80_FR_73419 80 FR 73193 - Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry; Availability

80 FR 73193 - Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 226 (November 24, 2015)

Page Range73193-73194
FR Document2015-29904

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon: Guidance for Industry.'' We developed the draft guidance to assist food manufacturers that wish to voluntarily label their food product or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered (GE) Atlantic salmon.

Federal Register, Volume 80 Issue 226 (Tuesday, November 24, 2015)
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73193-73194]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29904]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4272]


Voluntary Labeling Indicating Whether Food Has or Has Not Been 
Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Voluntary 
Labeling Indicating Whether Food Has or Has Not Been Derived From 
Genetically Engineered Atlantic Salmon: Guidance for Industry.'' We 
developed the draft guidance to assist food manufacturers that wish to 
voluntarily label their food product or ingredients (for humans or 
animals) derived from Atlantic salmon as either containing or not 
containing products from genetically engineered (GE) Atlantic salmon.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that FDA considers your comment on the draft 
guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
January 25, 2016.

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-D-4272 for ``Voluntary Labeling Indicating Whether Food Has or 
Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft 
Guidance for Industry.'' 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.
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition, Labeling, and Dietary Supplements (HFS-820), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist the office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

[[Page 73194]]


FOR FURTHER INFORMATION CONTACT: Regarding human food issues: Andrea 
Krause, Center for Food Safety and Applied Nutrition (HFS-820), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-2371. Regarding animal food issues: Kathleen Jones, 
Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 240-402-7077.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Voluntary Labeling Indicating Whether Food Has or Has Not 
Been Derived From Genetically Engineered Atlantic Salmon.'' We are 
issuing the draft guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the current thinking of FDA on this topic. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.
    On November 19, 2015, FDA approved a new animal drug application 
(NADA) related to AquAdvantage Salmon, a GE Atlantic salmon. This is 
FDA's first approval of an NADA in support of a GE animal for use as 
food. According to information in the NADA, AquAdvantage Salmon is 
genetically engineered to reach market size in a shorter period than 
non-GE farm-raised Atlantic salmon. FDA's Center for Veterinary 
Medicine reviewed the NADA and made a determination concerning the 
safety and effectiveness of the new animal drug in AquAdvantage Salmon.
    In terms of labeling of food derived from AquAdvantage Salmon, the 
law requires, among other things, that the label includes a name that 
accurately describes the basic nature of a food and any other 
information that is considered material with regard to consequences 
that may result from the use of the food. In a 1992 policy on foods 
derived from new plant varieties and a 2001 draft guidance on voluntary 
labeling of food from GE plants, we explained that: Name changes are 
appropriate when a food from a GE plant is materially different from 
its traditional counterpart, such that the common or usual name no 
longer adequately describes the new food; or when there are other 
material differences that affect the food's nutritional or functional 
characteristics.\1\ (Elsewhere in this issue of the Federal Register, 
we are announcing the availability of a final guidance entitled 
``Guidance for Industry: Voluntary Labeling Indicating Whether Foods 
Have or Have Not Been Derived from Genetically Engineered Plants.'') 
Changes to the name of the product or other additional labeling are not 
required if the resulting food is not materially different from its 
non-genetically engineered counterpart.
---------------------------------------------------------------------------

    \1\ See 57 FR 22984, May 29, 1992.
---------------------------------------------------------------------------

    In the process of deciding whether or not to require additional 
labeling of AquAdvantage Salmon, FDA considered whether food from 
AquAdvantage Salmon is materially different from non-GE, farm-raised 
Atlantic salmon. As part of our evaluation, we assessed data and 
information submitted in response to our August 26, 2010, Federal 
Register document entitled ``Food Labeling; Labeling of Food Made From 
AquAdvantage Salmon; Public Hearing; Request for Comments'' (75 FR 
52602), as well as data and information submitted by the sponsor.
    Based on our review of the sponsor's data and information, and 
other information available to the Agency (e.g., FDA's laboratory 
analyses establishing that AquAdvantage Salmon meets the criteria for 
Atlantic salmon established for the Regulatory Fish Encyclopedia), we 
found that the composition, nutritional profile, and safety of food 
from AquAdvantage Salmon do not differ from food from non-GE, farm-
raised Atlantic salmon in any material way, and thus it is as safe and 
nutritious as food from non-GE, farm-raised Atlantic salmon. For these 
reasons, we concluded that there is no basis to require additional 
labeling of food derived from AquAdvantage Salmon.2 3
---------------------------------------------------------------------------

