81 FR 83672 - Indirect Food Additives: Paper and Paperboard Components

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 225 (November 22, 2016)

Page Range		83672-83674
FR Document		2016-28116

The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of two specific perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods because these uses have been abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of 3M Corporation.

Federal Register, Volume 81 Issue 225 (Tuesday, November 22, 2016)

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Rules and Regulations]
[Pages 83672-83674]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-28116]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. FDA-2016-F-1153]

Indirect Food Additives: Paper and Paperboard Components

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 two
specific perfluoroalkyl containing substances as oil and water
repellents for paper and paperboard for use in contact with aqueous and
fatty foods because these uses have been abandoned. This action is in
response to a petition filed by Keller and Heckman LLP on behalf of 3M
Corporation.

DATES: This rule is effective November 22, 2016. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by December
22, 2016.

ADDRESSES: You may submit objections and requests for a hearing as
follows.

Electronic Submissions

Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on http://www.regulations.gov.
If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper objections submitted to the Division of
Dockets Management, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-F-1153 for ``Indirect Food Additives: Paper and Paperboard
Components.'' Received objections will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments 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,
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1217.

[[Page 83673]]

SUPPLEMENTARY INFORMATION:

I. Background

In a document published in the Federal Register of April 29, 2016
(81 FR 25625), we announced that we filed a food additive petition (FAP
6B4814) submitted on behalf of 3M Corporation (Petitioner) by Keller
and Heckman LLP, 1001 G Street NW., Suite 500 West, Washington, DC
20001. The petition proposed to amend Sec. 176.170 (21 CFR 176.170) to
no longer provide for the use of two different perfluoroalkyl
containing substances as oil and water repellents for paper and
paperboard for use in contact with aqueous and fatty foods because
these uses have been intentionally and permanently abandoned. The two
substances that are the subjects of the petition are as follows:
(1) Ammonium bis (N-ethyl-2-perfluoroalkylsulfonamido ethyl)
phosphates, containing not more than 15 percent ammonium mono (N-ethyl-
2-perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is
more than 95 percent C8 and the salts have a fluorine
content of 50.2 percent to 52.8 percent as determined on a solids
basis; and
(2) Perfluoroalkyl acrylate copolymer (CAS Reg. No. 92265-81-1)
containing 35 to 40 weight percent fluorine, produced by the
copolymerization of ethanaminium, N,N,N-trimethyl-2-[(2-methyl-1-oxo-2-
propenyl)-oxy]-, chloride; 2-propenoic acid, 2-methyl-, oxiranylmethyl
ester; 2-propenoic acid, 2-ethoxyethyl ester; and 2-propenoic acid,
2[[(heptadecafluoro-octyl)sulfonyl]methyl amino]ethyl ester.
In response to food additive petitions submitted by the Petitioner
(33 FR 14544, September 27, 1968; 35 FR 14840, September 24, 1970; 37
FR 9762, May 17, 1972; and 52 FR 3603, February 5, 1987), FDA
authorized certain uses of these two substances as food additives under
Sec. 176.170.

II. Evaluation of Abandonment

Section 409(i) of the Federal, Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(i)) states that we may by regulation establish
the procedure for amending or repealing a food additive regulation, and
that this procedure shall conform to the procedure provided in section
409 for the promulgation of such regulations. FDA's regulations
specific to the administrative actions for food additives provide that
the Commissioner, on his own initiative or on the petition of any
interested person, may propose the issuance of a regulation amending or
repealing a regulation pertaining to a food additive (Sec. 171.130(a)
(21 CFR 171.130(a))). The regulations further provide that any such
petition must 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 must be furnished in the form specified in 21 CFR 171.1 and
171.100 for submitting petitions (Sec. 171.130(b)). Under these
regulations, a petitioner may propose that we 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 and permanent 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 of the food
additive. Instead, the amendment or revocation is based on the fact
that regulatory authorization is no longer necessary because the use of
the food additive 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 to amend the 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 submitted on behalf of 3M Corporation includes the
following information to support the claim that the uses of the two
substances are no longer being introduced into interstate commerce. The
Petitioner provides a statement that the Petitioner does not currently
manufacture the two substances for food contact use in the United
States, and that to the best of the Petitioner's knowledge, the
Petitioner was the sole and exclusive domestic and international
manufacturer of the two substances for the abandoned uses. In addition,
the Petitioner submitted information on its May 2000 voluntary
agreement with the U.S. Environmental Protection Agency to phase out
production of perfluorooctane sulfonate (PFOS); which is used to
produce the two substances (https://nepis.epa.gov/Exe/ZyPDF.cgi/P100LTG6.PDF?Dockey=P100LTG6.PDF). According to the petition, the
Petitioner completed a voluntary phase-out of PFOS production in 2002.
The Petitioner states that it does not intend to manufacture or import,
nor does it maintain an inventory for sale or distribution, of the two
substances for use in food-contact applications in the United States in
the future.

