Document ID: FDA-2023-N-0437-0001
Agency: fda
Document Type: Proposed Rule
Title: 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
Posted Date: 2023-02-17T05:00Z

[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 [www.gpo.gov]
[FR Doc No: 2023-03391]

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 Proposed Rules
                                                 Federal Register
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 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 https://www.regulations.gov 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:
     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 comment, 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 instructions 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 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 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 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 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: 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