[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Proposed Rules]
[Pages 65717-65718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25904]


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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.

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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

[[Page 65718]]

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]
BILLING CODE 4164-01-P


