EPA Publishes Action Plan to Address BPA Concerns
The Environmental Protection Agency (EPA) recently published an action plan to address concerns over bisphenol A (BPA), which has purportedly “caused reproductive and developmental effects in animal studies and may also affect the endocrine system.” Intended to strengthen the agency’s chemical management program, the plan focuses on the plasticizer’s environmental impact and proposes (i) adding BPA to the chemical concern list; (ii) gathering information on BPA concentrations in surface, ground and drinking water; (iii) requiring manufacturers to provide EPA with test data related to long-term effects on growth, reproduction and development in aquatic organisms and wildlife; (iv) using EPA’s Design for the Environment program to reduce unnecessary exposures and find acceptable substitutes; and (v) continuing to evaluate “the potential disproportionate impact on children and other sub-populations through exposure from non-food packaging uses.” In addition, EPA has pledged to work with the Food and Drug Administration (FDA) and other federal entities to cover BPA exposure cases “that fall outside FDA’s reach but within EPA’s regulatory authority.” See EPA Press Release, Law360 and MSNBC.com, March 29, 2010; Scientific American, April 7, 2010.
Meanwhile, FDA has announced the availability of five documents related to its ongoing assessment of BPA. According to FDA, “These documents do not represent an agency opinion or position on BPA,” but “provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA.” The agency has specifically solicited public comments on four documents prepared by its Center for Food Safety and Applied Nutrition (CFSAN), which has reviewed information related to (i) low-dose studies; (ii) BPA exposure from the consumption of infant formula, toddler food and adult (canned) food; and (iii) BPA biomonitoring studies. FDA will accept public comments until June 4, 2010. See Federal Register, April 5, 2010.
In a related development, the European Food Safety Authority (EFSA) convened a March 26, 2010, international summit in Parma, Italy, where the regulator outlined its preliminary draft opinion on BPA and received input from 25 scientific experts. The consultation apparently focused on “the design of scientific studies on BPA, toxicological aspects and the strengths and weaknesses of certain individual studies.” EFSA later discussed new risk assessments and studies with representatives from FDA, Health Canada, Food Standards Australia New Zealand, the Food Safety Commission of Japan and the World Health Organization during a March 29 teleconference. EFSA’s panel on food contact materials reportedly plans to finalize two independent BPA assessments in late May 2010. See EFSA Press Release, March 31, 2010.
