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5076
United States
Environmental Protection
Agency
Toxic Substances
September 1979
905R79114
&EPA The Toxic
Substances
Control Act:
An Overview of Its
Authorities and
Major Activities
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Foreword
This handbook has been prepared by the U.S. Environmental Protec-
tion Agency's Industry Assistance Office established under the Toxic
Substances Control Act of 1976 (TSCA) (Public Law 94-469).
It describes the four major activities around which EPA's TSCA au-
thorities center:
• To gather information on chemicals;
• To require testing of chemicals identified as possible risks;
• To screen new chemicals proven to present a risk;
• To control chemicals proven to present a risk.
Within each of these four areas of authority EPA has made a great deal
of progress towards TSCA's implementation. This handbook cap-
sulizes this progress: explaining what the Chemical Substance Inven-
tory is; what the difference between "existing" and "new" chemicals
are under TSCA; what premanufacture notification means; the first
chemicals recommended for priority testing; what existing health and
safety data EPA can request from industry; what chemicals are already
being regulated under TSCA . . . and much more.
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&EPA The Toxic
Substances
Control Act:
An Overview of Its
Authorities and
Major Activities
taJ Protection A
V, Library
30 South Dearborn ^xfr
ecxvx
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We live in a world in which we are surrounded by chemicals. The air we
breathe, and almost everything we touch, eat, or drink contains them.
Chemical products protect and enhance our lives and the environ-
ment. They are essential to modern life. Yet, we know too little about
what effects many chemicals may have on human health and the
environment.
Out of this concern, the Toxic Substances Control Act—known as
TSCA—was enacted in 1976. Now for the first time the entire chemical
industry serving the United States is subject to broad-based Federal
regulation. TSCA gives the Environmental Protection Agency—
E.P.A.—a broad mandate to protect public health and the environment
from unreasonable chemical risks—to gather information on chemi-
cals, to identify harmful substances, and to control those substances
whose risks outweigh their benefits to society and the economy.
Although TSCA is a complex law, its basic purpose is simple: to
prevent unreasonable chemical risks. It gives EPA the authority to act
before harmful chemical substances threaten human health or the
environment.
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In May 1977, President Carter stressed the need for TSCA's preventive
approach in his environmental message to Congress. He said, "The
presence of toxic chemicals in our environment is one of the grimmest
discoveries of the industrial era. Rather than coping with these hazards
after they have escaped into our environment, our primary objective
must be to prevent them from entering the environment at all."
Today more than 44,000 chemicals are made or imported for commer-
cial purposes in the United States. Furthermore, several hundred new
chemical substances may be introduced into commerce annually.
Therefore, the universe of chemical substances potentially subject to
TSCA is enormous . . . and growing all the time.
Eight product categories are exempt from the law's authority: tobacco,
nuclear material, firearms and ammunition, substances used solely as
pesticides, food, food additives, drugs, and cosmetics. These fall
under the jurisdiction of other Federal laws.
TSCA is not the first Federal law to address the serious health and
environmental problems associated with toxic chemicals in our soci-
ety. Unlike TSCA, however, the other laws largely enable the govern-
ment to take action only after widespread exposure and possibly
serious harm have occurred. TSCA also fills a number of significant
gaps that exist in the other laws.
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Under TSCA, EPA's authorities center around four major activities.
First, to collect basic information on chemical substances from manu-
facturers and processors—including importers. Second, to identify
potentially harmful substances—and require that industry test them
for adverse health and environmental effects. Third, to review all new
chemicals for potential health and environmental risks before they are
manufactured domestically for commercial purposes or imported into
the United States. And fourth, to control unreasonable risks stemming
from the manufacture, processing, distribution, use and disposal of a
chemical substance.
EPA's first major action under TSCA has been to assemble the nation's
most comprehensive Inventory of existing chemical substances in
U.S. commerce.
The Agency also has collected, for the first time, information on where
these chemicals are manufactured and in what quantities. With this
information, EPA can begin to select chemical substances for attention
and action under TSCA. The information can also be useful, to pro-
grams under other toxics-related laws, and enables EPA and others to
respond far better to chemical emergencies.
Another important reason EPA has compiled this Inventory is to de-
lineate, for TSCA implementation purposes, between "existing"
chemicals and "new" ones.
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In December 1977, TSCA Inventory reporting regulations appeared in
the Federal Register. The regulations set up a 2-phase reporting
period. The first phase, now over, called for chemical manufacturers
and importers to report chemicals they manufactured, or imported in
bulk, for a commercial purpose since January 1, 1975. For over one
year EPA compiled these submitted reports . . . which in turn, led to the
June 1, 1979 publication of the Initial Chemical Substance Inventory.
