U.S. Environmental Protection Agency

Office of Enforcement

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT AND COMPLIANCE MONITORING
EPA-330/9-88-001
TSCA SECTION 5 AND 8 INSPECTION
STANDARD OPERATING PROCEDURES
May 1988
Dean F. Hill
Diane Bradway
Peter Gee
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Denver, Colorado

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CONTENTS
I. INTRODUCTION	1-1
II GLOSSARY OF TERMS AND ACRONYMS:
TOXIC SUBSTANCES CONTROL ACT	11-1
III.	TARGET SELECTION FOR FISCAL YEAR 1988 TSCA SECTION 5/8
AND GLP INSPECTION PROGRAMS	111-1
A.	INTRODUCTION	111-1
B.	TSCA § 5/8 INSPECTION SCHEDULING	III-2
C.	TARGETING PROCESS	III-5
D.	INSPECTION ACCOUNTING	III-6
IV.	PLANNING AND ARRANGING AN INSPECTION	IV-1
A.	INTRODUCTION	IV-1
B.	PLANNING	IV-1
C.	ARRANGEMENT OF A SPECIFIC INSPECTION	IV-4
V.	INSPECTION MANAGEMENT	V-1
A.	INTRODUCTION	V-1
B.	ADMINISTRATION	V-1
C.	ORGANIZATION AND NATURE OF FACILITY	V-6
VI.	TSCA SECTION 5 INSPECTIONS	VI-1
A.	INTRODUCTION	VI-1
B.	RESEARCH AND DEVELOPMENT (R&D)
(40CFR PART 720.36)	VI-1
C.	SPECIFIC PRE MANUFACTURE NOTIFICATION (PMN)	VI-6
D.	GENERAL INVENTORY COMPLIANCE	VI-16
E.	SECTION 5(e)/5(f) ORDER	VI-19
F.	TEST MARKETING EXEMPTION (TME)	VI-26
G.	LOW VOLUME, POLYMER AND FAST FILM EXEMPTION	VI-30
H.	POLYMER EXEMPTION (PE)	VI-30
I.	SIGNIFICANT NEW USE RULE (SNUR)	VI-31
VII.	TSCA SECTION 8 INSPECTIONS	VII-1
A.	BACKGROUND	VII-1
B.	TSCA SECTION 8(a) LEVEL (A) PAIR REPORT
COMPLIANCE	VII-1
C.	TSCA SECTION 8(b) INSPECTION	VII-5

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CONTENTS (cont.)
D.	TSCA SECTION 8(c) INSPECTION	VII-5
E.	TSCA SECTION 8(d) REPORTING	VII-10
F.	TSCA SECTION 8(e) SUBSTANTIAL RISK REPORTING	VII-11
VIII.	INSPECTION REPORT PREPARATION	VIII-1
A.	INTRODUCTION	VIII-1
B.	TIMELINESS	VIII-1
C.	REPORT FORMAT	VIII-1
D.	FORMAT - WORKSHEET	Vlll-2
E.	FORMAT - FULL NARRATIVE REPORT	Vlll-2
F.	REPORT REVIEW	VIII-10
G.	SECURITY AND CUSTODY	VIII-10
H.	EDITORIAL GUIDELINES	VIII-11
IX.	COLLECTION OF EVIDENCE	IX-1
A.	BACKGROUND	IX-1
B.	FIELD NOTES	IX-1
C.	RECORDS	IX-2
D.	PHOTOGRAPHS	IX-4
E.	PHYSICAL SAMPLES	IX-5
X.	RECORDKEEPING AND DATABASES	X-1
A.	RECORDKEEPING	X-1
B.	ORGANIZATION OF TSCA CBI FILES	X-6
C.	INFORMATION SOURCES	X-7
XI.	TRAINING	XI-1
A.	GS 5/7 ENTRY LEVEL	XI-1
B.	GS 9/11 JOURNEYMAN LEVEL	XI-2
C.	GS 12 SENIOR SPECIALIST	XI-3
REFERENCES
li

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CONTENTS (cont.)
APPENDICES
A	§ 5 ENFORCEMENT RESPONSE POLICY
B	§ 8, § 12 AND § 13 ENFORCEMENT RESPONSE POLICY
C	PMNFORM
D	GLOVE TESTING GUIDELINES
E	EPA HQ § 5 INSPECTION GUIDELINES
F	EPA HQ § 8(a) LEVEL A INSPECTION GUIDELINES
G	EPA HQ § 8(b) INVENTORY UPDATE REPORTING RULE
INSPECTION GUIDELINES
H	EPA HQ § 8(c) INSPECTION GUIDELINES
I	EPA HQ § 8(d) INSPECTION GUIDELINES
J	EPA HQ § 8(e) INSPECTION GUIDELINES
K	§ 8(e) INTERPRETIVE STATEMENT
L	NEIC REPORT WORKSHEET
FIGURES
IV-1 Fourth Quarter Targeting Region IX, Los Angeles, CA (Example)	IV-2
IV-2	Tracking Sheet	IV-5
IV-3	Notification Letter (Example)	IV-16
V-1	TSCA Notice of Inspection Form	V-3
V-2	TSCA Inspection Confidentiality Notice Form	V-5
V-3	TSCA Receipt for Samples and Documents Form	V-7
V-4	TSCA Declaration of Confidential Business Information Form	V-8
VI-1	PMN Status Update Report	VI-10
VI-2	PMN Federal Register Status Report	VM1
Vl-3	Notice of Commencement Listing	VM 2
Vl-4	IMD Inventory Search Form	VM8
VIII-1	Example of Title Page	VIII-3
IX-1	Document Stamp	IX-3
X-1	CICIS Printout Example	X-9
X-2	D&B Short Form	X-10
TABLES
111-1 Inspection Distribution By Region	111-1
VI-1 Recordkeeping Requirements	VI-5
VI-2 Requirements For Notification of Risks	VI-6
iii

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1-1
I. INTRODUCTION
On October 1, 1985, the National Enforcement Investigations Center
(NEIC) within the U.S. EPA Office of Enforcement and Compliance Monitoring
(OECM) was given the responsibility for conducting Toxic Substances Control
Act (TSCA) inspections to verify industry compliance with Sections 5 and 8
(TSCA § 5/8) in Regions I, IV and VI through X. NEIC was also formally given
responsibility for conducting Good Laboratory Practice (GLP) Standards and
Data Audit inspections in Regions VI through X for TSCA (Sections 4 and 5)
and Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (Sections 3 and
8). These programs were specifically delegated to the Pesticides and Toxic
Substances (P&TS) Branch within Laboratory Services of NEIC. In addition to
these delegated responsibilities, the Branch has been called upon to conduct
other special TSCA and FIFRA inspections or investigations, both domestically
and in other countries. Operating guidance for the conduct of GLP/Data Audit
inspections will be provided separately due to the dissimilarity between the GLP
and TSCA § 5/8 programs.
The guidance given in these Standard Operating Procedures (SOPs) is
intended to be followed, as necessary, when planning and conducting TSCA
§ 5/8 inspections. These procedures are also intended to supplement, not
replace, other Agency policy and guidance procedures, particularly as provided
in; (1) the U.S. EPA TSCA Inspection Manual,' (2) the NEIC Policies and
Procedures Manual,^ (3) Office of Compliance Monitoring (OCM) inspection
guidelines (see Appendices) and, (4) other applicable Agency directives.
This document was conceived to be dynamic in nature and, thus, subject
to periodic revision. Suggested revisions, additions and corrections should be
submitted to D. F. Hill at earliest opportunity.

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11-1
II. GLOSSARY OF TERMS AND ACRONYMS: TOXIC SUBSTANCES
CONTROL ACT*
TSCA Chemicals: The term "TSCA Chemical" does not include pesticides,
pharmaceuticals, controlled drugs, cosmetics, radionu-
clides, firearms, etc., by definition.
PMN:	Premanufacture Notification to the U.S. EPA is required for
commercial manufacture or import of all "new" TSCA
chemicals, [i.e., those not listed on the §8(b) existing
chemical inventory or covered by other TSCA exemptions
(40 CFR Part 720)]. Designated in Federal Register by a "P"
listing.
SNUR:	Significant New Use Rule requires subsequent notification
to EPA when: (1) manufacture/usage/exposure changes for
an existing chemical, or (2) other manufacturers and/or
processors handle a new chemical (40 CFR Part 721).
NOC:	Notice of Commencement to the Agency is required when
(or within 30 days) commercial manufacture or import
begins (after PMN review period has expired) (40 CFR Part
720.102).
TME:	Test Marketing Exemption - an exemption from the PMN
requirement to evaluate competitive market compatibility of
a chemical. Can be obtained upon application to and
approval by EPA - usually subject to specific restrictions
(40 CFR Part 720.38). Designated in Federal Register by a
"T" listing.
LVE:	I nw Volume Exemption - exemption (by application only)
from PMN requirement for new TSCA chemicals produced
Originally prepared by C. Aschwanden, NEIC Enforcement Specialists Office

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11-2
or imported at less then 1,000 kg/year (40 CFR Part
723.50). Designated in Federal Register by an "L" listing.
PE:
Polymer Exemption: - exemption (by application only) from
PMN requirement for certain polymers (or classes of
polymers) (40 CFR Part 723.250). Designated in Federal
Register by a "Y" listing.
CBI:
Confidential Business Information - information protected
under § 14 of TSCA.
R&D Exemption:
SECTION 5(e)
Order:
Research and Development - automatic exemption which
does not require Agency review or approval. Does require
hazard evaluation, recordkeeping and customer
notification.
An administrative order, rule or injunction prohibiting, limit-
ing or otherwise placing restrictions on the manufacture,
processing, distribution, use and/or disposal of a chemical
for which a PMN was required, because there was insuffi-
cient information to permit full Agency evaluation.
SECTION 5(f) An administrative order, rule or injunction prohibiting/
Order:	limiting the manufacture, import, processing, etc., of a
chemical for which a PMN was required because there was
a reasonable basis to conclude that such activities pre-
sented an unreasonable risk to health/environment.
"Bona fide'
Inquiry:
Official inquiry to the Agency by a manufacturer or importer
that intends to produce, import or process a specific
chemical to determine whether it is on the confidential
portion of the TSCA § 8(b) inventory.
PAIR:
Preliminary Assessment Information Rule - Promulgated
under § 8(a) Level A - requires reporting to Agency of

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11-3
production, use(s) and exposure of specific chemicals or
classes of chemicals.
CAIR:	Comprehensive Assessment Information Rule - will
eventually replace the PAIR rule. Will cover in more detail
the production, use, exposure and disposition of designated
chemicals. May also apply to processors and users.
ITC:	Interagency Testing Committee - recommends additional
chemicals to the PAIR rule as well as to the § 8(d) rule. ITC
is established under § 4(e) of TSCA. The ITC may also
recommend chemicals for inclusion in testing rules under
§ 4(a).
IUR:
Inventory Update Rule - requires production volume
reporting to EPA of all large volume organics during a
company's complete fiscal year prior to August 1986.
Requires similar reporting every 4 years (40 CFR 710.23).
SIC Code
Standard Industrial Classification - list of codes published
by Department of Commerce for different types of
commercial enterprises.
SECTION 8(a)
Level A
Inspection:
An inspection to determine compliance with the PAIR rule
(40 CFR Part 712).
SECTION 8(b) Inventory compiled by EPA of all commercial chemicals that
Inventory:	were manufactured, imported or processed in the U.S. in
the calendar year 1977. Chemicals for which a PMN is
approved are added to the inventory when manufacturing
or import commences (i.e., upon receipt of an NOG). A
major updating of the inventory (IUR) was undertaken in
1986.

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11-4
CASR No.:
Chemical Abstracts Service Registry Number
SECTION 8(c)
Inspection:
An inspection to determine whether a manufacturer,
processor, etc., has kept required records concerning
allegations of previously unknown significant adverss
reactions to health or environment (40 CFR Part 717).
SECTION 8(d)
Inspection:
An inspection to determine compliance with rules requiring
submission of previously unpublished health and safety
studies for chemicals or classes of chemicals designated by
the Agency or the ITC (40 CFR Part 716).
SECTION 8(e)
Inspection:
An inspection to determine whether the manufacturer,
processor, etc., has properly notified EPA (within 15 days of
knowledge) regarding chemicals that present a substantial
risk to health or environment. Emergency substantial risk
incidents also require immediate notification (via
telephone). Federal Register 43. 11110 (1978)1.

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111-1
TARGET SELECTION FOR FISCAL YEAR 1988 TSCA SECTION 5/8
INSPECTION PROGRAMS
INTRODUCTION
This section defines selection of NEIC inspection sites for the Toxic
Substance Control Act TSCA § 5/8 enforcement program so as to meet
the requirements of a Neutral Administrative Inspection Scheme (NAIS).
NEIC has received delegated authority to conduct all TSCA § 5/8
inspections in EPA Regions I, IV and VI through X. Inspection program
overview and policy guidance are provided by the Office of Compliance
Monitoring (OCM) within the Office of Pesticides and Toxic Substances
(OPTS). Included within the OCM guidance are the annual inspection
goals categorized by Regional distribution as shown in Table 111-1.
Figures in this table are based on Fiscal Year 1986 distribution. The total
number o1 inspections varies from fiscal year to fiscal year based on
available resources and other priorities.
Table 111-1
INSPECTION DISTRIBUTION
BY REGION

Percent of

Total
Region
Inspections
I
12
IV
25
VI
30
VII
11
VIII
5
IX
13
X
4
Total
100%
In addition to the TSCA § 5/8 inspection program, NEIC also has
responsibility for TSCA and FIFRA Good Laboratory Practice (GLP)
Standards inspections of testing laboratories in Regions VI through X.

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111-2
Most laboratories that provide regulatory testing are known to the Agency
and are scheduled by OCM for inspection approximately every 15 to 18
months. These inspections primarily involve study audits, but also may
include full GLP evaluations of ongoing laboratory operations. Because
of the prescribed schedule and limited number of testing laboratories
subject to GLP regulations, the remainder of this chapter is limited to
documentation of TSCA § 5/8 inspection targeting.
B. TSCA SECTION 5/8 INSPECTION SCHEDULING
Three categories of potential targets have been established, from which
site selections for TSCA § 5/8 inspections in the designated NEIC
regions will be identified:
1.	Firms of which 100% are inspected within a given 2-year
period.
2.	Firms which have a high probability of being inspected in a
2-year period.
3.	Remainder of existing chemical firms which have a
relatively low probability of inspection in a given 2-year
period.
Although highly desirable and will remain NEIC's goal, inspecting all
existing chemical facilities every 2 years will be difficult to achieve due to
geographical constraints, resource considerations and incomplete
knowledge of all chemical manufacturing, importing and processing
firms.
The three categories are further defined as follows:

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111-3
Category 1
All firms to be inspected within 2 years of knowledge (highest orioriM
As they become known, all chemical manufacturing, importing and
processing facilities in NEIC designated regions in the following groups
will be targeted for inspection within the following 2-calendar years:
Firms that are subjects of tips/complaints or referrals relative
to any potential TSCA § 4, 5 or 8 violation or followup
Firms subject to TSCA § 5(e) or 5(f) orders, rules or
injunctions for which notices of commencement (NOCs)
have been submitted
Firms subject to Significant New Use Rules (SNURs)
Those subject to followup inspections for previous viola-
tions, commercial use investigations or other enforcement
related reasons.
Category 2
Geographically selected firms that will be inspected to the degree
possible within 2 years of knowledge I mid-level priority^
Based on the location of firms identified in Category 1, the following
criteria will be utilized to select additional targets in the same general
geographical area(s):
Submitters of recently approved PMNs, TMEs, LVEs and
PEs
•	Submitters of recent bona fide inquiries that resulted in a
negative § 8(b) Inventory finding
Submitters of TSCA § 8(c) and 8(e) reports
•	Submitters of withdrawn PMNs, TMEs, LVEs and PEs
Firms that have submitted TSCA § 8(d) and 8(a) Level A
PAIR reports within the past eight reporting periods

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111-4
Potential PMN targets will be prioritized based on the number of PMNs
submitted within the past 2 years, and bona fide targets will be based on
the total number of inquiries for which there were no PMN followup
submittals. The proportion of inspection sites in the first two categories
will be targeted to achieve the overall regional target distributions
provided by OCM (see Table 111-1). Priority will also be given to known
chemical importers and specialty chemical producers; otherwise firms
will be selected randomly.
Category 3
Randomly selected non-submittin? firms flowest priority!
If enough inspections cannot be targeted from facilities in Categories 1
and 2 for a given geographical area, additional sites will be selected from
other sources, including those listed below. In general, these sites will
not have made submissions to the Agency, as defined for Categories 1
and 2 and will not be the subject of tips, complaints or referrals. Priority
will be given to those known to be importers of chemicals and specialty
chemical manufacturers, otherwise the firms will be selected randomly.
Sources
Chemical Producers Directory (latest Edition)
Dun & Bradstreet (chemical SIC codes)
Yellow Pages (telephone directories and electronic data
bases)
Trade Journal advertisers
Observations and referrals
Original and updated § 8(b) Inventory submitters not classi-
fied in Categories 1 and 2
Although these databases, which include many current nonsubmitters to
the Agency, are incomplete and are being continually developed, plans
exist to establish an automated database of all firms subject to inspection
from which random selection can be made for any geographical area,
priority being given to importers, followed by specialty chemical
manufacturers, other producers and processors, respectively.

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111-5
C. TARGETING PROCESS
The following documents and/or resources are to be utilized by the
senior TSCA § 5/8 staff to select prospective targets to meet the NAIS, as
previously discussed.
Tips/complaints/referrals: Derive from Office of Toxic
Substances (OTS), Office of Compliance Monitoring (OCM),
EPA Regional Offices, private citizens, industry competitors
and other Federal agencies
§ 5(e)/5(f): All TSCA § 5(e)/5(f) orders with a notice of
commencement (NOC) filed are to be forwarded automati-
cally by OCM to NEIC.
SNURs: All SNUR submittals or Agency referrals are to be
forwarded automatically to NEIC by OCM.
PMNs, TMEs, LVEs, PEs and bona fides: These will be
selected from the quarterly computer summary and
requested as hard copies from the OTS Information
Management Division (IMD) via OCM. At least 6 weeks is to
be expected for turn-around time on routine requests.
* PAIR reports: These also will be selected from the § 8(a)
Level A computer summaries and hard copies will be
requested on a quarterly basis at the beginning of each
quarter; 6 weeks will be allowed for turn-around time from
IMD on routine requests.
Withdrawn PMNs, TMEs, LVEs and PEs: These will be
selected and hard copies requested in similar fashion to
other PMNs, etc.

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INSPECTION ACCOUNTING
(to be completed)

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IV-1
IV. PLANNING AND ARRANGING INSPECTIONS
A.	INTRODUCTION
This section is intended to provide guidance to the inspector so he or she
can adequately plan and arrange for a routine TSCA § 5/8 inspection.
Deviations and added factors must be considered inherent for non-
routine and priority inspections and, although some direction has been
provided in these guidelines, professional judgement, supervisory
direction and/or legal advice (from the NEIC Enforcement Specialist
Office) may be necessary.
B.	PLANNING
Based on the targeting mechanism given in Chapter III, Neutral
Administrative Inspection Scheme (NAIS), a number of potential
inspection sites from a designated geographical area will have been
identified. Normally, a number of geographical centers will be chosen by
the senior staff at the beginning of each quarter which reflect all available
Category I sites in the NAIS. Adjustments to this schedule will be made
as new or changing priorities emerge.
The "Targeting Sheet" (an example is given in Figure IV-1) should
indicate a number of the known TSCA related firms in an area, based on
the NAIS priority order. All the "tips/complaints", referrals, § 5(e)/5(f)
Orders with NOCs, and suspect § 8(a) Level A nonsubmitters are listed
first, followed by PMN, § 8(a) Level A § 8(e) and TME, bona-fide, LVE
and PE submitters. Other firms with no known submittals will be termed
"General Inventory" and listed last. The Targeting Sheet will also identify
the available information for the site and the CBI numerical file
established by the Document Control Officer for the site. Normally any
missing information will have already been requested from OTS (via
OCM); however, since turn-around times for requests have typically been
2 to 3 months and the fact that some documents appear to be
nonrecoverable, necessary copies of all documents submitted to OTS by
the prospective firms may not be available for review prior to the

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IV-2
inspection. The inspector will need to assure that copies of such
documents are made available by the facility for review onsite (see
Section C, "Arrangement of a Specific Inspection"). The inspector must
keep in mind that some available documents may be misleading or
nonapplicable, particularly PMNs that were identified by the submitting
location {often the corporate or environmental affairs office). This may
not be the product development or production site. Finally, the inspector
should keep in mind that the NEIC database may be incomplete in that
there may be additional submittals, § 5(e) orders, etc., for a plant site, of
which NEIC is unaware, and which the inspector should document onsite
to the degree possible.
Figure IV-1
FOURTH QUARTER TARGETING REGION IX
Los Angeles, California
(Example Only)
Company
Inspection Type
File No.
Benzene Rings
Oxnard, CA 90990
Tip/complaint (PMN)
208
Mom's Ethyl, Inc.
Los Angeles, CA 91234
Region 5 Referral (PMN)
55
Big Daddy Paints
Poppyville, CA 90999
PMNs (7)
§ 8(a) Level A (2)
§ 8(e) LVE (4)
99
Good News Vapors
Tantamount, CA 99445
Bona fides (6)
71
LSD Dimensions
Learyville, CA 99880
§ 8(a) Level A (1)

Paint and Faint
Toluene, CA 99884
General Inventory

Kryptonite Novelties
ClarKent, CA 98765
General Inventory

Iguana Guano Ltd.
Aromaton, CA 99887
General Inventory

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IV-3
In addition to obtaining copies of available company documents (hard
copy or microfische) from the CBI files, the inspector will need to obtain
and review the following data files:
Chemicals in Commerce Information System (CICIS^
Report - Available for most chemical manufacturers upon
request from the Information Services Branch, NEIC.
This report or printout, if available, represents the plant
site's 1977 TSCA § 8(b) open (non-CBI) inventory listing. It
is useful for establishing the general type, total number and
associated volumes of produced chemicals. The CICIS
report will also allow quick accounting of many of the firm's
produced chemicals when checking their general
production inventory. Not all plant sites will have a CICIS
report and some facilities may have been operating under a
different company name in 1977. Major organic chemical
producers were required to update their inventory data in
1986 as part of the Inventory Update Rules (IUR).
Dun and Bradstreet (D&B) Report ¦ Available upon request
from the Information Services Branch, NEIC.
This report exists in several versions, designated the "Site
Report" and the "Corporate Report." The shorter Site Report
is usually adequate for most TSCA inspection purposes.
This report is usually current, thus an available printout is a
good indication that the firm is in business and that the plant
site is active. A manager or other senior level official will
also be identified with a telephone number.
Previous Inspection Reports - Available from NEIC files or
EPA regional office, as appropriate. FIFRA and TSCA
Enforcement System (FATES) or equivalent database files
should be reviewed to ascertain whether or not a plant has
been previously inspected by an EPA regional office.

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IV-4
C. ARRANGEMENT OF A SPECIFIC ^SPECTION
The arranging of a specific inspection is a critical phase of the overall
inspection process; diligence and attention to details at this stage will not
only minimize possible misunderstandings by the inspected firm, but also
provide assurance of timely and complete review (and collection, if
necessary) of company records necessary to achieve the purpose(s) of
the inspection. The guidance given in this section is intended to reflect a
typical inspection. Additional factors or assistance from senior staff may
be necessary for nonroutine or priority inspections.
Normally the targeted firm will be contacted by telephone approximately
2 weeks ahead of the proposed inspection date. This timeframe has
been established for the sake of consistency and to assure availability of
facility personnel and records. A shorter time or no advance notice may
be warranted for certain high-priority inspections.
The determination of the correct or appropriate person to contact at the
facility to be inspected may be difficult in some cases; however, a senior
level person such as Plant Manager, Regulatory Affairs Manager,
Environmental Affairs Officer, Laboratory Director or other equivalent
level official will normally serve as an initial contact for the inspection. An
appropnate contact, or at least a good first lead, may be provided in the
PMN, TME, PAIR submittal or other available Agency-submitted
document. The D&B report also will usually provide the name (and
telephone number) of the senior person in charge of a listed facility. If all
else fails, it may be necessary to contact Directory Assistance for a
telephone number and, after calling the facility, the inspector should ask
to speak to the person in charge. Occasionally a targeted firm may be
found to have gone out of business or have significantly changed
operations. In this event, a Tracking Sheet [Figure 1V-2] should still be
filled out and returned to the program supervisor with an explanation of
the circumstances. The program supervisor will assure that the
information is properly recorded into the inspection tracking system.

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IV-5
Figure 1V-2
TRACKING SHEET
TSCA Section 5/8 Inspection
TRACKING SHEET
Inatrucclons
1.	Ccmplece Part A
2.	S\±nLC to the DCO the week prior to your Inspection
recurred to you with your inspection foraw.)
3.	When the Inapectloi Is canpleted. fill out Part B.
4.	Return cracking sheet to the 000.
PART A
INSPECTOR
catPAW 	telep-cne.	/_
aEORESS-
£7 Headquarters £1 Manufacturing £7 Processing /J Importing fj R&D
Date of Contact 	
Dace Lecter Mailed 		
Date(s) of Inspection 	
Request for Inspection Materials
Inspection Notebooks '1 2 3 4 5 6 	 | j_~7 Canera £1 TSCA Scarp
Inspection Forra Sees 1 2 3 4 5 6 		 | Saspllng Equipment
PART B
T/C: Yes	No
5e/5£: 1 2 3 _
WE. 12 3 	
BF. 12 3 	
SPEC PW: 1 2 3
Cffl Pfft- 12 3
Company Subnlcclng Addldonal Information by 	/ /
Record Forma Used For This Inspection-
0 - 	Inspection Notebook
D - 	TSCA Inspection Confidentlality Nodce
D -	Declaration of Confidential Business Information
D -	Notice of Inspection
D - 	Receipt for Sanplea and Docinenta
D -	
D - 			
Return ail \sws«d inspect to* foraa to the CCD.
VCD USE
T»
Log A 		
lo% B
Irup. Mat._
Targ. Info.
crip. (It will be
8(c) ¦ Yes	 No
8(e) • Yes 	 No
8a LA 1 2 3 	
8(b): Yes	 No
8(d) • Yes	 No
Please use Che reverse side of this forra to Use any addle tonal cargectlng sites or
corporate nose changes. Thank you!

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IV-6
The following phases should then be completed over the telephone:
Introduction
The inspector should introduce him- or herself as a U.S. EPA
employee with the National Enforcement Investigations Center in
Denver, and that he or she has authority to conduct TSCA § 5 and
8 inspections in the EPA region in which the facility is located.
Normally the inspector need only explain that he or she is
conducting a series of inspections in the subject geographical
area and that the firm has been selected from the Agency's files. If
the inspection is routine in nature, with no suspect violations or
complaints, this fact should also be conveyed. If the inspection is
a result of a tip/complaint or referral, then the supervisor or senior
staff should be consulted as to the degree of information that
should be conveyed during the initial telephone conversation.
Insoectional Administrative Details
The date and time of the inspection should be specifically agreed
upon early in the conversation, if possible, along with the
designation of the name and title of the company's official
inspection contact, if not the person with whom the telephone
arrangements were made. The inspector will need to explain that
he or she will need to look at certain records and data, interview
necessary facility personnel, and take a tour of the operational
areas. It will be necessary to indicate in some detail what records
at the inspection site will be needed to review and possibly collect
as documentation. Safety equipment information and the facility
camera policy should be obtained, as well as directions to the
inspection site.
The company's right to claim TSCA confidentiality for any
information collected at the plant during the inspection should be
explained.

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1V-7
The facility representative should also be told that an official letter
will be forthcoming shortly from the Agency, specifying: (1) the
purpose and scope of the inspection, (2) the records to be made
available for review, (3) TSCA CBI details, and (4) an official EPA
contact.
Specific Records to be Made Available
After the introduction and other administrative details specified
above, the inspector should inquire over the telephone as to
whether the facility has submitted to the Agency (or had submitted
on its behalf) any of the following, in addition to those which the
inspector is already aware of:
Pre manufacture Notifications
Test Marketing Exemption applications
Low Volume Exemption applications, Polymer
Exemption applications, or other specific exemption
applications (Ref. 40 CFR Part 723)
Section 8(a) Level A PAIR or CAIR reports [or
whether the facility, to its knowledge, has manufac-
tured, imported or processed any Section 8(a)
Level A chemicals]
Section 8(e) substantial risk reports
Section 8(d) reports or lists [or whether the facility
has manufactured, imported or processed any des-
ignated Section 8(d) chemical]
Bona fide inquiries
Section 8(c) allegation records

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iv-e
In addition, the inspector should establish if any Section § 5(e)/5(f)
orders, consent decrees or injunctions or SNURs are in effect and
what their status is (i.e., whether currently in production or not). It
should be determined if the facility has an active Section 8(c) file
of health/environmental allegations and if the facility (or company)
has documented Section 8(c) and/or 8(e) policy/procedures on file
at the site. If not, determine where the § 8(c)/8(e) records and
files are kept, if any. Inquiry should also be made as to whether
the facility has any other TSCA related policies, procedures and/or
submittals on file and for which there might be interest in reviewing
during the actual inspection.
The status of any ongoing TSCA defined research and develop-
ment activities at the site is also established as part of the
telephone inquiry, and whether such research involves the
development of new TSCA chemicals.
If the answer is "yes" or apparently "yes" to any of the above
inquiries, or the inspector already has information that such
records or reports have been submitted, the inspector should
request that the facility representative make available the following
records, data and reports during the inspection (even if the
inspector already has some of the copies).
1. PMN(s)
a.	Copy of the full PMN submittal(s), including all
attachments
b.	Copies of all correspondence regarding the subject
PMN(s)
c.	Copies of any bona fide inquiries or TME
application(s) related to the subject PMN(s)
d.	Copy of the notice of commencement, if submitted

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IV-9
e.	All records of production and/or import, as required
by 40 CFR Part 720.78
f.	Records of production, notification and disposition for
any R&D exempt batches of the PMN substance(s)
that were produced or imported. (Records for TSCA
R&D chemicals, except for notification or adverse
health effects, are required to be kept by regulation
only for batches produced after August 5,1986.)
2. TM5f§)
a.	Copy of the TME application, a copy of the Federal
Register Notice (if not already available), and copies
of any correspondence with the Agency regarding
review and/or approval of the application
b.	All records of production, import and distribution of
the TME chemical, as required by 40 CFR Part
720.78(c)
c.	Copies of any bona fide inquiries related to the
subject TME
d.	Records of production, import, notification and dispo-
sition for any claimed research and development
(R&D) exempt batches of the TME substance that
were produced or imported. (Records for TSCA R&D
chemicals, except for notification of adverse health
effects, are required to be kept by regulation only for
batches produced after August 5,1986.)

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IV-10
3. Specific Exemptions (40 CFR Part 723^
Currently there are three specific PMN exemptions allowed
for various classes of new chemicals:
a.	Low Volume Exemption (LVE), Coded "L," (40 CFR
Part 723.50)
b.	Instant Film Chemical Exemption {40 CFR
Part 723.175)
c.	Polymer Exemption (PE), Coded "Y," (40 CFR
Part 723.250)
Records to be made available during the inspection include
the following:
LVE(S)
Copy of the LVE application
Copy of the LVE Federal Register Notice
Copies of correspondence with the Agency
regarding the exemption, including a copy of
the bona fide inquiry, if applicable
All production and other records for the LVE
material, as required by 40 CFR 723.50(o),
including records related to customer notifica-
tion, as specified in part (j).
All batch, customer, sales and disposition
records for any of the LVE chemical produced
or imported prior to the 45-day approval date.

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IV-11
Internal corporate correspondence regarding
the development and production (or importa-
tion) of the LVE chemical.
Instant Film Chemical Exemption flFCE^
Copy of the IFCE application
Copy of the IFCE Federal Register Notice (if
not already available)
Copies of correspondence with the Agency
regarding the exemption, including a copy of
the bona fide inquiry, if applicable
Internal corporate correspondence and
memos regarding the development and pro-
duction or importation of the IFCE chemical
All production, importation, training and treat-
ment records for the IFCE chemical, as
required by 40 CFR Part 723.275(1)
All batch, customer, sales, inventory and other
disposition records for all of the IFCE material
made or imported prior to the approval date
HE
Copy of the PE application
Copy of the PE Federal Register Notice

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IV-12
Copies of any correspondence with the
Agency regarding the exemption, including a
copy of the bona fide inquiry, if applicable
Copies of any internal corporate correspon-
dence 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 Part 723.250(r), including documentation
that the requirements of 40 CFR Part 723.250
(e)(1)(2) are met
All batch, sales, inventory and other disposi-
tion records for any PE material made or
imported by the company or facility prior to the
45-day approval date
4. General Inventory
a. A listing of all manufactured or imported chemicals,
as well as raw materials and isolated intermediates
should be requested. The listing should give CASR
No., trade name and chemical 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.)

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IV-13
5.	Section 8(a) Level A Preliminary Assessment Informatmn
Rule (PAIR) Reports
a.	A copy of the PAIR report, as submitted to the Agency
b.	Copies of production, batch or other records used to
calculate the reported values, including onsite and
offsite 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
c.	Copies of typical timesheets, production schedules,
costing records or other documentation used to
determine worker exposure
d.	Copies of any correspondence with the Agency or
within the company regarding reporting, interpreta-
tion, accuracy or other aspects of the PAIR submittal
Note: There are no recordkeeping requirements associ-
ated with this rule.
6.	Section 8(d) Health and Data Reporting Rule
a.	Copies of § 8(d) submitted studies and/or list of
ongoing unpublished health effects studies
b.	Copies of any internal correspondence or corre-
spondence with the Agency regarding any actual or
potential § 8(d) submittals
c.	Any existing testing data or data files relating to a
TSCA § 8(d) listed chemical, including monitoring
and/or epidemiological study data or reports

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IV-14-
7.	Section 5fe>/5ff> Consent Order. Injunction or Rule
a.	Copies of the final § 5(e)/5(f) Order, Injunction or
Rule, and associated PMN(s)
b.	Copies of any internal memoranda or external corre-
spondence (particularly with the Agency) regarding
the § 5{e) or § 5(f) order, injunction or rule
c.	Original records or copies of all records required to
be kept according to the terms of the § 5(e)/5(f) order,
injunction or rule, particularly with respect to
production, training, protective equipment testing and
product disposition.
8.	Significant New Use Rule fSNURl
a.	Copy of the specific SNUR and associated PMN (if a
new chemical)
b.	Copies of any internal memoranda or external
correspondence (particularly with the Agency)
regarding the SNUR
c.	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.
Once the inspection has been arranged by telephone, a
letter is to be sent to the responsible individual at the facility
to be inspected (or an agreed upon representative)
verifying the date, scope and other details, as necessary.
This letter should be written so as to be non-TSCA CBI. An
example is given in Figure IV-3. Additions or deletions

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IV-15
should be made as appropriate; however, the confidentiality
section (second from last paragraph) should be left intact. A
copy of the letter should be sent to the appropriate EPA
Regional Counsel and Pesticides and Toxic Substances
Branch Chief. The Branch Chief (or designee) is also to be
contacted by telephone once the inspection is arranged to
assure that there is no conflict with other Regional Office
investigations.
A "Tracking Sheet" [Figure IV-2] will also be obtained from
the DCO and filled out through Part A. This is then returned
to the DCO who will provide an accountable set of
inspection documents and any necessary equipment. The
Tracking Sheet will be returned to the inspector for
completion after the inspection has been completed. The
completed tracking sheet is then given to the designated
senior program supervisor for inspection monitoring
purposes. (Any additional sites for possible future § 5/8
inspections should also be recorded on the Tracking Sheet
once the subject inspection has been completed.)

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IV-16
Figure IV-3
NOTIFICATION LETTER
Environmental PROTECTION aGEnCY
OFFICE OF ENFORCEMENT
NATtONAl ENFORCEMENT INVESTIGATIONS CENTER
IUUOMO I] mi MW KnvII *EOC>ai Unr|l
wva cctoroo torn
Oar
'n awiflnnariori of jrxir ral^phnn* canvar^aclon on 	,
	 plans cn conrhxc jn Irwpacclan *c vatr ctnpanr'j
tacHLcv in	inter dia «it#iortCT
of Sacdon 11 of ?i« Tixic 'nUMr.aneas Con ere f ice (TXA) 11 M.5.C.
2A10. m	I9W	. Tha purpoaa of tfila
Lnapacclcr Ls Co <1*canlna cowpllanca c*1* rnqulrvntna of ctils Ace
appltcatila co cha c^antCAl sutecanc** or nLxnir** ./ltfil/1 vaur 'acLLLcv'*
prwt«M. ^/iha unulri LLka co fU rwtawand, If .i*CMMn, cnpy rarorls,
'Lin, rtaca and corraaponrtanc* tfiac ara eltfiar raq'ilrad m nal-icalnari Sv
cMa ^cr or in -ippllcAhla cn cha chwlcal aii»acancaa or mlxairm vtc* »lao, If mcontr, CO collacc official ja^>La». In
addtclm, ha/she 117 vljh co caka phocoarapha of talacMd suht*cc*.
Ha/aha -ailrf LLlca Co McahU*h tf*ac *11 TVa rieflnad ctrale*la
prorkjca.1, ptocaaaad *nri/or Luporcad ac Ci» faclllcv ara eltfitr (>) an
iha 4(h) Invwitnrr, (2> covarad *>v an approprlaca PHf or Test rtartadog
^xavclon nr. (1) sublacc co »na ochar spaclfle axaipcLon. In orrtar co
cxpadlra rhls ravtaw, plaaaa haws praparari, « cha cliaa of cfia Inapaeelon,
an Irwanccnr list of all finished <*anlg«i omrfufrs, •'acarlalj. l»-
porCBj nl Irolaccrf 1 nfrr—HlMTw*. ~ Thli Use mould Ineluda «pacific
chaalCAl naaa, tynonvn*. and erada narms. aoread b* Chan leal Ahacraccs
^«nHca Raalaerr (CAS) raahan. Plaaaa also Inelmta cfcwtlcaU In tfia
caeaaorla* tfiae hava haan Jroppad ovar t#ia paac flva vaan. "tr./Hn.
			 wtll also vane Co rwvlaw rananrc^ anrl rlavaLapnanc i*i»lc>ls
inrl procarturat aa ralacad en TSCA raqiilrvwiRS.
Aa part of dia inapaccton, ha/aha aUo plana 00 ravlaw an» T^Ca
faction R(c) lUasidona on flla m addldon 03 nvlaAnt year plane'¦
pnllelaa and procaduna witfi rwpaec co TST> lacdm 4(e) and fl(a) raqiilra-
<«nca rtUtad co laconfcaaplna and rapordna of advarxa affaccs of nam-
facoirad and prooaaaarl d<• HlacLoaad bv PPA ml* In
aceordanra wlrt 1ft* preeadnrwt sac brtfi In rSa ravdactm (clcad ahnwa).
Am aud> cLala for confldancUllor vit oonfoiK on dw requlrwwnca we
forth In «J c.F.R. <^rrtcn Z.^HKb).
tf nu hava jrrr q>«sctona, plaaaa amcacc
ac	• Thai* hi fn» »r»ir «aal
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V-1
V. INSPECTION MANAGEMENT
A.	INTRODUCTION
Actual onsite inspection activities beyond administrative functions (see
Section B) will depend on the overall scope of the inspection,
professional judgment and the extent of requested records and data
(Chapter IV). The primary purpose of the inspection will be to identify
areas of industry noncompliance and to effectively document such
findings so as to meet both penalty policy requirements and rules of
evidence. Possible TSCA Sections 5 and 8 violations are listed in
Appendices A and B, respectively (Enforcement Response Policies).
Specific, but less significant phases of the inspection, will be to acquire
general facility information and to provide TSCA awareness, as
appropriate.
This and the succeeding two chapters are designed to carry the inspector
through an inquiry process whereby he or she can address the basic
elements of a TSCA Sections 5 and 8 inspection with some assurance
that the minimum areas of concern will be covered, and that the most
significant potential violations will be identified and properly
documented. These chapters are not intended to serve as checklists, as
inquiries should not be limited solely to the questions and topics given
herein; the inspector should ask additional questions, pursue other
avenues of inquiry and take whatever followup action is necessary to
uncover and document noncompliance.
B.	ADMINISTRATION
Entrv: Section 11 of TSCA provides the authority for an EPA inspector to
enter an establishment where chemicals are manufactured, processed or
stored, and places certain administrative requirements on the inspector.
It also requires that the inspection "be commenced and completed with
reasonable promptness, and be conducted at reasonable times, within
reasonable limits and in a reasonable manner." A more complete
-------
V-2
discussion of these requirements is presented in the U.S. EPA TsrA
Inspection Manual*. Volume One, Chapter 3.
The inspector should arrive at the inspection site promptly at the agreed
time. The inspector should not sign any liability waivers, either when
initially signing a visitor's log at the reception desk, or when entering
other plant areas. When the proper facility officials have been located,
the inspector should introduce him- or herself as an EPA inspector and
present his or her proper EPA identifying credentials, as required in
Section 11. The credentials must be presented whether or not identifica-
tion is requested. Credentials should never leave the sight of the
inspector and may not be photocopied.
Consent to inspect the premises must be obtained at the time of the
inspection. The fact that the inspector is allowed to enter the facility
constitutes consent; express consent is not necessary. If entry is denied,
the inspector should attempt to determine the reasons for denial and try
to work with the company officials to overcome perceived difficulties.
Care should be taken to avoid threats of any kind, and diplomacy should
be used to avoid any sort of confrontation. The facility management can
be advised that the issuing of a subpoena is one of the Agency's options
for obtaining necessary records and information, and that it is a potential
prohibited act in itself under Section 15, under the TSCA statute to "fail or
refuse to permit entry or inspection, as required by Section 11." If entry is
still denied, the inspector should withdraw from the facility and contact his
or her supervisor. The supervisor and NEIC attorneys will determine
further action.
In the event that entry is denied, the inspector should note all observa-
tions pertaining to the denial in the field notebook.
Opening Conference: Once entry and inspector identification are
established, an opening conference is initiated and a completed TSCA
Notice of Inspection [Figure V-1] must be presented to the responsible
facility or corporate official. It must be dated and the time of inspection
entered. Normally, both boxes are checked along with "Sales Data" and
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V-3
Figure V-1
TSCA NOTICE OF INSPECTION FORM (Example)
Ul CNVIftONfcllNTAL PROTECTION 4Q|NCV
A WA1MN0T0* 00 J 0*4 0
P" T0XIC UBSTANCIt CONTROL ACT
NOTICE OF INSPECTION CP^'3'2.
firm Aeprmi 1
0M«« 2070-000?
fwntJji-M
1 INVESTIGATION lO£NTlP(CATlON
2 TIME
3 FIRM NAME

DATE | INSPECTOR NO
daily seq MO



4 INSPECTOR ADDRESS
0 FIRM ADORESS
REASON FOR INSPECTION
Undar tht authority of Section 11 of tht Tone Sutauncn Control Art
G For tht purpou of iniptciing (including taking umpltt. photographs itatamanti. and othtr iraotction tctivititi) in ttublufv
mtnt, fteility, or othtr prtmittt m which chamicai ubitinctf or mixtuw or kiicJh containing umi art manufactured, proe
mtd 0» Ktortd or htld btlort or alltr thair diitnbution «n commtrct (including record). Wt>. ptperi, procvuti, control*, and
facilititt) and tny convtyanct uatd to transport chtmieil subiuncti. miitturts, or artitfti containing umt in connection
with ihtir distribution in commtrct (including rtcordi, filti, paptrt. prootaai, control*, end facilititt) (Miring on whtthar tht
r»quir«fnmti of the Act •ppl dau tpeeified m A through E above n « follow*.


NAM(

TITLE
0AT1 IIQnio
TITLI
BATI HOMO
CM Perm 77404 <12431	OUPCCDON «U
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V-4
"Research Data" under the second listing. The nature and extent of the
inspection will normally be given as "To verify compliance with Sections
5 and 8 of TSCA." Other sections can be added, if necessary. If it is
known that "Financial Data," "Pricing Date" or "Personal Data" are
necessary for review, these boxes should also be initially checked (or
checked later and initialed by both the inspector and the company
management official). Additional rationale should also be provided, if
requested. Directions for completing this form are given in the U.S. EPA
TSCA Inspection Manual7. Volume One, Chapter 6.
An explanation of Agency management of TSCA Confidential Business
Information (CBI) should be provided and officials presented with a
TSCA Inspection Confidentiality Notice [Figure V-2]. Any questions
concerning CBI should be discussed. The inspector should then outline
inspection plans with facility personnel. During this phase of the
inspection, the company official(s) should also be informed of the
purpose and scope of the inspection, and an inspection schedule agreed
upon. The initial records to be inspected should be identified, and
arrangements made to interview necessary facility personnel. Other
general questions pertaining to TSCA should also be discussed with
facility officials at this point, if appropriate.
During the opening conference, the inspector should request company
organizational charts. Facility floor plans, maps and/or diagrams should
also be collected, if he or she feels that these might be useful. He or she
should also determine facility safety regulations and be prepared to meet
any necessary requirements. If applicable, facility policy on the taking of
photographs should be discussed. An instant film type camera (e.g.,
Polaroid) should be used, if necessary, so as to allow review and
identification of any photographs during the closing conference and to
meet TSCA CBI requirements.
Closing Conference: When the inspection is complete, the inspector will
normally hold a meeting with facility officials to summarize the
proceedings (avoiding the drawing of any conclusions as to potential
violations), discuss any inspectional observations and answer any further
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V-5
Figure V-2
TSCA INSPECTION CONFIDENTIALITY NOTICE (Example)
oEPA
ui a
WCV
WASHINGTON. DC 3O4S0
TOKtC SUOTAMCE* COtfTROL ACT	g- 3/b
TSCA INSPECTION CONFIDENTIALITY NOTICE
F«m A0trom4
OJf J No. iQ TQ4QQT
Ajprvmt *aptrm I 4MI
1 INVESTIGATION IPENTjFICATtQN
DATE
1INSPECTOR NO
OAIIYSEO.NO
2 FIRM NAME
4 MUaQMEU
3 INSPECTOR NAME
8 INSPECTOR AOORESS
6. CHIE* EXECUTIVE OFFICER NAME
TO *
It l§ poadtla thai EPA will naW public reouaati for rvt«a« el tha
information ofctafrad during intact ton o< tha faculty	fucft
•HII be handled by CPA Iff ecBome»Ha wfth proriaona of (ha
of Information Act (FOIA), 6 (JSC 66} CPA ragwiationa
hMd thereunder. 40 CF R P«rt 2 and Toa* lutwnai Control
Act TOO) Section 14 EPA b required to mail Inapectlon data
milable m naponae to FOIA raowaro tmle» the AdmMatrvtcr of the
Agancy datermlnee (hat the 4r> contain information emitted to confi-
dential treatment or nrwy be arttfthaid tram reteaaa under other auep-
ikm of FOIA
Any of 41 in ¦rtomvtton collected by EPA di^ng me Inepanion may
be claimed Mnfidemal If ft relate* to trade auTU or commervai or
flnancM mrrwrj xtmt row conaider to bo confidents buainaai 1nfor>
mat ton tf you mmn t CSl dalm, EPA will tftadoee the nformation
only to tf* extern, and bv maana of tf* procedures mx fortf> in tha
regulations (dtad Aovat governing CPA'a traavn«ni of confidential
bvdnaae Information Among other things tf* regit tetioni raqulra that
EPA notfty yow in rtvxwa of pub4kfy diartoang any Information
you have claimed ¦ confdentlel buaJnMB informatton
A snfldenttal b^nea Information (COIk data may ba a
time You may assen a CSl dalm prior to. dt*ing. or afar the Irifor
motion b collected T*m dadarwlon form waa dnaiopad by 9m Agancy
to aaetft yog In 4aaertlng • CSl datm It It la mora convenient for you to
aaan a CSl daim on your oean awtanery or by mrtdng tha IndMdwd
document* or aanples "TSCA oonfidentiel budnaas Information." R to
not necoMry for you • woe this form. Tha inaparaor wflt bt #ad m
maiar any questions you may hua rggvdbt tha Apncy'a CSl
RT A OOMPtOCNTlAL SUSJNtSS INFORMATION CLAM
2
WNla yow may Mm any colli
»Information, «i0)
I Ya
dantMtcy of tha Mo
to «ha autfi maaurvi
Informal km or amen • conflam-
arv wujary » ba ^fmte H ihay
maau tha foikwiri vftark
i maaauraa to preeact tha ceeifk
Ulan and n Imandi to aontinua
Tha Information b not. and hai not boan. raaaon^h obtalnabfa
without your oompany't oonaam by otnar parvont (othar chart
flewnffwitu bodiai) by iaa of laghimata maam lothar than
dlaco«ary baaad on tfewnng of wadai naad In a ludktal oi
«uaaiHud«al proceeding!
T>w IMormatton b not public** etaJlabte adowhara
4 O^adoaura of the information woutd oai
harm to your company1 a compathhv portion
At tha flompmleri of tha m^wctlgn, yow w4fl ba ghwn a racelpt for all
documenn, aampl— and other maiarlaia collected At that time yow
may make tfuma that «ama or all of tha WtormatJon la confidant lal
bwalr— information
If yow m not authorised bv yowr comaany ao aaaart a CSl ctiifn^ Vib
notice «rill ba »«i by canHied mall, along wtrti tha receipt lor docu-
ments, wmpiae and other matai^li m tha CMef EocutK* Officer ol
your firm wflhln I (toyt of tha date The Ch*i EeeeutkaOWcer muel
return a auwnant «adfylng any Mcrmatlon wtikti tfiould racaKa
eonf^ntjal trartmam
Tha naamant from Chief SacutKa Officer rf«oi*d ba addrwaad
and mailed by ngbtnad, laturmauaHW reguevtad mell aamn 7 calen-
dar Ayi of naci of this Nodce Oabna may ba nadi any the
after the Irapactlon, bwt In^octlon date wfH not ba entered bits the
fecial twrtty eyatam for TSCA confldamlal bwaJnaaa Information
«n0 an official confidentiality claim b made Tha dna «KH be handed
inim tha aa* i'i routine aacurfrr aiwwn unle* and until • deim b
TO BE COMFLCTED BY FACILITY OFFICIAL REC8IVIN0 THIS NOTICE
r have racelyad w* read tha not ha
it thate a no ona on tne pram baa crt ma faciiny wr^^uvZonSn^rwEa
b»ainaa aonfttnxiailTy daima for the ftrm. a copy of MaNotlea and"othar
Intact ion matartab etfl be aam to me ccrrgai'ii-^ guef caacwtha officer If
thara b another amity offUal mho MuM etao raoaNa thb Information,
ptaaee deelgnate be tow
•ION
NAM!
TITH
dati name
TBBTH
CPA Fan* 7740-4 |1S4V
(Nl^fCTOCI mi
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V-6
questions. A written TSCA Receipt for Samples and Documents [Figure
V-3] must be issued to facility officials, describing each item taken, and
which must be signed and dated by a corporate official and the inspector.
An authorized facility official may make a confidentiality claim for
documents or other items provided to the inspector, and should do this by
listing those items on a TSCA Declaration of Confidential Business
Information [Figure V-4]. The inspector should not suggest or advise that
certain items be claimed confidential; this decision is to be left entirely to
the facility official. However, questions concerning whether a
confidentiality claim is appropriate should be discussed with the official.
All declared items should meet all four criteria spelled out on the form,
and those that don't should be strongly discouraged from a CBI claim.
Procedures to be followed in the event that no onsite official is authorized
to make confidentiality claims are discussed in the TSCA Inspection
Manual/ Volume One, Chapter Three, Part 5. Completion of receipt and
confidentiality forms is given in Chapter 6 of the TSCA Manual.
If additional documents or information are to be transmitted to the
inspector by the company, a date by which the information is to be
provided and the mechanism for transferring the information to the
inspector should be agreed upon. The inspector should make every
effort to obtain all necessary records during the inspection, thus keeping
the need for followup information to a minimum.
C. ORGANIZATION AND NATURE OF FACILITY
The following general information should be obtained as background
information during the opening conference or early phases of any TSCA
§ 5/0 inspection:
-------
V-7
Figure V-3
TSCA RECEIPT FOR SAMPLES AND DOCUMENTS (Example)
V* IMVlflOMMtNTfcL PflOTflCTtON &OIHCV
jk **IH INOTON K3MM
TOXIC SUWTAMCIIOOMTHOL ACT - 3^-0
V LI /% RECEIPT FOR SAMPLES AND DOCUMENTS
Form Ajjprova^
0M8 rio 20TWXO7
Aeprovtl iQftt yjl 46
1 INVESTIGATION IDENTIFICATION
2 FIRM NAM!
Date IkPECTOft NO
DaIlVUQ no
I IN5JSCT0H ADOBES®

Th» document! and umpln of ch«m»c*l tubrar^n «nd/iv mixturn dticrited b«low w«r« collacttd in connection wiih (ha
•eminiftrtiion ind «Afor«nwit of ih* Toaie SubRirxa} Control Ad
niCCIPTOr TMI DOCUMENTED ANO/OR &I.EIS) DESCRIBED IS HEREBY ACKNOWKOOCD
HQ
OtiCAlPTlO*


OTTWHAL.
INSMCTC* tlOMATum
MCtFllMT tlQNATUM
NAU|
NAM!
TITLE
bATI SIONVS
TITVI
DATE H9n(D
EPA Form 7740-1 (12-82)
INSPECTOR'S HU
-------
V-8
Figure V-4
TSCA DECLARATION OF CONFIDENTIAL BUSINESS INFORMATION
(Example)
«*»hinoton oe iomo
TOXIC MCTANCtl CONTROL ACT
DECLARATION OF CONFIDENTIAL BUSINESS INFORMATION
'•rm —
XfO-OOO?
Itjmu 4 l'-4S
1 INVESTIGATION IDENTIFICATION
2 FIRM NAME
DATE i INSPECTOR NO
oajiysiq.*o
3 INSPECTOR ADDRESS
4 FIRM A0DRES8
INFORMATION OCSIONATIO AS CONP lOINTtAl IU9INIU INFORMATION
NO
OliCRl»TlON


ACKNOWLEDGEMENT BY CLAIMANT
Tha gndarufnad icknowtedni that tfia *rfor notion doeribad abow • tognatad ¦ Confidant*! 8w Information ondw Section 14(e) frf tin
Toxk SybeiflMi Control Act The wtdarpgntd hirttm mknowbdgm tfwt a avthoruad to maka da«ni tot hnfim Rim.
T>w awdar»fftad uftdvntntfi that tfuflangaa to conftdamrtJt^ dwni may ba mada, and (tin clams an Ml Ukity tt bt wphalfl unta* tha tirfor
mstten nam tha Idlewmg jiidataac (1) Tha company haa takan mwin to pfottct (ha canfidantWlty of (hi Infonwtion and ft mtwdi ta
continua to ttfca weft maaaum. (2) The nfomatton ii not. and hoi not toaan naionaNt attainatta anthem tha company'! conant fry othai
ptrmm (othar than fovarnmintaf bodml by m of lafitanata m«m (ottw than dianvary bavd on a Aotrfnf of vadaJ naad in a pdklaJ av
ijy jmlriat procaarf r*|). (3) Tha wformation a net puWkly avtttabU abawharc. and (4) Osloaira of tha Momatfon veutd cauaa ubatafltid
harm to tha company'! compvtmva paction
INSMCTOR 9I0NATURI

NAMI
NAM!
mil
SATI iiqnid
TITLI
DATI 1IQNID
l» rm 7740-1112-C)	INtFCCnON «U
-------
V-9
The organizational structure of the facility, including the names
and titles of: (1) management officials, (2) department heads,
(3) environmental, safety and regulatory officials, (4) key research
and development personnel, and (5) other officials cited in
available Agency submitted documents. Any recent or proposed
organizational changes. (Obtain a copy of the organizational
structure for a report exhibit, if available.)
The ownership history of the facility in terms of its origin and
various corporate relationships (including pertinent dates)
The organizational and operating relationship of the plant or facil-
ity to the overall corporate structure or parent firm (if appropriate).
Is it an independent subsidiary or a wholly owned and managed
operating division? Where is the corporate, division and/or group
headquarters? Is the firm international in scope or primarily con-
fined to U.S. operations? Whom does the plant manager or other
senior official report to, and what are his or her title and office
location? What are the approximate gross and net sales of the
overall corporation and what percent or share is contributed by the
inspected facility? [A corporate (or plant) promotional or financial
brochure will be useful toward acquisition of some or all of this in-
formation, as well as the Dun and Bradstreet report.]
The principal activities of the inspected facility from an operations
standpoint, i.e., manufacturing, importing, processing, R&D, sales,
packaging, technical development, assembly and so forth.
The principal chemicals or chemically related products. What
general types of chemicals are produced and what is their market
intent, (e.g., electronic components, polyester resins, raw
materials, dyestuffs, coatings and so forth)? Are chemicals also
manufactured, imported or processed for TSCA R&D purposes?
The size of the facility in terms of acres, city blocks or other
approximate area measurement. How many buildings (approxi-
-------
V-10
mately) are there? How many large reactors and/or mixing vats?
What and how many commercial size filtration, centrifuge and
distillation units are onsite? Are pilot-plant facilities available and
being used? Is there a rail or barge depot? Are there major
storage tanks or a tank farm available for raw materials, finished
goods and/or intermediates? How are finished chemicals or
chemical products shipped from the facility (i.e., in bulk, small
containers or pipeline)?
The number of employees at the facility and their general make-up
in terms of production, sales, management, research/ develop-
ment, quality control and so forth. Have there been any recent
major changes in staff size or distribution?
The corporate fiscal year for 8(a) Level A and inventory update
purposes, if necessary
The types of records retained by the facility to record total
manufacture, batch production, imports, sales, inventory, waste
and other key statistics, by chemical.
The following two questions should also be answered during the
preliminary phase of the inspection.
(1) Does the inspected facility or parent company have any
general or specific policies related to TSCA activities or
compliance, particularly with respect to Sections 4, 5, 6, 8,
12 and/or 13? If so, these policies should be reviewed as
part of the inspection and collected, if necessary. Any
deviations from these company policies and procedures
noted during the inspection should be documented in the
report and brought to the company's attention, whether
TSCA compliance is involved or not.
-------
V-11
Are there R&D activities taking place at the inspected site or
at a nearby associated facility? Are new chemicals, as
defined by TSCA being (or likely to have been) manufac-
tured, synthesized, imported or processed, or are existing
chemicals only being physically modified to meet customer
specifications? If new TSCA chemicals are being synthe-
sized or manufactured onsite for commercial developmental
purposes, then proceed to Chapter VLB for further points of
inquiry regarding R&D. If R&D for the site occurs elsewhere
or also takes place at other company or contract facilities,
ascertain where these activities occur and the organiza-
tional relationship of these other sites to that being
inspected.
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VI-1
VI. TSCA SECTION 5 INSPECTIONS
INTRODUCTION
The TSCA § 5 phase of an overall TSCA § 5/8 inspection will normally
include compliance review for any or all of the following activities that
may be associated with or takjng place (or have taken place) at a facility:
Research and development (R&D) exemption
General 8(b) chemical inventory status of all produced and
imported chemicals, raw materials and isolated intermediates
Specific premanufacture notification (PMN) related chemicals
Test Marketing Exemption (TME) applications
Low volume (LVE), polymer (PE) and instant film chemical
exemptions (IFCE)
TSCA Section 5(e)/5{f) orders, rules or injunctions
New chemical Significant New Use Rules (SNURs).
Specific information for ascertaining compliance with each of these
topics at a facility are given in the following sections. Headquarter
inspection guidelines for § 5 inspections are given in Appendix E. The
§ 5 Agency Penalty Policy is given in Appendix A.
RESEARCH AND DEVELOPMENT fR&Dl EXEMPTIONS
(40 CFR PART 720.361
The following questions should be answered to the inspector's
satisfaction by company officials or through records review for any facility
employing (knowingly or unknowingly) the TSCA R&D exemption:
-------
VI-2
Is there a discreet research and development laboratory or
operation at or near the facility being inspected? Are new
chemicals (according to TSCA) being synthesized for eventual
commercialization? If so, what different kinds of chemicals are
being synthesized (from the standpoints of general chemical
structure and intended use)?
Does the facility (or corporation) have written policy that addresses
the development of new chemicals? Does this policy address all
of the requirements of TSCA, specifically the stayed PMN
provisions that took effect August 4, 1986; [these relate primarily
the recordkeeping requirements of 40 CFR Part 720.78(b) and
excess use and notification requirements of 40 CFR Part 720.36]?
Collect a copy of the R&D policy if: (1) additional time is needed
for its review, (2) there are deviations from the requirements of
TSCA or (3) there are operational deviations from its provisions.
Does the policy address amounts of the R&D material that can be
produced, designation of technically qualified individuals and
procedures for risk evaluation? Are "prudent laboratory practices"
documented? Does the policy specify sample labeling and other
customer notification procedures for R&D identification and health
risk purposes?
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 the general policy questions
previously mentioned, the inspector should determine facility operations
and recordkeeping practices so as to be able to establish the typical or
normal pathway of a new chemical from initial benchtop synthesis
through pilot-plant scale-up to final commercial production. Of major
concern is the determination of the responsible person for specific R&D
-------
VI-3
activities ("technically qualified individual"), and the policies lor
recordkeeping, notifications and health risk assessments.
Through interviews with appropriate senior laboratory personnel at the
site, the inspector should determine who the senior product development
or research chemists are for the various product lines of commercial
interest. In this respect it may assist the inspector to prepare a chart of all
use and/or chemically discreet classes of compounds and then
individually ascertain if: (1) research on new chemicals is ongoing or
not; (2) if so, where is this research taking place; and (3) if taking place
locally (i.e., at or near the inspected facility or under immediate contract),
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 limited verification, as
appropriate. Laboratory notebooks and interviews with research
chemists represent the point of initial inquiry. At a minimum, several
chemicals should be selected from various use and/or chemical cate-
gories for further inquiry. The synthesis of potentially new commercial
compounds in the laboratory should be noted, including dates, starting
materials and proposed target compound. Additional purification steps
and any subsequent identity or property determinations should also be
noted. The selected new compounds should be tracked through inter-
views and records on through risk evaluation to their current status.
All bona fide chemicals noted to not have been found on the TSCA 8(b).
Inventory should be confirmed for R&D exemption compliance. Thus, the
inspector should obtain copies of all such bona fide inquiries prior to
each prospective facility to be inspected.
Determining if newly synthesized or imported chemicals at a facility truly
meet the R&D exemption may be difficult to immediately establish, i.e.,
whether a compound is listed on the § 8(b) Chemical Inventory (open or
closed) or not. Company chemists and/or other officials should be
questioned as to whether a bona fide inquiry or other inventory search
has been conducted for a compound in question. If in doubt, assume the
-------
VI-4
new chemical under R&D review is fl£i on the § 8(b) inventory, and
document potential violations accordingly, even if later the chemical may
be found to be listed.
Any new TSCA R&D exempted chemical synthesized or imported by a
facility after August 5, 1986 is required to meet the recordkeeping and
notification requirement spelled out in Tables Vl-1 and 2. The
requirements in these tables are summarized from the stayed PMN
provisions , which were promulgated April 22, 1986 [Federal Register 51.
#77 (15099-15103)]. If these requirements are not being met, or if
records or notifications appear to be incorrect or missing, then these
potential violations should be fully documented through copies of
substantiating documents and/or statements from company officials.
-------
Table VI-1
RECORDKEEPING REQUIREMENTS
VI-5
Who Must Keep Records	Requirement	Authority (40 CFR)
All manufacturers using
the R&D exemption
(except labs using prudent
lab practices)
1.	Copies of or citations
to information
reviewed to determine
risks
2.	Documentation of the
nature and method of
risk notification
720.78(b)(1)(i) &
Labs using prudent lab
practices
1. Documentation of
prudent lab practices
720.78(b)(iii)
Manufacturers distributing
R&D substances to
persons outside their
employ.
1.	Names and addresses
of those who received
substance
2.	Identity of substance
3.	Amount distributed
4.	Copies of written
notification
720.78(b)(iv)
Producers of more than
100 kg/year
1.	Record of identity of
substance
2.	Production volume
3.	Disposition
720.78(b)(2)
-------
Table VI-2
REQUIREMENTS FOR NOTIFICATION OF RISKS
Who must be	Method of	Content of
Notified	Notification	Notification	Authority
Persons	Any appropriate
employed by means
a firm for
R&D work
1. Risks associated 720.36(a)(2)
with R&D
substance
Persons not
in a firm's
employ to
whom it
distributes
R&D
substances
In writing
1.	Risks associated
with R&D
substance
2.	Requirement that
substance be
used only for R&D
720.36(c)(2)
C. SPECIFIC PREMANUFACTURE NOTIFICATION fPMN) COMPLIANCE
1. Inspection Sites
Generally PMN (40 CFR Part 720) enforcement related information
can be divided into three or four discreet categories based on cor-
porate functions (or locations) from which supporting production
information and/or data may have derived. Therefore, a total spe-
cific PMN inspection may be rather inconvenient to complete, as
some PMN inspections will require visits to multiple sites. The
PMN form is given as Appendix C for reference purposes, The
four potential sites of PMN information are summarized as follows:
a. 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
-------
VI-7
headquarters of the company, and will normally be the
location of the personnel identified in items 1a, 1b and often
2 of Part I of the PMN form (Appendix C). R&D related
activities often takes place at this location. As much infor-
mation regarding the PMN should be confirmed at the
submitting office as possible, particularly if chemical testing
and/or production data can be brought together at this loca-
tion for compliance review purposes. A followup inspection
will usually be conducted at R&D and/or production facilities
if there remain any questions about the PMN-related data or
records.
Research and Development Facility
The Research and Development facility usually represents
the site where the initial synthesis of a new TSCA chemical
took place, as well as where it was identified and where its
basic chemical and physical properties were determined.
This site may be the same as that of the submitting office;
however, the Technical Contact (Item 2 of Part I of the PMN
form) will often be an R&D associated individual. In gen-
eral, the technical information of Parts I and III will require
verification at the R&D site, particularly the substantiation of
the chemical structure of the PMN chemical. This will
usually require verification by a chemist, thus, spectral and
other data should be collected by non-chemist inspectors
for further review. (These analytical data should also be
compared with ongoing production quality control data, if
possible.) Byproducts and impurities, as well as their
method(s) of detection, will also require substantiation at
the R&D site, as well as the validation of associated analyti-
cal methods and associated detection limits. This will also
usually require review by a chemist. The completeness of
test data submittal (PMN Part III of the PMN form) should
also be verified at the R&D site to the extent possible.
Production and/or Import Sitefc^
-------
VI-8
This is the facility (or facilities) where a PMN chemical is
being commercially produced (or imported) and, thus, will
normally be the site identified in Item 1 of Part II on the PMN
form. This will usually be the site where the PMN
production or import records are kept, and thus represent
the most important site to visit for PMN review, since any
production or input of the chemical prior to the 90-day
review period or more than 30 days before the notice of
commencement (NOC) is submitted, will be verified here.
d. Processing Site
This site is where a PMN chemical 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 U.S. The
site may or may not be controlled by the chemical
manufacturer, as described in Part II of the PMN form.
(Except for importers, this is the lowest priority facility to
inspect of the four described sites.)
2. Scopg
A complete specific PMN inspection will address all of the
following aspects, and may require visits or information gathering
from any or all of the aforementioned sites.
a.	Initial commercial production dates (including NOC
verification)
b.	PMN accuracy (technical content)
c.	PMN production records
-------
VI-9
3. Guidelines for Inspection
Guidelines for assessing industry compliance with each of these
three categories are provided as follows:
a. Initial Commercial Production Dates
This is the most important slement of the specific PMN
inspection. Two critical dates are important from a compli-
ance standpoint:
The 90-day review date
NOC date
The inspector should know these two key dates for each
PMN under compliance review, as appropriate, prior to a
specific PMN compliance inspection. The 90-day review
date for a PMN can be found in the Status Summary
printout (example page given in Figure VI-1) which is
issued periodically by the Information Management Division
(IMD) of OTS, or in the appropriate Federal Register Status
Reports, the latter of which are issued on an irregular
monthly basis (example is given in Figure VI-2). The notice
of commencement date, if filed, for a specific PMN chemical
can usually be found on the "Notice of Commencement
Listing" (example page given in Figure VI-3, which is also
updated periodically). This listing has been found to be
inaccurate for unlisted NOCs, thus, verification should be
made with IMD accordingly.
-------

