[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