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Chemicals are all around us—in our air, our water, and ourfood,
and in the things we touch. Many of these chemicals have
become essential to our lives, and their production contributes
significantly to our national economy. However, for many of
them we have little knowledge of the ill effects they might cause
after many years of exposure The Toxic Substances Control
Act, which was signed into law in October 1976, is designed to
improve our understanding of chemicals around us and to
provide controls on those that may threaten health or the
environment
Background:
Recognizing
Chemical Risks
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There has been a dramatic surge in the development of
synthetic organic chemicals since World War II Presently there
are an estimated two million recognized chemical compounds
Chemical sales now exceed $100 billion per year, with over
30,000 chemical substances in commerce To these, a
thousand new ones may be introduced each year
Chemicals play an important role in protecting, prolonging, and
enhancing our lives Synthetic fibers are used to replace human
tissue and to create our easy-to wear wardrobe Plastics have
been molded for use in almost every phase of our activities —in
transportation, communications, and industrial and consumer
goods Our leisure time has been enhanced, for example, by
durable, low-maintenance pleasure boats and other
recreational equipment made from plastics Also, the chemical
industry makes a significant contribution to the national
economy, with sales representing more than six percent of our
Gross National Product Millions of workers are employed by the
chemical industry or chemically-dependent industries
However, while we have enioyed the extensive economic and
social benefits of chemicals, we have not always realized the
risks that may be associated with them
In the last few years, many chemicals commonly used and
widely dispersed have been found to present significant health
and environmental dangers Vinyl chloride, which is commonly
used in plastics, has caused the deaths of workers who were
exposed to it Asbestos has long been known to cause cancer
when inhaled. Mercury has caused debilitating effects in Japan
Perhaps the most vivid example of the danger of uncontrolled
chemical contaminants is the family of chemicals called
polychlonnated biphenyls, or PCB's. It was not until after tens of
millions of pounds of PCB's were produced and released into the
environment, however, that scientists realized how toxic and
persistent they were Despite limited restrictions imposed in the
early 1970's by industry to reduce the production and to restrict
use of PCB's to electrical equipment where escape to the
environment would be minimal, high levels of PCB's continue to
persist in the Great Lakes and other major waters across the
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Scope of the Law
Testing of Chemicals
Nation Over the past few years, we have found PCB's in our
bodies and even in the milk of our nursing mothers Recently,
some close relatives of PCB's, polybrommated biphenyls, or
PBB's, have posed a similarly grave threat to human health and
the environment. Accidental use of PBB's in animal feed led to
the contamination of thousands of Michigan cattle, which had to
be slaughtered The health effects of PBB's on the Michigan
farming families who were exposed to PBB's and consumed
PBB-contaminated products are still uncertain
In 1971, the President's Council on Environmental Quality
developed a legislative proposal for coping with the increasing
problems of toxic substances. Over the next five years,
Congress held many days of hearings, debated and amended
the provisions in committee, failed to resolve the differences
between the House and Senate bills in the 92nd and 93rd
Congresses, and finally enacted the present legislation in the fall
of 1976. The law grants the U S Environmental Protection
Agency (EPA) significant new authority that should greatly
improve our ability to anticipate and address chemical risks
before it is too late to undo the damage
The following sections briefly describe the major provisions of
the new law The discussion is intended to familiarize the public
with the provisions of the law but not to constitute an
authoritative legal statement of it.
The Toxic Substances Control Act authorizes EPA to obtain
from industry data on the production, use, health effects, and
other matters concerning chemical substances and mixtures. If
warranted, EPA may regulate the manufacture, processing,
distribution in commerce, use, and disposal of a chemical
substance or mixture Pesticides, tobacco, nuclear material,
firearms and ammunition, food, food additives, drugs, and
cosmetics are exempted from the Act These products are
currently regulated under other laws.
