United States
Environmental Protection
Agency
Office of Pesticides
and Toxic Substances
Washington DC 20460
Odobor 1989
EPA 560/1 89 001
Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Years
1987 and 1988
Printed on Recycled Ptpet
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TABLE OF CONTENTS
Introduction 1
Controlling Entry of New Chemicals 3
Identifying Existing Chemicals Which Pose 11
Unreasonable Risks
Regulation of Hazardous Chemical Substances
and Mixtures 25
Relationship of TSCA to Other Federal Laws 30
Compliance and Enforcement 36
Litigation 58
Other TSCA Activities 76
Tables
1. Summary of New Chemical Actions—FY '87 7
2. Summary of New Chemical Actions—FY '88 9
3. Summary of Section 4 Chemical Testing
Actions—FY '87 19
4. Summary of Section 4 Chemical Testing
Actions—FY '88 22
5. Administrative Civil Actions Taken Under
Section 16 of TSCA, Complaints Issued,
Cases Completed, and Amounts Assessed—FY '87 56
6. Administrative Civil Actions Taken Under
Section 16 of TSCA, Complaints Issued,
Cases Completed, and Amounts Assessed—FY '88 57
Appendices
A. Major FY '87 TSCA Actions 77
B. Major FY '88 TSCA Actions 84
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INTRODUCTION
When Congress enacted the Toxic Substances Control Act
(TSCA) in 1976, it gave the Environmental Protection Agency (EPA)
the authority to identify and control chemical hazards to human
health and the environment. This tenth Report to Congress
fulfills the reporting requirements for information about the
administration of the Act found in TSCA sections 30, 9(d) and
28(c) for Fiscal Years 1987 and 1988. An overview of other major
actions under TSCA is found in Appendices A and B.
On October 22, 1986, Congress added Title II to TSCA, by
enacting the Asbestos Hazard Emergency Response Act (AHERA).
Title II directs EPA to issue regulations affecting asbestos in
school buildings and requires the Agency to submit reports to
Congress on asbestos in public and commercial buildings and on
the availability of liability insurance for local education
agencies and asbestos contractors. The law enacted in 1976
became Title I.
TSCA Title I gives EPA the authority to gather certain basic
information on chemical risks from chemical manufacturers and
processors, and to require companies to test selected existing
chemical substances and mixtures (chemicals) for toxic effects.
It also requires EPA to review most new chemicals before they are
manufactured. The Office of Toxic Substances (OTS) is charged
with implementing TSCA.
Under TSCA Title I, EPA has implemented programs to:
evaluate chemicals prior to commercialization through
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premanufacture notification requirements for new chemical
substances and new uses of existing substances; evaluate existing
chemicals by requiring testing and the reporting of unpublished
health and safety data; and take appropriate control actions
after carefully weighing the risks of these chemicals against the
benefits they provide.
EPA may regulate a chemical at any point in its life cycle—
manufacturing, processing, distribution in commerce, use or
disposal.
To prevent unreasonable risks, EPA may select control
options that range from requiring hazard-warning labels to
outright bans on the manufacture or use of especially hazardous
chemicals.
This Report to Congress details EPA's progress in
controlling toxic chemical hazards to human health and the
environment under TSCA.
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CONTROLLING ENTRY OF NEW CHEMICALS
When it enacted section 5 of TSCA, the Congress wanted to
ensure that no new chemicals were introduced into the environment
until they had been reviewed for potential effects and subjected
to appropriate controls.
Consequently, under section 5(a), manufacturers,or importers
must notify EPA 90 days in advance if they intend to manufacture
a new chemical for commercial purposes. During the 90-day
premanufacture notification (PMN) period, EPA evaluates the
available information about the chemical.
If EPA's review finds few or insignificant risks, it allows
production of the chemical to begin without any action by EPA.
Ninety percent of the new chemicals reviewed by EPA fall into
this category. If EPA finds that there is insufficient
information to evaluate the risk, and that the manufacture or use
of the chemical may present an unreasonable risk to people or the
environment; or that the chemical is produced in large volumes
and there may be significant human exposure or release to the
environment, EPA is authorized to intervene. It may prohibit or
restrict the manufacture, processing, distribution in commerce,
use or disposal of the chemical, under section 5(e) of TSCA,
until the necessary data are developed.
Options used under section 5(e) include: (1) allowing the
PMN submitter to perform the needed tests before production, or
to control activities associated with the chemical as though it
had been tested and found as toxic as suspected; (2) requiring
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the submitter to perform tests before the chemical is produced;
and (3) requiring testing once production of the new chemical
reaches a prescribed level.
Finally, if EPA reviews a PMN containing sufficient data to
evaluate risk and determines that a new chemical presents an
unreasonable risk of injury, EPA can prohibit its manufacture,
processing, distribution, use or disposal.
EPA also may issue rules under section 5(a)(1) requiring
submission of a chemical for review before significant new uses
of the chemical may be initiated.
In Fiscal Year 1987, EPA received 2,334 new chemical
notices. These included 1,761 PMNs, 30 Test Market Exemption
Applications, 253 Polymer Exemption PMNs, and 276 Low Volume
Exemption Notices.
Sixty-one new chemicals were subjected to controls by the
development of either a section 5(e) order or 5(f) order limiting
or prohibiting their manufacture, processing, distribution in
commerce, or disposal.
In Fiscal Year 1988, EPA received 3,020 new chemical
notices, including 2,436 PMNs, 18 Test Market Exemption
Applications, 321 Polymer Exemption PMNs, and 237 Low Volume
Exemption Notices. Thirty-four new chemicals were subject to the
development of either a section 5(e) or 5(f) order. The total
number of new chemical notices received, since the program's
beginning in mid-1979, is 13,840. Of these, 392 chemicals have
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been subjected to controls by development of a section 5(e) or
5(f) order. Further, industry has voluntarily tested or taken
control actions on an additional 237 chemicals.
Tables 1 and 2, which follow, provide detailed summaries of
new chemical actions for both fiscal years. None of these
chemicals was subject to ruleraaking under section 4.
EPA has broadened its approach to new chemical regulation to
include action on large-volume chemicals with potential for high
human exposures or environmental releases, even in those cases
where there is no current indication of possible adverse effects.
Since February 1988, more than 50 large-volume new chemicals have
been subject to requirements for data on health or environmental
effects under the exposure-based authority of section
EPA also is enhancing its process for issuing significant
new use rules (SNURs) , which require reporting on chemicals
before manufacture or processing for significant new uses may
begin. A procedural rule that will commit the Agency to issuing
SNURs for certain types of chemicals has been proposed, and is in
the final stages of promulgation. The revised approach will
simplify the process, minimize the time it takes to issue SNURs,
make the SNUR program more consistent by establishing criteria
for issuance of SNURs, and establish standard language for
routine SNUR provisions, making the rule triggers easier to
understand, thus aiding compliance.
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EPA also is using section 5 to obtain information about
genetically altered microorganisms.
These organisms are considered "new", and are subject to
premanufacture notification rules if they are manufactured for
TSCA purposes •. Six PMNs were submitted during FY '87 and FY '88
for genetically altered microorganisms used in closed systems,
such as fermenters, that are not intentionally released to the
environment.
EPA also has received notices from persons releasing new
organisms to the environment during research and development. In
FY »87 and '88, EPA has reviewed 20 notices involving R&D
releases. All but one of these releases were proposed by one
company investigating enhancement of nitrogen-fixing bacteria.
EPA is presently developing a proposed rule that will define
a comprehensive approach to regulating microorganisms under TSCA.
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Table 1
Summary of New Chemical Actions
October 1, 1986 - September 30, 1987
Actions
Aggregate
Total To
No. of 09/30/87
Actions (since
in FY'87 mid-1979)
Total New Chemical Substance Submissions Received
(PMNS; Test Market, Polymer, and Low Volume)
Valid PMNs Received (includes Biotechnology)
PMNs Requiring No Further Action
Voluntary Testing in Response to EPA Concerns
Voluntary Control Actions by Submitters
PMNs Withdrawn in Face of 5(e)/5(f)
PMNs Subject to section 5(e) Consent Orders *
PMNs Subject to Unilateral section 5(e) Orders *
PMNs Subject to section 5(f) Rules
Number of Chemicals for which Commencement of
Manufacture Notices Were Received
Submissions of Bona Fide Intent to Manufacture
New Substances Subject to Proposed Significant
2,334
1,761
1,405
22
0
44
61
0
0
538**
399
1***
10,820
9,117a
7,166
151
45
183
348a
16
4
3,830a
3,030
56
New Use Rules (SNURs)
New Substances Subject to Final Significant
New Use Rules (SNURs)
Test Data Received as a Result of Section 5(e)
Consent Orders
0***
15
25
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Valid Test Market Exemption Applications Received 30 457
Granted 20 397
Withdrawn 4 40
Denied 1 7
Valid Polymer Exemption PMNs Received 253 640
No Further Action Required 212 540
Withdrawn 33 88
Converted to Conventional PMN 4 6
Valid Low Volume Exemption Notices Received 276 594
No Further Action Required 270 568
Withdrawn 4 15
Ineligible 1 1
a: Includes 106 synfuel PMNs.
* A section 5(e) consent order is issued by EPA with the agreement
of the PMN submitter. A section 5(e) unilateral 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 '87.
*** This number includes substances which were the subject of PMNs
received in previous fiscal years but for which proposed or final
rules were not published until FY '87.
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Table 2
Summary of New Chemical Actions
October 1, 1987 - September 30, 1988
Actions
Aggregate
Total
in FY'88
No. of to 09/30/88
Actions (since
in FY'88 mid-1979)
Total New Chemical Substance Submissions Received
(PMNS, Test Market, Polymer, and Low Volume)
Valid PMNs Received (includes Biotechnology)
PMNs Requiring No Further Action
^Voluntary Testing in Response to EPA Concerns
Voluntary Control Actions by Submitters
PMNs Withdrawn in Face of 5(e)/5(f)
PMNs Subject to section 5(e) Consent Orders *
PMNs Subject to Unilateral section 5(e) Orders *
PMNs Subject to section 5(f) Rules
3,020
2,436
1,858
41
0
78
34
0
0
13,840
ll,565a
9,024
192
45
261
382a
16
4
Number of Chemicals for which Commencement of
Manufacture Notices Were Received
Submissions of Bona Fide Intent to Manufacture
New Substances Subject to Proposed Significant
New Use Rules (SNURs)
New Substances Subject to Final Significant
New Use Rules (SNURs)
Test Data Received as a Result of Section 5(e)
Consent Orders
544** 4,374a
387 3,417
2*** 58
0***
15
31
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Valid Test Market Exemption Applications Received 18 475
Granted 18 415
Withdrawn 0 40
Denied 0 7
Valid Polymer Exemption PMNs Received 321 961
No Further Action Required 199 739
Withdrawn 46 134
Converted to Conventional PMNs 10 16
Valid Low Volume Exemption Notices Received 237 831
No Further Action Required 233 801
Withdrawn 8 23
Ineligible 0 1
a: Includes 106 synfuel PMNs.
* A section 5(e) consent order is issued by EPA with the agreement of
the PMN submitter. A section 5(e) unilateral 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 1988.
*** This number includes substances which were the subject of PMNs
received in previous fiscal years but for which proposed or final
rules were not published until FY 1988.
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IDENTIFYING EXISTING CHEMICALS WHICH POSE UNREASONABLE RISKS
In order to make high-quality, timely toxic chemical
management decisions, EPA must have the best available data.
Often such information is not available, yet EPA must make
decisions in the public interest despite these data gaps.
Sections 4 and 8 of TSCA provide some of the chemical testing
information needed to close these gaps and guide the
decisionmaking process.
Testing of Chemical Substances and Mixtures
Section 4 of TSCA authorizes EPA to require manufacturers or
processors of existing chemicals to test their health and
environmental effects.
To require testing EPA must find that: A chemical may
present an unreasonable risk of injury to human health or the
environment; insufficient data are available to reasonably
determine or predict the effects of the chemical, and testing is
necessary to generate this data. Alternatively, EPA may require
testing if the chemical is produced in substantial quantities and
it enters or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant or substantial human exposure to the chemical; data
are insufficient and testing is necessary to generate this data.
Most chemical testing candidates are suggested by the
Interagency Testing Committee (ITC), a committee created by TSCA
and composed of members of EPA and other federal agencies.
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Chemicals may also be nominated for testing by EPA program
offices.
If testing is needed, EPA obtains the necessary data by
developing a test rule or negotiating an enforceable consent
order. Both specify the chemical to be tested, effects being
tested, test standards, schedules for submission Of data, and
persons responsible for testing. .
In Fiscal Year 1987, EPA published 5 notices of proposed
rulemaking for the following chemicals: Cyclohexane; 2,6-di-tert-
butylphenol; oleylamine; 2-ethylhexanol, and 73 chemicals
nominated by the Office of Solid Waste (OSW). Testing of these
73 chemicals, which are constituents of hazardous waste, was
requested by OSW to support its efforts under the Resource
Conservation and Recovery Act to identify wastes that may be
hazardous to human health and the environment.
EPA issued 16 notices of final rulemaking for: 2-ethyl-
hexanoic acid; ethyltoluenes and trimethylbenzenes (C9 aromatic
hydrocarbon fraction); diethylenetriamine; mesityl oxide;
cresols; hydroquinone; biphenyl; anthraquinone; fluoroalkenes; ^
chlorinated benzenes; tetrabromobisphenol; oleylamine; propylene
oxide; commercial chemicals potentially.contaminated with
halogenated dibenzo-p-dioxins/dibenzofurans; and 2-ethylhexanol.
Dioxins and dibenzofurans were initially the subject of a
citizens' petition, filed under section 21 of TSCA by the
Environmental Defense Fund and the National Wildlife Federation.
