aw Office of Twue
 5igii-Bi •! (OTS) on • "For Your lafonnaocn
 ("KYI") bans and actatod in uw fomwl O"P>
 "PW Bong sysum: The Retulstee will bn --'
                                                        108
-------
                                                     **»
t !
d» TSCA SMta KM) Policy
         llj 199IX •«• 0)

                   TTTfl nr
                 ID Urii HBJ of «•* CAP   A»cribed .hr>« ead rrfeKaoed intae CAP    involving ocmSc-nt <
                                                                                        should be obmiaed under the
                                        TSCA MAoo8(e) require, reporting of     testsoioiysUB.-T*rfTSCAieciionS(e)
                                       iformirinn which reejoa-bry loppeta IBB     mfleed of relying oaPera V(bXD or V(c) of
                                              imtf •caemicel.i.M.Bceor       dM TSCA Soaioa 8(0) PolkySutemeni.
                                              	1 efabniBBBl rick of injury     Evan though EPA is (uxpending (he
                                                  "*• lf£Sl£*!!ZZ .   «•"*•»/ of Pens V(bXl) ad V(e) of the
                                                  > could Mflllftdr iecttoB«Xe)   TSCASee.«8(e)IWicySu«.a.*p.new
                                            •  g^-"^-* *^"^ ^S^m-   •»«al|l2"_«M« •••"KCA Mcon>>(e)
                                      Sfl?I!S5Llr8!?11ir"' -^"Ti!k SL*TVr_™*   * lT?M''fcyfe'h? ,*f?"?ly *""•
                                      UBS guxuDoe n ooonecaon wnn IBB ISVA     • «m«-ifci«Mfn -y mirfititii ritnr irf rnriTn' nit
                                      B-^^8(e)CavBiaaBeAB._irVBpea.EPA  dkiaBV.nBBxa_Tb_iifeeoBainniic
                                              '  l«h_iPBrtV(bXl)-            Hiiii-iij -^"i-^-n Ti«-l«""«'"^Hf
                                                                                  , Unto TLB.1 of the CAP Agreement
                                                                              i boon modified • reed es fbltowt:
                                                                                               . te lUfabtM Adi
                                                     i pa«aUa               mri EPft'ignwimra rm i»mn fiju u .In a 'in U
                                                    with raprd ID the guicUnc*   1^ 1971. "Tiiimiiiii of Imryuiiiioa md
                                                   eoald lad to ownpaning    EnfarenmPalicr.NotiSaaanflf Subcuaul
                                      ante te TSCA SoniaaXo)CoaBliimM      Hi*" («JHU1110)CTSCA $«»»•<•) Policy
                                      AodftPiDBn.
                                        Theroftw. EPAjri«. BinitUlB.«Yi«w
C. A4ttbw to tte RCA
            ccnm type, of hMhfa effect!
           toswrincareqaeafrorame    . with other EPA ptognm offices. EPA
                        	                  other T    "  _
                                                             oftherefDlBttd   g(,)CoBniu«ee Audit Progrmm . roeeeuful
                                                                            masthre. EPA believes thtt providing the
                                                                                  8(e) reporting guide m well u the
                                                                                            the legulued oommururv
                                                                            «4iyp«icipt«iBitaTSCAS«non»..,
TCOA  **	_,_|r .~1 •	1  - -• ..ft........*   ^JH....).... AM^J* Bk.M...m alMM.1 b. «MM|.«|   •—>—•»——.—» •wDH*1HMHi —«J •""lpll.J»*l
TSCApo^saft^k^^e^brcement   ^f!!^^^^^^^^   ftot^ord.CAPAi^er.eam.y b.
    - ^ ••»— -* % --- *-m- _^_-*_
tCpQnlCUBjr OS uMUB CIMMi
                                      P« V(bX2) dm* (bX5) of EPA'. TSCA                 .^
                                            *•) PoSey SIMBMBL IB Manic       tastes IS. 1991.
                                             ' m    *  MM -— ** - iMMHkLMWMi
                                             nllTWlHinnH Of HUUMV nrVDIVnilj
tcparuUify of IBB health affKBi COM stodle.   incideBa of eu»iiuuu-gml cjOBUmiiudaa, or    IHt Doe. 91-77177 Rhd 77-97-01: 8:43 •«
• the TSCA «ecBB0 8(0) iopart-.g guide      odber pnriouely unknown -imetioni
                                                    109
-------
110
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                                                            1 of 2
          Support Information for Confidentiality Claims


      Information  submitted  under specific reporting  requirements
 of  t*e Toxic Substances Control Act (TSCA) or in support of TSCA
 is  subject  to the provisions of Section  14  of TSCA and to EPA's
 Regulations  on the Confidentiality  of  Business Information (see
 40  CFR Part  2).   You must comply with the  following procedures to
 assert a claim of confidentiality  for  the information  solicited
 in  the attached letter.  Failure to  follow these procedures fully
 at  the time  you submit  the/-in format ion  to  EPA  will be  interpreted
 by  the Agency  as  a waiver'of your claim of confidentiality.

 Asserting a  Claim

      Information  claimed as"confidential  must be clearly narked
 by  boxing,  circling or  underlining.   All pages containing such
 information  should  also be stamped  "CONFIDENTIAL".   Care should
 be  taken to ensure that these markings do  not  obscure the sub-
 mission's text.

 Sanitized Copy

     Two  copies   must  be7 submitted  of any  documents  containing
 information  claimed  as  confidential.    One  copy  should be com-
 plete,  with  the  information: being claimed as  confidential marked
 in  the manner described"in  the preceding paragraph.    The other
 copy  should  have  all of the  information  claimed as  confidential
 excised.  This version wtHTfbe  placed in EPA's Public  Files.

 Substantiating Claims of Confidentiality

     Detailed  written: responses to  the following? questions T.ust
 be provided at the ~tfine you "submit  information for  any port.'- o£
 the information you claim as confidential. Your responses  -  .old
 be  as  specific  as  possible,  with   examples  as  appropriate,  and
should provide substantiation arguments for  all  types of informa-
tion  (e.g.,   sales  or  production/importation  volumes,  chemical
 identity, company identity) you claim as confidential.

     1.  For  what period  of time  do  you- assert  this claim  of
         confidentiality?"    If  a  claim, i*   to  extend  until  a
         certain  event,.or  point in time,  please  indicate  that
         event  or  time period.     Explain  why  the  information
         should remain confidential  until  such event or time.

     2.  Have  there been any confidentiality  determinations  made
         by EPA,  other  Federal agencies,  or  courts  in connection
         with  this information? If  so, please enclose copies.
                            Ill
-------
 3.   Has  any  of the  information that  you are  claiming  as
     confidential  been disclosed  to  individuals outside your
     company?   Will  it  be  disclosed to  such  persons  in the
     future?   If so, what restrictions,  if any, apply to use
     or  further  disclosure of  the  information?

 4.   Briefly describe  any physical or procedural restrictions
     within  your company relating to the  use  and storage of
     the  information you are claiming as confidential.  What
     other steps, if any, have you taken to prevent undesired
     disclosure  of  the information, during its use or when an
     employee  leaves your company?

 5.   Does  the  information claimed as confidential  appear or
     is  it referred  to in any of  items listed below:

     - advertising or  promotional materials for the chemical
      or the  end product containing it;

     - safety  data sheets or other similar materials for the
      chemical  or the end product containing it;

     - professional  or trade publications; or

     - any other media available  to  the public or to your
      competitors.

     If  you  answered yes to any  of  the  above questions, you
    must indicate  where the information appears and  explain
    why it should nonetheless be  treated as confidential.

6.  Would disclosure of this  information be likely to result
     in  substantial  harm to your competitive  position?  If
    so, you  must specifically describe  the alleged  harmful
    effects and indicate why  they should be considered  to be
    substantial.   Also, you must describe how disclosure of
    the information would cause  the harm.

7.  If  the  information  in  question  is "health  and  safety
    data* pursuant  to 40 CFR  Part 2.306(3)(i), do you assert
    that disclosure of  the information  you are claiming as
    confidential would  reveals

         a)  confidential process information;

         b)  confidential proportions of a mixture; or

         e)   information unrelated  to the  effects of  the
              substance  on human  health or  the  environment?

    If your answer  to any of  the above questions is  yes, yc.
    must explain how  such information would  be revealed.
                       112
-------
                       APPENDIX 13

 FINAL RULE: CHEMICAL IMPORTS AND EXPORTS; GENERAL IMPORT
REQUIREMENTS AND RESTRICTIONS POLICY FOR IMPORT OF CHEMICAL
                       SUBSTANCES
                       48 TO 55462-65'
-------
                 FR/  Vol  48.  No.  24Q/ Tuesday.  December 13.  1983
40 CPU Pajt TOT
                                EPA policy an addnsaod in the
                                preamble to the final Cmtoma rate.
                                which waa published IB tha Federal
                                Raftotar of AofUM 1.1983 (48 FR 347341.
                                The final rate and policy adopted
                          *         MvonJiuffeetfonaBadaby
AfBBsrfEPA).
       ftnelrate.
         Tote payer apiaiaa haw.
EPA win iatarpnt end cany outite
retpoambillaea ander the Toxic

13
      bythoU.8.
                                 The Diatoms ruk nquim.tmpaiti»
                                of efcimial rabmaai IB baffle or u
                               -put of ••mtxtnn labiMt to TSCA la
CUBp^y WtiB TSCA. BCCBBM MBH
                  daa) ore ant

           rate mpiim uopanvi to
                                                                        minufa>.tia«ia, (ha itapoaaibiiioe> *;
                                                                        axtafld to iBportan*
                                                                          Tbo TSCA nfutenoaa chat ippiy :t
                                                                        BBOOftan. baeauM thty an dafintd J
                                                                        ounufaetuiwsi uieluda amoai other.
                                                                        Uuap. Mctfon 5 ruin for chiaucai
                                                                        nibataacM aot OB tha TSCA Inventot
                                                                        ud for ehaaucala iub|«ci to nooficat
                                                                        for ugBifleaat saw UM*. and other
                                                                        auaufaenin or uaa rastnenana undai
                                                                        Mcnoa & Importer* ouat comply wit
                                                                        tuch ratea Oder seenoa 3 and seeno-
                                                                        beforaxheaocaie nay bo imponed.
                                                                        Importer! oay also be niDT«ct to exp
                                                                        aodfleatoB raqniremeati imder aeeti
                                                                        12 whaa mary ia deaied for IB tauao
                                                                        import. «ui me importer <±oas« is
                                !&•
                                            TSCA. Tai ra

