[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Proposed Rules]
[Pages 9608-9610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. FDA-2012-F-0031]


American Chemistry Council; 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 the 
American Chemistry Council (ACC) has filed a petition proposing that 
the food additive regulations be amended to no longer provide for the 
use of polycarbonate (PC) resins in infant feeding bottles and spill-
proof cups designed to help train babies to drink from cups because 
these uses have been abandoned. PC resins are formed by the 
condensation of 4,4'-isopropylenediphenol (i.e., Bisphenol A (BPA)), 
and carbonyl chloride or diphenyl carbonate.

DATES: Submit either electronic or written comments by April 17, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
F-0031 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 9609]]

     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-0031. 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(s), 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 1B4783) has been filed by the American Chemistry 
Council (ACC), 700 Second St. NE., Washington, DC 20002. The petition 
proposes to amend the food additive regulations in 21 CFR 177.1580 to 
no longer permit the use of PC resins in infant feeding bottles (``baby 
bottles'') and spill-proof cups designed to help train babies to drink 
from cups (``sippy cups'') because these uses have been abandoned. 
Polycarbonate resins are formed by the condensation of 4,4'-
isopropylenediphenol (i.e., BPA), and carbonyl chloride or diphenyl 
carbonate.

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.'' (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 21 CFR 171.1 and 171.100 for submitting petitions.'' (21 CFR 
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 regulatory authorization is no longer 
necessary for the use of that food additive.
    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 ACC petition contains public information and information 
collected from companies that produce PC resins to support the claim 
that baby bottles and sippy cups containing PC resins are no longer 
being introduced into the U.S. market and that manufacturers of baby 
bottles and sippy cups have abandoned the use of PC resins in making 
these products. The petition contains the results of an industry poll 
showing that the PC resin manufacturers, which represent over 97 
percent of worldwide, global PC resin production capacity, are no 
longer, to their knowledge, selling PC resins to be used in the 
manufacture of baby bottles and sippy cups intended for import into the 
United States or sale in the U.S. market.
    FDA expressly requests comments on ACC's proposal that FDA amend 
the food additive regulations to no longer permit the use of PC resins 
in baby bottles and sippy cups. For the purposes of this petition, FDA 
considers ``sippy cups'' to mean spill-resistant training cups, 
including their closures and lids, intended for use by babies or 
toddlers. As noted, the basis for the proposed amendment is that the 
use of PC resins in the manufacture of baby bottles and sippy cups has 
been abandoned. Accordingly, FDA requests comments that address whether 
these uses of PC resins have been abandoned, such as information on 
whether baby bottles or sippy cups containing PC resins are 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 ACC's petition (baby bottles and sippy cups) have been adequately 
defined. FDA is not currently aware of information that would suggest 
continued use of PC resins in the manufacture of baby bottles and sippy 
cups. FDA is providing the public 60 days to submit comments.
    The Agency is not requesting comments on the safety of these uses 
of PC resins because, as discussed previously in this document, such 
information is not relevant to abandonment, which is the basis of the 
proposed action. Any comments addressing the safety of PC 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). Interested persons with safety information that 
has not previously been submitted to FDA on the use of PC resins may 
provide that information to Docket No. FDA-2010-N-0100. Although this 
docket is no longer accepting electronic comments, written comments 
will be accepted by FDA's Division of Dockets Management (see 
ADDRESSES).
    The Agency 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,

[[Page 9610]]

neither an environmental assessment nor an environmental impact 
statement is required.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

    Dated: February 13, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2012-3744 Filed 2-16-12; 8:45 am]
BILLING CODE 4160-01-P