Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)

• Published date: 11 May 2020
• Citation: 85 FR 27692
• Record Number: 2020-09186
• Section: Proposed rules
• Court: Food And Drug Administration

Federal Register, Volume 85 Issue 91 (Monday, May 11, 2020)

[Federal Register Volume 85, Number 91 (Monday, May 11, 2020)]
                [Proposed Rules]
                [Pages 27692-27693]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-09186]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                21 CFR Part 573
                [Docket No. FDA-2020-F-1289]
                Adisseo France S.A.S.; 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 Adisseo France S.A.S. has filed a petition proposing that the food
                additive regulations be amended to provide for the safe use of
                selenomethionine hydroxy analogue as a source of selenium in feed for
                beef and dairy cattle.
                DATES: The food additive petition was filed on March 27, 2020.
                ADDRESSES: For access to the docket, 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: Chelsea Cerrito, Center for Veterinary
                Medicine, Food and Drug Administration,7519 Standish Pl., Rockville, MD
                20855, 240-402-6729, [email protected].
                SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
                Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a
                food additive petition (FAP 2312) has been filed by Adisseo France
                S.A.S.; Immeuble Antony Parc II, 10 Place du G[eacute]n[eacute]ral de
                Gaulle, 92160 Antony, France. 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 selenomethionine hydroxy analogue as a
                source of selenium in feed for beef and dairy cattle.
                 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
                [[Page 27693]]
                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. 2020-09186 Filed 5-8-20; 8:45 am]
                 BILLING CODE 4164-01-P