United States
Environmental Protection
Agency
Washington, DC 20460
OPA 100/0
April 1981
Administration
of the
Toxic Substances
Control Act (1980)
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Contents
Introduction
Implementing organization
Table 1: Implementation of TSCA, by Section of
the Law, During Calendar Year 1980
Section 4: Testing of Chemical Substances and
Mixtures
Testing standards
Health effects testing standards
Chemical behavior testing standards
Interagency Testing Committee
Proposed testing rules
Testing costs
Testing rule schedule
Section 5: Notification and Review of New Chemicals
Premanufacturer notification
PMN rule
Table 2: Section 5 PMN Actions or Other
Dispositions, January-November 1980
Importer clarification
PMN costs
New-chemical testing guidance
PMN review
Extension of review period
Section 5(e)
Table 3: Overview of PMN Activities,
April 1979-December 1980
New chemical follow-ups
Section 6: Regulation of Hazardous Chemical
Substances and Mixtures
Chemical control, PCBs
Final control action, PCBs
Final control action, TCDD
Rulemaking proceeding initiated, CFCs
Proposed control action, asbestos in schools
Potential asbestos substitutes and use rulemaking
proceeding
Section 8: Reporting and Record-Keeping
Chemical information reporting
Section 8(a)
Proposed rule, section 8(a)
Proposed asbestos rule, section 8(a)
Proposed rule, section 8(a), generic small-business
exemption standards
Proposed rule, section 8(c)
Proposed rule, section 8(d)
Section 8(e)
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Section 9(d): Relationship of TSCA to Other
Federal Laws 12
Coordination with other chemical-control programs.. 12
Toxic Substances Priority Committee (TSPC) 12
Interagency Regulatory Liaison Group (IRLG) 12
Section 16: Enforcement 13
Table 4: Administrative Civil Actions Taken Under
Section 16 of TSCA Through FY 1980: Complaints
Issued, Cases Completed, and Amount Assessed
(by Region) 13
Section 28(c): State Programs 15
Table 5: State Cooperative Agreements Program,
1980-1981 15
Section 30: Litigation 16
Environmental Defense Fund, Inc., v. Environmental
Protection Agency 16
Olin Corporation v. EPA, General Electric Company
v. EPA, and Aluminum Co. of America v. EPA .... TfL
Dow Chemical Company v. Douglas Costle
Warren County v. State of North Carolina, etal
T. Mitchell Langdon era/, v. James B. Hunt era/ 16
Natural Resources Defense Council (NRDC) v. Costle 16
Vertac Chemical Corporation v. EPA 16
Aluminum Company of America and Northwest
Alloys, Inc. v. Donald Dubois, Douglas Costle,
and Environmental Protection Agency 16
Other TSCA Activities 17
TSCA section 12(b) 17
TSCA section 13 17
TSCA section 20 17
TSCA section 26(a), Industry Assistance Office 17
Innovation study 17
Administrator's Toxic Substances Advisory
Committee 18
Science Advisory Board 18
EPA Research Committee 18
International Activities 18
Major Problems 19
Implementation of section 4 19
PCB remand 19
Recommendations for Additional Legislation 19
Appendix 20
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Introduction
This Report to Congress summarizes
progress made during 1980 by the
Environmental Protection Agency (EPA)
in implementing the Toxic Substances
Control Act (TSCA). It fulfills the
congressional reporting requirements of
the Act, including those contained in
sections 30, 9(d), and 28(c) of TSCA,
and reports on broader TSCA program
activities from the beginning of fiscal
year 1980 through the end of calendar
year 1980 (October 1979-December 1980).
In enacting TSCA, Congress established
a number of new requirements and
authorities for identifying and controlling
toxic chemical hazards to human health
environment. Accordingly,
now exist under TSCA to
information about the toxicity of
particular chemicals and the extent to
which people and the environment are
exposed to them, to assess whether
they cause unreasonable risks to
humans and the environment, and to
institute appropriate control actions after
carefully weighing their risks against
their benefits to the Nation's economic
and social wellbeing.
To insure wise and informed decision-
making by the government, TSCA gives
EPA authority to gather certain kinds of
basic information on chemical risks from
those who manufacture and process
such substances. The law also enables
EPA to require companies to test the
toxic effects of specified existing
chemicals, and stipulates that the
Agency review the safety of all new
chemicals before they are manufactured.
To prevent unreasonable risks, EPA
under TSCA may select from a broad
range of control actions, from requiring
hazard-warning labels to outright bans
on the manufacture or use of especially
hazardous substances. TSCA authorizes
EPA to regulate a chemical's
unreasonable risks at any stage in the
substance's life-cycle: in manufacturing,
processing, distribution in commerce,
use and/or disposal.
In prescribing these authorities.
Congress intended that prudence be
exercised in implementing TSCA.
Accordingly, EPA's actions under TSCA
recognize the implicit reality that the
chemical industry plays a vital role in the
economy of the United States: its
annual sales approach $146 billion and
generate an annual trade surplus of
about $10 billion; the production of
chemicals and allied products accounts
for roughly 6 percent of the Gross
National Product; and the industry
employs about 1.1 million people. More
than 55,000 chemical substances are
presently manufactured or processed for
commercial use in the United States,
and several hundred more are intro-
duced each year.
Under TSCA, EPA must also remain
sensitive to the Act's potential impact
on small, nondiversified companies.
Research done by the Agency shows
that chemical production is distributed
very unevenly among the 115,000
establishments involved in the
manufacture or processing of chemicals.
Of these establishments, 32 percent
produce only one chemical product, and
63 percent produce five or fewer. Most
chemical firms are small—53 percent
employ fewer than 100 people—although
relatively few large companies contribute
most of the total quantity manufactured.
One of the main assumptions underlying
TSCA is that too often, the hazards of
particular chemicals have been
recognized only after extensive harm has
occurred to human health and the
environment. Asbestos, polychlorinated
biphenyls (PCBs), and the flame-
retardant chemical TRIS are well-known
examples. There also is justifiable
concern about the many other
chemicals—many of them substances in
common or rapidly growing use
throughout society—whose ill-effects
have never been adequately determined
through laboratory testing. In other
instances, adverse effects are suspected
but have not been proven to the extent
necessary for regulatory decision-
making. Rather than imposing the
financial burdens of answering the most
pressing of these questions directly on
the U.S. taxpayer, TSCA makes it
industry's responsibility to develop
missing data where there is a bona fide
indication of potential risk.
The Report describes EPA's TSCA
programs for gathering information,
performing risk assessments, and
controlling hazardous chemicals, and
discusses progress made in each of
these areas during and beyond the last
year. The Agency's basic approach in
implementing TSCA has been to use the
law's various tools to strategically
stimulate better and more timely
industry assessments of chemical
risks—as often as possible without the
need for formal regulation. In addition to
holding down the burdens of
government regulation on private
industry, this approach should lead to
more rapid and cost-effective
achievement of the Agency's main
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statutory goals than would a chemical-
by-chemical regulatory approach. In a
number of instances, for example, when
the TSCA program has identified a
suspect chemical, industry has
voluntarily undertaken such risk-
reduction measures as improving
in-plant emission controls and instituting
data-gathering programs such as toxicity
testing.
Implementing organization:
Implementing TSCA is the responsibility
of the EPA Office of Pesticides and
Toxic Substances. A major
reorganization of this office took place
in August 1980; TSCA program
responsibilities once shared by three
Deputy Assistant Administrators are
now consolidated under a single Deputy
Assistant Administrator. Two of the
three Deputy Assistant Administrator
positions were abolished, and a new
position was created, that of Associate
Assistant Administrator for Toxics
Integration; as before, overall
responsibility for the TSCA program
continues to be that of the Assistant
Administrator for Pesticides and Toxic
Substances, a position which reports
directly to the Administrator. Changes
brought about by this reorganization are
resulting in more efficient coordination
and more streamlined decision-making
through new institutional mechanisms
for setting policy, more discriminating
allocations of resources, and program-
wide tracking of important projects.
(See Table 1, Implementation of TSCA
by Section of the Law, During Calendar
Year 1980.)
Table 1. Implementation of TSCA, by Section of the Law, During Calendar Year 1980
Section of law
4(a)
4(a)
4(c)
4(b)
5(e)
5(a)
5(e)
5
5(a)
5(a)
5(a)
6(a)
6(a)
6(a)
6
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Section 4: Testing of Chemical Substances and
Mixtures
Section 4 of TSCA gives EPA authority
to require manufacturers or processors
of existing chemicals (i.e., those already
in commerce) to test the toxic effects of
certain designated substances. EPA
exercises this authority by rule only
when it can make certain statutory
findings about the substance involved
and when industry fails to develop the
needed data on its own. These required
findings are that a chemical may present
an unreasonable risk; that there are
insufficient data already available with
which to perform a reasoned risk
assessment; and that testing is
necessary to provide such data. A
testing rule also may be based on an
Aency finding of substantial production
sure to humans or the
nment, in addition to findings of
insufficient data and need for testing.
Testing standards: Testing required by
rule is performed according to
prescribed standards promulgated by
EPA in close consultation with other
government agencies, non-government
scientific experts, industry, foreign
governments, and the general public.
These standards define precise and
enforceable scientific procedures for
performing the required testing, thereby
assuring uniformly reliable and
consistent results from a variety of
domestic and foreign sources of data.
EPA is issuing generic testing standards
for various physical/chemical properties,
health effects, and environmental
effects, rather than issuing separate
standards for each chemical-specific
testing rule it writes. These generic
standards invite uniformity in the
acquisition of data and facilitate
consistency with existing domestic and
international testing procedures. The
s are incorporated by reference
^emical-specific testing rules and
modified as necessary to fit a
chemical's special requirements.
Health effects testing standards: Health
effects standards for acute, subchronic,
and chronic toxicity, oncogenicity
(tumors), mutagenicity (gene mutations
and chromosome aberrations),
teratogenicity (birth defects),
reproductive effects, metabolic studies,
and Good Laboratory Practices (GLPs)
were proposed in 1979. In 1980,
substantial effort was devoted to
reviewing these proposed standards in
response to numerous public comments.
Also, significant effort was made to
harmonize TSCA health testing
standards with those of other U.S.
Government agencies in the Interagency
Regulatory Liaison Group (IRLG), and
with international testing standards
developed by the 24-nation-member
Organization for Economic Cooperation
and Development (OECD). These tasks
have largely been accomplished, and
final TSCA health testing standards will
be published in 1981.
Chemical behavior testing standards: In
1980, EPA proposed five standards for
evaluating the behavior of chemicals
released into the environment. These
standards address the measurement of
several chemical and physical properties,
that pertain to the determination of how
a chemical migrates through the
environment. The proposal also includes
Good Laboratory Practice (GLPs)
standards for performing environmental
testing. The proposed GLPs cover the
management, operation, and
maintenance of facilities and equipment
in a testing program.
These proposed standards are the first
in a series of environmental testing
standards scheduled for proposal in
1981. Substantial effort was devoted in
1980 to harmonizing the TSCA
environmental testing standards with
those of the other IRLG agencies and
with the OECD testing standards.
Interagency Testing Committee: An
Interagency Testing Committee (ITC)
was established under TSCA to
recommend chemicals to EPA for
priority testing under section 4 of the
Act; the ITC cannot recommend more
than 50 priority chemicals or chemical
groups at any given time. Within 12
months of EPA's receipt of individual
ITC recommendations, the Agency must
either initiate rulemaking for requiring
testing or publish its reasons for not
doing so.
Proposed testing rules: On July 18,
1980, EPA proposed the first TSCA
testing rule under authority of section
4(a) of the Act. The proposed rule
would require testing of chloromethane
and selected chlorinated benzenes, all of
which had been recommended for
priority testing by the ITC. On the same
date, EPA also announced its intention
not to require additional health effects
testing of acrylamide, which also had
been recommended for priority testing
by the ITC. (See below.)
The proposed chloromethane rule would
require testing for oncogenicity (tumor-
causing properties) and teratogenicity
(induction of structural birth defects).
This proposal was based on the finding
that chloromethane may cause these
adverse effects, and that there currently
are insufficient data in these areas.
The proposed chlorobenzene rule would
require testing 11 structurally related
chemicals for oncogenicity, structural
teratogenicity, and reproductive,
chronic, and subchronic effects, based
on the potential that these substances
may present an unreasonable risk. Initial
testing would be performed on 6 of the
11 substances, with decisions on the
remaining ones pending review of
testing performed on the first group.
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EPA's proposed decision not to require
additional health effects testing on
acrylamide is based on the finding that
sufficient evidence exists that it is a
potent neurotoxin at very low levels; the
Agency also found that industry-
sponsored carcinogenicity testing was
already under way. As a result, industry
testing resources can now be devoted to
chemicals about which less is known,
and EPA will be able to determine
whether regulatory controls are needed
to reduce acrylamide's known and
potential risks without further testing.
Testing costs: Under TSCA, EPA is
required to establish an equitable
procedure for distributing among the
various manufacturers and processors of
a chemical the costs of testing that
substance under a section 4 rule. This
requirement is partially implemented in
the proposed rule on chloromethane and
the chlorinated benzenes by providing
policies and procedures for exemptions
from the rule to avoid duplicative
testing. In 1980, EPA also has been
developing a proposed reimbursement
rule that would provide the structure for
determining how exempt companies
would share in the testing costs incurred
by the company performing the tests.
This rule would call for voluntary cost-
sharing wherever possible; EPA would
be involved only to settle disputes that
individual companies bring before the
Agency because of their inability to
resolve the issues themselves.
Because the first TSCA testing rules
have been proposed for public comment
and have not yet taken effect, no costs
for testing chemicals were actually
borne by industry in 1980.
Testing rule schedule: The ITC has
submitted a total of seven priority lists
to EPA; they include 23 individual
chemicals and 20 chemical groups or
categories the committee wants EPA to
consider for testing rules. However,
because of a lack of testing standards,
delays caused by an extensive
information-gathering and assessment
process for evaluating an ITC
recommendation, difficulties in hiring a
full staff for the Office of Toxic
Substances, and other problems, EPA
has not been able to initiate rulemakings
in response to the ITC recommendations
within the one-year period Congress
provided for making a decision. In 1979,
the Natural Resources Defence Counsel
(NRDC), challenged EPA's reasons for
not initiating these rulemakings. On
February 4, 1980, the court announced
its decision in NRDC's favor and
instructed EPA to establish a schedule
for responding to the backlog of ITC
recommendations. The court has not yet
issued a final order, however. (See the
"Litigation" section in this Report.)
In response to this lawsuit and to EPA's
own concerns about the section 4
program, the Agency has reevaluated
and substantially modified its processes
for evaluating ITC recommendations and
for developing section 4 rules. This
should contribute to more efficient and
timely testing rule development
future.
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Section 5: Notification and Review of New
fihemicals
The authors of TSCA recognized that
health and environmental considerations
are more easily addressed before than
after a chemical is produced and
introduced into commerce. Thus, under
TSCA EPA has a series of special
authorities for assessing and acting to
prevent new-chemical risks and those
arising from significant new uses of
existing chemicals previously subjected
to the new-chemicals review program.
In using these authorities, however, the
Agency must remain vigilant to not
unduly impeding the technological
innovation of new chemicals. Also, the
Act provides for exempting certain new
chemicals from notification; for
ample, new substances manufactured
ISnall quantities for use only in
arch and development are exempt
from section 5 notification requirements.
TSCA also allows the Agency to grant
an exemption for new chemicals used
for test-marketing purposes, if doing so
will pose no unreasonable risks of injury
to health or the environment. EPA has
received a total of 50 test-marketing
applications: it has granted 34 such
applications and denied 2; 3 were found
not be bona fide test-marketing
applications; and 11 remain under
review.
Premanufacture notification: The heart
of the new-chemical review program is
the premanufacture notification (PMN)
requirements created by TSCA. Section
5 requires manufacturers or importers to
give EPA 90-day advance notification of
their intent to introduce a new chemical
substance into commerce, "new" being
defined as any commercial chemical not
listed on the TSCA inventory of existing
substances. They must also submit
available risk-related data including
results of relevant health and safety
studies, projected production or import
volumes, exposure estimates, and
intended methods of disposal. Even
though the Agency is required to
ascertain whether a new chemical poses
unreasonable risks, it cannot require
manufacturers to perform prescribed
testing of new chemicals.
Based on its review of submitted
information, EPA may act under section
5(e) or 5(f) to reduce or eliminate
unreasonable risks that exist or may
exist. The Agency also may issue a
significant new-use rule requiring
manufacturers or processors to notify
EPA in the future if they intend to
produce or process a chemical for uses
beyond those given in their original
notice, which are significant in health
and environmental terms.
By late 1980, the rate of PMNs received
by EPA was about 50 per month. A
number of notices contained insufficient
information to assess whether the notice
chemicals posed unreasonable risks. In
several of these cases, the Agency
prepared orders prohibiting or limiting
the production of the new chemical until
and unless the manufacturer submitted
additional data. In some cases, the
information was submitted and no
control action was needed. In others,
manufacturers withdrew the substances
from the process, thus dropping
temporarily or permanently their plans to
produce the substances. (See Table 2.)
PMN rule: On August 15, 1980, the
Agency proposed a rule extending PMN
reporting requirements to certain
chemical processors. The Agency
clarified its overall interim PMN policy in
a November 7, 1980, Federal Register
notice. This notice discusses PMN
notice contents, use of notice forms,
confidentiality of submitted information
and the development of test-marketing
exemptions.
Table 2. Section 5 PMN Actions or Other Dispositions,
January-November 1980
EPA action or No.
other disposition chemicals PMN status
Mfr. agreed to test
Mfr. agreed to test
5(e) order proposed
5(e) order developed .
Mfr. agreed to test
Mfr. agreed to test
PMN reviewed by EPA
5(e) order proposed
Negotiations
Mfr. assessing concerns
Mfr. assessing concerns
PMN reviewed by EPA
Mfr. agreed to test
Negotiations
1
1
6
1
1
Z
1
1
2
1
1
2
1
1
Completed
Completed
Withdrawn
Withdrawn
Labeled
Review suspended
Withdrawn
Withdrawn
Review suspended
Review suspended
Review suspended
Withdrawn
Review suspended
Review suspended
Date
1/80
4/80
5/80
5/80
6/80
9/80
9/80
10/80
10/80
11/80
11/80
11/80
11/80
11/80
TOTAL
22
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Importer clarification: In response to
public comments, EPA published a
clarification of the definition of
"importers" previously proposed in the
Federal Register on January 10, 1979.
This clarification states that the principal
importer, as defined in the clarification,
would be responsible for submitting the
PMN. The clarification responds to
issues raised in previous public
comments and will be incorporated into
the final PMN rules to be issued in 1981.
PMN costs: On November 13, 1980, in a
further step toward completing the final
PMN rules to implement section 5, EPA
published its "Proposed Economic
Impact Analysis" and "Draft Regulatory
Analysis" of the proposed PMN rules.
New-chemical testing guidance:
Premanufacture assessment of new-
chemical risks is a critical element of the
overall TSCA strategy for preventing
unreasonable risks to health or the
environment. EPA's ability to perform
this function depends on the quality of
data submitted in PMNs: the better the
data, the more confident the risk
assessment. Therefore, a high-priority
activity in 1980 was to develop non-
enforceable guidance for manufacturers
to follow in testing new chemicals. This
guidance is identical to international
premarket testing recommendations
developed by the OECD and agreed
upon in 1979 by the United States (see
International activities), and was
published by EPA early in 1981. It
identifies a base set of data that are
generally needed to conduct
premanufacture assessments; in
addition, it calls for flexible application
of this base set to accommodate the
diverse types of chemicals and exposure
situations represented in actual PMNs.
PMN review: EPA screens each
incoming notice to segregate chemicals
that do not appear to present an
unreasonable risk from those that need
a more thorough and detailed risk
assessment. For those subject to a
detailed assessment, EPA considers all
data and information supplied by the
manufacturer, as well as inferential
information drawn from data on
structurally similar chemicals already in
commerce. Based on this review, EPA
determines whether any action needs to
be taken to reduce risk. If EPA takes no
action, the manufacturer may proceed
to manufacture the chemical. If EPA
perceives a potential unreasonable risk,
any of the actions that appear in Table 3
may be taken.
