52602 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 

1Section 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. 

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/FoodLabeling

GuidanceRegulatoryInformation/TopicSpecificLabelingInformation/

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/Committees

MeetingMaterials/VeterinaryMedicine

AdvisoryCommittee/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; 

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 nonmisleading. (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. 

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Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 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 § 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 § 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 § 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 § 10.205, representatives of the 

electronic media may be permitted, 

subject to the procedures and 

limitations in § 10.206, to videotape, 

film, or otherwise record our public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 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 §§ 10.19 

and 15.30(h). In particular, § 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 

§ 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. 

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52604 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 

TABLE 1.—INFORMATION ON PARTICIPATION IN THE HEARING AND ON SUBMITTING COMMENTS

Date Electronic Address Address 

(Non-electronic) Other Information 

Date of Hearing September 21, 

2010, from 9 a.m. 

to 4:30 p.m. 

Hilton Hotel and Executive Meeting Center, 

1750 Rockville Pike, 

Rockville, MD 20850, 

301–468–1100 

Advance Registration By September 13, 

2010 

http://www.fedmeetings.net/

common/registration.

cfm?mid=3210 

We encourage you to use 

electronic registration if 

possible. 

Registration to attend the hearing 

will also be accepted onsite on 

the day of the hearing, as 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 oral 

presentation 

By September 8, 

2010 

Provide a brief description of the oral presentation and any written material for the 

presentation 

By September 13, 

2010 

Juanita Yates (See FOR 

FURTHER INFORMATION CONTACT) 

Written material associated with an 

oral presentation may be posted 

without change to http:// 

www.regulations.gov, including 

any personal information provided. 

Request special accommodations due to a 

disability 

By September 13, 

2010 

Juanita Yates (See FOR 

FURTHER INFORMATION CONTACT) 

Submit comments By November 22, 

2010 

Federal eRulemaking Portal: 

http:// 

www.regulations.gov. Follow the instructions for 

submitting comments. 

FAX: 301–827–6870 Mail/ 

Hand delivery/Courier 

(for paper, disk, or CD– 

ROM submissions): Division of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 Fishers 

Lane rm. 1061, Rockville, MD 20852 

All comments must include the 

agency name and the docket 

number found in brackets in the 

heading of this document. All 

comments received may be posted without change to http:// 

www.regulations.gov, including 

any personal information provided. We 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 § 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 

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Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 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 firstcome, 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Veterinary Medicine Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Veterinary 

Medicine Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on September 19, 2010, from 1 

p.m. to 5:30 p.m. and on September 20, 

2010, from 8 a.m. until 6 p.m. 

Location: Rockville Hilton, 1750 

Rockville Pike, Rockville, MD 20852, 

301–468–1100. 

Contact Person: Aleta Sindelar, Center 

for Veterinary Medicine (HFV–3), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–276– 

9004, FAX: 240–276–9020, email: 

aleta.sindelar@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512548. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the Agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On September 19, 2010, the 

committee will receive an orientation on 

both general scientific issues 

surrounding genetically engineered 

animals and the statutory and regulatory 

constraints under which the Agency 

must operate. On September 20, 2010, 

the committee will consider issues 

regarding the safety and effectiveness of 

the new animal drug that is the subject 

of a new animal drug application 

(NADA) concerning AquAdvantage 

salmon produced by AquaBounty 

Technologies, Inc. These genetically 

engineered Atlantic salmon are 

intended to grow faster than 

conventionally bred Atlantic salmon. 

Two background documents entitled 

‘‘An overview of Atlantic salmon, its 

natural history, aquaculture, and genetic 

engineering’’ and ‘‘The VMAC Meeting 

on Science-Based Issues Associated 

with AquAdvantage Salmon’’ can be 

found at http://www.fda.gov/Advisory

Committees/CommitteesMeeting

Materials/VeterinaryMedicine

AdvisoryCommittee/ucm201810.htm. 

In a separate notice published 

elsewhere in this issue of the Federal 

Register, FDA is announcing that it will 

hold a public hearing on the labeling of 

food, including naming of the food, 

from the AquAdvantage salmon on 

September 21, 2010. This public hearing 

will allow the public to comment on the 

application of food labeling principles 

to food from the AquAdvantage Salmon, 

if the NADA is approved. An overview 

of the labeling issues to be addressed is 

described in ‘‘Background Document: 

Public Hearing before the Commissioner 

on the Labeling of Food Made from the 

AquAdvantage Salmon’’ at http:// 

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Veterinary

MedicineAdvisoryCommittee/ 

ucm201810.htm. 

FDA anticipates making the meeting 

materials available approximately 16 

days before this meeting, but in any 

event no later than 2 business days 

before the meeting at http:// 

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Veterinary

MedicineAdvisoryCommittee/ 

ucm201810.htm. If FDA is unable to 

post the background material on its Web 

site prior to the meeting, the background 

material will be made publicly available 

at the location of the advisory 

committee meeting, and the background 

material will be posted on FDA’s Web 

site after the meeting. 

Additional information regarding the 

Center for Veterinary Medicine’s 

(CVM’s) regulatory oversight of 

genetically engineered animals can be 

found at http://www.fda.gov/ 

AnimalVeterinary/Development

ApprovalProcess/GeneticEngineering/ 

GeneticallyEngineeredAnimals/ 

default.htm. 

Please be advised that as soon as a 

transcript is available, it can be obtained 

in either hardcopy or on CD–ROM, after 

submission of a Freedom of Information 

request. Written requests are to be sent 

to the Division of Freedom of 

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