Rule2025-08864
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium
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
May 19, 2025
Effective
May 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens. This action is in response to a food additive petition filed by Zinpro Corp.
Full Text
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<title>Federal Register, Volume 90 Issue 95 (Monday, May 19, 2025)</title>
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[Federal Register Volume 90, Number 95 (Monday, May 19, 2025)]
[Rules and Regulations]
[Pages 21219-21221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08864]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2014-F-1184]
Food Additives Permitted in Feed and Drinking Water of Animals;
Selenium
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; order.
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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 zinc L-
selenomethionine as a source of selenium in complete feed for broiler
chickens. This action is in response to a food additive petition filed
by Zinpro Corp.
DATES: This order is effective May 19, 2025. See section V, Objections
and Hearing Requests, for further information on the filing of
objections. Either electronic or written objections and requests for a
hearing on the final amendment must be submitted by June 18, 2025.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections 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 June
18, 2025. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting objections. Objections 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<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 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-2014-F-1184 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Selenium.'' 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 <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 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
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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 <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 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: <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: Megan Hall, Center for Veterinary
Medicine, Food and Drug Administration, 12225 Wilkins Ave., Rockville,
MD 20852, 240-796-3801, <a href="/cdn-cgi/l/email-protection#04496163656a2a4c656868446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="7a371f1d1b1454321b16163a1c1e1b54121209541d150c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of August 21, 2014
(79 FR 49465), FDA announced that we had filed a food additive petition
(animal use) (FAP 2285) submitted by Zinpro Corp., 10400 Viking Dr.,
Suite 240, Eden Prairie, MN 55344. 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 zinc L-
selenomethionine as a source of selenium in complete feed for broiler
chickens.
II. Conclusion
FDA concludes that the data establish the safety and utility of
zinc L-selenomethionine as a source of selenium in complete feed for
broiler chickens and that the food additive regulations should be
amended as set forth in this document. This final order is expected to
result in expanded production options and is considered an E.O. 14192
deregulatory action.
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
We have determined under 21 CFR 25.32(r) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
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. 573.920, revise paragraphs (a)(6) and (b) and add paragraph
(i) to read as follows:
Sec. 573.920 Selenium.
(a) * * *
(6) Paragraphs (b) through (i) of this section provide the
currently acceptable levels of selenium supplementation.
(b) The food additive selenium is a nutrient administered in animal
feed as sodium selenite or sodium selenate as provided in paragraph (c)
of this section, as a controlled-release sodium selenite bolus as
provided in paragraph (f) of this section, as selenium yeast as
provided in paragraph (g) of this section, as selenomethionine hydroxy
analogue as provided in paragraph (h) of this section, or as zinc-L-
selenomethionine complex as provided in paragraph (i) of this section.
* * * * *
(i) Zinc-L-selenomethionine complex [(2S)-2-amino-4-
(methylseleno)butanoate zinc chloride], is manufactured by the reaction
of a soluble zinc salt with chemically synthesized L-selenomethionine
at an appropriate stoichiometric ratio. The additive is produced in
liquid form and consists of not less than 19 percent (weight/weight) of
L-selenomethionine.
(1) The zinc-L-selenomethionine complex meets the following
specifications:
(i) Arsenic, not more than 0.5 ppm;
(ii) Cadmium, not more than 1 ppm;
(iii) Lead, not more than 1 ppm; and
(iv) Mercury, not more than 0.1 ppm.
(2) Selenium, as zinc-L-selenomethionine complex, is added to
complete feed for broiler chickens at a level not to exceed 0.3 ppm.
(3) The additive, as zinc L-selenomethionine complex, shall be
incorporated into each ton of complete feed by adding no less than 1
pound of a premix containing no more than 272.4 milligrams of added
selenium per pound.
(4) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act, the
label and labeling of zinc-L-selenomethionine complex in its packaged
form shall contain:
(i) The name of the additive, zinc-L-selenomethionine complex;
(ii) Minimum and maximum guarantees for total selenium;
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(iii) Minimum guarantee for selenomethionine content;
(iv) The following statement, ``Storage Conditions: zinc-L-
selenomethionine complex must be stored in a closed package at
temperature not higher than 25 [deg]C (77 [deg]F).''; and
(v) An expiration date not to exceed 6 months from the date of
manufacture.
(5) Usage of this additive must conform to the requirements of
paragraphs (d) and (e) of this section.
Dated: May 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08864 Filed 5-16-25; 8:45 am]
BILLING CODE 4164-01-P
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