
[Federal Register: August 26, 2010 (Volume 75, Number 165)]
[Notices]               
[Page 52601-52605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au10-124]                         


[[Page 52601]]

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

Part II





Department of Health and Human Services





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



Food and Drug Administration



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



Food Labeling; Labeling of Food Made From AquAdvantage Salmon; Public 
Hearing; Request for Comments; Veterinary Medicine Advisory Committee; 
Notice of Meeting; Notices


[[Page 52602]]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0385]

 
Food Labeling; Labeling of Food Made From AquAdvantage Salmon; 
Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing regarding the labeling of food derived from AquAdvantage 
Salmon, a genetically engineered Atlantic salmon. The purpose of the 
hearing is for FDA to explain the relevant legal principles for food 
labeling and to solicit information and views from interested persons 
on the application of these principles to the labeling of food derived 
from AquAdvantage Salmon. In a separate notice published elsewhere in 
this issue of the Federal Register, FDA is announcing that it will hold 
a public Veterinary Medicine Advisory Committee (VMAC) meeting.

DATES: See ``How to Participate in the Hearing'' in the SUPPLEMENTARY 
INFORMATION section of this document.

ADDRESSES: See ``How to Participate in the Hearing'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:
    For questions about registration, to register orally, or to submit 
a notice of participation by mail, fax, or by e-mail: Syreeta Jones, BL 
Seamon Corporation, 9001 Edmonston Road, Suite 200, Greenbelt, MD 
20770, phone: 301-577-0244 ext. 4900, fax: 301-577-5261, e-mail: 
sjones@blseamon.com.
    For questions about the hearing, if you need special accommodations 
due to a disability, or to submit the full text, comprehensive outline 
or summary of an oral presentation: Juanita Yates, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-1731, e-mail: 
Juanita.Yates@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In a separate notice published elsewhere in this issue of the 
Federal Register, FDA is announcing that it will hold a public VMAC 
meeting. The VMAC will consider issues regarding the safety and 
effectiveness of the new animal drug that is the subject of the new 
animal drug application (NADA) concerning AquAdvantage Salmon produced 
by AquaBounty Technologies, Inc. In the event that the NADA relating to 
AquAvantage salmon is approved, public input from this hearing on the 
labeling of food from AquAdvantage Salmon will assist FDA in the 
application of its food labeling principles which will determine if we 
should require labeling for such food beyond that required for food 
from other varieties of Atlantic salmon. A background document 
entitled, ``Background Document: Public Hearing on the Labeling of Food 
Made from the AquAdvantage Salmon'' describing the relevant legal 
principles and related questions specific to the labeling of foods from 
AquAdvantage Salmon is available at: http://www.fda.gov/Food/
LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/Topic-
SpecificLabelingInformation/default.htm. In addition to this background 
document, approximately 2 weeks (but no later than 2 business days) 
prior to the hearing, specific technical information on the 
AquAdvantage Salmon will be posted on FDA's Web site at: http://
www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/ucm201810.htm.
    The following are five key principles for labeling foods that are 
applicable to the specific issue of the labeling of foods from 
genetically engineered animals, such as the AquAdvantage Salmon:
    1. The law prohibits food labeling that is false (Section 403(a)(1) 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
343(a)(1)));
    2. The law prohibits food labeling that is misleading, particularly 
in light of material facts about the product (Sections 403(a)(1) and 
201(n) of the act (21 U.S.C. 343(a)(1) and 321(n)))\1\;
---------------------------------------------------------------------------

    \1\ Section 201(n) of the act (21 U.S.C. 321(n) provides 
information on how labeling can be misleading. It states that 
labeling is misleading if it fails to reveal facts that are (1) 
material in light of representations made or suggested in the 
labeling, or (2) material with respect to consequences that may 
result from the use of the food to which the labeling or advertising 
relates under the conditions of use prescribed in the labeling or 
under such conditions of use as are customary or usual.
---------------------------------------------------------------------------

    3. The law allows voluntary labeling about production methods, so 
long as the labeling is not false or misleading;
    4. The law requires that the label include a name that accurately 
describes the basic nature of the food (Section 403(i) of the act (21 
U.S.C. 343(i))); and
    5. FDA cannot require additional labeling about production methods 
unless it is necessary to ensure that the labeling is not false or 
misleading (See e.g., 72 FR 16291 at 16294, April 4, 2007). Another way 
of stating this point is that FDA cannot require labeling based on 
differences in the production process if the resulting products are not 
materially different due solely to the production process.

