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TSCA
SECTIONS 5 & 8
PRAGTIC’E MANUAL
OFFICE OF ENFORCEMENT. ANP cOMPLIANCE MONITORING
TOXICS LITIGATION DIVISION

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N OVERVIEW OF TEE J!OXIC :SUBSII!ANCES CONTROL CT
PUBLIC -LAW 94—469
ENACTED OCTOBER 11, i976
A series o events occurred in the late 1960’s and early 1970’s
which rais’ d a new level of concern in the United States and
particular:..y in the Congress of the United States. As stated
in the opeiing paragraphs of the Toxic Substances Control Act
(TSCA), “Congress finds...human beings and the environment are
each being exposed each year to a larger number of chemical
substances and mixtures.” In creating the law, many
attributes of the Federal Pesticide Act as amended in 1972,
previously known as the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) were used. Before new pesticide
products, or new uses for existing pesticides are allowed to
enter the market place, the products must undergo a very
thorough review to assure that no unreasonable risk or harm
shall come to human health or the environment. This was what
was envisioned when TSCA was created. The short title given
the act by Congress was The Toxic Substances Control Act
(TSCA).
Of the 68,500 plus chemicals and mixtures regulated by the act,
only a relatively small percentage are truly hazardous or toxic
to humans and/or the environment. Less than 500 chemicals are
listed in the Chemical Hazard Emergency Profile, although
slightly over 700 are listed under CERCLA. This is only
slightly over 1.0% of all chemical substances and mixtures
listed on the TSCA inventory. A more proper name for the law
would have been the’ 1 Commercial Chemicals in Comnterc Act.”
The Toxics Program, as it became known, was implemented during
the late 1970’s. It was placed in the Office of the Assistant
Administrator for Pesticides, which then became the Office of
the Assistant Administrator for Pesticides and Toxics
Substances. The Assistant Administrator for Pesticides and
Toxic Substances consists of four offices and 17 divisions
under his/her control for the administration of FIFRA and TSCA;
eight divisions make up the Office of Toxic Substances.
Rather than attempt to explain the activities of each division
and branch in the Office of Toxic Substances, TSCA will be
described according to the activities mandated by each section
of the act. Regional responsibilities will be described where
appropriate, but most activities occur primarily in EPA
headquarter’s offices.
SECTIONS 1 & 2. TABLE OF CONTENTS, FINDINGS, POLICY, AND
INTENT.

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Section 1. of the Act consists ;of -the title and table of
contents. Section 2 explains the findings, policy and intent
of the Act. It is in the closing paragraph of section 2 where
the dministrator is directed to consider the environmental,
e:onomic and soc4al impact of any action the Administrator
might take under the Act. - In other words, TSCA is a
ri k-benef it statute similar to the FIFRA. As was briefly
mertioned earlier, chemicals subject to review under TSCA, and
reçulations which are promulgated for the control of a chemical
suL stance must be weighed between the health and environmental
berief its to be realized, as against the cost to society for
those benefits. If the social and economic cost is greater
than the beneficial costs, the regulation will not come to
pass. The Administrator must exercise his authority to con-
troll and regulate chemical substances and mixtures which are
inminent hazards in such a manner as not to impede unduly or
create unnecessary economic barriers to technological
innovation. It is readily apparent any chemical control
regulation must be very carefully developed. And as will be
expanded upon under section 9 of the Act, other factors must
also be considered.
SECTION 3. DEFINITIONS.
Section 3 contains the definitions of various terms and words
used throughout the Act. The definitions section of most laws
is often not thought of as being one of the significant
sections of the Act, but that is not necessarily true. Many
actions often hinge on the literal translation, or policies
developed, for the use of a word or term.
The term chemical substance under TSCA is defined as “.. .any
organic or inorganic substance or a particular molecular
identity, including --
0 any combination of such substances occurring in whole
or in part as a result of a chemical reaction or occurring
in nature and
0 any element or uncombined radical.
The definition has been defined further to include biological
or genetically engineered organisms (microbes) which are
considered to be chemical substances. This definition extends
to all microbial biotechnology products which are not covered
under other regulatory authorities, e.g. foods, drugs,
cosmetics, and pesticides. Substances such as alcohol, tobacco
and explosives, and nuclear materials are also excluded from
TSCA.
“Distribute in commerce” and “distribution in commerce” has a
similar meaning as that found in FIFRA. The term(s) means the
introduction into commerce (sale), holding for distribution, or
distribution of a chemical, substance or article.

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“Manufacture TM includes the importation of a chemical substance
into the territory of the US. -
Additional d3finitions found in section 3 include process,
fixture, new chemical substance, etc.
SECTION 4. “ESTING OF CHEMICAL SUBSTANCES AND MIXTURES
Section 4 of TSCA provides the Administrator with the authority
to require such testing as is deemed necessary to assure a
chemical will not constitute an unreasonable risk to health or
the environ 1 uent. Testing may be required to assure any phase
of the manufacture, distribution, useage, storage or disposal
of a chemical substance does not present a hazard to human
health or the environment. Reasons for such testing may
include an insufficient data base to assess human exposure and
potential harmful effects; substantial quantities will be
produced; or the production of a significant, but unknown
quantity may impact the environment.
The Administrator can require health and environmental effects
standards to be established for the development of test data
for carcinogenesis, mutagenesis, teratogenesis, behavioral
disorders, cumulative or synergistic effec ts, etc. Further,
the methodologies for these tests may include epidemiologic
studies, serial or hierarchical tests, in-vitro tests, and/or
whole animal tests. The Administrator must consult with the
Director of the National Institute of Occupational Safety and
Health (NIOSH) before conducting epidemiologic studies of
employees.
At least once each year the standards for development of test
data must be reviewed for adequacy. Proceedings can be
initiated for revision of the standards if warranted.
For those chemicals and mixtures for which testing standards
have been established, any person wishing to manufacture or
process the substance must conduct testing as prescribed. The
administrator will allow two or more persons to designate a
qualified third party to conduct the testing (contract
laboratory in most cases). Any person availing themselves of
the data derived from such testing shall share in the cost of
the testing for the period of the reimbursement period. The
reimbursement period may be of variable length as determined by
the Administrator.
An exemption process exists for those persons who can
demçnstrate the chemical or mixture in question is equivalent
to a chemical or substance for which data already exists, or is
being prepared pursuant to a rule; or the data would be
duplicative of data in existance. Participation in sharing the
costs of research by the exempted party is required if the
exemption is granted during the reimbursement period.

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The reimbursement period is normally five years in length,
unless the period of time to develop the data exceeded five
years, then the longer period applies. The Administrator may
promulgate rules for the determination of fair and equitable
reimbursement by others to the person(s) who developed the
required data.
Test data received by the Administrator pursuant to a rule must
be acknowledged by the administrator in the form of a notice in
the Federal Register within 15 days of receipt. Subject to the
trade secret requirements of section 14, the notice must
identify the chemical substance or mixture for which the data
was received, a list of the uses of the chemical or substance,
and the type of data which was prepared.
To assure the agency keeps abreast of the uses and hazards of
the chemicals used, a special eight member committee was
established under section 4(e). The committee is made up of a
representative of each of the following agencies: the
Environmental Protection Agency (EPA), the Department of Labor
representing the Occupational Safety and Health Act (OSHA), the
Council on Environmental Quality (CEQ), the National Institute
for Occupational Safety and Health (NIOSH), the National
Institute of Environmental Health Sciences (NIEHS), the
National Cancer Institute (Nd), the National Science
Foundation (NSF), and the Department of Commerce (DOC).
Up to fifty chemicals may be placed on the list to which the
administrator should give priority consideration for the
development of test data. The administrator must respond
qithin 12 months from the date cf the list by either initiating
a proceding under section 4(a), or publish within the Federal
Register the reason(s) for not initiating a proceding. The
list will be reviewed every six months by the committee to
determine if revisions are needed, or chemicals should be
added. Priority factors used to determine placement of a
chemical on the list include the ability to cause cancer, or
contribute to the development of cancer, gene mutations or
birth defects. Other factors such as the quantity produced,
extent or potential for human exposure, chemical relationship
to similar chemicals which are known to cause adverse effects
upon human health or the environment, the ability to conduct
such testing, and that the results from such testing would be
useable may be considered.
If data becomes available as a result of testing under the act,
or from any other source, which indicates a chemical substance
or mixture presents or will present an unreasonable risk to
human health or the environment, the administrator has 180 days
to initiate action under either TSCA sections 5, 6, or 7 to
reduce such risk, or publish in the Federal Register a finding
that such a risk is not unreasonable.

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SECTION 5. XANUFAC URING ND PROCESSING NOTICES
ip to this point we tiave not discussed how new chemicals, or
new uses for existing chemicals, are screened before coming
into the market p1ac . Initially, in 1979, aTSCA invento:7 of
all chemicals in use was established. This inventory included
any chemical substance previously made which was in use or had
the potential to be used, and any chemical or substance
imported into the U’iited States for use. After the cutoff
date, all new chemicals manufactured or imported into the
United States, or any significant new use of an existing
chemical as determined by the Administrator, must be submitted
to the administrator for review. In addition to the person’s
intent to manufacture, import or process, data such as would be
produced under section 4 of the act must be submitted if the
chemical is subject to such rule, or such data as the applicant
believes will show the chemical substance will not present an
unreasonable risk to health or the environment. The
administrator (Chemical Control Division) has 90 days to review
the data and make a determination of unreasonable risk
concerning the chemical substance. -
If the applicant has not been advised further information is
required, or the review period has been e;tended, the applicant
then may begin commercial production. Wilhin 30 days of the
first commercial batch, a Notice of Intent to Manufacture must
be submitted to the agency. The new chemical will then be
added to the chemical inventory. The agency also has the
option of allowing the material to be made under special
circumstances. These could be limited volumes, special warning
statements must accompany the product, special packaging or
handling instructions, or allow production while simultaneously
requiring health and/or environmental effects testing under
section 4 to be conducted. If the agency determines the risk
of the chemical is too great, the chemical may be denied
production, or in some manner restricted in its use,
distribution, labeling etc. Chemicals which are produced under
what is known as a Test Marketing Exemption (THE) may be
marketed in amounts up to 1000 pounds. Research and
development chemicals must be accompanied by labeling which
indicates the status of the product. The product may only be
used by research personnel, and any unused portion must be
disposed of as a waste.
SECTION 6. REGULATION OF HAZARDOUS CHEMICAl 1 SUBSTANCES AND
MIXTURES
This is the section of the act most people are familiar with as
a result of the regulations for the ban and phaseout for PCBS.
Other chemicals which have come under section 6 regulations
over the past years are dioxins (now handled by RCRA),
asbestos, hexavalent chromium and to a small degree,

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chlorofluorocar1 óns.(CFCs); Section 6 allows the Administrator
restrict or proh itthe manufacture, processing,
distribution in commerce, -use or disposal .of a chemical
substance or mixture if any activity or combination of
activities might present (will present) an unreasonable risk of
injury to health or the environment. Such action may only
apply to a limited geographic area if the circumstances were
such to justify that approach.
The Administrator may even go one step farther and require an
individual manufacturer or processor to detail his
manufacturing procedures, quality control and assurances that a
product will not constitute an unreasonable risk to health of
the environment The agency may require the manufacturer or
processor to provide notice to purchasers or the general public
of such risk. He may also be required to buy back or replace
the chemical substance in question according to the order given
by the Administrator. The section also includes the provisions
for promulgating regulations, hearings, an opportunity for
comment, and compensation under the rule.
So far as is known, TSCA is the only law where a specific
chemical (PCBS) was identified by Congress directing the
Administrator to develop regulations within six months of
enactment of the law.
SECTION 7. LNHINENT HAZARDS
An ‘Imminently Hazardous Chemical substance or mixture” means a
chemical substance or mixture which presents an imminent and
unreasonable risk of serious or wf.despread injury to health of
the erwironment.
Section 7 authorizes the Administ tor tc commence a civil
action in any district court in tha United States for seizure
of an imminently dangerous chemical substance, mixture or
article containing such a substance or mixture; or to seek
relief against any person who manufactures, distributes in
commerce, processes, uses or disposes of any imminently
hazardous chemical substance or mixture, or article containing
the same. If the situation dictates, the Administrator may
commence simultaneous actions for seizure and relief. Relief
may constitute recall, notice to purcha ers, notice to the
public, replacement or repurchase of the chemical substance or
article containing same, or any combination of the above.
If no rule exists under section 6 for the chemical substance or
article which is considered to constitute an imminent hazard, a
rule will be developed. The action(s) under section 7 provides
the period of time required to protect health and the
environment until the rule becomes final.
SECTION 8. REPORTING AND RETENTION OF INFORMATION

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The Administrator is given the authority to require records and
reports as he deems necessary for the reasonable administration
f the act. The small manufacturer, processor, and research
rind development chemi3t are not exempt from this .requireirent if
it is determined such records are necessary for the effective
enforcement of the ac:. Small manufacturers and processors as
identified by joint agreement between the Administrator end the
Administrator of the Small Business Administration may be
exempted from some rule requirements.
One of the first data gathering aspects of the act was t.he
compilation of the TSCA chemical inventory which was published
for the first time in 1979. The inventory listed all chemical
substances manufactured (imported) or processed in the United
States. The list did not include any chemical which had not
actually been manufactured or processed within three (3) years
of the effective date of the act. Small quantity chemicals for
research and development were also excluded from the inv ’nto y
listing. The initial inventory published in 1979 contained
around 60,000 chemicals. The inventory has been updated twice
since then to include new PNN chemicals and significant new use
rule (SNUR) chemicals.
Section 8(c) requires manufacturers, proce sers and
distributors to maintain records of any significant adverse
reactions to health or the environment which might be
attributed or alleged to have been caused by a chemical
substance. Such records are required. to be retained for 30
years from the date of the first report. These records of
tonsuiner allegations of personal injury or harm to health,
reports of occupational disease or injury, or reports and
complaints of harm or injury to the environment must be made
available to any duly designated representative of the
Administrator, and submit copies if so requested.
Section 8(d) requires the manufacturer, processer or
distributor, or anyone who proposes to do so, or anyone who has
a copy of a health and safety study to submit a copy of the
study to the Administrator. The Administrator may exempt
certain types or categories of studies if he finds they are not
needed for the enforcement of the act.
Going one step further, Section 8(e) requires any manufacturer,
processer, or distributor in commerce of a chemical substance
or mixture who obtains information which reasonably supports
the conclusion that such substance or mixture presents a
subst-antial risk or injury to health or the environment shall
immediately inform the Administrator, unless he has personal
knowledge the Administrator is already aware of the
information.
SECTION 9. RELATIONSHIP TO OTHER LAWS

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As was mentionecr earlier, drugs, pesticides, alcohol,
exploiives and -radiological materials are not regulated by
TSCA. Also,.under the law, if a chemical is identified which
may pose a risk to man or theenvironment, but may be more
advantageously regulated under another law, that law or
regulation will be given the opportunity to reduce the
potential for harm to an acceptable level. Coimnon examples of
such referrals have involved chemicals in the work place where
OSHA worker protection standards have been put in place to
protect employees from excessive exposure to a hazardous
substance. A more recent instance where a chemical was found
to cause a very high degree of risk, but the more appropriate
law of choice for regulation was not suitable, involved
hexavalent chromium use in open comfort cooling towers. The
lung cancer risk from this chemical downwind from the open
water cooling towers was estimated at 1:10,000. To regulate
this chemical, emission and use regulations under the Clean Air
Act were not reasonable. Instead, the regulation was prepared
by the air program, published by the Office of Toxic
Substances, and enforced by the regional toxics programs.
Hexavalent chromium was banned from use in open systems and
manufacturers and distributors were required to maintain
records of sale and other record. requirements.
SECTION 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION
AND UTILIZATION OP DATA
The Administrator has considerable flexibility to enter into
research programs or contract for programs which will generate
data retrieval systems or animal health data. The
administrator may consult with the Secretary of Health,
Education and Welfare, and heads o cther appropriate
departments and agencies as neccss rv. E. amples of this type
of research is the joint funding a! the National Institute for
Cancer Research which is cofunded be:ween the Agency and the
FDA. Joint activities with the Agen -a for Toxic Substances and
Disease Registry, a part of the Centers fcr Disease Control,
but funded by EPA, generate data bases and toxiCs profiles for
a great many substances. Coordination and exchange of
information is promoted at all levels of government, including
state agencies. Training of federal laboratory and technical
personnel is the final aspect of the agency’s efforts to create
more complete and accurate information.
SECTION 11. INSPECTIONS AND SUBPOENAS
The regional programs have their greatest level of activity in
compliance monitoring and enforcement efforts. Any duly
designated representative of the Administrator may inspect 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
:onveyance being used to transport chemical substances,

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mixtures or such article:3 in connection with distribution in
cómmerce. Credentials a:id a proper written notice of
inspection must be presented to the owner, operator or agent in
charge -of the premises or conveyance being inspected. The
inspection need only meet the standards of reasonableness as to
time, place and length.
An inspection may extend t.o all things, physical and
documentary, bearing on the requirements of the act. The
inspection may not extend to financial data, sales data (other
than shipment data), pricing data, personnel data, or research
data (unless by rule or required by the Act) unless the nature
and extent of such data are described with reasonable
specificity in the written notice of inspection.
Examples of inspections which are conducted by the regional
toxics inspectors include PCB inspections, Hexavalent Chromium
use inspections, CFC use inspections, sections 5 and 8
inspections and in some regions, audits of laboratories are
conducted to assure the proper generation of data as required
under a section 4 rule and conducted in accordance with the
TSCA Good Laboratory Practices regulations.
Witnesses may be called by subpoena if the attendance and
testimony of that person is required to carry out the mandates
of the act. Documents, records, reports and answers to
questions may also be required to be submitted. Failure to
comply with the requirements of the subpoena will result in
contempt of court charge being filed against the person.
One or two unique things about this section. Even though th
inspections can (and occasionally are) be conducted by a stat
inspector, there is no provision in the act for state
enforcement. Only EPA can take an enforcement action. Some
states have duplicated the federal statute at the state level
in an attempt to regulate their own investigations, but the
number is quite small.
SECTION 12. EXPORTS; SECTION 13. IMPORTS.
Sections 12 and 13 deal with the export and import of
chemicals into and Out of the United States and the conditions
under which such movement in commerce is allowed. TSCA will
generally not apply to an exported chemical so long as there is
not some order for testing or other evidence the chemical may
cause harm to health or the environment. If such evidence
exists for a chemical which is to be exported, the exporter
must notify the agency so that the country of import may be
made aware of the chemical’s hazards.
Any chemical substance or mixture seeking entry into the United
States must be in compliance with all TSCA regulations. A
certification statement is required stating the chemical is in

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compliance, or a statement which states the chemical substance
or article is not subject to TSCA, which would imply it is
subject to another act (e.g. FIFRA, FDCA etc.). A Memorandum
of Agreement is in effect with the U.S. Customs Service for
primary enforcement of chemical movement into and out of the
United States. Outgoing chemicals are checked for clearance to
the foreign port, and incoming chemicals are checked for the
appropriate certification statement required by TSCA.
This statement is limited to one of two wordings. The first is
for use on a chemical subject to the act which is properly
entered on the TSCA Inventory. The importer must sign the
following statement.
“I certify that all chemical substances in this shipment
comply with all applicable rules or orders under TSCA and
that I am not offering a chemical substance for entry in
violation of TSCA or any applicable rule or order under
TSCA.”
This certification is also required for any microorganism which
is imported into the territory of the United States.
If the chemical substance is regulated by FDA, FIFRA, Alcohol,
obacco and Firearms (ATE) or the Nuclear Regulatory Commission
tNRC), the following statement may be used:
“I certify that all chemicals in this shipment are not
subject to TSCA.”
SECTION 14. DISCLOSURE OF DATA.
Except for specific actions in the performance of official
duties, law enforcement actions, for the protection of health
or as a part of a (judicial) proceeding, it is unlawful for any
employee of the United States or contractor to disclose any
information obtained as a result of activities or requests
under TSCA. Information obtained from a health and safety
study may be released. However, other information, for example
that which deals with processing of the chemical may not be
disclosed.
The manufacturer, processor or distributor in commerce may
designate which information is believed to be confidential.
Specific actions on the part of the agency are required before
such data may be released. A maximum $5,000.00 fine and one
year imprisonment constitutes the maximum penalty for divulging
such information.
SECTIONS 15 & 16. PROHIBITED ACTS AND PENALTIES
There are only four prohibited acts under TSCA, but they are

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pretty all inclusive. It is illegal for any person to 1) fail
or refuse ta comply wit t any rule, order or requirement under
sections 4,5, and 6; 2 use a chemical in violation of the
act either knowingly or if knowledge should have been known; 3)
fail or refuse to maintc in records, reports notices, etc. and
to refuse access to tho,;e records; and 4) fail to permit entry
for inspection. TSCA has been given the same presence under
federal law as FIFRA. A warrant is not required for entry.
The uniqueness of the law, the chemicals being regulated, and
the ability to rapidly hide or cover up violations are viewed
by the court as suffic Lent reason to allow immediate entry for
routine inspections. If the entry is denied, an administrative
warrant for cause may be obtained.
The maximum civil penalty under the act is $25,000 per day per
day of violation. Penalty policies are used to modify the
penalty based on gravity and extent. A knowing and willful
violation constitutes a criminal misdemeanor and may subject
the violator up to one year’s imprisonment as well as the
dollar penalty.
SECTION 17. SPECIFIC ENFORCEMENT AND SEIZURE.
Through the federal district court system the agency can obtain
restraining orders to bar the actions of a person prohibited by
sections 5 or 6. The agency can also compel the manufacturer
or distributor to do certain activities required under the act
or s iè cific actions by order.
Procedures are given for the conduct of civil actions or
seizure. Very seldom is seizure used, however, as it is
generally more difficult for the agency to divest itself of an
item after it has seized it than for the person who is/was
originally responsible for the chemical substance or article.
SECTION 18. PREE} TION.
This section is often misunderstood. In effect the section
says a state can do what ever it wants as long as it is the
same as TSCA, does not countermand any TSCA rule, and does not
interfere with the interstate commerce of the chemical
substance. There has not been a great deal of activity at the
state level to enact sweeping commercial chemical legislation.
SECTION l9 JUDICIAL REVIEW.
A provision exists within TSCA which allows any person to file
a petition seeking judicial review of a new rule within 60 days
of promulgation. The petition must be filed with the United
States Courts of Appeals for the District of Columbia, or the
district in which the person lives. The Courts of Appeal have
exclusive jurisdiction of any action, with the exception of an

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enforcement action. Transcripts, records and modifications may
be suggested’ and/or made to the rule. Following submission and
review of all additional data, a determination is made to
affirm, or set aside the regulation. It is possible for either
party in a suite to appeal the decission all the way to the
Supreme Court. Reasonable costs of the suit and attorney fees
may be awarded to the party if deemed appropriate.
SECTION 20. CITIZENS’ CIVIL ACTIONS.
Any person may commence a civil action against any person, the
United States, or other governmental agency who is alleged to
be in violation of the act, or any rule promulgated under
section 4, 5, or 6, or any order issued under section 5. A
person may also take action against the Administrator to compel
the Administrator to perform any act or duty under the law
which is not discretionary. Suit cannot not be initiated to
restrain a violation of the act, or rule or order under the Act
until 60 days notice is given. No action may be commenced if
the administrator (read agency) is diligently prosecuting a
proceeding for the issuance of an order under section 16(a)(2)
(an enforcement action).
SECTION 21. CITIZENS’ PETITIONS.
There have been at least two occasions here in Region IV where
a citizens’ group has filed a section 20 petition which did not
have slanding. There are only a certain number of situations
where petitions are allowed. A petition may be used to repeal
a rule under section 4, 6, or 8 or an order under section 5(e)
or 6(b)(2). The petition must be filed with the administrator
who has the option of holding public hearings or other investig-
ation as necessary to determine if the petition has merit and
should be granted. A response to the petition must be made in
the Federal Register within 90 days unless an extension of time
is requested. Under certain conditions the petitioner may
commence a civil action to initiate a rule making in an
appropriate United States District Court.
SECTION 22. NATIONAL DEFENSE WAIVER.
The Administrator may waive compliance with any provision of
the Act upon the request and determination by the President
that the waiver is in the interest of national defense. Such a
waiver may not be released to the public if it would be
contrary to the interest of national defense.
SECTIONS 23. EMPLOYEE PROTECTION
A whistle blower provision is in the act to protect employees
against adverse actions which might be brought against an
employee because the employee was in some manner involved in an
investigation or action under the act. The Secretary of Labor

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is empowered to conduct the investigation and determine the
appropriate remedy. Back pay, benefits, compensatory damages
and exemplary damages m y be ordered by the Secretary. A
provision also exists fcir a person to obtain a review of an
order where the employe::, or employee, has been adversely
affected by a rule or order. The petition must be filed within
60 days of the order.
SECTION 24. EMPLOYMENT BENEFITS.
TSCA is known as a risk—benefit law. A rule or order must be
able to demonstrate a greater good to be achieved than economic
cost to society. The Administrator is obliged to continually
evaluate the potential effects upon employment of any action
which might be taken under the act. When an employee alleges
an adverse effect or potential for adverse action because of a
rule, order, or requirement under sections 4, 5, or 6 to the
Administrator, he shall conduct an investigation to determine
the merits of the complaint. The Administrator will make a
report on the results of the investigation, but there is no
provision for repeal or amendment of the rule or order.
SECTIONS 25 THROUGH 31.
The last six sections of the act deal primarily with
administrative issue concerned with conduct of studies,
appropriations and state grants. The grant program is worthy
of some’Uiscussion. The introductory sentence to the section
states any state program is for “the purpose of complementing
(but not reducing) the authority of, or actions taken by, the
- Administrator under this Act, the Administrator may make grants
to States for the establishment and operation of programs to
prevent or eliminate unreasonable risks within the States to
health or the environment which are associated with a chemical
substance or mixture...” Although enforcement is not directly
mentioned, most grants involving PCBs have been for the purpose
of enforcement inspections. Asbestos grants have been under
Title II of TSCA as separate federal acts, or also involved a
degree of enforcement activity. There has been at least one
suit by a private company attempting to nullify the use of
state inspectors for PCB violations. Within Region IV a PCB
cooperative enforcement project grant exists with Kentucky.
Asbestos grants of various types are in effect in all eight
states.
SUMMARY
In recent years, several people including the Administrator and
Assistant Administrator for the Agency have made the statement
that the Toxics Substances Control Act is the strongest
environmental law on the Agency’s long list of statutes. When
one considers the potential of this law to regulate every facet
of the chemical industry through the regulation of individual

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14
chemicals, the law does have awesome potential. It can
litterally dictate every aspect of a chemical’s existance, even
to a greater degree than how pesticides are currently regulated
under FIFRA. Under FIFRA there are no specific regulations
concerning the manufacturing of the product. Until it is
“packaged, labeled and released for shipment...” FIFRA and the
pesticide inspector have little control of the chemical. TSCA,
on the other hand can address manufacturing controls as well
through rule or order. The impact of TSCA will become much
more noticeable in years to come.

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B

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UNITED STATES ENVIRONMENTAL PROTECTICN AGENCY
_____ WASHINGTON. -D.C. :0460 --
i FR 22 :eei
E CCE3 . NC
L STANCES
SO—l2
! 0P ANDt5M
SZJBJECT: Coin uter-Generated ?C3 Records
Jan Bearden, Chief
Toxics Enforcement Policy Branch (EN-342)
Tony Baney, Chief 1
Chemical Regulation Branch (TS -798)
TC: Juliane Matthews
Region 10
Assistant Regional Counsel
Your memorandum of February 11 asked whether there are
Agency enforcement policy considerations when a facility keeps
its annual documents on a computer file, and only generates a
hard copy upon request by the EPA inspector.
Our review of the rule indicates that the’ Agency did not
intend to specify exactly how the annual documents are supposed
to be kept. The premise of your question is that these
facilities are able to produce the printed documents at the. time
of inspection. It would appear in that case that merely keeping
the documents in the form of an electronic file does not
constitute a violation of the rule.
The key to complying with the rule is to have all annual
documents required in 40 CFR Part 761.180 available for
inspection upon request by the Agency inspector. If a facility
chooses to maintain its documents on a computer file, it could be
subject to an enforcement action if the computer is “down” on the
day of inspection, or the operator is not available to retrieve
the file. The rule states that the, documents “shall be available
for inspection” and that “each owner or operator of the facility
subject to these requirements shall know the location of these
records.” Failure to produce a required document at the time of
inspection is a violation of the ‘rule. It would not be
sufficient for a facility owner or operator to simply state that
they have their documents on file, but that for some reason or
another the file cannot be retrieved. Otherwise, anyone could
simply say they maintain their documents, feign computer trouble
P ted on Recyc c ccr

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at the time cf insteczi n, and r duce a ew dccument f:r z e
1nsPect r at some later z .rne.
SimilarlY, the rule does not specify the form cf raccr s f:r
“isual leak ins eczicns under Section 751.30. If a facili:-,
chooses to ccmtuter.ze those records, the same concerns extresse
above will a c1y.
In sulnmar7, keetinc annual dccu ents and insDec :icn rec:r s
cr. a commuter file is nct a v claticn of the CE rules. : cweve:,
failure to have such documents and records available at the zitie
of inspecticn is a violation. We recommend that “hard” cc ies f
all documents and records be kept to ensure that they are
available at the time cf inspection.
We hope that we have answered your question. If you would
like to pursue this question further, there may be a good
opportunity to do so during the April PCB Seminar. Mr. Cary
Secrest (FTS 475—8660) is the contact on this issue and is open
for suggestions if you would like to raise this for discussicn
there.
cc: Regional Branch Chiefs
Regional Counsel
Mike Walker, CE
Jim Nelson, OGC

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C

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• UNITED TATLS NVI c•N .1ENr L O L .l .
T.:... .
jj2fl909
M EMORANDUJM
SUBJECT: TSCK § 5 and 8 Concurrence Prec.ess
FROM: Michael F. Wood, Director Y” - - ’
Compliance Divisioi /
Of f ice of CompliancbMonitorin
I’, / ts”
Michael 3. Walker • ( I L.( b 1 -” -
Assistant Enforcei i t Counsel
Toxics Litigation .Division
TO: Addressees
The Toxic Substances and Control Act (TSCA) section 5 and
8 program has been returned to Regions I, IV, VI , VII, VIII, IX,
and X. During the past four fiscal years, this program was
implemented by the National Enforcement and Investigations
Center. Although the program has been returned to the these
Regions, Headquarters will retain its usual oversight role until
these Regions have gained a measurable degree of experience with
the statute, reguLations, and enforcement response policies.
In 1986 and 1988, EPA Headquarters substantially revised
the TSCA § 8, 12, & 13 and TSCA § 5 Enforcement Response
‘olicies (ERP), respectfully. Both of these ERPs require tha
Regions to obtain Headquarters’ concurrence prior to initiating
and completing TSCA § 5 and 8 enforcement actions.
Attached for your reference are the procedures for
requesting Headquarters’ concurrence and for relaxing the ERP
concurrence requirements. These procedures establish a process
to rapidly respond to your requests. Our ultimate goal is to
relax the cortcurrence requirements as soon as each Region gains
sufficient experienc, in the issuance and settlement of cases in
accordance with the appropriate ERP. We are committed to
working closely with your staff - both technical and legal - tc
maintain the momentum of this important enforcement program and
remajn ready to assist you. Please ensure that these procedures
are made available to all staff members who are enforci.ng this
important reporting provision.
Attachments
000001

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—2—
AddreSSeeS: -
Director, Air Management Division; Region 1
Director, Environmental Services Division; Regions 2, & 5
Director, Hazardous Waste Management Division; Region 3
Director, Air, Pesticides and Toxic Management Division;
Region 4 -
Director, Air, Pesticides and Toxics Division; Region 6
Director, Air and Tox .c Substance Division; Regions 7, 8, & 10
Director, Air Management Division; Region 9
Director, National Enforcement and Investigations Center
Regional Counsel; Branch Chiefs and Acting Branch Chiefs:
Susan Studlien Region I
Wilkie Sawyer Region II
Elizabeth Spencer Region III
Bill Anderson Region IV
Michael Smith Region V
Jim Turner Region VI
Bob Patrick Region VII
Christine Phillips Region VIII
Nina Spiegelman Region IX
Deborah Hilsman Region X

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TSCA § § 5 & 8 CONCURRENCE PROCEDURES
PurOOSe
The purpose of this document is to outline:
1. The procedure for obtaining Headquarters concurrence on
Regional Toxic Substances Control Act (TSCA) section 5 and
8 ComplaintS and Consent Agreements.
2. Eeadquarters’s and Regional responsibilities.
3. The procedure for obtaining relaxation of these concurrence
requirements.
Adherence to these procedures will ensure timely
concurrence on Regional complaints and settlement agreements,
arid relaxation of tnese requirements.
Contacts :
he Headquarters concurrence process requires an
independent review by two Offices, the Office of Compliance
Monitoring (0CM) and the Toxics Litigation Division (TLD) of the
Office of Enforcement and Compliance Monitoring (OECM). Both of
thes. offices have assigned an individual to act as your
regional coordinator. Page 4 of this memo is a current list of
CM’s case support officers and TLD attorneys and their regional
responsibilities.
Your regional coordinator in the Case Support Branch of 0CM
has been designated as the Headquarters contact point for
obtaining case concurrences and relaxation of these
requirements. All, requests for concurrence and relaxation of
concurrence must be sent to:
U.S. E.P.A. Headquarters
Regional Coordinator (e.g., John Foley, region IV)
Case Support Branch (EN-342)
401 H. Street, S.W. - -
Washington, D.C. 20460
Your regional coordinator is responsible for receiving,
tracking, and processing your concurrence requests. Each
request for concurrence will be tracked in a database.
Following the OCX case support officer’s review, the concurrence
request will be forwarded to the appropriate TLD regional
coordinator.
In the event you have questions concerning these procedures
or the status of a request, you are encouraged to call, your 0CM
or TLD regional coordinator, as appropriate. During settlement
negotiations, Regional personnel should also consult with their
ippropriate regional coordinators concerning settlement
000003

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TSCA 5 & 8 CONCURRENCE JCEDURES
ose : -
The purpose of this document is to outline:
i. The procedure for obtaining Headquarters concurrence on
Regional Toxic Substances Control Act (TSCA) section 5 and
8 Complaints and Consent Agreements.
2. Headquarters’s and Regional responsibilities.
3. The procedure for ‘btaining relaxation of these concurrence
requirements.
Adherence to these procedures will ensure timely
concurrence on Regional complaints and settlement agreements,
and relaxation of these requirements.
Contacts :
The Headquarters concurrence process requires an
independent review by two Offices, the Office of Compliance
Monitoring (OCX) and the Toxics Litigation Division (TLD) of the
Office of Enforcement and Compliance Monitoring (OECM). Both of
these offices have assigned an individual to act as your
regional coordinator. Page 4 of this memo is a current list of
OCM’s case support officers and TLD attorneys and their regional
responsibilities.
Your regional coordinator in the Case Support Branch of 0CM
has been designated as the Headquarters contact point for
obtaining case concurrences and relaxation of these
requirements. All requests for concurrence and relaxation of
concurrence must be sent to:
U.S. E.P.A. Headquarters
Regional Coordinator (e.g., John Foley, region IV)
Case Support Branch (EN-342)
401 H. Street, S.W. - -
Washington, D.C. 20460
Your regional coordinator is responsible for receiving,
tracking, and processing your concurrence requests. Each
request for concurrence will be tracked in a database.
Following the ocx case support officer’s review, the concurrence
request will be forwarded to the appropriate TLD regional
coordinator.
In the event you have questions concerning these procedures
or the status of a request, you are encouraged to call your 0CM
or TLD regional coordinator, as appropriate. During settlement
negotiations, Regional personnel should also consult with their
appropriate regional coordinators concerning settlement

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—2—
proposals which are not explicitly addressed in the TSCA § 5,
8, 12, & 13EflforCement Response Policies (ERP).
Another important contact for the Regions is Teresa Little
in the Compliance Branch of 0CM. Teresa is responsible for
servicing the Region’s requests for copies of submitted TSCA
5 & 8 documents and obtaining certified statements. Her mail
code is (EN—342), and her telephone number is (8-382-7835).
Concurrence Procedures and Responsibilities :
1. All enforcement actions and terms of consent agreements
must be submitted to EPA Headquarters, in writing, for
review and concurrence prior to filing these documents with
the Regional Hearing Clerks.
2. The concurrence request (CR) package must include
a. the appropriate concurrence request form,
b. the inspection report.
c. completed IMD certified statements concerning the
Respondent’s TSCA § 5 or 8 reporting status, and (if
applicable) the Inventory Status of suspected “new”
chemical substances.
d. the draft complaint.
3. Failure to supply the iterns noted above, constitutes an
incomplete package and HQ will request resubmission of the
CR package. If a package is complete, HQ may contact the
Region to discuss additional documentation issues.
4. o Attachment A is a copy of a concurrence request form
for the initiation of an enforcement actIon.
o Attachment B is a copy of -a concurrence request form
for concluding an action.
o Attachment C is a request for a certified statement.
Requests for certified statements must be sent to
Teresa Little for processing. She will track your
request and send the completed certified statement to
the requestor. In order to have a completed certified
statement in hand at the time a CR package is being
compiled, HQ suggests that a certified statement
request should be submitted soon after each inspection
which uncovers a potential violation. Depending on
the results of the certified statement, the Regions
may need to obtain an updated certified statement at
the time the case settles or proceeds to Hearing.
000005

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—3—
5. The Regional Program Office must have the CR package
reviewed and agreed to by Regional counsel prior to its
submission to Headquarters. Further the Regional Program
Office and Regional Counsel are jointly responsible for
ensuring that the alleged violation(s) have been adequately
documented
6. Headquarters will review the Complaints and terms of the
Settlement Agreements for their adherence to the TSCA § 5
& 8 Enforcement Response Policy, and the filing
requirements of 40 C.F.R. Part 22.14. Headquarters will
respond to each request within 28 calendar days from the
date of receipt. The 28 day clock does not begin until a
complete CR package has been submitted. Rasubmission may
be required if the CR package is incomplete or incorrect .
7. A Region may not file a Complaint or Consent Agreement with
the Regional Hearing Clerk until Headquarters has
concurred on the filing of the document.
Concurrence Relaxation Process :
Each Region may request relaxation of the concurrence
requirements on an activity-by-activity basis. Once a Region
has successfully issued five TSCA § 5 and five TSCA § 8 civil
administrative complaints, the Region may request the relaxation
of the case issuance concurrence requirement regardless of the
settlement status of the cases. A separate request for
relaxation of the concurrence requirement for case settlement
may be submitted at a later date once any five cases have been
successfully settled.
An action has been successfully issued or completed when a
Region has submitted and filed an action which conformed to the
TSCA § 5, and/or 8, 12, & 1.3 ERP. Requests to relax
concurrence for case issuance or settlement should be submitted
to the Director of the Compliance Division, 0CM. A sample form
memo to request relaxation for either complaint issuance or
settlement of T$CA § 5 & 8 cases is provided as attachment D.
HQ will process requests for relaxation within 28 calendar days
from our receipt.

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—4—
QEGION REGIONAL COORDINATOR TELEPHONE # I MAIL CODES
1 Mary McDonnell (OCM/CSB) 382—4818 / EN—342
Marged Harris (TLD) 475—8696 / LE134P
2 Mary McDonnell (OCM/CSB) 382-4818 / EN342
Jon Silberinan (TLD) 475-8694 / LE-134P
3 Sanda Spencer (OCM/CSB) 382—4844 / EN—342
Jon Jacobs (TLD) 475-8689 / LE—134P
4 John Foley (OCM/CSB) 382—4119 / EN—342
David Batson (TLD) 475—9501 / LE—134P
5 Tony Ellis (OCM/CSB) 382—3705 / EN—342
Jon Jacobs (TLD) 475-8689 / LE—134P
6 Rose Burgess (OCM/CSB) 382—4328 / EN-342
Marged Harris (TLD) 475-8696 / LE-134P
7 Rose Burgess (OCM/CSB) 382—4328 / EN—342
Vincent Giordano (TLD) 475-8693 / LE—134P
8 John Foley (OCM/CSB) 382—4119 / EN—342
Vincent Giordano (TLD) 475-8693 / LE-].34P
9 John Foley (OCM/CSB) 382—4119 / EN—342
Jon Si1ber an (TLD) 475-8694 / LE-134P
10 John Foley (OC!4/CSB) 382—4119 / EN—342
David Batson (TLD) 475-9501 / LE-134P
000007

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TSCA § 5/8 CASE ISSUANCE: Submit t form along ith the Draft
Complaint Inspection Report, and
Completed Certified Statements
Reauest for COnctirrence - Case Issua
RespOfldeflt (Name & Address)
Reaioflal Contacts Region: 1, 2, 3, 4, 5,
name and tel. #L 6, 7, 8, 9, 10
Program Office: Telephone #: 8 —
Counsel: Telephone #: 8 —
Description of Respondent :
Respcndent is a: (chemical mantifacturer)
Date of Inspection? SIC code:
Nature of Violation : (Failure to submit a PMN report for 2 chemical
substances, substance not subject to TSCA §5(e) or (f) and was
distributed to customers; and report for the Inventory Update Rule
for 10 chemical substances):
Gravity Based Penalty Calculations :
ount 1: Hazard Assessment, Major, Level 3, 5 days, $75,000
count 2: Hazard Assessment, Significant, Level 3, 25 days, $250,000
Count 3: Significant, Level 1, 10 chemicals, one day only $170,000
Total ProDosed Penalty : $495,000
Issues of National or Precedential Significance:
Recommended Action :
Concur ____ Nonconcur _____ Concur ____ Nonconcur _____
Date: _______ Date: _______
Reason for nonconcurrence: Reason for nonconcurrence:
Michael F. Wood, Director Frederick F. Stiehl
Compliance Division Associate Enforcement Counsel
Office of Compliance Monitoring f or Pesticides and Toxic Substances
ATTACHMENT A

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TSCA § 9/8 CONSENT AGREENENTS:
i espondent:
ReQuest for Concurreflce
(Name and Address)
•4e Settleme
Docket No.:
Filed: /
Regional Contacts
nam and tel. #)
Program Office:
Counsel:
Gravity-Based Penalty Assessment:
Region: 1, 2, 3, 4, 5,
6, 7, 8, 9, to
Telephone 1: 8 -
Telephone #: 8 -
$
Rationale
% Total Assessed Penalty:
Documentation
Other Settlement Terms : (include actions taken by the Respondent to
come into compliance)
Recommended Action :
Concur ____ Nonconcur _____
Date: _______
Concur ____ Nonconcur _____
Date: _______
Reason for nonconcurrence:
Reason for nonconcurrence:
Michael F. Wood, Director -
Compliance Division
Office of Compliance Monitoring
Frederick F. Stiehi
Associate Enforcement Counsel
for Pesticides and Toxic Substances
000009
Pro osed Penalty
Reductions:
Amount
Percentage
—S
%
—S
%
—S
%
ATTACHMENT P

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- :.. j £N’ ON’ .’ 4 RC E ’,\ AG :.
- —
MEMORANDUM
SUBJECT: Request for TSCA § 8 Certified Statement
FROM: Sherry Sterling, chief
Compliance Branch
Office of Compliance Monitoring (EN—342)
TO: Frank Caeser, Chief
Confidential Data Branch
Information Management Division (TS—793)
Attached is a certified statement which will be used as
evidence in a Regional Toxic Substances and Control Act (TSCA)
§ 8 enforcement action. The Facility’s name and address, the
calendar year and chemical for which they were required to
report has been supplied by the Region. The remaining
information is needed from IMD to fully document the violative
acts.
Please send the completed Certified Statement to Teresa
Little, and she will forward it to the appropriate Region.
Attachment
ATTACHMENT C

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C TIpIED STAT K1IT
i, Linda A. Travers, am the Director of the Information
Management Division. The Information Management Division of the
office of Toxic Substances is responsible for the receipt of
forms submitted pursuant to section 8 of the Toxic Substances and
Control Act. I certify to the following facts:
EPA received an EPA Form from the Facility noted
below and assigned this submission the Document Control Number
listed below.
DOCUMENT CONTROL NUMBER:
POSTMARX DATE:
FACILITY NAME:
FACILITY ADDRESS:
CALENDAR YEAR REPORTED
CHEMICAL OR
CHEMICAL CATEGORY NAME:
Linda A. Travers, Director
• Information Management Division
Date
ATTACHMENT C, PAGE 2
000011

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ENvlRQN\1EN __
r _ ,
MEMORANDUM
SUBJECT:
Relaxation of Concurrence to Issue and/or Conclude
Civil Administrative Actions for violations of Section
5 of the Toxic Substances and Control Act (TSCA)
FROM:
TO:.
Region
Director
Division
Michael F. Wood, Director
Compliance DiviSiofl
Off ice of Compliance Monitoring (EN—342)
This memorandum is to request the relaxation of the
requirement to obtain Headquarters concurrence prior to the
issuance (or settlement) of TSCA § 5 civil administrative
actions. Region has successfully issued (or settled) the
following administrative actions:
Complaints Successfully Issued (or Settled)
1. In re:
Docket #:
i led:
TSCA §5 violation(s):
2. In re:
Docket #:
filed:
TSCA §5 violation(s):
3. In re:
Docket I:-
filed:
TSCA §5 violation(s):
4. In re:
Dccket #:
filed:
TSCA §5 violation(s):
Tii .
. aa. t .
Docket #:
filed:
TSCA §5 violation(s):
Each of these cases was issued (or settled) in conformance
with the TSCA section 5 Enforcement Response Policy. Copies of
the filed complaints, consent agreements and final orders were
forwarded to our 0CM, Case Support Branch, Regional Liaison in
accordance with standard operating procedures. -
If you have any further questions concerning these cases or
Region’s TSCA section 5 compliance program, please contact
at FTS- . I look forward to receiving your favorable
response.
ATTACHMENT D

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—3—
Example 2 — EPA requested a company to submit any al-
legations of effects attributable to chemical V. The
company reported that no allegations of effects of any
kind were made to them. An Inspector visited the com-
pany 2 years later and found a file for chemical V which
included 3 allegations of bird kills attributed to the
chemical. - Failure to report, level 1, significant, 3
C CU fl t 5.
$17,000 + 364 X $17,000 x 3 $154,134
180
Failure to report — (1 yr. cap) — $154,134
Example 3 — EPA requested a company to submit any al-
legations of effects attrlbutable to chemical V. The
company reported that no allegations of effects of any
kind were made to them. A year later they contacted the
Agency and informed us that they Just found 4 old al-
legations of human effects attributable to chemical V
and submitted the allegations within 10 days. Late
submission, level 4, significant, 4 counts.
$6,000 + 360 X $6,000 x 4 $72,000
180
Late reporting — 361 days x 4 - $72,000
Example 4 — An inspector visited a company and asked to
see the company’s ISCA §8(c) fIles. The company informed
the inspector that any allegations by workers were kept
in the Individual workers personnel files. Failure to
keep files In a manner prescribed by the rule, level 3,
significant, one day assessment, no per day penalty. $10,000
Example 5 — An Inspector visits a company and when inspecting
their TSCA §8(c) file discovers that the files are organ—
Ized by the health effect rather than by the cause of the
health effect. The files are otherwise In compliance with the
rule. Failure to keep files In a manner prescribed In the
rule, level 3, significant, one day penalty. $10,000
0031 1

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-4-
TSCA §8(d )
Example 1 — A company submits a list of ongoing studies they
are sponsoring but fails to list a study involving humans.
EPA discovers the violation. Failure to report, level 1,
major. -
Discovered after 365 days — $75,556
$25,000 + 364 X $25,000 = $75,556
180
Discovered after 1,095 days - $176,944
Discovered after 2,000 days — $278,333 (5 yr. cap)
Example 2 - A company submits late an animal study in the
company’s possession during the Initial reporting period.
Late reporting, level 4, significant.
Reported to EPA after 365 days — $18,133
$6,000 + 364 X $6,000 = $18,133
‘pp
Reported to EPA after i,095 days — $42,467
Reported to EPA after 1,825 days — $42,467 (3 yr. cap)
Example 3 — A company submits an animal study, EPA finds ad..
ditional reportable Information that the company Intentionally
omitted from the submitted study report. False reporting,
level 1, sIgnificant.
Discovered after 365 days - $51,378
$17,000 + 364 X $17,000 = $51,378
‘op
Discovered after 1,095 days - $120,322
Discovered after 1,825 days $120,322 (3 yr. cap)
Example 4 — A company submits a list of 9 ongoIng animal
studies and later submits 10 studies. Late reporting of one
study, level 4, signIficant.
Submitted to EPA 365 days after list submitted — $18,133
$6,000 + 364 X $6,000 $18,133
180
Submitted to EPA 1,095 days after list submitted — $42467
Submitted to EPA 1,825 days after list submitted — $42,467
(3 yr. cap)

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V.
—
;• I
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
•c. WASHINGTON. 0 C 20460
.
I 2
F Ic 0
P IflCIOCS ANO YO*IC SUSSTANCE5
ME MO P AN DUM
SUBJECT: 015/0CM Joint Inspection Program
Fiscal Year 1988, Second Quarter
FROM: . E. Conroy IC, Director
Office of Compliance Monitoring (EN—342
TO: Charles L. Elkins, Director
Office of Toxic. Substances (TS—792)
During the past several weeks, staff members from the
Office of Compliance Monitoring (0CM) and the Office of Toxic
Substances (OTS) have discussed the posslblillty of establishing
a joint inspection program. The goal of this program is to
provide a routine, practical, and “in—context” avenue for 015
personnel and 0CM Inspectors to exchange information. The
means to accomplish this goal is to get OTS personnel out of
the office and Into the field with the 0CM Inspectors.
My understanding of this program is as follows:
o 0CM will target the inspection, determine what particular
OTS expertise would be most beneficial for the inspection,
lead the inspection, and make the necessary arrangenents for
a smooth and efficient inspectional trip.
o 0CM will then forward the attached memorandum to the appropriate
OTS Division Director for their approval. Once approved,
the memo will be forwarded to OTS Office of Program Ianagement
and Evaluation.
o OTS will provide the funds needed for the OTS employee to
accompany the Inspector. OTS will fund one Inspection trip
per quarter per Fiscal Year. Therefore, funding for this
program Is not required from Divisional or Branch travel
accounts.
000013

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-2
I am enthusiastic about this program and wish to Initiate it
this month. If you approve of the program as outlined above p1eas
sign below, return a photocopy of this memo to me, and forward
the attached memorandum to Linda Travers. Otherwise, if you
have any reservations about this proposed program, please call
me to discuss your concerns.
approve of the joint inspection program outlined above.
/7 4 (_ 1 /
c 4 e /
Charles 1. ElkIns, Director
Office of loxic Substances
Attachment
cc: Janet P. Thompson, Director
Office of Program Management & Evaluation
Jan L. Lane, Chief
Management Staff

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$P 4 ,

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
L iiiiolt • -
oFrici 0,
P(1TiClO($ ANO Y0*IC IUISTANCES
M EMO RAND U M
SUBJECT: OTS/OCM Joint Inspection Program
Fiscal Year 1988, Second Quarter
FROM: Ken Shiroishi, Director
Compliance Division 1”
Office of Compliance Monitoring (EN—342)
TO: Linda Travers, Director
Information Management Division
Office of Toxic Substances (TS—793)
The Office of Toxic Substances COTS) and the Office of
Compliance Monitoring (0CM) have recently agreed to sponsor a
joint inspection program. Under this program 0CM will invite,
on a quarterly basis, one OTS employee to accompany an 0CM inspector
on an inspection trip. OTS has agreed to pay the travel expenses
for the OTS employee. The purpose of these special inspections
is to provide a routine, practical, and “in—context” avenue for
OTS personnel and 0CM inspectors to exchange information.
Under this program, the National Enforcement Investigations
Center has requested that Mark Scoville accompany Inspector
William Palmer to Rhode Island to conduct TSCA inspections of
three facilities. The inspection trip will last 5 working days
and will begin in either the last week of January or the first
week of Feburary. The exact dates will be worked out between
Mark Scoville and Bill Palmer.
000015

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—2—
If you approve of this request, please sign below and forward
this memo to Jan Lane (OPME). Jan will then coordinate with Mark
Scoville to prepare his travel authorization.
I approve of the above requested travel for Mark Scoville.
Linda Travers, Director
Information Management Division
cc: Susan Vogt, Deputy Director
Office of Toxic Substances
Janet P• Thompson, Director
Office of Program Management & Evaluation
Dean Full, Chief
Pesticides & Toxic Substances Branch
National Enforcement Investigations Center
-4 & - / ‘ ,_/_
//
/
/

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Sri,
TI
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
4 oO1
13W 8t 89
orrscc or
Pt$TICID I ANO YOXSC SUUSTANCES
MEMORANDUM
SUBJECT: Amendment to the TSCA S5 Enforcement Response Policy
FROM: John J. Neylan III, Director ‘
Policy and Grants Division
Office of Compliance. Monitoring
TO: Addressees
This memorandum amends the TSCA S5 .Lni a.cejn.ent Response
Po 11 cy by
of apply t t1Te iii
stances where a compa-nyif s submitted a Notice of Commencement
in anticipation of production or importation, the event
does not occur, and the company never does produce or import
he substance..
This change has been made in response to numerous comments
that the policy issued on August 5, 1988, created a large in-
equity in penalty when a company submits a Notice of Commence-
ment but does not produce a substance, as compared to a company
that produces a substance without submitting a Notice of Com-
mencement. In the first situation, the current ERP requires
that the violation be charged as a false NOC and would subject
the violator to per day penalties from the day the false NOC
was submitted to the day of discovery of the violation with the
potential of very large penalties. The provision to allow for
per day penalties for each calendar day a falsification occurs,
was created for those situations where t e falsification pre-
vents the Agency from making a reasoned evaluation of the chem-
ical substance. This is not the case for a false NOC. The
chemical has been reviewed and mistakenly placed on the Inven-
tory. A reasoned evaluation of the chemical substance has
been made.
Attached are the two pages affected by the change with the
necessary revisions incorporated. These pages may be inserted
into the TSCA S5 ERP in the appropriate places. If you have
any questions concerning the revisions please contact David
Stangel of my staff at 382—3477.
Attachments

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GRAVITY BASED PENALTY MATRIX
Circumstances Extent
A B C
Major Significant Minor
- Levels
1 125,000 $17,000 $5,000
High Range
2 $20,000 . $13,000 $3,000
3 $15,000 $10,000 $1,500
Mid Range
4 $10,000 $ 6,000 $1,000
5 $ 5,000 $ 3,000 $500
Low Range
6 $ 2,000 $ 1,300 $200

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
AUG 5
o..ucc 0,
PESTICIDES AND TOXIC SUSITANCES
MEMORANDUM
SUBJECT: TSCA $5 Enforcement Response Policy
FROM: Phyllis E.
Acting Director
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
Attached Is the final TSCA 55 Enforcement Response Policy
(ERP) which incorporates the comments received on the February
22, 1988 draft. A summary of the comments and the response to
those comments are also attached. We appreciate the time and
effort spent In reviewing the draft and providing the detailed
c om men ts.
The final ERP has been revised In the following areas:
The policy now addresses all exemption categories found
under 40 CFR Part 723. One major change is that failure
to notify violations are treated differently. depending
on what action the Agency may have taken on the chemical 1
i.e., chemicals which otherwise qualify for an exemption,
versus those which go through PMN review without any con—
cerns,and those chemicals which are possible candidates
for a TSCA 55(e) or 5(f) actIon.
The c lrcuustance levels for failure to notify violations
and commercial use violations have been changed and com-
mercial use violations associated with manufacturing are
no longer treated as a separate violation when the manu-
facturer Is the person who is commercially using the
chemical. Exceptions are made when the number of days of
manufacture and the number of days of processing or com-
mercial use are disproportionate and In Imminent hazard
situations.
Genetically altered, naturally occurring and low risk
genetically engineered microorganisms are now addressed
in the ERP.
oooo 7

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JUN 8 1989
AMENDED
TSCA SECTION 5
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITOR.ING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U. S. ENVIRONMENTAL PROTECTION AGENCY

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—2—
The UP takes Into account whether a substance remains
at the site of manufacture or leaves the site of nanu—
facture when determining the circumstances of the yb—
1 ation.
A quick reference chart has been included as an attach—
rnent so that a case preparation officer may 1 once he/she
becomes familiar with the ERP, more quickly determine
the penalty associated with a violation. Please be
advised that extent determinations are not always based
on pounds of chemical substance involved in a violation,
and the quick reference does not Include the full dis-
cussion on extent.
The ERP has been reformatted by placing the Gravity Based
Penalty Matrix after the extent section, so that a
person using the ERP would determine the nature, circum-
stances and extent of a violation and then turn to the
matrix to determine the penalty amount.
The section on Injunctive Actions has been expanded to
clarify when injunctive actions should be considered.
If you have any questions concerning the UP, please address
them to David Stangel of my staff at 382—7825.
Attachments
000019

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Charles ElJdns (T5—792)
Susan ‘Jbgt (TS—792)
Fralerick F. St1 il (LE-134A)
? rk Greei ood (LE- 132A)
A. E. C iroy II (EN—342)
C iie Misgrove
Ke iiroishi
Pftyuis Flaharty
John 3. Neylan 111
Jerry Stuths
t’ ure L i
i Carison
Jake P k izie
tern Regicxial caipliarre Director
I 14XL1S F. Gitto, Director ? xvin se stein, thief
Air ) eiuit Division Pesticides & dc Substarres Br
II Barbara ! tzger, Director &nest Regna • thief
wi ital Services Div Pestici & !1 idc 3ibstarres Br
III Ste t R. Wasser ig, Director Larry Miller, thief
}b2 r J5 Waste )tbn it DiV ¶Ibxic & Pestici && II
IV Wthston A. 9nith, Director Richard DiBose, thief
Air, Pest. & ‘1 cics ngt . Div Pestici & 1 dc 3.tstaires Br
V William H. Sarders III, Dir Phyllis Reed, thief
jLUIII it31 Services Div Pesticides & cic &ibstarres Br
VI Wiuian B. Hathaiiay, Dir Rebert Marrfly, thief
Air, Pesticides & cic Div Pesticides & cic 9.ibstarres Br
VII - William A. ratl1n, Director Leo A] rii n, thief
Air aid dcs Division Pesticides & 1 dc &ibstares Br
VIII Irwin L. Dieketein, Director Alvin Yorjce, Chief
Air aid Division !I cic Substarres Brarh
DC Jeffrey ZellcJwon, Director E vis Bernstein. thief
‘Ibxics aid br ste P nagai ’it Div Pesticides & ¶Ibxics Brarrh
X Gary O’Neal, DiL -tor K eth Feigner, thief
Mr aid cics Division Pesticides & lbxic Sibstarres Br
cc: Michael Walker (LE—l34P)
! ‘ rgaret stker ( ‘15—788)

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Response to Comments
Comment
One commenter requested that the definition of Notice of Com-
mencement on page 2 of the ERP be amended to read: “Under 40
CFR 720.102, CPA requires that any person who commences the
manufacture or importation of a new chemical substance for
which that person had previously submitted a PMN, must submit
a notice of commencement of manufacture or Import on or no
later than 30 days after the first day of manufacture or
import.’
Response
The definition has been amended as requested.
Comment
One commenter requested that the first factor for calculation
of the gravity based penalty on page 5 be amended to read:
“Impact on the Agency’s mandate to evaluate the potential for
human health or environmental effects of a new chemical sub-
stance prior to Its production or import.”
Response
The first factor is amended as requested.
Comment
One commenter requested that on page 7, under Chemical Control
Violations, “Commercial use of an illegally, produced substance.
be amended to read: “Commercial use of a substance produced
without a PMN or valid exemption.”
Re ’sponse
The ERP has been amended throughout to reflect this change.
Comment
A number of persons commented on the fact that not all exemption
categories in 40 CFR 723 were addressed in the.ERP.
Response
The ERP has been amended to address violations of all the exemp-
tion categories under 40 CFR 723.
000021

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—2—
Comment
One person commented that processing of an illegally produced
chemical substance by the company tnat manufactured the sub-
stance Is almost an inevitable part of the manufacturing pro-
cess and that the previous policy of charging two counts when
this occurs is unfair 1 Even If the substance never left the
manufacturer’s control, the penalty essentially doubles because
the manufacturer processes the substance. The commenter sug-
gested that the ERP should charge only one count when a man-
ufacturer produces and processes an Illegally produced sub-
stance, namely failure to submit a PMN, but raise the cir-
cumstance level when this occurs.
Response
The policy has been amendedto charge only one count when a
manufacturer both produces and processes an illegal chemical
substance, but raises the circumstance level one level when
this occurs. However, there are certain exceptions described
in the policy.
Comment
One person commented that while the policy did address genetic—
ally engineered microorganisms, it did not address genetically
altered, naturally occurring or low risk categories of organ—
I sms.
Response
The discussion under extent has been amended to address genet-
ically altered, naturally occurring or low risk categories of
organi sms.
Comment
A number of cominenters asked for examples of how the policy
is applied to various fact patterns.
Response
Appendix 1 has been added to provide the user of the policy
with examples of how the policy is to be applied.
Comment
One person commented that the ERP allows environmental benefi-
cial expenses to be deducted from a penalty where the action
was requested but not required by EPA, but gives no similar
allowance to a company that may undertake the same actions
independent of any request by EPA.

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—3—
Response
The ERP has been revised to allow credit pursuant to the TSCA
Penalty Policy to companies that undertake environmentally
beneficial actions.
Comment
A nt4mber of persons commented on the fact that the length of
the ERP made it cumbersome to work with when trying to deter-
mine a penalty.
Response
Two revisions have been made to address thl.s comment. First,
the ERP has been reformatted. by placing the Gravity Based
Penalty (GBP) Matrix after the Extent section, so that a per-
son using the ERP would determine the nature, circumstances,
and extent of the violation and then turn to the GBP matrix
to determine the penalty amount. Second, a quick reference
chart has been made so that a case preparation officer could
use the quick chart to calculate the penalty, after they be-
come familar with the revised ERP.
Comment
A number of persons had questions concerning the definition
of certain terms used In the ERP and requested that the UP
contain a definition of these terms.
Response
A definitions section has been added.
Comment
One commenter remarked that the terms “distribution to others,”
“further processed for commercial use by the company,”
“further processed by another firm,” “distributed to consumers,”
and “released uncontrolled into the environment” are used as
the basis for heavier penalties while the rationale for appli-
cation of these terms was unclear.
Response
All the terms used as a basis for assessing heavier penalties
show an increase in potential exposure to the chemical sub-
stance by either workers, the public, or the environment.
000023

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41; 5
TSCA SECTION 5
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U. S. ENVIRONMENTAL PROTECTION AGENCY

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TABLE OF CONTENTS
INTRODUCTION -
Summary of Rules/Requirements.....
.. .
. . . ..
..
. .. . .
1
DETERMINING THE LEVEL OF ACTION
Admi ni strative Civil Penalty... .. .
. . .
.. . . .
. . . .
....
.....
2
Injunctive Actlon...........
...
.....
....
.
3
Criminal Sanctions... ,....... •1e••
•1S
• • •,,
•,,•
. . •.
.. ...
4
ASSESSING A CIVIL ADMINISTRATIVE PENALTY
SummaryofthePenaltyPolicy..........................5
Background... ..... . ..... . S.. S •• •• • •••.•. .... .... 5 •• 5
Applicabillty....................................... 6
Calculation of the Gravity Based Penalty........... 6
Mature.............................................. 7
Circumstances. ...... .. .. ... . . .. . . ....... .... •.... ... 8
E xtent.............................................. 13
G ravity............................................. 15
Per—Day Assessments.................. 15
One—Day Violations...... . .. . • . . . . ... ... .... . • • ... ..• 15
Imminent Hazard..................................... 16
Gravity Based Penalty...... . ...••..••. • . . . .. . . .. . .. . 16
Adjustlngthe Gravity Based Penalty................. 17
Voluntary Dlsclosure................................ 17
History of Prior Violation. .... .. .. .......... .... ... 19
Culpablllty......................................... 19
ExplanatIon ofthePenaltyPol lcy...................... 20
Nature. •.............. .......... •... • •..... .... ... 20
Clrcumstances...................................... • 21
Extent. .............. .... . 5• ••IS••SSSS ........ 22
Gravity of the Violation.. .... .... ....... ........... 25
Adjustment Factors.............,.................... 27
000025

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1NT UDUCIION
Section 5(a)(1) of the Toxic Substances Control Act (TSCA)
requires chemical manufacturers and importers to notify EPA
90 days prior to manufacturing or importing a new chemical
substance in the United States. EPA will evaluate the new
chemical subsfance within 90 days based on the information
supplied by the submitter. If the Agency finds that the infor-
mation supplied Is insufficient to permit a reasoned evaluation
of the health or environmental effects of the chemical substance
and that in the absence of such Information the manufacture,
distribution, use or disposal of the chemical substance may
pose an unreasonable risk of injury to (tealth or the environ-
ment, or that the chemical substance may be. produced in sub-
stantial amounts which may result in significant human or
environmental exposure, the Agency may issue an order under
TSCA §5(e) to prohibit or limit the manufacture, distribution,
use or disposal of the chemical substance. ISCA S5(a)(2)
allows the Agency to identify uses of a chemical substance
which EPA has determined are significant new uses and to require
notification of those significant new uses. Certain exemptions
from the full reporting and notification r .qu1rements are allowed
under TSCA §5(h). These exemptions may be found at 40 CFR 720.30
through 720.38 and at 40 CFR Part 723. The major exemptions
from notification are research and development, test marketing,
small quantities (less than 1,000 kg per year), certain polymers
and substances used in Instant photographic and peel—apart film
articles.
Failure to comply with the provisions of TSCA §5 Is a
violation of TSCA §15 and subject to the remedies found in
TSCA §16.
Summary of TSCA 5 Requirements
Premanufacturing Notification (PMN ) — Under TSCA §5(a)(1) and
40 CFR 720, manufacturers and importers of new chemical
substances are required to submIt, 90 days prior to manufac-
turing or Importing, a notice of their Intention to conduct
such activittes as well as any test data in their posesslon
or control 1 accordance with 40 CFR Part 720.50.

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—2—
Significant New Use Rules (SNUR ) — Under TSCA §5(a)(2) and
40 CFR 721, EPA specifies by rule the use(s) of chemical
substances which it considers to be significant new uses.
EPA must be notified prior to commencement of any significant
new use.
Notice of Commencement(PIOC ) — Under 40 CF 720.102, EPA re-
quires that any person who commences the manufacture or Im—
portatlón of a new chemical substance for which that person
had previously submitted a PMN, must submit a notice of
commencement of manufacture or import on or no later than
30 d,a’ys after the first day of manufacture or import.
ISCA §5(e) Order — Under ISCA §5(e), If EPA determines that
the information available in support of a PMN is insufficient
to make a reasoned evaluation of the health or environmental
effects of a chemical substance, EPA will issue an order
imposing controls, restrictions or prohibitions on the manu-
facture of the substance In order to address the concerns
of EPA.
TSCA §5(f) Order — Under TSCA §5(f), if EPK finds that the man-
ufacture, Import, processing, distribution, use or disposal of
a chemical substance presents or will present an unreasonaDle
risk of injury to health or the environment before a rule
promulgated under TSCA $6 can protect against such risk, the
Administrator may Issue an immediately effective proposed
rule to impose controls or restrictions to protect against
such risk or may Issue an Order to prohibit manufacture,
processing, or distribution in commerce.
TSCA §5(h) Exemptions — TSCA §5(h) and 40 CFR 720.30 through
720.38 and 40 CFR 723 exempt certain substances and classes
of substances from the full notification and reporting require-
ments of TSCA §5.
DETERMINING THE LEVEL OF ACTION
Enforcement alternatives Include civil penalties, injunctive
relief, criminal action or some combination of these actions.
Notices of noncompliance are not appropriate for TSCA 55
violations.
Administrative Civil Penalty
An administrative civil penalty will be the appropriate
response for most violations of these regulations.
000021

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—3—
Concurrence
Civil penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring (0CM) of the Office of
Pesticides and. Toxic Substances prior to initiating a civil
admi ni strative penalty for TSCA 55 violations. Reductions for
settlement purposes require the concurrence of 0CM as well and
must be in accordance with the TSCA Penalty Policy and this
Enforcement Response Policy.
Each reduction must be based on the TSCA Penalty Policy
or this policy and justified in the Consent Agreement and
Final Order with specific dollar amounts attributed to each
reduction. Headquarters may relax concurrence requirements
on a Region by Region basisafter the Regions have gained
experience with actions under these rules and this policy.
Injunctive Action
In most circumstances, a ISCA §16 admfnlstrative action
will provide a complete and timely remedy for ISCA $5 viola-
tions. However, certain cases may present the need for the
types of injunctive relief available under TSCA §17 in addi-
tion to TSCA §16 adminIstrative actions.
Section 17 provides the U.S. District Courts with the juris-
diction to:
— Restrain persons from taking actions prohibited by TSCA §5
5, 6, and 15.
— Compel persons to take actions required by TSCA.
— Direct manufacturers, importers, or processors in violation
of ISCA to: provide notice of the violation or risk of in-
jury to, or repurchase the product from, the consumers of
the violative product.
— Seize any chemical substance manufactured, imported, pro-
cessed, or distributed in commerce In violation of TSCA.

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-4-
It Is important to note that ISCA §17 does not require
an Imminent hazard or recalcitrant respondent as a condition
to its use. However, the Agency believes that the use of
TSCA §17 should be limited to those Instances where a civil
penalty action will not mitigate a hazardous situation, Is
not likely to result in timely compliance, or where penalties
alone do not provide a complete remedy. Injunctive action is
appropriate in the following examples:
• illegal production/use which presents a hazard to human
health or the environment;
• violations of TSCA §5(e) or 5(f) orders, Low Volume Ex-
emptions, or Test Marketing Exemptions which involve
the failure to use personal protective, equipment or
chemical control measures;
• contumacy, undue delay., or refusal of a violator to
comply with TSCA requirements and regulations; or
• repeat offenders for whom the penalty adjustments for past
history of violations is unlikely to deter future violat1on .
Criminal Sanctions
Criminal sanctions pursuant to TSCA §16(b) are the most
serious sanctions available for violations of TSCA §5.
Accordingly, criminal sanctions may be sought in situations
that, when measured by the nature of the conduct, the compli-
ance history of the subject(s) and the gravity of the conse-
quences to human health or the environment, reflect the most
serious cases of misconduct.
000029

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—5—
- ASSESSING A CIVIL ADMINISTRATIVE PENALTY
Summary of the Penalty Policy
Background -
The ISCA Civil Penalty Policy 1 published in the Federal
Register on September 10, 1980, establishes a system for deter—
mfr.tng penalties In administrative actions brought pursuant to
TSCA $16. Under that system, penalties are determined In two
: ;; u
To d penalty, the following factors
affecting a violation’s gravity are considered:
• The of the violation.
• The E cunft&11’t s” of the violation.
• The e flWt” or potential for harmthat could result
from a given violation.
These factors are incorporated into a matrix which allows
determination of the appropriate gravity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made in con-
sideration of these other factors:
•
1 t$iy
- • a11*ty-topay ,
• amity to COitTflue frbiiIfness, and
s u ch...olhe r— i tatteY Ts -jUstTcrlway- req u I r e.

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—6—
The ISCA Civil Penalty Policy system provides a framework
for the development of Individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the Gravity Based Penalty Matrix to
assess penalties for specific violations of TSCA $5 and regula-
tions promulgated pursuant to this section.
pplicability -
This policy is Immediately applicable and should be
used to calculate penalties for all administrative actions
concerning TSCA §5 Instituted after the date of this policy.
regardless of the date of violation. Pending cases should
be reviewed to determine whether the penalty calculated under
this policy is lower than the penalty in the civil complaint.
If this policy yields a lower penalty, an amendment to the
complaint should be made to substitute the lower penalty.
This policy should not be used to raise penalties in
existing actions. No case should be settled for an amount
higher than the penalty which this policy would yield.
Calculation of the Gravity Based Penalty
Penalties for TSCA §5 violations vary depending on the
nature, extent, circumstances and whether penalties are to be
calculated as one—day assessments or per—day assessments. In
establishing each of these, the Agency considered the following
factors in a comparative manner:
Potential for and/or the relative degree of harm to
human health or the environment caused by failure to
comply. This directly relates to the Impact on the
Agency’s mandate to evaluate and control the poten-
tial for human health environmental effects of a
new chemical substance prior to its production or
Import.
• Potential exposure of the public or the environment
to an unregulated new chemical substance.
• Impact on the validity of the Inventory, which the
statute mandates the Administrator to keep current.
• Deterrent effect the penalty would have or the like-
lihood that the penalty will deter future violations.
000031

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—7—
Nature
fl L f the TSCA violation depends on whether the
violation re es to chemical control, control—associated data—
gathering, or hazard assessment. It is important to make this
determination first. Determining the nature of the violation
is necessary prior to using the extent matrix. The following
list places the violation types in their respective categories.
1) ChemIcal Control Violations
• Noncompliance with TSCA §5(e) or 5(f) orders,
rules, or injunctions and significant new use rules
(those aspects dealing with the actual control of
the substance, i.e., production, commercial use,
disposal, production restrictions, etc.).
• Noncompliance with research and development exemption
restrictions (noncompliance with the adequate warning
and supervision of a technically qualified Individual
requirement).
• Noncompliance with test marketing exemption
restrictions (those aspects deal ng with the
actual control of the substance).
• Noncompliance with exemption restrictions under
40 CFR 723 (those aspects dealing with the actual
control of the substance).
2) Control—Associated Data—Gathering Violations
• Noncompliance with the recordkeeplng provisions of
TSCA §5 orders, rules, or injunctions.
• Noncompliance with the recordkeeplng provisions of
exemption restrictions under 40 CFR 723.
• Noncompliance with the recordkeeping provisions of
the research and development and test marketing
exemption restrictions.
3) Hazard Assessment Violations
• All failures to notify EPA when such notification 7
is required by law. / /1 )
I. 5ft’ 1 :/P 5
• Withholding material information from or submitting
false or misleading Information in a ISCA §5 notice
or exemption request.
• Commercial use of a substance produced without a
PMN or valid exemption.

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-8—
• Noncompliance with the reporting provisions of
TSCA 55(e) or 5(f) orders, rules, or Injunctions.
• Any violation not listed previously.
Circumstances
Once the nature of the violation has been determined, the
second step irrcalculating the penalty Is determining the c4.—
cumstaflç , of the violation. The circumstances determination
is based upon the probability that harm could have taken
place — an a priori potential for harm to the environment or
the Agency’s decisionmaking or ability to regulate, I.e.,
potential exposure to an unregulated chemical substance or
harm to the Integrity of the Inventory.’ Any after the fact
determination that harm did or did not take, place is irrele-
vant to the initial circumstance level determination. The
gravity based penalty matrix provides for six circumstance
levels. Levels one and two represent the Agency’s determina-
tion of circumstances where there exists a high probability
of harm. Levels five and six represent circumstances of low
probability of harm and levels three and four fall between
these high and low probabilities.
The circumstance level of a violationis designated in
the following manner.. Please note that many of the levels
refer to a PMN being subject to a TSCA 55(e) or 5(f) action.
Please refer to page 22 for a further explanation of when a
substance Is subject to a TSCA §5(e) or 5(f) action.
Failure to Notif !
Failure to submit a PMN not subject to a TSCA §5(e) or 5(f)
order or exemption when the substance was not distributed
to others or further processed for commercial use by the
company is a level 4 violation, per—day.
Failure to submit a PMN not subject to a TSCA 55(e) or 5(f)
or’der or exemption when the substance was distributed to
others or further processed for commercial use by the com-
pany Is a level 3 violatIon, per—day.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action but was not
either distributed to others or further processed for
commercial use by the companyTs a level 2 vIolation, per-day.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action and the
substance was either distributed to others or fuF Fer
processed by the company is a level 1 violatIon, per—day.
I •7
OOOO

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-9- Anended
Failure tO submit a PMN for a chemical substance which would
reet all requirements for a polyner exemption under 40 CFR
723.250, except that the company did not file for an exemption,
will be assessed as a level i violation, per—day.
Failure to submit a PMN for a themical substance which would
meet all requirements for a polymer exemption under 40 CFR
723.250, except that the company did. not file for an exemption
and the substance was furtner processed for commercial use,
distributed to consumers, or released uncontrolled into the
environment will e assessed as a level 4 violation, per—day.
‘ailure to submit a Notice of Commencement Is a level 3
‘ iolation, one—day.
Failure to submit a timely Notice of Commencement (early or
late submission, up to 30 days prior to manufacture or 30 to
60 days after manufacture) is a level 6 violatIon, one—day.
Failure to submit a timely Notice of Commencement (early or
late submission, more than 30 days prior to manufacture or
‘ more than 60 days after manufacture) Is a level 4 vIolation,
one—day.
Withholding information or submitting false or misleading
information with regard to a PMN, Significant New Use Notice,
or exemption request Is a level 1 vIolation, per—day.
Submission of a false Notice of Commencement Is a level 1
violation, one—day.
Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or
injunctions ana 1gniTiCant New Use (uIes
Violation of on—site restrictions is a level 2 vIolation,
per—day.
Violation of off—site restrictions where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment is a level 1
Violation, per—day.
Failure to submit a Significant New Use Notice when the sub-
stance was ap distributed is a level 2 vIolation, per—day.
Failure to submit a Significant New Use Notice when the sub-
stance was distributed to consumers Is a level 1 violatIon,
per—day.
Violation of production ban or restriction is a level 1.
violation, per—day.
Failure to generate reports as required Is a level 2 violation,
p e r — day.

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-10—
Failure to generate reports as required, where the substance
was either processed by another firm or distributed to
consumers or released uncontrolled into the environment Is
a level 1 VIolation, per—day.
Late submission of required reports where the substance was
not distributed or processed is a level 4 violation, per—day.
Late submission of required reports where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the nvironment Is a level 3
VTolation, per—day.
Withholding Information or submitting false or misleading
information is a level 1 vIolation, per—da)t.
Violation of the recordkeeping provisions where the firm
produces the missing records within 5 days of a written EPA
request is a level 4 violatIon, one—day.
Violation of the recordkeeping provisions where the firm
cannot produce the missing records withIn 5 days of an EPA
request is a level 3 violation, one-day except as specified
on page 26 of the policy.
Commercial Use of a Substance Produced Without a PMN or Valid
Exemption
Commercial use violations will be charged In two circumstances:
1. Where a company processes or uses a chemical substance which
it did not manufacture and it has reason to know Is not on
the Inventory.
2. Where a chemical substance was manufactured or Imported ille-
gally on just a few occasions and processed over a long per-
iod of time, the substance would have been subject to a TSCA
§5(e) or 5(f) order, and the activity could have caused
substantial endangerment to health or the environment.
Commercial us. violations will be assessed as follows:
Violation where the substance was not processed by or dis-
tributed to others after rece1pt bTthe user Is a level 4
violation, per—day.
Violation where the substance was further processed by or
distributed to others is a level 3 vIolation, per—day.
Violation where the substance is or would have been the subject
of a TSCA §5(e) or 5(f) actIon but was not processed by or
distributed to others is a level 2 T lTiTon, per—day.
000035

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—11—
Violation where the substance Is or would have been the subject
of a ISCA 55(e) or 5(f) action and was either processed by
others or released uncontrolled lntrThe environment is a
level 1 violation, per—day.
In cases involving Imminent hazard the Agency reserves the right
to charge a manufacturer with both- failure to submit a PMN and
illegal commercial use of the substance.
Noncompliance with Test Marketing Exemption Restricttons
Overproduction by 10% or less is a level 3 violation, per—day.
Overproduction of more- than 10% would be charged as a failure
to submit a PMN.
Violation of exposure related, on—site restrictions is a
level 2 violation, per—day.
Violation of recordkeeplng provisions Is a level 4 violatIon,
one—day except as specified on page 26 of the policy.
Violations of the off—site control provlsio’ns of a TIlE where
the substance was either distributed to consumers or was
released uncontrolled into the environment Is a level 1
violation, per—day.
Noncompliance with Research and Development Exemption Restrictions
Violations regarding the labeling of the R&D substance where
the substance was further processed by another firm is a
level 2 vIolation, per—day.
Violations regarding the labeling of the R&D substance where
the substance was either distributed to consumers or was
released uncontrolled into the environment Is a level 1
violation, per—day.
Please note that any violation of an R&D exemption other
than failure to adequately label the R&D substance, would
cause the charge to be a failure to submit a PMN.
Noncompliance with Low Volume Exemption Restrictions
Violations regarding the notification of customers of the re-
strictions on use of the substance Is a level 2 vIolation,
per—day.
Violations regarding the failure to notify EPA of any changes
In site or use of the exempted chemical Is a level 2 viola-
tion, per—day.

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—12—
Violations of the recordkeeping provisions of the low volume
exemption Is a level 3 violation, one—day except as specified
on page 26 of the policy.
Vlo}ations of the 1,000 kg. production limit would be viewed
as a failure to submit a PMN.
Violations regarding the failure to maintain required exposure
controls Is a level 2.vlolatlon, per—day.
Noncompliance with the Instant Photographic and Peel—Apart
Film Article Exemption Restrictions
Failure to limit manufacturing and processing to site(s)
listed In the exemption application is a level 5 violation,
per—day.
Distribution in commerce oruse of a peel—apart film article
containing a new chemical substance prior to Its being cleared
through the PMN process would be considered a failure to
submit a PMN and subject to the penalties thereunder.
Failure to follow the conditions of manufacture for instant
photographic or peel—apart film articles where the substance
would not have been subject to a TSCA §5(e) or 5(f) order is
a level 2 violatIon, per—day.
Failure to follow the conditions of manufacture for Instant
photographic or peel—apart film articles where the substance
would have been subject to a ISCA §5(e) or 5(f) order is a
level 1 violation, per—day.
Violation of the recordkeep lng provisions of this exemption
Is a level 3 vIolation, one—day except as specified on page
26 of the policy.
Noncompliance with Polymer Exemption Restrictions
Violations regarding the submission of test data with the
exemption application is a level 1 vIolation, per—day.
Violations of the recordkeeplng provisions of the polymer
exemption Is a level 4 violation, one—day.
All other violations of the polymer exemption would be
charged as a failure to submit a PMN.
Product Ion
Production of a chemical substance not subject to a TSCA §5(e)
or 5(f) order or exemption after submission of a PMN but
prior to the expiration of the PMN review period is a level
3 violation, per—day.
000037

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—13—
Production of a chemical substance after submission of a PMN
but prior to the expiration of the PMN review period when
the substance becomes or would have been the subject of a
TSCA 55(e) or 5(f) actIon or the substance was distributed to
consumers is a level 2 violTtlon, per—day.
Production of a chemical substance prior to the expiration of
the PMN review period when the substance becomes or would have
been the subject of a TSCA 55(e) or 5(f) action and the substance
was distributed to consumers Is a level 1 violation, per—day.
Other Violations
Any other violation not listed above isa level 4 vIolation,
per-day.
Extent
The third step in selecting the base penalty for a spe-
cific violation from the matrix Is to determine the violation’s
position on the extent axis. Extent is based on the amount of
substance Involved in the violation and the nature of the
violation. The following table Is to be used to determine
the extent of a violation.
EXTENT MATRIX
Nature
Extent Level
A
B
C
Major
Significant
Minor
Chemical
>2,500 lbs
>250 lbs to 2,500
lbs
>0
to 250 lbs
Control
‘1,134 kg
‘113.4 kg to 1,134
kg
>0
to 113.4 kg
Control—
>10,000 lbs
>1,000 lbs to 10,000
lbs
‘0
to 1,000 lbs
Associated
>4,536 kg
>453.6 kg to 4,536
kg
>0
to 453.6 kg
Data—
Gathering
.
Hazard
>7,500 lbs
>750 lbs to 7,500
lbs
>0
to 750 lbs
Assessment
>3,402 kg
>340.2 kg to 3,402
kg
>0
to 340.2 kg
* Note exceptions listed on page 14 and 15 under Notes for
determining extent.

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-14—
Notes for determining _ extent
1) ProductIon records will generally serve as the extent
basis in the following violation categories:
• All fail ures to notify EPA when such noti ficatlon
Is required by law.
• Noncompliance with TSCA §5(e) or 5(f) orders,
rules, or injunctions.
• Noncompliance with exemptions under 40 CFR Parts
720 and 723.
I
cbealses S d t he. ma us-ted. 1 f
t ha 1 r mJ ovi d a-wh1 N can e t’o dete m1 ne j
thé e xtent. If the underlying viäiatlve conduct iés
nót relate to production, another more appropriate
basis should be employed to determine extent. If, for
example, the violator disposes of 5,000 pounds of the
substance in violation of the terms of a TSCA §5(e)
order, then the amount of the substance disposed,
as evidenced in disposal records,ls the basis of
the penalty.
2) The b’as ir’ä/ exter in a commercial , (se vioia?iion wi4
be the amouht of t4legally produced.lsubstance’ process ed
or/used by the v1ó Iator on a given day.
3) If the records specified above are unavailable, the
penalty is to be assessed from those records that are
available If possible or at the major extent level.
4) ViolatIons for withholding information, submitting false
or misleading Information, or failure to submit reports
required by a TSCA §5(e) or 5(f) order, rule or Injunc-
tion do not lend themselves to extent determinations
based on production amounts. For the purposes of de-
termining per—day penalties under this ERP, if the
the study which Is the subject of the violation in-
volved human monitoring data, the extent Is major.
If tha study which is the subject of the violation
involved animal laboratory data, the extent Is
significant. If the study involved physical or
chemical properties or environmental fate data, the
extent is minor. This Is consistent with the TSCA
§S8, 12, and 13 Enforcement Response Policy.
5) ViolatIons involving genetically engineered microor-
ganisms do not lend themselves to extent determinations
based on the matrix, due to the extremely small amounts
involved. These microorganisms may have the ability to
reproduce, creating a larger environmental hazard.
000039

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—15—
Therefore, any violation Involving a genetically
engineered microorganism will be considered major
in extent. Likewise, violations Involving any genetic-
ally altered or naturally occurring organisms subject
to a SNUR or TSCA 55(e) order will be considered major
tn extent. In the event the Agency identifies low—risk
categories of organisms, violations involving low—risk
organisms will be considered significant.
6) All Notice of Commencement violations will be considered
major in extent.
Gravity
Gravity, as used in th1 s UP, is dependent upon the nature,
extent and circumstances of the violation.
Per—Day Assessments
Where per—day assessments are provided for In the Circum-
stances Level section, the base penalty is calculated for the
first occurrence of a violative activity and assessed for each ddy
of subsequent occurrence. For example, a manufacturer or importer
is responsible for notifying EPA prior to iroduct1on or import-
ation of a new chemical substance. Each day of production or
importation of a new chemical substance In violation of the
notification requirements of TSCA $5 constitutes a new viola-
tion. A day of violation is counted for each day a chemical
substance is produced regardless of the number of batches pro-
duced on a given day. The total amount produced on a given day
would be used when determining extent. If production of a chemi-
cal substance takes place over a number of days before the
manufacturing process Is complete, production occurs only when
the manufacturing process has been completed. Likewise, a manu-
facturer or importer subject to an order, rule or injunction
under TSCA $5 which directs him to dispose of the substance or
wastes in a particular manner, is in violation for each day dis—
posal occurred contrary to the requirements of the order, rule or
injunction. Illegal commercial use violations are assessed under
the same principles. Commercial use violations, however, are
based on the amount of Illegally produced chemical substance used.
Per—day penalties assessed on a daily basis (I.e., calendar
days vs. days of actual production) are generally reserved for
violations of the data—gathering provisions of,TSCA 55 where
the Agency needs the data to assess the risks presented by a
chemical substance, or situations involving Imminent hazard.
One—Day Violations
Violations of the recordkeeping provisions of TSCA 55 are
assessed on a one—time basis only except where compliance cannot
be determined or noncompliance was intentional. See pages 22
and 26 for a further discussion of these issues.

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—16—
Imminent Hazard
Upon review of the facts surrounding a violation, the
Agency may make a finding that continued production, sale and
distribution of a substance may present an imminent haz&rd to
health and the environment. In the event of such a finding,
the Agency may take steps to halt further production, sale and
distribution of the product as well as assess the maximum pen-
alty of $25,000 per day for each calendar day the exposure from
manufacturing and/or commercial use occurred. Thus, if the
Agency determined that exposure to a substance found to be an
imminent hazard occurred for 90 days, the penalty would be
90 X $25,000 or $2,250,000.
Gravity Based Penalty
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent ot each violation, is to be determined
by using the following matrix:
GRAVITY
BASED PENALTY
MATRIX
Circumstances
Extent
A
B
C
Major
Significant
Minor
Level
S
1
High Range
2
$25,000
$20,000
$17,000
$13,000
$5,000
$3,000
3
Mid Range
4
$15,000
$10,000
$10,000
$ 6.000
$1,500
$1,000
5
Low Range
6
$ 5,000
$ 2,000
$ 3,000
$ 1,300
$500
$200
Whether a penalty is to be assessed as a one—day assessment
pr as a continuing violation on a per—day basis is addressed in
the Circumstances section and on page 15.
000041’

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-17 •
Adjusting the Gravity Based Penalty
Follow the adjustment factor application instructions as
presented in the general TSCA penalty policy document, “TSCA
Civil Penalty System of September 10, 1980 at pages 9—16.
Adjustment factors specific to this policy are discussed
below.
Other Factors As Justice May Require
Voluntary Disclosure
Penalty amounts for violations of TSCA 55 will be reduced
when the violations are voluntarily disclosed by the company.
For TSCA 55 violatIons the penalty reductions for voluntary
disclosure are as follows.
Voluntary disclosure . .. ......... ......... .25%
Immediate disclosure within
30 days of discovery.. .. ...... ... ....... .25%
Takes all steps reasonably
expected . ....... ..... . .......... .u to 15%
Total......up 0
or. vol e
.The Civil
p.&niflj_an .the. reason for he reduction.
—
The Agency wants to encourage voluntary disclosures for
TSCA §5 vIolations. In order to do this, an automatic penalty
reduction may be made. To be eligible, a firm must make the
disclosure prior to being notified of a pending inspection
and the disclosure cannot be one that Is required by TSCA
58(e) or that Is made after EPA has received information
relating to the alleged violation. Voluntary disclosure of
a violation will result In a 25% reduction of the penalty.
In some cases, companies have delayed 9—12 months In re-
porting a violation. An additional 25% penalty reduction may
be given to those companies which report the potential violation
to EPA within 30 days of having reason to believe that they may
be In violation. This reduction is also applicable to firms
which have changed ownership.
If a company realizes it cannot find a chemical which It
is manufacturing on the non—CBI Inventory, and for which ft did
not submit a PMN, it has reason to believe that ft may be In
violation. The time limit begins the moment the company has
reason to believe that the chemical may not be on the Inventory,
not after EPA has confirmed the Inventory status of the chemical.

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—18—
*Vfrimental1ybeieficiaT expendjtut’es above and beyoi d
those ip Cif1celiy required under TSCA are allowabl4 T penalty
reductions at the Agency’s discretion. Generally, environ-
mentally beneficial expenditures may be deducted from the
penalty at the Agency’s discretion fn accordance with the
TSCA Clvii Penalty Policy for recall costs and special dis-
posal costs. If such action Is requested by EPA or ündet’taken
by the company independently, but not required by ISCA, a
regulation, order, or TSCA 557 or 17 and such action is
conducted in a manner satisfactory to EPA.
As an alternative to the deduction of costs for environ-
mentally beneficial expenditures, a penalty reduction of upto
15% may be eade foi v0 iuntari1ydisc1oséd 1o1at1ons at the
Agency-’s dfscretlOn if the company takes aU steps reasóirably’
expectEdfrequestdby EPA to mitigate-the v1of.t1on -This- ‘
includes timely sUbrnf ssion of information necéssavy for EPA
to assess a violation. Timely submission means within 30 days
or a time period agreed upon by EPA and the company. This
reduction is not in addition to reductions for environmental
expenditures above and beyond that required by the law, but
Is an alternative. Thfs reduction of ii to-15%tr *Vy p UI-
cable to companies Wh1cb haveYoliantarlTy disclosed the
violation and may b.tak n In addition to the Attitude f’the
Violator adjustment found In the TSCA Civil Penalty Poltcy;
If the steps expected/requested by EPA have not been taken
at the time of sett1emen this section does not apply.
Future activities maybi addressed in accordance with the
Settlement with Conditions Policy.
In some cases, mitigation may not be possible. For example,
if the product was distr-ibuted-in commerce and has already been
used, there may bE nothing the company can do to rectify the
situation. In these cases, no reduction will be given under
this heading. In other cases, if no steps are expected because
cessation of the violative action Is sufficient, i.e., the
chemical clears the PMN process and OTS makes a finding that
no corrective actions are necessary, EPA may still give the
added 15% reduction for companies that have voluntarily
disclosed the violation, provided the penalty exceeds any
economic benefit gained by the company.
An example of a situation in which EPA may give the addi-
tional 152 reduction is one in which a company manufactures
a chemical not on the Inventory and does not file a PMN. The
company notifies EPA of the possible violation, immediately
ceases all manufacture, processing, and distribution until
It files a PMN and the chemical clears the reviàw period
without being a candidate for a TSCA 55(e) or 5(f) actIon.
000043

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—19—
Economic Benefit
In no cases shall reductions be given if the reduced
penalty does not exceed the economic benefit gained from non-
compliance. EPA should require the company to present infor-
mation concerning economic benefit.s gained from the violative
action prior to the reduction of the penalty except for the
25%/50% off far voluntary disclosure. In all cases, EPA wishes
to encourage voluntary disclosure.
Attitude
The existing adjustment provision for the Attitude of
the Violator in the TSCA Civil Penalty Policy (Septemeber 10,
1980) may also be applied to adjust the penalty by up to 15$.
Please note that this d.justtv nt may decrease or increase the
P! L b zJ5%.
t hä-t oi I y aM-ôTrs--1n d--t
A company would generally qualify for a downward adjustment
If it Immediately halts the violative activity, takes steps
to rectify the situation and there Is no finding of culpa-
bility. However, such a reduction is at the discretion of
EPA.
History of Prior Violation
The Agency will disregard the firm’s prior history of
violations In calculating the penalty for a self—disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as Indi-
cated in the TSCA Civil Penalty Policy, even If the prior
history results from a violation which was voluntarily
disclosed.
Culpability
n9
wherL.a vJ tr daes, have c o
impo tft c hem1cal
subitance fro. a foreign manufacturer where the foreign manu-
facturer falsely certifies that the substance is on the TSCA
Inventory and the company importing the substance only knows
the trade name of the substance. The importing company must
be able to provide a copy of the written false certification
and show that they were unable to ascertain the Identity of
Agency can reduce the
In the event of
fii ther violations of this type, history of prior violation
would not be considered when determining the penalty.

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—20—
Explanation of the Penalty Policy
Nature
The nature of a TSCA §5 violation depends on whether the
violation deals with chemical control, control—associated
data—gathering, or hazard assessment.
1. Chemical control regulations are aimed at minimizing
the risk presented by a chemical substance by
placing constraints on how the substance Is handled.
Section 5(a)(2) authorizes the Administrator to make
a determination that use of a hemica1 is a signifi-
cant new use and require the manufacturer or importer
to notify EPA prior to Initiating such a use.
Sections 5(e) and 5(f) authorize a wide variety of
chemical control requirements from labeling restric-
tions to manufacturing bans. Section 5(h)(1) author-
izes the Administrator to Impose restrictions upon
the manufacture or processing of a test marketed
substance. Violations of those restrictions that
place constraints on how a substance Is handled fall
into this category. Section 5(h)(3) obligates a
firm producing a substance under a research and de-
velopment exemption to give adequate warning to
emp’oyees If that substance Is dangerous. This is
also a constraint on a substance’s handling and is
included in this category.
2. Control—assocIated data—gathering requirements are
the recordkeeping and/or reporting requirements
associated with a chemical control regulation.
These requirements enable the Agency to evaluate the
effectiveness of the regulation and to monitor
compliance. Some requirements in ISCA §5(e) and 5(f)
orders, rules, or injunctions would fall Into this
category (i.e., a section 5(e) order that requires the
manufacturer to keep records of all purchases of the
regulated substance). Some test marketing exemption
restrictions would also fall into this category as
section 5(h)(1)(B) authorizes the Administrator to
impose, among other things, recordkeeping and/or
reporting requirements.
3. Hazard assessment requirements are used to develop
and gather information necessary to weigh the risks
and benefits presented by particular chemical sub-
stances and to impose chemical control requirements
when appropriate. This category includes violations
for failure to notify, withholding information from
EPA or submission of false or misleading information.
000045

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—21—
Circumstances
Circumstances are used in the penalty policy to determine
the probability of potential harm. In other words, a variety
of facts surrounding the violation as it occurred are examined
to determine whether the circumstances of the violation are
such that there is a high, medium, or low potential for harm.
To calculate the penalty first use the nature determination
list to select the appropriate nature category and then
select the appropriate circumstance.
Application of the Circumstances Factor to Section 5
1) Chemical control . Chemical control violations in-
clude noncompliance with ISCA 55(s) or 5(f) actIons,
failure to submit a significant new use notice,
noncompliance with, a research and development exemp-
tion restriction on adequate warning, noncompliance
with test marketing exemption restrictions on the
actual control of the substance, improper commercial
use of a substance produced in violation of a ISCA
§5(e) or 5(f) order, or noncompliance with any ex-
emption restriction on the use of _a substance found
under 40 CFR Part 723. For these violations, the
initial circumstance level is based on the severity
of the violation. Circumstance evaluations are
adjusted by the degree of potential environmental
exposure and potential risk posed by the chemical.
2) Control—associ ated data—gathering . Control—associ—
ited data—gathering violations include noncompliance
with the recordkeeping provisions of TSCA §5(e) or
5(f) actIons and exemption restrictions under 40 CFR
Parts 720 and 723. For these violations the circum-
stances are dependent on the extent to which the
Agency’s ability to monitor and/or evaluate the
risks posed by the substance or the company’s com-
pliance with the substantive legal requirements is
Impaired.
3) Hazard assessment . Hazard assessment violations
Include failure to submit a premanufacturing noti-
fication and associated commercial use, failure to
submit a notice of commencement, withholding Infor-
mation, submitting false or misleading Information,
and noncompliance with the reporting provisions of
ISCA §5(e) or 5(f) actions.

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-22—
When determining whether a PMN Is subject to a TSCA §5(e)
or 5-(f) action, there are instances where rather than Imposing
controls under a ISCA §5(e) order with testing triggered at a
particular production volume or time, EPA requires testing
upfront before manufacture may commence. If the company
refused to either do he testing or withdraw the PMN, EPA
would then unilaterally issue an “adversarial’ TSCA §5(e)
order prohibiting any manufacture. This type of case would
be treated as a TSCA §5(e) or 5(f) action and subject to
higher penalties.
When determining the circumstance level for recordkeeping
violations when EPA has requested the missing records, EPA
must be able to determine compliance from the records which
are provided or the charge would be considered failure to
produce the missing records Where records are necessary to
determine compliance with a requirement of a TSCA §5 action,
rule, or injunction and the records cannot be produced, EPA
reserves the right to charge per day penalties.
PMN violations involving chemical substances which meet
all requirements for a polymer exemption under 40 CFR 723.250,
except the company did not file for an exeuwptlon, will be
assessed at a level 5 cIrcumstance. EPA has determined that
chemicals which qualify for these exemptions are of less
concern as a hazard.
Extent
Extent is used to take Into consideration the degree,
range, or scope of the violation. The.ixte,tt. Matrix (pg. 13)
provides for thre.e.J_evels of extent: M j9r :Stgn1-fi-cEnt- and-
M i nor. i t it. aii” Irege
of u t n II d thè v 1 o lit fve conduct .
Production records will generally serve as the penalty
ba.sls In the following violation categories:

• Noncompliance with TSCA 55(e) or 5(f) orders, rules,
or Injunctions and significant new use rules (except
for reporting violations).
• Noncompliance with test marketing or research and
development exemption restrictions.
Noncompliance with exemption restrictions under 40
CFR Parts 720 and 723.
000047

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—23—
If a chemical substance is manufactured for commercial
purposes as part of a chemical mixture, the amount of the
chemical substance from which the mixture is made Is used to
calculate the penalty. If a chemical mixture made from a
chemical substance is Incorporated Into an article, the
penalty Is calculated from the amount of the chemical sub-
stance used to manufacture the chemical mixture. If the
amount of chemical substance used to manufacture the chemical
mixture is unknown, the amount of chemical mixture will be
used to determine extent. If a portion of a batch containing
an illegally manufactured chemical substance is sold/distri-
buted for commercial purposes, the entire batch is considered
to be manufactured for commercial purpo es and the amount
of the chemical substance used to manufacture the entire
batch Is used to calculate the penalty. Likewise, if one
batch of an illegally manufactured chemical substance is
sold/distributed for commercial purposes, all other batches
of the chemical substance are considered to be manufactured
for commercial purposes.
If a firm disposes of a substance In violation of a test
marketing restriction or a section 5(e) InjunctIon, then the
amount ii legally disposed Is the basis of the penalty.
Violations involving genetically altered, naturally oc-
curring or genetically engineered microorganisms will all be
placed In the major extent category due to the Agency’s
general level of concern over the potential for harm from
unregulated environmental release. In the event the Agency
identifies low risk categories of organisms, violations in-
volving low risk organisms will be placed In the significant
extent level.
It should be noted that if those records specified above
are unavailable, the penalty should be assessed on those
records that are available or where there are no records,
assume the violation Is major In extent.
Determining extent for violations involving withholding
information, submitting false or misleading Information, or
failure to generate reports as required by a ISCA 55(e) or 5(f)
action requires different criteria. These violations are
assessed for each day the violation occurred beginning from
the day the information was submitted or should have been
submitted. While the amount of a substance produced has
an effect on the potential exposure of the public or environ-
ment to that substance, the harm is caused by the failure to
submit the data or submit true and complete data. Consistent
with the TSCA 558, 12 and 13 Enforcement Response Policy,
extent Is determined by the type of data involved in the
violation. If the subject study involves laboratory animal
data, the extent is determined to be significant. If the
subject study involves physical/chemical properties or
environmental fate data, the extent level is minor.

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-24-
The three levels of extent (major, significant and minor)
are based on the potential for harm to health or the environ-
ment. As stated previously, chemical control violations are
considered the most serious due to the fact that risks have
largely been identified and steps have been taken to mitigate
those risks. Thus, the amount of production/disposal necessary
to place a violation into the major and significant categories
Is substantially less than the amounts which place a violation
into those same categories for hazard assessment violations or
control—associated data—gathering violations. Hazard assessment
violations impair the Agency’s ability to determine the risks
presented by a particular new chemical substance and impose
control requirements. Because the Agency has no way of knowing
whether the substance presents a risk to health or the envi-
ronment, hazard assessment violations ire placed between chem-
ical control violations and control—associated data—gathering
violations in terms of the .amount of substance necessary to
place a violation in the various extent levels. Control-asso-
ciated data—gathering violations impair the Agency’s mission
to mltgate threats to health and and the environment the
least. These violations involve the recordkeeping provisions
of a ISCA §5 action. Nonetheless, they are Important for
the Agency to assure compliance.
Application of the Extent Factor to Section 5
1) ChemIcal control violations . The Agency will have
either knowledge or concerns that the substance may
be harmful. Thus the potential for harm is greatest
in this category. An amount of a substance that
is considered minor or significant in the two other
categories may be considered major here. A minor
designation covers amounts from 0 to 250 lbs. (0 to
113.4 kg.); a significant designation covers amounts
greater than 250 lbs. to 2,500 lbs. (113.4 kg. to
1,134 kg.); the major designation is assigned to
amounts greater than 2,500 lbs. (1,134 kg.).
2) Control—assocIated data—gathering . Since
production, distribution, etc. is always allowed,
the penalties escalate more slowly than for the
chemical control category violations: minor is 0 to
1,000 lbs. (0 to 453.6 kg.); significant is greater
than 1,000 lbs. to 10,000 lbs. (453.6 kg. to 4,536
kg.); major is greater than 10,000 lbs. (4,536 kg.).
3) Hazard assessment . iii this category, the Agency can
neither assume that the substance is harmless nor
harmful. The violations, however, are more serious
than those in the control—associated data—gathering
category: minor is 0 to 750 lbs. (0 to 340.2 kg.);
significant Is greater than 750 lbs. to 7,500 lbs.
(340.2 kg. to 3,402 kg.); and major is greater
than 7,500 lbs. (3,402 kg.).

