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July 25, 2011

EPA to Publish ANPR Concerning Testing of BPA

Bergeson & Campbell, P.C.

The U.S. Environmental Protection Agency (EPA) is currently scheduled to publish on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). EPA 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. EPA will also 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. EPA states that the ANPR is directed only toward the environmental presence and environmental effects of BPA. According to the notice, EPA is working with the Department of Health and Human Services (HHS) 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:

  1. Whether EPA should propose requiring specific toxicity testing to characterize more fully the effects of BPA on environmental organisms at low concentrations;
  2. Whether 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
  3. 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 EPA’s assessment of the relevant information available at the time of proposal.

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. EPA 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 EPA, 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.” EPA will continue to coordinate closely with FDA, CDC, and NIEHS on this activity. EPA states that, to the extent that FDA may identify health concerns from BPA in food contact materials, EPA will work with 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 EPA would take additional action to address potential risks to human health resulting from uses within TSCA jurisdiction.