Chemical Regulation: Actions are Needed to Improve the Effectiveness of EPA's Chemical Review Program Page: 2 of 18
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Highlights of GAO-06-1032T, testimony
before the Committee on Environment and
Public Works, U.S. Senate
Why GAO Did This Study
Chemicals play an important role in
everyday life, but some may be
harmful to human health and the
environment. Chemicals are used
to produce items widely used
throughout society, such as
cleansers and plastics as well as
industrial solvents and additives.
However, some chemicals, such as
lead and mercury, are highly toxic
at certain doses and need to be
regulated because of health and
safety concerns. In 1976, the
Congress passed the Toxic
Substances Control Act (TSCA) to
authorize the Environmental
Protection Agency (EPA) to control
chemicals that pose an
unreasonable risk to human health
or the environment.
This testimony is based on GAO's
June 2005 report, Chemical
Regulation: Options Exist to
Improve EPA's Ability to Assess
Health Risks and Manage Its
Chemical Review Program (GAO-
05-458). GAO's report describes
EPA's efforts to (1) assess
chemicals used in commerce, (2)
control the use of chemicals not yet
in commerce, and (3) publicly
disclose information provided by
chemical companies under TSCA.
GAO recommended that the
Congress consider providing EPA
additional authorities under TSCA
to improve EPA's ability to assess
chemical risks, and that the EPA
Administrator take several actions
to improve EPA's management of
its chemical review program. EPA
did not disagree with our findings
and is currently implementing
some of our recommendations.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact John B.
Stephenson at (202) 512-3841 or
Actions Are Needed to Improve the
Effectiveness of EPA's Chemical Review
What GAO Found
EPA's authority under TSCA to obtain the data needed to assess existing
chemicals does not facilitate its review process because the costly and time-
consuming burden of obtaining the data is on EPA, rather than chemical
companies. Consequently, EPA has used its authorities to require testing of
fewer than 200 of the 62,000 chemicals in commerce when EPA began
reviewing chemicals under TSCA in 1979. To obtain more data on existing
chemicals, EPA implemented its High Production Volume Challenge
Program, under which chemical companies voluntarily provide test data on
about 2,800 chemicals produced or imported in amounts of 1 million pounds
or more a year. While the purpose of the program is laudable, several
problems remain, including that the chemical industry has not agreed to
provide test data for over 200 chemicals with high production volumes.
Moreover, after obtaining test data, EPA is required under TSCA's provisions
to determine that a chemical poses an unreasonable risk before EPA can act
to regulate its production or use. EPA officials say the act's legal standards
for demonstrating unreasonable risk are so high that they have generally
discouraged EPA from using its authorities to ban or restrict the
manufacture or use of existing chemicals. Since Congress enacted TSCA in
1976, EPA has issued regulations to ban or limit the production of only five
existing chemicals or groups of chemicals.
EPA's reviews of new chemicals provide only limited assurance that health
and environmental risks are identified because TSCA does not require
companies to test chemicals before they notify EPA of their intent to
manufacture the chemicals. Because of a general lack of data on new
chemicals, EPA has developed methods to predict their potential exposure
and toxicity levels by using scientific models to compare the new chemicals
with chemicals that have similar molecular structures and for which toxicity
information is available. However, the use of these models can be
problematic because the models are not always accurate in predicting
chemical properties and EPA's evaluation of general health effects of the
chemicals is contingent upon the availability of information on chemicals
with similar molecular structures. Additionally, the estimates of a
chemical's production volume and anticipated uses, which EPA uses to
assess exposure, can change substantially after EPA completes its review.
Despite these limitations, EPA's reviews have resulted in some action being
taken to reduce the risks of over 3,600 new chemicals.
EPA's ability to provide the public with information on chemical production
and risk is generally limited by the confidential business information
provisions of TSCA. As a result, state agencies and foreign governments
interested in obtaining this data for important purposes are denied access to
the information. Recently, chemical companies have expressed interest in
working with EPA to identify ways of enabling the agency to share
confidential information with other organizations, provided that appropriate
safeguards are adopted to prevent the unauthorized use of the information.
,United States Government Accountability Office
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United States. Government Accountability Office. Chemical Regulation: Actions are Needed to Improve the Effectiveness of EPA's Chemical Review Program, text, August 2, 2006; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc294167/m1/2/: accessed April 18, 2019), University of North Texas Libraries, Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.