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—25—
Gravity of the Violation
Gravity refers to the overall seriousness of the violation.
As used in this penalty system, gravity is a dependent variable
(I.e., the evaluation of nature, extent, and circumstances will
yield a dollar figure in the matrix that is the gravity based
penalty).
Imminent Hazard
Imminent hazard violations require the Agency to make a
finding that a particular violative substance presents an im-
minent hazard to health or the environment. Penalties for
violations Involving imminent hazards are assessed for each
day the violation continues at the maxlmumpenalty allowable
when a company manufactures and uses the hazardous chemical.
In these cases separate charges, one for manufacturing and
one for commercial use may •be assessed.
Per—Day Penalties or One—Day Assessments
TSCA 516(a)(1) provides not only that civil penalties may
be assessed up to $25,000 but that each day a violation con-
tinues is a separate violation for which penalties may be
assessed. For the purposes of this ERP, per—day penalties will
be assessed for each day a violation of ISCA 55 occurs. If,
for example, a firm is charged with the illegal manufacture of a
chemical substance, each separate day of manufacture constitutes
a violation regardless of the number of batches produced during
that day. The total amount produced In a day would be used as
the basis for the extent of the violation if a company has more
than one facility illegally producing a substance on a given
day. Likewise, if a firm illegally disposed of a substance, the
penalty is based on the number of days the disposal occurred
regardless of the number of shipments for disposal on a given
day. The total amount of a substance produced or disposed of
on a given day Is used when determining extent. Where the
manufacture or processing of a substance takes several days
to complete, the penalty Is based only on the day the manufac-
turing or processing was completed. For example, If it takes
3 days to manufacture a substance In violation of TSCA 55,
the penalty would be assessed for the day the manufacture of
the substance was completed (day 3).

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—26—
Violations which warrant daily penalties are those which
Impair the Agency’s ability to assess the risks to public
health or the environment. These penalties are assessed from
the date of occurrence to the date of discovery.
Per—day penalties will be assessed for the following viola-
tions: -
• Withholding information or submitting false or mislead-
ing Information
• Failure to generate reports as required by a TSCA §5(e)
or 5(f) action
• Noncompliance with TSCA §5(e) and •5(f) orders,
rules, and injunctions (chemical control aspects)
• Noncompliance with, research and development exemption
restrictions (violation of adequate warning and ex-
pert supervi sion requirements)
• Commercial use of an illegally produced substance
• Noncompliance with exemption restr9ctlons under 40
CFR Parts 720 and 723 (chemIcal control aspects)
• Failure to notify
Peni1 t4e 5’ fo’r •d16épngvi ol atl 0 ns wtU be as ses ’sed
on 7 ‘a .on e -t I ITfe..
ally ‘pose asLg eattc a ri-sk ’to public health, or the- enY1 ronm’ë nt.
Th”e .v4o-la-t;io . ns: a’ri se fro,w a:s1ngle violative act .
One—day penalties will be assessed for the following
violations:
• Noncompliance with section 5(e) and 5(f) orders,
rules, and injunctions recordkeeplng provisions only.
The Agency reserves the right to assess per day pen-
alties for recordkeeplng violations when compliance
wltb a requirement of a TSCA §5 actIon, rule or
Injunction cannot be verified.
• Noncompliance with exemption restrictions under 40
CFR Parts 720 and 723 involving recordkeeping
provi slons.
• Not. lce o ECommencement-.v1olations.. The Agency re-
serves the right to charge a pir day violation
in those cases where the notice was intentionally
withheld by the company.
00005!

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-27—
Multiple VlolationslCheinlcaIs
Multiple violations of a ISCA §5 action, rule, or injunc-
tion will be assessed separately for each distinct violation.
Where more than one chemical substance Is in violation, penal-
ties will be assessed for each violative chemical.
Adjustment Factors
Voluntary Disclosure
This Is an activity which the Office of Compliance Mont—
toring (0CM) wants to encourage. If EPA receives a voluntary
disclosure, the Agency can proceed with action to rectify a
situation even if the manufacturer is reluctant. Actions by
EPA to convince a violator to do the right thing may Include
penalties Issued on a per—day basis, ISCA Ui or 17 actIons,
or other additional rule—making.
Although 0CM considered Including the condition that the
manufacturer acted in good faith prior to the violation and that t
he ceased the violative act as soon as he had reason to know of
the violation, 0CM decided not to Include this as a condition for
the 25$ reduction for the following reasons: 1) If the violation
continues, EPA may assess penalties against the manufacturer for
each day of violation. 2) In calculating the penalties for yb—
lations after the violator knew of the violation, a culpability
factor for those days may be added. 3) If the violator intended
to violate TSCA prior to disclosing the violation, the penalties
for the entire period of violation may be increased based on a
culpability findIng. 4) If the violator does not act to rectify
the situation, his penalties may be Increased based on attitude
if no finding of culpability Is made. 5) IrrespectIve of the
circumstances of the violation, the Agency wants the manufacturer
to report it.
Immediate Voluntary Disclosure
0CM wants to further encourage prompt reporting. There-
fore, an added incentive is provided so that the Agency is
notified soon after the manufacturer has reason to know of a
potential violation.
History of Noncompliance
As a further incentive for the voluntary disclosure of
violations, the Agency has decided to forego the Imposition of
penalty Increases for a history of noncompliance in assessing
penalties for voluntarily disclosed violations.
However, a voluntarily disclosed violation does constitute
a violation and is to be used to increase penalties for future
violations which the Agency discovers.

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Definitions
Consumer — Any person who uses a chemical substance for any
purpose.
Off—site Restrictions— Off—site restrictions are those re-
strictions placed on a substance after It leaves the original
site of manufacture or processing.
On—site Restrictions — On—site restrictions are those restric-
tions imposed upon a Company by EPA through a TSCA $5 action,
rule, or Injunction at the site of manufacture or processing.
IP kiepni dZe efrVtv -
r;equi r e’s tfrC ñi á táWñ tf9fs fsé s a
t O uWne St.
Reports — Reports are those data the Agency Is requiring the
Company to submit to EPA under TSCA §5.
000053

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APPENDIX 1
EXAMPLES
Failure to Notify
Exa’ne 1 -
A company has produced a chemical substance, which is not on
ttue Inventory for 5 years, with production occurring on 50
days each year, and 1,000 pounds of the substance produced
on each day of production. The chemical substance Is consumed
in another chemical reaction. The company stops production
Immediately up ; discovery of the violatlon•, voluntarily
discloses the violation within 30 days, submits a PMN within
30 days and takes all the steps EPA requests of them. The
PMN goes through review without any health or environmental
concerns being raised. The company Is charged with a failure
to submit a PMN, level 4, significant, per-day.
$6,000 X 5 X 50 ‘ $1,500,000
80$ reduction in penalty warranted — $1,200,000
Final Pen ’ty — $300,000
Example 2
A company has produced a chemical substance, which is not on
the Inventory, for 4 years with production occurring 50 days
per year, and 8,000 pounds of the substance produced on each
day of production. The chemical substance is further processed
by the company on 100 days per year, 4,000 pounds processed
on each day and sold In an end—use product. The company
discovers the violation, immediately stops production, volun-
tarily discloses the violation within 30 days, submits a PMM
within 30 days and takes all steps EPA asks of them. The
PMN review identifies a substantial environmental concern
and the company subsequently enters into a TSCA 55(e) consent
order to address this concern. The company Is charged with
a failure to submit a PMN, level 1, major, per—day.
4 X 50 X $25,000 • $5,000,000
80% reduction In penalty warranted — $4,000,000
Final Penalty — $1,000,000

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Example 3
pany has produced a chemical substance, which is not on
nventory, for 8 years, with production taking place 25
, a year, and- 3,000 pounds of the substance produced on
ch day of production. The chemical substance is incorpor-
ated into a product which is sold to its customers for use
in a consumer p’-’rtuct. The company discovers the violation
and reports it -. EPA 75 days later, after it has developed a
legal substitute for the illegal chemical substance and has
been notified of a pending inspection. A PIN is not filed
as the company has no intention of making the illegally pro-
duced substance again. The company produces production
records for the substance only after missing two deadlines
for submitting the records. The company is charged with
a failure to submit a PMN, level 3, signifIcant, per—day.
$10,000 X 8 X 25 = $2,000,000
15% penalty adjustment upward for-attitude - $300,000
Final Penalty — $2,300,000
Example 4
A company failed to submit a Notice of Commencement to EPA.
The first day of production yielded 3,000 pounds of the
bstance. EPA discovered the violation. The company is
arged with a failure to submit a Notice of Commencement,
Jevel 3, -‘g”ifitai , one—day.
The sif,ooo.
Example 5
A company produced a chemical substance regulated by a SNUR,
for a significant new use as defined by the SNUR, without
submitting a Significant New Use Notice to EPA. The sub-
stance was incorporated into a consumer use product. The
company produced the chemical 9 times, with 3,000 pounds
produced on each occasion. EPA discovered the violation.
The company Is charged with a failure to submit a Significant
New Use Notice, level 1, major, per—day.
9 x $25,000 = $225,000
000055

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—2—
Example 3
A company has produced a chemical substance, which is not on
the Inventory, for 8 years, with production taking place 25
days a year, and 3,000 pounds of the substance produced on
each day of production. The chemical substance Is Incorpor-
ated into a product which is sold to Its customers for use
In a consumer product. The company discovers the violation
and reports it to EPA 75 days later, after It has developed a
legal substitute for the illegal chemical substance and has
been notified of a pending Inspection. A PMN Is not filed
as the company has no intention of making the Illegally pro-
duced substance again. The company produces production
records for the substance only after missing two deadlines
for submitting the records. The company is charged with
a failure to submit a PMN, level 3, sIgnificant, per—day.
$10,000 X 8 X 25 $2,000,000
15% penalty adjustment upward for attitude — $300,000
Final Penalty — $2,300,000
Example 4
A company failed to submit a Notice of Commencement to EPA.
The first day of production yielded 3,000 pounds of the
substance. EPA discovered the violation. The company Is
charged with a failure to submit a Notice of Commencement,
level 3, significant, one—day.
The company would be charged $10,000.
Example 5
A company produced a chemical substance regulated by a SNUR,
for a significant new use as defined by the SNUR, without
submitting a Significant New Use Notice to EPA. The sub-
stance was Incorporated into a consumer use product. The
company prodiced the chemical 9 times, with 3,000 pounds
produced o i each occasion. EPA discovered the violation.
The company (s charged with a failure to submit a Significant
New Use Notice, level 1, major, per—day.
9 x $25,000 $225,000

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—3—
Example 6
An cnspector discovers a study that should have been submitted
In conjunction with a PMN application. The study Involved ani-
mal testing data. The chemical substance was produced for 1 year
before the violation was detected. The company is charged with
witholding Information, level I, significant, per—day.
$17,000 X 365 $6,205,000
Example 7
A company produces a chemical substance’under a TSCA S5(e)
order. The order requires the company to train workers and
requires the employees to wear respirators while engaged in the
manufacture of the substance. The inspector discovers that the
company has not conducted training as required and that the
workers do not wear respirators, or have them available, while
engaged in the manufacture of the substance. Production has
taken place on 30 days with 5,000 pounds of the substance pro-
duced each day. The company Is charged with two counts, fail-
ure to provide training and failure to require their employees
to wear respirators, level 2, major, per—diy.
$20,000 X 2 X 30 • $1,200,000
Example 8
A company produces a chemical substance under a TSCA S5(e)
order. The order requires the company to Incinerate all
wastes derived from the production of the chemical substance.
An Inspector discovers that the company has. not Incinerated
the wastes as required, but has been releasing the wastes to
water after primary treatment. Disposal took place on 50
days with 2,000 pounds disposed of each day. The company Is
charged with failure to follow the restrictions of the TSCA
§5(e) order regarding disposal, level 1, significant, per—
day.
$20,000 X 50 • $1,000,000
030057

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—4—
Example 9
A company produces a chemical substance under a TSCA §5(e)
order. The order requires the company to either stop pro-
duction or submit a study to EPA after producing 400,000
pounds of the substance. The company submits the study to the
Agency and the_ study is approved. A subsequent Inspection re-
veals that the company had produced 450,000 pounds of the sub-
stance prior to submitting the study, producing 5,000 pounds
of the substance on 10 different days. The company Is charged
with violation of a production ban, major, level 1, per—day.
$25,000 X 10 $250,000
Example 10
A company has manufactured and processed a chemical substance,
which Is not on the Inventory, for 8 years with manufacturing
occurring 100 days each year, 5,000 pounds manufactured each
day and processing occurring 200 days each year, with 2.500
pounds processed each day. The processed chemical substance
is Incorporated into an end use product. An Inspector dis-
covers the violation. A review of the chemical by EPA Iden-
tifies a substantial environmental concern which would have
placed the the substance as TSCA §5(e) order candidate. The
company is charged with a failure to submit a PMN, level 1,,
significant, per—day.
$20,000 X 8 X 100 $16,000,000
Example 11
A company applied for and recleved a low volume exemption for
a chemical substance. An inspector discovers that the company
produced 1500 kg of the substance In 3 different years with
production occurring on 3 days each year, 500 kg produced
each day. The chemical substance would have had a TSCA §5(e)
order Issued If it had not been granted a low volume exemption.
The chemical substance was distributed to customers. The com-
pany would be charged with a failure to file a PMN, level 1,
significant, per—day.
$20,000 X 3 X 3 — $180,000

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—5—
Example 1?
A company produced a chemical substance which is not “n the
Inventory, for 5 years, with production occurring on 50 days,
5,000 pounds produced each day. The chemical substance was
further processed for. 100 days each year with 2,500 pounds of
the substance processed each day. The finished product con-
taining the chemical substance was distributed to consumers.
The chemical substance was a polymer that otherwise would have
qualified for a polymer exemption. The company is charged
with failure to file a PMN, level 5, sIgnificant, per—day.
$3,000 X 5 X 50 $750,000
Example 13
Company A solicited several manufacturers to produce a chemical
substance for them. They were advised by one company that the
substance did not appear on the Inventory and that a PMN would
have to be filed prior to manufacturing. Another company agreed
to produce the chemical for Company A. Company A commercially
used the chemical substance for 5 years, 100 days per year,
processing 3,000 pounds of the substance on each occasion.
EPA discovered the violation at the manufacturing company and
charged the manufacturing company with a failure to file a PMN.
The PMN was filed and no problems were found with the chemical
substance auring the PMM review. A subsequent Inspection of
Company A discovered the letter from the manufacturer who had
advised Company A of the status of the chemical. Company A was
charged with commercial use of an illegally manufactured sub-
stance, level 3, maJor, per—day.
5 X 100 X $15,000 — $7,500,000
000059

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Failure to Notify
VIOLATION
Failure to submit a PMN
order or exemption when
to consumers or further
company.
not subject to a TSCA 55(e) or 5(f)
the substance was not distributed
processed for commercial use by the
Failure to submit a PMN not subject to a TSCA 55(e) or 5(f)
order or exemption when the substance was distributed to
consumers or further processed for commercial use by the com-
pany.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action but was
either distributed to consumers or further processed for
commercial use by the company.
Failure to submit a PNN when the
been the subject of a TSCA §5(e)
substance was either distributed
processed by the company.
substance is or would have
or 5(f) action and the
to consumers or further
Failure to submit a PMN for a chemical substance which would meet
all requirements for a polymer exemption under 40 CFR 723.250,
except that the company did not file for an exemption.
Failure to submit a PMN for a chemical substance which would meet
all requirements for a polymer exemption under 40 CFR 723.250,
except that the company did not file for an exemption and the
substance was further processed for commercial use, distri-
buted to consumers, or released uncontrolled into the envi-
ronment.
Illure to submit a Notice of Commencement.
LEVEL
4
3
2
1
5
4
3
PER—DAY/ NATURE
ONE-DAY
Per—day
Per—day
Per—day
Per—day
Per—day
Per—day
One-day
HA
HA
HA
HA
HA
HA
HA
HA — Hakard Assessment
CC - Chemical Control
CADG - Control-Associated Data—Gathering

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Amended 2
vloLnrIu;1
lure to submit timely tiotice of Commencement (early or
ate submission, up to 30 days prior to manufacture or 30 to
oU days after manufacture).
Failure to subunit a timely Notice of Commencement (early or
late submission, more than 30 days prior to manufacture or
more than 6(1 days after manufacture).
WithholJing information or submitting false or misleading
Information with rejard to a PMI1, Significant New Use
Notice, or ex rnption request.
Submission of a f3ls Hotice of commencement.
Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or
Injunctions and Significant New Use Rules
Violation of on—site restrictions.
Violation of off-site restrictions where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment.
Failure to submit a Significant New Use Notice when the sub-
stance was not distributed.
Failure to submit 3 Significant New Use Notice when the sub-
stance was distributed to consumers.
Violation of production ban or restriction.
LEVEL
.6
4
1
1
2
1
2
1
1
PE R—L)AY/
ONE-)AY
One—day
One-day
Per—day
One—day
Per-day
Per—day
P /day
Per-day
Per-day
Per—dew
HA
HA
HA
HA
cc
cc
cc
cc
cc
—
C)
C)
C)
C)
Failure to generate reports as required.
2
HA

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VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Failure to generate reports as required, where tI ILthstance
was either processed by another firm or distributed to 1 Per-day HA
Consumers or released uncontrolled inE1 the environment.
Late submission of required reports where the substance was
not distributed or processed. 4 Per-day HA
Late submi ssion of required reports where the substance was
either processed by another finn or distributed to consumers 3 Per—day HA
released uncontrolled Into theTnvlronment.
Withholding Information or submitting false or mIsleading 1 Per—day - HA
i nfonna tion.
Violation of the recordkeeping provi sions where the finn
produces the missing records within 5 days of an EPA request. 4 One—day CADG
Violation of the recordkeeping provisions where the firm
cannot produce the ml ssing records wi thin 5 days of an EPA 3 One-day CAI)G
request except as specified on page 26 of the policy.
Coamiercial Use of an Illegally Produced Substance
Commercial use violations will be charged In three circumstances:
1. When a company processes or uses a chemical substance which
It did not manufacture and it has reason to know Is not on
the Inventory.
2. When a chemical substance was manufactured or Imported ille—
gaily on just a few occasions and processed over a long per-
iod of time, th substance would have been subject to a TSCA
S5(e) or 5(1) order, and the activity could have caused
substantial endangerment to health or the environment.

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VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Commercial use violations will be assessed as fbi-lOws:
Violation where the substance was not processed by or dls— 4 Per—day CC
tributed to others after recef rbTthe user.
Violation where the substance was further processed by or 3 Per—day CC
distributed to others.
Violation where the substance Is or would have been the subject
of a TSCA §5(e) or 5(f) actIon but was not processed by or 2 Per—day CC
distributed to others.
Violation where the substance Is or would have been the subject
of a TSCA §5(e) or 5(f) action ançl was either processed by 1 Per—day CC
others or released uncontrolled Into the environment.
Noncompliance with Test Marketing Exemption Restrictions
Overproduction by 102 or less. 3 Per—day CC
Overproduction of more than 10% would be charged as a failure to
submit a PuN.
Violation of exposure related, on-site restrIctions. 2 Per—day CC
Violation of recordkeeping provisions except as specified on 4 One—day CADG
page 26 of the policy.
Violations of the off-site control provisions of a ThE where
the substance was either distributed to consumers or was 1 Per—day CC
released uncontrolled into the environment.
Noncompliance with Research and Development Exemption Restrictions
Violations regarding the labeling of the R&D substance where
the substance was further processed by another fIrm. 2 Per-day CC

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VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Violations regarding the labeling of the R&D sub taftce where
the substance was either di stributed to consumers or was I Per—day CC
released uncontrolled Into the environment.
Please note that any violation of an R&D exemption other
than failure to adequately label the R&D substance, would
cause the charge to be a failure to submit a P1 11 1.
Noncompliance with Low Volume Exemption Restrictions
Violations regarding the notification of customers of the re-
strictions on use of the substance. 2 Per-day CC
Violations regarding the failure to notify EPA of any changes
In site or use of the exempted, chemIcal. 2 Per—day CC
Violations of the recordkeeping provisions of the low volume 3 One—day CADG
exemption except as specified on page 26 of the policy.
Violations of the 1,000 kg. production limit would be viewed
as a failure to submit a PMN.
Violations regarding the failure to maintain required exposure 2 Per—day CC
controls.
Noncompliance with the Instant Photographic and Peel-Apart
Film Article Exemption Restrictions
Failure to limit manufacturing and processing to site(s)
listed In the exemption application. 5 Per—day CC
Distribution in commerce or use of a peel-apart film article
containing a new chemical substance prior to Its being cleared
ttrough the PMN process would be considered a failure to
submit a P1111 and subject to the penalties thereunder.

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6
VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Failure to follow the conditions of manufacturefor Instant
photographic or peel—apart film articles where the substance 2 Per-day CC
would not have been subject to a TSCA §5(e) or 5(f) order.
Failure to follow the conditions of manufacture for instant
photographic or peel—apart film articles where the substance 1 Per—day CC
would have been subject to a TSCA §5(e) or 5(f) order.
Violation of the recordkeeping provisions of this exemption 3 One—day CADG
except as specified on page 26 of the policy.
Noncompliance with Polymer Exemption Restrictions
Violations regarding the submission of test data with the 1 Per-day HA
exemption application.
Violations of the recordkeeping provisions of the polymer
exemption except as specified on page 26 of the polIcy. 4 One—day CADG
All other violations of the polymer exemption would be
charged as a failure to submit a P111 1.
2z,oducti on
Production of a chemical substance after submission of a
PMN but prior to the expiration of the PMN review period. 3 Per-day HA

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VIOLATION LEVEL PER— DAY/ NATURE
ONE—DAY
Production of a chemical substance after submtssion of a PMN
but prior to the expiration of the PMN review period when
the substance becomes or would have been the subject of a 2 Per-day HA
TSCA §5(e) or 5(f) action or the substance was distributed to
cons wne rs.
Production of a chemical substance prior to the expiration of
the PMN review period when the substance becomes or would have 1 Per—day HA
been the subjec’ of a TSCA 55(e) or 5(f) actIon and the substance
was distributed to consumers.
Other Violations
Any other violation not listed above. 4 Per—day HA
EXTENT MATRIX
Nature
A
Major
Extent Level
C
Minor
B
Significant
ChemIcal
Control
‘2,500 lbs
>1,134 kg
‘250 lbs to 2.500 lbs
>113.4 kg to 1,134 kg
>0
>0
to 250 lbs
to 113.4 kg
Control—
Associated
Data-
Gathering
>10,000 lbs
>4,536 kg
>1,000 lbs to 10.000 lbs
>453.6 kg to 4,536 kg
‘0
>0
to 1,000 lbs
to 453.6 kg
Hazard >7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs
Assessment >3.402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg

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ADDRESSEES
Mike Shapiro CTS—788)
Charles. Elkins (TS—792)
Frederick P. Stiehi (LE—134)
Mark Greenwood (LE-].32A)
A.E. Conroy XI (EN—342)
Diane Bea]
John J. NeyXan XIX
Mike Wood -
David Dull
Jerry Stubbs
Phyllis Plaherty
Bob Zisa
Sherry Sterling
Maureen Lydon
Ken Kanagalingam
Jan Bearden
Jake Mackenzie
Western Regional Compliance Director
Dean Hill, NEIC
I Louis F. Gitto, Director Marvin Rosenstein, Chief
Air Management Pesticide & Toxic Subs. rI
II Barbara Metzger, Director Ernest Regna, Chief
Environmental Services Div. Pesticides & Toxic Subs. Br
III Thomas C. Voltaggio Larry Miller, Chief
Acting Director Toxic & Pesticides Branch
Hazardous Waste Management
Division
IV Winston A. Smith, Director Richard DuBose, Chief
Air, Pest. & Toxic Mangt. Pesticides & Toxic Subs. Br
Division
V William H. Sanders III, Dir Phyllis Reed, Chief
Environmental Services Div Pesticides & Toxic Subs. Br
VI William B. Hathaway, Dir Robert Murphy, Chief
Air, Pesticides & Toxic Subs. Pesticides & Toxic Subs. Br
Division
VII William A. Sprat]in, Dir Carl Walters, Acting Chief
Air and Toxics Division Pesticides & Toxic Subs. Br
VIII Irwin 1.. Dickatein, Director Alvin Yorke, Chief
Air and Toxics Division Toxic Substances Br
000069

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—2—
IX David P. Howekamp, Director Davis Bernstein, Chief
Air Management DiviSiOn Pesticides Toxic Subs. Br
X Gary O’Neal, Director Kenneth Feigner, Chief
Air and Toxics Division Pesticides & Toxic Subs. Br
cc: Michael Walker (LE—134P)
Jim Willis (TS—788)
Alicia Tenuta (A—107)

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, iIO SP 4
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

MAY 15 1981
OPPICC o
P STICIDU AND TOXIC $USSTANCLS
MEMORANDUM
SUBJECT: Final Enforcement Response Policy fo
and 13
FROM: John J. Neylan II I, Director
Policy and Grants Division
Office of Compliance Monitorl
TO: Addressees
Attached is the final revised Enforcement Response Polcy
(ERP) for TSCA § 8, 12 and 13. The final ERP remains very similar
to the proposed ERP issued on March 27, 1987 with changes made in
three areas. Failure to maintain TSCA §8(c) records in a manner
that meets the standard required in the rule has been made a sig-
nificant, level 3, one—day violation ($10,000). The second change
made is the addition of a violation for failure under the ISCA
§8(a) Inventory Update Rule to keep records showing that the manu-
facturer Is not subject to reporting. under the rule (major, level
6, $2,000). The third change to the ERP is a modification in the
per day assessment for violations of TSCA §8(a) Chemical Specific
rules. The per day assessment is now the the base penalty divided
by 360. The maximum penalty for failure to report is now $34,189,
while the maximum penalty for late reporting Is $12,067.
This ERP supercedes the previous ISCA § 8, 12 and 13
ERP and Its two succeeding amendments. I would once again like
to thank the Regions for their comments and cooperation In formu-
lating this ERP, especially the Regional participants in the
workgroup. If you have any questions concerning this final ERP,
please contact David Stangel of my staff at (FTS) 382—7825.
A discussion of the comments is attached.
Attachments
000071

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Addressees
Charles Elklns
Frederick F. StIehi
Stanley Abramson
Ken Shirolshi
Phyllis Flaherty
John Martin
John J. Neylan-Ill
Ralph Turpin
Mike Wood
Gerald Stubbs
Dexter Goldman
Michael Walker
Margaret Rostker
Michael Stahl
Jake Mackenzie
Western Regional Compliance (11 rector
A. Charles Lincoln
Eastern Regional Compliance Director
Louis F. Gitto, Director
Air Management Division, Region I
Barbara Metzger, Director
Environmental Services Division, Region II
Stephen R. Wassersug, Director
Hazardous Waste Management Division, Region III
Winston A. Smith, Director
Air, Pesticides and Toxics Management Division, Region IV
William H. Sanders III, Director
Environmental Services Division, Region V
William B. Hathaway, Director
Air, Pesticides, and Toxics Division, Region VI
William A. Spratlin, Director
Air and Toxics Division, Region VII
Irwin L. Dlckstein, Director
Air and Toxics Division, Region VIII
Jeffrey Zelikson, Acting Director
Toxics and Waste Management Division, Region IX
Gary O’Neal, Director
Air and Toxics Division, Region X
(TS—792)
(LE-134A
(LE-132A
(EN—342)
II
U
I,
U
U
I,
(LE—134P)
(TS—788)
(TS—788) (Asbestos documents)
Regional Pesticides and Toxic Substances Branch Chiefs

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RESPONSE TO COMMENTS
Comment:
The penalties for TSCA §8(a) Chemical Specific reporting are
too high and should be assessed as a one—day penalty in the same
way that Inventory violations are handled.
Re s ponse:
The Office of Compliance Monitoring and the Office of Toxic
Substances feel very strongly that penalties for TSCA §8(a)
CAIR and PAIR violations be higher than those for TSCA §8 Inventory
violations. In most cases, the Agency is asking for the informa-
tion under very strict statutory or court Imposed deadlines and
the information is used to .determlne how the Agency will regulate
a chemical substance. The failure to report data in a timely man-
ner could seripusly impairthe decision to regulate a chemical
substance. We are, however, sensitive to the Region’s concerns
regarding the amount of the penalties. The ERP, therefore, has
been amended to reduce the amount of the per day penalty by di-
viding the base penalty by 360 instead of 180. ThIs would re—
suit in a maximum penalty for failure to report violations of I
$34,189, with $12,067 being the maximum assessed for late report-
ing. Both OTS and 0CM feel that while the penalties are higher
than those in the previous ERP, they are appropriate and shall
remain per day violations.
Comment:
The TSCA §8(a) Inventory Update penalties are too high con-
sidering that many of the violators will probably have multiple
violations, due to ignorance of the regulations.
Response:
While we agree that there may be instances where a manufac-
turer is ignorant of the regulations, these instances should not
dictate the penalty structure. The Inventory Update Rule Is con-
structed In such a way that most small manufacturers (the group
most likely to be ignorant of the rule) are exempt from reporting.
In the event that a manufacturer fails to report on a large num-
ber of substances, the size of the business may mitigate the pen-
alty or the company could undertake other activities to mitigate
the penalty. If a large manufacturer fails to report on a large
number of substances, a substantial harm may have occurred to the
Agency’s efforts to characterize exposure and the penalties would
be appropriate.
000073

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-2-
Comment:
The penalty policy is inconsistent in that a failure to re-
cord ISCA §8(c) allegations at all is categorized as a significant
level 1 violation ($17,000) while a company that does keep aflega-
tions but fails to keep them in the manner prescribed Is assessed
a major, level 2 violatIon ($20,000).
Response:
We agree that this situation is Inequitable. The ERP has
been amended so that a failure to maintain TSCA §8(c) records
In a manner that meets the standard required In the rule woula
be a significant, level 3, one—day violation ($10,000). There
may be Instances of a failure to maintain records or reports In
a manner that meets the standard required In other rules so the
violation will be reflected- as both a level 2 and a level 3 vio-
lation. The ERP distinguishes between TSCA §8(c) records and
other records.
Comment:
The ERP should incorporate some method of employing gross
market share/volume categories when determining penalties.
Response:
The workgroup has discussed a number of methods of factoring
market share or volume into the penalty calculations and has not
been able to develop a workable system to Incorporate these para-
meters into hazard assessment. Basically, the workgroup does not
believe that harm can be related to market share. Other problems
with such an approach are accurately determining market share,
dealing with those chemicals where the Agency is concerned with
very small amounts of a substance, and the potential for divulging
confidential business Information.
Comment:
The current system of referring TSCA §13 cases to the Region
where the importer Is located rather than allowing the Region where
the entry, and subsequent violation, occurred to take the case
is Inequitable.
Response:
0CM agrees that Regions where the majority of importation
occurs bear a much greater resource burden without receiving pro-
per recognition for the resources expended. We are reluctant to
once again amend the SPMS reporting system to include Information
on referrals to other Regions. We propose to Include this infor-
mation on the PC Tracking System and have these referrals be re-
flected In workload modeling.

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—3—
Comment:
Regions should charge brokers with violations of TSCA §13 as
a means of acheiving compliance with the import regulations.
Response:
This office is deeply concerned with the practice of bringing
actions against a broker as a means of reducing the number of ISCA
§13 violatIons. The regulations at 40 CFR 707.20 require the Im-
porter to certify compliance with TSCA for all chemical substances
imported. The Importer is clearly the responsible party regard-
less of the type of contractual arrangement the importer may have
with the broker. It is the responsibility of the importer to do
business with responsible brokers. While we agree that brokers
are responsible for many of the violations that occur and a tech-
nical assistance program would be of great benefit to educate the
brokers, the importers areultimately responsible for compliance
with TSCA notwithstanding the actions of their agents. An importer
may wish to recover damages from a broker after the Agency has
concluded its civil action, but that Is a matter for which the
Agency has no concern. National policy requires that civil ac— 1
tions be directed to the Importer of record. Questions have been
raised as to the legality of directing any type of enforcement
actions towards the broker which 0CM and OECM are attempting to
address. Regions may wish to consider an educational campaign
for those brokers who commit violations of TSCA §13, along with
an informal warning letter to the broker stating the violation.
Comment:
Headquarters should reconsider the policy of concurrence for
all cases settled under the new ERP, especially those taken under
TSCA §13.
Response:
This ERP was revised In part to answer the concerns of the
Regions that the penalties under the old ERP were unrealistically
high and based mainly on when EPA conducted an Inspection rather
than the potential harm that could have occurred. We feel that
these concerns have largely been answered by this document.
While the penalties assessed under this ERP will generally be
less than those In the past, we are concerned that penalties may
be reduced as they were In the past. We feel that the differ-
ences between the penalty assessed and the penalty collected
should be much smaller under this ERP than in the past. We
are more concerned with penalties under TSCA §8, but feel It
would be beneficial to monitor the penalties assessed for all
,.‘ 7
lj,J J )I )

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-4-
violations under this ERPI We anticipate re axat1on of con-
currence for TSCA §13 violatIons to be forthcoming after re-
viewing the actions taken under this ERP. However, given the
wide disparity in how the Regions administer actions under
TSCA § 8, 12 and 13 at this time, we feel that requiring con-
currence as a means of administering the new ERP Is prudent.
Comment:
0CM should distribute drafts of ERPs to the Office’s of Re-
gional Counsel as well as the Regional program offices.
Response:
At the insistence of the Office of Enforcement and Compliance
Monitoring (OECM), drafts of ERP’s are directed to that office with
OECM being responsible for transmitting these documents to the ORC.

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MAY 15 1981
RECORDKEE [ NG AND REPORTING RULES
TSCA SECTIONS 8, 12 AND 13
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U.S. ENVIRONMENTAL PROTECTION AGENCY
oooo;’7

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INTRODUCTION
Section 8 of the Toxic Substances Control Act (TSCA) author-
izes EPA to require chemical manufacturers, importers and pro-
cessors to keep records and to report certain information. TSCA
§12 requires the submission to EPA of Information about chemical
exports. The TSCA §13 rule requires the submission of certifica-
tion statements concerning import shipments of chemical substances.
These reporting and recordkeeplng provisions have similar types
of requirements, and therefore, similar types of violations. For
this reason, this Enforcement Response Policy addresses all these
provisions as TSCA reporting and recordkeeping requirements.
Failure to comply with the recordkeeplng and or reporting
provisions of TSCA Is a violation of TSCA § 15(3)(A) and 15(3)(B)
and subject to the remedies In TSCA §16.
Summary of Requirements/Rules Covered
TSCA §8(a) Inventory - Required reporting during 1977 by person
who manufactured and/or Imported reportable chemicals. (At this
date, these violations are most likely failures to report or
falsified reports.) (40 CFR 710)
TSCA §8(a) Inventory Update - Requires reporting by persons who
manufacture or import chemical substances which are on the TSCA
Chemical Inventory in quantities greater than 10,000 lbs. at a
specific site. Small businesses and certain classes of chemicals
are excluded. (51 FR 21438, June 12, 1986, 40 CFR 710)
TSCA §8(a) Preliminary Assessment Information Reporting Rule
( PAIR) - kequires reporting by persons who manufacture or im-
port listed chemicals in quantities greater •than 1,100 lbs.
per site. Small businesses are excluded. (47 FR 26992,
June 22, 1982, 40 CFR 712)
TSCA §8(a) Asbestos Reporting — Required reporting by persons
who mined, manufactured, imported , or processed asbestos by
November 1, 1982. ExemptIons included small businesses, dis-
tributors, and builders. (47 FR 33198, July 30, 1982, 40 CFR 763)
TSCA §8(a) Chemical Specific Rules
TSCA §8(a) P-TBBA, P-TBT, P-TBB - 40 CFR 704.33
TSCA §8(a) Chlorinated naphthalenes — 40 CFR 704.83
TSCA §8(a) Chlorinated terphenyl — 40 CFR 104.85
TSCA §8(a) Hexachioronorbornadiene — 40 CFR 704.142
TSCA §8(a) 4,4’—methylenebis(2—chloroanhline)(MBOCA) —
40 CFR 704.175
030079

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-2—
ISCA §8(a) Polybrominated biphenyls (PBBs) — 40 CFR 704.195*
TSCA §8(a) Tris (2,3—dibromopropyl) phosphate — 40 CFR 704.20
* These rules have been “sunsetted” and replaced by SNUR’s.
TSCA §8(c) Alleged Significant Adverse Reactions - Requires
persons who manufacture, import, process, or distribute chem-
ical substances or mixtures in commerce to keep files of alle-
gations of significant adverse reactions and provide this in-
formation to EPA upon request. Exemptions include persons
whose activities consist of mining or other solely extractive
functions; processors who are not also manufacturers if none
of the processors’ sites are engaged In activities described
in SIC 28 or SIC 2911; and persons who are solely distributors
or retailers. (48 FR 3817a, August 22, 1983, 40 CFR 717;
amended 50 FR 46766, November 13, 1985, 40 CFR 717)
ISCA §8(d) Health and Safety Studies SubmissIon.. — Requires
persons who manufacture, import, process, or propose to manu-
facture, Import, or process listed chemicals to submit lists or
copies of unpublished studies to EPA. (47 FR 38780, September
2, 1982, 40 CFR 716 amended September 15, 1986, 51 FR 32720)
TSCA §8(e) SubstantIal Risk Reporting — Requires persons who
manufacture, import, process, or distribute in commerce a chem-
ical substance or mixture and who obtain anew” information which
reasonably supports the conclusion that such substance or mix-
ture presents a substantial risk of injury to health or the en-
vironment to report such Information to EPA within 15 days.
(Policy Statement, 43 FR 11110, March 16, 1978)
ISCA §12 Exports — Requl res persons who export chemicals subject
to final and certain proposed rules and orders under sections
4, 5, 6 and 7 of TSCA to notify EPA of the country of destina-
tion the first time a chemical Is shipped to that country during
a calender year. (45 FR 82844, December 16, 1980, 40 CFR
707.60)
TSCA §13 Imports — Requires persons who import chemical sub-
stances to certify that each shipment Is in compliance with TSCA
or is not subject to TSCA. (48 FR 34734, August 1, 1983, 19 CFR
12.118 through 12.127 and 127.28 amended, and 40 CFR 707.20)
Future TSCA §8 Rules — This policy also covers all future
rules promulgated under TSCA §8 or amendments to the above
rul es.

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DETERMINING THE LEVEL OF ACTION
Enforcement alternatives Include a notice of noncompliance,
a civil penalty, injunctive relief, criminal action, or some
combination of these actions.
Notice of Noncompliance
A notice of noncompliance (NON) Is appropriate where:
(1) the violation is a first-time violation of ISCA § 12 or 13
where there are no other TSCA violations for the shipment or
(2) minor violations of TSCA 8 as specified below where the
violator has not received a previous NON for a violation
of that particular subsection. Violations of ISCA §8
which warrant NON’s are:
o Minor technical omissions, I.e., failure to supply
required noncritical Information (such as, the phone
number of a technical contact).
o FaIlure to use certified mall In making a notification
(as required by a rule);
o Report sent to incorrect address but correctly identified
as a TSCA §8(_) submission;
o Report sent to correct address but not identified as a
TSCA §8(_) submission;
Administrative Civil Penalty
An administrative civil penalty will be the appropriate
response for most violations of these regulations.
Concu rrence
Civil penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring of the Office of Pesti-
cides and Toxic Substances prior to Initiating a civil adminis-
trative penalty for TSCA § 8, 12 and 13. Reductions for settle-
ment purposes require the concurrence of 0CM as well and must
be in accordance with the TSCA Penalty Policy and this ERP.
OOOO :i I

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-4-
Each reduction must be justified in the consent agreement and
final order and specific dollar amounts attributed to each re-
duction. Headquarters may relax concurrence requirements on
a Region by Region basis after the Regions have gained experi-
ence with actions under these rules and the ERP.
Injunctive Action
Injunctive action under ISCA may be appropriate in certain
circumstances. Although §17 of TSCA can be a very effective
tool in obtaining compliance, It is also more resource inten-
sive than a civil penalty action. In addition, it has been
the Agency’s experience that a civil penalty action is usually
sufficient to obtain compliance. For these reasons, the Agency
believes that the use of TSCA §17 remedies generally should
be limited to those instances where a civil penalty action will
not result in sufficiently swift compliance to protect human
health or the environment. For example, injunctive action may
be used to require a company to maintain records where the atti-
tude of the violator indicates that this would not be done
otherwise or where there Is a repeated history of failure to
keep records.
Criminal Sanctions
Criminal sanctions pursuant to TSCA §16(b) are the most
serious sanctions available for violations of the recordkeeplng/
reporting rules. Accordingly, criminal sanctions may be sought
in situations that —— when measured by the nature of the conduct,
the compliance history of the subject(s) or the gravity of the
health or environmental consequences —— reflect the most serious
cases of misconduct.
Several factors distinguish criminal cases from administrative
or civil actions. First, criminal sanctions will ordinarily be
limited to cases in which the prohibited conduct is accompanied
by evidence of ugulity knowledge or intent on the part of the
prospective defendant(s). TSCA Imposes criminal penalties only
for violations of the Act which are committed “knowingly or
willful lye.
A second factor to consider is the nature and seriousness of
the offense. As a matter of resource allocation, EPA will Inves-
tigate and refer only the most serious forms of misconduct. Of
primary importance to this assessment Is the extent of environmental
contamination or human health hazard that resulted from, or was
threatened by, the prohibited conduct. Also of significance is
the impact, real or potential, on EPA’s regulatory functions.

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—5—
Third, the compliance history of the individual(s) or per-
son(s) for a potential criminal case is important. Criminal
sanctions become more appropriate as incidents of noncompliance
increase. While not a prerequisite, a history of noncompliance
will often indicate the need for criminal sanctions to achieve
effective individual deterrence.
Multiple Remedies
There may be unusual instances where a particular situation
will present facts that suggest that more than one final action
should be taken. 0CM does not encourage the use of multiple re-
medies for the reasons discussed below. The purpose of this
Section is to outline when multiple remedies are appropriate.
Criminal Sanctions
Simultaneous civil and criminal enforcement proceedings are
legally permissible, United States v. Kordel , 397 u.s. 1, 11
(1970), and on occasion are clearly warranted. These cases
should be the exception rather than the rule. When parallel
proceedings are contemplated, please refer to the Office of En-
forcement and Compliance 1onitor1ng guidance on parallel procedd-
ings (January 23, 1984).
Notice of Noncompliance
In general, a notice of noncompliance should not be used in
conjunction with any other final remedy. Where a particular
situation presents several violations, some of which would merit a
notice of noncompliance, while others would merit civil penalties,
no notice of noncompliance should be sent. Instead, an adminis-
trative penalty action should be initiated, pleading all viola-
tions, with no penalties for minor infractions which would other-
wise warrant an NON.
Civil Administrative Penalties and Specific Enforcement
The criteria outlined in this section antIcipate that civil
penalties and specific enforcement (injunctive action) will be
used sequentially. There may, however, be instances where the
concurrent use of these remedies Is appropriate. If the Region
deems this to be appropriate in any case, it should consult with
0CM and OECM before bringing either action.
‘1 ‘\ 1 ‘ ‘-
1¼.J J J..JJ

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-6-
ASSESSING A CIVIL ADMINISTRATIVE PENALTY
Summary
Back g ro
of the Penalty Policy
u nd
The TSCA Civil Penalty Policy, published In the Federal
Register on September 10, 1980, establishes a system tor det er-
mining penalties in administrative actions brought pursuant to
TSCA §16. Under that system, penalties are determined in two
stages: (1) determination of a “gravity based penalty” (GBP),
and (2) adjustments to the gravity based penalty.
To determine the gravity based penalty, the following factors
affecting a violation’s gravity are considered:
o The nature of the violation.
o The “extent” of environmental harm that could result
from a given violation.
o The “circumstances” of the violation.
These factors are incorporated in a matrix which allows de-
termination of the appproprlate gr vity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made In con-
sideration of these other factors:
o CulpabIlity,
o History of such violations,
o AbilIty to pay,
o AbilIty to continue in business, and
o Such other matters as justice may require.
The TSCA Civil Penalty Policy system provides a framework
for the development of individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the GBP Matrix to assess penalties for
specific violations of TSCA § 8, 12 and 13 and regulations
promulgated pursuant to these sections.

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—7—
App 1 Ic a b lilt y
This policy is immediately applicable and should be used
to calculate penalties for all administrative actions concern-
ing ISCA § 8, 12 and 13 instituted after the date of this policy,
regardless of the date of violation. Pending cases should be
reviewed to determine whether the penalty calculated under this
policy is lower than the penalty In the civil complaint. If
this policy yields a lower penalty, an amendment to the com-
plaint should be made to substitute the lower penalty. This
policy should not be used to raise penalties In existing actions.
No case should be settled for an amount higher than the penalty
which this policy wouldyield.
Calculation of the Gravity Based Penalty
Penalties for TSCA § 8, 12 and 13 vIolations vary depending
on tne extent, circumstances, whether penalties are to be calcu-
lated as one day assessments versus per day assessments, and by
capping the number of days for which a violation may be assessed
as appropriate. In establishing each of these, the Agency con-
sidered the following factors In a comparative manner:
o Impact on the Agency’s decision making process.
o RelatIve degree of harm caused by failure to comply.
o Timeframes In which the Agency decision making process
generally occurs.
o Time to generate information not reported.
° Relative costs of studies.
o Likelihood that sufficient Information is available from
other sources.
° Type of Information Involved, I.e., human exposure versus
animal toxicity studies and allegations versus actual data.
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent of each violation, Is to be determined
by using the following matrix:
000085

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-8—
EXTENT
CIRCUMSTANCES
A 1
MAJOR
B
SIGNIFICANT
C
MINOR
- Levels
1
High Range
2
I
$25,000 $17,000
$20,000 $13,000
$5,000
$3,000
3
Mid Range
4
.$ 15,0 00
$10,000
$10,000
$6,000
$1,500
$1,000
5
Low Range
6
$5,000
$2,000
$3,000
$1,300
$500
$200 ‘
After determining the initial or Nbase penaltyu from the ma-
trix for the first day of violation, add the penalty for each addi
tional day of violation based on the Instructions In the UPenalty
for Each Day of Violationu heading. Whether a penalty Is to be
assessed as a one day assessment or as a continuing violation on
a per day basis Is included In the Circumstances sections. Days of
violation are based on calender days, not workdays.
Nature
A violation may be either chemical control, control—asso-
ciated data gathering, or hazard assessment In nature. For pur-
poses of assessing a penalty, the nature of a recordkeeplng/
reporting violation Is uhazard assessment.
Circumstances
The first step in selecting the base penalty is to deter-
mine which level on the circumstances axis applies to the
violation.
The circumstances axis of the GBP matrix reflects the
probability that harm will result from a particular violation.
For recordkeeplng and reporting rules, violations rank as fol-
lows on the circumstances axis:

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-9-
CIRCUMSTANCE LEVEL
lEVEL 1 Nonreportlng for TSCA §8(e) Per day
Nonreportlng for TSCA §8(e) Emergency One day
Incident of Environmental Contamination
Nonreporting for TSCA §8(d) Per day
Non reportlng for TSCA §8(c) Per day
Nonreporting for TSCA §8(a) ChemIcal Per day
Specific Rules
Nonreporting for Inventory Update One day
Nonreporting for Inventory One day
Failure to keep records (not TSCA §8(c)] Per day t
Failure to record ISCA §8(c) allegatIon One day
False/Incorrect/mIsleading reporting Per dayt
LEVEL 2 FaIlure to maintain records/report in a One day
manner that meets the standard required in
the rule. ISCA §8(c) vIolations are level
3.
Failure to report under TSCA §8(d) involvIng One day
omission of study In list of studies which a
manufacturer or processor knows of but which
is not in his possession.
LEVEL 3 Failure to report completely after EPA has Per day
requested missing information or a correc-
tion of erroneus information.
Failure to maintain TSCA §8(c) records/ One day
report In a manner that meets the standard
required in the rule. Assess one violation
where all allegations are filed but not In
the manner presri bed.
TSCA §13 VIolation (first or otherwise) One day
where a positive/negative/no certification
was submitted but the chemical does not com-
ply with other TSCA provisions.
LEVEL 4 Late reporting — For definition of late Per day t
reporting parameters, see the Compliance
Monitoring Strategy for each rule. Does
not apply to the original Inventory Rule,
TSCA §12 and TSCA §13.
TSCA §12 violations after company has One day
received a previous notice of noncompliance
for a violation of TSCA §12.

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-10-
ISCA 13 violations where a negative/no cer- One day
- tiflcation is submitted hut the chemical is
subject and chemical is In compliance with
all other TSCA provisions as specified in
the ISCA §13 regulation and the company has
received a previous notice of noncompliance
for a violation of TSCA §13.
LEVEL 5 No violations are level 5.
LEVEL 6 MInor technical omission — Example: omitted One day
name of technical contact but included title
and phone number so the Agency was able to
reach the correct person. (See Notice of
Noncompliance.)
TSCA §8 report sent to incorrect office and One day
was not ldentifi•ed as a TSCA §8( ) submis-
sion as required.
TSCA §8 report sent to incorrect office and One day
was identified as a TSCA §8 report after
company has received a previous notice of
noncompliance for a violation of the same
subsection.
TSCA §8 report sent to correct office but One day
not identified as a TSCA §8 report after
company has received a previous notice of
noncompliance for a violation of the same
subsection.
Failure to keep records showing that the One day
manufacturer is not subject to reporting
under the TSCA §8(a) Inventory Update
Rule.
Extent
The second step In selecting the base penalty for a specific
violation from the matrix is to determine its position on the
extent axis.
This axis of the GBP matrix reflects the extent of potential
harm caused by a violation. In the case of recordkeeplng/reportlng
rules, harm is defined as the inability of the Agency to carry out
its risk assessment responsibilities under TSCA.
* One day for Inventory Update, Inventory, TSCA §12, TSCA §13,
TSCA §8(e) EIEC’s, and TSCA §8(d) Involving lists of studies
which a manufacturer or processor knows of but which are not
In his possession.

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—11—
EXTENT LEVEL
MAJOR Violations of TSCA § 8(c), 8(d), or 8(e)
which involve information which directly
Interferes with the Agency’s ability to address
situations Involving potential imminent hazard,
unreasonable risks, or substantial endangerment
to health or the environment .,*
Violations of TSCA § 8(d) and 8(e) involvIng
human data.
Violations of TSCA §8(e) Involving Information
on emergency Incidents of environmental contain-
in.ation (EIEC).
All Circumstance Level 2 vIolations.
All Circumstance Level 6 vIolations.
SIGNIFICANT Violations of TSCA § 8(d) and 8(e) involvIng
animal/aquatic studies, environmental monitor-
ing, workplace monitoring (not Invasive human
monitoring), and any other study not addressed
In the major or minor extent level.
Violations of CAIR, PAIR, TSCA §8(a) chemical
specific rules, TSCA §8(c), Inventory, and
Inventory Update Rule exc.ept Level 2 or Level
6 violatIons.
Violations of ISCA §12.
Violations of TSCA §13.
MINOR Violations of TSCA
chemical properties
§8(d) InvolvIng physlcal/
or envi ronmental fate data.
* This determination must have written concurrence from OPTS.
000089

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Per Day Assessments
Where per day assessments are provided for in the Circum-
stances Level section, the base penalty is calculated for
the first day of violation and per day pena1ties are assessed
for each subsequent day of violation based on the following
fo rmul a:
Violations Involvin 9 Potential Imminent Hazard/Substantial
Endangerment Si tuat ons/Unreasonable RI SkS
Base X Each day of violation = Penalty
Penalty
TSCA §8(e )
Base + ( No. of days of violation — 1) x base penalty Penalty
Penalty 30
ISCA §8(a) Chemical Specific 4
Base + ( No. of days of violation - 1) x base penalty = pena1t *
Penalty 360
All others
Base + ( No. of days of violation — 1) x base penalty penalty*
Penalty 180
* The number of days of violation cannot exceed caps as
designated In the following section.
Caps on Number of Days for Penalty to be Assessed Per Violation
TSCA §8(e) No cap
TSCA §8(d) 5 year cap Major Extent Violations
3 year cap Significant Extent Violations
1 year cap Minor Extent Violations
TSCA §8(c) 1 year cap
ISCA §8(a) 1 year cap
Chemical
Specific
PAIR 1 year cap
CAIR 1 year cap

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Determinfng Number of Violations —
Multiple penalties are to be used if there is more than
one violation of the same rule or violations of different rules.
Violations will be determined as follows:
TSCA §8(a) Per Chemical
ISCA §8(a) Per Chemical Per Site
TSCA §8(a) Per Chemical Per Site
TSCA §8(a) Per Chemical Per Site
TSCA §8(a) Per Chemical (Per Chemi-
Rules cal Per Site If Site—Spe-
cific Reporting Is Re-
quired)
Per Allegation Submitted
to Company and Not Filed
Per Requirement Not Met
Per Firm
1
I nv e n to ry
Inventory Update
PAIR
CAIR
Chemical Specific
TSCA §8(c) Failure to Keep
Records
TSCA §8(c) FaIlure to Keep
Records as Requl red
TSCA §8(c) Report
TSCA §8(d)
TSCA §8(e)
Per Allegation Not Reported
Per Study Per Chemical
Per Type of Reportable
Effect or Event Per
Chemi ca
TSCA
§12
Per
Chemical
Per
Coun-
try
Per Year
TSCA
§13
Per
Shipment
Per
Port
000091

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Determining the Gravity Based Penalty
The circumstances level and the extent category for each
violation will define a base penalty in the matrix. For those
violations designated as per day In the circumstances matrix,
calculate the penalty as Indicated under per day assessments,
taking into account the caps on the number of days the penalty
is to be assessed. This total penalty should be entered on line
1 of the TSCA Civil Penalty Assessment worksheet and adjusted
by the appropriate factors discussed In the ISCA Civil Penalty
System and this policy.
Adjustment Factors
The ISCA Civil Penalty System discusses appropriate adjust-
ment factors. In addition, adjustment factors specific to this
policy are discussed below..
Voluntary Disclosure (Other Factors as Justice May Require )
The ERP establishes fixed percentage reductions In penal-
ties for voluntary disclosure of violations for the following
sections only: TSCA 8(a) Inventory Rule, TSCA §12, and TSCA
§13. For all other sections, the voluntary disclosure of a
violation is to be treated as a late report, and therefore,
the violator re e1ves a substantial reduction since the
circumstance level moves from Level 1 to Level 4.
For TSCA § 8(a) Inventory Rule, 12 and 13, the adjustment
factors for voluntary disclosure Is as follows:
Disclosure ............................. 25%
Immediate disclosure within
30 days of discovery ................... 25%
TOTAL 50%
The Agency will not consider disclosure voluntary If the
company has been notified of a scheduled inspection or the
inspection has begun. Information received after these
events will be considered as failure to report/file.
However, if, for example, an inspector is conducting a TSCA
§8 inspectIon at an establishment, and the company voluntarily
discloses a TSCA §13 violatIon and the inspector would not
have any expectation of discovering such a violation, the TSCA
§13 violation would be considered to be voluntarily disclosed.
This example would also apply to TSCA §12 vIolations. For
TSCA §12 and §13 violations, If a company discloses addi-
tional violations during or prior to settlement negotiations,
those violations are eligible for voluntary disclosure reduc-
tions. The Region may deal with this situation through:

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1) an amendment to the original complaint; 2) an additional
complaint; or 3) addressIng additional charges in the Consent
Agreement and Final Order.
Economic Benefit
In no case should the final penalty imposed be less than
tite economic benefit. In those cases where the initial penalty
is less than the economic benefit derived from noncompliance,
EPA reserves the right to Impose per day penalties up to
$25,000 per day to assure that the penalty is not less than
the economic benefit.
Exposure Reduction (Other Factors as Justice May Require )
In cases warranting per day assessments of the base penalty,
i.e., those involving potential imminent hazard, etc., if the
- Respondent has credible evidence by affidavit which shows, for
example, exposure has ceased by all routes of exposure, environ-
mental and/or commercial; that evidence may be considered to
mitigate the penalty. In those cases, the penalty will be as-
sessed at the maximum base penalty per day during the duration
of the exposure presenting Imminent hazard/substantial endanger-
ment/unreasonable risk and assessed as a violation not presenting
the potential hazard/risk/endangerment during the time that
the hazard/risk/endangerment had ceased to exist.
Attitude
For ISCA §13 violations, If the company had a system In
place to track Import certifications and comply with TSCA
§13 requirements, and a chemical “slips through”, a 15% good
attitude reduction may be given as provided for in the TSCA
Penalty Policy. Larger reductions are inappropriate In that
companies are required to comply with certification require-
ments and credit should not be given for attempting to comply
with the law. If a company experiences numerous occasions
where chemicals slip throughu their system, a good attitude
reduction Is no longer appropriate.
History of Previous Violation
The Agency will disregard the firm’s prior history of
violations In calculating the penalty for a self—disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as indi-
cated In the TSCA Penalty Policy, even if the prior history
results from a violation which was voluntarily disclosed.
Q00G93

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Explanation of the Penalty Policy
Nature
TSCA § 8 and 12 require that information concerning
chemicals be reported to EPA or kept at the company and made
available to the Agency. TSCA §13 requires Importers to certi-
fy that chemicals imported are either not subject to TSCA or
are in compliance with TSCA.
SectIon 8 Information is used by the Agency to evaluate the
potential risks associated with the manufacture and use of a
chemical. This data gathering often occurs at the early stages
of regulatory decision making. Therefore, complete and accurate
information Is essential, incomplete and Inaccurate information
will have far-reaching effects on the Agency’s risk assessment,
regulatory priority setting, and regulation development processes.
Some information such as TSCA §8(e) information may affect the
Agency’s ability to inittate Immediate action necessary to pro-
tect health and the environment, e.g., seeking injunctive relief.
In addition, reports under the original Inventory Reporting Rulif
establish the basis for what is an “existing” chemical versus
a “new” chemical, the latter being those for which a premanu—
facture notice must be flied and the chemical reviewed by the
Agency.
Section 12 collects information about the export of chemicals
subject to certain proposed or final testing or regulatory require-
ments under TSCA § 4, 5, 6, or 7. The Agency provides this Infor-
mation to the government of an Importing country to allow that
country to Initiate Its own risk assessment process.
The section 13 rule describes procedures for certifying that
imported chemical substances subject to TSCA are In compliance
with ISCA. This information permits the Agency to determine if
importers of chemicals are complying with applicable TSCA regula-
tions.
Circumstances
The circumstances axis of the GBP matrix reflects the
probability for harm resulting from a particular violaton.
For the reporting rules, the potential harm caused Is the harm
to the Agency’s regulatory program for controlling health and
environmental risk. For violations of the original Inventory
Reporting Rule, the potential harm is that a new chemical may
be produced with no prior review contrary to the Intent of
TSCA because an Inventory Rule violation resulted in a chemical
being placed on the Inventory which was not an “existing” chem-
ical under TSCA. For chemicals which other persons also reported,
the harm deals with the Information on the estimated produc-
tion volume and sites of manufacture which the Agency uses in
its risk assessments, including those for TSCA §4 test rule
decisions. For section 12 reportiny, the potential harm Is

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—17—
to the Agency’s ability to carry out its responsibility to
notify other countries. Thus, violations have the potential
to also harm another country’s regulatory program.
1igh Range Violations — Level 1
Nonreporting/failure to report or to keep records Is an
extremely seflous violation of these rules. The Agency will have
to proceed with che ’iica1 assessment and priority setting, and
perhaps, even regulation development, especially for TSCA §4
test rules, without critical information or without the knowledge
that such informaton even exists. This is true even If a company
reports some information but does not report each study or under-
reports the extent of health effects or number of allegations for
a particular effect. Thus, each report omitted or incompletely
reported will be treated as a separate nonreporting violation.
False/Incorrect/mIsleadIng reporting of information Is
equally harmful because the Agency Is misled In Its analysis of
the potential risks posed by the chemical or In the amounts or
types of Information available.
TSCA §8(c) violations In level 1 Include failure to keep
records and failure to report If the Agency has requested that
the Information be submitted. Thus, If a company has received
TSCA §8(c) allegatIons, but does not maintain TSCA §8(c) records,
and the Agency requests that TSCA §8(c) allegations be submitted
and the company falls to make a submission, there are two viola-
tions - one for the failure to keep records and another for the
failure to report. Even if a company submits most allegations
but not all, each failure to submit an allegation shall be
separately charged and assessed as a failure to report.
ISCA §8(d) level 1 vIolations Include the following:
- Failure to submit unpublished studies in the
manufacturer’s, Importer’s or processor’s
possession.
— Failure to notify EPA of unpublished studies
the manufacturer, importer or processor
knows of but is not In possession of.
- Failure to notify EPA of ongoing studies which
the manufacturer, importer or processor
Initiated or sponsored. Includes future studies
required to be reported once they are Initiated.
- Failure to send EPA the final report of a
study which was listed as an ongoing study.
Includes future studies required to be
submitted.
000095

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Failure to submit underlying data to EPA on
EPA’s request.
Failure to comply with the TSCA §8(e) reporting requirements
is potentially the most serious violation of TSCA §R. TSCA §8(e)
reports alert the Agency to new information which may have a
hearing on the Aqency’s regulatory efforts. This ERP reflects
thp seriousness the Agency attaches to violations of TSCA §8(e)
by placing no caps on the penalties assessed for these violations.
High Range Violations — Level 2
Failure to maintain records or report in a manner that meets
the standard required by the rule has effects similar to falsi—
fled Information. Both mislead the Agency nd are difficult to
detect. Failure to report In a manner that meets the standard
refers to those cases where reporting Is essentially complete
and the missing/incorrect information does not impact the
report In such a manner as to mislead the Agency. An example
is the failure to report one ongoing ISCA §8(d) study when
another similar study is reported by the company. Another
example Is a small error in reporting production volume, I.e.,
less than an order of magnitude (a factor of 10).
Level 2 also includes a TSCA §8(d) violatIon involving
the failure to report a study which a manufacturer knows of
but which Is not In his possession. The Agency considers this
violation to have less potential harm than other failure to report
violations since the Agency Is likely to learn of this study from
other persons reporting.
Mid Range Violations - Level 3
Failure to report completely after EPA has requested missing
information is a significant violation. Such a violation denies
the Agency access to Information necessary to Its analysis of
chemical risks. This type of violaton is not as serious as the
high range violations because it is usually relatively easy to
detect and therefore easy to remedy. A form, for instance, will
have blank spaces where answers are expected. Even though the
Agency does not have the Information, it knows that an Information
gap exists, and therefore, is less likely to be misled into making
invalid chemical risk assessments. However, the withholding of
Information is a serious Impediment to risk assessment, and If
It becomes a widespread practice, it could significantly affect
the Agency’s chemical risk assessment processes. Thus, thIs vio-
lation, while not as serious as a total failure to report or
false or misleading reporting, is still of sufficient severity
to be treated in the higher level of the midrange.

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-19-
For ISCA §8(c) files, the failure to maintain reports
as required In the rule, e.g., files which are present but which
are not cross—indexed or which are not kept in one location, in-
volves a level 3 vIolation. in those cases where the company files
this InformatiOn’, and the Agency requests the Information to be
submitted, and information Is not submitted because the company’s
files result in the information not being discovered during the
company’s fil-e search, the failure to submit is a level 1 vIola-
tion. The company may also be charged with the level 3 vIolation.
Please note that failure to file an allegation under TSCA §8(c)
although other allegations are filed constitutes a level 1
failure to keep records violation.
Another level 3 violation Involves ISCA §13 violations
where there is a positive/negative/no certification and the
chemical is in violation of other ISCA provisions. TSCA §13
is designed to assure that an importer takes affirmative responsi-
bility in assuring that his shipments comply with TSCA. Where
other TSCA violations are found, a level 3 vIolation will be
assessed plus appropriate penalties for the other TSCA violations.
Mid Range Violations - Level 4
Reports which are late can significantly slow or disrupt the
Agency’s decision making process. The exact timing may vary on a
rule by rule basl which will be discussed In the Compliance
Monitoring Strategies. Lateness is classified In the lower level
of the midrange circumstances category.
In addition, the Agency has decided to treat reports which
are submitted late as late reporting regardless of the date
of submission, with the exception of reports for the original
Inventory Rule and TSCA § 12 and 13. ThIs decision has been
made to encourage the voluntary disclosure of violations by
assessing penalties as level 4 instead of level 1. For the
original Inventory Rule and TSCA § 12 and 13, a reduction Is
provided for the voluntary disclosure of violations. Reports
submitted or violations disclosed after EPA has notified a
company of a scheduled inspection will be treated as level 1
failure to report violations, except as otherwise indicated
in the Summary of the Penalty Policy.
TSCA §12 violations other than the first violation are
categorized as level 4. The Agency considers TSCA §12 report-
Ing to be Important to its ability to notify other countries
to which chemicals subject to TSCA rulemaking are being exported.
The potential harm is not to the Agency’s decision making process
but to its statutory obligation to notify other countries.
000097

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The Agency considers TSCA §13 vIolations, other than the
first TSCA. §13 violation for which there are no other TSCA viola-
tions, to be mid range level 4 violations. Even if no actual
harm occurs, the violation reflects the importer’s failure to
assure full compliance with ISCA. Failure to certify or filing
a false certification on each shipment circumvents the purpose
of TSCA §13 and could lead to the importation of chemicals
which violate -other provisions of TSCA.
low Range Violations — Level 6
There are no violations which fall within level 5. level 6
violations Include minor technical omissions which do not affect
the Agency’s ability to follow up the Information either by
contacting someone In the company or consulting outside references.
They are among the least ser’ious because the violation Is readily
detected, does not affect Initial risk assessment and may only
slightly hinder the Agency’s decision making process. In
cases where there Is no effect on the Agency, a notice of non-
compliance rather than a penalty may he appropriate. However,
If a company repeats this type of violation, the Agency will
assess a penalty.
Another level 6 violation Is the failure on the part of a
manufacturer to keep records showing that he Is not subject to
reporting under the TSCA §8(a) Inventory Updat Rule, which
requires persons who produce less than 10,000 lbs. of a sub-
stance to maintain records documenting that fact.
Other low range violations Include a submission of ISCA
§8 informatIon which Is not identified as TSCA §8( )
information and which is not sent to the correct oTfice.
Also, submitting the Information to the Incorrect office or
not correctly identifying the Information after a previous
Notice of Noncompliance has been issued for a violation of
that section warrants a level 6 assessment. Although the
Agency receives the information, It may take some time to reach
the correct office or to be placed Into the review process,
and therefore, the Agency’s decision making Is delayed or
Impeded.
Extent
This factor reflects the extent of potential harm to
EPA’s hazard/risk assessment process. The Agency relies
on information gathered under sections 8(a), 8(c), 8(d),
and 8(e) to perform risk assessments. The Agency uses
TSCA § 12 and 13 in a different way. TSCA §12 information is
used In order to notify foreign governments. TSCA §13 is used
to assure that Importers verify and certify compliance with
TSCA.

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For risk assessment, information may be related to toxi-
city or exposure, both important in determining risk. In
examining the extent of potential harm, the type of Information
is Important, i.e., human effects data, human exposure data,
animal data, environmental effects, actual environmental con-
tamination information. Also, scientific studies versus
allegations differ In their importance.
Major Extent
Violations which directly Interfere with the Agency’s
ability to address potential imminent hazard, unreasonable
risk, or 5UbStafltial endangerment to health/environment are
placed In the major extent category. This criteria Is appli-
cable to TSCA 8(c), 8(d); and 8(e). Examples of these types
of violations include: 1) information on Injury to humans
where continued manufacture or use poses a potential Imminent
hazard; or 2) InformatIon on a spill/dumping which Is covered
by TSCA §8(e) and which posed(s) an Imminent hazard or results
in widespread environmental contamination to which persons.
exhibit serious health effects. In the second case, two
violations would be charged, one for the failure to report
the spill and another for the failure to report the health
effects.
Other major extent categories include TSCA § 8(d) and 8(e)
violations involving information on human effects. Such infor-
mation can weigh heavily in the Agency’s decision making
process.
Also, violations Involving emergency incidents of environ-
mental contamination reportable under. TSCA §8(e) are considered
to be of major extent since the Agency needs such information
Immediately. Otherwise, the opportunity to. provide adequate
protection may be lost.
All level 2 and level 6 vIolations are placed in the major
extent category.
Significant
The Agency places slightly less Importance on animal studies
as opposed to data reporting effects In humans. Nonetheless,
such information Is critical to the Agency’s decision making
process. Such tests may be expensive, may take a long time to
000099

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conduct, and require rulemaking by the Agency to obtain them.
For example, If a company fails to report a study it has, the
Agency may decide that such data are needed and proceed to do
unnecessary rulemaking under ISCA §4. Given the time for Such
rulemaking and the time needed to conduct tests and submit re-
sults to the Agency, the violation results in a major delay in
the Agency’s risk assessment of the chemical and an unnecessary
expenditure in resources, both EPA’s and industry’s. Please
note that failure to report a study which is required to be re-
ported but which indicates no adverse effects of the chemical
still results in this harm.
The Agency has also decided to place violations Involving
exposure related data in the significant category when the
EPA has made a decision that it needs Such information for
a specific chemical. Thus, ISCA § 8(d) and 8(e) violatIons
involving exposure related.lnformation as well as violations
of the CAIR, PAIR, and TSCA §8(a) chemical specific rules,-.
all of which involve exposure related Information, are consid-
ered to be significant category violations. Although exposure
Information Is critical to any risk assessment, the impact on
the Ageny’s decision making if one company fails to report and
all other companies comply is less than if one company falls
to submit a toxicity study since it is less likely that another
company will submit the same study. This distinction Is
reflected in the establishment of caps for different types of
violations.
TSCA §8(c) Involves allegations and not actual test data.
However, such information is important to the Agency’s decision
making process in that it involves patterns of effects and
generally involves human effects. Therefore, these violations
are categorized as significant.
TSCA §8(a) Inventory and Inventory Update Rules are also
designated as significant. Although information under these
rules Is not required as a result of the Agency identifying
a specific need for information on specific chemicals, this
Information provides exposure related Information which is
important to the overall decision making of the Agency in ternis
of setting its priorities and deciding what rulemaking to
pursue.
TSCA §12 violations are also considered significant since
such information is necessary for EPA to carry out its responsi-
bility to notify other countries of chemicals for which EPA
has taken certain actions, I.e., a TSCA §5 order or a final or
proposed TSCA § 4, 5 or 6 rule. TSCA §13 is significant in
that violations hinder EPA/Customs’ ability to monitor ship-
ments for compliance with ISCA.

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141 nor
Two types of violations fall Into the rilnor extent level,
i. ., violations of TSCA §8(d) involvinq physical/chemical
propertiøs r environmental fate data; and violations of TSCA
§8(a), failure to keep records showing that a manufacturer is
not subject to reporting under the Inventory Update Rule.
The TSCA §8(d) violations are categorized as minor based on
the relatively low costs of such studies and the time it takes
for the study to be conducted. The TSCA §8(a) violations are
easy to detect upon inspection and information the company
should already have.
Per Day Penalties or One Day Assessments
The Agency has elected to use one day assessments for
violations of rules which require reporting for all chemicals
meeting certain criteria (such as exceeding a given production
volume per site) as opposed.to Information which is not being
requested on a chemical specific basis. In other words, one
day assessments are appropriate In cases where the Agency uses
the information to set priorities and may use It as the need
arises on a specific chemical evaluation but has not affirma-
tively identified a particular chemical for which specific
information is needed.
In those cases where EPA has Issued a rule which lists a
specific chemical(s), per day assessments are appropriate because
the Agency has identified a need for the Information for risk
identification, risk assessment, or risk management purposes.
Per day assessments also apply to any TSCA §8(e) InformatIon
(except EIEC’s which do not meet the potential imminent hazard/
endangerment criteria). Although the Information Is not being
requested for a specific chemical, it Is likely to be used
Immediately for risk assessment purposes. Per day assessments
are made for those violations where the continuing violation
continues to Impede the Agency’s decision making process.
One day assessment Is appropriate for a failure to list a
TSCA §8(d) study which a company knows of but which is not In
its possession. Level 2 and level 6 violations are to be as-
sessed as one day. Also, TSCA § 12 and 13 are considered to
be one day violations. As with TSCA §8(e) vIolations dealing
with an EIEC, violations of these rules do not impede the
Agency’s regulatory decision making process in that such infor-
mation would not normally result In rulemaking. However, such
information Is necessary for more Immediate actions such as
injunctive relief or seizing chemicals which are otherwise in
violatior. of TSCA, e.g., a TSCA §13 chemIcal imported in viola-
tion of TSCA §5.
Violations involving TSCA §8(c) files, I.e., failure to
record information, are treated as one day violations because
the effect on the Agency’s decision making is not critical
000101

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until the Agency requests the submission of TSCA §8(c) informa-
tion. Once the information is requested, the Agency has a
specific need for the information to make Its decisions. There-
fore, “failure to report” violations under TSCA §8(c) are as-
sessed on a per day basis due to their adverse impact on the
Agency’s decision making.
Per Day Assessment Calculation
For violations Involving TSCA §8(e) InformatIon which dIrectl,
interferes with the Agency’s ability to address situations in-
volving potential Imminent hazard, unreasonable risk, or substan-
tial endangerment to health/environment, the base penalty is to
be assessed for each day of violation. These are the most serious
violations, and therefore, warrant the highest penalties provided
for by the statute.
For other TSCA §8(e) violatIons, the base penalty Is to be
used for the first day of violation. For each day thereafter,
the per day penalty Is the base penalty divided by 30. ThIs ad-
justment was selected for the following reasons: 1) these viola-
tions involve significant adverse effects; 2) the Agency has an
Immediate need for the information in order to protect the pub— I
lic and env.ironment, as reflected In the statute’s language to
“Immediately notify”; and 3) the timing of the Agency’s decision
making process once such data Is received.
For TSCA § 8(c) and (d) violations for which per day assess-
ments are to be made, the base penalty Is to be used for the first
day of violation and for each day thereafter, the per day penalty
is the base penalty divided by 180. For TSCA §8(a) ChemIcal Spe-
cific violations the per day penalty Is the base penalty divided
by 360. This method was selected In order to provide further
distinction between types of violations and their impact on the
Agency’s decison making process and Its mission to protect the
public and the environment.
Caps
In establishing caps for some violations, the Agency took
Into account factors such as the ‘ength of time that a v1o at1on
continues, the timing of the Agency’s decision making process,
the relative costs of studies and the length of time needed If
unnecessary studies are conducted. Please note that the cap
does not refer to a limitation on the time elapsed since the
violation occurred — only a limit on the number of days for
which a penalty Is assessed even though a violation continues
for a longer period.
There is no cap on TSCA §8(e) violatIons. The harm
continues as long as the violation continues.
For TSCA §8(d) studIes, which often relate directly to
ISCA §4 rulemaking, the caps depend on the type of study, the
length of time to conduct the study, the relative costs of the
studies, and the timing of the Agency’s decision making.

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For other TS.CA §8 vIolations for which per day assessments
are to be made, a one year cap is set based on the estimated
time of the Agency’s decision making process. This decision
also reflects the fact that TSCA §8(a) requirements are more
exposure oriented than toxicity oriented, and therefore, the
quality of the information is sensitive to time. As indicated
in the discussion on extent categories, exposure Information
is important but one company’s failure to report may not have
as much of an impact as nonreporting of toxicity information
because the exposure information is used in the context of total
exposure. Therefore, these violations are capped at one year.
A chart Is provided in Appendix I which indicates the caps
per violation and their maximum assessments. Caps refer to
maximum penalties for each separate violation; they are not
cumulative caps for multiple violations.
Determining Plumber of Violations
The number of vlolatibns depends on the requirements which
are in each rule. Multiple violations are to be assessed when-
ever more than one rule Is violated and for each violation within
a rule. TSCA §8(a) Inventory violations are assessed for each
chemical for which there Is a violation-. The Inventory Update I
rule requires reporting for each chemical and for each site.
Therefore, TSCA §8(a) Inventory Update violations are assessed
per chemical per site.
Violations of CAIR and PAIR are assessed per chemical per
site. TSCA §8(a) Chemical Specific Rules violations depend
on the information required by the rule. If the rule requires
site specific information, then violations are assessed per
chemical per site. If the rule requires aggregate information
for each company, then violations are assessed for each chemical
not reported/otherwise in violation.
ISCA §8(c) violations are determined depending on the viola-
tion. TSCA 8(c) ufailure to keep records violations and “failure
to report” violations are assessed per allegation not maintained/
reported. This is because the omission of any allegation may
Impact the Agency’s decision making process, especially If there
Is significant underreporting of allegations. However, a “failure
to keep records as required under TSCA §8(c) is assessed per plant
site because these violations Involve files not maintained as
prescribed but for which the information Is available. An alle-
gation consists of each report (I.e., one or more pieces of paper)
whereby an lndividual/ group submits an allegation to a company.
If one person alleges that six chemicals produced ten effects
In the same report, and the company fails to file the allegation,
this is assessed as one violation. If two persons file separate
reports regarding the same health effect, and the company does
not file the allegations, this constitutes two violations. If
000 03

-------
-26-
a union files a report for 100 persons regarding an allegation,
and the company does not file the allegation, this is assessed
as one violation.
• TSCA §8(d) violatIons are assessed for each required study.
The omission of a single study even If others are submitted may
have a serious impact on the Agency’s decisions regarding a
specific chemical. TSCA §8(e) violations are assessed per type
of effect per chemical not reported. Omission of one significant
adverse effect even If other effects are reported impedes the
Agency’s risk assessment.
TSCA §12 violatIons are assessed per chemical per country
per year not reported. This decision was based on the determina-
tion that the export notiftcatlon requirement Is a one-time
requirement per year for each chemical and for each country of
export. That is, the first time a chemical Is exported to a
country, t-he exporter must notify the country. Subsequent
exports of the same chemical during the same calendar year to
the same country do not require notification.
TSCA §13 violatIons are assessed per shipment per port
because the U.S. Customs regulation requires a certification for
each shipment, not for each chemical within a shipment. If the
same chemical is imported on the same day to a port In three
separate shipments, there are three violations.
Adjustment Factors
Voluntary Disclosure
The Agency considers It important to foster voluntary
disclosures of violations for ISCA § 8, 12, and 13. Most dis-
closures of TSCA §8 violatIons will be treated as late reporting
and subject to level 4 instead of level 1 penalty assessments,
which provides a voluntary disclosure Incentive. For TSCA §8(a)
Inventory violations and TSCA § 12 and 13 violatIons, explicit
reductions for voluntary disclosure are also provided. It is
Important to foster voluntary disclosure of TSCA §8(a) Inventory
violations in order to remove chemicals from the Inventory which
were placed there Illegally. Once the Agency knows of this, It
it can act to correct the violation. Similarly, if violations
of TSCA § 12 and 13 are brought to the Agency’s attention, It
can act to remedy the situation, e.g., foreign countries can
be notified or imports In violation of other sections of TSCA
can be Identified and appropriate action taken.
Also, EPA wants to encourage companies to conduct self-
audits and report violations.

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—27—
History of Noncompliance
As a further Incentive for the voluntary disclosure of
violations, the Agency has decided to forego the imposition of
penalty increases for a previous history of noncompliance in
assessing penalties for voluntarily disclosed violations.
However 1 a voluntarily disclosed violation does constitute
a history of violation and is to be used to increase penalties
for future violations which the Agency discovers.
ISCA Section 13 - Who Issues Notice of Noncompliance/Penalty
and to Whom
TSCA §13 may involve imports in one Region by an Importer
of record, who Is located in another Region and who uses a
broker. The Notice of Noncompliance/Penalty Is to be issued
to the importer of record, not the broker, and by the Region
In which the importer of record is located. This Is consistent
with the Inspection Guidelines.
This decision was made for several reasons. If a TSCA §5
inspection Is conducted at the importer of record’s business,
and there Is a chemical which has been imported Into three ports
In three other Regions and which is not on the inventory, It is
more efficient to issue a Civil Complaint for the one ISCA §5
violation and three TSCA 13 violations than to Issue four sep-
arate Civil Complaints In four Regions.
A second reason pertains to the location of the hearing.
If one Region Issues the complaint to an importer of record in
another Region, there is a problem of travel , both in terms of
time and money, since the hearing will likely be held In the
Region where the Importer of record is located.
A third reason deals with the tracking of Notices of Non-
compliance between Regions in order to know If a company has
received its first TSCA §13 NotIce of Noncompliance and Is
therefore subject to penalties for subsequent violations.
000105

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APPENDIX 1
CAPS FOR PER DAY VIOLATIONS

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APPENDIX 2
EXAMPLES

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CAPS FOR PER DAY VIOLATIONS
ALL CAPS ARE PER VIOLATION
TSCA §8(e ) --No Caps
ISCA §8(d )
Nonreporting/False Reporting
Major, level 1 — $278,333 — 5 yr. cap
Significant, level .1 — $120,322 — 3 yr. cap
Minor, level 1 — $15,111 — 1 yr. cap
Late Reporting
Major, level 4 - $111,333 — 5 yr. cap
Significant, level 4 - $42,467 — 3 yr. cap
Minor. level 4 — $3,022 — 1 yr. cap
TSCA 8(c )
Nonreporting/False Reporting — 1 yr. cap
Significant, level 1 — $51,378
Late Reporting — 1 yr. cap
Significant, level 4 — $18,133
TSCA §8(a) Chemical Specific rules
Nonreporting/False Reporting — 1 yr. cap
Significant, level 1 — $34,189
Late Reportlng•— 1 yr. cap
Significant, level 4 — $12,067
000107

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—2—
TSCA §8(a) Inventory and Inventory Update
Example 1 — A company fails to report a chemical on the
TSCA Inventory. EPA discovers the violation. Failure
to report, level 1, significant, one—time penalty.
Failure to report — $17,000
Example 2 — A company fails to report a chemical on the
TSCA Inventory. The company Is bought by another company
who, upon checking records, discovers the failure to report
and immediately notifies the Agency. Failure to report,
level 1, sIgnificant, one—time penalty.
Failure to report — $17,000
Voluntary Disclosure Policy — 50% reduction of penalty.
Amended Penalty - $8,500
Example 3 - A company fails to report 1 chemIcal at 4 dIf-
ferent sites for the Inventory Update. The company Is bought
by another company who, upon checking records, discovers the’
failure to report and Immediately notifies the Agency. Late
reporting, level 4, signIficant, 4 counts, one—time penalty.
Late reporting, 4 counts — $24,000
TSCA §8(c )
Example 1 - A union contacts EPA complaining that they
submitted 1 report to the company regarding health effects
to 10 workers due to their exposure to chemical X. The
report was presented to the company In accordance with the
rule, and the union provided acknowledgments of receipt by
the company. EPA requested the company to provide all
allegations of health effects due to exposure to chemical
X. The company failed to respond. EPA Inspected the com-
pany’s TSCA §8(c) fIles six months later and found none.
Failure to keep files, level 1, signifIcant; and failure to
report, level 1, signIficant.
$17,000 + $17,000 + 180 X $17,000 = $51,000
180
Failure to maintain a file $17,000
Failure to report (per day penalty) $34,000
181 days ________
Total 51,O00

-------
—5..
Example 5 — A company submits a list of studies known to
them but not in their possession. The Agency discovers that
the company failed to list a study they had knowledge of.
Failure to report a study the manufacturer knows of but is
not in his possession, level 2, major, one day assessment,
‘no per day penalty. $20,000
TSCA §8(e )
Example 1 —
time period
violation.
assessment —
A company failed to report a spill within the
prescribed in the policy. EPA discovers the
Failure to report, level 1, major, one—time
$25,000
Example 2 - kcompany failed to report a spill within the
time period prescribed in the policy. The company reports
their failure to EPA a year after the spill occurs. Late
reporting, level 4, major, one—time assessment — $10,000
Example 3 — A company fails to report a study showing human
health effects. EPA discovers the violation. Failure to
report, level 1, major.
Discovered after 361 days —
$25,000 + 360 X $25,000 = $325,000
30
Discovered after 1,081 days —
Discovered after 3,601 days —
$325 ,000
$925,000
$3,025,000
Example 4 — A company fails to report a study showing animal
effects not previously reported. The company later submits
it to the Agency. Late reporting, level 4, signifIcant.
Reported after 361 days —
$6,000 + 360 X $6,000 = $78,000
30
$78,000
Reported after 1,081 days —
Reported after 3,601 days -
$222,000
$726 ,000
000113

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—6—
Example 5 — A company submits a study to EPA showing
new animal effects. An inspector conducting an inspec-
tion of the company later discovers reportable information
which was omitted from the study. False reporting, level
1, signIficant.
Di scovered after 1,825 days — $1,050,600
$17,000 + 1,824 X $17,000 $1,050,600
30
Discovered after 365 days — $223,267
Discovered after 3,650 days — $2,084,767
Example 6 — A company fails to submit human health effects
information which is later characterized by the Agency as
showing a potential Imminent hazard. EPA discovers the
violation 90 days after the report was due. Failure to
report, level 1, major. Potential Imminent hazard finding,
$25,000 per day penalty.
$25,000 X 90 $2,250,000
EPA discovered the same violation after one year.
$25,000 x 365 $9,125,000
EPA discovered the violation after one year and the company
presents credible evidence that exposure ceased after 90
days of the due date of the report. The penalty Is calculated
as an imminent hazard for 90 days and as a reduced per day
for the TSCA §8(e) failure to report for the period thereafter.
$25,000 X 90 $2,250,000
275 X $25,000 = $229,167
$2,250,000 + $229,167 • $2,479,167
TSCA §12
Example 1 — An exporter which has received no previous TSCA
§12 Notice of Noncompliance exports 30 chemIcals to 30 coun-
tries with no notifications. Failure to notify. Notice of
Noncompliance.

-------
—7—
Example 2 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports one chemical
to one country 30 times during one calendar year with no
notifications. Failure to notify, level 4, signIficant. —
6 ,000.
Example 3 — An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports one chemical
to one country 30 tImes during one calendar year, notifying
EPA that 5 shIpments had already occurred. Failure to notify,
level 4, significant, voluntary disclosure, more than 30 days
since discovery, 25% reduction. — $4,500
Example 4 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violatIon exports the same
chemical tO 30 countrIes with no notifications within the
same year. Failure to notIfy, 30 counts, level 4, signIfi-
cant. $180,000
Example 5 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 vIolation exports the same
30 chemicals to 30 countrIes with no notifications within the
same year. Failure to notify, 900 counts, level 4, signIfi-
cant. - $5,400,000
TSCA Section 13
Example 1 - Company Imports a chemical with no certification
and which is otherwise in compliance with TSCA. Failure to
certify, level 4, signifIcant.
First time violation: NON
Second time violation: $6,000
Example 2 - Second time violator Imports a chemical which is
otherwise In compliance with TSCA at 3 ports on the same day
but has no certification or an Incorrect certification.
Failure to notify, level 4, signifIcant, 3 counts — $18,000
Example 3: Second time violator Imports 3 shIpments of a
chemical which Is otherwise In compliance with TSCA on the
same day to the ‘ame port. Failure to notify, level 4,
significant, 3 counts — $18,000
Example 4 — Second time violator imports 30 shIpments which
are otherwise in compliance with TSCA but lack a certification.
Import may be to same port or different ports. Failure to
certify, level 4, signifIcant, 30 counts. $180,000
000! 15

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D

-------
Information Gathering
I1C Recwnmendaiions
§Se Submissions
§21 l u iisions
Literature Se.ir bes
4
Published Data
PAlR (ITC),
§8a Reports IIUR
§8d (ITC)
Problem
Characterization
Drop
or
§4 Test Data
Negotiated Test Data
NTP Test Data
§Sa Repor’sr CAIIL. IIJR.
Chcm-Spc iIii
Drop
or
CALR. IUR.
§8a Reports Chem.Spccific
8&1 Reports
§Se Submissions
§5 SNUIL,
§tkl Reports
§8c Call Ins
§Se Submissions
w
Risk Analysis/Risk Management Process
7
Entry
Review
I
I
Risk
Assessment
7
Drop
or
Risk
Management
r
ItLII-r
lLkr Re(er

-------
E

-------
,4 eg ,/i h
TOXIC SUBSTANCES CONTROL ACT (TSCA)
PL94-’-469
CANDIDATE LIST OF
CHEMICAL SUBSTANCES
VOLUME I
SUBSTANCE NAME SECTION (PART 1)
T’”’ ” “i”
APRIL 1977
TSCA INVENTORY
(On Microfiche)
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF TOXIC SUBSTANCES
WASHINGTON D.C. 20460

-------
PREFACE
The Toxic Substances Control Act (TSCA), Public Law 94-469, re-
quires the U.S. tnvironmental Protection Agency (EPA) to comnile, keen
current, and publish a list of each chemical substance which is manu-
factured, imported, or processed in the United States. Chemical sub-
stances not appearing on the inventory will be considered new chemical
substances and will be subject to review by EPA, under the nremanufac-
turing notification provisions of TSCA, prior to their manufacture or
processing for comercial purposes.
Using the authority of Section 8 of TSCA, EPA intends to comDile
the inventory from reports prepared and submitted to EPA by manufac-
turers and processors of chemical substances. On March 9, 1977, EPA
published in the FEDERAL REGISTER (42 FR 13130) proposed rules and draft
reporting forms for compilation of the inventory. These rules are
scheduled for promulgation In final form by June 30, 1977.
Each chemical substance or category of substances which appears on
the inventory will be listed with a Chemical Abstracts Service (CAS)
Registry Numbers In the near term, these numbers for specific chemical
substances should simplify both the reporting and compiling of such
substances for the Inventory. Eventually, these numbers may serve to
index additional information concerning each substance in a comouter-
based data retrieval system.
The following TSCA Candidate List of Chemical Substances prepared
by the Chemical Abstracts Service contains over 30,000 chemical sub-
stances with their CAS Registry Numbers. The puroose of the Candidate
List is to assist manufacturers and processors in identifying chemicals
which they must report. Although the list does not Include every chem-
ical substance manufactured or orocessed for conii ercla1 purooses, It is
quite comprehensive and contains all the information needed to identify
those substances contained therein for the Inventory. For chemical
substances not identified on the TSCA Candidate List, a manufacturer
must provide a detailed description of each substance so that an apnro-
priate CAS Registry Number may be assigned. Manufacturers and proces-
sors are therefore encouraged to consult carefully the Candidate List to
simplify compliance with the EPA inventory reoorting requirements.
Published in three volumes, the TSCA Candidate List has been
arranged Into four sections, each of which provides a different means of
locating chemical substances. Volumes I and II contain the Substance
Name Section, an alphabetical listing of systematic chemical names and
synonyms for substances on the Candidate List. Volume III has three
parts. The Formula Section orders substances with known chemical con-
stitution by molecular formula. The CAS Number Section lIsts substances
by CAS Registry Number. Finally, the Chemical Substances of Unknown or
Variable Composition, Complex Reaction Products, and Biological 1ateria1s
(UVCB) Section presents chemical substances that do not have specific
molecular formula representations. This Section is organized In subsets

-------
— 11 —
of closely related substances. The hierarchical listing of subset
headings printed as a preface to the UVCB list should help manufacturers
locate chemical substances included under one or more of the subset
headings of the list. Only those substances listed with CAS Registry
numbers and not the subset headings are Candidate List chemical sub-
stances.
EPA recognizes that some of the chemical substances listed in the
Candidate List could be more precisely described. Specifically, some of
the entries in the UVCB Section such as asbestos, tar, or humic acids,
could be refined. As stated in the proposed inventory reporting regula-
tions, EPA intends to revise any category on the inventory as appropri-
ate based on information obtained through Section 8 of TSCA or other
sources. Also, the categorization of chemicals for compilation of the
inventory in no way prejudges how chemicals might be categorized for
implementing other sections of TSCA.
A draft Guide to the Use of the TSCA Candidate List has been
published in the FEDERAL REGISTER. The guide explains the meaning of
the various informational entries contained In this list, further de-
scribes the organization and content of each section of the list, and
elaborates on instructions for reporting chemical substances for the
inventory. EPA has solicited coninent concerning the clarity o.f the
guide and plans to make any necessary revisions and publish it along
with final inventory reporting regulations in June 1977.
Finally, some minerals which appear in the TSCA Candidate List of
Substances a’so are included in Appendix A of the Candidate List. EPA
published in the FEDERAL REGISTER a list of “Minerals Currently Under
Consideration for Inclusion in Appendix A of the Candidate List.’ Based
on coments received on this list, EPA will publish Appendix A with the
final inventory regulations In the FEDERAL REGISTER. Consistent with
the proposed regulations, minerals specifically designated in Appendix A
of the Candidate List need not be reported as they will be automatically
included on the inventory.

-------
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TOXIC SUBSTANCE CONTROL AC! CI’SCM
CHEMICAL SUBSTANCE INVENTORY
VOLUME I
TSCA INVENTORY: 1985 EDiTION
Jinuary 1108
U.S v ,vmminta1 PrcCmc c Agi cy
om . i & b sacus
Wh ngt , D.C. 10490

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TOXIC SJBSTANC CONTROL AC’F (‘iSCA)
CHEMICAL SUBSTANCE INVENTORY
TABLE OF CONTEN’IS
VOLUME I
TSCA INVENTORY: 1985 EDITION
INTRODUC1’ION
ELIGIBILITY CRITERIA FOR INCLUSION OF CHEMICAL SUBSTANC ON THE INVENTORY
REGULATORY ACTIViTY SINCE PUBLICATION OF THE INiTIAL INVENTORY
• Testing of Chei , ir 1 Substances and Mixtures Under Section 4
• Premanufacture Notification Rule
• Section 6(3) Orders/Section 5(0/6(a) Rules
• Significant New Use Rules
• Ru!. for Partial Updating of the TSCA Inventory Dets B . .. Production and Sit. R.porta
• Limited Exemption from Premanufacture Review for Certain Polymer,
• Limited Exemption from Premanufacture Review for Certain Low Volume
USE OF THE INVENTORY
• Element, of Identification
• Description of the Inventory and
• Using the Indices to T ixs’ea Chmiiua I Substanc. on the Invuntry
INVENTORY SEARCH ASSISTANCE
CHANGBS TO INVENTORY LISTING& CORREC’flONS DEIZI’IONS, AND CAB REGISTRY
NUMBER UPDATE
CHEMICAL SUBSTANCE IDENTITIES
APPENDIX k Chamfr 1 Substance Definition.
• SDA Substance Identification Procedure
APPENDIX B: Confidential Chemical Substance Identities
• Guidelines for Creating Prupca A Generic Names for Confidential u miui 1 Substance Identities for the
ISCA Inventory

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VOLUME II
SUBSTANCE NAME INDEX
USER GUIDE TO THE SUBSTANCE NAME INDEX
SUBSTANCE NAME INDEX
VOLUME III
SUBSTANCE NAME INDEX
USER GUIDE TO THE SUBSTANCE NAME INDEX
SUBSTANCE NAME INDEX
VOLUME 1V
MOLECULAR FORMULA INDEX
USER GUIDE TO THE MOLECULAR FORMULA INDEX
MOLECULAR FORMULA INDEX
VOLUME V
UVCS INDEX, SECTION 4 RULE INDEX, SECTION 6(e) Ordur/SECTION 5 ( 1) 1 6 ( a) RULE
INDEX AND SIONIP CANT NEW USE RULE INDEX
USER GUIDE TO THE UVCB INDEX
UVCB INDEX
USER GUIDE TO THE SECTION 4 RULE INDEX SEC’lION 4 RULE INDEX
USER GUIDE TO THE SECTION 5(e) ORDER/SECTION 5 (0/ 6 (a) RULE INDEX
SECTION 5(e) ORDER/SECTION 6(0/6(a) RULE INDEX
USER GUIDE TO THE SIGNIFICANT NEW RULE INDEX
SIGNIFICANT NEW USE RULE INDEX

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TSCA CHEMICAL SUBSTANCE INVENTORY: 1985 Edition
The Toxic Substances Control Act (TSCA) Inventory
lists over 63,000 chemical substances (as defined by
TSCA) whose manufacture, importation, or processing for
commercial purposes in the United States has taken
place since January 1, 1975.
The printed inventory is a 5—volume set containing
TSCA Inventory substances listed by Chemical Abstract
Service (CAS) Registry Numbers or Accession Numbers
(Volume I). Indexes are provided for Substance Names
(Volumes II & III), Molecular Formulae (Volume IV) and
Substances of Unknown or Variable Composition, Complex
Reaction Products and Biologicals, and Substances Subject
to Regulatory Action (Volume V).
Those who wish to purchase 5—volume sets should
fill out the attached order form and mail it to:
Superintendent of Documents, Washington, DC 20402.
9 P iltc t iEbq
1rgb3i, D C
(372) 7 38
[ j Yes, please send ne _____ sets of the 5-volune TSC Inventory: 1985
Edition at $161.00 per set for the U.S. and Canada; and $201.25 for anycne outside
of the U.S. or Canada. (S/N 055—000-00254—1)
The total c t of iw order is $ _________
(P1 çe x st.)
_______________________ PIA d k u tJt d of
( )
o
& rktorthrt of Iboj uts.
I] 1 r1.41t t. J I I I I I I 1—0
o v - -- -
mIImujliIiiijIn
__________ (Sig tr
(aI r’, a d Zip )
( eiLt Catd tate)

-------
a
SEARCH OF COMPLETE TSCA INVENTORY
EPA .RegIon
0CM Received
ER No. ____________
Priority Date ______________ _________________________________
Inspector
Phone Number
Certified Statement DYES ENO CAS No. -
SPECIAL NOTE FOR DYES: At a minimum, you must provide a valid
chemical name (not trade name) andfor chemical structure.
Substance is not a Cotour index name
D Substance is not a hydrate
___________________________________________________ .
ChEMICAL NAME
S I
MOLECULAR FORMULA
T _
STRUCTURE
USE
COMPANY NAME
INVENTORY REFERENCE
(Inventory Form No.) -
‘ . • — .. —— -
IMD RESPONSE SECTION . ... - .•.
• . .
: _.
Search completed on _________ ... Q-Noton Mory-- -- .
Date placid Oi l Inventory invalid CAS number - -
PMN I (if applicable) Valid CAS number Is not equIvsIe! ‘
Notice of commencement to submitted chemical

-------
CERTIFIED STATEMENT
I, Linda A. Travers, am Director of the Information
Management Division in the Office of Toxic Substances. The
Information Management Division is responsible for maintaining
and updating the list of chemical substances compiled under
Section 8(b) of the Toxic Substances Control Act (TSCA) known as
the TSCA Chemical Substance Inventory (TSCA Inventory). I
certify that the substance identified below has/has not completed
the Agency’s Premanufacture Notice (PMN) review process and is/
but is not included in the TSCA Inventory as of the date specified.
PMN Case Number:
PMN Submitter:
CAS Registry Number:
ecific Chemical Name:
Date PMN Received for Agency Review:
Date PMN Review Period Expired:
Date Substance Included on Inventory:
Date Notice of Commencement Submitted to Agency:
Date Notice of Commencement Received by Agency:
as
Linda A. Trav.rs, Director
Information Management Division
ass a4
Date

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F

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,tD 3?4
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
4 L
J1j4 51989
orrlct or
- PCS1ICIDCS AND TOXIC SUSSTANCCS
MEMORANDUM
SUBJECT: Enforcement Request (ER) Number 89-100
FROM: ,Joseph J. Merenda, Director
44 ” Existing Chemical Assessment
TO: Michael Wood, Director
Compliance Division (EN-342)
This memorandum is in response to a request from Sherry
Sterling of your staff. Ms. Sterling has requested a
certification identifying chemicals involved in an enforcement
action against Alcolac Inc. which may have been inadvertently
included in the final Preliminary Assessment Information Rule
(PAIR) published June 22, 1982 (47 FR 26992).
Of the nine chemicals involved in the case, seven are in the
category described above. The CAS numbers for those seven
chemicals are:
96—05—9 105—16—8 818—61—1
868—77—9 2426—54—2 2867—47—2
3775—90—4
Please note that my staff believes one of the CAS numbers listed
in the request was invalid. Our assumption is that CAS No. 868-
77—8 should be listed as 868—77—9.
Following an in-depth review of OTS files and interviews
with numerous current and past OTS staff, it has been determined
that 53 chemicals were listed inadvertently on the June 1982
PAIR. I have attached a list of the chemicals highlighting (in
green) those 53 chemicals inadvertently listed. I am requesting
that 0CM not inspect nor take any enforcement action for
violations of the final PAIR j such an inspection or action is
limited to one or more of the inadvertently listed chemicals. In
addition, I request that previous violations of the 1982 PAIR
involving the 53 chemicals not be used in computing penalties for
future TSCA violations.
Please notify Bill Lee (382—3465) of my staff if you have
any questions concerning this matter.
Attachment
cc: Sherry Sterling (EN—342)
Rose Burgess (EN-342)
Vincent Giordano (LE-134P)

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Existing Chemical Assessment Division
Comprehensive Assessment Information Rule (CAIR)
Using the authority provided in section 8(a) of the Toxic Substances Control Act (TSCA), the Existing Chemical
Assessment Division gathers chemical-specific information from manufacturers, importers, and processors of
chemical substances. ECAD has developed CAIR to make this effort more efficient and the collected information
more useable. Anticipating the questions of potential users, the Division has prepared the following answers.
What is CAIR?
CAIR is a standardized, yet flexible, approach to gathering information on chemicals as they are defined
under TSCA. It consolidates a comprehensive set of reporting provisions and questions into a model rule.
Moreover, it provides a list of questions from which reporting requirements can be selected for various chemicals.
Responses can be tailored to only those items of interest to data users.
Who can use CAIR?
The universe of potential users is broad. It indudes EPA and other Government offices needing information
from industry to support risk identification, risk assessment, and regulation of chemical substances. It
also includes other organizations that are involved in efforts related to health and/or the environment
and that require information already available on a CAIR centralized data base.
What are the advantages of a model rule?
CAIR is designed to simplify and improve data-gathering procedures: As a model rule, it reduces duplication
within the Government and saves the resources required to develop and implement chemical-specific rules. It
also lowers industry’s reporting costs by decreasing the time needed to become familiar with separate rules
for each chemical. In addition, CAIR is comprehensive in the kinds of information it can make available, as
indicated below.
What types of information can be gathered through CAIR?
CAIR provides a mechanism to collect chemical-specific information on a wide range of subjects, including
the following:
• Identification and characterization of manufacturers, importers, and processors
• Production volumes, trade names, and categories of uses
• Chemical composition and physical/chemical properties
• Environmental release and environmental fate
• Market values, production costs, and availability of substitutes
U.S. Environmental Protection Agency
Office of Toxic Substances

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Page 1 of 6
TSCA ABSTRACTS
INVENTORY UPDATE RULE (IUR) (40 CFR Part 710]
Effective Date: - August 25, 1986
Closing Date: December 23, 1986
Authority: Section 8(a) of TSCA
Failure to comply is a violation of Section 15 of TSCA and will subject violatorS
to penalties of TSCA Sections 16 and 17.
Initial reporting period: most recent complete corporate fiscal year preceeding
August 25, 1986.
Recurring reporting: Eveiy 4 years for as long as the rule is in effect.
Summary of Rule: Manufacturers and importers must report current data on
production volume, plant site, and site-limited status (not distributed for
commercial purposes as a substance or part of a mixture or article outside the
plant site) for certain chemical substances included on the TSCA Chemical
Substances Inventory.
WHO MUST REPORT (Section 710.28]: A person is subject to this rule if he has
manufactured or imported a reportable substance in the United States at any
time during the most recent complete corporate fiscal year prior to August 25,
1986. (See EXEMPTIONS . page 4.)
REPORT FORM [ SectIon 710.39 (d)j: Partial Updating of TSCA Inventory
Database Production and Site Reporr Form U (EPA Form 7740-8).
REPORTING VOLUME LIMITS : A chemical is subject to reporting if production
(manufactured or imported) is more than 10,000 lbs (4,540 kg) at one site. Low-
volume substances with an annual site-specific priduction volume (or total
amount imported) of less than 10,000 lbs are excluded from this rule.

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Page 2 of 6
REPORTABLE SUBSTANCES (Section 710.25]: Those that were initially
reported for the TSCA Chemical Substances Inventory, as well as substances
added to the Inventory following TSCA Section 5(a) PMN review and the
Agency’s receipt of an NOC of manufacture or import. (See EXCLUSIONS ,
page 3.)
INFORMATION TO BE REPORTED (Section 710.32]: Chemical identity, pIa t
site, annual production volume, and site-limited status. Also required is name,
address, and telephone number of technical contact.
Chemical IdentIty: Chemical name (not trade name) and CAS
Number. For confidential substances with no CAS Number, an EPA-
designated Accession Number should be provided instead. If submitter
cannot identity a particular substance by CAS Number or Assession
Number, then PMN number, original Inventory Reporting Form Number,
Bona Fide DCN, or TMEA number may be used.
Plant site: Specific plant site name and address. Corporate HO,
business, or POB addresses are not acceptable. Submitter must also
provide a D&B Number for each reporting site.
Production Volume: Quantities must be reported in pounds.
Quantities must be accurate to the extent that the information is known or
reasonably ascertainable by the submitter, or two significant figures
( 10%). Importers may report volume by plant site or as the total quantity
imported by the company.
Sits-limited Status: Whether substance is distributed for commercial
purposes outside the site. Imports are not site-limited.
RECORDKEEPING (Section 710.37]: Reporters are required to maintain
records that support the information in the submission. Records must be kept
for 4 years beginning with the effective date of each reporting period.