The petitioners asked EPA to use its authority to analyze the
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hazards posed by multimedia releases of these chemicals, to take
action to reduce the risks from their release, and to test the
chemicals to the extent EPA determined information was lacking.
EPA denied the initial request to issue substantive rules,
but granted that part of the petition that requested testing.
EPA issued a final rule under sections 4 and 8 requiring certain
testing and submission of existing health and safety test data.
One enforceable consent order for 3,4-dichlorobenzo-
trifluoride was signed.
In Fiscal Year 1988, EPA published 3 notices of proposed
rulemaking for tributyl phosphate, isopropanol, and methyl ethyl
ketoxime. The Agency also published 10 notices of final
rulemaking for: 1,2-dichloropropane; benzyl butyl phthalate
(withdrawal of proposed rule); methylcyclopentane; diethylene
glycol butyl ether acetate; cumene; anilines (termination of
rulemaking); 2-mercaptobenzothiazole; commercial hexane;
diethylene glycol butyl ether; and 33 OSW chemicals.
Enforceable consent orders for methyl-tert butyl ether and
anilines also were signed.
For test rules promulgated in FY '87, EPA estimates that the
total testing costs over the life of the testing program will
range from $9.3 million to $11.4 million dollars. Costs for FY
•88 are estimated to range from $4.4 million to $6 million
dollars. These estimates do not include testing costs associated
with consent orders.
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Tables 3 and 4, which follow, provide a summary of these
specific testing actions.
While the major use of section 4 thus far has been to
respond to ITC recommendations for individual chemicals or
closely related categories of chemicals, OTS is placing new
emphasis on developing rules to obtain test data for other EPA
programs. In the past two years, test rules were developed for
the Office of Water and the Office of Solid Waste. Additional
proposals for the Office of Water are planned for 1989.
Another potential future source of section 4 testing
candidates is the Superfund Amendments and Reauthorization Act
(SARA). The Toxic Chemical Release Inventory requirements under
section 313 of the Act may reveal previously unrecognized
potential exposures to toxic chemicals for which little hazard
data are available.
Section 110 of SARA requires the Administrator of the Agency
for Toxic Substances and Disease Registry to coordinate SARA
research programs with the testing program under TSCA. The first
TSCA proposed test rule using this approach is being developed
with two federal agencies, the Agency for Toxic Substances and
Disease Registry and the National Toxicology Program. It is
expected to be proposed during 1990.
Since its creation, the section 4 testing program has
provided EPA with valuable data on the health and environmental
effects of chemicals. By the end of FY '88, EPA developed over
40 proposals, and completed 25 test rules and 3 testing consent
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orders. These test rules, and similar testing agreements
negotiated with industry, generated nearly 700 studies.
Reporting and Recordkeeping
Section 8 of TSCA, with its recordkeeping and reporting
requirements, gives EPA powerful tools for gathering information
about potentially toxic chemicals.
Under section 8(e) of TSCA, manufacturers, processors and
distributors of chemicals must notify EPA immediately if they
obtain information which reasonably supports the conclusion that
a substance presents a substantial risk of injury to human health
or the environment. In addition to these "substantial risk"
notifications, manufacturers may provide voluntary "for your
information" (FYI) submissions to EPA.
The section 8(e) program has been the most productive of all
section 8 authorities in identifying potentially hazardous
chemicals. Substantial risk notices may include preliminary
findings from toxicity testing programs, chemical effects on
humans in the workplace, and ecological effects data. More than
750 initial section 8(e) submissions, and more than 640 voluntary
"for your information" submissions from industry have been
received since TSCA's enactment.
In 1987, EPA received 60 initial section 8(e) submissions,
178 supplemental or follow-up section 8(e) submissions, and 159
FYI submissions. In 1988, there were 60 initial section 8(e)
submissions, 214 supplemental or follow-up section 8(e)
submissions, and 143 FYI submissions.
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Much of this information is shared, through an automatic
referral system, with other EPA program offices as well as the
Occupational Safety and Health Administration, Consumer Product
Safety Commission, Food and Drug Administration, National
Institute for Occupational Safety and Health, and National
Toxicology Program.
In addition to these automatic referrals, EPA may target a
chemical for action by a particular agency. In one case, EPA
received a section 8(e) submission for 4-chloro-2-methylaniline
(4-CMA), that raised concerns about bladder cancer in 4-CMA
workers. EPA recognized that these findings were relevant to its
assessment of a pesticide, chlordimeform, because 4-CMA is a
precursor and metabolite of chlordimeform. EPA and NIOSH are -
considering a risk notification program for current and former 4-
CMA and chlordimeform workers.
In another instance, EPA received section 8(e) data
indicating that n-butyl acetate, which was previously thought to
have a low order of toxicity, was acutely toxic. This
information was referred to OSHA, for use in its efforts to
update Permissible Exposure Limits.
Under TSCA section 8(d), EPA has developed a generic rule
that requires chemical companies to submit unpublished health and
safety studies on chemical substances and mixtures. Two types of
data are covered: Copies of all study reports in the possession
or control of the company; and lists of all ongoing company
studies, and ongoing or completed studies that the company is
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aware of but does not possess. Two hundred and forty-two
chemical substances and 15 categories had been added by amendment
to the generic section 8(d) rule by the end of FY '88.
EPA has been working to make its TSCA information gathering
rules useful to other EPA program offices and Federal Agencies.
A section 8(d) Health and Safety Data Rule listed 102 chemicals
of interest to OTS, other EPA offices, and the Consumer Product
Safety Commission.
Section 8(a) of TSCA allows the collection of production,
use, and exposure data from chemical manufacturers and
processors, and can require the retention of certain records.
One section 8(a) rule, the Preliminary Assessment
Information Rule (PAIR), allows EPA to collect readily obtainable
information needed for preliminary risk assessments on specified
substances. By the end of FY '88, EPA used PAIR to gather data on
approximately 380 chemical substances.
In an effort to coordinate information collection within EPA
and among other Federal agencies, EPA promulgated the
Comprehensive Assessment Information Rule (CAIR). This section
8(a) rule will be used to gather information to support the
assessment and regulation of chemicals. The first set of 19
chemicals subject to CAIR includes substances nominated by NIOSH
as well as by EPA. Additional substances, nominated by EPA or
other Federal agencies, will be added to CAIR in the future.
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Section 8(c) of TSCA requires manufacturers and processors
of chemical substances and mixtures to maintain records involving
allegations of adverse effects to human health or the environment
believed to have been caused by chemical substances or mixtures.
Any person may make such an allegation, which must then be
retained by industry.
EPA expects that individual companies will use the 8(c)
records to identify problems associated with the chemicals that
they manufacture, and take steps to resolve them.
This section also creates an historical record of
significant adverse reactions alleged to have been caused by a
chemical substance. EPA can inspect these records, and require
industry to report the information contained in them.
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Table 3
SUMMARY OF SECTION 4 CHEMICAL TESTING ACTIONS
FY '87
Testing in Response to the Interaaencv Testing Committee fITC)
Date
11/06/86
Chemical
2-Ethylhexanoic
acid
01/23/87
Ethyltoluenes
01/23/87
02/03/87
Trimethylbenzenes
(C9 aromatic hydro-
carbon fraction)
Diethylenetriamine
05/20/87
Cyclohexane
05/20/87
05/20/87
Mesityl oxide
Cresols
Action ITC List
Notice of Final Rulemaking; 14
requires testing for sub-
chronic toxicity, develop-
mental toxicity, and
pharmacokinetics studies.
Notice of Final Rulemaking; 10
specifies test standards and
reporting requirements^for
testing of the C9 aromatic
hydrocarbon fraction.
Notice of Final Rulemaking; 10
specifies test standards and
reporting requirements for
testing of the C9 aromatic
hydrocarbon fraction.
Notice of Final Rulemaking; 8
specifies use of EPA-modified,
industry-submitted plans
as the test standards and re-
porting requirements for this
testing.
Notice of Proposed Rulemaking; 18
proposes testing for subchronic
toxicity, developmental toxicity
neurotoxicity, dermal absorption
and dermal sensitization.
Notice of Final Rulemaking; 4
specifies test standards and
reporting requirements for
testing of this substance.
Notice of Final Rulemaking; 1
specifies test standards and
reporting requirements for
testing of ortho, meta and
para cresols.
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05/28/87
06/03/87
Hydroquinone
Biphenyl
06/04/87
Anthraquinone
06/08/87
Fluoroalkenes
06/25/87
07/01/87
2,6-di-tert-butyl-
phenol
Certain chlorinated
benzenes
07/06/87 Tetrabromo-
bisphenol A
Notice of Final Rulemaking; 5
specifies test standards and
reporting requirements for
testing this substance.
Notice of Final Rulemaking; 10
requires environmental effects
and chemical fate testing,
and announces adoption of
study plans and schedules
submitted by the Biphenyl Work
Group.
Notice of Final Ruleraaking; 15
requires manufacturers and
processors to conduct chemical
fate and environmental effects
testing, and to report annually
the volume manufactured or
imported during the latest
corporate fiscal year.
Notice of Final Rulemaking; 7
requires certain health effects
testing for the following
fluroalkenes: Vinyl fluoride,
vinylidene fluoride, hexaflu-
oropropene and tetrafluoro-
ethene, and also withdraws pro-
posed reproductive effects testing
for vinylidene fluoride.
Notice of Proposed Rulemaking; 18
proposes chemical fate and
environmental effects testing.
Notice of Final Rulemaking; 1/3
specifies test standards and
reporting requirements for
environmental effects testing
of 1,2,3- and 1,2,4-chloroben-
zene. The chemical fate testing
requirements, which were met as a
result of the proposed rule, are
withdrawn.
Notice of Final Rulemaking; 16
requires testing for chemical
fate and environmental effects.
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08/24/87
08/24/87
09/23/87
12/19/86
05/29/87
06/05/87
06/23/87
08/03/87
Oleylamine
Oleylamine
Propylene oxide
Notice of Final Rulemaking;
requires certain toxicity
testing of this chemical.
Notice of Proposed Rulemaking;
proposes TSCA test guidelines
be used as standards and pro-
poses deadlines for submission
of test data.
Notice of Final Rulemaking;
specifies test standards and
reporting requirements for
inhalation and developmental
toxicity testing.
13
13
Other Testing Actions
2-EthyIhexanol
Solid Waste
Chemicals
(73 Chemicals)
Halogenated
dibenzo-p-dioxins/
dibenzofurans
(HDDs/HDFs)
3,4-Dichlorobenzo-
trifluoride
2-EthyIhexanol
Notice of Proposed Rulemaking;
proposes 2-year oral oncogenicity
bioassays in rats and mice.
Notice of Proposed Rulemaking;
proposes testing for human health
effects and/or chemical fate in
support of EPA's hazardous waste
regulatory program under RCRA.
Notice of Final Rulemaking;
requires manufacturers and
importers to test 12 organic
chemicals for HDD/HDF contamina-
tion. Also requires testing
of 20 organic chemicals, not
currently manufactured or imported,
if manufacture or importation
resumes.
Consent Order; Occidental Chemical
Corporation agrees to perform
certain chemical fate and
environmental effects testing.
Notice of final rulemaking;
requires a 2-year oncogenicity
bioassay.
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Table 4
SUMMARY OF SECTION 4 CHEMICAL TESTING ACTIONS
FY_1M
Testing in Response to the Interagencv Testing Committee (ITC)
Date
Chemical
Action
ITC List
10/05/87 1,2-Dichloropropane
10/29/87 Benzyl butyl
phthaiate
11/12/87 Tributyl phosphate
02/05/88
02/26/88
03/16/88
Methy1eye1opentane
Diethylene glycol
butyl ether
acetate
Isopropanol
Notice of Final Rulemaking;
specifies test standards
and schedules for pharma-
cokinetic testing.
Withdrawal of Proposed Rule;
withdraws proposal to require
certain environmental fate
and effects testing, because
testing was completed by
industry.
Notice of Proposed Rulemaking;
proposes testing for health
effects, including neurotoxi-
city, mutagenicity, oncogeni-
city, dermal sensitization,
oral/dermal pharmacokinetics,
developmental and reproductive
toxicity. Also proposes
environmental effects and
chemical fate testing.
Notice of Final Rulemaking;
Terminates rulemaking for
methylcyclopentane because
EPA believes testing is not
necessary at this time.
Notice of Final Rulemaking;
requires testing for dermal
absorption.
Notice of Proposed Rulemaking;
proposes health effects testing
for oncogenicity, mutagenicity,
neurotoxicity, pharmacokinetics,
and subchronic, reproductive and
developmental toxicity.
18
10
13
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03/31/88 Methyl tert-butyl
ether
07/27/88 Cumene
08/19/88
Aniline and seven
substituted
anilines
08/19/88
Anilines
Consent Order; requires health
effects testing for mutagenicity,
pharmacokinetics, neurotoxicity,
oncogenicity, developmental
toxicity, reproductive and
fertility effects, and subchronic
effects.
Notice of Final Rulemaking;
requires health effects testing
including oral and inhalation
pharmacokinetics, subchronic
inhalation toxicity, develop-
mental toxicity and neurotoxicity.
Also requires environmental
effects and chemical fate tests
including acute toxicity to fish
and invertebrates, biodegradation
in an aquatic system, and volatili-
zation from an aquatic system.
Consent orders; require health
and environmental effects testing
for aniline and 2-chloroaniline,
health effects testing only for 2-
nitroaniline, 3,4-dichloro-
aniline, 2,4-dinitroaniline,
4-nitroaniline,, and 4-chloro-
aniline, and environmental
effects only for 2,6-dichloro-
4-nitroaniline.
