July 1980
The
Toxic Substances
Control Act
Protecting People
and the Environment
from Dangerous
Chemicals
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ntroduction
Chemistry has indeed given us
"better things for better living," as
proclaimed a few years ago in a
popular advertising slogan.
Chemicals—those found in nature
and those created in laboratories-
are at the heart of our highly
industrialized, technology-based
society. They help to protect our
health, and to fend off pests.
Chemicals help clothe, shelter, and
feed us. They are found in
innumerable products for our
homes, businesses, and industry.
Chemicals are everywhere—in the
air we breathe, in the water we
drink, in the food we eat, in the
plastics, drugs, paints, pesticides,
fertilizers, fibers, dyes, detergents,
perfumes, explosives, insulation,
pipes, phonograph records, and
other products we use.
In brief, chemicals are a vital part
of our lives; they protect, enhance,
and prolong it. And chemicals are a
vital part of our national economy:
sales of chemicals and allied
products in the United States now
exceed $146 billion a year, and
chemical companies employ some
1.1 million people.
But some chemicals are dan-
gerous—toxic, They can cause
illness, and can kill people and other
living organisms. Some can harm
right away, when inhaled,
swallowed, or brought into contact
with the skin. Others take their toll
over time, affecting the nervous
system, causing cancer, birth
defects, or genetic mutation—per-
haps years after exposure to the
substance occurred. Some chemicals
are nondegradable, persisting
indefinitely in nature; these can
accumulate in living things, and
work their way into the food chain.
Of course, not all chemicals fit
into one of these toxic categories.
Many are perfectly safe to humans
and the environment if used prop-
erly. But what about the rest? Which
are of concern and why? Where are
they found, and how are people and
the environment exposed to them?
Many of these questions cannot yet
be answered—and therein lies the
enormous task facing our society
today in coming to grips with the
role that chemicals play ... for
better or worse ... in each of our
lives.
Nearly 20,000 chemical com-
pounds may pose some kind of
potential toxic risk to human health
or the environment. Evidence exists
showing that hundreds of these may
cause cancer in humans. Because
cancer is America's second leading
cause of death, topped only by heart
disease, much public attention has
been focused in recent years on the
relationship between chemicals and
cancer. While other factors such as
cigarette smoking, diet, and con-
sumption of alcoholic beverages also
are involved, there is little question
that exposure to chemicals—on the
job, in our water supplies, in the air
we breathe, in the cosmetics we
use, and in the food we eat—plays
an important role in contributing to
our country's alarming cancer rate.
In recent years, there has been a
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seemingly unending series of tragic
developments involving toxic sub-
stances. Consider the following
examples:
Asbestos
Asbestos once was considered a
health risk only for workers who
handled it. Now it is known to be a
potential hazard to the health of
millions of people, on and off the
job, who are routinely exposed to
asbestos fibers in the air they
breathe. Among those whose health
may be endangered are children,
teachers, and others in schools
where asbestos was sprayed or
troweled on ceilings, rafters, beams,
and other structural building parts
for fire-proofing, insulation, sound-
deadening, or decoration.
Asbestos fibers are chemically
inert and heat resistant, and they
cannot be destroyed. These char-
acteristics have made asbestos very
useful for fire-proofing and insu-
lating homes and all kinds of public
and private buildings. Other asbes-
tos products include reinforced
asbestos cement sheets and pipes,
pipe insulation, roofing felt and
shingles, floor tiles, patching and
taping compounds, brake linings,
clutch facings, insulating paper, and
protective clothing. Some 800,000
tons of asbestos are mined or
processed in the United States each
year to make about 3,000 different
products, two-thirds of which are
used in the construction industry.
Unless it is completely sealed into
a product, as in asbestos floor tile,
asbestos can easily break into a dust
of tiny fibers. These fibers, much
smaller and more buoyant than
ordinary dust particles, float almost
indefinately in the air and can easily
be inhaled or swallowed. Once the
fibers enter the body, they cause a
number of serious diseases:
• Asbestosis, a chronic disease of
the lungs that makes breathing more
and more difficult and can cause
death.
