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Lynn L. Bergeson is managing director of Bergeson & Campbell, P.C., a Washington, D.C., law firm focusing on conventional and engineered nanoscale chemical, pesticide, and other specialty chemical product approval and regulation, environmental health and safety law, chemical product litigation, and associated business issues, and President of The Acta Group L.L.C. and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, U.K.

EPA to Publish ANPR Concerning Testing of BPA

August 2, 2011
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The EPA is considering requiring additional testing to gather additional data on BPA.

The EPA is currently scheduled to publish on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). The agency will request comments on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. The EPA also will seek comments on requiring environmental testing consisting of sampling and monitoring for BPA in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA that are at or above levels of concern for adverse effects, including endocrine-related effects. The agency states that the ANPR is directed only toward the environmental presence and environmental effects of BPA. According to the notice, the EPA is working with the Department of Health and Human Services on potential human health issues, but is not considering any additional testing specifically in regard to human health issues at this time. Comments will be due 60 days after the ANPR is published in the Federal Register. The pre-publication version of the ANPR is available online.

The ANPR includes the following questions for commenters:

  • Whether the EPA should propose requiring specific toxicity testing to characterize more fully the effects of BPA on environmental organisms at low concentrations;
  • Whether the EPA should propose requiring environmental testing consisting of sampling and monitoring, particularly in the vicinity of reported releases of BPA into the environment, and what design and protocol it should use for such sampling and monitoring, to identify potential sources and pathways of exposure, and determine the extent to which environmental organisms may be exposed to BPA concentrations of concern as determined by existing data and by additional studies that are either already underway or would be conducted under a test rule; and
  • The EPA additionally requests comment and supporting information regarding which Toxic Substances Control Act (TSCA) Section 4(a)(1) finding authority would be most appropriate for the purpose of a BPA test rule proposal. Any proposal would ultimately be based on the EPA's assessment of the relevant information available at the time of proposal.
The EPA reaffirms that, as stated in the BPA Action Plan, it does not intend to initiate regulatory action under TSCA at this time on the basis of human health. The agency notes that most human exposure, including exposure to children, comes through food packaging materials, which are under the jurisdiction of the Food and Drug Administration (FDA). According to the EPA, the FDA, together with the Centers for Disease Control and Prevention (CDC) and the National Institute of Environmental Health Sciences (NIEHS), "is investing in important new health studies in both animals and humans to better determine and evaluate the potential health consequences of BPA exposures." The EPA will continue to coordinate closely with the FDA, CDC, and NIEHS on this activity. The EPA states that, to the extent that the FDA may identify health concerns from BPA in food contact materials, the EPA will work with the FDA to identify and assess potential substitutes. Levels of exposure that may be identified by the ongoing review as being of concern to human health, including children's health, will affect the extent to which the EPA would take additional action to address potential risks to human health resulting from uses within TSCA jurisdiction.
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