[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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