Toxic Substances
Control Act
Inspection Manual
Volume One:
TSCA Base Manual
January, 1980
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TSCA Inspection Manual
Volume One
January, 1980
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4% United States
Environmental Protection
VLI M \ Agency
TSCA Inspection Manual
TRANSMITTAL RECORD
No.
Substance of Transmittal
Details
Date
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Contents
Volume One:
TSCA Base Manual
Contents Page
(Detailed Tables of Contents appear at the beginning
of each chapter.)
Foreword iii
Chapter One; TSCA Overview
1 Introduction 1-1
2 TSCA Synopsis 1-3
3 Glossary 1-7
4 Toxic Substances Control Act 1-11
Chapter Two; The TSCA Inspector
1 Inspection Overview 2-1
2 Inspector Authority 2-7
3 Inspector Responsibilities 2-11
Chapter Three; Inspection Procedures
1 Pre-Inspection Preparation 3-1
2 Entry 3-7
Administrative Warrants 3-11
3 Opening Conference 3-15
4 Sampling and Documentation 3-21
Introduction 3-21
Records Inspection 3-23
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Contents
Contents Page
Inspection Procedures (continued)
Documentary Support 3-31
Physical Samples 3-37
Chain of Custody 3-43
Health and Safety 3-47
5 Closing Conference 3-61
6 Security Measures 3-65
Chapter Four; Post-Inspection Activities
1 Report Preparation 4-1
2 Appearing as a Witness 4-11
Chapter Five: Special Procedures
1 Subpoenas 5-1
Chapter Six: Forms 6-1
Chapter Seven: Data Systems 7-1
Appendix
A Shipping Samples A-l
B Model Warrants B-l
Index X-l
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Foreword
The Toxic Substances Control Act Inspection Manual has been developed to
support inspection personnel in conducting the complex field inspections
that are fundamental to TSCA enforcement. The Manual has been designed
as a series of separate, coordinated volumes to reflect the complexity and
diversity of the TSCA mandate and to accommodate expansion as new rules and
enforcement programs are developed. This format was created to provide a
base manual for general TSCA inspection information and a complementary
series of volumes relating to the specific substances or rules developed
under TSCA.
• Volume One; TSCA Base Manual introduces TSCA and provides
general information relating to the Act. Inspector authori-
ties and responsibilities are discussed along with the ele-
ments and scope of TSCA inspections. Procedures which are
common to all TSCA inspections are outlined in detail: Pre-
Inspection Preparation, Entry, Opening Conference, Records
Inspection, Documentary Support, Sampling, Chain of Custody,
Safety, Closing Conference, and Report Preparation. Special
procedures are listed, and all TSCA forms are presented and
explained. Information is also included on data systems,
warrants, shipping samples, and testifying in court.
• Volume Two: PCB Inspection Manual supplements Volume One and
provides the specific information necessary for conducting a
comprehensive inspection for PCBs. An Enforcement Strategy
details EPA plans for PCB inspection and provides an overview
of the regulation. Inspecting, sampling, and reporting procedures
for PCBs in specific industries is provided. This Volume is
designed for portability and easy on-site reference.
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Foreword
• Volume Three and Ensuing Volumes will be developed as rules
are promulgated and will follow a format similar to Volume
Two. Each will deal with information relating to specific
rules or substances and will complement Volume One.
Objectives of Volume One
The overall aim of the TSCA Inspection Manual is to provide clear,
straightforward information in support of field inspection activities.
The specific objectives incorporated into Volume One are:
• To provide a synopsis of the purpose, scope, and contents of
the Act, and to provide a general overview of the elements of
TSCA inspections, and inspector authorities and responsibili-
ties.
• To provide detailed, standard procedures for inspecting under
TSCA.
• To provide easily accessible inspection information which, in
combination with amy of the substance-specific Volumes, will
form a complete, comprehensive inspection manual.
• To provide a basis for general training of new inspection personnel
on TSCA inspection procedures and policies.
Using the Manual
The Manual format has been designed to present the material clearly
and concisely and to allow the user to quickly locate specific
information.
Volume One is organized into seven chapters, each of which contains
several sections. (Chapter Three is further divided into sub-
sections because of the large amount of material presented.)
Divider tabs separate each chapter; following each tab is a
detailed listing of the chapter contents.
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Foreword
Chapter and Section Numbers
The chapter number is printed at the top left of each page. Section
numbers and titles are located at the top right of each page.
Chapter Four 1 | Report Preparation
Page Numbers
Page numbering is organized by chapter. The first digit of the page number
refers to the chapter, the second to the specific page within that chapter
{e.g., page 3--12 refers to page 12 in Chapter Three).
Headings
The pages in the manual are designed to be easily read. Double-lined main
headings are used instead of cumbersome outline numbers to allow a clean,
clear page with space for notations. Subheadings are underlined, and
listed items are identified by bullets.
Appendix
The Appendix, which provides supplementary details on information dis-
cussed in the chapters, is designed to be expanded as needed. Clear
references to Appendix materials are made at appropriate places in the
chapters.
Index
The detailed, cross-referenced Index is provided to help locate specific
material throughout each Volume of the manual.
The Update System
As revised or additional material is developed for the manual, it will be
distributed to all manual holders. A transmittal form will accompany and
explain these changes. The revised or additional pages will be identical
to the original page, but with added identification at the foot.
TSCA Inspection Manual
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Foreword
TSCA Inspection Manual
Volume One
Page
Revised
(Datel
When revisions entail the addition of pages into the manual (i.e., when
3 pages in the manual are replaced by 5 pages), the additional pages will
be numbered as follows:
Original numbering: 3-3, 3-4, 3-5, 3-6, etc.
Addition of pages: 3-3, 3-4, 3-5a, 3-5b, 3-5c, 3-6, etc.
This system will allow updates to be made quickly and easily and will
avoid disruption of the chapters. New material will be numbered se-
quentially by chapter.
TSCA Inspection Manual vi January, 1980
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2.
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Chapter One
TSCA Overview
Chapter Contents Page
1 Introduction to TSCA
Purpose 1-1
Scope 1-2
Relationship to Other Laws 1-2
EPA Authority and Responsibility 1-2
2 TSCA Synopsis
Testing of Chemicals 1-3
Manufacturing and Processing Notices 1-3
Regulation of Hazardous Chemicals 1-4
Imminent Hazards 1-4
Reporting and Retention of Information 1-4
Relationship to Other Federal Laws 1-4
Research and Development 1-4
Inspections and Subpoenas 1-5
Exports and Imports 1-5
Disclosure of Data 1-5
Prohibited Acts 1-5
Civil and Criminal Penalties 1-6
Specific Enforcement and Seizure 1-6
3 Glossary 1-7
4 Toxic Substances Control Act 1-11
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Chapter One
1
Introduction
The Toxic Substances Control Act, Public Law 94-469, was passed by Congress
in 1976 to "regulate commerce and protect human health and the environment
by requiring testing and necessary use restrictions on certain chemical
substances, and for other purposes." The Act, referred to as "TSCA," is
codified at 15 USC et seg. A copy of the Act is provided in this section
of the manual.
Purpose
TSCA was designed to correct the lack of health and safety information
on chemical substances and mixtures and to prevent unreasonable risk
of injury to health or the environment. Under TSCA the term "chemical
substance" means any organic or inorganic substance of a particular
molecular identity, with certain specific exemptions such as pesticides
and tobacco. The Act states that it is the policy of the United States
that:
• Manufacturers must develop adequate data on the health and
environmental effects of chemical substances;
• Chemical substances presenting health and environmental risks
should be regulated; and
• Regulation should not create unnecessary barriers to tech-
nological innovation.
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Chapter One
1 Introduction
Scope
TSCA authorizes EPA to obtain from industry data on the production, use,
health and environmental effects, and other matters concerning chemical
substances and mixtures. If warranted, EPA may regulate the manufacture,
processing, distribution in commerce, use, and disposal of a chemical
substance.
Relationship to Other Laws
The Act directs the Administrator to use other laws administered by EPA,
such as the Federal Water Pollution Control Act or the Clean Air Act, to
protect against unreasonable risks unless the Administrator determines that
it is in the public interest to protect against such risks under TSCA.
The Administrator may also determine that an unreasonable risk presented
by a chemical may be prevented or sufficiently reduced by action under a
Federal law not administered by EPA.
EPA Authority and Responsibility
The Administrator of EPA is authorized to administer the Act in a
reasonable and prudent manner and to consider the environmental, economic,
and social impact of actions taken under TSCA. Within EPA, the Pesticides
and Toxic Substances Enforcement Division (PTSED) of the Office of
Enforcement is responsible for TSCA enforcement activities.
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Chapter One
2
TSCA Synopsis
TSCA Provisions
The principal sections of the Act authorize testing of chemicals, pre-
manufacture notification for new substances or for significant new uses
of existing substances, regulation of chemicals which pose unreasonable
risk, and requirements for recordkeeping and reporting. The Act also
defines TSCA"s relationship with other Federal laws; authorizes research and
development; and provides specific authorities for inspections and subpoenas,
regulation of exports and imports, and imposition of prohibitions, penalties,
and injunctive relief. It also provides for protection of confidential
business information. These sections are briefly reviewed below, (A
complete copy of the Act is provided in the Appendix to this Section.)
Testing of Chemicals (Section 4)
The Administrator may by regulation require testing of substances or mixtures
suspected to be harmful. Testing and evaluation of such substances may be
required to determine health and environmental effects such as carcinogenesis,
mutagenesis, teratogenesis, chronic toxicity or behavioral disorders causing
cumulative effects, or synergistic effects. The Agency sets and reviews
standards for these tests. Manufacturers and processors may be required to
conduct these tests and/or submit existing data.
Manufacturing and Processing Notices (Section 5)
Manufacturers must submit premanufacture notices to EPA 90 days
before manufacturing any new chemical substance or beginning a
significant new use of an existing substance that is not exempt.
Any chemical not listed in the Inventory of Chemicals is con-
sidered "new" under this requirement. The Agency may limit the
production or even ban a substance which EPA feels presents an
unreasonable risk or for which there is not sufficient information
to base a decision regarding environmental and/or health effects.
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Chapter One
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Regulation of Hazardous Chemicals (Section 6)
In cases of potential unreasonable risk of injury to health or the
environment from chemical substances, the Administrator is required to
apply by rule one or more of the following controls:
• Prohibit or limit manufacture and/or processing;
• Impose quality control procedures;
• Prohibit or limit distribution in commerce;
• Prohibit or limit use;
• Require warnings and instructions by labeling or other means;
• Regulate manner of disposal.
Imminent Hazards (Section 7)
EPA may ask the appropriate U.S. district court for a seizure and/or
other immediate relief when a chemical substance is found to pose an
imminent danger.
Reporting and Retention of Information (Section 8)
The Agency may require submission of records and maintenance of records
and reports necessary for the effective implementation of the Act.
Under the Act, EPA is required to compile and maintain an inventory of
each chemical substance manufactured or processed in the United States.
The initial Inventory of Chemical Substances was published June 1, 1979.
Section 8 also requires immediate reporting of any information indicating
that a chemical poses a substantial risk to human health or the environment.
Relationship to Other Federal Laws (Section 9)
Environmental or health risks identified by EPA, but which may be prevented
or reduced by action under a law not administered by EPA, are referred by
report to the appropriate agency. Actions under TSCA are to be coordinated
with other laws administered by EPA. The Agency is required to coordinate
with other Federal agencies for purposes of TSCA enforcement.
Research and Development (Section 10)
EPA may, in consultation with other agencies, conduct or support
research, development, and monitoring to carry out the purposes
of the Act.
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Chapter One
2 TSCA Synopsis
Inspections and Subpoenas (Section 11)
TSCA authorizes, upon presentation of proper credentials and notice,
inspection of establishments, facilities, and premises where chemical
substances are manufactured, processed, stored, held, or conveyed.
Inspection extends to all things within the premises that bear on the Act.
Financial, sales, pricing, personnel, or research data may not be inspected
unless specified in the Notice of Inspection. EPA may subpoena witnesses
and documents.
Exports and Imports (Sections 12 and 13)
TSCA authorizes the regulation of a chemical intended for export only if
it presents an unreasonable risk to health or the environment of the
United States. Records and reports requirements of Section 8 apply to
exports. EPA is responsible for notifying the governments of importing
countries of any regulatory restrictions.
Imported chemical substances are subject to all requirements of TSCA. The
U.S. Treasury Department (U.S. Customs Service) is responsible for
establishing, in cooperation with EPA, procedures to ensure compliance.
Disclosure of Data (Section 14)
Section 14 of TSCA provides for protection of any confidential
business information obtained under the Act, including data obtained
during an inspection. The manufacturer, processor, or distributor
may designate information meeting specified criteria. Willful
disclosure of confidential business information by EPA employees is
subject to criminal penalty.
Prohibited Acts (Section 15)
It is unlawful to:
• Fail or refuse to comply with rules, orders, and/or
requirements under Sections 4, 5, or 6.
• Use for commercial purposes substances manufactured in
violation of Sections 5, 6, or 7.
• Fail or refuse to establish or maintain records or
submit reports.
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Chapter One
Civil and Criminal Penalties (Section 16)
Any person who violates Section 15 is subject to a civil penalty of up to
$25,000 per day per violation. Any person who knowingly or willfully
violates Section 15 may receive a criminal fine of up to $25,000 per day
per violation and/or be imprisoned for up to one year.
Specific Enforcement and Seizure (Section 17)
EPA can request the U.S. district court to take action to compel com-
pliance with or restrain a violation of any provision of the Act or
rules under the Act.
EPA may also ask for seizure or condemnation of a chemical substance which
has been manufactured, processed, or distributed in commerce in violation
of the Act or rule or order under the Act.
2 TSCA Synopsis
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Chapter One
3
Glossary
Act
When used in this manual the word Act means the Toxic
Substances Control Act (TSCA).
Administrator
This term means the Administrator of the Environmental
Protection Agency, or any representative to whom the
Administrator may delegate his authority to carry out
his functions.
Agency
Unless otherwise specified, Agency means the United
States Environmental Protection Agency (EPA).
Byproduct
Chemical
Substance
A byproduct is a chemical substance produced without
separate commercial intent during the manufacture or
processing of another substance or mixture.
Under the Act, a chemical substance is any organic or
inorganic substance or any combination of such substances
occurring as a result of a chemical reaction or occurring
in nature. The term does not include:
Any mixture;
Any pesticide (as defined in the Federal Insecticide,
Fungicide, and Rodenticide Act) when manufactured,
processed, or distributed in commerce for use as a
pesticide;
Tobacco or any tobacco product;
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3 Glossary
Any source material, special nuclear material, or
byproduct material (as such terms are defined in
the Atomic Energy Act of 1954 and regulations issued
under such Act);
Any article the sale of which is subject to the tax
imposed by Section 4181 of the Internal Revenue Code
of 1954 (determined without regard to any exemptions
from such tax provided by Section 4182 or 4221 or any
other provision of such Code); and
Any food, food additive, drug, cosmetic, or device
(as such terms are defined in Section 201 of the
Federal Food, Drug, and Cosmetic Act) when manufactured,
processed, or distributed in commerce for use as a
food, additive, drug, cosmetic, or device.
Commerce
In the Act, commerce refers to trade, traffic, trans-
portation, or other commerce (1) between a place in a
State and any place outside of such State, or (2) which
affects trade, traffic, transportation, or commerce.
Complainant In this manual, complainant refers to the Agency acting
through any person authorized by the Administrator to
issue a complaint to persons alleged to be in violation
of the Act.
Disposal
In this manual, disposal means to intentionally or
accidentally discard, throw away, eliminate, or otherwise
complete or terminate the useful life of chemical substances.
Distribute in
Commerce
This term refers to the sale, introduction into commerce,
delivery, or holding of a substance, mixture, or article.
Documentary This term refers to documents which substantiate a sus-
Sample pected violation relating to a chemical substance. A
documentary sample does not include a sample of the sub-
stance itself.
Duplicate
Sample
In this manual, a duplicate sample is a sample taken at
the request of a facility official that is in every
respect the same as the official sample taken by the
inspector.
Environment The environment includes water, air, and land and the
interrelationship which exists among and between water,
air, and land, and all living things.
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Chapter One
3 Glossary
Facility
Health Effects
As defined in the manual, facility means any establishment,
site, or other premises subject to TSCA enforcement
activity.
Terms referring to the health effects of chemical
substances are defined as follows:
• Behavioral Disorder refers to a disturbance of personal
function resulting from exposure to a toxic substance.
• Carei nogene s i s is the property of a substance which
causes cancer.
• Cumulative Effect refers to the accumulation of a
substance within a living organism and the increasingly
pronounced effects with each exposure.
• Mutagenesis refers to the property of a substance that
causes changes in the genetic structure of subsequent
generations.
• Synergistic Effect refers to the coordination in action
of the -effects of a toxic substance.
• Teratoganesis refers to the property of a substance
that causes malformations or serious deviations from
the normal type in eribryos or fetuses.
Injunction In this manual, an injunction is a court order requiring
a person to perform or to refrain from a specific action.
Inspector An inspector is a representative of the Environmental
Protection Agency authorized by the Administrator to
conduct inspections, make investigations, collect docu-
ments and samples, and otherwise monitor compliance and
enforce the Act.
Impurity in the Act, impurity refers to a substance which is
unintentionally present with another chemical substance.
Manufacture Manufacture means to produce, manufacture, or import into
the customs territory of the United States.
Mixture A mixture is any combination of two or more chemical
substances if the combination does not occur in nature
and is not, in whole or in part, the result of a chemical
reaction.
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Chapter One
3 Glossary
Person
In this manual, a person is defined as any natural or
judicial person including any individual, corporation,
partnership, or association; any State or political
subdivision thereof; any interstate body; and any
department, agency, or instrumentality of the Federal
Government.
Physical
Sample
Process
Process for
Commercial
Purposes
Physical samples are samples that are representative of
a chemical substance as drawn from a container or as
contained in a medium such as soil or solvent. They
are used to confirm the presence and concentration of
a chemical substance.
Process refers to the preparation of a chemical substance
or mixture, after its maufacture, for distribution in
commerce:
• In the same or in a different physical state than that
in which it was received by the processor; or
• As part of an article containing the chemical substance
or mixture.
As defined in the Act, this means to process (1) for
distribution in commerce, including for test marketing
purposes, or (2) for use as an intermediate.
Processor
A processor is any person who processes a chemical sub-
stance or mixture.
Respondant In the Act, respondant refers to the person or company
responding to a complaint issued by the Agency.
Seizure
In the Act, seizure is the condemnation and taking of
any substance, mixture, or article manufactured, processed,
or distributed in commerce in violation of the Act.
State
This term refers to any State of the United States, the
District of Columbia, the Commonwealth of Puerto Rico,
the Virgin Islands, Guam, the Canal Zone, American Samoa,
the Northern Mariana Islands, or any other territory or
possession of the United States.
Toxicity
United States
Toxicity is the property of a chemical substance or
mixture to cause any adverse physiological effects.
When used in the geographic sense, this term means all
of the States, territories, and possessions of the
United States.
Viscosity
In this manual, viscosity refers to the thickness of a
liquid as measured by its ability to flow freely.
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4
Toxic Substances
Control Act
TOXIC SUBSTANCES CONTROL ACT,
1976: PUBLIC LAW 94-469
An Act
To refoUtt commerce luti protect human braltfa aud the euTlroomrtii lyr
requiring testio| and otcesaar? uw restriction* on certain chemical substancea,
aad for other porpoMft.
Be «* enacted by the Senate and House of Representative* of the
United Statet of America in Cong/eti auembled,
SECTION 1. SHORT TITLE AND TABLE 01* CONTENTS.
This Act may be cited at. the "Tone Substances Control Act".
TABLE OF CONTENTS
Sec. 1 Short title and table of contents.
Sec. 2. Findings, poller, sod Intent.
Sec 3. Definitions.
Her 4 Testing of chemical substances and mixtures
Sec 5. Manufnt.turlng and processing notices
Sec U. Regulation of hazardous chemical substance* and mixtures.
Her 7. Imminent basaxds.
Sec 8- Reporting and retention of Information.
Sec 9 Relationship to other Federal Inn a
Sec. 10 Research, development, collection, dissemination, and utilisation of data.
Her 11 Inspections and subpoenas
Sec 1 -- Export*
Sec 13. Entrr into customs territory of the United Statea
Hec 14 Dlscinxnre of data
Sec IS Prohibited acts.
Sec 16. Penalties
Sw 17 Specific enforcement and seizure
Sec 18. l'reemptlon
Sec 11) Judicial review
Sec. 20 Citizens' dill actions.
Sec 21 ('miens' petitions.
Sec 22. -National defense waiver
8ec 23. Employee protection
Sec 24. Employment effects.
Sec 25 Studies.
Sec 26. Administration of the Act.
Stc -T Development and evaluation of test methods
Sec. 28. State programs '
See 29 Authorisation for appropriations.
dec 30. Annual report
Sec 31 Effective date
SEC L FINDINGS, POLICY, AND INTENT.
(a) Findixus—Tlie Congress finds that—
(1) human beings and the environment are being exposed each
year to a large number of chemical substances and mixtures;
(2) anions the many chemical substances and mixtures which
are constantly being developed and produced, there are some
whose manufacture, processing, distribution in commerce, use, or
disposal may present an unreasonable risk of injury to health or
the environment, and
(3) the effective regulation of interstate commerce in such
chemical substances and mixtures also necessitates the regulation
of intrastate commerce in such chemical substances and mixtures.
(b) Pouct.—It is t he policy of the Tj n ited St ates that—
(1) adequate data Bhould be developed w ith respect to the effect
of chemical substances and mixtures on health and the environ-
ment and that the development of such data should be the respon-
sibility of those who manufacture unci those who piocess such
chemical substances and mixtures,
(¦2) adequate authority should exist to regulate chemical sub-
stances ana mixtures which present an unreasonable risk of injury
to health or the environment, and to take action with respect to
chemical substances and mixtures which are imminent hazards;
and
(3) authority oiei chemical substances und mixtures should be
exeicised in such a manner as not to impede unduly oi create
tinnecessaiy economic bainers to technological innovation white
fulfilling the pi iniaiy purpose of this Act to assure tlint such rniio-
vution and commerce in such chemical substances and mixtures
do not present an unreasonable nsk of injuiy to health or the
cm ironnient
(c) Intent of Congress—It is the intent of Congress that the
Administrator shall carry out this Act in a reasonable and prudent
iiuinnci, and that the Administiafor shall consider the environmental,
economic, and social impact of nil) action the Administrator tnkes or
jiroposes to take under this Act.
SEC. S. DEFINITIONS.
As used in tlus Act
(1) the term "Administrator"' means the Administrator of the
Environmental Protection Agency.
(2) (A) Except as providett in subparagraph (B), the term "chem-
ical substance" means any organic or inorganic substance of a particu-
lai nioleculai identity, including—
(i) any combination of such -.ubitances oocurung in whole or
in part as a result of a chemical reaction or occurring in nature,
una
(n) any element or uncombined radical.
(H) Sucli term does not include—
(i) any mixture,
(11) any pesticide (as defined in the Federal Insecticide, Fungi-
cide, ana Rodenticide Act) when manufactured, processed, oi
distnbuted in commerce for use as a pesticide,
(in) tobacco or any tobacco product
(iv) nny source material, special nuclear material, or byproduct
material (as such terms are defined in the Atomic Energy Act
of 1954 and insulations issued under such Act),
(v) any article the sale of which is subject to the tax imposed
by section 4181 of the Internal Revenue Code of 1054 (deter-
mined without regard to any exemptions from such tax provided
by section 4182 or 4221 or any other provision of such Code), and
(vi) any food, food additive, drug, cosmetic, or device (as such
term1) are defined in section 201 of the Federnl Food, Drug, and
Cosmetic Act) a lien manufactured, processed or distributed in
commerce for use as a food, food additive, drug, cosmetic, or
device
The term "food"' as used in clause (vi) of this subparagraph includes
poultry and poultry products (as defined in sections 4(e) and 4(f)
of the Poultry Products Inspection Act), meat and meat food prod-
ucts (as defined in section l(j) of the Federal Meat Inspection Act),
and eggs and egg products (as defined in section 4 of the Egg Prod-
ucts Inspection Act)
(3) The term "commerce" means trade, traffic, transportation, or
other commerce (A) between a place in a State and any place outside
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TSCA
of such State, or (B) which affects trade, traffic, transportation, or
commerce described in clause (A).
(4) The tenna "distribute in commerce" and "distribution in com-
merce" when used to describe nn action taken with respect to a chem-
ical substance or mixture or article containing a substance or mixture
mean to sell, or the sale of, the substance, mixture, or article in com-
merce; to introduce or deliver for introduction into commerce, or the
introduction or delivery for introduction into commerce of, the sub-
stance, mixture, or article j or to hold, or the holding of, the substance,
mixture, or article after its introduction into commerce.
(5) The term "eni ironmenf includes writer, air, and land and the
interrelationship which exists anions and between water, air, and land
and all livingthings.
(6) The term "health and safety study1* means any study of any
effect of n chemical substance or mixture on health or the environ-
ment or on both, including underlying data and epidemiological
studies studies of occupational exposure to a chemical substance or
mixture, toxicologic!*), clinical, and ecological studies of a chemical
substance or mixture, and any test performed pursuant to this Act.
(7) The term "'manufacture" means to import into the customs
territory of the United States (as defined in general headnote 2 of
the Tariff Schedules of the United States), produce, or manufacture.
(8) The term "mixture" means any combination of two or more
chemical substances if the combination does not occur in nature and
is not, in whole or in part, the result of a chemical reaction; except
that such term does include any combination which occurs, in whole
or in part, as a result of a chemical reaction if none of the chemical
substances comprising the combination is a new chemical substance
and if the combination could have been manufactured for commer-
cial purposes without a chemical reaction at the time the chemical
substances comprising the combination were combined.
(9) The term "new chemical substance" means any chemical suIh
stance which is not included in the chemical substance list compiled
and published under section 8(b)
(10) The term "process" means the preparation of a chemical sub-
stance or mixture, after its manufacture, for distribution in
commerce—
(A) in the same form or physical state as, or in a different
form or physical state from, tnat in which it was received by the
person so preparing such substance or mixture, or
(B) as part of an article containing the chemical subetance
or mixture.
(11) The term "processor" means any person who processes a chemi-
cal substance or mixture.
(12) The term "standards for the development of test data" means
* prescription of—
(A) the—
l) health and environmental effects, and
u) information relating to toxicity, persistence, and other
characteristics which affect health and the environment,
for which test data for a chemical substance or mixture are to
be developed and any analysis that is to be performed on such
data, and
(B) to the extent necessary to assure that data respecting such
effects and characteristics are reliable and adequate—
(i) the manner in which such data are to be developed,
ui) the specification of any test protocol or methodology
to be employed in the development of such data, and
(m) such other requirements as are necessary to provide
such assurance.
(13) The term '"State" means nny State of tlie United States, the
District of Columbia, the Commonwealth ol Puerto Rico, the Virgin
Islands, Guam, the Canal iione, American Samoa, the Xoitliem
Mariana Islands, or any other territory or possession of the Uuited
States.
(14) The term ''United Statesuhen used in the geographic sense,
means all of the States.
SEC 4. TESTING OP CHEMICAL SUBSTANCES AND MIXTURES.
(a) Testing liiyi lai jients.—If the Administrator finds that—
(l)(A)(i) the manufacture, distribution in commerce, proc-
essing, use, or disposnI nf j chemical substance or muture, or tiiat
any combination of such actuates, may present an unreasonable
nslt of injury to health or the environmeut,
(ii) there are insufficient tint a and experience upon nlnch the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combina-
tion of such activities on health or the environment can reason-
ably be dctermmed or predicted, and
(in) testing of such substance or mixture with respect to such
effects is necessary to develop such data; or
(B) (l) a cheniicul substance or mixture is or will be produced
in substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or ma\ be significant or substantial human exposure
to such substance or mixture,
(n) there are insufficient data and experience upon nInch the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substnnce or muture or of any combina-
tion of such activities on health or the em ironment can reason-
ably be determined or predicted, and
(in) testing of such substance or mixture with respect to such
effects is necessary to develop such data; and
(2) in the case of a mixture, the effects which the mixture's
manufacture, distribution in commerce, processing, use, or dis-
posal or any combination of such activities may have on health or
the environment may not be reasonably and more efficiently deter-
mined or predicted oy testing the chemical substances nhich com-
piise the mixture;
the Administrator sliall by rule require that testing be conducted on
such substance or mixture to develop data with respect to the health
and environmental effects for uhicli there is nn insufficiency of data
and expeilence and nhich are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal
of such substance or mixture, oi that any combination of such activities,
does or does not present an unreasonable risk of injury to health or
the environment
(b) (1) Testixo Requirement Rule.—A rule under subsection (a)
shall include—
(A) identification of the chemical substance or mixture for
nhich testing is required under the rule,
(B) standards tor the development of test data for such sub-
stance or mixture, and
(C) with respect to chemical substances which are not new
chemical substances and to mixtures, a specification of the period
(which period may not be of unreasonable duration) within
which the persons required to conduct the testing shall submit to
the Administrator data developed in accordance with the stand-
aids referred to m subparagraph (B).
In determining the standards and period to be included^ pursuant to
subparagraphs (B) and (C), in a rule under subEection (a), the
Administrator's considerations shall include the relative costs of the
various teat protocols and methodologies which may be required under
the rale ana the reasonably foreseeable availability of the facilities
and personnel needed to perform the testing required under the rule.
Any such rule may require the submission to the Administrator of pre-
liminary data during the period prescribed under subparagraph (C).
(2) (A) The health and environmental effects lor which standards
for the development of test data may be prescribed include carcino-
genesis, mutagenesis, teratogenesis, behavioral disorders, cumulative
or synergistic effects, and any other effect which maypresent an unrea-
sonable risk of injury to health or the environment. The characteristics
of chemical substances and mixtures for which such standanls may
be prescribed include persistence, acute toxicity, subacute toxicity,
chronic toxicity, and any other characteristic which may present such
a nsk. The methodologies that may be prescribed in such standards
include epidemiologic studies, serial or hierarchical tests, in \ itro tests,
and whole animal tests, except that before prescribing epidemiologic
studies of employees, the Administrator shall consult with the Director
of the National Institute for Occupational Safety and Health.
(H) From time to time, but not less than once each 12 months, the
Administrator shall re\iew the adequacy of the standards for develop-
ment of data prescribed in rules under subsection (a) and shall, if
necessary, institute proceedings to make appropriate revisions of such
standards.
(3) (A) A rule under subsection (a) respecting a chemical substance
or mixture shall require the persons described in subparagraph (B)
to conduct tests ana submit data to the Administrator on such sub-
stance or mixture, except that the Administrator may permit two or
more of such persons to designate one such person or a qualified third
party to conduct such tests and submit such data on behalf of the per-
sons making the designation.
(B) The following persons shall be required to conduct tests and
submit data on a chemical substance or mixture subject to a rule under
subsection (a) -
(i) Each person who manufactures or intends to manufacture
such substance or mixture if the Administrator makes a finding
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described in subsection (1) or (a)(l)(B)(u) with
respect to the manufacture of such substance or mixture.
(ii) Each person who processes or intends to process such sub-
stance or mixture if the Administrator mokes a finding described
in subsection (a)(l)(A)(u) or (a)(1)(B)(n) with respect to
the processing of auch substance or mixture.
(tn) Each person who manufactures or processes or intends to
manufacture or process such substance or mixture if the Adminis-
trator makes# finding described in subsection fa) (1) (A) (ii( or
(a)(1) (B) (n) with respect to the distribution in commerce, use.
or disposal of such substance or mixture
(4) Any rule under subsection (a) requiring the testing of and
submission of data for a particular chemical substance or mixture
shall expire at the end of the reimbursement period (as defined in sub-
section (c)(3) (B)) nhich is applicable to test data for such substance
or nurture unless the Administrator repeals the rule before such date;
and a rule under subsection (a) requiring the testing of and submission
of data for a category of chfflnical substances or mixtures shall expire
with respect to a chemical substance or mixture included in the cate-
gory at the end of thj reimbursement period (as so defined) which if
applicable to test data for such substance or mixture unless the Admin-
istrator before such date repeals the application of the rule to such
substance or mixture or repeals the rule.
(5) linles issued under subsection (a) (and any substantive amend-
ment thereto or repeal thereof) shall be promulgated pursuant to
section 3M of title A, United States Code, except that (A) the Admin-
istrator shall give interested persons an opportunity for the ornl pres-
entation of data, news, or arguments, in edition to an opportunity to
make written submissions, (B) a transcript shall be made of any oral
presentation, and (C) the Administrator shall make and publish with
the nile the findiiup described in paragraph (1)(A) or (1)(B) of
subsection (a) and, in the case of a rule respecting a mixture, the
finding described in paragraph (2) of such suWction.
(c) Exemption-—(l) Any person required by a rule under subsec-
tion (a) to conduct tests and submit data on a chemical substance or
mixture may apply to the Administrator (Ln such form and manner
as the Administrator shall prescribe) for an exemption from such
requirement.
4-2] If. upon receipt of in application under paragraph (I), the
Administrator determines that—
-
stnnre or mixture for which ds.U has been, submitted to the Admin-
istrator m accordance with a rule under Biibsection (a) or for
which data is being developed pursuant to such a rule, and
(B) submission of dita oy the applicant on such substance or
mixture would be duplicative of data which has been submitted
to the Administrator in accordance with such rule or which is
being de\eloped pursuant to such rule,
the Adiiiuiustrntiir shall exempt, in accordance with paragraph (3)
or (4), the applicant from conducting tests and submitting data on
Buch substance or mixture under the rule with respect to which such
nppticotion vros submitted.
(3) (A) If the exemption under paragraph (2) of any person from
the requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the existence of previ-
ously submitted test data and if such exemption is granted during the
reimbursement period for such test data (as prescribed bv subpara-
graph (B)), then (unless such person and the persons referred to in
clauses (i) and (ii) agree on the amount and method of reimburse-
ment ) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount deter-
mined under rules of the Administrator)—
(i) to the person who previously submitted such test data, for
a portion of the costs incurred by such person in complying with
the requirement to submit such data, and
(n) to any other person who has been required under this sub-
paragraph to contribute with respect to such costs. for a portion
of the amount such person was required to contribute.
In promulgating rules for the determination of fair and equitable
reimburse merit to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance or mixture, the
Administrator shall, after consultation with the Attorney General
and the Federal Trade Commission, consider all relevant factors,
including the effect on the competitive position of the person required
to provide reimbursement in relation to the person to be reimbursed
and the share of the market for such substance or mixture of the per-
son required to provide reimbursement in relation to the share of such
market of the persons to be reimbursed. An order under this sub-
paragraph shall, for purposes of judicial review, be considered final
agency action.
(B) For purposes of subparagraph (A), the reimbursement period
for any test data for a chemical substance or mixture is a period—
(l) beginning on tha date such data is submitted m accordance
with a rule promulgated under subsection (a), and
(n) ending—
(I) fire years after the date referred to in clause (l), or
(II) at the expiration of a penod which begins on the date
referred to in clause (i) ana which is equal to the penod
which the Administrator determines was necessary to develop
such data,
whichever is later.
{4) (A) If tftB exemption under paragraph {2) of any person from
the requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the fact that test data
is being developed by one or more persons pursuant to a rule promul-
gated under subsection (a), then (unless such person and the persons
referred to in clauses (l) and (n) agree on the amount and method
of reimbursement) the Administrator shall order the person granted
the exemption to provide fair and equitable reimbursement (in an
amount determined under rules of the Administrator)—
(i) to each such person who is developing such test data, for a
portion of the coats incurred by each such person in complying
with such rule, and
(n) to any other person who has been required under this sub-
paragraph to contribute with respect to the costs of complying
with such rale, for a portion of the amount such person was
required to contribute.
In promulgating rules for the determination of fair and equitable
reimbursement to the persons described in clauses (i) and (ii) for
costs incurred with respect to a chemical substance or mixture, the
Administrator shall, after consultation with the Attorney General and
the Federal Trade Commission, consider the factors described in the
second sentence of paragraph (3) (A). Ad order under this subpara-
graph shall, for purposes of judicial revie w, be considered final agency
action.
