United States January 1985
Environmental Protection Agency
Washington DC 20460
c/EPA Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1984
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Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1984
Prepared
U.S. Environmental Protection Agency
Washington, D.C. 20460
January 1985
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Contents
Abbreviations iv
1. Introduction 1
2. Highlights of the Year 2
Program Implementation 2
New Chemicals Review 2
Existing Chemicals 3
International Activities 5
Enforcement 5
Indemnification Report to Congress 5
3. New Chemicals 7
Program Status 7
Exemptions 9
Biotechnology 10
Followup Program 11
4. Existing Chemicals 13
Program Status 13
Information-gathering 13
Chemical Testing 13
Reporting and Recordkeeping 17
Monitoring 18
Risk Evaluation 18
Chemical Hazard Information Profiles 19
TSCA Section 21 Petitions 20
Risk Management 20
Chemical Advisories 24
TSCA Section 9 and Workplace Referrals 26
5. Quality of Data 27
Test Guidelines 27
Good Laboratory Practices 28
6. Toxics Integration 29
Databases .29
Chemical Strategies 30
Coordination Activities 31
Other Activities 31
7. Compliance and Enforcement 33
Program Actions 33
Compliance Actions 33
Civil Enforcement Actions 34
8. Litigation 35
9. State Programs 39
10. International Activities 41
Importing Chemicals 43
n
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Tables
1. Summary of New Chemical Actions,
October 1, 1983 - September 30, 1984 8
2. Responses to Interagency Testing Committee
Designations 15
3. Summary of Existing Chemical Actions 19
4. Administrative Civil Actions Taken under section
16 of TSCA, Complaints Issued, Cases Completed,
and Amounts Assessed (by Regions) 34
Appendices
A. Summary/Guide to Information Required bv
Congress 44
B. Major FY 1984 TSCA Actions 46
C. Section 4 Test Studies Received 53
D. Summary of NTP Studies 53
E. Chemical Hazard Information Profiles(CHIPs)
Prepared r 54
F. FY 1984 section 21 Citizens' Petitions 55
G. TSCA section 28 Cooperative Agreements Program 56
in
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Abbreviations
ANPR Advance Notice of Proposed Rulemaking
CHIP Chemical Hazard Information Profile
CPSC Consumer Product Safety Commission
DOL Department of Labor
EAR Extramural Activity Report
EPA U.S. Environmental Protection Agency
EPACASR EPA Chemical Activities Status Report
FDA Food and Drug Administration
GLP Good Laboratory Practice
IFIS Industry File Information System
IPP Intermedia Priority Pollutant (document)
I PCS International Program on Chemical Safety
IRMC Inter-Regulatory Risk Management Council
IRPTC International Register of Potentially Toxic
Chemicals
ITC Interagency Testing Committee
MOU Memorandum of Understanding
NIOSH National Institute for Occupational Safety and
Health
NTA Negotiated Testing Agreement
NTIS National Technical Information Service
NTP National Toxicology Program
OECD Organization for Economic Cooperation and
Development
ORD Office of Research and Development
OSHA Occupational Safety and Health Administration
OTS Office of Toxic Substances
PCB Polychlorinated biphenyl
PMN Premanufacture notification
ppm Parts-per-million
SEIU Service Employees International Union
SNUR Significant New Use Rule
TSCA Toxic Substances Control Act
UNEP United Nations Environment Program
WHO World Health Organization
IV
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1
Introduction
The Toxic Substances Control Act (TSCA) was enacted by
Congress to protect human health and the environment
from unreasonable risks. Virtually all of the provisions of
the Act have been implemented. Programs are now
operating under the Act to review and regulate new
chemicals, where necessary; to gather information about
the toxicity of specific chemicals and the extent to which
people and the environment are exposed to them; to
bring about industry testing where existing data are
inadequate; to assess whether particular chemicals cause
unreasonable risks to humans or the environment; and to
institute appropriate control actions after carefully
weighing the risks against the benefits to the nation's
economic and social well-being provided by specific
chemicals.
To help ensure informed decisionmaking by the
government, TSCA gives the Environmental Protection
Agency (EPA) authority to gather basic information on
certain chemicals from manufacturers, processors and
distributors. The law enables EPA to require companies to
test chemicals to obtain data needed to evaluate their
risks and stipulates that companies are to submit to EPA
certain specified information on all new chemicals before
they are manufactured. To prevent unreasonable risks,
EPA, under TSCA, may select from a broad range of
control actions, from requiring hazard-warning labels to
outright bans on the manufacture or use of substances
that present unreasonable risks at any stage in a
chemical's life-cycle: in manufacturing, processing,
distribution in commerce, use or disposal.
This seventh annual report to Congress summarizes the
progress EPA has made in implementing the Act during
FY 1984. It fulfills the Congressional reporting
requirements of TSCA sections 9(d), 28(c), and 30 and
highlights significant programs and Agency progress in
achieving a high level of health and environmental quality
in FY 1984 (see Appendices A and B).
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2
Highlights of the Year
Proqram
Implemen-
tation
New
Chemicals
Review
FY 1984 saw EPA refine and focus its activities to more
effectively carry out the Act. EPA reviewed and, where
necessary, regulated new chemicals more proficiently;
followed selected new chemicals as they matured in the
marketplace; used a wide range of regulatory and
non-regulatory tools to gather and disseminate information
on the risks of specific chemicals; initiated rulemaking to
control unreasonable risks from certain chemicals;
identified several chemicals as likely section 9 referral
candidates to other agencies; finalized other rules;
integrated the new and existing chemicals programs more
effectively; stepped up enforcement of the Act; and
intensified its program to assure the quality of tests that
are performed for TSCA purposes.
EPA's new chemicals program matured during FY 1984.
The Agency received about 1,200 Premanufacture Notices
(PMNs), which is comparable to the number received in
FY 1983. The final PMN rule, which became effective
early in FY 1984, established uniform requirements for
PMN reporting and recordkeeping. EPA issued more
orders under section 5(e), controlling exposure pending
the development of necessary data, than in any other
year.
FY 1984 saw the first use of section 5(f) by the Agency
to prevent the formation of potentially cancer-causing
nitrosamines from certain new metalworking fluids. Since
similar existing metalworking fluids present similar
concerns, EPA is addressing them by advising
metalworking fluid formulators and users of their potential
hazards and of ways to avoid these hazards in parallel
with investigating the need for a regulation to prohibit
certain formulations that produce nitrosamines. This is an
excellent example of the close interplay between EPA's
new and existing chemical activities.
FY 1984 also marked the issuance of the first final
Significant New Use Rule (SNUR), which extended the
requirements of a section 5(e) order to other
manufacturers and processors of the specified chemical,
who could have otherwise made or processed the
chemical without the restrictions placed on the original
PMN submitter.
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FY 1984 also saw EPA lay the foundation for addressing
what may be its most challenging emerging new
chemicals issue; biotechnology. United States industry is
an international leader in biotechnology development, and
EPA is dedicated to protecting health and the environment
without unduly impeding innovation. Two major activities
occurred in FY 1984; first, EPA participated in a Cabinet
Council activity to coordinate all Federal biotechnology
activity. Second, EPA drafted a preliminary policy
statement on biotechnology. This document was
published for comment in December, 1984.
Existing The evaluation and control (where needed) of existing
Chemicals chemicals were high priorities in FY 1984. EPA adopted a
flexible approach, making full use of TSCA's regulatory
and non-regulatory tools to gather and disseminate
important risk information and to control or take steps to
control unreasonable risks.
EPA used a wide variety of information-gathering tools
in FY 1984. The Agency signed its first Final Test Rule
under section 4 on 1,1,1-trichloroethane. EPA responded
to certain of the new designations of the Interagency
Testing Committee (ITC) with decisions not to test
because agreement had already been reached with
industry to undertake voluntary testing programs. These
agreements are known as Negotiated Testing Agreements
(NTAs). In a number of instances, similar dispositions
were made for the backlog of fourteen ITC chemicals. In
all, NTAs played a major role in FY 1984; 162 tests were
received and 14 new NTAs were entered into. However, a
decision of the District Court for the Southern District of
New York, entered on August 23, 1984, indicated that
EPA may no longer respond to ITC designations through
NTAs. As a result, EPA will need to reevaluate its section
4 testing program in FY 1985. In addition, EPA also
covered 75 chemicals in proposed and final section 8
rules in FY 1984.
In addition, EPA performs monitoring studies to gather
information on human exposures. The National Human
Adipose Tissue Survey (Adipose Survey) is a good
example. Valuable information such as the decline of
pplychlorinated biphenyls (PCBs) in human tissues and the
high levels of hexachlorobenzene (HCB) helps EPA to
evaluate the effectiveness of its regulations and to target
future activities. As a complement to the Adipose Survey,
EPA is considering establishment of a pilot program for a
National Blood Network Survey (Blood Survey) to
determine the prevalence and levels of toxic substances
in human blood.
3.
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EPA completed review of 27 chemicals in FY 1984 to
see if regulatory action was needed. Another 52
chemicals are undergoing review. EPA accorded high-
priority review under section 4(f) to two chemicals in FY
1984. The first was 1,3-butadiene, an important reactant
in producing synthetic rubber products, which caused a
high incidence of cancer in laboratory animals. The other
chemical was formaldehyde, which also caused cancer in
laboratory animals. The Agency gave high-priority review
to formaldehyde exposures in mobile and conventional
homes, as well as to apparel workers. EPA also issued
Advance Notices of Proposed Rulemaking (ANPRs) on the
section 4(f) uses of both formaldehyde and 1,3-butadiene.
In addition, an ANPR was issued for certain glycol ethers
that have been widely used as solvents and are
associated with certain birth and reproductive effects.
EPA was especially concerned about their consumer and
trade uses.
EPA was active in issuing regulations on PCBs in FY
1984. Three final rules were promulgated. The first rule
set a numerical cut-off for the inadvertent generation of
PCBs. The second rule took action on 109 exemption
requests from the ban of PCBs. The third rule established
certain uses for small quantities of PCBs in research and
development. The Agency also issued both an ANPR and
a proposed rule based on the potential risks associated
with PCB transformer fires.
FY 1984 marked EPA's first use of Chemical Advisories.
These Advisories are not rules; rather, they inform
relevant audiences about the hazards that specific
chemicals present, and provide practical steps to minimize
or eliminate those hazards. The first advisory covered
used motor oil handled by service station workers, engine
mechanics, and other workers. Used motor oil causes
skin cancer in laboratory animals. Two other Advisories
were issued on certain cutting fluids which could form
nitrosamines, a class of potential human carcinogens. One
advisory was directed at formulators, the other at end
users, the Agency also issued a Chemical Advisory on
leaking underground storage tanks to raise the awareness
of storage tank owners regarding possible leaks, and to
help them determine whether their own tanks are leaking.
Asbestos was a high priority for EPA in FY 1984. The
ongoing technical assistance program for schools and
other buildings was expanded. A recent survey suggests
that the technical assistance program has been effective;
most schools that have found asbestos have either
initiated or completed abatement. In FY 1984, the Agency
announced plans to establish three pilot centers to
provide information and training on identifying and abating
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International
Activities
Enforcement
Indemnifi-
cation Report
to Congress
asbestos hazards in schools and other buildings, and to
establish a model state contractor certification program to
ensure that abatement work is performed correctly and
safely. Late FY 1984 saw the enactment of the Asbestos
School Hazard Abatement Act, which provides limited
funds in loans and grants for asbestos abatement
activities in schools. EPA drafted application forms and
established a preliminary implementation plan in FY 1984.
EPA plans to provide $45 million in financial aid by June
1985.
FY 1984 was also an active year internationally. In April,
the United States and the Organization for Economic
Cooperation and Development (OECD) members agreed
that before any banned or severely restricted chemicals
are exported, the exporting country will notify the
receiving country. This agreement, which is modeled after
section 12(b) of TSCA, affords receiving countries the
opportunity to rationally determine how to deal with such
chemicals. In March of FY 1984, the OECD, with input
from EPA, agreed on the issues they will address through
1987. Some of the more significant issues are exchange
of confidential information, compliance with Good
Laboratory Practices (GLPs), and hazard assessment
methods.
In FY 1984, EPA stepped up its compliance activities
under TSCA. The number of inspections more than
doubled from FY 1983. In FY 1983, EPA inspections
focused primarily on PCB compliance. While the PCB
issue was still important in FY 1984, EPA emphasized
compliance with other TSCA requirements as well. The
bulk of the inspections were on PCBs (nearly 1,500), on
asbestos-in-schools (nearly 2,000), and on the Chemical
Substances Importer Rule (nearly 500). In addition, there
were over 200 inspections on new chemicals, more than
150 inspections for compliance with reporting and
recordkeeping under TSCA section 8, and nearly 50
laboratories were inspected for compliance with GLPs.
Enforcement was also emphasized. Eighty-two civil
complaints were issued for alleged violation of the
asbestos-in-schools rule; these are the first complaints
issued by EPA under this rule.
Under section 25 (a) of TSCA, EPA is required to conduct
a study to determine whether and under what conditions,
if any, indemnification should be accorded any person as a
result of any action taken by the Administrator under
Federal laws administered by EPA. On February 3, 1984,
the Administrator sent the Indemnification Report to
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Congress. The report concluded that there is no
justification for expanding the existing indemnification
programs at EPA nor for creating new programs because
there are very few actual uncompensated losses. Many
potential losses are prevented, reduced, or shifted by
administrative action. Other losses are compensable
under the Federal Tort Claims Act. the Tucker Act, or the
Equal Access to Justice Act.
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3
New Chemicals
Program Under section 5 of TSCA, EPA is responsible for
Status reviewing new chemicals prior to manufacture or import.
For purposes of premanufacture review under TSCA,
"new" chemicals are those not listed on the TSCA
Chemical Substances Inventory. This inventory of existing
chemicals is EPA's comprehensive list of chemical
substances in commerce. Under section 5(a),
manufacturers must provide 90-day notification to the
Agency, through the PMN.
