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- Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry; Availability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 Range		73193-73194
FR Document		2015-29904

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon: Guidance for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 We developed the draft guidance to assist food manufacturers that wish to voluntarily label their food product or ingredients (for humans or animals) derived from Atlantic salmon as either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

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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Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for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availability of a draft guidance for industry entitled ``Voluntary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developed the draft guidance to assist food manufacturers that wish to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10.115(g)(5)), to ensure that FDA considers your comment on the draft
guidance before it begins work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by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

Document Created: 2015-12-14 14:08:57
Document Modified: 2015-12-14 14:08:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		80 FR 73193

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration