United States Pesticides And 21T-2001
Environmental Protection Toxic Substances December 1990
Agency (TS-799)
&EPA Accomplishments
And Goals In Reducing
Toxic Chemical Risk
FY1989 Report To Congress
On The Toxic Substances
Control Act (TSCA)
(Including Activities Under Section 313, Emergency
Planning And Community-Right-To-Know Act Of 1986)
Printed on Recycled Paper
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CONTENTS
Page
Foreword iii
Highlights of Fiscal 1989 1
Section I - Understanding Toxic Chemical Risk 10
1. Scope of the Toxic Chemical Risk Problem 11
2. Nature of Toxic Chemical Risk 16
3. Role of TSCA and Associated Laws in Toxic 23
Chemical Risk Management
Section II — Program Accomplishments and Strategies 30
4. Testing Existing Chemicals 31
5. Controlling Entry of New Chemicals 35
6. Role of Information in Managing Toxic 44
Chemical Risk
7. Assessing and Managing Toxic Chemical Risk 56
8. Compliance and Enforcement 74
9. Litigation 79
10. Relationship of TSCA to Other Federal 82
and International Activities
11. Research and Development 88
12. Other TSCA-Related Activities 96
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Page
Section III — Appendices 100
A Major Fiscal 1989 TSCA Actions 101
B Chemical Data Received Under TSCA Section 4(d) 109
in Fiscal 1989
C Summary of TSCA Section 4 Chemical Testing 110
Actions in Fiscal 1989
D Summary of New CheMcal Actions in Fiscal 1989 112
E Summary of TSCA JSe'etion 8 Information 114
Submissions and Actions in Fiscal 1989
F Summary of the ASHAA Loan and Grant Program, 115
Fiscal 1985-89
G Civil Enforcement Actions - Expanded Case 116
/ Summaries
H Citizens' Petitions and Other Litigation 130
I Summary of Research and Development Activities 142
Fiscal 1989 Accomplishments
J Major TSCA-related Reports Published in Fiscal 146
1989
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FOREWORD
The Toxic Substances Control Act of 1976 (TSCA), Public Law
94-469, authorized the Environmental Protection Agency (EPA) to
identify and regulate chemical substances and mixtures that pose
an unreasonable risk of injury or imminent hazard to health or
the environment. This report, which covers fiscal year 1989, is
the eleventh report to Congress on EPA's administration of TSCA
as required in sections 30, 9(d), and 28(c) of the act.
In addition to discussing accomplishments during fiscal
1989, this year's report also discusses EPA's initiatives and
strategic outlook for reducing the risk from toxic substances and
preventing toxic pollution under TSCA and associated laws.
Section I (chapters 1, 2, and 3) places the discussion
in the context of the national problem of controlling
toxic risk. The chapters provide background on the
scope of the toxic risk problem, the nature of toxic
risk and the role of TSCA and associated laws in
chemical risk management and pollution prevention.
• Section II (chapters 4 through 12) addresses EPA program
activities dealing with different aspects of the toxic
risk problem, integrating into the discussion what has
been accomplished, what goals have been set, and what
strategies are being considered to achieve these goals
in the 1990s.
Section III contains appendices which provide additional
detail on program accomplishments.
This report does not include activities under TSCA Title
III (the Indoor Radon Abatement Act, Public Law 100-551). Those
activities are reported on separately by EPA's Office of Air and
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Radiation Programs in its Report to Congress on Radon Assessment
and Mitigation Under Section 118(k). the Superfund Amendments and
Reauthorization Act of 1986 (SARA).
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HIGHLIGHTS OF FISCAL 1989
In carrying out its mandates under the laws it implements to
control toxic chemical use, EPA's Office of Toxic Substances has
set the following major goals:
to ensure that new chemicals, including products of
biotechnology, do not enter commerce without appropriate
controls;
to identify existing chemicals that pose unreasonable risks;
to reduce risks from future marketing and use of existing
chemicals;
to remove especially toxic chemicals, such as asbestos and
polychlorinated biphenyls (PCBs), from continued use;
to ensure strong compliance with and research and development
in support of these goals.
Some highlights of agency actions taken in fiscal 1989 to
advance these goals follow. (These actions—and many others—are
discussed in greater detail in the body of this report.)
Ensuring Control of New Chemicals
The New Chemicals Program is one of the agency's principal
pollution prevention programs. Its function is to prevent
potential chemical pollutants that have been determined to be
hazardous to human health or the environment from entering
commerce or the environment.
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In fiscal 1989, the agency received over 1,000
premanufacture notices (PMNs), increasing the total
since TSCA's enactment to 12,600. EPA also received
voluntarily submitted test data for 53 chemicals and
data on eight chemicals as a result of consent orders.
EPA implemented its exposure-based policy for testing
new chemicals in fiscal 1989. This policy requires
basic toxicity testing of new chemicals that exceed set
production volume, exposure, or release criteria,
regardless of the chemical's structural characteristics.
The agency took steps to make regulation of new
chemicals and new chemical uses more efficient: (1) it
adopted new procedures that significantly expedite the
negotiation and promulgation of consent orders; (2) it
published a "generic" rule that makes regulation of new
uses of chemicals much more efficient.
Identifying Existing Chemicals That Pose Unreasonable Risk
The Existing Chemicals Program uses a multifaceted strategy
to identify which of the thousands of existing chemicals pose
unreasonable risks. The components of that strategy are the
following:
screening new data on chemicals to identify new hazards;
collecting data from industry on manufacturing and use
of chemicals of concern;
requiring industry to conduct studies to fill data gaps
on chemicals of concern;
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collecting data on annual emissions and discharges of
toxic chemicals and making those data available to the
public and to other environmental programs at the
federal, state, and local levels;
conducting risk assessments on suspect chemicals to
determine whether controls should be imposed on their
future use.
Highlights of fiscal 1989 EPA efforts to identify existing
chemicals that pose unreasonable risk include the following:
The first public release of Toxics Release Inventory
(TRI) data, for the 1987 reporting year, occurred in
fiscal 1989. (Although the TRI is required not under
TSCA, but under section 313 of the Emergency Planning
and Community Right-to-Know Act of 1986 [EPCRAJ, which
is title III of SARA, the program is being implemented
by the Office of Toxic Substances and the data the
program provides are used extensively to implement
TSCA.) TRI data are self-reported industry estimates of
releases to air, water, and land and of transfers for
disposal of over 300 chemicals and chemical categories.
For the 1987 reporting year, over 19,000 facilities
across the United States submitted TRI reports.
Particular efforts were made to help states, other
federal agencies, interest groups, and the public obtain
access to, interpret, and use TRI data for toxic
chemical risk screening and management. The agency
published the information submitted, in summarized form,
in The Toxics Release Inventory: A National
Perspective. which was made available to the public.
A number of major risk assessment and risk management
support activities were initiated or were in progress in
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fiscal 1989, including ones concerning CFC substitutes,
inhalation exposure to formaldehyde, inert ingredients
in pesticides, polychlorinated dibenzo-p-dioxins
(PCDDs), polychlorinated dibenzofurans (PCDFs), dioxin
in paper, and substitutes for acrylamide grouts.
Test data received by EPA in fiscal 1989 increased by 25
percent over previous years. In addition, the chemical
testing program initiated several major activities
important to future progress in the program, including
(1) streamlining the program to enable other EPA
programs, including Superfund, to nominate chemicals for
testing; (2) negotiating programs with chemical trade
associations that allow EPA to obtain information useful
to both the Existing and New Chemicals Programs; and (3)
promulgating a testing exemption rule for chemicals used
in research and development and for low-volume
chemicals.
Reducing Risks from Marketing and Use of Existing Chemicals
The Existing Chemicals Program focuses on chemicals for which
there is maximum potential for reducing risks through government
intervention and that cannot be controlled effectively by other
federal regulatory programs. Some examples of fiscal 1989 work
in this area follow:
Safe use and disposal of PCBs still in service remain
the principal focus of the PCB program. In fiscal 1989,
the agency also directed attention to high-volume/low-
concentration problems related to PCBs, such as those
associated with non-metallic debris ("fluff") from
shredding automobiles and household appliances and with
groundwater contamination caused by improper disposal of
PCB condensate from natural gas pipelines.
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By the end of fiscal 1989, as a result of EPA's efforts
to ensure compliance with the requirements of the
Asbestos Hazard Emergency Response Act (AHERA), 94
percent of the nation's schools had completed asbestos
inspections and developed asbestos management plans. To
date, EPA has approved over 1,300 accreditation training
courses and 15 state accreditation programs to establish
an infrastructure of trained asbestos inspectors,
planners, and supervisory personnel. In concert with
the National Education Association and the National
Parent Teachers Association, EPA published The ABCs of
Asbestos in Schools to inform parents and teachers about
asbestos and the responsibilities of school officials
under AHERA.
In support of asbestos abatement programs in schools,
EPA awarded $45 million in loans and grants under the
Asbestos School Hazard Abatement Act (ASHAA) in fiscal
1989 to help needy schools control asbestos risks.
Since 1985, over $200 million in ASHAA funds have been
issued for 2,200 abatement projects, which have the
potential to reduce students' and employees' exposure to
asbestos by more than 17 million exposure-hours a week.
A cross-program effort was under way in fiscal 1989 to
explore the use of TSCA section 6(a) to encourage the
recycling of lead-containing products. The agency is
also considering use of TSCA authorities to reinforce
existing proscriptions on the use of lead solder in
potable water plumbing. In addition, EPA is helping the
U.S. Department of Housing and Urban Development (HUD)
in its effort to mitigate risk from lead-based paint by
(1) developing information for a demonstration of
techniques for abating lead-based paint problems in
single- and multi-family housing, for conducting a
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national survey of the lead-based paint hazard in
housing, and for a comprehensive plan to address the
hazard; and (2) training program administration
personnel and abatement contractors and designers.
Removing Unreasonably Toxic Chemicals from Continued Use
Because some chemicals pose such an unreasonable risk that
controls on their use are not sufficient to protect the
environment and public health, those chemicals must be removed
from continued use.
In July 1989, EPA published the Asbestos Ban and Phase-
out Rule, which bans the manufacture, importation, and
processing of about 94 percent of asbestos products by
1997. This regulation will reduce long-term
environmental contamination by asbestos and exposures
that pose serious health problems.
In fiscal 1989, EPA prepared final action (issued in
January 1990 and effective in May 1990) to prohibit the
use of hexavalent chromium, a potent human carcinogen,
in comfort cooling towers, which are an integral part of
heating, ventilation, and air conditioning systems.
Ensuring Strong Compliance
The toxic substances enforcement program consists primarily
of a nationwide program of compliance inspections using federal,
state, and contractor support. Highlights of fiscal 1989
compliance and enforcement activities include the following:
Cooperative programs to monitor compliance with PCB and
asbestos regulations continued. States conducted about
1,300 asbestos compliance inspections and about 800 PCB
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compliance inspections. In cooperation with 16 states,
EPA conducted over 2,400 PCB compliance monitoring
inspections and 1,500 asbestos inspections.
EPA issued 415 administrative complaints under TSCA in
fiscal 1989. The agency completed another 319 civil
actions and collected over $4 million in penalties.
Fiscal 1989 marked the first full year of enforcement of
TRI reporting requirements. EPA conducted more than 750
on-site inspections, issued more than 110 administrative
complaints, and proposed total penalties exceeding $4
million. In two major enforcement campaigns, EPA filed
coast-to-coast complaints that encouraged greater
compliance by industry-
Research and Development
EPA's Office of Research and Development supports the toxic
substances program with work aimed at developing, evaluating, and
validating health and environmental test methodologies and
procedures to improve the predictability of risk estimates,
develop exposure monitoring systems, devise environmental fate
and effects methods, and provide guidelines for risk assessments.
In fiscal 1989, research and development activities associated
with the toxic substances program included the following:
developing a model for assessing indoor air exposure to
such chemicals as formaldehyde and chlorinated solvents.
developing short-term, cost-effective predictive methods
for detecting and assessing toxic effects of chemicals.
developing structure-activity relationships (SARs),
through which chemicals can be categorized and grouped,
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on the basis of similar molecular structures, for more
rapid determination of probable toxicity and risk.
establishing a scientific information resource to
provide more insight into how plants, animals, and
ecosystems are affected by toxic substances.
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The Environmental Protection Agency's Office of
Toxic Substances implements programs under four
environmental statutes, all focused on control of toxic
chemical use.
The Toxic Substances Control Act (TSCA) gives EPA
the authority and responsibility to protect human
health and the environment from unreasonable risks
arising from the manufacture, distribution in
commerce, use, or disposal of existing and new
chemicals.
The Asbestos School Hazard Abatement Act (ASHAA)
directs EPA to help states and local education
agencies determine the extent of risks from exposure
to asbestos-containing materials in schools.
• The Asbestos Hazard Emergency Response Act (AHERA),
title II of TSCA, establishes inspection and
abatement requirements for all public and private
elementary and secondary schools and requires that
EPA examine the issue of asbestos in public and
commercial buildings.
Section 313 of the Emergency Planning and Community
Right-to-Know Act (EPCRA) of 1986 requires EPA to
establish an inventory of toxic chemical emissions
from certain facilities.
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SECTION I.
UNDERSTANDING TOXIC CHEMICAL RISK
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1. SCOPE OP THE TOXIC CHEMICAL RISK PROBLEM
This chapter discusses the scope of the national toxic
chemical risk problem in terms of the number of chemicals in
commerce, production volumes, uses, examples of the presence of
toxic chemicals in the environment, and the need for chemical
testing and risk assessment.
Chemical Inventories
TSCA chemical inventory. This inventory, compiled by EPA in
accordance with TSCA, lists more than 68,000 chemicals
manufactured or processed in the United States since 1975. About
6,200, less than 10 percent, have undergone some review by the
toxic substances program. A few hundred of these are regulated
by federal and state environmental programs. Of the chemicals
which have not been reviewed by EPA, almost two-thirds (about 64
percent) are currently produced in levels below 10,000 pounds per
year and thus are not considered priority chemicals. One-third
of the 36 percent of chemicals not yet reviewed but produced in
excess of 10,000 pounds per year are polymers, which are
generally viewed as being of less concern. This leaves
approximately 14,000 substances on which EPA attention is focused
either because of their nature or their production in high
volumes. Little or nothing is known about exposure potential or
hazard of most of these chemicals.
Adding to the magnitude of managing chemical information are
thousands of new chemicals developed annually for commercial use.
Some of these may be toxic and may present unreasonable risks to
health or the environment if not controlled. Most new chemicals
have little toxicity data when they are ready to go into use, and
economic forces within the marketplace are insufficient to lead
to elimination of unreasonable risk. Controls on the entry of
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new chemicals are therefore necessary to protect public health
and the environment.
Toxics Release Inventory. In response to new requirements
imposed by section 313 of EPCRA, manufacturers and processors
reported that more than 22 billion pounds of 328 toxic chemicals
and chemical categories were released or transferred for disposal
in 1987. (Certain high-volume, low-toxicity chemicals have
subsequently been removed from TRI reporting requirements. If
these chemicals were removed from the 1987 TRI, the numbers
reported for that year would be reduced to 6.97 billion pounds.)
Successively smaller reporting thresholds take effect under EPCRA
in 1988 and 1989, and more firms will be brought into compliance
with reporting requirements. Sufficient exposure to chemicals
covered by section 313 may present a risk of acute or chronic
adverse health and environmental effects. All levels of
government, as well as the general public, can access and use the
TRI database in developing action to reduce exposure to toxic
chemicals.
Examples of Toxic Chemicals in the Environment
Asbestos and PCBs have been the subject of special concern,
in law and regulation, for the past 20 to 30 years. They have
been targets of large regulatory efforts in EPA and provide
important examples of the scope and complexity of the problem of
assessing and eliminating unreasonable toxic chemical risk.
Asbestos. The "magic mineral" is a naturally occurring
family of fibers, which are heat-resistant, odorless, and very
durable. Because of these attributes, asbestos has found
widespread use in both construction and industry. It is also
carcinogenic to humans and in occupational settings can cause a
chronic lung disorder, known as asbestosis, and other disease.
The potential for harm to people from asbestos depends largely
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upon exposure factors—where it is located, the type, frequency,
and severity of disturbances to which it is subjected, and
whether the material is damaged and to what extent.
Surveys conducted by EPA indicate that asbestos-containing
material (ACM) is found in about 31,000 schools and 733,000 other
public and commercial buildings nationwide.1 About half these
buildings may have at least some damaged ACM, often thermal
system insulation or pipe and boiler wrap in maintenance areas.
It is generally accepted that building occupants have a lower
potential exposure than maintenance and service workers. When
asbestos-containing material is disturbed, however, the
possibility of exposure may increase.
PCBs. The amount of PCBs in service has shown some
decrease. In 1988, EPA estimated that 282 million pounds of PCBs
were in service, down from an estimated 750 million pounds in
1976. (About 1.5 billion pounds of PCBs were produced in the
United States from 1929 until 1976.) Because of their stable
chemical nature and other characteristics, PCBs have found
widespread use as coolants and dielectric fluids in transformers
and capacitors, as heat transfer fluids, and as coatings to
reduce flammability. PCBs were also widely used in paints,
printing inks, dust control agents, and pesticides.
Due to their widespread commercial use and chemical
stability, PCBs have become highly dispersed in the environment.
Measurable amounts can be found in soils, water, and fish
throughout the world. PCBs are also bioaccumulative, and EPA's
National Human Adipose Tissue Survey has revealed detectable
1 Sources: Evaluation of the Asbestos-in-schools Identification
and Notification Rule. 1984, USEPA (No. 560/5-84-005), p. xii;
and Asbestos in Buildings; A National Survey. 1984, USEPA (No.
560/5-84-006), p. ix.
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concentrations in almost all Americans. Exposure to PCBs and
some of their combustion by-products can produce carcinogenic and
other toxic effects.
Congress specifically banned the manufacture of PCBs in the
original enactment of TSCA. It is now clear, however, that
phasing out the use of PCBs in new products and managing the
large stock of concentrated PCBs found in electrical transformers
and capacitors may address only part of a much broader problem.
Throughout the United States, soil and structures are
contaminated with PCBs from past use, and a variety of products
still contain low concentrations of the chemicals. Addressing
these problems requires broader involvement of federal and state
agencies.
Need for Information
Testing and risk assessment. Asbestos and PCBs are
prominent examples of substances in the chemical inventories
whose potential risks to people or the environment are
sufficiently well known to justify regulatory action.
Information about many other chemicals, however, is insufficient
to determine whether regulatory action is necessary- A program
of testing and risk assessment is essential to provide the needed
information. Asbestos substitutes, substitutes for chlorofluoro-
carbons (CFCs), acrylates, formaldehyde, "inert" ingredients in
pesticides, dioxin in wood pulp, brominated flame retardants,
vinyl acetate, and others were the subject of EPA testing and
risk assessment activities in 1989.
Biotechnology. Among new developments are products of
biotechnology, including genetically engineered microorganisms.
While expected to provide significant benefits to society in the
form of drugs, pesticides, agricultural products, and pollutant
degradants, there are concerns about the potential effects of
these new commercial products on health and ecological systems.
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Microorganisms have the ability to spread in the environment,
creating the possibility that they will produce health or
environmental effects distant from the site of release; products
developed in one locality may pose unforeseen risks in another.
The rate of development in biotechnology and the novel health and
environmental issues posed by its commercial products create a
major challenge in acquiring toxicological data and fashioning
new tools for risk assessment and risk management.
NEXT ... Chapter 2 discusses what "toxic chemical risk11 means and
what factors determine the severity of such risk to health and
the environment.
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2. NATURE OF TOXIC CHEMICAL RISK
TSCA Qb-iective: Eliminate Unreasonable Risk
The primary objective of TSCA is the elimination of
unreasonable risk to health or the environment by chemical
substances and mixtures. Reaching this objective does not
necessarily require banning a chemical that poses an unreasonable
risk, nor does it mean maximum risk reduction. Rather, the
requirement is to reduce risk to a reasonable level. This goal
can be achieved either through regulatory or voluntary means
(such as stimulating industry to develop safer substitutes and
reduce unnecessary exposures). Under TSCA, making a finding of
unreasonable risk requires a balancing of risks to health and the
environment against economic and social costs. The first step in
the balancing process is to develop an adequate understanding of
the nature of risk posed by a chemical.
Risk cannot usually be directly monitored or measured.
Rather, risk is assessed from the measurement, modeling, or
analysis of the components of risk—toxicity, potency, dose, and
exposure. Assessing chemical-specific risk is therefore a
complex scientific and technical endeavor.
Components of Risk
Toxicity. This refers to the ability of a chemical to
damage an organism. The risk associated with a toxic chemical is
primarily dependent on the chemical's potency, route of exposure,
dose, and frequency and duration of exposure.2
Potency. This refers to a dose-response relationship (the
concentrations at which a toxic chemical can cause adverse health
2 Chemical Exposures; Effects on Health, EPA, 6/87
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or environmental effects). Potency is chemical-specific and
independent of whether living organisms actually contact the
chemical.
Exposure. This deals with the intensity and duration of
contact by organism with a chemical through eating, drinking,
breathing, or skin contact. Without exposure there is no risk.
Dose. This is the amount of a chemical that enters the
body. A person's susceptibility relative to dose is determined
by whether exposure is to a combination of chemicals as well as
by the exposed person's age, health, nutrition, and history of
previous exposures.
In short, toxic risk is a function of how much of a chemical
an individual is exposed to, how often, for how long a time, and
by what means. Table 2-1 summarizes these and other factors
affecting toxicity.
Acute and Chronic Toxicity
The damaging effects of chemical toxicity may result from an
acute (brief) exposure, or from chronic (repeated or long-term)
exposures.
Acute toxicity. Acute effects often involve high doses over
a period measured in minutes or hours. Some chemicals are
acutely dangerous in very small doses. For many acutely toxic
chemicals, however, effects are often reversible after exposure
stops.
Chronic toxicity= Effects from chronic exposure to toxic
chemicals occur after a long period, 20 or 30 years in the case
of cancers. Information on chronic effects is usually based on
animal studies, which are time consuming, complex, expensive, and
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require extrapolation from high test doses to the lower doses to
which people are exposed. As a consequence of these
complications, chronic effects are unknown for many chemicals.
