[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.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30362 Filed 12-23-24; 8:45 am]
BILLING CODE 4164-01-P