o-EPA
United States
Environmental Protection
Agency
Washington, DC 20460
OPA 100/0
July 1980
Administration
of the
Toxic Substances
Control Act (1979)
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Contents
Introduction 1
Highlights of 1979 Progress 1
Summary/Guide to Required Information 2
TSCA Chemical Substances Inventory 4
Reporting and Recordkeeping 5
Data Systems 6
Data Security and Disclosure 8
Premanufacture Notification 9
Testing 10
Risk Assessment 11
Control Actions T2
PoJychlorinated biphenyls (PCBs) 12
Asbestos 12
Chlorofluorocarbons (CFCs) 13
Hazard Warning Labels 13
Enforcement 15
Research 16
Coordination 17
Interagency Regulatory Liaison Group (IRLG) 17
Integration of Toxics Information 17
International Cooperation 18
State Cooperative Agreements 19
Public Participation 20
Financial Compensation 20
Grants 20
Advisory Committee 20
Industry Assistance 21
Regional Offices 22
Work Force 23
• Litigation 24
Problems 26
s, Appendix A (TSCA 1979: Principal Rules,
Regulations, and Public Notices Published
in the Federal Register) 27
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Introduction
This is the Annual Report on the
Environmental Protection Agency's
(EPA) administration of the Toxic
Substances Control Act (TSCA) for the
year 1979. This report addresses the
information required in sections 30,
28(c), and 9(d) to be reported annually
to the President and the Congress, as
well as additional information
concerning the Agency's
implementation of the Act.
Highlights of 1979
Progress
In the last 12 months, actions were
taken on all major TSCA provisions,
including those dealing with reporting
and recordkeeping, premanufacture
notification, testing, and chemical
control.
Reporting and recordkeeping. On
June 1, 1979, the Agency published
the initial Chemical Substances
Inventory. It lists over 44,000
commercial chemical substances used
in the United States that were
reported by their manufacturers or
importers. On October 31, the
Inventory's first supplement added
3,000 more chemicals to this listing.
Other information reported to EPA by
the chemical industry during the
1978 Inventory reporting period
included production volume estimates
and plant locations. A computer
system to enable the Agency to make
effective use of this important
information is partially complete. In
cooperation with other Federal
agencies, EPA has also begun to
develop a network to link existing
chemical data systems of the Federal
Government. This will facilitate public
access to this information. Strict
security procedures adopted by EPA
in 1978 were further improved in
1979 to prevent unauthorized
disclosure of confidential business
information. Approximately one-third
of the reports submitted for the
Inventory had one or more
confidentiality claims; production
volume was the item most frequently
claimed confidential.
Over 40 substantial risk notices for
chemical substances were received in
1979. More than 300 substantial risk
notifications have now been received
and acted upon by the Agency since
1977.
The Agency received substantial
information in response to the July
1978 rule requiring submission of
unpublished health and safety studies
on the first chemicals recommended
by the Interagency Testing Committee
for priority testing. After a lawsuit
was filed, challenging the validity of
the rule, the Agency voluntarily
revoked the rule in January 1979. On
December 31, 1979, EPA proposed a
new section 8(d) rule to exercise
essentially the same authority as the
revoked rule, although substantial
new issues have been raised.
Premanufacture notification. On July
1, 1979, the premanufacture
notification program began for manu-
facturers and bulk importers of new
chemical substances (those not listed
on the Inventory). Interim compliance
procedures for this program, required
by statute to begin one month after
the Inventory's publication, were
published on May 15, 1979. A portion
of the January 10, 1979, proposed
premanufacture notification
regulations was reproposed on
October 16, 1979. EPA plans to
finalize these regulations in the fall of
1980, once public comments have
been received and evaluated on the
required economic impact assessment
for this program.
Thirty-seven premanufacture notices
were received in 1979, covering a
total of 40 new chemicals.
Testing. On May 9, 1979, the Agency
proposed test standards for oncogenic
(tumor-forming), non-oncogenic
chronic, and combined oncogenic and
non-oncogenic chronic health effects.
In addition, on July 26, 1979, test
standards were proposed for
mutagenic effects, teratogenic and
reproductive effects, general
metabolism testing, and a variety of
acute and subchronic toxicity studies.
Good laboratory practices for each of
these standards also were proposed.
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Progress is underway on developing
test standards for a number of
environmental toxicity and chemical
fate characteristics, along with good
laboratory practices for each. These
standards will be proposed in 1980.
These generic test standards when
promulgated will be incorporated by
reference into test rules for specific
chemicals. The first rule for specific
chemicals or categories of substances
will be proposed in the first months of
1980.
By the close of 1979, 38 chemicals
and categories of chemicals had been
recommended for testing by the
section 4(e) Interagency Testing
Committee.
Chemical Control, On May 31, 1979,
the final ban rule for polychlorinated
biphenyls (PCBs) was issued. This
rule banned the manufacture,
processing, distribution, and non-
totally enclosed use of PCBs after
July 1, 1979. The May 1979 rule also
reduced the minimum PCB
concentration in materials covered by
both the ban and the 1978 marking
and disposal rules from 500 parts per
million (ppm) to 50 ppm.
Due to mounting evidence that
exposure to asbestos fibers can cause
lung damage and several types of
cancer, EPA initiated a nationwide
technical assistance program in
March 1979 to help States and school
districts identify school buildings
where deteriorating asbestos material
should be removed or sealed.
In addition, EPA published an
Advanced Notice of Proposed Rule-
making (ANPRM) on October 17,
1979, which discussed evidence that
exposure to asbestos in mining,
milling, and processing presents
serious health risks. The notice
revealed the Agency's preliminary
strategy for developing rules to
control unreasonable asbestos risks,
and asked for comments on several
issues and information needs.
EPA continued to investigate the
feasibility of controlling non-aerosol
applications of chlorofluorocarbons
(CFCs); a decision will be made in
early 1980. In March 1978 the
Agency, acting jointly with the Food
and Drug Administration and the
Consumer Product Safety
Commission, banned all non-essential
uses of CFCs in aerosol propellants.
The Agency began to work with the
Occupational Safety and Health
Administration to develop proposed
rules, that would require warning
labels-on chemical substances and
mixtures that pose acute or chronic
(cancer) hazards to workers
manufacturing or handling them.
Summary/Guide to
Required Information
Sections 30, 28(c), and 9(d) of TSCA
require that certain information be
reported each year to the President
and Congress. To assist readers in
locating this information, a summary
of each pertinent TSCA action and a
reference to a more detailed
explanation, within this report, is
given here.
Section 30. This section contains the
basic requirement for an Annual
Report and requests the following
information:
Testing required under section 4—No
testing rules for specific chemicals
have yet been proposed. However,
test standards and good laboratory
practices for health effects testing
were proposed during 1979. These
generic standards, when promulgated,
will be incorporated by reference into
test rules for specific chemicals.
Thirty-eight chemicals and categories
of chemicals have been recommended
for testing under TSCA by the
Interagency Testing Committee. See
the section on "Testing" for additional
details.
Premanufacture notices received—
The premanufacture notification
program for manufacturers and
importers of new chemicals began on
July 1, 1979. Premanufacture notices
for 37 new chemicals have been
received and reviewed; one chemical
is to be referred for follow-up action.
See the section on "Premanufacture
Notification" for additional
information.
Rules issued under section 6—Final
rules banning the manufacture,
processing, distribution, and non-
tot ally enclosed use of polychlorinated
biphenyls (PCBs) were published on
May 31, 1979, and became effective
on July 1, 1979.
An ANPRM concerning asbestos-
containing materials in schools was
issued on September 20, 1979. This
action announced the Agency's intent
to require, by rule, that schools be
surveyed for deteriorating asbestos
materials, and, where necessary,
require the removal or reduction of
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asbestos risks found. Another ANPRM
was published on October 17, 1979,
to discuss the Agency's strategy for
developing rules to control
unreasonable health risks in mining,
milling, processing, and use of
asbestos and asbestos-containing
materials.
A proposed rule is being written to
require workplace hazard warning
labels for chemical substances and
mixtures that pose acute or cancer
hazards.
Investigation continues on the
feasibility of controlling non-aerosol
applications of chlorofluorocarbons
(CFCs); a decision is expected during the
first half of 1980. See the section on
"Control Action" for additional
information.
Judicial actions under TSCA and
administrative actions under section
16—Six suits were brought: three
involved PCBs; one involved asbestos-
containing materials in school
buildings; one raised issues under
section 4; and another concerned a
rule promulgated under section 8(d).
See the section on "Litigation" for
additional information.
Several enforcement actions resulting
in civil penalties have been taken;
most were violations of PCB control
and marking/disposal rules. See the
section on "Enforcement" for
additional information.
Problems encountered in TSCA
implementation—See the section on
"Problems" for a brief discussion of
administrative and policy problems.
Recommended legislation—No
legislative changes are sought at this
time.