Risk Assessment
A risk assessment is a scientific evaluation that integrates
information on:
a chemical's adverse effects,
• research estimates of human and environmental
dose-response relationships,
• judgments on the type and number of human and non-human
organisms affected under different conditions of
exposure, and
the uncertainties involved in these estimates and
judgments.
A risk assessment produces a characterization of risk which
provides both qualitative and quantitative estimates of the
nature and probability of damage to humans and other organisms.
Such results are vital inputs to EPA and other organizations that
make decisions to regulate or manage toxic risk.
Next ... Chapter 3 discusses the regulatory authorities which
Congress provided EPA under TSCA and associated laws to manage
toxic chemical risk and prevent toxic pollution.
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Table 2-1. Factors Affecting Toxicity
Properties of the individual chemical
Small differences in chemical structure can produce
large differences in organism's ability to absorb,
metabolize, or excrete a chemical.
Dose, frequency, and duration of exposure
Acute and chronic exposure effects of a chemical may
differ.
Effects are related to ability of organism to detoxify
chemicals.
• Small doses may be tolerated because of organism's
ability to metabolize or excrete a chemical.
Large doses or chronic exposure may produce toxic
effects through bioaccumulation.
Route of exposure
Whether a chemical is inhaled, ingested, or absorbed
through the skin is an important determinant of toxicity
because each produces a different pattern of metabolism,
distribution, or excretion.
Chemicals differ in which route of exposure produces the
most toxic effects.
Some chemicals are blocked by protective barriers (skin,
cilia, etc.), while others are not.
Other environmental exposures
Toxicity is affected by exposure to a combination of
chemicals.
Exposure need not occur at same time to cause
interactive effects.
Interactive effects can be additive, synergistic, or
neutral.
individual susceptibility
Age, sex, nutritional and immunological status, genetic
characteristics, and state of health affect individual
response to toxic chemicals.
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Source: Toxic Chemical Release Inventory Risk Screening
Guide (Version 1.0). Vol.1, EPA560/2-89-002,
EPA/OTS, 7/89,
p. 24
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Table 2-2. Human Health Effects of Toxic Chemicals
Carcinogenic!ty; Ability to cause cancerous tumor formation
in tissue.
Heritable gene and chromosome mutations: Genetic changes
occurring in germ cells, including deficiencies,
duplications, insertions, inversions, and translocations of
chromosomes, as well as gains or losses of whole chromosomes.
Neurotoxicity: Any adverse effect on the structure or
function of the central and/or peripheral nervous system
related to exposure to a chemical substance.
Reproductive and developmental toxic effects; Reproductive
toxic effects are adverse effects on the male or female
reproductive systems, while developmental effects are adverse
effects on the developing organism, including death,
structural abnormalities, altered growth, and functional
deficits (e.g., learning disorders). Developmental toxicity
also includes teratogenic effects, which are structural
abnormalities which may adversely affect a developing
organism.
Other chronic effects; Any adverse effects other than cancer
from long-term repeated chemical exposure.
Adverse and acute effects; Adverse effects are any
deleterious effects suffered by an organism, while acute
effects occur rapidly as a result of short-term exposure to a
high concentration of a chemical.
Source: Toxic Chemical Release Inventory Risk Screening
Guide (Version 1.0). Vol.1, EPA560/2-89-002,
EPA/OTS, 7/89, p. 22
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Table 2-3. Environmental Effects of Toxic Chemicals
• Environmental toxicitv: EPA's indicators of toxicity are
particularly concerned with aquatic and avian acute lethal
effects, and adverse chronic effects through the food chain.
Toxicity and persistence: EPA is especially concerned about
chronic toxicity caused by chemical persistence.
Toxicitv and bioaccumulation; Chemicals with high
bioconcentration factors have a potential for build-up in the
food chain with consequent potential adverse effects on
aquatic, terrestrial, and avian organisms.
Any significant adverse effect on the environment; This
includes "any ecologically significant change in species
interrelationships, such as changes in species behavior,
growth, or survival that, in turn, adversely affect the
behavior, growth or survival of other species" (section 8(e)
of TSCA).
Source: Toxic Chemical Release Inventory Risk Screening Guide
(Version 1.0). Vol.1, EPA560/2-89-002, EPA/OTS, 7/89,
p. 23.
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3. ROLE OF TSCA AND ASSOCIATED LAWS IN TOXIC
CHEMICAL RISK MANAGEMENT
Risk Management
The process of risk management comprises all of the steps
taken by EPA in the course of decisionmaking. It involves risk
assessment (see chapter 2); development of regulatory and
non-regulatory control options; balancing risk against social and
economic factors; and public involvement. Figure 3-1 depicts the
risk management process.
EPA has diverse responsibilities and authorities under TSCA
title I, TSCA title II (AHERA), ASHAA, and EPCRA. Under TSCA
title I, EPA is charged with carrying out the full risk
management process. EPA has the regulatory authority to control
chemicals in all environmental media, including chemicals that
are subject to regulation under certain other environmental
statutes; EPA can:
intervene throughout the chemical lifecycle to reduce
unreasonable risks during manufacturing, processing,
distribution in commerce, use, and disposal;
require testing of existing chemicals that may present
an unreasonable risk to people or the environment;
• require testing of existing chemicals that are produced
in substantial quantities and that enter or may enter
the environment in substantial quantities or which may
have significant or substantial human exposure;
• prevent pollution by regulating new chemicals and new
uses of existing chemicals;
effect cooperation among overlapping legal authorities;
enforce remedies, including chemical product labeling
and outright bans; and
seek penalties and settlements to achieve compliance.
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Figure 3-1. The Process of Risk Management
Development of Potions
• Regulatory
• Non-regulatory
Balancing of Factors
• Risk assessment
• Social and economic
consequences
Public Involvement
• Public comment
• Outreach activities
Decisions and Actions
• By EPA
• By states or localities
• By other risk managers
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The provisions of AHERA, ASHAA, and EPCRA allow EPA to
support the risk management process of other government bodies
and agencies by promulgating regulatory standards, disseminating
information, and providing technical and financial assistance.
Regulation of Asbestos and PCBs
AHERA, passed by Congress in 1986, is one of a group of laws
(including the Clean Air Act, Occupational Safety and Health Act,
and others) that regulates exposure to asbestos in occupational
and non-occupational settings. AHERA requires public school
districts and private schools, called local education agencies,
to inspect their buildings for asbestos hazards, prepare asbestos
management plans, and carry out response actions in accordance
with EPA regulations. Local education agencies must also notify
parent and teacher organizations about the availability of
management plans. Implementation of plans began on July 9, 1989.
AHERA also requires state accreditation of asbestos
inspectors, planners, and abatement workers, and the
certification of testing laboratories in accordance with EPA
standards.
AHERA directed EPA to study and report on asbestos exposure
risks in public and commercial buildings. This was completed in
February 1988 and outlined the agency's short-term plan for
addressing asbestos in these facilities. In addition, the law
established the Asbestos Trust Fund to receive enforcement
penalties and loan and grant repayments from awards made under
ASHAA.
ASHAA, signed into law in 1988, provides loans and grants to
needy schools to abate serious asbestos hazards in their
buildings. Through 1989, about $202 million has been provided to
1,571 schools for nearly 2,200 individual abatement projects.
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Asbestos risks are also managed under section 6 of TSCA,
which has recently been used to ban or phase out future use of
asbestos products. Asbestos risk management efforts may also
involve cross-media cooperation among EPA programs, such as
asbestos air emissions under the Clean Air Act and asbestos
disposal under the Resource Conservation and Recovery Act (RCRA).
As in the case of asbestos in schools under AHERA, Congress
explicitly required regulation of PCBs under TSCA section 6(e).
PCB health and environmental threats are diverse and ubiquitous.
Consequently, while EPA is the primary manager of PCB risks, the
involvement of the states is essential to effective risk
management.
Accomplishments during fiscal 1989 and goals in managing the
risks of asbestos, PCBs, and other substances under TSCA are
discussed in chapter 7.
Toxics Release Inventory
EPCRA section 313 created the TRI, the first and only
multi-media environmental release database, to inform the public
and all levels of government of routine releases of more than 300
toxic chemicals and chemical categories.
Affected businesses included under Standard Industrial
Classification codes 20 through 39 must submit reports annually
to the host state and to EPA on releases from facilities to air,
water, and land. Reporting is required of manufacturers and
processors of at least 75,000 pounds of any of the listed
chemicals during 1987, 50,000 pounds during 1988, and 25,000
pounds during 1989, and of users in any other way of 10,000
pounds or more during those and subsequent years. (Manufacturers
and processors are also required under other sections of EPCRA to
make reports to certain local authorities.) All sources of waste
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are to be considered, including those listed in Table 3-1.
Accomplishments and goals under EPCRA section 313 are
discussed in chapters 6 and 7.
Summary
Taken together, TSCA title I, AHERA, ASHAA, and EPCRA
provide a broad base of authority to develop a more integrated
multi-media, multi-chemical approach to toxic risk management and
pollution prevention. Integration can be accomplished through:
more effective use of information as a risk reduction
tool; and
more cooperation and burden-sharing among the "toxics
community," the domestic and international groups
concerned with control of toxic substances.
Next ... Section II (chapters 4 to 12) discusses fiscal 1989
accomplishments in testing, information management, assessing and
managing toxic risk, and preventing toxic pollution under TSCA
title I, AHERA, ASHAA, and EPCRA. Also discussed are goals and
strategies for instituting improvements in risk management and
pollution prevention over the next several years. Details of
fiscal 1989 accomplishments are supplemented in Section III.
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Table 3-1. Some Sources of Industrial Toxic Chemical Releases
Fugitive or non-point sources
• Equipment leaks from pumps, valves, flanges
• Building ventilation systems
Evaporative losses from surface impoundments
Stack and other point air sources
Vents from reactors and other process vessels
Storage tank vents
Stacks or vents from pollution control equipment
Water sources
Process outfalls
Washings from containers, etc.
Pollution control devices
Stormwater runoff
Solids/ slurries, and non-aqueous sources
Filter cakes
Spent catalysts
Pollution control wastes and treatment sludges
Vessel or tank residues
Spills and sweepings
Spent solvents
Byproducts
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Source. Estimating Releases and Waste Treatment Efficiencies for
the Toxic Release Inventory Report Form, EPA560/
4-88-002, EPA/OTS, 1987
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SECTION II.
PROGRAM ACCOMPLISHMENTS AND STRATEGIES
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4. TESTING EXISTING CHEMICALS
Background
Section 4 of TSCA gives EPA authority to require
manufacturers and processors to test an existing chemical, if EPA
finds that:
the chemical may present an unreasonable risk to health
or the environment, or that the chemical is or will be
produced in substantial quantities, and (a) it may enter
the environment in substantial quanitities, or (b) there
may be significant or substantial human exposure or
substantial environmental release; and
insufficient data exist about health or environmental
effects of the chemical to predict the impacts of its
manufacture, processing, distribution in commerce, use,
or disposal; and
testing is needed to develop data on which to make such
predictions.
If EPA makes these findings for a chemical or category of
chemicals, it can issue a test rule to require tests of health
and environmental effects, chemical fate, or any other test
relevant to risk assessment (i.e., exposure). To expedite the
testing, EPA and test sponsors may agree to an enforceable
consent order.
EPA's Chemical Testing Program was established under section
4 of TSCA. Test priorities for existing chemicals are
recommended to EPA by the Interagency Testing Committee (ITC).
The ITC was established by section 4(e) and consists of
representatives from 18 federal agencies, including EPA. The ITC
categorizes chemicals for testing as either designated or
non-designated. EPA is required under section 4(e) to respond to
ITC-designated chemicals by initiating rulemaking within twelve
months or publish its reasons for not doing so. Non-designated
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chemicals are dealt with expeditiously, but resource constraints
may affect the review process for these chemicals. ITC
recommendations do not exclude EPA from establishing independent
chemical testing priorities.
The ITC and EPA also coordinate priorities for testing with
other federal agencies and international organizations. EPA
routinely reviews the studies of other agencies and the
scientific literature for relevance to the agency's risk
assessment and risk management activities.
Accomplishments During Fiscal 1989
Chemical testing actions. The Chemical Testing Program
noted significant accomplishments in fiscal 1989:
Data on 35 chemicals were received under section 4(a)
test rules (chemicals listed in Appendix B)
Five test rules were proposed
Eight final test rules were issued
Five testing consent orders were issued
Three procedural rules were developed
Appendix C gives details on these rules and consent orders
and on other actions. In addition, 22 testing rules are under
development.
Promulgated test rules and consent orders have generated a
25 percent increase in the amount of data received compared to
previous years. Further increases in data are expected as
laboratories complete ongoing testing and initiate new tests.
EPA estimates that it will cost $5.8 million to $10.9
million for industry to conduct the tests that were required by
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rules promulgated in fiscal 1989. Industry will also bear the
cost for testing required by consent orders.
Initiatives Affecting Future Program Success
Program streamlining. The Chemical Testing Program made its
rulemaking process more efficient to better utilize testing
resources. As a result, it is now accepting the nomination of
chemicals arising from EPA's implementation of other laws, such
as RCRA and SARA, provided they meet the TSCA section 4
requirements described above.
Exemption rule. The Chemical Testing Program amended its
procedural rule in order to treat manufacturers who produce
chemicals in low volume or who produce chemicals for research and
development as processors are treated.
Testing agreements with industry. Negotiations have been
conducted with chemical trade associations to obtain test data on
existing chemicals. This information will be used as a database
to provide analog data for use in TSCA section 5 new chemical
assessments. In May 1989 a consent agreement for acrylates was
negotiated with the Special Acrylates and Methacrylates (SAM)
Panel of the Chemical Manufacturers Association. This agreement
enables EPA to collect data on a large category of chemicals.
The acrylates agreement is discussed more fully in chapter 5.
Strategy for the 1990s
Goals. The challenge for EPA and other members of the
toxics community is to accelerate the pace of screening and
testing of chemicals. In the 14 years since the enactment of
TSCA, relatively few chemicals have been screened. (See chapter
1.) While some of the unscreened chemicals may be polymers or
others of low risk, the large number of remaining unscreened
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chemicals requires us to seek more effective and productive ways
to go beyond managing the risks we know about, to determining
what risks exist and managing these risks.
Means to achieve goals. EPA envisions two strategic steps
to speed up the screening and testing program significantly:
First, the agency needs to develop a priority list for screening
and testing purposes. High-exposure chemicals must be of top
concern because, if they are toxic, high risk will result unless
controls are imposed. Persistent bioaccumulative chemicals
should also get early attention for similar reasons.
Second, the assistance of other agencies and countries in
sharing the burden of screening and toxicity testing will be
essential. To accomplish this, a consortium of domestic and
international organizations will allocate the screening and
testing burden and coordinate the effort. Over time, we can
expect agreement that chemicals entailing high exposure,
environmental release, or other potentially hazardous
characteristics must have a minimum set of test data to remain in
commerce.
See chapter 7 for a fuller discussion of the strategy now
being implemented in the Office of Toxic Substances for
accelerating the pace of existing chemical testing, risk
assessment, and risk management.
NEXT ... Chapter 5 discusses how EPA has used its pollution
prevention authority under section 5 of TSCA to address the risks
posed by new chemicals and new uses of existing chemicals.
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5. CONTROLLING ENTRY OF NEW CHEMICALS
Background
Under TSCA section 5, EPA has the responsibility to review
new chemical substances. New chemicals are defined as those not
on the TSCA chemical inventory, which is EPA's comprehensive list
of chemicals in commerce. Most new chemicals have few toxicity
test data available when they are about to enter commerce. When
EPA has insufficient data to predict a new chemical's health and
environmental effects, the agency can prohibit or limit the
manufacture, processing, distribution, use, or disposal of the
chemical for 90 days pending development of test data if it finds
the chemical may present an unreasonable risk to health or the
environment, or that the chemical is or will be produced in
substantial quantities, and (a) it may enter the environment in
substantial quanitities, or (b) there may be significant or
substantial human exposure or substantial environmental release.
Under section 5(f), EPA may also ban or limit manufacture if a
determination is made that activities involving a new chemical
will present an unreasonable risk.
Under TSCA section 5(a), manufacturers and importers are
required to provide EPA with a premanufacture notice (PMN) at
least 90 days in advance of producing or importing a new chemical
for non-exempt commercial purposes. EPA's New Chemicals Program
reviews and evaluates the potential risk posed by a new chemical
and decides whether controls are appropriate. Some genetically
engineered microorganisms are considered to be new chemical
substances subject to section 5 review.
TSCA does not require prior testing by the manufacturer and,
consequently, most PMNs are not accompanied by toxicological
testing data. In the absence of test data, EPA's evaluation
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relies on SARs, a method of projecting toxicity by using
structure-activity relationships.
In 90 percent of cases, EPA has not acted to limit
commercial production at the end of the 90-day period. In the
remaining 10 percent, the PMN process has resulted in restrictive
action by EPA or the company has acted voluntarily in light of
EPA's concerns for health or environmental effects. The PMN
review and evaluation process necessarily requires that EPA's
responsibility to reduce risk be exercised in the context of
encouraging innovation, particularly to ensure that overly strict
conditions are not imposed on the marketing of safer substitutes
for existing chemicals. Under the New Chemicals Program, consent
orders that restrict chemical manufacture pending development of
test data may be negotiated with a company submitting a PMN.
Section 5 regulations also require a manufacturer to submit
a Notice of Commencement of Manufacture within 30 days of non-
exempt commercial manufacture after the PMN review period has
expired. At this point the chemical is added to the TSCA
chemical inventory.
EPA is also authorized under section 5(a) to regulate new
uses of a chemical pending an EPA review. Significant new use
rules (SNURs) require manufacturers or processors to submit a
notice to EPA prior to manufacturing or processing a chemical for
a significant new use. SNUR authority is an important means of
targeting uses that may involve significant exposures to toxic
chemicals.
Accomplishments During Fiscal 1989
New chemical actions. More than 1,000 valid PMNs were
*
received by EPA during fiscal 1989, increasing the total since
the enactment of TSCA to almost 12,600. (Compared to the 2,400
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valid PMNs received in fiscal 1988, a substantially lower number
of PMNs was received in fiscal 1989. This may be attributed to a
speedup in submissions prior to the October 1988 effective date
of a $2,500 user fee for PMN reporting.) Including exemption
applications, the number of chemical substance submissions to EPA
since the program began is more than 15,000. Voluntary testing
in response to EPA concerns occurred in 53 cases during 1989 and
the same number of PMNs were subject to new section 5(e) consent
orders. During the last year, EPA also received test data on
eight chemicals as a result of section 5(e) consent orders.
Details of new chemical actions through fiscal 1989 are given in
Appendix D.
Expedited new chemical consent orders. During fiscal 1989,
EPA continued to improve on its procedures to expedite
development of section 5(e) consent orders, which are negotiated
with a company when the agency determines that a new chemical may
present an unreasonable risk of injury to human health or the
environment or that a new chemical will be produced in
substantial quantities and may result in substantial human or
environmental exposure. EPA adopted new procedures for the
development of relatively routine section 5(e) orders, which
reduces negotiation of standard section 5(e) order language and
speeds order preparation and review both inside and outside the
agency. The expedited procedure differs from the previous
procedure in two ways: Instead of EPA sending a draft order to
the company for comment, EPA, at the outset, sends a "5(e) action
letter" and generic order intended to provide the company an
understanding of the terms of the proposed order, and EPA signs
the order before the company signs it.
Expedited new chemical follow-up rules. In the case of a
section 5(e) consent order that applies to the manufacturer of a
particular new chemical substance, a SNUR is promulgated under
section 5(a)(2) to extend the terms of the section 5(e) consent
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order to all future manufacturers and processors of that
substance. A company intending to manufacture or process a
substance for a "significant new use" as defined by a SNUR must
submit a notice to EPA, which, upon making the appropriate
findings, can issue another consent order and amend the SNUR for
that particular substance, if necessary.
EPA published its expedited follow-up rule, or "generic
SNUR," on July 27, 1989 [54 FR 31298]. This procedural rule
provides an expedited rule-making procedure and a codification of
standardized regulatory language. The generic SNUR will
simplify the preparation of individual SNURs for chemicals
subject to section 5(e) orders and for other selected new
chemicals that have completed premanufacture review. This rule
will significantly enhance EPA's ability to issue comprehensive
regulation of new chemical substances quickly and inexpensively.
Study of testing requirements under section 5(e) consent
orders. EPA conducted an internal study to measure how much
information is being received through testing requirements that
are triggered under consent orders with certain manufacturers.
By May 1989, 330 chemicals had been regulated by section 5(e)
consent orders. Of these, 66 include testing requirements that
are triggered at specified production volumes. In general, the
findings indicate that the companies have complied with the
testing requirements of production-triggered orders. Nearly 83
percent of the data required under these orders is expected to be
received by EPA in the near future.
Evaluation of exposure-release-based policies. In early
1988, the Office of Toxic Substances introduced a policy to
require basic toxicity testing for new chemicals based on high-
production volume and anticipated levels of human exposure and
environmental release. Since its implementation, the
exposure-based policy has proved to be a vital and significant
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complement to the traditional risk-based review of new chemicals.
A total of 180 PMNs have entered the exposure-based review
process. Of these, 142 cases have resulted in testing decisions
from the agency. To date, PMN submitters have agreed to test or
have signed TSCA section 5(e) consent orders for 85 of these
substances.
In fiscal 1989, 69 exposure-based reviews were conducted.
Fifty-three cases resulted in testing decisions by the agency.
Of the 47 TSCA section 5(e) consent orders issued for fiscal 1989
PMNs, 26 were exposure based in nature.
Policy on free-radical initiators. A clarification of
reporting requirements under section 5 for polymers manufactured
using free-radical initiators was published in the June 28, 1989,
Federal Register [54 FR 27174J. It is now required that
free-radical initiators be listed in the polymer description when
the manufacturing process uses initiators at the level greater
than two percent by weight. This policy applies only to polymers
not listed on the TSCA chemical inventory as of the effective
date of the FR notice. The policy clarification arose as a
result of a specific enforcement action.
