United States Office of Pesticides June 1987
Environmental Protection and Toxic Substances
Agency Washington DC 20460
&EPA Toxic Substances
Control Act (TSCA)
Report to Congress
for Fiscal Year 1986
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CONTENTS
1. INTRODUCTION 1
2. HIGHLIGHTS 3
PROGRAM IMPLEMENTATION 3
Enforcement 6
International Activities . 6
3. NEU CHEMICALS 8
Program Status 8
PMN Review 9
Exemptions 12
Test Data 12
Fol1owup SNURs 13
Category Evaluations 15
PMN User Fees 15
Bi otechnology 16
4. EXISTING CHEMICALS 19
Program Status 19
.RISK IDENTIFICATION ,, ....-./ .'.... .20
Section 8(c) Records ., 24
Section 8(d) Support to Multiple Programs 25
TSCA Chemical Inventory Update Rule 26
CAIR 27
Chemical Hazard Information Profiles (CHIPs) 27
Substitute Hazard Profiles 28
Section 21 Petitions ...28
Monitoring Activities 29
Underground Storage Tanks 32
RISK EVALUATION 33
Chiori nated Sol vents 33
Risk Assessments 34
Pesticide Inerts Project 35
Chemical Emergency Preparedness Program (CEPP) 36
Chemi cal Category Evaluati on 36
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RISK MANAGEMENT 37
Polychlorinated Biphenyls 37
TSCA Ground Water Protection Strategy 39
Quality Assurance 39
Asbestos 39
ASHAA Asbestos Activities » 44
Referrals 46
1,3-Butadi ene 47
Glycol Ethers 47
Toluenediamine 47
MBOCA ' .48
Formaldehyde .49
Chloromethane 49
Significant New Use Rules • 49
PBBs and tris 50
1,2,3,4,7,.7-Hexachloronorbornadiene 50
11-Aminoundecanoic Acid 51
HMPA and Urethane 51
Pentachloroethane 52
Methyl-n-Butyl Ketone 52
Chemical Advisories 53
5.. CHEMICAL TESTING- ,.. '. 55
' Program. Status ., ... — ;. .55
Test Rule-Development 57
Enforceable Consent Agreements 64
Quality of Data .' • 64
Test Guidel ines 65
6. SUPPORT TO OTHER PROGRAMS, REGIONS, AGENCIES, STATES, INDUSTRY ...66
Program Status .66
INFORMATION DISSEMINATION 67
Chemical Assessment Desk 67
TSCATS 67
GEMS 68
V1deos 68
INDUSTRY COLLABORATION 69
TECHNICAL EXPERTISE 70
STATE PROGRAM 71
MINET 73
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7. COMPLIANCE AND ENFORCEMENT 74
PROGRAM ACTIONS 74
COMPLIANCE ACTIONS 75
CIVIL ENFORCEMENT ACTIONS 76
8. LITIGATION '. 81
9. INTERNATIONAL ACTIVITIES 92
10. RESEARCH AND DEVELOPMENT ACTIVITIES 97
MAJOR RESEARCH ISSUES 97
Test Method Development 97
Structure-Activity Relationships (SAR) 98
Special Human Data Needs 98
Ecology: Transport/Fate/Field Validation 99
Health: Markers, Dosimetry, and Extrapolation 99
Exposure Monitoring 100
Biotechnology/Microbial and Biochemical Pest Control Agents ...100
Engineering Release and Controls 101
Ecology: Ecotoxicity and Risk Assessment 102
Support 103
TABLES .
1. Summary of New-Chemical Actions:
October 1, 1985-September 30, 1986 10
2. Summary of Existing Chemical Activities 24
3. PCB Disposal Actions 38
4. Summary of Chemical Testing Actions 58
5. Administrative Civil Actions Taken under Section 16
of TSCA, Complaint's Issued, Cases Completed, and
Amounts Assessed (by Region) 80
APPENDICES
A. Summary/Guide to Information Required by Congress 104
B. Major FY 1986 TSCA Actions 109
C. Chemical Hazard Information Profiles (CHIPs) ...; 120
D. Substitute Hazard Profiles 120
111
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E. Section 4 Test Studies Received 121
F. NTP Studies Received 121
G. FY 1986 Section 21 Petitions 122
H. Summary of Research and Development Activities 123
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ABBREVIATIONS
AAP Ashestos Action Program
ANPR Advance Notice of Proposed Rulemaking
ASHAA Ashestos School Hazard Abatement Act
BSCC Biotechnology Science Coordinating Committee
CAIR Comprehensive Assessment Information Rule
CHIP Chemical Hazard Information Profile
CMA Chemical Manufacturers Association
CPSC Consumer Product Safety Commission
EDF Environmental Defense Fund
FPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide
Act
FWS U.S. Fish and Wildlife Service
GLP Good Laboratory Practice
HF.SAP Health and. Environmental Studies Audit Program
HSWA Hazardous and Solid Waste Amendments
IPCS International Program on Chemical Safety
IRPTC International Register of Potentially Toxic
Chemicals
ITC Interagency Testing Committee
NBM National Rlood Network
NCI National Cancer Institute
NFR Notice of Final Rulemaking
NHATS National Human Adipose Tissue Survey
MIEHS National Institute of Environmental Health Sciences
NinsH National Institute for Occupational Safety and
Health
NPR. Notice of Proposed Rulemaking
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NSF National Science Foundation
NV'F National Wildlife Federation
NOC Noble Oil Company, Inc.
OFCD Organization for Economic Cooperation
and Development
OPTS Office of Pesticides and Toxic Substances
ORD Office of Research and Development
OSHA Occupational Safety and Health Administration
OSW Office of Solid Waste
OTS . Office of Toxic Substances
PAIR Preliminary Assessment Information Rult.
PMN Premanufacture Notification
RCRA Resource Conservation and Recovery Act
SFIH Service Employees International Union
SNIIR- Significant New I ISP- Rule
TSC'A ' Toxic Substances Control Act
IINFP United Nations Environment Program
WHO World Health Organization
VI
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1. INTRODUCTION
The Toxic Substances Control Act (TSCA), enacted in 1976, provides
the Environmental Protection Agency (EPA) with the authority and
responsibility to protect human health and the environment from
unreasonable risks arising from the manufacture, distribution,
use, or disposal of chemicals. . This ninth annual report to
Congress summarizes activities and accomplishments during Fiscal
Year 1986, and fulfills the Congressional reporting requirements
of TSCA sections 9(d), 28(c), and 30 (see Appendix A).
Through TSCA, EPA seeks to prevent or reduce the possibility
of injury to the public and the environment from harmful chemicals.
The authority of TSCA allows EPA to evaluate and regulate a chemical
at any stage in its life cycle including manufacture, processing,
commercial distribution, use .and disposal. Programs have been
implemented to evaluate chemicals prior to commercialization
through premanufacture notification for new chemical substances
and new uses of existing chemical substances (section 5); to evaluate
existing chemicals by requiring testing (section 4) and reporting
of unpublished health and safety data (section 8); and to control
unreasonable risks of existing chemicals through regulatory
action (sections 6 and 7). EPA may also refer a substance to
another Federal agency for action (section 9) in the event that
TSCA is not the most appropriate mechanism for controlling the
particular situation. In any event, appropriate control actions
are instituted after carefully weighing the risks posed by a
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substance against the benefits it provides and the associated
costs of regulation.
As a result of these programs, data are being collected on
a number of chemical substances subject to recordkeeping and
reporting rules* Models have been created to calculate exposures
to various toxic substances, and surveys have been conducted to
determine current levels of exposure. 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 evaluation. Laboratory inspections
and data audits ensure the quality and integrity of data received
from industry as a result of chemical testing.
To ensure compliance with regulations, TSCA authorizes both
civil and criminal penalties for violations.. Specific strategies'
and.tools have been developed and implemented to enforce TSCA
regulations.
TSCA's ninth year of operation finds EPA enhancing the
existing chemical management process, coordinating cross-media
toxic evaluations, sharing TSCA acquired information with other
programs and Federal Agencies, and expanding the use of TSCA
authority to contribute toward the solution of toxic problems
identified in various program media.
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2. HIGHLIGHTS
PROGRAM In FY 1986, EPA advanced all areas of implementation. In addition
IMPLEMEN-
TATION to meeting the statutory requirements of the Act, EPA focused on
data management activities. Major efforts were undertaken to
share collected data and technical expertise with other EPA
programs, Federal agencies, regions, and States.
FY 1986 was the first year that TSCA authority was used to
address the chemical problems of other EPA programs and other
Federal agencies. The Comprehensive Assessment Information Rule
(CAIR) was developed under the authority of TSCA section 8(a) to
consolidate many information-gathering requirements into a
single rule. As proposed this rule will obtain information
to support the assessment and regulation of 47 chemicals identified
by EPA, OSHA, NIOSH, and CPSC; other chemicals may be added if
necessary. Additionally, the information collection authority
of section 8(d) was used to obtain unpublished health and safety
studies on 33 chemicals that are subject to the 1984 RCRA amendments,
and on another 107 chemicals which were identified by multiple
users in EPA and CPSC. Section 4 was also used for the first
.time to acquire test data on a chemical, 1,1-dichloroethylene,
that is being investigated under the Clean Air Act.
TSCA data supported the Chemical Emergency Preparedness
Program (CEPP) that was developed in FY 1986 to address sudden
accidental releases of chemicals that are potentially acutely
hazardous. TSCA data bases were also used to help develop an
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acute hazard list, of 4fi? toxic substances; these were identified
as chemicals that could potentially cause serious human hpalth
effects from short-term pxposure.
Tn FY 1Q%, the Agency promulgated the Inventory Updatp ^ule
requirinq manufacturers and importers to report currpnt production
volume and site data on many of the more than K£,nnp chemicals
that are on the TSCA Chemical Substances Inventory. Thp rule
reprpsents the first update since 1Q77, and includes new
substances that have been added to the Inventory after r°view
under section 5. Current production volume and site data are
imperative in estimating new and existinq chemical exposure?..
The New Chemicals program continues to he one of FPft's
ma.ior tools in prpventinq future health and envi ronmpntal problems.
In FY 1986, the Agency received ?,?!.?. new ckpmir:al substance
notices.' This is the highest annual volume received since the
program's incept'ion in 1^79, whrch ^rinos the total number
received to date to £,511. Mew chemical substance notices
include premanufacture notifications (PMNs), as well as
polymer PMMs, low volume exemption notices, and test market
exemption applications:. Under section F(e) this ypar, FPfl
issued more orders directed to new chemicals than in any other
year. The testing requirements that were imposed on PMN submitters
last year are beginning to yield toxicity data that support the
evaluation of new substances, and enhance rPA's ability to protect
human health and the environment from unreasonable risk.
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Criteria designating certain new biotechnology substances
as new chemical substances were developed, as well as scientific
tools to assess the risks of these substances. Throughout FY
1986, EPA continued to work closely with Federal agencies and
international organizations on biotechnology issues. A Statement
of Policy was published in June 1986, describing how five Federal
agencies will use existing laws to ensure protection of human
health and the environment from biotechnology research and
products.
Asbestos continues to be a priority concern at EPA, with
emphasrs on worker protection requirements for asbestos abatement
activities in schools and buildings. In April 1986, EPA published
*
a final rule effectively extending the protection of the OSHA
Asbestos Standard to State and local asbestos abatement workers
outside of OSHA-jurisdiction. In January 1'986, EPA proposed a
rule which would ban the manufacture, import and processing of
certain asbestos products, and phase out the use of asbestos in
other products. All products that are not immediately banned
would have to be labeled as containing asbestos. EPA also
produced several guidance documents that incorporate the latest
information on asbestos control and abatement activities.
The Chemical Testing program introduced a new approach of
using enforceable consent agreements as an alternative to test
rules, when consensus can be reached on testing. This approach
will expedite testing, while providing, safeguards equivalent to
those of test rules.
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Enforce- In FY 1986, EPA continued to enforce the provisions of TSCA through
ment
inspections and by issuing civil and criminal compliants where
violations were identified. This fiscal year, EPA inspections
focused on PCBs (1,639 inspections), and asbestos in schools
(2,393 inspections). In addition, the Agency conducted. 1,005
inspections on chemical substance imports, 393 inspections on
new chemicals, 452 inspections for compliance with reporting and
recordkeeping under TSCA section 8, and 16 inspections of labor-
atories for compliance with Good Laboratory Practices (GLPs).
In the enforcement area, 781 civil complaints were issued.
The majority of these were for- asbestos-in-schools (425) and PCB
(323) violations. In FY 1986, the Agency also issued complaints
for violations of section 8(a) of TSCA (2), for TSCA section 13
import requirements. (23), and. TSCA section.5 (3).
Inter- In FY 1986, EPA" continued to actively participate in international
national
Activi- programs. Good Laboratory Practice (GLP) experts met and reached'
ties
agreement on two documents: the Guide for Compliance Monitoring
Procedures for Good Laboratory Practice, and Guidance for the
Conduct of Inspection and Study Audits. A group of experts met
twice in FY 1986 regarding the exchange of confidential information.
The group designed a model form for bilateral agreements as well as
guidance for countries negotiating such agreements. The Chemical
Information Switchboard continued its operations during FY 1986
and increased access to unpublished information on chemicals for
its member States. Also during FY 1986, four new test guidelines
in genetic toxicology were adopted by the OECO Council; the Updating
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Panel endorsed revisions to three acute toxicity guidelines,
primarily as a result of concern for animal welfare.
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3. NEW CHEMICALS
.Program The goal of the new chemicals program is to protect human health
Status
and the environment from the harmful effects of new chemical substances,
New substances are defined as those which do not appear on the TSCA
Chemical Substances Inventory.
Under section 5(a) of TSCA, manufacturers are required to
provide FPA with a premanufacture notification (PMN) 90 days prior
to manufacture or import of a new chemical substance. Following
EPA's review and evaluation of the PMN, if information available
to EPA is insufficient to permit a reasoned evaluation of the
substance, and EPA-determines that the activities may present* .
an unreasonable risk of injury to human health or the environment
or that the substance will he produced in substantial quantities and
will resu.lt in significant nr substantial human exposure or
substantial release to the environment, .a section 5fe) order-may
be issued to limit or prohibit manufacture, .import, processing,
distribution in commerce, use, or disposal of the substance,
pending development of the test data needed to evaluate the
potential hazard.
Regulations under section R also require manufacturers to sub-
mit a Notice of Commencement of Manufacture after PMN review,
when actual manufacture begins, at which point the new suhstancp
is added to the TSCA Chemical Substances Inventory.
Additionally, EPA may monitor new and existing substances
that could be of concern should their uses change or production
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volume increase significantly, via significant new use rules
(SNURs). Under a SNUR, any person who intends to manufacture or
import a substance for a designated "significant new use" would
be required to submit a notification for EPA review much like
a PMN.
Although the new chemicals program has become increasingly
effective, the growing volume of PMNs, has necessitated new procedures
to streamline and standardize the review process. In FY 1QR5, for
example, EPA implemented two exemption rules which shortened the
review period for certain polymers and low volume chemicals.
Total new chemical substance submissions, which include
PMNs, Tow volume exemption notices, polymer PMNs, and test market
exemption applications, reached ?,?13 in FY 1986 fa 20"? increase
over the 1,784 in FY 1985).
PMN Review
Since the beginning, of the HPW chemicals program in 1979, FPA has
received 7,356 valid PMNs. In FY 1986, EPA received 1,693 PMNs, thP
greatest number received in a sinale year. Most of the new substances
reviewed did not reguire regulatory action. The Agency took action
on the remainder according to several renulatory options available
under TSCA section 5. EPA issued 49 section 5(e) orders controlling
exposure to 67 substances, pending development of additional data.
In addition, 45 PMNs were withdrawn by their submitters in anticipation
of EPA action under section 5(e) or 5(f). Table 1 summarizes new
chemical actions.
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Table 1
Summary of New Chemical Actions
October 1, 1.985-Septemher 30, 1986
Actions
Total Mew Chemical Substance Submissions Received
(PMNS;._Iest Market, Polymer, and ^
Low Volume r — "
^ s <
Valid PMNs Received
PMMs Requirinq No Further Action
Voluntary Testing in Response to FPA Concerns
Voluntary Control Actions by Submitters
PMNs WitHdrawn in Face- of 5(e)/5(f)
PMNs Subject to section 5(e) Consent Orders*
PMMs Subject to Unilateral section ^fe) Orders*'
PMNs 'Subject to section -5 ff) Rules
Number of Chemicals for which Commencement of
Manufacture Notices Were Received
Submissions of Bona Fide Intent to Manufacture
New Substances Subject to Proposed Siqnificant
New Use Rules
New Substances Subject to Final Significant
New Use Rules
Test Data Received as a Result of Section R(e)
Consent Orders
Valid Test Market Exemption Applications Received
Granted
Withdrawn
Denied
No. of
Actions
in FY'86
2,213.
1,693
1,414
18
0 .
47
66
. 0
o
1,098**
543
13***
1***
25
56
48
7
0
Aqareqated
Total To
Hate fsince
-mid-107Q)
8,511
7,35fi*
^,7fi! '
fi4
33
139
27! a
. 1.2
4
3,678
?,631
B5
15
?5
4?7
377
40
6
10
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Polymer PMNs Received 233 387
Granted 198 32*
Withdrawn 35 RR
Low Volume Exemption Notices Received ?34 31.fi
Granted 223 298
Withdrawn - 8 11
a Includes lOfi synfuels.
*A section 5(e) consent order is issued hy FPA with the agreement of the PMN
submitter. A section 5(e) unilateral order is issued hy FPA without the aoreement
of the PMN submitter.
**This number includes PMNs received in previous fiscal years for which commence-
ment of manufacture notices were received, in FY-1986-.
***This number includes substances which were the subjects of PMNs receivpH in
previous fiscal years but for which proposed-or final rules were not published
until FY 19PR..
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Exemptions Certain requirements for exemptions from PMN review or from the
full 90-day PMN review process were written into the statute.
These include exemptions for research and development (R&D), and
test marketing exemptions (TME). Substances manufactured
solely for R&D are exempt from PMN review. However, manufacturers
of R&D substances must meet requirements set forth in a final rule
published in April 1986, clarifying R&D provisions.
New substances produced for limited test marketing are subject
to an abbreviated 45-day review.. A test marketing exemption
application must be submitted for EPA review prior to commencement
of test marketing activities. If a manufacturer subsequently
wishes to commence full-scale commercialization of the new- substance,
a PMN must be submitted for -a full 90-day PMN review.
Other exemptions from full PMN review have been created by
regulation-.. These include exemptions, for certain polymers and low
volume substances. Polymer PMNs and low-volume exemption notices
are subject to a 21-day review period.
These actions are summarized in Table 1.
Test
Data EPA may ask for pre-production testing if this can be done quickly
and without unreasonable expense, or if the Agency has reason to
suspect that potential risk may not be adequately characterized.
EPA can issue section 5(e) orders with "testing triggers" if the
potential risk can be controlled until a substance reaches a
predetermined production volume; production above the stipulated
volume requires that test data be submitted. In FY 1986, EPA
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issued 12 section 5(e) consent, orders with testing triggers.
Test data, prompted by section 5(e) consent orders, were received
on 25 PMN chemicals. These test data have additional value, as
the data are shared with other FPA programs.
Followup
SNURs
'TSCA authorizes FPA to monitor new and existing substances that
may be.of concern if their uses chance, or if production volumes
increase significantly from those estimated in the PMN. Under
TSCA section 5, EPA may determine by rtilf that certain uses of
chemical substances are significant new uses. These rules are
referred to as significant new use rules (SNUPsU In manna such
a determination, the Agency considers the potential exposure
associated with thp us.*3, *"he toxicity associated with the substance
and whether the use is ongoing at the time-the rule is proposed.
Persons subject to a SNUR must notify FPA at least Q0 days hpfnro
manufacturing, import!no, or processinq the chemical substance
identified in t>e SNUR for the defined significant new use or uses.
A SNUR may be issued for any TSr.A chemical substance, includina
individual substances and chemical categories, and for new or
existing substances. A SNUR may be written in conjunction with a
section 5(e) order.
A section 5(e) order can limit or prohibit the use of the
chemical substance that is the subject of a SNUR. Once commercial
manufacture of a new substance begins, it is placed on the Inventory.
