[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Rules and Regulations]
[Pages 41899-41902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17366]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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