                                                                      la additioB. b
34734). aad la codified is 19 cn.lU3»
(hroultl) UU7. ad 12TJI (amended}.
Tho eSectfva data of the Canons rate
             tO I vaaBttaVV le
         IB t&al i
                                 GaMM BI* tte raspoBBbiUty to
                                datwB ell lUaBMaa that nul to ooB^iy
                                with, TSCA OF my appUcBbte nte at
                                         tTSCA.BPA'1
                                                 r A* rate an to
rTae<
                datt of ttta peflcy to
Jack P. McCarthy. Dfnetor. TSCA
AaefansBca OBkvfTS-TMI. Office of
ToKte Substances, auliuiiiiieimr.
                                                  comply, to notify
                                                  UpBaaaiaaaldt
                                    dttaBMd. and to uteadry atapi
                                             to btBudaiauwd
                                                  or ttba takes whaa
                                             afOBOt ••••B^* IBtO
                                                        itscatevaat
                                    kaowtedft and axpartia. EPA if atea
                                                       aaddUpoaalof
                                                     e TSCA defines
                                    imponan ae ouBufictunn. importer
                                    may bo lubiaet to ruin inch •• mac
                                                     ectioa 4 end
                                                     ia under socdoB
                                                  nae tuea rein do at
                                    apply to nufvidQBl cheBBcai snipsier
                                    and becauae rmnpHanrw with neb n.
                                    nuy bo a tenfthy (UUueUure. imperial
                                    would not depend oa tha) anponan'
                                    Mdanctiaa«f aaettea 4^pd teettoa (
                                    teqmremaata. However.'if a MettoB  4
                                    6 rote raouxrao oottflcatloa of EPA pr
                                    to tha import of a ipeofied  '*—«"-'
                                    any impenat oTtbat chaBueai inould
                                              It dooooot
                                              ^^^•rt m&A
                                          with TSCA, Tho-
                                                                         i dttt tba raoured nonficasoa.
                                                                    been completed before eamfyug the-
                                                                                    I tba chemical la i
Control Art rOUACauj-wUc
puUiaaodmtbaFnacBlEeitetar
                                    TSCA:

                                      (Ha
                                             	         rTSCAte
                                            I ia tba' kcuteavo Uawry of
rote. The SPA pattcy is cedtfledi
CPU with other EPA ratea. It erase*
refenacea tha GisaaBa rate aliaCPIl
Part U.
  Commeata that wen received OB the?
proposed Cuatama rate aad propoaed
                                                                      Impotten an mbract aa

                                                                    vratedoas of TSCA, Seedoa 16 of TS<

                                                                    pinsltlsi wmch may be invoked.
                                                                          17 and 17 provide for tpeofic
                                                                             t of TSCA by the district
                                                                        »of the- United States, and for
                                                                                     inoaof
                                                                               • chemical subattucea.
                                                                               k artcka by praeen of
                                                                    DboL If as imparted thipment doee n
                                                                    comply with TSCA. EPA will seek
                                                                    appropriate ramedin under TSCA
                                                                    eaejBst aaKBOBa rasponaible for the
                                                                    vtolajfoas. Tha aaacnana an a add!
                                                                    to thaw which may independently b
                                                                    prescribed for vtoladan of the Custa
                                                                    rate.
                                                                          |of(
                                addlttaata
                                oanufactor»(Mcdoa Oft
                                2002(7)). CoaeeojuoBtlyi
                                plaenrHpoanbiilttet
                                                                TSCA
                                           i with TSCA. and (hat aa
                                                  iharBBd all the ISO
                                              related to the impact, ia
                                    acflBBmiiahed by a brief auiemoaitt)
                                    typed of praprunad OB aa tmry
                                    flflCflaBaaBlaW imBV^aMSaV QK B l^Xa^S^Ba^Bb ImB
                                    be OBBOd by the- importer. ~i»e
                                    itatanaBtwoaldtaaa; : ^r=fy that
                                    cheaucal fttbataaeai Ji •*'* uuomea
                                    comply with afi applicant -m» uno
                                    TSCA and that 1 am aot :J«r.ng a
                                    cheaucal aubetance for nor A viola
-------
                         / VoL «, No. 240 V
                            13. tap /  ftnJaa *od
 of TSCA or any
 andarTSCA.-
   Tho-aaeMos U j»ir
 to etrtfr that aihar
  Tha fiaal Cuafoau J«loj«oviBH
 TSCA («4~ pnoadM) to atantao
 •Uttaac "Ixartfy th
 ^u« shipacai an not Aubjact** TSCA."
 Thii was addodio tho rola.at tho

 conenMd About poatibU dalty* at
 aaBy porta.
 of omiptimo wttfa T9CA If
 J»k^^^MMk ^M^M^^BAAA^^M^l^^^Mj ^M kajk ^M
 rnitrnrat tunvieM utpartM JB nac or
 M put of suxturn. Tto ecrtflcitioD
 rtflQBIBBBt DCCOBWfl Ci8CttW JIBBVT
 1.1984.              _
  TM mn OOM sat ct^viiv cBrtfinttaB
 far rhtmical mbranen tiupuiud u
 put of ntteln view EPA Mqaam
 reportnf imdcr • TSCAnte.Th«
 pnBftiy FUMB for oot rv^wnB^
 artficBttea of «U-4iticlOT ct ttaii
 ttu dJBcuhyp tdnttfrte  «t»«ir
Biximn for pupuMi
wtwthtr ttey w« OB tht TSCAOwmmi
Subftaact Invmtoty. Ai thatiaw. then
•n ao TSCA niei which -apply t»
vtiein. Howwv. fsnnTSCA^
may apply to artd«4
TSCA rulot «hi£h tppir-to arteloB «U
TSCAioedOBa(o).to
UabiiUy whoa iht
uuatutoi •
praetdun. Tho rulo
pnaabioiolho
ponoawbo oartaloo »
tha oudl o/hi>
dtMnttoato
liabitltyiax
  la thia paliejr.
ralarasoa to tho (
ThU adopts tho t
daaatttoB tt 1»cn WUlk). Too
daflaitioa i* rapoaiod hero for
C o* Pan 14« oTChapttrl a l§m.

TSCA
takca nador a»eflflM4.4.4ad 7 «l
•ran. CaaaoaMBflit. it Mfll h*

inform** ofTSCA mbaTBua
CUTTVBt nQUlf
btlow. To obtun tddtteaal I
«• TSCA nJofc l
th.TSCAi
                                                       icctloo 3
                                                         taditnlta
the
•bout
othar afomattaa by wtittni or
tho TSCA Aanitnoa Offlaa. at
                                                                      amj.
                                                                                               edin tho
                                                      Cafliflcatiaa of
                                                               that
                                        i adMa ptoaibiten* or

                                   or dtoMbaOen BBdar toefloaa 5(t], Sffl.

                                                  t* bo awar* al ntiaa
roan noiunrnono.
TSCAloipoMiu
                       S(a]HJ of
                   tarn
           loapenoai-waeaiandto
import atw rhitmiril -"t»*««»*-«^*>i tha
Uaitod Stataa, Janoaa who:
        i la bulk. JB aux*Daa.«r m
      i is otdar to uasn thai
appUcabianlw aavt boon abaancd.
  A eammootaryoBtad oot4hat a
    story must raborit enmaouiaemf*
                 iS. 90 days prior 4o
                                                                                        •nCAmttjbflator
uoport.IfaehaoueaituhataaeBj«aot4a
tho toantory. i»> iinporu&oo would
comply wtth TSCAjvauinmutt 01% Jt
[a) tto chtntcal nbmna had  __

OT [Dj It^MIV VXHDpt'&QBlVaCBQB 5
                                                                      Tliiiiiiiiiinaiai iifcaillfllail
                                                                      woaUbora^oaatbiaca Ate AttMuo.


                                                                      ataatar to t
  A chanucal lubiUnca la coaridorod to
bo oa tho lavenury if it u on tha EPA
Klutat Inventory FUa.Thia ladudaa tha»
Boat recently publiahod
          or ravuwna) tad
                             Tha
totoa^butaatyatpabhahod.Th»

RoTiaadlBvoBoarjLThiaaoaabnaofth*
18BL tofttaavwith ihv Guanlattn
liimiliiinaia ynbuahod a July IMa
May 180.
  Too usportar oanifieaiioa appiioa ooJy
to rhrmicai wbauaoaa mtaneaaaily
                                                                      bauaoollBaay
-------
53464    P«doral Beglaiai / VoL 48. No. 240 / Tuesday. December 11 1963 / Rules and  Regulations
                              that
comply wimTSCA aad say applicable
regulations under TSCA.
  WneaOVBr the QiQVUBSBtS-
eCLUUlpOayine the imported Shipment
identify d» chemical substances
•xactiyrthe person who is certifying
                     der TSCA.
•gainn requiremen
When tho «*•••«••) substa

daw not identify It exactly. tad no
pOTOOD COfUyl&f OOOO aWt^tnOWFlOO
now tJif ifloutily- ho uoura-Attanpt to
ulACOVV tBO CPOBBJCeU COOflOtBIBtB OK t&O
                                      mtemational agreement is reached EPA
                                      would be prepared to modify this poiiey
                                      u needed. However. EPA considers that
                                      the TSCA section 13 policy complin
                                      with the principles' of tho international
                                      Standards ^"tr In addition, tho
                                      certification required by tho  section 13
                                      ralo u dcaimiod to •ckBowiodfo
                                                 with TSCA roqwramoBtt
foreign maafacturer). Tata persoa may
be *frie to identify tfa* components of


compiles with TSCA. Tho greater tho
~-«»i^ __ i                •
exxonaa i
                                      that an also la affact for domestically
                                        Aa~ analysis of too ladnsoy cost of
                                      impntar CBrtflcatioa was piaparad ia
                                      coapactioa with dovslopmont of tho
                                      tocttoa 13 rula issood by tho UA
                                      Cusfows Stfvie* (MS 48 PR MTS&
                                      Aufust 1. 1973). This policy statement
                                                  sts beyond those
                                             13 rale.
           to have vtoiatod ToCA* tao
t^m^^t J^lAk ^Jt^J^m ^t lk^ i^H^^^M^M A^
SJBOQ iam eBora ox IBB mpwnar 10


obviate or mltfeato the aseessBeat of a
cnti peaalty oader sscttoa 16 of TSCA.
                                        Tho EPA public record for
                                      development of this import policy is
                                      docket OPTS ITfflTftfl All documents.
                                      indttdmc tao*Baal Customs rale, are
                                      available to dM public ia me OTS
                                      Resdias Room- Cram tflO eja. to 4dO pjs.
                                      oa woridas days m Rm. B-10T. 401M SC
                                      SW.Wasun|toa.O.C20«aaThis
Tide IV of
1979 (Pnh. L 98-39). That law provides
the legal framework for implementing
trade agreements entered into by no
United States: Title (V (Standards Code)
                                      Uot of Sublets IB «• CPK Port 707

