[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37010-37011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18107]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-055-1]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Testing Vaccine Containing Canarypox-
Vectored Rabies Fraction

AGENCY: Animal and Plant Health Inspection Service, USDA.


[[Page 37011]]


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 a 
finding of no significant impact for the shipment for field testing of 
an unlicensed veterinary vaccine containing a canarypox-vectored rabies 
fraction for use in cats. A risk analysis, which forms the basis for 
the environmental assessment, has led us to conclude that shipment of 
this veterinary vaccine for field testing 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. With this notice, we state our 
intention to authorize shipment of this combination vaccine product for 
field testing 14 days after the date of this notice, unless new 
substantial issues bearing on the effects of the action contemplated 
here are brought to our attention. We also intend to issue a veterinary 
biological product license for this product and three additional 
products containing the same canarypox-vectored rabies fraction, 
provided the field trial data support the conclusions of the 
environmental assessment and finding of no significant impact and the 
products meet 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 also available for public inspection at USDA, 
room 1141, South 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, Veterinary Services, APHIS, USDA, 4700 River Road Unit 
148, Riverdale, MD 20737-1231; telephone (301) 734-8400; fax (301) 734-
8910; or e-mail: [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. In order 
to ship an unlicensed veterinary biological product for the purpose of 
conducting a field test, a person must receive authorization from the 
Animal and Plant Health Inspection Service (APHIS).
    In determining whether to authorize shipment for field testing of 
the unlicensed veterinary biological product referenced in this notice, 
APHIS conducted a risk analysis to assess the potential effect of this 
product on the safety of animals, the public health, and the 
environment. Based on the risk analysis, APHIS has prepared an 
environmental assessment (EA). APHIS has concluded that shipment of the 
unlicensed veterinary biological product for field testing 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 for the shipment of the following 
unlicensed veterinary biological product for field testing:
    Requester: Rhone Merieux, Inc., Establishment License No. 298.
    Product: Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia-
Chlamydia Psittaci-Rabies Vaccine, Modified Live and Killed Virus and 
Chlamydia, Canarypox Vector (Code 16A9.R0).
    Field test locations: California, Florida, Georgia, Illinois, New 
York, Pennsylvania, Texas, and Wisconsin.
    The EA and FONSI have been prepared in accordance with: (1) The 
National Environmental Policy Act of 1969, as amended (NEPA) (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 the shipment of the above 
product and the initiation of the field tests after 14 days from the 
date of this notice.
    Because the issues raised by authorization of a field trial and by 
issuance of a license are identical, APHIS has concluded that the EA 
and FONSI that were generated for the field trial would also be 
applicable to the proposed licensing action. Provided that the field 
trial data support the conclusions of the original EA and FONSI, APHIS 
does not intend to generate a separate EA to support the issuance of 
the product license, and would determine that an environmental impact 
statement need not be prepared. Therefore, APHIS intends to issue a 
veterinary biological product license for this product following the 
completion of the field trial, provided no adverse impacts on the human 
environment are identified as a result of field testing this product 
and provided the product meets all other requirements for licensure.
    Simultaneously, APHIS intends to issue licenses for three 
additional combination vaccines produced by Rhone Merieux, Inc., also 
for use in cats. These three vaccines (each of which contains the same 
canarypox-vectored rabies fraction but lacks one or two components 
present in the above-mentioned product) are as follows:
    Product: Feline Rhinotracheitis-Calici-Panleukopenia-Chlamydia 
Psittaci-Rabies Vaccine, Modified Live Virus and Chlamydia, Canarypox 
Vector (Code 1619.R1);
    Product: Feline Rhinotracheitis-Calici-Panleukopenia-Rabies 
Vaccine, Modified Live Virus, Canarypox Vector (Code 16T9.R0); and
    Product: Feline Leukemia-Rhinotracheitis-Calici-Panleukopenia-
Rabies Vaccine, Modified Live and Killed Virus, Canarypox Vector (Code 
16S9.R0).
    Except for the canarypox-vectored rabies fraction, all components 
of the four products discussed in this notice are represented in 
currently licensed products.

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

    Done in Washington, DC, this 3rd day of July 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-18107 Filed 7-9-97; 8:45 am]
BILLING CODE 3410-34-P