United States
Environmental Protection
Agency
Washington, DC
20460
January 1982
Toxic Substances
vvEPA
Toxic Substances
Control Act (TSCA)
Report to Congress
for Rscal Year 1981
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27416
TSCA REPORT TO CONGRESS
FOR FISCAL YEAR 1981
, January, 1982
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF TOXIC SUBSTANCES
401 M. Street, S.W.
Washington, D.C. 20460
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CONTENTS
Introduction 1
Reporting on TSCA Section
4 5
5 8
6 12
9(d) 17
16 19
26 (a) 23
28 (c) 24
Reporting on
Litigation 27
Other TSCA Activities 29
Sections 12(b) and 13 29
Major Problems 29
Recommendations for Additional Legislation 29
Note: This report covers activities in Fiscal Year 1981
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INTRODUCTION
This fourth annual report to Congress summarizes progress made
during Fiscal Year 1981 by the Environmental Protection Agency
(EPA) in implementing the Toxic Substances Control Act (Public Law
94-469, 94th Congress). It fulfills the congressional reporting
requirements of sections 9(d)/ 28(c), and 30 of the Act.
Implementing the Toxic Substances Control Act (TSCA) is the
responsibility of the EPA Office of Toxic Substances. Overall
responsibility for the TSCA program continues to be that of the
Assistant Administrator for Pesticides and Toxic Substances, a
position that reports directly to the Administrator.
TSCA took effect on January 1, 1977. Programs now exist under
the Act to gather available information about the toxicity of
particular chemicals and the extent to which people and the
environment are exposed to them, to bring about industry testing
where existing data are inadequate, to assess whether particular
chemicals cause unreasonable risks to humans or the environment,
and to institute appropriate control actions after carefully
weighing the risk against the benefits provided by particular
chemicals to the nation's economic and social well-being.
To help ensure informed decisionmaking by the government, TSCA
gives EPA authority to gather basic information on chemical risks
from the manufacturers and processors of such substances. The
law also enables EPA to require companies to test chemicals for
toxic effects and stipulates that companies are to submit to EPA
certain specified information on 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 unreasonable risks at any stage in a chemical's life-
cycle: in manufacturing, processing, distribution in commerce,
use, and/or disposal.
In assigning these authorities to EPA in order to implement TSCA,
Congress intended that prudence be exercised. EPA's actions
under TSCA acknowledge the significant role that the chemical
industry plays in the economy of the United States: in 1980, for
example, the industry's annual sales approached $162 billion and
generated an annual trade surplus of about $12 billion; the
production of chemicals and allied products accounted for roughly
5 percent of the Gross National Product; and the industry
employed about 1.1 million people.
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Research done by the Agency shows that chemical production is not
evenly distributed among the 11,000 establishments involved in
the manufacture and processing of chemicals. The five largest
companies in terms of chemical sales, account for 22 percent of
industry sales, and the fifty largest account for more than 60
percent. However, most chemical firms are small—53 percent
employ fewer than 100 people.
In creating TSCA Congress recognized that too often in the past
the hazards of particular chemicals were discerned only after
extensive harm had occurred to human health and the environ-
ment. Asbestos is a well-known example of such a hazard. In
other instances adverse effects are suspected but have not been
proven to the ex.tent necessary for regulatory decisionmaking.
The thrust of TSCA is to make it the industry's responsibility to
develop missing data where there is a bona fide indication of
potential risk.
The Agency's basic approach in implementing TSCA has been to use
the Act's various provisions to stimulate better and more timely
industry assessments of chemical risks. This approach should
lead to more rapid and cost-effective achievement of the Agency's
main 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, the industry has
voluntarily undertaken risk-reduction measures such as improving
in-plant emission controls or has instituted toxicity testing.
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Implementation of TSCA, by Section of the Law,
FY 1981
Section of Law Description
4(a)
4(a)
4(a)
4(b)
4(b)
5(a)
5(a)
5(a)
6(a)
6(e)
Testing for health and
environmental.effects:
nitrobenzene
Testing for health and
environmental effects:
dichloromethane
Testing for health and
environmental effects:
1,1,1-trichloroethane
Action
Proposed
rule
Proposed
rule
Proposed
rule
Test standards for Proposed
physical, chemical, and rule
environmental persistence
characteristics
Good laboratory practices Proposed
standards for physical, rule
chemical, and environ-
mental persistence charac-
teristics and for ecologi-
cal effects testing
Revised interim policy,
premanufacture notifi-
cation
Draft regulatory
analysis; proposed
economic impact
analysis
Chemical-specific SNUR
CFC production
limitations
PCB Manufacturing, proc-
essing, distribution in
commerce, and use
prohibitions; proposed
restrictions on use of
PCBs at agricultural
pesticide and fertilizer
facilities; abeyance of
proposed rule amendment
Interim
policy
Proposed
rule
Proposed
rule
Advance
notice of
proposed
rulemaking
(ANPR)
Proposed
rule
amendment;
notice of
abeyance
Date
6/5/81
(46 FR 30300)
6/5/81
(46 FR 30300)
6/5/81
(46 FR 30300)
11/21/80
(45 FR 77332)
11/21/80
(45 FR 77353)
11/7/80
(45 FR 74378)
11/13/80
(45 FR 74945)
11/26/80
(45 FR 78970)
10/7/80
(45 FR 66726)
5/6/81
(46 FR 25411)
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6(e)
6(e)
6(e)
6(e)
6(e)
6(e)
12(b)
13
21
Use of PCBs in
electrical equipment
Use of PCBs in
electrical equipment
Use of PCBs in
electrical equipment
PCBs: Court order
regarding PCBs in
concentrations below
50 ppm
PCBs: Manufacturing of
PCBs in concentrations
below 50 ppm; possible
exclusion from manu-
facturing prohibition
Manufacturing,
processing, distribution
in commerce, and use
prohibitions; PCBs in
concentrations below
50 ppm
Export notifications
to foreign governments
Customs entry policy
PCBs: Denial of
citizens' petition
Rule- 3/10/81
related (46 FR 16069)
court order
and enforce-
ment notice
Advance
notice of
proposed
rulemaking
(ANPR)
Rule-
related
notice
Rule-
related
notice
Advance
notice of
proposed
rulemaking
(ANPR)
Advance
notice of
proposed
rulemaking
(ANPR)
Final rule
Proposed
policy
Proposed
rule-
related
notice
3/10/81
(46 FR 16096)
5/20/81
(46 FR 27614)
5/20/81
(46 FR 27615)
5/20/81
(46 FR 27617)
5/20/81
(46 FR 27619)
12/16/80
(45 FR 82844)
12/1/80
(45 FR 79726)
12/4/80
(45 FR 80320)
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TSCA SECTION 4: TESTING OP CHEMICAL SUBSTANCES AND MIXTURES
Section 4 of TSCA gives EPA authority to require manufacturers or
processors of chemicals to test designated substances for toxic
effects. EPA exercises this authority only when it can make
certain statutory findings about the substance involved. These
required findings are that a chemical may present an unreasonable
risk; that there are insufficient data available with which to
perform a reasoned risk assessment; and that testing is necessary
to provide such data. A test rule also may be based on an Agency
finding of substantial production and exposure to humans or the
environment, in addition to findings of insufficient data and the
need for testing.
