
[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Proposed Rules]
[Page 70919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2003-F-0321]


Kerry 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 Kerry, Inc., proposing that 
the food additive regulations be amended to provide for the safe use of 
sodium alginate as a stabilizer and thickener in plant protein products 
at a level not to exceed 3 percent.

DATES: The food additive petition was filed on August 9, 2023.

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: Christopher Kampmeyer, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1255.

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 3A4836), submitted on 
behalf of Kerry Inc., by ToxStrategies, LLC, 739 Thornapple Dr., 
Naperville, IL 60540. 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 sodium alginate as a stabilizer and thickener in plant 
protein products (as defined in 21 CFR 170.3(n)(33)) at a level not to 
exceed 3 percent.
    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 that 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: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22637 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P


