82_FR_34757 82 FR 34615 - Juice Products Association; Filing of Food Additive Petition

82 FR 34615 - Juice Products Association; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 142 (July 26, 2017)

Page Range34615-34615
FR Document2017-15535

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D<INF>3</INF> with absolute values and to update the specifications for vitamin D<INF>3</INF>.

Federal Register, Volume 82 Issue 142 (Wednesday, July 26, 2017)
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Proposed Rules]
[Page 34615]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15535]


========================================================================
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. 82, No. 142 / Wednesday, July 26, 2017 / 
Proposed Rules

[[Page 34615]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2017-F-3717]


Juice Products Association; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by the Juice Products 
Association, proposing that the food additive regulations be amended to 
replace the current Recommended Daily Intake (RDI) percentage values of 
calcium in fruit juices and fruit juice drinks in the regulation for 
vitamin D3 with absolute values and to update the 
specifications for vitamin D3.

DATES: The food additive petition was filed on June 1, 2017.

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: Judith Kidwell, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1071.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that 
we have filed a food additive petition (FAP 7A4818), submitted on 
behalf of the Juice Products Association by Hogan Lovells US LLP, 
Columbia Square, 555 Thirteenth Street NW., Washington, DC 20004. The 
petition proposes to amend the food additive regulations in Sec.  
172.380 (21 CFR 172.380) Vitamin D3 by replacing the current 
RDI percentage values of calcium in fruit juices and fruit juice drinks 
specified in Sec.  172.380(c)(1) and (2) with absolute values and to 
update the specifications for vitamin D3 established in 
Sec.  172.380(b) by incorporating by reference the most recent edition 
of the Food Chemicals Codex.
    These proposed changes would allow manufacturers of fruit juices 
and fruit juice drinks that are fortified with calcium to maintain the 
absolute level of added calcium at 330 milligrams (mg) and 130 mg, 
respectively, as established in our regulations at Sec.  172.380(c)(1) 
and (2).
    We have determined under 21 CFR 25.30(i) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment because the amendments are 
administrative in nature and permit manufacturers of fruit juices and 
fruit juice drinks that are fortified with calcium to maintain current 
calcium fortification levels in these products. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

    Dated: July 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15535 Filed 7-25-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                                                                                                                                  34615

                                                 Proposed Rules                                                                                                 Federal Register
                                                                                                                                                                Vol. 82, No. 142