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Page 3 of 6
Records required include those that show the production volume, plant site, and
site-limited status of each of the substances reported. If a substance is not
reported because its site-specific annual production is less than 101000 lbs.,
volume records must be maintained as evidence to support a decision not to
submit a report. Persons who are exempt as small manufacturers are not
required to keep records.
DUPLICATIVE REPORTING (Section 710.35]: Any person who has submitted a
report under a Section 8(a) rule within 1 year of the start of the reporting period
(i.e. August 25, 1985 - August 25, 1986), is not required to report again on the
manufacture of that substance at that site.
When two or more persons are involved in a particular import transaction, only
one of them needs to submit a report. If no report is submitted, each is liable for
failure to report.
EXCLUSIONS (Section 710.261: Excluded from the reporting and record-
keeping requirements of this rule are the following: POLYMERS. INORGANICS.
MICROORGANISMS . and NATURALLY OCCURRING CHEMICAL SUB-
STANCES . Many substances excluded from the rule are labeled with a special
NXUN flag in the 1985 edition of the Inventory. However, substances other than
those labeled with the XU flag may also be excluded from the rule.
Polymers may be identified by the presence of polym, alkyd,’ or oxylated in
the CAS Index or Preferred Nomenclature. Polymers may also include
siloxanes and silicones, silsesquioxanes, proteins, enzymes, polysaccarides,
rubber, or lignin.
Inorganics do not contain a carbon atom, or contain carbon only in the form of
carbonato (.C0 3 J, cyano (-CNJ, isocyano (-NC], cyanato (-OCNJ, or isocyanato
(-NCO] groups, or the chalcogen analogues of these groups.
Microorqanisms are bacteria, fungi, yeasts, and eimeria.
Calcogen - see page 610, definitIon.

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Page 4 of 6
Naturally occurring chemical substances are chemical substances which are
naturally occurring and which are unprocessed or processed only by manual,
mechanical, or gravitational means, or by dissolution, flotation, or heating solely
to remove water [ 40 CFR Section 710.4].
EXEMPTIONS
1. Small Manufacturers (Section 710.29 and TSCA Section 8(a) Small
Manufacturer Exemption Rule (40 CFR 704.5(d)]. Small manufacturers
must meet one of two standards:
(1) Total annual sales, when combined with those of its parent
company, are less than $40 million. However, if annual
production volume of the chemical substance subject to reporting
is more than 100,000 lbs (45,400 kg) at a site, the manufacturer
must report production for that site.
(2) Total annual sales, when combined with those of its parent
company, are less than $4 million, regardless of the quantity of
chemicals produced by that manufacturer.
2. Limited manufacture (Section 710.301. Persons who manufacture or
import substances in small quantities for R & D or persons who import
substances as part of articles, are exempt from reporting. Persons who
manufacture substances as impurities, byproducts, etc., as described
under 40 CFR Section 720.30(g) and (h) of PMN Rule, are also exempt.
EXCEPTIONS TO EXCLUSIONS AND EXEMPTIONS
If a polymer, inorganic substance, or microorganism is the subject of a TSCA
Section 5(e) or 5(1) order, or is the subject of a proposed or promulgated TSCA
Section 4 test rule or TSCA Section 5(a)(2), 5(b)(4), or 6 rule, or is the subject of
relief granted under a civil action under TSCA Section 5 or 7, that substance Is
not excluded from the rule.

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Page 5 of 6
Section 5(a)(2) refers to the Significant New Use Rule (SNUR).
Section 5(b)(4) refers to the Administrators list of chemical substances which
present or may present an unreasonable risk of injury to health or environment
if manufactured, processed, distributed in commerce, used, or disposed of.
Section 6 refers to rules prohibiting or limiting manufacture, processing, dis-
tribution in commerce, use, or disposal of chemical substances which present
an unreasonable risk of injury to health or the environment.
OCM’s onontv order for IUR violations :
1. Failure to report Level I Violation
2. False reporting Level 1 Violation
3. Circumvention of Section 5 PMN Violation/False Report
reporting
4. Late reporting Level 4 Violation
5. Error letters (No response, Level 6 Violations
late response)
DOCUMENTATION
1. Document total annual sales and/or production volumes
>10,000 pounds/plant site for total annual sales >40 million
dollars, or >1 00,000 pounds/plant site for sales of $4-40 million
2. Document the corporate fiscal year
3. Document that commercial manufacture/importation occurred
4. Document claims for exemptions or exclusions. Check chemical
records against CORR list, to ensure that there are no reporting
rules for a chemical for which an exemption or exclusion is
claimed. Note that IMO will determiner whether the substance falls
within the Part 710.26 exclusions.

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Page 6 of 6
If an exclusion violation is documented during an inspection,
complete a “Search of Complete TSCA Inventory” form
Immediately upon return to NEIC and have it submitted to
MD with a request for a Certified Statement, Partial Updating of
the Inventory DataBase Rule Search and Status.
NOTE: The Inventory Update Rule [ 40 CFR Part 710] uses the
term “calcogen analog” in the section excluding inorganic
chemicals from IUR reporting (Section 710.26J. According to
Hack’s Chemical Dictionary, “calcogen’ is used in the same
context as “halogen,” and refers to the elements oxygen, sulfur.
selenium, tellurium, and polonium. From the standpoint of
excluded chemicals, take this to mean that “inorganic chemicals
do not contain a carbon atom, or contain carbon only in the form of
carbonato [ =C0 3 ], cyano (CN], isocyano (-Nd, cyanato [ -)CN], or
isocyanato (-NCOI groups, or analogs in which the oxygen is
replaced by sulfur or possibly selenium.N The most likely analogs
would be thiocyanato [ -SCN) and isothiocyanato [ -SNC].

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G

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Existing Chemical Assessment Division
TSCA Section 8(c)
Allegations of Significant Adverse Reactions
What is Section 8(c)?
Section 8(c) of the Toxic Substances Control Act (TSCA) requires manufacturers and processors of chemical
substances and mixtures to maintain records of allegations of adverse effects to human health or the environment
believed to have been caused by the chemical substances or mixtures. Any person may make such art allegation.
including an employee, a private citizen, a plant neighbor, or another company representative on behalf of
its employees. While the allegation need not be supported by scientific or medical evidence, for the purposes
of 8(c). it must establish a link between a chemical substance or mixture, a particular company’s product.
process, or effluent, and any “significant adverse reaction” experienced by the public or environment.
Manufacturers and processors are required to collect, record, file, and retain these allegations.
What purpose does 8(c) serve?
Section 8(c) of TSCA requires that a worker or consumer allegation be recognized and retained by industry.
EPA expects that individual companies will use the 8(c) records to identify problems associated with the chemi als
that they manufacture, and will subsequently take steps toward resolving identified problems.
This section also serves to create a historical record of significant adverse reactions alleged to have been caused
by a chemical substance, mixture, process, or effluent. It thus provides a means to identify previously unknown
chemical hazards and to reveal patterns of adverse effects that might otherwise either go unnoticed or go undetected
for long periods of time.
What are the 8(c) major provisions?
The final rule implementing Section 8(c) of the Toxic Substances Control Act was promulgated on August
22, 1983 and became effective on November 21, 1983. (See 40 CFR Part 717.)
Industries must keep allegations of adverse health effects filed by employees for 30 years. and keep all other
allegations for 5 years. Both written and oral allegations must be retained. EPA may inspect these records and
require submi sion of copies.
Who can use 8(c)?
ECAD can requite industry to submit 8(c) records on specific chemical substances at the request of EPA
program offices and other government agencies. In addition, other organizations may request already
available 8(c) information from a central file.
For further information regarding TSCA Section 8(c), please contact:
TSCA Assistance Office, TS-799
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 554-1404
A videotape ia also available on TSCA Section 8(c) and can be obtained by calling the above number.
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88

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FACT SHEET
Final TSCA Section (c) Pule
Records and Reports of Allegations That Chemical Substances
Cause Significant Adverse Reactions tO Health or the Environment.
Background
o Section 8(c) of the To*ic Substances Control Act (TSCA)
requires that any person who manufactures, processes, or
distributes in commerce any chemical substance or mixture’
must keep ‘records of significant adverse reactions to health
or the environment, as determined by the Administrator by
rule, alleged to have been caused by the substance or
mixture.
o Section 8(c) requires that allegations of adverse reactions
t Q the health of employees be kept for 3O ears , arid all
othe? alTegati orts be kept for five years .
o EPA may inspect these records and require submission of
copies of such records.
Purpose -
o The rule defines ‘significant adverse reacttons to chemical
substances and mixtures and estaolishes a system of
recordkeeping and reporting.
o The rule creates an historical record of significant adverse
reactions alleged to have been caused by a substance or
‘nixture. EPA can examine such records whenever a chemical is
discovered to present possible risks to human health or the
envi ronisent.
o Also, th. rule provides a means to identify previously
unknown cheiBical hazards and to reveal patterns of adverse
effects that might otherwise either not be noticed or go
undetected for long periods of time.
? fistory
o EPA proposed a rule to implement section 8(c) of TSCA. which
was published in the Federal Register of July 11, 1980 (45 FR
47008).
o Approximately leo written c3mrnents were received on the
proposal and public meetings were held in Washington, D.C.,
Newark, N.J., and Houston, Texas.

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o Allegations subject to the rule
— 30th written, signed allegations and oral allegations
are sub3ect to the rule. (A company is not required to
record anonymous allegations.) Oral. allegations must be
dealt with i one of two ways. The company can either
transcribe the oral allegation itself or it can request
that the alleger submit the allegation in written form
and sign it.
— Allegations nay be made by any person, such as an
employee, a consumer, a plant neighbor, another firm on
behalf of its employees or an organization on behalf of
its members.
— An alLegation can cite one of several causes of a
reaction including a specific chemical, a mixture, an
article containing a substance, a company process or
operation, or an effluent or other plant site emission.
o Recordkeeping Requirements
— Records must be kept for 30 years In the case of
allegations involving the health of employees: (even
if it is not the company’s own employee). All other
allegations (i.e. consumer, plant neighbor, etc.) must
- be kept for five years.
— Records must be kept at the company’s headquarters or at
a site central to their chemical operations. Records
must be retrievable by the cause of the reaction.
— The record must include the original allegation as
received, an abstract of specific information in the
allegation (see S717.15(b)(2) for specifics), the
results of any self—initiated investigation, and copies
of any further required records or reports (i.e. to 0 HA
or CPSC) relating to the allegation.
o rnspection Reporting/Conf identiality
EPA can inspect these records and require reporting. When
reporting is required, firn s will be notified y letter or by
notice in the Federal Register and will have no less than 45
days to respond. Fir ts nay claim all or part of such
submissions confidential in accordance with 40 CFR Part 2.
exemptions
o Persons not sub]ect to the rule
— Firms or sites solely engaged in mining or other solely
extractive functions are exempt from this rule.

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Fact Sheet
- TSCA Section 8(c) Rule Amendments
Background
• The rule implementing section 8(c) of the ToxiC Substances
Control Act (TSCA) was promuL jated on August 22, 1983 and
became effective Uovember 21, 1983. The rule requires
manufacturers and certain processors of chemical substances
to keep records of significant adverse reactions to human
health or the environment alleged to have been caused by
chemical substances and mixtures.
0 After promuljation of the rule, the Agency received numerous
questions, many of which involved uncertainties about who is
subject to the rule.
Pu r poses
• The basic purpose of these proposed amendments is to clarify
who is subject to the rule.
Major Provisions
° One amendment adds an exemption for ucoincidental
inanufacturers . This provisLon states that coincidental
manufacture of chemical substances is not an act that, by
itself, makes a person subject to the rule. This amendment
parallels exemptions in the TSCA Irtve tory regulations as
well as the final Premanufacture Notification (PMN) Rule.
• Another amendment clarifies what processors are subject to
the rule. The original rule language used Standard
Industrial Classification (SIC) codes 28 and 2911. as
descriptors of those processors sub]ect. The amendment
simply states that processors who are not also manufacturers
are subject If they produce mixtures or repackage chemical
subs tances.
o The preamble of the rule also answer other questions about
the 3(c) rule that were raised by commenters.
Additional Information
Copies of the amendments to the TSCA Section 8(c) rule are
available from the TSCA Assistance Office (TS—799), Room E—543,
East Tower, 40 ]. 4 Street, S.W., Washington, D.C. 20460, or by
caLling (202) 554—1404 (in Washinyton, D.C.) or toll—free 800—
424—9065 (outside Washington, D.C.). Persons with questions also
may call the above numbers.

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c:tiUn
1 r ‘ 11 w
Section (c) of P i T)ziC Substances Control Act (TSC )
requires all persons who manufacture, process or distribute
any chemical substances or ‘fixtures in commerce to keep Such
records as the Administrator iay require by rule concern1n
allegar.lons of signif ican: adverse reactions to health or :!le
environment associated witri SuCh substances or mi*tures. E
published the ISCA section d(c) rule in the Federal Register on
Auyust 22, 1983 (48 FR 3d 7d). The rule beca’ e effective on
ovember fl, 19d3.
The purpose of TSCA section 8(c) is to establish a record of
allegations of significant adverse reactions to human healtn
or the environment. Such records nay reveal patterns of adverse
effects which may be the first indication of the existence of a
serious problem meriting further Agency attention. The rule
i nplement ing TSCA section 8(c) describes the types of allegations
t be kept.
Trlis.document contains the strategy for monitoring compliance
•.‘th the section 8(c) rec r ee?ing and reporting requirements.
It discusses the regulation requirements, violations, compliance
r’onitorln; activities and the allocation of responsibilities
between I1ead uarters and trie Regions.
Pe .nrements of tne egula:io’i
Persons Subject to the ule
AH ianufacturers of chemical substances are subject to this
rule. If manufacture occurs at any site owned or controlled by a
firm, then that firm Is subject to tne rule. Addi:ionally, perso.is
whO process chemical substances are subject to the rjle if their
processor activities are described in Standard Industrial Classi•
ficatlon (SIC) Major Group 29, Chemicals aiid Allied Products, or
SIC Code 2911, Petroleum Refining. The Agency estimates that
10,000 persons are subject to the rule.
Persons Iot Subject to NQ Rule
Persons whose manufacturing activities consist of mining
or other solely extractive functions are exempt from the rule.
This exemption may include but is not limited to firms engaged
in activities described in SIC Division 9. Mining, and SIC code
2813, Industrial Gases. A processor whO is not also a manufac-

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— -
r 15 PJt 5 ahJeCt i : rile if ,f jrO c. jr ‘ ,:
1, e1gacJ (I ifl dCt1vii . S U.:scrii)e’J in SIC 2 • r s : ;
Aiierson who is s leli n1Stri utor f.i c ie’ ic l s’ t3t::e
13 exempt from the ii5 exemption r ay incl e ersu s
activities ar describe’j in the wnolesale trace SIC codes l6l
Chemicals and Allied ?roduct$, 5171 - Petroleum 3uHc Stations
and Terminals, an l72 - ?etroleum and Petroleum Products
wholesalers, Except Bul Stations ar Terminals. T.iis ooes flop.,
however, include distriOu: rs who also repackage chemicals or
mixtures. Such persons are processors.
Finally, a person whO’s a retailer 0? a chemical substance
is exempt from tnis rule unless SuCh person is also a manufacturer
or processor whO 15 s .jec: to the rule.
Allegations Subject to this Rule
Persons subject to this rule must record all allegations
of health and environmental effects, as described in trie rule,
that are received on or after NovemDer 21, 1983.
Allegations may e s i itted in writing or iiade orally. If
they are made orally, the company may either transcribe the alle-
gation or inform the alleger that the allegation may be subject
to this rule and suggest tnat the alleger submit tne allegation
in writing and sign it. (.f the alleger does not put an oral 1l
gation, such as a telephone call, in writing after a company reque1
to do so, then tne co.ii any does not have to record the allegation.
An allegation whici is su je:t to he rule is or whici
implicates a chemical in an adverse reaction in one of the
following ways:
o NamIng the specific substance.
o Naming a mixture which contains a specific substance.
o NamIng an article that contains a specific substance.
o NamIng a company process or operation in which a specific
substance is involved.
o NamIng an effluent, emission or other discharge from
activities subject to the rule.
Allegations may be made to a firm by any person, such as an employee
of the firm, a consumer, a plant neighbor, another firm on behalf
of its employees or an organization on behalf of its members.
EPA encourages firms to provide allegers with intormatiofl regardini
tne ultimate disposition of their allegations.
The types of allegations which the manufacturer or processor
must record include tnose involving the following human healti ef

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—3—
.Oti9—IdStin j “ , rSi)IL’ U ’.ia,.’ , s.: ’ s ..itI:cr
birth defect.
o Partial or co.’ 1 :: i,i airnIenc of o ui1 1 f.inctin ,
SUCh as reproø. ::iv ilSOrders, neurolo icaI d1s r r ,
or blood disoroars.
o An impairment f ur ial activities e*perienced y all r
most of the persons e*posed at one ti.i .
o An inpair nent jf nor,,al activities wri1C’ is exper1e
each time an individual is exposed.
nown hu:nan h lt effects as defined in 7l7.3(c) need
not be recorded.
Ecological effects wP,lch must be recorded include:
o Gradual or sudden changes in the composition of animal
1if or pla’ t life, including fungal or iicrobtal
organisms, in an area.
o A or ial nu . er of deatns of organisms (e.g.. fish kills).
o Reduction of t e reproductive success or the vigor of a
specs es.
o Reduction ii a;ricjlt ral productivity, whether crops or
livestock.
o Alterations in the behavior or distribution of a species.
o Long lasting or irreversible contamination of components
of the physical environment, especially in the case of
ground water, arid surface water and soil resources that
have limited self—cleansing capability.
Ecological effects which are restricted to the vicinity of
the plant site must be recorded, but effects which are the results
of spills or other discharges reported to the federal government
need not be recorded.
How and Where to Keep Records
Persons subject to this rule must establish and maintain
records at the firm’s headquarters or at any other appropriate
location central to the firm’s chemical operations. The record
of an allegation snall consist of tne following information:
o The original allegation as received (see “Allegations
Subject tO the Rjle’ on page 2).
o An abstract of trie allegation and other pertinent
information as follows:

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• 7i ,. flu.IC dfl — ; r th ! i: si : —,
the d l le Jati
— The date the : W3S r c ive j ut tn t
- The i iiplicatej s stance, mixture, article, company
process or Oper3tIOn, or site discharge.
- A description he lle er e.g., coriipan employee,”
°individual cD su -’er , ” plant nei Pibor’). f tr e
allegation involves a healtn effect, the sex and year
of birth of the affected individual Should be recorded,
if ascertainable.
— A description of the alleged health effect(s). The
description riust relate how the effect(s) became
known and the f3ute Of exposure, if explained in the
a) 1 egation
- A description f the natire of the alleged elvironmentel
effect(s), identifying the affected plant and/or animal
species, or contaiinated portion of the physical
environment.
o The results of a y self-initiated investigation with respect
to an allegation. does not req, ire persons SuDJC: : t
this rule to investigate allegations received.)
o Copils of any fjrt. ’ er required records or reports relating
to the alle;atioi. F r exa iple, if an e”iployee a1le a:i:i
results In a requirement for the firm to record t e case
on Occupational Safety and ealth Form 101 or appropriate
substitute (see 29 CFR Part 1904 for requirements under
the Occupational Safety and Health Act of 1910), a copy
of that OSIIA record must be included in the allegation
record.
Records must be retrievable by the alleged cause of tne
adverse reaction including the following:
o A specific chemical identity.
o A mixture.
o•An article.
o A company process or operation.
o A site emission, effluent or other discharge.
Allegations related t: y e Pieal : i of employee’

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.ir made hy •‘i ‘us: fur th1r i ,r. ——
ii IcmJ.3tIOflS ‘lust b ¼ or five years . If a
i Si”C S, itS SUCceSSJr lust rec n,e dflJ ‘maintain the rc jr:S
r.h.2re is no successor cse records “lust traiisulitterI )
Companies must ‘nail the records to:
Document Contr3l Officer
Office of ?estlcines and roxic Substances (TS-793?
Environmental Dr,,tection Agency
Washington, D. C. 2’J360
Inspection and Qeporti g I
Records subject to this rule must be made available for
inspection by any duly desiynated representative of the
Ad T%i fl I stra tor.
The Administrator may require that any person subject t
tnis rule Submit copies of records. Notif cation of the require-
ment to report may be made by letter or Federal Register Notice.
The notification w ifl specify a reporting period wn lch wifl be
at least 45 days Persons required to report under the rule will
submit copies of the required records to:
Document Control Officer
Office of ?est lc ldes and Toxic Substances (15—793)
EnvIronmental ?rotectlon Agency
Washington, D.C. 20460
Persons submitting records may claim that the records are
confidential business information by following the rocedjres
described in §717.18.

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H

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TSCA C8(d) ILrH . NU AP TY DATA RI PORTt C I i;LE
t. TSCA Section 4W) AuehorLty.
AdI LnLracor aiiaL requi.re any por r)n WflQ
anuf tures, rc’ci sscs, or dt trLnutc , a
suestance or rnLxture in commerece (or who rcpo os eo
do so) and whc ha possession of a study, to 9unOLt
copy of. thAt tudy to thu A c’ncy.
‘ersons chal.l sur v’tt ti t.s c)f itudie Conriuceed or
irutiated y or for ch persons.
tI. ackground.
A. TSCA ‘ (d) ueaLtn and Saf ity rule was designed to
provide unpu ’tished health and safety studies for
invesci attor s of rhe risk posed by chemcial*, and,
n particular, en support its decisions whether to
require Lndustry to test chemical, under section 4 of
rsCA.
8. Cenertc rule in CFk.
1. w .ii amend rule with eacr addition of chemicaLs.
(to o t cases the char&cats that are addec 4 to
v.e 8(i) rule are al added to the Level A
rule.)
2. The sai c (d) reporting requtrements apply tor
each cner’ical added r.o t e rule.
!U. Status.
A. 1978 finaL rule publishel; EPA sued y DOW over
certain authorities invoked in rule.
Court upholds EPA.
C. PA re—prcposed rule in L 79; final rule puriliihed ‘,n
Septeiber 2. 19a2.
I). ive subsuquent jnondi’ents . Pucri acirteti c.t cmLcaLs to
the rule. (The tatest-—Decemher 14, 1983.)
IV., Persons Required to Report.
A. anufacturero anil )rnceseors whO ruanufacturi d or
processel a suoject cher’ical, or propusod to d ao.
durtnj tn tcn— ,r ,erLnI prior to tue effective
date of thi rule.
B. OistrLOue3r ar o*empt.
C. Persons (otr.er than a manufacturer or procsSsor who
are listed as posieistnij i tudy’wiL1, ne asked to
submit tr o study vrilunt3rtly.

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Existing Chemical Assessment Division
Section 8(e) of the Toxic Substances Control Act
An Overview
Section 8(e) of the Toxic Substances Control Act (TSCA) states that “any person who manufactures, [ im-
portsl, processes. or distributes in commerce a chemical substance or mixture and who obtains information
which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury
to health or the environment shall immediately inform the [ EPAI Administrator of such information unless
such person has actual knowledge that the Administrator has been adequately informed of such information.’
Section 8(e) became effective on January 1, 1977, the effective date of TSCA.
A Section 8(e) policy statement (“Statement of Interpretation and Enforcement Policy; Notification of Substantial
Risk”), which clarified the types of information to be submitted and the procedures for doing so. was published
in the Federal Reg:ste’r on March 16, 1978 (43 FR 11110).
Since January 1. 1977, a large number of Section 8(e) notices covering a wide range of chemical toxicity/ex-
posure information have been received and given priority evaluation and appropriate followup attention by
the Office of Toxic Substances (OTS).
Upon receipt of a Section 8(e) submission. OTS prepares a status report which contains a description and
preliminary assessment of the submitted information, a statement regarding production and use(s) of the sub-
ject chemical(s), and recommendations for appropriate OTS followup actions/activities.
EPAs implementation of Section 8(e) has brought about heightened corporate awareness of potential chemical
risks, leading to voluntary company actions designed to protect human health and the environment.
Many companies have reported that in direct response to submitted chemical toxicity/exposure information.
the following types of health and environmental protection measures were initiated:
• Notification of workers, customers, and others
• Labeling and Material Safety Data Sheet (MSDS) changes
• Manufacturing, processing, and/or handling changes
• Chemical production or use halted temporarily or discontinued altogether
• Additional toxicity/exposure studies performed.
The chemical industry’s increased awareness of potential risks posed by chemicals to health and the environ-
ment is evidenced further by many voluntary industry submissions received by OTS on a “For Your Informa-
tion” (FYI) basis.
High-level scientific and administrative contacts have been established by O’I’S in each of EPA’s Program
Offices and in other Federal agencies (e.g., NIOSH, OSHA, CPSC, FDA, NTP) in order to provide a mechanism
for timely and prioritized dissemination of information concerning newly discovered hazards/risks associated
with exposure to chemical substances or mixtures. The information is also made available to all interested per-
sons via the OTS public files.
For further information regarding TSCA Section 8(e), please call:
David R. Williams (TS-778)
TSCA Section 8(e) Coordinator
Office of Toxic Substances
U.S. Environmental Protection Agency
401 M Street. SW
Washington, DC 20460
Telephone: (202) 382-3468
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88

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E(N)
Existing Chemical Assessment Division
“For Your Information” (FYI) Submissions
An Overview
The For Your Information” (FYI) submission classification system was established by EPA’s Office of Toxic
Substances (OTS) to distinguish such submissions from “substantial risk” notices submitted formally to EPA
under Section 8(e), a mandatory reporting provision of the Toxic Substances Control Act (TSCA).
Since 1977, 01’S has received FYI submissions covering a wide variety of chemical substances and mixtures
from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens.
academic institutions, State and other Federal agencies, as well as similar organizations/agencies in foreign
countries. These notices contain information on human exposure, epidemiology toxicity test results, monitoring
studies, environmental fate, and other information that may be pertinent to risk assessment.
All FYI submissions that enter the 01’S FYI document process are reviewed and evaluated in a timely manner
as part of the chemical “screening” process within the OTS Existing Chemicals Program (ECP). In recent years,
the FYI reporting mechanism has been used by 015 to solicit voluntary submissions of unpublished chemical
toxicity and exposure data for preparation of “Chemical Hazard Information Profiles” (CHIPs).
Many FYI submissions contain negative or equivocal findings that the submitting organizations wish to share
with EPA. 01’S also receives FYI notices containing positive data of the type required for submission to EPA
under Section 8(e) of TSCA. The submission of positive data to EPA on an FYI basis usually occurs because
the submitting organization does not have a TSCA reporting obligation or does not believe that the data are
reportable under Section 8(e) of TSCA. In such cases, the CT’S review of the data may result in an EPA
determination that the submitted information should have been reported formally to EPA under TSCA Section
8(e). Such a determination on the part of EPA results in a referral to EPA’s Office of Compliance Monitoring’
(0CM) for action(s) in accordance with the Agency’s TSCA Sections 8, 12, and 13 Enforcement Response Policy
(ERP).
The evaluation of and appropriate followup attention given to FYI submissions by 01’S helps in bringing
about heightened awareness of the potential hazards/risks posed by chemicals, often leading to voluntary actions
designed to protect human health and the environment. Many of the organizations providing information to
EPA on an FYI basis have reported that they have initiated the following types of health and environmental
protection measures:
• Notification of workers, customers, and others
• Product labeling and/or Material Safety Data Sheet changes
• Manufacturing, processing, and/or chemical handling changes
• Manufacture or use halted temporarily or discontinued
• Additional toxicity or exposure studies conducted.
High-level scientific and administrative contacts in each of EPA’S Program Offices and in other Federal agencies
(e.g., NIOSH, OSHA, CPSC, FDA, NTP) are maintained by 01’S in order to provide a mechanism for timely
dissemination of information regarding newly discovered hazards/risks associated with chemical substances
or mixtures. The information is also available to interested persons via the OTS public files.
For further information regarding FYI submissions, please contact:
Jacqueline Favilla (TS-778)
FYI Coordinator
Office of Toxic Substances, U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 475-8823
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88

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FYI Procøssina
IND: Information Management DivusioniOTS
CRIS: Chemical Risk Identification Sectuon/CSB
HERD: Heaith & Environmental Review DivusuoneOTS
EED: Exposure Evaluation Division
DCO Document Control Off uce/IMD
Jacqueline Favulla
FYI CoordinatoriCRlS/CSB
Telephone: (202) 475-8823
FTS: 475-8823
James F. Davr
Section HeadFCRIS/CSB
Telephone: (202) 382-3470
FTS: 382-3470
Frank D. Kover
Branch Chief/CSB
Telephone: (202) 382-3436
FTS: 382-3436
IMD
I I
I I
U I
I U
U U
I U
U U
U U
U U
. I
• U
• I
• I
Acronyms:

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çTXOa I Ce) 0? TU TOXIC SUU?MICU U ?1OL ACT TSCA)
All OVUVUW
• Section 5(e) at the Toxic Substances Control Act (TSC*)
states that ‘any person whi •anutactures. processes. or
dtitibqt,s in .rve a chs.ica.L substance or aixture
and who obtains infoceation which reasOnably supports the
conclusion that such substance or Stature l 5iOti a 5Ub
stantia.L risk of injury to health or the •n.tgo nt shall
tsdiately 1nfo A. Lnistrater of such Infot itiOl1
muss such person has actual knovl.dge that the Adoint
strator has been d.quat.ly totoceed of such infognatton.’
• S.ction SC.) bec •ff.etiws on January 1, 1577, the
effective date of TSCA.
• A Section I(s) policy statsoent (‘$tat.ftt of !nterprst$—
ties and tnforvsnt Policy, Notification at Substant aL
Risk’) vhich clarified the types of infoceation to be
subsitted and the procedures for doing 50 vii published in
the ?sdsral Register on March lI. 1575 (43 Pa 11110).
• Since January 1. 19 ”. over 550 Section SC.) notices
covering a wide rang, of cheatcal texicity/suposur.
infomatieft isv. been received and given Priority
evaluation and appropriate fallow—up attention by the
Office of Toxic Substances (OTS).
• A status r.port is prepared which contains a description
of the suhsittsd infoonatien. the OTI preliainasy assess-
oust, a statseent regarding production and iRe(s) of th•
subject chsstcsl( 5) • and rec .ndat tone for appropriate
OTS follow—up actions/activities.
• taplesentation of Section ICe) has brought about
heightened top—level corporate awareness of potential
chssica3. hazards/risks Leading to v..Lwisaiy conpany
actions designed to protect hian health and the
enviroseent.
• Many conpantes have reported that in direct respons. to
smibaittsd chsoical toxicity/exposure inforeation. the
following types of health and envirsse.ntal protection
.eaaures wore initiatedi
• Notification of workers. cuitseers, and others
• £.ah.lling and Material Salsey Data Sheet (550$) changes
• nanufacturing, processing, and/er handling enanges
• Che.ical application/use discontinued
• Additional toxicity/exposure studies perfessed
C ics1 production haltsd/discontinuid
• The chtcal. industry’ s Increased awareness of potential
hasaFds/etsks posed Dy chicals to health and/or the
enwizoseese is further evidenced y over 400 voluntary
industry suonissions received by OT$ on a ‘Par tour
Info ation (PT!)’ basis.
• Nigh level scientific and tnistrative contacts have
been established by OTS In each of DA’s Progras Offices
and in other ?sdersl agencies (e.g.. MZO1I. 035*. CPSC.
FDA. MC !. etc.) in order to provid, a uschanlm for tinely
and prioritized dissination of Infosustion concerning
newly dis ersd haxards/risks associated with exposur, to
cflseicsL s tances or •iztufls.

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1. Ovcr ’:ic.i
Section C(e), a self-i .p1crn2n?inr provision of the
Toxic Sub;ta ’ccs Control t (i C ) went i.itu effect on
Januery I, l 77. On arch 18, 1 8, the nviron ,:enta
Protection Agency (EPA) pubhshed a “Statement, of triterpre-
t tion and Enfor:erieit c1ic ’ .,ti lch reflects the Agency’s
current posh ori rcgardin the reluirements for cori lia,ice
with §8(e).
The major o ject1ve of §3(e) aid the “Policy Statement’
i to ensure that in ’jrration which reasonab’y supports a
onCiu;ioi that s st ia risk is sscciaLed :ith a
chcini:al suhs a”ce or s ro’ ght to ErA’s attc’i:1 n
i;!%r:tcdiately upo’i discovery rather than upon request by th
A ;cncy. t.lthough recei t of ‘s bs n ia1 risk ” infor ticn
by thc Agency does not necessarily tr gger iinmedi te regui-
tory control, it nay indicate the need for further evaluation
which may serve as the basis f r future control. The ohjective
of the “Policy Staterne t’ is to facilitate compliance with
§8(e) by (a) clarifying what constitites subctantial rts infor-
mation, (b) specifjing infor a: ion exempt frori the repor’.ir ;
requirei.ie1 , and by (c) outlining reporting procedurcS.

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-2—
This document contains the strategy of tfle Office of
Enforcement (OE) for enforcing ç3(e). It discusses the stat-
tory requirements as interpreted by the “Policy Statement,’
violations, priority compliance monitoring activities for
FY 81, and aflocation of responsibilities between Ieadquarter
arid the Regions.
II. Recuirements of the Rule
TSCA §8(e) requires that “any person who martu-
factures, processes, or distributes in commerce
a chemical substance or mixture and who obtains
information wniCh reasonably supports the conclu-
sion that such substance or mixture presents a
substantial ris of ln3ury to health or the envi-
ronment shall imriediately inform the Administrator
of such inforriation, unless [ tne) person has actual
knowledge that the Ad n1n1strator has been adequately
Informed of t e information.”
No formal rflemaking was required for implementation of
the provisions of §8(e), which went into effect on January
1, 1977. On September 9, 1977, however, EPA’s Office of
T x1 Substances (OTS) published proposed guidance (42 F
45362) to explain Agency policy regarding §8(e) reporting
requirements arid procedures. After considering public
comments on the proposed guidance, EPA published a “State-
ment of Interpretation and Enforcement PoHcy ” on March 6,
1978 (43 FR liflO) (hereinafter referred to as the ‘Policy
Statement”) which reflects the Agency’s current position
regarding the requirements of §8(e). The Agency is currently
codifying the Policy Statement.

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Any huS1nC S entity an. any of its employees wh are
capable of appreciatin; :. e significance of iriformatic.’ ,
concerning a Substant i 1 risk associated with a cheriical
substance or m-ixture ranufactured, processed, or diStributOd
by the entity must report :nis information to EPA. In the
case of business entites, the president, chief executive
officer, and any other officers responsible and having
authority for the orgaiiz3tlon’s execution of its §8(e)
obligations nuSt ensure that the organization reports sub.
stantial risk inforrna:i n to EPA. All employees with the
exception of those responsible for execution of a firm’s
§8(e) responsibIlities iay be relieved from liability for
failure to report direct’ 1 to EPA if they use the firm’s
Internal system for re23rtlng §3(e) Information. This
internal system is explai”ei in the Policy Statement.
Information which reasonably supports the conclusion that
a chemical substance or i xture presents a substantial risk
of injury to health or the environment must be reported to
EPA. The substantiality of the risk is based on the serious-
ness of the effect and the probability of its occurrence.
(This oetermlnatfon does not include consideration of economic
or social benefits of t’ie use of the chemical.) In the case
of a chemical causing a serious effect In a human or a group
of humans, the mere fact t”at a chemical is in commerce
constitutes sufficient ev’ nce of exposure to warrant report.
irig. Serious effects o se’ved in an nal studies or during

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-4.
the course of environ ental st dies must be reported if
there is a Potential for significant levels of exposure.
Tw types of substantial risk information must be reported
under §8(e): 1) information concerning effects of and/or
exposure to a specific chemical in a non-emergency context,
and 2) information concerning emergency incidents of environ-
mental contamination, irrespective of common knowledge about
the effects associated with the chemical(s) involved.
1) Non-emerg _ ency Chemical soecific effects whiCh
must be reported include:
a) Human health effects including any instance in
a human or pattern in a group of humans of
cancer, birth defects, mutagenicity, death, or
serious or prolonged incapacitation; any pattern
of effects or evidence in animal studies which
reasonably supports the conclusion that the
chemical can produce any of the preceding ef-
fects.
b) Environmental effects Including widespread,
previously unsuspected distribution, pronounced
bloaccumulation coupled wft potential for
widespread exposure and any non-trivial adverse
effect; any non-trival adverse effect associated
with a chemical known to have bioa-ccumulated to
a pronounced degree or to be widespread in
environmental media; ecologically significant

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-5-
chanjes in species interrelationships; facile
transfor,ati n or degradation to a chemical
having an unacceptable risk.
2) Emergency incidents which must be reported include
any environmental c3ntamination by a chemical substan-
ce or mixture which because of the pattern, extent,
and amount of conta -linatlon a) seriously threa:ans
humans with cancer, birth defects, mutation, death
or serious or prolonged incapacitation orb) serious-
ly threatens non-hu ian organisns with large scale
or ecologically significant population destruction.
The definition of “emergency incident” includes all
Incidents which would be considered ‘environmental eniergen-
des”, with the excep.ion of emergencies f3r which reporting
Is already required under the notification of spills provision
of §3fl(b)(5) of FWPCA.
“Substantial risk’ information need n3t be report-
ed if It:
1) has been published by EPA;
2) has been submitted in writing to EOA pursuant
to another authority administered by EPA as
long as It is ideritif1e 1 as a §8(e) notice;
contains information required by the “Policy
Statement”; and is submitted within time
limits required .for §8(e) notices.
3) has been p .blished in the scientific litera-
ture and referenced by certain abstract services;

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-6-
4) Corroborates well established adverse effects
already documented in the scientific literattire
and referenced in one of the specified abstract
services;
5) is contained in a notification of spills under
§311(b) (5) of the Federal Water Pollution
Control Act.
6) is information about effects that the respon-
dent knows have been brought to the A m -n•istra-
tot’s attention.
A notice of substantial risk shall be sent to the Document
Control Officer, Management Support Division, Office of Pesti-
cides and Toxic Substances (OPTS) (WH -557), Environmental
Protection Agency, Rm. E -447, 401 M Street, S.W., Washington,
D.C. 20460. A notice should:
1) be sent by a method permitting verification of
its receipt by the Agency;
2) state ft Is being submitted in accordance with
§8(e)
3) contaIn the name, address, job title, phone
number and signature of the person reporting and
the name and address of the manufacturing, process-
ing or distributing establishment with which he
Is associated;
4) identify the chemical substance or mixture includ-
ing, if known, the CAS Registry Number;

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.7-
5) stIr;iarlzc adverse cffc:’.s dc cribing the nature
and exteii f thc risk;
6) COntain the specific source of information and
a Summary and source of any supporting technical
data.
7) contain co ip1ete copies of all supporting in-
forriation. i.e., protocols, reports, surveys,
data, etc.
f. Reporting Timetable
Tyoe of substantial risk information Reportina Deadline
Any substantial risk infori,ation
which a person possesses before
January 1, 1977 and of which he is
aware_after_that_daze
May 16, 1978
.
Chem1ca specific infor iation on
non .er erçer.cy healtn or environ-
mental effects
In writing 15 days
after obtained
Erergency incidents of
envi ronmental contamination
lri iediately by
telephone
15 days later in
writing
1) [ n’or ’iat1on received orior to effective date of ISCA
Any substantial risk information possessed by a
person prior to January 1, 1977, and of which he was
aware after that date had to be reported by May 16,
1978. A person is considered to be “aware’ of:
a) any Information reviewed, or referred to in dis-
cussions and conferences prior to or after
January 1, 1971;

-------
-8-
b) any information to which the person haS eeri
alerted after January 1, 1977 including any
information concerning a chemical for wnich t e
person is presently assessing health and environ-
mental effects;
c) any pre-1977 information which becomes Subst n-
tial risk information in light of new circum-
stances
d) any other information of which the person
has actual knowledge.
2) Non-eer;ency s bstartia risk information
A person rrust report non-emergency substantial
risk infarr atioi thereinafter referred to as substantial
risk inforr .a:ion) to E’A within 15 working days of
having obtained it. A person is corsidered to have
obtained information at the time he first comes into
possession of, Knows of, or could reasonably be expec-
ted to possess or know of the information.
Supplementary information generated after a §8(e)
notification should also be immediately reported.
3) Emergency incident information
A person must report an emergency incident to EPA
Immediately by telephone giving as much of the informa-
tion requ1re t §701.93 as possiDle. A complete

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-9-
written rc por •‘ is bP su5ti tt ‘‘1 t •L! ’ ’ ii•
working days or th incidc ts 0ccurrnnc .
IT!. R ’gulated. 1 dus ry
The S(’ ) repor 1iig requlrc’flerit affectss all ri n fjc_
turers (including nlporters), processors and diStributors
of chemical subst3nces and mixtures.
The following ty’es of chemical substancc s an mixtur. s
are affected by :his reg.i1 t ion as defined in sections 3(2)
and 3(e) of 15C’.
1) those for distri ut icn in commerce, includinq tes _
market prodjcts,
2) catalysts, and in er iec1iates,
3) those fo e cl 3i,e us by :hc jnufacturer or
processor
4) products for r?sc rch and evcloprient.

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J

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PfIN MASTER RECORD
* * z
* NON—CEl * REPORT DATE: 07/13/89 NON—CB 1
* * *
PITh NUMBER: P—89—0729 PROGRAM MANAGER: DYNAMAC
DAY RECEIVED: 5/18/89 TECH. INTEGRATOR:
END OF NOTICE PERIOD! 8/15/89 FR 5CD)2:VOL! PG: DATE:
INTERIM STATUS: AS OF!
DISPOSITION: FOCUS DROP AS OF: 6/8/89
STATUS UPDATE REPORT PAGE: 1301
CHEMICAL NAME: 4_(L+,5—djhydrO_4_((5_hydzoxy_3_methyl_1_(4_sulfoph
enyi)—(1H)—pyrazol—4y1)methyiene)—3—methyi—5—oxy—1
H—pyrazoi—1—yi)ben enesu1fonic acid dipotassium sa
it
GENERIC NAME: NO
SUBMITTER NAME: Eastman Kodak Company
SUBMITTER CITY: ROCHESTER STATE! NY
DOMESTIC OR IMPORTED: DOMESTIC DATE 5(C) EXT. SIGNED:
TANDARD REVIEW DATE! DATE OF ENFORCEMENT!
SUSPEND DAY IN REVIEW PROCESS! 0
REVIEW DAY: 21
DATE OF NOC: NUMBER OF DAYS PAST REVIEW PERIOD PIANUF. COhN: 0
SUSPENSION: RESTART: DAYS IN SUSPENSION: 0
DATE VOLUNTARY CONTROLS AGREED TO:
VOLUNTARY TEST TYPE: DATE VOLUNTARY CONTROLS AGREED TO:
1) 1)
2) 2)
3) 3)
4) ‘4)
5) 5)
VOL. ACTION COMMENTS
E5 TEST TYPE! 1) SE TEST DATE! 1)
2) 2)
3) 3)
4) 4)
5) 5)

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Review Process
Review
DAY 1 PMN
RECEIPT
‘p
DAY8.12 [ 5 I
DAY 9.13
‘I,
New Chemic
Standard
Drop for some polymers
meeting select criteria(25%)
DAY 15-19
PP&4s-DROP or
0ROP OLLOW .UP (50%)
EXPOSURE-BASED
5(s) CATEGORIES (15%)
STANDAIV REVIEW
((or additional concerns)
(10%)
FOCUS
MEETING
1 TEST MARKET EXEMPTIONS GRAJIT OR DENY
r;:: POLYPER EXEIWFIK)NS GRANT OR DENY
LOW VOLUME EXEt V1IONS GRANT OR DENY
DAY 44-48 DAY 57-65
DAY 23-27 _________
WORKPLAN I el MIO cOURSEL J
MEE11NG J 4 , v _I ME_JT 1 P]
(1st DRAFT I (2nd DRAFT
DAY 38.43) 4 DAY 56-58)
REQUEST ADDITIONAL
RESOURCES TO
ADDRESS CONC (*1S
DAY 72-75
HERDiEID
BRIEFING
(Final DRAFT /
DAY 66-71) 4p(
PNMB OPTIONS
- MEETING
DAY 74-78
DISPOSITION MEETING
DISPOSITION MEETING
DROP or DROP!
FOLLOW-UP
DROP or DROP!
FOLLOW-UP
DAY 79-82
DIVISION
DIRECTORS
BRIEFING
4 !
POST-DDs (if
Regulatory
Action)
AAIOPTS
SIGNS 5(e)
ORDERSiSNURS

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• THE PREMANTJFACTURE NOTIFICATION (PMN) PROGRAM
FOR NEW CHEMICAL SUBSTANCES
I. Overview of the New Chemicals Program;
a. TSCA was enacted in 1976. Section 5 of the statute was
designed to enable the Agency to review activities
associated with manufacture, processing, use and disposal of
any new chemical substance before it enters the market p1 ce.
If necessary, EPA is empowered to take action to prevent
unreasonable risks before they occur (pollution prevention
at its basic level). This is accomplished by requiring
premanufacture reporting.
b. Section 5 does not require chemical companies to test
their new chemical substances for potential toxic effects.
Therefore, EPA’S review (and 5(e) regulatory actions) are
often conducted in the absence of data. The Agency relies
on Structure Activity Relationships (SAR) to make
predictions.
c. The program has been in place over 11 years and has
reviewed 15,000 notices. Regulatory actions have been taken
in 9% of the cases (nearly 1000 actions), no successful legal
challenges have been made to new chemicals regulatory
efforts.
d. The program continues to improve. As experienced is
gained, and data gathered, our review process has become
trimmer and swifter.
e. The volume of work is high. The number of cases reviewed
per year has generally increased steadily. The percentage
of cases regulated has increased under new policies.
II. Background on Section 5 Authorities/W.v Ch.mical Requirements;
a. Section 5 of TSCA mandates EPA to review the potential
health and environmental effects of “new chemical substances”
prior to manufacture or import.

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—2—
b. TSCA defines “New Chemical Substances” as chemical
substances not listed on the TSCA Chemical Substances
Inventory and not otherwise excluded by the regulations. The
Inventory includes chemicals in commercial production between
1975 and 1979, and subsequent chemicals reviewed in the PMN
program which have been commercially produced. The Inventory
currently contains over 65.000 chemical substances, of which,
5,000 additional substances have been added to the Inventory
through the submission of notifications of commencement to
manufacture (NOCs) after those substances had completed the
P)fl review process and were manufactured for commercial
purposes.
c. Under TSCA section 5(a), a person who intends to
manufacture or import a new chemical substance must submit
a premanufacture notice (PI’DI) to EPA at least 90 days before
commencing this activity. The term “MANUFACTURE” includes
“IMPORT”.
d. Chemicals Not Subject to P)W. Six product categories are
exempt from TSCA’s regulatory authorities: mixtures;
pesticides; tobacco; nuclear material; firearms and
ammunition; food, food additives, drugs, cosmetics, and
devices. Other new chemicals “excluded” from the requirement
to submit a PMN include:
- Substances imported as components of articles,
- Chemicals manufactured and processed (the
manufacturer must know that processing is occurring
for export only) solely for export in accordance
with section 12 of TSCA. However, if a new chemical
substance will be used in the U.S. this exclusion
does not apply,
- Chemicals manufactured as byproducts with limited
commercial purposes,
- impurities,
- Non—isolated intermediates.
e. Exemptions from PPW Review:
o New chemical substances may be “Exempted” from PMN
requirements if they are:
- Manufactured in small quantities solely for
research and development (R&D) in accordance with
all pertinent regulatory requirements,

-------
—3—
— Manufactured or imported subject to test marketing,
low volume (< 1,000 kg/yr), or polymer exemptions
granted by EPA.
o Substances manufactured in small quantities solely
for R&D:
- R&D includes synthesis of new chemical substance
or analysis, experimentation, or research on new
or existing chemical substances, including product
development activities. R&D may include tests of
the physical, chemical, production, and performance
characteristics of a substance.
- The term “small quantities” is defined in the PMN
rule as “quantities not greater than reasonably
necessary for R&D”. What are “small quantities”
in any given case would therefore depend upon the
nature of the R&D activities.
- Persons who engage in R&D for, or obtain an R&D
chemical from, a manufacturer must be notified of
any risk to health which may be associated with
the chemical. However, R&D conducted entirely in
laboratories under prudent practices are exempted
from the requirement for risk evaluation. The
notification requirements appear in the PMN rule.
- Use of any R&D substance must be supervised by a
“Technically Qualified Individual.”
- The following records must be retained: information
reviewed and evaluated to determine the need to
make any notification of risk, documentation of the
nature and method of risk notification,
documentation of prudent lab practices used instead
of risk notification and evaluation and, if an R&D
substance is manufactured at greater than 100
kgs/year, records regarding the chemical identity
of the substance to the extent known, the
production volume, and the disposition of the R&D
chemical must also be retained.
- Manufacturers and importers who distribute an R&D
substance to other persons must provide those
persons with written notification of known hazards
and of the requirement that the substance be used
solely for R&D.
- The R&D exemption is self-implementing; companies
are not required to notify EPA on exempted R&D
activities.

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—4—
o Test—Marketing Exemptions:
- Test—marketing involves distributing in commerce
- a limited volume of a chemical to specified number
of customers for a limited period of time to
determine market acceptance.
- The manufacturer must submit a test-marketing
exemption (TME) notice to EPA at least 45 days
prior to manufacturing the substance.
- EPA will grant the TME if it determines that
activities involving the substance will not present
any unreasonable risk of injury to health or the
environment.
o Low Volume Exemptions:
- This exemption is available for substances
manufactured in quantities of 1,000 kg or less per
year. Only one exemption is available per
substance regardless of the number of potential
manufacturers. Low volume substances are not added
to the TSCA Inventory; however, a separate
inventory of LVEs granted is maintained.
- The manufacturer must submit a low volume exemption
(LVE) notice to EPA at least 21 days prior to
manufacturing the substance. The notice must
include the site of manufacture, which is legally
binding upon the company.
- The manufacturer may also provide information on
exposure controls. If provided, it is also
binding.
- EPA will grant the LVE if it determines that the
• substances will not present an unreasonable risk
of injury.
o Polymer Exemptions:
- This exemption is available for certain classes of
polymers which are not chemically active or
bioavailable.
- The manufacturer must submit a polymer exemption
notice to EPA for a 21-day review. EPA will grant

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—5—
the exemption if it determines that the substance
will not present an unreasonable risk of injury.
- Unlike the other exemptions, substances subject to
polymer exemptions are added to the Inventory when
- commercial production commences.
f. The PMN form is attached for reference. P O submitters
must include information on the substance identity, uses,
estimated production volume, description of byproducts,
description of human exposure, description of disposal
practices, and health and environmental test data which are
available to the submitter at the time of submission.
Although toxicological data need not be developed solely for
the P101, it must be submitted to the extent the data are
“Known to or reasonably ascertainable by” the submitter, and
within its “possession and control”.
III. Regulating New Chemical Substances Under TBCA. Section 5(e)
and 5(f) of TSCA authorize EPA to prohibit or limit the
manufacture, processing, distribution in commerce, use, and
disposal of a new chemical substance if EPA makes the following
determinations:
a. Section 5(e) Findings:
o Available information on the substance is insufficient
to permit a reasoned evaluation of its health or
environmental effects; and
o (A) The manufacture, processing, distribution in
commerce, use, or disposal of the substance may
present an unreasonable risk of injury to health or
the environment (referred to as a “may present”
determination); or (b) the substance will be produced
in substantial quantities and (1) may reasonably be
anticipated to enter the environment in substantial
quantities, or (2) there may be significant or
substantial human exposure (Referred to as an
“Exposure-based” finding).
b. Section 5(f) Findings:
o There is a reasonable basis to conclude that the
manufacture, processing, distribution in commerce,
use, or disposal of the substance will present an

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—6—
unreasonable risk of injury to human health or the
environment before a TSCA §6 rule can be issued to
prevent the risk (referred to as a “will present”
determination):
o A section 5(f) rule , which limits activities involving
a new substance, is a section 6(b) proposed rule which
is immediately effective upon proposal. A section
5(f) order prohibits all activities involving the
substance.
o To date, EPA has issued 3 section 5(f) rules and no
section 5(f) orders, although some P)O s have been
withdrawn from review after EPA notified the
submitters that we intended to ban the substances.
c. Practices Under Section 5(e):
o To date, there have been five outcomes, depending upon
the facts of the case, when EPA makes a determination
under section 5(e):
- The company may withdraw the P Oi.
- The company may develop toxicity information
sufficient to permit a reasoned evaluation of the
health or environmental effects of the substance
prior to the conclusion of the review period
(“upfront” or “voluntary” testing). Where
exposures or releases cannot be controlled pending
testing to address EPA’S concerns, or the requested
testing is relatively cheap and not very time-
consuming, this may be the only option available
to the P1W submitter short of withdrawing the PMN.
- The company may develop and provide to EPA other
information on the potential effects of the
substance or its analogues, the potential
exposures, or both, which if accepted by the
Agency, would negate the potential unreasonable
risk determination.
- The company may, together with EPA, suspend the
notice review period, and negotiate and enter into
a section 5(e) Consent Order. The Consent Order
would permit limited manufacture, processing,
distribution in commerce, use, and disposal of the
substance pending the development of information.
A Consent Order may contain a requirement that
toxicity data be submitted to EPA when a specified

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—7—
volume of the chemical has been produced. This
production volume level is set where EPA estimates
that profits from the chemical will support the
- cost of testing.
- The company may refuse to withdraw the PI I,
negotiate a Consent Order with EPA, and/or conduct
up-front testing or develop other information. EPA
would then unilaterally develop a Proposed Order,
under the procedures in section 5(e), to ban
manufacture or import.
o Consent Orders have included one or more of the
following requirements:
- Protective equipment, including impervious gloves,
safety goggles, protective clothing, or respiratory
equipment,
- Worker Training Programs,
— Distribution Restrictions,
- Use Restrictions,
- Labels, material safety data sheets (MSDS), and
notification letters,
— Disposal limitations,
— Recordkeeping Requirements,
- A Production Volume “Testing Trigger”,
— A separate “Consent Order for Contract
Manufacture”, used in situations where the PMN
submitter has contracted out the actual manufacture
of the substance to another company.
d. Who Decides. Decisions to regulate under 5(e) are
primarily made now at the Division Director’s level (at the
DD’s meetir g). However, a number of non—controversial
decisions on clear cut risk-based cases (and exposure based
cases) are also delegated to the Focus meeting. This has
permitted the PMN review program to handle a large volume of
cases on the basis of its combined experiences. Ultimately,
the AA for OPTS is responsible for 5(e) decisions as he/she
must sign all section 5 orders.

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—8—
Iv. statistics (see attachment)
Data on Submissions:
PMN Submissions (since 1979) 12,128
ThEA Exemptions (since 1979) 487
Low Volume Exemptions (Since 1985) 960
Polymer Exemptions (Since 1985) 1,042
Total New Chemical Submissions 14,617
Data on Regulatory Actions
Section 5(e) Orders Issued 292
Section 5(f) Actions Issued 16
Withdrawn in Face of Action 565
Upfront (Voluntary) Testing Actions 205
Total Cases Regulated 1,078
(Expressed as a % of PMNs = 9%)
Notices of Commencement of Manufacturer
NOC’s Received 4,991
As % of Cases (PMNs) Reviewed 41 %
Data on Exposure—Baled Policy
Total Cases Targeted (since 2/88) 138
Cases reviewed (since 2/88) 2,421
Percentage of Cases Targeted 6 %
Prenotic. Consultations
Average Per Year 1,000

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Total Section 5 Submissions
bj ,FiccdYcr
3-
26
24-
22-
2-
000
- i.e
‘.4 ,
£
I.
b 12.
ct6’
1.1 1 1i.1
Q4. ____
0
1979 i r 1981 19 1983 1984 I9 19M 19W 19

-------
Section 5(e) Orders
LyFi.edYcr
70
U
n f l
1979 19W 1981 19 1983 1984 I9 1985 1987 1985

-------
Receipt of Voluntary Test Data
Fused Ycr
1979 I9 1981 19 1983 198* 19S 1986 1987 1986

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-9—
V. The P W Review Process. EPA developed the PMN review process
to meet the statutory mandate of TSCA §5. Any person who
intends to manufacture or import a new chemical substance is
required to provide to EPA available data on the chemical
structure, production, use, release, exposure, and health and
environmental effects. EPA utilizes an integrated approach
that draws on knowledge and experience across disciplinary
and organizational lines to identify and evaluate concerns
regarding health and environmental effects, exposure and
release, and economic impacts. The P) 1 review process is
outlined schematically on an attachment. Each P W proceeds
through a screening process to determine whether more
detailed review is required and to identify candidates for
regulatory action. EPA focuses on the relatively few new
chemicals of greatest concern—-those which are structurally
related to known toxic chemicals, and those about which
little is known.
a. Notice Intake/ Administrative Screen. At this stage,
notices are reviewed for administrative and legal
completeness. Incomplete notices, and those for which the
required fee has not been submitted, are not reviewed.
b. Initial Screen. P)O notices go through a
multidisciplined initial review designed to ascertain whether
regulatory action on a more detailed analysis is warranted.
Preliminary Chemistry, Structure Activity Relationship (SAR)
Analysis, Exposure, and Environmental Fate analysis are
conducted.
c. Use of SAR in Hazard Assessment. Given the qualitative
and quantitative limitations of the test data provided with
PP (S, EPA has had to develop innovative approaches to
characterize the potential hazards associated with new
chemical substances . The generic term applied to these
approaches is structure activity relationship (or SAR)
ana].ys.is. The major components of EPA’S SAR-based approach
to hazard analysis are the following:
— Critical review of submitted test data, if any, on
the PIaI c’ e-’ ical;
— identification and selection of potential analogues
and/or prediction of key P) 4 metabolites, followed by
critical review of test data available on these
chemicals;
— use of QSAR (Quantitative Structural Activity
Relationships) methods when available and applicable;
and

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—10—
- the experience and judgement of scientific assessors
in interpreting, weighing, and integrating the often
limited information yielded by the above hazard analysis
components.
The knowledge and experience in OTS in assessing the fate
and effects of chemicals having limited data are unparalleled
in the Agency and, to a large extent, throughout the world.
More and more EPA program offices and others are beginning
to recognize the fact that most of the chemicals confronting
the environmental assessors have at best limited data
available. This is encountered in hazardous waste sites or
environmental monitoring surveys, etc. Over the years, OTS
has come to be widely recognized for its abilities in
assessing the potential hazards of chemicals having limited
data. OTS has handled requests for SAR evaluations from many
Agency offices (e.g. ORD, OERR, OSW, OAR, ODWI OWRS, OPP, and
regional offices), other federal agencies (State, DOD) and
a number of state environmental protection programs (e.g.
N.J., Co.), and the OECD’s high volume project.
The TSCA PMN reporting requirements can be contrasted
with the European Economic Communities (EEC) “premarketing”
notification requirements established under European
Communities Directive 79/831/EEC. However, as the terms
indicate, premanufacture notification under TSCA is required
at an earlier point in the development of a chemical than is
the case for the EC’s premarket notification procedure. Many
of the information reporting requirements under the EC
directive are similar to those in TSCA with the major
difference that the EC directive requires, as a mandatory
part of the notification, a specified “base set” of health,
environmental, and physical chemical test data. Therefore,
a minimum set of test data is thus available on premarket
notification EC chemicals, whereas the hazard assessment of
TSCA P) I chemicals often starts out with fewer or no data.
d. Cases completing their initial review are brought to the
first regulatory decision meeting called Focus. At this
meeting the CCD decision maker receives reports from the
initial rev,iews prepared by each discipline and determines
whether to drop a case from review, hold it over for more
investigation (standard review) or move directly toward a
regulatory 5(e) outcome for certain standard classes of
chemicals.

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—11—
e. For chemicals which are not screened out early, the
standard review includes:
— Conducting a chemistry analysis,
- Identifying structurally analogous substances
- Searching the literature for toxicity data,
- Analyzing available test data on a substance or
analogous substances,
— Analyzing potential releases to the environment,
- Calculating exposures to workers and the general
population,
- Calculating potential concentrations in surface
waters,
- Investigating additional uses which could
significantly alter exposure.
f. Cases completing standard review are taken to the
Division Directors’ meeting for a final decision. The DD’s
meetings are chaired by CCD with senior representatives from
each division (and discipline) present. The DD’s meeting can
result in a decision to drop a case from further review, to
regulate (and require controls) under section 5(e) or 5(f),
or to “ban” the substance pending the receipt and evaluation
of “upfront testing”.
g. If a regulatory decision to impose certain controls is
reached, CCD staff communicate and negotiate with the
submitter. Similarly, if “upfront” is required, this
decision is communicated by CCD.
h. As section 5(e) orders are always “pending’ the
developaent of data, EPA rust respond when data are
submitted. This is a more frequent occurrence due to our
“triggered testing” program under which data must be
submitted prior to reaching a specific production volume.
Often, negotiated orders must be modified to reflect the
evaluation of new data.
i. Notice of Commencement (NOC) to Manufacture or Import.
An NOC is submitted once commercial production of a chemical
substance is initiated. The substance is then added to the
TSCA Inventory.

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—12—
j. Key New Chemicals Program Contacts. The following
persons are key participants in the PPOJ review process and
may be contacted for more specific information on TSCA
section 5 and the P!’flJ review process:
- Chemical Control Divisions John Melone, Director;
Lawrence Culleen, Chief, Premanufacture Notice Management
Branch (PNMB); Paul Matthai and Rose Allison, Section Chiefs,
PNMB,
- Health and Environmental Review Divisions Charlie Auer,
Acting Director; Ray Kent, Section Chief, Chemical Review
and Evaluation Branch; Vincent Nabholtz and Pauline
Wagner, Environmental Effects Branch,
— Economics and Technology Division: Mike Shapiro,
Director; William Burch, Chief, Chemical Engineering Branch
(CEB); Paul Quillen, CEB; Neil Patel, Regulatory Impacts
Branch and Paul Bickart, Industrial Chemistry Branch,
— Exposure Evaluation Division: Elizabeth Bryan, Chief,
Exposure Assessment Branch (EAB), Greg Schweer, EAB; Lynn
Delpire, EAB,
— Information Management Divisions Frank Caesar, Chief,
Confidential Data Branch; Henry Lau, Section Chief,
Inventory.
Additional P1W Contacts:
- Mary Cushmac, Prenotice Coordinator (202) 382-3745 (“Pre-
noticew questions, including when a P101 is required and the
type of information that should be included in a notice),

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—13—
vi. significant New Use Rules (SNURS)
a. Because information reported in a P O1 is not binding on
the submitter, and because section 5(e) orders are binding
only upon the PMN submitter, EPA must issue “follow-up”
regulations to effectively control deviations from its own
risk analysis or unregulated practices commenced by secondary
manufacturers. These are SNtJRS which may define certain
(disapproved) activities as “new uses” subject to reporting
90 days before they are commenced.
VII. Issues
a. New (versus existing) Chemicals Bias. To the extent the
Agency has reviewed and regulated new chemicals without
concomitantly regulating existing chemicals of like (or
greater) toxicity, it has been accused of a “New Chemicals
Bias”.
c. Confidential Business Information. Section 14 of TSCA
permits submitters of P s to claim specific portions of
their submissions to be confidential business information
(CBI). Special CBI handling procedures within OTS are
required. The implications for resources and staff are
staggering, as nearly all new chemical submissions contain
some claims of CBI.
VIII. “Hot” Topics
a. CPC 8ubstitutes. New chemical substances intended to
replace existing chemical CFS being phased out under the
Montreal Protocol will be reviewed under the New Chemical
Program. EPA will be forced to balance such considerations
as ozone depletion potential and toxicity to workers/
consumers who may be exposed to potentially more-toxic
substitutes.
b. Acrylats Agreement. As part of a long-sought voluntary
agreement, EPA and the Chemicals Manufacturers Association
recently entered into a toxicity testing program under which
cx will perform long-term chronic toxicity testing on
chemicals within a class which have proved difficult within
the new chemicals program. In exchange, EPA will loosen its
labeling restrictions while continuing to require strict
worker protection and hazard communications (MSDS)
restrictions.

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—14—
c. Pollution Prevention/Relative Risk. Evaluating chemical
related risks and making regulatory decisions before a
substance enters the market place is the best pollution
prevention strategy we at EPA have. Intervention prior to
permitting risks to occur is the basis of the New Chemicals
Program. Further, in reaching a decision whether to permit
a new chemical to enter the market place, EPA tries to
encourage safer chemicals to succeed in commerce and replace
their riskier counter parts which are already available.
Therefore, a “relative risk” policy has always beer a
component of the New Chemicals Program. The “relative risk”
policy allows EPA to minimize regulatory burdens on new
chemical substances that will substitute for more toxic
chemicals that are already in wide-spread use. This policy
is designed to reward and encourage industrial innovation if
it results in the development of safer new chemicals.
More recently, EPA has been considering taking a variety of
additional actions to better promote pollution prevention
including working directly with individual companies to
encourage them to improve their waste minimization practices.
IX. Trends/New Directions
a. Expedited P0110w-up Rule. The EPA has nearly completed
rulemaking which will establish an expedited process for
issuing section 5 (a) Significant New Use Rules (SNURS).
The new process will enable EPA to more quickly extend by
rule the restrictions imposed upon original P submitters
through section 5(e) consent orders to all subsequent
manufacturers, importers and processors of the subject new
chemical substances. The rule will also enable the Agency
to expedite promulgation of SNURS for those new chemical
substances for which no section 5(e) consent orders have been
issued, but which may present hazards to human health or the
environment if exposures or releases are significantly
different for those described in the P1w.
b. Ussr lees. In October of 1988, EPA began collecting user
fees for P101 reporting. A $2,500 fee became required for
most new chemical submissions which may result in the
collection - f n-’arly $3 million for the U.S. Treasury in FY
1989. These funds would require an appropriation by Congress
to become available to EPA use.
c. Initiatives. OTS senior managers have recently
completed a series of analyses which examined both long and
shorter term methods for further streamlining the New
Chemicals program. These reports were submitted to the
Office Director for review and discussions at that level are
expected to follow. Long term initiatives recommended

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—15—
include regulatory revisions designed to reduce the number
of new chemical submissions and abbreviate time devoted to
preparation of consent orders.
d. Nov and Existing Chemicals Program Integration. OTS is
currently emphasizing ways to more fully integrate the new
and existing chemical programs to eliminate any new chemical
bias.
e. Exposure Based Policy. Recently, EPA implemented a
policy designed to further enhance our ability to get test
data on new chemical substances. Under this program EPA has
begun to require basic toxicity testing for all high-volume
new chemicals if the Agency believes there will likely be
substantial or significant human exposures or substantial
environmental releases of the chemical. The objective of the
policy is to obtain more test data on those new chemicals
that demonstrate the greatest potential for human exposure
or release to the environment. This program on high—volume
chemicals has been in place for over a year now and we are
beginning to see the results of the test data now.

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AL-RBEc0: 5(e) Action Letter - Risk-Based Ecotoxicity
Re: P!’ThJ-8
Dear ___________________
This letter concerns the above-referenced premanufacture
notice (“PMN”) which you submitted pursuant to section 5(a) of
the Toxic Substances Control Act (“TSCA”) and 40 CFR Part 720.
The PMN described the chemical substance as _______________
(insert trade name from item 5 on page 5 of P!0T, or specific name
if trade name unavailable].
The Environmental Protection Agency (“EPA”) has determined,
under section 5(e) of TSCA, that the available information is
insufficient to permit a reasoned evaluation of the environmental
effects of the PMN substance, and that the manufacturing,
processing, distribution in commerce, use, or disposal of the
substance may present an unreasonable risk of injury to the
environment. This letter provides you with the basis of EPA’s
determination of potential unreasonable risk and describes your
options in light of this determination.
This determination is based on Quantitative Structural
Activity Relationship (QSAR) derived from test data on
structurally similar ________. Based on this OSAR, EPA expects
toxicity to aquatic organisms to occur at a concentration of
_______ P ’2I substance in surface waters. EPA expects releases of
this Pt fl4 substance to water to result in surface water
concentrations significantly exceeding that concern level.
Given EPA’s determination under section 5(e), EPA will
regulate this substance pending the development of sufficient
information. Your company has several options available.
The first option is for EPA and your company to enter into
an expedited section 5(e) Consent Order. The Consent Order would
permit limited manufacture, processing, distribution in commerce,
use, and disposal of the substance, pending the development and
review of information addressing the potent ial risks. Signing
the Order would not constitute an admission by your company as to
the facts or conclusions underlying the Agency’s determination in
this proceeding.

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2
Enclosed is a copy of a generic section 5(e) Order. The
generic Order provides an example of the standard language EP
uses in section 5(e) Orders of this type. Please note, however,
that the generic Order was developed for various possible cases
and therefore many of its provisions may not apply to this P J
substance.
For this PMN substance, the Consent Order would require your
company to:
submit to EPA the following toxicity testing sixteen weeks
before manufacturing or importing kilograms of the P
substance:
1. A 96-Hour Bioassay in Alagae (40 CFR 797.1050),
2. A 48-Hour LC 50 test in Daphnia (40 CFR 797.1300), and
3. A 96—Hour LC 50 test in Fish (40 CFR 797.1400);
) comply with the Hazard Communication Program labeling,
Material Data Safety Sheet (MSDS), and worker training
provisions;
) not manufacture the PP substance ____________________________
) not process the PMN substance ________________________________
) not use the PMN substance ____________________________________
distribute the P!* substance only to a person who agrees ’
to follow comparable restrictions or __________ ;
distribute the PMN substance only
dispose of the PMN substance only by
( ) not release the PMN substance into the waters of the United
States ______
and ( ) maintain relevant records.
This PMN is a candidate for an expedited concurrence
procedure which the Agency is employing to reduce development
tune for 5(e) Consent Orders. Under this procedure, an Order
with the previously—described provisions will be drafted in final
form directly from the standard Order language, signed by the
Assistant Administrator for the Office of Pesticides and Toxic
Substances, and sent to you for signature. This would allow you
to commence manufacture immediately after EPA’S receipt of the
Order with your signature, instead of waiting for further
internal Agency review and concurrence. To take advantage of the
expedited concurrence procedure, you must agree to accept the
signed Order without modification .
To begin work developing the Consent Order, EPA will require
from you a written suspension of the PPTh review period for at
least 60 days to permit development of the Order. This is the
minimum period of time required to develop and obtain final

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3
signatures for a section 5(e) Order. Additional suspensions to
provide more time may be required if, during the development
process, your company presents new facts which necessitate
modifications to the Order language. If, however, any suspension
time remains in effect when the Order is signed, EPA will revoke
the remainder of the suspension period to make the Order
effective immediately. Suspensions of the PMN review period are
authorized by 40 CFR 720.75(b).
After your company commences manufacture of the r*
substance and submits a notice of commencement (“NOC”) of
manufacture within 30 days as required by 40 CFR 720.102, EPA
will add the substance to the TSCA Chemical Substances Inventory
maintained pursuant to section 8(b) of TSCA. The substance will.
no longer be a “new chemical substance” as defined by section
3(a) of TSCA. Consequently, any other company may manufacture
the substance without being required to submit a r i or comply
with any other restrictions under section 5 of TSCA, unless EPA
promulgates a “significant new use rule” (“SNUR”) pursuant to
section 5(a)(2) of TSCA. Therefore, if a Consent Order is
developed for this PMN substance, EPA intends to develop a SNUR
concurrently with the Consent Order. The SNUR will contain
essentially the same provisions as the Consent Order and will
extend those provisions to all other companies which manufacture,
import or process the P! .Th1 substance after the effective date of
the rule. According to section 5(a)(1)(B) of TSCA, any company
wishing to deviate from the provisions of a SNTJR must submit a
significant new use notice to EPA at least 90 days before doing
so. Rulemaking procedures to develop a SNUR requires more time
than development of a Consent Order. However, the Agency expects
to promulgate the SNUR for this PMN substance using the expedited
procedures for SNUR development which are expected to be
promulgated at 40 CFR 721.160. This means that EPA could
promulgate a SNUR for this substance within as few as 180 days
from receiving your company’s NOC.
As a second option, you may elect to discuss modifications
to the standard language of the Order. However, any modification
to standard Order language will significantly lengthen the amount
of time required to develop both your Order and the corresponding
SNUR. Any deviation from the standard language will necessitate
more extensive Agency review, making the expedited procedures
impossible. If you wish to pursue this option, you should submit
to EPA a written suspension of at least 90 days. Additional
suspensions may be required depending upon the complexity of the
changes being sought and the amount of time your company spends
reviewing the document.
The third option is, before commencing any manufacture or
import of the PMN substance, to develop and submit information
sufficient to permit a reasoned evaluation of its environmental
effects. To pursue this option, you must agree to suspend the

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4
PMN review period for a time period sufficient to permit
development and review of the test data identified above. Other
information On the potential effects or exposures of the PMN
substance might also negate EPA’S finding of potential
unreasonable risk.
EPA strongly encourages you, before performing any testing,
to consult with the Agency concerning selecting a protocol or
developing the information. Published test guidelines (e.g., 40
CFR 797 and 798) provide general guidance for development of test
protocols, but are not themselves acceptable protocols. Test
data should also be developed according to TSCA Good Laboratory
Practice Standards (GLPS) at 40 CFR Part 792 (48 FR 53922;
November 29, 1983) and through the use of methodologies generally
accepted at the time the study is initiated. Failure to obtain
protocol approval or follow GLPS could result in data
insufficient to permit a reasoned evaluation of the effects of
the substance. Any test data submitted should include protocols,
raw data, and results.
After the testing is completed, it will be reviewed and
analyzed by the Agency. If the testing indicates the potential
for chronic effects, EPA may require you to conduct further
testing. If the test results indicate that the P1*1 substance
poses a risk of acute and/or chronic toxicity to aquatic
organisms, the Agency may regulate to control release to surface
waters.
The fourth option is to withdraw your P1*1. Such a
withdrawal will not prejudice any right to resubmit in the future
a P 1*1 or exemption notice for the sante substance to EPA under
section 5(a) or 5(h) of TSCA. A written notice of withdrawal
must be sent to EPA in accordance with 40 CFR 720.75(e).
Within 30 days of your receipt of this letter, please
complete and return to EPA’S Program Manager the enclosed
“Selection of Regulatory Options” form, which will notify EPA of
your company’s decision as to which option it wishes to pursue.
If you decide to pursue upfront testing or a section 5(e) Consent
Order, you should also include on the enclosed form a written
suspension of the P1*1 review period.
If you do not complete and return, within 30 days, the
enclosed form indicating your decision and providing an adequate
suspension of the review period to pursue one of the above
options, EPA will assume that you do not wish to pursue a
negotiated approach to the resolution of this P1*1 review. Under
this scenario, EPA may unilaterally issue a proposed Order under
section 5(e) of TSCA that may completely prohibit the
manufacture, processing, distribution in commerce, use, or
disposal of the P1*1 substance pending the development of
information sufficient to permit a reasoned evaluation of the

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5
effects of the substance. Consequently, my staff would issue a
notice under section 5(c) of TSCA extending the Pr review period
to 180 days to permit development of the Order under section
.5(e). In addition, you would be contacted by a representative of
the Information Management Division (IMD), Office of Toxic
Substances (OTS), and required to substantiate all Confidential
Business Information (CBI) claims in your P! as a condition of
maintaining the information as CBI.
Under the procedures in section 5(e), EPA would issue the
proposed Order no later than day-135 of the P! review period
and, on or before the day the Order is issued, notify you in
writing of the substance of the determinations underlying the
Order. The Order would become effective upon the expiration of
the review period, unless you file with EPA, within 30 days of
receiving the notification, formal objections to the Order
specifying with particularity the provisions of the Order deemed
objectionable and stating the grounds therefore. EPA would
review the objections and decide whether to apply to a United
States District Court for an injunction to enforce the terms of
the Order. This process is described fully in section 5(e) of
TSCA.
If YOU have any questions or comments, please contact the
Program Manager for this P!Th1, _______________, at (202)

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DL-HH: Drop/Concern Letter - Human Health
Re: P—88—__________
Dear __________________
t4 6:C,/tJ ” 1
This letter responds to- bur Premanufacture Notice (PMN),
- - , received by the Environmental Protection
Agency (EPA) on __________• 1988.
The notice review period for this P?’ J expired on _________
1988. Therefore, you are now free to manufacture or import this
substance. However, EPA is concerned that exposure of
unprotected workers to the PMN substance during manufacturing,
processing, or use may present an unreasonable risk of injury to
health. Specifically, EPA is concerned, based on test data on
other ___________• that the P!4I substance may cause ______________
toxicity.
At this time, EPA does not expect significant release to
the environment of, or exposure of people to, the PP substance.
Consequently, EPA has not determined that the manufacturing,
processing, and use of the substance may present such an
unreasonable risk to health or thj.en ronInent to warrant
regulation by EPA. However, EPA% T7-reeei emde that, to
mitigate inhalation exposure to workers, any workers who may be
exposed,,to the substance during manufacturing, processing, and
use wear a N gSH-approved respirator and, to mitigate
dermal exposure, d1 t d wear adequate protective clothing which
covers any exposed parts of the body, impervious gloves, and
chemical safety goggles or equivalent eye protection.

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Please note that 40 CFR 720.102 requires you, within the
first 30 days Of commencement of manufacture or import of..t. .eq
P T substance, to send a notification letter to the Document
Control Officer (TS—790), Office of Toxic Substances, U.S.
Envirorunental Protection Agency, Room E-201, 401 M Street, SW.,
Washington, D.C. 20460. This notification letter must contain
the following information for the PMN substance: specific
chemical identity, prexnanufacture notice number, and the date
when the manufacture or import commences. This information will
be used to add the new substance to the
- Chemical Substance, 2Z,,i r ’17.
If you wish the chein al identity to be listed on the
Confidential Inventory, ’tkO’ c1aim of confidentiality must be
reasserted and substantiated in accordance with 40 CFR
720.85(b). If there are any problems with the generic name to
be used. EPA’s Information Management Division will contact you
to negotiate a generic name that is acceptable to you and EPA.
If you have any questions or comments, please contact
Robert Wright, the Program Manager assigned to this PMN, at
(202) 382—7800.
Sincerely,
Section Chief
Premanufacture Notice
Management Branch

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DL-Eco: Drop/Concern Letter - Eco/Hea lth
Re: P-88-_________
Dear _________________-
This letter responds to your Premanufacture Notice (P!i.ThJ)
P-88— , received by the Environmental Protection Agency
(EPA) on _______________ , 1988.
The notice review period for this P! expired on ________
1988. Therefore, you are now free to manufacture or import this
substance. However, EPA is concerned that exposure of
unprotected workers to the PMN substance during manufacturing,
processing, or use may present an unreasonable risk of injury to
health and to the environment. Specifically, EPA is concerned,
based on test data submitted with the P!*T, that the substance
may cause __________ toxicity. Based on test data on other ____
_________________________• EPA is concerned that the substance
may be toxic to aquatic organisms.
At this time, EPA does not expect significant re1ea e to
the environment of, or exposure of people to., the P!flJ substance.
Consequently, EPA has not determined that the manufacturing,
processing, and use of the substance may present such an
unreasonable risk of health to th ç nv4 ronment to warrant
regulation by EPA. However, EPA ‘iTh igIy reeominen& that, to
mitigate inhalation exposure to workers, any workers who may be
expose ,)o the substance during manufacturing, processing, and
use £ u4d - wear a NZ9flH-approved respirator and, to mitigate
dermal exposure, s 6U4-4 wear adequate protective clothing which
covers any exposed parts of the body, impervious gloves, and
chemical safety goggles or equivalent eye protection. EPA .also
&.-i.z Z stren ly recommends that your Company’ take all measures
necessary to prevent release of the PfQ substance into the
environment.

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Please note that 40 CFR 720.102 requireS you, within the
first 30 days Of commencement of manufacture or import of-me ‘4
PMN substance, to send a notification letter to the Document
Control Officer (TS—790, Office of Toxic Substances, U.S.
Environmental Protection Agency, Room E —201, 401 M Street, SW.,
Washington, D.C. 20460. This notification letter must contain
the following information for the P!’2J substance: specific
chemical identity, premanufacture notice number, and the date
when the manufacture or import commences. This information will
be. used to add the new substance to the iaery—of—E dst4f -----—-
Chemical Substance ç
If you wish the chemical ‘identity to be listed on the
Confidential Inventor claim of confidentiality must be
reasserted and substantiated in accordance with 40 CFR
720.85(b). If there are any problems with the generic name to
be used, EPA’s Information Management Division will contact you
to negotiate a generic name that is acceptable to you and EPA.
If you have any questions or comments, please contact
Robert Wright, the Program Manager assigned to this PMN, at
(202) 382—7800.
Sincerely,
Section Chief
Preinanufacture Notice
Management Branch

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May 9, 1989
INDEX OF PNMB BOILERPL TES
Sustension Letters File Name
Premanufacture Notice SL-P
Test Market Exemption SL-TME
Low Volume Exemption SL-LVE
Polymer Exemption SL-PE
Rescind Suspension SL—RCND
DroD/Concern Letters
Human Health DL-MH
Eco/Mea lth DL-ECO
Briefina Paoers
Risk—Based HP-RB
Exposure—Based BP-XB
Hybrid Risk/Exposure BP-HY
Bring-Back BP-BB
5(e Action Letters
Risk—Based Human Health Triggered Testing (Old) ALRBHHP1’.OLD
Risk—Based Human Health Triggered Testing (New) ALRBHHTTINEW
Risk-Based Human Health Pending Testing (Old) ALRBHHPT.OLD
Rish-Based Human Health Pending Testing (New) ALRBHHPT.NEW
Risk—Based Ecotoxicity (Old) AL-RBECO.OLD
Risk-Based Exotoxicity (New) AL-RBECO.NEW
Risk-Based Hybrid AL-RBHY
El Gordo AL-EG
Exposure-Based Human Health (Old) AL-XBHH.OLD
Exposure-Based Human Health (New) AL-XBHH.NEW
Exposure-Based Ecotoxicity (Old) AL -XBECO.OLD
Exposure-Based Ecotoxicity (New) AL-XBECO.NEW
Exposure-Based Hybrid (Old) ALXBHY.OLD
Exposure-Based Hybrid (New) ALXBHY.NEW
Risk-Based Upfront Ecotox Testing (Old) ALRBUFEC.OLD
Risk-Based Upfront Exotox Testing (New) ALRBUFEC.NEW
Exposure—Based Upfront Ecotox Testing (Old) AL-XBUFEC..OLD
Exposure-Based Upfront Ecotox Testing (Old) AL-XBUFEC.NEW
References for Health or Eco Risks AL-REF

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2
5(e Consent Orders
Risk-Based Human Health (Old) CO-RBHH.OLD
Risk-Based Human Health (New) CO-RBHH.NEW
Risk—Based Ecotoxicity (Old) CO-RBECO.OLD
Risk-Based Ecotoxicity (New) CO-RBECO.NEW
Exposure—Based Human Health (Old) CO-XBHH.OLD
Exposure-Based Human Health (New) CO-XBHH.NEW
Exposure-Based Ecotoxicity (Old) CO-XBECO.OLD
Exposure-Based Ecotoxicity (New) CO-XBECO.NEW
Exposure-Based Hybrid CO-XBHY
Worksheet COWRICSHT
5(e Consent Order Transmitta].s
Order Workgroup Memo WRKGRP
Transmittal Memo OTS to OPTS OPTS
Transmittal Memo OPTS to OGC + OPPE OGC
Transmit Draft Order to Company for Comment DRAFT
Transmit Order to Company for Signature COMPSIGN
Transmit El Gordo Order to Company for Signature ELGDSIGN
Transmit EPA—signed Order -.
to Company for Signature EPASIGN
Transmit All Signed Order to Company for Records ALLSIGN
5(c Extensions
5(c) Extension Federal Register Notice 5CFR
Withdraw 5(c) Federal Register Notice 5CWD
Incomolete & Ineliaible Letters
Incomplete Letter — PlU( INCPI 2
Incomplete Letter — PE INCPE
Incomplete Letter — LVE INCLVE
Ineligible Latter — LyE INEILVE
Ineligible Letter — PE INELPE
THE FR Notices
Grant TMEGRANT
Grant With Restrictions TMEGWR
Denial TMEDENY
Modification TMEMOD
Grant with Comment Period TMECOM

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3
P)O Not Reauired Letters
P1*1 on Inventory PMNONINV
Polymer on Inventory PLYONINV
Mixture on Inventory MIXONINV
Non-Isolated Intermediate NNISIINT
Free Radical Initator FRERADIN
Surface Modified Not Subject to PMN SURFMOD
Cosmetic Use COSMTCUS
Ti s and ComDlaints
Referral of Potential Enforcement Action TIPCOVER
Referral of Potential Enforcement Action TIPFORM
Miscellaneous
Protocol Review Letter PRTCLREV
LVE Grant/Concern Letter LVEGRANT
Rule Workgroup Memo RULEWG

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UNITED STA ES ENVIRONMENTAL PROTECTION AGENCY
w sHINGroN.Dc 20460
— r,rrICCQ
DESTICIDE AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Mock PMN
FROM: Michael Hackett 1/
Case Officer
Compliance Division
Office of Compliance Monitoring (EN-342)
TO: Juanita Geer
Document Control Officer
Office of Toxic Substances (TS—793)
I am sending you under separate CBI cover (DCN 208380253)a
Mock PMN which is to be designated with an “I” and processed as
a PMN submission.
(x) An Inventory search for this substance is required.
) An Inventory search for this substance has been conducted.
Please provide me with the name of the project manager for
this Mock PMN. If you have any questions regarding this matter,
feel free to contact me at 475-9309.
Attachment
cc: Ken Moss (TS-794)
Pnntod on Recydod Pa_ne’

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K

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UNiTED STATES ENVIRONMENTAL PROTECTION AGENCY
WASKINGTON D.C. 20460
‘2
SUBJECT: IMD Validation of Notice df Commencement Date
‘I
(TS—793)
)
I 1989
PC$TICIOL ANO TONIC SUUST* c15
MEMORANDUM
FROM: Linda A. Travers, Director
Information Management Division
TO: Charles L. Elkins, Director
Office of Toxic Substances (TS-792)
Pursuant to your memorandum of January 23, attached are IMD
procedures for validating notices of commencement by the reported
commencement date.
Attachment
cc: 5 .EWConroy, II
F. Stiehi
\

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VERIFICATION OF VALID COMMENCEMENT DATE.
A. The DCO will examine the reported commencement date to
determine whether it meets the following requirements
under the P I rule:
1. A specific month, day and year must be cited.
2. The commencement date must be subsequent to the
termination of the PMN or exemption review period. (The
DCO staff will verify the review period for the
PMN/exemption.)
3. The NOC must be received by EPA between one and 30
days after the commencement date.
4. The commencement date reported must be prior to the
date the NOC is received by EPA. That is, assertions
such as manufacture “is beginning,” “will begin,” or
“will have begun” are not sufficient.
B. Failure to meet any of requirements (1) through (3) are
considered non-fatal to the NOC: any otherwise valid notice
which does not meet one of these requirements will nonetheless
be processed (i.e., CIS shall add the substance to the
Inventory). However, one or more of the following actions
shall be taken:
1. If requirement (1) is not met, DCO shall notify the
submitter by letter or telephone that a specific date of
manufacture or import must be provided to EPA within 30
days of manufacture. If no response is received within
30 days of notifying the submitter or if the submitter
responds with a date more than 30 days prior to the date
EPA originally received the NOC, the case shall be
referred to 0CM.
2. If either requirement (2) or (3) is not met, the case
shall be referred to 0CM.
C. Failure to meet requirement (4) is considered fatal to the
NOC: the substance shall not be added to the Inventory. DCO
shall send a letter to the submitter notifying him or her that
the document received does not constitute a valid NOC, and
that an NOC must be received by EPA between one and thirty
days after manufacture. If no valid NOC is received within
30 days of sending the letter to the submitter, the case shall
be referred to 0CM.

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Notice of Commencement
Chronology and Citations to the Reporting Requirement
1. Section 8(b)(l) of TSCA provides that “(i]n the case of a
chemical 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.”
Further, [ t]he Administrator shall not include in such list
any chemical substance which is manufactured or processed
only in small quantities ... solely for the purposes of”
research and development.
2. January 10, 1979: EPA publishes proposed PMN/NOC rule.
Proposed section 720.52(b) (44 FR 2278; exhibit 1) provides
the NOC must be submitted “no later than the day the person
first manufactures or imports the substance for a non—
exempt commercial purpose.”
3. May 15, 1979, EPA publishes interim policy which includes
an HOC reporting requirement. This document refers to the
§8(b)(1) language as mandating a statutory reporting
requirement (44 FR 28567; exhibit 2). Hence the 5/15/79
requirement is applicable and in force until the revised
determination (40 CFR Part 720.120) was made explicitly
effective. The 5/15/79 requirement speaks only to
subsequent manufacture or import following submission of a
PMN. “Any person who submits a (nbc] under this interim
policy, and who begins to manufacture or import the new
substance for commercial purposes, must submit a notice of
this fact to EPA on or about the date when manufacture or
import commences so that the Agency can add the substance
to the Inventory.”
4. May 13, 1983: EPA publishes final PMN/NOC rule. Section
720.102(b)(l) (48 FR 21753; exhibit 3) provides that if
manufacture begins on or after the effective date of this
rule, then the HOC must be submitted “on the first day of
such manufacture.”
5. September 13, 1983: EPA publishes revised HOC rule with
effective date of October 26. 1983 . Section 720.l02(b)(1)
(48 FR 41140; exhibit 4) provides that if manufacture
begins on or after the effective date of this rule, then
the NOC must be submitted “on or no later then 30 calendar
days after the first day of such manufacture....”

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—2—
6. April 22, 1986: EPA publishes non-substantive amendment to
the HOC rule to make clear the timing for submission of the
HOC. Section 720.102(a) (51 FR 15096; exhibit 5) provides
that manufacturers or importers commencing (after PMN
review is complete) non-exempt commercial activities of a
new chemical substance must submit an NOC on or no later
than 30 days after the non-exempt manufacture or import
occurs. Quantities of the new substance which have been
produced or imported for R&D and will be distributed for
non-exempt purposes is not a permissible basis for
submission of an NOC.
7. September 14, 1989: Judge Frazier reviews the NOC
reporting requirement as it relates to R&D production and
distribution prior to the April 22, 1986 federal register
notice. See, In the Matter of B. F. Goodrich Company ,
Docket No. TSCA-89-H-07.

