Indirect Food Additives: Adhesives and Components of Coatings, 41840-41843 [2013-16684]
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41840
§ 71.1
Federal Register / Vol. 78, No. 134 / Friday, July 12, 2013 / Rules and Regulations
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9W,
Airspace Designations and Reporting
Points, dated August 8, 2012, and
effective September 15, 2012, is
amended as follows:
■
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface.
*
*
*
*
*
ASW TX E5 Presidio, TX [New]
Presidio Lely International Airport, TX
(Lat. 29°38′03″ N., long. 104°21′41″ W.)
That airspace extending upward from 700
feet above the surface within a 6.5-mile
radius of Presidio Lely International Airport,
and within 2 miles each side of the 070°
bearing from the airport extending from the
6.5-mile radius to 13.4 miles east of the
airport; and that airspace extending upward
from 1,200 feet above the surface within a
62.5 mile radius of the airport, excluding that
airspace within Mexico.
Issued in Fort Worth, Texas, on July 8,
2013.
David P. Medina,
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. 2013–16437 Filed 7–11–13; 8:45 am]
BILLING CODE 4910–13–P
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.
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
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SUMMARY:
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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: https://
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 https://
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 https://
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
§ 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-
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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 § 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.’’
(§ 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 §§ 171.1 and 171.100 for
submitting petitions.’’ (§ 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 § 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.
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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
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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 BPAbased 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 https://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
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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 BPAbased 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
§ 175.300 does not restrict the use of
BPA-based epoxy resins as coatings in
packaging for food other than infant
formula.
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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
§ 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.
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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
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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 BPAbased 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 BPAbased 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 § 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 § 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
§ 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 https://
www.regulations.gov.
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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:
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PART 175—INDIRECT FOOD
ADDITIVES: ADHESIVES AND
COMPONENTS OF COATINGS
1. The authority citation for 21 CFR
part 175 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 175.300 is amended by
adding paragraph (i) to read as follows:
■
§ 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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2013–0566]
Drawbridge Operation Regulation;
Trent River, New Bern, NC
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Commander, Fifth Coast
Guard District, has issued a temporary
deviation from the operating schedule
that governs the US 70/Alfred C.
Cunningham Bridge across the Trent
River, mile 0.0, at New Bern, NC. The
deviation allows the bridge draw span
to remain in the closed to navigation
position to accommodate the free
movement of pedestrians and vehicles
during the annual Mumfest celebration.
DATES: This deviation is effective from
9 a.m. to 7 p.m. on October 12, 2013 and
from 9 a.m. to 5 p.m. on October 13,
2013.
SUMMARY:
The docket for this
deviation, [USCG–2013–0566] is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation. You may
also visit the Docket Management
Facility in Room W12–140 on the
ground floor of the Department of
ADDRESSES:
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41843
Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
If
you have questions on this temporary
deviation, call or email Mrs. Jessica
Shea, Bridge Management Specialist,
Fifth Coast Guard District, telephone
(757) 398–6422, email
jessica.c.shea2@uscg.mil. If you have
questions on viewing the docket, call
Barbara Hairston, Program Manager,
Docket Operations, telephone (202)
366–9826.
FOR FURTHER INFORMATION CONTACT:
The Event
Director for the New Bern Mumfest,
with approval from the North Carolina
Department of Transportation, owner of
the drawbridge, has requested a
temporary deviation from the current
operating regulations set out in 33 CFR
117.843(a) to accommodate safe passage
for pedestrians and vehicles during
Mumfest.
The US 70/Alfred C. Cunningham
Bridge across the Trent River, mile 0.0,
a double bascule lift Bridge, in New
Bern, NC, has a vertical clearance in the
closed position of 14 feet, above mean
high water. Under the normal operating
schedule, the US 70/Alfred C.
Cunningham Bridge would open on
signal during this timeframe. However,
under this temporary deviation, the
drawbridge will only be allowed to open
every two hours, on the hour, starting at
9 a.m. and continuing until 7 p.m. on
Saturday, October 12, and 9 a.m. to 5
p.m. on Sunday, October 13, 2013 to
accommodate the New Bern Mumfest.
From 8 p.m. on Saturday, October 12,
until 9 a.m. Sunday, October 13, 2013,
the drawbridge will open on signal.
Vessels able to pass under the closed
span may do so. Mariners are advised to
proceed with caution. The Coast Guard
will inform users of the waterway
through our Local and Broadcast
Notices to Mariners of the limited
operating schedule for the drawbridge
so that vessels can arrange their transits
to minimize any impacts caused by the
temporary deviation. There are no
alternate routes for vessels and the
bridge will be able to open in the event
of an emergency.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Rules and Regulations]
[Pages 41840-41843]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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
[[Page 41841]]
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 https://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
[[Page 41842]]
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
[[Page 41843]]
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 https://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