Initiatives Affecting Future Program Success
Streamlining the New Chemicals Program. Growth of the New
Chemicals Program under section 5 has demanded changes to
optimize resources and productivity. The initiatives being
considered cover four major areas:
reducing administrative burdens and costs of running the
program,
improving hazard and monitoring data collection for new
chemicals,
reducing the overall number of notices submitted for EPA
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review by expanding the exemption categories, and
reducing the burden of preparing consent orders under
section 5(e).
Many of the initiatives can be implemented without revisions
to the PMN rule itself, while others may require ruleraaking.
Currently, several options to amend the rule are under
consideration.
EPA-industry dialogue on the New Chemicals Program. EPA has
increased its efforts to open a dialogue on regulatory strategies
for new chemical substances by holding periodic meetings and
workshops with chemical industry and trade associations in the
United States.
Acrylate testing agreement. In December 1987, EPA
representatives and the SAM Panel of the Chemical Manufacturers
Association began a series of meetings in an attempt to provide
additional information on the potential health effects of
acrylate compounds. Available data indicate that some acrylates
are carcinogenic in animals. However, questions have been raised
by both EPA and the SAM Panel regarding the adequacy and
appropriateness of a number of the carcinogenicity bioassays.
More than 450 acrylates are in the TSCA chemical inventory and a
large number of PMNs have been filed for new acrylate substances.
Both EPA and the SAM Panel have expressed a desire to know more
about the potential human carcinogenic effects of these
substances. Under an agreement reached in May 1989, the SAM
Panel committed to perform additional toxicity testing to improve
understanding of the nature of these effects and to assist in the
refinement of an appropriate strategy for managing potential
risks associated with acrylates.
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Risk management options for CFCs and halons. Chapter 4
discussed the Chemical Testing Program's initiative in reviewing
human and environmental hazard information for those chemicals
identified as major potential substitutes for CFCs and halons.
Because of the tentative nature of product development, the New
Chemicals Program is concerned with setting a level of regulation
(if any) during the years when data on CFC/halon substitutes are
being obtained and reviewed for potential health and
environmental effects. The New Chemicals Program must develop
risk management options in the absence of complete data on the
substitutes. Accordingly, the Office of Toxic Substances and the
Office of Air and Radiation Programs, in consultation with
environmental and trade representative organizations, are
developing options for the review and regulation of all CFC and
halon substitutes. Review of substitutes reported as PMN
chemicals will be made in light of EPA's overall approach to CFC
and halon substitutes.
Biotechnology reporting rule. Due to the potential for
novel health and environmental issues posed by microbial
products, there is a consequent need for toxicological data, risk
assessment techniques, and improvements in associated scientific
skills. To date, EPA has received a small number of PMNs for
field release organisms; however, the high rate of innovation of
this technology portends a major increase in field release PMNs
in the next few years.
Policy for a coordinated federal framework for regulation of
biotechnology was published in the Federal Register on June 26,
1986 [51 FR 23313]. Under this policy, microorganisms altered
through deliberate human intervention to contain genetic material
from dissimilar source organisms (intergenerics) are "new
chemicals" subject to PMN requirements under TSCA section 5, if
they are manufactured for TSCA purposes. TSCA purposes include
general commercial and environmental applications, such as metal
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leaching, pollutant degradation, and enhanced nitrogen fixation
in plants. EPA plans to develop rules to ensure that EPA will
receive for review:
notices for "new" microorganisms for commercial
purposes, including research and development
applications for environmental releases; and
notices for manufacturing, processing, importing,
distribution, use or disposal of microorganisms which
represent significant new uses or significantly
different exposures.
In addition, EPA will initiate rulemaking to exempt from
review microorganisms used in certain contained systems.
To aid development of these proposed rules, EPA solicited
public comment on key issues in a February 15, 1989, Federal
Register notice [54 FR 7027]. (A companion notice [54 FR 7026]
solicited comments on issues related to regulation of
microorganisms under the Federal Insecticide, Fungicide, and
Rodenticide Act.) Plans are to propose these rules during fiscal
1991 and promulgate a final rule in fiscal 1992.
Strategies for the 1990s
Goals. New chemicals should not pose any unreasonable risk
when introduced into commerce. EPA's goal is to encourage the
chemical industry to develop safe chemicals and to develop and
exercise the ability to identify potentially risky chemicals
before they are manufactured. Success in preventing unreasonable
risk from new chemicals is limited by the difficulty of
predicting risk in the absence of some or all data. An expanded
ability to predict risk is therefore a major subsidiary goal to
preventing unreasonable risk.
Another goal of the New Chemicals Program is to promote
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voluntary action as a substitute for regulatory action. Because
unreasonable risk determinations often require costly testing, a
manufacturer may agree to take the more economically expedient
step of reducing exposure as if a chemical presented an
unreasonable risk rather than perform the analysis and testing.
Means to achieve goals. The preferred approach to
preventing unreasonable risk of injury from toxic chemicals is to
prevent toxic pollution in the first place. This can be achieved
if the chemical industry incorporates a more vigorous
environmental ethic into their R&D programs. Such an effort
would involve more premanufacture testing, better techniques for
risk prediction and risk assessment, and a commitment to the
development and marketing of safer chemicals. The biotechnology
industry, in particular, has an opportunity to adopt this ethic
at an early stage in its development. An incentive for the
chemical industry is that EPA may place fewer last-minute
controls on products coming through the PMN review process if a
commitment to risk reduction is demonstrated in a PMN.
EPA will attempt to find additional incentives to encourage
the introduction of safer chemicals. The environmental benefit
is that new and safer products will begin to replace older, more
hazardous products now in the marketplace.
EPA will also seek to improve prediction of risk in the
absence of data through an expanded SAR capability. This effort,
involving extending SAR endpoints for other than cancer and
aquatic effects, will also require an expanded testing and
toxicological analysis program.
NEXT ... Chapter 6 discusses EPA's growing emphasis on making the
chemical data it collects more accessible to others involved in
analysis of environmental data and risk management.
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6. ROLE OF INFORMATION IN MANAGING TOXIC CHEMICAL RISK
Background
Section 8 of TSCA and section 313 of EPCRA provide EPA with
tools to use in gathering information to identify, evaluate, and
manage risk from toxic chemicals. Section 8 of TSCA authorizes
EPA to require reporting and recordkeeping on chemical substances
and mixtures. Section 313 of EPCRA requires that companies
report annual emissions of hazardous chemicals and that EPA
compile this data in a Toxics Release Inventory and make it
publicly available. (Additional information about toxic and
hazardous materials is available locally under other sections of
EPCRA, and taken together, provide a total picture of community
risk. EPCRA requires state governors to set up local emergency
planning committees to receive and make publicly available
information from facilities in their states. EPCRA requires
these facilities to report inventories of hazardous chemicals and
to provide notification of accidental releases of chemicals that
are defined as extremely hazardous.)
Requirement to maintain records. Section 8(a) of TSCA
authorizes EPA to require chemical manufacturers, importers, and
processors to maintain records and report certain information to
the agency. Under 8(a), the Preliminary Assessment Information
Rule (PAIR), originally published on June 22, 1982 [47 FR 26992],
manufacturers of listed chemicals are required to report general
production, use, and exposure information. These data are
especially important to the agency's review of designated
chemicals recommended by the Interagency Testing Committee for
priority testing.
EPA also promulgated the Comprehensive Assessment
Information Rule (CAIR) on December 22, 1988 [53 FR 51698], under
section 8(a), to coordinate information collection among federal
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agencies. Chemicals subject to CAIR are nominated by EPA or
other federal agencies. Data collected in 1986 pursuant to the
Inventory Update rule, another 8(a) rule, also support chemical
screening activities.
Requirement to publish the TSCA Chemical Inventory. Section
8(b) requires EPA to compile, maintain, and publish an inventory
of chemicals in commerce, called the TSCA Chemical Inventory.
Chemicals on the inventory are considered to be existing
chemicals. Chemicals that are not listed on the inventory are
considered to be new chemicals; these fall under section 5
requirements for submission of premanufacture notification and
review by EPA. Chemicals that pass the PMN review and go into
production are added to the inventory upon the agency's receipt
of a Notice of Commencement of Manufacture.
Requirement to maintain records on adverse reactions. Under
section 8(c), manufacturers and certain processors must maintain
records of alleged "significant adverse reactions" to chemicals.
This information must be submitted to EPA on request.
Requirement to submit unpublished studies. Section 8(d)
requires manufacturers, processors, and distributors of chemicals
to submit lists of unpublished health and safety studies on
chemicals, which are specified in amendments to a model rule.
Requirement of "substantial risk" notification. Section
8(e) requires EPA to be immediately notified when new information
reasonably supports the conclusion that a chemical substance
presents a "substantial risk" to health or the environment.
Historically, EPA also receives a large number of voluntary
submissions related to chemical toxicity and exposure.
EPCRA section 313 reporting requirements. Under section 313
of EPCRA, each facility covered by the reporting requirement must
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submit a report by July 1 of toxic chemical releases during the
previous calendar year. The first reports, covering calendar
year 1987, were due July 1, 1988. EPA developed a reporting form
with instructions and technical guidance on how to calculate
toxic releases from a facility. A company must submit reports to
EPA and to the states in which the host facilities are located.
EPA is required to make the data in the reports available to the
public through a TRI computer database. The database is intended
to help answer citizens' questions about chemical releases in
their community. The users of data are also likely to include
researchers from government or universities conducting health and
environmental analyses. EPA expects to use the data in a variety
of ways, including as a screening tool to develop priorities for
eliminating unreasonable toxic risk, reducing unnecessary
exposures, and preventing toxic pollution.
Accomplishments During Fiscal 1989
In fiscal 1989, the Office of Toxic Substances focused on
using information more effectively. Chemical data from a variety
of sources were successfully integrated into a comprehensive
database, and there was a significant increase in the number of
people who accessed and used the data to improve toxic chemical
risk management. The Office of Toxic Substances will continue to
improve information management in the 1990s.
Information received under TSCA section 8. In fiscal 1989,
EPA received and reviewed a substantial amount of information on
existing chemicals. Under section 8(a), 115 PAIR submissions and
640 CAIR submissions were received. More than 1,000 chemicals
were added to the TSCA Chemical Inventory. In response to
section 8(d) requirements, EPA received 1,565 submissions of
health and safety studies or toxicity data. In addition, EPA
received almost 290 initial and supplemental "substantial risk"
notifications under section 8(e). Another 164 voluntary
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notifications were also received for review. EPA made the health
and safety studies collected under section 8(d) publicly
available through the National Technical Information Service and
through an on-line public database.
Uses of TSCA section 8 information. The information
generated under section 8 authorities is essential to the EPA
risk assessment and risk management efforts. Section 8(d)
unpublished industry studies, for example, provide the agency
with safety, health, and environmental data which might otherwise
never come to light. Section 8(e) "substantial risk"
notification data provide an important input to EPA's risk
assessment activities, and are routinely shared with other
federal agencies. For example, EPA received animal
carcinogenicity data on refractory ceramic fibers from industry
under section 8(e). The agency is using the data to assess
substitutes for asbestos. EPA is also assessing epidemiological
data submitted by industry on o-toluidine and aniline, which
indicates increased cancer risk among workers are currently being
assessed. EPA has forwarded this data to other federal agencies,
including the National Institute of Occupational Safety and
Health (NIOSH) and the Occupational Safety and Health Agency
(OSHA). EPA is using animal retinopathy data submitted by
industry under 8(e) to assess potential risks posed by certain
aromatic ether diamines, and EPA has shared toxicologic and
exposure data with NIOSH, OSHA, and other agencies.
Chemical Hazard Information Profiles. During fiscal 1989,
EPA prepared Chemical Hazard Information Profiles (CHIPs) on five
chemicals. To prepare CHIP documents, EPA reviews a wide range
of literature and data sources, and solicits information from
companies, government agencies, and other institutions involved
in chemical risk assessment.
Since the end of fiscal 1989, CHIPS have been superseded by
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a new document—referred to as a "screening dossier"—whose
content and format have been designed to speed up the screening
of existing chemicals.
Substitute Hazard Profiles. These are preliminary risk
identification documents prepared to ensure that TSCA regulatory
actions will not encourage an equally or more hazardous chemical
or use to be substituted for the chemical or use being considered
for regulation. Last year, Substitute Hazard Profiles were
prepared for lead and cadmium covering uses in 11 product
categories. Appendix E provides details about these submissions
and actions in fiscal 1989.
TSCATS. Another major activity contributing to increased
integration of and access to chemical information was the TSCA
Test Submissions (TSCATS) database, which is a "pointer" file on
difficult-to-acguire, unpublished chemical test information.
TSCATS indexes chemical test submissions and health and safety
data required under TSCA sections 4, 8(d), and 8(e) and includes
voluntary FYI submissions. The database contains more than
11,000 documents describing 47,800 test studies on 3,550 unique
chemicals. Access to TSCATS and the studies it captures is
provided in several formats, including magnetic tape, direct
on-line, microfiche copies, and Compact Disk Read-only Memory
(CD-ROM). Among the users of the database are federal and state
agencies, researchers, risk assessors and managers, chemical
industry, trade and professional associations, and health and
environmental professionals.
In addition to TSCATS, approximately 50 other toxic
chemical-related databases are maintained by the Office of
Pesticides and Toxic Substances.
Compilation and publication of Toxics Release Inventory m
another significant event in fiscal 1989, EPA successfully met
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the EPCRA section 313 requirement to compile the TRI and make it
available on-line through the National Library of Medicine's
TOXNET system. Anyone with access to a personal computer, modem,
and communications software can use the TRI, for a small fee, to
obtain toxic emissions data by geographic area, facility,
chemical released, or any other search criteria. Use of the
database has already been heavy, constituting 43 percent of total
TOXNET usage with 69,000 searches and 2,500 connect hours in just
3 1/2 months.
To create the database for the National Library of Medicine,
EPA first developed an internal database on the agency's
mainframe computer and entered into it more than 74,000 reports
submitted by about 19,000 facilities for 1987. Following
extensive data quality checks, the data were uploaded into the
library's system. It became available to the public on June 19,
1989. To enable citizens to capture TRI data in a suitable
format, EPA developed software that converts the TRI data into
dBase format and allows the generation of a wide variety of
reports. This software is being distributed on PC diskette free
of charge.
In addition to the public database, EPA also made the TRI
information available through a variety of electronic and
non-electronic means. EPA published a national report, "The
Toxics Release Inventory: A National Perspective," which
describes the database and presents extensive summary information
in texts, charts, and graphics. Magnetic tapes of the entire
database and PC diskettes of data for individual states were
distributed to requesting states and made available for purchase
through the Government Printing Office and the National Technical
Information Service. Microfiche versions of the database, or
3 EPA 560/4-89-005, Pesticides and Toxic Substances
(TS-779), June 1989
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portions thereof, were distributed at the beginning of 1990 to
more than 1,400 federal depository libraries and public libraries
in almost 2,400 counties across the country. EPA made
significant progress towards the development of a CD-ROM version
of the database, to be made available in fiscal 1990. Citizens
can also contact the TRI Reporting Center for copies of
individual forms submitted by facilities.
Promoting use of TRI data. During fiscal 1989, a great deal
of effort was put into facilitating and promoting use of TRI
data. Numerous courses were conducted to train state personnel
and EPA staff on using both the internal EPA data system and the
publicly available NLM system. Within the agency, a data use
subgroup was formed to promote the use of TRI data by EPA
regional and program offices, and a computer bulletin board was
established to describe and track analyses performed by those
offices. A number of EPA regional offices produced summary
reports for their regions or compiled TRI data for individual
states or metropolitan areas. Regional TRI staff also worked
actively with EPA regional media personnel to urge use of TRI
data for cross-checking permit data and other applications.
EPA also developed and published the "Toxic Chemical Release
Inventory Risk Screening Guide, Version 1.0" (EPA 560/2-89-002,
July 1989) to assist state and local decisonmakers in using TRI
data to develop priorities for investigating facilities,
chemicals, and exposed populations. Two training sessions in use
of the guide, risk communication, and use of the NLM database
were held for state and local officials in McLean, Virginia, and
Denver, Colorado.
Financial assistance to TRI users. Because one of the
potential impediments to use of TRI data is the cost of buying
the necessary equipment and paying the National Library of
Medicine's hourly charge, EPA initiated a pilot effort to provide
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limited financial assistance to states, localities, and certain
public interest groups. EPA received 21 requests for fee waivers
to use the TRI database and approved 17 of these. The average
fee waiver granted under the pilot project was $1,400. At least
one project was approved in each EPA region except for Region 7,
where no applications were received. Recipients were local or
county governments or local emergency planning committees. One
state university and a couple of environmental groups were also
approved.
In all but one case, the fee waiver recipients did not use
their waiver or used only a small portion of it. The most
frequently cited reasons for this were:
1. People are interested in the TRI data, but they do not
have the time to work with it or are not sure how to put
the data to use.
2. The TRI system was found to be difficult to access or
use.
The Office of Toxic Substances interviewed the contacts for
the 17 pilot projects to determine their experiences with trying
to use TRI. The information obtained has been useful in helping
to target resources and in identifying outreach techniques that
some participants tried. Ultimately, a decision was made not to
offer fee waivers but instead to operate a TRI user assistance
service, called TRI-US, during a trial period to determine what
kinds of information or assistance is needed by TRI users. The
service has been heavily used. In the near future, the Office of
Toxic Substances will evaluate this project to determine whether
it should be continued or how it should be revised.
Other financial assistance was provided to four states,
which received about $45,000 each through a cooperative agreement
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with the National Governors Association for TRI data management,
use, and quality assurance projects. Also, New York State
received a grant of $64,000 under TSCA section 10 to integrate
TRI data into a geographic information system.
TRI outreach program. As in previous years, EPA conducted
extensive industry outreach campaigns to increase awareness of
and compliance with section 313 requirements. EPA regional
offices were key to this effort, conducting 97 industry workshops
and seminars with more than 8,000 attendees and providing a wide
range of other technical assistance.
A new development in the industry outreach program was the
production of a comprehensive reporting package, which included
all the major documents needed to report chemical releases or
emissions. The reporting package was mailed to all facilities
that filed 1987 reports to assist them in completing their
reports for 1988. EPA also developed and distributed a brochure
to assist industries in complying with the new supplier
notification requirements. Other events of the 1989 outreach
program were a national EPCRA Trade Association meeting and a
"Train the Trainers" course designed to teach state personnel,
industry representatives, consultants, EPA regional staff, and
others how to train people in complying with section 313
requirements and completing the reporting form. Also, EPA
expanded the hours of operation of the EPCRA telephone assistance
hotline and increased the number of specialists available to
answer technical questions.
TRI petition process. Section 313 allows EPA to modify the
list of chemicals covered by the law and establishes a petition
process to allow anyone to request removal or addition of
chemicals to the list. EPA received 49 petitions as of May 1990,
11 of which were received in fiscal 1989. Also in 1989, EPA
granted petitions to delist three chemicals, proposed to grant
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delisting to four additional chemicals, and denied petitions to
delist three chemicals. EPA also published a proposal to add 10
chemicals to the TRI list for reasons of carcinogenicity and
human chronic toxicity.
Initiatives Affecting Future Program Success
PC Conference. In October 1989, the Office of Toxic
Substances and the Office of Information Resources Management
co-sponsored the First Conference on Public Access to
Environmental Data. The purpose was to initiate a dialogue with
groups inside and outside the agency on public access and to
stimulate interest in using personal computers for the analysis
of environmental data and risk management. The audience included
representatives from environmental/public interest groups,
industry, academia, librarians, journalists, congressional staff,
and other federal, state, and local agencies, as well as EPA
staff. EPA expects to hold a second conference in the future to
maintain momentum in increasing integration of and access to
chemical data.
TSCATS enhancement. To make TSCATS more useful in managing
chemical risks, EPA is examining the feasibility of entering and
indexing submissions more quickly and of adding to the database
abstracts summarizing test results.
Access to TSCA Chemical Inventory. In fiscal 1989, EPA
began reorganizing the inventory for greater access. The
inventory contains production data, which are updated every four
years, on chemical substances of greatest concern. Development
has begun on a format to make non-confidential production data
available to general users.
Use and utility of TRI data. The following efforts are
under way to improve the outreach and compliance efforts and
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refine the section 313 reporting rule:
EPA supported development of a publication to help
environmental journalists interpret and report on toxic
chemicals and the TRI data. The guide, Chemicals. the
Press, and the Public; A Journalists7 Guide to Reporting
on Chemicals in the Community, was published in the fall
of 1989.
Information from a major compliance survey and detailed
telephone and site audits will be used to better target
enforcement and outreach efforts.
A screening process and criteria are being developed to
evaluate chemicals for possible addition to or deletion
from the section 313 list. Industrial classifications
outside the manufacturing sector are being examined to
determine if any should be added to the regulation's
coverage.
EPA is examining the feasibility of requiring reporting
of "peak release" data, including the largest volume of
release over an eight- or 24-hour period, as well as
total days of release for the facility.
Development of an assistance program to provide grants
and cooperative agreements to states under TSCA section
28 for projects that will improve the quality of the TRI
data. In fiscal year 1989, EPA awarded $1 million in
grants to 11 states for TRI data quality assurance
projects. The grants were provided to build at the
state level the capacity to evaluate the quality of
facility submissions in order to assure the quality of
the database created from them. Improving the quality
of the database will increase the utility of the TRI
data for state programs in identifying, communicating,
preventing, and controlling toxic chemical risks. The
following states received funds: Ohio, Minnesota,
Kansas, Colorado, California, North Carolina,
Connecticut, Kentucky, Louisiana, Maryland, and
Missouri. The grants ranged from a low of $24,285
(Kansas) to a high of $131,550 (North Carolina).
On March 8, 1991, EPA published a Federal Register
notice announcing the availability of $800,000 in TRI
grant funds to establish programs of TRI data
management, analysis, use, and quality assurance to
assist states in preventing or eliminating toxic
chemical risks. The expanded purpose of the grant
program is reflected in its title—the TRI Data
Capabilities Program, as opposed to the earlier TRI Data
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Quality Assurance Program. The deadline for
applications for fiscal year 1991 funding is June 6,
1991.
The fiscal year 1992 budget requests $1 million for TRI
state grants.
