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 § 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.

89 FR 104908