This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

54134 

Vol. 73, No. 182 

Thursday, September 18, 2008 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2008–0099] 

Availability of an Environmental 

Assessment for Field Testing Rabies 

Vaccine, Live Raccoon Poxvirus 

Vector 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has prepared an 

environmental assessment concerning 

authorization to ship for the purpose of 

field testing, and then to field test, an 

unlicensed Rabies Vaccine, Live 

Raccoon Poxvirus Vector. The 

environmental assessment, which is 

based on a risk analysis prepared to 

assess the risks associated with the field 

testing of this vaccine, examines the 

potential effects that field testing this 

veterinary vaccine could have on the 

quality of the human environment. 

Based on the risk analysis, we have 

reached a preliminary determination 

that field testing this veterinary vaccine 

will not have a significant impact on the 

quality of the human environment, and 

that an environmental impact statement 

need not be prepared. We intend to 

authorize shipment of this vaccine for 

field testing following the close of the 

comment period for this notice unless 

new substantial issues bearing on the 

effects of this action are brought to our 

attention. We also intend to issue a U.S. 

Veterinary Biological Product license for 

this vaccine, provided the field test data 

support the conclusions of the 

environmental assessment and the 

issuance of a finding of no significant 

impact and the product meets all other 

requirements for licensing. 

DATES: We will consider all comments 

that we receive on or before October 20, 

2008. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=APHIS2008-0099 to submit or view comments 

and to view supporting and related 

materials available electronically. 

• Postal Mail/Commercial Delivery: 

Please send two copies of your comment 

to Docket No. APHIS–2008–0099, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737–1238. Please state that your 

comment refers to Docket No. APHIS– 

2008–0099. 

Reading Room: You may read any 

comments that we receive on the 

environmental assessment in our 

reading room. The reading room is 

located in room 1141 of the USDA 

South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690–2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

http://www.aphis.usda.gov. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Albert P. Morgan, Section Leader, 

Operational Support Section, Center for 

Veterinary Biologics, Policy, Evaluation, 

and Licensing, VS, APHIS, 4700 River 

Road Unit 148, Riverdale, MD 20737– 

1231; phone (301) 734–8245, fax (301) 

734–4314. 

For information regarding the 

environmental assessment or the risk 

analysis, or to request a copy of the 

environmental assessment (as well as 

the risk analysis with confidential 

business information removed), contact 

Dr. Patricia L. Foley, Risk Manager, 

Center for Veterinary Biologics, Policy, 

Evaluation, and Licensing VS, APHIS, 

510 South 17th Street, Suite 104, Ames, 

IA 50010; phone (515) 232–5785, fax 

(515) 232–7120. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the Virus-Serum-Toxin Act (21 

U.S.C. 151 et seq.), a veterinary 

biological product must be shown to be 

pure, safe, potent, and efficacious before 

a veterinary biological product license 

may be issued. A field test is generally 

necessary to satisfy prelicensing 

requirements for veterinary biological 

products. Prior to conducting a field test 

on an unlicensed product, an applicant 

must obtain approval from the Animal 

and Plant Health Inspection Service 

(APHIS), as well as obtain APHIS’ 

authorization to ship the product for 

field testing. 

To determine whether to authorize 

shipment and grant approval for the 

field testing of the unlicensed product 

referenced in this notice, APHIS 

conducted a risk analysis to assess the 

potential effects of this product on the 

safety of animals, public health, and the 

environment. Based on the risk analysis, 

APHIS has prepared an environmental 

assessment (EA) concerning the field 

testing of the following unlicensed 

veterinary biological product: 

Requester: Fort Dodge Animal Health, 

Division of Wyeth Corporation. 

Product: Rabies Vaccine, Live 

Raccoon Poxvirus Vector. 

Field Test Locations: Iowa, Indiana, 

Texas, North Carolina, Oklahoma, 

Wisconsin, New York, Illinois, 

Minnesota, and Kansas. 

The above-mentioned product 

consists of a live recombinant raccoon 

poxvirus vector expressing rabies 

glycoprotein. The vaccine is for use in 

cats and dogs as an aid in the 

prevention of rabies virus infection. 

The EA has been prepared in 

accordance with: (1) The National 

Environmental Policy Act of 1969 

(NEPA), as amended (42 U.S.C. 4321 et 

seq. ), (2) regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

Unless substantial issues with adverse 

environmental impacts are raised in 

response to this notice, APHIS intends 

to issue a finding of no significant 

impact (FONSI) based on the EA and 

authorize shipment of the above product 

for the initiation of field tests following 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 182 / Thursday, September 18, 2008 / Notices 54135 

the close of the comment period for this 

notice. 

Because the issues raised by field 

testing and by issuance of a license are 

identical, APHIS has concluded that the 

EA that is generated for field testing 

would also be applicable to the 

proposed licensing action. Provided that 

the field test data support the 

conclusions of the original EA and the 

issuance of a FONSI, APHIS does not 

intend to issue a separate EA and FONSI 

to support the issuance of the product 

license, and would determine that an 

environmental impact statement need 

not be prepared. APHIS intends to issue 

a veterinary biological product license 

for this vaccine following completion of 

the field test provided no adverse 

impacts on the human environment are 

identified and provided the product 

meets all other requirements for 

licensing. 

Authority: 21 U.S.C. 151–159. 

Done in Washington, DC, this 12th day of 

September 2008. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E8–21820 Filed 9–17–08; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2008–0019] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

Nutrition and Foods for Special Dietary 

Uses 

AGENCY: Office of the Under Secretary 

for Food Safety, USDA. 

