Federal Register: December 28, 2001 (Volume 66, Number 249)
DOCID: FR Doc 01-31946
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket ID: [Docket No. 01-119-1]
NOTICE: NOTICES
ACTION: Environmental statements; availability, etc.:
DOCUMENT ACTION: Notice of availability and request for comments.
SUBJECT CATEGORY:
Availability of an Environmental Assessment for Field Testing Avian Encephalomyelitis-Fowl Pox-Mycoplasma Gallisepticum Vaccine, Live Virus, Fowl Pox Vector
DATES: We invite you to comment on this docket. We will consider all comments we receive that are postmarked, delivered, or emailed by January 28, 2002.
DOCUMENT 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 encephalomyelitisfowl poxmycoplasma 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.
SUMMARY:
Avian encephalomyelitis-fowl pox-mycoplasma gallisepticum vaccine; field testing,
SUPPLEMENTAL 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
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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 EncephalomyelitisFowl PoxMycoplasma Gallisepticum Vaccine, Live Virus, Fowl Pox Vector.
Field test locations: Iowa, Minnesota, Nebraska, North Carolina, Pennsylvania, Texas, and Virginia.
The abovementioned 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 15001508), (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. 151159.
Done in Washington, DC, this 20th day of December 2001. W. Ron Dehaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 0131946 Filed 122701; 8:45 am]
BILLING CODE 341034P
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 207371231; telephone (301) 7348245, fax (301) 7344314.