##### ![](media/image1.png){width="0.6944444444444444in" height="0.9048611111111111in"}![](media/image2.png){width="0.7472222222222222in" height="0.7458333333333333in"}

**The U.S. Department of the Interior**

**Animal and Plant Health Inspection Service**

**U.S. Department of Agriculture**

**[Eastern Rivers and Mountains Network Parks:]{.underline}**

**Allegheny Portage Railroad National Historic Site, PA**

**Delaware Water Gap National Recreation Area, PA & NJ**

**Fort Necessity National Battlefield, PA**

**Friendship Hill National Historic Site, PA**

**Johnstown Flood National Memorial, PA**

**Bluestone National Scenic River, WV**

**Gauley River National Recreation Area, WV**

**New River Gorge National River, WV**

######### Oral Rabies Vaccination Program

######### Environmental Assessment /Assessment of Effect

## December, 2004 

## 

## Environmental Assessment

**Assessment of Effect**

# Oral Rabies Vaccination Program

**[Eastern Rivers and Mountains Network Parks:]{.underline}**

**Allegheny Portage Railroad National Historic Site, PA**

**Delaware Water Gap National Recreation Area, PA & NJ**

**Fort Necessity National Battlefield, PA**

**Friendship Hill National Historic Site, PA**

**Johnstown Flood National Memorial, PA**

**Bluestone National Scenic River, WV**

**Gauley River National Recreation Area, WV**

**New River Gorge National River, WV**

### Summary

This Environmental Assessment (EA) documents the analysis of the
potential environmental effects of a proposal to involve the U.S.
Department of Interior (USDI), National Park Service (NPS) in an oral
rabies vaccination (ORVAC) program at several park units (listed above)
within the NPS Northeast Region's Eastern Rivers and Mountains Network
Parks grouping in Pennsylvania, New Jersey, and West Virginia. The
program would involve the distribution of ORVAC baits to create zones of
vaccinated target species that would then serve as barriers to further
cease the advancement of raccoon rabies virus variants. The proposed
ORVAC program would reduce the possibility of humans and animals
becoming infected with the raccoon variant of the rabies virus and would
support the states of Pennsylvania, New Jersey, and West Virginia in the
effort of stopping the spread of a specific raccoon rabies variant or
"strain" of the rabies virus and reducing or eliminating this strain of
the virus from the eastern United States. Currently, cooperative rabies
vaccination programs are already being conducted on various land classes
in each of the aforementioned states in addition to numerous other
states in the eastern U.S. By participating, the NPS would aid in
enhancing the effectiveness of the national program. No cumulative
impacts are anticipated from the distribution of ORVAC into the
environment.

### Public Comment

If you wish to comment on the EA, you may mail comments to the name and
address below. This EA will be on public review for 30 days. Please note
that names and addresses of people who comment become part of the public
record. **If you wish us to withhold your name and/or address, you must
state this prominently at the beginning of your comment.** We will make
all submissions from organizations, businesses, and from individuals
identifying themselves as representatives or officials of organizations
or businesses available for public inspection in their entirety.

USDA-APHIS-WS

Attn: Wendy Servoss

Environmental Coordinator

6213 Angus Drive, Suite E

Raleigh, NC 27617

\(919\) 786-4480 x229

\(919\) 782-4159 fax

The U.S. Department of the Interior, National Park Service • U.S.
Department of Agriculture, Animal and Plant Health Inspection Service

**EXECUTIVE SUMMARY**

This Environmental Assessment (EA) documents the analysis of the
potential environmental effects of a proposal to involve the U.S.
Department of Interior (USDI), National Park Service (NPS) in an oral
rabies vaccination (ORVAC) program at several park units within the NPS
Northeast Region's Eastern Rivers and Mountains Network Parks grouping
in Pennsylvania, New Jersey, and West Virginia. The EA analyzes a number
of environmental issues or concerns with the oral rabies vaccine and
activities associated with the program.

The states of Pennsylvania, New Jersey, and West Virginia are involved
in an ORVAC program to stop the spread of specific raccoon (*Procyon
lotor*) rabies variants or "strains" of the rabies virus and reduce or
eliminate this strain of the virus from the eastern United States. If
not stopped, these strains could potentially spread to a much broader
area of the U.S. and cause substantial increases in public and domestic
animal health costs because of increased rabies exposures. The proposed
action would be conducted in cooperation with the various state agencies
(i.e., health departments, agriculture departments, and wildlife
agencies), U.S. Department of Agriculture (USDA), Animal and Plant
Health Inspection Service, Wildlife Services (APHIS-WS), and/or other
agencies with jurisdiction over vaccine use and application in wildlife
and domestic animal species. The program would involve the distribution
of ORVAC baits to create zones of vaccinated target species that would
then serve as barriers to further cease the advancement of raccoon
rabies virus variants. The action would involve the use of APHIS-WS
federal funds to purchase and distribute ORVAC baits.

[]{.mark}

The proposed ORVAC program would reduce the possibility of humans and
animals becoming infected with the raccoon variant of the rabies virus
and would support the states of Pennsylvania, New Jersey, and West
Virginia in the effort of stopping the spread of a specific raccoon
rabies variant or "strain" of the rabies virus and reducing or
eliminating this strain of the virus from the eastern U.S. Currently,
cooperative rabies vaccination programs are already being conducted on
various land classes in each of the aforementioned states in addition to
numerous other states in the eastern U.S. By participating, the NPS
would aid in enhancing the effectiveness of the national program. If
baiting programs were conducted around these large land masses,
reservoirs of the virus would likely still exist, creating holes in the
program and potentially making the program less effective at stopping
the forward advance or eliminating the raccoon strain of the rabies
virus. No cumulative impacts are anticipated from the distribution of
ORVAC into the environment. The ORVAC vaccine and bait that would be
used has been found safe to use on raccoon and other animal species, has
a negligible risk of causing adverse affects to humans, is readily
consumed by target animal species, and does not cause bioaccumulation in
the environment. A limited number of baits would be distributed one time
per year, thereby limiting the potential for persons to be exposed to an
ORVAC bait or to bait distributing equipment.

**Table of Contents**

**1.0 CHAPTER 1: PURPOSE OF AND NEED FOR ACTION**

1.1 BACKGROUND

> 1.1.1 Introduction
>
> 1.1.2 Public Health Importance of Rabies
>
> 1.1.3 Raccoon Rabies in the Eastern U.S.
>
> 1.1.4 Development of ORVAC and ORVAC Baits
>
> 1.1.5 Development of ORVAC Programs in the United States

1.2 DESCRIPTION AND PURPOSE OF THE PROPOSED PROGRAM

1.3 NEED FOR ACTION

> 1.3.1 Need for a Raccoon ORVAC Program

1.4 AUTHORITIES

1.5 OTHER RELEVANT FEDERAL LAWS AND REGULATIONS

1.6 RELATIONSHIP TO OTHER ENVIRONMENTAL DOCUMENTS

1.7 DECISION TO BE MADE

1.8 GOALS

1.9 SCOPE OF THIS ENVIRONMENTAL ASSESSMENT ANALYSIS

1.10 SCOPING PROCESS

**2.0 CHAPTER 2: ISSUES AND AFFECTED ENVIRONMENT**

2.1 ISSUES

2.2 ISSUES DISMISSED FROM FURTHER ANALYSIS

> 2.2.1 Potential for Adverse Impacts on Wildlife from Aircraft
> Overflights

2.2.2 Potential Human Health Impacts Resulting from the Human
Consumption of a Vaccinated Wild Animal

2.2.3 Potential for ORVAC Bait Distribution to Affect Organic Farming

2.2.4 Potential Impacts on Water Resources

2.2.5 The Affected Area includes NPS Lands that Have Not Been Identified
as Having a Rabid Raccoon Problem

2.2.6 Effects on Carnivore Populations in the Absence of Rabies

2.2.7 Effects of Nontarget Species Consumption of ORVAC Baits on Program
Effectiveness

2.2.8 Potential Impacts to Indian Trust Resources

2.2.9 Potential for Adverse Impacts on Lightscape

2.2.10 Potential for Adverse Impacts on Soundscape

2.2.11 Potential for Adverse Impacts to Historical Properties

2.2.12 Potential for Adverse Impacts to Minority and Low-Income
Populations

2.2.13 Potential for Adverse Impacts to the Safety and Health of
Children

**3.0 CHAPTER 3: ALTERNATIVES**

3.1 ALTERNATIVES CONSIDERED, INCLUDING THE PROPOSED ACTION

> 3.1.1 Alternative 1. Authorize an ORVAC Program - Proposed action
> (*this is the preferred alternative*)
>
> 3.1.2 Alternative 2. No action

3.2 ALTERNATIVES DISMISSED FROM FURTHER ANALYSIS

> 3.2.1 An ORVAC program with animal specimen collections for monitoring
> purposes
>
> 3.2.2 Live-capture-vaccinate-release programs
>
> 3.2.3 Depopulation of raccoons
>
> 3.2.4 Employ other types of ORVAC instead of the V-RG vaccine

3.3 MITIGATION IN STANDARD OPERATING PROCEDURES FOR RABIES ORVAC
PROGRAMS

3.4 ENVIRONMENTALLY PREFERRED ALTERNATIVE

**4.0 CHAPTER 4: AFFECTED ENVIRONMENT**

4.1 Potentially Affected NPS Units in the Eastern Rivers and Mountains
Network Parks Grouping

**5.0 CHAPTER 5: ENVIRONMENTAL CONSEQUENCES**

5.1 Potential for Adverse Effects on People that become Exposed to the
Vaccine or the Baits

5.2 Effects of the ORVAC V-RG Vaccine on Raccoons

5.3 Potential for Adverse Effects on Nontarget Wildlife Species,
including Threatened or Endangered Species

5.4 Potential for Adverse Effects on Pet Dogs or Other Domestic Animals
that might Consume the Baits

5.5 Potential for the Recombined V-RG Virus to "Revert to Virulence" and
Result in a Virus that could Cause Disease in Humans or Animals

5.6 Potential for the RABORAL V-RG® Vaccine to Recombine with Other
Viruses in the Wild to form New Viruses that could Cause Disease in
Humans or Animals

5.7 Potential for Aerially Dropped Baits to Strike and Injure People or
Domestic Animals

5.8 Potential Impacts on Visitor Use/Experience

**APPENDICES**

Appendix A List of Preparers, Reviewers, and Persons/Agencies Consulted

Appendix B Literature Cited

Appendix C Species Listed as Threatened or Endangered in the States of
Pennsylvania, New Jersey, and West Virginia under the Federal Endangered
Species Act

> Appendix D Species Listed as Threatened, Endangered, or Special Status
> under State Laws in Pennsylvania, New Jersey, and West Virginia

Appendix E Ecoregion Designations within States Involved in ORVAC
Programs

**FIGURES AND TABLES**

Figure 1-1 Potential areas of the U.S. into which raccoon rabies could
spread if not stopped by rabies management programs.

Figure 1-2

A and B A (Left): Fishmeal polymer and B (Right): coated sachet baits
utilized during the National ORVAC program. (Photos used with permission
from MERIAL Limited, Athens, Georgia, USA).

Figure 1-3 The Network Parks system in the NE Region of the NPS.

Figure 1-4

A and B A (Left): Current oral rabies vaccination barrier zones in the
U.S. B (Right): ORVAC baits would be distributed on NPS units (green)
within the states shaded in yellow under the proposed action to
vaccinate wild raccoons and form barriers to halt further spread of the
disease.

Table 3-1 Comparative summary of environmental impacts

Table 3-2 Comparative summary of alternatives and extent to which each
alternative meets the project objectives

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**1.0 CHAPTER 1: PURPOSE OF AND NEED FOR ACTION**

[]{.mark}

**1.1 BACKGROUND**

**1.1.1 Introduction**

Rabies is an acute, fatal viral disease of mammals most often
transmitted through the bite of a rabid animal. The earliest records
suggest rabies was present in dogs about 2300 B.C., but the disease
probably evolved before recorded history. Despite its long coexistence
with humans, rabies is a public and animal health problem that annually
results in 50,000 to 70,000 deaths a year worldwide. Up until 1960, most
cases of rabies in the United States were reported in dogs. However, the
combination of public education and vaccination programs for companion
dogs has controlled rabies in dogs. The disease can be effectively
prevented in humans and many domestic animal species, but abundant and
widely distributed reservoirs among wild mammals complicate rabies
control. Within most of the U.S., these reservoirs occur in
geographically discrete regions where the virus transmission is
primarily between members of the same species (Krebs et al. 2000). These
species include but are not limited to raccoons (*Procyon lotor*),
coyotes (*Canis latrans*), skunks (primarily *Mephitis mephitis*), gray
foxes (*Urocyon cinereoargenteus*), and red foxes (*Vulpes vulpes*).
Species specific variants of the virus may be transmitted to other
animal species. However these encounters rarely result in sustained
virus transmission within that animal species. Once established, virus
transmission within a specific animal species can persist at epidemic
levels for decades, even perhaps for centuries (Krebs et al. 2000).

The vast majority of rabies cases reported to the Centers for Disease
Control and Prevention (CDC) each year occur in raccoons, skunks, and
bats (Order *Chiroptera*). Red foxes account for less than 10 percent of
the reported rabies cases, with domestic cats, dogs and cattle among
those most often reported (CDC 2001a). Two canine rabies epidemics
emerged in Texas in 1988, one involving coyotes and dogs in South Texas
and the other in gray foxes in West/Central Texas. The South Texas
epidemic alone has resulted in two human deaths and caused over 3,000
people to receive postexposure rabies treatment (TDH 2004).

**1.1.2 Public Health Importance of Rabies**

Over the last 100 years, rabies in the U.S. has changed dramatically.
About 90 percent or greater of all animal cases reported annually to CDC
now occur in wildlife (Krebs et al. 2000, CDC 2001a). 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 U.S. has declined from more than 100
annually at the turn of the century to an average of one or two
people/year in the 1990s. Modern day prophylaxis, which is the series of
vaccine injections given to people who have been potentially or actually
exposed, has proven nearly 100 percent successful in preventing
mortality when administered promptly (CDC 2001a). In the U.S., human
fatalities associated with rabies occur in people who fail to seek
timely medical assistance, usually because they were unaware of their
exposure to rabies.

Although human rabies deaths are rare, the estimated public health costs
associated with disease detection, prevention, and control have risen,
and are estimated to exceed \$300 to \$450 million annually. These costs
include the vaccination of companion animals, maintenance of rabies
laboratories, medical costs, such as those incurred for exposure case
investigations, rabies post-exposure prophylaxis (PEP) and animal
control programs (CDC 2001a). In addition, each year tens of thousands
of people are impacted by anxiety, fear, and trauma associated with
potential or actual rabies exposure to themselves and their domestic
animals. Exclusion, proper storage and disposal of garbage, and removal
of problem animals are often effective alternatives to address wildlife
rabies threats at specific sites; however, oral rabies vaccination
(ORVAC) is the only currently available technique that shows promise for
wildlife rabies control on a broad geographic and species scale (Slate
et al. 2002).

Accurate estimates of these expenditures are not available. Although the
number of PEPs given in the U.S. each year is unknown, it is estimated
to be about 40,000. When rabies becomes epidemic or prevalent in a
region, the number of PEPs 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 (CDC 2001a) and has
been reported to be as high as \$3,000 or more (Meltzer 1996). In
Massachusetts during 1991-95, the median cost for PEP was \$2,376 per
person (CDC 2001b). Also, as epidemics spread in wildlife populations,
the risk of "mass" human exposures requiring treatment of large numbers
of people that contact individual rabid domestic animals infected by
wild rabid animals increases. One case in Massachusetts involving
contact with, or drinking milk from, a single rabid cow required PEPs
for a total of 71 persons (CDC 2001b). The total cost of this single
incident exceeded \$160,000 based on the median cost for PEPs in that
state. Perhaps the most expensive single mass exposure case on record in
the U.S. occurred in 1994 when a kitten from a pet store in Concord, NH
tested positive for rabies after a brief illness. As a result of
potential exposure to this kitten or to other potentially rabid animals
in the store, at least 665 persons received postexposure rabies
vaccinations at a total cost of more than \$1.1 million (Noah et al.
1995).

**1.1.3 Raccoon Rabies in the Eastern U.S.**

Epizootic rabies among raccoons in the U.S. was first identified in
Florida in the 1940s and, therefore, is considered an exotic strain in
the U.S. outside this area (C. Rupprecht, CDC, pers. comm. 2003). The
affected area gradually expanded into other southeastern states. In the
late 1970s, a second focus of rabies among raccoons emerged on the West
Virginia/Virginia border (Childs et al. 2000, Krebs et al. 2002).
Raccoon rabies was first introduced to the mid-Atlantic region of the
U.S. with the translocation of infected raccoons from Florida to Hardy
County, WV and Shenandoah County, VA in 1978 and 1979 (Nettles et al.
1979). From these counties, the disease spread rapidly along the east
coast and has now become enzootic[^1] in all of the east coast states as
well as Alabama, Pennsylvania, Vermont, West Virginia, and eastern Ohio
(Krebs et al. 2000).

[]{.mark}

Epizootiologic and virologic investigations indicated this new focus in
the mid-Atlantic region resulted from the translocation of raccoons
incubating rabies from the southeastern U.S. The epizootic front of the
mid-Atlantic outbreak has progressed in a primarily northeasterly
direction at a rate of 30-47 km/year. The northern extension of this
epizootic reached Canada in 1999 with its first three cases of raccoon
rabies confirmed in southern Ontario (Rosatte et al. 2001) and the
strain has recently been reported in New Brunswick. To the south, the
once separate epizootics of raccoon rabies in the mid-Atlantic and
southeastern states converged in North Carolina in 1994 (Childs et al.
2000, Krebs et al. 2002). The epizootic of rabies involving raccoons
that developed in the mid-Atlantic region is one of the largest
documented outbreaks in the history of wildlife rabies. More than 50,000
cases of rabies among raccoons in eastern states have been reported to
the CDC since 1980 (Childs et al. 2000). In most southeastern and
mid-Atlantic states, raccoons account for the largest proportion of
laboratory-confirmed rabid animals (Woodruff et al. 1991). Most human
exposures from rabid raccoons and other wild animals involve animals
encountered in the wild. In addition, exposures to rabid wild animals
kept as pets have also been documented (Woodruff et al. 1991).

The 1983 arrival of the mid-Atlantic rabies epizootic in raccoons in
Washington, D.C. raised interest in raccoon and disease ecology in urban
areas, particularly because of the high densities of both humans and
raccoons and the increased possibility of transmission of disease from
raccoons to humans or domestic animals (Riley et al. 1998). For
instance, raccoon density in Rock Creek National Park in Washington,
D.C. was from twice to more than 100 times (333.3 to 66.7 raccoons per
sq. km) that reported for the species in non-urban habitats and was
consistent with the few estimates published for other urban and suburban
raccoon populations (Riley et al. 1998). Researchers in urban and
suburban areas have found that dense populations of raccoons are more
likely to be subject to epizootics of contact diseases such as rabies
and canine distemper and may be more likely to continue to harbor a
disease after the initial epizootic (Riley et al. 1998). Dense raccoon
populations in close proximity to high-density human populations may
represent a public health threat as reservoirs of parasites and
diseases. For these reasons, management of urban and suburban raccoon
populations often is warranted (Prange et al. 2003).

The number of reported cases of rabies among wild and domestic animals
increases in summer when people, especially children, are outdoors more
often and are, therefore, more likely to come into contact with a rabid
animal (Beck 1984). In the U.S., dog-to-dog rabies transmission is rare.
Most cases of rabies in dogs and other domestic animals has been
reported from areas where rabies is found among wildlife, particularly
foxes, skunks, and raccoons (Beck 1984). In the mid-Atlantic outbreak,
nine domestic animals had been exposed to 247 rabid raccoons,
documenting the importance of the present raccoon problem. Raccoons are
a greater threat to dogs and, therefore, people, than skunks, foxes, or
bats, even though there are more cases nationwide of rabies among the
latter three (Beck 1984). Raccoons are a threat because they thrive in
urban and suburban areas, can make use of the human habitats, and are
considered by many people to be more "tolerable" than skunks and foxes
(Beck 1984). In fact, the CDC reported that raccoons accounted for
almost 40 percent of the 7,437 cases of rabies that were reported in the
U.S. in 2001 (CDC website: [http://www.cdc.gov](http://www.cdc.gov/)).

The director of the CDC has indicated that raccoon rabies presents a
serious public health problem in the U.S. (letter to APHIS-WS, dated May
29, 2001). Potential direct exposure to rabid raccoons, or indirect
exposure by a pet that had an encounter with a rabid raccoon, creates
this human health threat. To date, one case resulting in the death of a
human is attributable to the raccoon strain of the rabies virus. A
25-year-old, previously healthy northern Virginia man died in June 2003.
A diagnosis of rabies had not been considered and was only made 3 months
after death when brain tissue was examined. Patient history did not
reveal contact with animals and no specific exposure experience could be
determined (S. Jenkins, Virginia Department of Health, pers. comm. 2003;
L. Orciari, CDC, pers. comm. 2003). Raccoon rabies also increases health
care costs. The number of pets and livestock examined and vaccinated for
rabies, the number of diagnostic tests requested, and the number of post
exposure treatments which are all greater when raccoon rabies is present
in an area. Human and financial resources allocated to rabies-related
human and animal health needs therefore increase, often at the expense
of other important activities and services.

In situations where diseases like West Nile Virus, Lyme disease,
Hantavirus, and Raccoon Rabies, could affect the resources, visitors,
and employees, the NPS is directed to look to the U.S. Public Health
Service and CDC for guidance. The Management Policies for the NPS state,
"for the removal of an exotic species that is already present in a park,
all exotic plants and animals that are not maintained to meet an
identified park purpose will be managed, up to and including
eradication, if (1) control is prudent and feasible, and (2) the exotic
species "...poses a public health hazard as advised by the U.S. Public
Health Service (which includes the CDC and the NPS Public Health
Program) and/or creates a hazard to public safety." For management
consideration, the raccoon rabies virus has been determined by the CDC
to be exotic to the Northeastern United States. The NPS Public Health
Program concurs with the CDC assessment that rabies is a significant
public health risk and that every reasonable effort should be made to
control the disease (M. Wild, NPS, pers. comm. 2004).

The westward and northward movement of the raccoon rabies front has
slowed, probably in response to both natural geographic and man-made
barriers. The Appalachian Mountains and perhaps river systems flowing
eastward have helped confine the raccoon variant to the eastern U.S. In
northeast Ohio, an oral rabies vaccination (ORVAC) program has
established an "immune barrier" along its border with Pennsylvania from
Lake Erie to the Ohio River near East Liverpool, Ohio that has slowed if
not stopped the westward expansion of raccoon rabies. If raccoon rabies
breaches this barrier, current live trapping results in Ohio (A.
Montoney, APHIS-WS, pers. comm. cited in Kemere et al. 2001) as well as
the status of raccoons in the Midwest (Sanderson and Hubert 1982, Glueck
et al. 1988, Hasbrouck et al. 1992, Mosillo et al. 1999) suggest that
raccoon populations are sufficient for rabies to spread westward along a
front at a rate similar to or greater (Rupprecht and Smith 1994) than
the rate at which this rabies strain has spread in the eastern U.S.
Figure 1-1 shows the potential for spread of this rabies variant across
the central portion of the U.S. if it is not stopped.

> ![](media/image3.wmf){width="4.2375in" height="2.3673611111111112in"}

**1.1.4 Development of ORVAC and ORVAC Baits**

Although the concept of ORVAC to control rabies in free ranging wildlife
populations originated in the U.S. (Baer 1988), it has a longer history
of implementation in Europe and Canada. The implementation of ORVAC
programs in several Western European countries using either attenuated
rabies vaccines or the recombinant Raboral V-RG® have resulted in
several European countries being designated free of rabies (Slate et al.
2002). In North America, the Province of Ontario, Canada expanded
research during the mid-1970s to evaluate the prospect of using ORVAC to
eliminate rabies that became established in red foxes in the southern
part of the Province during the last 1950s. Since 1989, the Ontario
Ministry of Natural Resources has aerially distributed about 12 million
baits containing an attenuated rabies virus (ERA vaccine) that has
reduced rabies in foxes by more than 97 percent (Slate et al. 2002).

The emergence of raccoon rabies in the U.S. during the 1970s heightened
interest in the application of ORVAC to raccoons. Due to biological and
ecological differences among the types of animals that transmit rabies,
development of specific vaccine and bait combinations was needed. 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 ORVAC programs in Europe and Canada, raccoons were not
readily immunized by the oral route with the modified "live virus"
vaccines that worked well in foxes (Rupprecht et al. 1988). Furthermore,
modified "live virus" vaccines pose a small risk of causing
vaccine-induced rabies, and have resulted in some cases of
vaccine-induced rabies in animals (but no cases in humans) during oral
baiting programs in Europe and Canada (Wandeler 1991).

As a consequence of field safety testing in the early 1990's, a
vaccinia-rabies glycoprotein (V-RG) vaccine was conditionally U.S.
Department of Agriculture (USDA) licensed for vaccination of
free-ranging raccoons in 1995 and fully licensed in 1997 in the U.S.
(Hanlon et al. 1999). It remains the only effective vaccine licensed for
use in the U.S. and Canada for raccoons (CDC 2000). V-RG was also
recently licensed by the USDA in 2002 for vaccination of coyotes in the
U.S. and Canada (although it is only being used for raccoons in Canada,
as canine rabies has not been found in coyotes in Canada). It has also
been approved for experimental use by USDA, Animal and Plant Health
Inspection Service (APHIS), Veterinary Services (VS), Center of
Veterinary Biologics for vaccination of free-ranging wild gray foxes in
Texas (CDC 2001a, Hanlon et al. 1999).

The V-RG vaccine has proven to be orally effective in raccoons, coyotes
and foxes (USDA 2001a, Oertli et al. 2002). This vaccine was extensively
laboratory-tested for safety in more than 50 animal species with no
adverse effects regardless of route or dose (Rupprecht et al. 1992a). In
addition, a domestic animal's annual rabies vaccination can be safely
administered even if it recently ingested a dose of oral rabies vaccine
(Oertli et al. 2002).

