Plum Island Animal Disease Center
DHS and USDA Are Successfully Coordinating Current Work, but Long-Term Plans Are Being Assessed Gao ID: GAO-06-132 December 19, 2005The livestock industry, which contributes over $100 billion annually to the national economy, is vulnerable to foreign animal diseases that, if introduced in the United States, could cause severe economic losses. To protect against such losses, critical research and diagnostic activities are conducted at the Plum Island Animal Disease Center in New York. The Department of Agriculture (USDA) was responsible for Plum Island until June 2003, when provisions of the Homeland Security Act of 2002 transferred the facility to the Department of Homeland Security (DHS). Under an interagency agreement, USDA continues to work on foreign animal diseases at the island. GAO examined (1) DHS and USDA coordination of research and diagnostic activities, (2) changes in research and diagnostic priorities since the transfer, and (3) long-term objectives of joint activities at Plum Island.
DHS and USDA's coordination at Plum Island Animal Disease Center has been largely successful because of the agencies' early efforts to work together to bring structure to their interactions at the island. For example, prior to the transfer, officials from DHS and USDA worked in concert to develop a written interagency agreement--effective when the island was transferred to DHS--that coordinated management activities. Subsequently, DHS and USDA created a detailed strategy to guide their joint work on foreign animal disease research and diagnostics. According to this joint strategy, DHS's role is to augment the research and diagnostic work that USDA's Agricultural Research Service (ARS) and the Animal and Plant Health Inspection Service (APHIS) conduct at the island. Since the transfer, budget changes, in part, have modified overall priorities and the scope of work at the island. First, ARS narrowed its research priorities to focus its work primarily on a single foreign animal disease, foot-and-mouth disease (FMD). Traditionally one of the high-priority diseases studied at Plum Island, FMD has emerged as its top research priority because, according to officials, it poses the greatest threat of introduction because of its virulence, infectivity, and availability. Other research programs have been terminated or are proceeding at a slower pace. National experts we consulted confirmed the importance of studying FMD, but stated that it is also important to study a variety of other diseases to remain prepared. They suggested that, to free up limited space at the facility, some of the work that does not require the unique features of Plum Island could be performed elsewhere: for example, work that does not involve the use of a live virus, such as certain aspects of vaccine development. Second, while APHIS's overall priorities have not changed, diagnostic work has been curtailed. Officials said that, after the transfer, because the agency did not receive an expected budget increase, their plans to expand development of diagnostic tools for high-priority diseases were curtailed. This work is vital to rapidly identifying diseases when outbreaks occur. APHIS officials told us that the funds to support work on diagnostic tools remain insufficient. Finally, DHS has assumed responsibility for operations and maintenance at Plum Island and has established an applied research science and agricultural forensics team. While DHS and USDA plan to continue to work together on FMD, agency officials told us that it is not prudent to speculate on long-term objectives at Plum Island, in part, because DHS has plans to replace the Plum Island Animal Disease Center with a new, modernized facility that could be located at Plum Island or elsewhere. Pending congressional approval, DHS estimates that the new facility will be fully operational by 2012.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-06-132, Plum Island Animal Disease Center: DHS and USDA Are Successfully Coordinating Current Work, but Long-Term Plans Are Being Assessed
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Report to Congressional Committees:
December 2005:
Plum Island Animal Disease Center:
DHS and USDA Are Successfully Coordinating Current Work, but Long-Term
Plans Are Being Assessed:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-06-132]:
GAO Highlights:
Highlights of GAO-06-132, a report to congressional committees:
Why GAO Did This Study:
The livestock industry, which contributes over $100 billion annually to
the national economy, is vulnerable to foreign animal diseases that, if
introduced in the United States, could cause severe economic losses. To
protect against such losses, critical research and diagnostic
activities are conducted at the Plum Island Animal Disease Center in
New York. The Department of Agriculture (USDA) was responsible for Plum
Island until June 2003, when provisions of the Homeland Security Act of
2002 transferred the facility to the Department of Homeland Security
(DHS). Under an interagency agreement, USDA continues to work on
foreign animal diseases at the island. GAO examined (1) DHS and USDA
coordination of research and diagnostic activities, (2) changes in
research and diagnostic priorities since the transfer, and (3) long-
term objectives of joint activities at Plum Island.