If no SNUR is issued, this substance may he manufactured, processed
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or used hy others without any restrictions. To establish equity nf
treatment, EPA issues SNURs on new substances .which are subject 1
section 5(e) orders, thus requirina other persons who intend to
manufacture the substances to notify EPA before manufacturino,
importing, or processing the substances for any activity other tl
those specifically permitted in the section 5(e) order.
The Agency also writes followup SNURs for certain new su^s' ;
which were not subject to section 5(e) orders. These SNURs address
concerns which had not ori.ginally triggered a section 5(e) order
either because the concerns arose after the completion of the PMN
review, or because-the uses described in the PMN did not' involve
enough exposure to warrant action. Followup SNURs allow the Aoency
to permit safe uses of potentially hazardous new substances, while
ensuring that it Has the- opportunity to review uses which may lead
to. signi-f-icant changes in human- or environmental exposure. . •
Additionally, EPA develops SNURs which support the existing
chemical program's risk assessment an-d risk management activities by
monitoring significant new uses of substances that are on the TSCA
Chemical Substance Inventory. These SNURs enable EPA to take immediate.
followup control action to limit potential exposure resultinq from
significant new uses of existing chemical substances.
EPA proposed 8 SNURs covering 13 PMN substances in FY IPflfi and
promulgated 1 SNIIR covering 1 PMN substance (see Appendix B).
In addition to the SNURs on PMN substances, EPA proposed 5 SNURs
on 1? existing substances, and promulgated 4 SNURs on 4 existing
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chemicals under the authority of section 5 (see Appendix B and
Chapter 4).
Category
Evaluations Until FY 1986, new and existino chemical SNDRs were developed
on a case-by-case basis, tailored to meet specific circumstances.
In April 1986, EPA introduced the listing SNUR for acrylate
substances. That SNUR, as proposed will establish in the Code
of Federal Regulations (CFR) a list of the significant new uses the
Agency routinely designates for acrylates and a list of recnrdkeeping
provisions the Agency requires for those significant new uses in a
chart format. The chart will contain the name of the substance,
references to the appropriate significant new uses selected from the
established standard list, and references to the applicable record-
keeping requirements'. F'ach time a SNUR is issued for an acrylatp
substance an addition will he made to the chart.. This SNHP eliminates
the development of new significant new use triggers each time an
acrylate SNUR is proposed.. By means of this mechanism, the Aciency
hopes to speed up the process of issuing SNURs for acrylates and to
make those SNURs more uniform.
PMN EPA is planning to use the authority of section ?6(h) to require
User
Fees a fee for premanufacture notifications, exemption applications and
notices, and significant new use notices submitted under TSCA
sections 5(a) and (h). The Agency prepared a paper that discussed
options for setting a fee and provided preliminary estimates of the
economic impact of such a fee. The Federal Register announced the
availability of the "Options for PMN Fees" paper in July 1986,
soliciting comments on the options it presented. Subsequently,
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a proposed rule has been developed that will propose the fee option
of $100 for section 5 premanufacture notices submitted by
small business concerns, $100 for low volume exemption notices,
$100 for test market applications, and $2,500 for all other
section 5 notices. The proposed rule will be published in
FY 1987.
Biotech- In June 1986, a Statement of Policy was published describing.
nology
how five Federal agencies will apply their respective authorities
to biotechnology research and products in order to protect human
health and the environment from potential hazards. Each of the
five agencies is charged with assessing a portion of the risks and
benefits resulting from artificial manipulation of the genetic
structures of plants,, animals or microorganisms. Existing Federal
laws will then provide a basic network of jurisdiction over.-both
research and products-
Five agency-level committees have been formed. The purpose of
EPA's agency-level advisory committee is to provide advice on
scientific issues pertaining to biotechnology. The EPA Bio-
technology Science Advisory Committee is comprised of 11 members,
nine from the scientific community; the other two representing
general public policy issues.
On July 9, 1986, the first public meeting of the Biotechnology
Science Coordinating Committee (BSCC) was held in Washington, D.C.
The Committee received oral comments from the public on the Federal
biotechnology policy. The BSCC was established on October 31, 1985,
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and consists of senior policy officials from the agencies involved
in the oversight of biotechnology research and products. It is
authorized to hold public meetings in order to discuss public
concerns about issues involving biotechnology. The Committee was
formed by the Federal Coordinating Council for Science, Engineering
and Technology, a statutory interagency coordinating mechanism
managed by the Office of Science and Technology Policy, which
operates out of the Executive Office of the President. Its mission
is to coordinate science activities among Federal agencies.
EPA is responsible for regulating microorganisms used as
pesticides, or for general industrial or environmental purposes.
EPA's biotechnology policy gives special consideration to three
categories of microorganisms: 1) microorganisms that contain new
combinations of traits, or'that are new to the environment in
which they are used; 2) microorganisms that are pathogens, or
contain genetic material from pathogens, except those that are
native to the area where they will be released; and 3) all other
microorganisms that are subject to the Federal Insecticide, Fungicide
and Rodenticide Act or TSCA, and are deliberately released into the
environment.
Microorganisms altered to contain genetic material from
dissimilar source organisms through deliberate human intervention
(intergeneric microorganisms) are considered "new" and are therefore
subject to premanufacture notification requirements if they are
manufactured for TSCA purposes. This policy became effective when
the Statement of Policy was published.
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Testing in the environment of "new" (inter-generic) micro-
organisms will not fall under the R&D exemption from the PMN
process that is accorded to other R&D substances. Thus, persons
developing "new" microorganisms for commercial purposes will be
required to notify EPA prior to environmental releases. Rulemaking
will be required to fully implement this component of EPA's policy;
until the necessary rule changes are promulgated, EPA expects to
be voluntarily notified of such uses.
Because of its concern that certain microorganisms will not
be subject to PMN policies but should nonetheless be reviewed, EPA
expects to complement its PMN policy with a requirement to be notified
prior to new environmental uses of genetically engineered micro-
organisms that are pathogens or contain genetic material from
pathogens. This would be accomplished through a "significant new
use rule" issued under section 5(a)(2) of TSCA. Again, until any
rule is promulgated, EPA expects" to be-notified, of such releases
on a voluntary basis.
The Agency intends to require that some information be reported
to EPA prior to all environmental uses of microorganisms that are
subject to TSCA but not subject to the PMN or significant new use
requirements described above. To accomplish this, EPA intends to
promulgate a rule under the authority of section 8(a) of TSCA.
EPA also intends to consider an exemption from PMN requirements
for "new" microorganisms used solely in contained systems and
never intentionally released to the environment.
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EPA must be notified by manufacturers, processors or distributors
of microorganisms immediately if they become aware of any new
information that suggests that any microorganisms present a substantial
risk of injury to human health or the environment. This is not a
new requirement; it applies to all substances subject to TSCA.
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4. EXISTING CHEMICALS
Program The goal of the existing chemicals program is to reduce unreason-
Status
able risks of injury to health or the environment from chemicals
already in commerce. The objectives of this program include
identifying potential risks to public health and the environment,
evaluating those risks, and when appropriate, addressing those
risks with regulatory actions under TSCA or another relevant
authority. TSCA addresses all phases of a chemical's life cycle,
including manufacture, processing, distribution,..use, and disposal.
To identify potential risks, EPA uses the authority of TSCA
section 8 to gather information about exposure and toxicity of
particular chemicals- When data, are unavailable or insufficient,
TSCA section 4 authorizes EPA to require testing by manufacturers
and processors..
The Agency makes' a risk assessment of a given--chemical based on
analysis of exposure data and health and environmental effects data.
From the available information and the risk assessment, EPA makes
a decision 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 and 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
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which raise some concern, hut do not necessitate immediate
regulation. FPA can control unreasonable risks through regulatory
action under the authority of section fi, or require immediate
elimination of any imminent hazards under section 7. When TSCA
is not the most appropriate mechanism for given exnsotire or
risk situation associated with a chemical of concern, that chemical
will be referred to another Federal authority for action under
section 9.
Only those chemicals with identified unreasonable ri'sks are
addressed in all phases of the program descrihed above. Chemicals
that are not found to pose unreasonable risks are drooped from
further evaluation; resources are reproqrammed into evaluation of
potentially more hazardous chemicals.
Ourinq FY 19flfi, 76 chemicals were considered in the Fxistinq
Chemicals Program review process, flf that number, fi were referred
for information .qathering rules includino testing, and ^1 are
undergoing further evaluation. Table ? summarizes existing
chemical program activities.
Kl 3N
IDENTI-
FICATION
The authority of TSCA section P allows FPA to require reporting
and recordkeeping relating to chemical substances and mixtures.
Section 8(a) allows FPA to promulgate rules that require manufacturers,
importers, and processors to maintain records and report certain
information to the Agency. The section P(a) Preliminary Assessment
Information Rule (PAIR) requires manufacturers and importers of the
chemicals that it specifies to report general.production, use and
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exposure information using the rule's Report Form. These data are
especially important to the Agency's review of chemicals designated
by the Interagency Testing Committee (ITC) for priority testing
consideration. EPA may also add non-ITC chemicals to the rule.
In FY 1986, EPA developed the Comprehensive Assessment Information
Rule under section 8(a), designed to consolidate a comprehensive
list of reporting provisions and questions into a model rule.
This rule is expected to reduce duplicative efforts within EPA and
other Federal agencies as well as industry reporting burdens.
This information must be provided to EPA upon request. Under
section 8(c), manufacturers and certain processors must maintain
records of alleged "significant adverse reactions". In FY 1986,
EPA required s-ubmission of such records for the first time.
Amendments to EPA's section 3(c) rule in FY 1986 exempt coincidental
manufacturers of substances and revise the description of processors
Section 8(d) requires certain manufacturers, importers, processors,
and distributors to submit lists of unpublished health and safety
studies to EPA. In FY 1986 EPA amended the model Health and Safety
Data Reporting rule. This model rule requires past, current, or
prospective manufacturers, importers and processors of certain
named substances to submit unpublished health and safety data to
EPA. EPA adds substances to the model rule as the Agency
identifies a need for health and safety information. Under
section 8(e), persons who obtain new information that reasonably
supports the conclusion that a substance or mixture which they
manufacture, import, process or distribute presents substantial
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risk of injury to human health or the environment must notify
EPA within 15 workinq Days. These notices are then reviewed and
an initial evaluation (status report) is prepared containing,
if appropriate, follow-up questions to the submitter, referrals to
other agencies, and recommended EPA followup actions. The Aqency
also receives a large numher of "For Your Information" (FYI)
submissions, submitted voluntarily to the Aqency on chemical
toxicity and/or exposure. FYIs are submitted by chemical
manufacturers, processors and distributors, trade associations,
labor organizations, Federal, State or local anencies, foreign
governments, academia, public interest and environmental cirouns,
as well as by the general public. Another source of data on
existing chemicals risks is the National Toxicology Program, from
which test data are routinely received and reviewed.
In FY 1986, 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 160 chemicals.
Section 8(a) and section 8(d) rules resulted in submission by the
chemical industry of 362 studies and reports on existing chemicals,
Under the section 8(e) substantial risk notification proqram, FPA
received 66 initial submissions, 125 supplemental/followup
submissions to previous section 8(e) initial reports, and 20F
"For Your Information" submissions, totalling 3% for FY 1986.
A total of 97 completed test studies required under section 4
were received from industry (see Appendix F.). Twenty-one National
Toxicology Program studies were also received and reviewed (see
Appendix F).
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Table 2
Summary of Existing Chemical Activities
Risk Identification # in FY 1986
Section 8(a) Preliminary Assessment Reports Received 31
Section 8(d) Health and Safety Studies Received 331
Section 8(e) Substantial Risk Notification Program:
- Initial 8(e) Submissions . 66
- Supplemental/Followup 8(e) Submissions 125
- "For Your Information" (FYI) Submissions 205
Chemical Hazard Information Profiles (see Appendix C) 10
Substitute Hazard Profiles (see Appendix D) 17
Testing Studies Received under Section 4 (see Appendix E) 97
National Toxicology Program Studies Reviewed (see Appendix F) 21
Section 21 Petitions Received (see Appendix G) 5
Risk Evaluation # in FY 1986
- Continued assessment 51
- Referred for risk management 3
- No further action required 13.
- Section 4(f) designations' 0
- Referred for information gathering 6
Risk Management # in FY 1986
Proposed and final rules under section 6 3
Proposed and-final rules under section 6(e) 1
Chemical' Advisories . 2'
•Proposed and final, significant:, new-use. rules 9
Sect.ion 9 Referrals 5
Section EPA published a TSCA section 8(c-) regulation in August 1983,
8(c)
Records requiring manufacturers and certain processors of chemical
substances and mixtures to keep records of significant adverse
reactions to health and/or the environment alleged to have been
caused by a substance or mixture. In FY 1986, for the first time
since the 8(c) regulation became final, EPA required submission
of such records. Two sets of records were submitted on poly-
fluorinated or partially fluorinated compounds used in preparations
for water and stain repellent treatment of porous materials. The
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Section 8(d)
Support to
Multiple
Programs
Agency used these submissions to determine if the compounds showed
similar effects to others observed in animal toxicology studies.
EPA promulgated a final rule under section 8(d) of TSCA to collect
health and safety data for the Office of Solid Waste (OSW). This
rulemaking marked the first time that OTS specifically developed
a rule under TSCA authority to collect information needed for
another EPA program. The rule requires past, current, and
prospective manufacturers, importers, and processors of 33 chemical
substances to submit lists and copies of unpublished health and
safety studies on those substances to EPA. The mandates of the
Hazardous and Solid Waste Amendments of 1984 (HSWA) prescribe
statutory deadlines by which EPA must develop land disposal
restriction regulations for certain substance-s that are subject
to the Resource Conservation and Recovery Act (RCRA). If these
deadlines are not met, the HSWA impose an automatic ban on the
land disposal of the substances. OSU is devising treatment standards
with regard to which health and safety data on the 33 substances
are needed.
In August 1986, EPA proposed another section 8(d) rule adding
107 chemical substances nominated by EPA's Office of Drinking Water,
Office of Water Regulations and Standards, Office of Solid Waste,
Office of Toxic Substances, and the Consumer Product Safety
Commission. This coordination will lead to resource savings for
both industry and the government by avoiding duplicative information
requests by multiple offices.
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TSCA-Chemical The TSCA Chemical Substance Inventory is a list of all chemical
Inventory
Update Rule substances that are in commerce in the U.S. The data originally
reported for the Inventory included 1977 production volume and site
data. Since these data are nine years old, their reliability is
diminishing. Therefore, in FY 1986, the Agency promulgated a
section 8(a) rule that requires manufacturers and importers of
certain chemical substances included on the Inventory to report
current data on production volume, plant site, and site-limited
status. The information collected under this rule will be used
by EPA for chemical screening, priority setting, exposure
determination,, as well as support, for risk assessment and develop-
ment of TSCA regulations.
This rule became effective on August 25, 1986. During the
initial reporting period, August 25 through December 23, 1986,
every manufacturer or importer who produces or imports 10,000
pounds or more, per year of a substance covered by this rule must
report separately on every substance at each plant site. After
the initial reporting period, the same type of reporting will be
required every four years, as long as the rule is in effect. Four
categories of substances on the TSCA Inventory are generally
excluded from reporting: polymers, inorganic substances, micro-
organisms and naturally occurring substances. However, no substance,
except one that is naturally occurring, is excluded from reporting
if the substance is: subject to an order issued under section 5(e)
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of TSCA; or subject to a rule proposed or issued under section
4, 5(a)(2), or 5(b)(4), or to a rule issued under section 6 made
immediately effective under section 5(f); or is subject of relief
granted under a civil action under section 5 or 7. Small businesses,
as defined by the rule, are exempted from reporting; even they,
however, must report substances which are subject to an order,
rule, or action listed above (except section 5(a)(?) SNMJRs).
Comprehensive EPA has proposed a model information gathering rule under TSCA
Assessment
Information section 8(a) to obtain data on the manufacture, import, and
Rule (CAIR)
processing of chemical substances and mixtures. This model rule-
making, called the Comprehensive Assessment Information Rule
(CAIR), establishes uniform reporting and recordkeeping require-
ments along with a list of questions from which specific
information requests <*re to he assembled on a chemical-hy-chpmical
basis. This rule would obtain information needed by -FPA, OSHA,
' NIOSH, and CPSC to support the assessment and regulation of d7
chemical substances and mixtures. EPA expects to add other
chemicals to the rule in the future; thus, any chemical manufacturer,
importer, or processor is potentially subject to it. CAIR is
expected.to he time- and cost-efficient both for industry and
for the participating Federal agencies.
Chemical • In FY 1986, EPA prepared in Chemical Hazard Information Profiles f.CHIPs)
Hazard
information for 51 chemicals (see Appendix C). A CHIP is a brief summary of the
Profiles
information that is readily available concerning the health and environ-
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mental effects and the potential exposure scenario of a particular
chemical or chemical class. CHIP candidates are chosen if the information
available indicates a potential for adverse health or environmental
effects, or if there is evidence of significant production or
exposure. Information gathering for a CHIP consists primarily
of a search of secondary literature sources, including computerized
data bases, scientific review documents, and reference works. In
preparing a CHIP, EPA also solicits unpublished information from
industry, other government agencies and various other institutions
that are involved in chemical risk assessment.
Substitute Seventeen Substitute Hazard Profi>es were prepared in FY 1986 as
Hazard
Profiles part of the overall risk identification and evaluation process
(see Appendix D).. Substitute Hazard Profiles, similar in content
and. format, to CHIPs, are preliminary risk identification documents'..
If one chemical is~ being considered for risk, management' action
under TSCA, these profiles will help to ensure that an even more
hazardous chemical is not substituted for the first one.
Section 21 Under section 21 of TSCA, any person may petition the EPA Adminis-
Petitions
trator to initiate a proceeding for the issuance, amendment, or
repeal of a rule or order under various sections of the Act. With-
in 90 days of when the petition is filed, EPA must either grant or
deny the petition. If it is granted, EPA must promptly commence
an appropriate proceeding in accordance with section 4, 5, 6, or 8
of TSCA. Denials must be published in the Federal Register along
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with EPA's reasoning. 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. Five petitions were received in FY 1986, one of
which was withdrawn, three of which were denied, and one is pending.
A petition that was submitted by the Environmental Defense Fund
and the National Wildlife Federation in FY 1985, and partially
granted in FY 1.985, resulted in a regulatory investigation of
dioxins and furans. The actions taken included a proposed section
4 test rule and a section 8(a), (c), and (d) information gathering
rule, both published in December of 1985.
In FY 1986, EPA published guidance for preparing citizens'
petitions. This guidance is intended to help petitioners
effectively present their concerns to EPA with the maximum amount
of documentation. Use of this guidance will help the Agency
properly evaluate petitions within the mandated 90-day review.
Monitoring Several chemical-specific and broad-based monitoring activities
Activities
were undertaken in FY 1986 to support regulatory decisionmaking
on new and existing chemicals.
The National Human Monitoring Program (NHMP) monitors the
prevalence and levels of exposure to toxic substances in the U.S.
population. These data are used to identify trends, assess regulatory
efficacy and to provide environmental results measures. In FY
1986, emphasis was placed on increasing EPA's capability to assess
existing chemical problems through the use of human body burden
data.
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The National Human Adipose Tissue Survey (NHATS) is currently
the main program under the NHMP. The NHATS has been expanded to
monitor additional chemical classes by means of a new analytical
protocol. To assist in this change, a methods comparability
study is underway to compare old and new protocols. In addition,
a special study of the unidentified chromatographic peaks from a
previous broad scan analysis has resulted in the identification
of additional compounds for assessment.
EPA and the Veterans Administration are working on a
collaborative project to study'dioxin and furan levels in human
adipose tissue of Vietnam Veterans and matched control samples of
non-Vietnam Veterans and non-veterans. The National Human Adipose
Tissue Survey is the source of specimens for this retrospective
study.
EPA is participating in a cooperative study with the Ecological
and Toxicological Association of the Dyestuffs Manufacturing Industry
and the American Textile Manufacturers Institute. The purpose of
the study is to improve EPA's assessment of exposure and associated
risk from the use of powdered dyes in the American textile industry.
During the first phase of the survey, a questionnaire was sent to
a representative sample of the industry to collect general
information. The second phase involves the measurement of actual
exposure levels in a representative group of U.S. textile plants.
