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###### Department of Agriculture

###### Animal and Plant Health Inspection Service 

          - [Docket No. 01-119-1] 

# AGENCY:

Animal and Plant Health Inspection Service, USDA. 

# ACTION:

Notice of availability and request for comments. 

# SUMMARY:

We are informing 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 avian encephalomyelitis-fowl pox-mycoplasma gallisepticum vaccine for use in poultry. 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 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 invite you to comment on this docket. We will consider all comments we receive that are postmarked, delivered, or e-mailed by January 28, 2002. 

# 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. 01-119-1, 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. 01-119-1. 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. 01-119-1” on the subject line. 

                        Copies of the environmental assessment may be obtained from the person listed under                         **FOR FURTHER INFORMATION CONTACT**                        . Please refer to the docket number, date, and complete title of this notice when requesting copies. A copy of the environmental assessment (as well as the risk analysis with confidential business information removed) and any comments that we receive on this docket are available for public inspection in our reading room. The reading room is located in room 1141 of the 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.                     

                        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.                     

# FOR FURTHER INFORMATION CONTACT: 

Dr. Albert P. Morgan, Chief Staff Officer, Operational Support Section, Center for Veterinary Biologics, Licensing and Policy Development, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; telephone (301) 734-8245, fax (301) 734-4314. 

# 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 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                           ( print page 67170)                        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 veterinary biological product: 

*Requester:*                     Biomune Company.                 

*Product:*                     Avian Encephalomyelitis-Fowl Pox-Mycoplasma Gallisepticum Vaccine, Live Virus, Fowl Pox Vector.                 

*Field test locations:*                     Iowa, Minnesota, Nebraska, North Carolina, Pennsylvania, Texas, and Virginia.                 

                    The above-mentioned product is a modified live avian encephalomyelitis vaccine in combination with a live, attenuated fowl pox virus that has been genetically modified to express                     *Mycoplasma gallisepticum*                     antigens. The vaccine is for use in chickens as an aid in the prevention of avian encephalomyelitis, fowl pox, and                     *Mycoplasma gallisepticum.*

                    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 environmental issues 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 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 the product meets all other requirements for licensure. 

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

Done in Washington, DC, this 20th day of December 2001. 

W. Ron Dehaven, 

Acting Administrator, Animal and Plant Health Inspection Service. 

[FR Doc. 01-31946 Filed 12-27-01; 8:45 am] 

BILLING CODE 3410-34-P