Regulations written under section 5 also require a
manufacturer to submit a Notice of Commencement of
Manufacture, after an EPA review of the PMN is
completed and prior to the actual start of manufacture.
This notice is given when the manufacturer actually
begins producing the substance. It is at this point that a
new chemical is added to the TSCA Chemical Substances
Inventory. TSCA also authorizes EPA to track new
chemicals that might be of concern if their uses change,
or if production volume increases after initial PMN review.
EPA continued to make significant strides in FY 1984 to
further refine the PMN review process, develop
appropriate analytical methods for reviewing new
chemicals, perform reviews quickly and, where necessary,
regulate new chemicals. With standardized procedures
and a submission form required by the PMN rule, which
became effective in October 1983, and with EPA's
accumulated experience in new chemical review, the
PMN program has evolved into a very effective
mechanism for identifying problems and managing risks.
The PMN rule was a major milestone for the new
chemical review program and represented the culmination
of several years of effort to create effective, standard
procedures for PMN reporting and recordkeeping. In
addition to ensuring consistent enforcement of section 5
provisions, procedures under the final rule enable EPA to
review the large number of PMN submissions the Agency
is receiving. EPA received close to 1,200 PMNs in FY
1984, bringing the total received since the inception of the
program to over 4,200. Most of the new chemicals
reviewed under this preventive program did not require
regulatory action. Wherever necessary, however, the
Agency took appropriate action according to several
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regulatory options available under section 5 of TSCA. EPA
issued PMNs affected by 5(e) orders prohibiting or
controlling 41 PMNs pending the development of data,
bringing the aggregate total of PMNs affected by 5(e)
orders issued since 1979 to 173. In addition, 35 PMNs
were withdrawn by their submitters in FY 1984, in
anticipation of EPA action under sections 5(e) or 5(f).
Table 1 summarizes new chemical actions taken in FY
1984, and also gives aggregate totals since 1979.
Table 1
Summary of New Chemical Actions
October 1, 1983-September 30,1984
Aggregated
tal Si
Actions
No. of
PMN Total Since
Actions Beginning
in FY'84 (mid-1979)
Submission of Bona Fide Intent to Manufacture
Valid PMNs Received
PMNs Requiring No Further Action
Voluntary Testing in Response to EPA Concerns
Voluntary Control Actions by Submitters
PMNs Voluntarily Withdrawn in Light of EPA Concern
PMNs Subject to section 5(e) Consent Orders*
PMN Unilateral 5(e) Orders*
PMNs Subject to section 5(f) Rules
Number of Chemicals for which Commencement of Manufacture
Notices Were Received
New Chemicals Subject to Proposed Significant New Use Rules
New Chemicals Subject to Final Significant New Use Rule
Valid Test Market Exemptions
Received
Granted
Granted with modification
Withdrawn
Denied
530
1,192
936
20
4
35
40
1
4
584**
18***
o***
80
67
10
3
0
1,517
4,201a
3,452
. 78
37
59
173a
14
4
1,830**
23****
2
313
276
10
18
9
a Includes 106 syn fuels.
*A consent 5(e) order is issued by EPA with the agreement of the PMN
submitter. A unilateral 5(e) order is issued by EPA without the
agreement of the PMN submitter.
**This number includes PMNs received in previous fiscal years for
which commencement of manufacture notices were received in FY
1984.
***This number includes chemicals which were the subjects of PMNs
received in previous fiscal years, but for which proposed or final rules
were not published until FY 1984.
****This number excludes seven chemicals that were subject to SNUB
proposals, but for which the PMNs were subsequently withdrawn
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In FY 1984, the Agency implemented aggressive
approaches to obtain additional information on PMN
chemicals which were suspected of presenting
unreasonable risks and to control exposures to these
chemicals. TSCA section 5(e) orders placed controls on
more PMN chemicals pending development of needed
data in that year than in any other year. One innovative
approach to systematically gathering needed data was to
establish "delayed trigger" TSCA 5(e) orders which
required submission of test data before production could
exceed a specified production volume or time period. In
this way, the Agency can receive needed data without
unduly impeding innovation.
FY 1984 saw the first use of section 5(f) by the Agency.
Section 5(f) authorizes EPA to issue an immediately
effective rule to control new chemicals that present an
unreasonable risk to health or the environment. The first
immediately effective section 5(f) rule, issued January 23,
1984, applied to: (1) the substance known generically as
the triethanolamine salt of tricarboxylic acid, intended for
use as a ferrous metal corrosion inhibitor in metalworking
fluid concentrates, and in hydraulic fluids; and (2) an
intermediate used in the formulation of the corrosion
inhibitor. Under certain circumstances, this chemical
would produce N-nitrosodiethanolamine (NDELA), a
nitrosamine which causes cancer in laboratory animals.
The rule prohibited the practices that lead to the formation
of NDELA and required distributors to notify customers of
this restriction. Two similar rules were issued in June and
September, 1984.
Exemptions EPA may grant exemptions from full PMN review for
substances produced for test marketing if the substances
do not present an unreasonable risk to health or the
environment. These exemptions are limited to the time
necessary to complete test marketing. If the chemical is
marketed for further commercial purposes, a PMN would
be required. During FY 1984, 80 test market exemptions
were received, 77 were granted (10 with modification),
none were denied, and 3 were withdrawn in the face of
EPA concerns. EPA places upon the submitter the burden
of establishing the finding that an unreasonable risk does
not exist. If the data submitted in the test market
exemption application do not establish this finding, the
application is not granted.
Section 5(h)(4) authorizes EPA to exempt chemicals
from the PMN process if the Agency finds that such
chemicals will not present an unreasonable risk of injury
to health or the environment. In response to petitions
from the Chemical Manufacturers Association and other
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industry trade groups, EPA evaluated certain chemicals
and categories of chemicals as candidates for exemptions.
In 1982, EPA published proposed rules to partially exempt
from the PMN requirements certain polymers, site-limited
intermediates (chemicals that react to form other
chemicals at their site of manufacture), and chemicals
produced in low volume (less than 10,000 kg/yr).
After reviewing public comments, in FY 1984 EPA
decided to postpone promulgation of the site-limited/low
volume exemption rule, and to develop a final polymer
exemption rule. Under this rule, polymers with a
number-average molecular weight greater than 1,000, and
polyesters manufactured solely from a list of approved
reactants would be eligible for an accelerated (21-day)
PMN review. Certain categories of polymers are excluded
from the exemption. The final polymer exemption rule is
currently being reviewed and is expected to be
promulgated in early FY 1985. The Agency is also
developing the low-volume exemption rule for
promulgation in FY 1985.
Biotechnology Perhaps the greatest emerging challenge for the New
Chemicals Program in FY 1984 was addressing the rapidly
advancing biotechnology industry. United States industry
is an international leader in the development of this
technology, which clearly has the potential for
revolutionary new applications in the near future. EPA is
committed to fostering the development of beneficial
uses of biotechnology while protecting human health and
the environment from unreasonable risk. Biotechnology
promises great benefits for the United States and the
international economy in areas including pollution
abatement, agriculture, energy, and Pharmaceuticals. At
the same time, biotechnological products present unique
regulatory challenges.
During FY 1984, the Agency developed a policy
statement to clarify the applicability of TSCA and the
Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) to new microorganisms produced through
biotechnology and used for commercial purposes. This
statement describes EPA's plan for reviewing microbial
products and solicits comments on a wide range of
science and policy issues. It was published, along with
similar statements by the Department of Agriculture and
the Food and Drug Administration (FDA), early in FY 1985.
The types of products that are likely to fall under TSCA
jurisdiction include microorganisms used to leach minerals
from ore, purify chemicals, enhance oil recovery, and
degrade cellulose. The section 5 PMN requirement will be
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the principal applicable regulatory authority — EPA has
concluded that the genetic material in new
microorganisms and the new organisms, themselves,
developed through advanced techniques of biotechnology
will be considered as new chemical substances subject to
PMN requirements, if used for TSCA purposes. In
addition, the Agency could use section 8 to gather
information, section 4 to issue rules requiring testing of
microorganisms, section 6 to regulate specific hazardous
microorganisms, and/or section 7 to seek immediate
judicial action in case of imminent hazards.
In FY 1984, the Office of Toxic Substances (OTS)
worked closely with EPA's Office of Research and
Development (ORD) to begin developing a research
program to support PMN review of genetically engineered
organisms. The Agency's goals in biotechnological
research are to develop risk assessment methods for life
forms being sold, distributed, and used in the open
environment or where they may be dispersed by
inadvertent release. In FY 1984, OTS and ORD held
several workshops to identify the highest priority research
needs required to meet these goals.
Since biotechnology products cross many Federal
jurisdictions, EPA is committed to a coordinated
interagency approach to biotechnology. EPA is
participating in a Working Group on Biotechnology,
established by the Cabinet Council on Natural Resources
and the Environment. The purpose of this group is to
coordinate the overall Federal approach to the regulation
of biotechnology, while ensuring that innovation in
biotechnology and the development of socially useful
products are not unduly inhibited.
Because of its international significance, EPA is also
participating in an OECD working group on biotechnology
safety and regulations. The group is looking at scientific
principles governing review of genetically engineered
organisms, as well as relevant member country
regulations.
Followup An important aspect of both the premanufacture review
Program program and the existing chemicals program is the policy
to continue to monitor both new and existing chemicals
that may be of concern if their uses change, or production
volumes significantly increase from those estimated
during their initial review. EPA uses its Significant New
Use authority under section 5 (SNURs) to accomplish this
purpose. SNURs are also used to extend the terms and
conditions of the section 5(e) order to the other
manufacturers and processors of that chemical who
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otherwise could make or process the chemical without
the restrictions placed on the original submitter.
The first final new chemical SNUR was published in FY
1984 on potassium N,N- bis(hydroxyethyl) cocoamine
oxide phosphate and on potassium N,N-bis-
(hydroxymethyl) tallowamine oxide phosphate. EPA
must be notified if a manufacturer or user intends to use
either chemical in certain consumer products at a
concentration greater than five percent. EPA would then
review this notice to see if the new use might present an
unreasonable risk. All new chemical regulatory authorities
would be available if needed.
EPA also proposed nine SNURs covering 18 new
chemicals in FY 1984, to provide guidance to persons
who intend to manufacture, import, or process a chemical
subject to a SNUR.
In addition to the SNURs on new chemicals, EPA also
proposed one SNUR covering two chemicals, using
section 5 authority.
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4
Existing
Program
Status
Information-
gathering
Chemical Testing
TSCA gives EPA the authority to evaluate and control risks
associated with chemicals at any or all stages of
development, from manufacture through disposal. Under
the Existing Chemicals Program, the Agency's goal is to
reduce or eliminate unreasonable risks of injury to health
or the environment from chemicals that are already in
commerce. The objectives of the program are to; (1)
gather needed information; (2) identify and evaluate
potential risks; (3) decide if risk management is required
to reduce risks; and then (4) define and implement the
necessary actions.
EPA has a wide array of sources of information on
chemical risks: section 4 testing; section 5 Significant
New Use Rules; testing from other sources, such as
National Toxicology Program (NTP) risk information under
section 8(e); EPA-generated monitoring; chemicals
subject to citizen petitions under section 21; and
chemicals identified as potentially risky under EPA's New
Chemicals Program. These sources are the starting point
for determining which chemicals present unreasonable
risks. In the area of information-gathering, the Agency has
received 162 testing studies submitted under section 4
(Appendix C), and 16 test studies on 15 chemicals from
the NTP (Appendix D). Since promulgation of the generic
8(a) and 8(d) information-gathering rules in FY 1982, the
Agency has received 4,671 studies and reports on existing
chemicals. Under section 8(e) EPA received 130 notices
of substantial risk, 38 of which were initial submissions
and 92 supplemental or followup submissions. In addition,
the Agency received 227 "For Your Information" (FYI)
submissions. FYI submissions are provided by companies
when they do not believe that the 8(e) requirements are
necessarily triggered, but they want to notify the Agency
of new information.
Section 4 of TSCA was established in response to the
specific concern that the effects of chemical substances
and mixtures on human health and the environment were
not adequately documented or understood. EPA's
chemical testing program is one of the focal points for
developing and accumulating test data under TSCA. Tests
may be required where: the data are insufficient to
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determine or predict effects, testing is needed to develop
such data, and (1) the chemical may present an
unreasonable risk to health or the environment or (2) the
chemical is produced in substantial quantities and there is
significant or substantial human exposure, or substantial
quantities reach the environment. The Administrator takes
these data into account in determining whether, or how,
to regulate or control potentially hazardous substances
under TSCA. These data are also used to provide scientific
information for other EPA offices, as well as for other
regulatory agencies.
Section 4 also established the ITC to review available
data on a variety of chemicals and to designate chemicals
for priority testing consideration. The ITC forwards its
recommendations to EPA in the form of a "Priority List."
This Committee, under the Act, must consider revising its
list every six months. TSCA gives EPA only one year to
perform an independent analysis of available information
on the designated chemicals, and either initiate
rulemaking to require testing of the chemical, or publish
its reasons for not doing so.
EPA issued the first final Test Rule in FY 1984, requiring
that 1,1,1-trichloroethane (TCEA) be tested for
developmental toxicity. TCEA is a high-production volume
chemical, with an estimated 26 million workers and
millions of consumers exposed to it from products such
as aerosols, adhesives and paints.
The Agency has developed the policy of negotiating
testing agreements with industry in order to respond to
the ITC's recommendations within the statutory time
frame. Negotiated testing agreements were a major
portion of EPA's TSCA section 4 program in FY 1984.
However, a U.S. District Court issued a decision in a suit
brought by the NRDC (NRDC v. US EPA, 83 Civ. 8844,
U.S. District Court Southern District of NY) late in the
year, which found that Negotiated Testing Agreements on
chemicals recommended by the ITC were not sanctioned
under TSCA. The Agency will reevaluate its section 4
testing program in FY 1985.
