[Federal Register Volume 75, Number 64 (Monday, April 5, 2010)]
[Notices]
[Pages 17145-17147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7511]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
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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.
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\1\ See table 1 of this document for a description of Document
(Doc.) numbers 1 through 5.
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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.
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Document
No. Date Title
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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''
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2 November External Governmental Reviewer Comments on Draft
2009 Report: ``Bisphenol A (CAS RN. 80-05-7): Review
of Low-Dose Studies''
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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''
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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)
food''
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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''
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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
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.
Dated: March 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7511 Filed 4-2-10; 8:45 am]
BILLING CODE 4160-01-S