[Federal Register Volume 60, Number 80 (Wednesday, April 26, 1995)]
[Notices]
[Pages 20476-20477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10241]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-031-1]
Availability of 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 issuance of a conditional
veterinary biological product license. A risk analysis, which forms the
basis for the environmental assessment, has led us to conclude that
issuance of this conditional license 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.
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. Please refer to the docket
number of this notice when requesting copies. 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, Veterinary
Biologics, BBEP, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
[[Page 20477]] 1237; telephone (301) 734-8400; fax (301) 734-8910.
SUPPLEMENTARY INFORMATION: A veterinary biological product regulated
under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.) must be shown
to be pure, safe, potent, and efficacious before a veterinary
biological product license may be issued. The regulations in 9 CFR part
102 regarding the licensing of biological products provide that a
conditional veterinary biological product license may be issued to meet
an emergency situation, limited market, local situation, or other
special circumstance. The special circumstance addressed here is the
current raccoon rabies epizootic in the United States. The product
being issued a conditional license is intended for vaccinating raccoons
against rabies. No other licensed product is currently available for
this purpose. The vaccination of raccoons is proposed to limit the
further spread of the raccoon rabies epizootic, and to prevent the
spread of rabies to domestic animals and to humans. Conditionally
licensed products are required to be pure and safe, and have a
reasonable expectation of efficacy.
In determining whether to issue a conditional license for the
veterinary biological product referenced in this notice, the Animal and
Plant Health Inspection Service (APHIS) conducted a risk analysis to
assess the product's potential effects on the safety of animals, public
health, and the environment. Based on that risk analysis, APHIS has
prepared an environmental assessment. APHIS has concluded that issuance
of a conditional veterinary biological product license for the
veterinary biological product referenced in this notice will not
significantly affect the quality of the human environment. Based on the
finding of no significant impact, we have determined that there is no
need to prepare an environmental impact statement.
An environmental assessment and a finding of no significant impact
have been prepared for the issuance of a conditional veterinary
biological product license for the following veterinary biological
product: Rabies Vaccine, Live Vaccinia Vector; Code 1901.R0; to be
issued to Rhone Merieux, Inc., Establishment License No. 298. This
recombinant rabies vaccine is intended for vaccinating raccoons against
rabies, and is not intended for use in pets. The conditional license
restricts the use of this product to State or Federal Government
agencies administering wildlife rabies control programs. The
availability of the recombinant rabies vaccine for use in rabies
control programs may be useful in limiting the spread of the current
rabies epizootic in the United States.
A conditional license has been issued on the basis that the product
has been demonstrated to be pure and safe, and to have a reasonable
expectation of efficacy. The product has not met the efficacy
requirements of title 9, Code of Federal Regulations, Sec. 113.312 for
rabies vaccines; however, a reasonable expectation of efficacy has been
demonstrated in the studies that have been conducted to date. The
efficacy of this recombinant rabies vaccine will be further evaluated
during the conditional license period. The State and Federal Government
agencies using the rabies vaccine will be provided with detailed
instructions for safely using the recombinant vaccine. These
instructions include continued use of the following mitigative
procedures that have been implemented for the field tests previously
conducted with this product:
1. Public education efforts, including education efforts directed
at school-aged children, should be conducted prior to distributing the
baits containing the recombinant rabies vaccine. Warning labels should
be attached to the baits to minimize the possibility of accidental
exposure of members of the local populations in the areas where the
vaccine-laden baits are distributed. The warning labels should clearly
identify the recombinant vaccine and list the phone number for the
local public health authorities. The public education efforts should be
conducted prior to distributing the baits and should include newspaper
articles, local television reports, and the distribution of brochures
and posters. Public information meetings may also be used. In addition,
when the baits are distributed, signs should be posted at the periphery
and at strategic points within the distribution area notifying visitors
of the rabies control efforts and warning them not to disturb the
vaccine-laden baits.
2. The local public health authorities in the areas where the
recombinant rabies vaccine is used should be notified prior to the
distribution of the baits. The public health authorities should be
instructed to inform the authorizing State or Federal Government agency
of any reported human contacts with the vaccine-laden baits.
Individuals who may have been exposed to the vaccine should be examined
for any adverse reactions or clinical signs of orthopoxvirus infection,
and have blood samples drawn and analyzed for the presence of
antibodies of rabies and/or vaccinia.
3. The personnel conducting the rabies control programs should be
trained in the appropriate precautions and techniques for assembling,
handling, and distributing the vaccine-laden baits. These personnel
should be encouraged to be vaccinated against vaccinia, as recommended
by the U.S. Public Health Service [Morbidity and Mortality Weekly
Report; Recommendations and Reports; Vaccinia (Smallpox) Vaccine,
Recommendations of the Immunization Practices Advisory Committee
(ACIP), Vol. 40, pp. 1-10 (1991)], and also be vaccinated against
rabies. All personnel should be non-pregnant adults at least 18 years
of age, who are free of any known immunosuppressive conditions. Regular
blood samples should be collected from the personnel and monitored for
the presence of rabies and vaccinia antibodies.
4. The filling of the liquid vaccine into ampules for assembly into
the baits should be conducted according to Biosafety Level-2 (BL-2)
criteria [CDC-NIH Manual: Biosafety in Microbiological and Biomedical
Laboratories, Third Edition (1993) pp. 18-24].
5. Any adverse reactions observed in the areas where the
recombinant rabies vaccine is used should be reported to the licensed
manufacturer, who will forward this information to Veterinary
Biologics, APHIDS.
The environmental assessment and finding of no significant impact
have been prepared in accordance with: (1) The National Environmental
Policy Act of 1969 (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 (60 FR 6000-6005, February 1, 1995).
Done in Washington, DC, this 20th day of April 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-10241 Filed 4-25-95; 8:45 am]
BILLING CODE 3410-34-M
