[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Proposed Rules]
[Pages 1856-1857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00410]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2023-C-5679]


Filing of Color Additive Petition From Environmental Defense 
Fund, et al.; Request To Amend the Color Additive Regulations To Remove 
the Solvents Ethylene Dichloride, Methylene Chloride, and 
Trichloroethylene

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 the color additive 
regulations be amended to remove three specified solvents.

DATES: The color additive petition was filed on December 21, 2023. 
Either electronic or written comments must be submitted by March 11, 
2024.

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 March 11, 2024. 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-5679 for ``Filing of Color Additive Petition From 
Environmental Defense Fund, et al.; Request To Amend the Color Additive 
Regulations To Remove the Solvents Ethylene Dichloride, Methylene 
Chloride, and Trichloroethylene.'' 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: 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 4C0327), submitted by 
Environmental Defense Fund, Breast Cancer Prevention Partners, Center 
for Environmental Health, Environmental Working Group, and Lisa 
Lefferts, c/o Lisa Lefferts, Nellysford, VA 22958. The petition 
proposes that we amend Sec. Sec.  73.1 (21 CFR 73.1, ``Diluents in 
color additive mixtures for food use exempt from certification''), 
73.30 (21 CFR 73.30, ``Annatto extract''), 73.345 (21 CFR 73.345, 
``Paprika oleoresin''), and 73.615 (21 CFR 73.615, ``Turmeric 
oleoresin'') to remove the use of three specified solvents.
    The three solvents that are the subject of this petition are:

[[Page 1857]]

    1. Ethylene dichloride (CAS No. 107-06-2);
    2. Methylene chloride (CAS No. 75-09-2); and
    3. Trichloroethylene (CAS No. 79-01-6).

II. Request To Amend 21 CFR Part 73

    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 amend Sec. Sec.  73.1, 73.30, 73.345, and 73.615 to remove ethylene 
dichloride, methylene chloride, and trichloroethylene. Specifically, 
the petitioners state these substances have been found to induce cancer 
in humans or animals and, therefore, are not safe pursuant to section 
721(b)(5)(B) of the FD&C Act (also referred to as the ``Delaney 
Clause''). The Delaney Clause provides, in relevant part, 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 petition is available in the docket. 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 amending Sec. Sec.  73.1, 73.30, 73.345, and 73.615 to remove 
ethylene dichloride, methylene chloride, and trichloroethylene, 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: January 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00410 Filed 1-10-24; 8:45 am]
BILLING CODE 4164-01-P