SUPPLEMENT TO THE ENVIRONMENTAL ASSESSMENT:

FIELD TRIAL OF AN EXPERIMENTAL RABIES VACCINE, HUMAN ADENOVIRUS TYPE 5 

VECTOR IN NEW HAMPSHIRE, NEW YORK, OHIO, VERMONT, AND WEST VIRGINIA

United States Department of Agriculture

Animal and Plant Health Inspection Service

Wildlife Services

In cooperation with:

United States Department of Agriculture

Forest Service

April 2013
I. INTRODUCTION

In 2012, the United States Department of Agriculture (USDA), Animal and Plant Health Inspection 

Service (APHIS), Wildlife Services (WS) program prepared an environmental assessment (EA) to 

evaluate the potential impacts to the quality of the human environment from the implementation of a field

trial to determine the safety and immunogenicity of the human adenovirus type 5-rabies glycoprotein 

(AdRG1.3) (trade name ONRAB; Artemis Technologies Inc., Guelph, Ontario, Canada) rabies vaccine in 

New Hampshire, New York, Ohio, Vermont, and West Virginia (USDA 2012). The EA evaluates the 

need for Oral Rabies Vaccination (ORV) field trials and the relative effectiveness of three alternatives to 

meet that need, while accounting for the potential environmental effects of those activities. 

Comments from the 2012 EA public involvement process were reviewed for substantive issues and 

alternatives and were considered during the development of the Decision for the EA. After consideration 

of the analysis contained in the EA and review of public comments, a Decision and Finding of No 

Significant Impact (FONSI) for the EA was issued on August 13, 2012. The Decision and FONSI 

selected the proposed action alternative to use federal funds to purchase ONRAB oral vaccine baits and to 

implement expanded ORV field trials involving the distribution of ONRAB oral vaccine baits in select 

areas of New Hampshire, New York, Ohio, Vermont, and West Virginia and to assist in monitoring and 

surveillance efforts by capturing and releasing or killing target species for purposes of obtaining 

biological samples.

II. PURPOSE

The purpose of the EA remains as addressed in section 1.2 of the EA (USDA 2012). The purpose of this 

supplement to the EA is to 1) examine potential environmental impacts of APHIS-WS’ program as it 

relates to expanding the geographic range of the field trial zone in New York, 2) examine potential 

environmental impacts of APHIS-WS’ program as it relates to new information that has become available 

from public comments, research findings, and data gathering since the issuance of the Decision and 

Finding of No Significant Impact (FONSI) in 2012, 3) clearly communicate to the public the analysis of 

individual and cumulative impacts of the proposed action since 2012, and 4) document the analysis of 

WS’ ORV field trial activities in New Hampshire, New York, Ohio, Vermont, and West Virginia since 

the Decision/FONSI was issued in 2012 to ensure that program activities remain within the impact 

parameter analyzed in the EA.

III. NEED FOR ACTION AND PROPOSED SUPPLEMENT

A description of the need for action to control rabies in wildlife populations and to prevent the westward 

movement of the raccoon rabies virus variant is provided in section 1.3 of the EA (USDA 2012). To 

further assess the immunogenicity and safety of the vaccine, APHIS-WS’ National Rabies Management 

Program (NRMP) proposes to expand the geographic area of the ONRAB field trial into Erie, Franklin, 

Jefferson, Lewis, Niagara, St. Lawrence, and Wyoming counties in New York, as analyzed in this 

proposed supplement to the EA (USDA 2012). 

Currently, APHIS-WS conducts an ORV program using the only licensed oral rabies vaccine in the U.S.

[vaccinia-rabies glycoprotein (V-RG)] in the above listed New York counties as part of a national ORV 

program. APHIS-WS’ use of the V-RG vaccine has resulted in several notable accomplishments 

including the elimination of canine rabies from sources in Mexico which had spread to coyotes in south 

1
Texas, the successful control of gray fox rabies virus variant in western Texas, and the prevention of any 

appreciable spread of raccoon rabies in the eastern U.S. While these represent major accomplishments in 

rabies management, the inability to eliminate raccoon rabies from high risk spread corridors prompted the 

need to evaluate vaccine baits capable of producing higher levels of population immunity in raccoons. 

Given promising immunogenicity levels documented during field trials in federal fiscal year (FY)2011 

and FY2012 as well as the need for further field testing, WS proposes to expand future ONRAB trials in 

New York beyond Clinton and Essex counties to also include Erie, Franklin, Jefferson, Lewis, Niagara, 

St. Lawrence, and Wyoming counties (see Figure 1). Expanding field trial activities into the proposed 

additional New York counties would allow APHIS-WS to make critical sero-prevalence comparisons 

between the currently used V-RG vaccine and ONRAB. As depicted in Figure 1, not all of the above 

mentioned counties are expected be included in APHIS-WS’ 2013 field trial bait distribution activities as 

some of the proposed counties could continue to be included in the V-RG bait distribution program. 

However, future ONRAB field trial activities could and are expected to occur in all of the above listed 

New York counties. 

Figure 1: Proposed expanded New York ONRAB field trial zone.

The national rabies management goals of virus variant containment and eventual elimination will likely 

2
remain elusive until an oral vaccine and bait combination is licensed that is immunogenic in all terrestrial 

rabies reservoir species (Slate et al. 2005). The field trial proposed in the EA (USDA 2012) and this 

supplement will help further assess the safety and immunogenicity of ONRAB in meso-carnivore target 

species. Results from these and other studies are often required for licensure of a rabies vaccine for use in 

these species by the vaccine manufacturer.

Additionally, continuing the current ONRAB field trial would allow APHIS-WS to implement three key 

recommendations resulting from the initial 2011 ONRABfield trial (USDA 2012b). It would allow 

APHIS-WS to continue to maintain buffered ONRAB and V-RG zones so that critical comparisons can 

be made between ONRAB and V-RG responses in target species, focus field trial efforts in areas with an 

elevated risk of raccoon rabies spreading to naïve areas to genuinely test this vaccine bait in the face of 

enzootic rabies, and to bolster previous management efforts to prevent raccoon rabies from spreading 

beyond the northern U.S. border into Quebec.

IV. SCOPE OF THE ANALYSIS

The EA (USDA 2012) and this supplement evaluate ORV field trial activities in New Hampshire, New 

York, Ohio, Vermont, and West Virginia. The scope of the analysis remains valid as addressed in the EA 

(see section 1.5 of the EA). This supplement analyzes a proposal to expand the geographic boundary of 

the New York portion of ONRAB field trial to include Erie, Franklin, Jefferson, Lewis, Niagara, St. 

Lawrence, and Wyoming Counties. This supplement to the EA analyzes this expansion with regard to the 

proposed alternative to ensure that continued implementation of the selected alternative would not 

adversely affect the human environment and presents information and data that has become available 

since the completion of the 2012 EA.

Actions Analyzed

The EA and this supplement evaluate the need for APHIS-WS funding of and participation in ORV field 

trials in New Hampshire, New York, Ohio, Vermont, and West Virginia for determining the safety and 

immunogenicity of ONRABas an oral rabies vaccine for meso-carnivores including raccoons and skunks 

in the U.S. Under the proposed action, ORV distribution and monitoring and surveillance activities are

conducted on private, federal, state, county, and municipal lands in New Hampshire, New York, Ohio, 

Vermont, and West Virginia including USDA-Forest Service National Forest System (NFS) lands, but 

excluding Wilderness Areas. This supplement analyzes the potential environmental impacts of expanding 

the geographic range of the field trial in New York with regard to the proposed action. 

Native American Lands and Tribes

APHIS-WS does not conduct ORV activities on tribal lands without the consent of the Tribes. ORV 

activities on tribal lands would occur only pursuant to prior written or oral authorization from the Tribe. 

Because Tribal officials would be responsible for determining what methods would be available during 

ORV field trial bait distribution and monitoring and surveillance activities, no conflict with traditional 

cultural properties or beliefs would be anticipated. The activities and methods addressed in this 

supplement would include those activities that could be employed on Native American lands, when 

requested and agreed upon by the Tribe and WS.

3
Period for which this EA is Valid

If the analysis in this supplement indicates that an environmental impact statement (EIS) is not warranted, 

the EA, as supplemented, would remain valid until APHIS-WS completes the proposed study. If APHISWS makes substantial modifications to the study that would be relevant to environmental concerns, or if 

new circumstances or information relevant to environmental concerns become apparent, a new EA will be 

completed or this EA will be further supplemented pursuant to NEPA and with the appropriate analyses.

Site Specificity

The EA and this supplement analyze potential impacts of ONRAB as an oral rabies vaccine-bait for 

managing rabies in raccoons and skunks in New Hampshire, New York, Ohio, Vermont, and West 

Virginia, including NFS lands, but excluding Wilderness Areas. The scope of the analysis remains valid 

as addressed in the EA (see Section 1.5 of the EA). This supplement analyzes potential environmental 

impacts from expanding the geographic range of the field trial in New York and includes information and 

data made available since the completion of the 2012 EA to ensure that field trial activities under the 

proposed alternative are within the parameters evaluated in the EA and to ensure continued 

implementation of the selected alternative would not adversely affect the human environment.

V. PUBLIC INVOLVEMENT

This supplement to the EA (USDA 2012) will be made available for public review and comment through 

the publication of a notice of availability in the Federal Register, by direct mailing of notices to agencies 

organizations, and individuals with probable interest in ORV programs, and by posting these documents 

and a notice of availability on the APHIS website located at 

http://www.aphis.usda.gov/wildlife_damage/nepa.shtml. Comments received during the public 

involvement process would be fully considered for new substantive issues and alternatives.

VI. RELATIONSHIP OF THE SUPPLEMENT AND EA TO OTHER ENVIRONMENTAL 

DOCUMENTS

Section 1.8 of the EA (USDA 2012) provides a detailed description of those documents containing

information pertinent to the EA and this supplement. 

VII. AUTHORITY AND COMPLIANCE

APHIS-WS’ activities with regard to ORV programs are regulated by federal, state, and local laws and 

regulations. The authority of APHIS-WS is discussed in section 1.9 of the EA (USDA 2012), along with 

the authorities of other federal, state, and local entities. APHIS-WS’ compliance with relevant laws and 

regulations are also discussed in detail in section 1.9 of the EA (USDA 2012). APHIS-WS’ authorities 

and those of federal, state, and local entities would remain as addressed in the EA, including compliance 

with all applicable federal, state, and local laws and regulations. 

VIII. ISSUES ANALYZED IN DETAIL

Issues are concerns raised regarding potential environmental problems that might occur from a proposed 

action. The following issues, identified during the scoping process for the EA and discussed in detail in 

Chapter 2 of the EA (USDA 2012) are analyzed in detail in this supplement with regard to the proposed 

4
geographic expansion of APHIS-WS’ ONRAB field trial into Erie, Franklin, Jefferson, Lewis, Niagara, 

St. Lawrence, and Wyoming counties in New York:

• Potential for adverse effects on target wildlife species populations.

• Potential for adverse effects on nontarget wildlife species, including threatened and endangered 

species.

• Potential for adverse effects on people, pets, and livestock that are exposed to or consume the vaccine 

laden baits.

• Potential for ONRAB to “revert to virulence” or recombine with other viruses and result in a virus 

that could cause disease in humans.

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

• Humaneness of methods used to collect wild animal species critical for timely program evaluation.

IX. ISSUES ADDRESSED BUT NOT ANALYZED IN DETAIL WITH RATIONALE

In addition to the identified major issues considered in detail, 10 additional issues were considered in 

section 2.2 of the EA, but were not analyzed in detail with rationale provided in the EA (USDA 2012). 

APHIS-WS has reviewed the issues not considered in detail as described in the EA and has determined 

that the analyses provided in the EA are still appropriate regarding those issues.

X. AFFECTED ENVIRONMENT

The affected environment was described in section 2.3 of the EA (USDA 2012). APHIS-WS is proposing 

to expand the geographic boundary of the field trial in New York. Currently, as analyzed in the EA 

(USDA 2012), the ONRAB field trial zone in New York includes Clinton and Essex Counties. APHISWS is proposing to expand the ONRAB field trial zone in New York to include the following counties: 

Erie, Franklin, Jefferson, Lewis, Niagara, St. Lawrence, and Wyoming (see Figure 1).

The potential area involved in the ORV program field trial may cover several land ownership types and 

diverse land uses, including cultivated agricultural lands, forests, meadows, wetlands, pastures, and 

developed lands. Aerial distribution of ORV baits would avoid urban and suburban areas that support 

high human population densities, as well as lakes and rivers. Aerial distribution of baits would primarily 

target rural areas as well as known areas of suitable target species habitat. When aerial distribution by 

fixed-wing or helicopter aircraft is not practical, baits would be distributed by careful hand placement to

help minimize contact by humans, pets, and other domestic animals.

Figure 2 shows the areas within the proposed states where APHIS-WS would participate in ORV field 

trials under the proposed action, as supplemented, and the approximate V-RG ORV bait distribution 

zones. In addition, the ORV bait dispersal areas are also the primary expected areas where assistance by 

APHIS-WS is expected to be requested to collect blood, tooth and other biological samples from target 

5
animals for monitoring and surveillance. 

Figure 2: Proposed ONRAB and V-RG distribution zones (with bait distribution densities of 75/km2 and 150/km2).