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WEDNESDAY, JANUARY 10, 1979
PART II
E NVI RO NMENW:
• PROTECTIOP*
TOXIC SUBSTANCES
CONTROL
Premanufadvre
ments andRethw
Proced ,à
.
EXHIBIT I

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PROPOSED RULES
2278
ure under the Act, including impact on
the national economy, small business.
technological Innovation, the environ-
menL and public health.
(e) Procedures for reporting. EPA
will notify in writing any person sub-
ject to a reporting requirement under
this section. The. notification will be
sent by certified mail, with return re-
ceipt requested. The written notifica-
tion will include: —
(1) A copy of this § 720.50:
(2) A detailed description of the In-
formation which is required to be sub-
mitted;
(3) The name, address. and tele-
phone number of the person to whom
the information must be submitted;
and,
(4) The date by which the informs-
tion must be submItted, which shall be
no sooner than 15 days after the
person receives the notification.
§ 720.51 Requirements for submittal of
health and safety studies under § 8(d)
of the Act.
(a) Appiicabtlity. EPA may use the
procedures estabilahed in paragraph
(b/ of this section to require any
person who has possession of a health
and safety study to submit the study,
If the Agency believes that the study
would assist in the evaluation of the
health or environmental effects of the
manufacture, processing, distribution
In commerm, use, or d j.en ] of a new
chemical substance for which the
Agency received a px anufacture
notice.
(b) Prooedwes. EPA wlfl notify In
writing any person subject to a re-
quirement under this section. The no-
tification will be sent by certified mall,
with return receipt r uested. The
written nod&atton will “de :
(1)AcyofthIs 72Iil
(2) A description of the requested
study;
(3) The name, addee, and tele-
phone number of the person to whom
the study must be submitted; and,
(4) The date by which the study
must be submitted, which date shall -
be no sooner than 11 days after-thE
person receives the notifirelton .
* 720.52 Nodes .1 ft ’ c i ma.-
ufacter. or bapest
(a) AppttcabWf p. Any person who
commences to manufacture or import
for a non-exempt commercial purpose
a new chemical substance for which
the person previously submitted a pie.
manufacture notice under this Part
shall submit the notice proscribed by
this section.
(b) When to repo,t The person must
subetit the notice to EPA no later
than the day the person first manu-
factures or lmporta the substance for a
non-exempt commercial purpose.
(C) Inforinatzon to be reported, (1)
To report a chemical substance, a
person shall complete, sign, and
submit to EPA a “Notice of Com-
mencement of Manufacture or
Import.” ThiS form has 0MB No.
The notice must include a refer-
ence to the relevant premanufacture
notice as required by the form instruc-
tions. In addition, if the person has as-
serted a confidentiality claim under
*720.41(b) he must certify that any
substantiation previously submitted to
the Agency Is materially accurate as of
the date of commencement of manu-
facture or Import indicated by the
notice.
40 CFR Part 720
Pameaxuracrum No’rwzc&nox rca New
CH CAL Suuanncm
APPenSIX I
Sections 5(dX IXB) and (C) of TSCA re-
quire persons to submit in their premanu-
facture notices all test data in their pease..
slon or control, plus descriptions of any
other data which are known to or remen-
ably ascertainable by them. Section 720.33
of the Piemanufacture Notification Rules
implement these provisions of the Act. to
particular, I 720.33(cXl) provides that per.
sons need not submit data that .ppcar ix
periodicals which are listed In this Appendix
1. provided they submit st.,i vd Uteatu_re
citatioss for the data.
The pertodi sls listed are those to which
EPA’s Office of Toxic ubV”• . ( )
Immediate sosem on a retula, on-call basis.
From time to time EPA Ul emw this liii,
primarily to add new lictth us OlSa
access to p&”dicais Improves.
Areamix 1—Pensoaxcas. Tm sen
1. Accounts of Ch. . ,fri Research, 1815-.
present
2. AIr Pollution Control A4.tI.t Jour.
nal, 1974-present
3. AmerIcan C”— ” ’ Soolety Journal.
1958-present _
4. American Indestrial Hyglence Msoclstiqn
Journal July 19 19-gemsut
5. AmerIcan 1953-present
I. Anslytical Chemistry Journal, 1957-pies-
eat
7. Annual Review of Ecology and Siutomat.
ice. 1970 VoL l-enI
8. ArchIve. of Environmental C’ ”-
don and TO ’ IY . 1972-pramnl
9. Archiv fur Toxicology, 1908-present
10. Archive of l vtronmentaL Resith, 1960-
present
11. AP-.c.pherte Environment, an Industrial
Journal, 1967-9- ... ..t
13. Bioc’-Pbarmaco logy. i95$- ue.-
ent -
12. BrItish Journal of Indu.Utel “ ‘ ‘
1973-present _
14. Bulletin of Environmestal
don and Toxicology, l- ...I
15. Cancer Research. 1953-piosent
II. Chomospbeie W72-pnment
17. CRC Critimi Reviews ix Tox lsolcs*,
18. Ecolcsy,IPTO-prment-
19. Environment Health Peras Uv - 117$-
present
20. Environment a -t .s , and Te”etp ,
19 17— 5.uL.4
21. Food and Cosmetics Toxicology. 1963-
present
22. Health Physics, 1958-present
23. I.A.R.C. Monographs, all volumes
24. InorganIc Chemistry. 1962-present
25. Journal of Agricultural and Food Ch
istry. 1953-present
26. Journal of the Fisheries Research Board
of Canada. 1972-present
27. Journal of Organic ChemIstry, 1982-
present
28. Journal of Pharmacology and Experi-
mental Therapeuties. 1969-present
29. Journal of Physical ChemIstry, 1963-
present
30. Journal of Physical Chemical Reference
Data, 1978-present
31. Mutation Research. 1914-present
32. National Academy of Sciences Proceed-
logs, July 1978-present
33. NatIonal Cancer Institute Journal, 1978-
present
34. Nature. 1960-present
35. New England Journal of MedicIne, 1969-
present
30. PesticIdes Monitoring Journal, 1967-
present
37. Residue Review. l9 0 (VoL 3)-present,
38. ScIence. 1950-present
39. Teratology. 1978-present
40. To’$ sy and Applied Pharmacology.
DeceseSer 1814-present
41. Water Pollution C oI Federation
Journal, 19 10-presset
42. Weed 8”— ”e . iNa-gemant
48. Zeneblotlcu, 1978-present
Momma Ov’ ’- von
Peo. em O c lta id
w. cmexc*i lidasramp ft.
Pumeaavp*crun Novsercuioa ‘,.
I. M ROUID LID ena ,css
u. seals amo&ca -.
In aaas i svisTaiic
IT. 55 $ CAI. 5VIflLI
V. JT5T TfliO TID 051 OP LSDRTZOPAL
This as .lrvffiefl$ contains gu*” for ore-’
sting psupo..4 ewusic n. for chemical
su t .s’ whom identities are “—d eon-
fidential for purposes of EPA’s Presnadulso.’
ture NoU r l’Prcoram The.. guidelInes
an amended veeslcn of r’ ”ws Which
EPA first made’ available In AprIl, 1817, to
saint who claimed edf I c chemimi
Identity confidential for pwp. of tb
Ch.seIseI Sebatome Inventory. The Agency
has caedifled them to conform to the pro-.
manufacture notIfication rules. These pro-
posed rules would require persons who claim
confidentIality 11th rmpect to apesihfe
identity t foU .lo these 5 n4.i.iiv., .
In ersating a - , g-—’4 generic name. EPA
solicits ec” ’ta concerning the app11ca . .
ity of these g” ’ ix Implementing the
confidendel “ W y requirements of the
premanufacture notification rule..
z, -‘ sen
Proposed *720:41’ would require any’
person who cI do. Identity of his new
as nm e idssticl to provide a
datuUe4, written suppcut
the da . to —‘ ‘‘.$be mice wouldre-
qufreamh p ani to sebmit a pi’ asd’g
neris forth, which “Is only
as gs siic r to protect the eonfl
dendol ‘ —“Iy of the chemiasi cob.t.noa.
M USI$1 VOl. 44, NO 7—W AY, MI IY 14, 1979

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Tuesday
May 15, 1979
PartV
Environmental
Protection Agency
Toxic Substances Controi initial and
Revised inventorles Premanufacturing
Notification Requirements and Review
Procedures
EXHIBIT 2

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Federal Register I Vol. 44. No 95 ITuesday May iS. 1979 / Notices
28567
(3) PrtnC:pOI Place of BusinesS
Street —
city—
State
(4) Techmco! Contact
%ame and Title —
cr..i
Stats -
Telephone Number
(5) Parent Company (My company that owns
or controls 50% or more of lie submitter’s
voting stock).
Name
Street
City
State
Notice in the “Federal Register 0
Section 5(d)(2) requires EPA to
publish In the Federal Register a notice
of receipt of each preinanufacture notice
within five days of receipt of the
premanufacture notice. Subject to I 14.
this notice must include an IdentifIcatIon
,f the new substance. a list of uses or
intended uses. and a description of
:ertetn test data. As a matter of policy.
EPA will publish the notice In the
manner described in 720.32 of the
proposed regulations. In addition, the
agency will publish the name of the
rubmitting company. unless this
information Is claimed confidentiaL
Persons should review the Interim
confidentiality procedures. below, with
regard to EPA’s policy on publication of
information which a person considers to
b confidential.
Notice of Commencement of
Manufacture or Import
Any person who submits a notice
wider this Interim policy, and who
begin. to manufacture or import the new
substance for commercial purposes.
must submit a notice of this fact to EPA
on or about the dale when manufacture
or Import commences so that the Agency
can add the substance to the Inventory.
At a minimum this notice must Include
the identity of the ,ubstance the
premanuuecture document
which the Agency previously assigned
to the substance in he I 5(dflz) V.dsesl
Register notice; and the date upon which
manulacture or import commences.
There is no’reqwrement that the notice
be submitted in any particular form. ft
should be addressed to the Document
Control Officer. Office of Toxic
Substances. at the address indicated
above. . -
This reporting requirement is imposed
under I 8(b) of TSCA. That provision
states “In the case of a chemical
substance for which a notice is
submitted wider Section 5. such
chemical substance shall be induded in
such list (the Inventory) as of the
earliest date (as determined by the
Administrator) on which stich
substances was manufactured or
processed in the Untied States.” EPA
believes that a submittal of a notice of
commencement is a reasonable method
to implement this statutory provision.
Cotifidentiality
Pending the promulgation of 5
regulations, the assertion and review of
confidentiality claims, and the
substantive determination of whether
information should be disclosed, will be
governed by EPA’s general rules for
confidentiality of business information
submitted under TSCA. 40 CFR 2.301
Section 2.308 incorporales by reference
the bulk of the general provisions of 40
CFR Part 2. the Agency. rules for the
handling of confidential business
information. EPA amended 40 CFR Part
2 on September 8. 1978 (43 FR 39997) and
on March 23. 1979 (44 FR 17073). The
remainder of this section addresses
what EPA believes those provisions
require. and how the Agency will
implement them. Except as stated to the
contrary. EPA will follow the
confidentiality procedures of 40 CFR
Part 2. The Agency will resolve
individual issues not covered by this
discussion on a case .by ’case basis. In
accordance with 40 CFR I 2.308 and
relevant pro isions of TSCA.
Until the 5 rules are final and
effective, the policy discussed below
will apply to all information submitted
to EPA wider the premanufacture
notification program. After the rules i ii,
effective, all such information in the
possession of the Agency will be subject
to those rules. To the extent that EPA
imposes new or different requirements
in the rules. EPA will give submitters
ample opportunity to update or modify
confidentiality claims prior to becoming
subject to any new requirements.
Cenerol Procedures for Assertirs
Confidentiality
A person may assert a business
confidestiuldy claim for any Information
required to be submitted to EPA under
TSCA. including any information
submitted in the premanufacture notice
or the notice of commencement of
manufacture or import.
In accordance with 40 CFR § 2.203, if a
person wishes to assert a business
confidentiality claim (or all or part of
the information submitted to EPA, he
must assert this claim when he submits
the information. He must assert this
claim in the manner described in
2.203(b) (See below.) The Agency will
disclose information covered by such a
claim only to the extent, and following
the proceduri’c ji t forth in 40 CFR Part
2. Subpart B. If the person does not
assert a claim of confidentiality at ‘he
time he submits the information. EPA
will make the information available to
the public without further npttce to the
submitter.
Section 1.203(b) of EPA’s business
confidentiality regulations prescribes
the methods for asserting confidentiality
claims. Among other things. confidential
portions of otherwise non.confidential
documents should be clearly identified.
EPA strongiy urges the submitter to be
as specific as possible in identifying
confidential information. Each page of a
document should be marked
appropriately. In some cases. if non•
confidentIal and confidential material
are mixed on a single page. item.by.item
markings would be appropriate.
Section 2.203(b) also states that where
a portion of an otherwise non•
tonfidentlal document is asserted to be
confidentiaL the person may submit
separate confidential and non-
confidential documents to facilitate
identification and handling by EPA. The
Agency strongly encourages persons to
submit two copies of preinanufacture
notices If some o the information is
claimed confidential Failure to submit
two copies will not affect EPA’s
determination of whether confidential
treatment is appropriate. Section 5(d)(lli
-of TSCA requires the Agency to make
non-confidential information in
premanufacture notices available to the
public. Therefore if a submitter does not
file a non.confldential copy. EPA will
prepare an excised copy for inclusion in
the public file, based upon the
submitter’s confidentiality claims.
Submitter preparation of the public copy
will ease the administrative burden on
EPA. and will reduce the remote
possibility that EPA will inadvertently
disclose information which a submitter
claims as confidentiaL
Substantiation of Claims for Certain
Types of Information
U a person asserts a confidentiality
claim with respect to the specific
chemical identity if a new substance. or
for health arid safety data submitted
with the notice, EPA will review the
confidentiality claim and may
immediately make an initial
determination of whether the
information is entitled to confidenhal
treatment. EPA will take this action
under I 2.204 even prior to the receipt of
a request for release of the information.
because the Agency has determined that
EPA probably will be requested to
disclose the information under the
Freedom of Information Act (FOIA).
Initiation of the procedures of I 2.204

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Filday
May 13, 1983
Part Ii
Environmental.
Protection Agency
Premanufacture Notlficatlon
Preminufacture NOtice Requirementa and
Review Proc.duree Final Rule and
Notics Form
EXHIBtT 3

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I’
p 5 j. j Register I Vol. 4& No. 94 I Fri day. May 13. 1983 I Rules and Regulations
2173
(iii) If the generic name proposed by
E PA is acceptable to the submitter. EPA
will place that generic name on the
public Inventory.
(i v) U the generic name proposed by
EPA is not acceptable-to the submitter.
the submitter must explain in detail why
disclosure of that generic name would
reveal confidential buainee. information
and propose another generic name
which a only as generto u necessary to
protect the confidential Identity. If EPA
does not receive a iveponse from the
submitter withIn 30 days after the
submitter receives the proposed
EPA will place EPA ’. chosen generic
name on the public Inventory. If the
submitter does provide the information
requested. EPA will review the
response. If the submitter’s proposed
generic name Is 2cceptable. EPA will
publish that generic name on the public
Inventory. If the submitter’s proposed
generic name Is not acceptable. EPA will
notify the submitter of EPA. choice of a
generic name. Thirty days after this
notification. EPA will place the chosen
generic name on the public Inventory.
720. C sgsrisserpr:::
I. -
(a) A person who submits information
a EPA undirthis Part on the categories
or proposed categories of mu of a new
ithemIcal substance may assert a claim
of confidentiality for this information.
(hi A submitter that asserts such a
claim must
(1) Report the categories or proposed
categorie. of use of the rn..l
s ub s ii .
(2) Provide. in nonconfidentlal form. a
desatptlon of the uses that is only as
generic u ne’e,siry to pretest the
confl”.”tIaI bn.ni.n Information. The
generic use deseription will be liIath .ded
in the F.dmuI Rs ss notice desatbed
in I 7 L7O.
(c) The mi must inhiltif the
information required by pstigraph (b) of
this section In the specified In
the notice form.
f 720.50 es fries tI..Jth aid . ...M
. I .Th
(a) Lrzjb,madon other than so
chemical identity. Except as provided in
paragraph (b) of this section. EPA will
deny any claim of coi fial.ntialIty with
respect to Information in hi d In..
health and safety study. ‘ zl.,s the
Information would diidoee confidential
business Information concernimp
(1) Processes used In the manufacture
‘r processing of a ch,”csl substance or
ixture.
(2) In the case of a mixture, the
portion of the mixture comprised by any
of the chemical substances in the
mixture.
(3) lnformaton which is not in any
way reLated to ne effects of a substance
on human health or the environment.
such as the name of the submitting
company, cost or other financial data.
product development or marketing
plane. and advertising plan e. for which
the person submits a claim of
confidentiality in accorr 4 n’. with
I 720.80.
(b) Specific chemical identity. (1)
Claims applicable to period pilot to
commencement of manufacnue. A claim
of confidentiality for the period prior to
co—’ ’ant of.manufacture or
import for the ch.InicaI Identity of a
ch aI substance for which a health
and safety study was submitted must be
asserted In conjunction with a claim .
asserted under I 720.85(a).
(2) Claims applicable to period after
commencement of manufacture or
impoa?jbr commercial pwposes. To
“ “u1n the confidential status of the
th,ffijl!2 1 identity of a ith.m4n.J
substance for which a health and safety
study was submitted after
of manufacture or
import . the claim must be reauurted and
substantiated in conjunction with a
claim under 5720.85(b). In addition to
the questions set forth in
I 720.85(b)(S )(lv) of this Pert, the
submitter must answer the following
quesdonai
(I) Would disclosure of the ‘ 4 .””caL
Identity disclose processes used In the
manufacture or processing of a eh. nacel
substance or mixture? Desonbe how this
would ocme. In responding to the
question In I 7m85(bKs)Uv)(A), explain
what harmful competitive effects would
oc from disclosure of this piu sss
Information. -
(II) Would disclosure of the thL ni
Identity fHaI!bou , the portion of a mixture
comprised by any of the substances In
the i b’t ,v ? Desatbe how this would
x. In respondIng to the quesdon In
I 720.85(b)(3)(lv)(A). explain what
harmful competitive effects would occur
from disclosur, of this information.
(U I) Do you assert that disclosur, of
the &eh. ,l Identity is not necessary to
interpret any of the health and safety
studies you have submitted? If so.
explain how a less specific Identity
would be sn -t to interpret he
studies.
(c) Denial of confidentiality claim.
EPA will deny a claim of c Rd.n 4e1fty
for th,mlcal identity under paragraph
(b) of this section. nil . . . .
(1) The Information would dlsclosó
processes used in the manufamurs or
proresfiffig of a heiui4 aj substance or
(2) In the case of a mixture, the
information would disclose the portion
of the mixture comprised by any of the
substances in the mixture.
(3) The specific chemical identity is
not necessary to interpret a health and
safety study.
(d) (Ise of generic names. When EPA
discloses a health and safety study
containing a specific chemical identity.
which the submitter has claimed
con ’4m’dal. and If the Agency has not
denied the claim under paragraph (C) of
this section. EPA will Identify the
rka,n4i ’nI substance by the generic name
selected under I 720.85, (0MB Control
Ne. 207G.4J012)
5720.55 Io Me.
All Information submitted with a
notice. indiidhig any health and safety
study and other supporting
documentation, will become part of the
public file for that notice, unless such
materials are claimed c ”nfldaitiaL In
addition, EPA may add material, to th.
public file. subIecttoSubpsrtEofth:
Pert. Any of the nuncn fi.I.iitial
material desatbed above will be
aveilahli for public inspection In the
Office of Tonic Subs’ ’ e Public
Reading Room. Rm. E-1 . 401 M St..
SW.. Washington. DC 20480, durIng
normal business hours.
of
• imioa _ . of ea.......a.....,t of
omaifactore or lupat
( a) Applicability . Any person who
to manufacture or Import a
new ‘ 4 ’ ’cal substance for a
commercial purpose for which that
person previously submitted a section 5
notice under this Pert must submit.
notice dG -’ mqnt of manufacture
or Import.
(b) When So report (1)Umanufactur,
or — for commeiclal purposes
begluron or after the effective date of
this rule, the mibmittar must submit the
ce to EPA on the fir s t day of such
msnufactwe or Import.
(2)11 manufacture or Import for
commercial purposes begin or will
begin before the 1TuCttvv date of this
rule. the submitter must submit the
notice by the effacllv , date of this rule.
(ci Information to be repaired The
notice must contain the following
Informatiom specific th !il. l Identity,
premanufacture notice “ umber , and the
dare when manufactur, or Import
commences. If the person deimed
riiniuii..l . eiifity confidential In the
‘ -‘ —it notice, and wants the
Ld.nt4ty to be listed on the confldental

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Federal Register / “°• 48. No. 178 I TtieSddy . September 13, 1983 I Rules and Regulations
41132
CNVJRONUENTAL PROTECTION
1ENCY
CFR Pert 720
r 0 p1’S—50002J; TSt4.FRL 241241
premanufacture Notuficat$on Revision
of Regulation and Partial Stay of
Effectlv Oats
AOCNCY’ Environmental ProtectLon
Agency (EPA).
acilosr Final rule: reVisiOn of regulation
and partial stay of effective date .
SUMNARr EPA is staying the effective
date of fl 720.3(y). 720.36. 720.50(c). and
720.78(b) and issuing nonsubstantive
amendments to 720.102 of the final
preinanufacture notice (PMN) rule
issued under section 5 of the Toxic
Substances Control Act (TSCA). Under
section 5 of TSCA. any person who
intends to manufacture or import a new
chemical substance for commercial
purposes must notify EPA at least 90
days before manufacture or import
begins. EPA Is also clarifying other
sections of the rule.
o*i’m The effective date of the
premanufacture notification rule, with
the exception of the stayed sections.
*1720.3(y), 720.31720.50(c), and
78 (b), iaOctoberz6, 1983.
MThIR 5 5NAUONCO AC1
P. McCarthy. Director. TSCA
-rrssiatance Office (TS499J, Office of
Toxic Substances. Environmental
Protection Agency, Ret. E-543, 401 M St
SW.. Washington. DC. 2048t toIl-fies
(800-424-goes), in Washington. D.C.:
(554-1404). outside the USA: (Operator
202—554—1406),
SUPPILMIMTARYflWORN*tlOIC
I. Background
Under section 5 of TECA. any person
who Intends to manufacture or import a
new chemical substance for commercial
purposes must notify EPA at least 90
days before manufacture or import
begins. This requirement has been In
effect sInce July 1, 1979. SInce then, EPA
has received end reviewed more than
2.500 notices on new substances. EPA
has operated the new chemical review
program under Interim policies
published In the Federal Register of May
15.1979(44 FR 28584). November 7. 1980
[ 45 FR 74378]. and July 2. 1982 (47 FR
28980).
EPA proposed a rule to interpret
sectionS requirements and to establish
notification procedures in the Federal
Register of January 10.1979(44 FR 2242).
‘ ns of this rule were reproposed on
‘r 18. 1979 (44 FR 59764). In
.n. EPA proposed processor
repc ting requirements in the Federal
Register of Augi si 15. 1980 [ 45 FR 54842 1
and a clarification of rnporter
equiremcnts on September 23. 1980 (45
FR 63806).
After reviewing public comments and
evaluating its experience in conducting
the PMN program. EPA issued a final
premanufacture notice rule in the
Federal Register of May 13.1982. This
rule was scheduled to become effective
on July 12. 1983. The rule covers the
scope and applicability of section 5
reqwrements; the general procedures for
submitting notices; information
requirements, including a mandatory
notice form: and EPA’s procedures for
processing information contained in the
notices, including confidential business
information.
On June 17. 1983. the Chemical
Manufacturers Association (CMA)
petitioned EPA to stay the effective date
of the PMN rule for 90 days to provide
EPA time ‘to clarify and modify the rule
in several respects. CMA stated that.
without clarification and possible
modification of certain rule provision.,
the rule would Impose an undue burden
on its member companies. CMA
particularly expressed concern about:
(1) Tb. research end development (R&D)
exemption, (2) the PMN notice f , (3)
information requirements on polymer
identity. (4) the submission of test data.
(5) the submission of data on related
rh i d aJs (6) the submission of
dedcrlptions of risk assessments. (7) the
procedures for declaring PMNs
“incomplete,” aid (8) the definition of
“possession or control.” In a
memorandum accompanying its petition,
CMA also raised questions about
Information requirements on use and
manufacturing operations, the possible
release of cosfldai tisl chemical Identity
included In health and safety studies,.
the tIming of substantiations of
confidential chemical Identity, the
submission of generic use descrlpllosm.
and the timing for submitting notices of
commencement of manufacture.
In addition, on june 27, 1983, the
Society of the Plastics Industry (SPI)
submitted a petition to EPA to stay the
effective date of the PMN rule. SPI
raised two Issues concerning polymer
information requirements—the
requirements that the average molecular
weight and percentage of low molecular
weight species be estimated and that
monomers and other reactants used at
less than 2 percent by weight be
identified,
In response to these petitions. EPA
postponed the effective date of the rule
for 80 days. so that it could review the
rule language and, where necessary.
clarify ambiguous points or revise
specific provisions. This postponement
was announced in the Federal Register
of July 11. 1983 (48 FR 31641). During the
postponement period. EPA has received
further comments on the issues raised in
the CMA and SPI petitions from SPI.
CMA. the American Chemical Society.
and the National Paint and Coatings
Association. The CMA and SPI
petition.. as well as these subsequent
comments, are included in the public
record on the PMN rule.
IL Summary of Action
hi this notice, EPA announces that the
major provisions of the TSCA section 5
Pt .Q4 rule will go into effect on October
28. 1993, In addition. the notice
awiounces the followtng’actlons with
re ect to the rule: (1) The stay. pending
further consideration and rulemaking. of
54729.38 and 729.78 (requirements
ceecerning new nh. .nI el substances
manufactured under the section 5(b)(3)
R&D exemption), I 720.3(y) (the
delnitlon of “possession or control”).
and * 72010(c) (dat. requirements on
related cbmsianl.). and (2)a
nensubstantive amendment of
I 720.193(bfli) ( tM Ing of submission of
the notice of c” csment of
menufacture). EPA Ii also clarifying
suera) other previsions of the rule
(primarily those concerning polymer
Information requirements. test data
requirements, and Information
requirements on risk assessments and
uses), and explains why the Agency
believes that other provisions Identified
as a concern by CMA—such as the
mandatory form and incompleteness
provisions—do not require revision.
accept for the sections that have been
stayed, the final rule will go Into effect
on October20, i9eS. All PMNs received
on or after that date must be submitted
- on the PMN form. and notice submitters
m comply with the provisions of this
nile that are In effect These provisions
Incisde all the major notification and
premdural requirements of the PMN
rule, such as the mandatory form, test
data and Information requirements.
procedure, by which EPA can declare a
notice Incomplete, and confidentiality
procedures.
With this notice, therefore, the basic
provisions of the PPiQI nile will go into
effect. These requirements will promote
standardized PP.Q4 reporting and
iecsrdkeeplng procedures they will
allow EPA morti effectively to address
the increasing number of PMN. It i . now
receiving and they will ensure
consistent enforcement of section 5
provisions. The temporary
postponement of provisions concernin
R&D, “possessIon or control,” and dat.
EXHIRIT 4

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41i40 Federal Register I VoL 48. No. 178 I Tuesday. September 13. 1983 1 Rules and Regulations
the potential eflects of impurities in the
substance. byproducts of manufactire or
use. environmental transformation
products. iind similar related chemicals.
as well as data specifically on the new
chemical substance. Al the same time.
however. EPA awees that monitoring
and exposure data on “related
chemicals” need not be submitted.
unless these data are directly related to
the proposed maniffactine. processing.
distribution, uses, or disposal of the
substance (e.g.. they wele developed
during R&D or test-marketing activities).
In revising * flO.50(c) of the rule. EM
will solitgt public comments on these
issues mid eddies. mom ámctly the
exact infotesatla. re ements on
related ds cah.
In at least one me t , CMA’s
concerns oees datarequimaienta for
related d ie”isals sines from a
miuwidaistendiug of the nile. CMA
apparently beliored that the test data
themselves, rather than d isalptoas ,
were reqiiked if Lbs data were
unpLIh1 ..1l .k and timi standard
literati wore raqtauad for
published data. However. I 720.50(c)
requires only d.i .w pHa i . of
unpublished data n related h nIp 2i
(i.e., adssaiptlonof the typeofdata
and a sn ’y ofiendts), and It would
not have required either published data
or literature reference, to published
data. These points wm be mad . mars
explicitly In any rs.lILiuI of this
section.
VI. Noauubstaatlve m.&IiauI 5
Section 720.i02(b)(1) of the May
rule would have xequized manufacturers
or importer, to submit a n8tlce of
commencement of manufacture or
import “on the first day of such
manufacture of lmport. In the
memorandum that accompanied its
petition. CMA stated that compliance
with this pvvv6ion may be very difficult
because of “coordination difficulties or
the pines of other business.” At the
same time. EPA recognizes that,
altho s It isimpcrtaaflhst sew
chemical substances be entered c i the
TSCA s fiM
coa . 1 . al mai ’ ’ e (es that
subsequent mmafa er. mm keow
they are not subject to .V1
requirementa and tc 1 . . t
inmecessary EM review oU.pIi tlve
PMNs) it makes relatively little
differemm whether notification of
commercial . nanuIn ?iu the
first day of manufacture or shortly
thereafter. Therefore. A halieims that
cmnpanis..h nIdbe allmii.daome
latitude In when they submit notices of
comme - t of iwuifactme. and
that notices s.hDtad a shari time after
manufacture begins should be accepted.
At the same time, however. EPA
believes that companies should not be
allowed to submit notices before
m.anufacture begins; only chemical
substances actually in commercial
production should be added to the
TSCA Inventory.
For the above reasons. EPA is
amending I 720.102(b)(1) to read.: •if
maruilacture or import for commercial
purposes begins on or alter the effective
date of this rule, the subnu er must
subout the notice to EPA on. or no later
than 30 calendar days after. the first day
of such manufacture or import.” This
amendment is a.I*tant with several
comments received dii ng the public
comment period on the proposed P
rules. This !1I ltgP is a technical
amendment one miner procedaral
aspect of this interpretive ride and dies
not require further notice and comment.
The amendment does not work tithe
disadvantage of any PMN submitters,
and it does not in any way Impair EPA ’s
ability to protect th. public and the
environment from chemicol hazards,
Further com ant Is unnecessary.
As indicated in EPA’s ‘ Inetriactions
Manual for Preaamdactair. Notification
of New Cboi 1 Smabstancee,” nodes.
of commencement of manufacture
should be submitted toi Document
Control Office., Office of’toxlc
Substances (TS498), U.S.
Environmental Frotadice Agency. 401 P4
SL SW. Wa Ington. D.C. 20980.’To
ensure that notices of
are sent to the p .op *dthues ,’EPA is
adding this ad4r to the tole as
I 720.102(d).
V Pubklecord
EPA has estabI’. 1 a public record
for the PP.Q( rula. . .alrhig (dockt n mher
OFFS-s0002L whids Is availa hi. for -
inspection in Rin. E-1 , 401 M St. SW.
Washington. DC. 30460 from 8 0 a.rs. to
4:00p.m., Monday through Friday.
except legal holidays. Persons who do
not have access to the public reading
room should contact Jach P. McCarthy,
Director. TSCA Assistance Office (TS.-
799). at the address given earlier hi this
notice.
Th. following Information related to
thin revision and darølcstlon has been
addediothereurrit’
(22) USEPA-O1 “Premanufacture
Notificatloit Prsmannfscture Notice
Requirements sad evlew Procedures,
48 FR 21722, dated May 13 1183.
(21) ChemIcal Maud clu
Association ( 4A), ‘‘PetItion for a Stay
of the Final Ruleand Notice Form
Implementing the Preusamdscturs
Noti&aUse iRsqulrsmeiits of the Toxic
Substances Control mt , ” dated Fete 17,
1983.
(24) SocIety of the Plastics Industry.
Inc. ISP !). PetiUen of the Society of the
Plastics Industry. Inc. for aStay of the
Final Rule and Notice Form
Implementing the Premanufacture
Notification Requirements of the Toxic
Subs tdnces Control Act and a Request
That Rule Making Be Reopened.” dated
June 27. 1983.
(25J USEPA-OTS. Transcript of public
seminar on premanufactuze notice
requirements, dated June 23, 1983.
(26) SPL Letter to M. E. Williams.
Acting Director. Office of Toxic
Substances, dated July V.1983.
(27) National Paint and Coatings
Association. Letter tot. DeSantls, Office
of Toxic Substance., dated July 28. 1983.
(28) American Chemical Society
(ACS). Letter to D. It. Clay. Acting
Assistant Admirastralor. Office of
Pesticides and Toxic SubeLc . , . . , dated
July 28, 1963.
(29) CMA. Letter to D. R. Clay. Acting
Assistance Administrator, Office of
Pesticides and Toxic Substances, dated
July 29,1983.
(30) alA, Letter toO. It. aay. Acting
Assistance Administrator. Office of
Pesticide. and Toxic Substhn , ,., dated
August17. 1983
(15 USC. 2905)
IMI of Subjects I i 40 RPaI9 28
micsis, L.i. — tul disst .
Piemanthetess nod1k Henardesm
matedaL sad
requlsemeata.
Datedi SepL,.b.8 . 1185.
WIllbmftV . t” —
Admmnistmtcj ’.
PART 728 .—(AMEIIDEDI
Therefore. 40 CFR Put 729 Is
amended as followsi
H 72O. 7*36w 720.50, aid 730.7$
( ewJs4I
i.Th. effective date of * 17 2 9.3(y).
720.36,720.50(c), and 720.78(b) is hereby
stayed until further notice.
L1n 1720.102 ph(bllhJls
revised and (d) Is added to
read as followm
I 720.103 N &s ot cmma.,.....wti of
• • I I •
(bJ I4lten SozeporL (1) If manufacture
or import for commercial purposes
begins on or alter the effective date of
this rule. the submitter must submit the
notice to EPA on. or no later thea 30
calendar day., after the first day of such
manufactuss or Import.
(d] lilsele to ;ubmit, Notices of
c’ ” ncement of manufacture or
Import should be submitted tm
Document Control Officer. Office of
Toxic Substances (TS-793). U.S.
Environmental Protection Agency, 4 M
St.. SW., Washington. DC 20460.
ire o. o-wsi Fihd e.ia.o . s .mj
cam

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iMQO Federil Resist I Vol. 51. No. 77 / Tuesday. April 22. 1988 I Rules and Re Iauon ,
documa8 thaw own activitia. They
are oct ,,qoged by this rile to mamtain
records d uBn1 what — mu of
an R&D maba’ aIW tbw asu
activities iri COPISI aid they so
lon et have cannel .1 the abstance.
The pinvimon that miMfectw,
retain specific record. whes an R&D
substanc. is distributed to other pereons
does nos apply if the substance is
i tcorpcnted into an crude or exists in
a (inai product as an impurity. If an R&D
substance produced at more than 100 kg
per year is incorporated into articles in
the course oF R&D or is included na
product as an unpw,ty. manufactwsn
must record the duposition of the
substance in the article or the final
product aauming the substance is
produced at more than 100 kg per year).
but they ate not specifically required to
document the disposition of the aiticlee
or products themselves. or the names
and adthsss.. of the pureess to whom
they as. distributed. In addition. the
specific quantities involved an sot
subject to the notification r.qwrements.
of 720.311c1(2 ).
Beyond the specific records required
by the rule. manulacninrs aid
importers who conclude hey are exempt
from P? IC4 requirements fore chemical
substance seed for purposes of R&D
should be prepared to justify the nature
and scope of he iracttvtdes WA notes
here that. althmiaji the ftnal rule does -
not requ Ire manidacturer, and Importers -
of R&D substance, to maintain record.
demonstrating that their activities
constitute legitimate R&D. the burden of
proving eligibility for the R&D
exemption. as for any specific
exemption from an otherwise applicable
general statutory requirement rests with
the person claiming the exemption. WA
advises manufacturers and Importer, of
R&D substances to be prepared to meet
this responsibility should a qa.rstien
arise concerning their compliance with
the general requirements for PIC4 or the
exemption for R&D.
8. Data on Rufated C 5omicai.
EPA has reexa d the pnpiiud
requirement In I ? .*s) pub 1 K 1 to
he Fedeisi 1e situ : .1
27.1988(88 FR & that emeom
submitting a 4 suu e the A
with unpublished date en the ‘echh and
environmental effects of thio.k. such
as byproducts and faede’ rk& which are
relatid In the cases of pes il 1 to the
new ‘ micaI substance which ta the
focus of the QI. While 1n $(d$1)
(B) and(C) of1 CAgents EPA
broad authoulty to require ash data,
WA finds that It Is neceemey to
exercise this au*cVdy to the ems of
every new chemical aubst For most
review, of new substances, published
data on the health and environmental
effects of related substances and data
submitted under section e) will su ce
to enable EPA to evaluate risks.
Should the Agency determine that
data on elated chemicals are es.ential
to its review of a particular w
chemical substance, it will request the
additional data from the submitter, a
procedure recommended by the
Chemical Manufacturers Association
(CMA). (a a comment on the proposed
rule. CMA wrote that in the event EPA
required unpublished data on related
chemicals. EPA could ask the P 4
submitter to search for he data the
Agency needed to complete its review. If
such data are available, the P%C4
submitter could provide them to WA on
request.’ This approach will provide a
flexible method of secwlng information
n.e ary to conduct premanulacture
reviews. Accordingly. the requirements
off Tso.50(cI have bees deleted. WA
points out. however, that It Is In the
interest of submitters to provide the
Agsncy .wuth a full descrtpftcn of .11
available data relevant to a itch
assessment of the chemical substance
that is the focus of the P! C4. Failure to
provide this Information, white It Is
Important to assessing Isk. may
unnecessarily delay review of the PI .Q&
potentially leadIng to extension of the
review petted and possible action.
EPA also reminds sisnufeciwir, and
importers that existing provisions of the
C4 tile still require them to submit
certain information about related
chemicals. Under I 7 .4I of the 4
rule. pasa aph (b) requires reporting of
the identity and volume of Impwtaeu ,
and parugreph (d) requires deamiptions
of bypsoducts roe.lttng from the
. u. ufacture . pioceesuig. and i.e of the
new chemical substance. In addition.
section e) of TSCA requires ____
manefahiu ere and Imports ,, to provide
EPA with any tnloruiatios which they
obtain which . mp ite the conchislos
that a substance or mixture pies..nts a
substantial risk to health or the
environment.
C Pouiu ion or Control
—‘ — 34b)(1)(BJ of TSCA and
I 7a50 of the P144 nile require_____
manefaai. .... and Impmlors to
.U health aid environmental . .ffacts test
data on the now Ia .udal substance in
ir ‘pasesslen or . . .ts.L ” In
addition. I 7 JS(bK1$l) rs ms
manulaeasuie or apart., of R&D
subs’ua” to evabmte metM
Informati o n is their pe u or
to meet requli sts for the
exp heMD.EPAbasmed.a
slight change in the langeege of
I 720.3(y) from lie proposed rule
clarify that data in a manufacturers or
Importer’s poeeession or control include
data In thefilee of its agents who are
engaged us R&D. test marketing or
commercial marketing of the substance
to the extent that th. files are kept in
that persas’s capacity as an agent. EPA
considers thea selected rnips of
individuals. who work under contract or
special anangemern for a manufacturer
or importer on a specific project, to be
under that company s control for the
scope of the prouect. Companies must
request that the Ales of ths qencs
engaged in such work be searched for
daip en health and enviroiunernal
sffscts relevant to the activities hey are
under contract to pursue. EPA also
includes within the scope of data tn
“possession or control” the files of
persons engaged in research.
development, test marketing or
commercial marketing of a new
pk. Ii I substance, and who are
employed by companies associated with
the submitter of the P? 1 but which are
located outside the United Slates. inlets
the laws of the foruige nation forbid
such a search.
fl *O,ly Cit anicoI•
Simian U(s) of TSCA exempts from
P?.Q 4 sew chemical substances which
are manufactured or processed for
export only and will not be uied in the
U.S. The proposed revision off 720 3 (31
would have limited processing to
activities occurring under the control of
the maeuhcnirsr or importer In this
final nile. WA modifies the defuut:ori of
the term “manufacture solely for export’
to Include processing which is not under
the direct control of a manufacturer or
Impertu.aslonguitocctin solely for
expest. (The nib avss.efsrences the
definition of ‘process solely for export
in 40 R 721.3.) However. the
“ “ ctu,or must know. by means uf a
contract or same other evidence, that
the processing is occurring for export
only. For substances to qualdy as
expoet.only chemicals. their processir.g
must ales be limited to activities wnLcn
do not involve use. For example.
formulating a mixture constitutes a
legi te form of processing for export.
oily ‘ 4’ i” but their use as
Intermediates in chemical production
dose sot.
i 1 .oIIoe of Commencement of
Marwfe ir,
As diuuud earlier in this notice.
EPA allows a manufacturer or importer
to use R&D wmial far twn ’R&D
cosslal purposse only alter
.o.plsdas of the PIiDI review period.
Exhibit 5

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F.d&sl / Vol. SI. No. 77 / Tuesday. Apr 11 22. 1016 / Rules and Reg 1ati 3
except as ds.atbed in $72100 (d) and
(I). EPA hu received querIes about the
timing of iotiSc*tic of commeucement
of manufacture in cuss whir, P%*I
review has been . .uw,latsL but the
‘namdactig,r intends to begin non•
exempt commercial activiltes with
quantitIes of he new disiwcal
substance previously produced for
purposes of R&D.
EPA requires persons to submit a
notification of commencement of
manufactur, within thiny days of the
stan of non.exempt commercial
manufacture of a new substance. If
amounts of the new chemical produced
for R&D already emit. a manufsuiwer or
importar may use them for non.exumpt
commercial purposes as soon as the
PMN review is complete, but that person
may not submit a aotiftcation of
commeuc nt of manufacture until
actual non ..xempt manufacture begins.
Section 721102(a) hu been revised to
reflect this. In addition. even after the
PMN review period ends the new
substance may be muufactured solely
for R&D or solely for expmt. In that
the manufacturer or Importer.
• submit a. notice of
- ..i
• . ..
non . mpt manufacture occers.
IlL Ru — -’g lacoed
EPA has established a recuti for this
rulemaking ( dnek.t number OPTS-
5W71j . which Is available for
inspection in Rio. S-107. 401 M St.. SW.
Washington. DC 20460 . hems sm. to 4
p.m. Monday through Friday, except
legal holidays. Persons wh . do not have
access to the record In the public
reading room should contact Edward A.
Klein. Director. TSCA Assistance O s
( ‘TS-799J. a: the above address for
assistenno.
The record includes Information PA
considered in developing this .u1s The
record Includes:
1. This notice and P 4 doc’tr iiti
cited In this notice,
2. Public comm*.
3, 9uiui ,i. 4s, of meetings with tsad.
associations, public lateNt sqs, and
other coups.
4. di ac
5. Survey of research and
development activities cgs ’i.c’ ed by
chemical Rims
s All communications b.t a PA
and persons outside the Agency
per•”” igtothsdevelepmensdths
rule.
7. A document responding to public
comments.
IV. Regulatory A:t
A. £recutive Ordu i i
Und Executive Order 12201. EPA
must determine whether a title is
“mapoV’ and therefore requires a
Regulatory bnpacz Analysis. EPA ha.
determined that this tithe Is not major
because it would not have an effect of
$100 million or more on the economy.
The u ale will not have a sigzu8cant
effect on compstttion. costs. or prices.
EPA submitted this nile to the Officeof
Management and Budget (Ohs) for
review as required by Piticutive Order
12291.
9. Ragulotoay Raxfb,Ifty Ad
As reqtWed by the Regulatory
flexibility Act (S U.S .C. 506(b)), EPA has
assessed the impact of this rule on small
businesses. EPA has determined hat
once the rule .L1i g involve, relatively
minor revisions to the Bual PIiQJ rule, it
will not oreate additional Impacts on
small bosinsiss over those already
idenNted I nthsflm lMlguIs.4IFR
21722.
C Pqparwork RMiction Mt
The information provisions In this title
are a best of the InA ismatios
collection reqiate..’ut . of lbs C4 rule,
which has already bees cleared by OhS
un the Papsiwork Redaction Ace 01
1110.44 U.S.C. 3001.5 seq. OhS oss ol
number is ZWO .gOl&
r Ical& Eavli tal protection.
Premanufacture notification, Hwidons
materials, R.cordkespsng and reporting
requirements.
Dated: AptI 7. tIN.
IasM.P—--i.
PART 720—4A151DJ
Thsefo . 40 ai Part 720 15
amendsd’u follows:
I. The authority citation far Part 7201$
revised to read an follows:
A Ily 1$ USC. 2505 0I . and MS.
2. In $7213. paisç.phs (5) and (y) are
revised to read u fellows:
iim 0 t 1JU
• • • I I S
(s) Manufactu, solely for upcst
means to manufactwu or Impart for
commercial p rpoeee a
substance solely for ,art from the
United States under the foU .wlag
restrictions on activities In the Ulaltsd
States:
(1) DIstrIbutIon In commerce Is limited
to puiposes of export or pro’ ‘i
solelyforIxrtasde , in * 72fl of
this chapter.
(2) The iufacturer or tmporta -
any person to whom the substa 1
distributed for pwpoee. of expc’
processing solely for export (as a nrt
in I 721.3 of this chapter). may not use
the substance except In small quantities
solely for research and development ui
accordance with * 720.35.
• I I I I
(y) ‘Possession or control” means in
possession or control of the submiuer.
or of any subsidiary. paruiership in
which the submitter is a general partner
parent company, or any compaay or
paruiership which the parent compeny
owns or counols. if the subsidiary.
parent company. or other conipmy or
paruiership is associated with the
submitter at the research, deveiopmen,.
t marketing, or commercial marketing
of the rhemical substance in question.
(A parent company owns or controls
another company if the pm-ens ewns or
couar 1 la 00 psr eot more of the other
company’s voting stock. A parent
‘ wpaiy owns c i coonolo any
parmuislep m which it Is a general
partoer). information Is included witha
this definition d It Is:
(I) In lies maIntained by mibnutier’s
employees who arm
(I) Associated with research.
dsvslepioeat. test marketing. or
commercial marketing of the che
substance In question.
( ii) Rasonably likely to have su i—
data.
(2) MaintaIned in the files of ocher
agents of the submitter who are
associated with research. deveIopmeri .
test marketing. or commercial marketing
of the h.micaI substance in quest:on in
the course of their employment as sucri
agents.
• S S I
3. Ia I 72130. paraçaph (a) ii revised
and pat sph (I) is added to reed as
follows:
* hISS CB.,,&..,. let suh$ ect te
nituL-Di mqi$smaate
• . I S I
(e) Any new chemical substance
manufactured solely for export ,f. whe i
the substance is disutbuted in
(I) The substance Is labeled in
accordance with section 12(a )(1J(BJ of
the Act.
(2) The manufacturer knows that the
person to whom the substance is being
distributed Intds to export it or
pru oss it solely for export as defined ri
* 725.3 of this chapter.
• I S S I

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Fud.nl Raçst.r / VoL. 51. No. / Tii ay. Aprü 22. 1911 I Rules and Requlatior.,
l5 f 3
(iv) The names and adési sot any
persons othir than the anfactwer or
importe, to wbo the substance is
distitbuted. the idsn ty of thu substance
to the extant koow the amount
distitbuted, and copies of the
not*Acatjo s required under
I 7 20.3 1(c)(2). These records are not
required when substance. are
distributed as impurities or incorporated
into an article. in accordance with
parapapk (d) of this section.
(2) A person who manufactures or
imports a chemical substanc, under
I 720.31 and who manufactures or
imports the substance in quantities
pester than 100 küopsms per year must
retain records of the idendty of the
substanc, to the extent known. the
production volume of the substinc ,. and
he persons disposition of the
substance. The person is not required to
meintarn records of the disposition of
products containin$ the substance as an
unpustty or of articles incorporating lie
substances.
(3).Records under this parspeph must
bst fIined for $ years after they are
developed.
• • S S
7. La 720.102. parapaph (a) ii
revised to read as followL
f 7*111 . of csrenanssm.n of
FseWs er U’upafl .
(a) Applicability. Any person who
commences he manufacture or import
of a new chemical substance for a
nonexsmpt commercial purpose for
which that person previously submitted
a section 3(a) nottce under this Part
must submit a notice of commencement
of manufacture or import.
• S • • •
(FR Dec. 554525 Fd.d 4—Z14 5 543 sin)
cow

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I

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Existing Chemical Assessment Division
TSCA Section 5(a)(2)
Significant New Use Rules for Existing Chemicals
What Are Significant New Use Rules?
Section 5(a)(2) of the Toxic Substances Control Act (TSCA) allows EPA to designate, through a rulemaking
process. some or all uses of a chemical substance as “significant new uses.” Such rules are known as Significant
New Use Rules (SNURs). Subsequently, persons who intend to manufacture, import, or process such substances
for a significant new use must notify EPA at least 90 days before commencing that activity. The Office of Toxic
Substances (01’S) evaluates such notices and can, if necessary, take immediate action to prevent or modify the
intended activity.
How Can SNURS Be Used to Control Health and Environmental Risks?
In cases where EPA believes a substance may be hazardous to human health or the environment, and the
uses identified may result in significant exposure, Section 5(a)(2) directs EPA to evaluate the intended use(s),
and monitor the potential exposure and risk. If necessary, EPA can prohibit or limit that activity until adequate
data have been developed and evaluated to determine health and environmental risks. Where unreasonable
risks are found, EPA may take immediately effective control action to prevent such risks.
For further information regarding TSCA Section 5(a)(2), please contact:
Frank Kover
Chief, Chemical Screening Branch
TS-778
U.S. Environmental Protection Agency
401 M S;reet, SW
Washington, DC 20460
Telephone: (202) 382-3436
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88

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M

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Agency Wasn,ngtori D.C. 20460
Toxic Substances
EPA The Toxic Substances
Control Act
Public Law 94-469
Reporting for t
Cheniic I Substance
Inventory
Instructions For Reporting
for the Revised Inventory

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Reporting for d ii
Partial Updat g of tis
Date B s
TSCA
‘p-

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Answers
to Your Questions
About the
TSCA Section 8(c) Rule
0
Of lice of Toxic Subst6nces
Environmental Protection Aqency

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Teuc 3 ”c.s
D.C.
o mmbef t9$$
1’o ,c SubiCis
NEW CHEMICAL
INFORMATION BULLETIN
Exemptions for
Research and Development
and Test Marketing

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Mc

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TSCA CBI CLEARANCE
SUPPORT FOR TSCA ADMINISTRATIVE ACTIONS SEP 7 I9 39
CBI CM CLEARED
REGION CLEARED REGIONAL HEARING CLERK DOCUMENT CONTROL OFFICER(S) COURT REPORTER
NO Mariana Browning Dickinson James P. Owens, ii:i No
EPA Region I
J.F. Kennedy Federal Bldg.
Boston, MA 02203
FTS 835-3451
II NO Karen Maples Garcia Abrines .No
EPA Region II
26 Federal Plaza
New York, N.Y. 10278
FTS 264-9881
III YES Suzanne Canning Douglas White, Atty No
EPA Region III Ed Cohen
841 Chestnut Building
Philadelphia, PA 19107
FTS 597-8913
IV YES Marsha Dryden Bob Stryker No
EPA Region IV
345 Courtland Street, N.E.
Atlanta, GA 30365
FTS 257-2681 or 257-8913
V YES Beverly Shorty Beverly Shorty No
EPA Region V
230 South Dearborn Street
Chicago, ILL 66064
FTS 353-1669

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TSCA CLEARANCE crp
SUPPORT FOR TS DMINISTRATIVE ACTIONS
CBI CBI CLEARED
REGION CLEARED NAME DOCUMENT CONTROL OFFICER(S) COURT REPORTER
VI YES Carmen A. Lopez John A. West No
EPA Region VI
1445 Ross Avenue
Dallas, TX 75202-2733
FTS 255—2115
VII YES Linda McKenzie Gary Bertram No
EPA Region VII
726 Minnesota Ave
Kansas City, KS 66101
FTS 757-2853
VIII YES Joanne McKinstry Kathy Diclementi No
EPA Region VIII
999 18th Street
Denver, CO 80202-2413
FTS 564—7592
IX NO David Carison Robert Peterson No
EPA Region IX
215 Fremont Street
San Francisco, CA 94105
FTS 454-8600
YES Marian Atkinson Jonathan Heller No
EPA Region X
1200 Sixth Avenue
Seattle, WA 98101
FTS 399-1078

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sPip
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINJGTON. DC 20460
4P4 ,
nfl w-r rr
rcnrIpr
AUfl 1 6 1 (139
MEMORANDUM
SUBJECT: Availability of Miller Reporting Company,
Access to TSCA CBI
/,/• /..“
FROM: Linda A. Travers, Director q, ’?/4 /“
Information Management Division 17
Office of Toxic Substances (TS—793)
TO: Frederick Stiehl
Assistant Enforcement Counsel
Toxics Litigation Division (LE-134P)
This memo is to inform you that the TSCA access available to Miller
Reporting Company has been revised to allow Miller to work under
all sections of TSCA, and any in program area. Previously, Miller
had been cleared for all sections of TSCA, but only for cases
involving biotechnology.
Miller Reporting is constrained to performing transcription work
in a secured area at EPA headquarters. Offices using their
services must provide appropriate space as required in the TSCA CBI
Security Manual. All applicable TSCA security requirements must
be adhered to when using Miller Reporting Company services.
A copy of the Federal Register notice is attached for your
information.
Attachment

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Federal Register I Vol. 54, No.128 / Thursday. July 8. 1989 1 Notices
284?
Lu pay are set forth under Appendix A of
the filing.
Texas Eastern also submits for filing
us a part of its FERC Gas Tariff. Fifth
Revised Volume No.1. six copies of the
following tanff sheets:
Substitute Sixth Revised Sheet No 72.
Substitute Sixth Revised Sheet No. 74.
These sheets are being filed to correct
a typographical error in a fihng made by
Texas Eastern on Apnl 21. 1989 in
Docket Na. RP8O—150-000. The tariff
sheets filed Apnl 21 inadvertently set
forth incorrect .illocation factors for
Carnegie Natural Cds Company and
Midwest Natural Cas Company. The
woikpapcrs under Attachment A of the
April 21 Iilrng set forth the correct
allocation factors, which the above
listed sheets reflect. The monthly
principal amounts do not change.
Texas Eastern requests that the
Commission permit the tariff sheets to
become effective May 1. 1989. Copies of
the filing were served on Texas
Eastern’s junsdictional customers and
iuiterested state commissions.
(upies of the filing were served on
Texas Eastern’s jurisdictional customers
and interested t te commissions.
Any person desiring to protest said
filing huuld file a protest with the
F derel Energy Regulatory commission.
U 5 Ninth Capitol Street. NE.,
Washington, DC 20426, in accordance
with Rules 211 and 214 of the
Coniiiiissiun’g Rules of Practice and
Procedure. All such protests should be
filed on or before July 7, 1989. Protests
will be considered by the Commission in
determining the appropriate action to be
taken, but will not serve to make
protestants parties to the proceeding.
Parsons that are already parties to this
pioct’ading need not File a motion to
intervene Copies of this tiling are on file
with the Coniinission and are available
br publu inspection
Luis El Casnrll.
.SeLn ’tnry
ll’k Dub. li —I5U05 Filed 7— 9, 8.45 cm l
biLLiNG CQDE.67I7.Oi..
ENVIRONMENTAL PROTECTION
AGENCY
IOPTS- 140116; FRL-3611—5 1
Access to Confidential Business
Information by Miller Reporting
Company
AGENCY: Environmental Pro!eLiiun
Agi. ’iicy (EPA).
ACTION: Notice.
Washington. DC. access to information
which has been subiniu ’d to F.P.\ wider
all sections ol the l’cjxtc Su i ...iices
Control Act (TSCA). Some of tie
information may be claimed or
determined to be confidential business
information (C I I I ).
FOR FURTHER INFORMATION CONTACT’.
Michael M. Stahl, Director. TSCA
Assistance Office (TS—799). Office of
Toxic Substances. Environmental
Protection Agency, Rm. EB—44, 401 M St..
SW., Washington. DC 20460. (202) 554—
1404, TOO: (202) 554—0551.
SUPPLEMENTARY INFORMATION Under a
procurement. MRC. 507 C St.. NE..
Washington, DC will assist the Office of
Toxic Substances, the Office of the
Administrative Law Judges. and the
Office of Enforcement and Compliance
Monitoring in providing reporting
services for administrative hearings that
will require the review of information
that may be claimed or determined to be
C I II.
EPA is issuing this notice to inform all
submitters of information under all
sections of TSCA that EPA may provide
MRC access to these C DI materials on a
need.to-know basis. Authorization for
access by MRC to TSCA CIII, under this
procurement was previously announced
in the Federal Register on August 25,
1988 (53 FR 32442). All access to TSCA
C DI under this procurement will take
place at EPA Headquarters facilities.
Clearance For access to TSCA C LII
under this procurement is scheduled to
expire on July 14, 1990.
MRC personnel will be uequired to
sign non.disclosure agreements and will
be biiefed on appropriate security
procedures before they are permitted
access to TSCA Clii.
Dated June 23. 1989.
Linda A. Travers,
I),rrt.u,:. IszJ.ar::uit,ins .‘ lu,li. .. ’,’i., ’iii ! Ji I I1Ii?
i.’ vi lu’,,. .SO1I.t( isi
IFK Doc aii—isatja Fikd 7-5—aq a 4S a,ii
ai uaG CODE essa-so-is
I OPTS—S 1734; FRL—36 11—71
Toxic and Hazardous Substances;
Certain Chemicals Premanufacture
Notices
AGENCY: Environmental Protem twn
/ageiic.y (EPA).
ACTION: Notice.
SUMMARY: Secton 5(afll) of the Toxic
Substances Control Act (TSCA) requires
any pei on who intends to manuf.ictuie
or import a new chenucal substance to
— submit a prcmanufacturc notic.e (PMN)
to EPA to lc,tst 110 days tniorc
tii.uciuf.iu:tui i’ or import cunirnrnri’s
St.ttutory ru uirt’r:t i’ t’ f.ir .tction
I ‘
i . , Li..
Fudcral k gistec of M a) U. LIJoJ
21722). This notice announces receipt ut
105 such PMNs and provides a sumin.iry
of each.
Dams: Close of Review P rzuds
P 89—681—August 2. 1989
P 89—692—July 30. 1989.
P 89-693. 89-694. 89-695. 89—t io. 1 19—
697, 89-698, 89—609. 89—700.89—701—
August 5. 1989.
P 89—702—August 6. 19th ).
P 89—703—July 21, 1989.
P 89—704. 89—705—-August 6, I ’J89.
P 89-707—August 7, 1989.
P89-708.89-709.89—710. 89-711, 119-
712. 89—713. 89—714,89—715. 89—716—-
August 9. 1989.
P89—717.89—718,89—719. 89-720, 119-
721. 89—722. 89—723. 89—724. 89-725—
August 13. 1989.
P89-726. 89—727. 89—728——August 14.
1989.
P 89—729, 89—730—August 15. 1989.
P 89-731, 89-732, 89—733. 89—734. 89’-
735—August 16. 1989.
P 89—736—August 9, 111119.
P89—737. 89—738. 89—739. 89—740. 89—
741, 89-742—August 19. 1989.
P 89—743. 89—744. 89—745. 89—740 41i
747. 89—749——August 20. 1989.
P89-750-August 21. 1989.
P 69—751, 89—752, 89—753-—A ugu’
1989.
P 89—754. 89—755. 89-756. 89—757. 89—
758, 89-759. 89—760. 89—761—Augusi 23.
1989.
P89—702. 89-763, 89—764—Aiigusi 27.
1989.
P 89-765. 89—766. 89—767. 89—768——
August 28. 1989.
P 69-769. 89—770—Auj. usI 29. 1989
P 119—771. 89-772, 89—773—August ‘JO.
11.1811.
P 09—774 89-775. 89—770—St’ 1 iii ’,iuliii
2. 1989.
P 89-777, 89—778.119—779, 89—7110. 89—
781, 89—782. 89—783. 89—7114—S’pli’tiilii’r
3 11.8.19.
P 89—785. 89-786. 89-787. 89—71 18-—
Septcitubei 4. 1981)
P 89—709—Sepleriiber 3. 1989
P89—790——August 23. 11.11*)
P 119—7111—Septenibvr 4. 1Wi11
P 89—7112. 119—793. I19—7114—Si’plrnilui r
5. 1989.
P Li11—79t Septeniber 6. 111)19
P 89-797—September 9. 11189.
P O9-7’Jli—SrptemLicr 11) 19)19
bJ”
P1i9—691—July3. 1989
P89—692—June 30. 1989
p 89—693. 89—4194, 1J9—(j ’15 )i1I—( ’ ) 11”
(.17. 8’)—698 ift)-.4,9’t fl9 7()() iI!i—’(iL
6, 1’)Il’I
SUMMARy: EPA has auiharizu.d Muller
l(i:iniri uig Company (MRC).

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UNITED STATES ENVIRONMENTAL PROTECTION AGEN V
WASHINGTON. D.C. 20460
August 22, 1989
OFFICE OF
________________ THE ADMINISTRATOR
TO: Mr. Michael Woods, Director
Compliance Division
FROM; Mrs. Bessie L. Hammiel
Document Control Officer
Office of Administrative Law Judges
SUBJECT: Handling of Confidential Business Information
Pursuant to TSCA Section 16 (a) and the Administrative
Procedure Act (5 U.S.C. 552, et respondents involved in
these cases have a right to file an answer and request a hearing,
to contest any material fact contained in their complaint. The
regulations also state that the answers are to be filed with the
Regional Hearing Clerks. The complaints issued reiterates this
and give the mailing addresses for the Regional Hearing Clerks.
This doesn’t present any problem unless the answers contain
Confidential Business Information (CBI) which some do. The problem
is that all the Regional Hearing Clerks donrt have CS! Clearances.
There have been occasions where these documents were handled
improperly. The Regional Hearing Clerk’s case files are from time
to time inspected or viewed by the general public upon request.
I think there may be a simple solution to this problem.
Maybe when the complaints are written, someplace in the portion
that deals with “Opportunity To Request A Hearing” along with the
address of the Regional Rearing Clerks give the respondent the
address of the Document Control Officer also, and inform them if
any part of their answer contains CBI material to forward it to the
Document Control Officer and send the Regional Rearing Clerks a
sanitized version.
Thank you very much for any help you may give us
in informing your staff of this procedure or maybe they may
come up with a better one.

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A 1 OL C 1099 Pond ‘Lnt ic jm. M D 21090/(301) 859 49OO
TELEX 87625 / FAx (301) 859-4929
September 5, 1989
‘Vincent Giordano, Evq
Toxic. Litigation Division (LE 134P)
U.S. Environmental Protection Agency
401 N. Street, S.W.
Washington, D.C. 20460
Re: TSCA Co o1aint
Dear Mr. Giordano:
This letter advises you that David 7. Hayes of Hogan &
Harteon will represent Alcolac in connection with the TSCA
Complaint that EPA recently filed against the company. Ws would
appreciate it if you would provide Mr. Hayss with a copy of the
Complaint, aM plea.. do not hesitat. to share confid.ntial
busines, information with him insofar as he will be acting a. our
counsel on thu matter.
,—Stn sly,

Davi 7. Phillips
Presid.nt
t n t

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O
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
_____ WASHINGTON. D.C. 20460
PMOItW
CERTIFIED MAIL
RETURN RECEIPT REQUESTED OEC 221988 P STICIOES AND TOXIC $U ITANCU
Blake L. Buss, Esq.
Jones, Day, Reavis & Pogue
1450 G Street, N.W.
Washington, D.C. 20005
RE: 3M Company CDI Claims: Docket No. TSCA-88-H-06
Dear Mr. Bibs:
EPA is requesting substantiation of all confidentiality
claims that your client, 3M Company, has asserted in the
following documents. While EPA is not required by law to present
cause for requesting these substantiations, EPA is initiating
this process, in connection with the TSCA administrative
enforcement action captioned as Docket No. TSCA-H-06, as part of
its continuing responsibility to ensure that the Agency is
expending its resources protecting as confidential business
information (CBI) only that information which actually is CBI.
EPA is seeking to reduce the administrative burdens associated
with the present enforcement action which result from handling of
documents as TSCA CDI, by establishing exactly which information
is entitled to CBI protection. The documents covered by this
request are:
1. 3M Company; Answer ; Docket No. TSCA 88—H-06; Document Control
No. 20—8380163.
2. 3M Company; First Amended Answer ; Docket No. TSCA 88-H-06;
Document Control No. 20-8380163.
3. 3M Company; Second Amended Answer ; Docket No. TSCA 88-H-06;
Document Control No. 20—8380163.
4. 3M Company, Letter to John J. Nevlari, III, and Attachments
(documents and facts concerning import of Y-86-209), dated
November 18, 1986; Document Control No. MEN-162-87.
5. 3M Company; Letter to John J. Neylan. III. and Attachments
(documents and facts concerning import of Y—86-250), dated
November 7, 1986; Document Control No. MEN-293-86.
6. 3M Company; Letter to John 3. Nev].an. III. and Attachments
(requesting permission to use Y-86—250), dated September 17,
1986; Document Control No. HEN-293-86.

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7. 3M Company; Two Internal Correspondence Memoranda , dated July
30, 1986, and August 1, 1986; Document Control No. HEN—258-88.
8. 3M Company; Letter to Tony Ellis and Attachments (use
information on ‘1—86-209 and 1-86-250), dated September 4, 1987;
Document Control No. MEN—159-87.
9. 3M Company; Polymer Exemption Notice Y-86—209 ; Document
Control No. 55—8600209.
10. 3M Company; Polymer ExemDtion Notice 1-86—250 ; Document
Control No. 55—8600250.
11. 3M Company; Bonafide Intent to Manufacture , dated September
11, 1986; Document Control No. 52—8600518.
12. 3M Company; Bonafide Intent to Manufacture , dated July 28,
1986; Document Control No. 52—8600467.
13. 3M Company; Bonafide Intent to Manufacture — Followtrn Letter ,
dated July 31, 1986; Document Control No. 59—8600627...
Pursuant to 40 C.F.R. Part 2, Subpart B, Section 2.204, EPA
requests that your client substantiate its claims of
confidentiality by submitting detailed written answers in
response to the attached questions, incorporated herein by
reference. If a question is not applicable to your client’s CBI
claims, please so state, and include an explanation. This is 3M
Company’s only opportunity to substantiate its claims.
Please send 3M Company’s responses to:
OTS Document Control Officer (TS-790)
U.S. Environmental Protection Agency
Office of Toxic Substances
401 M St. S.W.
Washington D.C. 20460
ATTN: Donald A. Sadowsky
3M may claim its explanations confidential by marking the
response “Confidential”. The answers must be received within (15)
business days of your receipt of this letter. Failure to submit
the answers within this period will constitute a waiver of the
confidentiality claim. EPA may thereafter disclose the
information without further notice to you. You may request a time
extension by sending the request to the address above within the
fifteen day period.
If, based upon 3M Company’s response, EPA concludes that the
confidentiality is not warranted, the Agency will notify you of
its decision thirty (30) days prior to any disclosure.

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Please use the reference “3M Company CBI Claims - Docket No.
TSCA-88-M—06” to identify your correspondence regarding this
matter. Remember that any CBI contained in future correspondence
must be specifically marked as confidential or you risk its
disclosure. If you have any questions, please contact me at (202)
382—3536.
Sincerely,
Q L 9a44
Donald A. Sadowsky
Attorney - Advisor
Information Management Division
Attachment
cc: Ron. Henry B. Frazier, III
Administrative Law Judge (A-llO)
Jon D. Silberman, Attorney
Toxics Litigation Division (LE—134P)

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N

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UNITED STATES NVI Q AENTAL OILL.T
W A S I
it 2fl989
MEMORANDUM
SUBJECT: TSCA § 5 and 8 Concurrence Prec,ess
FROM: Michael F. Wood, Director
Compliance Divisior /
Off ice of CompliancbMonitorin
1’ /
Michael J. Walker / 1, .&
Assistant Enforcei iit Counsels
Toxics Litigation Division
TO: Addressees
The Toxic Substances and Control Act (TSCA) section 5 and
8 program has been returned to Regions I, IV, VI, VII, VIII, IX,
and X. During the past four fiscal years, this program was
implemented by the National Enforcement and Investigations
Center. Although the program has been returned to the these
Regions, Headquarters will retain its usual oversight role until
these Regions have gained a measurable degree of experience with
the statute, regulations, and enforcement response policies.
In 1986 and 1988, EPA Headquarters substantially revised
the TSCA § . 8,. 12, & 13 and TSCA § 5 Enforcement Response
Policies (ER?), respectfully. Both of these ERP5 require the
Regions to obtain Headquarters’ concurrence prior to initiating
and completing TSCA § 5 and 8 enforcement actions.
Attached for your reference are the procedures for
requesting Headquarters’ concurrence and for relaxing the ER?
concurrence requirements. These procedures establish a process
to rapidly respond to your requests. Our ultimate goal is to
relax the coflcurrence requirements as soon as each Region gains
sufficient experience in the issuance and settlement of cases in
accordance with the appropriate ERP. We are committed to
working closely with your staff - both technical and legal - to
maintain the momentum of this important enforcement program and
remain ready to assist you. Please ensure that these procedures
are made available to all staff members who are enforcing this
important reporting provision.
Attachments

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—2—
Addressees:
Director, Air Management Division; Region i
Director, Environmental Services Division; Regions 2, & 5
DirectOr, Hazardous Waste Management Division; Region 3
Director, Air, Pesticides and Toxic Management Division;
RegiOn 4
Director, Air, Pesticides and Toxics Division; Region 6
Director, Air and Toxic Substance Division; Regions 7, 8, & 10
Director, Air Management Division; Region 9
Director, National Enforcement and Investigations Center
Regional Counsel; Branch Chiefs and Acting Branch Chiefs:
Susan Studlien Region I
Wilkie Sawyer Region II
Elizabeth Spencer Region III
Bill Anderson Region IV
Michael Smith Region V
Jim Turner Region VI
Bob Patrick Region VII
Christine Phillips Region VIII
Nina Spiegelman Region IX
Deborah Hilsman Region X

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TSCA § 5 & 8 CONCURRENCE PROCEDURES
PurDOSe :
The purpose of this document is to outline:
].. The procedure for obtaining Headquarters concurrence on
Regional Toxic Substances Control Act (TSCA) section 5 and
8 Complaints and Consent Agreements.
2. Headquarters’s and Regional responsibilities.
3. The procedure for obtaining relaxation of these concurrence
requirements.
Adherence to these procedures will ensure timely
concurrence or. Regional complaints and settlement agreements,
and relaxation of tnese requirements.
Contacts :
The Headquarters concurrence process requires an
independent review by two Offices, the Office of Compliance
Monitoring (0CM) and the Toxics Litigation Division (TLD) of the
Office of Enforcement and Compliance Monitoring (OECM). Both of
thes3 offices have assigned an individual to act as your
regional coordinator. Page 4 of this memo is a current list of
)CM’s case support officers and TLD attorneys and their regional
responsibilities.
Your regional coordinator in the Case Support Branch of 0CM
has been designated as the Headquarters contact point for
obtaining case concurrences and relaxation of these
requirements. All requests for concurrence and relaxation of
concurrence must be sent to:
U.S. E.P.A. Headquarters
Regional Coordinator (e.g., John Foley, region IV)
Case Support Branch (EM—342)
401 M. Street, S.W. - -
Washington, D.C. 20460
Your regional coordinator is responsible for receiving,
tracking, and processing your concurrence requests. Each
request for concurrence will be tracked in a database.
Following the 0CM case support officer’s review, the concurrence
request will be forwarded to the appropriate TLD regional
coordinator.
In the event you have questions concerning these procedures
or the status of a request, you are encouraged to call your 0CM
or TLD regional coordinator, as appropriate. During settlement
negotiations, Regional personnel should also consult with their
appropriate regional coordinators concerning settlement

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TSCA § 5 & 8 CONCURRENCE JCEDURES
ose :
The purpose of this document is to outline:
j. The procedure for obtaining Headquarters concurrence on
Regional Toxic Substances Control Act (TSCA) section 5 and
a Complaints and Consent Agreements.
2. Headquarters’s and Regional responsibilities.
3. The procedure for btaining relaxation of these concurrence
requirements.
Adherence to these procedures will ensure timely
concurrence on Regional complaints and settlement agreements,
and relaxation of these requirements.
Contacts :
The Headquarters concurrence process requires an
independent review by two Offices, the Office of Compliance
Monitoring (0CM) and the Toxics Litigation Division (TLD) of the
Office of Enforcement and Compliance Monitoring (OECM). Both of
these offices have assigned an individual to act as your
regional coordinator. Page 4 of this memo is a current list of
OCH’s case support officers and TLD attorneys and their regional
responsibilities.
Your regional coordinator in the Case Support Branch of 0CM
has been designated as the Headquarters contact point for
obtaining case concurrences and relaxation of these
requirements. All requests for concurrence and relaxation of
concurrence must be sent to:
U.S. E.P.A. Headquarters
Regional Coordinator (e.g., John Foley, region IV)
Case Support Branch (EN-342)
401 M. Street, S.W. - -
Washington, D.C. 20460
Your regional coordinator is responsible for receiving,
tracking, and processing your concurrence requests. Each
request for concurrence will be tracked in a database.
Following the 0CM case support officer’s review, the concurrence
request will be forwarded to the appropriate TLD regional
coordinator.
In the event you have questions concerning these procedures
or the status of a request, you are encouraged to call your 0CM
or TLD regional coordinator, as appropriate. During settlement
negotiations, Regional personnel should also consult with their
appropriate regional coordinators concerning settlement

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—2—
proposals which are not explicitly addressed in the TSCA § 5,
8, 12, & 13 Enforcement Response Policies (ERP).
Another important contact for the Regions is Teresa Little
in the Compliance Branch of 0CM. Teresa is responsible for
servicing the Region’s requests for copies of submitted TSCA
5 & 8 documents and obtaining certified statements. Her mail
code is (EN-342), and her telephone number is (8—382-7835).
Concurrence Procedures and Responsibilities :
1. All enforcement actions and terms of consent agreements
must be submitted to EPA Headquarters, in writing, for
review and concurrence prior to filing these documents with
the Regional Hearing Clerks.
2. The concurrence request (CR) package must include
a. the appropriate concurrence request form,
b. the inspection report.
c. completed IMD certified statements concerning the
Respondent’s TSCA § 5 or 8 reporting status, and (if
applicable) the Inventory Status of suspected “new”
chemical substances.
d. the draft complaint.
3. Failure to supply the items noted above, constitutes an
incomplete package and HQ will request resubmission of the
CR package. If a package is complete, HQ may contact the
Region to discuss additional documentation issues.
4. o Attachment A is a copy of a concurrence request form
for the initiation of an enforcement action.
o Attachment B is a copy of -a concurrence request form
for- concluding an action.
o Attachment C is a request for a certified statement.
Requests for certified statements must be sent to
Teresa Little for processing. She will track your
request and send the completed certified statement to
the requestor. In order to have a completed certified
statement in hand at the time a CR package is being
compiled, HQ suggests that a certified statement
request should be submitted soon after each inspection
which uncovers a potential violation. Depending on
the results of the certified.statement, the Regions
may need to obtain an updated certified statement at
the time the case settles or proceeds to Hearing.

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—3—
5. The Regional Program Office must have the CR package
reviewed and agreed to by Regional counsel prior to its
submission to Headquarters. Further the Regional Program
Office and Regional Counsel are jointly responsible for
ensuring that the alleged violation(s) have been adequately
documented.
6. Headquarters will review the Complaints and terms of the
Settlement Agreements for their adherence to the TSCA § 5
& 8 Enforcement Response Policy, and the filing
requirements of 40 C.F.R. Part 22.14. Headquarters will
respond to each request within 28 calendar days from the
date of receipt. The 28 day clock does not begin until a
complete CR package has been submitted. Resubmission may
be required if the CR packaae is incomplete or incorrect .
7. A Region may not file a Complaint or Consent Agreement with
the Regional Hearing Clerk until Headquarters has
concurred on the filing of the document.
Concurrence Relaxation Process :
Each Region may request relaxation of the concurrence
requirements on an activity-by-activity basis. Once a Region
has successfully issued five TSCA § 5 and five TSCA § 8 civil
administrative complaints, the Region may request the relaxation
of the case issuance concurrence requirement regardless of the
settlement status of the cases. A separate request for
relaxation of the concurrence requirement for case settlement
may be submitted at a later date once any five cases have been
successfully settled.
An action has been successfully issued or completed when a
Region has submitted and filed an action which conformed to the
TSCA § 5, and/or 8, 12, & 13 ERP. Requests to relax
concurrence for case issuance or settlement should be submitted
to the Director of the Compliance Division, 0CM. A sample form
memo to request relaxation for either complaint issuance or
settlement of TSCA § 5 & 8 cases is provided as attachment D.
HQ will process requests for relaxation within 28 calendar days
from our receipt.

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—4—
R EG ION.
( TñM1T DflTM ’P( D
TELEPHONE # / MAIL CODES
Mary McDonnell (OCM/CSB)
Marged Harris (TLD)
Mary McDonnell (OCM/CSB)
Jon Silberinan (TLD)
Sanda Spencer (OCM/CSB)
Jon Jacobs (TLD)
John Foley (OCM/CSB)
David Batson (TLD)
Tony Ellis (OCM/CSB)
Jon Jacobs (TLD)
Rose Burgess (OCM/CSB)
Marged Harris (TLD)
Rose Burgess (OCM/CSB)
Vincent Giordano (TLD)
John Foley (OCM/CSB)
Vincent Giordano (TLD)
John Foley (OCM/CSB)
Jon Silberinan (TLD)
John Foley (OCM/CSB)
David Batson (TLD)
382—4818 / EN—342
475—8696 / LE—134P
382—4818 / EN—342
475—8694 / LE—134P
382—4844 / EN—342
475—8689 / LE—134P
382—4119 / EN—342
475—9501. / LE—134P
382—3705 / EN—342
475—8689 / LE—134P
382—4328 / EN—342
475—8696 / LE—134P
1
2
3
4
5
6
7
8
9
10
382—4328 /
475—8693 /
382—4119 /
475—8693 /
382—4119 /
475—8694 /
382—4119 /
475—9501 /
EN—342
LE—134P
EN— 342
LE—134P
EN—342
LE—l34P
EN—342
LE—134P

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TSCA § 5/8 CASE ISSUANCE: SUbmit t form along With the Draft
Complaint inspection Report, and
Completed Certified Statements
Request f or Concurrence -CaseIssuan
Respondent: (Name & Address)
Regional Contacts Region: 1, 2, 3, 4, s,
name and tel. #) 6, 7, 8, 9, 10
Program Office: Telephone #: 8 -
Counsel: Telephone #: 8 -
Description of Respondent :
Respcndent is a: (chemical manufacturer)
Date of Inspection: SIC code:
Nature of Violation : (Failure to submit a PMN report for 2 chemical
substances, substance not subject to TSCA §5(e) or (f) and was
distributed to customers; and report for the Inventory Update Rule
for 10 chemical substances):
Gravity Based Penalty Calculations :
ount 1: Hazard Assessment, Major, Level 3, 5 days, $75,000
.ount 2: Hazard Assessment, Significant, Level 3, 25 days, $250,000
Count 3: Significant, Level 1, 10 chemicals, one day only $170,000
Total Prooosed Penalty : $495,000
Issues of National or Precedential Significance:
Recommended Action :
Concur ____ Nonconcur _____ Concur ____ Nonconcur _____
Date: _______ Date: _______
Reason for nonconcurrence: Reason for nonconcurrence:
Michael F. Wood, Director Frederick F. Stiehi
Compliance Division Associate Enforcement Counsel
Office of Compliance Monitoring for Pesticides and Toxic Substances
ATT ACHMENT A

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TSCA § 5/8 CONSENT AGREEMENTS:
Request f or ConcurreJlc se Settlenej
despondent: (Name and Address)
Docket No.:
Filed: / /
Regional Contacts Region: 1, 2, 3, 4, 5,
(name and tel. #) 6, 7, 8, 9, 10
Program Office: Telephone #: 8 -
Counsel: Telephone #: 8 -
Gravity—Based Penalty Assessment:
Proposed Penalty Reductions :
Amount Percentage Rationale Documentation
—S
—S
—S
$ % Total Assessed Penalty:
Other Settlement Terms : (include actions taken by the Respondent to
come into compliance)
Recommended Action :
Concur ____ Nonconcur _____ Concur ____ Nonconcur _____
Date: - Date: _______
Reason for nonconcurrence: Reason for nonconcurrence:
Michael F. Wood, Director Frederick F. Stiehi
Compliance Division Associate Enforcement Counsel
Office of Compliance Monitoring for Pesticides and Toxic Substances
ATTACHMENT B

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-S., !RON E - — RO c”:,\ A(E.
_____ r1 ‘•‘ ‘
1ORANDUM
SUBJECT: Request for TSCA § 8 Certified Statement
FROM: Sherry Sterling, Chief
Compliance Branch
Off ice of Compliance Monitoring (EN-342)
TO: Frank Caeser, Chief
Confidential Data Branch
Information Management Division (TS-793)
Attached is a certified statement which will be used as
evidence in a Regional Toxic Substances and Control Act (TSCA)
§ 8 enforcement action. The Facility’s name and address, the
calendar year and chemical for which they were required to
report has been supplied by the Region. The remaining
information is needed from IMD to fully document the violative
acts.
Please send the completed Certified Statement to Teresa
Little, and she will forward it to the appropriate Region.
Attachment
ATTACHMENT C

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CERTIFI ED STATEME!f1
i, Linda A. Travers, am the Director of the Information
Management Division. The Information Management Division of the
office of Toxic Substances is responsible for the receipt of
forms submitted pursuant to Section 8 of the Toxic Substances and
Control Act. I certify to the following facts:
EPA received an EPA Form from the Facility noted
below and assigned this submission the Document Control Number
listed below.
DOCUMENT CONTROL NUMBER:
POSTMARI( DATE:
FACILITY NAME:
FACILITY ADDRESS:
CALENDAR YEAR REPORTED:
CHEMICAL OR
CHEMICAL CATEGORY NAME:
Linda A. Travers, Director
- Information Management Division
Date
ATTACHMENT C, PAGE 2

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MEMORANDUM
SUBJECT:
N:D T rEsENVIRoN 1EN _
=
Relaxation of Concurrence to Issue and/or Conclude
Civil Administrative Actions for violations of Section
5 of the Toxic Substances and Control Act (TSCA)
FROM:
TO:
Region
Director
Division
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring (EN-342)
This memorandum is to request the relaxation of the
requirement to obtain Headquarters concurrence prior to the
issuance (or settlement) of TSCA § 5 civil administrative
actions. Region has successfully issued (or settled) the
following administrative actions:
Complaints Successfully Issued (or Settled)
1. In re:
Docket #:
i led:
TSCA §5 violation(s):
2. In re:
Docket #:
filed:
TSCA §5 violation(s):
3. In re:
Docket #:-
filed:
TSCA §5 violation(s):
4. In re:
Docket #:
filed:
TSCA §5 violation(s):
5. In re:
Docket #:
filed:
TSCA §5 violation(s):
Each of these cases was issued (or settled) in conformance
with the TSCA section 5 Enforcement Response Policy. Copies of
the filed complaints, consent agreements and final orders were
forwarded to our 0CM, Case Support Branch, Regional Liaison in
accordance with standard operating procedures.
If you have any further questions concerning these cases or
Region’s TSCA section 5 compliance program, please contact
at FTS- . I look forward to receiving your favorable
response.
ATTACHMENT D

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V. fo4 A
.&.t I ; .,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
_i.. WASHtNGTON. D C 20460
OP’ICE OF
PESTICIDES ANO TOXIC SUBSTANCES
MEMOPANDUM
SUBJECT: OTS/OCM Joint Inspect ion Program
Fiscal Year 1988, Second Quarter
FROM: A. E. Conroy II, Director
Office of Compliance Monitoring (EN-342
TO: Charles L. Elkins, Director
Office of Toxic Substances (TS—792)
During the past several weeks, staff members from the
Office of Compliance Monitoring (0CM) and the Office of Toxic
Substances (OTS) have discussed the possiblility of establishing
a joint inspection program. The goal of this program is to
provide a routine, practical, and “in—context” avenue for 015
personnel and 0CM inspectors to exchange infortnation. The
means to accomplish this goal is to get OTS personnel out of
the office and into the field with the 0CM inspectors.
My understanding of this program is as follows:
0 0CM will target the inspection, determine what particular
OTS expertise would be most beneficial for the inspection,
lead the inspection, and make the necessary arrangenents for
a smooth and efficient inspectional trip.
o 0CM will then forward the attached memorandum to the appropriate
OTS Division Director for their approval. Once approved,
the memo will be forwarded to OTS Office of Program I1anagement
and Evaluation.
o OTS will provide the funds needed for the OTS employee to
accompany the inspector. OTS will fund one inspection trip
per quarter per Fiscal Year. Therefore, funding for this
program is not required from Divisional or Branch travel
accounts.

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—2-
I am enthusiastic about this program and wish to initiate it
this nonth. If you approve of the program as outlined above please
sign below, return a photocopy of this memo to me, and forward
the attached memorandum to Linda Travers. Otherwise, if you
have any reservations about this proposed program, please call
me to discuss your concerns.
I approve of t e joint inspection program outlined above.
Charles L. Elkins, Director
Offic of Toxic Substances
Attachment
cc: Janet P. Thompson, Director
Office of Program Management & Evaluation
Jan L. Lane, Chief
Management Staff

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I 1 o SP4PF
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460

OFFICE OF
PESTICIDES AND TOXIC SUOSTANCES
MEMORANDUM
SUBJECT: OTS/OCM Joint Inspection Program
Fiscal Year 1988, Second Quarter
FROM: Ken Shiroishi, Director
Compliance Division /
Office of Compliance Monitoring (EN—342)
TO: Linda Travers, Director
Information Management Division
Office of Toxic Substances (TS—793)
The Office of Toxic Substances COTS) and the Office of
Compliance Monitoring (0CM) have recently agreed to sponsor a
joint inspection program. Under this program 0CM will invite,
on a quarterly basis, one OTS employee to accompany an 0CM inspector
on an inspection trip. OTS has agreed to pay the travel expenses
for the OTS employee. The purpose of these special inspections
is to provide a routine, practical, and “in—context” avenue for
OTS personnel and 0CM inspectors to exchange information.
Under this program, the National Enforcement Investigations
Center has requested that Mark Scoville accompany Inspector
William Palmer to Rhode Island to conduct TSCA inspections of
three facilities. The inspection trip will last 5 working days
and will begin in either the last week of January or the first
week of Feburary. The exact dates will be worked out between
Mark Scoville and Bill Palmer.

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—2—
If you approve of this request, please sign below and forward
this memo to Jan Lane (OPME). Jan will then coordinate with Mark
Scoville to prepare his travel authorization.
I approve of the above requested travel for Mark Scoville.
Linda Travers, Director
Information Management Division
cc: Susan Vogt, Deputy Director
Office of Toxic Substances
Janet P• Thompson, Director
Office of Program Management & Evaluation
Dean Hill, Chief
Pesticides & Toxic Substances Branch
National Enforcement Investigations Center
- ! ,; i; ’ ,41.
//
/
/

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i O S7
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
) 4 PROS’
AUG 5 88
orricE or
PESTICIDES AND TOXIC SUSSYANCES
MEMORANDUM
SUBJECT: TSCA §5 Enforcement Response Policy
FROM: Phyllis E.
Acting Director -
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
Attached is the final TSCA §5 Enforcement Response Policy
(ERP) which incorporates the comments received on the February
22, 1988 draft. A summary of the comments and the response to
those comments are also attached. We appreciate the time and
effort spent in reviewing the draft and providing the detailed
comments.
The final ERP has been revised in the following areas:
The policy now addresses all exemption categories found
under 40 CFR Part 723. One major change is that failure
to notify violations are treated differently . depending
on what action the Agency may have taken on the chemical,
i.e., chemicals which otherwise qualify for an exemption,
versus those which go through PMN review without any con—
cerns,and those chemicals which are possible candidates
for a TSCA §5(e) or 5(f) action.
The circumstance levels for failure to notify violations
and commercial use violations have been changed and com-
mercial use violations associated with manufacturing are
no longer treated as a separate violation when the manu-
facturer Is the person who is commercially using the
chemical. Exceptions are made when the number of days of
manufacture and the number of days of processing or com-
mercial use are disproportionate and in lmi inent hazard
Si tuations.
Genetically altered, naturally occurring and low risk
genetically engineered microorganisms are now addressed
in the ERP.

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JUN 8 1989
AMENDED
ISCA SECTION 5
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITOiUNG
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE II. S. ENVIRONMENTAL PROTECTION AGENCY

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—2—
The ERP takes into account whether a substance remains
at the site of manufacture or leaves the site of manu-
facture when determining the circumstances of the yb—
1 ation.
A quick reference chart has been included as an attach-
ment so that a case preparation officer may, once he/she
becomes familiar with the ERP, more quickly determine
the penalty associated with a violation. Please be
advised that extent determinations are not always based
on pounds of chemical substance involved In a violation,
and the quick reference does not Include the full dis-
cussion on extent.
The ERP has been reformatted by placing the Gravity Based
Penalty Matrix after the extent section, so that a
person using the ERP would determine the nature, circum-
stances and extent of a violation and then turn to the
matrix to determine the penalty amount.
The section on Injunctive Actions has been expanded to
clarify when injunctive actions should be considered.
If you have any questions concerning the ERP, please address
them to David Stangel of my staff at 382—7825.
Attachments

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charles Elkins (TS—792)
5 san Vogt (1S—792)
Frederick F. Stiehi (LE-134A)
Mark Green od (LE- 132A)
A. E. Conroy II (EN—342)
Connie Pbsgrove
Ken Shiroishi
Phyllis Flaherty
John J. Neylan III
Jerry Stuths
Maureen Lyden
Ron Carlson
Jake Mackenzie
Western Regional Ca ipliarice Director
I Louis F. Gitto, Director Marvin Rosenstein, Chief
Air Ma gei t Division Pesticides & ‘lbxic &ibstarxes Br
II Barbara Matzger, Director Ernest Regna, thief
aivirorm ital Services Div Pesticides & xic Substaix:es Br
III Ste iai R. Wassersug, Director Larry Miller, thief
Hazar us Waste Manage t Div lbxic & Pesticides Braixth
IV Winston A. &nith, Director Richard DiBose, thief
Air, Pest. & ¶D xics Mangt. Div Pesticides & ¶flicic Substaixes Br
V William H. Sanders III, Dir Phyllis Reed, thief
E ivrorm tal Services Div Pesticides & ¶Lbxic Substaixes Br
VI William B. Hathaway, Dir Robert Mir 2iy, Chief
Air, Pesticides & lbxic Div Pesticides & xic Substaices Br
VII - William A. Sprdtlin, Director Leo Alderman, Chief
Air and 1 xics Division Pesticides & Ibxic SubstarEes Br
VIII Irwin L. Dickstein, Director Alvin Yorke, Chief
Air and ‘Ibxics Division ‘fl xic 9.ibstaixes Braix:h
D( Jeffrey Zelickson, Director Davis Bernstein, thief
¶lbxics and Waste Managei z1 Div Pesticides & xics Brazr.h
X Gary O’Neal, Director Kenneth Feigner, thief
Air and 1 xics Division Pesticides & ‘I xic Substazxes Br
cc: Michael Walker (LE—134P)
Margaret Rostker (‘15—788)

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Response to Comments
Comment
One commenter requested that the definition of Notice of Com-
mencement on page 2 of the ERP be amended to read: “Under 40
CFR 720.102, EPA requires that any person who commences the
manufacture or importation of a new chemical substance for
which that person had previously submitted a PMN, must submit
a notice of commencement of manufacture or import on or no
later than 30 days after the first day of manufacture or
import.”
Response
The definition has been amended as requested.
Comment
One commenter requested that the first factor for cal cul ation
of the gravity based penalty on page 5 be amended to read:
Impact on the Agency’s mandate to evaluate the potential for
human health or environmental effects of a new chemical sub-
stance prior to its production or Import.”
Response
The first factor is amended as requested.
Comment
One commenter requested that on page 7, under Chemical Control
Violations, “Commercial use of an illegally produced substance.”,
be amended to read: “Commercial use of a substance produced
without a PMN or valid exemption.”
R is po n s e
The ERP has been amended throughout to reflect this change.
Comment
A number of persons commented on the fact that, not all exemption
categories In 40 CFR 723 were addressed in the,ERP.
Response
The ERP has been amended to address violations of all the exemp-
tion categories under 40 CER 723.

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—2—
Comment
0-ne person commented that processing of an illegally produced
chemical substance by the company tnat manufactured the sub-
stance is almost an Inevitable part of the manufacturing pro-
cess and that the previous policy of charging two counts when
this occurs Is unfairb Even if the substance never left the
manufacturer’s control, the penalty essentially doubles because
the manufacturer processes the substance. The commenter sug-
gested that the ERP should charge only one count when a man-
ufacturer produces and processes an illegally produced sub-
stance, namely failure to submit a PMN, but raise the cir-
cumstance level when this occurs.
Response
The policy has been amended to charge only one count when a
manufacturer both produces and processes an illegal chemical
substance, but raises the circumstance level one level when
this occurs. However, there are certain exceptions described
in the policy.
Comment
One person commented that while the policy did address genetic-
ally engineered microorganisms, it did not address genetically
altered, naturally occurring or low risk categories of organ—
I sms.
Response
The discussion under extent has been amended to address genet-
ically altered, naturally occurring or low risk categories of
organisms.
Comment
A -number of commenters asked for examples of how the policy
is applied to various fact patterns.
Response
Appendix 1 has been added to provide the user of the policy
with examples of how the policy is to be applied.
Comment
One person commented that the ERP allows environmental benefi-
cial expenses to be deducted from a penalty where the action
was requested but not required by EPA, but gives no similar
allowance to a company that may undertake the same actions
independent of any request by EPA.

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—3—
Response
The ERP has been revised to allow credit pursuant to the TSCA
Penalty Policy to companies that undertake environmentally
beneficial actions.
Comment
A nMmber of persons commented on the fact that the length of
the ERP made it cumbersome to work with when trying to deter-
mine a penalty.
Response
Two revisions have been made to address this comment. First,
the ERP has been reformatted by placing the Gravity Based
Penalty (GBP) Matrix after the Extent section, so that a per-
son using the ERP would determine the nature, circumstances,
and extent of the violation and then turn to the GBP matrix
to determine the penalty amount. Second, a quick reference
chart has been made so that a case preparation officer could
use the quick chart to calculate the penalty, after they be-
come familar with the revised ERP.
Comment
A number of persons had questions concerning the definition
of certain terms used in the ERP and requested that the ERP
contain a definition of these terms.
Response
A definitions section has been added.
Comment
One com’menter remarked that the terms “distribution to others,”
“further processed for commercial use by the company,
“further processed by another firm,” “distributed to consumers,”
and “released uncontrolled into the environment” are used as
the basis for heavier penalties while the rationale for appli-
cation of these terms was unclear.
Response
All the terms used as a basis for assessing heavier penalties
show an increase in potential exposure to the chemical sub-
stance by either workers, the public, or the environment.

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Nh 5
TSCA SECTION 5
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U. S. ENVIRONMENTAL PROTECTION AGENCY

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TABLE OF CONTENTS
INTRODUCTION
Summary of Rules/Requirements
.
. . .
.
1
!IETERMINING THE LEVEL OF ACTION
Admi ni stratlve Clvii Penal ty. . . ..
. . . .
. . . . . .
. . . .
. . . .
....
2
Injunctive Action
3
Criminal Sanctions...... .
....
......
....
....
....
4
ASSESSING A CIVIL ADMINISTRATIVE
PENALTY
SummaryofthePenaityPo l lcy 5
B ackground.......................................... 5
6
CalculationoftheGravityBasedPenalty............ 6
N ature.................... 1 •• I •..... ....... • 7
Circumstances. ......,.,......,.....•,•.....•..•••,.• 8
E xtent................,............................. 13
G ravlty............................................. 15
Per—Day Assessments 15
One—Day Vlolat lons.................................. 15
Imminent Hazard.................... . . 16
Gravity Based Penalty............................... 16
Adjustlngthe Gravity Based Penalty................. 17
Voluntary Dlsciosure................................ 17
.HlstoryofPrlorVlolat lon..........................19
Culpabillty.......... 19
ExplanatlonofthePena ltyPol lcy ... ......20
N ature...,...,...................................... 20
Circumstances....... ........... . 21
Extent.............................................. 22
GravltyoftheV lolatlon.. ...................2
Adjustment Factors.................................. 27

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INTRODUCTION
Section 5(a)(1) of the Toxic Substances Control Act (ISCA)
requires chemical manufacturers and importers to notify EPA
90 days prior to manufacturing or importing a new chemical
substance In the United States. EPA will evaluate the new
chemical substance within 90 days based on the information
supplied by the submitter. If the Agency finds that the infor-
mation supplied is insufficient to permit a reasoned evaluation
of the health or environmental effects of the chemical substance
and that in the absence of such information the manufacture,
distribution, use or disposal of the chemical substance may
pose an unreasonable risk of injury to health or the environ-
ment, or that the chemical substance may be. produced In sub-
stantial amounts which may result in significant human or
environmental exposure, the Agency may Issue an order under
TSCA §5(e) to prohibit or limit the manufacture, distribution,
use or disposal of the chemical substance. TSCA §5(a)(2)
allows the Agency to identify uses of a chemical substance
which EPA has determined are significant new uses and to require
notification of those significant new uses. Certain exemptions
from the full reporting and notification requirements are allowed
under TSCA §5(h). These exemptions may be found at 40 CFR 720.30k
through 720.38 and at 40 CFR Part 723. The major exemptions
from notification are research and development, test marketing,
small quantities (less than 1,000 kg per year), certain polymers
and substances used in instant photographic and peel—apart film
articles.
Failure to comply with the provisions of TSCA §5 is a
violation of TSCA §15 and subject to the remedies found in
TSCA §16.
Summary of TSCA S5 Requirements
Premanufacturing Notification (PMN ) — Under TSCA S5(a)(1) and
40 CFR 720, manufacturers and importers of new chemical
substances are required to submit, 90 days prior to manufac-
turing or importing, a notice of their intention to conduct
such activities as well as any test data in their posession
or control in accordance with 40 CFR Part 720.50.

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—2—
Significant New Use Rules (SNUR ) — Under TSCA §5(a)(2) and
40 CFR 721, EPA specifies by rule the use(s) of chemical
substances which It considers to be significant new uses.
EPA must be notified prior to commencement of any significant
new use.
Notice of Commencement(NOC ) — Under 40 CF 720.102, EPA re-
quires that any person who commences the manufacture or im-
portation of a new chemical substance for which that person
had previously submitted a PMN, must submit a notice of
commencement of manufacture or import on or no later than
30 days after the first day of manufacture or import.
TSCA §5(e) Order — Under TSCA §5(e), If EPA determines that
the information available in support of a PMN is insufficient
to make a reasoned evaluation of the health or environmental
effects of a chemical substance, EPA will issue an order
imposing controls, restrictions or prohibitions on the manu-
facture of the substance in order to address the concerns
of EPA.
TSCA §5(f) Order — Under TSCA §5(f), If EPR finds that the man-
ufacture, Import, processing, distribution, use or disposal of
a chemical substance presents or will present an unreasonaDle
risk of injury to health or the environment before a rule
promulgated under TSCA §6 can protect against such risk, the
Administrator may issue an immediately effective proposed
rule to impose controls or restrictions to protect against
such risk or may Issue an Order to prohibit manufacture,
processing, or distribution in commerce.
TSCA §5(h) ExemptIons — TSCA §5(h) and 40 CFR 720.30 through
720.38 and 40 CFR 723 exempt certain substances and classes
of substances from the full notification and reporting require-
ments of TSCA §5.
DETERMINING THE LEVEL OF ACTION
Enforcement alternatives include civil penalties, injunctive
relief, criminal action or some combination of these actions.
Notices of noncompliance are not appropriate for TSCA §5
violations.
Administrative Civil Penalty
An administrative civil penalty will be the appropriate
response for most violations of these regulations.

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—3—
Concurrence
Civil penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring (0CM) of the Office of
Pesticides and Toxic Substances prior to initiating a civil
admi ni strative penalty for TSCA §5 violations. Reductions for
settlement purposes require the concurrence of 0CM as well and
must be in accordance with the TSCA Penalty Policy and this
Enforcement Response Policy.
Each reduction must be based on the TSCA Penalty Policy
or this policy and justified in the Consent Agreement and
Final Order with specific dollar amounts attrlbuted to each
reduction. Headquarters may relax concurrence requirements
on a Region by Region basis after the Regions have gained
experience with actions under these rules and this policy.
Injunctive Action
In most circumstances, a TSCA §16 admt-nlstratlve action
will provide a complete and timely remedy for TSCA §5 viola-
tions. However, certain cases may present the need for the
types of injunctive relief available under TSCA §17 in addi-
tion to TSCA §16 administrative actions.
Section 17 provides the U.S. District Courts with the juris-
diction to:
— Restrain persons from taking actions prohibited by TSCA §S
5, 6, and 15.
— Compel persons to take actions required by TSCA.
— Direct manufacturers, importers, or processors in violation
of ISCA to: provide notice of the violation or risk of in—
jury to, or repurchase the product from, the consumers of
the violative product.
— Seize any chemical substance manufactured, imported, pro-
cessed, or distributed in commerce tn violation of TSCA.

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-4—
It is Important to note that ISCA §17 does not require
an imminent hazard or recalcitrant respondent as a condition
to its use. However, the Agency believes that the use of
TSCA §17 should be limited to those instances where a civil
penalty action will not mitigate a hazardous situation, is
not likely to result in timely compliance, or where penalties
alone do not provide a complete remedy. Injunctive action is
appropriate in the following examples:
• illegal production/use which presents a hazard to human
health or the environment;
o violatIons of TSCA §5(e) or 5(f) orders, Low Volume Ex-
emptions, or Test Marketing Exemptions which Involve
the failure to use personal protective, equipment or
chemical control measures;
• contumacy, undue delay, or refusal of a violator to
comply with TSCA requirements and regulations; or
o repeat offenders for whom the penalty adjustments for past
history of violations is unlikely to deter future violations.
Criminal Sanctions
Criminal sanctions pursuant to TSCA §16(b) are the most
serious sanctions available for violations of ISCA §5.
Accordingly, criminal sanctions may be sought in situations
that, when measured by the nature of the conduct, the compli-
ance history of the subject(s) and the gravity of the conse-
quences to human health or the environment, reflect the most
serious cases of misconduct.

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—5—
ASSESSING A CIVIL ADMINISTRATIVE PENALTY
Summary of the Penalty Policy
Background
The TSCA Civil Penalty Policy, published in the Federal
Register on September 10, 1980, establIshes a system for deter-
mining penalties in administrative actions brought pursuant to
TSCA §16. Under that system, penalties are determined in two
stages: (1) determination of a “gravitybased penalty’ (GBP),
and (2) adjustments to the gravity based penalty.
To determine the gravity based penalty, the following factors
affecting a violation’s gravity are considered:
• The ‘nature” of the violation.
• The ‘circumstances” of the violation.
• The “extent’ or potential for harm that could result
from a given violation.
These factors are incorporated Into a matrix which allows
determination of the appropriate gravity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made in con-
sideration of these other factors:
• culpability,
• history of such violations,
• ability to pay,
• abflity to continue in business, and
• such other matters as justice may require.

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—6—
The TSCA Civil Penalty Policy system provides a framework
for the development of individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the Gravity Based Penalty Matrix to
assess penalties for specific violations of TSCA §5 and regula-
tions promulgated pursuant to this section.
ppl icability
This policy is immediately applicable and should be
used to calculate penalties for all administrative actions
concerning TSCA §5 Instituted after the date of this policy,
regardless of the date of violation. Pending cases should
be reviewed to determine whether the penalty calculated under
this policy is lower than the penalty in the civil complaint.
If this policy yields a lower penalty, an amendment to the
complaint should be made to substitute the lower penalty.
This policy should not be used to raise penalties in
existing actions. No case should be settled for an amount
higher than the penalty which this policy would yield.
Calculation of the Gravity Based Penalty
Penalties for TSCA §5 violatIons vary depending on the
nature, extent, circumstances and whether penalties are to be
calculated as one—day assessments or per—day assessments. In
establishing each of these, the Agency considered the following
factors in a comparative manner:
• Potential for and/or the relative degree of harm to
human health or the environment caused by failure to
comply. This directly relates to the impact on the
Agency’s mandate to evaluate and control the poten-
tial for human health r environmental effects of a
new chemical substanceA prior to its production or
import.
o Potential exposure of the public or the environment
to an unregulated new chemical substance.
o Impact on the validity of the Inventory, which the
statute mandates the Administrator to keep current.
o Deterrent effect the penalty would have or the like-
lihood that the penalty will deter future violations.

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—7—
Nature
The nature of the TSCA violation depends on whether the
violation relates to chemical control, control—associated data—
gathering, or hazard assessment. It Is important to make this
determination first. Determining the nature of the violation
is necessary prior to using the extent matrix. The following
list places the violation types in their respective categories.
1) Chemical Control Violations
o Noncompliance with TSCA §5(e) or 5(f) orders,
rules, or injunctions and significant new use rules
(those aspects dealing with the actual control of
the substance, i.e., production, commercial use,
disposal, production restr1ctiot s, etc.).
o Noncompliance with research and development exemption
restrictions (noncompliance with the adequate warning
and supervision of a technically qualified Individual
requirement).
• Noncompliance with test marketing exemption
restrictions (those aspects dealing with the
actual control of the substance).
• Noncompliance with exemption restrictions under
40 CFR 723 (those aspects dealing with the actual
control of the substance).
2) Control—Associated Data-Gathering Violations
• Noncompliance with the recordkeeplng provisions of
TSCA §5 orders, rules, or Injunctions.
• Noncompliance with the recordkeeping provisions of
exemption restrictions under 40 CFR 723.
o Noncompliance with the recordkeeplng provisions of
the research and development and test marketing
exemption restrictions.
3) Hazard Assessment Violations
f,im
• All failures to notify EPA when such notification J ,,
Is required by law. / / “ ‘),
(_ 5 4 / 1 1M 5
• Withholding material information from or submitting
false or misleading information in aTSCA §5 notice
or exemption request.
• Commercial use of a substance produce i without a
PNN or valid exemption.

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—8—
o Noncompliance with the reporting provisions of
ISCA §5(e) or 5(f) orders, rules, or injunctions.
o Any violation not listed previously.
Circumstances
Once the nature of the violation has been determined, the
second step in calculating the penalty is determining the cir-
cumstances of the violation. The circumstances determination
Is based upon the probability that harm could have taken
place — an a priori potential for harm to the environment or
the Agency’s decisioninaking or ability to regulate, i.e.,
potential exposure to an unregulated chemical substance or
harm to the integrity of the Inventory. Any after the fact
determi nation that harm did or did not take place Is irrele-
vant to the initial circumstance level determlnatlon. The
gravity based penalty matrix provides for six circumstance
levels. Levels one and two represent the Agency’s determina-
tion of circumstances where there exists a high probability
of harm. Levels five and six represent circumstances of low
probability of harm and levels three and four fall between
these high and low probabilities.
The circumstance level of a violation9s designated in
the following manner.. Please note that many of the levels
refer to a PMN being subject to a TSCA §5(e) or 5(f) action.
Please refer to page 22 for a further explanation of when a
substance is subject to a TSCA §5(e) or 5(f) action.
Failure to Notify
Failure to submit a PMN not subject to a TSCA §5(e) or 5(f)
order or exemption when the substance was not distributed
to others or further processed for commercial use by the
company lsT level 4 vIolation, per—day.
Failure, to submit a PMN not subject to a TSCA §5(e) or 5(f)
or’der or exemption when the substance was distributed to
others or further processed for commercial use by the com-
pany Is a level 3 vIolation, per—day.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action but was not
either distributed to others or further processed for
commercial use by the companyTs a level 2 vIolation, per—day.
Failure to submit a PMN when the substance Is or would have
been the subject of a TSCA §5(e) or 5(f) action and the
substance was either distributed to others or fui9 ’Rer
processed by the company is a level 1 violation, per—day.

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—9- Aaien 1ed
Failure to submit a P;4N for a chemical substance which would
neet all requirements for a polyner exemption under 40 CFR
723.250, except that the company did not file for an exemption,
will be assessed as a level violation, per— ay.
Failure to submit a PMN for a chemical substance which would
meet all requirements for a polymer exemption under 40 CF
723.250, except that the company did not file for an exemption
and the substance was further processed for commercial use,
distributed to consumers, or released uncontrolled into the
environment will e assessed as a level 4 violation, per—day.
Failure to submit a Notice of Commencement is a level 3
violation, one—day.
Failure to submit a timely Notice of Commencement (early or
late submission, up to 30 days prior to manufacture or 30 to
60 days after manufacture) is a level 6 violation, one—day.
Failure to submit a timely Notice of Commencement (early or
late submission, more than 30 days prior to manufacture or
more than 60 days after manufacture) is a level 4 vIolation,
one—day.
Withholding information or submitting false or misleading
information with regard to ilS1’ nificant New Use Notice,’ ”
or exemption request is a level 1 violation, per—day. __J
Submission of a false Notice of Com’ encement is a level 1
violation, one—day.
Noncompliance with TSCA 5(e) or 5(f) Orders, Rules or
injunctions ana signiticant New use Rules
Violation of on—site restrictions is a level 2 violation,
per—day.
Violation of off—site restrictions where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment is a level 1
Violation, per—day.
Failure to submit a Significant New Use Notice when the sub-
stance was distributed is a level 2 violation, per—day.
Failure to submit a Significant New Use Notice when the sub-
stance was distributed to consumers is a level 1 violation,
per—day.
Violation of production ban or restriction is a level .1
violation, per—day.
Failure to generate reports as required is a level 2 violation,
per—day.

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—10—
Failure to generate reports as required, where the substance
was either processed by another firm or distributed to
consumers or released uncontrolled into the environment is
a level 1 Tolation, per—day.
Late submission of required reports where the substance was
not distributed or processed is a level 4 violatIon, per—day.
Late submission of required reports where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment is a level 3
Vfolation, per-day.
Withholding information or submitting false or misleading
Information is a level 1 vIolation, per—day.
Violation of the recordkeeplng provisions where the firm
produces the missing records within 5 days of a written EPA
request is a level 4 vIolation, one—day.
Violation of the recordkeeping provisions where the firm
cannot produce the missing records within 5 days of an EPA
request is a level 3 violation, one—day except as specified
on page 26 of the policy.
Commercial Use of a Substance Produced Without a PMN or Valid
Exemption
Commercial use violations will be charged in two circumstances:
1. Where a company processes or uses a chemical substance which
It did not manufacture and it has reason to know is not on
the Inventory.
2. Where a chemical substance was manufactured or imported the-
gally on just a few occasions and processed over a long per—
- iod of time, the substance would have been subject to a TSCA
§5(e) or 5(f) order, and the activity could have caused
substantial endangerment to health or the environment.
Commercial use violations will be assessed as follows:
Violation where the substance was not processed by or dis-
tributed to others after recei tbithe user is a level 4
violation, per—day.
Violation where the substance was further processed by or
distributed to others is a level 3 violation, per—day.
Violation where the substance is or would have been the subject
of a ISCA §5(e) or 5(f) action but was not processed by or
distributed to others is a level 2 violation, per—day.

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—11—
Violation where the substance is or would have been the subject
of a TSCA §5(e) or 5(f) action and was either processed by
othe rs or released uncontrolled into the environment is a
level 1 violatIon, per—day.
In cases involving imminent hazard the Agency reserves the right
to charge a manufacturer with both failure to submit a PMN and
illegal commercial use of the substance.
Noncompliance with Test Marketing Exemption Restrictions
Overproduction by 10% or less is a level 3 violation, per—day.
Overproduction of more than 10% would be charged as a failure
to submit a PMN.
Violation of exposure related) on—site restrictions is a
level 2 vIolation, per—day.
Violation of recordkeeplng provisions Is a level 4 violation)
one—day except as specified on page 26 of the policy.
Violations of the off—site control provisions of a IME where
the substance was either distributed to consumers or was
released uncontrolled Into the environment is a level 1
violation, per—day.
Noncompliance with Research and Development Exemption Restrictions
Violations regarding the labeling of the R&D substance where
the substance was further processed by another firm is a
level 2 violation, per—day.
Violations regarding the labeling of the R&D substance where
the substance was either distributed to consumers or was / ç\ ,c
released uncontrolled into the environment Is a level 1 “
violation, per—day.
V
Please note that any violation of an R&D exemptionother
than failure to adequately label the R&D substance, would
cause the charge to be a failure to submit a PMN.
Noncompliance with Low Volume Exemption Restrictions
Violations regarding the notification of custom rs of the re-
strictions on use of the substance is a level 2 violation,
per—day.
Violations regarding the failure to notify EPA of any changes
in site or use of the exempted chemical is a level 2 viola-
tion, per—day.

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—12—
Violations of the recordkeeping provisions of the low volume
exemption is a level 3 violation, one—day except as specified
on page 26 of the policy.
Viol-ations of the 1,000 kg. production limit would be viewed
as a failure to submit a PMN.
Violations regarding the failure to maintain required exposure
controls is a level 2.violation, per—day.
Noncompliance with the Instant Photographic and Peel—Apart
Film Article Exemption Restrictions
Failure to limit manufacturing and processing to site(s)
listed in the exemption application is a level 5 violation,
per—day.
Distribution in commerce or use of a peel—apart film article
containing a new chemical substance prior to its being cleared
through the PMN process would be considered a failure to
submit a PMN and subject to the penalties thereunder.
Failure to follow the conditions of manufacture for instant
photographic or peel—apart film articles where the substance
would not have been subject to a TSCA S5(e) or 5(f) order is
a level 2 violation, per—day.
Failure to follow the conditions of manufacture for instant
photographic or peel—apart film articles where the substance
would have been subject to a TSCA §5(e) or 5(f) order is a
level 1 violation, per—day.
Violation of the recordkeeping provisions of this exemption
Is a level 3 violation, one—day except as specified on page
26 of the policy.
Noncompliance with Polymer Exemption Restrictions
Violations regarding the submission of test data with the
exemption application is a level 1 violation, per—day.
Violations of the recordkeeping provisions of the polymer
exemption Is a level 4 violation, one—day.
All other violations of the polymer exemption would be
charged as a failure to submit a PFIN.
Production
Production of a chemical substance not subject to a TSCA §5(e)
or 5(f) or ter or exemption after submission of a PMN but
prior to the expiration of the PMN review period is a level
3 violation, per—day.

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—13—
Production of a chemical substance after submission of a PMN
but prior to the expiration of the PMN review period when
the substance becomes or would have been the subject of a
TSCA §5(e) or 5(f) actIon or the substance was distributed to
consumers is a level 2 vio’lition, per—day.
Production of a chemical substance prior to the expiration of
the PMN review period when the substance becomes or would have
been the subject of a TSCA §5(e) or 5(f) actIon and the substance
was distributed to consumers is a level 1 vlolatföi, per—day.
Other Violations
Any other violation not listed above isa level 4 violation,
per—day. -
Extent
The third step in selecting the base penalty for a spe-
cific violation from the matrix is to determine the violation’s
position on the extent axis. Extent is based on the amount of
substance involved In the violation and the nature of the
violation. The following table is to be used to determine
the extent of a violation.
EXTENT MATRIX*
Nature
Extent Level
A
B
C
Major
Significant
Minor
Chemical
>2,500 lbs
‘250 lbs to 2,500
lbs
>0
to 250 lbs
Control
>1,134 kg
>113.4 kg to 1,134
kg
>0
to 113.4 kg
Control-
>10,000 lbs
>1,000 lbs to 10,000
lbs
>0
to 1,000 lbs
Associated
>4,536 kg
>453.6 kg to 4,536
kg
>0
to 453.6 kg
Data—
Gathering
Hazard
>7,500 lbs
>750 lbs to 7,500
lbs
>0
to 750 lbs
Assessment
‘3,402 kg
>340.2 kg to 3,402kg
O
to 340.2 kg
* Note exceptions listed on page 14 and 15 under Notes for
determining extent.

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—14—
Notes for determining extent
1) Production records will generally serve as the extent
basis in the following violation categories:
o All fail ures to notify EPA when such noti fication
is required by law.
Noncompliance with TSCA §5(e) or 5(f) orders,
rules, or injunctions.
• N9ncompliance with exemptions under 40 CFR Parts
720 and 723.
Where there are no production records, the penalty will
be assessed at the major extent and may be adjusted If
the firm provides data which can be used to determine
the extent. If the underlying violative conduct does
not relate to production, another more appropriate
basis should be employed to determine extent. If, for
example, the violator disposes of 5,000 pounds of the
substance in violation of the terms of a TSCA §5(e)
order, then the amount of the substance disposed,
as evidenced in disposal records, .,is the basis of
the penalty.
2) The basis of extent in a commercial use violation will
be the amount of Illegally produced substance processed
or used by the violator on a given day.
3) If the records specified above are unavailable, the
penalty is to be assessed from those records that are
available if possible or at the major extent level.
4) ViolatIons for withholding information, submitting false
or misleading information, or failure to submit reports
required by a TSCA §5(e) or 5(f) order, rule or injunc-
tion do not lend themselves to extent determinations
based on production amounts. For the purposes of de-
termining per—day penalties under this ERP, if the
the study which is the subject of the violation in-
volved human monitoring data, the extent is major.
If the study which is the subject of the violation
Involved animal laboratory data, the extent is
significant. If the study involved physical or
chemical properties or environmental fate data, the
extent is minor. This is consistent with the TSCA
§ 8, 12, and 13 Enforcement Response Policy.
5) Violations involving genetically engineered microor-
ganisms do not lend themselves to exten.t determinations
based on the matrix, due to the extremely small amounts
involved. These microorganisms may have the ability to
reproduce, creating a larger environmental hazard.

