80_FR_66186 80 FR 65978 - Grocery Manufacturers Association; Filing of Food Additive Petition

80 FR 65978 - Grocery Manufacturers Association; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 208 (October 28, 2015)

Page Range65978-65979
FR Document2015-27277

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Grocery Manufacturers Association, proposing that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in various food applications.

Federal Register, Volume 80 Issue 208 (Wednesday, October 28, 2015)
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Proposed Rules]
[Pages 65978-65979]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2015-F-3663]


Grocery Manufacturers Association; Filing of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by the Grocery Manufacturers 
Association, proposing that the food additive regulations be amended to 
provide for the safe use of partially hydrogenated vegetable oils 
(PHOs) in various food applications.

DATES: This food additive petition was filed on October 1, 2015. Submit 
either electronic or written comments on the petitioner's environmental 
assessment by November 27, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-F-3663 for ``Grocery Manufacturers Association; Filing of Food 
Additive Petition''. Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 5A4811), submitted by 
the Grocery Manufacturers Association, 1350 I Street, NW., Suite 300, 
Washington, DC 20005. The petition proposes to amend the food additive 
regulations in 21 CFR part 172 Food Additives Permitted for Direct 
Addition to Food for Human Consumption to provide for the safe use of 
PHOs in the following food applications at specified maximum use 
levels: As a carrier or component thereof for flavors or flavorings, as 
a diluent or component thereof for color additives, as an incidental 
additive or processing aid, and as a direct additive in specific foods.
    We are reviewing the potential environmental impact of this 
petition. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the environmental assessment submitted with the petition 
that is the subject of this notice on public display at the Division of 
Dockets Management (see DATES and ADDRESSES) for public review and 
comment.
    We will also place on public display, in the Division of Dockets 
Management and at http://www.regulations.gov, any amendments to, or 
comments on, the petitioner's environmental assessment without further 
announcement in the Federal Register. If, based on our review, we find 
that an environmental impact statement is not required, and this 
petition results in a regulation, we will publish the notice of 
availability of our finding of no significant impact and the evidence 
supporting that finding with the regulation in the Federal Register in 
accordance with 21 CFR 25.51(b).


[[Page 65979]]


    Dated: October 22, 2015.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2015-27277 Filed 10-27-15; 8:45 am]
 BILLING CODE 4164-01-P



                                               65978               Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Proposed Rules

