[Federal Register Volume 65, Number 112 (Friday, June 9, 2000)]
[Notices]
[Page 36661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14615]


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 Notices
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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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  Federal Register / Vol. 65, No. 112 / Friday, June 9, 2000 / 
Notices  

[[Page 36661]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-046-1]


Availability of a Draft Environmental Assessment for Field 
Testing Rinderpest Vaccine, Vaccinia Vector

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 a draft environmental assessment 
concerning authorization to ship to Kenya for the purpose of field 
testing, and then to field test in Kenya, an unlicensed, genetically 
engineered, vaccinia-vectored rinderpest vaccine for use in cattle. 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. 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.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by July 10, 2000.

ADDRESSES: Please send your comments and three copies to: Docket No. 
00-046-1, 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. 00-046-1.
    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 USDA South Building, 14th Street 
and Independence Avenue SW., Washington, DC. Normal reading room hours 
are 8 a.m. to 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, 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 have a reasonable expectation of efficacy before a 
field trial may be authorized. The purpose of a field trial is to 
gather additional information concerning the safety and efficacy of a 
vaccine when used under field conditions that are similar to those in 
the area(s) where the vaccine will be distributed and used. Prior to 
conducting a field test on an experimental vaccine, 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 vaccine 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: Dr. Tilahun Yilma, Director, International Laboratory of 
Molecular Biology for Tropical Disease Agents, School of Veterinary 
Medicine, University of California, Davis.
    Product: A live, genetically engineered, vaccinia-vectored 
rinderpest vaccine.
    Field test location: Kikuyu, Kenya.
    The above-mentioned vaccine is for use as an aid in the prevention 
of rinderpest in cattle. The vaccine was constructed with the Wyeth 
vaccine strain of the vaccinia virus and further attenuated by 
insertional inactivation of the thymidine kinase and hemagglutinin 
genes of the vaccinia virus.
    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 and authorize shipment of the above product for the 
initiation of field tests following the close of the comment period for 
this notice.

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

    Done in Washington, DC, this 5th day of June 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-14615 Filed 6-8-00; 8:45 am]
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