XI. ALTERNATIVES

The alternatives considered and evaluated using the identified issues are described and discussed in detail 

in Chapter 3 of the EA (USDA 2012). In addition, the EA contains a detailed description and discussion 

of the alternatives and the effects of the alternatives on the issues identified (USDA 2012). The EA also 

provides a description of the methods that could be used or recommended by APHIS-WS under each of 

the alternatives. The EA describes three alternatives that were developed to address the issues identified 

above. The following alternatives were developed for this supplement to address the issues identified 

above:

Alternative 1. Maintain Status Quo This alternative would involve the use of federal funds to 

maintain the status quo of the ONRAB field trials in New Hampshire, New York, Ohio, Vermont, and 

West Virginia, as described in the 2012 EA and the decision and Finding of No Significant Impact 

(FONSI) for the EA issued on August 13, 2012. 

6
Alternative 2. Proposed Action (the Preferred Alternative). This alternative would involve the use of 

federal funds to expand the geographic range of the ONRAB field trials, described in the EA (USDA 

2012), to include Erie, Franklin, Jefferson, Lewis, Niagara, St. Lawrence, and Wyoming counties in New

York, as proposed in this supplement. Under this alternative, APHIS-WS would use federal funds to 

purchase ONRAB oral vaccine-baits and to participate in ORV field trials involving the distribution of 

ONRAB oral vaccine-baits under the authorities of the appropriate state agencies in New Hampshire, 

New York, Ohio, Vermont, and West Virginia to evaluate the immunogenic and safety characteristics of 

the ONRAB vaccine for wildlife rabies under limited field conditions. Under this alternative, as 

described in the 2012 EA and this supplement, APHIS-WS would also assist in monitoring and 

surveillance efforts by capturing and releasing or killing target species for purposes of obtaining 

biological samples.

Alternative 3. No ORV Field Trials. Under this alternative, there would be no involvement by APHISWS in ORV field trials in the states identified in Section 1.4 of the EA (USDA 2012) or in any of the 

additional New York counties proposed in this supplement. 

XII. ALTERNATIVES CONSIDERED BUT NOT ANALYZED IN DETAIL

Three additional alternatives were considered, but not analyzed in detail in the EA (see section 3.2). 

APHIS-WS has reviewed the alternatives not analyzed in detail in the EA and has determined that the 

analysis provided in the EA has not changed and is still appropriate with regard to APHIS-WS’ proposed 

geographic expansion of the ONRAB field trial into Erie, Franklin, Jefferson, Lewis, Niagara, St. 

Lawrence, and Wyoming as analyzed in this supplement to the EA. 

XIII. STANDARD OPERATING PROCEDURES

APHIS-WS has adopted Standard Operating Procedures (SOPs) that serve to prevent, reduce, or 

compensate for negative impacts that otherwise might result from an action. The current ORV programs, 

including field trials, use many such SOPs that would be incorporated into the expanded field trial 

activities. The SOPS discussed in the EA (see section 3.3) remain appropriate for APHIS-WS’ ONRAB 

field trial, including the proposed expansion into Erie, Franklin, Jefferson, Lewis, Niagara, St. Lawrence, 

and Wyoming counties in New York as analyzed in this supplement.

XIV. ENVIRONMENTAL CONSEQUENCES

The major issues are discussed in detail in Chapter 2 of the EA (USDA 2012). Alternatives developed 

and identified during the development of the EA to meet the need for action and to address those issues 

are discussed in Chapter 3 of the EA (USDA 2012). The potential impacts of Alternative 1 and 

Alternative 3 on the human environment have not changed from those described and analyzed in the EA 

and, thus, do not require additional analyses in this supplement. Chapter 4 of the EA contains a detailed 

discussion and comparison of the identified alternatives and the major issues (USDA 2012). Alternative 

2 (proposed action), as described in the EA, addresses the need and implementation of ORV field trials 

using the ONRAB vaccine by APHIS-WS. The following is an analysis of potential impacts of 

Alternative 2 (proposed action) for each of the major issues analyzed in the EA since the completion of 

the EA and includes consideration of seven additional counties (Erie, Franklin, Jefferson, Lewis, Niagara, 

St. Lawrence, and Wyoming) within the New York State portion of the proposed ONRAB field trial zone:

7
Issue 1 – Potential for adverse effects on target wildlife species populations.

The primary concern is whether the ONRAB vaccine-bait might cause disease in target raccoons and 

striped skunks, the target species in this ONRAB field trial, if they consume this vaccine-bait. In order 

for such vaccines to be licensed for use they must be shown to be safe, pure, potent, efficacious, and 

genetically stable (Agriculture Canada 1989). 

The EA (USDA 2012) includes discussion of studies conducted by Charlton et al. (1992), Prevec et al. 

(1990), and Knowles et al. (2009) documenting the safety of AdRg1 and ONRAB in ORV target species 

including raccoons, foxes, and skunks. Additionally, the EA presents findings from previous field trial 

studies conducted in Canada.

In 2011, raccoons sampled by APHIS-WS during post-ONRAB ORV monitoring and surveillance 

activities displayed a 49.2% seroconversion rate (n=262) (i.e., these raccoons received a sufficient dose of 

ONRAB and are considered to be vaccinated against the rabies virus). While raccoons sampled preONRAB ORV activities displayed a 9.6% (n=395) seroconversion, this may be explained by a possible 

occurrence of naturally acquired immunity from sub-lethal exposures to raccoon rabies or movements of 

orally vaccinated raccoons into sampling cells from the adjacent V-RG zone (USDA 2012b). 

The 49% post-ORV with ONRAB (uncorrected for the 9.6%) seroconversion represents the highest rabies 

virus neutralizing antibody (RVNA) level that WS has observed after an initial baiting of a naïve area at 

75 baits/km2 where baselines had been measured prior to ORV. Biomarker presence was also 

significantly higher among seropositive raccoons post-ORV and similar among raccoons during the preORV sampling period (USDA 2012b).

Recently, a study focusing on immune response in raccoons following treatment with ONRAB (Brown et 

al. 2012) found similar, promising results. In this study, forty two wild-caught, captive raccoons were 

offered an ONRAB vaccine bait. Results of this study concluded that ONRAB effectively stimulated the 

production of RVNA in a high proportion of raccoons (67%) within the first two months after 

vaccination. Twenty of these ONRAB treated raccoons were later challenged with rabies virus infection. 

Of these raccoons, fifteen (75%) survived rabies virus challenge. Throughout the study, no vaccineinduced morbidity or mortality was observed among raccoons (Brown et al. 2012). 

Field studies using ONRAB in Ontario, Canada have reported vaccine efficacy in raccoons in the wild 

ranging from 79% to 81% using baiting densities similar to APHIS-WS’ ORV programs (i.e., 75-150 

baits/km2

) (Rosatte 2009). Further studies have compared field performance between ONRAB and VRG. In 2008, ORV programs in Maine, distributing V-RG baits, and New Brunswick, Canada, 

distributing ONRAB baits, provided an opportunity to carry out a comparative analysis of the field 

performance of these two vaccine-baits in skunks and raccoons (Fehlner-Gardiner et al. 2012). While 

antibody prevalence in skunks was low in both Maine and New Brunswick, Fehlner-Gardiner et al. (2012) 

concluded that this may be attributed to bait densities and flight line spacing. Samples collected from 

raccoons receiving ONRAB baits in New Brunswick showed antibody response rates ranging from 67% 

to 78%, depending on the test used for analysis. Conversely, samples from raccoons receiving V-RG 

baits in Maine showed lower antibody response rates of 25% to 32%. Although a number of factors, as 

described by Fehlner-Gardiner et al. (2012), could have impacted the interpretation of antibody data, 

8
many of these factors would have favored the V-RG results in Maine. The antibody prevalence in 

raccoons achieved in this study using ONRAB suggests that this vaccine may prove effective not only for 

the prevention of raccoon rabies in enzootic areas, but also for rabies elimination (Fehlner-Gardiner et al. 

2012). Mainguy et al. (2013) conducted a similar cross-border comparison between ONRAB and V-RG. 

This study examined antibody response rates between raccoon receiving ONRAB baits in Quebec, 

Canada versus raccoons receiving V-RG in neighboring Vermont. This study found that the percentage 

of antibody-positive raccoons was greater with ONRAB in Quebec (51%) than with V-RG in Vermont 

(38%) although field conditions, similar to those in the above mentioned New Brunswick-Maine study, 

should have favored a higher antibody prevalence in Vermont. 

APHIS-WS expanded the ONRAB field trials in 2012 to portions of New Hampshire, New York, Ohio, 

Vermont, and replicated the 2011 trial in West Virginia. While serology results are currently pending, it 

is expected that results will be similar to those experienced in 2011.

As discussed in section 4.1.1 of the EA (USDA 2012), post-field trial ORV monitoring and surveillance

activities conducted to evaluate the safety and effectiveness of the ONRAB vaccine-bait are expected to 

have negligible adverse risks or impacts to target species populations. Expanding the geographic area of 

ONRAB field trials into Erie, Franklin, Jefferson, Lewis, Niagara, St. Lawrence, and Wyoming counties 

in New York will continue to result in negligible adverse risks to target species populations with regard to 

monitoring and surveillance activities. APHIS-WS and cooperating state and local agencies continue to 

expect to humanely kill less than 1% of the lowest number of raccoons in all ORV program states, 

including any raccoons that may be humanely killed for critical samples during ONRAB field trials. The 

current V-RG ORV program conducts raccoon monitoring and surveillance activities in 17 eastern states. 

To date, lethal removal has accounted for less than 0.03% - 0.19% of the lowest estimated raccoon 

population annually (USDA 2011c, 2009, 2008, 2007, 2005, 2004, 2004b, 2003) for all ORV programs. 

APHIS-WS rabies management program’s lethal removal of far less than 1% of raccoons did not reduce 

statewide or regional densities of raccoons. A review of monitoring and surveillance data (USDA 2011c, 

2009, 2008, 2007, 2005, 2004, 2004b, 2003) indicates that the potential for cumulative impacts to raccoon 

populations continues to be negligible. Additionally, based on the conservative state-wide striped skunk 

population estimates for NH, NY, OH, VT, and WV described in section 4.1.1 of the EA, APHIS-WS and 

cooperating state and local agencies continue to expect to lethally remove less than 1% of the total striped 

skunk population in any of the involved states.

In the absence of the ORV program, including the proposed field trial, it is highly likely that substantially 

greater numbers of raccoons would succumb to the invariably fatal rabies virus with other animal and 

public health implications than are removed during monitoring and surveillance activities.

Although the ORV ONRAB field trial specifically targets raccoons and striped skunks, several other 

species may be treated as targets for monitoring and surveillance. These species are referred to as nonORV targets for purposes of the EA (USDA 2012) and this supplement. The methods proposed for use in 

monitoring and surveillance activities would have no significant adverse effects on non-ORV target 

species. Species that are considered targets for monitoring and surveillance, but are not targets for the 

ORV ONRAB field trial will include all known rabies reservoir or common vector species , including: the

red fox, grey fox, coyote, spotted skunk (Spilogale putoris), bobcat (Lynx rufus), fisher (Martes 

9
pennanti), groundhog (Marmota monax), feral dog (Canis familiaris), and feral cat (Felis domesticus). 

Additionally, several small mammal species may be targets for monitoring and surveillance including 

Eastern chipmunk (Tamias striatus), Eastern gray squirrel (Sciurus carolinensis), red squirrel 

(Tamiasciurus hudsonicus), Southern flying squirrel (Galucomys volans), short-tailed shrew (Blarina 

brevicauda), deer mouse (Peromyscus maniculatus), white-footed mouse (Peromyscus leucopus), 

Southern red-backed vole (Clethrionomys gapperi), meadow vole (Microtus pennsylvanicus), and pine 

vole (Microtus pinetorum). Occasionally, samples may be collected for serology from some mammal 

species that are incidentally captured during ORV monitoring and surveillance activities, but not 

specifically targeted by the ORV ONRAB field trials. They may be opportunistically sampled to 

determine the potential effectiveness of ONRAB as many of these species have a propensity for 

contracting, harboring, and spreading the rabies virus. Non-ORV target animals captured in cage traps 

would normally be released unharmed unless the animal appears sick or injured. Therefore, monitoring 

and surveillance should have little or no effect on non-ORV target populations as a result of the proposed 

geographic expansion of field trial activities in New York.

While expanding the geographic area of the field trial in New York should expose higher numbers of 

target animals to the ONRAB, based on the safety data presented above and in the EA (USDA 2012), as 

well as APHIS-WS’ continued limited lethal removal (i.e., less than 1% of target species populations), no 

adverse effects to target animals is expected. Beneficial impacts to target species may be expected as 

previous studies indicate higher levels of rabies antibody response in animals treated with ONRAB versus 

V-RG.

Issue 2 – Potential for adverse effects on nontarget wildlife species, including threatened and 

endangered species.

The issue of nontarget species effects, including effects on threatened and endangered species, arises from

the potential consumption of wildlife vaccines and the use of monitoring and surveillance methods as 

described in the EA (USDA 2012). 

As discussed in section 4.1.2 of the EA (USDA 2012), at least 17 species have been included in the safety 

studies on ONRAB (Knowles et al. 2009) from several taxonomic groups. No adverse reactions in the 

animals studied were found following oral inoculation of the experimental vaccine, while, in most cases,

antibodies against the rabies viral protein were detected on day 28 post-exposure (CFIA 2008, 2010). 

Test animals were found to be clinically healthy after vaccination with ONRAB; however, viral nucleic 

acids were detected in some tissues or feces of some vaccinated animals, suggesting that ONRAB was 

replicating or persisting in these hosts for a few days to a couple of weeks post-vaccination. Replication 

of adenovirus in immunocompromised animals such as nude mice and severe combined immunodeficient 

(SCID) mice did not appear to result in adverse reactions (CFIA 2008, 2010). Over dosage of ONRAB in 

amounts four to five times greater than the dose found in the vaccine baits resulted in no adverse effects 

in experiments involving skunks and raccoons (Artemis 2010). 