II. Purpose and Scope of the Hearing

    The purpose of the hearing is for FDA to explain the relevant legal 
principles for food labeling and to solicit information and views from 
interested persons on the application of this framework to the labeling 
of food derived from AquAdvantage Salmon. The scope of this hearing is 
determined by this notice. We invite information and comments on the 
issues and questions listed in section III of this document as follows.

III. Issue for Discussion

    At this hearing, FDA will seek public comment on the application of 
the principles of food labeling to food from the AquAdvantage Salmon. 
To facilitate public comment, specific technical information about the 
AquAdvantage Salmon will be posted on the FDA website approximately 2 
weeks (but no later than 2 business days) prior to the public hearing.
    At the public hearing, FDA will be inviting the public to share its 
views on:
    1. Which facts about the AquAdvantage Salmon seem most pertinent 
for FDA's consideration of whether there are any ``material'' 
differences between foods from this salmon and foods from other 
Atlantic salmon. (Keep in mind that the use of genetic engineering does 
not, in and of itself, constitute a ``material'' difference under the 
law.)
    2. If FDA determined there are ``material'' differences, how would 
that difference be described on a food label in a way that is truthful 
and non-misleading. (Keep in mind that it is the difference in 
composition, or in functional, organoleptic or other material 
properties that must be described, not the underlying production 
process.)
    Information about changes in the attributes of the food itself, 
such as its nutritional value, functional properties (e.g., storage), 
and ``organoleptic'' qualities (e.g., texture and aroma) could be 
material (see e.g., 72 FR 16291 at 16293, April 4, 2007). When 
commenting on these issues, FDA requests that respondents include 
support for their answers with relevant data, where appropriate, and/or 
references to the relevant legal principles.

[[Page 52603]]

