SUPPLEMENTARY INFORMATION:

Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 4C0326), submitted by Phytolon Ltd., Ha-Tsmikha St, Yokne'am Illit, Israel. The petition proposes to amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt From Certification,” to provide for the safe use of beetroot red for the coloring of foods generally in amounts consistent with current good manufacturing practice.

The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r), which applies to an action for substances which occur naturally in the environment, and for which the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment. 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.

89 FR 17789