Strategies for the 1990s
Goals. EPA intends to expand significantly the use of
information as a risk reduction tool. The TRI database has
already had a great influence in intensifying the chemical
industry's concerns about the local and national health and
environmental risks which may be posed by their products. TRI
has also increased cooperative efforts among EPA, the states, and
the public as more interest in toxic risk management has
developed at the local level. Data and their interpretation are
the principal requirements for sharing the opportunities of risk
management among the larger toxics community.
Means to achieve goals. EPA will seek to integrate data on
toxic substances across program lines and to support multi-media,
multi-chemical, multi-facility risk assessments, regulation, and
enforcement. EPA will also encourage the development of state
programs to collect and report information helpful to the agency
in identifying chemicals for product bans or restricted use
actions.
NEXT ... Chapter 7 discusses EPA's accomplishments in risk
assessment and risk management in fiscal 1989 and its goals and
strategies for implementing major improvements in the Existing
and New Chemicals Programs in the 1990s.
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7. ASSESSING AND MANAGING TOXIC CHEMICAL RISK
Background
Risk assessments are essential to the risk management
process. They allow the evaluation of how alternative regulatory
and non-regulatory actions would reduce risk. They also support
the decision to initiate or not initiate the risk management
process for chemicals that have passed through an initial
screening.
The major risk management activities in the Office of Toxic
Substances during fiscal 1989 centered on PCBs and asbestos.
PCBs and asbestos in schools share the distinction of having been
singled out by Congress for control: PCBs under TSCA section
6(e) and asbestos under AHERA. A further common element is that
state and local governments have joined EPA regional offices as
partners in control efforts.
The Office of Toxic Substances also supported actions during
the year to reduce risks from lead and to prohibit the use of
hexavalent chromium in comfort cooling towers.
Accomplishments in Risk Assessment in Fiscal 1989
Ongoing and completed risk assessments. In fiscal 1989,
assessments of the risk to health were ongoing or completed for
the following:
Use of lead solder in potable water plumbing in support
of the Office of Drinking Water
Asbestos substitutes (in support of the Asbestos Ban and
Phase-out Rule issued under TSCA section 6)
Updating the risk assessment for inhalation exposure to
formaldehyde
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Disposal of lead batteries in municipal solid waste in
support of the Office of Solid Waste*
Chlorofluorocarbons/halons risk management support. In
fiscal 1989, a cross-program effort in EPA supported risk
assessments of CFCs and halon substitutes. This joint program—
the CFC Substitutes Human Health and Environmental Effects
Program—ensures all relevant factors are considered in decisions
concerning the acceptability of CFC and halon substitutes. The
Office of Air and Radiation has the primary responsibility in EPA
for activities related to the 1987 Montreal Protocol on
Substitutes that Deplete the Ozone Layer. The Office of Toxic
Substances carries the responsibility for reviewing the human and
environmental hazard and exposure information for chemicals
identified as major potential substitutes for CFCs and halons.
Pre-risk management risk assessment projects. Ongoing
pre-risk management risk assessment projects include:
Assessment of the hazards of a large group of
potentially hazardous compounds used as "inert"
ingredients in pesticide formulations. This project is
being performed in cooperation with the pesticides
program.
Development of a risk assessment strategy and a work
plan in anticipation of the receipt of the results of
testing of twelve chemicals for the presence of PCDDs
and PCDFs and their brominated analogs. This testing
was required by EPA in a 1987 test rule [52 FR 21412].
Positive results will trigger initiation of a risk
assessment with a one-year completion date.
This health risk assessment was not completed, and there is
no intention of issuing a final study. Issues related to
management of lead are now being handled via the agency's
overall lead strategy, which includes an ongoing negotiated
rulemaking.
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PCDDs/PCDFs risk assessment. A major multi-media
assessment of risks to humans and the environment from exposure
to PCDDs and PCDFs that are inadvertently formed during pulp
paper bleaching operations was undertaken in fiscal 1989. The
toxic substances program solicited and has received the active
participation of the Offices of Water, Air and Radiation, and
Solid Waste, as well as the Food and Drug Administration (FDA),
Consumer Product Safety Commission (CPSC), and NIOSH. EPA
completed the risk assessment and announced its decision on the
need for additional regulation on April 30, 1990, in accordance
with the terms of a consent decree developed between EPA, the
Environmental Defense Fund, and the National Wildlife Federation.
Accomplishments in Asbestos Risk Management in Fiscal 1989
EPA has taken a series of actions since 1971 to reduce or
eliminate exposures to asbestos. Asbestos was first regulated by
EPA under the Clean Air Act as a hazardous air pollutant, and
more recently under TSCA and AHERA. Also, EPA is one of several
agencies, including OSHA and CPSC, which together provide
regulatory programs spanning a broad spectrum of occupational and
non-occupational exposures to asbestos.
Asbestos Ban and Phase-out Rule. On July 12, 1989, EPA
published a final rule [54 FR 29460] under section 6 of TSCA to
ban the manufacturing, importing, and processing of most asbestos
products in three stages, beginning with certain products on
August 27, 1990, and with others on August 25, 1993, and August
26, 1996. Table 7-1 lists the products affected and the stages
into which they fall. Corresponding bans on the distribution of
asbestos products will occur in 1992, 1994, and 1997. The stage
at which each asbestos product is banned is based on the
projected availability of a safe substitute for that product.
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The rule provides that exemptions from the ban may be
granted only if specific criteria for submitting exemptions are
met. To obtain an exemption, an applicant must show that the use
described in the application would not pose an unreasonable risk
to human health and must demonstrate evidence of good faith
efforts to develop substitutes for the use described in the
application. EPA imposed this ban because, despite public and
private sector actions to reduce harmful asbestos emissions in
the workplace, significant levels of asbestos fibers continue to
be released during the production, use, and disposal of asbestos
products. The agency concluded that the possibility of ongoing
fiber releases from these products pose an unreasonable health
risk since safer asbestos-free substitutes are or soon will be
available.
Unlike other asbestos regulations, which are limited to
remedial actions, this rule prevents future risks to human health
by eliminating or greatly reducing the products that have the
potential for releasing asbestos fibers.
Asbestos in schools. In fiscal 1989, EPA continued its
efforts to ensure compliance with AHERA, which established a
comprehensive program for addressing asbestos problems in the
nation's public and private schools. In October 1989, the agency
announced that 94 percent of the school districts and private
schools had inspected their school buildings for asbestos and
developed asbestos management plans as required by AHERA. EPA is
taking action, including civil penalties, to bring the remaining
schools into compliance (See chapter 8).
In addition to its enforcement efforts, the agency has also
helped schools select and carry out the most appropriate asbestos
control options by ensuring an adequate supply of trained,
accredited asbestos professionals and by offering guidance on
asbestos to school officials and parents. By the end of fiscal
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1989, EPA had approved more than 1,300 accreditation training
courses and 15 state accreditation programs in its efforts to
establish an adequate infrastructure of qualified personnel.
In June 1989, EPA, in conjunction with the National
Education Association and the National Parent Teacher
Association, published the booklet The ABC's of Asbestos in
Schools. The publication helps parents and teachers learn about
asbestos in schools and outlines the responsibilities of school
officials to protect school children and employees from possible
asbestos exposure. EPA has also published a wide range of
documents to assist individuals in successfully carrying out the
more technical aspects of the AHERA regulation.
Under the ASHAA, EPA awarded $45 million in loans and grants
in fiscal 1989 to help the most financially needy public and
private non-profit primary and secondary schools abate asbestos
hazards. Since the first ASHAA awards were issued in 1985, EPA
has provided $201.8 million for nearly 2,200 school asbestos
abatement projects. Based on the abatement projects supported,
these awards should reduce the weekly exposure of schoolchildren
and employees to asbestos by 17.3 million hours. Details of the
loan and grant program awards since 1985 are given in Appendix F.
In fiscal 89, the Office of Toxic Substances continued to
work with the National Institute of Standards and Technology
(NIST) to develop a laboratory accreditation program for
laboratories which analyze bulk asbestos materials by polarized
light microscopy (PLM). In fiscal '88, in an effort to provide a
source of accredited laboratories for local education agencies,
the Office of Toxic Substances issued "interim accreditations" to
PLM laboratories which had successfully participated in EPA's
round-robin testing program. This effort was continued into
fiscal '89 until the NIST program became operational. In
September 1989, NIST had accredited 500 PLM laboratories. The
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Table 7-1. Status of Asbestos Products Under
the Ban and Phase-out Rule*
The stage at which each product is banned is based on the projected
availability of a safe substitute for that product.
First stage Ban; 8/27/90
Felt Products
Pipeline wrap
Roofing felt
Flooring felt
Asbestos cement (A/C) Products
A/C sheet, corrugated
A/C sheet, flat
Products out of use
Vinyl asbestos floor tile
Asbestos clothing
Second stage Ban: 8/25/93
Friction Products**
Drum brake linings (OEM)
Disc brake pads, LMV (OEM)
Disc brake pads, HV (OEM)
Clutch facings
Automatic transmission components
Industrial and commercial friction
products
Gaskets
Beater-add gaskets (except some
industrial uses)
Sheet gaskets (except some
industrial uses)
OEM - original equipment market
AM - after market
LMV - light and medium vehicles
HV - heavy vehicles
Third Stage Ban; 8/26/97
Coatings
Roof coatings
Non-roof coatings
Paper Products
Commercial paper
Rollboard
Millboard
Corrugated paper
Specialty paper
Friction Products
Brake blocks (OEM)
Brake blocks (AM)
Drum brake linings (AM)
Disc brake pads, LMV (AM)
Disc brake pads, HV (AM)
A/C Products
A/C pipe
A/C shingle
Not banned
Missile liners
Asbestos diaphragms
Battery separators
Arc chutes
Acetylene cylinder filler
Textile products (except
clothing)
Asbestos reinforced
plastic
Sealant tape
High-grade electrical
paper
Asbestos packings
Some industrial use of
sheet gaskets
Some industrial
uses of beater-add
gaskets
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* Federal Register No. 132, July 12, 1989, p. 29460 [54 FR 29460]
** For OEM motor vehicle brakes, ban is effective next model year
after second stage ban.
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Office of Toxic Substances and NIST also continued to coordinate
the construction of a laboratory accreditation program for
laboratories analyzing air samples for asbestos by transmission
electron microscopy.
Asbestos in public and commercial buildings. This is
another area in which EPA accelerated its efforts in fiscal 1989.
In addition to approval of the AHERA training courses and state
accreditation programs noted above, EPA provided financial and
technical assistance to states and public and private
organizations to help them enhance their asbestos control,
management, and accreditation programs. The agency views these
efforts as vital to ensure an adequate infrastructure of
well-trained asbestos professional available for work in the
country's more than 3.6 million public and commercial buildings.
Initiatives Affecting Future Asbestos Program Success
In its 1988 Report to Congress, EPA Study of
Asbestos-Containing Materials in Public Buildings, EPA stressed
that the lack of basic information about asbestos exposure and
the efficacy of various management and abatement strategies
"limits the agency's present ability to assess options, draw
conclusions, and make recommendations concerning the regulation
of asbestos in public and commercial buildings." With this in
mind, EPA began the following information gathering initiatives
in fiscal 1989. These initiatives are helping the agency better
evaluate the impact of regulating asbestos in public and
commercial buildings:
AHERA rule evaluation. EPA began a major evaluation of the
AHERA rule to assess its implementation in schools and to help
determine the need for additional regulation in non-school
buildings.
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EPA asbestos research. EPA continued and completed several
research projects on the effectiveness of various asbestos
management and abatement techniques. This includes a study by
the Office of Research and Development on the effectiveness of
air filtration equipment and methods of carpet cleaning. The
Office of Research and Development also made progress in
developing an analytical method for measuring asbestos in floor
tile. These R&D activities will improve the scientific and
technical basis for shifting the management of asbestos to a more
risk-based approach.
EPA has also undertaken activities to improve risk
estimation to aid asbestos risk management decisionmaking. For
example, a technical paper has been submitted to a scientific
journal on the use of electron microscopy measurements.
Health Effects Institute project. EPA sponsored a major
public-private research project under the direction of the Health
Effects Institute, an environmental research organization based
in Cambridge, Massachusetts. This research was initiated by a $2
million congressional appropriation and $2 million in matching
private funds and it represents EPA's principal research effort
to learn more about asbestos exposures in buildings. About $12
million is targeted for this effort. The uses of the research
results is discussed below under Asbestos Program Strategies for
the 1990s.
Policy dialogue. EPA began a policy dialogue with all the
groups affected by the problems posed by asbestos in buildings to
help the agency determine the most appropriate programmatic and,
if necessary, regulatory response to those problems.
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Asbestos Program Strategies for the 1990s
Goals. Of the risks associated with friable asbestos in
schools, the risks to maintenance, service, and abatement workers
are the greatest. Ensuring that workers receive the precautions
already required by EPA and OSHA is a paramount goal related to
eliminating unreasonable risk. A continued programmatic emphasis
on basic training and accreditation and vigorous compliance
efforts remain as critical strategic elements into the future.
These same elements are the primary means of also reducing
unnecessary exposure to asbestos.
A further goal is to strengthen the EPA-state partnership by
increasing the number of states with accreditation programs
consistent with AHERA, the number of states which will assume
responsibility for implementing the asbestos-in-schools program,
and the number of states with accreditation programs for asbestos
workers dealing with public and commercial buildings.
Means of achieving goals. Research data from the Health
Effects Institute project is expected to provide information on
the relative contribution of episodic exposures and total
exposures to asbestos in buildings. Also, new information will
be developed regarding both the efficacy of removal as an
abatement technology and the long-term effectiveness of managing
asbestos in place through operation and maintenance protocols.
The EPA policy dialogue and the ongoing evaluation of AHERA, in
conjunction with the Health Effects Institute's research results,
is expected to afford some analytical basis for considering which
elements, if any, are necessary to address the broader problem of
asbestos in public and commercial buildings.
Providing opportunities and incentives for voluntary
participation is key to enhancing the state and public sector
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roles. Where states have independent authority and are
interested in assuming responsibility for particular portions of
the program, EPA will recognize, defer to, and support to the
extent possible their initiatives. This will produce a mutually
advantageous working arrangement in which EPA will be able to
leverage its resources on the basis of the state's activities.
Private sector incentives will remain predominately driven
by considerations of tort liability and the cost of asbestos
abatement. However, they will also be positively influenced by
agency technical assistance and by well-conceived and forcefully
executed enforcement policies. Coordinated EPA enforcement
activities, coupled with increased training and technical
assistance, will be aimed at directing private-sector initiative
and involvement in public health directions.
Initiatives Affecting Future PCS Program Success
Historically, the PCB program has concentrated its efforts
on phasing out new product use of PCBs and on managing the
estimated 750 million pounds of PCBs which remained in use as of
1976, when TSCA was enacted. Priority has been given to the safe
management of high-volume/high-concentration PCB electrical
equipment for the remainder of its useful life and to its safe
disposal. This is reflected in the recently promulgated
Notification and Manifest Rule (see below), which is a major
regulation concerning PCB storage, transportation, and disposal.
By the mid-1990s EPA expects that a significant amount of
PCB-containing equipment will have been retired from service and
the PCBs safely disposed of. While regulating this process, EPA
is also turning its attention to another tier of widespread PCB
problems, which can be characterized as high volume/low
concentration PCB problems. The principal accomplishments in
fiscal 1989 concern initiatives aimed at raising the priorities *
of this group of PCB problems.
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Notification and Manifest Rule. EPA promulgated the
Notification and Manifest Rule on December 21, 1989 [54 FR
32716]. This rule affects several thousand generators and
storers of PCBs by imposing a tracking system for PCB waste. The
principal problems this rule addresses are the improper storage
of PCB wastes by commercial storers and the abandonment of such
wastes when companies go out of business. The rule requires (1)
generators, storers, disposers, and transporters of PCB waste to
notify EPA of their activities, (2) manifesting of PCB waste from
generation to disposal, and (3) commercial storers of PCB wastes
to apply for approval of their commercial storage facilities,
provide a closure plan, provide financial assurance, and be
subject to a background check of the business and of key
personnel for criminal violations of environmental laws.
Exemptions. Another rule, proposed in August 1988 [53 FR
32326], which addresses 12 individual and class petitions for
exemption from prohibition against the manufacture, processing,
and distribution of PCBs in commerce was promulgated on May 22,
1990.
Non-metallic debris. This is one of the high-volume/
low-concentration problems EPA is continuing to investigate.
PCBs are sometimes found in non-metallic debris ("fluff") that
results when autos and major household appliances are shredded to
recover metals. Fluff has been found to contain PCBs at
regulated concentrations (above 50 parts per million) and is
disposed of in municipal landfills. It also contains other
hazardous materials, such as lead and cadmium.
Superfund site cleanup. EPA has found that 17 percent of
Superfund cleanup sites contain PCBs. This fact has prompted the
agency to develop cross-program work groups to address the
problems of site remediation under both the requirements of TSCA
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and the Comprehensive Environmental Response Compensation and
Liability Act of 1980 (CERCLA).
PCB contamination in natural eras pipelines. Since 1981 EPA
has monitored 13 interstate natural gas pipeline companies due to
the PCB contamination in their systems. EPA believes most of the
contamination was caused by PCB lubricants used in natural gas
pipelines being released into the pipeline itself. The PCBs are
mobile within the systems, usually combining with natural gas
condensate composed of water and constituents of natural gas.
The mobility of the PCBs in the system makes their regulation and
control problematic.
In recent years, EPA has sought enforcement actions against
pipeline companies for improper disposal of PCB condensate in
pits, ponds, and lagoons which may contaminate groundwater.
Currently, EPA is operating under a Memorandum of Understanding
(MOU) with the Federal Energy Regulatory Commission (FERC) which
requires EPA to approve all proposals to abandon in place or
remove segments of the pipeline system submitted to FERC. In
addition to pipeline removal and abandonment projects, EPA has
been regulating PCB contamination at air compressor stations in
interstate natural pipeline systems.
Although PCB contamination in natural gas pipelines is
primarily managed through TSCA, in some circumstances it is also
managed through other federal and state laws. In fiscal 1989,
EPA continued to meet with interstate pipeline companies to
consider various abandonment and removal proposals. In fiscal
1990, EPA has begun development of technical guidance to the
pipeline industry to expedite the approval of
abandonment-in-place projects.
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PCB Strategy for the 1990s
While managing "traditional" PCB concerns, EPA will also
give higher priority to the more difficult management problems
associated with high-volume/low-concentration problems, such as
those described above.
Goals. Because PCB contamination is ubiquitous and the
potential management resource requirements can be large, program
emphasis must be placed on risk-based priorities. Consequently,
EPA intends to: (1) develop and apply a strong risk-based
approach to managing PCB contamination, (2) ensure prompt and
adequate disposal of PCBs no longer in service, and (3) focus
enforcement actions on cases and violators representing the
greatest potential threat to health and the environment.
Means to achieve goals. EPA intends to implement a more
diversified management approach involving federal, state, and
local governments. A broader role will be developed for states
and localities in disposal and management of cleanup operations.
Also, full compliance of federal facilities with applicable
requirements will be vigorously pursued.
Diversification also requires EPA to look for opportunities
to link PCB management under TSCA with waste management and
decontamination programs elsewhere in the agency and in the
states. Examination of the adequacy of existing PCB regulations
under TSCA to support an integrated waste management program is a
high priority. Also, current joint research of EPA's Office of
Pesticides and Toxic Substances and Office of Research and
Development will be expanded to provide new risk assessment and
risk management tools needed to address management of
low-concentration PCB problems.
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Lead — Risk Management Support Activities in Fiscal 1989
Lead in municipal waste. In support of the Office of Solid
Waste, the Office of Toxic Substances conducted an analysis of
lead- and cadmium-containing products which enter municipal
waste, and preliminarily identified those for which viable and
less hazardous substitutes might exist. The report, "Uses and
Substitutes Analysis for Lead and Cadmium Products in Municipal
Solid Waste," was delivered to OSW in September 1989.
An additional task undertaken for OSW was to determine the
feasibility and desirability of employing TSCA section 6(a) to
divert lead acid storage batteries and other lead-containing
products from the municipal waste stream to secondary smelters
for recycling. The report, "Factors Bearing on Use of TSCA to
Reduce Introduction of Lead into Municipal Waste and the
Environment," was completed in November 1989. The report will
provide the basis for a regulatory investigation under TSCA
section 6(a).
Lead pollution prevention program. This is a cross-program
effort within EPA, under the leadership of the Office of Toxic
Substances, to undertake several initiatives to reduce human
exposure to lead. Within the Office of Toxic Substances, the
effort will explore the feasibility of using TSCA section 6(a)
to: (1) reduce the overall consumption of lead, (2) encourage
recycling of lead-containing products and the use of substitutes
for lead, and (3) restrict or ban uses of lead associated with
high exposure. An evaluation of economic incentives to achieve
these ends is part of the program.
Lead in paint. The Lead Paint Poisoning Prevention Act of
1971 placed the responsibility for lead-based paint hazard
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mitigation and research entirely with HUD. The 1989 EPA and HUD
Appropriations Conference Report directed the two agencies to
develop a Memorandum of Understanding stipulating, among other
things, the support that EPA would provide to HUD in satisfying
several requirements mandated in the Housing and Community
Development Act of 1987. In the Memorandum of Understanding,
dated April 1989, EPA also agreed to join with HUD in recruiting
and chairing an interagency task force established for lead-based
paint program development.
The reguirements are that HUD report to Congress on the
findings and recommendations of a demonstration of abatement
techniques in HUD-owned single- and multi-family housing, conduct
a national survey of the extent of the lead-based paint hazard in
housing in the United States, and submit a "comprehensive and
workable plan" by September 1990 for addressing the lead-based
paint problem. EPA is providing technical assistance in two
major areas: (1) development of information needed to complete
the demonstration, survey, and plan, and (2) training of HUD and
public housing personnel in program administration and training
of contractor and designer personnel in safe and effective work
practices.
Other Risk Management Activities in Fiscal 1989
On June 10, 1985, EPA published a Notice of Intent to list
chromium or hexavalent chromium as a hazardous air pollutant
under Section 112 of the Clean Air Act. The notice presented
estimates of emissions from 11 sources, including comfort cooling
towers, which are an integral part of heating, ventilation, and
air conditioning or refrigeration systems. Hexavalent chromium
has been determined to be a potent human carcinogen.