    \2\ We note that, if a different GE salmon is developed in the 
future, we will separately assess the data and information about 
that salmon to determine whether it differs materially from non-GE 
salmon and, as such, whether additional labeling would be required 
on food derived from that salmon.
    \3\ Memorandum to File: Office of Nutrition, Labeling and 
Dietary Supplements, CFSAN: Evaluation of data and information and 
recommendations related to the labeling of food from AquAdvantage 
Salmon.
---------------------------------------------------------------------------

II. Guidance on Voluntary Labeling

    Recognizing that some consumers are interested in whether a food 
contains GE Atlantic salmon and some manufacturers may want to respond 
to this consumer interest, we developed this draft guidance to assist 
food manufacturers that wish to voluntarily label their food product or 
ingredients (for humans or animals) as either containing or not 
containing products from GE Atlantic salmon. FDA's main concern within 
the context of this guidance is that any voluntary labeling be truthful 
and not misleading.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. This draft guidance contains proposed collections 
of information. ``Collection of information'' is defined in 44 U.S.C. 
3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a 
60-day notice in the Federal Register soliciting public comment on each 
proposed collection of information before submitting the collection to 
OMB for approval. To comply with this requirement, FDA will publish a 
60-day notice on the proposed collections of information in this draft 
guidance in a future issue of the Federal Register.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use 
the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: November 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29904 Filed 11-23-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                                             Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices                                            73193