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—15—
Therefore, any violation involving a genetically
engineered microorganism will be considered major
In extent. Likewise, violations involving any genetic-
ally altered or naturally occurring organisms subject
to a SNUR or TSCA §5(e) order will be considered major
in extent. In the event the Agency Identifies low—risk
categories of organisms, violations involving low—risk
organisms will be considered significant.
6) All Notice of Commencement violations will be considered
major in extent.
Gravity
Gravity, as used in this ERP, is dependent upon the nature,
extent and circumstances of the violation.
Per—Day Assessments
Where per—day assessments are provided for in the Circum-
stances Level section, the base penalty Is calculated for the
first occurrence of a violative activity and assessed for each day
of subsequent occurrence. For example, a manufacturer or importer
Is responsible for notifying EPA prior to j roduct1on or Import-
ation of a new chemical substance. Each day of production or
Importation of a new chemical substance In violation of the
4’ notIfication requirements of TSCA §5 constitutes a new viola-
tion. A day of violation Is counted for each day a chemical
substance Is produced regardless of the number of batches pro-
duced on a given day. The total amount produced on a given day
would be used when determining extent. If production of a chemi-
cal substance takes place over a number of days before the
manufacturing process is complete, production occurs only when
the manufacturing process has been completed. Likewise, a manu-
facturer or Importer subject to an order, rule or injunction
under TSCA 55 whIch directs him to dispose of the substance or
wastes ‘In a particular manner, Is in violation for each day dis—
posal occurred contrary to the requirements of the order, rule or
injunction. Illegal commercial use violations are assessed under
the same principles. Commercial use violations, however, are
based on the amount of Illegally produced chemical substance used.
( Per—day penalties assessed on a daily basis (I.e., calendar
f days vs. days of actual production) are generally reserved for
j violations of the data—gathering provisions of,TSCA §5 where
J the Agency needs the data to assess the risks presented by a
chemical substance, or situations involving imminent hazard.
One—Day Violations
Violations of the recordkeeplng provisions bf TSCA §5 are
assessed on a one—time basis only except where compliance cannot
be determined or noncompliance was intentional. See pages 22
and 26 for a further discussion of these issues.

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—16—
Imminent Hazard
Upon review of the facts surrounding a violation, the
Agency may make a finding that continued production, sale and
distribution of a substance may present an imminent hazard to
health and the environment. In the event of such a finding,
the Agency may take steps to halt further production, sale and
distribution of the product as well as assess the maximum pen-
alty of $25,000 per day for each calendar day the exposure from
manufacturing and/or commercial use occurred. Thus, if the
Agency determined that exposure to a substance found to be an
imminent hazard occurred for 90 days, the penalty would be
90 X $25,000 or $2,250,000.
Gravity Based Penalty -
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent of each violation, is to be determined
by using the following matrix:
Whether a penalty is to be assessed as a on e—day assessment
r as a continuing violation on a per—day basis Is addressed in
the Circumstances section and on page 15.
)
GRAVITY
BASED PENALTY
MATRIX
Circumstances
Extent
.
A
B
C
Major
Significant
Minor
Levels
1
High Range
$25,000
$17,000
.‘.‘
$ 5 , 00 Q
—
2
$20,000
$13,000
$3,000
3
$15,000
$10,000
$1,500
Mid Range
4
$10,000
$ 6,000
$1,000
.5
$ 5,000
$ 3,000
$500
Low Range
6
$ 2,000
$ 1,300
$200

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—17—
Adjusting the Gravity Based Penalty
Follow the adjustment factor application instructions as
presented in the general TSCA penalty policy document, “TSCA
Civil Penalty System of September 10, 1980 at pages 9—16.
Adjustment factors specific to this policy are discussed
bel ow.
Other Factors As Justice May Require
Voluntary Disclosure
Penalty amounts for violations of TSCk §5 will be reduced
when the violations are voluntarily disclosed by the company.
For TSCA §5 violations the penalty reductions for voluntary
disclosure are as follows.
Voluntary disclosure . . . . . . . . . . . . ......... .25%
Immediate disclosure within
30 days of discovery.... 1•I ... .. .25%
Takes all steps reasonably -
expected ..........................up to 15%
Total......up to 65%
The reduction for voluntary disclosure and immediate disclosure
may be made prior to issuing the Civil Complaint. The Civil
Complaint should state the original penalty and the reduced
penalty and the reason for the reduction.
The Agency wants to encourage voluntary disclosures for
TSCA §5 violations. In order to do this, an automatic penalty
reduction may be made. To be eligible, a firm must make the
disclosure prior to being notified of a pending inspection
and the disclosure cannot be one that Is required by TSCA
§8(e) or that Is made after EPA has received Information
relating to the alleged violation. Voluntary disclosure of
a violation will result in a 25% reduction of the penalty.
In some cases, companies have delayed 9—12 months in re-
porting a violation. An additional 25% penalty reduction may
be given to those companies which report the potential violation
to EPA within 30 days of having reason to believe that they may
be In violation. This reduction is also applicable to firms
which have changed ownership.
If a company realizes it cannot find a chemical which It
is manufacturing on the non—CBI Inventory, and for which it did
not submit a PMN, It has reason to believe that it may be in
violation. The time limit begins the moment the company has
reason to believe that the chemical may not be on the Inventory,
not after EPA has confirmed the Inventory status. of the chemical.

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-18-
Environmentally beneficial expenditures above and beyond
those specifically required under TSCA are allowable penalty
reductions at the Agency’s discretion. Generally, environ-
mentally beneficial expenditures may be deducted from the
penalty at the Agency’s discretion In accordance with the
TSCA Civil Penalty Policy for recall costs and special dis-
posal costs, if such action Is requested by EPA or undertaken
by the company independently, but not required by TSCA, a
regulation, order, or TSCA SS7 or 17 and such action is
conducted in a manner satisfactory to EPA.
As an alternative to the deduction of costs for environ-
mentally beneficial expenditures, a penalty reduction of up to
15% may be made for voluntarily disclosed violations at the
Agency’s discretion if the company takes all steps reasonably
expected/requested by EPA to mitigate the violation. This
Includes timely submission of Information necessary for EPA
to assess a violation. Timely submission means within 30 days
or a time period agreed upon by EPA and the company. This
reduction is not In addition to reductions for environmental
expenditures above and beyond that required by the law, but
is an alternative. This reduction of up to 15% is only appli-
cable to companies which have voluntarily disclosed the
violation and may be taken In addition to the Attitude of the
Violator adjustment found in the TSCA Civil Penalty Policy.
If the steps expected/requested by EPA have not been taken
at the time of settlement, this section does not apply.
Future activities may be addressed in accordance with the
Settlement with Conditions Policy.
In some cases, mitigation may not be possible. For example,
if the product was distributed In commerce and has already been
used, there may be nothing the company can do to rectify the
situation. In these cases, no reduction will be given under
this heading. In other cases, If no steps are expected because
cessation of the violative action Is sufficient, I.e., the
chemical clears the PMN process and OTS makes a finding that
no corrective actions are necessary, EPA may still give the
added 15% reduction for companies that have voluntarily
disclosed the violation, provided the penalty exceeds any
economic benefit gained by the company.
An example of a situation in which EPA may give the addi-
tional 15% reductIon Is one in which a company manufactures
a chemical not on the Inventory and does not file a PMPI. The
company notifies EPA of the possible violation,, immediately
ceases all manufacture, processing, and distrib tlon until
it files a PMN and the chemical clears the review period
without being a candidate for a TSCA 55(e) or 5(f) actIon.

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—19—
Economic Benefit
In no cases shall reductions be given if the reduced
penalty does not exceed the economic benefit gained from non-
compliance. EPA should require the company to present infor-
mation concerni’ g economic benefits gained from the violative
action prior to the reduction of the penalty except for the
25%/50% off for voluntary disclosure. In all cases, EPA wishes
to encourage voluntary disclosure.
Attitude
The existing adjustment provision for the Attitude of
the Violator In the TSCA Civil Penalty Policy (Septemeber 10,
1980) may also be applied to adjust the penalty by up to 15%.
Please note that this adjustment may decrease or increase the
penalty by 15%. This adjustment applies equally to companies
that voluntarily disclosed violations and those that did not.
A company would generally qualify for a downward adjustment
if it Immediately halts the violative activity, takes steps
to rectify the situation and there is no finding of culpa-
bility. However, such a reduction is at the discretion of
EPA. -
History of Prior Violation
The Agency will disregard the firm’s prior history of
violations in calculating the penalty for a self—disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as indi-
cated in the TSCA Civil Penalty Policy, even if the prior
history results from a violation which was voluntarily
disclosed.
Culpability
- The culpability of a violator may be taken into account
when a violator does not have control over the violation
charged. An example would be a company importing a chemical
substance from a foreign manufacturer where the foreign manu-
facturer falsely certifies that the substance is on the TSCA
Inventory and the company importing the substance only knows
the trade name of the substance. The importing company must
be able to provide a copy of the written false. certification
and show that they were unable to ascertain the Identity of
the substance by any other means. The Agency can reduce the
penalty by up to 25% In such situations. In the event of
further violations of this type, history of prior violation
would not be considered when determining the penalty.

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-20-
Explanation of the Penalty Policy
Nature
The nature of a TSCA §5 violation depends on whether the
violation deals with chemical control, control—associated
data—gathering, or hazard assessment.
1. Chemical control regulations are aimed at minimizing
the risk presented by a chemical substance by
placing constraints on how the substance is handled.
Section 5(a)(2) authorizes the Administrator to mak
a determination that use of a hemlca1 Is a signifi-
cant new use and require the manufacturer or importer
to notify EPA prior to Initiating such a use.
Sections 5(e) and 5(f) authorize a wide variety of
WiiiiTcal control requirements from bel Jig _ restrjç•
¶Töii to manufacturing bans. Section 5(h)(1) author—
Izes the Administrator to Impose restrictions upon
the manufacture or processing of a test marketed
substance. Violations of those restrictions that
place constraints on how a substan_ce is handled fall
into this category. Section 5(h)(3) obligates a
firm producing a substance under a research and de-
velopment exemption to give adequate warning to
employees if that substance Is dangerous. This is
also a constraint on a substance’s handling and is
included in this category.
2. Control—associated data—gathering requirements are
the recordkeeping and/or reporting requirements
associated with a chemical control regulation.
These requirements enable the Agency to evaluate the
effectiveness of the regulation and to monitor
compliance. Some requirements in TSCA §5(e) and 5(f)
orders, rules, or injunctions would fall into this
category (i.e., a section 5(e) order that requires the
manufacturer to keep records of all purchases of the
regulated substance). Some test marketing exemption
restrictions would also fall into this category as
section 5(h)(1)(B) authorizes the Administrator to
Impose, among other things, recordkeeping and/or
reporting requirements.
3. Hazard assessment requirements are used to develop
and gather information necessary to we igh the risks
and benefits presented by particular chemical sub-
stances and to impose chemical control requirements
when appropriate. This category includes violations
for failure to notify, withholding information from
EPA or submission of false or misleading information.

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—21—
Circumstances
Circumstances are used in the penalty policy to determine
the probability of potential harm. In other words, a variety
of facts surrounding the violation as it occurred are examined
to determine whether the circumstances of the violation are
such that there is a high, medium, or low potential for harm.
To calculate the penalty first use the nature determination
list to select the appropriate nature category and then
select the appropriate circumstance.
Application of the Circumstances Factor to Section 5
1) Chemical control . Chemical control violations in-
clude noncompliance with TSCA §5(s) or 5(f) actions,
failure to submit a significant new use notice,
noncompliance with a research and development exemp-
tion restriction on adequate warning, noncompliance
with test marketing exemption restrictions on the
actual control of the substance, improper commercial
use of a substance produced in violation of a TSCA
§5(e) or 5(f) order, or noncompliance with any ex-
emption restriction on the use of_a substance found
under 40 CFR Part 723. For these violations, the
initial circumstance level is based on the severity
of the violation. Circumstance evaluations are
adjusted by the degree of potential environmental
exposure and potential risk posed by the chemical.
2) Control—assocl ated data—gatheri ng . Control—associ—
ited data—gathering violations include noncompliance
with the recordkeeplng provisions of TSCA §5(e) or
5(f) actIons and exemption restrictions under 40 CFR
Parts 720 and 723. For these violations the circum-
stances are dependent on the extent to which the
Agency’s ability to monitor and/or evaluate the
risks posed by the substance or the company’s com-
pliance with the substantive legal requirements Is
impaired.
3) Hazard assessment . Hazard assessment violations
Include failure to submit a premanufacturing noti-
fication and associated commercial use, failure to
submit a notice of commencement, withholding infor-
mation, submitting false or misleading information,
and noncompliance with the reporting provisions of
TSCA §5(e) or 5(f) actions.

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—22—
When determining whether a PMN is subject to a TSCA §5(e)
or 5(f) action, there are Instances where rather than Imposing
controls under a TSCA §5(e) order with testing triggered at a
particular production volume or time, EPA requires testing
upfront before manufacture may commence. If the company
refused to either do the testing or withdraw the PMN , EPA
would then unilaterally issue an “adversarial” ISCA §5(e)
order prohibiting any manufacture. This type of case would
be treated as a TSCA §5(e) or 5(f) action and subject to
higher penalties.
When determining the circumstance level for recordkeeping
violations when EPA has requested the missing records, EPA
must be able to determine compliance from the records which
are provided or the charge would be considered failure to
produce the missing records. Where records are necessary to
determine compliance with a requirement of a TSCA §5 action,
rule, or injunction and the records cannot be produced, EPA
reserves the right to charge per day penalties.
PMN violations involving chemical substances which meet
all requirements for a polymer exemption under 40 CFR 723.250,
except the company did not file for an exemption, will be
assessed at a level 5 circumstance. EPA has determined that
chemicals which qualify for these exemptions are of less
concern as a hazard.
Extent
Extent is used to take into consideration the degree,
range, or scope of the violation. The Extent Matrix (pg. 13)
provides for three levels of extent: Major, Significant, and
Minor. The three levels are generally based upon the amount
of substance involved in the violative conduct.
Production records will generally serve as the penalty
ba-sis In the following violation categories:
o All failures to notify when such notification is
required by law.
o Noncompliance with TSCA §5(e) or 5(f) orders, rules,
or Injunctions and significant new use rules (except
reporting violations).
1 ° Noncompliance with test marketing or research and
development exemption restrictions.
o Noncompliance with exemption restrictions under 40
CFR Parts 720 and 723.

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—23—
If a chemical substance is manufactured for commercial
purp.oses as part of a chemical mixture, the amount of the
chemical substance from which the mixture is made is used to
calculate the penalty. If a chemical mixture made from a
chemical substance Is Incorporated into an article, the
penalty is calculated from the amount of the chemical sub-
stance used to manufacture the chemical mixture. If the
amount of chemical substance used to manufacture the chemical
mixture is unknown, the amount of chemical mixture will be
used to determine extent. If a portion of a batch containing
an illegally manufactured chemical substance is sold/distri-
buted for commercial purposes, the entire batch Is considered
to be manufactured for commercial purpo es and the amount
of the chemical substance used to manufacture the entire
batch is used to calculate the penalty. Likewise, if one
batch of an illegally manufactured chemical substance is
sold/distributed for commercial purposes, all other batches
of the chemical substance are considered to be manufactured
for commercial purposes.
If a firm disposes of a substance in violation of a test
marketing restriction or a section 5(e) Injunction, then the
amount ii legally disposed is the basis of the penalty.
TToiations involving genetically altered, naturally oc-
curring or genetically engineered microorganisms will all be
placed in the major extent category due to the Agency’s
general level of concern over the potential for harm from
unregulated environmental release. In the event the Agency
Identifies low risk categories of organisms, violations in-
volving low risk organisms will be placed In the significant
extent level.
It should be noted that if those records specified above
are unavailable, the penalty should be assessed on those
records that are available or where there are no records,
asiume the violation is major In extent.
Determining extent for violations involving withholding
I n formation, s.ubjijt.t_th gfaiieor ml s] _ e&ding.Jn.fp rmat ion, or
failure to generate reports as required by a TSCAt5(e) or 5(f)
action requires different criteria. Th s..e_v.to.1aLt_i.o.ns._a-r-e
a .!Jsed _ for _ e.ach..A yt e violation occurred beginning fr ip
the day the information was submitted or should h&v..e.....be..e1L .
submitted. While the amount ri substance produced has
i ron the potential exposure of the public or environ-
ment to that substance, the harm is caused by the failure to
submit the data or submit true and complete data. Consistent
with the ISCA §S8 , 12 and 13 Enforcement Response Policy,
extent is determined by the type of data involved in the
violation. If the subject study involves laboratory animal
data, the extent is determined to be significant. If the
subject study involves physical/chemical properties or
environmental fate data, the extent level is minor.

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—24—
The tree levels of extent (major, significant and minor)
are based on the potential for harm to health or the environ-
ment. As stated previously, chemical control violations are
considered the most serious due to the fact that risks have
largely been identified and steps have been taken to mitigate
those risks. Thus, the amount of production/disposal necessary
to place a violation into the major and significant categories
is substantially less than the amounts which place a violation
into those same categories for hazard assessment violations or
control—associated data—gathering violations. Hazard assessment
violations Impair the Agency’s ability to determine the risks
presented by a particular new chemical substance and impose
control requirements. Because the Agency has no way of knowing
whether the substance presents a risk to health or the envi-
ronment, hazard assessment violations re placed between chem-
ical control violations and control—associated data—gathering
violations in terms of the amount of substance necessary to
place a violation in the various extent levels. Control—asso-
ciated data—gathering violations impair the Agency’s mission
to mitgate threats to health and and the environment the
least. These violations involve the recordkeeping provisions
of a TSCA §5 action. Nonetheless, they are Important for
the Agency to assure compliance.
Application of the Extent Factor to Section 5
1) Chemical control violations . The Agency will have
either knowledge or concerns that the substance may
be harmful. Thus the potential for harm is greatest
in this category. An amount of a substance that
is considered minor or significant in the two other
categories may be considered major here. A minor
designation covers amounts from 0 to 250 lbs. (0 to
113.4 kg.); a significant designation covers amounts
greater than 250 lbs. to 2,500 lbs. (113.4 kg. to
1,134 kg.); the major designation is assigned to
amounts greater than 2,500 lbs. (1,134 kg.).
2) Control—associated data—gathering . Since
production, distribution, etc. is always allowed,
the penalties escalate more slowly than for the
chemical control category violations: minor is 0 to
1,00G lbs. (0 to 453.6 kg.); significant is greater
than 1,000 lbs. to 10,000 lbs. (453.6 kg. to 4.536
kg.); major is greater than 10,000 lbs. (4,536 kg.).
3) Hazard assessment . in this category, the Agency can
neither assume that the substance is harmless nor
harmful. The violations, however, are more serious
than those in the control-associated data-gathering
category: minor is 0 to 750 lbs. (0 to 340.2 kg.);
significant is greater than 750 lbs. to 7,500 lbs.
(340.2 kg. to 3,402 kg.); and major is greater
than 7,500 lbs. (3,402 kg.).

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—25—
Gravity of the Violation
Gravity refers to the overall seriousness of the violation.
As used in this penalty system, gravity Is a dependent variable
(I.e., the evaluation of nature, extent, and circumstances will
yield a dollar figure in the matrix that Is the gravity based
penalty).
Imminent Hazard
Imminent hazard violations require the Agency to make a
finding that a particular violative substance presents an im-
minent hazard to health or the environment. Penalties for
violations involving imminent hazards are assessed for each
day the violation continues at the maximum penalty allowable
when a company manufactures and uses the hazardous chemical.
In these cases separate charges, one for manufacturing and
one for commercial use may be assessed.
Per—Day Penalties or One—Day Assessments
TSCA 516(a)(1) provides not only that civil penalties may
be assessed up to $25,000 but that each day a violation con-
tinues Is a separate violation for which peiialtles may be
assessed. For the purposes of this ERP, per—day penalties will
be assessed for each day a violation of TSCA 55 occurs. If,
for example, a firm Is charged with the illegal manufacture of a
chemical substance, each separate day of manufacture constitutes
a violation regardless of the number of batches produced during
that day. The total amount produced In a day would be used as
the basis for the extent of the violation if a company has more
than one facility illegally producing a substance on a given
day. Likewise, If a firm illegally disposed of a substance, the
penalty is based on the number of days the disposal occurred
regardless of the number of shipments for disposal on a given
day. The total amount of a substance produced or disposed of
on a given day Is used when determining extent. Where the
ma-nufacture or processing of a substance takes several days
to complete, the penalty Is based only on the day the manufac-
turing or processing was completed. For example, If It takes
3 days to manufacture a substance In violation of TSCA §5,
the penalty would be assessed for the day the manufacture of
the substance was completed (day 3).

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—26—
Violations which warrant daily penalties are those which
impair the Agency’s ability to assess the risks to public
health or the environment. These penalties are assessed from
the date of occurrence to the date of discovery.
Per—day penalties will be assessed for the following viola-
tions:
0 Withholding information or submitting false or mislead-
ing information
• Failure to generate reports as required by a TSCA §5(e)
or 5(f) action
0 Noncompliance with TSCA §5(e) and .5(f) orders,
rules, and Injunctions (chemical control aspects)
• Noncompliance with research and development exemption
restrictions (violation of adequate warning and ex-
pert supervision requirements)
O Commercial use of an illegally produced substance
0 Noncompliance with exemption restr9ctions under 40
CFR Parts 720 and 723 (chemIcal control aspects)
0 Failure to notify
Penalties for recordkeeping violations will be assessed
on a one—time basis. Violations of these types do not gener-
ally pose as great a risk to public health or the environment.
The violations arise from a single violative act.
One—day penalties will be assessed for the following
violations:
• Noncompliance with section 5(e) and 5(f) orders,
rules, and injunctions recordkeeping provisions only.
The Agency reserves the right to assess per day pen-
alties for recordkeeping violations when compliance
with a requirement of a TSCA §5 action, rule or
injunction cannot be verified.
• NoncomplIance with exemption restrictions under 40
CFR Parts 720 and 723 involving recordkeeping
provisions.
0 Notice of Commencement violations. The Agency re-
serves the right to charge a per day violation
in those cases where the notice was intentionally
withheld by the company.

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—27—
Multiple Violations/Chemicals
Multiple violations of a TSCA §5 action, rule, or injunc-
tion will be assessed separately for each distinct violation.
Where more than one chemical substance is In violation, penal-
ties will be assessed for each violative chemical.
Adjustment Factors
Voluntary Disclosure
This is an activity which the Office of Compliance Moni-
toring (0CM) wants to encourage. If EPA receives a voluntary
disclosure, the Agency can proceed with action to rectify a
situation even if the manufacturer is reluctant. Actions by
EPA to convince a violator to do the “right thing” may include
penalties issued on a per—day basis, TSCA §S7 or 17 actions,
or other additional rule—making.
Although 0CM considered including the condition that the
manufacturer acted in good faith prior to the violation and that
he ceased the violative act as soon as he had reason to know of
the violation, 0CM decided not to include this as a condition for
the 25% reduction for the following reasons: 1) If the violation
continues, EPA may assess penalties against the manufacturer for
each day of violation. 2) In cal cul ating the penal ties for vio-
lations after the violator knew of the violation, a culpability
factor for those days may be added. 3) If the violator intended
to violate ISCA prior to disclosing the violation, the penalties
for the entire period of violation may be increased based on a
culpability finding. 4) If the violator does not act to rectify
the situation, his penalties may be increased based on attitude
if no finding of culpability is made. 5) Irrespective of the
circumstances of the violation, the Agency wants the manufacturer
to report it.
Immediate Voluntary Disclosure
0CM wants to further encourage prompt reporting. There-
fore, an added Incentive is provided so that the Agency is
notified soon after the manufacturer has reason to know of a
potential violation.
History of Noncompliance
As a further incentive for the voluntary disclosure of
violations, the Agency has decided to forego the imposition of
penalty increases for a history of noncompliance in assessing
penalties for voluntarily disclosed violations.
However, a voluntarily disclosed violation does constitute
a violation and is to be used to increase penalties for future
violations which the Agency discovers.

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Definitions
Consumer — Any person who uses a chemical substance for any
purpose.
Off—site Restrictions — Off—site restrictions are those re-
strictions placed on a substance after it leaves the original
site of manufacture or processing.
On—site Restrictions — On—site restrictions are those restric-
tions Imposed upon a Company by EPA through a TSCA §5 actIon,
rule, or Injunction at the site of manufacture or processing.
Recordkeeping — Recordkeeping is that information the Agency
requires the Company to retain at its premfses and provide
to EPA upon request.
Reports — Reports are those data the Agency is requiring the
Company to submit to EPA under TSCA §5.

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APPENDIX 1
EXAMPLES
Failure to Notlf
Example 1
A company has produced a chemical substance, which is not on
the Inventory, for 5 years, with production occurring on 50
days each year, and 1,000 pounds of the substance produced
on each day of production. The chemical substance Is consumed
in another chemical reaction. The company stops production
Immediately upon discovery of the violation, voluntarily
discloses the violation within 30 days, submits a PMN within
30 days and takes all the steps EPA requests of them. The
PMN goes through review without any health or environmental
concerns being raised. The company Is charged with a failure
to submit a PMN, level 4, signifIcant, per—day.
$6,000 X 5 X 50 = $1,500,000
80% reduction in penalty warranted — $1,20fJ,000
Final Penalty — $300,000
Example 2
A company has produced a chemical substance, which Is not on
the Inventory, for 4 years with production occurring 50 days
per year, and 8,000 pounds of the substance produced on each
day of production. The chemical substance is further processed
by the company on 100 days per year, 4,000 pounds processed
on each day and sold in an end—use product. The company
discovers the violation, Immediately stops production, volun-
tarily discloses the violation within 30 days, submits a PMN
within 30 days and takes all steps EPA asks of them. The
PMN review Identifies a substantial environmental concern
and the company subsequently enters Into a TSCA §5(e) consent
order to address this concern. The company Is charged with
a failure to submit a PMP4, level 1, major, per—day.
4 X 50 X $25,000 = $5,000,000
80% reduction in penalty warranted — $4,000,000,
Final Penalty — $1,000,000

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Exam p1 e 3 . S” “ 1 L1_4i4411”V #4.’
pany has produced a chemical substance, which is not on
nventory, for 8 years, with production taking place 25
j3 a year, and 3,000 pounds of the substance produced on
each day of production. The chemical substance is incorpor-
ated into a product which is sold to its customers for use
in a consumer p duct. The company discovers the violation
and reports it . EPA 75 days later, after it has developed a
legal substitute for the illegal chemical substance and has
been notified of a pending inspection. A PuN is not filed
as the company has no intention of making the illegally pro-
duced substance again. The company produces production
records for the substance only after missing two deadlines
for submitting the records. The company is charged with
a failure to submit a PMN, level 3, significant, per—day.
$10,000 X 8 X 25 = $2,000,000
15% penalty adjustment upward for attitude — $300000
Final Penalty — $2,300,000
Example 4
A company failed to submit a Notice of Commencement to EPA.
The first day of production yielded 3,000 pounds of the
bstance. EPA discovered the violation. The company is
arged with a failure to submit a Notice of Commencement,
vel 3, —igifi -tnt , one—day.
The company r ’be charged s1f’,ooo.
Example 5
A company produced a chemical substance regulated by a SNUR,
for a significant new use as defined by the SNUR, without
submitting ‘a Significant New Use Notice to EPA. The sub-
stance was incorporated into a consumer use product. The
company produced the chemical 9 times, with 3,000 pounds
produced on each occasion. EPA discovered the violation.
The company is charged with a failure to submit a Significant
New Use Notice, level 1, major, per-day.
9 x $25,000 = $225,000

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—2—
Example 3
A company has produced a chemical substance, which is not on
the Inventory, for 8 years, with production taking place 25
days a year, and 3,000 pounds of the substance produced on
each day of production. The chemical substance is incorpor-
ated into a product which is sold to its customers for use
in a consumer product. The company discovers the violation
and reports it to EPA 75 days later, after ft has developed a
legal substitute for the illegal chemical substance and has
been notified of a pending inspection. A PMN is not filed
as the company has no intention of making the illegally pro-
duced substance again. The company produces production
records for the substance only after missing two deadlines
for submitting the records. The company is charged with
a failure to submit a PMN, level 3, significant, per—day.
$10,000 X 8 X 25 = $2,000,000
15% penalty adjustment upward for attitude — $300,000
Final Penalty — $2,300,000
Example 4
A company failed to submit a Notice of Commencement to EPA.
The first day of production yielded 3,000 pounds of the
substance. EPA discovered the violation. The company is
charged with a failure to submit a Notice of Commencement,
level 3, significant, one—day.
The company would be charged $10,000.
Example 5
A company produced a chemical substance regulated by a SNUR,
for a significant new use as defined by the SNUR, without
submitting a Significant New Use Notice to EPA. The sub-
stance was Incorporated into a consumer use product. The
company produced the chemical 9 times, with 3,000 pounds
produced on each occasion. EPA discovered the violation.
The company is charged with a failure to submit a Significant
New Use Notice, level 1, major, per—day.
9 x $25,000 = $225,000

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—3—
Example 6
An inspector discovers a study that should have been submitted
In conjunction with a PMN application. The study Involved ani-
mal testing data. The chemical substance was produced for 1 year
before the violation was detected. The company is charged with
witholding information, level 1, significant, per—day.
$17,000 X 365 = $6,205,000
Example 7
A company produces a chemical substance’under a TSCA §5(e)
order. The order requires the company to train workers and
requires the employees to wear respirators while engaged in the
manufacture of the substance. The Inspector discovers that the
company has not conducted training as required and that the
workers do not wear respirators, or have them available, while
engaged in the manufacture of the substance. Production has
taken place on 30 days with 5,000 pounds of the substance pro-
duced each day. The company is charged with two counts, fail-
ure to provide training and failure to require their employees
to wear respirators, level 2, major, per—diy.
$20,000 X 2 X 30 $1,200,000
Example 8
A company produces a chemical substance under a TSCA §5(e)
order. The order requires the company to incinerate all
wastes derived from the production of the chemical substance.
An inspector discovers that the company has. not incinerated
the wastes as required, but has been releasing the wastes to
water after primary treatment. Disposal took place on 50
days w1 th 2,000 pounds disposed of each day. The company is
charged with failure to follow the restrictions of the TSCA
§5(e) order regarding disposal, level 1, significant, per—
day.
$20,000 X 50 = $1,000,000

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-4—
Example 9
A company produces a chemical substance under a TSCA §5(e)
order. The order requires the company to either stop pro-
duction or submit a study to EPA after producing 400,000
pounds of the substance. The company submits the study to the
Agency and the study is approved. A subsequent Inspection re-
veals that the company had produced 450,000 pounds of the sub-
stance prior to submItting the study, producing 5.000 pounds
of the substance on 10 different days. The company is charged
with violation of a production ban, major, level 1, per—day.
$25,000 X 10 = $250,000
Example 10
A company has manufactured and processed a chemical substance,
which is not on the Inventory, for 8 years with manufacturing
occurring 100 days each year, 5 000 pounds manufactured each
day and processing occurring 200 days each year. with 2,500
pounds processed each day. The processed chemical substance
is Incorporated Into an end use product. An inspector dis-
covers the violation. A review of the chemical by EPA iden-
tifies a substantial environmental concern which would have
placed the the substance as TSCA §5(e) order candidate. The
company is charged with a failure to submit a PMM, level 1,
significant, per—day.
$20,000 X 8 X 100 = $16,000,000
Example 11
A company applied for and recieved a low volume exemption for
a chemical substance. An inspector discovers that the company
pr.oduced 1500 kg of the substance in 3 different years with
production occurring on 3 days each year, 500 kg produced
each day. The chemical substance would have had a TSCA §5(e)
order Issued If It had not been granted a low volume exemption.
The chemical substance was distributed to customers. The com-
pany would be charged with a failure to file a PMN, level 1,
significant, per—day.
$20,000 X 3 X 3 = $180,000

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—5.-
Example 12
A company produced a chemical substance which is not on the
Inventory, for 5 years, with production occurring on 50 days,
5,000 pounds produced each day. The chemical substance was
further processed for. 100 days each year with 2,500 pounds of
the substance processed each day. The finished product con-
taining the chemical substance was distributed to consumers.
The chemical substance was a polymer that otherwise would have
qualified for a polymer exemption. The company is charged
with failure to file a PMN, level 5, significant, per—day.
$3,000 X 5 X 50 = $750,000
Example 13
Company A solicited several manufacturers to produce a chemical
substance for them. They were advised by one company that the
substance did not appear on the Inventory and that a PMN would
have to be filed prior to manufacturing. Another company agreed
to produce the chemical for Company A. Company A commercially
used the chemical substance for 5 years, 1 0 days per year,
processing 3,000 pounds of the substance on each occasion.
EPA discovered the violation at the manufacturing company and
charged the manufacturing company with a failure to file a PMN.
The PMN was filed and no problems were found with the chemical
substance auring the PMN review. A subsequent Inspection of
Company A discovered the letter from the manufacturer who had
advised Company A of the status of the chemical. Company A was
charged with commercial use of an illegally manufactured sub-
stance, level 3, major, per—day.
5 X 100 X $15,000 = $7,500,000

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1
Failure to Notify
Failure to submit a PMN
order or exemption when
to consumers or further
company.
PER—DAY/ NATURE
ONE—DAY
Per—day
Per— day
Per— day
Per—day
Per—day
Per—day
One—day
VIOLATION
not subject to a TSCA §5(e) or 5(f)
the substance was not distributed
processed for commercial use by the
Filure to submit a PMN not subject to a TSCA §5(e) or 5(f)
order or exemption when the substance was distributed to
consumers or further processed for commercial use by the com-
pany.
Failure to submit a PMN when the substance is or would have
been the subject of a TSCA §5(e) or 5(f) action but was not
either distributed to consumevs or further processed for
commercial use by the company. —
Failure to submit a PMN when the
been the subject of a TSCA §5(e)
substance was either distributed
processed by the company.
substance Is or would have
or 5(f) action and the
to consumers or further
LEVEL
4
3
2
1
5
4
3
HA
HA
HA
HA
HA
HA
HA
Failure to submit a PMN for a chemical substance which would meet
all requirements for a polymer exemption under 40 CFR 723.250.
except that the company did not file for an exemption.
Failure to submit a PMN for a chemical substance which would meet
all requirements for a polymer exemption under 40 CFR 723.250,
except that the company did not file for an exemption and the
substance was further processed for commercial use, distri-
buted to consumers, or released uncontrolled into the envi-
ronment.
Failure to submit a Notice of Commencement.
HA — Hakard Assessment
CC — Chemical Control CADG - Control-Associated Data—Gathering

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V It.) LA Ti 0;i
lure to submit 3 timely Notice of Commencement (early or
late submission, up to 30 days prior to manufacture or 30 to
60 days after manufacture).
Failure to submit a timely Notice of Commencement (early or
late subr ’iission, more than 30 days prior to manufacture or
more than 61J days after manufacture).
WittihoiJing information or submitting false or misleading
information with regard to a PMN, Significant New Use
Notice, or exc:nption request.
Submission of a false Ilotice of commencement.
Noncompliance with TSCA §5(e) or 5(f) Orders, Rules or
Injunctions and Significant New Use Ru’es
Violation of on—site restrictions.
Violation of off-site restrictions where the substance was
either processed by another firm or distributed to consumers
or released uncontrolled into the environment.
Failure to submit a Significant New Use Notice when the sub-
stance was not distributed.
Failure to submit 3 Significant New Use Notice when the sub-
stance was distributed to consumers.
“iolation of production ban or restriction.
Failure to generate reports as required.
LEVEL
6
4
1
1
2
1
2
1
1
2
PE R—DAYI
ONE—JAY
One-day
One-day
Per—day
(The—day
Per—day
Per—day
Per-day
Per-day
Per—day
Per-deS’
2
5
Amended
1IATIJRE
HA
IA
HA
HA
Cc
Cc
CC
CC
cc
hA

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3
VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Failure to generite reports as required, where th€ ubstance
was either processed by another firm or distributed to 1 Per—day HA
consumers or released uncontrolled into the environment.
Late submission of required reports where the substance was
not distributed or processed. 4 Per-day HA
Late submission of required reports where the substance was
either processed by another firm or distributed to consumers 3 Per—day HA
21. released uncontrolled into the environment.
Withholding information or submitting false or misleading 1 Per—day - HA
information.
Violation of the recordkeeping provisions where the firm
produces the missing records within 5 days of an EPA request. 4 One—day CADG
Violation of the recordkeeping provisions where the firm
cannot produce the missing records within 5 days of an EPA 3 One—day CADG
request except as specified on page 26 of the policy.
Commercial Use of an Illegally Produced Substance
Commercial use violations will be charged In three circumstances:
1. When a company processes or uses a chemical substance which
it did not manufacture and it has reason to know Is not on
the Inventory.
2. When a chemical substance was manufactured or imported ille-
gally on just a few occasions and processed over a long per—
lod of time, the substance would have been subject to a TSCA
§5(e) or 5(f) order, and the activity could have caused
substantial endangerment to health or the environment.

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4
VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Comn rcial use violations will be assessed as follows:
Violation where the substance was not processed by or dis- 4 Per-day CC
tributed to others after receipt by the user.
Violation where the substance was further processed by or 3 Per—day CC
distributed to others.
Violation where the substance Is or would have been the subject
of a TSCA §5(e) or 5(f) actIon but was not processed by or 2 Per—day CC
distributed to others. -
Violation where the substance Is or would have been the subject
of a TSCA §5(e) or 5(f) action an was either processed by 1 Per—day CC
others or released uncontrolled into the environment.
Noncompliance with Test Marketing Exemption Restrictions
Overproduction by 10% or less. 3 Per—day CC
Overproduction of more than 10% would be charged as a failure to
submit a PMN.
Violation of exposure related, on—site restrictions. 2 Per—day CC
Violation of recordkeeplng provisions except as specified on 4 One—day CADG
page 26 of the policy.
Violations of the off—site control provisions of a TME where
the substance was either distributed to consumers or was 1 Per—day CC
released uncontrolled Into the environment. —
Noncompliance with Research and Development Exemption Restrictions
Violations regarding the labeling of the R&D substance where
the substance was further processed by another firm. 2 Per—day CC

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VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Violations regarding the labeling of the R&D substance where
the substance was either distributed to consumers or was 1 Per—day CC
released uncontrolled Into the environment.
Please note that any violation of an R&D exemption other
than failure to adequately label the R&D substance, would
cause the charge to be a failure to submit a PMN.
Noncompliance with Low Volume Exemption Restrictions
Violations regarding the notification of customers of the re-
strictions on use of the substance. 2 Per—day CC
Violations regarding the failure to notify EPA of any changes
i n si te or use of the exempted. chemical. 2 Per—day CC
Violations of the recordkeeplng provisions of the low volume 3 One—day CADG
exemption except as specified on page 26 of the policy.
Violations of the 1,000 kg. production limit would be viewed
as a failure to submit a PMN.
Violations regarding the failure to maintain required exposure 2 Per—day CC
controls.
Noncompliance with the Instant Photographic and Peel-Apart
Film Article Exemption Restrictions
Failure to limit manufacturing and processing to site(s)
listed in the exemption application. 5 Per—day CC
Distribution in commerce or use of a peel—apart film article
containing a new chemical substance prior to its being cleared
through the PMN process would be considered a failure to -
submit a PMN and subject to the penalties thereunder.

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6
VIOLATION LEVEL PER—DAY/ NATURE
ONE-DAY
Failure to follow the conditions of manufacture or instant
photographic or peel—apart film articles where the substance 2 Per—day CC
would not have been subject to a TSCA §5(e) or 5(f) order.
Failure to follow the conditions of manufacture for Instant
photographic or peel—apart film articles where the substance 1 Per—day CC
would have been subject to a TSCA §5(e) or 5(f) order.
Violation of the recordkeeping provisions of this exemptIon 3 One—day CADG
except as specified on page 26 of the policy.
Noncompliance with Polymer Exemption Restrictions
Violations regarding the submission of test data with the 1 Per—day HA
exemption application.
Violations of the recordkeeping provisions of the polymer
exemption except as specified on page 26 of the policy. 4 One—day CADG
All other violations of the polymer exemption would be
charged as a failure to submit a PMN.
Production
Production of a chemical substance after submission of a
PMN but prior to the expiration of the PMN review period. 3 Per—day HA

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7
VIOLATION
Production of a chemical substance after submission of a PMN
but prior to the expiration of the PMN review period when
the substance becomes or would have been the subject of a
TSCA §5(e) or 5(f) action or the substance was distributed to
consumers.
Production of a chemical substance prior to the expiration of
the PMN review period when the substance becomes or would have
been the subject of a TSCA §5(e) or 5(f) action and the substance
was distributed to consumers.
Other Violations
Any other violation not listed above.
EXTENT MATRIX
LEVEL
2
1
4
PER—DAY/
ONE—DAY
Per—day
Per-day
Per—day
Nature
A
Extent Level
C
B
Major
Significant
Minor
Chemical
>2,500 lbs
>250 lbs to 2,500 lbs
>0 to 250 lbs
Control
>1,134 kg
>113.4 kg to 1.134 kg
>0 to 113.4 kg
Control-
>10,000 lbs
‘1,000 lbs to 10,000 lbs
>0 to 1,000 lbs
Associated
>4,536 kg
>453.6 kg to 4,536 kg
>0 to 453.6 kg
Data-
Gathering
Hazard >7,500 lbs >750 lbs to 7,500 lbs >0 to 750 lbs
Assessment >3,402 kg >340.2 kg to 3,402 kg >0 to 340.2 kg
NATURE
HA
HA
HA

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8
GRAVITY BASED PENALTY MATRIX
Ci rcumstances Extent
A B C
Major Significant Minor
Levels
1 $25,000 $17,000 $5,000
High Range
2 $20,000. $13,000 $3,000
3 $15,000 $10,000 $1,500
Mid Range
4 $10,000 $ 6,000 $1,000
5 $ 5,000 $ 3,000 $500
Low Range
6 $ 2,000 $ 1,300 $200

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Sri,
)
UNITED STAT S ENVIRONMENTAL PROTECTION AGENCY
- wTIg-- WASHINGTON. D.C. 20460

JUN 81989
OFFICC OP
PESTICIDES AND TO IIC SUBSTANCES
MEMORANDUM
SUBJECT: Amendment to the TSCA §5 Enforcement Response Policy
FROM: John J. Neylan III, Director \V3
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
This memorandum amends the ISCA §5 Enforcement Response
Policy by revising the penalty for falsification of a Notice
of Commencement (MOC). This change would apply to those in-
stances where a company has submitted a Notice of Commencement
in anticipation of production or importation, the event
does not occur, and the company never does produce or import
the substance..
This change has been made in response to numerous comments
that the policy issued on August 5, 1988, created a large in-
equity in penalty when a company submits a Notice of Commence-
ment but does not produce a substance, as compared to a company
that produces a substance without submitting a Notice of Com-
mencement. In the first situation, the current ERP requires
that the violation be charged as a false NOC and would subject
the violator to per day penalties from the day the false NOC
was submi tted to the day of discovery of the violation with the
potential of very large penalties. The provision to allow for
per day penalties for each calendar day a falsification occurs,
was created for those Si tuations where the falsi ficatlon pre-
vents the Agency from making a reasoned evaluation of the chem-
ical substance. This is not the case for a false NOC. The
chemical has been reviewed and mistakenly placed on the Inven-
tory. A reasoned evaluation of the chemical substance has
been made.
Attached are the two pages affected by the change with the
necessary revisions incorporated. These pages may be inserted
into the TSCA §5 ERP in the appropriate places. If you have
any questions concerning the revi sions please contact David
Stangel of my staff at 382—3477.
Attachments

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ADDRESSEES
Mike Shapiro (TS—788)
Charles Elkins (TS—792)
Frederick F. Stiehi (LE-l34)
Mark Greenwood (LE-132A)
A.E. Conroy II (EN-342)
Diane Beal
John J. Neylan III
Mike Wood
David Dull
Jerry Stubbs
Phyllis Flaherty
Bob Zisa
Sherry Sterling
Maureen Lydon “
Ken Kanagalingam
Jan Bearden
Jake MacKenzie
Western Regional Compliance Director
Dean Hill, NEIC
I Louis F. Gitto, Director Marvin Rosenstein, Chief
Air Management Pesticide & Toxic Subs. Br
II Barbara Metzger, Director Ernest Regna, Chief
Environmental Services Div. Pesticides & Toxic Subs. Br
Ill Thomas C. Voltaggio Larry Miller, Chief
Acting Director Toxic 6 Pesticides Branch
Hazardous Waste Management
Division
IV Winston A. Smith, Director Richard DuBose, Chief
Air, Pest. & Toxic Mangt. Pesticides & Toxic Subs. Br
Division
V William H. Sanders III, Dir Phyllis Reed, Chief
Environmental Services Div Pesticides & Toxic Subs. Br
VI William B. Hathaway, Dir Robert Murphy, Chief
Air, pesticides & Toxic Subs. Pesticides & Toxic Subs. Br
Division
VII William A. Spratlin, Dir Carl Walters, Acting Chief
Air and Toxics Division Pesticides & Toxic Subs. Br
VIII Irwin L. Dicketein, Director Alvin Yorke, Chief
Air and Toxics Division Toxic Subàtances Br

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—2--
IX David P. Howekamp, Director Davis Bernstein, Chief
Air Management Division Pesticides & Toxic Subs. Br
X Gary O’Neal, Director Kenneth Feigner, Chief
Air and Toxics Division Pesticides & Toxic Subs. Br
cc: Michael Walker (LE—134P)
Jim Willis (TS—788)
Alicia Tenuta (A—107)

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tO Sr 41
,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASH INGTON D.C. 20460
4 L PRO1 ’
MAY 15 1981
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Final Enforcement Response Policy fo CA J..L
FROM: John J. Neylan I II, Director
Policy and Grants Division
Office of Compliance Monitori
TO: Addressees
Attached is the final revised Enforcement Response Polcy
(ERP) for TSCA § 8, 12 and 13. The final ERP remains very similar
to the proposed ERP issued on March 27, 1987 with changes made in
three areas. Failure to maintain TSCA §8(c) records in a manner
that meets the standard required in the rule has been made a sig-
nificant, level 3, one—day violation ($10,000). The second change
made is the addition of a violation for failure under the TSCA
§8(a) Inventory Update Rule to keep records showing that the manu-
facturer Is not subject to reporting. under the rule (major, level
6, $2,000). The third change to the ERP is a modification in the
per day assessment for violations of TSCA §8(a) Chemical Specific
rules. The per day assessment is now the the base penalty divided
by 360. The maximum penalty for failure to report is now $34,189,
while the maximum penalty for late reporting Is $12,067.
This ERP supercedes the previous TSCA § 8, 12 and 13
ERP and Its two succeeding amendments. I would once again like
to thank the Regions for their comments and cooperation in formu-
lating this ERP, especially the Regional participants In the
workgroup. If you have any questions concerning this final ERP,
please contact David Stangel of my staff at (FTS) 382—7825.
A discussion of the comments is attached.
Attachments

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Addressees
Charles Elkins
Frederick F. Stiehi
Stanley Abramson
Ken Shiroishi
Phyllis Flaherty
John Martin
John J. Neylan III
Ralph Turpin
Mike Wood
Gerald Stubbs
Dexter Goldman
Michael Walker
Margaret Rostker
Michael Stahl
(TS-792)
(LE-134A
(LE-1 32A
(EN-342)
II
SI
II
II
II
II
(LE—134P)
(TS-788)
(TS—788)(Asbestos documents)
Jake Mackenzie
Western Regional Compliance Director
A. Charles Lincoln
Eastern Regional Compliance Director
Louis F. Gitto, Director
Air Management Division, Region I
Barbara Metzger, Director
Environmental Services Division, Region II
Stephen R. Wassersug, Director
Hazardous Waste Management Division, Region III
Winston A. Smith, Director
Air, Pesticides and Toxics Management Division, Region IV
William H. Sanders III, Director
Environmental Services Division, Region V
William B. Hathaway, Director
Air, Pesticides, and Toxics Division,
William A. Spratlin, Director
Air and Toxics Division, Region VII
Irwin L. Dlcksteln, Director
Air and Toxics Division, Region VIII
Jeffrey Zellkson, Acting Director
Toxics and Waste Management Division,
Gary O’Neal, Director
Air and Toxics Division, Region X
Region VI
Region IX
Regional Pesticides and Toxic Substances Branch Chiefs

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RESPONSE TO COMMENTS
Comment:
The penalties for TSCA §8(a) Chemical Specific reporting are
too high and should be assessed as a one-day penalty in the same
way that Inventory violations are handled.
Re ponse:
The Office of Compliance Monitoring and the Office of Toxic
Substances feel very strongly that penalties for TSCA §8(a)
CAIR and PAIR violations be higher than those for TSCA §8 Inventory
violations. In most cases, the Agency is asking for the informa-
tion under very strict statutory or court imposed deadlines and
the information is used to determine how the Agency will regulate
a chemical substance. The failure to report data in a timely man-
ner could sertpusly impair the decision to regulate a chemical
substance. We are, however, sensitive to the Region’s concerns
regarding the amount of the penalties. The ERP, therefore, has
been amended to reduce the amount of the per day penalty by di-
viding the base penalty by 360 instead of 180. This would re-
suit in a maximum penalty for failure to report violations of
$34,189, with $12,067 being the maximum assessed for late report-
Ing. Both OTS and 0CM feel that while the penalties are higher
than those in the previous ERP, they are appropriate and shall
remain per day violations.
Comment:
The TSCA §8(a) Inventory Update penalties are too high con-
sidering that many of the violators will probably have multiple
violations, due to Ignorance of the regulations.
Response:
While we agree that there may be Instances where a manufac-
turer is ignorant of the regulations, these instances should not
dictate the penalty structure. The Inventory Update Rule Is con-
structed In such a way that most small manufacturers (the group
most likely to be ignorant of the rule) are exempt from reporting.
In the event that a manufacturer fails to report on a large num-
ber of substances, the size of the business may mitigate the pen-
alty or the company could undertake other activities to mitigate
the penalty. If a large manufacturer fails to report on a large
number of substances, a substantial harm may have occurred to the
Agency’s efforts to characterize exposure and the penalties would
be appropriate.

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—2—
Comment:
The penalty policy is inconsistent in that a failure to re-
cord TSCA §8(c) allegations at all is categorized as a significant,
level 1 violation ($17,000) while a company that does keep allega-
tions but fails to keep them in the manner prescribed is assessed
a major, level 2 violation ($20,000).
Response:
We agree that this situation is inequitable. The ERP has
been amended so that a failure to maintain TSCA §8(c) records
in a manner that meets the standard required in the rule would
be a significant, level 3, one—day violation ($10,000). There
may be instances of a failure to maintain records or reports in
a manner that meets the standard required in other rules so the
violation will be reflected as both a level 2 and a level 3 vio-
lation. The ERP distinguishes between TSCA §8(c) records and
other records.
Comment:
The ERP should incorporate some method of employing gross
market share/volume categories when determining penalties.
Response:
The workgroup has discussed a number of methods of factoring
market share or volume into the penalty calculations and has not
been able to develop a workable system to incorporate these para-
meters into hazard assessment. Basically, the workgroup does not
believe that harm can be related to market share. Other problems
with such an approach are accurately determining market share,
dealing with those chemicals where the Agency is concerned with
very small amounts of a substance, and the potential for divulging
confidential business information. -
Comment:
The current system of referring TSCA §13 cases to the Region
where the Importer Is located rather than allowing the Region where
the entry, and subsequent violation, occurred to take the case
is inequitable.
Response:
0CM agrees that Regions where the majority of importation
occurs bear a much greater resource burden without receiving pro-
per recognition for the resources expended. We are reluctant to
once again amend the SPMS reporting system to include information
on referrals to other Regions. We propose to include this infor-
mation on the PC Tracking System and have these referrals be re-
flected in workload modeling.

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—3—
Comment:
Regions should charge brokers with violations of TSCA §13 as
a means of acheiving compliance with the import regulations.
Response:
This office is deeply concerned with the practice of bringing
actions against a broker as a means of reducing the number of ISCA
§13 violations. The regulations at 40 CFR 707.20 require the im-
porter to certify compliance with TSCA for all chemical substances
Imported. The Importer is clearly the responsible party regard-
less of the type of contractual arrangement the importer may have
with the broker. It is the responsibility of the importer to do
business with responsible brokers. While we agree that brokers
are responsible for many of the violations that occur and a tech-
nical assistance program would be of great benefit to educate the
brokers, the importers are ultimately responsible for compliance
with TSCA notwithstanding the actions of their agents. An Importer
may wish to recover damages from a broker after the Agency has
concluded its civil action, but that is a matter for which the
Agency has no concern. National policy requires that civil ac-
tions be directed to the importer of record. Questions have been
raised as to the legality of directing any type of enforcement
actions towards the broker which 0CM and OECM are attempting to
address. Regions may wish to consider an educational campaign
for those brokers who commit violations of TSCA §13, along with
an informal warning letter to the broker stating the violation.
Comment:
Headquarters should reconsider the policy of concurrence for
all cases settled under the new ERP, especially those taken under
TSCA §13.
Response:
This ERP was revised in part to answer the concerns of the
Regions that the penalties under the old ERP were unrealistically
high and based mainly on when EPA conducted an Inspection rather
than the potential harm that could have occurred. We feel that
these concerns have largely been answered by this document.
While the penalties assessed under this ERP will generally be
less than those In the past, we are concerned that penalties may
be reduced as they were in the past. We feel that the differ-
ences between the penalty assessed and the penalty collected
should be much smaller under this ERP than in the past. We
are more concerned with penalties under TSCA §8, but feel It
would be beneficial to monitor the penalties assessed for all

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—4 —
violations under this ERP. We anticipate relaxation of con-
currence for TSCA §13 violations to be forthcoming after re-
viewing the actions taken under this ERP. However, given the
wide disparity in how the Regions administer actions under
TSCA § 8, 12 and 13 at this time, we feel that requiring con-
currence as a means of administering the new ERP is prudent.
Comment:
0CM should distribute drafts of ERPs to the Offic&s of Re-
gional Counsel as well as the Regional program offices.
Response:
At the insistence of the Office of Enforcement and Compliance
Monitoring (OECM), drafts of ERP’s are directed to that office with
OECM being responsible for transmitting these documents to the ORC.

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MAY 151987
RECOROKEEPING AND REPORTING RULES
TSCA SECTIONS 8, 12 AND 13
ENFORCEMENT RESPONSE POLICY
OFFICE OF COMPLIANCE MONITORING
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
THE U.S. ENVIRONMENTAL PROTECTION AGENCY

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Reporting and Recordkeeping Rules Enforcement Response Policy
CONTENTS
Ir troduction
Summary of Requirements/Rules Covered. . . . . . . . . . 1
Determining the Level of Action
Notice of Noncompliance . . . . . . . . . . . . . . . . 3
Administrative Civil Penalty . . . . . . . . . . . . . . 3
Injunctive Action . . . . . • • • • • • • • • • • • • 4
Criminal Sanctions . . . . . . . . . . . . . • • • • • • 4
Multiple Remedies . . . . . . . . . . . . . . . . . . . 5
Assessing an Administrative I ena1ty
Summary of the Penalty Policy . . . . . . . . . . . . . 6
Explanation of the Penalty Policy . . . . . . . . . . . 16
Appendix 1: Caps for Per Day Vio at1ons
Appendix : Examples

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INTRODUCTION
Section 8 of the Toxic Substances Control Act (TSCA) author-
i zes EPA to require chemi cal manufacturers, importers and pro-
cessors to keep records and to report certain information. TSCA
§12 requires the submission to EPA of information about chemical
exports. The TSCA §13 rule requires the submission of certifica-
tion statements concerning import shipments of chemical substances.
These reporting and recordkeeping provisions have similar types
of requirements, and therefore, similar types of violations. For
this reason, this Enforcement Response Policy addresses all these
provisions as ISCA reporting and recordkeeping requirements.
Failure to comply with the recordkeeping and or reporting
provisions of TSCA is a violation of TSCA § 15(3)(A) and 15(3)(B)
and subject to the remedies in TSCA §16.
Summary of Requirements/Rules Covered
TSCA §8(a) Inventory — Required reporting during 1977 by persons
who manufactured and/or imported reportable chemicals. (At this
date, these violations are most likely failures to report or
falsified reports.) (40 CFR 710)
TSCA §8(a) Inventory Update - Requires reporting by persons who
manufacture or import chemical substances which are on the TSCA
Chemical Inventory in quantities greater than 10,000 lbs. at a
specific site. Small businesses and certain classes of chemicals
are excluded. (51 FR 21438, June 12, 1986, 40 CFR 710)
TSCA §8(a) Preliminary Assessment Information Reporting Rule
( PAIR ) — kequires reporting by persons who manufacture or im-
port listed chemicals in quantities greater than 1,100 lbs.
per site. Small businesses are excluded. (47 FR 26992,
June 22, 1982, 40 CFR 712)
TSCA 8(a) Asbestos Reporting — Required reporting by persons
who mined, manufactured, imported, or processed asbestos by
November 1, 1982. Exemptions included small businesses, dis-
tributors, and builders. (47 FR 33198, July 30, 1982, 40 CFR 763)
TSCA §8(a) Chemical Specific Rules
ISCA §8(a) P-TBBA, P-TBT, P-TBB - 40 CFR 704.33
ISCA §8(a) Chlorinated naphthalenes - 40 CFR 704.83
TSCA §8(a) Chlorinated terphenyl - 40 CFR 704.85
TSCA §8(a) Hexachioronorbornadiene — 40 CFR 704.142
TSCA §8(a) 4,4’-methylenebis(2-chloroanhline)(MBOCA) —
40 CFR 704.175

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-2-
TSCA §8(a) Polybrominated biphenyls (PBBs) — 40 CFR 704.195*
TSCA §8(a) Iris (2,3—dibromopropyl) phosphate - 40 CFR 704.205
* These rules have been “sunsetted” and replaced by SNUR’s.
TSCA §8(c) Alleged Significant Adverse Reactions — Requires
persons who manufacture, import, process, or distribute chem-
ical substances or mixtures in commerce to keep files of alle-
gations of significant adverse reactions and provide this in-
formation to EPA upon request. Exemptions include persons
whose activities consist of mining or other solely extractive
functions; processors who are not also manufacturers if none
of the processors’ sites are engaged in activities described
in IC 28 or S IC 2911; and persons who are solely distributors
or retailers. (48 FR 38178, August 22, 1983, 40 CFR 717;
amended 50 FR 46766, November 13, 1985, 40 CFR 717)
TSCA §8(d) Health and Safety Studies Submission-. — Requires
persons who manufacture, import, process, or propose to manu-
facture, import, or process listed chemicals to submit lists or
copies of unpublished studies to EPA. (47 FR 38780, September
2, 1982, 40 CFR 716 amended September 15, 1986, 51 FR 32720)
TSCA §8(e) Substantial Risk Reporting — Requires persons who
manufacture, import, process, or distribute in commerce a chem-
ical substance or mixture and who obtain “new” information which
reasonably supports the conclusion that such substance or mix-
ture presents a substantial risk of injury to health or the en-
vironment to report such information to EPA within 15 days.
(Policy Statement, 43 FR 11110, March 16. 1978)
TSCA §12 Exports — Requires persons who export chemicals subject
to final and certain proposed rules and orders under sections
4, 5, 6 and 7 of TSCA to notify EPA of the country of destina-
tion the first time a chemical is shipped to that country during
a calender year. (45 FR 82844, December 16, 1980, 40 CFR
707.60)
TSCA §13 Imports — Requires persons who import chemical sub-
stances to certify that each shipment is in compliance with TSCA
or is not subject to TSCAS (48 FR 34734, August 1, 1983, 19 CFR
12.118 through 12.127 and 127.28 amended, and 40 CFR 707.20)
Future TSCA §8 Rules — This policy also covers all future
rules promulgated under TSCA §8 or amendments to the above
rul es.

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-3—
DETERMINING THE LEVEL OF ACTION
Enforcement alternatives include a notice of noncompliance,
a civil penalty, injunctive relief, criminal action, or some
combination of these actions.
Notice of Noncompliance
A notice of noncompliance (NON) is appropriate where:
(1) the violation is a first-time violation of ISCA § 12 or 13
where there are no other TSCA violations for the shipment or
(2) minor violations of TSCA §8 as specified below where the
violator has not received a previous NON for a violation
of that particular subsection. Violations of TSCA §8
which warrant NON’s are:
o Minor technical omissions, I.e., failure to supply
required noncritical information (such as, the phone
number of a technical contact).
o FaIlure to use certified mail in making a notification
(as required by a rule);
o Report sent to Incorrect address but correctly Identified
as a TSCA §8(_) submission;
o Report sent to correct address but not identified as a
TSCA §8(_) submission;
Administrative Civil Penalty
An administrative civil penalty will be the appropriate
response for most violations of these regulations.
Concu rrence
Civil penalties are to be assessed according to this policy.
Regional enforcement personnel must obtain written concurrence
from the Office of Compliance Monitoring of the Office of Pesti-
cides and Toxic Substances prior to Initiating a civil adminis-
trative penalty for TSCA § 8, 12 and 13. Reductions for settle-
ment purposes require the concurrence of 0CM as well and must
be in accordance with the TSCA Penalty Policy and this ERP.

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-4 -
Each reduction must be justified in the consent agreement and
final order and specific dollar amounts attributed to each re-
duction. Headquarters may relax concurrence requirements on
a Region by Region basis after the Regions have gained experi-
ence with actions under these rules and the ERP.
Injunctive Action
Injunctive action under TSCA may be appropriate in certain
circumstances. Although §17 of TSCA can be a very effective
tool in obtaining compliance, it is also more resource inten-
sive than a civil penalty action. In addition, it has been
the Agency’s experience that a civil penalty action is usua1ly
sufficient to obtain compliance. For these reasons, the Agency
believes that the use of ISCA §17 remedies generally should
be limited to those instances where a civil penalty action will
not result in sufficiently swift compliance to protect human
health or the environment. For example, injunctive action may
be used to require a company to maintain records where the atti-
tude of the violator indicates that this would not be done
otherwise or where there is a repeated history of failure to
keep records.
Criminal Sanctions
Criminal sanctions pursuant to TSCA l6(b) are the most
serious sanctions available for violations of the recordkeeping/
reporting rules. Accordingly, criminal sanctions may be sought
in situations that —— when measured by the nature of the conduct,
the compliance history of the subject(s) or the gravity of the
health or environmental consequences —— reflect the most serious
cases of misconduct.
Several factors distinguish criminal cases from administrative
or civil actions. First, criminal sanctions will ordinarily be
limited to cases in which the prohibited conduct is accompanied
by evidence of “guilty knowledge” or intent on the part of the
prospective defendant(s). TSCA imposes criminal penalties only
for violations of the Act which are committed “knowingly or
willfully”.
A second factor to consider is the nature and seriousness of
the offense. As a matter of resource allocation, EPA will inves-
tigate and refer only the most serious forms of misconduct. Of
primary importance to this assessment is the extent of environmental
contamination or human health hazard that resulted from, or was
threatened by, the prohibited conduct. Also of significance is
the impact, real or potential, on EPA’s regulatory functions.

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Third, the compliance history of the individual(s) or per-
son(s) for a potential criminal case is important. Criminal
sanctions become more appropriate as incidents of noncompliance
increase. While not a prerequisite, a history of noncompliance
will often indicate the need for criminal sanctions to achieve
effective individual deterrence.
Multiple Remedies
There may be unusual instances where a particular situation
will present facts that suggest that more than one final action
should be taken. 0CM does not encourage the use of multiple re-
medies for the reasons discussed below. The purpose of this
Section is to outline when multiple remedies are appropriate.
Criminal Sanctions
Simultaneous civil and criminal enforcement proceedings are
legally permissible, United States v. Kordel , 397 U.S. 1 , 11
(1970), and on occasion are clearly warranted. These cases
should be the exception rather than the rule. When parallel
proceedings are contemplated, please refer to the Office of En-
forcement and Compliance Monitoring guidance on parallel proceed-
ings (January 23, 1984).
Notice of Noncompliance
In general, a notice of noncompliance should not be used in
conjunction with any other final remedy. Where a particular
situation presents several violations, some of which would merit a
notice of noncompliance, while others would merit civil penalties,
no notice of noncompliance should be sent. Instead, an adminis-
trative penalty action should be initiated, pleading all viola-
tions, with no penalties for minor infractions which would other-
wise warrant an NON.
Civil Administrative Penalties and Specific Enforcement
The criteria outlined in this section antIcipate that civil
penalties and specific enforcement (injunctive action) will be
used sequentially. There may, however, be instances where the
concurrent use of these remedies is appropriate. If the Region
deems this to be appropriate in any case, It should consult with
0CM and OECM before bringing either action.

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ASSESSING A CIVIL ADMINISTRATIVE PENALTY
Summary
Backgro
of thiPenaIty Policy
und
The TSCA Civil Penalty Policy, published in the Federal
Register on September 10, 1980, establishes a system tor deter-
mining penalties in administrative actions brought pursuant to
TSCA §16. Under that system, penalties are determined in two
stages: (1) determination of a “gravity based penalty” (GBP),
and (2) adjustments to the gravity based penalty.
To determine the gravity based penalty, the following factors
affecting a violafion’s gravity are considered:
o The nature of the violation.
o The “extent” of environmental harm that could result
from a given violation.
o The “circumstances” of the violation.
These factors are incorporated in a matrix which allows de-
termination of the apppropriate gravity based penalty.
Once the gravity based penalty has been determined, upward
or downward adjustments to the penalty amount are made in con-
sideration of these other factors:
O Culpability,
o HIstory of such violations,
o Ability to pay,
o Ability to continue in business, and
o Such other matters as justice may require.
The TSCA Civil Penalty Policy system provides a framework
for the development of individual penalty guidances for each
rule promulgated under TSCA. This document sets forth Agency
policy for the use of the GBP Matrix to assess penalties for
specific violations of TSCA § 8, 12 and 13 and regulations
promulgated pursuant to these sections.

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—7—
Applicability ___________ ______
This policy is immediately applicable and should be used
to calculate penalties for all administrative actions concern-
ing TSCA § 8, 12 and 13 instituted after the date of this policy,
regardless of the date of violation. Pending cases should be
reviewed to determine whether the penalty calculated under this
policy is lower than the penalty in the civil complaint. If
this policy yields a lower penalty, an amendment to the com-
plaint should be made to substitute the lower penalty. This
policy should not be used to raise penalties in existing actions.
Plo case should be settled for an amount higher than the penalty
which this policy wouldyield.
Calculation of the Gravity Based Penalty
Penalties for TSCA § 8, 12 and 13 violations vary depending
on tne extent, circumstances, whether penalties are to be calcu-
lated as one day assessments versus per day assessments, and by
capping the number of days for which a violation may be assessed
as appropriate. In establishing each of these, the Agency con-
sidered the following factors in a comparative manner:
o Impact on the Agency’s decision making process.
o Relative degree of harm caused by failure to comply.
o Timeframes In which the Agency decision making process
generally occurs.
o Time to generate information not reported.
O Relative costs of studies.
O Likelihood that sufficient information is available from
other sources.
° Type of information involved, i.e., human exposure versus
animal toxicity studies and allegations versus actual data.
The Gravity Based Penalty (GBP), a function of the nature,
circumstances and extent of each violation, is to be determined
by using the following matrix:

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-8-
EXTENT
A
B
C
CIRCUMSTANCES
Levels
1
High Range
2
MAJOR SIGNIFICANT

$25,000 $17,000
$20,000 $13,000
MINOR
$5,000
$3,000
3
Mid Range
4
$15,000
$10,000
$10,000
$6,000
$1,500
$1,000
5
Low Range
6
$5,000
$2,000
$3,000
$1,300
$500
I
$200
After determining the initial or ubase penalty” from the ma-
trix for the first day of violation, add the penalty for each addi-
tional day of violation based on the instructions in the “Penalty
for Each Day of Violation” heading. Whether a penalty is to be
assessed as a one day assessment or as a continuing violation on
a per day basis Is included in the Circumstances sections. Days of
violation are based on calender days, not workdays.
Nature
A violation may be either chemical control, control-asso-
ciated data gathering, or hazard assessment in nature. For pur-
poses of assessing a penalty, the nature of a recordkeeping/
reporting violation is “hazard assessment.”
Cl rcumstances
The first step in selecting the base penalty is to deter-
mine which level on the circumstances axis applies to the
violation.
The circumstances axis of the GBP matrix reflects the
probability that harm will result from a particular violation.
For recordkeeping and reporting rules, violations rank as fol-
lows on the circumstances axis:

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-.9-
CIRCUMSTANCE LEVE l.
LEVEL I Nonreporting for TSCA §8(e) Per day
Nonreporting for TSCA §8(e) Emergency One day
Incident of Environmental Contariination
Nonreporting for TSCA §8(d) Per day
Nonreparting for TSCA §8(c) Per day
Nonreporting for TSCA §8(a) Chemical Per day
Specific Rules
Nonreporting for Inventory Update One day
Nonreporting for Inventory One day
Failure to keep records [ not TSCA §8(c)] Per day*
Failure to record ISCA §8(c) allegation One day
False/incorrect/misleading reporting Per day*
LEVEL 2 Failure to maintain records/report in a One day
manner that meets the standard required in
the rule. TSCA §8(c) violations are level
3.
Failure to report under TSCA §8(d) involving One day
omission of study in list of studies which a
manufacturer or processor knows of but which
is not in his possession.
LEVEL 3 Failure to report completely after EPA has Per day*
requested missing information or a correc-
tion of erroneus Information.
Failure to maintain TSCA §8(c) records/ One day
report In a manner that meets the standard
required in the rule. Assess one violation
where all allegations are filed but not in
the manner presribed.
TSCA §13 VIolation (first or otherwise) One day
where a positive/negative/no certification
was submitted but the chemical does not com-
ply with other TSCA provisions.
LEVEL 4 Late reporting — For definition of late Per day*
reporting parameters, see the Compliance
Monitoring Strategy for each rule. Does
not apply to the original Inventory Rule,
TSCA §12 and TSCA §13.
TSCA §12 violations after company has One day
received a previous notice of noncompliance
for a violation of TSCA §12.

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-10-
TSCA 13 violations where a negative/no cer— One day
tification is suhmitted but the chemical is
subject and chemical is in compliance with
all other TSCA provisions as specified in
the TSCA §13 regulation and the company has
received a previous notice of noncompliance
for a violation of TSCA §13.
LEVEL 5 No violations are level 5.
LEVEL 6 Minor technical omission - Example: omitted One day
name of technical contact but included title
and phone number so the Agency was able to
reach the correct person. (See Notice of
Noncompi lance.)
TSCA §8 report sent to incorrect office and One day
was not identified as a TSCA §8(_) submis-
sion as required.
TSCA §8 report sent to incorrect office and One day
was identified as a ISCA §8 report after
company has received a previous notice of
noncompliance for a violation of the same
subsection.
TSCA 8 report sent to correct office but One day
not identified as a TSCA §8 report after
company has received a previous notice of
noncompliance for a violation of the same
subsecti on.
Failure to keep records showing that the One day
manufacturer is not subject to reporting
under the TSCA §8(a) Inventory Update
Rule.
Extent
The second step in selecting the base penalty for a specific
violation from the matrix Is to determine Its position on the
extent axis.
This axis of the GSP matrix reflects the extent of potential
harm caused by a violation. In the case of recordkeeplng/reporting
rules, harm is defined as the inability of the Agency to carry out
its risk assessment responsibilities under TSCA.
* One day for Inventory update, Inventory, TSCA §12, TSCA §13,
TSCA §8(e) ETEC’s, and TSCA §8(d) involving lists of studies
which a manufacturer or processor knows of but which are not
in his possession.

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—11—
EXTENT LEVEL
MAJOR Violations of ISCA § 8(c), 8(d), or 8(e)
which involve information which directly
interferes with the Agency’s ability to address
situations involving potential imminent hazard,
unreasonable risks, or substantial endangerment
to health or the environment.*
Violations of TSCA § 8(d) and 8(e) involving
human data.
Violations of TSCA §8(e) involving Information
on emergency incidents of environmental contam—
ination (EIEC).
All Circumstance Level 2 violations.
All Circumstance Level 6 violations.
SIGNIFICANT Violations of TSCA § 8(d) and 8(e) involving
animal/aquatic studies, environmental monitor-
ing, workplace monitoring (not invasive human
monitoring), and any other study not addressed
in the major or minor extent level.
Violations of CAIR, PAIR, TSCA §8(a) chemical
specific rules, TSCA §8(c), Inventory, and
Inventory Update Rule except Level 2 or Level
6 violations.
Violations of TSCA §12.
Violations of TSCA §13.
MINOR Violations of TSCA §8(d) involving physical/
chemical properties or environmental fate data.
* This determination must have written concurrence from OPTS.

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—12—
Per Day Assessments
Where per day assessments are provided for in the Circum-
stances Level section, the base penalty is calculated for
the first day of violation and per day penalties are assessed
for each subsequent day of violation based on the following
formula:
Violations Involving Potential Imminent Hazard/Substantial
Endangerment Si tuati ons/Un reasonable RI sks
Base X Each day of violation = Penalty
Penalty
TSCA §8(e )
Base + ( No. of days of violation — 1) x base penalty = Penalty
Penalty 30
TSCA §8(a) Chemical Specific _(
Base + ( No. of days of violation — 1) x base penalty = Penalty*
Penalty 360
All others
Base + ( No. of days of violation — 1) x base penalty = Penalty*
Penalty 180
* The number of days of violation cannot exceed caps as
designated in the following section.
Caps on Number of Days for Penalty to be Assessed Per Violation
TSCA §8(e) No cap
TSCA §8(d) 5 year cap Major Extent Violations
3 year cap Significant Extent Violations
1 year cap Minor Extent Violations
ISCA §8(c) 1 year cap
TSCA §8(a) 1 year cap
Chemical
Spec i fic
PAIR 1 year cap
CAIR 1 year cap

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—13—
Determining Number of Violations —
Multiple penalties are to be used if there is more than
one violation of the same rule or violations of different rules.
Violations will be determined as follows:
ISCA §8(a)
ISCA §8(a)
TSCA §8(a)
TSCA §8(a)
TSCA §8(a)
Rules
Inventory
Inventory Update
PAIR
CAIR
Chemical Specific
Per Chemical
Per Chemical Per Site
Per Chemical Per Site
Per Chemical Per Site
Per Chemical (Per Chemi-
cal Per Site if Site—Spe-
cific Reporting Is Re—
qul red)
Per Allegation Submitted
to Company and Not Filed
Per Requirement Not Met
Per Firm
Per Allegation Not Reported
Per Study Per Chemical
Per Type of Reportable
Effect or Event Per
Chemica
1
TSCA §8(c) Failure to Keep
Records
TSCA §8(c) Failure to Keep
Records as Required
TSCA §8(c) Report
TSCA §8(d)
TSCA §8(e)
TSCA
§12
Per
Chemical
Per
Coun-
try
Per Year
TSCA
§13
Per
Shipment
Per
Port

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Determining the Gravity Based Penalty
The circumstances level and the extent category for each
violation will define a base penalty in the matrix. For those
violations designated as per day in the circumstances matrix,
calculate the penalty as indicated under per day assessnents,
taking into account the caps on the number of days the penalty
is to be assessed. This total penalty should be entered on line
1 of the TSCA Civil Penalty Assessment worksheet and adjusted
by the appropriate factors discussed in the TSCA Civil Penalty
System and this policy.
Adjustment Factors
The TSCA Civil Penalty System discusses appropriate adjust-
ment factors. In addition, adjustment factors specific to this
policy are discussed below.
Voluntary Disclosure (Other Factors as Justice May Require )
The ERP establishes fixed percentage reductions in penal-
ties for voluntary disclosure of violations for the following
sections only: TSCA §8(a) Inventory Rule, TSCA §12, and TSCA
§13. For all other sections, the voluntary disclosure of a
violation is to be treated as a late report, and therefore,
the violator receives a substantial reduction since the
circumstance level moves from Level 1 to Level 4.
For TSCA § 8(a) Inventory Rule, 12 and 13, the adjustment
factors for voluntary disclosure Is as follows:
Disclosure . ............................ 25%
Immediate disclosure within
3Odays of discovery ...................25%
TOTAL 50%
The Agency will not consider disclosure voluntary if the
company has been notified of a scheduled inspection or the
inspection has begun. Information received after these
events will be considered as failure to report/file.
However, if, for example, an inspector is conducting a TSCA
§8 inspection at an establishment, and the company voluntarily
discloses a TSCA §13 violation and the inspector would not
have any expectation of discovering such a violation, the TSCA
§13 violation would be considered to be voluntarily disclosed.
This example would also apply to TSCA §12 violatIons. For
TSCA §12 and §13 violations, if a company discloses addi-
tional violations during or prior to settlement negotiations,
those violations are eligible for voluntary disclosure reduc-
tions. The Region may deal with this situation through:

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-15—
1) an amendment to the original complaint; 2) an additional
complaint; or 3) addressing additional charges in the Consent
Agreement and Final Order.
Economic Benefit
In no case should the final penalty imposed be less than
th.e economic benefit. In those cases where the initial penalty
is less than the economic benefit derived from noncompliance,
EPA reserves the right to impose per day penalties up to
$25,000 per day to assure that the penalty is not less than
the economic benefit.
Exposure Reduction (Other Factors as Justice May Require )
In cases warranting per day assessments of the base penalty,
i.e., those involving potential imminent hazard, etc., if the
— Respondent has credible evidence by affidavit which shows, for
example, exposure has ceased by all routes of exposure, environ-
mental and/or commercial; that evidence may be considered to
mitigate the penalty. In those cases, the penalty will be as-
sessed at the maximum base penalty per day during the duration
of the exposure presenting Imminent hazard/substantial endanger-
ment/unreasonable risk and assessed as a violation not presenting
the potential hazard/risk/endangerment during the time that
the hazard/risk/endangerment had ceased to exist.
Attitude
For TSCA §13 violations, if the company had a system in
place to track import certifications and comply with TSCA
§13 requirements, and a chemical “slips through”, a 15% good
attitude reduction may be given as provided for in the ISCA
Penalty Policy. Larger reductions are inappropriate in that
companies are required to comply with certification require-
ments and credit should not be given for attempting to comply
with the law. If a company experiences numerous occasions
where chemicals uslip through” their system, a good attitude
reduction Is no longer appropriate.
History of Previous Violation
The Agency will disregard the . firm’s prior history of
violations in calculating the penalty for a self-disclosed
violation. However, for violations discovered by the Agency,
the Agency will address history of prior violations as indi-
cated in the TSCA Penalty Policy, even If the prior history
results from a violation which was voluntarily disclosed.

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-16-
Explanation of the Penalty Policy
Nature _________ _________________
TSCA § 8 and 12 require that information concerning
chemicals be reported to EPA or kept at the company and made
available to the Agency. TSCA 13 requires importers to certi-
fy that chemicals imported are either not subject to TSCA or
are in compliance with TSCA.
Section 8 informatIon is used by the Agency to evaluate the
potential risks associated with the manufacture and use of a
chemical. This data gathering often occurs at the early stages
of regulatory decision making. Therefore, complete and accurate
information is essential. Incomplete and inaccurate information
will have far—reaching effects on the Agency’s risk assessment,
regulatory priority setting, and regulation development processes.
Some information Such as TSCA §8(e) information may affect the
Agency’s ability to init tate immediate action necessary to pro-
tect health and the environment, e.g., seeking injunctive relief.
In addition, reports under the original Inventory Reporting Rule
establish the basis for what is an “existing” chemical versus
a “new” chemical, the latter being those for which a premanu—
facture notice must be filed and the chemical reviewed by the
Age n cy.
Section 12 collects information about the export of chemicals
subject to certain proposed or final testing or regulatory require-
ments under TSCA § 4, 5, 6, or 7. The Agency provides this infor-
mation to the government of an importing country to allow that
country to initiate its own risk assessment process.
The section 13 rule describes procedures for certifying that
Imported chemical substances subject to TSCA are In compliance
with TSCA. This information permits the Agency to determine if
importers of chemicals are complying with applicable TSCA regula—
ti ons.
Circumstances
The circumstances axis of the GBP matrix reflects the
probability for harm resulting from a particular violaton.
For the reporting rules, the potential harm caused is the harm
to the Agency’s regulatory program for controlling health and
environmental risk. For violations of the original Inventory
Reporting Rule, the potential harm is that a new chemical may
be produced with no prior review contrary to the Intent of
TSCA because an Inventory Rule violation resulted in a chemical
being placed on the Inventory which was not an “existing” chem-
ical under TSCA. For chemicals which other persons also reported,
the harm deals with the information on the estimated produc-
tion volume and sites of manufacture which the Agency uses In
its risk assessments, Including those for TSCA §4 test rule
decisions. For section 12 reportIng, the potential harm is

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—17—
to the Agency’s ability to carry out its responsibility to
notify other countries. Thus, violations have the potential
to also harm another country’s regulatory program.
High Range Violations — Level 1
Nonreporting/failure to report or to keep records is an
extremely serious violation of these rules. The Agency will have
to proceed with chemical assessment and priority setting, and
perhaps, even regulation development, especially for TSCA §4
test rules, without critical information or without the knowledge
that such informaton even exists. This is true even if a company
reports some information but does not report each study or under—
reports the extent of health effects or number of allegations for
a particular effect. Thus, each report omitted or incompletely
reported will be treated as a separate nonreporting violation.
False/incorrect/misleading reporting of information is
equal iy harmful because the Agency is misled in its analysis of
the potential risks posed by the chemical or in the amounts or
types of information available.
TSCA §8(c) violations in level 1 include failure to keep
records and failure to report if the Agency has requested that
the information be submitted. Thus, if a company has received
TSCA §8(c) allegations, but does not maintain TSCA §8(c) records,
and the Agency requests that TSCA §8(c) allegations be submitted
and the company fails to make a submission, there are two viola-.
tions - one for the failure to keep records and another for the
failure to report. Even if a company submits most allegations
but not all, each failure to submit an allegation shall be
separately charged and assessed as a failure to report.
TSCA §8(d) level 1 violations include the following:
— Failure to submit unpublished studies in the
manufacturer’s, importer’s or processor’s
possessi on.
— Failure to notify EPA of unpublished studies
the manufacturer, Importer or processor
knows of but is not in possession of.
- Failure to notify EPA of ongoing studies which
the manufacturer, Importer or processor
Initiated or sponsored. Includes future studies
required to be reported once they are initiated.
— Failure to send EPA the final report of a
study which was listed as an ongoing study.
Includes future studies required to be
submitted.

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— Failure to submit underlying data to EPA on
EPASS request.
Failure to comply with the TS(A §8(e) repnrting requirements
is potentially the most serious violation of TSCA §8. TSCA §8(e)
reports alert the Agency to new information which may have a
hearing on the Agency’s regulatory efforts. This ERP reflects
th seriousness the Agency attaches to violations of TSCA §8(e)
by placing no caps on the penalties assessed for these violations.
High Range Violations — Level 2
Failure to maintain records or report in a manner that meets
the standard required by the rule has effects similar to falsi-
fied information. Both mislead the Agency nd are difficult to
detect. Failure to report in a manner that meets the standard
refers to those cases where reporting is essentially complete
and the missing/incorrect information does not impact the
report in such a manner as to mislead the Agency. An example
is the failure to report one ongoing TSCA §8(d) study when
another similar study is reported by the company. Another
example is a small error in reporting production volume, i.e.,
less than an order of magnitude (a factor of 10).
Level 2 also includes a TSCA §8(d) violation involving
the failure to report a study which a manufacturer knows of
but which is not in his possession. The Agency considers this
violation to have less potential harm than other failure to report
violations since the Agency is likely to learn of this study from
other persons reporting.
Mid Range Violations - Level 3
Failure to report completely after EPA has requested missing
information is a significant violation. Such a violation denies
the Agency access to information necessary to its analysis of
chemical risks. This type of violaton is not as serious as the
high range violations because It is usually relatively easy to
detect and therefore easy to remedy. A form, for instance, will
have blank spaces where answers are expected. Even though the
Agency does not have the information, it knows that an information
gap exists, and therefore, is less likely to be misled into making
invalid chemical risk assessments. However, the withholding of
information is a serious Impediment to risk assessment, and if
it becomes a widespread practice, It could significantly affect
the Agency’s chemical risk assessment processes. Thus, this vio-
lation, while not as serious as a total failure to report or
false or misleading reporting, is still of sufficient severity
to be treated in the higher level of the midrange.

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For ISCA §8(c) files, the failure to maintain reports
as required in the rule, e.g., files which are present but which
are not cross—indexed or which are not kept in one location, in-
volves a level 3 violation. in those cases where the company files
this information, and the Agency requests the information to be
submitted, and information is not submitted because the company’s
files result in the information not being discovered during the
company’s file search, the failure to submit is a level I viola-
tion. The company may also be charged with the level 3 violation.
Please note that failure to file an allegation under TSCA §8(c)
although other allegations are filed constitutes a level 1
failure to keep records violation.
Another level 3 violation involves TSCA §13 violations
where there is a positive/negative/no certification and the
chemical is in violation of other TSCA provisions. TSCA §13
is designed to assure that an importer takes affirmative responsi-
bility in assuring that his shipments comply with TSCA. Where
other TSCA violations are found, a level 3 violation will be
assessed plus appropriate penalties for the other TSCA violations.
Mid Range Violations - level 4
Reports which are late can significantly slow or disrupt the
Agency’s decision making process. The exact timing nay vary on a
rule by rule bas1 which will be discussed In the Compliance
Monitoring Strategies. lateness is classified In the lower level
of the midrange circumstances category.
in addition, the Agency has decided to treat reports which
are submitted late as late reporting regardless of the date
of submission, with the exception of reports for the original
Inventory Rule and TSCA § 12 and 13. This decision has been
made to encourage the voluntary disclosure of violations by
assessing penalties as level 4 Instead of level 1. For the
original Inventory Rule and ISCA § 12 and 13, a reduction is
provided for the voluntary disclosure of violations. Reports
submitted or violations disclosed after EPA has notified a
company of a scheduled Inspection will be treated as level 1
failure to report violations, except as otherwise Indicated
in the Summary of the Penalty Policy.
TSCA §12 violations other than the first violation are
categorized as level 4. The Agency considers TSCA §12 report-
ing to be important to its ability to notify other countries
to which chemicals subject to TSCA rulemaking are being exported.
The potential harm Is not to the Agency’s decision making process
but to its statutory obligation to notify other countries.

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The Agency considers TSCA §13 violations, other than the
first TSCA §13 violation for which there are no other TSCA viola-
tions, to be mid range level 4 violations. Even if no actual
harm occurs, the violation reflects the importer’s failure to
assure full compliance with TSCA. Failure to certify or filing
a false certification on each shipment circumvents the purpose
of TSCA §13 and could lead to the importation of chemicals
which violate other provisions of TSCA.
Low Range Violations - Level 6
There are no violations which fall within level 5. level 6
violations include minor technical omissions which do not affect
the Agency’s ability to follow up the information either by
contacting someone in the company or consulting outside references.
They are among the least serious because the violation is readily
detected, does not affect initial risk assessment and may only
slightly hinder the Agency’s decision making process. In
cases where there is no effect on the Agency, a notice of non-
compliance rather than a penalty may he appropriate. However,
if a company repeats this type of violation, the Agency will
assess a penalty.
Another level 6 violation is the failure on the part of a
manufacturer to keep records showing that he Is not subject to
reporting under the TSCA §8(a) Inventory Updat Rule, which
requires persons who produce less than 10,000 lbs. of a sub-
stance to maintain records documenting that fact.
Other low range violations include a submission of TSCA
§8 information which is not identified as TSCA §8(_)
information and which is not sent to the correct office.
Also, submitting the information to the incorrect office or
not correctly identifying the information after a previous
Notice of Noncompliance has been issued for a violation of
that section warrants a level 6 assessment. Although the
Agency receives the information, it may take some time to reach
the correct office or to be placed into the review process,
and therefore, the Agency’s decision making is delayed or
impeded.
Extent
This factor reflects the extent of potential harm to
EPA’s hazard/risk assessment process. The Agency relies
on information gathered under sections 8(a), 8(c), 8(d),
and 8(e) to perform risk assessments. The Agency uses
TSCA § 12 and 13 in a different way. TSCA §12 information is
used in order to notify foreign governments. ISCA §13 is used
to assure that Importers verify and certify compliance with
TSCA.

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—21—
For risk assessment, information may be related to toxi-
city or exposure, both important in determining risk. In
examining the extent of potential harm, the type of information
•is important, i.e., human effects data, human exposure data,
animal data, environmental effects, actual environmental con-
tamination information. Also, scientific studies versus
allegations differ in their importance.
Major Extent
Violations which directly interfere with the Agency’s
ability to address potential imminent hazard, unreasonable
risk, or substantial endangerment to health/environment are
placed in the major extent category. This criteria is appli-
cable to TSCA 8(c), 8(d), and 8(e). Examples of these types
of violations include: 1) information on injury to humans
where continued manufacture or use poses a potential imminent
hazard; or 2) information on a spill/dumping which is covered
by TSCA §8(e) and which posed(s) an imminent hazard or results
in widespread environmental contamination to which persons.
exhibit serious health effects. In the second case, two
violations would be charged, one for the failure to report
the spill and another for the failure to report the health
effects.
Other major extent categories include TSCA § 8(d) and 8(e)
violations involving information on human effects. Such infor-
mation can weigh heavily in the Agency’s decision making
process.
Also, violations involving emergency incidents of environ-
mental contamination reportable under. TSCA §8(e) are considered
to be of major extent since the Agency needs such Information
immediately. Otherwise, the opportunity to. provide adequate
protection may be lost.
All level 2 and level 6 violations are placed in the major
extent category.
Significant
The Agency places slightly less importance on animal studies
as opposed to data reporting effects in humans. Nonetheless,
such information is critical to the Agency’s decision making
process. Such tests may be expensive, may take a long time to

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—22-
conduct, and require rulemaking by the Agency to obtain them.
For example, if a company fails to report a study it has, the
Agency may decide that such data are needed and proceed to do
unnecessary rulemaking under TSCA §4. Given the time for such
rulemaking and the time needed to conduct tests and submit re-
sults to the Agency, the violation results in a major delay in
the Agency’s risk assessment of the chemical and an unnecessary
expenditure in resources, both EPA’s and industry’s. Please
note that failure to report a study which is required to be re-
ported but which indicates no adverse effects of the chemical
still results in this harm.
The Agency has also decided to place violations involving
exposure related data in the significant category when the
EPA has made a decision that it needs such information for
a specific chemical. Thus, TSCA § 8(d) and 8(e) violations
involving exposure related information as well as violations
of the CAIR, PAIR, and TSCA §8(a) chemical specific rules,-
all of which involve exposure related information, are consid-
ered to be significant category violations. Although exposure
information is critical to any risk assessment, the impact on
the Ageny’s decision making if one company fails to report and
all other companies comply is less than if one company fails
to submit a toxicity study since It is less likely that another
company will submit the same study. This distinction is
reflected in the establishment of caps for different types of
violations.
TSCA §8(c) involves allegations and not actual test data.
However, such information is important to the Agency’s decision
making process in that it Involves patterns of effects and
generally involves human effects. Therefore, these violations
are categorized as significant.
TSCA §8(a) Inventory and Inventory Update Rules are also
designated as significant. Although information under these
rules is not required as a result of the Agency Identifying
a specific need for information on specific chemicals, this
information provides exposure related information which is
important to the overall decision making of the Agency in terms
of setting its priorities and deciding what rulemaking to
pursue.
TSCA §12 violations are also considered significant since
such information is necessary for EPA to carry out its responsi-
bility to notify other countries of chemicals for which EPA
has taken certain actions, i.e., a TSCA §5 order or a final or
proposed TSCA § 4, 5 or 6 rule. TSCA §13 is significant in
that violations hinder EPA/Customs’ ability to monitor ship-
ments for compliance with TSCA.

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-23-
Minor
Two types of violations fall into the r’iinor extent level,
i. ., violations of TSCA §R(d) involvinq physical/chemical
properti s r environmental fate data; and violations of TSCA
§8(a), failure tn keep records showing that a manufacturer is
not suhject to reporting under the Inventory Update Rule.
The ISCA §8(d) violations are categorized as minor based on
the relatively low costs of such studies and the time it takes
for the study to be conducted. The TSCA §8(a) violations are
easy to detect upon inspection and information the company
should already have.
Per Day Penalties or One Day Assessments
The Agency has elected to use one day assessments for
violations of rules which require reporting for all chemicals
meeting certain criteria (such as exceeding a given production
volume per site) as opposed to information which is not being
requested on a chemical specific basis. In other words, one
day assessments are appropriate in cases where the Agency uses
the information to set priorities and may use it as the need
arises on a specific chemical evaluation but has not affirma-
tively identified a particular chemical for which specific
information is needed.
In those cases where EPA has issued a rule which lists a
specific chemical(s), per day assessments are appropriate because
the Agency has identified a need for the information for risk
identification, risk assessment, or risk management purposes.
Per day assessments also apply to any TSCA §8(e) information
(except ETEC’s which do not meet the potential imminent hazard/
endangerment criteria). Although the information is not being
requested for a specific chemical, it is likely to be used
immediately for risk assessment purposes. Per day assessments
are made for those violations where the continuing violation
continues to impede the Agency’s decision making process.
One day assessment is appropriate for a failure to list a
TSCA §8(d) study which a company knows of but which is not in
Its possession. Level 2 and level 6 vIolations are to be as-
sessed as one day. Also, TSCA § 12 and 13 are considered to
be one day violations. As with TSCA §8(e) violations dealing
with an EIEC, violations of these rules do not impede the
Agency’s regulatory decision making process in that such infor-
mation would not normally result In rulemaking. However, such
information is necessary for more immediate actions such as
Injunctive relief or seizing chemicals which are otherwise in
violation of ISCA, e.g., a TSCA §13 chemical imported in viola-
tion of TSCA §5.
Violations Involving TSCA §8(c) fIles, i.e., failure to
record information, are treated as one day violations because
the effect on the Agency’s decision making is not critical

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-24-
until the Agency requests the submission of TSCA §8(c) informa-
tion. Once the information is requested, the Agency has a
specific need for the information to make its decisions. There-
fore, “failure to report” violations under TSCA §8(c) are as-
sessed on a per day basis due to their adverse impact on the
Agency’s decision making.
Per Day Assessment Calculation
For violations involving ISCA §8(e) information which directly
interferes with the Agency’s ability to address situations in-
volving potential imminent hazard, unreasonable risk, or substan-
tial endangerment to health/environment, the base penalty is to
be assessed for each day of violation. These are the most serious
violations, and therefore, warrant the highest penalties provided
for by the statute.
For other TSCA §8(e) violations, the base penalty is to be
used for the first day of violation. For each day thereafter,
the per day penalty is the base penalty divided by 30. This ad-
justment was selected for the following reasons: 1) these viola-
tions involve significant adverse effects; 2) the Agency has an
immediate need for the information in order to protect the pub-
lic and environment, as reflected in the statute’s language to
“immediately notify”; and 3) the timing of the Agency’s decision
making process once such data is received.
For TSCA § 8(c) and (d) violations for which per day assess-
ments are to be made, the base penalty is to be used for the first
day of violation and for each day thereafter, the per day penalty
is the base penalty divided by 180. For TSCA §8(a) Chemical Spe-
cific violations the per day penalty is the base penalty divided
by 360. ThIs method was selected in order to provide further
distinction between types of violations and their impact on the
Agency’s decison making process and its mission to protect the
public and the environment.
Caps
In establishing caps for some violations, the Agency took
into account factors such as the length of time that a violation
continues, the timing of the Agency’s decision making process,
the relative costs of studies and the length of time needed if
unnecessary studies .are conducted. Please note that the cap
does not refer to a limitation on the time elapsed since the
violation occurred — only a limit on the number of days for
which a penalty Is assessed even though a violation continues
for a longer period.
There Is no cap on TSCA §8(e) violatIons. The harm
continues as long as the violation continues.
For TSCA §8(d) studIes, which often relate directly to
TSCA §4 rulemaking, the caps depend on the type of study, the
length of time to conduct the study, the relative costs of the
studies, and the timing of the Agency’s decision making.

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-25-
For other TSCA §8 violations for which per day assessments
are to be made, a one year cap is set based on the estimated
time of the Agency’s decision makiny process. This decision
also reflects the fact that TSCA §8(a) requirements are more
exposure on ented than toxicity oriented, and therefore, the
quality of the information is sensitive to time. As indicated
in the discussion on extent categories, exposure information
is important but one company’s failure to report may not have
as much of an impact as nonreporting of toxicity information
because the exposure information is used in the context of total
exposure. Therefore, these violations are capped at one year.
A chart is provided in Appendix I which indicates the caps
per violation and their maximum assessments. Caps refer to
maximum penalties for each separate violation; they are not
cumulative caps for multiple violations.
Determining Number of Violations
The number of violations depends on the requirements which
are in each rule. Multiple violations are to be assessed when-
ever more than one rule is violated and for each violation within
a rule. TSCA §8(a) Inventory violations are assessed for each
chemical for which there is a violation. The Inventory Update
rule requires reporting for each chemical and for each site.
Therefore, TSCA §8(a) Inventory Update violations are assessed
per chemical per site.
Violations of CAIR and PAIR are assessed per chemical per
site. TSCA §8(a) Chemical Specific Rules violations depend
on the information required by the rule. If the rule requires
site specific information, then violations are assessed per
chemical per site. If the rule requires aggregate information
for each company, then violations are assessed for each chemical
not reported/otherwise in violation.
TSCA §8(c) violations are determined depending on the viola-
tion. TSCA 58(c) “failure to keep records” violations and “failure
to report” violations are assessed per allegation not malntained/
reported. This is because the omission of any allegation may
impact the Agency’s decision making process, especially If there
is significant underreporting of allegations. However, a “failure
to keep records as required” under TSCA §8(c) is assessed per plant
site because these violations involve files not maintained as
prescribed but for which the information is available. An alle-
gation consists of each report (i.e., one or more pieces of paper)
whereby an Individual! group submits an allegation to a company.
If one person alleges that six chemicals produced ten effects
In the same report, and the company fails to file the allegation,
this is assessed as one violation. If two persons file separate
reports regarding the same health effect, and the company does
not file the allegations, this constitutes two violations. If

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-26-
a union files a report for 100 persons regarding an allegation,
and the company does not fi1e the allegation, this is assessed
as one violation.
• TSCA §8(d) violations are assessed for each required study.
The omission of a single study even if others are submitted may
have a serious impact on the Agency’s decisions regarding a
specific chemical. TSCA §8(e) violations are assessed per type
of effect per chemical not reported. Omission of one significant
adverse effect even if other effects are reported impedes the
Agency’s risk assessment.
TSCA §12 violations are assessed per chemical per country
per year not reported. This decision was based on the determina-
tion that the export notification requirement Is a one-time
requl rement per year for each chemical and for each country of
export. That is, the first time a chemical is exported to a
country, the exporter must notify the country. Subsequent
exports of the same chemical during the same calendar year to
the same country do not require notification.
TSCA §13 violatIons are assessed per shipment per port
because the u .S. Customs regulation requires a certification for
each shipment, not for each chemical within a shipment. If the
same chemical is imported on the same day to a port in three
separate shipments, there are three violations.
Adjustment Factors
Voluntary Disclosure
The Agency considers It important to foster voluntary
disclosures of violations for TSCA § 8, 12, and 13. Most dis-
closures of TSCA §8 violations will be treated as late reporting
and subject to level 4 instead of level 1 penalty assessments,
which provides a voluntary disclosure incentive. For TSCA §8(a)
Inventory violations and TSCA § 12 and 13 violations, explicit
reductions for voluntary disclosure are also provided. It is
important to foster voluntary disclosure of TSCA §8(a) Inventory
violations in order to remove chemicals from the Inventory which
were placed there illegally. Once the Agency knows of this, It
it can act to correct the violation. Similarly, if violations
of TSCA § 12 and 13 are brought to the Agency’s attention, it
can act to remedy the situation, e.g., foreign countries can
be notified or imports in violation of other sections of ISCA
can be identified and appropriate action taken.
Also, EPA wants to encourage companies to conduct self-
audits and report violations.

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—27—
History of Noncompliance — ___
As a further incentive for the voluntary disclosure of
violations, the Agency has decided to forego the imposition of
penalty increases for a previous history of noncompliance in
assessing penalties for voluntarily disclosed violations.
However, a voluntarily disclosed violation does constitute
a history of violation and is to be used to increase penalties
for future violations which the Agency discovers.
TSCA Section 13 — Who Issues Notice of Noncompliance/Penalty
and to Whom
TSCA §13 may involve imports in one Region by an importer
of record, who is located in another Region and who uses a
broker. The Notice of Noncompliance/Penalty is to be issued
to the importer of record, not the broker, and by the Region
in which the importer of record is located. This is consistent
with the Inspection Guidelines.
This decision was made for several reasons. If a TSCA §5
inspection is conducted at the importer of recordss business,
and there Is a chemical which has been Imported into three ports
In three other Regions and which Is not on the inventory, it is
more efficient to Issue a Civil Conplaint for the one TSCA §5
vio’ation and three TSCA §13 violations than to issue four sep-
arate Civil Complaints in four Regions.
A second reason pertains to the location of the hearing.
If one Region issues the complaint to an importer of record in
another Region, there is a problem of travel , both in terms of
time and money, since the hearing will likely be held in the
Region where the importer of record is located.
A third reason deals with the tracking of Notices of Non-
compliance between Regions in order to know if a company has
received its first TSCA §13 Notice of Noncompliance and Is
therefore subject to penalties for subsequent violations.

