83_FR_54736 83 FR 54526 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use)

83 FR 54526 - Zinpro Corp.; Filing of Food Additive Petition (Animal Use)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 210 (October 30, 2018)

Page Range54526-54526
FR Document2018-23672

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.

Federal Register, Volume 83 Issue 210 (Tuesday, October 30, 2018)
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Proposed Rules]
[Page 54526]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23672]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / 
Proposed Rules

[[Page 54526]]



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.

ACTION: Notification; petition for rulemaking.

-----------------------------------------------------------------------

SUMMARY: 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 Drinking Water of 
Animals to provide for the safe use of silicon dioxide as an anticaking 
agent for the use with zinc-L-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



                                                54526

                                                Proposed Rules                                                                                                Federal Register
                                                                                                                                                              Vol. 83, No. 210

                                                                                                                                                              Tuesday, October 30, 2018



                                                This section of the FEDERAL REGISTER                    Drinking Water of Animals to provide                  ADDRESSES:   For access to the docket, go
                                                contains notices to the public of the proposed          for the safe use of silicon dioxide as an             to https://www.regulations.gov and
                                                issuance of rules and regulations. The                  anticaking agent for the use with zinc-               insert the docket number, found in
                                                purpose of these notices is to give interested          L-selenomethionine as a feed
                                                persons an opportunity to participate in the
                                                                                                                                                              brackets in the heading of this
                                                rule making prior to the adoption of the final
                                                                                                        component. In an earlier notice of                    document, into the ‘‘Search’’ box and
                                                rules.                                                  petition (79 FR 49465, August 21, 2014),              follow the prompts; and/or go to the
                                                                                                        the use of silicon dioxide was omitted.               Dockets Management Staff, 5630 Fishers
                                                                                                          The petitioner has claimed that this                Lane, Rm. 1061, Rockville, MD 20852.
                                                DEPARTMENT OF HEALTH AND                                action is categorically excluded under
                                                HUMAN SERVICES                                          21 CFR 25.32(r) because it is of a type               FOR FURTHER INFORMATION CONTACT:
                                                                                                        that does not individually or                         Chelsea Trull, Center for Veterinary
                                                Food and Drug Administration                            cumulatively have a significant effect on             Medicine, Food and Drug
                                                                                                        the human environment. In addition,                   Administration, 7519 Standish Pl.,
                                                21 CFR Part 573                                         the petitioner has stated that, to their              Rockville, MD 20855, 240–402–6729,
                                                                                                        knowledge, no extraordinary                           Chelsea.Trull@fda.hhs.gov.
                                                [Docket No. FDA–2014–F–1184]
                                                                                                        circumstances exist. If FDA determines                SUPPLEMENTARY INFORMATION:      Under the
                                                Zinpro Corp.; Filing of Food Additive                   a categorical exclusion applies, neither
                                                                                                                                                              Federal Food, Drug, and Cosmetic Act
                                                Petition (Animal Use)                                   an environmental assessment nor an
                                                                                                                                                              (section 409(b)(5) (21 U.S.C. 348(b)(5))),
                                                                                                        environmental impact statement is
                                                AGENCY:    Food and Drug Administration,                                                                      notice is given that a food additive
                                                                                                        required. If FDA determines a
                                                HHS.                                                    categorical exclusion does not apply, we              petition (FAP 2291) has been filed by
                                                ACTION:Notification; petition for                       will request an environmental                         Adisseo France S.A.S., Immeuble
                                                rulemaking.                                             assessment and make it available for                  Antony Parc II, 10 Place du Général de
                                                                                                        public inspection.                                    Gaulle, 92160 Antony, France. The
                                                SUMMARY:   The Food and Drug                                                                                  petition proposes to amend Title 21 of
                                                                                                          Dated: October 25, 2018.                            the Code of Federal Regulations (CFR)
                                                Administration (FDA or we) is
                                                announcing that Zinpro Corp. has filed                  Leslie Kux,                                           in part 573 (21 CFR part 573) Food
