[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Rules and Regulations]
[Pages 41840-41843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. FDA-2012-F-0728]


Indirect Food Additives: Adhesives and Components of Coatings

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food additive regulations 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. We are taking this action in 
response to a petition dated March 16, 2012.

DATES: This rule is effective July 12, 2013. See section VIII of this 
document for further information on the filing of objections. Submit 
either electronic or written objections and requests for a hearing by 
August 12, 2013.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by Docket No. FDA-2012-F-0728, 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 objections.

Written Submissions

    Submit written objections in the following ways:
     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 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 objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
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 document published in the Federal Register of July 17, 2012 
(77 FR 41953), we announced that food additive petition (FAP 2B4791) 
had been filed by then U.S. Representative Edward J. Markey, House of 
Representatives, 2108 Rayburn House Office Building, Washington, DC 
20515-2107. The petition proposed 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 abandoned. BPA-based epoxy resins 
are formed by the reaction of 4,4'-isopropylidenediphenol (i.e., BPA), 
and epichlorohydrin. BPA-based epoxy resins may be safely used as the 
food-contact surfaces 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.  175.300.

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.'' Our 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 repeal. 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 for the specific 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

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amendment to food additive regulations 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 contained public information and information collected 
from a survey of all 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 and that 
infant formula products with packaging containing BPA-based epoxy 
resins are not being introduced into the U.S. market. According to the 
petition, the manufacturers identified in the survey accounted for 100 
percent of the current infant formula market in the United States.

III. Comments on the Filing Notice

    We provided 60 days for comments on the filing notice. We received 
21 comments from individuals, consumer groups, and trade associations. 
Eighteen comments supported the rulemaking based on concerns regarding 
the safety of BPA in food, six comments addressed both safety and 
abandonment, while one comment addressed only abandonment. Three 
comments opposed the rulemaking, asserting that the use of BPA-based 
epoxy resins as coatings in packaging for infant formula has not been 
permanently and completely abandoned. These supporting and opposing 
comments have raised seven main issues, which are discussed in the 
paragraphs that follow. For ease of reading, we preface each comment 
discussion with a numbered ``Comment,'' and each response by a 
corresponding numbered ``Response.'' We have numbered each comment 
discussion to help distinguish among different topics. The number 
assigned is for organizational purposes only and does not signify any 
individual comment's value, importance, or the order in which it was 
received.

A. The Safety of BPA

    (Comment 1) Eighteen distinct comments (representing more than 
7,200 individuals who submitted form letters) supported the rulemaking 
because they asserted that BPA exposure has been reported to be 
associated with a wide range of adverse health issues. One comment 
supported our commitment to study the significant emerging science 
around BPA, and encouraged us to expand the scope of its review beyond 
just infants, small children, and other vulnerable populations. Nine 
comments urged us to immediately release our safety assessment of BPA.
    (Response) As indicated in the filing notice (77 FR 41953), because 
the petition was based on an assertion of abandonment, we did not 
request comments on the safety of the use of BPA-based epoxy resins as 
coatings in packaging for infant formula. Such safety information is 
not relevant to abandonment and, therefore, any comments addressing the 
safety of BPA-based epoxy resins were not considered in our evaluation 
of this petition. Separate from our consideration of this petition, we 
are actively assessing the safety of BPA (see 75 FR 17145; April 5, 
2010; see also http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm) Any comments regarding the safety of BPA should be sent 
in writing to the Division of Dockets Management (see ADDRESSES) and 
include Docket No. FDA-2010-N-0100.