Section 28(c). This section requires a
report on grants to States during the
year. In April 1979 grants were
awarded to Maryland, Michigan, New
Jersey, New York and Wisconsin to
prevent or eliminate unreasonable
risks associated with chemicals for
which EPA is unable, or unlikely, to
take action under TSCA. See the
section on "State Cooperative
Agreements" for additional
information.
Section 9(d). This section requires
that EPA's efforts to coordinate its
TSCA activities with related activities
of other Federal agencies be reported
annually. This information appears in
the section on "Coordination", and,
as appropriate, in other sections of
this report.
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TSCA Chemical
Substances
Inventory
The initial TSCA Chemical Substances
Inventory, required under section 8(b)
of the Act, was published in four
volumes on June 1, 1979; a first
supplement followed on October 31,
1979.
Volume I lists 43,278 unique
chemical substances and their
Chemical Abstract Service (CAS)
Registry numbers, as well as 363
generic name substances whose
specific identities were claimed
confidential by the submitting
chemical manufacturers and
importers. The remaining three
volumes are access guides to the
actual inventory: Volumes II and III
comprise the Substance Name Index,
in which preferred names and various
synonyms are listed alphabetically.
Volume IV contains the Molecular
Formula and UVCB (unknown or
variable composition, complex
reaction projects or biological
materials) Indices. In addition to the
four-volume Inventory, EPA published
a two-volume Trademark and Product
Name List. This listing is not part of
the initial Inventory, and was a one-
time publication compiled solely to
help chemical processors determine
whether a chemical substance was
listed on the Inventory.
The supplement added 3,000
substances to the initial Inventory. A
second supplement is planned for
February 1980, and a final revised
Chemical Substances Inventory is to
be published in July 1980.
In compiling the Inventory, the
Agency also received 1977 production
volumes (in broad ranges) and manu-
facturing sites of each chemical
(small companies did not have to
submit these data). To facilitate
access to this information, it has been
fully computerized. An example is the
Regional Chemical Information
Directory which lists the Inventory
chemical production information
within each of the ten separate areas
of EPA's Regional Offices.
A portion of the site-specific data was
claimed confidential. However, 68
percent of the total information
submitted for the Inventory was not
claimed as confidential. Production
volume was the item most frequently
claimed confidential. EPA is
examining ways of summarizing these
data to provide the public with a
general but meaningful picture of
commercial chemical manufacturing
in the United States.
With publication of the initial
Inventory, a second reporting period
of 210 days began (June 1 -
December 31, 1979). It allowed
processors and users of chemical
substances (as well as importers of
chemical substances as part of
mixtures or articles) to report
substances not included on the initial
Inventory. Thus, processors and users
had an opportunity to insure that
substances that actually were in
commerce in 1977 appear on the
Inventory, even though they may not
have been reported by a manufacturer
or importer. The processors' input will
appear in the revised Inventory
edition to be published in 1980. Any
substance not included in the
Inventory will be considered "new"
under TSCA, and thus subject to
EPA's premanufacture notification
program before it can legally be
manufactured, processed, or
imported.
Due to the two-phase reporting
period, the published Inventory
temporarily will not include all the
reported substances. Consequently, a
Master Inventory File, in a computer-
based information system, is
maintained by the Agency for
immediate access to submitted data.
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Reporting and
Recordkeeping
Section 8 of TSCA empowers EPA to
obtain various kinds of information
from chemical manufacturers and
processors and, in many instances,
distributors. This can include
information on mixture composition,
byproducts, impurities, uses,
exposures, and toxicity. EPA's first
use of the section 8 authority was the
December 1977 publication of the
reporting rules for the TSCA Chemical
Substances Inventory; since then,
several activities have been initiated
under this portion of TSCA.
Under section 8(a), EPA is developing
a set of reporting rules to support its
comprehensive chemical risk
assessment program. The first
proposed rule, called the "Preliminary
Assessment Information Rule," will
be proposed early in 1980; an
Advanced Notice of Proposed
Rulemaking (ANPRM) for this rule
was published on June 27, 1979.
Two other proposed rules will follow
later in the year. The first rule will
apply to about 2,300 chemicals and
will collect general exposure
information for initial priority-setting
and risk evaluation. The second and
third rules will progressively apply to
fewer chemicals and will collect the
detailed data needed to decide
whether to regulate or require testing
of the chemical. The rules requiring
more detailed data will provide useful
information for other Federal
agencies, as well as EPA.
Section 8(a)(3) requires the
Administrator to exclude, by rule,
small manufacturers and processors
from most recordkeeping and
reporting requirements under section
8(a). To date, EPA has developed
several small business exclusion
criteria for separate section 8(a) rules.
To provide consistency and to
alleviate the cumulative burden of
these rules, EPA is developing generic
small business exclusion standards to
apply to all section 8(a) rules. These
standards will be published for
comment in 1980.
An ANPRM published on October 17,
1979, announced that the Agency is
investigating the regulation of
commercial and industrial uses of
asbestos fibers under section 6. In
addition, the ANPRM described that a
section 8(a) rule is being developed to
obtain asbestos information not
otherwise available for this regulatory
process. The section 8(a) rule is
expected to be proposed in the spring
of 1980.
Also under section 8(a), the PBB
(polybrominated biphenyls)/Tris (Tris-
2,3 dibromopropyl phosphate) Notice
Rule was proposed on October 12,
1979. This rule would require
manufacturers and importers of PBBs
or Tris to notify the Agency if they
either are or intend to manufacture or
import these substances. The notice
would contain information on use,
production volumes, byproducts, and
worker exposure.
Another section 8(a) rule to be
proposed in early 1980 will require
reports on the composition of
chemical trade name products. The
rule will obtain information needed to
assign specific names to chemical
substances reported for the Chemical
Substances Inventory and under
premanufacture notice requirements
that result from reactions involving
trade name chemical products. To
reduce the regulatory burden, the
Agency requested, by letter, that
manufacturers of trade name reactant
products voluntarily submit the
information. Those that comply will
not be subject to this section 8(a)
rulemaking.
A proposed amendment to the
December 1977 Inventory reporting
rules, published on October 22, 1979,
established a January 1, 1983,
deadline for maintaining records
supporting the initial Chemical
Substances Inventory reporting.
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Section 8(c) authorizes the Agency to
require manufacturers, processors,
and distributors to maintain and
submit information on allegations of
adverse health and environmental
effects of chemicals. EPA is
developing a rule to require that this
information be maintained and, under
pre-specified conditions, submitted to
the Agency. EPA is attempting to
coordinate this proposal with similar
rules established by the Consumer
Product Safety Commission and the
Occupational Safety and Health
Administration. The Agency expects
to propose the rule for public
comment in early 1980.
Under section 8(d), the Agency can
require the submittal of health and
safety studies. EPA's first section 8(d)
rule, issued in July 1978, required
the reporting of unpublished studies
about chemicals recommended for
priority testing consideration by the
TSCA Interagency Testing Committee.
EPA issued the rule to obtain health
and safety data to help determine
whether to require the testing the
Committee had recommended. In
January 1979, after receiving the
information sought by the Agency,
EPA voluntarily revoked the rule. On
December 31,1979, the Agency
proposed a new section 8(d) rule
which considered issues raised in the
initial rulemaking, as well as
substantial new issues.
Under section 8(e), chemical manu-
facturers, processors, and distributors
are required to report information
suggesting that a chemical substance
or mixture presents a substantial risk
of injury to health or the environment.
To date, the Agency has received
more than 320 substantial risk
notifications; 48 of these were
submitted in 1979. A few prompted
the Agency to include chemicals in
the TSCA risk assessment process.
Several contained information of
possible interest to other Federal
agencies, particularly the
Occupational Safety and Health
Administration and the National
Institute for Occupational Safety and
Health; this information has been
transmitted. Still others contained
data already known to the Agency or
that did not predict significant
implications for human health or the
environment. All section 8(e) notices
are carefully reviewed and a report
prepared on each is placed in the
public file.
Other related reporting and
recordkeeping authorities include
sections 12, 13 and 20. Section 12(b)
requires persons exporting or
intending to export a chemical
substance or mixture subject to
certain TSCA actions (sections 4, 5, 6,
or 7) to notify EPA. The Agency in
turn must notify the importing country
of the EPA regulatory action. On
October 2, 1979, the Agency
proposed a section 12(b) rule to
govern submission of these notices to
EPA. The proposed procedures were
effective immediately as interim
guidance for notices of PCB and CFC
exports.
Section 13 requires the Secretary of
the Treasury to refuse entry of any
chemical substance into the United
States if it violates a TSCA rule. EPA
is consulting with the United States
Customs Service on the development
of this rule. The Agency held public
meetings to discuss the importation of
TSCA-regulated substances in late
1979. The proposed rule will be
published in early 1980.
Section 20 authorizes any person to
take civil action against violators of
TSCA section 4, 5, or 6 rules. It also
authorizes civil actions against EPA to
compel performance on any non-
discretionary act or duty under TSCA.