                                                a petition proposing that the food                      Associate Commissioner for Policy.                    Additives Permitted in Feed and
                                                additive regulations be amended to                      [FR Doc. 2018–23672 Filed 10–29–18; 8:45 am]          Drinking Water of Animals to provide
                                                provide for the safe use of silicon                     BILLING CODE 4164–01–P                                for the safe use of silicon dioxide as a
                                                dioxide as an anticaking agent for the                                                                        carrier for selenomethionine hydroxy
                                                use with zinc-L-selenomethionine as a                                                                         analogue at a level not to exceed 95
                                                feed component.                                         DEPARTMENT OF HEALTH AND                              percent of the selenomethionine
                                                                                                        HUMAN SERVICES                                        hydroxy analogue in its packaged form.
                                                DATES: The food additive petition was
                                                filed on July 29, 2014.                                 Food and Drug Administration                          In an earlier notice of petition (80 FR
                                                ADDRESSES: For access to the docket, go                                                                       48471, August 13, 2015), the use of
                                                to https://www.regulations.gov and                      21 CFR Part 573                                       silicon dioxide was omitted.
                                                insert the docket number, found in                                                                              The petitioner has claimed that this
                                                brackets in the heading of this                         [Docket No. FDA–2015–F–2712]
                                                                                                                                                              action is categorically excluded under
                                                document, into the ‘‘Search’’ box and                                                                         21 CFR 25.32(r) because it is of a type
                                                                                                        Adisseo France S.A.S.; Filing of Food
                                                follow the prompts; and/or go to the                                                                          that does not individually or
                                                                                                        Additive Petition (Animal Use)
                                                Dockets Management Staff, 5630 Fishers                                                                        cumulatively have a significant effect on
                                                Lane, Rm. 1061, Rockville, MD 20852.                    AGENCY:    Food and Drug Administration,              the human environment. In addition,
                                                FOR FURTHER INFORMATION CONTACT:                        HHS.                                                  the petitioner has stated that, to their
                                                Carissa Doody, Center for Veterinary                    ACTION:Notification; petition for                     knowledge, no extraordinary
                                                Medicine, Food and Drug                                 rulemaking.                                           circumstances exist. If FDA determines
                                                Administration, 7519 Standish Pl.,                                                                            a categorical exclusion applies, neither
                                                Rockville, MD 20855, 240–402–6283,                      SUMMARY:   The Food and Drug                          an environmental assessment nor an
                                                Carissa.doody@fda.hhs.gov.                              Administration (FDA or we) is                         environmental impact statement is
                                                SUPPLEMENTARY INFORMATION: Under the                    announcing that Adisseo France S.A.S.                 required. If FDA determines a
                                                Federal Food, Drug, and Cosmetic Act                    has filed a petition proposing that the               categorical exclusion does not apply, we
                                                (section 409(b)(5) (21 U.S.C. 348(b)(5))),              food additive regulations be amended to               will request an environmental
khammond on DSK30JT082PROD with PROPOSAL




                                                notice is given that a food additive                    provide for the safe use of silicon                   assessment and make it available for
                                                petition (FAP 2285) has been filed by                   dioxide as a carrier for                              public inspection.
                                                Zinpro Corp., 10400 Viking Dr., Suite                   selenomethionine hydroxy analogue at a
                                                                                                                                                                Dated: October 25, 2018.
                                                240, Eden Prairie, MN 55344. The                        level not to exceed 95 percent of the
                                                                                                        selenomethionine hydroxy analogue in                  Leslie Kux,
                                                petition proposes to amend Title 21 of
                                                the Code of Federal Regulations (CFR)                   its packaged form.                                    Associate Commissioner for Policy.
                                                in part 573 (21 CFR part 573) Food                      DATES: The food additive petition was                 [FR Doc. 2018–23671 Filed 10–29–18; 8:45 am]
                                                Additives Permitted in Feed and                         filed on June 18, 2015.                               BILLING CODE 4164–01–P




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Document Created: 2018-10-30 00:43:33
Document Modified: 2018-10-30 00:43:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification; petition for rulemaking.
DatesThe food additive petition was filed on July 29, 2014.
ContactCarissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, [email protected]
FR Citation83 FR 54526 

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