A wide variety of information is being collected characterizing
the dye/drug room operations at each site as well as the air
samples in the breathing zone of the workers. This study is
expected to be completed in late FY 1987.
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As part of the overall exposure assessment for methylene
chloride and five other solvent chemicals, EPA is examining
consumer exposure by means of data from a nationwide survey of
household usage of products containing these solvent chemicals.
Consumers were asked about their frequency, extent, and patterns
of use of different household .cleaning, lubricating, painting,
and automotive products. The data, which are currently being
analyzed, will be used to produce the consumer segment of an
overall exposure assessment for these chemicals. As part of the
planning of the national survey, a shelf survey was conducted to
determine the incidence and levels of methylene chloride in a
variety of consumer products.
EPA began collecting preliminary information on the presence
of chlorinated paraffins in water, sediment, biological tissue,
and associated environmental levels. . Samples were collected in
the Sugar Creek, Dover, Ohio area. Additional sites will be
be evaluated in FY 1987. An ancillary effort to see if chlorinated
paraffins can be found in human adipose tissue is also being planned,
using the National Adipose Tissue Survey as a mechanism to collect
the samples.
In support of the PMN program, a series of national surveys
was initiated to examine the frequency, duration and amount of
consumer use of certain products containing chemicals of interest
to EPA. Two surveys examined consumer usage of household cleaning
products and painting products, two categories into which many
PMN chemicals fall. The information from these surveys will be
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Underground
Storage
Tanks
used to support the exposure assessment process for new chemicals
manufactured for these types of products.
The FPA National Survey found that a significant proportion of
the nation's estimated 800,000 underground motor fuel storage
tanks may be leaking. The National Survey, conducted for
FPA's Office of Underground Storage Tanks, was" based on a national
probability sample of 890 establishments with.?,400 tanks on thp
premises. A random subsa^ple of ?1& establishments was chosen
for physical tank testinq, and at these sitps d?3 t.ank s.vstpms
were tested for tightness. An estimated 35 percent of fhese tank
systems failed the FPA' tightness tost, which ppnuired that the
tanks and associated piping be filled above normal operaHnn
levels. The information obtained in the survpy will bp n$pd by
FPA' when developing regulations to control leaking underground
motor fuel' storage tanks.'
RISK
EVALUATION
Major risk evaluation activities in FY 198F focused on the
regulatory investigation of formaldehyde and methylene chloridp.
The Agency prepared risk assessment documents on six potentially
hazardous chemicals. Additionally, a major toxic air pollution
strategy was produced by the Agency, indicative of orowing
attention to the problem of sudden accidental releases.
Chlorinated In FY 1985, FPA, under section *(f) of TSCA, announced that
Solvents
methylene chloride may present a risk of human cancer from certain
exposures. Methylene chloride is a high-volume chemical with a
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variety of uses, including as a solvent, aerosol . propel lant, and
degreaser. In October 19R6, the Agency published an Advance Notice
of Proposed Rulemaking (AMPR), announcing plans to conduct a
comprehensive interaqency regulatory investigation of exposures
to methylene chloride. Other Federal agencies participating
include OSHA, CPSC, and FDA.
A major issue in the regulatory investigation is that other
chlorinated solvents with similar toxicities could he used as
substitutes for methylpne chloride. The potential substitutes may
not result in significant risk reductions; therefore, the Aoency
is assessing the risks and benefits of alt-ernative regulatory
apnroaches for six solvpnts (carbon tetrachloride, trichloroethylenp,
perchloroethyl ene, trichloroe^hane, CFC-113, and methylene chioridp).
The use of other solvents in four use categories (decreasing, dry
cleaning, paint stripping and aerosols) are being evaluated.
EPA will assess the control measures of several statutes including
TSCA, the Clean Air Act, the Safe Prinking Water Act, thp Clean
Water Act, and the Resource Conservation and Recovery Act to
determine which will be most appropriate in this case. PPA win
also consider the regulations administered by other agencies,
including OSHA, CPSC, and FDA, as well as whether non-regulatory
options could suffice.
Risk Six risk assessment documents were prepared in FY IQPfi. The risk
.Assessments
assessment on the chemical perchloroethyl ene, used as a solvent in
dry cleaning and as a metal degreaser, addressed carcinogpnic
effects and general population, worker, and consumer exposure.
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Perch!oroethylene is now part of the chlorinated solvents strategy
described above. The risk assessment on 3-chloro-2-methylpronene,
an intermediate, addressed carcinogenic effects and exposure from
manufacturing and emissions. This document was prepared for the
State of Maryland. The risk assessment on l,4-dichloro-?-hutene,
also an intermediate, addressed workplace exposure and carcinogenic
effects. The document was prepared for OSHA, NIOSH, and the
manufacturers of l,4-dichloro-2-hutene. A risk assessment on
acrylamide, an intermediate in polyacrylamide manufacture, addressed
carcinogenic and systemic toxicity as well as mutagenicity.
Exposures to manufacturing workers and workers doina sewer line
grouting are expected. The risk assessment on paradichlorohenzene,
us^d as a deodorizer and moth repellant, addressed carcinogenic
risk to consumers. A final risk assessment addressed formaldehyde,
used in wood products, and in-moMle and conventional homes huilt
w-ith. urea-formaldehyde.
Pesticide EPA developed a proposed strategy for reaulating the toxic and
Inerts
Project potentially toxic inert ingredients that are used in pesticide
products, in order to minimize public health and environmental
risks. Of the 1?00 substances identified as inerts, most have
been tested only for acute toxicity, hut not for their potential
chronic effects such as cancer and hirth defects.
The 1200 inerts have been divided into four different
categories: toxic inerts (List 1 - known human and environmental
effects); potentially toxic inerts (List ?.)• inerts of unknown
toxicity (List 3); and inerts of minimal hazard (List 4).
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The Office of Pesticide Programs (OPP) is reviewing the 55
substances on List 1 in order to assess the extent of exposures
and risks each poses and subsequently to determine what, if
any, regulatory action is warranted.
The Office of Toxic Substances (OTS) is responsible for
managing the review of approximately 60 inert substances on List
2 which have high priority for testing. This involves gathering
any relevant data in the published literature, data developed
under EPA and other governmental testing programs, and data submitted
to EPA under TSCA section 8. OTS will work with OPP to identify
significant data gaps and to determine which mechanism under
FIFRA or TSCA is most.appropriate to obtain the necessary toxicity
data. EPA will then use these test data to determine if an inert
should be placed on List 1 for further action or on List 4 because
of minimal hazard.
Chemical In December 1985, EPA announced the development, of a voluntary
Emergency
Prepared- program to address accidental releases of chemicals that could be
ness
Program acutely hazardous. The Chemical Emergency Preparedness Program
(CEPP) was designed both to increase community awareness of
potential hazards and to stimulate the development of State and
local emergency plans for responding to chemical accidents. CEPP
produced a guidance document which included an introduction to
the program, sections on developing community emergency contingency
plans, gathering and analyzing site specific information, contingency
planning appraisal, and criteria to identify acutely toxic chemicals.
An interim list of 402 acutely toxic substances that have the
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potential to create an emergency situation accompanied the document,
plus information profiles on these substances. The guidance
includes a procedure to determine the minimum quantities of concern
for these chemicals.
Chemical EPA is evaluating the potential application of categorical approaches
Category
Evalua- for risk assessment of several groups of chemicals. This evaluation
tion
includes a review of the health or environmental concerns, 'exposure,
and economic aspects of these categories. The categories under
review were selected based on the experience of both the new and
existing chemical programs. The main criteria for their selection
for this review were concerns about the toxicities of several
of their constituent members and high levels of current activity
in the new or existing chemical programs. A decision is expected
in early FY 1987 on whether any of these categories, should enter a
more detailed analysis to determine the-need for regulatory activity.
RISK
MANAGEMENT
Risk management activities in FY 1986 resulted in TSCA section
6 actions or section 9 referrals on polychlorinated biphenyls,
asbestos, 1,3-butadiene, glycol ethers, formaldehyde, MBOCA,
toluenediamine and chloromethane. The Agency also developed
section 5 significant new use rules (SNURs) to monitor new uses
of substances on the TSCA Chemical Substances Inventory, including
PBBs, Tris, methyl £-butyl ketone (MBK), hexachloronorbornadiene
(Hex-BCH), hexamethyl phosphoramide (HMPA), urethane, 11-amino-
36
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undecanoic acid (11-AA1, and pentachloroethane. Descriptions of
some siqnificant FY 1986 activities are presented below.
Polychlorinated
Biphenyls
In FY 1986, EPA made substantial progress in developino
a nationwide policy for the cleanup of spilled PCPs. This
policy is being developed to establish consistent nationwide
standards for the cleanup of PC3s in soil and on surfaces such as
concrete and asphalt. The Agency hopes that by publishing its
standards for cleanup, industry will move quickly tn conduct
thorounh cleanups with minimal oversiaht by FPA. The existing
process involves consultation with the Regional offices prior
to cleanup and has led to protracted cleanups in some cases.
In FY 1°86, EPA continued to implement the TSCA section *(e)
prohibitions on polychlorinated biphenyls fPCRs) by is^m'na a
final rule in August 1986 that ^responded-to ??. petitions for
exemption from the prohibition against, manufacture, processinq,
and distribution in commerce of PCRs; 16 were granted, ? were
denied, 1 was granted in part and denied in part, and ? were
dismissed. TSCA provides that EPA may grant exemptions
if (1) the Administrator finds that there would be no unreasonable
risk to health or the environment, and (?.} good faith efforts have
been made to develop a chemical which does not present an unreasonable
risk, and which may he substituted for PCR.
In April 1986, EPA published "PCR Transformers and the Pisk of
Fire: A Guide for Ruilding Owners," an information leaflet designed
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to improve compliance with the final PCB Transformer Fires Rule
published in FY 1985. 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
in FY 1986 include the issuance of 10 research and development
(R&D) permits, 9 demonstration permits, and 5 nationwide disposal
permits (see Table 3).
Table 3
Actions on Nationwide PCS Disposal Permits
FY 1986
Applications Received: 18
R&D Permits Issued: 10
Permit Deficiency Letters: 16.
Demonstration Permits Issued: 9
Nationwide Final Permits Issued: 5
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TSCA The TSCA Ground-Water Protection Strategy focuses on sources of
Ground-
Water ground-water contamination that are not presently being emphasized
Pro-
tection by other Agency programs. In FY 1986, the TSCA Strategy
Strategy
concentrated on collecting information on the following potential
sources of ground-water contamination: septic tank systems;
agricultural chemicals outside the jurisdiction of FIFRA; fertilizers
used on lawns, gardens, and shrubbery; and volatile organic.chemicals
released through leaks, spills, and dumping, especially by small
industries and commercial establishments. The Agency will use
this information to develop strategies for preventing or mitigating
ground-water contamination from these sources.
Quality The Office of Toxic Substances Quality Assurance (QA) program is a
Assur-
ance dynamic and integral part of all intramural and. extramural projects
requiring environmentally related measurements. A major strength
of the QA program is the commitment and awareness that management,
at all levels within the program office, has with respect to
quality assurance. Through this commitment, and in concert with
a program which is practiced on a day-to-day basis, the OTS Quality
Assurance Program Plan was approved by the Agency's Quality Assurance
Management Staff. The OTS was one of the first program offices to
receive this approval.
Asbestos On April 25, 1986, EPA issued a final rule under TSCA to protect
State and local government employees from the potential hazards of
39
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asbestos abatement work. This rule effectively extends Occupational
Safety and Health Administration (OSHA) worker-protection require-
ments for asbestos abatement to State and local employees who
perform asbestos abatement work.
OSHA is normally responsible for the Federal regulations
protecting workers, but the Occupational Safety and Health Act
does not give it authority to cover State and local government
employees. However, 23 States and territories have set standards
for State, and local employees that are at least as strict as
OSHA's worker-protection rules. In addition, EPA decided that
four other States,. Idaho,. Kansas,. Oklahoma- and Wisconsin, have.
regulations that-are comparable to or more stringent than its rule..
The EPA final regulation thus applies to the remaining 23 States only.
The EPA regulation is similar to.; the. exist-ing OSHA. standard'-in
both the exposure 1imits it establishes and the maximum concentration
it allows at any one time. It also requires work practices such as
wetting of asbestos, use of personal protective equipment and provision
of special clothing. Furthermore, it requires environmental monitoring,
the posting of caution signs, cleanup, and proper disposal of'asbestos
waste, as well as medical examinations for certain employees and the
retention of medical examination and environmental monitoring records.
However, the EPA rule does not cover routine repair of less than three
linear or three square feet of friable asbestos material. Thus, minor
routine repairs of pipe insulation by sealing or taping would be
exempt.
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In January 1986, EPA proposed a rule under section 6 of TSCA
to ban the manufacture, import and processing of certain asbestos
products. The Agency also proposed to phase out asbestos use in
other products, and to require labeling of any product that
contains asbestos and is not banned. Labeling would ensure that
persons working with the products would know they contain asbestos,
and enable them to reduce the likelihood of exposure.
Under section 6, EPA proposed to prohibit five asbestos products:
roofing felts, flooring felts, vinyl-asbestos floor tile, asbestos
cement pipe and fittings, and asbestos clothing. In addition, all
remaining domestic mining and importation of asbestos would be
phased out over a 10-year period. The 10-year phase out that
affects other products would be accomplished via a transferable
permit system, under which EPA would allocate permission to mine
or import, a specific volume of asbestos per year.
EPA is considering additional approaches to address the
risks associated with asbestos products, including the ban of
categories of asbestos products, such as asbestos construction
products and .asbestos friction products, at staged intervals.
In encouraging the development of substitutes, EPA is
promoting a significant reduction in risk. The products that
are currently replacing asbestos appear to present lower risk.
However, EPA will monitor the development of substitutes, and
will use TSCA to require that the substitutes be tested, if that
measure seems necessary to ensure their safety.
In August 1986, EPA published an advance notice of proposed
41
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rulemaking soliciting comments on the future direction of its
program to reduce risks from asbestos in schools. EPA currently
uses guidance and technical assistance, with limited Federal
regulation, to motivate schools to abate asbestos risks. EPA is
considering whether to continue with the status quo or to
implement its current approach more aggressively or to selectively
incorporate a greater emphasis on Federal regulation. After
review of these comments, EPA may propose further regulatory
requirements under section 6(a) of TSCA. In FY 1987, EPA expects
either to propose additional Federal regulations or publish reasons
why it believes additional regulations are not. necessary..
The study, "Evaluation of Asbestos Abatement Techniques;
Phase I: Removal", completed in FY 1986, concluded that it is
possible both to remove asbestos-containing material from a school,
and to achieve 'low'airborne levels after that- removal, by means of
post-reTnoval cleanup., EPA selected four schools in-one suburban
school district for the study because the district was already
committed to an asbestos removal program. The study also concluded
that transmission electron microscopy (TEM) provides the clearest
documentation of changes in airborne asbestos levels. Two other
analytical methods in addition to TEM, scanning electron microscopy
and phase contract microscopy, were studied.
The study, "Evaluation of Asbestos Abatement Techniques;
Phase II: Encapsulation With Latex Paint," was published in FY
1986. The study concluded that high airborne asbestos levels can
occur within the work site during encapsulation and that airborne
42
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asbestos levels can be significantly reduced after encapsulation
of asbestos material, although it is impossible to predict how
long this reduction will last. Because airborne asbestos levels
can be high within the work area during encapsulation, containment
barriers should always be used to prevent contamination of the
rest of the building, and workers involved in the project should'
wear respirators for protection while in the containment area.
Air samples for this field study were collected at a variety
of sites in a suburban school undergoing encapsulation with latex
paint. The samples were analyzed with Transmission Electron
Microscopy.
In the "Asbestos Abatement Efficacy Study—Phase III", air
level samples were monitored in schools with students present to
determine the effectiveness of the asbestos removal that had taken
.place-during the previous summer. Sampling was completed in
November 1985; results will be published in FY 1987;
EPA completed a random sampling scheme for friable surfacing
materials in buildings. The scheme is contained in the document,
"Asbestos in Buildings: Simplified Sampling Scheme for Friable
Surfacing Materials." Pertinent statistical support is detailed
in the document, "Statistical Support for Asbestos in Buildings:
Simplified Sampling Scheme for Friable Surfacing Materials."
EPA also finalized "Measuring Airborne Asbestos Following an
Abatement Action." This guidance document discusses methods for
determining when an asbestos abatement project has been completed
43
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satisfactorily, a process which involves both air monitoring and
sample analyses.
ASHAA Effective in FY 1986, Congress included tough new restrictions
Asbestos
Activities for Federally-funded asbestos work in schools. Now all on-site
supervisors and a majority of the hired asbestos abatement workers
must either be State-certified or have attended EPA-approved
asbestos abatement training courses.
With these restrictions in place, Congress appropriated $50
million in FY 1986 under the Asbestos School Hazard Abatement Act
(ASHAA) to aid those primary and secondary schools with a severe
asbestos hazard who cannot afford to abate the hazard on their own.
EPA- awarded $47'million in grants and loans to 173 of the Nation's
neediest public and private school districts, to help perform 421
asbestos abatement projects in 295" schools.. All of the-1,777
schools that applied. for ASHAA funds in 1986 were- ranked on a
national scale, based on the extent of the health hazard the friable
asbestos posed to students and employees. EPA decided how much
money each school district was to receive on the basis of that
ranking. Each school authority then decides on the most effective
remedy: removal, encapsulation or enclosure of the asbestos. Most
of the EPA-supported schools chose asbestos removal. The legislation
has authorized EPA to spend $600 million over seven years to abate
asbestos in qualifying schools.
Fourteen States already have certified programs for
contractors; within a year an additional nine States should have
44
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qualified certification programs. Meanwhile, EPA is funding the
National Association of Minority Contractors to conduct training
in New York City, Detroit, and Los Angeles. These courses will
be EPA-approved, and will meet the congressional requirement.
In 1986, EPA approved a number of asbestos abatement
training courses for supervisors and workers. EPA-funded training
facilities are located in (Georgia Tech) Atlanta, (University of
Kansas) Kansas City, (Tufts) Boston, (the University of Illinois)
Chicago, (the University of Texas) Arlington, TX, (the University
of Utah) Salt Lake City, (Drexel University) Philadelphia, and
(Rutgers University) Piscataway, NJ. The University of California
at Berkeley is funded by EPA to offer EPA-approved courses. EPA
expects to begin approving other courses for the ASHAA program
within the next few months. The National Asbestos Council (NAC)
and the Committees on Occupational: Safety and Health also have
received EPA approval and are receiving Agency funds to conduct
abatement worker training courses. These programs are designed
for nonsupervisory workers in the abatement industry. NAC can
send field personnel to a particular project location for on-site
training.
Under the ASHAA program for contractors in States without
training requirements, a training course that has been approved by
any State certification and training program is an EPA-approved
course. For example, the Association of Wall and Ceiling Industries
(AWCI) training course is approved by Alabama. As a result, the
AWCI course is acceptable not only in Alabama, but also in any
45
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other State that has no certification and training programs.
Referrals
In FY 1986, the EPA Administrator signed separate agreements with
the heads of two other Federal agencies to enhance interagency
control of toxic substances. These agreements coordinate and
streamline the way TSCA section 9(a) actions are handled by EPA,
the Occupational Safety and Health Administration (OSHA) and the
Consumer Product Safety Commission (CPSC).
The intent of the two memoranda of understanding is to promote
more efficient EPA administration of TSCA section 9(a) actions, in
order to better conform with the responsibilities of OSHA and
CPSC. EPA, OSHA and CPSC have different, though related,
responsibilities and objectives with regard to.toxic substance
control. In order to regulate a toxic substance under TSCA, EPA
must make a finding of unreasonable risk -of injury to health or
the environment. The Occupational Safety and Health Act, enacted
in 1970, requires OSHA to demonstrate that there is a significant
risk to employees from a substance in the workplace, in order
to regulate it. CPSC administers three laws that could be used
in certain circumstances to address those risks that EPA would
otherwise process under TSCA. These acts are the Consumer Product
Safety Act, the Federal Hazardous Substances Act and the Poison
Prevention Packaging Act.