Termination of rulemaking;
terminates proposed health effects
testing for 13 chemicals because
there is no basis for a finding
that any of these chemicals may
present an unreasonable risk of
injury to human health and no
substantial or significant human
exposure. Also terminates proposed
environmental effects testing for
17 chemicals, because there is no
substantial release to the
environment, or adequate data
are available.
19
15
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09/07/88
2-Mercaptobenzo-
thiazole
09/15/88
Methyl ethyl
ketoxime
Notice of Final Rulemaking;
requires health effects testing
for developmental and reproduc-
tive toxicity, neurotoxicity
and mutagenicity. Also requires
environmental effects and
chemical fate tests including
persistence and mobility, and
chronic aquatic toxicity.
Notice of Proposed Rulemaking;
proposes health effects testing
for oncogenicity, mutagenicity,
developmental toxicity, repro-
ductive effects, neurotoxicity
and pharmacokinetics.
15
19
Other Testing Actions
02/05/88
Commercial hexane
02/26/88
Diethylene glycol
butyl ether
06/15/88
Office of Solid
Waste chemicals
Notice of Final Rulemaking;
requires testing for oncogeni-
city, mutagenicity, neuro-
toxicity, inhalation and
dermal pharmacokinetics, also
subchronic, reproductive and
developmental toxicity.
Notice of Final Rulemaking;
requires testing for subchronic
toxicity with particular emphasis
on reproductive, hematological
and kidney effects, neurotoxicity,
developmental neurotoxicity
and pharmacokinetics.
Notice of Final Rulemaking;
requires subchronic toxicity
testing for 8 chemicals,
hydrolysis testing for 17, and
soil sorption testing for 7.
Also recommends anaerobic bio-
degradation testing for 32.
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REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES
EPA has the authority to prohibit or limit the manufacture,
import, processing, distribution in commerce, use or disposal of
a chemical that poses an unreasonable risk of injury to human
health or the environment. Under section 6, a number of possible
control options are available, ranging from total prohibition to
labeling.
Five section 6 rules were published in Fiscal Year 1987; an
additional 6 were published in Fiscal Year 1988.
Polychlorinated Biphenyls (PCBs)
Since the first PCB rules were published in 1978, EPA has
developed a comprehensive control program for these toxic
chemicals. EPA regulates every phase of PCB's existence through
rules that generally ban the manufacture, processing, and
distribution of PCBs in commerce; strictly limit the use of PCB-
containing electrical equipment, and require proper disposal of
PCBs. In FY '87 and FY '88, EPA expanded its PCB control program
to meet newly identified needs.
EPA promulgated its Polychlorinated Biphenyls Spill Cleanup
Policy on April 2, 1987 (52 FR 10688). The policy establishes
the measures that EPA considers adequate to clean up most PCB
spills that occur during activities regulated by TSCA.
EPA proposed (July 8, 1987; 52 FR 25838) and finalized
(June 27, 1988; 53 FR 24206) amendments to the PCB Exclusions,
Exemption and Use Rule. The final rule amends existing rules by
excluding additional materials containing less than 50 ppm PCBs
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from regulation under section 6(e). EPA has found that
activities allowed under the rule do not present unreasonable
risks of injury to public health or the environment.
EPA proposed (August 21, 1987; 52 FR 31738) and finalized
(July 19, 1988; 53 FR 27322) amendments to a rule governing the
use of PCBs in electrical transformers. The rule: (1) describes
the limited circumstances under which PCB transformers can be
installed in buildings; (2) prohibits the use of radial PCB (high
secondary voltage) transformers after October 1, 1990; (3)
requires that low secondary voltage network transformers located
in or near commercial buildings be removed from service by
October 1, 1993, if not equipped with enhanced electrical
protection; and (4) requires low secondary voltage transformers
located in sidewalk vaults be removed by October 1, 1993.
EPA has proposed a rule that would address 12 individual
and class petitions for exemption from the prohibition against
the manufacture, processing and distribution of PCBs in commerce.
The proposed rule (August 24, 1988; 53 FR 32326) would grant 8 of
the petitions and deny the remaining 4.
EPA also proposed a rule to amend storage and disposal
regulations covering PCBs (September 26, 1988; 53 FR 374360).
The proposed rule would improve the tracking system for PCB
wastes, and add an approval mechanism for commercial storers who
accept and store PCB wastes prior to their disposal.
EPA, in an action related to regulation of PCBs under
section 6, notified the Institute of Scrap Recycling Industries,
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Inc., and state and municipal officials of TSCA's prohibitions on
the manufacture, processing, distribution in commerce, use and
disposal of PCBs. The Agency took this action in spring, 1988,
when it became aware that some non-metallic shredded waste from
metal recycling operations (called "fluff") was contaminated with
PCBs. EPA responded to inquiries from industry, state and local
governments, and the Congress about the applicability of PCB
regulations, and to requests for additional Federal guidance.
Asbestos
EPA is one of several Federal agencies that regulates
asbestos, a substance which can cause cancer and chronic lung
disease. Together, they provide a comprehensive program that
protects workers and the public from asbestos exposure. Major
EPA rules address asbestos-containing materials in schools, and
protection of state and local government workers involved in
asbestos abatement activities. Rules developed in FY '87 and '88
broaden these protections.
Under section 6 of Title I of TSCA, EPA promulgated a final
rule that strengthens protection of state and local government
asbestos workers (February 25, 1987; 52 FR 5623). It establishes
requirements which must be followed during asbestos abatement
projects by employers of state and local government employees,
who are not otherwise covered by EPA or Occupational Safety and
Health Administration rules.
EPA also issued a final rule under Title II of TSCA (AHERA)
regulating asbestos-containing materials in schools
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(October 30, 1987; 52 FR 41826). It requires all local education
agencies to identify asbestos-containing materials and take
appropriate action to control the release of asbestos fibers.
In 1988 EPA released the draft Regulatory Impact Analysis
for the final rule on asbestos phaseout.
Hexavalent Chromium Chemicals
EPA proposed a rule (March 29, 1988; 53 FR 10206) that would
prohibit the commercial use of hexavalent chromium-based water
treatment chemicals in new and existing comfort cooling towers
(CCTs). The proposal also would prohibit their distribution for
use in comfort cooling towers. EPA is taking this action because
it has determined that the use of these chemicals in CCTs
presents an unreasonable risk of injury to human health and that
TSCA is the most effective means to control this risk. EPA has
determined that hexavalent chromium compounds are potent cancer-
causers in humans.
Risk to public health from hexavalent chromium air emissions
from CCTs typically would be addressed under the Clean Air Act
(CAA)- Consequently, pursuant to TSCA section 9, EPA-compared
the potential requirements for regulating these emissions-under
TSCA and the CAA to determine which was most appropriate. After
analysis, the Agency found that Section 6 provided the best
regulatory and enforcement options, that TSCA is the most
appropriate authority for this rulemaking, and that it is in the
public interest to protect against this risk under TSCA.
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Procedural Rule
EPA has proposed a rule to amend its procedural regulations
(June 17, 1987; 52 FR 23054) to clarify that rulemaking under
section 6 of TSCA may begin with publication in the Federal
Register of a notice of proposed rulemaking, an advance notice of
proposed rulemaking, or notice of other appropriate action
designed to lead to issuance of rules within a reasonable time.
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RELATIONSHIP OF TSCA TO OTHER FEDERAL LAWS
TSCA requires EPA to coordinate its activities with those of
other federal agencies involved in control of toxic chemicals.
During Fiscal Years 1987 and 1988, EPA worked with U.S.
government agencies, as well as representatives of other nations,
on complex chemical control issues.
Research
EPA has funded joint projects with the National Institute
for Occupational Safety and Health (NIOSH) to improve its ability
to assess exposure to chemicals regulated under the
Premanufacture Notification program. These studies contribute
significantly to the Agency's assessments of industrial exposure,
and to the development of new methods to evaluate exposure
control options.
Projects that were completed or are under way now include:
* A study of airborne exposure while using glove bags during
removal of asbestos-containing pipe coatings, and of the
potential to reduce exposures by improving design;
* A study of the effectiveness of technologies for reducing
asbestos exposure during brake maintenance;
* Development of improved monitoring techniques to measure
aerosol concentrations in biotechnology facilities;
* Surveys of facilities using acrylate formulations in inks
and coatings, to characterize exposure to a class of chemicals
frequently encountered in new chemical review;
* Surveys and monitoring of facilities using butadiene;
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* Research on respirators to determine actual workplace
protection factors.
EPA assisted the Department of Housing and Urban Development
(HUD) with the design and implementation of the HUD national
survey of lead-based paint in residences, as well as the HUD
lead-based paint abatement demonstration project, which will
measure the efficacy and cost of methods for reducing health
risks from exposure to lead-based paint.
The Agency also participated with the General Services
Administration (GSA), in a pilot study of inspection and
maintenance practices for managing asbestos in buildings, and in
a pilot program of inspection and training for managing of
asbestos in public buildings. In related activity, EPA and GSA
held a series of training sessions across the country to instruct
technical staff in proper inspection and management practices.
Another asbestos-related project was the development, with
the National Institute for Standards and Technology, of two
asbestos laboratory accreditation programs. One program covers
laboratories analyzing bulk materials from buildings to determine
their asbestos content; the other, laboratories that analyze the
asbestos content of air samples collected following asbestos
abatement projects.
Data Collection and Review
Senior managers of EPA meet regularly with senior managers
from the Occupational Safety and Health Administration (OSHA) and
NIOSH as part of the OSHA-NIOSH-EPA (ONE) Committee. Members of
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the ONE Committee have met about once a month for the past two
years to ensure coordination among the three Federal agencies
with responsibility for the Federal occupational health program.
The Committee's goal is, through discussion of risk assessment
and regulatory matters, and coordination of activities, to
operate the three programs as "One" national program. EPA
maintains the Chemical Activity Calendar database for the ONE
Committee, tracking information about some 1,200 chemicals that
are or may be considered for testing or regulatory action.
During 1987 and 1988, EPA, the Agency for Toxic Substances
and Disease Registry (ATSDR), the National Toxicology Program
(NTP), and the Oak Ridge National Laboratory reviewed data for
chemicals of mutual interest to agencies under TSCA, as well as
the Superfund Amendments and Reauthorization Act for chemicals on
the National Priority List. In coordination with the other
agencies, EPA assisted ATSDR in preparing toxicological profiles
of these chemicals and submitted them for joint agency review.
EPA and NTP sponsored a Workshop on the Relationship Between
Short-term Test Information and Carcinogenicity in January, 1987.
The workshop provided the data that are needed to update the
mutagenicity testing scheme used to determine test requirements
under sections 4 and 5 of TSCA.
EPA has helped other agencies meet its standards for
cleaning up spills of polychlorinated biphenyls (PCBs). EPA
reviewed PCB plans for the Department of Interior, the General
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Services Administration, military facilities, the Department of
Energy, and the U.S. Customs Service.
During 1987 and 1988, EPA participated in the interagency
Biotechnology Science Coordination Committee. This group, with
members from the U.S. Department of Agriculture (USDA), National
Science Foundation (NSF), National Institutes of Health (NIH),
and Food and Drug Administration (FDA), met concerning EPA's
development of a regulatory program on biotechnology products.
EPA also coordinated its review of microorganisms subject to
the TSCA Premanufacture Notification program with several
agencies to assure the safety of microbial products, while
minimizing impediments to technological and economic advances in
biotechnology. EPA consulted, on a case-by-case basis, with
USDA, FDA, NIH and the Consumer Product Safety Commission (CPSC).
Before completing its assessment of a microorganism's potential
risk to human health or the environment, EPA obtained comments
from the appropriate agencies.
EPA's Office of Toxic Substances leads an interagency
committee on chlorinated solvents, whose members are drawn from
EPA offices, OSHA, CPSC, and FDA. The committee's goals are to
determine whether chlorinated solvents present an unreasonable
risk of injury to human health and the environment, and whether
regulatory controls are needed to eliminate or reduce exposures
to them. Four major use categories are being studied: Dry
cleaning, solvent cleaning, paint stripping, and aerosols.
Analyses of the first two categories have been completed.
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Frequently, chemicals reported to EPA under the new
chemicals program raise workplace exposure concerns. EPA
coordinates its efforts to provide adequate hazard communication
and worker training with OSHA. The Agency's goal is to ensure
that EPA's requirements parallel OSHA's Hazard Communication
Standard.
EPA participated in OSHA's efforts to update Permissible
Exposure Levels for workplace exposure to certain chemicals. EPA
reviewed the proposed standards, focusing on obtaining broad-
based scientific feedback on chemicals for which there are
potentially serious scientific or policy issues, and reported its
findings to OSHA.
International Activities
EPA played a lead role in the design, planning and
implementation of the EXICHEM data base, introduced by the
Organization for Economic Cooperation and Development (OECD) in
November, 1987. This data base contains information from member
countries of OECD on ongoing and planned activities on existing
chemicals. • . - ,
EPA also participates in OECD chemical-specific information
clearinghouses which facilitate the exchange of information among
member countries. EPA manages two of these clearinghouses, and
actively contributes to the others.
EPA also regularly contributes data to the WHO/International
Programme on Chemical Safety (IPCS) data base called Computerized
Listing of Chemicals Being Testing for Toxic Effects (CCTTE).
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This data base carries information of ongoing or recently
performed toxicological research, such as chronic and subchronic
health effects studies. IPCS distributes it world-wide to help
prevent duplication of testing.
The Agency is now engaged in discussions on a cooperative
testing program regarding dinitrotoluenes with the Federal
Republic of Germany, and multilateral discussions are underway to
identify overlapping data needs on paradichlorobenzene.
EPA has worked with the government of Mexico on building a
hazardous waste/PCB incinerator in Tijuana, and has provided
engineering support for the project. The Agency will assist
Mexico in 1989 when tests of the new facility begin.
