United States January 1986
Environmental Protection
Agency
Washington DC 20460
&EPA Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1985
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Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1985
Prepared by:
U.S. Environmental Protection Agency
Washington DC 20460
January 1986
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Contents
1. Introduction 1
2. Highlights 3
3. New Chemicals 9
Program Status 9
PMN Actions 10
Increased Testing 10
Category Evaluations 10
Exemptions 12
Biotectnology 12
Follow-Up Programs 13
4. Existing Chemicals 15
Program Status 15
Risk Identification 16
Section 8(d) Rule for Office of Solid Waste 17
TSCA Chemical Inventory Update Rule 18
Comprehensive Assessment Information Rule (CAIR).. 18
Chemical Hazard Information Profiles (CHIPs) 19
Section 21 Petitions 19
Monitoring 20
Underground Storage Tanks 21
Risk Evaluation 21
Methylene Chloride 22
Formaldehyde 22
Risk Assessments 22
Toxic Air Pollutants Strategy 22
Risk Management... •. >.. 23
Polychlorinated Biphenyls 23
Asbestos ; 25
4,4'-Methylenedianiline : ;... 27
1,3-Butadiene 27
Glycol Ethers.; i 28
Metalworking Fluids ;.....;.; 28
4,4'-Methylenebis(2-chlorobenz«enamine) 28
1,2,3,4,7,7-Hexachloronorbornadiene 29
Methyl n-Butyl Ketone 29
Chemical Advisories 29
5. Chemical Testing 31
Program Status 31
Streamlining Test Rulemaking 34
Single-Phase Rulemaking ,..,..,., i 34
Use-Based Cluster Analysis 34
Quality of Data 35
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6. Compliance and Enforcement 37
Program Actions 37
Compliance Actions 37
Civil Enforcement Actions 38
7. Litigation 41
8. International Acitivities 47
Tables
1 Summary of New Chemical Actions October 1,
1984 - September 30, 1985 11
2 Summary of Existing Chemical Actions 16
3 PCS Disposal Actions 24
4 Responses to Interagency Testing Committee (ITC)
Designations and Responses to Interagency Testing
Committee (ITC) Recommendations 32
5 Administrative Civil Actions Taken under section 16
of TSCA, Complaints Issued, Cases Completed, and
Amounts Assessed (by Regions) 40
Appendices
A Major FY 1985 TSCA Actions 50
B Summary/Guide to Information Required by
Congress 56
C Section 4 Test Studies Received 58
D Summary of NTP Studies .' 58
E Chemical Hazard Information Profiles (CHIPs) and
Substitute Hazard Profiles 59
F FY 1985 Section 21 Petitions 60
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Abbreviations
AAP Asbestos Action Program
ANPR Advance Notice of Proposed Rulemaking
ASHAA Asbestos School Hazard Abatement Act
CAIR Comprehensive Assessment Information Rule
CHIP Chemical Hazard Information Profile
CMA Chemical Manufacturers Association
CPSC Consumer Product Safety Commission
EDF Environmental Defense Fund
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide
Act
GLP Good Laboratory Practice
HESAP Health and Environmental Studies Audit Program
IPCS International Program on Chemical Safety
IRPTC International Register of Potentially Toxic
Chemicals
ITC Interagency Testing Committee
NBN National Blood Network
NHATS National Human Adipose Tissue Survey
NIOSH National Institute for Occupational Safety and
Health
NRDC Natural Resources Defense Council
NTA Negotiated Testing Agreement
NWF National Wildlife Federation
OECD Organization for Economic Cooperation and
Development
OPTS Office of Pesticides and Toxic Substances
OSHA Occupational Safety and Health Administration
OSW Office of Solid Waste
OTS Office of Toxic Substances
PAIR Preliminary Assessment Information Rule
PMN Premanufacture notification
RCRA Resource Conservation and Recovery Act
SEIU Service Employees International Union
SNUR Significant New Use Rule
TSCA Toxic Substances Control Act
UNEP United Nations Environment Program
WHO World Health Organization
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1
Introduction
This eighth Annual report to Congress summarizes the
Environmental Protection Agency's (EPA) activities and
accomplishments under the Toxic Substances Control Act
(TSCA) during Fiscal Year 1985 (see Appendix A). It
fulfills the Congressional reporting requirements of TSCA
sections 9(dj>, 28(c), and 30 (see Appendix B). Highlights of
significant Agency progress during the year are presented
in the next section of this report.
The Toxic Substances Control Act, which took effect on
January 1, 1977, charged EPA with protecting human
health and the environment from unreasonable risks of
injury fromtoxip chemicals. The Office of Toxic
Substances (OTS) under the direction of the EPA Assistant
Administrator for the Office of Pesticides and Toxic
Substances (OPTS) is responsible for implementing
mandatory and discretionary provisions of the Act.
The Act gives EPA broad authority to gather information
on chemicals su'bject to TSCA from manufacturers,
importers, processors, and other persons to identify
potential hazards to health and the environment. The law
enables EPA to/require companies to test chemicals where
necessary t0 obtain data needed to evaluate their risks. It
further requires companies to submit to EPA certain
specified information on all new chemicals before they
begin mam$(facture.Under TSCA, the Agency may select
from a broad range of regulatory control actions. These
range fronVhazard-warning labels to complete bans on
manufacture or. use of substances that present
unreasonable iisks. TSCA's regulatory authority covers
manufacturing, processing, distribution in commerce, use,
and disposal. To achieve a balanced regulatory approach,
however, the Act requires careful evaluation of the risks
posed by a substance weighed against the benefits
provided by the particular chemicals or classes of
chemicals and the costs of regulation. To ensure
compliance with regulations, TSCA authorizes both civil
and criminal penalties for violations. When TSCA is not
the most appropriate mechanism for a given exposure/risk
situation associated with a particular chemical, the Act
provides procedures for referral to other Federal agencies
for action.
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EPA now has a variety of programs to implement the
Act. Recordkeeping and reporting rules have been
promulgated and data are being collected on_a numheraof
chemical substances. Models have been developed to
determine the extent and methods of exposure to various
toxic substances, and surveys have been made to
determine current levels of exposures. Test rules and other
approaches to require industry testing where existing data
are inadequate have been developed and are providing
valuable toxicity information to support risk evaluations.
Laboratory inspections and data audits ensure the quality
and integrity of data received from industry as a result of
chemical testing. The Agency also has developed specific
strategies and tools to enforce TSCA regulations.
This eighth year of operation under TSCA finds EPA
continuing to improve and refine its programs to protect
human health and the environment from unreasonable
risks.
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2_
Highlights
Improved
Information
Collection
In FY 1985, EPA undertook a number of new initiatives to
improve and refine its regulatory processes and took
actions to address several significant hazards to human
health and the environment.
The Agency initiated a broader approach to gathering
information, and proposed a rule under TSCA section 8(d)
for the first time to acquire health and safety studies from
industry for use by another program. A model rule is being
developed for standardized comprehensive reporting on
existing chemicals under section 8(a). The Agency also
conducted broad-based monitoring to identify candidates
for further attention and evaluation. Risk evaluations were
undertaken based on reviews of data on groups of
chemicals, related by common function, market
application, or chemical structure. The Agency, with
participation by the public and industry, developed more
efficient methods and mechanisms for implementing
TSCA's testing provisions.
The Agency issued a comprehensive air toxics strategy
in FY 1985, and prepared criteria, an illustrative list of
substances, chemical specific profiles and guidance to
local communities for evaluating and responding to
accidental releases, for release to state and local
governments.
In FY 1985, EPA began developing a Comprehensive
Assessment Information Rule (CAIR) under section 8(a) of
TSCA, to consolidate into a model rule a wide range of
reporting provisions and questions. Reporting
requirements for a particular chemical can be specified by
identifying from the entire list of standard questions only
those that are needed by the users. Individual chemicals
can be added to the rule as the need arises with a
minimum of new rule development. This is expected to
reduce duplicative efforts and industry reporting burden.
Broad-based, as well as chemical-specific, monitoring
has been conducted to identify substances of potential
concern. A new analytical protocol was developed in FY
1985 for use in the National Human Adipose Tissue
Survey (NHATS). It improves-the utility of survey data to
detect TSCA-related chemicals" in human tissue. EPA
exposure teams also generated data to support risk
evaluation on several existing chemicals.
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Under the authority of section 8(a), on March 12, 1985,
the Agency proposed an Inventory Update rule (50 FR
9944) to require manufacturers/importers of chemical
substances to report current production volume and plant
site data on a critical portion of the more than 63,000
chemicals included on the TSCA Chemical Inventory. The
proposed rule represents the first update of the Inventory's
production data since 1977. It would cover substances
both originally reported for the Inventory as well as those
PMN substances subsequently added. The rule would
allow the Agency to obtain actual production data on
newly manufactured substances. The rule would require
both initial and recurring reporting — an updating
mechanism not a part of the original Inventory Reporting
Rule. It also would require every manufacturer, unless
exempt, to report.
Under the authority of section 8(d), EPA proposed a rule
(50 FR 40874) to require manufacturers, importers, and
processors of certain chemical substances to submit lists
and copies of pertinent unpublished health and safety
studies to assist the Office of Solid Waste in developing
health-based disposal standards. This marks the first time
that OTS has proposed to use TSCA to collect information
for another EPA program.
New Bisk In FY 1985,,OTS initiated a pilot study to develop an
Evaluation alternative to the current priority setting mechanisms for
Strategies both new and existing chemicals. The strategy involves a
"clustering" approach aimed at grouping chemicals into
categories by common function, market application,
structure or other similarity. This new approach will (1)
promote consistent analysis of chemicals that substitute
for each other in use, (2) focus resources on chemicals that
pose the greatest aggregate risk, and (3) reduce repetitive
analyses and rulemaking.
In the test rules program, a use-based clustering
approach is being considered. This approach will permit a
broad view of use/industry groups that incur large
collective burdens over time while at the same time
allowing EPA to focus resources in a cost-effective
manner.
In FY 1985, EPA began using this new approach
involving review of groups of new and existing chemicals.
Toxicity concerns are being evaluated for groups of
chemicals with common chemical structures rather than
one at a time. Under this approach, evaluation and
regulatory strategies are simultaneously conducted for both
new and existing members of selected chemical categories.
In FY 1985, OTS identified eleven chemical categories and
evaluated six for future regulatory action.
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Streamlining
Test
Rulemaking
Risk
Management
Actions
In FY 1985, the Agency developed two alternative
approaches to accelerate testing under section 4. On
May 17, 1985, EPA amended its rulemaking procedures
for test rules by adopting a new single-phase process. By
means of this approach, EPA will propose appropriate test
guidelines as the required .test standard in the initial
notice of proposed rulemaking. The final rule may then
promulgate as the test standard the previously proposed
test guidelines, a modified version, other suitable
guidelines, an alternative submitted by commenters, or a
modification of an alternative methodology. This approach
should shorten rulemaking and expedite testing. It also
reduces the industry burden to prepare and submit test
protocols for approval.
A series of public meetings was held in which industry,
an environmental group, and the Agency jointly developed
a new approach of using enforceable consent agreements
as an alternative to test rules, when consensus can be
reached on testing requirements. Such agreements may
expedite the initiation of testing, while providing
safeguards equivalent to those under test rules.
In FY 1985, EPA continued to implement the TSCA
section 6(e) prohibitions on polychlorinated biphenyls
(PCBs). A proposed and final rule addressed fire-related
risks associated with continued use of PCB transformers.
The final rule requires registration of PCB transformers
with fire departments and building owners by December 1,
1985, requires immediate reporting of all fire-related
incidents involving PCB transformers to the National
Response Center, requires removal of certain PCB
transformers in or near public buildings and places
additional restrictions on continued use of others. EPA
continued to promote industry participation in developing
safe PCB disposal methods through review and approval
procedures for disposal permits. In addition to high
temperature incineration, EPA has granted nationwide
permits for chemical dechlorination, and solvent
extraction. Regional permits have been granted for thermal
and biological treatment processes. Seven applications
were received during FY 1985, and three nationwide final
permits issued.
Asbestos continued to be a high EPA priority concern,
with special emphasis on abatement of asbestos hazards in
schools. In June, EPA offered $45 million in grants and
loans to school districts to assist in asbestos hazard
abatement in 340 schools. Awards were distributed to 47
states, the Northern Marianas and the Bureau of Indian
Affairs' schools. EPA also opened three Federally-financed
asbestos information centers in the greater Atlanta, Boston,
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and Kansas City areas. These centers offer courses to a
wide audience on proper identification and control of
asbestos-containing materials in buildings. In July, EPA
published an immediately effective rule to protect state
and local public employees who take part in asbestos
abatement projects. The Asbestos Abatement Projects Rule
establishes a permissible exposure level and requires use
of certain work practices during asbestos abatement.
A major risk evaluation and management action during
FY 1985 addressed risks from toxic air pollutants. In June
1985, EPA released a comprehensive air toxics strategy,
calling for control of hazards from both routine and
sudden accidental releases. An Agency-wide working
group prepared criteria and an initial list identifying
acutely toxic substances that could cause serious human
health effects from short-term exposures. In addition, the
Agency developed chemical-specific profiles for each of
the listed chemicals, including first aid information. This
information is intended to assist the public to prepare for
and respond to accidental toxic releases. Site-specific
guidance was also prepared for use by local communities
to evaluate the risks posed in their communities by
chemicals meeting the evaluation criteria. This
information will be available in early FY 1986.
The Agency announced a decision to initiate a priority
review under TSCA section 4(f) for risks of human cancer
from certain exposure to methylene chloride. Methylene
chloride, also known as dichloromethane, is a
non-flammable, colorless, volatile liquid with an ether-like
odor, used widely as a degreaser, aerosal propellant, and
solvent. Early in FY 1986, an Advance Notice of Proposed
Rulemaking will announce that EPA intends to conduct an
interagency comprehensive and integrated regulatory
investigation on this chemical.
In July, EPA referred a report on 4,4'-methylenedianiline
(4,4'-MDA) to the Occupational Safety and Health
Administration (OSHA) for regulatory consideration. EPA
asked OSHA to make findings as to the risk from
4,4'-MDA and OSHA's authority to prevent or reduce that
risk. Because the major exposures to 4,4'-MDA occur in
the workplace, EPA, submitting a report under section 9(a)
for the first time, gave OSHA the first opportunity to
regulate exposures to the chemical. EPA will refer another
report on 1,3-butadiene to OSHA based on EPA's
conclusion that exposure to the chemical presents an
unreasonable risk of cancer to workers. The report will be
published in the Federal Register in early FY 1986.
The Agency implemented two final rules during FY
1985 to exempt from the premanufacture notification
(PMN) process certain chemicals that would not present
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unreasonable risks to health or the environment. One
exemption rule is applicable to certain polymers; the other
is applicable to chemicals that are produced in small
amounts. Under these rules, eligible polymers and
low-volume chemicals will undergo an abbreviated 21-day
premanufacture notice review.