                                      *^p***** Exports. Roportaf aad
Federal i
follow ia
taecraoaoBofi
      itonrei.
  The Standards Code is not intended to
rule* art
                                      (Sac.ULPab.L
                                      UJ.C2R2))
iatemattonal
                                        Therefore. 40 CFR Part 7071*
                                      amended by addiaf a now SubpartB
                                                    707 JB to reed es IbOowr
           i widaa no United States.
aad do aot servo) 10 eimiDjue) tamorted
pimlimn dut nOy meet the obfecttvee
of iocfa mess	 Tho Standards Code
             r. tsBt taenctes involved
             M^ .fc Jlif^ff^f tfrg,
                                      §7974
Boated B0 lees Cavorably thaa like
AlthooBh there are no existmf
iateraattoaml ataadards for control of
imported rhemirsla, at such time aa
                                        (a| Scape, (l) This statement
                                      addresses the policy of the
                                      Environmental Protection Asjency (EPA)

                                      multures, aad artlclee *"***** tecdoa 13
                                      of the Toxic Substances Control Act
                                      fTSCA: 13 U.S.C 2801 at seq.). la
                                      particular, it addresses aspects of the
reguiatioa promulgated by the Umted
Sletee Customs Service (Customs).
Department of the Treasury (19 CFR
12.118 through 12,127. sad 12728
[amended]) to implement section 13 of
TSCA. 13 US.C. 2812. Section 13
requires the Secretary of the Treesury to
refuse catty into the Customs territory
of the Umted Slates of e chemical
substance, mixture, or article if it does
not comply with rules m effect under
TSCA. or if it is offered for entry IB
violation of TSCA or rales or orders
under TSCA.
  (2) IB addition to mis statement of
policy. EPA will continue, as necessary.
to address problems associated with
imports tii ruiemsjung ana ouer actions
under individual sections of TSCA. i.e.
sections 4.3.8,7. a. aad 12. Sections 5.8.
aad 7 apply directly to imports subiect
to the section  13 requirements. Section
12 may apply to export of a shipment
that ia refused entry under section 13.
             have obligations under
             8: section 4 and 8
            for importers would not
apply to individual chemical shipments
aad thus an aot included under iecnon
13 requirements. Interested persons
should refer to the records of these
individual ralemaking actions for
specific iafermation and guidance.
  (b) Objfetrrm. (1) TSCA is intended
to be ***"*p*TnTHtr*T and assure
protection of Benin and the
environment from unreasonable risks
sssooatod with chemicals whether the
chemicals an  imported or produced
domestically. This iatsnt is manifested
by the inclusion of Importation in the
Acts definition of the term
"manufacture'*: **{M]eaufacture means

manufacture*  (is U.S.C. 2802(7]). Thus.
importers an nspoasible for insuring
that "fr**"***1 importation complies with
TSCA Joel aa domestic manufacturers
an respoasibls Cor insuring that

TSCA.
  (2)(l) Tho section 13 rale requires
importon to siga the following
itateneat for each import of chemical
subetaacs* subject to TSCA: "I certify
that ail chemical n\Htmmfn IB this
ihipmam comply with all applicable
ndss or oiden under TSCA and that I -
an aot offering a diemifal substance for
catty n vtoiattoa of TSCA or any
applicable rale or order under TSCA."
Too ceroflcatioa will document that, ui
accordance with TSCA. the importer has
takea the necessary steps to insure
                                                                                            13 rale requires
                                                                                                not subiect *o
                                                                                               ) to certify uiai
  (U)Tho
 aporta
TSCA(<
-------
          Federal  Register I VoL 4& No. 340 / Tueaday. December 13. 1983  / Rulee and Regulationi   S5463
 "•HP"""1* •"«'' 1***-* »• •« ••[iiiied     lieeetaent of • ctvil penalty under
 Impenen matt certify thia by atgotaf      MctteaUol TSCA,                    laoa Six* Aveeee, Seattle. WAHioiia
 the iuiemenc-1 certify that aO             [jj SPA mfaretmtnt (1) EPA aad        «*wan)
 chemical* a thia taipment are net        Onteeu will monitor chemical aapone     (UiJ If Coateme detaiaa or rafuaea
 "W!l!*:yJi"*.*SEffi      l"**?^"*"""" aad their       entry of e ihipmeat (other than for
 IMMMMMM w v fv^ • • • •• —-^™™™          • vHUUveeaieiBeilV %»BIJ wBee EUBejlBBUHwW
 chemical not subject to TSCA.           maadataa oTTSCA. Cmwmt will reraee     	  ^ ^    «. «., „„,,. «.„,
  (3) The United State* ia involved ta e    entry ta any ehipaMat «•**! «~* *H»« gj    iufjiiiL'*Y with the renininiiieiiii of
 meter tffen toward BtBnaaeaal         the certification ta properly eaaauttad.     TSCA, SPA offloala wiU reaueea the
 Banaeniuaea m tae conooi a           Cuatoma will alao detam a ihipmeat tf     •>vp*Tmtt ta de**"1****^ Ita carreat
 chaaucala. At nichttme u tatenatloBal   there an reeaenabte troaada te believe   n^^jUm^^ ttetna.-Whea e ehipmeat ia
 agwementu reaped on U»i»l»»oe.BPA.   that each ahtpmeat or ita hsport vioktee   ao loneer m violation, EPA will notify
 would be prepared tomodiry tta paoey V   TTTA or fegnlatlona or orrtari            thadtaMctdbeeteraadthamiponer.
 uocuMTy.O'A believe* that tta          thenaader. A vialattve ahipmeat anat     The dtatrlet dtoectar will then releaae
 mteioatioBaJbanumiutaeffattia     either be brought ate compliance.         the ihipment Tale aoOee will alao terve
 ine cocffol of caamieau wul piuiaet       exported, destroyed, or voloatanly        aa a determiBatton te permit entry under
 k^^le>ai *^^1 ftBft^ ^ieaMeeeMi^^H^^e> M«ekJt^          i    •   •  ..•_•_.•  .>	»_•_        ^^ ^^^^b ^^. ^^^* • >•   c .     . , f     .
                                            .         .
health tad tho«avw«mentwhito         «budenod wtthto thodmo porioda       19GFRl2J23(e)if •ihipBunt is brought
hiUIlliD«ittobUfattnuuBdardMTndo    piweriboduUCFIllUMeftai         toto eoBBttuet bota* tho 19 CFR
A*wmonttActofl»79.                 HcttoalSniio.                        liU3(c) decKttaMuktav proem hu
  (c) nto eocooBxym^ll Ceoaniy       (li) When EPA ditenmnee that t       bewoomptotod. If cnmpJUaale
                                     identify the reaaoaa for the deteatioa      ilaieiinlimiiili (advene to the importer)
                                     and thi necaiaaij actiom for en          baa been made, the EPA notice to the"
                                     intportcrtabrtnf the ibipment into       «amdreBtBrvriOMrvauanvenel
                                                ith TSCA, If SPA baa       of tedeoataB ta lenaa entry.
                                        diitrict director
                                     nptieB.ihaiBfiam«oanwillboeBDMp«ii
                       .-.
   ,--            •houldeoBMCloMofttofaltowhBjEPA
eortrrof a etttamaat en
                                                              _          AaeBcv an M 8t_ SW WaahtoetoiL
^chmteai tabatMce eabject to        dnde      thtmii«m.             OC aiOO. TeU bta (aOMM^OBB). In
TS^impoitedBbaJkoraapaitofa                       """• •             Wejatefton. OC (S»»-l«MV Ontnda
mixtara. anrpliy with TSCA. and that    lealeal                              the USA (Opanter^OMS4.t40«).
it ia not offered for antty m violation of
TSCA or any rale or order oader TSCA.
or that tho chemwaia imported an not
nibiect to TSCA.
  (U)ThocevtiflcationappUeatoTSCA
UCttOeU 0k Q« AUO 7m
  (Ui) EPA expecta that BJa i
wtUbetMMdopontctulkDowiedsoaf
the:        -            -
EPA naliSM that •omaomei tmporu
may not have actual louwledee of the
           apt
iheuld attempt to aJauwat taa
cenatituenta of the ihipmeBtby
contacting another party ta eat
tranaaeaon (04. hia prmdpal or the
foreign manq/aeturerj. Thto peraea may

the Buxtara. or at leeat itate that the
tubatancee comply with TSCA. The
greater the effort as fnipirMaf makea ta
learn i
TSCA, the emeiler hlaehaaoeof
     itaai a Tiolattenby tmportae, a
                                                                 «-
TSCA, the food faith cfferti of the
importer to verify eompUaaee. aa
evideBBed by documeata oontaiaed in     aa Piienrni 8awt Sea PtMoeco. CA seioa
hia fllea. may obviate or mitigate the        (4is-ar+-nu)
                                            Oeerboro SirMt OucafD. 0.
-------
                          APPENDIX 14

ANNOUNCEMENT OF POLICY AND NOTICE? FOR PUBLIC COMMENTS COORDINATES
           FRAMEWORK FOR REGULATIONlOF BIOTE
MMENTS C
HNOLOGY
-------
Tnureday
June 26, 1986
Part II

Office of Science
and Technology
Policy	
Coordinated Framework for Regulation of
Biotechnology! Annooncement of Poftcy
and Notice for Public Comment
-------
23302
Federal  Register / VoL 51. No. 123  /  Thursday,  [une 26. 1966 / Notices
OFFICE OF SCIENCE AND
TECHNOLOGY POLICY

Coordinated Framework for
Regulation of Biotechnology

AOIMCY: Executive Office of the
President. Office of Science and
Technology Policy.
ACTION: Announcement of policy: notice
for public comment.

