United States January 1984
Environmental Protection
Agency
Washington DC 20460
&EPA Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1983
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Toxic Substances
Control Act (TSCA)
Report to
Congress
for Fiscal Year 1983
Prepared by:
U. S. Environmental Protection Agency
Washington, DC 20460
January, 1984
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Contents
1 Introduction : 1
2 Highlights of the Year
Program Implementation 3
International Activities 5
Regulatory Improvement 6
Enforcement 7
3 New Chemicals
Program Status 9
PMN Rule 10
Exemptions 11
Follow-Up program 11
4 Existing Chemicals
Program Status 13
Existing Chemicals Control 15
Information Activities 18
5 Chemical Testing
Program Status 21
Test Guidelines 22
Reimbursement of Testing Costs 22
Quality of Data 23
6 Enforcement 24
7 Litigation 27
8 State Programs 32
Tables
1. Summary of New Chemical Actions
2. Summary of Existing Chemical Actions
2A. Detail Summary on National Toxicology Program Studies and
CHIPs
3. EPA Response to Interagency Testing Committee (ITC)
4. Administrative Civil Actions Taken Under Section 16 of TSCA
5. TSCA Section 28
Appendices.
Appendix A - Summary/Guide to Information Required by
Congress (Section 9(d), 28(c) and 30)
Appendix B - Major FY'83 TSCA Actions
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1
Introduction
This sixth annual report to Congress summarizes progress
made by the Environmental Protection Agency (EPA) in
implementing the Toxic Substances Control Act (TSCA)
during Fiscal Year 1983. This report fulfills the
Congressional reporting requirements of sections 9(d),
28(c) and 30, in addition to providing highlights of
significant environmental programs and Agency progress
in achieving environmental quality.
The Toxic Substances Control Act (TSCA) took effect on
January 1, 1977. Since that time, the Office of Toxic
Substances (OTS) under the direction of the Assistant
Administrator for the Office of Pesticides and Toxic
Substances (OPTS) has had the responsibility for
developing and implementing the statutory requirements
of the Act as well as the discretionary authorities included
by the Congress to enhance its effectiveness.
TSCA is a complex piece of legislation with a scope
comprehensive enough to encompass the many gaps in
the eighteen existing public health and environmental
laws. Through TSCA, the EPA seeks to prevent or reduce
the chance of injury to the public and the environment
from harmful chemicals. TSCA provides EPA with the
authority to evaluate and regulate if necessary at any
stage in a chemical's life cycle including manufacture,
process, commercial distribution, use and disposal.
Programs now exist under the Act to evaluate chemicals
prior to commercialization through a process of
premanufacture notification for new chemicals and new
uses of existing chemicals (Section 5); to evaluate
existing chemicals (after commercialization) by requiring
testing under Section 4 and reporting of additional data
under Section 8; and to control unreasonable risks of
existing chemicals through regulatory action under
Sections 6 and 7.
While TSCA authorizes many regulatory approaches in
response to harmful chemicals, it is wholly consistent
with the concept of adequately controlling problems while
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imposing minimal burdens (Executive Order 12291, the
Regulatory Flexibility Act, and the Paperwork Reduction
Act). Specifically, TSCA mandates that its authorities not
impede or create unnecessary economic barriers to
technological innovation and that EPA use reason and
prudence in carrying out its responsibilities. To achieve a
balanced regulatory approach, the Act requires a weighing
of risks against the benefits provided by particular
chemicals or classes of chemicals.
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2
Highlights of the Year
Program Fiscal Year 1983 saw significant achievements in all areas
Implements- °f TSCA implementation. While the Agency met all
tion statutory requirements of the Toxic Substances Control
Act and all court ordered deadlines, a major
accomplishment in itself, it also focused on developing
and implementing discretionary, yet critical, sections of
the Act.
This was the first year in which the Agency saw the
results of its negotiated testing program under Section 4
of TSCA. This program, initiated in 1980, sought to
minimize the time and resources needed to develop test
data for chemicals identified as having potential adverse
effects. EPA, working with the affected manufacturers and
industry consortia, developed a negotiating process to
abbreviate the formal rulemaking process of Section 4.
While the integrity of the data and its development is
maintained, the time of development is shortened
substantially, providing data more rapidly for,risk
evaluation. These negotiated testing agreements (NTAs)
are made in lieu of formal testing rules whenever
agreement can be reached.
In FY'83, the Agency received nearly 200 test studies
performed on chemicals subject to past testing actions
under these Negotiated Testing Agreements. These
incoming data are a key component in the risk
identification activities carried out under TSCA's existing
chemicals program and would not yet be available save
for the negotiated process.
FY'83 was also a year of major changes in the Agency's
approach to existing chemical control. In FY'83, an OTS
Existing Chemicals Task Force developed and put into
place a project management system for evaluation and
decisionmaking on risks from existing chemicals. During
the year more than 60 chemicals were brought under
evaluation, selected on the basis of Section 8(e) notices,
Section 4 test results, and NTP test results.
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Nearly half of these 60 were identified for further
analysis over the next year and five were chosen as
candidates for possible regulatory action. With the
exception of the promulgation of the PCB rules, which are
specifically mandated by Section 6(e) of TSCA, this
represents more actions than taken in all previous years
since TSCA was enacted.
On August 22, 1983, the Agency promulgated the final
Section 8(c) rule requiring manufacturers and processors
to maintain records of alleged significant adverse
reactions to health or the environment. When a chemical
worker, consumer or a resident living nearby a plant
alleges an adverse reaction to a chemical, mixture,
process article or plant effluent, this rule establishes the
mechanism for the retention of such allegations. Worker
health allegations must be retained for 30 years and all
others for five years. The Agency will inspect and require
reporting of such records. This rule will help the Agency
identify previously unknown chemical hazards as well as
to reveal patterns of effects that might otherwise go
unnoticed for long periods of time.
In May 1983, a final premanufacture notice (PMN) rule
was issued. The effective date of the rule was October
1983. Prior to this time, the PMN process was conducted
under an interim policy with proposed rules. The final
PMN rule establishes standardized PMN reporting and
recordkeeping requirements and provides consistent
requirements for new chemical review. The important
benefits of the rule include 1) a standardized reporting
form and 2) the ability to declare individual PMN
submissions incomplete. As a result EPA is able to
address more effectively the increasing number of PMNs
it receives.
In 1983 EPA developed more Section 5(e) orders than
in all other years to date. These orders are aggressive
responses by EPA to the PMN submitter that additional
data must be submitted or developed prior to
commercialization. "Consent 5(e) order", a new approach
to the problem of insufficient data submission, is an
agreement between EPA and the submitter to allow
commercialization with tight controls until data are
developed, thereby encouraging innovation while ensuring
protection of the public health and the environment.
In FY'83 EPA issued the first proposed significant new
use rules (SNUR); three for new chemicals and one for an
existing chemical. The SNUR authority of TSCA (Section
5(a)(2)) provides the Agency with the ability to require
additional review and evaluation of a chemical for which
production, use or exposure patterns have changed
significantly. Before introducing a designated changed use
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pattern, the SNUR would require the manufacturer to
submit additional data and information to allow he Agency
to re-evaluate the potential risks associated with the
chemical. The implementation of this authority is a critical
step towards continuing chemical control after
commercialization.
These highlights present an overview of major TSCA
implementation steps. Many additional activities within
EPA, and the Office of Toxic Substances, will be
presented in more detail in specific programmatic sections
of this report.
International Since the passage of TSCA, EPA has actively participated
Activities 'n a ran9e °f international programs centered on toxic -
substances control. EPA participation in these programs is
critical as toxic substance issues often transcend national
bouhdaries. International chemical regulation can affect
international trade and the economic stability of various
chemical industries. Exchange of data and assessment
techniques can offer significant benefits to all nations.
EPA contributes strongly to the success of these
programs through the sharing of its technical expertise
and its broad experience in chemical review and control.
EPA's participation also enhances the effectiveness of its
own operations and its role in chemical control in the
United States.
Perhaps the most visible and successful of EPA's
international efforts continues to be its participation in the
Chemicals Program of the Organization for Economic
Cooperation and Development (OECD), an international
group composed of the major industrial trading nations.
Because national laws regulating hazardous chemicals can
create barriers to international trade in chemicals, the
OECD began a program in 1977 to harmonize its member
countries' programs regarding toxic substances control.
The OECD Chemicals Program focuses primarily on the
elimination or reduction of barriers to international trade in
chemicals and on the sharing of technical expertise.
During 1983 EPA participated actively in the OECD test
guidelines development program. EPA has the lead for
developing four new OECD test guidelines as well as
participating in the OECD Test Guideline Update Panel
and expert workgroups. The development of additional
OECD test guidelines will improve the quality of data
developed worldwide and will reduce the need for
unnessary, duplicative testing. Also, FY'83 was the first
year of a new international initiative in existing chemicals.
This existing chemical initiative focuses on identifying and
harmonizing the needs of member countries with respect
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to chemical testing. As part of this activity, EPA chairs the
Switchboard Project, a referral system which will improve
access by member countries to unpublished information.
In addition, EPA experts made significant contributions to
the development of a common format for existing
chemical reviews. This common format will facilitate the
exchange of information and the development of methods
for identifying chemicals on which data are currently
inadequate. The U.S. has also developed a notification
program under Section 12 of TSCA, which provides for
notification to foreign countries regarding the hazards
associated with chemicals regulated under TSCA.
Also, EPA participates in several United Nations'
programs, such as the International Register of Potentially
Toxic Chemicals (IRPTC) of the U.N. Environmental
Program (UNEP). The basic objective of IRPTC is to
promote more efficient use of national and international
resources in the evaluation and control of chemical risks.
EPA supports the IRPTC by notifying the program of
chemical incidents, completed preliminary risk
assessments and proposed regulatory actions and by
responding to foreign inquiries relayed through IRPTC.