Testing methodology requirements: Testing required by rule is to
be performed according to prescribed standards developed by EPA
in consultation with other government agencies, nongovernment
scientific experts, industry, foreign governments, and the
general public. The test standards are to prescribe the health
and environmental effects, as well as information relating to
toxicity and other characteristics, for which test data are to be
developed. In addition, to the extent necessary to assure
reliable and adequate data, EPA is authorized to prescribe the
test .methodology to be employed and other requirements. Such
requirements will assure uniformly reliable and consistent
results from a variety of domestic and foreign sources of data.
Generic test standards; The Agency had previously indicated its
intention to impose relatively rigid generic testing methodology
requirements that were to be incorporated in rules for testing
individual chemicals. Under this approach, EPA published
proposals for health effects testing on May 9, 1979 (44 PR
27334), and on July 26, 1979 (44 PR 44054), and proposals for
physical, chemical, and environmental persistence characteristics
testing on November 21, 1980 (45 PR 77332). Since publishing
these proposals. Agency staff have developed additional test
methodology guidelines for mutagenicity, neurotoxicity,
ecological effects, and physical, chemical, and environmental
persistence characteristics.
Significant effort has been made to harmonize TSCA testing
methodologies with the protocols of other U.S. Government
agencies in the Interagency Regulatory Liaison Group (IRLG)* and
with the International Testing Standards developed by the 24
*The IRLG member agencies were EPA, the Consumer Product Safety
Commission (CPSC), the Food and Drug Administration (FDA), the
Occupational Safety and Health Administration (OSHA), and the
Food Safety Quality Service (FSQS) of the Department of
Agriculture. The four-year interagency agreement establishing
the IRLG expired on September 26, 1981.
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member nations of the Organization for Economic Cooperation and
Development (OECD).
New approach; Generic methodology guidelines. EPA has recently
decided to issue test methodologies as informal guidelines rather
than as generic methodology requirements. These guidelines will
be one of several sources from which the Agency may choose to
adopt methodological requirements for testing individual
chemicals on a rule-by-rule basis. This approach affords the
Agency the flexibility to modify the requirements to fit
different chemicals. In so doing it allows the Agency to
determine the most cost-effective methodology and gives testing
laboratories an opportunity to make full use of their scientific
judgment in suggesting appropriate methodologies. The test
methodology guidelines also would serve as guidance for voluntary
testing conducted by the chemical industry.
Good laboratory practices; In addition to test methodologies,
the Agency also has proposed Good Laboratory Practice (GLP)
standards for health effects testing (44 FR 27362) and for
physical, chemical, persistence, and ecological effects testing
(45 FR 77353). The final GLP standards, which delineate proper
procedures for conducting laboratory testing, will be promulgated
as regulatory requirements, as originally proposed. After a
review of the evidence compiled by the Food and Drug
Administration (FDA) and EPA in their laboratory inspection/
auditing programs, EPA determined that implementation of the GLP
protocols as regulations is justified to provide increased
quality and integrity in the test data that will be submitted to
the Agency under TSCA.
Proposed testing rules; On June 5, 1981, EPA proposed the second
set of TSCA testing rules under authority of Section 4(a) of the
Act. The proposed rules would require testing for the health and
environmental effects of nitrobenzene, dichloromethane, and
1,1,1-trichloroethane, all of which had been recommended for
priority testing by the Interagency Testing Committee (ITC).*
Nitrobenzene; The proposed nitrobenzene rule would require
testing for teratogencicity and reproductive effects based on the
finding that nitrobenzene may present an unreasonable risk of
injury to human health. The proposed rule would also require
testing for certain environmental effects and for adsorption to
*The ITC was created by TSCA to recommend chemicals to EPA for
priority consideration for test rules under Section 4(a) of the
Act. Its member agencies are EPA, the Occupational Safety and
Health Administration (OSHA), the Council on Environmental
Quality (CEQ), the National Institute for Occupational Safety and
Health (NIOSH), the National Cancer Institute (NCI), the National
Science Foundation (NSF), the National Institute of Environmental
Health Sciences (NIEHS), and 'the Department of Commerce.
