Food Additives; Bisphenol A; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comment.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of five documents related to FDA's continuing assessment of Bisphenol A (BPA) and soliciting public comments on the four documents prepared by FDA's Center for Food Safety and Applied Nutrition (CFSAN). These documents do not represent an agency opinion or position on BPA, on which an interim update was recently provided. (See http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm ). Rather, these documents provide perspectives and opinions that are being considered by FDA as it continues its safety assessment of BPA. This action will enable FDA to consider comments from the public in its assessment of BPA for food contact applications.

DATES:

Submit written or electronic information and comments by June 4, 2010.

ADDRESSES:

Submit electronic comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Francis Lin, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1215.

SUPPLEMENTARY INFORMATION:

I. Background

BPA is a chemical used in certain food contact materials. Uses of BPA were approved by FDA under its food additive regulations in the early 1960s. In recent years, questions have been raised about BPA's safety. On August 14, 2008, FDA delivered its Draft Assessment of BPA for Use in Food Contact Applications (the Draft Assessment) (Ref. 1) to a Subcommittee of FDA's Science Board for external review.

On September 16, 2008, the Subcommittee held a public meeting on BPA as part of its external review process, after which the Subcommittee wrote and transmitted its report to the FDA Science Board. On October 31, 2008, the Science Board accepted the Subcommittee's report and transmitted it to FDA with suggestions for revising the Draft Assessment and instructions to conduct a more in-depth review of certain relatively recent low-dose studies identified in a draft report, released in April 2008, by the National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) (Ref. 2) and included in the final assessment completed by the NTP (Ref. 3).

FDA's Center for Food Safety and Applied Nutrition (CFSAN) has provided a review, as suggested by the Science Board, of the low-dose studies mentioned in the NTP report and issued a memorandum describing that review (Doc. 1).¹ In this review (Doc. 1), CFSAN also describes its review of other relevant studies that were either made available since the publication of the NTP report or suggested by the Science Board for consideration. Five expert, non-FDA, government scientists were requested by FDA to conduct a scientific review of CFSAN's assessment of the low-dose studies. Their reviews are combined and made available in Doc. 2 and, as such, provide perspectives on Doc. 1 that may be helpful as additional context, including for those who may want to comment on the CFSAN documents.

Based on its initial review of these materials, FDA recently provided an interim update where it expressed “some concern” about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants, and children, consistent with the final NTP report (Ref. 3), and indicated steps it is taking and interim recommendations, to address these concerns (see http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm ). FDA also recognized (id.), as did the NTP review, substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure. These uncertainties relate to issues such as the routes of exposure employed, the lack of consistency among some of the measured endpoints or results between studies, the relevance of some animal models to human health, differences in the metabolism (and detoxification) of and responses to BPA both at different ages and in different species, and limited or absent dose response information for some studies.

In a third document (Doc. 3), CFSAN reviews and summarizes a number of studies of BPA and health that were made available after its assessment of low-dose studies (Doc. 1). Among the additional studies summarized in Doc. 3 is an as yet unpublished study focused on the potential developmental neurotoxicity of dietary BPA in rats (Ref. 4), which was commissioned by the American Chemistry Council and submitted to FDA.

FDA also is making available CFSAN's updated dietary exposure estimate for the food contact uses of BPA in packaging for infant formula, baby and adult foods, and polycarbonate nursing bottles (Doc. 4). Finally, FDA is making available CFSAN's review of available biomonitoring data on BPA (Doc. 5).

At this time, as FDA continues its safety assessment of BPA, we are seeking public comment on the four CFSAN documents (Docs. 1, 3, 4, and 5) that are relevant to this safety assessment. While pre-decisional documents such as these are not required to be made available for public comment, we believe it is appropriate in this case due to the complexity of the scientific issues and the degree of public interest in FDA's scientific assessment of BPA. As we update our assessment, which may include additional peer review, we will consider any public comments received, as well as new scientific findings as they become available. The five documents, which are available in the docket established for this notice, are listed in table 1 of this document.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the documents at http://www.regulations.gov .

IV. References

We have placed the following references on display in the Division of Dockets Management (see ADDRESSES). You may see them between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to non-FDA Web sites after this document publishes in the Federal Register.

1. Draft Assessment of Bisphenol A for Use in Food Contact Applications (August 14, 2008). Accessible at: http://www.fda.gov/food/foodingredientspackaging/ucm166145.htm .

2. Draft NTP Brief on Bisphenol A, April 14, 2008. Accessible at: http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPADraftBriefVF_04_14_08.pdf .

3. National Toxicology Program, Center for the Evaluation of Risks to Human Reproduction. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08-5994. September 2008. Accessible at: http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf .

4. WIL Research Laboratories, LLC. A Dietary Developmental Neurotoxicity Study of Bisphenol A in Rats (WIL-186056), September 30, 2009.