[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Notices]
[Pages 47710-47711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19609]


 ========================================================================
 Notices
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
 
 ========================================================================
 

  Federal Register / Vol. 65, No. 150 / Thursday, August 3, 2000 / 
Notices  

[[Page 47710]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-069-1]


Availability of a Draft Environmental Assessment for Field 
Testing Salmonella Typhimurium Vaccine, Live Culture

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 a draft environmental assessment 
concerning authorization to ship for the purpose of field testing, and 
then to field test, an unlicensed live Salmonella typhimurium vaccine 
for use in poultry. The environmental assessment, which is based on a 
risk analysis prepared to assess the risks associated with the field 
testing of this vaccine, examines the potential effects that field 
testing this veterinary vaccine could have on the quality of the human 
environment. Based on the risk analysis, we have reached a preliminary 
determination that field testing this veterinary vaccine will not have 
a significant impact on the quality of the human environment, and that 
an environmental impact statement need not be prepared. We intend to 
authorize shipment of this vaccine for field testing following the 
close of the comment period for 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 the issuance of a 
finding of no significant impact and the product meets all other 
requirements for licensure.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by September 5, 2000.

ADDRESSES: Please send your comments and three copies to: Docket No. 
00-069-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 
4700 River Road, Unit 118, Riverdale, MD 20737-1238.
    Please state that your comment refers to Docket No. 00-069-1.
    Copies of the draft environmental assessment 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. A copy of the draft environmental 
assessment (as well as the risk analysis with confidential business 
information removed) and any comments that we receive on this docket 
are available for public inspection in our reading room. The reading 
room is located in room 1141 of the South Building, 14th Street and 
Independence Avenue SW., Washington, DC. Normal reading room hours are 
8 a.m. and 4:30 p.m., Monday through Friday, except holidays. To be 
sure someone is there to help you, please call (202) 690-2817 before 
coming.
    APHIS documents published in the Federal Register , and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff 
Officer, Operational Support Section, Center for Veterinary Biologics, 
Licensing and Policy Development, VS, APHIS, USDA, 4700 River Road Unit 
148, Riverdale, MD 20737-1231; (301) 734-8245.

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.
    To determine 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 a draft environmental 
assessment (EA) concerning the field testing of the following 
unlicensed veterinary biological product:
    Requester: Biomune Company.
    Product: Salmonella Typhimurium Vaccine, Live Culture.
    Field test locations: Texas, Georgia, and Delaware.
    The above-mentioned vaccine is for use in chickens as an aid in the 
reduction of colonization of the internal organs by Salmonella 
typhimurium. Genetic alterations limit the ability of the vaccine 
bacteria to replicate in vertebrate tissues.
    The draft EA has 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 issue a final EA and finding of no 
significant impact (FONSI) and authorize shipment of the above product 
for the initiation of field tests following the close of the comment 
period for this notice.
    Because the issues raised by field testing and by issuance of a 
license are identical, APHIS has concluded that the EA that is 
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 the issuance of a FONSI, APHIS does 
not intend to issue a separate EA and FONSI 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

[[Page 47711]]

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 24th day of July 2000.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-19609 Filed 8-2-00; 8:45 am]
BILLING CODE 3410-34-P