Extension of review period: In some
cases, TSCA authorizes an extension of
the 90-day review period for up to an
additional 90 days, to permit completion
of the detailed assessment. In 1980, the
review period was extended for 21 of
the 383 notices submitted. (See Table 3.)
Table 3. Overview of PMN Activities,
April 1979-December 1980
Total number submitted 383
Still under review - 100
Review period extended 21
Referral to other programs- - 18
In line for SNUR - 45
Section 5(ei: Section 5(e) of TSCA
authorizes EPA to propose an order to
regulate the manufacture, processing,
distribution, use, or disposal of a new
chemical pending development of
information with which the Agency can
make a reasoned evaluation of the
chemical's health and environmental
effects. This authority is used when
there is reason to believe that a
chemical will have significant or
substantial exposure or may present an
unreasonable risk of injury to health or
the environment, but where the
manufacturer has not voluntarily
submitted sufficient data for a reasoned
risk assessment. For example,
preliminary testing data or a structur
analogy to a known toxic chemical^
reveal that the chemical could pr
an unreasonable risk. If the intended use
would lead to significant human or
environmental exposure, but the
manufacturer did not voluntarily submit
appropriate information to support a risk
assessment, then EPA could issue a
section 5(e) order prohibiting or limiting
manufacture of the chemical or certain
of its uses, pending submission and
evaluation of the requested information.
Under section 5(e), EPA may also act if
there is a lack of sufficient data, and the
chemical will be manufactured in
substantial quantities so as to result in
substantial human or environmental
exposure.
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During 1980, EPA proposed orders
concerning eight new chemical
substances. In the first instance, EPA
had received PMNs for a group of six
chemicals intended to be used in the
manufacturing of plastics. While the
notices were being evaluated, the
National Cancer Institute released
preliminary testing results showing that
another chemical of the same type
caused cancer in rodents. In addition,
structurally similar chemicals were
known to be toxic to aquatic life. When
EPA issued a proposed 5(e) order on the
basis of these concerns, the
manufacturer withdrew its notices. Later
during 1980, EPA proposed a 5(e) order
evidence indicated that the
substance was likely to be a skin
sensitizer. Again, the manufacturer
withdrew its notice. In one other case,
EPA had completed drafting of a 5(e)
order, but the manufacturer withdrew its
notice before the order could be
formally proposed.
On six other occasions in 1980,
manufacturers voluntarily withdrew
notifications of new chemicals that EPA
had identified or was considering for
section 5(e) orders. In each case, EPA
noted the possibility of significant
toxicity or exposure, and the available
information was insufficient for a
reasoned assessment of whether
regulation was warranted. (See Table 2
for a summary of the actions taken by
EPA in the PMN program). In such
cases, normally the Agency attempts to
elicit voluntary cooperation from
industry, resulting in negotiated
withdrawal or suspension of a notice
pending adequate testing or the
development of a safer substitute. These
lufacturers may resubmit their
_tes at any time when additional
Srmation becomes available, or in the
interim they may develop safer
substitutes for the withdrawn chemicals.
New chemical follow-ups: Because
production volume, manufacturing sites,
uses, and disposal practices may all
change significantly over time in ways
that cannot be foreseen at the time a
risk assessment is performed on a PMN,
EPA laid groundwork in 1980 for a
program to monitor commercial
development of selected new chemicals
after they have passed through the PMN
assessment. Only carefully selected
PMN chemicals will be subject to the
program.
EPA is developing the policy and
procedural framework through which
manufacturers and processors would
notify the Agency about significant new
uses for selected chemicals that have
been through a premanufacture risk
assessment. TSCA provides authority
for such rules based on consideration of
changes in production volumes, uses, or
other factors affecting exposure.
In November 1980, EPA proposed the
first chemical-specific significant new
use rule (SNUR). This proposed rule
would require a manufacturer or
processor to notify the Agency 90 days
in advance of significantly increased
production (as defined in the rule) for
the use described in the original PMN,
or manufacture or processing for any
use not in the PMN. Although
concerned that the substance may be
toxic, EPA did not take regulatory action
on this PMN chemical because
anticipated production volume was low,
exposure controls at the manufacturing
site were strict, and extremely limited
exposure was anticipated from the
stated use. Promulgation of this
chemical-specific SNUR, scheduled for
early 1981, will permit a second review
before a chemical substance is
manufactured or processed for other
uses or in significantly higher volumes.
By December 1980, approximately 50
other chemicals for which PMNs had
been submitted had been identified as
candidates for SNURs. In each case,
EPA had significant concerns about
chemical toxicity or potentially high
future exposure.
EPA's use of the follow-up reporting
and SNUR authorities in TSCA
exemplifies the Agency's flexible
regulatory strategy for TSCA discussed
in the Introduction. EPA expects that
identification of a chemical for follow-up
reporting will signal concern for
potential future risks and that
manufacturers and processors will often
respond by seeking methods of
production or new uses that will
minimize risk. In addition, the Agency
expects manufacturers and processors
to often voluntarily perform appropriate
toxicity tests before manufacturing a
chemical for uses that would result in
greater human or environmental
exposure.
The significant new use notice
requirements do not become effective
unless certain specific changes in
production volume, end use, or other
factors occur in the manufacturing or
processing of chemicals subject to
SNURs. Therefore, the reporting burden
will fall only on manufacturers and
processors of specific chemicals, and
then only if they manufacture or process
the chemicals for uses that may involve
significant increases in exposure over
what was proposed in the PMN or
current uses of chemical substances on
the TSCA Revised Chemical Substances
Inventory.
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Section 6: Regulation of Hazardous Chemical
Substances and Mixtures
Polychlorinated
Biphenyls (PCBs)
Chemical control: Under section 6 of
TSCA, EPA has the authority to prohibit
or limit the manufacture, processing,
distribution in commerce, use, or
disposal of a chemical already in
commerce that is found to pose an
unreasonable risk to human health or
the environment. A number of possible
control options are available, ranging
from total prohibition to labeling. In
1980, EPA undertook activities intended
to lead to control actions against
polychlorinated biphenyls (PCBs),
chlorofluorocarbons (CFCs), asbestos,
and 2,3,7,8-tetrachlorodibenzo-para-
dioxin (TCDD).
Final control action, PCBs: In TSCA,
Congress singled out PCBs alone for
both immediate regulation and phased
withdrawal from the market; the only
exceptions to this are where EPA grants
authorizations or exemptions or creates
exclusions for specific activities. PCBs
are of concern because tests on
laboratory animals show that they
cause, among other effects.
reproductive failures, gastric disorders,
skin lesions, and tumors. Moreover,
PCBs persist when released into the
environment and tend to accumulate in
tissues of living organisms. This means
that as PCBs move up in the food chain
toward humans, their concentration and
thus their potential for harm increases.
Action against PCBs was initiated in
February 1978, when EPA issued final
PCB marking and disposal rules. Fifteen
months later, the Agency promulgated a
final rule banning the manufacture,
processing, distribution, and non-totally
enclosed uses of PCBs.
In July 1979, the Environmental Defense
Fund (EOF) filed a suit against EPA
challenging aspects of the Agency's
final PCB ban rule. On October 30,
1980, the court ruled in favor of EOF on
two of the three major issues in the
case, and remanded certain portions of
the rule to EPA for further proceedings.
(See the "Litigation" and "Major
Problems" sections of the Report.)
On May 9, 1980, because of the serious
potential consequences to public health
from food accidentally contaminated
with PCBs, EPA, the U.S. Department
of Agriculture, and the U.S. Food and
Drug Administration simultaneously
proposed rules banning the use of PCB-
containing equipment from food and
feed-processing plants and storage
facilities; federally inspected meat,
poultry, and egg product
establishments; and agricultural
chemical facilities where pesticides and
fertilizer are manufactured or stored.
EPA's proposal would amend the final
PCB regulation under section 6 by
prohibiting the use of such items as
PCB-containing capacitors and
transformers in all facilities
manufacturing, processing, or storin«
fertilizers or agricultural pesticides. Tr?
rule was proposed before the court's
remand of the PCB rule (see below),
and may be affected by future actions
taken to comply with the court
mandate.
TCDD
Final control action, TCDD: TCDD
(2,3,7,8-tetrachlorodibenzo-para-dioxin)
is a highly toxic chemical found as an
unintended contaminant in other
substances, particularly phenoxy
herbicides such as 2,4,5-TCP. TCDD,
known commonly as "dioxin," is a
known carcinogen in laboratory animals,
and produces a wide range of other
adverse health effects (chloracne and
organ dysfunction, for example). Some
studies show a relationship between
exposure to dioxin and the occurrence
of these effects in some human
populations.
In March 1980, EPA proposed a rule
under section 6(a)(6) of TSCA
prohibiting Vertac, Inc., from disposirRf
certain TCDD-contaminated wastes
produced at its Jacksonville, Arkansas,
facility; the proposed rule also required
8
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other firms to notify EPA of intended
disposal of TCDD-contaminated wastes.
This rule was made immediately
effective on the date of proposal under
provisions of section 6(d). Following
completion of the required public-
comment period, the Agency
promulgated a final rule in May 1980
describing in detail the actions that
Vertac must take regarding its TCDD-
cbntaining waste. The rule also requires
anyone who intends to dispose of
wastes resulting frdm the production of
the suspended phenoxy herbicide
2,4,5-TCP (2,4,5-trichlorophenol), or
from its pesticide derivatives, to notify
EPAt least 60 days before disposal so
Agency can determine the
of the proposed disposal
method; 2,4,5-TCP is contaminated with
TCDD.
Chlorofluorocarbons
(CFCs)
Rulemaking proceeding initiated, CFCs:
Considerable scientific evidence has
been put forward that
Chlorofluorocarbons (CFCs) deplete the
atmosphere's stratospheric ozone layer,
.which protects the earth from damaging
ultraviolet radiation. In March 1978,
EPA, the Food and Drug Administration,
and the Consumer Product Safety
Commission promulgated a ban on all
nonessential uses of CFCs as aerosol
propellants. But because the use of
CFCs in various nonaerosol applications
(such as industrial solvents, plastic foam
manufacturing, and refrigeration and air
conditioning) has continued to grow,
the Agency has been investigating the
need for and possible structure of
adlA r)al controls on CFCs in the
UnsK/States.