In FY 1984, EPA responded to a total of 43 ITC related
actions covering 30 chemicals. Fourteen were backlogged
designations, 16 were new ITC designations and 13 were
post-initial determinations. These produced: 17 decisions
not to test; 14 Negotiated Testing Agreements; 5 ANPRs;
6 proposed rules, and 1 final rule. In addition, the Agency
signed a Final Rule setting forth procedures for test rule
development and for the granting of exemptions under
TSCA section 4(c). This rule will be published in early FY
1985. Table 2 shows FY 1984 actions taken on
ITC-designated chemicals.
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Table 2
Responses to Interagency Testing Committee (ITC), Designations
Date Chemical Category Action Rule
ITC List
11/4/83 Acetonitrile
11/8/83 Alkyltin compounds
(Includes 7 Chemicals)
11/14/83 Bis(2-ethylhexyl)-
terephthalate
11/14/83 1,3-Dioxolane
11/14/83 Tris(2-ethylhexyl)-
trimellitate
11/15/83 4-(1,1.3,3-Tetra-
methylbutyOphenol
12/7/83 Chlorobenzenes
12/29/83 Aryl phosphates
12/29/83 Formamide
12/30/83 Glycidols
12/30/83 Hexafluoropro-
pylene oxide
12/30/83 Halogenated alkyl
epoxide (others)
1/3/84 Cyclohexanone
1/3/84 Anilines
1/3/84 Ethylene oxide
1/4/84 Propylene oxide
1/4/84 1,2-Butylene
oxide
Final Negotiated Testing Agreement (NTA); health 4
effects testing.
Decision not to test; EPA does not believe there is 7,11
sufficient basis to find that these substances may
present an unreasonable risk to the environment, or that
there is, or may be, substantial environmental release.
Proposed negotiated testing agreement; preliminary 11
decision not to initiate rulemaking. Final NTA June 4,
1984.
Proposed negotiated testing agreement; preliminary 11
decision not to initate rulemaking. Final NTA August 10,
1984.
Proposed negotiated testing program; preliminary 11
decision not to initiate rulemaking. Final NTA June 4,
1984.
Proposed negotiated testing agreement; preliminary 11
decision not to initiate rulemaking. Final NTA July 20,
1984.
Proposed rule-related notice; tentative withdrawal of 1
proposed test requirements, except for proposed
requirement for oncogenicity testing of
1,2,4-trichlorobenzene and proposed health effects tests
for 1,2,4,5-tetrachlorobenzene, based on EPA's analysis
of data and ongoing industry testing. Proposed
negotiated testing agreement.
Advance notice of proposed rulemaking; testing appears 2
necessary to complete rulemaking assessment of the
health and environmental effects.
Final Negotiated Testing Agreement; health effects 10
testing.
Advance notice of proposed rulemaking to solicit public 3
comment on EPA's rationale of selecting chemicals
from this category and to define testing EPA is
considering proposing.
Proposed rule; mutagenicity, oncogenicity, and 2
reproductive effects testing. Teratogenicity and
epidemiology testing not recommended.
Decision not to test for members of the halogenated 2
alkyl epoxide category, other than hexafluoropropylene
oxide.
Proposed negotiated testing agreement for health 4
effects; decision not to test for environmental effects.
Advance notice of proposed rulemaking. EPA is seeking 4
comment on test substances, route of administration,
and sub-categorization. Also seeking information on
exposure, available health data, and data on
environmental effects and chemical fate.
Decision not to test, based on available data, ongoing 1
testing for this chemical, and on regulatory actions
being undertaken by EPA and Occupational Safety and
Health Administration (OSHA).
Proposed rule for teratogenicity testing. 1
Decision not to test; available data and data from 1
ongoing industry testing of this chemical should be
sufficient to determine carcinogenicity; postpone
decision until results of mutagenicity testing are
analyzed; not pursuing ITC recommendation for
epidemiological study.
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Table 2
Date Chemical Category
Action Rule
ITC List
1/4/84 Low production
alkyl epoxides
1/4/84 Quinone
1/4/84 Hydroquinone
1/6/84 1.2-Dichloro
propane
1/13/84 Chlorobenzenes
1/17/84 Isophorone
5/21/84 Methylolurea
5/21/84 Calcium
naphthenate
5/21/84 Cobalt
naphthenate
5/21/84 Lead
naphthenate
5/21/84 2-Phenoxyethanol
6/4/84 Fluoroalkenes
6/19/84 Dichloromethane
6/19/84 Nitrobenzene
7/31/84 Acrylamide
Signed 1,1,1-Trichloro-
9/5/84 ethane
Advance notice of proposed rulemaking; defines 1
rationale for selecting chemicals and regulatory
approaches being considered.
Proposed rule; carcinogenicity, chemical fate, and 5
environmental effects testing. Teratogenicity testing not
proposed.
Proposed rule; to evaluate toxicokinetics, and 5
neurotoxic, reproductive, teratogenic, and mutagenic
effects. Epidemiological studies and chemical and
environmental effects testing also proposed.
Proposed rule; health effects including neurotoxicity, 3
mutagenicity, teratogenicity, and reproductive effects.
Environmental effects include acute and chronic toxicity
tests for aquatic invertebrates and an aquatic plant test.
Proposed rule; chemical fate and environmental effects 1 & 3
tests on mono-, di-, and trichlorinated benzenes;
chemical fate or environmental effects testing of the
tetrachlorobenzenes or pentachlorobenzene not
proposed at this time.
Final Negotiated Testing Agreement; health effects 4
testing.
Advance notice of proposed rule-making; solicit data on 12
exposure, environmental releases, health effects,
chemical fate and environmental effects of
urea-formaldehyde (UF) resins; collect information on
the chemical composition of various UF resins; seek
public comment on criteria for selecting test
substances.
Decision not to test; based on ongoing industry testing. 12
Decision not to test; based on ongoing industry testing.
Decision not to test, based on ongoing industry testing.
Decision not to test; based on ongoing industry testing.
Proposed decision to adopt a negotiated testing
program; decision not to test 3,3,3-trifluoro-1-propene
and trifluoroethane.
Proposed rule withdrawn; additional data received and
ongoing testing sufficient to predict effects on human
health.
Proposed rule withdrawn; additional data received and
ongoing testing expected to provide sufficient data to
determine or reasonably predict effects oi nitrobenzene
on human health. Additional data on environmental
effects led Agency to conclude that the current data do
not support findings necessary to require testing.
Decision not to test; decision not to require health
effects testing.
Final Test Rule; health effects testing. The costs of
conducting the developmental toxicity test are
estimated to range from $62,134 to $186,403 with
annualized costs ranging from $16,000 to $48,300.
Based on these test costs and an analysis of the market
characteristics of TCEA, the economic evaluation
indicates that the potential for a significant adverse
economic impact as a result of this test rule is low.
12
12
12
7
2
3
2
2
16
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Reporting and Section 8 of TSCA authorizes EPA to require reporting and
Recordkeeping recordkeeping on chemicals, substances, and mixtures
This provides the Agency with a mechanism to review
and identify chemicals that might be of concern.
• Section 8(a) authorizes EPA to promulgate rules
requiring manufacturers and processors to maintain
records and report certain risk information to the Agency.
• Under section 8(c), as implemented, companies must
maintain records of alleged "significant adverse
reactions." This information must be provided to EPA
upon request.
• Section 8(d) requires certain manufacturers, processors,
and distributors to submit health and safety studies to
EPA.
EPA has issued rules implementing sections 8(a) and 8(d).
These rules detail the procedures for submitting
information, establish the types of information to be
submitted, and list chemicals on which the information is
to be submitted. The list of chemicals is revised as
necessary when EPA needs the data to assist in fulfilling
other statutory requirements, or to assist in evaluating a
chemical brought to the Agency's attention under various
mechanisms. There are implementing regulations for
section 8(c), and EPA has issued a policy statement to
implement section 8(e).
The following activities were initiated in FY 1984.
• The Agency issued two final rules under section 8(a) in
FY 1984. The first covers chlorinated terphenyls (CTs).
The second covers chlorinated napthalenes (CNs). Any
current or planned manufacture or import of these
chemicals must be reported to EPA. Small businesses are
exempt from these rules. The CT rule was published on
March 26, 1984 (49 FR 11181) and the CN rule was
published on August?24, 1984 (49 FR 33649).
• In addition, as each new ITC list is submitted to EPA,
the Agency automatically amends the section 8(a)
preliminary assessment information and 8(d) rules to
include the chemicals on each list. This ensures that all
available information is submitted to the Agency for use in
decisionmaking for section 4 test rules.
• The final 8(c) rule became effective on November 21,
1983. It requires that manufacturers and processors keep
records of allegations of significant reactions to health or
the environment that were caused by a chemical. These
records must be maintained by the industry; they are
submitted to the Agency upon request. This rule will also
17
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Monitoring
Risk
Evaluation
assist industry in identifying substantial risk cases, and
may trigger reporting to the Agency under TSCA section
8(e).
EPA's monitoring program under TSCA provides important
information on existing chemicals.
A Blood Survey designed to determine the levels and
prevalence of toxic substances in human blood would
complement the Adipose Survey since the chemical
classes being targeted include elemental toxics and
volatile organics, whereas the Adipose Survey has
focused on semi-volatile organics. This network would be
conducted with the cooperation of the three national
blood collection agencies — The American Red Cross, the
American Association of Blood Banks, and the Council of
Community Blood Centers. Pilot testing of the network
and chemical analytical protocols will be conducted in FY
1985, and full network operation is scheduled to begin in
FY 1986.
In FY 1984, results from the Adipose Survey produced
the first "exposure-based" list of chemicals that will
undergo OTS review for potential "unreasonable" risk
levels. This is in direct contrast to previous chemical lists
which have been based solely on toxicological (health
effects) data. In the last several years, results of adipose
tissue analyses have shown that the level of PCBs in
humans is declining. Continued analysis, incorporating
more recent data, indicates that this trend is continuing.
The Adipose Survey also generated data on
hexachlorobenzene (HCB) indicating a high frequency of
human exposure to that chemical. In FY 1984 and FY
1985, EPA will perform its first risk assessment that is
based upon body burden levels of HCB. These
body-burden data, along with toxicological evidence, have
triggered a federally coordinated initiative to gather
information on sources of exposure to HCB.
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 TSCA authorities, and evaluate the
effectiveness of TSCA actions in protecting human health
and the environment.
EPA's information-gathering sources are evaluated in a
five-phase process. These 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.
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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; development
of section 9 referrals to other agencies; and issuance of
chemical advisories to inform those concerned of
measures that can be taken to mitigate potential risks.
Table 3 summarizes Existing Chemicals Program
activities.
Table 3
Summary of Existing Chemical Actions
Information-gathering # in FY 1984
Testing Studies Received under section 4 (See Appendix C) 162
Section 8(d) Health and Safety Studies 3,918
Section 8(e) Submissions Received 130
Initial Submissions 38
- Supplemental/Followup Submissions 92
- "For Your Information" (FYI) Submissions 227
National Toxicology Program - Studies Reviewed (See 16
Appendix D for listing of the 15 chemicals)
Risk Evaluation - Action/Chemical # in FY 1984
Chemical Evaluations
Drop from further evaluation 9
- Continued assessment 52
- Referred for Regulatory Investigation 3
- Section 4(f) Designations 2
- Section 8a/SNUR Referrals 8
Chemical Hazard Information Profiles (See Appendix E for 21
listing)
Section 21 Petitions Received (See Appendix F) 5
Risk Management - Action/Chemical # in FY 1984
Advance Notices of Proposed Rulemaking/ Proposed Rules 3
under section 6(a)
Proposed and Final Rules under section 6(e) 9
Chemical Advisories 4
Chemical Hazard
Information Profiles
In FY 1984, EPA prepared Chemical Hazard Information
Profile (CHIP) documents for 21 chemicals (Appendix E).
CHIPS are sometimes prepared as part of the first phase
of existing chemical reviews. They are brief summaries of
readily available information concerning the health and
environmental effects and exposure potential of a
chemical. Information-gathering for a CHIP is generally
limited to a search of secondary literature sources such as
computerized databases, abstracts, government reports,
scientific review documents, and reference works. While
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TSCA
section 21
Petitions
Risk
Management
Glycol Ethers:
2-Ethoxyethanol,
2-Methoxyethanol
and Their Acetates
—2-EEA and 2-MEA
literature search for a CHIP is not intended to be
exhaustive, in-depth searches on specific topics may be
done on a case-by-case basis. Relevant literature is usually
reported as a narrative summary. Any experimental
conditions and results are briefly described for relevant
studies. These profiles collect and identify data gaps. EPA
uses CHIPs in risk evaluations, not only under TSCA, but
under other authorities as well.
Section 21 of TSCA, 15 U.S.C. 2620(a) and (b), provides
that any person may petition the EPA Administrator to
initiate a proceeding for issuing, amending, or repealing a
rule under various sections of the Act.
The Administrator may hold a public hearing or may
conduct such investigation or proceeding as he deems
appropriate in order to determine whether or not the
petition should be granted. If the Administrator grants the
petition, the Agency must begin promptly to initiate the
action requests by the petitioner. If the Administrator
denies the petition, the reasons for denial must be
published in the Federal Register. Finally, the petitioner
may start a civil action in a district court of the United
States to compel the Administrator to initiate a rulemaking
proceeding requested in the petition.
Five section 21 petitions were received in FY 1984
(Appendix F). A total of 24 petitions have been filed since
February 1978, when the first section 21 petition was
received; 17 petitions have been denied, and 5 have been
granted.
Ensuring that unreasonable risks from existing chemicals
are adequately managed is a high priority for EPA. The
Agency is using both regulatory and non-regulatory means
to eliminate or minimize unreasonable risks. FY 1984
actions are presented below.
2-EEA and 2-MEA are high-production chemicals used
primarily as solvents in paints, coatings and inks, and as
deicers in jet fuel. Animal studies conducted from 1981
through 1984 demonstrated that these particular glycol
ethers cause fetotoxic effects in rats, mice, and rabbits.
