United States
Environmental Protection
Agency
Washington, DC
20460
January 1983
Toxic Substances
Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1982
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Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1982
U.S. Environmental Protection Agency
Office of Toxic Substances
401 M Street, S.W.
Washington, p.C. 20460
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TSCA Annual Report for FY82
Contents
I. Introduction
Highlights of the Year
• Program Implementation
• Regulatory Reform
• Enforcement
• International Cooperation
II. New Chemicals
Program Status
Exemptions
Follow-up
III. Existing Chemicals
Chemical Testing
• Program Status
• Information Reporting
• Test Guidelines
• Reimbursement
Small Business Initiatives
Existing Chemical Strategy
PCBs
Asbestos
Dioxins
Formaldehyde
CFCs
Page
3
IV. Enforcement
V. Litigation
VI. State Programs
Appendices
A. Summary/Guide to Information
Required by Congress
B. FY82 Chronology of Major
TSCA Regulatory Actions
Page
12
14
16
18
19
Tables
1. Summary of New Chemical Actions 5
2. EPA Responses to Interagency Testing 7
Committee Designations
3. Administrative Civil Actions Taken Under 13
§16 of TSCA
4. TSCA §28 17
NOTE: This Report to Congress summarizes progress made during Fiscal Year 1982 by the
Environmental Protection Agency (EPA) in implementing the Toxic Substances
Control Act (TSCA). It fulfills the congressional reporting requirements of the Act,
including those contained in Sections 30, 9(d), and 28(c) of TSCA and reports on
broader TSCA activities as well.
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I. Introduction
The Toxic Substances Control Act
(TSCA) took effect on January 1,
1977. It is a comprehensive piece of
environmental legislation designed to
fill gaps in protection among eighteen
other environmental and public health
laws. It is also a very complex piece of
legislation: it seeks to prevent injury
from harmful chemicals through a pro-
cess of premanufacture notification for
new chemicals (Section 5); to obtain
more data on potential chemical haz-
ards through authorities to require
testing (Section 4) and reporting (Sec-
tion 8); and to control unreasonable
risks of existing chemicals through
regulations (Sections 6 and 7). TSCA
authorizes EPA to regulate against
such risks at any stage in a chemical's
life-cycle: manufacturing, processing,
commercial distribution, use, and/or
disposal.
TSCA is wholly consistent with the
concept of controlling problems with
minimal burdens (Executive Order
12291, the Regulatory Flexibility Act,
and the Paperwork Reduction Act).
Specifically, TSCA mandates that its
authorities not impede or create un-
necessary economic barriers to tech-
nological innovation and that reason
and prudence be used in carrying out
its responsibilities. To achieve a
balanced approach, the Act requires a
weighing of risks against benefits pro-
vided by particular chemicals to the na-.
lion's economic and social well-being.
Highlights of the Year
Program Implementation. The
1982 fiscal year was a dynamic period
of TSCA implementation. The Agency
completed several key projects, some
of which have been in process for
some time. These include major rule-
making actions on asbestos and PCBs;
issuance of key information gathering
rules to support chemical testing deci-
sions, publication of nearly 100 testing
guidelines, announcement of proposed
exemption rules for selected new
chemicals, and the completion of a
number of negotiated agreements for
chemical testing. Also during this
period, the TSCA Inventory of Chem-
icals in Commerce was updated to in-
clude a current total of over 58,000
chemicals.
The Agency established firm priorities:
first, to meet all statutory and court
deadlines, second, to clean up Agency
backlogs, and third, to reduce unnec-
essary regulatory burdens. In pursuing
these priorities, the TSCA program re-
flected the Agency's commitment to
high quality scientific analysis in carry-
ing out its responsibilities to protect
public health and the environment.
Regulatory Reform. A number of
regulatory reform initiatives were im-
plemented during FY'82. The changes
may be characterized in terms of
policy, regulatory, and administrative
objectives. Policy reforms emphasize
negotiated testing agreements
wherever appropriate, allow flexibility
to industry whenever possible, and en-
courage small business initiatives. The
regulatory changes are designed to
reduce unnecessary regulatory bur-
dens, to provide for exemptions to re-
quirements, and to focus controls and
investigations on the more significant
health and environmental problems.
Administrative changes were instituted
to meet legislative and judicial time
schedules, to be more timely in
responding to constituents, and to
reduce work backlogs. As a result of
these changes in FY'82, for the first
time since TSCA became effective, the
Agency met all statutory and court im-
posed deadlines for every section of
the law.
Enforcement. Over the last year,
three broad trends have developed in
the regulatory philosophy of the com-
pliance/enforcement program. They
are (1) decreased emphasis on "adver-
sarial enforcement" and more em-
phasis on technical assistance; (2)
vigorous enforcement of serious
violators; and (3) avoidance of un-
necessarily burdensome restrictions on
the regulated community.
TSCA compliance inspections and en-
forcement actions have flourished in
this atmosphere and continue to in-
crease. For example, in FY'82 com-
pliance inspections were increased by
just over 100 percent and administra-
tive enforcement actions were over 30
percent higher than in FY'81. In con-
trast to FY'81 when EPA referred no
potential criminal cases to the Depart-
ment of Justice for consideration, in
FY'82 EPA referred two cases. In addi-
tion, in September 1982 the Agency
settled a major administrative civil
penalty case under TSCA. American
Cyanamid agreed to pay $18,750 in
settlement of a complaint alledging
violation of TSCA Section 8(e) by
delaying submission to EPA of infor-
mation indicating that a flame retar-
dant chemical could pose substantial
risks.
International Cooperation. Inter-
national cooperation in chemical con-
trol activities is intended to promote
the sharing of information among na-
tions. This is needed to reduce duplica-
tion of effort in chemical testing and
assessment, to provide better solutions
to global environmental problems, and
to avoid the creation of technical bar-
riers to trade. During FY'82, in con-
junction with its own responsibilities ,
related to chemical testing and assess-
ment, EPA continued to be actively in-
volved in related work with many inter-
national organizations. In addition,
EPA has made considerable progress in
implementing the Mutual Acceptance
of Data Decision in the U.S.
For example, the Agency participated
in the work of the multi-national
Chemicals Program of the Organization
for Economic Cooperation and De-
velopment (OECD). EPA provided ex-
perts to work groups responsible for
developing further OECD test guide-
lines, for updating previously adopted
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II. New
Chemicals
guidelines, and for work under the
Hazard Assessment Project. EPA was
designated to head the U.S. delegation
to the second High Level Meeting of
the Chemicals Group. At this meeting,
the Environmental Ministers of OECD
nations will take action on and provide
guidance for future work on implemen-
tation of OECD Principles of Good
Laboratory Practice, information ex-
change between member nations, trial
use of Data Interpretation Guides, and
a recently begun OECD Existing
Chemicals program.
EPA also participated extensively in the
work of the United Nations Environ-
ment Program (UNEP) and the World
Health Organization (WHO). The
Agency provided experts to assist the
UNEP/WHO International Program on
Chemical Safety in their work on har-
monizing risk assessment method-
ologies and to assist the Global En-
vironmental Monitoring System
(GEMS) activities in exposure assess-
ment projects around the world. EPA
serves as the U.S. focal point for the
UNEP International Register of Poten-
tially Toxic Chemicals (IRPTC). In that
capacity, the Agency distributes the
IRPTC Bulletin within the U.S. and
responds to international requests for
information on specific chemicals.
EPA also is an active participant in
current UNEP efforts to develop an in-
ternational framework convention for
protecting stratospheric ozone. This
activity is covered both by TSCA and
the Clean Air Act.