EPA will develop a rule for plaintiff
procedures in order that the Agency,
or any alleged violator, may have 60
days notice of civil action intentions.
This rule should be published for
comment early in 1980.
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Data Systems
In accordance with section 10(b) of
the Act, EPA is developing computer-
based data systems to collect, store,
retrieve, analyze and disseminate
information submitted to EPA under
TSCA, and other relevant toxicological
and scientific data.
EPA has developed the Chemicals in
Commerce Information System (CICIS)
to store and retrieve TSCA data. This
system contains TSCA confidential
business information and reflects
state-of-the-art computer security
techniques. The system's modules
represent functional TSCA activities.
The first module, the TSCA Inventory,
became operational in late 1979, and
several information services have
been derived from it, including
subsystems for Freedom of
Information Act requests and the
Inventory profiles for EPA Regional
Offices mentioned earlier. Other
current CICIS modules support the
TSCA premanufacture review process
and manage health and safety study
submissions.
The Interagency Toxic Substances
Data Committee (ITSDC), formed in
February 1978 by EPA and the
Council on Environmental Quality, is
continuing its work to construct a
comprehensive Chemical Substances
Information Network (CSIN).
Members of ITSDC include the
Department of Health, Education, and
Welfare and several of its component
agencies, the Departments of Labor,
Commerce, Agriculture, Interior,
Defense, Transportation, State, and
Energy, the Consumer Product Safety
Commission, and the National
Science Foundation.
CSIN will enable toxic substances
information users to have access to a
number of data banks, inlcuding
CICIS. Initial components of CSIN will
include: a Chemical Information
Resources Directory (CIRD) to direct
users'to particular data banks that
will meet their needs; a Chemical
Substances Nomenclature System
(CSNS) to identify about 1,000,000
substances and direct users to other
files containing information on
particular substances; a Toxicology
Data Management System (TDMS) to
store and retrieve data from chemical
testing; a Laboratory Animal Data
Bank (LADB) for information on
laboratory animal strains to be used
in designing testing programs; and a
Chemical Regulations and Guidelines
System (CRGS) for information on
chemical standards, regulations, and
guidelines.
EPA administers CSIN, which will be
in partial operation early in 1980.
CSIN will significantly advance
making chemical data readily
available to both governmental and
non-governmental organizations.
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Data Security
and Disclosure
To protect confidential business
information submitted under TSCA
from unauthorized disclosure, EPA
published the TSCA Confidential
Business Information (CBI) Security
Manual in July 1978. The manual
inlcudes procedures for physical
security, custody, access, and
computer processing.
The 1978 manual is being revised to
reflect experience gained through the
handling of CBI submitted in response
to rules or regulations promulgated
under TSCA. The revised security
manual will continue to protect TSCA
CBI from unauthorized disclosure, but
will provide greater operating
efficiency by streamlining procedures
for handling and gaining access to it.
The revised manual is scheduled for
publication in mid-1980. To
supplement the Agency's CBI
handling procedures, a training and
awareness program is in full
operation at EPA Headquarters and
throughout the Regional Offices.
Attendance is mandatory for all EPA
employees who are allowed access to
TSCA CBI.
With the expanding development and
growing use of computer systems to
store, control, and retrieve data
submitted under TSCA, particular
attention is being given to the
protection of TSCA CBI. Current
computer operations are continually
audited to insure that applicable
state-of-the-art security capabilities
are explored and utilized as new
systems are placed into operation.
In addition, mechanisms to segregate
confidential from non-confidential
data are in place, as well as methods
to provide EPA Headquarters and
Regional Offices access to non-
confidential information submitted
under TSCA. This accessability
facilitates timely responses to
Freedom of Information Act requests.
Various information dissemination
vehicles are being explored to make
non-confidential information more
readily available to the general public.
Initial negotiations with other Federal
agencies led to draft security plans
being developed for the transfer and
protection of TSCA CBI. After these
plans are approved by EPA,
Interagency Agreements for the
controlled exchange of confidential
information will be made in 1980.
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Premanufacture
Notification
Under section 5 of the Act, any
person who intends to manufacture
or import a new chemical substance
for commercial purposes in the United
States must submit a notice to EPA at
least 90 days prior to its manufacture
or importation. A "new chemical
substance" is one not included on the
Inventory of existing substances. The
requirements of section 5 became
effective July 1, 1979, under interim
guidance published in May 1979.
On January 10, 1979, EPA proposed
rules and notice forms for the
premanufacture notification (PMN)
program. Subsequently, due to the
number and nature of comments
received, the Agency decided to
repropose portions of the January 10
notice. The Agency published the
reproposal on October 16, 1979,
allowed a 45-day comment period,
and held public meetings with
representatives of the chemical
industry, public interest groups,
organized labor, and others. The
Agency expects to promulgate the
rules and forms in mid to late 1980.
EPA's objective in reproposing the
January 1979 rules and forms was to:
(1) obtain information to permit a
preliminary assessment or the risks
associated with the manufacture,
processing, distribution in commerce,
use and disposal of new chemical
substances; and (2) obtain this
information at minimum cost to
submitters. In revising the notice
forms, EPA considered the minimum
information and level of detail
necessary for such a preliminary
assessment, the likely availability of
such information, and the associated
costs.
Since January 1979, EPA has further
refined its process for reviewing
PMNs, including a more precise
definition of the minimum information
needed for each phase. The revised
form is designed to provide EPA with
enough information to: (1) select
some substances for more detailed
evaluation and for which additional
exposure or toxicological data are
needed; (2) identify some that will be
subject to requirements for follow-up
reporting concerning their commercial
development; (3) eliminate others
from further consideration; and (4)
select a limited number for immediate
regulatory attention.
Since the July 1, 1979, effective date
of the premanufacture program, EPA
has received 37 PMNs covering 40
new chemicals. Of those PMNs EPA
has reviewed, the Agency thus far
plans to refer one chemical for future
follow-up action; more are expected
in 1980.
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Testing
Section 4 of the Act authorizes rules
requiring manufacturers and/or
processors of chemical substances or
mixtures to test how these
substances affect human health and
the environment. The Act requires
that these testing rules include
standards specifying the procedures
to be used in conducting required
tests.
The Agency is developing a full range
of generic health and environmental
effects test standards to be
incorporated, by reference, into test
rules for specific chemicals. During
1979, the Agency proposed test
standards covering all major areas of
health effects, except neurotoxicity,
behavioral testing and behavioral
teratogenicity testing. In May,
proposed test standards were
published for oncogenic (tumor-
forming) effects, for non-oncogenic
chronic health effects, and for
combined oncogenic and non-
oncogenic chronic effects. Good
laboratory practices for health effects
testing were also proposed. In July,
test standards were proposed for
mutagenic effects, teratogenic and
reproductive effects, general
metabolism testing, and a variety of
acute and subchronic toxicity studies.
Substantial efforts have been made to
insure consistency, wherever
possible, between the TSCA test
standards and other Federal and
international testing guidelines. A
public meeting was held in October
1979 to receive comments on the
proposed health effects standards.
Development of test standards for
environmental effects is proceeding
rapidly. Standards for a number of
environmental toxicity and chemical
fate characteristics are expected to be
published in 1980, along with good
laboratory practice standards for
environmental effects testing.
Efforts to evaluate chemicals for
inclusion in section 4 testing rules
and to develop operating procedures
for implementing TSCA's testing
authority are a high priority. To date,
38 chemicals and categories of
chemicals have been recommended
by the TSCA Interagency Testing
Committee (ITC) for testing under
section 4. EPA responded within 12
months to each of the first two sets of
ITC recommendations, presenting the
Agency's reasons for not having
initiated rulemaking under section
4(a). However, a district court recently
held that EPA's response was
inadequate and ordered the Agency to
submit a compliance plan. The
Agency plans to propose the first
section 4 rule, requiring health effects
testing for several chemicals or
categories recommended by the ITC in
the Spring of 1980.
Section 4 also requires EPA to
establish procedures for exempting
manufacturers or processors whose
testing would duplicate that already
being performed, as well as a
procedure to set equitable
reimbursement by parties exempt to
the testing rules. Proposed exemption
procedures are being developed and
will be published with the first testing
rule. Reimbursement procedures were
the subject of an Advanced Notice of
Proposed Rulemaking published in
September 1979.
10
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Risk
Assessment
A necessary component of most TSCA
implementation activities is an
assessment of the nature and
magnitude of risks that chemicals
may present to human health or the
environment. Among other things,
risk assessment is an integral part of
the Agency's premanufacture review
of new chemicals, investigation and
regulation of existing chemicals in
commerce, selection of chemicals for
testing requirements, and evaluation
of substantial risk information
submitted under section 8(e).
Over 320 substantial risk notices
have been received by the Agency
since January 1, 1977; approximately
48 of these were received during
1979. Chemicals identified from this
and other sources are subject to a
multi-staged chemical assessment
process.
