82_FR_44726 82 FR 44542 - Idemitsu Kosan, Cp. Ltd.; Filing of Food Additive Petition (Animal Use)

82 FR 44542 - Idemitsu Kosan, Cp. Ltd.; Filing of Food Additive Petition (Animal Use)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 184 (September 25, 2017)

Page Range44542-44543
FR Document2017-20385

The Food and Drug Administration (FDA or we) is announcing that Idemitsu Kosan, Cp. Ltd. 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 flavors for use in animal feed.

Federal Register, Volume 82 Issue 184 (Monday, September 25, 2017)
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Proposed Rules]
[Pages 44542-44543]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20385]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-5528]


Idemitsu Kosan, Cp. Ltd.; Filing of Food Additive Petition 
(Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking.

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

[[Page 44543]]

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that Idemitsu Kosan, Cp. Ltd. 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 flavors for use in animal feed.

DATES: The food additive petition was filed on August 7, 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: 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 2304) has been filed by Idemitsu Kosan, Cp. 
Ltd., Agri-Bio Business Dept., 1-1 Marunouchi 3-Chome, Chiyoda-Ku, 
Tokyo 1000-8321, Japan. 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 (21 CFR 573.940) as a carrier for 
flavors for use in animal 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: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20385 Filed 9-22-17; 8:45 am]
BILLING CODE 4164-01-P



                                                      44542               Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Proposed Rules

                                                      to support IFR operations for instrument                Availability and Summary of                           with FAA Order 1050.1F,
                                                      approach procedures at the airport.                     Documents for Incorporation by                        ‘‘Environmental Impacts: Policies and
                                                                                                              Reference                                             Procedures’’ prior to any FAA final
                                                      Comments Invited                                                                                              regulatory action.
                                                                                                                This document proposes to amend
                                                         Interested parties are invited to                    FAA Order 7400.11B, Airspace                          List of Subjects in 14 CFR Part 71
                                                      participate in this proposed rulemaking                 Designations and Reporting Points,
                                                                                                              dated August 3, 2017, and effective                    Airspace, Incorporation by reference,
                                                      by submitting such written data, views,
                                                                                                              September 15, 2017. FAA Order                         Navigation (air).
                                                      or arguments, as they may desire.
                                                      Comments that provide the factual basis                 7400.11B is publicly available as listed              The Proposed Amendment
                                                      supporting the views and suggestions                    in the ADDRESSES section of this
                                                                                                              document. FAA Order 7400.11B lists                      Accordingly, pursuant to the
                                                      presented are particularly helpful in                                                                         authority delegated to me, the Federal
                                                      developing reasoned regulatory                          Class A, B, C, D, and E airspace areas,
                                                                                                              air traffic service routes, and reporting             Aviation Administration proposes to
                                                      decisions on the proposal. Comments                                                                           amend 14 CFR part 71 as follows:
                                                                                                              points.
                                                      are specifically invited on the overall
                                                      regulatory, aeronautical, economic,                     The Proposal                                          PART 71—DESIGNATION OF CLASS A,
                                                      environmental, and energy-related                          The FAA is proposing an amendment                  B, C, D, AND E AIRSPACE AREAS; AIR
                                                      aspects of the proposal.                                to Title 14, Code of Federal Regulations              TRAFFIC SERVICE ROUTES; AND
                                                      Communications should identify both                     (14 CFR) part 71 by modifying Class E                 REPORTING POINTS
                                                      docket numbers and be submitted in                      airspace area extending upward from                   ■ 1. The authority citation for 14 CFR
                                                      triplicate to the address listed above.                 700 feet above the surface within a 6.4-              part 71 continues to read as follows:
                                                      Commenters wishing the FAA to                           mile radius (increased from a 6.3-mile
                                                      acknowledge receipt of their comments                   radius) at Fitch H. Beach, Charlotte, MI,               Authority: 49 U.S.C. 106(f), 106(g); 40103,
                                                                                                              and updating the geographic                           40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
                                                      on this notice must submit with those                                                                         1959–1963 Comp., p. 389.
                                                      comments a self-addressed, stamped                      coordinates of the airport to coincide
                                                      postcard on which the following                         with the FAA’s aeronautical database.                 § 71.1       [Amended]
                                                      statement is made: ‘‘Comments to                        The exclusionary language contained in                ■ 2. The incorporation by reference in
                                                      Docket No. FAA–2017–0721/Airspace                       the airspace description is being                     14 CFR 71.1 of FAA Order 7400.11B,
                                                      Docket No. 17–AGL–15.’’ The postcard                    removed to comply with FAA Order                      Airspace Designations and Reporting
                                                      will be date/time stamped and returned                  7400.2L, Procedures for Handling                      Points, dated August 3, 2017, and
                                                                                                              Airspace Matters.                                     effective September 15, 2017, is
                                                      to the commenter.                                          Class E airspace designations are
                                                         All communications received before                                                                         amended as follows:
                                                                                                              published in paragraph 6005 of FAA
                                                      the specified closing date for comments                 Order 7400.11B, dated August 3, 2017,                 Paragraph 6005 Class E Airspace Areas
                                                      will be considered before taking action                 and effective September 15, 2017, which               Extending Upward From 700 Feet or More
                                                      on the proposed rule. The proposal                      is incorporated by reference in 14 CFR                Above the Surface of the Earth.
                                                      contained in this notice may be changed                 71.1. The Class E airspace designations               *        *      *    *    *
                                                      in light of the comments received. A                    listed in this document will be                       AGL MI E5 Charlotte, MI [Amended]
                                                      report summarizing each substantive                     published subsequently in the Order.
                                                                                                                                                                    Charlotte, Fitch H. Beach Airport, MI
                                                      public contact with FAA personnel                       Regulatory Notices and Analyses                         (Lat. 42°34′27″ N., long. 84°48′44″ W.)
                                                      concerned with this rulemaking will be                                                                          That airspace extending upward from 700
                                                      filed in the docket.                                      The FAA has determined that this
                                                                                                              proposed regulation only involves an                  feet above the surface within a 6.4-mile
                                                                                                              established body of technical                         radius of the Fitch H. Beach Airport.
                                                      Availability of NPRMs
                                                                                                              regulations for which frequent and                      Issued in Fort Worth, Texas, on September
                                                        An electronic copy of this document                   routine amendments are necessary to                   13, 2017.
                                                      may be downloaded through the                           keep them operationally current, is non-              Walter Tweedy,
                                                      Internet at http://www.regulations.gov.                 controversial and unlikely to result in               Acting Manager, Operations Support Group,
                                                      Recently published rulemaking                           adverse or negative comments. It,                     ATO Central Service Center.
                                                      documents can also be accessed through                  therefore: (1) Is not a ‘‘significant                 [FR Doc. 2017–20329 Filed 9–22–17; 8:45 am]
                                                      the FAA’s Web page at http://                           regulatory action’’ under Executive                   BILLING CODE 4910–13–P
                                                      www.faa.gov/air_traffic/publications/                   Order 12866; (2) is not a ‘‘significant
                                                      airspace_amendments/.                                   rule’’ under DOT Regulatory Policies
                                                        You may review the public docket                      and Procedures (44 FR 11034; February                 DEPARTMENT OF HEALTH AND
                                                      containing the proposal, any comments                   26, 1979); and (3) does not warrant                   HUMAN SERVICES
                                                      received, and any final disposition in                  preparation of a regulatory evaluation as
                                                                                                              the anticipated impact is so minimal.                 Food and Drug Administration
                                                      person in the Dockets Office (see the
                                                                                                              Since this is a routine matter that will
                                                      ADDRESSES section for the address and
                                                                                                              only affect air traffic procedures and air            21 CFR Part 573
                                                      phone number) between 9:00 a.m. and
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                                                                              navigation, it is certified that this
                                                      5:00 p.m., Monday through Friday,                       proposed rule, when promulgated,                      [Docket No. FDA–2017–F–5528]
                                                      except federal holidays. An informal                    would not have a significant economic
                                                      docket may also be examined during                                                                            Idemitsu Kosan, Cp. Ltd.; Filing of
                                                                                                              impact on a substantial number of small
                                                      normal business hours at the Federal                                                                          Food Additive Petition (Animal Use)
                                                                                                              entities under the criteria of the
                                                      Aviation Administration, Air Traffic                    Regulatory Flexibility Act.                           AGENCY:       Food and Drug Administration,
                                                      Organization, Central Service Center,                                                                         HHS.
                                                      Operations Support Group, 10101                         Environmental Review
                                                                                                                                                                    ACTION:Notification; petition for
                                                      Hillwood Parkway, Fort Worth, TX                          This proposal will be subject to an
                                                                                                                                                                    rulemaking.
                                                      76177.                                                  environmental analysis in accordance