In support of the Office of Solid Waste and the 1984
Amendments to the Resource Conservation and Recovery
Act, concerning underground storage tanks, OTS
conducted a statistically-based national survey of motor
fuel tanks to assess the magnitude of the leaking tank
problem. The survey is providing a broad range of national
and regional statistics which will be used to determine if
the problem warrants Federal or State regulation.
Biotechnology Early in FY 1985 (December 31, 1984), EPA published a
proposed policy statement which described how the
Agency would apply TSCA and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) to new
commercial products of biotechnology. This statement was
published in a joint Federal Register notice with the White
House Office of Science and Technology Policy, the Food
and Drug Administration, and the U.S. Department of
Agriculture. After review and consideration of the
comments received, the Agency plans to issue a final
statement of policy on biotechnology early in 1986, again
in coordination with other Federal regulatory agencies.
Throughout FY 1985, the Agency has continued to work
with the other Federal agencies to coordinate Federal
biotechnology activities. The Agency has also continued to
support scientific conferences on biotechnology, and to
work with the Organization for Economic Cooperation and
Development (OECD) to harmonize international
approaches to biotechnology.
International
Activities
EPA continued to play an active role in FY 1985 in
international programs. EPA led an Organization for
Economic Cooperation and Development effort to develop a
Chemical Information Switchboard designed to increase
member stateaccess to unpublished information on
chemicals. The pilot Switchboard, with five countries
besides the U.S. participating, began operation on July 1,
1985. The Agency also participated in OECD chemical
program efforts involvinghazard assessment, good
laboratory practices, and confidentiality of data. During FY
1985, EPA was active on the OECD Test Guidelines
Updating Panel, reviewing new guidelines in genetic
toxicology and considering proposals to revise an acute
(eye irritation) toxicology guideline. In response to
the Bhopal, India tragedy, OTS participated in a United
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Nations' International Program on Chemical Safety (IPCS)
effort for a more effective international reaction to such
accidents.
Enforcement In FY 1985, EPA continued to enforce the provisions of
TSCA through inspections and by issuing civil and
criminal actions where violations were identified. In FY
1985, EPA inspections focused on PCBs (1,616
inspections), and asbestos-in-schools (2,014 inspections). In
addition, the Agency conducted 586 inspections of
chemical substances imports, 336 inspections on new
chemicals, 494 inspections for compliance with reporting
and recordkeeping under TSCA section 8, and 20
inspections of laboratories for compliance with
Good Laboratory Practices (GLPs).
In the enforcement area, 733 civil complaints were
issued. The majority of these were for asbestos-in-schools
(443) and PCB (253) violations. In FY1985, the Agency
issued the first complaints for violations of TSCA
section 8(a) (8), for TSCA section 13 import requirements
(12), and TSCA section 4 (3).
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3
New Chemicals
Program EPA reviews new chemicals prior to manufacture or
Status import as required by section 5 of TSCA. New chemicals
are defined as those that are not listed on the TSCA
Chemical Substances Inventory. This inventory of existing
chemicals is EPA's comprehensive list of chemical
substances in commerce. Manufacturers are required by
section 5 (a) to provide the Agency with a premanufacture
notification (PMN) ninety days in advance of manufacture
or import of a new chemical. EPA reviews and evaluates
the potential risk posed by the product and makes a
determination whether controls are appropriate, whether
additional data are needed, or whether production and use
should be prohibited.
Regulations under section 5 also require a manufacturer
to submit a Notice of Commencement of Manufacture
after an EPA review of the PMN is completed and prior to
the actual start of manufacture. This notice is given when
the manufacturer actually begins producing the substance.
It is at this point that a new chemical is added to the
TSCA Chemical Substances Inventory. TSCA also
authorizes EPA to track new chemicals that might be of
concern if their uses change, or if production volume
increases significantly after initial PMN review. Significant
new use rules (SNURs) provide a mechanism to
accomplish this task.
The New Chemicals Program provides for the review and
control of new chemicals to prevent large scale
distribution before a new substance's effects on health or
the environment are fully known. In addition, the program
includes (1) follow-up activities to ensure that risks are
limited during commercialization; and (2) special
exemptions from the PMN process of chemicals that are
found to not present an unreasonable risk.
With the standardized procedures and submission form
required by the final PMN rule, which became effective in
October 1983, the PMN program has evolved into a very
effective mechanism for identifying problems and
managing risks. The Agency can now consistently and
efficiently review the large number of PMN submissions it
receives.
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PMN Actions
Increased
Testing
Category
Evaluations
Since the establishment of TSCA, EPA has received an
increasing number of PMNs to review. In FY 1985, EPA
received 1,478 PMNs, bringing the total received since
inception of the program to 5,679. Most of the new
chemicals reviewed under this program did not require
regulatory action. Wherever necessary, however, the
Agency took appropriate action according to several
regulatory options available under section 5 of TSCA. The
Agency issued 37 section 5(e) orders controlling exposure
to 45 chemicals during FY 1985, bringing the total of PMN
chemicals affected by 5(e) orders since inception of the
program in 1979 to 218. In addition, 33 PMNs were
withdrawn by their submitters in FY 1985, in anticipation
of EPA action under section 5(e) or 5(f). Table 1
summarizes new chemical actions.
The Agency continued to make a concerted effort in 1985
to increase the quantity and quality of toxicity data on
PMN chemicals suspected of presenting unreasonable
risks. EPA has taken several approaches under section 5(e)
to obtain such data where the PMN revealed the need.
The Agency asks for testing before production begins if
the testing can be done quickly and without unreasonable
expense. EPA also asks for preproduction testing if the
potential risk cannot be adequately controlled pending
availability of the data. However, if the potential risk can
be controlled (e.g., by restricting use of the chemical, or by
requiring protective equipment for workers handling the
chemical), EPA issues "delayed trigger" testing orders
(under section 5(e)). Such orders require submission of test
data only when total production of the chemical reaches a
predetermined volume. Using these approaches, necessary
data are obtained to support evaluation of new chemicals,
adverse impact on industry innovation is limited, and
public health and the environment are protected from
unreasonable risk.
In FY 1985, EPA initiated an approach to the evaluation
and assessment of chemical categories. Individual
chemicals which can be grouped together because of
structure or use similarities, will be evaluated and
assessed as a category, not as individual chemicals. In
such evaluations, the Agency looks at both existing and
new members of the category, and strategies which
address both are then developed. Among other advantages,
this approach minimizes unintended "new chemical bias"
by simultaneously evaluating and developing strategies for
both new and existing members of selected chemical
categories. EPA expects evaluation and regulation will be
more efficient and effective when groups of comparable
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Table 1 Summary of New Chemical Actions
October 1, 1984-September 30, 1985
No. of Aggregated
PMN Total Since
Actions Beginning
in FY'85 (mid-1979)
Submissions of Bona Fide Intent to 571 2,088
Manufacture
Valid PMNs Received 1,478 5,679"
PMNs Requiring No Further Action 1,094 4,546
Voluntary Testing in Response to EPA 14 92
Concerns
Voluntary Control Actions by Submitters 7 44
PMNs Voluntarily Withdrawn in Light of 33 92
EPA Concern
PMNs Subject to section 5(e) Consent 45 218a
Orders*
PMNs Unilateral section 5(e) Orders* 1 15
PMNs Subject to section 5(f) Rules 0 4
Number of Chemicals for which 750** 2,580
Commencement of Manufacture Notices Were
Received
New Chemicals Subject to Proposed 19*** 42
Significant New Use Rules
New Chemicals Subject to Final Significant 12*** 14
New Use Rule
Valid Test Market Exemptions
Received 66 379
Granted 39 315
Granted with Modifications 9 19
Withdrawn 16 34
Denied 0 9
Polymer Exemptions 150 150
Granted 131 131
Withdrawn 19 19
Low Volume Exemptions 93 93
Granted 89 89
Withdrawn 4 4
Includes 106 synfuels.
*A consent 5(e) order is.issued by EPA with the agreement of thfe PMN
submitter. A unilateral 5(e) order is issued by EPA without the agreement
of the PMN submitter.
**This number includes PMNs received in previous fiscal years for
which commencement of manufacture notices were received in FY 1985.
***This number includes chemicals which were the subjects of PMNs
received in previous fiscal years but for which proposed or final rules
were not published until FY 1985.
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Exemptions
chemicals are dealt with by category, rather than on a
one-by-one basis, as has traditionally been done.
In FY 1985, OTS identified 11 chemical categories based
on structural similarities, and selected six for further
evaluation. For each of the six, a preliminary strategy has
been developed to characterize the toxicity, exposure and
risk, and to develop regulations as needed. FY 1986 plans
call for implementing some elements of the strategies for
two of the categories by drafting regulations; three will
undergo further evaluation; and one category has been
determined to be inappropriate for further consideration.
Categories may be based on chemical structure, use,
physical-chemical properties, exposure, or other common
elements or combinations of elements.
EPA is authorized to exempt chemicals from the PMN
process if the Agency finds that such chemicals will not
. present an unreasonable risk of injury to health or the
environment (section 5(h)(4)). In 1985, EPA implemented
two final rules to exempt certain chemicals from full
notice and review requirements. One rule applied to
polymers with a number average molecular weight greater
than 1,000 grams per mole, and polyesters manufactured
solely from a list of approved reactants. This rule became
effective in January 1985. The second rule exempted
chemicals that are produced in small amounts (i.e., less
than 1,000 kg/yr). This rule was implemented in June
1985. Under both exemption rules, eligible polymers and
low volume chemicals are now subject to a shortened,
21-day review period, and to abbreviated notice
requirements. The Agency has been reviewing an average
of 15 polymer and 20 low-volume exemption notices per
month.
Biotechnology Early in FY 1985 (December 1984), EPA published a
proposed policy statement clarifying the applicability of
TSCA and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) to new microorganisms produced
through biotechnology and used .commercially. With this
statement, the Agency committed to protecting human
health and the environment while not inhibiting the
development of beneficial biotechnological products and
uses. During FY 1985, EPA has continued to analyze policy
options and refine its program for reviewing
biotechnological products under TSCA.
EPA's proposed policy statement was published on
December 31, 1984, in a joint federal Register notice with
the Office of Science and Technology Policy, the Food and
Drug Administration, and the Department of Agriculture.
The major issue in the TSCA portion was the applicability
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of TSCA section 5 PMN authority to biotechnology
products. The Agency proposed an approach and
requested comments. There were 71 comments from 68
different respondents received by the close of the
comment period on April 15, 1985. These comments are
being analyzed by the Agency for use in developing its
next statement of policy on biotechnology, which is
expected to be issued in early 1986 in coordination with
the other Federal regulatory agencies.
The Agency continued to participate during FY 1985 in
the Working Group on Biotechnology, established by the
Cabinet Council on Natural Resources and the
Environment. This group discusses major Federal
interagency issues in biotechnology and develops a
coordinated position on them.
EPA has contributed to the planning of a number of
scientific conferences on biotechnology during FY 1985,
all aimed at developing better information on which to
base regulatory decisions in this important area. For
example, EPA participated in the planning and conduct of
a cross disciplinary symposium on "Engineered Organisms
in the Environment: Scientific Issues," held June 10-13 in
Philadelphia. The Agency also helped to fund and
organize a scientific workshop on physical and biological
containment of organisms, held October 1-4 at Shackelton
Point, N.Y., as well as many other similar workshops and
conferences held throughout the year.
In the international area, EPA participated as a member
of the U.S. delegation to the Organization for Economic
Cooperation and Development (OECD) Working Group on
Safety and Regulation of Biotechnology. This group is
producing a report on health and safety considerations
associated with commercial applications of genetically
engineered organisms. The report is being developed as a
step toward harmonization of international approaches to
biotechnology. It includes sections on large-scale
commercial and environmental use of the products of
biotechnology.
The Agency continues to be active in formulating,
implementing and assessing the research program in
biotechnology that is being conducted by its Office of
Research and Development. The research is designed to
increase the body of knowledge available to support risk
assessments for biotechnology products.
Follow-up An important aspect of both the premanufacture review
Program program and the existing chemicals program is the policy
to continue to monitor both new and existing chemicals
that may be of concern if their uses change, or production
volumes significantly increase from those estimated during
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their initial review. EPA uses several regulatory authorities
including its significant new use rule authority under
section 5(a) to accomplish this purpose. Significant new
use rules (SNURs) are also used to extend the terms and
conditions of section 5(e] orders to other manufacturers
and processors of the same chemical who otherwise could
make or process the chemical without the restrictions
placed on the original submitter.
EPA must be notified at least 90 days in advance of the
date any person begins to manufacture or process a
chemical for a significant new use. EPA then reviews this
notice to see if the new use might present an unreasonable
risk. All new and existing chemical regulatory authorities
are available if needed.
EPA proposed 10 SNURs covering 19 new chemicals in
FY 1985 and promulgated 7 SNURs covering 12 chemicals
to regulate the manufacture, import, or processing of a
chemical subject to a SNUR (see Appendix A).
In addition to the SNURs on new chemicals, EPA also
proposed two SNURs on two existing chemicals, using
section 5 authority.
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4
Existing Chemicals
Program The OTS Existing Chemicals Program goal is to reduce
Status unreasonable risks of injury to health or the environment
from chemicals already in commerce. Specifically, the
objectives of this program are: (1) to identify risks to the
public health and environment; (2) to evaluate those risks;
and (3) to ensure that risks are addressed and appropriate
risk management actions taken under TSCA or other
relevant authority. TSCA addresses all phases of a
chemical's life cycle, including manufacture, processing,
distribution, use, and disposal.
EPA identifies potential risks, using TSCA section 8
authorities to gather information about the toxicity of
particular chemicals and the extent to which people and
the environment are exposed to them. TSCA section 4
authorizes EPA to require testing by manufacturers and
processors of designated chemicals where necessary to
obtain needed data.
The Agency evaluates and determines the actual
character of the risks by analyzing the gathered data. A
risk assessment on a given chemical is made based on
exposure and health and environmental effects data.
From the available information and the risk assessment,
a decision is made regarding the need for risk management
actions. Alternative risk management actions are identified
and evaluated, considering effectiveness and cost factors.
The Agency focuses its efforts on the potential risks of
greatest concern. Finally, EPA implements the appropriate
risk management actions. Provisions of section 5 (i.e.,
significant new use rules), as well as nonregulatory tools
(such as chemical advisories) can be used to monitor or
warn of situations which raise some concern, but are not
suitable for immediate regulation. EPA can control
unreasonable risks through regulatory action under the
authority of section 5 or 6 or require immediate
elimination of any imminent hazards under section 7.
When TSCA is not the most appropriate mechanism for a
given exposure/risk situation associated with a chemical of
concern^ section 9 governs the procedures for referral to
other Federal^agencies for action.
Only those chemicals for which unreasonable risks are
identified will be addressed in all phases of the program
described above. Chemicals found to not pose
unreasonable risks are dropped from further evaluation;
15
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Table 2
and resources are reprogrammed toward evaluation of
other more potentially hazardous chemicals.
During FY 1985, 83 chemicals were subjected to the
Existing Chemicals Program review process. Of that
number, 21 were dropped, 11 were referred for risk
management, 7 were referred for information gathering,
and 48 are undergoing further evaluation. (A summary of
existing chemical program activities is provided in Table 2.)
