[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Proposed Rules]
[Page 50496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2021-F-0926]


Monaghan Mushrooms Ireland Unlimited Company; Filing of Food 
Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Monaghan Mushrooms Ireland 
Unlimited Company, proposing that the food additive regulations be 
amended to provide for the safe use of vitamin D2 mushroom 
powder produced by exposing dried and powdered edible cultivars of 
Agaricus bisporus to ultraviolet light.

DATES: The food additive petition was filed on June 8, 2021.

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: Katie Overbey, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-7536.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), we are giving notice that 
we have filed a food additive petition (FAP 1A4828), submitted by 
Monaghan Mushrooms Ireland Unlimited Company, Tullygony, Tyholland, 
County Monaghan, H18 FW95, Ireland. The petition proposes to amend the 
food additive regulations in Sec.  172.382 (21 CFR 172.382) Vitamin D2 
mushroom powder to provide for the safe use of vitamin D2 
mushroom powder produced by exposing dried and powdered edible 
cultivars of Agaricus bisporus to ultraviolet light.
    The petitioner has claimed that this action is categorically 
excluded 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 that 
would warrant at least 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: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19409 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P


