Final Rule; Response to Objections and Denial of Public Hearing Requests; Removal of Administrative Stay

The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food Safety on the final rule entitled "Listing of Color Additives Exempt from Certification; Soy Leghemoglobin", published on 1 August 2019. The final rule amended the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. After reviewing the objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. We are also providing notice that the administrative stay of the effective date for this color additive regulation is now lifted.

The final rule published in the Federal Register of 1 August 2019 (84 FR 37573) with an effective date of 4 September 2019, was administratively stayed by the filing of objections under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)(2)) as of 3 September 2019. FDA lifts the administrative stay as of 19 December 2019.