Leprino Nutrition; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 179</CFR> <DEPDOC>[Docket No. FDA-2024-F-5467]</DEPDOC> <SUBJECT>Leprino Nutrition; Filing of Food Additive Petition</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notification of petition. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> The food additive petition was filed on November 22, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Lane A. Highbarger, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1204. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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 § 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. <SIG> <DATED>Dated: December 4, 2024.</DATED> <NAME>P. Ritu Nalubola,</NAME> Associate Commissioner for Policy. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2024-29248 Filed 12-11-24; 8:45 am]</FRDOC>