[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