(B) If any exemption a granted under paragraph (2) on the basis
of the fact that one. or more persons are dei-eloping test dot a pursuant
to a rule promulgated under subsection (a) and :f after such exemp-
tion is granted the Adm.ntstmlcr determines that no such. person has
complied with suc.li rule, the Administrator shall [i) after providing
written notice to the person who holds such exemption and an oppor-
tunity for a hearing, by order terminate such exemption, ana (n)
notify in writing such person of the requirements of the rule with
respect to which such exemption was granted.
(d) Notice.—Upon the receipt of any test data pursuant to a rule
under subsection (a), the Administrator shall publish a notice of the
receipt of such data m the Federal Register within IS days of its
receipt. Subject to section 14, each such notice shall (1) identify the
chemical substance or mixture for which data hare been received,
(2) list the uses or intended uses of such substance or mixture and the
information required In the applicable standards for the
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or mixture on health or the environment,
(vu) the extent to which testing of the substance or mixture
may rcult in Hie development of data upon which the effects of
the sulfetance or mixture on health or tne environment can rea-
sonably bo determined or predicted, and
(nil) the reasonably foreseeable availnbility of facilities and
personnel for pei forming testing on the substance or mixture.
The ivcotiimcndutmns of the committee shall he in Hie form of n list
of cheimc-iil substances and mixtures n Inch shall be set forth, either by
mdit i\ subparagraph (A) together with the reasons for the
committee's inclusion of each chemical substance or mixture on the list.
At least e\erv six months after the dale of the transmission to the Ad-
, ininistrntor of the list pursuant to the preceeding sentence, the cnmiiut-
' tee shall mnke such re* tsions in the list as it determines to be necessary
and shall transmit them to the Administrator together with the coin-
mitteo's reasons for the revisions Upon receipt of any such revision,
the Administrator shall publish in the Federal Register the list with
such revision, the reasons for such revision, and the designations made
under subparagraph (A). The Administrator shall provide reasonable
opportunity to any interested person to file with the Administrator
written comments on the committee's list, any revision of such list
by the committee, and designations made by the committee, and shall
make such comments available to the public. Within the 12-month
period beginning on the date of the first inclusion on the list of a
chemical substance or mixture designated by the committee under sub-
paragraph (A) the Administrator shall with respect to such chemical
substance or mixture either initiate a rulemaking proceeding under
subsection (a) or if such a proceeding is not initiated within such-
period, publish in the Federal Register the Administrator's reason for
not initiating such a proceeding.
(2}(A) The committee established by paragraph (1) (A) shall con-
sist of eight members as follows.
(!) One member appointed by the Administrator from the
Environmental Protection Agency.
(n) One member appointed by the Secretary of Labor from
officers or employees or the Department of Labor engaged in the
Secretary's activities under the Occupational Safety and Health
Act of 1970
(ill) One member apirainted by the Chairman of the Council
on Environmental Quality from the Council or its officers or
employees.
(iv) One member appointed by the Director of the National
Institute for Occupational Safety and Health from officers or
employees of the Institute.
(v) One member appointed by the Director of the National
Institute of Environmental Health Sciences from officers or
employees of the Institute.
(vi) One member appointed by the Director of the National
Cahcer Institute from oncers or employees of the Institute.
(vii) One member appointed by the Director of the National
Science Foundation from officers or employees of the Foundation
(vui) One member appointed by the secretary of Commerce
from officers or employees of the Department of Commerce.
(B) (i) An appointed member may designate an individual to serve
on the committee on the member's behalf Such a designation may be
made only with the approval of the applicable appointing authority
and only if the individual is from the entity from which the member
was appointed.
(n) No individual may serve as a member of the committee for more
than four years in the aggregate. If any member of the committee
leaves the entity from which the member was appointed, such member
may not continue as a member of the committee, and the member's
position shall be considered to be vacant A vacancy in the committee
shall be filled in the same manner in which the original appointment
was made
(111) Initial appointments to the committee shall be made not later
than the 60th day after the effective date of this Act. Not later than
the 90th day after such date the members of the committee shall hold a
meeting for the selection of a chairperson from among their number.
(C) (i) No member of the committee, or designee of such member,
shall accept employment or compensation from any person subject to
any requirement of this Act or of any rule promulgated or order issued
thereunder, for a period of at least 12 months after termination of
service on the committee.
(ii) No person, while serving as a member of the committee, or des-
ignee of such member, may own any stocks or bonds, or have any
pecuniary interest, of substantia] value in any person engaged in the
manufacture, processing, or distribution in commerce of any chemical
substance or mixture subject to any requirement of this Act or of any
rule promulgated or oraer issued thereunder.
(in) The Administrator, acting through attorneys of the Environ-
mental Protection Agency, or the Attorney General may bring an
action in the appropriate district court of the United States to restrain
any violation of this subparagraph.
(D) The Administrator shall provide the committee such admin-
istrative support sen ices as may be necessary to enable the committee
to carry out its function under this subsection.
(f) Required Actions.—Upon the receipt of—
(1) any test data required to be submitted under this Act, or
(2) any other information available to the Administrator,
which indicates to the Administrator that there may be a reasonable
basis to conclude that a chemical substance or mixture presents or will
present a significant risk of senouB or widespread harm to human
oeings from cancer, gene mutations, or birth defects, the Administra-
tor snail, within the 180-day period beginning on the date of the receipt
of such data or information, initiate appropriate action under section
5,6, or 7 to prevent or reduce to a sufficient eitent such risk or publish
in the Federal Register a finding that such nsk is not unreasonable. For
good cause shown the Administrator may extend such period for on
additional period of not more than 90 days. The Administrator shall
publish in the Federal Register notice or any such extension and the
reasons therefor. A finding by the Administrator that a nsk is not
unreasonable shall be considered agency action for purposes of judicial
review under chapter 7 of title 5, United States Code. This subsection
shall not take effect until two years after the effective date of this Act.
(g) PrrmoN fob Standards roa thk Development or Test Data.—
A person intending to manufacture or process a chemical substance
for which notice is required under section 3 (a) and who is not required
under a rule under subsection (a) to conduct tests and submit data
on such substance may petition the Admin.strator to prescribe stand-
ards for the development of test data for suc'i substance. The Admin-
istrator shall by oroer either grant or deny any such petition within
HO days of its receipt. If the petition is granted, the Administrator
shall prescribe such standards for such substance within 75 davs of
the date the petition is granted. If the petition is denied, the Aamin-
istrator shall publish, subject to section 14, in the Federal Register the
reasons for such denial
SEC. 5. MANUFACTURING AND PROCESS IN G NOTICES.
(a) Iff Genehal.—(1) Except as provided in subsection (h), no
person may—
(A) manufacture a new chemical substance on or after the 30th
day after the date on which the Administrator first publishes the
list required by section 8(b), or
(B) manufacture or process any chemical substance for a use
which the Administrator has determined, in accordance with
paragraph (2), is a significant new use,
unless such person submits to the Administrator, at least 90 days before
such manufacture or processing, a notice, m accordance with subsection
(d), of such person's intention to manufacture or process such sub-
stance and such person complies with any applicable requirement of
Bubeection (b).
(2) A determination by the Administrator that a use of a chemical
substance is a significant new use with respect to which notification
is required under paragraph (1) shall be made by a rule promulgated
after a consideration of all relevant factors, including—
(A) the projected volume of manufacturing and processing of
a chemical substance.
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(B) the extent to which a use changes the type or form of
exposure of human beings or the environment to t rhnmir*!
substance,
(C) the extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a
chemical substance, and
(D) the reasonably anticipated manner and methods of manu-
facturing. processing, distribution in commerce, and disposal of
a chemical substance.
(b) Submission of Test Data.—(1) (A) If (1) a person is required
by subsection (a) (1) to submit a notice to the Administrator before
beginning the manufacture or processing of a chemical substance,
ancl (li) such person is required to submit test data for such sub-
stance pursuant to a rule promulgated under section 4 before the
submission of such notice, such person shall Bubmit to the Adminis-
trator such data in accordance with such rule at the time notice is
submitted in accordance with snbeection (a) (1).
(B) If-
(i) a person is required by subsection (a)(1) to submit a
notice to the Administrator, and
(ii) such person has been granted an exemption under section
4(c) from the requirements of a rule promulgated under section
4 before the submission of such notice,
such person may not, before the expiration of the 90 day period which
begins on the ante of the submission in accordance with such rule of
the test data the submission or development of which was the basis
for the exemption, manufacture such substance if such person is
subject to subsection (a)(1)(A) or manufacture or process such
substance for a significant new use if the person is subject to subsection
^(i)1*!^ if a person—
(i) is required by subsection (a) (1) to submit a notice to the
Administrator before beginning the manufacture or processing
of a chemical substance listed under paragraph (4), and
(ii) is not required by a rule promulgated under section 4
before the submission of such notice to submit test data for such
substance,
such person shall submit to the Administrator data prescribed by
subparagraph (B) at the tune notice is submitted m accordance with
subsection (a)(1).
(B) Data submitted pursuant to subparagraph (A) shall be data
which the person submitting the data believes show that—
(i) in the case of a substance with respect to which notice is
required under subsection (a)(1)(A), the manufacture, process-
ing, distribution in commerce, use, and disposal of the chemical
substance or any combination of such activities will not present
an unreasonable risk of injury to health or the environment, or
(ii) in the case of a chemical substance with respect to which
notice is required undBr subsection (a)(1)(B), the intended
significant new use of the chemical substance will not present an
unreasonable risk of miurv to health or the environment.
(8) Data submitted under paragraph (1) or (2) shall be made
available, subject to section 14, for examination by interested persons.
(4)(A)(i) The Administrator may, by rule, compile and keep
current a list of chemical substances with respect to which the
Administrator finds that the manufacture processing, distribution in
commerce, use, or disposal, or any combination of such activities,
presents or may present an unreasonable risk of injury to health or
the environment
(ii) In making a finding under clause (i) that the manufacture,
processing, distribution in commerce, use, or disposal of & chemical
substance or any combination of such activities presents or may present
an unreasonable risk of injury to health or the environment, the
Administrator shall consider all relevant factors, including—
(I) the effects of the chemical substance on health and the
magnitude of human exposure to such substance; and
(II) the effects of the chemical substance on the environment
and the magnitude of environmental exposure to such substance.
(B) The Administrator shall, in prescribing a rule under subpara-
graph (A) which lists any chemical substance, identify those uses,
if any, which the Administrator determines, by rule under subsection
(a)(2), would constitute a significant new use of such substance.
(C) Any rule under subparagraph (A), and any substantive
amendment or repeal of such a rule, shall be promulgated pursuant
to the procedures specified in section 553 of title 5, United States
Code, except that (n the Administrator shall give interested persons
on opportunity for the oral presentation of data, views, or arguments,
in addition to an opportunity to make written submissions, (ii) a
transcript shall be kept of any oral presentation, and (iii) the Admin-
istrator shall make and publish with the rule the finding described
in subparagraph (A).
(c) Extension or Notice Period.—The Administrator may for
good cause extend for additional periods (not to exceed in the aggre-
gate 90 days) the period, prescribed by subsection (a) or (b) before
which the manufacturing or processing of a chemical substance sub-
ject to such subsection may begin. Subject to section 14, such an
extension and the reasons therefor shall be published in the Federal
Register and shall constitute a final agency action subject to judicial
review.
(d) Content or Notice , Publications or the Federal Reoisteb.—
(1) The notice required by subsection (a) shall include—
(A) insofar as known to the person submitting the notice or
insofar as reasonably ascertainable, the information described in
subparagraphs (A), (B), (C), (D), (F), and (0) of section
8(a)(2), and
(B) m such form and manner as the Administrator may pre-
scribe, any test data in the possession or control of the person
giving such notice which are related to the effect of any manu-
facture. processing, distribution in commerce, use, or disposal of
such substance or any article containing such substance, or of any
combination of Buch activities, an health or the environment, and
(C) a description of any other data concerning the environ-
mental and health effects of such substance, insofar as known to
the person making the notice or insofar as reasonably ascertain-
able.
Such a notice shall be nude available, subject to section 14, for exam-
ination by interested persons.
(2) Subject to section 14, not later than five days (excluding Satur-
days, Sundays and legal holidays) after the date of the receipt of a
notice under subsection (a) or of data under subsection (b), the
Administrator shall publish in the Federal Register a notice which—
(A) identifies the chemical substance for which notice or data
has been received;
(B) lists the uses or intended uses of such substance; and
(C) in the case of the receipt of data under subsection (b),
describes the nature of the tests performed on such substance and
anv data which was developed pursuant to subsection (b) or a
rule under section 4.
A notice under this paragraph respecting a chemical substance shall
identify the chemical substance by generic class unless the Administra-
tor determines that more specific identification is required in the
public interest.
(3) At the beginning of each month the Administrator shall pub-
lish a list m the Federal Register of (A) each chemical substance for
which notice has been received under subsection (a) and for which
the notification period prescribed by subsection (a), (W, or (c) has not
expired, and (B) each chemical substance for which such notifica-
tion period has expired since the last publication in the Federal Regis-
ter of such list.
(e) Rmctlatto.v Pe.vdixq Development or Information.—(1) (A)
If the Administrator determines that—
(i) the information available to the Administrator is insuf-
ficient to permit a reasoned evaluation of the health and environ-
mental effects of a chemical substance with respect to which notice
is required by subsection (a); and
(a)(1) in the absence of sufficient information to permit the
Administrator to make such an evaluation, the manufacture,
processing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present on
unreasonable nsk of injury to health or the environment, or
(II) such substance is or will be produced in substantial quan-
tities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or
there is or may be significant or substantial human exposure to the
substance,
the Administrator may issue a proposed order, to take effect on the
expiration of the notification period applicable to the manufacturing
or processing of such substance under Bubsection (a), (b), or (c), to
prohibit or limit the manufacture, processing, distribution in com-
merce, use, or disposal of such substance or to prohibit or limit any
combination of such activitiea
(B) A proposed order may not be issued under subparagraph (A)
respecting a chemical substance (i) later than 45 days before the
expiration of the notification period applicable to the manufacture or
processing of such substance under subsection (a), (b), or (c), and
(ii) unless the Administrator has, on or before the issuance of the
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proposed order, notified, in writing, each manufacturer or processor,
as Hie case may be, of such substance of the determination which
underlies such order.
(C) If a manufacturer or processor of a chemical substance to be
subject to a proposed order issued under subparagraph (A) files with
the Administrator (within the 80-day period beginning on the date
such manufacturer or processor received the notice required by subpar-
agraph (B)(ii)) objections specifying with particularity the provi-
sions of the order deemed objectionable and stating the grounds
therefor, the proposed order shall not take effect
(2)(A)(i) Except as provided in clause (11), if with respect to a
chemical substance with respect to which notice is required by subsec-
tion (a), the Administrator makes the determination described in
paragraph (1) (A) and if—
(I) the Administrator does not issue a proposed order under
paragraph (1) respecting such substance, or
(II) the Administrator issues such an order respecting such
substance but such order does not take effect because objections
wore filed under paragraph (1) (C) with respect to it,
the Administrator, through attorneys of the Environmental Protection
Agency, shall apply to tne United States District Court for the Dis-
trict of Columbia or the United States district court for the judicial
district in which the manufacturer or processor, as the case may be, of
such substance is found, resides, or transacts business for an injunction
to prohibit or limit the manufacture, processing, distribution in com-
merce, use, or disposal of such substance (or to prohibit or limit any
combination of such activities).
(11) If the Administrator issues a proposed order under paragraph
(1) (A) respecting a chemical substance but such order does not take
effect because objections have been filed under paragraph (1) (C) with
respect to it, the Administrator is not required to apply foi an injunc-
tion under clause (l) respecting such substance if the Administrator
determines, on the basis of such objections, that the determinations
undei paragraph (1) (A) may not be made
(B) A district couit of the United States which receives an appli-
cation under subparagraph (A)(i) for an injunction respecting a
chemical substance shall issue such injunction if the qouit finds that—
(i) the information available to the Administrator is insufficient
to permit a reasoned e\aluation of the health and environmental
effects of a chemical substance with respect to which notice is
required by subsection (a), and
(h)(1) in the absence of sufficient information to permit the
Administrator to make such an evaluation, the manufacture, proc-
essing, distribution in commerce, use, or disposal of such
substance, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment, or
(II) such substance is or will be produced in substantial quan-
tities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or
there is or may be significant or substantial human exposure to
the substance
(C) Pending the completion of a proceeding for the issuance of an
injunction unaei subparagraph (B) respecting a chemical substance,
the court may, upon application of the Administrator made through
uttornejs of the Environmental Protection Agency, issue a temporary
restraining order or a preliminary injunction to prohibit the manu-
facture, processing, distribution in commerce, use, or disposal of such
a substance (or any combination of such activities) if the court finds
that the notification penod applicable under subsection (a), (b), or
(c) to the manufacturing or processing of such substance'may expire
before such proceeding can be completed
(D) After the submission to the Administrator of test data sufficient
to evaluate the health and environmental effects of a chemical sub-
stance subject to an injunction issued under subparagraph (B) and
the evaluation of such data by the Administrator, the district court
of the United States which issued such injunction shall, upon petition,
dissolve the injunction unless the Administrator has initiated a pro-
ceeding for the issuance of a rule under section 6(a) respecting the
substance. If such a proceeding has been initiated, such court shall con-
tinue the injunction in effect until the effective date of the rule pro-
mulgated in such proceeding or, if such proceeding is terminated
without the promulgation of a rule, upon the termination of the pro-
ceeding, whichever occurs first.
(f) Protection Aqai.vst Unreasonable Risks.—(1) If the Admin-
istrator finds that there is a reasonable basis to conclude that the manu-
facture, processing, distribution in commerce, use, or disposal of a
chemical substance with respect to which notice is required by subsec-
tion (a), or that any combination of such activities, presents or will
present an unreasonable risk of injury to health or environment before
a rule promulgated under section 6 can protect against such risk, the
Administrator shall, before the expiration of the notification penod
applicable under subsection (a), (b), or (c) to the manufacturing or
processing of such substance, take the action authorized by paragraph
(2) or (3) to the extent necessary to protect against such risk.
(2) The Administrator may issue a proposed rule under section
8(a) to apply to a chemical substance with respect to which a finding
was made under paragraph (1)—
(A) a requirement limiting the amount of such substance
which may be manufactured, processed, or distributed in
commerce,
(B) a requirement described in paragraph (2), (3), (4), (S),
(6),or (7) ofsection6(a),or
(C) any combination of the requirements referred to in sub-
paragraph (B).
Such a proposed rule shall be effective upon its publication in the Fed-
eral Register Section 6(d)(2)(B) shall apply with respect to such
rule.
(3) (A) The Administrator may—
(i) issue a proposed order to prohibit the manufacture, process-
ing, or distribution in commerce of a substance with respect to
which a finding was made under paragraph (1), or
(u) apply, through attorneys of the Environmental Protection
Agency, to the United States District Court for the District of
Columbia or the United States district court for the judicial dis-
trict in which the manufacturer, or processor, as the cose may be,
of such substance, is found, resides, or transacts business for an
injunction to prohibit the manufacture, processing, or distribu-
tion in commerce of such substance
A proposed order issued under clause (l) respecting a chemical
substance shall take effect on the expiration of the notification period
applicoble under subsection (a), (b), or (c) to the manufacture or
processing of such substance
(B) If the district court of the United States to which an applica-
tion has been made under subparagraph (A) (11) finds that there is a
reasonable basis to conclude that the manufacture, processing,
distribution in commerce, use, or disposal of the chemical substance
with respect to which such application was made, or that any combina-
tion of such activities, presents or will present an unreasonable risk
of injury to health or the environment before a rule promulgated
under section 8 can protect against such risk, the court shall issue
an injunction to prohibit the manufacture,processing, or distribution
in commerce of such substance or to prohibit any combination of such
activities
(C) The provisions of subparagraphs (B) and (C) of subsection
(e) (1) shell apply with respect to an order issued under clause (1)
of subparagraph (A), and the provisionsof subparagraph (C) of sub-
section (e) (2) shall apply with respect to an injunction issued under
subparagraph (B)
(D) If the Administrator issues an order pursuant to subpaiagraph
(A)(i) respecting a chemical substance and objections arc filed in
accordance with subsection (e)(1)(C), the Administrator shnll seek
an injunction under subparagraph (A) (n) respecting such substance
unless the Administrator determines, on the basis of such objectioi s,
that such substance does not or mil not present an unreasonable risk
of injury to health or the environment
(g) Statement of Reasons for Not Taki.vo Action —If the
Administrator has not initiated any action under this section or section
6 or 7 to prohibit or limit the manufacture, processing, distribution
in commerce, use, or disposal of a chemical substance, nith respect to
which notification or data is required by subsection (a) (1) (B) or (b),
liefore the expiration of the notification period applicable to the manu-
facturing or processing of such substance, the Administrator shall
publish a statement of the Administrator's reasons for not initiating
such action. Such a statement shall be published in the Federal Reg-
ister before the expiration of such penod. Publication of such state-
ment in accordance with the preceding sentence is not a prerequisite
to the manufacturing or processing of the substance with respect to
which the statement is to bepublished
(h) Exemption's.—(1) The Administrator may, upon application,
exempt any person from any requirement of subsection (a) or (b) to
permit such person to manufacture or process a chemical substBnce
for test marketing purposes—
(A) upon a showing by such person satisfactory to the Admin-
istrator that the manufacture, processing, distribution m
commerce, use, and disposal of such substance, and that anv com-
bination of such activities, for such purposes will not present any
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unreasonable risk of injury to health or the environment, and
(B) under such restrictions as the Administrator considers
appropriate.
(2) (A) The Administrator may, upon application, exempt tiny per-
son from the requirement of subsection (b)(2) to submit data for a
chemical substance If, upon receipt of an application under the pre-
ceding sentence, the Adminis'rntor determines that—
(i) the chemical substance with respect to which such applica-
tion was submitted is eauivalent to a chemical substance for which
data has been submitted to the Administrator as required by sub-
jection (b)(2). and
(11) submission of dnta by the applicant on such substance
would be duplicatee of data which has been submitted to the
Administrator in accordance with Buch subsection,
the Administrator shall exempt the applicant from the requirement
to submit such data on such substance No exemption which is granted
under this subparagraph with respect to the submission of data for a
chemical substance may take effect before the beginning of the reim-
bursement period applicable to such data.
(B) If the Administrator exempts any person, under subpnraoraph
(A), from submitting data required under subsection (b) (2) for a
chemical substance because of the existence of previously submitted
data and if such exemption is granted during the reimbursement period
for such data, then (unless such person and the persons referred to in
clauses (i) and (11) agree on the amount and method of reimbiii-se-
ment) the Administrator shall order the person granted the exemption
to provide fair and equitable reimbursement (in an amount determined
under rules of the Administrator) —
(l) to the person who previously submitted the data on which
the exemption was based. for a portion of the costs incurred by
such person in complying with the requirement under subsection
(b) (2) to submit such data, and
(n) to any other person who has been required under this sub-
paragraph to contribute with respect to such costs, for a portion
of the amount such person was required to contribute
In promulgating rules for the determination of fair and equitable
reimbursement to the |>ersons described in clauses (i) and (n) for
costs incurred with respect to a chemical substance, the Administrator
shall, after consultation with the Attorney General and the Federal
Trade Commission, consider all relet ant factors, including the effect
on the competitive position of the person required to provide reim-
bursement in relation to the persons to be reimbursed and the share of
the market for such substance of the person required to provide reim-
bursement in relation to the share of such market of the persons to be
reimbursed For purposes of judicial review, an order under this
subparagraph shall be considered final agency atlion.
(C) For purposes of this paragraph, the reimbursement jienod for
any previously submitted data for a chemical substance is a period—
(l) beginning on the date of the termination of the prohibition,
imposed under this section, on the manufacture or processing of
such substance by the person who submitted such data to the
Administrator, and
(n) ending—
(I) five years after the date referred to in clause (l), or
(II) at the expiration of a period nlucli begins on the
date referred to in clause (l) and is equal to the period which
the Administrator determines was necessary to develop such
data,
whichever is later
(3) The requirements of subsections (a) and (b) do not apply with
respect to the manufacturing or processing of any chemical sub-
stance nhich is manufactured or processed, or proposed to be manu-
factured or processed, only in small quantities (as defined by the
Administrator by rule) solely for purposes of—
(A) scientific experimentation or analysis, or
(B) chemical research or, or analysis of such substance or
another substance, including such research or analysis for the
development of a product,
if all persons engaged in such experimentation, research, or analysis
for a manufacturer or processor are notified (in such form and manner
as the Administrator may prescribe) of any risk to health which the
manufacturer, processor, or the Administrator has reason to believe
may be associated with such chemical substance.
(4) The Administrator may. upon application and by rule, exempt
the manufacturer of any new chemical substance from al! or part of
the requirements of this section if the Administrator determines that
the manufacture, processing, distribution in commerce, use, or dis-
posal of such chemical substance, or that any combination of such
activities, will not present an unreasonable nsk of injury to health or
the environment. A role promulgated under this paragraph (and any
substantive amendment to, or repeal of, such a rule) shall be promul-
gated in accordance with paragraphs (2) and (3) of section 6(c).
(5) The Administrator inuv, upon application, make the require-
ments of subsections (u) ami (b) inapplicable with respect to the
manufacturing ni processing of any chemical substance (A) which
exists tenipon ih as a result of a chemical reuction in the manufac-
turing oi priKi'Ssmg of a mixture or anothei chemical substance, and
(li) to winch tlu're is no. and mil not be, human or environmental
exposure
(b) Imniedinteh ii|hiii iwoipt of an application under paragraph
(1) or (j) the Administrator slrall publish in the Federal Register
notice of tiie receipt of such triplication The Administrator shall gne
interested [wrsons an opportunity to comment upon any such applica-
tion aiul shall, n ithin 4."> days of its receipt, either approve or deny the
application The Administrator shall publish in the Federal Register
notice of the approval or denial of such an application.
(i) THfin-ition.—For purposes of this section, the terms "manufac-
ture'1 and "piocess'* mean manufactunngor processing for commercial
puqwses
SEC 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND
MIXTURES.
(a) Miipf or Kkoi i.»tiov —If the Administrator finds that there is
a reasonable Imsis to conclude that the manufacture, processing, dis-
ti ihution in lomitierre, use, or disposal of a chemical sulistance or
mixture, or that any combination of such activities, presentB or will
present an unreasonable nsk of injury to health or the environment,
the Administrator shall by rule apply one or more of the following
requirements to such substance or mixture to the extent necessary to
protect adequately against such nsk using the least burdensome
requirements
(1) A requirement (A) prohibiting the manufacturing, process-
ing. or distiibution in commerce of such substance or mixture, or
(B) limiting the amount of such substance or mixture which may
lie manufactured, processed, or distributed in commerce.
(2) A requirement—
(A) prohibiting the manufacture, processing, or distribu-
tion in commerce of such substance or mixture for (i) n
particular use or (u) a particular u<« in a concentration in
excess of a Ie\el specified by the Administrator in the rule
imposing the requirement, or
(B) limiting the amount of such substance or mixture
which may be manufactured, processed, or distributed in
commerce for 0) a particular use or (u) a particular use
in a concentration in excess of a level specified by the
Administrator in the rule imposing the requirement
(3) A requirement that such substance or mixture or any
article containing such substance or mixture be marked with or
accompanied by clear and adequate warnings and instructions
mth respect to its use, distribution in commerce, or disposal or
with respect to any combination of such activities. The form and
content of such warnings and instructions shall be prescribed by
the Administrator.
(4) A requirement that manufacturers and processors of such
substance oi mixture make and retain records of the processes
used to manufacture or process such substance or mixture and
monitor or conduct testa which are reasonable and necessary to
assure compliance with the requirements of any rule applicable
under this subsection.
(5) A requirement prohibiting or otherwise regulating any
manner or method of commercial use of such substance or
mixture
(6) (A) A requirement prohibiting or otherwise regulating any
manner or method of disposal of such substance or mixture, or
of any article containing such substance or mixture, by its manu-
facturer or processor or by any other person who uses, or disposes
of, it for commercial purposes.
(B) A requirement under subparagraph (A) may not require
any person to take any action which would be in Molation of
any taw or requirement of, or in effect for, a State or political
subdivision, and shall require each person subject to it to notify
each State and political subdivision in which a required disposal
may occur of such disposal
(7) A requirement directing manufacturers or processors of
such substance or mixture (A) to give notice of such unreasonable
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risk of injury to distributors in commerce of such substance or
mixture and, to the extent reasonably ascertainable, to other per-
sons in possession of such substance or mixture or exposed to such
substance or mixture, (B) to give public notice of such nak of
injury, and (C) to replace or repurchase 9uch substance or
mixture as elected by the person to which the requirement Is
directed.
Any requirement (or combination of requirements) imposed under
this subsection may be limited in application to specified geographic
areas.
(b) Quality Control.—If the Administrator has a reasonable
basis to conclude that a particular manufacturer or processor 13 manu-
facturing or processing a chemical substance or mixture in & manner
which unintentionally causes the chemical substance or mixture to
present or which will cause it to present an unreasonable risk of
injury to health or the environment—
(1) the Administrator may by order require Buch manufac-
turer or processor to submit a description of the relevant quality
control procedures followed in the manufacturing or processing
of such chemical substance or mixture; and
(2) if the Administrator determines—
(A) that such quality control procedures are inadequate
to prevent the chemical substance or mixture from presenting
such risk of injury, the Administrator may order the manu-
facturer or processor to revise such quality control procedures
to the extent necessary to remedy such inadequacy; or
(B) that the use of such quality control procedures has
resulted in the distribution in commerce of chemical substances
or mixtures which present an unreasonable risk of injury to
health or the environment, the Administrator may order the
manufacturer or processor to (1) give notice of such risk to
processors or distributors in commerce of any such sub-
stance or mixture, or to both, and, to the extent reasonably
ascertainable, to any other person in possession of or exposed
to anv such substance, (n) to give public notice of such risk,
and (111) to provide such replacement or repurchase of any
such substance or mixture as is necessary to adequately pro-
tect health or the environment.
A determination under subparagraph < A'i ot < B) ol paragraph (2)
shall be made on the record after opportunity for hearing in accord-
ance with section J54 of title 8, Unitea States Code. Any manufacturer
or processor subject to a requirement to replace or repurchase a chem-
ical substance or mixture may elect either to replace or repurchase
the substance or mixture and shall take either <;uch action in the man-
ner prescribed by the Administrator
(c) Peomoloation op Subsection- (a) Rules.—(1) In promulgat-
ing any rule under subsection (a) with respect to a chemical substance
or mixture, the Administrator shall consider and publish a statement
with respect to—
(A) the effects of such substance or mixture on health and the
magnitude of the exposure of humun beings to such substance or
mixture,
(B) the effects of such substance or mixture on the environment
and the magnitude of the exposure of the environment to such
substance or mixture,
(C) the benefits of such substance or mixture for various uses
and the availability of substitutes for such uses, and
(D) the reasonably ascertainable economic consequences of the
rule, after consideration of the effect on the national economy,
small business, technological innovation, the environment, and
public health.
If the Administrator determines that a nsk of injury to health or the
environment could be eliminated or reduced to a sufficient extent by
actions taken under another Federal law (or laws) administered in
whole or in part by the Administrator, the Administrator may not
promulgate a rule under subsection (a'i to protect against such risk
of injury unless the Administrator finds, in the Administrator's dis-
cretion, that it is in the public interest to protect againBt such rnk
under this Act. In making such a finding the Adimnistratorshai) con-
sider (1) all relevant aspects of the risk, as determined by the Adminis-
trator in the Administrator's discretion, (11) a comparison of the
estimated costs of complying with actions taken under this Act and
under such law (or laws), and (111) the relative efficiency of actions
under thw Act and under such law (or laws) to protect against such
nsk of injury.
(2) When prescribing a rule muter subsection {a\ the Adminis-
trator shall proceed in accordance u ilh section 513 of title S, United
States Code (without regard to any reference in such section to sec-
tions 959 and 587 of such title), and shall also (A) publish a notice of
proposed rulemaking stating with particularity the reason for the
proposed rule; (B) allow interested persons to submit written data,
views, and arguments, and make all such submissions publicly avail-
able; (C) provide an opportunity for an informal hearing in accord-
ance with paragraph (3); (D) promulgate, if appropriate, a final
rule based on the nutter id the rulemaking record [as denned in section
19(a)), and (El make and publish »ith the rule the finding described
in subsection (a).
(3) Informal hearings required by paragraph (2) (C) shall be con-
ducted by the Administrator in accordance with the following
requirements:
(A) Subject to subparagraph (B), an interested person is
entitled—
(I) to present such person's position orally or by docu-
mentary submissions (or both), and
(II) if the Administrator determines that there are dis-
puted issues of material fact it is necessary to resolve, to
present such rebuttal submissions and to conduct (or hate
conducted under subparagraph (B)(ii)) such crnes-examina-
tion of persons as the Administrator determines (I) to be
appropriate, and (II) to be required for a full and true dis-
closure with respect to such issues.
(B) The Administrator may prescribe such rules and make such
rulings concerning procedures in such hearings to avoid unneces-
sary costs or delay. Such rules or rulings may include (1) the
imposition of reasonable time limits on each interested person's
oral presentations, and (li) requirements that any cross-examina-
tion to which a person may be entitled under subparagraph (A)
be conducted by the Administrator on behalf of that person in such
manner as the Administrator determines (I) to be appropriate,
and (II) to be required for a full and true disclosure with respect
to disputed issues of material fact
(C)(i) Exoept as provided in clause (ii), if a group of persons
each of whom under subparagraphs (A) and (Bj would be
entitled to conduct (or have conducted) cross-examination and
who are determined by the Administrator to have the same or
similar interests in the proceeding cannot ape upon a single
representative of such interests for purposes oferas-examination,
the Administrator may make rules and rulings (I) limiting the
representation of such interest for such purposes, and (II) gov-
erning the manner in which such cross-examination shall be
limited.
(11) When any person who is a member of a group with respect
to which the Administrator has made a determination under
clause (1) is unable to agree upon group representation with the
other members of the group, then such person shall not be denied
under the authority of clause (¦) the opportunity to conduct (or
have conducted) cross-examination as to issues affecting the per-
son's particular interests if (I) the person satisfies the Admin-
istrator that the person has made a reasonable and good faith
effort to reach agreement upon group representation with the
other members of the group and (II) the Administrator deter-
mines that there are substantial and relevant issues which are not
adequately presented by the group representative.
(D) A verbatim transcript shall be taken of any oral presen-
tation made, and cross-examination conducted m any informal
hearing under this subsection. Such transcript shall be available
to the public.
(i)(A) The Administrator may. pursuant to rules prescribed by the
Administrator, provide compensation for reasonable attorneys' fees,
expert witness fees, and other costs of participating in a rulemaking
proceeding for the promulgation of a rule under subsection (a) to
any person—
(1) who represents an interest which would substantially con-
tribute to a fair determination of the issues to be resolved in the
proceeding, and
(u) if—
(I) the economic interest of such person is small in com-
parison to the costs of effective participation in the proceed-
ing by such person, or
(II) such person demonstrates to the satisfaction of the
Administrator that such person does not have sufficient
resources adequately to participate in the proceeding without
compensation under this subparagraph.
In determining for purposes of clause (1) if an interest wilt substan-
tially contribute to a fair determination of the issues to be resolved in
a proceeding, the Administrator shall take into account the number
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and complexity of such issues and the extant to which representation
of such interest will contribute to widespread public participation hi
the proceeding and representation of a fair balance of interests for
the resolution of audi issues.
(B) In determining whether compensation should be provided to
a person under subparagraph (A) and the amount of such compensa-
tion, the Administrator shall take into account the financial burden
which will be incurred by such person m participating in the rule-
making proceeding. The Administrator shall take such action as
may be necessary to ensure that the aggregate amount of compensa-
tion paid under this paragraph in any fiscal year to all persons who,
in rulemaking proceedings in which they receive compensation, are
persona who either—
(I) would be regulated by the proposed rule, or
(II) represent persons wno would be so regulated,
may not exceed 25 per centum of the aggregate amount paid as com-
pensation under this paragraph to all persons in such fiscal year.