EPA prepared for its annual bilateral
consultation with the Commission of
the European Communities in October
of 1982. Agenda items for this meeting
include issues of mutual concern in the
areas of new and existing chemicals
under TSCA and the Sixth Amend-
ment of the European Economic Com-
munity's Directive in Classification,
Packaging, and Labelling of Dangerous
Substances.
Also in FY'82, EPA took further steps
to implement its responsibilities under
the Multi-lateral Trade Negotiation
Agreement on Technical Barriers to
Trade, as incorporated in the 1979
U.S. Trade Agreements Act. EPA is
required to provide adequate periods
for international comment on trade-
sensitive regulations, to honor the
U.S. commitment to "transparency" in
-decision-making, and to avoid any ac-
tivities which may create technical bar-
riers to trade. EPA has reviewed its
procedures for developing standards
which may be subject to the Trade
Agreements Act, and is satisfied that
all activities under TSCA are in full
compliance.
Program Status
Congress instructed EPA, in Section 5
of TSCA, to review new chemicals.
Manufacturers must notify the Agency
at least ninety days before they begin
manufacturing a new chemical. This
notification is called a premanufacture
notification or PMN. Since July 1979,
EPA has reviewed more than 1,700
new chemicals with the rate of submis-
sion increasing dramatically each year.
In FY'82 alone, 839 were received —
nearly one half the cumulative total
received to date.
Section 5(e) of TSCA authorizes EPA
to regulate a new chemical, pending
the development of information that is
needed to make a reasoned evaluation
of its health and environmental effects.
Such an action is taken if a chemical
presents unreasonable risks or is
manufactured in substantial quantities
and results in substantial environmental
release or human exposure. Section
5(f) authorizes EPA to issue rules, or
orders, controlling the manufacture,
processing, or distribution of individual
new chemicals in commerce that pre-
sent unreasonable risks. During the
1982 fiscal year, five new chemicals
were subject to the development of
either a 5(e) or a 5(f) order. In one
case, a company entered into a Con-
sent Order with EPA agreeing not to
manufacture the two new chemicals
until certain data was developed. In
the remaining cases, the companies
withdrew their PMN manufacturing
proposals.
Informal negotiations with companies
submitting PMNs to obtain their agree-
ment to undertake testing of chemicals
or otherwise voluntarily control ex-
pected risks have been highly success-
ful. In instances where EPA has iden-
tified specific concerns —particularly
about detailed circumstances of ex-
posure or use —manufactures have, for
the most part, been willing to provide
additional information. In addition,
companies have often taken steps at
the Agency's request to develop fur-
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ther data or to institute exposure con-
trols. During FY'82, this approach
resulted in twenty-nine cases of volun-
tary actions. (See Table 1.)
During the early half of the fiscal year,
an intensive review of the new
chemical program was undertaken by
senior program management. This
study led to a change in the thrust of
the program. Experience showed that
greater emphasis could be placed on
exemptions coupled with strong so-
called follow-up activities. For this
reason, the program is moving to
develop a more comprehensive new
chemicals program, reducing the
notice burden on new chemicals of low
concern (exemptions) and more effec-
tively encouraging the development of
health and environmental effects data
on other chemicals as their uses and
exposure expand (follow-up). These
two elements of the comprehensive
new chemicals program are described
below.
Table 1
Summary of New Chemical Actions
October 1, 1981 - September 30, 1982
Actions
Valid PMNs Received
Notice of Commencement of Manufacture
Voluntary Testing in Response to EPA Concerns
Voluntary Control Actions by Submitters
PMNs Suspended in Response to EPA Concerns
PMNs Withdrawn
Section 5(e) Orders Issued
Section 5(f) Order Initiated
No. PMNs
in FY'82
839
92
5
15
9
3
4
1
Aggregate Total
Since Beginning
(mid-1979)
1,711
536
15
30
14
15
11
1
Exemptions
The first element of the PMN program
is an effective exemption program.
Section 5(h)(4) of TSCA authorizes
EPA to exempt new chemicals from
premanufacture review, if the Agency
finds that they will not present an
unreasonable risk. Such a finding then
allows EPA to concentrate its re-
sources on those new chemicals the
Agency considers to have a potential
for unreasonable risk. This exemption
policy also encourages chemical in-
novation in low-risk chemicals; allows
the more rapid introduction of new
low-risk chemicals into manufacture
after EPA review is completed where
no concerns are raised; and reduces
regulatory burdens on manufacturers
of new chemicals without reducing
protection to public health or the
environment.
This exemption policy was begun in
FY'82 with a final rule for some instant
photographic chemicals. This rule,
published on June 4, 1982, exempted
manufacturers of certain chemicals
used in instant photographic and peel-
apart film articles. The rule establishes
workplace exposure limits and control
guidelines.
Although the Agency began its exemp-
tion program with a narrow class of
chemicals, it is directing its efforts
toward identifying broader classes of
iOw-risk chemicals. Exemption pro-
posals for certain site-limited in-
termediate chemicals, low-volume
chemicals, and polymers were publisrr-
ed for public comment on August 4,
1982. These categories were identified
as being of low risk concern after over
two years of experience reviewing
more than 1,700 PMNs. Under the pro-
posal, most of the chemicals in these
categories would undergo an ab-
breviated Agency review.
The exemption for site-limited in-
termediate and low-volume chemicals
would apply to (1) chemical in-
termediates—chemicals used in the
production of other chemicals —that
are used only at the site of manufac-
ture, and (2) chemicals manufactured
at volumes of 10,000 kilograms (22,000
pounds) or less per year. Under the
proposal, manufacturers would submit
an informational notice for EPA review
14 days before manufacture of an ex-
empt chemical. During these 14 days,
EPA would review the notice to ensure
that all of the requirements of the ex-
emption are met. Chemicals known to
be, or reasonably suspected of being,
carcinogens or teratogens would be
automatically excluded from the ex-
emption; also excluded would be
chemicals that might cause other
adverse human or environmental ef-
fects under anticipated conditions of
exposure. In addition, the proposal
would require manufacturers to have a
qualified expert assess the risks of the
chemical and conclude that it would
meet the conditions of the exemption
before the exemption would be
granted.
This proposal also would allow an ex-
emption for chemicals produced at
1,000 kilograms (2,200 pounds) per
year or less without review by a
qualified expert and without any
automatic exclusions. EPA would con-
tinue to have a 14-day review and
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. Existing
Chemicals
would prohibit chemicals from
manufacture under the exemption if
the review indicated that they had
potential for adverse human or en-
vironmental effects.
Under the proposal, manufacturers of
polymers that the Agency has iden-
tified as posing an especially low
hazard would only be required to
notify EPA when manufacture began.
As a class, polymers are substances
that, because of inherent chemical pro-
perties, are not likely to be absorbed
into living tissue or to be biologically
active. Manufacturers of other poten-
tially exempt polymers not identified by
EPA as a low hazard would be required
to submit a brief notice to EPA 14 days
before manufacture. EPA would have
the authority to require health and en-
vironmental effects data on these
polymers or otherwise to require the
submission of regular PMNs if it found
that they might present an
unreasonable risk.
Follow-up
The second element complement-
ing the PMN review program is an ef-
fective strategy to monitor new
chemicals that might be of concern as
their uses change or volumes increase.
EPA proposes to employ —whenever
necessary —any one of several strong
follow-up tools to re-review any new
chemicals that may cause unreason-
able risks in the future if manufac-
tured, processed, distributed or used
outside of the original conditions of
review.
During FY'82, the Agency made pro-
gress in developing significant new use
rules (SNURs) under Section 5 and
reporting requirements under Section 8
for follow-up. SNURs can be used at
the end of the ninety-day premanufac-
ture review period. They require in
specific cases, that the manufacturer
notify EPA before a chemical is pro-
duced for a significant new use. Sec-
tion 8(a) of TSCA could be used at
any time, on any chemical, to require
manufacturers, processors, and im-
porters of that chemical to submit pro-
duction, use and exposure data. This
information, when combined with
Agency projections, will allow the EPA
to decide whether a chemical should
be considered for any type of voluntary
or mandatory control action or whether
additional chemical testing is
necessary.