                                                  CPSTF findings and recommendations                      from genetically engineered (GE)                       Guidance for Industry.’’ Received
                                                  and the systematic reviews on which                     Atlantic salmon.                                       comments will be placed in the docket
                                                  they are based are available at http://                 DATES: Although you can comment on                     and, except for those submitted as
                                                  www.thecommunityguide.org/                              any guidance at any time (see 21 CFR                   ‘‘Confidential Submissions,’’ publicly
                                                  index.html.                                             10.115(g)(5)), to ensure that FDA                      viewable at http://www.regulations.gov
                                                  Time Commitment                                         considers your comment on the draft                    or at the Division of Dockets
                                                                                                          guidance before it begins work on the                  Management between 9 a.m. and 4 p.m.,
                                                    The CPSTF conducts three, two-day                     final version of the guidance, submit                  Monday through Friday.
                                                  meetings each year that are open to the                 either electronic or written comments                     • Confidential Submissions—To
                                                  public. In addition, a significant portion              on the draft guidance by January 25,                   submit a comment with confidential
                                                  of the CPSTF’s work occurs between                      2016.                                                  information that you do not wish to be
                                                  meetings during conference calls and                                                                           made publicly available, submit your
                                                  via email discussions. Member duties                    ADDRESSES:        You may submit comments
                                                                                                                                                                 comments only as a written/paper
                                                  include overseeing the process of                       as follows:
                                                                                                                                                                 submission. You should submit two
                                                  prioritizing Task Force work,                           Electronic Submissions                                 copies total. One copy will include the
                                                  participating in the development and                                                                           information you claim to be confidential
                                                  refinement of systematic review                           Submit electronic comments in the
                                                                                                          following way:                                         with a heading or cover note that states
                                                  methods, serving as members of                                                                                 ‘‘THIS DOCUMENT CONTAINS
                                                  individual review teams, and issuing                      • Federal eRulemaking Portal: http://
                                                                                                          www.regulations.gov. Follow the                        CONFIDENTIAL INFORMATION.’’ The
                                                  recommendations and findings to help                                                                           Agency will review this copy, including
                                                  inform the decision making process                      instructions for submitting comments.
                                                                                                          Comments submitted electronically,                     the claimed confidential information, in
                                                  about policy, practice, research, and                                                                          its consideration of comments. The
                                                  research funding in a wide range of U.S.                including attachments, to http://
                                                                                                          www.regulations.gov will be posted to                  second copy, which will have the
                                                  settings. The estimated workload for                                                                           claimed confidential information
                                                  CPSTF members is approximately 168                      the docket unchanged. Because your
                                                                                                          comment will be made public, you are                   redacted/blacked out, will be available
                                                  hours a year in addition to the three in-                                                                      for public viewing and posted on
                                                  person meetings. The members are all                    solely responsible for ensuring that your
                                                                                                          comment does not include any                           http://www.regulations.gov. Submit
                                                  volunteers and do not receive any                                                                              both copies to the Division of Dockets
                                                  compensation beyond support for travel                  confidential information that you or a
                                                                                                          third party may not wish to be posted,                 Management. If you do not wish your
                                                  to in-person meetings.                                                                                         name and contact information to be
                                                                                                          such as medical information, your or
                                                    Dated: November 19, 2015.                                                                                    made publicly available, you can
                                                                                                          anyone else’s Social Security number, or
                                                  Sandra Cashman,                                         confidential business information, such                provide this information on the cover
                                                  Acting Director, Division of the Executive              as a manufacturing process. Please note                sheet and not in the body of your
                                                  Secretariat, Office of the Chief of Staff,              that if you include your name, contact                 comments and you must identify this
                                                  Centers for Disease Control and Prevention.                                                                    information as ‘‘confidential.’’ Any
                                                                                                          information, or other information that
                                                  [FR Doc. 2015–29882 Filed 11–23–15; 8:45 am]
                                                                                                          identifies you in the body of your                     information marked as ‘‘confidential’’
                                                  BILLING CODE 4163–18–P                                  comments, that information will be                     will not be disclosed except in
                                                                                                          posted on http://www.regulations.gov.                  accordance with 21 CFR 10.20 and other
                                                                                                            • If you want to submit a comment                    applicable disclosure law. For more
                                                  DEPARTMENT OF HEALTH AND                                with confidential information that you                 information about FDA’s posting of
                                                  HUMAN SERVICES                                          do not wish to be made available to the                comments to public dockets, see 80 FR
                                                                                                          public, submit the comment as a                        56469, September 18, 2015, or access
                                                  Food and Drug Administration                                                                                   the information at: http://www.fda.gov/
                                                                                                          written/paper submission and in the
                                                  [Docket No. FDA–2015–D–4272]                            manner detailed (see ‘‘Written/Paper                   regulatoryinformation/dockets/
                                                                                                          Submissions’’ and ‘‘Instructions’’).                   default.htm.
                                                  Voluntary Labeling Indicating Whether                                                                             Docket: For access to the docket to
                                                  Food Has or Has Not Been Derived                        Written/Paper Submissions                              read background documents or the
                                                  From Genetically Engineered Atlantic                       Submit written/paper submissions as                 electronic and written/paper comments
                                                  Salmon; Draft Guidance for Industry;                    follows:                                               received, go to http://
                                                  Availability                                               • Mail/Hand delivery/Courier (for                   www.regulations.gov and insert the
                                                  AGENCY:    Food and Drug Administration,                written/paper submissions): Division of                docket number, found in brackets in the
                                                  HHS.                                                    Dockets Management (HFA–305), Food                     heading of this document, into the
                                                  ACTION:   Notice of availability.                       and Drug Administration, 5630 Fishers                  ‘‘Search’’ box and follow the prompts
                                                                                                          Lane, Rm. 1061, Rockville, MD 20852.                   and/or go to the Division of Dockets
                                                  SUMMARY:  The Food and Drug                                • For written/paper comments                        Management, 5630 Fishers Lane, Rm.
                                                  Administration (FDA or we) is                           submitted to the Division of Dockets                   1061, Rockville, MD 20852.
                                                  announcing the availability of a draft                  Management, FDA will post your                            Submit written requests for single
                                                  guidance for industry entitled                          comment, as well as any attachments,                   copies of the draft guidance to the Office
                                                  ‘‘Voluntary Labeling Indicating Whether                 except for information submitted,                      of Nutrition, Labeling, and Dietary
                                                  Food Has or Has Not Been Derived From                   marked and identified, as confidential,                Supplements (HFS–820), Center for
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  Genetically Engineered Atlantic                         if submitted as detailed in                            Food Safety and Applied Nutrition,
                                                  Salmon: Guidance for Industry.’’ We                     ‘‘Instructions.’’                                      Food and Drug Administration, 5100
                                                  developed the draft guidance to assist                     Instructions: All submissions received              Paint Branch Pkwy., College Park, MD
                                                  food manufacturers that wish to                         must include the Docket No. FDA–                       20740. Send two self-addressed
                                                  voluntarily label their food product or                 2015–D–4272 for ‘‘Voluntary Labeling                   adhesive labels to assist the office in
                                                  ingredients (for humans or animals)                     Indicating Whether Food Has or Has Not                 processing your request. See the
                                                  derived from Atlantic salmon as either                  Been Derived From Genetically                          SUPPLEMENTARY INFORMATION section for
                                                  containing or not containing products                   Engineered Atlantic Salmon; Draft                      electronic access to the draft guidance.


