[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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