AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of petition.

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 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.