EPA also participates in another UNEP project to develop
a Global Ozone Protection Convention. Once adopted, this
convention will provide for better coordination and greater
cooperation among nations in regulation, research,
monitoring, and information exchange concerning
stratospheric pollution and potential modification of the
ozone layer. EPA is also active with the U.N. World
Meteorological Organization and the Chemical
Manufacturers Association (CMA) Fluorocarbon Program
Panel in a joint international effort to improve global
monitoring of the earth's ozone layer. Additionally, EPA
has a working agreement with the Federal Republic of
Germany to exchange technical information in the area of
exposure modeling.
Regulatory The major focus of OTS' activities in pursuing regulatory
Improvement improvements has been to maximize public input into its
decisionmaking in order to minimize the burden of
regulation wherever appropriate. EPA is continuing to
develop ways to ensure public health and environmental
protection while minimizing the adverse impact on
innovation and the economic costs of regulatory controls.
This is accomplished through such activities as negotiated
rulemaking, development of Agency wide strategies for
chemical control and public outreach activities.
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In addition to the negotiated testing agreements
mentioned earlier, EPA is actively developing plans for
negotiated rulemaking. A negotiated process such as the
negotiated testing agreements has enabled the Agency to
develop regulations more rapidly, achieving greater public
input in the beginning and less adversarial conflict during
the process. A recent project demonstrates the benefits
of this approach. The most recent PCB regulations were
negotiated between the affected industry and two
environmental groups. This proposal was submitted to the
Agency and will provide the core of final rulemaking. In
addition, toluenediamine (TDA), a chemical under
assessment for TSCA rulemaking, has been identified by
the Agency as another candidate for negotiation under
this new program.
The Agency is also working toward coordinating i
strategies for chemical control with all EPA programs.
While TSCA enables EPA to utilize various control options,
the Agency is encouraging intra-office input into risk
assessment activities and risk management alternatives.
The evaluation of hexachlorobenzene (HCB) is a good
example of this comprehensive approach.
EPA has found that effective public outreach and
education programs have often helped minimize the
adverse impact of Agency regulations. Providing accurate
and timely information to the public and industry allows
for a better understanding of the rule or regulation and
encourages compliance. Toward this end, OTS has
created a task force to develop an education program for
those affected by the Section 8(c) rule. OTS is also
currently developing a strong program to interact with the
Regions and States on information sharing on chemicals
of mutual concern. EPA has held two well-attended public
meetings to explain the final PMN reporting rule and the
final Section 8(c) rule. Each of these meetings were
attended by over 200 people.
Enforcement Under Section 16 of TSCA, EPA may levy either civil or
criminal penalties for a violation of certain sections of the
Act.
In FY'83, most of the civil enforcement actions under
Section 16 involved alleged violations of the PCB rules.
The Agency filed a total of 285 civil complaints during the
fiscal year as a result of PCB inspections. Also in FY'83,
the Agency took its first dioxin enforcement action under
TSCA concerning disposal requirements. In FY'83, the
Justice Department, on behalf of EPA, obtained a criminal
conviction for illegal interstate transportation of PCBs and
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PCB containers and for improper disposal of PCB material.
FY'83 also saw the first imposition of major fines for PMN
violations.
In addition, the Agency initiated inspection programs to
monitor compliance with Negotiated Testing Agreements,
and inspections continued under the Section 6
asbestos-in-schools rule.
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3
New Chemicals
Program In Section 5 of TSCA, Congress instructed EPA to review
Status new chemicals. New chemicals are those which do not
appear on the Agency's inventory of existing chemicals.
Under Section 5(a), manufacturers must notify the Agency
of their intent to manufacture or process a new chemical
through the PMN process. EPA has devoted significant
resources in FY'83 to refining the PMN review process;
to developing appropriate analytical tools for review of
new chemicals, to executing the reviews and, where
appropriate, making the decision to regulate new
chemicals.
Section 5(e) of TSCA authorizes EPA to propose an
order to regulate a new chemical, pending the
development of information that is needed to make a
reasoned evaluation of its health and environmental
effects. This authority is used if additional data are needed
to evaluate whether a chemical may present an
unreasonable risk or may result in significant or substantial
environmental release or human exposure.
Section 5(f) authorizes EPA to issue rules, or orders
controlling the manufacture, processing, or distribution of
individual new chemicals in commerce that present or will
present unreasonable risks. EPA identified two potential
Section 5(f) actions in FY'83. In both cases the submitting
company voluntarily withdrew the PMN.
Regulations written pursuant to Section 5 also require a
manufacturer to provide a Notice of Commencement of
Manufacture after EPA review of the PMN is completed.
This notice is given when the manufacturer is actually
ready to begin producing the substance. It is at this point
that a new chemical is added to the EPA inventory of
existing chemicals.
With its experience in new chemical review and
regulation, EPA can now act more quickly to identify
potential problems or gaps in data. This is partly due to
the refinement of the PMN program but also reflects a
general improvement in the quality and quantity of data
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being generated by submitters. With EPA's programmatic
refinements and improved quality of data available to EPA
decision-makers, the PMN program has evolved to a
sophisticated problem identification and control tool. (See
Table 1).
For example, since the beginning of the program in
1979 through September, 1983, EPA has received 3012
PMNs; issued 14 Section 5(e) orders banning or
controlling exposure to 27 chemicals, pending the
development of additional data — 10 of these orders,
covering 16 chemicals (one of these 16 represents 106
Synfuel PMNs), were issued this year. In one major action
under the PMN program, EPA reviewed a notice
submitted by Union Oil Company on a wide range of new
synthetic fuels to be derived from oil shale in the nation's
first commercial shale oil project. Union Oil Company
provided extensive information on its products in the
notice, including interim data on long-term toxicity tests.
After extended negotiations, EPA and Union entered into
a Section 5(e) consent agreement that required controls
on workplace exposure and environmental release, and
limiting the overall production of shale oil until the
long-term tests were completed and the results reviewed.
In addition to those Section 5(e) actions which EPA
issued, 20 PMNs were withdrawn by their submitters in
anticipation of EPA action under 5(e).
PMN Until recently the PMN process was conducted under an
Rule interim policy with proposed rules. The final PMN rule,
together with a mandatory notice form, was issued on
May 13, 1983 (48 FR 21722). In response to petitions
received in June, 1983 from the Chemical Manufacturers'
Association (CMA) and the Society of the Plastics Industry
(SPI), EPA postponed the effective date of the PMN rule
to allow clarification of specific rule provisions. On
September 13, 1983 a Federal Register Notice (48 FR
41132) was published which announced that the major
provisions of the PMN rule would go into effect on
October 26, 1983. These requirements will promote
standardized PMN reporting and recordkeeping
procedures. They will allow EPA to more effectively
address the increasing number of PMNs it is now
receiving and will ensure consistent enforcement of
Section 5 provisions. Three provisions regarding
exemptions for research and development activities, the
definition of "possession or control," and data
requirements on related chemicals have been stayed
pending further review. EPA's interim policy will continue
to govern these questions until final provisions have been
developed.
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Exemptions
The statutory determination for exempting chemicals from
the PMN process requires an Agency finding that such
chemicals will not present an unreasonable risk (Section
5(h)(4)). EPA has found that for many new chemicals its
review can be completed in the first three weeks of the
90 day period. EPA has, therefore, identified certain
chemicals and categories of chemicals that can be
exempted from full PMN review and has proposed rules
to exempt those chemicals. The intent of these proposed
rules is to allow companies to manufacture low risk
chemicals more promptly and to allow EPA to devote
more time and resources to detailed reviews and
follow-up actions for other chemicals .which raise serious
concerns. These broad exemption categories include site
limited intermediates (chemicals that react to form other
chemicals at their site of manufacture), chemicals that are
produced in small amounts (i.e., less than 10,000 kg./yr.),
and certain polymers. These rules were proposed in
August 1982 and resulted in many public comments.
These comments covered the entire spectrum of concern
from industry fears that the burdens associated with
complying with the exemption were too great to the
public's concern that the exemptions compromised'the
safeguards imposed by the PMN process. After evaluating
these comments, EPA developed final rules, which are
currently undergoing final review.
Under Section 5(h)(1) of TSCA, EPA can grant
exemptions to full PMN review for substances produced
for test market purposes if the substance does not
present an unreasonable risk to human health and the
environment under test marketing conditions. In FY'83
EPA acted on 81 test market exemption applications, of
which 74 were granted, 2 denied and 5 were withdrawn
in anticipation of EPA denial. EPA's review of test market
exemption requests places the burden for establishing no
unreasonable risk findings on the manufacturer. If there is
insufficient data to make this finding the application is
denied.
Follow-up
Program
An additional element of the PMN review program is a
strategy to track new chemicals that might be of concern
if their uses change or production volumes increase after
their initial PMN review. EPA employs two major
follow-up tools to ensure the re-evaluation of any PMN
chemical that has the potential to present an
unreasonable risk under new conditions of use.
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First, the Section 5(a) significant new use (SNUR)
provisions allow EPA to review a given chemical before
manufacture or processing for a new use that is
significantly different from that described in the original
PMN submission, and that would cause EPA concern,
such as changes in use that would change or increase
human or environmental exposure. Such uses would
include major increases in production volume, changes in
methods of manufacture or processing or use of a
chemical in different types of products.
Second, the Section 8(a) information gathering
requirements allow EPA to require manufacturers to
report information that is needed to fully evaluate the
uses, production volumes, descriptions of by-products,
health and environmental effects data, or exposure to the
chemical. Hence, this "as needed" reporting requirement
serves to identify any change in a chemical status not
previously identified.
FY'83 was the first year in which EPA fully
implemented the follow-up program. Since PMN reviews
began in 1979, approximately 275 chemicals have been
identified as possible follow-up review candidates. During
the past year this backlog of follow-up candidates was
subjected to a staged review process to determine if
there was sufficient toxicity and exposure concern to
warrant follow-up action by EPA. In addition EPA promptly
acted on those chemicals identified during the year for
follow-up action.