                                                                                                                                                                Wednesday, July 26, 2017



                                                 This section of the FEDERAL REGISTER                     § 172.380 (21 CFR 172.380) Vitamin D3                 source of selenium in complete feed for
                                                 contains notices to the public of the proposed           by replacing the current RDI percentage               laying hens and for the safe use of the
                                                 issuance of rules and regulations. The                   values of calcium in fruit juices and                 approved food additive silicon dioxide
                                                 purpose of these notices is to give interested           fruit juice drinks specified in                       as an anticaking agent for use with zinc-
                                                 persons an opportunity to participate in the             § 172.380(c)(1) and (2) with absolute
                                                 rule making prior to the adoption of the final                                                                 L-selenomethionine as a feed
                                                 rules.
                                                                                                          values and to update the specifications               component.
                                                                                                          for vitamin D3 established in
                                                                                                          § 172.380(b) by incorporating by                      DATES:  The food additive petition was
                                                 DEPARTMENT OF HEALTH AND                                 reference the most recent edition of the              filed on June 1, 2017.
                                                 HUMAN SERVICES                                           Food Chemicals Codex.                                 ADDRESSES:   For access to the docket, go
                                                                                                            These proposed changes would allow
                                                                                                                                                                to https://www.regulations.gov and
                                                 Food and Drug Administration                             manufacturers of fruit juices and fruit
                                                                                                                                                                insert the docket number, found in
                                                                                                          juice drinks that are fortified with
                                                                                                                                                                brackets in the heading of this
                                                 21 CFR Part 172                                          calcium to maintain the absolute level
                                                                                                                                                                document, into the ‘‘Search’’ box and
                                                 [Docket No. FDA–2017–F–3717]
                                                                                                          of added calcium at 330 milligrams (mg)
                                                                                                          and 130 mg, respectively, as established              follow the prompts; and/or go to the
                                                                                                          in our regulations at § 172.380(c)(1) and             Dockets Management Staff, 5630 Fishers
                                                 Juice Products Association; Filing of                                                                          Lane, Rm. 1061, Rockville, MD 20852.
                                                 Food Additive Petition                                   (2).
                                                                                                            We have determined under 21 CFR                     FOR FURTHER INFORMATION CONTACT:
                                                 AGENCY:    Food and Drug Administration,                 25.30(i) that this action is of a type that           Chelsea Trull, Center for Veterinary
                                                 HHS.                                                     does not individually or cumulatively                 Medicine, Food and Drug
                                                 ACTION:Notification; petition for                        have a significant effect on the human                Administration, 7519 Standish Pl.,
                                                 rulemaking.                                              environment because the amendments                    Rockville, MD 20855, 240–402–6729,
                                                                                                          are administrative in nature and permit               chelsea.trull@fda.hhs.gov.
                                                 SUMMARY:   The Food and Drug
                                                                                                          manufacturers of fruit juices and fruit
                                                 Administration (FDA or we) is                                                                                  SUPPLEMENTARY INFORMATION:      Under the
                                                                                                          juice drinks that are fortified with
                                                 announcing that we have filed a                                                                                Federal Food, Drug, and Cosmetic Act
                                                                                                          calcium to maintain current calcium
                                                 petition, submitted by the Juice                                                                               (section 409(b)(5) (21 U.S.C. 348(b)(5))),
                                                                                                          fortification levels in these products.
                                                 Products Association, proposing that the                                                                       notice is given that a food additive
                                                                                                          Therefore, neither an environmental
                                                 food additive regulations be amended to                                                                        petition (FAP 2303) has been filed by
                                                                                                          assessment nor an environmental
                                                 replace the current Recommended Daily                                                                          Zinpro Corp., 10400 Viking Dr., Suite
                                                                                                          impact statement is required.
                                                 Intake (RDI) percentage values of
                                                                                                            Dated: July 19, 2017.                               240, Eden Prairie, MN 55344. The
                                                 calcium in fruit juices and fruit juice
                                                                                                          Anna K. Abram,                                        petition proposes to amend Title 21 of
                                                 drinks in the regulation for vitamin D3
                                                                                                                                                                the Code of Federal Regulations (CFR)
                                                 with absolute values and to update the                   Deputy Commissioner for Policy, Planning,
                                                 specifications for vitamin D3.                           Legislation, and Analysis.                            in part 573 (21 CFR part 573) Food
                                                                                                                                                                Additives Permitted in Feed and
                                                 DATES: The food additive petition was                    [FR Doc. 2017–15535 Filed 7–25–17; 8:45 am]
                                                                                                                                                                Drinking Water of Animals to provide
                                                 filed on June 1, 2017.                                   BILLING CODE 4164–01–P
                                                                                                                                                                for the safe use of zinc-L-
                                                 ADDRESSES: For access to the docket, go
                                                                                                                                                                selenomethionine as a nutritional
                                                 to https://www.regulations.gov and
                                                                                                          DEPARTMENT OF HEALTH AND                              source of selenium in complete feed for
                                                 insert the docket number, found in
                                                                                                          HUMAN SERVICES                                        laying hens and for the safe use of
                                                 brackets in the heading of this
                                                                                                                                                                silicon dioxide (21 CFR 573.940) as an
                                                 document, into the ‘‘Search’’ box and
                                                                                                          Food and Drug Administration                          anticaking agent for use with zinc-L-
                                                 follow the prompts; and/or go to the
                                                 Dockets Management Staff, 5630 Fishers                                                                         selenomethionine as a feed component.
                                                                                                          21 CFR Part 573                                          The petitioner has claimed that this
                                                 Lane, Rm. 1061, Rockville, MD 20852.
                                                 FOR FURTHER INFORMATION CONTACT:                         [Docket No. FDA–2017–F–4125]                          action is categorically excluded under
                                                 Judith Kidwell, Center for Food Safety                                                                         21 CFR 25.32(r) because it is of a type
                                                 and Applied Nutrition, Food and Drug                     Zinpro Corp.; Filing of Food Additive                 that does not individually or
                                                 Administration, 5001 Campus Dr.,                         Petition (Animal Use)                                 cumulatively have a significant effect on
                                                 College Park, MD 20740, 240–402–1071.                    AGENCY:    Food and Drug Administration,              the human environment. In addition,
                                                 SUPPLEMENTARY INFORMATION: Under                         HHS.                                                  the petitioner has stated that, to their
                                                 section 409(b)(5) of the Federal Food,                                                                         knowledge, no extraordinary
                                                                                                          ACTION:Notification; petition for
                                                                                                                                                                circumstances exist. If FDA determines
pmangrum on DSKBC4BHB2PROD with PROPOSALS




                                                 Drug, and Cosmetic Act (21 U.S.C.                        rulemaking.
                                                 348(b)(5)), we are giving notice that we                                                                       a categorical exclusion applies, neither
                                                 have filed a food additive petition (FAP                 SUMMARY:   The Food and Drug                          an environmental assessment nor an
                                                 7A4818), submitted on behalf of the                      Administration (FDA or we) is                         environmental impact statement is
                                                 Juice Products Association by Hogan                      announcing that Zinpro Corp. has filed                required. If FDA determines a
                                                 Lovells US LLP, Columbia Square, 555                     a petition proposing that the food                    categorical exclusion does not apply, we
                                                 Thirteenth Street NW., Washington, DC                    additive regulations be amended to                    will request an environmental
                                                 20004. The petition proposes to amend                    provide for the safe use of zinc-L-                   assessment and make it available for
                                                 the food additive regulations in                         selenomethionine as a nutritional                     public inspection.


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Document Created: 2017-07-26 01:30:04
Document Modified: 2017-07-26 01:30:04
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 June 1, 2017.
ContactJudith Kidwell, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1071.
FR Citation82 FR 34615 

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