Notices. Notification; petition for rulemaking
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/register/2019/11/29/2019-25904·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2019-F-5401] Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. ACTION: Notification; petition for rulemaking. SUMMARY: The Food and Drug Administration (FDA or we) is announcing that Alzchem Trostberg GmbH has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds.
DATES: The food additive petition was filed on September 25, 2019. ADDRESSES: For access to the docket, 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: Carissa Adams, Center for Veterinary Medicine, Food and Drug Administration,7519 Standish Pl., Rockville, MD 20855, 240-402-6283, *Carissa.Adams@fda.hhs.gov* .
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2309) has been filed by Alzchem Trostberg GmbH, CHEMIEPARK TROSTBERG, Dr.-Albert-Frank-Str. 32, 83308 Trostberg, Germany. The petition proposes to amend Title 21 of the Code of Federal Regulations
(CFR)in part 573 (21 CFR part 573) *Food Additives Permitted in Feed and Drinking Water of Animals* to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds. 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. 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: November 25, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-25904 Filed 11-27-19; 8:45 am]
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