N0N-CB1
HNI)*R»I
CHG PflH •
PROGRAM
MANAGER
PMN STATUS UPDATE REPORT
PAGE;
DATE END NOTICE
HEC'O PERIOD
SUBMITTER
93 J »•
»»NON-CBI
* »
DATE: 10/00/87
CHEMICAL NAME
IN1ERIM
STATUS
DISPOSITION CHG
• P-67-1601 JOKES D
08/19/6? 11/16/67 1NTEREZ INC.
MODIFIED POLYMERIC AMINE G
FOCUS DROP
NOTICE OF COMMENCEMENT DATE: 00/00/00
P-67-1602 ALLISON RA	06/19/67 11/16/67 »i» CBI »«
NOTICE OF COMMENCEMENT GATE: 00/00/00
it P-67-1605 JONES 0
08/19/67 11/16/67 »¦ CBI »»
NOTICE OF COMMENCEMENT OAT£: 00/00/00
* P-87-160* JONES D
0B/19/B7 11/16/67 *» CBI «»
NOTICE OF COrtlENCCMENT DATE: 00/00/00
POLYURETHANE POLYMER
ALKYL I'HOSPHONJC ACID
ALKYL PH05PHQHIC ANHYDRID G
E
PRE-FOCUS OfiO
P
FOCUS DROP «
FOCUS DROP ¦
CO
3
H
c=	~n
cn	to"
cz	^
~D CD
rn
DO
rn
"D
O
J3
H
• P-67-1605 JONES 0
06/19/67 11/16/67 ¦» CBI •«
ALKYL PHOSPHONIC AhWYDRIO G
E, HOMOPOLYMER
FOCUS DROP
NOTICE OF COTVIENCEMENT DATE: 00/00/00
¦ P-67-1606 JONES 0
06/19/67 11/16/67 «¦ CBI
NOTICE OF COnrtENCEMENT DATE: 00/00/00
6BGYL PHOSPHONIC ACID. HO G
HOPOLYMER
FOCUS DROP
<
«
O
« P-67-1607 JONES D
06/19/67 11/16/67 «» CBI «¦
ALK1L PHOSPHONIC ACID. HO G
HOPOLYMER, ALKALINE METAL
SALT
FOCUS DROP
NOTICE Of COMMENCEMENT DATE: 00/00/00
-------
Figure VI-2
PMN FEDERAL REGISTER STATUS REPORT
VI-11
30612	Rifiit«r / Vol 11 No itt / Wednesday. Aujuil V 1080 / NoUcw
CNVlflONIIEIffM. HOT1CT10W
AQEMCY
I OTTVM0K FKL-IOU-t I
Prwuwnutectur* Ho Boot* MonMy
tun* n«t«rt lor lUrcn ilfl
MUNCV Environinenial Protection
Ajeney (EPA1
4CTWC ,N0HC»	
•uaMMAur S«ciioq 5(dM3) of the Toxic
Subttancet ControJ Act (TSCA) rrqwrti
EPA to laaue • L»i in the Ftdmi
Rtftatar eecfi month reporting the
premanuTaciun ooticea (PMNil pending
befort th« Agency and the PMN* lor
which the review ptnod ha #*pjred
tinea publication of lh« laat monthly
eummary This it the rtpori Tor March
1966
Nonconfidential portion* of the PMN'i
may be aeen w fUn N"E-C004 •( the
»ddm» below b#tv«naooin and
4 00 pm Monday ihroujh Fnday.
excluding legal holiday*
tooftllt: Wnticn eorwnenia. identified
with the document control number
lOPTVUOMI end thupeciFcPMN
number aheuld be tent eg Document
Control Officer (TS-790) Confidential
Dau Branch Information Management
Division Office o/Tonic Subatanc**,
Environmental Protection Agency Ra.
E-an 4m M Str*u SW„ Waehjnftoa.
DC 10460 1202) 3&2-JU2.
H# warn** BtfOftMATiON coanAcr.
Wendy Cleland Hamnett
Pretnenufacturt Notice Management
Branch Chemical Control DiviatanfTS-
794) Office of Toxic Subataneae.
Environmental Protection Afency Jto.
E-6U 401 M Street SW„ Waehtnfton
DC20M0 1202) 1«-3725
MPOtfMirTAjrr «ro«na*noac The
aonthly aiatui report publiahed In ihe
Fodtral Reflalar ae raquind under
Mction WdKJl of TSCA t90 Stat 2012(15
USC 2504)1 will identify (a]PMN»
received dunr\| March [bfftifNa
rtcalved prtviowify and itlll under
rtvrew *t tht eod o/Mascfi fcj PM#N» /or
which the notice review period bat
ended during Marcb (d) chemical
lubatancae for which EPA hae rtcaivtd
• notice of commencement to
manufacture during March, and (aj
pMNe for which ihe rtview period haa
b«ert impended Therefore the March
IBM PMN Starua Report ta betng
published.
Dated |uJy 24 W
D—ha Pro.
Aetinj D'ftcior Information StonGt*tr\*n
Oiffton
Pre/bjou/eclw* Notfcte MooihJ> Suiu* Rapoet March Ifl*
2M P«(M	I
-------
VI-12
Figure VI-3
NOTICE OF COMMENCEMENT LISTING
NOTICE OF tOUflENCEtlENT LISTING
CASE	HOC DATE
NUMBED

p-ao-ozss
OS/19/81
P-80-0257
0 3/0 3/S1
P-eO-0258
0 3/09/81
P-80-0260
12/18/80
P-80-0262
06/24/81
P-80-0263
01/07/81
P-80-0268
Of/01/81
P-80-0269
OS/01/81
P-60-0270
0 7/08/81
P-80-0273
01/08/81
P-80-0274
01/08/81
P-80-0275
01/07/81
P-80-028J
04/20/81
P-80-0286
02/19/81
p-flO-0269
03/01/81
P-80-0290
03/01/81
p-«a-02fi
04/29/ai
p-40-02^2
05/15/91
P-ftO-02^
05/19/81
p-«a-02
-------
VI-13
The NOC should not have been filed if commercial
manufacture or importation of a PMN chemical has not
been initiated. A PMN under review may have been
formally withdrawn, in which case there will not have been
a 90-day review date, however, no commercial manufacture
or import should have occurred, and any such commercial
manufacture or import will be deemed to be in
noncompliance.
b.	PMN 90-dav Review Date
The inspection requires ascertaining production/import
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/import after the
NOC, if applicable. This will be accomplished through:
(1) interviews with company officials and (2) review of
research, production, batch and business records. Sales
records may also need to be reviewed and copied to
substantiate commercialization of a chemical. Batches
claimed by company personnel to be R&D should be
verified as such.
c.	Statements
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 a signed statement or letter should be obtained
from a knowledgeable corporate official stating the exact
purpose, details of production and disposition of any
batch(es) in question.
-------
VI-14
d. Records Review
The first source of records to review for a PMN inspection
should be the R&D, TME and PMN records (as applicable)
that are required to be kept according to 40 CFR Part
720.78. These records, which may be available in a variety
of "in context" or other summarized forms, should be verified
with routine production, batch, inventory and sales records
for at least 1 year prior to the official 90-day review date.
Company batch records may be kept by product, reactor
vessel and/or chronological sequence and should be also
randomly checked, as applicable, for evidence of any early
commercial production of the PMN chemical. Import PMN
chemicals may also be verified for compliance via review of
purchasing, import, duty or inventory records.
if the PMN chemical is being further reacted onsite to man-
ufacture other chemicals (i.e., being used as an isolated
intermediate), or is being processed into mixtures or incor-
porated into articles, then records reflecting production,
sales and inventory for these secondary materials should
also be reviewed for at least a 1 -year period prior to the
official 90-day review date. These records may also serve
as a source of documentation to substantiate potential vio-
lations discovered through review of other records.
In order to effectively complete the production date phase of
the PMN review, the inspector should ascertain all of the
designations used by company for the subject chemical
(including R&D designations) and its end use product(s).
These include chemical names, common names, trade
names, synonyms, proprietary designations, in-house
jargon, acronyms and so on, so as to be fully alert to any of
these references when they occur in other records under
review. Some of these names may be listed in the PMN
(Part 1, b, 4), while other designations may have to be
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VI-15
ascertained through interviews and review of other
company records and research files.
e. Notice of Commencement (NQC1
The TSCA PMN regulations [40 CFR 720.102(b)] state that
an NOC must be submitted to the U.S. EPA on, or no later
than 30 calendar days after the first day of such manufac-
ture 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 {May 13, 1983), should have had
submitted NOCs by that date (or within 30 days).
A company will be 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 (false
NOC) if it has submitted an NOC and no commercial
manufacture or import had actually been initiated by that
date.
The NOC phase of the PMN inspection will normally
constitute an extension of the overall PMN production date
review, as described earlier (see Part VI.3.A). The date of
first commercial production or import of a PMN chemical
should be established through company production or other
records review, which is then compared with the NOC date.
The NOC date can usually be determined from the most
recent NOC summary (example given as Figure VI-3) or
company correspondence with the Agency.
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VI-16
D. GENERAL INVENTORY COMPLIANCE
1.	Introduction
The General Inventory phase of the TSCA Section 5 inspection is
most important, as it is the most likely activity which may lead to a
§ 5 "Failure to Notify" violation, i.e., manufacture or import of a
commercial chemical that is not on the § 8(b) Inventory or is not
covered by an R&D or other specific exemption. All four regulatory
sites listed in Part C.1 should be verified for General Inventory
compliance, however, a facility dedicated solely to TSCA R&D
activities may have little potential for this type of violation. All
commercially manufactured (and imported) chemicals, raw
materials and isolated intermediates should be verified for TSCA
§ 5 compliance at every inspection site for the immediate past
5 years.
2.	Inspection Guidelines
Proper planning is the key to both the conduct and success of this
phase of the § 5 inspection. During the arrangement of the
inspection by telephone, the inspector should request that the
plant official(s) prepare a list of all currently manufactured (and
imported) chemicals, isolated intermediates and raw materials by
chemical name, trade name(s) and Chemical Abstracts Service
(CAS) Registry Number. Commercially manufactured and
imported chemicals dropped since May 1983 should also be
requested to be listed. Although the inspector cannot legally
require that this listing be prepared (it is not a regulatory require-
ment), he or she can strongly recommend its preparation on the
basis that the overall § 5 inspection will be greatly facilitated.
If the list has been prepared and is available onsite for the inspec-
tion, the next step will be to verify its accuracy and completeness.
This can usually be accomplished through review of inventory,
production, batch and sales records for the immediate past 5
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VI-17
years. For many chemical manufacturing, importing and
processing facilities, the December record for each year will be
cumulative, i.e., reflecting production, sales or inventory data for
the previous 11 months in addition to December, thus, yielding
summarized data for an entire year. Any chemicals identified on
the production, inventory or sales records that are not on the
prepared list should be noted and explained to the inspector's
satisfaction, preferably while at the site. Any potentially violative
chemicals volunteered by the company officials should be verified
(documented) for total production for the previous 5 years. All
customers that have received a chemical in question, as well as
the general use(s) of the chemical should also be fully identified
and documented while at the site.
Once the accuracy of the list has been established by cross-
checking with other records at the inspection site, the inspector will
need to ascertain whether or not the chemicals on the list are on
the TSCA § 8(b) Inventory (both open and closed portions). The
CAS Registry numbers are very important, because these
designations are the easiest to utilize for § 8(b) Inventory
verification. The chemicals in question can be confirmed as to
their open § 8(b) inventory status either manually via the printed
manuals3, or automatically through the "Chemicals in Commerce
Information System" (CICIS) database. Any listed chemicals not
found on the open § 8(b) inventory will then also need to be
searched on the closed or "confidential" portion of the Section 8(b)
Inventory, for which NEIC currently does not have direct access. If
possible, the chemical structure for any chemicals not found on the
open 8(b) inventory should be obtained from the facility (or their
supplier).
If the inspection report will be prepared within 30 days from the
time of the inspection, any chemicals not found on the open
inventory will be submitted with the report as an appendix, using
the established forms [Figure VI-4], so as to be subsequently
searched by the Office of Toxic Substances (OTS) via the
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VI-18
Figure VI-4
IMD INVENTORY SEARCH FORM
ncH Received 	/	/	|
ncn No. 	
ER No.
FROM:	DATE:
PHONE NUMBER:
Certified Statement- Yes No	CAS No. 	
CHEMICAL NAME f S )		STRUCTURE
SEARCH Of COMPLETE TSCA INVENTORY
WOV. ECVil EOHHUlfe
USE	COHP&HY W S.HC
INVENTORY REFERENCE (Inventory Form /)
inn pfspohse SECT Iqv
TSC1 Inventory Search Corp 1et*d 01
Ret- Placed "i Inventory;
PMN I Jtf tDMItaMt)
Notice of Commencement
n Not or Inventory.
Hlrval1d CAS number.
Valid CAS Nunber 1$ not equivalent
to jubnltted Chemical Name.
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VI-19
Office of Compliance Monitoring (OCM). If the inspection report is
anticipated to take more than 30 days, the chemicals in question
should be checked immediately upon return to the office for open
inventory listing and any necessary closed (confidential)
search(es) should also be requested via the established form
[Figure VI-4] through the OCM.
Complete CAS Registry information is to be obtained, if available,
for all chemicals to be searched by OTS. Any discrepancies with
facility-provided information should be resolved before sending a
request to OTS. No chemicals are to be searched by OTS solely
on a trade name, code name or commercial designation. The
report or memo should be treated as TSCA CBI if the list identifies
the company or facility and the original information was declared
TSCA CBI.
All TSCA § 8(b) closed inventory verifications will be reviewed by
the senior program chemist (or designee) to assure consistency of
chemical name, structure and other details related to
nomenclature.
E. SECTION 5(eV5(f) ORDER
1. Scope
Section 5(e) orders are issued by the Agency to provide restric-
tions that will minimize human exposure and/or environmental
release when insufficient information is available to fully evaluate
the potential hazards associated with a PMN chemical. Generally
a § 5(e) order is issued based on structure-activity relationship
(SAR), similarity to other known hazardous chemicals, and/or
potential for significant exposure or release. A TSCA § 5(f) order
is similar to the 5(e) order, except that there are enough data to
determine that there is an unreasonable risk associated with the
chemical.
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VI-20
There are many TSCA § 5(e)/5(f) orders in effect for which
commercial production has not been initiated and no NOC has
been submitted to the Agency. If no NOC is recorded as having
been filed, a § 5(e)/5(f) inspection will normally not be conducted.
A PMN inspection may be conducted, if appropriate; however, it
will not be the basis for a category I selection (see NAIS, Ch. III).
A full PMN review, including R&D and TME, if applicable, should
also be conducted in conjunction with any TSCA § 5(e)/5(f) order
inspection. The inspector must assure that he or she has a copy of
the final version of any § 5(e)/5(f) order, and not a "draft" version
that may have been prepared by Agency officials for negotiating
purposes.
2.	Inspection Sites
The TSCA § 5(e) or 5(f) order is to be inspected for compliance at
the manufacturing site or, if appropriate, where an imported
chemical is being processed.
3.	TSCA Section 5teV5ffl Order Elements
Most TSCA § 5(e)/5(f) orders include, but are not limited to the
following binding elements:
Testing trigger
Glove testing
~	Protective clothing, devices and controls
•	Employee training
Disposal
Labeling
Customer notification and compliance
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VI-21
4. Compliance Verification
A § 5(e)/5(f) order inspection will be most productive if the subject
chemical is actually being produced or processed at the time of
the inspection (i.e., so that use of required protective equipment
and controls can be fully evaluated). Thus, the inspector should
attempt to arrange the inspection during such activities. At a
minimum, the NOC should have been submitted by the company.
The following guidelines are provided to assist the inspector in
establishing compliance with the various components of a
§ 5(e)/5(f) order:
Testing Trigger
Some § 5(e) orders contain "testing triggers" as a
requirement. If a certain yearly production (or import) vol-
ume of the subject PMN chemical is reached (i.e., the
"testing trigger"), then the company must curtail manufac-
ture and/or import, and initiate certain testing, as specified
in the Order. Testing may be for determination of health
effects, environmental impact, chemical fate or all three.
The inspector must establish total production and/or import
volume for the PMN chemical of interest and determine if
the specified testing trigger volume has been attained or
not. If the figure was reached, then the inspector will need
to verify that production (or import) had ceased and that
specified testing had been initiated if future manufacture (or
import) is anticipated. The initiation or completion of testing
should be documented, including the identification of the
testing laboratory or laboratories, the anticipated starting
and completion dates, and whether the tests were (are) to
be conducted according to the Good Laboratory Practice
(GLP) Standards regulations.
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VI-22
If testing has been initiated, it should also be ascertained by
the inspector whether any preliminary and/or final reports
have been received from the testing laboratory and whether
they have been submitted to the Agency. Unsubmitted
reports should be reviewed (and copies taken as exhibits, if
necessary) to determine if there was a potential TSCA
§ 8(e) substantial risk violation.
Glove Testing
Most TSCA § 5(e)/5(f) orders contain a requirement that the
company or facility test protective gloves for imperviousness
to the PMN chemical. The scope of this testing has been
put forth as an updated Agency Inspection Guideline, dated
May 1985 [Appendix D],
The inspector should document if, when and by whom, such
testing was performed, and whether it was conducted
according to the Agency's criteria. A copy of the glove
testing report or summary for the PMN chemical should be
collected and attached to the inspection report.
The inspector should also verify and document, if
necessary, that protective gloves were actually being used
by employees during production, handling, transfer and/or
processing of the chemical in question, and were identical
or equivalent to those that were tested for imperviousness.
Protective Clothing. Devices and Controls
Almost all § 5(e)/5(f) orders carry a requirement that certain
protective clothing and devices be worn by workers and
other personnel coming into contact with the PMN chemical.
To a lesser extent, safety and/or environmental controls on
production-related equipment are required. A key aspect of
the TSCA § 5(e)/5(f) order inspection will be to determine if
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VI-23
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).
To effectively determine compliance with this aspect of a
§ 5(e)/5(f) order, the inspection should be conducted when
the subject PMN material is actually being manufactured (or
processed, in the case of imports). The use of protective
clothing, devices and controls can be observed directly and
noncompliance documented accordingly. If the PMN mate-
rial has been manufactured (or processed), but not during
the onsite inspection, production employees (and others, if
necessary) should be interviewed to ascertain if the
required protective clothing devices were in full use.
When interviewing production personnel, the inspector
should advise both the company management and the
individual(s) to be interviewed, that employment rights are
protected under § 23(a)(3) of TSCA. This section of TSCA
states that it is unlawful for a company or employer to
discharge or otherwise discriminate against an employee
who assists with or participates in any Agency action
proceeding or intended to ascertain compliance with TSCA.
Employees should be interviewed in private, if possible;
however, company officials or their legal representatives
may wish to participate, which is not restricted by the statute
or regulations.
If protective clothing and/or devices are not being (or have
not been) worn, as required by the § 5(e)/5(f) order, then the
inspector will need to determine: (1)if the clothing and
equipment have not been made available (along with
training); (2) the clothing and equipment have been made
available, but are not being used; or (3) the clothing and
equipment have been supplied, but proper training for its
use has not been provided (see following Section D). If any
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VI-24
of these three situations are found to be the case during the
inspection, the inspector should attempt to obtain a signed
statement from the employee(s), or alternatively obtain a
signed statement from a responsible management official.
If a second member of the inspection team is present and a
signed statement cannot be obtained, the employee's or
manager's interview replies should be noted in the field
notebook, signed by the interviewing inspector and signed
by the second team member as witness.
Lack of control devices or employment of engineering
pradices contrary to the letter, intent or spirit of the 5(e)
order should be documented by photographs, if possible, or
signed statements from knowledgeable or responsible
individuals.
Employee Training
Most TSCA § 5(e) orders specify training in the handling of
the subject PMN substance(s) as well as the use of
protective clothing and devices. This training is to be
documented and completed by all involved employees prior
to initiation of manufacturing and/or processing of the PMN
chemical(s) described in the order.
If training has been provided by company management with
respect to a PMN chemical subject to a § 5(e)/5(f) order, a
prospectus of the training and a list of attendees must be
available for review. The extent of the training and list of
attendees should be verified against the § 5(e)/5(f) order
requirements and through employee and management
interviews. Any commercial production of the chemical that
is subject to the order which has taken place prior to the
date of the training session should be substantiated with
dated copies of documents related to the training, as well as
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VI-25
with documentation of the first date of commercial
production.
Disposal
If the TSCA § 5(e)/5(f) order contains requirements for
disposal of waste, excess and/or unsold chemical, then
actual disposition of all waste for the designated PMN
chemical should be determined. 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. Fugitive emissions and/or
other uncontrolled wastes should also be documented to
the degree possible.
Labeling
The TSCA § 5(e)/5(f) order will normally contain a
requirement for container labeling of the subject PMN
chemical, advising customers of the potential health and/or
environmental hazard associated with the chemical.
Preferably, the warning should be on the product label, in
correspondence, on records related to the shipment, and/or
via a Material Safety Data Sheet (MSDS) accompanying
the shipment.
The labeling should be determined for all shipments of the
subject chemical(s) sent to customers, to the degree
possible, particularly those ready for shipment. Bin labels,
photographs of actual labels of materials released for
shipment and copies of correspondence and shipping
records should be obtained to document noncompliance
with § 5(e)/5(f) order requirements. Written statements from
company officials and/or shipping personnel should also be
obtained, if appropriate.
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VI-26
Customer Notification and Compliance
TSCA 5(e)/5(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 § 5(e)/5(f) order and that certain precautions are
to be taken with the handling of the chemical. Normally, this
notification 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. Records are required to be
kept by the company designated in the order that document
the fulfillment of this obligation. Compliance with these
requirements should be ascertained for all commercial
shipments of the PMN chemicals subject to the § 5(e)/5(f)
order. If this requirement was not met, written statements
should be obtained from company officials as to whether
they were knowledgeable of the requirement and/or why it
was not followed.
F. TEST MARKETING EXEMPTION (TME\
1.	Scooe
TSCA § 5(h)(i) authorizes EPA to provide an exemption for
manufacturers who produce or import new chemicals for test
marketing purposes if they do not present any unreasonable risk
to health or the environment. This exemption must be applied for
with the Agency; it is not automatic. 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.
2.	Inspection Sites
To ascertain TME compliance, usually the manufacturing (or
importing) site will be the appropriate facility to inspect; however,
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VI-27
an R&D laboratory or pilot-plant may also be sites of production for
TME chemicals. The required TME records may also be available
(or can be made available) at a corporate headquarters office.
3.	TME Elements
The following elements generally constitute the essential compo-
nents of a TME that will require compliance verification during an
inspection, as appropriate:
Recordkeeping requirements
Chemical identification and structure
Health and environmental effects testing data
Period of applicability
Maximum volume and number of customers provided in
TME application
Description of the test market activity, i.e., use(s)
EPA imposed restrictions
4.	Compliance Verification
In general, all of the above listed elements wilt be reviewed for
compliance. Any additional elements or EPA requirements are
also to be verified, as appropriate. The following guidelines
should be consulted as necessary to verify compliance with the
various aspects of a TME application and its implementation:
Recordkeeping
The § 5 TME recordkeeping requirements specify the
retention of records to document the accuracy of the infor-
mation contained in the TME application and to document
adherence to the TME specifications. Failure to keep any of
these records is a violation of 40 CFR Part 728.78(c).
Although a company may have all of the required informa-
tion, the supporting records may be consolidated by the
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VI-28
company in one file at one facility or they may be distributed
at different production sites. Consolidation of these records
for review should be encouraged during the arranging of
any inspection involving a TME.
The inspector, however, should not accept at face value the
TME records, as provided by the facility. He or she should
ascertain all of the names and designations for the TME
chemical and be alert to its mention in any other records
and data reviews, as well as being observant to its
potentially illegal manufacture, sale, storage or use during
the plant tour and employee interviews.
Chemical Identification and/or Structure
The identity (structure) of the chemical actually produced
(imported) and sold during the TME period shall also be
verified against information and/or data contained in the
application. Quality control analyses of the batch(es)
produced during the TME period are to be compared with
those supplied with the TME application or generated
during R&D testing. These analyses may be in the form of
infrared (IR), nuclear magnetic resolution (NMR), mass (MS)
or ultraviolet (UV) spectra or as some form of gas, liquid or
thin-layer chromatography. If there is any doubt by the
inspector, the data should be collected and reviewed by
one of the program chemists. This analytical data for one or
two batches should be randomly checked, and the
remainder considered satisfactory, if there is accurate
correlation.
Health and Environmental Testing Data
The regulations [40 CFR Part 720.38(b)(1)] require that all
health and environmental testing data be supplied to the
Agency as part of the TME application. This requirement
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VI-29
also includes the results of all determinations of chemical
and physical properties. Thus, R&D files, notebooks and
benchsheets for TME chemicals should be reviewed to
ascertain if all testing data were submitted with the TME
application. Copies of any documents discussing structure-
activity relationships or analogue data that were not
included with or referenced in the application are also to be
collected as to document a potential violation. The dates of
such unsubmitted data or information should be reliably
documented to verify that these critical data were generated
or available prior to the TME submission.
Period of Applicability
The inspection should verify through review of general
production, batch, inventory and sales records that all
commercial manufacture or import of the TME chemical was
accomplished during the period of time designated in the
TME application. Deviations should be documented with
copies of appropriate records and/or signed statements
from company officials.
Maximum Volume and Number of Customers of the TME
Chemical
When reviewing inventory, batch and sales records for a
facility, TME records are to be verified whenever possible,
against these other sources. Thus, the inspector should
become familiar with all trade, generic and code names of
the TME chemical, including processed materials in which it
was used. Total volumes and customer distribution
obtained through inventory, batch and sales records should
agree with those in specific TME records. Any deviation,
particularly production volume or number of customers
beyond that specified in the approved TME application, is to
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VI-30
be thoroughly documented and supported with copies of
appropriate records.
Description of Test Marketing Activity
The TME application should be carefully reviewed
regarding the proposed use(s) and other activities for the
subject chemical. Correspondence, shipping and sales
records, and other pertinent files should be reviewed to
assure that the use, processing, final products and potential
exposure do not exceed that stated or implied in the TME
application. This should also be verified through employee
interviews, particularly with the technical contact. Potential
violations are to be documented with copies of records and
signed statements, as necessary.
EPA Imposed Restrictions
Any EPA imposed restrictions or limitations will also be
verified for compliance during the inspection. The inspector
cannot rely solely on the TME application to establish
compliance. All additional correspondence with the Agency
should be reviewed and discussed with the OTS Notice
Manager, if necessary. Most restrictions relate to reductions
in the proposed production volume, number of customers or
time period of applicability; however, other limitations also
may apply. Potential violations are to be documented in
similar fashion as that for other TME deviations.
G.	LOW VOLUME. POLYMER AND FAST FILM EXEMPTIONS
(To be completed)
H.	POLYMER EXEMPTION
(To be completed)
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SIGNIFICANT NFW USE RULE (SNUffl
(To be completed)
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Vll-1
VII. TSCA SECTION 8 INSPECTIONS
A.	BACKGROUND
A TSCA § 8 inspection will normally be conducted in conjunction with
each § 5 inspection and include compliance review for the following
recordkeeping and reporting requirements, as appropriate:
§ 8(a) Level A Preliminary Assessment Information Rule (PAIR)
report verification
§ 8(b) Inventory status, particularly Inventory Update Rule (IUR)
reporting
§ 8(c) Significant adverse effects recordkeeping
§ 8(d) Unpublished health effects reporting
§ 8(e) Substantial risk reporting
Specific guidelines for ascertaining compliance with each of these areas
at a facility are given in the following sections. Additional guidance and
policy are also given in Appendices F through J, respectively. The U.S.
EPA Penalty Policy for § 8 violations is given in Appendix B. All
potential TSCA § 8 violations should be documented to the extent that
all penalty policy required elements are fully addressed.
B.	TSCA SECTION 8(a) LEVEL A PAIR REPORT COMPLIANCE
EPA Headquarters guidance with respect to § 8(a) Level A compliance
is given in Appendix F.
The TSCA § 8(a) Level A reporting requirements are addressed within
the Chemical Information Rules (40 CFR 712), specifically under
Subpart B - the Preliminary Assessment Information Rule (PAIR).
Manufacturers and/or importers are required (unless exempt) to report
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VII-2
various production and use statistics for designated periods, as well as
worker exposure hours. Chemicals to be reported are selected from the
§ 8(b) General TSCA Inventory either by the Interagency Testing
Committee (ITC) or the Agency itself. The PAIR report will likely be
eventually replaced by the more detailed Comprehensive Assessment
Information Rule (CAIR) report. The PAIR does not require reporting
facilities to retain records or documentation with respect to submitted
information, nor does the rule cover processors or users; however, the
CAIR will require maintenance of such documentation and processors
and/or users will also be required to report.
Generally a § 8(a) Level A inspection will consist of two phases, both of
which should be completed as part of any overall TSCA § 5/8 compli-
ance inspection.
Phase I: Verification of production, disposition and worker exposure
for submitted PAIR reports
Phase II: Verification that all chemicals manufactured or imported by
the facility; which are listed in the Chemical Information Rule,
have been reported within the specified time frame, unless
the facility or the manufacturer (or importer) is exempt
In order to effectively complete the first phase of a § 8(a) Level A
inspection, official copies (from Agency files) of each plant's PAIR reports
should be made available to the inspector for review prior to the inspec-
tion. This completed form should be verified at the plant site for overall
accuracy, based on information obtained from company records, inter-
views and, if necessary, during the plant walk-through. To accomplish
Phase II, the facility general inventory chemical (manufactured and
imported only) list from the § 5 inspection is to be checked to ascertain if
any § 8(a) Level A chemicals are listed for which PAIR reports were
apparently not submitted. Phase I may occasionally be difficult to
accomplish, as specific record maintenance or other documentation of
PAIR information is not required by TSCA; however, Phase II compliance
should be readily ascertainable based on review of the general inventory
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VII-3
list, and/or comparison with routine production, batch, sates or import
records.
CAIR report compliance inspection guidelines will be developed when
the final rule is promulgated, since recordkeeping and the extent of
information to be reported will vary substantially from that of the PAIR
report.
Phase I
The key figures to be verified during the § 8(a) Level A inspection
are in Section IV, Part A, Items 1 and/or 2 of the PAIR report, the
amounts of the designated chemical imported or manufactured,
respectively. This (these) volume(s) should be verified through
comparison with production and/or batch records for the
applicable reporting period (previous complete corporate fiscal
year). The reported figures may have been estimated based upon
or derived from other information. Whatever the basis, the
inspector should verify to his or her satisfaction that the reported
values are reasonably accurate; significant deviations (greater
than 20%) from the PAIR reports are to be documented either with
copies of pertinent records and/or a signed statement from a plant
or corporate official.
The remainder of the information in Section IV, Parts A and B,
should also be verified to the degree possible, and any notable
(greater than 50%) deviations from the reported values should be
documented. Worker exposure hours should be verified via time
sheets or through personnel levels observed on the walk-through.
The "open" categories (4c, 5c, 6c and 7c) values are also to be
given special attention, as these data represent the primary points
of potential human exposure. Significant discrepancies (>50%
from reported values are to be documented either through copies
of records and/or statements from company officials.
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VIM
Phase il
Phase II of the TSCA § 8(a) Level A inspection will normally be
conducted in conjunction with the § 5 General Inventory stage of
the overall inspection, specifically as part of the review of
manufactured and/or imported chemicals for TSCA § 8(b)
inventory status. A § 8(d) review (see Section VII.E) will also
normally be conducted in conjunction with the second phase of
the § 8(a) Level A inspection.
Before the onsite visit, the inspector should establish, if possible,
which § 8(a) Level A PAIR reports have been submitted by the
facility. Submittals can usually be ascertained from the various
periodic database summaries received by NEIC from the
Information Management Division of OTS, however, errors of
omission have been found with these listings. The § 8(b) existing
chemical inventory (CICIS report) can also be used to identify
suspect chemicals; however, it must be kept in mind that this
§ 8(b) inventory listing reflects 1978 production activity and that
there are specific exemptions from PAIR reporting (see 40 CFR
712.25).
The list of manufactured and/or imported chemicals (from the § 5
general inventory phase of the inspection) should be checked
either manually or via data system against the latest Chemicals on
Reporting Rules Summary (CORRS) report. Any production for a
chemical found on the prepared list, for which a PAIR report was
not submitted and which was manufactured and/or imported
during the designated reporting period (also given in the CORRS
list and in 40 CFR 712.30), is to be further documented. If
production or import for an § 8(a) Level A chemical occurred
during the appropriate period, copies of records should be
obtained regarding total volume of chemical involved and
estimated worker exposure hours.
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VII-5
If the company has claimed a § 8(a) Level A exemption (R&D,
low-volume or small business), this exemption should be
substantiated through review of supporting records and other
documents, including an independent Dun & Bradstreet report to
support any claims for a small business exemption. If the
company management indicates they are submitting a late PAIR
report as a result of the inspection, the inspector should request
that a dated copy be submitted to you as the inspector, for
inclusion with the inspection report.
TSCA SECTION 8(b) INSPECTION
(To be completed)
Draft Headquarters inspection guidelines for § 8(b) are given in
Appendix G.
T5CA SECTION 8(c) INSPECTION
Headquarters inspection guidelines for § 8(c) are given in Appendix H.
Generally, the TSCA § 8(c) inspection will consist of four phases, three
for which noncompliance can result in an enforcement action; the fourth
will normally be educational. The three aspects of § 8(c) which may
result in administrative, civil or criminal penalties are:
Failure to record allegations
Failure to keep allegation records, as required
Failure to retain records the required length of time
These phases are elaborated on as follows:
Failure to Record Allegations
The most significant noncompliance with TSCA § 8(c) will be
failure to record allegations of previously unknown significant
health or environmental effects. Since nonrecorded allegations
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VII-6
are difficult to establish, several alternative record files should be
reviewed, if available, at a facility as part of any § 8(c) inspection.
These include, but are not limited to:
Incident files
Spill or release records
OSHA 200 and/or 101 records
Consumer complaint files
Safety records
General employee medical and health records
Tips and/or complaints from employees, nearby residents, state
and local regulatory officials or other concerned parties may also
identify suspect non-recorded § 8(c) allegations.
If any incidents or situations are found in these other files or
records that appear to meet the criteria for a § 8(c) allegation,
then further action by the inspector will be necessary. All facts
should be ascertained regarding a potential nonrecorded allega-
tion, particularly with respect to name(s), date(s), symptoms and/or
effects, the chemical, mixture or process involved, expert opinions
and company response. If possible this information should be
obtained from the alleging party via copies of correspondence or a
written statement. Copies of correspondence to company officials
that relate to a potential nonrecorded allegation are the primary
documentation source. Complete documentation is critical, partic-
ularly with respect to the symptoms or effects, as it is likely that the
Agency will be required to make an expert scientific finding as to
whether or not the effect was previously unknown. At a minimum,
the Material Safety Data Sheet (MSDS) for any § 8(c)-related
chemical should be obtained.
Upon return to the office, additional standard toxicological
references and databases (e.g., Toxline) are to be searched for
the chemicals or processes involved for any effects not apparent
from literature or other records collected at the site.
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VII-7
If at all unsure of a potential § 8(c) situation, all facets regarding a
potential nonrecorded allegation should be presented and docu-
mented in the final inspection report for OTS review.
Failure to Keep Allegation Records as Required
40 CFR 717.15(a), (b) and (c) specify the file location, content and
structure of any § 8(c) allegation on file by the company. The
records are required to be kept at the corporate headquarters or
"any other appropriate location central to the firm's chemical
operations." Generally this requirement will not present an
inspection problem, as corporate records can normally be
transmitted to a facility for a specific inspection if enough lead time
is given. Of greater significance are the content and structure of
the specific § 8(c) files. The § 8(c) files are required to be
retrievable by chemical, process or emission, not by the alleging
person, building or other designation. If improper filing is
apparent, the file folder heading (or printout) should be copied for
documentation of potential noncompliance, along with the specific
contents to verify that the file in question contains one or more
§ 8(c) allegations.
The content of each § 8(c) allegation on file should be determined
to be complete with respect to the following regulatory
requirements:
Original allegation and abstract
Name and address of the plant or facility which received the
allegation
The date the allegation was received
The implicated substance, mixture, article, process, opera-
tion or site discharge
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VII-8
Description of the alleging party (i.e., company employee,
consumer, neighbor or other)
Description of the alleged health effect(s), including how
effect(s) became known and the route of exposure. Also
sex and date of birth of affected party.
Description of the nature of the environmental effects,
identifying the affected plant and/or animal species, or
contaminated portion of the physical environment.
Results of any internal or company investigation regarding
the allegation
Copies of any further required records or reports (e.g., EPA,
OSHA, State or CPSC records).
If any of the above elements are missing, incomplete or inaccu-
rate, the entire § 8(c) file for that allegation (and others as appro-
priate, for comparison, etc.) should be taken as documentation to
substantiate the suspect violation. The title on the file folder
should also be documented. Additional facts, records, statements
and/or observations should be taken, as appropriate, to establish
the gravity of harm associated with the incomplete or inaccurate
§ 8(c) file.
Failure to Retain Records the Required Length of Tims
40 CFR Part 717.15(d) specifies retention of employee health
records for 30 years and for a period of 5 years for all other types
of allegations. Thus, all 8(c) allegations on file at a company or
plant site must be noted and/or documented (copied) for accurate
evaluation or compliance with retention requirements during future
inspections at the same facility or company.
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VII-9
On subsequent re-inspection of a plant site or other location where
§ 8(c) records are kept, the inspector will be responsible for
assuring that the previous listing or copies of allegations derived
from any previous inspection(s) are reviewed, if available. Any
§ 8(c) allegations that appear to be missing or altered should be
documented and/or investigated accordingly. If the original miss-
ing or altered allegation involved an employee of the inspected
company, then an attempt should be made to interview that
employee (or relatives or associates) to ascertain his or her recent
medical history and other facts that may pertain to the missing or
altered files. Criminal referral may be warranted if knowing or
intentional alteration or destruction of § 6(c) records is suspected.
Company Awareness/Aoencv Outreach
This phase of the § 8(c) inspection will not likely lead directly to an
enforcement action; however, it may have a large impact on
industry compliance. An effective outreach program by the NEIC
inspectors should lead to an increased level of timely § 8(c)
substantial risk submissions. In general, the large chemical
corporations will have company-wide policies and procedures
regarding TSCA § 8(c); however, smaller companies (and even
outlying or remote facilities for larger companies) will generally
have minimal awareness of § 8(c) requirements, unless they have
been previously inspected.
The following points should be covered to determine the aware-
ness of facility management to § 8(c):
• Are management officials knowledgeable of TSCA § 8(c)
and its associated regulations? Is there a copy of the
Statement of Interpretation on file at the facility?
Is there a person identified as being responsible for
handling and/or reviewing § 8(c) information and filing
§ 8(c) allegations? (Obtain this person's name and title.)
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VII-10
Does the company and/or facility have an internal § 8(c)
policy and/or procedures document on file? Have they
been followed for any actual or potential § 8(c) allega-
tions? (Obtain copy of policy/procedures for report exhibit,
as required by the Headquarters inspection guidelines.)
Do employees other than management appear to be
knowledgeable of TSCA § 8(c)? Has the policy document
been posted and/or distributed to all employees? Has
§ 8(c) been discussed at safety, union or other general
employee meetings?
Based on the company's apparent awareness, sufficient
effort should be put forth by the inspector to assure that the
management and/or regulatory officials have a reasonably
clear understanding of their obligations under TSCA § 8(c).
Copies of the regulations and fact sheets are to be left with
management officials, as appropriate.
E. TSCA SECTION 8
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VII-11
along with dates and titles of studies that appear to have been published
in the scientific literature or otherwise submitted to the agency. Studies
that appear to have met the criteria of § 8(d), but which company records
or officials indicate have not been submitted, should be copied and taken
as exhibits. Likewise, inquiry should be made with respect to any
ongoing testing of § 8(d) chemicals. Physical/chemical testing should
also be verified as to Agency reporting to the extent required by 40 CFR
Part 716.10.
TSCA § 8(d) chemicals are listed on the Chemicals on Reporting Rules
(CORR) database. The latest version of this document is to be taken on
all inspections for ready reference. It lists all chemicals in the § 8(a)
Level A and § 8(d) rules as well as those subject to Significant New Use
Rules (SNUR) and Section 4 test rules.
F. TSCA SECTION 8fa) SUBSTANTIAL RISK REPORTING
EPA Headquarters guidelines with respect to § 8(e) compliance are
provided in Appendix J.
TSCA § 8(e) substantial risk reporting requirements were self-
implementing upon the effective date of TSCA on January 1, 1977; there
are no regulations or rule-making given in the Code of Federal
Regulations. An Interpretive Statement [Appendix K] was issued by the
Agency in 1978 (Fed. Reg. 43, No. 32, p. 11110, March 16) which
defined "substantial risk," identified persons subject to the requirement
and provided other pertinent details associated with § 8(e). No
recordkeeping by affected parties is required by this section of TSCA.
The three potential violations that may result from a § 8(e) compliance
inspection (or investigation) are:
Failure to report or falsification of a report
Failure to report on time
Failure to follow prescribed reporting procedures
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VII-12
In addition, company awareness of TSCA § 8(e) shall also be
determined as part of any TSCA § 8 inspection.
In general, § 8(e) reports submitted by the chemical industry will derive
from two sources: (1) Results from human, animal and environmental
studies conducted on chemicals, mixtures or effluents; and (2) incidents
involving chemicals, mixtures, effluents or processes. Consumer com-
plaints may also result in (or require) a §8(e) submission; however, so
far few have been submitted to the Agency that have derived from this
source.
Generally the § 8(e) inspection will be conducted in conjunction with the
§ 8(c) review.
The different phases of the TSCA § 8(e) inspection are addressed as
follows:
Failure to Report or Falsification of a Report
This phase of a § 8(e) inspection will usually be conducted
through interviews with company officials, and reviews of records
and documents from three sources:
Ongoing and completed health effects, environmental
impact and chemical fate studies
Epidemiology, monitoring and other workplace survey
studies
§ 8(c) records, incident records, complaint files, OSHA
records and safety and health records
To date, health effects studies have been the primary source of
TSCA § 8(e) reports to OTS.
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VII-13
The inspector should request all of the above listed reports or
records that may potentially contain § 8(e) information to the
degree they have been maintained and are readily available. Pre-
inspection arrangements should be made for transmittal or copies
of studies (or at least summaries) for studies known by company or
regulatory officials to have been conducted on chemicals pro-
duced at the plant site, but for which copies are not locally avail-
able. Generally, health and environmental studies will have been
conducted under contract by the corporate headquarters or at the
corporate research or testing facility.
Occasionally, a § 8(e) reporting situation may be uncovered as a
result of a TSCA § 4 or § 5 Good Laboratory Practice (GLP)
Standards inspection, conducted by the Agency at either a
commercial, in-house or academic testing facility. Thus, the GLP
inspector should follow up accordingly if such a situation arises,
and seek out the earliest interim or preliminary report or summary
in which the deleterious effect is noted. Unless company officials
produce satisfactory evidence that a § 8(e) report was submitted,
the inspector should assume that it was not, and document his or
her findings accordingly.
Failure to Report on Time
According to the § 8(e) Interpretative Statement [Appendix K], a
company (or company official) has to file an emergency incident
report by telephone immediately (generally within 24 hours), and
has 15 working days in which to file a written report for a
nonemergency health or environmental substantial risk situation.
This phase of a § 8(e) inspection will be most appropriately
completed when inspecting a corporate headquarters facility,
since most substantial risk reports will be submitted from this
company site. Incident related reports may be derived either from
a plant site or a corporate headquarters location.
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VII-14
Thus, in order to complete this phase of the § 8(e) inspection, the
inspector should make him- or herself knowledgeable of all § 8(e)
reports submitted to the Agency by the company, prior to a
planned inspection. However, it has proven very difficult to
acquire any sort of site-specific or otherwise meaningful § 8(e)
information from OTS; thus, the best source of this information has
generally been the inspected facility itself. Consequently, during
the planning and arranging the inspection, the inspector must
emphasize to the company officials that copies of all pertinent
TSCA § 8(e) reports and supporting documentation related to that
facility (or that facility's manufactured and/or imported chemicals)
are to be made available during the inspection.
The key aspect of this phase of the § 8(e) inspection is the deter-
mination of the date company or knowledgeable officials first
became aware of the substantial risk situation. The inspector
should request and examine all records, correspondence and
data to determine if the 15-working-day (or 24 hours for emergen-
cies) deadline was met. For longer term health and environmental
studies, interim and/or preliminary reports are good sources to
review, as harmful effects may be documented as having been
observed by knowledgeable persons well before the completion of
a study (and the preparation of a final report). If earlier harmful
effects are suspected to have been observed in such cases,
copies of the interim report(s) and other supporting evidence
(correspondence, laboratory notes, etc.) should be taken as
evidence to support the late submittal. Other potential sources are
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 § 8(e)
report has been submitted.
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VII-15
Failure to Follow Prescribed Reporting Procedures
Generally, a violation of this nature will be self-evident from the
submittal itself, in that the § 8(e) was: (1) sent to the wrong office
or address; (2) did not contain complete information, as required
by the Interpretative Statement; and/or (3) did not contain a sum-
mary. Inspections involving these issues will usually involve only
a routine compliance verification; however, OTS may request a
specific followup inspection with respect to the filing of incomplete
information by a company.
Company Awareness/Aaencv Outreach
This phase of the § 8(e) inspection will not likely lead directly to
an enforcement action; however, it may have a large indirect
impact on industry compliance. An effective outreach program by
the NEIC inspectors should lead to an increased level of timely
§ 8(e) substantial risk and related "For Your Information" (FYI)
submissions. In general, the large chemical corporations will have
company-wide policies and procedures regarding TSCA § 8(e),
however, smaller companies (and even outlying or remote facili-
ties for larger companies) may need to develop and implement
such policies.
The following points should be covered during the inspection to deter-
mine facility management's awareness of § 8(e).
Are the management officials aware of TSCA § 8(e), the legal
requirements and/or the Statement of Interpretation? Is there a
copy of the Statement of Interpretation on file at the facility?
• Is there a person identified as being responsible for handling
§ 8(e) information and submitting § 8(e) reports or § 8(e)
information to other corporate officials? (Obtain this person's
name and title.)
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VII-16
Does the company and/or facility have an internal § 8(e) policy
and/or procedures document on file? Has it been followed for any
actual or potential § 8(e) reports or "For Your Information" (FYI)
submittals? (Obtain copy of policy/procedures for report exhibit as
required by the Headquarters inspection guidelines.)
Does the policy adequately define corporate responsibility so as to
relieve employees of individual responsibility to report? Do
employees other than management appear to be knowledgeable
of TSCA § 8(e)? Has the policy document been distributed to all
employees? Has § 8(e) been discussed at safety, union or other
general employee meetings?
Does the company perform its own health effects, environmental
impact, epidemiology and/or workplace monitoring studies, or are
these performed under contract? (Obtain as much information as
possible on completed studies, ongoing studies and testing
facilities involved.)
Based on the company's apparent awareness, the inspector should put
forth sufficient effort to assure that the management and/or regulatory
officials have a reasonably clear understanding of their obligations under
TSCA § 8(e). Copies of the Statement of Interpretation, fact sheets and
other helpful information may be provided to the officials, as appropriate.
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VIII-1
VIII. INSPECTION REPORT PREPARATION
A.	INTRODUCTION
The purpose of this section is to guide the inspector in the preparation of
a clear, concise and complete description of the conduct, findings and
conclusions for TSCA § 5 and § 8 inspections; thus, NEIC inspection
reports are to be prepared according to the format described herein to
the degree possible and applicable. Proposed significant deviation(s)
from the format described herein shall be discussed with supervisory
personnel.
B.	TIMELINESS
The report shall be prepared in a timely fashion in order to expedite any
necessary followup and/or enforcement actions which might arise from
the inspection. The inspector shall make every effort to complete the
report within 45 days of the inspection. If this schedule cannot be met,
the inspector shall notify the supervisor of the reason for the delay, the
anticipated date of completion of the report, and keep the supervisor
advised of any additional delays.
C.	REPORT FORMAT
The preferred format for the report shall be a narrative summary and
detailed report, as described in Section E below. However, a worksheet
[Appendix L] may be used, if desired, for inspections in which: (1) no
potential violations were found; (2) the inspection was not in response to
a tip, complaint or referral; and (3) the report would not otherwise be
transmitted to OCM/OTS for further review. If the worksheet is utilized, a
narrative summary shall still be prepared, as described in Section VIII.E.3
for transmittal for NEIC files and Freedom of Information (FOI) purposes.
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VIII-2
D.	FORMAT - WORKSHEET
The short report or worksheet format [Appendix L] shall be used only
when all of the previously mentioned conditions are met for a completed
inspection. Section I and II of the worksheet shall be prepared for every
inspection. Other sections shall be completed, as appropriate, depend-
ing on the type (components) of the inspection conducted. All necessary
exhibits shall be attached and be identified by number on the worksheet
and on the exhibit list. Any necessary tables shall likewise be identified
by number in the worksheet and attached. Short form worksheets are to
be reviewed as described in Section Vlll-F, and handled by the internal
security procedures described in Section Vlll-G of this manual.
E.	FORMAT - FULL NARRATIVE REPORT
Any full narrative reports shall be organized in the following format:
Cover or title page
Headings
•	Summary
•	Inspection report (begin new page)
Conduct of inspection
Description of facility
Findings (and conclusions, if appropriate)
Signature(s)
•	Exhibits
These sections are further described as follows:
1. Cover or Title Page
The cover page shall be written in the format shown in
Figure VIII-1 and shall be attached to all reports.
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Figure VII1-1
EXAMPLE OF TITLE PAGE
VIII-3
TOXIC SUBSTANCES CONTROL ACT (TSCA) SECTION ft (or 5) INSPECTION REPORT
Petroleum, Oil and Gas Co.
Big Chief, Oklahoma
April 24, 19ftft
Dean F. Hill
National Enforcement Investigations Center
Denver, Colorado
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VIII-4
Headings
The following information shall be presented as a heading to the
report summary:
Company
Responsible Official
Date of Inspection
Inspectorate)
Full Company Name
Address
Mailing Address, if different
City, State and Zip Code
Telephone Number and Dun &
Bradstreet (DUNS) Number
Name and Title of person
receiving TSCA Notice of
Inspection
Name(s) and affiliation(s)
of inspector(s)
Summary
The summary shall be a brief outline of the full report. It shall
include the purpose for the inspection, a description of the conduct
(scope) of the inspection, a very brief description of the facility and
a summary of the findings.
Nonviolative: If the facility was deemed by the inspector to be in
compliance with TSCA regulations, no concluding statement is
needed. Chemical names, CAS numbers or PMN, TME, bona fide
or other numbers which uniquely identify a chemical should
normally not be included in this summary, so that it need not be
subjected to TSCA CBI classification. The summary should be
brief in nature. The summary will serve to fulfill most Freedom of
Information (FOI) requests. Separate summaries will be prepared
for the § 5 and § 8 inspection reports for each facility.
Violative: If a potential violation is detected for the § 5 and/or § 8
phase of the inspection, the summary shall identify the violation
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VI11-5
suspected, persons interviewed and records reviewed by the
inspector to confirm the violation, and any verification or followup
required of OTS. Detailed descriptions of the above points shall
be confined to the main body of the inspection report.
A conclusionary statement should also be given regarding the
nature of the potential violation(s).
4. Inspection Report
The main body of the inspection report will usually be divided into
three sections, consisting of a description of the conduct of the
inspection, description of the facility, and a discussion of the
findings and conclusions (for potential violations) of the inspection.
(a) Conduct of Inspection: This section will include: (1) Date
of initial telephone notification of inspection and full name
and title of facility official contacted; (2) date and time of
arrival of inspector at facility; (3) full name and title of facility
representative(s) to whom official credentials, TSCA Notice
of Inspection and TSCA Inspection Confidentiality Notice
were presented; (4) names and titles of all facility
personnel present during the opening interview;
(5) summary of any statements made by the inspector
concerning purpose for inspection, and (6) mention of any
other discussions that occurred or issues raised during the
opening interview.
Also included in this section shall be a one paragraph
summary of the scope of the inspection, including, if appli-
cable, a description of the type(s) of directed inspections
[i.e., bona fide, PMN, TME, Section 5(e) orders, PAIR or
CAIR reports, etc.] or general inspections [i.e., inventory,
Section 8(c)/(e), Section 8(a) Level A, etc.] conducted and a
description of the facility areas visited.
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VIII-6
The exit interview shall be described in this section of the
inspection report, including the names and titles of all
facility officials attendant at the exit interview and to whom
received the TSCA Receipt for Samples and Documents
and the TSCA Declaration of Confidential Business
Information-
(b)	Description of Facility: This section should include, where
applicable: (1) A description of its placement in the overall
corporate structure; (2) the corporate chain-of-command;
(3) a brief history of the facility; (4) products and services
provided by both the facility and the parent corporation;
(5) number of employees at the facility and their general
function and/or responsibilities; (6) approximate annual
gross sales in dollars; (7) the physical description of the
facility, including receiving, storage and shipping, manu-
facturing or processing, quality control, research and devel-
opment, pilot plants, administrative offices, etc.; and (8) any
other general or descriptive information which is pertinent to
the inspection. The senior official of the facility should also
be identified, if different from that individual to whom TSCA
Notice of Inspection was issued.
(c)	Findings and Conclusions: This section is to include a
discussion of the results of the inspection. Findings shall be
discussed for both undirected and directed inspections, as
applicable. All potential violations are to be identified by
relevant TSCA section and/or specific chemical.
Undirected Inspections: Undirected inspections include,
but are not necessarily limited to, § 8(c)/8(e), § 8(a)
Level A (general), and general inventory, i.e., those which
don't involve specific submittals or suspect nonsubmittals.
§ 8(c)/8(e) findings shall include: (1) A discussion of the
facility and/or corporate § 8(c)/8(e) written policies and/or
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VIII-7
procedures, with copies included with the report as exhibits,
if available; (2) all § 8(c) allegations on file at the facility;
(3)	any § 8(e) submissions originating from the facility;
(4)	any other pertinent information concerning facility
policy, recordkeeping or reporting under TSCA § 8(c)/8(e).
Any Agency § 8(c)/8(e) outreach, including informational
material, provided to facility personnel by the inspector shall
also be noted in this section of the report. The company's
general knowledge of § 8(c)/8(e) regulations should be
discussed in this section, including efforts given toward
promoting employee awareness.
General § 8(a) Level A and § 8(d) findings shall include a
listing of any chemicals (by name and CASR number)
which were produced by the facility and were subject to
PAIR, CAIR or § 8(d) reporting requirements. Any suspect
nonreporting of chemicals subject to the above rules shall
be reviewed for compliance in the usual manner, with
special attention to the stated or apparent reason(s) for
nonreporting.
General inventory (§ 5) findings shall include a listing of
any chemicals (by name and CASR number) which were
manufactured or imported by the facility, or which were raw
materials or isolated intermediates that could not be found
on the § 8(b) open inventory, if a confidential inventory