A third follow-up tool was identified
and will be considered for use in
specific situations. EPA may, begin-
ning at the end of the ninety-day
premanufacture review period, require
that when commercialization reaches a
certain point, manufacturers must sub-
mit additional test data. This is a
"delayed trigger" for a TSCA Section
5(e) action.
Chemical Testing
EPA's chemical testing program is one
of the focal points for the development
and accumulation of test data under
TSCA. Test data retrieved under the
authority of TSCA Section 4 will nar-
row the gap of scientific knowledge for
other regulatory agencies as well as for
the EPA. Section 4 of TSCA gives
EPA the authority to require manufac-
turers and processors of a designated
chemical to test for certain adverse
health or environmental effects. Sec-
tion 4 also established an Interagency
Testing Committee (ITC) which desig-
nates chemicals for priority testing
consideration. The ITC's list of desig-
nations is limited to 50 chemicals at
any one time, although additional
chemicals may be added as EPA re-
sponds to previous designations. The
Committee under the Act must con-
sider revising its list every six months.
EPA must respond within one year to
each designation by initiating rulemak-
ing to require testing or giving reasons
for not doing so.
Program Status. The EPA was
sued in 1979 for failure to respond to
ITC designations within the statutory
deadline of one year. The result of the
suit was a court order putting EPA on
a three-year schedule to respond to the
backlog of chemicals from ITC lists 1
through 6. By the end of FY'82, the
Agency had met the first year of the
court schedule and reduced this back-
log from 37 to 26 chemicals. At the
same time, EPA executed its statutory
responsibilities of responding within
one year for new designations on ITC
lists 7 and 8.
During this fiscal year, EPA imple-
mented the concept of negotiating
testing agreements with industry as an
alternative to rulemaking in appropriate
cases. In order to be acceptable, the
industry generally must agree, prior to
EPA's statutory or court-ordered dead-
lines, to perform the testing recom-
mended by the ITC to the extent EPA
has determined that the testing is ap-
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propriate under the criteria of §4 of
TSCA. The negotiated agreement in-
cludes a description of testing to be
performed, preferred test protocols,
and a schedule for completion. The
negotiation process also always pro-
vides opportunities for public comment
on the agreement and on the testing
program.
The greatest benefit of the negotiated
testing agreement approach is the po-
tential for getting testing under way far
more quickly than through the time-
consuming rulemaking process, which
involves proposal, public comment,
possible reproposal, and final rule. The
negotiated testing approach can lead
to initiation of testing within one-and-
one-half years after ITC designation,
whereas rulemaking will average from
two-and-one-half to three years after
ITC designation. EPA has already re-
ceived some test data from testing
agreements negotiated in January and
April 1982 for chlorinated paraffins and
for 2-chlorotoluene, respectively. The
speed-up of testing and the reduced
adversarial relationship are other impor-
tant public benefits. The Agency still
retains its rulemaking perogatives,
should they be needed.
In FY 1982, EPA negotiated four test-
ing agreements, issued seven decisions
not to test (seven chemical substances
or categories), published one proposed
rule and two advanced notices of pro-
posed rulemaking. (See Table 2.)
Information Reporting. To-en-
hance the Agency's ability to make a
decision concerning the need for chem-
ical testing or control activities, EPA
issued two final rules to gather much
needed information from industry.
On June 22, 1982, EPA published a
final TSCA Section 8(a) Preliminary
Assessment Reporting Rule. This rule
requires manufacturers to report pro-
duction, use, and exposure data,
which are crucially important to the
Table 2
Responses to Interagency Testing Committee (ITC) Designations
Date
10/30/81
10/30/81
10/30/81
11/2/81
11/2/81
11/5/81
1 /8/82
1/8/82
4/28/82
4/29/82
4/28/82
Chemical /Category
Fluoroalkenes
Alkyl Phthalates
Benzyl Butyl
Phthalates
Butyl Glycolyl Butyl
Phthalates
Polychlorinated ,
terphenyls
Chlorinated
naphthalenes
Benzidine-based dyes;
o-Tolidine dyes;
o-Dianisidine dyes
Chlorinated Paraffins
Phenylenediamines
2-Chlorotoluene
Diethylenenetriamine
(DETA)
Hexachloroethane
(HCE)
Action
Advanced notice of proposed
rulemaking: testing requirements
Test agreement negotiated with
industry; preliminary decision not to
require testing (final decision 1 75/82)
Test agreement negotiated with
industry; preliminary decision not to
require testing (final decision 1/5/82)
Decision not to test: non-TSCA
jurisdiction; FDA responsibility under
FDCA
Decision not to test: all production and
importation has ceased; no exposure
Decision not to test: U.S. production
has ceased, only minor importation;
extremely limited exposure
Decision not to test: ongoing
extensive government and industry
testing
Test agreement negotiated with
industry; decision not to require testing
Advance notice of proposed rulemaking:
testing requirements
Test agreement negotiated with
industry; decision not to require testing
Proposed testing requirements
Decision not to test: environmental
effects testing not needed due to small
quantities released
ITC
List
7
1
7
7
2
2
5
5
5
1
6
8
8
8
Agency's activity concerning the ITC-
designations as well as other chem-
icals. These data will aid the Agency in
deciding whether testing is necessary.
When combined with the results of
testing, these data also will allow the
Agency to link chemical-specific hazard
and exposure information in making
any future control decisions. In ad-
dition to the ITC chemicals, the list of
250 chemicals subject to the above
final Preliminary Assessment Reporting
Rule contains certain chemicals
brought to the Agency's attention
under Section 8(e) of TSCA.
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The final 8(a) rule was accompanied by
three proposed amendments. The first
would allow-the Agency to require
supplemental information from
companies that further process these
manufactured products. This additional
information would be requested if EPA
received insufficient information from
the original manufacturers' reports.
Another proposed amendment would
add about 50 chemicals to the rule.
These chemicals were designated by
the ITC after the final rule had been
proposed. The third amendment would
provide for automatic reporting of
information following future ITC
designations.
The second final reporting rule, under
Section 8
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scheduled evaluation process, to focus
resources first on chemicals of major
concern, to take action quickly, and to
avoid long lists of chemicals awaiting
disposition.
As with other TSCA activities, ne-
gotiated solutions to resolve problems
with existing chemicals will be pursued
if appropriate. However, TSCA Section
6 rules will be promulgated as needed
to reduce unreasonable risks. Risk
identification activities will first deal
with problems identified through statu-
tory mechanisms, such as substantial
risk notices (Section 8(e)) and require-
ments to regulate PCBs (Section 6(e)),
citizen petitions (Section 21), and data
developed from test rules or negotiated
agreements (Section 4).
Illustrative of the success potential of
nonregulatory approaches to control-
ling risks has been the use of the "sub-
stantial risk" information reporting pro-
vision, Section 8(e) of TSCA. Under
this provision, chemical manufacturers,
processors, and distributors are re-
quired immediately to notify EPA when
they obtain any new information that
reasonably supports a conclusion that
a chemical poses a substantial risk of
injury to health or the environment. In
FY'82, EPA evaluated 45 such notices
of substantial risk.
The Agency also receives notices sub-
mitted on a "For Your Information
(FYI)" basis from those who have risk-
related information that does not fit
Section 8(e) criteria, but feel that it
needs to be brought to the Agency's
attention. Such FYI submissions to-
taled 76 in FY'82.