As a result of the emphasis placed on follow-up, the
Agency initiated regulatory action to follow-up after
commercialization on 1 ? of these chemicals. These
actions took the form of one significant new use rule and
ten Section 8 information collection rules. The Agency
also prepared documentation explaining why no action
was taken on those chemicals for which it found no
regulatory action was necessary.
In FY'83, EPA adopted a practice of issuing SNURs in
conjunction with Section 5(e) orders. A SNUR extends the
conditions of the Section 5(e) order to other
manufacturers and processors who otherwise could make
or process the chemical without the restrictions in the
original Section 5(e) order. It ensures that the original
submitter does not suffer a competitive disadvantage. In
1983, EPA proposed four significant new use rules in
conjunction with Section 5(e) orders; three covering five
new chemicals and one on an existing chemical.
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4
Existing Chemicals
Program ln pyga EPA instituted a new OTS project management
Status program for evaluation of risks associated with existing
chemicals. This program undertook more than 60
evaluations on chemicals for which: (1) Section 4 test
data were received, (2) Section 8(e) notices regarding
substantial risk were received, (3) test data have been
received from other sources, such as the National
Toxicology Program, (4) Section 21 petitions were
received, or (5) concerns have been raised consistently
during PMN review.
The purpose of each chemical evaluation is to consider
a chemical's risks in a five-phase process. The phases are
termed: entry review, problem characterization,
information gathering and risk analysis, risk reduction
analysis, and risk management. Only those chemicals for
which significant risks are identified will complete all of
the phases. Chemicals which are found not to pose
significant risks are dropped from further evaluation and
the resources are reprogrammed to evaluation of other
chemicals.
In FY'83 the existing chemicals program received and
reviewed a substantial amount of data on existing
chemicals. A summary of existing chemical program
activities can be found in Table 2. The Section 4
negotiated testing program resulted in submission of 200
completed test studies by industry. Section 8(a) and
Section 8(d) rules resulted in submission by the chemical
industry of 3,159 studies and reports on existing
chemicals. Under the Section 8(e) substantial risk
notification program, EPA received 35 initial reports, 59
"For Your Information" submissions, and 94 supplements
related to previous initial reports, totalling 188 for FY'83.
Twenty-six NTP studies were also received and reviewed
by OTS. Chemical Hazard Identification Profile documents
were prepared for 20 of the chemicals. Those profiles
collect and evaluate the available information on the
chemical and identify data gaps. They are used in the first
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phase (entry review) of the existing chemicals project
management program to evaluate risk.
The various actions which result from these evaluations
include initiation of rulemaking under Section 6 for risk
control, under Section 5 for reporting of significant new
uses, under Section 8 for information reporting or
recordkeeping, under Section 4 for testing and issuance of
chemical advisories to inform those concerned of
measures that can be taken to mitigate potential risks.
As a result of the 64 chemical evaluations undertaken in
FY'83, approximately 30 chemicals were targeted for
further analyses and decisions in FY'84, eight chemicals
were moved into development of Section 5 or Section 8
rules, one chemical, methylenedianiline (4,4'-MDA) was
identified as a Section 4(f) candidate, and five chemicals
were moved into risk management (Section 6 regulatory
development). About 20 chemicals were dropped and the
resources were reprogrammed for 20 other chemicals
which replaced them in the program.
Priority review under Section 4(f) of TSCA identified a
number of control actions which could alleviate potential
problems associated with 4,4'-MDA. As a result EPA
issued an Advance Notice of Proposed Rulemaking
(ANPR) in September 1983 on 4-4'-MDA. An ANPR was
issued on methylenebis (2 chlorobenzenamine), MBOCA,
in May 1983.
Three separate rules were proposed or promulgated on
PCBs in FY'83. A rule, setting numerical cutoffs for
purposes of defining the absence of PCBs in releases
from closed/controlled systems, was published in October
1982. This rule also adds additional disposal mechanisms
to the list of acceptable practices. Two amendments, one
for railroad transformers and one procedural rule regarding
approval authority for PCB disposal, were also published
in FY'83.
Ten Section 8 rules and one SNUR on an existing
chemical were issued in FY'83. As each new ITC list is
submitted to EPA, the Agency will automatically amend
the Section 8(d) rule and propose new Section 8(a) rules
to include the chemicals on each list. This will ensure that
all available information is submitted to the Agency for
use in decisionmaking for Section 4 test rules. The
Section 8(d) health and safety rule was amended three
times in FY'83 to include ITC chemicals from the 6th-12th
lists. A proposed Section 8(a) rule specifically requiring
information on chlorinated terphenyls was published on
April 29, 1983. Four Section 8(a) Preliminary Assessment
Rules were published to trigger automatic reporting on all
ITC designated substances and to cover the 6th-9th and
11th and 12th lists of chemicals proposed by the ITC. The
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Section 8(c) rule discussed earlier was finalized on August
22, 1983. The first existing chemical SNUR was proposed
on a category of chemicals known as chlorinated
naphthalenes on May 6, 1983.
To support its existing chemicals program and to
complement the Section 4 testing program, EPA conducts
chemical-specific and broad-based monitoring activities.
Chemical-specific monitoring is conducted to obtain data
on chemical exposure necessary to support regulatory
decisionmaking. Generally available information on
exposure to existing chemicals is often unreliable or
difficult to interpret. Chemical-specific monitoring activities
are designed to resolve these problems by measuring
actual levels of human and environmental exposure to the
specific substance.
In addition to chemical-specific monitoring, EPA also
conducts broad-based monitoring studies to identify
potential regulatory candidates and to define a baseline of
exposure to specific chemicals of concern. An example of
such monitoring is the National Human Adipose Tissue
Survey, the results of which were released by EPA in May
1983. These studies indicated that the estimated
percentage of the national population having greater than
three parts per million (ppm) levels of PCBs in adipose
tissue has decreased from eight percent to one percent
from 1977 to 1981. This level had increased from 2.7
percent to eight percent of the population from 1972 to
1977. These results indicate that exposure levels for PCBs
have been decreasing.
Information from these broad studies helps EPA plan
future TSCA ambient monitoring programs, identify
candidates for testing under Section 4 or for regulatory
controls under other TSCA authorities, and evaluate the
effectiveness of TSCA actions in protecting human health
and the environment.
Existing
Chemicals
Control
The general progress of the Existing Chemicals Control
Program has been presented in earlier sections. FY'83
actions on specific chemicals are presented below:
Methylene Bis (2-Chloroaniline) - (MBOCA)
On May 23, 1983, EPA published in the Federal Register
(48 FR 22954) an Advance Notice of Proposed
Rulemaking (ANPR) on MBOCA. MBOCA is used as a
curing agent in the manufacture of certain polyurethane
plastics and has been demonstrated to be carcinogenic in
animals. EPA is concerned that the risk from exposure to
MBOCA may be unreasonable and is exploring a range of
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regulatory options including a complete or partial ban. The
primary risks from MBOCA appear to be to plastics
formulators, generally working in small establishments.
Currently there is no OSHA standard for this chemical.
4,4'-Methylenedianiline - (4,4'-MDA)
4,4'-MDA is a high production chemical used primarily as
an intermediate to make other chemicals and plastics. In
June, 1979, 4,4'-MDA was designated for testing
consideration by the Interagency Testing Committee (ITC).
In June 1982, the National Toxicology Program (NTP)
completed a study which indicated serious carcinogenic
potential. Completion of the NTP study was a major factor
in EPA's June 1983 decision not to require additional
tesing under section 4 of TSCA. However, prompted by
this study, evidence of potential high level workplace
exposure, and the absence of a Federal workplace
standard, EPA initiated priority review of 4,4'-MDA under
Section 4(f) in April 1983. As a result of this review, EPA
determined that regulatory action was necessary, and
jointly with OSHA, issued an ANPR on September 20,
1983.
Asbestos
Asbestos is a demonstrated human carcinogen. It causes
mesothelioma, lung cancer and other cancers, as well as
asbestosis. Asbestos has been the subject of EPA TSCA
activities since the early years of the program as well as
the subject of activity by other Federal agencies. To more
effectively coordinate these Federal activities in FY'83,
EPA joined several other government agencies in
establishing the Federal Asbestos Task Force. Current
members of the Task Force are EPA, the Consumer
Product Safety Commission, the Occupational Safety and
Health Administration, the Food and Drug Administration,
the National Institutes of Environmental Health Sciences
and the National Cancer Institute. The Mine Safety and
Health Administration and the National Institute for
Occupational Safety and Health have also been invited to
join. During FY'83 EPA also articulated a clear program
under TSCA to control exposures to commercial and
industrial uses of asbestos.
Polychlorinated Biphenyls (PCBs)
Section 6(e) of TSCA specifically bans the manufacture,
processing, distribution in commerce and use of PCBs
with certain exceptions. Section 6(e) also requires EPA to
issue regulations regarding disposal and labeling of
materials containing PCBs.
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During FY'83 four final rules regarding PCBs were
promulgated in the Federal Register. The first rule, issued
on October 21, 1982, (47 FR 46980), set numerical cutoffs
(parts per million) for purposes of defining the absence of
PCBs in releases from closed and controlled waste
processes. The rule also adds additional disposal practices
to the list of acceptable mechanisms for the disposal of
controlled wastes containing PCBs in concentrations
between the limit of quantitation and 50 parts per million.
Finally, the October rule instituted new recordkeeping and
reporting requirements.
The second rule, issued on January 3, 1983 (48 FR 124)
amended an earlier rule regarding use authorization for
PCB railroad transformers. This rule requires railroad
transformers to meet a level no greater than 60,000 ppm
concentration of PCBs by July 1, 1984.
The third rule, published on February 8, 1983 deals with
the updating of analytical test methodology.
The fourth issued on March 30, 1983, (48 FR 13181) is a
procedural rule regarding approval authority for PCB
disposal facilities and guidance for obtaining approval.
