[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Rules and Regulations]
[Pages 83672-83674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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