Listed on this Inventory is approximately 44,000 chemical substances
which are manufactured or imported for a commercial purpose in the
U.S.
The Initial Inventory's publication triggered the second reporting
phase of 210 days—from June 1 through December 31, 1979. During
this time, processors—those who buy, use, or distribute chemicals
from manufacturers or importers—are to reviewforcompletionthe list
of chemicals reported to EPA by their suppliers and add any chemicals
not there, which have been processed for a commercial purpose since
January 1,1975. Also, before, December 31,1979, importers of chemi-
cal substances, which are part of a mixture or an article, should check
the Initial Inventory and report to EPA any eligible chemicals which
were not included. The reported additions will be incorporated into the
Initial Inventory. A Revised Chemical Substance Inventory will be pub-
lished in 1980.
The Inventory is not a list of hazardous or toxic chemicals. Rather, it is a
list of all chemicals that were manufactured, imported or processed for
a commercial purpose since January 1, 1975.
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Some information submitted for the Inventory is entitled under TSCA,
to confidential treatment. Persons reporting forthe Inventory, whether
during the initial or now during the revised Inventory reporting phase,
are entitled to make confidential claims for the handling of information
submitted to EPA. If the chemical identity is claimed confidential, a
generic term is to be submitted by the reporter. If EPA approves the
claim, the generic name is listed in an appendix to the Inventory. The
specific chemical identity would not be publicly disclosed.
EPA has developed strict security procedures to safeguard confidential
business information, obtained under TSCA, from unauthorized dis-
closure. These procedures are in the "TSCA Confidential Business
Information Security Manual"—published in September 1978 and
available from EPA.
A second major activity, under TSCA, is to require testing of potentially
hazardous chemicals by their manufacturers and processors. These
data will be used by EPA to determine if the manufacturing, process-
ing, distribution in commerce, use or disposal of these chemicals do,
or do not, present an unreasonable risk to human health or the envi-
ronment.
The required testing of a chemical could be to determine certain
characteristics that are indicative of the risk it may present—such as its
persistence, environmental fate, and ecological effects. Testing could
also be required to determine specific health effects of the chemical-
such as, its carcinogenicity, mutagenicity, teratogenicity, or behavioral
toxicity.
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EPA proposed on May 9,1979 the first testing standards for oncogenic-
ity, and other chronic effects, as well as for good laboratory practices
concerning health effects testing. The remaining health effects
standards—acute and subchronic toxicity, mutagenic effects,
teratogenic reproductive effects, and metabolism studies—were pro-
posed on July 26,1979. The first environmental testing standards will
be proposed in late 1979.
A chemical will be selected for testing because available data on its
effects show that it may present an unreasonable risk, or because the
chemical is known to have substantial human exposure or environ-
mental release. In either case, EPA must show both that existing data
on the chemical's effects are insufficient for determining the risk, and
that testing is necessary to develop the needed data.
In requiring testing, EPA must identify the chemical to be tested,
specify the standards for development of the test data, and indicate the
time period within which the test results are to be submitted to EPA. In
determining these testing rules, EPA must consider the relative cost
factors of the various protocols that could be used to develop the
needed data, and also the foreseeable availability of test facilities and
personnel for performing the tests.
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Identifying chemicals for testing is one of EPA's major tasks under
TSCA. To complement this effort, TSCA established the Interagency
Testing Committee to recommend chemicals to EPA for priority test-
ing. The ITC, formed in February 1977, includes representatives of
eight Federal Agencies.
The ITC can designate a priority list
of up to 50 chemicals for special
consideration by EPA. Within 12
months of an ITC recommendation,
EPA must either initiate rulemaking
proceedings to require testing, or
publish reasons for not doing so. In
selecting chemicals for the priority
list, the ITC is to consider the extent
of human exposure and environ-
mental release of the chemicals, as
well as all available information on
their health and environmental ef-
fects. TSCA directs the Committee to
give special attention to chemicals
known or suspected of causing
cancer, gene mutations, or birth de-
fects.
Chemicals Recommended for
Priority Testing by ITC
Acetonitnle
Acrylamide
Alkyl epoxides
Alkyl phthalates
Aniline and bromo, chloro, and/or nitroani-
lines
Antimony (metal)
Antimony sulfide
Antimony trioxide
Aryl phosphates
Chlorinated benzenes, mono- and di-
Chlormated benzenes, tri-, tetra- and penta-
Chlormated naphthalenes
Chlorinated paraffins
Chloromethane
Cresols
Dichloromethane
1,2-Dichloropropane
Cyclohexanone
Glycidol and its denvates
Halogenated alkyl epoxides
Hexachloro-1,3-butadiene
Hexachlorocyclopentadiene
Isophorone
Mesityl oxide
4,4'-Methylenedianilme
Methyl ethyl ketone
Methyl isobutyl ketone
Nitrobenzene
Polychlormated terphenyls
Pyndme
Toluene
1,1,1-trichloroethane
Xylenes
The ITC published its initial priority
list in the Federal Register in October
1977. Four individual chemicals and
six chemical categories were rec-
ommended. Since then the Commit-
tee has amended the initial priority
list with three additional reports-
recommending that 16 more in-
dividual chemicals and 7 categories
be considered for priority testing.