Chlorinated Naphthalenes and Chlorinated Terphenyls
Chlorinated naphthalenes (CNs) and chlorinated terphenyls
(CTs) are organic chemicals with a wide range of uses.
They were designated for Section 4 testing consideration
by the Interagency Testing Committee (ITC) because of
possible carcinogenicity and other health concerns.
However, the use of chlorinated naphthalenes has
declined to low levels, while chlorinated terphenyls are no
longer used in the United States. As a result, EPA
concluded that test rules were not justified at this time.
To ensure against renewed production or expansion of
current uses without adequate review, the Agency will
monitor these chemicals through Section 5 and Section 8
rules.
On April 29, 1983 EPA published a proposed rule in
the Federal Register (48 FR 19419) under Section 8(a)
which requires manufacturers or importers of chlorinated
terphenyls to report to EPA certain information on existing
and proposed production.
On May 6, 1983, EPA published a proposed rule under
Section 5(a)(2) defining a significant new use of
chlorinated naphthalenes. Under this rule, any domestic
manufacture of chlorinated naphthalenes or any
cumulative import over 100,000 pounds a year is
considered a "significant new use" and subject to review
by EPA under Section 5 PMN requirements.
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Information Section 8 of TSCA includes several authorities for
Activities requiring reporting of production and use information.
Section 8 reporting requirements enhance the Agency's
ability to make decisions concerning the need for
chemical testing or control activities. These requirements
also are used to obtain information to support test rule
development and risk assessments for the existing
chemicals program.
Section 8(b) requires the Administrator to compile an
inventory of chemicals existing in U.S. commerce during
the period of January 1, 1975 through December 31, 1977
and to update the listing of chemicals by adding newly
manufactured substances that have been reviewed under
the PMN program.
The purpose of Section 8(e) is to ensure that
information which reasonably supports the conclusions
that a chemical substance or mixture presents a
"substantial risk" to health or the environment is brought
to EPA's attention immediately upon discovery and not
solely just upon request by the Agency. "Substantial risk"
information received by the Agency may indicate the need
for further evaluation which may in turn lead to control.
Therefore, each Section 8(e) submission is reviewed by
the Agency immediately upon receipt. The information is
analyzed in conjunction with other data available to EPA
on the reported chemical and its analogs. A status report
is prepared for each submission. The status report
summarizes the nature of the problem, available data on
the chemical, and recommends disposition. The
recommendations can range from no further action
required to referral to another agency to immediate
control. In any case, the reported data are available for
use by other programs and agencies that are currently
studying the reported chemical. Section 8(e) is a valuable
tool in early identification of potential substantial risk
situations and helps to focus Agency resources on
chemicals of the highest concern.
In FY'83 EPA received 35 initial Section 8(e)
submissions, 94 follow-ups on initial Section 8(e)
submissions and 59 "For Your Information" submissions
(not statutorily required). Twenty-nine of the initial
submissions were referred for further evaluation within
the Existing Chemicals Program while for 28 of the initial
submissions the submitter reported instituting voluntary
risk reduction measures.
Last fiscal year EPA published a final TSCA Section 8(a)
Preliminary Assessment Reporting Rule which requires
manufacturers of certain chemicals to report general
production, use, and exposure information. These data are
crucially important to the Agency's review of chemicals
18
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31.
designated by the Interagency Testing Committee (ITC). In
FY'83 EPA issued four Section 8(a) rules amending the
Preliminary Assessment Reporting Rule. As mentioned
earlier, two final amendments added chemicals from the
6th through 9th ITC lists and from the 11th and 12th ITC
lists to the rule. The Agency also proposed the addition of
chemicals listed by the ITC in its 11th report. These
actions establish reporting requirements for 51 existing
chemicals. Another Section 8(a) amendment established a
requirement for automatic reporting by manufacturers of
chemicals designated by the ITC.
In FY'82 the Agency promulgated a Section 8(d) rule
which requires manufacturers of certain chemicals to
provide health and safety studies conducted on those
substances. By adding each new ITC list to both the
Section 8(a) and 8(d) rules, EPA ensures that it will
receive current information on those substances under
review.
In FY'83 EPA implemented another major TSCA
information authority. On August 22, 1983 the Section 8(c)
Allegations of Significant Adverse Reactions Rule was
promulgated. This rule requires manufacturers and
processors to keep records of such reactions to health or
the environment that allegedly were caused by a
chemical. Records concerning health effects on
employees must be kept for 30 years; other records i.e.,
environmental release, for five years. Unlike the other
major Section 8 rules, these records are not submitted to
EPA but are maintained by industry. Under the rule EPA
can require that all records on a specific substance be
submitted to the Agency or may require access to the
records at the site where they are kept. EPA will use this
rule to strengthen and support the existing chemicals
program. The Section 8(c) rule will also assist industry to
identify substantial risk cases and may trigger reporting to
the Agency pursuant to TSCA Section 8(e).
In developing TSCA, Congress clearly recognized the
need for broad public access to data on commercial
chemicals and chemical hazards. It charged EPA with
specific responsibility for sharing data obtained under the
Act with all interested parties — including Federal, State
and local agencies responsible for the protection of health
and the environment. EPA's information-sharing
responsibilities are especially important because of its
unique authority under TSCA to gather or require the
development of data on industrial chemicals. This sharing
of information is limited only by the confidential business
information protection guaranteed by TSCA.
During FY'83 several interagency information-sharing
activities were conducted. EPA, in conjuction with the
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Consumer Product Safety Commission, published a
technical guidance document entitled Asbsestos in
Homes Booklet which provides guidance for detecting and
remedying problems with asbestos in the home. In FY'83
EPA published another document entitled Guidance
for Controlling Friable Asbestos-Containing Materials in
Buildings.
The purpose of the report is to supplement previous
EPA guidance by emphasizing recent experience and new
information on asbestos abatement and control. This
document will be most helpful to school officials and
building owners who are considering implementing an
asbestos»control program. EPA has also worked out a
system for sharing Section 8(a) data and Section 5 data
with both CPSC and OSHA.
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5
Chemical Testing
CA ? EPA's chemical testing program is one of the focal points
btatUS for tne development and accumulation of test data under
TSCA. Test data developed under the authority of TSCA
Section 4 narrows the gap of scientific knowledge for
other regulatory agencies as well as for EPA. Section 4 of
TSCA gives EPA the authority to require manufacturers
and processors of a designated chemical to test for
certain health or environmental effects. As mentioned
previously Section 4 also established an Interagency
Testing Committee which designates chemicals for
priority testing consideration. The ITC's list of designations
is limited to 50 chemical substances at any one time,
although additional chemicals may be added as EPA
responds to previous designations. The Committee, under
the Act, must consider revising its list every six months.
EPA must respond within one year to each designation by
initiating rulemaking to require testing or by providing
reasons for not doing so.
In 1979 the EPA was sued by the Natural Resources
Defense Council for failure to respond to ITC designations
within the statutory deadline of one year. The result of the
suit was a court order establishing a three-year schedule
to respond to the backlog of chemicals from ITC lists 1
through 6 and to remain current on all newly designated
chemicals. By the end of FY'83 the Agency had complied
with the statutory deadline for all new ITC designations.
(The Agency, by December 31, 1983 eliminated the
backlog, as required by the court order).
In responding to ITC designations, EPA places
considerable importance on developing needed test data
rapidly, so potential risks can be identified as soon as
possible. As a result, where appropriate, EPA develops
negotiated testing programs with manufacturers or
industrial consortia, rather than promulgating test rules to
obtain these data. This is often in industry's interest as *
well as EPA's because, according to industry, ITC
designations can place chemical companies at a
21
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competitive disadvantage. Therefore, industry has an
incentive to complete testing and to clear up any
uncertainties as soon as possible. EPA believes that
negotiated testing programs are in the public interest and
are sometimes preferable to rulemaking because they will
provide the needed test data substantially sooner than
could be accomplished through rulemaking. If EPA has
reason to believe that industry has not acted in good faith,
the Agency can still initiate formal Section 4 test rules.
In FY'83, EPA responded to a total of 23 ITC
designations. Sixteen were backlogged designations and
seven were new ITC designations. These produced seven
decisions not to test; ten Negotiated Testing
Agreements; and six proposed rules. Table 3 reflects
FY'83 actions taken on ITC designated chemicals.
Test
Guidelines
Section 4 of TSCA also requires the development and
annual review of test standards and guidelines. EPA has
developed test guidelines for a wide variety of health and
environmental effects. These guidelines are available
through the National Technical Information Service (NTIS).
To ensure that the guidelines are consistent and of
accepable scientific quality, EPA implemented a process
that ensures that all guidelines are peer reviewed by
scientists in other EPA Program Offices and by expert
scientists from academia, State and other Federal
agencies, public interest groups and industry. In FY'83
EPA published six new guidelines for conducting basic
health and environmental effects and environmental fate
testing. These guidelines have been harmonized with the
testing guidelines published by the OECD.
Section 4 requires EPA to perform an annual review and
update of published guidelines to ensure their adequacy.
Using responses from solicited public comments and
other information gathering procedures, EPA reviews the
guidelines to ensure that they reflect the most current
and valid testing practices. During FY'83, EPA revised 40
of the 80 guidelines published in FY'82 after determining
that technical areas of the guidelines needed updating. All
but one of the revisions were minor.
Reimburse-
ment of
Testing Costs
22
To ensure fair distribution among chemical manufacturers
of costs connected with performing required testing under
Section 4, EPA published a final data reimbursement rule
under Section 4(c)(3)(A) on July 11, 1983 (48 FR 31786).
-------
The rule sets forth methods for voluntary allocation of
costs among those subject to a test rule and provides a
framework for the efficient resolution of disputes that the
parties choose to refer to EPA, if they cannot come to a
settlement. The rule incorporates the procedures of the
American Arbitration Association. The arbitration officer
hearing these disputes and rendering the initial cost
allocation decision would be appointed from the private
sector rather than from the Federal government.
Quality In order to maintain the scientific integrity of EPA's
of Data decisionmaking regarding the regulation of chemical
substances, the Agency pursues a rigorous program to
ensure the quality of data received as a result of TSCA's
testing requirements. In addition to test guidelines
discussed previously, EPA scrutinizes in other ways the
quality of data upon which it must make crucial decisions.
At the close of FY'83 EPA had drafted a rule specifying
"good laboratory practices" that must be observed by
laboratories conducting tests in compliance with TSCA.
At the close of FY'83 this rule was in final review and has
now been signed by the Administrator. This rule specifies
requirements for recordkeeping and data handling
procedures, animal care, personnel qualifications, and
similar practices.
Also, in FY'83, EPA developed health and environmental
data audit procedures to monitor compliance with
procedures specified in negotiated testing agreements
and Section 5(e) orders. These procedures ensure that
audits are conducted in a consistent fashion. In
cooperation, EPA's Office of Enforcement and Compliance
Monitoring and the Food and Drug Administration,
perform periodic inspections and audit testing programs
conducted under TSCA. Compliance monitoring personnel
inspect the laboratory facility and TSCA program
personnel audit the actual test study. In FY'83 13
laboratories and 93 test studies were subjected to audits.
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6
Enforcement
Under Section 16 of TSCA, EPA may levy either civil or
criminal penalties for a violation of several sections of the
Act. The Agency has developed specific enforcement
strategies for implementing regulations under TSCA.
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 the application of inspection
resources, and establish a policy for determining civil
penalties under the regulation.
Civil Enforcement Actions
In FY'83, most of the enforcement actions under Section
16 involved alleged violations of the PCB rules. The
Agency filed a total of 285 civil complaints during the
fiscal year as a result of PCB inspections; 203 cases were
completed; and $1,364,652 in civil penalties were
assessed. Figures for each EPA Region appear in Table 4.
In addition to the PCB cases, the Agency issued six civil
complaints to companies for alleged violations of the
Section 5 Premanufacture Notification (PMN)
requirements and three civil complaints for alleged
violations of the Section 6 dioxin disposal requirements.
These complaints represent the first PMN and dioxin
enforcement actions taken by the Agency under TSCA.
Civil penalty assessments for infractions of the PMN
requirements totaled $334,000.
Criminal Enforcement Actions
Criminal cases must be filed on EPA's behalf in Federal
court by the Department of Justice. In FY'83, five cases
alleging criminal violations were referred to the
Department of Justice for consideration. One of these
cases, U.S. vs. Baseman, et a/., has resulted in a
conviction. Defendent Baseman entered a plea of guilty to
two counts under TSCA; one count for illegal interstate
transportation of PCB and PCB containers and one count
24
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for improper disposal of PCB material. Grand jury
indictments were returned in two other TSCA cases
which had been referred to the Justice Department prior
to FY'83.
Compliance Actions
The EPA took action to enforce compliance with various
TSCA requirements. The EPA, along with-five State
agencies cooperating under the terms of enforcement
grants-in-aid, conducted 1,633 PCB compliance monitoring
inspections. The Agency conducted 19 inspections to
monitor compliance with the interagency ban on
nonessential aerosol uses of chlorofluorocarbons and
conducted 55 inspections to determine compliance with
the dioxin rule under Section 6. The Agency also
conducted 126 compliance monitoring inspections at
facilities subject to Section 5 requirements.
During FY'83, the Agency initiated inspection programs
to monitor compliance with Negotiated Testing
Agreements which were developed in lieu of Section 4
test rules, the Section 6 asbestos-in-schools rule, and the
TSCA Section 8(a) level A reporting requirements. The
Agency inspected 13 laboratories conducting testing
under Negotiated Testing Agreements to determine if the
laboratories were in compliance with agreed-upon good
laboratory practice requirements. During these
inspections, 93 data audits of health and environmental
tests were conducted to determine if testing was being
conducted in accordance with test protocols, and if
reports accurately reflected study findings. Compliance
inspections were conducted at 207 local education
agencies to determine compliance with the Section 6
asbestos-in-schools rule. The Agency also conducted 83
compliance inspections to determine compliance with
Section 8(a) level A reporting requirements.
Program Actions
During FY 1983, EPA developed and issued compliance
monitoring strategies for the TSCA Section 5(h)(4)
Premanufacture Notice Exemption for Chemicals Used in
or for Instant Photographic or Peel-Apart Film Articles, the
Section 6 dioxin rule, the asbestos-in-schools rule, and the
Section 8(a) asbestos reporting rule. EPA also issued
enforcement response policies for the dioxin rule and the
asbestos-in-schools rule, and developed compliance
assistance guidelines for the asbestos-in-schools rule.
Pilot cooperative enforcement agreements with five
States, (California, Connecticut, Maryland, Michigan, and
Ohio) continued in FY 1983. These agreements
supplement EPA compliance monitoring activities and
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provide data for use by EPA in developing policy and
guidance to support a continuing and expanded
cooperative enforcement program with the States.
26
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7
Litigation
Environmental Defense Fund, Inc. v. Environmental
Protection Agency (Mo. 79-1580, D.C. Cir.)
In 1979 the Environmental Defense Fund (EOF) petitioned
for review of EPA's regulations under TSCA Section
6(e)(2) and (3) governing the manufacture, processing,
distribution, and use of polychorinated biphenyls (PCBs). A
decision largely in EDF's favor was issued on October 30,
1980. This decision and its aftermath were described in
reports for previous years. Developments of this case for
Fiscal Year 1983 are described below.
On August 18, 1982, EPA, in response to previous
Court orders in this case, promulgated a final rule on the
use of PCBs in electrical equipment. Petitions for review
of that rule were filed by several parties in the U.S. Court
of Appeals for the District of Columbia Circuit and the
U.S. Court of Appeals for the Fourth Circuit. EDF also
amended its petition for review in the original PCB case.
By the end of calendar year 1982 all dockets were
consolidated for hearing. The various parties to this
consolidated proceeding, in order to reconcile their views
on the validity of the EPA rule, began settlement
negotiations in early 1983. EPA, EDF and NRDC have
since indicated that they may be able to arrive at a
separate agreement as to the issues in controversy
among them. These parties were close to agreement at
the end of Fiscal Year 1983. A schedule with respect to
other issues in the case involving other parties is
expected to be developed early in Fiscal Year 1984.
On October 12, 1982, EPA issued a rule excluding from
the restrictions of Section 6(e) of TSCA certain PCBs
generated in closed processes or discharged into wastes
which are disposed of in an acceptable manner. A petition
for review of this rule was filed by the Chemical
Manufacturers Association on December 23, 1982. By
agreement of the parties, approved by the Court, this
petition has been stayed pending further PCB rulemaking
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On November 1, 1982, EPA requested that the D. C.
Circuit Court further extend its stay of mandate until
October 1, 1984, to allow further rulemaking for all PCBs
not covered in the August and October 1982 rules. On
December 17, 1982, the court extended the mandate for
an indefinite period, but required the agency to report to it
on a quarterly basis its progress in achieving rulemaking.
Warren County v. North Carolina (No., 79-560-CIV-5)
and Twitty v. North Carolina (No. 80-41 -CIV-5) (E.D.N.C.)
These actions were brought by Warren County and private
parties against the State of North Carolina and EPA to
prevent a tract of land in Warren County from being used
as a landfill for the disposal of soil contaminated with
PCBs. The cases were decided by the Federal District
Court in EPA's favor. Significant events in these actions
were described in last year's report. Warren County and
the plaintiffs in Twitty filed notices of appeal with the U.S.
Court of Appeals for the Fourth Circuit. Warren County
voluntarily dismissed its appeal. On December 27, 1982
the Fourth Circuit reaffirmed the decision of the District
Court in the Twitty appeal.
T. Mitchell Langdon et al. v. James B. Hunt et. al. (No.
86-487-CIV-5, E.D.N.C.)
This is another case arising out of the Warren County,
North Carolina, PCB situation. It has been described in
reports from previous years. On May 17, 1983, the
District Court, in accordance with an agreement by the
parties, dismissed all claims in this case.
The Dow Chemical Company v. Ruckelshaus (No.
82-3536, 3d. Cir.) and The Dow Chemical Company v.
Ruckelshaus (No., 80-1498, 3d. Cir.) [The latter case is an
appeal from The Dow Chemical Company v. Costle (Civ.
Action No. 79-581, D. Del.), described in previous years'
reports.]
Case No. 82-3536 involves a petition for review of an EPA
order assessed against Dow for violation of EPA's PCB
regulations. Case No. 80-1498 is an appeal from a
judgment in Federal District Court which dismissed Dow's
attempt to obtain pre-enforcement judicial review of the
regulations appealed in No. 82-3536. The District Court
had held that TSCA lodges jurisdiction over
preenforcement judicial review of TSCA regulations
exclusively in the Court of Appeals within 60 days of
promulgation of those regulations. The cases involved
related issues and were consolidated in the Third Circuit
on appeal.
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Dow was prosecuted under EPA regulations that
require products containing more than 500 parts per
million (ppm) PCBs to be labeled. Dow failed to label a
product that contained more than 500 ppm
monochlorinated biphenyl (MCB). EPA has interpreted
TSCA to require it to regulate MCBs as PCBs. That
interpretation was questioned in comments on EPA's
proposed rule, and Dow challenged that interpretation in
enforcement proceedings.
At the same time EPA was engaged in rulemaking to
replace regulations that were invalidated by the D.C.
Circuit Court in EDF v. EPA (described above). EPA was in
the process of revising its regulations as they relate to
products containing trace amounts of PCBs. On April 15,
1983, certain plaintiffs in EOF v. EPA (EDF, Natural
Resources Defense Council, and the Chemical
Manufacturers Association (CMA)) jointly submitted a
"consensus proposal" for the rulemaking. EDF, NRDC and
CMA recommended, among other things, that companies
which manufacture up to 1250 ppm of MCBs in their
products be exempt from regulation under TSCA. EPA had
determined that it intended to include the suggested
provisions in proposed regulations and would issue final
regulations containing such a provision by July 1984,
subject to comments received. Thus, completely
independent of the Dow litigation, EPA, at the urging of
industry and environmental groups, decided to amend its
PCB regulations to make Dow's product subsequently
legal.