search has not been initiated for some reason. Production
volumes for the previous 5 years, along with evidence of
commercial use, shall also be provided. The inspector may
find it appropriate to summarize production information in
tabular format.
Directed Inspections: Directed inspections include review
of specific bona fide inquiries, PMNs, TMEs, § 5(e)/(f)
orders, § 8(a) Level A PAIR and CAIR reports, § 8(d) and
§ 8(e) reports, tips, complaints and referrals or any other
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VIII-8
specifically requested TSCA-related information. The
findings for these inspections are to be presented under
separate headings and organized in a clear and logical
order. Each chemical is to be discussed separately.
Include, if available, the scientific name of the chemical,
CASR number and any common names, generic names,
abbreviations, trade names and/or code numbers used by
the company to identify the chemical in its internal records
or communications with the Agency. Subsequent refer-
ences to the chemical can be made using a common name,
abbreviation or trade name rather than a CASR number or
Agency control number. The discussion is to include the
date of the submission to the Agency (bona fide, PMN,
NOC, TME, LVE, PAIR report, etc), and the nature and date
of any replies, written or oral, from the Agency. Communi-
cations with, or responses from, the Agency shall be
reported as completely as possible. Normally, any multiple
or complicated series of submissions for an individual
chemical will be reported in chronological order; however,
deviations from that order of presentation may be made, if
necessary, for the clarity of the report. Any of the above
information may be summarized in the form of a table, if
applicable.
The report shall fully describe all records reviewed during
the inspection, including the specific time period(s) covered
by those documents. This information is to be included
regardless of the compliance status of the company with
respect to the documents.
Any information included in the report which was provided
orally by company official(s) and which was not otherwise
verified, will be attributed to the official(s) by name.
Information obtained from the company which is used to
support potentially violative findings shall be included with
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VIII-9
the report as exhibits (see below), Exhibits are to be used
to support findings discussed in the report, not to substitute
for such discussion. If the information contained in an
exhibit is too lengthy to be included or easily referenced in
the text of the report, it should also be summarized in a
table. Tables shall be prepared as necessary to tabulate,
summarize or clarify information; however, the text of the
report shall explain the nature, purpose and significance.
Tables and figures shall be placed immediately following
the text, before the exhibits, or, if short, in the body of the
report. Tables shall be numbered consecutively, if there are
two or more tables. If there is only one table, it is not to be
numbered.
5.	Signatured
Reports will normally be signed and dated by all Agency
personnel that participated onsite with the inspection. Signatures
by any individuals who participated in a trainee/observer capacity
are not needed if they did not take an active role in the inspection.
Summaries normally need not be signed.
6.	Exhibits
The exhibits included with the inspection report will consist of a
copy of the notification letter, the four Agency administrative forms
and any other information which was provided by the facility to the
inspector and which was specifically mentioned by the inspector in
the reports. As noted above, exhibits are not to include any
abstraction or interpretation of information made by the inspector,
nor any information provided by the facility which is not addressed
in the text of the report. Generally exhibits are not to be included
which relate to routine findings of the inspection in which the
facility deemed to be in compliance; however, exhibits should be
included to answer all questions or concerns that relate to the
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VIII-10
substance of a tip, complaint or referral. Copies of the facility
§ 8(c) and 8(e) policies should always be included with the § 8
report.
Exhibits are to be placed at the end of the report. An Index of
Exhibits, listing all of the exhibits included with the report, shall
immediately precede the exhibits. The order of the administrative
exhibits and general format will generally be as follows:
Exhibit 1: Notification Letter
Exhibit 2: TSCA Notice of Inspection
Exhibit 3: TSCA Inspection Confidentiality Notice
Exhibit 4: TSCA Receipt for Samples and Documents
Exhibit 5: TSCA Declaration of Confidential Business
Information
All other exhibits will follow in the numerical order in which they
appear in the report. Each exhibit will be preceded by a
goldenrod-colored divider page which bears the exhibit number
and name of exhibit in the lower right corner.
REPORT REVIEW
Before being submitted for final review by the Branch or program
supervisor, all full narrative reports are to undergo peer review. This
review will generally be limited to clarity, conciseness, format, spelling
and grammar. After completion of the review and any necessary
revisions, the report will go to Branch supervisor (or designee) for final
review and entry into the tracking log. All non-narrative reports will be
handled the same way, except that the peer review step will be
bypassed.
SECURITY AND CUSTODY
Inspection reports shall be treated as TSCA Confidential Business
Information (CBI) or enforcement sensitive, as appropriate, at all stages
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VIII-11
of preparation and review. All CBI reports shall have a green CBI cover
sheet attached at all times, with the designation "DRAFT" written on it,
and for all transmittals of such reports between staff members (including
secretaries) will be conducted in conformance with CBI requirements.
H. EDITORIAL GUIDELINES
For the sake of uniformity in reports, the following guidelines should be
followed:
1.	Repetitive Sections: (i.e., CONDUCT OF INSPECTION and
NATURE OF FACILITY) Unless there is a reason to make
changes, they will normally be identical for both the TSCA § 5
and the § 8 reports. The typist may be instructed to use the same
discussions in each report; however, the author should ensure that
the TSCA statute Section number is correctly designated for each
report.
2.	Tables and Figures: If tables are included in reports, they should
be placed immediately following the text, just before the exhibits.
Alternately, if they are short, they may be placed in the body of the
report. They should not be attached as exhibits. If there is only
one table or figure, it should be listed as "Table" or "Figure", as
appropriate. Tables are numbered only if there are two or more in
the report. Tables and figures should be kept simple and only
necessary data are to be included. Complicated remarks and
footnotes should generally not appear in tables or figures, but may
be included in the text of the report.
3.	PMNs, TMEs, bona fides, etc., are documents, not chemicals. A
chemical should be referred to as "the PMN chemical" or "the
chemical described in PMN-87-0001," not as "the PMN."
4.	If a chemical is described by CAS registry number, a short
abbreviation or trade name should be given. The chemical should
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V111-12
be referred to in the report by its chemical name, abbreviation or
trade name, rather than by the CAS number. For example-
"1,3,5-trichlorobenzene (TCB), CAS No. 120-08-1" should
be used the first time the chemical is mentioned in the
report. It may be subsequently referred to as "TCB".
"toluene, CAS No. 108-88-3" may subsequently be referred
to as "toluene."
5.	When a number is used to identify a chemical, it should be
specified as being a bona fide number, a PMN number, a CAS
number, etc., in order to avoid confusion.
6.	The following format should be used for TSCA document
numbers:
PMN	P-86-0011
TME	T-86-0011
Low volume exemption (LVE)	L-86-0011
Polymer exemption (PE)	Y-86-0011
Note that four digits are used after the digits designating the year.
7. When a chemical name is used in the text of the report, it should
be capitalized only if it is the first word in the sentence and in that
case, only the first letter should be capitalized. The following
should never be capitalized: o(ortho), m(meta), p(para), n(normal},
i(iso), t(tertiary), or any other abbreviation which normally should
be lower case. The following should always be capitalized:
N(nitrogen), O(oxygen), P(phosphorus), S(sulfur), or any other
abbreviation which normally should be upper case. Examples:
First word in sentence:	In body of sentence:
1,2-Dichlorophenoxy acetic	1,2-dichlorophenoxy acetic
acid	acid
m-Dichlorobenzene	m-dichlorobenzene
Aniline	aniline
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VIII-13
n-Hexane	n-hexane
N-Methyl aniline	N-methyl aniline
i-Octane	i-octane
Isooctane	isooctane
In a table using chemical names, the first letter of the name should
be capitalized as described above.
8. Registered trade names should be capitalized according to the
usage of the company. They should be identified with a
superscript ® or TM, according to company usage.
9. Abbreviations used in the text should always be identified when
first used. This includes all Toxic Substances Control Act (TSCA)
terms. Examples are:
• Trichlorobenzene (TCB)
Gas chromatography (GC)
Research and development (R&D)
Bona fide intent to manufacture (bona fide)
Notice of commencement (NOC)
Premanufacture notification (PMN)
Rohm and Haas, Inc. (R&H)
Note: Bona fide is two words and should not be capitalized except
as the first word of a sentence.
10.	TSCA terminology should be correctly used, with attention given to
capitalization. The following is the correct usage and
capitalization:
notice of commencement (NOC)
premanufacture notice or notification (PMN)
bona fide intent to manufacture (bona fide)
test-marketing exemption (TME)
low volume exemption (LVE)
Chemical Abstract Services Registry Number (CAS # or
CAS No.)
11.	Company officials should always be identified by full name and
title when first mentioned: "Dr. John Q. Smith, Director, Product
Development." If a company official is present during the
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VIII-14
inspection who is visiting from a different company site, the site
location/affiliation should be noted: "Dr. John Q. Smith, Vice
President, Research and Development, XYZ Corporate
Headquarters, Philadelphia, Pennsylvania."
All typed draft reports must be carefully proofread by the author,
paying special attention to numbers (CAS, PMN, production
figures, etc.), dates, names of persons, companies, chemicals and
all spelling and punctuation. The author bears final responsibility
for the accuracy of the report.
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IX-1
IX. COLLECTION OF EVIDENCE
A.	BACKGROUND
The collection of defensible evidence that completely and succinctly
supports potential violations of TSCA § 5 or § 8 (or any other Federal
statue) is essential to the success of any enforcement action, whether it
be regulatory, administrative, civil or criminal in nature. Evidence may be
in the form of field notes, copies of records or data, documented
interviews or statements, photographs and/or physical samples.
Guidelines for these types of evidence are given in established
inspection and procedures manuals,'2 5 and are consolidated and
emphasized in this manual for ease of reference.
B.	FIELD NOTES
The field notes will be the single most important source of documentation
taken during an inspection. Field notes will always be taken in the
serialized black NEIC field notebooks ("Field Data Records") issued by
the Branch DCO. Each inspection team member will have his or her own
notebook and notes from no more than one company will be recorded in
a notebook.
The first page of the notebook should be identified with the inspector's
name, the facility, the date(s) and the NEIC inspection number. Any
business cards collected may be stapled along the edge of the opening
page, if desired. They should not be paper-clipped or left loose in the
note book.
Since the field notebook represents the single most important reference
for the inspection report, and for any subsequent legal support that may
arise out of an enforcement action, great care is to be taken with detail,
legibility, thoroughness and accuracy. All entries are to be dated, if
appropriate and all statements identified as to speaker and title. All
records reviewed at a facility should be identified by title, content and
period covered. The field notebook is to contain only facts and
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IX-2
observations, and not contain any personal opinions or prejudgment as
to whether or not a violation has occurred.
An attempt should be made by the inspector to exclude potential CBI
information in the notebook, so as to avoid having it declared CBI at the
exit conference. If necessary, it may be easier to declare the entire
bound notebook as TSCA CBI, rather than trying to declare a single page
or entry.
The field notebook is considered Agency property and, as such, is to be
retained in the NEIC evidentiary files, along with the final reports and
other inspection related documents.
C. RECORDS
Copies of records, data and correspondence will likely be the most
common form of evidence collected during an inspection, and will usually
be the most substantive source of documentation for most TSCA § 5/8
violations. Production summary, batch, sales, inventory, research and
shipping records will provide documentation for most TSCA § 5/8
potential violations. Generally, collected documents will be either
photocopies or hardcopy printouts from automated data systems.
In most cases, copies of documents are to be taken for the following
reasons:
To document potential violations
To allow further review when more time is available after return to
the office
To allow review by OTS or other headquarters personnel
As a result of headquarters guidance, [i.e., TSCA § 8(c)/8(e)
policies]
For future reference purposes [i.e., 8(c) records for subsequent
record retention purposes during future inspections at a facility]
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IX-3
As examples of forms, policies or records represent good
procedures and/or compliance
The collection of the latter most type of records as well as copies of any
records that don't represent noncompliance should be kept to a
minimum, particularly in light of the probable CBI nature of such record
copies. Every effort should be made by the inspector to have all
necessary records ready at the facility site for review and to fully examine
these records at the site during the inspection; any followup requested
information will necessarily generate additional records, much of which
may not prove useful for evidentiary purposes.
Detailed procedures for collecting records are given in Chapter 4 of the
TSCA Inspection Manual,' and will not be elaborated upon here, except
to emphasize the requirement for identifying such record copies. This
may be accomplished either by using the Branch document stamp
[Figure IX-1] on the back of the first page of a related set of documents
and stapling them together. Otherwise the back or lower right hand
corner should be initialed and dated for each sheet.
Figure IX-1
DOCUMENT STAMP
Inspection
Doc. No		
No. Pagea	
Date	By
Before the TSCA Receipt for Samples and Documents is issued, the
inspector should assure that all requested documents have been
received and that all copies are fully legible with respect to necessary
information.
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IX-4
The inspector should make a special effort while at the inspection site to
avoid having followup information submitted subsequent to the onsite
visit. Followup copies will be difficult to compare against originals. In
addition, it will delay preparation of the inspection report and may place
an extra burden on the DCO office.
If followup documents are necessary, the inspector should make
explicitly clear to the facility management what document copies are
needed and a deadline for their submittal is to be established. The
inspector should request that the document copies be accompanied by a
signed letter or statement listing the documents submitted and identifying
which documents are claimed TSCA CBI. The facility official should also
initial and date each document to verify its authenticity. A letter of
acknowledgement should be sent for any followup documents received.
D. PHOTOGRAPHS
Experience has proven that photographs rarely will be necessary as
documentation for a TSCA § 5/8 potential violation; however,
occasionally a photograph may prove to be the most expeditious means
of documenting labels on large drums or other containers, processes
manufacturing, safety problems or environmental releases. For this
reason the inspector should always take an instant film camera, even if it
is left in the car. The instant film type camera will allow for immediate
review, as well as providing a cpavefiierit tttians of handling the photo-
graph^) as CBI, if necessarv. f; c
A facility policy regarding photography or possession of cameras on the
premises should be established during the opening conference, or via
telephone so that there are no misunderstandings when photographs are
needed. When reluctancy is encountered, several approaches that have
been used in the past are having a company official actually take the
instant photo, allowing side by side photos taken by a company official or
providing duplicates.
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PHYSICAL SAMPLES
(To be completed)
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X-1
X RECORDKEEPING AND DATABASES
A. RECORDKEEPING
The TSCA § 14 Confidential Business Information (CBI) requirements
largely dictate the maintenance procedures for the TSCA § 5/8 inspec-
tion records. Specific requirements for handling TSCA CBI materials are
defined in the TSCA Security Manual4 and all TSCA § 5/8 program pro-
cedures will adhere to the requirements spelled out therein. Each
inspector will have the responsibility to assure that all CBI procedures
are properly followed.
Records exist in both hard-copy and database (generally floppy disc)
forms and fall into several categories:
Documents or printouts received from the OTS Information
Management Division (IMD) that are required for targeting and/or
specific inspection purposes - hard copy or microfiche (mostly
CBI).
Exhibits, notebooks and other documents that are brought back
from inspections (both CBI and non-CBI)
Final inspection reports and summaries (usually CBI)
NEIC generated databases, (both CBI and non-CBI)
Other miscellaneous files, records and references (non-CBI)
These records are further identified as follows and are to be maintained
and accessed as described:
1. Documents Derived from IMD
a. 6 5 Submitter Summary: Computer printout by EPA region
listing PMNs, TMEs, LVEs, PEs and bona fides - issued
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X-2
quarterly - CBI - maintained by DCO, available upon
request, primarily used for targeting; most essential infor-
mation summarized by company site on TSCA DOC and/or
TSCA ORDER databases (see Section X-A.3).
b.	6 5 Withdrawal Submitter Summary: Computer printouts
by EPA region listing withdrawn PMNs, TMEs, LVEs and
PEs - issued quarterly - CBI - maintained by DCO, available
upon request, primarily used for targeting; most essential
information summarized by company site on TSCA DOC
and/or TSCA ORDER databases.
c.	6 8(a1 Level A Submitter Summary: Computer printout by
EPA region listing Chemical Abstracts Service (CAS)
Registry number by facility site - updated quarterly - CBI -
maintained by DCO, available upon request; primarily used
for targeting; most essential information summarized by
company production site on TSCA DOC and/or TSCA
ORDER.
d.	PMN. TME. LVE. PE. bona fide and PAIR Reports: Hard
copies (or microfiches) - sent by IMD, as requested - CBI -
maintained by DCO, available upon request, primarily used
for specific inspection purposes [§ 8(d) and/or § 8(e)
information will be handled in similar fashion].
e.	TSCA Status Report: Hard copy computer printout that
summarizes PMN, TME, LVE and PE submitters by
submittal date, 90-day review date, notice manager, and
review status - non-CBI - maintained in open Branch files -
updated quarterly - available upon request; used for
specific PMN and other § 5 review purposes for specific
inspections. NOC dates will be added in the future.
f.	Notice of Commencement (NOC) Summary: Hard copy
printout that lists those PMNs for which NOCs have been
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X-3
submitted - updated quarterly - non-CBI - each inspector
should have copy; used for specific PMN inspection
purposes. This listing has been found to be incomplete;
however, in that not all NOC submittals have been included
on this list.
g. Chemicals on Regulatory Rules Summary (CORRS) Listinn:
Summary of all chemicals on § 4, § 8{a) Level A, § 8(d),
SARA and SNUR rules - non-CBI - each inspector should
have copy; used primarily for completion of § 8(a) Level A
and§ 8(d) phase of each inspection.
2. Exhibits. Notebooks and Other Specific Inspection Documents
a.	Exhibits: Documents collected at an inspected facility to
document potential violations or as required by § 5 or § 8
inspection guidelines [Appendices E to J] - usually CBI.
Each inspector will arrange with a program DCO to log in all
TSCA CBI materials within 5 days of returning from an
inspection. These materials can then be logged back out to
the inspector for up to 90 days for report preparation
purposes. Storage during this period will be in one of the
working CBI file cabinets or the inspector's controlled
briefcase. Pertinent exhibits will be permanently main-
tained with the inspection report; unused exhibits will
normally be shredded upon notification of "Case Closed" by
OCM.
b.	Inspection Field Notebooks: Records of field notes, results
of interviews and other data or observations taken as part of
an inspection • usually non-CBI (otherwise treated as
described in Part 2 a. above). The inspector will assure
security and retention of all field notebooks during and after
the report preparation period. Upon completion of the final
inspection reports, the field notebook(s) will be filed in the
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X-4
CBI document file containing NEIC copies of the final
reports.
c. Final Reports: Will normally be either a full narrative report
or the short worksheet form with a summary, usually CBI.
All pertinent exhibits will be attached to either format. All
reports will be reviewed by designated staff, copied,
entered into the tracking log and formally filed (and
transferred to OCM, if appropriate). All CBI reports (either
format) will need to be logged in by the DCO. The tracking
log will also be updated to reflect completion of the report.
3. NEIC Generated Databases
a.	TSCA DOC (CBI): Computer (PC) based system designed
to track and catalogue documents received from OTS by the
P&TS Branch for inspection purposes - updated as
documents are received - printouts available by facility,
geographical area or in entirety by DCO or senior program
staff.
b.	CHEMCOMP (non-CBI): Computer (PC) based system
designed to catalogue inspected and non-inspected
facilities in Categories 1 and 2 of the NAIS (see Chapter III)
- updated quarterly or as necessary - printouts available by
geographical area or in entirety from DCO or senior staff.
c.	TSCA Order (CBh: Computer (PC) based system designed
to track documents ordered from OTS by the P&TS Branch -
updated quarterly or as OTS documents are ordered and
received - printouts available by facility, potential
geographical area (exact production site for a requested
document may not be specifically known until the document
is received and reviewed) or in entirety from DCO or senior
staff.
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X-5
d.	Tracking Log fnon-CBI): Hard copy log to monitor
completed inspections with respect to inspector(s)
identification, inspection number, facility, key dates,
inspection phases, report status and case status
maintained by senior program staff and available for review
upon request. [Will eventually be consolidated with OCM
"FIFRA and TSCA Tracking System" (FTTS).J
e.	Tracking Sheets (non-CBH: Individual documentation sheet
completed by inspector (except tor assignment of inspection
number) that provides basic information about a
prospective TSCA § 5/8 inspection - filed by senior program
staff.
4.	Telephone and Conversation Loos
Employees must keep telephone logs (Form 7740-12) and
conversation logs (Form 50271-10) of all telephone calls and
conferences with individuals located outside their facilities during
which TSCA CBI is discussed. Both forms must be logged into the
CBI Document Tracking System.
5.	Other NEIC Files and Records
Correspondence Files - hard copies of all correspondence
pertaining to inspections (notification and followup letters),
program operation and routine requests for information - (mostly
non-CBI) - copies will be maintained both in Laboratory Services
Reading File and with author; supervisor will also retain copies of
all program related letters, memoranda and reports.
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X-6
B. ORGANIZATION OF TSCA CBI FILES'
All documents sent from EPA Headquarters, collected at an inspection,
sent from a company, or originated by an NEIC employee containing
information classified as TSCA CBI must be controlled by the document
tracking system. This system will enable the Document Control Officer
(DCO) to track a document's movement from the time it is written or
received until the time it is destroyed or transferred.
The document control system at NEIC is manually controlled and
operates much like a lending library. An employee may check out
documents for up to 90 days. While using TSCA CBI, the employee is
responsible for ensuring that no unauthorized disclosure of that
information occurs. The employee must either maintain constant control
of the TSCA CBI in his/her possession, store the materials in a TSCA
approved storage container or return the materials to a DCO. The
employee may not mail, copy, declassify or send through interoffice mail
a TSCA CBI.
The types of documents that are tracked in the NEIC document tracking
system are as follows:
1.	Headquarters Documents
Headquarters TSCA CBI documents have been previously logged
into the IMD automated tracking system. They are sent on
permanent loan to the NEIC-DCO from the HQ-DCO.
2.	Inspection Documents
These are documents collected on an inspection that the company
has declared as TSCA CBI. The inspector must hand carry these
documents back from the inspection and, upon return to the office,
immediately turn them over to the DCO for logging into the tracking
Prepared by Kaye Mathews. Pesticides and Toxics Substances Branch, NEIC
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X-7
system. The inspector may then check these documents out for up
to 90 days.
3.	Personal Working Papers
There is a limited exception from logging in procedures for
personal working papers containing TSCA CBI which remain in
the possession and control of the author. These types of
documents include notes, outlines and drafts of reports or letters.
They must be stored and handled like any other TSCA CBI
document. These materials may only be transferred for typing and
then should have a green cover sheet on the front marked "Draft."
If the materials leave the originator's possession and control for
any other reason, the material must be assigned a document
control number. CBI draft documents should be shredded if the
author has no further use for them.
4.	Computer Generated TSCA CBI
These are normally floppy discs for use with personal computers
that may contain targeting information, inspection data, inspection
reports and other CBI information associated with the TSCA § 5/8
program. These discs are green, as required by the TSCA CBI
manual, and are treated as documents for logging purposes.
C. INFORMATION SOURCES
The following information sources will be available to the TSCA
inspectional staff for targeting specific inspection or for general
information purposes.
1. Chemicals in Commerce Information Summary fCICIS): This
database, available by facility, reflects the original submission to
the TSCA § 8(a) Inventory in 1978. CBI information is not
provided. A printout for a facility can be obtained from Information
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X-8
Services or P&TS senior staff. An example of a typical CICIS
printout is given in Figure X-1.
2. Dun & Bradstraet (D&B) Report: This database, available either by
facility (short form) or by corporation (long form) provides financial
details, as well as other general information as to size, names of
corporate officers and a brief description of operations. The
current credit status of a facility is also given. The D&B reports are
available from Information Services. An example of a typical D&B
short form is given in Figure X-2.
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Figure X-1
CICIS PRINTOUT EXAMPLE
10/09/37	TSM INVENTORY REPORT FOR MID 00=4370	F0IMD
W)£437D MININGS CH£fl!CflL COMPANY
1650 CANTON HIGHWAY
MARIETTA. Eft 30066
REGION: 4 COUNTY: COPS
7 RECORDS FOUND.
10/U9/87 TSCfl INVENTORY REPORT FOR PJID 00£437D	F0I«1iD
64-O.M 9Ci (MANUFACTURE)	CNT:
1977 PRODUCTION OF u TO 1.000 LBS.
Glycine. N.NM.c-ethanediyltns^CN-fcarboxviiethyJI-. tetrasodiuni salt
l£8-y4-l SCI (MANUFACTURE)	CNT:
1977 PRODUCTION OF 100,000 TO 1 MILLICN LBS.
Carbanoditfuoic acid, dimethyl", sodium salt
1^-59-6 9CI (MANUFACTURE)	CNT:
1977 PRODUCTION OF luO.OOO TO 1 MILLION LBS.
Carbaaiodithioic acid. 1. J-ethanedivltus-. disodiuia salt
533-74-4 BCI SCI IttANUFACTURf)	CNT:
1977 PRODUCT ION OF 100,000 70 1 MILLION LBS.
2H-1,3.5-Thiadi.
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X-10
Figure X-2
D&B SHORT FORM
*IN DATE*
DUNS: 08-212-4637
D F A OF CALIFORNIA (INC)
BOX 86
FRESNO CA 93707
1855 S VAN NESS
FRESNO CA 9 3721
TEL: 209 233-7249
DATE PRINTED
NOV 06 1987
AGRICULTURAL
LABORATORY
SIC NO.
73 99
RATING BRANCH
EMPLOYS 10
BRANCH MANAGER: H RIEDLE
PAYMENTS (Amounts may be	rounded	to nearest	figure	in prescribed ranges)
REPORTED PAYING	HIGH	NOW	PAST	SELLING LAST SA1
RECORD	CREDIT	OWES	DUE	TERMS WITHIN
10/87 (001)	2500	2500	1 Mo
06/87 Ppt-Slow 15	2500	2500	1000 N30	1 Mo
10/86 DISC	50	-0-	-0-	2-3 Mos
This is a branch: headquarters are located at 303 Brokaw Road,
Santa Clara, CA. Headquarters D-U-N-S 07-631-5126. The manager has
authority to make purchases of supplies. Bills are paid generally
from headquarters. This branch operates as the Fresno district offic
and laboratory for dried fruit and tree nuts.
FACILITIES: Rents 6,000 sq. ft. in one story brick building in
normal condition. Premises neat.
LOCATION: Industrial section on well traveled street.
11-06(9A0 /15 8)	052 160
FULL DISPLAY COMPLETE
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XI-1
XI. TRAINING
A training plan is established for all new inspectors who will participate in
the TSCA § 5/8 inspection program. This training plan will be somewhat
flexible, depending on the experience, versatility and other traits of the
incumbent inspector. This plan assumes that the inspector will be entry level
(GS-5/7) with minimal specific experience in the inspectional/investigational
area, but having a BS degree with a major in one of the science or engineering
fields. The training is divided into: (1) on-the-job; (2) self-study and
(3) participation in seminars, workshops and courses.
The following describes a minimal training plan for the new inspector
during the development of his or her career to the senior specialist level,
including benchmarks of achievement. These are intended as guidelines only
and there will likely be justifiable deviations from this course of development.
A. GS 5/7 ENTRY LEVEL
1.	Participate in routine TSCA §5/8 inspections as assistant to
experienced inspector (at least one inspection trip per quarter
while in training).
2.	Assist experienced inspector in review of TSCA § 5/8 data.
3.	Assist experienced personnel in the inspection targeting process.
4.	Independently study the TSCA Act, TSCA regulations (40 CFR
Part 700 to End), the NEIC TSCA § 5/8 SOPs, Federal Register
notices, as identified by senior staff, the TSCA Inspection Manual,
EPA Headquarters directives and other reading material as
assigned.
5.	Familiarize himself/herself with NEIC, Headquarters and public
databases that contain chemical and facility information.
6.	Attend and participate in staff meetings.
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XI-2
7.	Attend and participate in seminars, briefings and discussion
groups related to TSCA inspection program.
8.	Participate in mock inspection conducted by expenenced program
and legal personnel.
At the end of this entry level training program, the new inspector should
be capable of independently conducting a routine TSCA § 5/8 inspection
and capably assisting in nonroutine or priority inspections.
B. GS 9/11 JOURNEYMAN LEVEL
1.	Lead or conduct a number (at least 15) of routine TSCA § 5/8
inspections.
2.	Provide guidance and training to entry level (GS-5/7) inspectors
3.	Assist with the conduct of complex, priority, comprehensive or
otherwise nonroutine inspections.
4.	Continue review of the TSCA statute, associated regulations,
Federal Register notices and guidance documents. Continue
review of Chemical Regulation Reporter and other newsletters/
journals, as appropriate.
5.	Participate in assignments to EPA Headquarters and/or Region II,
III or V office for exchange of information.
6.	Routinely utilize facility and chemical databases and other infor-
mation sources.
7.	Continue to participate in staff meetings, seminars, briefings and
workshops.
At the end of the journeyman level training, the inspector shall be able to
conduct or direct a comprehensive, high-priority or other inspections of
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XI-3
more complex nature and be able to provide meaningful direction to
junior level personnel.
C. GS-12 SENIOR SPECIALIST
Training will include, but not be limited to the following:
1.	Lead or conduct at least 10 nonroutine or comprehensive
inspections.
2.	Provide leadership to other inspectors in terms of data review, new
techniques, new policies, legal requirements and so forth.
3.	Assist the supervisor with program planning, SOP development,
targeting and training.
4.	Serve leading roles in local and national meetings, workshops
and seminars.
5.	Prepare briefing documents for staff and others regarding
significant and/or new TSCA § 5/8 related issues.
At the end of this level training, the senior specialist will be expected to
provide advanced leadership to the TSCA § 5/8 program at both NEIC
and at the national levels. He or she will be considered an expert in the
field.
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REFERENCES
1.	"U.S. EPA Toxic Substances Control Act (TSCA) Inspection Manual," U.S
Environmental Protection Agency, Washington, D.C., 1982 [Part 1 also
published by the Government Institute, Rockville, MD (1985)]
2.	"NEIC Policies and Procedures Manual," U.S. EPA National Enforcement
Investigations Center, Denver, CO (latest edition)
3.	"U.S EPA Toxic Substances Control Act Chemical Substances
Inventory," Volumes l-IV, U.S. EPA, Washington, D.C. (latest edition)
4.	"TSCA Confidential Business Information Security Manual," U.S. EPA,
Office of Toxic Substances, Washington, D.C. (latest edition)
5.	"U.S. EPA FIFRA Inspection Manual," U.S. EPA Office of Compliance
Monitoring, Washington, D.C.
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APPENDICES
A.	§ 5 ENFORCEMENT RESPONSE POLICY
B.	§ 8 § 12 and § 13 ENFORCEMENT RESPONSE POLICY
C.	PMN FORM
D.	GLOVE TESTING GUIDELINES
E.	EPA HQ § 5 INSPECTION GUIDELINES
F.	EPA HQ § 8{a) LEVEL A GUIDELINES
G.	EPA HQ § 8(b) GUIDELINES
H.	EPA HQ § 8(c) GUIDELINES
I.	EPA HQ § 8(d) GUIDELINES
J.	EPA HQ § 8(e) GUIDELINES
K.	§ 8(e) INTERPRETIVE STATEMENT
L.	NEIC REPORT WORKSHEET
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APPENDIX A
§ 5 ENFORCEMENT RESPONSE POLICY
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AIJR 5
TSCA SECTION 5
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIOES AND TOXIC SUBSTANCES
THE U. S. ENVIRONMENTAL PROTECTION AGENCY
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TABLE OF CONTENTS
INTRODUCTION
Summary of Rul es/Requ 1 r ement s	 1
DETERMINING THE LEVEL OF ACTION
Administrative Civil Penalty		2
I n junctl ve Action				3
Crimi nal Sanctions		4
assessing A CIVIL Administrative penalty
Summary of the Penalty Policy	 5
Background		5
Appl 1 ca blU ty. . 					6
Calculation of the Gravity Based Penalty		6
Nature		7
Circumstances		8
Extent		13
Gravity		15
Per-Day Assessments		15
One-Day Violations		15
Immfnent Hazard		16
Gravity Based Penalty		16
Adjusting the Gravity Based Penalty		17
Voluntary Disclosure		17
History of Prior Violation		19
Culpability					19
Explanation of the Penalty Policy	 20
Nature.........						20
Circumstances		21
Extent		22
Gravity of the Violation		25
Adjustment Factors		27
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INTRODUCTION
Section 5(a)(1) of the Taxic Substances Control Act (TSCA}
requires chemical manufacturers and importers to notify EPA
90 days prior to manufacturing or importing a new chemical
substance in the United States. EPA will evaluate the new
chemical substance within 90 days based on the information
supplied by the submitter. If the Agency finds that the Infor-
mation supplied 1s Insufficient to permit a reasoned evaluation
of the health or environmental effects of the chemical substance
and that in the absence of such information the manufacture,
distribution, use or disposal of the chemical substance may
pose an unreasonable risk of injury to fiealth or the environ-
ment, or that the chemical substance may be produced 1n sub-
stantial amounts which may result in significant human or
environmental exposure, the Agency may issue an order under
TSCA §5(e) to prohibit or limit the manufacture, dlstrlbution,
use or disposal of the chemical substance. TSCA 55(a)(2)
allows the Agency to identify uses of a chemical substance
which EPA has determined are significant new uses and to require
notification of those significant new uses. Certain exemptions
from the full reporting and notification requirements are allowed
under TSCA §5(h). These exemptions may be found at 40 CFR 720.30
through 720.38 and at 40 CFR Part 723. The major exemptions
from notification are research and development, test marketing,
small quantities (less than 1,000 kg per year), certain polymers
and substances used in instant photographic and peel-apart film
articles.
Failure to comply with the provisions of TSCA §5 is a
violation of TSCA §15 and subject to the remedies found in
TSCA §15.
Summary of TSCA S5 Requirement's 	
Premanufactur1nqNot1f1cat1on (P MN) - Under TSCA §5(a)(l) and
40 CFR 720, manufacturers and importers of new chemical
substances are required to submit, 90 days prior to manufac-
turing or Importing, a notice of their intention to conduct
such activities as well as any test data in their posession
or control In accordance with 40 CFR Part 720.50.
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Slgniffcant Hew Use R"|es ( S N U R) - Under TSCA 55(a)(2) and
40 CFR 721, EPA specifies by rule the use(s) of chemical
substances which 1t considers to be significant new uses.
EPA must be notified prior to commencement of any significant
new use.
Notice of Commencement(NOC) - Under 40 CF3 720.102, EPA re-
quires that any person who commences the manufacture or Im-
portation of a new chemical substance for which that person
had previously submitted a PMN, must submit a notice of
commencement of manufacture or import on or no later than
30 days after the first day of manufacture or Import.
TSCA § 5(e ? Order - Under TSCA §5(e), If EPA determines that
the information available in support of a PMN 1s Insufficient
to make a reasoned evaluation of the health or environmental
effects of a chemical substance, EPA will issue an order
imposing controls, restrictions or prohibitions on the manu-
facture of the substance in order to address the concerns
of EPA.
TSCA 55(f) Order - Under TSCA 55(f), 1f finds that the man
ufacture, import, processing, distribution, use or disposal of
a chemical substance presents or will present an unreasonaDle
risk of injury to health or the environment before a rule
promulgated under TSCA §6 can protect against such risk, the
Administrator may issue an immediately effective proposed
rule to impose controls or restrictions to protect against
such risk or may issue an Order to prohibit manufacture,
processing, or distribution In commerce.
TSCA §5(h) Exemptions - TSCA 55(h) and 40 CFR 720.30 through
720.38 and 40 CFR 723 exempt certain substances and classes
of substances from the full notification and reporting require
ments of TSCA 55.
DETERMINING THE LEVEL OF ACTION
Enforcement alternatives Include civil penalties, Injunctive
relief, crlafnal action or some combination of these actions.
Notices of noncompliance are not appropriate for TSCA $5
violations.
Administrative Civil Penalty
An administrative civil penalty will be the appropriate
response for most violations of these regulations.
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Conc urrence
CfvU penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring (0CM) of the Office of
Pesticides and Toxic Substances prior to initiating a civil
ad mlnistrative penalty for TSCA §5 violations. Reductions for
settlement purposes require the concurrence of OCM as well and
must be 1n accordance with the TSCA Penalty Policy and this
Enforcement Response Policy.
Each reduction must be based on the TSCA Penalty Policy
or this policy and justified in the Consent Agreement and
Ffnaf Order with specific dollar amounts attributed to each
reduction. Headquarters may relax concurrence requirements
on a Region by Region basis after the Regions have gained
experience with actions under these rules and this policy.
Injunctive Action	
In most circumstances, a TSCA S16 administrative action
will provide a complete aid timely remedy for TSCA 45 viola-
tions. However, certain cases may present the need for the
types of i njuncti ve relief available jnder TSCA 517 in addi-
tion to TSCA §16 administrative actions.
Section 17 provides the U.S. District Courts with the juris-
diction to:
-	Restrain persons from taking actions prohibited by TSCA §§
5, 6 , and 15.
-	Compel persons to take actions required by TSCA.
» Direct manufacturers, importers, or processors in violation
of TSCA to: provide notice of the violation or risk of in-
jury to, or repurchase the product from, the consumers of
the violative product.
-	Seize any chemical substance manufactured, Imported, pro-
cessed, or distributed in commerce in violation of TSCA.
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It is important to note that TSCA 517 does not require
an imminent hazard or recalcitrant respondent as a condition
to its use. However, the Agency believes that the use of
TSCA §17 should be limited to those instances where a civil
penalty action will not mitigate a hazardous situation, is
not likely to result in timely compliance, or where penalties
alone do not provide a complete remedy. Injunctive action is
appropriate m the following examples:
*	illegal production/use which presents a hazar^ to human
health or the environment;
*	violations of TSCA §5{e) or	5(f) orders, Low Volume Ex-
emptions, or Test Marketing	Exemptions which Involve
the failure to use personal	protective equipment or
chemical control measures;
*	contumacy, undue delay, or refusal of a violator to
comply with TSCA requirements and regulations; or
*	repeat offenders for whom the penalty adjustments for past
history of violations is unlikely to deter future violations.
CriminalSanctions
Criminal sanctions pursuant to TSCA 516(b) are the most
serious sanctions available for violations of TSCA §5.
Accordingly, criminal sanctions may be sought in situations
that, when measured by the nature of the conduct, the compli-
ance history of the subject(s) and the gravity of the conse-
quences to human health or the environment, reflect the most
serious cases of misconduct.
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5
ASSESSING A CIVtL ADM INI STRATIV£ PENALTY
Summary of the Penalty Polic7
Background	
The TSCA Civil Penalty Policy, published in the Federa1
Reg 1ster on September 10« 1930, «statj^1shes a system for deter-
mining penalties in admi ni s tra t f ve actions brought pursuant to
TSCA 516. Under that system, penalties are determined in two
stages: (1) determination of a "grav1ty'based penalty* (GBP),
and (2) adjustments to the gravity based penalty.
To determine the gravity based penalty, the following factors
affecting a violation's gravity are considered:
* The "nature" of ttie violation.
The "circumstances" of the violation.
* The "extent" or potential for harm "that could result
from a given violation.
These factors are incorporated into a matrix which ailows
determination of the appropriate gravity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made in con-
sideration of these other factors:
c ulpabi1i ty,
history of such violations,
ab1 H ty to pay,
ability to continue i* business, and
such other natters as justice may require.
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The TSCA Civil Penalty Policy system provides a framework
for the development of individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the Gravity Based Penalty Matrix to
assess penalties for specific violations of TSCA §5 and regula-
tions promulgated pursuant to this section.
Applicability	
This polfcy fs fmnedfatefy applicable and sttoufd i>e
used to calculate penalties for all administrative actions
concerning TSCA §5 instituted after the date of this policy,
regardless of the date of violation. Pending cases should
be reviewed to determine whether the penalty calculated under
this policy is lower than the penalty in the civil complaint.
If this policy yields a lower penalty, an amendment to the
complaint should be made to substitute the lower penalty.
This policy should not be used to raise penalties 1n
existing actions. No case should be settled for an amount
higher than the penalty which this policy would yield.
Calculation of the Gravity Based Penalty	
Penalties for TSCA S5 violations vary depending on the
nature, extent, circumstances and whether penalties ire to be
calculated as one-day assessments or per-day assessments. In
establishing oach of these, the Agency considered the following
factors in a comparative manner:
*	Potential for and/or the relative degree of harm to
human health or the environment caused by failure to
comply. Tftfs directly relates to tfte rropact on the
Agency's mandate to evaluate and control the poten-
tial for human health or environmental effects of a
new chemical substances prior to its production or
import.
" Potential exposure of the public or the environment
to an unregulated new chemical substance.
*	Impact on the validity of the Inventory, which the
statute mandates the Admin1strator to keep current.
*	Deterrent effect the penalty would have or the like-
lihood that the penalty will deter future violations.
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Hature				
The nature of the TSCA violation depends on whether the
violation relates to chemical control, contro 1-associated data-
gathering, or hazard assessment. It is important to make this
determination first. Determining the nature of the violation
is necessary prior to using the extent matrix. The following
list places the violation types in their respective categories.
1)	Chemical Control Violations
*	Noncompliance with TSCA 55(e) or 5(f) orders,
rules, or injunctions and significant new use rules
(those aspects dealing with the actual control of
the substance, i.e., production, commercial use,
disposal, production restr1ct1ons , etc.}.
*	Noncompliance with research and development exemption
restrictions (noncompliance with the adequate warning
and supervision of a technically qualified Individual
requlrement).
*	Noncompliance with test marketing exemption
restrictions (those aspects dealjng with the
actual control of the substance).
*	Noncompliance with exemption restrictions under
40 CFR 723 (those aspects dealing with the actual
control of the substance).
2)	Control-Associated Data-Gathering Violations
*	Noncompliance with the recordkeeping provisions of
TSCA §5 orders, rules, or injunctions.
*	Noncompliance with the recorakeepfng provisions of
exemption restrictions under 40 CFR 723.
*	Noncompliance with the recordkeeping provisions of
the research and development and test marketing
exemption restrictions.
3)	Hazard Assessment Violations
*	All failures to notify EPA when such notification
1 s requl red by 1 aw.
*	Withholding material Information from or submitting
false or misleading Information in a TSCA §5 notice
or exemption request.
*	Commercial use of a substance produced without a
PMN or valid exemption.
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Nortcompl iance with the reporting provisions of
TSCA $5(e) or 5(f) orders, rules, or injunctions.
* Any violation not listed previously.
Ci rcumstances		
Once the nature of the violation has been determined, the
second step in calculating the penalty is determining the cir-
cumstances of the violation. The circumstances determination
is based upon the probability that harm could have taken
place - an a priori potential for harm to the environment or
the Agency's decisionmaking or ability to regulate, I.e.,
potential exposure to an unregulated chemical substance or
harm to the integrity of the Inventory.- Any after the fact
determination that harm did or did not take place is irrele-
vant to the initial circumstance level determination. The
gravity based penalty matrix provides for six circumstance
levels. Levels one and two represent the Agency's determina-
tion of circumstances where there exists a high probability
of harm. Levels five and six represent circumstances of low
probability of harm and levels three and four fall between
these high and low probabilities.
The circumstance level of a violation 'is designated in
the following manner. Please note that many of the levels
refer to a PMN being subject to a TSCA 55(e) or 5(f) action.
Please refer to page 22 for a further explanation of when a
substance is subject to a TSCA §5(e) or 5(f) action.
Failure to Notify
Failure to submit a PMN not subject to a TSCA §5(e) or 5(f)
order or exemption when the substance was not distributed
to others j>r further processed for commercial use by the
company is a level 4 violation, per-day.
Failure to submit a PMN not subject to a TSCA S5(e) or 5(f)
order or exemption when the substance was distributed to
others or further processed for commercial use by the com-
pany Is a level 3 violation, per-day.
Failure to subalt a PMN when the substance is or would have
been the subject of a TSCA §5 (e) or 5(f) action but was not
either distributed to others or further processed for
commercial use by the company"Ts a level 2 violation, per-day.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action and the
substance was either distributed to others or further
processed by the company is a level 1 violation, per-day.
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Failure to submit a PMN for a chemical substance which would
meet all requirements for a polymer exemption under 40 CFR
723.250, except that the company did not file for an exemption,
will be assessed as a level 5 violation, per-day.
Failure to submit a PMN for a chemical substance which would
meet all requirements for a polymer exemption under 40 CFR
723.250, except that the company did not file for an exemption
and the substance was further processed for commercial use,
distributed to consumers, or released uncontrolled into the
environment will be assessed as a level 4 violation, per-day.
Failure to submit a Notice of Commencement is a level 3
violation, one-day.
Failure to submit a timely Notice of Commencement (early or
late submission, up to 30 days prior to manufacture or 30 to
60 days after manufacture) is a level 6 violation, one-day.
Failure to submit a timely Notice of Commencement (early or
late submission, more than 30 days prior to manufacture or
more than 60 days after manufacture) 1s a level 4 violation,
one-day.
Withholding information or submitting false or misleading
information with regard to a PMN, Notice of Commencement,
Significant New Use Notice, or exemption request Is a level
1 violation, per-day.
Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or
Injunctions and Significant New Use Rules
Violation of on-site restrictions 1s a level 2 violation,
pe r-day.
Violation of off-site restrictions where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment 1s a level 1
"violation, per-day.
Failure to subalt a Significant New Use Notice when the sub-
stance was not distributed 1s a level 2 violation, per-day.
Failure to	submit a Significant New Use Notice when the sub-
stance was	distributed to consumers is a level 1 violation,
pe r-day.
Violation of production ban or restriction is a level 1
violation,	per-day.
Failure to	generate reports as required is a level 2 violation,
per-day.
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Failure to generate reports as required, where the substance
was either processed by another firm o_r distributed to
consumers or released uncontrolled into the environment is
a level 1 TTolation, per-day.
Late submission of required reports where the substance was
not distributed or processed is a level 4 violation, per-day.
Late submission of required reports where the substance was
either processed by another firm ojr distributed to consumers
or released uncontrolled into the environment is a level 3
"violation, per-day.
Withholding Information or submitting false or misleading
Information Is a level 1 violation, per-day.
Violation of the recordkeeping provisions where the firm
produces the missing records within 5 days of a written EPA
request is a level 4 violation, one-day.
Violation of the recordkeeping provisions where the ffrtn
cannot produce the missing records within 5 days of an EPA
request 1s a level 3 violation, one-day except as specified
on page 26 of the policy.
Commercial Use of a Substance Produced Without a PMN or Valid
Exempt 1 on"
Commercial use violations will be charged in two circumstances:
1.	Where a company processes or uses a chemical substance which
it did not manufacture and it has reason to know 1s not on
the Inventory.
2.	Where a chemical substance was manufactured or imported ille
gaily on just a few occasions and processed over a long per-
iod of time, the substance would have been subject to a TSCA
S5(e) or 5(f) order, and the activity could have caused
substantial endangerment to health or the environment.
Commercial itii violations will be assessed as follows:
Violation where the substance was not processed by or dis-
tributed to others after receipt by the user 1s a level 4
violation, per-day.
Violation where the substance was further processed by or
distributed to others 1s a level 3 violation, per-day.
Violation where the substance is or would have been the subject
of a TSCA S5
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Yiolation where the substance is or would have been the subject
of a TSCA 55(e) or 5(f) action and was either processed by
others 0£ released uncontrolled into the environment is a
level 1 violation, per-day.
In cases involving imminent hazard the Agency reserves the right
to charge a manufacturer with both failure to submit a PMN and
illegal commercial use of the substance.
Noncompliance with Test Marketing Exemption Restrictions
Overproduction by 10* or less is a level 3 violation, per-day.
Overproduction of more than 10X would be charged as a failure
to submi t a PMN.
Violation of exposure related, on-site restrictions Is a
level 2 violation, per-day.
Violation of recordkeeping provisions is a level 4 violation,
one-day except as specified on page 26 of the policy.
Violations of the off-site control provisions of a TME where
the substance was either distributed to consumers or was
released uncontrolled into the environment 1s a level 1
violation, per-day.
Noncompliance with Research and Development Exemption Restrictions
Violations regarding the labeling of the R&D substance where
the substance was further processed by another firm is a
level 2 violation, per-day.
Violations regarding the labeling of tne R&D substance where
the substance was either distributed to consumers 0£ was
released uncontrolled Into the environment is a level 1
violation, per-day.
Please note that any violation of an R&D exemption other
than failure to adequately label the R&D substance, would
cause the charge to be a failure to submit a PMN.
Noncompliance with Low Volume Exemption Restrictions
Violations regarding the notification of customers of the re-
strictions on use of the substance is a level 2 violation,
pe r-day.
Violations regarding the failure to notify EPA of any changes
in site or use of the exempted chemical 1s a level 2 viola-
tion, per-day.
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VioUtions of the recordkeeping provisions of the low volume
exemption is a level 3 violation, one-day except as specified
on page 26 of the policy.
Violations of the 1,000 kg. production limit would be viewed
as a failure to submit a PMN.
Violations regarding the failure to maintain required exposure
controls is a level 2 violation, per-day.
noncompliance with the Instant Photographic and Peel-Apart
Film Article Exemption Restrictions
Failure to limit manufacturing and processing to site{s)
listed 1n the exemption application 1s a level 5 violation,
per-day.
Distribution in commerce or use of a peel-apart film article
containing a new chemical substance prior to its being cleared
through the PMN process would be considered a failure to
submit a PMN and subject to the penalties thereunder.
Failure to follow the conditions of manufacture for Instant
photographic or peel-apart film artfcles where the substance
would not have been subject to a TSCA S5(eT or 5(f) order is
a level 2 violation, per-day.
Failure to follow the conditions of manufacture for Instant
photographic or peel-apart film articles where the substance
would have been subject to a TSCA §5{e) or 5(f) order Is a
level 1 violation, per-day.
Violation of the recordkeeping provisions of this exemption
1s a level 3 violation, one-day except as specified on page
26 of the policy.
Noncompliance with Polymer Exemption Restrictions
Violations regarding the submission of test data with the
exemption application is a level 1 violation, per-day.
Violations of the recordkeeping provisions of the polymer
exemption is a level 4 violation, one-day.
All other violations of the polymer exemption would be
charged as a failure to submit a PMN.
Producti on
Production of a chemical substance not subject to a TSCA §5(e)
or 5(f) order or exemption after submission of a PMN but
prior to the expiration of the PMN review period is a level
3 violation, per-day.
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Producti on of a chemical substance after submission of a PMN
but prior to the expiration of the PMN review period when
the substance becomes or would have been the subject of a
TSCA 55(e) or 5(f) action or the substance was distributed to
consumers is a level 2 vioTTtion, per-day.
Production of a chemical substance prior to the expiration of
the PMN review period when the substance becomes or would have
been the subject of a TSCA § 5 (e) or 5(f) action and the substance
was distributed to consumers is a level 1 violation, per-day.
Other Violations
Any other violation not listed above 1s a level 4 violation,
per-day.
The third step in selecting the base penalty for a spe-
cific violation from the matrix 1s to determine the violation's
position on the extent axis. Extent 1s based on the amount of
substance involved in the violation and the nature of the
violation. The following table is to be used to determine
the extent of a violation.
Extent
EXTENT MATRIX*
Nature
Extent Level
A
Major
a
Significant
C
Mi nor
Chemlcal
Control
>2,500 lbs >250 lbs to 2,500 lbs >0 to 250 lbs
>1,134 kg >113.4 kg to 1,134 kg >0 to 113.4 kg
Control-	>10,000 lbs >1,000 lbs to 10,000 lbs >0 to 1,000 lbs
Associated >4,536 kg >453.6 kg to 4,536 kg >0 to 453.6 kg
Data-
Gathering
Hazard
As sessment
>7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs
>3,402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg
* Note exceptions listed on page 14 and 15 under Notes for
determining extent.
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Notes for determining extent
1)	Production records will generally serve as the extent
basis in the fallowing violation categories:
All failures to notify EPA when such notification
Is required by 1 aw.
Noncompliance with TSCA §5(e) or 5(f) orders,
rule s, or i n jun ct i ons.
Noncompliance with exemptions under 40 CFR Parts
720 and 723.
Where there are no production records, the penalty will
be assessed at the major extent and may be adjusted if
the firm provides data which can be used to determine
the extent. If the underlying violative conduct does
not relate to production, another more appropriate
basis should be employed to determine extent. If, for
example, the violator disposes of 5,000 pounds of the
substance 1n violation of the terms of a TSCA S5(e)
order, then the amount of the substance disposed,
as evidenced in disposal records,_1s the basis of
the penal ty.
2)	The basis of extent in a commercial use violation will
be the amount of illegally produced substance processed
or used by the violator on a given day.
3)	If the records specified above are unavailable, the
penalty is to be assessed from those records that are
available If possible or at the major extent level.
4)	Violations for withholding information, submitting false
or misleading information, or failure to submit reports
required by a TSCA S5(e) or 5(f) order, rule or injunc-
tion do not lend themselves to extent determinations
based on production amounts. For the purposes of de-
termining per-day penalties under this ERP, 1f the
the study which 1s the subject of the violation in-
volved human monitoring data, the extent 1s major.
If the study which is the subject of the violation
Involved animal laboratory data, the extent is
significant. If the study Involved physical or
chemical properties or environmental fate data, the
extent is minor. This Is consistent with the TSCA
§§8, 12, and 13 Enforcement Response Policy.
5)	Violations Involving genetically engineered microor-
ganisms do not lend themselves to extent determinations
based on the matrix, due to the extremely small amounts
involved. These microorganisms may have the ability to
reproduce, creating a larger environmental hazard.
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Therefore, any violation involving a genetically
engineered microorganism will be considered major
In extent. Likewise, violations involving any genetic-
ally altered or naturally occurring organisms subject
to a SNUR or TSCA §5 \ e J order will be considered major
in extent. In the event the Agency identifies low-risk
categories of organisms, violations Involving low-risk
organisms will De considered significant.
6) All Notice of Commencement violations will be considered
major in extent.
Gravi ty	
Gravity, as used in this ERP, Is dependent upon the nature,
extent and circumstances of the violation.
Per-Day Assessments	
Where per-day assessments are provided for in the Circum-
stances Level section, the base penalty Is calculated for the
first occurrence of a violative activity and assessed for each day
of subsequent occurrence. For example, a manufacturer or importer
is responsible for notifying EPA prior to production or Import-
ation of a new chemical substance. Each day of production or
importation of a new chemical substance in violation of the
notification requirements of TSCA 55 constitutes a new viola-
tion. A day of violation is counted for each day a chemical
substance is produced regardless of the number of batches pro-
duced on a given day. The total amount produced on a given day
would be used when determining extent. If production of a chemi-
cal substance takes place over a number of days before the
manufacturing process 1s complete, production occurs only when
the manufacturing process has been completed. Likewise, a manu-
facturer or importer subject to an order, rule or injunction
under TSCA §5 which directs him to dispose of the substance or
wastes in a particular manner, Is in violation for each day dis-
posal occurred contrary to the requirements of the order, rule or
Injunction. Illegal commercial use violations are assessed under
the same principles. Commercial use violations, however, are
based on the amount of Illegally produced chemical substance used.
Per-day penalties assessed on a dally basis (i.e., calendar
days vs. days of actual production) are generally reserved for
violations of the data-gathering provisions of TSCA §5 where
the Agency needs the data to assess the risks presented by a
chemical substance, or situations Involving imminent hazard.
One-Day Violations	
Violations of the recordkeeping provisions of TSCA §5 are
assessed on a ore-time basis only except where compliance cannot
be determined or noncompliance was intentional. See pages 22.
and 26 for a further discussion of these issues.
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Imminent Hazard	
Upon review of the facts surrounding a violation, the
Agency may make a finding that continued production, sale ana
distribution of a substance may Dresent an imminent hazard to
health and the environment. In the event of such a finding,
the Agency may tafce steps to halt further production, sale and
distribution of the product as well as assess the maximum pen-
alty of $25,000 per day for each calendar day the exposure from
manufacturina and/or commercial use occurred. Thus, 1f the
Agency determined that exposure to a substance found to be an
imminent hazard occurred for 90 days, the penalty would be
90 X $25,000 or $2,250,000.
Gravity Based Penalty		
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent of each violation, 1s to be determined
by using the following matrix:
GRAVITY BASED PENALTY MATRIX
C1rcumstances