The EPA Administrator may require manufacturers or
processors of potentially harmful chemicals to conduct tests on
the chemicals, Testing may be directed to evaluate the
characteristics of a chemical, such as persistence or acute
toxicity, or to clarify its health and environmental effects,
including carcinogenic, mutagenic, behavioral, and synergistic
effects. Before requiring testing, the Administrator must set forth
the need for such testing Specifically, the Administrator must
find that (1) the chemical may present an unreasonable r isk to
health or the environment, or there may be substantial human or
environmental exposure to the chemical; (2) there are
insufficient data and experience for determining or predicting
the health and environmental effects of the chemical, and (3)
testing of the chemical is necessary to develop such data. The
manufacturers or processors of a chemical must bear costs of
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testing that chemical
Premanufacture
Notification
Testing requirements under this section must be promulgated
by regulation, after opportunity for comments and an oral
presentation at a hearing A manufacturer or processor of a
proposed new chemical may petition the Administrator to
develop testing standards for the chemical
An interagency committee of government experts on chemical
substances will advise the Administrator concerning chemicals
that should be tested, but his actions are not limited to those
recommended by the committee The eight committee
members will represent the Departments of Labor, Commerce,
Health, Education, and Welfare (including the National Cancer
Institute, the National Institute for Occupational Safety and
Health, the National Institute of Environmental Health Sciences);
the National Science Foundation; the Council on Environmental
Quality; and EPA The committee may designate, at any one
time, up to 50 chemicals from its list of recommended
substances for testing. Within one year, the Administrator must
either initiate testing requirements for those designated
chemicals or publish in the Federal Register his reasons for not
initiating such requirements
Manufacturers of new chemical substances must give the
Administrator 90 days notice before the manufacture of the
chemicals Any chemical which is not listed on an inventory of
existing chemicals to be published by the Administrator
will be considered "new" for purposes of the premanufacture
notice requirement.
The Administrator may designate a use of an existing chemical
as a significant new use, based on consideration of the
anticipated extent and type of exposure to human beings or the
environment Any person who intends to manufacture or
process a chemical for such a significant new use must also
report 90 days before manufacturing the chemical for that use
In both of the above cases, the Administrator may extend the 90-
day premanufacture review period for an additional 90 days for
good cause
Notices submitted by the manufacturers for new chemicals or
significant new uses of existing chemicals are to include the
name of the chemical, its chemical identity and molecular
structure, proposed categories of use, an estimate of the
amount to be manufactured, the byproducts resulting from the
manufacture, processing, and disposal of the chemical, and any
test data related to the health and environmental effects which
the manufacturer has. In addition, if a rule requiring testing of the
chemical or members of its chemical class has been
promulgated, the manufacturer must submit test data developed
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from that testing along with the other information
The Administrator may publish a list of new chemicals or
classes of new chemicals that present or may present an
unreasonable risk of injury to health or the environment if they
are introduced into commerce When a manufacturer of a new
chemical which is on that list submits his premanufacture
notice, he must submit data which he believes show that the
chemical will not present such a risk
The Administrator may determine that there is inadequate
information to evaluate the health or environmental effects of a
new chemical whether or not it is on the list described above In
that event, he may issue an order 45 days before the expiration
of the premanufacture review period to prohibit or limit the
manufacture, processing, distribution in commerce, use, or
disposal of a chemical pending acquisition of additional data. If
the manufacturer files objections to the order, the Administrator
may seek a court injunction to prevent manufacturing of the
chemical until data are developed which indicate that the
substance does not present an unreasonable risk
The Administrator may find that there is a reasonable basis to
conclude that a new chemical presents or will present an
unreasonable risk of injury to health or the environment. In that
event, he may follow similar procedures involving an order, and,
if appropriate, court action to prohibit the manufacture of the
chemical. If a total ban does not appear necessary, the
Administrator may propose a rule that becomes immediately
effective limiting the manufacture or use of a proposed chemical
or regulating its distribution in commerce, use, or disposal
For certain new chemicals, the Administrator must publish his
reasons in the Federal Register if he does not initiate regulatory
action during the premanufacture review period These include
chemicals subject to testing requirements, those listed by the
Administrator as possibly presenting an unreasonable risk,
and chemicals whose use was designated as a significant
new use
Exempt from the premanufacture notification requirement are
chemicals. (1) included in categories of chemical substances
listed on the inventory of existing chemicals, (2) produced in
small quantities solely for experimental or research and
development purposes; (3) used for test marketing purposes;
and (4) determined by the Administrator not to present an
unreasonable risk A person must apply for an exemption
described by (3) and (4) on a chemical-by-chemical basis
In addition, a person may apply for an exemption from
premanufacture notification requirements if a chemical exists
only temporarily and there is or will be no human or
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environmental exposure This exemption is directed to
chemicals which exist as the result of a chemical reaction in the
manufacture or processing of a mixture or another chemical
substance
Regulation of
Hazardous Chemical
Substances and
Mixtures
The Administrator may prohibit or limit the manufacturing,
processing, distribution in commerce, use, or disposal of a
chemical substance or mixture if he finds that these activities or
any combination of them presents or will present an
unreasonable risk of injury to health or the environment.
