Chemical Regulation: Actions are Needed to Improve the Effectiveness of EPA's Chemical Review Program Page: 5 of 18
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to ban or limit the production of only five existing chemicals or groups of
chemicals.
EPA's reviews of new chemicals can provide only limited assurance that
health and environmental risks are identified before the chemicals enter
commerce because TSCA does not require chemical companies to test
new chemicals before notifying EPA of their intent to manufacture a
chemical. Furthermore, chemical companies generally do not voluntarily
perform such testing. Because of a general lack of data, EPA has
developed sophisticated methods to predict the potential exposure and
toxicity levels of new chemicals by using scientific models to compare
them with chemicals with similar molecular structures for which toxicity
information is available. However, the use of these models can present
weaknesses in the assessment because the models are not always accurate
in predicting physical chemical properties and the evaluation of general
health effects is contingent on the availability of information on chemicals
with similar molecular structures. Additionally, chemical company
estimates of a chemical's production volume and anticipated uses
provided in the premanufacture notices that EPA uses to assess exposure,
can change substantially after EPA completes its review and
manufacturing begins. However, these estimates do not have to be
amended by companies unless EPA promulgates a rule determining that a
use of a chemical constitutes a significant new use, which EPA has done
for only a small percentage of new chemicals. Despite limitations in the
information available on new chemicals, EPA's reviews have resulted in
some action being taken to reduce the risks of over 3,600 new chemicals
submitted for review.
EPA's ability to provide the public with information on chemical
production and risk has also been hindered by strict confidential business
information provisions of TSCA. TSCA generally prohibits the disclosure
of confidential business information and, according to EPA officials, about
95 percent of the premanufacture notices for new chemicals contain some
information that is claimed as confidential. While EPA has the authority to
evaluate the appropriateness of confidentiality claims, these efforts are
time and resource-intensive, and the agency does not have the resources
to challenge a significant number of claims. State environmental agencies
and others have expressed interest in obtaining information claimed as
confidential business information for use in various activities, such as
developing contingency plans to alert emergency response personnel to
the presence of highly toxic substances at manufacturing facilities.
Chemical companies recently have expressed interest in working withGAO-06-1032T
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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/m1/5/: accessed April 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.