2024-30362: Monterey Mushrooms, LLC; Filing of Food Additive Petition

Federal Register, Volume 89 Issue 247 (Thursday, December 26, 2024) [Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)] [Proposed Rules] [Pages 104908-104909] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-30362] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2024-F-5640] Monterey Mushrooms, LLC; 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 Monterey Mushrooms, LLC, proposing that the food additive regulations for vitamin D2 mushroom powder be amended to provide for an additional method for producing the additive.

Dates

The food additive petition was filed on December 11, 2024.

Addresses

For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the [[Page 104909]] 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

Katie Overbey, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-7536.

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 5M4841), submitted by Monterey Mushrooms, LLC, 260 Westgate Dr., Watsonville, CA 95076. The petition proposes to amend the food additive regulations in Sec. 172.382 (21 CFR 172.382 Vitamin D2 mushroom powder) to provide for production of the additive by exposing sliced or diced edible cultivars of Agaricus bisporus to ultraviolet light. The petitioner has claimed that this action is categorically excluded from the requirement to prepare an environmental assessment or an environmental impact statement under 21 CFR 25.32(k) because the substance is intended to remain in food through ingestion by consumers and is not intended to replace macronutrients in food. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. 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 13, 2024.