[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Notices]
[Pages 27232-27233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12576]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 99-034-1]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Testing Marek's Disease--Newcastle Disease 
Vaccine, Serotypes 1 and 3, Live Marek's Disease Virus 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 an environmental assessment and finding 
of no significant impact concerning authorization to ship for the 
purpose of field testing, and then to field test, an unlicensed live 
viral vaccine to protect poultry from Marek's disease and Newcastle 
disease. A risk analysis, which forms the basis for the environmental 
assessment, has led us to conclude that field testing this veterinary 
vaccine will not have a significant impact on the quality of the human 
environment. Based on our finding of no significant impact, we have 
determined that an environmental impact statement need not be prepared. 
We intend to authorize shipment of this vaccine for field testing 14 
days after the date of 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 finding of no significant impact and the 
product meets all other requirements for licensure.

ADDRESSES: Copies of the environmental assessment and finding of no 
significant impact may be obtained by contacting the person listed 
under FOR FURTHER INFORMATION CONTACT. Please refer to the docket 
number, date, and complete title of this notice when requesting copies. 
Copies of the environmental assessment and finding of no significant 
impact (as well as the risk analysis with confidential business 
information removed) are available for public inspection at USDA, room 
1141, South

[[Page 27233]]

Building, 14th Street and Independence Avenue SW., Washington, DC, 
between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. 
Persons wishing to inspect those documents are requested to call ahead 
on (202) 690-2817 to facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Jeanette Greenberg, Technical 
Writer-Editor, Center for Veterinary Biologics, Licensing and Policy 
Development, VS, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 
20737-1231; telephone: (301) 734-5338; fax: (301) 734-4314; or e-mail: 
Jeanette.B.G[email protected].

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.

    In determining 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). APHIS has concluded that field testing the unlicensed 
veterinary biological product will not significantly affect the quality 
of the human environment. Based on this finding of no significant 
impact (FONSI), we have determined that there is no need to prepare an 
environmental impact statement.

    An EA and FONSI have been prepared by APHIS concerning the field 
testing of the following unlicensed veterinary biological product:

    Requester: Tri Bio Laboratories, Inc.

    Product: Marek's Disease-Newcastle Disease Vaccine, Serotypes 1 and 
3, Live Marek's Disease Virus Vector.

    Field test locations: Wisconsin, North Carolina, and California.

    The above-mentioned vaccine is for use as an aid in the prevention 
of Marek's disease and Newcastle disease in chickens. In this vaccine, 
the live vector is Marek's disease serotype 3 virus, also known as 
turkey herpesvirus, a nonpathogenic virus in widespread use as a 
poultry vaccine since 1972. Genetic engineering procedures were used to 
insert into the vector virus two genes from Marek's disease serotype 1 
virus and two genes from the Newcastle disease virus.

    The EA and FONSI have 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 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 authorize shipment of the above product 
for the initiation of field tests 14 days from the date of this notice.

    Because the issues raised by field testing and by issuance of a 
license are identical, APHIS has concluded that the EA and FONSI that 
were 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 FONSI, APHIS does not intend to 
issue a separate EA 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 13th day of May 1999.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-12576 Filed 5-18-99; 8:45 am]
BILLING CODE 3410-34-P