Document ID: FDA-2023-C-1487-0013
Agency: fda
Document Type: Proposed Rule
Title: Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive
Listing for Use of Titanium Dioxide in Food; Extension of Comment Period
Posted Date: 2023-06-28T04:00Z

[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Proposed Rules]
[Pages 41870-41871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13773]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2023-C-1487]

Filing of Color Additive Petition From Environmental Defense 
Fund, et al.; Request To Revoke Color Additive Listing for Use of 
Titanium Dioxide in Food; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the color additive petition for which we published a 
notice of filing in the Federal Register on May 3, 2023. In the notice, 
FDA requested comments on a filed color additive petition submitted by 
Environmental Defense Fund, et al., proposing that FDA repeal the color 
additive regulation providing for the use of titanium dioxide in foods. 
We are taking this action in response to requests for an extension to 
allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the color additive 
petition for which a notice of filing was published in the Federal 
Register of May 3, 2023 (88 FR 27818). Either electronic or written 
comments must be submitted by September 1, 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 September 1, 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 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-2023-C-1487 for ``Filing of Color Additive Petition From 
Environmental Defense Fund, et al.; Request To Revoke Color Additive 
Listing for Use of Titanium Dioxide in Food.'' 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: Paulette M. Gaynor, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1192.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 3, 2023 (88 
FR 27819), we published a notice of filing of a color additive petition 
with a 60-day comment period. We explained that, under section 
721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379e(d)(1)), we were giving notice that we had filed a color additive 
petition (CAP 3C0325), submitted by Environmental Defense Fund, Center 
for Environmental Health, Center for Food Safety, Center for Science in 
the Public Interest, and Environmental Working Group, c/o Tom Neltner, 
1875 Connecticut Ave. NW, Washington, DC 20009. The color additive 
petition proposes that we repeal the color additive regulation for 
titanium dioxide in 21 CFR 73.575, which permits the use of titanium 
dioxide in foods.

[[Page 41871]]

    We have received requests for a 60-day extension of the comment 
period for the color additive petition. We have considered these 
requests and are extending the comment period for the color additive 
petition until September 1, 2023. We believe that a 60-day extension 
allows adequate time for interested persons to submit comments without 
significantly delaying a response to this petition.

    Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13773 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P