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EPA plans to propose the first health
effects testing rule in December 1979
for some of the chemicals and
groups of chemicals recommended
by the ITC. Chemicals selected
through EPA's own process and
other sources, of course, also will be
subject to testing rules.
Under TSCA, EPA also has broad au-
thority to require that chemical
manufacturers report certain kinds
of information, and maintain rec-
ords, on the hazards of particular
substances.
In March 1978 a general policy statement was issued concerning
TSCA's substantial risk notification procedures—requiring anyone
who has information, which reasonably concludes that a chemical
substance presents a substantial risk of injury to health or the
environment—to immediately notify EPA.
In July 1978, EPA published its first rule to obtain copies or lists of
health and safety studies from any person who manufactures, pro-
cesses, or distributes certain chemical substances identified in the
Interagency Testing Committee's first report. The studies submitted
were those initiated, conducted, or simply known about by a person.
In late 1979, the Agency will propose procedures for submitting health
and safety studies. This rule, to be finalized by mid-1980, will serve as a
model for health and safety study submission requirements for chem-
icals selected by the Agency for evaluation for testing rules or other
regulation.
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SIGNIFICANT ADVERSE
REACTION RECORDS
30YRS
5YRS
In mid-1980 EPA will publish rules requiring manufacturers, pro-
cessors, and distributors to keep records of "significant adverse re-
actions" to health and the environment alleged to have been caused
by a chemical substance. Under the law, records of alleged employee
health effects must be kept for 30 years. All other records of alleged
adverse reactions—including consumer and environment effects-
must be kept for 5 years. The proposed version of these rules is to be
out late in 1979.
Also, to be proposed in late 1979, are rules under which chemical
manufacturers and processors can be required to maintain and report
information on the identity, structure, uses, worker exposure and other
factors of a chemical needed to identify and assess potential problems
and support control actions under TSCA or other federal laws.
EPA's third major activity, under TSCA, concerns the important pre-
manufacture notification program—wn\ch began in July 1979. This
"screening" process requires some fundamental changes in the way
the chemical industry has operated in the past.
The premanufacture notification review process concerns "new"
.chemical substances only. New chemical substances are those not
listed on the Inventory. Implementation of premanufacture notification
is staggered—due to the two-phase reporting method used for the
Inventory collection.
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Manufacturers of new chemical substances, and importers of new
chemical substances in bulkform—that is, substances not listed on the
Initial Inventory—became subject to premanufacture notification re-
quirements on July 1, 1979. Proposed premanufacture notification
regulations were published in the January 10, 1979 Federal Register.
The number and nature of comments received on these proposed
rules delayed EPA from publishing final regulations by July 1, 1979.
Therefore, interim premanufacture notification procedures appeared
in the May 15,1979 Federal Register. Manufacturers and importers of
new chemical substances are to follow these, beginning July 1, until
the final rules are released and become effective.
Importers of new chemical substances in mixtures become subject to
premanufacture notification requirements 30 days after the 1980 Re-
vised Inventory's publication. Importers of new chemical substances
in articles are not now covered under TSCA's premanufacture notifica-
tion procedure. And, afterthe Revised Inventory is published in 1980, it
will be unlawful for persons to knowingly process or use for a com-
mercial purposes "new" substance which hasnotfirst passed through
premanufacture notification. Note that processors, themselves, are
not subject to premanufacture notification—but they cannot know-
ingly use for a commercial purposes substance that a manufacturer or
importer has not first put through TSCA's premanufacture notification
review procedure.
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FEDERAL RE6ISTER
••••••••
FEPERAL
•••BBB
FEDERAL REGISTER
Certain information is required to be submitted with all preman-
ufacture notices for the 90-day review by EPA: the common or trade
name; the chemical identity and molecular structure; estimated pro-
duction amounts; proposed use categories; methods of disposal;
workplace exposure levels; and a description of byproducts, im-
purities and other related products. Also, all test data on health and
environmental effects related to the manufacture of the substance
within the submitter's possession and control, as well as, a description
of known or reasonably ascertainable data is required.