Therefore, on October 7, 1980, EPA
published an Advance Notice of
Proposed Rulemaking (ANPR) that
discussed possible futher options for
controlling nonaerosol uses of CFCs in
the United States under the Clear Air
Act and TSCA. The ANPR discussed
several possible regulatory strategies and
requested comment from interested
parties. One of these strategies called
for limiting future CFC manufacturing
and use by restricting the total amount
of CFCs that can be produced and then
allowing market forces to distribute CFC
production among competing
applicants.
Asbestos
Proposed control action, asbestos in
schools: Scientific evidence points to
asbestos fibers as a cause of lung
damage and certain types of cancer in
humans. For many years asbestos was
widely used to insulate buildings, in
industrial and commercial products, and
in other building materials. The practice
of spraying asbestos in buildings was
virtually halted in 1973; by that time,
however, many schools and other
buildings had already been constructed
with asbestos-containing materials
(sprayed or otherwise).
The EPA program to reduce asbestos
hazards in buildings, particularly
schools, began in March 1979 with a
nationwide voluntary technical
assistance program to help States and
local school districts identify friable
(crumbling) asbestos materials in school
buildings and to take corrective actions
where necessary. Because thousands of
schools did not participate in this
program, EPA proposed a rule in
September 1980 that would require all
public and private primary and
secondary schools to identify this type
of asbestos and notify school employees
and other appropriate people of the
results of such inspections. The U.S.
Department of Education simultaneously
proposed a rule giving details on how to
obtain Federal funding of detection and
abatement programs carried out through
that Department under special
legislation; this proposed rule also would
require States to report to the
Department on results of funded
programs. An EPA rule under TSCA to
require other suitable control measures
to reduce exposure to particularly
serious asbestos situations in schools is
expected to be proposed late in 1981.
Potential asbestos substitutes and use
rulemaking proceeding: Actions by EPA
and other groups investigating the
hazards associated with exposure to
asbestos has stimulated private-sector
research to identify and develop
reasonable substitute materials and
products for asbestos. For example, in
July 1980, EPA, the Consumer Product
Safety Commission, and the Interagency
Regulatory Liaison Group sponsored a
"National Workshop on Substitutes for
Asbestos" in order to gather economic,
technical, and health-related information
about potential asbestos substitutes.
This information is being used to
develop and evaluate regulatory and
nonregulatory alternatives for reducing
human health risks associated with
exposure to asbestos. Approximately
600 representatives from industry, labor,
government, and other groups
participated in the workshop.
Although there is no known material
that can replace each or every asbestos
use, participants in this workshop group
agreed that substitutes are available for
many specific uses (the workshop
proceedings are available to the public).
EPA plans to use this information in
developing a rule to reduce
unreasonable risks from exposure to
asbestos materials in commercial and
industrial uses.
-------
Section 8: Reporting and Record-Keeping
Chemical information reporting: As
noted previously, approximately 55,000
chemicals are presently manufactured
and distributed in U.S. commerce. A
major challenge for the TSCA program
is to develop a mechanism for
identifying those chemicals likely to
damage human health or the
environment so that appropriate action
can be taken by industry or EPA.
Because there is no data base that
includes both available toxicity and
exposure data on large numbers of
these chemicals, the Agency has an
exceedingly difficult task before it. The
reporting authorities in section 8,
however, provide mechanisms for
systematically obtaining such needed
data. In 1980, the Agency devoted
substantial effort to developing
appropriate rules to implement these
authorities.
Section 8(a): This section of TSCA
permits EPA to promulgate rules under
which chemical manufacturers and/or
processors are required to maintain
records and report to the Agency the
identities and quantities of chemicals
they produce, as well as the use, the
by-products of the manufacture of those
chemicals, data on health and
environmental effects, the extent of
exposure to workers, and the manner of
disposal.
EPA's approach to implementing this
requirement is designed to be as
efficient and unburdensome as possible.
One approach, for example, involves
three levels of reporting. At the first
level, a modest amount of information
would be obtained on approximately
2,300 chemicals selected primarily for
their large production volumes and
hence potentially large exposures. Other
chemicals would be added later. After
those data were assessed, additional
data on a portion of those chemicals
would be required in a second, more
detailed level of reporting. Similarly, a
third level of reporting would provide
additional data needed on still fewer
chemicals—those identifed as most
likely to create an unreasonable risk to
health or the environment. In general,
the third level would be chemical-
specific: that is, a separate rule tailored
to the specific information needs for a
given chemical. With this information
available on the highest-priority
chemicals, EPA would work with
industry to achieve appropriate risk
reductions and to undertake regulatory
action when necessary.
Proposed rule, section 8(a): The first-
level reporting rule under section 8(a)
was proposed in February 1980. It
identifies 2,300 chemicals and calls for
available information on amounts
produced, uses, and certain exposure
data. Small manufacturers are exempt
from the rule as proposed. Work began
on the second-level and third-level
reporting rules in 1980; the second-level
rule is scheduled for proposal in 1981.
Proposed asbestos rule, section 8(a): To
better evaluate various exposures and
potential economic impacts, the Agency
is scheduled to propose a rule under
section 8(a) in early 1981 to require
miners, importers, and processors of
asbestos to report on their production,
number of employees, asbestos
releases, waste disposal, and pollution
control equipment, and to summarize
their existing monitoring data from the
Occupational Safety and Health
Administration and the Mine Safety and
Health Administration. In an effort to
reduce the overall costs of this rule, the
Agency intends to require
comprehensive reporting from only a
representative sample of the manyj
manufacturers and importers of
asbestos-containing products.
Proposed rule, section 8(a), generic
small-business exemption standards:
Generic standards are being developed
to exempt small businesses from
reporting and recordkeeping
requirements under section 8(a). A
notice relating to this activity and
announcing public meetings was
published in the Federal Register on
October 6, 1980. Under these rules,
businesses defined as "small" would be
exempt from section 8(a) requirements
unless the chemical that is
manufactured or processed is subject to
certain proposed or final TSCA actions,
including section 6 control regulations
and section 4 testing rules. The first rule
is scheduled for publication in 1981.
10
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Proposed rule, section 8(cl: In July
1980, EPA proposed a rule interpreting
section 8(c) of TSCA and establishing
procedures for maintaining records of
allegations to EPA. This section of the
Act requires manufacturers, processors,
and distributors of chemical substances
and mixtures to keep records of
significant adverse reactions to health or
the environment allegedly caused by
their chemicals. These records may be
required to be submitted to EPA under
certain circumstances. The rule is
expected to fill a large gap in
occupational health data and reveal
patterns of adverse health effects. These
patterns then can be analyzed to identify
to ^'yihemicals so that manufacturers or
EK\uJn take the necessary steps to
reduce the effects of the identified
chemicals.
Proposed rule, section 8(d): A proposed
rule to implement section 8(d) of TSCA
was published on December 31, 1979.
This section authorizes EPA to
promulgate rules requiring
manufacturers, processors, and
distributors of chemicals to submit
health and safety studies that they have
conducted or that are reasonably
ascertainable by them. Chemicals
recommended by the Interagency
Testing Committee for testing and other
chemicals selected by EPA would be
subject to the rule. Because it reaches
unpublished studies, this provision will
greatly increase the body of available
data on health and environmental
effects. The rule is scheduled for
promulgation in 1981.
Section 8(e): Section 8(e) requires
chemical manufacturers, distributors,
and processors to inform EPA
immediately if they obtain information
indicating that a chemical presents a
substantial risk of injury to health or the
environment. This reporting requirement
was self-implementing and has been in
effect since January 1977 (the effective
data of TSCA). On March 16, 1978,
EPA published a section 8(e) policy
statement providing guidance for
submitting the required information
(43 FR 11110).
Substantial-risk reporting has heightened
industry awareness of potential chemical
risks, often resulting in manufacturers,
processors, and distributors taking
action on their own to minimize
exposure to hazardous substances. To
date, EPA has received, evaluated, and
prepared status reports on 370 section
8(e) notices, 54 during FY 1980. In
addition to considering whether formal
action may be necessary under TSCA to
prevent unreasonable risks, the Agency
has referred a number of notices to
other government programs for
appropriate followup attention. Two
volumes of substantial-risk-notice status
reports have been published as part of
the TSCA Chemical Assessment Series.
(See Bibliography at end of this Report.)
11
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TSCA Section 9(d): Relationship of TSCA to
Other Federal Laws
Coordination with other chemical-control
programs: Implicit to TSCA is the need
to coordinate with other Federal
programs involved in toxic chemical
regulation, as called for under section
9(d) of the Act. Substantial progress
toward building cooperative
arrangements was made in 1980,
including signed operational procedures
with the Consumer Product Safety
Commission (CPSC) and joint
deliberations with Occupational Safety
and Health Administration (OSHA),
CPSC, and Food and Drug
Administration (FDA) staff on major
toxic-chemical issues.
Toxic Substances Priority Committee
(TSPC): The TSPC is an EPA-wide
committee comprised of Deputy
Assistant Administrators involved in
managing various statutory programs
having to do with toxic substances in
air, water, etc.; it is chaired by the
Associate Assistant Administrator for
Toxics Integration, a position located
within the Office of Pesticides and Toxic
Substances. The Committee serves as a
mechanism for coordinating consistent
and nonduplicative approaches to
chemical regulation within EPA, to
ensure that during the early stages of
problem identification, risk assessment,
and preregulatory analysis of chemicals,.
the Agency decides which program
office should take the lead and what
analytical, technical, coordinative, and
regulatory steps are appropriate. Among
the chemicals the TSPC is currently
examining are chlorinated solvents,
chlorinated dioxins, arsenic, and
benzidine.
Interagency Regulatory Liaison Group
fIRLG): The IRLG, which includes EPA,
CPSC, FDA, OSHA, and the Food
Safety and Quality Service of the
Department of Agriculture, seeks to
integrate and coordinate information and
activities on a government-wide basis, in
order to avoid duplication of effort and
promote cost-effective chemical control
programs. A number of routine, staff-
level mechanisms were maintained in
1980 to insure full participation of EPA's
TSCA activities in the ongoing IRLG
program.
