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#564 - The Toxic Substances Control Act, 17-Sep-1997

Twenty-one years ago, Congress passed the Toxic Substances Control Act
(TSCA, pronounced toska). As the name of the law implies, the purpose
of TSCA is to control toxic substances. But of course, before you can
control toxic substances, you must know which chemicals are toxic. This
requires testing. According to U.S. Environmental Protection Agency
(EPA), as of October, 1996, there were 75,857 chemical substances in
commercial use.[1,pg.20] The question is, how many have been tested for

In principle, all of them should have been tested by now. TSCA says,
"It is the policy of the United States that... adequate data should be
developed with respect to the effect of chemical substances and
mixtures on health and the environment and that the development of such
data should be the responsibility of those who manufacture and those
who process such chemical substances and mixtures." [15 U.S.C.
paragraph 2601(b)] [1,pgs.23-24]

Now a new report from the Environmental Defense Fund (EDF) scores the
chemical industry's and EPA's progress toward the goals of TSCA.[1] EDF
concludes that "the policy is largely defunct."[1,pg.24] EDF says, "[F]
or most of the important chemicals in American commerce, the simplest
safety facts still cannot be found. This report documents that, today,
even the most basic toxicity testing results cannot be found in the
public record for nearly 75% of the top-volume chemicals in commercial

EDF revisited a question that was first asked in 1984 by the National
Research Council (NRC) of the National Academy of Sciences. In 1984 the
NRC studied a random sample of 100 chemicals chosen to fairly represent
the roughly 3000 chemicals produced each year in quantities exceeding
one million pounds. The NRC concluded in 1984 that 78% of these
chemicals lacked even "minimal toxicity information."[2] Now in 1997,
EDF has asked the same question, to see if the chemical industry and
EPA have made progress since 1984. EDF reports that, today, 71% of the
chemicals examined lack minimal toxicity information.

EDF drew its random sample of 100 chemicals from a list of 486
chemicals that are BOTH high production (greater than one million
pounds per year, of which there are 2971 chemicals) and that ALSO have
been identified as subjects of regulatory attention under major
environmental laws.[3] (EDF excluded food additives, tobacco products,
drugs, and pesticides because TSCA excludes these chemicals.) These
criteria would bias EDF's sample to include chemicals that have at
least been minimally tested since a completely untested chemical is
unlikely to have been the focus of regulatory attention. Thus the EDF
study very likely overstates the availability of toxicity information
about high-volume chemicals.

What constitutes minimal toxicity screening information? EDF used a set
of criteria developed by the Organisation for Economic Cooperation and
Development (OECD), an international organization made up of the
world's 19 wealthiest countries, including the U.S. In 1990, with
extensive participation by industry, the OECD defined criteria for
minimal toxicity screening information for a chemical. (U.S. EPA, on
the other hand, has never defined minimal toxicity screening
information.) OECD defined minimal toxicity information to include:

** Acute toxicity

** Repeated dose toxicity

** Genetic toxicity (tested in a test tube)

** Genetic toxicity (tested in laboratory animals)

** Reproductive toxicity

** Developmental toxicity/teratogenicity

The OECD also included two additional categories of information in its
list of minimum requirements: environmental fate and pathways through
the environment; and ecotoxicology.[4] EDF ignored these environmental
criteria and limited its study to human health effects. Thus the EDF
study, again, very likely overstates the availability of minimum
toxicity information.

It is important to note, as EDF says, that the minimal OECD screening
information for human health does not include sufficient information to
conduct a comprehensive health risk assessment. The data that EDF used
to judge the availability of information is minimal PRELIMINARY
SCREENING information aimed at answering the question: is this chemical
likely to pose a hazard to human health? Here is the EDF scorecard:

** Carcinogenicity tests are missing for 63% of high-volume chemicals.

** Reproductive toxicity is missing for 53% of high-volume chemicals.

** Neurotoxicity tests are missing for 67% of high-volume chemicals.

** Immune system toxicity tests are not available for 86% of high-
volume chemicals.

** Studies for evaluating impacts on children (such as postnatal
performance and neurotoxicity) have not been done for more than 90% of
high-priority chemicals.

** More than half (58%) of the sampled high-priority chemicals have not
been tested for any form of chronic toxicity.

No doubt, smaller-production-quantity chemicals are even less fully
tested that the chemicals EDF studied.

Obviously, TSCA has failed. Who is at fault here? The basic problem
lies in TSCA itself --another well-intentioned but unsuccessful attempt
to 'regulate' corporate behavior. Congress passed TSCA with input from
industry and from the environmental community (EDF included), then EPA
set TSCA regulations after taking input from the same parties. EDF now
acknowledges that TSCA "work[s] poorly in practice" and was "doomed
from the start."[1,pg.25]

TSCA has three main sections aimed at gathering toxicity information
and protecting public health and the environment:

** Section 4 empowers U.S. Environmental Protection Agency (EPA) to
require companies to test chemicals that are currently in use;

** Section 5 requires companies to submit pre-manufacturing
notifications (PMNs) to EPA 90 days before a new chemical enters
commercial markets;

** Section 6 gives EPA the authority to control any chemical that
presents an "unreasonable risk of injury to health or the
environment." [15 U.S.C. Section 2605(a)] Control can include anything
from a labeling requirement to an outright ban.