Subsequent to the completion of the EA (USDA 2012), APHIS-WS’ National Wildlife Research Center 

(NWRC) conducted research expanding on the species evaluated by Knowles et al. (2009) to investigate

the safety of ONRAB in wildlife species likely to come into contact with the vaccine-bait as a result of 

WS’ ORV distribution (Fry et al. 2013). A 10x dose of ONRAB was administered to Eastern wild 

10
turkeys (Meleagris gallopavo silvestri), opossums (Didelphis virginiana), cottontail rabbits (Sylvilagus 

floridanus), fox squirrels (Sciurus niger), and woodrats (Neotoma spp.). Oral swabs, feces, and blood 

samples were collected from all species. Following inoculation, no behavior changes were observed in 

any of the animals. By 7 days post-inoculation (dpi) no viral DNA was detected in the fecal swabs of 

turkeys, opossums, or cottontails and by 21 dpi no viral DNA from fecal swabs was detected in any of the 

individuals. At 7 dpi oral shedding was detected in only three of the treated fox squirrels. The limited 

viral recovery through both oral and fecal routes is of minimal concern regarding potential persistence of 

ONRAB in nontarget species (Fry et al. 2013). Post-mortem examination did not reveal gross or 

histopathological pathology that could be linked to the vaccine. These study results suggest low 

likelihood or persistence of ONRAB in the environment or in individual animals that contact the vaccine 

even at ten times the desired dose (Fry et al. 2013). Based on the study results, Fry et al. (2013) 

determined that there was no reason to conclude that ONRAB would have detrimental effects on 

nontarget wildlife species that incidentally ingest ONRAB during ORV campaigns in the U.S. Similarly, 

the distribution of ONRAB to control the spread of rabies in Canada has not resulted in any concern 

regarding nontarget species.

The methods proposed for use in ONRAB field trial monitoring and surveillance areas, including the 

proposed geographic expansion in New York, would have no significant adverse effects on nontarget 

species. Nontarget animals captured in cage traps would normally be released unharmed unless the 

animal appeared injured or sick. Therefore, monitoring and surveillance should have no effect on 

nontarget species populations. Analysis of nontarget take resulting from other APHIS-WS ORV 

programs can be found in USDA 2010.

Special efforts are made to avoid jeopardizing T&E species through biological evaluations of the potential 

effects and the establishment of special restrictions or mitigation measures. Mitigation measures and 

SOPs to avoid T&E effects are described in section 3.3 of the EA (USDA 2012).

APHIS-WS reviewed lists of federal and state T& E species (Appendices A and B), as well as Regional 

Forester Sensitive Species (Appendix C) to determine if any species might be affected due to new listings 

since the completion of the EA (USDA 2012) or the presence of T&E species in the additional New York 

counties (Erie, Franklin, Jefferson, Lewis, Niagara, St. Lawrence, and Wyoming). No new listings or 

presence of T&E species in the expanded New York counties were identified beyond those that have been 

previously analyzed (USDA 2012). ORV programs or the methods used in capture and removal target 

species during monitoring and surveillance activities would continue to have no effect on listed fish, 

invertebrate, or plant species, as described in the EA (USDA 2012). 

Although no T&E species were specifically tested for safety of ONRAB baits, safety studies involving 

ONRAB on other species representing 11 unique taxonomic families (see EA Section 4.12) indicate that 

no species will be affected by the baits (Knowles et al. 2009, Randrianarison-Jewtoukoff and Perricaudet 

1995, Artemis 2010).

APHIS-WS has determined that the proposed expansion of ONRAB field trials will not result in adverse 

effects to nontarget species, including T&E species, in the additional counties (Erie, Franklin, Jefferson, 

Lewis, Niagara, St. Lawrence, and Wyoming) in New York where the trials will be conducted. Further, 

the proposed program could have an indirect beneficial effect by reducing the chances that nontarget and 

11
T&E species are exposed to the rabies virus in the wild. 

Issue 3 – Potential for adverse effects on people, pets, and livestock that are exposed to or consume 

the vaccine laden baits.

The recombinant virus used as the ONRAB vaccine-bait cannot cause rabies. This is because the 

ONRAB 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 which 

would be required for the disease to occur. Implementation of ORV programs would reduce the risk of 

human exposure to rabies by reducing the chance of encountering rabid animals that have been infected 

by rabid raccoons, striped skunks, foxes, or coyotes.

Over 150 million doses of ORV utilizing V-RG have been distributed in the U.S. since the early 1990s. 

Human contact with V-RG has been rare, with only two reported human Vaccinia infections having 

occurred from vaccine exposure. However, ONRAB is an alternative that may have a different human 

safety profile than V-RG given the high prevalence of antibodies in humans to adenovirus type 5 as well 

as the generally mild illness that may result from infection with this virus (CDC 2013). The ONRAB 

vaccine employs a human adenovirus type 5 vector into which has been inserted a glycoprotein gene from 

the ERA rabies vaccine virus. While this live human adenovirus-vectored rabies vaccine virus could 

cause infection in humans accidentally breaking open the bait packages, if the person is not already 

immune (CFIA 2008, 2010), adenovirus infections are ubiquitous and are normally without significant or 

severe clinical symptoms. Adenoviruses are distributed worldwide and infections with human adenovirus 

type 5 do not typically result in serious disease (Rowe et al. 1995, Andiman and Miller 1982, Charlton et 

al. 1992, Russell 1998 in Rosatte et al. 2009). Although there will be a slight increase in the numbers of 

humans who may be exposed to ONRAB vaccine-baits, it is unlikely that the effects will vary 

significantly from those analyzed in section 4.1.3 of the EA. The effects of Ad5 will remain unchanged 

with APHIS-WS’ proposed field trial expansion into the NY counties of Erie, Franklin, Jefferson, Lewis, 

Niagara, St. Lawrence, and Wyoming.

Exposures1 to ONRAB baits have remained relatively low, as discussed in section 4.1.3 of the EA 

(USDA 2012) and since the completion of the EA. Following the distribution of approximately 80,000 

ONRAB baits during the 2011 field trial in West Virginia, there were no reports of human or pet related 

bait contacts (USDA 2012b). The CDC (2013) reported that following the distribution of 272,034 

ONRAB and 504,887 V-RG baits over an area of 11,341 km2 in Ohio during 2012, 89 baits were reported 

to have been found. Of these, 15 baits found were ONRAB(5.5 baits found per 100,000 ONRAB baits 

distributed) and 74 were V-RG (14.7 baits found per 100,000 distributed). Also, during this time there 

were 14 occurrences of human contacts

1 with ONRAB baits versus 41 human contacts resulting from the 

V-RG baits distributed in Ohio (Table 1). This equates to 5 contacts per 100,000 baits distributed and 8 

contacts per 100,000 baits distributed, respectively. There were no reported adverse events related to 

human-bait contacts. 

Table 1. Human Contacts with ORV Baits in Ohio, 2012 (CDC 2013).

# Bait Contacts # Baits Distributed # Bait Contacts/100,000 Baits 

Distributed

ONRAB 14 272,034 5

V-RG 41 504,887 8

1 “Exposures” and “contacts” for purposes of this document include all reported calls whether baits were actually touched or not. For instance, 

callers may have noticed baits in their yards or on roads, but it does not necessarily mean that they touched or moved the baits. In other

situations, people may have picked up a bait with gloves and threw it into the woods or garbage.

12

 
Among the 55 human contacts in Ohio, 27 involved baits that were not intact and a barrier (e.g., gloves) 

had not been used to handle the bait, leaving persons at risk for vaccine exposure and vaccine virus 

infection (CDC 2013). However, no adverse events were reported. Table 2, below, shows the number of 

human contacts in Ohio and those contacts resulting in potential vaccine exposure by year and bait type as 

reported by the CDC (2013).

Table 2. Reported Number of Human Contacts with Oral Rabies Vaccine Baits and Number and Percentage of Contacts with Potential 

Vaccine Exposure, by Year and Bait Type – Ohio, 2010-2012 (CDC 2013).

Year/Bait Type No. of Human Contacts No. of Contacts with 

Potential Vaccine Exposure

(%)

2010 V-RG 83 37 (45)

2011 V-RG 83 29 (35)

2012 (total) 55 27 (49)

2012 ONRAB 14 11 (79)

2012 V-RG 41 16 (39)

During ORV programs between 2009 and 2011 there was an average of 20 bait contacts per 100,000 baits 

distributed in Ohio compared to an average of 6 bait contacts per 100,000 baits distributed in all U.S. 

states participating in ORV programs (Table 3) (CDC, unpublished data).

Table 3. Comparison of Human Contacts with ORV Baits in Ohio in Comparison to all U.S. ORV States (CDC 2013 and unpublished 

data).

V-RG Bait Contacts # Baits Distributed # Bait Contacts/100,000 

Baits Distributed

OH U.S. OH U.S. OH U.S.

2009 203 583 874,301 9,572,753 23 6

2010 155 744 774,714 8,868,939 20 8

2011 159 319 863,215 7,920,640 18 4

While contact rates for both ONRAB and V-RG are higher in Ohio than the programmatic average for all 

states involved in ORV programs, this may be explained given the significantly higher number of ORV 

baits distributed in Ohio, as well as, the human population density in the baiting area and the bait contact 

reporting mechanisms in place.

As discussed above, there were no reported bait contacts during the 2011 ONRAB field trial in WV. 

Further, during ORV programs in Ontario, Canada, a total of 432,000 ONRAB baits were distributed 

resulting in 6 reports of the public finding baits (D. Donovan, pers. comm., 2012) and 700,000 ONRAB 

baits were distributed in Quebec, Canada, resulting in only 1 report of the public finding a bait (J. 

Mainguy, pers. comm., 2012). 

These minimal numbers of reports, along with the relatively low number of contacts in Ohio during 2012 

indicate that public contact rates with ONRAB baits can be expected to remain low throughout the 

proposed ORV field trial zone. Hazards to public safety are not expected. The information discussed in 

the EA (USDA 2012) indicates a low potential exists for unusual circumstances to result in short-term 

adverse health effects from exposure to the human adenovirus type 5 in the ONRABvaccine. The EA 

(USDA 2012) concluded that the overall risk of such effects appears to be minimal based on the 

extremely low rate of reported occurrences in ORV programs. The new data presented in this supplement 

further supports this conclusion.

13
Section 4.1.3.1 of the EA (USDA 2012) concluded that ONRAB field trials would have only a negligible 

risk of adversely affecting pets or other domestic animals that are exposed to or consume the vaccine 

laden bait. Following the 2012 ORV bait distribution in Ohio, there were 38 reports involving domestic 

dogs, resulting in 3 adverse events (CDC 2013). One adverse event involved an ONRAB bait that 

temporarily obstructed a dog’s airway, but the dog survived. The remaining two events involved 

vomiting or regurgitation following consumption of V-RG baits. There were no other reports of domestic 

animal exposures. There were fewer reports of domestic animal exposures in Ohio during 2012 than 

during the preceding three years in the same general area (CDC, unpublished data) (see Table 4). 

Domestic animal contacts with baits are typically much lower in the remaining states where APHIS-WS 

distributes ORV baits and is likely due to the factors described above for human contact rates (e.g., 

human/pet population densities in the baiting area, number of baits distributed in a particular area, and 

reporting mechanisms). APHIS-WS expects that the rate of domestic animal contacts with ORV baits 

will remain unchanged under the proposed action. Impacts of the program on this issue are expected to 

remain negligible. 

Table 4. Comparison of domestic animal to ORV bait contact rates in Ohio verses all U.S. ORV states2 (CDC unpublished data).

Ohio U.S.

# Bait Contacts # Baits 

Distributed

# Bait Contacts 

(avg.)

# Baits 

Distributed

2009 79 874,301 13 9,572,753

2010 74 774,714 22 8,868,939

2011 69 863,215 15 7,920,640

2012 38 776,921 N/A 7,299,174

Issue 4 - Potential for ONRAB to “revert to virulence” or recombine with other viruses and result 

in a virus that could cause disease in humans.

The concern is whether the ONRAB recombinant virus vaccine is genetically stable so that it would not 

become virulent (i.e., capable of causing disease) after it replicates (or reproduces) in animals that eat 

ORV baits containing the vaccine, followed by the transmission and whether the ONRAB might come 

into contact with other viruses within infected cells of animals, exchange genetic material with them 

during replication, and result in new viruses that could cause more serious diseases in humans or animals. 

Based on the analysis in the EA (USDA 2012), ONRAB is highly genetically stable and has not shown

evidence of substantial mutation during passage studies (Lutz-Wallace et al. 1995a, 1995b). Additionally, 

as discussed in section 4.1.4 of the EA (USDA 2012), recombination of the ONRAB vaccine is highly 

unlikely. However, if it were to occur, it is equally unlikely that the result would yield a viable, 

transmissible virus (CDC 2011b). APHIS-WS believes this issue was adequately addressed in the EA 

and the effects of this issue will remain unchanged under the proposed program.

Issue 5 – Potential for aerially dropped baits to strike and injure people or domestic animals.