Extent


A
3
c

Major
Si qn i f1 cant
Minor
Level s



1
$25,000
$17,000
$5,000
High Range
2
$20,000
$13,000
$3,000
3
$15,000
$10,000
$1,500
Mid Range
4
$10,000
$ 6,000
$1,000
5
$ 5,000
$ 3,000
$500
Low Range
6
$ 2,000
$ 1,300
$200
Whether a penalty 1s to be assessed as a one-day assessment
or as a continuing violation on a per-day basis is addressed in
the Circumstances section and on page 15.
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Adjustlnq the Gravity Based Penalty	
Follow the adjustment factor application instructions as
presented in the general TSCA penalty policy document, "TSCA
Civil Penalty System" of September 10, 1980 at pages 9-16.
Adjustment factors specific to this policy are discussed
below.
Other Factors As Justice Way Require	
Voluntary Disclosure	
Penalty amounts for violations of TSCA §5 will be reduced
when the violations are voluntarily disclosed by the company.
For TSCA §5 violations the penalty reductions for voluntary
disclosure are as follows.
Voluntary disclosure 	253
Immediate disclosure within
30 days of discovery	252
Takes all steps reasonably
expected 	up to 152
Total	up to 652
The reduction for voluntary disclosure and Immediate disclosure
may be made prior to Issuing the Civil Complaint. The Civil
Complaint should state the original penalty and the reduced
penalty and the reason for the reduction.
The Agency wants to encourage voluntary disclosures for
TSCA §5 violations. In order to do this, an automatic penalty
reduction may be made. To be eligible, a firm must make the
disclosure prior to being notified of a pending inspection
and the disclosure cannot be one that is "equired by TSCA
§8(e) or that is made after EPA has received information
relating to the alleged violation. Voluntary disclosure of
a violation will result in a 252 reduction of the penalty.
In some cases, companies have delayed 9-12 months 1n re-
porting a violation. An addi tlonal 252 penalty reduction may
be given to those companies which report the potential violation
to EPA within 30 days of having reason to believe that they may
be in violation. This reduction 1s also applicable to firms
which have changed ownership.
If a company realizes 1t cannot find a chemical which it
is manufacturi ng on the non-CBI Inventory, and for which it did
not submit a PMH, it has reason to believe that it may be in
violation. The time limit begins the moment the company has
reason to believe that the chemical may not be on the Inventory,
not after EPA has confirmed the Inventory status of the chemical.
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Environmental ly beneficial expenditures above and beyond
-hose specifically required under TSCA are allowable penalty
-eductions at the Agency's discretion. Generally, environ-
mentally beneficial expenditures may &e deducted from the
penalty at the Agency's discretion in accordance with the
TSCA Civil Penalty Policy for recall costs and special dis-
posal costs, if such action is requested by EPA or undertaken
by the company independently, but not required by TSCA, a
regulation, order, or TSCA § § 7 or 17 and such action is
conducted 1n a manner satisfactory to EPA.
As an alternative to the deduction of costs for environ-
mentally beneficial expend i tur es, a penalty reduction of up to
151 may be made for voluntarily disclosed violations at the
Agency's discretion is the company takes all steps reasonably
expected/requested by t?A to mitigate the violation. This
includes timely submission of information necessary for EPA
to assess a violation. Timely submission means within 30 days
or a time period agreed upon by EPA and the company. This
reduction is not 1n addition to reductions for environmental
expenditures above and beyond that required by the law, but
is an alternative. This reduction of up to 151 is only appli-
cable to companies which have voluntarily disclosed the
violation and may be taken in addition to the Attitude of the
Violator adjustment found in the TSCA C1v11 Penalty Policy.
If the steps expected/requested by EPA have not been taken
at the time of settlement, this section does not apply.
Future activities may be addressed in accordance with the
Settlement with Conditions Policy.
In some cases, mitigation may not be possible. For example,
if the product was distributed in commerce and has already been
used, there may be nothing the company can do to rectify the
situation. In these cases, no reduction will be given under
this heading. In other cases, if no steps are expected because
cessation of the violative action 1s sufficient, I.e., the
chemical clears the PMN process and OTS makes a finding that
no corrective actions are necessary, EPA may still give the
added 151 reduction for companies that have voluntarily
disclosed the violation, provided the penalty exceeds any
economic benefit gained by the company.
An exaaple of a situation in which EPA may give the addi-
tional 15X reduction 1s one in which a company manufactures
a chemical not on the Inventory and does not file a PMN. The
company notifies EPA of the possible violation, immediately
ceases all manufacture, processing, and distribution until
it files a PMM and the chemical clears the review period
without being a candidate for a TSCA §5(e) or 5(f) action.
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Economlc Benefit
In no cases shall reductions be given if the reduced
penalty does not exceed the economic benefit gained from non-
compliance. EPA should require the company to present infor-
mation concerning economic benefits gained from the violative
action prior to the reduction of the penalty except for the
2 5X/5 0X off for voluntary disclosure. In all cases, EPA wishes
to encourage voluntary disclosure.
Atti tude
The existing adjustment provision for the Attitude of
the Violator In the TSCA Civil Penalty Policy (Septemeber 10,
1980) may also be applied to adjust the penalty by up to 152.
Please note that this adjustment may decrease or Increase the
penalty by 15*. This adjustment applies equally to companies
that voluntarily disclosed violations and those that did not.
A company would generally qualify for a downward adjustment
If it immediately halts the violative activity, takes steps
to rectify the situation and there is no finding of culpa-
bility. However, such a reduction is at the discretion of
EPA.
History of Prior Violation
The Agency will disregard the firm's prior history of
violations in calculating the penalty for a self-disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as indi-
cated in the TSCA Civil Penalty Policy, even if the prior
history results from a violation which was voluntarily
di sc1osed.
Culpability
The culpability of a violator may be taken into account
when a violator does not have control over the violation
charged. An example would be a company importing a chemical
substance froa a foreign manufacturer where the foreign manu-
facturer falsely certifies that the substance Is on the TSCA
Inventory and the company importing the substance only knows
the trade naae of the substance. The importing company must
be able to provide a copy of the written false certification
and show that they were unable to ascertain the Identity of
the substance by any other means. The Agency can reduce the
penalty by up to 25X In such situations. In the event of
further violations of this type, history of prior violation
would not be considered when determining the penalty.
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	Explanation of the Penalty Policy
Nature	
The nature of a TSCA §5 violation depends on whether the
violation deals with chemical control, control-associated
data-gathering, or hazard assessment.
1.	Chemical control regulations are aimed at minimizing
the risk presented by a chemical substance by
placing constraints on how the substance is handled.
Section 5(a)(2) authorizes the Administrator to make
a determination that use of a themlcal Is a signifi-
cant new use and require the manufacturer or Importer
to notify EPA prior to initiating such a use.
Sections 5(e) and 5(f) authorize a wide variety of
chemical control requirements from labeling restric-
tions to manufacturing bans. Section 5(h)(1) author-
izes the Administrator to Impose restrictions upon
the manufacture or processing of a test marketed
substance. Violations of those restrictions that
place constraints or how a substance is handled fall
into this category. Section 5(h)(3) obligates a
firm producing a substance under a research and de-
velopment exemption to give adequate warning to
employees 1f that substance 1s dangerous. This is
also a constraint on a substance's handling and is
included in this category.
2.	Control-associated data-gathering requirements are
the recordkeeping and/or reporting requirements
associated with a chemical control regulation.
These requirements enable the Agency to evaluate the
effectiveness of the regulation and to monitor
compliance. Some requirements In TSCA §5(e) and 5(f)
orders, rules, or injunctions would fall into this
category (I.e., a section 5(e) order that requires the
manufacturer to keep records of all purchases of the
regulated substance). Some test marketing exemption
restrictions would also fall Into this category as
section 5(h)(1)(B) authorizes the Admin1strator to
iapose, among other things, recordkeeping and/or
reporting requirements.
3.	Hazard assessment requirements are used to develop
and gather Information necessary to weigh the risks
and benefits presented by particular chemical sub-
stances and to impose chemical control requirements
when appropriate. This category Includes vt "ations
for failure to notify, withholding information from
EPA or submission of false or misleading information.
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-2 1
Ci rcumstances
Circumstances are used in the penalty policy to determine
the probability of potential harm. In otrer words, a variety
of facts surrounding the violation as it occurred are examined
to determine whether the circumstances of the violation are
such that there is a high, medium, or low potential for harm.
To calculate the penalty first use the nature determination
list to select the appropriate nature category and then
select the appropriate circumstance.
Application of the Circumstances Factor to Section 5
1)	Chemlcal control . Chemical control violations in-
clude noncompli ance with TSCA 55(e) or 5(f) actions,
failure to submit a significant new use notice,
noncompliance with a research and development exemp-
tion restriction on adequate warning, noncompl1ance
with test marketing exemption restrictions on the
actual control of the substance, improper commercial
use of a substance produced fn violation of a TSCA
55(e) or 5(f) order, or noncompliance with any ex-
emption restriction on the use of.a substance found
under 40 CFR Part 723. For these violations, the
Initial circumstance level is based on the severity
of the violation. Circumstance evaluations are
adjusted by the degree of potential environmental
exposure and potential risk posed by the chemical.
2)	Control-associated data-gathering. Control-associ-
ated data-gathering violations Include noncompliance
with the recordkeeping provisions of TSCA §5(e) or
5(f) actions and exemption restrictions under 40 CFR
Parts 720 and 723. For these violations the circum-
stances are dependent on the extent to which the
Agency's ability to monitor and/or evaluate the
risks posed by the substance or the company's com-
pliance with the substantive legal requirements is
Impaired.
3)	Hazard assessment. Hazard assessment violations
Include failure to submit a premanufacturlng noti-
fication and associated commercial use, failure to
submit a notice of commencement, withholding Infor-
mation, submitting false or misleading Information,
and noncompliance with the reporting provisions of
TSCA 55(e) or 5(f) actions.
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When determining whether a PMN is subject to a TSCA §5(e)
or 5(f) action, there are instances where rather than imposing
controls under a TSCA 55(e) order with testing triggered at a
particular production volume or time, EPA requires testing
upfront before manufacture may commence. If the company
refused to either do the testing or withdraw the PMN, EPA
would then unilaterally issue an "adversarial " TSCA §5(e)
order prohibiting any manufacture. This type of case would
be treated as a TSCA § 5(e) or 5(f) action and subject to
higher penalties.
When determining the circumstance level for recordkeeping
violations when EPA has requested the missing records, EPA
must be able to determine compliance from the records which
are provided or the charge would be considered failure to
produce the missing records. Where records are necessary to
determine compliance with a requirement of a TSCA §5 action,
rule, or Injunction and the records cannot be produced, EPA
reserves the right to charge per day penalties.
PMN violations involving chemical substances which meet
a 11 requirements for a polymer exemption under 40 CFR 723.250 ,
except the company did not file for an exemption, will be
assessed at a level 5 circumstance. EPA has determined that
chemicals which qualify for these exemptions are of less
concern as a hazard.
Extent
Extent 1s used to take into consideration the degree,
range, or scope of the violation. The Extent Matrix (pg. 13)
provides for three levels of extent: Major, Significant, and
Minor. The three levels are generally based upon the amount
of substance involved 1n the violative conduct.
Production records will generally serve as the penalty
basfs fn the following violation categories:
*	All failures to notify when such notification Is
required by law.
*	Noncompliance with TSCA §5(e) or 5(f) orders, rules,
or Injunctions and significant new use rules (except
for reporting violations).
*	Noncompliance with test marketing or research and
development exemption restrictions.
*	Noncompliance with exemption restrictions under 40
CFR Parts 720 and 723.
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If a chemical substance is manufactured for commercial
purposes as part of a chemical mixture, the amount of the
chemical substance from which the mixture is made is used to
calculate the penalty. If a chemical mixture made from a
chemical suDstance is incorporated into an article, the
penalty is calculated froo the amount of the chemical sub-
stance used to manufacture the chemical mixture. If the
amount of chemical substance used to manufacture the chemical
mixture is unknown, the amount of chemical mixture will be
used to determine extent. If a portion of a batch containing
an illegally manufactured chemical substance 1s sold/distri-
buted for commercial purposes, the entire batch 1s considered
to be manufactured for commercial purposes and the amount
of the chemical substance used to manufacture the entire
batch is used to calculate the penalty. Likewise, If one
batch of an illegally manufactured chemical substance is
sold/distributed for commercial purposes, all other batches
of the chemical substance are considered to be manufactured
for commercial purposes.
If a firm disposes of a substance 1n violation of a test
marketing restriction or a section 5(e) Injunction, then the
amount illegally disposed is the basis of the penalty.
Violations involving genetically altered, naturally oc-
curring or genetically engineered microorganlsms will all be
placed in the major extent category due to the Agency's
general level of concern over the potential for harm from
unregulated environmental release. In the event the Agency
identifies low risk categories of organisms, violations in-
volving low risk organisms will be placed in the significant
extent 1evel.
It should be noted that if those records specified above
are unavailable, the penalty should be assessed on those
records that are available or where there are no records,
assume the violation is major in extent.
Determining extent for violations involving withholding
information, submitting false or misleading information, or
failure to generate reports as required by a TSCA §5(e) or 5(f)
action requires different criteria. These violations are
assessed for each day the violation occurred beginning from
the day the Information was submitted or should have been
submitted. While the amount of a substance produced has
an effect on the potential exposure of the public or environ-
ment to that substance, the harm is caused by the failure to
submit the data or submit true and complete data. Consistent
with the TSCA §58, 12 and 13 Enforcement Response Policy,
extent 1s determined by the type of data involved in the
violation. If the subject study involves laboratory animal
data, the extent is determined to be significant. If the
subject study involves physleal/chemical properties or
environmenta1 fate data, the extent level is minor.
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The three levels of extent (major, significant and minor)
are based on the potential for harm to health or the environ-
ment. As stated previously, chemical control violations are
considered the most serious due to the fact that risks have
largely been identified and steps have been taken to mitigate
those risks. Thus, the amount of production/disposal necessary
to place a violation into the major and significant categories
is substantially less than the amounts which place a violation
into those same categories for hazard assessment violations or
control-associated data-gathering violations. Hazard assessment
violations impair the Agency's ability to determine the risks
presented by a particular new chemical substance and impose
control requirements. Because the Agency has no way of knowing
whether the substance presents a risk to health or the envi-
ronment, hazard assessment violations are placed between chem-
ical control violations and control-associated data-gathering
violations in terms of the amount of substance necessary to
place a violation in the various extent levels. Control-asso-
ciated data-gathering violations impair the Agency's mission
to mitgate threats to health and and the environment the
least. These violations involve the recordkeeping provisions
of a TSCA §5 action. Nonetheless, they are important for
the Agency to assure compliance.
Application of the Extent Factor to Section 5
1)	Chemical control violations. The Agency will have
either knowledge or concerns that the substance may
De harmful. Thus the potential far harm is greatest
in this category. An amount of a substance that
is considered minor or significant in the two other
categories may be considered major here. A minor
designation covers amounts from 0 to 250 lbs. {0 to
113.4 kg.); a significant designation covers amounts
greater than 250 lbs. to 2,500 lbs. (113.4 kg. to
1,134 kg.); the major designation is assigned to
amounts greater than 2,500 lbs. (1,134 kg.).
2)	Control-assoc1ated data-gathering. Since
production, distribution, etc. Is always allowed,
the penalties escalate more slowly than for the
chentcal control category violations: minor is 0 to
1,000 lbs. (0 to 453.6 kg.); significant is greater
than 1,000 lbs. to 10,000 lbs. (453.6 kg. to 4,536
kg.); major is greater than 10,000 lbs. (4,536 kg.).
3)	Hazard assessment. In this category, the Agency can
neither assume that the substance is harmless nor
harmful. The violations, however, are more serious
than those 1n the control-associated data-gathering
category: minor is 0 to 750 lbs. (0 to 340.2 kg.);
significant is greater than 750 lbs. to 7,500 lbs.
(340.2 kg. to 3,402 kg.); and major is greater
than 7,500 lbs. (3,402 kg.).
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Gravity of the Violation		
Gravity refers to the overall seriousness of the violation.
As used in t>)1s penally system, gravity 15 a dependent variable
(i.e., the evaluation of nature, extent, and circumstances will
yield a dollar figure in the matrix that is the gravity based
pe nal ty) .
Imminent Hazard	 	
Imminent hazard violations require the Agency to make a
finding that a particular violative substance presents an im-
minent hazard to health or the ivironment. Penalties for
violations involving imminent nazards are assessed for each
day the violation continues at the maximum penalty allowable
when a company manufactures and uses the hazardous chemical.
In these cases separate charges, one for manufacture* and
one for commercial use may be assessed.
Per-Day Penalties or One-Pay Assessments	
TSCA 5l6(a)(lJ provides not only that civil penalties may
be assessed Jp to (25,000 but that eacN day a violation con-
tinues is a separate violation for which penalties may be
assessed. For tne purposes of this ERP, per-day penalties will
be assessed for each day a violation of TSCA §5 occurs. If,
for example, a firm is charged with the illegal manufacture of a
chemical substance, each separate day of manufacture constitutes
a violation regardless of the number of batches produced during
that lay. The total amount produced in a day would be used as
the basis for the extent of the violation if a company has more
than one facility illegally producing a substance on a given
day. Likewise, if a firm illegally disposed of a substance, the
penalty is based on the number of days the disposal occurred
regardless of the number of shipments for disposal on a given
day. The total amount of a substance produced or disposed of
on a given day is used when determining extent. Where the
manufacture or processing of a substance takes several days
to complete, the penalty is based only on the day the manufac-
turing or processing was completed. For example, if it takes
3 days to manufacture a substance in violation of TSCA §5,
the penalty would be assessed for the day the manufacture of
the substance was completed (day 3).
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Violatlons which warrant daily penalties are those which
impair the Agency's ability to assess the risks to public
health or the environment. These penalties are assessed from
the date of occurrence to the date of discovery.
Per-day penalties will be assessed for the following viola-
tions:
*	Withholding i nfortna tion or submitting false or mislead-
ing Information
*	Failure to generate reports as required by a TSCA §5(e
or 5(f) action
' Noncompl1ance with TSCA 55(e) and 5(f) orders,
rules, and injunctions (chemical control aspects)
*	Noncompliance with research and development exemption
restrictions (violation of adequate warning and ex-
pert supervision requirements)
' Commercial use of an illegally produced substance
*	Noncompliance with exemption restrictions under 40
CFR Parts 720 and 723 [chemical control aspects)
*	Failure to noti fy
Penalties for recordkeeping violations will be assessed
on a one-time basis. Violations of these types do not gener-
ally pose as great a risk, to public health or the environment.
The violations arise from a single violative act.
One-day penalties will be assessed for the following
violations:
*	Noncompllance with section 5(e) and 5(f) orders,
rules, and injunctions recordkeeping provisions only.
The Agency reserves the right to assess per day pen-
alties for recordkeeping violations when compliance
with a requirement of a TSCA $5 action, rule or
injunction cannot be verified.
" Noncompliance with exemption restrictions under 40
CFR Parts 720 and 723 involving recordkeeping
provi slons.
Notice of Commencement violations. The Agency re-
serves the right to charge a per day violation
in those cases where the notice was intentionally
withheld by the company.
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Multiple Violatlons/Chemica1s	
Multiple violations of a TSCA §5 action, rule, or injunc-
tion will be assessed separately for each distinct violation,
dhere more than one chemical substance is in violation, penal-
ties will be assessed for each violative chemical.
Adjustment Factors				
Voluntary Disclosure
This is an activity which the Office of Compliance Moni-
toring (OCMI wants to encourage. If EPA receives a voluntary
disclosure, the Agency can proceed witfr action to rectify a
situation even if the manufacturer is reluctant. Actions by
EPA to convince a violator to do the "right thing" may include
penalties issued on a per-day basis, TSCA 557 or 17 actions,
or other additional rul e-ma k i ng .
Although OCM considered including the condition that the
manufacturer acted 1n good faith prior to the violation and that
he ceased the violative act as soon as he had reason to know of
the violation, QCM decided not to include this as a condition for
the 25S reduction for the following reasons: 1) If the violation
continues, E?A may assess penalties against the manufacturer for
each day of violation. 2) In calculating the penalties for vio-
lations after the violator knew of the violation, a culpability
factor for those days may be added. 3) If the violator intended
to violate TSCA prior to disclosing the violation, the penalties
for the entire period of violation may be increased based on a
culpability finding. A) If the violator does not act to rectify
the situation, his penalties may be increased based on attitude
if no finding of culpability is made. 5) Irrespective of the
circumstances of the violation, the Agency wants the manufacturer
to report it.
Immediate Voluntary Disclosure
QCH wants to further encourage	prompt reporting. There
fore, an added Incentive 1s provided	so that the Agency is
notified soon after the manufacturer	has reason to know of a
potential violation.
History of Noncompliance
As a further Incentive for the voluntary disclosure of
violations, the Agency has decided to forego the imposition of
penalty Increases for a history of noncompliance in assessing
penalties for voluntarily disclosed violations.
However, a voluntarily disclosed violation does constitute
a violation and is to be used to increase penalties for future
violations which the Agency discovers.
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Oefin1ti ons
Consumer - Any person *tio uses a chemical substance for any
purpose.
Off-site Restrictions - Off-site restrictions are those re-
strictions placed on a substance after it leaves the original
site of manufacture or processing.
On-site Restrictions - On-site restrictions are those restric-
tions imposed upon a Company by EPA through a TSCA §5 action,
rule, or injunction at the site of manufacture or processing.
Recordkeeping - Recordkeeping is that information the Agency
requires the Company to retain at its premises and provide
to EPA upon request.
Reports - Reports are those data the Agency is requiring the
Company to submit to EPA under TSCA §5.
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APPENDIX 1
EXAMPLES
Failure to Notify
Example 1
A company has produced a chemical substance, which is not on
the Inventory, for 5 years, with production occurring on 50
days each year, and 1,000 pounds of the substance produced
on each day of production. The chemical substance is consumed
in another chemical reaction. The company stops production
immediately upon discovery of the violation, voluntarily
discloses the violation within 30 days, submits a PMN within
30 days and takes all the steps EPA requests of them. The
PMN goes through review without any health or environmental
concerns being raised. The company is charged with a failure
to submit a PMN, level 4, significant, per-day.
$6,000 X 5 X 50 = $1,500,000
SOS reduction in penalty warranted - $l,20d",000
Final Penalty - $300,000
Example 2
A company has produced a chemical substance, which is not on
the Inventory, for 4 years with production occurring 50 days
per year, and 8,000 pounds of the substance produced on each
day of production. The chemical substance is further processed
by the company on 100 days per year, 4,000 pounds processed
on each day and sold in an end-use product. The company
discovers the violation, immediately stops production, volun-
tarily discloses the violation within 30 days, submits a PMN
within 30 days and takes all steps EPA asks of them. The
PMN review identifies a substantial environmental concern
and the company subsequently enters Into a TSCA §5(e) consent
order to address this concern. The company is charged with
a failure to submit a PMN, level 1, major, per-day.
4 X 50 X $25,000 - $5,000,000
80X reduction 1n penalty warranted - $4,000,000
Final Penalty - $1,000,000
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Example 3
A company has produced a chemical substance, which is not on
the Inventory, for 9 years, with production taking place 25
days a year, and 3,000 pounds of the substance produced on
each day of production. The chemical substance is incorpor-
ated into a product which is sold to its customers for use
in a consumer product. The company discovers the violation
and reports it to EPA 75 days later, after ft has developed
legal substitute for the illegal chemical substance and has
been notified of a pending inspection. A PrtN is not filed
as the company has no intention of making the illegally pro-
duced substance again. The company produces production
records for the substance only after missing two deadlines
for submitting the records. The company is charges with
a failure to submit a PMN, level 3, significant, per-day.
$10,000 X 8 X 25 = $2,000,000
151 penalty adjustment upward for attitude - $300,000
Final Penalty - $2 , 300,000
Example 4
A company failed to submit a Notice of Commencement to EPA.
The first day of production yielded 3,000 pounds of the
substance. EPA discovered the violation. The company is
charged with a failure to submit a Notice of Commencement,
level 3, significant, one-day.
The company would be charged $10,000.
Example 5
A company produced a chemical substance regulated by a SNUR,
for a significant new use as defined by the SNUR, without
submitting a Significant New Use Notice to EPA. The sub-
stance was Incorporated Into a consumer use product. The
company produced the chemical 9 times, with 3,000 pounds
produced on each occasion. EPA discovered the violation.
The company is charged with a failure to submit a Significan
New Use Notice, level 1, major, per-day.
9 x $25,000 = $225,000
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Example 6
An inspector discovers a study that should have been submitted
in conjunction with a PMN application. The study involved ani-
mal testing data. The chemical substance was produced for 1 year
before the violation was detected. The company is charged with
witholding information, level 1, significant, per-day.
517,000 X 365 » $6,205,000
Example 7
A company produces a chemical substance'under a TSCA §5(e)
order. The order requires the company to train workers and
requires the employees to wear respirators while engaged in the
manufacture of the substance. The inspector discovers that the
company has not conducted training as required and that the
workers do not wear respirators, or have them available, while
engaged in the manufacture of the substance. Production has
taken place on 30 days with 5 ,000 pounds of the substance pro-
duced each day. The company is charged witn two counts, fail-
ure to provide training and failure to require their employees
to wear respirators, level 2, major, per-da'y.
520,000 X 2 X 30 =» $1,200,000
Example 8
A company produces a chemical substance under a TSCA §5(e)
order. The order requires the company to incinerate all
wastes derived from the production of the chemical substance.
An inspector discovers that the company has not incinerated
the wastes as required, but has been releasing the wastes to
water after primary treatment. Disposal took place on 50
days with 2,000 pounds disposed of each day. The company is
charged with failure to follow the restrictions of the TSCA
§5(e) order regarding disposal, level 1, significant, per-
day.
$20,000 X 50 - $1,000,000
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-4-
Example 9
A company produces a chemical substance under a TSCA §5(e)
order. The order requires tne company to either stop pro-
duction or submit a study to EPA after producing 400,000
pounds of the substance. The company submits the study to the
Agency and the study is approved. A subsequent inspection re-
veals that the company had produced 450,000 pounds of the sub-
stance prior to submitting the study, producing 5,000 pounds
of the substance on 10 different days. The company is charged
with violation of a production ban, major, level 1, per-day.
$25,000 X 10 » $250,000
Example 10
A company has manufactured and processed a chemical substance,
which is not on the Inventory, for 8 years with manufacturing
occurring 100 days each year, 5,000 pounds manufactured each
day and processing occurring 200 days each year, with 2,500
pounds processed each day. The processed chemical substance
is incorporated into an end use product. inspector dis-
covers the violation. A review of the chemical by EPA iden-
tifies a substantial environmental concern which would have
placed the the substance as TSCA §5(e) order candidate. The
company is charged with a failure to submit a PMN, level 1,
s ignificant, per-day .
$20,000 X 8 X 100 = $16,000,000
Example 11
A company applied for and recieved a low volume exemption for
a chemical substance. An inspector discovers that the company
produced 1500 kg of the substance in 3 different years with
production occurring on 3 days each year, 500 kg produced
each day. The chemical substance would have had a TSCA §5(e)
order Issued 1f 1t had not been granted a low volume exemption.
The chemical substance was distributed to customers. The com-
pany would be charged with a failure to file a PMN, level 1,
significant, per-day.
$20 ,000 X 3 X 3 - $ 180 ,000
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-5-
E x ample 12
A company produced a chemical substance which is not on the
Inventory, for 5 years, with production occurring on 50 days,
5,000 pounds produced each day. The chemical substance was
further processed for 100 days each year with 2,500 pounds of
the substance processed each day. The finished product con-
taining the chemical substance was distributed to consumers.
The chemical substance was a polymer that otherwise would have
qualified for a polymer exemption. The company is charged
with failure to file a PMN, level 5, significant, per-day.
13,000 X 5 X 50 = $750,000
Example 13
Company A solicited several manufacturers to produce a chemical
substance for them. They were advised by one company that the
substance did not appear on the Inventory and that a PMN would
have to be filed prior to manufacturing. Another company agreed
to produce the chemical for Company A. Company A commercially
used the chemical substance for 5 years, 100 days per year,
processing 3,000 pounds of the substance on each occasion.
EPA discovered the violation at the manufacturing company and
charged the manufacturing company with a failure to file a PMN.
The PMN was filed and no problems were found with the chemical
substance during the PMN review, A subsequent Inspection of
Company A discovered the letter from the manufacturer who had
advised Company A of the status of the chemical. Company A was
charged with commercial use of an illegally manufactured sub-
stance, level 3, major, per-day.
5 X 100 X $15,000 - $7 ,500,000
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VI OLATI UN
LEVEL
PER-DAY/
ONE-DAY
na ruRt
Fail tire to Notify
Failure to submit a PMN not subject to a TSCA 55(e) or 5(f)
order or exemption when the substance was not distributed
to consumers _or further processed for commercial use by the
company.
Failure to sUbmit a PMN not subject to a TSCA §5(e) or 5(f)
order or exemption when the substance was distributed to
consumers or further processed for commercial use by the com-
pany.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action but was not
either distributed to consumers or further processed for
commercial use by the company.
Failure to submit a PMN when the si&stance is or would have
been the subject of a TSCA §5(e) or 5(f) action and the
substance was either distributed to consumers or further
processed by the company.
Failure to submit a PMN for a chemical substance which would meet
all requirements for a polymer exemption under 40 CFR 723.250,
except that the company did not file for an exemption.
Failure to submit a PMN for a chemical substance which would meet
all requirements for a polymer exemption under 40 CFR 723.250,
except that the company did not file for an exemption and the
substance was firther processed for commercial use, distri-
buted to consumers, or released uncontrolled into the envi-
ronment.
Per-day
Per-day
Per-day
Per-day
Per-day
Per-day
Failure to submit a Notice of Commencement.
One-day
HA - Hazard Assessment	CC - Chemical Control	CADG - Control-Associated Data-Gathering
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VIOLATION
Failure to submit a timely Notice of Commencement (early or
late submission, up to 30 days prior to manufacture or 30 to
60 days after manufacture).
Failure to sitomit a timely Notice of Commencement (early or
late submission, more than 30 days prior to manufacture or
more than 60 days after manufacture).
Withholding information or submitting false or misleading
information with regard to a PMN, Notice of Commencement,
Significant New Use Notice, or exemption request.
Noncompliance with TSCA S5(e) or 5(f) Orders, Rults or
Injunctions and Significant New Use Rul"es
Violation of on-site restrictions.
Violation of off-site restrictions where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment.
Failure to submit a Significant New Use Notice when the sub-
stance was not distributed.
Failure to submit a Significant New Use Notice when the sub-
rtance was distributed to consumers.
Violation of production ban or restriction.
Failure to generate reports as required.
LEVLL
PER-UAY/
ONE-DAY
nafuke
One-day
One-day
Per-day
Per-day
Per-day
Per-day
Per-day
Per-day
Per-day
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VIOLATION
Failure to generate reports as required, where thfe substance
was either processed by another firm or distributed to
consumers or released uncontrolled into the environment.
Late submission of required reports where the substance was
not distributed or processed.
Late submission of required reports trttere the substance was
either processed by another firm _or distributed to consumers
or released uncontrolled into the environment.
Withholding information or sii>m1tting false or misleading
informa tlon.
Violation of the recordkeeping provisions where the firm
produces the missing records within 5 days of an EPA request.
Violation of the recordkeeping provisions where the firm
cannot produce the missing records within 5 days of an EPA
reqjest except as specified on page 26 of the policy.
Commercial Use of an Illegally Produced Substance
Commercial use violations will be charged in three circumstances
1.	When a company processes or uses a chemical substance which
it did not manufacture and it has reason to know is not on
the Inventory.
2.	When a chemical substance was manufactured or Imported ille-
gally on just a few occasions and processed over a long per-
iod of time, the s^stance would have been subject to a TSCA
55(e) or 5(f) order, and the activity could have caused
substantial endangerment to health or the environment.
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VIOLATION
Commercial use violations will be assessed as follows:
Violation where the substance was not processed by or dis-
tributed to others after receipt by the user.
Violation where the substance was further processed by or
distributed to others.
Violation where the sii)stance is or would have been the subject
of a TSCA §5{e) or 5(f) action but was not processed by or
distributed to others.
Violation where the substance Is or would have been the subject
of a TSCA §5(e) or 5(f) action and was either processed by
others or released uncontrolled into the environment.
Noncompliance with Test Marketing Exemption Restrictions
Overproduction by 10* or less.
Overproduction of more than 10S would be charged as a failure to
submi t a PMN.
Violation of exposure related, on-site restrictions.
Violation of recordkeeping provisions except as specified on
page 26 of the policy.
Violations of the off-site control provisions of a THE where
the substance wns either distributed to consumers £r was
released uncontrolled in to the environment.
Noncompliance with Research and Development Exemption Restrictions
Violations regarding the labeling of the RAO substance where
the substance was further processed by another firm.
LEVEL
PER-OAY/
ONE-DAY
NA fllKt
Per-day
Per-day
CC
CC
Per-day
CC
Per-day
CC
Per-day
CC
Per-day
One-day
CC
CADG
Per-day
CC
Per-day
CC
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VIOLATION
Violations regarding the labeling of the R40 substance where
the substance was either distributed to consumers or was
released uncontrolled Into the environment.
Please note that any violation of an R8D exemption other
than failure to adequately label the RSD substance, would
cause the charge to be a failure to submit a PMN.
Noncompliance with Low Volume Exemption Restrictions
Violations regarding the notification of customers of the re-
strictions on use of the substance.
t
Violations regarding the failure to notify EPA of any changes
1n site or use of the exempted, chemlcal.
Violations of the recordkeeping provisions of the low volume
exemption except as specified on page 26 of the policy.
Violations of the 1,000 kg. production limit would be viewed
as a failure to submit a PMN.
Violations regarding the failure to maintain required exposure
controls.
Noncompliance with the Instant Photographic and Peel-Apart
Film Article Exemption Restrictions
Failure to 11ml t manufacturing and processing to s1te(s)
listed in the exemption application.
Distribution 1n commerce or use of a peel-apart film article
containing a new chemical substance prior to its being cleared
through the PMN process would be considered a failure to
submit a PMN and subject to the penalties thereunder.
LEVEL
PER-DAY/
ONE-DAV
NATURE
Per-day
CC
Per-day
CC
2
3
Per-day
One-day
CC
CADG
Per-day
CC
Per-Oay
CC
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VIOLATION
Failure to follow the conditions of manufacture for Instant
photographic or peel-apart film articles where the substance
would not have been subject to a TSCA §5(e) or 5(f) order.
Failure to follow the conditions of manufacture for instant
photographic or peel-apart film articles where the substance
would have been subject to a TSCA 55(e) or 5(f) order.
Violation of the recordkeeping provisions of this exemption
except as specified on page 26 of the policy.
noncompliance with Polymer Exemption Restrictions
Violations regarding the submission of test data with the
exemption application.
Violations of the recordkeeping provisions of the polymer
exemption except as specified on page 26 of the policy.
All other violations of the polymer exemption would be
charged as a failure to submit a PMM.
Production
Production of a chemical substance after submission of a
PMN but prior to the expiration of the PMN review period.
LEVEL
PLK-OAY/
ONE-DAY
NATUHE
Per-day
CC
Per-day
One-day
CC
CADG
Per-day
HA
One-day
CADG
Per-day
HA
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VIOLATION
Production of a chemical substance after submission of a PMN
but prior to the expiration of the PMN review period when
the substance becomes or would have been the subject of a
TSCA §5(e) or 5(f) action or the substance was distributed to
consumers.
Production of a chemical substance prior to the expiration of
the PMN review period when the substance becomes or would have
been the s»i>ject of a TSCA 55(e) or 5(f) action and the s^stance
was distributed to consumers.
LEVEL
Other Violations
Any other violation not listed above.
PER-OAT/
ONE-DAY
Per-day
Per-day
NATURE
Per-day
EXTENT MATRIX
Nature	Extent Level
A	B
Major	Significant	Minor
Chemical	>2,500 lbs >250 lbs to 2,500 lbs >0 to 250 lbs
Control	>1,134 kg >113.4 kg to 1,134 kg >0 to 113.4 kg
Control-	>10,000 lbs >1,000 lbs to 10,000 lbs >0 to 1,000 lbs
Associated >4,536 kg >453.6 kg to 4,535 kg >0 to 453.6 ki
Data-
Gathering
Hazard	>7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs
Assessment >3,402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg
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GRAVITY BASED PENALTY MATRIX
Ci rcums tances

Extent


A
B
C

Major
Significant
Minor
Levels



1
High Range
2
$25,000
$20,000
$17,000
$13,000 ,
$5,000
$3,000
3
Mid Range
4
$15,000
$10,000
$10,000
$ 6,000
$1,500
$l,nr)0
5
Low Range
6
$ 5,000
$ 2,000
$ 3,000
$ 1,300
$500
$200
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APPENDIX B
§ 8 § 12 and § 13 ENFORCEMENT RESPONSE POLICY
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MAY I 5 1987
RECORDKEEPING AND REPORTING RULES
TSCA SECTIONS 8, 12 AND 13
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U.S. ENVIRONMENTAL PROTECTION AGENCY
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Reporting and Recordkeeping Rules Enforcement Response Policy
CONTENTS
Int roduct ion
Summary of Requirements/Rules Covered	1
Determining the Level of Action	
Notice of Noncompliance 	 3
Administrative Civil Penalty 	 3
Injunctive Action 	 4
Criminal Sanctions 	 4
Mu11 i pie Remed i es	5
Assessing an Administrative Penalty	'
Summary of the Penalty Policy . . . 		6
Explanation of the Penalty Policy 	 16
Appendix 1: Caps for Per Day Violations
Appendix Z: Examples
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INTRODUCTION
Section 8 of the Toxic Substances Control Act (TSCA) author-
izes EPA to require chemical manufacturers, importers and pro-
cessors to keep records and to report certain information. TSCA
§12 requires the submission to EPA of information about chemical
exports. The TSCA §13 rule requires the submission of certifica-
tion statements concerning import shipments of chemical substances.
These reporting and recordkeeping provisions have similar types
of requirements, and therefore, similar types of violations. For
this reason, this Enforcement Response Policy addresses all these
provisions as TSCA reporting and recordkeeping requirements.
Failure to comply with the recordkeeping and or reporting
provisions of TSCA is a violation of TSCA §§15(3)(A) and 15(3)(B)
and subject to the remedies in TSCA §16.
Summary of Requirements/Ru1es Covered	
TSCA §8{a) Inventory - Required reporting during 1977 by persons
who manufactured and/or imported reportable chemicals. (At this
date, these violations are most likely failures to report or
falsified reports.) (40 CFR 710)
TSCA §8(a) Inventory Update - Requires reporting by persons wtio
manufacture or import ch emi ca1 substances which are on the TSCA
Chemical Inventory in quantities greater than 10,000 lbs. at a
specific site. Small businesses and certain classes of chemicals
are excluded. (51 FR 21438, June 12, 1986, 40 CFR 710)
TSCA 58(a) Preliminary Assessment Information Reporting Rule
(PAIR) - Requires reporting by persons who manufacture or im-
port Tisted chemicals in quantities greater than 1,100 lbs.
per site. Small businesses are excluded. (47 FR 26992,
June 22 , 1982 , 40 CFR 712)
TSCA $8(a) Asbestos Reporting - Required reporting by persons
who mined, manufactured, imported , or processed asbestos by
November 1, 1982. Exemptions included small businesses, dis-
tributors, and builders. (47 FR 33198, July 30, 1982, 40 CFR 763)
TSCA §8(a) Chemical Specific Rules
TSCA §8(a} P-T8BA, P-TBT, P-TBB - 40 CFR 704 .33
TSCA §8 (a) Chlorinated naphthalenes - 40 CFR 704.83
TSCA §8(a} Chlorinated terphenyl - 40 CFR 704 .85
TSCA §8(a) Hexachloronorbornadiene - 40 CFR 704 . 142
TSCA §8(a) 4,4'-methy1enebis(2-chloroani1ine)(MBOCA ) -
40 CFR 704.175
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TSCA §8(a) Polybrominated biphenyls (PBBs) - 40 CFR 704.195*
TSCA 58(a) Tris (2,3-dibromopropy1) phosphate - 40 CFR 704.205*
* These rules have been "sunsetted" and replaced by SNUR's.
TSCA 58(c) Alleged Significant Adverse Reactions - Requires
persons who manufacture, Import, process, or distribute chem-
ical substances or mixtures in commerce to keep files of alle-
gations of significant adverse reactions and provide this In-
formation to EPA upon request. Exemptions include persons
whose activities consist of mining or other solely extractive
functions; processors who are not also manufacturers 1f none
of the processors' sites are engaged in activities described
in SIC 28 or SIC 2911; and persons who are solely distributors
or retailers. (48 FR 38178, August 22, 1983, 40 CFR 717;
amended 50 FR 46766, November 13, 1985, 40 CFR 717)
TSCA 58(d) Health and Safety Studies Submission - Requires
persons who manufacture, import, process, or propose to manu-
facture, import, or process listed chemicals to submit lists or
copies of unpublished studies to EPA. (47 FR 38780, September
2, 1982, 40 CFR 716 amended September 15, 1986, 51 FR 32720)
TSCA §8(e) Substantial Risk Reporting - Requires persons who
manufacture, i mpo rt, process, or distribute in commerce a chem-
ical substance or mixture and who obtain "new" information which
reasonably supports the conclusion that such substance or mix-
ture presents a substantial risk of injury to health or the en-
vironment to report such information to EPA within 15 days.
(Policy Statement, 43 FR 11110, March 16, 1978)
TSCA §12 Exports - Requires persons who export chemicals subject
to final and certain proposed rules and orders under sections
4, 5, 6 and 7 of TSCA to notify EPA of the country of destina-
tion the first time a chemical is shipped to that country during
a calender year. (45 FR 82844, December 16, 1980, 40 CFR
707.60)
TSCA 513 Imports - Requires persons who import chemical sub-
stances to certi fy that each shipment is in compliance with TSCA
or is not subject to TSCA. (48 FR 34734, August 1, 1983, 19 CFR
12.118 through 12.127 and 127.28 amended, and 40 CFR 707.20)
Future TSCA §8 Rules - This policy also covers all future
rul es promul gated urTder TSCA §8 or amendments to the above
ru 1 es.
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DETERMINING THE LEVEL OF ACTION
Enforcement alternatives include a notice of noncompliance,
a civil penalty, injunctive relief, criminal action, or some
combination of these actions.
Notice of Noncompliance	
A notice of noncompliance (NON) is appropriate where:
(1)	the violation is a first-time violation of TSCA §§12 or 13
where there are no other TSCA violations for the shipment or
(2)	minor violations of TSCA 58 as specified below where the
violator has not received a previous NON for a violation
of that particular subsection. Violations of TSCA §8
which warrant NON's are:
0 Minor technical omissions, i.e., failure to supply
required ncncitical information (such as, the phone
number of a technical contact).
0 Failure to use certified mail in making a notification
(as requi*ed by a rule) ;
0 Report sent to incorrect address but correctly identified
as a TSCA §8(_) submission;
0 Report sent to correct address but not identified as a
TSCA §8(_) submission;
Admi ni stratTve" Civil Penalty	~~
An administrative civil penalty will be the appropriate
response for most violations of these regulations.
Concu rrence
Civil penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring of the Office of Pesti-
cides and Toxic Substances prior to initiating a civil adminis-
trative penalty for TSCA §§8, 12 and 13. Reductions for settle-
ment purposes require the concurrence of OCM as well and must
be in accordance with the TSCA Penalty Policy and this ERP.
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Each reduction must be justified in the consent agreement and
final order and specific dollar amounts attributed to each re-
duction. Headquarters may relax concurrence requirements on
a Region by Region basis after the Regions have gained experi-
ence with actions under these rules and the ERP.
Injunctive Action	
Injunctive action under TSCA may be appropriate in certain
circumstances. Although §17 of TSCA can be a very effective
tool in obtaining compliance, it is also more resource inten-
sive than a civil penalty action. In addition, it has been
the Agency's experience that a civil penalty action is usually
sufficient to obtain compliance. For these reasons, the Agency
believes that the use of TSCA §17 remedies generally should
be limited to those instances where a civil penalty action will
not result in sufficiently swift compliance to protect human
health or the environment. For ex ampie, injunctive action may
be used to require a company to maintain records where the atti
tude of the violator indicates that this would not be done
otherwise or where there is a repeated history of failure to
keep records.
Criminal Sancti ons
Criminal sanctions pursuant to TSCA §16(b) are the most
serious sanctions available for violations of the recordkeeping/
reporting rules. Accordingly, criminal sanctions may be sought
in situations that -- when measured by the nature of the conduct,
the compliance history of the subject(s) or the gravity of the
health or environmental consequences -- reflect the most serious
cases of misconduct.
Several actors distinguish criminal cases from administrative
or civil actions. First, criminal sanctions will ordinarily be
limited to cases in which the prohibited conduct is accompanied
by evidence of "guilty knowledge" or intent on the part of the
prospective def e rid a nt ( s ) . TSCA imposes criminal penalties only
for violations of the Act which are committed "knowingly or
wil lful ly".
A second factor to consider is the nature and seriousness of
the offense. As a matter of resource allocation, EPA will inves-
tigate and refer only the most serious forms of misconduct. Of
primary importance to this assessment 1s the extent of environmental
contamination or human health hazard that resulted from, or was
threatened by, the prohibited conduct. Also of significance is
the impact, real or potential, on EPA's regulatory functions.
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Third, the compliance history of the individual(s) or per-
son(s) for a potential criminal case is important. Criminal
sanctions become more appropriate as incidents of noncompliance
increase. While not a prerequisite , a history of noncompliance
will often indicate the need for criminal sanctions to achieve
effective individual deterrence.
Multi pie Remed i es
There may be unusual instances where a particular situation
will present facts that suggest that more than one final action
should be taken. OCM does not encourage the use of multiple re-
medies for the reasons discussed below. The purpose of this
Section is to outline when multiple remedies are appropriate.
Criminal Sanctions
Simultaneous civil and criminal enforcement proceedings are
legally permissible, United States v. Kordel , 397 U.S. 1, 11
(1970), and on occasion are clearly warranted. These cases
should be the exception rather than the rule. When parallel
proceedings are contemplated, please refer to the Office of En-
forcement and Compliance Monitoring guidance on parallel proceed-
ings (January 23, 1984 ).
Notice of Noncompliance	
In general, a notice of noncompliance should not be used in
conjunction with any other final remedy. Where a particular
situation presents several violations, some of which would merit
notice of noncompliance, while others would merit civil penalties
no notice of noncompliance should be sent. Instead, an adminis-
trative penalty action should be initiated, pleading all viola-
tions, with no penalties for minor infractions which would other-
wise warrant an NON.
Civil Administrative Penalties and Specific Enforcement	
The criteria outlined in this section anticipate that civil
penalties and specific enforcement (injunctive action) will be
used sequentially. There may, however, be instances where the
concurrent use of these remedies is appropriate. If the Region
deems this to be appropriate in any case, it should consult with
OCM and OECM before bringing either action.
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ASSESSING A CIVIL ADMINISTRATIVE PENALTY
Summary of the Penalty Policy
Background	
The TSCA Civil Penalty Policy, published in the Federal
Register on September 1 0, 1980, establishes a system tor deter-
mining penalties in administrative actions brought pursuant to
TSCA §16. Under that system, penalties are determined in two
stages: (1) determination of a "gravity based penalty" (GBP),
and (2) adjustments to the gravity based penalty.
To determine the gravity based penalty, the following factors
affecting a violation's gravity are considered:
° The nature of the violation.
0 The "extent" of environmental harm that could result
from a given violation.
0 The "circumstances" of the violation.
These factors are incorporated in a matrix which allows de-
termination of the apppropriate gravity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made in con-
sideration of these other factors:
0	Culpability,
0	History of such violations,
°	Abi11ty to pay ,
°	Ability to continue in business, and
0	Such other matters as justice may require.
The TSCA Civil Penalty Policy system provides a framework
for the development of individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the GBP Matrix to assess penalties for
specific violations of TSCA §§8, 12 and 13 and regulations
promulgated pursuant to these sections.
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Applicabi1ity	
This policy is immediately applicable and should be used
to calculate penalties for all administrative actions concern-
ing TSCA §§8, 12 and 13 instituted after the date of this policy,
regardless of the date of violation. Pending cases should be
reviewed to determine whether the penalty calculated under this
policy is lower than the penalty in the civil complaint. If
this policy yields a lower penalty, an amendment to the com-
plaint should be made to substitute the lower penalty. This
policy should not be used to raise penalties in existing actions.
No case should be settled for an amount higher than the penalty
which this policy would yield.
Calculation of the Gravity Based Penalty	
Penalties for TSCA §§8, 12 and 13 violations vary depending
on tne extent, circumstances, whether penalties are to be calcu-
ated as one day assessments versus per day assessments, and by
apping the number of days for which a violation may be assessed
as appropriate. In establishing each of these, the Agency con-
sidered the following factors in a comparative manner:
0 Impact on the Agency's decision making process.
° Relative degree of harm caused by failure to comply.
0 Timeframes in which the Agency decision making process
general ly occurs.
0 Time to generate information not reported.
0 Relative costs of studies.
° Likelihood that sufficient information is available from
other sources.
0 Type of information involved, i.e., human exposure versus
animal toxicity studies and allegations versus actual data.
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent of each violation, is to be determined
by using the following matrix:
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EXTENT
CIRCUMSTANCES
A
MAJOR
B
SIGNIFICANT
C
MINOR
Levels
1
High Range
2
$2 5,000
$2 0,000
$17,000
$13,000
$5,000
$3,000
3
Mid Range
4
$15,000
$10,000
$10 ,000
$6,000
$1,500
$1 ,000
5
Low Range
6
$5 ,000
$2,000
$3,000
$1,300
$500
$200
After determining the initial or "base penalty" from the -
trix for the first day of violation, add the penalty for eatf
tional day of violation based on the instructions in the "Penalty
for Each Day of Violation" heading. Whether a penalty is to be
assessed as a one day assessment or as a continuing violation on
a per day basis is included in the Circumstances sections. Days of
violation are based on calender days, not workdays.
Nature
A violation may be either chemical control, control-asso-
ciated data gathering, or hazard assessment in nature. For pur
poses of assessing a penalty, the nature of a recordkeeping/
reporting violation is "hazard assessment."
Ci rcumstances
The first step in selecting the base penalty is to deter-
mine which level on the circumstances axis applies to the
violation.
The circumstances axis of the GBP matrix reflects the
probability that harm will result from a particular violation.
For recordkeeping and reporting rules, violations rank as fol-
lows on the circumstances axis:
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C I RCUMSTANCE LEVEL
Emergency
Contani nati on
Chemi cal
L F V r L 1 Nonreportino for TSCA §8(e)
Nonreporting for TSCA § 8 (e )
Incident of Environmental
Nonreporting for TSCA §8(d)
Nonreporting for TSCA §8(c)
Nonreporting for TSCA §8(a)
Specific Rules
Nonreporting for Inventory Update
Nonreporting for Inventory
Failure to keep records [not TSCA § 8(c ) ]
Failure to record TSCA §8(c) allegation
False/incorrect/misleadlng reporting
LEVEL 2 Failure to maintain records/report in a
manner that meets the standard required in
the rule. TSCA § 8(c ) violations are level
3.
Per day
One day
Per day
Per day
Per day
One day
One day
Per day*
One day
Per day*
One day
Failure to report under TSCA §8(d) involving
omission of study in list of studies which a
manufacturer or processor knows of but which
i s not in his possessi on.
LEVEL 3 Failure to report, completely after EPA has
requested missing information or a correc-
tion of erroneus information.
One day
Per day*
Failure to maintain TSCA $8(c) records/	One day
report in a manner that meets the standard
required in thp r u 1». Assess one violation
where all allegations are filed but not in
the manner presri bed.
TSCA ^13 Violation (first or otherwise)	One day
where a positive/negative/no certification
was submitted but the chemical does not com-
ply with other TSCA provisions.
LEVEL 4 Late reporting - For definition of late	Per day*
reporting parameters, see the Compliance
Monitoring Strategy for each rule. Does
not apply to the original Inventory Rule,
TSCA §12 and TSCA §13.
TSCA §12 violations after company has	One day
received a pre/ious notice of noncompliance
for a violation of TSCA §12.
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TSCA §13 violations where a negative/no cer- One day
t i f ication is submitted but the chemical is
subject and chemical is in compliance with
all other TSCA provisions as specified in
the TSCA §13 regulation and the company has
received a previous notice of noncompliance
for a violation of TSCA §13.
LEVEL 5 No violations are level 5.
LEVEL 6 Minor technical omission - Example: omitted One day
name of technical contact but included title
and phone number so the Agency was able to
reach the correct person. (See Notice of
Noncompli ance.)
TSCA §8 report sent to incorrect office and One day
was not identified as a TSCA §8(_) submis-
sion as required.
TSCA §8 report sent to incorrect office and One day
was identified as a TSCA §8 report after
company has received a previous notice of
noncompliance for a violation of the same
subsection.
TSCA report sent to correct office hut
not identified as a TSrA report a
company has received a previous notice of
noncompliance for a violation of the same
subsection.
One day
Failure to keep records showing that the
manufacturer is not subject to reporting
under the TSCA §8(a) Inventory Update
Rule.
One day
Extent
The second step in selecting the base penalty for a specific
violation from the matrix is to determine its position on the
extent axis.
This axis of the GBP matrix reflects the extent of potential
harm caused by a violation. In the case of recordkeepfng/reporting
rules, harm is defined as the inability of the Agency to carry out
its risk assessment responsibilities under TSCA.
* One day for Inventory Update, Inventory, TSCA §12, TSCA §13,
TSCA §8(e) EIEC's, and TSCA §R(d) involving lists of studies
which a manufacturer or processor knows of but which are not
in his possession.
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EXTENT LEVEL
MAJOR	Violations of TSCA §§8(c), 8(d), or 8(e)
which involve information which directly
interferes with the Agency's ability to address
situations involving potential imminent hazard,
unreasonable risks, or substantial endangerment
to health or the environment.*
Violations of TSCA § § 8(d ) and 8(e) involving
h uma n data.
Violations of TSCA $8(e) involving information
on emergency incidents of environmental contam-
ination (E IEC) .
All Circumstance Level 2 violations.
All Circumstance Level 6 violations.
SIGNIFICANT	Violations of TSCA §§8(d) and 8(e) involving
anima1/a quatic studies, environmental monitor-
ing, workplace monitoring (not invasive human
monitoring), and any other study not addressed
in the major or minor extent level.
Violations of CA1R, PAIR, TSCA §8(a) chemical
SDecific rules, TSCA §8(c), Inventory, and
Inventory Update Rule except Level 2 or Level
6 violations.
Violations of TSCA §12.
Violations of TSCA ^13.
MINOR	Violations of TSCA §8(d) involving physical/
chemical properties or environmental fate data.
* This determination must have written concurrence from OPTS.
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Per Day Assessments		
Wnere per day assessments are provided for in the Circum-
stances Level section, the base penalty is calculated for
the first day of violation and per day penalties are assessed
for each subsequent day of violation based on the following
f o rm u 1 a :
Violations Involving Potential Imminent Hazard/Substantial
Endanger me nt Situations/Unreasonable Histc?
Base X Each day of violation = Penalty
Pena1ty
TSCA $8(e)
Base + (No. of days of violation - 1) x base penalty _ penalty
Penalty	30
TSCA $8(a) Chemical Specific
Base + (No. of days of violation - 1) x base penalty = Penalty*
Penalty	360
All others
Base + (No. of days of violation - 1) x base penalty = Penalty*
Penalty	180
* The number of days of violation cannot exceed caps as
designated in the following section.
Caps on Number of Days for Penalty to be Assessed Per Violation
TSCA
§8(e)
No
cap

TSCA
§8 (d)
5
ye a r
cap


3
yea r
cap


1
ye a r
cap
TSCA
58(c)
1
yea r
cap
TSCA
ay
co
1
year
cap
Specific
PA IR
C A1 R
1 year cap
1 yea r cap
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Determining Number of Violations	
Multiple penalties are to be used if there is more than
one violation of the same rule or violations of different rules.
Violations will be determined as follows:
TSCA
§8(a)
I nvento ry
Pe r
Chemi cal