On March 2, 1988, EPA issued a proposed prohibition on use
of hexavalent chromium in comfort cooling towers under authority
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of TSCA section 6. During fiscal 1989, EPA prepared the final
action prohibiting the use of hexavalent chromium in comfort
cooling towers. The prohibition was issued on January 3, 1990
[55 FR 222], with an effective date of May 18, 1990.
Risk Management Strategy for Existing Chemicals
The Office of Toxic Substances is redirecting its efforts in
the Existing Chemicals Program to use TSCA more effectively. The
following changes are taking place.
Chemical screening. To support making decisions on risk
reduction, chemical screening will be linked more directly to
risk management. The Office of Toxic Substances will begin
screening clusters, or like groups, of chemicals together.
Screening activities will also build on growing international
efforts where EPA is already in a principal role, such as in the
Organization for Economic Cooperation and Development (OECD). In
the meantime, EPA has begun selecting chemical clusters for
screening and expects to provide screening results in the fall of
1990.
Chemical testing. Wherever possible, the Office of Toxic
Substances will use model, or generic rules, to maximize
productivity. The Office of Toxic Substances will also initiate
a program to identify chemical testing priorities. This program
will define the universe of data needs for TSCA chemicals,
provide for government and public participation to determine
national testing priorities, and focus the testing effort on the
highest priority data needs.
Risk management. Opportunities for risk management will be
considered at all stages of the risk assessment process to allow
earlier actions to be taken when appropriate. In addition, the
process will use a graduated response to risk reduction,
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employing a step-wise review and a delegation of all but
regulatory decisionmaking to lower levels in the Office of Toxic
Substances to expedite action. The menu of regulatory actions
will also include concepts such as "product stewardship," where a
manufacturer assesses the safety, health, and environmental
information on its products throughout their lifecycle and takes
appropriate steps to protect employee and public health and the
environment. In addition, the process will include associated
technical assistance activities similar to those used in EPA's
asbestos-in-schools program: citizen and consumer guides,
technical control guidance and worker instructional pamphlets,
training materials, and dialogues on key issues.
NEXT ... Chapter 8 discusses compliance and enforcement program
activities and civil enforcement actions undertaken in fiscal
1989.
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8. COMPLIANCE AND ENFORCEMENT
Background
EPA has developed specific strategies to enforce regulations
under TSCA. These strategies identify and rank possible
violations, identify the available tools for compliance
monitoring, specify how these tools are to be used, and provide a
formula to determine the application of inspection resources.
Where inspectors uncover violations of TSCA requirements, EPA
levies civil penalties, as authorized by TSCA section 16.
Program Development Activities During Fiscal 1989
During fiscal 1989, EPA developed and issued compliance
monitoring strategies for AHERA and the Asbestos Abatement
Projects Worker Protection Final Rule. EPA also developed an
interim final enforcement response policy for AHERA.
EPA continued cooperative enforcement programs to monitor
compliance with the PCB regulations in California, Connecticut,
Iowa, Kansas, Maryland, Michigan, Missouri, New Hampshire, New
Mexico, North Dakota, Ohio, Puerto Rico, Texas, and Washington.
Kentucky and Minnesota also entered into PCB cooperative
enforcement agreements with EPA. The states conducted
approximately 1,300 PCB compliance inspections during fiscal
1989.
EPA also formalized cooperative enforcement agreements to
monitor compliance with asbestos regulations in Arizona,
Colorado, Idaho, Iowa, Maryland, New Hampshire, Oklahoma, Texas,
Vermont, West Virginia, and Wisconsin. In addition, New Mexico
received EPA approval to expand its cooperative agreement to
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address asbestos as well as PCBs. The states conducted about 800
asbestos compliance inspections in fiscal 1989.
Compliance Actions
EPA conducted a broad range of inspections for TSCA
compliance during fiscal 1989. In cooperation with 16 state
agencies under the terms of enforcement grants-in-aid, EPA
conducted 2,456 PCB compliance monitoring inspections. Also, the
agency conducted 1,548 asbestos inspections under cooperative
agreements with the American Association of Retired Persons and
Arizona, Colorado, Idaho, Iowa, Maryland, New Hampshire, New
Mexico, Oklahoma, Texas, Vermont, West Virginia, and Wisconsin.
EPA also monitored compliance with TSCA sections 4, 5, 8,
and 13 requirements. Nine laboratories were inspected to
determine if they were in compliance with Good Laboratory
Practice requirements. During these inspections, the agency
completed 27 audits of health and environmental tests to
determine if testing had been done according to test protocols
and if reports accurately reflected study findings. EPA also
conducted 507 inspections to determine compliance with section 5
and 8 requirements.
International Cooperation
EPA signed Memoranda of Understanding with the Netherlands
and with the Federal Republic of Germany regarding Good
Laboratory Practice programs. Each Memorandum of Understanding
calls for the reciprocal recognition of each country's Good
Laboratory Practice compliance program, acceptance of test data
generated in each country for evaluation of safety, and
implementation of procedures for continuing mutual cooperation
between the countries.
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Civil Enforcement Actions
EPA issued 415 administrative complaints in fiscal 1989
under TSCA section 16. Another 319 civil action cases were
completed during the year with total penalties exceeding $4
million. Over 1,300 cases are pending resolution. Table 8-1
provides the number of cases and penalties by region for fiscal
1989 and since the beginning of the enforcement program.
Among the most significant actions were seven cases filed
and settled in fiscal 1989 involving chemical substances imported
in violation of sections 5 and 13 premanufacture notification
and import certification requirements. More than $1.2 million in
total penalties were collected in these cases.
EPA completed its first full year of enforcement of the
EPCRA section 313 toxics release reporting requirement. The
agency accomplished 755 on-site facility inspections and issued
more than 110 administrative complaints, with proposed penalties
exceeding $4 million. These accomplishments were the result of
two major enforcement initiatives, which consisted of
coast-to-coast filings of administrative complaints and attracted
significant media attention. Packaging the complaints maximized
EPA's enforcement leverage and led to an increase in the greater
number of companies reporting their emissions.
EPA also issued administrative complaints against four
federal facilities during the year. The Air Force, Coast Guard,
and two Department of Energy contractors operating federal
facilities were issued complaints for PCB violations. Civil
penalties were collected from the DOE contractors. Summaries of
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Table 8-1. 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
8
9
10
HQ
No.
Cases
Issued
FY '79-'89
208
593
395
362
1,007
390
503
430
258
355
70
No.
Cases
Issued
FY '89
21
29
57
13
86
24
42
43
19
60
21
No.
Cases
Completed
FY »79-'89
138
479
269
219
808
319
248
325
223
149
45
No.
Cases
Completed
FY '89
16
34
45
15
87
20
19
23
21
31
8
NO.
Cases
Pending
FY '89**
70
114
126
143
199
71
255
105
35
206
25
Civil
Penalties
Collected
in FY '89
$ 241,050
356,070
543,180
113,970
489,225
78,850
121,112
97,380
115,080
407,064
1,506,979
Civil
Penalties
Collected
in FY '79-89
$ 1,481,439
3,910,387
2,115,293
785,467
6,616,801
1,947,619
1,018,292
1,031,045
1,428,000
1,230,570
7,321,994
Total 4,571
415
3,222
319
1,349
$4,069,990
$28,886,907
* All actions taken involve alleged violations of TSCA sections 4, 5, 6, 18, and 13.
** Includes cases carried over from fiscal years 1979 to 1988.
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these and other civil enforcement actions during fiscal 1989
appear in Appendix G.
NEXT ... Chapter 9 discusses litigation and citizen's petitions
under TSCA.
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9. Litigation
Lawsuits are filed against EPA under TSCA either to compel
EPA to undertake certain actions or to invalidate actions the
agency has already taken.
In the past, the greatest amount of defensive litigation
under TSCA involved PCBs. There was extensive litigation on PCB
rulemaking resulting from the 1980 decision invalidating EPA's
original PCB rules. All PCB litigation after 1980, however, has
resulted in EPA agreeing to conduct additional rulemaking.
Fiscal 1989 saw the end, for all practical purposes, of PCB
litigation resulting from the 1980 decision. Formal ending of
all cases occurred in fiscal 1990. Currently, there is only one
significant active PCB lawsuit, a challenge to EPA's approval of
a PCB disposal facility in Henderson, Kentucky. Occasionally,
defendants in PCB administrative enforcement cases appeal
judgments to the U.S. Court of Appeals.
The largest number of cases in the past few years are those
challenging EPA actions under section 4(a) of TSCA to reguire
testing of chemicals. Nine cases have been filed. Two were
filed in the early stages of the agency testing program by the
Natural Resources Defense Council, a public interest group. The
earliest case, in 1980, compelled EPA to increase the speed of
its testing program. The next case, in 1984, invalidated aspects
of EPA's negotiated testing agreements. Seven cases have been
filed over the past few years by the industry groups challenging
test rules. Three of these cases—on fluoroalkenes,
ethylhexanoic acid, and mesityl oxide—have resulted in opinions
by the U.S. Courts of Appeals. A case on cumene was decided in
April 1990. The other cases are settled or are in the process of
being settled.
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The first two cases upheld EPA's authority to require
testing under TSCA section 4(a)(1)(A). The court in the mesityl
oxide case remanded the rule to EPA, and EPA is negotiating a
testing consent order to require testing of mesityl oxide. The
cumene decision required EPA to articulate standards for
requiring testing under TSCA section 4(a)(1)(B), and EPA is
working on establishing such criteria.
EPA has been sued under the section 21 citizens' petition
provision to compel the agency to regulate dioxins, to require
testing of certain chemical substances present in the environment
of the southwest of Chicago, to regulate asbestos in buildings,
and to amend its PCB regulations. The dioxin case has been
settled. The Chicago testing case is still pending, after having
originally been filed in 1985. A challenge to the
constitutionality of section 21 was dismissed by the court during
fiscal 1989. Procedural motions in the PCB case were decided in
1990. One asbestos case, filed by the Service Employees
International Union (SEIU), was effectively mooted by passage of
AHERA, which dealt with the issues raised in the suit. SEIU also
sued the agency in U.S. District Court for denying its citizens'
petition to commence a rulemaking affecting asbestos in public
and commercial buildings. As of the end of fiscal year 1989,
activities in this suit were being held in abeyance pending a
policy dialogue that SEIU anticipated would lead to the beginning
of rulemaking.
In 1989, EPA completed its successful defense of its
asbestos in schools regulation mandated under AHERA, when the
Supreme Court denied a review requested by the National Gypsum
Company of a U.S. Court of Appeals ruling in the agency's favor.
New major cases filed in fiscal 1989 involved challenges to
EPA's asbestos activities. The most important was the challenge
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to the agency's regulation banning use of asbestos in most
products. Eight petitions for review were filed in the U.S.
Court of Appeals. The case is pending.
Finally, in the last few days of fiscal 1989, the state of
Colorado requested a U.S. District Court to declare that schools
for physically and emotionally disabled children run by its
Department of Institutions are exempt from AHERA provisions
requiring management of asbestos in schools. The basis for the
Colorado suit is a law enacted by its legislature specifically
exempting those schools from AHERA. Various procedural issues
are being decided in this case.
A petition for review was filed several years ago with
respect to the first significant new use rule under TSCA section
5(a)(2). That case has been settled.
A summary of cases during fiscal 1989, including citizens'
petitions and other challenges, is provided in Appendix H.
NEXT ... Chapter 10 discusses how EPA works with other federal
agencies and the international community to assess and manage
chemical risks.
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10. RELATIONSHIP OF TSCA TO OTHER FEDERAL AND
INTERNATIONAL ACTIVITIES
Interagencv Activities During Fiscal 1989
Section 9(d) of TSCA requires that EPA report annually on
its efforts to coordinate its TSCA activities with related
activities of other federal agencies.
EPA continues to negotiate Memoranda of Understanding with
other federal agencies regarding confidential business
information submitted to the agency under TSCA. EPA's statutory
obligation is to safeguard confidential business information.
So, the agency's approach to sharing data, while as flexible as
possible, is constrained by its legal responsibilities. In
specific instances, EPA has worked with companies to have them
provide confidential business information directly to another
federal agency when that agency is unable to meet EPA's
requirements for protecting data.
Currently, NIOSH is considering the need to enter into an
Memorandum of Understanding on data-sharing with EPA, and the
U.S. Customs Office has expressed some interest in accessing TSCA
Confidential Business Information.
EPA also receives recommendations on existing chemical
testing priorities from the Interagency Testing Committee,
established under section 4(e) of TSCA and composed of
representatives from EPA, OSHA, NIOSH, NIEHS, NCI, NSF, DOC, and
CEQ . EPA has also solicited the participation of FDA5 , CPSC,
4
CEQ - Council on Environmental Quality, NIEHS - National
Institute of Environmental Health Sciences, NCI -
National Cancer Institute, NSF - National Science
Foundation, DOC - Department of Commerce
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and NIOSH in a multi-media risk assessment of PCDDs and PCDFs.
During fiscal 1989, the Office of Toxic Substances
continued to work with the ONE Committee (OSHA, NIOSH, EPA).
Composed of the three federal agencies most concerned with
occupational safety and health and worker exposure, this group
meets monthly. Its primary aim is communication, coordination,
and cooperation both on actions related to specific chemicals and
on broad issues associated with programs administered by these
agencies. Work on such chemicals as acrylamide, asbestos, lead,
cadmium, and solvents took place during 1989 and continues to the
present time.
The development and promulgation of the Asbestos Ban and
Phase-out Rule benefited greatly from the cooperation and advice
of OSHA and CPSC. EPA is also coordinating with OSHA with
respect to worker protection aspects of the EPA's
asbestos-in-buildings program.
EPA has also signed a Memorandum of Understanding to support
HUD's efforts in mitigating risks from lead-based paint.
International Activities During Fiscal 1989
EPA's major TSCA-related international activities during
fiscal 1989 were with the OECD and are listed here.
1. Expert Meeting on OECD Clearinghouse (Copenhagen,
January 1989).
Decisions were reached concerning the role of
clearinghouses within the OECD and agreement made on the
general objectives, scope, and expected results of
FDA - Food and Drug Administration
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clearinghouse efforts. Clearinghouses represent an
important vehicle for developing cooperative,
multinational efforts on existing chemicals as part of
the OECD's effort to share the burden. The United
States is an active participant in a majority of the
20-plus clearinghouses.
2. 12th Joint Meeting of the OECD's Chemicals Group and
Management Committee (Paris, March 1989).
The 12th Joint Meeting endorsed a recommendation on
monitoring compliance with Good Laboratory Practice
requirements. This draft decision was supported by the
United States. The 12th Joint Meeting also reviewed and
endorsed clearinghouse efforts to come up with a way to
obtain testing and assessments of the highest volume
chemicals in the OECD countries.
3. Screening Information Data Set Effort on High-
Production-Volume Chemicals (SIDS/HPV).
During fiscal 1989, the OECD successfully got under
way efforts to assemble an inventory of the 1,000
chemicals produced in the largest quantities in OECD
countries. After sorting the chemicals according to
data availability, a subset of 150 priority chemicals
will be developed. Screening tests will then be used to
assess the risks of the chemicals internationally and to
set priorities by the OECD.
The United States has actively sought international
cooperation in testing and assessing existing chemicals
and was an active participant in this successful effort,
which was led by Sweden and the Federal Republic of
Germany. At the 13th Joint Meeting in November 1989,
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member countries agreed that a basic level of test data
is needed on these high-production-volume chemicals, and
they committed to an international effort.
These data are referred to as the Screening
Information Data Set (SIDS). While the scope of the
test set is relatively limited, the OECD agreement to
test 147 chemicals is a major achievement and an
important first step in international cooperation.
For most countries, including the United States, the
responsibility and cost of testing will be borne by
industry as part of a voluntary and cooperative effort.
At least 18 OECD countries will participate in the
testing program. Chemicals will be tested for the
following parameters:
Basic chemistry
Environmental fate
Acute/chronic ecotoxicity
Acute toxicity
45-day sub-chronic toxicity test with
reproductive and developmental screens
Mutagenicity
The development of the U.S. position on this
agreement was facilitated by the Conservation
Foundation and involved participation of interest groups
and industry. The chemicals are currently being divided
among member countries. The United States will be
responsible for testing about 25 percent of the
substances—other countries will test the rest. It is
anticipated that up to 450 chemicals will be handled via
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this cooperative testing and assessment program over the
next five years.
4. United States/Federal Republic of Germany
Cooperative Effort.
The governments and industry of the United States
and the Federal Republic of Germany agreed in June 1989
to conduct a series of tests on 2,4-dinitrotoluene, a
chemical of common interest to both countries. Testing
will be done voluntarily by industry in both nations.
5. 13th Joint Meeting of the OECD's Chemicals Group and
Management Committee (Paris, November 1989).
The 13th Joint Meeting agreed to undertake an effort
to test and assess high-production-volume chemicals
using an approach involving sponsor countries and
voluntary testing by industry. (See item 3 above for
more information.)
6. OECD Workshop on New Chemicals Notification
Procedures (Paris, November 1989).
This workshop brought together representatives from
almost all OECD countries to discuss their approaches in
dealing with new chemical notification schemes. The
workshop was quite successful and several important
recommendations were developed.
Of importance to the United States was the
recommendation that it collaborate with the European
Community (EC) in a study in which the United States
would:
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assess the hazards of a series of new chemicals
in the EC by analyzing SARs; and
compare the results of the SAR analysis with
the results of the Minimum Premarket Data
(MPD) tests that the EC requires be done on
new chemicals.
The study's objective is to determine the degree to
which U.S. SAR analyses would have changed had the MPD
been available during initial assessment. (Section 5 of
TSCA does not require submission of a base set of test
data as part of the premanufacture notification.) While
carrying out the study, the United States will evaluate
the value of MPD in improving our calls. Efforts have
been initiated to work with the Commission of the
European Community in designing and implementing the
study.
The study is similar to the so-called Retrospective
Study, which was proposed in 1984 but never carried out
due to inadequate funds.
7. Hazard Assessment Advisory Body (HAAB).
The HAAB advises the Joint Meeting on hazard/risk
assessment issues. Within the HAAB, the United States
is collaborating with the Netherlands in three projects.
These efforts focus on different aspects of
environmental risk assessment: extrapolation from lab
studies to field effects; use of SARs in screening and
regulating chemicals; and approaches to assessment of
contaminated sediments.
NEXT ... Chapter 11 discusses TSCA-related research and
development activities in EPA during fiscal 1989.
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11. RESEARCH AND DEVELOPMENT
Background
Research on chemical substances is performed to support the
needs of TSCA. Efforts are geared toward evaluating the risks
associated with manufacturing and using new and existing
chemicals, and in developing engineering controls to mitigate
that risk.
The research program is centered on improving the
predictability of human-risk estimates and developing better ways
of performing environmental risk assessments—including
development of exposure monitoring systems, environmental fate
and effects methods, and assessment guidelines.
Additional research develops and evaluates release and
control methods for new and existing chemicals, SARs as
predictors of chemical fate and biological effects, and
procedures for ensuring the human and environmental safety of the
products of biotechnology-
Manor Research Issues
Indoor air exposure. A frequent exposure medium encountered
in TSCA risk assessments is indoor air. This has been the case
for formaldehyde, chlorinated solvents, and paradichlorobenzene
projects, among others. As part of the process of assessing
risk, it is necessary to perform an exposure assessment. A
common way to do this is to model the indoor air concentration
levels of the chemical of interest. EPA's Office of Research and
Development developed an indoor air exposure model to be used for
indoor air exposure assessments. The Office of Research and
Development also developed a procedure to test the performance of
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the model against measured concentrations of chemicals in indoor
air.
Test methods development. TSCA enables EPA to require
companies to test selected existing chemicals for toxic effects.
EPA is responsible for providing guidance for testing and
evaluating the toxic properties of such substances. The ultimate
goal is to develop short-term, cost-effective, predictive methods
for detecting and assessing the toxic effects of chemicals.
The Office of Research and Development conducts a program
for conducting such tests, including methods and protocols for
acute, chronic, and sublethal effects testing and appropriate
guidelines for their use. These are sometimes performed to
evaluate questionable data or to provide data where otherwise not
available. Research provides carefully screened bioassays and
other methods for measuring and analyzing chemicals and dose, for
improving monitoring, for determining human and environmental
effects such as carcinogenic, reproductive and immunotoxic
problems and to reduce the uncertainties associated with risk
assessments. Research products support the TSCA regulatory
policy and decisionmaking process.
Structure-activity relationships. The SAR is key to
quickening the pace of regulatory reviews. It allows EPA to
evaluate a chemical based on the similarity of its molecular
structure to chemicals with known toxic activity- Using the SAR
approach, chemicals can be grouped together to allow rapid
determination of probable toxicity and environmental risks.
The SAR approach is proving vital for reviewing and
screening new chemical substances under section 5 of TSCA, and
for evaluating other chemical pollutants as well. The research
includes ongoing accumulation of data on plant uptake, on fate of
organic chemicals, on fish toxicity and reactivity of chemicals
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in air. Methods and models which can predict toxicity,
bioaccumulation, and kinetics of biotransformation are being
refined based on new information, to provide more accurate
predictions or expand the class of chemicals that may be
included. Computerized expert systems for estimating reactivity
parameters and persistence of toxic chemicals in aquatic and
terrestrial habitats are being developed and used.
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 indicators of dose or
effects are being related to environmental levels of exposure.
Data are also being developed on adverse effects as measured by
traditional epidemiological studies.
Ecology: transport/fate/field validation. To evaluate the
likely problems a toxic chemical may cause in the environment, it
is necessary to understand probable chemical exposure
concentrations and durations, movement through ecosystems,
degradation rates and products, effects, and residue sites and
levels. More specifically, the Office of Research and
Development is establishing a scientific information resource on
how plants, animals, and entire ecosystems are affected by toxic
substances. In the research program, techniques are developed,
validated, and used to assess hazards and exposures and to
estimate the fate of toxic chemicals. This provides the basis
for designing mathematical models capable of predicting chemical
transport, transformation, and fate.