The exposure data available to EPA indicate that
significant numbers of workers and consumers may be
exposed to these chemicals at significant levels. EPA is
especially concerned about consumer and trade uses of
these chemicals. Consequently, on January 24, 1984, EPA
published an ANPR in the Federal Register (49 FR 2921).
EPA is investigating the consumer and certain workplace
risks of glycol ethers, and is evaluating alternatives under
sections 6 and 9 of TSCA.
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Methylene _ _ MBOCA is a curing agent used to manufacture certain
Bis(2-chloroaniline) polyurethane plastics. This chemical, a demonstrated
- (MBOCA) animal carcinogen, is not currently manufactured in the
United States. No OSHA standard for it exists. EPA's
primary concern is for persons who work for plastics
formulators using MBOCA (generally small firms). MBOCA
was the subject of an ANPR on May 23, 1983 (48 FR
22954). EPA is exploring both regulatory and
nonregulatory options for managing the risks associated
with MBOCA.
Formaldehyde
1,3-Butadiene
Formaldehyde is an industrial chemical with many uses.
Since 1980, accumulating evidence indicates that
formaldehyde causes cancer in animals and may pose a
cancer risk to humans. In May 1984, EPA announced that
certain formaldehyde exposures would receive high
priority review because of the possibility of a significant
risk of widespread harm to humans from cancer. The
Agency also published an ANPR on May 23, 1984 (49 FR
21870) initiating a regulatory investigation of the two
largest exposed populations: apparel workers and
residents of housing built with formaldehyde-releasing
wood products. The ongoing regulatory investigation is
evaluating the risks and the risk management options.
On January 5, 1984, EPA announced it was initiating an
accelerated 180-day review of 1,3-butadiene under section
4(f) of TSCA, and requested information to help it, and
OSHA, determine whether to initiate appropriate action to
prevent, or reduce risk from this chemical. After reviewing
this information, EPA announced on May 15, 1984 (49 FR
20524), that it was initiating a regulatory investigation to
evaluate the risks as well as the need for risk
management. An inhalation bioassay conducted by the
NTP in 1983 indicates that 1,3-butadiene is strongly
carcinogenic in mice. The bioassay, supported by a
previous industry-sponsored test in rats, also identified
potential reproductive effects associated with this
chemical.
1,3-Butadiene is a high-volume chemical, approximately
three billion pounds of which is consumed per year in the
United States, mostly in the manufacture of rubber and
plastic products. Human exposure data are limited, but
they indicate that some workers may be exposed to
levels that produced tumors in the experimental animals.
Many more workers are exposed to levels that are above
5-10 parts-per-million (ppm). The current OSHA standard
of 1,000 ppm, 8-hour time-weighted average (TWA), is
based on acute toxic effects. In FY 1985, EPA will work
with OSHA to develop a strategy to deal with
1,3-butadiene.
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4,4'-
Methylenedianiline
- (4,4'-MDA)
Polychlorinated
Biphenyls
4,4'-MDA is a high-production chemical used primarily as
an intermediate in the manufacture of other chemicals
and plastics. In June 1979, 4'4-MDA was designated for
testing consideration by the ITC. In June 1982, the NTP
completed a study which indicated serious carcinogenic
potential. Prompted by this study, the evidence of
possible high level workplace exposure, and the absence
of a Federal workplace standard, EPA initiated a
high-priority review under section 4(f). On September 20,
1983, EPA and OSHA issued a joint ANPR. In FY 1984,
EPA assessed the risk management options and
anticipates referring 4,4'-MDA to OSHA in FY 1985.
PCBs continued to be an area of major attention for EPA
and the public in FY 1984. Section 6(e) of TSCA bans the
manufacture, processing, distribution in commerce, and
use of PCBs, with certain exceptions.
In FY 1984, three final rules were promulgated on PCBs
in the July 10, 1984 Federal Register (49 FR
28154-28209). The first rule set numerical cutoffs for the
inadvertent generation of PCBs. A second rule took action
on 109 individual and class petitions for exemptions from
the PCB bans. The third rule established PCB use
authorizations for small quantities in research and
development, and other limited uses. Two other
regulatory action PCBs were initiated in FY 1984.
The first rule, referred to as the Inadvertently Generated
PCBs Rule, limits the concentration of PCBs inadvertently
generated in manufacturing processes, and concentrations
in certain processes which recycle PCBs. The
Inadvertently Generated PCBs Rule also sets limits on the
discharge of wastes to water, ambient air, and to solid
waste streams from these processes. This rule also
includes an authorization under certain circumstances for
the continued use of low levels of PCBs in heat transfer
and hydraulic systems.
The second final rule in FY 1984, referred to as the
Exemptions Rule, granted 58 individual and class petitions
for exemption from the prohibitions against the
manufacture, processing, and distribution in commerce of
PCBs, after determining that these activities do not pose
an unreasonble risk of injury to health or the environment,
, and that the petitioners had made good faith efforts to
find or develop a substitute for the PCBs. Fifty-one
petitions were denied in this rule.
The third final rule in FY 1984 authorized the use of
PCBs in small quantities for research and development in
certain applications in microscopy and as optical fluids.
In addition to the three final rules, EPA initiated two
other regulatory actions regarding PCBs in FY 1984. In the
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March 23, 1984, Federal Register, EPA published an
ANPR (49 FR 11070) soliciting comments on the
fire-related risks posed by PCB transformers. In this
notice, EPA announced its intention to develop a
proposed rule that would seek to reduce the risks caused
by fires in PCB electrical transformers. On September 28,
1984, the Administrator signed a proposed rule (49 FR
39966).
Finally, on July 23, 1984, EPA published a proposed rule
(49 FR 29625) to modify the March 31, 1979 PCB rule by
redefining the term "totally enclosed manner" for
PCB-related activities, and changing other portions of the
rule to clarify the Agency's position on exactly what
constitutes significant exposure to PCBs.
Asbestos EPA is committed to eliminating unreasonable risks posed
by asbestos exposures. The Agency has had an abiding
concern about asbestos because of the well-documented
hazards associated with inhalation of asbestos fibers.
Since 1979, EPA has provided technical assistance to
schools and other building owners. FY 1984 saw
expansion of this technical assistance program.
Increasingly throughout the year and peaking during the
summer of FY 1984, public interest focused attention on
asbestos. During FY 1984, for example, EPA received
over 75,000 telephone calls requesting technical
assistance and requests for approximately 80,000
asbestos documents.
Due to the crucial need to educate the public about
asbestos in buildings, EPA greatly expanded its outreach
efforts in FY 1984. The Agency announced the
establishment of three pilot information centers in FY
1985 at the regional level to provide information
concerning the identification and abatement of asbestos
hazards, and to educate and train people in proper
asbestos identification and abatement techniques. These
centers will sponsor technical symposia and conferences
to train people involved in various aspects of asbestos
identification and abatement. Target audiences for the
centers will include: maintenance personnel, building
managers and owners, school officials, parents, architects,
abatement contractors and workers. These pilot
information centers will also serve as information
clearinghouses to distribute guidance documents,
manuals, and audio-visual materials.
Another important outreach effort was initiated in FY
1984. EPA plans to help establish a State contractor
certification program for abatement contractors in FY
1985. This program will include model State legislation
designed to establish effective contractor certification
23
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programs at a State level, and pilot contractor certification
programs set up in several States. During FY 1984 the
Agency worked with three States to establish these pilot
programs. This will lead to more effective abatement of
asbestos hazards and reduce risks to both abatement
workers and people using buildings with asbestos
hazards. If these programs are successful, EPA may
expand them to additional States in FY 1985.
Still another important new initiative in FY 1984 was the
effort to implement the Asbestos School Hazard
Abatement Act of FY 1984, which Congress passed in
August. This Act established a loan and grant program to
support abatement programs in schools with the most
serious asbestos problems and demonstrated financial
need. Interim abatement loan and grant application forms
have been developed and will be distributed early in the
next fiscal year. EPA expects that the first-year funds will
be allocated by June, 1985.
In FY 1984, EPA conducted a national survey to
determine the extent of asbestos-containing friable
materials in buildings. This survey was part of OTS' effort
to deal with the broader problem of public exposure to
asbestos from friable asbestos building materials. The
primary objective of the survey was to generate valid
national estimates of the number of buildings that have
asbestos-containing materials for use in OTS' asbestos
program. Overall, approximately 80 percent of all buildings
represented by the survey do not contain friable asbestos
materials. Thus, of the 3.5 million buildings represented
by the survey, it is estimated that about 2.8 million
buildings do not contain friable asbestos.
EPA also conducted a survey on compliance with its
Asbestos-in-Schools rule as well as on the extent of
abatement in schools that found asbestos. Although
compliance with the major provisions of the rule was low,
most schools made an effort to inspect, and most schools
that found asbestos have either initiated or completed
abatement.
Chemical FY 1984 marked the first use of Chemical Advisories by
Advisories EPA. An advisory is written to give individuals or
organizations information on the hazards of specific
chemicals, and practical steps that can be used to
minimize or eliminate these hazards. Advisories are
distributed directly to those who can taken action to
reduce risk. They are not rules. They are written by EPA
after consultation with interested parties such as
companies, labor organizations, public interest groups, and
other agencies. Chemical Advisories are designed to be
24
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Used Motor Oil
Metalworking
Fluids
Leaking
Underground
Storage Tanks
used where an increased awareness of potential risk is
likely to lead to meaningful precautions, and are
addressed and distributed to individuals or organizations
for whom the information is most useful. They are
intended to encourage voluntary risk-reduction actions by
individuals or organizations, or as a complement to a
regulatory action.
During FY 1984, EPA issued four Chemical Advisories:
one on used motor oil (published in English and Spanish);
one each to formulators and metalworkers on
metalworking fluids; and one on leaking underground
storage tanks.
Service station workers, engine mechanics and any other
workers who handle motor oil were advised to minimize
skin contact with used oil, and to remove any used oil
from their skin promptly. The advisory was issued after a
laboratory study showed that mice developed skin cancer
after their skin was exposed to used motor oil twice
weekly for most of their life span without being washed
off.
Adding inorganic nitrite corrosion inhibitors to
metalworking fluids containing secondary and tertiary
amines results in the formation of nitrosamines,
particulary n-nitrosodiethanolamine (NDELA). Recent
studies indicate that NDELA is an animal carcinogen at
relatively low doses. In FY 1984, EPA initiated a regulatory
investigation under section 6 of TSCA to explore the need
for, and feasibility of, risk management regulations.
In September 1984, as an interim measure while
rulemaking was being considered under section 6, the
Agency issued two chemical advisories concerning the
addition of inorganic nitrites to water-based metalworking
fluids containing secondary and tertiary amines. The first
advisory, which is directed to formulators, recommends
that nitrites not be added during formulation of
metalworking fluids that contain amines; it also
recommends that fluids containing both nitrites and
amines be labelled to warn users of potential nitrosamine
contamination. The second advisory, addressed to end
users, also advises against adding nitrites to
amine-containing fluids, and recommends precautions to
reduce exposure to metalworking fluids that may be
contaminated with nitrosamines.
Gasoline, other petroleum products, hazardous wastes,
and other chemicals are stored in above-ground and
underground tanks of various sizes, construction
materials, and designs. Evidence suggests that leaking
underground storage tanks are a significant cause of
25
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TSCA
section 9 and
Workplace
Referrals
groundwater contamination in several parts of the country
and may be leading to serious contamination of water
supplies.
In FY 1984, EPA began to examine this problem in
depth to gather as much data as possible to better
characterize its scope and magnitude.
In addition, EPA is taking two major actions in this area.
First, OTS has issued a Chemical Advisory alerting owners
and operators of underground motor fuel storage tanks to
the potential problems should a leak occur. As the
advisory explained, leaks from tanks and pipes not only
represent sources of drinking water contamination, but
can also damage underground structures (such as sewer
lines and telephone cables), present fire or explosion
hazards, and damage crops, livestock, and wildlife. Even
in small amounts, long-term exposure to motor fuels may
cause health problems. A background booklet, prepared to
supplement information available in the Chemical
Advisory, also provides information on how to test for,
report, and repair underground leaks.
Second, OTS designed a statistically-based national field
study of motor fuel tanks to help assess the magnitude of
the leaking tank problem and to develop sound
information upon which to base Federal regulations. A
pilot survey conducted in FY 1984 was designed to test
the entire field survey procedure. In addition, OTS is
assisting other EPA offices to implement those portions
of the recently passed Resources Conservation and
Recovery Act Amendment which apply to underground
storage tanks.
One important effort during FY 1984 was the
development of an interim policy for referring workplace
exposure problems to the Department of Labor (DOL).
Under TSCA, EPA is responsible for protecting public
health from unreasonable risks arising from the
manufacture or processing of chemicals. Similarly, DOL is
responsible, under the Occupational Safety and Health
and the Mine Safety and Health Acts, for protecting the
health of workers. When toxic chemical exposures occur
primarily within the workplace, jurisdictional issues must be
resolved to ensure that these exposures are adequately
addressed without unnecessary duplication of effort.
Section 9(a) of TSCA authorizes EPA to refer chemical
problems to other agencies. EPA and DOL initiated efforts
during FY 1984 to develop a comprehensive
Memorandum of Understanding (MOU) that would govern
relationships between the two agencies concerning
workplace risks.
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5
Quality of Data
EPA has long been concerned about the quality of data
that are submitted under TSCA. The Agency is dealing
with this issue by establishing guidelines for acceptability
of tests and by vigorously auditing laboratories to ensure
that good laboratory practices are used.
Test EPA develops generic test methods guidelines that are
Guidelines citec' as standards in promulgated test rules, or are used
as the basis for deriving acceptable chemical-specific test
standards for test rules (47 FR 13012). EPA has
anticipated testing needs by developing guidelines for a
wide variety of test methods in the health, environmental,
and chemical fate areas. These guidelines are available
through the National Technical Information Service (NTIS).
EPA ensures that test methods are consistent and of
acceptable scientific quality by ensuring that each
guideline is peer-reviewed by scientists in other EPA
program offices, and by expert scientists in the academic
community. State and Federal agencies, public interest
groups, and industry.
