[Federal Register Volume 85, Number 88 (Wednesday, May 6, 2020)]
[Proposed Rules]
[Page 26902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2020-F-1275]


Biomin 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 we have filed a petition, submitted by Biomin GmbH, proposing that 
the food additive regulations be amended to provide for the safe use of 
fumonisin esterase to degrade fumonisins present in swine feed.

DATES: The food additive petition was filed on March 26, 2020.

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: 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))), we are giving notice 
that we have filed a food additive petition (FAP 2311) submitted by 
Biomin GmbH; Erber Campus 1, 3131 Getzersdorf, 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 present in swine 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 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: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09187 Filed 5-5-20; 8:45 am]
 BILLING CODE 4164-01-P


