[Federal Register: June 6, 2003 (Volume 68, Number 109)]
[Notices]
[Page 33903-33904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jn03-33]
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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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[[Page 33903]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 03-043-1]
Availability of an Environmental Assessment for Field Testing
Bursal Disease-Marek's Disease Vaccine
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 Bursal Disease-Marek's Disease Vaccine for
use in chickens. 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 July
7, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 03-043-1, 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. 03-043-1. If you use 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.
03-043-1'' on the subject line.
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.
You may request a copy of the environmental assessment (as well as
the risk analysis with confidential business information removed) by
writing to Dr. Patricia L. Foley, USDA, APHIS, VS, CVB-LPD, 510 South
17th Street, Suite 104, Ames, IA 50010, or by calling (515) 232-5785.
Please refer to the docket number, date, and complete title of this
notice when requesting copies.
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, 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, contact Dr. Patricia L. Foley, USDA, APHIS, VS, CVB-LPD, 510
South 17th Street, Suite 104, Ames, IA 50010; (515) 232-5785.
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 Select, Inc.
Product: Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live
Marek's Disease Virus, Serotype 3 Vector, Code 1A88.R0.
Field Test Locations: Georgia, North Carolina, and Texas.
The above-mentioned product is a combination Bursal Disease-Marek's
Disease Vaccine prepared using serotype 3 Marek's disease virus which
has been genetically modified to express a bursal disease virus
antigen. The vaccine is for use in chickens as an aid in the prevention
of disease caused by bursal disease virus and serotype 3 Marek's
disease 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
[[Page 33904]]
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 3rd day of June, 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-14301 Filed 6-5-03; 8:45 am]
BILLING CODE 3410-34-P