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soils. The basis for proposing environmental testing is the
finding that nitrobenzene is produced in substantial quantities
and is released into the environment in substantial amounts. EPA
also found that currently there are insufficient data available
with which it can evaluate the environmental effects of that
release and the listed health effects of human exposure ascribed
to the substance.
Dichloromethane; The proposed dichloromethane rule would require
testing for certain health effects and certain environmental
effects for which there currently are insufficient data avail-
able. The proposal is based on the finding that dichloromethane
is produced in substantial quantities, that there is substantial
human exposure to this substance, and that there is substantial
release of this substance to the environment.
1,1,1-Trichloroethane; The proposed 1,1,1-trichloroethane rule
wouldrequiretesting for teratogencity and for certain
environmental effects for which there are currently insufficient
data available. The proposal is based on the finding that
1,1,1-trichloroethane is produced in substantial quantities, that
substantial numbers of persons are exposed to this substance, and
that there is substantial release of this substance to the
environment.
Testing Costs; Because the 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 during fiscal
year 1981.
Testing rule schedule: The Interagency Testing Committee (ITC)
has submitted a total of eight priority lists to EPA; 26
individual chemicals and 19 chemical groups or categories have
been identified by the Committee for test rule consideration. In
1979 the Natural Resources Defense Council (NRDC) challenged
EPA's responses to the first two sets of recommendations by the
ITC. On February 4, 1980, the U.S. District 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 issued a final order in January 1981. Under the
schedule EPA is required to respond to a total of 11 ITC
recommendations during calendar year 1981.
In response to this lawsuit and to EPA's own concerns about the
Section 4 program, the Agency reevaluated and substantially
modified its approach to evaluating ITC recommendations and
developing Section 4 test rules. In 1981 this contributed to
more efficient and timely test rule development. As part of this
new procedure, EPA held "scoping" conferences in March and July
1981 on the subject of the ITC's seventh and eighth sets of
recommendations. These conferences provide an early opportunity
for input from the industry, academia, and others in order to
sharpen the Agency's focus on the issues it needs to consider.
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TSCA SECTION 5: NOTIFICATION AND REVIEW OF NEW CHEMICALS
Premanufacture notification; Section 5 of TSCA requires that any
person who intends to manufacture (or import) a new chemical
substance for commercial purposes in the United States must
submit a notice to EPA at least 90 days before commencing
manufacture or import of the substance. A "new chemical
substance" is any chemical substance that does not appear in the
TSCA Chemical Substances Inventory. The notice must contain
information specified in Section 5(d), including any information
derived from testing for health and environmental effects. .
Under Section 5(a)(2), the Administrator is authorized to issue a
Significant New Use Rule (SNUR) that requires notification
through the PMN process by anyone who proposes to manufacture or
process a subject chemical for certain "new" uses defined in the
rule.
A person who wants to manufacture a new chemical substance for
test marketing purposes can submit a test market exemption
application (TMEA) under Section 5(h)(l) of the Act. The Agency
must either grant or deny the TMEA within 45 days and publish
notice of this action in the Federal Register. The submitter
must show that the manufacturing, processing/ distribution in
commerce, use, or disposal of the TMEA substance or any
combination of such activities will not present an unreasonable
risk of injury to health or the environment under the test
marketing conditions specified in the application.
Premanufacture Notification (PMN) rules; On January 10, 1979,
EPA publishedin the Federal Register proposed rules and notice
forms for the PMN program. In response to comments, the Agency
reproposed portions of the rules and a revised form on
October 16, 1979. The reproposal designated the rules as "major"
rules under Executive Order 12044 and announced that the
appropriate regulatory and economic analyses would be conducted
and published for comment. The methodology for the economic
impact analysis was published in the Federal Register on June 10,
1980, and the regulatory and economic impact analyses were
published for comment on November 13, 1980. A public meeting was
held on April 8, 1981, the close of the 120-day comment period.
The two analyses are being revised to reflect the comments
received. In addition to the October 1979 reproposal, the Agency
published a clarification of the definition of the term
"importer" in the Federal Register on September 23, 1980. In
August 1980 the Agency proposed that processors of certain exempt
substances submit notices prior to processing for a nonexempt
purpose. Until final rules are promulgated, the new-chemical
review program will operate under the Interim Guidance published
in the Federal Register on May 15, 1979, and November 7, 1980.
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Under Section 5(h)(4) EPA may exempt from any PMN requirements by
rule new chemical substances for which the manufacturing,
processing, distribution in commerce, use, or disposal will not
present an unreasonable risk of injury to health or the
environment. The Agency is working on several exemptions to the
premanufacture notice requirements in response to applications
filed by industry. The first application for an exemption under
Section 5(h)(4) of the Act was filed by Polaroid Corporation in
April 1980. Additional petitions for exemptions were filed by
the Chemical Manufacturers Association (CMA) in May 1981, the
Synthetic Organic Chemical Manufacturers Association (SOCMA) in
June 1981, the Dyes Environmental and Toxicology Organization
(DETO) in July 1981, and Ashland Chemical Company in August
1981. Late in 1981 EPA proposed a rule to exempt new chemicals
used in or for instant photographic film articles from
premanufacture notice requirements. The proposal is in response
to the Polaroid petition.
New-chemical review process: Following the receipt of a notice
by the Agency, review of the new chemical substance is carried
out in three phases: initial review, detailed review, and an
action phase. The initial review identifies concerns that may be
raised for health and environmental effects and environmental ,
release of the substance. A substance that may pose an
unreasonable risk and that requires further study is the focus of
a detailed review. The Agency conducts a detailed review of all
information that it can reasonably obtain regarding the concerns
about the substance. If sufficient data are not available on the
specific new chemical, information on closely related existing
chemicals is used. The detailed review identifies data gaps and
recommends further testing that may be appropriate. For good
cause, TSCA authorizes in Section 5(c) an extension of the 90-day
review period for up to an additional 90 days, to permit
completion of the detailed assessment. In FY 81, the review
period was extended for three such cases.