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APPENDIX 1
CAPS FOR PER DAY VIOLATIONS

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CAPS FOR PER DAY VIOLATIONS
ALL CAPS ARE PER VIOLATION
TSCA §8(e ) - No Caps
TSCA §8(d )
Nonreporting/Fal
Major, level
Sign I ficant,
Minor, level
Late Reporting
Major, level
Significant,
Minor, 1 eve1
se Reporting
1 —
level 1 —
1 —
4
level 4
4
$278,333 - 5 yr. cap
$120,322 — 3 yr. cap
$15,111 — 1 yr. cap
$111,333 — 5 yr. cap
$42,467 — 3 yr. cap
$3,022 — 1 yr. cap
TSCA 8(c )
Nonreporting/False Reporting
Significant, level 1 —
Late Reporting - 1 yr. cap
Significant, level 4 —
— 1 yr. cap
$51 ,378
$18,133
TSCA §8(a) Chemical Specific rules
Nonreporting/False Reporting
Significant, level 1 —
Late ReportIng— 1 yr. cap
Significant, level 4 —
— 1 yr. cap
$34,189
$12,067

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APPENDIX 2
EXAMPLES

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EXAMPLES
TSCA §8(a) Chemical Specific Rules (PAIR, CAIR, Asbestos, etc. )
Example 1 — A company fails to report. EPA discovers the
violation. Failure to report, level 1, significant.
Discovered after 181 days - $25,500
$17,000 + 180 X $17,000 = $25,500
360
Discovered after 361 days - $34,000
Discovered after 1,095 days — $34,189 (1 yr. cap)
Example 2 - A company reports late. Late report, level 4,
significant.
Report 181 days late — $9,000
$6,000 + 180 X $6,000 = $9,000
360
Report 271 days late - $10,500
Report 730 days late - $12,067 (1 yr. cap)
Example 3 — A company reports under the rule. EPA later
discovers that the Information was falsely reported.
False reporting, level 1, signifIcant.
Discovered after 181 days — $25,500
$17,000 + 180 X $17,000 = $25,500
360
Discovered after 361 days - $34,000
Discovered after 1,095 days - $34,189 (1 yr. cap)
Example 4 - A company reports under the rule. The company
later reports that some of the information was inaccurately
reported and supplies EPA with the correct information
• within 10 days. Late reporting, level 4, significant.
Reported 181 days late — $9,000
$6,000 + 180 X $6,000 = $9,000
360
Reported 365 days late - $12,067
Reported 1,825 days late — $12,067 (1 yr. cap)

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—2—
TSCA §8(a) Inventory and Inventory Update
Example 1 — A company fails to report a chemical on the
TSCA Inventory. EPA discovers the violation. Failure
to report, level 1, significant, one—time penalty.
Failure to report — $17,000
Example 2 — A company fails to report a chemical on the
TSCA Inventory. The company is bought by another company
who, upon checking records, discovers the failure to report
and immediately notifies the Agency. Failure to report,
level 1, significant, one—time penalty.
Failure to report - $17,000
Voluntary Disclosure Policy — 50% reduction of penalty.
Amended Penalty - $8,500
Example 3 - A company falls to report 1 chemical at 4 dif-
ferent sites for the Inventory Update. The company is bought
by another company who, upon checking records, discovers the
failure to report and immediately notifies the Agency. Late
reporting, level 4, significant, 4 counts, one—time penalty.
Late reporting, 4 counts - $24,000
TSCA §8(c )
Example 1 — A union contacts EPA complaining that they
submitted 1 report to the company regarding health effects
to 10 workers due to their exposure to chemical X. The
report was presented to the company In accordance with the
rule, and the union provided acknowledgments of receipt by
the company. EPA requested the company to provide all
allegations of health effects due to exposure to chemical
X. The company failed to respond. EPA inspected the com-
pany’s TSCA §8(c) fIles six months later and found none.
Failure to keep flies, level 1, sIgnificant; and failure to
report, level 1, significant.
$17,000 + $17,000 + 180 X $17,000 = $51,000
180
Failure to maintain a file $17,000
Failure to report (per day penalty) $34,000
181 days ________
Total 51,000

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-3—
Example 2 - EPA requested a company to submit any al-
legations of effects attributable to chemical V. The
company reported that no allegations of effects of any
kind were made to them. An inspector visited the com-
pany 2 years later and found a file for chemical V which
included 3 allegations of bird kills attributed to the
chemical. Failure to report, level 1. significant, 3
counts.
$17,000 + 364 X $17,000 x 3 = $154,134
180
Failure to report - (1 yr. cap) — $154,134
Example 3 — EPA requested a company to submit any al-
legations of effects attributable to chemical V. The
company reported that no allegations of effects of any
kind were made to them. A year later they contacted the
Agency and informed us that they just found 4 old al-
legations of human effects attributable to chemical V
and submitted the allegations within 10 days. Late
submission, level 4, significant, 4 counts.
$6,000 + 360 X $6,000 x 4 = $72,000
180
Late reporting — 361 days x 4 - $72,000
Example 4 — An Inspector visited a company and asked to
see the company’s TSCA §8(c) files. The company informed
the inspector that any allegations by workers were kept
in the Individual workers personnel files. Failure to
keep files in a manner prescribed by the rule, level 3,
significant, one day assessment, no per day penalty. $10,000
Example 5 — An inspector visits a company and when inspecting
their TSCA §8(c) file discovers that the files are organ-
ized by the health effect rather than by the cause of the
health effect. The files are otherwise in compliance with the
rule. Failure to keep files in a manner prescribed in the
rule, level 3, signIficant, one day penalty. $10,000

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-4 —
TSCA §8(d )
Example 1 — A company submits a list of ongoing studies they
are sponsoring but fails to list a study involving humans.
EPA discovers the violation. Failure to report, level 1,
major.
Discovered after 365 days — $75,556
$25,000 + 364 X $25,000 = $75,556
180
Discovered after 1,095 days — $176,944
Discovered after 2,000 days — $278,333 (5 yr. cap)
Example 2 — A company submits late an animal study in the
company’s possession during the initial reporting period.
Late reporting, level 4, significant.
Reported to EPA after 365 days — $18,133
$6,000 + 364 X $6,000 = $18,133
180
Reported to EPA after i,095 days - $42,467
Reported to EPA after 1,825 days — $42,467 (3 yr. cap)
Example 3 - A company submits an animal study, EPA finds ad-
ditional reportable information that the company intentionally
omitted from the submitted study report. False reporting,
level 1, significant.
Discovered after 365 days - $51,378
$17,000 + 364 X $17,000 = $51,378
lop
Discovered after 1,095 days — $120,322
Discovered after 1,825 days — $120,322 (3 yr. cap)
Example 4 — A company submits a list of 9 ongoIng animal
studies and later submits 10 studies. Late reporting of one
study, level 4, signifIcant.
Submitted to EPA 365 days after list submitted — $18,133
$6,000 + 364 X $6,000 = $18,133
180
Submitted to EPA 1,095 days after list submitted — $42,467
Submitted to EPA 1,825 days after list submitted — $42,467
(3 yr. cap)

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—5—
Example 5 — A company submits a list of studies known to
them but not in their possession. The Agency discovers that
the company failed to list a study they had knowledge of.
Failure to report a study the manufacturer knows of but is
not in his possession, level 2, major, one day assessment,
no per day penalty. $20,000
CA §8(e )
Example 1 - A company failed to report a spill within the
time period prescribed in the policy. EPA discovers the
violation. Failure to report, level 1, major, one—time
assessment — $25,000
Example 2 - A. company failed to report a spill within the
time period prescribed in the policy. The company reports
their failure to EPA a year after the spill occurs. Late
reporting, level 4, major, one—time assessment — $10,000
Example 3 — A company fails to report a study showing human
health effects. EPA discovers the violation. Failure to
report, level 1, major.
Discovered after 361 days — $325,000
$25,000 + 360 X $25,000 = $325,000
30
Discovered after 1,081 days - $925,000
Discovered after 3,601 days - $3,025,000
Example 4 — A company fails to report a study showing animal
effects not previously reported. The company later submits
it to the Agency. Late reporting, level 4, significant.
Reported after 361 days - $78,000
$6,000 + 360 X $6,000 = $78,000
30•
Reported after 1,081 days — $222,000
Reported after 3,601 days - $726,000

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-6—
Example 5 — A company submits a study to EPA showing
new animal effects. An inspector conducting an inspec-
tion of the company later discovers reportable information
which was omitted from the study. False reporting, level
1, significant.
Discovered after 1,825 days — $1,050,600
$17,000 + 1,824 X $17,000 = $1,050,600
30
Discovered after 365 days — $223,267
Discovered after 3,650 days — $2,084,767
Example 6 — A company fails to submit human health effects
information which is later characterized by the Agency as
showing a potential imminent hazard. EPA discovers the
violation 90 days after the report was due. Failure to
report, level 1, major. Potential imminent hazard finding,
$25,000 per day penalty.
$25,000 X 90 = $2,250,000
EPA discovered the same violation after one year.
$25,000 x 365 = $9,125,000
EPA discovered the violation after one year and the company
presents credible evidence that exposure ceased after 90
days of the due date of the report. The penalty is calculated
as an imminent hazard for 90 days and as a reduced per day
for the TSCA §8(e) faIlure to report for the period thereafter.
$25,000 X 90 = $2,250,000
275 X $25,000 = $229,167
30
$2,250,000 + $229,167 = $2,479,167
TSCA §12
Example 1 — An exporter which has received no previous TSCA
§12 NotIce of Noncompliance exports 30 chemicals to 30 coun-
tries with no notifications. Failure to notify. Notice of
Noncompil ance.

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—7—
Example 2 — An exporter who has previously received a Notice
of Noncompl lance for a TSCA §12 violation exports one chemi cal
to one country 30 times during one calendar year with no
notifications. Failure to notify, level 4, significant. —
S6 ,000.
Example 3 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports one chemical
to one country 30 times during one calendar year, notifying
EPA that 5 shipments had already occurred. Failure to notify,
level 4, significant, voluntary disclosure, more than 30 days
since discovery, 25% reduction. - $4,500
Example 4 - An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports the same
chemical to 30 countries with no notifications within the
same year. Failure to notify, 30 counts, level 4, signifi-
cant. — $180,000
Example 5 — An exporter who has previously received a Notice
of Noncompliance for a TSCA §12 violation exports the same —
30 chemicals to 30 countries with no notifications within the
same year. Failure to notify, 900 counts, level 4, signifi-
cant. — $5,400,000
TSCA Section 13
Example 1 - Company imports a chemical with no certification
and which is otherwise in compliance with ISCA. Failure to
certify, level 4, significant.
First time violation: NON
Second time violation: $6,000
Example 2 — Second time violator imports a chemical which is
otherwise in compliance with ISCA at 3 ports on the same day
but has no certification or an incorrect certification.
Failure to notify, level 4, signifIcant, 3 counts — $18,000
Example 3: Second time violator imports 3 shipments of a
chemical which Is otherwise in compliance with TSCA on the
same day to the same port. Failure to notify, level 4,
significant, 3 counts — $18,000
Example 4 - Second time violator imports 30 shIpments which
are otherwise in compliance with TSCA but lack a certification.
Import may be to same port or different ports. Failure to
certify, level 4, signifIcant, 30 counts. $180,000

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0

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40 SP 4 p
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
‘I’, WASHINGTON, DC 20460
CERTIFIED MAIL
RETURN RECEIPT REQUESTED 7 89
TO C SU8STANCES
Mr. Blake A. Biles
Jones, Day, Reavis & POgue
1450 G Street, N.W.
Washington, D.C. 20005—2088
Dear Mr. Biles:
Re: Olin Runt Specialty Products, Inc.
This is in response to the meeting of March 29, and your
letter of April 3, 1989, requesting the granting of prosecutoria].
discretion for the continued commercial use of a chemical sub-
stance which may have been manufactured in violation of the Toxic
Substances Control Act (TSCA). In the meeting, you voluntarily
disclosed that Olin Hunt Specialty Products, Inc. had manufactur-
ed several chemical substances which were not listed on the TSCA
8(b) inventory. In addition, one chemical substance purchased
by Olin Hunt Specialty Products for research and development
purposes was used by Olin Hunt Specialty Products for nonresearch
and development purposes and incorporated into products used by
Sheldahi, Inc. in Orange County, California. This chemical is
subject to a low volume exemption request identified as L—89—82.
As you are aware, EPA will initiate a proceeding for the
assessment of a civil penalty against Olin Hunt Specialty
Products, Inc. for violations of TSCA involving the manufacture
and use of chemicals prior to their inclusion on the inventory.
Uoon review of this matter and the facts stated in your letter of
April 3, 1989 to Mary McDonnell, Office of Compliance Monitoring
and the letter of Timothy H. Butler of Lindquist & Vennum of
March 31, 1989 to Blake A. Bil .es, the facts of which we accept
as accurate and upon which we are basing our decision, EPA has
determined that the national interest would not be served by the
temporary discontinuation of Sheldahi’s use of the chemical
substance which is under review. The basis for this determina-
tion is that:
1. The chemical substance used by Sheldahl has received an
expedited risk assessment and was found not to present
an unreasonable risk of injury to human health and the
environment; and
2. The user of the chemical substance, Sheldahl, and its
employees may suffer an economic hardship due to a lack
of the chemical substance.

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—2—
Therefore from the date of this letter, Olin Hunt Specialty
Products, Inc. and Sheldahi, Inc. will, be authorized to use the
existing stocks of the chemical substance subject to the low
volume exemption notice. Commencement of any additional manufac-
ture may not resume until the low volume exemption review period
has expired. No civil penalty will be assessed for the use
of existing stocks of the chemical provided that each of the
following conditions are met:
1. Olin Hunt Specialty Products, Inc. initiates immediate
steps to ensure its compliance with TSCA and certifies
that all of its future manufacturing of these chemical,
substances is in full compliance with the provisions
of the Toxic Substances Control Act;
2. Within 30 days, Olin Hunt Specialty Products, Inc.
provides the Agency with all records pertaining to the
manufacture, processing, use, and export of chemical
substances in violation of TSCA as referenced in your
letter of April 3, 1989, including batch, sales, purchase,
and inventory records;
3. Within 30 days, Olin Hunt Specialty Products, Inc.
provides a narrative description of the steps required to
manufacture the chemical substances, the uses of the
chemical substances, and the structure and properties of
the chemical substances;
4. Within 30 days, Olin Specialty Products, Inc. provides a
complete written description of the events which led to
its dicovery of the violations and subsequent notification
of the Environmental Protection Agency (EPA);
5. Olin Hunt Specialty Products, Inc. promptly provides any
other documents or other information in the company’s
possession which the Agency seeks pursuant to Section 11
of TSCA in order to prepare a civil administrative case
for the violations of Section 15 of TSCA by Olin Hunt
Specialty Products, mc;
6. Olin Hunt Specialty Products does not contest the EPA’s
jurisdiction over the subject matter of the complaint
which will be issued for the violations of Section 15
of TSCA as described in the first paragraph of this
letter; and
7. Olin Hunt Specialty Products, Inc. certifies that the
information which it shall supply to the Agency will be
true, accurate, and correct.

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—3—
Please sign in the space provided below if you agree and
consent to the terms of this letter. Upon receiving the letter
with your signature, I will also sign this letter and the author-
ization for the use of the subject chemical will begin in accor-
dance with the, conditions set forth above.
Sincerely yours,
Michael F. Wood, Director
Compliance Division
s4/ “
Date
SEEN AND AGREED TO:
Blak’é A. Biles, Counsel
Olin Runt Specialty
Products, Inc.
Date

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p

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SY4 1
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
4 , 0 it
- OFrICE 0
PESTICIOtS AND TOXIC SUOSTANCCS
MEMORANDUM
G I6 85- -
SUBJECT: Sugarhouse Realty, Inc.
FROM: Marcia E. Williams L J
Deputy Assistant Administrator
for Pesticides & Toxic Substances
TO: Courtney M. Price
Assi tant Administrator for Enforcement
and Compliance Monitoring
I have reviewed Region III’s findings concerning the trans-
formers located at Jack Frost Sugar House, 1015-1021 Penn Street,
Philadelphia, Pennsylvania. I concur with Region III that the
presence of the PCB transformers and spilled fluid containing
13,000 ppm PCBe in an unBecured area constitute an imminent and
substantial endangerment to the public health or welfare and that
they present an imminent and unreasonable risk of serious. injury
to health.
I,

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UNIThD STATES DISTRICT cØ
FOR THI . ASL .RN DISTRICT OF L NNS’LLVANLA
I I TPt . lATT R OL• )
)
UNIT D STATES OF AMERICA )
) CIVIL AcTION NO.
)
v. )
SU AItKOUSE REALTY, iNC. )
WiLLIAM h. THAYER )
JOSk .PIW4E ThAYER )
AFFIDAVIT
CliRISTOPHI.R b. PILLA, Environmental Scientist 1 United States
Environmental Protection Agency (EPA), Region III , bsii g duly seorn,
deposes and says:
1. I am employed as an Environmsntal Scientist assigned to the
TSCA/FIPRA Enforcement Section, Huardous Vests Enforcement Branch,
tazardous JasLs Management Division, EPA Ragicu III.
I as the polychlorinated biphenyl (PC$7” CospUance Monitoring
Progras Coordinator and, u part of sy d ti.s, I as auchorisad by the
Regional Mministrator of EPA, R.gion III, to conduct of tidal
inve$ti$stion. and inspactiona pursuant to all Federal laws ad niat.r.d
by EPA.

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3. AS 3 reSult ot 1nSpect ons and 1nv t1gac1on oX c c r.
Jack ‘rosr Sugar House (the factLity) located at lOt5—ltJ’ L Penn Str :.
Philedeiphia, Pennsylvania, the .PA baa deterin.tned that substantiat
quantities ot the chemical substance known as polychlorlnated biphenyl(s)
( ‘CBa), a hazardous substance, and may in the future be spilled
from equipment containing PCBa and that the PCBs are present in quantl:ie.
and condition. which risk exposure to persona who may enter the facility.
Despite EPA ’s efforts to obtain compliance with the statutory and
regulatory requirements relating to PCBs and to obtain voluntary actions
which would secure the facility to reduce or prevent human exposure.,
the facility remain. readily accessible to treepaseer., including
cMldren. In light of these facts and clicumetances, on August 1.6,
1985, 2PA determined that conditions at the facility asy be an iaslnent
and substantial endangerment to the public health and the environment
pursuant to Section lOb of the Comprehensive Environmental Euponse,
Compensation, and Usbility Act, 42 U.S.C. 1 9606 (“CERCLA). EPA
ha. also determined that conditions at the facility present an unisasonabi
risk from an imminently hasardouo chemical substance pursuant to Section
7 of the Tonic $ubst*nces Control Act, 15 U.S.C. I 260b ( TSCA ). *
detailed chronology of EPA ’. actions respecting thi. facility and of
the events leading to EPA’s determinations of imminent hazard are set
forth in numbered patsgrspbs bs3ov.

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4. On April 1, l9 4, 1 r cei’n d an anony tuus i hone call COm crr
the miehendling o po1ychiorinatc d biph nyi (PCB) çuipin c at th
tormer Jack Frost Sugar 1Icus located at 1Ol5—lO l Penn Street,
Philadelphia, Pennsylvania.
. On April 9, 1984, 1 and Patricia Tan, also a duly authorized
inspector with PA Legion Ill, inspected the old Jack Froet Sugar Rouse
for compliance witt regulations promulgated pursuant to Section 6(e) of
the Toxic Subetancee Control Act (TSCA). The facility is located along
the bank of the Delaware River.
6. At the time of the April 9, 1984 inspection I observed ten
out ot service PCI containing PCI transformers and three empty PCI
contaminated transtormers. The PCI transformers were identified u PC
by the PCI trad nsaes appearing on the nameplate to the transformers;
namely, Pyrano]’, “Chlor.xtol, and NNOfl 11. b1. Liquid and the
yellow PCI warning label.
1. At the ties of the April 9, 1984 PC) inspection, violations
of the PCI transformer periodic visual inepactio and usocisted record—
keeping requirements and the Annual Donusent Inventory requirements
were dovusented.

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4
8. On ApriL 9, 1984, the tori er owner ot the racility reporc d
the presence of 150 PCB capacitors at various locatiuns throughout the ac1ti;y
9. On November 8, 19b4, I received an anony oua phone call
concerning the illegal scrapping of PCI transformers at the former Jack
Frost Sugar House at 1.037 N. Delaware Avenue in PhiladeLphia.
10. On November 8, 1984, I and Roger Meyer a duly authorized
Inspector with EPA Region III, of the Emergency Response Section of the
Supertund kanch of EPA Region 111 inspected the facility. At the time
we deter ine4 that the complaint was nor valid for the PCI transformers
observed at that time. however, it was apparent that salvaging of the
facility interior was occurring including non—PCI items located in the
PCI transformer areas.
ii, On November 14, 1984, I and Stephen Hirsch, a duly authorized
inspector with the Environmental Services Division of EPA Region 111,
inspected the facility to verity that all of the PCI transformers
observed at the ties of the April 9, 1964 inspection had not been
tampered with. None of the PCI tran.iorsers observed at the ties of
the April 9, 1984 inspection bad been tampered with and no PCI had
been spilled based on that inspection. It was apparent that dismantling
of other metal—based non—PCI equipment was occurring. Welders torch..
were present.

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5
12. On November 11, j9 4, a TSCA admirtiatr c1vc co p1aint was
Issued Co the owners of the tacility or violations o the PCØ regu1acion
documented at the time of the April 9, 1984 PCB Inspection.
13. Durir g the period ot negotiating a acttlement with owners of
the tacility, regarding the November 14, 1984 administrative complaInt
it came to my attention that ownership of the facility had changed hands.
14. On January 10, 1985, 1 forwarded a lettet, certified sail,
return receipt requested, to Mr. William Thayer, th. new owner of the
tactilty, apprising bin of hi. reaposaibilitie. under the PCI regulations
and the presenc. of PCI transformer, and PCI capacitore at th. facility.
I also for’watded a copy of the PCI rsgulstions to his. Th return
receipt cud was signed by an agent of Mr. Thsy.r on Jan isry 11, 1985.
A copy of this letter Is attached hereto a. Ishibit A.
15. On July 2, 1983, 1 received an anonyu is phosa call that the
PCb transformers at th. old Jack Prost Sugir Rouie had been veodalised
and several gallon. of PCI. had been spilled.

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16. On JuLy 2, L 8 I acid Patr c1a tan inspe Led the racliity ac :
tound that two PCB transforc era, serial. nuxbers l8 —I . 2 and l8 5—119,
b artng th PCB tiuld tradenane “Chiorextol” and the yellow PCB werntc g
label, had been vandalized such that the entire PCB fluid contents of
both had been spilled (270 gallons each). I collected a composite auiple
of the spilled fluid as witnessed by Patricia Tan, which was later analyzed
ana found to contain, in excess of 13,000 parts p.r million (ppm) of PCBe.
17. On that aaz day, I observed another PC$ transformer which also
appeared to have been vandalized. This tranaformsz serial number 101—
46— J, bore the yelLow PCB warning label and the PCU fluid tradename Non
Flammable Liquid”. 1 witnessed a composite sample collected from a pool
of liquid it the transfor5eT’I bass by Patricia Tan. I believe that a large
large volume of the 670 gallons of fluid contained in this transformer iad
leaked based on the sound made upon tapping the transformer. The sample
of spills4 PCB was sualytid and found to contain in excess of 13,000 ppm
of PCk. I received thi. analysis on August 13, 1983.
18. On July 2, 1985, I observed a winding which I believe vs. stripped
from a piece of unidentified electrical equipment. Patricia Tan collected
a sample of th. paper insulation from this winding which was later analyzed
and found to contain £n excess of 250 ppm of PCBs. I iiitnes.sd lb. Tan’s
collection of this sample.

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7
19. On July 2, l98 , I cc lL’ct d cor pc;1 cjirtldebr:s sa p
iii an area removed irom the 1ocat on of che spi’ 1& : PCH and teak1: g
PCb transEor s. Patricia Tan witnessed y coLlection of this sa p1e
which was lacer analyzed and found to contain in exce of 70 ppm of
Pt.. Is.
20. On July 2, 1985, 1. observed a sump located outside of the
building housing the transformers, away Iron the general. vicinity of
the PCI transforneru and spilled PCI.. The sump contained water and
oil. I collected a sample ae witnessed by Patricia Tan which was later
analyzed and found to contain in excsss of 14 ppm PCBa.
21. On July 2, 1985, 1 obierved that in general, since my initial
inspection of ApriL 9, 1984, the condition of the PCI transformers •nd
the facility had greatly deteriorated. Electrical equipment such as
switch gear h d been vandalized, a d haphazardly strewn around the
room where the VCI transformer. ar. located.
22. On July 2, 1985, 1 observed several persons on the site
collecting scrap natal. Three of these persons were chi1drs .
23. On j,gy 2, 1985, 1 advised several contractors of the ner
of the facility to stay away fro, the spilled PCI., and the PCI
traoafoimer. for health and safety rsuons.

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a
4. On July , 19S5, I m’ t with r. iLUe Thayer, the own
the tacli4ty end his p rForr d environnental Cleanup contractor. I
apprL ed Mr. mayer that the faciLity n ded to be secured, the C8
concaa.inatioii problem a isessed, and the PCIk cleaned up. Mr. Thayer
agreed to these measures. It b’C.5 agreed that I would forward Mr. Thayer
a letter contirining our meeting and his comm.ttment to address the
spilled PCI. and dormant PCI equipment and to secure the facility, to
which Mr. Thayer would respond in writing.
2 . On July 16, 1985, 1 forwarded a letter to Mr. mayer confirming
our meeting ot July 8, 1985 describing EPA’. concerns, and what needed
to be done to address the PCI situation. I requested a written response
to that letter by JuLy 23, 1985. A copy of this letter is attached
hereto u nhibit I.
26. During the period of July 25, 1985, to August 8, 1985, 1 made
a number of calls to Mr. Thayer’s office requesting a response to my
JuLy 16, 1933 letter, and a statue report regarding th. PC) situation
at his facility. Mr. Thayer was not available for these calls except
for one. Mr. Thayer acknowledged recsipt of my letter during this on.
‘conversation. I told Mr. Thayer chat I n..d.d a response in vritin$
and that I intinded to visit the site to obeerve what progress had
been asda. Mr. Thaysr reported that a 24 hour guard was now on duty
at th. facility, and that plan, had been finalized to have flood lights
and a fence •rected. During one of the calls prior to the one with
Mr. Thayer the woman I talked to, which I bell.,, is Mr. thayer’s
secretary, also acknowledged receipt of my July 16, 1983 letter.

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9
Z7. cm Itu u t i, 19?,5, I visited the site ound tit) guard
1 re ent, aud the t.icility accessible Co Cha public since there is —
eftective phys cai barrier to prevent access. I observed through the
window-Ot a snail room at the northwest corner of the facility a sign
for a guard. The sign—in log bore the name Kuma—K 9 Security
. .c. The log indicated that a guard had signed In on August 6 and 7
at 4:30 p.m. and signed out at 12:00 p.m. For August 7, 1985, th, log
stated that some one got into the building. For August 8, 1985, th.
log stated that made tour around plant, one door in back. of building
was open and one door in front was op.nH. I also spoke with a Phila—
delpMa Police Otticer who stated that the facility had been burglarized
that morning.
28. On August 13, 1985, 1 received the analytical result. for the -
sample. Collected on July 2, 1985 from kPA’s Central Regional Laboratc
in Annapolis, Maryland. Thus sample results are listed in previous
paragraphs.
29. On August 14, 1983, I and St.phsn Jarvela, a duly authorised
On Scene Coordinator in the Ergency Response Section, of lbs Haurdoua
Waite Managensel Division, IPA Region III inspected the old Jack Frost
Sugar h as. to determine whether the condition of ths PC$ transfot ti
and the presenc. of spilled PCIe constitutes an I nent and .u tantial
eodsngernt to the public hesith, welt are and the envirou nt.
30. On August 14, 1985, 1 chewed Stephen Jarvela the location of
spilled PCI. and the vandaUsed PCI trs..formsrs from which the PCIS
had spilled. I showed Mr. Jarvela the associated electrical •qnipmsnt
which had b.e. v.ndalissd.

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10
31. iollow1n my and Mr. Jarve1a’ tour or the facility, Mr.
Jarvela reported to oe that he would recommend chat PA deter CI; c
the COndition of the PCB transfurners, and the spilled PCS Iluid, posed
an lnm.tnent and substantial endangerment to the public hcalth, welfare
and the eflvtronment with the threat to the public being one of direct
contact exposure and possible entry of PCBs into groundwater and the
Delaware River.
32. on August 15, 1985, 1 accepanied Edward T. Ellis the Assistant
United States Attorney repruenting EPA, to the •ite of the facility in
order to familarize him with the circumetancee of this sitter. On that
visit, I observed that conditions were as I had found them on August
14. In addition I observed that PCS transformer serial number P1885-179
had developed a leak and vu now dripping on the concrete floor. At
the tims of our arrival and during ths courss of our visit of approximately
thrity minutes there was no guard present at the facility and there was
no affective barrisr to prevent access.
33. On August 16, 1985, the Regional Msinistruor f or EPA, Raglan
LI!, pursuant to duly delegated authority, determined thn the
circumetsocas at the facility may be an imminent sod •ubst aitial
endsugerm.nc to th, public health or wslfare or the snviromesnr and
thu they present an imminent and uoreasonsbls risk of serious or
widespread injury to h•alth or the euviro nt. Copiss oS the Regional
Mministrator’s determinations are attached hereto u Exhibit C.
GERISTOPIIU: 5. PILL& - -
Enviromesut.]. Scientist
Subscribed and Sworn to me
this ___ day of 1983. .

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a
COVER SHEET FOR TELECOPIER 4ESSAGES
DArE:________________
TO: 2 4 Ltt
0 llOY,1 f’1 1/ L
DESK PHONE: jFG
PROM: Y)luI&&1II fllA4L4& t .
DESK PHONE: 5cpf 09?S
TOTAL $ 0? PAGES(NOT including cover 3heet) — /0
TELECOPIER TELEPHONE $, EPA REGIOM III ____ _________

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0

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U.S. ENVIRONMENTAL PROTECTION AGENCY
REGION X
1200 SIXTH AVeNU!
SSATTL . WASHINGTON 9! tot
Office of Pegicrial Cou sel, MIS 613
S
This letter advises you that the s rn interview of yourself currently
being conducted by this Agency ha. not been cc.pleted, and you are required
to return to this offic. for cc p1ee1cn of that interview at the fotI.owttig
t1 e On thi following date:
D t:
DAX OF WE 1C:
We iL1]. make sincere efforts to caitp].ete the interview on that date,
and m regret that our duties require that inconvenience you further in
thi matter. Your indulgence and patience with our efforts uld be apprecia-
Sincerely,
If have any questions concerning this matter, please contact ne,
at 442—1275.
Assistant Regional Cou se .
HPIT 10
*ITN OP
to
ted.
000009
Page 1?

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§ 1001.
Whoever, in any matter within the Jurisdiction of any department
or aiency of the United SLates knowinhly and willfully falsifies. COfl•
c.al or coven up by any trick, scheme. or device a material fact, or
makes any false. fictitãous or fraudulent statements or repre1snta
tions. or makes or uses any false writing or document knowing the
same to contain any falae, fictitious or fraudulent statement or entrY.
shall be fined not more than $10000 or imprisoned not more than five
years. or both.
June 25. 1941. c. 645. 62 Stat. 749.
Page 18

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
)
In the
MatterOf:
)
)
PILOT
CHEMICAL COMPANY,
spondent.
)
)
)
)
Docket No. TSCA—87-H—12
SUBPOENA AD TESTIFICANDUM AND
SUBPOENA DUCES TECUM
SUBPOENA AD TESTIFICANDUM AND SUBPOENA DUCES TECUM
TO: AUBREY M. KIRBY, JR.
Sun Refining and Marketing Company
Ten Penn Center
1801 Market Street
Philadelphia, PA 19103-1699; RESPONDENT TO THE SUBPOENA
YOU ARE HEREBY COMMANDED, pursuant to the provisions contained
in Title 15, United States Q,de, Section 2610(c) (Toxic Substances
Control Act Section 11(c)J, and 40 Qde of Federal Regulations
Section 22. 33(b), TO ATTEND AS A WITNESS at the hearing in the
above—captioned administrative enforcement action to testify
regarding your Affidavit of July l0 ’, 1987, hereto attached and to
be offered into evidence by Complainant U.S vironmenta1 Protection
Agency at the hearing, AND PRODUCE AS DOCUMENTARY EVIDENCE all
documents (as defined below) which you relied upon in preparing
the aforesaid ffidavit, at the fo11owin dates, times, and places:
DATES AND TIMES: November 8, 1988 ____________________
November 9, 1988
PLACE: Los Angeles, California —
( Specific location to be determined - contact
Bessie L. Hammiel, Hearing Clerk, Office of
Administrative Law Judges, at (202) 382—4865
for further information ]
YOU ARE COMMANDED FURTHER:
TO BE AND APPEAR IN PERSON, with all the documents identified
above, before Administrative Law Judge J. F. Greene at the above
dates, times, and place;
TO TESTIFY then and there upon oath and MAXE TRUTHFUL RESPONSE
to all lawful inquiries and questions then and there put to you
by the Parties to the proceeding; and
TO REMAIN IN ATTENDANCE until expressly excused by Administrative
Law Judge Greene.
2:00 p M — 500 P M.
9:00 A.M. — 5:00 P.M.

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—2—
DEFINITION
For purposes of this SUBPOENA, the word “documents” means all’
written, typewritten, handwritten, printed, or graphic matter of
any kind or nature, h iever, produced or reproduced (including
any copies containing additional matter), any form of collected
data for use c ith electronic data processing equi nent, and any
mechanical or electronic visual or sound recordings including,
without limitation, all tapes and discs, n or formerly in your
possession, custody or control. It includes, but is not limited
to, any logs of materials or containers shipped, other loas,
invoices, purchase orders, checks, receipts, bills of lading,
weight receipts, toll receipts, loading tickets, receiving tickets,
shipping orders, manifests, inventories, letters and other
correspondence, offers, contracts, agreements, bids, proposals,
licenses, permits, reports to government agencies, ledgers,
accounts receivable, accounts payable, account statements, financial
statements, monthly reports, other reports, minutes of meetings,
sales estimates, sales reports, source and use analyses, memoranda,
handwritten or other notes, calendar or diary entries, agendss,
bulletins, graphs, charts, maps, photographs, drawings, surveys,
data, sampling results, analytical results, descriptions of
materials, load schedules, price lists, sinnmaries, telegrams,
teletypes, computer printouts, magnetic tapes, discs, microfilm,
and microfiche.
PURSUANT TO THE AUTHORITY OF SECTIONS 16 AND 17 OF
THE TOXIC SUBSTANCES CONTROL ACT, FAILURE TO COMPLY
WITH THIS SUBPOENA MAY RESULT IN THE INITIATION OF
COURT PROCEEDINGS IN A UNITED STATES DISTRICT COURT
AGAINST YOU TO COMPEL COMPLIANCE WITH THE SUBPOENA
ISSUED at Washington, D.C., this ____ day of __________, 1988.
Hon. J. F. Greene
Administrative Law Judge
United States & viron - ta1 Protection Pqency
401 M Street, S.W. (A—hO)
Washington, D.C. 20460

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UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
In the Matter of
:
S
S
SUN REPINING AND
:
MARKETING COMPANY,
:
Respondent
S
STATE OF PENNSYLVANIA
•
• _.
Docket No. TSCA-87-N-07
COUNTY OF PHILADELPHIA
S
S
AUBREY H. KIRBY, JR., being duly sworn
law, deposes and says as follows:
acccording to
1. From January 1, 1982 to December 1, 1986, I was the
Manufacturing Coordinator, Oil Recovery Chemicals and
Services, Applied Research & Development for Sun Refining
and Marketing Company;
2. During the time period referred to in the previous
paragraph, I coordinated the manufacture of Sun Tech IV-1035
Sulfonate, whose chemical designation is poly alkyl
benrenesulfonate which is benrene sulfonic acid, methyl,
mono C 10—20, alkyl derivatives, sodium salts;
3. Sun Refining and Marketing Company (Respondent)
filed a Consolidated Premanufacture Notice (P)O1) with the
Administrator of the Environmental Protection Agency (EPA)
for poly alkyl benzenesulfonat. which is benezene sulfonic
acid, methyl, mono C 10-20, a]kyl derivatives, sodium salts
(chemical “B”) on December 2, 1982;
4. Th. number for the notice referr.d to in the
previous paragraph was P)W 306;
5. The end of the P O1 review period was April 18, 1983;
6. A Notice of Commencement to Manufacture was sent to
EPA on July 22, 1983 as reported in 48 P.R. No. 191,
page 44897;

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(2)
7. Respondent followed all the required statutory
provisions with regard to the production of Chemical “B”;
8. In October, 1983, Respondent contracted with Pilot
Chemical Company to produce chemical “B”;
9. During th. production of Chemical “B” at the Pilot
Chemical Company plant, Respondent had no control of the,
total amount of Chemical “B” produced or the basic
technology for the plant process utilized to produce
Chemical “B”;
10. After the production referred to in the previous
paragraph, Chemical “B” was delivered to Respondent by Pilot
Chemical Company.
11. Respondent has never contracted with Pilot Chemical
Company to produce benezenesulfonic acid, methyl -, mono - C
10-20— alkyl derivatives (Chemical “A”);
12. Respondent has never accepted delivery of Chemical
“A” from Pilot Chemicals Company.
A rey M Kirby, Jr. -
SWORN TO AND SUBSCRIBED
BEFORE ME THIS 10th DAY
OF JULY, 1987.
L (.TY Ct44
Notary Public LS V. !;r’ 1 cv cLa I
JhI dsI rIis. Ph: ,L:3hlz Cc• . , ty. M
Mp Cw— $S’3t. .1 i :.’.I . . t ?S

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Date of Service: ________________________________________________
Time of Service: ________________________________________________
Place of Service: ______________________________________________
3. t effected that service of the said subpoena in the manner checked below:
_____ By handing a true copy into the hands of the person named above and
leaving the said copy with the said person.
_____ 3y substituted service, that is, by delivering a true copy of the sat:
subpoena into the hands of an individual of suitable age and discre-
ho s at the residence and hane of the person named in paragraph 2
above and is believed by me to reside therein, and leaving a true co y
of the said subpoena with the said individual.
_____ By (registered mail] (certified mail return receipt requested] addressec
to the person and address stated in paragraph 2 above, a true copy of
the receipt for the said mailed subpoena being attached hereto.
B ORE T} UNITW S1’AT VI N tAL P TEC ICN icy
EPA R IC 10, 1200 STXfl! AVE IUE
Seattle, WashIngton, (206) 442-1275
IN THE HA1’I’ OF:
4O.______________
AFFIDAVIT OF SERVICE OF SUBPO ZA
UNITE SIAItS OF A €RICA)
StAlE OF ) $3.
C JWI? OF ) The Affiant undersigned, first being duly s rn,
upon oath, deposes and says:
1 • Attached hereto is a true copy of a subpoena issued by the United States
Fxivirormiental Protection Agency (EPA).
2. 1 made service of the said subpoena upon the following naned person
on the date stated at the place stated:
Person Served:
I
2
3
4
5
6
7
B
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24 Dated:
25
26
27
28
Form 080 .103
13.0.78 OW
AFFL (r
SUBSCRIBE AND S RN before rue, the undersigned flotary Public, this
of ________________, 198_.
1OtARY PUBLIC in and for tre 5c e
of , residing at
Page ti

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BEFORE THE UNITED STATES ENV!ROI’1IENTAL PROTECTION AGENCY
EPA REGION 10, 1200 SIXTH AVENUE
Seattle, Washington, (206) 442-1275
IN THE HATTER OF: NO 1084-06-I1-]04Ew
60 to 65 Acres of Land in Kitsap
County, Washington Containing OATH OF SUBPOENAED WITNESS AND
Ron’s Wrecking Yard
CLAIM FOR FEES AND MILEAGE
____________________________________________ BY__________________________________
UNITED STATES OF AMERICA)
STATE OF Washington ) ss.
COUNTY OF king ) I, the undersigned afflant, first being duly
sworn, upon oath, state that I will respond truthfully and completely to all
questions and inquiries lawfully put to me In these proceedings.
(Si gnature)
UBSCRIBED AND SWORN TO BEFORE ME
this ______ day of ______________, 198.
NOTARY PUBLIC in and for the State of
___________________ residing at______________
CLAIM FOR FEES AND MILEAGE:
Attendance fees (@ S30.OO per day)
Coiiinon Carrier Trave’ Actual
Privately Owned Vehicle Actual Round—trIp Miles Travelled xSO.16S
To 1 1 Cha r ge s Actual ly Pal do e_ _ a a a_a a a a a e a a aaaaa*aa a $
Subsistence (For Overnight Stay) Actually Incurred—————————--—————-S_
TOTAL: S
Claim is hereby made for the total amount above pursuant to
‘5 U.S.C § 2610(c) and 28 U.S.C. § 1821.
4te:________________________________ ____________
(Si ynatur.)
Mailing Address:______________________________________
WITNESS OATH AND CLAIM FOR FEES AND MILEAGE
Page 16

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U.S. ENVIRONMENTAL PROTECTION AGENCY
REGION X
1200 SIXTH AVENUI
UATTLE, WASHINGTON 98101
pq it
UP%! TO
AtTN OPt
Office of Regional Co msel, MIS 613
10
This letter advises you that the si rn interview of yourself currently
being conducted by this Agency has not been canpieted, and you are required
to return to this office for cauplec ton of that interview at the followiiig
time on the foilo ng date:
- DATE:______
DAY OF WEEK:____________________
We will make sincere efforts to complete the interview on that date,
and we regret that our duties require that we inconvenience you further in
thifl matter. Your indulgence and patience with our efforts uld be apprecia-
ted.
If you have any questions concerning this macter, please contact me,
______________________________ at 442—1275.
Sincerely,
Assistant Regional Co se1.
Page T.7

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§ 1001.
‘Wbov.r, in any matter within the jurisdiction of any department
or agency of the United St.ate.i knowingly and willfully falsifies. con-
ceala or coven up by any trick, scheme, or device a material fact, or
makes any false, fictitious or fraudulent statements or representa.
tions. or makes or uses any fals. writing or document knowing the
same to contain any false, fictitious or fraudulent statement or entry.
shall be fined not more than $10,000 or imprisoned not more than five
years. or both.
June 25. 1949. c. 643. 62 Stat. 749.
Page 18

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0F I IAL ANSW SU8PO LA DUCFS TF f BY M iIL
O RES D :
You havi been served with an EPA a iniscratlve subpoena duces tecun issued
pursuant to the Toxic Substances Control. ACt (TSCA), 15 U.S.C. S 26 i and
foLlowing sections. That subpoena requires that an individual personally
attend a meeting at the time and place listed in the subpoena and then and
there give testimony sider oath and also produce the records indicated in
the subpoena.
EPA hereby offers to you the alternative of responding to the subject subpoena
by mail rather than attending in person and producing records and giving test i-
mony. You uld be spared personal inconvenience by electing to respond to
the subpoena by mail. Ho ver, you must follow carefully the following
instruictions if you elect to respond to the subpoena by mail:
1 • You must telephone the following person pLw tly and state specificalLy
that you thereby elect to respond to the subpoena by mail rather than in per-
son. You must follow up on that call by sending a letter to the sene ef ect.
_________________________________ Telep uie:_____________
Address:
2. You must make xerox or photocopies of each record which is in your pos-
session or othetwise available to you, which you believe canes Within the des-
cripcion set forth in the atcathnent to the subpoena. You must take care to
include all records which the attact ent reasonably describes because you could
later be subpoenaed again.
3. You must then package up those records and mail then or otherwise have
then delivered ( together with an affidavit ) to the person named in paragraph
1 above at the address stated there.
4, The affidavit which must acc noany the shipped records is attached to
these Instructions and must be signed and s rn to before a Notary Public.
Please take care to read the affidavit carefully and he sure chat you u der-
stand it b.for. you sign and s ar to it.
5. The affidavit and all the records must be in the hands of the person
named thparagraph 1 above by the time specified In the subpoena. If it is
absolutely necessary to request an extension of time, call the person named
in paragraph 1 above to see whether an extension can be granted, and, If so,
what the replacenent return date will be.
6. If you claim that sane portion of, or all. of, any record covered by
the said subpoena is privileged, this obtion to respOnd by mail, is x avaiLabl.e
to you, and you must appear in person at the time and place stated.
OFFI OF R I NAL WJNS
Page 1.t

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DRE ThE LJNLI ST IE5 VL th 1IAL F TEC L 4 ICf
EPA R I0N 10
AFFE AVIT RE P(14DI BY MAIL TO SUBP0E1 A DUCES TECUM
_ .ATEOF ____________)
) as.
COUNTI OF ________________) I, the n dersi ed a.ffianc, first being
duly s rn, upon oath, depose and say:
1. Attached hereto are pages of photocopies of doc .inents or records.
The attached pages are true and correct copies of records which I presently
have in my custody and/or control as an owner and/or np1oyee of:
_________________________________ the address of which is _______________
.
2. 1 i one of the custodians of the records of which the attached pages
are true and correct copies. Those records have been subpoenaed by EPA arid are
ethg produced along with this affidavit in response to that subpoena.
3. The records (of which the attached pages are true copies) here invol.ved
te and/or are received and/or kept in the usual course of the regularly con-
:ced business and activity of the entity listed in paragraph 1 above. The
maid records are relied upon by me and others for the purpose of conducting
every day affairs. The said records are usually prepared or re received at
near the time the events to which they relate, upon the basis of knowledge
f such events either by the person preparing the record, or knowledge of the
?erson cran nitting the infonnatton so that such record could be prepared.
I have made a diligent search arid inquiry for all records which are
reasonably described in the subpoena to which this affidavit responds. I have
not foixid or Located, and I have not been cold about, and I have no knowledge
of, any records caning within the descriptions set forth in the said subpoena
which have riot been copied and subuitted along with this affidavit.
5. 1 acknowledge that this affidavit is su±itted to the United States
in connection with a n atter within the jurisdiction of A and that any ma.
cerial false statenent of fact herein may be a crime i.rider 18 U.S.C. S 1001.
_________________________ SI I E D:______________________________
‘riPED NAZ’IE:______________
OFFICE OR TITLE:_______________________
RN AND SUBSCRIBED TO before me, the t dersigned Notary Public on this _______
yof . 198
(SEAL) NOTARY PUBLIC in and for the State of
________________ residing at
age 20

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UNITED STATES ENVIRONMENTAL
PROTECTION AGENCY
In the Matter of
:
S
S
SUN REFINING AND
:
MARKETING COMPANY,
:
Respondent
U
:
STATE OF PENNSYLVANIA
S
U
S
• .
Docket No. TSCA-87-H-07
COUNTY OF PHILADELPHIA
S
.
AUBREY H. KIRBY, JR., being duly sworn
law, deposes and says as follows:
acccording to
1. From January 1, 1982 to December 1, 1986, I was the
Manufacturing Coordinator, Oil Recovery Chemicals and
Services, Applied Research & Development for Sun Refining
and Marketing Company;
2. During the time period referred to in the previous
paragraph, I coordinated the manufacture of Sun Tech IV-1035
Sulfonate, whose chemical designation is poly alkyl
benzenesulfonate which is benzene sulfonic acid, methyl,
mono C 10—20, alkyl derivatives, sodium salts;
3. Sun Refining and Marketing Company (Respondent)
filed a Consolidated Premanufacture Notice (P 1 W) with the
Administrator of the Environmental Protection Agency (EPA)
for poly alkyl benzenesulfonate which is benezene sulfonic
acid, methyl, mono C 10—20, alkyl derivatives, sodium salts
(chemical “3) on December 2, 1982;
5. The end of the P1*1 review period was April 18, 1983;
6. A Notice of Commencement to Manufacture was sent to
EPA on July 22, 1983 as reported in 48 F.R. No. 191,
page 44897:
4. The number for the
previous paragraph was P101
notice referred to in the
306:
000003

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(2)
7. Respondent followed all the required statutory
provisions with regard to the production of Chemical “B”;
8. In October, 1983, Respondent contracted with Pilot
Chemical Company to produce Chemical “B”;
9.- During the production of Chemical “B” at the Pilot
Chemical Company plant, Respondent had no control of the,
total amount of Chemical “B” produced or the basic
i.chnology for the plant process utilized to produce
Ch.mical “B”;
10. After the production referred to in the previous
paragraph, Chemical “B” was delivered to Respondent by Pilot
Chemical Company.
11. Respondent has never contracted with Pilot Chemical
Company to produce ben.zen.sulfonic acid, methyl -, mono - C
10—20— alkyl derivatives (Chemical “A”):
12. Respondent has never accepted delivery of Chemical
“A” from Pilot Chemicals Company.
.
A rey I4 Kirby, r.
SWORN TO AND SUBSCRIBED
BEFORE ME THIS 10th DAY
OF JULY, 1987.
4a i ( C.
Notary Public FVJI L v. c . IJLI
DJ I%ds1:rns. u I ,ii Ce.iwp. M
M C ari— ssi i !‘r s .‘.i :. . tc’

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R

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IN THE UNITED s’rA’rES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF FLORIDA
IN THE HA1 ER OF,
Basso Chemical Inc.
WARRANT FOR INSPECTION
UliDIRLI’H1 TOXIC SUBSTANCEE CON!MOL ACT
Tos
Donald Stack, Carlto HaLley, and Jill Perry, Enforcement
Off icers, U. S. Environmental Protection Ag.ncy, Region IV;
Application having b..n.mad• and probabl• cause shown, by the
U. 8. Attorney for the Northern District of Florida, for a
warrant to enter, inspect and sample ths establishment described
ass
Basso Chemical Inc.
3211 Pow.rg Avenu•
Jacksonvill•, FL 32207
Pursuant to the Toxic Subutance Control Act, 13 u.s.c. 2610,
and the decisions of Ut• Supreme Court in Xmrshal.1 vrl pi’i. _
Inc. . 98 S.Ct.
1816,
you ar. authorized to “ mediate1j enter thi above-described
premises upon presentation of this warrant at reasonabi. times
during busin.ss hours to inspect all process.., controls, and
facilities; to inspect and copy all records, f ties, and papers
regarding manufacture, processing, distribution, sale,
packaging, transportation, storag. and/or disposal of chemical
substances associated with the premises; and to inspect and
sample any and/or all chemical substances or mixtures within the
premises or in/on any conveyance utilized in th, transport of
chemical substances or mixtures at or near the premises to
determine wh.th•r the r.quirem.nts of the TO*ic Substances
Control Act applicable to the facility and/or th. chemical
substances or mixtures hays been complied with.
The duratioa of the inspection shall be of such a length as to
enable the abov...naaed enforcement officers to satisfactorily
coaplet the inspection.
DATED. _ -
JUDO!
Inspection of the establishment described in this
warrant was completed on __________________

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unless th. natur, and extent of such data are deacrli
with reasonabi. specificity in the written notice
required by subsection (a) for such inspection...
3; ..so Chemical Inc. is engaged in th. business of
manufacturing, processing, sailing, distributing, and/or
disposing of chemical substances and mixtures.
4. This warrant is required in order to obtain
information necessary to ____________
5. The inspection viii. begin as soon as practicable
aftar issuance of this warrant and viii be conducted with
reasonable promptness but continuously and without interruption
until conpl.ted.
6. The enforcement off Lc.r may be accompanied by one
or more other employees of the United States Invironmental
Protection Agency.
7. The .nfordement officer requests imesdiate entry
to Basso Chemical Inc. tO perform the inspectiom.
3. A return will be made to the court at the
compl.tion of th. inspection.
9. The authority for ths issuanc. of th. Lnapectio
warrant is Section i i of the Act, 15 U.S.C. 26lO, araI1ai.1.jrA...
Barlow. Inc. , 90 I.Ct. 1816, _ — — — . C.’i. , •
Donald 8tac
Assistant Regional Counsel
US IPA, Region XV

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sale, handling, packaging, transportation, storage and/or
disposal of polychiorinated biphenyls(PCB 5) in any form during
the period of April 10, 1970 through the pres.ntj and inspection
and sainp]ing of all PCI chemical substances, PCI mixtures, PCI
articles, and PCI container, located at the premises or in/on
Conveyances ut5 1ized La the transport of chemical substances or
mixtures at or near th. premises.
2. This warrant is sought under Section 11 of the Act, 15
U.S.C. 2610, which provides in pertinent parts
SIC. 11 INSPICTIOIII AND $UBPOENM.
(a) In General..4or purposes of administering this
Act, the Administrator, and any duly designated
representative of the Administrator, may inspect any
establishment, facility, or other pr.ts.s in vhjç)
chemical substances or mixtures are aanufactur.d,
processed, stored, or held before or after th.ir
distribution in co erce. Such an inspection say only
be mad• upon th. presentation of appropriate
credentials and of a written notice to the own.r,
operator, or agent in charge of th. premises or
conveyance to be inspected. & separate notice shall be
given for each such insp.ctionb ut a notice shall not
b required for each entry made during the period
covered by the inspection. Saab such inspection shall
be co’, a.nced and completed with reasonable promptness
and shall be Conducted at reasonable times, within
reasonabl• limits, and in a reasonable manner.
(b) Scope.-..(l) Ixcept as provided in paragraph (2),
an inspection conducted under subsection (a) shall
extend to all thinS, within the premises or conveyance
inspected (including records, tiles, papers, processes,
controls, arid facilities) bearing on whether the
requirement. of this Act applicable to the chsa.tcal
substances or mixtures within such premises or
conveyance have been complied with. (2) We inspection
under subsection (a) shall extend to-.
(A) financial data,
(I) sales data (other than shipment data),
(C) pricing data,
(D) p.rsonn.l data, or
(3) research data (other than date required by
this Act or under a rule promulgated ther*-
under),

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IN TIlE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
IN TIlE NATTER Oi l
Baiso Chemical Inc.
- APP IDAVIT IN SUPPORT OP
APPLICATION P0* WARRAIf
STATS OP FLORIDA
COUNTY OP DUVAL
Donald Stack being duly sworn upon his oath, according to
law, deposes and sayss
1. I am a duly authoris.d snforcs.ant officer of Region
IV, United Stats. Environmental, Protection Agency. I hereby
apply for a warrant pursuant to Section 11 of th. toxic
Substance. Control Act (the ‘Act), IS U.S.C. 2610, fog the
inspection, copying, and sampling of th. items named below in
Uts possession, custody, or control of Basso Chemical Inc. on
the premises or in/on conveyances utilized in th. transport of
chemical substances or mixtures at or near the premises located
at 3211 Powers Avenue, Jacksonville, Florid..
To inspect all proc•ss.s, control., and faeLlitL.s to
inspect and copy all records, files, and papers; and to inspect
and sampis any or ill chemical substinces OX mixtures within the
pami see or in/on convs es utilized La the transport of
chemical substances or mixtures at or near the premises bearing
on whether tb. requirement., of the Toxic Substances Control Act
pplicabl. to the chemical substances and mixtures hav bean
complied with. The above data should incluad inspection of all
processes, controls, and facilities; inspection and copying 00
all record., files, and paper, bearing on or relating to the

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-2.
This warrant is sought und.r Section 11 of the Toxic
Substances Control Act, 15 U.S.C. • 2610 which provides, in
pertinent parts
(a) Zn General. For purposes of adminiat.rin
this Act, the Administrator, and any duly designate
representative of the Administrator, may inspect any
establishment, facility, or oth.r premises in which
chemical substances or mixtures ar manufactured,
processed, stored, or held before or after their
distribution in coemrce. Such an inspection may only
be made upon th. presentation of appropriate
credentials and of a written notici to the owner,
operator, or agent Lu charg. of the premises or
conveyance to be inspected. A separate notice sh 1l be
given for each s ach inspection, but a notice shall not
be requir.d for each entry mad. during he period
covered by the inspection. Sach such inspection shall
be comeenced and completed with reasonable promptness
and shall be conducted at reasonable times, within
reasonable limits, and in a reasonable manner,
(b) Scope.-’u(l) Sxc.pt as provided in paragraph
(2), an inspection Conducted under subsection (a) shall
oxt.rtd to all things within the premise, or conveyance
inspected (including records, files, papers, processes,
controls, and facilities) bearing on whether the
requirements of this Act applicabl, to the chemical
substances or mixtures within such premise. or
conveyanc• have been complied with.
(2) Ne inspection under Subsection (a) shall extend
to—..
(A) financial data
(S) sales data (other than shipment data),
(C) pricing data
(0) personnel data, or
(I) research data (other than data required
by this Act or under a rule promulgated
thereunder),
rnlsss the nature and extent of such data are described
with resonable specificity in the written notice
required by subsection (a) for such inspection....

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—3—
Basso Chemical Inc. is engaged in the business of
manufacturing, proc.ssing, selling, distributing, storing and/or
disposing of chemical substances and mixtures, as these terms
ar, d.fined in Section 3 of the Act.
This warrant is required in order to obtain information
necessary io SPA to adequately discharg• its responsibilities
under the Toxic Substances Control Act, Section 313, 15 u.s.c.
________ ________ and to ensure that —.
Th, inspection will be conducted at a reasonable tim. by
duly authoris.d enforcement officers of the U.S. Invironnental
Protection Agency, legion IV, as soon as practicable after
issuvtc. of this warrant and viii be of such duration as to
allow the inspectors to satisfactorily complete the inspection.
WHERSIORI, SPA r.qu.sts that a warrant to enter, inspect,
and sample, and copying of records from the abov-refsr•nced
property be Lssu.4 for the purposes stated herein.
0000

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—4
Zn support of this application, the Regional Administrator
respectfully submits th. accompanying affidavit and propos.d
warrant.
Respectfully Submitted,
Unitd States Attorney
By, - -
Assistant U.S. Attorney
Northern District of Florida
Of Counsels
!dwin Schwarts
Assistant Regional Counsel
U.S. liwironmental Protection Agency
345 Couxtiand Stre.t, LW.
Atlanta, Georgia 30365

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IN PH! UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OP FLORIDA
IN THE XM’TER Oh
Basso Chemical Inc., Application for Wartant
3211 Powers Avenu• ) to Enter, Inspect and Sup.
Jacksonville, FL 32207 ) Pursuant to Section 11, of
the Toxic Substances Contri
Act, 15 U.S.C. Section 2611
)
CO1 5 NOW the ‘4 n3.strator of th. United Stats.
Environemntal Protection Agency (SPA), by and through U • S.
Attorney, and appli.. for a warrant pursuant to and accórdancs
with Section U of the Toxic Substances Control Act, 15 U.S.C.
52610, for the purpos. of .itabling duly authorised EPA
•nforcaemnt personnel to enter upon the premises of and to
conduct in a (nistrative inspection of Basso Chemical Inc., of
Jacksonville, Florida as follows,
To inspect all proc.ss.s. op.rationl, and facilities; to
Lnsp.ct and soise and/or copy all records, files and papers
regarding manufacture, process Lag, distribution, sale,
packaging, transportation, storage and/or disposal of chemical
substances associated with the premises; and to inspect and
sample .fl7 or all chasieal •ubataces or mixtures within the
premises or in/on conv.yanc.s used to transport such chemical
substances or mixtures at or near the premises to determins
whether th• r.quiza.snts of the To*ie Substancss Control Act
applicabl, to the facility and/ot the cPtical substances and
mixtur.s hays been complied with.
000011

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a
( swear that this inventory is a true end detailed account of the
roperty taken by me on this warrant.
• ,• •/•
— I,
4 II / ‘
- ‘ I,.—,.
Jonftt1 án 0. Al n ’
EP Enforcement officer
Subscribed, sworn before me, and returned to me on this date
7/27/i’j •
strat.
Date
£0d 9B&29 9 0.1. iS3d 8 X0J. III NOI d3 WO St:ST 68GT/G /8

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turn of gproh tajrant
Docket We. S9—14$M
1. Dat. of Warrant: une 29, 1989
2. Dates Warrant executed: Warrant was executed on July 5, 6,
i; 12, 13, and 14, 1989.
3. A certified copy of the warrant was given to Mr. Francis
Rattay and Mr. Spencer Nunley, both of Mobay Corporation, on
July 5, 1989.
4 • An inventory of documents taken and copied was mad• in the
presence of Mr. Francis Rattay and Mr. Robrt Sankston, both
of Moeay Corporation. Mr. Rattay also signed TSCA Receipt
for Samples and Documents forms for the documents taken and
copied.
5. A total of approximately 56$ documents were either taken or
copied on site. These documents measure approximately 18.5”
x a.S x 11..
6. The original documents taken from the site ar. mainly .Moba
product information publications which are generally
availabl, to the public. The documents taken are as
follows:
- Bonding Agent Additive ICA—9 12$ Product Information
- L.vatit/Lewa.orb: Ion Exchange Resins and Catalysts
Product Information (3-ring binder)
- Nydur A, AXV, and B V Product Information
- Roekydal 500* Product Inførmatioit
- Vulkacit RA-9124 Product Information
- craain Pigments: tionionic and Anionic Pigment. for
Textile Printing
- Lsvatit/L.va.orb: Ion Exchange Resins for Industry and the
Homa
- Kicro]u: Dyu for Plastics
- Rev Materials for High Performance coatings: Product Index
- The .miatry of Polyurethane Coatings: A General
Reference Manual
Other c” inta
- Bayer USA: Annual Report 198$
- Computer printout of liquidated and nonliquidated customs
entries (SALES3OIP REPORT)
- Mobay Corporation Organization Plan, February 3.988
- Mobay Facts booklet
000009i
e d 9982Z8 9 01 lSBd I X0i. I !! NO I DB d3 WQeU Pt : St 68GTi6 /8O

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UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OP PENNSYLVANIA
IN THE MA ZR OF! )
)
Environmental Protection Agency ) Docket No. 14s. I .4 SM
Administrative Warrant )
)
WARRANT AUTHORIZING ENTRY, INSPECTION,
COLLECTION, AND COPYING OP DOCUMENTS
PURSUANT ‘tO the Toxic Substances Control Act (TSCA) • 42 U.S.C.
fi 2601—2654;
TO: Hr. K. K. Wu md Mr. Jonathan Allen, United States
Environmental Protection Aqency (“EPk ), Region III, and any
authorized attorney or representative of said Agency or any other
agency of the Federal Government;
Application for entry, inspection, collection and copying of
documents having been made and applicant having deaonstrat d
through application and affidavit of Mr. Jonathan Allen, EPA Region
III , that the issuanc, of this warrant ii constitutional, based
upon a right of entry authorized by statute, and is based upon the
reasonable belief that violations of TSC& may be discovered, and
other sufficient cause for th• issuance of this warrant having been
demonstrated by such application and supporting affidavit and this
officer therefore having been satisfied that this warrant is
properly issued;
WHEREFORE, you are hearby authorized to enter the premises of
Mobay corporation, Corporate Headquarters, l4obay Road, Pittsburgh,
Pennsylvania, at reasonable hours of the day, commencing July 5,
1989 and continuing for fourteen days or until further action by
this court, for the purpose of inspection, colliction and copying
of documents, pursuant to TSCA. This authority shall extend to all
documents regarding various substances which wer, the .ubj sCt of
certain prs-panufaoturs notices (‘P C1e )and Notice. of Commencement
(NNOC5 ) • and products which may have contained thee . substances,
including, but not limited to, dyes, pigment., coatings, ion-
exchange resin, and coagul ants. The documents to be inspected,
collected and copied include:
1. Documents relating to Mobay Corporation’s r.cordkeepinq
policies.
2. Import Certifications under Section 13 of TSCA and
documents relating to the preparation of such
certificates;

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2
3’ U.S • Customs Service Consumption Entry Forms and Entry
S ries, and any related forms.
4. Import Invoices and Purcahse orders;
5. Intercompany order record ., transfer records and payment
record.;
6. Intracompany order records, transfer records and payment
records;
7. Sa].s maoranda, orders, bills and invoice.;
8. Shipping records;
9. Customer lists and accounts;
10. Product literature and catalogs;
11. Material Data Saf.ty Sheets;
12. Formulation records;
13. Product specification records;
34. Chemical composition records;
15. Correspodemce, notes and meat,randa regard ing chemical
composition of products.
16. Quality assurance and quality control records;
27. Production and batch records;
18. Inventory logs or records;
19. Year-end import, production and inventory s” ri.s;
20 • Records regarding product rames , generic names and
company product code .;
21. DocuIents rslating to th process of preparing the P O(a
an4 iiocs, and the decision to initiat, the PtOI process.
22. Copies of the P Q1s and NOC5;
23. Copies of EPA ’s Acknowledgement of Receipt of the PJO s;
24. Records and memoranda relating to Mobay’. submissions to
EPA regarding the 3978 Initial T$C Inventory under
Section 8 (b) of TSCA and the 1986 inventory update under
TSCA S.ction 8(a).
000007
988l28 g 01 .LS3d X C I I!! NCIO d3 W0 9t:St 686T,6 ,8Ø

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3
25. ascords regardinq potential adverse health or
environmental effects, maintained pursuant to Section 8
of TSCA.
26. All other documents. reasonably related to the
investigation of the P W5 and NOC5 in question.
The duration of the entry, inspection, collection and copying
of documents shall be for a reasonable time to enable you to
complete those activities.
A prompt return of this warrant showing completion of the
entry, inspection collection and copying of these documents
contemplated hereby shall b made within 11’ — days of this
date, together with an inventory of any property removed from the
premises.
Dated this ______ day of g.zi4.......L, 1989.
L I 4& -
uniter sta MagistrTts
t )torbp cutup iM pecaltyoE
Ps3r )ur7 1 tat t Ilttb1flia atru p
______ XAL
Dats ______
90d 988428 9 OJ. IS3d XO.L III NOL d3 WQe 4.t:St 686t/6 ’8O

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Jonathan Allan
- chc ical Enginasr and
Enfoxcoa.nt Officer
Suicribed and sworn b•fore me this . day of
—g 1989.
7
I.s / )ah... I
Unitd States Kagistrats
000005

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Jonathan u.n, being duly sworn, deposes and says:
• am a Chemical Engineer and Enforcement Of ficer with the
United States Environmental Protection Agency (NEPAN). wy duties
includ• the investigation of potential violations of the federal
laws relating to the manufacture of chemical substances and the
preparation of enforcement cases involving those laws.
2. I an currently involved in an investigation involving
possible violations of the Toxic Substances Control Act, 15 U.S.C.
§ 2601-2654 (TSC ) by the Mobay Corporation, whose corporate
headquarters i. located in Pittsburgh, Pennsylvania. Mobay is a
wholly-owned subsidiary of layer AG, a West German firm. The
investigation involves certain chemical substances which Mob’ay
imports into the United States.
3 • Under Section 5 of TSCA a notice must be shaittad to EPA 1
at least 90 days before any new chemical substance is manufactured
in the United States. Pursuant to Section 3 of TSCA manufacture 1
includes importation. This notice, known as a “pre—aenufacture
notice or “PNN,’ must include certain enumerated information. In
addition, pursuant to section 5 another notice, known as a Nnotic.
of commenc,v !LtU or NOC, must be filed withI i. 30 days after a new
chemical substance is first manufactured or imported.
4. Through discussions with other EPA officials I have learned
that betwes Juns and December, 1988, EPA received a group of
approximately 40 PIWs from Kobay Corporation. EPA has subsequently
received WOCs for several substances referred to in these P1 111 5.
As discussed below, EPA now has reason to believe that some of the
80d 988 28 8 Oj .LS3d XO1 II! NO!O3 bd3 WOd 8t:St 686t’6 ’8O

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2
chemical substances which were included in these P!QI 5 and NOCs may
have been imported into the United States prior to Mobay’ s
submission of iws for them, in violation of TSCA. After
consultation with reliable sources of information, I believe that
certain substances which vera the subject of the PIWs and NO in
question were in fact contained in products marketed by Mobay in
the United States prior to 1988.
5. in 1978, when Mobay was required to submit to EPA
information regarding .11 chemical substances produced by it, Mobay
represented to EPA that a certain product lin, was essentially the
sane as products made by its competitors. A reliable source now
informs me that prior to 1988 Mobay told at least one potential!
customer that the product line was in fact mad. in a different
manner than compititors’ products, resulting in a different and
purportedly superior product. In addition, according to the same
source, this entir. group of products sold by Kobay prior to
1988 was unavailabl* to purchasers from early 1988 until after the
submission of thO qreup of PlQls in late 1988, after which Mobay
again made the product lin, available. Based upon my experience
as an investigator and enforcement officer, I believe that there
may a similar situation with other Mobay products.
6 • Based upon my experience as an investigator and .nfercment
officer, I believe that ther. are substantial questions regarding
all of the P W* submitted by Mobay between June and December, 1988,
and that a thorough investigation of documents in Mobay’s
0C0003
988l28 8 01. 1S d ‘<01 III N0TLJ F 4 L ifl 4-4 t ct t’ ?’QI

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3
possession rsgarding these PIC s and the substances to which they
referred is reasonably likely to reveal violations of TSC .
7. Through discuesion with my colleagues at EPA I have become
familiar with the Mobay Corporation corporat. headquarters, located
on Mobay Road in Pittsburgh, Pennsylvania. This facility contains
records regarding all aspects of Mobay’. operations, and im ths
facility at which import orders and other import arrangements are
accomplished. I bsliev. that many of the records which are
necessary to investigate the issues discussed abov. will be found
at said facility.
8. Based upon prior experience of EPA inspectors at said
facility, I believe that EPA is likely to encounter substantial
resistance in conducting an inspection of the magnitud. necessary
to investigate the issues discussed above. I believe that it is
likely that EPA inspectors will be refused entry to the facility
in the absenc. of an administrativ, search warrant.
9 • Based upon my .xperienc. as an investigator and enforcement
officer, there is substantial reason for concern that the documents
needed by EPA may be destroyed if they are not inspected, collected
and copied at the earliest possible date. If EPA presents itself
for inapsation vithout a warrant and is refused entry, there is
reason for concern that moms of th. documents sought may be
destroyed in the tins it takes to cons before the court and obtain
a warrant.
01d 9B9428 8 01 iS3d X0i III N0I0 W0 6t:St 6S6t’6 ’8

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EflIITED STATES DISTRICT COURT
FOR TEE WESTERN DISTRICT OF PENNSYLVANIA
IN THE MAI’rER OF: )
Environnental Protection Agency ) Docket No. hess. ff_j if, c.
Adainistrative Warrant )
)
APILX CATION FOR AUMINISTRATIVE SEAR WARRANT
NOW COEES the United States of Aaarica, on behalf of the
United States Environmental Protection Agency (“EPA), by and
through the United States Attorney for the Western District of
Pennsylvania, and applies for an administrative warrant to enter,
inspect, collect end copy documents at th. Nobay Corporation
Corporate Headquarters, Mobay Road, Pittsburgh, Pennsylvania. This
entry is for the purpose of investigation pursuant to the Toxic
Substances Control Act, 15 U.S.C. 2601—2654 (UTSCAN). The
document inspection, collection and copying is authorized under
TSCA Sections 8 and 11, 15 U.S.C. §1 2907, 2610. Approximately two
weeks will be required to complete the process of inspection,
collection and copying of documents.
Sections 8 and 11 of TSCA, 15 U.S.C. 5 2607, 2610 authoriz
EPA to conduct inspections which extend to records, files, paper’s,
processes, controls and facilities bearing on whether the
requir m.nta of TSCA have been complied with. Section 11 requires
that notice be given to the owner, operator or agent in charge of
the premises, but does not provide that such notice be given at any
specific time interval prior to the inspectidgI. Section 11 also
requires that certain information sought during the inspection be
described with reraonab].e specificity in the written notice,
including in relevant part financial data, sales data (other than
shipment data), and research data.
In support of this application the United States submits an
affidavit and a proposed warrant.
Respectfully submitted,
Cha ies D. Sheehy
Acting United States Attorney
__________ by_____________________________
Date Amy Hay
Assistant United States Attorney
00000 1
L d 988 Z8 9 C i .LS3d XCI III NCj 3 3 LT:St S86T,6 ,8e

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UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
IN THE MATYER OF: )
Environmental Protection Agency ) Docket No. r - . -i*’fft
Administrative Warrant )
)
A LZ TTON FOR ADMINISTRATIVE SEARCN WARRANT
NOW COXES the United States of America, on behalf of the
United States Environmental. Protection Agency (“EPA”), by and
through the United States Attorney for the Western District of
Pennsylvania, and applies for an administrative warrant to enter,
inspect, collect and copy documents at the Mobay Corporation
Corporate Headquarters, Mobay Road, Pittsburgh, Pennsylvania. This
entry is for the purpos. of investigation pursuant to the Toxic
Substances Control Act, 15 U.S.C. § 2601-2654 (“TSCA”). The
document inspection, collection and copying is authorized under
TSCA Sections 8 and 11, 15 U.S.C. § 2907, 2610. Approximately two
weeks will, be required to complete the process of inspection,
collection and copying of documents.
Sections 8 and 11 of TSCA, 15 U.S.C. § 2607, 2610 authorize
EPA to conduct inspections which extend to records, files, papers,
processes, controls and facilities bearing on whether the
requirements of TSCA have been complied vith. Section 11 requires
that notice be given to the owner, operator or agent in charge of
the premises, but does not provide that such notice be given at any
specific time interval prior to the inspection. Section 11 also
requires that certain information sought during the inspection be
described with rc sonab1e specificity in the written notice,
including in relevant part financial data, sales data (other than
shipment data), and research data.
In support of this application the United States submits an
affidavit and a proposed warrant.
Respectfully submitted,
Charles D. Sheehy
Acting United States Attorney
__________ by______________________________
Date Amy Hay —
Assistant United States Attorney
L@ d 989428 9 0.1. .LS3d 2 XOJ. I I I NO I O3 d3 WO Lt St 686t,6 ,’8g

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Jonathan Allen, being duly sworn, deposes and says:
1. I am a Chemical Engineer and Enforcement Officer with the
United States Environmental Protection Agency (“EPA”). xy duties
include the investigation of potential violations of the federal
laws relating to the manufacture of chemical substances and the
preparation of enforcement cases involving those laws.
2. I am currently involved in an investigation involving
possible violations of the Toxic Substances Control Act, 15 U.S.C.
§ 2601-2654 (TSCA) by the Mobay Corporation, whose corporate
headquarters is locat.d in Pittsburgh, Pennsylvania. !4obay is a
wholly-owned subsidiary of Bayer AG, a West German firm. The
investigation involves certain chemical substances which Mobay
importa into the United States.
3. Under 8ection 5 of TSCA a notice must be submitted to EPA
at least 90 days before any new chemical substance is manufactured
in the United $tatss. Pursuant to Section 3 of TSCA “manufacture”
includes importation. This notice, known as a “pre—manufacture
notice” or “ io ,” must include certain enumerated information. In
addition, pursuant to Section 5 another notice, known as a “notice
of commencement ’ or “NOC,’ must be filed within 30 days after a new
chemical substance is first manufactured or imported.
4. Through discussions with other EPA officials I have learned
that between June and December, 1988, EPA received a group of
approximately 40 P)OIs from Mobay Corporation. EPA has subsequently
received NOCs for several substances referred to in these P1*s.
As discussed below, EPA now has reason to believe that some of the
80d 988428 8 Di. lS9d 2 XCI. III N0ID3 d3 W0 d BT:ST 68St/G ,’8O

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2
chemical. substances which were included in these PMNs and NOCs may
have been imported into the United States prior to Mobay’s
submission of PO s for them, in violation of TSCA. After
consultation with reliable sources of information, I believe that
certain substances which were the subject of the PIWs and NOCs in
question wan, in fact contained in products marketed by Mobay in
the United States prior to 1988.
5. In 1978, when Mobay was required to submit to EPA
information regarding all chemical substances produced by it, Mobay
represented to EPA that a certain product line was essentially the
same as products made by its competitors, A reliable source now
informs me that prior to 1988 Mobay told at least one potential
customer that the product line was in fact made in a different
manner then competitors’ products, resulting in a different and
purportedly superior product. In addition, according to the same
source, m this entire group of products sold by Mobay prior to
1988 was unavailable to purchasers from early 1988 until after the
submission of the group of PMNs in late 1988, after which Mobay
again made the product Line available. Based upon my experience
as an investigator and enforcement officer, I believe that there
may a similar situation with other Mobay products.
6. Based upon my experience as an investigator and enforcement
officer, I believe that there are substantial questions regarding
all of the PlOls submitted by Mobay between June and December, 1988,
and that a thorough investigation of documents in Mobay’s
60d 988 28 9 01 iS3d X01 III NOTtJ3?J I d t i0 i-i T:ct

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3
possession regarding these P Ws and the substances to which they
referred is reasonably likely to reveal violations of TSCA.
7. Through discussions with my colleagues at EPA I have become
familiar with the Mobay Corporation corporate headquarters, located
on Mobay Road in Pittsburgh, Pennsylvania. This facility contains
records regarding all aspects of Mobay’s operations, and is the
facility at which import orders arid other import arrangements are
accomplished. I believe that many of the records which are
necessary to investigate the issues discussed abov. will be found
at said facility.
8. Based upon prior experience of EPA inspectors at said
facility, I believe that EPA is likely to encounter substantial
resistance in conducting an inspection of the magnitude necessary
to investigate th. issues discussed above. I belie”. that it is
likely that EPA inspectors will b refused entry to the facility
in the absenc. of an administrativ . search warrant.
9. Based upon my experience as an investigator and enforcement
officer, there is substantial reason for concern that the documents
needed by EPA may be destroyed if they are not inspected, collected
and copied at the earliest possible data. If EPA presents itself
for inspction without a warrant and is refused entry, there is
reason for concern that some of the documents sought may b
destroyed in the time it takes to con. before the court and obtain
a warrant.
0Td 988 Z8E8 01 .LS3d 8 XO1 III N0I03 WO d 6t:St 686T/6 ,9@

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4
Jonathan Allen
Chemical Engineer and
Enforcement Officer
Suscrjbed and sworn before me thie ______ day of
___________, 1989.
, i )a1 4
United States Magistrate

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UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OP PENNSYLVANIA
IN THE MATTER OF: )
)
Environmental Protection Agency ) Docket No. Mee. i t
Administrative Warrant )
)
WARRANT AUTHORIZING ENTRY, INSPECTION,
COLLECTION, AND COPYING OP DOCUMENTS
PURSUANT TO the Toxic Substances Control Act (TSCA) • 42 U.S.C.
H 2601—2654;
TO: Mr. K. K. Wu and Mr. Jonathan Allen, United States
Environmental protection Agency (“EPA”), Region III • and any
authorized attorney or representative of said Agency or any other
agency of the Federal Government;
Application for entry, inspection, collection and copying of
documents having been made and applicant having demonstrated
through application and affidavit of Mr. Jonathan Allen, EPA Region
III , that the issuance of this warrant is constitutional, based
upon a right of entry authorized by statute, and is based upon the
reasonabl. belief that violations of TSCA may be discovered, and
other sufficient cause for the issuance of this warrant having been
demonstrated by such application and supporting affidavit and this
officer therefore having been satisfied that this warrant is
properly issued;
WHEREFORE, you are hearby authorized to enter the premises of
Mobay Corporation, Corporate Headquarters, Mobay Road, Pittsburgh,
Pennsylvania, at reasonable hours of the day, commencing July 5,
1989 and continuing for fourteen days or until further action by
this court, for the purpose of inspection, collection and copying
of documents, pursuant to TSCA. This authority shall extend to all
documents regarding various substances which were the sub cct of
certain pri—manufacture notices ( P Q1aN)and Notices of commencement
(“NOCs”), and products which may have contained these substances,
including, but not limited to, dyes, pigments, coatings, ion-
exchange raina and coagulants. The documents to be inspected,
collected and copied include:
1. Documents relating to Mobay Corporation’s zecordkeepinq
policies.
2. Import Certifications under Section 13 of TSCA and
documents relating to the preparation of such
certificates;

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2
3. U.S. customs Service Consumption Entry Forms and Entry
Summaries, and any related forms.
4. Import Invoices and Purcahse Orders;
5. Intercompany order records, transfer records and payment
records;
6. Intracompany order records, transfer records and payment
records;
7. Sales memoranda, orders, bills and invoices;
8. Shipping records;
9. customer lists and accounts;
10. Product literature and catalogs;
11. Material Data Safety Sheets;
12. Formulation records;
13 • Product specification records;
14. Chemical. composition records;
15. - Correspodence, notes and memoranda regarding chemical
composition of products.
16. Quality assurance and quality control records;
17. Production and batch records;
18. Inventory logs or records;
19. Year-end import, production and inventory s ” ries;
20. Records regarding product names , generic names and
company product codes;
21. Documents relating to the process of preparing the P)*ls
and NOCs, and the decision to initiat, the P Q process.
22. Copies of the P O4s and NOCs:
23. copies of EPA’S Acknowledgement of Receipt of the P * s;
24. Records and memoranda relating to Mobay’ a submissions to
EPA regarding the 1978 Initial TSCA Inventory under
Section 8(b) of TSCA and the 1986 inventory update under
TSCA Section 8(a).
Sø d 988228 8 01 IS3d XC I I II N0I0 WO 91: SI 68Gt ’6 ,Be

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3
25. Records regarding potential adverse
environmental effects, maintained pursuant
of TSCA.
health or
to Section 8
related
question.
to the
The duration of the entry,
of documents shall be for a
complete thos. activities.
inspection, collection and copying
reasonable time to enable you to
A prompt return of this warrant showing completion of the
entry, inspection collection and copying of these documents
contemplated hereby shall be made within fir — days of this
date, together with an inventory of any property removed from the
premises.
Dated this
j 9 )Li ) daY of ____
1989.
I haroby cettlfy wtdi’ paMity OS
D. rJury 1 that tk• vithin ia a ti’i&s
and orrot ooy o tha o ’18 1 1m1
U ftli4.
, sI L.
Un t sta Mag strate
26. All other documents reasonably
investigation of the PMNs and MOCs in
988228 9
01 .LS3d 8 XCI I II NC! D3 3 W0 : St 6G6t,6 ,eg

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Return oLSearch Wa raa
Docket No. 8914ax
1. Date of Warrant: Jun. 29, 1989
2. Dates Warrant executed: Warrant was executed on July 5, 6,
1 12, 13, and 14, 1989.
3. A certified copy of the warrant was given to Mr. Francis
Rattay and Mr. Spencer Nunley, both of Mobay Corporation, on
July 5, 1989.
4 An inventory of documents taken and copied was mad . in the
presence of Mr. Francis Rattay and Mr. Robert Sankaton, both
of Mo ay Corporation. Mr. Rattay also signed TSCA Receipt
for samples and Documents forms for the documents taken and
copied.
5. A total of approximately 568 documants were either taken or
copied on site. These documents measure approximately l 8 . 5 n
x 8.5” x 1]’.
6. The original documents taken from the site an, mainly Mobay
product information publications which are generally
available to the public. The documents taken are as
follows:
Prg uct In rmat ion
- Bonding Agent Additive ICA—9128 Product Information
- Lewatit/Levasorb: Ion Exchange Resins and Catalysts
Product Information (3-ring binder)
- Nydur A, AXV, and 5KV Product Information
- Roskydal 500k Product Informatioit
Vulkacit KA—9324 Product Information
? roduct References
-‘ Acramin Pigments: Nonionic and Anionic Pigments for
Textile Printing
- L .vatit/Levasorb: Ion Exchange Resins for Industry and the
Hone
- Maczolax: Dyes for Plastics
- Raw Materials for High Performance coatings: Product Index
- The Chemistry of Polyurethane Coatings: A General
Reference Manual
Otb Documents
- Bayer USA: Annual Report 1988
- Computer printout of liquidated and nonliquidated customs
entries (SALE52OI. REPORT)
- Mobay Corporation organization Plan, February 3.988
- Mobay Facts booklet
?O d 988L 8 8 OJ. iS3d I XOJ. 11! NOI J3 WO j P :ST S86 ’6 ’8O

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2
I swear that this inventory is a true and detailed account of the
property taken by me n this warrant. , / /
,.---. ,.J / 1., /

JonAthan 0. Allen
EP Enforc. ent off ic.r
Subscribed, sworn before me, and returned to me on this date
7/2 7/i ’3 ___ .
Date U.S. Magistrate
£ d 988 2B29 0.1. .LS3d 3 XOj. 111 N0I93 WQ St:ST 686L’5 ,BØ

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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF FLORIDA
IN THE MATTER OFI )
)
Basso Chemical Inc., ) Application for Warrant
3211 Powers Avenue ) to Enter, Inspect and Samp.
Jacksonville, FL 32207 ) Pursuant to Section 11, of
) the Toxic Substances Contri
) Act, 15 U.S.C. Section 261(
)
CO1 ES NOW the Administrator of the United State.
Environmental. Protection Agency (EPA), by and through U.S.
Attorney, and applie, for a warrant pursuant to and accordance
with Section 12. of the Toxic Substances Control Act, 15 U.S.C.
S2610, for the purpose of enabling duly authorized EPA
enforcement personnel to enter upon the premises of and to
conduct an administrative inspection of Basso Chemical Inc., of
Jacksonville, Florida as follows.
To inspect all. processes, operations, and facilities; to
inspect and s.Lzs and/or copy all records, files and papers
regarding manufacture, processing, distribution, sal.,
packaging, transportation, storage and/or disposal of chemical
substances associated with the premise.; and to inspect and
sample any or all chemical substances or mixtures within the
premises or in/on conveyances used to transport such chemical
substances or mixtures at or near the premises to determine
whether th• requirements of the Toxic Substances Control Act
appitcabi. to the facility and/or th. chemical substances and
mixtures hay, been complied with.

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—2-
This warrant is Sought under Section 11 of the Toxic
Substances Control Act, 15 U.S.C. 5 2610 which provides, in
pertinent part 2
(a) In Gen.ral. For purposes of adiuinist.rin
this Act, the Administrator, end any duly designate
representative of the Administrator, may inspect any
establishment, facility, or other premises in which
chemical substances or mixtures ar. manufactured,
processed, stored, or held before or after their
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 th. 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 during he period
covered by the inspection. 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) !xcept as provided in paragraph
(2), an inspection conducted under aubsectio (a) shall
extend to all things within the premises or conveyance
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 bs.n complied with.
(2) No inspection under Subsection (a) shall extend
to—..
(A) financial data
(8) sales data (other than shipment data),
(C) pricing data
(D) personnel data, or
(5) 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 resonabi. specificity in the written notic•
required by subsection for such insp.ction....

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—3—
Basso Chemical Inc. is engaged in the business of
manufacturing, processing, selling, distributing, storing and/or
disposing of chemical substance, and mixtures, as these term.
are defined in Section 3 of the Act.
This warrant is required in order to obtain information
necessary for EPA to adequately discharge its responsibilities
under the Toxic Substances Control Act, Section 313, 15 U.S.C.
_________ _________ and to ensure that —.
The inspection will be conducted at a reasonabi. time by
duly authorized enforcement officers of the U.S. !nvirorunental
Protection Agency, Region IV, as icon as practicabl. after
issuance of thi. warrant and will be of such duration as to
allow the inspectors to satisfactorily complete the inspection.
WHERSYORS, EPA requests that a warrant to enter, inspect,
and sample, and copying of records from the above-referenced
property be issued for the purposes stated herein.

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—4—
In support of this application, the Regional Administrator
respectfully submits th. accompanying affidavit and proposed
warrant.
Respectfully Submitted,
United States Attorney
By, — - —
Assistant U.S. Attorney
Northern District of Florida
Of Counsel.
Edwin Schwarts
Assistant Regional Counsel
U.S. Environmental Protection Agency
345 Courtland Street, LW.
Atlanta, Georgia 30365

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IN THE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
IN THE MATTER OP.
Basso Chemical Inc.
AFFIDAVIT IN SUPPORT OP
APPLICATION FOR WARRANj
STAT! OF FLORIDA
COUNTY OP DUVAL
Donald Stack being duly sworn upon his oath, according to
law, deposes and says.
1. I am a duly authorized enforcement officer of Region
IV, United States Environmental Protection Agency. I hereby
apply for a warrant pursuant to Section 11 of the Toxic
Substances Control Act (the Act), 15 U.S.C. 2610, for the
inspectiøit, copying, and sampling of th• items namöd below in
the possession, custody, or control of Basso Chemical Inc. on
the premises or in/on conveyances utilized in th. transport of
chemical substances or mixtures at or near the premises locatd
at 3211 Powers Avenue, Jacksonville, Florida.
To inspect all processes, controls, and facilities; to
inspect and copy all records, files, and papers; and to inspect
and eampi. any or all, chemical substances or mixtures wLthin the
premises or in/on conveyances utilized in the transport of
chemical substances or mixtures at or near th. premises bearing
on whether the requirements of the Toxic Substances Control Act
applicable to the chemical subetenc.. and mixtures hays been
complied with. The above data should include inspection of all
processes, controls, and facilities; inspection and copying of
all records, files, and papers bearing on or relating to the

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sale, handling, packaging, transportation, storage and/or
disposal of polycttlorirtated biphenyls(PCBs) in any form during
the periodof April 18, 1978 through the present; and inspection
and sampling of all PCB chemical substances, PCB mixtures, PCB
articles, and PCB containers located at the premises or in/on
conveyances utilized in the transport of chemical substance, or
mixtures at or near the premises.
2. This warrant is sought under Section 11 of the Act, 15
U.S.C. 2610, which provides in pertinent parts
SEC. 11 INSPECTIONS AND SUBPOENAS.
(a) In General.-—For purposes of administering this
Act, the Administrator, and any duly designated
representative of the Administrator, may inspect any
establishment, facility, or other premises in which
chemical substances or mixtures ax. manufactured,
processed, stored, or held before or after their
distribution in coimserce. Such an inspection may only
b. made upon th. presentation of appropriate
credentials and of a written notic. to the owner,
operator, or agent in charge of th. premise. or
conveyanc• to be inspected. A separate notice shall be
given for each such inspectton,b Ut a notice shall not
be required for each entry made during the period
covered by the inspection. Each such inspection shall
be caim encd and completed with reasonable promptness
and shall be conducted at reasonable times, within
reasonable limits, and in a reasonable manner.
(b) Scops.--.(l) Except as provided tn paragraph (2),
an inspection conducted under subsection (a) shall
extend to all thing. within th. premises or conveyance
inap.cted (including records, files, papers, processes,
controls, and facilities) bearing on whether the
requirements of this Act applicabl, to the chemical
substances or mixtures within such premises or
conveyance hev• been complied with. (2) No inspection
under subsection (a) shall extend to-.
(A) financial data,
(8) sales data (other than shipment data),
(C) pricing data,
(D) personnel data, or
(!) research data (other than data required by
this Act or under a rule promulgated there-
under),

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unless the nature and extent of such data are described
with reasonable specificity in the written notics
required by subsection (a) for such inspection...
3. Basso Chemical Inc. is engaged in the business of
manufacturing, processing, selling, distributing, and/or
disposing of chemical substances and mixtures.
4, This warrant is required in order to obtain
information necessary to -
5. The inspection will, begin as soon as practicable
after issuance of this warrant and will be conducted with
reasonable promptness but continuously and without interruption
until completed.
6. The enforcement officer may be accompanied by one
or more other employees of the United States Bnvironmental
Protection Agency.
7. Th• enforcement of fic.r requests immediate entry
to Basso Chemical Inc. to perform the inspection.
8. A return will be made to th. court at the
completion of the inspection.
9. The authority for the issuanc. of th inspection
warrant is Section 11 of ths Act, 15 U.S.C. 2610,
Barlow’s. Inc. , 98 8.Ct. 1816, — — ‘ “- ‘ • rf ‘r’’ ’
Donald Stack
Assistant Regionel Counsel
US !PA, Region IV

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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF FLORIDA
IN THE MATTER OFi
aseo Chemical Inc.
WARRANT FOR INSPECTION
DER T} TOXIC SUBS NCE CONTROL AC
To $
Donald Stack, Canton HaLley, and Jill Perry, Enforcement
Officers, U. S. Environmental Protection Agency, Region IV;
Application having been mad. and probable caus. shown, by the
U. 5. Attorney for the Northern District of Florida, for a
warrant to enter, inspect and sample the establishment described
ass
Saab Chemical Inc.
3211 Powers Avenue
Jacksonville, FL 32207
Pursuant to the Toxic Substances Control Act, 15 U.S.C. 2610,
and the decisione of the Supreme Court in Marshall V. arlow! s
Inc.. , 98 S.Ct.
1816, —— ——
______________ —
you are authorized to imeediately enter the above - described
premises upon presentation of this warrant at reasonable times
during business hours to inspect all processes, controls, and
facilities; to inspect and copy all records, files, and papers
regarding manufacture, processing, distribution, sal.,
packaging, transportation, storage and/or disposal of chemical
substances associated with the premises; and to inspect and
sample. any and/or all chemical substances or mixtures within the
premises or in/on any conveyance utilized in the transport of
chemical subitancea or mixtures at or near the premises to
determin, whether th. requirement. of the Toxic Substances
Control Act applicabi. to the facility and/or the chemical
substances or aixturee have been complied with.
rh. duration of th. inspection shall be of such a length as to
enable the above-named enforcement officers to utiefactorily
complete the inspection.
DATEDs ___________ - —
JUDGI
Inspection of the establishment described in this
warrant was completed on - — .

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S

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Washington, D.C.
INRE: )
)
BASF CORPORATION and ) Docket No. TSCA—87—H-05
RASP INMONT DIVISION )
)

________________)
AGREEMENT IN PRINCIPLE
In settlement of the above captioned matter, the parties
agree to the following specific terms and conditions to be in-
corporated into a Consent Agreement and Proposed Order of the
Administrator within ten (10) calendar days from the date of
execution of this agreement.
1. Implementation of a TSCA compliance program
f or all BASF Group Exports to the United States;
a specific description of the program to be in-
corporated into the Consent Agreement.
2. Initiation of a TSCA audit to determine the
compliance status of all chemical substances
imported by RASP into the United States, such
survey to be completed within 180 days of the
-entry of the Final Order. Violations of TSCA
discovered during the audit to be reported to
EPA in writing within ten (10) calendar days of
discovery. Stipulated penalties to be established
for each reporting deadline.
3. Development and implementation of a comprehensive
training program on TSCA compliance for all BASF
North American operations, as well a. appropriate
RASP Group companies worldwide.
4. Purchase of suitable advertisements in five national
trade publications promoting TSCA compliance, the
t•xt and selection of publications to be subject to
th. advance approval by EPA. Such approval will not
b unreasonably withheld.
5. Conduct of two seminars on TSCA compliance in West
Germany in conjunction with the West German
Manufacturing Association (VCI), with agendas,
attendance lists and summary reports to be provided
to EPA.

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—2—
6. Preparation and implementation of a corporate—wide
TSCA compliance manual providing detailed guidelines
for indivduals routinely involved with TSCA issues.
A copy of the manual to be provided to EPA.
7. Submission of a final audit report within 210
days of entry of the Final Order. For violations
disclosed within the timeframe provide in paragraph
2 above, involving chemicals or chemical substances
under TSCA Sections 5, 8, or 13 that do represent
a substantial risk to health or the environment,
BASF will pay the sum of $10,000 per chemical or
chemical substances as a maximum stipulated
penalty. For any chemicals or chemical substances
not reported within ten days or for chemicals
that represent a substantial risk to health or
the environment under Sections 5, 6, 8 or 13 of
TSCA, EPA reserves the right to seek a penalty in
accord with its published guidelines. Stipulated
penalties to be provided for each deadline.
8. EPA reserves its right to initiate administrative
or judicial enforcement action under TSCA Sections
7 or 17 to abate an imminent and substantial en—
dangerment to human health or the environment.
9. BASF will certify that it has achieved compliance
with TSCA within 240 days of entry of the Final
Order.
10. Within 20 days of the enrty of the Final Order,
BASF will pay a civil penalty of $1,281,950 for
the violations recited in the complaint.
FOR COMPLAINANT, U.S. EPA FOR RESPONDENT BASF CORPORATION
DATED:

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T

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- UNITFD STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter
of
)
3-V CHEMICAL
CORPORATION
)
Charlotte, NC
)
Responde
nt,
)
Docket No. TSCA 89-H—17
Notice of Treatment of Confidential Business Information
Portions of the attached Complaint require use of information
which Respondent submitted to the United States Environmental
Protection Agency (EPA) as Confidential Business Information (CBI).
Information in the Complaint constituting or based on CBI has
been deleted as indicated by the following: (CBI deleted). The
original complaint containing C I is filed with the Headquarters
Hearing Clerk. It will itself be treated as confidential unless
Respondent waives confidentiality thereto or EPA releases the
information in accordance with 40 C.F.R. Part 2.

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter
oft-
)
3-V CHEMICAL
CORPORATION
)
Charlotte, NC
)
Responden
t,
)
Docket No. TSCA—89—H—17
COMPLAINT AND NOTICE OF
OPPORTUNITY FOR HEARING
UNDER SECTION 16(a) OF
THE TOXIC SUBSTANCES
CONTROL ACT
COMPLAI NT
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Control Act,
15 U.S.C. 2601 et !S• (hereinafter “TSCA”). The Complainant is
Michael F. Wood, Director, Compliance Division, Office of
Compliance Monitoring, Office of Pesticides and Toxic Substances,
United States Environmental Protection Agency (EPA), who has been
duly delegated the authority to institute this action. The
Respondent is the 3-V Chemical Corporation, 7422 Carmel Executive
Park, Charlotte, NC 28226.
This Complaint serves as notice that Complainant has reason
to believe that Respondent manufactured (imported) and used for
commercial purposes chemical substances in violation of Section 5
of TSCA, 1.5 U.S.C. SectIon 2604, Section 13 of TSCA, 15 U.S.CI.
Section 2612, Section 4 of TSCA, 15 U.S.C. Section 2603, Section
12 of TSCA, 15 U.S.C. Section 2611, and Section 15 of TSCA, 15
U.S.C. Section 2614, as follows:

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—2—
COUNT I
1. On or about (CBI deleted), Respondent submitted a
Premanufactute Notification (PMN), subsequently identified
as PMN (CBI deleted) , to the EPA for the chemical substance,
(CBI deleted), hereinafter designated as Chemical A.
2. On (CBI deleted), Respondent provided EPA with records
revealing that Respondent had manufactured (imported)
Chemical A prior to their submission of the PMN.
3. An examination of Respondent’s submitted information
revealed that beginning on (C8I deleted), and continuing
to (CBI deleted), Respondent imported Chemical A on (CBI
deleted) different days. The total importation during this
period was (CBI deleted).
4. Information provided to EPA by the Respondent revealed that
the chemical substance mentioned in Paragraph 1 was
manufactured (imported) for use in the production of
(CBI deleted).

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—3—
5. During the period between (CEI deleted) and (CBI deleted),
Chemical A did not appear on the list of chemical
substances ul’aintained by the Administrator pursuant to 15
u.s.c. 2607. On (CBI deleted) Respondent submitted to
EPA a Notice of Commencement (NOC) for Chemical A. The NOC
for Chemical A was received and placed on the TSCA Inventory
by the EPA on (CBI deleted)
6. Respondent imported the chemical substance and is considered
a manufacturer under Section 3(7) of TSCA, 15 U.S.C.
2602(7).
‘. Respondent failed to submit a notice to the Administrator of
EPA of its intention to manufacture (import) Chemical A
during the period stated in Paragraph 3.
8. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a) (1), provides that
no person may manufacture (import) a chemical substance
which does not appear on the TSCA Chemical Substance
Inventory without submitting a notice to the Administrator
of EPA at least 90 days before manufacturing (importing)
such substance, Section 15(1) (B) of TSCA, 15 U.S.C.
2614(1) (B), provides that it is unlawful for any person to
fail to comply with any requirement prescribed by Section 5.

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—4—
Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3) (B), provides
that it is unlawful for any person to fail to submit
information required by the Act.
9. Respondent is a “person” within the meaning of 40 CFR Part
720.3(x). 40 CFR Part 720 sets forth EPA ’s regulations
regarding TSCA Section 5(a)(l) Premanufacture Notification.
10. The conduct described in Paragraphs 2 through 7 above was in
violation of Section 5(a)(1), Section 15(l)(B), and Section
15 (3) (B) of TSCA in that Respondent failed to submit a
notice to the Administrator of EPA at least 90 days before
manufacture (import) of the chemical substance as required.

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—5—
COUNT II
11. Paragraphs 1 and 2 of Count I are incorporated and
realleged, as if fully set forth herein.
12. An examination of Respondent’s submitted information
revealed that beginning on (CBI deleted) and continuing
to (CBI deleted), Respondent imported Chemical A on (CBI
deleted) different days and furnished a written statement to
the U.S. Customs Service certifying that Chemical A was not
being offered for entry in violation of TSCA.
13. During the period stated in Paragraph 12, Chemical A was not
on the TSCA Inventory of Chemical Substancese Chemical A
was not placed on the TSCA Inventory until (CBI deleted),
which is the date EPA received Respondent’s NOC for
PMN (CBI deleted).
14. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a) (1), provides that
no person may manufacture (import) a chemical substance
which doe8 not appear on the TSCA Chemical Substance
Inventory without submitting a notice to the Administrator
of •EPA at least 90 days before manufacturing (importing)
such substance.

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—6—
5. Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the
Secretary of the Treasury to issue rules for the
administrati9.n of Section 13(a) which provides for the entry
of chemical substances into the customs territory of the
United States. The Customs rule at 19 CFR Part 12, Sections
12.118 through 12.127, issued under Section 13(b) provides
that the importer of a chemical substance shall certify to
the district director at the port of entry that the chemical
substance being offered for entry is not: subject to TSCA;
or in violation of TSCA or any applicable rule thereunder.
16. Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3) (B), provides
that it is unlawful to fail to submit information as
required by this Act or rule thereunder.
17. Respondent’s certification to the district director at the
port of entry that Chemical A was not in violation of TSCA
did not represent the true compliance status of Chemical A.
18. The conduct described in Paragraphs 11 through 13 above was
in violation of Section 13(b) and Section 15(3)(B) of TSCA,
in that Respondent failed to submit a certification to the
district director at the port of entry adequately
representing the true compliance status of Chemical A, as
required.

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—7—
COUNT III
19. Section 4 of ‘1’SCA, 15 U.S.C. 2603, authorizes EPA to require
manufacturers (including importers) and/or processors of
identified chemical substances and mixtures to test
chemicals to develop health and environmental effects data.
20. On October 10, 1904, EPA promulgated a final Phase I test
rule for l,1,l—trichloroethane (CAS # 71—55—6), 40 CFR Part
799.4400. The rule became effective on November 23, 1984.
21. 40 CFR Part 799.4400(c) requires that (aill persons who
manufacture (import) or process l,],l—trichloroethane...from
November 23, 1984, to the end of the reimbursement period
shall submit letters of intent to test, exemption
applications...and shall conduct tests and submit data as
specified in this section, Subpart A of this part and Part
790 of this chapter....
22. The end of the reimbursement period is considered by the
Agency to be five years after the last final report is
submitted or an amount of time equal to that which was
required to develop data if more than five years after the
submission of the last final report required under the test
rule. The last final report for l,l,l—trichloroethane was
received by the EPA on June 30, 1987.

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—8—
3. 40 CFR Part 790.45(a) provides that no later than 30 days
after the effective date of a test rule described in 40 CFR
Part 790.40, each person subject to that rule and required
to comply with the requirements of that rule as provided in
40 CFR Part 790.42(a) must, for each test required, either
notify EPA by letter of his or her intent to conduct testing
or submit an application for an exemption from testing
requirements for he test.
24. 40 CFR Part 790.45(d) (1) provides that any person who was
not manufacturing (importing) or processing the subject
chemical as of or within 30 days of the effective date of
the test rule, must submit the letter of intent to test or
exemption application by the date manufacture (importing)
or processing begins.
25. On or about November 15, 1985, Respondent imported into the
United States 37,478 lbs . of 1,1,1—trichioroethane.
Respondent did not submit an application for exemption from
the testing required by 40 CFR Part 799.4400 and 40 CFR Part
790.45(d) (1).
26. OnAugust 6, 1987, Respondent provided EPA with an
application for exemption from testing for the chemical
substance, 1,1,1—trichioroethane.

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—9—
27. Respondent’s late submission of the application for
exemption from testing, as alleged in Paragraph 25 above,
constitutes a failure or refusal to comply with 40 CFR Parts
790.40, 79.0.45, and 799.4400, which is a violation of
Section 4 and Sections 15(1) (A) and 15(3) (B) of TSCA.
COUNT IV
28. Paragraph 19 of Count III is incorporated and realleged, as
if fully set forth herein.
29. On May 23, 1985, EPA promulgated a final Phase I test
rule for Diethylenetriamine (DETA) (CAS * 111—40—0) , 40 CFR
Part 799.1575. The rule became effective on July 8, 1985.
30. 40 CFR Part 799.1575(b) requires that (aill persons who
manufacture (import) or process diethylenetriamine...from
July 8, 1985, to the end of the reimbursement period
shall submit letters of intent to test, exemption
applications...and shall conduct tests and submit data as
specified in this section, Subpart A of this part and Part
790 of this chapter....

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— 10 —
31. The end of the reimbursement period is considered by the
Agency to be five years after the last final report is
submitted or an amount of time equal to that which was
required to develop data if more than five years after the
submission of the last final report required under the test
rule. The last final report for diethylenetriamine has not
been submitted to the EPA as of the date of this Complaint.
32. 40 CFR Part 790.45(a) provides that no later than 30 days
after the effective date of a test rule described in 40 CFR
Part 790.40, each person subject to that rule and required
to comply with the requirements of that rule as provided in
40 CFR Part 790.42(a) must, for each test required, either
notify EPA by letter of his or her intent to conduct testing
or submit an application for an exemption from testing
requirements for the test.
33. 40 CFR Part 790.45(d) (1) provides that any person who was
not manufacturing (importing) or processing the subject
chemical as of or within 30 days of the effective date of
the test rule, must submit the letter of intent to test or
exemption application by the date manufacture (Importing)
or processing begins.

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— 11 —
34. On or about September 25, 1985, Respondent imported into the
United States 9,524 lbs . of (DETA). Respondent did not
submit an application for exemption from the testing
required by 40 CFR Part 799.1575 and 40 CFR Part
790.45 Cd) (1)
35. On August 6, 1987, Respondent provided EPA with an
application for exemption from testing for the chemical
substance, (DETA).
36. Respondent’s late submission of the application for
exemption from testing, as alleged in Paragraph 34 above,
constitutes a failure or refusal to comply with 40 CFR Parts
790.40, 790.45, and 799.1575, which is a violation of
Section 4 and Sections 15(l)(A) and 15(3)(B) of TSCA.
COUNT V
37. Section 12(b) of TSCA, 15 U.S.C. 2611 and 40 CFR Part
707.60, requires any person who exports or intends to export
to a specific foreign country a chemical substance or
mixture subject to certain actions pending under Sections 4,
5, 6, or 7 of TSCA, to submit a 12(b) export notice to the
EPA as required.
a

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— 12 —
38. Under 40 CFR Part 707.65, this notice must be for the first
export or intended export to a particular country in a
calender year, and must be postmarked within seven days of
forming the intent to export or on the date of export,
hichever is earlier.
39. Under 40 CFR Part 707.67, the notice must include: the name
of the chemical, the name and address of the exporter, the
country of export, the date of export, and the applicable
section of TSCA.
40. Paragraphs 19 and 20 of Count III are incorporated and
realleged, as if fully set forth herein.
41. On or about (CBI deleted), Respondent submitted to EPA a
12(b) export notice, listing the exports from (CBI deleted)
through (CBI deleted), for a product that contained a
chemical substance, 1,1,1—Trichioroethane, that is
regulated under Section 4 of TSCA.
42. Respondent’s failure to submit the 12(b) export notice as
required under 40 CFR Parts 707.60 and 707.65 is a violation
of Section 12 and Section 15(3)(B) of TSCA, 15 U.S.C.
2614 (3) (B).

