[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Pages 34142-34143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16136]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-051-1]


Availability of a Draft Environmental Assessment for Field 
Testing Avian Encephalomyelitis-Fowl Pox-Laryngotracheitis Vaccine, 
Live Virus, Fowl Pox Vector

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 a draft environmental assessment 
concerning authorization to ship for the purpose of field testing, and 
then to field test, an unlicensed avian encephalomyelitis-fowl pox-
laryngotracheitis 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 that we receive by July 27, 2001.

ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 01-051-1, Regulatory Analysis and 
Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238.
    Please state that your comment refers to Docket No. 01-051-1.
    Copies of the draft environmental assessment may be obtained by 
contacting the person listed under FOR

[[Page 34143]]

FURTHER INFORMATION CONTACT. Please refer to the docket number, date, 
and complete title of this notice when requesting copies. A copy of the 
draft 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, USDA, 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 safety of animals, public health, and the environment.
    Based on the risk analysis, APHIS has prepared a draft 
environmental assessment (EA) concerning the field testing of the 
combined unlicensed and licensed veterinary biological product:
    Requester: Biomune Company.
    Product: Avian Encephalomyelitis-Fowl Pox-Laryngotracheitis 
Vaccine, Live Virus, Fowl Pox Vector.
    Field test locations: Georgia, Kentucky, Nebraska, 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 fowl 
laryngotracheitis antigens. The vaccine is for use in chickens as an 
aid in the prevention of avian encephalomyelitis, fowl pox, and 
laryngotracheitis.
    The draft 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 final EA and finding of no 
significant impact (FONSI) 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 21st day of June 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-16136 Filed 6-26-01; 8:45 am]
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