EPA reviews responses from solicited public comments
and other information-gathering procedures to ensure that
selected guidelines and promulgated standards reflect the
most current and valid testing practices. Where the
review warrants, EPA updates guidelines and/or
standards. During FY 1984, EPA updated six guidelines.
Among the updates were revisions of three Acute Toxicity
Testing guidelines. These revised guidelines reflect the
Agency's policy concerning the need to assess the
potential acute effects of chemicals, while reducing to a
scientifically acceptable minimum the number of animals
used in tests.
The Agency also is continuing its program of
coordination and harmonization of test guidelines with the
OECD. In FY 1984, EPA distributed for review four new
OECD generic test method guidelines in the health and
chemical fate areas.
27
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Good In addition to establishing test guidelines, EPA scrutinizes
Laboratory tne quality of data upon which it must make crucial
Practices decisions in other ways.
On November 29, 1983, the Agency promulgated a
Good Laboratory Practice Standards Rule (48 FR 53922)
which became effective on December 29, 1983. This rule
established GLPs for conducting health effects and
environmental effects testing under TSCA. It specifies
requirements for areas such as facility operations,
maintenance of equipment, and record keeping, and is
intended to ensure the quality and integrity of data
submitted to the Agency under TSCA.
EPA's Compliance Monitoring Staff has the lead
responsibility within the Office of Pesticides and Toxic
Substances for inspecting laboratories for compliance, and
for auditing studies to determine if test reports reflect
study results accurately and completely. This program is
coordinated with, and supported by the EPA, FDA, and
the NTP. Under this compliance monitoring program, the
EPA Regional Offices or the FDA conduct GLP inspections
of laboratories. Audits of studies are also conducted by
EPA, and report reviews are conducted by EPA scientific
staff, with support from the NTP. In FY 1984, EPA
conducted nearly 50 laboratory inspections.
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6
Toxics Integration
During FY 1984, the Toxics Integration Program continued
to develop policies and procedures to coordinate and
integrate Agency and Federal activities related to toxic
substances. These activities included: 1) developing and
managing various databases and information resources to
improve internal and external interagency coordination; 2)
developing Agency-wide chemical strategies; and 3)
coordinating OTS activities with those of other EPA
offices and Federal agencies. All of these measures were
designed to avoid duplication and coordinate a consistent
approach to evaluating and controlling toxic chemicals.
Databases Tne fourth edition of the EPA Chemical Activities Status
Report (EPACASR) was published in FY 1984. It provides
brief descriptions of the Agency's chemical-specific
activities as they affect more than 3,800 chemicals and
chemical categories. The computer database, which
includes descriptions of a number of activities conducted
by agencies other than EPA, as well as EPA's efforts,
addresses some 8,400 chemicals and chemical
categories. Printed copies of the EPACASR, available
through the NTIS, provide ,an important reference source
for anyone following chemical regulatory and
pre-regulatory activities.
Computer printouts on chemicals of concern have been
provided on request to governmental bodies who need to
identify available information resources and contact points.
Efforts to provide direct computer access to these
organizations are in progress, and a tape version of the
EPA portion of the database is currently available
commercially through the NTIS.
EPA also developed the Guide to EPA Activities on
Toxic and Hazardous Chemicals. This document provides
EPA managers with overview information on the status of
EPA's planned, ongoing, and completed activities on
chemicals, especially those chemicals which are
addressed by more than one EPA program.
The guide, along with EPACASR, is a tool used to: 1)
direct EPA managers to other programs that may provide
information on a chemical substance of interest to the
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program; and 2) highlight chemical substances of interest
to more than one program by pointing out a potential
need for coordinating the general or specific activities of
the entire Agency, or of selected programs.
To ensure that all EPA programs are coordinated, a
crosswalk document was developed during FY 1984 to
provide Chemical Abstract Service (CAS) registry numbers
for 1,545 of the 1,632 active pesticide ingredients
currently registered. Before this document appeared, EPA
identified active ingredients solely by internal file
numbers. Assigning CAS registry numbers has facilitated
communication between data holders in EPA, and
between EPA and other agencies.
In addition to chemical-specific databases, EPA also
developed other databases concerning industry activities.
During FY 1984, the Industry File Information System
(IFIS) became operational. An automated guide to EPA's
industry regulations as viewed from a chemical's
perspective, IFIS enables the user to determine, for a
particular industry, which chemicals are used or produced,
and whether and how these chemicals are regulated,
including the statutory authority. A document was also
prepared that identifies key EPA staff who are working in
over 77 industry categories. Lead program office contacts
have been provided for each industry category. This
document, like EPACASR, is becoming a standard EPA
reference tool.
The Extramural Activity Report (EAR) was issued during
FY 1984 to ensure contract coordination within the
Agency. It includes descriptions of toxics-related projects
being developed under contracts as well as cooperative
agreements or assistance programs funded by EPA. Its
purpose is to assist in planning and developing extramural
efforts by providing a source of information about
extramural projects currently being funded throughout the
Agency. Coordinating these efforts has improved their
quality and consistency, and duplications have thus been
avoided.
Chemical A major effort in FY 1984 was the continued development
Strategies °f Agency-wide chemical strategies to deal with issues
concerning arsenic and lead, while another new effort
addressed hexachlorobenzene (HCB).
During FY 1984, the Agency directed efforts in its
arsenic and lead strategies toward regulatory and
evaluation activities in both its air and pesticide programs,
and in the Superfund Program.
HCB has been detected in almost all human fat
samples taken in monitoring studies. Moreover, HCB
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Coordination
Activities
Other
Activities
shares many toxic properties of other highly chlorinated
aromatic hydrocarbons, for example, dioxins and
chlorinated dibenzofurans. HCB has been shown to be
carcinogenic and teratogenic in animals, and it is
suspected of being a human carcinogen. Human beings
appear to be exposed to it from a variety of sources.
The HCB effort is preregulatory and will be completed
in 1986. EPA and other Federal agencies will use this
effort to: 1) identify sources and routes of exposure; 2)
define exposure and body-burden levels that may cause
adverse health and environmental effects; and 3) compare
these levels with measured or estimated levels of
exposure so that populations and environmental
compartments at risk can be identified. A strategy will
then be developed to direct EPA's efforts on the most
critical problems concerning HCB.
These efforts will lead to developing multi-media health
and exposure assessment documents to be used by all
EPA programs and other Federal agencies. These
documents are tools for managers to use to save
resources and avoid duplication.
By participating in various key Agency work groups on
specific chemicals of interest to OTS and other programs,
chemical data available within OTS are identified to ensure
that the most upto-date information is used to develop
Agency regulations. Chemical data collected under TSCA
are currently being used and analyzed by the Offices of
Research and Development (ORD) and Solid Waste and
Emergency Response to support their research and
regulatory efforts.
During FY 1984, several EPA Regional offices were
briefed on the various information resources available
within OTS that they may use to develop assessment
documents and conduct site-specific analyses. As more
TSCA data become available, these data are being made
available to other EPA program offices.
Other FY 1984 projects which helped to improve
coordination and avoid duplication included an exposure
assessment initiative, and the continued development of
intermedia documents concerning various chemicals.
The exposure assessment activity brought together
those program offices that conduct exposure
assessments, and convened a body that revised the
Agency's exposure assessment guidelines. As a result of
the development of this guideline, EPA intends to develop
comprehensive exposure documents that meet its
multiple requirements.
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Under its program for developing multi-media
assessment documents, EPA completed three new
Intermedia Priority Pollutant documents (IPPs) in FY 1984
on chlordane, ethylene dibromide, and nickel. In addition,
four of the original IPPs covering benzene, chlorinated
organic solvents, PCBs and 2,3,7,8-TCDD were updated.
The program to develop IPPs began in FY 1983 when
these documents were completed on 23 chemicals. IPPs
are designed to provide an overview of current regulatory
and technical information on a group of toxic chemicals of
intermedia concern. Topics covered include:
physical/chemical properties; health and environmental
effects; production, use, release, and exposure;
regulatory status; recommended criteria and standards;
spill cleanup/disposal and a description of analytical
methodologies. EPA Headquarters and the Agency's
Regional offices use IPPs in their daily activities.
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7
Compliance and
Enforcement
Program
Actions
Compliance
Actions
EPA has developed specific strategies to enforce
regulations under TSCA. These strategies identify and
rank possible violations, identify the available tools for
compliance monitoring, specify how these tools are to be
used, and provide a formula to determine the application
of inspection resources. Where inspections uncover
violations of TSCA requirements, EPA levies civil penalties
and, as appropriate, criminal penalties, as authorized by
TSCA section 16.
During FY 1984, EPA developed and issued a general
TSCA Compliance Monitoring/Enforcement Strategy and
specific compliance monitoring strategies for: TSCA
section 13 Import Requirements; the TSCA section 8(c)
rule; and the TSCA section 8(d) rule. EPA developed and
issued enforcement response policies for TSCA sections
8, 12, and 13 reporting and recordkeeping regulations, and
a revised enforcement policy for the TSCA section 6
Asbestos-in-Schools Rule.
During FY 1984. EPA stepped up inspection activities
under TSCA; the number of inspections more than
doubled from FY 1983. The EPA, along with four State
agencies cooperating under the terms of enforcement
grants-in-aid, conducted 1,440 PCB compliance monitoring
inspections. In addition, the Agency, operating under a
cooperative agreement with the American Association of
Retired Persons and one State agency, conducted 1,945
asbestos-in-schools inspections. The Agency conducted 7
inspections to monitor compliance with the interagency
ban on nonessential aerosol uses of chlorofluorocarbons,
and conducted 14 inspections to determine compliance
with the dioxin rule under section 6. The Agency also
conducted 212 compliance inspections at facilities subject
to section 5 requirements.
During FY 1984, the Agency also monitored compliance
with section 4 and 5 requirements, TSCA section 8
reporting and recordkeeping requirements, and the
section 13 import rule. The Agency inspected 47
laboratories conducting testing under TSCA to determine
if the laboratories were in compliance with GLP
requirements. During these inspections, EPA performed
162 data audits of health and environmental tests to
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Civil
Enforcement
Actions
determine if testing had been conducted according to test
protocols, and if reports accurately reflected study
findings. The Agency also conducted over 500 section 5
compliance inspections, and inspections to determine
compliance with section 8(a) level A reporting
requirements, and with section 8(c) rules requiring
manufacturers, processors, and distributors to keep
records of significant adverse reactions to chemicals.
Inspections to determine compliance with section 8 were
conducted at 162 firms. On January 1, 1984, a policy
statement interpreting the U.S. Customs Service's
Chemical Substances Import Rule became effective (see
Section 10, International Activities). A total of 494
inspections were conducted to determine compliance
with this rule.
In FY 1984, most of the enforcement actions under
section 16 involved alleged violations of the PCB .rules. As
a result of PCB inspections, the Agency filed a total of
283 civil complaints during the fiscal year. The Agency
also issued 82 civil complaints for alleged violations of the
section 6 asbestos-in-schools requirements. These
complaints represent the first asbestos enforcement
actions taken by the EPA under TSCA. In addition, EPA
issued 11 civil complaints for alleged violations of section
5. Figures for each EPA Regional Office appear in Table 4.
Table 4
Administrative Civil Actions Taken under section 16 of
TSCA, Complaints Issued, Cases Completed, and
Amounts Assessed (by Regions)*
Region
1
2
3
4
5
6
7
8
9
10
HQ.
Total No. No. Total No. No. Cases
Complaints Complaints Cases Completed**
Issued Issued Completed in FY'84
FY'79-84 FY'84 PT7M4
29
142
81
67
286
114
83
75
53
37
17
12
40
45
40
100
32
30
30
25
16
6
18
88
46
35
184
84
60
53
31
20
10
6
17
18
19
59
22
22
14
10
9
6
Total
No. of
Cases
Pending
11
54
35
32
102
30
23
22
22
17
7
Total Civil
Penalties
Collected
(in $) FY'84
86,468
227,000
116,325
86,272
345,315
71,050
99,480
124,815
158,000
51,750
362,750
Total Civil
Penalties
Collected
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8
Litigation
Environmental Defense Fund, Inc., v. Environmental
Protection Agency (No. 79-1580, D.C. Cir.)
In 1979, the Environmental Defense Fund (EOF) petitioned
for review of EPA's regulations under TSCA section 6(e)(2)
and (3) governing the manufacture, processing,
distribution, and use of 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.
As a result of the Court's orders in this case, EPA has
issued three additional PCB rules. During August 1982,
EPA issued a regulation affecting the use of PCBs in
electrical equipment; in October 1982, the Agency issued
a rule providing an exclusion from the statutory ban for
PCBs, produced in closed manufacturing processes or
controlled waste processes, that are disposed of in an
acceptable manner; finally, during July 1984, EPA issued a
regulation affecting other PCBs generated inadvertently in
chemical manufacturing processes. These rules, in turn,
have generated other litigation and other regulation. The
developments for FY 1984 in this case and related
rulemaking follow.
Last year's annual report discussed the litigation and
progress in settlement negotiations involving the August
18, 1982, electrical equipment rule. Early in FY 1984, EPA
entered into two separate agreements whereby parties
who had filed petitions for review agreed to dismiss their
suits should the Agency conduct two additional PCB
rulemaking proceedings within agreed-upon time limits. In
one rulemaking, EPA amended its PCB rule to reflect
current Agency policies concerning PCB exposure
assessment; EPA decided to delete the definition of
"significant exposure," which stated that any exposure to
PCBs is significant, in favor of a statement that recognizes
that significant exposure depends upon the quantity of the
PCBs involved, the likelihood of exposure to humans, and
the effect of exposure. In the second rulemaking, EPA will
deal with risks from fires involving transformers containing
PCBs. The Agency expects to complete the fires rule in
FY1985.
A petition for review of the October 12, 1982, PCB rule
was filed by the Chemical Manufacturers Association in
December 1982. By agreement of the parties, approved
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by the Court, this petition was stayed pending further
PCB rulemaking. No further action has been taken on this
petition to date, nor is any expected since the July 1984
rule has apparently resolved the Association's concerns.
