[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Pages 34142-34143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16136]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 01-051-1]
Availability of a Draft Environmental Assessment for Field
Testing Avian Encephalomyelitis-Fowl Pox-Laryngotracheitis Vaccine,
Live Virus, Fowl Pox 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 for the purpose of field testing, and
then to field test, an unlicensed avian encephalomyelitis-fowl pox-
laryngotracheitis 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 July 27, 2001.
ADDRESSES: Please send four copies of your comment (an original and
three copies) to: Docket No. 01-051-1, 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. 01-051-1.
Copies of the draft environmental assessment may be obtained by
contacting the person listed under FOR
[[Page 34143]]
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. 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, Operational Support Section, Center for Veterinary Biologics,
Licensing and Policy Development, VS, APHIS, USDA, 4700 River Road,
Unit 148, Riverdale, MD 20737-1231; telephone (301) 734-8245; fax (301)
734-4314.
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
combined unlicensed and licensed veterinary biological product:
Requester: Biomune Company.
Product: Avian Encephalomyelitis-Fowl Pox-Laryngotracheitis
Vaccine, Live Virus, Fowl Pox Vector.
Field test locations: Georgia, Kentucky, Nebraska, Texas, and
Virginia.
The above-mentioned product is a modified live avian
encephalomyelitis vaccine in combination with a live, attenuated fowl
pox virus that has been genetically modified to express fowl
laryngotracheitis antigens. The vaccine is for use in chickens as an
aid in the prevention of avian encephalomyelitis, fowl pox, and
laryngotracheitis.
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 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 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 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 21st day of June 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-16136 Filed 6-26-01; 8:45 am]
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