2024-12533. Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose

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 ethyl cellulose as a matrix scaffolding for tracers, and the ethyl cellulose shall not exceed 80 percent of the tracer. This action is in response to a food additive petition filed by Micro-Tracers, Inc.

DATES:

This rule is effective June 7, 2024. 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 rule must be submitted by July 8, 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 July 8, 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-0147 for “Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose.” 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 onhttps://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:

Megan Hall, Center for Veterinary Medicine (HFV-221), Food and Drug Administration, 12225 Wilkins Ave., Rockville, MD 20852, 240-796-3801, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In a document published in the Federal Register of February 6, 2023 (88 FR 7657), FDA announced that we had filed a food additive petition (animal use) (FAP 2316) submitted by Micro Tracers, Inc., 1375 Van Dyke Ave., San Francisco, CA 94124. 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 ethyl cellulose as a matrix scaffolding in tracers for use in feeds at no more than 0.09 grams per ton of feed (0.1 ppm).

II. Conclusion

Pursuant to the review of the petition, the intended use rate of the ethyl cellulose in tracers is now characterized as a percentage of the tracer, not as ppm in complete feed. The use of the food additive, ethyl cellulose, as a component of the tracer is a more accurate characterization of the food additive than as proposed in the petition (the food additive as a component of complete feed). Therefore, the intended use rate of the food additive has been recharacterized as a percentage of the tracer. The ethyl cellulose is intended to be used as a matrix scaffolding in tracers, with the ethyl cellulose content not exceeding 80 percent of the tracer.

FDA concludes that the data establish the safety and utility of ethyl cellulose as a matrix scaffolding in tracers, with the ethyl cellulose content not exceeding 80 percent of the tracer 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

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

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

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

2. In § 573.420, revise paragraph (b) to read as follows:

§ 573.420

Ethyl cellulose.

* * * * *

(b) It is used or intended for use:

(1) As a binder or filler in dry vitamin preparations to be incorporated into animal feed.

(2) As a matrix scaffolding for tracers, and the ethyl cellulose content shall not exceed 80 percent of the tracer.

Dated: June 3, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.