                                                 Dated: October 22, 2015.                              manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                               Brent J. Fields,                                        Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                               Secretary.                                                                                                    electronic and written/paper comments
                                                                                                       Written/Paper Submissions
                                               [FR Doc. 2015–27385 Filed 10–27–15; 8:45 am]                                                                  received, go to http://
                                               BILLING CODE 8011–01–P
                                                                                                          Submit written/paper submissions as                www.regulations.gov and insert the
                                                                                                       follows:                                              docket number, found in brackets in the
                                                                                                          • Mail/Hand delivery/Courier (for                  heading of this document, into the
                                               DEPARTMENT OF HEALTH AND                                written/paper submissions): Division of               ‘‘Search’’ box and follow the prompts
                                               HUMAN SERVICES                                          Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                                                                                       and Drug Administration, 5630 Fishers                 Management, 5630 Fishers Lane, Rm.
                                               Food and Drug Administration                            Lane, Rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                                                                                          • For written/paper comments
                                                                                                                                                             FOR FURTHER INFORMATION CONTACT:
                                               21 CFR Part 172                                         submitted to the Division of Dockets
                                                                                                       Management, FDA will post your                        Ellen Anderson, Center for Food Safety
                                               [Docket No. FDA–2015–F–3663]
                                                                                                       comment, as well as any attachments,                  and Applied Nutrition (HFS–265), Food
                                                                                                       except for information submitted,                     and Drug Administration, 5100 Paint
                                               Grocery Manufacturers Association;                                                                            Branch Pkwy., College Park, MD 20740–
                                               Filing of Food Additive Petition                        marked and identified, as confidential,
                                                                                                       if submitted as detailed in                           3835, 240–402–1309.
                                               AGENCY:    Food and Drug Administration,                ‘‘Instructions.’’                                     SUPPLEMENTARY INFORMATION:       Under the
                                               HHS.                                                       Instructions: All submissions received             Federal Food, Drug, and Cosmetic Act
                                               ACTION:   Notice of petition.                           must include the Docket No. FDA–                      (section 409(b)(5) (21 U.S.C. 348(b)(5))),
                                                                                                       2015–F–3663 for ‘‘Grocery                             we are giving notice that we have filed
                                               SUMMARY:   The Food and Drug                            Manufacturers Association; Filing of                  a food additive petition (FAP 5A4811),
                                               Administration (FDA or we) is                           Food Additive Petition’’. Received                    submitted by the Grocery Manufacturers
                                               announcing that we have filed a                         comments will be placed in the docket                 Association, 1350 I Street, NW., Suite
                                               petition, submitted by the Grocery                      and, except for those submitted as                    300, Washington, DC 20005. The
                                               Manufacturers Association, proposing                    ‘‘Confidential Submissions,’’ publicly                petition proposes to amend the food
                                               that the food additive regulations be                   viewable at http://www.regulations.gov                additive regulations in 21 CFR part 172
                                               amended to provide for the safe use of                  or at the Division of Dockets                         Food Additives Permitted for Direct
                                               partially hydrogenated vegetable oils                   Management between 9 a.m. and 4 p.m.,                 Addition to Food for Human
                                               (PHOs) in various food applications.                    Monday through Friday.                                Consumption to provide for the safe use
                                               DATES: This food additive petition was                     • Confidential Submissions—To                      of PHOs in the following food
                                               filed on October 1, 2015. Submit either                 submit a comment with confidential                    applications at specified maximum use
                                               electronic or written comments on the                   information that you do not wish to be                levels: As a carrier or component thereof
                                               petitioner’s environmental assessment                   made publicly available, submit your                  for flavors or flavorings, as a diluent or
                                               by November 27, 2015.                                   comments only as a written/paper                      component thereof for color additives,
                                               ADDRESSES: You may submit comments                      submission. You should submit two                     as an incidental additive or processing
                                               as follows:                                             copies total. One copy will include the               aid, and as a direct additive in specific
                                                                                                       information you claim to be confidential              foods.
                                               Electronic Submissions                                  with a heading or cover note that states
                                                                                                                                                                We are reviewing the potential
                                                 Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS
                                                                                                                                                             environmental impact of this petition.
                                               following way:                                          CONFIDENTIAL INFORMATION’’. The
                                                                                                                                                             To encourage public participation
                                                 • Federal eRulemaking Portal: http://                 Agency will review this copy, including
                                                                                                                                                             consistent with regulations issued under
                                               www.regulations.gov. Follow the                         the claimed confidential information, in
                                                                                                       its consideration of comments. The                    the National Environmental Policy Act
                                               instructions for submitting comments.
                                               Comments submitted electronically,                      second copy, which will have the                      (40 CFR 1501.4(b)), we are placing the
                                               including attachments, to http://                       claimed confidential information                      environmental assessment submitted
                                               www.regulations.gov will be posted to                   redacted/blacked out, will be available               with the petition that is the subject of
                                               the docket unchanged. Because your                      for public viewing and posted on http://              this notice on public display at the
                                               comment will be made public, you are                    www.regulations.gov. Submit both                      Division of Dockets Management (see
                                                                                                                                                             DATES and ADDRESSES) for public review
                                               solely responsible for ensuring that your               copies to the Division of Dockets
                                               comment does not include any                            Management. If you do not wish your                   and comment.
                                               confidential information that you or a                  name and contact information to be                       We will also place on public display,
                                               third party may not wish to be posted,                  made publicly available, you can                      in the Division of Dockets Management
                                               such as medical information, your or                    provide this information on the cover                 and at http://www.regulations.gov, any
                                               anyone else’s Social Security number, or                sheet and not in the body of your                     amendments to, or comments on, the
                                               confidential business information, such                 comments and you must identify this                   petitioner’s environmental assessment
                                               as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any                  without further announcement in the
                                               that if you include your name, contact                  information marked as ‘‘confidential’’                Federal Register. If, based on our
                                               information, or other information that                  will not be disclosed except in                       review, we find that an environmental
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                                               identifies you in the body of your                      accordance with 21 CFR 10.20 and other                impact statement is not required, and
                                               comments, that information will be                      applicable disclosure law. For more                   this petition results in a regulation, we
                                               posted on http://www.regulations.gov.                   information about FDA’s posting of                    will publish the notice of availability of
                                                 • If you want to submit a comment                     comments to public dockets, see 80 FR                 our finding of no significant impact and
                                               with confidential information that you                  56469, September 18, 2015, or access                  the evidence supporting that finding
                                               do not wish to be made available to the                 the information at: http://www.fda.gov/               with the regulation in the Federal
                                               public, submit the comment as a                         regulatoryinformation/dockets/                        Register in accordance with 21 CFR
                                               written/paper submission and in the                     default.htm.                                          25.51(b).