With on-going and specific Agency en-
couragement and through informal ne-
gotiations, more and more companies
are voluntarily controlling uses of and
limiting exposures to toxic chemicals in
a variety of ways. Actions which range
from worker notification, to pro-
cess/handling changes, to discontinu-
ing production have been brought to
EPA's attention by both TSCA Section
8(e) and FYI submissions.
Polychlorinated
Biphenyls (PCBs)
Section 6(e) of TSCA generally bans
the manufacture (including importa-
tion), processing, distribution in com-
merce, and use of PCBs. Section 6(e)
also requires EPA to issue regulations
regarding disposal and labeling of
materials containing PCBs. Accord-
ingly, in February 1978, EPA issued a
rule regulating the disposal and mark-
ing of PCBs. This rule required the
marking of many PCB items still in ser-
vice and set up a system for the proper
disposal of PCBs. On May 31, 1979,
EPA issued a PCB Rule that mitigated
the total ban on the manufacture, pro-
cessing, distribution in commerce, and
use of PCBs, by allowing certain
exceptions.
Shortly after this PCB Ban Rule was
issued, the Environmental Defense
Fund (EOF) challenged the rule's va-
lidity before the U.S. Court of Appeals
for the District of Columbia Circuit.
EOF sought review of this rule on
three points: (1) EOF challenged the
determination by EPA that certain
commercial uses of PCBs are "totally
enclosed," and, therefore, exempt
from regulation under the Act; (2) EOF
claimed that EPA acted contrary to law
when it limited the applicability of the
statutory bans on manufacture, pro-
cessing, distribution in commerce, and
use of PCBs to materials containing
concentrations of PCBs greater than 50
ppm; and (3) EOF challenged the deci-
sion by EPA to authorize the continued
use of 11 non-totally enclosed uses of
PCBs.
On October 30, 1980, the Court ruled
in favor of EOF on the first two chal-
lenges. Subsequent negotiation by the
parties resulted in orders by the Court
allowing EPA time to publish revised
PCB regulations. These rules were to
address use of PCBs in electrical
equipment by August 19, 1982 and
manufacture, processing, distribution
and use of PCBs in closed manufactur-
ing processes and controlled waste-
manufacturing processes by October
13, 1982. In addition, by November 1,
1982, EPA was required to submit to
the Court a plan describing future
regulatory action on uncontrolled PCBs
processes.
The rule governing use of PCBs in
electrical equipment was signed by the
Administrator on August 18, 1982. This
rule allows the use of certain electrical
equipment containing PCBs to con-
tinue under specified conditions
because the Agency has concluded
that the uses will not present an un-
reasonable risk. The rule prohibits the
use of PCBs in transformers and elec-
tromagnets (with a PCB concentration
of 500 ppm or greater) posing an ex-
posure risk to food or feed after Oc-
tober 1, 1985; and the rule requires a
weekly inspection of this equipment for
leaks until that date. Other provisions
include:
• A requirement for a quarterly inspec-
tion of other PCB transformers (for
their remaining useful life);
• A requirement to maintain records of
inspection/maintenance for at least 3
years after disposing of PCB
transformers;
• An authorization for the use of large
PCB capacitors that are located in
contained and restricted access in-
stallations or restricted access elec-
trical substations for the remainder of
their useful lives; and
• A prohibition on the use of all other
large PCB capacitors after October 1,
1988.
On October 12, 1982, the Administra-
tor signed a second rule. This regula-
tion excludes from the 1979 ban two
types of processes that manufacture
PCBs as by-products or impurities.
First, PCBs released from the pro-
cesses into the air, water, or waste
products are excluded if they do not
exceed limits stated in the rule. These
limits represent the lowest levels able
-------
to be practically quantified. Other pro-
cesses may be excluded from the
statutory ban if the wastes exceed the
limits, provided such wastes are
disposed of in an EPA-approved man-
ner, and as long as PCBs released into
the air, water, and products are below
the limits stated in the rule.
Asbestos
During the 1982 fiscal year, EPA
brought several asbestos activities to
fruition. Two rulemaking actions were
completed, and steps were taken to
better coordinate the Federal govern-
ment's asbestos investigations and
regulatory programs.
One important rulemaking action was
to inform the nation's school popula-
tion of the presence of any friable
(crumbling) asbestos-containing
materials. On May 27, 1982, EPA
published the final "Asbestos-in-
Schools" rule, which requires public
and private elementary and secondary
schools to identify friable asbestos-
containing building materials, to main-
tain records of their analysis and the
location of friable materials, and to
notify school employees and parents
when friable asbestos is found.
This rule is complemented by EPA's
Technical Assistance Program (TAP).
The TAP, available through the EPA
Regional offices, provides guidance to
aid schools in investigating the
presence of asbestos in their buildings,
and in determining whether abatement
actions are necessary.
One of the primary obstacles to addi-
tional asbestos investigations is the
lack of needed exposure and produc-
tion data. To this end a second major
asbestos rulemaking was published on
July 30, 1982, under Section 8(a) of
TSCA. The rule requires that asbestos
producers, importers, and processors
report certain information about their
industrial and commercial activities.
Specifically, this reporting will include
the following information: identification
of producers, importers, and pro-
cessors and their asbestos-containing
products; amounts mined, consumed,
and imported; summaries of monitor-
ing data in the workplace; identifica-
tion of plant sites and estimates of site
emissions; and amounts of wastes
generated and methods of disposal.
The regulation requires information to
be submitted to EPA in two phases
beginning October 30, 1982. The infor-
mation gathered will provide a current
data base to identify unreasonable risks
from asbestos exposure and for de-
veloping initiatives to protect public
health. The rule will support investiga-
tions by the EPA and other Federal
agencies.
In mid-1982, EPA initiated the forma-
tion of both a Federal Asbestos Task
Force* and an EPA Asbestos Task
Group to work toward developing a
unified Federal approach to asbestos
regulation and to coordinate the future
actions of participating Federal agen-
cies. This coordinated approach dem-
onstrates the Agency's commitment to
the dual objectives of protecting the
public with cost-effective, non-
duplicative, and consistent programs.
Dioxins
TCDD (2,3,7,8-tetrachlorodibenzo-p-
dioxin) is an undesirable contaminant
formed during the manufacture of cer-
tain substances. TCDD, commonly re-
ferred to as dioxin, is highly toxic and
is found to be carcinogenic in
laboratory animals; it has other signifi-
cant adverse health effects as well.
•Consumer Product Safety Commission, Occupa-
tional Safety and Health Administration, and En-
vironmental Protection Agency with the National
Institute of Occupational Safety and Health,
Mine Safety and Health Administration, Food
and Drug Administration, National Institute of
Environmental Health Sciences, National Cancer
Institute serving as associate members.
On May 12, 1980, EPA promulgated a
rule under Section 6 of TSCA prohibit-
ing Vertac Chemical Company from
disposing of its wastes containing
TCDD stored at its Jacksonville, Ar-
kansas facility. The rule also requires
that any other persons planning to
dispose of TCDD-containing wastes
notify the Assistant Administrator for
the Office of Pesticides and Toxic
Substances 60 days prior to their in-
tended disposal.
The existing rule is and was intended
to be, a short-term solution to a long-
term problem. It also provided EPA
with the opportunity to review plans
by other companies to dispose of
TCDD-containing wastes and to stop
that disposal, if necessary.
In January 1982, EPA published in the
Federal Register an Advanced Notice
of Proposed Rulemaking (ANPR) to
announce its intent to review the di-
oxin rule. The ANPR also solicited a
proposal from Vertac about how to
dispose of its wastes and comments
from the general public about potential
methods for disposing of any TCDD-
contaminated wastes.