As discussed in section 4.1.5 of the EA (USDA 2012), under the proposed program baits will be 

distributed at common densities of 75 baits/km2 (194 baits/mi2

) or 150 baits/km2 (388 baits/mi2). These

densities are sparse enough to predict that the chance of a person being struck and harmed by falling bait 

is remote. The negligible risk of being struck is further supported by the fact that out of more than 100 

2 U.S. Domestic animal bait contact rates represent an average of the contacts reported for each state involved in ORV distribution as reported by 

the states to the CDC.

14

 
million baits distributed in the U.S. by APHIS-WS during other ORV programs between 1995 and 2011, 

only 11 incidents have been reported in which a person claimed to have been struck by a falling bait 

(0.00001% chance of being struck by a bait or 1 strike per 9.1 million baits dropped) (USDA 2011c). 

None of the reports since APHIS-WS’ ORV program inception have resulted in injury or harm to the 

individuals involved. In addition, trained aircrews avoid baiting in cities, towns, and other areas with 

human dwellings, or if humans are observed below. In areas with higher human density, ground 

placement of baits is normally used. These techniques used by APHIS-WS’ current ORV programs 

would also be employed during the ONRAB field trials.

Although APHIS-WS is proposing to distribute ONRAB over a wider geographic area in the New York

State portion of the field trial zone, the analysis in the EA (USDA 2012) as well as the EA for APHISWS’ current V-RG ORV program (USDA 2009) indicates that APHIS-WS’ ORV programs, including the 

proposed field trial, pose minimal potential for adverse effects regarding this issue.

Issue 6 – Humaneness of methods used to collect wild animal species critical for timely program 

evaluation.

As discussed in the EA (USDA 2012), humaneness, in part, appears to be a person’s perception of harm 

or pain inflicted on an animal. People may perceive the humaneness of an action differently. The 

challenge in coping with this issue is how to achieve the least amount of animal suffering within the 

constraints imposed by current technology and funding.

Some individuals believe any use of lethal methods to resolve damage associated with wildlife is 

inhumane because the resulting fate is the death of the animal. Others believe that specific types of

methods can lead to a humane death. Others believe most non-lethal methods of capturing wildlife to be 

humane because the animal is generally unharmed and alive. Still others believe that any disruption in the 

behavior of wildlife is inhumane. With the varied attitudes on the meaning of humaneness, the analyses 

must consider the most effective way to address damage and threats caused by wildlife in a humane 

manner. The goal of WS is to use methods as humanely as possible to effectively resolve requests for 

assistance to reduce damage and threats to human safety. WS continues to evaluate methods and 

activities to minimize the potential for pain and suffering of wildlife when attempting to resolve requests 

for assistance. 

As mentioned previously, some methods have been stereotyped as “humane” or “inhumane”. However, 

many “humane” methods can be inhumane if not used appropriately. For instance, a cage trap is 

generally considered by most members of the public as “humane”. Yet, without proper care, livecaptured wildlife in a cage trap can be treated inhumanely if not attended to appropriately.

Therefore, WS’ mission is to effectively address requests for assistance using methods in the most 

humane way possible that minimize the stress and pain of the animal. WS’ personnel are experienced and 

professional in their use of management methods, and methods are applied as humanely as possible. 

Since those methods described in the EA (USDA 2012) would continue to be available under the 

proposed supplement to the EA, the issue of humaneness would be similar despite the frequency of the 

use of methods increasing. Those methods considered inhumane by certain segments of society would be 

considered inhumane in spite of the frequency of use. Further, any increase in the use of methods would 

be exceedingly minimal as APHIS-WS currently conducts operational ORV programs in the area of the 

proposed field trial and would likely continue to do so even in the absence of field trials. Therefore, the 

15
analyses of the humaneness of methods used by WS to conduct ORV field trial in the interest of 

eliminating rabies in wildlife has not changed from those analyzed in the EA (USDA 2012).

XV. CUMULATIVE IMPACTS

Cumulative impacts, as defined by CEQ (40 CFR 1508.7), are impacts to the environment that result 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 actions. Cumulative 

impacts may result from individually minor, but collectively significant, actions taking place over time. 

No significant cumulative environmental impacts have resulted from implementation of APHIS-WS’ 

ORV program, including ONRAB field trials. It is possible that Alternative 1 (Maintain the Status Quo) 

and Alternative 3 (No ORV Field Trials, as analyzed in the EA (USDA 2012), might indirectly lead to 

increased human exposures and domestic and wild animal rabies cases across the U.S. As discussed in 

Chapter 4 of the EA (USDA 2012) and this supplement, APHIS-WS and cooperating state and local 

agencies expect to continue to live-trap or humanely kill less than one percent of the lowest estimated 

number of the target species combined for monitoring and surveillance purposes or implementation of 

contingency plans involving lethal population reduction in all of APHIS-WS’ ORV programs, including 

the ONRAB field trial. 

Additionally, as discussed in Chapter 4 of the EA and this supplement, the potential for adverse effects 

resulting from the recombination of ONRAB with other adenoviruses is negligible. It is unlikely that an 

exchange of genetic material with wild-type viruses would occur in the field. Even if it did occur, the 

event would not be expected to generate a more virulent virus than the already present wild-type virus 

(USDA 2011a). Broadening the distribution of ONRAB will not alter this potential.

XVI. SUMMARY

Impacts associated with activities under consideration here are not expected to be “significant”. Although 

some persons will likely remain opposed to the use of recombinant vaccines or the use of human 

adenovirus type 5 as a component of ORV, and some will remain opposed to the lethal removal of 

raccoons, skunks, and other wild animals for monitoring, surveillance and to evaluate program progress 

and success, the analysis in APHIS-WS’ ORV EAs (USDA 2009, 2012) and this supplement indicate that 

ORV and lethal removal for critical sampling and surveillance will not result in significant risk of 

cumulative adverse impacts on the quality of the human environment. Risks to nontarget species from the 

proposed program are very low and unlikely to contribute to existing impacts on nontarget species. 

However, containment and eventual elimination of the rabies virus would have beneficial impacts to both 

target and nontarget wildlife species susceptible to the rabies virus. Risks to public safety are low.

The addition of those impacts to others associated with past, present, and reasonably foreseeable future 

actions, as described in USDA (2010) and USDA (2012), will not result in cumulatively significant 

environmental impacts. Monitoring the impacts of the program on the populations of both target and 

nontarget species will continue. All ORV activities that may take place will comply with relevant laws, 

regulations, policies, orders, procedures including the Virus-Serum-Toxin Act; Federal Food, Drug, and 

Cosmetic Act; and the Animal Medicinal Drug Use Clarification Act of 1994. Table 4.2 of the EA 

(USDA 2012) presents a summary of relative comparisons of the anticipated impacts of each of the 

16
alternatives as they relate to each of the major issues identified in Chapter 2 of the EA. 

XVII. ACRONYMS

AdRG1.3 Human Adenovirus Type-5 Rabies Glycoprotein Recombinant Vaccine

APHIS Animal and Plant Health Inspection Service

CDC Centers for Disease Control and Prevention

CEQ Council on Environmental Quality

CFR Code of Federal Regulations

EA Environmental Assessment

EIS Environmental Impact Statement

FONSI Finding of No Significant Impact

FR Federal Register

ORV Oral Rabies Vaccination

NEPA National Environmental Policy Act

NFS National Forest System

NPS National Park Service

NRMP National Rabies Management Program

RVNA Rabies Virus Neutralizing Antibodies

SCID Severed Combined Immunodeficient

SOP Standard Operating Procedure

T&E Threatened and Endangered

TVR Trap Vaccinate Release

USDA United States Department of Agriculture

USDI United States Department of the Interior

USFS United States Forest Service

WS Wildlife Services

V-RG Vaccinia-Rabies Glycoprotien

USFWS United States Fish and Wildlife Service

XVIII. LITERATURE CITED

Agriculture Canada. 1989. Guidelines for the regulation of veterinary biologics produced by 

biotechnology. Nepean, Ontario: Veterinary Biologics and Biotechnology Section, Animal Health 

Division, Cat. No. A62-43/1989E.

Andiman, W. and G. Miller. 1982. Persistent infection with adenovirus type 5 and 6 in lymphoid cells 

from humans and woolly monkey. J. Wild. Dis.: 145: 83-88.

Artemis Technologies, Inc., 2010. Information for the environmental assessment of rabies vaccine, live 

adenovirus vector, (AdRG1.3) for the immunization against rabies of striped skunks in Ontario. 51 

Watson Road South, Guelph, Ontario, N1L 1E3.

Baer G.M. 1988. Oral rabies vaccination: an overview. Rev. Infect. Dis. 10:S644-8.

Blanton JD, Palmer D, Dyer J, Rupprecht CE. 2011. Rabies surveillance in the United States during 2010. 

J Am Vet Med Assoc 239:773-783. 

17
Brown, L.J., R.C. Rosatte, C. Fehlner-Gardiner, J.S. Taylor, J.C. Davies, and D. Donovan. 2012. 

Immune response and protection in raccoons (Procyon lotor) following consumption of baits 

containing ONRAB, a human adenovirus rabies glycoprotein recombinant vaccine. J. Wildl. Manage. 

48(4): 1010-1020.

CDC (Centers for Disease Control and Prevention), Lovelace Respiratory Research Institute, Mayo 

Clinic, and Wildlife Disease Association). 2011b. Proposed U.S. field trial of a recombinant human 

adenovirus – rabies vaccine (ONRAB): recommendations of a national working group to the U.S. 

Department of Agriculture, August 2011. CDC, 1600 Clifton Road, Atlanta, Georgia, 30333. 14pp.

CDC (Centers for Disease Control and Prevention). 2013. Human conflicts with oral rabies vaccine baits 

distributed for wildlife rabies management – Ohio, 2012. CDC – Morbidity and Mortality Weekly 

Report. Information obtained from website: 

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6214a3.htm?s_cid=mm6214a3_w

CFIA (Canadian Food Inspection Agency), Canadian Centre for Veterinary Biologics (CCVB). 2010. 

Environmental Assessment – Rabies vaccine, live adenovirus vector (AdRG1.3 baits) For field use in 

vaccination campaigns by the Ontario Ministry of Natural Resources. CCVB File No. 

900VV/R5.0/A22., 59 Camelot Drive, Ottawa, Ontario, K1A 0Y9.

CFIA (Canadian Food Inspection Agency), Canadian Centre for Veterinary Biologics (CCVB). 2008. 

Environmental Assessment – Rabies vaccine, live adenovirus vector (AdRG1.3 baits) For field use in 

field trials by le Ministère des resources naturelles et de la faune du Québec. CCVB File No. 

900VV/R5.0/A22, 2 Contellation Crescent, Ottawa, Ontario, K1A 0Y9.

Charleton, K.M., M. Artois, L. Prevec, J.B. Campbell, G.A. Casey, A.I. Wandeler, and J. Armstrong. 

1992. Oral rabies vaccination of skunks and foxes with a recombinant human adenovirus vaccine. 

Arch. Virol.; 123:169-179.

Fearneyhough MG, Wilson PJ, Clark KA, Smith DR, Johnston DH, Hicks BN, Moore GM. 1998. Results 

of an oral rabies vaccination program for coyotes. J Am Vet Med Assoc 212:498–502.

Fehlner-Gardiner, C., R. Rudd, D. Donovan, D. Slate, L. Kempf, and J. Badcock. 2012. Comparison of 

ONRAB and Raboral V-RG® oral rabies vaccine field performance in raccoons and striped skunks in 

New Brunswick, Canada, and Maine, U.S.A. Journal of Wildlife Diseases 48: 157-167.

Fry, T.L., K.K. VanDalen, C. Duncan, K, Vercauteren. 2013. The safety of ONRAB in select non-target 

wildlife. Manuscript submitted for publication.

Knowles, M.K., S.A. Nadin-Davis, M. Sheen, R. Rosatte, R. Mueller, and A. Beresford. 2009. Safety 

studies on an adenovirus recombinant vaccine for rabies (AdRG1.3 ONRAB) in target and non-target 

species. Vaccine; 27: 6619-6626.

Krebs, J.W., C.E. Rupprecht, and J.E. Childs. 2000. Rabies surveillance in the United States during 

1999. J. Amer. Vet. Med. Assoc. 217:1799-1811.

Krebs, J.W., T.W. Strine, J.S. Smith, C.E. Rupprecht, J.E. Childs. 1995. Rabies surveillance in the United 

18
States during 1994. J. Am. Vet. Med. Assoc. 207: 1562-1575

Lutze-Wallace, C., T. Sapp, M. Sidhu, A. Wandler. 1995a. In vitro assessments of the genetic stability of 

a live recombinant human adenovirus vaccine against rabies. Can. J. Vet. Res. 59:157-160.

Lutze-Wallace, C., A. Wandler, L. Prevec, M. Sidhu, T. Sapp, and J. Armstrong. 1995b. Characterization 

of a human adenovirus 5: rabies glycoprotein recombinant vaccine reisolated from orally vaccinated 

skunks. Biologics. 23:271-277.

Mainguy, J., C. Fehlner-Gardiner, D. Slate, and R. Rudd. 2013. Oral rabies vaccination in raccoons: 

comparison of ONRAB and RABORAL V-RG® vaccine-bait performance in Quebec, Canada and 

Vermont, USA. J. Wildl. Dis. 49(1): 190-193.

Prevec, L., J.B. Campbell, B.S. Chrisite, L. Belbeck, and F.L. Graham. 1990. A recombinant human 

adenovirus vaccine against rabies. J. Infect. Dis.; 161:27-30.

Ranrianarison-Jewtoukoff, V. and M. Perricaudet. 1995. Recombinant adenoviruses as vaccine. 

Biologicals; 23:145-157.