Labeling may be required for a chemical or any article
containing the chemical. A manufacturer may be required to
make and keep records of the processes used in manufacturing
a chemical and to conduct tests to assure compliance with any
regulatory requirements Further, the Administrator may require
a manufacturer to give notice of any unreasonable risk of in,ury
presented by his chemical to those who purchase or may be
exposed to that substance. A manufacturer also may be
required to replace or repurchase a substance which presents
an unreasonable risk
In proposing regulatory actions, the Administrator must provide
an opportunity for comments by all interested parties, including
an oral presentation at a hearing, and in certain circumstances,
cross-examination For those unable to afford the costs of
participating inrulemaking proceedings, the Administrator may
provide compensation
A rule limiting, but not banning, a chemical may become
immediately effective when initially proposed in the Federal
Register if the Administrator determines that the chemical is
likely to present an unreasonable risk of serious or widespread
injury to health or the environment before normal rulemaking
procedures could be completed However, in the case of a rule
prohibiting the manufacture of the chemical, the Administrator
must first obtain a court injunction before a rule can be made
immediately effective
If a chemical contains a hazardous contaminant as the result of
a certain manufacturing process, the Administrator may order
the manufacturer to change his process to avoid such
contamination. If a chemical contains a contaminant which
may present an unreasonable risk of injury to health or the
environment, the manufacturer may be required to give public
notice and to repurchase or recall the product.
In addition, the law requires that the Administrator take action
to regulate polychlorinated biphenyls, by issuing labeling and
disposal regulations by July 1977, restricting the chemical's
use to closed systems by January 1978, prohibiting all
production by January 1979, and distribution in commerce by
July 1979.
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Record-Keeping
and Reporting
Relationship to
Other Federal Laws
For those chemicals that present an imminent and
unreasonable risk of serious or widespread injury to health or
the environment, the Administrator may ask a court to require
whatever action may be necessary to protect against such risk
The law authorizes the Administrator to issue rules requiring
manufacturers and processors of selected chemicals to report
to EPA the name of each chemical, its identity, its proposed
uses, estimates of production levels, description of byproducts,
adverse health and environmental data, and number of workers
exposed to the chemicals Manufacturers of chemical mixtures
and research chemicals are exempt from these requirements
unless the Administrator determines such reporting is
necessary to enforce the Act Similarly, in the absence of a
determination that reporting is necessary because of an
unreasonable risk, small manufacturers are exempt from
reporting except for chemicals that are subject to proposed or
promulgated testing requirements or limitations under the
regulatory provisions of the Act
The Administrator is required to publish a list of all existing
commercial chemicals. This list, which will be published initially
by fall 1978 and updated thereafter, will contain all chemicals
manufactured or processed for commercial purposes in the
United States or imported into the United States within the last
three years
The law requires any person who manufactures, processes, or
distributes in commerce any chemical substance or mixture to
keep records of significant adverse reactions to health or the
environment that allegedly were caused by the chemical
Records concerning health effects on employees must be kept
for 30 years, other records for five years
The Administrator may request any health and safety studies
on specific chemicals known or available to any person who
manufactures, processes, or distributes such chemicals in
commerce. In addition, if such a person has information which
indicates that a chemical presents a substantial risk of injury to
health or the environment, he must notify the Administrator
The Administrator may determine that an unreasonable risk
presented by a chemical may be prevented or sufficiently
reduced by action under a Federal law not administered by
EPA If he does, the Administrator will request the agency
administering the other law to determine whether the risk exists
and if the agency's action would sufficiently reduce the risk If
the agency finds no risk or takes action directed to the risk,
EPA may not take any regulatory action directed to the same
risk
The law directs the Administrator to use other laws
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administered by EPA to protect against unreasonable risks,
such as the Federal Water Pollution Control Act or the Clean
Air Act, unless the Administrator determines that it is in the
public interest to protect against such risks under the Toxic
Substances Control Act