III. Comments on the Filing Notice

We provided 60 days for comments on the filing notice. We received
two comments from an individual and a consumer group. Both comments
raised two 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 with ``Response.''
(Comment 1) One comment asked why we are amending the regulations
if the substances are no longer in use.
(Response) FDA is responding to an FAP, as required under section
409 of the FD&C Act. Amending these food additive regulations addresses
the FAP under the process set forth in the FD&C Act. In the case of
abandonment, regulatory authorization is no longer necessary for these
substances because their use as food additives has been permanently and
completely abandoned. Our action also gives interested parties better
information about what substances are used as food contact substances.
(Comment 2) Another comment asked FDA to remove the approvals of
seven effective food contact notifications for long-chain
perfluorinated compounds.
(Response) We decline to address food contact substances that are
outside the scope of this food additive petition.

IV. Conclusion

We reviewed the data and information in the petition and other
available relevant material to determine whether the use of the two
perfluoroalkyl containing substances as oil and water repellents for
paper and paperboard for use in contact with aqueous and fatty foods
has been permanently and completely abandoned. Based on the available
information, we conclude that the use of these substances has been
permanently and completely abandoned. Therefore, we are amending 21 CFR
part 176 as set forth in this document. Upon the effective date (see
DATES), these food additive uses are no longer authorized.

[[Page 83674]]

V. Public Disclosure

In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.

VI. Analysis of Environmental Impact

We previously considered the environmental effects of this rule, as
stated in the Federal Register of April 29, 2016, notice of petition
for FAP 6B4814. We 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.
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 176

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 re-
delegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

0
1. The authority citation for part 176 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 346, 348, 379e.

Sec. 176.170 [Amended]

0
2. Amend Sec. 176.170 in the table in paragraph (a)(5) by removing the
entries for ``Ammonium bis (N-ethyl-2-perfluoroalkylsulfonamido ethyl)
phosphates'' and ``Perfluoroalkyl acrylate copolymer.''

Dated: November 17, 2016.
Susan Bernard,
Director, Office of Regulations, Policy and Social Science, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2016-28116 Filed 11-21-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Rules and Regulations 83673