Rees EE, Bélanger D, Lelièvre F, Coté N, Lambert L. 2011.Targeted Surveillance of Raccoon Rabies in 

Québec, Canada. J Wildl Manage 75:1406-1416. 

Rosatte, R. C., D. Donovan, J.C. Davies, M. Allan, P. Bachmann, B. Stevenson, K. Sobey, L. Brown, A. 

Silver, K. Bennett, T. Buchanan, L. Bruce, M. Gibson, A. Beresford, A. Beath, C. Fehler-Gardiner, 

and K. Lawson. 2009. Aerial distribution of ONRAB baits as a tactic to control rabies in raccoons, 

and striped skunks in Ontario, Canada. J. Wildl. Dis.; 45(2): 363-374.

Rowe, W.P., R. Huebner, J. Hartley, T. Ward, and R. Parrot. 1955. Studies of the adenoidal-pharyngealconjuctival (APC) group of viruses. American Journal of Hygiene 61: 197-218.

Rupprecht, C.E., K.M/. Charlton, M. Artois, G.A. Casey, W.A. Webster, J.B. Campbell, K.F. Lawson, 

and L.G. Schneider. 1990. Ineffectiveness and comparative pathogenicity of attenuated rabies virus 

vaccine in striped skunk (Mephitis mephitis). Journal of Wildlife Diseases. 26: 99-102.

Rupprecht, C.E., B. Dietzchold, J.H. Cox, and L.G. Schiender. 1989. Oral vaccination of raccoons 

(Procyon lotor) with attenuated (SAD-B19) rabies virus vaccine. J of Wildlife Diseases. 25: 548-554.

Russell, W.C. 1998. Adenoviruses. In Toply and Wilson’s Microbiology and microbial infections, 9th

edition, L. Collier, A. Barows and M. Sussman (eds.). Edward Arnold, London, England, pp 281-290.

Sidwa TJ, Wilson PJ, Moore GM, Oertli EO, Hicks BN, Rohde RE, Johnston DH. 2005. Evaluation of 

oral rabies vaccination programs for control of rabies epizootics in coyotes and gray foxes. J. Am Vet 

Med Assoc 227:785–792.

Slate D, Algeo TP, Nelson KM, Chipman RB, Donovan D, Blanton JD, Niezgoda M, Rupprecht CE. 

2009. Oral Rabies Vaccination in North America: Opportunities, Complexities, and Challenges. PLoS 

Negl Trop Dis 3: e549.

19
Slate, D., C.E. Rupprecht, J.A. Rooney, D. Donovan, D.H. Lein, R.B. Chipman. 2005. Status of oral 

rabies vaccination in wild carnivores in the United States. Virus Research. 111: 68-76.

Tolson, N.D., K.M. Charlton, R.B. Stewart, J.B. Campbell, T.J. Wiktor. 1987. Immune response in 

skunks to a vaccinia virus recombinant expressing the rabies virus glycoprotein. Can. J. Vet. Res. 51: 

363-366.

USDA (U.S. Department of Agriculture), Forest Service (FS). 2013. Endangered, Threatened, and 

Sensitive Species, Monongahela national Forest – 2013. 200 Sycamore Street, Elkins, WV 26241.

USDA (U.S. Department of Agriculture), Animal and Plant health Inspection Service (APHIS), Wildlife 

Services. 2012. Environmental Assessment (EA) and decision/finding of no significant impact 

(FONSI) – Field trial of an experimental rabies vaccine, human adenovirus type 5 vector in New 

Hampshire, New York, Ohio, Vermont, and West Virginia. USDA, APHIS, Wildlife Services. 4700 

River Road, Unit 87, Riverdale, MD 20737-1234.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2012b. ONRAB (Human adenovirus serotype 5) oral rabies vaccine field trial report, West 

Virginia 2011. USDA, APHIS, Wildlife Services, National Rabies Management Program. 59 Chenell 

Dr., Suite 2, Concord, NH 03301.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Center 

for Veterinary Biologics. 2011a. Risk assessment for field testing rabies vaccine, live adenovirus 

vector. USDA-APHIS-CVB.

USDA (U.S. Department of Agriculture), Animal and Plant health Inspection Service (APHIS), Wildlife 

Services. 2011b. Environmental Assessment (EA) and decision/finding of no significant impact 

(FONSI) – Field trial of an experimental rabies vaccine, human adenovirus type 5 vector in West 

Virginia. USDA, APHIS, Wildlife Services. 4700 River Road, Unit 87, Riverdale, MD 20737-1234.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2011c. Monitoring Report-Calendar Year 2008-for Environmental Assessment – Oral 

vaccination to control specific rabies virus variants in raccoons, gray foxes, and coyotes in the United 

States. USDA, APHIS, Wildlife Services, 140-C Locust Grove Rd, Pittstown, NJ, 08867. 26p.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2010. Environmental Assessment (EA) and decision/finding of no significant impact 

(FONSI) - Oral vaccination to control specific rabies virus variants in raccoons, gray foxes, and 

coyotes in the United States. USDA, APHIS, Wildlife Services, 4700 River Road, Unit 87, Riverdale, 

MD 20737-1234.

U.S. Department of Agriculture. 2010b. Assessment of APHIS Wildlife Services’ National Rabies 

Management Plan. PAA-10-04. 51 pp.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2009. Monitoring Report-Calendar Year 2007-for Environmental Assessment – Oral 

20
vaccination to control specific rabies virus variants in raccoons, gray foxes, and coyotes in the United 

States. USDA, APHIS, Wildlife Services, 140-C Locust Grove Rd, Pittstown, NJ, 08867. 23p.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2008. Monitoring Report-Calendar Year 2006-for Environmental Assessment – Oral 

vaccination to control specific rabies virus variants in raccoons, gray foxes, and coyotes in the United 

States. USDA, APHIS, Wildlife Services, 140-C Locust Grove Rd, Pittstown, NJ, 08867. 23p.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2007. Monitoring Report-Calendar Year 2005-for Environmental Assessments Concerning 

the Management of Rabies in the United States. USDA, APHIS, Wildlife Services, 6213-E Angus 

Drive, Raleigh, NC 27617.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2007b. Decision/finding of no significant impact (FONSI) for environmental assessment 

oral vaccination to control specific rabies virus variants in raccoons, gray foxes, and coyotes in the 

United States. USDA, APHIS, Wildlife Services, 4700 River Road, Unit 87, Riverdale, MD 20737-

1234.

USDA (U.S. Department of Agriculture), Forest Service (FS). 2006. Monongahela National Forest Land 

and Resource Management Plan. USDA, FS, Elkins, WV 26241.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2005. Monitoring Report-Calendar Year 2004-for Environmental Assessments Concerning 

the Management of Rabies in the United States. USDA, APHIS, Wildlife Services, 6213-E Angus 

Drive, Raleigh, NC 27617. 

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2004a. Monitoring Report-Calendar Year 2003-for Environmental Assessment – Oral 

vaccination to control specific rabies virus variants in raccoons, gray foxes, and coyotes in the United 

States. USDA, APHIS, Wildlife Services, 6213-E Angus Drive, Raleigh, NC 27617. 22p.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2004c. Supplemental environmental assessment (EA) and decision/finding of no significant 

impact (FONSI) – Oral vaccination to control specific rabies virus variants in raccoons, gray foxes, 

and coyotes in the United States. USDA, APHIS, Wildlife Services, 4700 River Road, Unit 87, 

Riverdale, MD 20737-1234. 

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2003. Monitoring Report-Calendar Year 2001-for Environmental Assessments Concerning 

the Management of Rabies in the United States. USDA, APHIS, Wildlife Services, 6213-E Angus 

Drive, Raleigh, NC 27617. 

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2003b. Supplemental environmental assessment (EA) and decision/finding of no significant 

impact (FONSI) – Oral vaccination to control specific rabies virus variants in raccoons, gray foxes, 

21
and coyotes in the United States. USDA, APHIS, Wildlife Services, 4700 River Road, Unit 87, 

Riverdale, MD 20737-1234. 

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2002. Decision/finding of no significant impact (FONSI) for environmental assessment oral 

vaccination to control specific rabies virus variants in raccoons, gray foxes, and coyotes in the United 

States. USDA, APHIS, Wildlife Services, 4700 River Road, Unit 87, Riverdale, MD 20737-1234.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Wildlife 

Services. 2001a. Environmental Assessment (EA) and decision/finding of no significant impact 

(FONSI) - Oral vaccination to control specific rabies virus variants in raccoons, gray foxes, and 

coyotes in the United States. USDA, APHIS, Wildlife Services, 4700 River Road, Unit 87, Riverdale, 

MD 20737-1234.

USDA (U.S. Department of Agriculture), Animal and Plant Health Inspection Service (APHIS), Animal 

Damage Control Program. 1997. Final Environmental Impact Statement - revised October 1997. 

USDA, APHIS, Wildlife Services Operational Support Staff, 4700 River Road, Unit 87, Riverdale, 

MD 20737-1234.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2007. Environmental Assessment 

and Finding of No Significant Impact – Oral Rabies Vaccination Program, Palo Alto Battlefield 

National Historic Park, Texas. USDI/NPS. Intermountain Region, 12795 Alameda Parkway, Denver, 

CO 80225.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2005. Environmental Assessment 

and Finding of No Significant Impact - Oral Rabies Vaccination Program for Midwest Region Park 

Units, USDI/NPS, Midwest Region, 1709 Jackson St., Omaha, NE 68102.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2004a. Environmental Assessment 

and Finding of No Significant Impact – Oral Rabies Vaccination Program for Northeast Region 

Eastern Rivers and Mountains Park Units, USDI/NPS, Northern Region, 200 Chestnut St., Fifth 

Floor, Philadelphia, PA 19106.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2004b. Environmental Assessment 

and Finding of No Significant Impact – Oral Rabies Vaccination Program for Northeast Region 

Northern Coastal Barrier Network Park Units, USDI/NPS, Northern Region, 200 Chestnut St., Fifth 

Floor, Philadelphia, PA 19106.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2004c. Environmental Assessment 

and Finding of No Significant Impact – Oral Rabies Vaccination Program for Northeast Region 

Northern Temperate Network Park Units, USDI/NPS, Northern Region, 200 Chestnut St., Fifth Floor, 

Philadelphia, PA 19106.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2004 d. Environmental Assessment 

and Finding of No Significant Impact – Oral Rabies Vaccination Program for Northeast Region MidAtlantic Network Park Units, USDI/NPS, Northern Region, 200 Chestnut St., Fifth Floor, 

Philadelphia, PA 19106.

22
USDI (U.S. Department of the Interior), National Park Service (NPS). 2004e. Environmental Assessment 

and Finding of No Significant Impact - Oral Rabies Vaccination Program (on Southeast Region NPS 

units). USDI/NPS, Southeastern Region, 100 Alabama St. SW, 1924 Building, Atlanta, GA 30303.

USDI (U.S. Department of the Interior), National Park Service (NPS). 2003. Environmental Assessment 

and Finding of No Significant Impact - Oral Rabies Vaccination Program, Big Bend National Park, 

Guadalupe Mountains National Park, Amistad National Recreation Area, Texas. USDI/NPS, 

Intermountain Region, 12795 Alameda Parkway, Denver, CO 80225.

Velasco-Villa A, Reeder SA, Orciari LA, Yager PA, Franka R, Blanton JD, Zuckero L, Hunt P, Oertli 

EH, Robinson LE, Rupprecht CE. 2008. Enzootic rabies elimination from dogs and reemergence in 

wild terrestrial carnivores, United States. Emerg Inf Dis 14:1849–1854.

Wandeler, A.I. 1991. Oral immunization of wildlife. p. 485-505 in The natural history of rabies, 2nd ed., 

GM Baer, ed, CRC Press, Boca Raton, FL.

23
APPENDIX A

SPECIES LISTED AS THREATENED OR ENDANGERED 

UNDER THE ENDANGERED SPECIES ACT

Information obtained from http://ecos.fws.gov/tess_public/StateListing.do?state=all on April 2013. 

Listed species based on historic range and population data.