The vaccinia-rabies glycoprotein vaccine used by the ORVAC program is
commercially available from MERIAL, 115 Transtech Drive, Athens, GA
30601 under the registered name RABORAL V-RG®. Throughout the remainder
of this document, RABORAL V-RG® is referred to as "V-RG". As a
recombinant vaccine, the letter "V" is used to denote vaccinia, the
self-replicating pox virus that serves as the vector (i.e., carrier) for
the rabies virus gene that is responsible for the production of rabies
glycoprotein. The letters "RG" stand for rabies glycoprotein which is
the protective sheath around the bullet-shaped rabies virus core. The
glycoprotein by itself is non-infective and cannot cause rabies, but it
serves as an "antigen" which means it elicits an immune response to
rabies when the vaccine is swallowed by raccoons, foxes, or coyotes.
There is no possibility of vaccine-induced rabies with V-RG because the
vaccine only contains the non-infective surface protein of the rabies
virus; none of the viral nuclear material (i.e., RNA) which would be
required for the rabies virus to replicate is present in the vaccine.
Approximately 43.75 million doses have been distributed in the U.S.
since 1995 with only one case of vaccinia virus infection reported in
humans (resulting in localized skin rashes) to date (Rupprecht et al.
*unpublished* 2000, Rupprecht et al. 2001).

A number of studies have been conducted to determine the best bait
formulations and strategies for delivery of ORVAC vaccines to raccoons
(Hanlon et al. 1989a, Hable et al. 1992, Hadidian et al. 1989, Linhart
et al. 1991, Linhart et al. 1994). When raccoons eat oral rabies baits
and puncture a sachet[^2] containing the vaccine, the vaccine is
swallowed and bathes the lymphatic tissue in the throat area and
initiates the immunization process.

A positive rabies antibody titer in an animal from a baited area is most
likely due to consumption of a bait and adequate contact with vaccine.
However, the lack of a detectable antibody response may not be an
accurate reflection of immune status. It is possible that the animal was
successfully immunized, but that the blood sample was taken earlier or
later than when antibodies could be detected (C. Hanlon, CDC, pers.
comm. 2003). Antibodies induced by a one-time oral vaccination appear to
be of relatively short duration. Among a group of animals in a baited
area, the best time to collect blood samples for detection of antibodies
is 4-8 weeks after baiting. A successfully immunized animal may have
antibodies shortly after vaccination, but then the level may decline to
undetectable levels. If the animal is then exposed to rabies, it is
still likely that the animal\'s \"memory\" immunity will become
activated by the rabies exposure and more antibodies will be made very
quickly. The successfully immunized animal will most likely survive
exposure, even though it did not have measurable antibodies at the time
of the exposure (C. Hanlon, CDC, pers. comm. 2003).

The baits are small blocks of fishmeal that are held together with a
polymer binding agent and are considered to be "food grade" materials
(Figure 1-2). The baits are rectangular or square in shape with hollow
centers. The sachet containing the liquid vaccine is contained in the
hollow center of the bait. The sachet is composed of a thin plastic
material that is not readily digested by the animal ingesting the bait
and is subsequently passed through the animal's digestive tract.
"Coated" sachets with a simple fishmeal attractant coating have also
been field tested with effectiveness that appears to be comparable to
fishmeal polymer baits containing the sachet (Linhart et al.
*unpublished* 2001). Using the "coated" sachet may be equal in
effectiveness at lower cost per vaccinated target wild animal. All baits
are marked with a warning label that includes a phone number to call for
additional information.

![](media/image4.jpeg){width="2.2090277777777776in"
height="1.7083333333333333in"}![](media/image5.jpeg){width="2.3743055555555554in"
height="1.6979166666666667in"}

**Figure 1-2. A (Left): Fishmeal polymer and B (Right): coated sachet
baits utilized during the National ORVAC program. (Photos used with
permission from MERIAL Limited, Athens, Georgia, USA).**

Cornell University recently conducted a study (USDA 2004a) comparing the
performance of the coated sachet to fishmeal polymer baits for
delivering oral rabies vaccine in the wild. Results from this study,
along with those from captive studies being conducted by the APHIS-WS,
National Wildlife Research Center, are critical to decisions regarding
the best available bait for delivering oral rabies vaccine to raccoons.
Preliminary results, yet to be published by Cornell, suggest that the
coated sachet performs at least as good as fishmeal polymer bait and
often exceeds its performance. Generally higher performance at a lower
cost (approximately 20 percent less than fishmeal polymer baits), plus
the lower risk of damage from aerial bait distribution, make the coated
sachet a good interim bait option while other baits are evaluated for
safety and efficacy.

Fishmeal polymer baits contain a tetracycline biomarker. These
biomarkers bind to calcium, which can be found in the metabolically
active portions of bones and teeth of animals. Tetracycline deposits can
be viewed in the teeth or bones with fluorescent light under a
microscope. When the tooth or bone sample of an animal is positive for
tetracycline, it is likely that the animal has eaten at least one bait
and possibly multiple baits (C. Hanlon, CDC, pers. comm. 2003). The
presence of tetracycline, however, is not an indication of immunity
since it is possible in some situations for an animal to eat the outer
bait matrix without rupturing the vaccine sachet inside. Other potential
sources of \"background\" tetracycline in a study area may include
consumption of medicated feeds such as those sometimes used for
production animals, intentional treatment by humans with tetracycline,
and non-specific fluorescence from undescribed but similar chemical
compounds that may be found naturally (C. Hanlon, CDC, pers. comm.
2003).

In field tests conducted in the U.S., the majority of ORVAC baits have
been consumed within the first 7 to 14 days after placement, with
reports of up to 100 percent of the baits being consumed within a 7 day
period (Farry et al. 1998a and 1998b, Hable et al. 1992, Hadidian et al.
1989, Hanlon et al. 1989a, Linhart et al. 1994, Steelman et al. 2000,
USDA 1995a). The likelihood of a bait being consumed is dependent upon
several factors including animal population densities (target and
nontarget species), bait preference, and the availability of alternative
food sources. Those baits that are not consumed may remain in the
environment for several months after placement dependent upon
environmental conditions (precipitation, temperature, etc.) and the
condition of the baits. The V-RG virus that is not consumed by the
target species or other vertebrates will become inactivated over a
relatively short time period. Persistence and stability of the V-RG
virus outside of an organism is highly dependent on ambient temperature
and local environmental conditions, the higher the temperature the
quicker the virus will become inactive (USDA 1992, 1995a). For example,
at temperatures between 68 and 100 degrees Fahrenheit the liquid viral
vaccine potency remains stable for approximately 14 and 7 days,
respectively, in the un-punctured sachet or inside the bait. In
situations where the bait and sachet are damaged inactivation of the
V-RG virus will occur more rapidly.

**1.1.5 Development of ORVAC Programs in the United States**

Oral wildlife vaccination for rabies control has been under field
evaluation in the U.S. since 1990. At that time a limited field release
of the recombinant vaccine occurred on Parramore Island, VA to evaluate
the potential effects that V-RG baits may have on free-ranging raccoon
populations (Hanlon et al. 1998). As a result of this field trial and
subsequent trials elsewhere an effective V-RG has been developed to
control species specific rabies variants to complement other methods of
rabies prevention and control including public education, domestic
animal vaccination, and human PEP. In 2005, APHIS-WS, in cooperation
with the CDC, will begin conducting small mammal vaccinia monitoring at
Parramore Island, VA. Because this is the site where vaccinia was first
released into the wild in ORVAC baits and since these baits have not
been released at this site since the early 1990s, viruses in hosts can
be monitored. Microtine mammals, especially rodents, are typically the
most likely hosts for orthopox viruses, which include vaccinia. Thus,
these mammals are good sentinel species for indicators for the
environmental presence of viruses, such as vaccinia. Samples will be
collected and tested at CDC laboratories to determine the presence of
vaccinia virus in small mammals collected at this site. Current plans
involve conducting similar sampling and testing of small mammals at Plum
Brook, OH in the near future for vaccinia surveillance.

Since the first field release of the V-RG vaccine in 1990, the number of
vaccine-laden baits that were distributed annually in the U.S. has risen
exponentially. For instance, APHIS-WS' involvement in the national
rabies management program between 1995 and 2003 contributed to 43.75
million ORVAC baits disbursed in the U.S (USDA 2004c). Numerous projects
have been conducted or are in progress in the eastern U.S. and Texas
(USDA 2004a, 2004c). Since ORVAC program inception, positive rabies
cases have either decreased or the advance of the virus has been slowed
or stopped in each state where an ORVAC program was initiated:

-   In Maryland, 18 rabies cases were reported per year on the Annapolis
    Peninsula alone before the ORVAC program began in 1998. From
    2000-2002 and 2003, Maryland reported zero cases and one case,
    respectively (USDA 2004a, 2004c).

-   In New York, an ORVAC program was implemented in 1998 to prevent the
    northward spread of the virus. Prior to the ORVAC program in New
    York, almost 150 positive rabies cases were recorded in 1998
    and 1999. In 2002, New York reported a decline to 4 positive rabies
    cases, of which only one was attributed to a raccoon, and zero cases
    have been reported since (USDA 2004a, 2004c). A recently completed
    project in Albany and Rensselaer Counties of New York State
    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 ORVAC.

> In late August, 2004, APHIS-WS initiated a cooperative emergency
> rabies surveillance and control program on Long Island (Nassau County)
> in cooperation with the New York State Department of Health (NYSDOH),
> Agriculture and Markets, Department of Environmental Conservation and
> the Nassau County Department of Health. The program included enhanced
> surveillance to better document the location and scope of a recent
> rabies outbreak and vaccination of raccoons to prevent the further
> spread of rabies. As a result of enhanced surveillance efforts, seven
> raccoons were confirmed to have the raccoon strain of rabies in Nassau
> County. More than 350 raccoons were trapped and submitted for testing
> within a 2 mile radius of the index case. This is the first time
> raccoon rabies has been documented on Long Island. Two types of
> vaccination programs were implemented in September, 2004 on Long
> Island by APHIS-WS and NYSDOH, including raccoon
> trap-vaccinate-release (more than 400 raccoons vaccinated) and ORVAC
> programs where 11,000 coated sachet baits were distributed by New York
> State police helicopters and 10,000 fishmeal polymer baits were
> distributed by hand in a zone around the positive cases. The
> contingency effort on Long Island focused on creating a rabies-immune
> raccoon population in the target zone to prevent additional cases.
> High densities of raccoons on Long Island make it more likely for a
> human, pet, or other domestic animal to encounter a rabid raccoon;
> thus the spread of raccoon rabies is of great concern. Enhanced
> surveillance and vaccination of raccoons will greatly decrease the
> chance of human and domestic animal contact with rabid raccoons (R.
> Chipman, APHIS-WS, pers. comm. 2004).

-   In Vermont, before the program was started in 1996, positive rabies
    cases were found 73 km. (45.5 miles) south of the Quebec, Canada
    border. With an annual rate of spread of rabies at 56.3 km/year (35
    miles/year), positive raccoon strain rabies cases should have
    reached the Canada border as early as 1999. However, the border has
    not yet been breached (USDA 2004a, 2004c). Annual vaccination
    projects in the Lake Champlain Valley in Vermont and New York have
    shown promise in preventing the northward spread of raccoon rabies.
    Raccoon rabies has moved through much of the St. Lawrence River
    Valley in northern New York with the appearance of two raccoon
    rabies foci (i.e., point locations of rabies cases) in southern
    Ontario. Cooperative efforts with Ontario and the implementation of
    point infection control strategies in Ontario around these foci are
    under evaluation to determine if the raccoon variant of the rabies
    virus can be contained and eliminated (L. Bigler, pers. comm. 2001).

[]{.mark}

-   In Ohio, 62 positive rabies cases were recorded prior to program
    implementation in 1997. From 2001-2003, three cases were reported
    near the Pennsylvania border where raccoon rabies is still enzootic.
    In 2001, APHIS-WS, in coordination with state agencies, began an
    ORVAC program in Pennsylvania (USDA 2004a, 2004c) to address this
    issue. The ability to create rabies-free zones, within raccoon
    rabies enzootic areas, is a requisite to achieve elimination of this
    variant of the rabies virus.

> In mid-July 2004, a raccoon infected with raccoon variant of the
> rabies virus was confirmed just west of the ORVAC zone near Lake Erie
> in Lake County in northeastern Ohio. This cooperative ORVAC project
> began in 1997 and has expanded to include the states of Pennsylvania,
> West Virginia, Virginia, Tennessee, Maryland, Georgia and Alabama.
> Throughout its length from Ohio to northeastern Alabama, the ORVAC
> zone is at least 30-miles in width to attempt to prevent the westward
> spread of raccoon rabies. APHIS-WS and state, county and municipal
> cooperators responded immediately to this high priority rabies issue.
> A contingency action plan that included enhanced rabies surveillance,
> trap-vaccinate-release, and ORVAC was implemented upon detection of
> the index case. High raccoon population densities and additional
> rabies cases based on enhanced surveillance suggest that additional
> action may be required. Enhanced rabies surveillance is being
> maintained on the south and west sides of this outbreak to determine
> the next course of action, if required.

-   In Massachusetts, the rabies virus had not spread to Cape Cod where
    intensive baiting programs at the peninsular neck (since 1995),
    combined with the natural barrier of Cape Cod Canal, seemed to act
    as effective barriers (Robbins et al. 1998). In early March 2004,
    however, raccoon variant of the rabies virus was confirmed east of
    the Cape Cod Canal for the first time. The canal served as the
    eastern anchor point for the ORVAC zone which was designed to
    prevent raccoon rabies from spreading east onto the Cape. This
    cooperative project was initiated in the mid-1990s by Tufts
    University and the State of Massachusetts Health Department.
    APHIS-WS became a partner in this effort in 2001. APHIS-WS, Tufts
    University, and the State of Massachusetts Health Department
    immediately implemented enhanced rabies surveillance, followed by
    trap-vaccinate-release, and ORVAC as a contingency action plan to
    prevent further spread, with the long range goal of eliminating
    raccoon rabies from the area. It is not known if raccoon rabies
    spread to the Cape through the long range movement of an individual
    rabid raccoon, or skunk infected with raccoon variant of the rabies
    virus, or if the virus spread animal to animal approaching the
    canal, with rabies spreading to the Cape through a short range
    raccoon or skunk movement across the canal. Translocation, either
    intentional or unintentional (i.e., raccoon "hitch-hiking" in a
    garbage truck or tailored boat and escaping once on the Cape),
    represents another other potential source of spread.

-   In June 2003, the rabies front, which had stalled in North Carolina,
    finally moved west and crossed over the Appalachians into upper east
    Tennessee (6 raccoon strain cases were reported). In attempt to stay
    ahead of the rabies front, APHIS-WS extended the ORVAC baiting area
    into Tennessee (USDA 2004a, 2004c).

-   Since 1995, 9.35 million vaccine-laden baits have been distributed
    in south Texas in an ORVAC program that has proved to be highly
    effective in the elimination of the coyote rabies strain in that
    area. Prior to the ORVAC program, 166 canine strain rabies cases
    were reported in Texas. One case was reported in 2001 along the
    Texas-Mexico border and zero cases have been reported since. Similar
    success is sought in the gray fox epizootic in west-central Texas
    where 10.6 million vaccine-laden baits have been distributed. In
    2002, 18 positive cases of gray fox strain rabies occurred outside
    the barrier, possibly due to an interrupted baiting program in 2000
    and 2001 as a result of a lack of funding. Increased funding was
    provided for the 2003 gray fox ORVAC program in Texas in order to
    encircle the zone where positive cases have been reported and
    blanket the area (USDA 2004a, 2004c).

-   Projects have also been conducted or are in progress in New Jersey
    (2003-present), Florida (1995-present), Virginia (2000-present),
    West Virginia (2001-present), Pennsylvania (1995-present), New
    Hampshire (2002-present), Alabama (2003-present), Georgia
    (2003-present), Maine (2003-present), Kentucky (2003-present),
    Louisiana (2003-present), and Mississippi (2003-present).

[]{.mark}

The challenge for successful elimination of raccoon rabies in the U.S.
involves cooperation by numerous states and land managers. Single states
within the larger enzootic zones cannot proceed with elimination
programs in isolation. Re-invasion from neighboring states will always
be a risk unless all programs are coordinated carefully. In Germany,
elimination of fox rabies has progressed slowly, at least partly because
the individual states did not act in concert. In France, which had a
national program, elimination occurred within 5 years. The challenge in
North America concerning raccoon rabies is to achieve cooperation and
coordination between two or more levels of government in two countries
(MacInnes and LeBer 2000). The use of oral vaccination in Switzerland
during the past 20 years resulted in a declaration of rabies-free status
in 1998. A similar declaration was made by France as of the end of 2000
(Krebs et al. 2002).

**1.2 DESCRIPTION AND PURPOSE OF THE PROPOSED PROGRAM**

The proposed program would distribute ORVAC baits in three states (PA,
NJ, and WV) located within the Northeast Region of The U.S. Department
of the Interior (USDI), National Park Service (NPS). The NPS units that
could potentially be affected include several of the Northeast Region's
Eastern Rivers and Mountains Network Parks:

[]{.mark}

-   Allegheny Portage Railroad National Historic Site, PA

-   Delaware Water Gap National Recreation Area, PA & NJ

-   Fort Necessity National Battlefield, PA

-   Friendship Hill National Historic Site, PA

-   Johnstown Flood National Memorial, PA

-   Bluestone National Scenic River, WV

-   Gauley River National Recreation Area, WV

-   New River Gorge National River, WV

The networks, or groupings of parks, were established by the NPS to
monitor ecological communities in its parks. The broad-based
scientifically sound information obtained through long term natural
resource monitoring will have multiple applications for management
decision-making, research, education, and promoting public understanding
of park resources
([http://www1.nature.nps.gov/protectingrestoring/im/inventoryand
monitoring.htm](http://www1.nature.nps.gov/protectingrestoring/im/inventoryand monitoring.htm)).
The four networks found in the Northeast Region of the NPS are the
Eastern Rivers and Mountains, Mid-Atlantic, Northeast Temperate, and
Northeast Coastal and Barrier (Figure 1-3). The parks included in each
of these networks are found in similar ecological communities, but are
not necessarily close together. The NPS determined these networks should
also be used to group parks for the purposes of implementing the ORVAC
program.

![](media/image6.png){width="4.365277777777778in"
height="2.854861111111111in"}

The inclusion of land areas managed by the federal government has become
an increasingly important requirement for this program, given the
extensive public lands within the ORVAC targeted zones (J.P. Koplan,
M.D., Director, CDC, pers. comm. 2001). Therefore, participation by
these NPS units is necessary to support and cooperate with the involved
state agencies and the USDA, APHIS-Wildlife Services (APHIS-WS) in their
ongoing efforts of eliminating or stopping the westward and northward
spread of raccoon rabies in the eastern U.S. and in reducing the
incidence of rabies cases involving wild and domestic animals and rabies
exposures to humans by approving ORVAC programs on NPS-managed lands.
Currently, cooperative rabies vaccination programs are already being
conducted on various land classes in each of the aforementioned states
in addition to numerous other states in the eastern U.S. (Figure 1-4).
By participating, the NPS would aid in enhancing the effectiveness of
the national program. If baiting programs were conducted around these
large land masses, reservoirs of the virus would likely still exist,
creating holes in the program and potentially making the program less
effective at stopping the forward advance or eliminating the raccoon
strain of the rabies virus.

![](media/image7.wmf){width="2.625in" height="2.4625in"}

**Figure 1-4 A and B. A (Left): Current oral rabies vaccination barrier
zones in the U.S. B (Right): ORVAC baits would be distributed on NPS
units (green) within the states shaded in yellow under the proposed
action to vaccinate wild raccoons and form barriers to halt further
spread of the disease.**

Currently, the rabies management program has no plans to implement an
ORVAC program on many of the NPS units listed in the proposed action.
However, as a result of the potential for outbreaks such as the current
outbreak in positive raccoon strain rabies cases on Long Island and
recent breaches of positive raccoon strain rabies past the ORVAC barrier
in OH and Cape Cod, MA, it is important to include all park units that
could potentially be baited in this EA. If the park units are included
now, the national rabies program will be prepared to bait if/when an
emergency situation or outbreak occurs that threatens public safety. For
the national rabies program to be effective, advance preparation and
proactiveness is essential for dealing with the possibility of outbreaks
by implementing contingency actions in the event of a public health
threat.

The Contingency Action Planning Team, part of the Rabies Management
Team, has evaluated practical alternatives to address rabies threats
that may compromise the integrity of ORVAC efforts. The team is
finalizing contingency action recommendations that may be taken if any
of the following occur (Slate et al. 2002):

-   rabies intensifies approaching an immune barrier

-   "hot spots" occur within a barrier

-   rabies breaches a barrier, but is detected just beyond the
    vaccination zone

-   rabies occurs as an isolated focus sufficiently distant from a
    barrier to suggest translocation, intentional or unintentional, was
    the source of the focus (such as with the current Long Island
    outbreak that was likely caused by "hitch-hiking" raccoons in
    garbage trucks using a landfill in the area).

Potential areas involved may cover several land types and land uses,
including: forests, meadows, wetlands, and rangelands representing
diverse wildlife habitats. The program would involve the distribution of
ORVAC baits to create zones of vaccinated target species that would then
serve as barriers to cease the further advancement of raccoon rabies
virus variants. Vaccination zones would be determined in cooperation
with several state rabies task forces and/or other agencies with
jurisdiction over vaccine use and application in wildlife and domestic
animal species. The program would involve the use of APHIS-WS federal
funds to purchase and distribute ORVAC baits.

Despite ongoing programs, the first case of raccoon rabies was confirmed
in Ontario, Canada, during July 1999. Ontario does not want raccoon
rabies and is working jointly with the U.S. to eliminate existing
reservoirs of the raccoon variant of the rabies virus and prevent the
spread of this disease into and within Canada. Efforts are underway to
prevent the disease from becoming enzootic in this province (Rosatte
2000). The national rabies management program is dedicated to preventing
additional cases from moving northward into Canada, in addition to
preventing the westward spread of the virus. Efforts to build an "immune
barrier" along the border of western Pennsylvania and eastern Ohio have
shown very positive signs. In 1997, the epizootic year for Ohio, 62
raccoon rabies case were report to State officials. After four years of
baiting, zero cases of raccoon rabies were reported in 2000. The rabies
has not been eliminated, but the number of raccoons carrying the virus
has been greatly decreased. With the successful establishment of the
immune barrier in eastern Ohio, APHIS-WS will be slowly moving the
"barrier" east into Pennsylvania, West Virginia, Virginia, Maryland, and
New York. The movement of the barrier will be slow and carefully
measured to make sure that rabies activities are declining before moving
the barrier. With generally successful results achieved with baiting for
rabies along the western front, similar results are hopeful along the
U.S. and Canada border.

The ORVAC that would be used is the V-RG vaccine. V-RG vaccine is
approved by USDA, APHIS, VS, Center of Veterinary Biologics for use on
raccoons in the U.S. and Canada. The V-RG vaccine would be encased in
fishmeal type baits. The baits weigh approximately 1 ounce and measure
11/4 x 11/4 x 3/4 inches. When an animal finds and ingests the bait, it
receives a single dose of the vaccine. 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.
Individual baits may contain a non-toxic biomarker (e.g., tetracycline)
(Johnston et al. 1987, USDA 1991). This biomarker is used to aid in
determining whether animals have eaten one or more baits for the purpose
of monitoring project effectiveness within and outside the established
ORVAC barrier zones. Each state ORVAC program collects wild animals for
monitoring purposes throughout the involved state (USDA 2001a). However,
these state programs have determined that it would not be necessary to
collect wild animals for monitoring purposes on NPS units. Therefore, no
wild animals will be collected from the aforementioned NPS units for
monitoring purposes. The NPS will use monitoring data collected by the
various state ORVAC programs on non-NPS lands surrounding the parks to
determine if program goals have been met.

On an annual basis, one treatment of ORVAC baits could be distributed by
aircraft (fixed-wing airplane or helicopter) and ground placement on the
NPS units (see list in Section 1.2). The need to distribute baits on
each of the park units would be assessed annually and based on the most
current distribution of rabies cases and the expected direction of
disease spread. The annual treatment would continue on a reoccurring
basis until the goals of the ORVAC program have been met. Baits would be
distributed at an average density of 75 per square km during the spring
and/or fall months (February 1-May 31 and/or August 15 to November 30).
Air drops would be typically conducted at about 500 feet above ground
level and would only fly momentarily over any one point on the ground
during any given bait distribution flight. The aircraft do not circle
over areas repeatedly, but fly in straight "transect" lines for purposes
of bait distribution. ORVAC baits would not be aerially distributed in
areas that are frequently used by a high volume of park visitors (i.e.,
visitor centers, campgrounds, etc.), as well as over lakes, reservoirs,
and large rivers. Aerial distribution of baits would primarily target
areas of habitat suitable for the target species. When aerial
distribution by fixed-wing or helicopter aircraft is not practical,
baits would be distributed by careful hand placement to help to minimize
contact by humans, pets and other domestic animals.

The proposed ORVAC program would be conducted in compliance with
appropriate federal, state and local laws including National Park
Service Management Policies 2001, Director's Orders, executive orders,
general environmental legislation, and other laws used to guide
management practices carried out on NPS lands.

**1.3 NEED FOR ACTION**

**1.3.1 Need for a Raccoon ORVAC Program**

If new rabies strains such as those transmitted by raccoons are not
prevented from spreading to new areas of the U.S., the health threats
and costs associated with rabies are expected to increase substantially
as broader geographic areas are affected.

***Need to protect human health and safety***

People are concerned with potential health threats and costs associated
with being exposed to a rabid animal. People are most often exposed
through a bite from a wild or domestic animal infected with the disease
(CDC 2001a). More than 90 percent of all reported animal cases occur in
wild animals (CDC 2001a). Rabies is a fatal disease in humans unless
medically treated with postexposure prophylaxis. Human health care
concerns associated with the disease would be expected to increase as
the rabies virus infects a much broader geographic area. Expansion of
ORVAC activities to include NPS units is important for providing
adequate coverage to the barrier and other outbreak areas in order to
retain program effectiveness. A more detailed description of the need to
protect humans from exposure to the rabies virus is presented in Section
1.1.2 of this environmental assessment (EA).