ACTION: Notice of public meeting and 

request for comments. 

SUMMARY: The Office of the Under 

Secretary for Food Safety, U.S. 

Department of Agriculture (USDA), and 

the Food and Drug Administration 

(FDA), U.S. Department of Health and 

Human Services (HHS), are sponsoring 

a public meeting on September 24, 

2008. The objective of the public 

meeting is to provide information and 

receive public comments on agenda 

items and draft United States positions 

that will be discussed at the 30th 

Session of the Codex Committee on 

Nutrition and Foods for Special Dietary 

Uses (CCNFSDU) of the Codex 

Alimentarius Commission (Codex), 

which will be held in Capetown, South 

Africa, on November 3–November 7, 

2008. In addition, a working group will 

meet on November 1, 2008, to discuss 

agenda items on the Scientific Basis of 

Health Claims and Nutrient Reference 

Values for food labeling purposes, and 

any other matters related to the World 

Health Organization’s (WHO) Global 

Strategy on Diet, Physical Activity and 

Health which are under consideration 

by the CCNFSDU. The Under Secretary 

for Food Safety and FDA recognize the 

importance of providing interested 

parties the opportunity to obtain 

background information on the 30th 

Session of CCNFSDU and to address 

items on the agenda. 

DATES: The public meeting is scheduled 

for Wednesday, September 24, 2008, 

from 1 p.m. to 4 p.m. 

ADDRESSES: The public meeting will be 

held in the Auditorium (1A003), Food 

and Drug Administration, Harvey Wiley 

Federal Building, 5100 Paint Branch 

Parkway, College Park, MD 20740. 

Parking is adjacent to this building and 

will be available at no charge to 

individuals who pre-register by the date 

below (See Pre-Registration). In 

addition, the College Park metro station 

is across the street. Codex documents 

related to the 30th Session of the 

CCNFSDU will be accessible via the 

World Wide Web at the following 

address: http:// 

www.codexalimentarius.net/ 

current.asp. 

Pre-Registration: To gain admittance 

to this meeting, individuals must 

present a photo ID for identification and 

also are required to pre-register. In 

addition, no cameras or videotaping 

equipment will be permitted in the 

meeting room. To pre-register, please 

send the following information to e-mail 

address nancy.crane@fda.hhs.gov by 

September 17, 2008: 

—Your Name 

—Organization 

—Mailing Address 

—Phone number 

—E-mail address 

FOR FURTHER INFORMATION ABOUT THE

30TH SESSION OF THE CCNFSDU CONTACT: 

Nancy Crane, Assistant to the U.S. 

Delegate to the CCNFSDU, Office of 

Nutrition, Labeling and Dietary 

Supplements, Center for Food Safety 

and Applied Nutrition, FDA, 5100 Paint 

Branch Parkway (HFS–830), College 

Park, MD 20740, Phone: (301) 436–1450, 

Fax: (301) 436–2636, E-mail: 

nancy.crane@fda.hhs.gov. 

FOR FURTHER INFORMATION ABOUT THE

PUBLIC MEETING CONTACT: Edith 

Kennard, Staff Officer, U.S. Codex 

Office, Food Safety and Inspection 

Service (FSIS), Room 4861, South 

Building, 1400 Independence Avenue, 

SW., Washington, DC 20250, Phone: 

(202) 720–5261, Fax: (202) 720–3157, Email: edith.kennard@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Codex Alimentarius (Codex) was 

established in 1963 by two United 

Nations organizations, the Food and 

Agriculture Organization and the WHO. 

Through adoption of food standards, 

codes of practice, and other guidelines 

developed by its committees, and by 

promoting their adoption and 

implementation by governments, Codex 

seeks to protect the health of consumers 

and ensure that fair practices are used 

in trade. 

The CCNFSDU was established to 

study specific nutritional problems 

assigned to it by the Commission and 

advise the Commission on general 

nutritional issues; to draft general 

provisions as appropriate concerning 

the nutritional aspects of all foods; to 

develop standards, guidelines, or related 

texts for foods for special dietary uses in 

cooperation with other committees 

when necessary; and to consider, amend 

if necessary, and endorse provisions on 

nutritional aspects proposed for 

inclusion in Codex standards, 

guidelines, and related texts. The 

Committee is hosted by the Federal 

Republic of Germany. 

Issues To Be Discussed at the Public 

Meeting 

The following items on the agenda for 

the 30th Session of the CCNFSDU will 

be discussed during the public meeting: 

• Matters Referred to the Committee 

from Other Codex Bodies (including the 

Global Strategy on Diet, Physical 

Activity and Health and Infant Formula 

Methods of Analysis); 

• Guidelines for Use of Nutrition 

Claims: Draft Table of Conditions for 

Nutrient Contents: Part B, Containing 

Provisions on Dietary Fibre 

• Draft Advisory List of Nutrient 

Compounds for Use in Foods for Special 

Dietary Uses for Infants and Young 

Children: Part D Advisory List of Food 

Additives for Special Nutrient Forms: 

Provisions on Gum Arabic; 

• Draft Nutritional Risk Analysis 

Principles and Guidelines for 

Application to the Work of the 

Committee on Nutrition and Foods for 

Special Dietary Uses; 

• Proposed Draft Recommendations 

on the Scientific Basis of Health Claims; 

• Proposal for New Work to Amend 

the Codex General Principles for the 

Addition of Essential Nutrients to 

Foods; 

• Proposal for New Work to Establish 

a Standard for Processed Cereal-Based 


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