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###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 573
          - [Docket No. FDA-2023-F-5500]

# 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 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,                         *wasima.wahid@fda.hhs.gov.*

# 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                           ( print 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 § 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 § 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

1. The authority citation for part 573 continues to read as follows: 

Authority:21 U.S.C. 321, 342, 348.

2. In § 573.304, revise the section heading and paragraphs (b)(1), (d)(3)(i), and (e)(2)(ii)(A) to read as follows: 

§ 573.304 

* * * * *

(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