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COMPLIANCE AND ENFORCEMENT
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, as authorized by section 16 of TSCA.
Program Action
During FY 1987, EPA developed and issued compliance
monitoring strategies for the TSCA section 8(a) Inventory Update
Rule and the proposed CAIR Rule. EPA also developed and issued a
TSCA section 8, 12, and 13 Enforcement Response Policy (ERP), as
well as a clarification of the TSCA section 5 ERP (Notices of
Commencement).
In addition, EPA continued cooperative enforcement programs
to monitor compliance with the PCB regulations in the following
States: California, Connecticut, Florida, Iowa, Kansas,
Maryland, .Michigan, Missouri, New Hampshire, North Dakota, Ohio,
Puerto Rico, Texas, and Washington. EPA also continued
cooperative enforcement agreements to monitor compliance with
Asbestos-In-Schools regulations in the States of Arizona,
Colorado, Iowa, Maryland, New Hampshire, Oklahoma, Texas, West
Virginia, and Wisconsin. In FY 1987, the states conducted 1,143
PCB compliance inspections and 877 Asbestos-In-Schools compliance
inspections.
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The Oklahoma Asbestos-In-Schools and the Florida PCB
cooperative enforcement agreement programs were completed in FY
1987.
In FY 1988, a compliance monitoring strategy was developed
and issued for TSCA Title II (AHERA). EPA amended the compliance
monitoring strategy for the Asbestos Abatement Projects Worker
Protection Rule and the PCB Strategy, and proposed revisions to
the TSCA Good Laboratory Practice (GLP) regulations.
EPA developed and issued a revised Policy ERP for TSCA
section 5; an ERP for the Immediately Enforceable Provisions of
AHERA; a policy on the transition from the Asbestos-In-Schools
Rule (AIS) to AHERA, and a clarification of the TSCA section 6
PCB ERP.
EPA continued cooperative enforcement programs to monitor
compliance with the PCB regulations in the States of California,
Connecticut, Iowa, Kansas, Maryland, Michigan, Missouri, New
Hampshire, New Mexico, North Dakota, Ohio, Puerto Rico, Texas,
and Washington; as well as cooperative enforcement agreements to
monitor compliance with Asbestos regulations in the states of
Arizona, Colorado, Idaho, Iowa, Maryland, New Hampshire,
Oklahoma, Texas, Vermont, West Virginia, and Wisconsin. In FY
1988, the States conducted 1,253 PCB compliance inspections and
468 asbestos compliance inspections.
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Compliance Actions
In FY 1987 and FY 1988 EPA conducted a broad range of
inspections for TSCA requirements.
In FY 1987, EPA, along with 14 state agencies cooperating
under the terms of enforcement grants-in-aid, conducted 2,616 PCB
compliance monitoring inspections. In addition, the Agency,
operating under a cooperative agreement with the American
Association of Retired Persons, and the States of Arizona,
Colorado, Iowa, Maryland, New Hampshire, Oklahoma, Texas, West
Virginia, and Wisconsin conducted 2,694 Asbestos-In-Schools
inspections.
EPA also monitored compliance with TSCA sections 4, 5, 8,
and 13. EPA inspected 13 laboratories conducting testing under
TSCA to determine if the laboratories were in compliance with GLP
requirements. During these inspections EPA conducted 21 audits
of health and environmental tests to determine if testing had
been conducted according to test protocols, and if reports
accurately reflected study findings. EPA also conducted over 814
inspections to determine compliance with sections 5 and 8
requirements. The Agency conducted a total of 864 inspections to
determine compliance with section 13, chemical import require-
ments .
In FY 1988, EPA, along with 14 state agencies cooperating
under the terms of enforcement grants-in-aid, conducted 2,554 PCB
compliance monitoring inspections. In addition, the Agency,
operating under a cooperative agreement with the American
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Association of Retired Persons, and the states of Arizona,
Colorado, Idaho, Iowa, Maryland, New Hampshire, Oklahoma, Texas,
Vermont, West Virginia, and Wisconsin, conducted 1,233 Asbestos
inspections.
The Agency also monitored compliance with TSCA sections 4,
5, 8, and 13 requirements. EPA inspected 17 laboratories to
determine if they were in compliance with GLP requirements.
During these inspections EPA conducted 29 audits of health and
environmental tests to determine if testing had been conducted
according to test protocols, and if reports accurately reflected
study findings. EPA also conducted over 816 inspections to
determine compliance with section 5 and 8 requirements. The
Agency conducted a total of 673 inspections to determine
compliance with section 13, chemical import requirements.
International
During FY '88, EPA entered into "Memoranda of Understanding"
with the United Kingdom, Switzerland and Japan regarding Good
Laboratory Practices. Each agreement calls for the reciprocal
recognition of each country's good laboratory practice compliance
program, acceptance of test data generated in each country for
evaluation of safety, and implementation of procedures for
continuing mutual cooperation between the countries. The
Memoranda of Understanding were signed with Japan in September
1987, with the United Kingdom in March 1988, and with Switzerland
in June 1988.
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Civil Enforcement Actions
In FY 1987, a total of 1,051 administrative complaints were
issued. For failure to comply with the import certification
requirements (section 13) the Agency issued 25 civil
administrative complaints. The Agency issued 563 civil
administrative complaints for alleged violations of the section 6
asbestos-in-schools requirements and 445 administrative
complaints as a result of PCS inspections. In addition, EPA
issued 5 civil complaints for alleged violations of section 8 and
13 civil complaints for violations of section 5.
In FY 1988, the Regions and Headquarters issued a total of
607 administrative complaints. For failure to comply with the
import certification requirements (section 13) the Agency issued
20 civil administrative complaints. The Agency issued 81 civil
administrative complaints for alleged violations of the section 6
asbestos requirements and 475 administrative complaints as a
result of PCB inspections. In addition, EPA issued 11 civil
complaints for alleged violations of section 8 and 15' civil
complaints for violations of section 5. Moreover, 5 civil
complaints were issued for violations of Section 4.
' Figures for each EPA Regional Office and Headquarters appear
in Tables 5 and 6.
The following are case summaries of significant TSCA civil
administrative and judicial cases concluded during FY 87 and
FY 88.
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United States v. Alveska Pipeline Service Company (No. 86-4427;
D.C. No. CV86-583-F, 9th Circuit Court of Appeals)
EPA filed a Motion To Show Cause in the District Court of
Alaska to require the Alyeska Pipeline Service Company to comply
with an investigative subpoena issued to Alyeska, in response to
allegations that they were mishandling chemical substances or
waste materials. In December, 1987, Chief Judge Fitzgerald, of
the District Court of Alaska, issued a written opinion upholding
the Agency's authority to use TSCA section 11 subpoenas to
conduct investigations. The decision is the first written
decision of any court concerning EPA's TSCA subpoena authority.
The decision was upheld in January, 1988 by the Ninth Circuit
Court of Appeals.
U.S. v. Texas Eastern Transmission Corporation (Civil Action 88-
1917, lodged with the U.S. District Court, Houston, TX)
This action requires Texas Eastern Transmission Corporation,
which owns and operates a natural gas pipeline system that
stretches from the Gulf Coast to the northeast United States, to
pay a civil penalty of $15 million, the largest amount ever
obtained for violation of an environmental statute.
In late 1987, EPA initiated enforcement action against Texas
Eastern to obtain remediation of contamination caused by
discharge of liquids contaminated with PCBs and other pollutants
to earthen pits and other sites along the pipeline system. On
June 10, 1988, ,a Consent Decree was lodged with the District
Court settling the Agency's enforcement action. The provisions
of the Consent Decree establish several important precedents for
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EPA enforcement activities. In addition to payment of the civil
penalty, Texas Eastern is required to complete an investigation
and cleanup of all compressor station sites and other
contaminated areas. The estimated $400 million cost for
characterization and remediation is the largest commitment for
environmental cleanup ever obtained from a single company. Texas
Eastern also is required to implement extensive modifications to
pipeline equipment and operating procedures, and to pay up to $18
million to fund the oversight of characterization and remediation
activities.
American Telephone and Telegraph Company (Docket No. 87-H-09)
This action was brought seeking civil penalties for the
illegal production and use of two chemical substances that the
American Telephone and Telegraph Company (AT&T) had manufactured,
without first listing the chemicals with the TSCA Chemical
Substances Inventory, as required by section 5 of TSCA. A civil
penalty of $2.65 million dollars was sought in the complaint.
Although AT&T voluntarily disclosed the violations to EPA, EPA
viewed these violations as serious because the Agency was
precluded from conducting required premanufacture safety review
of the chemicals before the substances were manufactured and
distributed in commerce. In the settlement, AT&T agreed to pay a
civil penalty of $1.0 million dollars and to implement a number
of specific types of compliance activities, including: Corporate-
wide employee education concerning TSCA requirements, payment of
all costs for a number of public service announcements about TSCA
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requirements applicable to the electronics and semiconductor
industry, and the initiation and completion of a comprehensive
TSCA compliance survey audit at all AT&T domestic facilities.
The compliance survey, which began in July, 1987, will assess
compliance with sections 5, 8(a), 8(c), 8(d), 12, and 13 of TSCA.
EPA retained the authority to initiate criminal enforcement
actions or actions to abate situations involving imminent hazards
during the term of the compliance survey. For violations
discovered by AT&T as the result of the audit, AT&T agreed to pay
as a stipulated penalty the sum of $10,000 for each chemical
found to be in violation of any or all of TSCA section 5, 8(a),
8(c), 8(d), 12, or 13, unless EPA determines that the chemical or
chemical substances presents an unreasonable risk of injury to
health or the environment. For chemicals identified in the
survey and found by EPA to represent an unreasonable risk, EPA
reserved the right to seek penalties of up to $1.0 million per
chemical.
Canon U.S.A. Incorporated (Docket No. 86-H-03)
Canon U.S.A. of Lake Success, New York, the American
subsidiary of the Japanese Canon Corporation, was charged in this
administrative complaint with violations of TSCA section 5
premanufacture notice requirements and the section 13 import
certification requirements. These violations arose in connection
with the manufacture and import into the United States of two
photocopier toners containing chemical substances not listed on
the TSCA inventory. The complaint sought a civil penalty of $1.6
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million dollars. Canon voluntarily disclosed the violations to
EPA upon their discovery.
The consent agreement negotiated in the Canon case requires
the payment of a civil penalty of $400,000 and the initiation and
satisfactory completion of a number of items of specific
performance, including: Development and implementation of a
training program on U.S. requirements; translation of EPA TSCA
requirements, regulations and guidance documents into the
Japanese language; and presentation of a comprehensive seminar on
American TSCA requirements for Japanese businesses involved in
the export of chemicals to the United States. This seminar was
held in Tokyo, Japan in the spring of 1987 and included the
participation of several representatives of EPA's Office of
Pesticides and Toxic Substances.
DeLonghi America. Inc. (Docket No. 87-H-04)
This action concerns the illegal import, sale, distribution
in commerce and export of oil-filled portable electric space
heaters from Italy by. DeLonghi. The violations were initially
discovered by Environment Canada. EPA tests confirmed that
several shipments of heaters contained oil contaminated with high
levels of PCBs. The import of PCBs and PCB items was banned in
1980. Since these heaters were sold in commerce for home use,
EPA considered the violations to be serious. EPA issued a civil
administrative complaint for the assessment of a $1,507,000
penalty for these violations. DeLonghi entered into a consent
agreement with the Agency on June 8, 1988. The agreement
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requires DeLonghi to pay a penalty of $500,000 for the illegal
import and export. In addition, DeLonghi will send out notices
to 70,000 warranty card holders, informing them that the heaters
with serial numbers 86-20 or lower may contain PCBs. A toll-free
phone number to assist consumers and retailers with questions
about the handling and disposal of these appliances will be set
up. A quality assurance program to ensure that future imports
are PCB-free will also be established.
Exxon Chemical Americas (Docket No. 86-H-02)
This action charged Exxon with three violations of TSCA for
failure to submit a notice of its intention to manufacture a new
chemical substance as required by TSCA section 5. Exxon provided
the Agency with batch production records revealing that it had
manufactured and used for a commercial purpose a chemical
substance not listed on the TSCA inventory. The complaint sought
a civil penalty of $34,350. In settlement, Exxon agreed to pay a
civil penalty of $22,000 and to destroy all remaining quantities
of the illegally produced chemical substance.
Mitsubishi International Corporation (Docket No. 86-H-04)
This complaint charged Mitsubishi International with the
illegal import of a chemical substance on nine separate occasions
prior to the submission of a Premanufacture Notice (PMN), as
required by TSCA section 5, and of violation of the U.S. Custom
Service regulations promulgated pursuant to TSCA section 13. An
adjusted gravity based penalty of $280,000 was proposed. In
settlement of this action, Mitsubishi agreed to pay a civil
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penalty of $98,000 and to return 31,000 pounds of the
unregistered chemical to Japan.
BASF Corporation and BASF Inmont Division (Docket No. TSCA
87-H-05)
The Agency issued an administrative civil complaint against
BASF Corporation and one of its divisions, Inmont, seeking a
civil penalty of $4.3 million dollars for violation of the TSCA
section 5 and 13 requirements when it imported seven chemical
substances into the United States without completing the
premanufacture notice requirements of TSCA and for false
certification of U.S. Customs Service import certifications.
Manufacturers or importers are required to notify the Agency of
their intent to manufacture or import new chemicals so the Agency
can evaluate any hazards posed by the chemicals before they are
manufactured or brought into the United States. This was the
sixth civil complaint filed against BASF or its subsidiaries for
violations of TSCA, and the proposed penalty included an
increased civil penalty for prior TSCA violations, in eonformance
with the Agency's TSCA Civil Penalty Policy. This penalty was
the largest ever sought under TSCA for violations other than
PCBs. EPA has not disclosed which chemicals are involved, the
amounts produced or actual uses, because such information has
been claimed as confidential business information under TSCA
section 14.