Among the many related issues included are intermedia
transfer, chemical specific characterization (e.g., chemical
photolysis and hydrolysis rate constants), processes of the
receiving environment, comparative toxicological responses,
system level effects (community alterations), effects of
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toxicants on plant and animal development, recovery, persistence,
and bioaccumulation. There is an emphasis on using and
developing state-of-the-art science techniques to fill recognized
data gaps, to determine potential adverse impacts of an
increasing list of toxicants, and to help formulate preventive or
remedial actions that are scientifically credible and legally
defensible.
Health: markersf dosimetry. and extrapolation. Research on
health effects is focused on developing methodologies to
extrapolate data from high to low doses and between mammalian
species in order to enhance human health risk assessment
predictability. Additional studies involve defining the
relationship between biological markers of exposure and
non-cancer health endpoints, such as neurotoxicity and
immunotoxicity, as well as genotoxic endpoints. Dosimetry
studies are examining dermal and inhalation routes of exposure.
Extrapolation research is focusing on genetically mediated health
effects.
Exposure monitoring. The major TSCA-related monitoring
research efforts are 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 that generate data which will provide an
estimate of total human exposure. EPA is also conducting studies
to incorporate environmental dose into personal exposure monitors
to provide a better understanding of the contribution of
different exposure routes to pollutant intake.
The National Human Adipose Tissue Survey (NHATS) continued
to collect and analyze tissue specimens to provide exposure data.
NHATS analyzed the specimens for dioxins and furans,
diphenylethers and semivolatile organic compounds. The National
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Academy of Sciences will submit a report on its review of the
NHATS program in 1991.
Biotechnology. Certain microorganisms fall within the
regulatory framework of EPA under TSCA. EPA is developing
procedures to assess the potential risks and benefits of the use
of these microorganisms. As a cooperative adjunct, a research
program has been initiated to develop evaluative methodology and
gather scientific information that would identify and adequately
describe effects on the environment that may result from the
introduction of genetically altered microorganisms into the
environment.
Six areas of research were identified as essential for risk
assessment:
development of methods for the detection and enumeration
of novel organisms in complex environmental samples;
determination of survival and growth in the environment;
assessment of the stability and transfer frequency of
introduced genetic material in the intracellular and
extracellular environment;
development of data and predictive models for transport
from the point of application or release to other
locations;
detection of adverse environmental response (ecological
effects, toxicity, host range change, etc.) due to the
introduced organisms; and
determination of changes in host range.
Each of these areas is currently being investigated by
selected research laboratories. The strategy for program
development has, as a critical component, established an in-house
scientific staff to build the necessary information database and
to develop appropriate methods and protocols for risk assessment.
Concurrently, staff scientists share responsibility for
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developing a complimentary extramural program and interactive
information exchange with scientists in the fields of genetics,
biochemistry, ecology, and microbiology-
The program deals with both recombinant and non-recombinant
bacteria, fungi, and viruses. In all areas, a primary objective
is to produce appropriate scientific information for developing
protocols.
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 research is focused on the evaluation of
experimental data on kill-tank efficiency and development of risk
management models reflecting loss-prevention techniques for
large-scale premanufacture notification processing facilities.
Engineering release and controls. In the new chemicals
area, models, based on workplace exposure and release of existing
chemicals, are being developed. These models will assist in
predicting workplace exposure for classes of new chemicals that
the agency does not have adequate information. Treatability of
dyes in wastewater is ongoing. Model development is under way
for predicting glove permeation. In the asbestos-research area,
efforts are focused on verifying the adequacy of guidance for
schools, and in developing control strategies for maintaining
effective work area isolation under negative air pressure in tall
buildings. Establishing priorities of the major-release
chemicals is under way to support the EPCRA section 313 reporting
requirements.
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Ecology: ecotoxicitv and risk assessment. In 1986, the
Office of Research and Development initiated a comprehensive
research program in response to the recognized need of the toxic
substances program to improve the capability for assessing and
predicting chemical risk to ecosystems. Several goals were
established for this research: . .
identify critical ecological components for assessment;
develop techniques for extrapolating laboratory and
limited field data to other systems;
provide systematic procedures to permit consistent
ecological evaluations among analysts; and
provide insights into a better understanding of the
consequences of environmental insult from chemicals.
The Office of Research and Development's approach is
primarily one of developing system-independent mathematical
models and protocols for exposure and hazard assessment and
embedding them in a computer-based "Decision Support System."
This system will provide convenient access to these scientific
tools essential for completing ecological risk assessment.
To achieve its goal, the Office of Environmental Processes
and Effects Research, of the Office of Research and Development,
has established an Ecological Risk Assessment Research Program
which relies heavily on results from EPA's base chemical exposure
and hazard assessment research and development efforts. The
major emphasis in the current program is to integrate results
from these two areas to provide the scientific basis for
assessing ecological risks. The present state of the art of
research in chemical exposure and hazard evaluation has not
adequately covered all subject areas needed to provide tools for
ecological risk assessment. Existing research results, ongoing,
research in the areas of chemical exposure and hazard evaluation,
94
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and complementary new research conducted in this program will
provide a foundation for developing a scientifically sound
ecological risk assessment capability for the agency.
Support. For certain assessments and other toxicological
problems, Office of Research and Development staff members are
often called upon to interpret data or render other technical and
scientific judgments. These are achieved through coordinated
expert reviews, workshops, and topical conferences that draw upon
the internal and extramural scientific community. Special
workshops, symposia, and in-housestraining programs assist in
preparing regulatory staff at the state, regional, and national
levels to apply the information and assessment tools developed
through the Office of Research and Development.
A summary of EPA's TSCA-related research and development
activities is provided in Appendix I.
NEXT ... Chapter 12 discusses other TSCA-related activities and
accomplishments during fiscal 1989.
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12. OTHER TSCA-RELATED ACTIVITIES
Chemical Export Notification Program
Section 12(b) of TSCA requires any person who exports or
intends to export a chemical substance or mixture to notify EPA
if certain regulatory actions have been taken with respect to
that substance or mixture under sections 4, 5, 6, or 7 of TSCA.
Written notice must be submitted for the first export or
intended export to a particular country each year. It must be
postmarked within seven days of forming the intent to export or
no later than the date of export. It must include the name of
the regulated chemical, the name and address of the exporter, and
the section of TSCA under which EPA has taken action.
EPA is then required to send a letter to the importing
country, usually at its Washington embassy, within five working
days after the receipt of the company's export notice. Letters
to foreign embassies include the name of the regulated chemical
exported, a summary of the regulatory action taken, and the name
of an EPA official to contact for further information. Copies of
pertinent Federal Register notices are included.
During the past five years, the number of section 12(b)
notices received by EPA has increased significantly, primarily
because of the number of section 4 final test rules and testing
consent orders promulgated. Table 12-1 shows the growth of the
program since 1985.
From January 1989 through October 1989, EPA responded to
more than 275 inquiries from approximately 20 countries for
additional information on exports. Inquiries were for (1)
shipment-specific information, (2) clarification on the U.S.
export notification process, (3) information concerning section 4
96
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test results, and (4) health/ environmental studies, etc.
Table 12-1. Chemical Export Notifications, Fiscal 1985-89
Fiscal
1985
1986
1987
1988
1989*
* Through 10/15/89
Notices
Received
820
2,000+
2,400
4,200
5,300
No. Chemicals
Subject to
Notification
10
20
40
120
125
Letters Sent to
Foreign Countries
533
869
1,035
2,155
3,100
EPA published a proposed rule on July 12, 1989, to change
notification requirements for section I2(b). The proposed rule
will require exporters to submit a one-time notice for section 4
actions. That is, after the one-time notice for a chemical
subject to section 4 action, no further annual notification is
required. No changes in reporting requirements are proposed for
sections 5, 6, and 7 of TSCA. EPA believes that this change will
provide a more useful notice to foreign governments and reduce
the reporting burden on both EPA and industry.
TSCA Assistance Information Service
Passage of TSCA in October 1976 established EPA's Industry
Assistance Office (IAO)—renamed the Environmental Assistance
Division in 1989—to assist the chemical industry and others in
understanding and complying with requirements of the act. In
1977, the TSCA Assistance Information Service was established to
provide such technical assistance. Since that time, the service
has grown and now supports implementation of AHERA, EPCRA, and
other EPA programs addressing toxic substances. The service also
acts as an information center for labor, environmental groups,
97
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other government agencies, and private citizens. Assistance is
provided by personnel responding to inquiries received by
telephone or by mail.
The volume of information flow has grown as the number of
regulations under TSCA has increased. During 1989 the service
responded to 34,600 telephone calls and more than 2,600 letters.
The service distributed over 82,700 documents in response to
these calls and letters.
TSCA State Program Support
Table 12-2 summarizes funding of EPA's cooperative
agreements with various states under TSCA.
TSCA-Related Reports
A large number of reports covering many different activities
related to TSCA and associated laws are produced every year by
EPA. A number of the more significant reports are listed in
Appendix J, including the National Technical Information Service
number for reports available from that organization.
98
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Table 12-2.
Funding for TSCA State Cooperative Agreements,
Fiscal 1985-91
Fiscal Type of Support
1985 Enforcement support*
Program development**
1986 Enforcement support
Program development
1987 Enforcement support
Program development
1988 Enforcement support
Program development
1989 Enforcement support
Program development
1990 Enforcement support
Program development
1991 Enforcement support
Program development
Amount
$ 1,500,000
705,000
$ 2,201,100
1,523,500
$ 2,200,000
385,000
$ 2,200,000
1,042,645
$ 2,200,000
0
$ 3,110,300
1,500,000
No. Recipient States
11
13
17
21
19
5
21
17
23
0
30 (est.)
21 (est.)
$ 5,100,000 (proposed)
2,000,000 (proposed)
37 (projected)
unavailable
* Enforcement support typically includes support for TSCA section 6
actions, including compliance inspections and case development.
Cooperative agreements are awarded under section 28 of TSCA. In
some cases, EPA may have had more than one cooperative agreement
with a single state in a given year (e.g., separate agreements
for PCBs and asbestos).
** Program development typically has covered support for states to
develop asbestos contractor and inspection training and
certification programs. This does not include Asbestos
Inspection and Management Plan Assistance Program monies in
fiscal 1987 and fiscal 1988 of $20 million for local education
agencies. Projected program development funding for fiscal 1991
includes first-time funding of $1 million for the TRI and $0.5
million for PCBs.
99
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SECTION III,
APPENDICES
100
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APPENDIX A
Major Fiscal 1989 TSCA Actions
Section
of Law
Description
Date
4(e)
23rd Interagency Testing Committee (ITC) 11/16/88
report to the Administrator (53 FR 46262).
24th ITC report to the Administrator 07/27/89
(54 FR 31248).
4(a)
Test Rules;
Hexafluoroproylene Oxide (2nd ITC List).
Notice of proposed rulemaking termina-
tion. Manufacturing and processing
information demonstrated that workplace
exposure is being controlled and is not
expected to present unreasonable risk
to health (53 FR 40244).
Commercial Hexane (non-ITC). Notice of
proposed rulemaking reproposes the
pharmacokinetics test requirements and
the associated test guideline (53 FR
45289).
Pentabromoethylbenzene (15th ITC list).
Withdrawal of proposed rule for
chemical fate and environmental
effects. Data received by EPA since
proposal of test rule indicate no
ongoing or intended manufacture or
processing of the substance (53 FR
47228).
Oleylamine (13th ITC list). Notice of
final rulemaking requires that certain
TSCA health effects test guidelines be
used as the test standards for the
required studies, and that test data be
submitted within specified times (53 FR
48542).
10/14/88
11/09/88
11/22/88
12/01/88
101
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Section
of Lav Description Date
Test Rules;
Tributyl Phosphate (18th ITC list). 08/14/89
Notice of final rulemaking requires
manufacturers and processors to perform
tests for health effects, environmental
effects, and chemical fate (54 FR
33400).
1,1,1-Trichloroethane (2nd ITC list). 08/23/89
Consent order to perform mutagenicity
and neurotoxicity tests (54 FR 34991).
This rule constitutes an additional EPA
response to the ITC. In 1984, EPA
issued a final Phase I test rule
requiring developmental toxicity
testing.
Methyl Ethyl Ketoxime (19th ITC list). 09/13/89
Notice of final rulemaking requires
manufacturers and processors of methyl
ethyl ketoxime to perform tests for
health effects (54 FR 37799).
Test Standards/Guidelines/Procedural Rules:
Technical amendments to certain chemical 12/06/88
fate and health effects test
guidelines; final rule (53 FR 49148).
Mouse visible specific locus test require- 12/23/88
ment; proposed amendment in test rules
(53 FR 51847).
Testing consent agreements and test rules; 05/17/89
proposed rule (54 FR 21237).
Technical Amendments to test rules and 06/29/89
consent orders; final rule (54 FR
27352).
TSCA test guidelines—technical amend- 07/14/89
ments; final rule (54 FR 29715).
102
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Section
of Lav
Description
Date
Test Standards/Guidelines/Procedural Rules;
TSCA good laboratory practice standards; 08/17/89
final rule (54 FR 34034).
Procedures governing testing consent 09/01/89
agreements and test rules; interim
final rule (54 FR 36311).
5(a)(2) Significant new use rules; general 07/27/89
provisions for new chemical follow-up—
final rule (54 FR 31298).
Pentabromoethylbenzene. Withdrawal of 11/22/88
proposed test rule; proposed signifi-
cant new use of chemical substances (53
FR 47228).
Mixture of 1,3-Benzenediamine, 2(or 4)- 12/28/88
Methyl-4,6(or 2,6)-Bis(Methylthio)-.
Proposed determination of significant
new uses—proposed rule (53 FR 52443).
Benzenamine,4-Chloro-2-Methyl-Benzen- 03/27/89
amine, 4-Chloro-2-Methyl-Hydrochloride;
Benzenamine, 2-Chloro-6-Methyl. Signi-
ficant new use of chemical substances
—3 chemicals—final rule (54 FR
12445).
Pentabromoethylbenzene. Significant 04/28/89
new use of chemical substance—final
rule (54 FR 18283).
1,3-Benzenediamine, 4-(l,1-Dimethyl- 05/31/89
ethyl)-ar-methyl. Proposed determina-
tion of significant new uses—proposed
rule (54 FR 23228).
Polymers Manufactured Using Free-Radical 06/28/89
Initiators; Clarification of Reporting
Requirements (54 FR 27174).
103
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Section
of Lav
Description
Date
Test Standards/Guidelines/Procedural Rules;
Mixture of 1,3-Benzenediamine, 2-Methyl- 09/18/89
4,6-Bis(Methylthio)-and 1,3-Benzenedi-
amine, 4-Methyl-2,6-Bis(Methylthio)-.
Significant new uses—final rule (54 FR
38381).
2,4-Pentanedione. Significant new use 09/27/89
of a chemical substance—proposed rule
(54 FR 39548).
Consent Orders;
5(e) Consent order. Acrylic copolymer, 10/20/88
sodium salt (P88-854)
Consent order. Cyclo-substituted alkyl 10/20/88
prognenoic acid derivative (P88-1445)
Consent order. Dimethyl octenes mixture 10/23/88
and 2-methyl-6-methyleneoctane (P88-1375)
Consent order. Di(substituted)alkyl 10/26/88
hydrogen acid phosphite (P88-1628)
Consent order. Polyester resin 11/07/88
(P88-1540)
Consent order. (P85-567) 11/08/88
Consent order. Unsaturated silyl ester; 12/07/88
Aliphatic silylated amino ester
(P88-388.715)
Consent order. Acrylated polymer 12/21/88
(P88-1109)
104
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Section
of Law
Description
Date
Consent Orders;
Consent order. 4-Methyl-2-phenyl-lH- 12/23/88
imidazole-5-methanol; Substituted
triazine isocyanurate; 2-Methyl-lH-
imidazole, adduct with 1,3 ,5-triazine-
2,4,6(lH,3H,5H)-trione, hydrate (P86-
65 ,66 ,67)
Consent order. Carboxylated novolak 01/05/89
acrylate (P88-1616)
Consent order. Polypiperidinol acrylate- 01/12/89
methacrylate (P88-1304)
Consent order. p-Menthadienes and 01/25/89
m-menthadienes mixture plus 3-c arene,
para-cymene, and camphene (P88-1718)
Consent order. Ainine salt (P85-941) 01/31/89
Consent order. Terpene resin; Poly- 02/06/89
terpene resin (P88-1617,1623)
Consent order. Substituted cresol 02/16/89
(P87-68)
Consent order. Functional acrylate 02/22/89
(P88-2133)
Consent order. Asymmetrical aromatic 02/27/89
diacyl peroxide (P88-862)
Consent order. Phenol, 4,4'-(9H- 03/07/89
fluoren-9-vlidene)bis- (P88-831)
Consent order. Epoxy resin (P88-837) 03/07/89
Consent order. Poly(teiazinyl piper- 03/17/89
azine) (P88-436)
105
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Section
of Law
Description
Date
Consent Orders:
Consent order. 1,2-Epoxybutane, 2- 03/29/89
propenoic acid, dibut, ylene glycol
mono-2-propenoic acid esters, dibut,
1,2-butanediol, 2-hydroxybutyl
acetylate; 1,2-Epoxybutane, 2-propenoic
acid (P87-930,931)
Consent order. 2,5-Dimercapto-l,3,4- 03/30/89
thiadiazole reaction product (P88-1460)
Consent order. Acrylate modified with 04/04/89
urethane (P88-875)
Consent order. Complex alkyl aryl imide 04/05/89
(P88-1514)
Consent order. Dodecanoic acid 04/06/89
(P87-1436)
Consent order. Trimethylopropane fatty 04/11/89
acid diacrylate (P88-2463)
Consent order. Acid functional polyester 05/03/89
with low molecular weight acid (P88-1857)
Consent order. Strain RMB7101; Strain 05/19/89
RMB7201; Strain RMB7401; Rhizobium
meliloti (P88-1116,1118,1120, P89-280
(modification))
Consent order. Alkyleneamine alkylphenol 05/25/89
mannish (P89-388)
Consent order. Fluorene-containing di- 06/02/89
aromatic diglycidyl ether epoxy resin
(P88-997)
Consent order. Fluorene-containing di- 06/02/89
aromatic amine; Fluorene-containing
diaromatic amine (P88-998,999)
106
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Section
of Law
Description
Date
Consent Orders;
Consent order. Bradyrhizobium japonicum; 06/02/89
Bradyrhizobium japonicum; Bradyrhi-
zobium japonicum strains; Bradyrhi-
zobium japonicum (P88-1275,1277, P89-
340/341 (modification))
Consent order. Polyether polyamine 06/06/89
(P88-2334)
Consent order. 2,2,6,6-Tetrakis(bromo- 07/10/89
methyl)-4-oxa-l,7-diol (P87-1273)
Consent order. Quaternary ammonium 07/17/89
compound (P89-116)
Consent order. Substituted diethyl- 08/01/89
succinate (P87-1417)
Consent order. Alkyl amine 08/21/89
(P89-268) (revoked)
Consent order. Substituted phenol 08/31/89
sulfonic acid (P88-2341)
Consent order. Modified fatty acid, 09/12/89
amine salt (P88-1889)
Consent order. Modified phenol 09/20/89
formaldehyde resin (P89-279)
Consent order. Azo compound 09/21/89
(P88-2470)
Consent order. Carbopolycyclicolazo- 09/22/89
alkylaminoalkylcarbomomo-cyclic ester,
halogen acid salt (P88-1682)
107
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Sect ion
of Law Description Date
Consent Orders;
6 Procedures for Rulemaking Under Section 05/19/89
6 of the Toxic Substances Control Act-
-Final Rule (54 FR 21622)
Asbestos. Manufacture, importation, 07/12/89
processing and distribution in commerce
prohibition—final rule (54 FR 29460)
108
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APPENDIX B
Chemical Data Received
Under TSCA Section 4(d) in Fiscal 1989
EPA received data on the following 35 chemicals under
TSCA section 4(d) requirements during fiscal 1989:
biphenyl
anthraquinone
hydroquinone
l, 2-dichlorobenzenes
1, 2-dichloropropane
ethyl methacrylate
vinylidene flouride
cresols
tetrabromobisphenol-A
methyl tert butyl ether
1, 2, 4, 5-tetrachlorobenzene
aniline
2, 6-dichloro-4-nitroaniline
2-chloroaniline
propylene dichloride
dichloropropanol
dihydrosafrole
dibromomethane
ortho-cresol
para-cresol
commercial hexane
diethylene glycol butyl ether
methyl chloride
parachlorobenzotrichloride
p-nitrophenol
c9 aromatic hydrocarbon fraction
cumene
4-nitroaniline
2-nitroaniline
oleylamine
3, 4-dichloroaniline
mercaptobenzothiazole
octamethylcyclotetrasiloxane
alkyl phthalates
2, 3, 5, 6-tetrachloro-2, 5-cyclohexadiene l, 4-dione
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APPENDIX C
Summary of TSCA Section 4 Chemical Testing Actions
in Fiscal 1989
Testing in Response to the Interaaencv Testing Committee (ITC)
Date
Chemical
Action
ITC
List
10/14/88 Hexafluoropropylene
oxide
11/22/88
12/1/88
1/9/89
Pentabromoethyl-
benzene
Oleylamine
Alkyl phthalates
1/10/89
OctamethyIcyclo-
tetrasiloxane
(OMCTS)
Termination of proposed
rule; ends rulemaking that
would require mutagenicity,
oncogenicity, and reproduc-
tive effects testing.
Withdrawal of proposed
rule; proposal to require
chemical fate and envi-
ronmental effects testing.
Notice of final rulemaking;
specifies test standards and
reporting requirements for
health effects testing.
Consent order; requires
chemical fate and environ-
mental effects testing of:
dimethyl phthalate;
di-n-butyl phthalate; dihexyl
phthalate; di-2-ethylhexyl
phthalate; di-(heptyl, nonyl,
undecyl) phthalate;
diisodecyl phthalate;
diundecyl phthalate, and
ditridecyl phthalate.
Consent order; requires
chemical fate and envi-
ronmental effects testing.
110
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Date
Chemical
Action
ITC
List
2/24/89
4/3/89
4/3/89
5/17/89
8/14/89
8/23/89
9/13/89
Diisodecyl phenyl
phosphite (PDDP)
Triethylene glycol
monomethyl,
monoethyl and
monobutyl ethers
Triethylene glycol
monomethyl ether
1, 6-Hexamethylene
diisocyanate
Tributyl phosphate
Consent order; requires neu-
rotoxicity testing.
