740R79102
Second
Annual Report
(1978)
Administration
of the
Toxic Substances
Control Act
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Table of Contents
1 Highlights
1 Summary
2 TSCA Inventory
3 Premanufacture Notification
4 Testing
4 Risk Assessment
5 Control Actions
5 Pjolychlorinated biphenyls (PCBs)
5 Chlorofluorocarbons (CFCs)
6 Asbestos
6 Enforcement
7 Reporting and Recordkeeping
8 Data Systems
8 Data Security and Disclosure
9 Research
9 Coordination
9 Interagency Regulatory Liaison Group (IRLG)
9 International Cooperation
10 Public Participation
10 Compensation
10 Grants
10 Advisory Committee
10 EPA-State Cooperative Agreements
11 Work Force
11 Industry Assistance
1 2 Regional Offices
12 Litigation
13 Problems
14 Appendix A (Principal Rules,Regulations,
Public Notices)
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Highlights
Summary
This is the Environmental Protection
Agency's (EPA) second Annual Report
on the administration of the Toxic
Substances Control Act (TSCA). This
report provides the information
required by sections 30, 9(d), and 28(c)
of the Act, as well as additional infor-
mation on the Agency's implementa-
tion of the Act.
During the last thirteen months, sig-
nificant progress has been made in lay-
ing the groundwork for implementing
many of the major provisions of the
Toxic Substances Control Act. In
January 1979, EPA published pro-
posed rules under which manufacturers
would have to notify the Agency
before manufacturing new chemical
substances. This premanufacture noti-
fication program will begin 30 days
after publication of the Agency's initial
Inventory of chemicals in commerce.
EPA expects to publish the initial
Inventory on or about June 1, 1979.
In April 1979, the Agency expects to
issue its first proposed standards for
health effects testing. These standards
will prescribe methodology for onco-
genicity and other chronic health
effects testing; simultaneously the
Agency will issue proposed Good
Laboratory Practice (GLP) standards
for health effects testing. The selection
of chemicals to be tested in accordance
with these standards is proceeding.
EPA expects to publish later this year
the first proposed rule to require the
testing of specific chemicals or groups
of chemicals.
Two regulations governing activities
involving specific chemicals were issued
in 1978. Final regulations dealing with
the marking and disposal of poly-
chlorinated biphenyls (PCBs) were
issued in February, and final regula-
tions banning nonessential aerosol uses
of chlorofluorocarbons were issued in
March. Additional regulations dealing
with PCBs will be issued in March
1979; they will lay out the rules for
implementing the statutory ban on the
manufacture, processing, and distribu-
tion of PCBs and on non-totally
enclosed uses. The Agency also has
initiated, in cooperation with the
Department of Health, Education, and
Welfare, State agencies, and school
districts, a national program to identify
and deal with deteriorating sprayed
asbestos material in public schools; the
possibility of supplementing this initial
effort with a regulatory program is
being examined.
This section is intended to help
readers of this Annual Report locate
the information specifically required by
certain provisions of the Act that call
for annual reporting to the Congress
and/or the President.
Section 30 of the Act contains the
basic requirement for an Annual
Report and specifically calls for the
following information:
1. Testing required under section 4:
Thus far, no testing requirements have
been established. See the section on
Testing for a description of work in
progress on the development of testing
standards and rules.
2. Premanufacture notices received:
Premanufacture notification regarding
new chemical substances will not be
required until 30 days after the TSCA
Inventory is officially published. See
the section on Premanufacture Notifi-
cation for information on the Agency's
progress in developing this program.
3. Rules issued under section 6: Final
rules governing marking and disposal
of polychlorinated biphenyls (PCBs)
and chlorofluorocarbons (CFCs) were
issued last year. Proposed rules to
implement the statutory ban on manu-
facture, processing, distribution, and
non-totally enclosed use of PCBi were
published in June 1978. See the section
on Control Actions for additional
information on these rulemaking
activities.
4. Judicial actions under TSCA and
administrative actions under section 16:
Two suits raising significant issues have
been brought; see the section on Liti-
gation for additional information.
Several enforcement actions resulting
in civil penalties have been taken; see
the section on Enforcement for addi-
tional information.
5. Problems encountered in TSCA
implementation: See the section on
Problems for a brief discussion of
administrative and policy problems.
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TSCA Inventory
6. Recommended legislation: No
additional legislation is being recom-
mended at this time.
Section 9(d) requires that the Annual
Report include information on coordi-
nation of activities under TSCA with
related activities with other Federal
laws. Such information appears in the
section on Coordination and, as appro-
priate, in other parts of this document.
Section 23(c) requires an annual
report on grants made to States. See
the section on EPA State Cooperative
Agreements for information on the
status of this program.
Appendix A contains a list of the
principal rules and regulations and
other important public notices pub-
lished thus far.
The initial TSCA Inventory, required
under section 8(b) of the Act, will be
published on or about June 1, 1979.
The initial Inventory is based on
approximately 140,000 reporting forms
submitted by nearly 7,400 firms. It will
include some 45,000 unique chemical
substances, most of which will be sub-
stances that have a specific chemical
structure, such as formaldehyde and
benzene. Most of the remaining sub-
stances on the Inventory will be unde-
fined, variable composition chemicals,
such as castor oil and coal tar.
When the Inventory is published, it
will contain the identity of nearly all
chemicals reported to the Agency.
Confidentiality claims were made for
the identify of fewer than 2,000 sub-
stances. These will be listed separately
with their identities masked to prevent
unauthorized disclosure of confidential
information.
In addition to obtaining information
on chemical substance identity, the
Agency collected data on the 1977 pro-
duction volume of each substance at
each manufacturing site (except that
small companies did not have to sub-
mit these data). EPA will use this
information in setting priorities for
TSCA activities and for other pur-
poses; for example, where environ-
mental incidents occur, the production-
site information will be helpful in iden-
tifying possible sources of such con-
tamination.
A substantial portion of the site-
specific production data is covered by
confidentiality claims. EPA is examin-
ing various ways of aggregating and
summarizing such data so that it can
provide the public with a general pic-
ture of commercial chemical manu-
facturing in the United States.
A second reporting period of 210
days will begin with the official pub-
lication of the initial Inventory. It will
allow 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 will have an
opportunity to ensure that substances
which actually were in commerce in
1977 appear on the Inventory, even
though they may not have been
reported by any manufacturer. Any
substance not included in the Inventory
will be "new" under TSCA and, there-
fore, will have to go through premanu-
facture notification before it can
legally be manufactured or processed
or imported as a bulk chemical.