In lieu of a trial, BASF agreed to settle this action by
paying a civil penalty of $1,281,950 and to conduct a corporate-
wide environmental audit of more than 150 domestic facilities.
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In addition, BASF agreed to pay for the publication of TSCA-
compliance public service announcements in approved trade
publications and to sponsor two training seminars on U.S. TSCA
requirements for European manufacturers who ship chemicals to the
United States. The seminars were presented at no cost to members
of the Verbund Chemischen Industries (VCI) in Frankfurt, West
Germany in 1988. The environmental compliance audit is due to be
completed in March, 1989. BASF has agreed to disclose all
violations of TSCA discovered during the course of the audit and
to pay stipulated penalties for violations.
U.S. v. Hollowav Oil Company (Case No. 88-59-CIV-J-14)
The United States District Court for the Middle District of
Florida handed down a Summary Judgment Order which will
substantially bolster administrative enforcement. EPA filed an
administrative enforcement action against Holloway in May 1985,
charging the company with numerous PCB violations. When the
company failed to submit a pre-hearing exchange, a Default Order
was entered in December 1985 imposing a $26,000 penalty. In
January, 1988, EPA filed an action in federal district court for
collection of the unpaid penalty and for a permanent injunction
to compel compliance with the PCB regulations.
The Court ruled that TSCA prohibits reconsideration of an
administrative law judge's penalty assessment in the context of a
penalty collection action filed in federal district court. The
Court noted that under TSCA, Holloway could have filed a petition
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for judicial review of the administrative penalty assessment
within 30 days of the final assessment. Having failed to act
within that period of time, Holloway forfeited its right to
challenge that assessment.
Boliden Metech. Inc. v United States (Case No. 88-0081L, D.C. of
Rhode Island)
On September 20, 1988, the District Court of Rhode Island
issued a decision that supports the Agency's authority to obtain
administrative search warrants under TSCA, potentially under
other environmental statutes which give the agency inspection
authority.
In July, 1987, EPA issued an administrative complaint
against Boliden Metech, a precious metal salvage company. The
company, located on the Providence River in Rhode Island is
storing shredded computer waste containing PCBs in large
uncovered piles in violation of TSCA storage and disposal
regulations. EPA is concerned about the amounts of PCBs which
tests show to be present in the shredded metal. An
administrative hearing seeking a civil penalty was held in March,
1988 and a decision is pending.
To develop additional data on the extent of the PCBs at the
site and to document PCB releases, EPA attempted to inspect the
site in January, 1988. Boliden refused to allow the inspection,
and EPA obtained a search warrant. The company then sought an
injunction in the District Court of Rhode Island asking that the
search warrant be declared illegal, and to have the Court direct
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the EPA to return all of the samples obtained during the
inspections. The company also asked the District Court to
declare that EPA lacks the authority to obtain search warrants
under TSCA because the statute does not explicitly state such
authority. EPA and the Department of Justice vigorously
contested Boliden's position. The Court denied the company's j
argument, and clearly supported EPA's use of search warrants.
U.S. v. N.O.C. Inc./Noble Oil (Case No. 87-3539 (CSF)
The District Court of Mew Jersey has ordered Noble Oil to
pay a penalty of $40,000, plus interest for PCB violations
discovered in 1980.
This action went to an EPA administrative hearing in 1982.
Upon being found liable by the Administrative Law Judge Noble
appealed first to the EPA Judicial Officer, then to the Court of
Appeals for the Third Circuit and then to the U.S. Supreme Court.
The Supreme Court denied certiorari in June of 1986 in the first
TSCA enforcement case ever appealed to the Supreme Court.
In this important decision, the District Court recognizes
the clear authority of the government to seek to collect civil
penalties that have been administratively assessed. The Court,
however, while acknowledging that it cannot review the amount or
appropriateness of the penalty, did recognize that it has the
jurisdiction to review issues associated with the appeal.
Villanova University (Docket No. TSCA-III-159)
In this action, EPA sought penalties of $28,000 against
Villanova University for a variety of violations of the PCB
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regulations including: Failure to maintain annual documents
($13,000); improper disposal (leak) ($5,000); and failure to
properly store PCBs ($10,000). The PCB storage area consisted of
neoprene rubber sheeting placed over steel beams.
In evaluating the appropriate civil penalty for the
violations an Administrative Law Judge determined that the
appropriate penalty for failing to conduct PCB transformer
inspection (pre-1983) was $1,500 and failure to maintain records
of the inspections was $2,000. A penalty of $2,000 was imposed
for the improper storage area, for a total penalty of $5,000.
The Judge also noted that Villanova was quick to remedy the
violations and that it had spent about $250,000 to remove PCBs
and PCB equipment from the University.
Eastman Chemicals Division. Eastman Kodak Company (Docket
No. 88-H-07)
Eastman Chemicals, Kingsport, Tennessee, was charged in an
administrative civil complaint on September 16, 1988, with
manufacturing four chemical substances that were not listed on
the TSCA Chemical Substance Inventory. TSCA section 5 requires
companies to notify the Agency 90 days prior to manufacturing a
substance that is not listed on the inventory. This allows the
Agency to conduct a health and safety review on the substance
before it is manufactured. The civil complaint proposed a
penalty of $1,260,000. Eastman discovered and voluntarily
disclosed the violations to the Agency. This matter is pending.
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Estron Chemicalf Incorporated (Docket No. TSCA 88-H-08)
Estron Chemical, Inc., Calvert City, Kentucky, was cited in
an administrative civil complaint on September 26, 1988, for
failing to notify the Agency prior to manufacturing a chemical
substance that was not listed on the TSCA Chemical Substance
Inventory. The complaint proposes a penalty of $135,000. The
Agency's National Enforcement Investigations Center discovered
the violations during an inspection of the company's facilities.
3M Company (Docket No. 88-H-06)
On September 2, 1988, EPA issued an administrative civil
complaint against the Minnesota Mining and Manufacturing (3M)
Company of St. Paul, Minnesota, assessing a $1,394,500 proposed
penalty for violations of sections 5 and 13 of TSCA. The
violations were voluntarily disclosed by 3M. EPA cited 3M with
failing to notify EPA prior to the importation of two chemical
substances that were not on the TSCA Inventory. The complaint
also cites the company for falsification of certified statements
/that were provided to the Customs Service district director at
the port of entry representing the true compliance of the
chemical substances.
Enforcement Actions Involving Criminal Violations of TSCA
In both Fiscal Year 1987 and Fiscal Year 1988, there were
seven ongoing investigations of criminal violations of TSCA or
regulations promulgated thereunder. There were other criminal
cases relating to TSCA offenses but because TSCA only provides
misdemeanor penalties, charges were brought under other
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environmental statutes, which provide more severe felony
penalties, principally the Resource Conservation and Recovery Act
(RCRA). In 1987 and 1988, the following individuals or
corporations were convicted or pled guilty to violations of TSCA:
United States v Robert E. Derecktor (District of Rhode Island.
Case No. 86-022)
On December 29, 1986, Mr. Robert E. Derecktor, the president
of Robert E. Derecktor of Rhode Island Inc., was sentenced upon
his guilty pleas to various counts of a 46-count indictment that
had been filed on May 20, 1986, charging criminal violations of
six environmental statutes, including TSCA. The company is the
operator of a shipyard for the building and repairing of vessels
located on Coddington Cove in Middletown. The company had been
charged in the indictment with violations of TSCA regarding PCBs
and transformers from the shipyard which were found buried at a
farm in Portsmouth occupied by Robert E. Derecktor. Mr.
Derecktor, on his plea of guilty to four counts of violating
TSCA, was sentenced to a fine of $25,000 on each of three counts
for a total of $75,000. On the fourth count, imposition of a
term of imprisonment was suspended and he was placed on probation
for five years, with a special condition that he certify monthly
in writing to his probation office that the corporation is not in
violation of any environmental laws. The company's environmental
compliance is being monitored by the Agency.
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United States v. Mervln Pollock (Western District of Missouri,
Case No. 87-00148-01-CR-W-8)
On September 3, 1987, Mr. Merlyn Pollock pled nolo
contendere to two TSCA misdemeanor counts of disposing of
electrical equipment that contained PCBs, a violation of TSCA
sections 15 and 16 (b) . Mr. Pollock had been indicted on June 23
for burying a high voltage switch and a capacitor, along with a
variety of RCRA hazardous wastes, on his property. On November
9, 1987, Mr. Pollock was fined $35,000 and placed on two years
probation.
United States v. Patrick W. Paciesas (Southern District of
Ohio, Case No. 87-0059)
On August 3, 1987, Mr. Patrick W. Paciesas pled guilty in
front of U.S. Magistrate Robert A. Steinberg to a one-count
information charging him with the knowing and willful disposal of
PCB-contaminated oil in a manner not authorized by law, in
violation of TSCA section 15, 16 (b) and 40 CFR Part 761.60, a
misdemeanor. Mr. Paciesas was president of Sea Bright
Environmental Company, Inc., which is involved in the removal,
transportation and disposal of hazardous waste and the
decommissioning of electrical transformers and capacitors. As
president, he was involved in the dumping of the PCB-contaminated
oil onto the ground. On September 28, 1987, Mr. Paciesas was
sentenced to two years probation, 100 hours of community service
and mandatory enrollment in an alcohol treatment program.
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United States v. Freeman Krum. (Middle District of
Pennsylvania, Case No. 87-0071)
Mr. Freeman Krum pled guilty on May 12, 1987, to a criminal
information filed under TSCA in the District Court for the Middle
District of Pennsylvania. Mr. Krum agreed to plead on three
misdemeanor charges for the illegal storage and disposal of PCBs
and failure to maintain PCB inventory records as required by
TSCA. Due to Mr. Krum's advanced age and ill health, the Court
sentenced Mr. Krum to eighteen months probation for these
offenses and directed that he no longer engage in any business
activity relating to the handling or disposal of PCBs or other
hazardous wastes.
United States v. Patrick Perrin (Western District of Missouri,
Case No. 87-00187-01-CR-W-9)
On July 20, 1988, Patrick Perrin was sentenced to two years
in prison, as a consequence of his February 4, 1988, guilty plea
to one count of conspiracy to violate the federal laws and
regulations relating to the use, treatment, transportation,
storage, and disposal of PCBs. Perrin was the plant manager for
the Martha C. Rose Chemical Company in Holden, Missouri which
transported and disposed of, among other things, electrical
transformers, capacitors and oil containing PCBs.
On August 20, 1987, Perrin was indicted on two conspiracy
counts, one count of making false statements to the government,
and three counts of violating TSCA's rule concerning disposal of
PCBs (40 C.F.R. Part 761.60). The evidence showed that Perrin
from 1983 through 1986 altered and falsified labels on barrels
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containing PCBs to attempt to deceive EPA inspectors as to
whether PCBs were properly disposed of within the one year time
period required by EPA regulations. Company documents were also
altered to falsely indicate that PCB items delivered to the
facility had been properly disposed of. The company would then
seek payment for such purported lawful disposal.
united States v. John Plantan (Southern District of Ohio,
Case No. CR-1-88-002)
On July 25, 1988, John Plantan was sentenced, subsequent to
his May 20, 1988, guilty plea to one misdemeanor count for the
illegal disposal of PCB-contaminated material, to one year in
jail (suspended), and two years probation. Mr. Plantan was also
required to place a notice in the Cincinnati newspaper outlining
his guilt in violating environmental laws (TSCA sections 15 and
16 (b), and to notify those he has done business with of his
guilt. Plantan was an associate of Patrick Paciesas, president
of Sea Bright Environmental Services, Inc., an Ohio corporation
which was involved in the removal, transportation and disposal of
hazardous waste and the decommissioning of electrical
transformers and capacitors.
During ,1983, in Cincinnati, Ohio, Plantan supervised the
company practice of discharging PCB-contaminated oil on the
ground from electrical units and from fifty-five gallon drums
obtained by Sea Bright Environmental Services.
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Table 5
FY '87
Administrative Civil Actions Taken Under Section 16
of TSCA, Complaints Issued, Cases Completed, and
Amounts Assessed (by Regions)*
Total
No. No. Total No.
Complaints Complaints Cases
Issued Issued Completed
Region FY'79-87 FY'87 FY'79-87
Total
Total Civil Penalties
No. Cases Total No. Penalties (In $)
Completed of Cases Collected collected
In FY'87** Pending ($) in FY'87 FY'79-87
1
2
3
4
5
6
7
8
9
10
HQ
160
478
271
297
801
307
405
326
210
253
41
50
128
78
113
186
86
144
111
61
82
12
98
334
192
174
601
256
177
190
163
85
29
24
93
58
31
171
96
34
54
64
15
9
62
144
79
123
200
51
228
136
47
168
12
289,215
418,297
456,892
40,385
442,640
223,424
305,070
275,270
366,335
136,976
1,782,500
772,950
2,824,112
1,260,697
469,912
5,679,519
1,759,669
816,105
736,785
1,058,790
575,071
3,737,250
TOTAL 3,549
1,051
2,299
649
1,250
4,737,004
* All actions taken involved alleged violations of sections 4,5,6,8, and 13.
** Includes cases carried over from FY 1980 - FY 1986.
19,690,860
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Table 6
FY '88
Administrative Civil Actions Taken Under Section 16
of TSCA, Complaints Issued, Cases Completed, and
Amounts Assessed (by Regions)*
Total
No. No. Total No.