LEGISLATIVE AUTHORITIES AFFECTING THE UFE CYCLE OF A CHEMICAL
/' CRCBAI
INDUSTRIAL PRODUCTS
ICSHA. FIFRAI
acoa
aa
IRCRAI
aa
aaao
CONSUMER PRODUCTS
CCPSA
FFOCA.
FFA.
FHSA.
FIFRA.
PPPAI 1
MER PRC
•\
i TSCA:
:TSCAc
• KEY-
CAA - GUAM AIM ACT HMTA
CPSA - CONSUMER PRODUCT JAffTY ACT OSHA
FfOCA - FtO. FOOD. DBL'O. & COSMtTtC ACT PPPA
FFA - FLAMMABLE FABRICS ACT NCRA
FHSA - 'EO. HAZARDOUS SUBSTANCES ACT SOW A
FIFRA - *EO. INSeCTIClt)*. FUNGlOOe. fr ROOeWTiaOB ACT TSCA
FWPCA - f€0. WATER POU.UTION CONTROl. ACT
• HAZARDOUS MATCPIAL5 TRANSPORTATION ACT
" OCCUPATIONAL SAfETY (t MtAtTM ACT
• POISON PqCVENTlON **CKAG1NO ACT
* HeSOUUCE CONSERVATION fr HSCOV6RT ACT
• 3A/E ORIMKIMd WATER ACT
* TOXIC SUSSTAMCU CONTHOi. ACT
Source: EPA Journal, July/August 1979.
12
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Section 16: Enforcement
Under section 16(a) of TSCA, EPA may
levy civil penalties for violation of several
sections of the Act. All of EPA's FY
1980 enforcement actions under section
16 involved alleged violations of the
section 6 PCB rules. EPA conducted 616
PCB compliance monitoring inspections
and filed a total of 64 civil complaints
during the fiscal year; 34 cases were
completed, and $172,130 in civil
penalties was assessed. Figures for each
Region are shown in Table 4.
The largest single penalty, $40,000, was
assessed against the Pierce Packing
Company of Billings, Montana. In 1979,
PCBs leaking from a damaged
reformer into the plant's wastewater
tment system contaminated animal
feed ingredients. The tainted feed was
then fed to poultry and livestock,
contaminating in turn meat, poultry,
eggs, soups, and bakery items.
Approximately 800,000 chickens,
3,800,000 eggs, 4,000 hogs, 74,000
bakery goods, and 800,000 pounds of
assorted animal feeds and feed
ingredients had to be destroyed to
protect the public from possible
exposure to the contaminated goods.
Criminal cases must be filed on EPA's
behalf in Federal court by the
Department of Justice. A major criminal
action was initiated under section 16(b)
of TSCA against Wes-Con, Inc., a
waste disposal company in Boise, Idaho,
for alleged improper disposal of PCBs.
On July 30, 1980, the Department of
Justice announced a grand jury
indictment against Wes-Con on the
grounds that the company allegedly
emptied PCB wastes into its own landfill
and then concealed that activity by
generating false and misleading disposal
records. The trial is scheduled to take
place in 1981.
EPA has also taken action to enforce
compliance with other TSCA
requirements, although so far there has
not been a need in these instances to
invoke section 16. The Agency
conducted 16 inspections to monitor
compliance with the interagency ban on
nonessential aerosol uses of CFCs, and
6 inspections to determine compliance
with import requirements under section
13. Also in FY 1980, the Agency
inspected 83 of 98 firms that failed to
meet the deadline for reporting identities
of existing chemicals as required under
section 8 of TSCA, to insure that the
substances reported late to the Agency
were not in fact new chemicals subject
to the PMN requirements of section 5.
In a major enforcement policy
development during FY 1980, EPA
issued a generic penalty policy that sets
forth Agency policy for applying the
statutory criteria for assessing civil
penalties under TSCA. Regulation-
specific penalty policies for PCBs, PMN,
and section 8(b) enforcement were also
issued.
Table 4. Administrative Civil Actions Taken Under Section 16 of
TSCA Through FY 1980: Complaints Issued, Cases Completed, and
Amount Assessed (by Region)
Region
I
II
III
IV
V
VI
VII
VIII
IX
X
Headquarters
Number of
complaints
issued
5
9
5
2
10
21
6
2
3
—
1
Number of
cases
completed
3
0
4
1
6
12
_
5
3
—
-
Total civil
penalty amount
assessed
$ 9,600
—
11,900
3,750
44,000
37,880
—
49,500
15,500
—
-
TOTAL
64
34
$172,130
13
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The EPA Office of Enforcement (OE)
has also been an active participant in
the overall TSCA regulations
development process. Along with this
process, OE has been shaping specific
enforcement strategies for
implementation once requirements are
promulgated. These strategies identify
and rank possible violations of the
regulation, identify the tools available for
compliance monitoring and how they
will be used, provide a formula for
determining application of inspectional
resources, and establish policy for
determining civil penalties under the
regulation. Strategies for operating
programs were implemented through the
compliance monitoring inspections
described above.
Preliminary strategies were developed
during FY 1980 along with enforcement
staff participation in TSCA rulemaking.
They include strategies for the
enforcement of the section 6 dioxin,
asbestos, and CFC production rules;
section 5 significant new use rule;
section 8(a), (c), and (d) reporting
requirements; section 12 and 13
import/export requirements; and section
4 ecological and health effects testing,
reimbursement, and testing standards
rules.
The Office of Enforcement also actively
participates in several significant
cooperative efforts. During FY 1980, OE
initiated interagency programs with the
General Services Administration and the
Department of Energy to gain
compliance with the PCB rule by Federal
facilities. Under OE leadership, the
Interagency Regulatory Liaison Group
(IRLG) implemented a referral inspection
program to improve interagency referral
of possible violations and better
coordinate the Federal response to
emergency incidents that threaten public
health or the environment. Enforcement
staff began working with the
Organization for Economic Cooperation
and Development (OECD) to foster the
international implementation of
compliance monitoring programs,
assuring international adherence to good
laboratory practices standards, and
participates on the Toxics Enforcement
Committee, an EPA interagency
committee that fosters coordination in
toxics regulation development and
enforcement strategy and policy
development.
Other TSCA enforcement activities
included entering into contracts for
inspection support, sample analysis,
policy and strategy research, and
training manuals and materials. A pilot
cooperative program with the States for
TSCA enforcement activities was also
initiated in FY 1980. In addition, a
number of outreach activities were
undertaken to involve interested
organizations in the enforcement
program, including the development of a
system for handling citizen complaints.
14
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Section 28(c): State Programs
Section 28{c) of TSCA authorizes EPA
to award grants to States for programs
to prevent or eliminate problems created
by toxic substances that EPA is unable
or unlikely to act upon under TSCA.
On August 28, 1978, EPA announced in
the Federal Register the availability of $3
million for this Federal assistance
program and provided guidance to
prospective applicants. This
announcement also described a two-
cycle award process; approximately half
the funds would be distributed each
time.
Nine states (Arkansas, California,
IJNnois, Iowa, Maryland, Michigan, New
sey. New York, and Wisconsin)
Hied for funds in the first cycle. In
April 1979, cooperative agreements
(grants requiring substantial Federal
involvement) were awarded to the five
States italicized in the previous
sentence. (See Table 5.)
" As defined in TSCA "State" means any territory or possession of
the United States.
Nine new State applications were
received in the second cycle (Colorado,
Connecticut, Delaware, Louisiana,
Michigan, Minnesota, North Carolina,
Oklahoma, Puerto Rico; Illinois applied
again in 1980). Including seven
applications held over from the first
cycle, a total of 16 State applications
were considered by EPA. In February
1980, cooperative agreements were
awarded to three States (New Jersey,
North Carolina, and Puerto Rico*).
On February 11, 1980, EPA announced
in the Federal Register the availability of
an additional $1.25 million for a third
and final cycle in this State cooperative
agreements program. Eleven States
(Illinois—which submitted two
proposals—Louisiana, Maryland,
Michigan, Minnesota, New Jersey, New
York, Ohio, Puerto Rico, Tennessee)
have applied for these funds. Once
decisions are made on these applications
early in 1981, EPA will have obligated
almost all of the $4.5 million
appropriated by the Congress for this
TSCA program.
Table 5. State Cooperative Agreements Program, 1980-1981
Project grants awarded
Cycle 1
Maryland
Department of
Health and Mental
Hygiene
Michigan
Department of
Natural Resources
New Jersey
Department of
Environmental
Protection
New York
Department of
Conservation
Wisconsin
Department of
Health and
Social Sciences
Cycle 2
New Jersey
Department of
Environmental
Protection
North Carolina
Puerto Rico
Environmental
Quality
Amount (in $)
Toxic substances registry 230,935
Critical materials program 504,500
Toxic substances investigation and integration unit; expand a 453,947
current project monitoring volatile organic compounds in air
Program to identify, characterize and plan for managing toxic 348,000
substances
Study health problems related to formaldehyde vapors from 202,947
mobile home construction materials
Study the movement, distribution and uptake of in-place 794,053
mercury; monitor emission of selected toxic substances;
assess the ecological effects of water contaminants; establish
and operate a Toxic Substances Information Resource Center;
conduct a field application study of in-vitro mutagenesis tests
Program to identify, assess and plan to control toxic 385,000
substances by profiling substances, identifying sources and
level and duration of exposure, and developing a plan to
control substances posing unreasonable risk
Develop and manage the Commonwealth's toxic substances 258,394
management strategy; expand an existing public participation/
awareness program
15
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Section 30: Litigation
Environmental Defense Fund, Inc. v.
Environmental Protection Agency (No.
79-1500, D.C. Cir.}: The Environmental
Defense Fund petitioned for review of
EPA's regulations under TSCA sections
6(e)(2) and (3) governing manufacture,
processing, distribution, and use of
polychlorinated biphenyls (PCBs). The
petition challenged three elements of the
regulation: EPA's determination that
certain commercial uses of PCBs are
"totally enclosed" and therefore exempt
from regulation under TSCA; the
limitation of applicability of the
regulation to materials containing PCBs
in concentrations greater than 50 parts
per million; and EPA's decision to permit
11 non-totally enclosed uses of PCBs.