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• Cancer. Breathing asbestos fibers
can cause lung cancer. Also, since
some of the asbestos fibers are
rejected by the lungs, and move up
to the throat and are swallowed,
breathing asbestos also can cause
cancer of the esophagus, stomach,
intestines, and rectum.
• Mesothelioma, a cancer of the
membranes that line the chest and
abdomen. Mesothelioma almost
never occurs in people who have not
been exposed to asbestos. It always
is fatal.
Once asbestos gets into the body,
it remains there indefinitely. It can
move from the lungs to almost all
other parts of the body, including the
brain and the sex organs. Cancer
can occur anywhere from 1 5 to 40
years after the first exposure. No
safe limit or "threshold" of exposure
is known. Any exposure to asbestos
carries some risk to health, and
people exposed to low levels of
asbestos for a very brief period have
later contracted mesothelioma.
Finally, anyone exposed to asbestos
who also smokes cigarettes has five
times the chance of contracting lung
cancer than a cigarette smoker who
has not been exposed to asbestos.
The Occupational Safety and
Health Administration has
established limits for worker
exposure to asbestos on the job. The
Food and Drug Administration is
responsible for making sure that
foods, drugs, and cosmetics are not
contaminated with asbestos. And
the Consumer Product Safety Com-
mission (CPSC) regulates asbestos in
consumer products. EPA prohibited
the spraying of asbestos materials
for fire-proofing and insulation in
1973, banned the use of asbestos
that can crumble in pipe and boiler
coverings in 1975, and prohibited
virtually all uses of sprayed asbestos
materials in 1978. In addition, EPA
is investigating the cumulative
effects on public health of exposure
to asbestos—from the time it is
mined and milled, through
processing and product manu-
facturing, use and disposal. And EPA
also is considering banning all non-
essential uses of asbestos and
asbestos products. To safeguard the
health of school children, teachers,
and others who work in schools,
EPA has launched a nationwide
technical assistance program to help
States and school districts identify
schools where deteriorating asbes-
tos-containing material should be
removed or sealed.
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Kepone
In 1 950, two employees of the Allied
Chemical Company filed a patent for
Kepone, a gray insecticide powder.
By 1965, Allied Chemical was man-
ufacturing and selling small amounts
of Kepone. Then demand increased,
and in 1973, a small company, Life
Sciences Products, contracted to
produce Kepone for Allied Chemical.
Life Sciences began production at a
converted gasoline station in Hope-
well, Virginia in early 1974.
In July 1975, an employee at the
Kepone plant in Hopewell went to
his private physician, complaining of
tremors, weight loss, and ner-
vousness. He could barely hold a
cup of coffee, and his eyes moved
uncontrollably. Other employees at
the Kepone plant had similar
symptoms; they had been told by
company and other doctors that they
had a bad case of "nerves". But this
employee's doctor suspected other-
wise. He sent a sample of the
Kepone plant employee's blood to
the U.S. Government Center for
Disease Control. The results
triggered an investigation that
uncovered a monumental horror
story.
The Kepone plant employee's
blood contained 7.5 parts per million
of Kepone—dangerously high. Other
employees at the plant were also
very sick; about 30 had been in and
out of the hospital. More than 200
men, women, and children in the
area had detectable levels of Kepone
in their blood. Over 50 had "Kepone
sickness"—severe tremors, uncon-
trollable twitching of the eyes, liver
damage, and reproductive effects
including the future possibility of
becoming sterile. There was also the
danger of cancer, because Kepone
had been shown to cause cancer in
test animals.
The Kepone tragedy went far
beyond the plant employees and
their families. Kepone was found in
the James River, which flows past
the Hopewell plant. The contami-
nation was severe enough to compel
the closing of the entire James River
to commercial fishing, depriving
3,800 people of their livelihood.
Kepone also contaminated fish in
the Chesapeake Bay, and was found
in wildlife and birds, especially those
that feed on fish.