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                                                                   Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Proposed Rules                                         65979

                                                 Dated: October 22, 2015.                              Clinton East Building, 1201 Constitution              SUPPLEMENTARY INFORMATION:       The
                                               Dennis M. Keefe,                                        Avenue NW., Washington, DC 20004;                     hearings will provide interested parties
                                               Director, Office of Food Additive Safety,               and                                                   the opportunity to present data, views,
                                               Center for Food Safety and Applied Nutrition.              4. Atlanta, Georgia, on November 19–               or arguments concerning the proposed
                                               [FR Doc. 2015–27277 Filed 10–27–15; 8:45 am]            20, 2015, at the Sam Nunn Atlanta                     action. The EPA will make every effort
                                               BILLING CODE 4164–01–P                                  Federal Center Main Tower Bridge                      to accommodate all speakers who wish
                                                                                                       Conference Center, 61 Forsyth Street                  to register to speak at the hearing venue
                                                                                                       SW., Atlanta, Georgia 30303.                          on the day of the hearing. The EPA may
                                               ENVIRONMENTAL PROTECTION                                   The hearings on the first day in all               ask clarifying questions during the oral
                                               AGENCY                                                  locations will begin at 9:00 a.m. (local              presentations, but will not respond to
                                                                                                       time) and will conclude at 8:00 p.m.                  the presentations at that time. Written
                                               40 CFR Parts 60, 62, and 78                             (local time). The hearings on the second              statements and supporting information
                                                                                                       day in all locations will begin at 9:00               submitted during the comment period
                                               [EPA–HQ–OAR–2015–0199; FRL 9936–27–                                                                           will be considered with the same weight
                                               OAR]
                                                                                                       a.m. (local time) and will conclude at
                                                                                                       5:00 p.m. (local time). There will be a               as oral comments and supporting
                                               RIN 2060–AS47                                           lunch break from 12:00 p.m. to 1:00                   information presented at the public
                                                                                                       p.m. and a dinner break from 5:00 p.m.                hearing. Verbatim transcripts of the
                                               Federal Plan Requirements for                           to 6:00 p.m. (on the first day of hearings            hearing and written statements will be
                                               Greenhouse Gas Emissions From                           only).                                                included in the docket for the
                                               Electric Utility Generating Units                                                                             rulemaking. The EPA plans for the
                                                                                                       FOR FURTHER INFORMATION CONTACT: To
                                               Constructed on or Before January 8,                                                                           hearings to run on schedule; however,
                                                                                                       register to speak at a hearing, please use
                                               2014; Model Trading Rules;                                                                                    due to on-site schedule fluctuations,
                                                                                                       the online registration form available at
                                               Amendments to Framework                                                                                       actual speaking times may shift slightly.
                                                                                                       http://www.epa.gov/cleanpowerplan or
                                               Regulations                                                                                                      Because these hearings are being held
                                                                                                       contact Ms. Virginia Hunt at (919) 541–
                                                                                                                                                             at United States government facilities,
                                               AGENCY: Environmental Protection                        0832 or at hunt.virginia@epa.gov. The
                                                                                                                                                             individuals planning to attend the
                                               Agency (EPA).                                           last day to pre-register to speak at the
                                                                                                                                                             hearing should be prepared to show
                                               ACTION: Notice of public hearings.                      Pittsburgh, Pennsylvania, hearing will
                                                                                                                                                             valid picture identification to the
                                                                                                       be Tuesday, November 10, 2015, and the
                                                                                                                                                             security staff in order to gain access to
                                               SUMMARY:    The Environmental Protection                last day to pre-register to speak at the              the meeting room. Please note that the
                                               Agency (EPA) is announcing four public                  Denver, Colorado, Washington, DC, and                 REAL ID Act, passed by Congress in
                                               hearings to be held on the proposed                     Atlanta, Georgia, hearings will be                    2005, established new requirements for