SUMMARY: This Federal Register notice
announces the policy of the federal
agencies involved with the review of
biotechnology research and products.
As certain concepts are new to this
policy, and will be the subject of
rulerr.sk'.ng. the public is invited to
comment cr. these aspects which are
specifically identified herein.
OATK Comments must be received on or
before August 25.1988.
  Public Participation: The Domestic
Policy Council Working Croup on
Biotechnology through the Office of
Science and Technology Policy, is
seeking advice on certain refinements
published herein to the previously
published proposed coordinated
framework for regulation of
biotechnology. These new aspects
include the Biotechnology Science
Codrdinating Committee's (BSCCs)
definitions for an "intergeneric organism
(new organism)" and for "pathogen."
These definitions are critical to the
coordinated framework for the
regulation of biotechnology because
they establish the types of the organisms
subject to certain kinds of review.
  It is the intention of the Domestic
Policy Council Working Croup on
Biotechnology, the Biotechnology
Science Coordinating Committee
(BSCC). the Department of Agriculture
(USDA). the Environmental Protection
Agency (EPA), the Food and Drug
Administration (FDA), the National
Institutes of Health (NIH). the National
Science Foundation (NSF). and .the
Occupational Safety and Health
Admir.is'rqtion (OSHA) that the policies
contained herein be effective
immediately. In consideration of
comments, modifications, if any. may be
published either in a separate notice or
as part of proposed rulemaking by the
involved agencies.
  Information submitted to an agency
(hat  is trade secret information or
confidential business information should
be clearly marked so that it can be
accorded the protection provided to
such by each respective  agency.
AOOMMS: Comments specific to the
BSCC definitions or overall comments to
the Coordinated Framework for the
                   Regulation of Biotechnology statement!,
                   should be addressed to: BSCC Docket
                   *BSCC 0001. Office of Science and
                   Technology Policy. Executive Office of
                   the President. NEOB-Room 5005.
                   Washington. DC 20508.
                     Comments relating to the policy
                   statements of a particular agency should
                   be sent directly to the agency contact
                   identified at the beginning of the
                   respective agency policy statement
                   PON FURTHER INFORMATION CONTACT:
                   Dr. David T. Kingsbury. Assistant
                   Director for Biological Behavioral, and
                   Social Sciences. National Science
                   Foundation.  1800 G Street. N.W..
                   Washington. D.C. 20550. (202-357-9854).
                   |«ry 0. leaning*.
                   Executive Director. Office sf Science and
                   Technology Policy
                   lune 1& 1986
                   Table of Counts
                   I. Preamble
                     A. Introduction
                     B. The Coordinated Framework for the
                       Regulation of Biotechnology
                     C. Interagency Coordination Mechanisms
                     0. BSCC Definitions
                     E. International*Aspects
                   IL Statements of Policy
                     A. Food and Drug Administration
                     B. Environmental Protection Agency
                     C U.S. Department of Agriculture  •
                     D. Occupational Safety and Health
                       Administration
                     B. National Institutes of Health
                     This notice describes the
                    comprehensive federal regulatory policy
                    for ensuring the safety of biotechnology
                    research and products. Specifically
                    addressed are agency policies that
                    formed part of the previously proposed
                    Coordinated Framework for the
                    Regulation of Biotechnology, published
                    in the Federal Register December 31.
                    1984 (49 FR 50858. hereinafter "the
                    December 84 Notice"). These agency
                    policies build upon experience with
                    agricultural pharmaceutical, and other
                    commercial products developed by
                    traditional genetic modification
                    techniques.
                      Existing statutes provide a basic
                    network of agency jurisdiction over both
                    research and products: this network
                    forms the basis of this coordinated
                    framework and helps assure reasonable
                    safeguards for the public. This
                    framework is expected to evolve in
                    accord with the experiences of the
                    industry and the agencies, and. thus.
                    modifications may need to be made
                    through administrative or legislative
                    actions.
                      The application of 'raditional genetic
                    modification technic  -•-. is relied upon
                    broadly for enhanc.    - iractenstics of
food (e.g.. hybrid com. selective
breeding), manufactured food (e.g..
bread, cheese, yogurt), waste disposal
(e.g.. bacterial sewage treatment),
medicine (e.g.. vaccines, hormones).
pesticides (e.g. Bacilliu thunngieasu)
and other uses. Federal agencies
implement an array of laws which seek
to ensure the safety of these products. A
concise index of these U.S. laws was
published in the Federal Register
November 14.1985 (50 FR 47174.
hereinafter '/the November 85 Notice").
These laws an product-specific because
they regulate certain product uses, such
as foods or pesticides. This approach
provides the opportunity for similar
products to be treated similarly by
particular regulatory agencies.
  Biotechnology aiso includes recently
developed and newly emerging genetic
manipulation technologies, such as
recombinant DNA (rDNA). recombinant
RNA (rRNA) and cell fusion, that are
sometimes referred to as genetic
engineering. While the recently
developed methods an an extension of
traditional manipulations that can
produce similar or identical  products.
they enable  more precise genetic
modifications, and therefore hold the
promise for exciting innovation and nev
anas of commercial opportunity.
  Concerns wen raised as to whether
products resulting from the recently
developed techniques would pose
greater risks than those achieved
through traditional manipulation
techniques. For example, what might be
the possible environmental
consequences of the many anticipated
agricultural and environmental
applications that will take place outside
the physical constraints of a contained
facility? In particular, the environmental
application of genetically engineered
microorganisms may elicit concern
because they an of microscopic size.
and some may be able to reproduce.
proliferate, and become established.
  The underlying policy question was
whether the regulatory framework that
pertained to products developed by
traditional genetic manipulation
techniques was adequate for products
obtained with the new techniques. A
similar question arose regarding the
sufficiency of the review process for
research conducted for agricultural and
environmental application*.
   The Administration, recognizing us
responsibility to confront these
concerns, formed an interagency
 working group under the former Whi-p
 House Cabinet Council on Natural
 Resources and the Environment in -bo
 spring of 1984. The  working group «* .  •
 to achieve a balance between regu ,.  -
-------
                    Federal Register / Vol SI.' No.  123 / Thursday, frag 26. 1986 /  Notices
adequate to ensure health and
environmental safety while maintaining
sufficient regulatory flexibility to avoid
impeding the growth of an infant
industry.
  Upon examination of the existing laws
available for the regulation of products
developed by traditional genetic
manipulation techniques, the working
group concluded that for the most part.
these laws as currently implemented
would address regulatory needs
adequately. For  certain microbial
products, however, additional regulatory
requirements, available under existing
statutory authority, needed to be
established.
  The existing health and safety laws
had the advantage that they could
provide more immediate regulatory
protection and certainty for the industry
than possible with the  implementation
of new legislation. Moreover, there did
not appear to be an alternative, unitary.
statutory approach since the very broad
spectrum of products obtained with
genetic engineering cut across many
product uses regulated by different
agencies.
  Because of the rapid growth in the
scientific knowledge base, the working
group felt strongly that the federal
agencies needed to have an interagency
mechanism for sharing scientific
information related to biotechnology.
particularly information on research and
product applications submitted to the
agencies.
  The December 1984 Notice described
the regulatory framework envisioned by
the working group, and recognizing the
evolutionary nature of its development.
asked for comments. In summary, the
Notice stated that the Food and Drug
Administration (FDA) would regulate
genetic engineering products no
differently that those achieved through
traditional techniques. The
Environmental Protection Agency (EPA)
described existing and proposed new
policies for regulating peaticidal and
nonpesticidal microorganisms. The
Department of Agriculture (USDA)
stated that under its different legislative
authorities it could broadly regulate
genetically engineered plants and
animals, and plant art4 ••<•«• I
pathogens. The  Notice also proposed an
interagency science coordinating
mechanism.
  Many comments were received in
response to the  Notice. These
contributed to the refinement of both the
regulatory requirements and the
interagency science coordination
mechanism.
  The interagency coordination
mechanism, the Biotechnology Science
Coordinating Committee (BSCC).
discussed in more detail ia sectioa & of
this Preamble, came into being while the
agencies were stiB in process) of refining
their regulatory proposals.
Consequently, the BSCC was able to
play a helpful role in the formulation of
two basic principles: (1) Agencies
should seek to adopt consistent
definitions of those genetically
engineered organisms subject to review
to the extent permitted by their
respective statutory authorities: and. (2)
agencies should utilize scientific reviews
of comparable rigor.                 ;
  The regulatory framework anticipates
that future scientific developments will
lead to further refinements. Experience
with earlier basic scientific research has
shown that as the science progressed
and became better understood by the
public, regulatory regimens could be
modified to reflect more complete
understanding of the potential risks
involved. Similar evolution is
anticipated in the regulation of
commercial products as scientists and
regulators learn to predict more
precisely particular product use that
require greater or lesser controls or even
exemption from any federal review.
  This framework has sought to
that require a certain level of federal'
review and those that do not This
follows a traditional approach to
regulation. Within agriculture, for
example, introductions of new plants,
nnimala and microorganisos have long
occurred routinely with only some of
those that are not native or are-
pathogenic requiring regulatory
approval. It should be noted that
microorganisms play many essential
and varied roles in agriculture and the
environment and that for decades
agricultrual scientists have endeavored
to exploit their advantages through
routine experimentation and'
introduction into the environment: and
as a rale these agricultural end
environmental introductions have taken
place without harm to the environment
B. IDS) GoofUBatae] Framework for flu
Regulation of Biotechnology
General Comments
  This notice includes separate
descriptions of the regulatory policies of
FDA. EPA. OSHA and USDA and the
research policies of the National
institutes of Health (NIH). NSF. EPA and
USDA. The agencies will seek to operate
their programs in an integrated and
coordinated fashion and together should
cover the full range of plants, animals
and microorganisms derived by the new
genetic engineering techniques. To the
extent possible, responsibility for a
product OH wiU be WMIJ a smgh agency.
Where regaauoiy eveoighi «r NVWW
for a particular product w to be
performed by snore than on* agency, the
policy establishes a lead agency, ami
consolidated or coordinated reviews.
While this preamble seeks io convey an
overview of the coordinated framework.
it must be noted that the regulatory
requirements  are highly technical:
reliance only on the simplified summary
statements herein could be misleading
and. tKus. the agency policy statements
must be consulted for specific details. In
the event that questions arise regarding
which federal agency has jurisdiction.
an information contact is provided at
the beginning of this notice.
  While in part certain USDA and EPA
requirements  are new. the underlying
regulatory regimens are not new.
Members of the agricultural and
industrial communities are familiar with
the general requirements under these
laws winch include the Federal Plant
Pest Act. The Plant Quarantine Act. the
Toxic Substances Control Act (TSCA).
and the Federal insecticide. Fungicide.
and Rodeaticide Act (FIFRAJ.
  Because this comprehensive    -£•
regulatory framework uses a mosaic of
existing federal law. some of the  ^
statutory nomenclature for certain
actions may seem inconsistent. Certain
laws, such as USDA's Federal Plant Pest
Act require a "permit" before a
microorganism pathogenic to plants may
be transported or imported. Under other
laws such as  FIFRA. the agencies
"license" or "approve" the use of
particular products. TSCA requires a
"premanufactunng notification (PMN)"
There are also some variations among
the agencies in the use of the phrase
"genetic enginering." Regardless of the
nomenclature, the public should be
aware that the reviews conducted by
each of the regulatory agencies are
intended to be of comparable ngor.
Agencies have agreed to have scientists
from each other's staff participate in
reviews. Each regulatory review will
require that the safety, or safety and
efficacy, of a particular agricultural or
industrial product be satisfactorily
demonstrated to the regulatory aaenrv
prior to commercialization.
   The National Environmenial Pohrv
Act (NEPA) imposes procedural
requirements on aD federal agenc<»s •'>
 prepare an analysis prior to ma km; <
 decision to take any action that rr ,•.
 significantly affect the environm*-.
 Depending on the characteristics  :
 proposal an environmental as<^- -
 or a broader environmental imc •
 statement may need to be prep .-
 connection with the release of
-------
23304
Federal  Register /  Vol. 51.  No. 123 /  Thursday.  June 26.  1986 / Notices
genetically manipulated organisms.
EPA's actions under most of its
environmental statutes have been
considered to be the functional
equivalent of NEPA compliance.
  For the handling of microorganisms.
agencies of (he Department of Health
and Human Services have established
recommendations for the safe use of
infectious agents. The CDC/MM
publication. Biosafety in
Microbiological and Biomedical
Laboratories, describes combinations of
standard and special microbiological
practices, safety equipment and
facilities which are recommended for
working with a variety of infectious
iger.t* irj research laboratories.
academic and industrial. The USDA also
has issued guidance on other infectious
agents.
  The NIH has published guidelines for
the contained use of ONA organisms in
the NIH Guidelines for Research
Involving Recombmant DNA
Molecules, Federal Register May 7.
1988 (51FR16958. NIH guidelines). The
guidelines recommend physical
containment at specific levels for
different experiments, and exempt other
experiments from containment
requirements. However, they
recommend Biosafety Level 1. the least
stnngent level of physical containment
for some "exempt" experiments. For
large-scale exempt experiments, the NIH
guidelines recommend "Biosafety Level
1-Large-Scale" although following
review by the Institutional Biosafety
Committee, "some latitude" in the
application of these requirements is
permitted.
  The appropriate large-scale
containment requirements for many Urn
risk ONA derived industrial
microorganisms will be no greater than
those appropriate for the unmodified
parental organisms. This concept is
discussed further in the Organization for
Economic Cooperation and
Development (OECD) document.
descnbed in the International Aspects
section below.
  OSHA in its Federal Register Notice
of April 12.1984 (SO FR 14468) stated
that its authority under the
Occupational Safety and Health Act of
1970 (29 U.S.C. et seq.) provides an
adequate and enforceable basis for
p-otecting the safety and health of
employees in the Held of biotechnology
and that no additional regulation is
necessary. After consideration of
comments in  the April 1984 notice.
OSHA is publishing this policy
statement in Final form without change.
                   Product Regulation
                     Agencies involved with regulating
                   agriculture, foods, medical devices.
                   drugs, biologies and pesticides have had
                   extensive experience with products that
                   involve living organisms in their
                   manufacture and/or ultimate use
                   including releases into the environment
                   for these purposes. By the time a
                   genetically engineered product is ready
                   for commercialization, it  will have
                   undergone substantial review and
                   testing during the research phase, and
                   thus, information regarding its safety
                   should be available. The manufacture
                   by the newer technologies of food, the
                   development of new drugs, medical
                   devices, biologies for humans and
                   animals, and pesticides, will be
                   reviewed by FDA. USDA and EPA in
                   essentially the same manner for safety
                   and efficacy as products obtained by
                   other techniques. The new products that
                   will be brought to market  will generally
                   fit within these agencies' review and
                   approval  regimens.
                     The regulatory scheme for products is
                   described in Chart I Coordinated
                   Framework—Marketing Approval of
                   Biotechnology Products.
                   CHART (.-^COORDINATEO  FRAMEWORK—AP-
                     PROVAL  Or COMMERCIAL  BWTECHNOLOOV
                     PRODUCTS
                        9*001
                                                FDA,*
                                                 rsa.'
                                                FDA.