In late September 1984, petitions for review were filed
on the July 1984 rule by the American Die Casting
Institute and Outboard Marine Corporation in the Seventh
Circuit, and by the American Paper Institute and Fort
Howard Paper Company in the D.C. Circuit. Settlement
discussions are proceeding in these cases.
After the issuance of the July 1984 rule, the
proceedings in the following previously reported cases
have been terminated: Olin Corporation v. EPA (No.
79-1437, 4th Cir.); General Electric Company v. EPA (No.
79-1816, D.C. Cir.); Aluminum Company of America v.
EPA (No. 79-1811, D.C. Cir.); The Dow Chemical
Company v. Ruckelshaus (No. 82-3536, 3d. Cir.) and The
Dow Chemical Company v. Ruckelshaus (No. 80-1498, v
3rd. Cir.) [The latter case is an appeal from The Dow
Chemical Company v. Costle (Civ. Action No. 79-581, D.
Del), described in previous annual reports.] The settlement
agreement in the Dow consolidated cases was described
in last year's report. The terms of the agreement were
carried out during FY 1984.
NRDC v. EPA (No. 82-2039, D.D.C.)
On July 18, 1983, public interest groups challenged EPA's
decision not to take steps to place formaldehyde on a
priority track for evaluation under section 4(f) of TSCA.
Under section 4(f), if EPA receives information which
indicates that there may be a reasonable basis to
conclude that a chemical presents a significant risk of
serious or widespread harm to human beings from
cancer, gene mutations, or birth defects, within 180 days
EPA shall initiate appropriate action under sections 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 claimed that EPA's decision, in early 1982, not
to evaluate formaldehyde under section 4(f) was unlawful
for two reasons. First, plaintiffs argued that EPA applied
too strict a standard for triggering the 4(f) "significant risk
of serious or widespread harm" finding. Second, plaintiffs
claimed that the decision was .tainted by unlawful Agency
conduct because EPA had held private meetings with
industry groups in the summer of 1982 and had
improperly evaluated animal test data.
In response to this litigation, EPA revoked its 1982
decision on formaldehyde and announced it would issue a
new decision in May 1984. The court stayed the
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proceeding until the new decision was published. In May
1984, EPA declared that two general categories of
formaldehyde exposure triggered the section 4(f)
"significant risk of serious or widespread harm" finding:
(1) exposure associated with manufacture of apparel from
fabrics treated with formaldehyde-based resins and (2)
exposure from residence in conventional and
manufactured (mobile) homes containing construction
materials in which certain formaldehyde resins are used.
EPA simultaneously issued an AN PR which the Agency
considered a fulfillment of its related duty under section
4(f) to "initiate appropriate action" within 180 days. In the
AN PR, the Agency announced an investigation to consider
the appropriate ways in which it could most effectively
regulate formaldehyde. The plaintiffs disagreed that this
action constituted the appropriate action under section 4(f)
and filed an additional round of motions on the issue.
After hearing arguments by both parties, the court
decided that the May 1984 decision entirely supplanted
the 1982 decision and the further controversy on whether
the ANPR constituted "appropriate action" raised issues
on a different administrative record that had not been
presented to the court. Accordingly, the court dismissed
the case as moot without prejudice to the plaintiffs' right
to bring a complaint concerning EPA's May 1984 action, if
and when appropriate.
NRDC v. U.S. Environmental Protection Agency (No.
83 Civ. 8844, S.D.N.Y.)
In this case, plaintiffs challenged four aspects of EPA's
statutorily-mandated chemical testing program under
TSCA section 4 (see discussion in Chemical Testing).
Specifically, plaintiffs challenged: (1) using negotiated
testing agreements in lieu of initiating rulemaking under
TSCA section 4(a); (2) issuing an ANPR rather than a
notice of proposed rulemaking; (3) the use of a two-phase
rulemaking process in which EPA first decides whether to
test a chemical and, in a subsequent phase, decides what
methodology should be used; and (4) the failure to issue
final rules for a number of proposed test rules which were
issued in 1980 and 1981.
On August 23, 1984, the court issued an Order and
Opinion stating that the Agency did have discretion both
to initiate rulemaking by issuing an ANPR and to use a
two-phase rulemaking process as long as its use does not
delay rulemaking unreasonably. The Court, however,
found that the use of negotiated testing agreements for
ITC-designated chemicals was not supported by TSCA or
its legislative history. The Court ordered EPA to meet with
plaintiffs to construct a schedule to convert the
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challenged negotiated agreements into statutory test
rules, and also take final action on the three outstanding
proposals. On September 24, 1984, the Agency and
plaintiffs submitted a jointly proposed schedule for action
on the eight chemicals subject to the Court's Opinion and
Order. The Court adopted this schedule as part of its Final
Judgment and Order of October 30, 1984.
Service Employees International Union (SE/U) v.
Ruckelshaus, (No. 84-2790, D.D.C.)
SEIU is seeking standards for determining when an
asbestos hazard requiring correction exists in schools,
requirements for abatement activities where such hazards
exist, and standards for performing abatement activities,
including standards to protect persons performing
abatement. SEIU argues that EPA has a mandatory duty
to issue such rules based on promises made by the
Agency in response to citizens' petitions. Alternatively,
SEIU has argued that EPA has failed to complete
rulemaking actions on asbestos hazards in a reasonable
time. The SEIU brought this action to require EPA to
propose these rules and a rulemaking timetable within 30
days. SEIU has also asked the Court for preliminary relief
of the same nature.
Only the preliminary injunction has been argued to date.
EPA argued that preliminary relief is an extraordinary
remedy and is particularly inappropriate in this case, since
EPA has no mandatory duty to issues rules, has not
unreasonably delayed responding to SEIU's request to
conduct rulemaking, and has an ongoing asbestos
program that is working to alleviate the asbestos problem.
The parties are awaiting the Court's decision.
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9
State Programs
During FY 1984, under the authority of section 28(c) of
TSCA, EPA continued to support previously awarded State
grants to assist in programs that prevent or eliminate
problems created by toxic substances. Since 1978, 11
toxic substances programs in 8 States have been
implemented with EPA assistance.
The availability of $3 million for this Federal assistance
program was announced in August 1978. These funds
were distributed in a two-cycle award process. Half were
distributed in 1979, and the other half in 1980. Availability
of an additional $1.25 million was announced in February
1980, and a third and final cycle was initiated. Appendix G
shows the status of these awards.
By the end of FY 1984, ten State cooperative
agreement projects were completed, of which eight were
completed in FY 1984. These involved the Wisconsin
study of health problems related to formaldehyde in
mobile home construction; the North Carolina toxic
management project; the Puerto Rico* toxic substances
management strategy and expansion of public
participation/awareness programs; the Michigan Critical
Materials Program and Interdepartmental Risk
Assessment (two cooperative agreements); the Maryland
Toxic Substances Registry program to ensure safe and
effective containment of toxic substances in storage tanks
(two cooperative agreements); and the New York project
to integrate the services of State and local governmental
agencies to manage toxic contamination problems.
Finally, under two cooperative agreements, New Jersey
completed the following projects: the Toxic Substances
Investigation and Integration Unit; the Mobile Monitoring
Unit; a study of in-place mercury; an Emissions
Monitoring Program; a study of the sub-lethal effects of
toxic chemicals on aquatic organisms; field applications of
in vitro mutagenesis tests; and the Technical Information
Resources Center.
The cooperative agreement with the Illinois Department
of Health to develop an integrated voluntary system to
detect morbidity and mortality rates resulting from
* As defined by TSCA, "State" includes any U.S. territory or
possession.
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exposure to toxic substances, ongoing since 1981, was
extended at no cost from June 1984 through June 1985.
In addition, EPA has had an ongoing pilot TSCA
cooperative agreement program to monitor compliance
with the PCB regulations in the States of Connecticut,
Maryland, Michigan, and Ohio since 1981. These four
States conducted 350 compliance inspections during FY
1984.
In May 1984, EPA awarded the State of California a
cooperative agreement to conduct compliance monitoring
activities concerning the presence of asbestos in schools.
Twenty-seven local education agencies were inspected
during FY 1984.
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10
International Activities
Since the passage of TSCA, EPA has been involved in a
variety of international activities centering on approaches
to evaluating and controlling toxic substances. EPA
considers these programs of critical importance for many
reasons. Toxic substances issues often transcend national
boundaries. In addition, varying national regulation of
chemicals can affect international trade and influence the
economic stability of the chemical industry. These
international activities include the exchange of information
and expertise, which offers significant benefits to all
participating nations. EPA promotes the success of these
international programs by sharing its technical expertise
and its broad experience in chemical review and control.
The most visible of EPA's international efforts, and
perhaps its most successful, is its participation in the
Chemicals Group and Management Committee of the
OECD. The OECD, a 24-member international organization
composed of the world's major industrialized nations, was
founded to promote development of, and prevent barriers
to, international trade. Due to a proliferation of national
chemical laws during the 1970s, the OECD membership
recognized the potential for chemical trade barriers and
established a program in 1977 to develop harmonized
approaches to the review, evaluation and control of toxic
substances.
During FY 1984, EPA participated in several projects
designed to advance the harmonization aims of the
Chemicals Program. EPA played an important role in the
success of two major activities. An initiative on existing
chemicals, consisting of four sub-projects to identify
information needs of member countries, was completed.
As a result of these existing chemical activities, member
states reached agreement on a common format for
conducting chemical reviews and on criteria for
determining whether the health and environmental data
on chemicals are adequate. In addition, EPA led an effort
to develop a referral mechanism in order to improve
access to unpublished information on chemicals. This
effort has been called the Switchboard, and a small
number of countries will participate in an experimental
implementation of it in early 1985.
After two years of intensive effort, member states
41
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reached agreement on guiding principles to govern the
exchange of information on exports of banned or severely
restricted chemicals. These principles, for which TSCA
section 12(b) served as a model, were formally adopted
by the OECD Council in a Recommendation in April 1984.
In a major ongoing effort, EPA participated in the OECD
Test Guidelines Program. Activities are concentrated in
the Updating Panel, whose mandate is to ensure that
OECD Test Guidelines are kept current with the
state-of-the-art. EPA serves as an advisor to the panel.
Developing OECD Test Guidelines will improve the quality
of data developed worldwide, and reduce the need for
duplicative testing.
During FY 1984, considerable time and effort were
devoted to developing and promoting agreement on a
three-year workplan (1985-1987) for the Chemicals
Program. As a result of extensive member state
deliberations in the spring and fall, program activities were
reorganized along more efficient lines, and the group
agreed to focus its efforts on assessing hazards and
developing model agreements for the exchange of
confidential information and compliance with good
laboratory practices. Renewed emphasis was placed on
upgrading work in the area of economic aspects of
chemicals control.
EPA also participates in several programs of the United
Nations, such as the United Nations Environment Program
(UNEP) International Register of Potentially Toxic
Chemicals (IRPTC) and the World Health Organization
(WHO) International Program on Chemical Safety (IPCS).
The basic objective of the IRPTC is promoting more
efficient use of national and international resources in the
evaluation of chemicals. EPA supports IRPTC by providing
scientific and regulatory information on chemicals, and by
responding to chemical inquiries relayed through IRPTC
headquarters in Geneva.
The IPCS was established in response to a recognized
need for a collaborative international approach to evaluate
the effects of chemicals on health and the environment.
Member state experts work within the IPCS to develop
assessment documents on chemicals, set exposure
guidelines, coordinate testing when appropriate, and
promote technical cooperation and training. EPA serves on
the Program Advisory Committee to IPCS, which met in
the fall of 1984 in Nairobi. During FY 1984, EPA
participated in establishing the IPCS priority list to develop
assessment documents and assist in preparing
assessment documents on methylene chloride and
epichlorohydrin. EPA also assumed the lead responsibility
for an assessment document on glycol ethers.
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Importing In December 1983, EPA published its policy statement (48
Chemicals FR 55462) under section 13 of TSCA, which explained
how EPA would interpret the U.S. Customs Service's
chemical substances import rule (48 FR 34734).
Section 13 of TSCA requires the Secretary of the
Treasury to refuse entry into U.S. Customs territory of any
chemical substance mixture, or certain article if it fails to
comply with any rule in effect under TSCA, or if it is
offered for entry in violation of section 5 or 6.
Under the Customs rule, an importer of a chemical
shipment must certify at the port of entry, for shipments
entering commerce in the U.S., that either:
• The shipment is subject to TSCA and complies with all
applicable rules and orders under TSCA; or
• The shipment is not subject to TSCA.
Under the Customs Rule, the EPA Administrator must:
• Determine whether detained shipments and their
entries comply;
• Notify Customs when EPA is aware of shipments that
should be detained;
• Identify steps necessary to bring detained shipments
into compliance, or that must be taken when shipments
are not brought into compliance; and
• Take action to store or dispose of abandoned
noncomplying shipments.
TSCA requires that chemical substances must be
included on the TSCA Inventory before they can be
imported into this country, unless it is solely for research
and development in small quantities. Persons who wish to
import chemical substances which do not appear on the
Inventory must comply with PMN requirements and
review procedures in the PMN Rule (40 CFR 720, 48 FR
21722).
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Appendix A
Summary/Guide to Information Required By Congress
Sections 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 found within this report are given here.
Section 30. This section contains the basic requirement for an
Annual Report and requests the following information:
(1) Testing. In FY 1984, EPA issued 14 negotiated testing
agreements. The Agency published 17 decisions not to test. In
addition, the Agency published five ANPRs, six notices of
Proposed Rulemaking, and 1 final rule.
(2) Premanufacture Notices (PMNs). EPA received 1,192 PMNs
during FY 1984 which brought the total received since the
program's beginning in mid-1979, to 4,201. (None of these
chemicals were subject to rulemaking under section 4.) In FY
1984, 24 cases underwent voluntary testing or control activities,
while 45 chemicals were subject to the development of either a
section 5(e) or 5(f) order (see section 3, New Chemicals, and
Table 1).