IV. Notice of Hearing Under 21 CFR Part 15

    Because this is the first time the Agency is considering an 
application for a genetically engineered animal intended for use as 
food, at this hearing FDA invites the public to share its views on the 
application of the relevant legal principles of food labeling to food 
from the AquAdvantage Salmon. By delegation from the Commissioner of 
Food and Drugs (the Commissioner) (Staff Manual Guide 1410.21, section 
1(G)(5)), the Assistant Commissioner for Policy finds that because this 
is the first time the Agency is considering such an application, it is 
in the public interest to permit persons to present information and 
views at a public hearing regarding the labeling of food made from 
AquAdvantage Salmon, and is announcing that the public hearing will be 
held in accordance with part 15 (21 CFR part 15). The presiding officer 
will be the Commissioner or her designee. The presiding officer will be 
accompanied by a panel of FDA employees with relevant expertise.
    Persons who wish to participate in the hearing (either by making an 
oral presentation or as a member of the audience) must file a notice of 
participation (see Table 1, FOR FURTHER INFORMATION CONTACT, and ``How 
to Participate in the Hearing'' in section V of this document). By 
delegation from the Commissioner (Staff Manual Guide 1410.21, section 
1(G)(5)), the Assistant Commissioner for Policy has determined under 
Sec.  15.20(c) that advance submissions of oral presentations are 
necessary for the panel to formulate useful questions to be posed at 
the hearing under Sec.  15.30(e), and that the submission of a 
comprehensive outline or summary is an acceptable alternative to the 
submission of the full text of the oral presentation. We request that 
individuals and organizations with common interests consolidate their 
requests for oral presentations and request time for a joint 
presentation through a single representative. After reviewing the 
notices of participation and accompanying information, we will schedule 
each oral presentation and notify each participant of the time allotted 
to the presenter and the approximate time that the presentation is 
scheduled to begin. If time permits, we may allow interested persons 
who attend the hearing but did not submit a notice of participation in 
advance to make an oral presentation at the conclusion of the hearing. 
The hearing schedule will be available at the hearing.
    After the hearing, we will place the hearing schedule and a list of 
participants on file in the Division of Dockets Management (see Table 
1) under the docket number listed in brackets in the heading of this 
notice.
    To ensure timely handling of any mailed notices of participation, 
presentations, or comments, any outer envelope should be clearly marked 
with the docket number listed in brackets in the heading of this notice 
along with the statement ``Food Labeling; Labeling of Food Made From 
AquAdvantage Salmon; Public Hearing; Request for Comments.''
    Under Sec.  15.30(f), the hearing is informal, and the rules of 
evidence do not apply. No participant may interrupt the presentation of 
another participant. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to our policy and 
procedures for electronic media coverage of our public administrative 
proceedings in part 10, subpart C (21 CFR part 10, subpart C). Under 
Sec.  10.205, representatives of the electronic media may be permitted, 
subject to the procedures and limitations in Sec.  10.206, to 
videotape, film, or otherwise record our public administrative 
proceedings, including presentations by participants. The hearing will 
be transcribed as stipulated in Sec.  15.30(b).
    Any persons requiring special accommodations to attend the hearing 
due to a disability, should direct those needs to the contact person 
(see FOR FURTHER INFORMATION CONTACT).
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of these provisions as specified in Sec. Sec.  
10.19 and 15.30(h). In particular, Sec.  15.21(a) states that the 
notice of hearing will provide persons an opportunity to file a written 
notice of participation with the Division of Dockets Management within 
a specified period of time. If the public interest requires, e.g., if a 
hearing is to be conducted within a short period of time, the notice 
may name a specific FDA employee and telephone number to whom an oral 
notice of participation may be given. If the public interest requires, 
the notice may also provide for submitting notices of participation at 
the time of the hearing. In this document, the conditions for the 
hearing specify that notices of participation be submitted 
electronically to an agency Internet site, to a contact person (outside 
of FDA) who will accept notices of participation by mail, telephone, 
fax, or e-mail, or in person on the day of the hearing (as space 
permits). We are using these procedures for submitting notices of 
participation, rather than provide for the submission of notices of 
participation to the Division of Dockets Management, because the 
hearing is to be conducted within a short period of time and these 
procedures are more efficient. In addition, these procedures provide 
more flexibility to persons who wish to participate in the hearing than 
would be provided if participants were required to submit the notice of 
participation in writing to the Division of Dockets Management. By 
delegation from the Commissioner (Staff Manual Guide 1410.21, section 
1(G)(5)), the Assistant Commissioner for Policy finds under Sec.  10.19 
that no participant will be prejudiced, the ends of justice will 
thereby be served, and the action is in accordance with law if notices 
of participation are submitted by the procedures listed in this notice 
rather than to the Division of Dockets Management.

V. How to Participate in the Hearing

    Advance registration by submission of a notice of participation is 
necessary to ensure participation and will be accepted on a first-come, 
first-served basis. You may submit the notice of participation 
electronically (see Table 1); we encourage you to use this electronic 
means of advance registration. You also may submit the notice of 
participation orally or by mail, fax, or e-mail (see FOR FURTHER 
INFORMATION CONTACT). See Table 1 for the dates by which you must 
submit your notice of participation. A single copy of any notice of 
participation is sufficient.

[[Page 52604]]



