[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Proposed Rules]
[Pages 41953-41954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17367]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 175
[Docket No. FDA-2012-F-0728]
Representative Edward J. Markey; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petition.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Representative Edward J. Markey has filed a petition proposing that the
food additive regulations be amended to no longer provide for the use
of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for
infant formula because these uses have been abandoned. FDA expressly
requests comments on the petitioner's request.
DATES: Submit either electronic or written comments by September 17,
2012.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
F-0728 by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-F-0728. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Vanee Komolprasert, Center for Food
Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1217.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(b)(5)), notice is given that a food
additive petition (FAP 2B4791) has been filed by Representative Edward
J. Markey, House of Representatives, 2108 Rayburn House Office
Building, Washington, DC 20515-2107. The petition proposes to amend the
food additive regulations in Sec. 175.300 (21 CFR 175.300) to no
longer provide for the use of BPA-based epoxy resins as coatings in
packaging for infant formula because these uses have been intentionally
and permanently abandoned. BPA-based epoxy resins are formed by the
reaction of 4,4'-isopropylenediphenol (i.e., BPA), and epichlorohydrin.
II. Abandonment
Under section 409(i) of the FD&C Act, FDA ``shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations.'' FDA's regulations specific to
administrative actions for food additives provide as follows: ``The
Commissioner, on his own initiative or on the petition of any
interested person, pursuant to part 10 of this chapter, may propose the
issuance of a regulation amending or repealing a regulation pertaining
to a food additive or granting or repealing an exception for such
additive.'' (Sec. 171.130(a) (21 CFR 171.130(a))). These regulations
further provide: ``Any such petition shall include an assertion of
facts, supported by data, showing that new information exists with
respect to the food additive or that new uses have been developed or
old uses abandoned, that new data are available as to toxicity of the
chemical, or that experience with the existing regulation or exemption
may justify its amendment or appeal. New data shall be furnished in the
form specified in Sec. Sec. 171.1 and 171.100 for submitting
petitions.'' (Sec. 171.130(b)). Under these regulations, a petitioner
may propose that FDA amend a food additive regulation if the petitioner
can demonstrate that there are ``old uses abandoned'' for the relevant
food additive. Such abandonment must be complete for any intended uses
in the U.S. market. While section 409 of the FD&C Act and Sec. 171.130
also provide for amending or revoking a food additive regulation based
on safety, an amendment or revocation based on abandonment is not based
on safety, but is based on the fact that the regulatory authorization
is no longer necessary because the use of the food additive has been
abandoned.
Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a petition seeks an amendment to a
food additive regulation based on the abandonment of certain uses of
the food additive, such uses must be adequately defined so that both
the scope of the abandonment and any amendment to the food additive
regulation are clear.
The petition submitted by Representative Markey contains public
information and information collected from a survey of the U.S.
registered manufacturers of infant formula to support the petitioner's
claim that all U.S. infant formula manufacturers have abandoned the use
of BPA-based epoxy resins as coatings in all food contact packaging for
infant formula. According to the petition, these companies accounted
for 100% of the current infant formula market in the United States.
FDA expressly requests comments on the petitioner's request that
FDA amend the food additive regulations to no longer permit the use of
BPA-based epoxy resins as coatings in packaging for infant formula. For
the purposes of this petition, FDA considers the use of BPA-based epoxy
resins as coatings (as described in Sec. 175.300(a)) in packaging of
infant formula to mean a metal substrate (single use) or any suitable
substrate (repeated use) being coated with BPA-based epoxy resins as a
continuous film or enamel, serving as a functional barrier between the
infant formula (powder or liquid) and the substrate. As noted, the
basis for the proposed amendment is that the use of
[[Page 41954]]
BPA-based epoxy resins as coatings in packaging for infant formula has
been permanently and completely abandoned. Accordingly, FDA requests
comments that address whether these uses of BPA-based epoxy resins have
been completely abandoned, such as information on whether infant
formula packaging containing BPA-based epoxy resins as coatings is
currently being introduced or delivered for introduction into the U.S.
market. Further, FDA requests comments on whether the uses that are the
subject of the petition (BPA-based epoxy resins as coatings in infant
formula packaging) have been adequately defined. FDA is not aware of
information that suggests continued use of BPA-based epoxy resins as
coatings in packaging for powder or liquid infant formula. FDA is
providing the public 60 days to submit comments. FDA anticipates that
some interested persons may wish to provide FDA with certain
information that they consider to be trade secret or confidential
commercial information (CCI) that would be exempt under Exemption 4 of
the Freedom of Information Act (5 U.S.C. 552). Interested persons may
claim information that is submitted to FDA as CCI or trade secret by
clearly marking both the document and the specific information as
``confidential.'' Information so marked will not be disclosed except in
accordance with the Freedom of Information Act (5 U.S.C. 552) and FDA's
disclosure regulations (21 CFR part 20). For electronic submissions to
http://www.regulations.gov, indicate in the ``comments'' box of the
appropriate docket that your submission contains confidential
information. Interested persons must also submit a copy of the comment
that does not contain the information claimed as confidential for
inclusion in the public version of the official record. Information not
marked confidential will be included in the public version of the
official record without prior notice.
FDA is not requesting comments on the safety of these uses of BPA-
based epoxy resins as coatings because, as discussed previously, such
information is not relevant to establishing abandonment as the basis of
the proposed action. Any comments addressing the safety of BPA-based
epoxy resins or containing safety information on these resins will not
be considered in FDA's evaluation of this petition. Separate from FDA's
consideration of this petition, FDA is actively assessing the safety of
BPA (see 75 FR 17145, April 5, 2010; see also http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm).
FDA has determined under 21 CFR 25.32(m) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17367 Filed 7-16-12; 8:45 am]
BILLING CODE 4160-01-P