                                               ‘‘Federal Plan Requirements for                         Thursday, November 12, 2015.                          entering federal facilities. If your
                                               Greenhouse Gas Emissions from Electric                  Additionally, requests to speak will be               driver’s license is issued by Alaska,
                                               Utility Generating Units Constructed on                 taken the day of each hearing at the                  American Samoa, Arizona, Kentucky,
                                               or before January 8, 2014; Model                        hearing registration desk, although                   Louisiana, Maine, Massachusetts,
                                               Trading Rules; Amendments to                            preferences on speaking times may not                 Minnesota, Montana, New York,
                                               Framework Regulations.’’                                be able to be fulfilled. Please note that             Oklahoma, or the state of Washington,
                                               DATES: The EPA will be holding four                     registration requests received before                 you must present an additional form of
                                               public hearings on the proposed federal                 each hearing will be confirmed by the                 identification to enter the federal
                                               plan to accept oral comments.                           EPA via email. We cannot guarantee                    building. Acceptable alternative forms
                                                  The hearings will be held:                           that we can accommodate all timing                    of identification include: Federal
                                                  1. November 12–13, 2015 in                           requests and will provide requestors                  employee badges, passports, enhanced
                                               Pittsburgh, PA.                                         with the next available speaking time, in             driver’s licenses, and military
                                                  2. November 16–17, 2015, in Denver,                  the event that their requested time is                identification cards. In addition, you
                                               Colorado.                                               taken. Please note that the time outlined             will need to obtain a property pass for
                                                  3. November 18–19, 2015 in                           in the confirmation email received will               any personal belongings you bring with
                                               Washington, DC.                                         be the scheduled speaking time. Again,                you. Upon leaving the building, you
                                                  4. November 19–20, 2015 in Atlanta,                  depending on the flow of the day, times               will be required to return this property
                                               Georgia.                                                may fluctuate. If you require the service             pass to the security desk. No large signs
                                                  The first hearing day in all locations               of a translator or special                            will be allowed in the building, cameras
                                               will begin at 9:00 a.m. (local time) and                accommodations such as audio                          may only be used outside of the
                                               will conclude at 8:00 p.m. (local time).                description, we ask that you pre-register             building, and demonstrations will not
                                               The second hearing day in all locations                 for the hearings by Friday, November 6,               be allowed on federal property for
                                               will begin at 9:00 a.m. (local time) and                2015, as we may not be able to arrange                security reasons.
                                               conclude at 5:00 p.m. (local time).                     such accommodations without advance                      Attendees will be asked to go through
                                               ADDRESSES: The hearings will be held                    notice. Please note that any updates                  metal detectors. To help facilitate this
                                               in:                                                     made to any aspect of the hearings will               process, please be advised that you will
                                                  1. Pittsburgh, Pennsylvania, on                      be posted online at http://www.epa.gov/               be asked to remove all items from all
                                               November 12–13, at the William S.                       cleanpowerplan. While the EPA expects                 pockets and place them in provided
                                               Moorhead Federal Building, 1000                         the hearings to go forward as set forth               bins for screening; remove laptops,
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                                               Liberty Avenue, Room 1310, Pittsburgh,                  above, we ask that you monitor our Web                phones, or other electronic devices from
                                               Pennsylvania 15222;                                     site or contact Ms. Virginia Hunt at                  their carrying case and place in
                                                  2. Denver, Colorado, on November                     (919) 541–0832 or at                                  provided bins for screening; avoid shoes
                                               16–17, 2015, at the EPA Region 8 office,                hunt.virginia@epa.gov to determine if                 with metal shanks, toe guards, or
                                               1595 Wynkoop Street, Denver, Colorado                   there are any updates to the information              supports as a part of their construction;
                                               80202;                                                  on the hearings. The EPA does not                     remove any metal belts, metal belt
                                                  3. Washington, DC, on November 18–                   intend to publish a notice in the Federal             buckles, large jewelry, watches, and
                                               19, 2015, at the EPA William Jefferson                  Register announcing any such updates.                 follow the instructions of the guard if


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Document Created: 2018-02-27 08:58:15
Document Modified: 2018-02-27 08:58:15
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
ActionNotice of petition.
DatesThis food additive petition was filed on October 1, 2015. Submit either electronic or written comments on the petitioner's environmental assessment by November 27, 2015.
ContactEllen Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.
FR Citation80 FR 65978 

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