
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Notices]
[Pages 73193-73194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29904]


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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Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for 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.

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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availability of a draft guidance for industry entitled ``Voluntary 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developed the draft guidance to assist food manufacturers that wish to 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10.115(g)(5)), to ensure that FDA considers your comment on the draft 
guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 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.
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    \1\ See 57 FR 22984, May 29, 1992.
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    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
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    \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.
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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