Accordingly, EPA and Dow entered into settlement
discussions in Dow v. Ruckelshaus. On August, 2, 1983,
EPA and Dow settled the case by agreeing that, if EPA
promulgates a final rule that would affect MCBs as
described above, Dow would drop its challenge to EPA's
interpretation of TSCA and would pay the entire penalty
assessed in the enforcement action ($120,000).
Metro-North Commuter Railroad Company v. EPA (No.
83-3213, 3d Cir.) and Southeastern Pennsylvania
Transportation Authority v. EPA (No. 83-3116, 3d Cir.)
Two railroad organizations challenged EPA's regulations to
require reduction in PCB concentrations in railroad
transformers. Under the regulation, the railroads would
have had to reduce one-third of their transformers to
60,000 ppm PCB concentration by July 1, 1983, and
eventually, would have had to meet a series of deadlines
to reduce all their transformers to 1,000 ppm PCB
concentration. The railroads challenged the early
compliance deadlines. EPA entered into settlement
negotiations with the railroads and, in July 1983, the
29
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parties agreed to extend the earliest compliance
deadlines, but agreed that, ultimately, the railroads would
comply with the 1,000 ppm requirement in all their
transformers by the original final deadline of July 1, 1986.
Cramer v. EPA (No. 83-1314, D. Kan.)
On April 1, 1983, plaintiff filed a citizen's suit under
Section 20 of TSCA to require EPA to investigate and
prosecute a PCB storage facility near his home in Mound
Valley, Kansas. Section 20 authorizes citizen suits to
compel EPA to perform nondiscretionary acts.
EPA argued that Section 20 does not apply to Agency
decisions whether to prosecute, since those decisions are
discretionary. Besides, plaintiff has a remedy at law by
way of a citizen's suit directly against the storage facility.
Furthermore, EPA had already investigated the plaintiff's
allegations and had pursued a civil penalty action for
which monetary damages were assessed. The case was
dismissed by agreement of the parties, with no
obligations imposed on EPA.
Noble Automative Chemical and Oil Co. v. EPA (No.
81-1581) (D.N.J.)
Noble Oil filed suit to enjoin administrative penalty
proceedings against it for violations of PCB disposal and
marking regulations under TSCA. Noble argued that EPA
was acting to enforce regulations which had been
invalidated by the U. S. Court of Appeals for the District of
Columbia Circuit in EOF v. EPA, supra. EPA argued that
the D.C. Circuit's opinion did not affect the disposal and
marking regulations and filed a motion to dismiss Noble
Oil's case. The District Court dismissed Noble's Suit due
to lack of subject matter jurisdiction.
Natural Resources Defense Council v. EPA (No. 82-2039,
D.D.C)
On July 18, 1983, public interest groups challenged EPA's
decision not to take steps to place formaldehyde on a
priority track for evaluation under Section 4(f) of TSCA.
Under Section 4(f), if EPA receives information which
indicates that there may be a reasonable basis to
conclude that a chemical presents a significant risk of
serious or widespread harm to human beings from
cancer, gene mutations, or birth defects, EPA shall within
180 days initiate appropriate action under Section 5, 6, or
7 of TSCA to prevent or reduce the risk, or publish in the
Federal Register a finding that the risk is not
unreasonable. ,
Plaintiffs claim that EPA's decision, in late 1982, not to
evaluate formaldehyde under Section 4(f) was unlawful
30
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because EPA applied too strict a standard for triggering
the Section 4(f), "significant risk of serious or widespread
harm" finding, and because the decision was tainted by
unlawful Agency conduct. Plaintiffs claim that EPA had
improperly held private meetings with industry groups in
the summer of 1982 and had improperly evaluated animal
test data. The Agency is now examining the Section 4(f)
decision on formaldehyde.
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.)
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8
State Programs
State Section 28(c) of TSCA authorizes EPA to award grants to
Programs States to assist in programs that prevent or eliminate
problems created by toxic substances. Since 1978, EPA
has assisted eight States with the development of 11
toxic substances programs.
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 in each cycle. In April, 1979, cooperative
agreements were signed with Maryland, Michigan, New
Jersey, New York, and Wisconsin under the first cycle. In
February 1980, cooperative agreements were signed with
three States (New Jersey, North Carolina, and Puerto
Rico*). On February 11, 1980, EPA annouced in the
Federal Register the availability of an additional $1.25
million for a third and final cycle in the program.
Cooperative agreements were signed with Illinois,
Maryland and Michigan. Refer to Table 5 for the status of
these awards.
Four State cooperative agreement projects have been
completed. These projects are the Michigan Critical
Materials Program, the Wisconsin study of health
problems related to formaldehyde in mobile home
construction, the Maryland Toxic Substances Registry, and
the North Carolina toxics management project.
* As defined by TSCA, "State" includes any U.S. territory or possession.
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Table 1
Summary of New Chemical Actions
October 1, 1982 - September 30, 1983
Actions
Valid PMNs Received
Voluntary Testing in Response to EPA
Concerns
Voluntary Control Actions by
Submitters
PMNs Voluntarily Withdrawn in Light
of EPA Concern
PMNs Subject to Section 5(e) Orders
PMNs Subject to Section 5(f) Orders
Notice of Commencement of
Manufacture
No. of PMN
Actions
1301*
43
1
20
121*
0
316**
Aggregate
Total
Since
Beginning
(mid-1979)
3012*
53
31
24
132*
0
1232
* This number includes 106 synfuels
** This number includes PMNs received in previous fiscal years for which notices
were received in FY'83.
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Table 2 Summary of Existing Chemical Actions
RISK IDENTIFICATION - Action/Chemical # in FY'83
Testing Studies Received Under Section 4 200
Section 8(e) Submissions Received 188
Initial Submissions 35
"For Your Information" (FYI) Submissions 59
Supplemental/Follow up Submissions 94
National Toxicology Program Studies Reviewed 26
(see Table 2A for listing)
Chemical Hazard Information Profiles (see Table 2A 20
for listing)
Section 21 Petitions 3
GE petition for an amendment to the PCB Rule;
denied, 10/20/82 (47 FR 46723).
MET Electrical Testing Co. petition for an
amendment to the PCB Rule; denied, 4/20/83 (48 FR
16884).
Central Michigan petition for an investigation of
dioxin and furan pollution; denied, 7/25/83 (48 FR
33739).
RISK EVALUATION - Action/Chemical
Chemical Evaluations 64
Drop from further evaluation 20
Further analysis required 30
Develop Section 5 or section 8 rules 8
Develop Section 6 rules 5
Section 4(f) Designations 1
Risk Assessments 4
4,4'-Methylenedianiline (MDA)
Methylenebis (2-chloroaniline) (MBOCA)
Glycol ethers (2-methoxyethonal, 2-ethoxythonal
and their acetates)
Chloromethane
34
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RISK EVALUATION - Action/Chemical (Cont'd) # in FY'83
Section 8 Rules 10
Chlorinated Terphenyl; Submission of Notice of 1
Manufacture or Importation Proposed Rule, 4/29/83
(48 FR 19419).
- Records and Reports of Allegations that Chemical 1
Substances Cause Significant Reactions to Health or
the Environment; Recordkeeping and Reporting
Procedures Final Rule, 8/22/83 (48 FR 38178).
Recordkeeping and Reporting Requirements; 1
Recodification Final Rule; Redesignation, 5/25/83
(48 FR 23420).
Amendments to Section 8(a) Preliminary 4
Assessment Information Rule:
To include chemicals designated in the 6th-9th
ITC Lists Final Rule, 5/19/83 (48 FR 22694).
To include chemicals designated in the 11th
List Proposed Rule, 5/19/83 (48 FR 22697).
To include chemicals designated in the 12th List
Final Rule, 6/22/83 (48 FR 28843).
To require automatic reporting on all chemicals
and mixtures designated by the ITC for testing
consideration - Final Rule, 5/11/83 (48 FR 21294).
Amendments to Section 8(d) Health and Safety 3
Data Reporting Rule:
To include chemicals designated in the 6th-10th
ITC Lists Final Rule, 3/30/83 (48 FR 13178).
To include chemicals designated in the 11th ITC
List Final Rule, 12/03/82 (47 FR 54624).
To include chemicals designated in the 12th ITC
List- Final Rule, 6/01/83 (48 FR 24366).
35
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RISK MANAGEMENT - Action/Chemical # in FY'83
Control Rules 6
Advance Notices of Proposed Rulemaking/ 2
Proposed Rules:
Methylene Bis (2-Chloroaniline); Initiation of
Regulatory Investigation, Advance Notice of
Proposed Rulemaking 5/23/83 (48 FR 22954)
4,4'-Methylenedianiline; Initiation of Regulatory
Action, Advance Notice of Proposed
Rulemaking, 9/20/83 (48 FR 42898)
Final Rules: 4
Polychlqrinated Biphenyls (PCBs) Manufacturing,
Processing, Distribution in Commerce, and Use
Prohibitions; Use in Closed and Controlled Waste
Manufacturing Processes Final Rule, 10/21/83 (47
FR 46980).
Polychlorinated Biphenyls (PCBs) Manufacturing,
Processing, Distribution in Commerce, and Use
Prohibitions; Amendment to Use Authorization for
PCB Railroad Transformers Final Rule, 1/03/83 (48
FR 124).
Polychlorinated Biphenyls (PCBs) Manufacturing,
Processing, Distribution in Commerce, and Use
Prohibitions; Incorporation by Reference Revisions
(Updating Analytical Test Methodology) Final Rule,
2/08/83 (48 FR 5729).