                                                APM&
                       Pitt
                       i Agneuftnl UM
                       I NOB igrnute* un.
                                                EPA.
                                                APHIS.*
                                                 PDA.'
                                                EM.*
                                                «PM
                                               I
EPA,'
 AP*
EPA Report.

APMS.
EPA,'
 APHIS'
EPA I
                     •LeMmncy
                     •FSiS, Food SoM* md
                   Acooani SMTMTV M AqneMm e*aon*ab nr toad ueei
                     •FOAMmd*«M wmi n ruroenjp • modueo.

                   IMOfc*90 Vfl0n VM ffVOOOTQaWn • QltVH P*HL IHMi
                   gin or reojuttea MM requmg • penM.
                     •EPA raowemenB «• ony IPO* «
                          i • agnojni HOT ueo nt» «• EPA •
                     Jurisdiction over the varied
                   biotechnology products is determined by
                   their use. as has been the case for
                   traditional products. The detailed
                   description of the products and their
                   review are found in the individual
agency policy statements contained in
this Federal Register Notice. The
following is a brief summary of
jurisdiction as described in Chart I.
  Foods, food additives, human drugs.
biologies and devices, and animal drugs
are reviewed or licensed by the FDA.
Food products prepared from domestic
livestock and poultry are under the
jurisdiction of the USDA's Food Safety
Inspection Service (FSIS).
  Animal biologies an reviewed by the
Animal and Plant Health Inspection
Service. (APHIS). APHIS also reviews
plants, seeds, animal biologies, plant
pests, animal pathogens and "regulated
articles", i.e.. certain genetically
engineered organisms containing genetic
material from a plant pest An APHIS
permit is required prior to the shipment
(movement) or release into the
environment of regulated articles, or the
shipment of a plant pest or animal
pathogen.
  "Other contained uses" refers to the
closed system uses of those
microorganisms, subject the TSCA. that
are intergenenc combinations, i.e..
deliberately  formed microorganisms
which contain genetic material from
dissimilar source organisms. These are
subject to EPA's PMN requirement. EPA
is considering promulgating a rule to
exempt certain classes of
microorganisms from this requirement.
  Microbial pesticides will be reviewed
by EPA. with APHIS involvement in
cases when the pesticide is also a plant
pest animal pathogen, or regulated
article requiring a permit. (FDA may
become involved in implementing
pesticide tolerances for foods.)
  "Other uses (microorganisms)"
include uses involving release into the
environment For these, jurisdiction
depends on the characteristics of the
organism as well as its use.
"Intergeneric combination"*
microorganisms will be reported to EPA
under PMN requirements, with APHIS
Involvement in cases where the
microorganism is also a regulated article
requiring a permit
  "Intrageneric combinations"  are these
microorganisms formed by genetic
engineering  other than intergenenc
combinations. For these, when there < j
pathogenic • source organism, and •*•-
microorganism is used for agncultu-.
purposes. APHIS has jurisdiction I'
microorganism is used for
nonagricultural purposes, then EP \
jurisdiction, with APHIS involver •
cases when the microorganism « •
            1 ••tntngenenc orguuuu (ntw orgin.i-
           • pathogen" on defined in lection 0 01 -
           preamble.
-------
                    Federal Register  /  Vol. 51.  No. 123  /  Thursday. |une 26. 1966  /  Notices
                                                                      23305
 regulated article requiring a permit.
 Intragenenc combinations with no
 pathogenic source organisms are under
 EPA lunsdiction although EPA will only
 require an informational report.
   Nonengmeered pathogens' that are
 used for an agricultural use will fall
 under APHIS jurisdiction. Those that are
 For a nonagncultural use come under
 EPA jurisdiction, wi'h APHIS
 involvement in cases where the
 microorganism is also a plant pest or
 animal pathogen requiring a permit
 Nonengmeered nonpathogenic
 microorganisms are under EPA
 jurisdiction which will require only an
 informational report.
 Research
  The coordinated framework for the
 regulation of biotechnology establishes
 requirements for the conduct of
 research.
  Approximately ten years ago the NIH
 issued  the NIH guidelines describing the
 manner in which research with
 organisms derived by rONA techniques
 should be conducted. Since then the
 guidelines have been modified many
 times with gradual relaxation of these
 requirements. The guidelines prescribe
 the conditions under which institutions
 which receive NIH funds must conduct
 expenments. For a very small category
 of NIH funded expenments including
 environmental release, the guidelines
 require that the Director. NIH. approve
 each experiment on an individual basis.
 For each of these expenments. the RAC
 conducts a scientific review with an
 opportunity for pubiic comment, and
 makes a recommendation to the NIH
 Director. As research expenments have
 expanded out of the biomedical area to
 environmental applications both
 agricultural and nonagncultural. other
agencies have become involved, with
shifting of responsibility for research  ..
approval  to NSF (described in the
 November 85 Notice). USDA's SftE. and
 EPA. These other agencies' policies
 bu.ld. in part on the NIH guidelines and
 MM experience.
  The S&E guideline* for agricultural
 research published separately for
comment in this Issue of the Federal
 Register have adopted the NIH
guidelines with certain modifications
 including expansion of the scope to
 manipulation techniques other than
 rDNA. the table included with the SftE
guidelines shows where particular
 elements  of the NIH guidelines are used.
  It should be noted that not all
 expenments involving the
 environmental release of genetically
 engineered organisms require pnor
 federal approval. In plant applications
 there is a substantial body of research
indicating that such expenments are of
low risk. For certain categories of
microorganisms modified by traditional
genetic modification techniques, there is
also a substantial body of research
indicating low risk for environmental
expenments.
  Chart II—Coordinated Framework—
Biotechnology Research Jurisdiction
shows which agency has responsibility
for a particular expenment. If more than
one agency has potential jurisdiction.
one agency has been designated as thex
lead agency and it is marked with an
asterisk on Chart (I. The lead agency
designation depends on which research
agency is funding the  research (e.g..
NIH  S&E. or NSF) or which regulator}
agency reviews specific purpose
research (e g pesticides). In the chart
and in this discussion, the authonty
refers to approval of the actual
execution of expenments and not to
their funding.

