[Federal Register Volume 85, Number 37 (Tuesday, February 25, 2020)]
[Proposed Rules]
[Pages 10632-10633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03728]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 2020-F-0268]
Unilever; 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 Unilever, proposing that
the food additive regulations be amended to provide for the safe use of
potassium iodate in salt added to select food categories as a source of
dietary iodine.
DATES: The food additive petition was filed on November 25, 2019.
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: Jason Downey, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-9241.
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 0A4824), submitted on
behalf of Unilever by Exponent, Inc., 1150 Connecticut Ave. NW, Suite
1100, Washington, DC 20036. 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 provide for the safe
use of potassium iodate added to salt in the following select food
categories: (1) Potato dumpling and pancake mixes, (2) matzo ball mix,
(3) falafel mix, (4) select spreads and salad dressings, (5) margarine
and margarine-like spreads, (6) tuna sandwich spread, (7) seasoned
noodles/rice dry mixes, and (8) dry
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soup, broth, bouillon, and stock, as a source of dietary iodine at a
maximum level of 40 milligrams potassium iodate per kilogram of salt
(sodium chloride).
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 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: February 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03728 Filed 2-24-20; 8:45 am]
BILLING CODE 4164-01-P