2024-29248: Leprino Nutrition; Filing of Food Additive Petition

Federal Register, Volume 89 Issue 239 (Thursday, December 12, 2024) [Federal Register Volume 89, Number 239 (Thursday, December 12, 2024)] [Proposed Rules] [Page 100404] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-29248] ======================================================================== Proposed Rules Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. ======================================================================== Federal Register / Vol. 89, No. 239 / Thursday, December 12, 2024 / Proposed Rules [[Page 100404]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. FDA-2024-F-5467] Leprino Nutrition; Filing of Food Additive Petition

Agency

Food and Drug Administration, HHS.

Action

Notification of petition. -----------------------------------------------------------------------

Summary

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Leprino Nutrition, proposing that the food additive regulations be amended to provide for the safe use of ultraviolet light for the reduction of microorganisms in whey products.

Dates

The food additive petition was filed on November 22, 2024.

Addresses

For access to the docket to read background documents or 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.

For Further Information Contact

Lane A. Highbarger, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1204.

Supplementary Information

Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 5M4840), submitted on behalf of Leprino Nutrition by Keller and Heckman LLP, 1001 G St. NW, Suite 500 West, Washington, DC 20001. The petition proposes to amend the food additive regulations in Sec. 179.39 (21 CFR 179.39), ``Ultraviolet radiation for the processing and treatment of food,'' to provide for the safe use of ultraviolet light for the reduction of microorganisms in whey products. The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(j), which applies to an action for substances used as a component of a food-contact surface of permanent or semipermanent equipment or of another food-contact article intended for repeated use. In addition, the petitioner has stated that, to its knowledge, no extraordinary circumstances exist that would warrant an environmental assessment (see 21 CFR 25.21). If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection. Dated: December 4, 2024.