[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Proposed Rules]
[Pages 47118-47119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20217]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2018-F-3230]


Oakshire Naturals LP; 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 Oakshire Naturals LP, 
proposing that the food additive regulations be amended to provide for 
the safe use of vitamin D2 mushroom powder as a nutrient 
supplement in specific food categories.

DATES: The food additive petition was filed on July 16, 2018.

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: Judith Kidwell, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1071.

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 8A4821), submitted by 
Oakshire Naturals LP, 295 Thompson Road, P.O. Box 388, Kennett Square, 
PA 19348. The petition proposes to amend the food additive regulations 
in part 172 (21 CFR part 172) Food Additives Permitted for Direct 
Addition to Food for Human Consumption to provide for the safe use of 
vitamin D2 mushroom powder, produced by exposing homogenized 
edible mushrooms to ultraviolet light, as a nutrient supplement in: (1) 
Foods to which vitamin D2, vitamin D3, and 
vitamin D2 bakers yeast are currently allowed to be added 
under 21 CFR 184.1950, 172.379, 172.380, and 172.381 (excluding cheese 
and cheese products, foods represented for use as a sole source of 
nutrition for enteral feeding, infant formula, milk and milk products, 
and margarine); (2) fruit smoothies; (3) vegetable juices; (4) extruded 
vegetable snacks; (5) soups and soup mixes (except for those containing 
meat or poultry that are subject to regulation by the U.S. Department 
of Agriculture under the Federal Meat Inspection Act or the Poultry 
Products Inspection Act); and (6) plant protein products as defined in 
21 CFR 170.3(n)(33).
    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. If

[[Page 47119]]

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 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20217 Filed 9-17-18; 8:45 am]
 BILLING CODE 4164-01-P


