United States        January 1984
            Environmental Protection
            Washington DC 20460
&EPA      Toxic Substances
            Control Act (TSCA)

            Report to Congress
            for Fiscal Year 1983

Toxic Substances
Control Act (TSCA)
Report to
for Fiscal Year 1983
 Prepared by:
 U. S. Environmental Protection Agency
 Washington, DC 20460
January, 1984

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

  1. Summary of New Chemical Actions

  2. Summary of Existing Chemical Actions

  2A. Detail  Summary on National Toxicology Program Studies and
  3. EPA Response to Interagency Testing Committee (ITC)

  4. Administrative Civil Actions Taken Under Section  16 of TSCA

  5. TSCA Section 28
  Appendix A - Summary/Guide to Information Required by
  Congress (Section 9(d), 28(c) and 30)

  Appendix B - Major FY'83 TSCA Actions

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

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.

                   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.

  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

                    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
                      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

                     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.

                       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
                      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

                     PCB containers and for improper disposal of PCB material.
                     FY'83 also saw the first imposition of major fines for PMN
                       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.

                    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
                      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

                     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

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
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.

                       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.

                    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
                      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

                     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

                    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.
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

                      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,


                      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.

  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
  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.


 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

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
  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

                    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
                      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.

                   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

                     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.
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.
ment of
Testing Costs
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.

                     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

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

                     provide data for use by EPA in developing policy and
                     guidance to support a continuing and expanded
                     cooperative enforcement program with the States.

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

                       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'

                     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.

  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
  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

                     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,

                     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

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.

Aluminum Company of America v. EPA (No. 79-1811,  D.C.

                     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.

Table 1
Summary of New Chemical Actions
October 1, 1982 - September 30, 1983
Valid PMNs Received
Voluntary Testing in Response to EPA
Voluntary Control Actions by
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
No. of PMN
                      * This number includes 106 synfuels

                      ** This number includes PMNs received in previous fiscal years for which notices
                      were received in FY'83.

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
                        Central Michigan petition for an investigation of
                        dioxin and furan pollution; denied, 7/25/83 (48 FR

                      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)

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).

                       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

                       PCB Disposal Permits                                      2

Table 2A            Detail Summary on NTP Studies and CHIPs

                       National Toxicology Program (NTP) Studies Reviewed
                       Sodium 2-ethylhexyl sulfate
                       Amosite asbestos
                       Allyl isovajerate
                       toluene diisocyanate
                       geranyl acetate
                       ethyl acrylate
                       2-chloro-l-methylethyl-(2-chloroprophyl) ether
                       propyl gallate bis
                       (2-chloro-l-methyl ethyl) ether
                       diallyl phthalate
                       L-ascorbic acid
                       propylene oxide
                       sodium fluoroscein
                       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

 Table  3
              Responses to Interagency Testing Committee (ITC)
Chemical Category
  10/12/82    Chlorendic Acid





Tris (2-chloroethyl)
  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


Methyl Ethyl Ketone
Methyl Isobutyl Ketone
(2 substances)
  12/29/82   Hexachlorobutadiene
  12/29/82   Acetonitrile
  12/29/82   Hexachlorocyclopenta-
  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













Total No.
in FY 79-83
Administrative Civil Actions Taken Under Section 16
of TSCA for Violations of PCB Regulations Complaints
Issued, Cases Completed, and Amounts Assessed (by
in FY 83
Total No.
FY 79-83
No. Cases
in FY 83
No. of
Total Civil
(in$) in FY83
Total Civil
in FY 79-83
* All actions taken involved alleged violations of Section 6 PCB rules.
** Includes cases carried over from FY 80  FY 82.

Table 5

 State/Department Project Grant Descriptions and Status
        TSCA Section 28 State Cooperative Agreements
                                                  Amount($)   Grant
 Department of
 Public Health
 Department of
 Health and
 Mental Hygiene
 Department of
 Health and
 Mental Hygiene
 Department of
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

Purpose: Develop a computer based toxic substances
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
                 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.
March 81
to June
April 79
to April
March 81
to Decem-
                 Purpose: Develop an interdepartmental risk assessment

                 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.
          March 81
          to Decem-
          ber 83

Department of
Project Grant Descriptions and Status
Purpose: Critical Materials Program
Current Status: This project has been
final report was received and summary

completed. The
April 79
to Sept.
New Jersey
Department of
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.
April 79
to April
New Jersey
Department of
 New York
 Department of
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
          April 79
          to June
 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.
          March 80
Puerto Rico      Purpose: Develop and manage the Commonwealth's.
Environmental    toxic substances management strategy; expand an
Quality Board     existing public participation/ awareness program.
          March 80

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

                 Current Status: This  study is complete. The final report
                 was received and distributed.

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

                   Section 30. This section contains the basic requirement
                   for an Annual Report and requests the following

                   (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

                     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.

Appendix B
Major FY'83 TSCA Actions

Section  Description
of Law
                      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

                               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

                               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

                       and requires workers to use protective
                       equipment during processing. Requires
                       precautionary labels to be affixed to all
                       containers of PMN substances that are
                       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
                       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
                       Polychorinated Biphenyls (PCBs); Approval     3/30/83
                       authority for PCB Disposal Facilities  (Final
               8(a)     Chlorinated Terphenyl  Submission of Notice   4/29/83
                       of Manufacture or Importation (Proposed
                       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
               8(d)     Health and Safety Data Reporting              12/03/82
                       Amendment to include 11th  ITC List (Final
                       Health and Safety Data Reporting              3/30/83
                       Amendment to Include Chemicals
                       Designated in the 6th  10th ITC Lists (Final
                       Amendment to Add 12th ITC List to 8(d) Rule  6/01/83
                       (Final Rule)