[Federal Register Volume 62, Number 75 (Friday, April 18, 1997)]
[Notices]
[Page 19097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10102]
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Notices
Federal Register
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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
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. 62, No. 75 / Friday, April 18, 1997 /
Notices
[[Page 19097]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 97-028-1]
Availability of an Environmental Assessment and Finding of No
Significant Impact
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 and a
finding of no significant impact for the shipment of an unlicensed
veterinary biological product for field testing. A risk analysis, which
forms the basis for the environmental assessment, has led us to
conclude that shipment of the unlicensed veterinary biological product
for field testing will not have a significant impact on the quality of
the human environment. Based on our finding of no significant impact,
we have determined that an environmental impact statement need not be
prepared. Therefore, with this notice, we state our intention to
authorize shipment of this product for field testing after 14 days from
the date of this notice, unless new substantial issues bearing on the
effects of the action contemplated here are brought to our attention.
Furthermore, with this notice, we also state our intention to issue a
veterinary biological product license for this product, provided the
field trial data support the conclusions of the original environmental
assessment and finding of no significant impact and the product meets
all other requirements for licensure.
ADDRESSES: Copies of the environmental assessment and finding of no
significant impact may be obtained by writing to the person listed
under FOR FURTHER INFORMATION CONTACT. When requesting copies, please
refer to the docket number of this notice, the product name and code
number, and the producer (requester). Copies of the environmental
assessment and finding of no significant impact (as well as the risk
analysis with confidential business information removed) are also
available for public inspection at USDA, room 1141, South Building,
14th Street and Independence Avenue SW., Washington, DC, between 8 a.m.
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing
to inspect those documents are requested to call ahead on (202) 690-
2817 to facilitate entry into the reading room.
FOR FURTHER INFORMATION CONTACT: Dr. Jeanette Greenberg, Technical
Writer-Editor, Center for Veterinary Biologics-Licensing and Policy
Development, VS, APHIS, USDA, 4700 River Road Unit 148, Riverdale, MD
20737-1231; telephone (301) 734-5338; fax (301) 734-8910.
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. In order
to ship an unlicensed veterinary biological product for the purpose of
conducting a proposed field test, a person must receive authorization
from the Animal and Plant Health Inspection Service (APHIS).
In determining whether to authorize shipment for field testing of
the unlicensed veterinary biological product referenced in this notice,
APHIS conducted a risk analysis to assess the potential effect of this
product on the safety of animals, the public health, and the
environment. Based on the risk analysis, APHIS has prepared an
environmental assessment (EA). APHIS has concluded that shipment of the
unlicensed veterinary biological product for field testing will not
significantly affect the quality of the human environment. Based on
this finding of no significant impact (FONSI), we have determined that
there is no need to prepare an environmental impact statement. An EA
and FONSI have been prepared by APHIS for the shipment of the following
unlicensed veterinary biological product for field testing:
Requester: Rhone Merieux, Inc.
Product: Avian Influenza-Fowl Pox Vaccine, Live Fowl Pox Vector,
Code 1061.R0.
Field test locations: Delaware, Georgia, Texas.
The EA and FONSI have been prepared in accordance with: (1) The
National Environmental Policy Act of 1969, as amended (NEPA) (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 authorize the shipment of the above
product and the initiation of the field tests after 14 days from the
date of this notice.
Because the issues raised by authorization of a field trial and
issuance of a license are identical, APHIS has concluded that the EA
and FONSI that were generated for the field trial would also be
applicable to the proposed licensing action. Furthermore, provided that
the field trial data support the conclusions of the original EA and
FONSI, APHIS does not intend to issue a separate EA to support the
issuance of the product license, and would determine that an
environmental impact statement need not be prepared. Therefore, APHIS
intends to issue a veterinary biological product license for this
product following the completion of the field trial, provided no
adverse impacts on the human environment are identified as a result of
field testing this product and provided the product meets all other
requirements for licensure.
Authority: 21 U.S.C. 151-159.
Done in Washington, DC, this 15th day of April 1997.
Donald W. Luchsinger,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-10102 Filed 4-17-97; 8:45 am]
BILLING CODE 3410-34-P