***Need to protect domestic animals***

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 through coastal Maine) to
the Rocky Mountains, there are more than 111 million livestock animals,
including cattle, horses, mules, swine, goats, and sheep, valued at \$42
billion (65 FR 76606-76607, December 7, 2000). Also within this area are
countless numbers of domestic animals that are kept by people as pets
(cats, dogs, rabbits, ferrets, etc). If raccoon rabies were to spread
into the above described area, many of these domestic animals would be
at risk of being exposed to this specific variant.

**1.4 AUTHORITIES**

**[Federal Authorities]{.underline}**

**National Park Service Organic Act - Act of August 25, 1916 (16 U.S.C.
1, 2, 3, and 4) and Management Policies.** By enacting the National Park
Service Organic Act of 1916 (Organic Act), Congress directed the USDI
and the NPS to manage units "to conserve the scenery and the natural and
historic objects and the wild life therein and to provide for the
enjoyment of the same in such manner and by such means as will leave
them unimpaired for the enjoyment of future genera­tions" (16 USC 1).
Congress reiterated this mandate in the **Redwood National Park
Expansion Act of 1978** by stating that the NPS must conduct its actions
in a manner that will ensure no "derogation of the values and purposes
for which these various areas have been established, except as may have
been or shall be directly and specifically provided by Congress" (16 USC
1a-1).

Despite these mandates, the Organic Act and its amendments afford the
NPS latitude when making resource decisions that balance visitor
recreation and resource preservation. By these acts Congress "empowered
\[the NPS\] with the authority to determine what uses of park resources
are proper and what proportion of the parks resources are available for
each use" (*Bicycle Trails Council of Marin v. Babbitt,* 82 F.3d 1445,
1453 (9th Cir. 1996)).

Yet, courts consistently interpreted the Organic Act and its amendments
to elevate resource conserva­tion above visitor recreation. *Michigan
United Conservation Clubs v. Lujan,* 949 F.2d 202, 206 (6th Cir. 1991)
states, "Congress placed specific emphasis on conservation." The
*National Rifle Ass'n of America v. Potter,* 628 F. Supp. 903, 909
states, "In the Organic Act Congress speaks of but a single purpose,
namely, conservation." The NPS *Management Policies 2001* (USDI 2000b)
also recognize that resource conservation takes precedence over visitor
recreation. The policy dictates "when there is a conflict between
conserving resources and values and providing for enjoyment of them,
conservation is to be predominant" (NPS *Management Policies* *2001,*
sec. 1.4.3).

Because conservation remains predominant, the NPS seeks to avoid or to
minimize adverse impacts on park resources and values. Yet, the NPS has
discretion to allow negative impacts when necessary (NPS *Management
Policies 2001,* sec. 1.4.3). While some actions and activities cause
impacts, the NPS cannot allow an adverse impact that constitutes a
resource impairment (NPS *Management Policies 2001,* sec. 1.4.3). The
Organic Act prohibits actions that permanently impair park resources
unless a law directly and specifically allows for the actions (16 USC
1a-1). An action constitutes an impairment when its impacts "harm the
integrity of park re­sources or values, including the opportunities that
otherwise would be present for the enjoyment of those resources or
values" (NPS *Management Policies 2001,* sec. 1.4.4). To determine
impairment, the NPS must evaluate "the particular resources and values
that would be affected; the severity, duration, and timing of the
impact; the direct and indirect effects of the impact; and the
cumulative effects of the impact in question and other impacts" (NPS
*Management Policies 2001,* sec. 1.4.4).

Because park units vary based on their enabling legislation, natural
resources, cultural resources, and missions, the recreational activities
appropriate for each unit and for areas within each unit vary as well.
An action appropriate in one unit could impair resources in another
unit. Thus, this EA analyzes the context, duration, and intensity of
impacts related to an oral rabies vaccination program at the following
NPS units:

-   Allegheny Portage Railroad National Historic Site, PA

-   Delaware Water Gap National Recreation Area, PA & NJ

-   Fort Necessity National Battlefield, PA

-   Friendship Hill National Historic Site, PA

-   Johnstown Flood National Memorial, PA

-   Bluestone National Scenic River, WV

-   Gauley River National Recreation Area, WV

-   New River Gorge National River, WV

as well as potential for resource impairment, as required by NPS
*Director's Order #12: Conservation Planning, Environmental Impact
Analysis and Decision-making (DO-12).*

**Pubic Law 88-546. Allegheny Portage Railroad National Historic Site
and Johnstown Flood National Memorial** were both established by Public
Law on August 31, 1964 to preserve this remarkable feat of civil
engineering and to commemorate the tragic Johnstown Flood of May 31,
1889, respectively.

**Public Law 89-158. Delaware Water Gap National Recreation Area** was
established by Public Law on September 1, 1965 as a National Recreation
Area to preserve a portion of the middle Delaware River and land along
the river\'s New Jersey and Pennsylvania shores. This NPS unit was also
declared a National Scenic River on November 10, 1978 and Minisink
Archeological Site on April 19, 1993.

**Act of March 4, 1931. Fort Necessity National Battlefield** was
established by an Act of Congress on March 4, 1931 to commemorate the
Battle of Fort Necessity on July 3, 1757.

**Public Law 95-625. Friendship Hill National Historic Site** was
authorized by the National Parks and Recreation Act in November, 1978
for the purpose of commemorating the life of Albert Gallatin, a
prominent Jeffersonian-era statesman, public servant, and entrepreneur.

**Act of October 26, 1988. Bluestone National Scenic River** was
established by an Act of Congress on October 26, 1988 as a National
Scenic River to protect, preserve, and interpret the natural, cultural
and scenic resources of the area; protect the existing free-flowing
condition of these river segments; increase public awareness and
understanding of resource stewardship through educational programs and
interpretive services; promote public understanding of park ownership by
all citizens and future generations; and provide resource-based visitor
experiences which do not impair resource values.

**Act of October 26, 1988. Gauley River National Recreation Area** was
established by an Act of Congress on October 26, 1988 as a National
Recreation Area to protect, preserve, and interpret the natural,
cultural and scenic resources of the area; protect the existing
free-flowing condition of these river segments; increase public
awareness and understanding of resource stewardship through educational
programs and interpretive services; promote public understanding of park
ownership by all citizens and future generations; and provide
resource-based visitor experiences which do not impair resource values.

**Act of November 10, 1978. New River Gorge National River** was
established by an Act of Congress on November 10, 1978 as a National
River to protect, preserve, and interpret the natural, cultural and
scenic resources of the area; protect the existing free-flowing
condition of these river segments; increase public awareness and
understanding of resource stewardship through educational programs and
interpretive services; promote public understanding of park ownership by
all citizens and future generations; and provide resource-based visitor
experiences which do not impair resource values. The New River was also
designated an American Heritage river on July 30, 1998.

**Act of March 2, 1931 (7 U.S.C. 426, 426b and 426c).** APHIS-WS is
authorized to conduct programs to address wildlife-caused disease
problems, including the suppression of rabies in wildlife, by the Act of
March 2, 1931, as amended.

**7 U.S.C. Sec. 147b.** This law authorizes the Secretary of
Agriculture, in connection with emergencies which threaten any segment
of the agricultural production industry of the U.S., to transfer from
other appropriations or funds available to the agencies or corporations
of USDA such sums as the Secretary may deem necessary, to be available
only in such emergencies for the arrest and eradication of contagious or
infectious diseases of animals. It is under this authority that funds
from the federal Commodity Credit Corporation have been transferred to
APHIS-WS to expend for the continuation and expansion of ORVAC programs
in the eastern U.S. (65 FR 76606-76607, December 7, 2000).

**Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.)**. The oral rabies
vaccine (RABORAL V-RG®) is licensed for treatment of raccoons and
coyotes by the USDA under the Virus-Serum-Toxin Act (VSTA). Animal
vaccines shipped in or from the U.S. must be prepared under a USDA
license. Animal vaccines may not be imported without a USDA license.
Federal regulations implementing the VSTA (9 CFR 103.3) require
authorization by APHIS before an experimental biological product can be
shipped for the purpose of treating limited numbers of animals as part
of an evaluation process. The license for RABORAL V-RG® requires that it
be restricted for use in State or Federal rabies control programs.

**Public Health Service Act**. The CDC located in Atlanta, Georgia, is
an agency of the U.S. Department of Health & Human Services. CDC\'s
Mission is to promote health and quality of life by preventing and
controlling disease, injury, and disability. CDC is authorized under 42
U.S.C. 241 to render assistance to other appropriate public authorities
in the conduct of research, investigations, demonstrations, and studies
relating to the causes, diagnosis, treatment, control, and prevention of
physical and mental diseases and impairments of man. In addition, under
42 U.S.C. 243(a), the Secretary of Health & Human Services, may assist
states and their political subdivisions in the prevention and
suppression of communicable diseases.

**[State Authorities]{.underline}**

Each of the states involved in this proposed action has a state agency
or agencies with authority under state law to approve, conduct or
coordinate rabies control programs. NPS involvement in rabies control in
each state would only occur in complete cooperation with the appropriate
state agency(ies) and in accordance with state authorities as identified
by those agencies.

**Pennsylvania Game Commission (Law 322 (a) Title 34).** The PA Game
Commission is charged to protect, propagate, manage, and preserve the
game or wildlife of this Commonwealth and to enforce, by proper actions
and proceedings, the law of this Commonwealth relating thereto.

**Pennsylvania Department of Agriculture (PA Agriculture Code: Chapter
23; Section 2327 (d)).** The PA Department of Agriculture is authorized
to solicit assistance from and provide assistance to federal and other
state agencies, local governments and private entities in monitoring
wild animals in this Commonwealth to determine the presence of dangerous
transmissible diseases.

[]{.mark}

**Pennsylvania Department of Health (PA Administrative Code: Chapter
532; Section 2102 (a)).** The PA Department of Health is authorized to
protect the health of the people of this Commonwealth and to determine
and employ the most efficient and practical means for the prevention and
suppression of disease.

**New Jersey Department of Environmental Protection, Division of Fish
and Wildlife (NJDFW).** The mission of the NJDFW is to protect and
manage NJ's fish and wildlife to maximize their long-term biological,
recreational, and economic values for NJ's residents.

**New Jersey Department of Agriculture (NJDA).** The mission of the NJDA
is to develop, promote, conserve, and support the agriculture and
agribusiness industry of the state and those natural and renewable
resources that are associated with agriculture and other open lands for
the benefit of all its citizens.

**New Jersey Department of Health and Senior Services (NJDHSS).** The
NJDHSS provides guidance on public health related issues and potential
health problems associated with wildlife.

[]{.mark}

**West Virginia Department of Agriculture (WV Code of State Regulations
Section §19-9-2A).** The WV Department of Agriculture is charged with
prevention, suppression, control, and eradication of any communicable
disease of animals or poultry.

**West Virginia Department of Health and Human Resources (WV Code of
State Regulations Chapter 16, Section §16-2-11 (a)(1)(iii)).** Chapter
16 of the WV Department of Health and Human Resources authorizes the
creation of a state public health system, including local boards of
health, whose duties include "prevention and control of rabies."

**West Virginia Division of Natural Resources (WV Code of State
Regulations Section §20-2-1).** The WV Division of Natural Resources is
charged with protecting the wildlife resources for the use and enjoyment
of all the citizens in WV.

**1.5 OTHER RELEVANT FEDERAL LAWS AND REGULATIONS**

**National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.).**
NPS prepares analyses of the environmental impacts of program activities
to meet procedural requirements of this law. This EA is intended to meet
the NEPA requirement for the proposed action by clearly communicating
the scope of federal involvement and by determining if there are any
substantive new issues or alternatives that should be analyzed.

**Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.)**. It is federal
policy, under the ESA, that all federal agencies shall seek to conserve
threatened and endangered (T&E) species and shall utilize their
authorities in furtherance of the purposes of the Act (Sec.2(c)). For
actions that "may affect" listed species, NPS conducts Section 7
consultations with the U.S. Fish & Wildlife Service (USFWS) to ensure
that \"*any action authorized, funded or carried out by such an agency .
. . is not likely to jeopardize the continued existence of any
endangered or threatened species . . . Each agency shall use the best
scientific and commercial data available*\" (Sec.7(a)(2)).

**National Historical Preservation Act (NHPA) of 1966 as amended (16
U.S.C. 470)**. The NHPA and its Implementing Regulations (36 CFR 800)
require federal agencies to: 1) determine whether activities they
propose constitute "undertakings" that can result in changes in the
character or use of historic properties and, 2) if so, to evaluate the
effects of such undertakings on such historic resources and consult with
the State Historic Preservation Office regarding the value and
management of specific cultural, archaeological and historic resources,
and 3) consult with appropriate American Indian tribes to determine
whether they have concerns for traditional cultural properties in areas
of these federal undertakings.

ORVAC activities described under the proposed action do not cause major
ground disturbance, do not cause any physical destruction or damage to
property, do not cause any alterations of property, wildlife habitat, or
landscapes, and do not involve the sale, lease, or transfer of ownership
of any property. In general, such methods also do not have the potential
to introduce visual, atmospheric, or audible elements to areas in which
they are used that could result in effects on the character or use of
historic properties. Therefore, the methods that would be used under the
proposed action are not generally the types of activities that would
have the potential to affect historic properties. If an individual
activity with the potential to affect historic resources is planned
under an alternative selected as a result of a decision on this EA, then
site-specific consultation as required by Section 106 of the NHPA would
be conducted as necessary.

**Wilderness Act of 1964 -- An Act (Public Law 88-577; 88^th^ Congress,
S.4; September 3, 1964).** The Wilderness Act allows federally owned
lands meeting specific criteria to be designated as "wilderness areas."
The act prohibits and restricts certain uses of these designated lands.
The act provides special provisions to allow certain activities to take
place within designated wilderness areas such as the use of aircraft to
control fire, insects and diseases (Sec. 4 (d)).

**Clean Air Act of 1970 as amended (42 U.S.C. 7401).** The Clean Air Act
is a comprehensive federal law that regulates air emissions from area,
stationary, and mobile sources.

**1.6 RELATIONSHIP TO OTHER ENVIRONMENTAL DOCUMENTS**

**NPS PLANS**

**NPS Management Policies 2001 (USDI 2000b).** This manual provides
guidance on enhancing visitor safety (Section 8.2.5.1), which directly
relates to this proposed project. The expanding epidemic of raccoon
rabies in the eastern U.S. is considered a public health emergency
(Clark and Wilson 1995) and is therefore considered under the visitor
safety section of the manual. The proposed project is, therefore,
consistent with the NPS *Management Policies 2001* manual. Additionally,
NPS personnel reviewed the appropriate plans (i.e., strategic, general
management, and resource management plans) for individual park units.
There are no conflicts between the proposed action and any existing park
plans. The proposed action is consistent with national guidance.

-   **Allegheny Portage Railroad National Historic Site and Johnstown
    Flood National Memorial**

    -   **General Management Plan (1980).** This plan was prepared to
        provide a definitive guide for management to follow in
        implementing the authorizing legislation. It specified
        management actions required to meet the objectives and realize
        the park's purposes.

    -   **Resources Management Plan (1998).** This plan is an action
        statement for implementing the broad management objectives
        specified in the General Management Plan and Statements for
        Management. It provides a basic framework for the continuous
        protection, management, and maintenance of the cultural and
        natural resources found at these parks in accordance with the
        NPS standards and legislative mandates.

    -   **Strategic Plan for Allegheny Portage Railroad National
        Historic Site 2000-2005 (2000).** This plan contains goals for
        Fiscal Years 2000-2005 and strategies on how goals will be
        accomplished.

    -   **Strategic Plan for Johnstown Flood National Memorial 2000-2005
        (2000).** This plan contains goals for Fiscal Years 2000-2005
        and strategies on how goals will be accomplished.

    -   **Statement for Management Allegheny Portage Railroad National
        Historic Site (1992).** This statement provides an overview of
        the purpose and significance of the park, inventory of existing
        conditions, problems, and opportunities, and identifies
        objectives for the future of the area.

    -   **Statement for Management Johnstown Flood National Memorial
        (1992).** This statement provides an overview of the purpose and
        significance of the park, inventory of existing conditions,
        problems, and opportunities, and identifies objectives for the
        future of the area.

[]{.mark}

-   **Delaware Water Gap National Recreation Area**

    -   **General Management Plan (1986).** This plan outlines
        strategies for meeting legislative requirements. It also seeks
        to achieve the management objectives that have been developed
        for the national recreation area, and it addresses issues and
        management concerns relating to daily operations.

-   **Fort Necessity National Battlefield**

    -   **General Management Plan (1991).** This plan presents the NPS'
        preferred approach to accomplishing the park's management
        objectives and resolving a wide range of issues affecting the
        park. Most of the issues focus on protecting critical historic
        resources, substantially upgrading the interpretive program,
        improving visitor accessibility and safety, and making
        operations more efficient.

    -   **Resources Management Plan (1994).** This purpose of this plan
        is to provide a comprehensive, yet brief, description of the
        park's resources, associated problems, recommended actions to
        solve or study the problems and the impacts upon the park's
        environment of any proposed or implemented activity or project,
        and provide for the transfer of information from the park's
        resource management program to the park staff and public.

-   **Friendship Hill National Historic Site**

    -   **General Management Plan (1982).** This plan is both a
        manager's guide for meeting the objectives established for this
        park unit and a public statement of NPS management intentions.
        The plan establishes long-range strategies for resource
        management, visitor use, and development of an integrated park
        system, creating a framework for all future programs,
        facilities, and management actions.

    -   **Resources Management Plan (1994).** This purpose of this plan
        is to provide a comprehensive, yet brief, description of the
        park's resources, associated problems, recommended actions to
        solve or study the problems and the impacts upon the park's
        environment of any proposed or implemented activity or project,
        and provide for the transfer of information from the park's
        resource management program to the park staff and public.

-   **Bluestone National Scenic River**

    -   **General Management Plan (1982, being updated 2004).** This
        plan will yield a realistic framework for making future
        management and development decisions for the Bluestone National
        Scenic River.

-   **Gauley River National Recreation Area**

    -   **General Management Plan (1996).** This plan establishes the
        resource conditions and visitor experiences that are to be
        achieved and maintained over time in each area of the Gauley
        River National Recreation Area.

    -   **Gauley River Development Concept Plan and Environmental
        Assessment (being prepared 2004).** This plan will document how
        the NPS will manage resources and provide visitor experiences at
        the Gauley River National Recreation Area.

-   **New River Gorge National River**

    -   **General Management Plan (1982, being updated 2004).** This
        plan will guide the management of the park for the next 15 to 20
        years. It defines a vision for the future and provides a
        practical framework for decision-making on park issues,
        including how to protect park resources and provide for quality
        visitor experiences.

[]{.mark}

**NEPA DOCUMENTS**

A number of other NEPA documents have been prepared that analyzed the
potential environmental effects of ORVAC programs. Pertinent information
from those analyses has been incorporated by reference into this EA.

**APHIS-WS Programmatic EIS.** APHIS-WS has issued a final Environmental
Impact Statement (EIS) (USDA 1997) and Record of Decision on the
National APHIS-WS program.

**EA and Finding of No Significant Impact -- Oral Rabies Vaccination
Program.** This EA (USDI 2004a) and Decision/Finding of No Significant
Impact (FONSI), dated June 28, 2004, analyzed the environmental effects
of NPS participation in ORVAC programs on fifteen NPS units in the
states of Alabama, Florida, Georgia, North Carolina, and Tennessee in
the effort of stopping the spread of a specific raccoon rabies variant
or "strain" of the rabies virus and reducing or eliminating this strain
of the virus from the eastern United States. The NPS determined the
action would have a negligible impact on the quality of the human
environment.

**EA and Finding of No Significant Impact -- Oral Rabies Vaccination
Program for Big Bend National Park, Guadalupe Mountains National Park,
and Amistad National Recreation Area in Texas.** This EA (USDI 2003) and
Decision/Finding of No Significant Impact (FONSI), dated June 13, 2003,
analyzed the environmental effects of NPS participation in ORVAC
programs to eliminate or stop the spread of gray fox rabies on three NPS
units in Texas. The NPS determined the action would have a negligible
impact on the quality of the human environment.

**EA and Finding of No Significant Impact -- Oral Vaccination to Control
Specific Rabies Virus Variants in Raccoons, Gray Foxes, and Coyotes in
the United States.** This EA (USDA 2001a) and Decision/FONSI (2001b),
dated July 30, 2001; a supplemental Decision/FONSI, dated August 5, 2002
(USDA 2002); a supplemental EA (USDA 2003a) and Decision/FONSI (USDA
2003b), dated June 12, 2003; and the most recent supplemental EA (USDA
2004d) and Decision/FONSI, dated September 9, 2004 (USDA 2004e) analyzed
the environmental effects of APHIS-WS involvement in the funding of and
participation in ORVAC programs to eliminate or stop the spread of
raccoon rabies in 25 eastern states (Alabama, Connecticut, Delaware,
Florida, Georgia, Indiana, Kentucky, Louisiana, Maine, Maryland,
Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New
York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina,
Tennessee, Vermont, Virginia, and West Virginia) plus the District of
Columbia and gray fox and coyote rabies in Texas. APHIS-WS determined
the action would have a negligible adverse impact on the quality of the
human environment.

**EA and Finding of No Significant Impact - Oral vaccination to Control
specific rabies virus variant in raccoons on National Forest System
lands in the United States.** This EA (USDA 2004c) and FONSI, dated
February 12, 2004, analyzed the potential environmental effects of a
proposal to expand the involvement of the APHIS-WS program in ORVAC
programs to portions of National Forest System lands, excluding
Wilderness Areas, in a number of eastern states. The National Forest
System lands where APHIS-WS involvement would be expanded may be located
within the states of Alabama, Georgia, Florida, Kentucky, Maine,
Maryland, Massachusetts, New Hampshire, New Jersey, New York, North
Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Vermont,
Virginia, and West Virginia. Numerous National Forest System lands are
located within current and potential ORVAC barrier zones. To effectively
combat this strain of the rabies virus, it has become increasingly
important to bait these large land masses.

**EA and Finding of No Significant Impact -- Proposed Issuance of a
Conditional United States Veterinary Biological Product License to Rhone
Merieux, Inc., for Rabies Vaccine, Live Vaccinia Vector.** This EA and
its FONSI dated April 7, 1995 was prepared by APHIS and concluded there
would be no significant impact on the quality of the human environment
from the decision to issue the conditional license referred to above
(USDA 1995a). The conditional license approved the use of V-RG in
raccoon rabies control programs administered under the direction of
state or federal government agencies. This vaccine was studied under
both laboratory and field trials prior to distribution and use in 1995
to control the spread of various strains of the rabies virus. No
ecological concerns were determined to be associated with the licensing
of the rabies vaccine (USDA 1991, 1992, 1993, 1994a, 1994b, 1994c,
1995a, *undated a, undated b*). USDA determined that the parental
vaccinia virus has not established itself in nature, is readily consumed
by target animal species, and does not cause bioaccumulation in the
environment. Mitigative measures required under the decision included
public education and notification efforts prior to distributing the
baits, and the placement of warning labels on each vaccine-laden bait.

**EA and Finding of No Significant Impact -- Proposed Field Application
of an Experimental Rabies Vaccine, Live Vaccinia Vector, in South
Texas**. This EA and its FONSI completed in 1995 analyzed the
environmental effects of experimental distribution of ORVAC baits
containing V-RG to eliminate and stop the spread of coyote rabies in
south Texas (USDA 1995b). APHIS determined the action would have a
negligible adverse impact on the quality of the human environment.

**EAs and Findings of No Significant Impact on proposed field
trials/tests of live experimental vaccinia-vector recombinant rabies
vaccine for raccoons**. APHIS analyzed the potential environmental
impacts of six separate field trials or tests of the recombinant V-RG
vaccine in several northeastern states. In EAs and FONSIs covering those
actions, (USDA 1991, 1992, 1993, 1994a, 1994b, 1994c), APHIS determined
that these actions would have a negligible adverse impact on the quality
of the human environment.

**Risk Analyses for ORVAC using the V-RG recombinant virus.** Two formal
risk analyses on the rabies vaccine \-- live vaccinia vector (i.e., the
recombinant V-RG vaccine) have been prepared previously by APHIS (USDA
*undated a and undated* *b*). Both analyses concluded the risk of
adverse effects to animal safety, human safety, or the environment to be
negligible.

**1.7 DECISION TO BE MADE**

Based on the scope of this EA, the decisions to be made are:

-   Should the NPS approve ORVAC bait distribution at several NPS units
    within the Northeast Region's Eastern Rivers and Mountains Network
    Park grouping (see Section 1.2 for a list of park units)?

-   Would the proposed action have significant impacts on the quality of
    the human environment requiring preparation of an EIS?

**1.8 GOALS**

The primary goals of the proposed raccoon ORVAC program are:

-   to cooperate with involved state agencies and APHIS-WS in
    eliminating or stopping the northward and westward advance of the
    raccoon strain of rabies in the eastern U.S. by approving the use of
    ORVAC on NPS lands to immunize portions of target species
    populations along the leading edges of the rabies fronts; and

-   to cooperate with involved state agencies and APHIS-WS in reducing
    the incidence of rabies cases involving wild and domestic animals
    and rabies exposures to humans in the areas where the ORVAC programs
    are conducted.

*[Monitoring]{.underline}*

APHIS-WS and involved state agencies will be responsible for determining
the overall success of the ORVAC program and will use data collected
from areas outside of NPS lands to monitor vaccination rates and
instances of raccoon rabies virus.

**[1.9 SCOPE OF THIS ENVIRONMENTAL ASSESSMENT ANALYSIS]{.smallcaps}**

**Actions Analyzed/Site Specificity.** This EA analyzes the potential
environmental effects of NPS participation in an ORVAC program at
numerous parks in the states of PA, NJ, and WV located within the NPS
Northeast Region's Eastern Rivers and Mountains Network Parks grouping
(see Section 1.2 for a list of NPS units). The program would support the
involved state agencies' efforts of eliminating or stopping the
northward and westward spread of raccoon rabies in the eastern U.S.

**Period for which this EA is Valid.** This EA will remain valid until
the NPS determines that new needs for action, new unforeseen significant
issues, or new alternatives having different environmental effects must
be analyzed. At that time, this analysis and document will be revised
pursuant to NEPA.

**1.10 SCOPING PROCESS**

Scoping is an early and open process to determine the breadth of
environmental issues and alternatives to be addressed in an EA. The NPS
Northeast Region conducted internal scoping with appropriate staff from
the NPS and APHIS-WS. The interdisciplinary internal scoping process
defined the purpose and need, identified potential actions to address
the need, determined what the likely issues and impact topics would be,
and identified the relationship, if any, of the proposed action to other
planning efforts at NPS units located within the three potentially
affected states (PA, NJ, and WV).