(5) Paragraph (1), (2), (8), and (i) of this subsection supply
to tlie promulgation of a rule repealing, or making a substantive
amendment to, a rule promulgated under subsection (a)
(d) Emcnvi Date.—(1) The Administrator shall specify in any
nue under subsection (a) the date on which it shall take effect, which
date shall be as soon as feasible.
(2) (A) The Administrator may declare a proposed rule under sub-
section (a) to be effective upon its publication ui the Federal Register
and until the effective date of final action taken, in accordance with
subparagraph (B), respecting such rule if—
(i) the Administrator determines that—
(I) the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical substance or mixture
subject to such proposed rule or any combination of such
activities is likely to result in an unreasonable risk of serious
or widespread injury to health or the environment before
such effective date; and
(II) making such proposed rule so effective is necessary to
protect the public interest; and
(u) in the case of a proposed rule to prohibit the manufacture,
processing, or distribution of a chemical Bubstance or mixture
because of the risk determined under clause (i)(I), a court has
m an action under section 7 granted relief with respect to such
risk associated with such substance or mixture.
Such a proposed rule which is made so effective shall not, for pur-
poses of judicial review, be considered final agency action.
J(B) If the Administrator makes a proposed^rule effective upon its
ublication in the Federal Register, the Administrator shall, as expe-
itiously as possible, give interested persons prompt notice of such
action, provide reasonable opportunity, in ecooniance with paragraphs
(2) and (3} of subsection (c), for a Keating on such rule, and either
promulgate such rule (as proposed or with modifications) or revoke
¦t; and if such a hearing is requested, the Administrator shall com-
mence the hearing within five days from the date sucb reqnest is made
unless the Administrator and the peraon making the request agree
upon a later data for the hearing to begin, and after the hearing is
concluded the Administrator shall, within ten days of the conclusion
of the hearing, either promulgate such rule (as proposed or with
modifications) or revoke lL
(e) Polt!ChlohinatŁd Blphenyls.—(1) Within six months after
the effective date of this Act the Administrator shall promulgate
rules to—
(A) prescribe methods for the disposal of polychlonnated
biphenyls, and
(B) require polychlonnated biphenyls to be marked with clear
and adequate warnings, and instructions with respect to their
processing, distribution in commerce, use, or disposal or with
respect to any combination of such activities.
Requirements prescribed by ntles under this paragraph shall be con-
sistent mththe requirements of paragraphs (2) and (3).
(2)(A) Except as provided under subparagraph (B), effective one
jear after the effective date of this Act no person may manufacture,
process, or distribute in commerce or use any polychlonnated biphenyl
m any manner other than in a totally enclosed manner.
(B) The Administrator may by rule authorize the manufacture,
processing, distribution ui commerce or use (or any combination of
such activities) of any polychlonnated biphenyl in a manner other than
in a totally enclosed manner if the Administrator finds that such manu-
facture, processing, distribution in commerce, or use (or combination
of such activities) will not present an unreasonable risk of injury to
health oi the environment.
(C) For the purposes of this paragraph, the term "totally enclosed
manner" means any manner nhich will ensure that any exposure of
human beings or tne environment to a pohchlormated biphenyl will
be insignificant as determined by the Administrator by rule.
(3)(A) Except as provided in subparagraphs (B) and (C)—
(i) no person may manufacture any polychlonnated biphenyl
aftertwojears after the effective date of this Act, and
(u) no person may process or distribute ui commerce any poly-
chlonnated biphenyl after two and one-half years after such date.
(B) Any person may petition the Administrator for an exemption
from the requirements of subparagraph (A), and the Administrator
may grant by rule such an exemption if tne Administrator finds
that—
(i) an unreasonable risk of injury to health or environment
would not result, and
(u) good faith efforts have been made to develop a chemical
substance which does not present an unreasonable nsk of injury
to health or the environment and whieh may be substituted for
such polychlonnated biphenyl.
An exemption granted under this subparagraph shall be subject to
such terms and conditions as the Administrator may prescribe and
shall be in effect for such period (but not more than one year from
the date it is granted) as the Administrator may prescribe.
(C) Subparagraph (A) shall not apply to the distribution in com-
merce of any polychlonnated biphenyl if such polychlonnated
biphenyl was sola for purposes other than resale before two and one
half years after the date ot enactment of this Act
(4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be
promulgated in accordance with paragraphs (2), (3), and (4) cf sub-
section (c).
(5) This subsection does not limit the authority of the Adminis-
trator, under any other provision of this Act or any other Federal law,
to take action respecting any polychlonnated biphenyl.
SEC. 7. IMMINENT HAZARDS.
(a) Acrioxs Althorizld \no Rlouhi.d—<1) The Administrator
may commence a nvil action in an appropriate district court of the
United States—
(A) for seuure of an imminently hazardous chemical sub-
stance or mixture oi iui> article rontnining such a substance or
mixture,
(B) for relief (as authorized by subsection (b)) against any
person who manufactures, processes, distributes in commerce, or
lisrs, or disposes nf. uit imminently hazardous chemical substance
in mixture or any article containing such a substance or nur-
ture, or
(C) for both such seizure and relief.
A civil action may lie commenced iihJci tlua paragraph notwith-
standing tlie existence of n rule under section 4, 5, or 8 or an order
under section A, and notwithstanding the pendency of any adminis-
trative or judicial proceeding under nuy [mgi ision of this Act.
(21 If the Administrator has not made a rule under section 6(a)
immediately effective (as authorized by subsection 6(d) (2)(A) (i))
with respect to an imminently hazardous chemical substance or mix-
ture, the Administrator shall commence in a district court of the United
States with respect to such substance or mixture or article containing
such substance or mixture a civil action described in subparagraph
(A), (B),or (C) of paragraph (1).
(b) Rujet Authorized — (1) The district court of the United
States in which an action under subsection (a) is brought shall have
jurisdiction to grant such temporary or permanent relief as may be
necessary to protect health or tne environment from the unreasonable
risk associated niththe chemical substance, mixture, or article involved
in such act ioa
(2) In the case of an action under subsection (a) brought against
a person who manufactures, processes, or distributes in commerce a
chemical substance or mixture or an article containing a chemical sub-
stance or mixture, the relief authorized by paragraph (1) may include
the issuance of a mandatory order requiring (A) in the case of pur-
chasers of such substance, mixture, or article known to the defendant,
notification to such purchasers of the nsk associated with it; (B) pub-
lie notice of such nsk; (C) recall, (D) the replacement or repurchase
of such substance, mixture, or article; or (E) any combination of the
actions described in the preceding clauses.
(3) In the case of an action under subsection (a) against a chemi-
cal substance, mixture^ or article, such substance, mixture, or article
may be proceeded against by process of libel for its seizure and con-
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demnation. Proceedings in such an action shall conform as nearly as
possible to proceedings in rem in admiralty.
(c) Vekde and Consolidation.—(1)(A) An action under subsec-
tion (a) against a person who manufactures, processes, or distributes a
chemical substance or mixture or an article containing a chemical sub-
stanoe or mixture may be brought in the United States District Court
for the District of Columbia or for any judicial district in which any
of the defendants is found, resides, or transacts business; and process
in such an action may be served an a defendant in any other district
in which such defendant resides or may be found. An action under sub-
section (a) against a chemical substance, mixture, or article may be
brought in any United States district court within the jurisdiction of
which the substance, mixture, or article is found.
(B) In determining the judicial district in which an action may be
brought under subsection (a) in instances in which such action ma;
be brought in more than one judicial district, the Administrator shall
take into account the convenience of the parties.
(C) Subpeonas requiring attendance of witnesses in an action
brought under subsection (a) may be served in any judicial district.
(2) Whenever proceedings under subsection (a) involving identi-
cal chemical substances, mixtures, or articles are pending in courts in
two or more judicial districts, they shall be consolidated for trial by
order of any such court upon application reasonably made by any
party in interest, upon notice to all[parties in interest
(d) Action Undeb Section 6.—Where appropriate, concurrently
with the filing of an action under subsection (a) or as soon thereafter
as may be practicable, the Administrator shall initiate a proceeding
for the promulgation of a rule under section 6 (a).
(e) Representation.—Notwithstanding any other provision of law,
in any action under subsection (a), the Administrator may direct
attorneys of the Environmental Protection Agency to appear and
represent the Administrator in such an action
(f) Definition.—For the purposes of subsection (a), the term
"imminently hazardous chemical substance or mixture"' means a chemi-
cal substance or mixture which presents an imminent and unreason-
able risk of serious or widespread injury to hralth or the environment.
Such a risk to health or the environment shall be considered imminent
if it is shown that the manufacture, processing, distribution in com-
merce, use, or disposal of the chemical substance or mixture, or that any
combination of such activities, is likely to result in such injury to
health or the environment before a final rule under section 6 can
protect against such risk.
SEC «. REPORTING AND RETENTION OF INFORMATION.
(a) Refobts.—(1) The Administrator shall promulgate rules
under which—
(A) each person (other than a small manufacturer or proc-
essor) who manufactures or processes or proposes to manufacture
or process a chemical substance (other than a chemical substance
described in subparagraph (B)(u)) shall maintain such rec-
ords, and shall submit to the Administrator such reports, as the
Administrator may reasonably require, and
(1$) each person (other than a small manufacturer or proc-
essor) who manufactures or processes or proposes to manufacture
or process—
(I) a mixture, or
(II) a chemical substance in small quantities (as defined
by the Administrator by rule) solely for purposes of scientific
experimentation or analysis or chemical research on. or
analysis of, such substance or another substance, including
any such research or analysis for the development of a
product,
shall maintain records and submit to the Administrator reports
but only to the extent the Administrator determines the main-
tenance of records or submission of reports, or both, is necessary
forthe effective enforcement of this Act.
The Administrator may not require in a rule promulgated under this
paragraph the maintenance of records or the submission of reports
with respect to changes in the proportions of the components of a
mixture unless the Administrator finds that the maintenance of such
reoords or the submission of such reports, or both, is necessary for
the effective enforcement of this Act For purposes of the compilation
of the list of chemical substances required under subsection (b), the
Administrator shall promulgate roles pursuant to this subsection not
later than 180 days after the effective date of this Act.
(2) The Administrator may require under paragraph (1) mainte-
nance of reoords and reporting with respect to the following insofar
as known to the person making the report or insofar as reasonably
ascertainable:
(A) The oommon or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for
which such a report is required.
(B) The categories or proposed categories of use of each such
substance or mixture.
(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total
amount to be manufactured or processed, the amount manufac-
tured or processed for each of its categories o( use, and reasonable
estimates of the amount to be manufactured or processed for each
of its categories of use or proposed categories of use.
(D) A description of the byproducts resulting from the manu-
facture, processing, use, or disposal of each such substance or
mixture.
(E) All existing data concerning the environmental and health
effects of such substance or mixture.
(F) The number of individuals exposed, and reasonable esti-
mates of the number who will be exposed, to such substance or
mixture in their places of employment and the duration of such
exposure.
(G) In the initial report under paragraph (I) on such substanoe
or mixture, the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in
such manner or method!.
To the extent feasible, the Administrator shall not require under
paragraph (1), any repotting which is unnecessary or duplicative.
(3) (A) (i) The Administrator may by rule require a small manu-
facturer or processor of a chemical substance to submit to the Admin-
istrator such information respecting the chemical substance as the
Administrator may require for publication of the first list of chemi-
cal substances requited by subsection (b).
(li) The Administrator may by rule require a small manufacturer
or processor of a chemical substance or mixture—
(I) subject to a rule proposed or promulgated under section 1,
5(b) (4), or 6, or an order in effect under section 3(e), or
(II) with respect to which relief has been gran tea pursuant to
a civil action brought under section 5 or 7,
to maintain such records on such substance or mixture, and to submit
to the Administrator such reports on such substance or mixture, as
the Administrator may reasonably require. A rule under this clause
requiring reporting may require reporting with respect to the matters
referred to in paragraph (2).
(B) The Administrator, after consultation with the Administrator
of the Small Business Administration, shall by rule prescribe stand-
ards for determining the manufacturers and processors which qualify
as small manufacturers and processors for purposes of thin paragraph
and paragraph (1).
(b) Inventort.—(1) The Administrator shall compile, keep cur-
rent, and publish a list of each chemical substance which is manufac-
tured or processed m the United States. Such list shall at least include
each chemical substanoe which any person reports, under section 5 or
subsection (a) of this section, is manufactured or processed in the"
United States. Such list may not include any chemical substance
which was not manufactured or processed in the United States within
three years before the effective date of the rules promulgated pur-
suant to the lost sentence of subsection (a) (1). In the case of a chemi-
cal substance for which a notice is submitted in accordance with
section 5, such chemical substance shall be included in such list as of
the earliest date (as determined by the Administrator) on which such
substance was manufactured or processed in the United States. The
Administrator shall first publish such a list not later thm 813 days
after the effective date of this Act. The Administrator shall not
in such list any chemical substance which is manufactured or processed
only in small quantities (as defined by the Administrator by rule)
solely for purposes of scientific experimentation or analysis or chemi-
cal research on, or analysis of, such suhstacce or another substance,
including such research or analysis for the development of a product
(2J lo the extent consistent with the purposes of this Act, the
Administrator may, in lieu of listing, pursuant to paragraph (1), a
chemical substance individually, list a category of chemical substances
in which such substance is included.
(c) Bxcokds.—Any person who manufactures, processes, or distrib-
utes in commerce any chemical substance or mixture shall maintain
records of significant adverse reactions to health or the environment,
as determined by the Administrator by rule, alleged to have been
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caused by the substance or mixture. Records of such adverse reactions
to the health of employees shall be retained for a period of 30 years
from the date such reactions were first reported to or known by the
person maintaining such records. Any other record of such adverse
reactions shall be retained for a period of five years from the date
the information contained in the record was first reported to or known
by the person maintaining the record. Records required to be main-
tained under this subsection shall include records or consumer allega-
tions of personal injury or harm to health, reports of occupational
disease or injury, and reports or complaints of injury to the environ-
ment submitted to the manufacturer, processor, or distributor in com-
merce from any source. Upon request of any duly designated
representative of the Administrator, each person who is required to
maintain records under this subsection shall permit the inspection of
such records and shall submit copies of such records.
(d) Health and Safety Studies.—The Administrator shall pro-
mulgate rules under which the Administrator shall require any person
who manufactures, processes, or distributes in commerce or who pro-
poses to manufacture, process, or distribute in commerce any chemical
substance or mixture (or with respect to paragraph (2), any person
who has possession of a study) to submit to the Administrator—
(1) lists of health ana safety studies (A J conducted or initiated
by or for such person with respect to sucn substance or mixture
at any time, (B) known to such person, or (C) reasonably ascer-
tainable by such person,except that the Administrator may exclude
certain types or categories or studies from the requirements of this
subsection if the Administrator finds that submission of lists of
such studies are unnecessary to carry out the purposes of this Act;
and
(2) copies of any study contained on a list submitted pursuant
to paragraph (1) or otherwise known by such person.
(e) Notice to Administrator of Substantial Risks.—Any person
who manufactures, processes, or distributes m commerce a chemical
substance or mixture and who obtains information which reasonably
supports the conclusion that such substance or mixture presents a
substantial risk of injury to health or the environment shall imme-
diately inform the Administrator of such information unless such
person has actual knowledge that the Administrator has been ade-
quately informed of such information.
(f) Definitions.—For purposes of this section, the terms "manufac-
ture" and "process" mean manufacture or process for commercial
purposes.
SEC 9. RELATIONSHIP TO OTHER FEDERAL LAWS.
(a) Laws Xot Administered bv the Administrator—(1) If
the Administrator has reasonable basis to conclude that the manufac-
ture, processing, distribution in commerce, use, or disposal of a chemical
substance or mixture, or that any combination of such activities, pre-
sents or will present an unreasonable risk of injury to health or the
environment and determines, in the Administrator's discretion, that
such risk may be prevented or reduced to a sufficient extent by action
taken under a Federal law not administered by the Administrator,
the Administrator shall submit to the agency which administers such
law a report which describes such risk and includes in such description
a specification of the activity or combination of activities which the
Vdministrator has reason to believe so presents such risk. Such report
shall also request such agency—
(A)(i) to determine if the risk described in such report may
be prevented or reduced to a sufficient extent by action taken under
such law, and
(li) if the agency determines that such risk may be so prevented
or reduced, to issue an order declaring whether or not the activity
or combination of activities specified in the description of such
risk presents such ri9k, and
(R) to respond to the Administrator with respect to the matters
described in subparagraph (A)
Any report of the Administrator shall include a detailed statement of
the information on which it is based and shall be published in the
Federal Register. The agency receiving a request under such a report
shall make the requested determination, issue the requested order,
and mnke the requested response within such time as the Administrator
specifies in the request, but such time specified may not be less than
90 days from the date the request was made The response of an agency
shall be accompanied by a detailed statement of the findUics and
conclusions of tne agency and shall be published in the Federal Regis-
ter
(2) If the Administrator makes a report under paragraph (1) with
respect to a chemical substance or mixture and the agency to which
such report was made either—
(A) issues an order declaring that the activity or combination
of activities specified in the description of the risk described in
the report does not present the risk described in the report, or
(R) initiates, within 90 days of the publication in the Federal
Register of the response of the agency under paragraph (1), act ion
under the law (or laws) administered by such agency to protect
against such risk associated with such activity or combination of
activities.
the Administrator may not take any action under section 6 or 7 with
respect to such risk.
(3) If the Administrator has initiated action under section B or 7
with respect to a risk associated with a chemical substance or mixture
which was the subject of a report made to an agency under paragraph
(1), such agency shall before taking action under the law (or laws)
administered by it to protect against such risk consult with the Admin-
istrator for the purpose of avoiding duplication of Federal action
against such risk.
(bl Laws Administered by the Administrator.—The Administra-
tor snail coordinate actions taken under this Act with actions taken
under other Federal laws administered in whole or in part by the
Administrator. If the Administrator determines that a risk to health or
the environment associated with a chemical substance or mixture could
be eliminated or reduced to a sufficient extent by actions taken under
the authorities contained in such other Federal laws, the Administrator
shall use such authonties to protect against such risk unless the Admin-
istrator determines, in the Administrator's discretion, that it is in the
public interest to protect against such risk by actions taken under
this Act. This subsection shall not be construed to relieve the Admin-
istrator of any requirement imposed on the Administrator by such
other Federal laws.
(c) Occupational Safety vndHewth.—In exercising any author-
ity under this Act, the Administrator shall not, for purposes of section
4(b)(1) of the Occupational Safety and Health Act of 1970, be
deemed to be exercising statutory authority to prescribe or enforce
standards or regulations affecting occupational safety and health
(d) Coordination—In administering this Act, the Administrator
shall consult and coordinate with the Secretary of Health, Education,
and Welfare and the heads of any other appropriate Federal execu-
tive department or agency, any relevant independent regulatory
agency, and any other appropriate instrumentality of the Federal Gov-
ernment for the purpose of achieving the maximum enforcement of this
Act vhile imposing the least burdens of duplicative requirements on
those subject to the Act and for other purposes. The Administrator
shall, in the report required by section 30, report annually to the
Congress on actions taKen to coordinate with such other Federal
departments, agencies, or instrumentalities, and on actions taken to
coordinate the authority under this Act nith the authonty granted
under other Acts referred to in subsection (b).
SEC 10. RESEARCH. DEVELOPMENT. COLLECTION, DISSEMINATION.
AND UTILIZATION OF DATA.
(a) Acthority.—The Administrator shall. 111 consultation and
cooperation with the Secretory of Health, Education, and Welfare
ana with other heads of appropriate departments and agencies, con-
duct such research, development, and monitoring as is necessary to
carry out the purposes of this Act. The Administrator may enter into
contracts and may make grants for research, development, and moni-
toring under this subsection. Contracts may be entered into under this
subsection without regard to sections 3648 and 3709 of the Revised
Statutes (31 U S.C 329.14 U.S.C S).
(b) Data Systems—(1) The Administrator shall establish, admin-
ister, and be responsible for the continuing activities of an interagency
committee which shall design, establish, and coordinate an efficient ana
effective system, within the Environmental Protection Agency, for
the collection, dissemination to other Federal departments and agen-
cies, and use of data submitted to the Administrator under this Act.
(2) (A) The Administrator shall, in consultation and cooperation
with the Secretary of Health, Education, and Welfare and other heads
of appropriate departments and agencies design, establish, and coordi-
nate an efficient and effective system for the retrieval of toxicological
and other scientific data which could be useful to the Administrator in
carrying ont the purposes of this Act. Systematized retrieval shall be
developed for use by all Federal and other departments and agencies
with responsibilities in the area of regulation or study of chemical
substances and mixtures and their effect on health or the environment.
(B) The Administrator, in consultation and cooperation with the
Secretary of Health, Education, and Welfare, may make grants and
enter into contracts for the development of a data retrieval system
described in subparagraph (A). Contracts may be entered mto under
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this subparagraph without regard to sections 3648 and 3709 of the
Revised Statutes (31 U.S C 529,41 U.S.C. 5).
(c) Scree.vixo Techniques.—The Administrator shall cooidinate,
with the Assistant Secretary for Health of the Department of Health,
Education, and Welfare, research undertaken by the Administrator
and directed to« ard the development of rapid, reliable, and economical
screening techniques for carcinogenic, mutagenic, teratogenic, and
ecological effects of chemical substances and mixtures.
(d) Monitorixo—The Administrator shall, in consultation and
cooperation with the Secretary of Health, Education, and Welfare,
establish and be responsible for research aimed at the development, 'n
cooperation with local, State, and Federal agencies, of monitoring
techniques and instruments nhicli may be used in the detection of toxic
chemical substances and mixtures and which are reliable, economical,
and capable of being implemented under a wide vanety of conditions.
(e) Basic Research.—The Administrator shall, in consultation and
cooperation with the Secretary of Health. Education, and Welfare,
establish research programs to develop the fundamental scientific basis
of the screening and monitoring techniques described m subsections
(c) and (d), the bounds of the reliability of such techniques, and the
opportunities for their improvement.
(f) Training.—The Administrator shall establish and promote
programs and workshops to train or facilitate the training of Federal
laboratory and technical personnel in existing or new ly developed
screening and monitoring techniques.
(g) Exchange op Research and Development Results—The
Administrator shall, in consultation with the Secretary of Health,
Education, and Welfare and other heads of appropriate departments
and agencies, establish and coordinate a system for exchange among
Federal, State, and local authorities of research and development
results respecting toxic chemical substances and mixtures, including
a system to facilitate and promote the development of standard data
format and analysis and consistent testing procedures.
SEC II. INSPECTIONS AND SUBPOENAS.
(a) In General.—For purposes of administering this Act, the
Administrator, and any duly designated representative of the Admin-
istrator, may inspect any establishment, facility, or other premises in
which chemical substances or mixtures are manufactured, processed,
stored, or held before or after their distribution m commerce and any
conveyance being used to transport chemical substances, mixtures, or
such articles m connection with distribution in commerce Such an
inspection may only be made upon the presentation of appropriate
credentials and of a written notice to the owner, operator, or agent in
charge of the premises or conveyance to be inspected. A separate notice
shall be given for each such inspection, but a notice shall not be
required for each entry made dunng the period covered by the inspec-
tion. Each such inspection shall be commenced and completed with
reasonable promptness and shall be conducted at reasonable times,
within reasonable limits, and in a reasonable manner
(b) Scope.—(1) Except as provided in paragraph (2), an inspec-
tion conducted under subsection (a) shall extend to all trungs within
the premises or conveyan<» inspected (including records, files, papers,
processes, controls, and facilities) bearing on whether the requirements
of this Act applicable to the chemical substances or mixtures within
such premises or conveyance have been complied with.
(2) No inspection under subsection (a) shall extend to—
!A) financial data,
B) sales data (other than shipment data),
C) pricing data,
D) personnel data, or
E) research data (other than data required by this Act or
under a rule promulgated thereunder),
unless the nature and extent of such data are described with reasonable
specificity in the written notice required by subsection (a) for such
inspection.
(c) Subpoenas.—In carrying out this Act, the Administrator may
by subpoena require the attendance and testimony of witnesses and
the production of reports, papers, documents, answers to questions,
and other information that the Administrator deems necessary. Wit-
nesses shall be paid the same fees and mileage that are paid witnesses
in the courts of the United States In the event of contumacy, failure,
or refusal of any person to obey any such subpoena, any district court
of the United States in which venue is proper shall have jurisdiction
to order any such person to comply with such subpoena. Any failure
to obey such an oraer of the court is punishable by the court as a con-
tempt thereof.
SEC 11 EXPORTS.
(a) In General.— (1) Except as provided in paragraph (2) and
subsection (b)this Act (other than section 8) shall not apply to any
chemical substance, mixture, or to an article containing a chemical
substance or mixture, if—
(A) it con be shown that such substance, mixture, or article is
being manufactured, processed, or distributed in commerce for
export from the United States, unless such substance, mixture, or
article was, in fact, manufactured, processed, or distributed in
commerce, for use in the United States, and
(B) such substance, mixture, or article (when distributed in
commerce), or any container in which it is enclosed (when SO dis-
tributed), bears a stamp or label stating that such substance, mix-
ture, or article is intended for export
(2) Paragraph (1) shall not apply to any chemical substance, mix-
ture, or article if the Administrator finds that the substance, mixture,
or article will present an unreasonable risk of injury to health within
the United States or to the environment of the United States. The
Administrator may require, under section 4, testing of any chemical
substance or mixture exempted from this Act by paragraph (1) for
the purpose of determining whether or not such substance or mixture
presents an unreasonable risk of injury to health within the United
States or to the environment of the United States.
(b) Notice.— (1) If any person exports or intends to export to a
foreign country a chemical substance or mixture for which the submis-
sion of data is required under section 4 or 5(b), such person shall
notify the Administrator of such exportation or intent to export and
the Administrator shall furnish to the government of such country
notice of the availability of the data submitted to the Administrator
under such section for such substance or mixture.
(2) If any person exports or intends to export to a foreign country
a chemical suutance or mixture for which an order has Seen issued
under section 5 or a rule has been proposed or promulgated under sec-
tion 5 or 6, or with respect to which an action is pending, or relief has
been granted under section 5 or T, such person shall notify the Admin-
istrator of such exportation or intent to export and the Administrator
shall furnish to the government of such country notice of such rule,
order, action, or relief
SEC IX ENTRY INTO CUSTOMS TERRITORY OF THE UNITED STATES.
(a) In General.—(1) The Secretary of the Treasury shall refuse
entry into the customs territory of the United States (as defined in
general head note 2 to the Tariff Schedules of the United States) of
any chemical substance, mixture, or article containing a chemical sub-
stance or mixture offered for such entry if—
(A) it fails to comply with anj rule in effect under this Act, or
(B) it is offered for entry in violation of section 5 or 6, a rule or
order under section 9 or 6, or an order issued in a civil action
brought under section S or 7.
(2) If a chemical substance, mixture, or article is refused entry
under paragraph (1), the Secretary of the Treasury shall notify the
consignee of such entry refusal, shall not release it to the consignee,
and shall cause its disposal or storage (under such rules as the Secre-
tary of the Treasury may prescribe) if it has not been exported by the
consignee within 90 days from the date of receipt of notice of such
refusal, except that the Secretary of the Treasury may, pending a
review by the Administrator of the entry refusal, release to the con-
signee such substance, mixture, or article on execution of bond for the
amount of the full invoice of such substance, mixture, or article (as
such value is set forth in the customs entry), together with the duty
thereon. On failure to return such substance, mixture, or article for
any cause to the custody of the Secretary of the Treasury when
demanded, such consignee shall be liable to the United States for liqui-
dated damages equal to the full amount of such bond. All charges for
storage, cartage, and labor on and for disposal of substances, mixtures,
or articles which are refused entry or release under this section shall
be paid by the owner or consignee, and in default of such payment
shall constitute a hen against any future entry made by such owner or
consignee.
(b) Reus.—The Secretary of the Treasury, after consultation with
the Administrator, shall issue rules for the administration of subsec-
tion (a) of this section.
SEC 14. DISCLOSURE OP DATA.
(a) In General.—Except as provided by subsection (b), any
information reported to. or otherwise obtained by, the Administrator
(or any representative of the Administrator) under this Act, which is
exempt from disclosure pursuant to subsection (a) of section 552 of
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title 5, United States Code, by reason of subsection (b)(4) of such
section, shall, notwithstanding the provisions of any other section of
this Act, not be disclosed by the Administrator or by any officer or
employee of the United States, except that such information—
(1) shall be disclosed to any officer or employee of the United
States—
(A) in connection with the official duties of such officer
or employee under any law for the protection of health or
the environment, or
(B1 for specific law enforcement purposes;
(2) ahall be disclosed to contractors with the United States and
employees of such contractors if in the opinion of the Administra-
tor such disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United StateB entered into
on or after the date of enactment of this Act for the performance
of work in connection with this Act and under such conditions
as the Administrator may specify;
(3) Bhall be disclosed if the Administrator determines it neces-
sary to protect health or the environment against an unreasonable
risk of injury to health or the environment; or
(4) may be disclosed when relevant in any proceeding under
this Act, except that disclosure in such a proceeding shall be
made in such manner as to preserve confidentiality to the extent
practicable without impairing the proceeding.
In any proceeding under section 552(a) of title 5, United States Code,
to obtain information the disclosure of n hich lias been denied because
of the provisions of this subsection, the Administrator may not rely on
rectum 592(b)(3) of such title to sustain the Administrator's action.
(b) Data From Health and Safety Studies.—(1) Subsection (a)
does not prohibit the disclosure of—
(A) any health and safety study which is submitted under this
Act with respect to—
(l) any chemical substance or mixture which, on the date
on which such study is to be disclosed has been offered for
commercial distribution, or
(n) any chemical substance or mirtvre (or which testing is
required under section 4 or for winch notification is required
under section 5, and
(B) any data reported to, or otherwise obtained V>v. the Admin-
istrator from a health and safety study which relates to a chemical
substance or mixture described in clause (l) or (u) of subpara-
graph (A).
This paragraph does not authorise the release of any data w hich dis-
closes processes used in the manufacturing or processing of a chemical
substance or mixture or, in the case of a mixture, the release of data
disclosing the portion of the mixture comprised by any of the chemical
substances in the mixture.
(2) If a request is made to the Administrator under subsection (a)
nf section 552 of title 5, United States Code, for information which is
described in the first sentence of paragraph (1) and which is not
information described in the secona sentence of such paragraph, the
Administrator may not deny such request on the basis of subsection
(b) (4) of such section,
(c) Desiov itiok wo Release of Co.vFiBrjrrnL D »ta—(I| In sub-
mitting data under this Act, a manufacturer, processor, or distributor
in commerce may (A) designate the data which such person believes
is entitled to confidential treatment under subsection (a), and (B)
Bubmit such designated data separately from other data submitted
under this Art A designation under this paragraph shall be made in
writing and in such manner as the Administrator maj prescribe.
(2) (A) Except as provided by subparagraph (B), if the Adminis-
trator proposes to release for inspection data which has been desig-
nated under paragraph (1)(A), the Administrator shall notifv. in
writing and by certified mail, the manufacturer, processor, or distrib-
utor in commerce who submitted such data of the intent to release such
data If the release of such data is to be made pursuant to a request
made under section 5.1-2(a) of title 5, United States Code, such notice
shall be given immediately upon approval of such reauest by the
Administrator The Administrator may not release sucn data until
the expiration of 30 days after the manufacturer, processor, or disti ib-
utor in commerce submitting such data has received the notice required
by r.hw subparagraph.
(B)(i) Subparagraph (A) shall not apply to the release of infor-
mation undei paragraph (1), (2), (3), or (4) of subsection (a),except
that the Administrator may not release data under paragraph (3) of
subsection (a) unless the Administrator has notified each manufac-
turer, processor, and distributor in commerce who submitted such data
of such release Such notice shall be made 15 writing by certified mail
ut least 15 dajs before the release of such data, except that if the
Adimmstratoi determines that the release of such data is necessary
to protect against ail imminent, unreasonable nsk of injury to health
or the enviionment, such notice maj be made by audi means as the
Administrator determines will provide notice at least 24 lioure before
such release is made.
(ii) Subparagraph (A) shall not apply to the release of 1 nformation
described in subsection (b)(1) other than information described in
the second sentence ol such subsection.
(d) Chimtxal Penalty for Wrongful Disclosure—(1) Anj
officer or t-mplovee of the United States or former officer or employee
of the United States, who by virtue of such employment or official
position has obtained possession of, or has access to, material the dis-
closure of winch is prohibited by subsection (a), and who knowing
that disclosure of such material is prohibited by such subsection, will-
fully discloses the material in any manner to any person not entit led to
receive it, shall be guilty of a misdemeanor and fined not more than
$5,000 or imprisoned for not more than one year, or both. Section
1909 of title 18, United States Code, does not apply with respect to
the publishing, divulging, disclosure, or making known of, or making
available, information reported or otherwise obtained under this Act
(2) For the purposes of paragraph (1), any contractor with the
United States who is furnished information as authorized by subsec-
tion (a) (2), and any employee of any such contractor, shall be con-
sidered to be an employee of the United States.
(e) Access bt Coxobzss—Notwithstanding any limitation con-
tained in this section or any other provision of law,, all information
reported to or otherwise obtained bv the Administrator (or any repre-
sentative of the Administrator) under this Act shall be made available,
upon written request of any duly authorized committee of the Con-
gress, to such committee.
SEC. IV PROHIBITED ACTS.
It shall be unlawful for any person to—
(1) fail or refuse to comply with (A) any rule promulgated or
order issued under section 4. (8) anr requirement prescribed by
section 5 or 6t or (C) any pule promulgated or order issued under
section 3 or 6;
(2) use for commercial purposes a chemical substance or mix-
ture which such person knew or had reason to know was manufac-
tured, processed, or distributed in commerce in violation of section
5 or 8, a rule or order under section 5 or fl, or an order issued in
action brought under section 5 or T;
(3) fail or refuse to (A) establish or maintain records, (G)
submit reports, notices, or other information, or (C) permit aoceea
to or copying of records, as required by this Act or a rule there-
under; or
(4) fail or refuse to permit entry or inspection as required by
section 11.
SEC 10. PENALTIES.
(a) Cum-—(1) Any person who violates a provision of section 15
shall be liable to tfie United States for a civil penalty in an amount
not to exceed 525,000 for each such violation. Each day such a viola-
tion continues shall, for purposes of this subsection, constitute a sepa-
rate violation of section 13.
(2) (A) A civil penalty for a violation of section 15 shall be assessed
by the Administrator by an order made on the record after oppor-
tunity (provided in accordance with this subparagraph) for a hearing
in accordance with section 554 of title 5, United States Code. Before
issuing such an order, the Administrator shall mve written notice to
the person to be assessed a civil penalty under such order of the Admin-
istrator's proposal to issue such order and provide such person an
opportunity to request, within 15 days of tlie date the notice is received
by such person, such a hearing on the order.
(B) In determining the amount of a civil penalty, the Administra-
tor shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the violator,
ability to pay, effect on ability to continue to do business, any history
of prioi such violations, the degree of culpability, and sucli othei
matters as justice may require
(C) The Administrator may compromise, modify, or remit, with
or without conditions, any civil penalty winch may be imposed under
this subsection. The amount of such penalty, when finally determined,
or the amount agreed upon in compromise, may be deducted from
any sums owing by the United States to the person charged.
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(3) Any person who requested in accordance with paragraph
(A) a hearing respecting the assessment of a civil penalty and who is
aggrieved by an order assessing a civil penalty may file & petition for
judicial review of such order with the United States Court of Appeals
for the District of Columbia Circuit or for any other circuit in which
such person resides or transacts business. Such a petition may only be
filed within the 30-day period beginning on the date the order malnng
such assessment was issued.
(4) If any person fails to pay an assessment of a civil penalty—
(A) after the -order making the assessment has become a final
order and if such person does not file a petition for judicial review
of the order in accordance with paragraph (3), or
(B) after a court in an action brought under paragraph (3)
has entered a Anal judgment in favor of the Administrator,
the Attorney General shall recover the amount assessed (plus interest
at currently prevailing rates from the date of the expiration of the 30-
day period referred to in paragraph (3) or the date of such final
judgment, as the case may be) in an action brought in any appropriate
district court of the United States. In such an action, the validity,
amount, and appropriateness of such penalty shall not be subject to
review.
