Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use), 54526 [2018-23671]

Download as PDF 54526 Proposed Rules Federal Register Vol. 83, No. 210 Tuesday, October 30, 2018 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2014–F–1184] Zinpro Corp.; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. Notification; petition for rulemaking. ACTION: The Food and Drug Administration (FDA or we) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as an anticaking agent for the use with zinc-L-selenomethionine as a feed component. DATES: The food additive petition was filed on July 29, 2014. 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: Carissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6283, Carissa.doody@fda.hhs.gov. 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 2285) has been filed by Zinpro Corp., 10400 Viking Dr., Suite 240, Eden Prairie, MN 55344. 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 khammond on DSK30JT082PROD with PROPOSAL SUMMARY: VerDate Sep<11>2014 17:16 Oct 29, 2018 Jkt 247001 Drinking Water of Animals to provide for the safe use of silicon dioxide as an anticaking agent for the use with zincL-selenomethionine as a feed component. In an earlier notice of petition (79 FR 49465, August 21, 2014), the use of silicon dioxide was omitted. 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: October 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23672 Filed 10–29–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2015–F–2712] Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. Notification; petition for rulemaking. ACTION: 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 silicon dioxide as a carrier for selenomethionine hydroxy analogue at a level not to exceed 95 percent of the selenomethionine hydroxy analogue in its packaged form. DATES: The food additive petition was filed on June 18, 2015. SUMMARY: PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6729, Chelsea.Trull@fda.hhs.gov. 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 2291) has been filed by Adisseo France S.A.S., Immeuble Antony Parc II, 10 Place du Ge´ne´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 silicon dioxide as a carrier for selenomethionine hydroxy analogue at a level not to exceed 95 percent of the selenomethionine hydroxy analogue in its packaged form. In an earlier notice of petition (80 FR 48471, August 13, 2015), the use of silicon dioxide was omitted. SUPPLEMENTARY INFORMATION: 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: October 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23671 Filed 10–29–18; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\30OCP1.SGM 30OCP1

Agencies

[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Proposed Rules]
[Page 54526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2712]


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 silicon 
dioxide as a carrier for selenomethionine hydroxy analogue at a level 
not to exceed 95 percent of the selenomethionine hydroxy analogue in 
its packaged form.

DATES: The food additive petition was filed on June 18, 2015.

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 Trull, 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 2291) 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 silicon dioxide as a carrier for 
selenomethionine hydroxy analogue at a level not to exceed 95 percent 
of the selenomethionine hydroxy analogue in its packaged form. In an 
earlier notice of petition (80 FR 48471, August 13, 2015), the use of 
silicon dioxide was omitted.
    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: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23671 Filed 10-29-18; 8:45 am]
 BILLING CODE 4164-01-P