2
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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 before commencing
manufacture. A "new chemical
substance" is any chemical substance
not included on the Inventory of exist-
ing substances to be published by EPA
under section 8(b). Thirty days after
official publication of the initial
Inventory, the requirements of section
5 become effective.
During 1978, EPA developed rules
and notice forms for the premanufac-
ture program. The Agency proposed
the rules and forms in the Federal
Register on January 10, 1979, allowed
a 75-day public comment period, and
held public meetings at several places
around the country. After reviewing
the public record, the Agency will pro-
mulgate the rules and forms during the
latter part of this year.
The proposed rules include provi-
sions covering: who would have to sub-
mit notices and who would not; the
types of chemicals subject to notifica-
tion and those excluded; how, where,
and when to submit notices (with
special provisions for imports); the
information to be included in notices.
The rules also would contain EPA's
procedures for receiving, processing,
and reviewing notices, for handling
deficient and invalid notices; and for
initiating action to obtain additional
data on new chemicals before their
introduction or to regulate the produc-
tion, use, or disposal of new chemicals.
Also included would be general provi-
sions for handling and protecting
confidential information; special provi-
sions concerning information on
chemical identity and use and data
from health and safety studies; and
procedures for requiring additional
reporting under sections 5 and 8 of the
Act.
The proposed general notice form
would identify the specific information
requirements applicable to new
chemical substances, including both
mandatory and optional information.
Manufacturers would be required to
submit information concerning testing
they have performed and exposures to
humans and the environment. At their
discretion, they could submit other
information that may be useful in
EPA's assessment, including informa-
tion on steps that would be taken to
control exposures and on the economic
significance of their new chemicals.
EPA also published for public com-
ment three other forms designed for
use in connection with new imported
chemicals.
EPA has given considerable atten-
tion to testing of new chemical sub-
stances and, in particular, to the need
for testing guidelines. The Agency did
not propose guidelines with the rules
and forms, but it has published in the
Federal Register a detailed discussion
of the major testing issues, as well as
alternative ways of providing guidance.
This publication also described a
number of testing methods EPA con-
siders appropriate for evaluating a
wide range of health and ecological
effects and environmental fate
characteristics. The Agency has asked
for public comment on the issues,
alternatives, and testing methods. After
considering the public comments, EPA
plans to issue a formal proposal
regarding testing guidelines.
In developing the proposed rules and
notice forms, EPA provided extensive
opportunity for public participation.
The Agency held six public meetings to
discuss major issues with representa-
tives of environmental and other public
interest groups, organized labor, the
chemical industry, and others. Further,
EPA staff members had many
meetings with representatives of indi-
vidual groups to discuss specific issues,
and the Agency distributed prepublica-
tion drafts of the proposed rulemaking
for review and comment.
In addition to developing this pro-
posed rulemaking, EPA initiated
efforts during 1978 to establish a pro-
cess for receiving, reviewing, and
making regulatory decisions concerning
new substances. This included the
development of appropriate internal
organizational structures, the recruit-
ment of necessary staff, and interac-
tion with other EPA offices and
Federal agencies to define their respec-
tive involvements in reviewing pre-
manufacture notices.
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Testing
Risk Assessment
Under section 4 of the Act, the Agency
is authorized to issue regulations
requiring manufacturers and/or pro-
cessors to test chemical substances for
health and environmental effects and
to issue testing standards specifying the
procedures to be used in conducting
required tests.
Proposed standards for testing of
chemicals to determine whether they
could produce oncogenic effects (i.e.,
tumors) and other chronic effects are
due to be published in April 1979. Pro-
posed Good Laboratory Practice
(GLP) standards for health effects
testing will be published at the same
time. The testing standards for onco-
genic and other chronic effects are
largely the same as those contained in
EPA's guidelines for pesticide testing.
The GLP standards are virtually iden-
tical to those issued by the Food and
Drug Administration. Other health
effects test standards under develop-
ment include those for acute toxicity,
subchronic toxicity, teratology, muta-
genicity, and reproductive effects.
Also underway is the development of
test standards for ecological effects and
chemical fate in the environment.
Ecological effects testing will be
designed to assess the potential impact
of chemicals on aquatic arid terrestrial
ecosystems. Chemical fate testing will
be designed to provide insights into the
mobility and persistence of chemicals
in air, land, and water; such informa-
tion is needed to assess exposures and
identify populations at risk.
About two dozen chemicals and
groups of chemicals currently are can-
didates for inclusion in rules requiring
actual testing. Among them are those
recommended by the Interagency
Testing Committee established under
section 4(e) of the Act. The first testing
rule is scheduled to be proposed later
this year and will provide a context for
dealing with a number of significant
policy and technical issues. It will
require testing of a limited number of
chemicals and groups of chemicals but
will be followed by others covering
larger numbers of high priority (for
testing) chemicals.
Assessment of the nature and
magnitude of risks that chemicals may
present to human health and the envi-
ronment is a necessary element of most
TSCA implementation activities. Risk
assessment is necessary in connection
with the Agency's premanufacture
review of new chemicals and significant
new uses, investigation and regulation
of chemicals already in commercial
use, selection of chemicals for which
testing requirements should be estab-
lished, and, among other things, evalu-
ation of "substantial risk" information
submitted under section 8(e). Although
risk assessment, in general, always
includes an evaluation of information
on potential adverse effects (derived
from animal testing, epidemiological
studies, or other sources) and on envi-
ronmental and human exposure, TSCA
risk assessments cannot all be per-
formed in precisely the same way.
They will have to be more or less
detailed, depending on time con-
straints, data availability, and the pur-
pose of each risk assessment. Thus, an
initial evaluation of a chemical for
which "substantial risk" information is
reported under section 8(e) is done very
quickly and provides only a prelimi-
nary judgment, while a risk assessment
to support significant regulatory action
generally will take several months and
result in production of an exhaustive
analysis. Over the past several months,
a substantial effort has been devoted to
developing a well-defined process for
performing each of the various types
of risk assessments needed for TSCA
implementation. These efforts are now
nearing completion.
To permit the Agency to focus
resources on the highest priority
chemicals as much as possible, all
major risk assessment processes will be
multi-staged. An example of this
approach is the comprehensive process
to be used in identifying and evaluating
risks associated with the manufacture,
processing, distribution, use, and dis-
posal of chemicals already in commer-
cial use. Approximately 45,000
chemical substances are already in
commercial use in this country. Per-
forming a detailed evaluation of each
one is not practical. In the Agency's
comprehensive assessment process,
large numbers of chemicals will
undergo preliminary assessments
designed to indicate which ones are or
are not likely to present significant
risks and identify those for which addi-
tional information is needed. In each
stage, some chemicals will be chosen
for more intensive investigation; ulti-
mately, where it is apparent that con-
trol action is needed, detailed risk
evaluations will be prepared. In this
process, efforts will be made to iden-
tify and assess the full range of adverse
effects and exposure sources of pos-
sible significance to human health and
environment.