The Kepone plant was shut down
by the State. But it had taken an
enormous toll, whether measured in
human tragedy and suffering,
environmental damage, or financial
loss. However, it need not have
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lappened, for the human and
environmental impacts of Kepone
were known and ignored by the
chemical's producers. They did little,
if anything, to protect the plant
employees from Kepone and to keep
he toxic chemicals out of the air,
land, and water.
After the dimensions of the
Kepone story became known, the
U.S. Environmental Protection
Agency estimated that the Hopewell
slant could have been made safe
with an initial investment of about
$200,000. Instead, the damage to
Deople and the environment already
otals many millions of dollars and
may reach the billions.
Tris
After the U.S. Department of
Commerce established mandatory
lameproofmg standards for
children's pajamas and nightgowns
in 1972, a fire retardant chemical,
called Tris, was developed by
industry. It soon was used in about
half of the children's sleepwear sold
in the nation. In 1973-74, the first
year flame-proofing was mandatory,
children's burns and deaths from
clothing fires declined. But then,
EPA-funded researchers at Columbia
University discovered that Tris could
cause mutations or changes in cells.
And the National Cancer Institute
found that Tris was a highly potent
cancer-causing agent in test
animals. Researchers also found
that the chemical could be absorbed
through the skin. In April 1977, the
Consumer Product Safety Com-
mission halted the production and
sale of Tris-treated clothing. In an
effort to protect children from fire,
millions had been exposed to the
risk of cancer.
Polychlorinated Biphenyls (PCBs)
PCBs range in consistency from oily
liquids to waxy solids and were
developed primarily for use as a
coolant in electrical equipment—
transformers, capacitors, electro-
magnets, and heat transfer and
hydraulic systems. They have also
been used as plasticizers in paints,
adhesives, and caulking compounds;
fillers for casting waxes, and dye
carriers in carbonless copy paper.
Only after an estimated 450 million
pounds of PCBs had entered the
environment was it discovered that
they cause skin lesions, swollen
limbs, eye and liver problems, and
may cause cancer and birth defects.
PCBs also tend to become more and
more concentrated as they move up
the food chain, and they are
extremely slow to break down in the
environment. Like PCBs' distant
cousin, DDT, they now are every-
where in the environment con-
taminating fish in rivers and lakes,
cattle, chickens, and food products.
More than half the people in the
United States have some PCBs in
their bodies. The dangerous, per-
sistent chemical is now banned from
being made in this country, and has
been permitted to remain only in
existing, in-service electrical trans-
formers and certain other limited
industrial uses.
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These incidents are but a few of
many. Too often in the past,
chemical products were put on the
market with little or no awareness of
their impact on human health and
the environment. In recent years,
catastrophies associated with DDT,
DBCP, vinyl chloride, thalidomide,
asbestos, lead, mercury, Kepone,
Tris, PCBs and other toxic sub-
stances have captured considerable
national attention and concern.
To help prevent similar problems
in the future, Congress in 1976
enacted the Toxic Substances Con-
trol Act (TSCA), which directs the
U.S. Environmental Protection
Agency (EPA) "to regulate chemical
substances and mixtures which
present an unreasonable risk of
injury to health and the environ-
ment."
EPA already had the authority,
under laws enacted earlier, to
regulate discharges of toxic sub-
stances in waterways and drinking
water, emissions of toxic substances
in the air, the disposal of toxic and
hazardous solid wastes, and the
adverse effects of pesticide
products.1 But under these taws,
EPA's authority was limited to
controlling toxics after damage
occurred, placing the Agency in a
position only to react to toxic
problems rather than to prevent
'The five major Federal laws, enacted prior to TSCA,
under which EPA works to control hazardous chemi-
cals, are (1) the Clean Water Act (CWA), (2) the Safe
Drinking Water Act (SDWA), (3) the Clean Air Act
(CAA), (4) the Resources Conservation Recovery Act
(RCRA), and (5) the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA)
them from occurring. Also, the other
laws did not allow for the screening
of toxic substances before they
entered the market place them-
selves, or as components of
products.
TSCA is one of the most important
public health and environmental
laws ever enacted by Congress. It
closes the gaps in earlier laws, and
requires that the health and environ-
mental effects of all new chemicals
be reviewed before they are manu-
factured and put on the market.
