[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Rules and Regulations]
[Pages 5767-5768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2023-F-5500]
Food Additives Permitted in Feed and Drinking Water of Animals;
Chromium Propionate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of chromium
propionate as a source of chromium in turkey feed. This action is in
response to a food additive petition filed by Kemin Industries, Inc.
DATES: This rule is effective January 30, 2024. See section V for
further information on the filing of objections. Either electronic or
written objections and requests for a hearing on the final rule must be
submitted by February 29, 2024.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections 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
February 29, 2024. Objections 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 objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting objections. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection 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 objection, that information will be
posted on https://www.regulations.gov.
If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection 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 objections 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-F-5500 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Chromium Propionate.'' Received objections, those
filed in a timely manner (see ADDRESSES), 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 an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies in 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.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of objections. 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 objections 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: Wasima Wahid, Center for Veterinary
Medicine (HFV-221), Food and Drug Administration, 12225 Wilkins Avenue,
Rockville, MD 20852, 240-402-5857, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of July 27, 2023
(88 FR 48406), FDA announced that we had filed a food additive petition
(animal use) (FAP 2318) submitted by Kemin Industries, Inc.; 1900 Scott
Ave., Des Moines, IA 50317. The petition proposed that the regulations
for food additives permitted in feed and drinking water of animals be
amended to provide for the safe use of chromium propionate as a source
of chromium in turkey feed.
II. Conclusion
FDA concludes that the data establish the safety and utility of
chromium
[[Page 5768]]
propionate as a source of chromium in turkey feed and that the food
additive regulations should be amended as set forth in this document.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petition
and documents we considered and relied upon in reaching our decision to
approve the petition will be made available for public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in Sec. 571.1(h), we
will delete from the documents any materials that are not available for
public disclosure.
IV. Analysis of Environmental Impact
The Agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment and that an environmental
impact statement is not required. The Agency's finding of no
significant impact and the evidence supporting that finding, contained
in an environmental assessment, may be seen in the Dockets Management
Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
V. Objections and Hearing Requests
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
573 is amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for part 573 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. In Sec. 573.304, revise the section heading and paragraphs (b)(1),
(d)(3)(i), and (e)(2)(ii)(A) to read as follows:
Sec. 573.304 Chromium propionate.
* * * * *
(b) * * *
(1) In complete feed for broiler chickens and growing turkeys at a
level not to exceed 0.2 milligrams (mg) of chromium from chromium
propionate per kilogram feed.
* * * * *
(d) * * *
(3) * * *
(i) A level of 0.2 ppm in complete feed for broiler chickens and
growing turkeys.
* * * * *
(e) * * *
(2) * * *
(ii) * * *
(A) For feed for broiler chickens and growing turkeys, ``Chromium
from all sources of supplemental chromium cannot exceed 0.2 parts per
million of the complete feed.''
* * * * *
Dated: January 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01796 Filed 1-29-24; 8:45 am]
BILLING CODE 4164-01-P