The external scoping process was conducted with the public and
interested and affected groups and agencies. A scoping notice was issued
on January 29, 2004 and was directly mailed to 254 interested and
affected groups and agencies, including potentially affected American
Indian tribes. Comments were solicited during external scoping until
March 5, 2004. Two comment letters were received during the 36 day
scoping period. Comments were received from: 1) Donald Lein, DVM, PhD,
Cornell University, College of Veterinary Medicine, NY State Animal
Health Diagnostic Laboratory; and 2) Eric Hardy, President -- Allegheny
Coonhunters Association, Vice-President -- WV Sporting Dog Association,
Secretary -- WV Coonhunters Association, Member -- WV Bearhunters
Association. Both commenters were in support of the program. The second
commenter asked that baits be made available to coonhunters and farmers
as they know where to find the highest densities of raccoons.

No other alternatives were proposed.

**2.0 CHAPTER 2: ISSUES AND AFFECTED ENVIRONMENT**

**2.1 ISSUES**

From comments received during scoping periods for other ORVAC EAs and
interactions and input received from those involved with the national
ORVAC program, the following issues were determined to be germane to the
proposed action and were considered in detail in Chapter 4:

-   Potential for adverse effects on people that become exposed to the
    vaccine or the baits.

-   Effects of the ORVAC V-RG vaccine on raccoons.

-   Potential for adverse effects on nontarget wildlife species,
    including threatened or endangered species.

-   Potential for adverse effects on pet dogs or other domestic animals
    that might consume the baits.

-   Potential for the recombined V-RG virus to "revert to virulence" and
    result in a virus that could cause disease in humans or animals.

-   Potential for the V-RG virus to recombine with other viruses in the
    wild to form new viruses that could cause disease in humans or
    animal

-   Potential for aerially dropped baits to strike and injure people or
    domestic animals.

-   Potential impacts on visitor use/experience

    **2.2 ISSUES DISMISSED FROM FURTHER ANALYSIS**

    **2.2.1 Potential for Adverse Impacts on Wildlife from Aircraft
    Overflights**

    The concern here is that wildlife species on NPS lands might be
    disturbed by the aircraft used in ORVAC bait distribution to the
    point that they are adversely affected.

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-   USDI (1995) reviewed studies on the effects of aircraft overflights
    on wildlife. The report revealed that a number of studies have
    documented responses by certain wildlife species that suggest
    adverse impacts could occur. Few if any studies have proven that
    aircraft overflights adversely impact populations, although the
    report stated it is possible to draw the conclusion that impacts to
    wildlife populations are occurring. It appears that some species
    will frequently or at least occasionally show adverse responses to
    even minor/short-term overflight occurrences. In general, it appears
    that the more serious potential impacts occur when overflights are
    *chronic*, i.e., they occur daily or more often over long periods of
    time. Chronic exposure situations generally involve areas near
    commercial airports and military flight training facilities. ORVAC
    program aerial bait distribution activities are not chronic, but
    occur only once per year. They are typically conducted at about 500
    feet above ground level and only fly momentarily over any one point
    on the ground during any given bait distribution flight. The
    aircraft do not circle over areas repeatedly, but fly in straight
    "transect" lines for purposes of bait distribution. Bait drops are
    normally conducted one time during the spring or fall months
    (February 1-May 31 and August 15-November 30).

    The following are some examples of species or species groups that
    have been studied with regard to this issue along with a
    determination of potential impacts from ORVAC aerial overflights:

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-   [Colonial Waterbirds]{.underline}. Kushlan (1979) reported that low
    level (390 feet followed by a second flight at 200 feet) overflights
    of 2-3 minutes in duration by a fixed-wing airplane and a helicopter
    produced no "drastic" disturbance of tree-nesting colonial
    waterbirds, and, in 90 percent of the observations, the individual
    birds either showed no reaction or merely looked up. ORVAC program
    overflights typically occur at about 500 feet above ground and would
    only fly momentarily over any one point on the ground. Thus, it
    appears that ORVAC program overflights would result in little or no
    disturbance to colonial waterbirds.

-   [Greater Snow Geese]{.underline}. Belanger and Bedard (1989, 1990)
    observed responses of greater snow geese (*Chen caerulescens
    atlantica*) to man-induced disturbance on a sanctuary area and
    estimated the energetic cost of such disturbance. They observed that
    disturbance rates exceeding two per hour reduced goose use of the
    sanctuary by 50 percent the following day. They also observed that
    about 40 percent of the disturbances caused interruptions in feeding
    that would require an estimated 32 percent increase in nighttime
    feeding to compensate for the energy lost. They concluded that
    overflights of sanctuary areas should be strictly regulated to avoid
    adverse impacts. ORVAC program overflights typically occur at about
    500 feet above ground and would only fly momentarily over any one
    point on the ground. Thus, it appears that ORVAC program overflights
    would result in little or no disturbance to snow geese or other
    waterfowl species.

-   [Raptors]{.underline}. Andersen et al. (1989) conducted low-level
    helicopter overflights directly at 35 red-tailed hawk (*Buteo
    jamaicensis*) nests and concluded their observations supported the
    hypothesis that red-tailed hawks habituate to low level flights
    during the nesting period. Their results also showed similar nesting
    success between hawks subjected to such overflights and those that
    were not. White and Thurow (1985) did not evaluate the effects of
    aircraft overflights, but showed that ferruginous hawks (*Buteo
    regalis*) are sensitive to certain types of ground-based human
    disturbance to the point that reproductive success may be adversely
    affected. However, military jets that flew low over the study area
    during training exercises did not appear to bother the hawks, and
    neither were they alarmed when the researchers flew within 100 feet
    in a small fixed-wing aircraft (White and Thurow 1985). White and
    Sherrod (1973) suggested that disturbance of raptors by aerial
    surveys with helicopters may be less than that caused by approaching
    nests on foot. Ellis (1981) reported that 5 species of hawks, 2
    falcon species, and golden eagles were "incredibly tolerant" of
    overflights by military fighter jets, and observed that, although
    birds frequently exhibited alarm, negative responses were brief and
    never limiting to productivity. These studies indicate that
    overflights by ORVAC program aircraft should have no significant
    adverse impacts on raptor populations by affecting nesting success.

-   [Bald Eagles]{.underline}. Several studies have shown that bald
    eagles (*Haliaeetus leucocephalus*) elicited varied responses (e.g.,
    no response, alert, agitation, or flushing) by overflights of
    different types of aircraft such as military jets, fixed-wing
    aircraft, light planes, and helicopters (Grubb and Bowerman 1997,
    Watson 1993, Stalmaster and Kaiser 1997). Helicopters appeared to
    produce the greatest response, with military jets second, and fixed
    wing and light planes third (Grubb and Bowerman 1997, Watson 1993,
    Stalmaster and Kaiser 1997). The frequency of response and frequency
    of flight by bald eagles both increased through the nesting season
    from February to June (Grubb and Bowerman 1997). However, bald
    eagles were disturbed at higher rates when there were no young in
    the nest, when they were away from the nest, or when helicopters
    were hovering rather than moving (Watson 1993). The distance between
    eagle and aircraft, overflight duration, number of passes over nest,
    and type of aircraft appeared to be the most important
    characteristics influencing eagle responses (Grubb and Bowerman
    1997, Watson 1993, Stalmaster and Kaiser 1997). However, Grubb and
    King (1991) concluded breeding bald eagles in Arizona may have
    become habituated to aircraft. Habituation was also reported at a
    nest site near a military air base in Michigan (Grubb et al. 1992,
    Grubb and Bowerman 1997). Nesting bald eagles have also been
    surveyed from fixed-wing aircraft with minimal disturbance (Fraser
    et al. 1985, Watson 1993). In general, conclusions about adverse
    effects on bald eagles and other raptors from aircraft overflights
    appear to be speculative. However, no direct evidence of adult or
    young mortality during helicopter or fixed-wing overflights has been
    observed (Watson 1993, Fraser et al. 1985). Although habituation may
    occur, most findings supported the use of buffer zones to distance
    nesting bald eagles from aircraft activity. Watson (1993)
    recommended helicopters remain at a distance greater than 60 meters
    from nests. Stalmaster and Kaiser suggested a buffer of 400-800
    meters from military activity such as boats, aircraft and
    explosions. However, this suggestion is for wintering bald eagles.
    Grubb and Bowerman (1997) recommended any type of human activity be
    conducted at a distance of 400 meters or greater from nesting bald
    eagles. If this limitation is impractical, they recommended that
    duration and number of aircraft and/or passes be limited to less
    than 5 minutes and one aircraft and/or pass. This scenario would be
    expected for rabies bait distribution overflights, which would only
    involve one overflight pass, once per year, in which the duration of
    the pass over a given nest site would only be a few seconds at most.

    Occasional overflights (i.e., radio telemetry, GIS mapping,
    commercial flights, and military training routes by fighter jets,
    helicopters, and/or transport ships) may occur over park units.
    Overflights for the purposes of ORVAC bait distribution activities
    would only occur once per year and aircraft will only fly
    momentarily over any one point on the ground. The aircraft do not
    circle over areas repeatedly, but fly in straight "transect" lines
    for the purposes of bait distribution. The potential impact would be
    of short-term duration, on a local scale, with negligible intensity
    and should not add appreciably to the frequency of overflights. The
    addition of one more overflight per year for ORVAC bait distribution
    should not constitute a substantive increase in any effects that
    might occur as a result of overflights. Furthermore, the types of
    aircraft used in bait distribution, the DeHavilland (DHC-6) Twin
    Otter and Beechcraft King Air B200, meet all Federal Aviation
    Regulation (FAR) requirements regarding noise limits (FAR Part 36).
    Therefore, cumulative impacts from the combination of ORVAC bait
    distribution overflights and other overflights should be negligible.
    Thus, the short-term duration, infrequency, and negligible intensity
    of flights over any given area, in addition to the tolerance of
    wildlife of such activity, would have a negligible adverse
    environmental impact on wildlife as a result of ORVAC program
    overflights. []{.mark}

At the request of the NPS, APHIS-WS consulted with the USFWS on
migratory bird issues with regard to the ORVAC program on NPS units. The
USFWS -- Division of Migratory Birds in Hadley, MA (NE Regional Office)
determined there would be no adverse impacts to migratory birds from the
ORVAC program. However, the USFWS NJ Field Office supervisor stated in
informal consultation that aerial overflights may adversely affect the
federally listed (threatened) bald eagle on or adjacent to the Delaware
Water Gap National Recreation Area -- NJ/PA if activities are conducted
during the nesting season. The USFWS stated that even single passes of
low-flying aircraft can cause abandonment of eagle nests or injury to
flightless young. To ensure that nesting bald eagles are not adversely
affected by low-flying aircraft, the USFWS recommends that flights
maintain a minimum vertical distance of 1,500 feet above ground level in
the vicinity of the nest sites or at least 1 mile lateral distance from
the nest sites. If aerial distribution of baits occurs during the
nesting season, the USFWS requests bait disbursal activities be
coordinated with the USFWS NJ/PA Field Office and NPS units 30 days
prior to bait distribution to obtain a current list of eagle nest
locations that may be affected by use of low-flying aircraft. The USFWS
believes aerial distribution of baits outside the nesting season is
unlikely to adversely affect nesting eagles. No evidence has been found
to indicate harm to eagles or other raptors as the result of an annual
overflight. In addition, the annual overflight is even less likely to
adversely impact migratory birds if/when flights occur in the fall after
the birds have dispersed. Therefore, impacts from ORVAC bait
distribution overflights should be negligible.

**2.2.2 Potential Human Health Impacts Resulting from the Human
Consumption of a Vaccinated Wild Animal**

The issue expressed here is the potential to develop a vaccinia
infection from eating a vaccinated animal that has eaten one or more
ORVAC baits as hunting is permitted in several of the NPS units listed
under the proposed action, including the Delaware Water Gap in PA/NJ and
the Bluestone National Scenic River, Gauley River National Recreation
Area, and New River Gorge National River in WV. Dr. Carolin Schumacher
of Merial, Inc. was consulted to obtain information on this issue.
Mahnel (1987) reported results of experiments to determine the stability
of poxviruses (which include vaccinia used in the V-RG vaccine). "Naked"
vaccinia (i.e., vaccinia found outside of host cells) will be
inactivated within minutes by heat above 133 degrees Fahrenheit, by
ultra-violet irradiation (sunlight), or by exposure to acid with a pH of
3 or less[^3] (e.g., similar to the acid environment found in the
stomach of animals). In contrast, however, poxviruses can be relatively
stable for years in dry dust or in dried lesion crusts.

The vaccinia from V-RG would generally only bind to animal tissues in
the mucous membrane of the oral cavity, pharynx and oesophagus since
V-RG does not have the tendency to spread throughout the animal. Those
particular tissues are rarely consumed by humans, but if they were, they
would most likely be cooked which would kill the virus. Also,
concentrations of vaccinia in those tissues should be low because mucosa
is not considered a tissue where the virus tends to accumulate
(Schumacher, Merial, Inc., pers. comm. 2001 *in* USDA 2001a).

Although cell-bound vaccinia is generally more resistant than free
virus, humidity and cellular enzyme activity in the tissues as well as
bacterial decomposition (e.g., in the gut of ruminants), normally
results in inactivation of the virus. In the environment, inactivation
of pox viruses is accelerated by temperature changes (Schumacher,
Merial, Inc., pers. comm. 2001 *in* USDA 2001a).

The above information suggests that possible sources of contamination
with vaccinia would be V-RG dried onto the fur of an animal, ingested
virus in the stomach, or cell-bound virus in mucous membranes. However,
with the combined activity of sunlight and ultraviolet light, humidity,
stomach pH and/or bacteria/enzymes, temperature fluctuations, and
cooking heat, the risk to human health should be negligible, especially
when taking into consideration the attenuated or weakened condition of
the vaccinia in the V-RG vaccine. Therefore, the potential for adverse
health effects from consuming animals that have eaten ORVAC baits should
be low. []{.mark}

**2.2.3 Potential for ORVAC Bait Distribution to Affect Organic
Farming**

This issue concerns the potential for ORVAC baits dropped on crops and
livestock operations certified as \"organic\" under federal regulations
to affect the status of the organic certification of such farms. Farmers
and livestock producers were concerned they would not be able to sell,
label, or represent their harvested crop or plant as organically
produced if it had contact with the prohibited substance, which is the
vaccine -- V-RG (CFR7 Part 205.672). In particular, this concern was
raised by a producer of organically raised venison in Ohio (R. Krogwold,
Ohio Dept. of Health, pers. comm. 2001) and by an organic farmer in
Florida (H. McConnell, APHIS-WS, pers. comm. 2003).

The ORVAC baits are comprised of a matrix of fishmeal and an ethylene
copolymer which is a plastic material. The purpose of the polymer is to
hold the fishmeal attractant together in a block that can withstand
being dropped from an airplane and that will not dissolve or crumble
apart readily when and if it is exposed to rain or melting snow. The
process for producing the bait blocks eliminates all potentially
reactive compounds (such as ethylene and vinyl acetate) that might have
the potential for uptake by plants or absorption into the tissues of
animals that consume the baits. Thus, the inorganic polymer in the ORVAC
baits is totally nonreactive and cannot be absorbed by plants or animals
(M. Smith, Bait-Tek, pers. comm. 2001). It is also among the types of
materials approved by the Food and Drug Administration for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food (21 CFR Part 177). Therefore,
the fishmeal polymer baits should pose no risk of contaminating crops or
animals raised for food and, consequently, should have no effect on the
ability of certified organic farms to maintain their status.

Field baiting studies suggest deer are not generally attracted to the
ORVAC baits. Out of more than 4,300 baits exposed to target and
nontarget animals in field bait acceptance studies in Georgia, Ohio, and
Texas, none were observed to have been taken or consumed by deer,
despite the prevalence of deer in the areas where the bait studies were
conducted (Linhart et al. *unpublished* 2001). Sulfur compounds are a
byproduct of the breakdown of animal proteins, including those found in
fishmeal (D. Nolte, APHIS-WS, National Wildlife Research Center (NWRC),
pers. comm. 2001) and are generally repellent to herbivores (Nolte et
al. 1994). Therefore, the ORVAC baits used to address raccoon rabies
problems are probably at least somewhat repellent to deer, which
probably accounts in part for the lack of observed bait take by deer in
the studies reported in Linhart et al. (*unpublished* 2001). For these
reasons, it is unlikely that the ORVAC baits would be consumed by deer
on venison farms that are certified as organic producers.

On April 15, 2003, the USDA-Agricultural Marketing Service (AMS) ruled
that ORVAC bait blocks, consisting of a vaccine imbedded in fishmeal
bound by a polymer binding agent, on an organic operation would not have
an adverse impact on organic operations. This ruling was posted on the
USDA-AMS website at [www.ams.usda.gov/nop](http://www.ams.usda.gov/nop).
The USDA-AMS considers the ORVAC program to be an emergency disease
treatment for the control of rabies and, as such, is addressed under
National Organic Program (NOP) section 205.672, Emergency Pest or
Disease Treatment. The USDA-AMS determined that "...in the unlikely
event that a bait block breaks and exposes a plant(s) to the vaccine,
the organic producer can remove the affected plant(s) with no adverse
effect on the operation's certification. This would comply with NOP
section 205.672(a). The organic status of animals feeding on the ORVAC
bait block and not penetrating the vaccine would not be adversely
affected. In the unlikely event that an animal consumes the vaccine
within the ORVAC bait block that animal will lose organic status as
provided in NOP section 205.672(b)." The USDA-AMS believes there to be
little chance that an organic animal will consume the vaccine within an
ORVAC bait block; however, to reduce the chances of livestock
consumption, producers can relocate any bait found within an area
containing livestock to a point outside of that area.

**2.2.4 Potential Impacts on Water Resources**

A concern has been expressed regarding the potential impacts of
unconsumed V-RG vaccine and baits adversely impacting ground and surface
water resources through direct and indirect exposure. Those baits that
are not consumed may remain in the environment for several months after
placement dependent upon environmental conditions (precipitation,
temperature, etc.) and the physical condition of the baits. Potential
impacts to water resources are greatly reduced by the limited number of
baits that are dropped in a specific area, the biodegradability of the
vaccine liquid and baits, the high consumption rate of ORVAC baits by
animal species, the safety and efficacy of the vaccine, and the Standard
Operating Procedures (SOPs) that are used when dropping baits near a
large water source. This conclusion is based upon:

-   The possibility of a large quantity of ORVAC baits being exposed to
    a site specific water resource is extremely low due to the bait
    distribution densities used by the program. Under the proposed
    program ORVAC baits would be distributed from aircraft at an average
    density of 75 per square km.

-   The baits are non-toxic. The baits used for the raccoon ORVAC
    program are small blocks of fishmeal that are held together with a
    polymer binding agent and are considered to be "food grade"
    materials. Therefore the unconsumed bait material would biodegrade
    when exposed to the environment causing little to no effect on water
    resources.

-   The vaccinia virus and other orthopoxviruses will not replicate in
    water and do not replicate or reproduce themselves in
    non-warmblooded species (C. Rupprecht, CDC, pers. comm. 2002).
    Therefore, ORVAC is not expected to cause any adverse effects on
    fish, reptiles, amphibians, or any invertebrate species should any
    members of these species groups consume ORVAC baits or otherwise be
    exposed to the vaccine.

-   The ORVAC baits are readily taken up and consumed by wildlife
    species thereby limiting long term exposure to the environment. The
    likelihood of a bait being consumed is dependent upon several
    factors including animal population densities (target and nontarget
    species), bait preference, and the availability of alternative food
    sources. In field tests conducted in the U.S., the majority of ORVAC
    baits have been consumed within the first 7 to 14 days after
    placement, with reports of up to 100 percent of the baits being
    consumed within a 7 day period (Farry et al. 1998a and 1998b, Hable
    et al. 1992, Hadidian et al. 1989, Hanlon et al. 1989a, Linhart et
    al. 1994, Steelman et al. 2000, USDA 1995a).

-   The V-RG virus biodegrades when exposed to the environment. The V-RG
    virus that is not consumed by the target species or other
    vertebrates will become inactivated over a relatively short period
    of time. Persistence and stability of the V-RG virus outside of an
    organism is highly dependent on ambient temperature and local
    environmental conditions; the higher the temperature the quicker the
    virus will become inactive (USDA 1992, USDA 1995a). For example at
    temperatures between 68 and 100 degrees Fahrenheit the liquid
    vaccine potency remains stable for approximately 14 to 7 days,
    respectively, in the un-punctured sachet or inside the bait. In
    situations where the bait and sachet are damaged inactivation of the
    V-RG virus will occur more rapidly. A more detailed discussion of
    the development of ORVAC baits can be found in Chapter 1.

-   Program SOPs limit the possibility of ORVAC baits being directly
    dropped into large water sources such as rivers, lakes, and
    reservoirs. When the aircraft approaches a large body of water the
    bait dropping equipment is shut off approximately ¼ mile from the
    water source to reduce the possibility of ORVAC baits falling into
    the water. Nevertheless, due to changing environmental conditions
    and the limited possibility of human error when operating the bait
    dropping equipment there is the possibility that baits may
    inadvertently be dropped into a body of water. Exposure of the V-RG
    vaccine into a water source from an intact bait and sachet is highly
    unlikely. The vaccine is enclosed in a sealed sachet thereby
    limiting the possibility of the vaccine liquid being directly
    released into a water source. Even if the vaccine was released into
    a water source through a damaged or punctured sachet, it is highly
    unlikely that the vaccine will cause any adverse affects since the
    vaccine liquid is biodegradable and nontoxic (USDA 1991, USDA
    *undated a and undated b*).

    The above information indicates that V-RG vaccine and baits pose no
    threat to groundwater or surface water through direct or indirect
    means.

**2.2.5 The Affected Area Described in the EA includes NPS Lands that
Have Not Been Identified as Having a Rabid Raccoon Problem**

The affected area of the EA includes NPS lands that have or have the
potential for a raccoon rabies outbreak to occur. ORVAC baits are
distributed based upon vaccination zones. These vaccination zones are
determined in cooperation with the involved state rabies task forces,
state agencies, and/or other agencies with jurisdiction over vaccine use
and application in wildlife and domestic animal species. Vaccination
zones are delineated based on the most current distribution of rabies
cases and the expected direction of disease spread. Therefore some, all,
or none of the NPS lands identified in this EA may be involved in an
ORVAC bait distribution program on an annual basis. Figure 1-4 in
Chapter 1 shows the current anticipated ORVAC zone based upon recent
outbreaks of the virus. The numerous NPS units included in this EA (see
Section 1.2 for a list of park units) were chosen since they have the
greatest possibility of being involved in the states' (PA, NJ, and WV)
overall efforts of stopping the northward and westward spread of the
rabies virus in the eastern U.S.

**2.2.6 Effects on Carnivore Populations in the Absence of Rabies**

Concern has been expressed that specific carnivore populations, namely
raccoons, may increase in the absence of the rabies virus as a mortality
factor, leading to adverse effects on prey populations such as
threatened and endangered species. The raccoon strain of the rabies
virus has only relatively recently spread, and currently is contiguously
distributed from Alabama to Maine, west to the eastern Ohio border with
Pennsylvania (Krebs et al. 2001, Kemere et al. 2001). Translocation of
rabid raccoons to the mid-Atlantic states has been implicated in
establishing a new rabies foci in the mid-1970's (Krebs et al. 1999),
from which rabies has spread through the raccoon population at rates
averaging about 30 miles/year (Kemere et al. 2001).

As a disease existing within natural systems, raccoon rabies is only one
of several diseases which can influence dynamics of its vector and
reservoir populations, and there is no indication that it has more
serious effects on population levels than several other conditions.
Milius (1998) noted that vaccinating raccoons in the city of
Scarborough, Ontario against canine distemper in the early 1990s
successfully reduced the prevalence of the disease in raccoons. The
vaccination program did not trigger the population boom that some
suggested. Canine distemper provides a good model for studying whether a
disease regulates a population (Milius 1998). The cyclic nature of
enzootic rabies suggests that it causes significant changes in numbers
of animals, but direct evidence is fragmentary. Scientists have observed
for years that raccoon populations decrease during the initial epizootic
activities, but stabilize at pre-infestation levels after a few years
(McLean, pers. comm. 2004).

In Europe and Ontario, an increase in fox densities coincided with
reduction of rabies by oral vaccination, but was found to result from
ecological changes as much as or more than from rabies control;
increases occurred at the same times in regions which had no rabies
(MacInnes and LeBer 2000). An Ontario Ministry of Natural Resources
project trapped, vaccinated, and released skunks and raccoons for both
rabies and canine distemper in certain areas of the City of Scarborough,
Ontario. Researchers concluded that the vaccine had decreased the
prevalence of the diseases (1.4 percent of raccoons infected versus 8.3
percent prior to implementation of the program), yet the program did not
change overall growth trends in the raccoon population (Milius 1998).
Canine distemper may have impacts as large as or larger than rabies on
raccoon populations, but where measured explicitly during one outbreak
it had only small effects. Parvoviruses, infectious canine hepatitis,
and other viral diseases have potential to severely affect fox, skunk,
and raccoon populations. The whole question of the influence of disease
on wildlife numbers is complex and far from fully explained (MacInnes
and LeBer 2000). From what is currently known about the interaction of
the rabies virus and raccoons, significant changes in population numbers
due to the treatment of the rabies are not common (McLean, pers. comm.
2004).

Guerra et al. (2003) does not support the idea that rabies exists
specifically to control raccoon populations. Guerra et al. (2003) state
that after an initial peak, populations approach lower 'steady-state'
conditions. Based on surveillance data, raccoon rabies did not exist
outside a focus in Florida before the 1940s. Therefore, elimination of
raccoon rabies should merely create the scenario before raccoon rabies
spread in the eastern U.S. (Rupprecht and Smith, 1994). No evidence
exists that the carrying capacity for raccoons could be increased by the
implementation of ORVAC programs compared to population levels before
the introduction of rabies (C. Rupprecht, CDC, pers. comm. 2003).

