[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 [www.gpo.gov]
[FR Doc No: 2022-07680]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 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:
     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-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 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 objections 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: Megan Hall, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-221), 
Rockville, MD 20855, 301-796-3801, [email protected].

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