[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.Greenberg@usda.gov.
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