Also, for the first time with TSCA's
authorities, the Federal government
can gather information on chemical
substances needed to determine
their potential for damaging human
health and the environment, and to
control them, where necessary, to
protect the public.
While TSCA cannot prevent
human error, it should make future
chemical catastrophes much less
likely.2 TSCA's enactment marks a
recognition that we live in a
chemical age, and that age may be a
mixed blessing.
This booklet outlines, in nontech-
nical language, the programs
enacted by Congress in TSCA to
protect health and the environment
from toxic substances.
2Eight categories of products are exempt from TSCA,
because they are regulated under other Federal
laws They are tobacco, nuclear materials, firearms
and ammunition, food, food additives, drugs,
cosmetics, and pesticides (which EPA regulates
under FIFRA)
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The Law
The U.S. Environmental Protection
Agency (EPA) administers the Toxic
Substances Control Act (TSCA). The
purpose of TSCA is to identify and
control chemicals that pose an
unreasonable risk to human health
or the environment. Essentially, this
is done in four major ways.
First, needed information on chemicals
is developed and gathered by EPA . . .
Congress recognized during its
discussion on TSCA that very little
was known about chemicals in the
environment. In fact, when the law
was passed it was not even known
how many chemicals there were, in
what quantities they were produced
and where, what their byproducts
were, who was exposed to them and
under what conditions. This informa-
tion was available only for a handful
of existing chemicals. Therefore,
Congress gave EPA the authority to
compile an inventory of existing
chemical substances, and to develop
additional information on these basic
questions.
The first inventory was published
in 1979, based on information
reported to EPA by chemical manu-
facturers, importers, and processors.
The inventory—which will be revised
and kept current—shows that nearly
50,000 commercial chemical sub-
stances are manufactured or
imported into the United States.
(There are well over 4 million known
chemical compounds, but most are
research and development chemicals
that are not used commercially.)3
It is important to note that the
chemical inventory is not a list of
toxic or hazardous chemicals.
Rather, it lists existing chemicals by
their specific chemical name (e.g.,
acetonitrile, bromobenzene, chloro-
methane, etc.), giving for the first
time an overall picture of the
chemicals used for commercial
purposes in the United States. In
addition to being unprecedented,
this list is of major importance
because chemicals not on the
inventory must first be reviewed by
EPA for hazardous health and
environmental effects before they
are allowed into U.S. commerce.
3The authority to gather information and control
chemicals, under TSCA, extends only to those used
for commercial^urposes in the United States,
research and development chemicals are not
covered until their introduction into the U S
marketplace
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Second, industry is required to provide
information (e.g., testing, existing
health and safety data) on how
chemicals affect human health and the
environment . . .
Congress determined in TSCA that
adequate information should be
developed on how chemicals affect
health and the environment, and
that those who manufacture and
process commercial chemicals
should be the ones responsible for
developing this information. EPA can
issue rules requiring industry to test
particular chemicals, and issues
testing standards specifying the
procedures to be used in conducting
tests for certain health and the
environmental effects.
To help the Agency determine
which potentially toxic chemicals
should be tested first. Congress
through TSCA created the Inter-
agency Testing Committee (ITC).4
The ITC identifies and recommends
to EPA chemicals it believes warrant
priority consideration for health and
environmental effects testing.
EPA also has a comprehensive
chemical assessment process during
which the full range of adverse
effects and exposure sources to
human health and the environment
are identified. This multi-staged
"The ITC is composed of representatives of the
Council on Environmental Quality, the Department
of Commerce, the National Science Foundation, the
National Institute of Environmental Health
Sciences, and the National Institute for Occupa-
tional Safety and Health, and of non-voting
observers from the Department of Defense and
Interior, the Food and Drug Administration and
the Consumer Product Safety Commission
process helps select chemicals likely
to present significant and un-
reasonable risks, as well as those
for which more additional informa-
tion, such as through testing, is
needed.