Two weeks after publishing the ANPR,
EPA, the State of Arkansas, and Ver-
tac entered into a Consent Decree that
controls the management of TCDD-
contaminated wastes and other site
conditions at the Vertac facility in
Jacksonville, Arkansas. This Consent
Decree requires a number of studies to
be conducted in order to determine ex-
isting conditions in and around
Vertac's facility. It also requires that
Vertac submit both an inventory of the
wastes stored on site and a proposal
for managing those wastes. The Con-
sent Decree requires that Vertac make
its "best efforts" to reduce the volume
of stored wastes and to report to EPA
every six months for five years about
its progress in reducing waste volume.
The Consent Decree specifies that any
applicable regulation promulgated by
various governmental authorities takes
precedence over the Decree.
10
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Formaldehyde
In December 1981, the Chemical In-
dustry Institute of Toxicology published
the final report of their 24-month in-
halation study in which rats exposed to
formaldehyde developed nasal cancer.
The preliminary results of this study,
coupled with formaldehyde's wide-
spread exposure, brought formalde-
hyde to the attention of EPA for inves-
tigation under TSCA. After review of
the available data, the Agency con-
cluded that formaldehyde is a car-
cinogen in the rat by the inhalation
route and possibly also in the mouse
by the same route. It is also presumed
that formaldehyde may, in theory,
pose a risk of cancer to humans.
However, analysis of exposure scen-
arios led to the conclusion that cancer
risks posed by formaldehyde exposures
under EPA's jurisdiction were low.
Because some potential health effects
of formaldehyde are still of concern,
EPA is working to identify needed in-
formation and achieve consensus for
filling any data gaps. On June 30,
1982, EPA signed an Interagency
Agreement with the National Center
for Toxicological Research, a Federal
facility co-funded by EPA and the
Food and Drug Administration, to (1)
establish expert review panels with
scientists from government, academia,
and industry that will consider data on
exposure, risk estimation, toxicology,
and epidemiology; (2) create an infor-
mation clearinghouse on existing and
new scientific data; and (3) hold a
scientific consensus workshop to agree
on future actions to improve data on
formaldehyde, and to publish peer
review workshop proceedings. EPA
believes that this action will bring con-
cerns over formaldehyde's health ef-
fects into better balance.
In addition under the TSCA program,
the Agency is funding a large-scale
epidemiology study designed to fill the
gaps that have been identified in the
existing epidemiology data base.
Chlorofluorocarbons
(CFCs)
/
Stratospheric pollution arising from
human activities may lead to a de-
crease in stratospheric ozone, which
could lead to an increase in ultraviolet
radiation from the sun at the earth's
surface. Pollutants thought to affect
the ozone (creating/destroying
.equilibrium) include: (1) Chlorofluoro-
carbons (CFCs) and certain other halo-
genated hydrocarbons (e.g., methyl
chloroform, carbon tetrachloride, etc.);
(2) nitrogen oxide emissions (NOX)
from sub- and supersonic aircraft; (3)
nitrous oxide (N?.0) from agricultural
practices and high-temperature com-
bustion; (4) carbon dioxide resulting
from the combustion of fossil fuels and
deforestation; and (5) methane (CH4>
released from the biosphere. Ozone
blocks a portion of the ultraviolet radia-
tion (UV-B) emitted from the sun. UV-
B is known to have certain deleterious
biological effects. However, the type
and magnitude of stratospheric modifi-
cation due to these pollutants remain
uncertain.
The United States has been partici-
pating in and supporting the interna-
tional activities related to the ozone
issue. For example, the United Nations
Environment Program (UNEP) activities
related to stratospheric ozone are in-
creasing. The U.S. is participating in
the drafting of the UNEP framework
convention to protect stratospheric
ozone. The convention, once com-
pleted, would formalize international
cooperation in the science, monitoring,
and exchange of information.
EPA is also pursuing additional
research on the depletion issue with
other Federal agencies, industry, and
academia. During FY'82, the Agency
initiated a number of activities under
TSCA to increase its information base
in this area. EPA is currently con-
tributing to the funding of further at-
mospheric modeling at the Lawrence
Livermore Laboratory at a total of
$300,000 over a three-year period. In
the spring of 1982, EPA signed an In-
teragency Agreement with the National
Oceanic and Atmospheric Administra-
tion (NOAA), with contributions from
the World Meteorological Organization
and industry, to establish six
automated land-based ozone monitor-
ing stations (Umkehr system)
throughout the world.
In addition to its domestic research
and international efforts, EPA is con-
tinuing to assess the need for further
regulatory initiatives as more data
become available and to "fine tune" its
1978 ban on nonessential uses of CFCs
as aerosol propellents. In FY'82, the
Agency responded to three petitions
seeking exemptions to this rulemaking,
citing essential uses. The first two
petitions, for which exemptions were
granted January 5, 1982, include the
use for pharmaceutical rotary tablet
press punch lubricants and use in
spinnerette release agents.
The former action was based on the
fact that there were no available alter-
natives and the fact that removal could
have had an adverse economic impact
and a potentially unfavorable health
impact on the public. The latter ex-
emption was granted on the basis that
substitutes are not available for all
uses.
A third petitioner, Virginia Chemicals,
Inc., was issued an immediately effec-
tive special exemption on June 1,
1982, permitting the limited use until
December 31, 1982, of CFCs in time-
released insecticide dispensing systems
used in treating long-term stored
tobacco. The exemption allows the use
during the 1982 tobacco infestation
season but denies use during all subse-
quent seasons.
11
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IV. Enforcement
Under Section 16 of TSCA, EPA may
levy either civil or criminal penalties for
a violation of several sections of the
Act. The Agency has developed
specific enforcement strategies for im-
plementing regulations under TSCA.
These strategies identify and rank
possible violations of a particular
regulation, identify the tools available
for compliance monitoring and how
they will be used, provide a formula for
determining the application of inspec-
tion resources, and establish a policy
for determining civil penalties under
the regulation.
Civil Enforcement Action. In FY
1982, all but one enforcement action
under Section 16 involved alleged vio-
lations of the PCB rules. The Agency
filed a total of 100 civil complaints dur-
ing the fiscal year as a result of the
PCB inspections; 93 cases were com-
pleted; and $475,850 in civil penalties
was assessed. Figures for each EPA
Region appear in Table 3.
The Agency assessed the largest single
penalty, $47,500, against the Electrical
Service Company (ESC) of Cincinnati,
Ohio. On August 10, 1982, Administra-
tive Law Judge Marvin E. Jones held
that ESC had violated the disposal,
marking, storage, and recordkeeping
requirements of the PCB regulations.
The Respondent is appealing the deci-
sion to the Administrator.
Criminal Enforcement Actions.
Criminal cases must be filed on EPA's
behalf in Federal court by the Depart-
ment of Justice. In FY 1982, two po-
tential criminal cases were referred to
the Department of Justice for con-
sideration. Also during the year, the
Fourth Circuit Court of Appeals upheld
the May 1981 conviction of Mr. Robert
E. Ward, of the Ward Transformer
Company, for aiding in the illegal
dumping of transformer oil con-
taminated with PCBs on roadsides in
North Carolina.
Compliance Actions. The EPA
took action to enforce compliance with
various TSCA requirements. The EPA,
along with five State agencies co-
operating under the terms of enforce-
ment grants-in-aid, conducted 2,089
PCB compliance monitoring inspec-
tions. Region II issued an ad-
ministrative civil complaint citing the
American Cyanamid Company with
violating the substantial risk reporting
requirements of TSCA Section 8(e).
The Respondent paid a civil penalty of
$18,750. The Agency conducted 43 in-
spections to monitor compliance with
the interagency ban on nonessential
aerosol uses of CFCs and conducted
32 inspections to determine compliance
with the dioxin rule under Section 6.