Ohio – 33 listings

Animals – 28

Status Listing

E Bat, Indiana (Myotis sodalis)

E Bean, rayed (Villosa fabalis)

E Beetle, American burying (Nicrophorus americanus)

E Butterfly, Karner blue (Lycaeides melissa samuelis)

E Butterfly, Mitchel’s satyr (Neonympha mitchellii mitchellii)

E Catspaw, white (pearlymussel) (Epioblasma obliquata perobliqua)

E Clubshell Entire Range; except where listed as Experimental Populations (Pleurobema 

clava)

E Curlew, Eskimo Enitre (Numenius borealis)

E Dragonfly, Hine’s emerald (Somatochlora hineana)

E Fanshell (Cyprogenia stegaria)

E Madtom, Scioto (Noturus trautmani)

E Mapleleaf, winged Entire; except where listed as experimental populations (Quadrula 

fragosa)

E Mucket, pink (pearlymussel) (Lampsilis abrupta)

E Mussel, scaleshell (Leptodea leptodon)

E Mussel, sheepnose (Plethobasus cyphyus)

E Mussel, snuffbox (Epioblasma triquetra)

E Pearlymussel, cracking Entire Range; except where listed as Experimental Populations 

(Hemistena lata)

E Pimpleback, orangefoot (pearlymussel) (Plethobasus cooperianus)

E Plover, piping Great Lakes watershed (Charadrius melodus)

T Plover, piping except Great Lakes watershed (Charadrius melodus)

E Pocketbook, fat (Potamilus capax)

E Puma (=cougar) eastern (Felis concolor cougar)

E Purple cat’s paw (=purple cat’s paw pearlymussel) Entire Range; Except where listed as 

Experimental Populations (Epioblasma obliquata obliquata)

E Riffleshell, northern (Epioblasma torulosa rangiana)

E Ring pink (mussel) (Obovaria retusa)

E Spectaclecase (mussel) (Cumberlandia monodonta)

T Snake, copperbelly water Indiana north of 40 degrees north latitude, Michigan, Ohio 

(Nerodia erythrogaster neglecta)

E Wolf, gray Lower 48 States, except MN, MT, ID, portions of eastern OR, eastern WA, 

north-central UT, and where EXPN. Mexico (canis lupus)

24
Plants – 5

Status Listing

E Clover, running buffalo (Trifolium stoloniferum)

T Daisy, lakeside (Hymenoxys herbacea)

T Monkshood, northern wild (Aconitum noveboracense)

T Orchid, eastern prairie fringed (Platanthera leucophaea)

T Spirea, Virginia (Spirea virginiana)

New Hampshire – 15 listings

Animals – 12

Status Listing

E Beetle, American burying (Nicrophorus americanus)

E Butterfly, Karner blue (Lycaeides melissa samuelis)

E Caibou, woodland Selkirk Mountain population (Rangifer tarandus caribou)

E Curlew, Eskimo Enitre (Numenius borealis)

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis)

T Plover, piping except Great Lakes watershed (Charadrius melodus)

E Puma (=cougar) eastern (Felis concolor cougar)

E Sea turtle, leatherback (Dermochelys coriacae)

T Tiger bettle, Puritan (Cicindela puritan)

E Wedgemussel, dwarf (Alasmidinta heterodon)

E Whale, finback (balaenoptera physalus)

E Wolf, gray U.S.A.: All of AL, Ar, CA, CO, CT, DE, FL, GA, KS, KY, LA, MA, MD, 

ME, MO, MS, NC, NE, NH, NJ, NV, NY, OK, PA, RI, SC, TN, VA, VT, and WV; those 

portions of AZ, NM, and TX not included in an experimental population; and portions of 

IA, IN, IL, ND, OH, OR, SD, UT, and WA. Mexico. (Canus lupus)

Plants – 3

Status Listing

E Bulrush, Northeastern (Scirpus ancistrochaetus)

E Milk-vetch, Jesop’s (Astragalus robbinsii var. jesupi)

T Pogonia, small whorled (Isotria medeoloides)

New York – 33 Listings

Animals – 23

Status Listing 

E Bat, Indiana (Myotis sodalis)

E Bean, rayed (Villosa fabalis)

E Beetle, American burying (Nicrophorus americanus)

E Butterfly, Karner blue (Lycaeides melissa samuelis)

25
E Curlew, Eskimo Enitre (Numenius borealis)

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis)

T Plover, piping except Great Lakes watershed (Charadrius melodus)

E Plover, piping Great Lakes watershed (Charadrius melodus)

E Puma (=cougar) eastern (Felis concolor cougar)

T Sea turtle, green except where endangered (Chelonia mydas)

E Sea turtle, hawksbill (Eretmochelys imbricate)

E Sea turtle, Kemp’s ridley (Lepidochelys coriacea)

E Sea turtle, leatherback (Dermochelys coriacae)

T Snail, Chittenango ovate amber (Succinea chittenangoensis)

E Sturgeon, shortnose (Acipenser brevirostrum)

E Tern, roseate northeast U.S. nesting pop. (Sterna dougallii dougallii)

T Tiger bettle, northeastern beach (Cicindela dorsalis dorsalis)

T Turtle, bog (=Muhlenberg) northern (Clemmys muhlenbergii)

E Wedgemussel, dwarf (Alasmidinta heterodon)

E Whale, finback (balaenoptera physalus)

E Whale, humpback (Megaptera novaengliae)

E Whale, North Atlantic Right (Eubalaena glacialis)

E Wolf, gray Lower 48 States, except MN, MT, ID, portions of eastern OR, eastern WA, 

north-central UT, and where EXPN. Mexico. (Canus lupus)

Plants – 10

Status Listing

T Amaranth, seabeach (Amaranthus pumilus)

E Bulrush, Northeastern (Scirpus ancistrochaetus)

E Chaffseed, American (Schwalbea Americana)

T Fern, American hart’s tongue (Asplenium scolopendrium var.)

E Gerardia sandplain (Agalinis acuta)

T Monkshood, northern wild (Aconitum noveboracense)

T Orchid, eastern prairie fringed (Platanthera leucophaea)

T Pink, swamp (Helonias bullata)

T Pogonia, small whorled (Isotria medeoloides)

T roseroot, Leddy’s (Rhodiola integrifolia ssp. leedyi)

Vermont – 12 Listings

Animals – 9

Status Listing

E Bat, Indiana (Myotis sodalis)

E Beetle, American burying (Nicrophorus americanus)

E Caibou, woodland Selkirk Mountain population (Rangifer tarandus caribou)

E Curlew, Eskimo Enitre (Numenius borealis)

T Lynx, Canada (Contiguous U.S. DPS) (Lynx canadensis)

E Puma (=cougar) eastern (Felis concolor cougar)

E Wedgemussel, dwarf (Alasmidinta heterodon)

26
T Tiger bettle, northeastern beach (Cicindela dorsalis dorsalis)

E Wolf, gray Lower 48 States, except MN, MT, ID, portions of eastern OR, eastern WA, 

north-central UT, and where EXPN. Mexico. (Canus lupus)

Plants – 3

Status Listing

E Bulrush, Northeastern (Scirpus ancistrochaetus)

E Milk-vetch, Jesop’s (Astragalus robbinsii var. jesupi)

T Pogonia, small whorled (Isotria medeoloides)

West Virginia – 26 listings

Animals – 20 

Status Listing

E Bat, Indiana (Myotis sodalis)

E Bat, gray (Myotis grisescens)

E Bat, Virginia big-eared (Plecotus townsendii virginianus)

E Bean, rayed (Villosa fabalis)

E Beetle, American burying (Nicrophorus americanus)

E Blossum, tubercled (pearlymussel) Entire Range; Except where listed as Experimental 

Populations (Epioblasma torulosa torulosa)

E Clubshell Entire Range; except where listed as Experimental Populations (Pleurobema 

clava)

E Curlew, Eskimo Enitre (Numenius borealis)

E Fanshell (Cyprogenia stegaria)

E Mucket, pink (pearlymussel) (Lampsilis abrupta)

E Mussel, sheepnose (Plethobasus cyphyus)

E Mussel, snuffbox (Epioblasma triquetra)

E Puma (=cougar) eastern (Felis concolor cougar)

E Riffleshell, northern (Epioblasma torulosa rangiana)

E Ring pink (mussel) (Obovaria retusa)

T Salamander, Cheat Mountain (Plethodon netting)

T Snail, flat-spired three-toothed (Triodopsis platysayoides)

E Spectaclecase (mussel) (Cumberlandia monodonta)

E Spinymussel, James (Pleurobema collina)

E Wolf, gray Lower 48 States, except MN, MT, iD, portions of eastern OR, eastern WA, 

north-central UT, and where EXPN. Mexico. (Canus lupus)

Plants – 6

Status Listing

E Bulrush, Northeastern (Scriptus ancistrochaetus)

E Clover, running buffalo (Trifolium stoloniferum)

E Harperella (Ptilimnium nodosum)

T Pogonia, small whorled (Isotria medeoloides)

E Rock-cress, shale barren (Arabis serotina)

27
T Spirea, Virginia (Spirea virginiana)

E=Endangered, T=Threatened

28
APPENDIX B

SUMMARY OF SPECIES LISTED AS THREATENED, ENDANGERED, OR SPECIAL STATUS

UNDER STATE LAW IN STATES PROPOSED FOR APHIS-WS INVOLVEMENT IN 

CONTINUED OR EXPANDED ONRAB® FIELD TRIALS 

Number of State Listed Species by Category

(Species for which concerns about ORV programs might be raised are identified and shown in bold)

Information obtained from http://www.fws.gov/offices/statelinks.html on April 2013.

State Mammals Birds Reptiles Amphibians Fish Invertebrates Plants

New 

Hampshire

4E, 1T

Canada lynx, American 

marten, New England 

Cottontail, gray wolf

8E, 7T 3E, 2T 1E 2 E, 1T 9E, 2T 316E, 

81T

New York 10E, 1T, 3SC

Canada lynx, New England 

cottontail, gray wolf, 

Eastern puma

10E, 

10T, 

19SC

7E, 5T, 

6SC

2E, 7SC 8E, 

11T, 

5SC

16E, 8T, 18SC 331E, 

135T, 

11R

Ohio 4E, 2T, 19SC, 1SI

bobcat, snowshoe hare, 

American black bear, 

ermine, American badger

14E, 

5T, 14 

SC, 

33SI

4E, 4T, 

11SC

5E, 1T, 2SC 20E, 

13T, 

9SC

73E, 29T, 

48SC, 12SI

242E, 

162T, 

113P

Vermont 7E, 1T

Canada lynx, Eastern 

mountain lion, American 

marten

9E, 2T 3E, 3T 1E 4E, 2T 8E, 6T 65E, 

93T

West 

Virginia

6S1, 10S2, 4S3

West Virginia northern 

flying squirrel, eastern 

spotted skunk, 

Appalachian cottontail

26S1, 

16S2, 

13S3

5S1, 

11S2, 3S3

5S1, 6S2, 5S3 35S1, 

21S2, 

10S3

185S1, 76S2, 

53S3

248S1, 

150S2, 

43S3

E=State Endangered; T=State Threatened; SC=Species of Concern; SI=Species of Interest; R=Rare; P=Potentially Threatened; 

S1, S2, and S3=WV designations for levels of concern.

State T&E Protections under State Law

New Hampshire With respect to any endangered or threatened species, it is unlawful to: (a) Export 

any such species from this state; (b) Take any such species within this state; (c) 

Possess, process, sell, or offer for sale, deliver, carry, transport, or ship, by any 

means whatsoever, any such species; (d) Violate any rule adopted under this 

chapter pertaining to the conservation of such species of wildlife listed pursuant to 

RSA 212-A:6, IV

New York Endangered and threatened categories have protections against “take”; “special 

concern” category has no special additional protection.

Ohio Unlawful to “take” and endangered species of fish or wildlife; “take” not 

specifically defined; no exemptions or permits to allow for incidental take; no 

special protections for “threatened” or “special interest” species; APHIS-WS 

advised to just release any state listed species if captured or to report accidental 

mortality.

Vermont Unlawful to “take” any endangered or threatened species without the issuance of a 

permit; “take” not specifically defined; state law includes all federally listed 

species as state listed.

West Virginia Only lists federal T&E species as having protections; “Species of Concern” are 

listed, but have no legal status other than that are already federally listed.

29
APPENDIX C

REGIONAL FORESTER SENSITIVE SPECIES

for the

MONONGAHELA NATIONAL FOREST (USDA 2013)

Federally Listed Species

Gray wolf Canis lupus Considered Extirpated

Eastern cougar Puma concolor couguar Considered Extirpated

Virginia big-eared bat Corynorlinus townsendii virginianus Endangered

Indiana bat Myotis sodalist Endangered

Cheat Mountain salamander Plethodon netting Threatened

Regional Forester Sensitive Species

Mammals

WV Northern flying squirrel Glaucomys sabrinus fuscus

Southern rock vole Microtus chrotorrhinus carolinensis

Eastern small-footed bat Myotis leibii

Little brown myotis Myotis lucifugus

Northern myotis Myotis septentrionalis

Allegheny woodrat Neotoma magister

Tri-colored bat Perimyotis subflavus

Long-tailed or rock shrew Sorex dispar

Southern water shrew Sorex palustris punctulatus

Eastern spotted skunk Spilogale putoris

Southern bog lemming Synaptomys cooperi

Birds

Northern goshawk Accipiter gentilis

Henslow’s sparrow Ammodramus henslowii

Long-eared owl Asio otus

Olive-sided flycatcher Contopus cooperi

American Peregrine falcon Flaco peregrines anatum

Bald eagle Haliaeetus leucocephalus

Migrant loggerhead shrike Lanius ludovicianus migrans

Red-headed woodpecker Melanerpes erythrocephalus

Vesper sparrow Pooecetes gramineus

Golden-winged warbler Vermivora chrysoptera

Reptiles and Amphibians

Wood turtle Glyptemys insculpta

Timber rattlesnake Crotalus horridus

Green salamander Aneides aeneus

30
Eastern hellbender Cryptobrachus alleghaniensis

Mud salamander Pseudotriton montanus

Fish and Mollusks

Redside dace Clinostomus elongatus

Candy darter Etheostoma osburni

Pearl dace Margariscus margarita

New River shiner Notropis scabriceps

Cheat minnow Pararhinichthys bowersi

Appalachia darter Percina gymnocephala

Kanawha minnow Phenacobious teretulus

Elktoe Alasmindonta marginata

Green floater Lasmigona subviridis

Organ cavesnail Fontigens tartarea

Insects and Invertebrates

Boreal fan moth Brachionycha borealis

Northern metalmark Calephelis borealis

Appalachian tiger beetle Cicindela ancocisconensis

Northern Barrens tiger beetle Cicindela patruela

Cow path tiger beetle Cicindela purpurea

Early hairstreak Erora laeta

Columbine duskywing Erynnis lucillius

A geometrid moth Euchlaena milnei

Rapids clubtail Gomphus quadricolor

Green-faced clubtail Gomphus viridifrons

A noctuid moth Hadena ectypa

Cobweb skipper Hesperia metea

Bronze Copper Lycaena hyllus

West Virginia white Pieris virginiensis

A cave beetle Pseudanophthalmus fuscus

Timber Ridge cave beetle Pseudanophthalmus hadenoecus

A cave beetle Pseudanophthalmus hypertrichosis

Dry Fork valley cave beetle Pseudanophthalmus montanus

Gandy Creek cave springtail Pseudosinella certa

A springtail Pseudosinella gisini

Southern grizzled skipper Pyrgus wyandot

A springtail Sinella agna

Diana fritillary Speyeria Diana

Dry Fork Valley cave pseudoscorpion Apochthonius paucispinosus

Cheat Valley cave isopod Caecidotea cannula

Greenbrier Valley cave isopod Caecidotea holsingeri

An isopod Caecidotea simonini

An isopod Caecidotea sinuncus

Elk River crayfish Cambarus elkensis

An underground crayfish Cambarus nerterius

Culver’s cave isopod Stygobromus culveri

Greenbrier cave amphipod Stygobromus emarginatus

31
Pocahontas cave amphipod Stygobromus nanus

Minute cave amphipod Stygobromus parvus

Hoffmaster’s cave flatworm Macrocotyla hoffmasteri

A cave obligate planarian Phagocata angusta

Greenbrier Valley cave millipede Pseudotremia fulgida

Germany Valley cave millipede Pseudotremia lusciosa

South Branch Valley cave millipede Pseudotremia princeps

Culver’s planarium Sphalloplana culveri

Grand Caverns blind cave millipede Trichopetalum weyeriensis

Luray Caverns blind cave millipede Trichopetalum whitei

WV blind cave millipede Trichopetalum krekeleri

32
APPENDIX D

ONRAB FIELD TRIAL STUDY PROTOCOLS

Outline for Proposed ONRAB Oral Rabies Vaccine Field Trial in Northern New Hampshire, 

