[Federal Register Volume 89, Number 8 (Thursday, January 11, 2024)]
[Proposed Rules]
[Pages 1857-1858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172 and 173

[Docket No. FDA-2023-F-5684]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a food additive petition, submitted by Environmental 
Defense Fund, et al., proposing that the food additive regulations be 
amended to remove four specified solvents.

DATES: The food additive petition was filed on December 21, 2023. 
Submit either electronic or written comments on the filing notice 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 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-F-5684 for ``Filing of Food Additive Petition from 
Environmental Defense Fund, et al.; Request To Amend the Food Additive 
Regulations To Remove the Solvents Benzene, 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

[[Page 1858]]

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 409(b)(5) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food 
additive petition (FAP 4A4839), 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.  172.560 (21 CFR 172.560, ``Modified hop extract''), 172.710 
(21 CFR 172.710, ``Adjuvants for pesticide use dilutions''), 173.230 
(21 CFR 173.230, ``Ethylene dichloride''), 173.255 (21 CFR 172.255, 
``Methylene chloride''), 173.290 (21 CFR 173.290, 
``Trichloroethylene''), and 173.315 (21 CFR 173.315, ``Chemicals used 
in washing or to assist in the peeling of fruits and vegetables'') to 
remove the use of four specified solvents.
    The four solvents that are the subject of this petition are:

    1. Benzene (CAS No. 71-43-2);
    2. Ethylene dichloride (CAS No. 107-06-2);
    3. Methylene chloride (CAS No. 75-09-2); and
    4. Trichloroethylene (CAS No. 79-01-6).

II. Request To Amend 21 CFR Parts 172 and 173

    In accordance with the procedures for amending or repealing a food 
additive regulation in Sec.  171.130 (21 CFR 171.130), the petition 
asks us to amend Sec. Sec.  172.560, 172.710, 173.230, 173.255, 
173.290, and 173.315 to remove benzene, ethylene dichloride, methylene 
chloride, and trichloroethylene. Specifically, the petitioners state 
that these substances have been found to induce cancer in humans or 
animals and, therefore, are not safe pursuant to section 409(c)(3)(A) 
of the FD&C Act (also referred to as the ``Delaney Clause''). The 
Delaney Clause provides that no food additive shall be deemed to be 
safe if it is found to induce cancer when ingested by man or animal, or 
if it is found after tests which are appropriate for the evaluation of 
the safety of food additives, 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.  172.560, 172.710, 173.230, 173.255, 
173.290, and 173.315 to remove benzene, ethylene dichloride, methylene 
chloride, and trichloroethylene, we will publish our decision in the 
Federal Register in accordance with Sec.  171.130.
    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. 2024-00411 Filed 1-10-24; 8:45 am]
BILLING CODE 4164-01-P