Summary of Existing Chemical Actions
# In FY 1985
Risk Identification
Testing Studies Received under Section 4 (see Appendix C) 102
Section 8(a) Preliminary Assessment Reports Received 201
Section 8(d) Health and Safety Studies Received 549
Section 8(e) Substantial Risk Notification Program: 439
- Initial 8(e) Submissions 37
- Supplemental/Followup 8(e) Submissions 99
- "For Your Information" (FYI) Submissions 303
Chemical Hazard Information Profiles (see Appendix E) 16
Substitute Hazard Profiles (see Appendix E) 23
Section 21 Petitions Received (see Appendix F) 2
National Toxicology Program Studies Reviewed (see 16
Appendix D)
Risk Evaluation
- Dropped from further evaluation 21
- Continued assessment 48
- Referred for risk management 11
- Section 4(f) designations 1
- Referred for information gathering 7
Risk Management
Proposed and final rules under section 6(e) 5
Chemical Advisories 2
Significant new use rules proposed 2
Section 9 Referral 1
Risk
Identification
Section 8 of TSCA authorizes EPA to require reporting and
recordkeeping on chemical substances and mixtures.
Section 8(a) authorizes EPA to promulgate rules requiring
manufacturers, importers, and processors to maintain
records and report certain information to the Agency.
Under section 8(a], there is a Preliminary Assessment
Information Rule (PAIR) which requires manufacturers of
listed chemicals to report general production, use and
16
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exposure information. These data are especially important
to the Agency's review of chemicals designatediby the
Interagency Testing Committee (ITC) for priority testing
consideration. Under section 8(c), manufacturers and
certain processors must maintain records alleged
"significant adverse reactions." This information must be
provided to EPA upon request. Section 8(d) requires
certain manufacturers, processors, and distributors to
submit lists of actual unpublished health and safety
studies to EPA. Section 8(e) requires that EPA be notified
when there is new information which reasonably supports
the conclusion that a chemical substance or mixture
presents a "substantial risk" to health or environment.
Such notification must be given to the Agency
immediately upon discovery. The Agency also receives a
large number of "For Your Information" submissions
related to chemical toxicity and exposure. This
information may be submitted by institutions which do
not have a section 8(e) reporting responsibility (e.g., trade
associations, academic institutions) or by companies in
cases where the information does not meet section 8(e)
criteria. Another source of data on existing chemicals risks
is the National Toxicology Program, from whjch test data
are received and routinely reviewed.
In FY 1985, the existing chemicals program received and
reviewed a substantial amount of data on existing
chemicals (see Table 2). During the fiscal year, section 8(a)
and 8(d) rules were amended to require reporting on 15
additional chemicals. Section 8(a) and section 8(d) rules
resulted in submission by the chemical industry of 750
studies and reports on existing chemicals. Under the
section 8(e) substantial risk notification program, EPA
received 37 initial reports, 99 supplements related to
previous section 8(e) initial reports, and 303 "For Your
Information" (FYI) submissions, totalling 439 for FY 1985.
A total of 102 completed test studies required under
section 4 were received from industry (see Appendix C).
Sixteen National Toxicology Program studies were also
received and reviewed by OTS (see Appendix D).
Section 8(d) Rule EPA proposed a rule under section 8(d) of TSCA (50 FR
for Office of Solid 40874) that will require manufacturers, importers, and
Waste (OSW) processors of 33 listed chemical substances to submit to
EPA lists and copies of unpublished health and safety
studies on those substances. The 33 substances listed in
the proposed rule were nominated by the Office of Solid
Waste, which requires the information in order to develop
health-based standards for the disposal of solid waste. The
health-based standards are needed to meet certain land
disposal restrictions provisions of the Hazardous and Solid
Waste Amendments of 1984. This rulemaking marks the
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TSCA Chemical
Inventory
Update Rule
Comprehensive
Assessment
Information Rule
(CAIR)
first time that OTS has specifically developed a rule under
TSCA authority to collect information needed for another
EPA program.
On March 12, 1985, the Agency issued a proposed section
8(a) rule (50 FR 9944) that would require
manufacturers/importers of chemical substances to report
current production volume and plant site data on a critical
portion of the more than 63,000 chemicals included on the
TSCA Chemical Inventory. The proposed rule represents
the first update of the Inventory's production data since
1977. The rule would cover substances both originally
reported for the Inventory as well as those PMN
substances subsequently added. This will allow the
Agency to obtain actual production data on newly
manufactured substances as well as update information on
chemicals already listed. The rule would require both
initial and recurring reporting, a self-correcting mechanism
that was not included in the.original.inventory reporting
rule. This rule-Would require every manufacturer, unless
exempt, to report. Exempt- persons and/or substances
include small manufacturers who satisfy specific criteria;
persons who manufacture or import chemical substances
in limited circumstances or through coincidental
manufacture; and substances that include polymers,
inorganics, microorganisms, naturally occurring chemical
substances, and substances with an annual site-specific
production volume of less than 10,000 pounds.
A reportable substance under this rule is essentially any
non-polymeric synthetic organic chemical substance with
an annual site-specific production volume of 10,000
pounds or more. For each of the reportable substances,
every manufacturer/importer subject to this rule will be
required to submit current data every four years, for as
long as this rule is in effect. A final rule is expected to be
promulgated by the end of the calendar year. Initial
reporting under this rule would begin early in 1986.
In an effort to improve and simplify data gathering
procedures under section 8(a) for existing chemicals, EPA
is developing a Comprehensive Assessment Information
Rule (CAIR). It is designed to consolidate a comprehensive
list of reporting provisions and questions into a model
rule. A standard list of questions will be established from
which specific reporting requirements for various
chemicals may be selected. Reporting would be required
on only those data elements, from the entire list of
questions, that are of primary interest to the users of the
data. The rule would be used to obtain information needed
by EPA and other Federal agencies to support assessment
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Chemical Hazard
Information
Profiles (CHIPs)
Section 21
Petitions
and regulation of chemical substances and mixtures.
Chemical specific rules would still be promulgated in
certain cases where the CAIR questions cannot obtain the
required information.
Under this rule, reporting requirements on individual
chemicals could then be developed quickly by simply
adding the chemicals to the rule. The requirements could
be tailored to meet specific: data needs by specifying the
questions to be answered. The rule is expected to reduce
duplicative effort within EPA and the Government as well
as industry reporting burdens.
In FY 1985, EPA prepared Chemical Hazard Information
Profile (CHIP) documents for 16 chemicals (see Appendix
E). CHIP candidates are selected from chemcials reviewed
in the risk identification phase of the existing chemical
review process. They are brief summaries of readily
available information concerning the health and
environmental effects and exposure potential of a
chemical. Information-gathering for a CHIP consists
primarily of a search of secondary literature sources
including computerized data bases, abstracts, government
reports, scientific review documents, and reference works.
During CHIP preparation, EPA also solicits information
from companies, other government agencies and other
institutions involved in chemical risk assessment.
There also were 23 Substitute Hazard Profiles prepared
in FY 1985 (see Appendix E). As part of the overall risk
identification and evaluation process, potential substitutes
for a chemical being considered for risk management are
identified. Substitute Hazard Profiles, similar in content
and format to CHIPs, are preliminary risk identification
documents prepared to ensure that any TSCA regulatory
action will not encourage the substitution of even more
hazardous chemicals for the chemical being considered for
risk reduction action.
Section 21 of TSCA is a means by which any citizen may
request EPA to initiate action. Under this section, any
person may petition the EPA Administrator to initiate a
proceeding for issuing, amending, or repealing a rule
under various sections of the Act. EPA may either grant or
deny the petition. If it is granted, EPA must promptly
commence an appropriate proceeding under section 4, 5,
6, or 8 of the Act. Denials must be published in the
Federal Register with the reasons for the denial. If EPA
denies the petition or fails to act within 90 days, the
petitioner may begin a civil action in a U.S.District Court.
Two petitions were received in FY 1985; action was also
taken on two previously submitted petitions (see
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Appendix F). During this fiscal year, one petition was
granted. Another petition submitted by the Environmental
Defense Fund and the National Wildlife Federation was
partially granted, resulting in a regulatory investigation of
dioxins and furans. Regulatory actions under sections 4
and 8 are being considered. Guidance for preparing
citizens' petitions under section 21 was developed in FY
1985. Petitioners' use of this guidance will assist the
Agency to properly evaluate citizens' petitions within the
90-day review mandated by the'statute. This guidance will
also assist petitioners in effectively presenting their cases
to EPA with the most pertinent available support. The
guidance will be published in early FY 1986.
Monitoring Another EPA program supporting regulatory
decisionmaking on existing chemicals is OTS'
chemical-specific and broad-based monitoring activities.
Chemical-specific studies are conducted to obtain data on
levels of human and environmental exposure to specific
substances of concern. Broadbased studies serve to
identify substances of potential concern. These studies
help EPA plan future TSCA ambient monitoring programs,
identify candidates for testing (under section 4) or for
regulatory controls under other TSCA authorities, and
evaluate the effectiveness of TSCA actions in protecting
human health and the environment.
In FY 1985, a new analytical protocol was developed
and implemented for use in the National Human Adipose
Tissue Survey (NHATS). This survey, in 1984, produced
the first human exposure-based chemical list for OTS
review to identify potential unreasonable risks. The new
protocol improves the utility of the survey data to detect
TSCA related chemicals in human tissue. In addition, the
NHATS survey design was modified in 1985 to allow
statistically valid human exposure estimates to be made
for each EPA Region as well as for the usual U.S. Census
Divisions.
Chemical exposure support activities generated data
used for seven existing chemicals. Those actions included
occupational monitoring of exposure to acrylamide,
needed for a risk assessment; laboratory analysis of
consumer products containing glycol ethers, subject of
possible TSCA regulatory action; experiments to measure
exposure-reduction potential of several methods for
transfer of dry 4,4'-methylenebis(2-chloroaniline)
(MBOCA), a demonstrated animal carcinogen used in the
manufacture of certain polyurethane elastomeric articles; a
survey, air and water monitoring, and multiple dermal
absorption tests for 4,4'-methylenedianiline, subject of a
TSCA section 9 referral to the Occupational Safety and
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Underground
Storage Tanks
Health Administration (OSHA); a comprehensive
preliminary exposure assessment on methylene chloride,
in support of a TSCA section 4(f) priority review
regulatory decision; an interagency field survey with the
National Institute for Occupational Safety and Health
(NIOSH) of the entire monomer and polymer industry for
1,3-butadiene, the subject of a TSCA section 9 referral; and
initiation of a field study in the textile industry to assess
exposure to dyes, a persistent concern to both workers and
the environment.
In FY 1985, OTS conducted the National Survey of
Underground Motor Fuel Storage Tanks, in support of the
Office of Solid Waste and the 1984 Amendment to the
Resources Conservation and Recovery Act (RCRA). The
purpose of the survey was to attempt to extrapolate the
magnitude of the leaking tank problem and provide
statistics for determining appropriate Federal or State
regulation.
The Agency's immediate concern with leaking tanks is
groundwater contamination. Half of the population of the
U.S. depends on groundwater from community or private
wells for their water supplies. There is a growing body of
data showing that motor fuels are contaminating
groundwater, and that leaking underground motor fuel
storage tanks are the source of this contamination. Once
groundwater is contaminated, it is very difficult and costly
to purify the water for human consumption or agricultural
use.
Designed and field tested in 1984, the survey is
providing a broad range of unbiased national and regional
statistics on underground tanks and tank leakage. The
survey is based on a scientific sample of approximately
900 establishments with approximately 2,500 tanks. The
survey includes on-site interviews of tank owners or
operators, collection and analysis of tank-productivity
data, and physical tightness testing of more than 500 of
the 2,500 tanks. All field operations were completed in FY
1985, and a final report will be available in early 1986.
Risk Major risk evaluation activities in FY 1985 focused on a
Evaluation section 4(f) priority review of methylene chloride and a
regulatory investigation of formaldehyde. The Agency
prepared risk assessment documents on six potentially
hazardous chemicals. A major toxic air pollution strategy
was released by the Agency, with substantial OTS efforts
in the area of sudden accidental releases.
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Methylene
Chloride
Formaldehyde
In March 1985, EPA received bioassay data which showed
that methylene chloride was carcinogenic in two species
of laboratory animals. On May 14, 1985 (50 FR 20126)
EPA, under section 4(f) of TSCA, announced that certain
exposures to methylene chloride may present a significant
risk of serious or widespread harm to humans from cancer.
Methylene chloride is a high-volume chemical with a
variety of uses such as a solvent, aerosol propellent, and
degreaser, among other applications. In early FY 1986, the
Agency published an Advance Notice of Proposed
Rulemaking (ANPR), announcing EPA's plans to conduct a
comprehensive interagency regulatory investigation of
exposures to methylene chloride.
In May 1984, EPA announced a high-priority review
(under section 4(f)) of formaldehyde exposure of the two
largest exposed populations to this chemical:
permanent-press apparel manufacturing workers and
residents of mobile and conventional houses built with
urea-formaldehyde construction products. The ongoing
regulatory investigation during FY 1985 has evaluated the
carcinogenic and noncarcinogenic risks of exposure, the
economic costs of possible control options, and the
appropriateness of further EPA action to reduce the risk
versus action by other Federal agencies. Selection of risk
management options is continuing.
Risk Assessments Six risk assessment documents were prepared in FY 1985.
They addressed 1,3-butadiene, a monomer used in
manufacturing rubber and other polymer products;
4,4'-methylenedianiline, used primarily as an intermediate
in the manufacture of other chemicals and plastics;
formaldehyde, used in both apparel and wood products;
methylene chloride, a solvent with many commercial and
industrial uses; chlorinated paraffins, used as additives to
metalworking fluids, plasticizers, and flame retardants;
and cutting fluids, used as lubricants on machine-shop
cutting tools. In addition, the results of a risk assessment
on glycol ethers provided the basis for an Environmental
Health Criteria document prepared by the World Health
Organization (WHO). Such WHO documents are used for
assisting member nations to establish worldwide standards
for subject substances.
Toxic
Air Pollutants
Strategy
A major EPA risk evaluation initiative during FY 1985
addressed risks from toxic air pollutants. This year has
seen a number of significant releases of acutely hazardous
chemicals into the atmosphere, most notably that which
occurred in Bhopal, India, in December 1984. In June
1985, the Agency released a comprehensive air toxics
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Risk
Management
Polychlorinated
Biphenyls
strategy. The strategy calls for controlling hazards from
both routine releases and sudden, accidental releases.
For routine releases, EPA will continue to use
authorities under the Clean Air Act. The Agency is
enhancing Federal support so states can improve their
capability to deal with air toxics within their own borders.
For sudden, accidental releases, the strategy calls for
improving emergency preparedness and response at all
levels of government to prepare for and respond to
accidental toxic releases. OTS headed an Agency-wide
working group that developed criteria and an initial list of
acutely toxic substances. The purpose of the criteria and
the list is to identify those chemicals that are able to cause
serious human health effects from short-term exposures.
