Proposed Rules. Notification of petition
387 words·~2 min read·
/register/2025/08/19/2025-15792A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2025-F-3070] Evonik Corporation; Filing of Food Additive Petition (Animal Use) 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 food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of *Bacillus velezensis* as a source of viable microorganism in animal food for all species.
DATES: The food additive petition was filed on July 18, 2025. 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: Megan Hall, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, 301-796-3801, *Megan.Hall@fda.hhs.gov.* SUPPLEMENTARY INFORMATION:
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 2321), submitted by Evonik Corporation, 1701 Barrett Lakes Blvd. NW, Suite 340, Kennesaw, GA 30144. The petition proposes that we amend our food additive regulations in 21 CFR part 573—Food Additives Permitted in Feed and Drinking Water of Animals, to provide for the safe use of *Bacillus velezensis* as a source of viable microorganism in animal food for all species.
The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r) because it is of a type that does not individually or cumulatively have a significant effect on the human environment. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist that may significantly affect the quality of the human environment. 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: August 14, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-15792 Filed 8-18-25; 8:45 am]
Connectionstraces to 2
Traces to 2 documents
1 reference not yet in our index
- 21 CFR 573
Citation graph
cites case law
Cites 3Cited by 0 across 0 sources