                                             VerDate Sep<11>2014   17:20 Nov 23, 2015   Jkt 238001   PO 00000   Frm 00032    Fmt 4703   Sfmt 4703   E:\FR\FM\24NON1.SGM   24NON1


                                                  73194                      Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices

                                                  FOR FURTHER INFORMATION CONTACT:                        characteristics.1 (Elsewhere in this issue            containing or not containing products
                                                  Regarding human food issues: Andrea                     of the Federal Register, we are                       from GE Atlantic salmon. FDA’s main
                                                  Krause, Center for Food Safety and                      announcing the availability of a final                concern within the context of this
                                                  Applied Nutrition (HFS–820), Food and                   guidance entitled ‘‘Guidance for                      guidance is that any voluntary labeling
                                                  Drug Administration, 5100 Paint Branch                  Industry: Voluntary Labeling Indicating               be truthful and not misleading.
                                                  Pkwy., College Park, MD 20740, 240–                     Whether Foods Have or Have Not Been
                                                                                                                                                                III. Paperwork Reduction Act of 1995
                                                  402–2371. Regarding animal food                         Derived from Genetically Engineered
                                                  issues: Kathleen Jones, Center for                      Plants.’’) Changes to the name of the                    Under the Paperwork Reduction Act
                                                  Veterinary Medicine (HFV–220), Food                     product or other additional labeling are              of 1995 (the PRA) (44 U.S.C. 3501–
                                                  and Drug Administration, 7519 Standish                  not required if the resulting food is not             3520), Federal Agencies must obtain
                                                  Pl., Rockville, MD 20855, 240–402–                      materially different from its non-                    approval from the Office of Management
                                                  7077.                                                   genetically engineered counterpart.                   and Budget (OMB) for each collection of
                                                                                                             In the process of deciding whether or              information they conduct or sponsor.
                                                  SUPPLEMENTARY INFORMATION:                              not to require additional labeling of                 This draft guidance contains proposed
                                                  I. Background                                           AquAdvantage Salmon, FDA considered                   collections of information. ‘‘Collection
                                                                                                          whether food from AquAdvantage                        of information’’ is defined in 44 U.S.C.
                                                     We are announcing the availability of                Salmon is materially different from non-              3502(3) and 5 CFR 1320.3(c) and
                                                  a draft guidance for industry entitled                  GE, farm-raised Atlantic salmon. As part              includes Agency requests or
                                                  ‘‘Voluntary Labeling Indicating Whether                 of our evaluation, we assessed data and               requirements that members of the public
                                                  Food Has or Has Not Been Derived From                   information submitted in response to                  submit reports, keep records, or provide
                                                  Genetically Engineered Atlantic                         our August 26, 2010, Federal Register                 information to a third party. Section
                                                  Salmon.’’ We are issuing the draft                      document entitled ‘‘Food Labeling;                    3506(c)(2)(A) of the PRA (44 U.S.C.
                                                  guidance consistent with our good                       Labeling of Food Made From                            3506(c)(2)(A)) requires Federal Agencies
                                                  guidance practices regulation (21 CFR                   AquAdvantage Salmon; Public Hearing;                  to publish a 60-day notice in the
                                                  10.115). The draft guidance, when                       Request for Comments’’ (75 FR 52602),                 Federal Register soliciting public
                                                  finalized, will represent the current                   as well as data and information                       comment on each proposed collection of
                                                  thinking of FDA on this topic. It does                  submitted by the sponsor.                             information before submitting the
                                                  not establish any rights for any person                    Based on our review of the sponsor’s               collection to OMB for approval. To
                                                  and is not binding on FDA or the public.                data and information, and other                       comply with this requirement, FDA will
                                                  You can use an alternate approach if it                 information available to the Agency                   publish a 60-day notice on the proposed
                                                  satisfies the requirements of the                       (e.g., FDA’s laboratory analyses                      collections of information in this draft
                                                  applicable statutes and regulations.                    establishing that AquAdvantage Salmon                 guidance in a future issue of the Federal
                                                     On November 19, 2015, FDA                            meets the criteria for Atlantic salmon                Register.
                                                  approved a new animal drug application                  established for the Regulatory Fish
                                                                                                                                                                IV. Electronic Access
                                                  (NADA) related to AquAdvantage                          Encyclopedia), we found that the
                                                  Salmon, a GE Atlantic salmon. This is                   composition, nutritional profile, and                    Persons with access to the Internet
                                                  FDA’s first approval of an NADA in                      safety of food from AquAdvantage                      may obtain the draft guidance at http://
                                                  support of a GE animal for use as food.                 Salmon do not differ from food from                   www.fda.gov/FoodGuidances or http://
                                                  According to information in the NADA,                   non-GE, farm-raised Atlantic salmon in                www.regulations.gov. Use the FDA Web