Exposure through the air is of most concern because of the
inability of exposed individuals to avoid contact with the
chemical. The working group also prepared site-specific
guidance to be used by local communities to evaluate the
risks posed in their community by the chemicals meeting
the criteria. These activities are being coordinated with the
activities of the Office of Solid Waste to develop guidance
for organizing a community to evaluate the risks of
significant hazardous releases and emergency
preparedness and response plans.
Risk management activities in FY 1985 resulted in TSCA
section 6 actions or section 9 referrals on polychlorinated
biphenyls, asbestos abatement, 4,4'-methylenedianiline,
and 1,3-butadiene. The Agency also developed section 5
significant new use rules (SNURs) to monitor the future
manufacture of several existing chemicals, including
4,4'-methylenebis(2-chlorobenzenamine) (MBOCA), methyl
n-butyl ketone (MBK), and hexachloronorbornadiene
(HexBCH). Descriptions of some of the more significant FY
1985 activities are presented below.
In FY 1985, EPA continued to implement the TSCA
section 6(e) prohibitions on polychlorinated biphenyls
(PCBs) by issuing 2 notices of proposed rulemaking, 2
final rules and one final action by rule.
The proposed PCB Transformer Fires Rule (49 FR 39966)
and. the final PCB Transformer Fires Rule (50 FR 29170)
addressed the fire-related risks associated with the
continued use of PCB Transformers. The final rule places
restrictions and conditions on the continued use of
PCB containing transformers to reduce the frequency of
fire related incidents, as well as the risks in the event of a
fire involving this equipment. In compliance with a
court ordered deadline, I^A issued a final rule (49 FR
44634) modifying the definition of "totally enclosed
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manner" to more accurately reflect the Agency's
framework for assessing PCB exposure. On August 29,
1985, EPA issued a proposed rule responding to petitions
for exemption from the prohibitions on PCBs (50 FR
35182) and a notice of denial on a petition for exemption
(50 FR 35192). On April 4, the Agency issued a proposed
rule incorporating by reference certain American Society
for Testing and Materials test methods to be used to meet
particular PCB testing requirements (50 FR 13393).
In support of the PCB Transformer Fires Rule, the
Agency conducted a study on the formation of
polychlorinated dibenzodioxins (PCDDs) and
polychlorinated dibenzofurans (PCDFs) as combustion
by-products of PCB dielectric fluids. That study also
looked at the combustion by-products of substitute
dielectric fluids.
In March 1983, EPA issued a procedural amendment to
the PCB rule, entrusting the Office of Pesticides and Toxic
Substances with the authority to review and issue
nationwide approval for various types of processes for
safely disposing of PCBs. The nature of a nationwide
approval is to allow PCB disposal facilities to be used in
more than one region, eliminating duplication of effort in
the 10 regional offices and unifying the Agency's approach
to PCB disposal. These types of processes approved at the
national level extend beyond high temperature
incineration. As EPA's PCB regulations have evolved, so
has industry's innovativeness. Nationwide permits have
been granted for alternative methods of PCB destruction.
These methods include chemical dechlorination and
solvent extraction. Regional permits have been granted for
thermal and biological treatment processes.
EPA continues to promote industry participation in the
development of PCB destruction methods with the
objective of attaining safe handling of these toxic
chemicals. Accomplishments to date in FY 1985 include
issuing 4 research and development (R&D) permits, 7
demonstration permits, and 8 nationwide disposal permits.
Table 3 Actions on Nationwide PCB Disposal Permits FY 1985
Applications Received: 9
R&D Permits Issued: 4
Permit Deficiency Letters: 11
Demonstration Permits Issued: 7
Nationwide Final Permits Issued: 8
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Asbestos Asbestos continued to be a high priority concern for EPA
in FY 1985. A new office, the Asbestos Action Program
(AAP), was created to administer the Asbestos School
Hazard Abatement Act (ASHAA) of FY 1984, and provide
technical assistance in supporting school abatement
projects. In support of ASHAA, EPA produced a state
application packet for Federal monies. The ASHAA
established a loan and grant program to support abatement
programs in schools with the most serious asbestos
problems and demonstrated financial need. The
application packet requested information from school
districts, detailing the condition of public and private
school buildings and finances within the individual school
districts.
In June 1985, EPA awarded $45 million in grants and
loans to school districts to assist in the abatement of
asbestos hazards in 340 schools. Approximately 5,000
schools had applied for funds under the ASHAA
administered by EPA. The awards were distributed to 47
states, the Northern Marianas, and Bureau of Indian
Affairs' schools.
As part of the nationwide drive to provide information
and training on the identification and abatement of
potential asbestos hazards, EPA opened three
Federally-financed asbestos information centers. They are
located in the greater Atlanta, Boston, and Kansas City
areas. The centers train people in proper asbestos
identification and abatement techniques. Funds for the
first centers were awarded to Georgia Tech, Tufts
University, and the University of Kansas. EPA is
considering whether to open additional centers.
Since 1979, EPA has provided technical assistance on
asbestos abatement to school officials and building owners
and managers. In FY 1985, the Agency completed a
number of informational guidance documents to help
educate the public about asbestos in buildings and how to
reduce the hazard. Several publications were completed
and distributed publicly in FY 1985. In July, 1985, the
Agency completed the revision of the EPA 1982 asbestos
guidance document. The newly revised document is
entitled "Guidance for Controlling Asbestos-Containing
Materials in Buildings." The 1985 edition provides more
comprehensive instruction for the treatment of
asbestos-containing materials. The information presented
in the new version was compiled by a panel of national
experts in asbestos identification and control.
To complement the new guidance document, OTS
coordinated with EPA's Office of Research and
Development (Environmental Monitoring Systems
Laboratory, Research Triangle Park) to coproduce
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"Measuring Airborne Asbestos Following an Abatement
Action." The document presents specific guidance on the
determination of the acceptable completion of an
abatement project. A panel of national experts met and
discussed the issues involved in deciding whether a
worksite is "clean" following an abatement activity.
A third publication, "Asbestos in Buildings: Guidance
for for Service and Maintenance Personnel," was
completed and has been made available. The manual
provides custodial workers information on practices to
minimize unnecessary exposure to asbestos during normal
service and maintenance activities.
The survey, "Asbestos in Buildings: A National Survey
of Asbestos-Containing Friable Materials," was published
in FY 1985 as a result of a national survey conducted in
FY 1984 to determine the extent of asbestos-containing
friable materials in schools. Asbestos technical bulletins
comprise another source of information. Bulletins
produced in 1985 include "Evaluating Compliance with
the Asbestos-In-Schools Identification and Notification
Rule" and "Use of Asbestos-Containing Friable Materials
and Vinyl-Asbestos Floor Tiles in Public and Commercial
Buildings." A bulletin on the handling of
asbestos-containing pipe wrap will be distributed in the
Spring of 1986.
Another form of EPA assistance is to encourage states to
establish contractor certification programs. This program
provides grants to states for the purpose of developing and
carrying out certification programs and giving technical
assistance. Eleven states received funding in FY 1985, and
an additional fifteen states are expected to be funded in
FY 1986. For FY 1986, contractors who conduct asbestos
abatement work under the Asbestos School Hazard
Abatement Act (ASHAA) either must be state certified or
must have attended an EPA-approved training course.
EPA awarded a grant to the Maryland Department of
Health and Mental Hygiene to develop a model asbestos
abatement contractor certification program based on
Maryland's existing program. Maryland prepared
"Recommended Guidelines for Asbestos Abatement
Contractor Licensing Programs" in April 1985. EPA
distributed this model state regulation to all of the states
and sponsored three model workshops on this document
in Atlanta, San Francisco, and Boston between April 24,
1985 and June 21, 1985. State officials and the public were
invited to the workshops. In addition, EPA has developed
and made available to the states a model training program
for abatement contractors. This program was presented to
18 states on July 8, 1985.
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4,4'-Methylene-
dianiline
(4,4'-MDA)
1,3-Butadiene
On July 12, 1985, EPA proposed the Asbestos Abatement
Projects Rule under section 6 of TSCA to protect state and
local public employees who take part in asbestos
abatement projects but are not protected by OSHA
regulations. The rule, which is similar to the current
OSHA asbestos standard, establishes a permissible
exposure level and requires use of certain work practices
during asbestos abatement. The rule, under section 6(d) of
TSCA, was immediately effective upon publication, and
will be made final after a public comment period in FY
1986.
During FY 1985, the Agency reviewed appropriateness
of action under TSCA to control risks associated with the
commercial manufacture and use of asbestos. The Agency
expects to decide on a course of action early in FY 1986.
In July 1985, EPA referred 4,4'-MDA to the Occupational
Safety and Health Administration (OSHA) for regulatory
consideration, based on the conclusion that this chemical
presents an unreasonable risk of cancer to workers. The
report describing this referral, issued under the authority
of section 9(a) (July 5, 1985 (50 FR 27674]) was the first
use of section 9 of TSCA. In exercising its referral
authority under section 9(a), EPA gave OSHA the first
opportunity to regulate workplace exposures to 4,4'-MDA.
About 98 percent of the 400 million pounds of 4,4'-MDA
produced in the United States each year is used to make
methylene diphenylene isocyanate (MDI), which is used,
in turn, to make polyurethane foams and elastomers. The
chemical is also used to make products such as epoxy
resins, wire coatings, and dyes. Workers can be exposed to
4,4'-MDA either by breathing it or by absorbing it through
the skin. Approximately 600 workers are exposed to the
chemical during its manufacture and conversion to MDI;
several thousand are exposed to non-MDI applications.
EPA will refer the chemical, 1,3-butadiene, to OSHA,
under the authority of section 9(a) of TSCA, for regulatory
consideration. This referral is based on EPA's conclusion
that exposure to the chemical presents an unreasonable
risk of cancer to workers. The report describing the referral
will be published in the Federal Register early in FY 1986.
1,3-Butadiene is an industrial chemical produced at a rate
of about 3 billion pounds per year in the U.S. and is
predominantly used as a. monomer in the production of
various types of synthetic rubbers, plastic, and resins.
1,3-Butadiene is a gas at ambient temperatures, and there
is a significant potential for human exposure via
inhalation of this chemical at the workplace. Worker
exposure may occur during manufacture of the monomer,
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Glycol Ethers
Metalworking
Fluids
4,4'-Methylenebis-
(2-chlorpben-
zenamine)
(MBOCA)
during processing into polymers, and during fabrication of
various products (e.g., tires) from the polymers.
The Agency has reviewed a number of surveys of air
concentrations of 1,3-butadiene to which workers are
exposed in plants that produce the monomer and in plants
that process it into various polymers. The data compiled
from various sources indicate that from 500 to 700 workers
in monomer production plants and from 4,800 to 7,500
workers in polymerization plants are exposed to
1,3-butadiene.
EPA, in a joint effort with the National Institute for
Occupational Safety and Health (NIOSH), is currently
assessing other occupational exposures to 1,3-butadiene,
such as in rubber tire manufacturing plants.
In FY 1984, EPA initiated a regulatory investigation under
section 6 to explore the need for, and feasibility of risk
management regulations for 2-ethoxyethanol,
2-methoxyethanol and their acetates (glycol ethers).
Studies indicate that the subject glycol ethers produce
adverse reproductive and developmental effects in animals
at low doses.
The Agency is considering referrals under section 9 to
either the Consumer Product Safety Commission and/or
the Occupational Safety and Health Administration, for
those agencies' consideration of possible new control
measures and/or controls pursuant to section 6 of TSCA. A
proposed section 6 rule and/or section 9 referral is
expected to be published during FY 1986.
In FY 1984, EPA initiated a regulatory investigation of
nitrosamines in metalworking fluids. Adding inorganic
nitrite corrosion inhibitors to metalworking fluids
containing amines results in the formation of nitrosamines,
particularly n-nitrosodiethanolamine (NDELA). Studies
indicate that NDELA is a potent animal carcinogen at
relatively low doses.
As a result of the investigation, EPA is concerned that
the intentional addition of inorganic nitrites to
water-containing metalworking fluids may present an
unreasonable risk of cancer to workers. The Agency is1
evaluating whether TSCA or the OSHA Act is the
appropriate regulatory authority. A proposed section 6 rule
or section 9 referral is expected to be published in the
spring of FY 1986.
On April 26, 1985, EPA proposed a significant new use
rule (50 FR 16519) under section 5 bf TSCA applicable to
any person intending to manufacture MBOCA in the U.S.
It would require prior EPA review of any such planned
manufacture. MBOCA, a demonstrated animal carcinogen,
28
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1,2,3,4,7,7-
Hexachloronor-
bornadiene
(Hex-BCH)
Methyl n-Butyl
Ketone (MBK)
Chemical
Advisories
is used as a curing agent in the manufacture of certain
polyurethane elastomeric articles. Significant human
exposure to this chemical can occur in manufacturing
facilities predominantly through dermal contact with
MBOCA dust. MBOCA is not now manufactured in the
U.S.; no OSHA standard exists for the chemical. EPA is
exploring regulatory options managing the risks associated
with commercial use of this chemical.
On February 22, 1985, EPA proposed an information
gathering rule for Hex-BCH (50 FR 7351). This rule would
require manufacturers, importers, and processors of
isodrin or endrin to submit a section 8(a) report to EPA.
All other manufacturers, importers, and processors of
Hex-BCH would be required to submit a section 5 (a)
significant new use notice. These reports and notices
would allow EPA to monitor the volume of Hex-BCH
manufactured, imported, and processed, the number of
individuals exposed to Hex-BCH, and the method of its
environmental release or disposal. EPA would evaluate the
reported information to determine if further regulatory
action is needed.
EPA drafted a proposed significant new use rule under
section 5 of TSCA applicable to manufacturers, importers,
and processors of MBK. This chemical is not currently
being manufactured, imported, or processed in the United
States. It has been used as a lacquer thinner, varnish
remover, and solvent. It is a known human neurotoxicant,
with effects noted in workers at facilities using MBK, as
well as in consumers exposed to the substance.
Chemical Advisories provide information to the public
about toxic effects of chemicals of concern, routes of
exposure, and alternative methods of reducing risks. They
are written by EPA's Office of Toxic Substances after
consultation with interested parties which include
companies, public interest: groups, and other agencies.
They are designed to be used where an increased
awareness of potential risk is likely to lead to meaningful
precautions, and are addressed and distributed to
individuals or organizations for whom the information is
most useful. Chemical Advisories are intended to
encourage voluntary risk-reduction actions by individuals
or organizations in instances where regulatory control is
not appropriate or as interim measures while regulatory
action is pursued.
In FY 1985, two Chemical Advisories (non-regulatory
informational documents) were issued. They addressed
hazards from p-tert-butyl benzole acid, and
4,4'-methylenebis(2-chloroaniline) (MBOCA). Another
29
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Chemical Advisory on burning used oil in space heating
equipment is currently under external review by other
interested agencies and is expected to be issued early in
FY 1986.
Manufacturers, processors, and importers who handle
p-tert-butyl benzoic acid and derivatives were advised to
minimize worker exposure to these chemicals. They have
been shown in laboratory tests to cause testicular effects in
rats and are suspected of causing these effects in humans.