Chemicals already in commercial use
are chosen for risk assessment on the
basis of information received from
various sources, including chemical
companies, other EPA programs and
other Federal agencies, and individual
citizens and groups. In addition, using
the TSCA Inventory of chemical sub-
stances as a starting point, the Agency
will be selecting chemicals for risk
assessment based on information
already available or additional infor-
mation obtained from chemical com-
panies in compliance with reporting
and recordkeeping rules to be issued
under section 8.
A substantial number of chemicals
already have undergone or are under-
going risk assessment. Preliminary
assessments of 49 chemicals have been
completed. Nineteen chemicals are in
the second stage of the comprehensive
assessment process, which involves a
more detailed review of adverse effects
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Control Actions
and exposure sources. Three are in the
third stage, which involves in-depth
review of the validity and significance
of existing data. These three are
asbestos, chlorofluorocarbons, and
nitrilotriacetic acid (NTA).
In addition, EPA is cooperating with
several other organizations to develop
agreed-upon scientific approaches to
risk assessment for various effects. For
example, EPA participated in the
Interagency Regulatory Liaison
Group's development of a major docu-
ment describing a common approach
to the scientific assessment of hazard
and risk of cancer from chemicals.
This approach will be used by EPA in
carrying out assessments under TSCA.
Similarly, EPA has sponsored a
major scientific review of the more
than 25 tests used to predict generic
effects of chemicals (mutagenicity).
This program, called GENE-TOX, is
expected to yield important results later
this year to assist EPA and the scien-
tific community in assessments of
mutagenicity.
EPA is establishing an Office of
Health and Environmental Effects
Assessment in the Office of Research
and Development to serve as a focal
point for Agency-wide efforts to
develop agreed-upon risk assessment
methods for several key health effects.
Polychlorinated biphenyls (PCBs)
Section 6(e) of the Act requires EPA to
establish rules governing the marking
and disposal of PCBs and prohibits,
with certain exceptions, the manufac-
ture, processing, distribution, and non-
totally enclosed use of PCBs. EPA
issued marking and disposal rules in
February 1978 and is about to issue
rules carrying out the statutory prohi-
bitions.
PCBs had been widely used in the
United States (and elsewhere) for some
40 years prior to the enactment of
TSCA. They had been used primarily
as dielectric fluid in transformers,
capacitors, and other electrical equip-
ment, but also in hydraulic and heat
transfer systems and for various other
purposes. Before their human health
and environmental hazards were recog-
nized, PCBs had already been widely
dispersed in the environment, with the
result that measurable amounts can be
found in soils, water, fish, milk, and
human tissue.
The Agency's PCB marking rules
require that PCB containers,
transformers, large high-voltage
capacitors, and various other PCB-
containing items be marked to ensure
that persons handling, transporting,
and disposing of them are aware that
they are subject to the TSCA rules
governing processing, distribution, use
and disposal. Under certain cir-
cumstances, vehicles transporting PCBs
also have to be marked.
In general, the PCB disposal rules
will require that PCBs and PCB items,
when removed from service, be dis-
posed of in high-temperature
incinerators, chemical waste landfills,
or, in certain cases, high-efficiency
boilers having PCB-destruction effi-
ciency of 99.9 percent. For certain
large-volume materials sometimes con-
taminated with PCBs, such as dredge
spoil and municipal sewage sludge,
alternative disposal methods may be
approved by EPA's Regional Adminis-
trators. PCB disposal facilities must
meet certain technical specifications
included in EPA's rules. Several
chemical waste landfills have been
found to meet the criteria; several
others are being evaluated. Applica-
tions for approval of several high-
temperature incinerators are under
consideration.
The Agency's PCB ban rules will,
with a few specified exceptions, pro-
hibit manufacture, processing, distribu-
tion, and non-totally enclosed use of
PCBs. Unless a specific exemption is
sought and granted, all manufacturing
of PCBs will be prohibited after the
effective date of the EPA rules, and all
processing and distribution will be pro-
hibited after July 1, 1979. Persons
wishing to continue such activities must
petition the Agency for a specific
exemption.
EPA estimates that about 750
million pounds of PCBs are still in use.
Uses of this material in a totally
enclosed manner (e.g., in transformers
and capacitors) can continue indefi-
nitely (with servicing to be performed
under EPA authorizations valid for a
maximum of five years). The Agency's
disposal rules apply to about 60 per-
cent of the PCBs now in use. The
remaining 40 percent consists almost
entirely of PCBs in millions of small
capacitors (e.g., those used in house-
hold fluorescent lights). Such capaci-
tors are so numerous that regulatory or
other control of their disposal would
be totally impractical.
Chlorofluorocarbons (CFCs)
In March 1978, jointly with the Food
and Drug Administration (FDA) and
the Consumer Product Safety Commis-
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Enforcement
sion (CPSC), EPA issued final rules
prohibiting manufacturing and process-
ing of chlorofluorocarbons (CFCs) for
non-essential aerosol uses. This action
was taken on the basis of evidence that
CFCs are depleting the stratospheric
ozone layer that protects the earth
against damaging ultraviolet radiation
from the sun.
The FDA's rules apply to the use of
CFCs in food, drug, and cosmetic
products. EPA's rules apply to all
other uses, including most uses of
CFCs in pesticides. The Consumer
Product Safety Commission worked
with EPA and FDA in developing their
rules, but because CPSC's and EPA's
jurisdiction overlaps, CPSC did not
issue separate rules.
EPA is encouraging other nations to
take similar action to control aerosol
uses of CFCs and is investigating the
need to control other uses of CFCs,
including their use in refrigeration and
cooling systems, in manufacture of
foamed material, and as solvents.
CPSC, FDA, and other Federal agen-
cies are cooperating with EPA in this
investigation. Two public meetings on
this problem have been held. EPA
expects to make a decision this year on
the need for additional regulatory
action.
Asbestos
For about 25 years prior to 1973,
sprayed asbestos-containing material
was used inside buildings for fire-
proofing, thermal and acoustical insu-
lation, and decorative purposes. In
1973, under the Clean Air Act, EPA
prohibited spraying of such material
(usually done before buildings were
enclosed) because workers and persons
in the vicinity were being exposed to
asbestos during spraying operations.