Prior to the introduction of raccoon rabies into the mid-Atlantic region
in the late 1970's, canine distemper was considered a primary disease
mortality factor in raccoons, gray foxes, and skunks (Roscoe 1993,
Davidson et al. 1992). The epizootiology of canine distemper in raccoons
in New Jersey and Florida has been characterized by outbreaks at the end
of the mating season in March and with increased movements of young in
September (Roscoe 1993, Hoff et al. 1974). Because of the cyclic nature
of canine distemper outbreaks (4 year intervals), the wide distribution
of canine distemper cases, and the low incidence of the disease between
epizootic peaks in New Jersey, Roscoe (1993) proposed an enzootic status
for canine distemper for raccoons that becomes epizootic when raccoon
densities reach high levels. Evans (1982) found that 50 to 90 percent of
raccoons and gray foxes may be incapable of producing protective levels
of antibody against the canine distemper virus, implicating it as a
potentially important disease mortality factor. Davidson et al. (1992)
diagnosed canine distemper in 78 percent of gray foxes studied in the
southeastern U.S. and found canine distemper to be more significant as a
mortality factor for gray foxes than all other infectious and
noninfectious diseases combined. Roscoe (1993) reported that the effects
of canine distemper on raccoon populations may diminish if raccoon
rabies spreads and that concurrent canine distemper and rabies
epizootics may become more common. The dynamics of sympatric rabies and
canine distemper are not well understood; however, rabies may compensate
for deaths that would have historically occurred due to canine distemper
infection. Important attributes of canine distemper include that it is
not a zoonotic disease like rabies and it historically has been
implicated as a virus of importance to carnivore mortality.

As an omnivore, the raccoon may play an important role in community and
ecosystem interactions. In coastal ecosystems, such as Canaveral
National Seashore in Florida, raccoons may function as significant seed
dispersers and consumers of crustaceans, small fish, sea turtle
hatchlings, small mammals, and berries (Ratnaswamy and Warren 1998).
This prevalence of invertebrate prey and plant matter in coastal raccoon
diets is consistent with general observations made on raccoons
throughout their range. Thus, raccoons have ecological connections with
many components of the coastal biological community in addition to sea
turtle eggs and hatchlings (Ratnaswamy and Warren 1998). At Canaveral
National Seashore, lethal removal of approximately 50 percent of the
raccoon population using the nesting beach did not result in a
significant reduction of nest depredation (Ratnaswamy and Warren 1998).

In Ontario, it appears that human activities and disease have had no
significant impact on the survival of raccoons. Despite being subjected
to trapping, hunting, collisions with vehicles, infectious diseases, and
removal by animal control agencies, raccoon populations are thriving.
Also, habitat deterioration, habitat destruction, and urbanization seem
to have had little impact on limiting raccoon populations (Rosatte
2000). The most effective control measure is likely to be the reduction
or elimination of human-created food sources (e.g., covering refuse
containers, removing refuse before dusk), which support raccoons at
these high densities (Prange et al 2003). With raccoon population
numbers annually regulated by many different environmental factors,
including habitat, food, weather, disease, predation, and humans,
long-ranged assessments of the affects of raccoons on localized
ecological systems is difficult. For sites where raccoon populations
represent a threat to park resources, efforts must be taken annually to
address those threats.

[]{.mark}

The Parks of the Northeast Region of the NPS understand the potential
health significance of raccoon rabies on humans and other native animals
as it continues to expand into new areas of the northeastern U.S.
However, intervention into the biological activities of a natural system
for any reason is something that NPS managers do with great care. NPS
Management Policies require "that the environmental costs and benefits
of proposed operations, development, and resource management are fully
and openly evaluated before taking actions that may impact the natural
resources of parks. The evaluation must include appropriate
participation by the public; the application of scholarly, scientific,
and technical information in the planning, evaluation, and
decision-making processes; the use of NPS knowledge and expertise
through interdisciplinary teams, and processes; and the aggressive
incorporation of mitigation measures, pollution prevention techniques,
and other principles of sustainable park management." As the NPS
implements the ORVAC program within its parks, every effort will be made
to evaluate the park-specific benefits and impacts of the project. To
accomplish this goal, the NPS will work with APHIS-WS and other
cooperating agencies to assure that surveillance is carried out to track
raccoon populations, predation activities by raccoons, and to track
rabies prevalence in raccoon populations. Great care will be made to
protect native resources found in the parks, with a watchful eye on
resources that are rare, threatened, and endangered. Resources within
the NPS, for the collection of this information, are extremely limited
and would therefore be provided by APHIS-WS or other cooperators within
the national rabies management team.

In situations where diseases like West Nile Virus, Lyme Disease,
Hantavirus, and Raccoon Rabies could affect park resources, visitors,
and employees, the NPS is directed to seek the guidance of the U.S.
Public Health Service and CDC. The director of the CDC has indicated
that raccoon rabies presents a serious public health problem in the U.S.
(letter to APHIS-WS, dated May 29, 2001). Potential direct exposure to
rabid raccoons, or indirect exposure by a pet that had an encounter with
a rabid raccoon, creates this human health threat. The NPS Public Health
Program concurs with the CDC assessment that rabies is a significant
public health risk and that every reasonable effort should be made to
control the disease (M. Wild, NPS, pers. comm. 2004).

**2.2.7 Effects of Nontarget Species Consumption of ORVAC Baits on
Program Effectiveness**

Consumption of ORVAC baits by nontarget species is not expected to
impact program effectiveness. As described in section 1.1.3, baits are
developed to attract target species. The use of target preferred baits
increases the likelihood of the target species consuming the baits prior
to the discovery of baits by nontarget species. Furthermore, bait
distribution densities are developed to compensate for the uptake of
baits by nontarget species. Baits are distributed at densities that
allow raccoons the opportunity to come in contact with intact baits. It
has been determined based upon the success of ORVAC bait drops for
raccoons by the various state ORVAC programs in other parts of the three
involved states (PA, NJ, and WV), with similar wildlife species
composition as those found in the parks, that the distribution of 75
baits per square km would be sufficient to maintain program
effectiveness. []{.mark}

**2.2.8 Potential Impacts to Indian Trust Resources**

Secretarial Order 3175 requires that any anticipated impacts to Indian
trust resources from a proposed project or action by USDI agencies be
explicitly addressed in environmental documents. The federal Indian
trust responsibility is a legally enforceable fiduciary obligation on
the part of the United States to protect tribal lands, assets,
resources, and treaty rights, and it represents a duty to carry out the
mandates of federal law with respect to American Indian and Alaska
Native tribes.

There are no Indian trust resources in these units. The lands comprising
the units are not held in trust by the Secretary of the Interior for the
benefit of Indians due to their status as Indians. Therefore, the Indian
Trust Resources issue was dismissed as an impact topic.

Copies of this EA will be forwarded to each tribe traditionally
associated with each park unit's lands for review and comment. If the
tribes subsequently identify the presence of ethnographic resources,
appropriate mitigation measures would be undertaken if necessary in
consultation with the tribes. The location of ethnographic sites would
not be made public. In the unlikely event that human remains, funerary
objects, sacred objects, or objects of cultural patrimony are discovered
during the proposed program, provisions outlined in the Native American
Graves Protection and Repatriation Act (25 USC 3001) of 1990 would be
followed. Because there are no known ethnographic resources within the
project area, ethnographic resources issues were dismissed as an impact
topic. Also, since the ORVAC bait distribution does not involve any
ground disturbance, there is little or no potential for disturbance of
ethnographic resources.

9.  **Potential for Adverse Impacts on Lightscape**

The NPS strives to preserve the natural ambient landscapes, which are
natural resources and values that exist in the absence of human-caused
light. Recognizing the roles that light and dark periods play in natural
resource processes and the evolution of species, the NPS seeks to
protect natural darkness and other components of the natural lightscape
in parks. (NPS policy for this topic is found in *Management Policies*
*2001* (USDI 2000b), 4.10, Lightscape Management.)

The concern may be that the lightscape conditions in a national park
environment might be adversely affected by aircraft overflights during
ORVAC bait distribution. Aircraft overflights for ORVAC bait
distribution normally occur during daylight hours; however, certain
circumstances (e.g., to avoid dropping baits during peak visitor use
periods, security issues, etc.) may necessitate baiting outside of
daylight hours. Aerial ORVAC bait distribution activities would only
occur once per year and aircraft would only fly momentarily over any one
point on the ground. The aircraft do not circle over areas repeatedly,
but fly in straight "transect" lines for the purposes of bait
distribution. The potential impact would be of only momentary duration,
on a local scale, with negligible intensity. Therefore, this issue was
dismissed as an impact as it will have no chronic effect on lightscape
(see Section 2.2.1 for more information).

10. **Potential for Adverse Impacts on Soundscape**

An important part of the National Park Service mission is preservation
of natural soundscapes associated with national park units. The natural
ambient soundscape is the aggregate of all the natural sounds that occur
in parks, together with the physical capacity for transmitting natural
sounds. Natural sounds occur within and beyond the range of sounds that
humans can perceive and can be transmitted through air, water, or solid
materials. (NPS policy for this topic is found in DO-47, *Sound
Preservation and Noise Management* and *Management Policies 2001* (USDI
2000b), 4.9, Soundscape Management.)

The issue expressed here is that the natural soundscape of national park
units may be adversely affected by aircraft overflights during ORVAC
bait distribution activities. Aerial ORVAC bait distribution activities
would only occur once per year and aircraft would only fly momentarily
over any one point on the ground. The aircraft do not circle over areas
repeatedly, but fly in straight "transect" lines for the purposes of
bait distribution. Overflights are also conducted at a minimum of 500
feet above ground level. Additionally, the types of aircraft used in
bait distribution, the DeHavilland (DHC-6) Twin Otter and Beechcraft
King Air B200, meet all FAR requirements regarding noise limits (FAR
Part 36). The potential impact would be of extremely short-term
duration, on a local scale, with negligible intensity. Therefore, this
issue was dismissed as an impact as the ORVAC bait distribution
activities will have no chronic effect on soundscape (see Section 2.2.1
for more information). []{.mark}

11. **Potential for Adverse Impacts to Historical Properties**

The NHPA and its Implementing Regulations (36 CFR 800) require federal
agencies to: 1) determine whether activities they propose constitute
"undertakings" that can result in changes in the character or use of
historic properties and, 2) if so, to evaluate the effects of such
undertakings on such historic resources and consult with the State
Historic Preservation Office regarding the value and management of
specific cultural, archaeological and historic resources, and 3) consult
with appropriate American Indian tribes to determine whether they have
concerns for traditional cultural properties in areas of these federal
undertakings.

ORVAC activities described under the proposed action (Section 1.2) do
not cause major ground disturbance, do not cause any physical
destruction or damage to property, do not cause any alterations of
property, wildlife habitat, or landscapes, and do not involve the sale,
lease, or transfer of ownership of any property. In general, such
methods also do not have the potential to introduce visual, atmospheric,
or audible elements to areas in which they are used that could result in
effects on the character or use of historic properties. Therefore, the
methods that would be used under the proposed action are not generally
the types of activities that would have the potential to affect historic
properties. If an individual activity with the potential to affect
historic resources is planned under an alternative selected as a result
of a decision on this EA, then site-specific consultation as required by
Section 106 of the NHPA would be conducted as necessary.

The following state historical preservation officers have reviewed the
proposed ORVAC program and have indicated that the proposed program will
have no adverse effects on historic properties (copies of letters and
responses are located in the Administrative Record for this EA):

-   PA Historical and Museum Commission

-   NJ Department of Environmental Protection -- Historic Preservation
    Office

-   WV Division of Culture and History

**2.2.12 Potential for Adverse Impacts to Minority and Low-Income
Populations**

Executive Order 12898, Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations requires Federal
agencies to analyze disproportionately high and adverse environmental
effects of proposed actions on minority and low-income populations. NPS
has analyzed the effects of the proposed action and determined that
implementation would not have adverse human health or environmental
impacts on low-income or minority populations.

**2.2.13 Potential for Adverse Impacts to the Safety and Health of
Children**

Executive Order 13045 was passed to help protect children who may suffer
disproportionately from environmental health and safety risks for many
reasons. ORVAC activities as proposed in this EA would only involve
legally available and approved methods that have been subjected to
safety evaluations and testing. The vaccinia virus used as a carrier of
the rabies glycoprotein is the same type of virus that was used in
smallpox eradication, although more attenuated or weakened (USDA 1991,
p. 39). The analysis in this EA supports a conclusion of negligible to
no risk of adverse effects to children from the ORVAC baiting strategy.
Implementation of the proposed action would not increase environmental
health or safety risks to children, but would in fact reduce such risks
by minimizing the potential for children to contract rabies. Children
are particularly at risk from rabies because they are more prone to
experiencing "undetected" or "unappreciated" exposures (Huntley et al.
*unpublished* 1996) that do not lead to post-exposure vaccine
treatments. Therefore, federal involvement in ORVAC programs is
consistent with and helps to achieve the goals of EO 13045.

**Resource Values.** The following resource values would not be
significantly impacted by any of the alternatives analyzed: soils,
geology, minerals, water quality/quantity, flood plains, wetlands,
visual resources, air quality, prime and unique farmlands, aquatic
resources, timber, and range.

**Irreversible and Irretrievable Commitment of Resources.** Other than
minor uses of fuels for aircraft and motor vehicles and other materials,
there are no irreversible or irretrievable commitments of resources.

[]{.mark}

[]{.mark}

**3.0 CHAPTER 3: ALTERNATIVES**

**3.1 ALTERNATIVES CONSIDERED, INCLUDING THE PROPOSED ACTION**

**3.1.1 Alternative 1.** **Authorize an ORVAC Program -** **Proposed
Action (*this is the preferred alternative*)**

Under this alternative, NPS would authorize the inclusion of several NPS
units within the Eastern Rivers and Mountains Network Parks grouping
located in PA, NJ, and WV in the ongoing ORVAC program in the eastern
U.S. to create zones of vaccinated target species that would then serve
as barriers to eliminate and/or cease the further advancement of raccoon
rabies virus variants. Vaccination zones would be determined in
cooperation with state rabies task forces, state health departments,
and/or other agencies with jurisdiction over vaccine use and application
in wildlife and domestic animal species. The program would involve use
of APHIS-WS federal funds to purchase and distribute ORVAC baits. On an
annual basis, one treatment of ORVAC baits would be distributed by
aircraft (fixed-wing airplane or helicopter) and ground placement on
various park units within the ORVAC project area in PA, NJ, and WV. The
need to distribute baits on each of the parks would be accessed annually
and based on the most current distribution of rabies cases and the
expected direction of disease spread. The treatment would continue on a
reoccurring basis until the goals of the ORVAC program have been met. A
more detailed description of the proposed action can be found in Section
1.2 of this EA.

**3.1.2 Alternative 2**. **No Action**

This alternative would preclude the NPS from any involvement with an
ORVAC program at various NPS units within the Eastern Rivers and
Mountains Network Parks grouping located in PA, NJ, and WV (see Section
1.2 for a list of park units). However, APHIS-WS, involved state
agencies, and rabies task forces would continue the ORVAC program on
lands not managed by the NPS. The "No Action" alternative is a
procedural NEPA requirement (40 CFR 1502), is a viable and reasonable
alternative that could be selected, and serves as a basis for comparison
with the other alternatives.

**3.2 ALTERNATIVES DISMISSED FROM FURTHER ANALYSIS**

1.  **An ORVAC Program with Animal Specimen Collections for Monitoring
    Purposes**

Under this alternative, an ORVAC program would be implemented similar to
the proposed action but would also include the collection of wild animal
specimens from NPS lands for monitoring and project evaluation purposes
through the use of a variety of live capture or lethal methods including
shooting, leghold traps, cage traps, foot snares and wire cable neck
snares (USDA 2001a). The state ORVAC programs within PA, NJ, and WV
collect wild animals for monitoring purposes in other areas of each of
the three states (USDA 2004d). However, these state ORVAC programs have
determined that it would not be necessary to collect wild animals for
monitoring purposes on NPS units located in PA, NJ, and WV at this time
or within the foreseeable future. For this reason this alternative was
not considered further.

**3.2.2 Live-Capture-Vaccinate-Release Programs**

This alternative would involve the live capture of raccoons followed by
administration of rabies vaccines by injection and release back into the
wild. This strategy has been used in certain localized areas for
reducing the incidence and spread of rabies in raccoons (Brown and
Rupprecht 1990, Rosatte et al. 1990, Rosatte et al. 1992, Rosatte et al.
1993) and skunks (Rosatte et al. 1990, Rosatte et al. 1992, Rosatte et
al. 1993). Currently, no vaccine is specifically licensed for this type
of use (CDC 2000). However, certain injectable vaccines may be used
"off-label" under the direction of veterinarians to vaccinate wild
animal species in certain situations (Mitzel, APHIS-Veterinary Services,
pers. comm. 2001 *in* USDA 2001a). This method generally results in a
higher percentage of a raccoon population being vaccinated than ORVAC,
but takes much longer to accomplish in a given area. For example, in
Ontario, 7 trappers working from July to October were required to trap
and vaccinate 50-85 percent of the raccoons in an area less than 700
km.^2^, whereas the same area could have been treated with aerially
dropped ORVAC baits in half a day (C. MacInnes, Ontario Ministry of
Natural Resources, pers. comm. 2001). For these reasons this alternative
was not considered further.

**3.2.3** **Depopulation of Raccoons**

This alternative would result in the lethal removal of raccoons
throughout the zones where outbreaks of this variant of rabies virus is
occurring or is expected to occur. The goal would be to achieve
elimination of the raccoon rabies strain by severely suppressing
populations of raccoons over broad areas so this specific variant of
rabies could not be transmitted to other susceptible members of the same
species. This could theoretically stop the forward advance of the
disease and potentially result in elimination of the raccoon rabies
variants since infected animals would die from rabies before they could
transmit it to other members of the same species.

Population reduction is often suggested as a method to control rabies in
wildlife populations since the disease is density dependent (Debbie
1991). Bounty incentives, regulated hunting and trapping, ingestible
poisons, and fumigation of dens have all been employed to control
populations with varying levels of success. MacInnes (1998) reviewed
some of the past efforts to control rabies with population reduction of
carrier species and concluded that, with a couple of exceptions, most
such efforts have failed. In some of the situations, it could not be
determined whether an observed decline or disappearance of rabies cases
was attributable to population control work or to the disease simply
reaching some unexplainable geographical limitation or just dying out on
its own (MacInnes 1998). Also, population control as a strategy can be
questionable because the leading edges of rabies outbreaks do not
necessarily coincide with the edge of the range of the principal
"vectors" (e.g., raccoons, gray foxes, and coyotes), nor are they always
necessarily related to the population density of such vectors (MacInnes
1998).

The greatest difficulty with population reduction as a strategy for
reducing or eliminating rabies is that a high level of effort must be
maintained almost indefinitely (MacInnes 1998). Population suppression
can be a challenge to maintain in many situations due to immigration (of
other members of the same species from surrounding populations) and
compensatory reproduction (i.e., larger litters and greater percentages
of females breeding following population reduction) (Clark and Fritzell
1992, Connolly and Longhurst 1975). These two factors could result in
local populations recovering to their previous population level in a
relatively short period of time, thus requiring a sustained and frequent
suppression effort to maintain populations at the desired levels.

For these reasons, and because depopulation of the raccoon species would
be considered inconsistent with the NPS mission, this alternative was
not considered further.

**3.2.4 Employ Other Types of ORVAC instead of the V-RG Vaccine**

Under this alternative, the NPS would use or authorize the use of a
"modified-live-virus" (i.e., "attenuated" or weakened strains that have
been shown to have little chance of causing rabies in treated animals)
or perhaps "killed-virus" (i.e., "inactivated" virus) oral vaccines
instead of the V-RG vaccine. Modified-live-virus vaccines include those
that have been used in the past to vaccinate domestic animals by
injection in the U.S. Oral baits that employed several strains of these
types of virus vaccines have been investigated and used in Europe to
stop the spread of rabies in red foxes (Flamand et al. 1993, Artois et
al. 1993, Artois et al. 1997). They have also been tested in red foxes
in Canada (Lawson et al. 1989, Lawson et al. 1997), and in red foxes and
raccoons in the U.S. (Rupprecht et al. 1989, Rupprecht et al. 1992c).

The primary concern with attenuated or "live" virus vaccines (e.g., SAD
and ERA) is that they can sometimes cause rabies (Flamand et al. 1993,
Pastoret et al. 1992). Flamand et al. (1993) reported that one strain
used widely in oral baits in Europe to vaccinate wild red foxes in the
1970s could cause rabies in rodents when injected and that the ability
to cause rabies in nontarget animals by other modes (i.e., oral
administration) could not be ruled out. Previously used attenuated
strains are also "heat sensitive" which can limit their use in warmer
seasons or climates (Pastoret et al. 1992). These types of safety
concerns with attenuated rabies virus vaccines have been sufficient to
prevent their approval for use in the U.S. (Rupprecht et al. 1992c).

Inactivated or "killed" virus rabies vaccines are safer than "live"
vaccines in that they cannot cause rabies. This type of vaccine was
found to be less effective in causing immunity when delivered into the
intestinal tract in foxes (only 30 percent effective in test animals)
and took 2 doses to cause immunity in the foxes that were successfully
immunized (Lawson et al. 1989). Also, the amounts of virus particles
that would have to be ingested in oral baits by wild carnivores to
effectively vaccinate them would be 100 to 1000 times the amount of the
live-attenuated virus particles required (Rupprecht et al. 1992c). To
manufacture vaccines with these amounts would probably be
cost-prohibitive (Rupprecht et al. 1992c).

Currently, RABORAL V-RG is the only vaccine licensed for use in raccoons
in the U.S. (CDC 2000). For all of the above reasons, this alternative
was not considered further.

**3.3 MITIGATION IN STANDARD OPERATING PROCEDURES FOR RABIES ORVAC
PROGRAMS**

Mitigation measures are any features of an action that serve to prevent,
reduce, or compensate for impacts that otherwise might result from that
action.

A number of key mitigating measures are currently part of the standard
operating procedures of state-operated ORVAC programs and would be used
as part of the ORVAC program on NPS lands. These include:

-   Public information and education actions and media announcements to
    inform the public about ORVAC bait distribution activities before
    they occur.

-   Toll-free telephone numbers advertised in the media and on web sites
    for people to call for answers to questions.

-   In the unlikely event of an adverse vaccinia virus exposure in
    humans, the CDC can make vaccinia immune globulin available to a
    state on a case-by-case basis to provide a level of additional
    assurance that such a reaction would be successfully treated.

-   Training of bait distribution navigators to avoid dropping baits on
    people, structures, and large bodies of water (lakes, reservoirs,
    rivers). During aerial bait drop operations, the bait dispensing
    equipment is temporarily turned off over large bodies of water,
    human dwellings, and when people are observed below. Every effort
    would be made to drop baits during off-peak visitor use at NPS
    units.

-   ORVAC baits would not be distributed by aircraft within 1/4 mile of
    water bodies to reduce the potential of baits entering the water
    source.

-   Adherence of aircraft to air safety standards.

-   Training of personnel in hand distribution of baits to avoid
    properties with greater risk of human or pet encounters with baits.

-   Labels are affixed to each ORVAC bait instructing persons not to
    disturb or handle them and contain a toll-free telephone number to
    call for further information and guidance in the event of accidental
    exposure to the vaccine.

-   Education campaigns by state and local health departments, the CDC,
    APHIS-WS, Cornell and Tufts Universities, and others are already
    occurring in conjunction with the ORVAC program to teach the general
    public about rabies prevention and risks (see sample press release
    in Appendix F or go to the CDC's website at <http://www.cdc.gov/> or
    APHIS-WS' website at
    <http://www.aphis.usda.gov/ws/rabies/index.html> to learn more about
    rabies and its prevention).

[]{.mark}

-   The Communication Planning Team, part of the Rabies Management Team,
    is developing a means to enhance interaction with the public on
    ORVAC, including web site creation. However, an immediate charge for
    this team is to bring together all key interests including raccoon
    hunters, dog trainers, rehabilitators, nuisance wildlife control
    operators, and agency personnel to seriously address translocation
    of rabies reservoir species, which could jeopardize national efforts
    to control terrestrial variants of rabies (Slate et al. 2002; R.
    Chipman, APHIS-WS, pers. comm. 2004). Translocation of raccoons from
    the southeastern U.S. to western Virginia and West Virginia in the
    late 1970s was the probable origin of the epizootic mid-Atlantic
    region that had not formerly experienced raccoon rabies (Nettles et
    al. 1979, Slate et al. 2002).

**3.4 ENVIRONMENTALLY PREFERRED ALTERNATIVE**

The environmentally preferred alternative is determined by applying the
criteria suggested in Section 101 of the National Environmental Policy
Act which states that "...it is the continuing responsibility of the
federal government to...(1) fulfill the responsibilities of each
generation as trustee of the environment for succeeding generations; (2)
assure for all Americans safe, healthful, productive, and aesthetically
and culturally pleasing surroundings; (3) attain the widest range of
beneficial uses of the environment without degradation, risk to health
or safety, or other undesirable and unintended consequences; (4)
preserve important historic, cultural, and natural aspects of our
national heritage, and maintain, wherever possible, an environment which
supports diversity, and variety of individual choice; (5) achieve a
balance between population and resource use which will permit high
standards of living and a wide sharing of life's amenities; and (6)
enhance the quality of renewable resources and approach the maximum
attainable recycling of depletable resources."

Alternative 1, the Proposed Action, is the environmentally preferred
alternative. Alternative 1 is believed to be the least environmentally
intrusive alternative available for achieving the goals of eliminating
and stopping the forward (northward and westward) advance of the raccoon
strain of rabies in the eastern U.S. and reducing the incidence of
rabies cases involving wild and domestic animals and rabies exposures to
humans. Alternative 1 surpasses the other alternative (no action) by
recognizing the range of national environmental policy goals as stated
in Section 101 of the National Environmental Policy Act. Alternative 1
integrates "...safe, healthful....surroundings" with resource
protection.

**Table 3-1. Comparative Summary of Environmental Impacts**

  ----------------------- ----------------------- -----------------------
  **Issue**               **Expected Impacts by   
                          Alternative**           

                          **Alternative 1.**      **Alternative 2**. **No
                          **Authorize an ORVAC    action**.
                          Program -** **Proposed  
                          action (*this is the    
                          preferred               
                          alternative*).**        

  **Potential for adverse Negligible adverse      No impact from being
  effects on people that  impacts from humans     exposed to baits or
  become exposed to the   being exposed to baits  vaccine. Potential
  vaccine or the baits.** and vaccine. Reduced    moderate, adverse
                          threat of human         impacts from risk of
                          exposure to the rabies  human exposure to
                          virus.                  rabies.