Tests also indicate that these chemicals may also damage
the liver and kidney and cause central nervous system
effects. EPA recommended that workplace exposures be
monitored, airborne concentrations be controlled at the
source by enclosing the operation or process and using
local exhaust ventilation, and the use of protective
equipment or clothing by workers where direct contact
with the chemicals cannot be avoided.
For 4,4'-methylenebis(2-chloroaniline), also known as
MBOGA, manufacturers of pplyurethane products who use
this chemical were advised to minimize worker exposures
to it. MBOCA has been demonstrated to cause cancer in
laboratory animals. Workers can be exposed to MBOCA
primarily through skin contact and, to a lesser extent,
through inhalation or ingestion of MBOCA dust particles.
Engineering controls were recommended, such as
enclosing processes that use MBOCA and replacing
manual transfer of the substance with automated systems.
Other suggested controls included consideration of a glove
box installation or the use of a specialized ventilation
hood.
Another Chemical Advisory addresses the problem of
potential exposure to lead and other combustion products
from improperly vented oil burners. The concern is for
small workplaces where used motor oils containing lead
are burned as fuel in heaters. The Advisory will be
distributed in early FY 1986 to complement a proposed
rule by the Office of Solid Waste under the Resource
Conservation and Recovery Act (RCRA). When final, that
rule will ban burning used oil in unvented space heaters.
Prior to publication of the final rule, the Advisory will
alert those people who burn used oil of the hazard, along
with notifying them of the planned regulation.
30
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5
Chemical Testing
Program Section 4 of TSCA gives EPA the authority to require by
Status ru^e tna* manufacturers and processors of chemicals test
for certain health and/or environmental effects. A test rule
specifies the chemical to be tested, health and
environmental effects for which testing is required, test
standards, schedules for submission of the test data, and
who is responsible for conducting the testing. The Agency
requires testing where existing data are insufficient to
determine or predict effects. Data obtained through testing
are used by EPA and others to determine whether and
how to regulate or control potentially hazardous
substances.
An Interagency Testing Committee (ITC) was established
by section 4 to review available data on chemicals in
commerce and to recommend chemicals for priority testing
consideration by EPA. From these recommendations, the
ITC designates those chemicals to which the EPA should
respond within 12 months. The ITC can also recommend
chemicals without designating them. The ITC's list of
designations is limited to 50 chemical substances and
mixtures at any one time. Under the Act, the Committee
must consider revising its list, and report to the EPA at
least every six months. TSCA requires EPA to respond to
chemical designations within one year by either initiating
rulemaking to require testing of each designated chemical,
or by determining there is no need to test and publishing
the reasons for not testing.
As part of developing test rules, EPA is required
annually to develop and review test standards and
guidelines for a wide variety of health and environmental
effects. EPA develops generic test guidelines which then
become the basis for chemical-specific test standards cited
in the rules (47 FR 13012). These EPA guidelines and
certain Organization for Economic Cooperation and
Development (OECD) guidelines were published in the
Federal Register (50 FR 39252 and 50 FR 39472,
respectively) and subsequently will be codified in the
Code of Federal Regulations. As each new guideline is
developed, scientists from other EPA program offices
review the guidelines to ensure that they are consistent
and reflect the most current and valid testing practices. It
is then submitted to peerreview by scientists and experts
from outside the Agency in the academic community,
31
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State and Federal agencies, public interest groups, and
industry. In addition, an annual review of the published
guidelines is carried out and, where warranted, the
guidelines are updated.
In FY 1985, EPA took a total of 21 ITC-relate.d. actions. .
Eight of these were responses to new ITC designations, 11
were post-initial response determinations, and 2 were
actions on chemicals recommended, but not designated by
the ITC. These produced 10 decisions not to test; 2
ANPRs; 6 proposed rules; and 3 final rules. Table 4 shows
FY 1985 actions taken on ITC designated and
recommended chemicals.
During FY 1985, EPA developed four new, and updated
two testing guidelines for publication. Thirty-eight
chemical specific test standards were produced in support
of proposed test rules.
Table 4
Responses to Interagency Testing Committee (ITC)
Designations
Date
Chemical
Action
ITC List
11/19/84
11/19/84
11/19/84
2-(2-Butoxyethpxy)-
ethyl Acetate
Advance i\otice 01 froposed Rulemaking;
expands scope of Rulemaking to include
diethylene glycol butyl ether, defines testing EPA
is considering for both chemicals, and seeks
public comment on fiPA's plan to propose a test
rule for these two chemicals.
Ethylene Bis- Decision Not to Test; sufficient data are available
(oxyethylene) Diacetate to determine or predict the effects on human
health under under current conditions of
manufacture and use.
1,2,3,4,7,7-Hexachloro- Decision Not to Test; the present limited
norboraadiene manufacture and controlled disposal of this
chemical is not expected to cause substantial or
significant human exposure or present an
unreasonable risk to human health or the
environment.
11/19/84 Oleylamine
12/28/84 Chlorobenzenes
01/30/85 Phenylenediamines
Notice of Proposed Rulemaking; to perform
testing for health effects including developmental
toxicity, dermal subchronic toxicity, and
mutagenicity.
Decision Not to Test; to withdraw structural
teratogenicity and subchronic effects testing of
mpnochlorobenzene, ortho-dichlorobenzene,.
pora-dichlorobenzene and 1,2,4-trichlorobenzene;
and oncogenieity andreproductive effects testing
of pentachlofobenzene, based on sufficient
availability of'data to reasonably predict low risk
at anticipated exposure levels.
Decision Not to Testj 34 of 47 PDA category
members were not believed to warrant testing
because of low, or no, production.
13
13
13
13
3?:
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Date
Chemical
Action
ITCList
05/03/85 Isppropyl Biphenyl/
Diisopropyl Biphenyl
05/17/85 Bisphenol A
05/07/85 Chloromethane
05/08/852 l,2-Dibromo-4-
(1,2-dibromoethyl)
Cyclohexane
05/17/85 2-Ethylhexanoic Acid
05/17/85 Ethyltoluene/Trimethyl
benzene (Cg, fraction)
05/23/85 Diethylenetriamine
05/23/86 Diethylenetriamine
08/07/85 1,1,1-Trichloroethane
09/06/85 Benzyl Butyl Phthalate
09/06/85 Alkyl Ejpoxides
09/12/85 Biphenyl
10/03/85 2-Chlorotoluene
11/19/84 DiethyleneQlycol i&utyl
Ether
07/22/85 Carbofuran
Intermediates
33
Decision Not to Test; based on limited exposure 14
to these chemicals during their manufacture,
processing, and use, there is neither significant
human exposure to them nor reason to believe
that there may be an unreasonable risk to human
health or the environment.
Notice of Proposed Rulemaking; to perform 14
health and environmental effects testing
including inhalation subchronic toxicity, and
acute and chronic aquatic toxicity testing.
Decision Not to Test; to withdraw oncogenicity 1
and structural teratogenicity testing. Notice also
discusses availability of information on
chloromethane's reproductive and mutagenic
potential.
Decision Not to Test; sufficient available data 14
indicate that few people are exposed and then at
very low levels.
Notice of Proposed Rulemaking; to perform 14
health effects testing including phannaco-kinetic
studies, subchronic toxicity ana developmental
toxicity tests.
- Notice of Final Rulemaking; to test the Cs, 10
aromatic hydrocarbon fraction for neurotoxicity,
mutagenicity, developmental toxicity,
reproductive effects, and oncogenicity.
Notice of Proposed Rulemaking; to conduct 8
chronic oncogenicity bioassays.
Notice of Final Rulemaking; to perform testing 8
including oral subchronic toxicity, dermal
absorption, chemical fate and iputagenicity.
Notice of Proposed Rulemaking; to propose that 2
the protocols and schedule submitted by an
industry consortium be adopted as the test
standards to be used to test this chemical for
developmentally toxic effects.
Notice of Proposed Rulemaking; to require certain 7
environmental fate and effects testing.
Decision Not to Test; existing information on 1
health effects does not suggest an unreasonable
risk at expected exposure levels.
Notice of Final Rulemaking; to perform testing for 10
environmental effects and chemical fate
according to protocols submitted to and approved
by EPA.
Decision Not to Test; data received from a 8
Negotiated Testing Agreement were adequate to
support determination that this chemical does
not pose risk to health and the environment.
Advance Notice of Proposed Rulemaking; EPA 13
proposes to include this non-designated chemical
with the Advance Notice of Proposed Rulemaking
for ITC designated chemical
2-(2-Butoxyethoxy)ethyl acetate, and defines the
testing EPA is considering to propose.
Decision Not to Test; EPA does not believe there 11
is a basis to find that these substances may
present unreasonable risk to the environment.
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Streamlining
Test
Rulemaking
Single-Phase
Rulemaking
In order to accelerate the testing of chemicals
recommended or designated by the ITC, the Agency had
developed the approach of negotiating testing agreements
(NTAs) with industry, where possible. This system was
pursued in lieu of the more lengthy regulatory test
rulemaking process. In August 1984, however, in a suit
brought by the Natural Resources Defense Council (NRDC)
(NRDC vs. US EPA, 595 F. Supp. 1255, S.D.N.Y. 1984), a
U.S. District Court issued a decision which found that
NTAs were not sanctioned under TSCA. Accordingly, EPA
has since reevaluated its section 4 testing program to find
other approaches to streamlining its rulemaking process
for testing.
On May 17, 1985, EPA amended its procedural rule
describing a two-phase rulemaking process used to
develop certain test rules under section 4(a) of TSCA.
Under the previous two-phase process, the first phase
states testing requirements and solicits proposed test study
plans; the second phase adopts a final test study program
and specifies the schedule for submission of data. Testing
can not begin until the second phase is promulgated. The
amended rule establishes an alternative single-phase
rulemaking process that the Agency will use in most cases
to expedite the development of test rules and to grant
exemptions from those test rules. Under the single-phase
process, EPA will propose the pertinent test guidelines or
other suitable test guidelines as the required test standard
in the initial notice of proposed rulemaking. The Agency
will also propose time frames for the submission of the
test data in the initial notice. In the final rule, EPA may
promulgate as the test standard either the previously
proposed test guidelines, a modified version, an
alternative methodology submitted by commenters, or a
modification of an alternative methodology.
This single-phase approach offers a number of
advantages over the t^yo-phase approach. First, the Agency
believes that the single-phase approach will shorten the
rulemaking period and expedite initiation of the required
testing. Secondly, this process will eliminate the
requirement for industry to submit test protocols for
approval, while allowing commenters to submit alternative
test methodologies during the comment period. Thus, it
preserves the flexibility of the two-phase process, but at
reduced administrative cost.
EPA will use the two-phase process, however, when no
well-accepted test methodology is available for inclusion
in the proposed test rule. Under such circumstances, the
two-phase process is expected to be the more expeditious
route to developing a final rule.
34
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Use-Based A pilot study was initiated in FY 1985 on an alternative
Cluster priority-setting strategy associated with test rule
Analysis development activities. The strategy involves a "use-based
clustering" approach, which refers to a way of grouping
chemicals based on common function and market
application characteristics. In general, use-based cluster
approaches would accomplish three things: (1) promote
consistent analysis of chemicals that substitute for each
other in use, (2) focus resources on chemical uses that
pose the greatest aggregate risk, and (3) reduce repetition
of analysis and regulatory initiatives, while permitting a
broad view of use/industry groups that incur large
collective burdens over time. Application of this strategy
to the test rules process would ensure that the chemical
selection and data development process for section 4 is
better integrated with risk assessment and risk
management activities in the OTS existing chemicals
program. Two chemicals were selected from the ITC's 15th
and 16th reports for the pilot study. A preliminary
analysis was made to identify substitutes for the
designated chemicals in those uses where exposure is
significant. Chemical screening is currently proceeding.
Quality Of In addition to test rulemaking, guidelines, and
Data chemical-specific standards, EPA pursues a rigorous
program to ensure the quality of data received as a result
of chemical testing. In FY 1984, the Agency promulgated
Good Laboratory Practices (GLP) standards (48 FR
53922-53944, November 29, 1983]. These established
procedures for conducting health effects and
environmental effects testing under TSCA; and
requirements for facility operation, maintenance of
equipment and recordkeeping.
To ensure compliance with these GLP standards and
with testing requirements under TSCA and FIFRA, EPA's
Office of Compliance Monitoring within the Office of
Pesticides and Toxic Substances is responsible for
conducting laboratory inspections and auditing completed
test studies. Inspection staffs are drawn from EPA
headquarters, Regional Offices, and from the Food and
Drug Administration (FDA). OTS provides scientific and
technical support to the Office of Compliance Monitoring
through its Health and Environmental Studies Audit
Program (HESAP). HESAP staff participate in laboratory
inspections and review test data resulting from ongoing
industry testing and test rules. Inspection and study audit
reports from EPA Regional Offices and the FDA are
received and reviewed and regulatory actions
recommended as appropriate.
35
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In FY 1985, 20 laboratory inspections were conducted
and 122 test studies were audited. See Chapter 6 for
specifics on compliance and enforcement actions.
36
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6
Compliance and Enforcement
Program
Actions
Compliance
Actions
EPA has developed specific strategies to enforce
regulations under TSCA. These strategies identify and rank
possible violations, identify the available tools for
compliance monitoring, specify how these tools are to be
used, and provide a formula to determine the application
of inspection resources. Where inspections uncover
violations of TSCA requirements, EPA levies civil
penalties and, as appropriate, criminal penalties, as
authorized by section 16 of TSCA.
During FY 1985, EPA developed and issued a compliance
monitoring strategy for the section 6 Asbestos Abatement
Projects Rule. EPA also developed and issued an
enforcement response policy for TSCA Good Laboratory
Practices (GLP), and revised the enforcement response
policies for TSCA sections 5 and 8(a), and the section 6
asbestos-in-schools rule.
EPA continued its five cooperative enforcement
agreement programs to monitor compliance with the PCB
regulations in the States of Connecticut, Maryland,
Michigan, and Ohio and to conduct compliance monitoring
activities concerning the presence of asbestos-in-schools in
the State of California. During FY 1985, these States
conducted 463 PCB compliance inspections and 133
asbestos-in-schools inspections at local education agencies.
During the latter part of FY 1985, EPA entered into
cooperative enforcement agreements with 10 additional
States to initiate 4 PCB and 8 asbestos-in-schools
compliance inspection programs.
During FY 1985, EPA conducted a broad range of
inspections for TSCA requirements. The EPA along with 4
state agencies cooperating under the terms of enforcement
grants-in-aid conducted 2,079 PCB compliance monitoring
inspections. In addition, the Agency, operating under a
cooperative agreement with the American Association of
Retired Persons and the State of California, conducted
2,147 asbestos-in-schools inspections. The Agency also
initiated the initial inspections under the Asbestos
Abatement Projects Rule and conducted 5 inspections in
that area in FY 1985.
During FY 1985, the Agency also monitored compliance
with TSCA sections 4, 5, 8, and 13 requirements. EPA
37
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inspected 20 laboratories conducting testing under TSCA
to determine if the laboratories were in compliance with
GLP requirements. During these inspections EPA
conducted 122 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 800 inspections to
determine compliance with sections 5 and 8 requirements.