When concerns raised are substantiated by a detailed review or
when insufficient information is available to make a reasoned
evaluation and there may be an unreasonable risk of injury to
health or the environment or there may be significant exposure,
the Agency can take action to control the PMN substance. EPA can
propose an order under Section 5(e) or 5(f); however, other
alternatives are open to the Agency. As discussed earlier, the
Agency may, for example, promulgate a significant New Use Rule
under Section 5(a)(2) for the subject new chemical for certain
"new" uses defined in the rule. Or EPA may issue a follow-up
reporting requirement under Section 8(a) to ensure notification
should a manufacturer propose to produce the chemical in excess
of a given production volume or for specified uses. In many
cases the Agency and the submitter can work together to develop
voluntary controls for reducing exposure that would mitigate
Agency concerns.
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Section 5(e) and 5(f) orders; A Section 5(e) order is issued to
limit or to ban the manufacture/ processing, distcibution in
commerce, use, or disposal of a new chemical substance pending
development of additional information. In 1981 work was begun on
two Section 5(e) orders; both PMN substances were direct type
blue fabric dye chemicals. The PMNs for these two substances
were withdrawn by the submitters in anticipation of.the 5(e)
orders being served.
A Section 5(f) order is issued to prohibit the manufacture,
processing, or distribution in commerce of a new chemical
substance that has been shown to present an unreasonable risk;
under Section 5(f) EPA may also issue a proposed rule, effective
immediately, to limit the manufacture, processing, or
distribution in commerce of the substance. No Agency action
under these authorities in Section 5(f) was required in 1981.
Test market exemption applications (TMEAs); In an application
for a test marketing exemption the submitter must show that there
will be no unreasonable risk-of injury to health or the
environment caused by test marketing the substance. Based on
information provided in the submitter's application, the Agency
must either grant or deny the exemption within the 45-day time
period prescribed by the Act. In FY 1981 the Agency received 40
TMEAs.
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Section 5 PMN Review Summary/ October I, 1980 - September 30, 1981
Description Total
Total valid PMNs submitted 581
PMNs for which a 5(c) extension was issued 3
PMNs withdrawn 2
5(e) orders initiated 2
5(e) orders issued 0
Total valid TMEAs 40
TMEAs granted 38
TMEAs denied 2
TMEAs withdrawn 0
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TSCA Section 6: REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES
AND MIXTURES
/•
Chemical control; Under Section 6 of TSCA, EPA has the authority
to prohibit or limit the manufacture, processing, distribution in
commerce, use, and/or disposal of chemicals that are 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 1981 EPA undertook activities
intended to lead to control actions against polychlorinated
biphenyls (PCBs), 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD),
asbestos, and chlorofluorocarbons (CFCs).
Polychlorinated Biphenyls (PCBs)
Final control action, PCBs; In TSCA Congress singled out PCBs
for both immediate regulation and phased withdrawal from the
market; the only exceptions to this occur if EPA grants
authorizations or exemptions for specific activities. PCBs are
of concern because tests on laboratory animals show that PCBs
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.
Control of 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.
In FY 1981 EPA was ordered by the Court to develop new regulations
governing the use of PCBs in electrical equipment and to formulate
a plan for dealing with PCBs in low concentrations. EPA has
issued Advance Notices of Proposed Rulemaking (ANPRs) on three
subjects: (1) the use of PCBs in electrical equipment, (2) the
exclusion from regulation of PCBs manufactured under circumstances
that involve little or no risk, and (3), the manufacture, processing,
distribution in commerce, and use of PCBs in low concentrations.
The Edison Electric Institute, the Chemical Manufacturers
Association, and the Dry Color Manufacturers Association are
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performing studies on PCBs. These studies and the public
comments on the ANPRS will form the factual record EPA will use
to accomplish its Court-ordered tasks.
On May 9, 1980, because of the serious potential consequences to
public health from food accidentally contaminated with PCBs, the
EPA, the Department of Agriculture, and the 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 fertilizers are manufactured or stored.
EPA's proposal would have amended the final PCB regulation under
Section 6 by prohibiting the use of such items as PCB-containing
capacitors and transformers in all facilities manufacturing, pro-
cessing, or storing fertilizers or agricultural pesticides. On
May 6, 1981, that proposed rule was placed in abeyance, pending
the outcome of new rulemaking that will be conducted to resolve
the EOF case.
TCDD
Final control action, TCDD; TCDD (which refers to 2,3,7,8-
tetrachlorodibenzo-para-dioxin, one of several possible isomers
of polychlorinated dioxins) is a highly toxic chemical found as
an unintended contaminant in other substances, particularly the
phenoxy herbicide 2,4,5-T (2,4,5-trichlorophenoxy acetic acid).
TCDD, familiar as dioxin, is a known carcinogen in laboratory
anLnals that also 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 latter effects in some human populations.
In May 1980 EPA promulgated a rule under Section 6(a)(6) of
TSCA prohibiting Vertac, Inc., from disposing of certain TCDD-
contaminated wastes produced before May 1980 at its Jacksonville,
Arkansas, facility. Those wastes must remain stored at the
site. The rule allows Vertac to dispose of wastes that were
produced after May 1980, which are less contaminated with TCDD,
in landfills approved for PCB disposal. In September 1981 EPA's
Region VI office determined that a landfill in Calcasieu,
*
These agencies, through a cooperative effort headed by the TSCA
Industry Assistance Office, disseminated -about 20,000 hazard-
alert pamphlets to food and feed establishments to promote swift
precautionary measures.