Application of sprayed asbestos-
containing material for decorative pur-
poses was prohibited in 1978.
There is now wide recognition that
sprayed asbestos-containing material in
many buildings is deteriorating, with
the result that the occupants are being
exposed to asbestos fibers. Evidence
from both occupational and nonoccu-
pational studies indicates that exposure
to asbestos fibers can result in the
occurrence of asbestosis and other
serious lung diseases, as well as some
types of cancer.
An undetermined number of public
schools are among the buildings where
asbestos exposure may be occurring.
As an initial step toward dealing with
this problem, EPA has initiated a
nationwide program designed to help
States and school districts identify
schools where deteriorating asbestos-
containing material should be removed
or sealed. EPA has developed and is
distributing a detailed technical guid-
ance package and is providing training
and technical assistance to State and
public school officials. In addition, the
Agency is asking school districts to
provide information on the extent of
the problem and their plans for correc-
tive action.
EPA is also considering the possibil-
ity of taking regulatory action to deal
with this problem, but will not take
such action at least until it has evalu-
ated the first six months' experience
with the cooperative Federal-State-
school district program. The Agency
also is assessing health risks associated
with many other uses of asbestos and,
in the near future, will decide whether
to initiate rulemaking to reduce human
exposure related to any of those uses.
EPA has initiated eight enforcement
actions dealing with alleged violations
of the PCB marking and disposal
rules. One was a criminal case involv-
ing illicit dumping of PCBs; the other
seven were civil actions.
On January 27, 1979, the Agency
successfully completed the first
criminal prosecution under TSCA
when Robert J. Burns and his two sons
pleaded guilty to charges stemming
from illicit dumping of PCB-
contaminated oil along 210 miles of
North Carolina roadways. EPA coop-
erated with the State in investigating
the incident. The State still has
criminal charges pending, and sen-
tencing has been deferred until the
State's case is concluded.
Civil penalties totalling $28,600 have
been assessed against two companies
for improper disposal of PCBs.
Charges involving alleged improper
marking, storage, or disposal are pend-
ing against five other companies. Other
possible violations are being investi-
gated.
Other enforcement activities have
included inspections to check on com-
pliance with the rules banning non-
essential aerosol uses of chlorofluoro-
carbons; joint efforts with the U.S.
Customs Service to develop procedures
for ensuring that imported chemicals
comply with TSCA requirements;
several investigations related to the sec-
tion 8(e) requirement for submittal of
substantial risk information; and devel-
opment of procedures for coordinating
enforcement activities with other agen-
cies in the Interagency Regulatory
Liaison Group (IRLG).
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Reporting and
Recordkeeping
Section 8 of the Act empowers EPA to
obtain various kinds of information
from chemical manufacturers and pro-
cessors and, in many instances,
distributors, as well. Publication of
EPA's rules requiring reporting for the
TSCA chemical Inventory was the
Agency's first use of its section 8
authority. Other activities under sec-
tion 8 are described here.
Section 8(a) authorizes the Agency to
establish rules under which chemical
manufacturers and processors can be
required to maintain and report infor-
mation on the identity, structure, uses,
and production of chemicals, worker
exposures, human health and environ-
mental effects, and other factors. For
the most part, EPA expects to use 8(a)
rules to obtain information needed to
identify and assess potential problems
and support control actions under
TSCA or other Federal laws. The
Agency currently is preparing a pro-
posed rule to require submittal of basic
data needed to screen a large number
of chemicals for indications of poten-
tial problems. In accordance with a
statutory requirement specifically
applicable to section 8(a), rules under
8(a) will provide for small business
exemptions.
Section 8(b) calls for compilation of
the TSCA Inventory based on data
obtained under an 8(a) rule. EPA's
work on the Inventory is described
elsewhere in this report.
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 currently is developing
a proposed rule to require that such
information be maintained and, where
specified conditions exist, that it be
submitted to the Agency. EPA is
attempting to harmonize this proposed
rule with similar rules established by
the Consumer Product Safety Commis-
sion and the Occupational Safety and
Health Administration.
Under Section 8(d), the Agency can
require submittal of health and safety
studies. EPA issued its first 8(d) rule in
July 1978; it required reporting of
unpublished studies of chemicals that
had been recommended for testing by
the TSCA Interagency Testing Com-
mittee established under section 4(e).
EPA's purpose in issuing the rule was
to obtain health and safety data for
use in determining whether to require
the testing the Committee had recom-
mended. In January 1979, after a sub-
stantial number of studies had been
submitted, thus providing the informa-
tion the Agency was seeking on studies
already performed, the rule was
revoked. In the near future, the
Agency plans to propose a new 8(d)
rule for future use in requiring sub-
mittal of health and safety studies.
Under section 8(e), chemical manu-
facturers, processors, and distributors
are required to report information that
reasonably supports a conclusion that a
chemical substance or mixture presents
a substantial risk of injury to health or
the environment. As of January 1,
1979, the Agency had received more
than 250 substantial risk notifications.
A few contained information that has
prompted the Agency to put the
chemicals in question into the TSCA
risk assessment process (which is
described elsewhere in this report).
Many others contained information of
possible interest to other Federal agen-
cies (particularly the Occupational
Safety and Health Administration and
the National Institute of Occupational
Safety and Health), which has been
transmitted to them. Still others con-
tained data which had already come to
the Agency's attention or which were
not significant in terms of their impli-
cations for human health or the envi-
ronment. All 8(e) notices are reviewed
within a short time after they are
received. A report is prepared on each
one and is placed in a public file.
7
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Data Systems
Data Security and
Disclosure
Section l-0(b}-of the_Act calls for the
development of efficient and effective
systems for collection, storage,
retrieval, and dissemination of infor-
mation submitted to EPA under the
Act, as well as other toxicological and
scientific data that could be useful in
TSCA implementation. Section 10(b)
also calls for the creation of an inter-
agency committee to aid EPA in
establishing such systems.
EPA is establishing the Chemicals in
Commerce Information System
(CIC1S) for data submitted to the
Agency under TSCA. CICIS is
expected to be fully operational about
the middle of this year. An automated
system for public access to non-
confidential CICIS data is being devel-
oped and should be in place next year.
In accordance with section 10(b),
EPA and the Council on Environ-
mental Quality (CEQ) jointly estab-
lished the Interagency Toxic Substances
Data Committee in February 1978.
Members include the Department of
Health, Education, and Welfare and
several of its component agencies, the
Departments of Labor, Commerce,
Agriculture, Interior, Defense, Trans-
portation, State, and Energy, the Con-
sumer Product Safety Commission,
International Trade Commission, and
National Science Foundation.