The Agency conducted a total of 586 inspections to
determine compliance with chemical import requirements.
In addition, the Agency also conducted 14 inspections to
monitor compliance with the ban on nonessential aerosol
uses of chlorofluorocarbons, and conducted 6 compliance
.inspections for the section 6 dioxin rule (45 FR 32686).
Civil Fiscal Year 1985 saw unprecedented enforcement activity
Enforcement under the Toxic Substances Control Act. The largest civil
Actions administrative penalty in the history of EPA was collected
this year. In addition, for the first time, full scale
environmental audits were included in Agency case
settlements. Among the most significant TSCA civil
administrative actions in 1985 were the following:
Chemical Waste Management — Emelle, Alabama. This
case represents one of the most comprehensive
enforcement actions ever undertaken by EPA. The
violations at this facility included illegal storage and
disposal of PCB-contaminated oil. The settlement included
an enforceable schedule for compliance activities, the first
comprehensive environmental audit included in an
Agency consent agreement, a hydrogeologic study of
groundwater, and payment of a cash penalty of $600,000.
Diamond Shamrock Corporation — Greens Bayou, Texas.
This enforcement action addressed violations which
included the illegal disposal of PCB-contaminated waste
at an unpermitted facility. The settlement, negotiated by
EPA Region 6 personnel, required environmental
management improvements, the development of new
operating procedures for handling and disposing of PCBs,
payment of an $800,000 cash penalty, and assessment of
stipulated penalties for non-compliance with the terms of
the consent agreement.
Diamond Shamrock Chemicals Corporation — Irving,
Texas. In this action, Diamond Shamrock was charged
with violations of TSCA section 5 premanufacture
notification requirements for new chemicals. Under the
terms of this settlement, the company paid a civil penalty
of $900,000, the highest single penalty ever collected
under TSCA section 5, and agreed to perform
38;
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comprehensive TSCA compliance audits at 43 of its
facilities nationwide.
Chemical Waste Management — Vickery, Ohio. This
settlement, negotiated by EPA Region 5 staff, concerned
TSCA and RCRA violations. These violations included the
illegal sale and distribution in commerce of over 6,000,000
gallons of PCB-contaminated waste oils. The settlement
required the suspension of additional waste receipts at the
facility for a period of 10 months, construction of a toxic
chemical waste landfill, implementation of a
comprehensive groundwater monitoring program, an
environmental management audit, and the payment of a
civil penalty in the sum of $2,500,000. This is the largest
civil administrative penalty ever collected in the history of
EPA.
Commonwealth Edison Corporation — Chicago, Illinois.
This settlement, negotiated in January, 1985, by Region 5
staff, settled an administrative penalty action involving
improperly disposed of PCBs, which have been spilled
from polemounted electrical capacitors. Edison
decontaminated each spill site, demonstrated the cleanup
levels through verification sampling and analysis, and
paid a civil penalty of $80,000, the largest penalty ever
paid by an electrical utility.
In addition to the above enforcement actions brought in
FY 1985, the Agency also undertook four enforcement
initiatives in areas of high priority to the toxics program.
In June, EPA simultaneously filed six civil
administrative complaints under TSCA's PMN
requirements seeking penalties ranging from $6,000 to $3.7
million. The simultaneous filings of these actions by
Headquarters and by Region 5 were intended to promote
the visibility of the Agency's chemical assessment
program.
A similar effort followed in July with respect to TSCA
reporting requirements. As part of a
Headquarters-coordinated effort, EPA regional personnel
filed administrative cases assessing civil penalties totaling
$160,000 against seven companies for reporting violations.
Six of these cases concern major violations of the
reporting requirements with respect to commercial and
industrial uses of asbestos. These were the first such cases
ever brought by EPA concerning asbestos reporting under
TSCA. A seventh case involved failure to file a required
report on an imported chemical.
The Agency followed with two additional enforcement
initiatives in September 1985, both undertaken by Region
2 attorneys. First, the Region filed three civil
administrative actions under TSCA seeking total penalties
39
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Table 5
of $75,000. Section 4, a test rule, requires manufacturers to
submit notices of intent to test shipments of certain
chemicals or to submit an application for exemption from
the test rule at the time of manufacture. These cases
represented the first EPA enforcement actions ever taken
under TSCA section 4.
Also in September, Region 2 filed twelve administrative
complaints seeking total penalties of $90,000 for failure to
comply with the import certification requirements of
TSCA. This provision requires a chemical importer to
either certify the compliance of shipments with TSCA
requirements, or to declare that shipments are exempt
from TSCA requirements. These were the first enforcement
actions to be taken by the Agency for import violations.
As a.result of stepped up asbestos-in-schools
inspections, the Agency issued 443 civil complaints for
alleged violations of section 6 asbestos-in-schools
requirements. The Agency also issued 253 civil complaints
this fiscal year as a result of PCB inspections. For the first
time under TSCA, 8 civil complaints were issued to
violators of section 8(a), 12 civil complaints to violators of
section 13, and 3 civil complaints were issued for
violations of section 4. In addition, EPA issued 1 civil
complaint for alleged violation of section 3(e) and 13 civil
complaints for violations of section 5. Figures for each
EPA Regional Office and Headquarters appear in Table 5.
Administrative Civil Actions Taken Under Section 16 of
TSCA, Complaints Issued, Cases Completed, and Amounts
Assessed (by Regions)*
Region Total No. No.
Complaints Complaints
Issued Issued
FY'79-85 FY'85
Total No. No. Cases Total No. Total Civil Total Penalties
Cases Completed of Cases Penalties (In $)
Completed In Pending Collected Collected
FY'79-85 FY'85** ($) In FY'85 FY'79-85
1
2
3
4
5
6
7
8
9
10
HQ.
TOTAL
79
240
132
150
453
158
185
130
85
82
23
1,717
50
98
51
83
167
44
102
55
:32
45
6
733
41
156
94
114
314
104
120
79
52
43
17
1,134
23
68
48
79
130
20
60
26
21
23
7
505
*A11 actions taken involved alleged violations of sections 4, 5, 6, 8,
**Includes cases carried over from FY 1980 - FY 1984.
38
84
38
36
139
54
65
51
33
39
6
583
4,5,
92,609
79,365
114,650
70,150
2,630,050
71,550
139,175
8,900
100,750
38,490
900,000
4,245,689
6, 8, and 13.
350,231
1,773,785
541,135
391,672
4,434,389
1,344,465
388,655
401,515
501,125
149,140
1,794,750
12,070,862
40.
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7
Litigation
Environmental Defense Fund, Inc. v. Environmental
Protection Agency (No. 791580, B.C. Cir.)
In 1979, the Environmental Defense Fund (EOF) petitioned
for review of EPA's regulations under TSCA sections
6(e)(2) and (3) governing the manufacture, processing,
distribution, and use of polychlorinated biphenyls (PCBs).
A decision largely in EDF's favor was issued on October 30,
1980. This decision and its aftermath were described
in reports for previous years. As a result of the Court's
orders in this case, EPA has 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. The
development for fiscal year 1985 in this case and related
rulemakings are described below.
Last year's report discussed the litigation and progress
in settlement negotiations involving the August 1982,
electrical equipment rule. Early in FY 1984, EPA entered
into two separate agreements whereby parties who had
filed petitions for review agreed to dismiss their suits if
the Agency would conduct two additional PCB rulemaking
proceedings within agreed upon time limits. EPA has
completed both rules. In November 1984, EPA issued a
regulation amending the PCB rule by modifying the
definition of "significant exposure" and presenting the
Agency's current framework for assessing PCB exposures.
EPA also issued a regulation in July 1985, amending the
PCB rule by placing restrictions and conditions on the use
of PCB transformers. The July 1985 rule has generated
another lawsuit. A petition for review was filed by
Mississippi Power Company in the Fifth Circuit.
A petition for review of the October 1982 rule was filed
by the Chemical Manufacturers Association (CMA) in
December 1982. By agreement of the parties, approved by
the Court, this petition was stayed pending further PCB
rulemaking. No further action has been taken on this
petition to date.
41
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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 has since been transferred to the D.C. Circuit
where the Court consolidated both cases. Settlement
discussions are proceeding.
Madison Metropolitan Sewerage District vs.
Environmental Protection Agency, (No. 85 Civ. 4605 W.D.
Wisconsin)
On May 23, 1985, plaintiffs in this case challenged the
refusal of the Region 5 Administrator to authorize
immediate disposal of PCB contaminated municipal sludge
on agricultural lands. Under the PCB regulations (40 CFR
761.60(a)(5}), EPA can approve an alternative disposal
method for disposing of municipal sewage if certain
findings are made. Plaintiffs contend that EPA's denial of
its application was: (1) arbitrary, capricious, an abuse of
discretion and not if) accordance with law; and (2)
unsupported by substantial evidence in the record.
On July 24, 1985, EPA filed.ajnotion to dismiss the
complaint on the grounds that plaintiff failed to exhaust
administrative remedies and for lack of jurisdiction.
The court issued a decision in EPA's favor on September
13, 1985.
N.O.C., Inc., fa Noble Oil Company v. Administrator, (No.
85-3175 3rd Cir.J
Noble Oil Company seeks review of a final order by the
Administrator assessing a civil penalty of $40,000 for three
separate violations of the regulations concerning disposal,
marking, and storage of PCBs.
Respondent argues, among other things, that: (1) the PCB
regulations were unenforceable because they were
invalidated by the D.C. Circuit in 1979; (2) the
Administrator's decision is not supported by substantial
evidence; and (3) the Administrator abused his discretion
by assessing the $40,000 civil penalty against Noble for 3
separate violations.
Briefs have been filed and oral arguments are expected
during fiscal year 1986.
42
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Service Employees International Union (SEIU) v.
Ruckelshaus, (No. 84-2790, D.D.C.)
SEIU brought this action in September 1984 to require
EPA to issue Federal regulations setting standards for
determining when an asbestos hazard requiring correction
exists in schools and other public and commercial
buildings, requirements for abatement activities where
such hazards exist, and standards for performing
abatement activities, including standards for the protection
of persons performing abatement.
In early proceedings SEIU asked the Court for a
preliminary injunction, arguing that EPA had a mandatory
duty to issue such rules based on promises made by the
Agency in response to citizens' petitions. Alternatively,
SEIU argued that EPA had failed to complete rulemaking
actions on asbestos hazards in a reasonable time.
On November 16, 1984, the Court denied the
preliminary injunction because EPA was "actively
pursuing new approaches for asbestos abatement," and
because EPA has in place a voluntary/regulatory asbestos
program. Further, the Court determined that deference to
EPA was appropriate, citing EPA's assurances that it
would shortly issue a final decision on the most feasible
asbestos regulatory approach.
November 30, 1984, EPA issued a final decision with
respect to certain parts of SEIU's request, stating that it
would not issue regulations governing decisions affecting
asbestos abatement activities because such decisions are
best made at the local level and the Agency's current
program and planned improvements should adequately
deal with the problem. EPA, however, continued with
rulemaking efforts related to protection of workers
conducting abatement activities and protection of building
occupants during abatement. Activities in this areas are
discussed elsewhere in this report.
SEIU amended its complaint, asking the Court to reverse
EPA's decision not to issue some of the regulations
requested, claiming that EPA's program is not adequate to
deal with the asbestos hazard in schools and other
buildings.
By the end of FY 1985, SEIU and EPA had filed written
arguments supporting their respective positions. A hearing
before the Court on pending motions has been scheduled
for early FY 1986.
43
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Natural Resources Defense Council (NRDC) and National
Wildlife Federation (NWF) v. Thomas (No. 85-0973,
D.D.C) x
Plaintiffs brought this action after EPA had denied, in part,
their 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.
By the end of FY 1985 a schedule for the filing of
motions was established.
Polaroid Corporation v. United States Environmental
Protection Agency and William M. Ruckelshaus (No.
84-3134-K, D. Mass.)
In October 1984, Polaroid Corporation (Polaroid)
challenged EPA's disclosure and handling of information
submitted by Polaroid under TSCA which had been
claimed as confidential business information under section
14 of TSCA and EPA's confidentiality regulations in 40
CFR Part 2. Polaroid challenged EPA making disclosures
of such confidential business information to certain EPA
contractors and subcontractors, other Federal agencies, and
certain arms of Congress and challenged the adequacy of
EPA's security and handling of such information. Further,
Polaroid alleged that some of EPA's actions violated the
settlement of a previous Polaroid suit involving
confidentiality issues in 1978 (Polaroid Corp. v. Costle
78-1133S, D. Mass.). Polaroid sought declarative and
injunctive relief.
Polaroid requested and was granted expedited discovery
which focused primarily on EPA's physical handling and
security of confidential business information under the
procedures in EPA's "TSCA Confidential Business
Information Security Manual" and the related manual
"Contractor Requirements for the Control and Security of
TSCA Confidential Business Information." In January
1985, Polaroid unsuccessfully sought a temporary
restraining order which would have severely constrained
EPA's review of certain premanufacture notices submitted
by Polaroid under section 5 of TSCA.
After further discovery, EPA and Polaroid entered
settlement negotiations which resulted in the District
Court entering a Consent Order. The Consent Order
addresses two areas. First, EPA was in the process,
44
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separate from this litigation, of making certain refinements
of its security procedures for handling and protecting
TSCA confidential business information, including
revisions of its security manuals. With respect to those
refinements, EPA agreed to report to the Court when they
were completed. Second, EPA and Polaroid identified
certain additional refinements in the course of settlement
discussions which EPA concluded would be worthwhile
to make. The Consent Order commits EPA to making those
additional refinements and reporting to the Court when
they are completed.
Several of the requirements of the Court Order have
already been met, and EPA anticipates that the remaining
requirements will be met by the end of FY 1986.
Chemical Manufacturers Association v. Environmental
Protection Agency (No. 84-1569, B.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 was promulgated on September 5,
1984 (49 FR 35011) and 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 EPA
proposed revisons to these procedural provisions. The
proposal of these revisions is likely to occur during the
first half of FY 1986.
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 that had denied a petition these same
groups had filed in April 1985, pursuant to section 21 of
TSCA. The April 1985 petition had requested that EPA
identify business entities in the southeast area of Chicago
which were releasing 11 named chemical substances into
the environment. The petitioners also requested that EPA
initiate rulemaking under TSCA section 4 (a) to require
these businesses to conduct a wide ranging set of testing
45
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on the identified chemical substances — including testing
of the substances for cumulative and antagonistic effects.
The Agency denied the section 21 petition, in part,
because there are no available test standards for studying
the cumulative effects of chemical substances. In addition,
EPA's denial notice indicated that health effects data on
the individual identified substances were adequate for
regulatory assessment. Finally, the notice stated that the
Illinois 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.
Plaintiffs' complaint asks the Court to order the Agency
to take the actions (described above) which EPA had
declined to take iii responding to the plaintiffs' TSCA
section 21 petition.
46
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8
International Activities
During FY 1985, EPA continued its international activities
to promote coordinated approaches to evaluating and
controlling toxic substances. These international activities
include the exchange of information and expertise. By
sharing its technical expertise and its broad experience in
chemical review and control, EPA provides a valuable
contribution to the several international programs.