(b) Csikivai Any person who knowingly or willfully violates
any provision of section 15 shall, in addition to or in lieu or any civil
penalty which may be imposed under subsection (a) of this section for
such violation, be subject, upon conviction, to a fine of not more than
$25,000 for each day of violation, or to imprisonment for not more
than one year, or both.
SBC 17. SPECIFIC ENFORCEMENT AND SEIZURE.
(a) Specific Ehtobcement.—(1) The district courts of the United
States shall have jurisdiction over civil actions to—
(A) restrain any violation of section 13,
(B) restrain any person from taking any action prohibited by
section 9 or 0 or bv a rule or order under section 6 or 6,
(C) compel the taking of any action required by or under this
Act, or
(D) direct any manufacturer or processor of a chemical sub-
stance or mixture manufactured or processed in violation of sec-
tion J or 0 or a rule or order under section ^ or 8 and distributed
m commerce, (i) to give notice of such fact to distributors in
commerce of such substance or mixture and, to 'he extent reason-
ably ascertainable, to other persons in possession of such sub-
stance or mixture or exposed to such substance or mixture, (11) to
give public notice of such risk of injury, and (m) to either replace
or repurchase such substance or mixture, whichever the person to
which the requirement ts directed electB.
(2) A civil action described in paragraph (1) may he brought—
(A) in the case of a civil action described in subparagraph (A)
of such paragraph, in the United States district court for Ibe judi-
cial district wherein any act, omission, or transaction constituting
a violation of sect ion 1J occurred or wherein the defendant is found
or transacts business, or
(B) in the case of any other civil action described in such para-
graph, in the United States district court for the judicial district
wherein the defendant is found or transacts business.
In any such civil action process may be served on a defendant in any
judicial district ui which a defendant resides or may be found Sub-
poenas requiring attendance of witnesses in any such action may be
served in any judicial district.
(b) Seizube.—Any chemical suhstance or mixture which was manu-
factured, processed, or distributed in commerce in violation of this Act
or any rule promulgated or order issued under this Act or any article
containing such a substance or nurture shall be liable to be proceeded
against, by process of libel for the seizure and condemnation of such
substance, mixture, or article, in any district court of the United States
within the jurisdiction of which such substance, mixture, or article is
found. Such proceedings shall conform as nearly is possible to proceed-
ings in rem in admiralty.
SEC IS. PREEMPTION.
(a) Effect on State Law—(1) Except as provided in paragraph
(2 j, nothing in this Act shall affect the authority of any State or politi-
cal subdivision of a State to establish or continue in effect regulation
of any chemical substance, mixture, or article containing a chemical
substance or mixture.
(2) Except as provided in subsection (b)—
(A) if the Administrator requires by a rule promulgated under
section 1 the testing of a chemical substance or mixture, no State or
political subdivision may, after the effective date of such rule.
establish or continue in effect a requirement for the testing of guch
substance or mixture for purposes similar to those for which test-
ing is required under sucn rule; and
(B) if the Administrator prescribes a rule or order under sec-
tion A or 6 (other than a rule imposing a requirement described
in subsection (a) (6) of section 6) which is applicable to a chemical
substance or mixture, and which is designed to protect against a
risk of injury to health or the environment associated with such
substance or mixture, no State or political subdivision of a State
may, after the effective dote of such requirement, establish or
continue in effect, any requirement which is applicable to such sub-
stance or mixture, or on article containing sucn substance or mix-
ture, and which is designed to protect against such risk unless such
requirement (i) is identical to the requirement prescribed by the
Administrator, (u) is adopted under the authority of the Clean
Air Act or any other Federal law, or (in) prohibits the use of such
substance or mixture in such State or political subdivision (other
than its use in the manufacture or processing of other substances
or mixtures).
(b) Exemption.—Upon application of a State or political subdivi-
sion of & State the Administrator may by rule exempt from subsection
(a) (_2), under such conditions as may be prescribed in such rule, a
requirement of such State or political subdivision designed to protect
against a risk of injury to health or the environment associated with
a chemical substance, mixture, or article containing a chemical sub-
stance or mixture if—
(1) compliance with the requirement would not cause the
manufacturing, processing, distribution in commerce, or use of the
substance, mixture, or article to be in violation of the applicable
requirement under this Act described in subsection (a)(2), and
(2) the State or political subdivision requirement (A) provides
a significantly higher degree of protection from such nsk than the
requirement under this Act described in subsection (a)(2) and
(B) does not, through difficulties in marketing, distribution, or
other factors, unduly burden interstate commerce.
SBC. U. JUDICIAL REVIEW.
(a) In Gemeilm-—(1)(A) Not later than 10 days after the date
of the promulgation of a rule under section 4(a), 5(a)(2), 5(b)(4),
6(a), 0(e), or 8, any person may file a petition for judicial review of
such rule with the United States Court of Appeals for the District of
Columbia Circuit or for the circuit in winch such person resides or in
winch such person's principal place of business is located. Courts
of appeals of the United States shall have exclusive jurisdiction of
any action to obtain judicial review (other than in an enforcement
proceeding) of Buch a rule if any district court of the United States
would have had jurisdiction of such action but for this subparagraph.
(B) Courts oi nppeats of the United States shall hnie exclusive
jurisdiction of any action to obtain judicial rev ten (other than in an
enforcement proceeding) of an order issued under subparagraph (A)
or (B) of section fl(b)(l} if any district court of the United States
would have bad jurisdiction of such action but for this subparagraph.
(2) Copies of nn^ jietition filed under paragraph (I) (A) shall lie
transmitted forthwith to the Administrator and to the Attorney Gen-
eral by the clerk of the court with which such petition was filed The
provisions of section 2112 of title 28, United States Code, shall apply
to the filing of the rulemaking record of proceedings on which the
Administrator liosed the rule being reviewed under this section and to
the transfei of proceedings between United States courts of appeals.
(3) For purposes of this section, the term "rulemaking record"
means—
( A) the rule being reviewed under this section;
(B) in the case of a rule under section 4(a), the finding required
by such section, in the case of & rule under section 5(b) (4). tlio
finding required by such °cction, in the case of a rule under section
0(a) the finding required by section S(f) or 6(a), as the cose may
be, ui the case of a rule under section 6(a), the statement required
by section 6(c) (1), and in the case of a rule under section 6(e),
the findings required by paragraph ,(2) (B) or (3)(B) of such
section, as the case may be;
(C) any transcript resumed to be made of oral presentations
made in proceedings for trie promulgation of such rule;
(D) any written submission of interested parties respecting the
promulgation of such rule; and
(E) any other information which the Administrator considers
to be relevant to such rule and which the Administrator identified,
on or before the date of the promulgation of such rule, in a notice
published in the Federal Register.
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(b) AdDITIOS'AI, StTBMIBSIOS'B AND PRESENTATIONS ; MODIFICATIONS.—
If in an action under this section to review a mte the petitioner or the
Administrator applies to the court for leave to make additional oral
submissions or written presentations respecting such nile and shows
to the satisfaction of the court that such submissions and presentations
would be material and that there were reasonable grounds for the sub-
missions and failure to make such submissions and presentations tn
the proceeding before the Administrator, the court may order the
Administrator to provide additional opportunity to make such sub-
missions and presentations. The Administrator may modify or set
astde the rule being reviewed or make a new rule by reason of the
additional submissions and presentations and shall fife such modified
or new rule with the return of such submissions and presentation^.
The court shall thereafter review such new or modified rule
(c) Standard op Review.—(1) (A) Upon the filing of a petition
under subsection (a) (1) for judicial review r>f a rule, the court shall
have jurisdiction (1) to grant appropriate relief, including interim
relief, as provided in chapter T of title 5, United States Code, and
(li) except as otherwise provided in subparagraph (B), to review
such rule in accordance with chapter 7 of title 5, Lmted States Code.
(B) Section 706 of title 5, United States Code, shall apply to review
of a rule under this section, except that—
(i) in the case of review of a rule under section 4(a), 5(b) (4).
6(a), or 6(e). the standard for review prescribed by paragraph
('2) (E) of such section 708 shall not apply and the court shall
hold unlawful and set aside such rule if the court finds that the
rule is not supported by substantial evidence m the rulemaking
record (as defined in subsection (a) (3)) taken as a whole,
(ii) in the case of review of a rule under section 6(a), the court
shall hold unlawful and 9et aside such rule if it finds that—
(I) a determination by the Administrator under section
6(c) (3) that the petitioner seeking review of such rule is not
entitled to conduct (or have conducted) cross-examination or
to present rebuttal submissions, or
(II) a rule of, or ruling by, the Administrator under sec-
tion 6(c)(3) limiting such petitioner's cross-examination or
oral presentations.
has precluded disclosure of disputed materia] facts which was
necessary to a fair determination by the Administrator of the
rulemaking proceeding taken aa a whole, and section 706(2) (D)
shall not apply with respect to a determination, rule, or ruling
referred to in subclause (I) or (II) ; and
(ill) the court may not review the contents and adequacy of—
(I) any statement required to be made pursuant to section
6(c)(1).or
(II) any statement of basis and purpose required by sec-
tion 553(c) of title 5, United States Coae. to be incorporated
m the rule
except as part of a review of the rulemaking record taken as a
whole.
The term "evidence" as used in clause (1) means any maitor in the
rulemaking record
(C) A determination, rule, or ruling of the Adnnnistiator described
in subparagraph (II) (u) maj be reviewed only in an action under
this section and only in accordance with such subparngiaph
(2) The judgment of tlie court afhiming oi setting aside, in whole
or in pait, any rule reviewed in accordance with this section shall be
final, subject to review by the Supreme Court of the United States
upon certioian or certification, as provided in section 1234 of title 28,
United Slates Code.
(d) Fees and costs.—The decision of the court in an action com-
menced under subsection (a), or of the Supreme Couit of the United
States on review of such a decision, may include an avvai-d of costs of
suit and reasonable fees for attorneys and cxjieit witnesses if the court
determines that sucli an award is appropi late
(e) Other remedies —The remedies as provided in this section shall
be in addition to and not in lieu of any other remedies piovided by law
SEC 20. CITIZENS' CIVIL ACTIONS
(a) In Genulvl.—Except as provided in subsection (b), any person
may commence a civil action—
(1) against any person (including (A) the United States, and
(B) any other governmental instrumentality or agency to the
extent permitted by the eleventh amendment to the Constitution)
who is alleged to be in violation of this Act or any rule promul-
gated under section 4, 5, or 6 or order issued under section 5
to restrain such violation, or
(2) against the Administrator to compel tie Administrator
to perform any act or duty under this Act which is not discre-
tionary
Any civil action under paragraph (1) shall be brought in the United
States district court for the district in which the alleged violation
occurred or ill which the defendant resides or in which the defendant's
principal place of business is located. Any action brought under para-
graph (2) shall be brought in the United States District Court for
the District of Columbia, or the United States district court for the
judicial district in which the plaintiff is domiciled. The distnct courts
of the United States shall have jurisdiction over suits brought under
this section, witliout regard to the amount in controversy or the citizen-
ship of the parties. In any civil action under this subsection process
may be served on a defendant in any judicial district in which the
defendant resides or may be found and subpoenas for witnesses may
be served in any judicial distnct
(b) Limitation.—No civil action may be commenced—
(1) under subsection (a) (1) to restrain a violation of this Act
or rule or order under this Act—
(A) before the expiration of 60 days after the plaintiff
has given notice of such violation (i) to the Administrator,
and (ii) to the person who is alleged to have committed such
violation, or
(B) if the Administrator has commenced and is diligently
prosecuting a proceeding foi the issuance of an order under
section 16(a) (2) to require compliance with this Act or with
such rule or ordei or if the Attorney General has commenced
and is diligently prosecuting a civil action in a court of the
United States to require compliance with this Act or with
such rule or order, but if such proceeding or civil action is
commenced after the giving of notice, any person giving such
notice may intervene as a matter of right in such proceeding
or action; or
(2) under subsection (a) (2) before the expiration of 60 days
after the plaintiff has given notice to the Administrator of the
alleged failure of the Administrator to perform an act or duty
which is the basis for such action or, in the case of an action under
sudi subsection for the failure of the Administrator to file an
action under section 7, before the expiration of ten days after
such notification
Notice under this subsection shall be given in such manner as the
Administrator shall prescribe by rule
(c) Geker-vl.—(1) In nin nctaon under this section, the Adminis-
trator, if not a pnity. may intervene as .i matter of right
(2) The court, in issuing anv final older in nny action brought pur-
suant to subsection (a), may award costs of suit and reasonable fees
for nttomevs nnd expert witnesses if the court determines that sucli
an aword is appropriate Anv court, in issuing its decision in nil action
brought to review such an order, mnv award costs of suit and reason-
able fees for attornejs if the court determines that such an award
is appropriate
(3) Nothing in tlnssection shall restrict any i ight which any person
(or class of persons) may have undei an\ statute or common law to
seek enforcement of this Vet or any rule or order under this Act
or toswk any other relief.
(d) Consolidation —When two or more ci v il actions brought under
subsection (a) involving the same defendant nnd the s^me i<3u<": oi
violations nre pending in two or more judicial districts, such pending
actions, ujKin application of such defendants to such actions which is
made to a court in which anv such action is brought, mav, if such court
in its discretion so decides, be consolidated for trial bv order (issued
after giving all parties reasonable notice and opportunity to be heard)
of such court and tried in—
(1) any district which is selected bv such defendant and in
which one of such actions is pending.
(2) a district which is agreed upon bv stipulation between all
the parties to such actions and in which one of such actions is
pending, or
(3) a distnct which is selected bv the court and in which one
of such actions is pending
The court issuing such an order shall give prompt notification of the
order to the other courts in which the civ it actions consolidated under
the order are pending
SEC 21. CITIZENS' PETITIONS.
(a) In General—Any person may petition the Administrator to
initiate a proceeding for the issuance, amendment, or repeal of a rule
under section 4, 9, or 8 or an order under section 5(e) or (6) (b) (2)
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(b) Phocqiuhxs.—(1) Such petition shall be filed in the principal
office of the Administrator ana shall set forth the facta which it is
claimed establish that it is necessary to issue, amend, or repeal a rule
under section 4, 6, or 8 or an order under section 5(e), 6(t>)(l)(A),
or 6(b)(1)(B).
(2) The Administrator may hold a public hearing or may conduct
such investigation or proceeding as the Administrator deems appro-
priate in order to determine whether or not such petition should be
granted
(3) Within 90 days after filing of a petition described in paragraph
(1), the Administrator shall either grant or deny th* petition. If the
Administrator grants such petition, the Administrator shall promptly
commence an appropriate proceeding in accordance with section 4,
5.0, or 8. If the Administrator denies such petition, the Administrator
snail publish in the Federal Register the Administrator's reasons
for such denial.
(4) (A) If the Administrator denies a petition filed under this
section (or if the Administrator fails to grant or deny such petition
within the 90-day period) the petitioner may commence a civil action
in a district court of the United States to compel the Administrator
to initiate a rulemaking proceeding as requested in the petition. Any
such action shnll be filed within HO days after the Admiiiistrntoi s
denial of the petition or, if the Administrator fails to grant or deny
the petition within 90 dajs nfter filing the petition, uitlun CO days
after the expiration of the 00-dav penod
(B) In an action under subparagraph (A) respecting a petition
to initiate a proceeding to issue n iulc under section 4. 6. or 8 or an
order under section 5(e) or 6(b) (2), the petitioner shall be provided
an opportunity to have such |>etitioii consideied by the court in a
de novo proceeding. It the petitioner demonstrates to the satisfaction
of the court by a preponderance of the e\ idence that—
(l) in the case of a petition to initiate a proceeding for the
issuance of a rule under section 4 or an order under section 5(e) —
(I) information available to the Administrator is insuffi-
cient to permit a reasoned evaluation of the health and
environmental effects of the chemical substance to be subject
to such rule or order, and
(II) in the absence of such information, the substance may
present an unreasonable ri9k to health oi the environment,
or the substance is or «ill be produced in substantial quan-
tities and it enters or may reasonably be anticipated to enter
the environment hi substantial quantities or there is or may
be significant or substantial human exposure to it; oi
(n) in the case of a petition to initiate a proceeding for the
issuance of a rule under section 6 or 8 or an order under section
6(b)(2), there is a reasonable basis to conclude that the issuance
of such a rule or order is necessary to protect health or the
environment against an unreasonable risk of injury to health or
the environment.
the court shall order the Administrator to initiate the action requested
by the petitioner If the court finds that the extent of the risk to
health or the environment alleged bj the petitioner is less than the
extent of risks to health or the environment with respect to which
the Administrator is taking action under this Act and there are
insufficient resources available to the Administrator to take the action
requested bv the petitioner the court may |>ermit the Administrator
to defer initiating the action I'cquested by the petitioner until such time
as the court prescribes.
(C) The court in issuing any final order in any action brought pur-
suant to subparagraph (A) may award costs of suit and reasonable
fees for attorneys and expert witnesses if the court determines that
such an award is appropriate. Any court, in issuing its decision in an
action brought to review such an order, may awani costs of suit and
reasonable fees for attorneys if the court determines that such an
award is appropriate
(5) The remedies under this section shall be in addition to, and not
in lieu of, other remedies provided by law.
SEC It NATIONAL DEFENSE WAIVER.
The Administrator shall waive compliance with any provision of
this Act upon a request and determination by the President that the
requested waiver is necessary in the interest of national defense. The
Administrator shall maintain a written record of the basis upon
which such waiver was granted and make such record available for in
camera examination when relevant in a judicial proceeding under
this Act. Upon the issuance of such a waiver, the Administrator shall
publish in the Federal Register a notice that the waiver was granted
for national defense purposes, unless, upon the request of the Presi-
dent, the Administrator determines to omit such publication because
the publication itself would be contrary to the interests of national
defense, in which event the Administrator shall submit notice thereof
to the Armed Services Committees of the Senate and the House of
Representatives.
SEC. H. EMPLOYEE PROTECTION.
(a) In Ojenebal.—No employer may discharge any employee or
otherwise discriminate against any employee with respect to the
employee's compensation, terms, conditions, or privileges of employ-
ment because the employee (or any person acting pursuant to a request
of the employee) hash-
(1) commenced, caused to be commenced, or is about to com-
mence or cause to be commenced a proceeding under this Act;
(2) testified or is about to testify in any such proceeding; or
(8) assisted or participated or is about to assist or participate
in any manner in such a proceeding or in any other action to
carry out the purposes of this Act.
(b) Remedt.—(1) Any employee who believes that the employee
has been discharged or otherwise discriminated against by any person
in violation of subsection (a) of this section may, within 30 days after
such alleged violation occurs, file (or have any person file on the
employee's behalf) a complaint with the Secretary of Labor (here-
inafter ui this section referred to as the "Secretary") alleging such
discharge or discrimination. Upon receipt of such a complaint, the
Secretary shall notify the person named in the complaint of the filing
of the complaint.
(2) (A) Upon receipt of a complaint filed under paragraph (1), the
Secretary shall conduct an investigation of the violation alleged in the
complaint Withm 30 days of the receipt of such complaint, the Secre-
tary shall complete such investigation and shall notify in writing the
complainant (and any person acting on behalf of the complainant)
and the person alleged to have committed such violation of the results
of the investigation conducted pursuant to this paragraph. Within
ninety days of the receipt of such complaint the Secretary shall, unless
the proceeding on the complaint is terminated by the Secretary on the
basis of a settlement entered into by the Secretary and the person
alleged to have committed such violation, issue an order either pro-
viding the relief prescribed by subparagraph (B) or denying the
complaint An order of the Secretary shalfbe made on the record after
notice and opportunity for agency hearing. The Secretary may not
enter into a settlement terminating a proceeding on a complaint with-
out the participation and consent of the complainant
(B) If in response to a complaint filed under paragraph (1) the
Secretary determines that a violation of subsection (a) of this section
has occurred, the Secretary shall order (i) the person who committed
such violation to take affirmative action to abate the violation, (u)
such person to reinstate the complainant to the complainant's former
position together with the compensation (including back paj), terms,
conditions, and privileges of the complainant's employment, (in) com-
pensatory damages, and (iv) where appropriate, exemplary damages.
If such an order issued, the Secretary, at the request of the complain-
ant, shall assess against the person against whom the order is issued a
sum equal to the aggregate amount ofall costs and expenses (including
attorney's fees) reasonably incurred, as determined oy the Secretary,
bv the complainant for, or in connection with, the bringing of the com-
plaint upon which the order was issued.
(c) Review—(1) Any employee or employer adversely affected or
aggrieved by an order issued under subsection (b) may obtain review
of the order in the United States Court of Appeals for the circuit in
which the wolation. with respect to which the order was issued,
allegedly occurred The petition for re* lew must be filed within sixty
days from the issuance of the Secretary's order. Review shall conform
to chapter 7 of title 5 of the United States Code.
(2) An order of the Secretary, with respect to which review could
ha\e been obtained under paragraph (1), shall not be subject to
judicial review in any criminal or other civil proceeding
(d) Enfortkment —Whenever a person hns failed to comply with
an order issued under subsection (b) (2), the Secretary shall file a civil
action in the United States d'stnet court for the district in which the
violation was found to occur to enforce such order In actions brought
under this subsection, the district courts shall have jurisdiction to
grant all appropriate relief, including injunctive relief and compensa-
tory and exemplary damages On il actions brought under this sub-
section shall be henid and decided expeditiously.
(e) Exclusion —Subsection (a) of this section shall not apply with
respect to any employee who, acting without direction from the
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employee's employer (or any agent of the employer), deliberately
causes a violation of any requirement of this Act.
SEC !4. EMPLOYMENT EFFECTS.
(a) In General.—The Administrator shall evaluate oil a continuing
basis the potential effects on employment (including reductions in
employment or loss of employment from threatened plant closures)
of—
(1) the issuance of n rule or order under section 4, 5, or 6, or
(2) a requirement of section 5 or 6.
(b)(1) ItrvzCTiGATiojfS—Any employee (or any representative of
an employee) may request the Administrator to make an investigation
of—
(A) a discharge or layoff or threatened discharge or layoff of
the employee, or
(B) adverse or threatened adverse effects on the employee's
employment,
allegedly resulting from a rule or order under section 4, 5, or 6 or &
requirement of section 5 or 8. Any such request shall be made in writ-
ing, shall set forth with reasonable particularity the grounds for the
request, and shall be sijrned by the employee, or representative of such
employee, making the request.
(2) (A) Upon receipt of a request made in accordance with para-
graph (1) the Administrator shall (i) conduct the investigation
requested, and (n) if requested by any interested person hold public
hearings on anv matter involved in the investigation unless the Admin-
istrator. by order issued within 45 days of the date such hearings are
requested, denies the request for the hearings because the Adminis-
trator determines there are no reasonable grounds for holding such
hearings. If the Administrator makes such a determination, the
Administrator shall notify in writing the person requesting the hear-
ing of the determination and the reasons therefor and shall publish the
determination and the reasons therefor in the Federal Register.
(B) If public hearings are to be held on any matter involved in an
investigation conducted under this subsection—
(i) at least five days' notice shall be provided the person mak-
ing the request for the investigation ana any person identified in
such request,
(ii) such hearings shall be held in accordance with section
6(c) (3), and
(m) each employee who made or for whom was made a request
for such hearings and the employer of such employee shall be
required to present information respecting the applicable matter
referred to in paragraph (1)(A) or (1) (B) together with the
basis for such information.
(3) Upon completion of an investigation under paragraph (2), the
Administrator shall make findings of fact, shall make such recom-
mendations as the Administrator deems appropriate, and shall make
available to the public such findings and recommendations.
(4) This section shall not be construed to require the Administrator
to amend or repeal any rule or order in effect under this Act.
8EC. 8. STUDIES.
(a) INDEirNOTCAnoN Stodt.—The Administrator shall conduct a
study of all Federal laws administered by the Administrator for the
purpose of determining whether and under what conditions, if any,
indemnification should De accorded any person as a result of any action
taken bv the Administrator under any such law. The study shall—
(1) include an estimate of the probable cost of any indemnifica-
tion programs which may be recommended;
(2 ) include an examination of all viable means of financing the
cost of any recommended indemnification; and
(3} be completed and submitted to Cengress within two years
from the effective date of enactment of this Act
The General Accounting Office shall review the adequacy of the study
submitted to Congress pursuant to paragraph (3) and shall report the
results of its review to the Congress within six months of the date
such study is submitted to Congress.
(b) Classitication, SroaAOE, and Rethieval Stodt.—The Council
on Environmental Quality, in consultation with the Administrator,
the Secretary of Health, Education, and Welfare, the Secretary of
Commerce, and the heads of other appropriate Federal departments or
agencies, shall coordinate a study of the feasibility of establishing (1)
a standard classification system for chemical substances and related
substances, and (2) a standard means for storing and for obtaining
rapid access to information respecting such substances. A report on
such study shall be completed and submitted to Congress not later than
18 months after the effective date of enactment of this Act.
SEC M. ADMINISTRATION OF THE ACT.
(a) Cooperation or Federal Agencies.—Upon request by the
Administrator, each Federal department and agency is authorized—
(1) to make its services, personnel, and facilities available
(with or without reimbursement) to the Administrator to assist
the Administrator in the administration of this Act; and
(2) to fumisli to the Administrator such information, datn,
estimates, and statistics, and to allow the Administrator access to
all information in its possession as the Administrator may reason-
ably determine to be necessary for the administration of this Act.
(b) Fees—(1) The Administrator may, by rule, require the pay-
ment of a reasonable fee from any person required to submit data
under section 4 or 5 to defray the cost of administering this Act. Such
rules shall not provide for any fee in excess of $2,500 or, in the cose of
a small business concern, any fee in excess of $100. In setting a fee
under this paragraph, the Administrator shall take into account the
ability to pay of the person required to submit the data and the cost
to the Administrator of reviewing such dnta Such rules tuny provide
for sharing such a fee in any case in which the expenses of testing are
shared under section 4 or 5.
(2) The Administrator, after consultation with the Administrator
of the Small Business Administration, shall bv rule prescribe stand-
ards for determining the persons which qualify as smalt business
concerns for purposes of paragraph (1)
(c) Action With Respect to C.iteqorils — (1) Any action author-
ized or required to be taken by the Administrator under any provision
of this Act with respect to a chemical substance or mixture may be
taken by the Administrator in accordance with that provision with
respect to a category of chemical substances or mixtures. Whenever
the Administrator takes action under a provision of this Act nitli
respect to a category of chemical substances or mixtures, any reference
in this Act to a chemical substance or mixture (insofar as it relates
to such action) shall be deemed to be a reference to each chemical
substance or mixture in such categoi v
(2) For purposes of paragraph (1)
(A) The term "category of chemical substances" means a group
of chemical substances the members of which are similar in molec-
ular structure, in physical, chemical, or biological properties, in
use, or in mode of entrance into the human body or into the
environment, or the members of which are in some other way suit-
able for classification as such for purposes of this Act, except tliat
such term does not mean a group of chemical substances v hicli ate
grouped together solely on the oasis of their being new cliemic&l
substances.
(B) The term "category of mixtures'' means a group of mix-
tures the members of which are similar in molecular structure, in
physical, chemical, or biological properties, in use, or in the mode
of entrance into the human body or into the environment, or the
members of which are in some other way suitable for classification
as such for purposes of this Act.
(d) Assistance Office.—The Administrator shall establish in tho
Environmental Protection Agency an identifiable office to provide
technical and other nonfinancial assistance to manufacturers and
processors of chemical substances and mixtures respecting the require-
ments of thiB Act applicable to such manufacturers and processors, the
policy of the Agency respecting the application of stiih requirements
to such manufacturers and processors, and the means and methods by
which Such manufacturers and processors mny comply with such
requirements.
(e) Financial Disclosures.—(1) Except as provided under pam
graph (3), each officer or employee of the Environmental Protection
Agency and the Department of Health. Education, and U'elfare who—
(A) performs any function or duty under this Act, and
(B) has any known financial interest (i) in any person subject
to this Act or any rule or order in effect under this Act, or (n) in
any person who applies for or receives any grant or contract under
this Act,
ahall, on February 1,1678, and on February 1 of each year thereafter,
file with the Administrator or the Secretary of Health, Education, and
Welfare (hereinafter in this subsection referred to as the "Secre-
tary"), as appropriate, a written statement concerning all such inter-
ests held by juch officer or employee during the preceding calendar
year. Such statement shall be made available to the public.
(2) The Administrator and the Secretary shall—
(A) act within 90 days of the effective date of this Act—
(l) to define the term "known financial interests" for pur-
poses of paragraph (1), and
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(ii) to establish the methods by which the requirement to
file written statements specified in paragraph (1) will be
monitored and enforced, including appropriate provisions for
renew by the Administrator and the Secretary of such state-
ments, and
(B) report to the Congress on June 1,1978, and on June 1 of
each year thereafter with respect to such statements and the
actions taken in regard thereto during the preceding calendar
year.
(3J The Administrator may by rule identify specific positions with
the Environmental Protection Agency, and the Secretaty may by rule
identify specific positions with the Department of Health, Education,
and Welfare, which are of a nonregulatory or nonpolicj making
nature, and the Administrator and the secretary may by rule provide
that officere or employees occupying such positions shall be exempt
from the requirements of paragraph (1).
(4) This subsection does not supersede any requirement of chapter
11 of title 18, United States Code.
(J) Any officer or employee who is subject to, and knowingly vio-
lates, this subsection or any rule issued thereunder, shall be fined not
more than $2,500 or imprisoned not more than one year, or both.
(f) Statehint or Basis avd Purpose.—Any final order issued
under this Act shall be accompanied bv a statement of its basis and
purpose. The contents and adequacy of any such statement shall not
be subject to judicial review in any respect.
(g) Assistant Admijjistbatoh.—(1) The President, by and with
the advice and consent of the Senate, shall appoint an Assistant
Administrator for Toxic Substances of the Environmental Protection
Agency. Such Assistant Administrator shall be a qualified individual
who is, by reason of background and experience, especially qualified
to direct a program concerning the effects of chemicals on human
health and the environment Such Assistant Administrator shall be
responsible for (A) the collection of data, (B) the preparation of
studies, (C) the making of recommendations to the Administrator for
regulatory and other actions to carry out the purposes and to facili-
tate the administration of this Act, and (D) such other functions as
the Administrator may assign or delegate.
(2) The Assistant Administrator to be appointed under paragraph
(1) shall (A) be in addition to the Assistant Administrators of the
Environmental Protection Agency authorized by section 1 (d) of Reor-
ganization Plan No. 3 of 1970, and (B) be compensated at the rate of
pay authorized for such Assistant Administrators.
SEC. V. DEVELOPMENT AND EVALUATION OF TEST METHODS.
(a) In Genera!.—The Secretary of Health, Education, and Welfare,
in consultation with the Administrator and acting through the Assist-
ant Secretarj for Health, inav conduct, and make grants to public and
nonprofit private entities and enter into contracts with public and
private entities for, projects for the development and evaluation of
inexpensive and efficient methods (1) for determining and evaluating
the health and environmental effects of chemical substances and mix-
tures, and their toxicity, persistence, and other characteristics which
affect lipo.lt]i and the environment, and (2) which may be used for the
development of test data to meet the requirements of rules promulgated
under section 4. The Administrator shall consider sucli methods in
prescribing under section 4 standards for the development of test data.
(b) Approval by Sechetabt—No grant may be made or contract
entered into under subsection (a) unless an application therefor has
been submitted to and approved by the Secretary Such an application
shall be submitted in such form and manner and contain such informa-
tion as the Secretary may require. The Secretary may apply such
conditions to giants and contracts under subsection (a) as the Secre-
tary determines are necessary to carry out the purposes of such subsec-
tion. Contracts may be entered into under such subsection without
regard to sections 3648 and 3709 of the Revised Statutes (31 U S.C-
529; 41 U.S.C. 5).
(c) A-Nncal Retorts.—(1) The Secretary shall prepare and sub-
mit to the President and the Congress on or oefore January 1 of each
year a report of the number of grants made and contracts entered into
under this section and the results of such grants and contracts
(2) The Secretary shall periodically publish in the Federal Register
reports describing the progress and results of any contract entered
into or grant made under this section.
SEC. 28. STATE PROGRAMS.
(a) In General.—For the purpose of complementing (but not reduc-
ing) the authority of, or actions taken by, the Administrator under
tins Act, the Administrator may make grants to States for the estab-
lishment and operation of programs to prevent or eliminate unreason-
able risks within the States to health or the environment which are asso-
ciated with a chemical substance or mixture and with respect to which
the Administrator is unable or is not likely to take action under this
Act for their prevention or elimination The amount of a grant under
tlus subsection shall be determined by the Administrator, except that
uo grant for any State program may exceed 73 per centum of the
establishment and operation costs (as determined by the Admin-
istrator) of such program during the period for which the grant is
made.
(b) AppBovAi.Br Aojiixistkatob.—(1) No grant may be made under
subsection (a) unless an application therefor is submitted to and
approved by the Administrator. Such an application shall be sub-
mitted m such form and manner as the Administrator may require and
shall—
(A) set foith the need of the applicant foT a grant undei subjec-
tion (a),
(H) identify the agency or agencies of the State which shall
establish or operate, or both, the program for which the applica-
tion is submitted,
(C) describe the actions proposed to be taken under sucli pro-
gnim,
(D) contain or be supported by assurances satisfactory to the
Administrator that such program shall, to the extent feasible,
be integrated with other programs of the applicant for environ-
mental and public health protection,
(E) provide for the making of such reports and evaluations
us the Administrator may require, and
(F) contain such other information as the Administrator may
prescribe
(2) The Administrator may approve an application submitted in
accordance with paragraph (1) only if the applicant has estnblished to
the satisfaction of the Administrator a priority need, as determined
under rules of the Administrator, for the grant for which the appli-
cation has been submitted Such rules shall take into consideration the
seriousness of the health effects in a State which are associated mth
chemical substances or mixtures, including cancer, birth defects, and
gene mutations, the extent of the exposure in a State of human beings
and the environment to chemical substances and mixtures, and the
extent to which chemical substances and mixtures are manufactured,
processed, used, and disposed of in a State.
(c) Anncal Reports—Not later than six months after the end of
each of the fiscal years 1979, 1980, and 1981, the Administrator shall
submit to the Congress a report respecting the programs assisted by
grants under bubsection (a) in the preceding fiscal year and the extent
to which the Administrator has disseminated information respecting
such programs.
(d) Authorization—For the purpose of making grants under
subsection (a) there are authorized to be appropriated $1,500,000 for
the fiscal year ending September 30,1977, $1,500,000 for the fiscal year
ending September 30, 1978, and SI,500,000 for the fiscal year ending
September 30, 1979 Sums appropriated under this subsection shad
remain available until expended.
SEC. ». AUTHORIZATION FOR APPROPRIATIONS.
There are authorized to be appropriated to the Administrator for
purposes of carrying out this Act (other than sections 27 and 28 and
subsections (a) and (c) through (g) of section 10 thereof) $10,100,000
for the fiscal year ending September SO, 1977, $12,625,000 for the fiscal
year ending September 30, 1978, $16,200,000 for the fiscal year ending
September 30, 1979 No part of the funds appropriated under this
section may be used to construct any research laboratories.
SEC. *X ANNUAL REPORT.
The Administrator shall prepare and submit to the President and
the Congress on or before January 1,1978, and on or before January 1
of each succeeding year a comprehensive report on the administration
of this Act during tne preceding fiscal year Such report shall include—
(I) a list of the testing required under section 4 during the year
for which the report is made and an estimate of the costs incurred
during such year by the persons required to perform such tests;
(2) the number of notices received dunne such year under
section 5, the number of such notices received during such year
under such section for chemical substances subject to a section 4
rule, and a summary of any action taken during such year under
section S(g),
(S) a list of rules issued during such year under sect ion 6,
(4) a list, with a brief statement of the issues, of completed or
pending judicial actions under this Act and administrative actions
under section 16 during such year;
(5) a summary of major problems encountered m the adminis-
tration of this Act, and
(6) such recommendations for additional legislation as the
Administrator deems necessary to carry out the purposes of this
Act
SEC II. EFFECTIVE DATE.
