[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Notices]
[Pages 13697-13700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5590]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-009-1]


Control of Rabies in Wildlife; Request for Public Involvement

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Animal and Plant Health Inspection Service's Wildlife 
Services program is soliciting public involvement in the planning of a 
proposed cooperative program to stop the spread of rabies in the States 
of New York, Ohio, Texas, Vermont, and West Virginia. A small portion 
of northeastern New Hampshire and the western counties in Pennsylvania 
that border Ohio could also be included in these control efforts. In 
addition, Wildlife Services may cooperate in smaller scale oral rabies 
vaccine projects in the States of Florida, Massachusetts, Maryland, New 
Jersey, Virginia, and Alabama. The information received in response to 
this notice will be considered during the planning of the proposed 
program and development of an environmental assessment that will be 
prepared in accordance with the National Environmental Policy Act.

DATES: We invite you to comment on this notice. We will consider all 
comments that we receive by April 6, 2001.

ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 01-009-1, 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. 01-009-1.
    You may read any comments that we receive on this docket 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.
    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: Mr. Dennis Slate, Rabies Program 
Coordinator, Wildlife Services, APHIS, 59 Chennell Drive, Suite 7, 
Concord, NH 03301-8548; phone (603) 223-6832.

SUPPLEMENTARY INFORMATION: Rabies is an acute, fatal viral disease of 
mammals most often transmitted through the bite of a rabid animal. The 
disease can be effectively prevented in humans and domestic animals, 
but abundant and widely distributed reservoirs among wild mammals 
complicate rabies control. The vast majority of rabies cases reported 
to the Centers for Disease Control and Prevention (CDC) each year occur 
in raccoons, skunks, bats, foxes, and other wild animals. Domestic 
animals account for less than 10 percent of the reported rabies cases, 
with cats, dogs, and cattle among those most often reported.
    Public health importance of rabies. Over the last 100 years, the 
rabies situation in the United States has changed dramatically. About 
90 percent or greater of all animal cases reported annually to CDC now 
occur in wildlife, whereas before 1960 the majority of cases were 
reported in domestic animals. The principal rabies hosts today are wild 
carnivores and bats. The number of rabies-related human deaths in the 
United States has declined from more than 100 annually at the beginning 
of the 20th century to an average of one or two people per year in the 
1990's. Modern prophylaxis, which consists of a series of vaccine 
injections given to people who have been exposed, has proven nearly 100 
percent successful in preventing mortality when administered promptly 
after exposure. In the United States, human fatalities associated with 
rabies occur in people who fail to seek timely medical assistance, 
usually because they were unaware of their exposure.
    Although human rabies deaths are rare, the estimated public health 
costs associated with disease detection, prevention, and control have 
risen, exceeding $300 million annually. These costs include the 
vaccination of companion animals, animal control programs, maintenance 
of rabies laboratories, and medical costs, such as those incurred for 
exposure case investigations and rabies post-exposure prophylaxis 
(PEP).
    Accurate estimates of these expenditures are not available. 
Although the number of PEP's given in the United States each year is 
unknown, it is estimated to be about 40,000. When rabies becomes 
epizootic (epidemics in animals) or enzootic (i.e., present in an area 
over time but at low case

[[Page 13698]]