(3) Rules Issued under section 6. During FY 1984, ANPRs were
issued for four chemicals under section 6(a): (1) formaldehyde;
(2) 2-ethoxyethanol (2-EEA), 2-methoxyethanol (2-MEA), and their
acetates; and (3) 1,3-butadiene. Formaldehyde is used in
materials to construct mobile and conventional homes and in the
garment industry. 2-EEA and 2-MEA are used primarily as
solvents in paints, c'oatings, inks, and as deicers for jet fuels.
1,3-butadiene is another high-volume chemical that is used to
manufacture rubber and plastic products.
Under section 6(e) the following actions were taken: 1 ANPR;
5 proposed rules; and 3 final rules.
In addition, in FY 1984 EPA used the authority of section
5(f){2) to ban the addition of nitrites and/or nitrosating agents in
metalworking fluids in three immediately effective section 6(a)
rules.
(4) Judicial Actions under TSCA and Administrative Actions
under section 16. Judicial actions in FY 1984 involved PCBs,
formaldehyde, asbestos, and EPA's testing program under
section 4 of TSCA, Parts of the PCB litigation were settled, and
three additional petitions for review of rulemaking were filed
regarding PCBs. Three suits were filed to compel Agency action
regarding formaldehyde, asbestos, and EPA actions under its
section 4 testing program; The formaldehyde suit was
dismissed. The decision on the testing program has resulted in
the Agency's being ordered to undertake additional action. The
asbestos case is pending.
A total of 376 civil enforcement complaints were issued in FY
1984. In addition, there were three criminal and seven civil
referrals to the Department of Justice, and 1,349 Notices of
Noncompliance were issued (see Section 7, Compliance and
Enforcement).
44
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(5) Major Problems in Administering the Act. On August 23,
1984, the Federal Court and the Southern District of New York
rendered the opinion in a suit brought by the NRDC against EPA
(83 Civ. 8844 S.D.N.Y.), that Negotiated Test Agreements were
not a legal means of complying with section 4 of TSCA.
Under the new ruling, EPA will be required to promulgate test
rules or issue decisions not to test for chemical substances
which have been designated by the ITC for priority testing
consideration. Thus, the Agency will respond to the ITC's
designations initiating rulemaking proceedings by issuing
decisions not to require testing.
(6) Recommended Legislation. EPA considered possible
amendments to TSCA in FY 1984. This process will continue
during FY 1985.
Section 28(c). This section requires a report on grants to States
during the year. Six State Cooperative Agreement projects were
completed in FY 1984. These were undertaken by Maryland,
Puerto-Rico, Michigan, New York, and New Jersey (two
cooperative agreements). One additional State grant is due to be
completed in 1985.
Section 9(d). This section requires that EPA's efforts to
coordinate its TSCA activities with the related activities of other
Federal agencies be reported annually.
During FY 1984, EPA continued, in several formal and informal
agreements with other Federal government programs, to
address specific chemical activities. One of these efforts is
participation in the Federal Asbestos Task Force, of which
OSHA, the CPSC and EPA are charter members. The FDA,
National Institute of Occupational Safety and Health (NIOSH),
National Institute of Environmental Health Sciences, and the
National Cancer Institute joined during FY 1984. A second effort
includes the adoption of an interim policy for determining when,
and under what circumstances, EPA will refer chemical
problems to OSHA for its consideration. Preliminary steps have
also been taken to establish a Memorandum of Understanding
between OSHA and EPA in order to foster coordination, avoid
duplication, and ensure that chemical problems are handled
expeditiously under the most appropriate authority. Finally, EPA
began preparing two section 9(a) reports for consideration of
referral of 4,4'-MDA and 1,3-butadiene to OSHA.
In FY 1984, under joint agreements, EPA and NIOSH worked
on developing occupational exposure assessments on
1,3-butadiene, methylene bis(2-chloroaniline)—(MBOCA),
acrylamide, and 4,4'-methylenedianiline-(4,4'-MDA), and control
technology assessments on 1,3-butadiene and MBOCA, as well
as a respirator evaluation strategy for new chemical substances.
The purpose of these joint agreements is to use the
occupational expertise of NIOSH in EPA's assessment program.
In FY 1984 the Agency was instrumental in forming the IRMC
to examine high-priority solvents of concern not only to EPA, but
also to other regulatory agencies. The IRMC examines solvents
from a scientific policy standpoint in order to develop a coherent
position in regulatory strategy development for the Federal
government.
45
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Appendix B
Major FY 1984 TSCA Actions
Section Description
of Law
Date
4(a) For listing of testing decisions see Table 2
Good Laboratory Practice Standards 12/29/83
4(b) Testing Guidelines Published 9/24/84
4(f) Formaldehyde: Reconsiderations, Solicitation of 11/18/83
Comment Notice
1,3-butadiene: Initiation of Accelerated Review 1/5/84
Notice
Formaldehyde: Determination of Significant Risk 5/23/84
(Advance Notice of Proposed Rulemaking)
5(a) Substituted Polyglycidyl Benzeneamine (Proposed 12/29/83
Significant New Use Rule) (Corrected
1/31/84)
Substituted Methylpyridine and Substituted 1/3/84
2-phenoxypyridine (Proposed Significant New Use
Rule)
Dicarboxylic Acid Monoester (Proposed Significant 1/3/84
New Use Rule)
Derivative of Tetrachloroethylene (Proposed 1/3/84
Significant New Use Rule)
8-Acetyl-3-Dodecyl-7,7,9.9-Tetramethyl-1,3,8-Triaza- 1 /13/84
spiro-l4,5]Decane-2,4-dione (Proposed Significant
New Use Rule)
Substituted Methylpyridine and Substituted 2/6/84
Phenoxypyridine (Proposed Significant New Use
Rule)
Potassium N,N-Bis(Hydroxyethyl); Cocoamine Oxide 9/5/84
Phosphate and Tallowamine Oxide Phosphate (Final
Significant New Use Rule)
5(a) Alkyl Aryl Phosphine (Proposed Determination of 9/20/84
Significant New Use)
Hexamethylphosphoramide (HMPA) and Urethane Signed
(Proposed Determination of Significant New Use on 9/27/84
Existing Chemicals).
Substituted Bromothiophine (Proposed 9/28/84
Determination of Significant New Use)
Certain Chemicals (Proposed Determination of 9/28/84
Significant New Use); P-83-906 (Brominated Aryl
Alkyl Ether); P-83-908 (Ethylated Amino Phenol);
P-83-909 (Amino Phenol); and P-83-910 (Aniline
Ether)
5(e) Consent Order; Disubstituted Heterocycle - Use of 11/8/83
appropriate protective equipment by workers to
reduce inhalation exposure and reduce possible
carcinogenic effect.
Consent Order; Brominated Aryl Alkyl Ether - 11/22/83
Requires use of long-sleeved impervious protective
gloves and labeling during manufacturing and
processing.
46
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Section
of Law
Description
Date
Consent Order; Ethylated Aminophenoj - Requires 11/22/83
use pf long-sleeved impervious protective gloves and
labeling during manufacturing and processing.
Consent Order; Aminophenol - Requires use of 11/22/83
long-sleeved impervious protective gloves and '
labeling during manufacturing and processing.
Consent Order; Aniline Ether - Requires use of 11/22/83
long-sleeved impervious protective gloves and
labeling during manufacturing and processing.
Consent Order; Substituted Phenylacetamide - 12/7/83
Requires use of full face shield and long-sleeved
impervious gloves during processing.
Unilateral Consent Order; Alkyl-substituted aromatic 12/8/83
amine. Company withdrew instead of complying
with order.
Cqnsent Order; Alkyl Aryl Phosphine - Requires use 1/16/84
of NIOSH-approved air-supplied positive respirators
and protective clothing and gloves, restrictions on
liquid/solid waste handling, informing employees on
toxicity with written warning, and maintaining
records.
Consent Order; Unsaturated Aliphatic Diether - 1/23/84
Requires use of impervious gloves, that all
operations are conducted in a ventilated laboratory
bench hood, packaging to prevent leakage/and
maintaining records pending development of
information.
Consent Order; Trisubstituted Aniline - Requires use 2/29/84
of protective gloves, packaging to prevent spills,
labeling, and record maintenance pending
development of information.
Consent Order; Poly.ol Carboxylate Ester - Requires 4/9/84
impervious protective gloves, chemical safety
goggles, clothing over exposed body areas,
NIOSH-approved respirators, employee safety
meetings and labeling.
Consent Order; Aliphatic Trioj Ester Methacrylate - 5/25/84
Requires use of gloves, clothing over exposed body
areas, chemical safety goggles, employee safety
training program, labeling, approved disposal
procedures, and recordkeeping pending development
of information.
Consent Order; Polyester Acrylate Ester - Requires 5/25/84
use of gloves, clothing over exposed body areas,
chemical safety goggles, employee safety training
program, labeling, approved disposal procedures, and
recordkeeping pending development of information.
Consent Order; Aliphatic Acrylate Ester - Requires 5/25/84
use of gloves, clothing over exposed body areas,
chemical safety goggles, employee safety training
program, labeling, approved disposal procedures, and
recordkeeping pending development of information.
47
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Section Description Date
of Law
5(e) Consent Order; Polyether Acrylate - Requires use of 5/25/84
gloves, clothing over exposed areas, chemical safety
goggles, employee safety training program, labeling,
approved disposal procedures, and recordkeeping
pending development of information.
Consent Order; Aliphatic Ester Methacrylate - 5/25/84
Requires use of gloves, clothing over exposed areas,
chemical safety goggles, employee safety training
program, labeling, approved disposal procedures, and
recordkeeping pending development of information.
(2 Chemicals)
Consent Order; Halogenated Alkene - Requires use 6/13/84
of respirators if time weighted average airborne
concentrations are npt kept to 10 ppm, NIOSH-
approved respirator, impervious gloves, clothing over
exposed body areas, and employee safety meetings
pending development of information. (2 Chemicals)
Consent Order; Halogenated Alkane - Requires use 6/13/84
of respirators if time weighted average airborne
concentrations are not kept to 1 ppm, NIOSH-
approved respirators, impervious gloves, clothing
over exposed body areas, employee safety meetings
pending development of information.
Consent Order; Substituted Aromatic Polymer - 7/27/84
Requires use of impervious protective gloves,
clothing over exposed body areas, face shields,
employee safety training meetings, and
recordkeeping pending development of information.
(7 Chemicals)
Consent Order; Substituted Pyridine - Requires 8/6/84
venting vapor emissions outside work area, local
ventilation at drumming station, wearing
NIOSH-approved respirators, impervious suits,
gloves, face shields, and chemical goggles, and
employee safety training meetings pending
development of information. (2 Chemicals)
Consent Order; 8/13/84
Poly(OXY-1,4-butanediyl)-X-(1 -OXO-2-propenyl)
—w-[(1 -OXO-2-propenyl)OXY]-: Prohibits
manufacture, import, processing, distribution in
commerce, use and disposal for any non-exempt
commercial purpose except in accordance with the
order's detailed restrictions. Requires impervious
gloves, chemical or safety goggles, clothing over
exposed areas, employee safety training meetings,
and labeling.
Consent Order; 2-Chloro-N-Methyl-N-Substituted 8/13/84
Acetamide - Requires NIOSH-approved respirator,
impervious safety gloves, employee safety training
meetings, labeling, and recordkeeping pending
development of information.
Consent Order; Substituted Phenol - to be 8/13/84
manufactured, imported, and processed solely for
use on an antioxidant/ stabilizer for polymers.
Requires use of impervious gloves, employee safety
training meetings, labeling and recordkeeping
pending development of information.
48
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Section Description Date
of Law
Consent Order; Halogenated Aromatic Ether - 9/13/84
Manufacturing/ processing requires protective
equipment, employee safety equipment, employee
safety training meetings, labeling, and recordkeeping
pending development of information.
Consent Order; Substituted Oxirane - May present 9/25/84
carcinogenic and pulmonary edema hazard via
dermal exposure and inhalation. Requires personal
protective equipment at any site controlled by the
company, employee safety training meetings, and
recordkeeping.
Consent Order; Substituted Alkyl Halide May 9/25/84
present carcinogenic and pulmonary edema hazard
via dermal exposure and inhalation. Requires
protective equipment at any site controlled by the
company, employee safety training meetings, and
recordkeeping.
Consent Order; Perhalo Alkoxy Ether - May cause 9/25/84
pulmonary edema via dermal exposure and
inhalation. Requires protective equipment, employee
safety training meetings, and recordkeeping. (3
Chemicals)
Consent Order; Polychlorinated Alkylated Aromatic 9/26/84
Hydrocarbon-Requires protective equipment,
employee safety training meetings, labeling, and
record-keeping pending development of information.
Consent Order; 9/26/84
N,N,N'N'-Tetraglycidyl-1,3-bisaminomethyl
Cyclohexane Cannot be manufactured in USA.
Processing and use in USA requires personal
protective equipment, employee safety training
meetings, labeling and record-keeping.
Consent Order; Urea Condensate with 9/26/84
Poly[oxy(methyl-1,2-ethanediyl)]
Alpha-(2-aminomethylethyl)-omega-(2-aminomethyl-
ether)- Requires environmental controls pending
development of information.