TSCA
§8 (a)
Inventory Update
Per
Chemi cal
Pe r
Site
TSCA
§8 (a)
PAIR
Pe r
Chemi cal
Pe r
Site
TSCA
§8 ( a )
CAIR
Per
Chemical
Per
Site
TSCA §8(a ) Chemical Specific	Per Chemical (Per Chemi-
Rules	cal Per Site if Site-Spe-
cific Reporting Is R e-
qu i red)
TSCA §8(c) Failure to Keep	Per Allegation Submitted
Records	to Company and Not Filed
TSCA §8(c) Failure to Keep	Per Requirement Not Met
Records as Required	Per Firm
TSCA
§8(c ) Repo rt
Per Allegation Not Repor
TSCA
§8 (d )
Per Study Per Chemical
TSCA
§8(e)
Per Type of Reportable
Effect or Event Per
Chemi cal
TSCA
§12
Per Chemical Per Coun-
try Per Year
TSCA
§13
Per Shipment Per Port
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Determi ni ng the Gravity Based Penalty	
The circumstances level and the extent category for each
violation will define a base penalty in the matrix. For those
violations designated as per day in the circumstances matrix,
calculate the penalty as indicated under per day assessments,
taking into account the caps on the number of days the penalty
is to be assessed. This total penalty should be entered on line
1 of the TSCA Civil Penalty Assessment worksheet and adjusted
by the appropriate factors discussed in the TSCA Civil Penalty
System and this policy.
Adjustment Factors			
The TSCA Civil Penalty System discusses appropriate adjust-
ment factors. In addition, adjustment factors specific to this
policy are discussed below.
Voluntary Disclosure (Other Factors as Justice May Require)	
The ERP establishes fixed percentage reductions in penal-
ties for voluntary disclosure of violations for the following
sections only: TSCA §8(a) Inventory Rule, TSCA §12, and TSCA
§13. For all other sections, the voluntary disclosure of a
violation is to be treated as a late report, and therefore,
the violator receives a substantial reduction since the
circumstance level moves from Level 1 to Level 4.
For TSCA §§8(a) Inventory Rule, 12 and 13, the adjustment
factors for voluntary disclosure is as follows:
The Agency will not consider disclosure voluntary if the
company has been notified of a scheduled inspection or the
inspection has begun. Information received after these
events will be considered as failure to report/file.
However, if, for example, an inspector is conducting a TSCA
§8 inspection at an establishment, and the company voluntarily
discloses a TSCA §13 violation and the inspector would not
have any expectation of discovering such a violation, the TSCA
§13 violation would be considered to be voluntarily disclosed.
This example would also apply to TSCA §12 violations. For
TSCA §12 and §13 violations, if a company discloses addi-
tional violations during or prior to settlement negotiations,
those violations are eligible for voluntary disclosure reduc-
tions. The Region nay deal with this situation through:
Di sc 1 os ur e 	
Immediate disclosure within
30 days of d i scovery 	
25%
25%
TOTAL
50%
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1) an amendment to the original complaint; 2) an additional
complaint; or 3) addressing additional charges in the Consent
Agreement and Final Order.
Economic Benefit
In no case should the final penalty Imposed be less than
the economic benefit. In those cases where the initial penalty
is less than the economic benefit derived from noncompliance,
EPA reserves the right to impose per day penalties up to
$25,000 per day to assure that the penalty is not less than
the economic benefit.
Exposure Reduction (Other Factors as Justice May Require)
In cases warranting per day assessments of the base penalty,
i.e., those involving potential imminent hazard, etc., if the
Respondent has credible evidence by affidavit which shows, for
example, exposure has ceased by all routes of exposure, environ-
mental and/or commercial; that evidence may be considered to
mitigate the penalty. In those cases, the penalty will be as-
sessed at the maxinum base penalty per day during the duration
of the exposure presenting imminent hazard/substantial endanger-
ment/unreason ab1e risk and assessed as a violation not presenting
the potential hazard/risk/endangerment during the time that
the hazard/risk/endangerment had ceased to exist.
Attitude
For TSCA §13 violations, if the company had a system in
place to track import certifications and comply with TSCA
§13 requirements, and a chemical "slips through", a 15% good
attitude reduction may be given as provided for in the TSCA
Penalty Policy. Larger reductions are inappropriate in that
companies are required to comply with certification require-
ments and credit should not be given for attempting to comply
with the law. If a company experiences numerous occasions
where chemicals "slip through" their system, a good attitude
reduction is no longer appropriate.
History of Previous Violation
The Agency will disregard the firm's prior history of
violations in calculating the penalty for a self-disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as indi-
cated in the TSCA Penalty Policy, even if the prior history
results from a violation which was voluntarily disclosed.
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Explanation of the Penalty Policy
Nature		
TSCA §§8 and 12 require that information concerning
chemicals be reported to EPA or kept at the company and made
available to the Agency. TSCA §13 requires importers to certi-
fy that chemicals imported are either not subject to TSCA or
are in compliance with TSCA.
Section 8 information is used by the Agency to evaluate the
potential risks associated with the manufacture and use of a
chemical. This data gathering often occurs at the early stages
of regulatory decision making. Therefore, complete and accurate
information is essential. Incomplete and inaccurate information
will have far-reaching effects on the Agency's risk assessment,
regulatory priority setting, and regulation development processes.
Some information such as TSCA §8(e) information may affect the
Agency's ability to initiate immediate action necessary to pro-
tect health and the environment, e.g., seeking injunctive relief.
In addition, reports under the original Inventory Reporting Rule
establish the basis for what is an "existing" chemical versus
a "new" chemical, the latter being those for which a premanu-
facture notice must be filed and the chemical reviewed by the
Age ncy .
Section 12 collects information about the export of chemicals
subject to certain proposed or final testing or regulatory require
ments under TSCA §§4, 5, 6, or 7. The Agency provides this infor-
mation to the government of an importing country to allow that
country to initiate its own risk assessment process.
The section 13 rule describes procedures for certifying that
imported chemical substances subject to TSCA are in compliance
with TSCA. This information permits the Agency to determine if
importers of chemicals are complying with applicable TSCA regula-
tions.
Circumstances			
The circumstances axis of the G8P matrix reflects the
probability for harm resulting from a particular violaton.
For the reporting rules, the potential harm caused is the harm
to the Agency's regulatory program for controlling health and
environmental risk. For violations of the original Inventory
Reporting Rule, the potential harm is that a new chemical may
be produced with no prior review contrary to the intent of
TSCA because an Inventory Rule violation resulted in a chemical
being placed on the Inventory which was not an "existing" chem-
ical under TSCA. For chemicals which other persons also reported,
the harm deals with the information on the estimated produc-
tion volume and sites of manufacture which the Agency uses in
its risk assessments, including those for TSCA §4 test rule
decisions. For section 12 reporting, the potential harm is
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to the Agency's- ability to carry out its responsibility to
notify other countries. Thus, violations have the potential
to also harm another country's regulatory program.
High Range Violations - Level 1	
Nonreporting/fai1ure to report or to keep records is an
extremely serious violation of these rules. The Agency will have
to proceed with chemical assessment and priority setting, and
perhaps, even regulation development, especially for TSCA §4
test rules, without critical information or without the knowledge
that such informaton even exists. This is true even if a company
reports some information but does not report each study or under-
reports the extent of health effects or number of allegations for
a particular effect. Thus, each report omitted or incompletely
reported will be treated as a separate nonreporting violation.
Fa 1se/incorrect/mis1eading reporting of information is
equally harmful because the Agency is misled in its analysis of
the potential risks posed by the chemical or in the amounts or
types of information available.
TSCA §8(c) violations in level 1 include failure to keep
records and failure to report if the Agency has requested that
the information be submitted. Thus, if a company has received
TSCA §8(c) allegations, but does not maintain TSCA §8{c) records,
and the Agency requests that TSCA §8(c) allegations be submitted
and the company fails to make a submission, there are two viola-
tions - one for the failure to keep records and another for the
failure to report. Even if a company submits most allegations
but not all, each failure to submit an allegation shall be
separately charged and assessed as a failure to report.
TSCA §8 (d) level 1 violations include the following:
Failure to submit unpublished studies in the
manufacturer's, importer's or processor's
possession.
Failure to notify EPA of unpublished studies
the manufacturer, importer or processor
knows of but is not in possession of.
Failure to notify EPA of ongoing studies which
the manufacturer, importer or processor
initiated or sponsored. Includes future studies
required to be reported once they are initiated.
Failure to send EPA the final report of a
study which was listed as an ongoing study.
Incluoes future studies required to be
s ubim tted .
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Failure to submit underlying data to EPA on
EP A 1 s request.
Failure to comply with the TSCA §8(e) reporting requirements
is potentially the nost serious violation of TSCA §8. TSCA §R(e)
reports alert the Agency to new information which may have a
hearing on the Aqency's requlatory efforts. This ERP reflects
thp seriousness the Agency attaches to violations of TSCA §8(e)
by placing no caps on the penalties assessed for these violations.
High Range Violations - level 2
Failure to maintain records or report in a manner that npets
the standard required by the rule has effects similar to falsi-
fied information. 8oth mislead the Agency and are difficult to
detect. Failure to report in a manner that meets the standard
refers to those cases where reporting is essentially complete
and the missing/incorrect information does not impact the
report in such a manner as to mislead the Agency. An example
is the failure to report one ongoing TSCA §8{d) study when
another similar study is reported by the company. Another
example is a small error in reporting production volume, i.e.,
less than an order of magnitude (a factor of 10).
Level 2 also includes a TSCA §8(d) violation involving
the failure to report a study which a manufacturer knows of
but which is not in his possession. The Agency considers this
violation to have less potential harm than other failure to report
violations since the Agency is likely to learn of this study from
other persons reporting.
Mid Range Violations - level 3	
Failure to report completely after EPA has requested missinq
information is a significant violation. Such a violation denies
thp Agency access to information necessary to its analysis of
chemical risks. This type nf violaton is not as serious as the
high ranqe violations because it is usually relatively easy to
detect and therefore easy to remedy. A form, for instance, will
have blank spaces where answers are expected. Even though the
Agency does not have the information, it knows that an information
gap exists, and therefore, is less likely to be misled into making
invalid chemical risk assessments. However, the withholding of
information is a serious impediment to risk assessment, and if
it becomes a widespread practice, it could significantly affect
the Agency's chemical risk assessment processes. Thus, this vio-
lation, while not as serious as a total failure to report or
false or misleading reporting, is still of sufficient severity
to be treated in the higher level of the midrange.
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For T^CA §8(c) files, the failure to maintain reports
as required in the rule, e.g.. files which are present but which
are not cross-indexeH or which are not kept in one location, in-
volves a level 3 violation. In those cases where the company files
this Information, and the Agency requests the information to he
submitted, and information is not submitted because the company's
files result in the information not being discovered during the
company's file search, the failure to submit is a level 1 viola-
tion. The company may also be charged with the level 3 violation.
Please note that failure to file an allegation under TSCA §8(c)
although other allegations are filed constitutes a level 1
failure to keep records violation.
Another level 3 violation involves TSCA §13 violations
where there is a positive/negative/no certification and the
chemical is in violation of other TSCA provisions. TSCA §13
is designed to assure that an importer takes affirmative responsi-
bility in assuring that his shipments comply with TSCA. Where
other TSCA violations are found, a level 3 violation will be
assessed plus appropriate penalties for the other TSCA violations.
Mid Range Violations - Level 4	
Reports which are late can significantly slow or disrupt the
Agency's decision making process. The exact timing may vary on a
rule hy rule basis which will be discussed in the Compliance
Monitoring Strateqies. Lateness is classified in the lower level
of the midranqe circunstanc^s category.
In addition, the Agency has decided to treat reports which
are submitted late as late reporting regardless of the date
of submission, with the exception of reports for the original
Inventory Rule and TSCA §§12 and 13. This decision has been
made to encourage the voluntary disclosure of violations hy
assessing penalties as level 4 instead of level 1. For the
original Inventory Rule and TSCA §§12 and 13, a reduction is
provided for the voluntary disclosure of violations. Reports
submitted or violations disclosed after EPA has notified a
company of a scheduled inspection will be treated as level 1
failure to report violations, except as otherwise indicated
in the Summary of the Penalty Policy.
TSCA §12 violations other than the first violation are
categorized as level 4. The Agency considers TSCA §12 report-
ing to be important to its ability to notify other countries
to which chemicals subject to TSCA rulemaking are being exported.
The potential harm is not to the Agency's decision making process
but to its statutory obligation to notify other countries.
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The Agency considers TSCA §13 violations, other than the
first TSCA §13 violation for which there are no other TSCA viola-
tions, to be mid range level 4 violations. Even if no actual
harm occurs, the violation reflects the Importer's failure to
assure full compliance with TSCA. Failure to certify or filing
a false cert1fication on each shipment circumvents the purpose
of TSCA §13 and could lead to the importation of chemicals
which violate other provisions of TSCA.
Low Range Violations - level 6	
There are no violations which fall within level 5. Level 6
violations include minor technical omissions which do not affect
the Agency's abili.ty to follow up the information either by
contacting someone in the company or consulting outside references.
They are among the least serious because the violation is readily
detected, does not affect initial risk assessment and may only
slightly hinder the Agency's decision making process. In
cases where there is no effect on the Agency, a notice of non-
compliance rather than a penalty may he appropriate. However,
if a company repeats this type of violation, the Agency will
assess a penalty.
Another level fi violation is the failure on the part of a
manufacturer to keep records showing that he is not subject to
reporting under the TSCA §8(a) Inventory Update Rule, which
requires persons who produce less than 10,000 lbs. of a sub-
stance to maintain records documenting that fa-*
Other low range violations include a submission of TSCA
§8 information which is not identified as TSCA §8(_)
information and which is not sent to the correct office.
Also, submitting the information to the incorrect office or
not correctly identifying the information after a previous
Notice of Noncompliance has been issued for a violation of
that section warrants a level 6 assessment. Although the
Agency receives the information, it may take some time to reach
the correct office or to be placed into the review process,
and therefore, the Agency's decision making is delayed or
impeded.
Extent
This factnr reflects thp extent of potential harm to
EPA's hazard/risk assessment process. The Agency relies
on information qathere^ under sections 8(a), 8(c), 8(d),
and 8(e) to nprform risk assessments. The Agency uses
TSCA $R1? and 13 in a different way. TSCA §12 information is
used in or^r to notify foreign governments. TSCA §13 is used
to assure that imoorters verify and certify compliance with
TSCA.
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For risk assessment, information may be related to toxi-
city or exposure, both important in determining risk. In
examining the extent of potential harm, the type of information
is important, i.e., human effects data, human exposure data,
animal data, environmental effects, actual environmental con-
tamination information. Also, scientific studies versus
allegations differ in their importance.
Major Extent	
Violations which directly interfere with the Agency's
ability to address potential imminent hazard, unreasonable
risk, or substantial endangerment to health/environment are
placed in the major extent category. This criteria is appli-
cable to TSCA §§8(c), 8(d), and 8(e). Examples of these types
of violations include: 1) information on injury to humans
where continued manufacture or use poses a potential imminent
hazard; or 2) i nfo "ma t ion on a spill/dumping which is covered
by TSCA §8(e) and which posed(s) an imminent hazard or results
in widespread environmental contamination to which persons
exhibit serious health effects. In the second case, two
violations would be charged, one for the failure to report
the spill and another for the failure to report the health
effects.
Other major extent categories include TSCA §§8(d) and 8(e)
violations involving information on human effects. Such infor-
mation can weigh heavily in the Agency's decision making
process.
Also, violations involving emergency incidents of environ-
mental contamination reportable under TSCA §8(e) are considered
to be of major extent since the Agency needs such information
immediately. Otherwise, the opportunity to provide adequate
protection may be lost.
All level 2 and level 6 violations are placed in the major
extent category.
Significant	
The Agency places slightly less importance on animal studies
as opposed to data reporting effects in humans. Nonetheless,
such information is critical to the Agency's decision making
process. Such tests may be expensive, may take a long time to
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conduct, and require rulemaking by the Agency to obtain them.
For example, if a company fails to report a study it has, the
Agency may decide that such data are needed and proceed to do
unnecessary rulemaking under TSCA §4. Given the time for such
rulemaking and the time needed to conduct tests and submit re-
sults to the Agency, the violation results in a major delay in
the Agency's risk assessment of the chemical and an unnecessary
expenditure in resources, both EPA's and industry's. Please
note that failure to report a study which is required to be re-
ported but which indicates no adverse effects of the chemical
still results in this harm.
The Agency has also decided to place violations involving
exposure related data in the significant category when the
EPA has made a decision that it needs such information for
a specific chemical. Thus, TSCA §§8(d) and 8(e) violations
involving exposure related information as well as violations
of the CAIR, PAIR, and TSCA §8(a) chemical specific rules,
all of which involve exposure related information, are consid-
ered to be significant category violations. Although exposure
information is critical to any risk assessment, the impact on
the Ageny's decision making if one company fails to report and
all other companies comply is less than if one company fails
to submit a toxicity study since it is less likely that another
company will submit the same study. This distinction is
reflected in the establishment of caps for different types of
vi olat i ons.
TSCA §8(c) involves allegations and not actual test data.
However, such information is important to the Agency's decision
making process in that it involves patterns of effects and
generally involves human effects. Therefore, these violations
are categorized as significant.
TSCA §8(a) Inventory and Inventory Update Rules are also
designated as significant. Although info rmat i on under these
rules is not required as a result of the Agency identifying
a specific need for information on specific chemicals, this
information provides exposure related information which is
important to the overall decision making of the Agency in terms
of setting its priorities and deciding what rulemaking to
pursue.
TSCA §12 violations are also considered significant since
such information is necessary for EPA to carry out its responsi
bility to notify other countries of chemicals for which EPA
has taken certain actions, i.e., a TSCA §5 order or a final or
proposed TSCA §§4, 5 or 6 rule. TSCA §13 is significant in
that violations hinder EPA/Customs' ability to monitor ship-
ments for compliance with TSCA.
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Minor
Two tvdps of violations fall into the minor extent level,
I.e., violations o^ TSCA §P(d) involving physical/chemical
properties or onvironmental fate data; and violations of TSCA
§fl(a), failure to keep records showing that a manufacturer is
not subject to reporting under the Inventory Update Rule.
The TSCA §8(d) violations are categorized as minor based on
the relatively low costs of such studies and the time it takes
for the study to be conducted. The TSCA §8(a) violations are
easy to detect upon inspection and Information the company
should already have.
Per Day Penalties or One Day Assessments	
The Agency has elected to use one day assessments for
violations of rules which require reporting for all chemicals
meeting certain criteria (such as exceeding a given production
volume per site) as opposed to information which is not being
requested on a chemical specific basis. In other words, one
day assessments are appropriate in cases where the Agency uses
the information to set priorities and may use it as the need
arises on a specific chemical evaluation but has not affirma-
tively identified a particular chemical for which specific
information is needed.
In those cases where EPA has issued a rule which lists a
specific chemical(s), per day assessments are appropriate because
the Agency has identified a need for the information for risk
identification, risk assessment, or risk management purposes.
Per day assessments also apply to any TSCA §8(e) information
(except EI EC's which do not meet the potential imminent hazard/
endangerment criteria). Although the information is not heing
requested for a specific chemical, it is likely to be used
immediately for risk assessment purposes. Per day assessments
are made for those violations where the continuing violation
continues to impede the Agency's decision making process.
One day assessment is appropriate for a failure to list a
TSCA §8(d) study which a company knows of but which is not in
its possession. Level 2 and level 6 violations are to be as-
sessed as one day. Also, TSCA §§12 and 13 are considered to
be one day violations. As with TSCA §8(e) violations dealing
with an EI EC, violations of these rules do not impede the
Agency's regulatory decision making process in that such infor-
mation would not normally result in rulemaking. However, such
information is necessary for more immediate actions such as
injunctive relief or seizing chemicals which are otherwise in
violation of TSCA, e.g., a TSCA §13 chemical imported in viola-
tion of TSCA §5.
Violations involvinq TSCA §8(c) files, i.e., failure to
record information, are treated as one day violations because
the effect on the Agency's decision making is not critical
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-24-
until the Agency requests the submission of TSCA §8(c) informa-
tion. Once the information is requested, the Agency has a
specific need for the ^formation to make its decisions. There-
fore, "failure to report" violations under TSCA §8(c) are as-
sessed on a per day basis due to their adverse impact on the
Agency's decision making.
Per Day Assessment Calculation	
For violations involving TSCA §8(e) information which directly
interferes with the Agency's ability to address situations in-
volving potential imminent hazard, unreasonable risk, or substan-
tial endangerment to health/environment, the base penalty is to
be assessed for each day of violation. These are the most serious
violations, and therefore, warrant the highest penalties provided
for by the statute.
For other TSCA §8(e) violations, the base penalty is to be
used for the first day of violation. For each day thereafter,
the per day penalty is the base penalty divided by 30. This ad-
justment was selected for the following reasons: 1) these viola-
tions involve significant adverse effects; 2) the Agency has an
immediate need for the information in order to protect the pub-
lic and environment, as reflected in the statute's language to
"immediately notify"; and 3) the timing of the Agency's decision
making process once such data is received.
For TSCA §§8(c) and (d) violations for which per day assess-
ments are to be made, the base penalty is to be used for the first
day of violation and for each day thereafter, the per day penalty
is the base penalty divided by 180. For TSCA §8(a) Chemical Spe-
cific violations the per day penalty is the base penalty divided
by 360. This method was selected in order to provide further
distinction between types of violations and their impact on the
Ayency's decison making process and its mission to protect the
public and the environment.
Caps	
In establishing caps for some violations, the Agency took
into account factors such as the length of time that a violation
continues, the timing of the Agency's decision making process,
the relative costs of studies and the length of time needed if
unnecessary studies are conducted. Please note that the cap
does not refer to a limitation on the time elapsed since the
violation occurred - only a limit on the number of days for
which a penalty is assessed even though a violation continues
for a longer period.
There is no cap on TSCA §8(e) violations. The harm
continues as long as the violation continues.
For TSCA §8(d) studies, which often relate directly to
TSCA §4 rulemaking, the caps depend on the type of study, the
length of time to conduct the study, the relative costs of the
studies, and the timing of the Agency's decision making.
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-25-
For other TSCA §8 violations for which per day assessments
are to be nade, a one year cap is set based on the estimated
time of the Agency's decision maklnq process. This decision
also reflects the fact that TSCA §8(a) requirements are more
exposure oriented than toxicity oriented, and therefore, the
quality of the information is sensitive to time. As indicated
in the discussion on extent categories, exposure information
is important but one company's failure to report may not have
as much of an impact as nonreporting of toxicity information
because the exposure Information is jsed in the context of total
exposure. Therefore, these violations are capped at one year.
A chart is provided in Appendix 1 which indicates the caps
per violation and their maximum assessments. Caps refer to
maximum penalties for each separate violation; they are not
cumulative caps for multiple violations.
Determining Number of Violations	
The number of violations depends on the requirements which
are in each rule. Multiple violations are to be assessed when-
ever more than one rule is violated and for each violation within
a rule. TSCA §8 (a) Inventory violations are assessed for each
chemical for which there is a violation. The Inventory Update
rule requires reporting for each chemical and for each site.
Therefore, TSCA §8(a) Inventory Update violations are assessed
per chemical per site.
Violations of CAIR and PAIR are assessed per chemical per
ji;e. TSCA ^8{a} Chemical Specific Rules violations depend
on the information required by the rule. If the rule requires
site specific information, then violations are assessed per
chemical per site. If the rule requires aggregate information
for each company, then violations are assessed for each chemical
not reported/otherwise in violation.
TSCA §8(c) violations are determined depending on the viola-
tion. TSCA 68(c) "failure to keep records" violations and "failure
to report" violations are assessed per allegation not maintained/
reported. This is because the omission of any allegation may
impact the Agency's decision making process, especially if there
is significant underreporting of allegations. However, a "failure
to keep records as required" under TSCA *>8(c) 1s assessed per plant
site because these violations involve files not maintained as
prescribed but for which the information is available. An alle-
gation consists of each report (i.e., one or more pieces of paper)
whereby an individual/ group submits an allegation to a company.
If one person alleges that six chemicals produced ten effects
in the same report, and the company fails to file the allegation,
this is assessed as one violation. If two persons file separate
reports regarding the same health effect, and the company does
not file the allegations, this constitutes two violations. If
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-26-
a union files a report for 100 persons regarding an allegation,
and the company does not file the allegation, this is assessed
as one violation.
TSCA §8(d) violations are assessed for each required study.
The omission of a single study even if others are submitted may
have a serious impact on the Agency's decisions regarding a
specific chemical. TSCA § 8 (e) violations are assessed per type
of effect per chemical not reported. Omission of one significant
adverse effect even 1f other effects are reported Impedes the
Agency's risk assessment.
TSCA §12 violations are assessed per chemical per country
per year not reported. This decision Mas based on the determina-
tion that the export notification requirement is a one-time
requirement per year for each chemical and for each country of
export. That is, the first time a chemical is exported to a
country, the exporter must notify the country. Subsequent
exports of the same chemical during the same calendar year to
the same country do not require notification.
TSCA §13 violations are assessed per shipment per port
because the U.S. Custons regulation requires a certification for
each shipment, not for each chemical within a shipment. If the
same chemical is imported on the same day to a port in three
separate shipments, there are three violations.
Adjustment Factors	
Voluntary Disclosure	
The Agency considers it important to foster voluntary
disclosures of violations for TSCA §§8, 12, and 13. Most dis-
closures of TSCA §8 violations will be treated as late reporting
and subject to level 4 instead of level 1 penalty assessments,
which provides a voluntary disclosure incentive. For TSCA §8(a)
Inventory violations and TSCA §§12 and 13 violations, explicit
reductions for voluntary disclosure are also provided. It is
important to foster voluntary disclosure of TSCA §8(a) Inventory
violations in order to remove chemicals from the Inventory which
were placed there Illegally. Once the Agency knows of this, it
it can act to correct the violation. Similarly, if violations
of TSCA §§12 and 13 are brought to the Agency's attention, it
can act to remedy the situation, e.g., foreign countries can
be notified or imports in violation of other sections of TSCA
can be identified and appropriate action taken.
Also, EPA wants to encourage companies to conduct Self-
audits and report violations.
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-27-
History of Noncompliance	
As a further incentive for the voluntary disclosure of
violations, the Agency has decided to forego the imposition of
penalty increases for a previous history of noncompliance in
assessing penalties for voluntarily disclosed violations.
However, a voluntarily disclosed violation does constitute
a history of violation and is to be used to increase penalties
for future violations which the Agency discovers.
TSCA Section 13 - Who Issues Notice of Noncompliance/Pena1ty
and to Whom
TSCA §13 nay involve imports in one Region by an importer
of record, who is located in another Region and who uses a
broker. The Notice of Noncompliance/Penalty is to be issued
to the importer of record, not the broker, and by the Region
in which the importer of record is located. This is consistent
with the Inspection Guidelines.
This decision was made for several reasons. If a TSCA §5
inspection is conducted at the importer of record's business,
and there is a chemical which has been imported into three ports
in three other Regions and which is not on the inventory, it is
more efficient to issue a Civil Complaint for the one TSCA §5
violation and three TSCA §13 violations than to issue four sep-
arate Civil CompLaints in four Regions.
A second reason pertains to the location of the hearing.
If one Region issues the complaint to an importer of record in
another Region, there is a problem of travel, both in terms of
time and money, since the hearing will likely be held in the
Region where the importer of record is located.
A third reason deals with the tracking of Notices of Non-
compliance between Regions in order to know if a company has
received its first TSCA §13 Notice of Noncompliance and is
therefore subject to penalties for subsequent violations.
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APPENDIX 1
CAPS FOR PER DAY VIOLATIONS
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CAPS FOR PER DAY VIOLATIONS
ALL CAPS ARE PER VIOLATION
TSCA §8(e) - No Caps
TSCA $8(d)
Nonreportlng/False Reporting
Major, level 1	- $278,333 - 5 yr. cap
Significant, level 1 - $120,322 - 3 yr. cap
Minor, level 1	- $15,111 - 1 yr. cap
Late Reporting
Major, level 4	- $1 1 1 , 333 - 5 yr. cap
Significant, level 4 - $42,467 - 3 yr. cap
Minor, level 4	- $3,022 - 1 yr. cap
TSCA 58(c)
Nonreporting/False Reporting - 1 yr. cap
Significant, level 1 - $51,378
Late Reporting - 1 yr. cap
Significant, level 4 - $18,133
TSCA §8(a) Chemical Specific rules
Nonreporting/Fa 1se Reporting - 1 yr . cap
Significant, level 1 - $34,189
Late Reporting - 1 yr. cap
Significant, level 4 - $12,067
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APPENDIX 2
EXAMPLES
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EXAMPLES
TSCA $8(a) Chemical Specific Rules (PAIR, CAIR, Asbestos, etc.)
Example 1 - A company falls to report. EPA discovers the
violation. Failure to report, level 1, significant.
Discovered after 181 days -	$2 5,500
517,000 + 180 X $17,000 = $25,500
	TCo	
Discovered after 361 days -	$34,000
Discovered after 1,095 days - $34,189 (1 yr. cap)
Example 2 - A company reports late. Late report, level 4,
s i gm f i cant.
Report 181 days late -	$9,000
$6,000 + 180 X $6,000 = $9,000
3T0
Report 271 days late - $10,500
Report 730 days late - $12,067 (1 yr. cap)
Example 3 - A c ompa ny " repo r t s under the rule. EPA later
discovers that the information was falsely reported.
False reporting, level 1, significant.
Discovered after 181 days -	$25,500
$17,000 + 180 X $17,000 = $25,500
360
Discovered after 361 days -	$34,000
Discovered after 1,095 days - $34,189 (1 yr. cap)
Example 4 - A company reports under the rule. The company
later reports that some of the information was inaccurately
reported and supplies EPA with the correct information
within 10 days. Late reporting, level 4, significant.
Reported 181 days late - $9,000
$6,000 + 180 X $6,000 = $9,000
360
Reported 365 days late - $12,067
Reported 1,825 days late - $12,067 (1 yr. cap)
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-2 -
TSCA §8(a) Inventory and Inventory Update
Example 1 - A company fails to report a chemical on the
TSCA Inventory. EPA discovers the violation. Failure
to report, level 1, significant, one-time penalty.
Failure to report - $17,000
Example 2 - A company fails to report a chemical on the
TSCA Inventory. The company is bought by another company
who, upon checking records, discovers the failure to report
and immediately notifies the Agency. Failure to report,
level 1, significant, one-time penalty.
Failure to report - $17,000
Voluntary Disclosure Policy - 50% reduction of penalty.
Amended Penalty - $8,500
Example 3 - A company fails to report 1 chemical at 4 dif-
ferent sites for the Inventory Update. The company is bought
by another company who, upon checking records, discovers the
failure to report and immediately notifies the Agency. Late
reporting, level 4, significant, 4 counts, one-time penalty.
Late reporting, 4 counts - $24,000
TSCA $8(c)
Example 1 - A union contacts EPA complaining that they
submitted 1 report to the company regarding health effects
to 10 workers due to their exposure to chemical X. The
report was presented to the company in accordance with the
rule, and the union provided acknowledgments of receipt by
the company. EPA requested the company to provide all
allegations of health effects due to exposure to chemical
X. The company failed to respond. EPA inspected the com-
pany's TSCA §8(c) files six months later and found none.
Failure to keep files, level 1, significant; and failure to
report, level 1, significant.
$17,000 + $17,000 + 180 X $17,000 = $51,000
	nro —
Failure to maintain a file	-	$17,000
Failure to report (per day penalty) -	$34,000
181 days
Total	551.000
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-3-
Example 2 - EPA requested a company to submit any al-
legations of effects attributable to chemical Y. The
company reported that no allegations of effects of any
kind were made to them. An inspector visited the com-
pany 2 years later and found a file for chemical Y which
included 3 allegations of bird kills attributed to the
chemical. Failure to report, level 1, significant, 3
coun t s.
$17,000 + 364 X $17,000 x 3 = $154,134
180
Failure to report - (1 yr. cap) - $154,134
Example 3 - EPA requested a company to submit any al-
legations of effects attributable to chemical Y. The
company reported that no allegations of effects of any
kind were made to them. A year later they contacted the
Agency and informed us that they just found 4 old al-
legations of human effects attributable to chemical Y
and submitted the allegations within 10 days. Late
submission, level 4, significant, 4 counts.
$6,000 + 360 X $6,000 x 4 = $72,000
180
Late reporting - 361 days x 4 - $72,000
Example 4 - An inspector visited a company and asked to
see the company's TSCA §8(c) files. The company informed
the inspector that any allegations by workers were kept
in the individual workers personnel files. Failure to
keep files in a manner prescribed by the rule, level 3,
significant, one day assessment, no per day penalty. $10,000
Example 5 - An inspector visits a company and when inspecting
their TSCA §8(c) file discovers that the files are organ-
ized by the health effect rather than by the cause of the
health effect. The files are otherwise in compliance with the
rule. Failure to keep files in a manner prescribed in the
rule, level 3, significant, one day penalty. $10,000
-------
-4-
TSCA §8(d)
Example 1 - A company submits a 11st of ongoing studies they
are sponsoring but fails to list a study involving humans.
EPA discovers the violation. Failure to report, level 1,
major.
Discovered after 365 days - $75,556
$25,000 + 364 X $25,000 = $75,556
nro
Discovered after 1 ,095 days - $1 76,944
Discovered after 2 ,000 days - $278 ,333 ( 5 yr. cap)
Example 2 - A company submits late an animal study in the
company's possession during the initial reporting period.
Late reporting, level 4, significant.
Reported to EPA after 365 days - $18,133
$6,000 + 364 X $6,000 = $18,133
	TS7T	
Reported to EPA after 1,095 days - $42 ,467
Reported to EPA after 1,825 days - $42,467 (3 yr. cap)
Example 3 - A company submits an animal study, EPA finds ad-
ditional reportable information that the company intentionally
omitted from the submitted study report. False reporting,
1 evel 1, si gm f i cant.
Discovered after 365 days - $51,378
$17,000 + 364 X $17,000 = $51,378
	TBT3	
Discovered after 1 ,095 days - $1 20, 322
Discovered after 1,825 days - $120,322 (3 yr. cap)
Example 4 - A company submits a 11st of 9 ongoing animal
studies and later submits 10 studies. Late reporting of one
study, level 4, significant.
Submitted to EPA 365 days after list submitted - $18,133
$6,000 + 364 X $6,000 = $18,133
	m—
Submitted to EPA 1,095 days after list submitted	- $42,467
Submitted to EPA 1,825 days after list submitted	- $42,467
(3 yr.	cap)
-------
-5-
Example 5 - A company submits a 11st of studies known to
them but not in tneir possession. The Agency discovers that
the company failed to list a study they had knowledge of.
Failure to report a study the manufacturer knows of but is
not in his possession, level 2, major, one day assessment,
no per day penalty. $20,000
TSCA 58(e)
Example 1 - A company failed to report a spill within the
time period prescribed in the policy. EPA discovers the
violation. Failure to report, level 1, major, one-time
assessment - $25,000
Example ?. - A company failed to report a spill within the
time period prescribed in the policy. The company reports
their failure to EPA a year after the spill occurs. Late
reporting, level 4, major, one-time assessment - $10,000
Example 3 - A company fails to report a study showing human
health effects. EPA discovers	the violation. Failure to
report, level 1, major.
Discovered after 361 days -	$325,000
$25,000 + 360 X $25,000 = $325,000
	TO	
Discovered after 1,081 days -	$92 5 ,000
Discovered after 3,601 days -	$3,025,000
Example 4 - A company fails to report a study showing animal
effects not previously reported. The company later submits
it to the Agency. Late reporting, level 4, significant.
Reported after 361 days -	$78,000
$6,000 + 360 X $6,000 = $78,000
	TO 	
Reported after 1,081 days -	$222,000
Reported after 3,601 days - $726,000
-------
Example 5 - A company submits a study to EPA showing
new animal effects. An inspector conducting an inspec-
tion of the company later discovers reportable information
which was omitted from the study. False reporting, level
1 , s 1 gni fi cant.
Discovered after 1,825 days - $1,050,600
$17,000 + 1,824 X $17,000 = $1,050,600
	rr——
Discovered after 365 days -	$223, 267
Discovered after 3,650 days - $2,084,767
Example 6 - A company fails to submit human health effects
information which is later characterized by the Agency as
showing a potential imminent hazard. EPA discovers the
violation 90 days after the report was due. Failure to
report, level 1, major. Potential imminent hazard finding,
$25,000 per day penalty.
$25,000 X 90 = $2,250,000
EPA discovered the same violation after one year.
$25,000 x 365 = $9,125,000
EPA discovered the violation after one year and the company
presents credible evidence that exposure ceased after 90
days of the due date of the report. The penalty is calculat
as an imminent hazard for 90 days and as a reduced per day
for the TSCA §8(e) failure to report for the period thereaft
$25,000 X 90 = $2,250,000
275 X $25,000 = $229,167
T3
$2,250,000 + $229,167 = $2,479,167
TSCA §12
Example 1 - An exporter which has received no previous TSCA
§12 Notice of Noncompliance exports 30 chemicals to 30 coun-
tries with no notifications. Failure to notify. Notice of
Noncompli ance.
-------
-7-
E x am p1e 2 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports one chemical
to one country 30 times during one calendar year with no
notifications. Failure to notify, level 4, significant. -
$6,000.
Example 3 - An exporter who has previously received a Notice
of Noncomp1iance for a TSCA §12 violation exports one chemical
to one country 30 times during one calendar year, notifying
EPA that 5 shipments had already occurred. Failure to notify,
level 4, significant, voluntary disclosure, more than 30 days
since discovery, 2 5% reduction. - $4,500
Example 4 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports the same
chemical to 30 countries with no notifications within the
same year. Failure to notify, 30 counts, level 4, signifi-
cant. - 5180,000
Example 5 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports the same
30 chemicals to 30 countries with no notifications within the
same year. Failure to notify, 900 counts, level 4, signifi-
cant. - 55,400,000
TSCA Section 13
Example 1 - Company imports a chemical with no certification
and which is otherwise in compliance with TSCA. Failure to
certify, level 4, significant.
First time violation: N0N
Second time violation: $6,000
Example 2 - Second time violator imports a chemical which is
otherwise in compliance with TSCA at 3 ports on the same day
but has no cert ification or an incorrect certification.
Failure to notify, level 4, significant, 3 counts - $18,000
Example 3: Second time violator imports 3 shipments of a
chemical which is otherwise in compliance with TSCA on the
same day to the same port. Failure to notify, level 4,
significant, 3 counts - $18,000
Example 4 - Second time violator imports 30 shipments which
are otherwise in compliance with TSCA but lack a certification.
Import may be to same port or different ports. Failure to
certify, level 4, significant, 30 counts.	$180,000
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APPENDIX C
PMN FORM
-------
Appendix C
PMN Form
-------
0 M B No 2070-0012 Approval Expires 3 3-B€
United Slates
Environmental Protection
Agency
PREMANUFACTURE NOTICE
FOR NEW CHEMICAL SUBSTANCES
AGENCY USE ONLY
Date of receipt
When ^
com pitted
send this
formto A
DOCUMENT CONTROL OFFICER
OFFICE OF TOXIC SUBSTANCES, TS-793
~ U.S. E.P.A.
401 M STREET, SW
WASHINGTON, D.C. 20460
Enter the total number of pagea k
In the Premanufacture Notice "
Document control number EPA case number
GENERAL INSTRUCTIONS
You must provide all information requested in this form to the extent that it is known to of reasonably
ascertainable by you Make reasonable estimates if you do not have actual data
Before you complete this form, you should read the "Instructions Manual for Premanufecture Notification"
(Instructions Manual I
Pari I - GENERAL INFORMATION
You must provide the chemical identity of the new chemical
substance, even if you claim the identity as confidential You may
authorue another person to submit the identity for you, but your
submission will not be complete and review will not begin until
EPA receives this information
Pwl II - HUMAN EXP08URE AND ENVIRONMENTAL
RELEASE
You may need additional copies of part II, sections A and B if there
are several manufacture, processing or use operations that you
will describe in the notice You should reproduce these sections
as needed
Part III - LIST OF ATTACHMENTS
You should attach additional sheets if you do not have enough
space on the form to answer a question fully In part III. list these
attachments, any test data or other data, and any optional
information that you include in the notice
OPTIONAL INFORMATION
You may include in the notice any information that you want EPA
to consider m evaluating the new substance The Instructions
Manual identifies categories of optional information that you may
want EPA to review
CONFIDENTIALITY CLAIMS
You may claim any information in this notice as confidential To
assert a claim on the form, mark (XI the confidential box next to
the information that you claim as confidential To assert a claim in
an attachment, circle or bracket the information you claim as
confidential. If you claim information in the notice as confidential,
you must provide a sanitized version of the notice, including
attachments, to EPA with your submission For additional
Instructions on claiming information as confidential, read the
litetiuctkma Manual.
Indicate below the categories of information you have claimed as
confidential in the notice and the type of notice
1 ~ SUBMITTER IDENTITY
~
PMN
2 ~ CHEMICAL IDENTITY
~
TMEA
3 ~ PRODUCTION VOLUME
D
SNUR
4 ~ USE INFORMATION
~
Exemption —
5 ~ PROCESS INFORMATION

Specify ^



TEST DATA AND OTHER DATA
You are required to submit afl test data in your possession or control
and to provide a description of all other data known to or reasonably
ascertainable by you if these date are related to the health and
environmental effects of the manufacture, processing, distribution
in commerce, use. or disposal of the new chemical substance
Standard literature citations may be submitted for data iri the open
scientific literature Complete test data, not summaries of data,
must be submitted if they do not appear in the open literature
Following are examples of test data and other data You should
submrt these data according to the requirements of §720 50 of the
Premanufacture Notification Rule (40 CFR Part 720)
Teat data
•	Environmental fata data
Spectra (UV, visible, and infrared)
Density of liquids and solids
Water solubility
Melting point/melting range
Boiling point/boritng range
Vapor pressure
Partition coefficient, n-octanol/waier
Biodegradation
Hydrolysis (as a function of pH)
Photochemical degradation
Adsorption/desorption to soil types
Dissociation constant
Other physical/chemical properties
•	Health affacta data
Mutagenicity
Carcinogenicity
Teratogenicity
Acute toxicity
Repeated dose toxicity
Metabolism studies
Sensitization
Irritation
•	Environmental affacta data
Microbial and algal toxicity
Terrestrial vascular plant toxicity (e g , seed germination
studies, growth inhibition)
Acute and chronic toxicity to animals le g . fish, birds,
mammals, invertebrates)
Other data
•	Risk esaeesmenta
•	Structure/activity relationships
-------
CERTIFICATION
1 certify that to the best of my knowledge and belief
1.	The company named in pan I, section A, subsection 1a of this notice form intends to manufacture or import for a
commercial purpose, other than in small quantities solely for research and development, the substance identified
in part I. section B
2.	All information provided m this notice is complete and truthful as of the dale of submission
3.1 am submitting with this notice sit test data in my possession or control and a description of all other data known
to or reasonably ascertainable by me as required by S 7 20 50 of the Premanuf enure Notification Rule

Confl- ]
deniv
> Signature of authorized official
Date

Signature of egent - (if applicable)
Date

Part I - GENERAL INFORMATION
~ Section A - 8UBMITTER IDENTIFICATION
Confi-
dent!
[ Mark (XI the "Confidential" box next to any subsection you claim as confidential
I.Person Name of authonzed official
submitting
nnrirn
Title

Company

Mailing address (number and street)
Crty, State, ZIP code
b. Agent hf Name of authorized official
applicable)
Title

Company

Mailing address (number and street)
Crty, State, ZIP code
c. 11 you are submitting this notice as part of a /omt submission, mark IX) this box 	t f-]
2. Technical Name
contact
Title

Company
, v -
Mailing address (number and street)
City. State. ZIP code
' Area code
Telephone i
I
Number
If you have had a prenotice communication (PC) concerning this notice and EPA
assigned a PC Number to the notice, enter the number	~

Mark IX)
if none	~ | ]

4. If you have submitted a test-marketing exemption (TME) application for the chemical
substance covered by this notice, enter the TME number assigned by EPA 	~

Mark 1X1
if none 	~ I 1

6. If you have submitted a bona fide request for the chemical substance covered by
this notice, enter the bona tide request number assigned by EPA »

Mark (X)
if none	~ I }

-------
Part 1 - GENERAL INFORMATION - Continued
t Section B — CHEMICAL IDENTITY INFORMATION
Mark IXI the "Confidential" box next to any item you claim as confidential
| Comptota afthar fttm 1 or 2 ai appropriate. CompJrt* all other hami.
If another person will submit chemical identity information for you. mark IXI the box at the right	~ r~]
Identify the name, company, and address of that person tn a continuation sheet
Confi-
dential
1 1 .Cteaa 1 »f 2 rttamlcal aubatancas (for definitions of class 1 and class 2 substances, see the Instructions Manual!
a. Class of substance — Mark IX) | | Class 1 I | Class 2

b. Chemical name (preferably CAS or IUPAC nomenclature)

c. Molecular formula and CAS Registry Number (if known)

d. For a class 1 substance, provide a structural diagram For a class 2 substance - (11 List the immediate precursor substances with their
respective CAS Registry Numbers (2) Describe the nature of the reaction or process 13) Indicate the range of composition and the
typical composition (where appropriate) (4) Provide a representative structural diagram (if possible)

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Part t - GENERAL INFORMATION - Continued
Section B - CHEMICAL IDENTITY INFORMATION - Continued
2. y^niwi (For a definition of polymer, see the Instruction* Manual )	Cor
a. Indicate the lowest number-average molecular weight composition of the polymer you intend to manufacture Indicate the mailmum **""
weight percent of low molecular weight species below 500 and below 1,000 absolute molecular weight of that composition Describe
the methods of measurement or ttie bases for your estimates
| | Mark IX) this box if you attach a continiratton sheet
b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual
information Mark (XI the "Confidential" box next to any item you claim as confidential
(1)	— Provide the chemical name and CAS Registry Number of each monomer or other reactant used in the manufacture of the polymer
(2)	— Mark 
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Part I - GENERAL INFORMATION - Continued
Section B - CHEMICAL IDENTITY INFORMATION - Continued
3. Ifnputttlti
(a) — Identify each impurity that may be reasonably anticipated to be preseni in the chemical substance as manufactured for
commercial purposes Provide the CAS Registry Number if available If there are unidentified impurities, enter "unidentified '
lb) — Eatimate the mailmum weight percent of each impurity If there are unidentified impurities, estimate their total weight percent
Impurity and CAS Registry Number
(a)
Maximum
percent
(b)
Confi-
dential

%


%


%


%


%


%


%

LJ Mark IXI this bo* if you anach a continuation sheet

4. Synonym* - Enter any synonyms for the new chemical substance identified in subsection 1 or 2
f"~| Mark IX) this box if you attach a continuation sheet
Confi-
dential


6. Trad* Idawtlflcatlon — List trade names for tha new chemical substance identified in subsection 1 or 2
| | Mark (XI this box if you attach a continuation aheet


6. Oenarie chamtcal nam* — H you claim chemical identity as confidential, enter the generic chemical name that you developed with EPA
during prenotice communication If you have not developed a genetic name wrth EPA, provide a generic name
that reveals the apecific chemical identity of the new chemical substance to the maximum extent possible
Read the TSCA Chemical Subatance Inventory, Initial Inventory, Volume 1 for guidance on developing generic
names
| | Mark IX) this box if you attach a continuation sheet
7. Byproduct* — Describe any byproducts resulting from the manufacture, processing, use. or disposal of the new chemical substance at
sites you control. Provide the CAS Registry Number if available
Byproduct
(11
CAS Registry Number
12)
Confi-
dential









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k
Parti - GENERAL INFORMATION - Continued
8«ctlon C - PRODUCTION, IMPORT, AND USE INFORMATION
Mark tX) the "Confidential" box next to any item you claim as confidential
1 . Production volume - Estimate the maximum production volume during the first 12 months of production Alto estimate the
maximum production volume for any consecutive 12-month period during the first three years of production
Con ft-
Maximum first 12-month production (kg/yr)
Maximum 12-month production Ikg'yi)



2. Um WwiiuHod — You muit make feparata confidentiality claims tor tfm description of the category of use. the percent of production volume devoted to each
category. ttve formulation of the new tubstanct, and other use information Mark (X)the "Confidential" box next to any item you claim at confidential
•.(II — Deecnbe each intended category of use of the new chemical substance by function and application
(21 — Mark (XI this column if entry m column ill is confidential
(31 — Estimate the percent o1 total production for the first three years devoted to each category of use
<41 — Mark (XI ttin column if entry in column (31 w confidential
(51 — Estimate the percent of the new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured
for commercial purposes at sites under your control associated wrtfi each category ot use
(61 — Mark (X) this column if entry in column (51 is confidential
(7) — Mark (X) whether the use is srte-limrted, industrial, commercial, or consumer Mark more than one column if appropriate
(81 — Mark (X) this column if entry(iesl in column (7) is (are! confidential
Read the Inatructions Manual for examples
Category of use
(II
Confi-
dential
12)
Production
(percent)
(31
Confi-
dential
(41
Formulation
(percent)
(5)
Confi-
dential
(6)
Mark (XI appropriate eolumnltl
	 (7)
Site-
limited
Indus
trill
Com
mercul
Con
mmer
Confi-
dential
181
%
%
%
%
%
%
f- Mark IX) this box if you attach a continuation sheet
b. Generic
use
description
If you claim any category of use description in subsection 2a at confidential, enter a (generic descnption of that
category Read the Inatructiona Manual for examples of generic use descriptions
~
Mark (X) this bo* if you attach a continuation sheet
3. Hazard Information — Include in the notice a cot- nr roinnnn^W^i Vt* n-im* w	.i
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APPENDIX B
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET
To assist EPA's review of physical and chemical properties data, please complete the following
woer 1 | Mark tXi
Ibl | ic) 1 id>
1 Vapor pressure
ffl Tpmnpraiure w

1
^ torr

2 Dentiiy/relBttve density

1 B/e3

3. Solubility
0 C
1® Tpmp^ratuf* .
Rnlwont

1
1
t

4 Melting temperature

! -c

6 Boilirig'sublimation temperature


•c j
6 Spectra I
i

7 Dissociation constant

i

i
8 Panicle sue distribution 1
!
9. Octanof/waier partition coefficient

1
l
1

10 Henry's Law constant



11 Volatilization from water



12 Volatilization from soit

1
i i
13 PH


i
14 Flammabiiity

i

IS Expiodstoilitv




16 Adsorpuon/desorption




17 Other — Speci/v




IB




19




20




21




22




Ps?e 13
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2 During notice review
The notice review period begins upon receipt of the
nonce by the OTS Document Control Officer The
Inventory is searched to ensure that the substance 'or
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 is not sublet to pre
manufacture notification, and therefore you are free
10 begin manufacture immediately If the substance
is not on the Inventory, a Notice Manager is assigned
to coordinate the review of the notice and to be your
official contact with the Agency throughout the
review period The Notice Manager will acknowledge
receipt of your notice and review it to see that you
have complied with EPA's information requirements
The Notice Manager will contact you if your submis
ston is incomplete and will identify the information
required to complete your submission During the
review period, the Notice Manager may contact you
for clarification of information you have provided in
the notice
EPA will notify you before the review period expires
if it will extend the review period under TSCA
section 5(c) or if it is considering regulatory action
on the new substance under TSCA section 5(e)
or 5e the
need to make any notification of risk to heaMh under
5 720.36 of rhe Rule If you manufacture under a
test-marketing exemption under TSCA, you must
retain documentation of information in the applicat-on
and documentation of your compliance with any restnc
tions 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 11
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II. SUPPLEMENTARY INFORMATION
A Who Mutt Submit A Premanufacture Notice
II you intend to manufacture or import a new chemical
substance for a commercial purpose, you must submit a
premanufacture notice to EPA You must submrt a
notice if you intend to import a new substance in bulk
form or as pan of a mixture, bui not if you intend to
import the substance only as part of an article
Premanufacture notices for imported new chemical sub
stances should be submitted by the principal importer
"Principal importer" is defined in i 720 3IjI of the Pre
manufacture Notification Rule
Generally, when you contracl with another person 10
manufacture a new chemical substance, that person mus;
submit the notice However, if you request another
person to manufacture a new chemical substance, and if
you specify the identity and total amount of the sub-
stance to be manufactured and the basic technology
and controls under which the substance will be pro
dueed. and if that person manufactures the sutKU"ce
exclusively for you. you must submit the notice EPA
recognizes that in this and similar instances, the other
manufacturer may have information useful to the
Agency's review of the new chemical Therefore, EPA
strongly encourages joint submission in these situations
(see section E 2 below)
For additional information on who must submit a
notice, see S 720 22 of the Rule
B.	Subttancet Which Must Be Reported
1 General
Vou are responsible for determining whether a sub
stance you intend to manufacture or import is a
"new" chemical substance as defined by the Act
and S 720 3 of the Rule You must submit a pre
manufacture notice for any new chefnficarsufcstance
which is not on the TSCA Inventory or otherwise
excluded from notification, as discussed beloi.
2. Bona fide request for a TSCA Inventory search
The specific identities of some chemical substances
on the Inventory are 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 If a substance you
intend to manufacture or import is 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 if you can
demonstrate a bona fide intent to manufacture or
import the substance Section 720 25 of the Rule
describes the procedure for demonstrating such a
bona fide intent
After conducting its search, EPA will tell you if the
substance is included on the Inventory and therefore
not subject to premanufacture notification or if you
must submit a premanufacture notice
C.	Substances Excluded from Notification
1. General
Section 720.30 of the Rule excludes certain sub
stances from premanufacture notification These
include mixtures, substances manufactured solely for
use as pesticides, food, food additives, drugs, or
cosmetics, tobacco and tobacco products, nuclear
source materials, firearms and ammunition, impuri
ties, byproducts which have no commercial use.
nonisolated intermediates, new chemical substances
manufactured solely for export, and substances as
described m J720 30(h>(3-7)
2	Research and development exemption
You do not have to submit a notice for a new sub
stance manufactured or imported m small quantities
solely for research and development as specified m
S 720 36 of the Rule "Small quantities" are ihose
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 11 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 premanufacture notice 90 days
before you intend to manufacture the substance for
a purpose other than research and development
To qualify for the exemption, your research and
development activities must be conducted under the
supervision of a technically qualified individual You
must evaluate available information to determine
whether there is reason to believe there is any tisk to
heallh associated with the new chemical substance
You must notify all persons engaged in experimen
taiion, research, or analysis of the new chemical
substance of any risk to health based on this evalua
ticri and keep records of the information you used to
determine the need to make any notification You
also must determine whether the substance is subject
to any rule or order proposed or promulgated
under section 4, 5, or 6 or notice requirement of
section 8(e) of TSCA The Rule defines "technically
qualified individual" and states the otnei require
ments for this exemption
3	Ten-marketing exemptions
You may apply for an exemption from premanu
facture notification if you plan to manufacture or
import a new chemical substance for test-marketing
Test-marketing is the distribution of a limited amount
of a chemical substance, or of a mixture or article
containing the chemical substance, to potential
customers to explore market performance before
general distribution
To approve a test-marketing exemption application,
the Agency must make an affirmative finding that
the new chemical substance will not present an
unreasonable risk to health or the environment during
the test marketing activities Section 720 38 of the
Rule identifies the type of information you should
submit with a test-marketing exemption application
EPA must approve or deny the application within
45 days tf you do not provide sufficient information
for EPA to make its determination withm 45 days,
the Agency will deny the request
You should send applications for test-marketing
exemptions to the OTS Document Control Officer
fTS-793)
Page 9
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2 Occupational Exposure
S«ction B — Industrial Sites Controlled by Othen
Column (1) - Describe each specific activity in the opera
tion duung which workers may tie exposed to the new
chemical substance Such activities may include charging
Teactor vessels, sampling for quality control, transferring
materials from one work area to another, drumming
bulk loading, changing filters, and cleaning equipment
Activities must be described even if workers wear pro
tective equipmeni IMatenal Safety Oata Sheets indicating
recommended protective equipment should be submitted as
part of Hazard Information in pari I, section C,
subsection 3 o1 the notice form 1
Column (2) - Indicale the physical form of ihe new
substance al the time of exposure, e g , solid (crystals,
granules, powder, dust), liquid (solution, paste, slurry,
emulsion, mist spray), gas (vapor, fume), even if workers
wear protective equipment
Column (3) — Estimate the maximum number of workers
involved in each specific activity, based on the estimated
maximum 12-month production volume
Column (4J — Enter the maximum duration that any one
worker wli engage in the activity in hours/day, eg,
8 hours/day
Column (51 - Enter the maximum duration that any one
worker will engage in the activity in days/year, e g , 200
days/year, based or the estimated maximum production
volume
Note that you must make separate confidentiality claims
for the description of worker aciivity, physical form of the
new substance, number of workers exposed, ai>d duration
of exposure
3. Environment*] Release and Disposal
Column (2) — Estimate the amount of the new chemical (in
kg/day for continuous operations or kg/batch tor batch
operations) that will be released from the release point
before entering control technology Base your estimate on
the estimated maximum 12-month production volume
Column (3) — Enter the media (air, land, water) into which
the re/ease stream discha-ges (whether or not control
technology « used)
Column (4) - For releases to the air and water, describe the
type of technology used to control the release of the new
chemical Examples of control technologies include carbon
filter, scrubber, and biological treatment (primary,
secondary, etc ) Give as complete a description as possible
Enter "none" if no control technology is used and the
substance is released directly to the environment
For disposal on land, describe the landfill site constructior
(including liners) and handling procedures Describe 'land
fill containers
Column (5) - Mark (XI the appropriate box and/or specify
other destinations of water releases
Note that you must make separate confidentiality claims
for the release number and amount of new chemical sub
stance released and other release arid disposal information
Complete a separate section B for each rypie of processing or
use operation associated witn each category of use (specified
in part I, section C. subsection 2aI at industrial sites you do
not control
Describe each typical processing or use operation to the
maximum extent possible from information Known to or
reasonably ascertainable by you Identify the unit operation
steps that may occur during the operation Estimate the
number of sites at which the operation is likely to occur
Identify situations in which potential exposure to and
environmental release of the new chemical substance may
occur Estimate the percent formulation of the new chemical
substance in products manufactured for commercial purposes
in the operation or as used in trie operation and indicate its
physical form Estimate the maximum number of workers
exposed to the new substance during the operation, and
duration of potential exposure
Provide an estimate of the maximum amount of new chemical
substance in kilograms per year thai may be released to the
workplace, air, water, or land under typical operating condi
tions, if possible Describe any control technology which
may be used to limit worker exposure and environmental
release Identify byproducts which may result from the
operation Describe destinations of potential releases to the
environment
For example, for a paint spraying operation at an automobile
plant, you might provide the lollowing information 1 you
know or can reasonably ascertain n
Paint spraying of automobiles will take place m ventilated
spiay booths, which have filteis or water curtains to collect
overspray (typically 20-50 percent) About 100-500
workers will be involved for 8 hours/day, 240 days/year
in spray operations involving the new chemical substance
The new substance usually will be in a 6—10 percent formu
lation in the paint Overspray will be lanrlfilled, either as
" part of the filter or as sludge from the water curtain
Solvent will be captured in an absorber and incinerated
Releases of new chemical substance to water and air are
expected to be less than 1,000 kg/yr Worker exposure is
typically limited by the use of respirators that are approved
for the solvent and paint particulate by NIOSH
Frequently, you may also be able to provide other information
on exposure and release of the new substance or products con
taming the new substance during the operation
Part 111 - LIST OF ATTACHMENTS
Attach any continuation sheets for sections of the form, test
data and other data (including physical/chemical property and
structure activity information), and optional information
after the last page of the form Clearly identify the attach
ment and the section to which it 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 (XI the "Confidential" box next to any attachment
name you claim as confidential Read part I. section C 1 on
page 2 of (his manual for guidance on how to claim any
informatior 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
as confidential
Column (1) - For each release point indicated in the
process description (part II, section A, subsecuor.	1-	
the riotjce form, enter the corresponding number
Pbijc 7
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•	a libei reactive dye for nylon carpeting and
upholsiery
•	an antioxidant in fuel oils and lubricant
12)	Estimate the percent of the total production volume
that you anticipate will be manufactured for each
category of use
13)	Estimate the weight percent of the new chemical
substance that will be contained m anv formulated
mixture, suspension, emulnon, solution, or gel
associated with each category of use as manu
factured for commercial purposes at sites under
your control Where the substance is distributed
from your site neat, enter N/A (for not applicable)
For example
Category of Use
1	Cross linking
ageni (or
epoxv ivoe
costing* lor
meiai surfaces
2	Surlactant er reactive
Ove lor nylon
carpeting and
upholsierv
5	Colorant fo-
paper and
other celluioncs
6	Flam* reiarO
• PI lor cotton
aoparEl
Formo'atecf
Product as
Manufactured
none distributed
neat
sprat automobiit
wa* (susoer>sion)
lubricant tsolulion)
powdered dye
lumiurei
Percent oi
New Cfiernicai
Substance
N/A
85
colorant (solution)	55
none distributed
neat
rv.'A
(41 Mark (X) to indicate if the category of use is site
limited Also mark (X) to indicate whether the
substance is intended for industrial, commercial,
and/or consumer use, as defined below
Site-limited - The substance will be used only on
the contiguous property unit where it is manufac
tured and not intentionally distributed outside that
site 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-site to produce a pesticide
Induitrial - 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
product! containing the substance will be used by
a commercial enterprise providing a consumer
service, e g , use by commercial dry cleaning estab
lishmenti, use by painting contractors, or use by
roofers in commercial building construction
Consumer — The new chemical substance or
products containing the substanoe will be used by
private individuals in or around a residence, or
during recreation, oi for any other personal use or
enioymeni e g automotive polish, dyed wearing
apparel, household cleaners, etc
Mark mere than one box, if approoTiaie For example,
a surfactant in an automobile wax may have a consumer
use in liquid wax, a commercial use in auto washes, and
an industrial use by automobile manufacturers
Note that you make separate confidentiality claims
for the description of the category of use. the percent of
production devoted to each category, the formulation of
the new substance, and other 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 opnonal information
b 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
Tt\e generic us( shouSd reveal the intended category of
use to the maximum extern possible For example, the
specific use of a new substance as an antioxidant m a
lubricant could be described generically as a lubricant
additive, a fiber reacrive dye for nylon carpeting could
be described genetically as a dye for fibers 11 such a
generic description does not provide a sufficient indica
lion of potential exposure the description can also
describe the degree of containment of the new chemical
substance, as shown in the list below
Degree of Containment
(a) destructive use
lb) contained use
(e g . fuels fuel additives,
chemical intermediates)
!e g . catalysts used 
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The nature of the reaction must be described as
specifically as possible (e g . acetylatior,, alkaline
hydrolysis, diazotization) For substances that have
been produced without chemical reaction (e 9 by
chemical extraction from a natural source) specify
the source the proOuction process, and the nature
of the product
(31 If you intend to manufacture a Class 2 chemical
substance within a limited range of possible com
positions report the range For example, a
manufacturer filing a notice for chlorinated
naphthalene might specify a compositional range of
20—40 percent chlorine by weight In determining
the range, you may have to consider the reaction
conditions, the catalyst, 01 the purification process
that may be used to produce the substance and
other factors You should provide the range of
composition m weight percent for each specific
component or class of components that you intend
to manufacture for commercial purposes Indicate
the typical composition or any actual values for
samples
(41 Provide a partial or incomplete structural diagram
if possible The diagram should indicate the char
actenstic structure or variable compositional
elements of the substance
2. Polymers
a Indicate the lowest number average molecular weight of
any composition of the polymer you intend to manu
facture Identify the method you used to make this
determination (e g , vapor pressure osmometry or other
colligative property determinations, gel permeation
chromatography, light scattering, or various correlative
techniques] If you have not determined number
average molecular weight by analytical methods, briefly
explain the basis for your estimate Indicate the
maximum weight percent of low molecular weight
species below 500 and below 1,000 absolute molecular
weight Include the weight of oligomeric reaction
products (including moiecules tOrmeiJ war ffrrTrar
polymer molecules) in your determination bu* do not
include the weight of residual monomers or other
reactants Anach test data supporting your estimate
If you do not have actual test data, provide an estimate
and describe the basis for the estimate
b (1) Provide the chemical name and CAS Registry
Number of each reactant used in the manufacture
of the polymer, including those used at 2 weight
percent or less Reactants include monomers,
catalysts, free radical initiators, and cross-linking,
chain transfer, and other reactive agents that are
used intentionally to become chemically a part of
the polymer composition If a prepolymer is used
in the manufacture of the polymer, list the pre
polymer in terms of its cpmponent reactants
Identify by bracketing or another method that the
monomers are components of a prepolymer
(2) For each reactant (including monomers!, indicate its
typical weight percent in the polymer The weight
percent of a reactant is the weight of the reactant
charged to the reactor divided by the weight of the
polymeric chemical manufactured (times 100)
Thus, the weight percent of reactant A of a polymer
manufactured from reactants A, B, and C is the
weight of A charged to the reactor divided by
the dry weight of the polymer A-B-C (times 100)
If you use a prepolymer in the manufacture of the
polymer, you must determine the weignt percent of
its component reactants For example the weight
percent of E used in the manufacture of a polymer
from reactants A, B, and C and prepolymer O-E
is the total weight ol monomer E in the prepoly
mer D-E used divided by the weight of the polymer
A-B-C-D-E manufactured (times 100} You
must provide the identity and typical weight
percent of each monomer and other reactant used m
the manufacture of the polymer regardless of the
weight percent at which it is 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
(3)	Reactants used at greater than 2 weight percent in
the manufacture of the polymer are included as
part of the description of the polymer listed 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 1he polymer
Mark (X| the identity column tf you want a
reactant present at less than 2 weight percent 10
be included in the description of the polymer which
is added to the Inventory
(4)	Indicate the maximum weight percent of each
reactant that may be present as a residual (unre
acted material) m the polymer as manufactured for
commercial purposes
Note that you must make separate 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 the 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 unit*, 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
HO-R-O-(C-R'-C-O-R-O) -H
n
3
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I. INSTRUCTIONS FOR COMPLETING THE
PREMANUFACTURE NOTICE FORM
A General Instructions
Complete the premanufacture notice form using a type
writer or by printing legibly in black ink All information
mult be in English Provide ait 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 ascertainable! You may
attach continuation sheen to any subsection or item on
the form Mark (XI 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 tn 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 i 720 50(d) of the Rule Importers must
submit nonexposure data such as data on health effects
(including epidemiological studies I, ecological effects,
physical and chemical properties, or environmental fate
characteristics and exposure information on sites under
their control within the United Stales
Vou may photocopy the notice form, sections of the form,
or this manual as frequently as you need
Send your completed notice to the Office of Toxic Sub
nances JOTS) Document Control Officer fTS—793). whose
address Bppears on page one of the form
8 Tert Data and Other Data
Vou ate also required to provide test data on the health and
environmental effects of the new chemical substance in
your possession or control, and B description of any other
health and environmental effects data on the substance
known to or reasonably ascertainable by you Standard
literature citations may be submitted for data in the open
scientific literature Complete test data, not summaries of
data, must be submitted if'they do nofappear in the open
literature Examples of the types of test data you must
submit are provided in Appendix A of this manual For
additional information on health and safety stwfces and
on submitting test data, see U 720 3 and 720 50 of the
Premanufacture Notification Rule Attach test data to the
notice form and reference it by page number in Part III,
List of Attachments
You are not required to submit any data previously sub
muted to EPA with no claims of confidentiality if you
identify the office or person (o 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 resubmit the data with
the notice and any claim of confidentiality under 1720.80
of the Rule You also are not required to submit data
related solely to product efficacy This exoeption does not
apply to information required in the notice, test data, or
other data
C. Confidentiality
1. Assarting daims
You may assert a claim of confidentiality for any infor-
mation submitted to EPA To assert confidentiality
claims for specific information on the form (e g ,
submitter identity chemical ideniity. or use mforma
tionl mark (X) in the "Confidential" box on the form
located 10 the ri^it of the information Also mark (XI
the boxlesl on page one of the form to indicate the type
of information you have claimed as confidential in the
form Marking these boxes will provide a quick
reference for EPA to determine what information is
confidential, thus aiding proper treatment of confi
dennal business information
To assert confidentiality claims fot information in
attachments to the form, provide a complete copy of
the attachment that clearly indicates (e g . by circling
or bracketing) the information you wish to claim as
confidential Bracket only the specific information you
claim as confidential For example, if you submit a
study which contains a physical or chemical property,
and it is only that property which you wish to claim as
confidential, bracket only that property Do not limply
stamp "Confidential" on the page which contains that
property
If you claim the identity of the new chemical substance
or its category of use as confidential, you must provide a
generic description of this information, as indicated in
the appropriate sections of the form Guidance on
developing generic names is given in the instructions for
those sections of this Manual
To ensure that no confidential information is disclosed
to the public, you must submit a second copy of the
notice form, including attachments, which does not
contain confidential information Thu "sanitized"
version wilJ be placed in the public file It must contain
aJI 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
2 Substantiating claims
You are not required to provide substantiation of any
confidentiality claim wtien you submit your notice
However, you must substantiate your claim of confi
dentiality for chemical identity at the time you submit
a notice of commencement of manufacture, if you want
EPA to maintain your confidentiality claim after you
begin manufacture To substantiate that claim.'you
must provide EPA with detailed answers to the questions
which appear 
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f/EPA
uniiedstBies	INSTRUCTIONS MANUAL FOR
Protection Agenev
E" O ^"'8	PREMANUFACTURE NOTIFICATION
OF NEW CHEMICAL SUBSTANCES
EPA-7710-25(IU5 23 83)	OFFICE OF TOXIC SUBSTANCES	Washington 0 C 20460
Trie U S Environmental Protection Agency IEPA) h»s prepared this manual toasstsi you in submitting
a prtman jiacuie notice under tecvofi 5 of The Tome Subttincw Contro. Act (TSCAI Tne manual
provides instructions on submitting a premanufacture nonce, asserting confideritia ily claims, completing
the notice form and submitting test data and optional information Before consulting this manual, you
should read the Premanufacture Notice Requirements and Review Procedures (Premanufacture Notifi
canon Rule) (40CFR {7201
TABLE OF CONTENTS
I	INSTRUCTIONS FOR COMPLETING THE PREMANUFACTURE NOTICE FOHM	Page
A. General Instructions
B Test Data and Other Oata
C Confidentiality
0 Certification
E Completing the Parts of the Notice Form
Pan I General information	?
Section A - Submitter Identification	2
Section B - Chemical Identity Information	2
Section C - Production, Import, ana Use Information	4
Part II Human exposure and environmental release	6
Section A - Industrial Sites Controlled by the Submmei	6
Section 6 - Industrial Sites Controlled by Others	7
Part III Lilt of Attachmenti	7
F Optional Information	8
II	SUPPLEMENTARY INFORMATION	9
A Who Must Submit a Premanufacture Notice	9
B Substances Which Must be Reported	9
1	General	9
2	Bona fide request for a TSCA Inventory search	9
C Substances Excluded from Notification	9
1	General	9
2	Research and development exemption	9
3. Test marketing exemptions	9
4 Section 5(h)(4) exemptions	10
0 When to Submit a Notice	10
E Consolidated Notices	10
F. Submission of Information by Others	10
1	Submission by an agent	10
2	Joint submissions	10
3. Other submissions	10
G Consultation wuh EPA Concerning the Premanufacture Notice	10
1, Before notice submission	10
2 During notice review	11
H Notice of Commencement of Manufacture	11
I. Recordkeeping	11
Appendix A - Examples of Test Data
Appendix B - Physical and Chemical Properties Worksheet
12
13
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| Part II -
HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

^ Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER
C«mpl«1f Motion A (or *ach typ« of manufacture, pracMiIng, or um operation Involving tho now chamlcal
substance at Industrial alto* you control.
Mark IXI the "Confidential" box next to any item you claim bs confidential
1. Operation description

Confi-
a. Identity— Enter the identity of the site at which the operation will occur
dential
Name

Site address (number and street)

City. County State. ZIP code

If the same operation will occur at more than one site, enter the number of sites 	~ 1
Identify the additional sites on a continuation sheet 1
1

~ Mar* IXI this box if you attach a continuation sheet

b. Type -
Mark IX)
ED Manufacturing ED Processing ED Use

c. Amount and Duration - Complete 1 or 2 as appropriate

1 Batch
Maximum kgfbatch ' Hours/batch I Batches/year
l l
I I

2 Continuous
Maximum kg/day 'Hours'day ' Days'year
l I
I i

d. Process description
(1)	Diagram the maior unit operation steps and chemical conversions
(2)	Provide the identity, the approximate weight (by kgJday or kg/batch), end entry point of all feedstocks (including reactants
solvents, and catalysts)
(3)	Identify by number the points of release to the environment of the new chemical substance


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k
Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
8«ctlon A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER - Continuad
2. Occupational Exposure — You must make separate confidentiality claims for the description of worker activity, physical form of the new chemica
substance, number of workers exposed, and duration of activity Mark (X) the "Confidential" box next to any item you claim as confidential
(11 — Oescnbe the activities in which worker! may be exposed to the new chemical substance Include activities in which workers wear protective equipment.
(21 — Mark (XI this column if entry in column (11 is confidential
(31 — Indicate the physical form(s) of the new chemical substance at the time of exposure
(41 — Mark (XI this column if entry in column (31 is confidential
(51 — Estimate the maximum number of workers involved m each activity
(6) — Mark IX) this column if entry in column (5) is confidential
(71 and (6) — Estimate the maximum duration of the activity for any worker in hours per day and days per year
(91 — Mark (XI this column if entries In columns (7) and (B) are confidential
Worker activity
111
Confi-
dential
(21
Physical
form(s)
(31
Confi-
dential
(4)
Maximum
number
(51
Confi-
dential
(6)
Maximum duration
Hrs/day
(71
Oays/yr
(8)
Cor
dantlal
(9i
~
Mark (XJ this box if you attach a continuation sheet
3. Environmental Ret**** and Disposal - You must make separate confidentiality claims for the release number and the amount of the new chemic
substance released and other release and disposal information Mark (X) the "Confidential'' box next to each item you claim as confidential
(1) — Enter the number of each release point identified in the process descnption, pert II. section A, subsection 1d(3)
(21 — Estimate the amount of the new chemical substance released directly to the environment or into control technology (in kg/day or kg/batch)
(3)	— Mark (X) this column if entries in columns (11 and (2) are confidential
(4)	— Identify the media (air. land, or water) to which the new substence will be released from that release point
(51 — Describe control technology, rf any, that will be used to limit the release of the new substance to the environment For
releases disposed of on land, characterize the disposal method
(6)	— Mark (X) this column if entries in columns (41 and (51 are confidential
(7)	— Identify the destinattonls) of releases to water.
Release
Number
(1)
Amount of new substance
released
(2)
Confi-
dential
13)
Media of
release
(41
Control technology
(51
Con1
dent
16)























-












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Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS
CompUf Motion B for each typa of proeoMtng or um operation Involving the new chemical »ubrt«nc» at aftes you do not control
To ctam information in this section at confidential, circle or bracket the aparflTr information that you claim as confidential
Operation description
Describe the typical processing or use oper at/on Identify rhe unit operation steps which may occur during the operation Estimate
the number of sites at which the operation ishJrWy to occur Identify situations in which worker exposure to and/or environmental
release of the new chemical substance may occiu Estimate the percent of new chemical substance as formulated in products
manufactured for commercial purposes in the operation or as used the operation Estimate the number of workers exposed and
the duration of exposure Identify controls which limit worker exposure and environmental release if typically used Identify
byproducts which may result from the operation
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Part III - LIST OF ATTACHMENTS
Attach continuation sheets (or sections of the form and test data and other data (including physical/chemical properties and
structure/activity information), and optional information after this page Clearly identify the attachment and Ihe section of the form to
which rt relates, if appropriate Number consecutively the pages of the attachments In the column below, enter the inclusive page
numbers of each attachment
Mark (XI the "Confidential" box next to any attachment mim you claim as confidential Read the liwUucUone Manual for
guidance on how to claim any information in an attachment as confidential You must include with the sanitited copy of the notice
form a sanitized version of any attachment in which you claim information as confidential ;
Attachment name
Attachment
page numberlsl
Confi-
dential














I











i













































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APPENDIX D
GLOVE TESTING GUIDELINES
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D C 20460
PESTICIDES AND TOXIC 3UBSTA
MEMORANDUM
SUBJECT: Glove Requirements for Section 5(e) Orders
FROM: A. E. Conroy II, Director
Office of Compliance Monitoring
TO:
Add res s es
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 (PHN) 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
"Document ati on 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
the glove requirements and be able to document pertinent
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.
These section 5(e) inspection procedures are effective
immediately. If you have any questions, please contact
Michael Kackett of my staff at 382-7861 .
Att a ch ment
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^pendix &
Section 5(e) inspect! on P roc edu r e
Documentation for Glove ftequirements in~5(e) Orders
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 gl ove maten al s .
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 .love 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., chemicals in the
same chemical class evaluated by glove manufacturers or other
experts). The record documenting glove selection should include:
1)	an analysis of the 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 mat e ri a 1 ( s )
selected and the reasons for concluding that the
mat eri a 1 ( s ) will provide protection during the full
penod 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 any differences
between chemical substances as tested and the substance
as expected to be encountered by workers (e.g.,
test of pure compound but contact with 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. l)CM will forward information
on glove selection and use to UTS for their information and review.
May lytfb U p da
A-2 3
Inspection Manual
Four. Section 5 Manual
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APPENDIX E
EPA HQ § 5 INSPECTION GUIDELINES
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APPENDIX B
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET	|
To assist EP^ s review of physical and chempcal properties data please complete ihe following
wa^sneet for oata you provide ana include >t m the notice icent~ *v "he property measupec the cage o*
the notice on which the propenv appeals trie vaiue o* the property t*e units in which ?ne prooertY is
measureo las necessa»yl, and whether ot not the property »s claimeo as conhoentiai Vou are not reQu^ed
to supmn this worksheet however EPA recommends that vou do so as it will simplify review ana ensure
tna: confidential miormation is properiy protectee *ou snou'd Supmit;nworksheet as a supplement \o
vour submission of test data This worksheet is not a substitute for submission of test data
i
P'ODflrtv ! Mark tx ,f
provioeo
(si
nPJ&. v"ue o'e-'a
numpei
Vlj'i *
ItJl I c' -
1 vaoor pressure ;
(ni T»mnpratnrp ^ !