frequency) in a region, the number of PEP's in that area increases. 
Although the cost varies, a course of rabies immune globulin and five 
doses of vaccine given over a 4-week period typically exceeds $1,000 
and may be as high as $2,000.
    Rabies in raccoons was virtually unknown prior to the 1950's. It 
was first described in Florida and spread slowly during the next three 
decades into Georgia, Alabama, and South Carolina. It was 
unintentionally introduced into the mid-Atlantic States by 
translocation of infected animals. The first cases appeared in West 
Virginia and Virginia in 1977 and 1978. Since then, raccoon rabies in 
the area has expanded to form the most intensive rabies outbreak in the 
United States.
    Two rabies epizootics emerged in Texas in 1988; one involved 
spillover of canine dog rabies into coyotes in south Texas, and the 
other involved a rabies variant unique to gray foxes in west-central 
Texas. The south Texas epizootic alone resulted in 2 human deaths and 
caused over 3,000 people to receive post-exposure rabies treatment. In 
1994, the public health threat created by these two expanding 
epizootics prompted the Governor of Texas to declare rabies a public 
health emergency in Texas.
    Primary need for action. If the rabies strains transmitted by 
raccoons, gray foxes, and coyotes are not prevented from spreading to 
broader areas of the United States, the health threats and costs 
associated with rabies are expected to increase substantially. In the 
area that stretches west from the leading edge of the current 
distribution of raccoon rabies (which stretches from Alabama 
northeastward along the Appalachian Mountains to Maine) to the Rocky 
Mountains, and north from the distribution of gray fox and coyote 
rabies in Texas, there are more than 111 million livestock animals--
including cattle, horses, mules, swine, goats, and sheep--valued at $42 
billion. If raccoon, gray fox, or coyote rabies were to spread into the 
above described area, the livestock there would be at risk from these 
specific rabies variants. More importantly, human health care concerns 
would be expected to increase substantially as well if raccoon, coyote, 
and gray fox strains of rabies infect a much broader geographic area.
    Development of oral rabies vaccine (ORV) programs. Although the 
concept of ORV to control rabies in free-ranging wildlife populations 
originated in the United States, it has a longer history of 
implementation in Europe and Canada. The emergence of raccoon rabies in 
the United States during the 1970's heightened interest in the 
application of ORV to raccoons. Due to biological and ecological 
differences between the types of animals that transmit rabies, 
development of specific vaccine and bait combinations was necessary. 
One of the main difficulties was the development of a safe and 
effective vaccine for raccoons. In contrast to red foxes, which were 
the primary subjects of ORV programs in Europe and Canada, raccoons 
were not readily immunized by the oral route with the modified live 
rabies virus vaccines that worked well in foxes. In addition, modified 
``live virus'' vaccines pose a small risk of vaccine-induced rabies and 
resulted in some cases of vaccine-induced rabies associated with oral 
baiting programs in Europe and Canada. However, a genetically 
engineered vaccine, vaccinia-rabies glycoprotein (V-RG), has proven to 
be effective orally in raccoons, coyotes, and foxes. V-RG was 
extensively evaluated in the laboratory for safety in over 50 
vertebrate species with no adverse effects, regardless of route or 
dose. Following successful field safety testing in the early 1990's, V-
RG was licensed in 1995 in the United States for vaccination of free-
ranging raccoons. It remains the only effective vaccine licensed for 
use in the United States for raccoons. It has also been approved for 
experimental use to vaccinate wild gray foxes and coyotes in Texas.
    V-RG is commercially available from Merial, 115 Transtech Drive, 
Athens, GA 30601, under the registered name Raboral V-RG. It 
is currently the only licensed oral vaccine available for rabies 
control for carnivores in the United States. V-RG is a recombinant 
vaccine that uses vaccinia, a living pox virus, as the vector (i.e., 
carrier) for the rabies gene that encodes for the production of rabies 
antigen in the form of rabies glycoprotein. Rabies glycoprotein is the 
protective sheath around the bullet-shaped rabies virus. The 
glycoprotein by itself is noninfective and cannot cause rabies, but, 
because it serves as the rabies antigen, it elicits an immune antibody 
response to rabies when the vaccine is swallowed by raccoons, foxes, or 
coyotes. When raccoons, foxes, or coyotes swallow the V-RG vaccine, it 
bathes the lymphatic tissue in the throat area and initiates the 
immunization process.
    There is no possibility of vaccine-induced rabies with Raboral V-
RG because the vaccine only contains the noninfective surface 
protein of the rabies virus; none of the viral nuclear material that 
would be required for the rabies virus to replicate is present in the 
vaccine. Over 22 million doses of Raboral V-RG have been 
distributed in the United States since 1994, with only one reported 
case of adverse effects on humans (i.e., a single case of a vaccinia 
virus infection, which caused localized skin rashes). This vaccine has 
been tested in 59 wild mammalian and avian species without adverse 
effects. In addition, a domestic animal's annual rabies vaccination can 
be safely administered even if it recently ingested a dose of oral 
rabies vaccine.
    The V-RG vaccine is most often encased in baits and distributed by 
aircraft. The baits are small blocks of fishmeal (for coyotes and 
raccoons) or dog food (for gray foxes) that are held together with a 
polymer binding agent. The sachet, a thin plastic packet containing the 
liquid vaccine, is in the middle of the bait. Efforts to provide for 
more efficient delivery of vaccine/bait packages to wildlife 
populations at lower cost have resulted in the development of 
``baitless'' sachets, in which the vaccine is enclosed within a plastic 
sachet that has been coated with special waxes and attractants, rather 
than the thick outer package of edible meal. These baitless sachets, 
which can be prepared without extensive manual labor and for less cost 
in materials, are smaller and lighter than other oral rabies vaccine 
baits, allowing for the possibility that more baits can be transported 
via aircraft, and smaller, less expensive aircraft can be used. Another 
attribute of the baitless sachet is that it is not possible for the 
animal to eat the edible material and leave the un-ruptured vaccine 
container behind. Field trials to date have shown that it performs very 
well in delivering vaccine to raccoons and coyotes. While the 
traditional fishmeal/dog food baits are likely to be used in most 
cases, it is possible that APHIS-WS and the States may employ baitless 
sachets, depending on their availability, in the course of the proposed 
cooperative program.
    Oral wildlife vaccination for raccoon rabies control has been under 
field evaluation in the United States since 1990. A limited field 
release of the recombinant vaccine occurred on Parramore Island, VA, 
prior to wider use in the United States for control of raccoon rabies. 
A major objective of that field trial was to evaluate the free-ranging 
raccoon population for adverse effects after the distribution of V-RG 
vaccine-laden baits. With the development and field testing of the V-RG 
vaccine, a potential method of rabies control now exists for some 
rabies variants to complement methods of control that include public 
education, domestic animal vaccination, and human post-exposure 
prophylaxis.