Determining which chemical sub-
stances need to be tested is a
complex job. And the testing itself
can be expensive, depending on
what the testing is. For example, it
takes a team of scientists 2 to 3
years, some 300 laboratory animals,
and $300,000 to determine if a
single suspect chemical may cause
cancer, birth defects—such as cleft
palate or mental retardation—or
increased abnormalities—such as
those suffered by the children of
women who took the drug thalido-
mide.
When the danger signals are
present, the testing must be done to
prevent more Kepone, PCB, and
thalidomide-like tragedies.
TSCA authorizes EPA to require
the submission of existing health
and safety information by industry
and others. This also is a very
important way for EPA to determine
what information already has been
gathered on chemicals, and what
gaps exist that may be filled through
follow-up efforts. Specifically, any-
one who has information that
reasonably concludes that a chemi-
cal presents a substantial risk of
injury to health or the environment
must immediately notify EPA. Also,
the chemical industry (manu-
facturers, processors, and dis-
tributors) is to keep records of "sig-
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nificant adverse reactions" to health
and the environment alleged to have
been caused by a chemical. 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 environmental
effects—must be kept 5 years. EPA
has the authority to request copies
or lists of these records at any time,
as well as to ask for all existing
health and safety data on specific
chemicals as needed.
A chemical may 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 sub-
stantial human exposure or environ-
mental release. In either case, EPA
must show that existing data on the
chemical's effects are insufficient for
determining the risk, and that
esting is necessary to provide this
information
Third, chemicals are controlled that
pose unreasonable risks to health and
the environment . . .
If the risks of a chemical outweigh
its benefits to health and the
environment, EPA can take a variety
of regulatory actions. Regulation
may range from labeling require-
ments and warnings; to limiting the
handling, use, or distribution of a
chemical, to an outright ban on the
manufacture and processing of the
chemical. If EPA proposes to
regulate a chemical substance, it
must publish a notice in the Federal
Register substantiating this decision,
explaining: exposure levels and
effects of the chemical on health or
the environment; the chemical's
benefits and availability of sub-
stitutes; and the economic con-
sequences of regulating the chemi-
cal, including the impact on the
national economy, small business,
and technological innovation.
Under this provision, EPA has
banned the manufacture, proces-
sing, distribution, and use of poly-
chlorinated biphenyls (PCBs), the
only chemical mentioned by name in
TSCA. An oily synthetic liquid, PCBs
cause skin lesions, swollen limbs,
eye and liver problems. It may also
cause cancer and birth defects.
Because of the known dangers of
PCBs, EPA banned their general use
as of July 1 979. PCBs may no
longer be made in the U.S., and may
now only be used in sealed
systems—such as electrical trans-
formers and capacitors found in
television sets, air conditioners, and
microwave ovens. With normal use
in those products, there is no human
or environmental exposure to PCBs.
EPA also has used this provision
of TSCA to prohibit the use of
chlorofluorocarbons (CFCs) as pro-
pellants in aerosol (spray can)
products. That action, taken in
cooperation with the Food and Drug
Administration and the Consumer
Product Safety Commission, was
based on the growing evidence that
CFCs deplete the ozone layer in the
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10
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stratosphere which protects the
earth from damaging ultraviolet
radiation from the sun. Depletion of
the ozone may result in increased
skin cancer in humans and damage
plants and animals.
Fourth, new chemicals are subject to a
premanufacture review program before
being allowed into the U.S. market-
place . . .
TSCA requires the chemical industry
to notify EPA before making or
importing a new chemical5 into the
U.S. for a commercial purpose. This
requirement is the key preventive
measure for protecting people and
the environment from dangerous
new chemical products. As of July
1979, the maker or importer of a
new chemical must submit the
following information to EPA at least
90 days before putting the new
chemical on the market.
• All available studies on the health
and environmental effects of the
chemical.
• Its common or trade name.
• Its chemical identity and
molecular structure.
• Proposed uses, and estimated
amounts to be produced or imported
for each use.
• Methods of disposal.
• Workplace exposure.
• Byproducts.
With this information, and con-
sidering other pertinent factors, EPA
can take one of the following
actions.
1. EPA can decide to take no action
on a chemical substance. If EPA
does not act within 90 days (180
days if the review period is extended
because more information is re-
quested), the manufacturer may
begin production (or the importer
may begin importation) of the new
chemical.
