
[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