In the Agency's comprehensive
assessment process, large numbers of
chemicals undergo preliminary
assessments designed to select those
likely to present significant risks and
to identify those for which additional
information is needed. In each stage,
some chemicals will be chosen for
more intensive investigation;
ultimately, where it is apparent that
control action is needed, detailed risk
evaluations will be prepared. In this
process, efforts are made to identify
and assess the full range of adverse
effects and exposure sources of
possible significance to human health
and the environment. All components
of EPA's monitoring and
environmental survey program are in
place and operating to support TSCA
risk assessment actions.
A number of chemicals have already
undergone or are undergoing risk
assessment. Preliminary assessments
of more than 40 chemicals were
completed in 1979. About one-third of
these were selected for more detailed
assessment, possibly leading to
regulatory action in the future. Many
more were found to be of potential
concern but sufficient data on use,
exposure, and environmental release
to support decision-making are
lacking at this time. These chemicals
will be included in data gathering
efforts under section 8(a) of the Act
(described in the "Reporting and
Recordkeeping" section of this report).
In-depth assessment activities begun
last year on asbestos and
chlorofluorocarbons are continuing.
The in-depth assessment of
nitroacetic acid (NTA), also
commenced in 1978, has been
suspended pending re-evaluation of
the health effects data by the National
Toxicology Program.
In addition to assessments of
"existing" chemicals on the TSCA
Inventory, assessment of "new"
chemicals subject to the section 5
premanufacture notification program,
also began during 1979. (See the
"Premanufacture Notification" section
of this report for further details.)
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Control Actions
Pplychlorinated
Biphenyls (PCBs)
Section 6(e) of the Act requires EPA
to establish rules governing the
marking and disposal of PCBs, and to
prohibit, with certain exceptions, their
manufacture, processing, distribution
and non-totally enclosed use. The
marking and disposal rules were
issued in February 1978. In May
1979 a final rule banned the
manufacture, processing, distribution
and non-totally enclosed use of PCBs.
This rule also reduced from 500 parts
per million (ppm) to 50 ppm the
minimum PCB concentration in
materials covered by both regulations.
The Agency's marking rules require
that most PCB-containing items and
storage areas be marked. In general,
the disposal rules require high-
temperature incineration of all liquids
with greater than 500 ppm PCBs, and
the burial in chemical waste landfills
or destruction in high-efficiency
boilers for all other PCBs. For certain
large-volume materials sometimes
contaminated with PCBs, such as
dredge spoil and municipal sewage
sludge, alternative disposal methods
may be approved by EPA Regional
Administrators. All PCB disposal
facilities must meet certain technical
criteria; currently, eight chemical
waste landfills have been approved.
Applications for approval of high-
temperature incinerators are under
consideration; decisions are expected
in 1980.
The Agency's ban rules became
effective on July 1, 1979, with certain
exemptions. The Act allows EPA to
grant exemptions upon specific
request. To date, EPA has received
about 40 petitions for exemptions to
continue the manufacture of
chemicals in which PCBs are
produced as byproducts in most cases
at concentrations greater than 50
ppm, with the final products having
less than 50 ppm PCBs. EPA has also
received approximately 300 petitions
for exemptions from the processing
and distribution in commerce bans.
The ban rules published in May 1979
included EPA's proposed disposition
of the manufacturing petitions.
Hearings were held in July; final
disposition is expected in April 1980.
EPA estimates that approximately 750
million pounds of PCBs are still used
in transformers and capacitators.
Because of an incident involving the
PCB contamination of poultry feed
and the subsequent contamination of
large amounts of poultry, eggs and
egg products, EPA, in cooperation
with the Food and Drug
Administration and the Department of
Agriculture, has instituted a program
to inform the food, feed, fertilizer and
agricultural pesticide industries about
the special hazards of PCBs in these
kinds of establishments. The program
also will inform these industries of
methods for identifying, removing and
properly disposing of PCB-containing
equipment. The three agencies also
are gathering additional information
on the potential for future
contamination incidents. This
information may provide the basis for
future regulations.
Asbestos
Studies of humans and animals
provide evidence that exposure to
asbestos fibers, even at low
concentrations and for short time
periods, can result in lung damage
and several types of cancer. Because
asbestos is present in many products,
humans may be exposed in the
workplace, near asbestos processing
facilities, and through routine daily
activities. For many years, sprayed
asbestos-containing materials were
used inside buildings for fireproofing,
thermal and acoustical insulation, and
decorative purposes. These uses are
now prohibited under the Clean Air
Act because of resulting human
exposure from the spraying
operations.
Sprayed asbestos-containing material
in many buildings is deteriorating,
with the result that the occupants are
being exposed to asbestos fibers. An
undetermined, but probably large,
number of schools are among
structures where asbestos exposure
may be occurring. EPA has initiated a
nationwide technical assistance
program designed to help States and
school districts identify schools where
deteriorating asbestos-containing
material should be removed or sealed.
EPA has published a detailed
technical guidance package, and is
providing training and technical
assistance to State and local school
officials.
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The technical assistance program has
provided extensive information on the
proper analysis of bulk insulation
materials for asbestos. A week-long
training course in polarized
microscopy was conducted at each of
EPA's 10 Regional Offices during
1979. A standard analytical protocol
for the asbestos analysis of bulk
materials is currently being prepared
and field tested before being
distributed to participating
laboratories. A quality assurance
program to complement the issuance
of the standard protocol is underway
to monitor the sample analysis
provided by laboratories. Additional
activities include the preparation of a
photomicrographic particle atlas to
assist laboratories in the proper
identification of fibrous materials in
bulk samples.
EPA is concerned that participation in
this program may not sufficiently
reduce the health risk to people
exposed in schools, and is
determining whether rulemaking may
be necessary. To inform the public of
the Agency's concern, EPA published
an ANPRM. This Notice discussed
EPA's concern for protecting the
public, identified several issues that
needed resolution, and requested
public comment. EPA anticipates that
any developed rule would require
schools to be surveyed to determine if
they contain deteriorating asbestos
materials. If serious problems are
identified, action to reduce the risk,
such as removal of the asbestos,
would be required. Further, all
schools containing asbestos would
have to periodically re-evaluate the
condition of asbestos-containing
materials.
In addition to its uses in buildings,
asbestos still is used widely in several
thousand industrial and commercial
products. About 30 million tons has
been used in the United States this
century; and the total is increasing by
about 750,000 tons each year.
Because asbestos resists
decomposition, it can remain in the
biosphere for extremely long periods,
resulting in prolonged exposure to
humans. Therefore, EPA is concerned
that continuing the mining, milling,
processing, and use of asbestos and
asbestos-containing articles may
present unreasonable health risks.
EPA has begun an investigation of
potential human exposures during the
asbestos life cycle (i.e., exposures
occurring in mining, milling,
processing, fabrication of articles,
installation of products, use,
demolition, and disposal). This
investigation also will examine the
availability of substitute materials and
products, the benefits associated with
asbestos uses, and the socio-
economic impacts of various
alternatives for reducing human
exposures. From this investigation
EPA will propose rules to eliminate
unacceptable health risks including
the possibility of a complete, phased-
in ban of all non-essential uses of
asbestos. An ANPRM concerning this
investigation was published on
October 17, 1979, with an additional
notice extending the public comment
period and discussing a further option
published on December 17, 1979.
These Notices discussed evidence
that exposure to asbestos presents
serious health risks, EPA's strategy
for developing rules to control
unreasonable risks from asbestos,
and presented for comment several
issues and information needs.
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Chlorofluorocarbons
(CFCs)
In March 1978, acting jointly with the
Food and Drug Administration and the
Consumer Product Safety
Commission, EPA issued final rules
prohibiting the manufacture and
processing of Chlorofluorocarbons
(CFCs) as propellents in non-essential
aerosol applications.
During 1979, EPA continued to
encourage other nations to take
actions to control CFC emissions. EPA
also continued investigating the
desirability and feasibility of
controlling non-aerosol CFC
applications. Two other nations took
steps to control CFCs during 1979.
Norway banned non-medical aerosol
CFC uses, and the Netherlands
required the labeling of aerosol cans
containing CFCs. In addition, the
European Economic Community (EEC)
proposed a 30% reduction of CFC
aerosol uses from 1976 levels;
member nations are to achieve the
reduced levels by December 1981.
In December 1979 the National
Academy of Sciences (NAS) issued a
report, "Stratospheric Ozone
Depletion of Halocarbons: Chemistry
and Transport", showing that ozone
depletion is occurring twice as rapidly
as previously suspected. A 1976 NAS
report projected a steady-state
depletion rate of 7.5%; the 1979
report estimates a rate of 16.5% if
emissions continue at 1977 levels.
NAS will shortly release a second
report, entitled "Prevention of Ozone
Depletion by Chlorofluorocarbons",
discussing the health and
environmental effects of ozone
depletion. The report also will
examine alternatives to CFCs in non-
aerosol applications.