Complaints Complaints Cases
Issued Issued Completed
Region FY'79-88 FY'88 FY'79-88
TOTAL 4,156
607
Total
Total Civil Penalties
No. Cases Total No. Penalties (In $)
Completed of Cases Collected collected
In FY'88** Pending ($) in FY'88 FY'79-88
1
2
3
4
5
7
8
9
10
HQ
187
564
338
349
921
366
461
387
239
295
49
27
86
67
52
120
59
56
61
29
42
8
122
445
224
204
721
299
229
302
202
118
37
24
111
32
30
120
43
52
112
39
33
8
65
119
114
145
200
67
232
85
37
177
12
467,439
730,205
311,416
201,585
448,027
109,100
81,075
196,880
254,130
248,435
2,077,765
1,240,389
3,554,317
1,572,113
671,497
6,127,546
1,868,769
897,180
933,665
1,312,920
823,506
5,815,015
2,903
604
1,253
5,126,057 24,816,917
* All actions taken involved alleged violations of sections 4,5,6,8, and 13.
** Includes cases carried over from FY 1980 - FY 1987.
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LITIGATION
Lawsuits are filed against EPA under TSCA either to compel
EPA to undertake certain actions or to invalidate actions the
Agency has already taken.
In the past, the greatest amount of defensive litigation
under TSCA involved PCBs. There was extensive litigation on PCB
rulemaking resulting from the 1980 decision invalidating EPA's
original PCB rules. All PCB litigation after 1980, however, has
resulted in EPA's agreeing to conduct additional rulemaking.
Fiscal year 1988 has seen the end for all practical purposes of
the PCB litigation resulting from the 1980 decision. Currently,
there is only one significant active PCB lawsuit, a challenge to
EPA's approval of a PCB disposal facility in Henderson, Kentucky.
Occasionally, defendants in PCB administrative enforcement cases
appeal judgments to the Court of Appeals.
Lately, the most significant cases are those challenging EPA
actions under section 4(a) of TSCA to require testing of
chemicals. Nine cases have been filed altogether. Two were
filed in the early stages of the Agency testing program by a
public interest group, The Natural Resources Defense Council.
The earliest case, in 1980, compelled EPA to increase the speed
of its testing program. The next case, in 1984, invalidated
aspects of EPA's negotiated testing agreements. Seven cases have
been filed over the past few years by the industry groups
challenging test rules. Three, fluoroalkenes, ethylhexanoic
acid, and mesityl oxide, have resulted in opinions by the Court
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of Appeals. One, cumene, was being actively briefed as of the
end of fiscal year 1988. The other cases are in various stages
of settlement.
EPA has been sued under the section 21 citizens' petition
provision to compel the Agency to regulate dioxins, to require
testing of certain chemical substances present in the environment
of the southeast area of Chicago, to regulate asbestos in
buildings, and to amend its PCB regulations. The dioxin case has
been settled. The asbestos case was effectively mooted by the
passage of Title II of TSCA, the Asbestos Hazard Emergency
Response Act (AHERA), which dealt with the issues raised in the
suit. The Chicago testing case is still pending, after having .,.,.
originally been filed in 1985. Procedural motions are pending in
the PCB case. EPA successfully defended-its asbestos in schools
regulation mandated under the Asbestos Hazard Emergency Response-
Act (AHERA).
. A petition for review was filed several years ago with
respect to the first significant new use rule under section
5(a)(2). That case has been settled. :
Polvchlorinated Biphenvl rPCB) Rulemaking
In 1979, the Environmental Defense Fund (EOF) petitioned for
review of EPA's regulations governing the manufacture,
processing, distribution, and use of PCBs. A decision largely in
EDF's favor was issued on October 30, 1980, EOF v. EPA, 636 F.2d
1267 (D.C. Cir.).
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As a result of the Court's orders in this case, EPA issued
three additional PCB rules. In 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 discharged into wastes that are disposed of in an
acceptable manner; finally, in July 1984 EPA issued a regulation
affecting other PCBs inadvertently generated in chemical
manufacturing processes. These rules, in turn, have generated
other litigation and other regulation.
Fiscal years 1987 and 1988 litigation developments are
described below.
August 1982 Electrical Equipment Rule. Previous TSCA Annual
Reports described the litigation and subsequent additional rules
resulting from the August 1982 rule. PCB rulemaking activities
in fiscal years 1987 and 1988 are the result of a rule issued in
July 1985, which placed additional restrictions and conditions on
the use of PCB transformers in order to prevent risks from fires.
MISSISSIPPI POWER COMPANY V. EPA (No. 85-4498, 5th Cir.)
Under the settlement EPA proposed a rule in August 1987 amending
the July 1985 rule to allow approximately one additional year to
phase out or institute measures to protect one class of PCB
transformers. The final rule was promulgated July 19, 1988. On
September 16, 1988, Mississippi Power withdrew its petition for
review, thus ending this phase of the litigation.
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Julv 1984. Inadvertent Generation Rule, in late September
1984, petitions for review of the July 1984 rule were filed 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.
The Seventh Circuit petition was transferred to the D. C. Circuit
where the Court consolidated all cases — AMERICAN PAPER
INSTITUTE V. EPA (No. 84-1481, D.C. Cir.) and CONSOLIDATED CASES.
The Chemical Manufacturers Association was granted permission to
intervene. A settlement agreement was filed with the Court in
August 1986 by most of the parties. EPA agreed to propose and
obtain public comment on amendments to allow certain activities
involving existing stocks of very low level PCB products and
materials.
EPA also agreed to make a final decision on the proposal
within specified time frames. The settling parties agreed to
dismiss the case if EPA would issue a final rule substantially
similar to the proposed amendments. The Court was asked to hold
the proceeding in abeyance until the rulemaking could be
completed.
Pursuant to the settlement agreement, EPA issued a proposed
rule in July 1987. A final rule was issued in June 1988, which
satisfied the concerns of all petitioning parties. The court is
expected to formally conclude this case during fiscal year 1989.
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Citizens' Petitions
Service Employees International Union (SEIU1 v. Ruckelshaus. (No.
84-2790, D.D.C.)
In November 1983, SEIU filed a citizens' petition under TSCA
section 21 requesting EPA to issue rules affecting asbestos in
schools and in public and commercial buildings and rules to
protect employees performing abatement activities. In response
to this petition EPA eventually issued rules to protect certain
state and local government employees engaged in asbestos
abatement. With respect to the other rules requested by SEIU,
EPA stated that it granted the petition, initiated a proceeding
by holding hearings to decide on its next course of action, and
ultimately decided not to proceed toward proposed rules.
SEIU filed suit, in September 1984, in U.S. District Court
to compel issuance of the other rules it requested for schools
and other public and commercial buildings.
After several years of litigation, the court ordered EPA to
propose the rules requested by SEIU for both schools and other
buildings. The court reasoned, in an October 24, 1986 opinion,
that EPA was obligated to propose rules because the Agency had
represented that it granted SEIU's petition. The court
interpreted TSCA and EPA's procedural regulations to require the
Agency to propose a rule when it grants a section 21 petition to
issue rules under TSCA section 6(a).
At approximately the same time as the court issued its
opinion, AHERA was enacted. AHERA required EPA to issue
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regulations affecting asbestos in schools and to submit a study
to Congress which would assess the risks of asbestos in other
public and commercial buildings and recommend whether rules were
appropriate for those buildings also.
AHERA created some inconsistencies with the court order.
While EPA was able to comply with the order affecting schools by
meeting the AHERA mandate, AHERA created a conflict with the
court's order as it applied to non-school public and commercial
buildings. The order required proposed rules; AHERA only
mandated a study. In June 1987, at EPA's request and in
deference to Congress, the court vacated its order regarding
non-school buildings.
EPA complied with both AHERA and the district court order by
promulgating rules affecting asbestos in schools. EPA
successfully defended these rules against a challenge in the
United States Court of Appeals for the District of Columbia
Circuit. See Safe Buildings Alliance v. EPA. 846 F.2d 79 (1988).
This case is explained below.
In February 1988, EPA submitted to Congress its study on
public and commercial buildings, concluding that rules were not
yet appropriate for those buildings. SEIU, thereupon, petitioned
the district court to clarify or reconsider its June 1987 order
vacating the requirement for EPA to propose rules for public and
commercial buildings.
Before the court could hear the parties on this motion, EPA
and SEIU settled the district court litigation. The U.S.
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Government paid SEIU approximately $220,000 in attorneys fees and
SEIU agreed that EPA no longer had any obligations with regard to
the SEIU petition. EPA agreed to consider, in accordance with
TSCA section 21, any further SEIU petitions on asbestos in public
and commercial buildings.
Environmental Defense Fund (EOF) and National Wildlife Federation
(NWF1 V. Thomas. (No. 85-0973, D.D.C.)
Plaintiffs brought this action after EPA had denied, in
part, their TSCA section 21 citizens' petition to issue
comprehensive regulations under TSCA on certain isomers of the
chemicals known as dioxins. These are substances chemically
similar in structure to 2,3,7,8-tetrachlorodibenzo-p-dioxin
(TCDD) and which, according to plaintiffs, may present risks
similar to TCDD.
In early 1986 plaintiffs filed a motion requesting the Court
to order EPA to initiate rulemaking because the Agency's
explanation published in the Federal Register was improper as a
matter of law- EPA opposed plaintiffs' request arguing that its
denial was in accordance with statutory requirements. In March
1987, the Court denied plaintiffs' motion, stating that under
TSCA the form of the denial does not affect the type of judicial
action permitted under TSCA section 21. The court reasoned that,
when EPA denies a section 21 petition, plaintiffs are only
entitled to a de novo proceeding before the Court, regardless of
the reasons stated by the Agency.
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In July 1988, EDF and NWF reached a settlement with EPA
under which the Agency agreed, within specified time frames over
a number of years, to undertake certain actions relating to
dioxins. Some actions would be under TSCA authority, but many
would be taken under authority of other Agency-administered
statutes. Specifically, EPA agreed to consider the appropriate
Agency actions to take with respect to (l) commercial chemicals
that testing shows are contaminated with dioxins, (2) activities
at pulp and paper mills that could cause dioxin contamination,
(3) wastes from the wood preservative industry, and (4) air
emissions from municipal waste combustors. In addition, EPA
agreed to issue studies on hospital waste incinerators.
In September 1988, EDF and NWF filed an appeal from the
district court's opinion that they were only entitled to a de
novo proceeding when EPA denied their petition.
At the end of fiscal year 1988, the parties were engaged in
discussions related to settlement of attorneys fees in the
district court litigation.
Citizens for a Better Environment, et al. v. Lee M. Thomas.
(No.85 C 08000, N. 111.)
In September 1985, two public interest groups challenged
EPA's decision denying their petition filed pursuant to section
21 of TSCA in April 1985. The petition had requested EPA to
identify business entities in the southeast area of Chicago which
were releasing 11 named chemical substances into the environment
and to initiate rulemaking under TSCA section 4(a) to require
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testing on the chemical substances — including testing for
cumulative and antagonistic effects.
EPA denied the petition, in part, on the basis that there
are no available test standards for studying cumulative effects
of chemical substances. In addition the denial notice indicated
that health effects data were adequate for regulatory assessment.
Finally, the notice stated that EPA had already identified 44
businesses in southeast Chicago which emit pollutants into the
air, and that EPA was conducting a variety of environmental
investigations in southeast Chicago.
The discovery process, wherein each side may request
documents and depositions from the other side, is reaching its
final stages.
Two steel companies, which had intervened as defendants,
filed a motion to dismiss the complaint in July 1988. They
argued that TSCA section 21 violates the separation of powers
doctrine of the U.S. Constitution because it authorizes a federal
district court to order EPA to initiate ruleraaking after a de
novo trial. Plaintiffs argued that section 21 was no different
from any other statute allowing a court to review agency decision
making. This motion was pending before the court at the end of
fiscal year 1988.
Dr. David G. Walker v. EPAf (No. H-87-3552; S.D.Tex., Houston)
In March 1987, Dr. Walker filed a citizens' petition under
TSCA section 21 asking EPA to exclude from its current
regulations polychlorinated biphenyls (PCBs), containing three
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chlorine atoms or less. EPA denied the petition on the grounds
that in previous proceedings involving PCBs the Agency had
already considered, and rejected, the arguments raised by Dr.
Walker. The court is currently considering various procedural
motions raised by EPA and plaintiff.
PCB Activities
Michael D. Vanderveer and Citv of Evansville. Indiana v. EPA and
Unison Transformer Services. Inc.,
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EPA argues that its approval was in accordance with its TSCA
regulations and that TSCA is the appropriate authority to approve
the Unison facility. The parties are awaiting the court's
decision.
Jack Pierce, d/b/a Jack Pierce Waste Oil. Inc. v. EPA.
(No. 86- 1486, 7th Cir.)
Jack Pierce sought review of a $29,000 penalty assessed by
EPA for violation of the Agency's PCB disposal regulations.
Pierce challenged EPA's determination that he owned the tanks
from which PCBs spilled and the legal conclusion that he could be
held personally liable for a violation alleged to be caused by
his business. The case was settled under an agreement whereby
EPA received a civil penalty payment of $14,000 and agreed to
vacate its decision on personal liability.
New Orleans Public Service. Inc. fNOPSI) v. EPA. (No. 86-4577,
5th Cir.)
NOPSI sought review of a penalty assessed by EPA for
improper disposal of PCB-contaminated transformers. NOPSI
claimed it was not the owner of the transformers, which were
being removed by the building owner when the spill occurred. The
Court reversed the Agency's penalty order and remanded the case
for further proceedings. The Agency will not seek further
review.
U.S. v. Cannelton Industriesf Inc., (No. 83-2406, S.D.W.Va) and
Consolidated Cases.