What GAO Found:
DHS and USDA‘s coordination at Plum Island Animal Disease Center has
been largely successful because of the agencies‘ early efforts to work
together to bring structure to their interactions at the island. For
example, prior to the transfer, officials from DHS and USDA worked in
concert to develop a written interagency agreement”effective when the
island was transferred to DHS”that coordinated management activities.
Subsequently, DHS and USDA created a detailed strategy to guide their
joint work on foreign animal disease research and diagnostics.
According to this joint strategy, DHS‘s role is to augment the research
and diagnostic work that USDA‘s Agricultural Research Service (ARS) and
the Animal and Plant Health Inspection Service (APHIS) conduct at the
island.
Since the transfer, budget changes, in part, have modified overall
priorities and the scope of work at the island. First, ARS narrowed its
research priorities to focus its work primarily on a single foreign
animal disease, foot-and-mouth disease (FMD). Traditionally one of the
high-priority diseases studied at Plum Island, FMD has emerged as its
top research priority because, according to officials, it poses the
greatest threat of introduction because of its virulence, infectivity,
and availability. Other research programs have been terminated or are
proceeding at a slower pace. National experts we consulted confirmed
the importance of studying FMD, but stated that it is also important to
study a variety of other diseases to remain prepared. They suggested
that, to free up limited space at the facility, some of the work that
does not require the unique features of Plum Island could be performed
elsewhere: for example, work that does not involve the use of a live
virus, such as certain aspects of vaccine development. Second, while
APHIS‘s overall priorities have not changed, diagnostic work has been
curtailed. Officials said that, after the transfer, because the agency
did not receive an expected budget increase, their plans to expand
development of diagnostic tools for high-priority diseases were
curtailed. This work is vital to rapidly identifying diseases when
outbreaks occur. APHIS officials told us that the funds to support work
on diagnostic tools remain insufficient. Finally, DHS has assumed
responsibility for operations and maintenance at Plum Island and has
established an applied research science and agricultural forensics
team.
While DHS and USDA plan to continue to work together on FMD, agency
officials told us that it is not prudent to speculate on long-term
objectives at Plum Island, in part, because DHS has plans to replace
the Plum Island Animal Disease Center with a new, modernized facility
that could be located at Plum Island or elsewhere. Pending
congressional approval, DHS estimates that the new facility will be
fully operational by 2012.
What GAO Recommends:
To make more effective use of limited space, GAO recommends that DHS,
in consultation with USDA, pursue opportunities to shift work that does
not require the unique features of Plum Island to other institutions.
In commenting on a draft of this report, DHS and USDA generally agreed
with the recommendation, but DHS believes it has already addressed it.
We believe that more work is needed.
www.gao.gov/cgi-bin/getrpt?GAO-06-132.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Robert A. Robinson at
(202) 512-3841 or robinsonr@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
DHS and USDA Have Successfully Coordinated Research and Diagnostic
Programs at Plum Island:
Budget Changes at Time of the Transfer in Part Modified Overall
Priorities and the Scope of Work at Plum Island:
DHS and USDA Are in the Process of Assessing Long-Term Plans for Joint
Work at Plum Island:
Conclusions:
Recommendation for Executive Action:
Agency Comments:
Appendixes:
Appendix I: Scope and Methodology:
Appendix II: List of Experts Interviewed:
Appendix III: Animal Diseases That Affect Livestock:
Appendix IV: Comments from the Department of Homeland Security:
GAO Comments:
Appendix V: Comments from the U.S. Department of Agriculture:
GAO Comments:
Appendix VI: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: ARS Plum Island Funding, Fiscal Years 2002-2005:
Table 2: APHIS Plum Island Funding, Fiscal Years 2002-2005:
Table 3: List of Animal Diseases:
Figures:
Figure 1: The DHS Homeland Security Biodefense Complex
Figure 2: Funding Allocations at Plum Island before and after the
Transfer
Figure 3: A Laboratory Technician Evaluates Tissue Samples at Plum
Island
Figure 4: Veterinarians Participate in Training on Foreign Animal
Diseases at Plum Island:
Abbreviations:
APHIS: Animal and Plant Health Inspection Service:
ARS: Agricultural Research Service:
DHS: Department of Homeland Security:
FMD: foot-and-mouth disease:
Joint Strategy: Joint DHS and USDA Strategy for Foreign Animal Disease
Research and Diagnostic Programs:
OMB: Office of Management and Budget:
S&T: Science and Technology Directorate:
USDA: U.S. Department of Agriculture:
Letter December 19, 2005:
The Honorable Robert F. Bennett:
Chairman:
The Honorable Herb Kohl:
Ranking Minority Member:
Subcommittee on Agriculture, Rural Development, and Related Agencies:
Committee on Appropriations:
United States Senate:
The Honorable Henry Bonilla:
Chairman:
The Honorable Rosa DeLauro:
Ranking Minority Member:
Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies:
Committee on Appropriations:
House of Representatives:
Over 40 contagious animal diseases identified in other countries--known
as foreign animal diseases--threaten the United States' agriculture
economy, the largest and most integrated in the world. A key component
of this economy is the livestock industry, which contributes over $100
billion annually to the gross domestic product. To protect the nation's
animal industries and exports from catastrophic economic losses that
would result from the deliberate or accidental introduction of a
foreign animal disease, scientists and veterinarians conduct critical
research and diagnostic activities at the Plum Island Animal Disease
Center, located off the coast of New York.
