Rule2022-07680
Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid
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
April 11, 2022
Effective
April 11, 2022
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 methyl esters of conjugated linoleic acid for early lactation dairy cows to reduce the energy concentration in milk. This action is in response to a food additive petition filed by BASF Corp.
Full Text
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<title>Federal Register, Volume 87 Issue 69 (Monday, April 11, 2022)</title>
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[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Rules and Regulations]
[Pages 21018-21019]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07680]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2011-F-0365]
Food Additives Permitted in Feed and Drinking Water of Animals;
Methyl Esters of Conjugated Linoleic Acid
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 methyl esters
of conjugated linoleic acid for early lactation dairy cows to reduce
the energy concentration in milk. This action is in response to a food
additive petition filed by BASF Corp.
DATES: This rule is effective April 11, 2022. See section V of this
document for further information on the filing of objections. Submit
either electronic or written objections and requests for a hearing on
the final rule by May 11, 2022.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before May
11, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will
accept objections until 11:59 p.m. Eastern Time at the end of May 11,
2022. Objections received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is 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-2011-F-0365 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Methyl Esters of Conjugated Linoleic Acid; Silicon
Dioxide.'' 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 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 objections 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, 7519 Standish Pl. (HFV-221),
Rockville, MD 20855, 301-796-3801, <a href="/cdn-cgi/l/email-protection#bbf6dedcdad595f3dad7d7fbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="bcf1d9dbddd292f4ddd0d0fcdad8dd92d4d4cf92dbd3ca">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of June 6, 2011 (76
FR 32332), FDA announced that we had filed a food additive petition
(animal use) (FAP 2269) submitted by BASF Corp., 100 Campus Dr.,
Florham Park, NJ 07932. The petition proposed that the regulations for
food additives permitted in feed and drinking water of
[[Page 21019]]
animals be amended to provide for the safe use of methyl esters of
conjugated linoleic acid as a source of fatty acids in lactating dairy
cow diets and for the use of silicon dioxide as a carrier for the
methyl esters of conjugated linoleic acid.
In 2020, 21 CFR 573.940 was amended to provide for the safe use of
silicon dioxide as an anticaking agent, grinding aid, antifoaming
agent, or carrier in animal feed components (ingredients, intermediate
premixes, premixes, supplements, or concentrates) across food
substances under FAP 2308 (85 FR 33539, June 2, 2020).
II. Conclusion
FDA concludes that the data establish the safety and utility of
methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-
10, cis-12 octadecadienoic acids) for early lactation dairy cows to
reduce the energy concentration in milk, 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
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
Any person who will be adversely affected by this regulation may
file with the Dockets Management Staff (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of 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. 573.637, revise the introductory text and paragraph (b) to
read as follows:
Sec. 573.637 Methyl esters of conjugated linoleic acid (cis-9,
trans-11 and trans-10, cis-12-octadecadienoic acids).
The food additive, methyl esters of conjugated linoleic acid (cis-
9, trans-11 and trans-10, cis-12-octadecadienoic acids) may be safely
used in swine feed and feed for early lactation dairy cows (less than
100 days in milk) in accordance with the prescribed conditions:
* * * * *
(b) The additive is used or intended for use in the feed of:
(1) Growing and finishing swine as a source of fatty acids at
levels not to exceed 0.6% in the finished feed.
(2) Early lactation dairy cows to reduce the energy concentration
in milk when fed at levels not to exceed 33 grams per cow per day.
* * * * *
Dated: April 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07680 Filed 4-8-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 11, 2022.
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