Also, in FY 1982, the Agency in-
spected 17 firms that failed to meet the
deadline for reporting identities of ex-
isting chemicals as required under Sec-
tion 8(b) of TSCA. The inspections
were conducted to ensure that
substances reported late to the Agency
were not, in fact, new chemicals sub-
ject to the PMN requirements of Sec-
tion 5. The Agency also conducted 33
inspections and compliance monitoring
reviews of facilities subject to Section
5 requirements.
Program Actions. During FY 1982,
EPA developed compliance strategies
for enforcing the Section 5(h)(4) in-
stant photographic materials exemp-
tion, the Section 6 Asbestos-in-
Schools Rule, the Section 6 PCB In-
terim Measures program, and the Sec-
tion 8(a) Level-A Reporting Rule; and
strengthened existing strategies for
Sections 4 and 5. In addition, EPA im-
plemented a cooperative program with
the Food and Drug Administration
(FDA) for the inspection of food and
feed facilities for PCBs.
Pilot cooperative enforcement agree-
ments with five States (California,
Connecticut, Maryland, Michigan, and
Ohio) continued in FY 1982. These
grants will provide dats for use by
other States in developing their own
toxic substances compliance programs.
The Agency began an evaluation of
the PCB compliance program in FY
1982. When the evaluation is com-
pleted, EPA will be able to revise the
current compliance strategy to better
target high-risk facilities to achieve
maximum environmental results.
The Agency also utilized negotiated
compliance agreements to bring a
number of firms into compliance with
TSCA rules.
12
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Table3
Administrative Civil Actions Taken Under Section 16 of TSCA for Violations of PCB Regulations
Complaints Issued, Cases Completed, and Amounts Assessed (by Region)*
Region
I
II
III
IV
V
VI
VII
VIII
IX
X
HQ
Total
Total No.
Complaints
Issued
FY 79-82
8
68
26
12
66
54
22
30
15
8
2
311
No.
Complaints
Issued in
FY'82
1
16
15
3
25
14
6
13
4
2
1
100
Total
No. Cases
Completed
FY 79-82
7
46
17
3
36
40
14
24
10
5
1
203
No. Cases
Completed**
in
FY '82
1
17
9
0
23
15
6
12
4
5
1
93
Total
No. of
Cases
Pending
1
22
9
9
3fl
13
8
6
5
3
1
108
Total Civil
Penalty Amount
Assessed (in $)
in FY '82
0
92,550
35,075
0
176,100
39,200
23,150
65,200
30,375
14,200
0
475,850
Total Civil
Penalty Amount
Assessed (in $)
in FY 79-82
30,100
479,300
81,775
23,525
278,920
142,460
49,300
163,300
56,675
14,200
0
1,319,555
*AII actions taken involved alleged violations of Section 6 PCB rules.
"Includes cases carried over from FY '80-FY '81.
13
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V. Litigation
Environmental Defense Fund, Inc. v.
Environmental Protection Agency (No.
79-1580, D.C. Cir.). In 1979 the En-
vironmental Defense Fund (EOF) peti-
tioned for review of EPA's regulations
under TSCA Section 6(e)(2) and (3)
governing the manufacture, process-
ing, distribution, and use of poly-
chlorinated biphenyls (PCBs). A deci-
sion largely in EDF's favor was issued
on October 30, 1980. This decision,
and its aftermath, were reported in
TSCA annual reports for 1980 and
1981. Developments in this case for
1982 are as follows:
In March 1982, EPA advised the Court
of its plans for further action with
rspect to the regulation of other PCBs
in low concentrations and submitted to
the Court a motion to extend the stay
of the mandate for such low concen-
tration PCBs until December 1, 1982.
EPA reasoned that it had to determine
which processes were to be regulated
under the October 1982 rule before fur-
ther action could be planned. The
Court granted EPA's request in an
April 9, 1982, order. The order required
EPA to submit a plan of action to the
Court by November 1, 1982.
On August 18, 1982, EPA promulgated
a final rule on the use of PCBs in elec-
trical equipment. Petitions for review
of that rule have been filed by several
parties in the U.S. Court of Appeals
for the District of Columbia Circuit and
the U.S. Court of Appeals for the
Fourth Circuit:
Natural Resources Defense
Council, Inc. and Environmental
Defense Fund, v. EPA (D.C.
Cir., No. 82-2045)
American Frozen Food Institute,
Inc. v. EPA (4th Cir., No.
82-1790)
The National Electrical Manufac-
turers Association v. EPA (D.C.
Cir., No. 82-2166)
The Edison Electric Institute,
The National Rural Electric
Cooperative Association, et al.,
v. EPA (D.C. Cir., No. 82-2198)
EDF also amended its petition for
review in the original PCB case.
It is anticipated that all dockets will be
consolidated for hearing before one
court. Arguments will be filed during
FY'83.
In a manner related to the original PCB
litigation, the Court Awarded EDF ap-
proximately $100,000 in attorney fees
under Section 19(d) of TSCA. This
was reduced from EDF's original re-
quest of approximately $170,000.
EDF's claim was based on time ex-
pended by its attorneys in prosecuting
EDF v. EPA, adjusted upward by a fac-
tor of 2, under applicable case law, to
reflect the quality of representation and
the contingent nature of success in the
litigation. The Court rejected EDF's up-
ward adjustment but awarded an
amount equal to almost the entire
amount of attorney fees requested plus
an upward adjustment of 17 percent to
reflect public benefit resulting from the
litigation and delay in receipt of
payments. The Court rejected EPA's
arguments that EDF was not entitled
to an award for:
(1) work performed on issues upon
which EDF did not prevail;
(2) work performed on issues raised
by industry intervenors; and
(3) work performed in connection
with post-decision negotiations.
EPA's petition for rehearing on
whether EDF was entitled to an award
on issues upon which it did not prevail
is still pending.
Warren County v. North Carolina (No.
79-560-CIV-5) and Twitty v. North
Carolina (No. 80-41-CIV-5) (E.D.N.C.)
These actions were brought by Warren
County and private parties against the
State of North Carolina and EPA to
prevent a tract of land in Warren
County from being used as a landfill
for the disposal of soil contaminated
with polychlorinated biphenyls (PCBs).
Plaintiffs had challenged EPA actions
on three grounds:
(1) The Region IV Administrator's
action in preliminarily approving
the landfill site was improper
under the Toxic Substances
Control Act (TSCA) and ap-
plicable regulations;
(2) EPA failed to prepare an En-
vironmental Impact Statement
(EIS); and
(3) The landfill would violate a
County ordinance prohibiting
disposal of PCBs.
On November 27, 1981, the Court
decided against the plaintifs on all
counts. It deferred to Agency expertise
in the highly technical area of PCB
landfill approval. In dismissing the
charge that EPA failed to file an EIS,
the Court cited the long string of cases
holding that EPA is not required under
its other statutes to file an EIS based
on the functional equivalency test. The
functional equivalency test holds that
where a Federal agency is engaged
primarily in an examination of en-
vironmental questions and full and ade-
quate consideration of environmental
issues are ensured, an EIS is not
necessary. This is the first case
specifically holding that EPA is not re-
quired to file an EIS when it takes ac-
tion under TSCA.
The most significant aspect of the
Court's opinion was the decision that
Warren County's ordinance is preemp-
ted by the provisions of TSCA
regulating disposal of PCBs because it
would present an obstacle to the ac-
complishment of Congress' statutory
plan under TSCA.
Warren County and the plaintiffs in
Twitty filed notices of appeal with the
U.S. Court of Appeals for the Fourth
Circuit. Warren County voluntarily
dismissed its appeal. Briefs were filed
in the Twitty appeal, which was set for
oral argument on October 6, 1982.
14
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National Association for the Advance-
ment of Colored People (NAACP) v.
Gorsuch, et al. (No. 82-768-CIV-5)
(E.D.N.C.)
