Proposed Rule2024-16337
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 25, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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. FDA is also making a correction to the filing notice.
Full Text
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<title>Federal Register, Volume 89 Issue 143 (Thursday, July 25, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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