2. EPA may regulate a substance
until additional health and environ-
mental data is made available to
permit an evaluation of the chemi-
cal's effects. The regulation may
5A "new" chemical substance is one not included
on the TSCA inventory, compiled by EPA, which
lists existing substances already in U S commerce
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11
include bans or limits on the
production or use of the substance.
If the manufacturer objects, EPA can
seek an injunction in the Federal
District Courts.
3. EPA can prohibit or regulate the
manufacture, processing, distri-
bution, use, or disposal of the new
chemical, if it finds that the new
chemical poses an unreasonable risk
to health or the environment.
Regulations may range from labeling
requirements to more stringent
controls such as limiting human or
environmental exposure to the
chemical to a ban. If EPA intends to
prohibit the manufacture, proces-
sing, or distribution of the sub-
stance, the Agency may issue a
proposed order. If the manufacturer
objects, EPA may go to court for an
injunction. In other cases, EPA may
propose a rule in the Federal
Register.
4. If immediate regulation is not
necessary, but EPA believes that
future increases in exposure may
cause concerns, the Agency may
propose rules requiring the manu-
facturer and others to report "sig-
nificant new uses" or other changes
in exposures and releases.
5. EPA may also refer the chemical
to other EPA programs or other
Federal regulatory agencies if it is
believed that the chemical shuld be
reviewed or regulated under another
statutory authority.
Anyone who manufactures or
uses a new chemical that has not
gone through the premanufacturing
review process, and anyone who
violates any other requirement of
this law, is subject to penalties or
fines up to $25,000 for each day of
violation, one year in prison, or both.
EPA is authorized to inspect chemi-
cal manufacturing, processing and
storage facilities and to subpoena
witnesses and documents to enforce
TSCA.
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12
Some
Final Words
As directed by Congress in the law,
EPA seeks to regulate toxic chemi-
cals "m such a manner as not to
impede unduly or create unneces-
sary economic barriers to tech-
nological innovation while fulfilling
the primary purposes of this Act to
assure that such innovation and
commerce in such chemical sub-
stances and mixtures do not present
an unreasonable risk of injury to
health or the environment."
To carry out this Congressional
mandate, EPA seeks to balance a
chemical's risks to society against its
benefits to society. EPA considers
the seriousness of the risk, the
availability of alternatives to the
chemical and the risks associated
with them, and the economic and
social benefits that would stem from
the production and use of the
chemical.
To help the Agency reach the right
decisions as TSCA is being
implemented and to help ensure that
a chemical does not pose an
unreasonable risk of injury to health
or the environment, EPA invites the
assistance, support, and cooperation
of the chemical industry, the
scientific community, and all
interested citizens and organizations.
For further information contact your EPA regional toxic substances office.
Region 1
Toxic Substances Program
John F Kennedy Building
Boston, MA 02203
617 - 223-0585
Region 2
Toxic Substances Program
26 Federal Plaza
New York, NY 10007
212 - 264-1925
Region 3
Toxic Substances Program
6th and Walnut Streets
Philadelphia, PA 19106
215 - 597-4058
Region 4
Toxic Substances Program
345 Courtland Street, NE
Atlanta, GA 30308
404 - 881-3864
Region 5
Toxic Substances Program
230 South Dearborn Street
Chicago, IL 60604
312 - 353-2291
Region 6
Toxic Substances Program
1201 Elm Street
First International Building
Dallas, TX 75270
214 - 767-2734
Region 7
Toxic Substances Program
324 East 11th Street
Kansas City, MO 64108
816 - 374-6538
Region 8
Toxic Substances Program
1860 Lincoln Street
Denver, CO 80203
303 - 837-3926
Region 9
Toxic Substances Program
215 Freemont Street
San Francisco, CA 94105
415 - 556-4606
Region 10
Toxic Substances Program
1200 6th Avenue
Seattle, WA 98101
206 -442-1090
For sale hy the Superintendent of Documents, U.S Government Printing Office
Washington. D C. 20402
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