[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Rules and Regulations]
[Pages 41899-41902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. FDA-2012-F-0031]
Indirect Food Additives: Polymers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
amending the food additive regulations to no longer provide for the use
of polycarbonate (PC) resins in infant feeding bottles (baby bottles)
and spill-proof cups, including their closures and lids, designed to
help train babies and toddlers to drink from cups (sippy cups) because
these uses have been abandoned. The action is in response to a petition
filed by the American Chemistry Council.
DATES: This rule is effective July 17, 2012. Submit either electronic
or written objections and requests for a hearing by August 16, 2012.
See section VIII of this document for information on the filing of
objections.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2012-F-0031, by
any of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections 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 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting comments, see the section VIII. Objections in the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
[[Page 41900]]
objections 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
In a notice published in the Federal Register of February 17, 2012
(77 FR 9608), FDA announced that a food additive petition (FAP 1B4783)
had been filed by the American Chemistry Council (ACC), 700 Second St.
NE., Washington, DC 20002. The petition proposed to amend the food
additive regulations in Sec. 177.1580 (21 CFR 177.1580) to no longer
provide for the use of PC resins in baby bottles and sippy 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. PC resins may be safely
used as articles or components of articles intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, in accordance with the
prescribed conditions of Sec. 177.1580.
II. Evaluation of Abandonment
Under section 409(i) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(i)), 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 regulatory authorization is no
longer necessary for the use of the food additive because that use has
been permanently and completely 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 ACC petition contained public information and information
collected from companies that produce PC resins to support the claim
that baby bottles and sippy cups manufactured from 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. Specifically, the petition contained the results
of an industry poll showing that the PC resin manufacturers, which
represent over 97 percent of worldwide 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.
III. Comments on the Filing Notice
The Agency provided 60 days for comments on the filing notice. FDA
received six distinct comments from individuals and consumer groups
(FDA received seven comments total, but one represented a corrected
version of a comment submitted earlier). Three of the six comments
exclusively addressed the safety of BPA in food, two of the comments
addressed both safety and abandonment, while one comment addressed only
abandonment. While none of these comments included any information to
indicate that the use of BPA-based PC resins in the manufacture of baby
bottles and sippy cups has not been completely and permanently
abandoned, or to indicate that these uses were not adequately defined,
these comments raised six main issues, discussed further in this
document.
A. The Safety of BPA
As indicated in the filing notice (77 FR 9608 at 9609), because the
petition was based on an assertion of abandonment, the Agency did not
request comments on the safety of the use of PC resins in baby bottles
and sippy cups. Such safety information is not relevant to abandonment
and, therefore, any comments addressing the safety of PC resins were
not considered in the Agency'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).
B. Whether the Subject Uses Are Adequately Defined
1. Baby Bottles
(Comment 1) One comment stated that the Agency did not offer
additional description or clarification of the term ``baby bottles,''
which was defined by ACC as ``infant feeding bottles.'' The comment
stated that this definition failed to identify the full spectrum of
beverage containers from which infants, toddlers, and children consume
beverages.
(Response) The Agency has concluded that the term infant feeding
bottle (baby bottle) adequately defines the specific use of PC resins
that is the subject of the proposed action so that both the scope of
the abandonment and this amendment to the food additive regulation are
clear. FDA agrees that this term does not cover the full spectrum of
beverage containers from which infants, toddlers, and children consume
beverages. However, this spectrum of beverage containers was not the
scope of the petition. Instead, the petition was limited to the use of
PC resins in baby bottles and sippy cups. FDA concludes that the terms
``baby bottle'' and ``infant feeding bottle'' are generally recognized
[[Page 41901]]
by both the general public and the regulated industry and adequately
define this use of PC resins addressed by the petition.
2. Sippy Cups
(Comment 2) The petition defined ``sippy cup'' as a spill-proof cup
designed to help train babies to drink from cups. As stated in the
filing notice (77 FR 9608 at 9609), for the purposes of this petition,
FDA more specifically considers ``sippy cup'' to mean a spill-proof
cup, including its closures and lids, designed to train babies or
toddlers to drink from cups. FDA specifically requested comment on
whether this use of PC resins is adequately defined. Two of the
comments expressed the opinion that the term ``sippy cup'' is narrow or
not inclusive of the different types of bottles and cups used by small
children and toddlers, and defining sippy cups as cups that are spill-
resistant would not cover the use of PC resins in toddler cups (such as
drinking cups without a lid) that do not have this feature. One comment
recommended that the term ``designed for'' be clarified to include both
functionality (e.g., spill-resistant) and aesthetics (e.g., anything
with cartoon characters) in order to cover a broader category of
products. Another comment recommended that the definition of ``sippy
cup'' be expanded to include all cups rated for the target age group.
No comments stated that this particular use of PC resins was not
adequately defined.
(Response) The Agency has determined that the functionality of a
spill-resistant cup is the critical factor in defining the particular
use of PC resins that the petition asserted has been permanently and
completely abandoned. The petition asserted that the use of PC resins
in spill-proof cups has been abandoned. Because the scope of the
petition was limited to functionality, and did not address aesthetics,
FDA concludes that the functionality of spill resistance is the
defining feature of a ``sippy cup'' as contemplated by the petition,
and about which FDA requested comment.
The Agency has concluded that the phrase ``spill proof cups,
including their closures and lids, designed to help train babies or
toddlers to drink from cups (sippy cups)'' adequately defines the
specific use of PC resins that is the subject of the proposed action
and is generally recognized by the regulated industry and the public.