Based on recommendations made in
CEQ's report to the Congress under
section 25(b) of the Act, the Inter-
agency Committee is constructing a
comprehensive Chemical Substances
Information Network (CSIN). CSIN
will enable users of toxic substances
data to have access to a number of
data banks, including CICIS. Core
components of CSIN will include a file
describing each system in the network,
designed to direct users to the particu-
lar data bank that will meet their
needs; chemical identification data for
about 500,000 substances and a pointer
to other files containing information
on particular substances; a storage and
retrieval system containing data from
chemical testing; a reference system for
toxicological and other biomedical
journals; information on laboratory
animal strains for use in designing
testing programs; and information on
chemical standards, regulations, and
guidelines.
CSIN will represent a significant ad-
vance in Federal interagency coopera-
tion in making toxic substances data
readily available to meet the needs of
governmental and non-governmental
organizations. To the extent that it
enables Federal agencies to locate and
use data that have already been com-
piled, it can be expected to reduce
reporting requirements imposed on
chemical companies and other commer-
cial and industrial firms. CSIN is ex-
pected to be in partial operation next
year. The Interagency Committee has
designated EPA as the CSIN adminis-
trator.
To provide maximum security for con-
fidential business information sub-
mitted under TSCA, the Agency has
developed detailed procedures to safe-
guard confidential information through
controls on physical security, custody,
access, and computer storage and pro-
cessing. A manual describing these pro-
cedures was published in July 1978.
During its development, EPA studied
security procedures used by other
Federal agencies and by chemical com-
panies. A public meeting to discuss a
draft of the security manual was held
in April 1978.
In September 1978, EPA amended
its confidential business information
regulations, particularly as they apply
to information claimed to be confiden-
tial at the time it is submitted under
TSCA. The amendments reaffirm
EPA's policy of protecting business in-
formation that is entitled to confiden-
tial treatment, unless disclosure is
specifically required by TSCA. The
amendments also provide that EPA
will always give notice to affected
businesses before information claimed
to be confidential is publicly disclosed
or disclosed to other Federal agencies,
Congress, or contractors or under
Federal court orders.
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Research
Coordination
EPA's Office of Research and Devel-
opment is playing a significant role in
TSCA implementation by providing
short-term technical assistance in deal-
ing with specific problems and by
undertaking longer-term research to
develop new knowledge and techniques
needed to evaluate and control chemi-
cal hazards.
In the health effects testing area,
EPA's researchers are developing a
variety of screening methods. This ef-
fort is focused on behavioral toxicity
and neurotoxicity. They also are
developing methods that can be used to
determine whether a chemical could
cause congenital abnormalities that
would not necessarily be apparent at
birth.
To aid in assessing environmental ef-
fects of chemicals, EPA researchers are
engaged in validating various ecological
effects testing methods and in develop-
ing methods that can be used to simu-
late and predict the fate and transport
of chemicals in the environment.
EPA researchers are providing a sub-
stantial amount of technical support to
the development of the TSCA pre-
manufacture notification program and
the Agency's program for identifying
and dealing with deteriorating sprayed-
on asbestos material in public build-
ings. In support of the latter effort,
EPA researchers are evaluating mater-
ials that could be used to coat and seal
sprayed-on asbestos and are developing
analytical methods for use in assessing
exposure levels.
Interagency Regulatory Liaison Group
(IRLG)
The Interagency Regulatory Liaison
Group (IRLG) is a unique partnership
of Federal agencies involved in regulat-
ing hazardous substances. IRLG origi-
nally consisted of four Federal agen-
cies: EPA, Consumer Product Safety
Commission, Food and Drug Adminis-
tration, and Occupational Safety and
Health Administration. The Food Safe-
ty and Quality Service of the U.S.
Department of Agriculture recently
became a member.
One of the IRLG's major accom-
plishments was the recent issuance of a
document reflecting the best judgment
of scientists in the member agencies on
the scientific concepts and methods
useful in identifying and evaluating
substances that may pose a cancer risk
to humans. Publication of the docu-
ment represented a significant step in
the Federal Government's efforts to
assure consistent evaluation of cancer-
causing substances in the environment,
foods, consumer products, and work-
places.
The IRLG also is engaged in an ef-
fort to develop testing guidelines
acceptable to all member agencies.
Draft guidelines for a variety of health
effects and environmental tests have
already been developed and are being
reviewed. Guidelines for documenting
epidemiological studies also are being
prepared. IRLG's work in this area is
designed to reduce testing burdens im-
posed on the chemical industry by
eliminating any unnecessary differences
in methodological details that would
otherwise require duplicative testing.
IRLG has taken other significant
steps to coordinate member agencies'
work on development of rules and
regulations affecting chemical sub-
stances, compliance and enforcement
activities, research, data collection and
dissemination, and public information
and education. Cooperative activities
have been undertaken at both Head-
quarters and Regional Office levels.
International Cooperation
In addition to the United States,
several European nations and Japan
are regulating commercial chemicals.
Recognizing the need to promote effec-
tive control of chemical hazards on an
international basis while minimizing
the creation of artificial trade barriers,
EPA is actively participating in inter-
national efforts to harmonize various
aspects of the several nations'
regulatory programs. This includes par-
ticipation in the activities of the
Organization for Economic Coopera-
tion and Development (OECD) aimed
at harmonizing testing procedures, ter-
minology, and Good Laboratory Prac-
tice standards.
EPA is also participating in the
World Health Organization's (WHO)
International Program on Chemical
Safety and other WHO programs, in-
cluding the International Agency for
Research on Cancer, the Environmen-
tal Health Criteria 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 Pro-
gram (UNEP) as the U. S. national
correspondent to the International
Registry of Potentially Toxic Chemi-
cals. The International Registry, which
is part of UNEP's global environ-
mental assessment program will pro-
vide an internationally accessible data
base on chemical substances.
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Public Participation
EPA-State Cooperative
Agreements
A significant effort is being made to
encourage broad public participation in
EPA's activities under TSCA. This ef-
fort includes a program to compensate
individuals or organizations interested
in participating in specific rulemaking
proceedings, as well as a program
generally aimed at laying the ground-
work for informed public involvement
in toxic substances control activities.
Compensation
Section 6(b)(4) of the Act authorizes
the Agency to provide compensation
for reasonable expenses of participat-
ing in proceedings for the promulga-
tion of regulations affecting the manu-
facture, processing, distribution, use,
and disposal of chemicals. Compensa-
tion can be offered to participants
whose involvement would substantially
contribute to resolution of relevant
issues and whose economic interest is
small in comparison to the costs of ef-
fective participation or who does not
have adquate resources to participate.