EPA cannot require all manufacturers of all new chemicals to generate
new test data for a premanufacture notice. EPA, however under TSCA,
can require testing for selected chemicals for reasons mentioned
earlier—such as insufficient risk evaluation data. If EPA imposes such a
requirement, the test data must be submitted with the premanufacture
notice. If EPA does not impose such a testing requirement, specific
testing is then not required.
Immediately upon receipt of a premanufacture application, EPA must
publish notice of its receipt in the Federal Register. For "good cause,"
such as the need for more data, EPA can order the notification period
extended up to an additional 90 days. The review period would then
become 180 days.
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If the Agency issues an order regulating a substance because not
enough information on health and environmental effects has been
submitted—even afterthe extended review period—and the manufac-
turer objects to the order, EPA can go to a Federal District Court and
seek an injunction. The injunction would limit the commercial use of a
chemical substance, named in a premanufacture notice, until suffi-
cient data is received to evaluate the risk to health and the environ-
ment.
EPA's fourth major activity, under TSCA, is to control chemical sub-
stances found to pose an unreasonable risk to human health or the
environment. EPA may prohibit or limit the manufacture, processing,
distribution in commerce, use, or disposal of a chemical. Action under
TSCA can range from a complete ban to a simple labeling requirement.
When EPA proposes restrictive regulations on a substance, it must
also publish the basis for action in the Federal Register: the effects and
exposure amounts to human health and the environment; the use
benefits and availability of substitutes; and the economic conse-
quences of such a ruling on the national economy, small business, and
technical innovation.
Although there are many other candidates for attention, the only class
of chemicals actually named in TSCA for regulation and eventual
banning is polychlorinated biphenyls. PCBs are potentially harmful
because once released into the environment they do not break apart
into new chemical arrangement. In addition, PCBs tend to accumulate
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in the tissues of living organisms. This means as PCBs move up in the
food chain towards man theirconcentration increases. Tests show that
PCBs cause, among other things, reproductive failures, gastric disor-
ders, skin lesions, and tumors in laboratory animals.
On May 31,1979 EPA published the Final PCB Ban Rule. Effective as of
July 2, 1979, this regulation bans, with certain exceptions, the man-
ufacture, processing, distribution and use of PCBs in other than a
totally enclosed manner.
Examples of totally enclosed PCB uses, allowed to continue after July
2, are television sets, air conditioners, and microwave ovens. These
items contain PCB components, such as PCB capacitors, but their
normal continued use will not result in any exposure to human beings
or their environment.
EPA and TSCA also played a major role, along with the Food & Drug
Administration and the Consumer Product Safety Commission, in
issuing a rule which prohibits chlorofluorocarbons to be used in
aerosol products. This action was taken on the basis of evidence that
CFCs are depleting the stratospheric ozone layerthat protects the earth
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15
against damaging ultraviolet radiation from the sun. It is this radiation
which has been correlated with skin cancer in humans, and adverse
effects to plants and animals. EPA is currently investigating whetherto
proceed with additional regulation of nonaerosol uses of CFCs, includ-
ing their use in refrigeration and cooling systems, in the manufacture
of foamed material, and as solvents. If a decision is made to further
control CFCs, the regulations will be issued under the Clean Air Act,
rather than TSCA.
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In summary, in its first 3 years the Agency has taken a number of major
steps to implement TSCA . . . but much important work remains
ahead. Polychlorinated biphenyls and chlorofluorocarbons are now
being regulated under TSCA rules. In the future, other chemicals that
pose unreasonable risks to health and environment also will be. Prior-
ity testing is being planned for those chemicals about which we know
too little. Much important information on chemicals manufactured and
imported for commercial purposes has been centrally compiled. The
Initial Chemical Substance Inventory was published in June 1979, and
its revised edition will be out in 1980. And a procedure began in 1979, to
evaluate new chemicals before they enter into commercial use. Manu-
facturers and importers of new chemicals became subject to interim
premanufacture notification procedures on July 1,1979.
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TSCA provides the opportunity to better understand the chemicals
around us. It also protects the public from unreasonable health and
environmental risks. But these goals cannot be achieved in a "vac-
uum."Consideration also must be given to the continued vitality of our
nation's chemical industry.
Thus, in order for TSCA to work, and work effectively, it will take the
cooperative efforts of industry, government and the public. We all want
essentially the same thing—and it happens to be the mandate of the
Toxic Substances Control Act—for the chemicals we continue to use
and produce, and for those which are newly introduced, to be as safe
as possible.
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To obtain copies of any of the publications referenced in this handbook
or for further information on TSCA contact the Industry Assistance
Office within EPA by ...
Calling toll free: 800-424-9065
(in Washington, D.C.-554-1404)
or
write to: Industry Assistance Office
Office of Toxic Substances (TS-799)
U.S. Environmental Protection Agency
401 "M" Street, S.W.
Washington, D. C. 20460
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