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Availability of an Environmental Assessment for Field Testing West Nile Virus Vaccine

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: January 28, 2003 (Volume 68, Number 18)]
[Notices]
[Page 4164-4165]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja03-34]

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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 03-003-1]
 
Availability of an Environmental Assessment for Field Testing 
West Nile Virus Vaccine

AGENCY: Animal and Plant Health Inspection Service, USDA
ACTION: Notice.

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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 West Nile Virus Vaccine for use in horses. 
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 licensure.

DATES: We will consider all comments that we receive on or before 
February 27, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 03-003-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 03-003-1. If you use e-mail, 
address your comment to regulations@aphis,usda.gov. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
03-003-1'' on the subject line.
    You may read the environmental assessment, the risk analysis (with 
confidential business information removed), and any comments that we 
receive 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

[[Page 4165]]

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.
    You may request a copy of the environmental assessment (as well as 
the risk analysis with confidential business information removed) by 
writing to Dr. Larry R. Ludemann, USDA, APHIS, VS, CVB-LPD, 510 South 
17th Street, Suite 104, Ames, IA 50010, or by calling (515) 232-5785. 
Please refer to the docket number, date and complete title of this of 
this notice when requesting copies.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html. Exit Disclaimer

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, Center for Veterinary Biologics, 
Licensing and Policy Development, VS, APHIS, USDA, 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, contact Dr. Larry R. Ludemann, USDA, APHIS, VS, CVB-LPD, 
510 South 17th Street, Suite 104, Ames, IA 50010; (515) 232-5785.

SUPPLEMENTARY INFORMATION: 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 unlicenced 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 unlicenced 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 
unlicenced veterinary biological product:
    Requester: Fort Dodge Animal Health, Inc.
    Product: West Nile Virus Vaccine, DNA Vaccine, Code 1995.D0.
    Field Test Locations: California, Kansas, Kentucky, Maryland, Ohio, 
and Oklahoma.
    The above-mentioned product is an Esherichia coli plasmid 
containing the prM and E genes of the West Nile virus. The vaccine is 
for use in horses as an aid in the prevention of viremia associated 
with West Nile 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 provision of NEPA (40 CFR parts 1500-1508), 
(3) USDA regulations implementing NEPA (7 CFR part 1b), 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 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 
licensure.

    Authority: 21 U.S.C. 151-159.

    Done in Washington, DC, this 22nd day of January, 2003.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-1864 Filed 1-27-03; 8:45 am]
BILLING CODE 3410-34-M

 
 

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