Except as provided in section 4(f). this Act shall take effect oil
January 1,1977
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Chapter Two
The
TSCA Inspector
Chapter Contents Page
1 TSCA Inspection Overview
Authority 2-1
Scope 2-2
Purpose 2-2
Confidentiality 2-3
Elements of an Inspection 2-4
Other Inspection Activities 3-5
2 Inspector Authority
Delegation 2-7
Credentials 2-7
Confidentiality Business information Access
Authorization 2-8
Waiver 2-9
Special Category 2-10
3 Inspector Responsibilities
Confidential Business Information Procedures 2-11
Professional Skills 2-12
Procedural Requirements 2-12
Communication and Interpersonal Skills 2-13
Work Ethics 2-14
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Chapter Two
1
Inspection
Overview
Inspections may be necessary for the enforcement of several of the pro-
visions of TSCA. Compliance inspection is the enforcement mechanism for
detection and verification of violations. Facilities are selected for
inspection under a neutral administrative inspection scheme or may be
selected "for cause." Selection may be made, depending on the circumstances,
by headquarters or regional offices.
Evidence obtained during an inspection may result in the Agency taking amy
of the following enforcement actions:
• Issue a notice on noncompliance;
• Issue a notice to show cause;
• Assess an administrative civil penalty;
• Institute a civil court action; or
• Institute a criminal court action.
The government's case in a formal hearing or criminal prosecution depends
on the accuracy and quality of the evidence gathered by the inspector.
Authority
Sections 11(a) and (b) provide the authority for conducting inspections to
monitor compliance with the provisions of, and rules under, TSCA. Any
establishment, facility, or other premises in which chemical substances
or mixtures are manufactured, processed, stored, or held before or after
distribution in commerce and any conveyance used to transport chemical
substances is subject to inspection under TSCA.
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Chapter Two
1 Inspection Overview
Scope
Inspections conducted under Section 11 extend to all things relating
to compliance with the requirements of TSCA which are within the
premises or conveyance being inspected. This includes:
• Records;
• Files;
• Rapers;
• Chemical substances;
• Processes
• Controls; and
• Facilities.
To carry out the inspection, samples may be taken and photographs may
be made.
Limitations
Certain types of data can only be inspected if the nature and extent of
such data are described specifically in the written Notice of Inspection
presented to the owner, operator, or agent in charge of the premises or
conveyance. These include:
• Financial data;
• Sales data (other than shipment data);
• Pricing data;
• Personnel data; or
• Research data (other than research data required by the
provisions of TSCA).
The purpose of inspection is to ensure compliance with TSCA and with the
rules under TSCA. The inspector's role is
• To inform the regulated industry of the requirements of
the law, and
• To document suspected violations.
Purpose
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Chapter Two
1 Inspection Overview
Confidentiality
During the course of TSCA inspections, inspectors will encounter
information which may be entitled to confidential treatment under
Section 14 of TSCA and EPA regulations (40 CFR Part 2). This Section
of the statute and the regulations are designed to protect confiden-
tial business information from ^authorized disclosure. Confidential
business information includes information considered to be trade secrets
(including chemical identity, process, formulation, or production data)
that could damage a company's competitive position if it became pub-
licly known.
Information collected during an inspection would be made available in
response to a Freedom of Information Act (FOIA) request unless the
information were determined to be exempt from release under strict
FOIA criteria. However, if the data has been claimed confidential
business information by the company, EPA would follow certain pro-
cedural steps prior to release of the information and the data would
not be released at all if it was determined to be entitled to con-
fidential treatment.
Because oE the sensitivity of some of the information that will be submitted
or collected under TSCft, very stringent procedures for handling confidential
information have been established for TSCA-Confidential Business Information
(TSCA-CBI). These procedures are contained in the TSCA-CBI Manual which
governs access to and control of documents by EPA personnel. There are
special procedures for access to TSCA-CBI by contractors and other Federal
agencies.
Because conducting TSCA inspections presents some special considerations
with regard to declaration and handling of confidential business information,
additional procedures concerning confidentiality have been incorporated
into each section of this manual. These procedures are designed to provide
adequate notification to companies of their right to declare inspection
data confidential and to ensure secure handling of this information at each
stage of the inspection.
NOTE: it should be clearly understood that the confidential business
information as referenced throughout this manual does not in
any manner refer to classified National Security Information
as defined in Executive Order 12065 nor do these procedures
imply authorization to classified information. All materials
claimed confidential Jbusiness information must be marked with
the words "Confidential business information does not include
National Security Information (EO 12065)."
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Chapter Two
1 Inspection Overview
Elements of an Inspection
The elements of TSCA facility inspections can be grouped into the following
five procedural categories: (1) pre-inspection preparation, (2) entry,
(3) opening conference, (4) sampling and documentation, and (5) the closing
conference. These elements are common to all inspections, but the emphasis
given to the separate elements will vary with the needs of the individual
inspection. Each of the procedural categories is discussed in detail in
Chapter Three of this manual. Refer to later Volumes for substance specific
details.
Pre-Inspection Preparation
To ensure effective use of the inspector's time, the following procedures
are undertaken before beginning the inspection of a selected facility:
• Establishing inspection objectives
• Establishing the scope of the inspection
• Conducting a review of Agency records
• Preparing necessary documents and equipment
Entry
Entry procedures are those which relate to obtaining actual physical entry
of the facility. Entry involves the following steps.
• Introduction
• Presenting credentials
• Presenting Notice of Inspection
• Managing denial of entry when necessary
Opening Conference
After entry, the inspector conducts an opening conference with the facility
management. During the opening conference, the inspector is responsible
for the following activities:
• Discussing the objectives and scope of the inspection
• Presenting the TSCA Inspection Confidentiality Notice
• Advising of the availability of duplicate samples
• Providing information on TSCA and its rules
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Sampling and Documentation
Reviewing facility records, taking physical samples, and preparing
documentation are the basic inspection activities. It is these activities
which provide the evidentiary support the Agency uses in enforcement
actions. The inspector's responsibilities include:
• Targeting and locating facility records
• Assessing facility records
• Preparing documentation of all inspection activities
• Assessing conditions and taking necessary samples
• Operating in a safe and efficient manner
Closing Conference
The closing conference with facility officials enables the inspector to
prepare receipts, answer questions, and provide information about TSCA.
At the closing conference, the inspector "wraps up" the inspection by
• Writing necessary receipts
• Reviewing confidentiality claims
« Discussing inspectional findings
Other Inspection Activities
Inspectors may be called upon to participate in special inspectional
operations. Such inspections are conducted under TSCA authority and
usually contain the same elements as scheduled TSCA inspections.
Inspections may be undertaken as a result of the need for emergency
response, or as a result of citizen, labor, or industry complaints.
Emergencies
The nature of the substances regulated under TSCA may involve
inspectors in responding to potentially dangerous emergency situa-
tions. Inspectors may be called upon to undertake inspections in
cases of possible imminent hazard or other unforeseeable circum-
stances that are violations of TSCA. The usual requirements and
procedures for inspection apply in such cases. Although it may
not be possible to plan or conduct pre-inspection procedures with
customary thoroughness, the elements of the inspection remain
essentially the same. The importance of safety procedures and
precautions should be stressed in such situations.
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Complaints and Citizen Referrals
EPA inspectors may conduct inspections which are being undertaken as a
result of complaints or other information submitted to the Agency by
workers, industry, individual citizens, or citizen groups. For the
goals of TSCA to be achieved, this kind of public participation in the
detection of discrepancies and potential violations is of great value and
should be encouraged by inspectors. Referrals and tips given to an inspector
should be thoroughly investigated, and whenever possible, substantiating
evidence should be obtained to aid in followup inspections.
Section 23 of TSCA protects from discrimination any employee who
reports a violation to EPA or who testifies or otherwise participates
in a proceeding against a firm.
Referral Inspection Program
The IRLG referral inspection program was created so that inspectors from
the member agencies — Consumer Product Safety Commission (CPSC), Food
and Drug Administration (FDA), Occupational Safety and Health Administration
(OSHA), Food Safety and Quality Service (FSQS), and EPA — could recognize
and make referrals of potential violations of another agency's laws or
regulations. Inspectors from the member agencies are trained to
recognize and refer such potential violations to the appropriate agency
for followup inspection. EPA inspectors may be called upon to make such
referrals or to handle followup investigations and inspections resulting
from another agency's activities. {For details and guidance on IRLG
programs consult with your supervisor.)
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Chapter Two
2
Inspector
Authority
Inspectors are skilled professionals who represent the Agency in dealing
with regulated industry and the public. Inspectors cure responsible for
conducting inspections in a professional manner that reflects credit on
themselves and the Agency. The primary responsibility of inspectors is
to inspect facilities for compliance with TSCA requirements.
Inspector Authority
Delegation
Authority to inspect under TSCA is granted to the EPA Administrator
who, in turn, has redelegated his authority to the Regional Adminis-
trators and Headquarters enforcement personnel.
The individual inspector is granted the authority to inspect under TSCA
through the issuance of a multi-media inspection credential which identifies
the inspector as a duly designated representative of the Administrator.
An inspector is, then, a specially appointed representative of the
Administrator, charged with enforcement of TSCA.
Credentials
Official EPA inspection credentials are issued to each inspector and
empower the inspector to conduct Agency inspections.
Only persons with multi-media inspection credentials have the right to
conduct facility inspections. The Act requires that these credentials
be presented to appropriate facility personnel at each inspection.
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Chapter Two
2 Inspector Authority
Credentials are valuable documents which should never leave the sight
of the inspector; they must never be permitted to be photocopied.
Applicable Laws. To carry out their duties effectively, inspectors must
be thoroughly familiar with the legal basis for their actions. An inspector
must be thoroughly knowledgeable about:
• Toxic Substances Control Act
• Regulations promulgated under TSCA
In addition, an inspector should be familiar with other EPA-administered
laws relating to toxics, including
• Federal Water Pollution Control Act
• Clean Air Act
• Federal Insecticide, Fungicide, and Rodenticide Act
• Resource Conservation and Recovery Act
• Safe Drinking Water Act
Confidential Business Information Access Authorization
An inspector who conducts TSCA inspections is likely to encounter TSCA
Confidential Business Information {TSCA-CBI). Since such information
may only be viewed by individuals who have been cleared for access,
each TSCA inspector will be required to have a TSCA-CBI access
autho ri z at ion.
Following is a brief summary of the specific procedures that have been
developed for obtaining access authorization to TSCA-CBI. Check with
the Document Control Officer for complete instructions and necessary
forms.
The form "Authorization for Access to TSCA Confidential Business
Information" outlines the three basic steps of the authorization
process:
1. The inspector must obtain written authorization from the
Division Director or other appropriate authorizing official.
(Part I of the form.)
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Chapter Two
2 Inspector Authority
2. The inspector must sign the Confidentiality Agreement for
EPA Employees. (Part II of the form.)
3. The local Document Control Officer must certify that
appropriate investigative forms have been filed with the
Headquarters Security Branch. (Part III of the form.)
Upon completion of this process, the local Document Control Officer
will place the inspector's name on the Authorized Access List and will
notify the inspector of the authorization.
A letter certifying that the inspector is authorized for access will be
issued by the Deputy Administrator for General Enforcement. This
letter may be used to prove authorization upon entry into a facility.
Special Category
i
Seme TSCA Confidential Business Information, considered particularly
sensitive, has been designated Special Category TSCA-CBI. This sub-
set includes: (1) specific chemical identities, (2) information about
product formulations, and (3) information about specific processes
used in manufacturing or processing.
Inspectors who perform TSCA inspections under Sections 5 and 8 or
certain kinds of inspections under Section 6 rules should request
Special Category clearance. An inspector who has Special Category
also has general access. See the Document Control Officer for details.
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Chapter Two
3
Inspector
Responsibilities
A high level of professional skills and work ethics standards is re-
quired of all inspectors. Inspectors are required to have a working
knowledge of all applicable laws and regulations, to be familiar with
Agency legal and procedural requirements, and to develop appropriate
communications and interpersonal skills. In the execution of their
duties inspectors are expected to collect samples, review records,
and prepare the appropriate documents associated with the inspection.
Confidential Business Information Procedures
The Agency recognizes the obligation of trust placed upon it by the
reporters of confidential business information. For this reason,
EPA employees are prohibited under penalty of law from disclosing, in
any manner and to any extent not authorized by law, any TSCA Confi-
dential Business Information (TSCA-CBI) coming to them in the course
of their employment or official duties. Unauthorized disclosure of
such information may subject the employee to criminal penalties of up
to $5,000 and/or imprisonment for up to one year.
Inspectors will be required to abide by the terms of the "Confidentiality
Agreement for EPA Employees" they have signed. In addition, inspectors
must be familiar with and carefully follow the procedures for handling
TSCA-CBI as prescribed in the TSCA-CBI Security Manual as well as the
additional confidentiality procedures discussed throughout this manual.
When practical circumstances in the field prohibit strict adherence to
these procedures, inspectors are expected to take all measures necessary
to ensure protection of the information.
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Chapter Two
3
Inspector Responsibilities
Professional Skills
Procedural Requirements
Effective inspections are based upon experience, and upon knowledge and
observance of correct procedures. Inspectors are required to be familiar
with legal requirements, procedures for effective evidence gathering, and
safety practices.
• Legal Requirements
Because the inspector directly represents the Agency to regulated
industry, it is essential that he carefully abide by the legal
and regulatory requirements of the Act.
Inspection Requirements. Inspectors must be familiar with and
observe specific legal requirements that have been established
for inspection, including:
• Presentation of proper credentials
• Presentation of required notices and receipts
• Proper handling of confidential business information
Regulatory Requirements. Inspectors must be familiar with and
observe all of the regulations regarding the handling of chemical
substances controlled under TSCA.
• Evidence Gathering
Inspectors must be familiar with general evidence gathering
techniques, including collecting samples and obtaining
statements from witnesses.
The specific information collected during a TSCA inspection will
depend on the nature of the regulatory requirement being monitored.
The objective of inspections is to document suspected violations
of the law. Because the Government's case in a civil or criminal
prosecution depends on the evidence gathered by the inspector,
it is imperative that each inspector keep detailed records of each
inspection and describe all photographs taken during an inspection.
This data will serve as an aid in preparing the inspection report,
in determining the appropriate enforcement response, and in giving
testimony in an enforcement case.
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Chapter Two
3 Inspector Responsibilities
• Safety
The handling and sampling of any chemical substance regulated under
TSCA always poses a certain degree of risk. To avoid unnecessary
health and safety risks it is the responsibility of each inspector
• To be thoroughly familiar with all safety guidance and
practices for TSCA substances;
• To use safety equipment in accordance with guidance received and
labeling instructions;
• To maintain safety equipment in good condition and proper
working order;
• To dress appropriately for the activity in which he is
engaged, and wear appropriate protective clothing; and
• To wear any safety equipment customary in the establishment
being inspected, e.g., hard hat or safety glasses.
NOTE: See Chapter Three, Section 4f for detailed information on Health
and Safety.
Communications and Interpersonal Skills
TSCA inspectors must know how to effectively apply and communicate
information relating to inspection operations. Inspectors should develop
and maintain expertise in relevant communications and interpersonal areas.
Inspectors should know:
• How to substantiate all facts with statements of witnesses
or items of evidence.
• How to evaluate what evidence is necessary to obtain
successful civil actions, criminal prosecution, or seizure.
• How to obtain respect, inspire confidence, and maintain the
good will of the public, industry, and consumers.
• How to detect discrepancies or lack of good faith during
interviews.
• How to testify in court and administrative hearings.
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Chapter Two
3 Inspector Responsibilities
• How to conduct sampling procedures in a professional and
safe manner.
• How to write clear and informative reports.
Work Ethics
As officers of the Federal government, inspectors are expected to perform
their duties as responsible law enforcement officers with the highest degree
of honesty. Procedures and requirements ensuring ethical actions have been
worked out through many years of EPA and Federal government inspectional
experience. These procedures and standards of conduct have evolved for
the protection of the individual and the Agency, as well as industry, so
that the rights of neither are jeopardized. The inspector has an
opportunity to set an example for private industry in encouraging concern
over health and safety in the environment and to reinforce attitudes
encouraging compliance with laws that protect the environment.
• All investigations are to be conducted within the framework
of the United States Constitution and with due regard for
individual rights regardless of race, sex, creed, or national
origin.
• Inspectors are to conduct themselves at all times in accordance
with the regulations prescribing EPA ESnployee Responsibilities
and Conduct, which are codified at 40 CFR Part 3 and available
in the EPA handbook "Responsibilities and Conduct for EPA
Employees."
• The facts of an investigation are to be developed and reported
completely, accurately, and objectively.
• In the course of an investigation, any act or failure to act
motivated by- reason of private gain is illegal. Actions which
could be construed as such should be scrupulously avoided.
• A continuing effort to improve professional knowledge and
technical skill in the investigative field should be made.
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Chapter Two
Inspector Responsibilities
Professional Attitude. The inspector is a representative of EPA and
is often the initial or only contact between the Agency and the
regulated industries. In dealing with industry representatives and
employees, inspectors must be dignified, tactful, courteous, and
diplomatic. A firm but responsive attitude will help establish an
atmosphere of cooperation and will initiate good working relations.
Attire. Inspectors should dress appropriately, including wearing
protective clothing or equipment, for the activity in which they are
engaged.
Industry, Public, and Consumer Relations. All information acquired in
the course of an inspector's duties is for official use only. Inspectors
should not speak of any product, manufacturer, or person in a derogatory
manner.
Gifts, Favors, Luncheons. Inspectors should avoid accepting favors
or benefits under circumstances that might be construed as influencing
the performance of government duties. EPA regulations provide an
exemption whereby an inspector could accept food and refreshments of
nominal value on infrequent occasions in the ordinary course of a
luncheon or dinner meeting or other meeting, or during an inspection
tour. Inspectors should use this exemption only when absolutely
necessary.
Requests for Information. EPA has an "open-door" policy on releasing
information to the public. This policy aims at making information
about EPA and its work freely and equally available to all interested
individuals, groups, and organizations. In fact, EPA employees have
both a legal and traditional responsibility for making useful educational
and safety information available to the public. This policy, however,
does not extend to information relating to the suspicion of a violation,
evidence of possible misconduct, or ccnfidential business information.
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Chapter Three
Inspection
Procedures
Chapter Contents Page
1 Pre-Inspection Preparation
Agency Records Review 3-1
Review Considerations 3-1
Confidential Business Information 3-2
Safeguards During Use 3-3
Document Preparation 3-3
Inspection Documents 3-3
Equipment Preparation 3-4
Form and Equipment Checklist 3-5
2 Entry
Authority 3-7
Arrival 3-7
Credentials 3-8
Notice of Inspection 3-8
Consent 3-8
Reluctance to Give Consent 3-9
Uncredentialed Persons Accompanying an Inspector 3-9
Denial of Entry 3-9
Denial of Entry Procedures 3-9
Withdrawl of Consent During Inspection 3-10
Denial of Entry to Some Areas of the Facility 3-10
Administrative Warrants 3-11
Policy 3-11
Securing and Serving a Warrant 3-12
3 Opening Conference
The Inspector as Educator 3-15
Meeting Considerations 3-15
Confidentiality Notice and Discussions 3-16
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Chapter Three
Contents
3 Opening Conference (continued)
Authority to Make Confidential Claims 3-17
Confidentiality Discussion 3-17
Preparation/Distribution of Confidentiality Forms 3-18
Other Considerations 3-19
Duplicate Samples 3-19
Photographs 3-19
4 Sampling and Documentation
a Introduction
Authority 3-21
Objectives 3-21
b Records Inspection
Objectives 3-23
Types of Records 3-24
Procedures and Considerations 3-24
Targeting and Locating Records 3-25
Copying Records 3-26
Written and Printed Records 3-26
Computer and Electronic Records 3-26
Visual Systems 3-27
Identification Procedures 3-27
Initialing and Dating 3-27
Numbering 3-27
Logging 3-27
General Considerations 3-28
Confidentiality Considerations and Procedures 3-28
Preliminary Indications of Confidentiality 3-28
Manual Copying of Records 3-29
Photocopying Documents 3-29
Identification of Confidential Documents 3-29
c Documentary Support
Objective 3-31
Inspector's Field Notebook 3-31
Confidentiality Considerations and Procedures 3-32
Inspection Entries 3-33
Administrative Entries 3-33
Statements 3-33
Photographs 3-35
Confidentiality Considerations 3-36
Drawings and Maps 3-36
Printed Matter 3-36
Mechanical Recordings 3-36
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Chapter Three
Contents
d Physical Samples
Definitions 3-37
Sampling Program 3-38
Definite Purpose 3-38
Representative Sample 3-38
Proper Equipment 3-38
Sufficient Sample Volume 3-39
Controlled Identification 3-39
Initiating Chain of Custody Record 3-40
Proper Handling 3-41
Adequate Documentation 3-42
e Chain of Custody
Elements of Custody 3-43
Procedures 3-44
Establishing Custody 3-44
Preparing Sample Documentation 3-44
Coordinating Sample and Documentation 3-44
Ensuring Custody During Transit 3-44
Confidential Samples 3-45
f Health and Safety
Inspector Responsibilities 3-47
Personal Protective Equipment 3-47
General Safety Equipment 3-49
Handling of Chemical Substances 3-49
Emergency Treatment 3-50
Inhalation 3-51
Skin Exposure 3-52
Eye Contact 3-53
Ingestion 3-54
Decontamination of Protective Clothing 3-55
Long Term Risk 3-55
Emergency Telephone Numbers 3-56
Respiratory Protective Equipment 3-57
Bibliography 3-58
5 Closing Conference
Required Receipts 3-61
Receipt for Samples and Documents 3-61
Declaration of Confidential Business Information 3-62
Industry Outreach 3-63
6 Security Measures
Overview 3-65
Routine Security Measures 3-65
TSCA-CBI Security Procedures 3-66
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Chapter Three
1
Pre-lnspection
Preparation
Preplanning is necessary to ensure that the inspection is properly focused,
and that the inspection is conducted both smoothly and efficiently.
During the preplanning process, documents, forms, equipment, and educational
material necessary to the inspection should be prepared.
Agency Records Review
A thorough review of records in Agency files relating to a facility to be
inspected is essential in pre-inspection preparation. This review will
save time and minimize inconvenience during an inspection by not requiring
examination of information that has previously been made available. The
review will also give the inspector important background information on
the facility's operations and compliance history.
Review Considerations
The following documents and types of information may be reviewed in
preparing for an inspection:
• General facility information, including type, size, and
location of the facility to be inspected. This information
will be helpful in planning time and resource allocation and
in preparing documents and equipment.
• Previous inspection records and reports on enforcement proceedings
that resulted from other inspections. Special note should be
made of any violations observed in previous inspections so the
facility can be checked to ensure current compliance.
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• Special exemptions from requirements that may have been
granted by EPA. Additional requirements may have been placed
on the facility in granting the exemption.
• Reports prepared by the facility that were obtained during
previous inspections. Inspectors should review these reports
and note any discrepancies previously observed in the facility
records. If information is not clearly presented in the annual
facility report, an inspector should note that deficiency in
order to pay particular attention during the inspection and
thus clarify the information.
• Documents, correspondence, and permits concerning current
wastewater discharge, solid waste disposal, and on-going con-
struction.
• Additional information may be requested from the facility when
obvious inadequacies, inconsistencies, or voids are discovered
in the facility files.
Confidential Business Information
An inspector may need access to confidential business information in
the course of preparing for an inspection. This information may
consist of confidential business data a firm has previously reported
to the Agency or which was collected during a prior inspection. The
inspector will request access to-the information from the appropriate
Document Control Officer (DCO), who will:
• Verify the inspector's listing on the authorized access list.
• Secure a copy for the inspector.
• Determine if the inspector has secure storage approved by the
Security Branch. Confidential business data may be checked
out for 30 days if storage provisions are adequate according
to Chapter III 3.b. of the TSCA-CBI Security Manual. Otherwise,
data must be returned to the DCO that same day.
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Safeguards During Use
Confidential business information, when in actual use by an authorized
person, is to be protected in the following manner:
• Kept under the constant surveillance of an authorized
person who can exercise direct security control over
the material.
• Covered, turned face down, placed in approved storage con-
tainers, cr otherwise protected, when unauthorized persons
are present.
• Returned to approved storage containers when not in use or
to the DCO at close of business when not.checked out.
• Discussed only with other authorized persons. (Check with
the DOQ to detant.ine if the person is authorized.)
« Transferred to one authorised person vithin a division, by
means of a Loan Receipt for TSCA-CBI available from the
DCO. A copy of the Beceipt is to be furnished to the
DCO. The secondary recipient must also sign the cover
sheet.
Document Preparation
Documents and forms necessary for the inspection should be prepared in
advance of the inspection whenever possible. (Document and form samples
and instructions for completion can be found in Chapter Six. Discussions
of their use appear at the appropriate places in the text.)
Inspection Documents
• Notice of Inspection. Written notice must be presented upon
the inspector's arrival at the facility. Portions of this
form can be filled out in advance; but the time of inspection
and name(s) of facility official(s) are entered at the time
of inspection.
• Compliance Report Form. Substance-specific inspection Volumes
will provide a detailed oompliance form which will guide in-
spectors in gathering relevant information.
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Chapter Three
1 Pre-lnspection Preparation
• TSCA Inspection Confidentiality Notice. This form is used to
inform facility officials of their right to claim inspection
data confidential business information.
• Sampling Documents. The following forms relate to physical
samples and are used to record and control sample identification
and custody. These forms are discussed in detail in Chapter
Three, Sections 4d and 4e, and include:
• Custody Seal(s)
• Chain of Custody Record
• Receipt of Samples and Documents. All samples and documents
taken during an inspection are listed on this form.
• Declaration of Confidential Business Information. This form
is used to list all documents and samples taken during an
inspection that have been claimed confidential business
information.
• Copies of TSCA and of Specific Regulations. Some facility
officials may not have copies of the Act or of applicable rules
and regulations. Inspectors should have these available for
distribution.
• Agency Outreach Materials. Inspectors should provide current,
relevant educational information to facility officials relating
to voluntary compliance efforts.
Equipment Preparation
The kinds of equipment that an inspector carries should be specifically
related to the kind of inspection to be undertaken. For example, a PCB
inspection will require several kinds of sampling devices and containers,
while a CFC inspection may only require packaging materials for samples.
The inspector is expected to use sound judgment and rely on training
and past experience in deciding what equipment is necessary for a particular
inspection.
Checklists are provided as guidelines for inspectors. The requirements of
the inspection, the availability of certain equipment, and regional
policies and conditions are, of course, to be considered during this
pre-inspection phase.
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Form and Equipment Checklist
• All equipment should be well-maintained and checked to see
that it is in good condition prior to each inspection.
• Special circumstances may require equipment such as fireproof
clothing or self-contained breathing units. Check with your
supervisor for guidance and availability if the situation
may warrant such extra safety measures.
General Equipment
• Camera
• Film and flash equipment
• Pocket calculator
• Tape measure
• Clipboard
• Waterproof pens, pencils, markers
• Locking brief case
• "Confidential Business Information" stamp
• Stamp pad
• Envelopes pre-addressed to Document Control Officer
• Plain envelopes
• Polyethylene bags
• Disposable towels or rags
• Portable typewriter
• Portable copying machine
• Flashlight and batteries
• Pocket knife
Sampling Equipment
The use of quality disposable equipment can be very helpful in
eliminating or minimizing sample contamination. If the use of
disposable equipment is not feasible or not possible, sampling
equipment should be thoroughly decontaminated by a qualified
Laboratory -
• Crescent wrench, bung opener
• Siphoning equipment
• Weighted bottle sampler
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Chapter Three
1 Pro-Inspection Preparation
• Bottom sediment sampler
• Liquid waste samplers (e.g., glass samplers)
• Auger, trowel, or core sampler
• Scoop sampler
• Sample bottles and containers (certified clean bottles with
teflon-lined lids)
• Labeling tags, tape
• Storage and shipping containers with lids
• Ice chest
• Container for contaminated material
Safety Equipment (See Chapter Three, Section 4F for details)
• Safety glasses or goggles
• Face shield
• Ear plugs
• Rubber-soled, metal-toed, non-skid shoes
• Liquid-proof gloves, disposable if possible
• Coveralls, long sleeved
• Long rubber apron
• Hard hat
• Plastic shoe covers, disposable
• Respirators and cartridges
• Self-contained breathing apparatus
Emergency Equipment (See Chapter Three, Section 4F for details)
• Substance-specific first aid information
• Emergency telephone numbers
• First-aid kit with eyewash
• Fire extinguisher
• Soap, waterless hand cleaner, and towels
• Supply of clean water for washing
Forms
• Notice of Inspection
• TSCA Inspection Confidentiality Notice
• Declaration of Confidential Business Information
• Receipt for Samples and Documents
• Chain of Custody Record
• Official Seal
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Chapter Three
2
Entry
Authority
Section 11 of TSCA provides authority for an Effi inspector to enter
'kny establishment or facility in which chemical substances are
manufactured, processed, stored, or held before or after their distri-
bution in commerce. "
Under Section 11, the inspector is required to present the owner, operator,
or agent in charge of the facility with:
• Eroper credentials identifying the holder as a duly
authorized representative of the ER Administrator; and
• A written notice of inspection.
In addition, Section 11 requires inspections to be:
• Commenced and completed with reasonable promptness;
• Conducted at reasonable times;
• Conducted within reasonable limits; and
• Conducted in a reasonable manner.
Arrival
Arrival at the facility must be during normal working hours. The facility
owner or agent in charge should be located as soon as the inspector
arrives on the premises.
Locating the proper officials may take some time and require contact
with several receptionists and secretaries. Inspectors should be
careful to keep official credentials in sight at all times during
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the process. Business cards (available at inspector cost through
the Regional Offices) may be used for introductory purposes but do
not replace official credentials for identification.
Credentials
When the proper facility officials have been located, the inspector
should introduce himself as an Effi inspector and present the proper
Effi credentials as required in Section 11. These credentials indicate
that the holder is a lawful representative of the Administrator of EPA
and is authorized to perform inspections under TSCA regulations. The
credentials must be presented whether or not identification is
requested.
After facility officials have scrutinized the credentials, they may
telephone the EBv regional office for verification of the inspector's
identification.
Credentials should never leave the sight of the inspector.
Notice of Inspection
Once inspector identification has been established, the written Notice
of Inspection is to be presented to the facility officials as required
by Section 11. The notice should be dated, and the time of inspection
should be entered as proof that entry was requested at a reasonable
hour.
If records ordinarily exempt from inspection (financial, sales, pricing,
personnel, or research data) are specifically listed on the Notice,
facility officials should be informed verbally of the intent to inspect
these records.
(See Sample Notice of inspection in Chapter 6: Forms)
Consent
Consent to inspect the premises must be given by the owner or by the
agent-in-charge at the time of the inspection. As long as the in-
spector is allowed to enter, entry is considered voluntary and con-
sensual, unless the inspector is expressly told to leave the premises.
Express consent is not necessary; absence of an express denial con-
stitutes consent.
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Reluctance to Give Consent
The receptiveness of facility officials toward inspectors is likely
to vary from firm to firm. Most inspections will proceed without
difficulty, if consent to enter is flatly denied, the inspector
should follow Denial of Qitry procedures. In other cases, officials
may be reluctant to give entry consent because of misunderstandings of
responsibilities, inconvenience to a firm's schedule, or other reasons
that may be overcome by diplomacy and discussion.
Whenever there is difficulty in gaining consent to enter, inspectors
should tactfully probe the reasons and work with officials to over-
come the obstacles. Care should be taken, however, to avoid threats
of any kind, inflammatory discussions, or deepening of misunderstand-
ings. If the situation is beyond the authority or ability of the
inspector, the Regional Office should be contacted for guidance.
Uncredentialed fersons Accompanying an Inspector
The consent of the owner or agent in charge must be obtained for the
entry of persons accompanying an inspector to a site if they do not
have specific authorization. If consent is not given voluntarily,
these persons may not enter the premises. If consent is given, these
persons may not view confidential business information unless officially
authorized for access.
Denial of Ehtry
If an inspector is refused entry into a facility for the purpose of an
inspection under TSCA, certain procedural steps must be followed.
The procedures have been developed in accordance with the 1978 U.S.
Supreme Court decision in Marshal v. Barlow's, Inc.
Denial of Bitry Brocedures
1. Make certain that all credentials and notices have been
properly presented to the facility owner or agent in charge.
2. If^entry is not granted, ask why. Tactfully probe the reason
for the denial to see if obstacles (such as misunderstandings)
can be cleared. If resolution is beyond the authority of the
inspector, he may suggest that the officials seek advice from
their attorneys on clarification of the scope of Em's in-
spectional authority under Section 11 of TSCA.
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3. If entry is still denied, the inspector should withdraw
from the premises and contact his supervisor. The
supervisor will confer with attorneys to discuss the
desirability of obtaining an administrative warrant, and
will contact the Headquarters Pesticides and Toxic
Substances Enforcement Division.
4. All observations pertaining to the denial are to be care-
fully noted in the field notebook. Include facility name
and exact address, name and title of person (s) approached,
authority of person who refused entry, time of denial,
reason for denial, facility appearance, any reasonable
suspicions that refusal was based on a desire to cover up
regulatory violations, etc. All such information will be
important should a warrant be sought.
Important Considerations
• Under no circumstances should the inspector discuss
potential penalties under Section 15 of TSCA or do
anything that may be construed as coercive or threatening.
• Inspectors should avoid any situations that may be
potentially threatening or inflammatory.
• Inspectors should leave a copy of the written Notice of
Inspection with facility officials to show that proper
procedures were followed.
Withdrawal of Consent During Inspection
If the agent in charge asks the inspector to leave the premises after
the inspection has begun, the inspector should follow the procedures
above for denial of entry. All activities and evidence obtained prior
to the withdrawal of consent are valid.
Denial of Access to Some Areas of the Facility
If, during the course of the inspection, access to some parts of the
facility is denied, the inspector should make a notation of^the circum-
stances surrounding the denial of access and of the portion of the in-
spection that could not be completed. He should proceed with the rest
of the inspection. After leaving the facility, the inspector should
contact the regional office to determine whether a warrant should be
obtained to complete the inspection.
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2
Entry
Administrative
Warrants
An administrative warrant can be used to gain entry into a facility when
facility officials have denied entry to an inspector or when consent to
inspect has been withdrawn during an inspection. A warrant is a judicial
authorization for an appropriate official (EPA inspector, U.S. Marshal, or
other Federal officer) to enter a specifically described location and per-
forin specifically described inspection functions.
Policy
Denied Entry
It is the policy of EPA to obtain a warrant when all other efforts to
gain lawful entry have been exhausted, and the inspector has carefully
followed established entry/denial of entry procedures. Determination
to secure a warrant will be made by the Regional Office in consultation
with the Headquarters Pesticides and Toxic Substances Enforcement Division.
In Advance of Inspection
A warrant may be obtained before the inspector sets forth to conduct the
inspection. A pre-inspection warrant may be obtained at the discretion
of the Regional Office in consultation with the Headquarters Pesticides
and Toxic Substances Enforcement Division if:
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Chapter Three
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• A violation is suspected which could be covered up during
the time needed to secure a warrant;
• Prior correspondence or other contact with the facility to
be inspected provides reason to believe that entry will be
denied when the inspector arrives; or
• The facility is unusually remote from the Regional Office or
a U.S. District court and obtaining a warrant would be in-
convenient to the government.
Securing and Serving a Warrant
The procedures for obtaining and serving a warrant involve a number of
people, and are as follows:
1. Contact the Regional Office. The inspector should discuss
the facts regarding the denial or withdrawal of consent or
the circumstances which give rise to the need for a pre-
inspection warrant. The determination will then be made
whether or not to seek a warrant, and who should contact the
U.S. Attorney.
2. Contact the Headquarters Pesticides and Toxic Substances
Enforcement Division. The Regional Office will consult
with Headquarters in accordance with established policy.