The comments that addressed the term ``sippy cup'' did not assert that
this term is unclear to consumers or industry, or that this use of PC
resins is not adequately defined; instead, the comments opined that any
action taken by FDA should address beverage containers used by children
that are beyond the scope of these terms. FDA agrees that these terms
do not cover the full spectrum of beverage containers from which
infants, toddlers, and children consume beverages. However, this
spectrum of beverage containers was not the scope of the petition.
Instead, the petition was limited to specific uses of PC resins.
C. The Scope of the Uses of PC Resins Addressed by the Petition
(Comment 3) Two comments recommended that the scope of any action
taken by FDA in response to ACC's petition include other products that
an infant or toddler may regularly put in its mouth (e.g., pacifiers,
teethers, tableware) or that may come in contact with breast milk
(e.g., breast pump, pumping supplies, breast milk storage kits).
(Response) The Agency has concluded that it is not appropriate, in
this amendment to the food additive regulations, to address any uses of
PC resins beyond those specified in ACC's petition, for the following
reasons:
The suggested products are beyond the scope of the uses as
described in the petition, about which the petition provided detailed
evidence, and about which FDA requested comment; and
No comments received by FDA provided specific information
to demonstrate that any additional uses of PC resins have been
completely and permanently abandoned.
D. Whether the Subject Uses Have Been Abandoned
(Comment 4) One comment expressed the opinion that PC resins are
still used worldwide in the manufacture of plastics products and,
although the current manufacturers of sippy cups do not currently use
these resins, a new producer may still choose to use these PC resins to
make plastic products. Accordingly, the comment asserts that removing
these uses of PC resins from the food additive regulations leaves the
opportunity for these uses of BPA to go ``unchecked.''
(Response) The Agency does not agree with this comment. First, the
petition provided evidence that the use of PC resins in the manufacture
of baby bottles and sippy cups has been permanently and completely
abandoned, and FDA did not receive any comments demonstrating that
these uses have not been abandoned. The comment addressed uses of PC
resins that are beyond the scope of the petition and this action. A
food is considered to be adulterated if it contains an unapproved food
additive (see section 409 of the FD&C Act). The amendment to Sec.
177.1580 means that FDA's regulations no longer provide for the use of
PC resins in baby bottles and sippy cups.
E. Labeling of BPA Containing Materials
(Comment 5) One comment asserted that because FDA does not require
that manufacturers identify the presence of BPA-containing materials in
their labeling, the general public is defenseless to counter industry
assertions about the abandonment (i.e., the general public has no way
of knowing whether industry has in fact abandoned certain uses of BPA-
containing materials or whether certain products contain BPA), and
recommended that FDA require labeling of all food contact materials
that contain BPA.
(Response) The petition did not request that FDA establish
requirements for the labeling of products manufactured with BPA.
Therefore, this comment is outside the scope of the action requested by
the petition, and FDA did not consider this comment.
F. The Amount of BPA Allowed in the Plastic Products
(Comment 6) One comment expressed the opinion that one way to
determine if PC resins are not present in a plastic product is to
measure the presence of BPA in the product. The comment suggested that,
in addition to granting ACC's petition, FDA should set a limit of the
amount of BPA found in the other suggested plastic products to 0.1
parts per billion.
(Response) The petition did not request that FDA establish limits
for the amount of BPA in certain products. Therefore, this comment is
outside the scope of the action requested by the petition, and FDA did
not consider this comment.
IV. Conclusion
FDA reviewed the data and information in the petition and other
available relevant material to evaluate whether the use of BPA-based PC
resins in the manufacture of baby bottles and sippy cups has been
completely and permanently abandoned. Based on the available
information, the Agency concludes that these uses have been completely
and permanently abandoned. Therefore, the regulations in 21 CFR part
177 should be amended as set forth in this document.
V. Public Disclosure
In accordance with Sec. 171.1(h), the petition and the documents
that FDA considered and relied upon in reaching
[[Page 41902]]
its decision to approve the petition are available for inspection at
the Center for Food Safety and Applied Nutrition by appointment with
the information contact person (see FOR FURTHER INFORMATION CONTACT).
As provided in Sec. 171.1(h), the Agency will delete from the
documents any materials that are not available for public disclosure
before making the documents available for inspection.
VI. Environmental Impact
The Agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 1B4783 (77 FR
9608). No new information or comments have been received that would
affect the Agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VIII. Objections
Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections by (see DATES). Each objection must be
separately numbered, and each numbered objection must specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested must specifically so state. Failure to
request a hearing for any particular objection constitutes a waiver of
the right to a hearing on that objection. Each numbered objection for
which a hearing is requested must include a detailed description and
analysis of the specific factual information intended to be presented
in support of the objection in the event that a hearing is held.
Failure to include such a description and analysis for any particular
objection constitutes a waiver of the right to a hearing on the
objection. It is only necessary to send one set of documents. Identify
documents with the docket number found in brackets in the heading of
this document. Any objections received in response to the regulation
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
List of Subjects in 21 CFR Part 177
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
0
1. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
0
2. Section 177.1580 is amended by adding paragraph (d) to read as
follows:
Sec. 177.1580 Polycarbonate resins.
* * * * *
(d) Polycarbonate resins may be used in accordance with this
section except in infant feeding bottles (baby bottles) and spill-proof
cups, including their closures and lids, designed to help train babies
and toddlers to drink from cups (sippy cups).
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17366 Filed 7-16-12; 8:45 am]
BILLING CODE 4160-01-P