Notice: Availability of an Environmental Assessment for Field Testing 
Rabies Vaccine, Live Raccoon Poxvirus Vector

Federal Register: September 18, 2008 (Volume 73, Number 182)         
                  Page 54134-54135

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=APHIS-2008-0099 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

[[Page 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