Polychlorinated Biphenyls (PCBs); Procedural
Amendment of the Approval Authority for PCB
Disposal Facilities and Guidance for Obtaining
Approval; Procedural Rule Amendment and
Statement of Policy, 3/30/83 (48 FR 13181).
Significant New Use Rules 1
Category of Chemical Substances Known as
Chlorinated Naphthalenes Proposed Determination of
Significant New Uses - Proposed Rule, 5/06/83 (48
FR 20668).
CFC Exemption Requests 1
Fully Halogenated Chlorofluoroalkanes; Denial of
Exemption for Use of Chlorofluorocarbons in Aerosol
Self-Defense Chemical Weapons Processed for
Export Rules Related Notice, 11/18/82 (47 FR
51866).
PCB Disposal Permits 2
36
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Table 2A Detail Summary on NTP Studies and CHIPs
National Toxicology Program (NTP) Studies Reviewed
Sodium 2-ethylhexyl sulfate
Amosite asbestos
1,2-dichlorobenzene
Tremolite
Allyl isovajerate
toluene diisocyanate
geranyl acetate
2,6-xylidine
1,2-dichloropropane
1,1,1-trichloroethane
chlorobenzene
ethyl acrylate
2-chloro-l-methylethyl-(2-chloroprophyl) ether
propyl gallate bis
(2-chloro-l-methyl ethyl) ether
diallyl phthalate
Ziram
L-ascorbic acid
propylene
gilsonite
Monuron
propylene oxide
sodium fluoroscein
1,1,1,2-tetrachloroethane
4,4'-methylenedianiline
PBB mixture
Chemical Hazard Information Profiles (CHIPs) Prepared
C.I. Disperse Yellow, 3, 12/82
D and C Red No. 9, 12/82
Melamine, 12/82
Pentachloroethane, 1/83
iso-Butanol, 3/83
Chlorobenzotrichloride, 2/83
High Explosive, 2/83
n-Propanol, 3/83
Bis (2-chloro-1-methylethyl)
Acetaldehyde, 5/83
2,2'-Dithiobis(benzothiazole), 5/83
Tetrabromoethane, 5/83
Chloro-2-nitrobenzene, 6/83
Chloro-4-nitrobenzene, 6/83
Diaminoazobenzene, 6/83
Hexachloronorbornadiene, 8/83
2,3 Dichloro-p-dioxane, 8/83
Dimethylmethy phosphonate, 9/83
Propiontrile, 9/83
Ziram, 9/83
37
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Table 3
Date
Responses to Interagency Testing Committee (ITC)
Designations
Chemical Category
Action
ITC
List
10/12/82 Chlorendic Acid
11/01/82
11/08/82
12/16/82
12/16/82
12/29/82
12/29/82
Tris (2-chloroethyl)
phosphite
Final decision not to test; Release to the environment is
limited and such releases are unlikely to present an
unreasonable risk
Final decision not to test; available data indicate that
production and use result in little health risk and there is
no known release to the environment.
4-Chlorobenzotri floride Preliminary testing agreement; final negotiated testing
agreement- 7/18/83
Toluene Final decision not to test; ongoing health effects testing
will be sufficient to respond to ITC concern
Xylenes
Pyridine
Methyl Ethyl Ketone
Methyl Isobutyl Ketone
(2 substances)
12/29/82 Hexachlorobutadiene
12/29/82 Acetonitrile
12/29/82 Hexachlorocyclopenta-
dine
01/06/83 Acrylamide
01/06/83 Antimony Compounds
(3 compounds)
01/06/83 Isophorone
05/23/83 Formamide
05/23/83 Ethyltoluenes;
Trimethybenzenes and
C9 Aromatic
Hydrocarbon Fraction
(2 substances)
05/23/83 Biphenyl
07/05/83 Mesityl Oxide
07/11/83 Cresols
09/20/83 Methylenedianiline
Final decisions not to test; sufficient data have been
identified to characterize effects adequately
Proposed decision not to test
Preliminary testing agreement; final negotiated testing
agreement -9/30/83
Final decision not to test; not sufficient basis to find that
the current manufacture, distribution in commerce,
processing, use of disposal presents unreasonable risk
Proposed testing agreement negotiated with industry;
preliminary decision not to require testing
Final decision not to test; not sufficient basis to find that
the current manufacture, distribution in commerce,
processing, use of disposal presents unreasonable risk;
no substantial or significant human exposure or
environmental release; ongoing bioassay
Proposed testing agreement negotiated with industry;
preliminary decision not to require testing
Preliminary testing agreement; final negotiated testing
agreement - 9/26/83
Proposed testing agreement negotiated with industry;
preliminary decision not to require testing
Proposed testing agreement negotiated with industry;
ongoing government and industry testing is sufficient
Proposed health effects testing requirements
Proposed environmental effects testing requirements
Proposed health effects testing requirements
Proposed health effects testing requirements
Final decision not to test; ANPR for control action
9
1
1
2
4
4
4
2
4
4
10
10
&11
10
4
1
4
38
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•able
Region
1
2
3
4
5
6
7
8
9
10
HG
Total
4
Total No.
Complaints
Issued
in FY 79-83
17
100
36
27
185
82
51
45
28
21
4
596
Administrative Civil Actions Taken Under Section 16
of TSCA for Violations of PCB Regulations Complaints
Issued, Cases Completed, and Amounts Assessed (by
Regions)*
No.
Complaints
Issued
in FY 83
9
32
10
15
119
28
29
15
13
13
2
285
Total No.
Cases
Completed
FY 79-83
11
66
28
11
122
61
30
39
20
11
3
402
No. Cases
Completed**
in FY 83
5
23
11
8
86
21
16
15
10
6
2
203
Total
No. of
Cases
Pending
6
34
8
16
63
61
21
6
8
10
1
194
Total Civil
Penalty
Assessed
(in$) in FY83
56,503
195,230
58,325
36,970
500,784
148,930
77,700
77,800
74,450
17,960
120,000
1,364,652
Total Civil
Penalty
Amount
Assessed
(in$)
in FY 79-83
88,603
674,530
140,100
60,495
779,704
291,390
127,000
241,100
131,125
32,160
120,000
2,686,207
* All actions taken involved alleged violations of Section 6 PCB rules.
** Includes cases carried over from FY 80 FY 82.
39
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Table 5
State/Department Project Grant Descriptions and Status
TSCA Section 28 State Cooperative Agreements
Program
Amount($) Grant
Period
Illinois
Department of
Public Health
Maryland
Department of
Health and
Mental Hygiene
Maryland
Department of
Health and
Mental Hygiene
Michigan
Department of
Natural
Resources
Purpose: Develop an integrated voluntary system
detecting morbidity and mortality rates resulting from
exposure to toxic substances.
Current Status: Wrote and disseminated a brochure
and newsletter to State and local health officials and
medical professionals to explain the Environmental
Toxicology Program and obtain information on disease
clusters and trends in local communities. Follow-up
investigations are being conducted by the Department.
A guide and a questionnaire are being prepared to assist
in epidemiological investigations. State mortality and
birth data are being organized and computerized for
easier access. Cancer surveillance data from sixteen
countries are being completed. In one county, an
investigation of birth outcome and maternal history is
underway.
Purpose: Develop a computer based toxic substances
registry.
Current Status: The registry now contains information
on 250 chemicals, an incidents record, industrial survey
reports, all OSHA violations, and a record of all
occupationally related diseases. Maryland received a
no-cost extension to include birth defects data. The final
report has been received and distributed.
Purpose: Develop a program to assure the safe and
effective containment of toxic substances in storage
tanks.
Current Status: The contractor, the Ecology and
Environment Corporation, has drafted a guidance and
procedures manual. Seminars are being conducted.
Grantee received no-cost extension to December 1983.
475,626
March 81
to June
84
230,953
April 79
to April
83
100,000
March 81
to Decem-
ber83
Purpose: Develop an interdepartmental risk assessment
process.
Current Status: Many risk assessment models have
been reviewed and five major models selected for use
by the Departments of Natural Resources, Agriculture
and Public Health. Extensive environmental fate data
has been gathered by DNR on 90 priority chemicals
used or discharged in Michigan and 33 chemical
assessments have been completed. The Department of
Agriculture continues to sample and analyze for PCB's
and heavy metals. The Department of Public Health has
developed a computerized data system handling the
State's occupational health exposure data. The pesticide
toxaphene will be used to test the Michigan risk
assessment process. The grantee was granted a
no-cost extension to December 1983.
532,258
March 81
to Decem-
ber 83
40
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State/Department
Michigan
Department of
Natural
Resources
Project Grant Descriptions and Status
Purpose: Critical Materials Program
Current Status: This project has been
final report was received and summary
completed. The
distributed.
Amount($)
504,500
Grant
Period
April 79
to Sept.
82
New Jersey
Department of
Environmental
Protection
Purpose: Set up a toxic substances investigation and
integration unit; expand current project monitoring
volatile organic compounds in air.
Current Status: Toxic Substances Investigation and
Integration Unit has identified and investigated various
hazardous waste sites in New Jersey. Cancer and birth
defects clusters are being investigated. The mobile
monitoring van is completed and is currently operating
throughout the State. A final report is being completed.
453,947
April 79
to April
84
New Jersey
Department of
Environmental
Protection
New York
Department of
Environmental
Conservation
Purpose: Study movement, distribution and uptake of 794,053
in-place mercury; monitor emissions of selected toxic
substances; assess the ecological effects of water
contaminants; establish and operate a Toxic Substances
Information Resources Center; conduct a field
application study of in vitro mutagenesis tests.
Current Status: Additional sampling of biota has been
collected and analyzed for mercury and other heavy
metals. Methods and resources required for sampling
and analysis of various environmental emissions from
selected groups of facilities have been identified and
field tested. Research on the effects of environmental
stress in aquatic organisms continues. Summary reports
of toxic substances research have been prepared along
with other educational materials. Waste water samples
have been assayed for mutagenic activity using the
Ames test. New Jersey was granted a no-cost
extension from May 1983 to April 30, 1984.