  **Effects of the ORVAC  No adverse impacts.     No impact from being
  V-RG vaccine on         Beneficial impact from  exposed to bait or
  raccoons.**             immunizing raccoons     vaccine. Potential
                          against rabies.         moderate, adverse
                                                  impacts from continued
                                                  exposure to and
                                                  possibility of
                                                  acquiring rabies.

  **Potential for adverse No adverse impacts.     No impact from being
  effects on nontarget    Potential minor         exposed to bait or
  wildlife species,       beneficial impact by    vaccine. Potential
  including threatened or possibly immunizing     moderate, adverse
  endangered species.**   wildlife species        impacts from continued
                          against rabies.         exposure to and
                                                  possibility of
                                                  acquiring rabies.

  **Potential for adverse No adverse impacts.     No impact from exposure
  effects on pet dogs or  Potential minor         to baits or vaccine.
  other domestic animals  beneficial impact by    Potential moderate,
  that might consume the  possibly immunizing     adverse impacts from
  baits.**                domestic animals        continued exposure to
                          against rabies.         and possibility of
                                                  acquiring rabies.

  **Potential for the     Negligible risk of      No impact.
  recombined V-RG virus   adverse impacts.        
  to "revert to                                   
  virulence" and result                           
  in a virus that could                           
  cause disease in humans                         
  or animals.**                                   

  **Potential for the     Negligible risk of      No impact.
  V-RG virus to recombine adverse impacts.        
  with other viruses in                           
  the wild to form new                            
  viruses that could                              
  cause disease in humans                         
  or animal**                                     

  **Potential for         Negligible risk of      No impact.
  aerially dropped baits  adverse impacts.        
  to strike and injure                            
  people or domestic                              
  animals.**                                      

  **Potential impacts on  Negligible impact from  No impact from
  visitor                 distribution of ORVAC   distribution of ORVAC
  use/experience**        baits. Beneficial       baits. Potential
                          impact by reducing the  moderate, adverse
                          threat of being exposed impacts from threat of
                          to a rabid animal.      being exposed to a
                                                  rabid animal.
  ----------------------- ----------------------- -----------------------

**Table 3-2. Comparative Summary of Alternatives and Extent to which
Each Alternative Meets the Project Objectives.**

+-----------------------------------+-----------------------------------+
| **Alternative 1. Authorize an     | **Alternative 2. No Action.**     |
| ORVAC Program -- Proposed Action  |                                   |
| *(this is the preferred           |                                   |
| alternative)*.**                  |                                   |
+-----------------------------------+-----------------------------------+
| This alternative would involve    | This alternative would preclude   |
| NPS participation in ORVAC        | the NPS from any involvement with |
| programs at several NPS units     | an ORVAC program at park units    |
| located in PA, NJ, and WV to      | located in PA, NJ, and WV.        |
| create zones of vaccinated target |                                   |
| species that would then serve as  | **Meets Project Objectives?**     |
| barriers to eliminate and/or      |                                   |
| cease the further advancement of  | No. The NPS would not assist the  |
| raccoon rabies virus variants.    | states of PA, NJ, and WV in       |
| The NPS units may include the     | stopping the forward advance of   |
| following:                        | the raccoon strain of rabies in   |
|                                   | the eastern U.S. The NPS would    |
| Northeast Region's Eastern Rivers | not assist the states of PA, NJ,  |
| and Mountains Network Parks:      | and WV in reducing the incidence  |
|                                   | of rabies cases in wildlife and   |
| Allegheny Portage Railroad        | domestic animals and rabies       |
| National Historic Site, PA        | exposures to humans.              |
|                                   |                                   |
| Delaware Water Gap National       |                                   |
| Recreation Area, PA & NJ          |                                   |
|                                   |                                   |
| Fort Necessity National           |                                   |
| Battlefield, PA                   |                                   |
|                                   |                                   |
| Friendship Hill National Historic |                                   |
| Site, PA                          |                                   |
|                                   |                                   |
| Johnstown Flood National          |                                   |
| Memorial, PA                      |                                   |
|                                   |                                   |
| Bluestone National Scenic River,  |                                   |
| WV                                |                                   |
|                                   |                                   |
| Gauley River National Recreation  |                                   |
| Area, WV                          |                                   |
|                                   |                                   |
| New River Gorge National River,   |                                   |
| WV                                |                                   |
|                                   |                                   |
| Vaccination zones would be        |                                   |
| determined in cooperation with    |                                   |
| the involved states' rabies task  |                                   |
| forces, state health departments, |                                   |
| and/or other agencies with        |                                   |
| jurisdiction over vaccine use and |                                   |
| application in wildlife and       |                                   |
| domestic animal species. The      |                                   |
| program would involve the use of  |                                   |
| APHIS-WS federal funds to         |                                   |
| purchase and distribute ORVAC     |                                   |
| baits.                            |                                   |
|                                   |                                   |
| On an annual basis, one treatment |                                   |
| of ORVAC baits could be           |                                   |
| distributed by aircraft and       |                                   |
| ground placement on involved NPS  |                                   |
| units in PA, NJ, and WV. The need |                                   |
| to distribute baits on each of    |                                   |
| the parks would be accessed       |                                   |
| annually and based on the most    |                                   |
| current distribution of rabies    |                                   |
| cases and the expected direction  |                                   |
| of disease spread. The treatment  |                                   |
| would continue on a reoccurring   |                                   |
| basis until the goals of the      |                                   |
| ORVAC program have been met.      |                                   |
|                                   |                                   |
| **Meets Project Objectives?**     |                                   |
|                                   |                                   |
| Yes. The NPS would assist the     |                                   |
| states of PA, NJ, and WV in       |                                   |
| stopping the forward advance of   |                                   |
| the raccoon strain of rabies in   |                                   |
| the eastern U.S. by immunizing    |                                   |
| portions of target species        |                                   |
| populations along the leading     |                                   |
| edges of the rabies fronts,       |                                   |
| within the aforementioned NPS     |                                   |
| units located in these three      |                                   |
| states. The NPS would assist the  |                                   |
| states of PA, NJ, and WV in       |                                   |
| reducing the incidence of rabies  |                                   |
| cases involving wild and domestic |                                   |
| animals and rabies exposures to   |                                   |
| humans in the areas where the     |                                   |
| ORVAC programs are conducted.     |                                   |
+-----------------------------------+-----------------------------------+

**4.0 CHAPTER 4: AFFECTED ENVIRONMENT**

This section presents some descriptive information on the environment of
the areas that would be affected by the proposed action. Other
descriptive aspects of the affected environment are included in Chapter
4 in the analysis of effects which is based on the environmental and
other types of issues identified in section 2.1.

"Major Habitat Types" as described by Ricketts et al. (1999) that
encompass the three states (PA, NJ, and WV) that would be affected by
ORVAC programs under the proposed action are: Temperate Broadleaf and
Mixed Forests. Appendix E shows the "ecoregions" (i.e., broad level
ecosystems) that occur in the potentially affected states (Bailey 1995).
Ecoregions in these states range from Laurentian Mixed Forests to
Eastern Broadleaf Forests to Central Appalachian Broadleaf Forests.

1.  **Potentially Affected NPS Units in the Eastern Rivers and Mountains
    Network Parks Grouping**

[]{.mark}

**Allegheny Portage Railroad National Historic Site, PA**

The Allegheny Portage Railroad was the first railroad constructed over
the Allegheny Mountains in southwestern Pennsylvania. This inclined
plane railroad operated between 1834 and 1854 and was considered a
technological wonder in its day. It played a critical role in opening
the interior of the U.S. to trade and settlement. This national historic
site was created on August 31, 1964 and over 1249 acres to preserve the
remains of the first railroad to cross the Alleghenies.

**Delaware Water Gap National Recreation Area, PA & NJ**

The Delaware Water Gap was designated a national recreation area on
September 1, 1965 and a national scenic river on November 10, 1978. This
park preserves 40 miles of the middle Delaware River and almost 70,000
acres of land along the river's New Jersey and Pennsylvania shores. At
the south end of the park, the river cuts eastward through the
Appalachian Mountains at the Delaware Water Gap. Over 5 million visitors
utilize the park each year for canoeing, hiking, camping, swimming,
picnicking, bicycling, cross-country skiing, horseback riding, fishing,
and hunting.

**Fort Necessity National Battlefield, PA**

This national battlefield site was created on March 4, 1931 within the
War Department. It was transferred to the NPS on August 10, 1933, and
designated a national battlefield on October 26, 1974. This national
battlefield preserves the opening battle of the French and Indian War
which began a seven year struggle between Great Britain and France for
control of North America. On July 3, 1754, Colonial troops commanded by
22-year-old Colonel George Washington were defeated in this small
stockade at the "Great Meadow." Great Britain's success in this war
helped pave the way for the American Revolution. Fort Necessity National
Battlefield is located in the mountains of southwestern Pennsylvania,
about 11 miles east of Uniontown. The park comprises approximately 900
acres in three separate sites. The main unit contains the visitor
center, the battlefield with the reconstructed Fort Necessity, and the
Mount Washington Tavern. The Braddock Grave unit is approximately 1.5
miles west of the main unit and the Jumonville Glen unit is 7 miles
northwest of the main unit.

**Friendship Hill National Historic Site, PA**

This 675-acre historic site was established on November, 10, 1978 to
preserve the country estate of Albert Gallatin, a Swiss emigrant who
served his adopted nation during the early years of the republic. Albert
Gallatin is best remembered for his thirteen year tenure as Secretary of
the Treasury during the Jefferson and Madison administrations in which
he reduced the national debt, purchased the Louisiana Territory and
funded the Lewis and Clark exploration. The Friendship Hill home is the
restored frontier home of Albert Gallatin and is located on the banks of
the Monongahela River in southwestern PA.

**Johnstown Flood National Memorial, PA**

The Johnstown Flood National Memorial was created on August 31, 1964 to
preserve the remains of the South Fork Dam and portions of the former
Lake Conemaugh bed near Johnstown, PA. On May 31, 1889, the South Fork
Dam failed during a storm and flooded the Conemaugh Valley, killing
2,209 people, in one of the worst disasters in our Nation's history.

**Bluestone National Scenic River, WV**

This scenic river was designated on October 26, 1988 and preserves
relatively unspoiled land in southern West Virginia. In this park's
4,300 acres, it contains natural and historic features of the
Appalachian plateau and offers 11 miles of excellent warm water fishing,
hiking, boating, and scenery to the 55,000 visitors each year.

**Gauley River National Recreation Area, WV**

Gauley River National Recreation Area was established in 1988 to
preserve 25 miles of free-flowing Gauley River and six miles of the
Meadow River as they pass through scenic gorges and valleys containing a
wide variety of natural and cultural features. Located in southern West
Virginia, this unit of the NPS system encompasses over 11,000 acres of
land and is located between the towns of Summersville and Fayetteville,
WV. The Gauley River is a rugged, white water river which contains
several class V+ rapids and provides a variety of opportunities for
hiking, boating, and fishing to more than 200,000 people a year.

**New River Gorge National River, WV**

The New River Gorge National River is located in southern West Virginia
and was established on November 10, 1978 to preserve and protect 53
miles of the New River as a free-flowing waterway. It was also
designated an American Heritage River on July 30, 1998. This unit of the
NPS system encompasses over 70,000 acres of land along the New River
between the towns of Hinton and Fayetteville. The park and the
surrounding area are rich in cultural and natural history and contain an
abundance of scenic and recreational opportunities.

**5.0 CHAPTER 5: ENVIRONMENTAL CONSEQUENCES**

**Methodology for Assessing Impacts**

This section analyzes potential environmental consequences using
Alternative 2 (No Action alternative) as the baseline for comparison
with the other alternatives to determine if the real or potential
impacts are greater, lesser or the same. Table 3-1 summarizes a
comparison of the issues and impacts to each alternative.

Potential impacts are described in terms of context (are the effects
site-specific, local, or even regional?), duration (short- or
long-term?), and intensity (negligible, minor, moderate, or major?). The
thresholds of change for the intensity of an impact are defined as
follows:

-   **Negligible**-the impact is at the lowest levels of detection

-   **Minor**-the impact is slight, but detectable

-   **Moderate**-the impact is readily apparent

-   **Major**-the impact is a severe or adverse impact or of exceptional
    benefit

In addition to determining the environmental consequences of the
preferred and other alternatives, NPS (*Management Policies 2001*)
requires analysis of potential effects to determine whether or not
actions would impair park resources.

The fundamental purpose of the National Park System, established by the
Organic Act of 1916 and reaffirmed by the General Authorities Act, as
amended, begins with a mandate to conserve park resources and values.
NPS managers must always seek ways to avoid, or to minimize to the
greatest degree practicable, adverse impacts on park resources and
values. However, the laws do give the NPS the management discretion to
allow impacts to park resources and values when necessary and
appropriate to fulfill the purposes of a park, as long as the impact
does not constitute impairment of the affected resources and values.
Although Congress has given the NPS the management discretion to allow
certain impacts within parks, that discretion is limited by the
statutory requirement that the NPS must leave park resources and values
unimpaired, unless a particular law directly and specifically provides
otherwise. The prohibited impairment is an impact that, in the
professional judgment of the responsible NPS manager, would harm the
integrity of park resources or values, including the opportunities that
otherwise would be present for the enjoyment of those resources or
values. An impact to any park resource or value may constitute an
impairment. An impact would be more likely to constitute an impairment
to the extent it affects a resource or value whose conservation is:

[]{.mark}

-   Necessary to fulfill specific purposes identified in the
    establishing legislation or proclamation of the park;

-   Key to the natural or cultural integrity of the park or to
    opportunities for enjoyment of the park; or

-   Identified as a goal in the park's general management plan or other
    relevant NPS planning documents.

Impairment may result from NPS activities in managing the park, visitor
activities, or activities undertaken by concessioners, contractors, and
others operating in the park.

**Cumulative Impacts.** The Council on Environmental Quality (CEQ),
which implements the National Environmental Policy Act, requires
assessment of cumulative impacts in the decision‑making process for
federal projects. Cumulative impacts are defined as \"the impact on the
environment which results from the incremental impact of the action when
added to other past, present, and reasonably foreseeable future actions
regardless of what agency (federal or non-federal) or person undertakes
such other actions\" (40 CFR 1508.7). Cumulative impacts are considered
for both the no-action and proposed action alternatives.

[]{.mark}

Cumulative impacts were determined by combining the impacts of the
proposed alternative with potential other past, present, and reasonably
foreseeable future actions. Therefore it was necessary to identify other
ongoing or foreseeable future projects affecting these units and, if
applicable, the surrounding region. No reasonably foreseeable future
projects are anticipated which, in combination with the proposed
project, may impact the NPS units listed in this document (see Section
1.2 for a list of park units). However, occasional overflights (i.e.,
radio telemetry, GIS mapping, military training routes) may occur over
park units. Overflights for the purposes of ORVAC bait distribution
activities would only occur once per year and aircraft will only fly
momentarily over one point on the ground. The aircraft do not circle
over areas repeatedly, but fly in straight "transect" lines for the
purposes of bait distribution. The potential impact would be of
short-term duration, on a local scale, with negligible intensity.
Therefore, cumulative impacts from the combination of ORVAC bait
distribution overflights and other park unit overflights should be
negligible (see Chapter 2 for additional information).

1.  **Potential for Adverse Effects on People that Become Exposed to the
    Vaccine or the Baits**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

Direct tests of the safety of V-RG in humans have not been conducted,
for understandable reasons. Prior EAs by APHIS have analyzed in detail
the potential for adverse effects on humans from V-RG exposure as a
result of ORVAC experimental programs (USDA 1991, 1992).

**Potential to Cause Rabies in Humans**

The nature of the recombinant virus used as the V-RG vaccine is such
that it cannot cause rabies. This is because the V-RG vaccine only
carries the gene for producing the outer coating of the rabies virus
(i.e., rabies virus *glycoprotein*) and not those portions of the virus
that could result in replication of the rabies virus. Replication of the
virus would be necessary for the disease to occur.

Implementation of the ORVAC program would reduce the risk of humans
contracting rabies by reducing the chance of encountering rabid animals
that have been infected by the raccoon variant of the disease.

**Potential for Vaccinia Virus to Cause Disease in Humans**

The vaccinia virus portion of the V-RG vaccine has been recognized as
having the potential to cause infections in persons exposed to the
vaccine, either through direct contact with the liquid or through
contact with the mouth of an animal that has recently ingested the oral
vaccine (USDA 1991, p. 39). Because the vaccinia virus used in the V-RG
vaccine is the same type of virus that was used in smallpox eradication,
although more *attenuated* or weakened, persons who have been immunized
against smallpox would likely not experience any adverse reaction to the
vaccinia virus, but would likely experience at worst a "booster" in
immunity against vaccinia virus. However, the routine administration of
smallpox vaccinations was discontinued after smallpox was eradicated.
Thus, a large percentage of the population (particularly younger
individuals) has not been vaccinated against vaccinia. Vaccinia virus
rarely poses much risk of serious health effects -- even when it was
*directly applied* (via "scarification" or by scratching the skin) to
many hundreds of millions of people during smallpox eradication
campaigns, the number that developed vaccinia virus-related illness was
only a few per million. In most of those cases the extent of the illness
was a mild fever and some lesions or pustules at the site of the
injection, followed by full recovery and subsequent immunity to the
vaccinia virus (USDA 1991, p. 39; Elvinger 2001). In most people,
localized lesions occurred around the site on the arm where the smallpox
vaccine was applied, but this a normal and expected response and, in
general, no cause for concern.

More severe complications involving the central nervous system (CNS) can
occur with vaccinia virus and are generally thought to be allergic in
nature (USDA 1991, p. 39). CNS complications occurred at an average rate
of 3 per million among persons vaccinated with vaccinia virus (e.g., to
prevent smallpox) with about 10 to 30 percent of those cases resulting
in death (USDA 1991, p. 39). Thus, the chance of a person dying from
direct application of a high dose of vaccinia virus via scarification
would be about 1 in a million cases or less. With ORVAC baits
distributed in the wild, people would run far less risk of being exposed
to vaccinia virus or the V-RG vaccine in a way similar to deliberate
smallpox vaccinations, but would primarily only run the risk of skin
contact by handling broken baits or coming into contact with the oral
regions of pets that had just consumed a bait. For that type of
exposure, the chance of adverse effects from human infection with
vaccinia virus would be far less than 1 in a million.

Another highly important characteristic of the V-RG vaccine is that it
is weaker (more "attenuated") than the original parent vaccinia strain
used in making it (USDA 1991, p. 18-19). This characteristic even
further reduces the risk of V-RG vaccine causing vaccinia-related
illness in humans.

Persons with immune system deficiencies (e.g., AIDS) run a relatively
greater risk of experiencing adverse effects if directly exposed to the
vaccinia virus than would persons with normal immune systems (USDA 1991,
p. 40; USDA 1995a; USDA *undated a and undated b*). Experiments in mice
suggest that immune-deficient people would be at minimal risk of adverse
effects when exposed to V-RG vaccine (Hanlon et al. 1997; USDA 1991, p.
41 and Appendix E therein). To aid in further minimizing the potential
for adverse effects on humans because of contact with V-RG vaccine, each
ORVAC bait contains a warning label advising persons who make contact
with baits or the vaccine liquid to contact officials. A telephone
number is provided on the bait for further guidance.

An indirect source of information on this issue is the safety record of
laboratories that have worked with the V-RG vaccine (USDA 1991, p. 27).
Ordinarily, lab personnel working with infectious materials or animals
are protected by immunization and by procedures and equipment that
minimize risk. V-RG vaccine has been completely safe for humans in
laboratory situations (USDA 1991, p. 27). Potential non-laboratory
exposure of humans in the various European field trials of V-RG vaccine
has been considerable, with no program in place that monitors antibody
levels of residents before and after the field trials. However, there
have not been any reports of increased incidence of sickness in the
field trial areas that could be attributable to the V-RG vaccine (USDA
1991, p. 27; Moore, TX Dept. of Health, pers. comm. 2001 *in* USDA
2001a).

Studies of the effects of V-RG vaccine on nonhuman primates can provide
an indication of the potential to affect humans (USDA 1991, p. 27).
Studies in which squirrel monkeys (*Saimiri sciureus*) and chimpanzees
(*Pan troglodytes*) were inoculated with the V-RG vaccine demonstrated
that indirect human exposure to the vaccine that might occur via a bite
or from contact with body fluids of a recently vaccinated animal is
unlikely to produce adverse effects in healthy individuals (Rupprecht et
al. 1992b, USDA 1991, p. 27).

McGuill et al. (1998) conducted a retrospective 4-year survey of
directors of five ORVAC programs that used the V-RG vaccine from
1992-1996 to evaluate the potential for human health problems. The
programs occurred in Florida, Massachusetts, New Jersey, New York, and
Texas. Altogether, they involved a total of 42,181 sq miles of treated
area and a total of nearly 6 million baits distributed. Human contacts
with the baits totaled 316, of which 53 resulted in contact with the
actual vaccine liquid. The directors of all programs reported that human
contact was minimal and that there were no reported adverse reactions in
people exposed to the baits. Human contact with the baits was more
likely in areas where bait had white labels vs. lettering in black ink,
and the authors speculated the reason to be because the white labeled
baits were more visible and thus more likely to be noticed. The authors
concluded that, based on their survey, major concerns about public
health risks from V-RG vaccine were unfounded.

Out of approximately 43.75 million baits disbursed since APHIS-WS ORVAC
program inception in 1995, only 576 people reported contacting or
potentially contacting a bait (i.e., picking up bait, finding a bait in
yard, or removing bait or sachet from pet's mouth, feces, or vomit - any
type of contact with a bait is also defined throughout the document as
an "exposure"). This equates to one human exposure per 75,955 baits
distributed (0.0013 percent contact cases). In addition, exposure cases
were generally insignificant as most involved finding an intact bait.
Very few cases involved touching a broken bait, sachet, or liquid
vaccine. Furthermore, of the 0.0013 percent of contact cases reported
since APHIS-WS ORVAC program inception in 1995, only one known adverse
reaction has occurred (USDA 2004e, 2004b).

The adverse reaction occurred in Ohio in September, 2000, when a woman
was bitten by her dog while trying to take away an ORVAC bait. The
vaccine liquid was exposed to the bite area, resulting in localized
inflammation and pox virus lesions at the site of the bite, as well as a
whole body rash. She further experienced sloughing of the outer layers
of skin from some portions of her body, similar to what occurs in the
skin condition eczema (C. Rupprecht, CDC, pers. comm. 2001). The woman,
who was in her first trimester of pregnancy, is reported to have
recovered from complications and gave birth to a 10-lb. baby boy with no
apparent adverse health effects (R. Krogwold, OH Dept. of Health, pers.
comm. 2001). Most recent reports attribute her response to the vaccinia
virus as likely due to the reduced state of immunity typical during
pregnancy and an underlying skin disorder (epidermolytic hyperkeratosis)
that the woman already had (C. Rupprecht, CDC, pers. comm. 2001). The
woman also tested positive for rabies antibodies three weeks after the
exposure, indicating she may also have developed rabies immunity
(Rupprecht et al. *unpublished* 2001, Rupprecht et al. 2001). A lawsuit
was filed in 2001 and a judgment was determined in favor of the
defendant, the Ohio Department of Health, in May 2003. This type of
incident appears to be unusual, but, nevertheless, points to the need
for continued public information and education activities and field
surveillance for accidental human exposure to the V-RG virus.

Recent bait exposure information during an ORVAC project in western
Pennsylvania (August-September, 2003) revealed that out of 1,710,399
baits distributed over approximately 25,189 km^2^, 190 humans or pets
were exposed to a bait. This equates to one exposure per 9,002 baits
disbursed or 0.011 percent of distributed baits being found by pets or
people. In at least 69 of the 190 potential contact cases, the household
pet (dog or cat) found the bait; however, the bait and sachet or sachet
alone was normally still intact (at least 91 percent of cases). Of the
six cases where the sachet was ruptured, no reports were submitted
regarding the development of an adverse reaction (i.e., lesions) (USDA
2004b). This ORVAC project involved hand baiting in several urban areas
such as Allegheny County, and aerial baiting of the rural areas.
Therefore, pets and other domestic animals were more likely to find the
baits and are the primary source for potential and human exposure to
ORVAC baits. Most ORVAC baiting locations occur over rural or
undeveloped lands where human exposure cases can be expected to be much
lower.

Although there is no approved anti-viral compound available yet for
treatment of suspected vaccinia virus complications, the CDC can make
vaccinia immune globulin available to states on a case-by-case basis,
with a requirement that certain specimens (such as acute and
convalescent sera and swabs/scabs of the affected site) be collected for
diagnosis (C. Rupprecht, CDC, pers. comm. 2001 *in* USDA 2001a). This
option provides some level of additional assurance that severe adverse
effects on humans from vaccinia virus reactions would be successfully
treated to avoid significant public health problems.

A recent study indicates vaccinia virus that originated from a strain
used in smallpox vaccinations in Brazil may have become established in
domestic cows in that country (Damaso et al. 2000). This indicates there
is some potential for the use of vaccinia virus to result in a new
emerging infectious disease. There is currently no evidence that this
type of phenomenon has occurred in the U.S. (C. Rupprecht, CDC, pers.
comm. 2001 *in* USDA 2001a). Also, the vaccinia virus strain used for
smallpox vaccination in Brazil was different than the strain that is
currently used in the V-RG vaccine, and the vaccinia virus portion of
V-RG is more attenuated (i.e., *weaker*) than the strains used in
smallpox vaccines (USDA 1991, p. 18-19). Thus, it is less likely that
V-RG vaccine would result in the establishment and persistence of
vaccinia virus in wild or domestic animals. However, no surveillance or
testing of animals for this virus has been done in the U.S. to test this
hypothesis (C. Rupprecht, CDC, pers. comm. 2001 *in* USDA 2001a).

The above information shows there is some potential for unusual
circumstances to result in short-term adverse health effects from
exposure to the vaccinia virus in the V-RG vaccine. However, the overall
risk of such effects appears to be negligible based on the extremely low
rate of reported occurrences in ORVAC programs.

