Federal Register, Volume 87 Issue 138 (Wednesday, July 20, 2022)

[Federal Register Volume 87, Number 138 (Wednesday, July 20, 2022)]
[Notices]
[Pages 43274-43276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15455]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1526]

Fluorinated Polyethylene Containers for Food Contact Use; Request
for Information

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA or we) is opening a
docket to obtain data and information on the use of fluorinated
polyethylene for food contact applications. Specifically, FDA is
seeking scientific data and information on current food contact uses of
fluorinated polyethylene, consumer dietary exposure that may result
from those uses, and safety of certain per- and polyfluoroalkyl
substances that may migrate from fluorinated polyethylene food
containers. The purpose of this request is to ensure that we have
current information to support our review of the use of fluorinated
polyethylene containers used in food contact applications to help
ensure that this use continues to be safe. FDA may use information
submitted in response to this notice to update dietary exposure
estimates and safety assessments for the authorized food contact use of
fluorinated polyethylene.

DATES: Either electronic or written comments and scientific data and
information must be submitted by October 18, 2022.

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 October 18, 2022. 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

[[Page 43275]]

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-2022-N-1526 for ``Fluorinated Polyethylene Containers for Food
Contact Use; Request for Information.'' 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: Sharon Koh-Fallet, Center for Food
Safety and Applied Nutrition, Office of Food Additive Safety, Division
of Food Contact Substances (HFS-275), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 301-796-7732; or Joan
Rothenberg, Center for Food Safety and Applied Nutrition, Office of
Regulations and Policy (HFS-024), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

Fluorinated polyethylene containers manufactured and used in
compliance with our regulation at Sec. 177.1615 (21 CFR 177.1615),
Polyethylene, fluorinated, may be used in certain food contact
applications. Fluorination of polyethylene containers allows for
improved chemical barrier properties in comparison to polyethylene
containers that have not been fluorinated. FDA's regulation, at Sec.
177.1615(a), states that fluorinated polyethylene containers for food
contact use be manufactured only by modifying the surface of the molded
container using fluorine gas in combination with gaseous nitrogen as an
inert diluent. We are aware that some manufacturers of fluorinated
polyethylene produce fluorinated containers through alternative
manufacturing methods, such as using alternative diluent gases such as
oxygen or other gases. These alternative processes for fluorination of
polyethylene do not comply with Sec. 177.1615 and are not lawful for
use in food contact applications.
Testing performed by the Environmental Protection Agency (EPA)
found that certain per- and polyfluoroalkyl substances (PFAS) can form
and migrate from some fluorinated high-density polyethylene (HDPE,
which is a type of polyethylene) containers into the pesticide within
the containers. EPA's testing was conducted on containers that are not
FDA-regulated, specifically containers intended to hold mosquito-
controlling pesticides. EPA detected perfluoroalkyl carboxylic acids
(PFCAs), and analytical studies indicate that PFCAs can result from
fluorination processes that do not comply with FDA's regulations (Ref.
1). PFCAs are a subset of PFAS, that include substances such as
perfluorooctanoic acid (PFOA), which is known to be biopersistent in
animals and humans. Additionally, PFOA is a potential human carcinogen
and known to cause immunotoxicity and reproductive and developmental
toxicity (Refs. 2 and 3).
On August 5, 2021, FDA made available on its website a letter
(https://www.fda.gov/media/151326/download) to manufacturers,
distributors, and food manufacturers that use fluorinated polyethylene
food contact containers reminding them that only fluorinated
polyethylene containers that comply with Sec. 177.1615 are authorized
for food contact use. However, because alternative fluorination
processes exist, there is a possibility that these alternative
fluorination processes are used to manufacture fluorinated polyethylene
containers used to contain food. As such, we reminded food
manufacturers of their responsibility to only use food contact articles
in compliance with FDA's regulations.
Although EPA's testing was of containers not intended to contact
food, it raises questions about the potential for PFAS to form and
migrate from fluorinated polyethylene containers that are intended for
food contact use. As such, we are interested in obtaining information
on current food uses of fluorinated polyethylene containers as well as
information on current manufacturing processes for these containers and
any analytical testing information of substances that may migrate from
fluorinated polyethylene containers to food. This information will
enable us to better understand current food uses, manufacturing
practices, and substances migrating from fluorinated polyethylene
containers and, as appropriate, we may use information submitted in
response