Purpose: Identify, characterize and plan for managing 348,000
toxic substances.
Current Status: The grantee proposed to use New
York's experience in the Niagara River Project as the
basis for a Statewide management plan. This proposal is
being revised to include the State's experience in
projects other than the Niagra River, and abstract from
that project only those characteristics that can be
reasonably expected to be applicable to other sites
around the State. In order to carry this out effectively,
the grantee has received a no-cost extension to June
30, 1984.
March 80
to April
84
April 79
to June
84
North Carolina Purpose: Identify, assess and plan to control toxic
Office Natural substances by profiling substances; identifying sources,
Resources level and duration of exposures; and developing a plan
to control toxic substances posing an unreasonable risk.
Current Status: The project has been completed; a
grant extension has enabled North Carolina to complete
51 chemical guides which have been distributed.
385,000
March 80
to
December
83
Puerto Rico Purpose: Develop and manage the Commonwealth's.
Environmental toxic substances management strategy; expand an
Quality Board existing public participation/ awareness program.
258,394
March 80
to
October
83
41
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State/Department Project Grant Descriptions and Status Amount($) [?ra.n*.
Current Status: Developed and sponsored a meeting
for the Inter-Agency Advisory Committee on Toxic
Substances Control. Prepared a questionnaire on PCBs
for the industrial plants in Puerto Rico and planned
inspection visits. An extension until October 31, 1983
was granted to implement part of the strategy.
Wisconsin Purpose: Study health problems related to 202,947 April 79
Department formaldehyde vapors from mobile home construction to
Social Sciences materials. September
82
Current Status: This study is complete. The final report
was received and distributed.
42
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Appendix A Summary/Guide to Information Required by Congress
Section 30, 28(c), and 9(d) of TSCA require that certain
information be reported each year to the President and
Congress. To assist readers in locating this information, a
summary of each pertinent TSCA action and reference to
a more detailed explanation, within this report, is given
here.
Section 30. This section contains the basic requirement
for an Annual Report and requests the following
information:
(1) Testing. In FY'83, EPA proposed four negotiated
testing agreements and finalized six. (See Table 3.) The
Agency published seven decisions not to test and one
proposed decision not to test. This proposed decision
sought additional public comment on the chemical of
concern. In addition, on July 19, 1983 a final Section 4(c)
TSCA data reimbursement rule was promulgated. See
Section 5.
(2) Premanufacture Notices (PMN). EPA received 1301
PMNs during FY'83 bringing the total received since the
program's beginning in mid-1979 to 3012. (None of these
chemicals were subject to rulemaking under Section 4). In
approximately 36 cases, voluntary testing or control
activities took place in FY'83, while 27 chemicals were
subject to the development of either a Section 5(e) or 5(f)
order. See Section 3, Program Status and Table 1.
(3) Rules Issued Under Section 6. During FY'83, four rules
were promulgated regarding PCBs. On October 21, 1982,
a final rule was published regarding PCBs in releases from
closed and controlled waste processes. On January 3,
1983, a final rule was published regarding use
authorization for PCB railroad transformers. On February
8, 1983, a final rule was published which served to update
analytical test methodology. On March 30, 1983 a
procedural rule was issued regarding approval authority for
PCB disposal facilities. See Section 4, PCBs.
Advance Notices of Proposed Rulemaking were issued for
two chemicals. Methylene bis (2-chloroaniline) (MBOCA)
and 4,4'-methylenedianiline (MDA). MBOCA is used as a
curing agent in the polyurethane plastics industry.
4,4'-MDA is a high production chemical used primarily as
an intermediate to make other chemicals and plastics and
poses a serious carcinogenic potential in the workplace
(See Section 4, MBOCA and 4,4'-MDA.)
(4) Judical Actions Under TSCA and Administrative Actions
Under Section 16. All judicial actions concern PCBs except
43
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one which concerns formaldehyde. In FY'83 three suits
were filed, one petition to review rulemaking was filed,
two suits were dismissed, one suit is pending and three
suits were settled, including the suit regarding
formaldehyde. (See Section 7, Litigation, for details.)
A total of 203 PCB civil enforcement cases were
completed in FY'83. A total of 194 PCB cases are
pending. See full discussion in Section 6, Enforcement.
(5) Major Problems. No major problems were encountered
in FY'83 in-administering TSCA.
(6) Recommended Legislation. No legislative changes are
sought at this time.
Section 28(c). This section requires a report on grants to
States during the year. Four State cooperative agreement
projects were completed in FY'83. These were
undertaken by Michigan, Wisconsin, Maryland and North
Carolina. Seven additional State grants are due to be
completed in 1983 and 1984. See description of projects
in Section 8, State Programs.
Section 9(d). This section requires that EPA's efforts to
coordinate its TSCA activities with related activities of
other Federal activities be reported annually.
During FY'83, EPA continued in several formal and
informal agreements with other Federal government
programs concerning specific chemical activities. These
include a Federal Asbestos Task Force of which OSHA,
CPSC, EPA are charter members. Others have been
invited to join — Mine Safety and Health Administration,
Food and Drug Administration, National Institute for
Occupational Safety and Health, National Institute for
Environmental Health Sciences, and the National Cancer
Institute. In addition EPA, in conjunction with the CPSC,
published a technical guidance booklet on asbestos in the
home. A joint ANPR on the chemical 4,4'-MDA was
coordinated with the Occupational Safety and Health
Administration. Other areas include information exchange
under Section 8(e) and work with several international
organizations. Details on these activities appear in
appropriate sections of the report.
44
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Appendix B
Major FY'83 TSCA Actions
Section Description
of Law
Date
4(a) For Listing of Testing Decisions see Table 3
4(b) Testing Guidelines Published 9/22/83
4(c) TSCA Data Reimbursement Final Rule 7/19/83
4(f) 4,4'-Methylenedianiline 4/18/83
5(a) Potassuim N,N-Bis (Hydroxyethyl) Cocoamine 2/17/83
Oxide Phosphate and Potassuim N,N-Bis
(Hydroxyethyl) Tallowamine Oxide Phosphate
Proposed Significant New Use Rule
Chlorinated Naphthalenes Proposed 5/06/83
Significant New Use Rule
1 Sopropylamine, Distillation, Residues, and 8/24/83
Etylamine, DistillationResidues
1,2 Benzenediamine, 4-Ethoxy, Sulfate 8/30/83
Proposed Significant New Use Rule
5(e) Consent Order; Halogenated Hydrocarbon 1/20/83
Established use of protective equipment
Consent Order; Substituted Phenol, 3/09/83
Substituted Pyridine, Sodium 2-Substituted
Proponate Requires use of dermal
protection for all of the substances, and
positive pressure, full facepiece air-supplied
respirators
Consent'Order; Substituted Pyridine 4/04/83
Requires use of safety equipment and
processing controls at manufacturing and
processing sites
Consent Order; Discarboxylic Acid 4/18/83
Monoester Requires use of protective
equipment during processing, application of a
label, and a written notice to all workers who
may be exposed
Consent Order; Shale-Derived Syncrude 5/25/83
Restricts production volume, worker
exposure controls and waste handling
pending development of sufficient
information
Order; Two Chlorinated Azo Pigments - 6/23/83
Possible carcinogenic effects
Proposed Order; Dyes for Fibers and Fabrics 7/19/83
Possible carcinogenic effects
Consent Order; Polyglycidyl amine Restricts 8/16/83
manufacturing processing and distribution in
commerce and use
Consent Order; 8-acetyl 3-dodecyl 7,7,9, 9/02/83
9-tetramethyl 1,3,8-triazaspiro decane
2,4-diane, Prohibits demestic manufacture
45
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and requires workers to use protective
equipment during processing. Requires
precautionary labels to be affixed to all
containers of PMN substances that are
distributed.
Consent Order; Substituted Nitrile Limits 9/29/83
production to six months pending develop-
ment of neurotoxicity and aquatic toxicity
testing. Dumping of waste is not permitted
until completion of aquatic toxicity text
6(a) Methylene Bis, Advance Notice of Proposed 5/23/83
Rulemaking
4,4'-Methylenedianiline, Advance Notice of 9/20/83
Proposed Rulemaking
6(e) Polychlorinated Biphenyls (PCBs); 10/21/82
Manufacturer, Processing Distribution, and
Use in Closed and Controlled Waste
Manufactured Processes (Final Rule)
Polychlorinated Bipheny|s (PCBs); Use 1/03/83
Authorization for PCB Disposal Facilities
(Final Rule)
Polychlorinated Biphenyls (PCBs); 2/08/83
Manufacturing, Processing, Distribution in
Commerce, and Use Prohibitions;
Incorporation by Reference Revisions
(Updating Analytical Test Methodology) (Final
Rule)
Polychorinated Biphenyls (PCBs); Approval 3/30/83
authority for PCB Disposal Facilities (Final
Rule)
8(a) Chlorinated Terphenyl Submission of Notice 4/29/83
of Manufacture or Importation (Proposed
Rule)
Preliminary Assessment Information 5/19/83
Amendment to Include the 6th 9th ITC Lists
(Final Rule)
Preliminary Assessment Information 5/19/83
Amendment to Include the 11th ITC List
(Proposed Rule)
Amendment to Add the 12 ITC List to the 6/22/83
8(a) Preliminary Assessment Information Rule
(Final Rule)
8(a) Amendments Rule, Automatic Update (Final 5/11/83
Level A Rule)
8(c) Significant Adverse Reaction to Health and 8/22/83
Environment
8(d) Health and Safety Data Reporting 12/03/82
Amendment to include 11th ITC List (Final
Rule)
Health and Safety Data Reporting 3/30/83
Amendment to Include Chemicals
Designated in the 6th 10th ITC Lists (Final
Rule)
Amendment to Add 12th ITC List to 8(d) Rule 6/01/83
(Final Rule)
46
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