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

 
CONTENT
Federal Register, Volume 85 Issue 88 (Wednesday, May 6, 2020)
[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, [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 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