One of its most important international efforts is
participation in the Chemicals Group and Management
Committee of the Organization for Economic Cooperation
and Development (OECD). The OECD, a 24-member
international organization composed of the world's major
industrialized nations, was founded to promote
development of and prevent barriers to international trade.
Due to a proliferation of national chemical laws during the
1970s, the OECD membership recognized the potential for
chemical trade barriers and established a program in 1977
to develop harmonized approaches to the review,
evaluation and control of toxic substances.
During FY 1985, EPA continued to play an active role in
the Chemicals Group and Management Committee. Several
important initiatives were launched and the first steps
were taken toward defining the framework for Chemicals
Group and Management Committee activities into the next
decade. In the area of existing chemicals, member states
agreed in October 1984 to establish, on a trial basis, a
Chemicals Information Switchboard, designed to increase
member state access to unpublished information on
chemicals. The Switchboard pilot, with six countries
including the United States, began operation on July 1
and, since that time, has received 11 queries and has
initiated 4. This could become an important mechanism
for international information sharing onichemicals.
Three early efforts in the Chemicals Program involved
hazard assessment, good laboratory practice (GLP) and
confidentiality of data. During the past year, important
new ground was broken for future work in these important
areas. With respect to hazard assessment, member states
convened in a special expert meeting in March 1985 and
arrived at a general consensus that work in environmental
exposure assessment should be started as a first priority.
The first workshop dealing with environmental exposure
assessment will convene in Vienna, Austria, in early 1986.
47
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In the area of good laboratory practice, the Chemicals
Group and Management Committee moved forward during
the past year on the basis of 1981 and 1983 GLP
recommendations. A meeting of GLP experts convened in
• February 1985 and agreed on major components of a work
program in this area. Member states later agreed that
information exchange was the most important program
element. Accordingly, it was decided to establish a regular
forum for national GLP administrators and experts to
exchange information and experience. The U.S. is ready to
conclude bilateral agreements on GLPs with several
countries and believes that these efforts could serve as a
model for other OECD member state agreements.
An expert group on confidentiality of data will convene
later this year in London to begin work on developing
model agreements for the exchange of confidential
information. This work will be based on three earlier
recommendations in this area concerning: principles to
govern the exchange of confidential information between
governments; a list of generally considered
non-confidential data; and measures for protecting
proprietary data.
Increasingly, EPA's attention and efforts will focus on
preparations for the third meeting of the Chemical Group
at High Level (called HLM). These HLMs occur
periodically to review work in the Chemicals Program and,
more importantly, to give guidance for the nature and
direction of future work.
Ongoing Chemicals Program activities of importance to
OTS are the Test Guidelines Updating Panel and the
Complementary Information Exchange Procedure. During
the past year in the Updating Panel, several new
guidelines in genetic toxicology were reviewed for
incorporation into the OECD Test Guidelines; and
revisions were proposed to an acute (eye irritation)
toxicology guideline. Ongoing, and increasing, concern for
animal welfare prompted the Secretariat to offer to host
an OECD meeting on this issue, scheduled for early spring
1986. Participants will consider primarily revisions to
existing acute toxicity guidelines, particularly the LD50
guideline.
The Complementary Information Exchange Procedure
was established in 1978 to provide member states early
notice of regulatory plans or actions. The U.S. has
historically sent more information through this system
than other member countries. However, as more and more
countries have legislation or regulatory action to report,
the system is being utilized to an increasing degree.
EPA also participates in several programs of the United
Nations, such as the United Nations Environment Program
48
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(UNEP), International Register of Potentially Toxic
Chemicals (IRPTC) and the World Health Organization
(WHO) International Program on Chemical Safety (IPCS).
The basic objective of the IRPTC is promoting more
efficient use of national and international resources in the
evaluation of chemicals. EPA supports IRPTC by providing
scientific and regulatory information on chemicals, and by
responding to chemical inquiries relayed through IRPTC
headquarters in Geneva.
In January, UNEP convened experts for the second time
to develop a UN-wide scheme for the exchange of
information related to banned or severely restricted
chemicals in international trade. The scheme, which
closely resembles EPA's existing export notification
procedures, was adopted on a provisional basis in May.
The IPCS was established in response to a recognized
need for a collaborative international approach to evaluate
the effects of chemicals on health and the environment.
Member state experts work within the IPCS to develop
assessment documents on chemicals, set exposure
guidelines, coordinate testing when appropriate, and
promote technical cooperation and training. EPA was a
co-sponsor, and chairman, of an international symposium
on hexachlorobenzene, which took place in Lyon, France
in June 1985, and also has assumed lead responsibility for
an assessment document on glycol ethers. In response to
the Bhopal tragedy, IPCS launched an effort for more
effective international response to such accidents. OTS is
participating in the first steps of this effort, which include
projects on reactive intermediates and identification of
national emergency response mechanisms and reporting of
incidents.
In addition to these multilateral international activities,
OTS engaged in bilateral activities with other governments
or organizations. Most recently, OTS had bilateral
consultations with the Commission of the European
Communities in Brussels. Agreement was reached for
future cooperation in the areas of existing chemicals,
biotechnology, hazard assessment and investigation of
formaldehyde.
49
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Appendix A
Major FY 1985
TSCA Acti
-------
Section Description
of Law
Date
Consent Order; Substituted aliphatic acid halide; substituted 10/12/84
hydroxylamine—requires the use of impervious gloves and protective
clothing by workers when handling either substance, as well as the use
of respirators when workers are exposed to vapors of substituted
aliphatic acid halide pending development of information. Wastes
resulting from production of substituted aliphatic acid halide must be
incinerated. Wastes resulting from production of substituted
hydroxylamine must be treated so that content is less than 10 ppm prior
to discharge.
Consent Order; Unsaturated aminoalkyl ester salt, unsaturated amino 10/30/84
ester salt—requires the Company to inform workers of the hazard and
provide labeling; requires workers to wear protective clothing, gloves
and goggles, pending development of information. In addition, controls
on use, commercial distribution; wastes and discharge, will be
implemented. The same controls are also required of contract
manufacturers.
Consent Order with Testing Trigger; Substituted aryl olefin, Substituted 11/15/84
alkyl arene—restricts the PMN substance to a maximum production
volume pending 90-day subchronic testing to address the health effects.
Consent Order: 12/04/84
Poly[l-oxo-l,6-hexanediyl)]-alpha-hydro-omega-hydroxy-, ester with
3-hydroxy-2,2-dimethylpropyl-3-hydroxy-2,2-dimethyl propanoate(2:l),
di-2-propanoate;
Poly[oxyfl-oxo-l,6-hexanediyl)]-alpha-(l-oxo-2-propenyl)-omega-
[(tetrahydro-2-furanyl)methoxy];
Poly[oxy(l-oxol,6-hexanediyl)]-alpha-hydro -omega-hydroxy-, ester with
2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-l)
3-propanediol]2-propenoate, 2-propanoate; 2-Propenoic acid,
[2-[l,l-dimethyl-2-
[(l-oxo-2-propenyl)oxy]ethyl]-5-ethyl-l,3-dioxane-5-yl]methyl ester;
(Imported)—requires the use of protective equipment in the form of
impervious gloves, safety goggles and protective clothing pending
development of information. In addition, the importer will only sell to
those who will process and use these substances in the same place.
Consent Order; Phosphonium salt—requires workers to wear protective 12/10/84
equipment.
Consent Order; Disubstituted nitrobenzene — requires workers to wear 12/27/84
protective equipment in the form of impervious gloves, goggles and
protective clothing when handling this substance pending aevelopment
of information.
Consent Order; Substituted aminobenzoic acid ester— requires 12/27/84
protective equipment in the form of impervious gloves, goggles, and
protective clothing pending development of information.
Consent Order; Polyaromatic urethane poly (unsaturated)ester—requires 01/15/85
appropriate protective equipment, notification letters, and labeling
pending development of information. Distribution of the PMN substance
is also limited.
Consent Order; Polyfunctional aziridine—requires protective equipment 01/28/85
in the form of impervious gloves, goggles, protective clothing and
respirators for workers pending development of information.
Consent Order; N-Dimethylthiocarbamylthio--N'-phenyl urea—requires 2/01/85
workers to wear gloves, protective clothing, and chemical safety goggles
pending development of information.
Consent Order; Methylammonium N-methyldithiocarbamate—requires 02/09/85
protective equipment pending development of information.
51
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tion Description
Date
law
Consent Order with Testing Trigger; Cfl-8 Carboxylic acid—includes a
production volume trigger, at which time the Company must submit
developmental toxicity data. The Order also requires gloves, notification
letters, labels, a Material Safety Data Sheet (MSDS) and standard
teratology testing to address teratogenicity concerns.
Consent Order; Epoxy ester—requires impervious gloves, protective
clothing and chemical safety goggles for workers pending development
of information.
Consent Order; Polychlorofluoro aromatic alkylated
hydrocarbon—requires the use of impervious gloves, a Material Safety
Data Sheet (MSDS) and a label that limits worker exposure pending
development of information.
Consent Order; 6-Nitro-2(3H)-benzoxazolone—requires workers to wear
protective equipment in the form of impervious gloves. .
Consent Order; 3-Alkyl-2-(2-anilino)vinyl thiazolinium salt—requires
the use of safety goggles, impervious gloves, and chemical respirators;
labeling, a notification letter with disposal and first aid procedures, and
certain restrictions on manufacture and distribution of the chemical
pending development of information.
Consent Order; N-N'-Bis(2-(2-(3-alkyl)vinyl)-l ,4-phenylenediamine
gles, glove
double salt—requires the use of goggles, gloves, chemical respirators,
labeling, a notification letter with disposal and first aid procedures, and
certain restrictions on manufacture and distribution of the chemical
pending development of information.
Consent Order; Polyurethane—limits worker exposure and requires
impervious gloves, safety goggles, protective clothing and respirators
pending development of information.
Consent Order with Testing Trigger: Alkyl ester—requires protective
gloves and labeling to control worker exposure and a testing trigger for a
90-day oral or inhalation subchronic study.
Consent Order; Polyurethane polymer—requires dermal protection,
warning labels, a letter, and Material Safety Data Sheet (MSDS)
notifying users of the requirements of the Order and the hazard
concerns pending development of information.
Consent Order; Alkylated diphenyl oxide—requires chemical safety
goggles, impervious gloves and protective clothing to control worker
exposure, pending a Chernoff screening test.
Consent Order; Urethane acrylate—requires the use of protective
equipment in the form of impervious gloves, safety goggles and
protective clothing pending development of information.
Consent Order with Testing Trigger; Alkyltrialkoxysilane—requires
chemical safety goggles, impervious gloves, respirators, protective
clothing and includes a testing trigger involving a 28-day repeated dose
inhalation study.
Consent Order; (1) Brominated arylamine— requires,protective
equipment for potentially exposed workers. In addition, the Order
restricts the physical form in which the PMN substance may be
distributed; (2) with Testing Trigger; Brominated aromatic—requires
protective equipment for potentially exposed workers. The Order also
includes a testing trigger involving a 90-day subchronic study, and
restricts the physical form in which some of the PMN substances will be
distributed; ana (3) with Testing Trigger; Brominated arylamine
amino—requires protective equipment for potentially exposed workers.
The Order includes a testing trigger involving a 90-day subchronic
study.
Consent Order with Testing Trigger; Brominated arylcarbonate—requires
protective equipment for potentially exposed workers. The Order
includes a testing trigger involving a 90-day subchronic study and a
second generation reproductive study. In addition, the physical form in
which the PMN substance will be distributed is restricted.
52
02/14/85
02/16/85
03/01/85
03/12/85
04/09/85
04/09/85
04/16/85
04/20/85
04/27/85
05/02/85
06/11/85
06/18/85
06/21/85
06/21/85
-------
Section Description
of Law
Date
Consent Order; Carboxylated alkane diol—requires personal protective 6/22/85
equipment to be worn to prevent exposure to the potential oncogen
pending development of information.
Consent Order; Methyl vinyl sulfone—requires protective equipment for 06/25/85
workers in the form of impervious gloves, safety goggles, and protective
clothing pending development of information.
Consent Order; Polysubstituted polyol—This is the first Consent Order 07/02/85
requiring processors to become co-signers of a PMN and the Order,
subject to its terms. These measures allow increased distribution of the
PMN substance pending the development of a Significant New Use Rule
(SNUR).
Consent Order; Polymer of hydroxyethyl acrylate, 4,4'-diphenylmethane 07/07/85
diisocyanate, and polymethylene polyphenyl isocyanate—requires use
of gloves, protective clothing over exposed body areas, chemical safety
goggles, respirators during spray operations, employee safety training
program, labeling^ and recordkeeping pending development of'information.
Consent Order; Acrylic ester—requires use of NIOSH-approved 07/12/85
respirators, protective clothing, chemical safety goggles, impervious
gloves, workers safety training programs, written warnings, and
recordkeeping.
Consent Order; Functionally modified urethane—requires use of gloves, 07/17/85
safety goggles and protective clothing, a respirator if spray application is
used, employee safety training programs, labeling and recorakeeping
pending development of information.
Consent Order with Testing Trigger; Polymer of hydrpxyjethyl acrylate
and polyisocyanate—requires gloves, goggles, protective clothing and a
respirator pending development of information.
Consent Order with Testing Trigger; Trisubstituted phenol—requires
gloves, goggles, protective clothing and a respirator pending
development of information.
Consent Order with Testing Trigger; Ester modified phenolic
resin—requires gloves, goggles, protective clothing and a respirator
pending development of information.
Consent Order; Benzenedisulfonic acid,
Chlorotriazinylarnino/dimethylphenylazoZsulfonaphthaleneazo
(Imported)—prohibits manufacture in the U.S., limits quantity of PMN
substances that can be imported, limits quantity sold to each customer
each year to no more than two persons who discharge effluent wastes
directly or indirectly into the same stream or river, and requires
recorakeeping.
Consent Order; Polymer of substituted aryl olefin; protective equipment
in the form of impervious gloves, goggles and protective equipment and
respirators.
Consent Order; Vinyl epoxy ester—requires protective equipment in the
form of impervious gloves, goggles and protective clothing.
