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

• Published date: 06 May 2020
• Citation: 85 FR 26902
• Record Number: 2020-09187
• Section: Proposed rules
• Court: Food And Drug Administration

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