[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Pages 17145-17147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7511]



Food and Drug Administration

[Docket No. FDA-2010-N-0100]

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, 

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.


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

[[Page 17146]]

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.

    \1\ See table 1 of this document for a description of Document 
(Doc.) numbers 1 through 5.

    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.

                                Table 1.
   No.       Date                            Title
1         August 31,  Memorandum from Toxicology Group 1, Division of
           2009        Food Contact Notifications, Office of Food
                       Additive Safety, Center for Food Safety and
                       Applied Nutrition; HFS-275: ``Bisphenol A (CAS
                       RN. 80-05-7): Review of Low-Dose Studies''
2         November    External Governmental Reviewer Comments on Draft
           2009        Report: ``Bisphenol A (CAS RN. 80-05-7): Review
                       of Low-Dose Studies''
3         November    Memorandum from Toxicology Group 1, Division of
           24, 2009    Food Contact Notifications, Office of Food
                       Additive Safety, Center for Food Safety and
                       Applied Nutrition; HFS-275: ``Bisphenol A (CAS
                       RN. 80-05-7): studies added to `Review of Low
                       Dose Studies' assessment''
4         October     Memorandum from: Chemistry Review Group 1,
           22, 2009    Division of Food Contact Notifications and
                       Chemistry Team, HFS-275 and Chemistry Review
                       Team, Division of Biotechnology and GRAS Notice
                       Review, Office of Food Additive Safety, Center
                       for Food Safety and Applied Nutrition; HFS-255:
                       ``Exposure to Bisphenol A (BPA) for infants,
                       toddlers and adults from the consumption of
                       infant formula, toddler food and adult (canned)
5         November    Memorandum from: Regulatory Group 2, Division of
           16, 2009    Food Contact Notifications, Office of Food
                       Additive Safety, Center for Food Safety and
                       Applied Nutrition, HFS-275: ``Summary of
                       Bisphenol A Biomonitoring Studies''

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

[[Page 17147]]

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 

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 
    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.

    Dated: March 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7511 Filed 4-2-10; 8:45 am]