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Louisiana, did not meet PCB disposal requirements, thereby
preventing vertac from disposing of its post-May 1980 wastes
there.
The rule also requires anyone who intends to dispose of wastes
resulting from the production of 2,4,5-trichlorophenol or from
its pesticide derivatives, to notify EPA at least 60 days before
disposal so that the Agency can determine the adequacy of the
proposed disposal method. These products generally cover most
substances contaminated with TCDD. EPA is considering whether
to replace the storage and notification provisions of the rule
with specific requirements for the long-term disposal of all
TCDD-contaminated wastes and plans to publish an ANPR late in
1981 to solicit information on currently used disposal methods.
The ANPR will also solicit input from Vertac, Inc., that
describes Vertac's preferred method for disposing of its pre-May
1980 wastes.
The Agency also is evaluating the combustion emissions, including
TCDD? from several industries. In FY 1981 results of tests at
two waste combustion facilities revealed and quantified TCDD in
stack emissions from one of the plants. Four coal-burning power
plants also were sampled. Analytical results from these are
expected early in 1982.
Asbestos
Proposed control action, asbestos in schools; Scientific
evidence points to asbestos fibers as a cause of lung damage and
a rare mesothelioma type of lung cancer in humans. For many
years asbestos was widely used to insulate buildings, in
industrial and commercial products, and in other 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.
The EPA program to reduce asbestos hazards in 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 schools and to take
corrective action 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.
Since 1979 and concurrently with rulemaking activities, EPA has
sponsored an active technical assistance program to States and
to local school districts. A series of asbestos documents has
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been published that provides guidance to school districts
attempting to comply with the proposed identification and
notification rule. The documents deal with a variety of issues,
including inspection, assessment, and sampling and analysis of
asbestos-containing materials. In addition, technical assistance
is available through a toll-free telephone number. Finally, EPA
has sponsored an on-going quality assurance program to address
the problems associated with laboratory analysis of asbestos-
containing materials.
Rulemaking proceeding, asbestos use; As part of a continuing
investigation of the hazards associated with exposure to
asbestos, EPA will complete in late 1981 a contract study to
identify and evaluate substitutes for asbestos. Although there
is no known material that can replace every asbestos use,
substitutes are available for many specific uses. EPA plans to
use this information to assess the magnitude of asbestos
exposure from commercial and industrial uses and, if necessary,
to design measures to reduce those exposures. Action under
TSCA is being coordinated with EPA actions under other statutes
and with the actions of other Federal agencies.
Chlorofluorocarbons (CFCs)
Rulemaking proceeding, CFCs; In response to concerns raised by
the findings of the 1979 National Academy of Sciences' assessment
of the CFC/ozone depletion issue, EPA issued an Advance Notice of
Proposed Rulemaking (ANPR) in October 1980 to gather information
about the validity of the ozone depletion theory, the appropriate-
ness of restricting the use of CFCs, and possible alternative
courses of action for the Agency. The Agency received more than
2,000 comments. A preliminary analysis of those comments led the
Agency to conclude that many of the issues raised deserve additional
study.
EPA has initiated further analysis of the CFC issue. Staff are
working closely with experts in and out of government studying
the unresolved scientific questions and economic implications of
CFC emission reductions. Scientists at other Federal agencies,
as well as in academia and industry, are evaluating the potential
effects of CFCs, other halocarbons, carbon dioxide, and nitrogen
oxide on the stratosphere. Laboratory measurements, atmospheric
observations, and theoretic studies (modeling) are being used.
Current central estimates of various models indicate that present
CFC-11 and CFC-12 emissions, if continued, may result in 5 to 10
percent ozone depletion; due to uncertainties in stratospheric
chemistry and physics, however, the estimate may be in error by
a factor of 2 in either direction (from one half to double the
central estimates). Contractors to EPA are performing further
economic and technical analysis of various methods for reducing
CFC emissions in nonaerosol applications.
15
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EPA contracted with the National Academy of Sciences (NAS) for
an assessment of the most recent scientific information regarding
stratospheric ozone changes and the resultant effects. The
Agency anticipates receiving the NAS report by March 1982.
EPA has been involved in international cooperation on the CFC issue
in scientific research, monitoring efforts, and assessments, such
as the work of the United Nations Environmental Program's
Coordinating Committee on the Ozone Layer (CCOL), the World
Meteorological Organization, various other international scientific
organizations, and several bilateral research projects. In
addition, the United States is a member of the 24-nation
Organization for Economic Cooperation and Development (OECD),
which has been a forum for exchanging information on science,
technology, economics, and regulatory aspects of CFCs. In view
of the global implications of the CFC issue, it is important that
the Agency continue to work with other countries, and that EPA
consider domestic CFC efforts in the context of the work of the
international community.
In addition, EPA staff are continuing to process requests for
exemptions to the 1978 rule, which banned nonessential aerosol
uses of CFCs. Exemption requests are evaluated on the basis of
the availability of substitutes, the economic significance of
the product, the environmental and health impacts of the aerosol
product and its substitutes, and the effect on the quality of
life if the product or a reasonable substitute were unavailable.
In 1981 the Agency proposed to grant exemption requests for the
aerosol use of CFCs as a propellant for substances used to
lubricate pharmaceutical rotary press punches and as the
propellant for spinerette-release agents used in the production
of man-made fibers. The Agency also granted a temporary exemption
for the use of CFCs in automatic pesticide dispensing systems
for long-term storage of flue-cured tobacco, pending a review of
a request for a permanent exemption. EPA denied two applications
for exemptions: for CFC used in spray adhesives and in fog
machines used in theatrical productions. Four exemption requests
are now under investigation by the Agency.