1,3-Butadiene
In October 1985, EPA referred 1,3-butadiene to OSHA for regulatory
46
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consideration. EPA presented its conclusion that the manufacture
of 1,3-butadiene and its processing into polymers presents an
unreasonable risk of cancer to workers. EPA has determined that
this risk may be prevented or reduced to a sufficient extent if
action is taken under the Occupational Safety and Health Act.
Glycol Ethers
In FY 1984, EPA initiated a regulatory investigation under TSCA to
explore the^need for reducing worker exposure to two glycol ethers,
2-ethoxyethanol and 2-methoxyethanol, and their acetates. Studies
indicated that glycol ethers produced adverse reproductive and
developmental effects in animals at low doses.
The Agency determined that a workplace standard of the same
type as the current OSHA standard can sufficiently reduce risk for
workplace settings where glycol ethers are used, manufactured,
formulated or processed. In May 1986, EPA -referred the class- of
glycol ethers to CPSC under the authority of TSCA section 9(a),
Toluenediamine
In July 1986, EPA announced termination of its investigation of work-
place exposure to toluenediamine (TDA). In accordance with TSCA
section 9(d) EPA transmitted to OSHA its public record pertaining
to this issue. EPA made this decision because the chemical's
potential risks in the workplace are properly a matter of concern
for OSHA. Subsequently, EPA issued a Chemical Advisory to inform
manufacturers who use TDA that it is a probable human carcinogen.
The Chemical Advisory also suggests ways to reduce worker exposure.
EPA will continue to investigate the environmental hazards posed
47
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by IDA in non-occupational settings.
4,4'-Methylene Bis(2-ch1oroani1ine) (MBOCA)
In June 1986, EPA announced termination of its regulatory investi-
gation of MBOCA, which had begun in May 1983. EPA transferred its
public file on the chemical to OSHA, in accordance with section
9(d) of TSCA. OSHA has statutory authority to prevent, or reduce
to a significant extent, the risks associated with the processing
and use of MBOCA in the workplace. OSHA has been kept informed of
EPA activities during the latter's regulatory investigation of
this chemical. EPA had previously issued a Chemical Advisory to
all MBOCA processors-in tha United. States., The-Agency also issued
a TSCA section 8 reporting and recordkeeping rule which requires
persons to notify EPA if they currently are manufacturing MBOCA in
this country,, or if they begin-manufacturing the-substance or
alter their method of manufacture-.in the future.. The rule excludes
importers from its reporting requirements. It enables EPA to
evaluate activities which may result in exposure to MBOCA, and to
take followup regulatory action, if necessary, to reduce risk to
human health or the environment.
Formaldehyde
In May 1984, EPA determined under section 4(f) of TSCA that exposure
to formaldehyde may pose significant risk of widespread harm to the
large number of persons who either live in mobile and conventional
homes made with urea-formaldehyde wood products, or who manufacture
apparel from fabric treated with formaldehyde-based, durable-press
resins.
48
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In March 1986, EPA published a notice announcing that the Agency
was ending its investigation of the risk posed by formaldehyde exposure
in the workplace, including the risk to manufacture apparel workers,
and was sending the information it had developed to OSHA. Uith respect
to the risks posed by exposures in mobile and conventional homes, a
risk assessment document was prepared in FY 1986; regulatory options
will be considered early in FY 1987.
Chloromethane
In May 1986, EPA referred chloromethane to OSHA, under TSCA section
9(d), for consideration of potential carcinogenic and systemic toxicity
risks at the current OSHA Permissible Exposure Limit (PEL).
Signifi- Once a final SNUR (TSCA section 5{a)(2)) for a substance is issued,
cant
New Use a person who intends to manufacture, import or'proeess the
Rules ...
• substance for a significant new use is required to. notify EPA at
least 90 days before beginning such activity. A substance listed
in a SNUR is generally subject to the same statutory procedures as
those required under TSCA's PMN rule for a new chemical substance.
The purpose of the SNUR notice requirement is to furnish EPA with the
opportunity to evaluate the intended use of the substance and, if
necessary, give the Agency enough time to prohibit or limit the
use before its inception.
PBBs and Tris
EPA proposed a SNUR for eight polybrominated biphenyls (PBBs)
and for tris 2,3-dibromopropyl phosphate, also known as Tris.
49
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In this proposed rule, EPA indicated that any use or related
activities involving PBRs or Tris may result in significant
human or environmental exposures. Even though these substances
are listed on the TSCA Inventory, EPA is not aware of any use of
them in the United States since at least 1980. In 1977, EPA
began to investigate the need to control PRRs and Tris under
TSCA. In 1980, EPA issued a TSCA section fl(a) rulp reguiring
submission of a Notice of Manufacture or Importation for PB^s
and Tris. That rule included a "sunset provision" that terminated
the reporting requirements for those chemicals by May 1, 19RB.
Since then, EPA has reassessed the toxicity of PRRs and Tris, past
and present exposure, and the need for further information about
these chemicals. The Agency decided a SNUR would provide the
information.
1,2,3,4,7,7-Hexachloronorbornadi pne
In November 1985, EPA issued a final rule reguiring certain
manufacturers, importers, and processors of 1,?,3,4,7,7-hexachlorn-
norbornadiene (Hex-RCH) to submit a section 8(aj report; and other
manufacturers, importers, and processors of Hex-BCH to submit a
significant new use notice under section 5(a)(2). The reports
and notices will allow EPA to monitor the volume of Hex-RCH
manufactured, imported, and processed; the number of individuals
exposed; the manner of environmental release; and the method of
disposal. EPA will evaluate the reported information to determine
if further regulatory action is appropriate.
50
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11-Aminoundecanoic Acid
In July 1986, EPA. proposed a SNUR to require manufacturers,
importers, and processors of 11-aminoundecanoic acid (11-AA) to
submit a significant new use notice for any use except as an
intermediate in the manufacture of nylon 11 in an enclosed process.
At the same time, EPA also proposed, under TSCA section 8(a),
that manufacturers, importers, and processors of 11-AA who are
not covered by the SNUR notification requirements notify EPA of
prospective manufacture, import, or processing of this substance.
Both requirements would provide EPA with the -information needed
to determine if further regulatory action is warranted to control
exposure.
HMPA and Uretnane
EPA issued a final SNUR for two substances, hexamethylphosphoramide
(HMPA) and urethane, because they are expected to be hazardous
to health, and their use may result in significant human and
environmental exposures. Both substances are known animal
carcinogens and suspected human carcinogens. Neither substance
has been imported into the United States, nor manufactured
nor processed here, for some time. The SNUR requires that any
person who intends to manufacture, import or process either
substance for any use must submit a significant new use notice to
EPA.
Pentachloroethane
EPA proposed and promulgated a SNUR to require persons to notify
51
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the Agpncy at least 90 days before beginning the manufacture,
import, or processing of pentachl.oroethane for any use. At one
time, pentachloroethane was used as an intermediate in the production
of tetrachloroethylene. The Agency believes that initiation of a
significant new use of pentachloroethane could result in significant
human exposure. The rule will furnish FPA with information needed
to evaluate an intended use, and allow the Agency to take steps to
protect against potentially adverse exposures to this substance
before such exposures can occur.
^
Methyl n-Rut.yl Ketone (MRK)
In July 19Sfi, FPA proposed a SNUR for methyl n-butyl ketone- (MRK).,
EPA believes M5K can cause neurotoxic effects in humans, and any
use of it may result in significant human exposure. The substance
has been* used as' a solvent" for lacquers and in lacquer and varnish
removers.. MRK also.has been used as a sol vent. for-'Oi Is,..fat's1 and
waxes'. In 1979, the1 only known- MBK manufacturer in the- United
States discontinued production of the substance and sold the last
of its inventory in 1981. MRK is not now being imported into the
United States.
Chemical EPA uses Chemical Advisories to inform individuals or organizations
Advisories
about toxic effects of certain chemicals, exposures which are of
concern, and alternative methods of reducing risks. They are
developed after consultation with interested parties, including
companies, public interest groups, and other agencies. Chemical
Advisories are designed to he used where increased awareness of
-------
potential risk is likely to lead to meaningful precautions, and
are addressed and.distributed to individuals or organizations for
whom the information is most useful. They are intended to encourage
voluntary risk reduction actions by individuals or organizations
in instances where regulatory control is not appropriate, or as
interim measures while regulatory action is pursued.
In FY 1986, two Chemical Advisories were issued, addressing
hazards from burning used motor oil and 2,4-toluenediamine. The
Chemical Advisory on burning used motor oil addresses the problem
of potential exposure to lead and other combustion products from
improperly vented space heaters. Small workplaces, such as garages
and service stations, often heat by burning used oil drained from
gasoline-powered engines. This oil contains lead that has been
deposited in the engine as a by-product of fuel combustion. When
the used oil is burned in undented heaters', lead in the exhaust
gases enters the workplace air. Excessive lead levels in inhaled
air can cause toxic effects in humans, including nerve and irreversible
brain damage, kidney failure, anemia, high blood pressure, various
blood and metabolic disorders and gastrointestinal disturbances.
Lead particles may also be deposited on workplace surfaces. These
particles can be ingested inadvertently, increasing the total
exposure. The Advisory was distributed in November 1985 to com-
plement a proposed rule by the Office of Solid Waste, under the
Resource Conservation and Recovery Act (RCRA). As proposed, that
rule would ban burning used oil in unvented space heaters.
53
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The second Chemical Advisory, completed in September 1986,
advises .manufacturers of products that contain 2,4-toluenediamine
to minimize worker exposure to these products. 2,4-Toluenediamine
causes cancer in laboratory animals and is considered by EPA to be
a probable human carcinogen. This Advisory also suggests ways to
reduce exposure. Workers may be exposed to TDA by inhalation or
.ingestion of vapors or particles, and by skin contact. TDA is
shipped and handled in either molten or solid state. When molten
TDA is handled, any vapors which escape into workplace air may
condense into fine particles and be deposited on clothing or on
work surfaces,, making them available-for absorption through the
skin. TDAs in the solid state have low vapor pressure and do not
normal'ly present an inhalation hazard.
54
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5. CHEMICAL TESTING PROGRAM
Program Data obtained through testing are used by EPA and others to determine
Status
whether and how to regulate or control potentially hazardous chemicals.
Section 4 of TSCA gives EPA the authority to require manufacturers or
processors of chemicals to test for certain health 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 data, and who is responsible for
conducting the testing. To require testing EPA must find that a
chemical may present an unreasonable risk, that there are insufficient
data available with which to reasonably determine or predict the
effects of the chemical, and that testing is necessary to generate
such data. A test rule may also be based on an EPA finding of
substantial production and exposure to humans and the environment.
In June 1986, EPA issued an Interim Final Rule that amended
the existing regulations for the development-and implementation of
testing requirements under section 4 of TSCA. The amendment
establishes procedures for using enforceable consent agreements to
require testing under section 4. This rule will allow EPA to
negotiate with manufacturers, processors, and other interested
parties to establish testing programs that satisfy EPA testing
needs. An enforceable consent agreement may be adopted in a case
where consensus on an industry test program is reached in a timely
manner by EPA, affected manufacturers, processors, and other
interested parties. If timely consensus cannot be reached or
55
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appears unlikely, EPA will invoke the pertinent rulemaking procedure,
as specified in the Act. The Agency believes the consent agreement
process will lead to the development of necessary test data
significantly earlier than formal rulemaking.
The Interagency Testing Committee (ITC) continues to designate
chemicals to EPA for priority testing. The ITC is comprised of
appointed members from eight Federal agencies, as specified in
TSCA. Representatives from six additional Federal agencies serve
in a liaison capacity. EPA must respond to chemical designations
within twelve months either by initiating rulemaking or by giving
reasons for not so doing. The ITC may designate up to 50 chemicals
or categories of chemicals for testing; it must consider revising
its' list, and report to EPA at least every six months.
To date, the use of section 4 authority to obtain data
through testing has been primarily in response to ITC-designated
and recommended chemicals; however, two new. uses of this' authority
were introduced in FY 1986. First, EPA developed a test rule in
response to a citizens' petition filed under section 21 of TSCA.
The proposed test rule would require manufacturers and importers
of fourteen commercial organic chemicals to test these substances
for the presence of chlorinated and brominated dioxins. EPA will
ultimately issue a decision that indicates either that no further
action is warranted, or that regulatory action is warranted in the
form of controls to limit the amount of these materials manufactured
and released. Second, EPA developed a test rule in support of
priority data development activities of another Agency program,
56
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the Office of Air Quality Planning and Standards. In 1985,
1,1-dichloroethylene was considered for regulation as a potentially
toxic air pollutant under the Clean Air Act, but available
information was insufficient at that time to support a decision to
regulate. The Agency proposes to obtain the data needed to better
assess the chemical's oncogenic potential via section 4.
Test Rule In FY 1986, EPA took a total of 38 ITC-related actions.
Development
Of these, 12 were responses to new ITC designations, and 26
were post-initial response determinations. These produced 13
proposed rules, 9 final rules, 10 proposed test standards,
and 6 decisions not to test. Other testing actions produced an
additional 4 proposed rules. Table. 4 presents a summary of all
testing actions taken in FY 1986.
57
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Date
Table 4
Summary of Chemical Testing Actions
Testing in Response to the Interagency Testing Committee (ITC)
Chemical Action ITC List
08/26/85 2-Chloro-l,3-butadiene
(Chloroprene)
10/18/85 4-Chlorobenzotri f1uoride
10/30/85
Octamethylcyclo-
tetrasiloxane
1.1/06/85 Cumene
11/06/85 Mercaptobenzothiazole
Decision Not. to Test; 15
available data are sufficient;
EPA is not requiring environ-
mental effects or chemical
fate testing at this time.
Decision Not to Test; data 9
available to the Agency,
including data received
pursuant to a negotiated
testing agreement, are
adequate for health,
environmental, and chemical
fate effects; no further
testing is required.
Notice of Proposed Rulemaking; 15
proposes that manufacturers and
processors conduct chemical fa.te
and. environmental effects tests;
Notice of Proposed Rulemaking; 15
proposes that manufacturers and
processors perform testing for
pharmacokinetics, subchronic
toxicity, oncogenicity,
mutagenicity, neurotoxicity,
developmental toxicity and
reproductive toxicity; if
triggered, acute and chronic
aquatic toxicity in saltwater
and freshwater fish and
invertebrates, and biodegrada-
tion and volatilization from
water.
Notice of Proposed Rulemaking; to 15
perform chemical fate and environ-
mental effects testing including
persistence and mobility, chronic
aquatic toxicity, pharmaco-
kinetics, developmental toxicity,
reproductive toxicity, neuro-
toxicity and chromosomal
aberrations.
58
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11/06/85 Anthraquinone
11/06/85 Sodium N-Methyl-N-
Oleyltaurine
11/06/85 Fluoroalkenes
11/13/85 Pentabromoethylbenzene
U/27-/85 Propylene Oxide
11/27/85 Propylene Oxide
12/19/85 1,1,1-Trichloroethane
12/20/85 Mesityl Oxide
12/20/85 Mesityl Oxide
59
Notice of Proposed Rulemaking; to 15
perform testing for water
solubility, bioconcentration
and acute toxicity to aquatic
organisms. Testing for bio-
degradation and chronic toxicity
of aquatic organisms, will be
required if the acute toxicity
or bioconcentration test results
and the annual production and
importatioQ level meet specified
criteria.
Decision Not to Test; existing 15
information on health effects
does not suggest potential for
an unreasonable risk at expected
exposure levels.
Notice of Proposed Rulemaking; 7
to perform health effects
testing of vinylidene fluoride,
vinyl fluoride, hexafluoropropene,
and tetrafluoroethane.
Notice of Proposed Rulemaking; 1R
to perform testing for chemical
fate and environmental effects.
Notice of Proposed Rulemaking- 1
Test Standards; proposes TSCA
test guidelines for develop-
mental toxicity be used as test
standard for the required study
and that test data be submitted
within a specified time frame.
Notice of Final Rulemaking; 1
requires developmental toxicity
testing.
Notice of Final Rulemaking; 3
promulgates testing in accordance
with proposed test standards and
reporting requirements.
Notice of Proposed Rulemaking- 4
Test Standards; proposes that
certain TSCA test guidelines be
used as test standards for the
required studies and that test
data be submitted within specified
time frames.
Notice of Final Rulemaking; 4
requires testing for chronic effects,
mutagenicity, and oncogenicity if
triggered from mutagenicity test
results.
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12/30/85 Hydroquinone
12/30/85 Hydroquinone
12/30/85 Quinone
01/06/86 Phenylenediamines
(o-f m-, p-)
02/27/86 Formamide
03/27/86 Ethyltoluenes
03/27/86 Trimethyl benzene
Notice of Proposed Rulemaking- 5
Test Standards; proposes that
certain TSCA test guidelines and
industry-submitted guidelines be
used as the test standards for the
required studies and that test
data be submitted within specified
time frames.
Notice of Final Rulemaking; 5
requires testing for reproductive,
teratogenic and nervous system
effects and that the chemical's
toxicokinetics be evaluated.
Decision Not to Test; data 5
received in response to the
proposed rule indicate human
and environmental exposure to
quinone are so low as to be
unlikely to present an unreason-
able- risk to-humans or the
environment.
Notice of Proposed Rulemaking; 6
proposes testing of 0-, m-, p-POA
for their chemical fate and
environmental toxicity and. m-PDA
for mutagenic effects and oncogenic.
effects if triggered by
mutagenicity test results.
Decision Not to Test; data 10
available, includi-ng data received
pursuant to a negotiated testing
agreement, are adequate to character-
ize formamide for health effects;
no further testing is required at this
time. EPA may propose rulemaking to
monitor any significant change in
exposure to the chemical.
Notice of Proposed Rulemaking-
Test Standards; proposes that
protocols submitted by the
American Petroleum Institute, with
minor additions as proposed by
EPA, be adopted as test standards;
establishes schedules for the
testing.
10
10
Notice of Proposed Rulemaking-
Test Standards; proposes that
protocols submitted by thfe
American Petroleum. Institute, with
minor additions as proposed by
EPA, be adopted as test standards;
establishes schedules for the testing.
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04/07/86 Chlorinated Benzenes
(Environmental)
04/07/86 Chlorinated Benzenes
(Environmental)
04/10/86 Diethylenetriamine
04/28/86 Cresols
04/28/86 Cresols
05/15/86 'Methylcyclopentane
05/15/86 Tetrabromobisphenol A
05/15/86 Triethylene Glycol
Monomethyl Ether
05/15/86 Triethylene Glycol
Monoethyl Ether
Notice of Proposed Rulemaking- 1,3
Test Standards; proposes that
certain TSCA test guidelines be
used as the test standards for
the required studies and specifies
time frames for test submissions.
Notice of Final Rulemaking; 1,3
promulgates EPA's decision to
require environmental effects
and chemical fate testing.
Notice of Proposed Rulemaking- 8
Test Standards; proposes the
adoption of study plans and
schedules fate testing.
Notice of Proposed Rulemaking- 1
Test Standards; proposes that
certain TSCA test guidelines be
used as the test standards for the
required studies and specifies
time frames for test submissions.
Notice of Final Rulemaking; 1
requires mutagenic effects,
developmental t-oxicity, and
reproductive .effects testing/
studies.
Notice of Proposed Rulemaking; 16
to perform testing for neuro-
toxicity, subchronic toxicity,
and inhalation and dermal
pharmacokinetics.
Notice of Proposed Rulemaking; 16
to perform testing for chemical
fate and environmental effects.
Notice of Proposed Rulemaking; 16
to perform subchronic toxicity,
developmental toxicity, neuro-
toxicity, mutagenicity, repro-
ductive toxicity, and onco-
genicity testing.
Notice of Proposed Rulemaking; 16
to perform subchronic toxicity,
developmental toxicity, neuro-
toxicity, mutagenicity, repro-
ductive toxicity, and onco-
genicity testing.
61
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05/15/86
Triethylene Glycol
Monobutyl Ether
07/08/86
Chlorinated Benzenes
(Health)
07/10/86 Biphenyl
U/
i eurdi.ii i uruueruene
08/04/86
2-(2-Butoxyethoxy)-
ethyl acetate
09/09/86 1,2-Dichloropropane
Notice of Proposed Rulemaking; 16
to perform subchronic toxicity,
developmental toxicity, neuro-
toxicity, mutagenicity, repro-
ductive toxicity, and onco-
genicity testing.
