[Federal Register: September 20, 2000 (Volume 65, Number 183)]
[Notices]
[Page 56863-56864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se00-47]
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[[Page 56863]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 00-084-1]
Availability of a Draft Environmental Assessment for Field
Testing Salmonella Typhimurium Vaccine, Live Culture
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 live Salmonella typhimurium 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 October 20, 2000.
ADDRESSES: Please send your comments and three copies to: Docket No.
00-084-1, 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. 00-084-1.
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 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; (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 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 following
unlicensed veterinary biological product:
Requester: Fort Dodge Laboratories, Inc.
Product: Salmonella Typhimurium Vaccine, Live Culture.
Field test locations: Georgia, South Carolina, and Maryland.
The above-mentioned vaccine is a gene-deleted vaccine for use in
chickens as an aid in the reduction of colonization of the internal
organs by Salmonella typhimurium. Genetic alterations limit the ability
of the vaccine bacteria to replicate in vertebrate tissues.
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
[[Page 56864]]
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 14th day of September 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection, Service.
[FR Doc. 00-24137 Filed 9-19-00; 8:45 am]
BILLING CODE 3410-34-P
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