Document ID: FDA-2022-F-1108-0001
Agency: fda
Document Type: Proposed Rule
Title: Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University; Filing of Food Additive Petition
Posted Date: 2022-07-11T04:00Z

[Federal Register Volume 87, Number 131 (Monday, July 11, 2022)]
[Proposed Rules]
[Pages 41079-41080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14682]

[[Page 41079]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 174, 175, and 177

[Docket No. FDA-2022-F-1108]

Environmental Defense Fund, Maricel Maffini, Breast Cancer 
Prevention Partners, Clean Water Action/Clean Water Fund, Consumer 
Reports, Endocrine Society, Environmental Working Group, Healthy Babies 
Bright Futures, Linda Birnbaum, and the Nicholas School of the 
Environment at Duke University; Filing of Food Additive Petition

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 petition, submitted by Environmental Defense Fund, 
Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/
Clean Water Fund, Consumer Reports, Endocrine Society, Environmental 
Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the 
Nicholas School of the Environment at Duke University, proposing that 
the food additive regulations be amended to remove or restrict 
authorizations for the use of bisphenol A (BPA).

DATES: The food additive petition was filed on May 2, 2022. Submit 
either electronic or written comments on the filing notice by September 
9, 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 September 9, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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-2022-F-1108 for ``Environmental Defense Fund, Maricel Maffini, 
Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, 
Consumer Reports, Endocrine Society, Environmental Working Group, 
Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School 
of the Environment at Duke University; Filing of Food Additive 
Petition.'' Received comments, those filed in a timely manner (see 
DATES), 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: Marissa Santos, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-8160.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food 
additive petition (FAP 2B4831), submitted by Environmental Defense 
Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water 
Action/Clean Water Fund, Consumer Reports, Endocrine Society, 
Environmental Working Group, Healthy Babies Bright Futures, Linda 
Birnbaum, and the Nicholas School of the Environment at Duke 
University, c/o Mr. Thomas Neltner, 1875 Connecticut Ave. NW, 
Washington, DC 20009. The petition proposes to amend the food additive 
regulations in Sec. Sec.  175.105, 175.300, 177.1440, 177.1580, 
177.1585, 177.2280, and 177.2440 (21 CFR 175.105, 175.300, 177.1440, 
177.1580, 177.1585, 177.2280, and 177.2440); Indirect Food Additives: 
General (part 174 (21 CFR part 174)); Indirect Food Additives: 
Adhesives and Components of Coatings (21 CFR part 175); and

[[Page 41080]]

Indirect Food Additives: Polymers (21 CFR part 177), to remove 
authorizations for the use of BPA in Sec. Sec.  175.105, 175.300, and 
177.2440; establish a migration limit for BPA from the authorized uses 
of BPA in food contact articles in Sec. Sec.  177.1440, 177.1580, 
177.1585, and 177.2280; and add a new provision to part 174 with a 
restriction on the use of BPA, stating that the substance is subject to 
a specific migration limit of 0.5 nanograms per kilogram of food. The 
petition is available in Docket No. FDA-2022-F-1108.

II. Amendment of Sec. Sec.  175.105, 175.300, 177.1440, 177.1580, 
177.1585, 177.2280, and 177.2440 and Addition of New Provision With BPA 
Restriction

    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 amend Sec. Sec.  175.105, 175.300, 177.1440, 177.1580, 
177.1585, 177.2280, and 177.2440 to remove authorizations for the use 
of BPA in Sec. Sec.  175.105, 175.300, and 177.2440; establish a 
migration limit for BPA from the authorized uses of BPA in food contact 
articles in Sec. Sec.  177.1440, 177.1580, 177.1585, and 177.2280; and 
add a new provision to part 174 with a restriction on the use of BPA. 
The petitioners cite, as evidence, a draft opinion by the European Food 
Safety Authority (EFSA), which analyzed studies related to the health 
effects of dietary BPA exposure that were published between January 1, 
2013, through October 15, 2018. EFSA's draft opinion entitled ``Re-
evaluation of the risks to public health related to the presence of 
bisphenol (BPA) in foodstuffs,'' was published in December 2021 for 
public comment. Based on the analysis in the draft EFSA opinion, the 
petitioners conclude that the use of BPA in food and food contact 
articles is toxic and disrupts the ``proper functioning of the immune 
and reproductive systems.'' To support their conclusion, the 
petitioners also cite publications referred to in comments to EFSA on 
the draft opinion and an epidemiology study that petitioners assert 
show an association of in utero exposure to BPA with an increased risk 
of asthma and wheezing in school-age girls.
    We invite comments, additional scientific data, and other 
information related to the issues raised by this petition. If we 
determine that the available data justify removing authorizations for 
the use of BPA as listed under Sec. Sec.  175.105, 175.300, and 
177.2440; establishing a migration limit for BPA from authorized uses 
of BPA in food contact articles as listed under Sec. Sec.  177.1440, 
177.1580, 177.1585, and 177.2280; or adding a new provision with a 
restriction on the use of BPA, 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) because this action would prohibit or 
otherwise restrict the use of a substance in food packaging. 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: July 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14682 Filed 7-8-22; 8:45 am]
BILLING CODE 4164-01-P