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— 13 —
PROPOSED CIVIL PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this
Complaint, and upon the nature, circumstance, extent and gravity
of the violations alleged, as well as Respondent’s history of
prior violations of TSCA, the degree of culpability and such
other matters as justice may require, the Complainant proposes
that Respondent be assessed the following civil penalty for the
violations alleged in the Complaint:
COUNT I
Failure to notify of intention to
manufacture (import) a chemical
substance not on the TSCA Inventory...............$ 50,000
15 U.S.C. 2604(a) (1)
15 U.S.C. 2614(1) (B)
15 U.S.C. 2614(3) (B)
COUNT II
Failure to provide a certification statement
to the district director at the port of entry
adequately representing the true compliance status
ofachemicalsubstance...........................$ 50,000
15 U.S.C. 2604(a) (1)
15 U.S.C. 2612(b)
15 Li.S.C. 2614(3) (B)

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— 14 —
COUNT III
Failure to submit letter of intent to
test or a valid request for exemption
from testingas required..........................$ 25,000
15 U.S.C. 2603(c)
15 U.S.C. 2614(1) (A)
15 U.S.C. 2614(3) (B)
COUNT IV
Failure to submit letter of intent to
test or a valid request for exemption
from testing as required.................. $ 25,000
15 U.S.C. 2603(c)
15 U.s.c. 2614(1) (A)
15 U.S.C. 2614(3) (B)
COUNT V
Failure to submit a 12(b) export notice as
required..... .. .. .. . . . .... .. . . .. .. . . .... . . ........$ Notice of
- Noncompliance
15 U.S.C. 2611
15 U.S.C. 2614(3) (B)
TOTALS...... . . . . . . . . . . . . .$ 150,000

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— 15 —
ADJUSTMENTS TO PROPOSED PENALTY
Because Respondent voluntarily disclosed to EPA the
violations alleged in the Complaint, Complainant is adjusting the
proposed penalty downward twenty—five percent.
ADJUSTED TOTAL PROPOSED CIVIL PENALTY ......$ 112,500
NOTICE OF OPPORTUNITY TO
REQUEST A HEARING
As provided in Section 16(a) (2) (A) of TSCA, and in
accordance with 554 of Title 5, United States Code, you have the
right to request a formal hearing to contest any material fact
set forth in this Complaint or to contest the appropriateness of
e proposed penalty. To avoid being found in default and having
the above—cited penalty assessed without further proceedings, you
must file a written Answer within twenty (20) days of your
receipt of this Complaint. Your Answer should (1) clearly and
directly admit, deny, or explain each of the factual allegations’
contained in this Complaint, (2) briefly state all facts and
circumstances, if any, which constitute grounds for a defense,
and (3) specifically request an administrative hearing (if
desired). The denial of any material fact or the raising of any
affirmative defense shall be construed as a request for a
hearing. Failure to deny any of the factual allegations in this
Complaint will constitute an admission of the undenied
allegations. The Answer should be sent to:

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— 16 —
Headquarters Hearing Clerk (A—hO)
United States Environmental
Protection Agency
401 M Street, S.W., Room 3706
WashIngton, DC 20460
The hearing which will be held upon your request will be
conducted in accordance with the Administrative Procedure Act
(5 U.S.C. Section 551 et seq. ) and the “Consolidated Rules of
Practice Governing the Administrative Assessment of Civil
Penalties and the Revocation or Suspension of Permits” 40 CFR
Part 22 (45 FR 24360). A copy of the Consolidated Rules
accompanies this Complaint.
INFORMAL SETTLIEMENT CONFERENCE
Whether or not you request a hearing, you may confer
informally with EPA to discuss the facts of this case, or amount
of the proposed penalty, and the possibility of settlement. An
informal settlement conference does not, however, affect your
obligation to file a written Answer to the Complaint.
EPA has the authority to modify the amount of the proposed
penalty, where appropriate, to reflect any settlement reached
with you in an informal conference. The terms of such an
agreement would be embodied in a Consent Agreement and Final
Order. A Consent Agreement signed by EPA and yourself would be
binding as to all terms and conditions specified therein.

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— LI —
Any requests for an informal conference, copies of all
1 ocuments to be filed by Respondent, including the Answer, and
any other questions that you may have regarding this Complaint
should be directed-to:
Mr. Vincent Giordano, Attorney
Toxics Litigation Division
(LE—134—P)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460
(202) —475—8693
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or
requesting an informal settlement conference, you may choose to
ay the proposed penalty. Such payment should be made by
sending to the Headquarters Hearing Clerk’s address listed below
a cashier’s or certified check in the amount of the penalty
assessed in this Complaint. Your check must be made payable to
the United States of America and sent to:
EPA—Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251
.

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— 18 —
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
TSCA 89—H—17
Complainant
BY.: 1 A
/ k ” 1
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring
Date: _________________

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— 19 —
CERTIFICATION
I hereby certifythat the original of the foregoing Complaint and
Notice of Opportunity for Hearing, Docket No. TSCA—89—H—17, has
been filed with the Headquarters Hearing Clerk and that copies
were sent, registered mail, return receipt requested to:
Mr. Michael R. Cusano, General Manager
3-V Chemical Corporation
7422 Carmel Executive Park
Charlotte, NC 28226
iL /I / cLc L
Date John E. Mason (EN—342)
Document Control Officer
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
C.,.
IN THE MATTER
OF:
)
TPEMCO, INC.
)
INCON DIVISION
)
BARROURVILLE,
KENTUCKY
)
Respondent.
)
Docket No. TSCP 88-H-05
Notice of Treatment of Confidential Business Information
Portions of the attached Second Amended Complaint require
use of information which Respondent submitted to the United
States Environmental Protection Agency (EPA) as Confidential
Rusiness Information (CR1). Information in the Complaint
constituting or based on CBI has been deleted as indicated by
the following: (CR1 deleted). The original Second Amended
Complaint which contains CR1 is filed with the Headquarters
Hearing Clerk. It will itself he treated as confidential unless
Pespondent waives confidentiality thereto or EPA releases the
information in accordance with 40 C.F.R. Part 2.

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
IN THE MATTER
OF:
)
TREMCO, INC.
)
INCON DIVISION
)
BARBOURVILLF,
KENTUCKY
)
Respondent
)
)
Docket No. TSCA—8 -H—Q5
COMPLAINT AND NOTICE OF
OPPORTUNITY FOR HEARING
UNDER SECTION 16(a) OF
THE TOXIC SUBSTANCES
CONTROL ACT
SECOND AMENDED COMPLAINT
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Control Act,
1 u.s.c. 2601 et (hereinafter “TSCA”). The Complainant
is Connie P. Musgrove, Chief Executive Officer, Office of Compliance
Monitoring, Office of Pesticides and Toxic Substances, United
States Environmental Protection Agency (hereinafter “EPA or “the
Agency), who has been duly delegated the authority to institute
this action. The Respondent is Tremco, Inc., Incon Division
Treuhaft Boulevard, Barhourville, Kentucky (hereinafter “Respondent”).
This seconded amended Complaint serves as notice that
Complainant has reason to believe that Respondent manufactured
chemical substances in violation of Section 5 of TSCA, 15
U.S.C. Section 2604, and Section 15 of TSCA, 15 U.S.C. Section
2614, as follows:

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-2—
COUNT 1
1. Respondent is included in the word “Person” as defined in
40 CFR 720.3(x) and as such is subject to TSCA and the
regulations promulgated thereunder.
2.. On (CR1 deleted), Respondent submitted information to
the Agency revealing that Respondent had manufactured
the chemical substance (CR1 deleted), hereinafter
known as Chemical A. Chemical A is designated by the
Respondent as (CBI deleted), and has also been designated
by the Agency as (CR! deleted).
3. On (CR! deleted), Respondent provided the Agency with
records covering the production of Chemical A. Based
upon this information, Complainant alleged in the
original Complaint that Respondent had manufactured
Chemical A on 22 separate daily occasions. These allegations
were previously alleged in the Complaint as Counts 1
through 22. However, in preparing its response to the
Complaint, Respondent determined that the information
which was supplied to the Agency in (CR1 deleted)
was incomplete. Additional documents reveal that
between (CBI deleted) Respondent had manufactured
chemical A on at least 41 separate daily occasions.

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—3—
4. on the dates of manufacture referred to In paragraph
3, Chemical A did not appear on the TSCA Chemical
Substance Inventory maintained by the Administrator
pursuant to Section 8 of TSCA, 15 U.S.C. 2607.
5. Section S(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides
that no person may manufacture a chemical substance
which does not appear on the TSCA Chemical Substance
Inventory, unless such person submits a Preiranufacture
Notice to the Administrator of EPA at least 90 days
before such manufacture. Respondent’s Prerianufacture
Notice for Chemical A was received by the Agency on
(CR! deleted). The statutory 90 day review period
for Chemical A expired (CR1 deleted).
6. Section l5(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provides
that it is unlawful for any person to fail or refuse
to comply with any requirement prescribed by Section
5 of TSCA.
7. The conduct described in paragraph 3 above was in
violation of ectlons 5(a)(1) and 15(l)(R) of TSCA,
in that Respondent failed to notify the Administrator
at least 90 days before the manufacture of Chemical A.

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—4—
COtINT 2
1. Respondent is included in the word “Person” as defined in
40 CFR 720 3(x). and as such is subject to TSCA and the
regulations promulgated thereunder.
2. On (CR1 deleted), Respondent submitted information to
the Agency revealing that Respondent had manufactured
the chemical substance (CBI deleted), hereinafter
known as Chemical B. Chemical R is designated by the
Respondent as (CBI deleted), and has also been designated
by the gency as (CR1 deleted).
3. On (CR1 deleted), Respondent provided the Agency with
records covering the production of Chemical B. Based
upon this information, Complainant alleged in the
original Complaint that Respondent had manufactured
Chemical B on 3 separate daily occasions. These allegations
were previously alleged in the Complaint as Counts 23
through 25. However, in preparing its response to the
Complaint, Respondent determined that the information
which was supplied to the Agency in (CR1 deleted)
was incomplete. Additional documents reveal that
between (CBI deleted) Respondent had manufactured
Chemical B on at least 14 separate daily occasions.

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—5-.
4. On the dates of manufacture referred to in paragraph
3, Chemical B did not appear on the TSCA Chemical
Substance- Inventory maintained by the Administrator
pursuant to Section 8 of TSC , 15 u.s.c. 2607.
5. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a)(1), provides
that no person may manufacture a chemical substance
which does not appear on the TSCA Chemical Substance
Inventory unless such person submits a Premanufacture
Notice to the Administrator of EPA at least 90 days
before such manufacture. Respondent’s Premanufacture
Notice for Chemical B was received by the Agency on
(CR1 deleted). The statutory 90 day review period
for Chemical R expired (CR! deleted).
6. Section ].5(l)(B) of TSCA, 15 U.S.C. 2614(l)(B), provides
that it is unlawful for any person to fail or refuse
to comply with any requirement prescribed by Section
5 of TSCA.
7. The conduct described in paragraph 3 above was In
violation of Sections 5(a)(1) and 15(1)(B) of TSCA,
in that Respondent failed to notify the Administrator
at least 90 days before manufacturing Chemical B.

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—6—
COUNT 3
1. Respondent is included in the word “Person” as defined in
4fl CFR 720.3(x) and as such is subject to TSCA and the
regulations promulgated thereunder.
2. On (CR1 deleted), Respondent submitted information to
the Agency revealing that Respondent had manufactured
the chenical substance (CR1 deleted), hereinafter
known as Chemical C. Chemical C is designated by the
Respondent as (CR1 deleted), and has also been designated
by the Agency as (CBI deleted).
3. On (CR1 deleted), Respondent provided the Agency with
records covering the production of Chemical C. Based
upon this information, Complainant alleged in the
original Complaint that Respondent had manufactured
Chemical C on 32 separate daily occasions. These allegations
were previously alleged in the Complaint as Counts 26
through 57. However, in preparing its response to the
Complaint, Respondent determined that the information
which was supplied to the Agency in (CR1 deleted)
was incanpiete. Additional documents reveal that
between (CR1 deleted) Respondent had manufactured
Chemical C on at least 54 separate daily occasions.

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—7—
4. On the dates of manufacture referred to in paragraph
3, Chemical C did not appear on the TSCA Chemical
Substance Inventory maintained by the Administrator
pursuant to Section 8 of TSCA, 15 U.S.C. 2607.
5. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a)(1), provides
that no person may manufacture a chemical substance
which does not appear on the TSCA Chemical Substance
Inventory, unless such person submits a Preinanufacture
Notifice to the Administrator of EPA at least 90 days
before such manufacture. Respondent’s Premanufacture
Notice for Chemical C was received by the Agency on
(CR1 deleted). The statutory 90 day review period
for Chemical C expired (CR1 deleted).
6. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(R), provides
that it is unlawful for any person to fail or refuse
to comply with any requirement prescribed by Section
5 of TSCA.
7. The conduct described in paragraph 3 above was in
violation of Sections 5(a)(1) and 15(1)(B) of TSCA,
in that Respondent failed to notify the Administrator
at least 90 days before manufacturing Chemical C.

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—8—
COUNT 4
1. Respondent is included in the word “Person” as defined in
40 CFR 720.3(x) and as such is subject to TSCA and the
regulations promulgated thereunder.
2. On or about (CBI deleted), an inspection of Respondent’s
facility located in Rarbourville, Kentucky was performed
by authorized employees of EPA pursuant to Section 11
of TSCA. The purpose of the inspection was to determine
Respondent’s compliance with TSCA €5 requirements.
3. As a result of the inspection, on (CR1 deleted),
Respondent provided EPA with additional information
covering the production of Chemical A.
4. The production records that Respondent provided to
the Agency reveal that on (CR1 deleted), Respondent
produced (CR1 deleted) of Chemical A for commercial
purposes.
5. On the date of manufacture referred to in paragraph
4, Chemical A did not appear on the TSCA Chemical
Substance Inventory maintained by the Administrator
pursuant to Section 8 of TSCA, 15 U.S.C. 2607.

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—9—
6. Section 5(a)(1) of TSCA, 15 U.S.C. 2604(a)(1), provides
that no person may manufacture a chemical substance which
does not appear on the TSCA Chemical Substance Inventory
unless such person submits a Premanufacture Notice to
the Administrator of EPA at least 90 days before such
manufacture. Respondent’s Preiranufacture Notice for
Chemical A was received by the Agency on (CR1 deleted).
The statutory 90 day review period for Chemical A
expired (CBI deleted). Respondent manufactured Chemical
A on (CR1 deleted).
7. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provides
that it is unlawful for any person to fail or refuse
to comply with any requirement prescribed by Section 5
of TSCA.
8. The conduct described in paragraph 4 above was in violation
of Sections 5(a)(1) and 15(1)(B) of TSCA, in that Respondent
failed to notify the Administrator at least 90 days
before manufacturing Chemical A. This allegation was
previously alleged in the Complaint as Count 58.

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— in —
COUNT 5
1—2. paragraphs 1 and 2 of Count 4 are hereby incorporated
by reference a if fully set forth in this Count.
3. As a result of the inspection, on (CR1 deleted),
Respondent provided EPA with additional information
covering the production of Chemical C.
4. The production records that Respondent provided to the
Agency reveal that on (CBI deleted), Respondent
produced (CBI deleted) of Chemical C for commercial
purposes.
5. On the date of manufacture referred to in paragraph
4, Chemical C did not appear on the TSCA Chemical
Substance Inventory maintained by the Administrator
pursuant to TSCA Section 8 of TSCA, 15 U.S.C. 2607.
6. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(1), provides
that no person may manufacture a chemical substance
which does not appear on the TSCA Chemical Substance
Inventory, unless such person submits a Premanufacture
Notice to the Administrator of EPA at least 90 days
before such manufacture. Respondent’s Premanufacture
Notice for Chemical C was received by the Agency on
(CR1 deleted). The statutory 90 day review-period

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— 11 —
for Chemical C expired (CBI deleted). Respondent
manufactured Chemical C on (CM deleted).
7. Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(R), provides
that it is unlawful for any person to fail or refuse
to comply with any requirement prescribed by Section 5
of TSCA.
8. The conduct described in paragraph 4 above was in
violation of Sections 5(a)(l) and 15(1)(B) of TSC ,
in that Respondent failed to notify the dministrator
at least 90 days before manufacturing Chemical C.
This allegation was previously alleged in the Complaint
as Count 59.
PROPOSED CIVIL PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes
the assessment of a civil penalty of up to S25,flOO per day
for each violation of TSCA. Based upon the facts alleged
in this Complaint, and upon the nature, circumstances,
extent and gravity of the violations alleged, as well as
Respondent’s history of prior violations of TSCA, the
degree of culpability, and such other matters as justice
may require, the Complainant proposes that Respondent be
assessed the following civil penalty for the violations
alleged in this Complaint:

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— 12 —
COUNT 1
Manufacture of a chemical substance on 41 separate daily
occasions which did not appear on the TSCA Chemical Substance
Inventory. •1• •••, •••• •1 •••••••• • •......... . . . . . . .S1 12,500
15 U.S.C. 2604(a)(l)
15 U.S.C. 2614(l)(B)
COUNT 2
Manufacture of a chemical substance on 14 separate daily
occasions which did not appear on the TSCA Chemical Substance
Inventory .. $ 38,000
15 U.S.C. 2604(a)(l)
15 U.S.C. 2614(1)(B)
COUNT 3
Manufacture of a chemical substance on 54 separate daily
occasions which did not appear on the TSCA Chemical Substance
Inventory. . . . . .......... . . . . ........... . . ....... .S106,500
15 U.S.C. 2604(a)(1)
15 U.S.C. 2 14(l)(R)
COUNT 4
Manufacture of a chemical substance which did not appear
on the TSCA Chemical Substance Inventory.........S 10,000
15 U.S.C. 2604(a)(l)
15 U.S.C. 2614(1)(B)

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— 13 —
COUNT 5
Manufacture of a chemical substance which did not appear
çn the TSCA Chemical Substance Inventc ry.........S 10,000
15 U.S.C. 2604(a)(l)
15 U.S.C. 2614’l)(R)
TOTAL PROPOSED PENALTY . ................ ... •1•• .S277,000
ADJUSTMENTS TO PROPflSEI) PENALTY
DJUSThENTS TO COUNTS 1 THROUGH 3.
Because Respondent voluntarily disclosed to EPA the
violations in Counts 1 through 3, Complainant is adjusting
the proposed penalty downward twenty—five percent.
M)JUSTED PROPOSED PENALTY FOR
COUNTS 1 THROUGH 3....... . . . . . . . . . . ........ . . . . . .5192,750
DJUST14ENTS TO COUNTS 4 AND 5.
Respondent’s past compliance history includes TSCA
Section 5 violations. See docket numbers: TSCA—83—H—07,
and Region V case number 409. Therefore, Complainant is
adjusting the penalty upwards for Counts 4 and 5 by 100%.
ADJUSTED PROPOSED PENALTY FOR COUNTS 4 and S.....S 40,000
TOTAL ADJUSTED PROPOSED PENALTY...... ...... ..... .$232,750

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— 14 —
NOTICE OF OPPORTUNITY TO
RECUEST A HEARING
As provided in Section 16(a)(2)(A) of TSCA, and in
accordance with-Section 554 of Title 5, United States Code,
you have the right to request a formal hearing to contest any
material fact set forth in this Complaint or to contest the
appropriateness of the proposed penalty. To avoid being
found in default and having the above—cited penalty assessed
without further proceedings, you must- file a written Answer
within twenty (20) days of your receipt of this Complaint.
Your Answer should (1) clearly and directly admit, deny, or
explain each of the factual allegations contained in this
Complaint, (2) briefly state all facts and circumstances, if
any, which constitute grounds for a defense, and (3) specifically
request an administrative hearing (if desired). The denial of
any material fact or the raising of any affirmative defense
shall be construed as a request for a hearing. Failure to
deny any of the factual allegations in this Complaint will
constitute an admission of the undenied allegations. The
Answer must be sent to:
Headquarters Hearing Clerk (A—llO)
United States Environmental
Protection Agency
401 M Street, S.W., Room 3706
Washington, DC 20460
The hearing which will he held upon your request will be
conducted in accordance with the Administrative Procedure Act

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— 15 —
(5 U.S.C. Section 551 et and the “Consolidated Rules of
Practice Governing the Administrative Assessment of Civil
Penalties and the Revocation or Suspension of Permits” 40 CFR
part 22 (45 FR 24360). A copy of the consolidated Rules
accompanies this Complaint.
INFORMAL SETTLFJAF.NT CONFERENCE
Whether or not you request a hearing, you may confer
informally with EPA to discuss the facts of this case, or amount
of the proposed penalty, and the possibility of settlement. An
informal settlement conference does not, however, affect your
obligation to file a written Answer to the Complaint.
EPA has the authority to modify the amount of the proposed
penalty, where appropriate, to reflect any settlement reached
with you in an informal conference. The terms of such an
agreement would be embodied in a Consent Agreement and Final
Order. A Consent Agreement signed by EPA and yourself would
be binding as to all terms and conditions specified therein.
Any requests for an informal conference, copies of all
documents to be filed by Respondent, and any other questions
that you may have regarding this Complaint should be directed to:
Mr. Vincent C iordano
U.S. Environmental Protection Agency
Toxics Litigation Division (LE—134P)
Room 113 Northeast Mall
401 14 Street, S .W.
Washington, D.C. 20460
(202) 475—8690

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— 16 —
PAYMENT OF PFNALTY
Instead of filing an Answer requesting a hearing or request-
ing an informal settlement conference, you may choose to pay
the proposed penalty. Such payment should be made by sending
to the Headquarters Hearing Clerk’s address listed below a
cashier’s or certified check in the amount of the penalty
assessed in this Complaint. Your check must he made payable
to the United States of America and sent to:
EPA—Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251
UNITED STATES
ENVIRONMENTAL PROTF.CTION AGENCY
Complainant
onn e A. Mus rove U
Chief Executive Officer
Office of Compliance Monitoring (EN—342)
NOV - 2 i988
Date: ___________

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of
GRIFFTEX CHEMICALS ) Docket No. TSCA 88—11—03
Respondent,
Notice of Treatment of Confidential Business Information
Portions of the attached Complaint require use of information
which Respondent submitted to the United States Environmental
Protection Agency (EPA) as Confidential Business Information (CBI).
Information in the Complaint constituting or based on CBI has
been deleted as indicated by the following: (CBI deleted). The
original complaint containing CBI is filed with the Headquarters
Hearing Clerk. It will itself be treated as confidential unless
Respondent waives confidentiality thereto or EPA releases the
information in accordance with 40 C.F.R. Part 2.

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of
)
GRIFFTEX CHEMICALS
)
Respondent,
)
Docket NO. TSCA-88--H-03
COMPLAINT AND NOTICE OF
OPPORTUNITY FOR HEARING
UNDER SECTION 16(a) OF
THE TOXIC SUBSTANCES
CONTROL ACT
COMPLAINT
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Control Act,
15 U.S.C. 2601 et sea. (hereinafter ?TSCA !). The Complainant
is Ken Shiroishi, Director, Compliance Division, Office of
Compliance Monitoring, Office of Pesticides and Toxic Substances,
United States Environmental Protection Agency (EPA), who has
been duly delegated the authority to institute this action.
The Respondent is Grifftex Chemicals, a facility of west Point
Pepperell, Inc., 1900 cunningham Drive, Opelika, Alabama 36801.
This Complaint serves as notice that Complainant has
reason to believe that Respondent manufactured a chemical
substance in violation of Section 5 of TSCA, 15 U.S.C. Section
2604, and Section 15 of TSCA, 15 U.S.C. Section 2614, as
follows:

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—2—
COUNT I
1. On June 26, 1986, Grifftex Chemicals, a facility of West
Point Pepperell, Inc., located at 1900 Cunningham Drive,
ODelika, Alabama, 36801 was inspected by a duly authorized
representative of EPA pursuant to Section 11 of TSCA, 15
U.S.C. 2610.
2. This inspection was conducted to determine compliance with
TSCA Section 5 and Section 8 requirements.
3. The inspection revealed that Respondent manufactured a
chemical substance, (CBI deleted), hereinafter known
as Chemical A.
4. A premanufacture notice was submitted to EPA for review of
Chemical A on (CBI deleted), and was assigned PMN case number
(CBI deleted).
5. The 90—day premanufacturing review process for PMN
(CBI deleted) expired on (CBI deleted), as permitted by
40 CFR Section 720.75(a).

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—3—
6. On (CBI deleted), Respondent submitted a notice of
commencement of manufacture for Chemical A as required
by 40 CFR..Section 720.102.
7. The notice of commencement of manufacture for Chemical A
was received by the Agency and included on the list of
chemical substances maintained by the Administrator
pursuant to 15 U.S.C. 2607 on (CBI deleted).
8. Inspection of Respondent’s records revealed that the first
commercial batch of Chemical A began on (CBI deleted),
(CBI deleted) days after the notice of commencement was
submitted to the EPA.
9. 40 CFR Section 720.102(b) requires submission of a notice
of commencement of manufacture on, or no later than 30
calendar days after the first date of such manufacture.
15 U.S.C. 2614(l)(C) prohibits the violation of any rule
promulgated pursuant to Section 5 of TSCA. Section 15(3)(B)
of TSCA, 15 U.S.C. 2614(3)(B) provides that it is unlawful
for any person to fail or refuse to submit reports, notices,
or other information as required by the Act.

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—4—
10. Respondent violated 40 CFR Section 720.102(b), 15 U.S.c.
2614(1)(C), and 15 U.S.C. 2614(3)(B) by failing to submit
a timely notice of commencement to the Administrator of
EPA on, or no later than 30 calendar days after the date of
such manufacture as required.
PROPOSED CIVIL PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this Complaint,
and upon the nature, circumstances, extent and gravity of the
violations alleged, as well as Respondent’s history of prior
violations of TSCA, the degree of culpability and such other
matters as Justice may require, the Complainant proposes that
Respondent be assessed the following civil penalty for the
violations alleged in this Complaint:
COUNT I
Failure to comply with
notice of commencement
requirements.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 10 ,000
15 U.S.C. 2604(a)(l)
15 U.S.C. 2614(1)(C)
15 U.S.C. 2614(3)(B)

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—5—
NOTICE OF OPPORTUNITY TO
REQUEST A HEARING
As provided in Section 16(a)(2)(A) of TSCA, and in
accordance with 554 of Title 5, United States Code, you have
‘the right to request a formal hearing to contest any material
fact set forth in this Complaint or to contest the appropriate-
ness of the proposed penalty. To avoid being found in default
and having the above-cited penalty assessed without further
proceedings, you must file a written Answer within twenty (20)
days of your receipt of this Complaint. Your Answer should
(1) clearly and directly admit, deny, or explain each of the
factual allegations contained in thisComplaint, (2) brIefly
state all facts and circumstances, if any, which constitute
grounds for a defense, and (3) specifIcally request an
administrative hearing (If desired). The denial of any
material fact or the raising of any affirmative defense shall
be construed as a request for hearing. Failure to deny any
of the factual allegations In this Complaint will constitute
an admission of the undenied allegations. The Answer should
be sent to:
Headquarters Hearing Clerk (A-hO)
United States Environmental
Protection Agency
401 M Street, S.W. , Room 3706
Washington, DC 20460

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-6-
The hearing which will be held upon your request will be
conducted In accordance with the Administrative Procedure Act
(5 U.S.C. SectIon 551 et and the “Consolidated Rules of
Practice Governing the Administrative Assessment of Clvii
Penalties and the Revocation or Suspension of Permits” 40 CFR
Part 22 (45 FR 24360). A copy of the Consolidated Rules
accompanies this Complaint.
INFORMAL SETTLEMENT CONFERENCE
Whether or not you request a hearing, you may confer
Informally with EPA to discuss the facts of this case, or amount
of the proposed penalty, and the possibility of settlement. An
Informal settlement conference does not, however, affect your
obligation to file a written Answer to the Complaint.
EPA has the authority to modify the amount of the proposed
penalty, where appropriate, to reflect any settlement reached
with you in an informal conference. The terms of such an
agreement would be embodied In a Consent Agreement and Final
Order. A Consent Agreement signed by EPA and yourself would
be binding as to all terms and conditions specified therein.

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—7—
Any requests for an informal conference, copies of all.
documents to be filed by Respondent, including the Answer,
and any otherquestions that you may have regarding this
Complaint should be directed to:
Jon D. Silberman, Attorney
Toxics Litigation Division
(L E— 134 )
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
(202) 475—8694
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or requesting
an informal settlement conference, you may choose to pay the pro-
posed penalty. Such payment should be made by sending to the
Headquarters Hearing Clerk’s address listed below a cashier’s
or certified check in the amount of the penalty assessed in this
Complaint. Your check must be made payable to the United
States of America and sent to:
EPA—Washington
(Hearing Clerk)
P.O. Box 360277M
Pittburgh, PA 15251

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-8-
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
Complainant
BY:
Ken Shiroishi, Director
Compliance Division (EPI—342)
Date:

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—9—
CERTIFICATIO’
I hereby certify that the original of the foregoing Complaint
and Notice of Opportunity for Hearing, Docket tb. TSCA-88-H—03,
has been filed with the Headauarters Hearing Clerk and that copies
were sent, registered mail, return receipt requested to:
Mr. Lee Goodrich
West Point — Peoperell, Inc.
P.O. Box 7].
West Point, GA 31833
Date John Mason (EN—342)
Document Control Officer
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460

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UHITED STATES ENVIRONMENTAL PROTECTIOW ENCY
REGION V
:2”
IN RE: )
)
REICNMOLD CHEMICALS, INCORPORATED )
MORRIS, ILLINOIS 60450 ) Docket No. TSCA-V-C—
)
TSCAVC ‘89
COMPLAINT
Ang
- NOTICE OF OPPORTUNITY FOR HEARING
I
COMPLAINT
GENERAL ALLEGATIONS
1. This is a civil administrative action instituted pursuant
to Section 16(a) of the Toxic Substances Control Act, 15 U.S.C.
2601 . (hereinafter “TSCA”), 15 U.S.C. § 2615(a), and
Sections 22.Ol(a)(5) and 22.13 of the Consolidated Rules of
Practice Governing the Administrative Assessment of Civil Penalties
and the Revocation or Suspension of Permits, 40 C.F.R. § §
22.Ol(a)(5), 22.13.
2. The Complainant is, by lawful delegation, the Director,
Environmental Sciences Division, Region V, United States
nvironmenta1 Protection Agency (hereinafter “U.S. EPA”).
4L

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—2—
3. The Respondent is Reichhold Chemicals, Inc., which is
and was at all times relevant to this Complaint, a corporation
incorporated under the laws of the State of Delaware, with a place
of business at Collins Road, Goose Lake Township, Morris, Illinois
60450.
4. The Chemical Information Rules were lawfully promulgated
pursuant to Section 8 of TSCA, 15 U.S.C. § 2607, on June 22,
1982 (47 26992). The Chemical Information Rules have
been subsequently amended and are codified at 40 C.F.R. Part 712.
5. Respondent is a “person” as defined in 40 C.F.R. §
712.3(1).
6. On March 10, 1987, a representative of the U.S. EPA
conducted an inspection of Respondent’s facility located at Morris,
Illinois to determine compliance with the Chemical Information
Rules. -
COUNT I
7. The General Allegations of the Complaint are incorporated
by reference as though set forth here in full.
8. As specified in 40 C.F.R. § 712.30(d) a Preliminary
Assessment information (PAl) Manufacturer’s Report for maleic

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—3—
arthydride was required to be submitted to the U.S. EPA by November
19, 1982. -
9. 40 C.F.R. § 712.20 provides that persons who manufactured
a chemical substance listed in § 712.30 are required to submit a
PAl report for each plant site at which they manufactured the
chemical substance during the reporting period specified in §
712.30.
10. According to 40 C.F.R. § 712.30(a)(2) the Report was to
have covered the Respondent’s latest complete corporate fiscal
year as of the effective date of the Rule.
11. The reporting requirements of § 712.30(d) were effective
on July 22, l982.f The Respondent’s latest complete corporate
fiscal year as of this date was from January 1, 1981 to Decembe J
31, 1981.
12. The Respondent, in writing, notified U.S. EPA on July
26, 1982, that they no longer manufactured maleic anhydride.
13. During the March 10, 1987, inspection, the EPA
representative determined that Respondent had manufactured maleic
anhydride during the reporting period and was required by 40 C.F.R.
Part 712 to submit a timely and complete PAt report for this
substance for the Morris, Illinois facility.

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—4—
14. The Respondent failed to submit a PAl Report for maleic
anhydride, contrary to 40 C.F.R. Part 712, and in violation of
Section 15(3) of TSCA, 15 U.S.C. § 2614(3).
II
PROPOSED CIVIL PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in Part I of
this Complaint, and upon the nature, circumstances, extent and
gravity of the violations alleged, as well as Respondent’s history
of prior violations of TSCA, the degree of culpability, and such
other matters as justice may require, the Complainant proposes
that Respondent be assessed the following civil penalty for the
violations alleged in this Complaint.
COUNT I
Failure to submit a report in the manner required by a TSCA Rule
$13,000
15 U.S.C. § 2614
40 C.F.R. Part 712
TOTALPENALTY . . . . . . . . . . . . .$l3,000
Payment of this penalty may be made by certified or cashier’s
check payable to “Treasurer, the United States of America,” and
remitted to:

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—5—
U.S. Environmental Protection Agency,
Region V
P.O. Box 70753
Chicago, Illinois 60673
A cony of the check shall be sent to:
Branch Secretary
Pesticides & Toxic Substances Branch, (5SPT—7)
U.S. Environmental Protection Agency
230 South Dearborn Street
Chicago, Illinois 60604
A transmittal letter identifying this Complaint shall
accompany the remittance and copy.
The penalties proposed in Part II of this Complaint were
derived by applying the factors enumerated above to the particular
allegations that constitute the violations charged in this action.
The reasoning for each assessment is explained in detail in the
“Guidelines for Assessment of Civil Penalties Under Section 16 of
the Toxic Substances Control Act,” which appears in the
Register of September 10, 1980, at 45 ad. Egg. 59770.
III
OPPORTUNITY TO REOUEST A HEARING
As provided in TSCA Section 16(a) arid in accordance with
the Administrative Procedure Act (5 U.S.C. ç 552 gt gg.), you
have the right to request a hearing regarding the Complaint, to
contest any material fact contained in the Complaint, or to
contest the appropriateness of the amount of the proposed penalty.
If you wish to avoid being found in default, you must file a
written Answer to this Complaint and a Request for Hearing with
the Regional Hearing Clerk (5MFA-14), U.S. Environmental

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Protection Agency, Region V, 230 South Dearborn Street, Chicago,
Illinois 60604, within twenty (20) days of service of this
Complaint. The Answer must clearly and directly admit, deny or
explain each of the factual allegations contained in the Complaint
with respect to which Respondent has any knowledge, or clearly
state that Respondent has no knowledge as to particular factual
allegations in the Complaint. The Answer shall also state:
1. The circumstances or arguments which are alleged to
constitute grounds of defense;
2. The facts which Respondent intends to place at issue.
The denial of any material fact or the raising of any
affirmative defense shall be construed as a request for a hearing.
Failure to deny any of the factual allegations in this Complaint
constitutes admission of the undenied allegations. A co v of
this Answer and any subsequent documents filed in this action
should be sent to Mr. Vincent Giordano, Attorney-Advisor, LE-134P,
U.S. Environmental Protection Agency, 401 M Street, SW, Washington,
D.C. 20460. Mr. Giordano may be telephoned at (202) 475—8693.
Any hearing that you request will be held and conducted in
accordance with the provisions of the Administrative Procedure
Act (5 U.S.C. • 552 g.) and the Consolidated Rules of
Practice Governing Administrative Assessment of Civil Penalties
and the Revocation or Suspension of Permits, 40 C.F.R. Part 22.
A copy of these rules accompanies this Complaint.
If you fail to file a written Answer and Request for Hearing
within twenty (20) days of service of this Complaint, a Default

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Order may thereafter be issued by the Regional Administrator. As
Respondent, your default constitutes a binding admission of all
allegations made- in the Complaint and a waiver of your right to a
hearing under TSCA. The civil penalty proposed herein shall then
become due and payable without further proceedings. Such Default
Order is not subject to review in any court. In addition, the
default penalty is subject to the provisions relating to imposition
of interest, penalty and handling charges set forth in TSCA, 15
U.S.C. § 2615(a)(4), and the Federal Claims Collection Act of
1966, 31 U.S.C. § 3717. Interest will accrue on the default
penalty at the rate established by the Secretary of the Treasury
pursuant to 31 U.S.C. § 3717. A late payment handling charge of
twenty ($20.00) dollars will be imposed after thirty (30) days,
with an additional charge of ten ($10.00) dollars for each
subsequent 30-day period over which an unpaid balance remains.
In addition, a six (6%) percent per annum penalty will be applied
on any principal amount not paid within ninety (90) days of the
date that the Default Order is signed by the Regional
Administrator.

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Iv
SETTLD(ENT CONFERENCE
Whether or not you request a hearing, an informal conference
may be requested in order to discuss the facts of this case and
to arrive at a settlement. To request a settlement conference,•
please write to Ms. Abeer Hashem, Environmental Scientist,
Pesticides & Toxic Substances Branch (5SPT-7), United States
Environmental Protection Agency, Region V, 230 South Dearborn
Street, Chicago, Illinois 60604, or telephone her at (312) 886—
1331.
Please note that a request for an informal settlement
conference does not extend the twenty (20)-day period during which
a written Answer and Request for Hearing must be submitted. The
informal conference procedure, however, may be pursued
simultaneously with the adjudicatory hearing procedure.
U.S. EPA encourages all parties against whom a civil penalty
is proposed to pursue the possibilities of settlement as a result
of an informal conference. However, no penalty reduction will be
made simply because such a conference is held. Any settlement
which may be reached as a result of such conference shall be
embodied in a written Consent Agreement and Final Order issued by
the Regional Administrator, U.S. EPA, Region V. The issuance of
such Consent Agreement shall constitute a waiver of your right to
request a hearing on any matter stipulated to therein.
If you have neither effected a settlement by informal
conference nor requested a hearing within the 20-day time period

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allowed by this Notice, the above penalties will become due and
payable upon the Regional Administrator finding you in default
and issuing an Order for payment of penalties not in excess of
those proposed herein. Refusal to remit such penalty will result
in the referral of this matter to the United States Attorney for
collection.
7f Uh 9.
William H. Sanders III, P.E.
Director, Environmental Sciences Division
U.S. Environmental Protection Agency
Region V
Chicago, Illinois 60604
Dated: ____________

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
) Docket No. TSCA—88-H-06
In the Matter of ) COMPLAINT AND NOTICE OF
) OPPORTUNITY FOR HEARING
3M COMPANY ) UNDER SECTION 16(a) OF
(Minnesota Mininq and Manufacturing) ) THE TOXIC SUBSTANCES
) CONTROL ACT
Respondent,
)
_________________________________________________________________________________________ )
COMPLA IN ?
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Control Act,
15 U.S.C. 2601 et sea . (hereinafter “TSCA”). The Complainant
is Connie A. Musarove, Chief Executive Officer, Office of
Compliance Monitoring, Office of Pesticides and Toxic Substances
United States Environmental Protection Agency (EPA), who has
been duly delegated the authority to institute this action.
The Resoondent is the Minnesota Mining and Manufacturing (3M)
Company, P.O. Box 33331, St 1 Paul, Minnesota 55133.
This Complaint serves as notice that Complainant has
reason. to believe that Respondent manufactured (imported)
and used for commercial purposes chemical substances in
violation of Section 5 of TSCA, 15 U.S.C. Section 2604,
Section 15 of TSCA, 15 U.S.C. Section 2614, and Section 13
of TSCA, 1 .5 U.S.C. Section 2612, as follows:

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COUNT I
1. On (CBI deleted), Respondent provided EPA with records
revealing that Respondent manufactured (imported) the new
chemical substance, (CBI deleted), hereinafter designated
as Chemical A.
2. An examination of Respondent’s submitted information revealed
that beginning on (CBI deleted), and continuing to (CBI deleted),
Respondent imported Chemical A on (CBI deleted) different days.
The total importation during this period was (CBI deleted).
3. During the period between (CBI deleted), and (CBI deleted),
the chemical substance, Chemical A, did not appear on the
list of chemical substances maintained by the Administrator
pursuant to 15 U.S.C. 2637.
4. Information provided to EPA by the Respondent revealed that
the chemical substance mentioned in Paragraph 1 was manu-
factured (imported) for use in the United States.

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5. Pespondent failed to submit a notice to the Administrator of
EPA of its intention to manufacture (import) the new chemical
substance, Chemical A.
6. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that
no person may manufacture (Import) a chemical substance which
does not appear on the TSCA chemical substance inventory with-
out submitting a notice to the Administrator of EPA at least
9 ’) days before manufacturing (importing) such substance.
Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provides that
it is unlawful for any person to fail to comply with any re—
quirer ent prescribed by Section 5. Section 15(3)(B) of TECA,
15 U.S.C. 2614(3)(B), provides that it is unlawful for any
person to fail to submit information required by the Act.
7. The conduct described in paragraphs 2 through S above was in
violation of Section 5(a)(1), 15(1)(B), and 15(3)(B) of TSCA
in that Respondent failed to submit a notice to the Adminis—
trator of EPA at least 90 days before manufacture (Import) of
the chemical substance as required.
a

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COUNT II
8. Paragraph 1 of Count I is incorporated and realleged, as if
fully set forth herein.
9. An examination of Respondent’s submitted information revealed
that beginning on (CBI deleted), and continuing to (CBI deleted),
Respondent imported Chemical A on (CBI deleted) different days and
furnished a written statement to the U.S. Customs Service
certifying that Chemical A was not being offered for entry in
violation of TSCA.
1). Respondent failed to submit a notice to the Administrator of
EPA of its intention to manufacture (import) a new chemical
substance as required by Section 5(a) of TSCA.
11. Respondent failed to submit a certification to the district
director at the port of entry representing the true compliance
status of Chemical A.

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12. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(1), provides that
no person may manufacture (import) a chemical substance which
does not appear on the TSCA chemical substance inventory with-
out submitting a notice to the Administratqr of EPA at least
90 days before manufacturing (importing) such substance.
Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the Secretary
of the Treasury to issue rules for the administration of Section
13(a) which provides for the entry of chemical substances into
the customs territory of the United States. The Customs rule
at 19 CFR Part 12, SS12.118 through 12.127, issued under S13(b)
provides that the importer of a chemical substance shall certify
to the district director at the port of entry that the chemical
substance being offered for entry is not in violation of TSCA
or any applicable rule thereunder. Section 15(3)(B) of TSCA,
15 U.S.C. 2614(3)(B), provides that it is unlawful to fail to
submit information as required by this Act or rule therunder.
13. The conduct described in Paragraghs 9 through 11 above was in
violation of Section 5(a)(1), Section 13(b), and Section 15(3)(B)
of TSCA, in that Respondent failed to submit a certification
to the district director at the port of entry adequately re—
presenting the compliance status of Chemical A, as required.

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—6—
COUVT III
14. On (CBI deleted), Respondent provided EPA with records re-
vealing that Respondent manufactured (imported) the new
chemical substance, (CBI deleted), hereinaher designated as
Chemical B.
15. An examination of Respondent’s submitted information revealed
that beginning on (CBI deleted) and continuing to (CBI deleted)
Respondent imported Chemical B on (CBI deleted) different days.
The total importation during this period was (CBI deleted).
16. During the period between (CE! deleted) and (CBI deleted),
the chemical substance, Chemical B, did not appear on the
list of chemical substances maintained by the Administrator
pursuant to 15 U.S.C. 2607.
17. Information provided to EPA by the Respondent revealed that the
chemical substance mentioned in Paragraph 14 was manufactured
(imported) for use in the United States.

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1 . Pespondent failed to submit a notice to the Administrator of
EPA of its lntention to manufacture (import) the new chemical
substance, Chemical B.
19. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that
no person may manufacture (import) a chemical substance which
does not appear on the TSCA chemical substance inventory with-
out submitting a notice to the Administrator of EPA at least
90 days before manufacturing (importing) such substance.
Section 15(l)(B) of TSCA, 15 U.S.C. 2614(1)(B), provide. that
it is unlawful for any person to fail to comply with any re-
quirement prescribed by Section 5. Section 15(3)(B) of TSCA,
15 u.S.C. 2614(3)(B), provides that it is unlawful for any
person to fail to submit information required by the Act.
20. The conduct described In paragraphs 15 through 18 above was
in violation of Section S(a)(l), 15(1)(B.), and 15(3)(B) of
TSCA in that Respondent failed to submit a notice to the
Administrator of EPA at least 90 days before manufacture
(import) of the chemical substance as required.

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COUNT I V
21. Paragraph 14 of Count III is Incorporated and realleged, as if
fully set forth herein.
22. An examination of Respondent’s submitted information revealed
that beginning on (CBI deleted) and continuing to (CBI deleted)
Respondent imported Chemical B on (CBI deleted) different days
and furnished a.written statement to the U.S. Customs Service
certifying that Chemical B was not being offered for entry in
violation of TSCA.
23. Pespondent failed to subrnit a notice to the Administrator of
EPA of its intention to manufacture (Import) a new chemical
substance as required by Section 5(a of TSCA.
24. Respondent failed to submit a certification to the district
director at the port of entry representing the true compliance
status of Chemical B.

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25. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a)(l), provides that
no person may manufacture (import) a chemical substance which
does not appear on the TSCA chemical substance inventory with-
out submitting a notice to the Administrator of EPA at least
90 days before manufacturing (importing) such substance.
Section 13(b) of TSCA, 15 U.S.C. 2612(b) requires the Secretary
of the Treasury to issue rules for the administration of Section
13(a) which provides for the entry of chemical substances into
the customs territory of the United States. The Customs rule
at 19 CFR Part 12, SS12.l18 through 12.127, issued under S13(b)
provides that the importer of a chemical substance shall certify
to the district director at the port of entry that the chemical
substance being offered for entry is not in violation of TSCA
or any applicable rule thereunder. Section 15(3)(B) of TSCA,
15 U.S.C. 2614(3)(B), provides that It is unlawful to fail to
submit information as required by this Act or rule therunder.
26. The conduct described in Paragraghs 22 through 24 above was in
violation of Section 5(a)(l), Section 13(b), and Section 15(3)(B)
of TSCA, in that Respondent failed to submit a certification
to the district director at the port of entry adequately re-
presenting the compliance status of Chemical B, as required.

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— 10 —
PPOPOEED CIVIL PEMALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this Complaint,
and upon the nature, circumstances, extent and gravity of the
violations alleged, as well as Respondent’s history of prior
violations of TSCA, the degree of culpability and such other
matters as justice may require, the Complainant proposes that
Respondent be assessed the following civil penalty for the
violations alleged in this Complaint:
COUNT I
Failure to notify of intention to
manufacture (import) a chemical
substancenoton theTSCAinventory......................$l,609,000
15 U.S.C. 2634(a)(1)
15 U.S.C. 2614(l)(B)
15 U.S.C. 26l4(3)(B)
COUNT II
Failure to provide a certification statement
to the district director at the port of entry
adequately representing the compliance status
of a chemical substance..................................$ 720,000
15 U.S.C. 2604(a)(1)
15 U.S.C. 2612(b)
15 U.S.C. 2614(3)(B)

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— 11 —
COUNT III
Failure to notify of intention to
manufacture (import) a chemical
substance not on the TSCA inventory...................$ 260,000
15 U.S.C. 2604(a)(l)
15 U.S.C. 2614(l)(B)
15 U.S.C. 2614(3)(B)
COUNT IV
Failure to provide a certification statement
to the district director at the port of entry
adequately representing the compliance status
ofa chemicalsubstance.................,.............$ 200,000
15 U.S.C. 2634(a)(1)
15 U.S.C. 2612(b)
15 U.S.C. 2614(3)(B)
TOTAL................................. $ 2,789,0’30
Adjustments to Proposed Penalty
Because Respondent voluntarily disclosed to EPA the
violations alleged in this Complaint, Complainant is adjusting
the proposed penalty downward twenty—five percent. Complainant
is adjusting the proposed penalty an additional twenty—five
percent because Respondent contacted EPA immediately upon
discovering activities in violation of TSCA.
ADJUSTED TOTAL PROPOSED CIVIL PENALTY ............... $ 1,394,500

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— 12 —
NOTICE OF OPPORTUNITY TO
REOUEST A HEARING
As provided in Section 16(a)(2)(A) of TSCA, and in
accordance with 554 of Title 5, United States Code, you have
the right to request a formal hearing to contest any material
fact set forth in this Complaint or to contest the appropriate-
ness of the proposed penalty. To avoid being found in default
and having the above—cited penalty assessed without further
proceedings, you must file a written Answer within twenty (20)
days of your receipt of this Complaint. Your Answer should
(1) clearly and directly admit, deny, or explain each of the
factual allegations contained in this Complaint, (2) briefly
state all facts and circumstances, if any, which constitute
grounds for a defense, and (3) specifically request an
ajministrative hearing (if desired). The denial of any
material fact or the raising of any affirmative defense shall
be construed as a request for hearing. Failure to deny any
of the factual allegations in this Complaint will constitute
an admission of the undenied allegations. The Answer should
be sent to:
Headquarters Hearing Clerk (A—hO)
United States Environmental
Protection Agency
401 P1 Street, S.W., Room 3706
Washington, DC 20463

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— 13 —
The hearing which will be held upon your request will be
conducted in accordance with the Administrative Procedure Act
(5 U.S.C. Section 551 et seq.) and the Consolldated Rules of
Practice Governing the Administrative Assessment of Civil
Penalties and the Revocation or Suspension of Permitsu 40 CFR
Part 22 (45 FR 24360). A copy of the Consolidated Rules
accompanies this Complaint.
INFO 4AL SETTLEMENT CONFERENCE
Whether or not you request a hearing, you may confer
informally with EPA to discuss the facts of this case, or amount
of the proposed penalty, and the possibility of settlement. An
informal settlement conference does not, however, affect your
obligation to file a written Answer to the Complaint.
EPA has the authority to modify the amount of the proposed
penalty, where appropriate, to reflect any settlement reached
with you in an informal conference. The terms of such an
agreement would be embodied in a Consent Agreement and Final
Order. A Consent Agreement signed by EPA and yourself would
be binding as to all terms and conditions specified therein.

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— 14 —
Any requests for an informal conference, copies of all
documents to be filed by Respondent, including the Answer,
and any other questions that you may have regarding this
Complaint should be directed to:
Mr. Bob Pittman, Attorney
Toxics Litigation Division
(LE—134—P)
U.S. Environmental Protection Agency
431 M Street, S.W.
Washington, D.C. 20460
(202) 475—8690
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or requesting
an informal settlement conference, you may choose to pay the pro-
posed penalty. Such payment should be made by sending to the
Headquarters Hearing Clerk’s address listed below a cashier’s
or certified check in the amount of the penalty assessed in this
Complaint. Your check must be made payable to the United
States of America and sent to:
EPA—Washington
(Hearing Clerk)
P.O. Box 360277M
Pittburgh, PA 15251

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— 15 —
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
Complainant
BY: \
Connie A. Musgrove
Chief Executive Officer
Office of Compliance Monitoring
SEP 2I98
Date:

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— 16 —
CERTIFICATION
I hereby certify that the original of the foregoing complaint
and Notice of Opportunity for Hearing, Docket No TSCA-88-H-06,
has been filed with the Headauarters Hearing Clerk and that copies
were sent, registered mail, return receipt requested to:
Mr. Uan Jacobson, Chairman
Minnesota Mining and Manufacturing
(3M Comoany)
P .O. Box 33331
St. Paul, MN 55133
__ _______ ‘t Za
)ate John Mason (EN—342)
Document Control Officer
U.S. Ei vironmental Protection Agency
401 M Street, S.W.
Washinaton, D.C. 20460

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
______________________________ Docket No. TSCA 89—H—21
) COMPLAINT AND NOTICE OF
In the Matter of ) OPPORTUNITY FOR HEARING
Monsanto Company ) UNDER SECTION 16(a) OF
) THE TOXIC SUBS CES
Respondent ) CONTROL ACT
_________________ )
c
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Contro ”Act,
15 U.S.C. 2601 et (hereinafter “TSCA”). The Complainant is
Michael F. Wood, Director, Compliance Division, Office of
Compliance Monitoring, United States Environmental Proteàtion
Agency (EPA), who has been duly delegated the authority to
institute this action. The Respondent is Monsanto Company, St.
Louis, Missouri, a manufacturer, processor and distributor of
chemical substances and mixtures in commerce.
This Complaint serves as notice that Complainant has reason
to believe that Respondent failed to immediately submit
information as required by Section 8 of TSCA, 15, U.s. c. Section
2607, and Section 15 of TSCA, 15 U.S.C. Section 2614, as follows:

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—2—
1. The Respondent is a manufacturer, processor and distributor
of the chemical substance, Santogard PVI (Chemical Abstract
Services Registry No. 17796—82—6; also known as test
substance CP 29242), a pre—vulcanization inhibitor used in
the production of natural and synthetic rubber products.
2. On or about Septernoer 28, 1978, a “CP29242: Two—year Chronic
Toxicity and Carcinogenicity Study in the Rat” (hereinafter
referred t as the “study”) was initiated for the Respondent
at Pharmecopathics Research Laboratories, Inc. (currently
Tegeris Laboratories. Inc.), Laurel, Maryland. The in—life
portion of this study terminated on or aoout October 21,
19a0.
3. On or aoout October 15. 1981, Respondent obtained a copy of
the reported results from tne study. Page 68 of the October
15, 1981 rej ort states that Santogard PVI “...when fed to
the rats under the conditions of this experiment, causes a
dose—related effect in body weight and hepatic
histopathology.” The report also states that
“histopathologically the only tumor findings that appear
pertinent (compound related) . . . are limited to the liver
In the dead and moribund animals there were .
3/33 adenomata ((i.e., adenomas)Jiri the female mid—dose
group. 5/34 adenomata in the female high—dose group and 1/33
hepatocellular carcinoma in the female mid-dose group; in

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—3—
the surviving animals there were . . . 1/37 adenomata in the
female mid—dose group and 6/41 adenomata in the female high—
dose group.”
4. In regard to item 3. above,, combining the incidence of
hepatocellular adenomas in the females found dead and
sacrificed moribund with those in the surviving group
animals, the number of females with hepatocellular adenomas
n the mid-dose group is 4 of 70 or 5.7% whereas in the
high—dose group it is 11 of 75 or 14.7%.
5. The October 15, 1981 report results indicate a dose—related
incidence in the number of female rats with benign liver
twnors (hepatoceliular adenornas).
6. On or about March 6. 1984, Respondent obtained a copy of a
report at d March 1. l9 4, concerning tne sar e study. Page
72 of this report states “Combining the incidence of
adenomas in the females designed as ‘dead and sacrificed
rnori und’ with tnose in the ‘surviving group’ animals, the
number of animals with adenomas in the mid—dose group was
now 4 of 70 or 5.7% whereas in the high—dose group it was 11
of 75 or 14.7%. These results suggest an association
between test chemical [ (C?29242)J and the observation of
benign hepatic adenomas in treated females.”
7. The March 1, 1984 report results indicate a dose— related
incidence in the number of female rats with benign liver
tumors (hepatocellular adenomas).

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—4—
8. SectiOn 8(e) of TSCA, 15 U.S.C. Section 2607(e), provides
that “Any person who manufactures, processes, or distrioutes
in commerce a chemical substance or m xture and who obtains
information which reasonably supports the conclusion that
such substance or mixture presents a substantial risk of
injury to health or the environment shall immediately inform
the Administrator of such information unless such person has
actual knowledge that the Administrator has been adequately
informed of such information.”
9. In a July 1, 1986 letter addressed to Mr. Edwin F.
Tinsworth, Acting Director of the Office of Toxic
Substances, Respondent informed tne EPA on a “for your
informatior.” basis of tne results of the study.
Respondent’s letter included a copy of the Abstract section
and several tables from the March 1, 1984 report.
10. EPA received the Respondent’s July 1, 1986 “for your
information” letter and enclosures on or about July 3, 1986.
11. The EPA “Statement of Interpretation and Enforcec ent Policy;
Notification of Substantial Risk” under TSCA Section 8(e)
published in the Federal Register (43 FR 11110, March 16,
1978), hereinafter referred to as “the Section 8(e) policy
statement” sets forth EPA’S interpretation of and policy
concerning the provisions of TSCA Section 8(e).
12. Respondent is a “person” as defined in Part I of the Section
8(e) policy statement (43 FR 11111), and has been a
ma iufacturer of Santogard PVI since 1976.

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—5—
13. The Section 8(e) policy statement provides that a person has
“immediately informed” EPA if the information is received
bj EPA within 15 working days of the person’s receipt of
such information.
14. Tne Section 8(e) policy statement provides that information
must be reported in accordance with Part IX (“Reporting
Rep.iirernents”) of the policy statement.
15. The findings concerning the dose-related incidence of benign
liver tumors obtained by the Respondent in the October 15,
1981 report arid/or the March 1, 1984 report reasonably
support the conclusion that the chemical substance,
Santogard PVI, presents a substantial risk of injury to
health or the environr 1ent, and are not corroborative of well
established adverse effects already documented in the
scientific literature or about which the Administrator was
adequately informed.
16. Respondent failed to immediately inform the Administrator
about the dose-related incidence of benign liver tumors
at’iong the female rats in the Respondent’s “CP29242: Two—year
Chronic Toxicity and Carcinogenicity Study in the Rat.”
17. Section 15(3)(8) of TSCA provides that it is unlawful for
anyone to fail to submit information required by TSCA.

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—6—
PROPOSED CIVIL. PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, autnorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this
Complaint, and upon the nature, circumstance, extent and gravity
of the violations alleged, as well as Respondent’s history of
prior violations of TSCA, the degree of culpability and sucn
other matters as justice may require, the Complainant proposes
that Respondent be assessed a civil penalty of $253,200 for the
violation alleged in this Complaint.
NOTICE OF OPPORTUNITY TO
RE.QUEST A hE..R RING
As provided in Section 16(a) (2) (A) of TSCA, and in
accordance with 554 of Title 5, United States Code, you have the
right to request a formal hearing to contest any material fact
set forth in this Complaint or to contest the appropriateness of
the proposed penalty. To avoid being found in default and having
tne above-cited penalty assessed without further proceedings, you
must file a written Answer within twenty (20) days of your
receipt of this Complaint. Your Answer should (1) clearly and
directly admit, deny, or expiain each of the factual allegations
contained in this Complaint, (2) briefly state all facts and

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—7—
circumstances, if any, which constitute grounds for a defense,
and (3) specifically request an administrative hearing (if
d?sired). The denial of any material fact or the raising of any
affirmat’ve defense shall be construed as a request for a
hearing. Failure to deny any of the factual allegations in this
Cor piaint will constitute an admission of the undenied
allegations. The Answer should be sent to:
Headquarters Hearing Clerk (A—hO)
United States Environmental
Protection Agency
401 M Street, S.W., Room 3706
Washington, DC 2O46
Tne hearing which will be held upon your request will be
conductei in accordance with the Administrative Procedure Act
(5 U.S.C. Se:tiou 551 et seq. ) and the “Consolidated Rules of
Pract. ce Governing the Administrative Assessment of Civil
Penalties and the Revocation or Suspensior of Permits” 40 CFR
Pa:t 22 (45 FR 24.6 ). A copy of the Consolidated Rules
accor panies this Complaint.
INFORMAL. SETTLEMENT CONFERENCE
Wnether or not you request a hearing, you may confer
informa. ly with EPA to discuss the facts of this case, or am3unt
of the proposed penalty, and the possibility of settlement. An
informal settlement conference does not, however, affect your
obligation to file a written Answer to the Complaint.

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—8—
EPA has the authority to modify the amount of the proposed
penalty, where appropriate, to reflect any settlement reached
with you in au informal conference. The terms of such an
agreement would be embodied in a Consent Agreement and Final
Order. A Cocusent Agreement signed by EPA and yourself would be
oiriding as to all terms and conditions specified therein.
Any requests for an informal conference, copies of all
docu.1 ent.3 to be filed by Respondent, including the Answer, and
any other questions that you may have regarding this Complaint
si ould oe directed to:
Mr. Vincent Giordano, Attorney
Toxics itigation Division
(LE—134—P;
U.S. Environmental Protection Agency
401 M Street, S. .
Washington, DC 20460
(202) —475—8693
PAYMENT OF PENAEdTY
Instead of filing an Answer requesting a hearing or
requesting an informal settlement conference, you may choose to
pay the proposed penalty. Such payment should be made by
sending to the Headquarters Hearing Clerk’s address listed below
a cashier’s or certified check in the amount of the penalty
assessed in this Complaint. Your check mast be made payable to
the United States of America and sent to:
EPA—Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251

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—9—
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
TSCA 89—H—21.
Complainant
BY:
Michael f. Wooa, Directo
Compliance Division
Office of Cor pliance Monitoring
Date:

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— 10 —
CERTIFICATION
I hereby certify that the original of the foregoing Complaint and
Notice of Opportunity for Hearing, Docket No. TSCA—89—H—21 , has
been filed with the Headquarters Hearing Clerk and that copies
were sent, registered mail, return receipt requested to:
Mr. James H. Senger
Vice President
Monsanto Company
800 N. Lindbergh Boulevard
St. Louis, Missouri 63167
j ’D e AcA-p7
D te / ose Burgess (EN-342)
Case Preparation Officer
U.S. Environmental Protection Agency
4C1 M Street, S.W.
Washington, D.C. 20460

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‘ •
C ,..
UNITED kTES
FM1I OUMENTAL PROTECTION AGENCY
)
In the Matter of )
)
3M comoany ) Docket No. TSCA 88-H—06
(Minnesota Mining and Manufacturina) )
)
Pespondent, ).
____________________________________________________________________________________________ )
Notice of Treatment of Confidential Business Information
Portions o the attached Comolaint reouire use of information
which Resoondent submitted to the United States Environmental -
Protection aency (EPa) as Confidential Business Information (CBI).
Information in the Complaint constituting or based on C3I has
been deleted as Indicated by the follouin’,: (CBI deleted). The
original complaint containing CBI is filed with the Headquarters
Hearina Clerk. It will itself be treated as confidential unless
Pesoondent waives confidentiality thereto or EPA releases the
information in accordance with 40 C.F.R. part 2.
S

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of
ALCOLAC INCORPORATED ) Docket No. TSCA 89—H— 22
Respondent
__________________________________________________________________________________ )
Notice of Treatement of Confidential Business Information
Portions of the attached Complaint require use of
information which Respondent submitted to the United States
Environmental Protection Agency (EPA) as Confidential Business
Information (CEl). Information in the Complaint constituting or
based on CBI has been deleted as indicated by the following:
(CEl deleted). The original Complaint containing CBI is filed
with tne headquarters Hearing Clerk. It will itself be treated
as confidential unless and until Respondent waives
confidentiality thereto or EPA releases the information in
accordance with 40 CER Part 2.

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—2—
1. On August 1, 1984, May 20—21, 1986, and June 12, 1987,
inspections were conducted, by duly designated
representatives of the EPA, at Respondent’s facilities
located at 3440 Fairfield Road, Baltimore, Maryland and at
Randall Road, Sedalia, Missouri, respectively.
2. These inspections were conducted to determine Respondent’s
compliance with TSCA requirements.
COUNT I
3. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
4. Respondent is a “person” as defined in 40 CFR Section
720.3(x) and as such is subject to TSCA and the regulations
promulgated thereunder.
5. Respondent’s records revealed that Respondent manufactured
for commercial purposes the chemical substances as described
in Counts I—IV, respectively.
6. On these occasions, the chemicals identified in Counts i-i ll
of this Complaint, did not appear on the TSCA Inventory of
Existing Chemical Substances (“TSCA Inventory”) maintained
by the Administrator pursuant to 15 U.S.C. Section 2607.

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—4—
COUNT II
12. Paragraphs 3 — 6 are hereby incorporated and realleged as if
fully set forth herein.
13. Records revealed that Respondent manufactured a new chemical
substance, (CBI deleted), CAS # (CBI deleted), and
identified by product code name (CBI deleted), hereinafter
designated as Chemical B.
14. Paragraphs 8 — 9 are hereby incorporated and realleged as if
fully set forth herein.
15. Respondent’s records revealed that from March 1982 through
December 1986, Respondent had manufactured (CBI deleted)
pounds of Chemical B for TSCA commercial purposes. During
this time period, Respondent manufactured Chemical B on at
least (CBI deleted) separate occasions.
16. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical B, at least
ninety (90) days before manufacturing Chemical B, thereby
violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B).
COUNT III
17. Paragrapfls 3 — 6 are hereby incorporated and realleged as if
fully set forth herein.

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—6—
CAS * Chemical Production Amt
(CBI deleted) Chemical D (CBI deleted)
(CBI deleted) Chemical E (CBI deleted)
24. According to 40 CFR Section 712.20(a), a person who
manufacture in bulk form one or more of the chemical
substances listed in 40 CFR Section 712.30 for commercial
purposes must submit a Preliminary Assessment Information
Report, (hereinafter referred to as a PAIR), to the
Administrator of EPA, as required under Section 8(a) of
TSCA.
25. Respondent is a “person” as defined in 40 CFR Section
712.3(6).
26. Section 8(a)(1) of TSCA authorized the Administrator of EPA
to issue rules that requires reporting by manufacturers,
importers and processors of chemical substances. The PAIR
rules were promulgated on June 2, 1982 under 40 CFR Part
712, Subpart B entitled, Manufacturers Reporting——
Preliminary Assessment Information. Section 15(3) (B) of
TSCA, 15 U.S.C. 2614(3) (B) provides that it is unlawful for
any person to fail or refuse to submit reports as required
under TSCA.
27. According to 40 CFR Section 712.30(a), Respondent was
required to submit a PAIR for Chemicals D and E covering
their 1981 calendar year production on or before
November 19, 1982.

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—8—
35. Pursuant to Section 8(a) of the Act, 15 U.S.C. Section
2607(a), EPA promulgated the “Inventory Reporting
Regulations”, codified at 40 CFR Part 710. 40 CFR Part 710
establishes regulations governing reporting certain sub-
stances for commercial purposes under Section 8(a) of the
Act.
36. Pursuant to 40 CFR Sections 710.3 and 710.4, all persons wno
manufactured and/or imported a chemical substance for a
commercial purpose during 1977 were required to submit
specific information to EPA concerning that chemical
substance for inclusion in EPA’s initial TSCA inventory of
chemical substances manufactured for commercial purposes
under the Act, and only persons who manufactured or imported
a chemical subtance for commercial purposes from January 1,
1975 to July 1, 1979 were permitted to report to EPA
concerning that chemical substance for EPA’S TSCA Inventory
of Chemical Substances.
37. Supplemental information submitted by the Respondent
subsequent to the inspections, revealed that chemical
substances F, G, and H cited in paragraphs 33 and 34 of this
Complaint had not been manufactured by Respondent for
commercial purposes at any time since January 1, 1975.
Respondent therefore was not permitted to report these
chemical substances for EPA’S TSCA Inventory of Chemical
Substances.

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—10—
COUNTS I — III
Failure to notify of intention to
manufacture a new chemical substance:
15 U.S.C. 2604 (a)(1)
15 U.S.C. 2614 (1)(B)
15 u.s.c. 2614 (3) (B)
$ 273.000
$ 16,500
$ 145.000
COUNT . $ 434,50a
COUNT IV
Failure to submit PAIR reports
as rec uired:
15 U.S.C. 2607 (a)(1)
15 U.S.C. 2614 (3) (B)
COUNT . .. . $ 68 378
COUNT V
False reporting of chemical substances
as manufactured for commercial purposes.
Respondent is sole submitter of each
chemical to EPA TSCA Inventory: -
15 U.S.C. 2607 (a)(] .)
15 U.S.C. 2614 (3)(B)
COUNT .......•.................... $ 51.000
TOTAL PROPOSED CIVIL PENALTY .......... .. .... $ 553,878

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—12—
Ti’e Answer shall also state the circumstances and arguments,
if any, which are alleged to constitute the grounds of defense,
and shall specifically request an administrative hearing, if
desired. If you deny any material fact or raise any affirmative
defense, you will be considered to have requested a hearing.
The Answer must be filed with:
Headquarters Hearing Clerk (A—hO)
United States Environmental Protection Agency
401 M Street, S.W., Room M3706
Washington, DC 20460
Please send a copy of the Answer an all other documents which you
file in this action to Vincent Giordano, the attorney assigned to
represent EPA in this matter, at:
Toxics Litigation Division (LE—134P)
Office of Enfoccenent and Compliance Monitoring
U.S. Environmental Protection Agency
401 M Street, S.W., Rm. NE hl3A
asnington, D.C. 20460
INFORMAL SETTLEMENT CONFERENCE
Whether or not you request a hearing, you may confer
informally with EPA through Mr. Giordano regarding the facts of
this case, or amount of the proposed penalty, and the possibility
of settlement. An informal settlement conference does not,
nowever, affect your obligation to file a written Answer to the
Complaint.

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—14—
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
TSCA 8 9—H- 22
Complainant
BY:
c. s2
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring
Date:

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UNITED STATES
ENVIRONMENTAEa PROTECTION AGENCY
In the Matter of
ALCOLAC INCORPORATED ) Docket No. TSCA 89—H- 22
Respondent )
Notice of Treatement of Confidential Business Information
Portions of the attached Complaint require use of
information which Respondent submitted to the United States
Environmental Protection Agency (EPA) as Confidential Business
Information (CBI). Information in the Complaint constituting or
based on CBI has been deleted as indicated by the following:
(CBI deleted). The original Complaint containing CBI is filed
with the headquarters Hearing Clerk. It will itself be treated
as confidential unless and until Respondent waives
confidentiality thereto or EPA releases the information in
accordance with 40 CFR Part 2.

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UNITED STATES
ENVIRONMENTAL. PROTECTION AGENCY
______________________________ Docket No. TSCA 89—H—22
COMPLAINT AND NOTICE OF
In the Matter of ) OPPORTUNITY FOR HEARING
ALCOLAC INCORPORATED ) UNDER SECTION 16(a) OF
THE TOXIC SUBSTANCES
Respondent ) CONTROL ACT
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Control Act,
15 U.S.C. 2601 et se • (hereinafter “TSCA”). The Complainant is
Michael F. Wood, Director, Compliance Division, Office of
Compliance Monitoring, United States Environmental Protection
Agency (EPA), who has been duly delegated the authority to
institute this action. The Respondent is Alcolac Incorporated,
Baltimore, Maryland.
This Complaint serves as notice that Complainant has reason
to believe that Respondent manufactured chemical substances in
violation of Sections 5, 8 and 15 of TSCA, 15, U.S.C. Section
2614, as follows:

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—2—
1. On August 1, 1984, May 20—21, 1986, and June 12, 1987,
inspections were conducted, by duly designated
representatives of the EPA, at Respondent’s facilities
located at 3440 Fairfield Road, Baltimore, Maryland and at
Randall Road, Sedalia, Missouri, respectively.
2. These inspections were conducted to determine Respondent’s
compliance with TSCA requirements.
COUNT I
3. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
4. Respondent is a “person” as defined in 40 CFR Section
720.3(x) and as such is subject to TSCA and the regulations
promulgated thereunder.
5. Respondent’s records revealed that Respondent manufactured
for commercial purposes the chemical. substances as described
in Counts I—IV, respectively.
6. On these occasions, the chemicals identified in Counts I—Ill
of this Complaint, did not appear on the TSCA Inventory of
Existing Chemical Substances (“TSCA Inventory”) maintained
by the Administrator pursuant to 15 U.S.C. Section 2607.

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—3—
7. Records revealed that Respondent manufactured a new chemical
substance, (CBI deleted), chemical abstract number (CBI
deleted), and identified by product code name (CBI deleted),
hereinafter designated as Chemical A.
8. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a) (1), provides that
no person may manufacture a chemical substance which does
not appear on the TSCA chemical substance inventory without
first submitting a Premanufacture Notification to the
Administrator of EPA at least 90 days before manufacturing
such substance.
9. Section 15(1) (B) of TSCA, 15 U.S.C. 2614(1) (B) , provides
that it is unlawful for any person to fail or refuse to
comply with any requirement prescribed by Section 5.
Section 15(3)(B) of TSCA, 15 U.S.C. 2614(3) (B) provides that
it is unlawful for any person to fail or refuse to submit
reports, notices, or other information as required by TSCA.
10. Respondent’s records revealed that between October 1979 and
June 1986, Respondent manufactured (CBI deleted) pounds of
Chemical A for TSCA commercial purposes. During this time
period, Respondent manufactured Chemical A on at least (CBI
deleted) separate occasions.
11. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical A, at least
ninety (90) days before manufacturing Chemical A, thereby
violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B).

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—4—
COUNT II
12. Paragraphs 3 — 6 are hereby incorporated and realleged as if
fully set forth herein.
13. Records revealed that Respondent manufactured a new chemical
substance, (CM deleted), CAS • (CBI deleted), and
identified by product code name (CBI deleted), hereinafter
designated as Chemical B.
14. Paragraphs 8 — 9 are hereby incorporated and realleged as if
fully set forth herein.
15. Respondent’s records revealed that from March 1982 through
December 1986, Respondent had manufactured (CBI deleted)
pounds of Chemical B for TSCA commercial purposes. During
this time period, Respondent manufactured Chemical B on at
least (CBI deleted) separate occasions.
16. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical B, at least
ninety (90) days before manufacturing Chemical B, thereby
violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B).
COUNT III
17. Paragraphs 3 — 6 are hereby incorporated and realleged as if
fully set forth herein.

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—5—
18. Records revealed that Respondent manufactured a new chemical
substance, (CBI deleted), CAS * (CBI deleted) and identified
by product code name (C8I deleted), hereinafter designated
as Chemical C.
19. Paragraphs 8 — 9 are hereby incorporated and real].eged as if
fully set forth herein.
20. Respondent’s records revealed that from October 1983 through
December 1985 Respondent had manufactured (CBI deleted)
pounds of Chemical C for TSCA commercial purposes. During
this time period, Respondent had manufactured Chemical C on
(CBI deleted) separate occasions.
21. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical C, at least
ninety (90) days before manufacturing Chemical C, thereby
violating TSCA Sections 5(a)(1)(A), 15(l)(B), and 15(3)(B).
COUNT IV
22. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
23. Information collected during the inspections and subsequent
information submitted by the Respondent revealed that
Respondent manufactured for TSCA commercial purposes, as
defined at 40 CER Part 712.3, the following chemical
• substances listed as chemical abstract service registry
numbers, (CAS *s) from January 1981 through December 1981:

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—6—
CAS * Chemical Production Amt
(CBI deleted) Chemical D (CBI deleted)
(CHI deleted) Chemical E (CBI deleted)
24. According to 40 CFR Section 712.20(a), a person who
manufacture in bulk form one or more of the chemical
substances listed in 40 CFR Section 712.30 for commercial
purposes must submit a Preliminary Assessment Information
Report, (hereinafter referred to as a PAIR), to the
Administrator of EPA, as required under Section 8(a) of
TSCA.
25. Respondent is a “person” as defined in 40 CFR Section
712.3(6).
26. Section 8(a)(1) of TSCA authorized the Administrator of EPA
to issue rules that requires reporting by manufacturers,
importers and processors of chemical substances. The PAIR
rules were promulgated on June 2, 1982 under 40 CFR Part
712, Subpart B entitled, Manufacturers Reporting—-
Preliminary Assessment Information. Section 15(3) (B) of
TSCA, 15 U.S.C. 2614(3) (B) provides that it is unlawful for
any person to fail or refuse to submit reports as required
under TSCA.
27. According to 40 CFR Section 712.30(a), Respondent was
required to submit a PAIR for Chemicals D and E covering
their 1981 calendar year production on or before
November 19, 1982.

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—7—
28. As of the date of EPA’s August 1, 1984 inspection,
Respondent had not submitted a PAIR for Chemicals D and E on
or before the November 19, 1982 reporting date as required.
29. On or about August 1, 1984, Respondent submitted PAIRS for
Chemicals D and E to the Agency pursuant to 40 CFR Section
712.30(a).
30. On or about November 7, 1986, two years after the August
1984 submissions, Respondent supplied the Agency with a
revised PAIR for Chemical D.
31. As described in Paragraphs 28 and 30 above, Respondent
violated Section 8(a) and 15(3)(B) of TSCA in that
Respondent failed to submit a PAIR for Chemicals D andE to
the Administrator of EPA for the reporting date as required.
COUNT V
32. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
33. On or about June 18, 1978, the Respondent reported to EPA
that the Respondent had manufactured chemical substances
listed as CAS #s (CM deleted and CM deleted), hereinafter
designated as Chemicals F and G, substances for TSCA
commercial purposes since January 1, 1975.
34. On or about May 29, 1979, the Respondent reported to EPA
that the Respondent had manufactured the chemical substance
listed as CAS (CBI deleted), hereinafter designated as
Chemical H, a substance for TSCA commercial purposes since
January 1, 1975.

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—8—
35. Pursuant to Section 8(a) of the Act, 15 U.S.C. Section
2607(a), EPA promulgated the “Inventory Reporting
Regulations”, codified at 40 CFR Part 710. 40 CFR Part 710
establishes regulations governing reporting certain sub-
stances for commercial purposes under Section 8(a) of the
Act.
36. Pursuant to 40 CFR Sections 710.3 and 710.4, all persons wno
manufactured and/or imported a chemical substance for a
commercial purpose during 1977 were required to submit
specific information to EPA concerning that chemical
substance for inclusion in EPA’S initial TSCA inventory of
chemical substances manufactured for commercial purposes
under the Act, and only persons who manufactured or imported
a chemical subtance for commercial purposes from January 1,
1975 to July 1, 1979 were permitted to report to EPA
concerning that chemical substance for EPA’S TSCA Inventory
of Chemical Substances.
37. Supplemental information submitted by the Respondent
subsequent to the inspections, revealed that chemical
substances F, C, and H cited in paragraphs 33 and 34 of this
Complaint had not been manufactured by Respondent for
commercial purposes at any time since January 1, 1975.
Respondent therefore was not permitted to report these
chemical substances for EPA’S TSCA Inventory of Chemical
Substances.

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—9—
38. Respondent was the sole submitter of each of the chemical
substances F, G, and H cited in paragraph 33 and 34 of this
Complaint for EPA’s TSCA Inventory of Chemical Substances.
39. Pursuant to Section 15(3) of the Act, 15 U.S.C. Section
2614(3), it is lawful for any person to fail or refuse to
establish and maintain records or to submit the reports,
notices or other information as required by the Act or a
rule thereunder.
40. As described in Paragraphs 33, 34, and 37 above, Respondent
violated Sections 8(a) and 15(3)(B) of the Act, 15 U.S.C.
Sections 2607(a) and 2614(3) (B) by reporting chemical
substances F, G, and H as chemicals manufactured by
Respondent for commercial purposes.
PROPOSED CIVIL PENALTY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this
Complaint, and upon the nature, circumstances, extent and gravity
of the violations alleged, as well as Respondent’s history of
prior violations of TSCA, the degree of culpability and such
other matters as justice may require, the Complainant proposes
that Respondent be assessed the following civil penalty for the
violations alleged in this Complaint:

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—10—
COUNTS I — III
Failure to notify of intention to
manufacture a new chemical substance:
15 U.S.C. 2604 (a) (1)
15 U.S.C. 2614 (1) (B)
15 u.s.c. 2614 (3) (8)
. . $ 273.000
$ 16,500
$ 145. 000
COUNT $ 434,500
COUNT IV
Failure to submit PAIR reports
as required:
15 U.S.C. 2607 (a)(1)
15 U.S.C. 2614 (3) (B)
COUNT . . $ 68.378
COUNT V
False reporting of chemical substances
as manufactured for commercial purposes.
Respondent is sole submitter of each
chemical to EPA TSCA Inventory:
15 U.S.C. 2607 (a)(1)
15 U.S.C. 2614 (3) (B)
COUNT . . . . . ........ . . . . . . . . . $ 51. 000
TOTAL PROPOSED CIVIL PENALTY ......... $ 553,878

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—11—
NOTICE OF OPPORTUNITY TO
REQUEST A HEARING
As provided in Section 16(a) (2) (A) of TSCA, you have the
right to request a formal hearing to contest any material fact
set forth in this Complaint or to contest the appropriateness of
the proposed penalty. Any hearing requested will be conducted in
accordance with the Administrative Procedures Act, 5 U.S.C.
Section 551 et seq. , and the Consolidated Rules of Practice
Governing the Administrative Assessment of Civil Penalties , 40
CFR Part 22 ( “Consolidated Rules of Practice”) . A copy of the
Consolidated Rules of Practice accompanies this Complaint.
To avoid being found in default, which constitutes an
admission of all facts alleged in the Co&nplaint and a waiver of
the right to a hearing, and having the above penalty assessed
without further proceedings, you must file a written Answer
within twenty (20) days of receiving this Complaint . Pursuant to
the Consolidated Rules of Practice, your Answer must clearly and
directly admit, deny, and/or explain each of the factual
allegations contained in this Complaint with regard to which you
have any knowledge. If you have no knowledge of a particular
fact and so state, the allegation is considered denied. Failure
to deny any of the allegations in this Complaint will constitute
an admission of the undenied allegation.

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—12—
The Answer shall also state the circumstances and arguments,
if any, which are alleged to constitute the grounds of defense,
and shall specifically request an administrative hearing, if
desired. If you deny any material fact or raise any affirmative
defense, you will be considered to have requested a hearing.
The Answer must be filed with:
Headquarters Hearing Clerk (A—hO)
United States Environmental Protection Agency
401 M Street, S.W., Room M3706
Washington, DC 20460
Please send a copy of the Answer an all other documents which you
file in this action to Vincent Giordano, the attorney assigned to
represent EPA in this matter, at:
Toxics Litigation Division (LE—134P)
Office of Enfoccement and Compliance Monitoring
U.S. Environmental Protection Agency
401 M Street, S.W., Rm. WE 113A
Wasnlngton, D.C. 20460
INFORMAL SETTLEMENT CONFERENCE
Whether or not you request a hearing, you may confer
informally with EPA through Mr. Giordano regarding the facts of
this case, or amount of the proposed penalty, and the possibility
of settlement. An informal settlement conference does not,
however, affect your obligation to file a written Answer to the
Complaint.

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—13—
EPA has the authority, where appropriate, to modify the
amount of the proposed penalty to reflect any settlement reached
with you in an informal conference. The terms of such an
agreement would be embodied in a Consent Agreement and Final
Order (“CAFO”). A CAFO signed by EPA and you would be
binding as to all terms and conditions specified therein upon
signature by the EPA Chief Judicial Officer.
Please be advised that the Consolidated Rules of Practice
prohibit any ex parte (unilateral) discussion of the merits of
any action with the Administrator, Cnief Judicial Officer,
Administrative Law Judge, or any person likely to advise these
officials in the decision of the case, after the Compliant is
issued.
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or
requesting an informal settlement conference, you may choose to
pay the proposed penalty. Such payment should be made by
sending a cashier’s or certified check payable to the United
States of America in the amount of the penalty assessed in this
Complaint. The check should be mailed to:
EPA—Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251

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—14—
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
TSCA 89—H— 22
Compi a i nant
BY:
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring
Date:

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—15—
CERTIFICATION
I hereby certify that the original of the foregoing Complaint and
Notice of Opportunity for Hearing, Docket No. TSCA—89—H—22 , has
been filed with the Headquarters Hearing Clerk and that copies
were sent, registered mail, return receipt requested to:
Mr. David .7. Phillips
President
A]colac Incorporated
1099 Winterson Road
Linthicum Heights, MD 21090
_________ _M JoL
Date John E. Mason (EN—342)
Document Control Officer
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matterof:
3M COMPANY
(MINNESOTA MINING AND ) Docket No. TSCA-88—H-06
AND MANUFACTURING),
Respondent.
S
COMPLAINANT U.S. ENVIRONMENTAL PROTECTION
AGENCY’S PRE—HEARING EXCHANGE
By Letter dated October 5, 1988, as modified by Order
dated December 13, 1988, the Court directed Complainant
United States Environirental Protection Agency (EPA or the
Agency) and Respondent 3M Company (3M), the Parties hereto,
to file certain responses and documents by January 12, 1989
(the Pre—Mearing Exchanges). As this matter has not been
settled, Complainant responds as follows to the Letter and
Order .
I. Witnesses To Be Called And Brief Narrative Summary Of
Their Expected Testimony
1. Antony R. Ellis , Case Preparation Officer, Case Support
Branch, Cospliance Division, Office of Compliance Monitoring.
r. Ellis’ Program Description is attached hereto as Exhibit 12.
Mr. Ellis will testify concerning the case development
process for In the Matter of 3M Company . Mr. Ellis will

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outline chronologically all of the developments in this matter,
from Complainant’s first contact with 3M to the filing of the
Amended !int. Mr. Ellis will describe how the Complaint
in this matter was prepared, explain briefly the Sections of
TSCA violated by 3M, and show how the evidence in EPA’S
possession supports the violations alleged in the Complaint.
Mr. Ellis will also describe the process whereby the requisite
Agency concurrences on this action were obtained prior to the
filing of the Complaint , in accordance with established
Agency policy. Finally, Mr. Ellis will explain how he calculated
the adjusted proposed penalty in this case, and confirm that
the penalty was calculated in accordance with the TSCA Section
5 and TSCA Sections 8, 12, and and 13 Enforcement Response
Policies (Exhibits 17 and 18).
2. J. Mark Scoville, Jr. , TSCA Inventory Specialist, Chemical
Inventory Section, Confidential Data Branch, Information
Manangement Division, Office of Toxic Substances. Mr. Scoville’s
Program Description is attached hereto as Exhibit 12.
Mr. Scoville is one of the Agency’s foremost experts on
TSCA Inventory matters, having worked on Inventory issues since
the inceptt n of the Inventory in 1979. Mr. Scoville has
personally nducted numerous searches of the TSCA Inventory,
including the confidential portion of the Inventory not
accessible by the general public. Mr. Scoville will explain
how Inventory searches are conducted. Mr. Scoville will then
testify with respect to the Inventory searches conducted in

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connection with this case, described in the Certified Statements
of Linda A. Travers, Director, Information Management Division
(Exhibits 2 and 6). Mr. Scoville will confirm that the
Inventory searches are accurate and thereby demonstrate
conclusively, as of the dates of the searches, the new chemical
status of the 2 chemicals subject to this enforcement action
(1—86—209 and 1—86—250). The two chemicals were “new chemical
substances” until September 23, 1986, and October 7, 1986,
respectively.
3. James W. Long , Economist, Regulatory Impacts Branch.
Economics and Technology Division, Office of Toxic Substances.
r. Long’s Curriculum Vitae is attached hereto as Exhibit 19.
Mr. Long is a professional economist with special expertise
in the area of econanic cost—benefit analysis and regulatory
impact analysis. Among his accomplishments are his contributions
to the “Regulatory Impact Analysis (RIA) for Title III of
Sections 322 and 323 of the Superfund Amendments and Reauthorization
Act of 1986” (Exhibit 20). In connection with the RIA, Mr.
Long oversaw the development of an economic profile of those
businesses in the Standard Industrial Classification (SIC)
Code 28—XX ckemica1 manfacturers). 3M Company is included
in this S!&Cod.. Mr. Long’s testimony regarding this economic
profile will illuminate the issue of the proper levels of
penalties to deter regulatory violations by the community of
persons subject to premanufacture reporting. In addition,
Mr. Long will discuss the impact of representative penalties

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calculated in accordance with the TSCA Section 5 and Sections
8, 12, and 13 ERPs on the ability of SIC Code 28—XX firms to
“pay the penalties” and “continue in business” 1
r. Long -will also testify specifically regarding the
impact of the adjusted proposed penalty in this case on 3M.
The context of the discussion will include not only “ability
to pay” and “ability to continue in business”, but the deterrence
effect the penalty may be expected to have on 3M. Mr. Long
will testify that, by any reasonable analysis, the impact of
this penalty on 3M can only be characterized as minimal. In
support of this conclusion, Mr. Long will discuss publicly
available information, obtained by EPA, on 3M’s financial
status. The information is based on documents filed by 3M
before the U.S. Securities and Exchange Commission (Exhibit
21). The information supports Complainant’s conclusion that
the expected impact of the penalty on 3M will be minimal.
To place the information in the context of “everyday
life”, Mr. Long will compare the impact of the adjusted
proposed penalty on 3M with the impact an equivalent penalty
would have on a natural person earning $67,038 per year before
taxes. Mr. Long will calculate that, in these terms, based
on 3M’s evEious income before taxes ($1,565,000,000.00),
the impact of the adjusted proçosed penalty on 3M is roughly
equivalent to the natural person paying a penalty of approximately
55 dollars and 96 cents (ExhibIts 21, and 22).

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4. Phyllis E. Flaherty , Acting Director, Policy and Grants
Division, Office of Compliance Monitoring. Ms. Flaherty’s
Curriculum Vitae is attached hereto as Exhibit 23.
Ms. F1ah rty is a recognized expert in EPA enforcement
issues, with over 12 years experience in this field. Ms.
Flaherty is presently the manager of the division within the
Office of Compliance Monitoring responsible for the development
of the Agency’s media—specific enforcement guidance for TSCA
civil administrative enforcement actions, and in particular
the TSCA Section 5 and Sections 8, 12, and 13 ERPs.
Ms. Flaherty will testify that the ERPs, and th September
10, 1980 Guidance document, were developed in accordance. with,
and conform to, the penalty factors in TSCA Section 16. She
will explain how the ERPS comport with general Agency guidance
regarding the assessment of civil penalties. Among the most
important points Ms. Flaherty will emphasize is how the ERPs
directly address the “potential harm, and actual harm,
associated with the illegal import of new chemical substances.
She will also explain that it is inappropriate to place
penalty amount caps on the proposed penalties for this
genre of violations.
Ms. F2 rty will address directly the need for firm
enforcement of the TSCA Section 13 import certification
requirements. Ms. Flaherty will emphasize that the Agency’s
TSCA Section 13 enforcement policies parallel the Congressional
intent, as manifested in TSCA Sections 13, 15, and 16, that

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violations of TSCA Section 13 be considered separate and
distinct violations. Ms. Flaherty will explain that the TSCA
Sections 8, 12, and 13 ERP is specifically intended to address
the Agency’s oncern that importers of chemical substances
are often not themselves the manufacturers of the chemicals
(and may therefore be less familiar with the TSCA premanufacture
notification requirements), and/or tend to rely on heresay
information or unchecked assumptions regarding the Inventory
status of the imported chemicals, in place of personally
conducting effective Inventory searches prior to import (as
did 3M). For these and other reasons, the affirmative import
certification requirements imposed on importers (but not
domestic manufacturers) are considered an integral part of
EPA’S overall strategy to effectively enforce the TSCA Section
5 premanufacture notification requirements.
5. Wendy Cleland—Hamnett , Deputy Director, Chemical Control
Division, Office of Toxic Substances. Ms. Cleland—Haxnnett’s
Curriculum Vitae is attached hereto as Exhibit 27.
Ms. Cleland—Hamnett, having been professionally involved
in the TSCA Section 5 new chemicals program since its inception
in 1979, ii ong the most krtowledgable EPA managers in this
field. Ni...Clsland—Hamnett will testify as to the critical
importance of the new chemicals program in the Agency’s
chemical regulation strategy, in the context of Agency enforcement
guidance stressing the importance of the violated regulatory

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scheme as a key factor in generating an appropriate penalty.
Ms. Cleland—Hamnett will also explain the multidisciplinary
process whereby EPA determines the potential for new chemical
substances toexhibit toxicity, calculates probable exposure
levels, identifies data gaps, synthesizes and analyzes the
results, and determines whether further regulatory action is
appropriate. Such action is appropriate, Ms. Cleland—Hamnett
will testify, when EPA can determine that there is “insufficient
information to permit a reasoned analysis of the health of
environmental effects” of the substance”, and either (1) the
manufacture, import, processing, distribution in commerce, use
and disposal of the substance “may present an unreasonable
risk of injury to human health or the environment”, or (2)
the substance “will be produced in substantial quantities”
and “may reasonably be anticipated to enter the environment
in substantial quantities or there ... may be significant or
substantial human exposure to the substance”. TSCA Section
5(e)(l)(A)(i) and (ii). Upon making these findings, EPA may
issue an order prohibiting or limiting the activities involving
the substance pending the development of additional data to
address th. potential risk.
MS. C4!ind—Hantitett will emphasize that that the raison
de etre of TSCA Section 5 Is to address potential , as opposed
to actual, risk. EPA accomplishes this, inter alia , by
identifying data gaps before there Is exposure to, or investment
in, the chemicals. Consequently, the gravity of 3M’s violations

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can properly be considered oniy in the context of the prospective
prevention of upotential harm which is the focus of the new
chemicals program.
Ms. Cleland—Hamnet is presently on detail to the immediate
staff of the Administrator. Depending on her availability on
the day of the hearing, Lawrence E. Culleen, Chief, Premartufacture
Notice Management Branch, Chemical Control Division, Office of
Toxic Substances, may testify as to the above matters in place
of Ms. Cleland—Hamnett. Mr. Culleen’s Curriculum Vitae is
attached hereto as Exhibit 28.
6. Charles M. Auer , Deputy Director, Health and Environmental
Review Division (HERD), Office of Toxic Substances. Mr. Auer’s
Curriculum Vitae Is attached hereto as Exhibit 30.
Mr. Auer, who has been associated with the new chemicals
program since its inception in 1979, manages the review of
new chemical substances for potential health and environmental
effects, and participated in the development of the Premanufacture
Notification Exemption for Polymers at 40 CFR S723.250 (the
polymer exemption rule). Mr. Auer will testify concerning
the process whereby HERD reviews new chemical substances for
potential h.ulth and environmental effects. Mr. Auer will
testify th.e, statistically speaking, polymers encompassed by
the polymer exemption rule are less likely to present unreasonable
risks than are lower molecular weight substances. The TSCA
section 5 ERP takes this factor into account by permitting

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substantially reduced penalties for polymeric Substances,
Exhibits 14 and 15 describe how the adjusted proposed penalty
in this case is over half a million dollars less than an
equivalent penalty for a non—polymer.
Mr. Auer will also explain, however, that many polymers
do exhibit sufficient toxicity to trigger EPA concerns under
TSCA Section 5. For this reason, Mr. Auer will testify that
EPA found it essential, in drafting and promulgating the
polymer exemption rule, to review each new polymer individually.
in addition, EPA reserved the right to subject any polymer to
the full 90—day Premanufacture Notice (PMN) review set forth
in 40 CFR Part 720, under appropriate circumstances. In this
context, Mr. Auer will explain that polymers may exhibit
toxicity to humans, fauna, or flora, and will provide specific
examples of such toxicity with reference to, among other
things, polymers actually reviewed by EPA’S new chemicals
program.
7. Dwain Winters , Acting Director of Budget, Office of
Program Management and Evaluation, Office of Toxic Substances.
The Program Description of the Office of Program Management
and Evaluatjon is attached hereto as Exhibit 32.
Mr. Wiatsre has been employed with EPA since its inception
in 1970. In addition to his present position as Director of
OPME, Mr. winters has served as a program analyst for the
Budget Office of the Assistant Administrator of Air, Noise,
and Radiation (1977—1982), and as the Director of the Office

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of Toxic Substances Policy Staff (1987—present). In these
positions, Mr. Winters has developed considerable expertise
in budget matters.
Mr. Winters’ testimony, like Ms. Cleland—Ramnett’s, will
reinforce the critical importance EPA places on the TSCA
Section 5 new chemicals program. Mr. Winters, however, will
approach the issue from a different angle. Mr. Winters, using
hard budget data generated by the Comptroller’s Office (Exhibit
33), will testify that both the Congress and EPA have stressed
the importance of the program by consistently allocating
sufficient resources to enable the Office of Toxic Substances
to achieve all of the significant goals of the program.
Mr. Winters will testify that the resources expended on
the new chemicals program are substantial in absolute terms.
Mr. William’s will emphasize, however, that the the best
measure of ‘program significance’, in budgetary terms, is the
relationship of the resources allocated compared to the
resources needed to accomplish the job. In this context, the
new chemicals program must be viewed as a critical one, as
the budget figures demonstrate a mature, yet still growing
program which, as Ms. Cleland—Hamnett will testify, has
for many y’s comp1ished its goals in a timely manner.
8. Other Witnessesi Complainant does not, at this time,
anticipate the need to call any additional witnesses. Complain
respectfully reserves the right, however, to supplement its
witness list upon adequate notice to Respondent and the Court.

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II. Documents and Exhibits to Be Introduced Into Evidence
Exhibit 1: Response of Information Management Division (IMD),
Confidential Data Branch (CDB), Chemical Inventory
Section (CIS) to 3M Bona Fide Intent to Manufacture
inquiry for 1—86—209; TSCA Confidential Business
Information (CBI) Document Control No. 59—86000715.
Re ponse states that Y—86—209 does not appear on
the TSCA Inventory of Existing Chemical Substances
Master File (Inventory), thereby establishing
1—86—209’s status as a new chemical substance
subject to TSCA Section 5.
Exhibit 2: Certified Statement of Linda A. Travers, Director,
IMD, dated September 23, 1986; TSCA CBI Document
Control No. 20860002514. Statement provides that
the chemical substance Y—86—209 was not included on
the Inventory as of September 23, 1986.
Exhibit 3: (1) Memorandum entitled, “Request for an Expedited
Safety Review of a Chemical Substance (Y—86—209 ”,
from A. C. Conroy II, Director, Office of Compliance
Monitoring (0CM) to Rick Tinsworth, Acting Director,
Office of Toxic Substances COTS), dated August 1,
1986; and (2) Memorandum entitled, “Safety Review
[ of Y—86—209], from Rick Tinsworth, OTS, to A. E.
Conroy II, dated July 31, 1986.
Exhibit 4: Letter from John J. Neylan III, Director, Compliance
Division, 0CM, to 3M, dated August 6, 1986. Letter
authorizes 3M to continue to process and distribute
1—86—209 pending expiration of the 21—day polymer
exemption application (PEA) review period.
Exhibit 5: Response of IMD, CDB, CIS to 3M Bona Fide Intent
to Manufacture inquiry for 1—86—250; TSCA Confidential
Business Information (CBI) Document Control No.
59—86000225. Response states that 1—86—209 does
not appear on the Inventory, thereby establishing
Y—86—209’s status as a new chemical substance
subject to TSCA Section 5.
Exhibit 6s ? Crtif fed Statement of Linda A. Travers, Director,
IND, dated October 21, 1986; TSCA CBI Document
Control No. 20—870000116. Statement provides that
the chemical substance 1—86—250 was not included on
the Inventory as of October 7, 1986.

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Exhibit 7:
Exhibit 8:
Exhibit 9:
Exhibit 10:
Letter from 3M to John J. Neylan, III, 0CM, dated
September 17, 1986; TSCA CR! Control No. HEN—293—86.
Letter requests permission to continue to process
and use y—86—250 pending expiration of the 21—day
PEA review period.
(1) Memorandum entitled, “Request for an Expedited
Safety Review of a Chemical Substance [ Y-86—2501”,
from A. E. Conroy II, Director, Office of Compliance
Monitoring (0CM) to Rick Tinsworth, Acting Director,
Office of Toxic Substances COTS), dated September
19, 1986; and (2) Memorandum entitled, “Safety
Review (of Y—86—2501 ”, from Rick Tinsworth, OTS,
to A. E. Conroy II, dated September 24, 1986.
Letter and enclosures, from 3M to John J. Neylan, III,
0CM, dated November 18, 1986, TSCA CBI Control No.
HEN—162—87. In this letter, entitled “Documents
and Facts Concerning Import of 1—86—209”, 3M confesses
to, and documents, all of the violations involving
Y-86—209 alleged In the Amended Complaint .
Letter and enclosures, from 3M to John J. Neylan, III,
0CM, dated November 7, 1986, TSCA CBI Control No.
HEN—161—87. In this letter, entitled “Documents
and Facts Concerning Import of 1—86—250”, 3M confessee
to, and documents, all of the violations involving
1—86—250 alleged in the Amended Complaint .
Exhibit 11: Letter and enclosure, from 3M to Antony (Tony)
F llis, 0CM, dated September 4, 1987; TSCA CR!
Document Control No. HEN—159—87. Letter contains
use information on 1—86—209 and 1—86—250.
Exhibit 12: Program Description (PD) for Antony R. Ellis,
Case Preparation Officer, 0CM, Compliance Division,
Case Support Branch (CSB). The PD describes Mr.
Ellis’ professional duties and responsibilities.
Exhibit 13: Penalty Calculations Worksheet, dated August 30,
1988. Worksheet describes in detail the bases for
, the adjueted proposed penalty in the original
.9.!2. Li.flt ($1,394,500).
Exhibit 14i Penalty Calculations Worksheet, dated October 19,
1988. Worksheet describes in detail the bases for
the adjusted proposed penalty in the Amended
Complaint ($1,306,500).

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Exhibit 15: Penalty Calculations Worksheet, dated January 9,
1989. worksheet describes in detail how the
adjusted proposed penalty in this case would
have been calculated had the Gravity Based
Penalty (GBP) component not been significantly
reduced in the Amended Complaint to reflect the
status of 1—86—209 and Y—86—250 as polymers
(Si ,867,250).
Exhibit 16: Penalty Calculations Worksheet, dated January 9,
1989. Worksheet describes in detail how the
the adjusted proposed penalty in this case would
have been calculated had the Gravity Based Penalty
(GBP) component not been significantly reduced
in the Amended Complaint to reflect the fact
that EPA’S review of 1—86—209 and 1—86—250 did
not identify any unreasonable risks of injury to
human health or the environment (S2,8l1,500).
Exhibit 17: “TSCA Section 5 Enforcement Response Policy (EPP),
dated August 5, 1988. The adjusted proposed penalty
in the Amended Complaint for the TSCA Section.5
premanufacture notification violations was calculated
in full accordance with the TSCA Section 5 ERP.
Exhibit 18: “Recordkeeping and Reporting Rules, TSCA Sections
8, 12, and 13 Enforcement Response Policy (ERP),
dated May 15, 1987. The adjusted proposed
penalty in the Amended Complaint for the TSCA
Section 13 import certification violations was
calculated in full accordance with the TSCA
Section 13 ERP.
Exhibit 19: Curriculum Vitae, James W. Long, Economist, OTS,
Economics and Technology Division (ETD), Regulatory
Impacts Branch. -
Exhibit 20: Excerpts from the NRegulatory Impact Analysis in
Support of the Final Rulemaking Under Sections
322—323 of Title III of the Superfund Amendments
and Reauthorization Act of 1987, as updated by
Mr. Long. The excerpts establish the median
sales of businesses in Standard Industrial
Classification (SIC) Code 28—XX, which includes
3M and other producers of new chemical substances.
The economic status of this regulated community
is relevant to the issue of the level of penalties
necessary to deter regulatory violations, and the
typical impact of penalties calculated in accordance
with the TSCA Section 5, and TSCA Sections 8, 12, and
13 ERP5 on regulated entities in general.

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Exhibit 21: Disclosure Information Retrieval Service: 3M File.
This file provides information on numerous important
economic indicators, based on information filed by
3M with the U.S. Securities and Exchange Commission.
The information addresses the impact of the adjusted
proposed penalty on 3M, including lack of significant
impact on 3M’s ability to pay and ability to continue
in business.
Exhibit 22: Worksheet: In the Matter of 3M Company: Relative
Impact of Adjusted Proposed Penalty. This Worksheet
demonstrates that the impact of the adjusted
proposed penalty in this case on 3M is roughly
equivalent to the impact a similar adjusted
proposed penalty of approximately $55.96 would
have on a natural person earning $67,038 per year.
The conclusion to be drawn therefrom is that the
impact of the adjusted proposed penalty on 3M is
minimal. The Exhibit is also relevant to the
issue of the deterrent effect the penalty may be
expected to have on 3M.
Exhibit 23: Curriculum Vitae. Phyllis E. Flaherty, Acting. Director,
0CM, Policy and Grants Division.
Exhibit 24: “Guidelines for the Assessment of Civil Penalties
Under Section 16 of the Toxic Substances Control
Act”, 45 Fed. Reg. Reg. (September 10, 1980).
Exhibit 25: (1) Memorandum entitled, “New Civil Penalty
Policy”, from Courtney Price, Assistant Administrator,
to Addressees, dated February 16, 1984; and
(2) “ Policy on Civil Penalties : EPA General
Enforcement Policy *GM—21 ”, dated February 16, 1984.
Exhibit 26: “ A Framework for Statute—Specific Approaches to
Penalty Assessments : Impementing EPA’S Policy
on Civil Penalties: EPA General Enforcement
Policy *GM—22’, dated February 16, 1984.
Exhibit 27: Curriculum Vitae, Wendy Cleland—Ramnett, Deputy
Director, Chemical Control Division (CCD), OTS.
Exhibit 28s Curriculum Vitae, Lawrence Culleen, Chief,
Premanufacture Notice Management Branch (PNMB),
CCD, OTS.
Exhibit 29: “New Chemical Review Process Manual”, dated March,
1986. The Manual describes in detail the review
process for new chemical substances, including
polymers, in effect at the time of 3M’s TSCA Section
5 violations. To the extent current practices
may differ with the Manual, they will be identified
by Ms. Cleland—Hamnett or Mr. Culleen.

