[Federal Register Volume 62, Number 212 (Monday, November 3, 1997)]
[Notices]
[Page 59338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29018]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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 delegations of authority, filing of petitions and applications and agency 
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  Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / 
Notices  

[[Page 59338]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-071-1]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Testing Salmonella Typhimurium 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 a 
finding of no significant impact for the shipment for field testing of 
an unlicensed bacterial vaccine for use in chickens. 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 
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 trial 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 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, VS, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD 
20737-1231; telephone (301) 734-5338; fax (301) 734-8910; 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 proposed 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, 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: Maine Biological Laboratories, Inc.
    Product: Salmonella Typhimurium Vaccine, Avirulent Live Culture, 
Code 19C1.01.
    Field test locations: Alabama, Delaware, Georgia, Maryland, North 
Carolina, and Virginia.
    The above-mentioned product is a gene-deleted vaccine for use as an 
aid in preventing paratyphoid in young chickens.
    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 14 days from the date of 
this notice.
    Because the issues raised by authorization of a field trial and 
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. Furthermore, 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 
vaccine following the completion of the field trial, provided no 
adverse impacts on the human environment are identified as a result of 
field testing and provided the product meets all other requirements for 
licensure.

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

    Done in Washington, DC, this 28th day of October 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-29018 Filed 10-31-97; 8:45 am]
BILLING CODE 3410-34-P