5(f) Prohibition of Nitrites in Metalworking Fluids (2 1/23/84
and Chemicals): (Immediately Effective Proposed Rule)
6(a)
Triethanolamine Salt of a Substituted Organic 6/14/84
Acid-Restrictions on Use in Metalworking Fluids:
(Immediately Effective Proposed Rule)
Mixed mono and diamides of an organic acid 9/20/84
(Immediately Effective Proposed Rule)
6(a) 2-Methoxyethanol and 2-Ethoxyethanol and Their 1/24/84
Acetates; Initiation of Regulatory Investigation
(Advance Notice of Proposed Rulemaking)
1,3-Butadiene; Initiation of Regulatory Action: 5/15/84
(Advance Notice of Proposed Rulemaking)
Formaldehyde; Determination of Significant Risk 5/23/84
(Advance Notice of Proposed Rulemaking)
6(e) Polychlorinated Biphenyls (PCBs); Manufacturing, 11/1/83
Processing and Distribution in Commerce
Exemptions (Proposed Rule)
49
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Section
of Law
Description
Date
6(e) Polychlorinated Biphenyls (PCBs); Manufacture, 11/17/83
Processing, Distribution in Commerce and Use
Prohibitions; Use in Microscopy and Research and
Development (Proposed Rule)
Polychlorinated Biphenyls (PCBs); Exclusions, 12/8/83
Exemptions and Use Authorizations (Proposed Rule)
Polychlorinated Biphenyls (PCBs); Manufacture, 3/23/84
Processing, Distribution in Commerce and Use
Prohibitions; Use in Electrical Transformers (Advance
Notice of Proposed Rulemaking)
Polychlorinated Biphenyls (PCBs); Manufacturing, 7/10/84
Processing, Distribution in Commerce and Use
Prohibitions; Response to Individual and Class
Petitions for Exemptions (Final Rule)
Polychlorinated Biphenyls (PCBs); Manufacturing, 7/10/84
Processing, Distribution in Commerce, and Use
Prohibitions; Exclusions, Exemptions, and Use
Authorizations (Final Rule)
Polychlorinated Biphenyls (PCBs); Manufacturing, 7/10/84
Processing, Distribution in Commerce and Use
Prohibitions-Use in Microscopy and Research and
Development (Final Rule)
Polychjorinated Biphenyls (PCBs); Modification of 7/23/84
Definition of Totally Enclosed Manner for PCB
Activities (Proposed Rule)
Polychlorinated Biphenyls (PCBs) Manufacture, 10/11/84
Processing, Distribution in Commerce and Use
Prohibitions: Use in Electrical Transformers
(Proposed Rule) (signed in FY'84 and counted as
FY'84 output)
8(a) Preliminary Assessment Information: Amendment to 12/14/83
Include Four Chemicals from 13th ITC List (Final
Rule)
Preliminary Assessment Information: Manufacturer 1/12/84
Reporting Amendment Adding Mesityl oxide
(Proposed Rule)
Chlorinated Terphenyl, Submission of Notice of 3/26/84
Manufacture or Importation (Final Rule)
Technical Amendment to Above Rule 8/10/84
Preliminary Assessment Information: Amendment to 5/29/84
Include 14th ITC List (Final Rule)
Preliminary Assessment Information: Amendment to 6/25/84
Include llth ITC List (Final Rule)
Preliminary Assessment Information: Manufacture 6/25/84
Reporting Amendment Adding Mesityl Oxide (Final
Rule)
Chlorinated Naphthalenes - Submission of Notice of 8/24/84
Manufacture or Importation (Final Rule)
8(c) Records and Reports of Allegations That Chemical 8/22/83
Substances Cause Significant Adverse Reactions to
Health or the Environment; Recordkeeping and
Reporting Procedures (Final Rule)
50
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Section
of Law
Description
Date
8(d) Health and Safety Data Reporting: Amendment to
Add Four Chemicals From 13th ITC List (Final Rule)
Health and Safety Data Reporting: Submission of
Lists and Copies of Health and Safety Studies on Six
Chemicals on llth ITC List, and a Designated Mixture
Containing Substances from the 10th ITC List Final
Rule)
Health and Safety Data Reporting: Submission of
Lists and Copies of Health and Safety Studies on
Five Chemical Substances (Proposed Rule)
Health and Safety Data Reporting: Amendment to
Add Five Chemicals From 14th 11C List (Final Rule)
Health and Safety Data Reporting: Submission of
Lists and Copies of Health and Safety Studies on
Five Chemical Substances (Final Rule)
13
21
25
Chemical Importers and Exporters: Requirements
and Restrictions Policy for Import of Chemical
Substances (Final Rule)
Denial of Citizens' Petition-PCB Manufacturing,
Processing, Distribution in Commerce, and Use
Prohibitions (Final Rule-Related Notice)
Response to Citizens' Petition-Asbestos; Abatement
of Friable Asbestos Containing Materials in Schools;
Inspection/Abatement of Friable Asbestos Containing
Materials in Public/Commercial Buildings
Denial of Citizens' Petition to Delete Inorganic
Glasses as Mixtures, and Excluding from the TSCA
Inventory a Category of Substances Called Structural
Polymers (Including Inorganic Glasses) Classifying
These as Not Being Chemical Substances Per Se For
Inventory Purposes.
Receipt of Petition by the Natural Resources
Defense Council, Inc., That EPA Ban Use of
Asbestos in Original Equipment and Replacement
Brakes for On-Road Cars and Trucks.
Receipt of Citizens' Petition to Eliminate or Reduce
Disposal and Emission of Toxic Substances Into
Environment of Southeast Chicago From Multiple
Polluting Sources.
Indemnification Report to Congress On February 3,
1984, the Administrator sent the Indemnification
Report to Congress to fulfill section 25(a) of TSCA
which requires that EPA determine when, if ever,
the government should compensate people for
losses caused by EPA action. The report concluded
that there is no justification for expanding the
existing indemnification programs at EPA nor for
creating new programs. The primary reason is that
there are very few actual uncompensated losses.
Many potential losses are prevented, reduced, or
shifted by administrative action. Other losses are
compensable under a general statute, for example,
the Federal Tort Claims Act, the Tucker Act, or the
Equal Access to Justice Act.
12/14/83
1/13/84
2/16/84
5/29/84
7/27/84
12/13/83
1/13/84
3/07/84
9/20/84
Pending
9/30/84
Pending
9/30/84
2/3/84
51
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Section Description Date
of Law
Chemical Advisories
Notice of Potential Risk, Used Motor Oil (Published 2/84
in English and Spanish)
Notice to Formulators of Metalworking Fluids, 8/84
Potential Risk from Nitrosamines
Notice to Workers of Potential Risk, Nitrosamines in 8/84
Metalworking Fluids
Leaking Underground Storage Tanks Containing 8/84
Motor Fuels: A Chemical Advisory
52
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Appendix C
Section 4 Test Studies* Received
Alkyl phthalates
Chlorinated paraffins
4-chlorobenzdtrifluoride
2-chlorotoluene
Methyl isobutyl ketone
1,2-Butylene oxide
Chlorinated benzenes
2-phenoxyethanol
Chloromethane
Calcium napthenate
Cyclohexanone
Acetonitrile
*W2 studies on 12 chemicals
Appendix D
Summary Of NTP Studies
National Toxicology Program (NTP) Studies* Reviewed
1,1,1,2-tetrachloroethane
Benzene
tris (2-ethylhexyl) phosphate
1,3-butadiene
Diallyl phthalate
Hamamelis water (witch hazel)
8-hydroxyquinoline
HC Blue No. 1
Chlorodibromomethan©
Eugenol
1,3-dichloropropene
Dimethyl hydrogen phosphite
Crysotile asbestos
HC Blue No. 2
2-Ch!oro©thanol
*16 studies on 1§ chemicals
53
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Appendix E
Chemical Hazard Information Profiles (CHIPs) Prepared
Alkylated phenol sulfides, 8/84
Aminophenol (ortho-), 3/84
Aminophenol (para-), 3/84
Butylated hydroxytoluene, 8/84
Diallyl phthalate, 9/84
Diethylhexyl adipate, 9/84
Dihydrosafrole, 3/84
Epoxy/chlorohydroxypropyltrimethylammonium chloride, 7/84
Ethylenediamine tetra(methylene phosphonic acid), 2/84
Hydroxylamine, 9/84
Methyl bromide, 9/84
Methylcyclopentadienyl manganese tricarbonyl, 10/83
Methylene diphenyldiisocyanate (MDI), 6/84
Methylnitropropy W-nitrosoaniline, 12/83
Naphtha (Petroleum) solvents, 9/84
Quinoline, 12/83
Sulfolane, 6/84
Tetrachloro-1-propene (1,1,2,3), 9/84
Toluene diisocyanate (TDI), 7/84
Toluidine (ortho-), 2/84
Vinyl acetate, 5/84
54
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Appendix F
FY 1984 section 21 Citizens' Petitions
Date
Fled
Who
Filed
What Action
Requested
EPA.S Date of
Disposition Disposition
10/12/83 Cannelton
Industries, Inc.
That EPA amend its PCB regulations to provide Denied
EPA Regional Administrators authority to approve
alternate disposal methods for non-liquid PCBs,
including contaminated soils.
11/16/83 Service
Employees
International
Union (SEIU) of
AFL-CIO
6/15/83 Society of the
Plastics
Industry (SPI)
That EPA initiate rulemaking to require the Granted
abatement of Friable Abestos Containing
Materials (FACM) in public and private elementary
and secondary schools. In addition, provide
rulemaking concerning inspection and abatement
of FACM in public and commercial buildings.
That EPA amend the Inventory reporting rule by Denied
deleting the designation of inorganic gasses as
mixtures and excluding from the Inventory a
category of substances SPI calls structural
polymers, by classifying them as chemical
non-substances.
7/17/84 Citizens for a That EPA issue a rule to: Pending
Better 1. Clean up the Southeast section of Chicago, as of
Environment Illinois; 9/30/84
and 2. Conduct an investigation prior to rulemaking to
Irondalers study the health effects from many toxic
Against the substances in air, land, and water in the SE
Chemical Chicago area; and
Threat 3. Use TSCA authorities to assess and remedy ,
the public health situation as a whole, and not
with piecemeal regulations.
9/11/84 Natural That EPA ban the use of asbestos in original Pending
Resources equipment and replacement brakes for on-road as of
Defense cars and trucks. 9/30/84
Council, Inc.
1/13/84
49 FR 1697
3/7/84 49
FR 8450
6/14/84
49 FR 24552
9/20/84 49
FR 36844
55
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Appendix G
TSCA section 28 State Cooperative Agreements Program
State/
Department
Project Grant Descriptions and Status
Amount Grant Period
($)
Illinois
Department of
Public Health
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 16 counties are being
compiled. In one county, an investigation of birth outcome
and maternal history is underway. Illinois has been granted
a no-cost extension from June 1984 to June 1985.
475,626 3/81-6-85
Purpose: Develop a computer-based toxic substances
registry.
Maryland
Department of
Health and
Mental Hygiene Current Status: The registry now contains information on
250 chemicals, an incidents record, industrial survey
reports, all OSHA violations, birth defects data and a record
of all occupationally related diseases. The final report was
received and distributed.
Maryland Purpose: Develop a program to assure the safe and
Department of effective containment of toxic substances in storage tanks.
Health and
Mental Hygiene Current Status: Guidance and procedures manuals and an
implementation plan have been completed. Seminars have
been conducted. Final report received.
230,953 4/79-4/83
100,000 3/81-12-83
Michigan
Department of
Natural
Resources
Michigan
Department of.
Natural
Resources
Purpose: Develop an interdepartmental risk assessment 532,258 3/81-12-83
process intended for use by the Michigan Departments of
Agriculture, Natural Resources, and Public Health.
Current Status: The final report on the Interagency Risk
Assessment Process has been completed and received.
The risk assessment process is divided into two parts, the
actual risk assessment and risk management, which
includes an analysis as well as the course of action to take
to reduce or eliminate the risk. Specific elements of this
project included: the review of mathematical methods for
assessment of carcinogenic risk; methods for assessing
non-carcinogens; evaluation of environmental fate
processes, data acquisition, estimation and predictive
modeling for use in exposure evaluation; and individual
projects for development and management of general
investigatory information on occupational exposure, food
chain contaminants as well as specific studies on PCB silo
contamination and toxaphene in Michigan sportfish.
Purpose: Develop Critical Materials Program to prevent 504,500 4/79-9/82
and eliminate unreasonable exposure to toxic substances.
This was to be achieved through the development and
implementation of a computerized toxic substances data
system.
Current Status: This project has been completed. The final
report was received and a summary was distributed.
56
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State/
Department
Project Grant Descriptions and Status
Amount ($} Grant Period
New Jersey
Department of
Environmental
Protection
New Jersey
Department of
Environmental
Protection
Purpose: Set up toxic substances investigation and
integration unit; expand current project monitoring volatile
organic compounds in air.
Current Status: The Toxic Substances Investigation and
Integration Unit has identified and investigated various
hazardous waste sites in New Jersey. Cancer and birth
defects clusters have been investigated. The mobile
monitoring van is completed and is currently operating
throughout the State. Final reports on both projects have
been received.
Purpose: Study movement, distribution and uptake of
in-pface 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
done 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
has been completed. Summary reports of toxic substances
research and other educational materials have been
prepared and are now available. The study on mutagenic
assays performed on waste water samples has been
completed. Final reports on all these projects, as well as an
executive summary, have been received.
Purpose: Identify, characterize and plan for managing
toxic substances.
Current Status: The grantee proposed to use New York's
experience in the Niagara River Project as the basis for a
State-wide management plan. This proposal was revised to
include the State s experience in projects other than the
Niagara River, and to abstract from that Project only those
characteristics that can be reasonably expected to be
applicable to other sites around the State. A final report
was received.
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 substances posing an unreasonable risk.
Current Status: The project has been completed.
Chemical guidance packages have been received and
distributed
Puerto Rico Purpose: Develop and manage the Commonwealth's
Environmental toxic substances management strategy; expand an
Quality Board existing" public participation/awareness program.
Current Status: This project has been completed. A Public
Participation Plan was prepared which focused on a
seminar featuring the inclusion of PCBs, asbestos
substances and (TSCA) regulations to the Regulation for the
Control of Hazardous and Non-Hazardous Solid Waste
(State regulations), which was presented on October 6,
1983.
453,947 4/79-4-84
794,053 3/80-4/84
New York
Department of
Environmental
Conservation
348,000 4/79-6/84
385,000 3/80-12/83
258.394 3/80-10/83
Wisconsin
Department of
Health and
Social Sciences
Purpose: Study health problems related to formaldehyde
vapors from mobile home construction materials.
Current Status: This study is complete. The final report
was received and distributed.
202,947 4/79-9/82
57
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