3. Contact the U.S. Attorney. After a decision has been made
to obtain the warrant, the designated regional official
should contact the U.S. Attorney of the district in'which
the property is located. The Agency should assist the
Attorney in the preparation of the warrant and necessary
affidavits.
4. Apply for the Warrant. The application for a warrant should
identify the statutes and regulations under the Agency is
seeking the warrant. The name and location of the site or
establishment to be inspected should be clearly identified,
and, if possible, the owner and/or operator should be named.
The application can be a one- or two-page document if all
factual background for seeking the warrant is stated in the
affidavit, and the application so states. The application
is to be signed by the U.S. Attorney or by his assistant.
(See the model warrant in the Appendix.)
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5. Prepare the Affidavits. The affidavits in support of the
warrant application are crucial documents. Each affidavit
should consist of consecutively numbered paragraphs that
describe all of the facts in support of warrant issuance.
Each affidavit should be signed by a person with first-hand
knowledge of all the facts stated, most likely the inspector.
An affidavit is a sworn statement that must be notarized or
sworn to before the magistrate. (See the model affidavit in
the Appendix.)
6. Prepare the Warrant for Signature. The draft warrant should
be ready for the magistrate's signature. Once signed, the
warrant is an enforceable document. The warrant should
contain a "return of service" or "certificate of service"
which will indicate upon whom the warrant was served.
This part of the warrant is to be dated and signed by the
inspector after the warrant is served. (See the model
warrant in the Appendix.)
7. Serve the Warrant. The warrant is served on the facility
owner or his agent in charge and the inspection will normally
commence or continue. Where there is probability that
entry will still be refused, or where there are threats of
violence, the inspector should be accompanied by a U.S.
Marshal. In this case, the Marshal is principally charged
with executing the warrant, and the inspector should abide
by the Marshal's decisions.
8. Inspecting with the Warrant. The inspection should be
conducted strictly in accordance with the warrant. If
sampling is authorized, all procedures must be followed
carefully, including presentation of receipts for all
samples taken. If records or other property are authorized
to be taken, the inspector must issue a receipt for the
property and maintain an inventory of anything removed from
the premises. This inventory will be examined by the
magistrate to assure that the warrant's authority has not
been exceeded.
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9. Return the Warrant. After the inspection has been completed, the
warrant must be returned to the magistrate. Whoever executes
the warrant (i.e., the U.S. Marshal or whoever performs the
inspection), must sign the return of service form indicating to
whom the warrant was served and the date of service. The
executed warrant is then returned to the U.S. Attorney who will
formally return it to the issuing magistrate or judge. If
anything has been physically taken from the premises, such as
records or samples, an inventory of such items must be submitted
to the court, and the inspector must be present to certify that
the inventory is accurate and complete.
10. Important Considerations
• The application for a warrant should be made as soon as
possible after the denial of entry or withdrawl of consent.
• The warrant must be served without undue delay and within
the number of days stated (standard is 10 days). The warrant
will usually direct that it be served during daylight hours.
• Since the inspection is limited by the terms of the warrant,
it is very important to specify to the greatest extent
possible the areas intended for inspection, records to be
inspected, samples to be taken, etc. A vague, overly broad
warrant, however, will probably not be signed by the magistrate.
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Chapter Three
3
Opening
Conference
Once credentials and required notices have been presented the inspector
can proceed to outline inspection plans with facility officials.
The Inspector as Educator
The opening conference provides an ideal opportunity for the inspector to
strengthen Agency-Industry relations. The inspector's role of educator
and public relations liaison is important in establishing a sound spirit
of cooperation. The inspector is regarded as a source of regulatory
information, and should provide tactful help before, during, and after
the inspection. Areas of particular concern include:
• Voluntary compliance
• Overview of the law
• Specific regulation requirements
• Help with specific problems
• Agency outreach efforts
• Other resources for Agency assistance
Meeting Considerations
• Inspection Objectives. An outline of inspection objectives
will inform facility officials of the purpose and scope of
the inspection and may help avoid misunderstandings.
• Order of Inspection. A discussion of the order in which
operations will be inspected will help eliminate wasted
time by allowing officials time to make records available
and start up intermittent operations.
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• Meeting Schedules. A schedule of meetings with key personnel
will allow them to clear time to meet with the inspector.
• Organizational Directory. A telephone directory or a chart
showing how the facility is organized would be helpful.
• List of Records. A list of records to be inspected will allow
officials to gather and make them available for the inspector.
• Accompaniment. It would be beneficial to encourage a facility
official to accompany the inspector during the inspection to
describe the plant and its principal operating characteristics
and to indicate which processes, records, etc., should be
claimed as confidential business information. (See below.)
• Safety Requirements. The inspector should determine what OSHA
and facility safety regulations will be involved in the
inspection, and should be prepared to meet these requirements.
• Closing Conference. A "wrap-up" meeting should be scheduled
with appropriate officials to provide a final opportunity to
gather information, answer questions, and complete administra-
tive duties.
• New Requirements. The inspector should discuss any new rules
and regulations which might affect the facility, and answer
questions pertaining to them. If the inspector is aware of
proposed rules which might affect the facility, he may wish
to encourage facility officials to obtain a copy.
• General Information. Any necessary general information such
as the name and address of the chief executive officer should
be obtained during the meeting.
Confidentiality Notice find Discussions
The TSCA Inspection Confidentiality Notice (see Chapter Six: Forms) is
presented to the facility owner or agent in charge during the opening
conference. This Notice informs facility officials of their right to
claim as confidential business information any information (documents,
physical samples, or other material) collected by the inspector. The
inspector should also show the facility officials his letter from the
Deputy Administrator for General Enforcement certifying that he is
authorized for access to confidential business information.
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Authority to Make Confidentiality Claims
The inspector must ascertain whether the facility official to whom the
Notice was given has the authority to make business confidentiality claims
for the company. The facility official's signature must be obtained at
the appropriate place on the Notice certifying that he does or does not
have such authority.
• The facility owner is assumed to always have the authority
to make business confidentiality claims. In most cases, it
is expected that the agent in charge will also have such
authority. It is possible that the officials will want to
consult with their attorneys (or superiors in the case of
agents in charge) regarding this issue.
• If no one at the site has the authority to make business
confidentiality claims, the Notice and accompanying forms
(see Section 5: Closing Conference) are to be sent to the
chief executive officer of the firm within two days of the
inspection. He will then have seven calendar days in which
to make confidentiality claims.
• The facility official may designate a company official in
addition to the chief executive officer who should also
receive a copy of the Notice and accompanying forms. Space
is provided on the Notice form to make such a designation.
Confidentiality Discussion
Officials should be informed of the procedures and requirements that
EPA must follow in handling TSCA confidential business information.
The inspector should explain that these procedures were established
to protect the companies subject to TSCA and cover the following
points during the disucssion:
• Data may be claimed confidential business information during
the closing conference if a person authorized to make such
claims is on-site at the facility.
• It is suggested that a company official accompany the in-
spector during the inspection to facilitate designation
(or avoidance, if possible) of confidential business data.
• A detailed receipt for all documents, photographs, physical
samples, and other materials collected during the inspection
will be issued at the closing conference.
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• An authorized person nay make immediate declarations that some
or all of the information is confidential business information.
This is done by completing the Declaration of Confidential
Business Information form. Each item claimed must meet all
four of the criteria shown on the Notice and Declaration forms.
• If no authorized person is available on-site, a copy of the
Notice along with the Receipt for Samples and Documents will
be sent by certified, return-receipt-requested mail to the
chief executive officer of the firm, and to another company
official, if one has been designated.
—Claims of confidentiality must be sent by registered
return-receipt-requested mail to the appropriate EPA
office within seven calendar days of receipt of the
Notice. (The inspector will insert the name and
address of the Regional Document Control Office in
the appropriate place on the Notice.)
• All data claimed confidential will be turned to the Document
Control Officer and treated in accordance with procedures
described in the TSCA-CBI Security Manual. Only authorized
persons will have access to the information.
• Data not immediately claimed confidential business information
because no authorized person is available on-site will be kept
in locked storage and otherwise accorded confidential treatment
(routine security measures) until the seven-day period has
expired. The information will not be logged in by the Document
Control Officer until an actual business confidentiality claim
has been made.
Preparation/Distribution of Confidentiality Forms
When the TSCA Confidentiality Notice is completed, four or five copies
are made and distributed as follows:
• Facility owner or agent-in-charge
• Company chief executive officer* (if no authorized person
is available)
• Other company official* (if designated)
• Inspection report
• Inspector's files
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*If the Notice is to be sent to the chief executive officer (and other
company official, if designated), attach a copy of the completed
Receipt for Samples and Documents and a partially completed Declara-
tion form. Mail within two days of the inspection. (See Section 5:
Closing Conference, for a complete discussion.)
Three or four copies are made of the Declaration of Confidential
Information form and distributed as follows:
• Facility owner or agent in charge
• Other company official (if designated)
• Document Control Officer
• Inspection report
Other Considerations
Duplicate Samples
Facility officials should be informed during the opening conference of
their right to receive a duplicate of any physical sample tliquid or solid)
collected for laboratory analysis. Officials should indicate at this point
the desire to receive duplicate samples so arrangements can be made to
secure the samples during the inspection.
Photographs
The inspector may take photographs during the inspection. If officials
object to the use of cameras in their facilities, it should be explained
in a tactful manner that the photographs will result in a more thorough
and accurate inspection report. Officials may declare as confidential
business information any photographs taken during the inspection. If
polaroid/instant photographs are taken, they can be reviewed during the
closing conference.
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Chapter Three
Introduction
4a
Sampling and
Documentation
Reviewing facility records, taking physical samples, and preparing
documentation are the basic elements of a compliance inspection. These
activities provide the evidentiary support the Agency uses to initiate
enforcement actions.
In the overall enforcement process, the inspector plays the key role of
providing reports and evidence that will withstand legal scrutiny.
Authority
Section 11 (a) of the Act establishes the authority to inspect for TSCA
compliance. Included within the scope of TSCA inspections are samples,
records, files, papers, and photographs. In carrying out these functions,
the inspector acts as the duly designated representative of the EPA
Administrator.
Objectives
The primary objective of sampling and documentation is to provide the
Agency with accurate and complete substantiation of violations that can
be admitted as evidence in a legal proceeding.
Development of admissible evidence is a complex process with many inter-
related facets. Evidence must be factual and objective; it must be
relevant and comprehensive; and it must be developed within the scope
of the law.
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4a Introduction to Sampling and Documentation
The inspector's primary responsibility is to ensure that all evidence
is prepared so as to be admissible in court. The procedures outlined
in this Section will guide the inspector through this process.
In the evidence-gathering process, two considerations are of vital
importance:
• Observance of Policy and Procedures. Specific procedures and
policies have been developed to ensure efficient and effective
evidence gathering. These procedures, which encompass the
many individual components of sampling and documentation activities,
are detailed to help ensure that evidence generated by in-
spectors will be admissible in court. Inspectors are expected
to follow these procedures.
• Inspecting within the Scope of the Law. Specific requirements
have been established to protect all parties involved in an
inspection—facility, Agency, and inspector. It is imperative
that inspectors operate within these requirements to avoid
endangering a case on procedural or legal grounds.
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Chapter Three
4b
Records
Inspection
The Toxic Substances Control Act requires that manufacturers, processors,
and distributors of chemical substances maintain specific records
relating to data that would aid EPA in identifying and monitoring
toxic substances.
These requirements include reports of adverse reactions to health or
to the environment, and the creation and retention of records relating
to rules and regulations promulgated under the Act. Details of these
requirements are listed in specific Volumes of this manual.
Objectives
The basic purpose for inspecting facility records is to determine
compliance with TSCA requirements. The primary objectives of records
inspection are:
• To determine whether records required by the Act, or by
rules promulgated under the Act, are being adequately
maintained.
• To aid in determining the scope and objectives of the facility
inspection and to coordinate documentation of on-site observations
and sampling activities
Industry maintains various systems to document the procedures, methods
of manufacture, distribution, quality control, and other functions
undertaken in the manufacture or handling of toxic substances. Although
records are required, no specific recordkeeping system or formats are
detailed under TSCA. An effective facility inspection must be planned to
consider what kinds of recorded information are necessary to aid in
establishing compliance with TSCA requirements.
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4b Records Inspection
Inspectors should clearly establish the objectives of the inspection
to avoid a cumbersome review of irrelevant materials. Records in-
spection should be clearly tied to the overall goals of the particular
inspection being undertaken.
Types of Records
The inspector may need to examine the following types of records:
•
Annual reports
•
Production records
•
Shipping records
•
Inventory records
•
Sales records (invoices, receiving records, etc.)
•
Process records
•
Quality control records
•
Disposal records
•
Label and literature
•
Permits—state, local, and federal
•
Correspondence
•
Exemptions
Information Retrieval Systems. Inspectors will encounter many elec-
tronic and Visual systems for storing information needed for an in-
spection. Computers, microfilm, microfiche, and other systems will
not pose retrieval problems if the inspector has carefully established
inspection objectives and knows the type of information he is looking
for.
Details of copying and handling these types of information are out-
lined below.
Procedures and Considerations
Accurate and complete records inspection entails a number of procedural
steps, including targeting, locating, copying, and handling.
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4b Records Inspection
When reviewing records, inspectors should enter into the field notebook
the kinds of records examined, and the reasons for examining them.
Particular attention should be paid to the quality of information being
reviewed. When reviewing records, the following questions should be
kept in mind:
• Is the information complete?
• What are alternative sources for the same information?
• Has the facility made an honest attempt to meet TSCA record-
keeping requirements?
In addition, inspectors should look at records in terms of the following
general considerations:
• Compare current with past reports for possible discrepancies
or false reports.
• Check for completeness and accuracy of required records and
reports.
• Ascertain compliance with record retention requirements.
• Compare information contained in the records with first-hand
observations.
Guidelines for inspecting records under substance-specific regulations are
provided in the other Volumes of this Manual.
Targeting and Locating Records
The specific inspection objectives will help determine exactly what records
and/or information the inspector will need to examine. In this process,
the inspector should:
• List the kinds of records needed for compliance, and their
retention requirements. (Refer to the substance specific
Volumes of this manual and to the related regulations for
guidance.)
• Become familiar with the firm's record-keeping system. (A
field report entry about the system may help with future
inspections.)
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• Establish priorities for the material to be reviewed.
• Request that records personnel point out pertinent files
and sources.
• Check back-up systems and cross-filing systems which may make
retrieval more efficient.
There is often more than one route to the information needed for an
inspection. Different firms may organize data in different ways.
Inspectors should be aware of alternative approaches to data retrieval.
For example, a firm may consider disposal records to be a subcategory
of its shipping or transportation file system.
Copying Records
Records and files may be stored in a variety of information retrieval
systems, including written or printed materials, computer or electronic
systems, or visual systems such as microfilm and microfiche.
When copies of records are necessary for an inspection report, storage
and retrieval methods must be taken into consideration:
• Written or printed records can generally be photocopied on-site.
Portable photocopy machines may be available to inspectors
through the Regional Office. When necessary, however, in-
spectors are authorized to pay a facility a "reasonable" price
for the use of facility copying equipment.
• At a minimum, all copies made for or by the inspector should
be initialed and dated for identification purposes. (See
Identification details below.)
• When photocopying is impossible or impracticable, close-up
photographs may be taken to provide suitable copies.
• Computer or electronic records may require the generation of
"hard" copies for inspection purposes.
• Arrangements should be made during the opening conference,
if possible, for these copies.
• Photographs of computer screens may possibly provide
adequate copies of records if other meains are impossible.
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4b Records Inspection
• Visual systems(microfilm, microfiche) usually have photocopying
capacity built into the viewing machine which can be used to
generate copies.
• Photographs of the viewing screen may provide adequate
copies if "hard" copies cannot be generated.
Identification Procedures
Immediate and adequate identification of records reviewed is essential
to ensure the ability to identify records throughout the Agency cus-
tody process and to ensure their admissibility in court. When in-
spectors are called to testify in court, it is imperative that they
be able to positively identify each particular document and state its
source and the reason for its collection.
Initial, date, number, and write in the facility's name on each record,
and log these items in the field notebook.
• Initialing Dating. Each inspector should develop a unique
system for initialing (or coding) and dating records and
copies of records so that he can easily verify their validity.
This can be done by initialing each document in a similar
position, or by another method, at the time of collection.
Both the original and copy should be initialed. All record
identification notations should be made on the back of the
document.
The inspector must be able to positively identify that he
so marked the document.
• Numbering. Each document or set of documents substantiating a
suspected violation or violations should be assigned an
identifying number unique to that document. The number
should be recorded on each document and in the field notebook.
• Logging. Documents obtained during the inspection should be
entered in the field notebook by a logging or coding system.
The system should include the identifying number, date, and
other relevant information:
« The reason for copying the material (i.e., the nature of
the suspected violation or discrepancy).
o The source of the record (i.e., type of file, individual
who supplied record).
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4b Records Inspection
• The physical location of the record (i.e., address of
the facility, building number, room number).
• The manner of collection (i.e., photocopy, other
arrangements).
General Considerations
• Return originals to the proper personnel or to their
correct location.
• Keep related records grouped together.
• Confidential business records should be handled according to
the special confidential provisions discussed below.
• All copies of records are to be delivered to the case pro-
ceedings file after completion of the inspection.
• All records are to be kept under lock when not in actual
use by the inspector.
Confidentiality Considerations and Procedures
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
completion of the inspection.
Preliminary Indications of Confidentiality
Under ideal circumstances, a facility official will accompany the
inspector and make preliminary indications of the business information
considered confidential.
Such information should not be entered into field notebooks; a non-
confidential reference should be made to the information and the in-
formation should be placed on separate sheets which are then to be
considered documents. When the facility official is unwilling or un-
able to make such preliminary indications, the inspector must exercise
judgment in deciding which information should not be entered into the
field notebook.
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4b Records Inspection
Manual Copying of Records
Only that information essential to the inspection should be copied
manually from facility records. If it is known or suspected that a
business confidentiality claim might be made, a reference only should
be made in the field notebook and the information placed on separate
sheets of paper. This treatment of the information will permit it to
be placed on the Receipt for Samples and Documents,iust as photocopies
are listed.
Photocopying Documents
If only some information is needed from facility records to be photo-
copied, it is suggested that potentially confidential portions not
necessary to the inspection be shielded.
To ensure that such shielded copies will be admissable as evidence if
needed, the inspector should obtain the signature of the facility
official on the back of the photocopy under a statement which reads:
"I hereby acknowledge that this is a photocopy of a page from our
(kind of record). A portion of the page was shielded and not photo-
copied at the company's request."
Facility Official Signature
Date
For long documents, one statement listing the relevant pages may be
substituted.
Identification of Confidential Documents
Each page of each document copied either manually or by photocopy should
by stamped "Confidential Business Information" as soon as confidentiality
is claimed.
The document(s) should be placed inside an envelope also marked
"Confidential Business Information." This envelope should be placed
inside a plain envelope and mailed immediately to the Document
Control Officer in the Regional Office. See Section 6: Security
Procedures, for a detailed discussion of the treatment of confidential
business information.
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Chapter Three
4c
Documentary
Support
Objective
Providing strong documentary support of discrepancies uncovered in an
inspection is a basic responsibility of an inspector. Documentation
serves to "freeze" the actual conditions existing at the time of the
inspection so that evidence may be examined objectively at a later
date by case proceedings personnel.
Documentation is a general term referring to all print and mechnical
media produced, copied, or taken by an inspector to provide evidence
of suspected violations. Types of documentation include the Field
Notebook, Statements, Copies of Records, Photographs, Drawings and
Maps, Printed Matter, and Mechnical Recordings.
Inspector's Field Notebook
The core of all documentation relating to an inspection is the field
notebook, which provides accurate and inclusive documentation of all
inspection activities. The notebook will form the basis for written
reports and should contain only facts and pertinent observations.
Language should be objective, factual, and free of personal feelings
or terminology which might later prove embarrassing. Notebooks become
an important part of case proceedings evidence and can be entered in
court as evidentiary material.
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4c Documentary Support
Confidentiality Considerations and Procedures
Some of the information that an inspector would ordinarily include in the
field notebook may be considered confidential business information by
the company. During discussions with facility officials, the inspector
should avoid topics involving potentially confidential information not
needed for completion of the inspection.
If information claimed or suspected to be claimed confidential is obtained
(either orally or copied from facility records), such information should
be referenced in a non-confidential statement in the field notebook and
placed on separate sheets of paper that are then treated as documents.
Photocopied documents should be referenced in the same manner.
• The non-confidential statement should state generally what
information has been collected (i.e., "information about the
firm's process for making x chemical").
• The separate sheets should be headed by the reference statement
in the field notebook and identified by the name of the facil-
ity, date of inspection, and inspector's signature. The
sheets should contain data only; no observations of extraneous
notes should appear since the sheets will be reviewed by
facility officials.
• The sheets are described as documents on the Receipt for Samples
and Documents which is given to facility officials at the closing
conference.
• The sheets are described as documents on the Receipt for Sam-
ples and Documents given to facility officials at the closing
conference.
• The sheets can be reviewed by the facility officials during
the closing conference and declared confidential, as appropriate.
It is recognized that the inspector will not always be able to make a
prior determination about confidential business information before
making entries into the field notebook, and that potentially confiden-
tial data may be included in the regular field notes. The intent here
is to reduce, to the extent possible, such entries so that later diffi-
culties regarding the fiela notes can be avoided. (See Section 5:
Closing Conference, and Chapter Four, Section 1: Report Preparation,
for discussions of confidential information contained in field notes.)
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Chapter Three
4c Documentary Support
Inspection Entries
Since an inspector may be called to testify in an enforcement proceeding,
it is imperative that each inspector keep detailed records of inspections,
investigations, samples collected, etc. Types of information that should
be entered into the field notebook include:
• Observations. All conditions, practices, and other observations
that will be useful in preparing the inspection report or will
contribute to valid evidence, should be recorded.
• Procedures. Inspectors should list all procedures followed
involving entry, sampling, records inspection, and document
preparation. Such information will help avoid damage to
case proceedings on procedural grounds.
• Documents. All documents taken or prepared by the inspector
should be noted and related to specific inspection activities.
(For example, photographs taken at a sampling site should be
listed, described, and related to the specific sample number.)
• Unusual Conditions and Problems. Unusual conditions and problems
should be noted and described in detail.
• General Information. Names and titles of facility personnel and
the activities they perform should be listed along with statements
they may have made and other general information. Information
about a facility's recordkeeping procedures may be useful in
later inspections.
Administrative Entries
These entries provide documentation relating to travel
data. All information requested by the Travel Voucher
be listed in the notebook.
The field notebook is a part of the Agency's files and
considered the inspector's personal record. Notebooks
definitely pending disposition instructions.
Statements
Inspectors can obtain statements from persons who have personal, first-
hand knowledge of facts pertinent to a potential violation. This statement
of facts is signed by the person who can testify to those facts in court,
and it may be admissible as evidence.
and other fiscal
(SF 1012) should
are not to be
are held in-
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Chapter Three 4c Documentary Support
Objective
The principal objective of obtaining a statement is to record in
writing, clearly and concisely, relevant factual information so that
it can be used to document an alleged violation.
Procedures and Considerations
• Determine the need for a statement. Will it provide useful
information? Is the person making the statement qualified to
do so by personal knowledge?
• Ascertain all the facts and record those which are relevant and
which the person can verify in court. Make sure all information
is factual and first-hand. Avoid taking statements that can
not be personally verified.
• In preparing a statement:
• Use a simple narrative style; avoid stilted language.
• Narrate the facts in the words of the person making the
statement.
• Use the first-person singular ("I am manager of...").
• Present the facts in chronological order (unless the
situation calls for other arrangement).
• Positively identify the person (name, address, position).
• Show why the person is qualified to make the statement.
• Present the pertinent facts.
• Have the person read the statement and make any necessary
corrections before signing. If necessary, read the state-
ment to the person in the presence of a witness.
• All mistakes that are corrected must be initialed by
the person making the statement.
• Ask the person making the statement to write a brief con-
cluding paragraph indicating that he read and understood the
statement. (This safeguard will counter a later claim that
the person did not know what he was signing.)
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4c Documentary Support
• Have the person making the statement sign it.
• If he refuses to sign the statement, elicit an acknowledgement
that it is true and correct. Ask for a statement in his own
hand ("I have read this statement and it is true, but I am
not signing it because..."). Failing that, declare at the
bottom of the statement that the facts were recorded as
revealed and that the person read the statement and avowed
it to be true. Attempt to have any witness to the statement
sign the statement with his name and address.
• Provide a copy of the statement to the signer if requested.
Photographs
The documentary value of photographs ranks high as admissible evidence.
Clear photos of relevant subjects, taken in proper light and at proper
lens settings provide an objective record of conditions at the time of
inspection.
Inspectors should make certain that all equipment is in good working
order prior to an inspection, and that supplies are adequate. Film is
adversely affected by temperature extremes and care should be taken
to avoid unsuitable storage conditions (e.g., an overheated auto).
Polaroid-type instant photos should be identified immediately with
location, purpose, date, time, inspector's initials, and related sample
number (if applicable). Identification should be recorded on the photo
and in the field notebook. Photographs taken on film requiring
developing should be identified in the field notebook in the order they
are taken. Once developed, identification should be transferred to
the photo itself.
Scale, Location, and Direction
It is sometimes useful to photograph a subject from
indicate the location and direction of the subject,
object of known size (e.g., a person, an auto) will
approximate size of the subject.
Safety
In areas where there is a danger of explosion, flash photographs should not
be taken. If there is a danger of electrical shock, photographs should be
taken from a distance known to be safe.
a point that will
The addition of an
help indicate the
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Chapter Three
4c Documentary Support
Confidentiality Considerations
To avoid difficulties arising from confidential claims surrounding photo-
graphs, it is 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 be used. If not, and a confidentiality
claim is made, the film must be processed by a contractor authorized for
access to confidential business information.
Drawings and Maps
Schematic drawings, maps, charts, and other graphic records can be
useful in supporting violation documentation. They can provide graphic
clarification of site location relative to the overall facility, spill
or contamination parameters, relative height and size of objects, and
other information which, in combination with samples, photographs, and
other documentation, can produce an accurate, complete, evidence
package.
Drawings and maps should be simple and free of extraneous details. Basic
measurements should be included to provide a scale for interpretation
and compass points should be included.
Printed Matter
Brochures, literature, labels, and other printed matter may provide
important information regarding a firm's conditions and operations.
These materials may be collected as documentation, if in the inspector's
judgment, they are relevant.
All printed matter should be identified with date, inspector's initials,
and related sample numbers
Mechanical Recordings'
Records produced electronic or by mechanical apparatus can be entered as
evidence. Charts, graphs, and other "hard copy" documents should be
treated as documentation, and handled accordingly.
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Chapter Three
4d
Physical
Samples
Samples play a fundamental role in the TSCA enforcement process. It is
upon the analysis of samples that most enforcement actions are based.
Samples should be obtained when an inspector needs to establish that a
violation exists. There are two classifications of samples:
Physical Samples
Physical samples represent a substance as drawn from a container. Physical
samples also include environmental samples such as soil, water, air, or
sediment, or biological samples including animals and vegetation. They
are used to confirm the presence and concentration of a chemical substance.
This classification involves the majority of samples taken during an
inspection. The procedures for proper physical sampling are discussed
in detail in this section. Instructions for sampling to document specific
violations are contained in subsequent volumes.
Documentary Samples
There will be occasions during inspections when taking physical samples
is impossible or is not feasible. (For example: substances stored in
bulk, pressurized containers, or in containers which can not be opened,
such as capacitors.) In such cases, documentary samples can be prepared.
A documentary sample differs from a physical sample in that the sub-
stance itself is not collected. Thorough documentation of conditions
and observations surrounding the substance thus becomes even more
crucial.
Preparation of documentary samples involves the procedures detailed in
the preceding section on Documentary Support.
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Chapter Three
4d Physical Samples
Sampling Program
An inspector must be able to identify the sample examined in the laboratory
as the same sample he collected. The inspector must also be able to
explain and justify his sampling procedures. Mistakes or deficiencies in
procedures may damage an enforcement action. An organized, well-planned
sampling program will be of crucial importance in meeting this objective.
The substance-specific inspection Volumes provide details on how to sample.
However, an effective program will contain the following general elements:
• Definite Purpose.
• Representative Sample.
• Proper Equipment and Technique.
• Sufficient Volume.
• Controlled Identification.
• Proper Handling.
• Adequate Documentation.
Definite Purpose
The inspector should have a clear, definable purpose for taking a particu-
lar sample and should note this purpose in the field notebook. This in-
formation will help in determining the types of documentation and sampling
techniques required. It will also prove invaluable in the preparation for
testimony at a future date.
Representative Sample
Proper sampling procedures demand selection of a site or a number of
samples that will produce a representative sample. Specific techniques
will vary with particular requirements and are discussed in the specific
inspection Volumes. Notes should be made regarding site selection, and
further documentation (e.g., photos or drawings) would be used to support
the physical samples.
Proper Equipment and Technique
The use of proper equipment is essential in the collection of valid physical
samples. The various substances and sample types will require different
types of equipment. A list of frequently used equipment appears on page
3-5; the specific inspection Volumes will provide lists of equipment
and tools that are compatible with the substance being sampled.
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Chapter Three
4d Physical Samples
Care should be taken to prepare the equipment so that contamination is
avoided. The use of disposable sampling equipment, when practical, will
help minimize this risk. If disposable equipment is not used, care should
be taken to assure that sampling equipment is properly decontaminated.
All steps followed in sampling should be noted in the field notebook.
Sufficient Sample Volume
The amount of volume of the sample taken should be sufficient to per-
form all required laboratory analyses plus an additional amount for
quality control and repeat testing. Specific volumes will vary with
the type of sample and the substance involved. The specific inspection
volumes will provide details.
If duplicate samples were requested during the opening conference, they
should be collected and handled in the same manner as official samples.
Controlled Identification
To maintain validity throughout the evidence gathering process, samples
must be accurately and completely identified. A sample passes through a
number of steps in this process, and there must be no question as to its
source or integrity when a sample is entered as evidence.
The following steps are important aspects of the sample identification
process:
1. Identifying the Sample. The following information should be entered
in the field notebook:
• Sample number
• Date of collection
• Collection method
• Description of sample, including color, texture, viscosity, etc.
• Duplicate samples, if provided
A tag or label should be affixed immediately to the sample container
showing:
• Sample number
• Date of collection
• Inspector's initials
• Sub-sample number, if appropriate
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Chapter Three
4d Physical Samples
2. Sealing the Sample. Once the sample has been collected and labeled,
its container should be placed inside a plastic bag on which the
inspector has written his name or initials, and the date. The bag
is to be turned inside out to prevent any means of tampering with
the contents. The bag is then taped closed in a secure manner with
the Official Sample Seal (EP Form 7500-2). The seal should be
completed as follows:
UNITED STATE!
environmental protection agency
INSPECTOR'S SEAL
SAMPLE NO ^
o* re ^
SIGNATURE m
4
Ł6
6
3
PRINT NAME AM0 TITLE f/n«p.
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Chapter Three
4d Physical Samples
Identification Considerations
• One sample number is used for each sample. One sample consisting
of several subsamples or units is assigned only one number.
• Subsamples may be sealed in a single bag if they are part of one
sample and if adeguate packaging protection is provided.
• Sample numbers should appear on all documentation relating to a
sample: Seals, Chain of Custody Record, drawings, photographs,
etc.
Proper Handling
Samples must be handled, stored, and shipped properly to avoid loss, con-
tamination , danger to handlers, and tampering. Requirements for handling
specific substance samples are contained in the substance specific Volumes.
General considerations include:
• Samples should always be handled in accordance with safety
procedures that relate to the specific substance.
• Provisions for sample preservation (refrigeration, chemical
preservatives, proper packaging materials, etc.) should be
planned in advance of actual sampling.
• Recommended holding times for specific samples should be
determined and care taken to avoid delays in transit.
• Highly toxic substances may require special handling and
such arrangements should be made in advance, if possible.
• Security provisions should be adeguate to protect both
samples and documents.
• Samples can be delivered to the laboratory by the inspector.
When this is not feasible, they should be shipped by the
most economical means commensurate with the need for rapid
handling. All shipments are to be in accordance with U.S.
Postal Service and Department of Transportation regulations.
• Handling and shipping procedures followed should be recorded to
document the integrity of the sample.
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Chapter Three
4d Physical Samples
• Copies of all shipping and handling documents should be obtained
(e.g., bills of lading, return receipts, etc.).
Adequate Documentation
Sufficient and valid documentation of physical samples is as important as
the sample itself. The inspector's field notebook should serve as the
core of documentation with notations of all sampling activities clearly
listed.
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Chapter Three
4e
Chain of Custody
As in any activity that may be used to support litigation, regulatory
agencies must be able to prove that any analytical data offered into
evidence in a court accurately represents conditions at the time of
collection. Case proceedings personnel must be able to demonstrate
that none of the samples involved have been tampered with or con-
taminated during collection, transit, storage, or analysis. An
accurate written record must be maintained to trace the possession of
each sample from the moment of collection through its introduction
into evidence.
Elements of Custody
A sample is in "custody" if:
• It is in one's actual physical possession.
0 It is in one's view.
• It was in one's physical possession and it was secured so
it couldn't be tampered with.
• It is kept in a secured area with access restricted to
authorized personnel only.
• It is placed in a container sealed with an Official Seal
(Form 7500-2) that will be broken when the container is opened.
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4e Chain of Custody
Chain of Custody Procedures
The concept of custody requires the maintenance of several procedures to
ensure the integrity of the sample. These procedures begin with the
identification of the sample and continue through the laboratory
analysis process.
1. Establishing Custody. Sample custody is initialed at the time
of collection by sealing the sample with the Official Seal. The
process is described in Section 4d.
2. Preparing Sample Documentation. A major aspect of the Chain of
Custody is the preparation and maintenance of written information
describing the collection, shipment, and storage of the sample.
Preparation of this documentation is the responsibility of the
inspector and lab personnel. Properly maintained, this documen-
tation will serve as a clear and complete account indicating the
sample has remained intact from collection to introduction as
evidence.
The documentation includes the entries in the inspector's field
notebook, the Official Seal, and the Chain of Custody Record.
3. Coordinating Sample and Documentation. The inspector must assure
that the relationship between the physical sample the related
documentation is clear, complete, and accurate. The sample
number, date, and inspector's initials should appear on all
documents, and the forms should be completed accurately and
completely.
4. Ensuring Custody during Transit. Shipment of sample to the
laboratory will involve the following procedures:
• Samples must be accompanied by the Chain of Custody
Record. Copies of documents should be retained by
the originator.
• If sent by common carrier, a bill of lading should
be obtained.
• All receipts and shipping documents should be included
in the Chain of Custody documentation.
The forms described in these procedures can be found in Chapter
Six: Forms. Detailed instructions for completion are included.
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Chapter Three
4e Chain of Custody
Confidential Samples
If a sample has been declared confidential business information, the seal
is marked "Confidential Business Information," The chain of custody form
is also marked "Confidential Business Information," and any analysis
reports are also to be marked and held confidential.
It is essential that the inspector deliver or ship the confidential sample
to an individual in the laboratory who has been cleared for access to con-
fidential information. Each person who handles the sample and analysis
report from that point must also have confidentiality clearance.
The forms described in these procedures can be found in Chapter Six:
Forms - detailed instructions for completion are included.
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Chapter Three
4f
Health
and Safety
The handling and sampling of toxic chemical substances always poses a
certain degree of hazard. The objective of this section is to assure
the safety of persons handling hazardous materials by the use of
proper safety equipment and proper working habits. Most of the equip-
ment listed here is available from scientific supply houses listed in
the telephone directory.
Inspector Responsibilities
It is the responsibility of each inspector:
• To be thoroughly familiar with all safety guidance and
practices, and to make the appropriate choice of safety
equipment.
• To maintain safety equipment in good condition and proper
working order.
• To use safety equipment in accordance with guidance
received, labeling instructions, and as dictated by common
sense.
Personal Protective Equipment
Inspectors should have the following safety equipment and use it for
protection when handling chemical substances:
• Safety glasses (prescription if required), goggles, and face
shield.
