[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Proposed Rules]
[Pages 25625-25627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

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


3M Corporation; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Keller and Heckman LLP on 
behalf of 3M Corporation (Petitioner), requesting that we amend our 
food additive regulations to no longer provide for the use of two 
different perfluoroalkyl containing substances as water and oil 
repellents for paper and paperboard in contact with aqueous and fatty 
foods because these uses have been abandoned.

DATES: Submit either electronic or written comments by June 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
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 comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment 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 comments submitted to the Division of 
Dockets Management, FDA will post your comment, 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 ``Filing of Food Additive Petition: 3M 
Corporation.'' Received comments 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 a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments 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, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1217.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have 
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 proposes that we 
amend 21 CFR 176.170 to no longer provide for the use of two different 
perfluoroalkyl containing substances as components of paper and 
paperboard in contact with aqueous and fatty foods because these uses 
have been

[[Page 25626]]

intentionally and permanently abandoned. The two petitioned substances 
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.

FDA authorized use of these two substances under 21 CFR 176.170 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).

II. Abandonment

    Under section 409(i) of the FD&C Act, we ``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 that the 
Commissioner, on his own initiative or on the petition of any 
interested person, under 21 CFR part 10, 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 that 
any such petition shall include an assertion of facts, supported by 
data, showing that new information exists with respect to the food 
additive or that new uses have been developed or old uses abandoned, 
that new data are available as to toxicity of the chemical, or that 
experience with the existing regulation or exemption may justify its 
amendment or appeal. New data shall be furnished in the form specified 
in 21 CFR 171.1 and 171.100 for submitting petitions (21 CFR 
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 for any intended uses in the U.S. market. 
While section 409 of the FD&C Act and Sec.  171.130 also provide for 
amending or revoking a food additive regulation based on safety, an 
amendment or revocation based on abandonment is not based on safety, 
but is based on the fact that regulatory authorization is no longer 
necessary because the use of the food additive has been abandoned.
    Abandonment may be based on the abandonment of certain authorized 
food additive uses for a substance (e.g., if a substance is no longer 
used in certain product categories), or on the abandonment of all 
authorized food additive uses of a substance (e.g., if a substance is 
no longer being manufactured). If a petition seeks an amendment to a 
food additive regulation based on the abandonment of certain uses of 
the food additive, such uses must be adequately defined so that both 
the scope of the abandonment and any amendment to the food additive 
regulation are clear.
    The petition submitted on behalf of 3M Corporation includes the 
following information to support the claim that the uses of the two 
respective substances are no longer being introduced into the U.S. 
market. The Petitioner provides a statement that, to the best of the 
Petitioner's knowledge, the Petitioner was the sole and exclusive 
domestic and international manufacturer of the two respective 
substances for the abandoned uses and that the Petitioner does not 
currently manufacture them for food contact use in the U. S. In 
addition, the Petitioner submitted information on its May 2000 
agreement with the U.S. Environmental Protection Agency (EPA) to 
voluntarily phase out production of perfluorooctane sulfonate (PFOS), 
which is used to produce the two petitioned substances (https://www.epa.gov/sites/production/files/2014-04/documents/factsheet_contaminant_pfos_pfoa_march2014.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 respective substances for use in food-contact 
applications in the U.S. in the future.
    We expressly request comments on the Petitioner's request to amend 
21 CFR 176.170 of the food additive regulations to no longer permit the 
use of the two respective perfluoroalkyl containing substances as water 
and oil repellants for paper and paperboard in contact with aqueous and 
fatty foods. More specifically, these two petitioned substances as 
identified in this section may currently be used as components of the 
uncoated or coated food-contact surface of paper and paperboard for use 
in contact with aqueous and fatty foods, subject to the provisions of 
21 CFR 176.170. As noted, the basis for the proposed amendment is that 
the uses of the respective substances have been permanently and 
completely abandoned. Accordingly, we request comments that address 
whether these uses of the respective substances have been completely 
abandoned, such as information on whether food-contact paper and 
paperboard containing the two respective substances are currently being 
introduced or delivered for introduction into the U.S. market. 
Furthermore, we request comments on whether the uses that are the 
subject of the petition have been adequately defined. We are not aware 
of information that suggests continued use of the respective substances 
as water and oil repellents for paper and paperboard in contact with 
aqueous and fatty foods. We are providing the public with 60 days to 
submit comments. We anticipate that some interested persons may wish to 
provide FDA with certain information they consider to be trade secret 
or confidential commercial information (CCI) that would be exempt under 
Exemption 4 of the Freedom of Information Act (5 U.S.C. 552). 
Interested persons may claim information that is submitted to FDA as 
CCI or trade secret by clearly marking both the document and the 
specific information as ``confidential.'' Information so marked will 
not be disclosed except in accordance with the Freedom of Information 
Act (5 U.S.C. 552) and the FDA's disclosure regulations (21 CFR part 
20). For electronic submissions to http://www.regulations.gov, indicate 
in the ``comments'' box of the appropriate docket that your submission 
contains confidential information. Interested persons must also submit 
a copy of the comment that does not contain the information claimed as 
confidential for inclusion in the public version of the official 
record. Information not marked confidential will be included in the 
public version of the official record without prior notice.
    We are not requesting comments on the safety of the uses of these 
two perfluoroalkyl containing substances because, as discussed 
previously in this document, such information is not

[[Page 25627]]

relevant to abandonment, which is the basis of the proposed action. Any 
comments addressing the safety of the two perfluoroalkyl containing 
substances or containing safety information on these substances will 
not be considered in our evaluation of this petition.
    We have 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. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: April 22, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Additive 
Safety and Applied Nutrition.
[FR Doc. 2016-09932 Filed 4-28-16; 8:45 am]
 BILLING CODE 4164-01-P