Consent order; requires toxi-
cological testing.
Notice of final rulemaking;
requires developmental
neurotoxicity testing.
Notice of proposed rule-
making; proposes testing for
oncogenicity, mutagenicity,
reproductive toxicity,
developmental toxicity,
neurotoxicity, pharmaco-
kinetics and hydrolysis.
Notice of final rulemaking;
requires health effects,
environmental effects and
chemical fate testing.
1, l, 1-Trichloroethane Consent order; requires
mutagenicity and neuro-
toxicity testing.
Methyl ethyl ketoxime
Notice of final rulemaking;
requires health effects
testing.
22
18
19
111
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Al'l'KNIUX D
Summary of New Chemical Actions in Fiscal 1989
Description
Actions
Fiscal '89
Actions
Mid '79
to
9/30/89
Total Valid New Chemical Substance
Submissions Received (PMNs, Test Market,
Polymer, and Low Volume)
Valid PMNs Received (includes Biotechnology)
PMNs Requiring No Further Action
Voluntary Testing in Response to EPA Concerns
Voluntary Control Actions by Submitters
PMNs Withdrawn in Face of Section 5(e)/5(f)
PMNs Subject to Section 5(e) Consent Orders'5
Section 5(e) Consent Orders Signed
PMNs Subject to Unilateral Section 5(e) Ordersb
PMNs Subject to Section 5(f) Rules
Number of Chemicals for which Commencement
Manufacture Notices Were Received
Submissions of Bona Fide Intent to Manufacture
New Substances Subject to Proposed Significant
New Use Rules (SNURs)
New Substances Subject to Final SNURs
Test Data Received as a Result of Section 5(e)
Consent Orders
Valid Test Market Exemption Applications Received
Granted
Withdrawn
Denied
Valid Polvmer Exemption PMNs Received
1,493 15,333
1,032 12,597a
1,477 10,501
53 245
0
69
53
4
0
0
45
330
435a
233
16
4
890C 5,126
467 3,884
60
16
8
28
22
3
0
174e
39
503
437
43
7
1,135
112
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Actions Actions
Mid '79
to
Description Fiscal '89 9/30/89
No Further Action Required
Withdrawn
Converted to Conventional PMNs
Valid Low Volume Exemption Notices Received
No Further Action Required
Withdrawn
Ineligible
313
3
0
259e
278
5
0
1,052
137
16
1,090
1,079
28
1
a: Includes 106 synfuel PMNs.
b: A section 5(e) consent order is issued by EPA with the agreement
of the PMN submitter. A section 5(e) unilateral order is issued by
EPA without the agreement of the submitter.
c: This number includes PMNs received in previous fiscal years for
which commencement of manufacture notices were received in fiscal
1989.
d: This number includes substances which were the subject of PMNs
received in previous fiscal years but for which proposed or final
rules were not published until fiscal 1989.
e: This number includes some fiscal 1988 exemptions that went to
disposition in fiscal 1989.
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APPENDIX E
Summary of TSCA Section 8 Information Submissions
and Actions in Fiscal 1989
Type of Submission No.
Section 8(a) submissions
Preliminary Assessment Information Rule (PAIR) submissions 114
Comprehensive Assessment Information Rule (CAIR) submissions 640
Follow-ups on prior CAIR submissions 4
Other submissions 3
Section 8(b) additions to TSCA chemical inventory 1,044
Section 8(c) reports of alleged significant adverse reactions 1
Section 8(d) submissions
Health and safety studies or toxicity test data submissions 1,565
Follow-ups to prior submissions 100
Section 8(e) "substantial risk" notifications
Initial notifications 74
Supplemental/Follow-ups to initial notifications 215
Voluntary "For-Your-Information" (FYI) notifications 164
Follow-up FYI notifications 2
Chemical Hazard Information Profiles (CHIPS) completed 5
2,4-pentanedione
piperidinyl-based UV light stabilizers
benzotriazol-based UV light stabilizers
N-cyclohexylthiophthalimide
aromatic ether diamine (generic name)
Lead/Cadmium Substitute Hazard Profiles (no. product categories) 11
batteries (nickel/cadmium, silver/cadmium)
soldered products
electroplating
glass and ceramics
pigments (plastic, rubber)
plastics
brass and bronze (plumbing pipes, valves, gears, bushings)
114
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Summary of the ASHAA Loan and Grant Program, Fiscal 1985-89
TOTAL
APPLICAN"
LEAs
Schools
Pro j ects
Costs
FS 1985
1,107
5,095 1,
8,548 2,
$535. 8M $211
TOTAL QUALIFIED APPLICANTS**
LEAs 587
Schools
Projects
Costs
TOTAL AWARI
LEAs
Schools
Projects
Award
1,832
2,847 1,
$186. 6M $93
198
340
417
$45. OM $47
1986
371
211
389
.6M
241
644
247
.6M
173
295
421
.OM
1987-1*
292
1,030
1,967
$162. 5M
136
408
774
$41. 4M
133
366
663
$34. 2M
1987-2
340
1,015
1,769
$177. 9M
208
489
820
$94. 7M
35
56
66
$8.0 M
1988*
328
986
1,722
$170. 3M
185
441
721
$79. OM
103
187
226
$22. 6M
1989
1,110
2,383
4,125
$367. 7M
682
1,361
2,093
$123. 2M
231
327
401
$ 45 . OM
TOTALS
873
1,571
2,194
$201. 8M
Public Award $39.8M(88%) $41.4M(88%) $29.1M(85%) $ 7.32M(91%)$19.8M(88%) $40.6M(90%) $178.0M(88%)
Private Award $5.2M(12%) $ 5.6M(12%) $ 5.1M(15%) $ 0.6M(9%) $ 2.8M(12%) $ 4.4M(10%) $ 23.8M(12%)
Loan Award $33.2M(74%) $34.3M(73%) $24.6M(72%) $4.3M(54%) $15.4M(68%) $25.4M(56%) $137.2M(68%)
Grant Award $11.8M(26%) $12.7M(27%) $ 9.6M(28%) $3.7M(46%) $ 7.2M(32%) $19.6M(44%) $ 64.6M(32%)
Exposure-hours
Reduced 4.7M 3.5M 2.5M 0.544M 2.02M 4.02M 17.3M
* Only unfunded 1986 applications were considered for 1987-1. Only unfunded 1987-2 applications were
considered for 1988 awards.
** Reflects those determined qualified after EPA technical review: ACM friable, damaged, and exposed
or in air plenum and local education agency (LEA) within lower 70% of U.S. school districts, based
on public school per capita income or private school budget per pupil.
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APPENDIX G
Civil Enforcement Actions
Expanded Case Summaries
U.S. v. Boliden Me tech; An EPA Administrative Law Judge (ALJ)
issued a decision including assessment of a $32,000 penalty in
this Region I case involving PCB violations at the Boliden Metech
site in Providence, RI. Boliden was found to have violated TSCA
when it improperly stored and disposed of PCB-contaminated
shredded metal and debris. Boliden shreds used computers and
electronic equipment. This case was vigorously contested and is
currently the subject of a companion case filed in the United
States District Court of Rhode Island.
The ALJ's opinion had several significant aspects: (1) it
is not always necessary to take a "representative sample" to
prove a violation of the PCB regulations; (2) procedures for
taking samples set forth in the TSCA inspection manual are
"guidelines". Failure by EPA to follow sample collection
procedures of TSCA "are not fatal" and does not destroy the
validity of the samples; (3) EPA is not required to prove that
spilled PCBs were released into the surrounding soil to prove
improper disposal; (4) the PCB regulations require analysis "by
any scientifically valid method"; (5) EPA's PCB tests are
reliable; and (6) sampling outside a company's property (in this
case sampling in the Providence River) does not violate
unreasonable search and seizure prohibitions of the Fourth
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Amendment to the Constitution. This decision supports EPA's
efforts to regulate the storage and disposal of PCB-contaminated
shredded material and debris. A companion action seeking an
injunction and remedial order was filed in the District Court of
Rhode Island in May 1989.
In the Matter of the City of Detroit; A decision was issued in
this case finding that the city of Detroit has violated the PCB
regulations at four sites in Detroit where PCBs were spilled at
levels in excess of 500,000 parts per million (ppm). A penalty
of $264,000 was imposed for the violations.
In the Matter of Dow Chemical Company; EPA filed a TSCA civil
administrative complaint against Dow Chemical Company (Dow), on
June 16, 1987. The complaint charged Dow with 227 counts of
illegal manufacture of a new polycarbonate plastic, without
having first submitted a premanufacture notice (PMN)in accordance
with TSCA section 5. On September 20, 1989, the Chief Judicial
Officer approved a settlement of the action which requires Dow to
pay a $405,200 civil penalty. The settlement figure takes into
account numerous actions and expenditures undertaken by Dow to
address the cause of the violations, including comprehensive
internal audits and improved training programs.
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in the Matter of Ensco. Inc; EPA's right to inspect PCB
facilities were strengthened in June 1989, when an EPA ALJ
rejected the company's attempt to limit agency inspections. In
May 1989, Energy Systems Co., Inc. (Ensco) filed for an
authorization to conduct discovery. In support of this legal
action, Ensco said EPA inspections of its PCB and hazardous waste
incineration facility at El Dorado, AR, were so much more
frequent than at any other facility that they were
unconstitutional under the due process and equal protection
clauses of the Constitution. Under a 1986 contract with EPA,
Ensco is permitted to dispose of PCBs at El Dorado. In 1987, EPA
insisted the authorization be amended so that the facility could
be inspected by the state of Arkansas up to three times a day.
The cost of the inspections is borne by Ensco.
In rejecting Ensco's claim, the ALJ said the discovery
request was "actually an attack on the contract entered into with
the state of Arkansas" and that "this is not the appropriate
forum to test the validity of this or any other contract." The
ALJ also ruled that the disposal permit conditions were binding,
and he rejected the company's attempt to claim that EPA's
inspection requirements, which are greater than at other
facilities, were unfair.
In the Matter of Hodaq Chemical Corporation: In early 1988, EPA
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initiated an enforcement action against Hodag Chemical
Corporation of Skokie, IL. EPA's complaint alleged violation of
the PCB use rules for operating a heat transfer system that
contained more than 50 parts per million PCBs for use in (among
other things) the manufacture or processing of food, drugs and
cosmetics. EPA's complaint also alleged violations of the PCB
marking and recordkeeping regulations. Hodag7s defense was that
in 1971 or 1972, Monsanto removed PCB oil from this heat transfer
system long before the promulgation of the PCB rules in 1978.
On November 14, 1988, the ALJ ruled that section 15(1) and
(3) of TSCA established a standard of strict liability, and that
a violation may be found for violations thereof even when the
violation is unknowing. The ALJ went on to rule that as a matter
of law the terms PCB and PCBs include mono-chlorinated biphenyls,
and that when a corporation has knowledge of information in its
files which would trigger a legal duty to act it cannot escape
liability because the particular responsible corporate official
was unaware of that information. A fine of $14,500 was imposed.
In the Matter of Eastman Kodak Co.; In a recent pretrial order,
an EPA ALJ denied a motion by Eastman Kodak Co., to compel
discovery by EPA in a TSCA premanufacturing notice case. The ALJ
also denied a motion seeking "amplified summaries" of EPA's
prehearing exchange. In denying Kodak's motion to compel
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discovery, the ALJ said that although discovery can lead to
admissible evidence and judicial economy, "discovery, as a
litigation art, can be put to inappropriate uses." He also held
that "there is no basic constitutional right to pretrial
discovery in administrative cases." The ruling also affirms that
discovery, other than what is ordered by a judge for pretrial
exchange is to be subject to stringent review by a court.
In the Matter of McCloskey; This administrative enforcement
action was brought pursuant to TSCA, 15 U.S.C. Section 2601 et
seq. In August of 1987, McCloskey voluntarily self-disclosed its
TSCA violations after completing a full audit at its three
facilities. During the conduct of the audit, the respondent
discovered that they had, on multiple occasions, manufactured 26
chemical substances in violation of TSCA section 5, which
requires a person intending to manufacture a new chemical
substance for commercial purposes to submit to EPA a
premanufacture notice at least 90 days prior to the first such
manufacture. The failure to comply with these requirements is a
violation of TSCA Section 15(1)(B). After promptly self-
disclosing these violations to EPA, the respondent then filed the
appropriate TSCA section 5 notices (PMNs, polymer exemption
applications, etc.) for all 26 substances. This includes filing
PMNs on six substances which had been out of production for more
than five years. All chemicals completed the TSCA review without
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imposition of a Section 5(e) or 5(f) order.
On March 7, 1989, EPA and McCloskey agreed to a settlement
which required McCloskey to pay a $615,650 penalty, submit an
article on TSCA compliance to three trade journals, and conduct
an Emergency Planning and Community Right-to-Know Act (EPCRA)
Section 313 seminar for its customers. McCloskey has performed
all of its required duties under this agreement, and has
broadened its EPCRA section 313 seminar to include all of EPCRA
rather than solely the Toxic Release Inventory reporting
requirement.
In the Matter of Minolta Corporation; EPA reached settlement
with the Minolta Corporation resolving violations under sections
5 and 13 of TSCA. Under the administrative consent agreement,
Minolta will pay a $600,000 civil penalty, develop a TSCA
compliance and training program, hold a seminar in Japan on TSCA
compliance, and place advertisements in ten national publications
highlighting TSCA requirements.
In the Matter of Riverside Furniture Corporation; In this case
involving failure to report under section 313 of EPCRA by a Fort
Smith, AR, furniture manufacturer, EPA obtained the first
administrative determination of liability under EPCRA and the
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first administrative decision awarding penalties under this
significant toxic chemical reporting statute. On March 27, 1989,
an ALJ granted EPA's motion for a partial accelerated decision
finding the respondent liable under the act and holding that lack
of knowledge is not a defense to liability under section 313. On
July 26, 1989, EPA prosecuted the first EPCRA administrative
hearing on the assessment of penalties, and on September 28,
1989, the ALJ issued an initial decision, ordering civil
penalties in the amount of $75,000 against Riverside. In the
opinion the ALJ stated that "the success of EPCRA can be attained
only through voluntary, strict and comprehensive compliance with
the act and regulations ... and a lack of such compliance will
weaken, if not defeat, the purposes expressed [in the act]."
In the Matter of Rollins Environmental Services. Inc.; An EPA
ALJ has rejected a claim that a general statute of limitations
restricts EPA from taking an enforcement action under the TSCA.
Rollins Environmental Services, Inc., claimed EPA was precluded
from bringing action in a PCB case because the violations took
place more than five years before the complaint was issued.
Rollins acknowledged that TSCA does not contain a statute of
limitations clause, but argued that the general federal five-year
statute of limitations governing enforcement does apply.
On July 13, the ALJ cited an April 2 ruling in the Tremco
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case (see accompanying case in this section) that the general
federal statute of limitations provision did not apply to EPA
administrative penalty actions under TSCA. The ALJ also rejected
Rollins' claims that since the federal statute of limitations
provision applies to other EPA measures, it should also apply to
TSCA. The judge ruled that the other laws differed from TSCA
because TSCA alone provides for civil penalty assessment with
enforcement left to the federal District Court. The other laws
include enforcement provisions ruling that the clock begins only
when the inspection is made. Rollins also claimed that it did
not violate TSCA when it incinerated kerosene containing less
than 50 parts per million of PCBs in a non-TSCA permitted
incinerator. The judge ruled that the disposal of the PCBs,
although below 50 parts per million violated TSCA because PCBs
cannot be diluted with liquid to avoid proper disposal in a PCB
incinerator.
In the Matter of Schnee-Morehead, Inc.; On January 25, 1989, EPA
filed a civil administrative complaint against Schnee-Morehead,
Inc., for numerous violations of the TSCA section 5
premanufacture notification requirements. The violations
involved four polymers and occurred over many years. The
settlement agreement in this case, filed on January 26, 1989,
requires Schnee-Morehead to pay a $597,000 civil penalty, over
the course of two years.
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In the Matter of SEP Inc.. et al. (TSCA); In a decision issued
December 8, 1988, by the Chief ALJ, the controlling officer of a
defunct corporation was held individually liable for a $35,000
penalty for improper disposal of PCB waste materials by the
corporation he controlled. The ALJ held, following a three-day
hearing, that a corporate agency whose act, default, or omission
causes a corporation to violate TSCA is himself individually
liable for the violation - the first such holding in an
administrative action under this statute. The case involved
liability for PCBs left behind by a corporation which accepted
PCBs for disposal and then went out of business. It was held
that abandonment constitutes improper disposal for TSCA purposes
and that the financial inability of respondents to pay for proper
disposal did not absolve them from liability.
In the Matter of 3M Companyt EPA issued a civil administrative
complaint against the Minnesota Mining and Manufacturing (3M)
Company of St. Paul, MN, proposing a $1.3 million penalty for
numerous violations of TSCA sections 5 and 13. The violations,
which 3M voluntarily disclosed to EPA, involved the failure to
notify EPA prior to importing two new chemicals not on the TSCA
Section 8(b) inventory list and falsely certifying to the U.S.
Customs Service that the illegally imported chemicals were in
compliance with TSCA.
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By interlocutory order dated August 7, 1989, the ALJ granted
judgment for EPA with respect to 3M's liability for all counts
alleged in the complaint. The precedential decision also struck
3M's statute of limitations defense. In striking the defense,
the ALJ found that TSCA's new chemicals provisions are among the
most important and significant provisions of TSCA. A hearing
will be scheduled to determine the appropriate penalty amount to
be assessed against 3M.
In the Matter of Toledo Edison; EPA initiated an administrative
enforcement action against Toledo Edison for violation of the PCB
storage and disposal requirements. A PCB transformer at the
Toledo Edison Davis-Besse Nuclear Power Plant had ruptured,
spilling PCB-contaminated oil into a settling basin that
contained radionuclide contaminated water. Toledo Edison
completed an initial cleanup under supervision of EPA
representatives. The cleanup generated 26 55-gallon drums of
material which were contaminated with both PCBs and
radionuclides. Toledo Edison could not dispose of this waste
within one year as required by the PCB regulations because there
are no facilities licensed to dispose of this type of waste.
Toledo Edison petitioned the EPA administrator for an exemption
from the one-year storage limit; the administrator denied Toledo
Edison's request.
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Negotiations with Toledo Edison resulted in the simultaneous
filing of a civil administrative complaint and a consent order
resolving the complaint. The consent order required that Toledo
Edison: (1) complete the cleanup to PCB rule specifications;
(2) continue good faith efforts to obtain an acceptable disposal
method; (3) store the PCB/radionuclide waste in a more stringent
manner than that required by the PCB regulations; (4) submit
extensive reports; (5) remove all PCB transformers from the
facility; and (6) pay an $18,000 civil penalty.
In the Matter of Tremco: This PMN administrative enforcement
action was brought pursuant to the TSCA, 15 U.S.C. Section 2601
et seq. The enforcement case involved both voluntarily self-
disclosed violations and violations discovered by EPA during the
conduct of a TSCA investigation. In 1983, Tremco had notified
EPA that they had illegally manufactured three chemical
substances. This notification was made in Tremco's cover letter
which transmitted a PMN for each of these substances. Each of
the chemicals completed the TSCA review without imposition of a
section 5(e) of 5(f) order. In 1987, during a routine review of
PMNs, an EPA inspector from the National Enforcement Investiga-
tions Center (NEIC) uncovered the 1983 letter and, based on this
letter, conducted an October 1987 inspection of Tremco's
Barbourville, KY, plant site. The inspector was able to verify
the existence of TSCA violations dating back to 1979 and was able
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to document TSCA Section 5 violations during the PMN review
period which were not self-disclosed in the aforementioned cover
letter.
In 1988, EPA filed an administrative complaint against
Tremco. Tremco responded to the complaint by raising the general
federal statute of limitations (28 U.S.C. section 2462) as an
affirmative defense. EPA moved the court to strike the statute
of limitations defense as inapplicable to TSCA administrative
enforcement actions. On April 7, 1989, the ALJ ruled that the
general federal statute of limitations does not apply. The judge
ruled that statutes of limitation ordinarily do not run against
the United States unless Congress explicitly directs otherwise,
and there is no legislative intent to apply 28 U.S.C. Section
2462 to TSCA penalty proceedings. This important decision allows
EPA to address violative conduct (e.g., improper PCB disposal,
improper asbestos abatement, and illegal chemical manufacture)
which may have initially occurred more than five years prior to
issuance of the complaint, but which continue to pose a risk to
human health and the environment. On July 17, 1989, EPA and
Tremco entered into a consent agreement which required Tremco to
pay a $145,000 civil penalty-
In the Matter of University of Idaho: This enforcement action is
only the second in the nation to be brought under the TSCA Worker
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Protection Rule [40 CFR section 763, subpart G promulgated
pursuant to TSCA section 6(a)] which addresses the protection of
public employees involved in the abatement of asbestos-containing
materials. The state university employees were exposed during a
building renovation and the university was charged with
violations of the asbestos work practice standards. The
university was charged with failure to protect the workers from
asbestos exposure and failure to minimize the hazards involved
during removal of asbestos. A settlement agreement was reached
and under the terms of the signed consent agreement and final
order the university agreed, without admitting liability, to
undertake an extensive program to provide asbestos information to
the community and to the state of Idaho through the
implementation of an asbestos hotline.
U.S. v. USPCI. Inc.: A site inspection and document review
indicated that this facility in Utah failed to adhere to all of
the requirements of the approval issued by the agency under TSCA
for the operation of a commercial PCB dechlorination unit. The
57-count complaint alleged the improper processing of PCBs for 55
separate batches, along with annual document violations for two
years. The agency found no evidence that PCBs had been
insufficiently processed or released to the environment, but the
violations were viewed as serious because such facilities are
permitted by the agency and must therefore be held to a strict
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standard of care. The case was settled for a total expenditure
by respondents of $450,000, including a $175,000 cash penalty,
the purchase of a $118,000 emergency response vehicle for Tooele
County, UT, and the planning and operation of household hazardous
waste collection days in the state.