16
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TSCA SECTION 9(d): .RELATIONSHIP OF TSCA TO OTHER FEDERAL LAWS
Coordination with other chemical programs; Section 9(d) of TSCA
requires coordination and consultation with other Federal
programs involved in toxic chemical regulation to achieve maximum
effectiveness of TSCA and minimum duplication of effort and
purpose.
Toxic Substances Priorities Committee (TSPC);* The TSPC is an
EPA-wide Committee of office directors charged with resolving
those toxic substances problems that cannot be dealt with by a
single program office. The Committee is responsible for
promoting consistency and minimizing duplication in Agency
activities, ranging from identifying major toxic substances
problems to performing risk assessments and developing regu-
lations. The TSPC has focused its attention on developing an
Agencywide risk assessment of toluene and an Agencywide strategy
for assessing and controlling, where appropriate, six chlorinated
organic chemicals used as metal degreasing solvents. The sol-
vents strategy has involved more than one major analysis,
including overall exposures, health and ecological hazards, risk
assessments, chemical substitutes, cost-effectiveness of past
controls, regulatory effectiveness, and potential control
options. The final solvents strategy will be completed in FY
1982 and will be evaluated as a model for future Agencywide
chemical/industry work groups.
Interagency Regulatory Liaison Group (IRLG);** The IRLG, which
included EPA,the Consumer Product Safety Commission (CPSC), the
Food and Drug Administration (FDA), the Occupational Safety and
Health Administration (OSHA), and the Food Safety Quality Service
(FSQS) of the Department of Agriculture, sought to integrate and
coordinate information and activities on a governmentwide basis,
in order to avoid duplication of effort and promote cost-effective
chemical control programs. Among its activities in FY 81, the
IRLG established a task group on DEHP (diethylhexyl phthalate);
sponsored with the National Toxicology Program a throe-day
symposium on phthalates; and worked with the Departments of
Energy and Housing and Urban Development to develop a multimedia
risk assessment of formaldehyde. EPA also coordinated the
development of PCB regulations with the FDA and the FSQS.
*The role of the TSPC is being re-examined as part of an Agency-
wide evaluation of interprogram committees and may, therefore,
change in FY 1982.
**The four-year interagency agreement establishing the IRLG
expired on September 26, 1981. The Agency is now represented at
the Regulatory Work Group on Science and Technology chaired by
the White House Office of Science and Technology.
17
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Relationship of TSCA to international activities; The EPA has
been a full and regular partner in extensive international
consultations and negotiations in the Chemicals Program of the
24-nation Organization for Economic Cooperation and Development
(OECD) during the development of the Agency's chemical testing
and other requirements under TSCA. The Agency places a high
priority on these activities because of benefits both for
international chemical trade and for more effective health and
environmental protection.
U.S. experts, along with those of other OECD member states, have
worked since 1977 to develop chemical testing guidelines and good
laboratory practices, as well as a set of data that should be
developed for new chemicals prior to marketing.
The OECD Council took formal action on parts of the Chemicals
Program work in May 1981, adopting a Decision on the Principle of
Mutual Acceptance of Data, which incorporates the Test Guidelines
and Good Laboratory Practices.
EPA is also involved in a number of other cooperative
international forums aimed at exchanging knowledge and building
mutual understanding on chemical safety issues. Among these are
the United Nations Environment Program's (UNEP) International
Registry of Potentially Toxic Chemicals (IRPTC), the World Health
Organization's (WHO) International Program on Chemical Safety,
and the WHO Project on Assessment of Human Exposure to Pollutants
through Biological Monitoring.
18
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TSCA SECTION 16: ENFORCEMENT
Under Section 16 of TSCA, EPA may levy either civil or criminal
penalties for a violation of several sections of the Act.
Specific enforcement strategies for implementing regulations have
been developed by the Agency. These strategies identify and rank
possible violations of a particular regulation, identify the
tools available for compliance monitoring and how they will be
used, provide a formula for determining application of inspection
resources, and establish policy for determining civil penalties
under the regulation.
Violations of Section 6; in FY 1981 all enforcement actions
under Section 16 involved alleged violations of the Section 6 PCB
rules. EPA conducted 1,000 PCB compliance monitoring inspections
and filed a total of 115 civil complaints during the fiscal year;
66 cases were completed, and $537,895 in civil penalties was
assessed. Figures for each Region appear in the table.
The largest single penalty, $61,000, was assessed against
Consolidated Edison Company of Long Island City, New York. In
March 1980, 3,400 gallons of PCB-contaminated oil spilled from
the facility into the East River. Other violations at the
facility included improper storage and marking of large
quantities of PCBs and failure to maintain complete records.
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, a grand jury indictment was issued
against Wes-Con charging the company with emptying PCB wastes
into its own landfill and then concealing that activity by
generating false and misleading disposal records. Subsequently,
a jury found the company guilty of improper disposal of PCBs, and
on January 16, 1981, the company was fined $3,500.
On May 22, 1981, a Federal jury in North Carolina found Robert E.
Ward, of the Ward Transformer Company, guilty of aiding in the
illegal dumping of thousands of gallons of transformer oil
contaminated with PCB on roadsides in that State in the summer of
1978. In June the Court sentenced Ward to 2 1/2 years in prison
and levied a fine of $200,000. Another person involved in the
case was sentenced to 1 ^ years in prison and two others were
placed on 5 years' probation.
Compliance with other TSCA requirements; EPA has also taken
action to enforce compliance with other TSCA requirements,
although so far there has not been a need to invoke Section 16.
The Agency conducted 46 inspections to monitor compliance with
the interagency ban on nonessential aerosol uses of CFCs and two
inspections to determine compliance with import requirements
under Section 13. Also in FY 1981 the Agency inspected five
19
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firms that had failed to meet the deadline for reporting
identities of existing chemicals as required under Section 8(b)
of TSCA. The inspections were held to ensure that the substances
reported late to the Agency were not in fact new chemicals
subject to the PMN requirements of Section 5. There were 10
inspections and compliance monitoring reviews of facilities
subject to Section 5 requirements.