EPA is presently considering both
domestic CFC control methods and
strategies for further international
action. A decision on future EPA
actions will be based on the findings
of the two NAS reports, economic
analyses, and internal assessments of
health and environmental impacts.
The Agency's decision is expected by
the summer of 1980.
Hazard Warning
Rule
Over the past several months, EPA
has been working with the
Occupational Safety and Health
Administration (OSHA) to develop
proposed labeling rules for industrial
chemical substances and mixtures
distributed in U.S. commerce. The
proposed rules are being designed to
insure that industrial firms and their
employees have easy access to
information about the hazards of
chemical products they handle, thus
enabling them to alleviate associated
risks.
EPA's proposed rule is being written
to require hazard warning information
for chemical substances and mixtures
that pose acute (toxicity, irritation,
and flammability) or cancer hazards.
For acute hazards, EPA is considering
a labeling procedure based on an
industry consensus standard adopted
by the American National Standards
Institute. For cancer hazards, EPA
plans to require warnings for
chemicals known or believed to pose
human cancer risks based on
acceptable epidemiological studies or
animal testing.
EPA's proposal will complement
OSHA's, which is being written
primarily to require disclosure of the
identity of chemical substances and
mixtures. EPA's rule will be proposed
under section 6(a)(3) of TSCA, which
authorizes the Agency to require that
substances and mixtures "be marked
with or accompanied by clear and
adequate warnings and instructions."
The Agency would establish such
requirements only after considering
both the costs and benefits.
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Enforcement
During 1979, EPA conducted 679
inspections to monitor compliance
with the PCB rules and found
potential violations at 248 facilities.
These figures suggest that slightly
over one-third of those subject to the
rule may be in violation. Many of the
violationsj/vere minor and were
corrected in the inspector's presence;
others resulted in enforcement
actions being taken against firms; and
the remainder are still under
investigation.
A total of 56 enforcement actions
were initiated by EPA during 1979 for
alleged violations of the PCB rules.
Combined penalties of $72,000 were
assessed in the 12 civil administrative
cases now complete; 16 other cases
are still in administrative litigation.
Notices of noncompliance were
issued in 22 cases. In four cases civil
court actions were filed by the
Department of Justice to remedy
serious situations that posed risks to
health or the environment; two of
these have been completed.
Criminal prosecutions resulting from
the illegal disposal of PCBs along
North Carolina roadways continued in
1979. One defendant pleaded guilty
in January 1979; another was
expected to go on trial soon.
In addition to enforcing the PCB rules,
EPA also conducted inspections to
monitor compliance with section 8(b)
Inventory requirements and rules
banning non-essential uses of
chlorofluorocarbons. EPA also
completed several section 8(e)
substantial risk investigations.
Other enforcement activities included:
initiating a cooperative program with
the General Services Administration
to bring Federal facilities into
compliance with the PCB rule; and
developing strategies and program
guidance for enforcing existing and
proposed rules. EPA's toxics
enforcement efforts also led to the
development of the Consolidated
Rules of Practice Governing
Administrative Assessment of Civil
Penalties and Revocation or
Suspension of Permits, which
provides standard procedures for
administrative enforcement
proceedings under five EPA-
administered statutes. In addition, the
Agency led the development of
procedures for coordinating
enforcement activities with other
agencies in the Interagency
Regulatory Liaison Group.
is
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Research
EPA's Office of Research and
Development provides both short-term
technical assistance on specific
chemicals and longer-term research
for new techniques to evaluate and
control chemical hazards.
Agency researchers are working on
several screening methods for health
effects testing, with a focus on
behavioral toxicity and neurotoxicity.
Methods also are being developed to
determine if a chemical could cause
congenital abnormalities that would
not necessarily be apparent at birth.
In the environmental effects testing
area, EPA researchers are involved in
validating ecological effects testing
methods, and developing models to
simulate, for prediction purposes, the
fate and transport of chemicals in the
environment.
The Agency's premanufacture
notification program also is receiving
technical research support. Further,
EPA researchers are evaluating
materials that could be used to coat
and seal sprayed-on asbestos in
buildings, and are developing
analytical methods to assess the
exposure levels from asbestos-
containing materials.
In 1979, the Agency's Research and
Development and Toxic Substances
Program Offices established a joint
Research Committee on Chemical
Testing and Assessment. Other
Agency offices including Enforcement,
Planning and Management, and the
Regional Offices, also participate in
activities of the Committee. The
participants meet at least quarterly to
discuss research needs and priorities
for a toxics research program.
Subcommittees on Health Effects,
Environmental Fate and Effects, and
Monitoring have provided R&D
recommendations for 1980. The
Committee also will be drafting a
strategy for toxics research that spans
the next several years.
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Coordination
Interagency Regulatory
Liaison Group (IRLG)
The Interagency Regulatory Liaison
Group (IRLG) is a unique partnership
of Federal agencies involved in
regulating hazardous substances. Its
goals are to improve public health
through sharing information, avoiding
duplication of effort, and developing
consistent regulatory policies. The
IRLG consists of five Federal
agencies: EPA, the Consumer Product
Safety Commission, the Food and
Drug Administration, the
Occupational Safety and Health
Administration, and the Food Safety
and Quality Service. Other agencies
participate in relevant specific
projects.
One of the IRLG's major accomplish-
ments was the recent joint issuance
of a document dealing with the
scientific concepts and methods for
identifying and evaluating substances
alleged to pose a cancer risk. This
document served as the basis for the
Federal Regulatory Council's
"Statement of the Regulation of
Chemical Carcinogens," contributed
to CPSC's decision to withdraw its
similar proposed carcinogen policy,
and is providing a basis for other
government carcinogen policies. The
Statement also is expected to help
expedite individual regulatory
decisions.
The IRLG also is engaged in
developing testing guidelines
acceptable to all member agencies.
and has completed five draft health
effects testing guidelines that were
reviewed by the member agencies'
staffs and released for public
comment. The guidelines cover
testing for eye irritation, acute dermal
toxicity, acute inhalation toxicity,
acute oral toxicity, and teratogenicity.
Guidelines for an additional 12 health
effects and 9 environmental tests
have at least been partly drafted.
IRLG's work in this area should
reduce the chemical industry's testing
burdens by eliminating unnecessary
differences in methodological details
that otherwise would require testing
duplication.
IRLG has taken other significant steps
to coordinate member agencies' work
to develop rules and regulations
affecting chemical substances. New
regulatory coordinating groups were
formed on benzidene dyes and
chlorinated dioxins. A rulemaking
coordination model was the October
17, 1979, Advanced Notice of
Proposed Rulemaking on asbestos
commercial products, published by
EPA, at the same time the Consumer
Product Safety Commission released
a similar notice. Each of those notices
called for the sharing of data and
avoidance of duplication. In addition,
formal agreements were made with
other regulatory agencies for
conducting joint risk assessments,
sharing confidential business
information, and coordinating public
education on asbestos and PCB risks.
Numerous other IRLG coordination
projects in the areas of compliance
and enforcement activities, research,
data collection and dissemination, and
public information and education are
underway. Cooperative activities are
taking place at both Headquarters and
Regional Office levels.
Integration of
Toxics Information
In addition to coordinating control
action with other Federal agencies,
for chemicals of current interest, EPA
completed a data base and framework
for future chemical coordination
opportunities.
In June 1979, EPA published the
"Directory of Federal Coordination
Groups for Toxic Substances". This
Directory references Federal toxic
chemical coordinating groups (e.g.,
committees and task forces), and
enables better communication
between agencies and the groups
themselves. In early 1980,' an updated
edition of the Directory will be
published. Also planned for release in
spring 1980 is a second publication to
be entitled "Federal Toxic Substances
Programs—An Overview". This will
be an organizational reference to
Federal programs regulating, or
supporting the efforts of toxic
substances control, as well as provide
summaries of statutory authorities.
The "EPA Chemical Activities Status
Report" was another coordination
reference published in April 1979. It
catalogs, by chemical, the completed
and on-going assessment work and
control activities within EPA
programs. This document will be
expanded and revised in 1980.
A further example of non-regulatory
chemical integration was the EPA-
wide work group on chlorinated
dioxins. This group coordinated
Agency policies on dioxin
assessments and evaluations,
sampling and analytical protocols, and
provided waste disposal guidance to
the EPA Regional Offices.
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International
Cooperation
In addition to the United States,
several European nations and Japan
are regulating commercial chemicals.
Recognizing the need to promote
effective international control of
chemical hazards, while avoiding
unnecessary trade barriers, EPA is
actively participating in international
efforts to harmonize various aspects
of several nations' regulatory
programs. EPA continues its lead role
in the Organization of Economic
Cooperation and Development (OECD)
Chemicals Program for harmonizing
international regulatory approaches in
the control of chemicals. The Agency
has the U.S. lead in coordinating
OECD Chemicals Group activities, and
participates in all six chemicals
testing expert groups, as well as the
groups addressing good laboratory
practices, confidentiality, and a
glossary of key terms.