On July 6, 1982, a NAACP chapter in
Warren County, North Carolina filed
suit against EPA and the State of
North Carolina seeking a preliminary in-
junction against construction of the
PCB landfill which was the subject of
the Warren County litigation.
Many of the issues raised in the earlier
litigation were raised in this case, but
several counts claiming violation of the
civil rights of Warren County black
residents were new. The complaint
alleged violation of 42 U.S.C. §§1981
and 1982 (general prohibitions against
abridgement of individual and property
rights), 42 U.S.C. §2000d (prohibition
against discrimination resulting from
Federal grants programs), and denial of
individual rights under the 13th
Amendment to the U.S. Constitution.
The court rejected all plaintiffs'
arguments in dismissing the case on
August 5, 1982.
Noble Automative Chemical and Oil
Co. v. EPA (No. 81-1581) (D.N.J.)
Noble Oil filed suit to enjoin ad-
ministrative penalty proceedings
against it for violations of PCB disposl
and marking regulations under TSCA.
Noble argued that EPA was acting to
enforce regulations which had been- in-
validated by the U.S. Court of Appeals
for the District of Columbia Circuit in
EOF v. EPA, supra. EPA argued that
the D.C. Circuit's opinion did not af-
fect the disposal and marking regula-
tions and filed a motion to dismiss
Noble Oil's case. The motions are cur-
rently under consideration by the
court.
The Scott & Fetzer Co. v. EPA
(D.D.C., No. 82-0861)
On April 27, 1982, the Court dismissed
a suit filed by the Scott & Fetzer Com-
pany challenging an EPA decision of
February 8, 1982, allowing Transco,
Inc. to distribute in commerce existing
stocks of PCB capacitors.
Scott & Fetzer's suit, filed on March
26, 1982, was based on Section 20 of
TSCA, which authorizes citizen suits
to compel EPA to perform non-
discretionary acts. Scott & Fetzer
argued that EPA had failed to perform
a nondiscretionary act when it allowed
Transco to distribute its capacitors.
In dismissing plaintiff's claim the court
held that nondiscretionary acts for pur-
poses of citizen suit provisions in en-
vironmental statutes are limited "to a
chosen few" mandatory duties; where
an official must exercise professional
judgment and draw upon his expertise,
the act is discretionary. The EPA deci-
sion complained of was just such a
discretionary act.
Aluminum Company of America v.
DuBois, (No. 81-3329, 9th Cir.)
Alcoa's appeal from a judgment in
Federal District Court that Section
11 (a) of TSCA authorizes EPA to
designate contractors as EPA represen-
tatives for purposes of performing in-
spections authorized by statute was
dismissed at the request of both par-
ties.
There is nothing further to report on
the following cases, which were noted
in last year's report:
Olin Corporation v. EPA (No.
79-1437, 4th Cir.)
General Electric Company v. EPA
(No. 79-1816, D.C. Cir.)
Aluminum Company of America v.
EPA (No. 79-1811, D.C. Cir.)
7. Mitchell Langdon et al. v. James
B. Hunt et al. (No, 86-487-CIV-5)
(E.D.N.C.)
Dow Chemical Company v. Douglas
Costle (Civ. Action No. 79-581, D.
Del.)
15
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VI. State Programs
State Programs. Section 28(c) of
TSCA authorizes EPA to award grants
to States for programs to prevent or
eliminate problems created by toxic
substances that EPA is unable or
unlikely to act on under TSCA. Since
1978, EPA has assisted eight states
with the development of 11 toxic
substances programs.
On August 28, 1978, EPA announced
in the Federal Register the availability
of $3 million for this Federal assistance
program and provided guidance to pro-
spective applicants. The announce-
ment also described a two-cycle award
process; approximately half the funds
were to be distributed in each cycle. In
April 1979, cooperative agreements
were signed with Maryland, Michigan,
New Jersey, New York, and Wisconsin
under the first cycle. In February'1980,
cooperative agreements were signed
with three States (New Jersey, North
Carolina, and Puerto Rico*).
On February 11, 1980, EPA announced
in the Federal Register the availability
of an additional $1.25 million for a third
and final cycle in the program. In
March 1981, cooperative agreements
were signed with four States (Illinois,
Maryland, Michigan, and Ohio).
However, Ohio decided not to proceed
with its project and returned its TSCA
grant funds.
Three State cooperative agreement
projects have been completed. These
projects are the Michigan Critical
Materials Program, the New York tox-
ics screening procedure study, and the
Wisconsin study of health problems
related to formaldehyde in mobile
home'construction.
The original funds Congress ap-
propriated for this program have been
awarded.
•As defined by TSCA, "State" includes any U.S.
territory or possession.
16
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Table 4
TSCA Section 28
State Cooperative Agreements Program
State/Department
Project Grant Descriptions and Status
Amount
Grant Period
Illinois Department of
Public Health
Maryland Department of
Health and Mental Hygiene
Maryland Department of
Health and Mental Hygiene
Michigan Department of
Natural Resources
Michigan Department of
Natural Resources
New Jersey Department of
Environmental Protection
New Jersey Department of
Environmental Protection
New York Department of
Environmental
Conservation r
North Carolina Office of
Natural Resources
Puerto Rico Environmental
Quality Board
Wisconsin Department of
Health and Social Sciences
Purpose: Develop an integrated voluntary system detecting morbidity and mortality rates resulting
from exposure to toxic substances.
Status: Wrote and disseminated a brochure and newsletter to State and local health officials and
medical professionals to explain the State Environmental Toxicology Program and obtain information
on disease clusters and trends in local communities. Follow-up investigations are being conducted by
the Department. Mortality information from 1964 to 1981 is being gathered, birth defects data is being
compiled and computerized as is the pilot cancer surveillance data from 16 counties.
Purpose: Develop a computer-based Toxic Substances Registry,
Status: The registry now contains 800 chemicals, an incidents record, cancer reports, all OSHA
violations, and a record of all occupational^ related diseases.
Purpose: Develop a program to assure the safe and effective containment of toxic substances in
storage tanks.
Status: The Ecology and Environment Corporation has been subcontracted to work on this project.
Technical studies underway.
Purpose: Develop an interdepartmental risk assessment process,
Status: Many risk assessment models have been reviewed and five major models selected for use by
the Departments of Natural Resources, Agriculture and Public Health. Extensive environmental fate
data has been gathered on 90 priority chemicals used or discharged in Michigan and 33 chemical
assessments have been completed. The Department of Agriculture continues to sample and analyze
for PCBs and heavy metals. The Department of Public Health has developed a computerized data
system handling the State's occupational Health exposure data.
Purpose: Critical Materials Program
Status: This project has been completed and the final report is being reviewed
Purpose: Set up a toxic substances investigation and integration unit; expand current project
monitoring volatile organic compounds in air.
Status: The Toxic Substances Investigation and Integration Unit has identified and investigated
various hazardous waste sites in New Jersey. Cancer and birth defects clusters are being investigated.
The mobile monitoring van is completed and is currently operating.
Purpose: Study movement, distribution and uptake of in-place mercury; monitor emissions of
selected toxic substances; assess the ecological effects of water contaminants; establish and operate
a Toxic Substances Information Resources Center; conduct a field application study of in vitro
mutagenesis tests.
Status: Additional sampling and biota have been collected and analyzed for mercury and other heavy
metals. Methods and resources required for sampling and analysis of various environmental emissions
from selected groups of facilities have been identified and field tested. Research on the effects of '
environmental stress in aquatic organisms continues. Summary reports of toxic substances research
are prepared along with other educational materials. Waste water samples have been assayed for
mutagenic activity using the Ames test.
Purpose: Identify, characterize and plan for managing toxic substances.
Status: New York has submitted a final report which is currently being reviewed.