Disclosure of Data
Civil and Criminal
Penalties
Effect on State Laws
Actions by Citizens
Exports and Imports
Confidential data, such as trade secrets and privileged
financial data, will be protected from disclosure by the
Administrator All health and safety information on chemicals in
commerce submitted under the Act is subject to disclosure A
person submitting other types of data to EPA may designate
any part of it as confidential. If the claims of confidentiality are
subject to question or if the release of such data is essential for
the protection of health or the environment, the Administrator
shall notify the person who submitted the data in advance of
any contemplated release
Any person who fails or refuses to comply with any
requirement made under the law may be fined up to $25,000 for
each day of violation of the law Persons who knowingly or
willfully violate the law, in addition to any civil penalties, may be
fined up to $25,000 for each day of violation, imprisoned up to a
year, or both
With certain exceptions, as set forth below, the Act will not
affect the authority of any State or political subdivision to
establish regulations concerning chemicals. If EPA issues a
testing requirement for a chemical, a State may not establish a
similar one If EPA restricts the manufacture or otherwise
regulates a chemical under the Act, a State may only issue
requirements which are identical, mandated by other Federal
laws, or prohibit the use of the chemical. In response to a
request by a State, the Administrator may grant an exemption
under certain conditions. Specifically, the Administrator may
grant exemptions if the State requirement (1) would not cause
a person or activity to be in violation of a requirement unde^r the
Act, and (2) would provide a greater degree of protection and
not unduly burden interstate commerce.
Any person may bring a civil suit to restrain a violation of the
Act by any party or to compel the Administrator to perform any
nondiscretionary duty required by the Act. In addition, any
person may petition the Administrator to issue, amend, or
repeal a rule under the testing, reporting, or restriction sections
of the Act. The Administrator has 90 days to respond to a
petition. If he takes no action or denies a petition, the parly has
the opportunity for judicial review in a U.S district court In both
civil suits and citizens' petitions, the court may award
reasonable legal costs and attorney fees if appropriate.
In the case of a chemical produced for export that presents an
unreasonable risk to health or the environment of the United
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Research,
Monitoring, and
Data Systems
States, the Administrator may regulate the chemical He may
also require testing of any exported chemical if such testing is
necessary to determine whether there is such a risk to the
United States If a person is exporting, or intends to export, a
chemical for which data are required to be submitted under the
testing or manufacturing notification sections, he must notify
the Administrator. The Administrator is responsible for notifying
the governments of the importing countries of the availability
of such data. Similarly, if a person is exporting a chemical
subject to a regulatory order or action, he must notify the
Administrator who in turn will notify the appropriate
governments
With respect to imports, no chemical substance, mixture, or
article containing a chemical substance or mixture will be
allowed into the customs territory of the United States if it fails
to comply with any rule or is otherwise in violation of the Act
There are several provisions in the Act that call for expanded
research and related activities by EPA and other Federal
agencies. The Administrator, in consultation with the Secretary
of Health, Education, and Welfare (HEW), may enter into
contracts and make grants for research, development, and
monitoring In addition to establishing a data system within EPA
for data submitted under the Act, the Administrator is
responsible for designing and establishing a system for
lexicological and other scientific data accessible to all Federal
agencies The Council on Environmental Quality is responsible
for studying standard classification and storage systems for
chemical substances.
Other research required by the Act to be conducted by the
Administrator in consultation with the Secretary of HEW
concerns techniques for screening chemical effects and for
monitoring chemicals In addition, the Secretary of HEW has
special responsibility related to inexpensive and efficient
methods for determining the health and environmental effects
of chemicals
State Programs
The Act authorizes $1.5 million each year for grants to assist
States to prevent or eliminate risks associated with toxic
substances when the Administrator is unable to take action
The amount of the grant shall be no greater than 75 percent of
the costs of the program In awarding grants, the Administrator
shall take into account the seriousness of the health effects
that are associated with the chemical substances and the
extent of human and environmental exposure to them in the
State.