In the interest of harmonization, EPA
discussed with the European
Community (EC) TSCA and the EC's
approach to regulating toxic
substances. The Agency is actively
sharing with foreign countries and
international bodies (e.g., through the
OECD and bilateral contacts with
Japan, Switzerland, Canada, Mexico
and the EC) information and system
approaches.
Since Congressional acceptance of
the Multilateral Trade Agreement of
the Standards Code in the summer of
1979, EPA has worked with the
Office of the U.S. Trade
Representative to coordinate policy on
standards negotiations that might
affect regulation of chemicals in
commerce.
EPA also is participating in the World
Health Organization (WHO)
International Program on Chemical
Safety and other WHO programs,
including the International Agency for
Research on Cancer, Environmental
Health Criteria Program, the Human
Monitoring Program, and the Codex
Alimentarius Commission (which
implements the joint Food and
Agriculture Organization/WHO Food
Standards Program).
EPA has been designated by the
United Nations Environmental
Programme (UNEP) as the U.S. Nation-
al Correspondent to the International
Registry of Potentially Toxic
Chemicals. The International Registry,
which is part of UNEP's global
environmental assessment program
will provide an internationally
accessible data base on chemical
substances.
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State Cooperative
Agreements
Section 28 of TSCA authorizes EPA to
award grants to States to establish
and operate programs to prevent or
eliminate problems created by toxic
substances. State applications for
such grants must: (1) set forth the
need for a grant; (2) identify the
agency(ies) that will establish and/or
operate the program; (3) describe the
actions proposed to be taken under
the program; (4) assure that the
program will be integrated with other
public health and environmental
programs; (5) provide for reports and
evaluations as EPA may require; and
(6) contain other information
requested by EPA.
On August 28, 1978, EPA announced
in the Federal Register the availability
of $3 million for this Federal
assistance program, and provided
guidance to prospective applicants.
The announcement also described a
two-cycle award process, each
awarding approximately half the
funds. The first cycle was to end 135
days after publication, while the
second would be completed later in
1980.
Nine States (Arkansas, California,
Illinois, Iowa, Maryland, Michigan,
New Jersey, New York, and
Wisconsin) applied for first cycle
funds. In April 1979, cooperative
agreements (grants requiring
substantial Federal involvement) were
awarded to Maryland, Michigan, New
Jersey, New York, and Wisconsin.
Maryland: $230,935 to the
Department of Health and Mental
Hygiene to develop a toxic substances
registry.
Michigan: $504,500 to the
Department of Natural Resources to
develop a Critical Materials Program.
New Jersey: $453,947 to the
Department of Environmental
Conservation to (a) develop a Toxic
Substances Investigation and
Integration Unit, and (b) expand a
current project to monitor volatile
organic compounds in air.
New York: $348,000 to the
Department of Environmental
Conservation to develop a program to
identify, characterize, and plan for the
management of toxic substances
problems.
Wisconsin: $202,847 to the
Department of Health and Social
Services to study health problems
related to formaldehyde vapors
emanating from mobile home
construction materials.
Nine new State applications were
received for the second cycle
(Colorado, Connecticut, Delaware,
Illinois, Louisiana, Michigan,
Minnesota, North Carolina, Oklahoma,
and Puerto Rico); including seven
applications held over from cycle one.
Sixteen State applications are being
considered for funding in the second
cycle. Awards of second cycle
agreements will occur in January
1980.
Also in January of 1980, EPA will
announce in the Federal Register the
availability of the balance of funds
identified for this program.
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Public
Participation
Considerable effort is being made to
encourage broad public participation
in EPA's TSCA activities. This effort
includes designing a pilot program to
compensate individuals or
organizations interested in
participating in specific rulemaking
proceedings. It also involves informing
the public on how to effectively
participate in toxic substances
activities.
Financial Compensation
(Intervenor Funding)
Section 6(c)(4) of the Act authorizes
the Agency to provide compensation
for reasonable expenses of
participating in TSCA regulatory
proceedings. Compensation may be
offered to participants if their
involvement would substantially
contribute to the resolution of
relevant issues; if their economic
interest is small in comparison to the
costs of effective participation; or if
they could not otherwise afford to
participate.
During 1980, EPA will fund a pilot
program to provide limited financial
compensation for three TSCA rules:
(1) Commercial and Industrial Uses of
Asbestos Fibers; (2) Asbestos
Materials in School Buildings; and (3)
Chemical Hazard Warning Labels. The
total intervenor funding for these
three rulemakings will be
approximately $30,000.
Grants
As part of the effort to inform the
public about toxic substances issues
and activities, small grants were
awarded to more than fifteen
national, State and local non-profit
organizations. Under these grants,
informational materials, a training
course, and technical issue papers
are being prepared; conferences and
workshops are being held; and local
task forces are being set up in regions
across the country.
In addition to increasing the general
public's level of understanding about
toxic substances problems, a major
effort is underway to involve labor,
public interest, environmental, public
health, urban, minority, civic and
educational groups in toxic
substances issues.
Advisory Committee
The Administrator's Toxic Substances
Advisory Committee, whose members
represent a broad variety of
backgrounds, interests, and expertise,
met three times during 1979 to
consider pending program decisions
and directions, and to advise the
Administrator on policy, procedural
and technical matters. Substantive
advice concerned the proposed TSCA
implementation approach, premanu-
facture review, asbestos control,
testing procedures, international
issues, risk assessment procedures,
and public participation.
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Industry
Assistance
In accordance with section 26(d) of
the Act, an Industry Assistance Office
was established in January 1977.
This Office provides information about
TSCA requirements to members of
the chemical industry and their trade
organizations.
Assistance and information provided
in 1979 included handling an average
of 2,200 telephone calls, and
distributing an average of 6,000
document copies each month. Four
slide presentations explaining
particular TSCA actions were
developed for industry use, and have
been loaned to 382 companies for
seminars and meetings. One provided
an overview of TSCA; each of the
others explained TSCA rules on
proposed premanufacture notification
requirements, asbestos, and the
revised inventory reporting rules.
Several "Q&A" booklets were
published for the proposed
premanufacture notification
requirements, polychlorinated
biphenyls, asbestos, and reporting
procedures for both the initial and
revised editions of the Chemical
Substance Inventory.
The Office handled arrangements for
23 meetings to obtain formal
comments from the public on
proposed regulatory actions, and met
on several hundred occasions with
individual company representatives to
clarify regulatory issues or to provide
assistance in carrying out TSCA
requirements.
The Office received requests for and
mailed over 7,200 copies of the initial
Chemical Substances Inventory and
its first Supplement.
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Regional
Offices
The ten EPA Regional Offices are
actively participating in TSCA
implementation activities. They are
providing technical aid and guidance
to help State and local officials reduce
asbestos exposures in schools, and
are helping utilities and States to
comply with the PCB rules.
The Regional Offices serve as a
communication front line on TSCA
and toxics-related issues to industry,
State and local governments, special
interest groups, and private citizens.
Several Regions are conducting
extensive public education programs
on toxic substances. One such effort
is underway in New Jersey, where a
wide variety of chemical-related
problems exist. Corrective measures
for chemical spills and information on
the health and environmental effects
of toxic chemicals are two more
services provided. An example was
the technical assistance EPA Regional
Offices gave to Midwest and Western
State organizations and private
citizens following the PCB
contamination of poultry, eggs, and
egg products in these areas during
the summer of 1 979.
EPA's ten Regional Offices are
located in: (1) Boston, Massachusetts;
(2) New York City, New York; (3)
Philadelphia, Pennsylvania; (4)
Atlanta, Georgia; (5) Chicago, Illinois;
(6) Dallas, Texas; (7) Kansas City,
Missouri; (8) Denver, Colorado; (9)
San Francisco, California; and (10)
Seattle, Washington. Each serves the
surrounding States; the Seattle Office
assists Alaska, the San Francisco
Office aids Hawaii and Guam, and the
Virgin Islands and Puerto Rico are
served by the New York City Office.
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Work Force
TSCA's implementation has increased
EPA's and the chemical industry's
need for employees trained in
scientific and technical professions.
The supply of trained professionals in
some of these areas, notably
toxicology, pathology, and
epidemiology, is barely adequate to
meet current needs. The increasing
requirements for hazard assessments
under TSCA and other Federal laws
will further strain this situation.
Through extensive recruiting efforts,
EPA has identified and hired qualified
scientists in some of these shortage
categories. However, in some areas,
such as veterinary pathology, industry
salaries are considerably higher than
those offered by government. As a
result, the Agency has had to obtain
certain expertise through contracts
with private organizations.
Various steps are being taken by EPA
to improve this situation. The Agency
is working with the Office of
Personnel Management to set up a
hiring register for toxicologists. Efforts
are being made to improve EPA's
recruiting contacts with educational
institutions. The Agency is working
with other Federal agencies to enlist
their cooperation in allowing people
trained in programs they support to
fulfill government employment
obligations by working at EPA. Also,
the Agency worked with one
university to develop a short,
specialized training course in
toxicology that is now available to
scientists with appropriate
backgrounds.