This group of three cases resulted from a spill of PCBs from
a transformer in an underground mine operated by Cannelton. EPA
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filed a complaint alleging Cannelton violated the Agency's
regulations regarding disposal of PCBs. Cannelton filed two
suits against EPA. One suit requested that the court declare
Cannelton's rights and responsibilities with respect to storage
and disposal of PCBs in its mine. In the second suit Cannelton
requested the Court to order EPA to initiate a proceeding to
amend its PCB disposal rules. EPA and Cannelton reached an
agreement on cleanup of the PCBs, which was approved by the Court
in February 1986. The court has retained supervisory jurisdic-
tion over the agreement.
Challenges to Agency Rulemaking;
Chemical Manufacturers Association v. EPA. (No. 84-1569, D.C.
Cir.)
On November 19, 1984, the Chemical Manufacturers Association
(CMA) filed a petition for review of the first significant new
use rule EPA promulgated under section 5(a)(2) of TSCA. The
rule, promulgated on September 5, 1984 (49 PR 35011), related to
two chemical substances which were the subject of premanufacture
notices under section 5 of TSCA. The rule also included general
procedural provisions that will be applicable to all significant
new use rules. In the course of informal discussions, CMA
indicated that it was concerned about some of these procedural
provisions. EPA indicated that it was willing to undertake
further rulemaking on these provisions which was likely to meet
these concerns. Accordingly, CMA agreed to defer briefing until
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EPA proposed revisions to these procedural provisions. The
revisions were proposed on April 22, 1986.
CMA and EPA entered into a settlement agreement under which
CMA agreed to voluntarily dismiss its action if EPA promulgated
revisions substantially similar to those proposed. EPA issued
the revisions in question on July 27, 1988, and CMA moved to
dismiss its petition for review on September 2, 1988. The Court
of Appeals entered an order dismissing CMA's petition on October
3, 1988.
Shell Chemical Co. v. EPA. 826 F.2d 295 (5th Cir. 1987)
On January 7, 1986, four manufacturers of mesityl oxide (MO)
and the Chemical Manufacturers Association filed in the Court of
Appeals a petition for judicial review of EPA's section 4 rule
requiring health effects testing of MO. The proceeding was held
in abeyance pending EPA's consideration of the manufacturers'
petition under section 21 of TSCA to withdraw the test rule. EPA
denied the petition on August 21, 1986 (51 F.R. 30216).
The manufacturers reinstituted the lawsuit and also filed an
action in District Court, on September 26, 1986, challenging the
denial of their section 21 petition. The District Court stayed
the case pending the outcome of the reinstituted lawsuit in the
Court of Appeals.
In August 1987, the Court of Appeals remanded the case "for
EPA to make supplemental findings in the administrative record
concerning the changes in MO use that have occurred since the
testing rule was promulgated and, if determinable, that will
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occur in the foreseeable future." (826 F.2d 298) The court stayed
implementation of the rule pending EPA's updated factfinding.
Since the rule is being reconsidered, the District Court
litigation was dismissed without prejudice to refiling another
citizens' petition should a subsequent rule be issued.
Synthetic Organic Chemical Manufacturers Association (SOCMA) &
Texaco Chemical Co. v. EPAf (No. 87-3265, 3d Cir.)
SOCMA and Texaco filed a petition for review of EPA's
February 1987 rule requiring a test known as the mouse visible
specific locus assay for the chemical, diethylenetriamine (DETA).
This assay is used to evaluate the potential for chemicals to
cause heritable gene mutations. Under the rule this assay would
have been required if certain initial tests showed a potential
for adverse effects. In the fall of 1988, EPA reviewed the
initial tests conducted on DETA and concluded that the mouse
visible specific locus assay was not necessary. The parties,
consequently, filed a joint motion to dismiss the case, which was
granted by the court in October 1988.
Ausimont U.S.A.. Inc-- et al. v. EPA. 838 F.2d 93 (3d Cir. 1988)
On February 1, 1988, the U.S. Court of Appeals for the Third
Circuit upheld EPA's test rule for four fluoroalkenes. The court
found that Congress granted EPA broad discretion in determining
when data must be produced. According to the court section 4
"prevents a testing rule based on little more than scientific
curiosity, yet allows the Agency to act when an existing
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possibility of harm raises reasonable and legitimate cause for
concern."
The court found EPA's evidence sufficient to justify testing
based on Agency concerns about the lack of scientific
uncertainty. This evidence included published data showing one
chemical to be a carcinogen, petitioners' inability according to
the court to present a strong enough basis to fully discredit the
data, EPA's assessment of the harm of one substance based on
another of similar molecular structure ("structure-activity
relationship" — SAR), and worker exposure data that the court
was not prepared to say would reduce the element of risk to
insignificance. The court acknowledged that this level of
evidence supported testing but would not necessarily support
regulation.
Chemical Manufacturers Association v. EPA. 859 F.2d 977 (D.C.Cir.
1988)
On October 21, 1988, the United States Court of Appeals for
the District of Columbia Circuit upheld a section 4 rule which
required manufacturers to conduct health effects testing of the
chemical substance, 2-ethylhexanoic acid (EHA). The court held
that EPA could promulgate a test rule if it found "more than a .
theoretical" basis for suspecting that some amount of exposure
takes place and that the chemical is sufficiently toxic at that
level of exposure to present an "unreasonable risk of injury to
health." Evidence needed to support a test rule was contrasted
to the greater certainty needed for regulation. The court
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further held that the existence of human exposure can be based on
inferences drawn from the circumstances of chemical manufacture
and use, and that EPA need rebut industry evidence only if that
evidence succeeds in rendering the Agency«s view of exposure
theoretical or speculative. According to the court, an isolated
or one time event could still warrant a test rule. Finally, the
court held that EPA correctly applied these standards and that
its findings were supported by the evidence, which the court
examined in considerable detail.
Chemical Manufacturers Association v. EPA. (No. 88-1352, D.C.
Cir.)
On February 26; 1988, EPA issued a testing rule for
diethylene glycol ether and its acetate (DGBE/DGBA). The rule
requires three tests to be conducted initially ("first tier"),
and would require a "second tier" developmental neurotoxicity
study if the results of the first tier tests are positive. CMA
wishes to challenge the requirement for the second tier study.
Since the first tier tests are not due until July 1989 and may
not trigger the second tier test, the parties requested and
received a stay of the litigation until September 1, 1989.
Chemical Manufacturers Association v. EPA. (No. 88-1637, D.C.
Cir.)
CMA filed a petition for review of a rule issued June 15,
1988, to require testing of approximately 30 chemicals identified
as hazardous waste constituents by the EPA Office of Solid Waste.
Prior to filing the suit CMA had petitioned EPA for an
administrative stay of the rule, arguing that the rule poses an
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unnecessary administrative burden on manufacturers who make small
quantities of the chemicals for research and development
purposes. EPA agrees with this critique. However, because this
criticism applies to all section 4 testing rules, EPA chose to
address CMA's concerns through a revised procedural rule and
decided that a stay of this particular rule would not be
appropriate. CMA and EPA, accordingly, have agreed to stay the
litigation on this rule pending the promulgation of the
procedural rule.
Chemical Manufacturers Association v. EPA. (No. 88-4710, 5th
Cir.)
On September 26, 1988, CMA and five manufacturers and
processors filed a petition for review of a section 4 rule
requiring testing of the chemical cumene. EPA issued this rule
under the authority of section 4(a)(l)(B), which authorizes the
Agency to require testing if it finds that a chemical is produced
in substantial quantities and that it is released into the
environment in substantial quantities or that there is or may be
substantial exposure to the chemical.
Along with its petition for review, CMA filed a motion for
stay of the rule arguing that, pending the decision on the
merits, the manufacturers would be irreparably harmed by being
forced into non-recoverable start-up costs for testing. CMA
argued that these costs would be unfair because CMA was likely to
succeed on the merits of the case.
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CMA supported its argument of likely success on the merits
by challenging EPA's interpretation of the section 4(a)(l)(B)
standard. EPA had justified testing based on a finding that
exposure to large numbers of persons constitutes substantial
exposure. CMA argues that the rule must also be supported by
evidence on the levels of exposure to those persons and that, in
any event, EPA's evidence does not show that large numbers of
persons will be exposed to the chemical.
Safe Buildings Alliance (SBA) v. EPAf 846 F.2d 79 (D.C. Cir.
1988)
The D.C. Court of Appeals upheld EPA's asbestos-in-schools
rules issued under the Asbestos Hazard Emergency Response Act
(AHERA) . The rules had been challenged by SBA — an association
of companies that formerly manufactured asbestos products. The
court extended substantial deference to EPA, holding that the
Agency's rules were reasonable in light of the somewhat
contradictory demands of AHERA, the uncertainties regarding the
health effects of low level asbestos exposure, and the tight
timetable AHERA imposed on EPA to issue regulations.
In August 1988, National Gypsum Company, one of the
petitioners before the Court of Appeals, filed a petition for
certiorari before the Supreme Court. The briefs on this petition
by both National Gypsum and EPA essentially repeated the
arguments made before the Court of Appeals.
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OTHER TSCA ACTIVITIES
State Programs
Section 28(c) of TSCA authorizes EPA to award grants to
states for programs to prevent or eliminate problems created
by toxic substances that EPA is unable or unlikely to act
upon under TSCA.
There were no grants administered under TSCA in Fiscal
Years 1987 and 1988. Grants associated with asbestos were
administered under the authority of the Asbestos School Hazard
Abatement Act.
Major Problems
No major problems in administering TSCA were encountered
in Fiscal Years 1987 and 1988.
Recommended Legislation
During 1987 and 1988 EPA did not determine that legislative
changes to TSCA were required.
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APPENDIX A
Major FY 1987 TSCA Actions
Description
Section
of Law
Date
4 (a)
4(b)
5*
5(a)(2)
For listing of testing decisions see Table 1.