  CHART II —COORDINATED  FRAMEWORK—
  BnrecHNOLoav RESEARCH JURISDICTION
                 IDrugi.
                             POV MM
                            I FDA' MM
                              • • •
                              3KSV
                             EPA.'
       I IMC
                       KIM
                             EPA,*
                             EPA.'
CHART II —COORDINATED  FRAMEWORK—810-
  TECHNOLOOV  RESEARCH  JURISDICTION—
  Continued
                             EPA APHIS
                            •  S4E.
     i  ctomfec.
                              •P-iS
                              EPA-
                              EPA • i
     NO Pmeanc Sow* Organim*
                              Paeon •
                                                                      BPA.«
           i lor r«M*nn on a oat grtmr (ran -0

                      •nwornwur -n*iK-
  For contained federally funded ^
research for biomedical and agricultural
purposes, research approval will Be
granted by the funding agency The MH
guidelines relate primarily to biomedical
expenments and only to those using
rDNA techniques. Research on foods/
food additives, human drugs, medical
devices and biologies will continue to
rely on the NTH guidelines, with NIH
approval required for certain
expenments such as human gene
therapy, and FDA permission for cl.nical
tnals.
  Fashioned after the NIH guidelines.
the SftE guidelines apply to agricultural
research on plants, animals, and
microorganisms and provide guidance
for laboratory ancLCeld testing of
organisms derivedusiiuj rDNA
manipulation and other technologies
Adherence to the appropnate  set of
guidelines is required for institutions
receiving financial support from MH
S&E. or NSF These guidelines ;re- r\
what type of review procedures are
required for specific categories of
expenments.  Some expenments  res- r»
individual approval by the respect  e
agency providing institutional succc-
For those expenments that require
agency approval, advisory comn.    «
at NIK- SftE. and NSF. composed
primarily of nongovernment scie- •  •
may be asked to provide expert ••>
In addition, research on plants *   -
and animal biologies will come . -
APHIS permit requirements if a
regulated article, plant pest a- -
pathogen is involved. An APH"-
-------
23306
Federal  Register / Vol. 51. No. 123  /  Thursday,  [une 26. 1986 /  Notices
ii required prior to the shipment
(movement) or release of a regulated
article, or the importation or shipment of
a plant peal or regulated article used in
any research experiment.
  EPA has authority for all
environmental research on nucrobial
pesticides regardless of whether
research is federally funded or not. EPA
will regulate research under a two level
reiiew system baaed upon its evaluation
>f the potential risks posed by various
'ypes of mtcroorgfmicrrs with lesser
.1 Jtification required for !evei I reporting
ar.d full review fur level II.
  For the "other u*es" category from
Charl II (i?aearch involving
lonpesuctde microorganisms released
into the MvmaKiMi1,  jurisdiction for
release may be under S*E. NSF. APHIS.
 •r EPA depending primari!) upon the
.-ource of the funding but aleo upon the
^urpose of the research and the
characteristics of the ?ene»ica"y
engineered microorganism. Thus.
federally funded research conducted for
:n agricultural use will require
adherence to S4E guidelines and
Approval of certain experiments by S&E
or NIH depending on which is the
funding agency. EPA will review
commercial research. APHIS'S
jurisdiction applies to issuing permits for
~egulated articles, plant pests, or animal
pathogens. EPA will require an
informational report farnonengineered
microorganisms released into the
environment, with APHIS involvement
for the review of plant pests or animal
pathogens.
  There may be situation* where one
agency may choose to defer to. or ask
advice from, another agency.  If
experiments requiring NIH. NSF or SftE
review/approval an submitted for
review to another agency, then NIH.
NSF. or SaE may determine that such
review serves the same purpose, and
based upon that determination, notify
the  submitter that no NIH. NSF. or S&E
review will lake place, and the
experiment may proceed upon approval
frcm the ether agency.

C. Interagency Coordination
Mechanisms

The Domestic Policy Council Working
Croup on Biotechnology
  The Domestic Policy Council Working
Croup on Biotechnology has been
responsible for this coordinated
framework for the regulation of
biotechnology: it also considers policy
matters related to agency jurisdiction.
commercialization, and international
biotechnology matters. The Working
Group monitors developments in
biotechnology and is ready to identify
                   problems and make appropriate
                   recommendations for their solution. The
                   Domestic Policy Council Working Croup
                   on Biotechnology is a continuation of a
                   similar group established under the
                   former Cabinet Council on Natural
                   Resources and the Environment.
                     Although at the present time existing
                   statutes seem adequate to deal with the
                   emerging processes and products of
                   modern biotechnology, there always can
                   be potential problems and deficiencies
                   in the regulatory apparatus in a fast
                   moving Reid, The Working Croup will
                   be alert to the implications these
                   changes will have on regulation, and in
                   a timely fashion will make appropriate
                   recommendations for administrative or
                   legislative action.

                   The Biotechnology Science
                   Coordinating Committee (BSCC)
                     The BSCC is responsible for
                   coordination and consistency of
                   scientific policy and scientific reviews.
                   The BSCC. established October 31.1983
                   as part of the Federal Coordinating
                   Council for Science. Engineering and
                   Technology (FCCSET), consists of senior
                   policy officials of agencies involved in
                   the oversight of biotechnology research
                   and products. FCCSET is a statutory
                   mteragency coordinating mechanism
                   managed by the Office of Science and
                   Technology Policy. Executive Office of
                   the President with a mission to
                   coordinate federal science activities
                   among federal agencies. The November
                   85 Notice described the structure and
                   activities of the BSCC.
                     One of the primary activities of the
                   BSCC has been the development of
                   definitions because a common scientific
                   approach is essential to a coordinated
                   federal regulatory framework. The
                   underlying scientific issue, therefore.
                   was defining those organisms subject to
                   certain types of agency review.
                     The definitions are included in the
                   following section of this preamble and
                   have been incorporated, with
                   modification, into the individual policy
                   notices of the involved  agencies
                   Explanatory material is aJso included in
                   the agency policy statements. As
                   mentioned elsewhere, the BSCC is
                   seeking comments on these  definitions.
                     Research to develop genetically
                   modified organisms for environmental
                   and agricultural applications (as for
                   research on traditionally modified
                   organisms) generally proceeds in a step-
                   wise manner from highly contained
                   facilities to progressively lesser degrees
                   of containment as  the investigator
                   determines the safety and efficacy of
                   experimental applications: these are
                   conducted sequentially under controlled
                   laboratory conditions, greenhouse
testing, small field trials, and full field
trials. The BSCC recognizes the need for
further work to define me nature and
extent of physical and biological
barriers that limit or manage
environmental release of modified
organisms during greenhouse testing and
held research.
  The BSCC is authorized to hold public
meetings in order to discuss public
concerns about scientific and other
issues Accordingly, the BSCC will hold
its first public meeting shortly after
publication of thu nonce for discuss en
of ihe scientific aspects cf this nufce
and The receipt of comments from (Le
public. The public meeting will be he'd
in futy 1986. Details regarding nine and
location will be separately announced -n
the Federal Register.