Notice of Final Rulemaking; 3
requires manufacturers and
processors to conduct
cfhcogenicity testing of 1,2,4-
TCB; reproductive effects testing
of MCB, 1,2- and 1,4-DCBs; repro-
ductive effects and developmental
toxicity testing of 1,2,4,5-TCB.
This action also terminates rule-
making process for subchronic/
chronic and oncogenicity testing
of 1,2,4,5-TCB.
Notice of Proposed Rulemaking- 10
Test Standards;, proposes that
industry-submitted study plans
and schedules be adopted, with
certain revisions, as the test
standards and reporting
deadlines for the required
testing..
Decision Not to Test; announces 3
EPA is not at this time continuing
rulemaking~to require environ-
mental effects testing.
Notice of Proposed Rulemaking; to 13
perform health effects testing
for subchronic toxicity; neuro-
toxicity/behavioral effects;
developmental neurotoxicity;
pharmacokinetics; mutagenicity;
oncogenicity and dermal absorp-
tion testing.
Notice of Proposed Rulemaking- 3
Test Standards; proposes that
pharmacokinetic testing be con-
ducted using TSCA test guidelines
for the required studies and that
test data be submitted within
specified time frames.
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09/09/86 1,2-Dichloropropane
09/18/86 Bisphenol A
Notice of Final Rulemaking;
requires manufacturers and
processors to test for neuro-
toxicity, mutagenicity, repro-
ductive effects, developmental
toxicity, as well as acute and
chronic toxicity to aquatic
invertebrates and acute toxicity
to algae.
Notice of Final Rulemaking;
requires manufacturers and
processors to conduct a
90-day inhalation study with
particular emphasis on pul-
monary effects. EPA is ter-
minating the test rule process
for acute and chronic aquatic
toxicity testing.
14.
Other Testing Actions
12/19/85 Polyhalogenated
Dibenzo-p-di.oxins/
Oibenzofurans
05/15/86 Commercial Hexane
08/04/86 Diethylene Glycol Butyl
Ether
Notice of Proposed Rulemaking;
requires manufacturers and
importers of 14 commercial
organic chemicals to test for
the presence of chlorinated and
brominated dioxins and furans.
Testing would also be required
on 20 other organic chemicals
(not now commercially manufactured
in the U.S. or imported) if
manufacture or importation resumes.
Notice of. Proposed Rulemaking;
to perform testing for acute and
subchronic toxicity, oncogenicity,
reproductive toxicity, develop-
mental toxicity, mutagenicity,
neurotoxicity, and inhalation and
dermal pharmacokinetics.
Notice of Proposed Rulemaking; to
perform health effects testing for
subchronic toxicity; neurotoxicity/
behavioral effects; developmental
neurotoxicity; pharmacokinetics;
mutagenicity and oncogenicity.
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08/12/86 1,1-Dichloroethylene
Enforceable
Consent
Agreements
Quality
of Data
Notice of Proposed Rulemaking; to
conduct distribution, excretion and
metabolism (DRM) studies and a two-
year inhalation oncogenicit.y Mnassa.y,
Oncoqenicity testing would be delayed
until after DEM data Have been
completed and evaluated.
To initiate the enforceable consent agreements neootiation
process, EPA publishes a solicitation of interested parties
in the Federal Register which 1) announces its tentative
evaluation of testing needs for a given chemical, ?) announces
a public meeting to discuss such testing,, and 3) requests all
persons desiring to have the status of "interested parties"
in any negotiations on the-chemical to notify EPA of their
interest. Since publication of the Interim Final Rule, FPA
has published such solicitations on two ITC-designated chemicals, -
two'non-ITC designated chemicals and one'chemical cateoory..
In order to maintain *~he scientific integrity of EPA's' decision-
making regarding the regulation of chemicals, the Agency pursues
a rigorous program to ensure the quality of the data received as a
result of test requirements meeting established criteria. In FY
1984, the Agency promulgated Rood Laboratory Practice (GI..P) standards
(48 FR 53922-53944, November 29, 1983). The RLPs specify procedures
for conducting health effects and environmental effects testing
under TSCA, and requirements for facility operations, maintenance
of equipment and recordkeeping. To ensure compliance with the GLP
standards and with testing requirements under TSCA and FIFRA, FPA's
•
Office of Compliance Monitoring is responsible for conducting
fi4
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laboratory inspections, and for auditing completed test studies.
Inspection staffs are drawn from EPA headquarters, Regional Offices,
and from the Food and Drug Administration (FDA). The Office of
Toxic Substances 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
audits and.review test data resulting from ongoing industry testing
and test rules. Inspection and study audit reports from EPA
Regional and Headquarters Inspectors are reviewed, and regulatory
actions recommended as appropriate.
In FY 1986, 16 laboratory inspections were conducted and 65
test studies were audited under section 4 testing authority. See
Chapter 7 for detailed compliance and enforcement actions.
Test Section 4 of TSCA also requires the-development and annual review
Guidelines •
of test standards and guidelines.. Tb ensure consistency and
scientific quality, all new guidelines are peer-reviewed by
scientists and experts within the Agency and in the academic
community, State and Federal agencies, public interest groups, and
industry.
During FY 1986, EPA published one new test guideline,
"Indirect Photolysis - Screening Level Test", and published revisions
to 37 guidelines.
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6. SUPPORT TO OTHER PROGRAMS, REGIONS, AGENCIES, STATES, INDUSTRY
Program The Office of Toxic Substances (OTS) made a major effort in FY
Status
1986 to inform other EPA program offices and regional offices,
other Federal agencies, and States about the chemical information
collected under TSCA sections 4, 5 and 8; about potential uses
of TSCA in filling information or control gaps that cannot be
obtained through other legislative authorities; and about the
technical expertise (i.e., risk assessment, structure activity,
modeling) that is available for cross-media activities. Since
many other programs address priority chemical exposure problems,
OTS feels that these programs can benefit greatly from its
unpublished health and safety information, and from its
>xpertise. Several activities have been discussed in the
previous chapters [i.e., in Chapter 4, CAIR, section 8(d)
information gathering, CEPP; and in Chapter 5, test rule develop-
ment support]; however, additional significant accomplishments
cannot be categorized under a specific program. These are
discussed in this chapter.
Two formal mechanisms were established to assess the
needs of other program offices and to determine how to best
meet these needs. The Committee for Programs' Regulatory Use
of TSCA examines potential uses of TSCA, uses of OTS technical
expertise by other programs, and the potential impacts of both
on existing OTS programs. The Testing Priority Committee
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(TPC) examines the technical merits of program offices' requests
for testinq under TSCA. The TPC has established a standing procedure
for the nomination of chemicals, satisfying multiple proaram needs,
for testing under TSCA as well as other testing mechanisms. In
addition, the TPC serves as a forum for information exchange with
respect to ongoing and planned testing.
INFORMATION
DISSEMINATION
Chemical
Assessment
Desk
TSCATS
OTS has collected a wealth of unpublished data on chemicals as a
result of various section a and 8 rules, and has gained much exper-
ience in evaluating new and existing chemicals (i.e., hazard,
exposure, source, risk assessment, modeling). OTS makes its
information and expertise available through the activities
below, and is continuina to explore methods to. enhance the
accessibility of TSCA data to outside users.
The Chemical Assessment Desk pilot project was introduced in ^arch
to provide consultation on chemical toxicity and exposure potential,
based on available OTS information and evaluations plus information
from other EPA programs. The project's initial client, Region 8,
has referred approximately 20 issues to the Chemical Desk to
date. In August 198fi, the pilot project was expanded to include
Region 10. Regions 1, 4, and 9 will be added by the end of
calendar year 1986.
In December 1985, EPA. implemented the Toxic Substances Control
Act Test Submissions (TSCATS) data base, which is an online
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index to tne compiled unpublished health and safety studies
that have been submitted to EPA from chemical manufacturers and
processors. This is non-confidential information that can be
made available to the public. Users include Federal and State
agencies, researchers, risk assessors, trade and professional
associations, and toxicologists. The data base contains over
10,000 citations that cover more than 1,?00 unique chemical
substances. Used in conjunction with published material,
the data can help formulate hazard evaluations and risk
assessments.
GF.MS The Office of Toxic Substances has several information and
model ing-systems available to hplp States deal" w-ith their toxic-
related problems and projects. Among the most, important is the
Graphical Exposure Model ing System. (GFMS"), which features
chemical property .estimation and- envi ronmenfal partitioning
fate, and exposure models, and draws upon a wide range of demo-
graphic and environmental characteristics data.
Videos In FY 198fi, FPA produced 4 videos to provide the public with
information, clarification, or guidance on TSCA regulations.
TSCA Inventory Update: An Overview for Chemical Manufactures
and Importers was produced as an instructional videotape to aid
persons required to report during the partial updating of the
TSCA Inventory. TSCA: Balancing Risks and Benefits was produced
to provide general information on TSCA's preventive risk/benefit
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INDUSTRY
COLLABORATION
approach, review of new chemicals before they are in commerce,
information-gathering on chemicals of concern, and related issues.
The videotape is designed to explain the Act to public health
organizations, State governments, labor oraam'zations, public
interest groups, a.nd'universities or secondary schools. Deducing
the Risks of PCBs explains the history of PCB regulation under
TSCA, and the effect of PCBs on health and the environment. The
video also focuses on the general requiregents of the rules,
including disposal requirements, registration of PCB transformers
with fire departments, notification of huildinq owners, and
the filiag of an annual inventory report. This tane is dpsianed
to explain PCBs to the utility industry, fire departments,
building owners, and scrap and salvage Hpalers. npn't Blow It!
was produced for brake and fleet garaqe mechanics and vocational
schools; it provides information on potential health
hazards from exposure to asbestos in brake dust, as well as
step-hy-step methods to effectively control brake dust.
A February 19P6 workshop reviewed the methods currently
available to assess workplace exposures to chemicals, given limited
data only. The workshop convened EPA, industry, and academic
representatives to address concerns about inhalation exposure,
dermal contact, engineering controls, and respiratory protection.
For many participants, the workshop served to clarify thp
regulatory, temporal, and economic limitations under which FPA
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operates its new chemicals program. The workshop also enabled
EPA to draw upon considerable external expertise to help advance
the technical tools and procedures the Agency uses to assess
new chemicals and workplace exposures.
Another example of industry collaboration was a national
conference on risk communication held in January 1QP6. The
conference was co-sponsored by the Conservation Foundation, the
National Science Foundation, the American Industrial Health
Council, and the University of Southern California. Government,
industry, environmental, and consumer leaders discussed new
and practical ways to communicate about health, safety, and
environmental risks from hazardous wastes, nuclear energy, and
pesticides.
TECHNICAL
EXPERTISE
In addition to providing test rule development and data-gathering
support, OTS made its expertise available to other EPA programs.
One particular example of a unique scientific expertise OTS
possesses is the Office's ability to evaluate the potential
hazards of chemicals for which adequate test data are lacking.
Through its experience in assessing new chemical substances over
the past six years, OTS has developed a special expertise and
recognition in the application of structure-activity relationships
(SAR) to the evaluation of chemical hazards. During FY 1P86, OTS
assisted a number of other groups by providing high quality hazard
assessments of a variety of poorly studied chemicals. For example,
OTS assisted the Office of Pesticide Programs in evaluating the health
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and environmental effects of 37 pending pesticide inert inqredients.
OTS also assisted the Office of Solid Waste and Emergency Response
(OSWER) hy providinq SAR-hased analyses of potential carcinooenicity
and chronic toxicity of 515 chemicals on the Comprehensive Environmental
Response, Compensation and Liability Act fCFRCLA) "Reportahle
Quantity" list. During FY 1QS6, OTS also assisted several States
and EPA reqions as well as the U.S. Departments of State and
Defense by providina SAR-hased analysis of a variety of chpmicals
including environmental pollutants, chemical tracking agents,
research and development chemicals, etc.
OTS technical expertise supported the Office of Water Peculations
and Standards' Effluent Guideline on the Orqanic, Plastic and
Synthetic Fibers Industry-. The information that OTS proviripd or
developed included 1^50 data, hiocohcentration-, half-lifp in water,
cancer risk values, and otHpr faf.e and transport values.
OTS also, provided Region 7 with-a.ll the information needed
to evaluate its need for an information services unit.
STATE
PROGRAM
The exchange of information between States and EPA benefits both.
The States benefit by gaining access to chemical information that
can help them develop solutions to local toxics problems that may
not he addressed hy Federal authorities. EPA benefits hy receiving
information (e.g., data on release, exposure, pt.c.) from the
States which can help the Agency anticipate and plan solutions
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to emerging problems. A mutual benefit of information exchanae
is the use of similar rlata; this will hopefully lead fo
standardizing regulations developed at the .State and. Fedprai
levels.
To facilitate the exchanae of toxics information and
technical expprtise between State and Federal officials, a forum
was provided throuqh a grant with the National Governors'
Association (NGA), which sponsors conferences and workshops of
this nature. FY 1986 conference topics included: Chemical
Safety and. Emergency Preparedness; Indoor Air Pollution: Total
Exposure to Toxics; and a workshop entitled Designing a Risk
Assessment Office. In addition, the NfiA grant provides- an
information clearinghouse and ripvelnps "how-tri" memoranda, issue
briefs, and conference proceedings.
Additional meetings with Strate officia-ls' have~ taken
place with representatives of key States includinn California,
Michigan, North Carolina, Maryland, South Carolina, Virninia,
Kentucky, New Jersey, Minnesota, and Illinois. These meetinos
have had two main purposes: to determine common areas of concprn
in the toxics mananement area; and to promote the exchange of
risk information, health and safety data, the availability of
on-line data assistancp, and thp exchange of information regardina
ongoing studies of specific chemicals. The target audiences
for such briefings include staff of State environmental (natural
resources), public health and agricultural departments.
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MINET
In another effort to inform States of TSCA information and
activities, OTS has joined a telecommunication*; network, the
Medical Information Network (MINET) which has 43 State health
departments online. In FY 198fi, OTS sponsored 13 Statp
environmental departments to enable them to sinn on to the
system as well. MINET notifies States of key Federal Register
notices; of new assessments and health data; of the availability
of Chemical Hazard Information Profiles (CHTPs) documents; of
regulatory aqenda; and of conferences, meetings, and seminars.
Through MINET, States may request information on specific chemicals
that are related to their own State activities.
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7. COMPLIANCE AND ENFORCEMENT
EPA has developed specific strategies to enforce regulations under
TSCA. These strategies identify and rank possible violations,
identify the available tools for compliance monitoring, specify
how these tools are to be used, and provide a formula to determine
the applications of inspection resources. Where inspections uncover
violations of TSCA requirements, EPA levies civil penalties, as
authorized by section 16 of TSCA.
PROGRAM
ACTIONS
During FY 1986, EPA developed and issued compliance monitoring
strategies for the Asbestos Abatement. Projects Rule and.the PCB
Transformer Fires Rule. EPA also developed and issued an Amendment
to the Revised Asbestos-In-Schools Enforcement Response Policy,
and.Interim Final Amendments to the Enforcement Response Policy
for TSCA section 13 (imports) and TSCA section 8(a) (reporting
rules)..
EPA continued cooperative enforcement programs to monitor
compliance with the PCB regulations in the States of Connecticut,
Florida, Maryland, Michigan, New Hampshire, North Dakota, Ohio and
Texas; and cooperative enforcement agreements to monitor compliance
with Asbestos-In-Schools regulations in.the States of Arizona,
California, Colorado, Idaho, Iowa, Maryland, New Hampshire, Oklahoma,
Texas, West Virginia and Wisconsin. In FY 1986, the States conducted
732 PCB compliance inspections and 877 Asbestos-In-Schools compliance
inspections.
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COMPLIANCE
ACTIONS
The California and Idaho Ashestos-In-Schools cooperative enforce-
ment agreement programs were completed in FY 198*. For the .States
of California, Kansas, Puerto Rico and Washington, PCP cooperative
enforcement agreement programs were initiated late in FY 1986.
In FY 1986, EPA conducted a hroad range of insppctions for TSCA
reguirements. FY 1986 was the first year in which FPA conducted
asbestos worker protection inspections. Fifty-five of these
types of inspections were carried out. The FPA, alono with piqht
State agencies cooperatina under the terms of enforcement grant.s-
in-aid, conducted ?,371 PCP compliance monitorina inspections. In
addition, the Agency, operatinq under a cooperative agreement with
the American Association of Retired °ersons and fhp Statps of
Arizona, California, Colorado, Idaho, Iowa, Maryland, New Hampshire,
Oklahoma, Texas, West Virginia and Wisconsin, conducted 3,?7n
Ashestos-in-Schools inspections.
During FY 1986, the Agency also monitoring compliance with
TSCA section 4, 5, 8, and 13 reguirements. FPA inspected 1.6
laboratories conducting testing under TSCA to determine if the
laboratories were in compliance with Good Laboratory Practice
(GLP) reguirements. During these inspections FPA conducted 65
audits of health and environmental tests to determine if testing
had been conducted according to test protocols, and if reoorts
accurately reflected study findings. EPA also conducted over
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CIVIL
ENFORCEMENT
ACTIONS
inspections to determine compliance wifh section R and 8 require-
ments. The Agency conducted a total of 1,005 inspections to
determine compliance with section 13 chemical import requirements.
Again in FY 1986, the number of administrative complaints issued
by the Regions increased over those issued in FY 1Q85. A total of
781' administrative complaints were issued in FY 1Q86 compared to
733 in FY 1985. For allege^ failure to comply with the import
certification requirements (section 13), the Aaency issued ?3
civil administrative-complaint's.. The Aqency also issued-APS civil
administrative complaints for alleged violations of the section fi
asbestos-in-schools requirements and 3?3 administrative complaints
as* a result of PCR inspections... Tn addition, FPA--issued .? civil
complaints, for a-lleaed violations'of section s(a), and R civil
complaints' for alleged violations of section 5. Hqures for each
EPA Regional Office and Headquarters appear in Table 5.
The following are case summaries of sianificant TSP.A.civil
administrative and judicial cases concluded during FY 1Q86.
United States vs. Southeastern Pennsylvania Transit Authority
(Civil Action 86-1094 E.D. Pa) - Paoli, Pennsylvania. This TSCA
section 7 emergency action, filed jointly as part of CERCI.A and
RCRA action, is addressing the imminent hazard to health and the
environment posed by massive PC8 contamination at the Paoli
Railyard near Philadelphia. The Paoli Railyard serves as the
major northeast junction and repair terminal for commuter trains
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owned and operated by Septa, Amtralc and Conrail, the joint
defendants. The civil action souqht. the cleanup of all PCR
and PCB-related toxic substances at the Paoli Railyard and
the surrounding area. Extensive contamination of adjacent
residential areas is being addressed on an emergency basis by
an EPA-constructed surface runoff containment system, and by
related removal actions.
Union Carbide Corporation (Docket No. TSrA-flS-H-n?) - nanhury,
Connecticut. This administrative penally enforcement action
charged Union Carbide with the failure to provide to the Agency
substantial risk information, namely, a cancer study on diethyl
sulfate, as required by section 3(e) of TSCA. Following a ypar
of administrative litigation, the innovative settlement agreement,-
which i* oresently before the Judicial Officer for approval, requires
a comprehensive environmental audit of the comoany's risk information
and provides for a novel alternative dispute resolution (Anp)
procedure, the first such use of ADR in an FPA enforcement action.
BASF Systems Corporation fPocket No. TSCA-85-H-nd) - PedfnrH,
Massachusetts. In this action, BASF voluntarily disclosed that- it
imported and used chemical substances that had not been listed on
the TSCA Chemical Substances Inventory, which constitutes a violation
of the section 5 premanufacture notification requirements of TSCA.
In the settlement of the subsequent enforcement action, RASF aoreed
to pay a fine of $80,000 and to initiate a comprehensive environmental
compliance audit of its operations at- Bedford, Massachusetts. BASF
is required to report any violations discovered in the course of the
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audit to EPA within 15 days- of discovery, and pay a minimum
penalty of $10,000 for each chemical violation reported for
chemicals that do not represent a threat to health or the
environment. For other chemicals, E°A is free to seek the
maximum civil penalty. In addition to these terms, RASF
agreed to conduct an evaluation of the TSCA compliance program
of its parent corporation, PASF, A.R., of West Germany.