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• Rubber-soled, non-skid, metal-toed shoes.
• High-top shoes or boots for field work.
• Gloves: liquid-proof, natural rubber or synthetic rubber,
disposable, if possible. The gloves should be long enough to
protect the wrist and be worn under the sleeves to prevent
chemicals from running into the gloves from the sleeves.
• Coveralls should be of closely woven fabric and be spill-
resistant; disposable if possible. If they are not, a liquid-
proof apron should be worn over them.
• Rubber apron, long enough to provide adequate protection.
• Hard hat.- plastic with a plastic sweatband. (Cloth and leather
sweatbands are more comfortable, but are harder to clean.)
• Shoe covers: plastic, disposable.
• Respiratory protective devices should be used whenever a toxic
contaminant is present or whenever there is an oxygen deficiency.
When using these devices, care should be taken to follow device
instructions carefully. In all cases, the equipment must be of
the type approved by either the National Institute of Occupational
Safety and Health (NIOSH) or by the Mine Safety and^Health
Administration (MSHA).
• Self-Contained Breathing Apparatus (SCBA). This type of
unit can be used in most cases when respiratory protection
is needed. Since this unit has its own supply of oxygen, it
has more flexibility in use than other types. If SCBA is too
expensive for regular use, it should be available for use in
emergencies.
• Chemcial Cartridge Respirators. This type covers the mouth
and nose. Some are available with goggles to protect the
eyes. If they are not, separate goggles should be worn.
Inhaled air comes through a filter pad and a cartridge made
to absorb vapors. Most harmful vapors, gasses, and
particles are removed.
• Chemical Canister Respirators (Gas Masks). This type
usually covers more of the face than the cartridge respirator
and has longer-lasting absorbent material and filters.
Neither kind will protect when oxygen supply is low.
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The respirator must fit the face well. A beard, heavy side-
burns, or glasses may prevent a good seal. Check the seal by
covering the air intake and breathing in. If no air enters,
there is a good seal. Tanks, cartridges, and filter units
should be checked and maintained in accordance with manufacturer
instructions. The face piece should be washed regularly.
The table which follows this section provides more information
on respiratory protective devices.
General Safety Equipment
The following safety equipment should be in each inspector's car for use
when needed. All equipment should be checked periodically to ensure that
it is in proper condition.
• First-aid kit
• Fire extinguisher (ABC all purpose dry chemical)
• Airtight containers for storage of highly toxic samples
• Hand cleaner and towels
• Clean water for washing in case of an accident
• Emergency phone numbers (See Table following this Section)
Handling of Chemical Substances: General Guidelines
The following guidelines should be followed when handling or sampling
chemical substances. When extraordinary circumstances exists, such as
handling of spills or highly toxic substances, guidance and direction must
be sought from your supervisor.
• Before entering any facility, ask the appropriate representative
if there are any special safety precautions that should be taken
or if there is any special safety equipment needed.
• Check all labels, manifests, and other sources of information
before sampling a chemical in an effort to identify the
substance and learn of potential hazards.
o Determine what routes of exposure to avoid for the chemical
substance being sampled, and the proper sampling and protective
equipment to be used.
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• Use only proper tools for opening containers (e.g. non-sparking
bung wrench) and be careful when opening and closing them.
• Exercise caution; the substance may be mislabeled.
• Open and sample substances in areas where spills can be cleaned
up easily and properly.
• Make use of all appropriate protective clothing and equipment.
• Be careful not to spill toxic substances on the skin or clothing.
If it happens, disrobe completely in a manner that keeps contact
with the substance to a minimum, and wash the skin thoroughly
for at least 15 minutes. A change of clean clothing should
always be available.
• After exposure, remove all protective gear and dispose of it
properly. Wash hands immediately after sampling, before eating,
smoking, drinking, or using toilet facilities.
• Never use your mouth to siphon or put your hands near your
eyes or mouth. Use an automatic syphon.
• A supply of detergent soap, clean water, and waterless hand
cleaner should be readily available.
• Know the limitations of your protective equipment, especially
respirators.
• Transport and store samples in an airtight storage box.
• Be alert for spilled materials, improperly stacked materials,
moving equipment (fork lifts, conveyor belts, etc.), poor
ventilation, bad lighting, etc.
Emergency Treatment
The purpose of emergency treatment is to give immediate and temporary care
to a victim of an accident or sudden illness until the services of a
physician can be obtained. In the case of poisoning, emergency treatment
helps to remove, dilute, or slow up the movement of the poison. Knowledge
of the poison combined with prompt treatment is essential in reducing the
poison's concentration. Medical attention should be sought when appropriate.
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The following tables provide emergency treatment guidelines for
the four major routes of entry.
INHALATION
Breathing a gas, vapor, mist, fumes, or dust is the
most common form of accidental exposure.
Inhalation affects the lining of the air passages of
the nose, throat, and lungs, and usually results in an
irritation and may cause mild burns. The chemical may
enter the bloodstream through the lungs and be distri-
buted throughout the body tissue, causing a systemic
effect.
Sampling should always be done in a well-ventilated
area and respirators should be used.
EMERGENCY TREATMENT
• If still conscious, get out of the contaminated air
space immediately.
• If the victim is unconscious, he should be
removed at once from the contaminated area. All
rescuers should make sure they have proper res-
piratory equipment operational before attempting
rescue.
• If the victim is no longer breathing, mouth-to-
mouth resuscitation, artifical respiration, or
cardio-pulmonary resuscitation (CPRJ should be
begun immediately.
• Medical attention should be sought immediately.
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SKIN EXPOSURE
Some substances have the capacity to penetrate the
unbroken skin and enter the bloodstream.
Precautions to be used in sampling include:
• Wipe all residue off the containers after
filling them with the sample.
• Use proper procedures for removing contaminated
clothing.
• Skin should be washed immediately after removal
of contaminated clothing. Clothing should not be
worn again unless decontaminated.
• Wash skin with plenty of soap and water for a
minimum of 15 minutes.
• If clothing is contaminated, it should be removed
in such a way as to minimize further contact with
the substance.
• Get under a shower immediately and remove clothing
while showering. Certain substances are rapidly
absorbed through the skin. WASTE NO TIME.
• All contaminated parts of the body, including hair,
should be thoroughly decontaminated. It may be
necessary to wash repeatedly.
EMERGENCY TREATMENT
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EYE CONTACT
Eyes may be harmed by substances in either liquid or
vapor form.
Precautions to protect the eyes include:
• Wear goggles or face shield.
• Do not rub eyes at any time.
• Eye(s) should be washed immediately with plenty
of water. The eye should be held open and flooded
with water so that all surfaces are thoroughly
washed.
• Washing should continue for 15 minutes.
• Seek medical aid.
EMERGENCY TREATMENT
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INGESTION
Toxic amounts of a substance may be carried to the
mouth by hand when drinking, eating, or smoking.
Precautions include:
• Wash hands thoroughly before eating, drinking,
or smoking.
• NEVER pipette or siphon liquids by mouth.
• Do not bring hands into contact with the mouth
until hands have been thoroughly washed.
• Call Poison Control Center.
• Follow directions on label of susbstance
container.
• When petroleum products are involved, get
medical advice immediately.
• Induce vomiting unless an aspiration hazard (as
with petroleum products) is a predominant factor.
• Take an emetic to induce vomiting. A table
spoon of salt or powdered mustard in a glass
of warm water may be used.
• Drink plenty of water. Placing your finger
in your throat may also be effective in
inducing vomiting.
• Treatment should be continued until vomitus
is clear.
• Seek medical advice immediately.
EMERGENCY TREATMENT
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Decontamination of Protective Clothing
After use of protective clothing to prevent contact with toxic substances,
head coverings, coveralls, aprons, and gloves should be folded or turned
inside-out, then placed in a plastic bag, and sealed. Subsequently, these
items should be disposed of or washed. Face shields, goggles, respirators,
rubber gloves, and boots should be washed thoroughly with soap and water
between uses. Protective clothing which has been contaminated should be
disposed of by appropriate methods.
Long Term Risk
The possibilities for long term risk inevitably exist with the handling of
toxic substances. Although there are no defined measures to avoid these
risks, handlers of toxic substances should be warned of their dangers.
Among the many chemical substances and mixtures which are constantly being
developed and produced, there are some whose manufacture or use may
present an unreasonable risk of injury to health or to the environment.
For this reason the inspector should vigorously follow the long term
medical surveillance procedures of the Agency.
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INDUSTRIAL
AND MUTUAL AID EMERGENCY CONTACTS
Organization
Division
Hours
Telephone
Association of American
Railroads
Emergency Response
24-hour
(202)
293-4048
CHEMTREC
Chemical Emergencies
24-hour
(800)
424-9300
Dow Chemical
Emergencies
24-hour
(517)
636-4400
Du Pont
Emergency Response
24-hour
(302)
774-1000
Monsanto
Safety Office
24-hour
(618)
271-5835
National Foam Center
Emergency Response
24-hour
(215)
363-1400
Poison Control Center
24-hour
Consult White
Pages of Local
Telephone
Directory Under
"Poison Control"
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Health and Safety
RESPIRATORY PROTECTIVE EQUIPMENT
Atmosphere
Respirator Type
Applications and Limitations
Precautions
All particulates
gases, vapors,
oxygen
deficiency.
Self-contained.
Recirculating
compressed oxygen.
Demand compressed
air or oxygen.
Self-generating
oxygen.
Use in any atmosphere. Allows
freedom of movement, allows
worker to leave atmosphere by
any route. Limited time of use.
Careful training required for
proper use.
Wearer should be in good
physical condition and
thoroughly trained.
Assure plentiful supply
of air or oxygen in tank.
Check for proper and
tight fit, use with life
line. Leave at once if
an odor is detected. Do
not remove until out in
respirable air.
Supply air. Unlimited time of use, use in
Hose mask with any atmosphere (except air line
blower Hose not to be used in oxygen defic-
mask without lent or immediately dangerous
blower. atmosphere). Not to be used
Air line where worker cannot escape
respirator. unharmed without protection.
Must exit by entrance route.
150 ft. maximum from exit
(75 ft hose mask without
blower). Limits freedom of
movement.
Place inlet in respirable
air location, adjust fit
and air lines properly.
Test before entering
dangerous atmosphere.
Use life line, protect
air line or hose from
sharp edges or falling
objects. Leave at once
if air flow is interrupted
Do not remove until in
respirable air. Air line
respirators must have a
clean supply of air free
from dust, oil and carbon
monoxide.
Particulates
alone
Mechanical Filter.
Special filter
respirators.
Allow freedom of movement. Not
to be used in excessively
dusty atmospheres, in oxygen
deficient atmospheres, or in
atmospheres containing gases
or vapors. Not to be used
for abrasive blasting.
Relatively difficult to
breathe. Limited time of use.
Use clean filter and
change when plugged.
Ensure good fit and good
operating condition*
Leave at once if diffi-
culty in breathing
increases significantly.
Gases and Vapors
alone
Chemical
Absorbers.
Universal gas
mask.
Special canister
gas mask.
Special cartridge
respirator
Allows freedom of movement.
Do not use in atmospheres
deficient in oxygen or contain-
ing excessive contaminants
(above 2% with gas masks, above
1000 ppm with cartridge type).
Used for limited time and
specific contaminant only.
(Cartridge respirators not to
be used in atmospheres immed-
iately dangerous to life.)
Relatively difficult to breathe.
Limited time of use.
Adjust properly, ensure
good tight fit. Check
operating condition.
Always use fresh canister
or cartridge at start of
use if possible. Enter
atmosphere cautiously.
Whenever odor is detected
leave at once. Leave if
difficulty in breathing
increases significantly.
Combination of
particulates and
gases and
vapors
Chemical/Mech-
anical Filters.
Gas mask with
filter.
Filter respirator
with chemical
cartridge.
See mechanical filters and
chemical absorbers.
See mechanical filters
and chemical
absorbers.
Source: Sax, N. Irving, Dangerous Properties of Industrial Materials,
1960.
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Bibliography
The following is a partial listing of works on safety and a brief
summary of the information contained therein.
• "Occupational Safety and Health for the Federal Employee", U.S. Department of
Labor, Occupational Safety and Health Administration," January 1, 1979 A booklet
outlining Federal Government policy concerning occupational safety and health
protection provided for government employees.
• "NEIC Safety Manual," Environmental Protection Agency, Office of Fnforcement,
National Enforcement Investigation Center, EPA-330/9-74-002-B, Denver, Colorado,
February, 1977. Provides general guidelines on safety for NEIC personnel, con-
sistent with OSHA requirements.
• "Hygienic Guide Series/' American Industrial Hygiene Association, Akron, Ohio 44313,
March, 1977. Contains an alphabetical list of chemicals, with the following in-
formation for each, hygienic standards, significant properties, industrial
hygiene practice, specific procedures for safe handling and literature references.
• Handling Guide for Potentially Hazardous Commodities," ed David Baskin, Ph D.,
Commodity Safety System of the Railway Systems and Management Association. Contains
the following relevant information chemical synonym directory, medical digest,
pollution control, references, priority risk worksheet and emergency equipment.
• "Matheson Gas Data Book," The Matheson Company, Inc., East Rutherford, New Jersey;
Joilet, Illinois, Newark, California. Matheson of Canada, Ltd., Whitby, Ontario,
1961. Contains information on handling, use and recommended controls for gases.
Includes description, specification, toxicity, first aid, precautions in handling
and storage, container construction materials, cylinder and valve description,
safety devices, recommended controls, shipping regulations, commercial preparation,
chemical properties, and physical data.
• "CHRIS, A Condensed Guide to Chemical Hazards," Department of Transportation,
Coast Guard, October, 1978. Contains a directory of chemical names and the
following information for each: common synonyms, appearance, and general
response information outlining basic preventive and precautionary actions
to be taken.
• "Patty's Industrial Hygiene and Toxicology, 3rd Revised Ed., Volume I* General
Principles," ed. George D. Clayton and Florence E. Clayton, 1978. Twenty-seven
authorities in their respective fields discuss such facets of the profession as
air pollution; agricultural hazards, odors, heat stress; fire and explosion
hazards, atmospheric contaminants, pulmonary effects of inhaled dusts, noise
and conservation of hearing, and more. The book also includes methods of
evaluation of the various problems likely to be encountered, samples of
methods of record keeping, and hazard control methods.
• "Dangerous Properties of Industrial Materials," Newton Irving Sax, Reinhold
Publishing Corporation, New York, 1963, Third Edition Contains information
covering over 12,000 hazardous materials. Areas of hazard covered include:
radiation hazards, industrial fire protection, storage and handling of
hazardous materials, respiratory protection, and personal hygiene.
• "Condensed Chemical Dictionary," Arthur and Elizabeth Rose, Reinhold Publishing
Corporation, New York. Contains useful information on chemical materials including
shipping instructions and safety regulations.
• "Threshold Limit Values of Airborne Contaminants," adopted by ACGIH for 1969,
American Conference of Governmental Industrial Hygienists, 1014 Broadway,
Cincinnati, Ohio 45202.
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4f Health and Safety
• "American Red Cross First Aid Textbook," American National Red Cress, Doubleday
and Company, Garden City, New York, 1957.
• "Clinical Toxicology of Commercial Products," Marion N Gleason, ed , Williams
and Wilkins Company, Baltimore, 1957.
• "Alphabetical Index Industrial Safety Data Sheets," National Safety Council,
425 North Michigan Avenue, Chicago, Illinois 60611. Lists bulletins available
on characteristics of over 200 chemicals.
• Chemical Manufacturers Association, 1825 Connecticut Avenue, N.w. , Washington, D C.
20009. The CWA has many publications which give complete information on health
and fire hazards, handling, storage, labeling, packaging and transportation.
A list of publications is available.
• "Fire Protection Guide on Hazardous Materials," National Fire Protection
Association, 60 Batterymarch Street, Boston, Massachusetts 02110. This
recent publication is a complete volume on fire, explosion, and health
characteristics of many chemicals and materials. It combines five previous
NFPA texts (49, 491M, 325A, 325M, and 704M)„
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Chapter Three
5
Closing Conference
A final meeting with facility officials will enable the inspector to
"wrap up" an inspection. Necessary receipts can be prepared, questions
can be answered, and information gaps can be resolved.
Required Receipts
Receipt for Samples and Documents
A written receipt for all samples and documents taken should be issued
to the facility officials. The receipt should describe each item and
its point of origin and be signed and dated by the inspector. To be
included on the receipt are:
• A description of all physical samples taken.
• A description of all records, photographs, or other property
taken. This is particularly crucial when inspecting with
a warrant.
o A description of all separate sheets containing sensitive
information taken in lieu of entries in the field notebook.
The purpose of this detailed receipt is twofold:
• To protect the Agency by showing that facility officials knew
exactly what was taken.
• To allow full review by the facility officials of the material
and information collected so that confidentiality claims can
be made.
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Declaration of Confidential Business Information
The Declaration of Confidential Business Information should include a
list of all items declared confidential by an authorized facility
official. Each item declared must meet the four criteria shown on the
form.
• Some information may have been declared confidential during
the inspection itself. These items should be reviewed and
confirmed with facility officials and each item then listed
on the Declaration form.
• Facility officials then review the completed Receipt for
Samples and Documentation and make any further entries on
the Declaration form.
No Authorized Claimant. If no on-site facility official is authorized
to make confidentiality claims, the following steps should be followed:
• A copy of the completed Receipt for Samples and Documents
should be made.
• A copy of the TSCA Notice of Confidentiality that was signed
by the facility official should be made. The Notice should
include the name and address of the Regional Document Control
Officer in the place provided.
• A Declaration of Confidential Business Information form should
be partially completed (top portion and inspector's name and
title only).
• The three forms should be mailed by certified, return-receipt-
requested mail to the chief executive officer of the firm with-
in two days of the inspection. (The chief executive officer
will have seven calendar days to make confidentiality claims.)
• If another company official has also been designated to make
business confidentiality claims, the three forms should be
sent to him in addition to the chief executive officer.
• No additional measures beyond the routine security procedures
normally followed for inspection data need be taken with
regard to this information during the seven-day period.
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• TSCA-CBI procedures will commence immediately upon notification
of the Document Control Officer of a confidentiality claim.
If a confidentiality claim is made, it is the responsibility
of the Document Control Officer to notify all parties (in-
spector, laboratory, case preparation staff, and any others
who may be handling the information) and log in the material
as required.
Industry Outreach
Since the inspector is often the only contact between the Agency and
the regulated industries, he should be acutely aware of opportunities
to maintain and improve Agency-Industry relations. The closing con-
ference provides an ideal opportunity to offer various kinds of help
to facility officials. The inspector will have just completed an
inspection, and will have first-hand knowledge of questions, problems,
and ways to help overcome them. Considerations include:
• Answering all questions within the ability and authority of
the inspector.
• Referral of questions and problems to other EPA personnel
when necessary. Follow-up with those personnel when practical.
• Discussion of problems with facility officials, tactfully
offering help and suggestions.
• Tactful probing of problem areas uncovered during the inspection
which facility officials may not be aware of.
• Offering or suggesting available resources to facility
officials to help overcome problems (i.e., Agency outreach
materials, technical publications, special services
available to industry, etc.)
It is very important for the inspector—as an industry relations
representative—to follow up all referrals and offers for help. A
letter, phone call, or repeat visit will indicate to facility officials
a genuine interest on the part of the Agency. Such expression of
interest will immeasurably aid the Agency's industry relations and
voluntary compliance programs.
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Chapter Three
6
Security Measures
Overview
Security measures must be taken to protect all inspection data (including
documents, samples, field notes, and other documentation) collected by
the inspector. The information must be protected because:
• The very nature of an enforcement investigation assumes the
possibility that some legal action might result.
• Any inspection involves the collection of information that a
firm would not ordinarily make available to outsiders.
In addition to the routine security measures, which are always taken with
regard to inspection data, the declaration of certain information as TSCA
Confidential Business Information (TSCA-CBI) imposes a further layer of
security procedures designed to control access to the information within
the Agency.
Routine security measures and the additional procedures for TSCA Con-
fidential Business Information are discussed below.
Routine Security Measures
The main objective of the routine security measures is to ensure that
reasonable precautions are taken to prevent unauthorized persons from
viewing the information. When practical circumstances prohibit the in-
spector from following the procedures exactly, the inspector is expected
to take steps for protection of the information that will achieve this
obj ective.
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While Traveling
The inspector may be on the road for several days while doing inspections.
It is his responsibility to ensure that the information he collects is
handled securely.
• Documents and field notes are considered secure if they are
in the physical possession of the inspector and not visible
to others while in use. For example, it is permissible to
review documents in the privacy of a motel room or motor
vehicle, but not acceptable to review them in a public place
such as a restaurant.
• Inspection documents contain sensitive information and should
be kept in a locked briefcase. If it is impractical to carry
the briefcase into a given situation, the briefcase may be
stored in a locked area such as a motel roan or trunk of a
motor vehicle.
• Physical samples should be placed in locked containers and
stored in a locked portion of the motor vehicle. The chain
of custody procedures provide further protection for ensuring
the integrity of the sample.
In the Office
Documents and field notes must be kept in a locked filing cabinet when
not in actual use.
TSCA-CBI Security Procedures
In addition to all of the routine security measures that must be taken
for any inspection data, the further procedures discussed below must
be followed with regard to information declared TSCA Confidential Business
Information.
while Traveling
Because of the difficulties in protecting TSCA-CBI while traveling, it is
recommended that such information be mailed, shipped, or hand delivered
to an authorized person as soon as possible after the inspection.
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• Documents and other "paper" data should be mailed or hand
carried to the Regional Document Control Officer.
• Physical samples should be shipped or hand carried to an in-
dividual in the laboratory who is cleared for access to con-
fidential information.
Handling of Documents
• As soon as they are declared, confidential documents or papers
should be marked "Confidential Business Information" and placed
inside an envelope also marked "Confidential Business Information."
This envelope is placed inside a plastic envelope addressed
to the Regional Document Control Officer and mailed immediately.
• If mailing is not feasible immediately, the double envelope
should be placed inside a locking briefcase. The double
envelope is required during this interim period to prevent
others from seeing that the inspector is carrying "Con-
fidential Business Information1' should he open his brief-
case.
• The locked briefcase must be kept in the sight of the in-
spector at all times. If it is totally impractical to
carry the briefcase into a given situation, the briefcase
may be stored in a key-locked area for which the inspector
has control of the only key. The inspector would be ex-
pected to take the briefcase into a restaurant, but not
into another facility inspection. Briefcases should not
be left unattended in a motel room.
• If it is necessary for the inspector to review the document,
this can only be done in absolute privacy because the
"Confidential Business Information" marking is likely to
arouse curiosity. If privacy is violated, the documents
must be shielded from view immediately.
Handling of Physical Samples
• Physical samples declared confidential should be marked
"Confidential Business Information" on the seal and the
same mark should be placed on the chain of custody report.
The sample and chain of custody report should be shipped
or delivered immediately to an individual in the laboratory
who is known by the inspector to be cleared for confidential
business information.
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6
Security Measures
• If shipping is not feasible immediately, the samples should
be stored in a locked container inside a locking portion of
the motor vehicle.
In the Office
• If the inspector has confidential business information in his
possession from an inspection when he returns to the office,
he should check it in with the Document Control Officer (DCO)
immediately upon his arrival.
• The Document Control Officer should be informed of any physical
samples that were declared confidential. It is the respon-
sibility of the DCO to notify the laboratory of the Document
Control Number (DCN) assigned to the sample which should ap-
pear on the sample chain of custody and laboratory analysis
reports. If a copy of the laboratory analysis is sent to the
firm, it must be sent by registered mail in a double envelope.
• After the documents have been logged in by the DCO, they must
then be handled in accordance with the procedures detailed in
the TSCA-CBI Security Manual.
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Chapter Four
Post-Inspection
Activities
Chapter Contents Page
1 Report Preparation
Objective of the Inspection Report 4-1
Confidentiality Considerations and Procedures 4-2
Preparation of Inspection Report 4-2
Field Notes 4-2
Elements of the Report 4-3
Inspection Report Forms 4-3
Narrative Report 4-4
Reviewing the Information 4-4
Organizing the Material 4-4
Referencing Accompanying Material 4-5
Writing the Narrative 4-5
Narrative Report Format 4-6
2 Appearing as a Witness
Personal Appearance and Conduct 4-11
Witness Stand Technique 4-12
Speaking 4-13
Notes 4-13
Answering Questions 4-13
General Guidelines 4-14
Testifying under Cross Examination 4-15
Proper Conduct During Recess and After the Trial 4-16
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Chapter Four
1
Report
Preparation
The adequacy of an enforcement case depends on the evidence package pre-
pared by the inspector. The preceding chapter details the procedures for
collecting and substantiating this evidence. Once collected, however,
this evidence must be organized and arranged in a manner that will allow
case proceedings personnel to make maximum use of the information.
The information presented in this section provides general guidelines for
organizing evidence and preparing an inspection report.
Objective of an Inspection Report
The objective of an inspection report is to organize and coordinate all
evidence gathered in an inspection in a comprehensive useable manner.
In order to meet this objective, information in an inspection report
must be:
• Accurate. All information must be factual and based on sound
inspection practices. Observations should be the verifiable
result of first-hand knowledge. Case proceedings personnel must
be able to depend on the accuracy of all information.
• Relevant. Information in an inspection report should be per-
tinent to the subject of the report. Irrelevant facts and
data will clutter a report and may reduce its clarity and use-
fulness.
• Comprehensive. The subject of the report (i.e., suspected
violation(s) should be substantiated by as much factual, relevant
information as is feasible. The more comprehensive the evidence,
the better and easier the prosecution task.
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• Coordinated. All information pertinent to the subject should
be organized into a complete package. Documentary support
(photographs, statements, sample documentation, etc.) accompanying
the report should be clearly referenced so that anyone reading
the report will get a complete, clear overview of the subject.
• Objective. Information should be objective and factual;
the report should not draw conclusions.
• Clear. The information in the report should be presented in a
clear, well-organized manner.
• Neat and Legible. Adequate time should be taken to allow the
preparation of a neat, legible report.
Confidentiality Considerations and Procedures
All documents and other materials that have been claimed confidential
business information are stored with the Document Control Officer as pre-
scribed in the TSCA-CBI Security Manual. The inspector may review these
documents when preparing the inspection report, but they must be handled
under the strict security measures imposed for TSCA Confidential Business
Information.
Preparation of Inspection Report
In preparing the inspection report, it is recommended that confidential
business information be referenced in a non-confidential manner (i.e.,
by Document Control Number and a general description of the information
contained in the document). An alternative would be to include the
information, but to treat the entire inspection report as a confidential
document. If the latter alternative is selected, the report would be
logged in with the Document Control Officer, ensuring that only persons
cleared for access are permitted to review it.
Field Notes
The procedures for taking field notes (see Chapter Three, Section 4d)
require that potentially confidential information be referenced only in
the field notes, and that the information itself be placed on separate
sheets of paper. The purpose of these procedures was to reduce con-
fidentiality problems associated with the field notebook.
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Chapter Four
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In the event that confidential business information does appear in the
field notes, those pages should be photocopied and the photocopied pages
logged in with the Document Control Officer. The confidential business
information in the notebook should then be obliterated in such a manner
as to make them unreadable.
To ensure that the photocopies of the obliterated pages can be used in an
enforcement proceeding, they must be carefully identified in the following
manner:
• The inspector and a witness should initial and date a spot on
the page that will not need to be obliterated.
• A photocopy of the notebook page should be made. This photo-
copy should be logged in by the Document Control Officer along
with a statement by the inspector which reads:
"The undersigned certifies that this is a true copy of a
page from my field notebook from the inspection of (facility,
address) on (date). The original notebook pages were
obliterated by me to protect confidential business infor-
mation. "
• Confidential business information on the notebook pages should
be obliterated; the identifying initials and date should remain.
Elements of a Report
Although each substance and rule will differ in specific information
requirements for an inspection report, most reports will contain the
same basic elements:
• Inspection Report Forms
• Narrative Report
• Documentary Support
Inspection Report Forms
Individual inspection report forms, developed for most substances
and rules, are designed to collect standard, reviewable information
Inspector's Signature
Witness Signature
Date
Date
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Chapter Four
1 Report Preparation
about an inspection. They function as guides to ensure that all basic
data is being collected, and are generally completed as the inspection
progresses.
Inspection report forms are only one aspect of a complete report and
should by no means be considered to be sufficient in themselves.
Individual items on these forms will often need clarification and
elaboration; inspectors should use the field notebook for this
information.
In cases where inspection report forms are either unavailable or in-
appropriate, pertinent information should be entered in the field
notebook.
Narrative Report
The narrative portion of an inspection report should be a concise, factual
summary of observations and activities, organized in a logical, legible
manner, and supported by specific references to accompanying evidence
(documentary support).
A work plan will simplify preparation and will help ensure that information
is organized in a useable form. Basic steps involved in writing the
narrative report include:
• Reviewing the information
• Organizing the material
• Referencing accompanying material
• Writing the narrative
Reviewing the Information. The first step in preparing the narrative is to
collect all information gathered during the inspection. The inspector's
field notebook should be reviewed in detail. All evidence should be
reviewed for relevancy and completeness. Gaps may need to be filled by
a phone call or, in unusual circumstances, a follow-up visit.
Organizing the Material. Organization of the information can take many
forms, depending on the case, but should present the material in a
logical, comprehensive manner. The narrative should be organized so
that it will be understood easily by the reader.
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Referencing Accompanying Material. All documentary support that
accompanies a narrative report should be clearly referenced so that
the reader will be able to locate these documents easily. The
Documentary Support section in Chapter Three provides details on document
identification. All documentary support should be checked for clarity
prior to writing the report.
Writing the Narrative Report. Once the material has been reviewed,
organized, and referenced, the narrative can be written. The purpose of
the narrative report is to record factually the procedures used in, and
findings resulting from, the evidence-gathering process. In this report,
the inspector should refer to routine procedures and practices used during
the inspection, but should describe in detail facts relating to potential
violations and discrepancies. The field notebook is a guide for preparing
the narrative report.
If the inspector has followed the steps presented in this manual, the
report can develop logically from the organizational framework of the
inspection. In preparing the narrative, simplicity should be a prime
consideration:
• Use a simple writing style; avoid stilted language.
• Use an active, rather than passive approach: (e.g., "He
said that... rather than "It was said that...")
• Keep paragraphs brief and to the point.
• Avoid repetition.
• Proofread the narrative carefully.
A basic format which can be adapted for most narrative reports is out-
lined below.
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Chapter Four
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Narrative Report Format
Introduction
General Information
• State the purpose of the inspection and how the facility came to
be inspected (i.e., neutral scheme, follow-up, for cause).
• State the facts of the inspection (i.e., date, time, location,
name of the agent-in-charge, etc.).
Summary of Findings
• Give a brief, factual summary of the inspection findings.
History of Facility
• List the status of the facility (i.e., corporation, proprietor-
ship, partnership, state agency, non-profit organization, etc.,
and where incorporated).
• Give the size of the organization based on inspector observations
or agency records.
• List any related firms, subsidiaries, branches, etc.
• List the type of operations performed at the facility under
inspection.
• List names and titles of facility officials interviewed. List
the name(s) of officials(s) responsible for day-to-day operations
at the facility.
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Inspection Activities
Entry/Opening Conference
• Describe the procedures used at arrival, including presenta-
tion of credentials and written Notice of Inspection, and to
whom they were presented.
• Describe any special problems or observations if there was
reluctance on the part of facility officials to give consent,
or if consent was withdrawn or denied.
• If special procedures were necessary, such as obtaining a
warrant, describe the procedures.
• Summarize the topics discussed during the opening conference.
• Note presentation of the TSCA Inspection Confidentiality
Notice and the official to whom it was presented.
• Note if duplicate samples were requested.
The remainder of the report should be prepared in the same order
that the inspection was conducted. Be certain to insert all ob-
servations when appropriate and to cover the following topics
when appropriate.
Records
• List the types of records reviewed, noting the reasons for their
review, and referencing documents that were borrowed or copied.
• Describe any inadequacies in recordkeeping procedures, or if
any required information was unavailable or incomplete.
• Note if recordkeeping requirements are being met.
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Documents
• Note and reference any statements taken during the inspection.
• Describe and reference photographs taken during the inspection
if they are relevant to possible discrepancies.
• Reference any drawings, maps, charts, or other documents made
or taken during the inspection.
Physical Samples
• Describe the purpose for which samples were obtained.
• Describe sampling techniques used.
• Reference controlled identification procedures.
• Describe the physical aspects of the sample (color, texture,
viscosity, etc.).
• Describe chain of custody procedures used in sample handling.
Closing Conference
• Note and reference receipts for samples and documents given
to facility officials.
• Note procedures taken to confirm claims of confidentiality
and Receipts for Confidential Business Information.
• Note any recommendations, referrals, etc., made to facility
officials.
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Chapter Four
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Attachments
List of Attachments
• Prepare a list of all documentary support attached to the
report. A general index list, rather than detailed descriptions
will aid case proceedings personnel in locating specific
documents.
Documents
• Attach copies of all documentary support collected during the
inspection. All documents should be clearly identified.
• In cases where documentary support items can not be included
easily with the report, it may be possible to substitute
descriptive information. Consult supervisory personnel about
this.
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Chapter Four
2
Appearing
as a Witness
Vigorous enforcement programs will increase the probability that an
inspector will be called on to testify in court. By the time a case has
entered the judicial system, inspectors and case proceedings personnel
will have invested many hours in developing a sound program for prosecution.
When an inspector is called to testify, it is imperative that quality
testimony is provided and a professional image is projected in the court-
room.
A witness, to be effective, must make statements that are understandable,
and must have them accepted as truth by the judge or jury. In addition
to being truthful and honest, a witness' principal aim should be to make
a favorable impression on the court. The guidelines presented in this
section will help prepare the inspector to be an effective and credible
witness.
Personal Appearance and Conduct
• Dress is important. A well-groomed, neatly attired witness makes
a more favorable impression in the courtroom.
• Conduct should reflect the solemn nature of the judicial proceedings.
• Do nothing that may attract attention to you. Make yourself
as inconspicuous as possible.
• Do not sit in groups with more than 2 or 3 colleagues. Spread
out in the courtroom.
• Do not whisper or talk to another person, or cause any dis-
turbance in courtroom.
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• Show no incredulity or surprise at any testimony given from
the witness stand or at statements made by the defense attorney.
Avoid expressing approval or disapproval of any testimony by
nod, glance, or other gesture.
• Do not have anything in your mouth, including gum, toothpick,
tobacco, candy, or food.
• Do not sit within the enclosure unless instructed to do so.
• Do not discuss the case with the defendant or his attorney.
• Do not talk to the jurors or discuss the case within their hearing.
• Unless directed to do so, do not attempt to consult with case personnel
while court is in session.
• Avoid conversations with principals or witnesses for the opposing
side. If conversation are unavoidable, confine remarks to matters
other than the trial.
• Come into the courtroom prepared. Be thoroughly familiar with your
facts. Pertinent time and dates should be checked. Order all docu-
ments and exhibits so that testimony will be presented without
fumbling.
• Be on time when court opens and be available immediately when called
to testify.
Witness Stand Technique
• When called to the witness stand, unless previously sworn, go directly
to the desk of the clerk of the court to be sworn.
• Take the oath in a solemn manner. Then proceed to the witness chair.
If you have a long or difficult name, give a card or paper with the
correct spelling to the court stenographer.
• Assume and maintain proper posture, bearing, and demeanor. Sit
erect, but don't appear stiff or tense. Attempt to project an
image of poise and self-control.
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Speaking
• Speak in a clear, distinct, and well-modulated voice. When addressing
a jury, look at and speak distinctly to them. Speak plainly enough
so that the farthest juror can hear you.
• Use simple language. If the subject is technical or scientific, re-
duce the terminology to an understandable level or give definitions
of terms used. Avoid idioms or language particular to your pro-
fession or to the Agency.
Notes
• You may bring notes to the witness stand with you. However, do not
bring your field notebook or any other documents you do not want the
opposing side to examine. They have a right to see them.
• Do not hesitate to ask permission to refer to your notes when
testifying, provided your notes were made at the time of, or
immediately after, the event about which you are testifying.