In addition, EPA is cooperating with
the National Academy of Sciences
(NAS) in a study to determine the
adequacy of federally supported
training. If increases are necessary,
EPA believes existing programs
should be expanded rather than new
ones started.
EPA is participating in the National
Institute of Environmental Health
Sciences' (NIEHS) evaluation of their
Environmental Toxicology Training
Program. A study is underway to
survey the types of toxicological
training offered, graduate employment
histories, present and future
employer needs, and program
expansion capacities. The results of
this study will document specific
employer needs for toxicologists. They
also will support NIEHS' efforts to
expand environmental toxicology
training, which, in turn, will facilitate
the implementation of laws, such as
TSCA, that require the assessment of
the effects of toxic substances on
human health and the environment.
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Litigation
In 1979, several lawsuits were
brouight under the Act. Three cases
involved PCBs. In Environmental
Defense Fund v. Environmental
Protection Agency (No. 79-1580, D.C.
Cir.), the Environmental Defense Fund
(EOF) petitioned the Federal Court of
Appeals for the District of Columbia
Circuit for review of the Agency's PCB
regulation issued on May 31, 1979
(44 FR 31514) under section 6(e) of
TSCA. EOF challenged the Agency's
decision to define the minimum
concentration of PCBs for most
purposes at 50 parts per million, and
also alleged that some or all of the
PCB use authorizations allowed under
the regulation are not supported by
substantial evidence in the record.
Two other cases involving this
regulation, brought by Alcoa (No. 79-
1811) and General Electric Company
(No. 79-1816), have been
consolidated with the EDF appeal. A
number of other parties, including the
Edison Electric Institute, the National
Electrical Manufacturers Association,
the Electronic Industries Association,
Joy Manufacturing Company, and
thirty-one utilities, also have
intervened in the EDF appeal. None of
these cases has been decided. A
petition for review of the PCB
regulation has also been filed in the
Federal Court of Appeals for the
Fourth Circuit in Richmond, Virginia
(Olin Corporation v. Environmental
Protection Agency No. 79-1437, 4th
Cir.). Olin has filed an appeal in the
event that EPA should later deny its
pending exemption petition to
manufacture a chemical with a PCB
contaminant in the process. This case
had not been decided by the year's
end.
The third PCB case, Dow Chemical
Company v. Douglas Costle (D. Del.),
was filed in the Federal District Court
in Wilmington, Delaware in December
1979. Dow contends that monochloro
biphenyls are improperly included
with the Agency's regulatory
definition of PCBs. The court granted
EPA's motion and dismissed Dow's
suit on the grounds that the court
lacked jurisdiction to hear the case
against the Agency. The court noted
that Dow could have filed an appeal
in a U.S. Court of Appeals within 60
days after promulgation of the
regulations.
EDF v. Costle, C.A.D.C. No. 79-1360,
involves the issue of asbestos-
containing materials which have been
applied in school buildings. The
Environmental Defense Fund (EDF)
on December 21, 1978, petitioned
EPA under section 21 of TSCA to
regulate such materials. On March
21, 1979, the Agency denied the
petition because it believed that the
fastest way to reduce the risk posed
by asbestos in schools would be to
establish a non-regulatory program to
provide technical guidance and
assistance to State and local officials
to identify and abate problems from
asbestos-sprayed materials in schools,
44 FR 20290 (April 4, 1979). Such a
program was announced in the
Federal Register on March 23, 1979,
44 FR 17790. EDF v. Costle was filed
in the District Court for the District of
Columbia in response to the denial of
the petition to compel the Agency to
initiate a rulemaking proceeding. The
Agency shortly thereafter
reconsidered the issues presented
and decided to grant the petition. This
decision was announced in the
Federal Register on July 13, 1979, 44
FR 40900. In addition, on September
20, 1979, EPA published an advance
notice of proposed rulemaking
discussing its plans for the
rulemaking proceeding, 44 FR 54676.
As a result of these actions, EDF
voluntarily dismissed its action in the
District Court on October 20, 1979.
The fifth case raised issues under
TSCA section 4. Section 4(e)(1)(A)
establishes an Interagency Testing
Committee (ITC) to recommend to the
EPA Administrator which chemical
substances and mixtures should
receive priority consideration for
testing rules. Within 12 months of the
time that the ITC designates
chemicals, EPA must initiate a
rulemaking proceeding or publish a
Federal Register notice explaining the
Administrator's reasons for not
initiating rulemaking (section
4(e)(1)(B)). EPA responded to the first
two ITC reports by stating that
rulemaking was not being initiated
within the year because EPA had not
yet completed its evaluation of the
ITC's recommendations or resolved
several basic scientific and policy
issues. The Natural Resources
Defense Council (NRDC) sued EPA,
NRDC v. Costle, No. 79-Civ. 2411
S.D.N.Y., arguing that the response
was deficient and that EPA had to
make the final determination within
twelve months to initiate or not
initiate rulemaking, giving section 4(a)
reasons for its decision. Industry trade
groups intervened on the
government's behalf. The Judge
granted NRDC's motion for summary
judgement and ordered the Agency, to
submit a plan for complying with
section 4(e).
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Finally, Dow Chemical Company filed
a petition for review of a rule that the
Agency promulgated under section
8(d), The Dow Chemical Company v.
EPA, No. 78-2203) (3rd Cir.). Section
8(d) authorizes EPA to obtain health
and safety studies on chemicals. In
August 1979 the court held for EPA
on the two technical issues of
statutory interpretation that were in
dispute: (1) chemicals manufactured
or processed by commercial
companies like Dow for research and
development are manufactured or
processed "for commercial purposes"
and are, therefore, subject to Agency
authority under 8(d); and (2) EPA may
obtain copies of health and safety
studies from any person in possession
of such study.
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Problems
Four major sections of TSCA require
or authorize EPA to issue regulations:
section 4 (chemical testing), section 5
(new-chemical reviews), section 6
(chemical control), and section 8
(information gathering). While the
Agency has made substantial
progress in implementing each of
these provisions, various problems
have arisen along the way, especially
in issuing section 4 testing rules.
Section 4 authorizes EPA to issue
regulations requiring manufacturers
and/or processors to test chemical
substances for health and
environmental effects and to issue
testing standards specifying the
procedures to be used in conducting
required tests. One of the problems
the Agency has encountered in
developing rules under section 4 has
been in making the finding required
under section 4(a)(1)(A)(ii) that
existing data are insufficient to
reasonably determine or predict the
effects on health and the environment
from the manufacture, processing, or
disposal of a chemical substance.
To determine that existing information
is insufficient the Agency has gone
through a number of steps:
(1) search the published literature for
relevant information;
(2) determine whether a rule is
necessary under section 8(d) to collect
unpublished health and safety
studies, and if so, issue such a rule;
(3) validate the methodologies and
conclusions of relevant studies;
(4) interpret the significance of
information on adverse health and
environmental effects; and
(5) determine whether the available
information is sufficient to find that
activities associated with the
chemical substance may present an
unreasonable risk, but insufficient to
reasonably determine or predict the
effects of those activities on health or
the environment.
This process of collecting and
evaluating relevant information on the
health and environmental effects of
chemicals being considered for a
section 4 testing rule has been
extremely resource-intensive and
time-consuming. Therefore, the
Agency is re-evaluating its approach
based on the length of time it is
taking to develop the first testing rule.
If these problems cannot be resolved
satisfactorily within the Agency, it
may propose legislative amendments
designed to remedy them.
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Appendix A
TSCA 1979: Principal Rules,
Regulations and Public
Notices Published in the
Federal Register
1. January 2, 1979. TSCA: Policy for
Implementation and Enforcement. 44 FR 108.
2. January 10, 1979. Proposed Regulations for
TSCA Premanufacturing Notification
Requirements and Review Procedures. 44 FR
2240.
3. January 19, 1979. EPA Sprayed Asbestos in
Schools: EOF Petition; Request for Comments.
44 FR 4009.
4. January 30, 1979. Notice of Administrator's
Toxic Substances Advisory Committee Meeting.
44 FR 5939.
5. January 31, 1979. EPA Health and Safety
Study Reporting Regulations; Revocation of
Rule Published July 18, 1978. 44 FR 6099.
6. February 5, 1979. Premanufacture
Notification Requirements & Review
Procedures: Notice of Meetings and Availability.
44 FR 6957.
7. February 7, 1979. EPA Transfer of TSCA
Inventory Information to Contractor. 44 FR
7811.
8. February 27, 1979. Premanufacture
Notification Requirements; Notice of Meeting.
44 FR 11099.
9. March 12, 1979. Disposal of PCB-
Comaminated Soil and Debris: Citizens'
Petition. 44 FR 13575.
10. March 16, 1979. TSCA Section 5 Testing
Guidelines. 44 FR 16240.
11. March 20, 1979. Interagency Toxic
Substances Data Committee: Current
Membership. 44 FR 16959.