On October_30, 1980, the Court found
that tf
lere was nolsubstantial evidence
in the record to support the first two
elements and remanded them to EPA
for further proceedings. The third
element was upheld.
Olin Corporation v. EPA (No. 79-1437,
4th Cir.): General Electric Company v.
EPA (No. 79-1816, D.C. Cir.); and
Aluminum Co. of America v. EPA (No.
79-1811, D.C. Cir.): In 1979, Olin,
General Electric, and Alcoa challenged
EPA's authority under section 6(e) of
TSCA to regulate PCBs that are created
incidentally or unintentionally as
by-products of the manufacturing
process and are then totally destroyed.
These proceedings have been stayed
until EPA reaches a decision on
exemption petitions submitted by the
three companies.
Dow Chemical Company v. Douglas
Costle (Civ. Action No. 79-581, D.
Del.): In 1979, Dow challenged EPA's
decision to include monochlorobiphenyls
in its PCB regulations, by bringing suit
in the Federal District Court of
Delaware. The Court dismissed the suit
for lack of jurisdiction and Dow
appealed. Dow Chemical Co. v. Costle
(80-1498, 3rd Cir.). Dow has obtained
a stay of its appeal pending the
outcome of an EPA administrative civil
penalty action against it for unlawful
production of the monochlorobiphenyls.
Warren County v. State of North
Carolina, et al. (No. 79-560-CIV-5,
E.D.N.C.): The Warren County
government and private citizens sued
the State of North Carolina and EPA
officials, challenging EPA's approval of a
PCB landfill located in Warren County in
July 1979. The plaintiffs have argued
that EPA was required to prepare an
environmental impact statement and
failed to do so, that the Agency
improperly waived certain EPA PCB
disposal requirements, and that such a
landfill was barred by local ordinance.
This case has not been decided.
T. Mitchell Langdon et al. v. James B.
Huntetal. (No. 86-487-CIV-5,
E.D.N.C.: In July 1980, plaintiffs sued
private defendants and State and EPA
officials for damages resulting from
private dumping of PCBs on North
Carolina roads and to prevent such
dumping in the future. Initial pleadings
are still being filed.
Natural Resources Defense Council
(NRDC) v. Costle (No. 79 CIV. 2411,
S.D.N.Y.): NRDC brought suit in 1979
to challenge EPA's implementation of
TSCA section 4(e). This section requires
EPA either to initiate a test rule or
publish its reasons for not doing so,
within one year after a chemical is
recommended for priority testing by the
Interagency Testing Committee (ITC).
EPA responded to the first two ITC
reports by stating it would not initiate
rulemaking within the year because its
evaluation of the ITC recommendations
was incomplete and basic scientific and
policy issues remained unresolved.
NRDC argued that this response did not
meet the statutory requirements.
Industry groups intervened on EPA's
behalf. In February 1980, the court ruled
in favor of NRDC and ordered EPA to
submit a compliance schedule for
responding to the backlog of ITC
recommendations. The present schedule
proposed by EPA to the court would, if
adopted, require the Agency to propose
test rules or announce decisions not to
require testing of chemicals in the first
five ITC reports by the end of 1983.
Vertac Chemical Corporation v. EPA
(No. 80-1596, 8th Cir.): In July 1980,
Vertac filed a petition for review of
EPA's rule prohibiting it from disposing
of certain wastes containing
2,3,7,8-tetrachlorodibenzo-para-dioxin
(TCDD) and requiring disposal of other
TCDD-containing waste in landfills
suited for PCB disposal. Vertac
withdrew the petition in September
1980.
Aluminum Company of America and
Northwest Alloys, Inc. v. Donald
Dubois, Douglas Costle, and
Environmental Protection Agency (No.
C801178V, W. D. Washington):
Plaintiffs sued the EPA Administrator,
the Regional Administrator for Region
X, and the Agency as a whole for
declaratory judgment thatsectionJLUa)
of TSCA does not authorize EPA to
designate EPA contractors as EPA
representatives for purposes of
performing statutory inspections and for
an injunction to prevent such
inspections. EPA has filed a motion to
dismiss the complaint for lack of
jurisdiction and because section 11
clearly authorizes EPA to designate
contractors as representatives for
purposes of inspections. The court has
not acted on EPA's motion.
16
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Other TSCA Activities
TSCA section 12(b): On December 16,
1980, EPA issued final procedural rules
for domestic chemical exporters to
submit notifications of export to EPA of
their intent to export or their actual
export of chemical substances or
mixtures subject to certain regulatory
actions under TSCA. Exporters must
submit one notice per year for each
chemical and country of import.
TSCA section 13: Section 13 of TSCA
requires the U.S. Customs Service to
refuse entry into the U.S. customs
territory of chemical substances,
mixtures, and articles containing
chemical substances or mixtures that do
ply with rules issued under
r. On December 1, 1980, the
Customs Service proposed rules to
implement this section. Concurrently,
EPA proposed a policy statement
concerning its responsibilities under
section 13. The policy statement is
scheduled to be made final in 1981.
TSCA section 20: On June 25, 1980,
EPA proposed procedural rules
concerning citizens' civil actions under
section 20 of TSCA, which authorizes
citizens to initiate suits to restrain
violations of TSCA or to compel
implementation by EPA of TSCA's
nondiscretionary authorities. The
proposed rules set forth procedures for
the statutorily required notice to the
Administrator and alleged violator prior
to filing suit. The final rule will be
promulgated early in 1981.
TSCA section 26
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The report. Supporting Innovation: A
Policy Study, was prepared by the
Center for Policy Alternatives,
Massachusetts Institute of Technology.
Its authors conclude that although the
impact of TSCA is not predictable, it is
just as likely to stimulate innovation—
such as in the development of new,
safer chemicals—as it is to discourage
innovation in other aspects of the
industry. The study recommends a
group of six management initiatives that
could be used to offset any negative
effects on innovation. As a complement
to this report, EPA has begun a 3-year
study to obtain an in-depth analysis of
innovation in the chemical industry. It
will provide detailed empirical data that
are needed before conclusive statements
about TSCA's effects can be made.
Administrator's Toxic Substances
Advisory Committee: (ATSAC): The
Administrator's Toxic Substances
Advisory Committee reflects a range of
expertise from industry, environmental,
and labor organizations, State and local
government health programs, and
medicine and law. In 1980 the
committee met five times and dealt with
many toxic substances issues including
the following: the nationwide school
asbestos removal and awareness
program; confidentiality of information
reported for the TSCA chemical
inventory; the premanufacture
notification program for new chemicals;
and the proposed TSCA testing
standards and rules.
Science Advisory Board: The EPA
Science Advisory Board (SAB) provides
principal scientific counsel to the
Administrator. Foremost among the
several SAB subcommittees that take an
interest in Agency activities under TSCA
is the Toxic Substances Subcommittee.
In FY 1980, for example, the SAB
Subcommittee on Toxic Substances
reviewed the overall TSCA program, the
proposed testing rules, the TSCA
chemical risk-assessment process, and
the technical support document for the
school asbestos rule. In the coming
year, it is anticipated that the SAB will
review the premanufacture program and
the section 8 substantial risk followup
process, in addition to section 4 testing
standards and rules. Finally, it is
expected that the SAB will review, on
its own initiative, a number of the
longer-term issues that will confront the
Agency in the area of toxic substances
control.
EPA Research Committee: The EPA
Research Committee system has been
established over the last two years to
serve as a cornerstone for program
planning in the Office of Research and
Development (ORD) and to effect a
formal liaison mechanism between ORD
and the program offices within EPA.
There are 13 Research Committees,
each of which is co-chaired by a senior
manager from ORD and a senior
manager from the corresponding
program office. EPA regional offices,
Office of Enforcement, and Office of
Planning and Management are
represented on each committee as well.
The Chemical Testing and Assessment
Research Committee plans research
activities relevant to TSCA.
International activities: EPA recognizes
the economic and social advantages of
international cooperation in chemical
testing and control: elimination of
potential nontariff trade barriers that
might result from differing national
programs and improved efficiency in
allocating limited testing and assessment
resources. In 1980, significant TSCA
program resources were devoted to
harmonizing chemical testing programs
among the 24 member nations of the
Organization for Economic Cooperation
and Development (OECD). TSCA
program staff participated in all aspects
of this OECD work, including chairing
expert groups on long-term toxicolc
and good laboratory practices and
subgroup on direct human exposure
assessment.
A major milestone was reached in May
1980 when the OECD Chemicals Group
endorsed the work of the expert groups
and achieved consensus on
approximately 44 guidelines for chemical
testing for physical/chemical properties,
degradation/accumulation
characteristics, and toxicity; principles of
good laboratory practices; a set of data
that should be generated for an initial
risk assessment before a chemical is
marketed; the need to develop an
updating mechanism to modify accepted
test guidelines as the state-of-the-art
advances; and the principle of mutual
acceptance of data, whereby data
generated by OECD methods in one
country will be accepted for purposes of
assessment in another.
18
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TSCA program staff also was involved
in developing compatible approaches to
exchanging confidential business
information and in constructing an
international glossary of key terms for
use by nations in developing control
legislation for toxic chemicals. Following
the May 1980 meeting, EPA instituted a
program to harmonize its testing
standards, developed under both TSCA
and the pesticides program, with those
developed in the OECD. As a result,
differences between like tests for
different regulatory programs have been
minimized, thereby reducing industry's
burden and allowing testing resources to
be used more efficiently.
or Problems
Implementation of section 4: EPA's
Third Annual Report on TSCA (1979)
discussed problems encountered in the
implementation of section 4 of the Act.
It also mentioned then pending litigation
brought by the Natural Resources
Defense Council with respect to the
Agency's failure to respond to the
testing recommendations of the
Interagency Testing Committee (ITC)
within the statutory period of one year,
and that the Court had found against
EPA and directed the Agency to submit
a plan for complying with section 4(e).
Since that date, the Agency has
submitted to the Court a schedule for
compliance. Affidavits accompanying
the schedule submitted to the Court set
out in detail difficulties encountered by
the Agency in its implementation of
section 4, as well as EPA efforts to
make more efficient (1) the way in
which supporting materials are
developed for test rules, and (2) internal
procedures for handling test rules and
ITC recommendations. The Agency
would be required to report to the Court
on a biannual schedule its compliance
efforts and any difficulties encountered
in meeting the schedule.