O. BSCC Definitions
  Any proposal to regulate the research
and products of genetic manipulation
techniques quickly confronts the issue of
what organisms should be considered
appropriate for certain types of review
The BSCC formulated definitions are
effective immediately but are open to
comment the text following the
definition of "pathogen" contains details
of,the request for comments.
  Organisms meeting two different sets
of criteria are proposed. First are
organisms formed by deliberate
combination of genetic material from
sources in different genera. It w*s
recognized, however, that tn certain
precisely constructed "intergenenc
organisms" the genetic matenal is not
considered to pose an increased nsk to
human health or the environment: thus.
such combinations are excluded from
the definition. A detailed explanation of
the scientific basis for iheae exclusions
is found in the footnote after the
definition of pathogen. The BSCC
specifically requests comments on
whether also to consider for exclusion
those organisms that exchange ON \ b\.
known physiological processes, as
explained in the text immediately
following the definition of "mtersene' •
organism (new organism)."
   The second definition is "paihov°-.
This includes microorganisms that
belong to a pathogenic species or ir--
contain genetic material from sourc-
organisms that are pathogenic. In
certain  precisely constructed modi/
organisms, the genetic material fro-
pathogenic donor is not considered
pose an increased risk to human *••
or the environment and. therefor*
combinations ore excluded from "•
definition.
   The BSCC definitions of "inter?
organism (new organism)" and
-------
                      Federal Register /  Vol. 51.  No.  123 /  Thursday.  ]\me 26. 1986 t Notices
"pathogen7' describe the combinations
genetic material that would cause a
modified organism to come under
review. This does not mean to suggest
that the behavior of a genetically
manipulated organism exempted from
these definitions is wholly predictable
(since any biological organism is never
100% predictable), but  that the
probability of any incremental hazard
compared to the unmodified organism
host is low Also, this does not mean
that any product manufacture or
research experiment using an organism
exempted from the definition should be
conducted without adherence to proper
manufacturing standards or research
guidelines.
   C.-.en the statutory differences in the
lart* ;lial they administer, the agencies
adopted the principles underlying the
definitions In ways consistent with their
legislation. EPA. APHIS, and S&E are
using the definitions to identify levels of
review for microbial products within
their jurisdiction. EPA. APHIS. FDA.
S&E. and NSF are using the definitions
as factors to consider in the review of
products or experiments.
  The BSCC is attempting to define
what constitutes "release into the
environment" The BSCC is establishing
a working group on greenhouse
containment and small field trials in
order to develop scientific
recommendations. The concept of
"containment" has traditionally been
used to describe physical conditions
which severely limit release (for  •
example, a contained laboratory
fermentation facility). Containment can
also be "biologic" because the ability  of
an organism to reproduce, exchange
genetic information, or become
established can be effectively limited
biologically. Thus, the  BSCCs
exploration of the conditions that
constitute release into the environment
will consider circumstances of both
physical and biological containment for
particular organisms and the
circumstances of their release. While  the
concept of physical containment may
imply the high containment conditions
found in certain laboratories and
greenhouses,  in agricultural practice
many simpler effective barriers are
rountinely used: these include
microplots for soil bacteria and fungi.
paddocks for nomnfective animals,  and
removing or covering the reproductive
parts of plants and animals.
   Release into the environment, for the
time being, will have somewhat varying
definitions for the regulatory and
research review of the different
agencies. There may be minor
differences between agricultural and
nonagncultural approaches and
betweeen macro-and microorganisms.

Intergenenc Organism (New Organism)
  Those organisms deliberately formed to
contain an intergenenc combination of
genetic material: excluded are.orgamsmi that
have resulted from the addition of
intergenenc materials that is well-
charactenzed and contains only non-coding
regulatory regions such as operators.
promoters, origins of replication, terminators
and rbosome binding regions.
  "Well-characterized and contains only
non-coding regulatory regions" means thai
the producer of the microorganism can
document the following-
  a The exact nucleotide base sequence of
the regulator r»aion and any inserted
flanking nucleoudes:
  b The rpgulcwy "!gio" and any -sserted
flanking nucleotides do not code
independently for a protein, peptide of
functional UNA molecules:
  c The regulatory region solely controls the
activity of other sequences that code for
protein or peptide molecules or act as
recognition sites for the initiation of nucleic
acid or protein synthesis.

Pathogen
  A pathogen is a virus or microorganism
(including its viruses and plasmids. if any)
that has the ability to cause disease in other
living organisms (i.e.. humans, animals.
plants, microorganisms).
subiect to regulatory policies regarding
pathogens it
  a. The oucraofganism belongs to a
pathogenic species, according to sources
identified by the agency, or from information
known to the producer that the organism is a
pathogen: excepted an organisms belonging
to a strain used for laboratory research or
commercial purposes and generally
recognized as non-pathogenic according to
sources identified by a federal agency, or
information known to the producer and the
appropriate federal agency (an example of a
noopathogenic strain of a species which
contains pathogenic strains is Eschenctiia
call K-12: examples of nonpathogenic species
are Bacillia subtiNg. lactobaalau
actdohilut, and Soccharomyce» species): or
  b. The microorganism has been derived
form a pathogen or has been deliberately
engineered such that it contains genetic
material from a pathogenic organism as
defined in item a. above. Excepted an
genetically engineered organisms developed
by transferring a well-characterized, non-
coding regulatory region from a pathogenic
donor to a non-pathogenic recipient
  "Well-characterized, non-coding regulatory
region ' means that the producer of the
microorganism can document the following:
  aJThe exact nucleotide base sequence of
the regulatory region and any inserted
flanking nucleoudes:
  b. The regulatory region and any inserted
flanking nucleotides do not code
independently for a protein, peptide. or
functional UNA molecules, and.
  c. The regulatory region solely controls the
activity of other sequences that coda for
protein or peptide moldecules or act aa
recognition sites for the initiation of nucleic
acid or protein-aysthesis.
  This definition excludes organisms such as
competitors or colonizer* of the same
substrates, commensal or mutuahstic
microorganisms, or opportunistic pathogens

  The footnote contains the scientific
basis for exempting non-coding
regulatory regions from the definitions
of mtergenenc organisms and
pathogen.1

  1 The BSCC has based ihe exe-npuon of
mtergenenc transfer* of regulator) region] on their
lack of coding capacity for the production of
proteins peptide* or functional RS \ -uit i ~'es. li
hci been recommended by oth«r merrc"". if the
.grian"'": co"i."!ur:1y •'•::• •'•s-i :.*CJ'B ~c .-d •.$-»!
exemptions such at nbosomal proteins  nhosomal
RNAs and transfer RNAs The BSCC has chosen to
examine these suggestions m more detail during the
next few months. At the present ihe BSCC I'd)
excluded.
  l Origins of replications:
  2 RibosoRM binding sites
  3 Pro IRQ IBFK
  4 Operators, and.
  S Terminator*.
  The basis lor these exemptions is ss'
of these regulatory elements has no codii_
for the production of any gene product afl
does not promote the production of am
material. What these elements are responsible for -s
ihe initiation and modulation of nucieic ai.u
synthesis at lh*> specific region whet TKX.   :~«r
in ihe chromosome.
  Bacterial genes are pnaiel) resi.la.i-' .   - »
regulation w based on a sene* of rer.id •
elements. The pnnapal regulatory urn-  «
opera Operons ate controlled prtma-  .
exclusively, through the regulation of -
initiation of messenger RNA symhein
regulation is based on the mterac-mr
nucleotide sequence* in the DNA. if-*
which i* the sit* of UNA polymers"
the operator, which follows dosel) •
off^n awttdi-for the movement of "-*
into the structural gen* which folio* •
of the operator is to bind a cellular •
which w synthesized in response to
nutritional stimuli Terminator re*. • •
nudeoude sequence* which signai
of mRNA synthesis by the polymer. •
a signal for the dissociation of th>
the DNA
  Replication of DNA in every bi>
that has been examined is ininair
or group of sites in the diromoso-
have broad specificity and a ON *
the appropriate site will not be r>
which are critical to the initiation
known as origin* of replication  '
short nucleonde sequences whu-
sites for specific enzyme action
replication process For example
mammalian ONA to replicate in
associated with a bacterial ong
v.ee vena
  Ribosome binding tun are v
segments  al the beginning of mr
molecules which signal the ana.
for the initiation of protein sym
this role they are not translated
peptide being processed.
-------
23308
Federal Register  /  Vol. 51. No.  123 /  Thursday. |ane 26. 1986  /  Notice*
  The BSCC is requesting comments on
these definitions during the penod of
si ity days following the date of this
notice and specifically seeks comments
Addressing the following:
  1 The suitability and applicability of
 ppse definitions to applications
.r.volung release :n'o ihe environment.
conta ned industrial large-scale
ippiiuutions. foods/food additives.
iipjijs.  medical devices, and other
p'.'-stbie products.
  2 VV hi-iher combinations of genetic
  Mten.il from organisms that exchange
j\.\ b<. known physiological processes
,.-.odM •:.' -\t '-dprl fnim the definition
i.f-nt-.  -  -«•-.  jrgamsms: i.e. should
T-uan- JT-- '>.e excluded which contain
.r:jrgcr.i'r:c .M.muinations of certain
suucifiea rDNA molecules that consist
entirely of ONA segments from different
j«nera that exchange DNA by known
pnx siologH-ai processes? As certain
rDNA organisms are exempted under
section 111-0-4 of the NIH guidelines.
the question  was raised whether  these
organisms when used in the
environment should be similarly
exempted from federal product review.
This exemption would not however.
exclude from review such "natural
exchangers"  thai are also pathogens or
plant pest*. In the event that the
exclusion of such different species that
exchange DNA by known physiological
processes u accepted as appropriate, a
list of such species combinations that
has been maintained and updated by Ihe
Office of Recombinant ONA Activities
of the National Institutes of Health wOT
be updated, in light of environmental
use.
  3. What are the moat appropriate
definitions of "release into the
environment" for macro- and
microorganisms.

E. International Aspects

  The United States seeks to promote
international scientific cooperation and
.inderstanding of scientific
considerations in biotechnology on a
range of technical matters. These
a- tivities add to scientific knowledge
nnd ultimately contribute to protection
of health and '.he environment.
  The United States also seeks to
ipduce barriers to international trade.
U S. agencies apply the same regulation
snd approval procedures on domestic
and foreign biotechnolcgical products.
We are seeking recognition among
nations of the need to harmonize, to the
maximum extent possible, national
regulatory oversight activities
concerning biotechnology. Barriers to
trade in biotechnological products
should be avoided as nations join
                    together in working toward this mutual
                    goal.
                      The U.S. agencies that have published
                    separate policy statements as part of
                    this notice are committed to the policy
                    described in this section on
                    international harmonization and have
                    incorporated by reference the language
                    in this International Aspects section as
                    part of their respective agency policy
                    statements.