**Potential to Cause Cancer (Oncogenicity)**

This issue has been addressed in a previous EA and in formal risk
analyses (USDA 1991, p. 40; USDA *undated a, undated b*). Vaccinia virus
is not known to be a tumor-inducing virus. There have been no documented
reports of oncogenicity associated with natural vaccinia virus
infections in any animal species. The recombinant DNA methods used for
preparation of the V-RG vaccine do not introduce any known oncogenes
(i.e., cancer-causing genes) into the vaccinia virus strain that could
cause it to become tumor-inducing.

[Cumulative Impacts:]{.underline} Cumulative impacts of the proposed
ORVAC program would likely be beneficial given that the possibility of
humans becoming exposed to raccoon variant of the rabies virus would be
reduced with this program. The ORVAC vaccine and bait that would be used
has a negligible risk of causing adverse affects to humans. A limited
number of baits would be distributed one time per year on an annual
basis, thereby limiting the amount of exposure a person may have to an
ORVAC bait or bait distributing equipment. Cumulative impacts to humans
would likely be beneficial. Any adverse impacts to humans from exposure
to the vaccine or baits would be negligible.

[Conclusion:]{.underline} Based on this information, risks to humans
from contact with the V-RG vaccine are believed to be negligible. The
risk and potential severity of adverse effects from rabies exposures in
humans would probably be greater without ORVAC programs than would be
the risk of serious adverse effects from vaccinia virus infections with
ORVAC programs. Implementation of an ORVAC program would likely have a
beneficial impact to humans. This alternative would support the states
of PA, NJ, and WV in the effort of reducing or possibly eliminating of
this strain of the virus from the eastern U.S.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

**Potential to Cause Rabies in Humans**

The risk of humans being exposed to the vaccine or baits would not occur
since ORVAC baits would not be distributed on NPS units in PA, NJ, and
WV. The no action alternative would most likely result in greater risk
of human exposure to rabies than the proposed action because the
involved state ORVAC programs would have less chance of being successful
in stopping or preventing the spread of the raccoon rabies variant.

**Potential for Vaccinia Virus to Cause Disease in Humans**

This risk would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

**Potential to Cause Cancer (Oncogenicity)**

This risk would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} Cumulative impacts of the No Action
alternative could result in an increase in human exposure to the raccoon
variant of the rabies virus. Reservoirs of the virus could remain in
untreated areas making the total elimination of this strain of the virus
highly unlikely. This alternative could result in moderate, adverse
cumulative impacts to humans. No cumulative impacts from the
distribution of ORVAC into the environment would occur since no ORVAC
baits would be used.

[Conclusion:]{.underline} There would be no direct impact to humans as
ORVAC baits would not be distributed and humans would, therefore, not be
exposed the vaccine or baits. However, there could be an indirect
adverse cumulative impact from increased human exposure to the raccoon
variant of the rabies virus. This alternative would not support the
efforts of the states of PA, NJ, and WV in reducing or eliminating this
strain of the virus from the eastern U.S.

**5.2** **Effects of the ORVAC V-RG Vaccine on Raccoons**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

The primary concern here is whether the V-RG virus may cause disease in
raccoons that consume ORVAC baits. Large numbers of raccoons have been
inoculated with, or have consumed baits containing, the vaccine without
ill effects, and most were successfully immunized against rabies (USDA
1991, p. 25; Rupprecht et al.1986). Tests showed that the V-RG virus did
not invade the CNS or the cerebrospinal fluid of treated raccoons which
indicated no adverse effects on the CNS is likely (USDA 1991, p. 25;
Hanlon et al. 1989b). Other tests showed that the V-RG vaccine did not
cause any lesions or viremia (i.e., presence of the virus in the blood)
in tissues sampled from treated raccoons (Rupprecht et al. 1988). These
studies, in addition to the absence of reports of adverse effects in
free-ranging wildlife in current/historical ORVAC program areas, have
demonstrated the safety and effectiveness of the V-RG vaccine in
raccoons. ORVAC baits containing the V-RG vaccine would thus have no
adverse impact on raccoon populations.

[Cumulative Impacts:]{.underline} Cumulative impacts would likely be
beneficial as the proposed ORVAC program would reduce the possibility of
raccoons becoming infected with the rabies virus. The ORVAC vaccine and
bait that would be used has been found safe to use on raccoons. The
ORVAC vaccine and bait that would be used has a negligible risk of
causing adverse affects to raccoons. Cumulative impacts to raccoons
would likely be beneficial as those raccoons that consume baits would
likely be vaccinated against the rabies virus.

[Conclusion:]{.underline} Adverse impacts to raccoons from contact with
the V-RG vaccine are believed to be negligible. Implementation of an
ORVAC program would likely have a beneficial impact to raccoons by
reducing the occurrence of the raccoon variant of the rabies virus in
the wild. This alternative would support the states of PA, NJ, and WV in
the effort of reducing or possibly eliminating of this strain of the
virus from the eastern U.S.

Because the actions described in the alternative would not severely
affect a resource or value whose conservation is (1) necessary to
fulfill specific purposes identified in the establishing legislation or
proclamation of the units; (2) key to the natural or cultural integrity
of the units or to opportunities for enjoyment of the units; or (3)
identified as a goal in the units' general management plan or other
relevant National Park Service planning documents, there would be no
impairment of the parks' resources or values.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

The potential effects of raccoons being exposed to the V-RG vaccine
would not occur since ORVAC baits would not be distributed on NPS units
in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} Cumulative impacts of the No Action
alternative could result in an increase in raccoon exposure to the
rabies virus. Reservoirs of the virus could remain in untreated areas
making the total elimination of this strain of the virus highly
unlikely. This alternative could result in moderate, adverse cumulative
impacts to raccoons. No cumulative impacts from the distribution of
ORVAC into the environment would occur since no ORVAC baits would be
used.

[Conclusion:]{.underline} There would be no direct impact to raccoons as
ORVAC baits would not be distributed and raccoons would, therefore, not
be exposed to the vaccine or baits. However, there could be an indirect
moderate adverse cumulative impact from increased animal exposure to the
raccoon variant of the rabies virus. This alternative would not support
the efforts of the states of PA, NJ, and WV in reducing or eliminating
this strain of the virus from the eastern U.S.

**5.3 Potential for Adverse Effects on Nontarget Wildlife Species,
including Threatened or Endangered Species**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

The primary concern here is whether the vaccinia virus-rabies
glycoprotein combination (i.e., RABORAL V-RG® vaccine) might cause
disease in nontarget animals that consume or otherwise come into contact
with the vaccine. Rupprecht et al. (1992a) and Pastoret et al. (1995)
summarized the results of V-RG safety trials in nontarget species. More
than 50 species from Europe and North America have been tested and
include relevant taxonomic groups believed to be potentially at risk for
contact with the V-RG vaccine such as:

-   Natural ecological competitors of foxes, such as raccoons (*Procyon
    lotor*), opossum (*Didelphis virginianus*), several mustelids
    \[skunk, badger (*Taxidea taxus*), mink (*Mustela vision*), otter
    (*Lutra canadensis*), ferret (*Mustela putorius*)\], other members
    of the Canid family \[coyote, red fox, gray fox, arctic fox (*Alopex
    lagopus*), raccoon dog (*Nyctereutes procyonoides*)\], bobcat (*Lynx
    rufus*), and black bear (*Ursus americanus*).

-   Domestic cats (*Felix domesticus*) and dogs (*Canis familiaris*).

-   19 rodent species (Order *Rodentia*) that might be expected to gnaw
    on or consume baits. Families within this order represented in the
    studies included: *Muridae, Erethizonidae* \[porcupine (*Erithizon*
    *dorsatum*)\], *Sciuridae, Cricetidae,* and *Zapodidae*.

-   1 bat species \[Daubenton's bat (*Myotis daubentoni*)\].

-   8 bird species, including three hawk species \[red-tailed hawk
    (*Buteo jamaicensis*), kestrel (*Falco tinnunculus*), common buzzard
    (*B. Buteo*)\], and one species each of owl \[great horned owl
    (*Bubo virginianus*)\], crow \[carrion crow (*Corvus corone*)\],
    gull \[ring-billed gull (*Larus delawarensis*)\], magpie (*Pica
    pica*), and jay (*Garrulus glandarius*).

-   Domestic livestock \[cattle (*Bos taurus*), sheep (*Ovis ovis*)\].

-   Two wild ungulate species \[wild boar (*Sus scrofa*) and
    white-tailed deer (*Odocoileus virginianus*)\].

-   Two primate species (squirrel monkey and chimpanzee).

Rupprecht et al. (1992a) reported there has been no mortality or
morbidity (i.e., signs or symptoms of disease) and no lesions typical of
pox virus infections caused by V-RG vaccine in over 350 individual
animals representing some 20 taxonomic families of animals. They
concluded that the extensive laboratory safety experiments showed V-RG
to be safe in all species tested to date. In field trials with V-RG
ORVAC baits to treat wild raccoons in which target and nontarget species
were captured and tested, no vaccine-related lesions or other adverse
effects have been found to occur (Rupprecht et al. 1992a). The ORVAC
program would reduce the likelihood of wildlife being exposed to the
rabies virus.

There is no evidence of potential harm to target or nontarget species
from overdosage of RABORAL V-RG® vaccine by any route or from multiple
doses. A number of nontarget species have been dosed with 2 to 10 times
the amount of vaccine in an individual ORVAC bait without adverse
effects (USDA 1991, p. 47; Rupprecht et al. 1992a). Therefore, even if
domestic animals received multiple doses of vaccine by consuming
multiple baits, no adverse effects would be expected to occur.

The RABORAL V-RG® vaccine would not adversely affect any non-warm
blooded animal species. The vaccinia virus and other orthopoxviruses do
not replicate or reproduce themselves in non-warm blooded species (C.
Rupprecht, CDC, pers. comm. 2002). Therefore, ORVAC is not expected to
cause any adverse effects on fish, reptiles, amphibians, or any
invertebrate species should any members of these groups consume or
otherwise be exposed to the vaccine.

With regard to threatened or endangered species, the RABORAL V-RG®
vaccine distributed in baits would have no adverse effects on any
federal- or state-listed threatened or endangered species or their
critical habitats (see Appendix C and D for species lists). Several
federal- and state-listed carnivore species (listed below) occur within
the states listed under the proposed action (PA, NJ, and WV). These
species may be attracted to ORVAC baits. If these carnivore species came
in contact with and consumed an ORVAC bait it would be expected that
they would experience no effect other than possibly becoming immunized
against rabies.

**Federally Listed T&E Species (USDI 2004b):**

-   **Canada Lynx** (*Lynx canadensis*). This species is shown to
    potentially occur in portions of New York, Pennsylvania, New
    Hampshire, Maine, and Vermont. The USFWS has documentation that lynx
    occur and are reproducing in Maine and therefore believes that lynx
    could possibly disperse to contiguous suitable habitat in New
    Hampshire, but consider lynx occurrence as rare in New Hampshire
    based on recent records (USDI 2000a). Furthermore, the USFWS
    considers it possible that lynx have been extirpated from New
    Hampshire, Vermont and New York (USDI 2000a). The USFWS has
    concluded that, in the Northeast, a population of lynx most likely
    continues to exist in the core region of western Maine, northern New
    Hampshire, southeastern Quebec, and western New Brunswick; however,
    the range appears to have retracted northward (USDI 2000a). Lynx are
    not expected to be attracted to or to consume ORVAC baits and would
    thus not be affected by them. Therefore, APHIS-WS has determined
    that the proposed action would have no effect on this species. A
    potential beneficial indirect impact of ORVAC programs on lynx
    conservation would be a reduced risk of contracting and dying of
    rabies if the spread of raccoon rabies is successfully halted or if
    the variant strain is eliminated.

-   **Gray Wolf** (*Canis lupus*). **Eastern Distinct Population Segment
    (DPS) of the Gray Wolf.** On April 1, 2003 this segment of the gray
    wolf population was reclassified as threatened (previously
    considered endangered under the ESA). The Eastern gray wolf DPS
    encompasses the historical range of the gray wolf from the Great
    Plains to the Atlantic Coast. Due to the successful gray wolf
    recovery in Minnesota, Wisconsin, and Michigan, this DPS is now
    classified as Threatened. This species may be attracted to or
    consume ORVAC baits; however, the only effect of the baits on this
    species would be possible vaccination from rabies. A potential
    beneficial indirect impact of ORVAC programs would be a reduced risk
    of contracting and dying of rabies if the spread of raccoon rabies
    is successfully halted or if the raccoon variant strain is
    eliminated.

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-   **Eastern Puma** (*Puma concolor couguar*). This species is
    designated as endangered in its entire historical range
    (Connecticut, District of Columbia, Delaware, Illinois, Indiana,
    Kentucky, Massachusetts, Maryland, Maine, Michigan, North Carolina,
    Georgia, New Hampshire, New Jersey, New York, Ohio, Pennsylvania,
    Rhode Island, South Carolina, Tennessee, Virginia, Vermont, and West
    Virginia). The Eastern puma is presumed extinct in the wild;
    however, some unconfirmed sightings have been reported in Minnesota
    and Michigan recently (http://endangered.fws.gov/). The USFWS and
    USFS jointly completed a 5-year survey in an attempt to determine
    the presence of self-sustaining cougar populations in the southern
    Appalachian Mountains from Virginia to Northern Georgia. No concrete
    evidence was ever obtained for the existence of eastern cougar
    populations (per <http://endangered.fws.gov/>). This species is not
    expected to be attracted to or to consume ORVAC baits. Therefore,
    ORVAC programs would have no effect on this species. A potential
    beneficial indirect impact of ORVAC programs on this species would
    be a reduced risk of contracting and dying of rabies if the spread
    of raccoon rabies is successfully halted or if the variant strain is
    eliminated.

-   **West Virginia Northern Flying Squirrel** (*Glaucomys sabrinus
    fuscus*). This species is federally-listed as endangered in West
    Virginia. It is conceivable that this species could consume ORVAC
    baits intended for raccoons. Although not specifically tested for
    safety in this species, safety studies on other closely related
    rodent species (Rupprecht et al. 1992a) indicate flying squirrels
    would not be adversely affected. Also, an indirect beneficial effect
    would be a reduced risk of the species suffering further declines
    because of a rabies epizootic. Therefore, the proposed action should
    have no adverse impact on this species.

**State listed species:**

-   **Delmarva Fox Squirrel** (*Sciurus niger cinereus*). This species
    is state-listed as endangered in Pennsylvania. Although a few
    sightings of the Delmarva fox squirrel have been reported in the
    extreme southeast corner of the state, the Pennsylvania Game
    Commission has not documented these reports. It is conceivable that
    this species could consume ORVAC baits intended for raccoons.
    Although not specifically tested for safety in this species, safety
    studies on other closely related rodent species (Rupprecht et al.
    1992a) indicate fox squirrels would not be adversely affected. Also,
    an indirect beneficial effect would be a reduced risk of the species
    suffering further declines because of a rabies epizootic. Therefore,
    the proposed action should have no adverse impact on this species.

-   **West Virginia Northern Flying Squirrel** (*Glaucomys sabrinus
    fuscus*). The West Virginia northern flying squirrel is state-listed
    as a "species of concern" in West Virginia. Although not
    specifically tested for safety in this species, safety studies on
    other closely related rodent species (Rupprecht et al. 1992a)
    indicate flying squirrels would not be adversely affected if they
    were to consume ORVAC baits. Also, an indirect beneficial effect
    would be a reduced risk of the species suffering further declines
    because of a rabies epizootic. Therefore, the proposed action should
    have no significant impact on this species.

-   **Eastern Spotted Skunk** (*Spilogale putorius*). This species is
    state-listed as a "species of concern" in West Virginia. It is
    conceivable that this species could consume ORVAC baits intended for
    raccoons. Safety studies on skunks (Rupprecht et al. 1992a) indicate
    this species would not be adversely affected if they were to consume
    ORVAC baits. Also, an indirect beneficial effect would be a reduced
    risk of the species suffering further declines because of a rabies
    epizootic. Therefore, the proposed action should have no significant
    impact on this species.

-   **Appalachian Cottontail** (*Sylvilagus obscurus*). This species is
    state-listed as a "species of concern" in West Virginia. Cottontails
    would not likely be attracted to or consume ORVAC baits. Therefore,
    ORVAC should have no effect on this species. Also, an indirect
    beneficial effect would be a reduced risk of this species suffering
    further declines in the state because of a rabies epizootic.
    Therefore, the proposed action should have no significant impact on
    this species.

The proposed action would have no effect on any of the other listed
species in the three states involved in the proposed action (see
Appendices C and D).

The USFWS -- Division of Migratory Birds in Hadley, MA (NE Regional
Office) reviewed the proposed ORVAC program and determined the program
would have no negative impacts to migratory birds.

The USFWS Ecological Services offices in each of the states listed under
the proposed action and the USFWS NE Regional Office have reviewed the
proposed ORVAC program and have concurred that the proposed program is
not likely to adversely affect any T&E species or their critical
habitats. However, the USFWS NJ Field Office supervisor stated in
informal consultation that aerial overflights may adversely affect the
federally listed (threatened) bald eagle on or adjacent to the Delaware
Water Gap National Recreation Area -- NJ if activities are conducted
during the nesting season. The USFWS stated that even single passes of
low-flying aircraft can cause abandonment of eagle nests or injury to
flightless young. To ensure that nesting bald eagles are not adversely
affected by low-flying aircraft, the USFWS recommends that flights
maintain a minimum vertical distance of 1,500 feet above ground level in
the vicinity of the nest sites or at least 1 mile lateral distance from
the nest sites. If aerial distribution of baits occurs during the
nesting season, the USFWS requests bait disbursal activities be
coordinated with the USFWS NJ Field Office 30 days prior to bait
distribution to obtain a current list of eagle nest locations that may
be affected by use of low-flying aircraft. The USFWS believes ground
distribution of baits during the bald eagle nesting period or aerial
distribution of baits outside the nesting season are unlikely to
adversely affect nesting eagles.

Precautions would be taken to avoid disturbance of known sites
containing nesting bald eagles. However, no evidence has been found to
indicate harm to eagles or other raptors as the result of an annual
overflight. ORVAC flights would not be chronic, but would only occur
momentarily over any one site and only once per year. Thus, any direct
disturbances would only be momentary in nature and would not be
numerous. In addition, the annual overflight is even less likely to
adversely impact migratory birds if/when flights occur in the fall after
the birds have dispersed. Therefore, impacts from ORVAC bait
distribution overflights should be negligible.

The involved state (PA, NJ, and WV) wildlife agencies have reviewed the
proposed ORVAC program and have indicated that the proposed program
would have no anticipated negative impacts to rare or natural
communities or state-listed wildlife species.

[Cumulative Impacts:]{.underline} There would be no adverse cumulative
impacts of the proposed ORVAC program on nontarget wildlife species,
including any state or federally listed threatened or endangered
species. The ORVAC vaccine and bait that would be used has a negligible
risk of causing adverse affects to nontarget wildlife species.
Cumulative impacts to nontarget wildlife could possibly be beneficial as
those species that consume baits may become vaccinated against the
rabies virus. Additionally, the proposed program would reduce the
likelihood of nontarget wildlife coming into contact with an animal
infected with the rabies virus.

[Conclusion:]{.underline} The RABORAL V-RG® vaccine distributed in baits
would have no adverse effects on nontarget wildlife species, including
any state or federally listed threatened or endangered species.
Implementation of an ORVAC program would likely have a minor beneficial
impact by possibly immunizing other wildlife species against the raccoon
variant of rabies and by reducing the likelihood of becoming exposed to
an animal infected with the rabies virus. This alternative would support
the states of PA, NJ, and WV in the effort of reducing or possibly
eliminating of this strain of the virus from the eastern U.S.

Because the actions described in the alternative would not severely
affect a resource or value whose conservation is (1) necessary to
fulfill specific purposes identified in the establishing legislation or
proclamation of the units; (2) key to the natural or cultural integrity
of the units or to opportunities for enjoyment of the units; or (3)
identified as a goal in the units' general management plan or other
relevant National Park Service planning documents, there would be no
impairment of the parks' resources or values.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

The risk of a nontarget wildlife species being exposed to the V-RG
vaccine would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} Cumulative impacts of the No Action
alternative could result in an increase in exposure of nontarget
wildlife to the rabies virus. Reservoirs of the virus could remain in
untreated areas making the total elimination of this strain of the virus
highly unlikely. This alternative could result in minor, adverse
cumulative impacts to other wildlife species. No cumulative impacts from
the distribution of ORVAC into the environment would occur since no
ORVAC baits would be used.

[Conclusion:]{.underline} The risk of a nontarget wildlife species being
exposed to the V-RG vaccine would not occur since ORVAC baits would not
be distributed on NPS units in PA, NJ, and WV. However, failure to stop
or prevent the spread of rabies would result in adverse effects on
wildlife by increasing the likelihood of exposure to an animal infected
with the rabies virus. This alternative would not support the efforts of
the states of PA, NJ, and WV in reducing or eliminating this strain of
the virus from the eastern U.S.

**5.4 Potential for Adverse Effects on Pet Dogs or Other Domestic
Animals that Might Consume the Baits**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

Rupprecht et al. (1992a) and Pastoret et al. (1995) summarized the
results of V-RG safety trials in nontarget species. These studies
included the oral vaccination of domestic dogs, cats, cattle, and sheep
and found no adverse effects on these species. More than 43.75 million
ORVAC baits using the RABORAL V-RG® vaccine have been distributed in the
U.S. during the APHIS-WS program thus far with no reported adverse
effects on domestic animals. There is no evidence of potential harm to
target or nontarget species, including domestic dogs, cats, cattle, and
sheep, from overdosage of RABORAL V-RG® vaccine by any route or from
multiple doses. A number of nontarget species have been dosed with 2 to
10 times the amount of vaccine in an individual ORVAC bait without
adverse effects (USDA 1991, p. 47; Rupprecht et al. 1992a). Therefore,
even if domestic animals received multiple doses of vaccine by consuming
multiple baits, no adverse effects would be expected to occur.

As discussed in section 4.1, a recent study indicates vaccinia virus
that originated from a strain used in smallpox vaccinations in Brazil
may have become established in domestic cows in that country (Damaso et
al. 2000). This indicates there is some potential for use of vaccinia
virus in vaccinations to result in a new emerging infectious disease in
domestic animals; however, there is currently no evidence that this type
of phenomenon has occurred in the U.S. (C. Rupprecht, CDC, pers. comm.
2001 *in* USDA 2001a). Also, the vaccinia virus strain used for smallpox
vaccination in Brazil was different than the strain that is currently
used in the V-RG vaccine. The vaccinia virus portion of V-RG is more
attenuated (i.e., *weaker*) than strains used in smallpox vaccines (USDA
1991, p. 18-19). Thus, it is less likely that V-RG would result in the
establishment and persistence of vaccinia virus in wild animal
populations.

Instances have been reported where a pet dog has consumed several baits
and then vomited the plastic sachets (R. Hale, Ohio Dept. of Health,
pers. comm. 2001). Reports of these types of instances have been few,
and the dogs have reportedly not experienced any substantive or long
term adverse effects. USDA (2004b) documented that of the 43.75 million
baits distributed during the APHIS-WS ORVAC program between 1995 and
2003 only 424 instances have been reported where a pet or other domestic
animal had contact with a bait. This equates to 1 domestic exposure per
103,184 baits disbursed or 0.00096 percent contact cases. No cases of
adverse reaction in pets or other domestic animals have ever been
reported during the APHIS-WS program. In addition, USDA (2004b)
documented that 146 incidents were reported where pets came into contact
with a bait in 2003; however, no reports of pets or other domestic
animals experiencing any type of adverse reaction were submitted.
Domestic animals that bite into and ingest a bait are most likely to be
immunized against rabies or receive a boost from a previous vaccination.
USDA (2004b) also documented the number of baits distributed in those
states conducting ORVAC programs and the number of people who reported
contact or potential contact with a bait by their pet or other domestic
animal (i.e., carrying bait in mouth, chewing bait, vomiting sachet).
The number of documented exposures equates to 0.0014 percent of the
10.26 million baits distributed in 2003 or one domestic animal exposure
per 70,252 baits distributed. The domestic animals reported to have been
exposed to a bait involved 122 dogs, 6 cats, 1 cow, 1 horse, 1 alpaca,
and 15 unknown/unidentified animals. In the monitoring report (USDA
2004b), APHIS-WS concluded that adverse cumulative impacts to pets and
other domestic animals continue to be negligible.

[Cumulative Impacts:]{.underline} There would be no adverse cumulative
impacts of the proposed ORVAC program on pet dogs or other domestic
animals. The ORVAC vaccine and bait that would be used has a negligible
risk of causing adverse affects to these animals. Cumulative impacts to
pets and other domestic animals could possibly be beneficial as those
species that consume baits may become vaccinated against the rabies
virus. Additionally, the proposed program would reduce the likelihood of
pets and other domestic animals coming into contact with an animal
infected with the rabies virus.

[Conclusion:]{.underline} The RABORAL V-RG® vaccine distributed in baits
would have no adverse effects on pets or other domestic animals.
Implementation of an ORVAC program would likely have a moderate
beneficial impact by possibly immunizing these animals against rabies
and reducing the likelihood of becoming exposed to an animal infected
with the rabies virus. This alternative would support the states of PA,
NJ, and WV in the effort of reducing or possibly eliminating of this
strain of the virus from the eastern U.S.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

The risk of a pet dog or domestic animal being exposed to the V-RG
vaccine would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} Cumulative impacts of the No Action
alternative could result in an increase in exposure of pets and other
domestic animals to the rabies virus. Reservoirs of the virus could
remain in untreated areas making the total elimination of this strain of
the virus highly unlikely. This alternative could result in moderate,
adverse cumulative impacts to pets and other domestic animals. No
cumulative impacts from the distribution of ORVAC into the environment
would occur since no ORVAC baits would be used.

[Conclusion:]{.underline} The risk of a pet dog or domestic animal being
exposed to the V-RG vaccine would not occur since ORVAC baits would not
be distributed on NPS units in PA, NJ, and WV. However, failure to stop
or prevent the spread of rabies would result in adverse effects on
domestic animals by increasing the likelihood of exposure to rabid wild
animals. This alternative would not support the efforts of the states of
PA, NJ, and WV in reducing or eliminating this strain of the virus from
the eastern U.S.