[[Page 13699]]

    Since the first field release of the V-RG vaccine in 1990, the 
annual number of vaccine-laden baits distributed to better understand 
the role of ORV for raccoon rabies control in the United States has 
risen exponentially.\1\ Eleven field projects have been conducted or 
are in progress in Pennsylvania (1991-1992), New Jersey (1992-1994, 
with further projects reinitiated in the last couple of years), 
Massachusetts (1994-present), Florida (1995-present), New York (1994-
present), Vermont (1997-present), Ohio (1997-present), Maryland (1998), 
and Virginia (2000). Since 1995, more than 13.25 million individual 
doses of ORV have been distributed over 196,000 square miles of 
southern and west-central Texas for control of rabies strains in 
coyotes and gray foxes.
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    \1\ A total of over 800,000 V-RG vaccine-laden baits were 
distributed in 1997.
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    Several pilot projects were conducted to evaluate the effect of ORV 
baiting upon raccoon rabies. Through intensive baiting efforts at the 
peninsular neck, raccoon rabies was prevented from invading the Cape 
Cod peninsula. A recently completed project in Albany and Rensselaer 
Counties in New York demonstrated that raccoon rabies may be virtually 
eliminated from an area where the disease had been present for a number 
of years by use of ORV. In Ohio, along the Pennsylvania border from 
Lake Erie to West Virginia, twice-yearly baiting has been successful to 
date in preventing the westward spread of raccoon rabies.
    Previous rabies control activities by Wildlife Services. The Animal 
and Plant Health Inspection Service's (APHIS) Wildlife Services (WS) 
program is authorized to conduct programs to address wildlife-caused 
disease problems by the Animal Damage Control Act of 1931 and the Rural 
Development, Agriculture and Related Agencies Act of 1988. WS's 
previous involvement in rabies prevention and control has been to 
provide technical and operational assistance to State health 
departments in experimental and operational distribution of ORV baits; 
in some of those States, WS has also assisted in the collection of 
animal specimens for monitoring purposes.
    Proposed programs. APHIS-WS is proposing to cooperate in State 
programs to stop the spread of rabies in the States of New York, Ohio, 
Texas, Vermont, and West Virginia. A small portion of northeastern New 
Hampshire and the western counties in Pennsylvania that border Ohio 
could also be included in these control efforts. In addition, APHIS-WS 
may cooperate in smaller scale ORV projects in the States of Florida, 
Massachusetts, Maryland, New Jersey, Virginia, and Alabama. 
Consequently, we are soliciting public involvement in the planning 
process. The proposal is to provide Federal funds authorized by 
Congress to: (1) Purchase ORV baits that would be distributed by air 
and ground placement; (2) provide other forms of assistance in 
monitoring rabies and determining the effectiveness of the ORV programs 
through collection and testing of samples from wild animal specimens; 
and (3) if the targeted rabies strains advance beyond the barriers 
created by the ORV zones, participate in implementing contingency plans 
to restore the integrity of the ORV barrier and prevent further spread 
of rabies. Such contingency plans may involve increased distribution of 
ORV baits in and around the ORV zones or, if necessary, the localized 
reduction of target species populations through lethal means.
    The intent of the bait distribution is to orally vaccinate wild 
raccoons in portions of the above-listed States with the exception of 
Texas. Similar programs would be directed at gray foxes in west-central 
Texas and coyotes in southern Texas. The primary goals of the program 
are to: (1) Stop the forward advance of these strains of rabies from 
areas where they now occur by immunizing portions of target species 
populations along the leading edges of the rabies fronts; and (2) 
reduce the incidence of rabies cases involving wild and domestic 
animals and rabies exposure to humans in the areas where the ORV 
programs are conducted.
    The areas over which the ORV baits would be distributed and from 
which animal specimens would be collected could be anywhere in the 
above-listed States. The ORV zones would be delineated based on the 
most current distribution of rabies cases and the expected direction of 
disease spread. Vaccination zones would be determined in cooperation 
with State health departments and other State agencies with 
jurisdiction over wildlife and domestic animals. Pending the 
verification of legal authorities to do so, ORV baits would be 
distributed over a variety of classes of land ownership, including 
private, public, tribal, and other State and Federal lands. Each 
individual bait would have a warning label advising persons not to 
handle or disturb the bait along with a toll-free telephone number to 
call for further information.
    Wild animal collections for purposes of monitoring would be 
conducted using a variety of live capture or lethal methods. 
Information from raccoons would be predominantly collected from cage-
trapped individuals that, if apparently healthy, would be released at 
or near their site of capture. The requisite sample from coyotes would 
be obtained primarily by aerial or ground-based shooting from sample 
areas within the ORV zone. Gray fox samples would be obtained by ground 
shooting and various capture methods including leghold traps, cage 
traps, foot snares, and wire cable neck snares. Only legally approved 
methods would be used in all animal sample collection areas to provide 
critical data for the evaluation of project effectiveness. Project 
effectiveness would be based in large part on the percentage of ORV 
baits consumed in populations of target species and by the presence of 
sufficient levels of serum neutralizing antibodies to produce immunity 
to rabies as determined from serological analysis of blood samples 
obtained from target species within ORV zones.
    In the event that the targeted rabies strains advance beyond the 
barriers created by the ORV zones, contingency plans may be implemented 
by the involved States that could involve local population suppression 
of the target wildlife species using lethal means. Another type of 
contingency plan to address such outbreaks might be to distribute 
higher densities of ORV baits in and around such areas to attempt to 
arrest the outbreak without resorting to lethal population suppression. 
If any localized lethal population control efforts were undertaken, 
those efforts would likely be integrated with hand or aerial placement 
of ORV baits in and around the population suppression area to restore 
the integrity of the ORV barrier and prevent further spread of rabies. 
APHIS-WS may, as part of the proposed action, assist in such efforts by 
providing funds, personnel, or equipment to capture and kill target 
species. Should this occur, methods used would involve any of those 
described above for the collection of wild animal specimens. In Texas, 
an additional method that could be used to remove gray foxes and 
coyotes would be sodium cyanide in the M-44 device, which is approved 
by the U.S. Environmental Protection Agency for this purpose. The need 
for APHIS-WS involvement in contingency plans that employ localized 
lethal population suppression is considered to be unlikely.
    We are encouraging members of the public and other interested 
agencies and organizations to assist in the planning of this program by 
answering the following questions:

[[Page 13700]]

     What issues or concerns about the distribution of ORV 
baits by air and ground should we analyze?
     What other issues or concerns about the proposed action do 
you think we should address?
     What alternatives to the proposed action should we 
analyze?
     Do you have any information (i.e., scientific data or 
studies) that we should consider in the analysis?
    Information received will be considered in an environmental 
assessment (EA) prepared in accordance with the National Environmental 
Policy Act.
    Issues and alternatives identified thus far. Several issues have 
already been identified as areas of concern for consideration in the 
EA:
     Potential for adverse effects on people that become 
exposed to the vaccine or the baits.
     Potential for adverse effects on nontarget wildlife 
species that might consume the baits.
     Potential for adverse effects on pet dogs or other 
domestic animals that might consume the baits.
     Potential for aerially dropped baits to strike and injure 
people or domestic animals.
     Cost of the program in comparison to perceived benefits.
     Humaneness of methods used to collect wild animal 
specimens critical for timely program evaluation.
    Other issues may also be included in the analysis and will be 
identified based on comments obtained through gathering information 
from the public and other agencies. Several alternatives that have been 
identified for consideration are:
     No involvement by APHIS-WS in rabies prevention or 
control.
     Implement the proposed action.
     Live capture of species being targeted (e.g., raccoon, 
gray fox, coyotes) followed by administration of rabies vaccines by 
injection and release back into the wild.
     Provide resources for ORV bait distribution without 
collection of wild animal specimens by APHIS-WS for monitoring 
purposes.
    Other alternatives may also be included in the analysis based on 
comments obtained through gathering information from the public and 
other agencies.
    Availability of additional information. Further information on 
rabies and ORV may be obtained from CDC Internet website (http://www.cdc.gov) and from the vaccine manufacturer, Merial (http://www.merial.com, e-mail: [email protected]). Further information on the 
status of ORV program planning efforts within the involved individual 
States may be available by contacting individual State health 
departments. Links to individual State health department Internet 
websites are available on the CDC Internet website. Information 
regarding APHIS-WS rabies control activities may be obtained by calling 
or writing the person listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 2nd day of March 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-5590 Filed 3-6-01; 8:45 am]
BILLING CODE 3410-34-U