Northeastern New York and Northern Vermont in 2013

PRIMARY GOALS: Determine if ONRAB baiting at 75 baits/km2 during a second consecutive year of 

field trials over an area in northern New Hampshire, northeastern New York and northern Vermont and 

that has been baited at the same bait density with Raboral V-RG® since the late 1990’s would result in a 

significant increase in sero-prevalence in 2013. Determine the sero-prevalence of baiting with ONRAB 

for a second time in a previously ORV naïve rural area in New York, Vermont and New Hampshire and 

evaluate these results in the context of the same baiting protocol used in rural West Virginia in 2011-

2012. Determine if ONRAB baiting at 75 baits/km2 or 150 baits/km2 over an area that has been baited at 

the same densities with Raboral V-RG® since the late 1990’s in the St. Lawrence region of New York 

would result in a significant increase in sero-prevalence in 2013.

1) SITE LOCATION (Figure 1)

 States: New Hampshire, New York and Vermont

 Counties: 

o New Hampshire: Coos, Grafton

o New York: Clinton, Essex, St. Lawrence, Jefferson

o Vermont: Addison, Essex, Franklin, Grand Isle, Orleans, Lamoille, Caledonia, 

Chittenden, Washington 

 Towns with some ground baiting: 

o New Hampshire: Colebrook, Lancaster 

o New York: Alexandria Bay, Altona, Brasher Falls, Canton, Cape Vincent, Chazy, 

Clayton, Massena, Moors, Norfolk, Norwood, Ogdensburg, Plattsburgh, Potsdam, Rouses 

Point, Winthrop 

o Vermont: Burlington, Derby Center, Derby Line, Enosburg, Jericho, Lyndonville, Milton, 

Newport, North Troy, Richford, St. Albans, St. Johnsbury, Swanton, Waterville

2) RATIONALE FOR FIELD TRIAL SITE SELECTION

 North American Rabies Management Plan collaboration in a high risk corridor for raccoon rabies 

to spread from the U.S. back into Quebec and Ontario

 Raccoons and skunks present

 Raccoon rabies present in the U.S. but no cases in Quebec since July 2009 and in Ontario since 

September 2005

 Local support within state and county and the Provinces of Quebec and Ontario

 WS infrastructure in place 

33
3) FIELD TRIAL PLOT SIZE

 Total ONRAB ORV zone: 13,482.71 km2 including 366.41 km2 ground baiting

 10 distance buffered 126.84 km2

cells (11.2 x 11.2 km) for pre and post-ORV sampling 

4) BAITING CHARACTERISTICS

 Total ONRAB baits: 864,900 (838,800 fixed wing and 26,100 ground)

 Bait density: 75/150 baits/km2 (75 baits/km2 in all sampling cells)

 Approximately 14,000 ONRABbaits/sampling cell

 Flight line spacing: 375/750 meters (750 meters in all sampling cells)

 Overall Off-time: 29.5% average for fixed wing and 25% average for ground using NLCD to 

determine “baitable” habitat

 Projected baiting dates: August 20-26, 2013

 Baiting duration: 5 days, 5 planes and ground crews for hand-baiting

5) BAIT-VACCINE CHARACTERISTICS

 Each bait contains 1.8 ± 0.1ml of ONRAB vaccine (titer of not < 109.5 cell culture infectious dose 

50% [CCID50]/ml)

 Bait matrix is comprised of partially hydrogenated vegetable shortening (34%), Microbond wax 

(30%), stearine (12.5%), Icing sugar (20%), vegetable oil (1%), artificial marshmallow flavor 

(1%), artificial sweet flavor (1%), and a fat-soluble food dye (0.5%)

 Bait matrix contains 100 mg of tetracycline hydrochloride as a biomarker

 Each vaccine-bait weighs approximately 4g

 The body of the blister pack is an elongated oval with dimensions of 30x14x10mm (1.81 x 0.55 x 

0.39in) 

 Each bait contains a conspicuous advisory label with a toll free number in the event of a bait 

contact and potential vaccine exposure 

6) PRE-ORV SAMPLING (BASELINES) AND ACTIVITIES

 Enhanced rabies surveillance has been in place for more than 1 year

 In late summer 2013, 150 raccoon-sized cage traps will be tended for 10 consecutive days within 

each of the 10 sampling cells (4 historically ORV naïve cells, but baited with ONRAB in 2012 

and 6 cells historically baited at 75 baits/km2 with Raboral V-RG® but baited with ONRAB in 

2012)

 Traps will be deployed within half a mile (800 meters) of predetermined random trapping 

locations

 Expect capture rate of ~100 raccoons/cell based on recent previous trapping efforts in area

 Attempt to maximize skunk captures by additional targeted trapping if practical

 From raccoons and skunks: collect pertinent biological, physical and spatial-temporal data; sera 

for rabies serological analysis (at least 2 vials per animal if practical); first premolar teeth for age 

determination and biomarker analysis; mark and release at site of capture

34
 Euthanize target species with unusual lesions or behaviors for analysis

 Opportunistic sampling for additional target and nontarget species (e.g., roadkills or live animals) 

that display abnormal behavior or have lesions that should be evaluated

 Use various media outlets to advise the public when and where baiting will occur and 

precautions to be followed to reduce chance of vaccine exposure

7) POST-ORV SAMPLING (TREATMENT EFFECTS) AND ACTIVITIES

 Continue enhanced rabies surveillance

 Continue opportunistic sampling for target and nontarget species (e.g., roadkills, hunter harvest) 

that display abnormal behavior or have lesions that should be evaluated for pathological context

 5 weeks post ORV sample ~100 raccoons and as many skunks as practical within each of the 10 

sampling cells using the pre-ORV target species trapping protocol 

 Collect pertinent biological, physical and spatial-temporal data from raccoons and skunks as well 

as sera for rabies serological analysis (at least 2 vials per animal if practical), and first premolar 

teeth for age determination and biomarker analysis

 Use acceptable algorithm with appropriate public health, agriculture and wildlife officials to 

ensure bait contacts are received through a legible, toll-free phone number on each bait or other 

sources are reported and addressed by the proper expertise (e.g., Vermont Rabies Hotline)

8) SAMPLE ANALYSIS 

 Rabies virus titers to be determined by Wadsworth Laboratory, New York State Department of 

Health, Albany, NY

 Specific age determination and biomarker detection by Matson’s Laboratory, Milltown, MT

9) REPORT FINDINGS

 Expect results from analysis of field data by April 2014 

 Draft report by June 2014

35
Figure 1. Baiting plan for the northern New Hampshire, northeastern New York and northern Vermont 

ONRAB field trial in 2013, including ten sampling cells.

36
Outline for Proposed ONRAB Oral Rabies Vaccine Field Trial in Western New York in 2013 –

Collaboration with Cornell University

PRIMARY GOALS - To determine if ONRAB deployment at a target density of 75 baits/km2 will effect a 

greater proportion of seropositive raccoons, when compared to 14 years of historical Raboral V-RG® data 

(Table 1) from the same oral rabies vaccination (ORV) zone (1995-2012). To evaluate a potential 

contingency response strategy (CRS) incorporating a greater ONRAB distribution density of 150 

baits/km2

. The proposed ONRAB field trial planned for the Buffalo/Niagara region of western New York 

is a collaborative effort led by Cornell University in cooperation with USDA, APHIS, Wildlife Services. 

Cornell University will serve as the lead investigating organization for this study, will purchase ONRAB 

baits, distribute ground baits in residential areas, and will conduct all pre- and post-ORV sampling and 

activities. Wildlife Services will purchase Raboral V-RG® baits, provide aviation support, and distribute 

all ORV baits (both ONRAB and V-RG) designated for fixed-wing and helicopter bait distribution. 

1) SITE LOCATION

 State: New York

 Counties: Erie, Niagara (Figure 2)

 Towns within ONRAB zone

Residential: Lockport, Niagara Falls, North Tonawanda, Grand Island, Tonawanda, Amherst, 

Buffalo, Lackawana (part), Cheektowaga (part), Clarence (part), West Seneca (part)

Rural: Porter, Wilson, Newfane, Somerset, Hartland, Lockport, Cambria, Lewiston, Niagara, 

Pendleton, Wheatfield, Royalton, Amherst (part), Clarence (part), Newstead (part), Tuscarora 

Nation, Tonawanda Nation (part)

2) RATIONALE FOR FIELD TRIAL SITE SELECTION

 Terrestrial rabies cases have consistently been confirmed in target and nontarget (i.e., domestic 

and wild) mammals since ORV was initiated during 1995 (Niagara County) and 2002 (Erie 

County)

 The epizootic front has remained static since 1995; however, the North American Rabies 

Management Plan identifies Western NY as a high-risk corridor for spread of the raccoon variant 

of rabies virus to Ontario, Canada

 Cornell infrastructure in place

 State funding provided for ONRAB 2013 trial

 Ontario funding for ONRAB 2013 trial anticipated

 In-kind support provided by federal, state, county and provincial sources

 Raccoons and skunks are present

3) FIELD TRIAL PLOT SIZE

 Total ONRAB ORV zone: 1902.7 km2 including 575.8 km2 of residential habitats

4) BAITING CHARACTERISTICS

37
 Methods of bait distribution

Rural: Fixed-wing aircraft

Residential: Helicopter and bait station

 Total ONRAB baits: 177,247 

Rural: 94,309 

Residential: 82,938

 Bait density: 75 and 150 baits/km2

 Flight line spacing: 

Rural: 750 meters

Residential: 500 meters

 Average Off-time: 

Rural: 32%

Residential: 0%

 Projected ORV Distribution: Late August 2013

 Baiting duration: 2 weeks

5) BAIT-VACCINE CHARACTERISTICS

 Each bait contains 1.8 ± 0.1ml of ONRAB vaccine (titer not less than 109.5 cell culture infectious 

dose 50% [TCID50]/ml)

 Bait matrix comprised of partially hydrogenated vegetable shortening (34%), Microbond wax 

(30%), stearine (12.5%), Icing sugar (20%), vegetable oil (1%), artificial marshmallow flavor 

(1%), artificial sweet flavor (1%), and a fat-soluble food dye (0.5%)

 Bait matrix contains 100 mg of tetracycline hydrochloride as a biomarker

 Each vaccine-bait weighs approximately 4g

 The body of the blister pack is an elongated oval with dimensions of 30x14x10mm 

(1.81 x 0.55 x 0.39 in) 

 Each bait contains a conspicuous advisory label with a toll free number in the event of a bait 

contact and potential vaccine exposure 

6) PRE-ORV SAMPLING AND ACTIVITIES

 Enhanced rabies surveillance

 Number live-trapping cells: 3

 Target collection of 100 raccoons from each cell

 Record biological, physical and spatiotemporal data; aspirate blood for virus neutralization assay; 

extract first-premolar tooth for age determination and biomarker analyses; ear-tag and release at 

capture site

 Ancillary data and samples will be collected from skunks

 Animals exhibiting unusual lesions or behaviors will be euthanized for subsequent testing

 Three public meetings within the ONRAB zone will be scheduled; local agencies, furbearer 

hunting and trapping groups will be notified; additional media outreach will be exploited to 

38
provide health professionals, veterinarians, and the public with information relative to ORV 

details

7) POST-ORV SAMPLING AND ACTIVITIES

 Continue enhanced rabies surveillance within ORV zone

 Continue opportunistic sampling for target and non-target species (e.g., roadkills, hunter harvest) 

that display abnormal behavior or exhibit lesions that should be evaluated for pathological 

context

 Live-trap 100 raccoons/cell and as many skunks as practical 

 Record biological, physical and spatiotemporal data; aspirate blood for virus neutralization assay; 

extract first-premolar tooth for age determination and biomarker analyses; ear-tag and release at 

capture site

 Use USDA bait contact procedures in cooperation with local and state officials to ensure that bait 

contacts are received through a legible, toll-free phone number

8) SAMPLE ANALYSES 

 Rabies virus neutralization assay performed at Wadsworth Center, New York State Department 

of Health Rabies Laboratory, Albany, NY

 Age determination and biomarker analyses performed by Matson’s Laboratory, Milltown, MT

9) REPORT FINDINGS

 Expect results from analysis of field data by April 2014

 Draft report by May 2014

39
Figure 2. Proposed ONRAB field trial and Raboral V-RG® ORV Zones in Western NY in 2013.

40
Outline for Proposed ONRAB Oral Rabies Vaccine Field Trial in Northeast Ohio in 2013

PRIMARY GOALS: Determine if ground distribution of ONRAB at 150 baits/km2 during a second 

consecutive year of field trials would result in significantly higher sero-prevalence in an area that has 

often been subjected to twice/year and high density baiting (150 baits/km2

) with Raboral V-RG® and trapvaccine-release. A primary focus will be on the ORV and TVR naïve juvenile cohort. Raboral V-RG®

ground cells will be included in this field trial for comparative context.

