[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
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.
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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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