Plum Island's research and diagnostic activities stem from its mission
to protect U.S. animal industries and exports from deliberate or
accidental introductions of foreign animal diseases. The United States
is normally free of such diseases, and highly contagious pathogens
could cause disastrous losses in the agriculture sector if they were
released outside the facility. Plum Island's activities include
conducting research to develop more sensitive and accurate methods of
disease detection and identification; developing new strategies to
control disease epidemics, including new vaccines and antiviral drugs;
investigating suspected cases of foreign animal disease outbreaks in
the United States; producing and maintaining materials used in
diagnostic tests and vaccines; and training animal health professionals
to recognize and diagnose foreign animal diseases. Moreover, Plum
Island is the only facility in the United States that is currently
approved to study high-consequence foreign livestock diseases, such as
foot-and-mouth disease (FMD), because its laboratory has been equipped
with a specially designed biocontainment area that meets specific
safety measures.[Footnote 1] Plum Island's work involves large
mammalian animals. In fact, it is the only facility in the United
States that has special safety features required to study certain high
consequence foreign animal diseases in large animals. Research on other
highly pathogenic animal diseases is being conducted at other
facilities. For example, highly pathogenic avian influenza is being
studied at the U.S. Department of Agriculture's (USDA) Southeast
Poultry Research Laboratory in Athens, Georgia, and is being diagnosed
at the National Veterinary Services Laboratories in Ames, Iowa.
USDA was responsible for Plum Island until June 1, 2003, when
provisions of the Homeland Security Act of 2002 were
implemented.[Footnote 2] The act transferred Plum Island, including all
of its assets and liabilities, to the Department of Homeland Security
(DHS). This action shifted overall responsibility for Plum Island to
DHS, including all of the costs associated with facility maintenance,
operations, and security. The act specified that USDA would continue to
have access to Plum Island to conduct diagnostic and research work on
foreign animal diseases, and it authorized the President to transfer
funds from USDA to DHS to operate Plum Island.[Footnote 3]
Responding to concerns from the agriculture sector that the transfer of
responsibilities at Plum Island could shift the focus away from
agriculture to other DHS priorities, the members of a congressional
conference committee inserted language in the conference report
accompanying the Consolidated Appropriations Act for fiscal year 2005
requesting that we report on the coordination efforts between DHS and
USDA and describe the long-term objectives of joint activities at Plum
Island.[Footnote 4] In this context, we examined (1) how DHS and USDA
coordinate research and diagnostic activities at Plum Island; (2) what
changes, if any, have taken place regarding research and diagnostic
priorities at Plum Island since the transfer, and the reasons for and
implications of such changes; and (3) the long-term objectives of joint
DHS and USDA activities at Plum Island.
To address the first and second objectives, we analyzed DHS and USDA
strategy documents and interviewed officials at various levels from
each agency, including senior leadership officials in Washington, D.C.
We also reviewed budget data and interviewed analysts and officials at
DHS, USDA, and the Office of Management and Budget (OMB); lead
scientists based at Plum Island; and former USDA scientists who left
Plum Island after its transfer to DHS. In addition, we reviewed agency
budget documents and other budgetary information provided by the
agencies to identify changes in funding levels since the transfer and
to determine the funding allocations among the programs at Plum Island,
before and after the transfer.
