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Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal Use)

---
identifier: "/us/fr/2019-25904"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal Use)"
title_number: 0
title_name: "Federal Register"
section_number: "2019-25904"
section_name: "Alzchem Trostberg GmbH; Filing of Food Additive Petition (Animal Use)"
positive_law: false
currency: "2019-11-29"
last_updated: "2019-11-29"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2019-25904"
document_type: "proposed_rule"
publication_date: "2019-11-29"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 573"
fr_citation: "84 FR 65717"
fr_volume: 84
docket_ids:
  - "Docket No. FDA-2019-F-5401"
fr_action: "Notification; petition for rulemaking."
---

#  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, *[email protected]* .

**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.