Revision of TSCA Test Guidelines (Final Rule)
Test Guidelines Published
- Site-specific aquatic microcosm test
- Hydrolysis rate
- Generic freshwater microcosm test
- Soil core microcosm test
- Soil microbial community toxicity test
- Rhizobium/legume chronic toxicity test
Significant New Uses of Chemical Substances;
General Provisions for New Chemical Follow-up
(Proposed Rule)
Trichlorobutylene Oxide, Epibromohydrin, and
Hexafluoropropylene Oxide, Proposed Significant
New Use Rule (3 chemicals)
PBBs and Tris; Final Significant New Use Rule
(9 chemicals)
Ethanol, 2-amino-, compound with N-hydroxy-
N-nitrosobenzenamine (1:1) (P86-542)
Proposed Significant New Use Rule (1 chemical)
Methyl-n-butyl ketone; Final Significant New
Use Rule (1 chemical)
11-Aminoundecanoic Acid; Final Significant
New Use Rule (1 chemical)
l-Chloro-2-bromoethane; Proposed Significant New
Use Rule (1 chemical)
05/20/87
09/28/87
04/29/87
01/02/87
01/26/87
03/25/87
04/13/87
05/28/87
09/04/87
* Also under authority of TSCA sections 8 and 26(c)
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5(e) Consent Order; Acrylate modified alicyclic 10/06/86
urethane (P86-549)
Consent Order; Halogenated pyridine 10/06/86
derivative (P85-1184)
Consent Order; Amines, tri (Cll-14 ISO-C13 10/09/86
rich) (P85-265)
Consent Order with Testing Trigger; 10/10/86
Nonyltoluene (P86-78)
Consent Order; Substituted pyridine disazo 11/07/86
dye (P85-735)
Consent Order; t-Amyl peroxy mono carbonate 11/07/86
(P86-473)
Consent Order with Testing Trigger; 11/13/86
Perfluoroalkyl epoxide (P86-562)
Consent Order; Unsaturated dimer acids, 11/13/86
polyester, epoxidized (P86-628)
Consent Order with Testing Trigger; 11/13/86
Perfluoroalkyl epoxide (P86-872)
Consent Order with Testing Trigger; 11/13/86
Perfluoroalkyl epoxide (P86-873)
Consent Order With Testing Trigger; Vinyl 11/20/86
chloride-vinyl acetate hydroxyl modified
copolymer (P85-1388)
Consent Order with Testing Trigger; Dialkyl 12/03/86
substituted propionamide (P86-266)
Consent Order with Testing Trigger; Sodium, 12/09/86
pyridine, water (P86-1263)
Consent Order; Aromatic araino compound (P86-334) 12/10/86
Consent Order; Aromatic nitro compound (P86-335) 12/10/86
Consent Order; Substituted pyridine (P86-838) 01/03/87
Consent Order; Monosubstitutedalkoxyamino- 01/09/87
triazine (P86-1043)
Consent Order; Monosubstitutedalkoxyamino-
triazine (P86-1044)
01/09/87
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Consent Order; Acrylate ester (P86-924) 01/14/87
Consent Order; Substituted alkyl peroxy-2-ethyl 01/21/87
hexanoate (P86-1492) / /°
Consent Order; Substituted alkyl peroxyhexane 01/21/87
carboxylates (mixed isomers) (P86-1493)
Consent Order; 3-Hydroxy-l,i-dimethyl butyl 01/21/87
derivation (P86-1491)
Consent Order; Urethane acrylate with pendant 01/28/87
hydroxy and carboxyl groups (P86-1088)
Consent Order; Substituted nitrobenzoic acid, 01/28/87
derivative (P86-1098)
Consent Order with Testing-Trigger; Anionic 02/09/87
polymer (P86-1293)
Consent Order; Alkoxylated diol diacrylate 02/11/87
(P86-649)
Consent Order; Transition metal trichalcogenide 02/28/87
(P86-1021)
Consent Order; Aromatic methyl oxirane (P86-940) 03/23/87
Consent Order with Testing Trigger; Substituted 03/30/87
acetic acid, mixed sodium and potassium salts
(P86-530)
Consent Order with Testing Trigger; Substituted 03/30/87
acetic acid, potassium salt (P86-531)
Consent Order with Testing Trigger; Substituted 03/30/87
acetic acid, sodium salt (P86-532)
Consent Order; Alkyl substituted pyridine 04/03/87
(P86-831)
Consent Order; Benzotriazole derivative 04/03/87
(P86-1771)
Consent Order; Napthalene, 1,2,3,4- 04/15/87
tetrahydro(l-phenylethyl) (P85-1331)
Consent Order; Maleic acid half-ester 04/15/87
functionalized with alkenyl ether groups
(P86-1122)
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Consent Order; Capped aliphatic isocyanate 04/15/87
(P86-1146)
Consent Order; Aryloxy substituted alkyl 04/15/87
aryloxate (P86-1692)
Consent Order; Acrylylalkyl substituted 04/15/87
benzenepolyolcarboxylic acid derivative
(P86-1739)
Consent Order; Sulfite ester of 2,2'-methylene- 04/15/87
bis-(4-methyl-6-T-butylphenol), 2,2'-methylene-
bis-(4-methylphenol), toluene, tripropylamine,
methacrylic acid, dimethacrylic acid (P87-147)
Consent Order; 1,4-benzenedisulfonic acid, 2, 21- 05/11/87
[1, 2-ethenediylbis[3-sulfo-4, 1-phenylene)
imino[6-[(disubstituted)amino]-!,3,5-triazin-
4, 2-diyl]imino]Jbis-, hexasodium salt (P86-477)
Consent Order; 1,4-benzenedisulfonic acid, 2, 2'- 05/11/87
[1, 2-ethenediylbis[3-sulfo-4, 1-phenylene)
imino[6-[(disubstituted)amino]-1,3,5-triazin-
4, 2-diyl]imino]]bis-, hexasodium salt (P86-478)
Consent Order with Testing Trigger; Polyamine 05/15/87
adduct (P85-1239)
Consent Order with Testing Trigger; Polyamine 05/15/87
adduct (P85-1240)
Consent Order with Testing Trigger; Propoxylated 05/15/87
quaternary amine (P86-331)
Consent Order; Boron ester (P86-1252) 05/15/87
Consent Order; 2-Butenedioic acid (Z-), mono 05/22/87
2-(l-oxo-2-propenyl)oxy ethyl-ester (P85-543)
Consent Order; 2-propenoic acid, 2-methyl-, 05/22/87
7,7,9-triraethyl-4,13-dioxo-3,14-dioxa-5,
12-diaza hexadecane-l,16-diylester (P85-544)
Consent Order; 2-propenoic acid-3-(dimethylamino)- 05/22/87
2,2-dimethyl-propyl ester (P85-545)
Consent Order; 2-propenoic acid, 2-methyl-3,3,5- 05/22/87
trimethyl-cyclohexylester (P85-546)
Consent Order; 2-propenoic acid, 3,3,5- 05/22/87
trimethylcyclohexylester (P85-547)
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6(a)
6(e)
8 (a)
Consent Order with Testing Trigger; Aromatic 05/22/87
diamine, thio-methylated (P86-1322)
Consent Order with Testing Trigger; Halogenated 06/19/87
phosphate ester (P86-1662)
Consent Order; Fluoroalkyl epoxide (P86-1250) 06/23/87
Consent Order; Aryl azo thiophene (P87-304) 07/01/87
Consent Order; Propylene oxide, hydroxethyl 07/01/87
acrylate, monoethyl ether of hydroquinone, water
(P86-832)
Consent Order; Functional acrylate methacrylate 07/18/87
polymer (P86-1325)
Consent Order with Testing Trigger; alkanaminium, 08/14/87
polyalkyl-salt, polymer with acrylamide and
substituted alkyl methacrylate (P87-252)
Consent Order; Azlactone (P86-1634) 08/26/87
Consent Order; Phthalic acid polymer of 09/15/87
new substance (P86-1629)
Consent Order with Testing Trigger; Aliphatic 09/22/87
polyester (P87-10)
Consent Order; Styrenated hydroxyfunctional 09/23/87
methacrylic acrylic polymer (P87-739)
Procedures for Rulemaking Under Section 6 of 06/17/87
TSCA (Proposed Rule)
Asbestos Abatement Projects; Worker 02/25/87
Protection (Final Rule)
Polychlorinated Biphenyls Spill Cleanup 04/02/87
Policy (Final Rule)
Polychlorinated Biphenyls; Exclusions, Exemp- 07/08/87
tions and Use Authorization (Proposed Rule)
Polychlorinated Biphenyls in Electrical 08/21/87
Transformers (Proposed Rule)
Comprehensive Assessment Information Rule 10/07/86
(Proposed Rule) (47 chemicals)
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8(c)
8(d)
Preliminary Assessment Information Reporting; 11/14/86
Addition of 19th ITC List Chemicals (4 Chemicals)
(Final Rule)
Hexafluoropropylene Oxide; Submission of Notice 01/02/87
of Manufacture, Import or Processing (Proposed
Rule)
Addition of Chemicals to Information Rules; 05/14/87
Certain Pesticide Inert Ingredients (31
Chemicals) (Proposed Rule)
Chemical Information Rules; Addition of 05/14/87
Chemicals (24 chemicals) (Proposed Rule)
Preliminary Assessment Information and Health 05/20/87
and Safety Data Reporting; Addition of 20th ITC
List chemicals (4 chemicals) (Final Rule)
11-Aminoundecanoic Acid; Submission of Notice of 05/28/87
Manufacture, Import or Processing (Final Rule)
Anthraquinone; Final Reporting and Recordkeeping 06/04/87
Requirements (Final Rule)
Polyhalogenated Dibenzo-p-Dioxins/Dibenzofurans; 06/05/87
Reporting Requirements (Final Rule)
Polyhalogenated Diobenzo-p-Dioxins/Dibenzofurans; 06/05/87
Reporting Requirements (Final Rule)
Health and Safety Data Reporting; Addition of 11/14/86
19th ITC List Chemicals (4 Chemicals)
(Final Rule)
Health and Safety Data Reporting; Submission of • 05/01/87
Lists and Copies of Health and Safety Studies on
Certain Substances (102 chemicals) (Final Rule)
Addition of Chemicals to Information Rules; 05/14/87
Certain Pesticide Inert Ingredients (36
chemicals) (Proposed Rule)
Preliminary Assessment Information and Health 05/20/87
and Safety Data Reporting; Addition of 20th
ITC List Chemicals (4 chemicals) (Final Rule)
Polychlorinated Dibenzo-p-Dioxins/Dibenzofurans; 06/05/87
Reporting Requirements (Final Rule) -
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26(b) Proposed Fees for Processing Premanufacture 04/20/87
Notices, Exemption Applications and Notices, and
Significant New Use Notices (Proposed Rule)
CHEMICAL ADVISORY
2-Nitropropane 12/03/86
Toluenediamines (TDAs)
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APPENDIX B
Major FY 1988 TSCA Actions
Description
Section
of Law
Date
4(a)
For list of testing decisions see Table 2.
5(a)(2) Trichlorobutylene Oxide; Epibromohydrin; and 10/27/87
Hexafluoropropylene Oxide; Final Significant
New Use Rule (3 chemicals)
l-Chloro-2-bromoethane; Final Significant New 02/02/88
Use Rule (1 chemical)
Benzenamine, 4-chloro-2-methyl; Benzenamine, 09/16/88
4-chloro-2-methyl, hydrochloride; Benzenamine,
2-chloro-6-methyl; Proposed Significant New
Use Rule (3 chemicals)
1-Decanamine, N-decyl-N-methyl-N-oxide 12/08/87
(P86-566); Proposed Significant New Use Rule
(1 chemical)
Diphenyl-2,4,6-trimethylbenzoyl phosphine 02/02/88
oxide (P86-586); Proposed Significant New
Use Rule (1 chemical)
Significant New Use Rules; Amendments to 07/27/88
General Provisions; Final Rule
5(e) Consent Order; Saturated polyester (P86-1686). 10/09/87
Consent Order; Pseudomonas fluorescens 10/19/87
(P87-1292).
Consent Order with Testing Trigger; Substituted 10/30/87
1,6-dihydroxy napthalene (P87-1036).
Consent Order; Acrylated polyurethane (P87-760). 11/04/87
Consent Order with Testing Trigger; Acrylated 11/17/87
alkoxylated aliphatic polyol (P84-713)
Consent Order; Phthalic polyester (P87-262)
01/19/88
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Consent Order; Aliphatic polyester with
neopentyl glycol (P87-293)
Consent Order; Dialkenylamide (P87-502)
ofder; 19 C9 (OCH2 CH2)YOCH20CH2-OH
—J.489)
Consent Order; 2-Naphthalene carboxamide-N-
aryl-3-hydroxy-4-aryl azo (P87-1265)
Consent Order; Alkyloamide (P86-1315)
Consent Order; Alkylated aromatic diamine
(P85-929)
Consent Order; l-Oxa-4-azastiro[4.5]decane,
4-(dichloroacetyl)- (P86-1648)
Consent Order with Testing Trigger;
Tetraglycidylamine (P86-500)
Consent Order with Testing Trigger;
Tetraglycidylamine (P86-502)
Consent Order with Testing Trigger; Aromatic
diamine (P86-503)
Consent Order with Testing Trigger; Aromatic
diamine (P86-501)
Consent order; Genetically engineered strain
of Rhizobium Meliloti containing a recombinant
plasmid (P87-568)
Consent order; Genetically engineered strain of
Rhizobium Meliloti containing R. Meliloti NIF
genetic material carried on a plasid (P87-569)
Consent Order; Genetically engineered strain of
Rhizobium Meliloti containing R. Meliloti NIF
genetic material carried on a plasid (P87-570)
Consent Order with Testing Trigger; Methylene-
bis-trisubstituted aniline derivative (P87-90)
Consent Order; Poly(amino/hydroxyalkylaminomethyl)
urea (P87-1123)
Consent Order; Polyamine urea-formaldehyde
condensate (P87-1456)
01/19/88
01/19/88
02/01/88
02/01/88
02/02/88
02/19/88
02/24/88
03/02/88
03/02/88
03/02/88
03/02/88
03/09/88
03/09/88
03/09/88
04/25/88
05/04/88
05/04/88
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6(e)
8 (a)
Consent Order with Testing Trigger; Methylene- 05/06/88
bis(substituted) aniline derivative^(P87-790)
Consent Order with Testing Trigger; Cyclic - 05/12/88
halophosphite (P87-1657)
Consent Order; Nitroaromatic thiazoic and 05/12/88
derivative (P88-270)
Consent Order with Testing Trigger; 05/12/88
Substituted thioazino salt (P88-63)
Consent Order with Testing Trigger; 05/26/88
Tetrachloroethylene (solvent) (P88-217)
Consent Order; 2-hydroxyethyl methacrylate, 07/03/88
raaleic acid, maleic acid anhydride (P87-1159)
Consent Order; 4,4'methylene bis (oxethylene 07/14/88
diphenol, referred to as MOD (P87-1760)
Consent Order with Testing Trigger; metalated 08/01/88
alkylphenol copolymer (P87-723)
Consent Order; Aryloxalkyl halide (P87-1471) 09/13/88
Consent Order; Aminopolyamide - epichlorohydrin 09/20/88
resin (P84-1182)
Consent Order; Aminopolyamide - epichlorohydrin 09/20/88
polymer (P84-1183)
Prohibition of Hexavalent Chromium Chemicals 03/29/88
in Comfort Cooling Towers; Proposed Rule
Polychlorinated Biphenyls; Exclusions, 06/27/88
Exemptions and Use Authorizations; Final Rule
Polychlorinated Biphenyls in Electrical 07/19/88
Transformers; Final Rule
Polychlorinated Biphenyls; Manufacturing, 08/24/88
Processing, and Distribution in Commerce
Exemptions; Proposed Rule
Polychlorinated Biphenyls; Notification and 09/26/88
Manifesting for PCB Waste Activities; Proposed
Rule
Hexafluoropropylene Oxide; Submission of Notice 10/27/87
of Manufacture, Import or Processing; Final
Rule
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Preliminary Assessment Information Rule; 21st
ITC List; Final Rule (6 chemicals)
Preliminary Assessment Information Rule;
Addition of Chemicals; Final Rule (18 chemicals)
EDTMPA and its Salts; Submission of Notice of
Manufacture or Import; Proposed Rule
(14 chemicals)
Preliminary Assessment Information Rule; 22nd
ITC List; Final Rule (10 chemicals)
8(c) Chlorendic Acid/Anhydride; Request for Records
and Reports Regarding Significant Adverse
Reactions; Notice (2 chemicals)
Specified Members of the Categories Tri(Alkyl/
Alkoxy) Phosphates and Diisocyanates; Request for
Records and Reports Regarding Significant Adverse
Reactions; Notice (51 chemicals)
8(d) Health and Safety Data Reporting; 21st ITC
List; Final Rule (6 chemicals)
Health and Safety Data Reporting; 22nd ITC
List; Final Rule (8 chemicals)
Health and Safety Data Reporting; Period
Terminations; Final Rule (37 chemicals and
5 chemical categories)
21 PCBs: Denial of Citizen's Petitions; Final
Rule
26 (b) Fees for Processing Premanufacture Notices;
Exemption Applications and Notices, and
Significant New Use Notices; Final Rule
203 Asbestos-Containing Materials in Schools,
Final Rule
11/20/87
03/31/88
04/29/88
05/20/88
12/21/87
01/19/88
11/20/87
05/20/88
09/30/88
07/02/87
08/17/88
10/30/87
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