Document ID: FDA-2023-C-1487-0003
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
Posted Date: 2023-05-03T04:00Z

[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Proposed Rules]
[Pages 27818-27819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09366]

=======================================================================
-----------------------------------------------------------------------

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a 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.

DATES: The color additive petition was filed on April 14, 2023. Either 
electronic or written comments must be submitted by July 3, 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 July 3, 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-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 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

[[Page 27819]]

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: 

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 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 petition proposes that we repeal the color 
additive regulation for titanium dioxide in Sec.  73.575 (21 CFR 
73.575), which permits the use of titanium dioxide in foods.

II. Request To Repeal Section 73.575

    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 section 73.575 to no longer provide for the use of titanium 
dioxide in foods. The petitioners assert that the intended use of this 
color additive no longer meets the safety standard under 21 CFR 
70.3(i), and cite, as evidence, an opinion by the European Food Safety 
Authority (EFSA) entitled ``Safety assessment of titanium dioxide 
(E171) as a food additive'' that was published in May 2021 (we are 
using EFSA's title for this document, rather than the one cited by the 
petitioners), and other publications.
    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 section 73.575 to 
no longer provide for the safe use of titanium dioxide in foods, 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), which applies to an action to prohibit 
or otherwise restrict or reduce the use of a substance in food, food 
packaging, or cosmetics. In addition, the petitioners have stated that, 
to their knowledge, no extraordinary circumstances exist (see 21 CFR 
25.21). 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: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09366 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P