12. March 23, 1979. Asbestos-Containing
Materials in School Buildings; Announces
Program and Provides Guidance Package. 44
FR 17790.
13. March 23, 1979. Toxic Substances Control;
Confidential Business Information. 44 FR
17673.
14. March 28, 1979. TSCA: Guidance for
Premanufacture Notification Testing Correction.
44 FR 18549.
15. March 29, 1979. Extends Comment Period
for Third ITC Report. 44 FR 18733.
16. April 4, 1979. Sprayed Asbestos in
Schools; Denials of Citizens' Petition. 44 FR
20290.
17. April 6, 1979. Notice of Administrator's
Toxic Substances Advisory Committee Meeting.
44 FR 20784.
18. April 19, 1979. FDA and TSCA: Quality
Assurance for Bioresearch Studies;
Memorandum of Agreement with the
Environmental Protection Agency. 44 FR
24233.
20. April 27, 1979. Interagency Regulatory
Liaison Group; Public Meeting. 44 FR 24903.
21. May 9, 1979. Proposed Health Effects Test
Standards for Toxic Substances Control Act
Test Rules. 44 FR 27333.
22. May 9, 1979. Good Laboratory Practice
Standards for Health Effects. 44 FR 27362.
23. May 9, 1979. Asbestos in Buildings; Denial
of Petition. 44 FR 27257.
24. May 11, 1979. Fully Halogenated
Chloroalkanes, Toxic Substances Control Act. 44
FR 27702.
25. May 14, 1979. Response to Interagency
Testing Committee Recommendations. 44 FR
28095.
26. May 15, 1979. Toxic Substances Control:
Initial and Revised Inventories;
Premanufacturing Notification Requirements
and Review Procedures. 44 FR 28557.
27. May 15, 1979. Toxic Substances;
Premanufacturing Notices; Monthly Status
Report. 44 FR 28410.
28. May 25, 1979. Interim Policy on
Premanufacture Notification Requirements and
Review Procedures; Review by Executive Office
of the President. 44 FR 30424.
29. May 29, 1979. Improving Environmental
Regulations; Final Report Implementing
Executive Order 12044. 44 FR 30988.
30. May 31, 1979. Polychlorinated Biphenyls
(PCBs) Manufacturing, Processing, Distribution
in Commerce and Use Prohibitions. 44 FR
31514.
31. May 31, 1979. Procedures for Rulemaking
Under Section 6 of the Toxic Substances
Control Act; Interim Procedural Rules for
Exemptions from the PCB Processing and
Distribution in Commerce Prohibitions. 44 FR
31558.
32. May 31, 1979. Polychlorinated Biphenyls
(PCBs); Proposed Rulemaking for PCB
Manufacturing Exemptions. 44 FR 31564.
33. May 31, 1979. Polychlorinated Biphenyls
(PCBs); Amendment to Criteria for Chemical
Waste Landfills. 44 FR 31567.
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34. May 31, 1979. Fully Halogenated
Chlorofluoroalkanes; Exemption for Inkless
Fingerprinting Systems. 44 FR 31238.
35. June 1, 1979. Fourth Report of the
Interagency Testing Committee; Receipt of the
Report and Request for Comments. 44 FR
31866.
36. June 14, 1979. Premanufacture Notices:
Status Report for May 1979. 44 FR 34193.
June 14, 1979. TSCA Fully Halogenated
Chlorofluorocarbons; Proposed Rule. 44 FR
34167.
38. June 27, 1979. Chemical Substances:
Reporting and Recordkeeping; Advanced Notice
of Proposed Rulemaking. 44 FR 37517.
39. June 28, 1979. Toxic Substances:
Postponement of Public Meeting Date. 44 FR
37682.
40. July 3, 1979. Extension of
Premanufacturing Notification Period. 44 FR
39026.
41. July 9, 1979. Disposal of PCB-
Contaminated Soil and Debris; Denial of
Citizens' Petition. 44 FR 40132.
42. July 13, 1979. TSCA Grant of Petition to
Initiate Rulemaking Proceeding to Regulate
Sprayed Asbestos in Schools. 44 FR 40900.
43. July 20, 1979. Proposed Rulemaking for
Polychlorinated Biphenyls (PCBs);
Manufacturing Exemptions. 44 FR 42727.
44. July 26, 1979. Proposed Health Effects
Test Standards for TSCA Test Rules and
Proposed Good Laboratory Practice Standards
for Health Effects. 44 FR 44054.
45. July 30, 1979. Receipt of Premanufacture
Notice. 44 FR 44930.
46. August 16, 1979. Council on
Environmental Quality: Report to the President
by the Toxic Substances Strategy Committee.
44 FR 48134.
47. August 21, 1979. IRLG: Testing Standards
and Guidelines Work Group; Availability of
Draft Guidelines and Public Meeting. 44 FR
49015.
48. September 18, 1979. Receipt of
Premanufacture Notice. 44 FR 54118.
49. September 18, 1979. Data Reimbursement
Under Sections 4 and 5 of TSCA. 44 FR 54284.
50. September 19, 1979. Fully Halogenated
Chlorofluoroalkanes, Final Rule. 44 FR 54298.
51. September 19, 1979. Fully Halogenated
Chlorofluoroalkanes; Inkless Fingerprinting
Systems. 44 FR 54297.
52. September 19, 1979. Polychlorinated
Biphenyls Disposal Requirements; Amendment
to Final Rule, Sedgwick County, Kansas. 44 FR
54296.
53. September 20, 1979. Asbestos-Containing
Materials in School Buildings; Advance Notice
of Proposed Rulemaking. 44 FR 54676.
54. October 2, 1979. Proposed Rule and
Interim Guidance for Notification of Export for
PCB and Fully Halogenated Chlorofluoro-
alkanes. 44 FR 56856.
55. October 10, 1979. National Emissions
Standards for Identifying, Assessing and
Regulating Airborne Substances Posing a Risk
of Cancer; National Emissions Standards for
Hazardous Air Pollutants: Advance Notice of
Proposed Generic Standards 44 FR 58642.
56. October 12, 1979. Submission of Notice of
Manufacture or Importation of PBBs and Tris;
Proposed Rule. 44 FR 59106.
57. October 16, 1979. Reproposal of TSCA
premanufacturing Notice Forms and Provisions
of Rules. 44 FR 59764.
58. October 17, 1979. Commercial and
Industrial Use of Asbestos Fibers and
Consumer Products Containing Asbestos. 44 FR
60056.
59. October 17, 1979. Statement of Regulation
of Chemical Carcinogens; Policy and Request
for Public Comments. 44 FR 60038.
60. October 18, 1979. Granting of'Citizens'
Petition To Initiate Regulatory Proceedings To
Control Asbestos Cement Pipe. 44 FR 60155.
61. October 22, 1979. Exports of Toxic
Substances; Notification of Export Under
Section 12(b). TSCA, Proposed Amendment to
Inventory Reporting Requirements. 44 FR
60763.
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62. November 9, 1979. Availability of a
Supplement to the TSCA Chemical Substances
Inventory. 44 FR 65180.
63. November 21, 1979. Polychlorinated
Biphenyls; Approved PCB Disposal Facilities. 44
FR 66989.
64. November 21, 1979. Polychlorinated
Biphenyls (PCBs); Proposed Amendment to the
Disposal Requirements for Large PCB
Capacitors in Chemical Waste Landfills. 44 FR
66851.
65. November 23, 1979. Reporting
Requirements: Submission of Notice of
Manufacture or Importation of PBBs and Tris;
Corrections. 44 FR 67183.
66. November 23, 1979. Data Reimbursement
Under Sections 4 and 5 of the Toxic
Substances Control Act; Extension of Comment
Period. 44 FR 67183.
67. November 23, 1979. Interagency
Regulatory Liaison Group: Epidemiology Work
Group; Availability of Draft Guidelines. 44 FR
67232.
68. November 26, 1979. Premanufacture
Notice Status Report for October 1979. 44 FR
67523.
69. November 20, 1979. Premanufacture
Exemption Application. 44 FR 66671.
70. November 29, 1979. Polychlorinated
Biphenyls (PCBs), Manufacturing, Processing,
Distribution in Commerce, and Use
Prohibitions; Clarification and Proposed
Amendment on Hydraulic Machines. 44 FR
68489.
71. December 7, 1979. Priority List of
Chemical Substances Recommended for
Testing; Fifth Report of the Interagency Testing
Committee to the Administrator, EPA, Receipt
of the Report, Request for Comments; and
Corrections to the Fourth Report of the
Interagency Testing Committee. 44 FR 70663.
72. December 17, 1979. Commercial and
Industrial Use of Asbestos Fibers; Extension of
ANPRM Comment Period and Announcement
of Additional Control Option. 44 FR 73127.
73. December 31, 1979. Proposed Rule for
Health and Safety Data Reporting; Submission
of Lists and Copies of Health and Safety
Studies. 44 FR 77470.
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