                Table 1.--Information on Participation in the Hearing and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
                                                                   Address  (Non-
                            Date          Electronic Address         electronic)           Other Information
----------------------------------------------------------------------------------------------------------------
Date of Hearing      September 21,      ......................  Hilton Hotel and      ..........................
                      2010, from 9                               Executive Meeting
                      a.m. to 4:30                               Center, 1750
                      p.m.                                       Rockville Pike,
                                                                 Rockville, MD
                                                                 20850, 301-468-1100
----------------------------------------------------------------------------------------------------------------
Advance              By September 13,   http://                 We encourage you to   Registration to attend the
 Registration         2010               www.fedmeetings.net/    use electronic        hearing will also be
                                         common/                 registration if       accepted onsite on the
                                         registration.cfm?mid=   possible.             day of the hearing, as
                                         3210                                          space permits. Requests
                                                                                       made on the day of the
                                                                                       hearing to make an oral
                                                                                       presentation may be
                                                                                       granted as time permits.
                                                                                       Registration information
                                                                                       and information on
                                                                                       requests to make an oral
                                                                                       presentation may be
                                                                                       posted without change to
                                                                                       http://
                                                                                       www.regulations.gov,
                                                                                       including any personal
                                                                                       information provided.
---------------------------------------
Make a request for   By September 8,    ......................  ....................  ..........................
 oral presentation    2010
----------------------------------------------------------------------------------------------------------------
Provide a brief      By September 13,   ......................  Juanita Yates (See    Written material
 description of the   2010                                       FOR FURTHER           associated with an oral
 oral presentation                                               INFORMATION           presentation may be
 and any written                                                 CONTACT)              posted without change to
 material for the                                                                      http://
 presentation                                                                          www.regulations.gov,
                                                                                       including any personal
                                                                                       information provided.
----------------------------------------------------------------------------------------------------------------
Request special      By September 13,   ......................  Juanita Yates (See    ..........................
 accommodations due   2010                                       FOR FURTHER
 to a disability                                                 INFORMATION
                                                                 CONTACT)
----------------------------------------------------------------------------------------------------------------
Submit comments      By November 22,    Federal eRulemaking     FAX: 301-827-6870     All comments must include
                      2010               Portal: http://         Mail/Hand delivery/   the agency name and the
                                         www.regulations.gov.    Courier (for paper,   docket number found in
                                         Follow the              disk, or CD-ROM       brackets in the heading
                                         instructions for        submissions):         of this document. All
                                         submitting comments.    Division of Dockets   comments received may be
                                                                 Management (HFA-      posted without change to
                                                                 305), Food and Drug   http://
                                                                 Administration,       www.regulations.gov,
                                                                 5630 Fishers Lane     including any personal
                                                                 rm. 1061,             information provided. We
                                                                 Rockville, MD 20852   encourage you to continue
                                                                                       to submit electronic
                                                                                       comments by using the
                                                                                       Federal eRulemaking
                                                                                       Portal. For additional
                                                                                       information on submitting
                                                                                       comments, see the
                                                                                       ``Comments'' heading of
                                                                                       the SUPPLEMENTARY
                                                                                       INFORMATION section of
                                                                                       this document.
----------------------------------------------------------------------------------------------------------------
\*\ You may also register or request to make an oral presentation by mail, fax, e-mail, or phone by providing
  registration information (including name, title, business affiliation (if applicable), address, telephone
  number, fax number (if available), and e-mail address (if available)) (see FOR FURTHER INFORMATION CONTACT).

    The notice of participation must include your name, title, business 
affiliation (if applicable), address, telephone number, fax number (if 
available), and e-mail address (if available). If you wish to request 
an opportunity to make an oral presentation during the open public 
comment period of the hearing, your notice of participation also must 
include the title of your presentation, the sponsor of the oral 
presentation (e.g., the organization paying travel expenses or fees), 
if any; and the approximate amount of time requested for the 
presentation. Presentations must be limited to the questions and 
subject matter identified in section III of this document.
    Under Sec.  15.20(c), if you request an opportunity to make an oral 
presentation you must submit your presentation (either as the full text 
of the presentation, or as a comprehensive outline or summary). You may 
do so by e-mail or in writing. See Table 1 for the dates by which you 
must submit your presentation. See Table 1 and FOR FURTHER INFORMATION 
CONTACT for information on where to send your presentation.
    Individuals who request an opportunity to make an oral presentation 
will be notified of the scheduled time for their presentation prior to 
the hearing. Depending on the

[[Page 52605]]

number of oral presentations, we may need to limit the time allotted 
for each oral presentation (e.g., 5 minutes each). Depending on the 
content of the presentations, the time allotted for oral presentations 
may vary. We request that interested persons and groups having similar 
interests consolidate their requests for oral presentation and present 
them through a single representative. If you need special 
accommodations due to a disability, please inform us (see Table 1 and 
FOR FURTHER INFORMATION CONTACT).
    We will also accept registration onsite; however, space is limited. 
Onsite registration will be accepted on a first-come, first-served 
basis and will be closed when the maximum seating capacity is reached. 
Requests for an opportunity to make a presentation from individuals or 
organizations that did not register in advance to make an oral 
presentation may be granted if time permits.
    Persons who registered in advance for the hearing should check in 
at the onsite registration desk between 8:30 and 9 a.m. Persons who 
wish to register onsite on the day of the hearing should do so at the 
registration desk between 8:30 and 9 a.m. We encourage all participants 
to attend the entire day.

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see Table 1) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

VII. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: August 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21243 Filed 8-25-10; 8:45 am]
BILLING CODE 4160-01-S