                                                 VerDate Sep<11>2014   17:07 Sep 22, 2017   Jkt 241001   PO 00000   Frm 00004   Fmt 4702   Sfmt 4702   E:\FR\FM\25SEP1.SGM   25SEP1


                                                                          Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Proposed Rules                                                 44543

                                                      SUMMARY:   The Food and Drug                            DEPARTMENT OF THE TREASURY                            whose disclosure is restricted by statute.
                                                      Administration (FDA or we) is                                                                                 Multimedia submissions (audio, video,
                                                      announcing that Idemitsu Kosan, Cp.                     Internal Revenue Service                              etc.) must be accompanied by a written
                                                      Ltd. has filed a petition proposing that                                                                      comment. The written comment is
                                                      the food additive regulations be                        26 CFR Parts 1, 5f, and 46                            considered the official comment and
                                                      amended to provide for the safe use of                  [REG–125374–16]                                       should include discussion of all points
                                                      silicon dioxide as a carrier for flavors for                                                                  you wish to make. EPA will generally
                                                      use in animal feed.                                     RIN 1545–BN60                                         not consider comments or comment
                                                                                                              Guidance on the Definition of                         contents located outside of the primary
                                                      DATES:  The food additive petition was
                                                                                                              Registered Form                                       submission (i.e. on the web, cloud, or
                                                      filed on August 7, 2017.
                                                                                                                                                                    other file sharing system). For
                                                      ADDRESSES:   For access to the docket, go               Correction                                            additional submission methods, the full
                                                      to https://www.regulations.gov and                         In proposed rule document 2017–                    EPA public comment policy,
                                                      insert the docket number, found in                      19753, appearing on pages 43720                       information about CBI or multimedia
                                                      brackets in the heading of this                         through 43730, in the issue of Tuesday,               submissions, and general guidance on
                                                      document, into the ‘‘Search’’ box and                   September 19, 2017, make the following                making effective comments, please visit
                                                      follow the prompts; and/or go to the                    correction:                                           http://www2.epa.gov/dockets/
                                                      Dockets Management Staff, 5630 Fishers                     On page 43725, in the second column,               commenting-epa-dockets.
                                                      Lane, Rm. 1061, Rockville, MD 20852.                    at the bottom of the column, under the                FOR FURTHER INFORMATION CONTACT:
                                                      FOR FURTHER INFORMATION CONTACT:
                                                                                                              heading ‘‘Partial Withdrawal of Notice
                                                                                                                                                                    Sean Lakeman, Air Regulatory
                                                      Chelsea Trull, Center for Veterinary                    of Proposed Rulemaking,’’ on the
                                                                                                                                                                    Management Section, Air Planning and
                                                                                                              second line of the paragraph, ‘‘5f.163–
                                                      Medicine, Food and Drug                                                                                       Implementation Branch, Air, Pesticides
                                                                                                              1(b)(2)’’ should read ‘‘§ 5f.163–1(b)(2)’’.
                                                      Administration, 7519 Standish Pl.,                                                                            and Toxics Management Division, U.S.
                                                                                                              [FR Doc. C1–2017–19753 Filed 9–22–17; 8:45 am]
                                                      Rockville, MD 20855, 240–402–6729,                                                                            Environmental Protection Agency,
                                                                                                              BILLING CODE 1301–00–D
                                                      chelsea.trull@fda.hhs.gov.                                                                                    Region 4, 61 Forsyth Street SW.,
                                                      SUPPLEMENTARY INFORMATION:      Under the                                                                     Atlanta, Georgia 30303–8960. Mr.
                                                      Federal Food, Drug, and Cosmetic Act                                                                          Lakeman can be reached via telephone
                                                                                                              ENVIRONMENTAL PROTECTION                              at (404) 562–9043 or via electronic mail
                                                      (section 409(b)(5) (21 U.S.C. 348(b)(5))),              AGENCY
                                                      notice is given that a food additive                                                                          at lakeman.sean@epa.gov.
                                                      petition (FAP 2304) has been filed by                   40 CFR Part 52                                        SUPPLEMENTARY INFORMATION:        In the
                                                      Idemitsu Kosan, Cp. Ltd., Agri-Bio                                                                            Final Rules section of this Federal
                                                                                                              [EPA–R04–OAR–2009–0226; FRL–9968–16–
                                                      Business Dept., 1–1 Marunouchi 3-                       Region 4]                                             Register, EPA is approving the State’s
                                                      Chome, Chiyoda-Ku, Tokyo 1000–8321,                                                                           implementation plan revision as a direct
                                                      Japan. The petition proposes to amend                   Air Plan Approval; GA: Emission                       final rule without prior proposal
                                                      Title 21 of the Code of Federal                         Reduction Credits                                     because the Agency views this as a
                                                      Regulations (CFR) in part 573 (21 CFR                                                                         noncontroversial submittal and
                                                                                                              AGENCY:  Environmental Protection
                                                      part 573) Food Additives Permitted in                                                                         anticipates no adverse comments. A
                                                                                                              Agency.
                                                      Feed and Drinking Water of Animals to                                                                         detailed rationale for the approval is set
                                                      provide for the safe use of silicon                     ACTION: Proposed rule.
                                                                                                                                                                    forth in the direct final rule. If no
                                                      dioxide (21 CFR 573.940) as a carrier for               SUMMARY:   The Environmental Protection               adverse comments are received in
                                                      flavors for use in animal feed.                         Agency (EPA) is proposing to approve                  response to this rule, no further activity
                                                         The petitioner has claimed that this                 changes to the Georgia State                          is contemplated. If EPA receives adverse
                                                      action is categorically excluded under                  Implementation Plan (SIP) to update the               comments, the direct final rule will be
                                                      21 CFR 25.32(r) because it is of a type                 emission reduction credits regulation.                withdrawn and all public comments
                                                      that does not individually or                           EPA is proposing to approve portions of               received will be addressed in a
                                                      cumulatively have a significant effect on               the SIP revision submitted by the State               subsequent final rule based on this
                                                      the human environment. In addition,                     of Georgia, through the Georgia                       proposed rule. EPA will not institute a
                                                      the petitioner has stated that, to their                Department of Natural Resources’                      second comment period on this
                                                      knowledge, no extraordinary                             Environmental Protection Division on                  document. Any parties interested in
                                                      circumstances exist. If FDA determines                  September 15, 2008. This action is being              commenting on this document should
                                                      a categorical exclusion applies, neither                taken pursuant to the Clean Air Act.                  do so at this time.
                                                      an environmental assessment nor an                      DATES: Written comments must be                         Dated: September 13, 2017.
                                                      environmental impact statement is                       received on or before October 25, 2017.
                                                                                                                                                                    Onis ‘‘Trey’’ Glenn, III,
                                                      required. If FDA determines a                           ADDRESSES: Submit your comments,
                                                                                                                                                                    Regional Administrator, Region 4.
                                                      categorical exclusion does not apply, we                identified by Docket ID No. EPA–R04–
                                                                                                                                                                    [FR Doc. 2017–20337 Filed 9–22–17; 8:45 am]
                                                      will request an environmental                           OAR–2009–0226 at http://
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                      assessment and make it available for                    www.regulations.gov. Follow the online                BILLING CODE 6560–50–P

                                                      public inspection.                                      instructions for submitting comments.
                                                        Dated: September 19, 2017.
                                                                                                              Once submitted, comments cannot be
                                                                                                              edited or removed from Regulations.gov.
                                                      Anna K. Abram,                                          EPA may publish any comment received
                                                      Deputy Commissioner for Policy, Planning,               to its public docket. Do not submit
                                                      Legislation, and Analysis.                              electronically any information you
                                                      [FR Doc. 2017–20385 Filed 9–22–17; 8:45 am]             consider to be Confidential Business
                                                      BILLING CODE 4164–01–P                                  Information (CBI) or other information


                                                 VerDate Sep<11>2014   17:07 Sep 22, 2017   Jkt 241001   PO 00000   Frm 00005   Fmt 4702   Sfmt 9990   E:\FR\FM\25SEP1.SGM   25SEP1



Document Created: 2018-10-24 14:43:56
Document Modified: 2018-10-24 14:43:56
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 August 7, 2017.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation82 FR 44542 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR