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FDA to Increase Oversight of BPA, Cites "Some Concern" Over Possible Health Effects

Jan 21, 2010

The U.S. Food and Drug Administration (FDA) announced last week that "on the basis of results from recent studies using novel approaches to test for subtle effects" it now has "some concern" about the potential effects of bisphenol A (BPA) in fetuses, infants, and young children, and, is "carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA." As an interim measure, it is, among other things, also "supporting a shift to a more robust regulatory framework for oversight of BPA." The Agency made the announcement in an update on BPA in food contact applications that it posted on its website January 15, 2010.

Previously, FDA concluded that "an adequate margin of safety exists for BPA at current levels of exposure from food contact uses," in an August 14, 2008 draft report. However, the National Toxicology Program's (NTP) Center for the Evaluation of Risks to Human Reproduction released a report on BPA in September 2008, in which it found that there is "some concern for neural and behavioral effects in fetuses, infants, and children at current human exposures." NTP included some BPA studies in its review that FDA did not consider, and FDA's Science Board Subcommittee on Bisphenol A suggested that the Agency provide a clearer explanation of the criteria used to determine which studies were included in its BPA assessment (see the PackagingLaw.com article, Additional BPA Studies Planned, FDA Tells Science Board, for more information). Subsequently, FDA announced that it would conduct a Post-Market Evaluation of BPA. The Agency said that it would announce the results of the BPA reassessment on November 30, 2009, but did not meet that deadline.

In the January 2010 BPA update, FDA stated that at this interim stage, it "shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children." However, the Agency also stated that there are substantial uncertainties with respect to the interpretation of BPA studies, including questions concerning routes of exposure, the lack of consistency of results between studies, and the relevance of some animal models to human health. FDA's National Center for Toxicological Research, in cooperation with NTP, is currently conducting additional BPA studies to clarify some of these uncertainties.

FDA to Seek Public Input on BPA

FDA said that the next step in it assessment of BPA is to solicit public input. The Agency will open a public docket that contains a review of low dose BPA toxicity studies prepared by its Center for Food Safety and Applied Nutrition (CFSAN), evaluations of the review by five expert scientists from across the federal government, and other relevant material. The docket will be open for public comment for 60 days. FDA will then update its assessment of BPA based on the public comments it receives, and the results of new studies on the safety of BPA.

In the interim, FDA said it will encourage manufacturers to voluntarily submit a food contact notification (FCN) for their currently marketed uses of BPA-containing materials. BPA was cleared for food contact use under food additive regulations issued more than 40 years ago. This is the first time that the Agency has suggested that manufacturers submit a FCN for a cleared substance. FDA explained that if it decides to revoke one or more approved uses for BPA, it would need to undertake what could be a lengthy process of rulemaking. Yet, the Agency said that it "believes that the more modern framework is more robust and appropriate for oversight of BPA than the current one." FDA also announced that it will explore additional options to regulate BPA under "the more modern framework," but did not provide any details.

Other interim measures announced by FDA, are efforts to reduce human exposure to BPA. These include encouraging the development of BPA-free linings for infant formula cans by working with manufacturers on the regulatory status and safety of alternative liners, providing technical assistance on preparation of applications, and expediting the review of applications. The Agency will also support efforts by manufacturers to develop BPA-free can lining for other applications, but cautioned that reliable can lining materials are a critical factor in ensuring the quality of heat processed foods.

FDA concluded the BPA update by noting that it will continue to participate in discussions with international regulatory and public health organizations that have also been engaged in assessing the safety of BPA.