PCB remand: As a result of litigation
brought by the Environmental Defense
Fund, two major portions of the
Agency's PCB Ban Regulations were
invalidated by the U.S. Court of Appeals
for the District of Columbia Circuit. Both
the definition of "PCBs" as PCBs in
concentrations of 50 parts per million
(ppm) or greater and the designation
of intact, non-leaking PCB-containing
transformers, capacitors and
electromagnets as "totally enclosed"
uses of PCBs (and therefore exempt
from regulation) were found to be
unsupported by substantial evidence in
the rulemaking record. The impact of
the Court's October 30, 1980, decision,
when it becomes effective, is to make
applicable the broad prohibitions of
section 6(e) of TSCA; portions of the
regulation invalidated had the effect of
softening the impact of the 6(e)
prohibitions.
Since the October 1980 decision, the
Agency has been in the process of
deciding how to proceed with new
rulemaking efforts with respect to each
of these two issues. This process has
included filing multi-party motions in the
D.C. Circuit to withhold the
effectiveness of the Court's decision
pending further rulemaking or fact-
gathering efforts. Underlying these
motions to the Court are undertakings
by industry groups to supply factual
information necessary for further
rulemaking and a program of inspection
and maintenance of PCB equipment that
would have to be instituted by persons
seeking the benefit of a delay in the
effectiveness of the Court's decision.
The most serious problem presented by
the Court's decision is that the Agency
has little factual information about the
manufacture, processing and distribution
and use of PCBs in concentrations
below 50 ppm but has reason to believe
that a ban on these activities would
disrupt major industries in the United
States.
Recommendations for
Additional Legislation
No recommendations for additional
legislation were determined necessary in
1980 to carry out the purposes of
TSCA.
19
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Appendix
TSCA Publications, 19bO—
Selected Bibliography
TSCA Chemical Assessment Series
Chemical Hazard Information Profiles (CHIPs),
August 1976-August 1978. EPA 560/11-80-011.
Initial Evaluations of Substantial Risk Notices,
Section 8(e), January 1, 1977-June 30, 1979.
EPA 560/11-80-008
Initial Evaluations of Substantial Risk Notices;
Section 8(e), July 1, 1979-January 30, 1980.
EPA 560/11-80-020
Preliminary Risk Assessment: Phase I, Benzidine,
Its Congeners, and Their Derivative Dyes and
Pigments. EPA 560/11-80-019
Assessment of Testing Needs: Chlorinated
Benzenes. EPA 560/11-80-014
Assessment of Testing Needs: Acrylamide.
EPA 560/11-80-016
Assessment of Testing Needs: Chloromethane.
EPA 560/11-80-015
Support Document: Approaches to Exposure
Assessment. EPA 560/11-80-017
Toxics Integration Policy Series
State Administrative Models for Toxic Substances
Management. EPA 560/13-80-018
Toxics Information Series
Asbestos, April 1980
PCBs, June 1980
TSCA Genera/ Publications
Chemicals-in-Progress Bulletin (bimonthly)
Citizens' Guide to Toxic Substances Information
(October 1980)
Toxic Substances: A Brief Overview of the Issues
Involved April 1980
Dealing with Toxic Chemicals: A Citizen's Role
(slide show and handbook, May 1980)
TSCA: Protecting People and the Environment
from Dangerous Chemicals (July 1980)
Laws for Life (slide show, produced under a grant
to the Urban Environmental Conference,
December 1980)
Exposure (a monthly newletter produced under a
grant to the Environmental Action Foundation)
The Toxic Substances Dilemma: A Plan for Citizen
Action (produced under a grant to the National
Wildlife Federation)
Administration of the Toxic Substances Control
Act (1979) (July 1980)
Perspectives on the Top 50 Production Volume
Chemicals, July 1980. EPA 560/13-80-027
TSCA Status Report for Existing Chemicals.
EPA 560/13-80-033 (printout)
Directory of Federal Coordinating Groups for Toxic
Substances, 2nd ed. EPA 560/13-80-008
Overview of Federal Toxics Programs.
EPA 560/13-80-015
Environmental Protection
Agency—Office of Toxic
Substances
Selected Contractor Reports, FY 1980*
Acute Toxicity Testing Criteria for New Chemical
Substances. EPA 560/13-79-009 (NTIS Order »:
PB 80-111-073)
Analytical Protocols for Making a Preliminary
Assessment of Halogenated Organic Compounds
in Man and Environmental Media.
EPA 560/13-79-010 (NTIS Order #:
PB 80-162-168)
* These technical reports were prepared under contract for the
Office of Toxic Substances and were published during 1980. The
list reflects the types of research being funded by the office and
contains titled that are available through the National Technical
Information Service (NTIS). Those titles with an asterisk have
recently been sent to NTIS and can be requested by title and EPA
report number.
Arsenic: A Preliminary Materials Balance.
EPA 560/6-79-005 (NTIS Order » :
PB 80-162-217)
Asbestos-Containing Materials in School Buildings:
Bulk Sample Analysis Quality Assurance Program.
EPA 560/12-79-001 (NTIS Order*:
PB 80-217-243)
Atmospheric Reaction Products of Organic
Compounds. EPA 560/12-79-001 (NTIS Order*:
PB 80-301-384)
Cadmium and Lead Levels in Human Blood and
Kidney, A Literature Search. EPA 560/13-80-002
(NTIS Order #: PB 80-220-221)
Chemicals Identified in Human Biological Media, A
Data Base. First Annual Report, October 1979.
Volume 1, Part 1. EPA 560/13-79-011 (NTIS
Order*: PB 80-183-288)
Chemicals Identified in Human Biological Media, A
Data Base. First Annual Report, October 1979.
Volume 1, Part 2. EPA 560/13-79-011 a (NTIS
Order *: PB 80-183-296)
Determination of Pentachlorophenol and
Hexachlorobenzene Residues. EPA 560/13^W^30
(NTIS Order #: PB 80-222-672)
Economic Impact Analysis of Proposed
Identification and Notification Rule on Friable
Asbestos-Containing Materials in Schools
EPA 560/12-80-004
Economic Impact Analysis of Proposed Section 5
Notice Requirements. Parts I, II, II.
EPA 560/12-80-005, 005-A, 005-B
Economic Implications of Regulating
Chlorofluorocarbon Emissions from Nonaerosol
Applications. EPA 560/12-80-001. Flexible
Urethane Foam and Chlorofluorocarbon Emissions.
EPA 560/12-80-001-A. An Executive Briefing.
EPA 560/12-80-(J01-B. Effects on Chemical
Production. EPA 560/12^001-c
Economic Impact Analysis of Proposed Test Rule
for Chloromethane and Chlorobenzenes.
EPA 560/11-80-021 (NTIS Order*:
PB 80-215-411)
Effect of Phosphorus Control Options on Lake
Water Quality. EPA 560/11-79-011 (NTIS Order *:
PB 80-123-698)
Environmental Sources of Trichloroethylene
Exposure: Sources Contribution Factors.
EPA 560/11-80-009 (NTIS Order*:
PB 80-213-432)
Failure to Produce Arsenic Neurotoxicity in the
Rat. EPA 560/11-80-022 (NTIS Order #:
PB 80-209-505)
Formulation of a Preliminary Assessment of
Halogenated Organic Compounds in Man
Environmental Media. EPA 560/13-79-
Order »: PB 80-112-170)
20
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Investigation of Selected Potential Environmental
Contaminants: Epichlorohydrin.
EPA 560/11-80-006
Investigation of Selected Potential Environmental
Contaminants: Haloalcohols. EPA 560/11-80-004
(NTIS Order #: PB 80-197-957)
Investigation of Selected Potential Environmental
Contaminants: Styrene and Ethylbenzene.
EPA 560/11-80-018.
Materials Balance for Anilines. Level I —
Preliminary. EPA 560/13-80-013 (NTIS Order #:
PB 80-185-394)
Materials Balance for Benzene. Level I —
Preliminary. EPA 560/13-80-014 (NTIS Order #:
PB 80-185-663)
Materials Balance for Chlorobenzenes. Level I —
Preliminary. EPA 560/13-80-001 (NTIS Order*:
PB 80-173-651)
Materials Balance for Chlorophenols. Level I —
Preliminary. EPA 560/13-80-004 (NTIS Order #:
80-185-960)
erials Balance for 1,2-Dichloroethane. Level I —
Himinary. EPA 560/13-80-002 (NTIS Order #:
I 80-177-132)
Materials Balance for Methyl Chloroform. Level II.
EPA 560/13-80-003 (NTIS Order #:
PB 80-175-730)
Methodology for Estimating Direct Exposure to
New Chemical Substances. EPA 560/13-79-008
(NTIS Order #: PB 80-102-262)
Organic Solvent Use Study. Final Report.
EPA 560/12-79-002 (NTIS Order »:
PB 80-301-342)
Proceedings of the EPA Workshop on the
Environmental Scoring of Chemicals.
EPA 560/11-80-010 (NTIS Order #:
PB 80-194-640)
Residential Monomers in Acrylic and Modacrylic
Fibers and Fabrics. Final Report.
EPA 560/11-80-003 (NTIS Order It:
PB 80-129-166)
Sampling and Analysis of Selected Toxic
Substances. Task I: Acrylamide.
EPA 560/13-79-013 (NTIS Order »:
PB 80-128-150)
Sampling and Analysis of Selected Toxic
Substances. Task I: Polybrominated Biphenyls in
Air and Soil at Two User Sites.
EPA 560/13-80-005 (NTIS Order #:
PB 80-176-373)
Structure-Reactivity Coorelations for
Environmental Reactions. EPA 560/11-79-012
(NTIS Order #: PB 80-110-323)
Supporting Innovation: A Policy Study.
EPA 560/12-80-002
Test Methods for Definition of Effects of Toxic
Substances on Behavior and Neuromotor
Function. EPA 560/11-79-010 (NTIS Order f:
PB 80-109-101)
Toxic Substances Control Act Chemical
Substances Inventory: Cumulative Supplement,
July 1980. Computer Tape EPA 560/13-80-025
(NTIS Order #: PB 80-220-007)
Volatile Corrosion Inhibitors and Boiler Water
Additives—Potential for Nitrosamine Formation.