Enforcement of
the Act
For purposes of administering the Act, the Administrator or his
representative may inspect any establishment in which
chemicals are manufactured, processed, stored, or held before
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Judicial Review
Employee
Protection
Administration
of the Act
or after their distribution in commerce No inspection shall
include financial, sales, pricing, personnel, or research data
unless specificed in an inspection notice
The Administrator may subpoena witnesses, documents, and
other information as necessary to carry out the Act.
Civil actions concerning violations on lack of compliance with
the Act may be brought in a U S district court for judicial
review Any chemical substance or mixture that was
manufactured, processed, or distributed in commerce in
violation of the Act may be subject to seizure
Not later than sixty days after a rule is promulgated, any person
may file a petition for judicial review of such rule with the U S
Court of Appeals for the District of Columbia Circuit or with the
U S. Court of Appeals for the circuit of his residence or business.
If an employee believes that his employer has discriminated
against him because of the employee's participation in carrying
out the Act, he may file a complaint with the Secretary of Labor
The Secretary shall investigate the alleged discrimination and,
if warranted, may order the employer to remedy the effects of
any such discriminatory action Employees and employers may
obtain judicial review in the U.S Courts of Appeals
The Administrator will evaluate the potential effects on
employment of regulatory actions under the Act In response to
a petition by an employee, the Administrator may investigate
and hold public hearings concerning job losses or other
adverse effects allegedly resulting from a requirement under
the Act The Administrator will make public his findings and
recommendations
There are several provisions that deal with general
administration of the Act. Among them is a provision
authorizing the Administrator to require fees to defray the cost
of reviewing testing data and premanufacture notifications.
Such fees shall not exceed $2,500 or, in the case of small
business concerns, $100
As required by the Act, EPA has established an office to
provide technical and other nonfinancial assistance to
manufacturers and processors respecting the requirements
of the Act
Finally, the Administrator will waive compliance with any
provision of the Act if requested by the President for national
defense purposes
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Further Information Single copies of the Toxic Substances Control Act and of this
brochure are available without charge from the Printing
Management Office (PM-215), Environmental Protection
Agency, Washington, D C 20460
EPA Regional
Offices
Regional Offices
EPA Region 1
Room 2303
JKF Federal Building
Boston, MA 02203
EPA Region 2
Room 1005
26 Federal Plaza
New York, NY 10007
EPA Region 3
Curtis Building
6th and Walnut Streets
Philadelphia, PA 19106
EPA Region 4
345CourtlandSt, NE
Atlanta GA 30308
EPA Region 5
230 South Dearborn Street
Chicago, IL 60604
EPA Region 6
1201 ElmSt
Dallas, TX 75270
EPA Region 7
1735 Baltimore Street
Kansas City, MO 64108
EPA Region 8
Suite 900
1860 Lincoln Street
Denver, CO 80203
EPA Region 9
100 California Street
San Francisco, CA 94111
EPA Region 10
1200 Sixth Avenue
Seattle, WA98101
States Covered
Connecticut, Maine
Massachusetts, New
Hampshire, Rhode Island,
Vermont
New Jersey, New York,
Puerto Rico, Virgin Islands
Delaware, Maryland
Pennsylvania, Virginia,
West Virginia, District of
Columbia
Alabama, Georgia, Florida,
Mississippi, North Carolina,
South Carolina, Tennessee,
Kentucky
Illinois, Indiana, Ohio,
Michigan, Wisconsin,
Minnesota
Arkansas, Louisiana,
Oklahoma, Texas, New
Mexico
Iowa, Kansas, Missouri,
Nebraska
Colorado, Utah, Wyoming,
Montana, North Dakota,
South Dakota
Arizona, California, Nevada,
Hawaii
Alaska, Idaho, Oregon,
Washington
.. ) S Environmental Protection
i-n 5 Library (PL-12J)
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•ff U.S. GOVERNMENT PRINTING OFFICE : 1977 O—247-301
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