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Exhibit 30: Curriculum Vitae, Charles M. Auer, Deputy Director,
Health and Environmental Review Division (HERD),
OT S.
Exhibit 31: Charles M. Auer and David H. Gould, “Carcinogenicity
Assessment and the Role of Structure Activity
Relationship (SAR) Analysis Under TSCA Section 5”,
F.nvir. Carcino. Revs. (J. Envir. Sci. Hith.),
C5(l), 29—71 (1987). Mr. Auer will refer to, and
explain this article in his testimony.
Exhibit 32: Program Description (PD) for Dwain Winters,
Director of Budget, Office of Program Management
and Evaluation (OPME), OTS. The PD describes
OPME’s duties and responsibilities.
Exhibit 33: Excerpts from U.S. Environmental Protection
Agency Budget Analysis Resource System: FY8O—88
Actuals: Pesticides and Toxic Substances. The
excerpts describe actual levels of funding over
time, in terms of both Full Time Employees (FTE’s)
and Intramural and Extramural Dollars, for the
new chemicals program. The figures are relevant
to the N(ilmportance to the regulatory scheme,
(‘,M—22 at 14 (Exhibit 26), of the sections of TSCA
violated by 3M.
Exhibit 34: Program Description (PD) for 3. Mark Scoville, Jr.,
TSCA Inventory Specialist, Chemical Inventory Section,
Confidential Data Branch, IMD, OTS.
Complainant does not, at this time, anticipate the need
to introduce any further evidence. Complainant respectfully
reserves the right, however, to supplement its exhibit list
upon adequate notice to Respondent and the Court. In addition,
Complainant may request the Court to take official notice of
appropriat stters in accordance with 40 CFR S22.22(f).
III. Location of the Hearing
Complainant respectfully requests that the hearing in
this matter be held in Washington, D.C.

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IV. TSCA Inventory of Existing Chemical Substances
The TSCA Inventory is a lengthy and detailed document
which lists literally thousands of chemical substances. Many
of these substances are TSCA Confidential Business Information
which Complainant is prohibited by TSCA Section 14 from
revealing to the Respondent, absent a bona fide intent to
manufacture as defined in 40 CFR S720.25(b)(2). Therefore,
Complainant has not included a copy of the Inventory in this
Pre—Hearing Exchange.
To comply with the Court’s directive, Complainant has
filed, inter alia , Exhibits 2 and 6, which are the Certified
Statements of Linda A. Travers, the Director of the OTS
Information Management Division, that 1—86—209 and 1—86—250
were not listed on the Inventory at the time of 3M’s violations.
In addition, Complainant’s second witness, Mr. Scoville, will
testify regarding the accuracy of the Inventory searches
described in Ms. Travers’ Certified Statements, and explain in
detail how the Inventory searches were conducted.
V. Written Statements Furnished by 3M to Customs Officials
compl.#nant has not endeavored to obtain the written
statements vhich 3M furnished to the U.S. Customs officials
from the Customs Service because the statements, as a matter
of law, must have been false in this case. As explained In
40 CFR S707.20(2)(i) and (ii), any import of a chemical
substance must be certified with the Customs Service, and

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only two certifications are permitted. They are: (1) the
chemical substance complies with all applicable rules or
orders under TSCA, or (2) the chemical substance is not
subject to TSCA. See also 19 CFR SS12.118—12.127. Since the
chemical substances in this matter were subject to TSCA, and
3M illegally imported them in violation of TSCA Section 5,
there is no possible scenario in this case in which 3M could
have not violated the import certification requirements.
Furthermore, 3M, in documents provided to EPA (Exhibits 9 and
10), and in the Second Amended Answer , has admitted that 3M
caused the false certifications to be made.
VI. Response to Paragraphs 1, 5, 8, 9, 10, 14, 18, 21, 22,
and 23 of the Second Amended Answer
Paragraphs 5, 10, 18, and 23 of the Second Amended
Answer describe two polymer exemption applications for the
two new chemicals, which 3M submitted to EPA pursuant to 40
CFR §723.250. These polymer exemption applications were
submitted to EPA after the violations set forth In the Amended
Complaint occurred, and so are Irrelevant to 3M’s liability
in this mat* . EPA confirms that the review period for both
substances1I ired without EPA imposing any restrictions on
subsequent manufacture, Import, and use of the substances.
For this reason, Complainant has proposed signI ficantly lower
penalties in this matter than authorized by law. Compare
Exhibits 14 and 16.

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The two submissions described in Paragraphs 1, 8, 9, 14,
21, and 22, constitute Complainant’s Exhibits 9 and 10.
Complainant has already adjusted the Gravity Based Penalties
•in this mattet downward by a full 50% to reflect 3M’s prompt
confession to EPA of the violations documented in Exhibits
9’and 10.
VII. Import of Chemical Substances As Part of Mixtures
On December 13, 1988, in response to Paragraphs 7 and 13
of the Second Amended Answer , and the affirmative defense
“Computation of Count I Alleged Violation”, Second Amended
Answer at 16-17, Complainant moved to amend the Complaint to
eliminate all pre—August 30, 1980 TSCA Section 5 violations
involving chemical substances imported as part of mixtures.
By Order dated December 23, 1988, the Court authorized the
amendment. This matter is therefore no longer at issue.
VIII. Complainant’s Response to the Section of Respondent’s
Second Amended Answer Entitled, “The Proposed Civil
Penalties ’
Complainant has carefully reviewed the section of 3M’s
Second Am.ndsd Answer entitled, “The Proposed Civil Penalties”.
Complainant’s responses to the affirmative defenses entitled,
“Statutes of Limitations (Counts I & III)” (at 14—15),
“Substantive Due Process and Equal Protection” (at 16), and
“Excessive Fines” (at 16), are set forth in Complainant’s

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December 29, 1988 Memorandum of Points and uthorities in
Support of Motion to Strike Affirmative Defense , and January
6, 1989 Memorandum of Points and Authorities in Support of
Second Motion to Strike Affirmative Defenses , incorporated
herein by reference. The affirmative defense entitled,
“Computation of Count I Alleged Violations” is no longer at
issue in this case. See Section VII, supra .
Complainant considers the remaining defenses in the
Second Amended Complaint to lack merit. A point—by—point
response follows. The responses are intended to provide the
Court and 3M with full and fair notice of Complainant’s
positions on these matters. To the extent 3M’s defenses have
not been stricken prior the exchange of post—hearing briefs
pursuant to 40 CFR S22.26 , Complainant will elaborate at that
t i me.
1. 3M believed in good faith that 1—86—209 and 1—86—250 were
on the Inventory when 3M imported them.
To Complainant’s best knowledge, this statement is
accurate. It does not, however, provide a defense to the
penalty a sp.nt in this case. EPA assumed good faith on the
part of 3M In selecting a civil administrative action as the
appropriate enforcement response in this case, and generating
the adjusted proposed penalty per the TSCA Section 5 and Sections
8, 12, and 13 ERPe.

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A company which knowingly and willfully imports chemicals
in violation of TSCA may be subject to criminal penalties
pursuant to TSCA Section 16(b), as well as increased civil
penalties. No such responses are contemplated in this case,
because there is no evidence to support any finding of “knowing
and willful” misconduct on the part of 3M.
2. 3M ceased to import the chemicals when it learned that the
chemicals might not be on the Inventory.
t the point where 3M learned that the chemical might not
be on the Inventory, 3M had “reason to know” that the import
activities were in violation of TSCA. Complainant rejects
3M’s assertion that 3M now deserves to be rewarded with a
further reduction in the adjusted proposed penalty for taking
what Complainant considers to be the absolute minimum prudent
and legally required action of ceasing the violative activities,
pending a search of the Inventory and the review of the
substances by EPA.
3. The illegally imported chemicals never presented an actual
risk to h.a th or thi environment.
4. EPA reviewed notices (polymer exemption applications) for
Y—86—209 and Y—86—250 and cleared both chemicals with no
restrictions whatsoever.

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—21—
Complainant is most relieved that 3M’s violations in
this matter did not appear to present any health or environmental
risks, and that EPA was able to clear the chemicals without
extending the review periods and regulating the substances
under TSCA Section 5(e) or Cf). Complainant repeats that the
Gravity Based Penalty in this matter is based on these findings.
Compare Exhibits 12, 13, and 14.
in this context, Complainant wishes to express its heartfelt
prayer that we are never faced with a TSCA Sections 5 and 13
enforcement action in which actual injury is a factor in the
case. Complainant is certain that the Parties are in complete
accord on this score. Complainant views the enforcement of this
case, and the imposition of the full adjusted proposed penalty,
as promoting this result by emphasizing to 3M and the regulated
community the importance of complying with the TSCA premanufacture
review requirements.
5. 3M has cooperated fully with EPA regarding this case.
Complainant agrees that 3M promptly self—confessed its
illegal activities to EPA upon learning of them, and has
provided EPI with documentation of the violations upon request.
in recognittOn of this cooperation, Complainant has reduced the
Gravity Based Penalty in this case by a full 50%. Complainant
feels that this adjustment is most significant and adequately
recognizes the degree of cooperation which 3M has exhibited
to date in this matter.

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—22—
6. 3M did not derive any significant economics benefits from
its illegal activities.
EPA’S enforcement policies consistently provide for
civil penalties to be increased to recapture any economic
benefits of non—compliance. See GM *21 (Exhibit 25) at 3,
GM *22 (Exhibit 26) at 4, 11—12, and the September 10, 1980
“Guidance” (Exhibit 24) at 59774—5. The policies however, do
not, and should not, provide for penalties to be further
reduced due to lack of “gains from non—compliance”. Complainant
has therefore neither increased nor decreased the penalty in
this case based on the “gains from non—compliance” factor.
7. The TSCA—specific “Guidance” and ERPS are inconsistent with
GM—21 and GM—22.
This statement is at best, irrelevant. Moreover, it is
inaccurate.
GM—21 states:
“The policies and procedures set out in this document
and in (GM—22] are intended soley for the guidance of
government personnel. They, are not intended and cannot
be relied upon to create any rights, substantive or
procedural, enforceable by any party in litigation with
the U4t.d States. The Agency reserves the right to act
at vaetanc. with these policies and procedures and to
changs them at any time without public notice.”
GM—21 at 7. This language speaks for itself.

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The cover memo to the policies, signed by the Assistant
Administrator of the Office of Enforcement and Compliance
Monitoring, further provides: ‘No attempt is made to address
issues specific to each statute the Agency administers. Instead,
this will be left to guidance developed by each program.’ Id.
at 1. See also GM—21 at 1—2. The ‘Guidance’ and ERPS which
Complainant used to calculate the adjusted proposed penalty
in this case constitute precisely such ‘program—specific
guidance.’ Moreover, because the Office of Compliance Monitoring
has been formally delegated the authority to develop and
issue such program—specific guidance by the Administrator,
and the guidance was developed and issued in strict accordance
with all applicable intra—Agency concurrence procedures, to the
extent the TSCA—specific policies may in fact deviate from the
general Agency—wide guidance, the deviations have been reviewed
and formally approved by the Agency. The TSCA—specific documents
thus represent the final word on Complainant’s position
regarding the appropriateness of the adjusted proposed penalty
in this case.
The TSCA—specific guidance is in fact consistent with
the GM—series policies with respect to the most Important aspects
of the GM—series policies. Complainant’s witnesses will
testify in detail regarding these and other factors:
1. ‘The first goal of penalty assessment is to deter
people from violating the law.’ GM—21 at 3.
2. (TJhe penalty should persuade the violator to
- take precautions against falling into non—compliance
again (specific deterrence).’ Id.

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3. ‘(The penalty should also] dissuade others from
violating the law (general deterrence).” Id.
4. ‘Fair and equitable treatment requires that the
Agency’s penalties must display both consistency
and flexibility. The consistent application of a
penalty policy is important because otherwise the
resulting penalties might be seen as being
arbitrarily assessed.’ Id. at 4
5. “ Gravity Component . [ Tihe following factors should
be considered:
a. actual or possible harm
b. importance to the regulatory scheme ...“ GM—22 at 3.
6. “ Size of violator: ’ Id. at 15.
7. “ The length of time a violation continues: ’ Id.
This is, of course, only a partial listing of the penalty
factors in the two GM—series documents. 3M may direct questions
to Complainant’s witnesses regarding any other factors at the
hearing.
One additional word on ‘consistency’: It is said that,
“one cannot have his cake and eat it too.’ The TSCA ERPs are
progressive in a number of important ways. The 50% self—confessor
adjustment included in the Amended Complaint in this case, for
example, is not routinely available in complaints for enforcement
of violations in other other environmental media, i.e., Clean
Water P t c p1aints. It is not difficult to imagine what
3M’s respon would be if Complainant, in response to the
‘GM—series’ defense, eliminated the self—confessor reductions
in this case. It appears that 3M is more than willing to
tolerate program—specific differences when it suits 3M’s
purposes to do so.

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8. “ Inventory Reporting (Count I) ”
This curious defense would have the Court reduce the
adjusted proposed penalty in this case to reflect the fact
that 3M not only violated the pren anufacture notification
requirements, but the Inventory Reporting Rule as well.
Not only does this assertion violate “the well—worn adage
that ‘two wrongs do not make a right’”, Gray v. Mississippi ,
481 U.S. —, 95 L. Ed. 2d 622, 636 (1987), it ignores EPA’s
attempts, in the early days of the Inventory, to bend over
backward to accomodate late reporters. Furthermore, 3M’s
suggested approach would serve to discourage persons who
manufacture or import large quantities of chemicals over long
periods of time from ever taking a second look at their
continuing activities in light of the magnitude and duration
of the activites.
3M cannot insulate itself from liability for its
premanufacture notification violations by having violated the
Inventory Reporting Rule. In fact, as EPA has stated
repeatedly, the opposite is true: a chemical substance not
listed on th. Inventory for any reason is by operation of law
a “new chia ca1 substance subject to the premanufacture
notificati requirements.
EPA provided early notice of these requirements in
numerous Federal Register Notices, including “Inventory
Reporting; Statement of Policy”, 45 Fed. .!! ‘ 26452 (April
18, 1980). In fact, EPA did not, at first, strictly enforce

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—26—
the TSCA Section 5 premanufacture notification requirements
for an 11 month period from July 1, 1979 to May 19, 1980,
specifically to provide all manufacturers and importers with
an additional opportunity to recheck the Inventory status of
their chemicals. Furthermore, as discussed supra , EPA did
not apply the TSCA Section 5 requirements to new chemicals
imported as parts of mixtures until August 30, 1980. 3M
should therefore accept the responsibility for the fact that
it chose not to avail itself of these repeated opportunities
to come into compliance with the law.
The April 18, 1980 Notice informed all manufacturers
and importers that, effective May 19, 1980, the premanufacture
notification requirements would become effective, and late
Inventory reports would no longer be accepted. EPA stated:
“EPA’S Office of Enforcement will strictly enforce
this deadline, and will assess penalties under section
16 of TSCA against any person found to be in violation
of the statutory and regulatory requirements of TSCA
concerning premanufacture notification.’ Id.
In a second Notice entitled. ‘Availability of TSCA Revised
Inventory’, 45 Fed. . 50544 (July 29, 1980). EPA again
informed all manufacturers that late Inventory reports would
no longer accepted. EPA repeated this information in other
published documents and on numerous occasions.

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—27—
3M appears to hold the opinion that once a manufacturer
or importer makes an Inventory determination, even where the
determination is not based on a personal search of the Inventory
but relies on unchecked assumptions or heresay, the person need
never consider revisiting the matter regardless of the person’s
continuing manufacture or import of the substance over many
years. This is bad law, it is bad policy, and it is not
acceptable to the Complainant.
9, PMN Reporting (Count III) :
The above arguments also apply to the issue of the
appropriateness of penalty 0 caps’ given 3M’s continuing Illegal
import of new chemical substances over time. Complainant has
explained supra the prospective focus of TSCA Section 5 with
respect to potential. risk. Complainant repeats herein that
Complainant is relieved that no actual risk occured, as the
result of the 3M’s TSCA violations, this time .
Experience dictates however, that potential exposure,
and therefore potential risk, may be directly proportional to
the quantity, and number of batches produced, of a toxic
chemical substai e. Experience further dictates that chemicals
for which thsr• may be no immediate reason to suspect the
potential for health or environmental risks may later be
determined to present serious risks. The legislative history
of TSCA is replete with such examples. This is, In fact, the
bottom line of what is really at stake in this case.

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Furthermore, “potential. risk” does not manifest “for
subsequent days at decreasing levels”, Second Amended Complaint
at 12—13. Neither should the penalties for 3M’s repeated
illegal imports in this case.
10: “ Import Certifications (Counts II and IV) ”
A summary of the reasons why it is critical that the
import certification violations, which even 3M does not deny
are clearly discrete TSCA violations, are separately penalized,
appears supra in the discussion of Complainant’s fourth
witness, Ms. Flaherty’s, intended testimony.
11. “ Administrative Procedure Act
3M’s contention that the TSCA Section 5 and Sections 8,
12, and 13 ERPS operate as “binding rules”, Second Amended
Answer at 15, is legally unsupportable. Even if it is assumed
that Complainant has calculated every TSCA penalty ever
proposed strictly according to the ERPs, the proposed penalty
in this case, in and of itself, imposes absolutely no legal.
obligation on 3M. Of course, the adjusted proposed penalty
in this ca was calculated by an Agency enforcement official
in the performance of his professional duties, and so is
entitled to the requisite deference. It is in the end analysis,
however, the Administrative Law Judge (AU) or Chief Judicial
Officer who will issue the Final Order in this case, not the

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Complainant. See 40 CFR §S22.27-.32. By that time, 3M will
have had its day in court.
IX. The Adjuited Proposed Penalty Accords With All Applicable
Penalty Guidelines and Enforcement Response Policies (ERPs )
The Penalty Calculation Worksheet in this action, attached
hereto as Exhibit 14, outlines how the adjusted proposed
penalty in this case was calculated. The calculations therein
are based on the “Guidelines for the Assessment of Civil
penalties Under Section 16 of TSCA”, and TSCA Section 5 and
Sections 8, 12, and 13 ERPs, attached hereto as Exhibits 17,
18, and 24, respectively.
Complainant’s first witness, Mr. Ellis, personally
prepared Exhibit 14 and will testify concerning the calculations,
Complainant’s fourth witness, Ms. Flaherty, is the Acting
Director of the 0CM Policy and Grants Division (PGD). The
The PGD is responsible for generating TSCA penalty policy
guidance for the Agency. Ms. Flaherty will describe how the
“Guidelines’ and ERPS were developed and operate.
Respectfully submitted,
Date 0 0. Silberman
orney
TOXiCS Litigation Division
Office of Enforcement and
Compliance Monitoring

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CERTIFICATION OF SERVICE
I hereby certify that the originals of the foregoing
Complainant U.S. Environmental Protection Agency’s Pre—Hearing
Exchange , and the following Exhibits , Docket No. TSCA—88—H—06,
have been filed with th Headquarters Hearing Clerk, and that
copies were hand—delivered, or sent by First Class Mail, to:
Hon. Henry B. Frazier, III
Administrative Law Judge
Office of the Administrative Law JudgeS (A—hO)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Blake L. Biles, Esq.
Jones, Day, Reavis & Pogue
1450 G Street, N.W.
Washington, D.C. 20005—2088
Date
I/i /g1
rma n
ics Litigation Division (LE—134P)
U.S. Environmental Protection Agency
40]. M Street, S.W.
Washington, D.C. 20460

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V

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C
—
MOTION TO STRIKE ?iYFIR1 T!VE DEF JSES
Complainant U.S. Environmental Protection Agency respectfully
moves, pursuant to 40 CFR S 22.16 of the Consolidatid Rules of
Practice, for an Order to strike Respondent’s Second. Third, and
Fourth Affirmative Defenses from the Respondent’s Mayer. The
grounds for striking the ‘Affirmative Defenses’ are as follows: the
Defenses (1) are insufficient as a matter of law; (2) are
immaterial, impertinent, and/or frivolous; and (3) significantly
confuse the issues in the case. In support of this Motion,
Complainant files the attached Memorandum of Points and Authorities
In su ort of Motion to Strike Affirmative Defenses , incorporated
herein by reference.
Respectfully submitted,
. ,
Dated: __________ Vincent Giordano, Esq.
Toxics Litigation Division
Office of Enforcement and Compliance
Monitoring
S..
UNITED STATES
JVIRONMENTAL PROTECTION AG CY
In the Matter of: )
)
TRDICO, INC.
INCON DIVISION )
BARBOURVILLE, XDITUCXY )
)
Respondent
)
)
Docket No. T$CA-88-H-OS

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter-of
)
)
TRDICO, INC.
)
INCON DIVISION
)
BARBOURVILLE, KENTUCKY
)
)
Respondent
)
)
Docket No. TSCA-88-N-05
• MEMORANI)UM OF PO!NTS )IND M1TM0RTT1 S TN SUPPORT
• OF MOTION TO STRIKE AFFIRP ITIVK D!F SKS
I. Introduction
Complainant U.S. Environmental Protection Agency (EPA)
respectfully moves pursuant to 40 CFR 522.16 of ths Consolidated
Rules of Practice, for an Order to strike Respondent’s Second,
Third, and Fourth Affirmative Defenses from the Respondent’s Answer.
The grounds for striking the Affirmative Defenses are as follows:
the Defenses” (1) are insufficient as a matter of law; (2) are
iiwnaterial, impertinent, and/or frivolous; and (3) sIgnificantly
confuse the issues in the case. To expedite the administration of
justice and avoid prejudice to the Complainant, the ‘Defenses
should be stricken from the Answer.
II. Statement of ha Ca e
On October 21 and 22, 1987, an authorized EPA inspector
lawfully inspected Respondent’s Barbourville . Kentucky, facility
pursuant to SectIon 11 of the Toxic Substances Control Act (TSCA).
15 U.S.C. 55 2601 g . One of the purposes of this inspection
was to review Trepico’s TSCA compliance in regards to three
particular chemical substances. These three substances were of

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—2—
particular interest because in the cover aemorandwn used by Treaco
to transmit the Premanufacture Notices (P?*Js) to EPA, Tremco stated
that ‘Tremco manufactures and uses [ these substances] as site-
limited or as industrial (compounds] . . . ., and EPA, in its
review of the P V4s, had determined that these substances were not on
the TSCA Inventory and hence, were new chemical substances. During
the October, 1987 inspection, EPA obtained from the Respondent
information which showed that Respondent had manufactured all three
substances for commercial purposes prior to submitting the P Js for
these substances, in violation of TSCA 5 5. TS A 5 5 provides that
no person may manufacture a new chemical substance unless they have
notified EPA of their intent to manufacture, at least 90 days prior
to Such manufacture. Failure to provide notice is a prohibited act
under S 15 of TSCA, for which EPA may assess a penalty under 5 16 of
TSCA.
As a followup to the inspection, EPA’S inspector requested
Information regarding the production of theses substances during the
P?.VJ review period. Tremco provided this information by letter dated
January 13. 1988. Tremco informed EPA that, in addition to
manufacturing these substances prior to submitting the P) s, Tremco
had also manufactured two of thes. three substances during their
respective Pill review periods.
On July 20. 1988, EPA filed a civil administrative Complaint
against Tremco seeking penalties for failing to properly submit PMN5
for these three substances. Counts 1 through 57 of EPA’s complaint
i]1eg that the manufacture of these substances prior to the

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—3—
submission of their respective PlflJs was in violation of TSCA and
rules promulgated thereunder. Counts 58 and 59 of EPA’S complaint
allege that the two occasions of manufacture during the P)’2J review
period also violated TSCA and rules promulgated thereunder. The
factual and legal basis for the Complaint an, fully described ifl the
Complaint, and incorporated herein by refsr•nce.
On AuguSt 16, 1988, EPA Utended the complaint as a matter of
right. The amendment was necessitated by the promulgation of a
revised TSCA S 5 Enforcement Response Policy, and resulted in a
61.6% reduction in the proposed penalty.
Respondent filed a timely Answer to EPA’s complaint. In Part
II of the Answer, Respondent set forth three Affirmative Defenses.
Complainant respectfully submits that the following defenses must be
stricken from the Answer:
“Second Defense - Tremco incorporates by reference the
admissions, averments and denials set forth above and avers that the
claims set forth in Counts 1 through 57 are barred by the applicable
statute of limitations.
Third Defense Trutco incorporates by reference the
admissions, avirments and denials set forth above and avers that the
claims set forth in Counts 1 through 59 ar. barred by the doctrines
of laches, waiver and estoppel.
Fourth Defense — Trutco incorporatss by reference the
admissions, averments and denials set forth above and avers that the
total adjusted pToposed penalty sought in the Amended Complaint is

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—4-
inconsistent with Agency policy and unreasonable in light of the
circumstances of the alleged violations.’
III. Araument
A. The ADoroDriate Leaal Standard For Strikina ‘Affirmative
Defenses’ From a ComDlaint Is To Strike ‘Defenses’ Which
Are Leoallv Insufficient. Immaterial. ImDertinent. And/or
Frivolous
The Consolidated Rules of Practice, at 40 CTR S 22.16,
authorize a party to make any written motion in an action. They do
not set forth any specific criteria governing the matter which may
appropriately be stricken from an Answer on a Motion to Strike
Affirmative Defenses. Complainant submits that the legal standards
for reviewing such a Motion under Federal Rule of Civil Procedure
12(f), 28 U.S.C. Rule 12(f), are appropriate standards for reviewing
the instant motion. This rule authorizes the Federal Courts to
strike, inter slip , any insufficient defense or any immaterial of
impertinent matter from any pleading. Z.g..
Although Motions to Strike are not always favored by the
Courts and should be granted only when the matters to be stricken
are clearly inadmissible or unrelated to the controversy. 2k MOORE’S
FEDERAL PRACTICE S 12.21 ( 2nd Sd. 1987). the recognized function
of this Motion is to ‘expedite the administration of justice ’.
American Machine & Metals. Inc. v De Bothezat I eller Co. mc . , 8
F.R.D. 306, 308 (S.D.LY. 1948). ‘Weeding out legally insufficient
defenses at an early stage’ in the proceeding can prove to be
“extremely valuable to all concerned’ - including the Court - by
vold i’g “the needless •xpend2tures of time and money’ in

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litigating issues which can be foreseen to have no bearing on the
outcome’. Narraaansett Tribe of 1ndian v. Southern Rhode Island
Land Develo ment Core. , 418 F. Supp. 798, 801 (D.LI. 1976). This
is especially true for defenses which would substantially complicate
the discovery proceedings. In such an action, a hearing is
unnecessary. U.S. V. 416.51 Acres of Land , 514 T.2d 627, 630 (7th
Cir. 1975). Indeed, the Notion to Strike is recognized as “a
useful and appropriate tool’ for weighing the legal implications to
be drawn from uncontroverted facts.’ at 631, citing 5 C. Wright
& A. Miller, FEDERAL PRACTICE AND PROCEDURE: CIVIL 51381 (1969).
Striking clearly insupportable issues or defenses, such as
those raised by the Respondent and discussed below, further supports
the administration of justice by avoiding defenses which, if
pleaded, would only serve ‘to confuse the issues’ and create the
possibility that extraneous considerations could enter into the
judicial decisionmaking process. Sun Insurance ComDanv of New York
v. Diversified Engineers. Inc. , 240 F. Supp. 606, 612 (D. Mont.
1965). Such a result could skew the proceeding in an unreasonable
and unjust direction, thereby causing significant prejudice to the
Ilovant. Thi prejudice can be exceptionally egregious where the
effect of allowing a party to prove a legally insufficient defense
at hearing would, in addition to causing confusion and unduly
lengthened proceedings, evoke undeserved sympathy for the party.
Narraaansett Tribe at 802.
A defense is insufficient as a matter of law when it would
not, un ier any facts proved In support of the allegation, constitute

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—6—
a valid defense. Sun Insurance Co . at 612. Such a defense can have
no possible bearing on the subject matter of the litigation, and
should be stricken. When the defense, at first glance, is Clearly
invalid as a matter of law, it may be characterized as ‘patently
frivolous’ and promptly stricken. Anchor Hockina COrE. V.
Jacksonville Electric Authority , 419 F. Supp. 992, 1000 (M.D. Fl.
1976). A ‘frivolous’ defense has also been d.fin.d as one that ‘can
be seen as merely pretensive, setting up some ground that cannot be
sustained by argument.’ BLACKS LAW DICTIONARY 378 (5th Ed. 1979).
An “immaterial” defense is a defense which bears ‘no essential
or important relationship to the claim for relief, Gilbert v. Eli
Lilly & Co. Inc. , 56 F.R.D. 116. 120 n.5 (D. Puerto Rico 1972), or
is simply “outside the scope of the action.’ American Sheet Metal
Inc.. v. Em-Xav Enaineerinc Co. , 478 F. Supp. 809, 815 (E.D. Ca.
1979), citing Sheppard’s ? . NUAL OF FEDERAL PRACTICE, 2nd ed. 345. An
“impertinent’ defense is any defense which is neither responsive nor
relevant to the issues involved in the action and which could not be
put in issue or be given in evidence between the parties.’ Gilbert
at 120, n.6.
In summary, litigating legally insufficient, immaterial,
impertinent, and frivolous affirmative defenses causes needless
expenditures of time and money and deflects the attention of the
parties and the court from the true issuu at hand. To avoid
confusing the issues and prejudicing the Movant, they should be
stricken from the pleading.

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—7—
3. Res ondent’s Second Defense Is Insufficient As A Matter
of Law And Should Be Stricken
Respondent’s Second Defense reads, in relevant part, as
follows: ‘Tremco . . . avers that the claims sit forth in Counts 1
through 57 are barred by the applicable statute of limitations.
The Court should strike this defense as insufficiant as a matter of
law, as there is no applicable statute of limitations that applies
to TSCA administrative enforcement actions. Further, retention of
this defense until hearing will require the parties to engage in
extensive discovery concerning when EPA knew of these violations,
and proof of this defense by Respondent would confuse the issues and
prejudice the EPA.
1. The Federal Government Is Not Sound By A Statute Of
Limitations Unless Conaress Has Clearly Manifested An
£xDlicit Intent That The Government Is So Bound .
The general rule is that the United States is not subject to
statutes of limitations in enforcing its rights unless Congress
explicitly provides otherwise. United States v. City of Palm Beach
635 F. 2d 337, 339 (5th Cir. 1981). cert. denied 454 U.S.
1081 (1981).
It is settled beyond doubt or controversy — upon the
foundation of the great principle of public policy . .
which forbids that the public interests should be
prejudiced by the negligence of the officers or agents
to whose care they are confided - that the United
States, asserting rights vested in it as a sovereign

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government, is not bound by any statute of limitations,
unless Congress has clearly manifested an intention that
it should be so bound. United States y. Nashville.
etc. Railway Com any , 118 U.S. 120 125 (1886).
[ IJt is to be observed that statutes of limitations, in the absence
of specific statutory provisions otherwise, do net run against the
Federal Governmsnt. 3-82604 28 Coap. Gin. 624, 625 (1949). It is
veil established the Congress may create a right of action without
restricting the time within which the right must be exercised.
Occidental Life Insurance Co. v. EKOC , 432 U.S. 355 (1977). In
Public Interest Research Grout of New Jersey v. United States Metals
Refining , 681 F. Supp. 237, 239 (D.N.J. 1987) the Court held that no
statute of limitations applies to enforcement actions taken under
the Clean Water Act.
In enacting TSCA and a subsequent amendment thereto, Congress
did not and has not restricted EPA’s ability to take administrative
enforcement actions by enacting a TSCA statute of limitations. See
15 U.S.C. S 2601 — 2629 and the 1986 amendment to TSCA, the Asbestos
Hazard nergency Response Act 15 U.S.C. 2641 — 2654. EPA contends
that without a statute of limitations which expressly restricts
EPA’s ability to take TSCA administrative enforcement actions, the
general rule of law applies, and this present action is not time-
barred.

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2. The A nro riate Leosi Standard for A lvina a General
Statute of Limitations )aainst the Federal Gavernment Is
That The General Statute Must Be Strictly Construed In
Favor Of The Government .
Although not expressly stated in Respondent’s Answer,
Complainant assumes that Respondent wishes to invoke a general
statute of limitations to bar this administrative •nforcement
action. Such a general provision is provided at 28 U.S.C. S 2462.
Section 2462 states ‘ [ ejxcept as otherwise provided by Act of
Congress, an action, suit or proceeding for the enforcement of any
civil fine, penalty of forfeiture, pecuniary or otherwise, shall not
be entertained unless commenced within five years from the date when
the claim first accrued ....‘
Complainant submits that the Court must strictly construe
S 2462 in favor of EPA. and such a strict construction necessitates
striking this defense from Respondent’s Answer. The Supreme Court
has pronounced the standard for the proper construction of statutes
of limitations. “‘Statutes of Limitation sought to be applied to
bar rights of the Government, must receive a strict construction in
favor of the Government..’” Badaracco at al v Commissioner of
Internal Revenue , 464 U.S. 386. 391 (1984) (quoting B. I. duPont de
Nemours & Ce. v. Davis , 264 U.S. 456, 462 (1924)). “(L)imitations
statutes barring the collection of taxes otherwise due and unpaid
are strictly construed in favor of the Government.” Lucia v United
LItL5. 474 F.24 565, 570 (5th dr. 1973).
Strict construction of 28 U.S.C. S 2462 begins with a review
of its en tment as part of the revision and codification of Title

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28. United States Code. Judiciary and Judicial Procedure 62 Stat 869
(1948). This-1948 law pertains only to the ‘Courts of the United
States’ which are defined in 28 U.S.C. S 451 as ‘the Supreme Court
of the United States, courts of appeals, district courts . . ., the
Court of Claims, the Court of Customs and Patent Appeals, the
Customs Court and any court created by Act of Congress the judges of
which are entitled to hold office during good behavior.’ Clearly,
EPA’S administrative proceeding is not encompassed by this
definition, and Complainant submits that Congress did not intend
that S 2462 apply to an EPA administrative hearing.
Congress Intended 28 U.S.C. S 2462 to apply to actions taken
in the Courts of the United States as evidenced by the texts of 28
U.S.C. SS 2461(a) and 1355. In S 2461(a) Congress authorized the
Federal Government to take a civil action to recover or enforce a
civil fine whenever the mode of recovery had not been prescribed.
In S 1355 Congress provided jurisdiction for these actions - “the
district courts shall have original jurisdiction . . . for the
recovery or enforcement of any fine . . . incurred under any Act of
Congress.’ at 934. EPA’s position is that Congress, in turn,
provided in 5 2462 a statute of limitations to apply to those
actions, which it had, in this law, prescribed both a mode and a
jurisdiction for recovery. Thus, while, the Respondent would prefer
that the Court look only to S 2462 of the Statute, the Court must
look at the statute as a whole.

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A strict, and accurate construction of 5 2462 indIcates that
5 2462 applIes to civil judicial enforcement actions which seek to
enforce a penalty In the U.S. District Courts, and not to
administrative enforcement actions which seek to aas•is an
administrative penalty. Chief Administrative Law Judge Harwood
analyzed this issue similarly in the Memorandum and Order in In the
Matter of Union Carbide , Docket No. TSCA-85-M-02 (October 3, 1985).
In this case Judge Harwood stated ‘(tjhe question izvnediately raised
Is the validity of Union Carbide’s assumption that 28 U.S.C. 2462,
applies to the institution of proceeding on an administrative
complaint before an agency, as distinguished from a court proceeding
to assess a penalty or to enforce an administratively imposed
penalty. Since Title 28 applies to proceedings in the United States
courts, it would seem that it would not. at 6.
Bolstering Judge Harvood’s view are those decisions which
determine the point in time that a claim first accrues under 5 2462
or the other general statutes of limitations provided in Title 28.
The United States Supreme Court addressed this issue in Cro m Coat
rz.wit Co. V. United States , 386 U.S. 503 (1967). In this case, the
Plaintiff had brought suit against the Federal Government in U.S.
District Court more than six years after completing the performance
of a contract. The United States claimed that the suit was time-
barred by the g•neral six year statute of limitations provision
S 2401(a). The Court held that the claim was not time-barred
because the underlying claim did not accrue until the completion of
the adjii nistratIve proceedings. 1 . . at 511. The Court went on to

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—12—
say that ‘the ‘right of action’ of which S2401(a) speaks is not the
right to administrative action but the right to file a civil action
In the courts against the United States.’ J .
This same line of reasoning was followed by the Seventh
Circuit in U.S. DeDartment of Labor V. Old Ben Coal Com anv , 676
F.2d 259 (1982). In this case, Old Ben had violated the Federal
Coal Nine Health and Safety Act in 1973 and had raised S 2462’s as a
defense to the Federal Government’s enforcement proc•eding. In
1974, the Department of Interior sought to assess civil penalties
against Old Ben for the sixteen 1973 violations of the Coal Act.
The administrative law judge issued a decision in favor of the
Government on June 23. 1975 which became final on July 23. 1975.
Old Ben failed to pay the assessed penalties and the United States
sued on July 18, 1980 in U.S. District Court to enforce the July 23.
1975 order. The court held that in the context of the Coal Act
the district court claim accrues only after the
administrative proceeding has ended, a penalty has been
assessed, and the violator has failed to pay the
penalty. The Coal Act states specifically that the
Secrstary shall file a petition for enforcement of the
order asssuing the civil penalty only if the person
against whoa the penalty was assessed falls to pay it
within th. time prescribed in the order. . .
Obviously, an administrative agency order must exist
before the Secretary can file a district court action to
enforce It. Therefore, if 28 U.S.C. S 2462 applies to

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the district court proceeding the limitations period
begins tO run when the administrative order becomes
final. at 261.
Important to note at this point, is that Congress set up the
same type of enforcement mechanism in TSCA. Section 16 of TSCA
provides that penalties are to be assessed by the Administrator by
an order made on the record after opportunity for a hearing, and if
any person fails to pay an assessed civil penalty, the Attorney
General shall recover the amount assessed in an action brought In an
appropriate United States District Court.
The First Circuit court apparently found the rational of Crown
Coat and Old Ben meritorious. In United States v. Mever 808 F 26
912. 916 (1st Cir. 1987) the Court noted that “the use of the word
‘enforcement’ in 28 U.S.C. 5 2462 is not without significance; the
noun by definition . . . presupposes the existence of an actual
penalty to be enforced. The Court went on to say that ‘(o]utside
of the Fifth Circuit, no court has ever held that, in a case where
an antecedent administrative judgment is a statutory prerequisite to
the maintenance of a civil enforcement action, the limitations
period on $ recovery suit runs from the date of the underlying
violation as opposed to the date on which the penalty was
administratively imposed. . at 916.
Other Courts hays strictly construed the extent of 5 2462’s
applicability, and have reached the same conclusion - 5 2462 does
not apply to bar Federal Government claims to assess penalties.
These Coerts, however, addressed the issue of what type of penalty

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—14—
is encompassed by 5 2462, rather than addressing the issue of
applicability in terms of when a claim accrues. In United Stat.
207 F.2d 796, 798 (5th dr. 1953) the Federal Government
sought to recover from the defendants $10 .000, $2,000 for •ach of
f lvi separate fraudulent acts. The defendants raised S 2462 as a
defense and the Court held that the action was not a criminal
prosecution, nor a civil action for a penalty, it was, however, a
civil sanction to recover an award of damages of a compensatory
nature. 1 See also United States v. Schneider , 139 F. Supp. 826.
828 (S.D.N.Y 1956) 9tjhe availability of S 2462 as a defense turns
upon whether . . . the Surplus Property Act . . . imposes a civil
penalty or a civil sanction of a remedial character.
This was the line of reasoning chosen by EPA Administrative
Law Judge Jones, in the Matter of 3.V . Peters and eom nv , RCRA
Docket Number V-W-8l—R-75 (Initial Decision 1988). In 3.V. Peters ,
the Federal Government sought to assess a $25,000 penalty in
November of 1987 for violations uncovered in December of 1980.2 The
respondent raised 5 2462 as a defense and Judge 1 jones held that
S 2462 does not apply to a Resource Conservation and Recovery Act
1 Important to note is that the Court in recognized;
the general rule that statutes of limitations do not ordinarily run
against the United States, that S 2462 is an exception to the
general rule and is in derogation of an inherent attribute of
sovereign i unity. United States v. Weaver , 207 F.2d 796, 798 (5th
Cir. 1953)
2 S 3008(g) of RCRA states ‘(amy person who violates any
requirement of this subchapter shall be liable to the United States
for a civil penalty in an amount not to exceed $25,000 for each such
uio]ation. Each dRy of such violation shall, for purposes of this
subsection, constitute a separate violation.’

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(RCRA) enforcement action. He held that a RCRA enforcement action
Bought ‘a civil administrative sanction, regulatory in nature and
remedial in charact•r, and is not considered penal in any sense, but
assessed for the Bole purpose of achieving compliance with the Act.’
I d. at 9. Complainant submits that there is no significant
difference between the language of 53008(g) of RCRA and 516(a), 3 nor
in Congriss’ intent in enacting these administrative sanctions.
Therefore. Complainant argues that the rationale used by the Court
in 3.V. Peters applies directly to this case, and as such requires
the Court to strike Respondent’s statute of limitations defense.
Assuming arauendo that 28 U.S.C. 5 2462 applies to TSCA
administrative enforcement actions. EPA argues that the five years
begins to run at. the time EPA became aware of the violations. EPA
maintains that Respondent’s violations where continuing violations
which were corrected by the filing of P? Is for each of these
substances on July 21, 1983. On this date EPA became aware of the
violative acts alleged in Counts 1 through 57, and therefore, the
Complaint, filed on July 20. 1988. was filed within the five year
limitations period. In United States v. Advance Nachinerv Co . • 547
F. supp. loss (D. Minn. 1982), the Court found that a failure to
report information under the Occupational Safety and Health fAct was
a continuing violation after finding that th. consequences of a
failure to report health and safety information had potential direct
3. Section 16(a) of TSCA states ‘ [ amy person who violates a
provision of section 15 shall be liable to the United States for a
‘ lvi i pQna]ty in an amount not to exceed $25,000 for each such
violation. Each day such a violation continues shall, for purposes
of this subsection, constitute a separate violation of section 15.’

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—16—
and continuing public consequences. The court noted that the
reporting requirements would be frustrated if a manufactur•r could
successfully hide evidence of a product defect for five years. 547
F. Supp. at 1090. Advance Machinery’s holding is applicable to the
continuing risk assessment program set up by in Congress in TSCA.
and EPA in 40 C.F.R. Part 720.
In enacting TScA, congress intended to provide protection
against unreasonable risks associated with the chemicals that have
been, and those that may be, introduced into co erc•.
This vast volume of chemicals have, for the st part,
been released into the environment with little or no
knowledge of their long term health and environmental
effects. As a result, chemicals currently in coivinercial
and household use are now being found to cause or
contribute to health or environmental hazards unknown at
the time commercial use of the chemicals began. Leg
Hist. at 411 (House Report at 3). gg aJag Leg. Mist.
at 159 - 161 (Senate Report at 3—5).
It is imperative, therefore, that the integrity of Congress’s
Premanufacturs Review Strategy not be undermined by the ability of a
person to hids a violation for a period of mon than five years.
The Court in Uniøn Carbide , i u. followed the rationale of
Advance Machinery . Although Judge )Iarvood stated that he believed
S 2462 did not apply to a TSCA administrative proceeding. he vent on
to find that EPA was not barred in any event, because the complaint
ha. been I iJed within five years from the date that EPA knew of the

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—17—
violation. In Union Carbide , the violation occurred in 1977, it
became known to EPA in September of 1983, and EPA fil•d a complaint
against Union Carbide in Sptember of 1985.
Although a decision that S 2462 appliss to this case, and
begins to run at the time EPA knew of the violations, is not
dispositive of this Motion to Strike, it would significantly narrow
the statute of limitations issues, and would provide t.hs rationale
for the parties to seek extensive discovery regarding when EPA had
knowledge of these violations.
C. ResDondent’s Third Defense Is Frivolous nd Insufficient
Ac A Matter of Lew nd Should 5 Stricken
Respondent’s Third Defense reads, in relevant part, as
follows: ‘Tremco . . . avers that the claims set forth in Counts 1
through 59 are barred by th• doctrines of laches, waiver and
estoppel .
It is a well settled principle of law that the doctrine of
laches is no bar to a suit brought by the government to vindicate a
public right . . . Cou ionwealth of Massachusetts v. Russell Stayer
Cafl iM. 541 P. Supp. 143, 144 (D. Mass. 1982). ‘Laches is not a
defense to an action filed within the applicable statute of
limitations nor is It available against ths United States.’ US. v.
Richard RePass , 688 F.2d 154, 158 (2nd Cir. 1982).
Barring a showing of affirmative misconduct by the federal
government, the doctrine of estoppel cannot be invoked against it
and the United States is not subject to defense of laches in

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—18—
enforcing its rights. U.S. V. Ruby Co , 588 F.2d 697. 705 n. 10,
cart denied, 422 U.S. 917 (1978).
Complainant is seeking to enforce a public right and to
protect the public’s interest through the enforcement of the
environmental laws and regulations at issue in this case. There are
two criteria for dismissal for laches: unreasonable delay in
bringing, the suit and prejudice to the defendant caused by such
delay. Baylor University Medical Center v. Heehler , 758 T.2d 1052,
1054 (5th dr. 1985). Carlson TV v. City of Marble , 612 F.Supp.
669, 672 (D.Ninn. 1985). Elements of ladies are full knowledge of
the facts, unreasonable delay in assertion of available remedy, and
intervening reliance by and prejudice to another. Thaco Coro. v
Hodel , 611 F.Supp. 1130, 1208 (D.Colo. 1985).
EPA’s Office of Toxic Substances had reason to know that.
Tremco had violated TSCA on July 21. 1983. the date they received
the cover memorandum which transmitted the three subject P? s.
Complainant, however, did not become aware of this cover memo until
late summer 1987. after an EPA inspector had randomly selected these
PuNs for review, inspection, and validation. During the October
1987 inspection, the inspector was able to verify the existence of
TSCA violations dating back to 1979. EPA concluded its
investigation in the spring of 1988, after it had completed its
discussions with Tremco and its receipt of the January 13, 1988,
followup letter from Tremco, which provided the evidence to support
the last two Counts of this Complaint. Complainant filed against
Tremco le? s than six months after the inspection and followup had

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—19—
been completed, and believes that EPA did not unreasonably delay
taking this action.
Furthermore • Respondent has not demonstrated that it has been
prejudiced as a result of Complainant’s filing on July 20, 1988.
9here are two (2) types of prejudice that will support a claim of
lathes: (1) loss of evidence which would support defendant’s
position and (2) change of position in a way that would not have
occurred but for the delay. Rick v. Class , 643 S.W.2d 872. 877
(Mo.Ct. App. 1982). In this present action the Respondent has not
been prejudiced by any possible delay. Respondent a iits in its
Answer that they manufactured all three chemicals during the, time
period alleged in the Complaint, and was able to provide in their
answer more complete information regarding the violative production.
thereby increasing the number of violative acts. Clearly, the
Respondent has not loss any evidence regarding their manufacture of
these chemicals. Clearly, under these facts, this Third Defense
cannot survive. Accordingly. Respondent’s Third Defense should be
stricken as frivolous and insufficient as a matter of law.
D. R.g ondent’a fourth Defense Is Frivolous And Confuses The
Issues In This Case And Should Ia Stricken
Respondent’s Fourth Defense reads, in relevant part, as
follows: ‘Tremco . . . avers that the total adjusted proposed
penalty . . . is inconsistent with Agency policy and unreasonable in
light, of the clrcumstRnces . . .

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—20-
Section 16 of TSCPI authorizes the Administrator of EPA to
assess civil penalties for violations of TSCA. In September of
1980. EPA developed and published guidance in th Federal Register
for the assessment of civil penalties for violations of TScA. 45
Fed. Req. 59770 (1980). Further in August of 1988, EP revised its
TSCA S 5 penalty policy to, among other things, more completely
incorporate the risk of hazard to human health and the environment
as a distinguishing factor among violations. Clearly, the
Respondent benefited from a revised penalty policy, for the proposed
penalty in this action was reduced by 61.6% under the August 1988
policy.
The proposed civil penalties are determined in two stages: 1)
through the determination of the gravity based penalty; and 2)
through adjustments to the gravity based penalty. The gravity based
penalty is calculated based upon the nature, extent and
circumstances of the violation. Upward and downward adjustments to
the gravity based penalty are made upon consideration of
culpability, history of violations, ability to pay, ability to
continue in business and such other matters as justice may require.
Complainant asserts that the civil penalty ass.ssed in the
instant matter was calculated pursuant to Agency guidance. The
gravity based penalty was based on the number and sizes of batch
production information provided by the Respondent, was further
adjusted for Respondent’s July 21, 1983, voluntary disclosure of the
violations incorporated in Counts I through 57, and finally for the

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—21—
non-disclosed violations alleged in Counts 58 and 59, was adjusted
upward for past history of violations.
Tar these r.asons , Respondent’s Fourth Defense must be
stricken from the Mswer as it is frivolous and it significantly
confuses the issues in this case.
IV. CON LUSION
For the aforesaid reasons, Mi iraative Defenses 2. 3, and 4
should be stricken from Respondent’s Answer.
Respectfully submitted,
Dated : / &f/ ’f/”
1 Toxics Litigation Division
Off ice of Enforcement and Compliance
Mont taring

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UNITED STATES
JVIRONMU TAL PROTECTION AG JCY
ORDER
By Motion dated October 24, 1988, Complainant U.S.
Environmental Protection Agency (EPA) moves for an Order to
strike Affirmative Defenses 2, 3, and 4 from the Respondent’s
Answer as immaterial, impertinent, frivolous, and/or
insufficient as a matter of law. The Court being fully advised,
It is
ORDERED that the following matter be and is hereby
stricken from the Answer:
“Second Defense - Treinco incorporates by reference the
admissions, avennents and denials set forth above and avers that
the claims set forth in Counts I through 57 ar• barred by the
appllcabl• statute of limitations.
Thir(. Defense Trenco incorporates by reference the
admissions, averments and denials set forth above and avers that
the claims set forth in Counts 1 through 59 are barred by the
doctrines of laches, waiver and estoppel.
In the Matter of:
)
)
TRDICO, INC.
)
INCON DIVISION
)
BMBOURVILLE, X TUCXY
)
)
Respondent
)
)
Docket No. TSCA-88-H-O5

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—2—
Fourth Dsfens• — Treaco incorporates by reference the
admissions averments and denials set forth above and avers that
the total adjusted proposed penalty sought in the Amended
Complaint is inconsistent with Agency policy and unreasonable in
light of the circumstancss of tfls alleged violationa.
Frank W. Vanderheyden
Administrative Law Judge
Dated: _______________

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C T1T1C T fl? S V1
I hereby Certify that the original of the foregoing Motion To
Strike Affiraative Defenses and Neaorandia of Points and authorities
In Support of Motion To Strike Affiraative Defenses and Order,
Docket No. TSCA S$-H-OS, have been filed with Headquarters Hearing
Clerk, and that copies were sent, registered ash, return receipt
• or hand-delivered tez
Honorable TraM V. Vanderbeyden
Administrative Law Judge
Office of the Administrative Law Judges (A-hO)
U.S. Environmental Protection Agency
401 N Street, S.W.
Washington, D.C. 20460
Stephen Q. Giblin
Jones, Day. Reavis & Pogue
North Point
901 Lakeside Avenue
Cleveland, Ohio 44114
Respectfully submitted,
/ . I C ’
Dated: / Vincent Giordano, Esq.
Toxics Litigation Division
Office of Enforcement and Compliance
Monitoring

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w

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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
0,,
CONSENT AGREEMENT
The United States Environmental Protection Agency (“EPA” or
“the Agency”)- as Complainant, and Grifftex Chemicals, (“Grifftex”
or “the Company”) as Respondent, the Parties herein, having
consented to the entry of this Consent Agreement and Final Order
before the taking of any testimony and without any adjudication
of any issues of law or fact herein, agree to comply with the
terms of this Consent Agreement and the attached Final Order.
I. PRELIMINARY STATEMENT
A. EPA initiated this proceeding for the assessment of a
civil penalty pursuant to Section 16(a) of the Toxic Substances
Control Act ( “TSCA” or “the Act” - 15 U.S.C. §2601 et ‘) by
issuing an administrative Complaint arid Notice of Opportunity for
Heax ing (“Complaint), dated and served upon Grifftex on May 25,
1988. The Complaint, incorporated herein by reference, states
that Complainant has reason to believe that Grifftex failed to
submit a timely notice of commencement (“NOC”) to the EPA on, or
)
In the
Matter of:
-
)
)
)
GRIFFTEX
CHEMICALS,
.
Respondent
)
)
)
)
)
Docket No. TSCA 88-H—03
CONSENT AGREEMENT AND
FINAL ORDER
000001

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no later than 30 calendar days after, the first date of manufacture
of a new chemical substance, in violation of TSCA Sections 5 and
15, 15 U.S.C. H2604 and 2614, respectively.
B. For purposes of this proceeding, without trial or other
actual litigation of the issues or any adjudication of the facts,
and in order to avoid disruption of orderly business activity and
the expense of protracted and costly litigation, Grifftex
(1) admits that EPA has jurisdiction over the subject matter
alleged in the Complaint; (2) neither admits nor denies the
findings of fact contained in the Complaint and this Consent
Agreement; and (3) consents to the terms of this Consent Agreement
and Final Order.
C. EPA agrees to mitigate the civil penalty assessment, set
forth in the Complaint, as described below.
0. The terms of this Consent Agreement and Final Order con-
stitute a full settlement of the civil administrative action.
E. Grifftex now waives its right to request a judicial or
administrative hearing on any issue of law or fact set forth in
the Complaint, including but not limited to its right under
Section 16(a)(2)(A) of TSCA to request a hearing.
F. Grtfftex certifies that, with respect to the violations
alleged in this proceeding, the facility subject to this civil
administrative action is now in full, compliance with the NOC
requirements in 40 CFR §720.120.
000002

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—3—
II. EPA FINDINGS OF FACT
A. Paragraphs 1—7 of the Complaint are incorporated herein
by referenceas findings of fact in this matter.
B. Based upon inspection of Respondent’s records, and
on review 01 information provided by Respondent subsequent to the
filing of the Complaint, EPA has determined that the first commercial
batch of Chemical A was manufactured on September 12. 1984,
1.2 days after the MOC was submitted to EPA.
III. EPA CONCLUSIONS OF LAW
The conduct described in Paragraph II. above, consisting of
Grifftex’s failure to comply with the NOC requirements in 40 CFR
720.102, constitutes a violation of TSCA Sections 5 and 15(1)(C)
for which a penalty may be assessed pursuant to TSCA Section 16(a).
IV. CIVIL PENALTY
A. Pursuant to EPA’S TSCA Section 5 Civil Penalty Policy,
the Agency proposed in it. Complaint in this case a $10,000 civil
penalty.
B. Subsequent to the filing of the Complaint, EPA amended
its TSCA Section 5 Civil Penalty Policy. In accordance with the
amended Policy. bscause Respondent submitted its HOC Less than 30
days prior to manufacture, the Agency has reduced its initial
penalty assessment to $2,000.
C. For purpose. of settlement, EPA has reduced the civil
penalty in this case by an additional 40% to 51,200. The 40%
000003

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—4-
reduction includes; (1) a 15% reduction to reflect the cooperation
and good faith shown by Grifftex in abating the violations all.eg
in the Complaint and negotiating this Consent Agreement and
(2) a 25% reduction to reflect the agreement by Grifftex in
Paragraph V.B. of this Consent Agreement to undertake specific
steps to ensure that all future NOCs are submitted in a timely
manner.
V. TERMS OF SETTLEMENT
A. Grifftex agrees to the payment of a civil penalty in the
sum of $1,200. Grifftex shall pay the civil penalty by forwarding
a cashier’s or certified check within 30 days of the issuance
of the Final Order, payable to the Treasurer of the United States
of America in the amount of 51.200, to:
U.S. Environmental Protection Agency
Hearing Clerk
P.O. Lock Box 360277M
Pittsburgh, PA 15251
In addition, Grifftex shall forward a copy of the check to EPA to
ensure a record of compliance with this Paragraph V.A.
B. Grifftex agrees to provide notice in writing within
30 days of the issuance of the Final Order, to all personnel
responsible for preparing and submitting NOCs, of the requirements
in 40 CFR 720.102 for timely submission of NOCs. Such notice
shall include an instruction to submit the NOCs only after
the substances subject to the NOCe have actually been produced
for non-exempt commercial purposes. In addition. Grifftex shall
forward a copy of the notice to EPA to ensure a record of compliance
with this Parapgraph V.B.

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C. If Grifftex fails to pay the civil penalty in a timely
manner as described in Paragraph V.A., or inform its personnel
of the requirements for submission of timely NOCs and notify
EPA thereof a described in Paragraph V.8., Grifftex shall include
a stipulated penalty of $100 per calendar day, up to a total of
$2,000. with the payment described in paragraph V.A., unless
EPA in writing excuses or mitigates the stipulated penalty.
D. The copies of the cashier’s or certified check and the
written notice required to be transmitted to EPA pusuant to
Paragraphs V.A. and V.B., respectively, shall be provided to the
following person:
Mr. Tony Ellis
Case Development Officer
United States Environmental Protection Agency
Office of Compliance Monitoring
Case Support Branch (EN—342)
401 N Street, S.W.
Washington, D.C. 20460
VI. OTHER MATTERS
A. Nothing in this Consent Agreement and Final Order shall
relieve Grifftex of the duty to comply with all applicable
provisions of TSCA and other environmental laws.
B. This Consent Agreement shall be binding on all Parties to
this action, their officers, directors, employees, successors, and
assigns. Th. undersigned representative of each Party to this
Consent Agreement certifies that he or she is fully authorized by
the Party whom he or she represents to enter into the terms and
bind that Party to it.
o ô GO4

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—6—
C. This Consent Agreement shall be binding upon the Parties
and in full effect upon execution of the Final Order by the Adinini
strator of EPA or his designated representative.
D. Grifftex’s obligations under this Consent Agreement shall
end when Grifftex has performed all of the terms of the Consent
Agreement in accordance with the Final Order in this matter.
E. Failure to pay the civil penalty in a timely manner
pursuant to Paragraph V.A. may result in the forwarding of this
action to the United States Department of Justice for collection
of the amount due plus interest and stipulated penalties.
000006

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—7-.
FOR COMPLAINANT:
FOR RESPONDENT:
Grifftex Chemicals
Opelika, Alabama
JON D SILBERMAN, Attorney
Tox s Litigation Division
Of fice of Enforcement and
Compliance Monitoring
U.S. Environmsntal Protection
Agency
Date:
Q /i /fg
*connie Musgrove, Chief Executive Officer (CEO) , of the Office of
Compliance Monitoring, has redelegated the authority of the CEO
to sign documents requiring the Compliance Division Director’s
signature.
*
EN SHI dISHI. Direct
Compliance Division
Office of Compliance Monitoring
Of f ice of Pesticides and Toxic
Substances
U.S. Environmental Protection
Agency
Date:
BY % A1 & Q
General Manager
Date:
cC L z :;Y. .
FREDERICK F. STIEHL ‘
Associate Enforcement Counsel for
Pesticides and Toxic Substances
Office of Enforcement and
Compliance Monitoring
U.S. Environmental Protection
Agency
Date:
Appr6 d ip legal form
By:
H. L. OODRI
Associate Legal. Counsel
West Point Pepperell
P.O. Box 71
West Point, Georgia 31833
Date: September 12, 1988
I (
000007

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I
)
In the M
atter of:
)
)
)
GRIFFTEX
CHEMICALS,
Respondent
)
)
)
)
)
I ,
Docket No. TSCA 88-H-03
FINAL ORDER
FINAL ORDER
Pursuant to Section 16(a)(2)(C) of the Toxic Substances
Control Act (“TSCA” or “the Act” - 15 U.S.C. c2601 et eq).
15 U.S.C. 2615(a)(2)(C) , upon consideration of the foregoing
Consent Agreement, the factors expressed in TSCA Section 16(a)(2)
(B). 15 U.S.C. §2615(a)(2)(B), and the good faith and efforts
exhibited by Respondent 1 it is hereby ORDERED:
1. Respondent Grifftex Chemicals shall comply with all of
the terms of the Consent Agreement, incorporated herein by reference,
and with the requirements set forth in TSCA and regulations
promulgated thereund.r;
2. Respondent is assessed a civil penalty in the sum of
One Thousand, Two Hundred Dollars ($1,200.00);
000008
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
-
P C ,.
‘0 ,

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—2—
3. Respondent shall, within thirty (30) calendar days of
receipt of this signed Consent Agreement and Final Order. forward
a cashier’s or certified check, payable to the Treasurer of the
United States of America, in the amount of $1,200. to. U.S.
Environmental Protection Agency; Hearing Clerk: P.O. Lock Box
360277M; Pittsburgh. PA 15251, as described in the Consent
Agreement.
4. Respondent shall provide written notice to its personnel
of the notice of conunencement requirements in accordance with
the terms of the Consent Agreement.
Date: _______ __________
RONALD L. Mc LUM
Chief Judicial Officer
U.S. Environmental Protection
Agency
000009

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CERTIFICATE OF SERVICE
I do hereby certify that the foregoing “Consent Agreement and
Final Order”, Docket No. TSCA-88-H-03, was filed with the Hearing Clerk
and true and exact copies of the same were sent by Certified Mall, postage
prepaid to respondent and by Interoff Ice to the complainant as listed
below:
H.L. Goodrich, Esq.
Associate Legal Counsel
West Point Pepperell
P.O. Box 71
West Point, GA 31833
Jon D. Silberinan, Esq.
Toxics Litigation Division (LE—134P)
Office of Enforcement and Compliance Monitoring
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Dated: October 5, 1988
U.S. Environmental Protection Agency
401 14 Street, S.W.
Washington, D.C. 20460
000010

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BEFORE THE ADMINISTRATOR
U.S. ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C.
In
the Matter
of:
)
The
McCloskey Corporatic-n
Respondent
)
)
)
CONSENT ORDER
Pursuant to the terms of the attached Consent Agreement
between the United States Environmental Protection Agency, as
Complainant, and The McC .osk y Corporation, Philadelphia,
Pennsylvania (“McCloskey” , as Respondent, which agreement is
incorporated by refere!ce into this Consent Order,
IT IS NOW, THEREFORE, ORDERED THAT:
1. McCloskey shall comply with all terms of the
Consent Agreement.
2. A civil penalty of $615,650.00 shall be paid by
McCloskey.
3. McCloskey shall, within sixty (60) calendar days
of its receipt of this Order, forward a certified or cashier’s
check, payable to the order of the “Treasurer of the United
States of America,” in the amount of $615,650.00, to:
U.S. EPA — Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251
Docket No. TSCA-89-H-04
000011

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2
4. Failure to remit the civil penalty in accordance
with this order will constitute a breach of this order and will
cause McCloskey to become subject to the stipulated penalty of
one hundred dollars er diem immediately plus interest as allowed
by law, and without further proceedings.
Dated: MAR - -
Ronald L. McCallum
Chief Judicial Officer
U.S. E,vironmental Protection
Agen y
Washington, DC 20460
000012

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
IN THE MATTER OF ) DOCKET NO. TSCA 89-H-04
)
THE MCCLOSKEY CORP.
PHILADELPHIA, PENNSYLVANIA )
)
RESPONDENT )
CONSENT AGREEMENT
The United States Environmental Protection Agency (“EPA” or
“the Agency”) as Complainant, and The McCloskey Corp.,
Philadelphia, Pennsylvania (“McCloskey”) as Respondent, the
Parties herein, wishing to settle all matters pertaining to this
case and having •;on nted to the entry of this Consent Agreement
3nd Consent Orde .
NOW, THEREFORE, before the taking of any testimony, without
any adjudication of any issues of law or fact herein, and
without admission of violation of law or regulation by
McCloskey, the Parties agree to comply with the terms of this
Consent Agreement and the attached Consent Order.
I. PRELIMINARY STATEMENT
EPA initiated this proceeding for the assessment of a civil
penalty pursuant to Section 15 of the Toxic Substances Control
Act (“TSCA”, 15 U.S.C. § 2601 g.) by issuing an
administrative Complaint and Notice of Opportunity for Hearing,
dated and served upon Respondent on February 16, 1989.

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—2—
A. The Complaint stated that Complainant has reason to
believe that McCloskey violated TSCA § 5(a)(l), 15 U.S.C.
§ 2604(a)(l), by manufacturing twenty-six chemical substances
(because the name of the cherticals were submitted as
confidential business information, the chemicals which are the
subject of this proceec.ing are hereinafter designated as
Chemicals 1 through 26) prior to submitting a premanufacture
notification; TSCA § 15(l)(B) by manufacturing twenty-six
chemical substances which di f not appear on the list of chemical
substances maintained by thc Administrator pursuant to TSCA § 8,
15 U.S.C. § 2607; and T;CA § 15(3)(B) by failing to submit
reports required by TS A prior to the manufacture of these
substances.
B. This Consent Agreement and Consent Order shall be a
complete settlement of all civil and administrative claims and
causes of action which arose or could have arisen under TSCA in
connection with the production of Chemicals 1 through 26 by
McCloskey.
C. McCloskey certifies that it has filed a premanufacture
notice with EPA for Chemicals 1 through 26 and that the notice
review period has expired.
D. For purposes of this proceeding, without trial or other
litigation or admission of the issues or any adjudication or
admission of the facts, McCloskey admits that EPA has
jurisdiction over the subject matters alleged in the Complaint.
t. 4

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—3—
E. McCloskey now waives its right to request a judicial
or administrative hearing on any issue of law or fact set forth
in the Complaint, including but not limited to its right under
TSCA § l6(a)(2)(A) to request a hearing.
U. EPA ALLELATIQNS OF FACT
On August 21, 1987, Respcndent provided information to
EPA which indicated that Respondent had manufactured Chemicals
1 through 26 on multiple occasions prior to the date these
chemicals appeared on the TSCA Inventory of Existing Chemical
Substances maintained by the AdmLnis rator pursuant to TSCA § 8,
15 U.S.C. § 2607. As a result r.f receiving this information
from McCloskey and of reviewin] Respondent’s records, EPA
alleged in its Complaint that t4cClbs]cey violated the provisions
of TSCA inasmuch as Respondent:
1. violated TSCA § 5(a)(1), 15 U.S.C. § 2604(a)(1), which
states that no person may manufacture a new chemical substance
without submitting a notice to the Administrator of EPA at least
ninety (90) days before manufacturing such substance;
2. violated TSCA § 15(1)(B), 15 U.S.C. § 2614(1)(B), which
states that it is unlawful for any person to fail to comply with
any require ont prescribed by TSCA § 5; and
3. violated TSCA § 15(3)(B), 15 U.S.C. § 2614(3)(B), which
states that it is unlawful for any person to fail to submit
reports required by TSCA.
0 ‘0O;15

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—4—
III. EPA ALLEGATIONS OF LAW
EPA alleged in its complaint that the conduct described in
Section II above constituted violations of TSCA § 5(a)(l),
15(l)(B), and 15(3)(B), f or which a civil penalty may be
assessed against McCloskey.
IV. CIVIL PENALTY
Pursuant to TSCA § 16(a), the EPA TSCA § 5 civil penalty
policy, and based upon the facts alleged in the Complaint, EPA
proposed a gravity-based civil penalty of $2 .706,000. Because
McCloskey voluntarily disclosed to EPA t; e violations alleged in
the Complaint, the proposed penalty wa jt sted downward
twenty-five percent for these violatio,s. Further, since
McCloskey’s disclosure was conducted in a timely fashion, the
proposed penalty was adjusted downward an additional twenty—
five percent. The final adjusted proposed penalty provided in
the complaint was $1,353,000.
EPA further reduced the penalty by fifteen percent after
McCloskey provided EPA with infor ation which documents that
McCloskey took all steps reasonably expected to mitigate the
violations, once McCloskey discovered these violations during
an internal audit of company records. Finally, in consideration
of the Environmentally Beneficial Expenditures which McCloskey
has made and ias agreed to make, EPA is exercising its
discretion under the penalty policy and has adjusted the
proposed civil penalty downward an additional twelve percent.
000016

-------
—5—
Therefore, EPA has adjusted the proposed civil penalty downward
by seventy seven percent. These downward adjustments result in
a final adjusted civil penalty of $615,650.
V. TERMS OF SETTLEMENT
In order to ensure future compliance with •.he Toxic
Substances Control Act, the following actions have been and/or
will be taken by McCloskey.
A. Environmental Audit
McCloskey Corporation represents and certifies that it has
spent approximately $400,000 to conduct an exten3ive internal
audit of the TSCA compliance status of its threc manufacturing
facilities and corporate headquarters. These eozts include
laboratory analyses of McCloskey’s raw chemical substances and
final products, and the expenditures of corporate management
resources to fully investigate TSCA compliance issues. The
audit was completed in August, 1987, and identified a list of
26 chemical substances which were either not on the Public TSCA
Inventory or for which McCloskey PMN documentation could not be
found. It is this Audit which led to the Company’s prompt
disclosure to EPA that a potential TSCA compliance problem
existed.
B. TSCA Com 1iance Plan
McCloskey has developed a corporate TSCA Compliance Plan
for the manufacture and distribution in commerce of chemical
substances. McC-loskey represents and certifies that it has
spent approximately $364,000 to prepare and implement this
000017

-------
—6—
compliance plan. Expenditures include: developing a computer
program which will allow McCloskey to integrate all batch
creation and sales activities in a manner that will preclude the
manufacture of a chemical substance which is not on the TSCA
Inventory, and fees to outside consultants for their ad’ ice and
counsel in addressing TSCA compliance concerns and formUating
this compliance program.
C. Publications in Trade Journals
McCloskey will submit an article on TSCA compliance to
three separate trade journals for the paint and coatings
industry. The article will be authored or co-authored b Mr.
Robert Katherine, Chairman of The McCloskey Corporatior..
McC].oskey will submit to EPA, for its review and comment, no
later than 60 days after the effective date of the Consent
Order, a draft of the article to be published in these trade
journals, and a list of the trade journals. Upon completion of
EPA’S review, McCloskey will submit the article for publication
no later than 30 days after EPA has returned the article to
McCloskey. Within 30 days following publication of the article,
McCloskey will submit a copy of the published article to EPA.
D. EP A Compliance Seminar for Customers
McCloskey Corporation will conduct a compliance seminar for
its customers on the statutory and regulatory responsibilities
of users and processors of chemicals subject to Section 313 of
the Emergency Planning and Community Right-to-Know Act of 1986
(EPCRA). McCloskey will complete this compliance seminar on
000018

-------
—7—
EPCRA § 313 no later than 180 days after the effective date of
the Consent Order in this matter. McCloskey will submit to EPA,
for its review and comment, a detailed agenda for the upcoming
seminar no later than 60 days following the effective date of
the Consent Order in this matter. No later than 30 days
following completion of this seminar, McCloskey will certify to
EPA the completion of this seminar.
E. Notice
All reports and submissions required to be made to EPA by
McCloskey under paragraphs C & D above shall be sent to:
U.S. Environmental Protection Agency
John Foley (EN-342)
401 M. Street S.W.
Washington, D.C. 20460
F. Civil Penalty
In consideration of the aforementioned Terms of Settlement,
the Parties agree to a settlement consisting of the payment of
a civil penalty in the amount of $615,650. Payment is to be
made by McCloskey by mailing a certified or cashier’s check
within sixty (60) days of its receipt of the executed Consent
Order, made payable to the “Treasurer of the United States of
America” to:
U.S. Environmental Protection Agency
Hearing Clerk
P. 0. Box 360277M
Pittsburgh, PA 15251
9

-------
—8—
VI. STIPULATED PENALTIES
If any of the following events occur, McCloskey
Corporation shall pay a stipulated penalty in the amount
prescribed below for each event, unless McCloskey’s failure to
perform the action in question was the result of persons or
events beyond the reasonable control of McCloskey, and McCloskey
provides notice of an expected delay at least 3 working days
prior to the date performance is required, unless 3 working days
advance notice is not practicable under the circumstances, in
which case McCloskey shall provide such advance notice as is
practicable under the circumstances. McCloskey’s notice shall
include an explanation of the steps taken to avoid the delay
and a new schedule for performing. The revised schedule must be
approved by EPA in writing:
1. failure to submit to EPA, for review, the draft article
within the time period specified in Paragraph V, Section C
above: $200 for each calendar day that submission of the draft
article is late.
2. failure to sub iit the article to the appropriate trade
journals within the time period specified in Paragraph V,
Section C above: $500 for each month that submission of the
article is late.
3. failure to submit to EPA, for review, the agenda of the
EPCRA § 313 seminar for McCloskey customers within the time
period specified in Paragraph V , Section D above: $200 for each
calendar day that the agenda is late.
000020

-------
—9—
4. failure to conduct the EPCRA § 313 seminar for
McCloskey customers within the tine period specified in
Paragraph V, Section D above: $250 for each calendar day that
the seminar is late.
5. failure to certify to EPA that the EPCRA § 313 seminar
for McCloskey customers was conducted within the time period
specified in Paragraph V, Section D above: $200 for each
calendar day that the certification is late.
6. failure to remit the civil penalty as agreed to herein:
an additional stipulated penalty of $100.00 er diem in addition
to interest as allowed by law.
7. Failure to remit the civil payment will result in this
matter being forwarded to the U.S. Department of Justice for
collection and all other remedies available at law.
VII. OTHER MATTERS
A. McCloskey has submitted evidence acceptable to EPA that
Chemicals 1 through 26 have completed PMN review and so
certifies by the signing of this Consent Agreement.
B. Nothing in this Consent Agreement and Consent Order
shall reliev licCioskey from complying with all applicable TSCA
regulations .r other applicable environmental statutes.
C. This Consent Agreement shall be binding upon the
Parties and in full effect upon the signing of the Consent Order
by Chief Judicial Officer or his designated representative.
000021’

-------
—10—
D. McCloskey’s obligations under this Consent Agreement
shall end when it has paid the civil penalty in accordance with
the Consent Order, and has completed the items specified in
Paragraph V, Sections C and D.
E. All of the terms and conditions of this Consent
Agreement together comprise one agreement, and each of the terms
and conditions is in consideration for all of the other terms
and conditions. In the event that this Consent Agreement (or
one or more of its terms and conditions) is held invalid, or is
not executed by all of the signatory parties in identical form,
or is not approved in such identical form by EPA ’s Chief
Judicial Officer or his designated representative, then the
entire Consent Agreement shall be null and void.
000022

-------
—11—
WE AGREE TO THIS:
For Complainant:
Michael F. Wood, Director
Compliance Division
Office of Compliance Monitoring
4 i—’ / (/ v2a’ ’ - ‘- ‘ ‘fl
Vr cent J. Giordano, Esq.
Tox.cs Litigation Division
I
_1
Frederick F. Stiehi
Associate Enforcement Counsel
for Pesticides and Toxic Substances
For Respondent:
The McCloskey Corporation

D vid J. Ha es,
Counsel to The Mc 1oskey Corp.
Hogan & Hartson
555 Thirteenth St., N.W.
Washington, D.C. 20004
Edward E. Reich, Acting
Assistant Administrator for Enforcement
and Compliance Monitoring
Robert
Katherine
000023

-------
CERTIFICATE OF SERVICE
I hereby certify that copies of the foregoing Consent Order
in the matter of The McCloskey Corporation, Docket No. TSCA-89-H-
04, were sent to the following in the manner indicated:
Certified Mail, Robert A. Katherine
Return Receipt Requested: Chairman
The McC]oskey Corporation
7600 State Road
Philadelphia, P1. 19136
First Class Mail, David J. Hayes
Postage Prepaid: Hogan & Hartson
555 Thirteenth Street, NW
Washington, DC 20004
ay Hand-delivery: Vincent Giordano, Attorney
Toxics Litigation Division
(LE— 134 P)
Office of Enforcement & Compliance
Monitoring
U. S. EPA, Headq art :rs
Bessie Hanimiel
Headquarters HEaring Clerk
U.S. EPA, Headquarters
Dated:M,4R -7 198
Brenda H. Selden, Secretary
to the Chief Judicial Officer
000024

-------
T I - I C
ft McCloskEv
‘ CORPORATION
Manufacturers of Alkyd Resins • Varn shes • Erni:Is ,ors • Sea’e s anc Natural Wood Fn’sries
. 1 1 —
-
2 _‘“E-tD A - - .t. _-. - -
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000025

-------
000026
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Don’t expect-
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Circie S on Reader AcItor Card
I .)fl-LjtY-( S

-------
- . —
j Contents
News
May was good for architecturals
Paint shipments were up across-the-board
year-to-date flat
I Construction outlook improves
J Dodge predicts boost due to dechning
mortgage rates
McGrenera heads Chicago PCA
Northern I l linois Li S attorney speaks
at annual meeting
Huber s CDtC society president
Members are conducted on tour
of Navistar truck facility
t-1oward G Sholl dead
Was 1958-59 Federation past president.
50-year member
SOCMA announces officers
New board members chosen at Tampa
Annual Meeting
Technical
Somerville talks to Baltimore SCT
fresents reporl on Technical Committee
dispersion project
Features
Compliance with the Toxic Substances Control Act
in the coatings industry
By Robert A Katherine and Gary A Wetp
CMA referral service answers public concerns
about chemicals
Departments
The Markets - EB and phthaluc drop
Technology On-Line
Coming Events
Obituaries
Financial Front
Editorial The power of creativity
New Products
Opportunities (Classifued
Advertisers Index
O ICRiCAN PAINT 6 COATINGS JOURNAL 1 ISSN CC565430) Is pu0i.0 5 00 *eeUy #IC6TI f. e Conneniw DaIly .Itues 7L7 1shAd
A O l 5 Aurleg conne 5or 0’ 5 S 00 Tel A6 by Anrercas Palni Journal Co 291 i Wasilaglan Ave Si LAwS MO 63i03 Seconti
: 1050 505iate ao or Si LOInS ‘ . 10 POSTMASTER Se ’a adAress c 3’qis is AMERICUA POiNT 6 COATINGS JOURNAL 29 1I
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Ate ‘I.
Membel
SCHOLD MACHINE
MIDWEST Dl’
ORIGINATORS OF TI!
2Ot WEST 64th PLACE CHICAGO. PU
312/458-3788 3U
Sales & Technical Hoc 1.
Oi’PORATE HEADQUARTERS
SOL.THERN DIVISION
( 139J Osk Street N
Si Pelurubuep Fl . 33716
M1J ‘70.1147
vi ;9i8o6 FA
To our customers and fr
Thank you very much. \
our 40th year and runni
We could not have mac
considerable trust and s’
Thank you one and all
it possible.
Sincerely,
The Folks at Schold Ma
Midwest & Southern Di
Circle 8 on Reader
OQOO
Monday
July 31, 1909
.1
Vol. 74, No. 3
•scl

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I MM,INE YOURSELF attending your
lirsi toiilpafly lx)Jrd ol directors ullectitig.
liioscvcr snu are there to e’pI ni a si
in II I ni I tue t the hi a rd after t lie I l’A I us
tu’iidticted an audit of sour oiIIpaily and
lound that ou arc not in conii,Itaitce with
the Fouc Substances (ontrol Act TS( Al
\ our dreams hasc turned into a nightmare
II that sounds lrcpusterotis. this article is
csscuiti.tI rcadiiig br you and the scitior
unauiageiiieilt ol your cOmpanY Ask your
self. “Is lily COiiiIldllY lit cOtiil)IIaIiCe with the
1 oxie Substance ( ontrol Act” II your corn
paiiy niauittlact tires paint produus, you
probably think ihat you arc exempt because
you inaiiulaciurc only nhixtures
II your cotnph.inee program stops there.
yu tu arc aliiiost sit rely 0111 iii comphancc wit Ii
I S( A. and it is Iiilpet.ttiVC (1181 OLi lcaiii
more ahoul TS( A .tiid the regulations that
the Ll’A uses to inplcuient the Act Alter
doing so. you must write and implement an
effective TS( A compliance program for
your cornp.iiiy Ivery company in the coat
iiigs niaiiulactui ing iildustry must have such
.1 LtIiIii ’li.tIii..C uiigr.tiii iii ,i uiiil ‘ e%ti. is.ii.il
lit’s tiI.iii(l.iIC(l hs the siaIiuic .tuRl icgiiI.iuii ii
In liii iiittl.ilitig CoiilIllLtil .c I l.lii, kccp iii
iiiiIiLI ili.tt sshile the Iat.t hut uir eiiiiipan
‘‘tily iii,iiiuilaettircs illixI Iii CS iil8 esenilit
yini lioni liavitig to Ide prein.iiiiil .icIttit’
01)1 ices, all ot Ret sect iouis 1)1 II Ic i cgt I kit KM iS
still apply In our coiiiiuny —l In is. viii t mns l
heconic aware of the otlicr iiiajor cecinuis
such as section 4 test rules. section 6 reguLi
lion (it custtiig CiieiiiILilS. scet ion 8 recoi ti
ket’piiig .inil ieporliiig. cetiniul I 3 regukilion
uI Uieiiiiuil intpoi ts. and uitlicr parts of sec-
tion 5 oil new chemical regulation The
following briel overview tif tIi icgiilatioiis
is a s.iinpling ol the issues that your coni
pliance progiani must address. ou should
constilt the regulations tlicrnsclvcs for the
details on how to implement the progiamc
siiuiiiii.ii tied tn the overview
• Aity company intending 10 manufacture
or import a new chemical substance lutist
filc a iircrnanufacturc notification (PMN) 90
djys pi or to niaiitifacture under ‘l’S(’A sec
111)11 5 ‘I his requirement ciialilcs Ll’A to
screen a new chemical before its conuner-
cial productioii or irnporlatioii
lii general terms, if tile EPA Finds that the
new cheiiiical may present au unreasonable
risk of injury to health or the environment.
or that it will he produced and rna enter
the environment in substantial quantities or
there may he significant or substantial
human exposure to it, and if there is insuf
fietciit information to permit a reasoned
evaluation of the effects of the chemical
substance, the EPA can restrict or prohibit
its rnaiuufacture, processing, distribution in
commerce. use or disposal Thesc orders may
restrict your use of a new chemical sub’
stance Once a chemical undergoes PMN
review, the LPA places it on the TSCA
Chci iiical Substance Invenlory.
The I MN rule does not apply to mixtures:
this exemption applies to most paint prod-
ucts Keep in mind, however, that thc com•
poncnts of the mixture must all be in the
TSCA (‘liemical Substance Inventory for
the exemption to be valid, and the mixture
must nieet the TSCA definition of a uiiixttirc
‘lien a tluetiuitji stillst,t net ii br liii’
lust nine iii .i new use •i ct it i tl h the
I PA iii a siguuilttaiit nest use i tile (or
“SN I. Ut there is .1 rc(l tiiicitlclit ilt.it the
I l’. hi’ i’ivcn 9(1 dats not iie Rehire I hat
clii i,iic,il substance L3n he used. CS Cii iii lie
ili nii ,il is in the ins cntor or has tussed
through the [ ‘MN process hoc .iiiotlicr use
oti iiiay huasc 11181 “significant new usc
hut den as a coiiip.inv tli.ut processes that
chem uc i I in to .i nit siti rc I or t’ .i ,nplc, one
.. hen iii .it widel v ticed iii t he coatings in
dustry, iiicth iii hut yt kctoiie, is suilijeci to
a “significant iicw use” rttle. with “an use”
triggering the SNL t K rcquirctneuits
‘I SCA sCetiun 5 also sets dowiu rules ap-
plicable to R&l) on new chemical stiR-
ctances’An exemption from the PMN rc
(lutrcnicntc exists for R& I) chenitcat
substances ii the work su tth those suihst.inucs
is supervised by a “technically qualified in
dtvidual” and the rnanufacturei has
cvalutatcd any lX)teiitiah risks associated with
the R& I) substance, notified the persons
ondiietiuig the R&D oh those risks, and
maiuitained certain recoi ds as to the R& I)
activity
Mdiiul.tciLiicis ,IIC rctltuiie(l Iii notils ails
pa it to win ,mn the K & I) sLihstj nec is ii is
ii ihti ted that t he substa iii e is an K & I ) stiR
staiiee onl . and 1 jinvide theni ss idi tile risk
eva Iua Iii iii resti its, t lie v slunt Id .t 1st, iiil unit
tic users 1)1 t hcui i cs it incihil ii cs u iidcr
‘I S(A .tiid of 1 SI A .upprosed dtspos l
methods br residuals Uscus of ;tii R&D sub
stance should not allow the substance to
enter conumeice until the PM N pci io U is
complete for the substauiuc’. and then must
follow any restrictions on the use of the cub
stance imposed by tile I ,PA 1 his process
may take sonic time, so all parties must hate
patience while it is Lt)itilllctetl
•l’SC’A section 4 in getieral icrtus. author
i/cs the l:PA to require test ing of chemical
stib,stances and mixtures if the L PA finds
that they “may present an Ltnrcasonahle risk
of injury to health or the ciuvutunnieni or
if they will he produied iii stibstaittial quan
lilies that result in significant csposure
l:t r exanitile, the El’ is currently pre
ill
‘hnii ’su a’, Pu,,,! i( ( ,,ai,,ns J , ,u,,,uI
in!, 3!. lv.’ v
A; oooo
41
Compliance with the Toxic
Substances Control Act
in the coatings industry
By Robert A. Katherine and Gary A. Weip
Robert ‘I Fsai!ieruse ias pr’s,du’ni wul
liatrinari ciii! .4 ii 0 ( 1% t Ice
pretulent tec’hnit ci i / he Mc C’loskes
(‘orp. Philadelphia Stare the article ii as
ItrIllen. McC’loskey tsas pureha.sed h)
1 lie I ‘a!spar Corp. Min ti i’i polic

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tulill ,Illl P( us \ ‘liii I l)IiIi)ii.Illt.e )it) l . 1111
l u lls! en Ver (lie PC lIt tiles. w ll lt h are among
lie 1 11 ( 15 1 LIII 1)1 11411 11 )’ Vi i )iJItd I ego LI Ilt)i)5
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tOllil lot spetiiit eiIil)ltt’llIt’u1l Ml)IieUIi ‘.
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I it’llltiihs i i i .111 tIlt_u. Il’.t tttuiillil.lhiLe 111( 1
‘lIlt tilt link
I A 1(11111)111%’ IN tilL S tittI cie.triy states I he
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t ilellultal i laiuue til (lie llI.Itei uul 81 1 (1 Its Chletil
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oi lii IX Ill res or ( W I plle I.i ry it InuposlI 1 1)1 IS. 1
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sI.hiice iuut’einors
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scriiitiig to tile I PA’s ‘C luellultais Ill) Ite lkilt
lug Roles ccl tile ttiiit_ii iiitieses clIelIlILlis
s(hilIttl i i ) V.111(t Ils 1St i ’ s lethllIheIllelits
H Sitiiscriptutui to the I PA iu.ulhiilg list itui
lilt’” 1St A C Ilellilculs iui i’iuiguess i lllhietimi.’
whit hi Is I1(li lhlSltCIi i i’. lile I PA C )lhlLc tul
‘I ‘ sic Stihsi.iuuces •illti ‘.t lIlt II 1)11)’. ides use
luil iil)Ii.hlt_L 1111 tue 1St A lLgtll.hhtnv ,ittItll
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4 Wi the .uiiti •iditpu .t Ll)IIII).IIl3 I S( A
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keell I eh dill II)’. iii Ct liii pita i lid
(1 RevIew (lie Lollipihallee prograni ‘.titli
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1 St A LI lhliu)ll.lilee
7 C ( Ih ltillet Ira uttlg for S ui llr ciltployees
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‘ 1St “¼ tI)llI( lilJlice
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dii ) uileg.uI . 1 11 u’.’itv I huthitedualely and contact
St I hIr tu)lIItXilit’ ZItIt)iIle%
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Illelils It) liahud lc I’M Ns Ii )OU company
Ill,IIl Iii,lLIIliCs 1 1It1dttLlS 11181 thti 1)01 qualIFy
huw t lie mutisinie exeniptioll I or exaiiipie. If
31111 111,1 I.e poiyniei s stiehu : 15 (XII ytIrel ha lies
1111 1 lustu III It I . Ii iti 1111’ uI I II ilu_’I t 11.11 i ’l L !’
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‘\li tiitt lu.e tllllfl)ii.llitt IlltlVl.111i ‘.tuII liuip
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‘Pet Il l iltill ) I lie I IA t.iIhs (II I tutu 441111
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.11 1111 1 1 ih ‘.ului lt.i’.e .111 IllulieL lute ttiIuuiiILhllt.e
U.S. ilItlIb si nal (Jilt 11)0k
is available iii print, on (apt’
Sprnlgfhcid, Va Jlliv 26 —. “1 lie U S
111111141 al Otutltttik. I 98 J i’itr.lhet I (or Oter
35 1) iludlustlues IS ,ttaihuhle Irl itul tile I iiuutcti
Sl.Ites i)tpat lIllelit 1)1 C IllIliIlt’ltc’S N,ulluiii. Ii
I eeiuillu,.ll Ihill lrililli l l lu S d Site II I I uiuteti
I oriuu or 1)11 i.llue
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st.IIlstItl.liiS alid ilithu lsli 3 .llihI%si, Ill the I )e
11 ,11 hiluc llt II I ( uIiluueiLe aunt uhhileu t’i)%UIl
ii )eiil .ugehithes. lilt! ueixn I I r ’. Ilk’S ,t11 Ill
tltistiv by uutltusuiy tfler’.,t’.t 4)1 (lie (IS
ecoiiocuiy
SIat,sI tea I niatei 1.11 IS coccI ed II I detaIl iiu
ii tiding Ilidt lst t v cii 1(11 il Ills ICt cones. Ii lithe
blows, einployiueul .tiid earil h ligs
lo order die hixik ‘.ersuoii Nattonal Tech
n lcal Iiilorinaton Service. 5285 Port Ro)al
Rd. Sprthlgfueld. Va 22141 Phone I7U3u
487 4650 Request Pit8tl l47tRl4kMh1 C oct
IS S42 95, pI us $3 luandluIg
lo otder tile dalataiws Naitonal Technu
cal Iliforiuu.tiholu Service. 5285 PorI ito)aI
Rd . Spriiugftcld. Va 221(11 i’Iionc 171131
4874650 For ASC II. relluesi P 1 389159412
KMII For I’I i(’Di(’. iequect P1389 159404
KM II.
Find out who’s been promoted
In American Point & Coatings Journal
I I
I ngl’rft ass I’sissss .V ( ulahsssgs Jcnsiiiiil ui /i I I t),55)

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xYz

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0
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
In the Matter of
ALCOLAC INCORPORATED ) Docket No. TSCA 89—H— 22
Respondent )
___________________________________________________________________________________ )
Notice of Treatement of Confidential Business Information
Portions of the attached Complaint require use of
information which Respondent submitted to the United States
Environmental Protection Agency (EPA) as Confidential Business
Information (CBI). Information in the Complaint constituting or
based on CBI has been deleted as indicated by the following:
(CBI deleted). The original Complaint containing CBI is filed
with the headquarters Hearing Clerk. It will itself be treated
as confidential unless and until Respondent waives
confidentiality thereto or EPA releases the information in
accordance with 40 CFR Part 2.
000085

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UNITED STATES
ENVIRONMENTA L 1 PROTECTION AGENCY
_____________________________ Docket No. TSCA 89—H-22
COMPLAINT AND NOTICE OF
In the Matter of ) OPPORTUNITY FOR HEARING
ALCOLAC INCORPORATED ) UNDER SECTION 16(a) OF
THE TOXIC SUBSTANCES
Respondent ) CONTROL ACT
This is a civil administrative action issued under the
authority of Section 16(a) of the Toxic Substances Control Act,
15 U.S.C. 2601 et !. • (hereinafter “TSCA”). The Complainant is
Michael F. Wood, Director, Compliance DivisioLl, Office of
Compliance Monitoring, United States Environmental Protection
Agency (EPA), who has been duly delegated the authority to
institute this action. The Respondent is Alcolac Incorporated,
Baltimore, Maryland.
This Complaint serves as notice that Complainant has reason
to believe that Respondent manufactured chemical substances in
violation of Sections 5, 8 and 15 of TSCA, 15, U.S.C. Section
2614, as follows:

-------
I
—2—
1. On August 1, 1984, May 20—21, 1986, and June 12, 1987,
inspections were conducted, by duly designated
representatives of the EPA, at Respondent’s facilities
located at 3440 Fairfield Road, Baltimore, Maryland and at
Randall Road, Sedalia, Missouri, respectively.
2. These inspections were conducted to determine Respondent’s
compliance with TSCA requirements.
COUNT I
3. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
4. Respondent is a “person” as defined in 40 CFR Section
720.3(x) and as such is subject to TSCA and the regulations
promulgated thereunder.
S. Respondent’s records revealed that Respondent manufactured
for commercial purposes the chemical substances as described
in Counts I— tV, respectively.
6. On these occasions, the chemicals identified in Counts I—Ill
of this Complaint, did not appear on the TSCA Inventory of
Existing Chemical Substances (“TSCA Inventory”) maintained
by the Administrator pursuant to 15 U.S.C. Section 2607.
000087

-------
—3—
7. Records revealed that Respondent manufactured a new chemical
substance, (CBI deleted), chemical abstract number (CBI
deleted), and iaentified by product code name (CBI deleted),
hereinafter designated as Chemical A.
8. Section 5(a)(l) of TSCA, 15 U.S.C. 2604(a) (1), provides that
no person may manufacture a chemical substance which does
not appear on the TSCA chemical substance inventory without
first submitting a Premanufacture Notification to the
Administrator of EPA at least 90 days before manufacturing
such substance.
9. Section 15(1) (B) of TSCA, 15 U.S.C. 2614(1) (B), provides
that it is unlawful for any person to fail or refuse to
comply with any requirement prescribed by Section 5.
Section 15(3) (B) of TSCA, 15 U.S.C. 2614(3) (B) provides that
it is unlawful for any person to fail or refuse to submit
reports, notices, or other information as required by TSCA.
10. Respondent’s records revealed that between October 1979 and
June 1986, Respondent manufactured (CBI deleted) pounds of
Chemical A for TSCA conunercial purposes. During this time
period, Respondent manufactured Chemical A on at least (CBI
deleted) separate occasions.
11. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical A, at least
ninety (90) days before manufacturing Chemical A, thereby
violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B).

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U
—4—
COUNT II
12. paragraphs 3 — 6 are hereby incorporated and realleged as if
fully set forth herein.
13. Records revealed that Respondent manufactured a new chemical
substance, (CBI deleted), CAS tt (CM deleted), and
identified by product code name (CBI deleted), hereinafter
designated as Chemical B.
14. Paragraphs 8 — 9 are hereby incorporated and realleged as if
fully set forth herein.
15. Respondent’s records revealed that from March 1982 through
December 1986, Respondent had manufactured (CBI deleted)
pounds of Chemical B for TSCA commercial purposes. During
this time period, Respondent manufactured Chemical B on at
least (CBI deleted) separate occasions.
16. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical B, at least
ninety (90) days before manufacturing Chemical B, thereby
violating TSCA Sections 5(a)(l)(A), 15(l)(B), and 15(3)(B).
COUNT III
17. Paragraphs 3 — 6 are hereby incorporated and realleged as if
fully set forth herein.
000089

-------
—5—
18. Records revealed that Respondent manufactured a new chemical
substance, (CBI deleted), CAS * (CBI deleted) and identified
by product code name (CBI deleted) , hereinafter designated
as Chemical C.
19. Paragraphs 8 — 9 are hereby incorporated and realleged as if
fully set forth herein.
20. Respondent’s records revealed that from October 1983 through
December 1985 Respondent had manufactured (CBI deleted)
pounds of Chemical C for TSCA commercial purposes. During
this time period, Respondent had manufactured Chemical C on
(CBI deleted) separate occasions.
21. Respondent failed to notify EPA of its intention to
manufacture the new chemical substance, Chemical C, at least
ninety (90) days before manufacturing Chemical C, thereby
violating TSCA Sections 5(a) (1) (A), 15(1) (B), and 15(3) (B).
COUNT IV
22. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
23. Information collected during the inspections and subsequent
information submitted by the Respondent revealed that
Respondent manufactured for TSCA commercial purposes, as
defined at 40 CFR Part 712.3, the following chemical
substances listed as chemical abstract service registry
numbers, (CAS *3) from January 1981 through December 1981:

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CAS $ Chemical Production Amt
(CBI deleted) Chemical D (CBI deleted)
(CBI deleted) Chemical E (CBI deleted)
24. According to 40 CFR Section 712.20(a), a person who
manufacture in bulk form one or more of the chemical
substances listed in 40 CFR Section 712.30 for commercial
purposes must submit a Preliminary Assessment Information
Report, (hereinafter referred to as a PAIR), to the
Administrator of EPA, as required under Section 8(a) of
TSCA.
25. Respondent is a “person” as defined in 40 CFR Section
712.3 (6).
26. Section 8(a)(l) of TSCA authorized the Administrator of EPA
to issue rules that requires reporting by manufacturers,
importers and processors of chemical substances. The PAIR
rules were promulgated on June 2, 1982 under 40 CFR Part
712, Subpart B entitled, Manufacturers Reporting——
Preliminary Assessment Information. Section 15(3) (B) of
TSCA, 15 U.S.C. 2614(3) (3) provides that it is unlawful for
any person to fail or refuse to submit reports as required
under TSCA.
27. According to 40 CFR Section 712.30(a), Respondent was
required to submit a PAIR for Chemicals D and E covering
their 1981 calendar year production on or before
November 19, 1982.
000091

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28. As of the date of EPA’s August 1, 1984 inspection,
Respondent had not submitted a PAIR for Chemicals D and E on
or before the November 19, 1982 reporting date as required.
29. On or about August 1, 1984, Respondent submitted PAIRs for
Chemicals D and E to the Agency pursuant to 40 CFR Section
712.30(a).
30. On or about November 7, 1986, two years after the August
1984 submissions, Respondent supplied the Agency with a
revised PAIR for Chemical D.
31. As described in Paragraphs 28 and 30 above, Respondent
violated Section 8(a) and 15(3)(B) of TSCA in that
Respondent failed to submit a PAIR for Chemicals D and E to
the Administrator of EPA for the reporting date as required.
COUNT V
32. Paragraphs 1 — 2 are hereby incorporated and realleged as if
fully set forth herein.
33. On or about June 18, 1978, the Respondent reported to EPA
that the Respondent had manufactured chemical substances
listed as CAS #s (CBI deleted and CBI deleted), hereinafter
designated as Chemicals F and C, substances for TSCA
commercial purposes since January 1, 1975.
34. On or about May 29, 1979, the Respondent reported to EPA
that the Respondent had manufactured the chemical substance
listed as CAS $ (CBI deleted) , hereinafter designated as
Chemical H, a substance for TSCA commercial purposes since
January 1, 1975.

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35. Pursuant to Section 8(a) of the Act, 15 U.S.C. Section
2607(a), EPA promulgated the “Inventory Reporting
Regulations”, codified at 40 CFR Part 710. 40 CFR Part 710
establishes regulations governing reporting certain sub-
stances for commercial purposes under Section 8(a) of the
Act.
36. Pursuant to 40 CFR Sections 710.3 and 710.4, all persons wno
manufactured and/or imported a chemical substance for a
commercial purpose during 1977 were required to submit
specific information to EPA concerning that chemical
substance for inclusion in EPA’S initial TSCA inventory of
chemical substances manufactured for commercial purposes
under the Act, and only persons who manufactured or imported
a chemical subtance for commercial purposes from January 1,
1975 to July 1, 1979 were permitted to report to EPA
concerning that chemical substance for EPA’S TSCA Inventory
of Chemical Substances.
37. Supplemental information submitted by the Respondent
subsequent to the inspections, revealed that chemical
substances F, C, and H cited in paragraphs 33 and 34 of this
Complaint had not been manufactured by Respondent for
commercial purposes at any time since January 1, 1975.
Respondent therefore was not permitted to report these
chemical substances for EPA’S TSCA Inventory of Chemical
Substances.
000093

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38. Respondent was the sole submitter of each of the chemical
substances E’, G, and H cited in paragraph 33 and 34 of this
Complaint for EPA ’s TSCA Inventory of Chemical Substances.
39. Pursuant to Section 15(3) of the Act, 15 U.S.C. Section
2614(3), it is lawful for any person to fail or refuse to
establish and maintain records or to submit the reports,
notices or other information as required by the Act or a
rule thereunder.
40. As described in Paragraphs 33, 34, and 37 above, Respondent
violated Sections 8(a) and l5(3)(B) of the Act, 15 U.S.C.
Sections 2607(a) and 2614(3) (B) by reporting chemical
substances F, G, and H as chemicals manufactured by
Respondent for commercial purposes.
PROPOSED civir PENALITY
Section 16 of TSCA, 15 U.S.C. Section 2615, authorizes the
assessment of a civil penalty of up to $25,000 per day for each
violation of TSCA. Based upon the facts alleged in this
Complaint, and upon the nature, circumstances, extent and gravity
of the violations alleged, as well as Respondent’s history of
prior violations of TSCA, the degree of culpability and such
other matters as justice may require, the Complainant proposes
that Respondent be assessed the following civil penalty for the
violations alleged in this Complaint:

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COUNTS I - III
Failure to notify of intention to
manufacture a new chemical substance:
15 U.S.C. 2604 (a)(1)
15 U.s.c. 2614 (1) (B)
15 u.s.c. 2614 (3)(B)
.... $ 273.000
...... $ 16,500
. $ 145.000
COUNT ..... $ 434,500
COUNT IV
Failure to submit PAIR reports
as required:
15 U.S.C. 2607 (a)(] ,)
15 U.S.C. 2614 (3) (B)
COUNT ................. .. $ 68,378
COUNT V
False reporting of chemical substances
as manufactured for commercial purposes.
Respondent is sole submitter of each
cnemical to EPA TSCA Inventory:
15 U.S.C. 2607 (a)(1)
15 U.S.C. 2614 (3)(B)
COUNT . . . . . . . . . . $ 51, 000
TOTAL PROPOSED CIVIL PENALTY ......... $ 553878
000095

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NOTICE OF OPPORTUNITY TO
REQUEST A HEARING
As provided in Section 16(a) (2) (A) of TSCA, you have the
right to request a formal hearing to contest any material fact
set forth in this Complaint or to contest the appropriateness of
the proposed penalty. Any hearing requested will be conducted in
accordance with the Administrative Procedures Act, 5 U.s.c.
Section 551 et seq. , and the Consolidated Rules of Practice
Governing the Administrative Assessment of Civil Penalties , 40
CFR Part 22 ( “Consolidated Rules of Practice”) . A copy of the
Consolidated Rules of Practice accompanies this Complaint.
To avoid being found in default, which constitutes an
admission of all facts alleged in the Co nplaint and a waiver of
the right to a hearing, and having the above penalty assessed
without further proceedings, you must file a written Answer
within twenty (20) days of receiving this Complaint . Pursuant to
the Consolidated Rules of Practice, your Answer must clearly and
directly admit, deny, and/or explain each of. the factual
allegations contained in this Complaint with regard to which you
have any knowledge. If you have no knowledge of a particular
fact and so state, the allegation is considered denied. Failure
to. deny any of the allegations in this Complaint will constitute
an admission of the undenied allegation.

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The Answer shall also state the circumstances and arguments,
if any, which are alleged to constitute the grounds of defense,
and shall specifically request an administrative hearing, if
desired. If you deny any material fact or raise any affirmative
defense, you will be considered to have requested a hearing.
The Answer must be filed with:
Headquarters Hearing Clerk (A—].l0)
United States Environmental Protection Agency
401 M Street, S.W., Room M3706
Washington, DC 20460
Please send a copy of the Answer an all other documents which you
file in this action to Vincent Giordano, the attorney assigned to
represent EPA in this matter, at:
Toxics Litigation Division (LE—134P)
Office of Enforcement and Compliance Monitoring
U.S. Environmental Protection Agency
401. H Street, S.W., Rm. NE 113A
Icasnington, D.C. 20460
INFORMAL. SETTLIEMENT CONFERENCE
Whether or not you request a hearing, you may confer
informally with EPA through Mr. Giordano regarding the facts of
this case, or amount of the proposed penalty, and the possibil. ty
of settlement. An informal settlement conference does not,
however, affect your obligation to file a written Answer to the
Complaint.
000097

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EPA has the authority, where appropriate, to modify the
amount of the proposed penalty to reflect any settlement reached
with you in an informal conference. The terms of such an
agreement would be embodied in a Consent Agreement and Final
Order (“CAFO”). A CAFO signed by EPA and you would be
binding as to all terms and conditions specified therein upon
signature by the EPA Chief Judicial Officer.
Please be advised that the Consolidated Rules of Practice
prohibit any ex parte (unilateral) discussion of the merits of
any action with the Administrator, Cnief Judicial Officer,
Administrative Law Judge, or any person likely to advise these
officials in the decision of the case, after the Compliant is
issued.
PAYMENT OF PENALTY
Instead of filing an Answer requesting a hearing or
requesting an informal settlement conference, you may choose to
pay the proposed penalty. Such payment should be made by
sending a cashier’s or certified check payable to the United
States of America in the amount of the penalty assessed in this
Complaint. The check should be mailed to:
EPA-Washington
(Hearing Clerk)
P.O. Box 360277M
Pittsburgh, PA 15251

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