2 Demnv refstive densnv |
9C3
3 Solubility 1
0 C
(Sf 1 emoe'dtwe —.
^nlvpnl j
i I
4 Meftmg temperature <
¦
5 Bothng sublimation temperatu'e 1
!
6 Specva 1
i
7 Oissociatior constani '
i |
8 Psmcie s»*« disinbution 1
( i
9 Octanoi *ater panrtion coefficient I
i
10 Henry s Law constant |
¦
11 Volatilization Irom wate' '
i
12 Volatilisation from »o>< j
¦
13 pN

I |
14 Fl^mmabililv 1
I !
IB E>piodabiiitv

! i
16 Aosorpnon/desorplton

I

17 Other — Specrfv


i
i
18

i
i i
19




I
20 |



I
" I
{
i

!
i
1

P»9* 13
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2 During oouc* review
The notice review penod Degms upon receipt of the
notice by the OTS Document Control Officer The
Inventory is searched to ensure that the substance tor
whicn 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 suostance is not subiect to pre
manufacture notification and therefore you are free
to begin manufacture immediately If the substance
is not on tne Inventory a Notice Manager is assigned
to coordinate the review o< the notice and to be your
official contact with the Agency throughout the
review period The Notice Manager will acknowledge
receipt of your notice and review it to see that you
have complied with EPA s information requirements
The Notice Manager will contact you if your submis
jion is incomplete and will identify the information
required to complete your submission During the
review period, the Notice Manager may contact you
for clarification of information you have provided in
the notice
EPA will notify you before the review period expires
if it will extend the review period under TSCA
section 5(c) or if it is considering regulatory action
on the new substance under TSCA section 5(e)
or 5(f I
H Notice of Commencement of Manufacture
It EPA nas not taken any action to regulate the new
chemical substance during the review period you may
Degin manufacturing the new chemical substance upon
expiration of the review period EPA requires that
you notify the Agency by lerter on the day that you
commence manufacture or import of the substance
for commercial purposes so that the substance may be
added to the Inventory Your notice of commencement
of manufacture should be sent to the OTS Document
Control Officer (TS—793) In your lerter you must
provide the identi'y of the substance its premanufacture
notice number, and the date when manufacture or
import began You must also provide a generic chemical
name and substantiate a confidentiality claim for
chemical identity in your letter if you want EPA to
mamum the clairr vol t)egirt mani-fac*-r? y
impon See part I section A of this Manual !or .n'or
mail on on developing generic names ana suDsiai- tiaiir 3
confidentiality claims
I Recordkeeping
Section 720 78 of the Premanufacture Notification Rule
reauires 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 (21 other
data, as definea in S 720 50 (bi of the Rule in your
possession or control (3) production volume for the
first three years of production or import and docu
mentation of production volume, and (4) date of
commencement of manufacture, ana documentation
of this date For examoie, if you performed a market
analysis to estimate maximum production volume as
repprted on the notice form, you would retain this
analysis, even though production volume and market
sharp may change If you have performed a chemical
analysis to determine what byproducts may result from
operations at sites you control you would retain that
analyse You a^e not required to develop information
solely for recordkeeping purposes, but only to retain
information you have obtained or developed m the
course of completing your submission
If you manufacture a new chemical substance under the
exemption for substances manufacturea toieiy for
research and development, you must retain documents
tion of compliance with the exemption for five years
from the final date of manufacture or import under the
exemption The recorcs vGj must maintain include
copies of the information you used to determine the
need to make any notification of rrjk to health under
S 720 36 of the Rule	manufacture under a
test marketing exemr	¦<' TSCA, you must
retain documentation c - - m the appliC3"on
and documentation of your compliance witn any resiric
tions 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
P»?e 11
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II. SUPPLEMENTARY INFORMATION
A Who Must Submit A Premanufacture Notice
H you intend to manufacture or imoort J new chemical
substance for a comr^e'c.a* Durpose vou ^'jS*	a
oremanutacture nonce to EPA You must submrt a
notice if you imend to >mpor a new suOStar>ce in bulk
form or as can of a mixture Bui noi if you interna to
import the substance only as pan of an article
Premanufacture notices for imported new chemical sue
stances should be submitted bv the ormooal imoorter
'Principal imoorter" is defined m I 720 31zI of tne Pre
manufacture Notification Rule
Generally, when you contract witf* another person to
mar jfacture a new chemical substance, that person mus'.
s«w 'l the notice However, if you request another
pe'son to manufacture i hew chemical substance and if
you specify the identity and total amount of the sub-
stance to be manufactured and the basic technology
and controls under which the substance will be pro
duced. and if that person manufactures the jubilance
exclusively tor you, you must submit the nonce EPA
recognizes that in this and similar instances the other
manufacturer may nave information useful to the
Agency's review of the new chemical Therefore EPA
strongly encourages icint submission in these situations
(tee section E 2 belowl
For additionaf information on who must submit a
notice, see i 720 22 of the Rule
B Subflineei Which Must Se Reported
1 General
You are responsible for determining Wiethe' a sub
stance you intend to manufacture or import is a
"new" chemical substance as defined by the Act
and S 720 3 of the Rule You must submit a pre
manufacture notice for any new chtrfficarsuUstance
which is not on the TSCA Inventory or otherwise
excluded from notification, as d.scussed belo.
2. Bona fid* request for a TSCA Inventory search
The specific identities of some chemical substance3
on the Inventory are confidential and therefore do
not appear on the Inventory available to the public
Such substances are described by generic names m the
Appendix to the Inventory If a substance you
intend to manufacture of import is not on the
publuhed Inventory bet 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 if you on
demonstrate a bona fide intent to manufacture or
imoort the substance Section 720 26 of the Rule
describes the procedure for demonstrating such a
bona fide intent
After conducting its search, EPA will tell you if the
substance is included on the Inventory and therefore
not sublet to premanufacture notification or if you
must submit a premanufacture notice
C. Subrtances Excluded from Notification
1. General
Section 720 30 of the Rule excludes certain sub-
stances from premanufacture notification These
include mixtures, substances manufactured solely for
use as pesticides food food add'tues. drugs or
cosmetics tobacco ana tooacco products nuciea'
source materials firearms and ammunition unour,
ties byproajcu which ha»e no cammerc al use
nonisolated intermediates new chemical suDitar.ces
manufacturer sololy fo-_ exoort anc substances as
described in 1720 30lh)(3-7l
2	Research and development exemption
You do not have to submit a notice for a new suo
stance manufactured or imported m small quantities
solely for researcn and development as specified ir.
< 720 36 o' the Rule "Small quantities ' are those
not greater than reasonably necessary for researc-
and development purposes The quantity wnicn 13
reasonable may vary depending on the segments of
the industry or the nature of the research and
development activities It is your responsibility to
determine what is reasonable in your situation You
do not have to apply for this exemption Howeve'
you must submit a premanufacture notice 90 days
before you intend to manufacture the substance fo'
a purpose other than research and development
To qualify for the exemption, your research and
development activities must be conducted under the
supervision of a technically qualified individual You
must evaluate available information to determine
whether there is reason to believe there n any njk to
health associated with the new chemical substance
You must notify all persons engaged in expenmen
tation. research, or analysis of the new chemical
substance of any nsk to health based on this evaiua
tion and keep records of the information you used to
determine the need to make any notification You
also must determine whether the substance is subiect
to any rule or order proposed or promulgated
"under section 4, 5, or 6 or notice requirement of
section 8(el of TSCA The Rule defines "technically
qua'i'ied individual" and states the otner require
ments for this exemption
3	Tert-markeong exemptions
You may apoly for an exemption from oremanu
facture notification if you plan to manufacture or
import a new chemical substance for test-marketing
Test marketing is the distribution of a limited amount
of a chemical substance, or of a mixture or art.cie
containing the chemical substance, to potential
customers to explore market performance before
general distribution
To approve a test marketing exemption application
the Agency must make an affirmative finding that
the new chemical substance will not present an
unreasonable risk to health or the environment during
the test marketing activities Section 720 38 of the
Rule identifies the type of information you should
submit with a test-marketing exemption application
EPA must approve or deny the application withm
45 days If you do not provide sufficient information
for EPA to make its determination withm 45 days,
the Agency will deny the request
You should send applications for test-marketing
exemptions to the 0TS Document Control Officer
(TS—793)
P«q« 9
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2 Occupational Exposure
Column II] - Describe each soec:f>c activity in tut opera
tion during wfiicn workers may be exposed to me nev\,
che-mcal suDttance Such activities nnav include charging
Teactor vesse's sanoiing for Quality control transferring
materials from one work area 10 anoint' drumming
bulk loaning changing filters ana cleaning equipment
Activities must be described »»en if workers wear oro
lective eauipment (Material Saletv Data Sheets indicating
recommenoec orotecuve eauioment should oe submitted as
DS't of Hazard information in Dan l section C
suDsecnon 3 of trie nonce form )
Column 12) - Indicate the physical form of the new
substance at the time of enclosure e g , solid (crystals,
granules, oowoei dust! liquid (solution paste slurry
emulsion, mist spray], gas Ivapor, fumel even tl workers
wear protective equipment
Column (3) — Estimate the maximum number coworkers
involved in each specific activity based on the estimated
maximum 12 month procuction volume
Column (41 - Enter the maximum duration that any one
worker wni engage in the activity in nours/dav. eg,
8 hours/day
Column 15V - Enter the maximum duration that any one
worker will engage m ihe activity in djys'vea'. '9 200
days/year, based on tne estimated maximum production
volume
Note that you must make separate confidentiality claims
for the description of worker activity, physical form of the
new substance, numoer of workers exposed and duration
of expoture
J. Environment*) Release and Disposal
Column (1) - For each release point indicated m the
process description (part II, section A, subsection W<34®+
the notice form, enter the corresponding number
Column (21 - Estimate the amount of tl»e new chemical |m
kg/day for continuous ope-ations or kgtoateh tor batch
operations) that will be released from the release point
before entering control technology Base your estimate on
the estimated maximum 12 month production volume
Column (3) — Enter the media (air, lard, water) into which
the release stream discos'ges (whether or not control
technology is used)
Column (4) - For releases to the nr and water, describe The
type of technology used to control the release of the new
chemical Examples of control technologies include carbon
filter, scrubber, ans released directly to the environment
For disposal on land, describe the landfill site conitruciior
ImduOmg liners) and handling procedures Describe land
fill containers
Column (SI - Mark (X) the appropriate box and/or speoty
o;nei Destinations ol water releases
Note that you must make separate confidentiality claims
for the release number and amourt of new chemical sub-
stance released and other release and disposal information
Section 8 - Industrial S«tn Controlled fry Others
Complete a separate sec'ion 8 for each rvne of Drocessi-g 3:
use operation istoc-aieC w»tn tach categor. 0' use ispec- 'ie:
n oart 1 section C subsectio" Jo1 a: industrial sites ,-ou cc
not CCnirol
Describe each typical processing or use ODe'ai'On to tne
miwmvim	possible liom information known to 0'
reasonably ascertainable by you Idenn'y the unit operation
steps that may occur during tne operation Estimate the
number of sues at whicn tne operation is likely to occur
Identify situations m wmcfi potential exposure to and
erwiionmerital release of the new chemical substance may
occur Estimate the percent formulation of the new enemies
substance in products manufactured <01 commercial purposes
m the operation or as used in the operation ana indicate its
physical form Estimate the maximum numoer of workers
exposed to the new substance during the operation, ano
duration of potential exposure
Provide an estima.e of the maximum amount of new chemical
substance m kilograms per year that may oe released to the
workplace air. water, or land under typical operating cona
tions if possible Describe any control technology wrucri
may Oe used to limit worker exposure and environmental
release Identify byproducts wnieh may result from the
operation Describe destinations of potential releases to the
environment
For example, 1oi a paint spraying operation at an automobile
plant you might provide the following information il you
know or can reasonably ascertain n
Pamt spraying of automobiles will tike olace «n ventilated
spij'r booths wrfitch have filters or water curtains to collect
overipray Itypically 20-50 percent) Abeur 100 - 500
¦workers will be involved for 6 hourifaay. 240 daysryear
in spray operations involving the new chemical substance
The new substance usually will be m a 6-10 percent formu
lation m the paint Overtpray will be lanrtfilled. either as
part of the filter or as sludge from the water curiam
Solvent will be captured in an absorber and incinerated
Releases c»1 new chemical substance to water and air are
expected to be less than 1,000 kg'yr Wo'ke' exposure is
typically limned by the use of respirators that are approved
for the solvent and paint particulate by NIOSH
Freouently, you may also be able to provide other iMo'maivon
on exposure and release of the new substance or products con
taming the new substance during the operation
Ptrt III - LIST OF ATTACHMENTS
Attach any continuation sheets for sections o1 the 1oim, tesi
data arid other data (including phyncaf/chemical property and
structure activity information), and optional information
after 1he last page of the form Clearly identify the attach
ment and the section to which it relates, if appropriate
Number cpnsecutively the pages of the attachments Enter
the inclusive page numbers of each attachment Enter the
total number ol pages in the notice on page 1 of the form
Mark (X) the "Confidential" box next to any attachment
name you claim as confidential Head part I, section C 1 on
page 2 of this manual for guidance on how to cla>m any
information in an attachment as confidential You musi
include with the sanitized copy of the notice a sanitned
version of any attachment m which you claim information
as confidential
P»ge 1
-------
~	a tiCw q a^c
uono'stery
~	an antioxidant m fuei oils ana 1 ubricai^xs
t2i Estimate tne 2ercen* trie to'o'' coGuc'ion volume
that you anticipate vwill oe manufactured for eacn
category of use
(3) Estimate the we«gh; oe'cert o' tne new cnemical
substance :naf will oe contamec -n an, 'ormuiated
miKTure, mipension, emulnon solution, or gel
associated wtf- eac*^ categor- o* use as many
factured for conT-ierciai ourooses at sites unoer
your control VVnere the suOSiance is distributed
from you; site neat enter N A 11or not aool'CaDie)
For example
P c—iu'ai»c
Product as
Cd'^GC". 0' U*P	Manu'ac j '1
^ C o« unkipig noa-sv>0\jteo
age" *o	nea
too iv • t oe
coatings tor
metai surfaces
2 Sufiaciari r sufa\	ti
auiomoD'"9	wj- Uusoe^i'C'»
10rjv A31
®»'CPn 0*
N*ia C^e~"cai
Substance
N < A
3 AntiO*Kja-l
ir. luoricami
luOf'Can (lO'uI'Of)
4 P»ber'eac*	Dowde *ad%e
0*e 'or "vor. (Tuiyiei
ca'oetmg ara
up^o'tierv
5 Colorant 'o
oaoer anc:
otner ceuu^itcj
COlO'J^ t llOl wUO" I
7
05
55
6 Fiampretaro none Qistnouiea	N/A
• ot (or cotton neat
apoa'ei
(4! Mark (X) to indicate if the category of use is sice
limited Also mark IX) to indicate vvhethe' the
substance is intended for industrial, commercial,
and/or consumer use, as defined below
Site-limited - The substance will be used only on
the contiguous property unit where a is manufac
tured and not intentionally distributed outside thai
site except for waste disposal This includes all
factories, storage places, and warehouses ai the site
An example would be an intermediate which is
further reacted on-site to produce a pesticide
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 estab
lishmenu, use by painting contractors, or use by
roofers in commercial building construction
Consumer — The new chemical substance or
produces containing the substance will be used by
private individuals trv or around a residence, or
during recreation, or for an* ofer De^onai uje or
enioyie" e g autoiiotive ool.s" jyec wea'.r.g
»DO»tel household cleaners etc
Mark more than one Bo* i< aDD'0D"ate For example
i surfactant in an automobile wa* r"iav have a £or,sjrnef
use in liauid wax a commeroa' use m auto washes ar.c
an industrial use oy automobile manufacture's
Note that you must maVe separate confidential,ty c'air-s
for tne description of trie category of use the percent of
proauction devoted to eacK category the formulation of
tne new substance ana otner use informa:,on
The information in this section is used to evaluate potential
exposure and release of the new substance If you wish to
provioe any additional information wnicn would assist >r
this analysis it may be submitted as opuonai information
b Generic use description - For each category of use
description which is claimed as confidential provioe
a generic description of the category Identify the
category of use to wtiich the generic description applies
Tne generic use should reveai (he intended category of
uw lo the maximum entent possible For example the
specific use of a new substance as an antioxidant in a
lubricant could be described genetically as a lubricant
additive, a fiber reactive dye for nylon carpeting could
be described genericaliy as a dye for fioers If such a
generic description does not provide a sufficient mdica
Hon of potential exposure the description can alio
describe the degree of cpntamment o' the new chemical
substance, as shown in the list below
Degree oi Containment
la) destructive use
(e g fuels fuel additives,
chemical intermediates)
(b)	contained use	(e g , catalysts used m closed
processes certain photo
graphic chemicals capacitor
fluids!
(c)	open, non dispersive (eg printing mkj textiles
use	dyes plasticuers adhesives,
liquid paints resins)
Id) dispersive use	(eg cutting fluids fabric
softeners automopiie tire
rubber I
(e) highly dispersive use (eg. pesticides, fertilizers,
salt for deicing, paint
solvents, spray paints)
(f) other
(describe)
3. Hazard information - Include in the notice a copy or
reasonable facsimile of any hazard warning statement, label,
material safety data sheet, or other information which will
be provided to any«person regarding protective equipment
or practices 'or the safe transport, use. or disposal of the
new chemical substance If hazard warning information is
not yet prepared, describe the statement you intend to
provide, if any You are not required to develop hazard
warning statements for thu nonce if you do not otherwise
intend to do so Identify copies of hazard warning state
ments or other hazard information that you anach m
Part III, List of Attachments
Paje 5
-------
Tr.e na-- e c* the reaction -nusi D« aesc'.DeC as
sDeo'icait, as ooisioie ie ; acetviauor aikau-,»
hycKoivsii d azot :at.oni Por substances mat ha»e
been D'ocjcea .vitnout cnemicai reaction (e g b/
chemical e«t action ''om a natural source) spec f1
the sojrce the Droauct'Oi"' cocess ana me nature
o' the procuc;
13' if vou	'o manufac'ure a Class 2 cnemical
sussta-ce «if n a iir-,.tec range of doss¦ e com
DCs . o^s reoo'" the range For example a
manufacture' filing a notice for chlorinated
nashtnaieie might specify a compositional range of
20—<0 percent cnionne Oy weigh; lr, determining
the range you mav have to cons.ce' tne reaction
conditions the catalyst, or the purification process
that may be used to produce tne substance and
other factors You should provide the range of
composition m weight percent for each specific
component or class of components that you inteno
to manufacture for commercial purposes indicate
the typical composition or any actual values for
samples
(4) Provide a partial or incomplete structural diagram
if possible The diagram should indicate the char
acteristic structure or variable compositional
elements of the substance
2 Polymers
a Indicate the lowest number average molecular weight of
any composition of the polymer you intend to manu
facture Identify the method vou used to make this
determination (e g , vapor pressure osmometry or other
colligative property determinations, gel permeation
chromatography light scattering, or various correlative
techniques) If you have not determined number
average molecular weight by analytical methods briefly
explain the basis for your estimate Indicate the
maximum weight percent of low molecular weight
species below 500 and oelow 1,000 absolute moiecu'ar
weight Include the weight of oligomenc reaction
products (including molecules TBrfrieTT Tfl3T STf TTOP
poiymer moleculesi m your determination bu' do not
include the weight of residual monomers or other
reactants Attach test data supporting your estimate
if you do not have actual test data, provide an estimate
and describe the basis for the estimate
b (1) Provide the chemical name and CAS Registry
Numoer of each reactant used in the manufacture
of the polymer, including those used at 2 weight
percent or less Reactants include monomers,
catalysts, free radical initiators, and cross-linking,
chain transfer, and other reactive agents that are
used intentionally to become chemically a part of
the polymer composition If a prepolymer is used
in the manufacture of the polymer, list the pre
polymer in terms of its component reactants
Identify by bracketing or another method that the
monomers are components of a prepolymer
(2) For each reactant (including monomers), indicate its
typical weight percent m the polymer The weight
percent of a reactant is the weight of the reactant
charged to the reactor divided by the weight of the
polymeric chemical manufactured (times 100)
Thus, the weight percent of reactant A of a polymer
manufactured from reactants A. 8. and C u the
weight of A charged to the reactor divided by
the dry weight of the polymer A-8-C (times 100)
I' /Ou use a prepoi<~ie' r :ne manulac'ur; o' ¦"»
OGiYme nios' aeterr-ire t~e (veign; oe ce"
as component reac*ants For eiamo'e the wg'
oe'cent of E used >n the manufacture of a ooi.-^e-
from reaciants A 8 and C and prepoiyme' D-E
is tne total we'gn of monomei £ in the preooiy
mer 0-E usea dividea dv Tne weigrt of the eo', -ne*
A —8 —C—0 —t manufacturers itimes 100i You
must Droviae the identity and typical weigr-
percent of each monomer ana otner reactant usee r
the manufacture of the dc',mer regardless of t-e
weignt percent at whicn n .j usea If you will
tvoicaiI»¦ manufacture the polymer using a reactar-
m a range o' weigh; composition you may maicate
the range of weight percent instead of the ryS'Cai
weignt percent
(3) Reactants used at greater than 2 weight Percent
the manufacture of the polymer are mciuoea as
part of Iht description of the polymer listed on tr.e
TSCA Chemical Substance Inventory However
you may choose whether or not to indude reactants
used at 2 weight percent or less m ttie Inventory
description of the polymer
Mark (XI trif dentity column il you wani a
reactant press-- at less than 2 weight percent to
be included ir. tne description of tne polymer whicn
is added to the Inventory
(41 Indicate the maximum weight percem of each
reactant that ma,- be present as a residual (unre
acteC materia!) m tne polymer as manuiactured lor
commercial purposes
Note that you must make separate confidentiality claims
for reactant identity, composition information ana
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 the polymer
molecules For example, you could identify the linkages
formed during poiymen:ation the functional groups
present, the range and typical values for the number of
repeating structural unit' and the relative molar rapos
of the precursors Indicate if the repeating substructures
are arranged in a nonrandom order such as in graft or
block arrangements
For example
HO-R-O-IC-R -C-O-R-O) -H
n
3^n<10
where fl may be eitner
-CH2CH2- or -CH2CH-
CH3
and R' may be either
-^0)- or -(CH2)4-
Approximate relative mole ratios of precursors
diethyl tereohthalaie	2 0
adipic Kid	l 5
ethylene glycol	1 0
propylene glycol	3 0
Page 3
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I. INSTRUCTIONS FOR COMPLETING THE
PREMANUFACTURE NOTICE FORM
A General Instructions
Complete the oremanufacture notice form using a tvoe
writer or Dv printing legioiy >n black ink All infor-tat on
mult oe in Enghjn Provide all information requested on
the notice form to the extent that you know or can
reaionaDiv ascertain n If you do not know or cannot
reasonaoiv asceiain the information enter 'NK (for
not known or not reasonably ascertainable) You mav
artacn continuation sheets to any subjection or item on
the form Mark (XI the appropriate bo* on the notice
form if you attach continuation sheen
The use of the term 'manufacture" in this manual includes
both manufacture md imoort Imoorters must fully
comply with the information requirements outlined in the
P'emanufacture Notification Rule However, imoorters are
not required to submit any data which relates solely to
exposure to humans or the environment outi.de the United
States under I 720 50(d) of the Rule Importers must
submit nonexoosure data such as data on health effects
(including epidemiological studies) ecological effects
physical and chemical properties, or environmental fate
characteristics and exposure information on sites under
men control within the United States
You may photocopy the notice form sections of the form,
or this manual as frequently as you need
Send your comnleted notice to the Office of Toxic Sub
stances (OTS) Document Control Officer (TS—793), whose
address appears on page one of the form
B T*rt Data and Other Data
You are also required to provide test data on the health and
environmental effects of the new chemical substance m
your possession or control, and a description of any other
health and environmental effects data on the substance
known to or reasonably ascertainable by you Standard
literature citations may be submitted for data in the open
scientific literature Complete test data, not summaries of
data, must be submitted iflhey do notlppear m [he open
literature Examples of the types of teit data you must
submit are provided in Appendix A of this manual For
additional information on health and safety studies and
on submitting test data, see H 720 3 and 720 SO of the
Premanufactute Notification Rule Attach test data to the
notice form and reference it by page number in Part III.
List of Attachments
You are not required to submit any data previously tub
mitted to EPA with no claims of confidential^ if you
identity 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 resubmit the data with
the notice and any claim of confidentiality under 172030
of the Rule You also are not required to tubmii data
related solely to pioduct efficacy This exception does not
apply to information required in the notice, test data, or
other data
C Confidentiality
1 Aliening claims
You may assert a claim of confidentiality for any infor-
mation submitted to EPA To assert confidentiality
claims for specific information on The form (e ;
suDmitler identity chemicai identity or u« info'-ia
tionl mark IX) m the "Confidential box on tne 
dential business information
To assert confidentiality claims for information in
attachments tc the form provide a complete coov of
the attachment that clearly indicates (eg by circling
or bracketing) the information you wish to ciaim as
confidential Bracket only the specific information you
claim as confidential For example if you submit a
study which contains a physical or chemical property
and it is only that property which you wish to claim as
confidential, bracket only that property Do not simpi.
stamp Confidential' on the page which contains that
properly
if you claim the identity of the new chemical subsianct
or its category of use as confidential, you must provide a
generic description of this information, as indicated m
the appropriate sections of the form Guidance on
developing generic names is given in the instructions for
those sections of this Manual
To ensure that no confidential information is disclosed
to the public, you must submit a second copy of the
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 tne sanitized copy
with your submission, the submission will be incomplete
and the review period will not begin
2 Subttantitting daimi
You are not required to provide substantiation of any
confidentiality claim when you submit your notice
However you must substantiate your claim of confi
dentiality for chemical identity at the time you submit
a notice of commencement of manufacture, if you want
EPA to maintain your confidentiality claim after you
begin manufacture To substantiate that claim, you
must provide EPA with detailed answers to the questions
which appear in the Premanufacture Notification Rule
(I 720 85(b)l3l(iv)) This substantiation must accom
pany 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
D. Certification
The official named in part I. section A of the form, as the
person suOmitting the notice, must ngn the certification
on page two of the notiee form This official is responsible
for the truth and accuracy of each statement in the certifi
cation II an agmt aunts you in preparing the notice, the
agent must also sign the certification
Page 1
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&EPA
uINSTRUCTIONS MANUAL FOR
Protection Agenc>
v onmen'	PREMANUFACTURE NOTIFICATION
OF NEW CHEMICAL SUBSTANCES
EPA 7710 25(11 (5 23 831	OFFICE OF TOXIC SuBSTANCES	Wjih.ng,0r 0 C 2W6C
The U S Environment*! Protection Agency lEPAl his Brewed this manual toassist you in submitting
a premanu'acture notice under section 5 of the Toxic Substanoes Control Act (T5CAI The manual
provides mitructiom on submitting a premanufacture notice aliening confidentiality claims, completing
the notice form and submitting test data and optional information Be	9
2.	Research and development exemption	9
3.	Ted marketing exemptions	9
4 Section Slh||4) exemptions	10
0 When to Submit a Notice	10
E. Consolidated Notices	10
F Submission of Information by Others	10
1. Submission by tn agem	10
2	Joinl submissions	10
3. Other submissions	10
G Consultation with EPA Concerning the Premanufacture Notice	10
1. Before notice submission	10
2 During notice review	11
H.	Notice of Commencement of Manufacture	11
I.	Recordkeeping	11
Appendix A — Examples of Test Oata
Appendix B - Physical and Chemical Properties Worksheet
12
13
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k-
Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER
Complete taction A lot each ryp« of manulactur*, procMalng. or uae operation Involving the new chemical
•ubrLanca at tftdurtrial ihai vou control
Mark IX) the "Confidential bo* next to any item you claim as confidential
1. Operation description
a. Identity— Enter the identity o1 the site at which the operation will occm
' Confi
denial ,
Name
Site address (number and street)
City. County State ZIP code
If the tame operation will occur at more than one site enter the number of sites
Identify the additional sites on a continuation sheet
~ Mark IX) rhis bo* if you anacft a continuation sheet
b Type -
Mark IX)
O Manufacturing
D Processing
Use
C- Amount and Duration - Complete ' or 2 as appropriate
1 Batch
Maximum kg/batch
i Hours/batch
I
1 Baiches'vear
Maximum kg/day
' Hours day
Days year
2 Continuous
d. Process description
(1) Diagram the maior unit operation steps ana cnemicai conversions
421 Provide the identity the approximate weight (by kg/day or kg/batch), and entry point of all feedstocks (including reactanis
solvents, and catalysts:
(3) Identify by number the points of release to the environment of the new chemical substance
-------
Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
~ Section A - INDUSTRIAL SITES CONTROLLED BY THE 8UBMITTER - Continued
2. Occupational Exposwrt — You must make seperaie confidentially Claims for the description of worker activity physical lorm of tne e w cn^mu
substance number o' workers exposed end duration of activity Mark (X* the ' Confidentiel' box next to any item you claim as conficentiai
(1) - Descnbe the sctivities in wnicr. workers mey be sxposec to tt>« new chemical substance Include activities in which women wear protective e^*
(21 - Mark IXI this column if entry in column (11 is confidential
(3) - Indicate the physical formlsl of the new chemical substance at the time of exposure
14) - Mark (XI this column if entry in column 131 is confidential
(51 — Estimate the maximum number of workers involved in each scttvrty
16) - Mark (XI rhis column rf entry in column (51 is confidential
(7) and IB) — Estimate the maximum duration of the activity for any worker in hours per day and days per year
(9) - Mark (XI this column rf entries in columns 171 and 18'ire confidential
Worker activity
(1)
Confi-
dential
12)
Physical
formts)
(31
Confi-
dential
14)
Maximum
number
15)
Confi-
dential
>6)
Maxim jr
Hrs/dev
(7)
n duration 1 ConH-
Days yr 1 deniia
 1


































I
1









Li Mark IXI thiM box if you attach a continuation theat
3. Environmental Raioasa and Disposal - You must make separate confidentiality claims tor the release number and the amount of tne new cnem
suostance released ano other release and disposal information Mark (X) the "Confidential' box next to each item you claim at confidential
(1)	- Enter the number of each release point identified in the process description, part It. section A. subsection ld(3)
(2)	- Estimate the emount of the new chemical substance releaaed directly to the environment or into control technology (in kg/day or kg/batch!
(3)	- Mark (X) this column if entries in columns (1) and (2) ere confidential
14) — Identify the media (air land, or waterl to which the new substance will be released from that release point
(5) - Describe control technology, rf any. that will ba used to limit the release of the new substance to the environment For
releases disposed of on land charactenxe the disposal method
(61 - Mark (X) this column if entries in columns 141 and 151 are confidential
(7) — Identify the destination)*) of releases to water.
Release
Number
(1)
Amount of new substance
released
(2)
Confi-
dential
13)
Madia of
release
14)
Control technology
15)
Cc
dei
16.




































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Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS
CompttU —ctfcjo ¦ for each type of proc*Mte*9 Of wt opwillon Involving lh« new chemicel aubatanca at that you do not control
To clsim information in this section is confidential circle or bracket the ip*cffle information that you claim as confidential
Operation description
Describe the typical processing or un operation tdonufy the unit operation steps which may occur during the operation Estimate
the number of sites at wfiicn the operation is tikerfy to occur Identify situations in which worner exposure to and/or environmental
ralaaae of the new chemical substance may octu/ Estimate the percem of new chemical substance as formulated in products
manufactured for commercial purposes 
-------
Part III - LIST OF ATTACHMENTS
Anac/i continuation (heats 'or lections of the form and teat data and other data (including physical/chemical properties and
rtrvicture/activrtv information) and optional information after this page Clearly identify the attachment and the section of the form to
whioh it relates rf appropriate Number consecutively the pages of the attachments In the column below, enter the inclusive page
number* of each attachment
Mark (XI the "Confiderrtial" bo* nert to any attachment nam* you claim as confidential Bead the Iftfftructlona Manual for
guidance on how to claim any information in an attachment as confidential You must include with the sanitized copy of the notice
form s sanitized version of any attachment in which you claim information as confiderrtial
Attachment name
Anachmeni | Conft
page numbensi i demii




1
!





















| |










































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APPENDIX D
GLOVE TESTING GUIDELINES
-------
A t
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
km
v	WASHINGTON, D C 20460
4t
OpfiCEOf
pesticides anq ro* ic sjbst-
memorandum
SUBJECT: Glove Requirements for Section 5(e) Orders
FROM: A. E. Corroy 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
the glove requirements and be able to document pertinent
information during these inspections.
The key element of the inspection will be to document trie
glove requi regents 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 fn the report concerm nq glove
requirements will be forwarded to the Economics and Technology
Division of OTS for their information and review.
These section 5(e) inspection procedures are effective
immediately. If you have any questions, please contact
Michael Hackett of my staff at 382- 7851 .
Attachment
-------
, y g r a i x 5		_ _ Sect • or 5(e) Inspect' ^~cc?
Document at i on~7"or Glove Requirements in 5(e) Orders
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, peretration 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 or.
the glove mate-ial wrien challenged by the Pmn chemical (including
protocol for the test); and 2) published results of testing glove
materials with analogues of the PMN chemical {;.e., chemicals ir the
same chemical class evaluated by glove manufac.jrers or other
experts). The record documenting glove selection should include.
1)	an analysis of the conditions of potential dermal cortact
(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 submi tter) ;
3)	any published data (on analogues or the PMN) used by the
submitter in determining the acceptabi1ity of the glove
selected; and
4)	a statement describing tne specific glove material(s)
selected and the reasons for concluding that the
mate"ial(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 tne conditions of exposure noted in
point 1, in particula- reconciling any differences
between chemical substances as tested and the substance
as expected to be encountered by workers (e.g.,
test of pure compound but contact with a solution).
For each 5(e) investigation where use of gloves are required,
the inspector snould collect documentation on glove selection ana
use and include this information as an exhibit to tne facility
inspection report. This report should be forwarded to OCM for
compliance review as soon as possible. UCM will forward i r.f ormat' or
on glove selection and use to UTS for thei- information and review.
May iy<*3 Upd
A-^3
¦spection Manual
Four Section 5 Manua 1
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APPENDIX E
EPA HQ § 5 INSPECTION GUIDELINES
-------
Chapter One
Overview of Section 5
Section 5 Recuiremencs
Beginning July 1, 1979, all "new" chemicals are subject to premanufacture
notification (PUS) review by EPA under Section 5 of TSCA, prior to being
manufactured or imported for a commercial purpose. A "new" chemical is a
substance that:
•	Does not appear on the Inventory of Existing Chemical Substances
published under Section 8(b) of TSCA;
•	Is not specifically excluded from TSCA mandate (e.g., pesticides,
drugs, cosmetics); and
•	Is not exempt or excluded from review under Section 5.
Currently, there are two circumstances in which chemical substances are
exempted from the PMN requirements:
•	Research and Development. Companies are automatically exempted
from PMM review if they manufacture small quantities of a
substance for research and development and comply with the
notification requirements of Section 5(h)(3).
•	Test Marketing. Upon application, the administrator may also
exempt a company from PMM review to manufacture a chemical for
test marketing purposes. Often, test marketing is permitted after
a company agrees to comply with certain restrictions concerning
production, distribution, or uae. EPA may also deny a test
marketing request.
At present, Section 5 regulations are proposed. Therefore, any enforcement
activity is based on the statutory requirements.
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Chae:er One
Section 5 FEB Facte and Strategics
PKS Review Process
The premanufscture review process ia centered around the aotlces which
industry is required to submit to EPA prior to aanufacturing a "tiev." che-ical
for a Conner::!, purpose. EPA ha« 90 i»yt to review the information
submitted in a notice, which should Include Che chemical identity, che use(s)
of the chemical substance, tad Any other information &s outlined in Section
5(d)(1). If EPA takes no action at the aod of thia period, Chen the
submitter nay begin manufacture.
Several other options are available to Che Agency after the 90 day period
including:
e Extending the review period up -to 90 days or suspending che review
period;
a Issuing an order, rule or Infection under Section 5(e) or 5(f) to
restrict or baa any phase at the «ubatance'a manufacture,
processing, distribution, use, or dispoaal; and
• Tagging a chemical {or a gignifleanc Mew Uae Rule (SNUB.) at a
later dace. (At thia ciae Che Agency has noc promulgated any
SNURb i but a list of 9MUR candid at— axiats.)
At any time during the review period, notice aubmlttera may withdraw their
PHN, and EPA may reject a notice aa invalid, for lack, of sufficient
information.
Objective of laaoectlon Proarac
The objective of che Secclon 5 impactions ass to ensure that:
~	Firm6 manufacturing new 76CA aubctaooaa have complied with PKN
requirements.
•	Firms subject to Section 5(a) or 5(f) orders, rules, or
injunctions are coaplyiag vtth specific restrictions.
a Firms are coaplyiag with the saatrlctloae placed oo their test
marketlag exeapciona.
Because of che lncetrelacionahlp batveao SecClooa 5 and 8(b), several of che
Clem's Inventory submissions will be checked duxlog a Section 5 inspection to
anaure that all chemicals submitted for the Inventory were properly
reporced. If they were noc properly reported, than these chemicals are
subjecc to PHN review.
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CharterOne
Section 5 PKH Facta and Strategies
Selecclc- of Companies
Companies subject to Section 5 inspections have been selected b> tie D[f::e
of Pesticides and Toxic Substances (OPTS) based on information reported ir.
PMNs, in Test Market Exemption (TK£) applications, and in tips and
complaints. (See Appendix 1, "Section 5 Inspection Scheme" for a more
detailed description of how companies were selected.) Future targets will be
randomly selected using different criteria, such as type of industr>, amour.:
of toxic checicals produced, etc.
Headquarters has prepared a package of information for each company selected
for inspection. These packages (described on page 2-1) contain all the
Information the inspector will need to review prior to an inspection. Each
package will include a one-page Target Sheet for each PKN or THE and
supporting documents.
Types of Section 5 Inspections
There are several types of PMH Inspections, each with Its own set of
procedures. The type depends on Che purpose of the inspection, which is
clearly outlined on the Target Sheet, for the first round of companies to be
investigated, there are three categories from which to select. They are
explained in detail on pages 2— L5 through 2-20, and are briefly summarized
below:
•	Test Marketing Exemption Granted with Restrictions. Determine
which restrictions apply co the company, such as production and
use limits, and then examine records, data and manufacturing
processes to determine If Che company Is complying with the
restrictions.
•	PMK Withdrawn. Incomplete or Review Period Extended or Suspended;
or TM£ Withdrawn or Denied. Review manufacturing, sales, and
research and development records for any evidence that the
substance is manufactured for commercial purposes.
•	Company Subject to 5(e). 5(f) Orders. Rules, or Injunctions.
Determine whether the Agency has restricted or banned certain
activities and then examine records co determine compliance.
Confidentiality Considerations
Because of the sensitive nature of ouch of the information submitted to the
Agency under the Section 5 program, special procedures for handling this
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Section 3 WW facts ud Strate«ie»
information have been developed. (See Appendix 2, "Recommended Procedures
for Enforceoent Personnel Responsible for Handling Section 5 Information.")
These are recommended procedures Co ensure efficient coordination and a
lesser burden on enforcement personnel. These procedures supplement existing
procedures in the TSCA Bsse Inspection Manual (hereafter referred to as the
TSCA Manual) and the TSCA Security Manual.
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September 1981
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Chapter Two
Inspection
Procedures
Contents		Page
1.	Pre-Inspectlon Actlvltifcj
PMN Inspection Package	2-1
Xarget Sheet	2-1
Supporting Documents	2-2
Confidentiality Considerations	2-2
PMN Inspection Planning	2-2
Pre-Revlew Meeting	2-2
Purpose of Inspection	2-3
Inspection Site(s)	2-3
Regional Lead Responsibility	2-k
Records Review Plan	2-t
Advance Notification	2-6
Confidentiality Considerations	2-5
Section 8(b) Inspection Plan	2-5
Preparation of Documents and Equipment	2-6
2.	Inspection Procedures
Entry	2-7
Opening Conference	2-7
General Discussion	2-7
Company Information	2-7
Confidentiality Considerations	2-3
Company Research and Development Policy	2-8
Records Review Plan	2-9
Inspection Guidelines
Introduction	2-11
Records Overview	2-11
Evidene Sources Chart	2-12
Documentation of Possible Violations	2-13
Physical Samples	2-13
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VoIum Four: Section 5 Manual
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Specific Guidelines
Tes: Marketing Exesption Granted Uicr.
Restrictions	2-15
PMJ< Withdrawn, Incomplete, or Review
Period Extended or Suspended; TV.E
Withdrawn or Denied	2-17
Section 5(e) and 5(f) Orders, Rules, or
Injunctions	2-19
Closing Conference	2-21
Report Preparation	2-21
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Chapter Two
Pre-lnspection Activities
Because of the complexity of PMN Inspections, detailed pre-inspection
preparation is required. In addition to che procedures detailed 1- Chapter
3-1 of the TSCA Manual, an overall plan for each inspection is Deeded to
ensure that the inspection goes smoothly. Following are guidelines for this
planning effort.
PMS Inspection Package
EPA Headquarters will select companies for inspection based or. tne criteria
discussed above and in Appendix 1. For each company selected, an inspection
package will be sent to the Region responsible for performing the
Inspection. The package will contain Target Sheets (see Appendix 3) and any
supporting documents needed to conduct Che Inspection.
Target Sheet
The Target Sheet is a one-page summary of all the Agency's information on a
particular PM.N or TME. Generally, one chemical substance is described on
each Target Sheet. In some cases, however, a group of related chemicals will
be on che same sheet. For each company to be inspected, th-re inay be more
than one Target Sheet If several of the company's PMN submissions or TMEs are
to be investigated. Target Sheets will also be prepared if a coopany has a
Significant New Use Rule (SNUR) candidate(6).
The Target Sheet shows:
« PHS or THE number (as assigned by OPTS).
•	Significant dates, including when the Agency received the PMN or
THE and the date it was granted or denied.
•	Company name and address (including both parent company and any
manufacturing and plant sites).
•	Technical contact for che company and phone number.
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v _ _ Q „ T,
v-. a. .er
Pre-Iaspectloc Preparation
cleared fci TSCA CBI., for the purpose of outlinir.g eacn person's
responsibilities. (See Appencix 2, "Pre-Inspection Ac:iv_:^es," for f^rcir'
information.)
P-irjose of Inspecticn.
The "Disposition" line on the Target Sheet -wi. 11 state the reason for the
inspection, that is, whether the PMN was withdrawn, susper.aea, denied, etc,;
whetner the TME was denied or granted with restrictions; ^nether the cocpir^
is the subject of a 5(e), 5(f) order, rule or injunction; or whether trie
chemical substance is a SNUR candidate.
• Significant New Use Rule Candidates. Companies have not been
targeted for Inspection on the basis of SNUR candidates onlv.
However, if a company Is targeted for another reason, the lr-spec-
tor should examine records that the company keeps on any SNUR
candidates to detec^liw if the company is manufacturing the
substance in the manner described in the PMN. Generally, the
- chemical substance becomes a SNUR candidate if the Agency is
concerned that another use, a different manufacturing process, or
increased production will increase worker exposure or environ-
mental release to che extent that there will be concern.
Therefore, the Agency would like to be informed if tie substance
is being manufactured in volumes much greater than tint outlined
in the PM.V, etc.
Inspection Site(s)
The Target Sheet will list the parent company and any plant site(s^
identified by the company in the PMN or TME. If the company is small, there
will generally be only one addr-i^s of bjsLness. On occasion, the company
specifically identifies one manufacturing plant at which they will make the
chemical substance, and in other cases, they will list several possible sites
of manufacture.
The technical contact must be consulted in advance to determine the
appropriate site for the inspection (see "Advance Notification," below).
Generally, the reason for the inspection will dictate the location of the
inspection. For TMIs granted with restrictions and Section 5(e) or (f)
orders, rules, or injunctions where activities are limited, the inspection
should be conducted at the plant site where manufacturing cako pl-ioe. For
PHNs withdrawn or Incomplete, TMEs withdrawn or denied, and 5(e) or 5(f)
orders where activities are banned completely, it may be more advisable to
first inspect where che Research and Development, Commercial Development and
Marketing files are located. In these cases, manufacturing for commercial
purposes Is not allowed under aay circumstances, so inspecting the
manutaccurl i£ 
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Regional lead Responsibility
If the technical contact is in one Region and the plant sites are in a
different Region(s), a lead Region will be designated by Heacauarters For
TMEs granted witn restrictions and where activities are limited oy Sc on
5(e) or 5(f) orders, rules, or injunctions, the lead Region will be t-,e one
in which the manufacturing plant operates. In all other cases, the lead
Region will be the one in which the technical contact operates. Tne lead
Region has responsibility for the inspection and will:
•	Receive a complete Inspection Pac kage.
•	Consult in advance with the technical contact as discussed below
Note: For TMEs granted with restrictions, the lead Region should
notify the Region where the technical contact is located prior to
calling Che technical contact. This will ensure interregional
coordination, and may avoid potential problems if a Region has an
ongoing case with the company in question.
•	Inform contacts in another Region(s) if the inspection should be
conducted at a manufacturing aite in the other Region. In this
case, the appropriate Compliance Monitoring Regional Coordinator
in Headquarters should be contacted immediately. Headquarters
will send a complete Inspection Package to that Region.
Records Review Plan
Several different kinds of records must be reviewed to determine compliance
with the Section 5 requirements, depending on the particular purpose(s) of
the inspection. While it is impossible co determine exactly which records
will be investigated in a given inspection, a plan for reviewing records
based on the dates of relevant applications and submissions and the
purpose(s) of the inspection can be developed. The individual inspection
procedures and list of records provided in this Chapter will guide the
preparation of an overall scheme for record* review.
Advance Notification
Because of the highly technical nature of these inspections, the sensitivity
of the information involved, and the need to ensure that appropriate
personnel and records are available for inspection, the company will, in most
cases, be notified in advance that an inspection is planned. (For
inspections involving certain vell-docuaented complaints or tips, prior
notification of the company may not be desirable. Headquarters will notify
the Region if this is the case.)
The lead Region should telephone the technical contact several days in
advance to arrange for the inspection to:
•	Determine the appropriate site(s) for the inspection, including
identification of where the necessary records, based on the
records review plan, are located. Records that need to be
reviewed should be described as specifically as possible.
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ChsDter Tvo
-napectiota Preparation
•	Ensure that personnel are available to accompars E?A inspectors
daring the inapection.
•	Ensure that someone on sice will be able to make claims of TSCA
CBI.
•	Determine the advisability of having all records transferred to
tne plant site before the inspection.
•	Set an appointment for the inspection.
Note; If the technical contact is uncooperative, the Headquarters
Compliance Monitoring Coordinator should be consulted for
instructions on hov to proceed.
Confidentiality Considerations
'
A blanket waiver has beer obtained from EPA Headquarters so that certain
inspectors can discuss CBI over the phone with the technical contact. See
Appendix 2-A for a discussion of twe specific procedures to follow.
Section 8(b) Inspection Plan
Once the manufacturing site for the inapection has been determined, chemicals
to be reviewed for compliance with Section 8Cb) inventory requirements during
Che Section 5 inspection car be selected.
The objective of this part of the inspection is to determine whether
substances were placed on the Inventory which should have been excluded.
With the assistance of a Regional chemist or individual with industrial
experience, the inspector should determine which of the chemical substances
on the Chemicals in Commerce Information System (CICIS) list for the
manufacturing site fall into one or more of the following categories:
•	Substances noC covered by TSCA (e.g., drugs and pesticides).
•	Low quantities reported, including eero production ranges. (These
may be R&D chemicals.)
•	High-cost chemicals which may be bound for very selective markets,
e.g., isomers and optically active compounds. (These may also be
R&D chemicals.)
•	Chemicals that would generally not be isolated because of lack of
stability, i.e., non-isolated intermediates.
From this list, seversl chemicals should be selected for investigation during
the Section 5 inspection. (Refer to Appendix 4, "Section 8(b) Inspection
Procedures.")
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September 1981
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Chap:er Two
Pre-Inspectlop Preparat lor-
Preparation of DocL~e*:ts and Equipment
Notices and forms should be prepared as detailed In Chapters 3 anc 6 of tne
TSCA Manual.
•	Notice of Inspection. In Section 5 inspections, financial, sales
and research data will be reviewed. Section 11 of TSCA requires
that if such information is to be inspected, it must be specif iec
on the Notice of Inspection. Therefore, the second box on the
Notice should be checked, aod the information to be inspected
6hould be listed. Although the exact records cannot be ldentlf.ec
in advance, the records inspection plan can be used co sumarize
the records to be inspected.
•	Confidential Information. If confidential information must be
taken on the inspection, the inspector should take the mi1 =
amount of CBI to Che company. (See Appendix 2, "Pre-Inspection
Activities", for further information on this.)
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September 1961
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Chapter Two
Inspection Procedures
£ncrv
Follow the procedures for entry in Chapter 3-2 of the TSCA Manual regarding
presentation of credentials, Notice of Inspection and Confidentiality
Notice.
• Denial of Entry. This should not occur if pre-lnspection
activities are followed. However, if entry is denied, notify the
appropriate Regional personnel flr6t. If necessary, the Region
nay then contact UHTSF. Headquarters attorneys for guidance. Refer
to Chapter 3-2 of the TSCA Manual.
Opening Conference
Follow the procedures for Opening Cooference in Chapter 3-3 of the TSCA
Manual.
General Discussion
Outline inspection plans with facility officials. Discuss specifically the
objectives of the Inspection, Including the aubBtances to be Investigated,
Information that will be required, personnel, to be Involved, and records
and/or facilities to be Inspected. Determine tow fanilLar the company is
with Section 5 of TSCA.
Company Information
If appropriate during the course of the Inspection, obtain general background
information or update information existing in Headquarters or Regional
company flies. Information may be available in annual reports, advertising
solicitations, or stockholders' reports. This information may Include:
•	Length of time In business.
•	Types of products manufactured.
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Chapter Tvc
Inspection Procedures
•	Plant sites.
•	Estlnated number and types of employees.
•	General description of physical facilities.
•	General financial Information.
•	Corporate structure (parent company and subsidiary).
•	Names of corporate officers and management structure.
Confidentiality Considerations
Inform appropriate company officials chat they may declassify information
claimed confidential in their original submission or application. Stress
that declassification cannot be made verbally but can be made through a
written request to the Agency. (See Appendix 2, "Opening Conference", for
further information.)
Company Research and Development Policy
Under Section 5(h)(3), companies are permitted to manufacture "smalL"
quantities of substances for R&D without filing a PMN or applying for an
exemption. However, R&D substances are excluded from the Inventory. "Small"
quantitld^ have mt been defiled by the Agency, but there is Che presumption
that an R&D substance is manufactured under the auperv'clon of a technically
qualified person for the purpose of determining lc v jbstance does what it
is supposed to do. Under Section 6(b), there is	.option that chemicals
produced in quantities of less Chan 1,000 lbs. ar. j- chemicals. This same
presumption does not necessarily apply for Section 5 purposes.
Discuss the company's research and development (R&D) policy to establish what
the company's criteria are for determining whether a chemical substance is to
be classified for K&D, including:
• How the manufacturer defines manufacturing for R&D, versus for
tesc marketing, versus for commercial purposes, and
0 What specific procedures are Involved in developing a test
marketing program for a chemical substance.
Copies of written company policy, if they exist, should be obtained. All of
the above may be useful when inspecting companies chat are not permitted to
manufacture their PMN or THE substance (because, for example, their TME was
denied or they withdrew their PMN). If evidence of - -ccure is
discovered in these cases, the coapaoy say claim the	substance is an R&D
chemical. It will be important for che inspector to be able to determine if
the Manufacturer's definition of R&D substance in this case is consistent
with other stated policy, including any information on R&D gathered during a
previous Section 8(b) inspection. It vllL also be useful when investigating
substances reported for the Inventory which appear to be R&D. In general,
when R&D records are examined, it should be determined if these are
consistent with the company's stated or written policy.
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September 1981
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	__		laapectloo Procedures
Records Review P La-*
Review of company records will be the primary tool for determining co-plla-ce
wi:l\ Section 5 and 8(b) requirements. The icst Important cyp^s of re.ores
useful for docuneiuing compliance with Section 5 requirements are
manufacturing, processing, sales, shipment, and R&D records. Storage and
disposal records may alsc be useful.
•	Records Not Readily Accessible. If records are not readily
accessible, agree on a timeframe for the submission of cne
Information. If Che company is uncooperative and deai^ access to
records during thtt Inspection or does not submit records during
the agreed on timeframe, It may be necessary to issue a subpoena.
The Regional attorney should contact QPTSC Headquarters attorneys
for guidance concerning procedures.
•	Chemical Identification In Company Records. To avoLd confusio-.
wnen examining records, discuss chemical terminology with the
appropriate company official. Ask officials how the specific PMN
or TME substances are identified in company records.
Specifically, discuss the relationship between company code names,
tr-ide names, and chemical ID in their records.
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September 1981
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TSCA Inspection Manual	2-10"	September 1981
VoIom Pour: Section 5 tiaoual
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Chapter Tvo
Inspection Procedures
Ir.spectip" Gucell^es
The purpose of the inspection, as identified on the Target Sheet under
"Disposition," determines which set of inspection procedures to folio*-. ~'"e
procedures are discussed in detail on pages 2-15 through 2-20.
Records Overview
Two kinds of records evidence can be used to determine compliance. Direct
evidence Includes records that, by themselves, car. document manufacture,
sales, or disposal. Indirect evidence Includes records that, when u6ed in
combination with other records, will prove manufacture, 6ales or disposal.
Indirect evidence should be accompanied by statements of comparv policy tr.a:
Indicate that these records exist for chemicals manufactured or processed for
commercial purposes.
Example
A company shows you a description of their production
process for the chemical In question. In order to use
this Information as evidence of commercial sales, the
company must also provide evidence that company policy
dictates that production process descriptions are generated
only for products being sold commercially, not for pilot
plant or R&D operations. In addition, this example would
also require information from batch records or other
evidence that the process was being used to produce
quantities of the chemical.
The list on the next page is Intended as an aid to requesting relevant
company records, not as an exhaustive list of sources. Company officials mav
be able to suggest additional sources of information. Analyze each Bource of
information carefully to determine what support it lends to a potential case.
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September 1961
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EVIDENCE SOURCES
DIRECT
ro:s::7
Manufacturing a"d Processing
•	Annual, seal-annual or quarterly
sumr.arv of production
•	Monitoring records
•	Processing records
•	Production schedules showing
dates and amounts
•	Laboratory records
Productior process descriptors
Costing records (Itemizing,
costs of labor and materials)
Inventory records
Quality control procedures
for production process
Toxicity end efficacy data
Analytical methods and results
Material 6afety data sheet
Label ./peerage information
Commercial Distribution
•	Annual sales reports
•	Sales correspondence files
•	Invoices
•	Bills of lading
*
*
•	Inventory records
•	Advertising
•	Sales brochures
•	Salesman's telephone call
record of orders
•	Commercial development/
Marketing call reports
« PhotQfttapKs of product.
Storage and Disposal
Inventory records
Storage records
Blsposal records
Correspondence/complaints
Waste manifests/Operating records
(required under RCRA)

Production waste disposal
records and procedures
Photographs of produces
Shipping record*
Miscellaneous Support Sources