Based on procedural rules issued
November 30, 1977, compensation was
made available for participation in the
public hearings on the Agency's pro-
posed rules prohibiting manufacture,
processing, distribution, and use of
polychlorinated biphenyls (PCBs). One
award was madeto the Center for
Occupational Hazards in New York
City, for assembling and presenting in-
formation on the use of PCBs in
microscopy.
Grants
To support a pilot program aimed at
developing and testing means of in-
volving citizens in toxic substances con-
trol activities, the Agency has made a
grant of $106,000 to 25 nonprofit
groups in the New York-New Jersey
area. Their goal is to identify ways in
which citizens can participate in the
Agency's efforts to find economically
and technologically feasible solutions
to toxic substances problems. EPA is
underwriting the various groups' ad-
ministrative expenses related to the
project; most of the work will be done
by some 500 persons participating as
volunteers. The volunteers come from
business and industry, labor and civic
organizations, environmental groups,
local government, public health profes-
sions, and colleges and universities.
Five additional grants have been
made to various national and local
groups, including the National Wildlife
Federation and the-Urban Environment
Conference, to support programs
aimed at raising the level of public
understanding of toxic substances
problems through the development of
publications and television presenta-
tions and through workshops on
specific issues.
Advisory Committee
The Administrator's Toxic Substances
Advisory Committee consists of sixteen
members who represent a broad variety
of backgrounds, interests, and exper-
tise. The Committee met six times dur-
ing 1978 to consider pending program
decisions and directions and to advise
the Administrator on policy, pro-
cedural and technical matters. Substan-
tive advice was given concerning the
proposed TSCA implementation ap-
proach, premanufacture review, work-
force development, international issues,
risk assessment procedures, and public
participation.
In August 1978, the Office of Toxic
Substances announced that it would
enter into, and provide financial sup-
port for, EPA-State cooperate agree-
ments to enable selected States to
develop and implement projects to deal
with problems created by toxic sub-
stances. A total of $3 million is
available to support such cooperative
agreements. States that enter into such
agreements must provide at least 25
percent of the cost of approved proj-
ects.
EPA expects to enter into coopera-
tive agreements with six to ten States.
Nine States submitted applications in
response to the August 1978 notice.
Those applications are being reviewed.
Any of the nine that do not receive an
award based on these applications, plus
any that apply later, will be eligible for
awards during a second selection pro-
cess scheduled for mid-1979.
The nine applications currently being
reviewed include proposals for a vari-
ety of projects, including development
of toxic substances data systems, en-
vironmental monitoring activities,
epidemiological studies, development
of toxic substances emergency response
programs, and expansion and improve-
ment of analytical capabilities.
10
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Work Force
Industry Assistance
TSCA implementation will require
both EPA and the chemical industry to
increase their employment of persons
trained in various scientific and tech-
nical professions. In some of these pro-
fessions, notably toxicology, pathol-
ogy, and epidemiology, the supply of
trained persons is already barely ade-
quate to meet government and industry
needs and will be further strained by
increasing requirements for assessment
of health hazards not only under
TSCA but also under other Federal
laws, including those dealing with
pesticides and occupational hazards.
Thus far, EPA has been able to
identify and hire qualified scientists,
even in the shortage categories. Ac-
complishing this has required extensive
recruiting efforts. In a few categories,
notably veterinary pathology, industry
salaries are sufficiently higher than
Federal salaries to force the Agency to
obtain expertise through contracts.
EPA is taking various steps to try to
improve the situation. The Agency is
working with the Office of Personnel
Management to set up a hiring register
for toxicologists; availability of such a
register would make it easier to iden-
tify and hire persons qualified in tox-
icology. Efforts are being made to im-
prove Agency's contacts with educa-
tional institutions to provide a better
basis for recruitment. The Agency is
working with various other Federal
agencies to enlist their cooperation in
allowing people trained in programs
they support to fulfill government
employment obligations by working for
EPA. Also, the Agency is working
with one university to develop a short
course that would provide specialized
training in toxicology to scientists with
appropriate backgrounds; this program
will be open to both governmental and
nongovernmental scientists.
In addition, EPA is cooperating with
the National Academy of Sciences
(NAS) in a study aimed at determining
whether increases in Federally sup-
ported training will be needed. Should
such increases be necessary, EPA
believes they should be achieved by ex-
panding existing programs, rather than
starting new ones, provided that EPA
employment is considered an appro-
priate way to fulfill trainees' obliga-
tions to the government.
In accordance with section 26 of the
Act, an Industry Assistance Office has
been established in the Office of Toxic
Substances to provide information to
the chemical industry about TSCA re-
quirements. The Industry Assistance
Office is making a significant contribu-
tion to the chemical industry's under-
standing of TSCA activities.
Assistance and information are pro-
vided by various means, including a
toll-free nationwide telephone service
(which has handled an average of 1,300
calls per month) and distribution of
TSCA rules and other documents
(averaging about 4,000 copies per
month). Three slide presentations have
been prepared and are loaned to
chemical companies. One provides an
overview of TSCA, one explained the
Agency's requirements for reporting of
information for the TSCA chemical In-
ventory, and one covers the Agency's
proposed requirements for premanu-
facture notification. During the period
for TSCA Inventory reporting, the In-
dustry Assistance Office held 32
seminars in 28 cities; more than 3,000
chemical industry personnel attended
the seminars. In addition, Industry
Assistance staff members have par-
ticipated in more than 900 meetings
with representatives of trade associa-
tions and individual chemical com-
panies.
11
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Regional Offices
Litigation
EPA's ten Regional Offices are in-
volved in various activities that con-
tribute to TSCA implementation. Ac-
tual enforcement of TSCA regulations
is among the Regional Offices' major
roles. This activity involves, among
other things, inspections of regulated
establishments subject to TSCA regula-
tions, investigations of complaints, and
development of cases for prosecution.
Over the past year, Regional Offices
also have been involved in evaluating
high-temperature incinerators and
chemical waste landfills to determine
whether they meet the Agency's PCB
disposal criteria; this effort has been
coordinated by EPA's Office of Solid
Waste. Regional Offices are now in-
volved in the Agency's nationwide ef-
fort to provide technical guidance and
support for State and local efforts to
reduce asbestos exposures in schools.
Thus far, relatively little litigation has
been brought under the act. Only two
cases have raised major issues.
In Polaroid Corp. v. Costle, No.
