[Federal Register Volume 66, Number 249 (Friday, December 28, 2001)]
[Notices]
[Pages 67169-67170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31946]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-119-1]


Availability of an Environmental Assessment for Field Testing 
Avian Encephalomyelitis-Fowl Pox-Mycoplasma Gallisepticum Vaccine, Live 
Virus, Fowl Pox Vector

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

-----------------------------------------------------------------------

SUMMARY: We are informing 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 avian encephalomyelitis-fowl pox-mycoplasma 
gallisepticum 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 we receive that are postmarked, delivered, or e-mailed by 
January 28, 2002.

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. 01-119-1, 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. 01-119-1. If you use e-mail, 
address your comment to [email protected]. 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. 
01-119-1'' on the subject line.
    Copies of the environmental assessment may be obtained from 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 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, 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

[[Page 67170]]

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 veterinary 
biological product:
    Requester: Biomune Company.
    Product: Avian Encephalomyelitis-Fowl Pox-Mycoplasma Gallisepticum 
Vaccine, Live Virus, Fowl Pox Vector.
    Field test locations: Iowa, Minnesota, Nebraska, North Carolina, 
Pennsylvania, 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 Mycoplasma 
gallisepticum antigens. The vaccine is for use in chickens as an aid in 
the prevention of avian encephalomyelitis, fowl pox, and Mycoplasma 
gallisepticum.
    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 environmental issues 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 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 the product meets all other requirements for licensure.

    Authority: 21 U.S.C. 151-159.

    Done in Washington, DC, this 20th day of December 2001.
W. Ron Dehaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-31946 Filed 12-27-01; 8:45 am]
BILLING CODE 3410-34-P