R&D records
Internal memoranda or reports
Written atatementa by company
officials (See Chapter 3-4 of
the TSCA Harwial iot fc-cAdante
concerning how to take a
•tatement.) Written statements
can be used to tie documents one
to another.
• Company policy statements
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September 1981
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inspection Procedures
Documentatlor of Possible Violations
Follow the procedures for documentation in Chapter 3-4 of the TSCA var>ual.
Specific guidance on the information needed for determining civil penalties
may be found in the following sources:
•	Guidelines for Assessment of Civil Penalties under Settlor 16 of
TSCA, September 10. 1980, FEDERAL RZG1STIR, Vol. 45, So. 177,
p. 59770.
•	Section 5 Penalty Policy, August 198C.
•	Inventory Penalty Policy, June 23, 1980.
The following parameters, discussed in the penalty policies and throughout
this document, are used to calculate the penalty in the event a violation is
actually charged:
•	Nature of Violation. Type of violation, i.e., chemical control,
data gathering (recordkeeping), or hazard assessment.
•	Extent of Violation. Amount of the substance involved.
•	Circumstances of Violation. Degree to which the substance was
distributed where possible harm could result.
•	Economic Gains from Violation. Amount of money gamed through
noncompliance•
•	Culpability. Circumstances that led to the violation, including
knowledge of TSCA regulations, control over the violation
occurring, and attitude (e.g., was the company prompt in taking
corrective action).
Physical Samples. In general, physical samples 6hould noc be taken. There
are only a few situations In which a sample should be taken:
•	Based on Headquarters' recommendation.
•	To verify limited environmental or worker exposure.
•	If It Is strongly suspected that the substance is being Illegally
made and existing records and/or statements are noc sufficient to
document this*
If a sample is taken, follow the Agency's "Uniform Chain of Custody
Procedures," dated 10/23/80. Prior to sampling, consult Regional chemists or
NEIC for guidance on methods of collection and storage, amount required for
analysis, chemical stability, analytical methods, and safety procedures for
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Che substance In question. Consult a coroar\ che-Ist before taking a
saaple. If a product is distributed in small quantities, it nay be possi-le
to obtain a stall labeled container.
In many cases, it may not be necessary to analyse the sacple until or unless
the case goes to court. If afLer consulting with the Regional attorney lc
appears that it is not necessary to analyze the sample ionediately, check,
with Regional chemists or NEIJ concerning whether the saiple can be held.
TSCA Inspection Manual	'	" 2-14	September 19&
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I JO frUS I, W ^ w
Test Harketing Exemption Granted With Restrictions
Ob lectives
Detersive if the company is in compliance with TME restrictions	|
placed or the company by the Agency.
Procec-res	"
Dates
On the Target Sheet, note the date the TME application was received, the
date the TME was granted, and the length of the test marketing period.
Restrictions
Each TME will have different restrictions. Some say have as manv as
nine or as few as two. The number and type depends on the Agency's
concern for that chemical. Almost all TMEs have production limits,
Including limits on the amount that can be produced and the time period
during which test marketing can take place. Refer to both the FEDERAL
REGISTER notice granting the exemption and the Target Sheet for a list
of specific restrictions to be investigated, including:
•	Production Limits. Examine manufacturing and processing records.
Identify those records chat 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 6ales volume.
•	Use Limits. Examine bill of lading for statement of use of the
substance.
•	Worker Exposure Limits. Observe plant operations. Inspect manufac-
turing 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. Look for
evidence of the product on the floor or outside the closed system,
Including packaging facilities and storage and transfer lines.
•	Safety Requirements. Determine if the company has material safety
sheets and/or labeling on specified products.
•	Test Data. Ask to see any test data on the substance In question.
•	Dlspoaal Requirements. Examine records that describe the manner or
method of disposal.
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Inspection Proceaures
Records/Data/Ma--facturlng Process Revlev
Exasine data, records, and/or the aaaufsccuring process Co verify
compliance with the test marketing restrictions, as discussed above.
Review records, starting approximately one month prior to the Agency's
receipt of the THE to ensure that manufacture was not premature. Check
records approximately one month after Che expiration dace of the test
marketing period to ensure that time limits have rot been exceeded-
Evidence Collection
If the company has exceeded the Iimit6 or restrictions placed on the
TME substance, copy records or obtain Information to document this and
Co aid case preparation officers Id penalty calculation. Determine:
•	Nature of violation, including failure to keep required records,
exceeding manufacturing or distribution limits, and/or failure to
submit all the data that they possess on the substance.
•	Extent of violation, or the amount of the substance involved. Copv
records that show the total amount of the substance produced (or
Imported) and the time period over which this took place. In thc^
cases where manufacture takes place over a long period of time, t\
example, every day over a 12 month period, monthly summary records
If they exist, may be obtained. Along with the summary records, note
the days on which production took place. If there Is no record of
the days on which production took place, It may be more advisable
to subpoena daily records. Consult with the Regional attorney, who
should then contact OPTSE Headquarters attorneys on the advisability
of doing this.
•	Circumstances of the violation or the degree to which the substance
was distributed where possible harm could result. Shipping, storage,
and disposal records indicate the ultimate destination of the
substance in question.
Sampling is not generally recommended becauBe of the difficulties
Involved in sampling and analysing a "new" substance. However,
sampling may be indicated in those cases where the Agency is trying
to verify limited environmental or worker exposure. For example, If
the company Is required to manufacture the chemical in a closed
•ystem so that there Is no exposure to workers, and some of the chemical
is discovered on the floor, a sample should be collected. See page 2-13,
"Documentation," for further information on sampling.
Photographs may provide additional evidence* In the above situation,
photographs of the manufacturing process would be helpful. If there Is
a labeling requirement, cake photographs of the labeled product.
Photographs of che shipping, storage and/or disposal areas may also be
uaeful In documenting the circumstances of che violation.
TSCA Inspection Manual
Volume Four: Section 5 Manual
2-16
September 1931
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i..".o3ter .-o
Inspectlo-p Procedures
PKN Withdrawn, .Dcoaplete, ot Review Period Extended or
Suspended; IKE Withdrawn or Denied
Ob ~ec zive
Ensure that the company is not manufacturing the rev substance for
coa^erclal purposes*
Ir.szectio" Procedures
In these cases, any indication that the company has manufactured the
substance for other than R&D purposes is an indlcatl. of a violation
because the company is not permitted to make the new cnemical.
However, if evidence of manufacture is found, the company may claim
that the substance was manufactured for R&D purposes.
Dates
Note dates or the Target Sheet, including the date the Agency
received the PMN or TME, and the dates these were denied, withdrawr,
etc.
Records Review
Ask to see the R&D group leader or manager's files on the chemical
substance. Also check any files the technical contact may have on the
chemical substance.
•	Determine If there is a production process document in any of these
files. (Note the dates on any document.) A production process
document is detailed manufacturing instructions for a chemical as it
moves from bench-scale R&D, through market development, and
ultimately to full commercialization. Process descriptions may be
known by several names, e.g., "Tentative Process" or "Pilot Plant
Process." Examine any and all proceas documents written to cover
synthesis (or production) of the chemical in other than bench-scale
(1-5 liters) equipment. Some process documents, particularly those
that are less formal, may be written on the basis of 100 lbs* of
product or 1—lb. or 1-mole or l-lb.-mole, for ease in making
calculations.
•	Check for any other documents in the R&D file that indicate if and
where manufacture of the chemical for other than R&D purposes was or
is taking place. Note if there are any carbon copy receivers of any
of this information.
If process descriptions or other records indicate that manufacture for
commercial purposes may be taking place, spot check batch (production
records) at the manufacturing site.
TSCA Inspection Manual
VoIum Four: Section 5 Manual
2-17
September 1981
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•	ChecK recoras, starting approximately one montn a::er tne c^ie iiszec
or the process description, or one month prior to the Agencv's
request to manufacture or test market the new chemical. 5pot c".eck
records over a 12-month period.
If batch or R&D records indicate that the substance was manufactured,
then examine sales/shipment/distribution records tnat indicate t-a:
the substance was commercially distributed.
Evidence Collection
If manufacturing for commercial purposes is indi. "ed by records review,
then the nature of the violation Is known—this is a chemical control
violation.
•	Extent of violation, or the amount of the substance Involved. Copy
records that show the amount of the substance produced (or Imported)
and the time period over which this took place. In those cases
where manufacture takes place over a long perloc of time, monthly
summary records, If they exist, may be obtained. Along with the
summary records, note the days on which production took place. If
there is no record of the days on which production took place, it may
be more advisable to subpoena dally records. Consult with the
Regional attorney, who should then contact OPTSE Headquarters
attorneys on the advisability of doing this.
•	Circumstances of Violation. Copy records tha	the ultimate
destination of the substance.
•	Sampling 16 not generally recommended. If, however, records Indicate
by a code or trade name that a batch is the PHN or THE substance and
the company denies that this is the case, a sample may be needed.
Samples should only be taken when records or statements are not
sufficient to establish the manufacture of the substance. See page
2-13, "Documentation," for further guidance on sampling.
If records Indicate that the substance Is manufactured for a commercial
purpose but the company claims an R&D exemption:
•	Copy all R&D records. Determine if these records are consistent with
prior statements obtained about the company's R&D policy. Discuss
any discrepancy with company officials. Document discrepancies in
field notebooks.
•	Determine from the Target Sheet if the Agency Is concerned because
the chemical poses a health risk. Under Section 5(h)(3) of TSCA,
the employer Is required to notify employees of any risks associated
with a chemical. The manner In which the companies are to do this is
discussed in the proposed regulations and, therefore, doe6 not become
m requirement until the regulations become final. Nevertheless, the
employer should be questioned about this. Ask company officials what
types of employees handle the substance, and if special guidance has
been given employees to avoid risks to health from handling the
chemicals.
TSCA Inspection Hanual
Volume Tour: Section 5 Hanual
2-18
September 1981
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Chapter Two
Inspection Procedures
Section 5(e), 5(f) Orders, Rules Or Injunctions
Ob iect1ve
Determine If the company Is In compliance with the restrictions
outlined In the Section 5(e) or (f) order, rule, or Injunction.
Inspection Procedures	
Dates
Note dates on the Target Sheet, specifically, the date the Agency
received the PMN and the effective date of the order, rule, or
Injunction.
Restrictions
An action under Section 5(e) or (f) can prohibit or limit the
manufacturing, processing, distribution In connerce, use, or disposal
of a new chemical. Therefore, the first 6tep Is to determine from
the Target Sheet which activities are prohibited or limited.
The categories of restriction and the types of records to examine are
similar to those outlined on pages, 2-15 under "THE Granted With
Restrictions."
Records Revie^
Examine records to verify that prohibited activities did not take
place and/or that restricted activities took place within appropriate
limits. Review records, starting approximately one month prior to
the Agency's receipt of the PMN. Spot check records over a 12 month
period.
Evidence Collection
If the company has exceeded the limits of a restriction or performed
a banned activity, copy records that document this and that can be
used by case preparation officers In calculating the penalty.
Specifically, determine:
•	Nature of violation, that Is, did the company fall to keep required
records, did they exceed restrictions placed on the chemical
substance including production, use, or distribution limits, or did
they fall to submit all data in their possession on the chemical
substance.
•	Extent of violation, or the amount of substance involved. Copy
records that show the total amount of the substance produced (or
2-19
September 19B1
-------
Izocrted) and tne :i-e period over t-i;- r-ls	-.ate. I- :-:st
cases vnera manufacture Cakes place over a long, 967101; of ti.ft.ei
monthly summary records, if they exist, may be obtained. Along v: ti-
the summary records, note the days or which production too* place.
IE there is no record of the davs of which prod^cticr too'1-, place, ::
may be more advisable to subpoena daily records. Consult vitn the
Regional attorney, who should then contact OPTSE Headquarters
attorneys on the advisability of doing this.
•	Circumstances of Violation. Copy records that indicate the ultimate
aestination/ena use of tne substance.
« Sampllng Is not generally recommended. However, in the case of a
disposal requirement there may be a need to sac?le. For exacple, ::
the Agency action requires that there be no discharge of tne
substance and the inspector has reason to believe that this Is not
the case, a sample of the effluent should be obtained. See page 2-13,
"Documentation," for further information on sampling.
•	Photographs. Pictures taken of the manufacturing, packing, shipping,
storage and/or disposal areas may also be useful in documenting tne
extent and circumstances of the violation.
TSCA Inspection Manual
VoIum Four: Section 5 Manual
2-20
September 196.
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Cioslre Co-fererce
Follow the procedures for closing conference as outlined ir. Chapter 3-5 of
the TSCA Manual.
•	Summarize findings briefly. Be careful not to offer conclusio~s
as to possible enforcement actions or other possible violations.
State that final determination of violations and consecuer\ces -ill
be made by other individuals in the Region or headquarters.
•	Summarize all documents listed on "Receipt for Sacpies and
Documents."
•	Summarize all data not available during the inspection that the
company has agreed to provide. Agree on a timeframe for the
submission of the information. Summarize all records or other
inspection data that has been claimed confidential. (See Appendix
2, "Closing Conference.")
•	Answer questions and provide outreach information.
Inspectlor Report
Follow the procedures for preparing inspection reports as outlined in Chapter
*•-1 of the TSCA Manual.
Report Contents
• Report should reference the reason for the inspection.
•	Report should contain information regarding normal compliance
checks made during the Inspection.
•	Report should contain all relevant required forms: Notice of
Inspection, Confidentiality Notice, Receipts for Samples and
Documents, Declaration of Confidential Information.
•	Report should reference all accompanying documentation of the
extent, circumstances, economic gains, and culpability relevant to
alleged violations.
•	If confidential business information must be referenced, try to
make the body of the report as complete as possible so that
continual beck-and-forth referencing between report and CBI is
minimized.
•	Attempt to summarize findings as clearly as possible at the end of
the report.
TSCA Inspection Manual
VoIum Four: Section 5 Manual
2-21
September 1961
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Charter Two
Inspection Procedure?.
Report Transmittal
•	A copy of the report and all documentation should be seit to t-e
Sectlori Head, Compliance Konitoxing Section, OPTSE, for revie-.
•	A copy should also be sent to the Regional Erforcemert Divisior
for concurrent review.
•	After a quick review, the Compliance Monitoring Section	will serd
the report to the Case Development and Legal Branch for	action.
(See procedures dated April 16, 1981, "Case Preparation	and
Litigation under Section 5 of TSCA.")
t Reports or data classified as confidential business Information
should be: sent to the Document Control Officer, 0?TS£, in
accordance with the TSCA Confidential Business Inforaatloi
Manual. A transmittal memorandum should be sent to the Compliance
Monitoring Section notifying them of the availability of the
report.
TSCA Inspection Manual
VoIum Four: Sactioa S Manual
I'll
September 1931
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Appendix
Page
Concerns
1. Section 5 Inspection Scheme	A-l
2. Recommended Security Procedures for Enforcement
Personnel Responsible for Handling Section 5
Information Memorandum:	A-3
Authorization Request for Communication of
TSCA Section 5 Confidential Business
Information Over the Telephone	A-1 3
Toxic Substances Control Act Confidential
Business Information	A—15
3. Section 5 Target Sheet	A-17
U. Section 8(b) Inspection Procedures	A-19
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Appendix I
SECTION 5 INSPECTION SCHEME
A.	Non-compliance with Orders, Rules or Injunctions
1. Companies Subject to Such Action
B.	Failure to Notify
1.	Tip/Complaints
2.	PMN Withdrawn
3.	TME Withdrawn
U.	TME Denied
5.	PMN Incomplete and Not Followed by a Valid PMN
6.	PMN Review Period Extended or Suspended
7.	SNUR Initiated
C.	Non-compliance with Test Market log Exemption
1.	Tip/Complaint
2.	TME Granted with Restrictions and Not Followed by a Valid PMN
D.	Violation of R & D Automatic Exemption
E.	Failure to Provide Information required by TSCA; Reporting
of False or Misleading Information
1.	Tip/Complaint
2.	Firms/Chemicals Suggested by Notice Manager
F.	Use	of Illegally Produced Substance
1.	Tip/Complaint
2.	Customer of Firm Suspected of Violating PMN Requirements
TSCA Inspection Manual
Voluae Four: Section 5 Manual
A-l
September 1981
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jcaeae
TSCA Inspection Manual	A-2	September 1981
VoldM Pour: S*ctloB 5 Manual
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Appendix 2
Recommended Procedures for Enforcement Personnel Responsible for Handing
Section 5 Confidential Business Information
1n?rOD'J^!$n
A great deal of information on new chemicals is considered sensitive t>y the
chemical industry. Consequently, much of the information submitted to the
agency under the Section 5 program -- Including information m premanufacture
notices and test marketing exemption applications -- 1s claimed TSCA Confidential
Business Information (CBI). Because of the large volume of TSCA C6I wnicn will
be transferred and handled while conducting the Section 5 enforcement program,
special procedures have been developed to supplement the procedures in the EPA
TSCA CBI Security Manual and the ~~.Zb 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 5 information.
BACKGRQ'JSD
Unlike other TSCA inspection programs (particularly PCBs), the information
used to target Section 5 inspections and the information that is obtained
during the inspection will most likely be CBI. Section 5 premanufacture
notification (PMN) forms and test marketing exemption (TME) 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 0C0 in PTSE3 directly to tne
0C0 in each region. Under separate cover, a non-CBI memorandum will notify
the person responsible for TSCA inspections in each region that a PMN/TME
Inspection package was sent to the DCO.
Initial coordination among the DCO, the Inspectors and other reviewers of
Section 5 CBI documents in the region 1s a major part of the inspection
program. The DCD and the regional inspection coordinators shojld prepare
an outline describing how the entire program will work, Including organization
of a uniform Section 5 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 inspection.
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 procedures
as well as the Interim Inspection Guidance prepared by PTSED, mjst be followed
carefully during the Section 5 inspection program.
TSCA Inspection Manual
Voluae Four: Section 5 Manual
A-3
September 1981
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A^pg'.C.X .
Security Procedures
REG 1AL PRDCiD'.^iS FOR HANDLING SECTION 5 CB;
MAILING OF t>MN DCT& F30M PT5-D
•	PTSED Compliance Morr.toring Section will oversee the mailing of PM'.
inspection targeting packages to each region. The package will ccns-.«:
of a summary Target Sheet and any other pertinent support documents.
In most cases this information will be confidential.
•	PTSED's DCO will mail all CBI related to the Inspection targeting package
directly to the regional DCO. A non-CBI letter of receipt will be incluiec
in eacn package for immediate review, signature, and return by the DCO.
•	A non-CBI memorandum will be sent under separate cover to the region's
Section 5 inspection coordinator notifying him or	¦-*. CB I data was
sent.
•	PTSED DCO will notify each regional DCO by phone when the CBI is to be
mailed.
RECEIPT OF PMN DATA FROM PTSED
The Regional Document Control Officer/Assistant must:
•	Review each CBI package received from PTSED to ensi-ri that the document
control numbers and number of pages match up as mrcated in the letter
of receipt. If there Is a discrepancy, notify trie PTSED DCO for
clarification.
•	Sign and return the letter of receipt Immediately to the PTSED DCO.
(A return address label will be Included for prompt mailing.)
•	Sign all document cover sheets and fill 1n the date.
t 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.)
•	Participate 1n the pre-rev1ew meeting [see below: Pre-Inspection
Activities - Pre-Review 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:
•	Become familiar with proposed regulations, interim policy statements and
enforcement policies under Section 5, including the types of informa-
tion that may be submitted and collected as CBI during inspections.
TSCA Inspection Manual
VoIum Poor: Section 5 Manual
Sepcember 1961
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Appendix 2
Security Procedures
•	Become faimliar with security practices of each individual reviewer and
establisn working procedures for each person cased on this knowleage.
•	Reauest to be informed prior to any inspection activity of the persons
that will be involved in each individually targeted inspection and/or
review of a Section 5 CBI company file (inspectors, attorneys, Branch
Chiefs, etc.). Also reauest to be Informed of any major changes
in program operation and/or program personnel in the event tha:
Section 5 CBI procedures may be affected.
• Keep duplication of CBI to the bare minimum. The security manual states
that the original should remain with the DCO. However, since the 0C0
will not receive the original, unless regional practice strictly prohibits
it, the DCO's copy can be logged out without duplication. Also, the
transfer of CBI documents among authorized persons in 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 Divisiors,
it 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 1n direct control of the chain-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 5 Target Sheet (summary sheet of conpany)
and attachments, Including the PMN and TME forms and communications between the
company and OPTS. Following are activities to be carried out by the inspectors.
Pre-Revlew Meetings
•	Conduct pre-rev1ew meetings	upoi receipt of all target information from
PTSED. Participants 1n the	meeting should Include Inspectors, DCO/DCA,
attorneys, secretaries who will type CBI, and all other persons who will
review or receive CBI. The	meeting should include discussions of the
Individual responsibilities	of persons involved 1n the Section 5 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 CBI briefing by DCO/DCA; and
-	schedule for similar review meetings.
TC r & Tneno^f <	Manual
A-S
SeDtemher ]9fll
-------
Securltv Procedures
Rev, ew * C51 Room
•	Request access to the CSI ~oformation fron tne DCO/DCA. Be sjre to si:" tie
document cover sheet of each document reviewed. Because of tne sens-,:;v.:y
of the PMN information, the information should be reviewed in tne DC?
room or a room assigned for C5I reviews. Bring necessary regulafons,
guidances, and notepads for the review.
Siqnout of CSI Docunents
•	When it is impractical for review of the information in the DCO roor, tne
documents may need to be logged out. Persons without approved storage must
return the information to the DCO by close of business each day. Personl
with approvea storage can log information out overnight.
In either situation, the following supplemental procedures and precautions
should be followed:
-	Sign cover sheet and the DCO/DCA log out/sign out sheet. (Tms log sneet
is maintained on file until the document 1s returned.)
-	Obtain a current list of authorized persons from the DCO to ensure
that CBI data is shown only to other authorized personnel.
-	When the Section 5 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 in an approved storage
where more than one other person has the combination or where other
categories of CBI is filed, some type of Identification should be
present on the folder or envelope to flag the contents. 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 d1rect security
control can be exercised over the document when it 1s out of the file.
-	Lock the document in the approved storage area when it 1s not actually
being reviewed.
-	Discuss CBI only with or 1n the presence of authorized persons.
-	Discuss PMN Information with an authorized person only 1f there
1s an absolute need to know.
Review of CBI by Others
•	After logging out a document frcr the DCO/DCA, 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 Manual
VoIum Four; Section 5 lUniul
A-6
September 1981
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topeidIx 2
Security Procedures
-	Do not allow other persons to leave the roor wun the C3' tfocu^'i
unless absolutely necessary. If the person must ta*e :*_•
-	Have that person sign a loan receipt which constitutes a record that tne
document is temporarily the responsibility of another Dersoi. (EveT
if a person will not keep tne document overnignt, a loan re:ei:t nus*.
be signed when the document will be out of the direct surveillance of
the person who logged it out.)
-	Give a copy of the loan receipt to the DCO.
-	Be sure that that the person is familiar with the supplemental review
procedures under Section 5.
•	Provide the DCO with all generated CBI notes to be stamped and logged
into tne system.
Discussion of CBI on the Telephone
A blanket waiver has been approved to allow discussions of Section 5 CBI
by telephone. A copy is attached as Appendix 2-A. Although this waiver
has been granted, certain steps must be followed for discusssions between
EPA personnel:
•	Identify at the beginning of the conversation that information about to
be discussed is CBI. This will allow the other party to properly document
the conversation.
•	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 if confidential information needs to be taken on the inspection.
As a security measure, the inspector should take the minimum amount of
31 on travel. The Section 5 Target Sheet 1s designed to gi ve 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, It 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 document(s) that have been logged out and will not be taken on the
Inspection to the DCO before leaving.
If the Inspector needs to take CBI on an Inspection, adhere to the following
procedures:
•	Do not pack CBI 1n luggage that will be checked in at airport, train
station, etc.
•	Oo not leave information in the briefcase or envelope unattended in the
TSCA Inspection Manual
Voltae four: Section S Manual
September 1981
-------
hotel rooT,. Information can be secured 'i a locked bne*;dse, i- the
trunK of a car. However, hotel safes are preferred for ove^'snt store:e.
« Do not carry CSI in a clearly marked "CBI" envelope in the event that tie
briefcase is opened and the envelope is exposed. Briefcases containing C5'
can be carried into a restaurant. Do not, however, review or crscuss t^e
C£I in a public place. Information can be reviewed in tne privacy of a
hotel room when necessary.
Documents anj Equipment
Assemble other appropriate CBI related forms and materials for the inspection,
1ncluding:
-	inspection credentials
-	letter of authorization to access CBI
-	TSCA Inspection Confidentiality Notice
-	chain of custody records
-	loose leaf note paa specifically for CBI notes
-	envelopes adcressed to OCQ (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 in the TSCA Inspection Base Manual
-	CBI stamp and ink pad (if available)
NOTIFICATION OF C0M=)AMr
In general, the Inspector will telephone the company 1n 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. A-. 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 tie discussed with company officials as well as notice managers in OPTS
headquarters. The following procedure should be followed when notifying the
technical contact.
•	Immediately upon phoning the technical contact, request permission to
discuss CBI over the telephone.
•	Give PMN number and date of submittal and/or the generic chemical name
if PMN number 1s not familiar to the technical contact.
•	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 is a security measure which will limit
the amount of CBI information which inspectors will need to carry.
TSCA Iaspectlon Manual
Voluae Four: Sectloo S Manual
A-8
September 1961
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Secj'itv ^^ocedures
•	Ask 1 * 7 h r kc'* *.7 7 1 ; " ~ r - + ' • — = 7 " D " t11 e . - z 7 ' 0 . '.Z~Z d - " 2
tne en s:-ss:o- as cor*ii: ¦ .
•	Fill out te^ec^o'c 1c; cf tie conversation. (Tus Tog "s cons-rered
con* • re":" i" .!
If tne tecnn-.ca1 :Dr.".a:t does "c: c - a n: per—ssic". 13 d-scuss C BI over the
telephone, e x pa" r why it is r,e:essar/ to do sc , ric«.ing the following points
-	lnspe::ior needs t: De scied.le:,
-	Documents c 15*"t™	fe f1—^ cc^la ?e mar? available at the
inspect ".o- site t: a.::r tre nee. fer E:A to travel with such
i nfor-;ti g" ,
-	Ensure that the Iccj-io- o* the site to De inspected maintains the
neeae: recorcs or fist apprcp-ie:: rewOrcs are transferred to the
inspection site, an;
-	Ens--e th3: a cor,;an. o"-ci5'! a.".-.on zed to make confidentiality
clans is a •. 31"! = ~1 e c.vr: :~e inspection.
If after explanation c* n?ed to d's:_s? CE>I,	request is still not granted,
the inspects- sno^r rev/. :rcr Co-:l*.a->:e	v?ritcrmg Coordinator in
Headquarters, Co-o'iance M:mt:-ir: Bra-cn.	(Tne inspector may have to subrit
questlons in wri:irc.,
ENTRY
The inspector should, ir. a::.*, ic. :: o:r,er required inspection procedures,
remember to*
•	Have letter of ajthorization to access CBI readily available. (Letter
should not be copiec or lee^e tne signt of the inspector.)
OPENING CONFERENCE
The inspector should cleanly expla'n how E"A handles and documents information
claimed C5I (A handout is attached for your use in Appendix 2-B). It is to the
company's advantage to clearly and directly make confidentiality claims during
the inspection so that those notes/documents can be 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 procedure
will also make the closing conference and declaration of confidentiality process
go smoothly, effectively and more securely.)
The official at this point also has the opportunity to withdraw any previous
claims of confidentiality for information that has already been submitted to
EPA. The company must submit a letter, waiving confidentiality claim, to the
OPTS DCO 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 is recommended that
such documents be avoided unless they are essential to the documentation
of violations. The inspector should:
TSCA Inspection Manual
Voluae Four: Section 5 Manual
A-9
September 1981
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Appendix 2
Security Procedures
•	Clearly mark or stamp immediately each document claimeo CE1 djr-.^c tne
inspection. Place documents inside an envelooe also marnec 'corf:cert•a!
business information to be opened by addressee only." Tnis envelope
should be placed inside a plain envelope and mailed immediately oy
-eaiste^ed mail to the Document Control Officer in the regional office
^r'ter tne inspection when hand delivery is not possible.
•	Informal ion clamed or suspected to be claimed confidential (either
orally or copied) obtained from facility records, should be referencec
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 CI'.
documents. Photocopied documents should be referenced in the same manner.
•	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 moved to another area.
It is recommended that instant cameras which do not produce negatives
be used.
CLOSING CONFERENCE
The inspector must, in addition to other required inspection procedures:
t 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 tnis list
carefully with the company representative.
•	Prepare a complete 11st of all items declared CBI on the Declaration of
TSCA CBI form. Facility officials must review and make any further enfies
on the Declaration form.
•	Mail CBI documents by registered mail from a post office immediately to
the DCO when hand delivery is 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	Sepcenber 1981
Voluae Four: Section 5 Manual
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.	.				aecurirv rroceaures
m:scellaneoj5 R:*:n:e3S
•	No pnvate contractor assistance 1s available under the Section 5
Inspection Program.
•	Only DCOs/DCAs can make copies of CBI. However, the regional DCO
is not to duplicate Section 5 CBI for distribution to anotner
region. Contact the PTSED HQ 1n cases when Section CBI needs to
be sent to additional regions.
•	Inspectors must contact the HQ Compliance Monitoring Coordinator if
they want to challenge a company's confidentiality claims.
Declassification under Section 5 has not been redelagated to the
regional counsel, therefore coordlnitlon must be JMde through HQ.
•	Ask the DCO/DCA for any further Information on CBI procedures.
Violators of the security procedures by wrongful disclosure of CBI are
subject to criminal penalty under TSCA Section 14(d) 15 U.S.C. Section
2613(d).
TSCA Inspection Manual
Voluae Four: Section 5 Manual
A-l 1
September 1981
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Appendix 2
Security Procedures
TSCA Inspection Manual	A-12	September 1981
VoluM Four: S«ction 5 Kuual
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Appendix 2-A	Security Procedures
* ** \
iss.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

?	WASHINGTON, D C 20460
-U. 20 1931
r r r ic Z or
^CSTICIOCS AND TOKlC IUDS'as: cs
MEMORANDUM
SUBJECT: Authorization Request for Communication of TSCA
Section 5 Confidential Business Information over the
Telepfione
TO:
FROtf:
Ed Cull, Chief
Information Services Branch
Management Division
LrLoJ.
John S. Seitz , Chief
Compliance Monitoring Branch n	^
Pesticides and Toxic Substances Enforcement Division
The majority of information submitted to the agency under
Section 5, including Prenanufacture Notices (PMN) and Test Marketing
Exemption (TME) has bean claimeo Confidential Business Information
(CBI). As such, this is the first TSCA enforcement program which
will require the handling of large volumes of CBI.
PTSED is currently coordinating with OPTS to target the first
group of companies for Inspection under the Section 5 inspection
program. These target Inspection packages will be transmitted to
the regions for review, coordination and implementation. Prior to
each inspection, the region will need to contact the facility to
ensure that appropriate officials and records will be available at
the designated site. Also, the regions on occassion will need to
contact HQ to gather additional Information or to ask questions.
In both Instances, the authorization to discuss CBI over the
telephone would facilitate coordination efforts and expedite the
transmitting of facts and information among authorized agency per*
sonnel and company personnel submitting the Information.
The communication would Involve:
Region
to
Region
Region
to
OPTS
OPTS
to
R e g1 on
PTSED
to
Region
Region
to
PTSED
PTSED/Regi on
i to Company
TSCA Inspection Manual
Volt Four: Section 5 Manual
A-13
September 1981
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Appendix 2-A
Security Procedures
Upon approval of the authorization, the following procec.'*e
wouId be fo 11 owed:
EPA employees authorized for access may, wher> necessary,
discuss TSCA Confidential Business Information related to this
Section 5 inspection program over the telephone with other
authorized E ? A employees or the representative of t^-e firr;
submitted the Information. Any such information discusser; woulj'
first be specifically identified es TSCA Confidential 3jsih?ss
Information during the conversation.

Disapproved
o f. t o
TSCA Inspection Manual
V«1um Four: Section 5 Manual
A-14
September 1981
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Appendix 2-B
Security Procedures
Fact Sheet
TSCA Inspection Confidentiality
Rig nt to ^laice Confidential Business Information Claims	
Section 14 of the Toxic Substances Control Act (15 USC Sec. 2613) permits aiv ma-,.-
facturer, processors, or distributor in commerce of chemical substances to cla.- a;
confidential business information (CBI) any information submitted under the Ac: t:
the U.S. Environmental Protection Agency (£Pa). EPA regulations at 40 CFK Pare I
require that businesses be notified of this right when EPa requests or de=a"ds
mation which might be entitled to confidential treatment; the regulations alsc aeta.l
the notice and hearing procedures to be followed if a public request is mace for sj:~
information.
Section and the regulations are designed to protect confidential business mfcrea-
tion from unauthorned disclosure. Confidential business information includes infor-
mation considered to be trade secrets (including chemical identity, process, formula-
tion, or production data) that could damage a company's competitive position if it
became publicly known.
Information collected during an inspection would be made available in response to a
Freedom of Information Act (FOlA) request unless the information were determined to
be exempt from release under strict FOIA criteria. However, if the data has beer,
claimed confidential business information by the company, EPA would follow certain
procedural steps prior to release of the information and the cata would no: be
released at all if it was determined to be entitled to confidential treatment.
TSCA Inspection Confidentiality Notice	
The TSCA Inspection Confidentiality Notice is the company's official notification of
the right to nuke confidentiality claims for material collected during a TSCA inspec-
tion. It lists four criteria which oust be met by any information the company claims
confidential. The Notice should be signed by the facility owner or agent in charge
at the time of the inspection to acknowledge receipt.
If no facility official i6 present at the inspection site who is authorized to make
CB1 claims, the Notice and accompanying forms (tee below) will be sent within two
days of the inspection to the Chief Executive Officer of the firm and another company
official, if designated. In such instances, CBI claims can be made by the company
within seven days of receipt of the Notice.
How CBI Claims Are Made
Information is officially claimed CBI at the cloae of the inspection. However, it is
strongly suggested that, when available on-site, a company official authorized to
make CBI claims accompany the inspector during the inspection to facilitate designa-
tion of confidential business data while the inspection is in progress; this official
can also help the inspector avoid copying confidential information not necessary to
the purpose of the inspection.
At the end of the inspection, the inspector will hold a closing conference with
facility officials. At this time, all documents, photographs, or physical samples
taken during the inspection will be listed in detail on a Receipt for Documents and
Samples.
TSCA Inspection Manual
Volume Pour: Section 5 Manual
A-15
September 1981
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iecuncv rrocejure*
The authorized company official should carefully review cms list and decide wr, ic- z:
the items should receive confidential treatment. Each iter. Co be claimed confi-
dential muse meet all of the following criteria
•	The company has taken measures to protect the confidentiality of the 1-
formation and it intends to continue to take such measures,
•	The information is not, and has not been reasonably obtainable withou:
the company'6 consent by other persons (other than governmental bodies/
by use of legitimate means (other than discovery based on a shov.-'g of
special need in a judicial or quasi-judiclal proceeding);
•	The information is not publicly available elsewhere; and
•	Disclosure of the information would cause substantial harm to the
company's competitive position.
;uch items should be listed on the Declaration of TSCA Confidential Business Informa-
tion form and the facility official must sign the form certifying that each itez
meets the criteria.
If no authorized facility official is on-site during the inspection, the Notice,
Receipt for Documents and Samples, and Declaration form will be 6ent by registered
mail to the Chief Executive Officer (and other designated person) within two days o
the inspection. C5I claims in such caseB may be made by the company within seven
days by registered mail.
Security Measures for Handling CBI		
Any information claimed CBI if handled under stringent security procedures. The do
uoent control system for CBI includes logging of all information, secure physical
storage of the material, and access only by authorised personnel who have undergon.
security clearance procedure and have a need to know. Personnel given access to CE
are strictly accountable for any CBI in their posaeasion. These procedures are de-
tailed in the TSCA-CBI Security Manual. TSCA Section 14 provides a criminal penalty
for wrongful disclosure of confidential business information, whether such disclosu1
is made by an EPA employee or employee under contract with EPA.
Data not imnediately claimed confidential business information because no authorized
person is available on-site during the inspection will be kept in locked storage am
otherwise accorded confidential treatment. However, the material will not be enteri
into the document control system until an actual CBI claim is made (within the
seven-day period).
Release of CBI
When EPA desires or needs to determine whether information claimed confidential is
entitled to confidential treatment (such as if there is an FOIA request), the Agenc
will furnish the affected business an opportunity to substantiate its claim in accoi
dance with 40 CFR §2. If a determination is made that information claimed confidfi
tial under TSCA is not entitled to confidential treatment, EPA will notify the
affected business that it will release the information on the thirty-first calends,
day after its receipt of the notice, unless the business first notifies EPA's legs*
office that it has commenced a lawsuit to prevent disclosure of the information.
TSCA Inspection Manual
Voluae Four: Section 5 Manual
A-16
September
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Appendix 3
SECTION 5 TARGET SHITT
{place all CBI information jn brackets]
REGTONU)
TME #
PHN
PARENT COM?ANT
address:
DISPOSITION':
DATES:
t echn i cal
cont ac t:
phone,
INDUSTRIAL SITE(S):
CHEMICAL NAME: Generic-
Spec i f ic-
Trade-
I'SE-
RESTRICTIONS (if TMEs)/SPEClAL CONCERNS:
SUPPLEMENTARY INFORMATION:
Notice Manager:
~~Indicates company location uhich submitted PMN or applied for TME
TSCA Inspection Manual	A-17	September 1981
VoIum Pout: Section S Manual
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Appendix 3
Targe: Sheet
TSCA Inspection Manual	"	Arl§	September 1981
Voluae Fout: Section 5 Mutual
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Regulatory Requirements
Inspection ?roce;_7es
Reporting Substances Excluded fron Investor'.
Research and Development Substances
Regulation Reference 40 CFR 1710
Any chemical 6ubstance manufactured,
processed, or imported 6olely in
small quantities for research and
development as defined in §710.2(y)
is excluded from the inventory.
(5710.4(c)(3)
Determine company criteria for
chemical substance to be classified
for R6D use. Copy criteria. If
unavailable, obtain statement froc
responsible official outlining
criteria.
Determine specific procedures for
development of test marketing
program for an R&D substance. Copy
procedures. If unavailable, obtair.
statement from responsible official
outlining procedures.
Section 710.2(y) defines small
quantities for research and develop-
ment as:
• Quantities of a substance no
greater than reasonably necessary
for purposes of:
•	Scientific experimentation on;
•	Analysis on;
•	Chemir.al research on;
•	Analys is of;
•	Any research or analysis for the
development of a product.
These quantities must be used by or
directly under the supervision of a
techically qualified individual.
• Determine educational background
and present professional duties
of any person in charge of the
use or distribution of che
substance.
TSCA Inspection Manual
Volume Four: Section 5 Manual
A-19
September 1981
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Regulatory Requireme_ts
Inspection Procedures
The regulations note:
There Is a presumption that products
manufactured, imported or processed
In quantities of les6 than 1000 lbs.
are for R&D purposes.
A person reporting a substance
produced In 6uch quantities has the
burden or certifying chat it is not
for R&D.
t Obtain a statement fror a
responsible company official as j
well as the person in charge of
the use or distribution of the
substance attesting to tha:
w	j
person's education and	j
professional responsibilities. I
i
Obtain and copy:	|
•	Company documentation in support
of non-R&D classifications for
particular chemical substance.
•	Production records for the first
year.
•	Sales records for the first year i
•ales took place.
•	Records listing names, addresses
and phone numbers of buyers for
later verification of quantity
and use by buyer.
•	Customer correspondence
demonstrating coomerical
distribution or test marketing
phase.
•	Records indicating size and
number of production 6ite(s).
•	Records indicating Internal use
to which chemical is put if not
•old.
• Advertisements regarding use of
Che substances.
Note: If records or advertisements
unavailable, make notation to chat
effecc in the field notebook.
TSCA Inspection Manual
Volume Four: Section 5 Manual
A-20
September 1981
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Aooendix i
Regulatory Requirements 	
Reporting Substances Excluded
Manufactured, Processed, or
Regulation Re
Any chemical substance not
manufactured, processed or imported
for a commercial purpose since
January 1, 1975 is excluded from the
inventorv.
	 Inventory Inspection Procedures
	 Inspection Procedures 	
i
i
from Inventory: Substances Vet
mported Since Jaruarv 11, 197 5
j
:ereocc 1710.A
I
I
I
Obtain and copy:
• Production records or (for
importers) purchase records fro=
1975-1961.
• Sale6 records from 1975-1981.
•	Records listing buyers from
1975-1981. (Names, addresses,
telephone numbers for
verification of year and amount
of sale.)
•	Records of use if not sold.
•	Statement certifying internal
use from company official.
• Advertisements regarding sale or
use from 1975-1981.
Note: If records or advertisements
are not available make a notation
to that effect in field notebook.
TSCA Inspection Manual	A-21
VoIum Four: Section 5 Ma nut 1
September 1981
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Apterdix 	 _____	Investor? Inspection Procedure';
Regulatory Requirements
Inspection Proceci:res
Reporting Substances Excluded From the Inver.torv
Chemical Substances Rejulated Under Other Acts
Regulation Reference $710.4(c)(1)
Any substance not considered a
"chemical substance" as provided In
subsection 3(2)B of TSCA and In the
definition of "chemical substances"
in 4710.2(h) is excluded from the
inventory.
A "checical substance'
include:
does not
•	Any pesticide when manufactured,
processed or distributed in
commerce as a pesticide.
•	Tobacco or any tobacco product,
but not Including any derivative
products.
•	Any source material, special
nuclear material, or byproduct
material.
•	Any food, food additive, drug,
cosmetic, or device, when
manufactured, processed, or
distributed in cooserce for use as
a food, food additive, drug,
cosmetic or device*
Copy records substantiating a use
that does not fall into the
excluded use of the substance.
Copy records. Obtain statement
certifying use from responsible
company official.
Copy advertisements regarding the
non-excluded use of substance.
Copy records listing buyers i^ho use j
the substance for a non-excluded i
purpose, and correspondence	'
demonstrating use by buyer for
Tjon-excluded purpose.
Copy addresses and phone nu"1"
of buyers for later ve
of con-excluded use.
Copy sales records for non-excluded
uses as veil as excluded uses.
Note: If records	or advert israents
are not available	make a notation
to that effect in the field
notebook.
TSCA Inspection Manual	A-22
Voluae Four: Section 5 Manual
September i981
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APPENDIX F
EPA HQ § 8(a) LEVEL A GUIDELINES
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THE TSCA 5R(a} PRELIMINARY ASSESSMENT INFORMATION RULE
INSPECTION GUIOELINES
OVERVIEW
Background
On June 22, 1982, the Environrental Protection Agency (EPA) published In
the Federal Register the TSCA §3(a) Preliminary Assessment Information
rule. The rule requires manufacturers, Including miners and Importers, of 250
chemicals listed 1n §712.30, to provide the Agency with general production,
uses and potential exposure information. The 250 chemicals were designated by
the Interagency Testing Committee (ITC) and Includes 33 chemicals for which a
§8(e) submission was received. This information will be used by EPA 1n setting
priorities for testing chemicals and assessing risks of human and environmental
exposure associated with chemicals.
The Office of Toxic Substances (OTS) has sent out Preliminary Assessment
Information packages to manufacturers identified on the Inventory as producing
any of the 250 designated chemicals and manufacturers who have requested the
packages.
In Section 10 of the preliminary assessment information form, manufacturers
are required to estimate customers' uses of the chemicals. As a follow-up to
this reporting, EPA has proposed a rule to require processors to report
information on each chemical for which manufacturers indicated unknot customer
uses for more than 20% of the total quantity manufactured.
Objective of the TSCA $8(a) Inspection
The objective of the TSCA §8(a) Level A Inspection 1s to ensure that all
manufacturers currently manufacturing any of the 250 designated chemicals
have submitted complete and correct data.
Selection of Companies
The TSCA §8(a) inspection will be conducted by regional EPA Inspectors.
Inspection targets will be derived from the companies subject to §8(a) that
have been Identified from the Inventory by OTS and companies that have requested
§8(a) Information. Companies will be randomly selected for Inspection by PTSEO
1n accordance with the Nautral Administrative Inspection Scheme (NAIS), targeted
from referrals by OTS and tips or complaints.
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Reporting Rule Requfremerts
Manufacturers and Importers Required to Report
All manufacturers who produce or Import any of the 2S0 listed chemicals
in §712.30, or in the case of miners and oil refiners, apply any method of
extraction, refinement or purification of the mined substance to make it
marketable, are required to report. This does not include importers of articles.
A Preliminary Assessment form must be filed for each chemical substance listed
that is manufactured or imported.
Reporting Period
The information to be submitted for a given substance or mixture
must cover the respondent's latest complete corporate fiscal year as of
July 22, 1982, (See Appendix II, Question 5). The companies have four months
from the effective date to submit complete reports.
Data Requirement
To aid in assessing risks in production, disposal, and use of certain
chemicals, the following information 1s required of manufacturers.
0 Quantity of chemical manufactured;
0 Amounts Hirni-ta/T_>r.	of USeS ;
° Potential environmental and worker exposures; and
° Environmental releases associated with the manufacturer and
immediate customers processing of the chemicals.
Recordkeeping
There is no recordkeeping requirement for this rule.
Exemptions
In the case of the following exemptions, a company would not be required
to submit a report:
0 Chemicals produced in amouits less than 500 kg. annually (Small
Quantity Exemption);
0 Chemicals produced at sites manufacturing less than 100,000 lbs. of
the chemical and the parent company's sales are less than $300,000
(Small Business Exemption};
-2-
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* Substances manufactured as intermediates and consumed in cheirncal
reactions used for th
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Chapter Two
PRE INSPECTION ACTIVITIES
Confidentiality	
Because of the confidential nature of many industry submissions, almost
all TSCA §8(a) Level A information vrl 11 be handled as CBI. Proper precautions
should be practiced In preparing for the inspection. For a discussion
of the specific procedures to follow, refer to Appendix 2-8 of tolume
Four: Section 5 Inspection Manual of the TSCA Inspection Manual.
Targeting Inspections
Inspections will be conducted to verify data, investigate complaints
and investigate 0T5 referrals. Before the Compliance Monitoring Section
forwards the targets to the regions, the Industry Assistance Office {I AO)
will be contacted to determine the site of the inspection.
Veri fication
Based on the inventory, a mailing list was compiled by OTS of manu-
facturers which may be subject to Hie fmVer Included.on the list are
companies not on the Inventory that have requested a Preliminary
Assessment package. The package Includes a report form for companies to
submit if they are subject to the rule, and a response card for companies
to notify EPA If they are not subject to the rule, though they are not
required to forward the card if they are not subject to the rule.
From the list, verification inspections will be targeted In accordance
with the NAIS to detect:
0 Companies failing to report, and
° Companies falsifying reports.
Complaints
Several sources, for Instance, employees of manufacturers, competitors,
information gathered during another Inspection, etc., may bring possible
violations to the attention of EPA. These complaints will be reviewed by
OTS and PTSED. If a violation 1s suspected, an Inspection will be targeted.
OTS Referrals
If, during the review of a submission, OTS discovers a possible violation,
the submission will be referred to PTSED for concurrence and referral to the
region.
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Preparation of Documents"
Notices and forms should be prepared as detailed in Chapters 3 and 6
of the TSCA Manual, Volume Oie.
° NOTICE OF INSPECTION For Section 8(a) Level A Inspections, researtn
and production data will be reviewed. Section 11 of TSCA requires
research data and shipping records to be specified on the Notice of
Inspection if ft is to be reviewed during the Inspection. Check off the
second box on the notice and list a summary of the data to be viewed as
the exact records may not be able to be determined before the Inspection.
0 CONFIDENTIAL INFORMATION If a copy of the company's submission will
be taken on the Inspection, ensure that 1t is handled as CBI.
TARGET SHEET The target sheet (Appendix I) will summarize the
background Information of the Inspection site. Since a form must be
completed for each designated chemical produced at each plant site,
only one chemical and one plant site will be listed on a target
sheet. For each company Inspectedt there may be more than one target
sheet.
If the Inspection was targeted by a referral from OTS, the special
concern will be specified on the target sheet. If the inspection ws
Initiated by complaint, and no submission was filed, all Information
available will be Included with the target sheet.
PRELIMINARY ASSESSMENT FORM If the inspection 1s targeted for a company
that filed a submission, a copy of the submission will accompany the
target sheet. In the Inspection Activities section of these guidelines,
sore questions are offered as suggestions for the inspection.
Notification of the Company
Notify the Technical Contact of the company targeted for Inspection before
the Inspection, to ensure that all the documents needed for the review will be
available. Also ensure that proper safety equipment will be available for the
plant site review.
Inspection Safety Equipment
While no sampling will be required, the Inspection will Include a plant site
review of the companies' manufacturing area. Ensure that proper safety equipment
1s available to the inspector.
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Chapter Two
INSPECTION ACTIVITIES
Entry
EPA credentials should be presented and TSCA documentation requirements
followed during the Inspection. Refer to Chapter 3-2 of the TSCA Inspection
Manual, Volume Che, regarding credential presentation and Issuance of Notice of
Inspection, Receipt For Samples and Documents, Notice of Confidentiality, and
Declaration of Confidentiality.
0 Identify the otner, operator or agent 1n charge and present credentials.
0 If submission Is confidential , ensure that TSCA confidential security
procedures are followed.
Denial of Entry
If entry is denied, notlfy the appropriate Regional personnel. If
necessary, the Region may then contact the Office of Legal and Enforcement
Cowsel 's attorneys for guidance. Refer to Chapter 3-2 of the TSCA Manual.
Opening Conference
Follow the procedures for Opening Conference 1n Chapter 3-3 of the
TSCA Inspection Manual , Volume One. After having Identified the owier, operator
or agent 1n charge, the Inspector should discuss the procedures for claiming CBI,
and then discuss the purpose of the TSCA §8(a) Inspection program.
General Discussion
Outline Inspection plans with the facility officials. Discuss specifically
the objectives of the Inspection, Including the substances to be Investigated,
information that will be required, personnel to be involved and the records to
be inspected.
Inquire If the company has any questions concerning the TSCA Section 8(a)
Reporting Rule.
Some companies may manufacture a large volume of chemicals. To efficiently
utilize the time 1n the Inspection while still conducting a thorough Investigation,
select only one or two products for review. Notify the company representative
that only one or two products will be reviewed.

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Inspection Activities
OBJECTIVES
The objectives of the 53(a) reporting rule inspection program are to
ensure that:
0 All the companies subject to the rule submit a Manufacturer's
Preliminary Assessment Information form, and
0 All companies submitting a report Include correct and complete information.
PROCEDURES
The reason for Inspection will be noted on the target sheet. The same
procedures for inspection can be followed 1n all Instances. For companies that
manufacture a large volume of chemicals, select one or two chemicals for the
review.
The following information should be documented during the inspection
concerning manufacturing, importing, uses, worker and environmental exposure,
and customer processing during the company's last corporate fiscal year. The
inspection will include both review of records and observation of the plant
facil ity.
Data Review
Chemical Identification
The form requires only the first 15 characters of the chemical name.
Because of the variety of ways to describe the chemical substances, many
can appear the same in only 15 characters. Verify the CAS number, category
name and document the complete chemical name.
Plant Site Identification
Verify the plant site's Din and Bradstreet number, address, and parent
company.
Preliminary Assessment Information
The following 1s an aid for conducting the verification Inspection.
The first colurm, "Determine", consists of suggested questions that will help
yield information to verify the data submitted. Listed across from the
questions in the "Review" column are data that may contain the information
for answering the questions, teny answers may need to be estimated by the
manufacturer. Also included for assistance 1n Appendix II are questions that
have been asked of IAO by Industry.
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DETERMI N E
REVIEW
PART A (Plant Site Activities)
ITEMS 1-3 Include pxtraction, refinement, and purification of a chemical
° What was the total amount of the
chemical imported7
° How much was manufactured for com-
mercial sale or use?
° How much was sold to customers for
test marketing?
° How was the quantity lost to the envir-
onment in manufacturing determined?
" How was the quantity of wastes
determined?
° Are any amowts of wastes sold or
shipped to another site for eventual
use?
" Invoices
13	Shipping records
° Production schedules
° Annual sales reports
0	Invoices
°	Manufacturing and processing
records
°	Laboratory records
° Inventory records
°	Batch records
Monitoring records
0 How was the chemical disposed of?
° How are	spills cleaned-up and disposed
of?
0 Was the	chemical destroyed in the
process of di sposal ?
Monitoring records
• Storage and disposal records
ITEM 4
The following questions pertain to the types of processes used 1n various
states of manufacttring and workers expos ire during these processes.
Because it is difficult to definitively define enclosed, limited release
and open processes, asking the representative to describe the process, will
give a clearer irderstandlng, Refer to the definitions given In the rule
for a brief description . Inquire 1f the company has a definition for each
process.
0 Describe the procedures followed In
manufacturing the chemical.
° Qual1ty control procedures
for production process
° Is the chemical processed in a partially
enclosed area to limit the chemical
releases? Which parts are enclosed?
° Quality control
procedures
° Does the process utilize any equipment
to monitor worker exposure or environ-
mental release?
° Quality control
procedures
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DETERMINE	REVIEW
0
Is the chemical produced routinely in
direct contact with the environment and
workers without any methods to prevent
release?
0
Ouality control procedures
0
Is there any equipment functioning to
prevent environmental release or
worker exposure?
0
Qua!ity control procedures
0
What types of equipment are used to
prevent or limit environmental release?


0
What are the amoints of the chemical
released?
0
Processing records
e
How are these aroints determined?
0
Monitoring records
o
Where is the air in the processing area
vented?
0
Monitoring records
0
Does the chemical pass through more
than one process? Example: First step
is processed in an enclosed system, in
the next step the chemical is processed
in an open system.
0
Processing records
o
0
What amounts of the chemical are pro-
duced in each operation?
Are any samples taken? How?
0
0
0
Batch records
Processing records
Production records
0
How many employees work in each
process operation? (If an employee
works in several processes, accoufit
for the worker in the processes they
work the most hours)
0
Q
Processing records
Employee records
0
How many hours a year are the processes
operating?
e
Production schedules
0
How many worker-hours are used 1n
processing the chemical?
(This data may not be verifiable but,
with the added information of the
number of workers, 1t will give an In-
dication of the extent of the exposire.)


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determine
REVIEW
' * -
ITEMS 5 i 6

These items concern chemicals manufactured for on-site use. It includes the
use af the chemical as a solvent, emul sf fier t etc. as a reactarit.
0 What quantities of chemical are
processed for on-site use'
° Processing records
0 How is the chemical used?
Processing records
° (toes the chemical alter Its mo7ecu?ar
structure In the process of manufactur-
ing?

" What are the steps the chemical passes
through to reach this reaction?

0 Is the chemical used up in the process-
ing?

° Are any samples taken? How?

0 How is the amount of chemical that
reacts determined?

° Are there any steps which recycle the
unreacted chemical back to the
reactor?

° What Is done vri th the u>reacted
chemical ?

° Is the chemical processed in direct
contact with the environment or
workers?

0 Haw many employees work in processing
the chemical used on-site?
° Processing records
° How many hours a year 1s the process
operating to produce this chemical?
0 Processing records
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DETERMINE
REVIEW
[TEH 7
ITEM 7 should define the preparation of the chemical into a product t.hat is
used on-site or for commercial sale and include all the steps the chemical
passes through to produce the product or article to be used on-site or
sold. (This item DOES NOT include manufacture of the chemical.)
° Is the chemical being processed into
a product for on-site use or
commercial sale?
° What amount of the chemical substance
is incorporated Into a mixture or
article that will be used on-site or
sold commercially?
0 What quantities of the chemical are
processed for on-site use (solvents,
etc.) or sale?
0 Describe the process steps employed In
preparing the chemical for incorporation
Into the article?
0 How many workers -are empT oyed- in these
operations?
® How many hours per year are the pro-
cesses in operation to prepare the
chemical for Incorporation into a
product for on-site use or sale?
ITEM 8
ITEM 8 requires the quantity of chemical that is prepared for commercial
domestic use that the customer WILL NOT further process. (ITEM 9 AND 11
concern the chemical mixture that the customer WILL further process.)
There will be 3 types such of products.
CHEMICALS OR MIXTURES: Those sold in bottles or containers and used directly
by the customer (cleaners, paints, Inks, etc.)
ARTICLES WITH NO RELEASE: Those products where the chemical 1s completely
enclosed (thermometers, batteries,etc.)
Processing records
° Inventory records
° Invoices
0	Annual sales reports
0	Processing records
°	Batch records
° Processing records
°	Processing records
° Batch records
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DETERMINE
REVIEW
ARTICLES WITH ENVIRONMENTAL RELEASE: Those products where the chemical is a
part of the article and can come in contact with the
environment (printed paper, coated applicances, etc.)
0 What quantities of the chemical
0 Production records
substance are manufactured as an end-

product for commercial distribution
0 Annual sales reports
(not going to be further processed by
0 Invoices
the customer)?
° Shipping records
0 How much of this quantity is a chemical
0 Annual sales reports
or mixture for industrial use?
0 Shipping records
0 How much of this amoirt is used in an
° Invoices
article that comes 1n direct contact
° Sales brochures
with persons, the atmosphere, land or

water

Example: A textile where exposure

comes from surface contact.

° How much of this amoirt is used 1n an
" Invoices
article with no environmental release
0 Sales brochures
(completely enclosed, example:

batteries) for industrial use?

0 What amouits produced are a chemical
° Annual sales reports
or mixture containing the chemical for
c Shipping records
consumer's use?
c Invoices
0 What amowts produced for comsumer's
° Annual sales reports
use are incorporated into an article
° Shipping records
having some environmental release?
° Invoices
Example: A coated appliance where
° Sales brochures
exposure comes from surface contact.

° What amounts produced for consumer's
0 Annual sales reports
use are Incorporated Into an article
0 Shipping records
with no environmental release
0 Invoices
(thermometers, batteries, coatings

on internal components, etc.)?

What quantities of the chemical are
° Invoices
produced for export (as a mixture,
° Sales brochures
chemical or article)?

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DETERMINE	REVIEW
CHEMICAL SUBSTANCE PROCESSING BY CUSTOMERS
Though customer processing Information is required to he submitted by the
company, the information may have to be estimated. The following questions
apply only to a chemical substance the customer will further process before
using. ITEM 9 pertains to the types of customers' products and product uses.
ITEM 11 pertains to the processes the customer uses to prepare the chemical
for use or sale.
ITEM 9
0 What quantities of chemical or mixture
are used by the industrial customer?
By the consumer?
° What quantities of the chemical Incor-
porated in an article with some environ-
mental release are used by the Indus-
trial customer? By the consumer?
0 What quantities of the chemical incor-
porated in an article with no environ-
mental release are used .by the
industrial customer? By the consumer?
0 What quantities of the chemical used in
a chemical formulatio_n, mixture, or
article is used by the importer?
0 What amomts of the chemical will be
reformulated, reacted or, in another
way, processed by the customer? By
the importer?
0 What quantities given or sold to the
customer cannot be accomted for?
ITEM 10
If the respondent listed "UNKNOWN" in ITEM 9 for more that 20% of the
chemical manufactured:
0 What are the marketed or trade names of
the chemical , mixtures, or articles?
ITEM 11
Describe the processing operations
employed by the customers for further
preparing the chemical for use or sale.
0 Annual sales reports
0 Invoices
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Documentation
If there are any discrepancies between what was reported and what is found
during the review of records, copy the records indicating the discrepancies and
include it 1n the inspection report with an explanation.
Plant Site Review
OBJECTIVE
The objective of the plant site review is to verify that the chemical is
being manufactured and processed In the process system(s) reported on the submission.
PROCEPURES
Although no sampling will be required, assume that proper safety equipment is
worn before walking through the plant site.
During the plant-site review request the company official to describe the
processes the chemical passes through before 11 Is used on .site or sold. Some
areas to take note of are:
°	Are the vats containing the chemical closed?
0	How are they sealed?
°	Where 1s the air being vented to?
•	Is there any monitoring of the air?
0	How many employees are working In the manufacturing and processing areas?
0 Are employees 1n direct contact with the chemical at any time during the
processing?
° How are the vats transported from area to area?
CONCLUSION
If the company submitted a form, a copy of the form will be attached to the
target sheet. Review the submission when pre paring the inspection report. If
there are any discrepancies between what was reported and What was observed during
ttie plant site review, note the discrepancy ard Include it 1r the Inspection report.
CLOSING CONFERENCE
Summarize the information discussed during the inspection with the
company's representative. Inform the representative that the Information
will be reviewed by the Environmental Protection Agency.
A»swer any quest tons and provide outreach Information, Personnel 1n
Industry Assistance are also available to answer any questions and clarify
the Rule.
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pflTT-1N SPECTIOOCTT vTHTs
Inspection Report
In order to clearly determine the types of processps employed during
manufacturing and processing, a detailed explanation of the processes should be
given in the inspection report. Because each operation in the process of the
chemical can proceed in a different manner, some closed, some open, and some with
limited release, it may be helpful to define each operation separately.
For example:
Mix Tank - open process (describe)
Batch Reactor - open process (describe)
Centrifuge - closed process (describe)
Dryer - closed process (describe)
Consider the following questions when describing the operations. All of
those questions are included in the data review questions and should be obtained
during the record and plant site review.
0 What does the particular operation do?
0 Are samples ever taken?
0 Is there any release of chemical or by-product?
° Are employees ever in direction tact with the chemical?
0 How is the chemical transported to the next stage?
Transmittal of Report
The inspection report and all accompanying data will be forwarded to the
Compliance Monitoring Branch (CMB). CMB will review the documentation and
forward the report and accompanying materials to the Case Development
Section (COS). CDS will review the report along with OTS to determine 1f there
1s a violation.
If a violation is detected, the case will be referred to the appropriate
Region for enforcement response with concurrence from the Pesticides and
Toxic Substances Enforcement Division (PTSED).
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APPENDIX I
PARENT COMPANY:
Din and Brad street No:
Address:
CONTACT PERSON:
Telephone No.:
PLANT SITE:
Dun and Brad street No:
Address:
CHEMICAL NAME:
Generic -
Specific -
CAS Number
SPECIAL CONCERNS:
§8(a) Level A
TARGET SHEET
FORM NUMBER:
PURPOSE OF INSPECTION:
[J Company Failed to Report
JJ Company Falsified Data
JJ Company Filed Incomplete Report
JJ Verification of Data Submitted by Company
JJ Other (Specify)
SUPPLEMENTAL INFORMATION:
* S'^mltter
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APPENDIX G
EPA HQ § 8(b) GUIDELINES
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DRAFT
Compliance Strategy for the TSCA Section 8(a/
Inventory Update Rule
Overview
Section 8(a) of the Toxic Substances Control Act (TSCA)
requires manufacturers and Importers to report such information
as the Administrator may reasonably require.
On June 12, 1986, EPA published regulations concerning the
Partial Updating of the TSCA Chemical Inventory Data Base in
the Federal Register (51 FR 21438). The rule requires manufactur-
ers and importers of certain chemical substances included on the
TSCA Chemical Substances Inventory to report current data on the
chemical identity, production volume, plant site, and site-lim't-
ed status of these substances.
The rule requires both initial and recurring reporting.
Substances covered by this rule include those initially reported
for the Inventory as well as those subsequently added. Certain
categories of substances are excluded from the rule and are list-
ed in the Requirements section of this strategy.
Compliance with the rule will be determined through inspec-
tions conducted by the National Enforcement Investigations Center
(NEIC) and Regions authorized to conduct section 8 inspections.
Inspections will be based on referrals by the Office of Toxic
Substances (OTS), tips and complaints, and the neutral admini-
strative inspection scheme. The Regions and Headquarters will
undertake enforcement actions arising from these inspections.
REQUIREMENTS
Manufacturers and importers of chemical substances which
are on the TSCA Chemical Inventory and are not exempt from re-
porting must report under the Inventory Update Rule.
The initial reporting period began August 25, 1986, and lasts
120 days. Subsequent reporting periods begin every four years from
the beginning of the last reporting period and last 120 days. Re-
porting is site specific, and a person must manufacture or import
10,000 pounds or more at or to a specific site in the corporate
fiscal year immediately prior to the reporting period in order
to be subject to the reporting requirements. Persons reporting
under this rule must report current data on the production volume,
plant site and site-limited status of each chemical substance.
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-2-
A manufacturer or Importer who Is not sure whether a substance he
manufactures or imports is on the Master Inventory may request
EPA to search the Master Inventory. Such requests must be made
60 days prior to the end of the reporting period to allow EPA
sufficient time to respond to the request. Persons requesting
a search will be allowed 15 business days from the date of
receipt of EPA's answer or the end of the reporting period,
whichever is later, to submit the report.
There are four broad categories of chemicals exempt from
reporting under this rule. These are polymers, Inorganic sub-
stances, microorganisms, and naturally occuring substances.
Section 710.26 of the rule and the preamble to the rule pro-
vide more precise definitions of the exempt categories. Even
if a person manufactures or imports a reportable substance,
he may still be exempt from reporting if he:
1)	produces less than 10,000 pounds of a substance at a
particular site during the corporate fiscal year pre-
ceding the reporting period;
2)	is a small manufacturer under the definition of the
rul e;
3)	produces a substance solely for research and development;
4)	imports a substance as part of an article; or
5)	manufactures a substance as an impurity, byproduct, non-
isolated intermediate, or incidental to another operation
or upon end use of another substance or mixture.
A chemical substance which falls into one of the exempt
categories must still be reported if it is the subject of a rule
proposed or promulgated under sections 4, 5(a)(2), 5(b)(4), or 6 ol
TSCA, of an order issued under sections 5(e) or 5(f) or of relief
which has been granted under a civil action under sections 5 or 7.
Persons subject to the Inventory Update Rule are required to
maintain records which document the information contained in their
submissions. These records must be maintained for four years after
the end of the applicable reporting period. If a substance 1s not
reported because its site-specific annual production or importation
for the previous fiscal year 1s less than 10,000 lbs., site-specif:
production or importation records must be kept at the plant site oi
corporate headquarters to document that fact. Persons who qualify
for a small business exemption for a particular substance must be
prepared to document their claim.
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Regulated Industry	
The regulated Industry consists of manufacturers and importers
of chemical substances listed on the Master Inventory File, who
produ-c more than 10,000 lbs. of a substance at any site provided
chey do not qualify for an exemption.
'compliance monitoring
Compliance monitoring will be accomplished through inspections
conducted by NEIC and Regions authorized to conduct section 8 in-
spections. Inspections will be based on referrals by OTS, tips
and complaints, and the neutral administrative inspection scheme.
The Regions and Headquarters will undertake enforcement actions
arising from these inspections.
The Office of Toxic Substances will analyze the ,-espouses
to the Inventory Update Rule submitted and develop a list of
potential Inspection targets. This list will be forwarded to
the Office of Compliance Monitoring (OCM) for transmittal to NEIC
and the Regions.
The Regions and NEIC will also conduct random inspections of
submitters under the neutral administrative inspection scheme for
section 8 inspections. During these inspections, the inspector
should determine whether the company reported under the rule,
whether the required records are being maintained and if the
company did not report, whether they have records documenting any
claimed exemptions from reporting.
Hps and complaints will be investigated as received, and
should have the same priority as OTS referrals when scheduling
inspections.
Administrative penalties for violations under this rule will
be assessed in accordance with the Section 8, 12 and 13 Enforce-
ment Response Policy.
Neutral Administrative Inspection Scheme	
Regions II, III and V and NEIC will conduct Inspections
according to the neutral administrative inspection scheme
outlined below. Inspections targetted In accordance with
the NAIS will be Integrated Into the existing §8 inspection
program.
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¦ 4-
Inspections under this rule will be targetted from persons
who submitted Information under the rule, persons who were
provided forms but did not submit Information under the rule.
/!pe>sons^wTTp~~rgport~e
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APPENDIX H
EPA HQ § 8(C) GUIDELINES
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INSPECTION PROCEDURES
TSCA Section 8(c)
Records and Reports of Allegations that
Chemical Substances Cause Significant
Reactions to Health or Environment
Background	
On August 2 2, 1983, the Environmental Protection Agency
(EPA) published in the Federal Register the TSCA §8(c) rule
(40 CRF 717). The rule requires all chemical manufacturers,
and certain processors including petroleum refiners to keep
records of allegations of significant adverse reactions to
human health or the environment. This information will be
used by EPA to check patterns of new or previously unrecognized
adverse effects from chemicals as an indication of a potential
prob1 em.
More recently, The Office of Compliance Monitoring and
the Office of Toxic Substances are coordinating their efforts
to increase awareness which will serve to both foster compliance
and provide potential "tips and complaints" through increased
awareness of the program. These efforts are concentrated in
developing training for the regions and brochures and videotape
on 8(c) for distribution to industry and environmental groups.
Objective of the TSCA Section 8(c) Inspection
Verification inspections will be conducted to monitor
compliance with the rule at the largest possible number
of sites. The compliance strategy indicates that inspec-
tions will be conducted to monitor compliance with the rule
by reviewing records to ensure all appropriate information
is on file.
During these inspections, it will be important to determine
the company's awareness of the 8(c) rule and if they have some
type of outreach program or procedure to inform their personnel
of the 8(c) rule. Unless some type of awareness of the rule
has been initiated, the likelihood that allegations will be
filed is reduced.
Selection of Companies
The TSCA Section 8(c) inspections will be conducted at each
Section 8(a) and/or Section 5 site as a secondary inspection
to allow the largest possible number of sites to be inspected.
"For Cause" inspections will be conducted in response to tips/
complaints from OTS, industry or the general public and will
be forwarded to the regions on a case-by-case basis.
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Recordkeepi ng Ru 1e Requirements	
Manufacturers and Processors Required to Maintain Records
Any manufacturer of a chemical substance is subject
to the rule. Also subject are chemical processors whose
TSCA covered end products are covered by Standard Industrial
Classification (SIC) codes 28 -- Chemicals and Allied Products
or 2911 -- Petroleum Refining (Copy attached). Manufacturers
or manufacturing activities not subject to the rule include
mining or other solely extrative functions.
The definition for "significant adverse reactions" are
reactions that may indicate a substantial impairment of
normal activities, or long-lasting or irreversible damage to
health or the environment.
Firms are not required to record significant adverse
reactions that are known human effects, meaning a commonly
recognized human health effect of a particular substance or
mixture, as described either in 1) scientific articles or
publications abstracted in standard references sources or
2) the firm's product labeling or Material Safety Data Sheets.
Firms are not required to record significant adverse
reactions to the environment if the alleged cause of that
significant adverse reaction can be directly attributable
to an incident of environmental contamination that has been
reported to the Federal Government under any applicable
authority such as 1) an accidental spill or other accidental
discharge, or 2) emission exceeding permitted limits.
Reporti ng
There is no automatic reporting provision. The 8(c)
rule provides that when 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.
Recordkeepi ng
All allegation records are to be maintained as referenced
in §717.15 of the rule. These requirements are outlined in
the Inspection Activities portion of this guidance document.
Allegations of adverse reactions to the health of an
employee must be maintained for 30 years. All other allegations
are maintained for five years. If a firm ceases to do business,
its succesor must receive and maintain the records. If there
is no successor, these records must be transferred to EPA.
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- 3 -
Confidentiality
Due to the nature of the type of information that should
be maintained in the records, confidential claims covering
all or part of the files may be asserted. Handling of CBI
will be governed by the procedures set forth in the TSCA
Confidential Information Security Manual (October 1984).
Potential Violations:
Falsification of records or reports
Failure to keep complete records
Failure to report completely or properly
Failure to report on time
"For cause" inspections based on tips and complaints will be
the major mechanism for identifying failure to keep records
or falsification of records. Routine verification inspections
are unlikely to uncover such violations.
Inspection Activities	
Pre-inspection
Guidelines for pre-inspections and inspection activities
(i.e. preparation of documents, entry, opening conference)
should be conducted as detailed in Chapter 3 and 6 of the
TSCA Inspection Manual, Volume One.
If the company to be inspected is a large facility,
check with OCM. OCM will coordinate with OTS to provide a
specific chemical and possibly offer some supplemental
information if available.
Data Review and Documentation
Awareness:
The firm's general awareness of the 8(c) rule plays an
important part in allegations being filed under this rule.
In some instances, company officials have indicated that
they had no knowledge of 8(c). Although this is not an
enforceable requirement, during routine compliance inspec-
tions it is important to inquire about any company internal
directives or training programs relative to 8(c). This
information should be addressed and documented in the
inspection reports:
o Methods, if any, company uses to inform company employees
of the 8(c) rule. Documentary evidence such as written
directives or record maintenance procedures should be
obtained when possible. Note also if the company has a
copy of the 8(c) rule.
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o Procedures taken if an allegation is reported (i.e.
contact person assigned, or office where allegations can
be reported directly).
o Locations where allegations for that company are to
be filed. (The rule requires records to be maintained
at the firm's headquarters office or at a location
central to their chemical operation. It should be
documented in the inspection report if the HQ office is
responsible for maintaining any reported allegations or
if that site or some other location maintains the records.
Obtain an address of the location where records are main-
tained if it is different from the site being inspected.
Also obtain the name of the person who may be contacted
at that location regarding 8(c) records).
A11egati on File Review:
No allegati ons on file: If no allegations are on file, the
inspector should inquire if any allegations have been
reported and it was determined by the company that a record
of that allegation was not subject to be recorded under the
rule. The :nspector should list in the inspection report
the allegation that was not recorded and the company's basis
for not maintaining the allegation, i.e. 717.12 (c) or (d).
A11egati ons on file: If the company has a 11egation(s) on file,
the rule requires specific information be contained in the
record. The inspector will review the files to ensure all
reportable information is on file. Each of the required
reportable items of information must be individually addressed
and clearly stated in the inspection report to indicate that
the item was reviewed and whether or not it was included in
the file. If more than one allegation is on file for
different chemicals, each file reviewed is to be addressed
seperately within the inspection report. A review format has
been attached for your use (Attachment A).
Additional Information: In addition to reviewing the
al1egation(s), record keeping procedures and file struc-
ture, the inspector should 11st in the summary the number
of allegations that are on file and the chemical involved.
Multiple Allegations: If multiple allegations have been made
for the same chemical, process, etc. the inspector should
obtain copies of these allegations for review by OTS. For
example if severe headaches and shortness of breath, have
been reported by two workers who are involved in a new
chemical process, copies of these allegations should be
collected.
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Allegations Supporting 8(e): The inspecto- should determine if
any allegations on file relate to or support reporting under
Section 8(e). Such allegations and they related 8(e) submission
should be noted in the inspection report.
Record Defi ciences: Deficiencies in the allegation files
should be documented by the inspector:
o If allegation(s) on file do not contain all required
information the inspector should obtain a copy of the
deficient al1egation(s) and include these documents
as exhibits in the inspection report.
o If records are not accessible in the manner described
in the rule for recordkeeping requirements, the filing
system and specific deficiences should be described in
detail in the inspection report and any written filing
procedures should be collected.
CIosi ng Conference	
Summarize the information discussed during the inspection
with the company's representative. Inform the representative
that the information will be reviewed by the Environmental
Protection Agency.
Answer any questions and provide outreach information.
Personnel in TSCA Assistance are also available to answer
any questions and clarify the Rule.
Post-Inspection Activities
Inspection Reports
A written narrative report should be developed to support
information provided on the checklist format. A summary portion
should also be included in the inspection report. All items of
information collected as evidence should be attached to the report.
Transmittal of Report
The inspection report and all accompanying data will be
forwarded to the Compliance Division (CD). CD will review the
documentation and forward the report and accompanying materials
to the Case Development Branch (CDB). CDB will review the
report along with OTS to determine if there is a violation.
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ATTACHMt NT A
8(c) Items of information that are to be included in the
inspection report. This can be used as a check list.
1. Internal 8(c) procedures:
	 Copy attached
	 No documented procecures available. Internal procedures,
provided verbally, are described below:
2. Person to receive 8(c) allegations (name/address/phone)
[717.15(a)]:
3. Location(s) maintaining company's 8(c) allegations
if different from site being inspected [717.15(a)]:
4. Description of any reported allegations that were
determined by the company as not being subject to
the rule, and the company's basis for not recording
the allegations [717.12 (g) and (d)]:
5. Records must be retrievable by the alleged cause of the
adverse reaction (i.e. a specific chemical identity,
a mixture, an article, a company process or operation,
a site emission, effluent or other discharge). How
were these records filed? [717.15(c)]:
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(at tachmont)
A description of the nature of the alleged environmental effect!*
identifying the affected plant and/or animal species, or contami-
nated portion of the physical environment.
yes	 no	
The results of any self-initiated investigation with respect
to an allegation.	yes	 no
(EPA does not require persons subject to this rule to investigate
allegations received, and no provision of this rule shall be
construed to imply that EPA recommends, encourages or requires
such investigation.)
Copies of any further required records or reports relating to
the allegation. For example, if an employee allegation
results in a requirement for the firm to record the case on
Occupational Safety and Health Act of 1970), a copy of that
OSHA record must be included in the allegation record.
Was copy included?	yes	 n_o	