1) SITE LOCATION (Figure 3)

 State: Ohio

 Counties: portions of Cuyahoga, Geauga, Lake, Portage and Summit

 Towns: Aurora, Beachwood, Bedford, Bedford Heights, Bentleyville Chagrin Falls, Boston 

Heights, Burton, Chardon, Cleveland, Cleveland Heights, Cleveland Metro Parks, Concord, East 

Cleveland, Eastlake, Euclid, Garfield Heights, Gates Mills, Glenwillow, Highland Heights, 

Highland Hills, Hudson, Hunting Valley, Independence, Kirkland, Kirkland Hills, Lyndhurst, 

Macedonia, Madison, Maple Heights, Mayfield, Mayfield Heights, Mentor, Mentor on the Lake, 

Middlefield, Moreland Hills, North Randall, Northfield, Northfield Center, Oakwood, Orange, 

Painesville, Pepper Pike, Perry, Reminderville, Richmond Heights, Sagamore Hills, Shaker 

Heights, Solon, South Euclid, South Russell, Twinsburg, University Heights, Valley View, 

Waite Hills, Warrensville Heights, Wickliffe, Willoughby, Willoughby Hills, Willowick, 

Woodmere

2) RATIONALE FOR FIELD TRIAL SITE SELECTION

 The area has been intensively managed since 2007 through contingency actions (high density 

baiting at 150 baits/km2

, often twice/year baiting over much of the area, and TVR) because it 

continues to represent a high risk corridor for raccoon rabies spread to the West

 Selection was based partially on the need for improved ORV performance and the ability to 

evaluate high density ground baiting, a commonly used ORV tactic in urban-suburban settings

 All Ohio field trial cells will be ground baited at 150 baits/km2 of the baitable habitat

 Raccoons and skunks present

 Raccoon rabies present east of existing area and detected in skunks within the ORV zone

 Continued local support within state and county

 WS infrastructure in place

3) FIELD TRIAL PLOT SIZE

 Total area: 2,434.36 km2 including 1,123.67 km2 ground and helicopter baiting 

 24 ONRABand 12 Raboral V-RG® 1 km2 cells (1 x 1 km) will be selected from 30 and 32 

available cells, respectively for pre and post-ORV sampling

4) BAITING CHARACTERISTICS

41
 Total ONRAB baits: 269,100 (144,000 fixed wing and 125,100 ground and helicopter) 

 Bait density: 150 baits/km2

 Total Raboral V-RG® baits: 45,720 (ground, helicopter and fixed wing distributed)

 Approximately 116 ONRAB or Raboral V-RG® baits will be distributed by hand/1km2 sampling 

cell

 Flight line spacing: 375 meters 

 Off-time: 33% for fixed wing and an average of 23% for ground and helicopter using National 

Land Class Dataset to determine “baitable” habitat 

 Projected baiting dates: August 28-September 1, 2013

 Baiting duration: 4 days, 3 planes, 1 helicopter and ground crews for hand-baiting

5) BAIT-VACCINE CHARACTERISTICS

 Each bait contains 1.8 ± 0.1ml of ONRAB vaccine (titer of not < 109.5 cell culture infectious dose 

50% [CCID50]/ml)

 Bait matrix is comprised of partially hydrogenated vegetable shortening (34%), Microbond wax 

(30%), stearine (12.5%), Icing sugar (20%), vegetable oil (1%), artificial marshmallow flavor 

(1%), artificial sweet flavor (1%), and a fat-soluble food dye (0.5%)

 Bait matrix contains 100 mg of tetracycline hydrochloride as a biomarker

 Each vaccine-bait weighs approximately 4g

 The body of the blister pack is an elongated oval with dimensions of 30x14x10mm

(1.81 x 0.55 x 0.39in) 

 Each bait contains a conspicuous advisory label with a toll free number in the event of a bait 

contact and potential vaccine exposure 

6) PRE-ORV SAMPLING (BASELINES) AND ACTIVITIES

 Enhanced rabies surveillance has been in place since 2004, with no raccoon rabies variant cases 

detected in 2013 (including as spillover in skunks) in the study area to date

 In late summer 2013, 25 raccoon-sized cage traps will be tended for 10 consecutive days within 

each of the 36 sampling cells (24 ONRAB and 12 Raboral V-RG®)

 Traps will be deployed based on past trapping trends to ensure adequate property access in this 

highly residential and commercial landscape

 Target for juvenile captures is 12 raccoons/cell as young of the year represent the only ORV 

naïve cohort in the sample; maximize recaptures

 Maximize skunk captures by additional targeted trapping where practical

 From raccoons and skunks: collect pertinent biological, physical and spatial-temporal data; sera 

for rabies serological analysis (at least 2 vials per animal if practical); first premolar teeth for age 

determination and biomarker analysis; mark and release at site of capture

 Euthanize target species with unusual lesions or behaviors for analysis

 Opportunistic sampling for additional target and nontarget species (e.g., roadkills or live animals) 

that display abnormal behavior or have lesions that should be evaluated

42
 Use various media outlets to advise the public when and where baiting will occur and 

precautions to be followed to reduce chance of vaccine exposure

7) POST-ORV SAMPLING (TREATMENT EFFECTS) AND ACTIVITIES

 Continue enhanced rabies surveillance

 Continue opportunistic sampling for target and nontarget species (e.g., roadkills, hunter harvest) 

that display abnormal behavior or have lesions that should be evaluated

 5 weeks post-ORV sample at least 30 raccoons/cell and as many skunks as practical within each 

of the 36 sampling cells using the pre-ORV target species trapping protocol

 Collect pertinent biological, physical and spatial-temporal data from raccoons and skunks as well 

as sera for rabies serological analysis (at least 2 vials per animal if practical) and first premolar 

teeth for age determination and biomarker analysis

 Use acceptable algorithm with appropriate public health, agriculture and wildlife officials to 

ensure bait contacts are reported through a legible, toll-free phone number on each bait or other 

sources and addressed by the proper expertise

8) SAMPLE ANALYSIS 

 Rabies virus titers to be determined by CDC or GARC, Atlanta, GA

 Specific age determination and biomarker detection by Matson’s Laboratory, Milltown, MT

9) REPORT FINDINGS

 Expect results from analysis of field data by April 2014 

 Draft report by June 2014

43
Figure 3. Baiting plan for the Ohio ONRAB field trials in 2013, including locations of ONRAB and 

Raboral V-RG® 1 km2 sampling cells.

44
Outline for Proposed Replicate of ONRAB Oral Rabies Vaccine Field Trial in Southeastern West 

Virginia in 2013

PRIMARY GOALS: Determine if replication of the 2011 and 2012 West Virginia ONRAB trials through a 

third annual ORV campaign at 75 baits/km2 would result in significantly increased sero-prevalence in 

2013. Compare ONRABto Raboral V-RG® sero-prevalence in 2013. Sero-prevalence would be derived 

from sampling cells in established Raboral V-RG® ORV zones in West Virginia since 2001 that have 

been baited annually at 75 baits/km2

.

1) SITE LOCATION (Figure 4)

 State: West Virginia 

 Counties: Fayette, Greenbrier, Mercer, Monroe, Pocahontas, Raleigh, Summers 

 Towns: Alderson, Fairlea, Falling Springs, Hinton, Lewisburg, Ronceverte

2) RATIONALE FOR FIELD TRIAL SITE SELECTION

 Site of first and second field trials with ONRAB in 2011 and 2012, allowing for replication to 

evaluate sero-prevalence after a third year of ONRAB baiting in 2013

 Ability to add two sampling cells in the adjacent historic Raboral V-RG® zone in West Virginia 

to facilitate a more formal comparison 

 In 2011, post-ORV sampling from the closest historic Raboral V-RG® area in Virginia was used 

for reference; due to rare high seroprevalence this area was formally sampled pre and post-ORV 

with Raboral V-RG® in 2012 but will not be formally sampled again in 2013

 Raccoons and skunks present

 Raccoon rabies present east of existing ORV zone

 Continued local support within state and county

 WS infrastructure in place

3) FIELD TRIAL PLOT SIZE

 Total area: 2,342.84 km2 including 26.85 km2 ground baiting

 6 distance buffered (4 ONRAB and 2 Raboral V-RG®) 126.84 km2 cells (11.2 x 11.2 km) for pre 

and post-ORV sampling in West Virginia

4) BAITING CHARACTERISTICS

 Total baits in ONRAB zone: 131,400 (129,876 fixed-wing and 1,524 ground) 

 Bait density: 75 baits/km2

(ONRAB and Raboral V-RG®)

 Approximately 14,000 ONRAB or Raboral V-RG® baits/sampling cell

 Flight line spacing: 750 m 

 Off-time: 27% for fixed wing and an average of 24% for ground using NLCD to determine 

“baitable” habitat 

 Projected baiting dates: August 31-September 5, 2013

 Baiting duration: 1 day, 5 planes and ground crews for hand-baiting

45
5) BAIT-VACCINE CHARACTERISTICS

 Each bait contains 1.8 ± 0.1ml of ONRAB vaccine (titer of not < 109.5 cell culture infectious dose 

50% [CCID50]/ml)

 Bait matrix is comprised of partially hydrogenated vegetable shortening (34%), Microbond wax 

(30%), stearine (12.5%), Icing sugar (20%), vegetable oil (1%), artificial marshmallow flavor 

(1%), artificial sweet flavor (1%), and a fat-soluble food dye (0.5%)

 Bait matrix contains 100 mg of tetracycline hydrochloride as a biomarker

 Each vaccine-bait weighs approximately 4g

 The body of the blister pack is an elongated oval with dimensions of 30 x 14 x 10mm (1.81 x 0.55 

x 0.39in)

 Each bait contains a conspicuous advisory label with a toll free number in the event of a bait 

contact and potential vaccine exposure 

6) PRE-ORV SAMPLING (BASELINES)

 Enhanced rabies surveillance has been in place for more than 1 year

 In late summer 2013, 150 raccoon-sized cage traps will be tended for 10 consecutive days within 

each of the 6 sampling cells (4 ONRABand 2 Raboral V-RG®); Traps will be deployed within 

half a mile (800 meters) of predetermined random trapping locations

 Expect capture rate of~100 raccoons/cell based on recent previous trapping efforts in area

 Attempt to maximize skunk captures by additional targeted trapping if practical

 From raccoons and skunks: collect pertinent biological, physical and spatial-temporal data; sera 

for rabies and human adenovirus serological analysis (at least 2 vials per animal if practical); first 

premolar teeth for age determination and biomarker analysis; mark and release at site of capture

 Euthanize target species with unusual lesions or behaviors for analysis

 Opportunistic sampling for additional target and nontarget species (e.g., roadkills or live animals) 

that display abnormal behavior or have lesions that should be evaluated

 Use various media outlets to advise the public when and where baiting will occur and 

precautions to be followed to reduce chance of vaccine exposure

7) POST-ORV SAMPLING (TREATMENT EFFECTS) 

 Continue enhanced rabies surveillance

 Continue opportunistic sampling for target and nontarget species (e.g., roadkills, hunter harvest) 

that display abnormal behavior or have lesions that should be submitted for analysis

 5 weeks post ORV sample for a target of ~100 raccoons and as many skunks as practical within 

each of the 6 cells using the pre-ORV target species trapping protocol

 Collect pertinent biological, physical and spatial-temporal data from raccoons and skunks as well 

as sera for rabies and human adenovirus analysis (at least 2 vials per animal if practical) and first 

premolar teeth for age determination and biomarker analysis

 Use acceptable algorithm with appropriate public health, agriculture and wildlife officials to 

ensure bait contacts are reported through a legible, toll-free phone number on each bait or other 

sources and addressed by the proper expertise

46
8) SAMPLE ANALYSIS 

 Rabies virus titers to be determined by CDC or GARC, Atlanta, GA

 Human adenovirus titers to be determined by Dr. Dubovi, Cornell University, Ithaca, NY

 Specific age determination and biomarker detection by Matson’s Laboratory, Milltown, MT

9) REPORT FINDINGS

 Expect results from analysis of field data by April 2014

 Draft report by June 2014

Figure 4. Baiting plan for the West Virginia ONRAB field trial in 2013, including location of the four 

ONRAB field trial sampling cells and the two Raboral V-RG® sampling cells.

47