Let's look at how each section of the law actually works:

TSCA Section 4 says EPA can issue "test rules" (requirements for
toxicity testing) but it puts the agency in a catch-22 position: the
agency must have data in order to require data. Before EPA can issue a
"test rule (i.e., ask for testing) on a specific chemical, the agency
must first show either (1) that the chemical may present an
'unreasonable risk' or (2) both that it is produced in major quantities
AND that either 'substantial' exposures are occurring in quantitative
terms (either numbers of people being exposed, or pounds of material
being released) or that 'significant' exposures are occurring in
qualitative terms (a case-by-case evaluation of the impact of
exposures). Obviously, 'substantial' exposures cannot be proven if
quantitative information on releases of the chemical or exposures to
the chemical is lacking. And 'significant' exposures cannot be proven
without information on the chemical's toxicity. In addition, before
issuing a 'test rule,' EPA must also show that existing data are
insufficient and that testing is 'necessary.' In court, chemical
corporations trip up EPA on all these points.[1,pgs.26,30-31,note 26]
EPA has developed "testing actions" for only 263 chemicals over the
last 20 years, a period during which at least 20,000 new chemicals have
come into use.

TSCA section 5 requires that EPA receive "premanufacture
notification" (PMN) 90 days before a new chemical goes onto the market.
EPA then has 45 days in which to challenge the manufacturer to provide
more test data. However, the law does not require that any toxicity
data accompany the original PMN --data are optional --so EPA usually
has no scientific basis on which to demand additional data. More than
half of all PMNs are submitted without any toxicity data.

The contents of a PMN are not binding and thus there is no incentive
for a manufacturer to insure that its original submission is accurate
or reliable. Once EPA has finished its review of a PMN, the
manufacturer need not limit uses or production levels to those
described in the PMN. Manufacturers are even allowed to revise PMNs
while EPA is reviewing them. When learning that EPA was considering
controls on a chemical, manufacturers have gone back and revised the
exposure estimates for a chemical, to avoid EPA action. They also have
revised PMNs to show lower releases than previously estimated and they
have added claims that the chemicals will be used in zero-discharge

TSCA section 6 gives EPA sweeping powers to control chemicals. Under
TSCA section 6, EPA has the authority to control any chemical that
poses an "unreasonable risk of injury to health or the environment."
But of course proving an "unreasonable risk" in a court of law is a
challenge that the government is usually not up to. Compared to EPA,
even a mid-sized corporation has many more lawyers and much more money
to spend defending its 'right' to expose the public to toxins. In 20
years, EPA has taken Section 6 actions against only 5 chemicals or
classes of chemicals. These include dioxin waste disposal; hexavalent
chromium use in cooling towers; ending the manufacture of PCBs (a
regulation required in the text of TSCA itself); metal fluids; and lead
paint disclosures.

In sum: sections 4, 5, and 6 --the meat and bones of TSCA --simply do
not work. The law is a failure.

Within chemical corporations, the absence of toxicity data is taken to
be proof of safety. For example, the Chemical Manufacturers Association
said in 1996, "Generally speaking, the philosophy of risk-based...
management of chemicals... allows for the continued safe use of
chemicals.... Through [this] approach, we can ensure that chemicals are
used safely." But there are no data to back up such a junk science

Meanwhile, between 1987 and 1992, production of basic chemicals in the
U.S. increased 18%, a growth rate of 3.3% each year.

Having shown conclusively that regulation of the chemical industry
hasn't worked, what is EDF's solution to this large and growing
problem? More regulation. EDF favors expanding the "right to know"
provisions of federal law to give citizens more information about the
poisons that industry is dumping into communities day after day.

This little report from EDF is first-class work. Unfortunately, the
authors of the report seem unable to imagine anything beyond the failed
strategies of the last 20 years. They seem to be saying, "What we've
specialized in for 20 years hasn't worked. It was doomed from the
start. So now we must redouble our efforts to try to get Congress and
EPA to give us more of the same." Very mysterious thinking.

--Peter Montague (National Writers Union, UAW Local 1981/AFL-CIO)


(New York: Environmental Defense Fund, 1997). Available from EDF, 257
Park Avenue South, New York, N.Y. 10010; telephone (212) 505-2100.

[2] National Research Council, TOXICITY TESTING (Washington, D.C.:
National Academy Press, 1984).

[3] The 'major laws' include these federal statutes: the Clean Air Act;
the Clean Water Act; the Comprehensive Emergency Response, Compensation
and Liability Act (Superfund); the Emergency Planning and Community
Right to Know Act (TRI); the Federal Insecticide, Fungicide and
Rodenticide Act; the Occupational Safety and Health Act; and the Safe
Drinking Water Act, and these California statutes: the Air Toxics 'Hot
Spots' Information and Assessment Act; the California Occupational
Safety and Health Act; the California Safe Drinking Water Act; the Safe
Drinking Water and Toxic Enforcement Act (Proposition 65).

[4] For environmental fate and pathways, the OECD lists the following
basic information needs: photodegradation (by estimation); stability in
water (by estimation); monitoring data (environmental); transport and
distribution between environmental compartments; and aerobic
biodegradability. For ecotoxicology the OECD lists the following data
needs: acute toxicity to fish; acute toxicity to daphnids (chronic
toxicity if there is concern for possible long-term effects); toxicity
to algae; appropriate terrestrial toxicity tests (if significant
exposure is expected in the terrestrial environmental compartment or
aquatic testing is not possible. [1,pg.34]

Descriptor terms: edf; studies; tsca; toxic substances control act;
regulation; epa; environmental defense fund; toxic ignorance; toxicity