781133S (U.S.D.C.D. Mass.), Polaroid
Corporation filed a suit in Federal
district court challenging the adequacy
of the protection that would be pro-
vided for certain chemical identity in-
formation the corporation was required
to furnish EPA for the Chemical Sub-
stances Inventory under section 8(b) of
the Act and EPA's Inventory Report-
ing Regulations (40 CFR Part 710, 42
FR 64572, December 23, 1977) and
that it claimed as confidential business
information. On June 23, 1978, the
court denied Polaroid's request that it
be excused from reporting the identity
information but issued a preliminary
injunction ordering EPA not to dis-
close outside the Agency any informa-
tion Polaroid claimed to be confiden-
tial. The court was concerned prin-
cipally with the question of release of
confidential information to persons
outside EPA (including Congress)
without prior notice to the company
that supplied the information. On
September 8, 1978, EPA issued amend-
ments to its confidential business infor-
mation regulations (40 CFR Part 2, 43
FR 39997). Among other things, these
regulations provide substantial protec-
tion for TSCA confidential business in-
formation and provide for notice to af-
fected businesses before confidential
information is disclosed outside of
EPA. Following the issuance of these
regulations, Polaroid voluntarily with-
drew its suit, and the June 23 court
order was vacated.
The other major litigation is a peti-
tion by Dow Chemical Company in the
U. S. Court of Appeals for the Third
Circuit challenging EPA regulations
issued under section 8(d) of TSCA
(Dow Chemical Co. v. EPA, No.
78-2203). The regulations (40 CFR Part
730, 43 FR 30984, July 18, 1978) re-
quire reporting of health and safety
studies that have been conducted on
the four substances and six categories
of substances recommended by the
Interagency Testing Committee on Oc-
tober 12, 1977, for priority considera-
tion for testing under section 4(a) of
the Act. Dow alleged that the 8(d)
regulations exceed EPA's authority in
that they required, first, listing and
submittal of studies concerning a
chemical substance by persons who
manufactured or processed the chemi-
cal substance for product research and,
second, development and submittal of
studies concerning a chemical sub-
stance by persons who do not manu-
facture, process or distribute the
chemical substance. Dow also claimed
that EPA violated the Administrative
Procedure Act by promulgating final
8(d) rules containing certain provisions
not contained in the proposal. The
Agency recently revoked the rules in
question and announced its intent to
issue a new set of proposed 8(d) rules.
The Agency found the procedural
questions raised by Dow "substantial;"
however, the Agency specifically stated
its disagreement with Dow's position
on the proper interpretation of the
statute. This case is pending.
Minor cases and their dispositions
are given below:
Polaroid Corp. v. Costle, No.
78-1235 (1st Cir.)
Protective action, dismissed with
other case, cited above.
Risdon Q-Mist Corp. v. EPA, No.
78-1427 (D.C. Cir.)
Joint motion to dismiss was filed
January 12, 1979. Issue: Proper scope
of pesticide exemption in regulations
that ban most chlorofluorocarbon
aerosol uses (43 FR 11318, March 17,
1978). Exemption was modified
December 21, 1978 (43 FR 59500).
Duke Power Co. v. Costle, No.
12
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Problems
78-1239 (4th Cir.)
Dismissed September 12, 1978, by
consent. Issue: Proper interpretation of
certain provisions of the PCB disposal
regulations (43 FR 7150, February 17,
1978). Clarified by Federal Register
notice (43 FR 33918, August 2, 1978).
With TSCA, as with any major new
legislation, it has been necessary to
cope with many administrative and
managerial difficulties, including those
associated with building and housing a
new and expanding organization, iden-
tifying and hiring qualified profes-
sionals, and developing efficient
operating procedures and effective
working relationships. EPA has not by
any means resolved all such difficulties
but is making reasonable progress in
dealing with them.
To implement TSCA, it is also
necessary to resolve many complete
policy issues in areas where existing
precedents, if any, often are conflicting
or controversial and where there often
is conflict between the general public
interest in protection against unreason-
able health and environmental risks
and the chemical industry's interest in
meeting its customers' needs and mak-
ing a reasonable profit. EPA must take
these competing considerations into ac-
count in virtually all TSCA decision-
making, whether the question is how to
define "small quantities for research
and development," or how to set stan-
dards under which small chemical com-
panies would be exempt from certain
reporting and recordkeeping require-
ments, or how to ensure that importers
and domestic manufacturers are given
as equivalent treatment as possible in
rules and regulations, or whether to
adopt 500 or 50 parts per million as
the lowest level that will be subject to
the PCB regulations.
One problem that is fundamental is
the tension between EPA's needs for
scientific and other data for use in
identifying and assessing human health
and environmental risks and the chemi-
cal industry's concern about the costs
of providing such data. This is a prob-
lem EPA is facing in developing re-
quirements for testing, reporting and
recordkeeping, and premanufacture
notification. It is particularly trouble-
some in premanufacture notification,
because extensive testing of new chemi-
cal substances could inhibit innovation
in the chemical industry. EPA expects
to issue testing guidelines that will help
chemical manufacturers minimize this
effect by focusing testing resources on
those new chemicals most likely to
present significant human health or en-
vironmental risks.
Another significant problem is the
conflict between the public interest in
access to data submitted under TSCA
and the chemical industry's interest in
protecting trade secrets. For the pur-
pose of compiling the TSCA chemical
inventory, the Agency resolved this
problem by providing that chemical
identities would appear in the pub-
lished list except where a claim is made
that disclosure of the fact that a
specific chemical is being manufactured
would reveal a trade secret. In the
premanufacture program, the problem
is more complicated because other pro-
visions of TSCA have a bearing and
because chemical manufacturers are
especially interested in protecting their
competitive position during the period
leading up to actual introduction of a
new chemical substance. EPA's pro-
posed solution to the problem is
described in the Agency's proposed
rules for premanufacture notification.
As rules are written under other provi-
sions of the Act, the Agency will have
to continue to deal with the data con-
fidentiality problem.
13
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Appendix A
Principal Rules and Regula-
tions and Public Notices
1. March 9, 1977. General Provisions and Inven-
tory Reporting Requirements. 42 FR 13130. Pro-
posed rules governing reporting for the TSCA
chemical inventory.
2. April 12, 1977. General Provisions and Inven-
tory Reporting Requirements; Supplemental
Notice 42 FR 19298. Guide to the use of the can-
didate list of chemical substances.
3. April 21, 1977. Procedures for Rulemaking
under Section 6 of the Toxic Substances Control
Act. 42 FR 20640 Proposed rules.
4. May 13. 1977. Fully Halogenated Chloro-
fluoroalkanes Proposed Prohibitions and
Notice of CPSC Action. 42 FR 24536. Proposed
rules applicable to nonessential aerosol uses of
chlorofluorocarbons.