SUPPLEMENTARY INFORMATION: (§ 171.130(a) (21 CFR 171.130(a))). The (PFOS); which is used to produce the
regulations further provide that any two substances (https://nepis.epa.gov/
I. Background
such petition must include an assertion Exe/ZyPDF.cgi/P100LTG6.PDF?Dockey=
In a document published in the of facts, supported by data, showing that P100LTG6.PDF). According to the
Federal Register of April 29, 2016 (81 new information exists with respect to petition, the Petitioner completed a
FR 25625), we announced that we filed the food additive or that new uses have voluntary phase-out of PFOS production
a food additive petition (FAP 6B4814) been developed or old uses abandoned, in 2002. The Petitioner states that it
submitted on behalf of 3M Corporation that new data are available as to toxicity does not intend to manufacture or
(Petitioner) by Keller and Heckman LLP, of the chemical, or that experience with import, nor does it maintain an
1001 G Street NW., Suite 500 West, the existing regulation or exemption inventory for sale or distribution, of the
Washington, DC 20001. The petition may justify its amendment or appeal. two substances for use in food-contact
proposed to amend § 176.170 (21 CFR New data must be furnished in the form applications in the United States in the
176.170) to no longer provide for the use specified in 21 CFR 171.1 and 171.100 future.
of two different perfluoroalkyl for submitting petitions (§ 171.130(b)).
containing substances as oil and water Under these regulations, a petitioner III. Comments on the Filing Notice
repellents for paper and paperboard for may propose that we amend a food We provided 60 days for comments
use in contact with aqueous and fatty additive regulation if the petitioner can on the filing notice. We received two
foods because these uses have been demonstrate that there are ‘‘old uses comments from an individual and a
intentionally and permanently abandoned’’ for the relevant food consumer group. Both comments raised
abandoned. The two substances that are additive. Such abandonment must be two issues, which are discussed in the
the subjects of the petition are as complete and permanent for any paragraphs that follow. For ease of
follows: intended uses in the U.S. market. While reading, we preface each comment
(1) Ammonium bis (N-ethyl-2- section 409 of the FD&C Act and discussion with a numbered
perfluoroalkylsulfonamido ethyl) § 171.130 also provide for amending or ‘‘Comment,’’ and each response with
phosphates, containing not more than revoking a food additive regulation ‘‘Response.’’
15 percent ammonium mono (N-ethyl-2- based on safety, an amendment or (Comment 1) One comment asked
perfluoroalkylsulfonamido ethyl) revocation based on abandonment is not why we are amending the regulations if
phosphates, where the alkyl group is based on safety of the food additive. the substances are no longer in use.
more than 95 percent C8 and the salts Instead, the amendment or revocation is (Response) FDA is responding to an
have a fluorine content of 50.2 percent based on the fact that regulatory FAP, as required under section 409 of
to 52.8 percent as determined on a authorization is no longer necessary the FD&C Act. Amending these food
solids basis; and because the use of the food additive has
(2) Perfluoroalkyl acrylate copolymer additive regulations addresses the FAP
been permanently and completely under the process set forth in the FD&C
(CAS Reg. No. 92265–81–1) containing abandoned.
35 to 40 weight percent fluorine, Act. In the case of abandonment,
Abandonment may be based on the
produced by the copolymerization of regulatory authorization is no longer
abandonment of certain authorized food
ethanaminium, N,N,N-trimethyl-2-[(2- necessary for these substances because
additive uses for a substance (e.g., if a
methyl-1-oxo-2-propenyl)-oxy]-, their use as food additives has been
substance is no longer used in certain
chloride; 2-propenoic acid, 2-methyl-, product categories) or on the permanently and completely
oxiranylmethyl ester; 2-propenoic acid, abandonment of all authorized food abandoned. Our action also gives
2-ethoxyethyl ester; and 2-propenoic additive uses of a substance (e.g., if a interested parties better information
acid, 2[[(heptadecafluoro- substance is no longer being about what substances are used as food
octyl)sulfonyl]methyl amino]ethyl ester. manufactured). If a petition seeks to contact substances.
In response to food additive petitions amend the food additive regulations (Comment 2) Another comment asked
submitted by the Petitioner (33 FR based on the abandonment of certain FDA to remove the approvals of seven
14544, September 27, 1968; 35 FR uses of the food additive, such uses effective food contact notifications for
14840, September 24, 1970; 37 FR 9762, must be adequately defined so that both long-chain perfluorinated compounds.
May 17, 1972; and 52 FR 3603, February the scope of the abandonment and any (Response) We decline to address
5, 1987), FDA authorized certain uses of amendment to the food additive food contact substances that are outside
these two substances as food additives regulation are clear. the scope of this food additive petition.
under § 176.170. The petition submitted on behalf of IV. Conclusion
3M Corporation includes the following
II. Evaluation of Abandonment We reviewed the data and information
information to support the claim that
Section 409(i) of the Federal, Food, the uses of the two substances are no in the petition and other available
Drug, and Cosmetic Act (the FD&C Act) longer being introduced into interstate relevant material to determine whether
(21 U.S.C. 348(i)) states that we may by commerce. The Petitioner provides a the use of the two perfluoroalkyl
regulation establish the procedure for statement that the Petitioner does not containing substances as oil and water
amending or repealing a food additive currently manufacture the two repellents for paper and paperboard for
regulation, and that this procedure shall substances for food contact use in the use in contact with aqueous and fatty
conform to the procedure provided in United States, and that to the best of the foods has been permanently and
section 409 for the promulgation of such Petitioner’s knowledge, the Petitioner completely abandoned. Based on the
regulations. FDA’s regulations specific was the sole and exclusive domestic and available information, we conclude that
sradovich on DSK3GMQ082PROD with RULES

to the administrative actions for food international manufacturer of the two the use of these substances has been
additives provide that the substances for the abandoned uses. In permanently and completely
Commissioner, on his own initiative or addition, the Petitioner submitted abandoned. Therefore, we are amending
on the petition of any interested person, information on its May 2000 voluntary 21 CFR part 176 as set forth in this
may propose the issuance of a agreement with the U.S. Environmental document. Upon the effective date (see
regulation amending or repealing a Protection Agency to phase out DATES), these food additive uses are no
regulation pertaining to a food additive production of perfluorooctane sulfonate longer authorized.

VerDate Sep<11>2014 16:34 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\22NOR1.SGM 22NOR1

Document Created: 2018-02-14 08:29:24
Document Modified: 2018-02-14 08:29:24

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective November 22, 2016. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by December 22, 2016.
Contact		Vanee Komolprasert, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1217.
FR Citation		81 FR 83672
CFR Associated		Food Additives and Food Packaging

81 FR 83672 - Indirect Food Additives: Paper and Paperboard Components

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 225 (November 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration