Document ID: FDA-2021-F-1157-0001
Agency: fda
Document Type: Proposed Rule
Title: Lallemand Inc.; Filing of Food Additive
Petition
Posted Date: 2021-12-29T05:00Z

[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Proposed Rules]
[Page 74018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28162]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2021-F-1157]

Lallemand Inc.; 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 Lallemand Inc., proposing 
that the food additive regulations be amended to provide for the safe 
use of vitamin D2 heat-killed (``inactive'') baker's yeast 
as a source of vitamin D2 in specific food categories.

DATES: The food additive petition was filed on September 28, 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 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 1A4829), submitted by 
Lallemand Inc., 1620 rue Prefontaine, Montreal, Quebec, H1W 2N8, 
Canada. The petition proposes to amend the food additive regulations in 
21 CFR part 172, Food additives permitted for direct addition to food 
for human consumption, to allow for the safe use of vitamin 
D2 heat-killed bakers yeast as a nutrient supplement in 
foods to which vitamin D2 mushroom powder is currently 
allowed to be added under Sec.  172.382 (21 CFR 172.382), at the 
maximum level of vitamin D2 authorized under Sec.  172.382.
    The petitioner has claimed a categorical exclusion 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: December 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28162 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P