During FY 1981 strategies were developed for the enforcement of
Section 8 PPB/TRIS and Section 6 dioxin rules, as well as for the
PCB interim measures program. Preliminary enforcement response
policies were developed for CFCs and dioxin.
20
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Administrative Civil Actions Taken Under Section 16 of TSCA Complaints Issued, Cases Completed,
and Amounts Assessed (by Region)t
Region
I
II
III
IV
V
VI
VII
VIII
IX
X
Total No.
complaints
issued
FY 79-81
6
51
11
9
41
40
16
14
11
6
No . com-
plaints
issued in
FY 1981
1
36
3
7
23
15
10
8
6
6
Headquarters 1
TOTAL
206
115
Total
No. cases
completed
FY 79-81
6
27
8
3
13
27
8
10
6
0
0
108
No. cases
completed*
in FY 1981
3
20
3
2
9
14
8
5
2
-
—
66
Total No.
of cases
pending
0
26
3
6
28
12
8
4
5
6
1
99
Total civil
penalty amount
assessed (in $)
in FY 81
20,500
265,350
30,200
19,775
71,320
62,600
26,150
34,000
8,000
-
—
$537,895
Total civil
penalty amount
assessed (in $)
FY 79-81
30,100
340,750
45,700
23,525
102,820
104,960
26,150
83,500
26,300
-
—
$783,805
tAll actions taken involved alleged violations of Section 6, PCB rules.
*Includes carry-over from FY 1979 and 1980.
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During FY 1981 the EPA participated in interagency programs with
the General Services Administration and the Department of Energy
to gain compliance with the PCB rule by Federal facilities. Led
by pPA the Jnteragency Regulatory Liaison Group (IRLG)
implemented, a, j?$ferral inspection program to improve interagency
referral of poafible violations and to coordinate better the
Federal response to emergency incidents that threaten public
health or the environment. In addition, the Agency worked with
the Organization for Economic Cooperation and Development (OECD)
to foster the international implementation of compliance
monitoring programs and assure international adherence to good
laboratory practices standards.
Other TSCA enforcement activities in FY 1981 included entering
into contraajbg for inspection support, sample analysis, policy
and strategy "research, and training manuals and materials.
Finally, EPA offered pilot cooperative enforcement agreements to
five states for the support of TSCA enforcement activities.
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TSCA SECTION 26(a): INDUSTRY ASSISTANCE OFFICE
The Industry Assistance Office (IAO); Section 26(a) of TSCA
requires the availability of a source of technical and other
nonfinancial assistance to the regulated community. The Industry
Assistance Office (IAO) is the contact point for communication
between that community and the Office of Toxic Substances. To
assist the chemical industry's understanding of the Act's
implementation requirements, IAO provides both an information
telephone service and the bimonthly TSCA Chemicals-in-Progress
Bulletin. In addition, IAO is directing a pilot field
consultancy program that is now operating in Chicago and parts of
New Jersey to assist small businesses with their premanufacture
notices. This program will be evaluated for possible expansion
to other areas of the country.
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TSCA SECTION 28(c): STATE PROGRAMS
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
on 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. The announcement also described a two-cycle award
process; approximately half the funds were to be distributed each
time.
Nine states (Arkansas, California, Illinois, Iowa, Maryland,
Michigan, New Jersey, New York, and Wisconsin) applied for funds
in the first cycle. In April 1979 cooperative agreements (grants
requiring substantial Federal involvement) were made with
Maryland, Michigan, New Jersey, New York, and Wisconsin. Ten
State applications were received in the second cycle (Colorado,
Connecticut, Delaware, Louisiana, Michigan, Minnesota, North
Carolina, Oklahoma, Puerto Rico,* and Illinois). Including seven
applications held over from the first cycle, a total of 16 State
applications were considered by EPA. In February 1980 coopera-
tive agreements were made with 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 the program. Eleven States (Illinois—which submitted
two proposals—Louisiana, Maryland, Michigan, Minnesota, New
Jersey, New York, Ohio, Puerto Rico, and Tennessee) applied for
funds.
In March 1981 cooperative agreements were made with four States
(Illinois, Maryland, Michigan, and Ohio). Ohio decided not to
proceed with its project and returned its TSCA funds.
The funds Congress appropriated for this program have been
awarded. No State-cooperative-agreement projects have yet been
completed.
*As defined by TSCA, "State" includes any U.S. territory or
possession.
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State
Cooperative Agreements Program,
Project Grants Awarded ~~~
Amount (in $)
Cycle I
(April 1979)
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
(February 1980)
NEW JERSEY
Department of
Environmental
Protection
NORTH CAROLINA
Office of the
Governor
Toxic substances registry
Critical materials program
Toxic substances investigation
and integration unit; expand a
current project monitoring
volatile organic compounds in
air
Program to identify,
characterize, and plan for
managing toxic substances
Study health problems related
to formaldehyde vapors from
mobile home construction
materials
Study the movement, distri-
bution, and uptake of in-place
mercury; monitor emissions 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 sub-
stances by profiling sub-
stances, identifying sources
and level and duration of
exposure, and developing a
plan to control substances
posing unreasonable risk
230,935
504,500
453,947
348,000
202,947
794,053
385,000
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PUERTO RICO Develop and manage the 258,394
Environmental Commonwealth's toxic
Quality Board substances management
strategy; expand an existing
public participation/awareness
program
Cycle 3
(March 1981)
475,626
ILLINOIS Develop an integrated
Department of voluntary system for detecting
Public Health morbidity and mortality
resulting from exposure to
toxic substances
MARYLAND Develop a program to assure 100,000
Department of the safe and effective
Health and Mental containment of toxic
Hygiene substances in storage tanks
MICHIGAN Develop an interdepartmental 532,258
Department of risk assessment process
Natural Resources
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LITIGATION
Environmental Defense Fund, Inc. v. Environmental Protection
Agency (No. 79-1580, D.C. Cir.).In 1979 the Environmental
Defense Fund (EOF) petitioned for review of EPA's regulations
under TSCA Sections 6(e)(2) and (3) governing the 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 (ppm); and EPA's decision to permit 11 non-totally
enclosed uses of PCBs. On October 30, 1980, the Court found that
there was no substantial evidence in the record to support the
first two elements and remanded them to EPA for further
proceedings. The third element was upheld.