5. May 24, 1977. Polychlormated Biphenyls
(PCBs). 42 FR 26564. Proposed rules for mark-
ing and disposal of PCBs.
6. August 2, 1977. General Provisions and In-
ventory Requirements. 42 FR 26564. Reproposal
of rules governing reporting for the TSCA
chemical inventory.
7. September 9, 1977 Notification of Sub-
stantial Risk under Section 8(e). 42 FR 45362.
Proposed Guidance for reporting of "substantial
risk" information.
8. October 3, 1977. Supplemental Notice to Pro-
posed Inventory Reporting Requirements; Draft
Reporting Forms. 42 FR 53804.
9. October 11, 1977. Regulation of Toxic and
Hazardous Substances Interagency Agree-
ment. 42 FR 54856. Announcement of the for-
mation of the Interagency Regulatory Liaison
Group (IRLG).
10. October 12, 1977. TSCA Interagency Testing
Committee Initial Report to the Environmen-
tal Protection Agency. 42 FR 55026. First report
under section 4(e). Also see 42 FR 58777 for cor-
rections.
11. November 30, 1977. Compensation for
Public Participation in Rulemaking under Sec-
tion 6 of the Toxic Substances Control Act. 42
FR 60911 Temporary rules.
12. December 2, 1977. Procedures for Rule-
making under Section 6 of the Toxic Substances
Control Act. 42 FR 61259. Final rules.
13. December 23, 1977. Inventory Reporting Re-
quirements. 42 FR 64572. Final Rules.
14. January 12, 1978. Interim Procedures for
Handling Confidential Business Information. 43
FR 1836.
15. January 18, 1978. Public Information
General Provisions; Confidential Business Infor-
mation under Toxic Substances Control Act and
Solid Waste Disposal Act. 43 FR 2637. Proposed
rules under the Freedom of Information Act.
16. January 31, 1978. Proposed Rule for Health
and Safety Study Reporting. 43 FR 4073. Pro-
posed rule under TSCA section 8(d).
17. February 17, 1978. Polychlormated
Biphenyls (PCBs) Disposal and Marking. 43
FR 7150. Final rules.
18. February 17, 1978. Interagency Regulatory
Liaison Group Notice of IRLG Work Plans
and Public Meetings. 43 FR 53804.
19. March 6, 1978. Inventory Reporting Regula-
tions; Supplemental Clarification; Notice of
Meetings. 43 FR 9254.
20. March 16, 1978. Statement of Interpretation
and Enforcement Policy; Notification of
Substantial Risk. 43 FR 11110. Final guidance
under section 8(e).
21. March 17, 1978. Chlorofluorocarbons as
Propellants in Self-Pressurized Containers
Prohibition on Use. 43 FR 11301. Final rules.
22. April 3, 1978. Security of Confidential Busi-
ness Information. 43 FR 13915. Request for
public comment on security procedures manual.
23. April 17, 1978. Inventory Reporting Regula-
tions Supplemental of Clarification. 43 FR
16147.
24. April 19, 1978. Second Report of the Inter-
agency Testing Committee. 43 FR 16684.
25. June 7, 1978. Polychlormated Biphenyls
(PCBs) Manufacturing, Processing, Distribu-
tion in Commerce, and Use Bans. 43 FR 24802.
Proposed rules.
26. June 7, 1978. Guidance for reporting exports
of PCBs and Chlorofluorocarbons. 43 FR 24818.
27. July 18, 1978. Health and Safety Study
Reporting Regulations. 43 FR 30984. Final rules
under TSCA section 8(d).
28. July 25, 1978. Security of Confidential Busi-
ness Information, 43 FR 32186. Notice of avail-
ability of security procedures manual.
29. August 2, 1978 Polychlorinated Biphenyls
(PCBs) Addendum to Preamble and Correction
to Final Rule. 43 FR 33918.
30. August 4, 1978. Consolidated Rules of Prac-
tice Governing the Administrative Assessment of
Civil Penalties or the Revocation or Suspension
of Permits. Interim and Proposed Rule of Prac-
tice. TSCA section 16(a). 43 FR 34730.
31. August 16, 1978. Health and Safety Report-
ing Regulations. Corrections to final rule. 43 FR
36249.
32. August 25, 1978. Approved PCB Disposal
Facilities. 43 FR 38087.
33. August 28, 1978. Notice of availability of
funds for cooperative agreements with States. 43
FR 38466.
34. September 8, 1978. Public Information.
General Provisions; Confidential Business Infor-
mation. 43 FR 39997. Final rules under the
Freedom of Information Act.
35. September 15, 1978. Health and Safety
Study Reporting Regulations. Extension of
Reporting Deadline. 43 FR 41205.
36. September 21, 1978. Proposed exemption to
chlorofluorocarbons rule. 43 FR 42770.
37. October 24, 1978. Policy for Revised Inven-
tory Reporting; Draft Report Form. 43 FR
49687.
38. October 26, 1978. Response to Interagency
Testing Committee Recommendations (October
12, 1977). 43 FR 50133.
39. October 26, 1978. Proposed TSCA Imple-
mentation Approach; Request for Public Com-
ment. 43 FR 50139.
40. October 26, 1978. Polychlorinated Biphenyls
Notice of Approved PCB Disposal Facilities.
43 FR 50041.
41. October 30, 1978. Third Reporting of the In-
teragency Testing Committee. 43 FR 50629.
42. November 1, 1978. Interim Procedural Rules
under Section 6 for PCBs Ban Exemption. 43 FR
50905.
43. November 17, 1978. Security of Confidential
Business Information; Supplemental Clarifica-
tion. 43 FR 53817.
14
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44. November 27, 1978. Chlorofluoroalkanes
Clarification of Final Rule (March 17, 1978) 43
FR 55241.
45. December 4, 1978. Reporting of Health and
Safety Studies Denial of Citizens Petition
filed by the Manufacturing Chemists Associa-
tion. 43 FR 56724.
46. December 21, 1978. Fully Halogenated
Chlorofluoroalkanes Essential use application
exemptions for metered valve and total release
valve devices. 43 FR 59500.
47. December 20, 1978. Approved PCB Disposal
Facilities. 43 FR 59432.
48. January 10, 1979. Premanufacturing Notifi-
cation Requirements and Review Procedures. 44
FR 2241. Proposed rules.
49. January 19, 1979. Revocation of Rule
Health and Safety Study Reporting. 44 FR 6099.
Revocation of rule under section 8(d).
51. February 7, 1979. Notice of transfer of
TSCA inventory information to contractor. 44
FR 7811.
15
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