EPA 560/11-80-023 (NTIS Order #:
PB 80-221-195)
Selected Federal Register
Notices, FY 1980
February 11, 1980. Notice of Availability of Funds
for Cooperative Agreements with States.
45 FR 9248
February 25, 1980. Premanufacture Notices;
Status Report for January 1980. 45 FR 12295
February 29, 1980. Prohibition of All New
Replacement Equipment and Machinery
Containing Liquid Polychlorinated Biphenyls
(PCBs). 45 FR 13471-12473, 13476
February 29, 1980. General Recordkeeping and
Reporting Requirement: Preliminary Assessment
Information. 45 FR 13646-13676
March 5, 1980. Polychlorinated Biphenyls (PCBs);
Request for Information on PCB Transformers.
45 FR 14247
March 6, 1980. Fifth Report on the Interagency
Testing Committee to the Administrator,
Environmental Protection Agency: Receipt of the
Report and Request for Comments Regarding
Priority of Chemicals; Extension of Comment
Period. 45 FR 14649
March 11, 1980. Tetrachlorodibenzo-p-dioxin;
Prohibition of Disposal. 45 FR 15547, 14492-15601
March 21, 1980. Amendment to Inventory
Reporting Requirements; Final Rule. 45 FR 18374
March 26, 1980. Premanufacture Notices; Status
Report for February 1980. 45 FR 19609
April 17, 1980. Organization for Economic
Cooperation and Development (OECD) Chemical
Program; Final Reports on Testing Guidelines;
Notice of Availability. 45 FR 26129
April 18, 1980. Pesticide Programs; Guidelines for
Registering Pesticides in the United States;
Proposed Good Laboratory Practices for
Toxicology Testing. 45 FR 26373
April 18, 190. Inventory Reporting; Statement of
Policy, Late Submissions Under Section 8(b) of
TSCA. 45 FR 26452
April 21, 1980. Premanufacture Notices, Status
Report of March 1980. 45 FR 26815
April 28, 1980. Pesticides and Toxic Substances
General Recordkeeping and Reporting
Requirement: Preliminary Assessment of
Information; Notice of Public Meetings for 8(a)
Level Proposed Rule. 45 FR 28176
May 1, 1980. Polychlorinated Biphenyls (PCBs),
Expiration of the Open Border Policy for PCB
Disposal; Notice, 45 FR 29115
May 9, 1980. Polychlorinated Biphenyls (PCBs)
Manufacturing, Processing, Distribution in
Commerce, and Use Prohibitions; Proposed
Restrictions on Use at Agricultural Pesticides and
Fertilizer Facilities. 45 FR 30989
May 19, 1980. Storage and Disposal of Waste
Material; Prohibition of Disposal of
Tetrachlorodibenzo-p-dioxin: Final Rule.
45 FR 32655
May 28, 1980. TSCA Chemical Substances
Inventory; Availability of Chemical Production
Information Tape. 45 FR 35396
May 28, 1980. Sixth Report of the Interagency
Testing Committee to the Administrator,
Environmental Protection Agency; Request for
Comments Regarding Priority List of Chemicals.
45 FR 35897
June 3, 1980. Toxic Substances Control; Approval
of Test Marketing Exemption. 45 FR 37886
June 10, 1980. PMN and Review; Economic
Impact. 45 FR 39450
June 19, 1980. Premanufacture Notices, Status
Report of May 1980. 45 FR 41498
June 25, 1980. Prior Notice of Citizen Suit;
Proposed Procedural Regulation. Proposed Rule.
45 FR 43148
June 30, 1980. Approval of Test Marketing
Exemption. 45 FR 43863
June 30, 1980. Reporting Requirements for
Manufacturers and Processors of Fully
Halogenated Chlorofluoroalkanes and Fully
Halogenated Chlorofluoroalkanes; Recodification.
Final Rute. 45 FR 43721
July 11, 1980. Part III. Records and Reports of
Allegations of Significant Adverse Reactions to
Health or the Environment; Proposed Rule.
45 FR 47008
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July 18, 1980. Part V. Acrylamide; Response to
the Interagency Testing Committee; Exemption
from Test Rules, Proposed Statement of Policy
and Procedures; Chloromethane and Chlorinated
Benzenes Proposed Test Rule, Proposed Health
Effects Standards Amended. Notice and Requests
for Comments. 45 FR 48510
July 23, 1980. Carbamic Acid, Bis(Methoxymethyl)
Isopropyl Ester; Denial of Test Marketing
Exemption. 45 FR 49160
July 28, 1980. Premanufacture Notices, Status for
June 1980. 45 FR 49974
July 29, 1980. Availability of TSCA Revised
Inventory. Notice of Availability. Transfer of TSCA
Premanufacture Notification Information to
Contractor; Data Transfer. Certain Chemicals,
Premanufacture Notice. 45 FR 50644, 50420, 50418
July 31, 1980. Approval of Test Marketing
Premanufacture Exemption. 45 FR 50930
August 8, 1980. Office of Pesticides and Toxic
Substances; Approval of Test Marketing
Exemption. 45 FR 52911
August 11, 1980. Premanufacture Information;
Access by Subcontractor and Consultants.
45 FR 53212
August 12, 1980. Approval of Test Marketing
Exemption. 45 FR 53562
August 12, 1980. Part VI Interagency Working
Group on a Hazardous Substances Export Policy.
45 FR 53754
August 15, 1980. Premanufacture Review
Program; Proposed Processor Requirement.
45 FR 54642
August 25, 1980. Toxics Integration Information
Series and Toxics Integration Policy Series; Notice
of Availabiity. 45 FR 56432
August 26, 1980. Premanufacture Notices, Status
for July 1980. 45 FR 56909
September 3, 1980. Allegations of Significant
Adverse Reactions; Public Meetings, Notice of
Meeting Related to Proposed Rule. 45 FR 58383
September 10, 1980. Guidelines for the
Assessment of Civil Penalties Under Section 16 of
the TSCA, PCB Penalty Policy. 45 FR 59769
September 17, 1980. Department of Education
(Part V) Asbestos Detection and Control: Local
Educational Agencies; Asbestos Detection and
State Plan: State Educational Agencies.
45 FR 61950
September 17, 1980. Department of Education
(Part VI), Friable Asbestos-Containing Materials in
Schools; Proposed Identification and Notification.
45 FR 61966
September 23, 1980. Premanufacture Notification
Requirements and Review Procedures; Clarification
of Importer Reporting Responsibilities.
45 FR 63006
September 24, 190. Adipic Acid, . . .
Premanufacture Notices. 45 FR 63343
September 25, 1980. IRLG Reproductive Toxicity
Risk Assessment Task Group, Outline of Work
Plan and Request for Comments. FR 45 63553
October 2, 1980. Toxic Substances;
Premanufacture Information Access by Contractor
and Subcontractor. 45 FR 65299
October 6, 1980. Manufacturers and Processors of
Chemical Substances; Notice of Intent to Develop
Exemption Standards. 45 FR 66180
October 7, 1980. Ozone-Depleting
Chlorofluorocarbons; Proposed Production
Restriction. 45 FR 66726
October 14, 1980. Navy Publication and Printing
Office and the Environmental Protection Agency;
Interagency Agreement to Microfiche Certain
Confidential Documents. 45 FR 67757
October 15, 1980. Exemptions from Test Rules:
Proposed Statement of Policy and Procedures,
Correction. 45 FR 68410
October 24, 190. Alkanedioic Acid Mixed
Alkanolamines Salt; Premanufacture Notice:
Extension of Review Period. 45 FR 70557
October 24, 1980. Submission of Notice of
Manufacture or Importation of Polybrominated
Biphenyls (PBBs) and Tris; Final Rules.
45 FR 70728
October 28, 1980. Administrator's Toxic Substance
Advisory Committee; Meeting. 45 FR 71414
October 28, 1980. Polychlorinated Biphenyls in
Food, Feed, Agricultural Pesticides and Fertilizer
Facilities. 45 FR 71364
October 30, 1980. Chemical To Be Reviewed by
the TSCA Interagency Testing Committee.
45 FR 71862
November 3, 1980. Approval of Test Marketing
Exemption. 45 FR 72775
November 7, 1980. Toxic Substances
Premanufacture Notification Requirements and
Review Procedures; Statement of Revised Interim
Policy. 45 FR 74378
November 13, 1980. Premanufacture Notification
Requirements and Review Procedures; Availability
of Proposed Economic Impact and Draft
Regulatory Analyses. 45 FR 74945
November 13, 1980.
1,2-Substituted-1,1,2,2-Tetramethyldisilane;
Approval of Test Marketing Exemption.
45 FR 74992
November 17, 1980. Toxics Integration Information
Series and Toxics Integration Policy Series; Notice
of Availability. 45 FR 75759
November 21, 1980. Proposed Environmental
Standards; and Standards for Physical, Chemical,
Persistence, and Ecological Effects Testing.
45 FR 77332
November 25, 1980. Receipt of Seventh RepoJ
the Interagency Testing Committee to the
Administrator, Request for Comments on Priority
List of Chemicals. 45 FR 78482
November 26, 1980. N-Methanesulfonyl-p-
toluenesulfonamide; Determination of Significant
New Uses for a Chemical Substance. 45 FR 78970
November 26, 1980. Part 721-Significant New
Chemical Use. 45 FR 78977
November 26, 1980. Modified Polyester Based on
Carbomonocyclic Anhydride Alkenediols;
Premanufacture Exemption Application.
45 FR 78796
December 1, 1980. Chemical Imports and Exports;
Proposed Policy Statement for Chemical
Substances; Solicitation of Public Comment.
45 FR 79726
December 2, 1980. Prohibition of Polychlorinated
Biphenyls (PCBs) and PCB-Containing Equipment
or Machinery and Liquid PCBs in Federally
Inspected Meat Establishments and Egg Product
Plants; Extension of Comment Period.
45 FR 79819
December 16, 1980. Chemical Imports and
Exports; Notification of Export. 45 FR 82844
*U S GOVERNMENT PRINTING OFFICE: 1981 344-945/8509
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