Proposed Rules. Notification of petition

Agency: Food and Drug Administration, HHS
Action: Notification of petition
Citation: FR Doc. 2024-09027 · Docket No. FDA-2024-F-1912 · 21 CFR 177

Summary

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene.

Dates

The food additive petition was filed on April 17, 2024. Either electronic or written comments must be submitted by June 25, 2024.

Supplementary Information

I. Background Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 3B4837), submitted by Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini, c/o Maricel Maffini, Frederick, MD 21701. The petition proposes that we revoke § 177.1615 (21 CFR 177.1615, “Polyethylene, fluorinated”). II. Request To Repeal 21 CFR Part 177.1615 In accordance with the procedures for amending or repealing a food additive regulation in § 171.130 (21 CFR 171.130), the petition asks us to repeal § 177.1615. Specifically, the petitioners state that the fluorinated polyethylene manufactured consistent with § 177.1615 can produce polymeric per- and poly-fluorinated alkyl substances that can migrate to food and, therefore, are not safe pursuant to section 409(c)(5) of the FD&C Act (21 U.S.C. 348(c)(5)). The petition is available in the docket. We invite comments, additional scientific data, and other information related to the issues raised by this petition. If we determine that the available data justifies repealing § 177.1615, we will publish our decision in the Federal Register in accordance with § 171.130. The petitioners have claimed that this action is categorically excluded under 21 CFR 25.32(m), which applies to an action to prohibit or otherwise restrict or reduce the use of a substance in food, food packaging, or cosmetics. In addition, the petitioners have 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: April 23, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-09027 Filed 4-25-24; 8:45 am]