5(h)(3) Premanufacture Notification; Proposed Revisions of Regulation
(Proposed Rule)
5(h)(4) Premanufacture Notification Exemptions; Exemptions of Polymers (Final
Rule)
Premanufacture Notification Exemptions; Exemption for Chemical
Substances Manufactured in quantities of 1,000 kg or Less Per Year
(Final Rule)
6(d) Asbestos Abatement Projects (Immediately Effective Proposed Rule)
6(e) PCBs: Modification of Definition of Totally Enclosed Manner for PCB
Activities (Final Rule)
PCBs: PCBs in Electrical Transformers (Final Rule)
PCBs: Proposed Incorporation by Reference Revision (Proposed Rule)
07/24/85
07/27/85
08/09/85
09/01/85
09/06/85
09/09/85
12/27/84
11/21/84
04/26/85
07/12/85
11/08/84
07/17/85
04/04/85
53
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Section Description
of Law
Date
PCBs: Response to Exemption Petitions (22) (Proposed Rule) 08/29/85
PCBs: Response to Ward Transformer Company Petition for Exemption 08/29/85
(Denial) (Final Rule)
8(a) Preliminary Assessment Information; Amendment to Include ' 11/05/84
3,4-Dichlorobenzotrifluoride from the 14th ITC List (Proposed Rule)
Reporting & Recordkeeping Requirements; Small Manufacturer 11/16/84
Exemption Standards (Final Rule)
Chemical Information Rule; Additional Automatic Reporting; 11/19/84
Amendment to the Preliminary Assessment Rule (Proposed Rule)
Preliminary Assessment Information; Amendment to Add Seven 11/28/84
Chemicals from the 15th ITC List (Final Rule)
Hexachloronorbornadiene; Proposed Submission of Notice of 02/22/85
Manufacture, Import, or Processing and Determination of Significant
New Use (Proposed Rule)
Partial Updating of TSCA Inventory Data Base; Production and Site 03/12/85
Reports (Proposed Rule)
Preliminary Assessment Information; Amendment to include • 03/25/85
3,4-Dichlorobenzotrifluoride from the 14th ITC List (Final Rule)
Preliminary Assessment Information; Amendment to include 05/03/85
Urea-Formaldehyde Resins (Final Rule)
Preliminary Assessment Information; Amendment to include Five 05/21/85
Chemicals from the 16th ITC List (Final Rule)
Chemical Information Rules; Additional Automatic Reporting (Final 08/28/85
Rule)
8(b) Chemical Substance Inventory; Intent to Remove 106 Incorrectly 05/07/85
Reported Chemical Substances from the TSCA Inventory (Proposed
Rule)
8(c) Records & Reports of Allegation of Significant Adverse Reactions to 12/24/84
Health or Environment; Clarification of Persons Subject to the Rule '
(Proposed Rule)
8(d) Health & Safety Data Reporting; Amendment to include 11/05/84
3,4-dichlorobenzotrifluoride from the 14th ITC List (Proposed Rule)
Health & Safety Data Reporting; Submission of Lists and Copies of 11/19/84
Health & Safety Studies (Proposed Rule)
Health & Safety Data Reporting; Amendment to add Seven Chemicals 11/28/84
from the 15th ITC List (Final Rule)
Health & Safety Data Reporting; Amendment to add 03/25/85
3,4-dichlorobenzotrifluoride from the 14th ITC List (Final Rule)
Health & Safety Data Reporting; Establishment of Termination Date 04/25/85
(Final Rule)
Health & Safety Data Reporting; Amendment to include 05/03/85
Urea-Formaldehyde Resins (Final Rule)
Health & Safety Data Reporting; Amendment to add Five Chemicals 05/21/85
from the 16th ITC List (Final Rule)
Submission of List and Copies of Health & Safety Studies on Vinyl 08/08/85
Acetate (Proposed Rule)
Health & Safety Data Reporting; Submission of Lists and Copies of 08/28/85
Studies (Final Rule)
Health & Safety Data Reporting Period Termination (sunset provision on 09/30/85
200 chemicals temporarily suspended) (Interim Final Rule)
Health & Safety Data Reporting Period Terminations (removal of 7 09/30/85
chemicals from list) (Final Rule)
Health & Safety Data Reporting; lengthening sunset provision on 250 09/30/85
chemicals (Proposed Rule)
54
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Section Description
of Law
Date
Submission of Lists of Copies of Health and Safety Studies in Certain 10/07/85
Substances Subject to the 1984 RCRA Amendments (33 chemicals)
(Proposed Rule)
9(a) 4,4'-Methylenedianiline; Decision to Report to the Occupational Safety 07/05/85
and Health Administration
12(b) Notification of Chemical Export; Applicability of Final Test Rule 11/19/84
(Statement of Clarification)
21 Denial of Citizens' Petition to Eliminate or Reduce Disposal and 10/31/84
Emissions of Toxic Substances into Environment of Southeast Chicago
from Multiple Polluting Sources.
Granted petition by the Natural Resources Defense Council, Inc., that 12/19/84
EPA Ban Use of Asbestos in Original Equipment and Replacement
Brakes for On-Road Cars and Trucks.
Partial Grant of Environmental Defense Fund and National Wildlife 01/30/85
Federation Citizens' Petition that EPA initiate multimedia investigation's
and research on dioxins and dibenzofurans. That EPA commence
regulatory action was denied.
Denial of Citizens for a Better Environment and Irondalers Against the 07/26/85
Chemical Threat Citizens' petition that EPA issue a rule under section 4
requiring the scientific testing of certain toxic chemical substances and
mixtures identified as pollutants in Southeast Chicago.
Chemical Advisories
Notice of Potential Risk, p-tert-Butyl Benzole Acid and Derivatives 03/85
Notice of Potential Risk, 4,4'-Methylenebis(2-chloroaniline) 06/85
v.
55
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Appendix B
Summary
Guide to
Information
Required by
Congress
' Sections 30, 28(c), and 9(d) of TSCA require that certain information be reported each year
to the President and Congress. To assist readers in locating this information, a summary of
each pertinent TSCA action and reference to a more detailed explanation found within
this report are given here.
Section 30. This section contains the basic requirementlor the Annual Report as tollows:
'< (1) Testing. In FT 1985, EPA published 10 decisions not to test, 2 ANPR's, 6 notices
of proposedl_rulemaking, and 3 final rules (see Table 4).
(2) Premanufacture Notices (PMNs). EPA received 1,478 PMN's during FY 1985
which brought the total received since the program's beginning in mid-1979, to
5,679. (None of these chemicals were subject to rulemaking under section 4.) In
FY 1985, 21 cases underwent voluntary testing or control activities, while 45
chemicals were subject to the development of either a section 5(e) or 5(f) order
(see Table 1).
(3) Rules Issued Under Section 6. During FY 1985 one immediately effective
proposed rule was published under section 6 regarding asbestos. This rule, to
protect state and local public employees not protected by current OSHA
regulations, establishes a permissible exposure level and requires use of certain
work practices during abatement activities (see Chapter 4, Existing Chemicals).
Five actions related to PCBs were issued in FY 1985. On November 8, 1984, a
final rule was published modifying the definition of "totally enclosed manner" to
more accurately reflect the Agency's framework for assessing PCB exposure. On
July 17, 1985, a final rule was published addressing fire-related risks associated
with PCBs in electrical transformers. On April 4, 1985, a proposed rule
incorporating by reference certain test methods to be used to meet particular PCB
testing requirements was published. On August 29,1985, a proposed rule was
published responding to 22 PCB exemption petitions. Also on August 29, 1985, a
notice of denial was published in response to a PCB petition for exemption (see'
Chapter 4, Existing Chemicals).
(4) Judicial Actions under TSCA and Administrative Actions under Section 16. '
Judicial actions involved PCBs, asbestos, dioxins, significant new use rules,
[EPA's testing program under section 4 of TSCA], section 21 citizens petitions,
and confidentiality of business information under section 14 of TSCA. Parts of
the PCB litigation are likely to be settled; two cases await decision. The asbestos
case is pending. Two suits were filed to compel EPA to regulate, one with
respect to dioxins and the other to require testing of certain chemical substances
present in the southeast area of Chicago; both are pending. A petition for review
was filed related to the first significant new use rule under section 5(a)(2);
briefing has been stayed pending further rulemaking. A suit was filed challenging
EPA's handling and disclosure of confidential business information; the case was
settled with a consent order that requires reporting of certain changes to EPA's
security procedures for handling such information'(see Chapter 7, Litigation).
A total of 733 civil enforcement complaints were issued in FY 1985. In
addition, there were 2 criminal and 6 civil referrals to the Department of Justice,
and 1,136 Notices of Noncompliance were issued (see Chapter 6, Compliance and
Enforcement).
(5) Major Problems in Administering the Act. No major problems were encountered
in FY 1985 in administering TSCA.
56.
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(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.
There were no grants administered under TSCA in FY 1985. Grants associated
with asbestos were administered under the authority of the Asbestos School
Hazard Abatement Act (ASHAA) (see Chapter 4, Existing Chemicals).
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 1985, EPA continued, in several formal and informal agreements
with other Federal government programs, to address specific chemical activities
with respect to the development and implementation of regulations under TSCA.
One of these continued efforts is participation in the Federal Asbestos Task
Force, of which OSHA, the CPSC and EPA are charter members. Other members
include the Food and Drug Administration, the National Institute of
Occupational Safety and Health, National Institute of Environmental Health
Sciences, and the National Cancer Institute.
In FY 1985, under an interagency agreement, EPA and NIOSH continued work
on developing occupational exposure assessments on 1,3-butadiene,
methylenebis(2-chlorobenzenamine) (MBOCA), acrylamide, and
4,4'-methylenedianiline, and control technology assessments on 1,3-butadiene
and MBOCA. The purpose of this agreement is to use the occupational expertise
of NIOSH in EPA's assessment program.
In FY 1985, the Agency was instrumental in forming an inter-agency group to
examine high-priority solvents of concern not only to EPA, but also to other
regulatory agencies. The workgroup examines solvents from a scientific policy
standpoint in order to develop a coherent position in regulatory strategy
development for the Federal government.
EPA is currently reviewing draft memoranda of agreement with OSHA and
CPSC to ensure that chemical problems are handled expeditioUsly under the
most appropriate authority. One chemical, 4,4'-methylenedianiline, was referred
to OSHA for regulatory consideration. Another chemical, 1,'3-butadiene, to be
referred to OSHA, is undergoing final review.
The Agency"continued to participate during FY 1985 on the Working Group on
Biotechnology, established-by-.the_Cabinet Council on National Resources and the
Environment. The group discussesTnajcuvFederal interagency issues on
biotechnology and develops a coordinated p6sitk>n..Q_n them. A joint statement
was prepared by the Office of Science and TechnologyTolicy, Food and Drug
Administration, and the Department of Agriculture, and was published in
December 1984. A final policy statement will be published in FY 1986.
The Agency continued its participation in an interagency agreement with the
U.S. Army for a compilation of methods for estimating physicochemical
properties of inorganic chemicals and metallo-organics. This project will enhance
current capabilities used routinely for estimating properties of PMN chemicals.
In an interagency agreement with the National Bureau of Standards
(Department of Commerce), a study was conducted to assess the state of fire
toxicology, evaluate fire hazard models in use, and develop written guidelines for
applying these methods to commercial use. Another study provides OTS with data
on exposure to formaldehyde in an occupational setting, the plywood and textile
industry.
Chemical Advisories are coordinated with other Federal agencies as
appropriate.
57
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Appendix C
Appendix D
Section 4 Test
Studies*
Received
Acrylamide
4-Chlorob"enzotrifluoride
2-Chlorotoluene
Methyl Isobutyl Ketone/Methyl Ethyl Ketone
Isophorone
4-(l ,1,3,3-Tetramethylbutyl)phenol
Tris(2-ethylhexyl) Trimellitate
Bis(2-ethylhexyl) Terephthalate
Alkyl Phthalates
Chlorinated Paraffins
Dichloromethane
1,3-Dioxolane
Oleylamine
Formamide
2-Phenoxyethanol
Aryl Phosphates
Propylene Oxide
Bisphenol A
Sodium N-Methyl-N-oleoyltaurine
*102 studies on 38 chemicals
Summary of
NTP Studies
National
Toxicology
Program (NTP)
Studies*
Reviewed
Dichloromethane
o-Phenylphenol
4-Vinylcyclohexene
N-Butyl chloride
Chlorendic Acid
Tetrachloroethylene
Ephedrine Sulfate
8-Hydroxyquinoline
CI Basic Red 9 Monohydrochloride
Dimethyl Morpholinophosphoramidate
Decabromodiphenyl Oxide
CI Disperse Blue
HC Red No. 3
Sodium Hypochlorite Phosphate
Chlorinated Paraffins (C23, 40% CI)
Chlorinated Paraffins (Ci2, 58% CI)
•16 studies on 16 chemicals
58
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Appendix E
Chemical
Hazard
Information
Profiles
(CHIPs)
Methyl bromide (update) 02/20/85
Phenylethanol 05/17/85
Phthalimide 07/03/85
Dimethoxyethyl Phthalate 07/22/84
Triethyl Phosphate 07/29/85
Dimethyl Hydrogen Phosphite 08/14/85
Nonylphenol 09/17/85
Vinylcyclohexene 09/19/85
Chloromethylpropene 09/19/85
Tri(alkyl/alkoxy)phosphates
(4 Chemicals) 09/23/85
Dichloro-2-butene 09/26/85
Triphenyl Phosphite 09/27/85
DDE Resin 09/30/85
Substitute
Hazard Profiles
Asbestos:
Aramid fibers
Polytetrafluoroethylene
Polyethylene
Polypropylene
Polyester
Ductile Iron Pipe
Metalworking Fluids:
Adipic Acid
Caprylic Acid
Azelaic Acid
Sebacic Acid
Dodecanedioic Acid
Stearic Acid
Mixtures of Cn, Ci2
Carboxylic Acids
Formaldehyde - Wood Uses:
Methylene Diphenylene
Diisocyanate (MDI)
Poly (MDI)
Phenol
Phenol Formaldehyde Resin
Ammonia
Methylene Chloride:
l,l,2-Trichloro-l,2,2-
trifluoroethane
Trichloroethylene
Tetrachlofoethylene
Carbon tetrachloride
1,1,1-Trichloroethane
11/02/84
11/02/84
11/02/84
11/02/84
11/02/84
11/02/84
02/08/85
02/08/85
02/08/85
02/08/85
02/08/85
02/08/85
02/08/85
06/11/85
06/11/85
06/11/85
06/11/85
06/11/85
09/26/85
09/26/85
09/26/85
09/26/85
09/26/85
59
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Appendix F
FY1985
section 21
Citizens'
Petitions
Date
Filed
Who
Filed
What Action
Requested
EPA's Date of
Disposition Disposition
07/17/84
09/11/8
10/22/84
4/23/85
Citizens for a
Better
Environment
and Irondalers
Against the
Chemical Threat
Natural
Resources
Defense
Council, Inc.
Environmental
Defense Fund
and National
Wildlife
Federation
Citizens for a
Better
Environment
and Irondalers
Against the
Chemical Threat
That EPA issue a rule to:
1. Clean up the Southeast section of
Chicago, Illinois;
2. Conduct an investigation prior to
rulemaking to study the health
effects from many toxic substances
in air, land, and water in the SE
Chicago area; and
3. Use TSCA authorities to assess
and remedy the public health
situation as a whole, and not with
piecemeal regulations.
That EPA ban the use of asbestos in
original equipment and replacement
brakes for on-road cars and trucks.
That EPA commence regulatory
action on dioxins and
dibenzofurans (denied) and initiate
multimedia investigations and
research (granted)
That EPA issue a ruje under section
4 requiring the scientific testing of
certain toxic chemical substances
and mixtures identified as
pollutants in Southeast Chicago.
Denied 10/31/84
49 FR
43764
Granted 12/19/84
49 FR 4931
Partial 1/30/85
Grant 50 FR 4426
Denied 7/26/85
50 FR
30517
60
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