United States vs. Commonwealth Edison (Civil Action P4-C-1.507,
N.D. IL) - Chicaao, Illinois. Thp Consent Pecree in this
enforcement action, signed in FY 1986, resolves FPA charoes
that Commonwealth Edison was not properly decontaminating
spilled PCBs from pole-mounted electrical capacitors-, which
resulted in residual contamination as high as.^.fiOD - 33,-5nn pnm.
The company agreed to conduct soil samplina and analysis for thp
presence of PCBs at an pstimated' Son spill' sifes in Northern
Illinois, and will decontaminate to an FPA approved level an
additional estimated 3^0 spill sites. As part of this settlement,
Commonwealth Edison is also scheduled to remove all pole-mounted
capacitors by January 19*7.
DuPont Corporation (Pocket No. TSCA-8fi-H-01 ) _ Wilmington, Delaware.
In this action, DuPont was charged with violations of TSCA section
5 premanufacture notification requirements for new substances and
paid a ^100,000 civil penalty.
Under the terms of settlement, DuPont 's Finishes and
Fabricated Products Department, the Division involved in this action,
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is required to formalize a series of TSCA section 5 compliance
assurance procedures. These procedures were compiled into a
guidance manual for employees affected by TSCA requirements.
The manual has been distributed at plants and laboratories
throughout the country. Training programs, with respect to
the compliance procedures, have been held at many of DuPont's-
facilities.
The settlement required DuPont to produce a broadcast quality
videotape on the requirements of TSCA, to be used as part of the
company's employee education program on TSCA compliance. In addition,
DuPont is developing an "artificial input" system to monitor TSCA
compliance. .Under this program, test inputs will be designed to
test the company's ability to recognize and prevent the unlawful
manufacturing or importation of new. chemical- substances that are
not on the TSCA Inventory, and the release of new products containing
components that are not on the Inventory.' Results of these tests
will be reported to'EPA.
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Table 5 Administrative Civil Actions Taken under section 16 of TSCA, Complaints
Issued, Cases Completed, and Amounts Assessed (by Region)*
Region
1
2
3
4
5
6
7
3
9
10
HQ
TOTAL
Total No.
Complaints
Issued
FY' 79-86
110
350
193
184
'615
221
261
215
149
171
29
2,498
No.
Complaints
Issued
FY'86
31
110
61
34
162
63
76
85
64
89
6
781 1
Total No.
Cases
Completed
FY1 79-86
59
218
119
137
419
126
133
122'
92
53"
19
,497
No. Cases
Completed
In
FY'86**
18
62
25
23
105
22
13
43
40.
10
2
363 1
Total No.
of Cases
Pending
51
132
74
47
196
95
128
93
57
118
10
,001
Total Civil
Penalties
Collected
($) in FY'86
133,504
632,030
262,670
37,855
802", 490
191. ,.780
122,380
60,000
191,330
288,955
160,000
2,882,994
Total Penalties
(In $) Collectec
FY'79-86
483,735
2,405,815
803,805
429,527
5', 236, .879
1,536,245
511,035
461,515
692,455
438,095
1,954,750
14,953,856
* All actions taken involved alleged violations of TSCA sections 4,5,6,8, and/or 13.
** Includes cases carried over from FY 1980 - FY 1985.
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8. LITIGATION
ENVIRONMENTAL DEFENSE FUND, INC. v. ENVIRONMENTAL PROTECTION AGENCY
(No. 79-1580, D.C. Cir.)
In 1979, the Environmental Defense Fund (EOF) petitioned for review
of EPA's regulations under TSCA section 6(e)(2) and (3) governing
the manufacture, processing, distribution, and use of polychlori-
nated 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':; 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.
Litigation developments for FY 1986 are described below.
August 1982 electrical equipment rule. Previous TSCA Annual
Reports described the litigation and subsequent additional rules
resulting from the August 1982 rule. One of the additional rules,
issued in July 1985, placed additional restrictions and conditions
on the use of PCB transformers. The July 1985 rule generated
another lawsuit — MISSISSIPPI POUER COMPANY v. EPA (No- 85-4498,
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5th Cir.). No further action has been taken in this case in FY 1986
pending the outcome of settlement negotiations.
October 12, 1982, closed manufacturing processes rule. The
Chemical Manufacturers Association (CMA) filed a petition for review
of this rule in December 1982 — CMA v. EPA (No. 82-2518, D.C. Cir.).
This suit was rendered moot as a result of developments in the suit.
on the July 1984 rule, discussed below. In August 1986, the Court
approved a joint motion to dismiss.
July 1984, inadvertent generation rule. In late September 1984,
petitions, for-review of the July. 1984 rule were filed by the-American
Die Casting Institute and Outboard Marine Corporation in the Seventh
Circuit, and by the American Paper Institute and Fort Howard Paper
Company in the D.C. Circuit., The Seventh Circuit petition was
transferred to the D.C., Circutt where the Court consolidated all
cases — AMERICAN PAPER INSTITUTE v. EPA (No. 84-1481, D.C. Cir.)
and CONSOLIDATED CASES. The Chemical Manufacturers Association was
granted permission to intervene.
A Settlement Agreement was filed with the Court in August 1986
by most of the parties. Fort Howard Paper Company opposed the
Agreement. EPA has agreed to propose and obtain public comment on
amendments to the rule that may allow certain activities involving
existing stocks of very low level PCB products and materials. EPA
also agreed to make a final decision on the proposal within specified
time frames. The other settling parties agreed to dismiss the case
if EPA issues a final rule substantially similar to the proposed
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amendments. The Court is asked to hold the proceeding in abeyance
until the rulemaking is completed.
Fort Howard Paper Company requested the Court not to wait for
the outcome of the rulemaking but to order EPA to issue a water
discharge effluent standard under TSCA for companies recycling paper
contaminated with low levels of PCBs. EPA argues that Fort Howard
will have the opportunity to raise its issues in the rulemaking
proceeding and that the Court should not waste judicial resources by
dealing with the issue before EPA has had the opportunity to consider
Fort Howard's position. The parties are awaiting the Court's final
decision on approval of the Settlement Agreement.
N.Q.C... Inc., t/a Noble Oil Company v. Administrator, (No. 85-3175
3rd Cir.) and (No. 85-1650, U.S. Supreme Court)
The Circuit Court of Appeals j'ssued'an opinion affirming EPA's
assessment against Noble Oil Company of a civil penalty of $40,000"
for three separate violations of Agency regulations on disposal,
marking and storage of PCBs. Arguments raised by Noble Oil were
discussed in last year's Annual Report. Thereupon, Noble Oil sought
review in the U.S. Supreme Court, arguing among other things that
(1) the PCB regulations were unenforceable because they were
invalidated by the D.C. Circuit in 1979 (see ab-ove) and (2) the
Administrator's decision was not supported by substantial evidence.
The Supreme Court denied review on June 23, 1986.
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 (1)
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Federal regulations setting standards for determining when an
asbestos hazard requiring correction exists in schools and other
public and commercial buildings, (2) requirements for abatement
activities where such hazards exist, and (3) 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.
On November 30, 1984, EPA issued a final decision with respect
to certain parts of SEIlTs 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.
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Activities in this area 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 was held in October 1985. In September 1986,
the Court issued an order indicating it intended to hold a new
proceeding on SEIU's request. As of the end of FY 1986, the Court
had not yet issued an opinion stating its reasons or an order
governing further proceedings.
Environmental Defense Fund (EOF) and National Wildlife Federation
(NWF) v. Thomas, (No. 35-0973, D.D.C.) '':'
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.
In early 1986, plaintiffs filed a motion requesting the Court to
order EPA to initiate rulemaking because the Agency had improperly
denied their petition. EPA opposed plaintiffs' request arguing that
its denial was in accordance with statutory requirements. The
parties are awaiting the Court's decision.
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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 (confidential business
information) under both section 14 of TSCA and EPA's confidentiality
regulations in 40 CFR Part 2. Polaroid challenged EPA's 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
.No. 78-1133S, 0. 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's entering a
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Consent Order. The Consent Order addressed two areas. First, EPA
was in the process, 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, in the
course of settlement discussions, EPA and Polaroid identified
certain additional refinements which EPA concluded would be
worthwhile. The Consent Order committed EPA to making those
additional refinements and to reporting to the Court when they
were completed.
The Court dismissed the case on September 4, 1986, after the
last of the requirements of the Consent Order were met.
Chemical Manufacturers Association v. Environmental. Protection
Agency (No. 84-1569, D.C. Cir.)
On November 19, 1984, the Chemical Manufacturers Association (CMA)
filed a petition for review of the first significant new use rule
EPA promulgated under section 5(a)(2) of TSCA. The rule 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
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defer briefing until EPA proposed revisions to these procedural
provisions. The revisions were proposed on April 22, 1986.
CMA and EPA entered into a settlement agreement under which CMA
will voluntarily dismiss its action if EPA promulgates revisions
substantially similar to those proposed. Further action in this
case is stayed pending completion of the rulemaking.
Citizens for a Better Environment, et al. v. Lee M. Thomas
(No. 85 C 08000, N. 111.)
In September 1985, two public interest, groups challenged EPA's
decision denying their petition filed in April 1985, pursuant to
section 21 of TSCA. The petition had requested EPA to identify
business entities in the southeast area of Chicago which were
releasing 1.1. named chemical substances into the environment, and. to
initiate rulemaking under TSCA section 4(a) to require testing on
the chemical substances — including.testing for cumulative and
antagonistic effects. EPA denied the petition, in part, on the
basis that there are no available test standards for studying
cumulative effects of chemical substances. In addition, the
denial notice indicated that health effects data were adequate for
regulatory assessment. Finally, the notice stated that EPA had
already identified 44 businesses in-southeast Chicago which emit
pollutants into the air, and that EPA was conducting a variety of
environmental investigations in southeast Chicago.
The discovery process, wherein each side may request documents
and depositions from the other side, has been initiated and may
continue until the spring of 1987.
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Shell Chemical Co. v. EPA (No. 86-4161, 5th Cir.) and Shell
Chemical Co. v. Thomas (No. 86-2671, D.D.C.).
On January 7, 1986, four manufacturers of mesityl oxide and the
Chemical Manufacturers Association filed in the Court of Appeals a
petition for judicial review of EPA's final rule requiring health
effects testing of mesityl oxide (Shell v. EPA). The rule was
published in the December 30, 1985 Federal Register (50 FR 51857).
The proceeding was held in abeyance pending EPA's consideration of
the manufacturers' petition under section 21 of TSCA to withdraw the
test rule. EPA denied the petition on August 21, 1986 (51 FR
30216). The manufacturers have informed the Court that they will
reinstitute the lawsuit.
The four manufacturers have also filed an action in District
Court, on September 26, 1986, challenging the denial of their section
21 petition (Shell v. Thomas). Th-is District Court action may be
stayed pending the outcome of the reinstituted lawsuit in the Court
of Appeals.
Jack Pierce, d/b/a Jack Pierce Waste-Oil. Inc. v. EPA (No. 86-1486,
7th Cir.):
Jack Pierce seeks review of a $29,000 penalty assessed by EPA for
violation of the Agency's PCB disposal regulations. Pierce challenges
EPA's determination that he owned the tanks from which PCBs spilled
and the legal conclusion that he could be held personally liable for
a violation alleged to be caused by his business. The case is being
held in abeyance pending the outcome of settlement negotiations.
New Orleans Public Service. Inc. v. EPA (No. 86-4577, 5th Cir.)
New Orleans Public Service, Inc. seeks review of a penalty assessed
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by EPA for improper disposal of PCB-contaminated transformers.
The administrative record of the penalty proceeding before EPA has
been filed with the court. Briefs containing legal arguments are
expected to be filed shortly.
U.S. v. Cannelton Industries, Inc. (No. 83-2406, S.D.W.Va) and
CONSOLIDATED CASES.
This group of three cases resulted from a spill of PCBs from a
transformer in an underground mine operated by Cannelton. EPA
filed a complaint alleging Cannelton violated the Agency's regulations
regarding disposal of PCBs. Cannelton filed two suits against EPA.
One suit requested that the court declare Cannelton's rights and
resppnsibilites with respect to storage and disposal of PCBs in its
mine. In the second sui.t, Cannelton requested- the Court to order
EPA to .initiate a'proceeding .to amend .its PCB disposal rules. EPA
and Cannelton reached an agreement on cleanup of the. PCBs, which
was approved by the Court in February 1986. The court has retained
supervisory jurisdiction over the agreement.
Two suits were filed against EPA regarding the Agency's
consideration of whether to allow a PCB disposal facility in
Henderson, Kentucky.
Michael D. Vanderveer and City of Evansville, Indiana v. EPA and
Unison Transformer Services. Inc. (No. EV86-183C, D.C.Ind.)
Plaintiffs requested a preliminary injunction to prevent a trial
demonstration, approved by EPA, of Unison's PCB disposal process.
The process chemically separates PCBs from transformer fluid. The
PCBs are then shipped to other facilities where permanent disposal
takes place.
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In support of the preliminary injunction plaintiffs argued that
the City of Henderson, Kentucky had failed to comply with.its
procedures for issuing zoning permits before the trial demonstration
was authorized. The Court denied the preliminary injunction on
September 11, 1986, stating that the citizens did have an adequate
opportunity to present their views before the zoning authority.
Plaintiffs also requested a permanent injunction against
operation of the facility, stating in their complaint that EPA needs
to consider criteria applicable under the Resource Conservation and
Recovery Act (RCRA) in addition to criteria under TSCA when approving
the Unison facility and that the operation of the facility would
present an unreasonable risk of harm to plaintiffs. Further
proceedings on the permanent injunction are expected during FY
1987.
Citizens for Healthy Progress, Inc. v. EPA (No. 86-0155, D.C.
Kentucky]
Plaintiffs in this suit, filed on September 18, 1986, are requesting
temporary and permanent injunctions to prevent EPA from allowing
operation of the Unison facility. The Complaint states that the
permit for the facility should only be granted after consideration
of RCRA criteria, not criteria under TSCA, and that they are unable
to evaluate the risks caused by the facility because EPA and Unison
have not disclosed the identity of the chemical used to separate
PCBs. Further proceedings are expected in this case in FY 1987.
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9. INTERNATIONAL ACTIVITIES
Since" the passage of TSCA, EPA has been involved in a number of
international activities to promote coordinated approaches to
evaluating and managing toxic substances. The Agency considers
these programs of critical importance, and continued to play a
very active role during FY 1986. EPA's i-nternational activities
include the exchange of information and expertise, which provides
significant benefits to several international organizations.
One of its most visible and successful international efforts
is its participation in the Chemicals Group and Management Committee.
of the Organization for Economic Cooperation and Development
(OECD). The OECD, a 24-member international organization comprised
of the world's major industrialized nations, was founded both
to. promote the development of, and. to 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. It therefore established a program
in 1977 to develop harmonized approaches to the review, evaluation
and management of toxic substances.
During FY 1986,. EPA continued to build on several important
initiatives and, through continuing preparations for a third
meeting of the Chemicals Group at High Level (HLM III), to define
a framework for Chemicals Group and Management Committee activities
into the next decade.
Three early efforts in the Chemicals Program involved hazard
assessment, good laboratory practice and confidentiality of data;
important followup work was also initiated in 1985. During 1986,
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significant progress was made in each of these important areas.
Responding to previous recommendations of hazard assessment experts
that the initial work in this complex area should focus on exposure
assessment, a Workshop on Practical Approaches to the Assessment
of Environmental Exposure convened in Vienna, Austria, in April
1986. The Workshop produced reports summarizing the technical
methodologies Member countries use for conducting environmental
exposure assessments in three areas Source Characterization, Fate
and Pathways, and Targets of Exposure. U.S. experts were generally
pleased with the outcome. Further work on hazard assessment will
be developed and undertaken under the supervision of the newly
established Hazard Assessment Panel, which the U.S. chairs..
With regard to Good Laboratory Practice, GLP experts met twice
during 1986 and. reached agreement on two basic'documents: the Guide
for Compliance Monitoring Procedures for Good Laboratory Practice
and Guidance for the Conduct of Inspection and Study Audits.
Although the group agreed that it had completed its major tasks
and should not continue after May 1987, it also recognized that
GLP experts should continue to meet periodically to exchange
information and experiences in GLP implementation.
An expert group on confidentiality met twice during 1986 to
continue efforts to develop a model form for agreements for the
exchange of confidential information. After initial difficulties,
this group has succeeded in producing a model form for bilateral
agreements, as well as guidance for countries negotiating such
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agreements that is designed to highlight important issues for
consideration during negotiations.
In the area of existing chemicals, the pilot phase of the
Chemical Information Switchboard, which began with six countries
(including the U.S.) during 1985, continued operations during 1986
to increase Member state access to unpublished information on
chemicals. Early in the year, agreement was reached with other
pilot members to increase the number of allowable requests from
two to four per month, since the Switchboard seemed able to
accommodate such an information exchange. An evaluation of the
usefulness of the Switchboard will be initiated late in 1986 and a
determination made concerning the expansion of the. Pilot to all
OECD Member states.
Increasingly, EPA's attention and efforts have focused on
preparations for the third meeting of the Chemicals Group at High
Level (called HIM). 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. A special Steering
Group to prepare for HIM III met three times in 1986 to discuss
HIM documents on: past Chemicals Program achievements, Chemicals
Safety Testing and the Use of Animals, Cooperation on Existing
Chemicals Investigation, Chemicals Risk Management, and the Future
of the Chemicals Program.
The Ongoing Chemicals Program activities that are important
to OTS are the Test Guidelines Updating Panel and the Complementary
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Information Exchange Procedure. During the past year, four new
guidelines in genetic toxicology were adopted by the OECD Council.
The Updating Panel endorsed revisions to three acute toxicity
guidelines, primarily as a result of ongoing a.nd increasing
concern for animal welfare. This concern was apparent
at two meetings during 1986, an experts meeting in April on acute
toxicity testing, and a Seminar on Chemicals Testing hosted by the
government of Sweden in May.
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 used to- an increasing degree..
EPA also participates in several programs of the United Nations,
such as the United Nations Environmental Program (UNEP) International
Register of Potentially Toxic Chemicals (IRPTC) and the World Health
Organization (WHO) International Program on Chemical Safety (IPCS).
The basic objective of the IRPTC is to promote 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 1986, the IRPTC
assumed responsibility for compiling regulatory information on
chemicals slated for inclusion on the U.N.'s Consolidated List of
Banned, Withdrawn or Severely Restricted Products.
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A UNEP group of experts continued work during 1986 on the
development of guidelines for the exchange of information related
to banned .or severely restricted chemicals in international trade.
An information exchange scheme on such chemicals, which closely
resembles EPA's existing export notification procedures has been
in operation on a provisional basis since 1984. The experts will
meet to finalize the guidelines in February 1987.
The IPCS was established in response to the 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., OTS has been the-1 lead-
in preparing'the IPCS assessment document on gly.c"ol ethers and-
also will be preparing such documents for nitrobenzene, 2-nitro-
propane, chloroparaffins and methyl ethyl ketone. In response to .
the Bhopal tragedy, IPCS launched an effort to promote
international chemical safety. The first steps of this effort
include projects on reactive intermediates, and the identification
of national emergency response mechanisms and reported incidents.
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10. RESEARCH AND DEVELOPMENT ACTIVITIES
Toxic substances research provides support to meet the current and
future needs of the Toxic Substances Control Act. Research
efforts are geared toward providing scientifically valid yet cost-
effective evaluations of the risks associated with the manufacture
and use of new and existing chemicals.
The research program in support of TSCA develops, evaluates,
and validates health and environmental test methodologies and
procedures to improve the predictability of human risk estimates
and to develop exposure monitoring systems, environmental fate and
effects methods, and develops guidelines to perform environmental
risk assessments. Additional research develops and evaluates
release and control methods for new and existing chemicals, structure-
activity relationships as predictors of chemical fate and/biological
effects, and procedures for ensuring the human and environmental
safety of the products of biotechnology.
MAJOR
RESEARCH
ISSUES
Test Method Development
Under TSCA, manufacturers must test chemicals for potential
hazards to human health and the environment. Consequently,
research is conducted to provide guidance for performing such
tests,. Regulatory decisions on a chemical depend on qualitative
and quantitative scientific data from industry regarding the
potential adverse environmental and human health effects of
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exposure to the chemical. Sensitive, reliable, cost- and time-
effective tests are needed; therefore, the Agency is developing
and approving carefully screened methods. Such methods will he
incorporated into testing guidelines for use by industry and
others who must evaluate the safety of chemicals.