[[Page 43276]]

to this notice to update dietary exposure estimates and safety
assessments for the authorized food contact use of fluorinated
polyethylene. This is consistent with our efforts to increase our
understanding of the potential for PFAS exposure from food and to
reduce dietary exposure to PFAS that may pose a health risk. Current
data and information on these topics will help us advance our public
health mission and further support the current Administration's
comprehensive approach to addressing PFAS and advancing clean air,
water, and food (Ref. 4).

II. Request for Information

We request information on the food contact uses of fluorinated
polyethylene food contact articles, including information on the types
of food or food ingredients with which the articles used are in
contact, any substances migrating from fluorinated polyethylene food
contact articles used in food contact applications, consumer exposure
data, and unpublished safety information. Specifically, we request data
and information concerning:
1. Current food contact uses, including the types of containers and
the food types (e.g., acidic, alcoholic) they may contact, including
use conditions (e.g., time, temperature of contact);
2. Manufacturing conditions for the fluorination process and any
pre- and post-treatment processes, including time, temperature,
pressure, atmospheric conditions, treatment gases (e.g., fluorine or
other chemical gases), and use levels/ratios of treatment gases used
during the manufacturing process;
3. Manufacturing process controls including moisture control
measures and quality control variables monitored during the
fluorination process;
4. Analyses related to pre- and post-treatment of fluorinated
polyethylene containers, including surface chemical analyses,
characterization of surface morphology, and identification of surface
chemical functionalities;
5. Analyses characterizing the fluorinated surface thickness of the
fluorinated layer on the article surface;
6. Analyses characterizing (qualitatively or quantitatively) the
fluorinated polyethylene containers including any analyses for quality
control (e.g., Fourier-Transform Infrared Spectroscopy or other
analyses);
7. Analyses characterizing (qualitatively or quantitatively)
migrating substances from the fluorinated polyethylene containers,
including fully and partially fluorinated low molecular weight
polyethylene oligomers and other migrating substances;
8. Analyses characterizing (qualitatively or quantitatively)
substances migrating from fluorinated polyethylene as a function of the
degree of fluorination of the surface;
9. Analyses estimating consumer exposure from the use of
fluorinated polyethylene containers in food contact, including
substances migrating from fluorinated polyethylene;
10. The safety of fluorinated polyethylene, including unpublished
safety studies on substances that migrate from fluorinated polyethylene
including fully and partially fluorinated low molecular weight
polyethylene oligomers; and
11. Analyses characterizing the polyethylene used to produce the
containers prior to fluorination, including the molecular weight
distribution, the weight-percent units derived from ethylene and other
monomers, monomer ratios, and adjuvant substances (e.g., processing
aids) used in the manufacture of polyethylene polymers.

III. References

The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov . References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website address, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Rand, A.A. and S.A. Mabury, ``Perfluorinated Carboxylic Acids
in Directly Fluorinated High-Density Polyethylene Material,''
Environmental Science & Technology, 2011, vol. 45, pp. 8053-8059.
2. *Agency for Toxic Substances and Disease Registry,
``Toxicological Profile for Perfluoroalkyls,'' May 2021.
3. *The International Agency for Research on Cancer, Monogram
for Perfluorooactanoic Acid, 2017.
4. *Fact Sheet: Biden-Harris Administration Launches Plan to
Combat PFAS Pollution, October 2021. Available at: https://www.whitehouse.gov/briefing-room/statements-releases/2021/10/18/fact-sheet-biden-harris-administration-launches-plan-to-combat-pfas-pollution/.

Dated: July 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15455 Filed 7-19-22; 8:45 am]
BILLING CODE 4164-01-P