• Do not be embarrassed if you can not recall exact details without
referring to your notes.
/
• Do not read long passages verbatim from your notes.
Answering Questions
• Wait until a question is asked in its entirety before beginning to
answer.
• Never attempt to answer a question you do not fully understand.
• Ask that the question be repeated or rephrased if its meaning
is not clear.
• If you do not know the answer to a question, say so. Don't try
to cover up a lack of knowledge of a particular subject.
• Answer each question with spoken words. Don't nod assent or shake
your head.
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• Don't volunteer information. Answer only the question asked, but
answer it fully and to the point.
• Don't spar with the questioning attorney or attempt to match wits
with him. Answer all questions frankly, factually, and confidently.
• Be truthful. Remember that you are sworn to tell the truth.
• Be factual. Limit your testimony to those facts about which you
have first-hand knowledge. Anything else may be hearsay.
• Don't express opinions or conclusions unless you are testifying
as an expert witness. State only facts.
• Don't assume expert knowledge in a field unless you are an expert
by reason of your training and experience.
• If questioned on a subject beyond your soope, admit that the
subject is outside your field or knowledge.
• Don't exaggerate. State the facts accurately, don't embellish
them.
General Guidelines
• Don't be afraid to admit that you discussed your testimony with
Government attorneys. There is nothing improper in a practical
discussion of your testimony with the attorneys.
• In your effort to appear impartial and unbiased, do not become listless
or "dead pan." Be natural, candid, frank, and "alive."
• Do not appear impatient or overly anxious to testify.
• Do not speak to the judge unless he asks you a question.
• Attempt to minimizfe nervous tendencies, such as arranging clothes,
notes, etc.
TSCA Inspection Manual
Volume One
4-14
January, 1980
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Chapter Four
2 Appearing as a Witness
Testifying under Cross-Examination
Cross examination is the questioning of witnesses by attorneys representing
the opposing side. Under cross examination you may be subjected to
vigorous questioning.
• The opposing counsel may attempt to intimidate you by attacking
your veracity and integrity, by making uncomplimentary references
to your qualifications or length of service, or by empahsizing
errors you have made. Remain calm and answer any question asked
unless an objection is raised and sustained.
• If the cross-examiner attempts to confuse you with rapid questions,
answer him deliberately and at a comfortable pace. Ask him to
repeat or rephrase any question that is unclear or confusing.
• If asked a double or "two-pronged" question, ask the cross-
examiner to restate it, or carefully answer each part separately.
• Wait several seconds before you answer a question put to you in
cross examination in order to give the U.S. Attorney an opportunity
to object. Avoid, however, undue delays in answering.
• If an objection has been raised, do not answer any questions
until a ruling on the objection has been made.
• Don't lose your patience or temper while testifying. A cross-
examining attorney often deliberately baits an irascible witness
to anger him. Remain calm and unruffled.
• Do not become argumentative with the cross-examiner if he interrupts
your testimony or for any other reason.
• Beware of questions to which the cross-examiner demands a "Yes" or
"No" answer if such an answer will not reveal the entire truth.
These are often leading questions. If a simple yes or no
does not properly answer the question, inform the cross-examiner
that the question can not be so answered.
• If the cross examiner should misquote any of your earlier testimony,
you may correct the misquote before answering the question.
• If you make an error while testifying, correct it at the first
opportunity. If you discover the error after you have completed
your testimony and have been dismissed, discuss the matter with
the U.S. Attorney.
TSCA Inspection Manual
Volume One
4-15
January. 1980
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Chapter Four
2 Appearing as a Witness
• You may be asked whether you regard certain persons in the field
about which you are testifying as recognized authorities. This is
often preparatory to asking you whether you agree with certain
statements which those authorities made in writings, etc. If your
answer is no, that you don't recognize them as authorities, that
line of cross-examination cannot be pursued. Unless you definitely
have heard of the named persons and are familiar with their works
and do recognize them as authorities, don't expose yourself by
saying that you so recognize them.
Proper Conduct During Recess and After the Trial
• During recess, continue to maintain the same demeanor as in the
courtroom.
• Don't engage in loud conversation or joking, especially about the
proceedings.
• Be as discreet as possible when making any comments that might
be overheard.
• After the trial, continue to conduct yourself in a manner that will
bring credit to you and to the Agency.
• Make no public display of elation or disappointment over the
outcome of the trial.
• If there is occasion to speak to the defendants, be courteous
regardless of their demeanor.
TSCA Inspection Manual
Volume One
4-16
January. 1980
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CJ!
C/3
"O
a.
Q)
Ct>
a.
c
¦n
-------
Chapter Five
Special Procedures
Chapter Contents Page
Subpoenas
Introduction 5-1
Role of the Inspector 5-1
2 Seizures
(This section is reserved for future development)
TSCA Inspection Manual
Volume One
January. 1980
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TSCA Inspection Manual
Volume One
January. 1980
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Chapter Five
1
Subpoenas
In the general sense, a subpoena is an order to a witness to appear
at a specified time and place to give testimony before a court or a
magistrate. In a civil context, a subpoena is used to require a
person to deliver documents in his possession to a court or authorized
agency. Such documents will be pertinent to a particular inspection
or investigation.
Section 11(c) of TSCA authorizes the EPA Administrator to require,
by subpoena:
• The attendance and testimony of witnesses; and
• The production of reports, papers, documents, answers to
questions, and other information that is deemed necessary
by the Administrator.
The TSCA subpoena is enforceable by United States District Court.
Failure to respond to the subpoena carries contempt of court penalties.
The Inspector's Role in the Subpoena Process
The effectiveness of a subpoena lies in part in its flexibility. It's
purpose and content will depend upon the matter under investigation,
as will the method used to serve the subpoena.
Specific procedures regarding the role of the inspector have not been
developed. Instructions and directions for inspector involvement
will come from enforcement supervisors.
TSCA Inspection Manual
Volume One
5-1
January, 1980
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Chapter Five
1 Subpoenas
Reference to subpoena authority or to contempt penalties should never
be made during an inspection. Any difficulties relating to the
collection of information during an inspection should be referred
to a supervisor immediately. Case proceedings personnel will evaluate
the situation and determine a suitable response.
Should an inspector be called upon to serve a subpoena, detailed
instructions will be provided by the appropriate case proceedings
personnel.
TSCA Inspection Manual
Volume One
5-2
January, 1980
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o>
3
(A
-------
Chapter Six
Forms
Chapter Contents Page
Instructions and comments are located on the pages
facing each of the forms listed below.
Notice of Inspection 6-1
TSCA Inspection Confidentiality Notice 6-3
Declaration of Confidential Business Information 6-5
Receipt for Samples and Documents 6-7
Chain of Custody Record 6-9
TSCA Inspection Manual
Volume One
January, 1980
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Chapter Six Forms
Notice of Inspection
1. Enter Inspector's
name and EPA office
address.
2. Sign the Notice of
Inspection.
3. Enter the Inspector's
official title.
4. Enter the complete,
official name of the
firm to be inspected.
5. Enter the complete
street address of the
firm to be inspected.
6. Enter the date of
inspection.
7. Enter the time of
entry.
8. Enter the name and
title of the person
receiving the Notice
of Inspection.
9. Have the recipient
sign the Notice of
Inspection.
ocPA E.?/r
I Kjnce 0f= Inspection
I1
8
at ferlplai
kLASON >0H IHSPLCT10N
UnJtr tliu authority of Soction 11 of tho Toxic SubBtaiicou Control Act
n fur th«. purpoaa of in&pcctiny (Including taking fracnpluH, phctogrfiphn,
ul otliur inspection activities) ajtdl»l i slirrw.nt facility.
10
~
prt.ni bus tn vli
. CllCftilCnl bUUbL^HCUb Ol ¦nlMlUIL'* Of AllLC.li.il
die Mmifui.tun.if, J oi stored o* htJd J-u.ro.ri.
i d i a 1.11 b«iL U>n hi (inc Lu J i no r*.corila ftlu
tatb, cun 11 u I», oik) 'abilities) nul «niy coiw< yeuc. u iicliiLj
0 tcadsfoit Chemical «.» Ot dflicRt cantdinjny
n toiiiiniiui wit.li tliLir vliution i'i «.orruiHJii> ( mi lu<( 1119 molds
I'roc. Li.iaiol. a»u1 lnvlluki) U Ut'inn,1. villi diiL.il pmniaib 01 ciiiwiyanii Iwvu
In addition, 1Mb mbpuction extend* Co icirclo aviJ[0|ji lAtu lotturc)
(A) Financial dutd
(H) Sale* ddta
((.) Puc. luy (I.iCd
(U) Putuomtol data
(El Kg .it r 4>Cl 1 data
The future and extent. of inspection of such dotfl bpOClflod in A through
E dUjvu ad tollowb
II
10. Check the appropriate
boxes concerning the
scope of the inspection.
11. If the inspection will
include any data listed
in items A through
E on the form, specify
the nature and extent
of inspection of this
data.
TSCA Inspection Manual
Volume One
January, 1980
-------
Name of Firm
United States
Environmental Protection
Agency
Firm Address
Notice of Inspection
Inspector Name and Address
Date
Time
Inspector's Signature
Name and Title of Recipient
Signature of Recipient
~
~
REASON FOR INSPECTION
Under the authority of Section 11 of the Toxic Substances Control Act
For the purpose of inspecting (including taking samples, photographs,
statements, and other inspection activities) an establishment, facility,
or other premises in which chemical substances or mixtures or articles
containing same are manufactured, processed or stored, or held before
or after their distribution in commerce (including records, files,
papers, processes, controls, and facilities) and any conveyance beinq
used to transport chemical substances, mixtures, or articles containing
same in connection with their distribution in commerce (including records,
files, papers, processes, controls and facilities) bearing on whether the
requirements of the Act applicable to the chemical substances, mixtures,
or articles within or associated with such premises or conveyance have
been compiled with.
In addition, this inspection extends to (circle appropriate letters):
The nature and extent of inspection of such data specified an A through
E above as follows:
(A) Financial data
(B) Sales data
(C) Pricing data
(D) Personnel data
(E) Reserach data
-------
Chapter Six
Forms
TSCA Inspection Confidentiality Notice
1. Enter Inspector's named)
and EPA office address(2)
2. Enter the complete,
official name of the
facility being inspected
(3) and its complete
street address (4).
5. Enter the name (5), title
(6), and complete
address (7) of the chief
executive officer of the
firm.
8. Enter the
title (9)
receiving
10. Enter the
Notice.
name (8) and
of the person
the Notice.
date of the
11. Enter the complete
address of the Regional
Document Control Officer
authorized to receive the
statement from the chief
executive officer.
12. Enter the name (12) and
title (13) of the person
receiving the Notice. Have
this person sign (14) and
date (15) the Notice.
prtA UwdSuiw
Ert»»/o/LI A Agmv
3
TSCA Inspection
Confidentiality Notice
4
" I
1/afactaa
2
Oiltl bmtii. tfficaa al rui h
D
nib
6
MlM
7
¦ua *1 l» *ra >dlci g
9 10
11 I* M»ll ¦ t>a\ 01 Mil p.»llc iqwiu > ISt la « piUUll • ••Utkla .laa-
far ulaaM mt tM lulxruiioai rtoairari ŁufL-<| t*-
tfrittm (Mini) Dm Iwl fafwaaia vtU
U >ir4lrf r»* La >11)1 [/niilM at » of In'erMtlwi wH c*>h •«*-
tSa rf**4w •( IrTar-attC* VI ITOJ) 1 0 1 C JSJl ataMUl t» foul • rtr^uu»a
D» r*f«]alJara Iiim4 INOkhd «• 71 Put li aari Mlllla
C** full b*u*l kl lactic* It n U
ra?..liad 1* rala Ir.^t ea taia ~all.il. U ia- »t Usa «.* . 1 cm af if* In rai -ill ha
fela*^a""ln'' »«¦» .r. nl Dt t*i T*»> t»f«| *» «a»a
t* u>«* or i-T*s.tfii al if tlaL-a iMi a«-iica »ll| U nit bf
j'ai jm a.(IIu la ta coar'Jtmlal t )o» w*la t.MlllH -"ail > cbi *tU xim m.lft (at tfataaala
« >1*4 el wIKiki fcalltr U* »jJ] *!*l«aa tt-» L*- M-; •• .iSj miiikI* u is. (Mil bwvtlr.
oru<)«» orIt «a Uaa eaiaa* ui< by to.na at MIU%t wt ffj n ••it- * ^ *
liM^nrn i.l r«tb U aafaUtlam IcllaA ttanal "*•« Sti*t &*fl »a MMtti nu» • ulmK
(*•((¦> Di » UtiUM «l tlafk'ijil'tl lilWMlka (,*aflat«>a4 i.tiua ractl^ ra^iarlai
1 INI Rr^lf '41 LUii WIWT«| ta FTOTant lla aaJI nuila »*.«a l»l c«U-»l*j «»,• a* i.aatf* arf
cKxtliranallcr al LSa lnfarM(l«a ar* It I*- il« MU«
¦ inta l* natlnta it U>a ucl taiMa*
r»l «jr bf pa fix* w tuijalt • >tliiaa aaiyaart
afclr r*-u lUlta vtLSOM jw n^i[ • rmuM a< tba tuv «Jca af iSa lii^ctlaa aa ^ t>a Oilaf
t7 a tar paraona (nNai ik<* (ramiMa) bc4laal ttardln Ptftcal >iUilt v-*a mat-lii («ilcd *ttl
tr vm at nlllama aaaaa lallat lliaaaT ta witlri »J »l aa I .»'»ar by i«u cupaaj *4
i*,r4 w. a atewlrt af ip«&i nnTKarti.licj tra L*-
ti -Jti yitlil (rrovi'r^l •?*< '<¦> «va
> 'a n 'ifii.t? a1 IrlU r«cal< m *a(lca
1 T.4't mil ••Ł a-rf a aa4 XI a «at|«.
la ksnli«aa ctn. ISarnlality tlalaa (a* Ja rira a rtvj Ula
btji* * «<•!«• uiarliii ta arat i* (h. pa(4my »
C\i»l Ciacji ». Sfiiaa I' i an it uai'u 11x^17 •ttlrla) <*•
¦>«« 1 i!i« mil a 1 (1 if«n«la« If 11a ^ln
12
"" 16
13
17
14
JAli.aa
18
15
16. Enter the name (16),
title (17), and complete
address (18) of the
company official who, in
addition to the chief
executive officer, should
receive a copy of the
Notice.
TSCA Inspection Manual g_2 January. 1980
Volume One
-------
JV United States
Environmental Protection
m \ Agency
TSCA Inspection
Confidentiality Notice
Facility
Facility Address
Inspector Naine
Chief Executive Officer of Firm
inspector Address
Title
Name of Individual to whom Notice Given
Title
It is possible that EPA will receive public requests 3 The information is not publicly available else-
for release of the in.formation obtained during in- where
soection of tMe facility above Such requests will
be handled by EPA in accordance with provisions of 4 Disclosure of the information would cause sub-
the freedom oŁ Information Act (FOIA), 5 U S C 552, stantial harm to your company's competitive
EPA regulations issued thereunder, 40 CFR Part 2, and position
the Toxic Substances Control Act, Section 14 EPA is , w .
. , _ - At the completion of the inspection, you will be
required to make inspection data available in re- r ^ 1
, ^ _ DrtT, „ i fci_ ^ « given a receipt for all documents, samples, and other
sponse to FOIA reuuests unless the Administrator of , ,
f.y.. ._ - materials collected At th«t time, you may make
the Agency determines that the data contains informa- , , , » „
. , „ _ . . _ j ~ claims that some or -all of the information is con-
tion entitled to confidential treatment
fidential and meets the tour criteria listed above
Any or all the information collected by SPA during the
msoection may be claimed confidential if it relates K you are ^thorized by your company to nake
to trade secrets or comr-erciai or financial matters confidentiality claims, this notice win be sent by
that you consider to be confident^ If you make certified mail, along with the receipc Cor documents,
, cl
-------
Chapter Six
Forms
Declaration of Confidential Business Information
1. Enter the complete EPA
Regional Office address.
2. Enter the date of this
declaration.
3. Enter the name(3), title
(4), official firm name
(5), and complete firm
address (6) of the
individual making this
declaration.
7. List by title or descrip-
tion all information
begin designated as
confidential business
information.
8. Have the individual
making the declaration
sign (8) and list his/
her title (9).
10. Enter the name and title
of the Inspector
11. Sign the Declaration
(Inspector).
SERA
¦Jrurtd S:ite»
IftWOAfflClU*! PrOUCOQA
Declaration of Confidential
Business Information
Inforucion Designated is Confidential Suslneis fnfcrajcion
Hcltr.ovladq*J4re by Claimant
Ttie undersigned ackno«lad?ei tfeat the Information d«scrit«d ibcve it designated *s Confidential
Business Information under Section 14(e) of tfe to*ic 3uhst&nce« Control Kcx. The undersigned
furtfur eCAnovled-jea Cut he/she l« authorized to u«( »uc1 cluu far his/her firs
TJw undersigned also certifies Uut each itai described iSove eaeti All of t-l« following criteria
<1) The ooep*ny h«e tajten aeaeurei to protaet the cant Ld»-ti*l Ity of Cie information and it
intends to oontliue to take auch Msiiire*. (2} Tti« infor-ution is not, and has net been reasonably
attainable vittout the company's oonsent by other peracri (other Uian governmental bodies] Sy use
of muu (at>«r than di«cov«ry basad on * aSc^ -g of spee'al need in a judicial or
quasi-Judicial proceeding) i (1) The information is *>ot pu^l.cly ava.labia else^are **vd
(4] Disclosure of the information would causa suflstartial. Sara to the company a competitive
position
Dvar H
-------
&EPA
United States
Environmental Protection
Agency
Declaration of Confidential
Business Information
EPA Regional Office Address
Name of Individual
Title
Firm Name
Firm Address
Information Designated as Confidential Business Information
Acknowledgment by Claimant
The undersigned acknowledges that the information described above is designated as
Confidential Business Information under Section 14 (c) of the Toxic Substances Control
Act. The undersigned further acknowledges that he/she is authorized to make such
claims for his/her firm.
The undersigned also certifies that each item described above meets all of the
following criteria: (1) The company has taken measures to protect the confidentiality
of the information and it intends to continue to take such measures; (2) The infor-
mation is not, and has not been reasonably attainable without the company's consent
by other persons (other than governmental bodies) by use of legitimate means (other
than discovery based on a showing of special need in a judicial or quasi-judicial
proceeding); (3) The information is not publicly available elsewhere; and (4)
Disclosure of the information would cause substantial harm to the company's
competitive position.
Signature (Owner, Operator, Agent)
Name of Inspector
Inspector's Signature
-------
Chapter Six
Forms
Receipt for Samples and Documents
1. Enter Inspector's name
(1) and EPA office
address (2).
3. Enter name (3) and
complete address (4)
of the firm being
inspected.
5. Enter the name (5)
and title (6) of the
individual receiving
this Receipt.
7. Enter the date of
collection of the
samples and docu-
ments listed on the
Receipt.
8. Check the appropriate
column if duplicate
samples were requested
and received.
9. List the sample numbers
of all samples taken.
10. List by title or
description all
samples and docu-
ments taken during the
inspection.
11. Sign (11) and date (12)
the Receipt.
A pp* UnntdSUlM
tl
*1 rt™
3
Receipt for
Sahpies *nd Documents
4
1
2
Um at
5
niu
6
< • Callacia*
7
.... g
9
T*-« docxaanta *nd u^l*a of cwtnie*i rufettiocta and/or olreutaa daacrib«d b«lov collected
la connection with tin tdalnlrtn'ico ud tnfore«=«at of tha Sub*t*oea» Control tefc
P-actipt for dociaaat(a) tad/ox u=pla(a) Ł«aarlb*d btlov ia tartby *ckjtevl«dged>
10
l.{ ..r.i. «f
II
13
n« >
12
n«u
14
13. Have the facility
official named in (5)
sign (13) the Receipt
and list his/her title
(14).
TSCA Inspection Manual
Volume One
6-6
January, 1980
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&EPA
United States
Environmental Protection
Agency
Receipt for
Samples and Documents
Inspector Name
Name of Firro
Finn Address
Inspector Address
Name of Individual
Date Collected
Duplicate Samples Requested and Received
( ) Yes ( ) No
Sample Numbers
The documents and samples of chemicalsubstances and/or mixtures described below were
collected in connection with the administration and enforcement of the Toxic Substances
Control Act.
Receipt for the document(s) and/or sample(s) described is hereby acknowedged:
Signature of Inspector
Title
Signature of Owner, Operator, or Agent
Title
-------
Chapter Six
Forms
Chain of Custody Record
1. Enter Inspector's name
and EPA office address.
2. Sign the Chain of
Custody Record.
3-4. Sample and Inspection
numbering program is
currently under develop-
ment. Information
regarding these spaces
will be provided at a
later date.
5. Task numbers refer to EPA
contractors. Inspectors
may disregard.
6. Describe the sample,
including size, container,
and contents. (e.g. 8 oz.
bottle of PCB transformer
oil.) List brand names
if any.
7-8. List date (7) and time
(8) sample was collected.
9. Indicate if duplicate
sample was requested by
facility officials.
/\ pn* Un.WdSum
Environmtnui ftoitctton
>SL.I fl Agancy
Cham of Custody Record
lUft* KhAbal
3
Till •»»¦Ł• I
5
1
1
i Latpactor mm 4/td uImii
I
6
04?I| Tw< OuplKiii liifitiol
7 8 -9
Utpaetac _
2
LMlllO* Of
10
II
UtftDrtiorr
OA I ¦
ftacaivad ay
l«lt Vu
tMpla ttniuiflB
Cw4illM af SmIi
Uftlta iKIk'd
IUI ¦ UcttlMI
iMIfMl If
tlllfKM TD
Dali»aia4
Data Dali*ara«
MMI at Uaita
uwn »r
lurtl* bMIIM
Data MmUi af Mwlyili
liaiid u oi
Data laawlti af toialjaia
in.«j «• r*«iiiir
10. Enter name and address
of firm.
11. List testing required for
samples collected. (e.g.
test for PCB concentration.
The remaining parts of the
Record will be completed by
personnel other than the
inspector.
TSCA Inspection Manual
Volume One
6-8
January, 1980
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4^ United States
Environmental Protection
^#L_I r\ Agency
Chain of Custody Record
Sample Number
Task Nur.bcr
Inspection Number
Sample Name
Inspector Name and Address
Date Sample
Time
Duplicate Requested
( ) Yes ( ) No
Inspector Signature
Location of Sampling
Analysis/Testing Required
Laboratory
Date Received
Received By
Sent Via
Sample Condition
Condition of Seals
Units Received
Storage Location
Assigned By
Assigned To
Delivered By
Dace Delivered
Nuhber oC Units Received
Units Analyzed
Date Seal 3roken
Date Resealed
Resealed By
Storage Location
Date Results of Analysis
Issued to EPA
Date Results of Analysis
Issued to Facility
Remarks
-------
TSCA Inspection Manual
Volume One
January. 1980
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CU
a?
cn
<
a
<0
3
i/i
-------
Chapter Seven
Data Systems
This chapter is reserved for future development.
TSCA Inspection Manual
Volume One
January. 1980
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TSCA Inspection Manual
Volume One
January. 1980
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Appendix A
Shipping Samples
This Appendix outlines considerations for preparing samples for shipment
to a laboratory for analysis.
When it is not feasible to personally deliver a sample to the examining
laboratory, it should be shipped by the most economical means com-
mensurate with the need for rapid handling. Sample documentation
should be forwarded under separate cover.
Shipping Hazardous Substances
Shipments of hazardous or toxic substances via postal service or common
carrier are subject to regulations developed by the Department of
Transportation (DOT) and the U.S. Postal Service (USPS). These sub-
stances are generally classified into three independent hazard
categories:
• Toxicity
• Flammability
• Corrosiveness
Specific definitions and requirements can be found in USPS Publication
52 and in the Department of Transportation Hazardous Materials Regulation,
Title 49, Code of Federal Regulations, Sections 170-179 (49 CFR 170-
179). The sources should be consulted for guidance when preparing
samples for shipment.
DOT and USPS do not list specific shipping requirements for chemical
substances currently regulated under TSCA jurisdiction. However,
samples taken during an inspection will often contain other substances
TSCA Inspection Manual
Volume One
A-l
January, 1980
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Appendix
A Shipping Samples
that may be subject to DOT regulations. For example, a PCB sample may
be partly composed of a solvent that is highly flammable. The total
composition of the sample should be taken into account for shipping
purposes.
It is the responsibility of the inspector to observe shipping regulations
to ensure safe and efficient shipping of samples.
Packing Samples for Shipment
Security Considerations
All samples must be securely packaged in a manner that prevents mixing
of the substances within the package or their release into the
environment.
• Fragile Containers
Fragile containers should be packed in cushioning material to
prevent shifting and breaking while in transit.
• Liquids
Liquid samples should be packed in sufficient cushioning or
absorbent material to absorb and retain any leakage which
might occur.
Liquid and dry samples should not be packed in the same shipping
case as leakage might contaminate all samples.
Containers of liquid samples should have effective closure
mechanisms: screw caps, soldering, clips, or other means to
prevent leakage. Friction closures (i.e., lids of the type
found on paint cans) are not generally acceptable for transit
unless an additional method of security is provided.
• Aerosols
Aerosol containers are accepted for shipment by both parcel
post and common carriers if packaged in accordance with
DOT regulations concerning the limit of quantities of com-
pressed gases (49 CFR §173.306).
TSCA Inspection Manual
Volume One
January. 1980
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Appendix
A Shipping Samples
Aerosol containers must have a positive means to prevent
accidental discharge of contents. This may be accomplished
through the use of recessed valves, screw thread caps, tape
closures, or other effective means of preventing discharge.
Markings
Packages containing samples of toxic or hazardous substances must be
properly and clearly marked. The following information should be
included:
• Name and address of both shipper and addressee.
• "Shipping name" of the article (i.e., the generic name as
listed at 49 CFR 172.101)
• Hazardous materials warning label(s), if appropriate (e.g.,
"Flammable", "Poison", etc.) Aerosol containers when shipped
by air must bear the label "Compressed Gases".
• Handling cautions: "Glass", "Handle with Care", "This End
Up", etc., as appropriate.
Parcel Post Shipment
Shipment of Samples
Samples within parcel post size and weight limits should be shipped
by this means.
Gallon-size glass bottles should not be shipped by parcel post.
Payment of Charges
Parcel post is mailed under the Government frank on the address label
reading: "Postage and Feed Paid" and showing a Government department
as shipped, over words: "Official Business". EPA Form 1820 - Mailing
Label should be used for this purpose.
Postal Regulations
USPS Publication 52 and the USPS Domestic Mail Manual should be used
as a guide when making shipments by mail.
TSCA Inspection Manual
Volume One
A-3
January, 1980
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Appendix
A Shipping Samples
Government Bill of Lading
The U.S. Government Bill of Lading (GBL) is the primary document used
to request freight and express transportation and related services
from commercial carriers. It is used for transportation of property
when freight charges are to be paid by the Government directly to
commercial carriers regardless of the mode of transportation or the
amount of transportation charges.
A GBL should be prepared for all shipments made by common carrier.
Small shipments, however may move on commercial bills of lading as
authorized by the General Accounting Office (5 GAO 3). Refer to the
GSA publication "How to Prepare and Process U.S. Government Bills of
Lading (7610-00-682-6740) for specific details.
General Guidelines Concerning Mailability
• Substances that may kill or injure, or damage mail or other
property are considered non-mailable unless specifically
provided for in the postal regulations or guidelines.
• All parcels containing hazardous materials must have the
nature of the contents stated clearly on the outside of
the package.
• The mailer is ultimately responsible for determining before-
hand whether an item is mailable or not. Inspectors should
keep abreast of current regulations concerning shipment of
hazardous materials.
Common Carrier Shipment
Motor freight or United Parcel Service should normally be used for
larger shipments and for shipments of more fragile and toxic samples.
• Buses should only be used when another means of transportation
is not available and only for less toxic substances.
• Air freight should be used if rapid handling is imperative.
Certain restrictions apply to the type of substance shipped,
and specific marking and labeling requirements may apply.
TSCA Inspection Manual
Volume One
A-4
January, 1980
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Appendix
A Shipping Samples
DOT Regulations
The Department of Transportation regulates the transportation of all
hazardous materials within the United States, and all shipments made
by common carrier are subject to DOT regulations and requirements.
49 CFR 170-179 provides details of DOT regulations concerning
classification, packaging, marking, labeling, and other shipping
requirements. This source should be consulted to ensure compliance
when shipping samples.
• Certification
The shipping papers must contain the shipper's certification
that the materials are properly classified, described,
packaged, marked, and labeled, and are in proper condition
for transportation in accordance with all applicable govern-
ment regulations.
TSCA Inspection Manual
Volume One
A-5
January. 1980
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TSCA Inspection Manual
Volume One
January, 1980
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X
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Index
Agency Records Review 3-1
Attire
Inspector Responsibility 2-15
Safety 3-47
Chain of Custody
Elements of Custody 3-43
Procedures 3-44
Record 3-4, 3-40
Sample Form 6-9
Citizen Referral Inspection 2-6
Closing Conference 2-4
Confidentiality 3-62
Industry Outreach 3-63
Receipts 3-61
Communications Skills 2-13
Complaint Inspections 2-6
Confidential Business Information (CBI)
Access Authorization 2-3
Authority to Claim CBI 3-17, 3-62
Confidentiality Notice 3-4, 3-16, 6-3
Declaration of CBI 3-62
Document Identification 3-29
Field Notebook 3-32, 4-2
Inspector Responsibility 2-11
Overview 2-3
TSCA Inspection Manual
Volume One
X-l
January. 1980
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Index
Confidential Business Information (CBI) (Continued)
Photographs 3-36
Preparation/Distribution of Forms 3-18
Records Inspection 3-28
Report Preparation 4-2
Safeguards 3-3, 3-67
Samples 3-40, 3-45
Security Measures 3-65
Consent to Inspect 3-8
Reluctance to Admit 3-9
Copying of Records 3-26
Computer or Electronic 3-26
Visual Systems (microfilm, microfiche) 3-27
Written or Printed 3-26
Credentials and Verification 3-8
Uncredentialed Persons 3-9
Custody Seal 3-4, 3-40
Elements 3-40
Custody Sample 3-43
Declaration of Confidential Business Information
Closing Conference 3-62
Pre-mspection Preparation 3-4
Sample Form 6-5
Denial of Entry
Limited Entry 3-10
Marshall v. Barlow's Inc. 3-9
Procedures 3-9
Withdrawal of Consent 3-10
Disclosure of Information
Section 14 TSCA 1-11
Synopsis 1-5
TSCA Inspection Manual X-2 January. 1980
Volume One
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Index
Documentary Support
Objective 3-31
Confidentiality Procedures 3-32
Drawings and Maps 3-36
Documentary Sample 3-37
Duplicate Samples
Opening Conference 3-19
Emergency Equipment
Checklist 3-6
Safety 3-47
Emergency Inspections 2-5
Emergency Telephone Numbers 3-56
Emergency Treatment
Eye Contact 3-53
Ingestion 3-54
Inhalation 3-51
Skin Exposure 3-52
Employee Protection
Section 23 TSCA 1-26
Entry
Arrival 3-7
Authority 3-7
General Procedures 3-8
Equipment, General 3-4
Equipment Preparation 3-4
Checklists 3-5
Ethics 2-14
Evidence Gathering
Sampling and Documentation 3-21
Inspector Responsibility 2-11
Exports and Imports
Sections 12 and 13 TSCA 1-22
Synposis 1-5
TSCA Inspection Manual
Volume One
X-3
January, 1980
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Index
Federal Laws
Section 9 TSCA 1-21
Synposis 1-4
Field Notebook
Administrative Entries 3-31
Confidential Business Information 3-32
Entries 3-33
First Aid
Emergency Treatment 3-50
Forms 6-1
Chain of Custody 6-9
Confidential Business Information 6-5
Confidentiality Notice 6-3
Notice of Inspection 6-1
Receipt for Samples 6-7
Hazardous Chemicals
Section 6 TSCA 1-17
Synopsis 1-4
Health (See Safety)
Imminent Hazards
Section 7 TSCA 1-19
Synopsis 1-4
Industry Assistance 3-15
Industry Relations 2-15, 3-63
Information Requests 2-15
Information Retrieval Systems 3-24
Computer or Electronic 3-26
Visual Systems (microfilm, microfiche) 3-27
Intergovernmental Regulatory Liaison Group (IRLG) 2-6
Inspection Warrant
General Information 3-11
Model
Policy 3-11
TSCA Inspection Manual
Volume One
X-4
January, 1980
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Index
Inspections
Section 11 TSCA 1-11
Authority 2-1
Confidentiality 2-3
Elements 2-4
Purpose 2-2
Scope 2-2
Special Operations 2-5
Synopsis 1-5
Inspector Authority
Confidentiality Clearance 2-8
Credentials 2-7
Field Notebook 3-25
Laws Applicable 2-8
Inspector Responsibility 2-11
Location of Records 3-24
Manufacturing and Processing Notices
Section 5 TSCA 1-14
Synopsis 1-5
Marshall v. Barlow's Inc.
Denial of Entry 3-9
Mechanical Recordings 3-36
Notice of Inspection
Entry 3-8
Preparation 3-4
Sample Form 6-1
Penalties
Section 16 TSCA 1-23
Photographs
Opening Conference 3-19
Documentary Support 3-35
Physical Sample 3-37
TSCA Inspection Manual x-5 January. 1980
Volume One
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Physical Sampling Program
Documentation
Equipment
Handling
Identification
Representative Sample
Sealing the Sample
Pre-Inspection Preparation
Documents
Objectives
Overview
Prohibited Acts
Section 15 TSCA
Synopsis
Protective Clothing
Decontamination
Personal Safety Equipment
Opening Conference
Overview
General Information
Receipt for Samples and Documents
Closing Conference
Pre-inspection Preparation
Sample Form
Recordkeeping and Reporting
Section 8 TSCA
Inspection Requirements
Copying
Identification Procedures
Records Identification Procedures
Confidential Documents
Initialing and Dating
Logging
Numbering
Index
3-42
3-38
3-41
3-39
3-38
3-40
3-3
3-1
2-4
1-23
1-5
3-55
3-47
2-4
3-15
3-61
3-4
6-7
3-20
3-23
3-26
3-27
3-29
3-27
3-27
3-27
TSCA Inspection Manual
Volume One
X-6
January. 1980
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Index
Records Inspection
Confidentiality Considerations 3-28
Procedures and Considerations 3-24
Objectives 3-23
Records, Types 3-24
Report Preparation 4-1
Confidentiality Considerations 4-2
Narrative Report Format 4-6
Reporting and Retention of Information
Section 8 TSCA 1-20
Synopsis 1-4
Research and Development
Section 10 TSCA 1-21
Synopsis 1-4
Respiratory Protective Equipment 3-57
Safety 3-47
Bibliography 3-58
Emergency Treatment 3-50
Equipment 3-47
Equipment Checklist 3-6
Guidelines 3-49
Responsibility 2-13, 3-47
Sampling and Documentation
Authority 3-21
General 3-21
Objectives 3-21
Overview 2-5
Receipts 3-61
Samples
Confidential 3-40, 3-45
General 3-19
Physical 3-37
Sampling Equipment 3-5
Sample Seal 3-40
Sample Handling and Shipping 3-41, A-l
TSCA Inspection Manual
Volume One
X-7
January, 1980
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Index
Security Measures 3-65
Routine 3-65
TSCA-CBI 3-66
Special Procedures
Subpoenas 5-1
Statements
Inspection Objective 3-33
Procedures
Synposis
3-34
Testing
Section 4 TSCA 1-12
1-3
Voluntary Compliance 3-15
Warrants
General 3-11
Model
Policy 3-11
Securing and Serving Warrant 3-12
Witness
Conduct 4-11
Cross-examination 4-15
General 4-11
Technique 4-12
TSCA Inspection Manual x-8 January, 1980
Volume One
GUfl. GOVERNMENT PRINTING OFFICE 1980 311-132/24 1-3
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