[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Proposed Rules]
[Pages 60336-60337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16337]


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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; Reopening of the Comment Period; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition, reopening of the comment period; 
correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the notification of petition, published in the 
Federal Register of April 26, 2024, 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. FDA is reopening the comment period to add 
the food additive petition to the docket.

[[Page 60337]]

FDA is also making a correction to the filing notice.

DATES: FDA is reopening the comment period on the notification of 
petition published in the Federal Register of April 26, 2024 (89 FR 
32386). Either electronic or written comments must be submitted by 
September 23, 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 September 23, 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'').

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, 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; Reopening of the Comment 
Period.'' 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 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.'' 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: In the Federal Register of April 26, 2024 
(89 FR 32386), FDA published a notification of filing of 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 FDA 
revoke Sec.  177.1615 (21 CFR 177.1615, ``Polyethylene, fluorinated''). 
Interested persons were originally given until June 25, 2024, to 
comment.
    Following publication of the filing notice in the Federal Register 
of April 26, 2024, FDA was alerted that FAP 3B4837 was not uploaded to 
the docket, which did not allow respondents the ability to view the FAP 
when the notice was published in the Federal Register. Therefore, we 
are reopening the comment period for 60 days (which corresponds to the 
amount of time that the petition was missing from the docket) to allow 
for interested parties to view the FAP posted to the docket.

Correction

    In the Federal Register of Friday, April 26, 2024 (89 FR 32886), in 
FR Doc. 2024-09027, on page 32387, in the second column in the 
paragraph under Section II. ``Request To Repeal 21 CFR part 177.1615,'' 
correct the second sentence to read: ``Specifically, the petitioners 
state that the fluorinated polyethylene manufactured consistent with 
Sec.  177.1615 can produce 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)).''
    We are correcting the sentence to delete the word ``polymeric.''

    Dated: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16337 Filed 7-24-24; 8:45 am]
BILLING CODE 4164-01-P