The effect of this decision would have made continued use of
PCB-containing transformers, capacitors, and electromagnets and
the continued manufacture, processing, and use of PCBs below 50
ppm violations of Section 6(e) of TSCA. PCBs are widely used in
electrical equipment and are incidentally generated in a variety
of industrial processes. Because of the substantial difficulties
this decision would have caused for industry, the EPA, EDF, and
industry intervenors petitioned the Court to stay its mandate to
permit EPA to conduct a new rulemaking. The Court issued orders
on February 12, and April 13, 1981, that stayed issuance of the
mandate; adopted a plan and established a schedule for EPA to
conduct new rulemaking; required persons continuing to use
electrical equipment with PCBs in certain concentrations to
adhere to the terms of an interim inspection and reporting
program; and required Edison Electric Institute (EEI), an
intervenor, to conduct a study on the use of PCBs in electrical
equipment and to submit the study to EPA to aid in developing the
new rules. The orders established the following schedules for
new rulemaking: by July 1982 EPA must promulgate a final rule on
the use of PCBs in electrical equipment; by October 1982 EPA must
promulgate a final rule with respect to excluding "controlled
wastes" and "closed manufacturing processes" from the statutory
bans; and by March 1982 EPA must advise the Court of plans for
further action with respect to the regulation of other PCBs in
low concentrations.
i
EDF has petitioned the Court under Section 19(d) of TSCA for an
award of attorneys' fees. EDF's request of $156,600 was computed
by (1) multiplying by the prevailing market rate for attorney's
fees the time spent by EDF attorneys in preparing the case and
participating in negotiations in petitioning the Court to stay
its mandate, and (2) multiplying the result of the foregoing
computation by an adjustment based on the difficulties in
prosecuting the litigation and the quality of representation.
EPA has opposed the award for lack of adequate supporting
•7*7
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documentation or, alternatively/ argues that the award be
substantially reduced from that requested by EOF.
Aluminum Company of America v. Du Bois (No. C80-1178V; W.D.
Wash.). Plaintiffs sued EPA, the EPA Administrator, and the
Regional Administrator for Region X for a declaratory judgment
that Section ll(a) 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 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 found that EPA is authorized to use non-Agency
employees as contractors to conduct investigations under Section
11 of TSCA. ALCOA is appealing the decision before the Ninth
Circuit.
There is nothing further to report on the following cases, which
were noted in last year's report:
Olin Corporation v. EPA (No. 79-1437, 4th Cir. )
General Electric Company v. EPA (No. 79-1816, D.C. Cir.)
Aluminum Company of America v. EPA (No. 79-1811, D.C. Cir.)
Warren County v. State of North Carolina, et al.
(No. 79-560-CIV-5, E.D.N.C.)
T. Mitchell Langdon et al. v. James B. Hunt et al.
(No. 86-487-CIV-5, E.D.N.C.)
Dow Chemical Company v. Douglas Costle (Civ. Action No.
79-581, D. Del.)
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OTHER TSCA ACTIVITIES
TSCA Section 12(b); Section 12(b) requires persons exporting or
intending to export a chemical substance or mixture that has been
subject to certain actions under sections 4, 5, 6, and 7 of TSCA
to notify EPA. The Agency in turn must notify the importing
country of the export and EPA's regulatory action. On December
16, 1980, the Agency promulgated the final Section 12(b) rule to
govern submission of these notices to EPA. On July 21, 1981, EPA
published a notice clarifying which exports of asbestos are
subject to the notification requirements. The requirements of
Section 12(b) currently apply to CFCs, PCBs, N-methanesulfonyl-p-
toluene-sulfonamide, asbestos, and TCDD.
TSCA Section 13; Section 13 requires the Secretary of the
Treasury to refuse entry of any chemical substance, mixture, or
article into the United States if it violates TS_CA or a rule
under TSCA. EPA is consulting with the United States Customs
Service on the development of a rule to implement Section 13.
The Customs Service proposed a rule in late 1980. EPA
simultaneously proposed a policy statement regarding imports
under TSCA.
MAJOR PROBLEMS
Recent reviews of the Environmental Protection Agency's
administrative procedures suggest that the implementation of the
Toxic Substances Control Act may be adversely affecting
technological innovation in the chemical industry. Such an
impact may be particularly likely to occur under Section 5,
premanufacture review notification for new chemicals, and under
Section 4, testing of chemicals. The new Administration will be
taking a hard look at the administrative procedures to see if, in
fact, hinderances to innovation do exist. If a positive
determination is made, the Administration will be analyzing new
ways to protect health and the environment while enhancing
chemical development and research. For example, in response to
the Vice President's Task Force on Regulatory Reform, the Agency
is seeking to identify new chemicals that do not present an
unreasonable risk, so that they* can be e.xempted from all or part
of the PMN requirements.
RECOMMENDATIONS FOR ADDITIONAL LEGISLATION
No recommendations for additional legislation are determined to
be necessary in FY 1982 to implement TSCA.
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