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APPENDIX H
Citizens' Petitions and Other Litigation
Litigation Challenges to Aaencv Denials of Citizens* Petitions:
Environmental Defense Fund (EDF) and National Wildlife Federation
(NWF) v. Thomas (No. 85-0973, D.D.C.): Plaintiffs brought this
action after EPA had denied, in part, their TSCA section 21
citizens' petition to issue comprehensive regulations under TSCA
on certain isomers of the chemicals known as dioxins. These are
substances chemically similar in structure to 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD) and which, according to
plaintiffs, may present risks similar to TCDD.
In early 1986 plaintiffs filed a motion requesting the court
to order EPA to initiate rulemaking because the agency's
explanation published in the Federal Register was improper as a
matter of law. EPA opposed plaintiffs' request arguing that its
denial was in accordance with statutory requirements. In March
1987, the court denied plaintiffs' motion, stating that under
TSCA the form of the denial does not affect the type of judicial
action permitted under TSCA section 21. The court reasoned that,
when EPA denies a section 21 petition, plaintiffs are only
entitled to a de novo proceeding before the court, regardless of
the reasons stated by the agency.
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In July 1988, EDF and NWF reached a settlement with EPA
under which the agency agreed, within specified time frames over
a number of years, to undertake certain actions relating to
dioxins. Some actions would be under TSCA authority, but many
would be taken under authority of other agency-administered
statutes. Specifically, EPA agreed to consider the appropriate
agency actions to take with respect to (l) commercial chemicals
that testing shows are contaminated with dioxins, (2) activities
at pulp and paper mills that could cause dioxin contamination,
(3) wastes from the wood preservative industry, and (4) air
emissions from municipal waste combustors. In addition, EPA
agreed to issue studies on hospital waste incinerators.
In September 1988, EDF and NWF filed an appeal from the
district court's opinion that they were only entitled to a de
novo proceeding when EPA denied their petition.
Environmental Defense Fund (EDF) and National Wildlife Federation
(NWF) v. EPA (No. 88-5325, B.C. Cir.): In November 1988, EDF
and EPA agreed to a settlement regarding attorneys' fees in the
district court litigation. EPA and NWF were unable to agree on
attorneys' fees and filed briefs on the issue. The court's
decision is pending.
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Citizens for a Better Environment, et al. v. Lee M. Thomas (No.
85 C 08000, N. 111.): In September 1985, two public interest
groups challenged EPA's decision denying their petition filed
pursuant to section 21 of TSCA in April 1985. The petition had
requested EPA to identify business entities in the southeast area
of Chicago which were releasing 11 named chemical substances into
the environment and to initiate rulemaking under TSCA section
4(a) to require 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 that 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
completed.
Two steel companies, which had intervened as defendants,
filed a motion to dismiss the complaint in July 1988. They
argued that TSCA section 21 violates the separation of powers
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doctrine of the U.S. Constitution because it authorizes a federal
district court to order EPA to initiate rulemaking after a de
novo trial. Plaintiffs argued that section 21 was no different
from any other statute allowing a court to review agency
decisionmaking. The court denied this motion, holding that
section 21 does not violate the separation of powers doctrine
because it only authorizes a federal court to order an executive
agency to initiate a rulemaking. The outcome of the rule is
still within the agency's discretion.
Service Employees International Union (SEIU) v. Reilly (No. 89—
0851, D.D.C.): In November 1988, SEIU filed a citizens' petition
under TSCA section 21 requesting EPA to issue rules affecting
asbestos in public and commercial buildings other than schools.
On March 28, 1989, EPA denied the petition stating that it needed
additional information on risk reduction before it could consider
whether to issue the rules requested by SEIU. EPA did not,
however, permanently rule out a regulatory response at some later
time. In addition, EPA announced a public meeting to gather data
and hear arguments to assist the agency in assessing what future
activity is necessary to deal with asbestos in public and
commercial buildings.
On March 31, 1989, SEIU filed suit in federal district court
to compel initiation of a rulemaking. However, the first public
meeting, held in June 1989, convinced EPA to hold further
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meetings. As a result, SEIU asked that its suit be held in
abeyance while the meetings were being conducted, expressing its
belief that the meetings might result in EPA's voluntarily
initiating rulemaking. At the end of fiscal year 1989, the
meeting process was continuing and the SEIU lawsuit remained in
abeyance.
Dr. David G. Walker v. EPA (No. H-87-3552; S.D. Tex., Houston):
In March 1987, Dr. Walker filed a citizens' petition under TSCA
section 21 asking EPA to exclude from its current regulations
polychlorinated biphenyls (PCBs), containing three chlorine atoms
or less. EPA denied the petition on the grounds that in previous
proceedings involving PCBs the agency had already considered, and
rejected, the arguments raised by Dr. Walker. The court is
currently considering various procedural motions raised by EPA
and plaintiff.
OTHER CHALLENGES;
Michael D. Vanderveer and City of Evansville, Indiana v. EPA and
Unison Transformer Services, Inc. (No. EV86-183C, D.C. Ind.) and
Citizens for Healthy Progress, Inc. v. EPA (No. 86-0155, D.C.
Kentucky): These two suits, now consolidated, were filed against
EPA regarding the agency's approval in January 1987 of a PCB
disposal facility in Henderson, Kentucky. At this facility,
operated by Unison Transformer Services, Inc. (Unison), PCBs are
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chemically separated from transformer fluid and are then shipped
to other facilities where permanent disposal takes place.
Plaintiffs requested a permanent injunction against
operation of the facility, stating that EPA needed to consider
criteria applicable under the Resource Conservation and Recovery
Act 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. Plaintiffs also argued
that EPA lacked authority to permit the Unison process under TSCA
regulations and that they were 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.
EPA argues that its approval was in accordance with its TSCA
regulations and that TSCA is the appropriate authority to approve
the Unison facility- The parties are awaiting the court's
decision.
Shell Chemical Co. v. EPA 826 F.2d 295 (5th Cir. 1987): On
January 7, 1986, four manufacturers of mesityl oxide (MO) and the
Chemical Manufacturers Association filed in the Court of Appeals
a petition for judicial review of EPA's section 4 rule requiring
health effects testing of MO. The proceeding was held in
abeyance pending EPA's consideration of the manufacturers'
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petition under section 21 of TSCA to withdraw the test rule. EPA
denied the petition on August 21, 1986 (51 F.R. 30216).
The manufacturers reinstituted the lawsuit and also filed an
action in District Court, on September 26. 1986, challenging the
denial of their section 21 petition. The District Court stayed
the case pending the outcome of the reinstituted lawsuit in the
Court of Appeals.
In August 1987, the Court of Appeals remanded the case "for
EPA to make supplemental findings in the administrative record
concerning the changes in MO use that have occurred since the
testing rule was promulgated and, if determinable, that will
occur in the foreseeable future." (826 F.2d 298) The court
stayed implementation of the rule pending EPA's updated
factfinding.
Since the rule is being reconsidered, the District Court
litigation was dismissed without prejudice to refiling another
citizens' petition should a subsequent rule be issued. EPA and
manufacturers are currently negotiating a consent order to
conduct the testing.
Chemical Manufacturers Association v. EPA (No. 88-1352, B.C.
Cir.): On February 26, 1988. EPA issued a testing rule for
diethylene glycol ether and its acetate (DGBE/DGBA). The rule
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requires three tests to be conducted initially ("first-tier"),
and would require a "second-tier" developmental neurotoxicity
study if the results of the first tier tests are positive. CMA
challenged the requirement for the second tier study. Since the
first-tier tests was not due until September 1989, parties
requested and received a stay of the litigation.
Chemical Manufacturers Association v. EPA (No. 88-4710, 5th
Cir.): On September 26, 1988, CMA and five manufacturers and
processors filed a petition for review of a section 4 rule
requiring testing of the chemical cumene, the thirty-first
highest production chemical in the United States. EPA issued
this rule under the authority of section 4(a)(l)(B), which
authorizes the agency to require testing if it finds that a
chemical is produced in substantial quantities and that it is or
may be released into the environment in substantial quantities or
that there is or may be substantial exposure to the chemical.
Along with its petition for review, CMA filed a motion for
stay of the rule arguing that, pending the decision on the
merits, the manufacturers would be irreparably harmed by being
forced into non-recoverable start-up costs for testing. CMA
argued that these costs would be unfair because CMA was likely to
succeed on the merits of the case. The motion was denied. Oral
argument was held on June 7, 1989.
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CMA did not contest EPA's finding that cumene is produced in
substantial quantities. CMA argued, however, that EPA could not
require testing unless EPA showed levels of cumene in the
environment that would cause harm if cumene were found to be
hazardous. Further, CMA argued that, to require testing under
section 4, EPA must show that the chemical persists and that
people are exposed to the chemical.
EPA argued that the plain language of section 4(a)(l)(b)
gives EPA authority to test chemicals in the absence of
information indicating that the substance is hazardous. Further,
EPA argued that it has authority to require testing of chemicals
produced in substantial quantities when either there is or may be
substantial release to the environment of such chemical or there
is or may be substantial or significant human exposure to the
chemical.
In the case of cumene, EPA found substantial production
along with substantial release and potential substantial human
exposure to cumene. EPA argued that it had substantial evidence
to support its findings based upon a production volume of 4.5
billion pounds per year, annual releases to the environment of 3
million pounds each year, and exposure to 790 workers (as
provided by a CMA survey) along with potential exposure to 13.5
million people who live in the vicinity of cumene manufacturing
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and processing facilities. At the end of fiscal year 1989, the
parties were awaiting a decision in this case.
Safe Buildings Alliance (SBA) v. EPA 846 F.2d 79 (D.C. Cir.
1988): The D.C. Court of Appeals upheld EPA's asbestos-in-
schools rules issued under the AHERA. The rules had been
challenged by SBA — an association of companies that formerly
manufactured asbestos products. The court extended substantial
deference to EPA, holding that the agency's rules were reasonable
in light of the somewhat contradictory demands of AHERA, the
uncertainties regarding the health effects of low-level asbestos
exposure, and the tight timetable AHERA imposed on EPA to issue
regulations.
In August 1988, National Gypsum Company, one of the
petitioners before the Court of Appeals, filed a petition for
certiorari before the Supreme Court. The briefs on this petition
by both National Gypsum and EPA essentially repeated the
arguments made before the Court of Appeals.
The Supreme Court denied certiorari in November 1989.
Chemical Manufacturers Association (CMA) v. EPA (No. 89-1153,
D.C. Cir.): CMA filed a petition for review of the CAIR which
EPA issued pursuant to TSCA section 8(a). CAIR establishes a
general framework for detailed reporting on chemicals by their
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manufacturers (including importers) and processors. As initially
promulgated, CAIR requires the submission of information for 19
chemicals. EPA intends to conduct future rulemakings to require
reporting on other chemicals as the need arises.
On July 19, 1989, EPA issued a request for additional
comments on certain revisions to the CAIR rule in response to
comment and concerns raised by CMA and other industrial groups.
EPA is seeking a stay of the briefing schedule in this case
pending the outcome of any rulemaking process to revise the CAIR
rule.
Corrosion Proof Fittings, et al. v. EPA and consolidated cases
(No. 89-4596, 5th Cir.): Petitioners brought this action to seek
review of EPA's final rule under TSCA section 6(a) banning future
manufacture, importation, processing, and distribution in
commerce of asbestos in almost all products. Eight petitions for
review have been filed in various circuits of the U.S. Court of
Appeals challenging the same rule. Several of these petitions
have already been transferred to the 5th Circuit where they have
been consolidated with Corrosion Proof Fittings. The remaining
petitions have motions to transfer pending before the appropriate
circuit. Issues and a briefing schedule will be developed over
the next few months.
Colorado Department of Institutions v. EPA (No. 89—1631, D.
Colo.): The Colorado Legislature enacted a law in its 1989
140
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session declaring the schools in the state Department of
Institutions exempt from the requirements Of the Asbestos Hazard
Emergency Response Act (AHERA)'. EPA officials indicated to state
officials that the agency believed the law did not create a valid
exemption. On September 20, 1989, the department requested the
federal district court to restrain EPA from inspecting or
otherwise interfering with the operation of its schools.
Arguments are expected to be presented to the court early in
fiscal year 1990.
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APPENDIX I
Summary of Research and Development Activities
Fiscal 1989 Accomplishments
A. TEST METHODS DEVELOPMENT
ENVIRONMENTAL PROCESSES
Report on neoplasms induced by methylazopyrmethanal
acetate in the Guppy Poecilia reticulata (9/89).
Report on carcinogenicity of the widely used
herbicide alachlor in freshwater and marine fish
(9/89).
Report on preliminary assessment of using Mekada
for predicting the carcinogenic potential of
chemicals (3/89).
HEALTH
A critical appraisal of the Functional
Observational Battery (FOB) and Motor Activity (MA)
as a screen for acute neurotoxicity (9/89).
B. HEALTH: MARKERS, DOSIMETRY, EXTRAPOLATION
Interim report on a database of initiatives,
promoters and noncarcinogens; in vivo biochemical
studies of halogenated hydrocarbons (11/88).
Annual report for fiscal 1988 on markers and
dosimetry research activities for exposure
monitoring (12/88).
C. SPECIAL HUMAN DATA NEEDS
Development of methodology for the use of
biochemical markers in epidemiology studies (9/89)
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D. ECOLOGY: TRANSPORT, FATE AND FIELD VALIDATION
EIWIRnMMF.TXfTAL PROCESSES
Report on role of co-metabolism in the
bi©degradation of xenobiotic chemicals (4/89).
Report on problems associated with published
environmental fate constants (3/89).
Report on EXAMS subroutines for predicting
microbial transformation rates of aquatic
pollutants by attached populations (7/89).
Report on comparative sensitivity of larval stages
of pelagic spawning estuarine fishes to toxic
substances (7/89).
Report on an evaluation of cluster analysis
techniques for determining community level effects
(9/89).
Report on physical scale effects of laboratory
microcosms in assessment of benthic macro-
invertebrate community structure (9/89).
E. ENGINEERING
Report on the fate of C. I. Disperse Blue 79 in
aerobic and anaerobic treatment systems (6/89).
F. EXPOSURE MONITORING
Interim report on human exposure model development
(Benzene) (1/89).
G. STRUCTURE-ACTIVITY RELATIONSHIPS
HEALTH
Summary report for HERL-OTS collaborative SAR
research on relevant classes of chemicals (9/89).
ENVIRONMENTAL PROCESSES
Report on current use of SAR for predicting
biotransformation of chemicals (8/89).
Report on mechanisms - specific QSAR models for
fathead minnow acute and chronic toxicity (5/89).
Unified QSAR strategy for predictive ecotoxicology
and initial environmental risk assessments (7/89).
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H. BIOTECHNOLOGY
ENVIRONMENTAL PROCESSES
Review of progress in Biotechnology/MPCA assessment
program (5/89).
HEALTH
Design and evaluation of animal models to study
potential health effects related to exposure to
pollutant-degrading microorganisms (2/89).
ENGINEERING
Assessment of potential for worker exposure to GEMS
in large-scale processing facilities (10/88).
Assessment of treatment technologies for
wastewaters from large-scale PMN processing
facilities (9/89).
I. ECOLOGY: ECOTOXICITY AND RISK ASSESSMENT
ENVIRONMENTAL PROCESSES
Report on maintenance and updating of PHYTOTOX
database for support of ecological risk assessments
(12/88).
Report on relative uncertainty of loading vs. other
components of toxic substances models (8/89).
Report on comparison of laboratory microcosms and
natural pond responses to Dursban (1/89).
Internal report on products of the Ecorisk Research
Program (5/89).
J. SUPPORT
MONITORING
Report on instrument spectra database development
(12/88).
Report on fiscal 1988 asbestos quality research
activities (9/89).
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PROCESSES
Support consists of providing technical and
scientific judgments and assessments through
scientific expertise or peer assessments; review of
test rule documents; validation of toxicity tests;
support for exposure and risk assessments; updating
TSCA testing guidelines; involvement in new
chemical (TSCA section 5, PMN) , existing chemical
and EPCRA program activities and through conducting
special reviews, workshops and demonstrations that
provide information and tools for generating and
enhancing regulatory and managerial decisions.
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APPENDIX J
Major TSCA-Related Reports Published in Fiscal 1989
TSCA Report to Congress
FY87 and FY88
Toxic and Hazardous
Substances
Preliminary Evaluations
of Initial TSCA Section
8(e) Substantial Risk
Notices Jan. 1987 -
Dec. 1988
Toxic Chemical Release
Inventory Risk Screening
Guide. Volume I The
Process. Volume II
Appendices
Chemical Releases and
Chemical Risk
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Environmental Assessment
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Environmental Assessment
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Environmental Assessment
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Existing Chemical Assess-
ment Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Existing Chemical Assess-
ment Division, Washington, D.C.
EPA NO. fNTIS NO.)
EPA560/1-89-001
EPA560/1-89-002
EPA560/2-89-001
(PB89 182 687/AS)
EPA560/2-89-002)
(PB90 122 128/AS)
EPA560/2-89-003
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EPA NO. CNTIS NO.)
Title III List of List
(Disk Version) Revised
Dec. 1988
Toxic Chemical Release
Inventory Reporting
Form R and Instructions
(Revised 1988 version)
Jan. 1989
Compliance Package
Toxic Chemical Release
Inventory Questions and
Answers
Supplier Notification
Requirements: Under
Section 313 of the
Emergency Planning and
Community Right-to-Know
Act. Requirements
Effective January 1,
1989
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C.
EPA560/4-88-003
(PB89 158 653)
EPA560/4-88-005
(PB89 164 248)
EPA560/4-89-001
EPA560/4-89-002
(PB89 164 255/AS)
EPA560/4-89-003
(PB89 192 892)
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EPA NO. (NTIS NO.)
Common Synonyms for
Chemicals Listed Under
Section 313 of the
Emergency Planning and
Community Right-to-Know
Act. Dec. 1988
Toxics-Release Inventory:
A National Perspective
Toxic Chemical Release
Inventory: A National
Perspective, Executive
Summary
Guidelines for Conducting
the AHERA TEM Clearance
Test to Determine
Completion of an
Asbestos Abatement
Proj ect
Dioxins and Dibenzo-
furans in Adipose Tissue
or U.S. Vietnam Veterans
and Control
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C. GPO 055-000-
0290-8 $14.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Economics and Technology
Division, Washington, D.C. GPO 055-000-
0289-4 $1.50
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
EPA560/4-89-004
(PB89 168 843)
EPA560/4-89-005
(PB89 208 144)
EPA560/4-89-006
(PB89 208 151)
EPA560/5-89-001
EPA560/5-89-002
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EPA NO. (HTIS NQ.l
Identification of SARA
Compounds in Adipose
Tissue. Final Report
Comparison of Airborne
Asbestos Levels
Determined by Trans-
mission Electron Micro-
scopy (TME) Using Direct
and Indirect Transfer
Techniques
Determination of
Reaction of the Gas-Phase
in the Troposphere.
Theory and Practice.
Part I. Hierarchal
Test Scheme
Determination of Rates
of Reaction in the Gas-
Phase in the Troposphere-
Theory and practices.
Part II. Rate of Direct
Photoreaction: Screening-
Level Test
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
EPA560/5-89-003
(PB90 132 564/AS)
EPA560/5-89-004
EPA560/5-89-005
EPA560/5-89-006
(PB90 143 165/AS)
EPA560/5-89-007
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File Update of Six
Interrelated Files of
the Environmental Fate
dataBase (EFDB): Biodeg
File Update of Six Inter-
related Files of the
Environmental Fate Data-
Base (EFDB): Biolog
File Update of Six Inter-
related Files of the
Environmental Fate data-
Base (EFDB): CASLST
File Update of Six Inter-
related Files of the
Environmental Fate
DataBase (EFDB):
Chemfate
File Update of Six Inter-
related Files of the
Environmental Fate
Data Base (EFDB):
Datalog
File Update of Six Inter-
related Files of the
Environmental Fate
Data Base (EFDB): Xref
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Exposure Evaluation
Division, Washington, D.C.
EPA NO. (NTIS NO.)
EPA560/5-89-008A
EPA560/5-89-008B
EPA560/5-89-008C
EPA560/5-89-008D
EPA560/5-89-008E
EPA560/5-89-008F
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EPA NO. (NTIS NO.)
Fish Toxicity Screening
Data. Part I. Lethal
Effects of 964 Chemicals
upon Steelhead Trout
and Bridgelip Sucker
Fish Toxicity Screening
Data. Part II. Lethal
Effects of 2,014 Chemicals
Upon Sockeye Salmon,
Steelhead Trout and
Threespine Stickleback
Summary of the EPA Work-
shop on Carcinogenesis
Bioassay Via the Dermal
Route
Summary of the Second EPA
Workshop on Carcinogenesis
Bioassay Via the Dermal
Route
Toxic Substances Control
Act (TSCA) Test
Submissions Database
(TSCATS) Comprehensive
Quarterly Update Tape
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Health and Environmental
Review Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Health and Environmental
Review Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Health and Environmental
Review Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Health and Environmental
Review Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Information Management
Division, Washington, D.C.
EPA560/6-89-001
(PB89 156 715/AS)
EPA560/6-89-001
(PB89 156 715/AS)
EPA560/6-89-002
(PB90 146 309/AS)
EPA560/6-89-003
(PB90 146 358/AS)
EPA560/7-89-012A-D
(PB88 912 900)
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EPA NO. (NTIS NO.)
Toxic Substances Control
Act (TSCA) Test
Submissions Database
(TSCATS) Quarterly
Update (microfiche)
Reporting Facility, Name
and Address
1987 Toxic Release
Inventory (mag. tape)
Office of Toxic
Substances Scientific
and Technical Reports:
1983-1988 (update)
Toxic Substances Control
Act. (TSCA) Chemical
Substances Inventory
Reissued Preferred Name
File, May 1989 Reissued
Synonym File
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Information Management
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Information Management
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Information Management
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Information Management
Division, Washington, D.C.
U.S. Environmental Protection Agency,
Office of Pesticides and Toxic
Substances, Information Management
Division, Washington, D.C.
EPA560/7-89-011A-D
EPA560/7-89-001
EPA560/7-89-002
EPA560/7-89-003
EPA560/7-89-004A-B
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