[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Notices]
[Page 27916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13571]


      
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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 63, No. 98 / Thursday, May 21, 1998 / 
Notices  

[[Page 27916]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-050-1]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Testing Edwardsiella Ictaluri Vaccine

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 the field testing of an unlicensed live 
bacterial vaccine for use in catfish. 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. With this notice, we state our 
intention 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 the action contemplated here are brought to 
our attention. We also state our intention 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 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; 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. 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: Alpharma NW Inc.
    Product: Edwardsiella Ictaluri Vaccine, Avirulent Live Culture, 
Code 1531.R0.
    Field test locations: Arkansas, Louisiana, and Mississippi.
    The above-mentioned product is an aroA gene-deleted bacterial 
vaccine for use as an aid in preventing enteric septicemia in channel 
catfish.
    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 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 15th day of May 1998.
Charles P. Schwalbe,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-13571 Filed 5-20-98; 8:45 am]
BILLING CODE 3410-34-P