[Federal Register: December 21, 2004 (Volume 69, Number 244)]
[Notices]
[Page 76448-76449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de04-28]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-084-1]
Availability of an Environmental Assessment for Field Testing
Equine Influenza Vaccine, Live Canarypox 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 an environmental assessment concerning
authorization to ship for the purpose of field testing, and then to
field test, an unlicensed Equine Influenza Vaccine, Live Canarypox
Vector for use in horses. 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 U.S. 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 licensing.
DATES: We will consider all comments that we receive on or before
January 20, 2005.
ADDRESSES: You may submit comments by any of the following methods:
EDOCKET: Go to http://www.epa.gov/feddocket to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once you have entered
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this
document.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to: Docket No. 04-084-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-084-1.
E-Mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 04-084-1'' on the subject
line.
Federal eRulemaking Portal: Go to http://www.regulations.gov
and follow the instructions for locating this
docket and submitting comments.
Reading Room: You may read the environmental assessment, the risk
analysis (with confidential business information removed), and any
comments that we receive 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.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, 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,
Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737-1231; phone (301) 734-8245, fax (301) 734-4314.
For information regarding the environmental assessment or the risk
analysis, or to request a copy of the environmental assessment (as well
as the risk analysis with confidential business information removed),
contact Dr. Louise M. Henderson, Center for Veterinary Biologics,
Policy, Evaluation, and Licensing VS, APHIS, 510 South 17th Street,
Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232-7120.
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 an environmental
assessment (EA) concerning the field testing of the following
unlicensed veterinary biological product:
Requester: Merial Limited.
Product: Equine Influenza Vaccine, Live Canarypox Vector.
[[Page 76449]]
Field Test Locations: Montana, Oklahoma, Iowa, Missouri, Tennessee,
and Florida.
The above-mentioned product is a live canarypox vector that has
been genetically modified to express genes from two equine influenza
virus strains. The vaccine is for use in horses as an aid in the
prevention of disease caused by equine influenza virus.
The 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 provision 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 issues with adverse environmental impacts are
raised in response to this notice, APHIS intends to issue a finding of
no significant impact (FONSI) based on the EA 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 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
licensing.
Authority: 21 U.S.C. 151-159.
Done in Washington, DC, this 14th day of December 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-27881 Filed 12-20-04; 8:45 am]
BILLING CODE 3410-34-P