                                                  AquAdvantage Salmon is genetically                      any material way, and thus it is as safe              site listed in the previous sentence to
                                                  engineered to reach market size in a                    and nutritious as food from non-GE,                   find the most current version of the
                                                  shorter period than non-GE farm-raised                  farm-raised Atlantic salmon. For these                guidance.
                                                  Atlantic salmon. FDA’s Center for                       reasons, we concluded that there is no                  Dated: November 19, 2015.
                                                  Veterinary Medicine reviewed the                        basis to require additional labeling of               Leslie Kux,
                                                  NADA and made a determination                           food derived from AquAdvantage                        Associate Commissioner for Policy.
                                                  concerning the safety and effectiveness                 Salmon.2 3                                            [FR Doc. 2015–29904 Filed 11–23–15; 8:45 am]
                                                  of the new animal drug in                               II. Guidance on Voluntary Labeling                    BILLING CODE 4164–01–P
                                                  AquAdvantage Salmon.
                                                                                                             Recognizing that some consumers are
                                                     In terms of labeling of food derived
                                                                                                          interested in whether a food contains
                                                  from AquAdvantage Salmon, the law                                                                             DEPARTMENT OF HEALTH AND
                                                                                                          GE Atlantic salmon and some
                                                  requires, among other things, that the                                                                        HUMAN SERVICES
                                                                                                          manufacturers may want to respond to
                                                  label includes a name that accurately
                                                                                                          this consumer interest, we developed                  Food and Drug Administration
                                                  describes the basic nature of a food and
                                                                                                          this draft guidance to assist food
                                                  any other information that is considered                                                                      [Docket No. FDA–2000–D–0075]
                                                                                                          manufacturers that wish to voluntarily
                                                  material with regard to consequences
                                                                                                          label their food product or ingredients
                                                  that may result from the use of the food.                                                                     Voluntary Labeling Indicating Whether
                                                                                                          (for humans or animals) as either
                                                  In a 1992 policy on foods derived from                                                                        Foods Have or Have Not Been Derived
                                                  new plant varieties and a 2001 draft                      1 See
                                                                                                                                                                From Genetically Engineered Plants;
                                                                                                                  57 FR 22984, May 29, 1992.
                                                  guidance on voluntary labeling of food                    2 We note that, if a different GE salmon is
                                                                                                                                                                Guidance for Industry; Availability
                                                  from GE plants, we explained that:                      developed in the future, we will separately assess
                                                                                                                                                                AGENCY:   Food and Drug Administration,
                                                  Name changes are appropriate when a                     the data and information about that salmon to
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          determine whether it differs materially from non-GE   HHS.
                                                  food from a GE plant is materially
                                                  different from its traditional
                                                                                                          salmon and, as such, whether additional labeling      ACTION:   Notice of availability.
                                                                                                          would be required on food derived from that
                                                  counterpart, such that the common or                    salmon.                                               SUMMARY:  The Food and Drug
                                                  usual name no longer adequately                           3 Memorandum to File: Office of Nutrition,
                                                                                                                                                                Administration (FDA or we) is
                                                  describes the new food; or when there                   Labeling and Dietary Supplements, CFSAN:
                                                                                                          Evaluation of data and information and
                                                                                                                                                                announcing the availability of a
                                                  are other material differences that affect              recommendations related to the labeling of food       guidance for industry entitled
                                                  the food’s nutritional or functional                    from AquAdvantage Salmon.                             ‘‘Voluntary Labeling Indicating Whether


                                             VerDate Sep<11>2014   17:20 Nov 23, 2015   Jkt 238001   PO 00000   Frm 00033   Fmt 4703   Sfmt 4703   E:\FR\FM\24NON1.SGM   24NON1



Document Created: 2015-12-14 14:08:57
Document Modified: 2015-12-14 14:08:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 25, 2016.
ContactRegarding human food issues: Andrea Krause, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371. Regarding animal food issues: Kathleen Jones, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7077.
FR Citation80 FR 73193 

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