**5.5 Potential for the Recombined V-RG Virus to "Revert to Virulence"
and Result in a Virus that Could Cause Disease in Humans or Animals**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

The concern here is whether the V-RG recombinant virus is genetically
stable so that it would not become virulent (i.e., capable of causing
disease) after it replicates (or reproduces) in animals that consume
ORVAC baits containing the RABORAL V-RG® vaccine and, perhaps, be
transmitted on to other animals. This issue was addressed in previous
EAs and in formal risk assessments by USDA, APHIS (USDA 1991, p. 41-42;
USDA *undated a* *and undated b*). The Wistar Institute conducted
experiments with mice in which the V-RG was "subpassaged[^4]" four times
into groups of mice (results cited in USDA 1991, p. 41). The V-RG virus
could not be found after passage through the second or third groups of
mice. These experiments demonstrated that the ability of the V-RG virus
to cause disease does not increase by repeated animal passage, thus
"reversion to virulence" is unlikely. Further alleviating the concern
about this issue is the evidence that V-RG virus does not transmit
readily to other animals from animals that have consumed ORVAC baits
(Rupprecht and Kieny 1988).

[Cumulative Impacts:]{.underline} Adverse cumulative impacts of the
proposed ORVAC program as a result of the potential for the recombined
V-RG virus to "revert to virulence" would be negligible.

[Conclusion:]{.underline} The potential for the recombined V-RG virus to
"revert to virulence" would be negligible. The RABORAL V-RG® vaccine
distributed in baits would have no adverse effects on humans or animals.

Because the actions described in the alternative would not severely
affect a resource or value whose conservation is (1) necessary to
fulfill specific purposes identified in the establishing legislation or
proclamation of the units; (2) key to the natural or cultural integrity
of the units or to opportunities for enjoyment of the units; or (3)
identified as a goal in the units' general management plan or other
relevant National Park Service planning documents, there would be no
impairment of the parks' resources or values.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

This risk would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} No cumulative impacts from the
distribution of ORVAC into the environment would occur since no ORVAC
baits would be used.

[Conclusion:]{.underline} The risk of the recombined V-RG virus
"reverting to virulence" would not occur since ORVAC baits would not be
distributed on NPS units in PA, NJ, and WV.

**5.6 Potential for the RABORAL V-RG® Vaccine to Recombine with Other
Viruses in the Wild to Form New Viruses that Could Cause Disease in
Humans or Animals**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

The concern here is whether the RABORAL V-RG® vaccine in the ORVAC baits
might encounter other viruses in animals, exchange genetic material with
them during replication, and result in new viruses that could cause
serious diseases in humans or animals. This potential recombination has
been recognized as being more probable with wild pox viruses that are
genetically similar to the vaccinia virus used as the vector in the
RABORAL V-RG® vaccine. Wild pox viruses present in the U.S. include
skunk, rodent, and raccoon pox (RP) viruses (C. Rupprecht, CDC, pers.
comm. 2001 *in* USDA 2001a). RP has not been found to be prevalent in
the environment, with only two concurrent isolations (or detections) of
it having occurred in the U.S. (Herman 1964, cited in USDA 1991, p. 42).

For these types of unanticipated spontaneous recombinations to occur,
the V-RG and RP would have to simultaneously infect the same cells in
the same animal at the same time. The Wistar Institute identified three
circumstances that would have to occur simultaneously for there to be a
chance of a hazardous recombination between V-RG and RP virus: (1) they
would have to occur at the same time in the same animal; (2) "genome
contact" (i.e., contact between the actual genetic material in the two
viruses as they replicate in an infected cell); *and* (3) the
regeneration of the gene that was previously removed from the vaccinia
virus (known as the thymidine kinase "TK" gene) (USDA 1991, p. 42).
Wistar determined the probability of all three circumstances occurring
at the same time was 1 chance in 100 million or less (USDA 1991, p. 42).
Also, if this did somehow occur resulting in a recombined virus with the
functional "TK" gene reestablished, the properties and virulence of the
new virus would probably be similar to the original recipient virus
which is vaccinia (USDA *undated b*, p. 28). Vaccinia only causes mild
short-term symptoms in most cases (i.e., similar to the localized rash
and pustules that occurred on the arms of many persons who received
smallpox vaccinations) (USDA 1991, p. 39; Elvinger 2001). Thus,
recombination with wild viruses is unlikely, but, if it did occur, it is
also unlikely to result in significant adverse effects on animals or
people. Laboratory experiments on mice infected with RP and inoculated
with V-RG showed no adverse effects on the mice (USDA, 1991, p. 42).

Combination of two types of pox viruses in rabbits or hares
(leporipoxviruses) has been known to occur (Omlin 1997), but the
combination of a leporipoxvirus with another unrelated pox virus has not
been known to occur (USDA 1991, p. 42). Rare examples of recombination
between different poxviruses in animal hosts have been documented,
although the probability of two viruses infecting the same cell at the
same time (which is required for recombination to occur) under natural
conditions remains very low (Omlin 1997). Recombination of V-RG with
viruses other than orthopoxviruses is not likely (Omlin 1997). In formal
risk analyses, APHIS concluded that the probability of recombination
with other orthopoxviruses would be limited due to the low prevalence of
orthopoxviruses in wildlife species in the U.S. (USDA *undated a and
undated b*).

Hahn (1992) concluded that vaccines developed by the newer genetic
engineering (i.e., recombinant) techniques such as the ones used to make
V-RG vaccine are no more hazardous than vaccines created by more
conventional methods (e.g., "attenuation" and "fractionation"). He
further indicated that, with recombinant technology, the potential for
ending up with a dangerous virulent strain is probably less than with
the older "hit-or-miss" methods, because the specific genetic material
responsible for making a virus virulent can be removed or altered which
makes the virus safer.

[Cumulative Impacts:]{.underline} Adverse cumulative impacts of the
proposed ORVAC program as a result of the potential for the RABORAL V-RG
vaccine to recombine with other viruses to form new viruses that could
cause disease in humans or animals would be negligible.

[Conclusion:]{.underline} This analysis, which incorporates previous
analyses by reference, supports a conclusion that adverse environmental
effects from spontaneous recombination of V-RG with other wild viruses
would be exceedingly unlikely and negligible. This is further supported
by the fact that there have been no observed adverse effects in wildlife
and humans both in Europe and North America following a number of years
of experimental and field use of the V-RG vaccine.

Because the actions described in the alternative would not severely
affect a resource or value whose conservation is (1) necessary to
fulfill specific purposes identified in the establishing legislation or
proclamation of the units; (2) key to the natural or cultural integrity
of the units or to opportunities for enjoyment of the units; or (3)
identified as a goal in the units' general management plan or other
relevant National Park Service planning documents, there would be no
impairment of the parks' resources or values.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

This risk would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} No cumulative impacts from the
distribution of ORVAC into the environment would occur since no ORVAC
baits would be used.

[Conclusion:]{.underline} The risk of the RABORAL V-RG vaccine
recombining with other viruses to form new viruses that could cause
disease in humans or animals would not occur since ORVAC baits would not
be distributed on NPS units in PA, NJ, and WV. []{.mark}

**5.7 Potential for Aerially Dropped Baits to Strike and Injure People
or Domestic Animals**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

Bait density would average 75 per sq km (194 per sq mile) in eastern
states where raccoon rabies is targeted. This density is sparse enough
to predict that the chance of a person being struck and harmed by a
falling bait is extremely remote. For example, if 100 persons were
standing outdoors in a square mile of area in which ORVAC baits were
being dropped, and each person occupies about 2 square feet of space at
the time that baits were dropped, the chance of being struck would be 1
in 139,000 (200 sq ft total space occupied by persons divided by 27.8
million sq ft per sq mi). The negligible risk of being struck is further
supported by the fact that out of more than 43.75 million baits
distributed in the U.S. by APHIS-WS between 1995 and 2003, only 9
incidents have been reported in which a person claimed to have been
struck by a falling bait (0.00002 percent chance of being struck by a
bait or 1 strike per 4.86 million baits dropped) (USDA 2004b). None of
the reports since APHIS-WS' ORVAC program inception have resulted in any
injury or harm to the individuals involved. Eight of these incidents
occurred in Pennsylvania, Texas, Ohio, and Ontario and did not result in
any significant injury or harm to the individuals involved (G. Moore, TX
Dept. of Health, pers. comm. 2001; R. Hale, OH Dept. of Health, pers.
comm. 2001; C. MacInnes, Ontario Ministry of Natural Resources, pers.
comm. 2001).

Of the 10.26 million baits that were distributed by APHIS-WS in 2003, 4
incidents were reported in which a person claimed to have been struck by
a falling bait (1 strike per 2.56 million baits dropped in 2003). All 4
incidents were reported in Pennsylvania where baiting was conducted in
more urbanized areas (1 strike per 427,600 baits disbursed in
Pennsylvania). No reports of injury were received during the 2003
APHIS-WS ORVAC program (USDA 2004b). In 2003, no cases were documented
involving falling baits striking or injuring domestic animals. In 2003,
reports were received regarding baits striking property. The reports
involved 3 trucks, 1 car, 1 sunroof, and 3 swimming pools in
Pennsylvania; 1 swimming pool in West Virginia; and 1 house in Georgia
(reported to the Alabama Health department) (USDA 2004b). The potential
for falling baits to strike or injure people or domestic animals
continues to be insignificant. Impacts of the program on this issue are
expected to remain negligible. The potential for baits to strike people
or animals is further mitigated by the fact that bait disbursal crews
avoid dropping baits into cities, towns, and other areas with human
dwellings, or if humans are observed below. Hand placement or dropping
of baits from slower moving helicopters to allow for more precise
control over the areas on which the baits are dropped would primarily be
used in urban parks or suburban situations, which would further reduce
the risk of being struck. Additionally, in areas where backcountry
campgrounds are difficult to discern from the air, bait drops would be
coordinated to alert campers of the situation or would be conducted when
hiking/camping densities are low.

[Cumulative Impacts:]{.underline} Adverse cumulative impacts of the
proposed ORVAC program as a result of the potential for aerially dropped
baits to strike and injure people or domestic animals would be
negligible.

[Conclusion:]{.underline} The chance of a person or animal being struck
and harmed by a falling bait would be extremely remote. To further
mitigate the possibility of striking people or animals, bait drop crews
would avoid areas containing human dwellings.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

This risk would not occur since ORVAC baits would not be distributed on
NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} No cumulative impacts from the
distribution of ORVAC into the environment would occur since no ORVAC
baits would be used.

[Conclusion:]{.underline} There would be no risk of aerially dropped
baits striking and injuring people or domestic animals since ORVAC baits
would not be distributed on NPS units in PA, NJ, and WV. []{.mark}

**5.8 Potential Impacts on Visitor Use/Experience**

**Alternative 1 - Authorize an ORVAC Program (Proposed Action)**

Many people visit NPS lands each year to escape the sounds and sights of
everyday life. Others visit these areas to experience nature in its
"natural" state or just to experience the serenity that a NPS park can
provide. These people are concerned that the ORVAC program may adversely
affect a person's outdoor experience when visiting NPS units in PA, NJ,
and WV.

**Impacts of Aerial Distribution of ORVAC Baits**

Some people have expressed that overflights of aircraft involved in the
distribution of ORVAC baits may adversely impact visitor use and overall
park experience. The natural quiet is an important natural resource of
the NPS (USDI 1995). The ORVAC program recognizes this concern and
attempts to limit a person's exposure to bait distributing aircraft.

Effects on park visitors can be highly variable depending upon the park
activities utilized by the visitor (USDI 1995). Backcountry visitors
(people using remote areas of the park that are inaccessible by
vehicles) would likely be affected to a greater extent than frontcountry
visitors (people using areas that are accessible to vehicles).

In general, it appears that the more serious potential impacts occur
when overflights are *chronic*, i.e., they occur daily or more often
over long periods of time. Chronic exposure situations generally involve
areas near commercial airports and military flight training facilities.
ORVAC program aerial bait distribution activities are not chronic, but
only occur once per year. They are typically conducted during the spring
and/or fall months (February 1-May 31 and/or August 15 to November 30);
at about 500 feet above ground level; and only fly momentarily over any
one point on the ground during any given bait distribution flight. The
aircraft do not circle over areas repeatedly, but fly in straight
"transect" lines for purposes of bait distribution. There is a
possibility that a visitor may be exposed to a brief encounter with an
aircraft distributing baits but not to the extent that a person would be
exposed repeatedly or for an extended period of time.

Due to the limited amount of exposure to bait distributing aircraft, it
is highly unlikely that a person's park experience would be seriously
impacted by this action.

**Impacts of Finding an ORVAC Bait or Vaccine Sachet**

People visiting NPS units in PA, NJ, and WV are concerned that their
park experience may be lessened as a result of finding an unconsumed
bait or empty sachet. The likelihood of this occurring is extremely low
due to the limited number of baits that are dropped in a specific area,
the biodegradability of the vaccine liquid and baits, and the high
consumption rate of ORVAC baits by animal species.

The possibility of a person coming in contact with an ORVAC bait is
extremely low due to the bait distribution densities used by the
program. Under the proposed program, ORVAC baits would be distributed
once a year at an average density of 75 per square km. Furthermore,
McGuill et al. (1998) conducted a retrospective 4-year survey of
directors of 6 ORVAC programs using V-RG vaccine from 1992-1996. The
programs occurred in Florida (2), Massachusetts (6), New Jersey (6), New
York (7), and Texas (2). Altogether, they involved a total of 42,181 sq
miles of treated area and a total of nearly 6 million baits distributed.
Human contacts with the baits totaled 316.

The baits used for the raccoon ORVAC program are small blocks of
fishmeal that are held together with a polymer binding agent and are
considered to be "food grade" materials. Therefore, the unconsumed bait
material would quickly biodegrade when exposed to the environment.

The ORVAC baits are readily taken up and consumed by wildlife species
thereby reducing the possibility of a person coming into contact with an
ORVAC bait. The likelihood of a bait being consumed is dependent upon
several factors including animal densities (target and nontarget
species), bait preference, and the availability of alternative food
sources. In field tests conducted in the U.S., the majority of ORVAC
baits have been consumed within the first 7 to 14 days after placement,
with reports of up to 100 percent of the baits being consumed within a 7
day period (Farry et al. 1998a and 1998b, Hable et al. 1992, Hadidian et
al. 1989, Hanlon et al. 1989a, Linhart et al. 1994, Steelman et al.
2000, USDA 1995a).

There is a remote possibility that a park visitor may encounter a sachet
since they are not readily digested by animals that consume ORVAC baits.
This type of occurrence is expected to be minimal. Out of approximately
43.75 million baits disbursed since APHIS-WS program inception in 1995,
only 576 people reported contacting or potentially contacting a bait
(i.e., picking up bait, finding a bait in yard, or removing bait or
sachet from pet's mouth, feces, or vomit - any type of contact with a
bait is also defined throughout the document as an "exposure"). This
equates to one human exposure per 75,955 baits distributed (0.0013
percent contact cases). In addition, exposure cases were generally
insignificant as most involved finding an intact bait. Very few cases
involved touching a broken bait, sachet, or liquid vaccine. Most people
were exposed to baits as a result of a pet finding the bait and bringing
it home. Therefore, the possibility of a park visitor encountering a
bait would likely be even lower on NPS units.

**Risk of Being Exposed to a Rabid Animal**

Since the first field release of the V-RG vaccine in 1990, the number of
vaccine-laden baits that were distributed annually in the U.S. has risen
exponentially. For instance, APHIS-WS' involvement in the national
rabies management program between 1995 and 2003 contributed to 43.75
million ORVAC baits disbursed in the U.S (USDA 2004c). Numerous projects
have been conducted or are in progress in the eastern U.S. and Texas
(USDA 2004a, 2004c). Since ORVAC program inception, positive rabies
cases have either decreased or the advance of the virus has been slowed
or stopped in each state where an ORVAC program was initiated:

-   In Maryland, 18 rabies cases were reported per year on the Annapolis
    Peninsula alone before the ORVAC program began in 1998. From
    2000-2002 and 2003, Maryland reported zero cases and one case,
    respectively (USDA 2004a, 2004c).

-   In New York, an ORVAC program was implemented in 1998 to prevent the
    northward spread of the virus. Prior to the ORVAC program in New
    York, almost 150 positive rabies cases were recorded in 1998
    and 1999. In 2002, New York reported a decline to 4 positive rabies
    cases, of which only one was attributed to a raccoon, and zero cases
    have been reported since (USDA 2004a, 2004c). A recently completed
    project in Albany and Rensselaer Counties of New York State
    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 ORVAC.

> In late August, 2004, APHIS-WS initiated a cooperative emergency
> rabies surveillance and control program on Long Island (Nassau County)
> in cooperation with the New York State Department of Health (NYSDOH),
> Agriculture and Markets, Department of Environmental Conservation and
> the Nassau County Department of Health. The program included enhanced
> surveillance to better document the location and scope of a recent
> rabies outbreak and vaccination of raccoons to prevent the further
> spread of rabies. As a result of enhanced surveillance efforts, seven
> raccoons were confirmed to have the raccoon strain of rabies in Nassau
> County. More than 350 raccoons were trapped and submitted for testing
> within a 2 mile radius of the index case. This is the first time
> raccoon rabies has been documented on Long Island. Two types of
> vaccination programs were implemented in September, 2004 on Long
> Island by APHIS-WS and NYSDOH, including raccoon
> trap-vaccinate-release (more than 400 raccoons vaccinated) and ORVAC
> programs where 11,000 coated sachet baits were distributed by New York
> State police helicopters and 10,000 fishmeal polymer baits were
> distributed by hand in a zone around the positive cases. The
> contingency effort on Long Island focused on creating a rabies-immune
> raccoon population in the target zone to prevent additional cases.
> High densities of raccoons on Long Island make it more likely for a
> human, pet, or other domestic animal to encounter a rabid raccoon;
> thus the spread of raccoon rabies is of great concern. Enhanced
> surveillance and vaccination of raccoons will greatly decrease the
> chance of human and domestic animal contact with rabid raccoons (R.
> Chipman, APHIS-WS, pers. comm. 2004).

-   In Vermont, before the program was started in 1996, positive rabies
    cases were found 73 km. (45.5 miles) south of the Quebec, Canada
    border. With an annual rate of spread of rabies at 56.3 km/year (35
    miles/year), positive raccoon strain rabies cases should have
    reached the Canada border as early as 1999. However, the border has
    not yet been breached (USDA 2004a, 2004c). Annual vaccination
    projects in the Lake Champlain Valley in Vermont and New York have
    shown promise in preventing the northward spread of raccoon rabies.
    Raccoon rabies has moved through much of the St. Lawrence River
    Valley in northern New York with the appearance of two raccoon
    rabies foci (i.e., point locations of rabies cases) in southern
    Ontario. Cooperative efforts with Ontario and the implementation of
    point infection control strategies in Ontario around these foci are
    under evaluation to determine if the raccoon variant of the rabies
    virus can be contained and eliminated (L. Bigler, pers. comm. 2001).

-   In Ohio, 62 positive rabies cases were recorded prior to program
    implementation in 1997. From 2001-2003, three cases were reported
    near the Pennsylvania border where raccoon rabies is still enzootic.
    In 2001, APHIS-WS, in coordination with state agencies, began an
    ORVAC program in Pennsylvania (USDA 2004a, 2004c) to address this
    issue. The ability to create rabies-free zones, within raccoon
    rabies enzootic areas, is a requisite to achieve elimination of this
    variant of the rabies virus.

> In mid-July 2004, a raccoon infected with raccoon variant of the
> rabies virus was confirmed just west of the ORVAC zone near Lake Erie
> in Lake County in northeastern Ohio. This cooperative ORVAC project
> began in 1997 and has expanded to include the states of Pennsylvania,
> West Virginia, Virginia, Tennessee, Maryland, Georgia and Alabama.
> Throughout its length from Ohio to northeastern Alabama, the ORVAC
> zone is at least 30-miles in width to attempt to prevent the westward
> spread of raccoon rabies. APHIS-WS and state, county and municipal
> cooperators responded immediately to this high priority rabies issue.
> A contingency action plan that included enhanced rabies surveillance,
> trap-vaccinate-release, and ORVAC was implemented upon detection of
> the index case. High raccoon population densities and additional
> rabies cases based on enhanced surveillance suggest that additional
> action may be required. Enhanced rabies surveillance is being
> maintained on the south and west sides of this outbreak to determine
> the next course of action, if required.

-   In Massachusetts, the rabies virus had not spread to Cape Cod where
    intensive baiting programs at the peninsular neck (since 1995),
    combined with the natural barrier of Cape Cod Canal, seemed to act
    as effective barriers (Robbins et al. 1998). In early March 2004,
    however, raccoon variant of the rabies virus was confirmed east of
    the Cape Cod Canal for the first time. The canal served as the
    eastern anchor point for the ORVAC zone which was designed to
    prevent raccoon rabies from spreading east onto the Cape. This
    cooperative project was initiated in the mid-1990s by Tufts
    University and the State of Massachusetts Health Department.
    APHIS-WS became a partner in this effort in 2001. APHIS-WS, Tufts
    University, and the State of Massachusetts Health Department
    immediately implemented enhanced rabies surveillance, followed by
    trap-vaccinate-release, and ORVAC as a contingency action plan to
    prevent further spread, with the long range goal of eliminating
    raccoon rabies from the area. It is not known if raccoon rabies
    spread to the Cape through the long range movement of an individual
    rabid raccoon, or skunk infected with raccoon variant of the rabies
    virus, or if the virus spread animal to animal approaching the
    canal, with rabies spreading to the Cape through a short range
    raccoon or skunk movement across the canal. Translocation, either
    intentional or unintentional (i.e., raccoon "hitch-hiking" in a
    garbage truck or tailored boat and escaping once on the Cape),
    represents another other potential source of spread.

-   In June 2003, the rabies front, which had stalled in North Carolina,
    finally moved west and crossed over the Appalachians into upper east
    Tennessee (6 raccoon strain cases were reported). In attempt to stay
    ahead of the rabies front, APHIS-WS extended the ORVAC baiting area
    into Tennessee (USDA 2004a, 2004c).

-   Since 1995, 9.35 million vaccine-laden baits have been distributed
    in south Texas in an ORVAC program that has proved to be highly
    effective in the elimination of the coyote rabies strain in that
    area. Prior to the ORVAC program, 166 canine strain rabies cases
    were reported in Texas. One case was reported in 2001 along the
    Texas-Mexico border and zero cases have been reported since. Similar
    success is sought in the gray fox epizootic in west-central Texas
    where 10.6 million vaccine-laden baits have been distributed. In
    2002, 18 positive cases of gray fox strain rabies occurred outside
    the barrier, possibly due to an interrupted baiting program in 2000
    and 2001 as a result of a lack of funding. Increased funding was
    provided for the 2003 gray fox ORVAC program in Texas in order to
    encircle the zone where positive cases have been reported and
    blanket the area (USDA 2004a, 2004c).

These data clearly demonstrate that the ORVAC program has been effective
at stopping the forward advance of various rabies strains and in
reducing the incidence of rabies cases involving wild and domestic
animals and rabies exposures to humans. A similar response to the
program can be expected to occur at NPS units in PA, NJ, and WV.

[Cumulative Impacts:]{.underline} The ORVAC vaccine and bait that would
be used has a negligible risk of causing adverse affects to humans. A
limited number of baits would be distributed one time per year on an
annual basis, thereby limiting the amount of exposure a person may have
to an ORVAC bait or bait distributing equipment (i.e., aircraft).
Cumulative impacts to humans would likely be beneficial as the proposed
ORVAC program would reduce the risk of humans encountering a rabid
animal. Any adverse impacts to humans from exposure to the vaccine or
baits would be negligible.

[Conclusion:]{.underline} The ORVAC program should have no adverse
effects on visitor use/experience (i.e., noise from bait distributing
aircraft, finding a bait or sachet, and encountering a rabid animal) at
NPS units in PA, NJ, and WV. Due to the limited amount of exposure to a
bait distributing aircraft, it would be highly unlikely that a person's
park experience would be seriously impacted by this action. Although
there would be a remote possibility that a park visitor may encounter a
sachet since they are not readily digested by animals that consume ORVAC
baits, the potential would be negligible. The risk of a park visitor
being exposed to a rabid animal would be greatly reduced under this
alternative.

**Alternative 2 - No Action** **(No Involvement in Rabies Prevention or
Control)**

**Impacts of Aerial Distribution of ORVAC Baits**

The potential impacts of aerial distribution of baits would not occur
since ORVAC baits would not be distributed on NPS units in PA, NJ, and
WV.

**Impacts of Finding an ORVAC Bait or Vaccine Sachet**

The potential impacts of finding an ORVAC bait or sachet would not occur
since ORVAC baits would not be distributed on NPS units in PA, NJ, and
WV.

**Risk of Being Exposed to a Rabid Animal**

The risk of a park visitor being exposed to a rabid animal would not be
reduced under this alternative. This potential risk could adversely
impact a person's park experience if the visitor is concerned with being
exposed to or coming in contact with a rabid animal.

[Cumulative Impacts:]{.underline} Cumulative impacts of the No Action
alternative could result in an increase in human exposure to a rabid
animal since animals would not receive vaccination by ORVAC bait
distribution. This alternative could result in moderate, adverse
cumulative impacts to humans. No other cumulative impacts on visitor
use/experience, such as impacts of aerial distribution of ORVAC baits or
impacts of finding an ORVAC bait or vaccine sachet, would occur since no
ORVAC baits would be used.

[Conclusion:]{.underline} The potential impacts of aerial distribution
of baits and finding an ORVAC bait or sachet would not occur since ORVAC
baits would not be distributed on NPS lands. However, the risk of a park
visitor being exposed to a rabid animal would not be reduced under this
alternative since ORVAC baits would not be distributed on NPS lands.
This alternative could result in moderate, adverse cumulative impacts to
humans.

[^1]: A disease present among animals in a particular region or
    locality.

[^2]: A thin plastic packet much like those in which condiments (e.g.,
    catsup, mustard) are provided at fast food restaurants.

[^3]: pH is the measure of acidity or alkalinity of a solution with
    numbers below 7 representing a progressively more acidic solution. A
    pH of 3 is highly acidic.

[^4]: This means the V-RG was inoculated into one group of mice from
    which material containing the virus was obtained later and injected
    into a second group of mice, and then material obtained from the
    second group was injected into a third group, etc., until four such
    passages had been conducted.