                    Organization for Economic Cooperation
                    and Development (OECD)

                      The approach of the comprehensive
                    framework contained m this notice
                    takes into account, inter alia, the broad
                    goals described  by an Ad Hoc Croup of
                    Government Experts convened by
                    OECD in their recent report entitled.
                    ' Recombinant DNA Safety
                    Considerations.  Safety Considerations
                    for Industrial. Agricultural and
                    Environmental Applications of
                    Organisms Derived by Recombinant
                    DNA  Techniques." Th* United Stales is
                    pleased to have  had the opportunity for
                    its experts to work with those of other
                    governments in the preparation of  this
                    report The report includes the following
                    concepts:
                    Summary of Ma/or Points
                      Recombinant DNA techniques have opened
                    up new sad promising possibilities in a wide
                    range of applications and can be expected to
                    bring considerable benefits to "-tiiniiH They
                    contribute in several ways to the
                    improvement of human health and the  extent
                    of this contribution is expected to increase
                    significantly in the near future.
                      The vast majority of industrial rDNA large-
                    scale applications will use organisms of
                    intrinsically tow risk which warrant only
                    miHI 1MB CQBtsnBfflaVIlt* GOOd IBdUCflrteu  LaUVO"
                    Scale Practice (GOSP).
                      When a is necessary to use rDNA
                    organisms of hajher nak. adrHHenal criteria
                    for nsk assessment can be identified and
                    furthermore, the tscssMieay ai physical
                    containment is w»
encouraged in large-scale industrial
applications requiring physical con-

///. Recommendation* Specific for
£.1 vinnmentaJ and Agricultural At.-.
   \ Considerable data on the eavir
and human health affects of living
-------
                    Federal  Register / Vol. 5*. No. 123 / Thursday. June  26.  1988 f Notices'
                                                                      29309
exist and should be used to guide risk
assessments
  2 It is important to evaluate rONA
modified organisms for potential risk, pnor to
applications in agricultural and the
environment However, the development of
general international guidelines governing
sach appiirations is premature at this time
•\n ..i that every case will require review by
a national or other authority since various
c'dsses of proposals may be excluded.
  3 Development of organisms for
ag"cUi'jidl or environmental applications
should be conducted in a stepwise fashion.
moving, where aooropnate. from the
laboratory, to the growth chamber and
greenhouse, to limited Held testing and
finally,  to large-scale field testing.
  4 Further research to improve the
prediction, evaluation, and monitoring of the
outcome of application* of rONA organisms
should be encouraged.

DEPARTMENT OF HEALTH AND .
HUMAN SERVICES
Food and Dmg Administration
(Docket No. 84N-0431)

Statement of Policy for Regulating
Biotechnology Products

AOINCV: Food and Drug Administration.
ACTION: Final policy statement for
regulating biotechnology products.	

SUMMARY: In the Federal Register of
December 31.1984 (43 FR 50878). the
Food and Drug Administration (FDA)
published a policy statement for
regulating biotechnology products. The
policy statement was part of a larger
document that included an index of U.S.
laws related to biotechnology, a
description of the policies of the major
regulatory agencies that are involved in
reviewing the products of biotechnology.
a descnption of a proposed scientific
advisory mechanism for assessment of
biotechnology issues, and an
explanation of how the activities of the
Federal agencies involving
biotechnology will be coordinated. Of
the comments FDA received on the
policy statement most favored the
policy statement: some requested further
clarification and guidance. The current
action constitutes FDA's final policy
statement which has been revised in
response to the comments.
ADDRESS: Written comments should be
submitted to the Dockets Management
Branch (HFA-305). Food and Drug
Administration. Room 4-62.5600 Fishers
Ldne. Rockville. MD 20857.
FOR FURTHER INFORMATION CONTACT!
Dr Mary Ann Danello (HF-5). Food and
Drug Administration. Room 14-90. 5600
Fishers Lane. Rockville. MD 20857. 301-
443-4630.
SUPPLEMENTARY INFORMATION: FDA's
policy statement of December 31.1984
stated the FDA regulation must be
based on the rational and scientific
evaluation of products, and not on a
priori assumptions about certain
processes. Accordingly. FDA's
administrative review of products.
including those thai employ specialized"
biotechnological techniques, is
conducted in the light of the intended
use of a product on a case-by-case
basis  FDA believes the agency need not
establish new administrative procedures
to deal with generic concerns about
biotechnology.
  These views were supported by the
majority of comments  received in
response to FDA's notice. Thirty-four
comments were received,  with 12 from
manufacturers of regulated products. 18
from associations and universities, and
6 from individuals. A summary of the
comments and the agency's response to
them follow:
  1. Many commenters urged the agency
to publish additional "Points to
Consider" documents to provide further
guidance for biotechnology product
applicants. These commenters
specifically requested guidance in the
area of animal drugs (especially protein
drugs) and human foods and food
additives.
  FDA agrees that "Points to Consider"
documents provide useful guidance.
especially in areas involving new
biotechnology, and will consider
developing these documents where
appropriate.
  2. Related comments raised questions
on FDA's general requirements for
approving biotechnology products that
are animal drugs, human foods, or food
additives.
  In response to these comments. FDA
has amended the animal drug section
("General Requirements for Animal
Food Additives  and Drugs") to be more
informative and has added a new
section concerning its policies on human
foods and food additives (see "General
Requirements for Human  Foods and
Food Additives").
  3. Many comments questioned the
need for new or supplemental marketing
applications for biotechnology products
that are identical to products derived
from conventional technology.
  The agency has re-examined this issue
and continues to believe that, as a
general principle, new marketing
applications will be required for most
products manufactured using new
biotechnology For example, use of
recombmant DNA (rDNA) technology
has the potential to lead to new
structural features in the product, result
in product micro-heterogeneity, or
introduce new contaminants (e.g.
associated with new cell substrates).
each of which may affect the safety
efficacy and stability of the product.
Because of potential differences in  the
products resulting from use of
recombmant DN'A technology  the
resulting products may be  new'
products requiring separate approval
under the applicable statutory
provisions However, each case vv-ll be
examined separately to detennu.e -he
appropriate information ;o be suorr.itteo
In some instances complete new
applications may not be required  For
example, the sponsor of a
conventionally produced animal drug
product who manufactures an identical
or virtually identical product using
biotechnology may be required to
submit only a supplemental application.
However, if the animal drug product-
manufactured using  biotechnology
differs significantly from the prodd
manufactured by conventional
processes, a complete original
application would be required The
agency believes that each product  must
undergo adequate and appropriate
testing and review to ensure that it is
safe and effective regardless of the
technology employed. Sponsors are
urged to communicate with FDA to
establish the scope of information
required for products of biotechnolcgv
  4. Many comments questioned the
need for the proposed review
mechanism by a Biotechnology Science
Board (BSB). These comments stated
that the additional layer of review
would cause delays in the product
approval process.
  A notice published in the Federal
Register of November 14 1985 (50 FR
47174) discussed the establishment of
the Biotechnology Science Coordira" -i
Committee (BSCC) within the Fedc--'.
Coordinating Council for Science.
Engineering and Technology That
notice addressed vanous criticisms
the BSB. FDA believes that the neu
BSCC will facilitate sharing of
biotechnology information among
agencies and will not delay agent".
reviews of product applications
  In view of the foregoing. FDA >
policy statement for regulating
biotechnology products reads a<
follows:
-------
-------
PMN AND PMN EXEMPTION CHECKLIST
N/A
























Yes
























No















•









PMN Submission
90-day Review Date and Notice of Commencement
Chemical Identification and Structure
Impurities, byproducts
Proposed Volume of production
Proposed categories of use
Process description
Worker exposure
Release and disposal information
Health and environmental effects data
Polltuion prevention and recycling
Research & Development (R&D) Exemption
Company Policy
Technically qualified individual
Recordkeeping and notification
Test Marketing Exemption
Period of applicability
Health and environmental effects testing data
Chemical identification and structure

Maximum quantity of chemical substance and number of customers
Maximum number of persons exposed and duration and routes of
exposure
Description of test-marketing activity
Additional EPA-imposed restrictions
-
-------
PMN AND PMN EXEMPTION (continued)
N/A



























Yes



























No




























Low Volume Exemption (LVE)
Manufacturer's name and technical contact
Chemical identification and structure
Description of use
Site of manufacture
Heal and environmental effects testing data
Customer notification
Exposure controls
Polymer Exemption (PE)
Manufacturer's name and technical contact
Site of manufacture
Chemical identification and structure
Impurity information
Production volume
Category of use
Health and environmental effects testing data
Instant Film Chemical Exemption (IFCE)
Condition of manufacture and processing in the special production
area (SPA)
Conditions of processing outside the SPA
Environmental release and waste treatment
Chemical identification and structure
Physical-chemical properties
Byproducts
Production volume
Health and environmental effects testing data
Identity of the article
Release to water
-------
SECTION 5
-------
SECTION 8(a) PAiR AND IUR REPORTS
N/A

























Yes

























No
.

























PAIR report
Quantity of chemical manufactured or imported for sale or use
Qauntity lost to the environment and in wastes
Manufacturing processes and worker exposure
On-site use of chemical as a reactant
On-site nonreactant use of the chemical
On-site preparation of products
Manufacturer's products
Customers' uses and products
Trade names
Customers' process categories
Research & Development (RAD) exemption
Small quantity exemption
Small manufacturer exemption
Chemical manufactured as non-Isolated Intermediate, an impurity, or
byproduct
Inventory Update Rule (IUR) report
Production volume
Plant site
Site-limited status
Manufactured or imported chemical is a polymer, inorganic
substance, microorganism, or naturally-occurring substance
Not manufactured in reponable quantities
Small manufacturer exemption
Research & Development (R&D) exemption
Chemical imported as part of an article

-------
SECTIONS 8(c), 8(d), and 8(e)
N/A














Yes














No















Section 8(c): AllegaUons of Significant Adverse Human Health or
Environmental Effects
Company awareness of requirements
Allegation records not kept as required*-
No allegations on file
Records not retained for the required period of time
Section 8(d): Health and Safety Studies
Company awareness of requirements
Health and safety studies information inaccurate or incomplete
Reports not submitted
Section 8(e): Notification of Substantial Risks
Company awareness
Substantial risk information inaccurate, incomplete, or late
Substantial risk information not reported

-------