[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Proposed Rules]
[Pages 32386-32387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. FDA-2024-F-1912]


Filing of Food Additive Petition From Environmental Defense Fund, 
Breast Cancer Prevention Partners, Center for Food Safety, 
Environmental Working Group, Tom Neltner, and Maricel Maffini; Request 
To Amend the Food Additive Regulations To Remove Authorization of 
Fluorinated Polyethylene

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a food additive petition, submitted by Environmental 
Defense Fund, et al., proposing that the food additive regulations be 
amended to remove fluorinated polyethylene.

DATES: The food additive petition was filed on April 17, 2024. Either 
electronic or written comments must be submitted by June 25, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 25, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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'').

[[Page 32387]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2024-F-1912 for ``Filing of Food Additive Petition from 
Environmental Defense Fund, et al.; Request to Amend the Food Additive 
Regulations to Remove Fluorinated Polyethylene.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comment 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.'' We will review 
this copy, including the claimed confidential information, in our 
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 https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. 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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Lillian Mawby, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 301-796-4041.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have 
filed a food additive petition (FAP 3B4837), submitted by Environmental 
Defense Fund, Breast Cancer Prevention Partners, Center for Food 
Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini, 
c/o Maricel Maffini, Frederick, MD 21701. The petition proposes that we 
revoke Sec.  177.1615 (21 CFR 177.1615, ``Polyethylene, fluorinated'').

II. Request To Repeal 21 CFR Part 177.1615

    In accordance with the procedures for amending or repealing a food 
additive regulation in Sec.  171.130 (21 CFR 171.130), the petition 
asks us to repeal Sec.  177.1615. Specifically, the petitioners state 
that the fluorinated polyethylene manufactured consistent with Sec.  
177.1615 can produce polymeric per- and poly-fluorinated alkyl 
substances that can migrate to food and, therefore, are not safe 
pursuant to section 409(c)(5) of the FD&C Act (21 U.S.C. 348(c)(5)).
    The petition is available in the docket. We invite comments, 
additional scientific data, and other information related to the issues 
raised by this petition. If we determine that the available data 
justifies repealing Sec.  177.1615, we will publish our decision in the 
Federal Register in accordance with Sec.  171.130.
    The petitioners have claimed that this action is categorically 
excluded under 21 CFR 25.32(m), which applies to an action to prohibit 
or otherwise restrict or reduce the use of a substance in food, food 
packaging, or cosmetics. In addition, the petitioners have stated that, 
to their knowledge, no extraordinary circumstances exist. If FDA 
determines a categorical exclusion applies, neither an environmental 
assessment nor an environmental impact statement is required. If FDA 
determines a categorical exclusion does not apply, we will request an 
environmental assessment and make it available for public inspection.

    Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09027 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P