Structure Activity .Relationships (SAR)
To enhance the efficiency of the regulatory process for toxic
chemicals, EPA groups various chemicals which share common or
similar chemical characteristics instead of dealing separately
with each individual chemical. If it can he demonstrated
that chemical relationships, such as similar molecular structures
and simiTar modes of toxic activity, form a-firm scientific basis
for estimating probable environmental risks, then better guide-
lines and techniques can be applied and regulatory actions can he
completed more quickly using less resources. The SAR approach
is vital for reviewing and screening new chemical substances
under section 5 of TSCA. The findings and techniques established
in this research are used to select appropriate toxicity tests, to
document test results, to develop fate and effects data bases
where necessary and to provide the modeling means to predict
toxicity.
Special Human Data Needs
To improve the Agency's ability to estimate human risk, these
activities examine population groups exposed to environmental
contaminants which are suspect toxicants to determine if biological
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indicators of Hose and/or effects are related to environmental
levels of exposure. Data are also being developed on adverse
effects as measured hy traditional eoidemiological studies.
Ecology: Transport/Fate/Field Validation
To adequately evaluate the likely perturbations a toxic
chemical may cause in the environment, it is necesary to
understand probable exposure concentrations and durations,
movements through ecosystems, degradation rates, reservoirs,
effects and residues. The Agency must have available techniques
which may be applied to attain this information, must be caoable
/
of interpreting findings and must have a predictive capacity ^o
anticipate problems. Activities in this area are desinnpd to mpet
t.hpse needs, to improve the criteria and standards with which
industry, the user?;, nr the Agency must comply. Thp int.pnt is to
provide new or improved state-of-the-art technigues to fill data
gaps in order to take regulatory actions that are both scientifically
credible, and legally defensible.
Health: Markers, Dosimetry, and Extrapolation
Health effects research, is focused on development of methodol-
ogies for the extrapolation of data from high to low doses and
between mammalian species, to enhance human health risk assessment
predictability. Additional studies in the toxic substances research
program involve defining the relationship between biologic markers
of exposure and non-cancer health endpoints such as neurotoxicity
and immunotoxicity as well as genotoxic endpoints. Posimetry
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studies are examining dermal and inhalation routes of exposure.
Extrapolation research has a larae pffort dpvoted to gpnpt.ically
mediated health effects.
Exposure Monitoring
The major TSCA-related monitoring research efforts are
currently directed toward improving the monitoring systems
designed to estimate total human exposure. Research is also
.continuing on approaches for multi-media/multi-pathway monitoring
systems which generate-data that will provide an estimate of total
human exposure. Epa is also conducting studips to incorporatp
environmental dose into personal exposure monitors to provide a
better understanding of the contribution-of diffprent pxposure
•
routes to pollutant intake. The relationship of network monitoring
to personal exposure monitoring will be eyalua-ted in-a Human
Exposure'Assessment- Location Proipct.,
Biotechnology/Microhial and Biochpmical Ppst Control Agents
Users of hiotechnological products must follow recommendpd
Agency guidelines in a Besting regime designed to help prevent.
adverse environmental impacts. EPA's Office of Research and
Development (ORn) helps establish these technigues, determines if
environmental effects are exhibited by previously untested non-
target organisms, and conducts field-oriented validation studies
as necessary to ensure that testing criteria and guidelines are
appropriate and functional. Engineering research is also underway
•
to develop and/or improve methods to contain or destroy genetically
engineered organisms.
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Under TSCA, efforts focus on developing scientific rationales
and procedures for evaluating the environmental survivability,
reproduction, distribution, effects and risk associated with
the escape of genetically manipulated organisms. The results will
be used to prepare protocols for use in evaluating TSCA products
involving environmental application of microbes. This research
wi.ll also support regulatory rulemaking by specifying which products
are to be considered under TSCA.
In the health research area, studies are being conducted to
determine the genetic stability and function of a baculovirus
expression vector in vertebrate cells. Methods are also being
developed to evaluate the potential health consequences of
deliberate or inadvertent release of genetically altered organisms.
Engineering Release and Controls
Under section 5, manufacturers are required to submit information
to EPA on both the release and control of new chemical substances,
and on significant new uses of designated existing substances.
EPA uses existing data to predict the risk.s from the release of
new substances, and under the existing chemicals control program,
evaluates technological alternatives to reduce the release of and
exposure to chemicals that are already in use.
Models are being developed which predict release of and
exposure to classes of new substances, in order to assess chemical -
unit operations and processes, and the physical and chemical
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properties of chemical substances. Models to predict potential
exposure and release levels, as well as the best control measures
to control release of and exposure to new substances are also
being developed. Treatability testing of potentially toxic
chemical.s is also being conducted.
Alternatives devised to mitigate the release of and exposure
to specific existing and pew toxic substances are being defined,
through the evaluation and adaptation of control measures related
to the release of chemicals in the workplace and into the environ-
ment. EPA is also evaluating technologies, management, practices,
and personal protective equipment.to limit exposure to those toxic
substances and their release into the environment.
Ecology: .Ecotoxicity and Risk Assessment.
In the. past, the emphasis of ORD's scientific assessment
program has been on the assessment of risk to human populations.
However, there is also a need to assess the risk to non-human
populations and to the environment. The development of ecological
risk assessment methodologies for terrestrial and aquatic ecosystems
(primarily endangered species and commercial fisheries) is necessary
to quantify the probability that adverse effects may occur as a
result of exposure to a toxic substance, and to estimate the
significance of such effects in the environment. .Since environmental
data developed by industry may vary greatly from chemical to
chemical, procedures need to be developed which provide guidance
and consistency for the various environmental exposure activities.
This work will provide risk assessment protocols, guidelines, and a
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computerized decision support system for the assessment of effects
to terrestrial and aquatic ecosystems. This decision support system
will provide analysts in OTS with information on specific ecological
risks and their long-term consequences to provide the technical
foundation for regulations based on probable ecological damage.
Support
For certain assessments, the technical expertise of the ORD
staff is required to conduct literature searches, interpret data
or render technical and scientific judgments due to of the lack
of data. In cases where program office evaluations are complicated
and/or controversial, independent peer review of assessments is
required to ensure consistency. There is a continuing need for
ORD participation in and review of major.exposure and hazard
assessments conducted by OPTS, for supplying Agency policy-makers
with technical assistance from qualified scientists, and for
improving the scientific basis of Agency decisions in regulatory
matters. Finally, in both the pesticides and toxics areas, support
will continue for quality assurance, and the maintenance and
dissemination of standard reference materials.
See Appendix H for a summary of FY 1986 accomplishments.
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Appendix A
Summary/Guide to Information Required hy Congress
Sections 30, ?R(c) and 9(d) of TSCA require that, certain information he
reported each year to the President and Connress. 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 qiven
here:
Section 3D, This section contains the basic requirement for the Annual
Report as follows:
(1) Testing. Tn FY 19fl*, EPA published 17 notices of proposed rulemaking,
10 proposed t»st standards, 9 notices of final rulemaMnq, and 6 decisions
not to test (see-Tahlp-4).,.
(?) New Chemical Substance Submissions. EPA received ?,?13 new chemical
substance notices f"l,fi93 Premanufacture Noticps, Fifi Test Market Exemption
Applications, 233 Po'lymer Fxemption Nnticesv and ?31 Low >'.o1ume Exemption
Notices]' during EY 1Q86, which brought the "trot a T received since .thp.
proaram's heginninq in mid-1979, to-3,511. None-of these substances
were subject to rulemaking under section 4. In EY 19Pfi, 3? cases
underwent voluntary testing or control activities, while P7 chemicals
were subject to the development of either a section fife) or 5(fl order
(see Table 1).
(3) Rules Issued under Section 6. During FY 19«fi, four rules were
published under section 6. One action responded to ?? PCR exemption
petitions (NFR); the other three actions were related to asbestos
activities (1 ANPR, 1 NPR, 1 NFR) (see Chapter 4, Existinn Chemicals
for detailed description of PCB and Asbestos accomplishments).
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(4). Judicial Actions under T.SCA and Administrative Actions under Section 16.
Judicial actions involved PCRs, asbestos, dioxins, significant npw use
rules, FPA's testing program under section 4 of TSCA, and section ?1
citizen petitions.
Ry far, the greatest amount of litigation was on PCRs. There has hpen
extensive litigation on PCR rulemaking resultina from the 1QPO decision
invalidating FPA's original PCR' rules. All thp lit.ination involving rule-
making suhseguent to the 19PO decision, however, is likely tn he settled.
Four PCR cases involved situations .where FPA was enforcing its PCP disposal
regulations. Three PCR enforcement related cases were appeals from penalties
assessed hy FPA; one was resolved in FPA's favor, two have heen recently
filed and are awaiting the setting of a schedule for submitting hripfs.
One PCR enforcement-related case (actually a'consolidation of three cases
involving the same company) was settled when the defendant and FPA anreed
to procedures for cleanup of PCRs. -Two lawsuits have been filed recently
against FPA's approval of a PCR disposal facility in Henderson, Kentucky.
Three suits are pending attempting to compel FPA to regulate, one with
respect to dioxins, one with respect to asbestos, and one to require tpsting
of certain chemical substances present in the southpast area of Chicaqo.
A petition for rev'iew was filed with respect to the first sianificant
new use rule under section 5(a)(?); briefing has been stayed pendinq further
rulemaking.
A petition for review has been filed challenging one of FPA's rules to
require testing under section *(a) Of TSCA.
(5) Ma.jor Problems in Administering the Act. No major problems were
encountered in FY 19flfi in administering TSCA.
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(6) Recommended Legislation. Mo leqislative changes are souqht at this
time.
Section 2fl(c). This section reouires a report on grants to States durino
the year. There were no grants administered under TSCA in FY 1QPK.
Grants associated with asbestos were administered under the authority of
the Asbestos School Hazard Abatement Act (ASHAA) (see Chapter A on Fxistinq
Chemicals).
Section 9fd).. This section requires that FPA's efforts to coordinate its
TSCA activities with related activities of othpr Federal anenries he
reported annually.
During FY 19Pfi, EPA continued, in several formal and informal agree-
ments with- other Federal government proqrams, to address specific chemical
activities with respect to. the devplopment and implementation of regulations
under TSCA. One of these continued efforts1 is participation in the Federal
Asbestos Task Force, of which OSHA, CPSC and FPA are charter mpmbers.
Other members include the Food and Drug Administration (FDA), the National
Institute of Occupational Safety and Health (NIOSH), the National Institute
of Environmental Health Sciences (NIEHS), and the National Cancer Institute
(NCI). In FY 1986, the Plan for the Interaqency Pequlatory Investigation
of Chlorinated Solvents in four ma.ior exposure cateqories was submitted to
the EPA Assistant Administrators and senior manaoement of OSHA, CPSC, and
FDA. Representatives of the four agencies met in July 19flfi and essentially
approved the Plan. The Plan calls for submission of options to control
risks associated with metal cleaning and dry cleaninq in December 19P6, and
paint, strippers and aerosols in August 1937.
Five chemicals were referred to OSHA for regulatory consideration in
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FY 1986. These were: 1,3-butadiene; formaldehyde (apparel manufacturing);
glycol ethers; methylene bis (2-chlorobenzenamine) (MBOCA); and toluenediamines.
Under an interagency agreement with NIOSH, EPA and NIOSH completed selection
of a respiratory strategy for use in PMN review, and developed a final table of
assigned respiratory factors. Laboratory work on respiratory protection is
nearly complete; NIOSH will begin field studies in FY 1987.
In FY 198(5, the article, "Relation of Survival to other Endpoints in
Chronic Toxicity Tests with Fish" was published in Environmental Toxicology
and Chemistry. This was the result of work accomplished between EPA and
the U.S. Fish- and Wildlife Service (FWS). Also under the interagency
agreement with FWS, a wildlife toxicity handbook was reprinted.
The Agency continued to participate in FY 1986 on the Working Group
on Biotechnology, established by the Cabinet Council on National Resources
and the Environment. The group discusses major Federal interagency issues
on biotechnology and develops a coordinated position on them. Members
include: Biotechnology Science Coordinating Committee, the Department of
Agriculture, EPA, FDA, NSF and OSHA. A joint policy statement was published
in June 1986. Under an interagency agreement, the Department of Health
and Human Services/National Institute of Dental Research continued to
provide data and information management support for hazard and risk analysis
of genetically modified organisms.
Through an interagency agreement, the Agency is working with NIOSH to
better characterize occupational exposure and environmental release for
acrylates/methacrylates used in radiation-cured applications. NIOSH is
presently conducting walk-through industrial hygiene surveys to collect
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data from approximately a dozen facilities that process and use acrylates
in radiation-cured coatings, inks, and adhesives. The surveys, along with
NIOSH site reports,.are expected to be completed by March 1987.
Chemical Advisories are coordinated with other Federal agencies as
appropriate. For example,'advanced drafts of the Advisories on 2,4-Toluene-
diamines and burning used oil were reviewed by program management and
technical experts at OSHA, because of the obvious workplace setting of the
hazards covered in these documents.
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Appendix B
Major FY 1986 TSCA Actions
Description
Section
of Law
Date
4 Procedures Governing Testing Consent Agreements 06/30/86
and Test Rules under the Toxic Substances Control
Act
4(a) For listing of testing decisions see Table 4.
4(b) Test Guidelines Published 01/06/86
-Indirect Photolysis Screening Test
4(f) Methylene Chloride; Initiation of Regulatory 10/17/85
Investigation (Advance Notice of Proposed
Rulemaking)
5(a)(2) N,N,N'N'-Tetrakis(oxiranylmethy1)-l,3-cyclo- 01/13/86
hexane dimethanamine (Proposed Significant New
Use Rule)
Methyl ammonium- n-methyldithiocarbamate (Proposed "03/24/86
Significant New Use Rule)
Substituted benzenes, halogenated (Proposed 03/18/86
Significant New Use Rule) (2 chemicals)
Certain acrylate chemicals (Proposed Significant 04/04/86
New Use Rule) (4 chemicals)
Benzoic acid, 3,3'-methylenebis [6-amino-, di-2- 05/06/86
propenyl ester (Final Significant New Use Rule)
Certain alkylsulfonic acids ammonium salts 06/11/86
(Proposed Significant New Use Rule) (2 chemicals)
Poly(2-hydroxypropyl)melamine, polymers with 06/25/86
5-isocyanato-l-(isocyanatomethyl)-1,3,3-trimethyl
cyclohexane, 2-hydroxyethyl acrylate-blocked
(Proposed Significant New Use Rule)
Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl- 07/24/86
4-(trifluoromethyl) (Proposed Significant New
Use Rule)
109
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5(e)
1-Propanol, 3-mercapto-(Proposed Significant . 09/12/86
New Use Rule)
Hexachloronorbornadiene (Final Significant New 11/19/85
Use Rule on an Existing Chemical)
Hexamethylphosphoramide and Urethane (Final 03/19/86
Significant New Use Rule on an Existing
Chemical) (2 chemicals)
Pentach.loroethane (Proposed Significant New Use 03/24/86
Rule on an Existing Chemical)
Methyl ^-butyl ketone (Proposed Significant New 07/07/86
Use Rule on an Existing Chemical)
PBBs and Tris (Proposed Significant New Use 07/07/86
Rule on an Existing Chemical) (9 chemicals)
11-Aminoundecanoic acid (Proposed Significant 07/22/86
New Use Rule on an Existing Chemical)
Pentachloroethane (Final Significant New Use 09/09/86
Rule on an Existing Chemical)
Significant New Use Rules; Proposed Amendments 04/22/86-
to General Provisions and Individual Rules
(Proposed Rule)
Consent Order with Testing Trigger; Substituted 11/20/85
phosphate ester (P85-730) - requires protective
equipment to control worker exposure, and
ecotoxicity testing. The Consent Order includes
a testing trigger for a 90-day subchronic study.
Consent Order; Alcohols, Cl-4, ethers with 12/20/85
polyethylene-polypropylene glycol mono(2-
aminopropyl)ether, polymer with maleic anhydride
and trimethylolpropane triacrylate .(P85-1176) -
requires gloves, goggles and protective equipment
to control worker exposure pending development
of information.
Consent Order; Substituted aromatic amide (P84- 12/23/85
1136) - requires use of worker protective equipment,
including impervious gloves, safety goggles and
protective clothing. Training including warning
statements are also required, and MSDS.
110
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Consent Order with Testing Trigger; Substituted 12/24/85
aromatic (P84-954) - requires protective
equipment to control worker exposure, eco-
taxicity testing, and release monitoring. Consent
Order includes a testing trigger at which
tne Company must submit acute and chronic eco-
toxicity data.
Consent Order; Isopropylidene-bis-(l,l-dimethyl- . 12/24/85
propyl) derivative (P85-648) - requires
protective equipment and labeling to control
worker exposure pending development of infor-
mation.
Consent Order; Polymer of: methacrylate -acid; 01/03/86
succinic anhydride; phenol, 4,4'-(l-methylethyli-
dene)bis-polymer with (chloromethyl); 2-methyl-
irnidazole (P85-1014) - requires protective
equipment to control worker exposure pending
development of information.
Consent Order; Silicone ester polyacrylate 01/09/86
(P85-296) - requires protective equipment to
control worker exposure pending development of
information.
Consent Order; Ami no aery late monomer (P85-298) - 01/09/86
requires protective equipment to control worker
exposure pending development of information.
Consent Order; Substituted pyridine (P85-36) - 01/17/86
requires protective equipment and engineering
measures to control worker exposure pending
development of information.
Consent Order; Haloalkyl substituted cyclic ether 01/17/86
(P85-367/368) - requires protective equipment to
control worker exposure pending development of
information.
Consent Order; Haloalkyl substituted cyclic ether 01/17/86
(P85-369) - requires protective equipment and
respirators to control worker exposure pending
development of information.
Consent Order; Substituted pyridine (P85-706) - 01/17/86
requires protective equipment to control worker
exposure pending development of information.
Consent Order; Functionally modified urethane
(P85-1063) - requires protective equipment to 01/17/86
control worker exposure pending development
of information.
Ill
-------
Consent Order; Polyester polyurethane 01/17/86
(P85-1068) - requires protective equipment to
control worker exposure pending development
of information.
Consent Order with Testing Trigger; Disubstituted 01/24/86
alkyltriazine (P85-932/933) - requires protective
equipment and respirators to control worker
exposure. The Consent Order includes a testing
trigger for a 28-day oral subchronic study.
Consent Order; Cycloaliphatic epoxide 01/30/86
(P84-1137) - requires protective equipment to
control worker exposure pending development of
information.
Consent Order; 1,1-Oimethylpropyl peroxyester 01/31/86
(P85-680) - requires protective equipment to
control worker exposure pending development
of information.
Consent Order with Testing Trigger; Polypropylene 02/10/86
glycol alkyl ether (P85-390/891/892) - requires
protective clothing to control worker exposure.
The Consent Order includes a testing trig-ger for
a .90-day subchronic study..
Consent Order; Kel acrylate complex (P85-1XJ34) - 02./13/86
requires gloves to control worker exposure-
pending development of information.
Consent Order with Testing Trigger; Disubstituted 03/05/86
sulfide (P85-234) - requires a production volume
trigger, at which the Company must submit
28-day subchronic and sister chromatid exchange
studies.
Consent Order; Ester-modified epoxy resin 03/06/86
(P85-1380) - requires protective clothing to
control worker exposure pending development of
information.
Consent Order; Halogenated alkene (P85-1167) - 03/07/86
requires protective equipment and respirators
to control worker exposure pending develop-
ment of information.
112
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Consent Order with Testing Trigger; Polymer of 03/17/86
an aerylate ester and mixed methacrylate esters
(P85-1283) - requires protective equipment to
control worker exposure. The Consent Order
includes a testing trigger for a 90-day oral
subchronic study.
Consent Order; Omega-functional esterified hydroxy 03/17/86
methacrylate (P85-1302) - requires protective equip-
ment to control worker exposure pending development
of information.
Consent Order; Functional polyurethane from poly- 03/17/86
alkylene oxide, aliphatic diisocyanate and
substituted alkanol (P85-1318) - requires protective
equipment to control worker exposure pending
development of information.
Consent Order; Substituted amino anthraquinones 03/20/86
(P85-18) - requires protective equipment to control
worker "exposure pending development of information.
Consent Order; Capralactone modified by 03/25/86
hydroxyethyl methacrylate (P86-164) -
requires protective clothing to control worker
exposure pending development of information.
Consent Order; Aliphatic diurethane acrylate 04/01/86
ester (P85-1013) - requires protective equipment,
clothing, and respirators to control worker
exposure pending development of information.
Consent Order; Unsaturated acid and heterocyclic 04/01/86
modified epoxy resin (P85-1425) - requires
protective equipment, clothing, and respirators
to control worker exposure pending development
of information.
Consent Order with Testing Trigger; Benzoic acid, 04/03/86
2-((3A,4,5,6,7,7A-hexahydro-5(or 6) methoxy-
4,7-methanoindan)-methyidene)amino, methyl ester
(P85-1210) - requires a production volume trigger
at which time the Company must submit acute
ecotoxicity studies.
Consent Order with Testing Trigger, Benzoic acid, 04/03/86
2-(3-phenyl,butylidene)amino, methyl ester (P85-
1211) - requires a production vo.lume trigger at
which time the Company must submit acute toxicity
studies.
113
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Consent Order with Testing Trigger; Benzoic acid, 04/03/86
2-(3-(4-methyl,cyc1ohex-3-enyl)butylidene)amino,
methyl ester (P85-1212) - requires a production
volume trigger at which time the Company must
submit acute toxicity studies.
Consent Order; Substituted alky! alkanol (P85- 04/05/86
822) - requires protective equipment to control
worker exposure pending development of information.
Consent Order; Substituted pyridine (P84-1219.) - 04/09/86
requires protective clothing respirators and
gloves to control worker exposure pending
development of information.
Consent Order; 3-Chloro-2,6-dinitro-N,N-dipropyl- 04/09/86
4-(trifluoromethyl)-benzenamine (P86-83) - requires
protective equipment and clothing to control worker
exposure pending development of information.
Consent Order;- Acid modified acrylated epoxide 04/11/86-
(P85-1169) - requires gloves, goggles, protective
clothing, and respirators to control worker
exposure pending development of information.
Consent Order; Acid modified acrylated ha-logenated 04/11/86
epoxide (P85-1170) - requires gloves, goggles,
protective clothing, and respirators, to control
worker exposure pending development of information.
Consent Order with Testing Trigger; Sodium salt 04/28/.86
of an alkylated, sulfonated aromatic (P84-591) -
requires a production volume trigger, at which
time the Company must submit chronic ecotoxicity
testing.
Consent Order; Tert-amyl peroxy alkylene ester 05/23/86
(P85-1180) - requires protective clothing and gloves
to control worker exposure pending development of
information.
Consent Order; Polymeric aliphatic polyol 06/05/86
acrylate ester (P85-159/160/161/162) - requires
gloves, goggles, protective clothing, and res-
pirators to control worker exposure pending
development of information.
Consent Order; Substituted acrylated alkoxylated 06/09/86
aliphatic polyol (P86-346) - requires protective
equipment to control worker exposure pending
development of information.
114
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Consent Order; Substituted alkyl aniline (P85- 06/13/86
1420) - requires protective equipment, clothing,
and respirators to control worker exposure pending
development of information.
Consent Order; Substituted pyridine (P85-236) - 06/15/86
requires protective equipment, clothing, and
respirators to control worker exposure pending
development of information.
Consent Order with Testing Trigger; 1-Propanol, 06/16/86
3-mercapto- (P85-433) - requires protective
equipment, clothing, and respirators to control
worker exposure. The Consent Order includes a
testing trigger for a developmental toxicity
study.
Consent Order with Testing Trigger; Ethenyl silane 07/11/86
ester (P85-1369) - requires 90-day subchronic test
after reaching specified aggregate production
volume.
Consent Order; Modified acrylic ester (P86-387) - 07/11/86
requires worker protective clothing and use of a
NIOSH-approved respirator, plus warning statements
and MSDS.
Consent Order; N-Nitrosophenylhydroxylamine, 07/24/86
ethanolamine salt (P86-542) - requires worker
protective clothing, warning statements and MSDS.
Consent Order with Testing Trigger; Benzothiazole- 08/12/86
sulfonic acid, substituted-((substituted-pyrimidinyl)
azo)carbamonocycle-, alkali metal salt (P85-994) -
requires use of worker protective equipment during
manufacturing and processing.
Consent Order with Testing Trigger; Alkyl(hetero-
cyclicylJphenylazo-heteromonocyclicpolyone (85-
1370) - requires standard development toxicity test
in two mammalian species after reaching aggregate
combined production volume of the PMN substance.
Consent Order with Testing Trigger; Alkyl unsub-
stituted spiro heterocyclic (P86-136) - requires use
of worker protective equipment during manufacturing
and processing.
08/12/86
08/12/86
Consent Order with Testing Trigger; Triglycidyl
ether of substituted tri(hydroxyphenylJmethane
(P85-854/855) - requires 90-day subchronic test
one species after reaching specified production
volume.
08/15/86
in
115
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Consent Order with Testing Trigger; Triglycidyl ether 08/15/86
of a substituted tri(hydroxyphenyl) methane (P85-973) -
requires 90-day subchronic test in one species after
reaching specified production volume.
Consent Order with Testing Trigger; Modified tris- 08/15/86
phenol epoxy novolac (P86-382) - requires use of
worker protective equipment, including impervious
gloves, safety goggles and protective clothing.
Training and warning statements are also required,
and MSDS.
Consent Order with Testing Trigger; 1,3,5-Triazine- 08/19/86
2,4,6(lh,3h,5h)-trione, l,3,5-tris(2,3-dibromo-
propyl) (P84-900) - requires worker protective
equipment, use of approved respirator, warning,
labelling. Production volume trigger requires 2-
generation reproduction study.
Consent Order with Testing Trigger; Methyltris 08/25/86
(1-methylethyl )benzene (P86"-124) - requi res" two-
tiered testing after reaching specified aggregate pro-
duction volume. Tier 1 test requirements are acute and
chronic aquatic studies. Tier 2 requires 90-day oral
subchronic and a fish bioconcentration test. Requires
worker protect!v-e equipment, including protective
clothing-and respirators; and. restrict.ron of releases
to approved sites. • ' .
Consent Order; Poly(oxy~l,2-ethaned1yl),alpha(l-oxo- 09/08/86
2-propenyl)omega-(dodecyloxy)- (P86-554) - requires
protective equipment, notification, labelling and MSDS.
Consent Order; Poly(oxy-l,2-ethanediyl),A-(2-methyl-l- 09/08/86
oxo-2-propenyl)-w-(dodecyloxy)- (P86-588) - requires pro-
tective equipment, notification, labelling and MSDS.
Consent Order; Methacrylic ester (P86-650) - requires 09/25/86
worker protective equipment, MSDS and labelling.
Unilateral Action; vinyl chloride - vinyl acetate 04/22/86
hydroxyl modified copolymer (P85-1388) - bans chemical
to control worker exposure. Unable to address health
concerns without additional data.
116
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5(h)(3)
6(e)
8(a)
8(b)
Revisions of Premanufacture Notification 04/22/86
Regulations (Final Rule)
Asbestos; Proposed Mining and Import Restrictions 01/29/86
and Proposed Manufacturing, Importation and
Processing Prohibitions (Proposed Rule)
Asbestos Abatement Projects (Final Rule) 04/25/86
Asbestos-Containing Materials in Schools; Inspec- 08/12/86
tion, Notification, Management Plans, and Technical
Assistance (Advance Notice of Proposed Rulemaking)
Response to Exemption Petitions (PCBs) (Final Rule) 08/08/86
Partial Updating of TSCA Inventory Data Base; 06/12/86
Production and Site Reports (Final Rule)
Anthraquinone Reporting and Recordkeeping Require- 11/06/85
ments (Proposed Rule)
P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene, 11/07/85
P-Tertr-Butylbenzaldehyde; Reporting and Record-
keeping Requirements (Proposed Rule)
Hexachloronorbornadiene; Submission of Notice of 11/19/85
Manufacture, Import, or Processing (and Deter-
mination of Significant New Use)
Additiorrof 17th ITC Report Chemicals to the 11/19/85
Section 8(a) Preliminary Assessment Information
Rule (Final Rule)
Polyhalogenated Dibenzo-p-dioxins/Dibenzofurans; 12/19/85
Reporting Requirements (Proposed Rule)
4,4'-Methylenebis(2-Chloroaniline); Reporting and 04/18/86
Recordkeeping Requirements (Final Rule)
P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene, 05/12/86
P-Tert-Butylbenzaldehyde; Reporting and
Recordkeeping Requirements (Final Rule)
Addition of 18th ITC Report Chemical to the 05/19/86
Section 8(a) Preliminary Assessment Information
Rule (Final Rule)
11-Aminoundecanoic Acid; Recordkeeping Requirements 07/22/86
(Proposed Rule)
Chemical Assessment Information Rule (Proposed 10/07/86
Rule)
Chemical Substances Inventory; Removal of 104 10/11/85
Incorrectly Reported Chemical Substances from the
TSCA Inventory
117
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8(c)
8(d)
9(a)
9(d)
Records and Reports of Allegations of Significant 11/13/85
Adverse Reactions to Health or the Environment
(Final Rule)
Health and Safety Data Reporting; Urea-Formaldehyde 11/07/85
Resins (Final Rule)
P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene, 11/07/85
P-Tert-Butylbenzaldehyde; Health and Safety Data
Reporting Rule (Proposed Rule)
Addition of 17th ITC Report Chemicals to the 11/19/85
Section 8(d| Health and Safety Data Reporting Rule
(Final Rule)
Polyhalogenated Dibenzo-p-dioxins/Dibenzofurans; 12/19/85
Reporting Requirements (Proposed Rule)
Submissions of Lists and Copies of Health and 12/27/85
Safety Studies on Vinyl Acetate (Final Rule)
Health and Safety Data Reporting; Hexachlorocyclo- 01/09/86
pentadiene (Final Rule)
Submission of Lists and Copies of Health 'and Safety 01/22/86
Studies on Certain Substances Subject to the 1984
RCRA Amendments (Final Rule)
P-Tert-8utylbenzoic Acid, P-Tert-Butyltoluene, 05/12/86
P-Tert-Butylbenzaldehyde; Health and Safety Data
Reporting Rule (Final Rule)
Addition of 18th ITC Report chemical to the Section 05/19/86
8(d) Health and Safety Data Reporting Rule (Final
Rule)
Health and Safety Data Reporting; Submission of 08/01/86
Lists and Copies of Health and Safety Studies on
Certain Substances (Proposed Rule)
Health and Safety Data Reporting Submission of 09/15/86
Lists and Copies (Final Rule)
1,3-Butadiene; Decision to Report to the 10/10/85
Occupational Safety and Health Administration
2-Methoxyethanol, 2-Ethoxyethanol and Their 05/20/86
Acetates; Referral for Additional Action
Formaldehyde; Termination of Regulatory Investi- 03/19/86
gation Concerned with Occupational Exposure
4,4'-Methylene Bis(2-Chloroaniline); Termination of 06/23/86
Regulatory Investigation
118
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To!uenediamines; Termination of Regulatory 07/22/86
Investigation Concerned with Occupational Exposure
21 Guidance for Petitioning the EPA under Section 21 11/13/85
of TSCA
26(b) Toxic and Hazardous Substances; Premanufacture 07/11/86
Notice Fees
CHEMICAL ADVISORIES
Burning Used Oil 11/86
Toluenediamines 09/86
119
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Appendix C
Chemical Hazard Information Profiles (CHIPs)
Acrylic Acid 2
Brominated Diphenyl Ethers (12 chemicals)
C.I. Basic Red 9 Monohydrochloride
Chlorendic Acid/Anhydride (2 chemicals)
Chlorinated Styrenes (9 chemicals)
Chlorobromoethane
Diisopropyl Sulfate
Hexaf1uoroi sobutylene
Nitropropane 2
Organosilanes (22 chemicals)
Appendix D
Substitute. Hazard Profiles.
Triethanolamine
N ,N' -Methyl enebi sacry 1-ami de
Ammonium Persulfate
Carbon (fibers)
Wollastonite
Ethanol
Methanol
Isopropanol
Acetone
1-Butanol
Kerosene
Mineral Spirits
Stoddard Solvent
Cure-Rite 18
Tetrachlorophthalic Anhydride
Dibromoneopentyl Glycol
Tetrabromophthalic Anhydride
120
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Appendix E
Section 4 Test Studies* Received
Aryl phosphates (2 studies)
Propylene oxide
Tri s(2-ethylhexyl)trimel1itate
(7 studies)
Hydroquinone (7 studies)
1,3-Dfoxolane
Antimony trioxide (3 studies)
2-Chlorotoluene (3 studies)
Di(2-ethylhexyl)terephthalate
D1(2-ethylhexyljphthalate (2 studies)
Chlorotoluene (mixture)
Cyclohexanone (7 studies)
Di-(n-heptyl, nonyl, n-octyl undecyl)
phthalate (2 studies)
Di-isodecyl phthalate (4 studies)
D'i-undecyl phthalate (4 studies)
Vinylidene fluoride
Trichloroethane
2-Mercaptobenzot:hi azol e
2-Mercaptobenzot:hiazole disu] fide
*97 studies on 24 chemicals
Di-methyl phthalate (2 studies)
Di-n-butyl phthalate (3 studies)
Di-(n-hexyl, n-octyl, n-decyl)
phthalate (3 studies)
Di-isononyl phthalate (4 studies)
o-Phenylenediamines (4 studies)
m-Phenylenediamines (5 studies)
p-Phenylenediamines (5 studies)
Butyl benzyl phthalate (6 studies)
2-Ethylhexanol
Mono-2-ethylhexyl phthalate
Bis(2-ethylhexyl jtrlmellitate
(7 studies)
Hexafluoropropylene oxide
Acrylamide
Di-(2-ethylhexyl)adipate
Di-(n-heptyl , n-nonyl, n-undecyl)
phthalate (2 studies)
.Acrylamide monomer (2 studies)
Appendix F
NTP Studies
National Toxicology Program (NTP) Studies Reviewed
l-Chloro-2-methylpropene (Dimethylvinyl Chloride)
Ampicillin trihydrate
Chloropheniramine maleate
Oxytetracycline hydrochloride
Methyl methacrylate
1,1,2-Tri chloroethylene
Decabromodiphenyl oxide
Chlorendic acid
Pentachloronitrobenzene
Boric acid
1,4-Dichlorobenzene
Tetra kis(hydroxymethyl)
Tetra kis(hydroxymethyl)
PhenyTephrene hydrochloride
Mixed xylenes
Rotenone
Dimethyl methylphosphonate
Methyl carbamate
Bromodichloromethane
Ethylene oxide
phosphonium chloride
phosphonium sulfate
121
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Appendix G
Date
Filed
FY 1986 Section 21 Citizens' Petitions
Who
Filed
Action Requested
EPA's
Disposition
Date of
Disposition
3/7/86
Chemical
Waste
Management
That EPA amend its
PCB disposal regula-
tions to clarify
that materials at
the Model City
facility may be
legally landfilled
withdrawn
06/13/86
11/20/85
Citizens for
Healthy
Progress
12/09/85 Valley Watch
04/29/86
08/18/86
Chemical
Manufacturers
Association
Standard
Chlorine
Chemical
Co., Inc.
That EPA halt the
construction of a
PCB disposal
facil-ity planned for
Henderson, KY
That EPA issue
either a "proposed
order" under section
5(e), or.an injunction
prohibiting, the
construction of
the Henderson
facility
That EPA reconsider
and withdraw Phase 1
test rule for
mesityl oxide
That EPA reconsider
the.test require-
ment for 1,2,4,5-
tetrachlorobenzene
denial
denial
denial
02/24/86
(51FR6423)
02/24/86
(51FR6423)
08/25/86
(51FR30216)
pending
as of 9/30/86
122
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Appendix H
Summary of Research and Development Activities
FY 1986 Accomplishments
A. TEST METHOD DEVELOPMENT
ENVIRONMENTAL PROCESSES
o Report on techniques for effects and update of sediment-associated
toxic chemicals by Benthic Marine Species. 06/86
o Report on the Fathead minnow as a surrogate for other aquatic species.
07/86
o Report on use of relative, position-specific efficiency measurement of
benzo(a)pyrene metabolism as field indicators of carcinogenicity stress
aquatic environment. 09/86
HEALTH
o Complete development of two immunotoxicity assays in an-imals. 09/86
o Journal article on growth enhancement of human bronchial epithelial
cells by nickel sulfate. 09/86
o Journal article on the use of a renal concentration test in the
neonate as a predictor of long-term alterations. in urogenital
morphology. 09/86
B. HEALTH: MAiRKERS. DOSIMETRY, EXTRAPOLATION
o Predictive models for dose effects of asbestiform minerals. 09/86
o Journal article on the review and analysis of the literature of
select chemicals and the establishment of the gene-tox data base.
07/86
o Journal article on metabolism of benzo(a)pyrene in monolayer cultures
of human bronchial epithelial cells from a series of donors. 03/86
o Journal article on interspecies comparison of adult to developmental
toxicity ratios. 08/86
C. SPECIAL HUMAN DATA NEEDS
o Proceedings of conference on medical screening and monitoring for
effects of chemical exposure in the workplace. 09/86
123
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D. ECOLOGY: TRANSPORT, FATE AND FIELD VALIDATION
ENVIRONMENTAL PROCESSES
o Journal article on environmental factors governing the kinetics of
abiotic reduction transformation. 12/85
o Journal article on light-induced oxidation of pollutants involving
natural inorganic species. 12/85
o Progress report on evaluation of Leffler & Taub microcosms for
screening chemicals. 01/86
o Report on the influence of scale in marine microcosms perturbed by
toxic chemicals derived from laboratory microcosms. 03/86
o Journal article on exposure study of organics in Delaware River using
TOXIWASP. 04/86
o Journal article on SAR at the ecosystem levels single: species
relative toxicity vs. ecosystem level toxicity using microcosms. 08/86
o Report on suitability of biodegradation information from fate screen
tests for predicting fate of toxic organic compounds in microcosms and'
field studies.. 09/86
E. ENGINEERING-
o Preliminary assessment of predictive techniques for extraction,.
flaking, and agglomeration unit operations. 01/86
o Evaluations of procedures and methodology of asbestos abatement.
03/86
F. EXPOSURE MONITORING
o Interim report on pollutant sources and human exposure to toxic
pollutants using TEAM Data - FY 86. 12/85
G. STRUCTURE-ACTIVITY RELATIONSHIPS
HEALTH
o Report on how to use molecular electrostatic potential to make risk
assessments on chemically induced toxicity for one class of chemicals.
09/86
o Report on SAR studies on azoreductase II. 09/86
124
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ENVIRONMENTAL PROCESSES
o Report on a comprehensive structure-toxicity method to estimate toxicity
of chemicals to aquatic organisms. 03/86
o Report on SAR methods to predict major metabolites of industrial
chemicals. 08/86
o Report on SAR identification of.potential tumorogenic industrial
chemicals. 09/86
o Journal article describing relationships between microbial degradation
rate constants and chemical properties. 09/86
H. BIOTECHNOLOGY
ENVIRONMENTAL PROCESSES
o Report on data base for detecting, identifying, and enumerating novel
organisms in terrestrial environments. 01/86
o Report on development of data base assessing genetic stability of
novel organisms. 02/86
ECOLOGY: ECOTOXICITY AND- RISK ASSESSMENT
ENVIRONMENTAL.PROCESSES
o Journal article on model developed to describe exchange of non-polar
hydrophobic toxicants across fish gills. 08/86
o Computer program of gill exchange model for predicting bioaccumulation
of hydrophobic xenobiotic chemicals. 09/86
J. SUPPORT
MONITORING
o Guidelines for field testing soil, date, and transport models - Final
report. 04/86
o Report on Asbestos Audit Program. 09/86
ENVIRONMENTAL PROCESSES
0 Final report on chronic toxicity of phthalate esters to Daphnia
and Fathead minnows. 03/86
125
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