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APPENDIX I
EPA HQ § 8(d) GUIDELINES
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INSPECTION GUIDELINES
TSCA Section 8(d)
Health and Safety Studies
Submission of Lists and Copies of
Health and Safety Studies
Background	
On September 2, 1982 the final rule was published to implement
the TSCA 8(d) requirements (40 CFR 716). The rule requires all
persons who manufacture, process and persons proposing to manufacture
or process to submit unpublished health and safety studies on all
chemical substances or mixtures selected by the Interagency Testing
Committee (ITC) as well as other chemicals seperately selected by
EPA. (The ITC, established under 4(e) of TSCA recommends chemical
substances and mixtures for priority consideration by EPA in the
issuance of testing rules under 4(a) of TSCA). A copy of the final
rule is attached.
Objective of Inspection
The enforcement of the rule will be to detect violators by
effectively using limited resources and to provide further incentive
for compliance with the rule.
Selection of Companies
The TSCA Section 8(d) inspections will be conducted at each
Section 8(a) and/or Section 5 site as a secondary inspection to
allow the largest possible number of sites to be inspected using
limited resources. "For Cause" inspections will be conducted in
response to tips/ complaints from OTS, industry or the general public
and will be forwarded to the regions on a case-by-case basis.
Reporting Rule Requirements
All persons who manufacture, process and persons proposing to
manufacture or process chemical substances or mixtures listed 1n
the rule are required to submit copies of all completed health and
safety studies within their possession, as well as a 11st describing
any ongoing studies and studies known to the respondent (§717.6 and
717.7). Persons who are not involved with a chemical when it is
listed but manufactured or processed it or proposed to do so any
time during the ten years prior to the time it 1s listed, are
required to submit copies of studies for that chemical, but are not
required to list studies.
Any person in possession of a study may be required to submit
it. The rule, however, limits the initial submission of studies to
manufacturers or processors of chemicals or those persons who pro-
pose to manucture or process- a listed chemical. The rule further
limits the file search to studies in currently active files. For
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purposes of this rule persons do not have to search files retired
prior to December 3 1 , 1 9 7 9 . Companies can limit their search for
information to files in which such information is expected to be
found in the ordinary course of business. Other persons in
possession of studies would submit them only upon request by EPA
after the studies had been listed by the initial group of submitters.
Persons whose activities are of a strictly charitable or
purely academic nature are excluded. Distributors are exempt
from the ru le.
Report! ng Peri od
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 (§716.17). For chemicals appearing in the
Federal Register Notice of September 2, 1 982 the reporting date is
December 3, 1982. The rule also contains a sunset provision which
provides that within three years after a chemical substance or mixture
is added to the list, the reporting requi rement on that substance
will terminate. However, ongoing studies must be submitted whenever
they are completed. If EPA determines that reporting on a specific
chemical should be continued, a notice to that effect will be pub-
lished for comment.
Recordkeepi nq
There are no mandatory record keeping requirements in this rule.
Confi dentia 1i ty
Due to the type of information that may be reviewed or collected,
confidential claims covering all or part of the files may be asserted.
Handling of CBI will be governed by the procedures set forth in the
TSCA Confidential Business Information Security Manual (1984).
Potenti al Violati ons:
Five potential violations of the 8(d) requirements in order
of pri ori ty are:
o Falsification of records or reports/
Failure to report or keep records;
o Incomplete reporing or recordkeeping; and
o Failure to report by the required date.
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1NSPLCTI ON ACT I V IT I ES
P re-inspectlon
Guidelines for P re-i nspect l ens and inspection activities
(i.e. preparation of documents, entry, opening conference)
should be conducted as detailed in Chapter 3 and 6 of the
TSCft Inspection Manual, Volume One.
Oata Review/Documentation
Awareness:
It is essential for effective enforcement of this rule that
industry is well informed of 8(d) requirements. An OTS outreach
program was developed to notify industry that tne rule had
been promulgated and of its obligation under 8(d). Therefore,
during the routine secondary 8(d) inspectiors inquiries should
be made regarding the company's awareness of 8(d) requirements.
Document ation:
Documentation in the inspection report should reference each
point covered in the inspection relative to awareness of 8(d)
and specific B(d) procedures. This information will be useful
to OTS informing companies in geographic areas where it was noted
that there was no knowlecye of ttie 8(d) rule. Specifically, trie
inspector should include in detail in the inspection report:
o Whether the company has a contact person responsible for
1) keeping track of the 8(d) rule; 2) being aware of the
chemicals that are amended to the existing list §716.17;
and 3) knowing which of their chemicals are subject to be
reported. Is that person responsible for submitting reports
under this rule? A name and phone number should be provided.
o Is there a central file or office where a copy of the 8(d) rule
and amendments are maintained? A review of this file should be
conducted and the dates of Federal Register notices or other
directives, notices, or directives relative to 8(d) should be
noted.
o Are there internal procedures for monitoring/ tracking any
studies to determine when the company is subject to report
under 8(d)? Obtain a copy if available. If no copy is
available, describe in the inspection report any procedures
that are provided verbally.
o Is there a testing facility on-site, at the headquarters
site, or are contractors used? Provide the names and
addresses if other than the site being inspected.
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o Are there any studies that have been submitted to EPA under
the 8(
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APPENDIX J
EPA HQ § 8(e) GUIDELINES
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INSPECTION GUIDELINES
TSCA Secti on 8(e)
Notification of Substantial Risk
Background	
The self-implementing provisions of Section 8(e) of TSCA went
into effect on January 1 , 1 97 7 . Section 8(e) requi res any person
who manufactures, processes, or distributes in commerce a chemical
substance or mixture and wno obtains information which reasonably
supports the conclusion that such substance or mixture presents
a substantial risk of injury to health or environment shall
immediately report that information to EPA unless such person has
actual knowledge that the EPA has been adequately informed of
such information. (A copy of the Policy Statement is attached.)
Objective Of Inspection
The objective of these 8(e) inspections will be to ensure
compliance with Section 8(e) and to inquire about the company's
internal procedures for handling and reporting "substantial risk".
Selection of Companies	
Routine 8(e) secondary inspections will be performed with each
orimary 8(a) or Section 5 inspection. Information submitted
jnder 8(a), 8(c), 8(d) and Section 5 can be an effective monitoring
tool because these studies may contain 8(e) information.
Most of the activities undertaken to investigate a violation
under 8(e) will be in response to tips/comp1aints and will
be forwarded to the regions on a case-by-case basis.
Reporting Requirements
Persons subject to Section 8(e) substantial risk reporting
requirements include both natural persons and business entities
engaged in manufacturing, processing or distributing in commerce a
chemical substance or mixture. A person obtains substantial-risk
information at the time he first comes into possession of or knows
of such i nformation.
The term substantial-risk information means information
which 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 the
seriousness of the effect and the fact of 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.)
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A copy of these reportable effects are listed in Attachment C
of this portion of the guidelines.
Reporti nq Peri od
Section 8(e) requires "substantial risk" information to be
reported immediately. A person has immediately informed the EPA
if information is received by EPA not later than the 15th working
day after the date the person obtained such information. Supple-
mental information received after submission of an 8{e) notification
should, if appropriate, be immediately reported.
Recordkeepi ng
There are no mandatory recordkeeping requirements under
Secti on 8(e).
Confi denti ali ty
Due to the type of information that may be reviewed or collected,
confidential claims covering all or part of the files may be asserted.
Handling of CBI will be governed by the procedures set forth in the
TSCA Confidential Business Information Security Manual (October 1984).
Potenti al Vi olatiors:
o Falsification of records or reports/
^Failure to report or keep records;
o Incomplete reporting or recordkeeping; and
o	*"	red date.
Guidelines for ?re-i nspect i ons and inspection activities (i.e.
preparation of documents, entry, opening conference) should be
conducted as detailed in Chapter 3 and 6 of the TSCA Inspection
Manual, Volume One.
Awareness:
OTS has over the years been informing the affected industry and
the general public about 8(e) through printed information and
public meetings. EPA published a statement of interpretation
and enforcement policy which explains the Agency's position
regarding the requirements for compliance with 8(e) [43 FR11 110;
March 16, 1978].
INSPECTION ACTIVITIES
Pre-i nspecti on
/
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In order for a company to report 8(e) information, it is
essential that the person who has the information is aware of
3(e) in order to recognize it as evidence of substantial risk
and therefore is reportable. Therefore, it is important to
continue to inquire about the company's system for handling and
reporting 8(e) information.
It is equally important if files are being reviewed during
inspection under Sections 8(a), (c), (d) and 5 of TSCA, that
the inspector is able to recognize 8(e) information. There may
be instances where the data may reference other data or studies
which should be submitted under 8(e).
Documentati on:
Statements in the inspection report should discuss each
point covered during the inspection relative to awareness of
8(e) and specific internal tracking procedures. Included in
the inspection report should be documentation:
o Does company maintain copy of the Section 8(e) and state-
ment of interpretation in their files in order to effectively
report under these provisions?
o Is there a contact person at the site responsible for
tracki ng/moni tori ng studies to determine when the information
is reportable under 8(e)? Obtain the name, phone number of
that person.
o Are there internal procedures on file outlining their policy
for recognizing and reporting under 8(e)? A copy of that
procedure should be an attachment to the inspection report.
o Has the company reported any information to EPA under
8(e)? List their submissions in the inspection report.
o Is there a testing facility on-site or at the headquarters or
are contractors used? That should be noted in the inspection
repo rt.
When a company is an 8(e) referral due to tip/complaint, the
specific type of information that should be collected and
documented in the inspection report will be outlined in the
referral.
CIosi ng Conference
Summarize the information discussed during the inspection with
the company's representative. Inform the representative that the
information will be reviewed by the Environmental Proection Agency.
(Guidelines for closing conference activities should be conducted
as detailed in Chapter 3 of the TSCA inspection Manual Volume One.
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^ost -1 ns pect i on Activities	
Inspection Reports
A written narrative report should be developed to support
information provided on the review format. A summary portion
should also be included in the inspectin report. All items of
information collected as evidence shoufd be attached to the
report. Procedures for preparing inspection reports are outlined
in Chapter 4-1 of the TSCA Inspection Manual Volume One.
Transmittal of Reports
Initial case review and determination of possible violation
should be performed by the regions prior to forwarding the
reports. To expedite review of the reports of those companies
that the regions determine to be in violation, indicate in the
transmittal memorandum the names of the companies. Priority
review will be given to those reports. The inspection report
and all accompanying data will be forwarded to the Compliance
Branch (CB). CB will review the documentation and forward
the report and accompanying materials to the Case Support
Branch (CSB). CSB will review the report a-Lo«*}. w-i-th coordi-
n-a-t-4-ofl with OTS to determine if there is a violation.
If a violation is detected, the case will be referred
back to the appropriate region for enforcement response with
concurrence by the appropriate HQ compliance offices.
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APPENDIX K
§ 8(e) INTERPRETIVE STATEMENT
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TH jOAY, MARCH 16, 1978
PART V
ENVIRONMENTAL
PROTECTION
AGENCY
TOXIC SUBSTANCES
CONTROL ACT
Statement of Interpretation and
Enforcement Policy; Notification
of Substantial Risk
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Hill
[43*0-01]
IMVtRONMlMTAl PtOTICTlOM
AOIMCY
C7!U.M»-&
TQ9C MtCTAMCM OONTKM ACT
HeMMwfre t» Utilii Hil ttak IMw
U+m*»)
AOENCT Environmental Protection
Agency.
ACTION: Staturnsnt of interpretation
and enforcement policy.
SUMMARY: This action itiln CPA'*
Interpretation of. tod enforcement
policy oonceminc* section 8(e) of the
Toxic Substances Control Act CTSCA)
(80 SUt. 3039, 18 UAC. 3607). The
provisions of that section vent Into
effect on January 1.1977.
Section 8
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ban uin sinoe January U MTT. Id
respaiuo to requests far rlariflntlon,
the —>*T—1*	What Constitutes
such mnm Id (his manner, CPA
intends to Unit the need for searches
of historical records and fUsa,
(6)	This pallor statement now pro-
vides that any Information published
to literature, Id ioj lan-
guage. la axampt 12 It la referred to in
abstracts published by specified ab-
itnettBi services.
(7)	This poller statement daaoibaa
tn a new Part X how to submit claims
of confidentiality.
Aooordlngly, Admlslitntor'i In-
terpretation of and poller towards soo>
Uon Ma) la set forth below.
Dated: February M, 1*TI»
Doxraus Cosn*
Adminiitrator.
L Dsrnrmon
The definitions set forth to TSCA
¦action 3 apply to these requirements.
In addition, the following definitions
are provided for purposes of thla
poller 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, (3) for us* aa a
catalyst or an Intermediate, 0) for the
exclusive, use by the manufacturer or
wwjcaaw. or (4) for product research
and development.
The term "person" Includes any nat-
ural person, corporation. Ann. 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 Una "substantial-risk tnforma.
Man" means Information which re^
"¦"fciT supports the conclusion that a
chemical substance or mixture pre-
sents a lubatanrlal dak of Injury to
>1 —Ittl Qf th« WHtHUMli
H. Puiun Suawi to TO
RwmaoR
Persons subject to section We) p»>
qulresnents Include both-oatuni per-
sons bustneas entitles engaged In
manufacturing, piwrulng. or distrib-
uting In commerce a	' sub-
stance or mixture. In the ease of busi-
ness entitles, tha president, chief ex-
ecutive officer, aod any other officers
responsible and bavtng authority for
the organisation's execution of Its sec-
tion Me) obligations must ensure that
the organisation reports substantial-
riak Information to EPA. ine business
organization Is considered to have ot>
I iId^I any tnfonnatlon which uy of-
ficer or employee caps Me of appreciat-
ing the significance of that Informa-
tion has obtained It is therefore u>
HOTli
eumbeat "t**1** busi> • organisations
to estshltsh proct .i for eiporti-
tlously processtoiB =nsnt Informs*
tlon in order u. ply with the
schedule aet fort; .rtlY.
Those officers 4 employees of
business organizations who are capa-
ble of appreciating the significance of
pertinent information an also subject
to thase reporting reoulremanta. An
employing organisation may relieve its
Individual officers and employees of
any responsibility for reporting sul>
stantial-risk Information directly to
EPA by establishing, internally publl-
tnH affirmatively
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; (3) indicate how such
submissions are to be prepared and
the company official to whom they are
to be submitted; (3) note the Federal
penalties for failing 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. as protected by
TSCA section 23). An employee of any
company that has established and
publicised 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, ill off]dais 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-
ed to EPA.
Business organisations that do not
nstshllsh such procedures cannot re-
lieve their Individual officers and em-
ployees of the responslbllty for ensur-
ing that	lnhiim«Hiw
they obtain is reported to EPA. While
officers and employees of such organi-
sations may also elect to submit sub-
stantlal-rUk Information to their supe-
riors for corporals 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 a Mistnm organte-
Bob's doditoo to Mlih >Ad	Um
procedure* described above. It Is responsible
for hemmlnt cognisant of any fubtfantlal-
rlsfc InferntaUoa	by Its ofOoan and
emoioyees. and lor ensuring that sucb toior-
mattrw Is reported to XPA wubla IB vacfc-
ins dan.
m. Wbsr k Pessob Wax Bi Rnusa
as Hansa Oizmns lawismow
A person obtains substantial-risk In-
formation at the time he first comes
11111
Into possession of or knows of such l»
formation.
Hon—This Includes tnforaaUaa of
vUeii a prudsat para timiiarly minted
eeuid reasonably be aspeeud to rnw or
bava knovtadga.
An establishment obtains Informa-
tion at the time any officer or
ployee capable of appreciating the sig-
nificance of such Information obtains
it.
IV. Xnmnan Thit a Pnsow "Im.
MBiamr Ixvqik" tas Aawronu-
toa
With the exception of Information
ob emergency incidents of environ-
mental contamination [see Part V(c)l
a person 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.
Far emergency Incidents of environ-
mental contamination, a person
report the Incident to the Administra-
tor by telephone aa soon as be has
knowledge of the Incident (see Part IX
for appropriate telephone contacts).
The report should contain aa much of
tha Information required by Part IX
u possible. A written report In accor-
dance with Part IX (a) through (f) la
to be submitted within 15 days.
Information currently In the posses-
sion of a person who is subject to re-
porting must be reported within SO
days of publication of this policy state-
ment.
V. Waa CossiJiuisa Suasumu.
A "substantial riak of Injury to
health or the environment" la a risk of
considerable concern because of (a)
the seriousness of the effeet Csee Sub-
parts (a), (b). and (c) below for an il-
lustrative list of effects of concern),
and (b) tha fact a probability of lu
ucoinema. (Economic or nodal bene-
fits of use, or costs of restricting use,
are not to bo considered in determin-
ing whether a risk Is "substantial".)
These two criteria are differentially
weighted for different types of effects.
The human health effects listed In
Subpart (a) below, for example, are so
serious that relatively little weight la
given to exposure; the mere fact the
ebwnlral Is in commerce
constitutes sufficient evidence of expo-
sure. In contrast, the remaining ef-
fects Usted tn Subparts 
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11111
poodsat has actual knowledge that
the Administrator ta slrvady bfomed
of them.
(II) Information respecting thaaa ef-
facts cu be obtained either directly,
by obeervation of their occurrence. or
Inferred from	startles u dis-
cussed In Put 7L
Ths Agency oansldan effects for
which substantial-risk information
must ba reported to laotude the fol-
lowing:
(a)	ffmoi' heaWi «0tet»—(1) Any
of cancer, Mrth defects. mu-
tagenicity. daub, or serious or pro-
longed	» Including the
loaa of or Inability to aaa a normal
bodily function with a ooraequent rel-
atively serious Impairment of normal
activities. If one (or a raw) chemloaKs)
Is strongly implicated.
(3) Any pattern of effeeta or evt-
dance which reasonably supports the
conclusion that the ffhftnlrel sub-
stance or mixture can produce cancer,
mutation, birth defects or toxic effects
resulting In death, or serious or pro-
longed Incapacitation.
(b)	Environmental effect*—(15 Wide-
iprud and previously unsuspected dis-
tribution in environmental media. as
tn studies (excluding materi-
als contained within appropriate dis-
posal facilities).
(3) Pronounced Moaeeumulation.
Measurements -*nd Indicators of pro-
nounced Moaeeumulation heretofore
unknown to the Administrator (Includ-
ing	in Bah beyond
5,000 times water concentration In a
30-day exposure or having an n-oe-
tanol/water partition coefficient
greater than 39,000) should be report-
ed when coupled with potential far
widespread exposure and any non-triv-
ial advene effect.
(3)	Any ran-trivial advene eft set,
haretofore "¦> m«n to tha Adminis-
trator. associated with a cfirrnfral
known to have btoaocumuUted to a
pronounced degree or ta ba wide-
spread in environmental
(4)	Boolodcally	ehangea
In ipylw' interrelationships; that la,
ehangea tn population behavior,
growth, survtval. eta that In turn
affect other species' behavior, growth,
or survival.
Examples Include: (D Kfcteaslra sttm-
ulation of primary producers (algae,
microphytes) In aauatie ecosystems,
e.g* resulting In-nutrient enrichment,
or eutrophlcatlon. of aquatic eooaya-
(U) Interference with crtUcal blogeo-
oh—iioai cycles, ruch as tha nitrogen
cycle.
(9) Facile transformation or degra-
dation to a chemical having an unac-
ceptable risk is defined above.
(e) Emergency Incident* of environ-
mental contamination—Any envtron-
wiijt.wiiw.Hwi \)j | chemical
substance or mixture to which any of
noikb
the above adverse effects has been s»
crlbed and which because of the pat-
tarn. extent, and amount of contami-
nation (1) aerloualy threatens humans
with cancer, birth defects, mutation,
death, or serious or prolonged inca-
pacitation. or (3) seriously threatens
non-human organisms with large-scale
or ecologically significant population
destruction.
VL Nuni um Soutcxs or Ibvorma-
tiow Waxes "Riasobaslt Surmais
to CojKLoaxo*" or SnsxAimu.
Rib
Information attributing any of the
effects described In Part 7 shove to a
fiti em teal substance or mixture ta to be
reported UT it la one of the types listed
below and U It ta not exempt from the
reporting requirement by reason of
Part VH of this policy statement A
person Is not to delay reporting until
be obtains conclusive Information that
a substantial risk exists, but la to Im-
mediately report any evidence which
"reasonably supports" that conclusion.
Such evidence will generally not be
conclusive a* to the substantiality of
the risk: It should, however, reliably
ascribe the effect to the chemical.
Information from the following
sources concerning the effects do-
scribed In Part V win often Tetsoiw.
ably support" a conclusion of substan-
tial risk. Consideration of corrobora-
tive Information before reporting can
only occur where it Is Indicated below.
(1) Designed, controlled ttudie*. In
assessing the quality of Information,
the respondent Is to consider whether
it	reliable evidence ascribing
the effect to the chemical. Not only
'inmiit final results from such studies
be reported, but also preliminary re-
sults from incomplete studies when
appropriate. Designed, controlled stud-
lea Inetudec
(1) In vtvo experiments and tests.
(ID in vitro experiments and testa.
Consideration may be given to the ex-
istence of corroborative Information. If
neoeassry to reasonably support the
Tyjir4"" that a chemical presents a
substantial risk.
(Ill) Epidemiological studies.
(Iv) ttivtronmental monitoring stud-
ies.
(3) Reports concerning and itudies
0f undesigned, mncontmOed rtrrum-
itancex. It Is anticipated here that re-
portable effects will generally occur In
a pattern, where a significant common
feature Is exposure to the chemical.
However, a single Instance of cancer,
birth defecta, mutation, death, or sort-
oue incapacitation tn a human would
be reportable if one (or a few)
chemlc&Ks) was strongly Implicated,
in addition, it Is possible that effects
leas serious than those described In
Part 7(a) may be preliminary manifest
tattoos of the more serious effects
and. together with another triggering
pieoe of Information, constitute repor-
table Information: an example would
be a group of exposed workers experi-
encing rttmlneas together with prelimi-
nary experimental results demonstrat-
ing neurological dysfunctions.
Reports and studies of undesigned
circumstances include;
(i) Medical and health surveys.
(II)	Clinical studies.
(III)	Reports concerning and evi-
dence of effects In consumers, workers,
or the environment.
TIL Iifonuxxoa Waxes Nob Not Bi
Rooms
Information need not be reported If
it:
(a)	Has been published by EPA In re-
Ports>
(b)	Has been submitted In writing to
EPA pursuant to mandatory reporting
requirements undet. TSCA or any
other authority administered by EPA
(Including the Federal Insecticide.
Pungldde and Rodentlcide Act, the
Clean Air Act, the Federal Water Pol-
lution Control Act. the Marine Protec-
tion. Research, and Sanctuaries Act,
the Safe Drinking Water Act. and the
Resource Conservation and Recovery
Act), provided that the Information:
(1) tacnraptssm that required by Part
IX (c) through  Part
V(c). or
(e> Is contained In notification of
spills under section 311(bM9) of the
Federal Water Pollution Control Act.
Tin. iHVOBManoH Pnsr Rscsxvxd by
a Pnsoii Paioa to tax Eswnvs
Diss or TSCA
Any substantial risk Information
possessed by a person prior to Janv ,
L. 19TI. of which he Is aware after :ai
date shall be reported within CO :ays
of publication of this policy statement.
The Agency considers that a person is
"aware" of:
(a) Any Information reviewed after
January 1, 1977.	not only
written reports, memoranda and other
documents examined after January 1.
19TT. but also infonnatton referred to
In discussions and conferences In
which the penon participated after
January L49TT;
NMLU UOBIM. VOL O, NO. 33—THUSSDAT, MAXCMIt, 1VTI
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1111}
 Summarise the advene effect*
Ming reported, describing the nature
sad the extent of the risk Involved,
sad
(f) Cmilain the specific source of the
Information together with a summary
aad the source of aay available sup-
porting technical data.
Pot emergency Incidents of environ-
mental contamination (see Part 7(c)),
a penoa shall report the Incident to
the Administrator by telephone as
¦oao as he has knowledge of the Inci-
dent ceee below for appropriate tele-
phone contacts). Tie report should
sa much of the information re-
quired by Instructions  through (f)
above as possible. A written report, la
accordance with Instruction*, (a)
through  above, la to be submitted
within U day* Twenty-four hour
¦ taljyhm* wmwh—¦ u»
I (Mama. Rhode bland,
cut. Varment.	Hew Hamp-
shire), 117-333-mt.
Rattan n OMw Tat. Hew Jener. Puerto
Hlco. Tirana Islands), M1-MWTM.
Beglon ni (PemuylTula, W«at Vlrtinia,
Virginia, Maryland. Delaware. OWtet of
Columbia). 2U-44T-S68&.
Region IV (Santteky, Tmwswi Horth
Carolina. Seutn CanUm. Oeorsla. Ala-
bama. Mississippi Rartdai, (04-Wl-Wtt
lUglen 7 4M
VII (lMsuki, Iowa, msaeuit
i>. ne-Jii-rrx
Saatoa vm (Colorado. Utah. Wrmlng,
(forth Dakota. South OaSotaJ,
jevsji-ssac.
Rasksi CX (California. Nevada. Artaona,
Hawaii, Ouami, il8 Ml WK
X rwaahingtoa,
aiattai. aes-tO-uodL
X. CowmnrmuTT Cuno
(a) Any penon submitting a notice
to EPA under section 8(e) of TBCA
may assert a business confidentiality
claim covering all or part of the Infor-
mation contained In the notice. Aay
information covered by a claim will be
disclosed by CPA only to the extent,
and by means of the procedures, set
forth la 40 CFR Part 2 «i PR 36901
September 1,1976).
(b» if no otalm aooompaales the
nodes at the time it is submitted to
EPA, the nodee will be placed la aa
open me to be available to the public
without further notice to the submit-
ter.
(e) To assert a claim of confidential-
ity for Information contained la a
notice, the submitter must submit two
copies of the notice.
(1) One copy must be complete. In
that copr the submitter must indicate
what Information. If any. Is claimed as
confidential by marking the specified
Information on each page with a label
such as "confidential.'" "proprietary,"
or "trade secret."
(9) If some information In the notice
Is claimed u confidential, the submit-
ter must submit a second copy. The
second copy must be complete except
that all Information claimed u confl-
dentlal In the Grat copy Inust be de-
leted.
(J) The first copy of the notice wfl]
be disclosed by EPA only to the
extent, and by means of the proce-
dures. set forth tn 40 CFR Part X The
second copy will be placed In aa open
file to be available to the public.
(d) Aay person submitting a notice
information for which they
an uaertbif a confidentiality claim
should send the notice la a double
envelope.
(1) The outside envelope should bear
the same addreaa outlined la section
EE of this policy statement.
(3) The (aside envelope should be
dearly marked "To be opened only by
the OTS Document Control Officer."
XL Pawns To Rimkt Ibpouutioh
Section ISO) of T3CA makes it un-
lawful lor aay penon to fad or refuse
to submit Information required under
section Me). Section 10 provides that a
violation of section IS renders a
pawn liable to the United States for
a dvfl penalty aad possible criminal
prosecution. Pursuant to section IT.
the Government may seok judicial
relief to compel submittal of section
We) Information and to otherwise re-
strain aay violation of section KeL
Svmaurr
Iwmiis or fimaomis*-
iit Coetuoemoe
Incident of envtronmanul
wwiaminsihm ts "any savtraaental ooo-
tamlnaiinn by a chemical substance or mix*
tare ... ehfeb, because of the pattern,
aunt and amount at nontamlnsHon.  for complete
daaeripdooJ
a wwi
IntormeUen eooUlned Is notlfleatioa at
«UU under leczloa lllcSHSl of the Federal
Water Pollution Control Act ¦ (PWPGA).
CPor a complete list of exemptions to report-
Ina. see Pan VU.}
a wnu un wsbbs m ssroar aaaaoicr
Btwrrencr Incldeata of envtroomental
contamination are to bo reported Immedi-
ately by talepbono to the appropriate CPA
Bagloaal 14-bour telepbooe emeriency line
listed below.
Beslon I fWalne. Rhode Island. Connecti-
«8t. Vermont. Uasnchowrtts. New Haap-
sbmk m-m-nsA.
Sagian a (Ifcw Tort Mew Jemr. Puerto
Sleo, Virgin Islands),
BagHn III (mnsylvanla. West Virginia,
Virginia. Maryland. Delaware. District of
Columbia], US-MT-MM.
Beglcn IV (Xantuefcy, Tsnnessee. Kortb
Carolina, Sou lb Carallna, Oeorsla. Ala-
ham a, Ifisslsippi PlarldaJ. i4HrS8I-404Z.
Beglon V (Wisconsin, HUnoia, Indiana,
""¦I" Ohio.	ai3-0Ji-
sia.
Baglsn V^OTew ¥rttti, Teaaa. Oklabema,
Artiiwaa Tmntslanai. 114-TtS-Uta.
Haelow VII UWwiti, Iowa, Maaourl.
Kansaax sia-na-ma.
Beeton VHI (Colorado, Otab, Wrominc,
Igentane. Ifettb Dasnfa. South Pasms>„
Bsglnn DC 1 California, Nevada, Artaoaa,
Hawatt, Ouaai. 41B-U0-43M.
ftsgwm X (Wasblnston,
In artiHtinsi. a written report. In
am rttn tnatmrrioia  tba sopUeation ot
otmlnaj penaJMea mandates a strict inter-
i of this worL
IMUl StOOTB. VOL 43) NOl A-THWUSAT, MAtOI I*. 1«Tt-
-------
11124
Nonas
			t ttwt dtt-
	~«t TSCA. havtag mmt
purpoaaa, w« wwpiunlj directed to dtf-
(Hat iMweitm IB tbe cm* of sertloc
•tel. sfflem sad apioreas who ait capable
at iwwIMtnr the ¦T"|MM* of Informa-
tion have a legfttmeu responsibility to bo
alert to uH report ¦mstintisl-mh informa-
tion. Tbe gatdaaee h» baa mortified so
that natural EMnooi aad batiaaes entitles
fnlflO their wrtwi ate) dWinrtw la
dUhrat wan- Meet offlcen tad niplnyeee
oa mniine their tecrVwi Me)
by -»¦—«*— pertlaeat taformattoo to cor-
porate supertora. provided that the on-
paay baa -^*KM*l,*,t tbe rtsk-evatuatlaa
utuuwhuea eharacterlMd ta Put 3. latbe
dsnt, chief executive ofOear. lad other otO-
stale issnnrelWe aad bavtng authority tar
tbe buataees isimlisilisri execoUoa of lta
section Ma) otUlgsriflns mot cnsnre that
Um nusnlisHmi reports substantial-risk In-
formation to EPA.
Ceetsieni £ Even If employees can ba bald
subject to thcM requirement*, they thould
aot be. Ta do so would force employees tad
employers Into.conflletlng positions. Inviting
Internal corporate dissension and over- rw>
portlnf. Further, individuals often do not
bate the overview neceesary to reach aoo-
Odered. well-supported decisions. Corporate
reporting by designated officials win pro-
vide SPA with more reliable <1»t»
Smonte: The Agency consider* that em-
ployms bafa a legitimate role ta rtxk repot v-
tnc It la Imperative that risk Information
by employees be appropriately
usiiHUiieri OfOcen and employeee eaa fal-
si] tbair role la the reporting of luhstsnfltl-
risk laformatioo. without the disadvantages
J Merit ml above, by nporttac Information -
to (upartan for corporate copsMertaon.
•ad. baring deaa to, win have dlaeharved
their obligation to BPA. This Is contingent
npoa the establishment by the business or-
cantation of eeitala procedures for risk-
evaluation. thereby assuring the appropj-t-
ate mnsj/ViraOon of web report*. Hioee of •
fleer* respcrwltite aad having authority for
tbe leiaiiliailm s erernttfln of. tta section
•(e) oWtf flona must insure that tha orga-
BtBttQD raporta ntattntlAtaJA loiflnu^
tton isDA
1 JT Clarify which
aad the extent of tbatr <
Are aapleyeaa "rapahla of tppredaOs* per-
it—it jaforaattoa" by ibtiia of raak. ar
kaowtadie? Arc raak tad Qo
sablaet to tbaaa raqatmaatti or Jnat i
Ttaorr aad mananrtal pec
mwiUflm «t&J la aa a
of ftmher iwpeeslbUtty if bs reports to bit
' Tba Acsney eonskhn that tbo
phnse "capable of ippietlaflm tba
eaaea of paiUueut tafomattoa" tppnjprV
amy daacrtbw thooa affleew aad tmployaaa
wbo have a nwponslWHty to be alert ta aad
report sobstaadAMak tnforaaUoa. tadud-
lac do* oolr relatively senior corporate af&-
can but alao aaay oorponta cmployeea.
Tha pelley itatement nodlflat tba i
bar 9 BroooaaL la rwaeaae to tbe <
expreasad la Onuiiiwniis 1 aad 3, to permit
meat officer* aad emplnyeea to dlachatfe
tlMtr ohUiitiOQ by lubnittlBf lpfumufloo
to eanonte mperluta. subject to tba ooadl-
tkea deootbed la Part U.
CowumnU i	utd tnteprntatt
laba should not bo subject to tbeee requlr*-
they bare abtalnad dbwtly to VA;
rather, tbatr euaat maaofaenren. proeea-
son aad dtstnbuiora are responsible fev
4"/i"- "lr"
& sb "oBuns" or araumi
Cbataiemf S: The "may suaasf ortterloa
ta Part m of the propoeai aerrea toeoooel
Author it'""" of laformatloa that by
ItaaU la not lubleet to tectloa S(e) rtqulr*-
The statutory lanruac* ealttac (or
ipoorv" doaa oot support thla.
Purther, rtak assessment oftea requtna aay-
where from months to totem yaan of
study after preliminary results luaaat"
risk, far iinsirtlnt the lft-day t"*~-
Tbe A«waay doea oot Intend to
setioa Ke>	of
tafonaauoa that by Itaalf la no*	to
sartton Kel rsqulnmeaa and has deleted
tbe "may sunset" prorukm. provtdlax its
tatorpntatlOB of what eonatltutet rrklence
that "reaaooably tupporta the eottdualoa'*
of substantial rtak la a new Part VL
Cbaunenf 1' Section tte) obligations are
Incurred upon obtaining eoneluaory substaa-
ttal-rlik lafonaaUon.
Aespontc.* The Agency disagrees, aad eoo-
stdera that "reasonable support" of a con-
clusion of substantial risk Is not Identical to
tbe conclusion Itself. The foraer typically
oocurs, aad must be reported, at aa earlier
stage.
Comment t The ttateaent la Part HI of
tbe propoeal that a penoa has obuiaed ta-
fonaatloa If he .. thould know of the ex-
istence of such laf armed on not la his poe-
seeskm but which would be-dellvered to hla
on request," leads to compel aa active
eeexch for substantial-risk information
rather thaa the reporting of substantial-risk
laformatloa a penoa "obtalaa.* This la of
particular concern to importer* with limited
access to laformatloa possessed by their
suppliers.
Response.' The Agency eooslden that se»
Uoa Ke> applies to Information wbich a
pel eon goawia or of which he kauea. It It
not ha tended to compel searehea for tnf or-
matlnn or extraosdtaary efforts to acquire
information The Agsacy rurthar casaldaak
however, that "kaowa" lafonidaa -Id-
ctudee taformatVio which a pradsat penon
MBllarly Otoated oould laatniitlip be ex-
ta kaow. Wigilisnrt or mtentmnel
of lafonaatloa does not abaotvw a
of his ssctloa Me) nhllgetloB. Put
m baa been modified to uipiass tbaaa la-
t
"tato paaaaeston" ai risk
to aa i
(¦f Of thl tBDlkltiOOl Oi hlffWeiiatUw
"nWalnsr thould ha defined ta taraa of m»
ssMloa of lafomatlon aad awareness of Its
jg^ort
fUrponsr Tba "obtafalac" of tafonnadoa
oocur* na penoas who ire "capable of ap-
predaOac the tlgnlfVinre of pertinent ta-
fomadoa." There will likely bo dreum-
stanrea ta which tha eratuadon of tnferma-
oob dan He* Its fun import: tba establish*
moat of corporate procedures for proceestng
risk-Information prescribed la Part ~ will
expedite thla.
(o
at&l
Atopease "Oie Acncy boa ebaacad tbe
nwnnllanrw period to 15 Tnmnms daya. It is
tmpantivo that pracedurea be eeuhUshed to
eipedlto the reporting of tubstaatiai-nsk la-
fomatiaa. not that nportlac confora to
ow- '¦
tioa 
formatlOD Is not wamated.
& Hiaui un amtussTioe thai most ts
Contracton sad independent
lahe are aot responsible Jot reporting lafor-
i Auawn ram oomvuuki
Oawunenf»: Ptfteea calendar days Is tasuf-
to determine whether Information
wblcb "may suggest" substantial rlak should
he reported: it Is even Insufflrwim to scoom-
mortaie normal procedural time eonstraiata
fir Hie reporting of "any tn-
of caacer. birth defecta. etc. la
hiimsni la too broad sad neb lafannac
will ba of little use; chemical worken. -
tbe caneral populating develop caaoers an-
other	of uaoenaia ettoloqy.
JUtponec: This policy statement darlflee
that tbe reporting of tingle oecurrences of
human euwer or other serious effects will-
depend upon evidence ttrocgly ixnpllratlng
one (or a few) chemical(eX
CbatsieiU tX Dermal	aad nausea
are poorly cboaea erample* of precursor
symptoms Detetla* tbeee esamplea win
ifotd	Tmphfititrtf Una vhes ottier
symptoms may be more tmportant, yet will
not eilmlnsfe tbe nhllcattan to report thest
If tbsy are suspec
ffsspneis-The.
CUsietsaf :c Bow are reportable data dt»-
trees routtw tests tocludlng
nape tests such aa IA>'st
Aespoasr Tbia policy stafrmfat dbects
tbe miUM of gpocUad effects when ua-
to Um itrtmfntstratar. Many wodne
Meed on a knowledge of toxicity
with afftsmlfal; unknown effoctt
duriac neb a range taet may have
to ba reported If they an tboaa of concern
to tbe Agency tad tf tbe tafonnattoa meets
tbe alterla set forth ta Parts V aad 7L
Oommnt IS: Tba moat widespread "la
vitro" taet la tbe Ames test, which Is subjec*
to eonskterahle debate. Clarify tbe drcua-
staares uader which positive results of L.
rttro teats must be reported.
Ranontm Put VI danOee that the re-
porUag of la vttro tests vtll depead apon
the eilitwire of corrsbomive Infonnatiaa
If aeeeatary ta reasonably support the con*
dualon of substantial rtak.
Cbameiu It Tbe dsacrlptlon of "extreme
peislitencw" as a subetantlal rlak la aa exam-
ple of tbe need to redefine part V(o) ("Xavl-
ital Effects^. Penistenee sad bio-
should be coaeidered risks
only wbea ooupled with tozldty aad signifi-
cant expoeuiv.
MM BtOTO, VOL a MX O—TMUKSOAT, HAKM It, l«r>
-------
NOTKSJ
11115
Part 7
for wbtab reporting
af-
by KmII H no Iwf llssnlasrt as a report-
able afreet but ruber to ismaliteiad to be a
of sxpaam poteaaai: it aw
•tto underlie the aeaasnsnanta deacrlbed la
Part TOiXlX Laboratory tnrttwiton of pry
nouaced htnamimnlstlon an to be reported
vtuo oouplert with possnrtsl for wtdeeprsad
awun tod say noo-crtvlal «jw til ml
OowumnU IT. The a-oetanol/w*tar partt-
ttoa ooefflrlent sililisma a p Untax fteml-
eal property. not Mnkigtrl effects. tad la
ooc aim aa T*"—of subetsnrisl risk:
further. Um valna naMd tar tba noafflrlent
lit um rxoainmiiilirtnri factor la flit da
Tba
km aadhaai
Thli potto
the reportlag of aa axpartateatal
		 at of Moaocuaulatloa when
coupled with aa advene effect aad potential
Or widespread exposuro.
CommrrU IV Tba requirement that to/or-
nation which "links" aa effect to a chemi-
eat ba reported Li coo broad tad contradict*
tba statutory language of "raasiinshly
supports".
ilasponsar Tba Agency baa provided la-a
aa* Part VI ita Interpretation of "reeaoo-
ably supporta".
CdmimI II: A determination thai Inlor-
"reasonably supports the oondu-
of aubataaUal rlak «•«««* be made la-
depeodently «f eonalder&tloaa of tiaa since
tha method aod maaner of using a chemical
Bay	tba jecurrenua of ta effect;
m particular. tba criteria aboold reflect a
rUattnrflnn between normal aad abnormal
uaaaof rhamlrah.
Aaspones: Tba Agency oooslders that tha
appropriate components of a "substantial
rtaK" with respect to a rhrwilral are (a) tba
seriousness of tba affect, aad (b) total <-xco>
sun potential. Tba outbod tad manner of
uatBf a chemical la one of several factors d»
terminlng Ita expoaura potential Aa de-
scribed la Part 7, tba importance of expo-
sure potential u a rnmprrrmnt of "substan-
Ual risk" depends upesi tba Had of affect of
cottcarn. Thus, tha aff acta daeerlbed la Put
7(a) an so sarioua tha* relatively Uttla
weight la gtvea to eapuaurst tba (fleets de-
i ta Puts 7 (b) aad (o) tatolre a sit*
Tba Agenry farther umliWis that a M>.
of "normal" uae for a partWular
win oftaa depend upon a kauwt-
of tba iwb laanristad with tba
aawemnwmai
OoaoMsf Mr Informs Um published la
eehwaflr literature tn lanynacra other tbaa
g"TlljS should ba exempted If published la
aouaary form by abatncUag aerrtcea. Caa
tba accuracy of	'*"r*r* abetracta
aad eommerdal translations of foreign lit-
tfltBJI bl *'11111"**
Aasystur Tbla policy ititawmt aov po>
v^aa tbu iBfomaaoa publlabad Id sdao-
tlfta UUntura, vbatbar la Tft^tiah or aa-
otbar taacuaca. la axaopttroiB reporting If
pubHahed la summary form by oartala
9fctfled iMnct MntMi
Cbmauist U; mfonuttoo axebaaca in-
tens vttb other Paderal acasdea should ba
tmmertlsleiy wtshltihed so that reapooi.Wmta
aaad not report to SPA lafonaadoa already
reported to other Ajeadeai aad vice rena.
Such dupUcattra reports ara uaduly burdea-
IPA la orwcTftnsrtnr tbK
vttb other acendes turn. Wbaa thla
imnwHnatlnii la mnreesftilly iwmplsteil. Uta
poUey manaent will bar sraended ta »r*
froa the reportiai raqutnmaat tnformsnoa
that baa been submitted to other spectged
•caadea. la the meantime, subataattal-rtak
lafenattoa most ba reported dftetly to
CPA: such a report does aot dtaebarve aajr
rapartlac ohlUartnn to other t
Cmsieu tlr Tba taaaa of tba »«rb "ob-
talar rusaala tbat Hetloa Ha) was la tended
to ba applied pnapacttraly to taforaaOoo
aswiy aeouind afur Jaauary L UTT. Otllisa
sentlaa Ml or other rule* to sequin l&tar-
matioBobuiBwlbttora thao.
Asspeoer Aa aarusssil la tba preamble to
the Sspteaber ( proposal, the Agency ooo-
4den secttoa Wt) u apply to rtak iafora*>
noa posasssm by or kaoem to a paraoo
before, oo. or after Jaauary U UTT. Coo-
earnlac taformatloa first otitslned before
UTT. thla policy statement eoattauea to re-
quire reportiac of Informatloo received U a
person has been aware of It since Jaauary 1,
1971. for the reasons discussed la tba Sep-
tember 9 preamble.
Commmt tl: The term "awan" la too
niue to be of aay help la respoadtag to
these requlremeata. Slace maay oorporua
ssaployeea are potentially subject to these
requireaenca, aod (lveo uoosrtalaty over
tba extent ta which they ougbt to ba avare
of pr»-19T7 Information, this provldoa tends
to aompel the very file search It waa latend-
ed to aratd. Tba term "aware" should ba
farther (teftiwd. poealbly ta tanaa of actual
fcaowledw.
Jtespoiur Tlta Agency la Part 71S of this
policy statement now tleflnri Cba pre-19T7
iafonnaUosi of whkh a penoa Is enaldered
to be awan.
& coarnariat nrtonuiiDi
Comnunt m EPA should delay guidance
nata procedures are published gofenlag
Um mqmiu of	sobsUtflm
Commmt IS." XPA should treat all submit
item y cenfldntlil until t&t tatfoniUoo it
isnflal
CowsMaf Mr XFA should satasaadoaBy
puhUah aacaoD Ke) noooaa.
Asapoaas to Omwstt U tassk Mr
CPA baa tartnrted a saw Part Z which d»
aalbaa bam ta submit a data of coafldea-
ttsllty aad stataa that aay or ail of the la-
fonntioQ ntotttid wm9 b§ cuimd ts oo^
fldntt^L Soeti lalomAllOB vtQ bt dlidond
by OA asily to tbe etsteat, aad by mesne of
tba prooedamk sa* forth ta 40 CPS Put X
Owmseaf TT. What la the statutory basis
or aaed tor guldaacef What la Its exact
status uader the AdmlalstntlTe Procedure
Act?
JUspoMrTtala poller statement seta forth
CPA's Interpretation at aad policy concern-
ing T9CA antton Mak Aa ta latarpretin
rule aad autaae&t of policy tt la aot subject
to ***• oommiot otrtod tod dilind tife^
U*» data provWoaa of tba AdministmiTe
Procedure Act (1 OAC SMX Although
T3CA doaa aot aaadata a policy statement,
tha Agency of necessity mutt develop tha
criteria which win govern enforcement ao-
tintlea. Tt&da asaortatlocs aad tnnlnaaia
ware among thoaa who ttrsrloualy expreased
Interest ta such a rstananut to gutda their
Ur Oartfy wbetbsr tbaa i»
apety to Hftemtctls pnvtoualy
but no kager maauiaetund, proeaaaad. or
distributed la ooomarea by a parsoa
Aaspouc laformatmr obtaiaed before
lrrr must ba raportad If tha patten haa
been awara of It slace Jaauary L im. u
praam hart by Part TUX. Coacsnilng chemi-
cals which a penoa haa dlscoatlaued naau-
facturtag, nrni-aalm. or dlnnbuoag slace
Jaauary U 1ITT. Inform aft oo obtained
before tba Uae of dtacoatlauaUoa la subject
ta tbaa requirements, it u txpected that
tbo soqulsttloo of Information after that
Uaa will ba alalaal: hovettr. 'h*"11* ¦**.
Uoeal laf omattoa ba aoquHad. It aay trlg-
¦a tbe reporting daaenbart la Pan vm
MrGlartfy tbe — ""*t of *sub-
rtsfe" relative to other riska ad-
by T8CA.
Bespmuc A enhstintisl risk b *•»*** la
ftrt 71a) of this policy statement as a rtak
of oostalden&le ooacera ¦-» of (a) the
seriousness or the effeet, aad (b) the fact or
probability of tta occurrence. As oppoeed' to
other risks addressed by TSCA. economic or
sodal benefits of use. or coats of restricting
use. are not to be conaldered In determining
whether a rlak Is "substantial"
Ctesmnt Jft- To what extant are "uaen"
at cbemlcais subject to these requirements?
JUsponsa; Tba Agency considers that
bsu laduttrtal uaes of tfiamlrals actually
fall within the scope of "processing" chemi-
cals. A manufacturer, processor, or distribu-
tor who obtains substantial-dak-Information
concerning rhemlcils he haadla should ba
aUrt to Um paasUfllty ba aay hava to
report it
OmaieMf JV An
tared, ui nuaei J aad distributed a eoa-
aaroe la small quaaUties solely for purposes
of raesrch aad denlopment jubfeet to
these requlremcnta?
BasponM.* Ia lenenl the Agency oonsld-
ers that much manufacturing, praoesalng,
aad dlttrlbutlon la eomoerce of chemicals
In «man quantltlea solely for purposes of ra-
search aad davelopsnant la oopducted for
•eanmardal puiroaee". *«»<« purposes
would Include tba sale aad dtaalbutloa of
such msrariala. u well as (hair uae by tba
maimfarturer or pinisaur ta aettrtOes (for
product reaeaicb SMl development
aaalug tba femstbOlty aad
safety of using chemicals)	bla or a
dlanfi coauaemal um of such natanaiaar
otben on a larger scale.
As dsoBlbad a Part 7, tha Agency tr**-
en that -aubataatlal rtskT* depend la part
upon aa expoaun potential Tbua. tba o&-
uuiauua at tba effects daaoibed la Part
7(a) presuppoee expoaun to tba chemical
and must ba reported: reporting of the
otbar effects wm depend upon a potential
for significant levels of exposure.
Comment 32 An raw	laterm*-
dlates. aad Inert lagredlents produced or
need ta tha oaaaufactun of a pesticide sub-
ject to TSCA?
Aetponar The Administrator eoailden
that itw msiariils. uuermedlata aad Inert
tagndlanta produced or uaed la tha maau-
facturs of a pesticide are subataaces or mix-
tuna which caa ba ragulated under TSCA.
In aider to bo oooaidered a pertldde. a
snhstsnre must ba Intended for uae u a ps»
tldda. Raw inafensls. tatermedlAtea, and
tasrt tagrodlaots produced or uaed la the
manufacture of a pesticide an aot Chem-
selva regulated uader PI7RA (unlea they
happen to bo peatldda themselves) aad.
thenfore. ara subject to TSCA. Tba pesu-
mui oootb, vm. a, m. sx-nwuoAT, maiq* it» iwi
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nut
i at « CVS ltt.4 st ci
IfRfelUlTtot.
¦mmu wr An Intermedlaiae ana
¦ tn Matter! aoieijr far uaa tn the pruu...
i of t food, food addttiv*. dmc. ooemton.
i mbjeet to TSCA?
Tbo Admlnlatraior eaetUm
am muniiUlUM and cnuma intended
¦Wy tar on In the production of a food,
food addtttve, dree ¦
twtnrtwi (no mulattoo under TSCA. The
daflnttfcw of tbo PPDCA provide tbat
ffwmtnai mhatinra which ut Intaadod for
taa u a oompnaont of a food, food additive,
drafc wnoflc. or dartoa an aamnp
wtUtfn the meantny of mob
Tho TOA oocetdn intanaodlAUa
I to bo nea ooooonenU, Thara-
fore. tflay an iui>)aet to	under
tba moi Any web aubetanoe la excluded
Dn rafulaUoo under TSCA Inaofar u it la
¦ennflj manufactured. processed, or dta>
tributad tn nommarca aolely for uao in the
> ahoold boat Ibt
or let.
14.
option to autanit reporta i
SPA cooaiden that any
Informal Inn to CPA
TSCA. Than who an required to do »
under tecttca Mai an paraooe who manu-
facture. preeaaa. or diatittuu tn oonmoreo
or alstuna. Inrtiirttm
not only buatnaaa entlUaa bat alao auch «n-
ployaaa ta daaotbod In Pin IL In order to
aafihltih that neb panona hare ittachariad
their oWlnMopa. and In order to i
raaponalbia rertrw of the quality of Info
ttoa and the mheranrialtty of rtaka. CPA bo>
Ueraa that aotlOan ihould Identify than-
mtrm. Steaaa 8 will adequately protect
aniployoct from	punuant to
notlflfarinri they hive aado under aecttoo
Uai.
VR Doe.-TS-TOMTUed S-U-T8; fctfl am]
NDCtAl UOtSTB. VOL O, wo. »—TMUMOAY, MAtOt 1«r IW
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APPENDIX L
NEIC REPORT WORKSHEET
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
WORKSHEET SUMMARY
Completed
1.	Inspection Management 	 	
2.	Nature of Facility	 	
3.	§5 General InfarrnQtion 	 	
4.	Bona fide Review	 	
5.	Specific PMN Review	 	
6.	5(e)/5(f) Order 	 	
7.	TME Review	 	
8.	R&D Review	 	
9.	8(a) Level A/8(d)	 	
10. 8(c)/B(e)	 	
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
TSCA SECTION 5/8 WORKSHEET
I. INSPECTION MANAGEMENT (Attach additional information as necessary)
1. Name and Address of Facility: 		
2.	Telephone No.: 	 DUNS No.:
3.	Telephone Contact (Name, Title and Date):
4.	Written Notification (Date): 	 [Exhibit 1]
5.	Date and Time of Inspection: 	
6.	Inspection Team:	(lead)
7.	TSCA Notice of Inspection Issued to (Name, Title):
	 [Exhibit 2]
8.	TSCA ICN Notice Issued to (Name, Title):
	 [Exhibit 3]
9.	Other Company Inspection Participants (Names, Titles):
1.		
2.		
3.		
4.		
5.		
10.	Type of Inspection: 	Routine 	Special Request
Followup
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INSPECTION NO.
FACILITY/CITY
INSPECTION OATE
INSPECTION MANAGEMENT (cont.)
11. Scope of Inspection (List by Federal Register, CAS No. or other
designation):
	Gen. Inv.: 	 	8(a) L(A):
	 Spec. PMN: 	
		_ 8(b)
		_ 8(c)
TMEs: 			8(d)
LVEs: 			8(e):
PEs: 			 Sect. 4:
5(e)/5(f): 			Other:
BFs:	Other:
12.	Walk-through:		Yes 	No
Areas: 	
13.	TSCA Receipt for Samples and Documents Issued to:
(Name and Title)	[Exhibit 4]
TSCA Declaration of CBI Issued to:
(Name and Title) 	[Exhibit 5]
14.	Followup Information Requested:	_^es 	No
Date Received: 	
15.	Remarks:
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INSPECTION NO. 	
FACILITY/CITY 	
INSPECTION DATE	
II. NATURE OF THE FACILITY (Attach additional information as necessary):
1. Facility History, Organization and Corporate Relationship:
2. Scope, Size and Functions of the Facility:
3. Facility Description and Layout:
1
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
III. TSCA §5 GENERAL CHEMICAL INVENTORY COMPLIANCE REVIEW
A. Interviewee(s): 1. 	
2.
B. Chemicals: 	Manufactured	 Imported	Processed	Other
1.	Prepared list of chemicals available by CASR No. 	 Yes 	 No
2.	List verified against company business records: 	 Yes 	 No
What records: 	
3.	Records reviewed in lieu of prepared list (type and dates):
4. Chemicals reviewed on open inventory by 	
via 	
Date search completed: 	
No. unlisted chemicals: 	 (attach list)
Date unlisted chemicals sent to OCM: 	
Date reply: 	
No. chemicals unlisted in conf. inventory: 	
Date followup with facility: 	 (attach copy)
Date reply: 	Status: 	
5. Additional Notes and Remarks:
1
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INSPECTION NO.:
FACILITY/CITY:
INSPECTION DATE:
IV. TSCA §5 BONA FIDE REVIEW:
A.	Interviewee(s): (1) 	
(2) 	
B.	1. EPA Accession No. 	
2.	Name of chemical: 	
3.	CAS Registry No. if known: 	
4.	Date of submission: 	
5.	Oate of response by Agency: 	
6.	Was chemical found on confidential inventory?
If yes, did company commercialize product?
7.	What records were reviewed during inspection? _
8. Remarks:
C. 1.	Was PMN filed for chemical? 	
2.	Date of submission: 	 PMN No.:
3.	Was NOC submitted? 	
4.	Was PMN reviewed during this inspection? 	
5.	Remarks:
1
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
V. SPECIFIC PREMANUFACTURE NOTIFICATION (PMN) COMPLIANCE REVIEW
(One PMN per form)
A.	Interviewees: (1) 	
(2) 	
B.	General Information:
1.	PMN No.: 	 90 day Date:
2.	Advance copy available:
Copy at site:
3.	Chemical Name:
4.	Other Names:
5.	Use at site: 	 Manufacture 	 Import 	 Process
	 R&D		Other
C. Production Compliance:
1. Date of first commercial manufacture or import (circle):
How verified (records reviewed and dates): 	
2. Dates and amounts of R A D Production: (1) 	
Use 	
(2) 	
Use	
(Attach if more than 2 R & D batches)
How verified (records reviewed and dates): 	
NOC Date: 	
_Yes _No
Yes No
1
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
SPECIFIC PREMANUFACTURE NOTIFICATION (PMN) COMPLIANCE REVIEW (cont.)
Mass balance and disposition of R & D material: 	
3.	PMN and R & D records complete as per 40 CFR Part 720.78:
	Yes 	No
Description of PMN records: 	
Description of R & D records: 	
4.	Additional remarks:
2
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
SPECIFIC PREMANUFACTURE NOTIFICATION (PMN) COMPLIANCE REVIEW (cont.)
D. Technical Content
1.	Chemical identity: 	
2.	Monomer verification (for polymers only): 	
3.	Impurities: 	
4.	By-products: 	
5.	Use(s): 	
6.	Operation: 	
7.	Exposure: 	
8.	Env. Release: 	
9.	Processing: 	
10.	Test data: 	
11.	Additional Information:
3
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INSPECTION NO. .
FACILITY/CITY
INSPECTION DATE
VI. SPECIFIC PMN-§5(e)/5(f) ORDER
A.	Interviewee(s): (1) 	
(2) 	
B.	Compliance Restrictive Elements:
Was PMN chemical in commercial production at time of inspection?
_Yes 	No
1. Testing Trigger
Specified Testing Production Volume Trigger 	
Was a Trigger volume reached?		Yes _No
If yes, when 	
If yes, has prescribed testing been initiated? _Yes _No
If yes, was commercial production stopped? _Yes 	No
Remarks:
Gloves
Was glove testing a requirement?		Yes		No
If yes, was imperviosity testing conducted? 	Yes		No
Was testing conducted by PMN Submitter/
Contractor (circle one)?
Did testing protocol meet Agency guidelines?	_Yes		No
Were gloves demonstrated to be impervious?	_Yes		No
Was glove usage observed?		Yes		No
Remarks:
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
SPECIFIC PMN-§5(e)/5(f) ORDER (cont.)
3. Protective Qevices and Hazard Communication
What were protective clothing requirements?
Were employees observed to be wearing protective clothing as
described in consent order?		Yes _No
Were other protective measures and equipment in use by
employees as described in consent order? _Yes 	No
Describe: 	
Were employees instructed and trained in the proper use of
protective equipment and measures?		Yes _No
How was this documented? 	
Were affected employees notified in training sessions with
respect to the hazards, dangers and concerns of the PNN
chemical?	_Yes _No
Were signed attendance sheets available for review by the
inspector?	_Yes _No
Had all operators received appropriate training? _Yes _No
How verified:
4. Waste Oisposal
What was specified disposal requirement?
Was evidence of proper disposal present? _Yes _No
How verified:		
2
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INSPECTION MO.
FACILITY/CITY
INSPECTION DATE
SPECIFIC PMN-§5(e)/5(f) ORDER (cont.)
5. Label Requirements
What was type size specification?
Actual type size on label: 	
Remarks:		
6. Evidence for Customer Compliance
Was there evidence of customer compliance with Agency
restrictions on use as described in manufacturer's letter
to final users?		Yes 	No
Remarks:
7. General (Cleanliness and Housekeeping)
Was the production area of PMN Chemical clean and well-
maintained?	_Yes 	No
Was there any evidence of spillage or environmental release?
_Yes 	No
Remarks:
3
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
VII. TSCA §5 TEST MARKETING EXEMPTION
A.	Interviewees: (1) 	
(2) 	
B.	General
1.	TME No.: 	 Date of Receipt:
2.	Chemical: 	
CASR No.: 	
Verification of Chemical Structure:
C. Restrictions
1. Period of Approved Use: 	 to
Verified via:
2. Production Volume Allowed: 	Actual
Verified via:
3. Number of Customers: Allowed: 	Actual
Verified via:				
1
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
VII. TSCA §5 TEST MARKETING EXEMPTION (cont.)
4. Use: Allowed: 	 Actual
Verified via:
5, Worker/Consumer Exposure: Actual:
Allowed: 	
Verified via:
6. Additional Remarks:
2
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
VIII. TSCA §5 RESEARCH & DEVELOPMENT (R&D)
A. Interviewees: (1)
(2)
B. Background
1.	Does facility conduct TSCA defined R&D activities?
__Yes _No
2.	If not, where is basic R & D conducted for company?
3. Does facility/company have a written TSCA R & 0 policy?
__Yes _No
If yes, does the policy reflect recordkeeping and notifica-
tion requirements that became effective 08/04/86?
__Yes 	No
Does the facility/company routinely submit bona fide
inquiries?	__Yes __No
k Remarks:
1
4/87
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
TSCA §5 RESEARCH & DEVELOPMENT (R & D) (cont.)
Specific R&D Chemicals (one chemical per page)
1. Were any R & D chemicals specifically verified for compliance
with R&D exemptions?	_Yes 	No
a.	Name of chemical: 	
b.	Was chemical produced in a quantity over 100 kg/year?
	Yes 	No
c.	Was recordkeeping complete?	_Yes 	No
What type of records?	
d. Were notifications adequate?		Yes 	No
How verified?
e.	Were "technically qualified individuals" supervising use
of the chemical(s)? _Yes	_No
f.	Were risk reviews adequately documented?
	Yes 	No
g.	Were "prudent Laboratory practices" documented?
	Yes 	No
How documented?
h.	Were disposition records complete?	_Yes 	No
i.	Could a reasonable mass balance be accomplished for
reviewed chemicals?	_Yes _No
j. Did amounts produced exceed R&D requirements?
Yes No
2
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INSPECTION NO. 	
FACILITY/CITY 	
INSPECTION OATE 	
VIII. TSCA §5 RESEARCH & DEVELOPMENT (R & D) (cont.)
k. What was disposition of excess R&D material(s)?
2. Remarks:
3	4/87
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
IX. TSCA §8(a) LEVEL A ANO 8(d) COMPLIANCE REVIEW
A.	Interviewees: (1) 	
(2) 	
B.	§8(a) Level A
1.	Name of Chemical: 	
2.	CAS Registry Number:	
3.	Published Reporting Date for PAIR/CAIR: 	
4.	Corporate fiscal year: 	
5.	Was PAIR/CAIR report submitted? _Yes _No
Date of Submission: 	
6.	What information on PAIR/CAIR report was verified? 	
7. What records were reviewed?
8.	Did records agree with submitted report?
9.	Remarks:
1
4/87
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
IX. TSCA §8(a) LEVEL A AND 8(d) COMPLIANCE REVIEW (cont.)
c.
1.	Published reporting date for 8(d): 	
2.	Was 8(d) report submitted?		Yes __No
Date of Submission: 	
3.	Studies submitted (by title): 	
4. Remarks:
2
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
X. TSCA §8(c)/8(e) COMPLIANCE REVIEW
A. Interviewees: (1)
(2)
B. §8£c)
1.	Did facility have a §8(c) file?	_Yes 	No
Location of file: 	
Contents: (1) Allegations:	_Yes 	No
If yes, how many? 	
(Attach list of chemical(s), processes and effects)
(2)	Copy of the 8(c) regulations?
	Yes 	No
(3)	Copy of company or facility 8(c) policy?
_Yes _No
2.	If allegations were on file, did they appear to represent
unknown effects?	_Yes 	No
Remarks: 	
3.	Were recorded allegations filed correctly and completely?
_Yes 	No
Remar ks: 	
4.	Other records (OSHA, incident files, lawsuits) reviewed for
allegations and findings? 	
1
4/87
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INSPECTION NO.
FACILITY/CITY
INSPECTION DATE
X. Tcri. §8(c)/8(e) COMPLIANCE REVIEW (cont.)
5. Were company officials generally knowledgeable of 8(c)
requirements?		 Yes 	 No
Remarks:
6. Had there been any apparent attempts at employee outreach?
	 Yes 	 No
Remarks:
7. Were fact sheets and other information left with plant
officials?	Yes	No
C. 88(e)
1. Did the facility or company have a §8(e) policy?	Yes _No
Did the facility have an 8(e) file?		Yes __No
Location of file: 	
Has the facility or company made any TSCA §8(e) submittals to
the Agency?		No
List:
Were all 8(e) submissions filed within 15 days?
	Yes 	No
How verified:		
2
4/87
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INSPECTION NO.
FACILITY/CITY
INSPECTION OATE
X. TSCA §8(c)/8(e) COMPLIANCE REVIEW (cont.)
2. Were company officials generally knowledgeable of 8(e)
requirements?	_Yes 	No
Remarks:	___
3. Were other spills or releases reported to
EPA State authority or the Coast Guard in
a timely manner?	_Yes 	No
Remarks:
Have any civil lawsuits been filed against the facility
with respect to health or environmental effects?
_Yes 	No
Remarks:
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