[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35806-35807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2021-F-0564]


Biomin Holding GmbH; Filing of Food Additive Petition (Animal 
Use)

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Biomin Holding GmbH, 
proposing that the food additive regulations be amended to provide for 
the safe use of fumonisin esterase to degrade fumonisins in poultry 
feed.

DATES: The food additive petition was filed on May 20, 2021.

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: Wasima Wahid, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-221), 
Rockville, MD 20855, 240-402-5857, [email protected].

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 2314), submitted by 
Biomin Holdings GmbH, Biomin Research Center, Technopark 1, 3430 Tulin, 
Austria. 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 fumonisin esterase to degrade fumonisins in poultry feed.
    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

[[Page 35807]]

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: June 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14465 Filed 7-6-21; 8:45 am]
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