Proposed Rule2024-00410
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 11, 2024
Effective
December 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 8 (Thursday, January 11, 2024)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
</pre></body>
</html>Indexed from Federal Register on January 11, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.