B. Whether the Subject Uses Have Been Abandoned

    (Comment 2) Three distinct comments, submitted by trade 
associations, opposed the rulemaking. These comments asserted that the 
use of BPA-based epoxy resins as coatings in packaging for infant 
formula has not been intentionally, permanently, and completely 
abandoned.
    Specifically, two comments asserted that the petition does not 
adequately establish that the use of BPA-based epoxy resins as coatings 
in infant formula packaging has been intentionally, permanently, and 
completely abandoned because, the comments asserted, there remains a 
desire on the part of can manufacturers to maintain BPA-based epoxy 
resins as an option for future use as coatings in infant formula 
packaging.
    The third comment asserted that the petition's proposed amendment 
is premature and unnecessary at this time, and mere non-use does not 
establish abandonment. This comment asserted that not all infant 
formula manufacturers believe they have permanently ``abandoned'' the 
use of packaging made using BPA.
    (Response) We concluded that the three opposing comments raised 
significant questions regarding whether this use has been completely 
abandoned because these trade associations likely represent the 
opinions of their respective members that include the packaging 
suppliers and the infant formula manufacturers. We therefore asked the 
petitioner to provide additional data in support of the assertion that 
the use of BPA-based epoxy resins as coatings in infant formula 
packaging has been completely abandoned. We needed this new information 
to evaluate the comments asserting that, while infant formula 
manufacturers currently do not use BPA as a component of infant formula 
packaging, they have not abandoned this use. In response to our 
request, the petitioner subsequently amended the petition to include a 
new survey issued to the four infant formula manufacturers in the 
United States. These four infant formula manufacturers account for 100 
percent of the current infant formula market. The survey specifically 
addressed whether these manufacturers have stopped the use of BPA-based 
epoxy coatings in infant formula packaging, and whether they have 
specific plans to reintroduce the use of BPA-based epoxy resins in 
their infant formula packaging in the future.
    The amendment to the petition included a letter from one infant 
formula manufacturer that indicated that while it has no specific plans 
to use packaging materials with BPA in the future, it reserves the 
right to do so in the future should the circumstances warrant it. We 
considered whether this comment demonstrated that the use of BPA-based 
epoxy coatings in infant formula packaging has not been permanently and 
completely abandoned. We concluded that, because the comment did not 
indicate that the manufacturer had specific plans to use BPA-based 
epoxy coatings in the future, it did not demonstrate that this use has 
not been permanently and completely abandoned. We conclude that a mere 
assertion of a right to unspecified, hypothetical future use of an 
additive does not demonstrate that, at the present time, there is 
evidence that this use has not been permanently and completely 
abandoned. We emphasize that our determination that this use of BPA-
based epoxy resins has been abandoned is made without prejudice to a 
future filing based on the safety of this use. A manufacturer could 
seek approval, establishing safe conditions of use for BPA-based epoxy 
coatings in infant formula packaging, via the food contact notification 
process.

C. Impact of the Rulemaking

    (Comment 3) One comment opposed the rulemaking, expressing a 
concern that the rulemaking could impact consumer confidence 
negatively, restrict the wide range of canned food and beverages 
available to consumers, and

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potentially put workers out of jobs in the United States.
    (Response) We disagree with the comment for the following reasons. 
First, this rulemaking is premised on FDA's conclusion that the infant 
formula manufacturers have completely and permanently abandoned the use 
of BPA-based epoxy resins as coatings in packaging for infant formula. 
Because this use has been abandoned, the rulemaking will not impact the 
range of canned food and beverages currently available to consumers and 
will not affect jobs currently held in the United States. Further, the 
amendment to Sec.  175.300 does not restrict the use of BPA-based epoxy 
resins as coatings in packaging for food other than infant formula.

D. Alternatives to BPA-Based Epoxy Resins

    (Comment 4) Two comments supported the rule because alternatives to 
BPA-based epoxy resins as coatings in packaging for infant formula are 
available. However, another comment opposed the rule because the 
industry does not want to foreclose access to a safe material whose use 
may be necessary in the future, reasoning that if a current alternative 
to BPA-based packaging proves to have inadequate performance or becomes 
unavailable, the infant formula producers will need access to other 
safe and proven effective packaging options to ensure the continued 
supply of safe infant formula.
    (Response) We are aware that alternatives to the use of BPA-based 
epoxy resins as coatings are listed in Sec.  175.300, and some are 
being used to replace the BPA-based coatings in infant formula 
packaging. However, this information is not relevant to whether the use 
of BPA-based epoxy resins as coatings in infant formula packaging has 
been abandoned. As discussed in more detail previously, we have 
concluded that, because we did not receive any information from infant 
formula manufacturers that communicated specific plans to use BPA-based 
epoxy resins in their products in the future, we have no information to 
indicate that this use has not been completely and permanently 
abandoned.
    (Comment 5) One comment stated that many consumers have opted to 
use glass baby bottles, given that glass is the only widely used 
packaging designated by FDA as generally recognized as safe.
    (Response) This comment pertains to baby bottles and is not 
relevant to whether the use of BPA-based epoxy resins as coatings in 
infant formula packaging has been abandoned. Therefore, FDA did not 
consider this comment.

