[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