Proposed Rule2023-03391
Filing of Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
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Published
February 17, 2023
Effective
November 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Proposed Rules]
[Pages 10245-10246]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03391]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 /
Proposed Rules
[[Page 10245]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 74
[Docket No. FDA-2023-N-0437]
Filing of Color Additive Petition From Center for Science in the
Public Interest, et al.; Request To Revoke Color Additive Listing for
Use of FD&C Red No. 3 in Food and Ingested Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Petition for rulemaking.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Center for Science in the
Public Interest, et al., proposing that FDA repeal the color additive
regulations providing for the use of FD&C Red No. 3 in foods (including
dietary supplements) and in ingested drugs.
DATES: The color additive petition was filed on November 15, 2022.
Either electronic or written comments must be submitted by April 18,
2023.
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 April 18, 2023. 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 comment, 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 instructions 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 objection, 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-2023-N-0437 for ``Filing of Color Additive Petition from Center for
Science in the Public Interest, et al.; Request to Revoke Color
Additive Listing for Use of FD&C Red No. 3 in Food and Ingested
Drugs.'' 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 <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 comment 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: Shayla West-Barnette, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1262.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379e(d)(1)), we are giving notice that we have
filed a color additive petition (CAP 3C0323), submitted by Center for
Science in the Public Interest, Breast Cancer Prevention Partners,
Center for Environmental Health, Center for Food Safety, Chef Ann
Foundation, Children's Advocacy Institute, Consumer Federation of
America, Consumer Reports, Defend Our Health, Environmental Defense
Fund, Environmental Working Group,
[[Page 10246]]
Feingold Association of the United States, Food & Water Watch, Healthy
Babies Bright Futures, Life Time Foundation, Momsrising, Prevention
Institute, Public Citizen, Public Health Institute, Public Interest
Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S.
Birnbaum, and Philip J. Landrigan, c/o Jensen Jose, 1250 I Street NW,
Suite 500, Washington, DC 20005. The petition proposes that we repeal
the color additive regulations for FD&C Red No. 3 in Sec. 74.303 (21
CFR 74.303), which permits the use of FD&C Red No. 3 in foods
(including dietary supplements), and Sec. 74.1303 (21 CFR 74.1303),
which permits the use of FD&C Red No. 3 in ingested drugs.
II. Repeal of Sec. Sec. 74.303 and 74.1303
In accordance with the procedure in section 721(d) of the FD&C Act
for issuance, amendment, or repeal of regulations, the petition asks us
to repeal Sec. Sec. 74.303 and 74.1303 to no longer provide for the
use of FD&C Red No. 3 in foods (including dietary supplements) and in
ingested drugs, respectively. Specifically, the petitioners state that
experimental data show that FD&C Red No. 3 induces cancer when fed to
rats and that FDA concluded such in 1990. The petitioners also state
that subsequent studies and reviews have reinforced FDA's conclusion.
The petitioners cite, as evidence, data and information from the
National Toxicology Program, the Joint Expert Committee on Food
Additives, and the European Commission's Scientific Committee for Food
(which was later replaced by the European Food Safety Authority). The
petitioners also state that there is widespread exposure to U.S.
consumers, particularly children, and that very young children have the
highest exposures to the color additive. The petitioners cite the
Delaney Clause (section 721(b)(5)(B) of the FD&C Act), which provides
that no color additive shall be deemed safe for any use which will or
may result in ingestion of all or part of such additive, if the
additive is found by the Secretary of Health and Human Services
(Secretary) to induce cancer when ingested by man or animal, or if it
is found by the Secretary, after tests which are appropriate for the
evaluation of the safety of additives for use in food, to induce cancer
in man or animal. The petitioners state that the Delaney Clause
obligates FDA to repeal the regulations for FD&C Red No. 3.
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 repealing Sec. Sec. 74.303
and 74.1303 to no longer provide for the use of FD&C Red No. 3, we will
publish our decision in the Federal Register in accordance with 21 CFR
71.20.
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: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03391 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P
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