E. The Scope of the Use of BPA-Based Epoxy Resin Addressed by the 
Petition

    (Comment 6) One comment stated that more BPA-containing products 
should be banned. Ten comments asserted that the rulemaking does not go 
far enough in protecting the health of infants. This comment stated 
that, because babies are also being exposed to BPA through baby food 
contained in glass jars with BPA-based liners for lids, as well as from 
cans and reusable food containers, FDA should remove BPA from all food 
packaging.
    (Response) We have concluded that it is not appropriate, in this 
amendment to the food additive regulations, to address any uses of BPA-
based food packaging materials beyond that specified in the petition, 
for the following reasons:
     A consideration of other BPA-based food packaging 
materials is beyond the scope of the petition and the evidence 
submitted with the petition, about which FDA requested and received 
comment.
     We did not receive comments providing specific information 
to demonstrate that any additional uses of other BPA-based food 
packaging materials have been completely and permanently abandoned.

F. Labeling of BPA-Containing Packaging Materials

    (Comment 7) One comment asserted that consumers have a need to see 
what is in food, and proper, precise, and truthful labeling is a must. 
Therefore, the comment asserted that all products should be labeled so 
as to give the consumer a choice. Another comment recommended that 
labeling be required for food packaging materials that contain BPA.
    (Response) The petition did not request that FDA establish 
requirements for the labeling of products manufactured with BPA. 
Therefore, these comments are outside the scope of the action requested 
by the petition, and FDA did not consider these comments.

G. Future Presence of BPA in Infant Formula Packaging

    (Comment 8) One comment asserted that if the petition is granted 
and food additive regulations are amended to no longer provide for the 
use of BPA-based epoxy resins as coatings in infant formula packaging, 
it would raise concerns about the possible implications of current or 
future presence of BPA in infant formula packaging as a result of 
environmental contamination. Because no specific level was included in 
the petition, the comment asserted that the detection of any BPA level 
in infant formula packaging could result in an adulterated product. The 
comment asked that we explain how we will handle reports of detectable 
levels of BPA in infant formula packaging that may be due to 
environmental contamination.
    (Response) This comment is not relevant to whether the use of BPA-
based epoxy resins as coatings in infant formula packaging has been 
abandoned. The focus of this amendment is to no longer provide for the 
intentional use of BPA-based epoxy resins as coatings in infant formula 
packaging. However, we note that it is highly unlikely that BPA-based 
epoxy resins will be present in infant formula packaging as a result of 
environmental contamination when BPA-based epoxy resins are not being 
used as components in the manufacture of infant formula packaging. If 
FDA identifies the presence of BPA-based epoxy resins in infant formula 
packaging in the future, FDA will determine whether such presence 
causes an infant formula product to be adulterated under the FD&C Act.

IV. Conclusion

    FDA reviewed the data and information in the petition and other 
available relevant material to determine whether the use of BPA-based 
epoxy resins as coatings in packaging for infant formula has been 
permanently and completely abandoned. Based on the available 
information, we conclude that this use has been permanently and 
completely abandoned. Therefore, we are amending Sec.  175.300 to no 
longer provide for the use of BPA-based epoxy resins as coatings in 
packaging for infant formula.

V. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition will be made 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

    We previously considered the environmental effects of this rule, as 
stated in the notice of petition for FAP 2B4791 (77 FR 41953 at 41954). 
We

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stated that we had 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'' such that neither an 
environmental assessment nor an environmental impact statement is 
required. We have not received any new information or comments that 
would affect our previous determination.

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

    If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
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, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 175

    Adhesives, Food additives, Food packaging.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
175 is amended as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

0
1. The authority citation for 21 CFR part 175 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 379e.

0
2. Section 175.300 is amended by adding paragraph (i) to read as 
follows:


Sec.  175.300  Resinous and polymeric coatings.

* * * * *
    (i) Epoxy resins derived by the reaction of 4,4'-
isopropylidenediphenol and epichlorohydrin, as described in paragraph 
(b)(3)(viii)(a) of this section, may be used in accordance with this 
section except as coatings in packaging for powdered and liquid infant 
formula.

    Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16684 Filed 7-11-13; 8:45 am]
BILLING CODE 4160-01-P