Purpose: Identify, assess and plan to control toxic substances by profiling substances, identifying
sources and level and duration of exposures, and developing a plan to control substances posing an
unreasonable risk.
Status: North Carolina is preparing final report.
Purpose: Develop and manage the Commonwealth's toxic substances management strategy; expand
an existing public participation/awareness program.
Status: Developed and sponsored a meeting for the Inter-Agency Advisory Committee on Toxic
Substances Control. Prepared a questionnaire on PCBs for the industrial plants in Puerto Rico and
planned inspection visits.
Purpose: Study health problems related to formaldehyde vapors from mobil home construction
materials.
Status: This study is complete and the final report has been submitted.
$475,626
March 81-March 84
$230,963
$100,000
' $632,258
April 79-April 83
March 81-March 83
March 81-March 83
$504,500
$453,947
$794,053
April 79-Sept. 82
April 79-April 83
March 80-April 84
$348,000
$385,000
$258,394
$202,947
April 79-Nov. 82
March 80-Dec. 82
March 80-March 33
April 79-Sept. 82
17
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Appendix A
Summary/Guide to
Information Required
by Congress
Sections 30, 28(c), and 9(d) of TSCA
require that certain information be
reported each year to the President
and Congress. To assist readers in
locating this information, a summary of
each pertinent TSCA action and a ref-
erence to a more detailed explanation,
within this report, is given here.
Section 30. This section contains the
basic requirement for an Annual
Report and requests the following
information:
(1) Testing. No final Section 4 rules
for specific chemicals have been
issued. However, the Agency has
negotiated several testing agreements
with industry during FY'82. Without
formal rulemaking, industry represen-
tatives agree to perform specific
testing on designated chemicals and to
follow certain test protocols. See
Chemical Testing in Section III for ad-
ditional details and a list of the
negotiated agreements.
(2) Premanufactgre Notices
(PMIMs). EPA received 839 PMNs dur-
ing FY'82, bringing the total received
since the program's beginning in
mid-1979 to 1711. None of these
chemicals were subject to rulemaking
under Section 4. In approximately 30
cases, voluntary testing or control ac-
tivities took place in FY'82, while five
chemicals were subject to the develop-
ment of either a 5(e) or 5(f) order. See
Section II, Program Status.
(3) Rules Issued Under Section 6. A
final rule governing use of PCBs in
electrical equipment was signed on
August 18, 1982. The rule allows the
use of certain electrical equipment con-
taining PCBs to continue under
specific conditions.
A second final PCB rule was signed
October 12, 1982, providing for certain
exclusions from the 1979 ban on PCBs.
The regulation would exclude pro-
cesses that manufacture PCBs as by-
products and impurities as long as
PCBs released from the processes into
the air, water, or waste products do
not exceed limits stated in the rule.
Discussion of the two rulemakings is
contained in Section III, PCBs.
An ANPRM concerning dioxin wastes
was published January 5, 1982. The
notice solicited comments about
potential methods for disposing of
TCDD-contaminated wastes. See Sec-
tion III, Dioxin.
A final rule, published May 27, 1982,
requires public and private elementary
and secondary schools to identify
friable asbestos-containing building
materials, to maintain records of their
analyses and the location of friable
materials, and to notify school
employees and parents when friable
asbestos is found. See Section III,
Asbestos, for discussion of rule and
asbestos program.
(4) Judicial Actions Under TSCA
and Administrative Actions Under
Section 16. All judicial actions con-
cern PCBs. In FY'82, one suit was
filed, four petitions to review rulemak-
ing were filed, two suits were dismiss-
ed and six cases are pending. See Sec-
tion V, Litigation, for details.
A total of 93 PCB civil enforcement
cases were completed in FY'82. One
civil case involving compliance with
Section 8(e) of TSCA was also com-
pleted. A total of 108 PCB cases are
pending. See full discussion in Section
IV, Enforcement.
(5) Major Problems. No major pro-
blems were encountered in FY'82 in
administering TSCA.
(6) Recommended Legislation. No
legislative changes are sought at this
time.
Section 28{c). This section requires
a report on grants to States during the
year. Three State cooperative agree-
ment projects were completed in
FY'82. These were undertaken by
Michigan, New York and Wisconsin.
Eight additional State grants are due to
be completed in 1983 and 1984. See
description of projects in Section VI,
State Programs.
Section 9(d). This section requires
that EPA's efforts to coordinate its
TSCA activities with related activities
of other Federal agencies be reported
annually. During FY'82, EPA entered
into several formal and informal
agreements with other Federal govern-
ment programs concerning specific
chemical activities. These include a
Federal Asbestos Task Force (OSHA,
CPSC, EPA as charter members),
stratospheric monitoring (NOAA,
EPA), PCBs in food (FDA, EPA), infor-
mation development on formaldehyde
(NCTR, EPA), information exchange
under Section 8(e), as well as work
with several international organizations.
Details on these activities appear in the
appropriate sections of this report.
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Appendix B
FY'82 Chronology of Major TSCA Actions
Section of Law
Description
Date
4(a)
4(b)
4(c)
5(e)
5(e)
5(h)(4)
5(h)(4)
5(h)(4)
6(a)
6(a)
6(a)
6(a)
6(a)
6(a)
6(e)
6(e)
8(a)
8(a)
8(a)
8(d)
For listing of testing decisions see Table 2, Pgs. 10 & 11
Change in Test Standards Policy and Test Rule Development Process 3/26/82
TSCA Data Reimbursement (Proposed Rule) 6/4/82
Order; Ban pending development of additional data on two chemical dyes 10/9/81
Consent Order; Prohibit for consumer use pending development of test data on two 9/10/82
PMN chemicals
Premanufacture Notification; Exemption for Chemicals Used in or for Manufacture 6/1/82
or Processing of Instant Photographic and Peel-Apart Film Articles (Proposed
(Final Rule) 11/3/81)
Premanufacture Notification; Exemption for Site-Limited Intermediate Chemical 8/4/82
Substances and Chemical Substances Manufactured in Quantities of 10,000kg or Less
Per Year (Proposed Rule)
Premanufacture Notification; Exemption for Polymers (Proposed Rule) 8/4/82
Fully Halogenated Chlorofluoroalkanes; Exemption 1/5/82
Fully Halogenated Chlorofluoroalkanes; Exemption, Spinnerette Release Agents 1/5/82
Tetrachlorodibenzo-P-Dioxin; Reevaluation of Disposal Prohibition (ANPR) 1/5/82
Friable Asbestos-Containing Materials in Schools; Identification and Notification 5/27/82
(Final Rule)
Fully Halogenated Chlorofluoroalkanes; Temporary Special Exemption for Automatic 6/1/82
Timed-Released Insecticide Dispensing Systems Used in Storage of Tobacco
Fully Halogenated Chlorofluoroalkanes; Denial of Exemption for Use of 6/1/82
Chlorofluorocarbons in Automatic Timed-Release Insecticide Dispensing Systems Used
in Storage of Tobacco
Polychlorinated Biphenyls (PCBs); Manufacture, Processing, Distribution, and Use in 6/8/82
Closed and Controlled Waste Manufactured Processes (Proposed Rule)
Polychlorinated Biphenyls (PCBs); Manufacture, Processing, Distribution 8/25/82
Commerce and Use Prohibitions; Use in Electrical Equipment (Proposed
(Final Rule) 4/23/82)
Chemical Information Rules; Manufacturers Reporting Preliminary Assessment 6/22/82
Information (Final Rule)
Small Manufacturer Exemption Standards; Reporting and Recordkeeping Requirements 6/23/82
(Proposed Rule)
Asbestos Information Reporting (Final Rule) 7/30/82
Data Reporting; Submission of Lists and Copies of Health and Safety Studies 9/2/82
(Final Rule)
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