We also interviewed selected animal disease experts to respond to the
second objective. We selected our experts for their diverse
perspectives and technical expertise on animal health and diseases
based on the following criteria: (1) recommendations we received from
others knowledgeable in the field of foreign animal diseases; (2) area
of expertise and experience; and (3) the type of organization
represented, including academic institutions and associated research
centers.
To address the third objective, we analyzed agency planning documents
and interviewed senior leadership officials representing DHS and USDA.
Additional details about our scope and methodology are presented in
appendix I. We performed our work from March 2005 to December 2005 in
accordance with generally accepted government auditing standards.
Results in Brief:
Efforts to coordinate work at Plum Island have been largely successful.
This success is attributable to DHS and USDA agreeing to work together
early on to bring structure to their interactions at the island. For
example, an official from USDA's Agricultural Research Service (ARS)
told us that prior to the transfer, staff from DHS and USDA worked
together to develop a written interagency agreement--effective when the
island was transferred--that coordinated management activities.
Furthermore, DHS and USDA created a detailed strategy to guide their
joint work on the island's two critical functions--conducting research
on foreign animal diseases and providing diagnostic services to
identify such diseases. According to the strategy, DHS's role is to
augment the research and diagnostic work that USDA's ARS and Animal and
Plant Health Inspection Service (APHIS) conduct at the island. For
example, DHS's scientists will expand on basic ARS research by
advancing efficacy testing and development of vaccines to enhance the
nation's ability to respond to a bioterrorism attack. ARS's role at
Plum Island continues to involve fundamental research, such as studying
the immune response of livestock infected with FMD. APHIS continues to
diagnose diseases in livestock and train veterinarians to recognize and
diagnose foreign animal diseases. In addition to the joint strategy,
DHS and USDA established two other formal mechanisms to ensure that
their respective missions are well integrated and to guide routine
activities: a Board of Directors and an interagency working group,
known as the Senior Leadership Group. The board is composed of top
officials from DHS, ARS, and APHIS, and it is responsible for overall
management and operations as well as the island's research strategy.
The Senior Leadership Group includes one representative from each of
the three agencies and addresses immediate on-site management
decisions, such as scheduling use of limited laboratory space and
shared equipment. Finally, according to the staff we interviewed,
frequent informal communication among scientists at the island has
contributed to effective coordination.
Program budget changes that occurred soon after the transfer--resulting
in part from implementation of the Homeland Security Act of 2002--
modified overall priorities and the scope of work at the island.
* First, ARS narrowed its research priorities to focus its work
primarily on a single foreign animal disease, FMD. Traditionally one of
the high-priority diseases studied at Plum Island, FMD has emerged as
the facility's top research priority following the transfer to DHS
since, according to officials, it poses the greatest threat of
deliberate introduction because of its virulence, infectivity, and
availability. Also, ARS responded to budget reductions by slowing
research on another high-priority disease--classical swine fever--and
by terminating other research programs, such as one for African swine
fever. At the same time, ARS negotiated agreements with other
organizations, including DHS, under which ARS was reimbursed to carry
out mutually beneficial research. The amount of these reimbursements
equaled about 80 percent of the total reduction in the ARS program
budget that occurred in 2003 after the transfer. Commenting on the new
focus of research at Plum Island, most of the nationally recognized
animal disease experts we interviewed agreed that it may be prudent to
divert limited funds from diseases of lesser importance to the U.S.
economy, such as African swine fever, to study FMD. However, all of the
experts expressed concerns that focusing research on a single disease
makes livestock more vulnerable to diseases that are not being studied
to the same extent or, in some cases, at all. Some of the experts also
said that although Plum Island is the only domestic facility where
scientists are currently authorized to study live, high-consequence
foreign animal disease agents in large animals, some of the research
being conducted at the island could be performed elsewhere.
Specifically, work that does not involve the use of a live virus, such
as certain aspects of vaccine development, does not require the strict
biosafety features of Plum Island.
* Second, APHIS's disease diagnostic priorities have not changed, but
plans to expand diagnostic services have been curtailed because,
according to officials, the agency did not receive an expected budget
increase after the transfer. APHIS officials told us that this slowed
their plans to expand development of diagnostic tools for high-priority
diseases--work that is vital to rapidly identifying diseases when
outbreaks occur. However, in fiscal years 2004 and 2005, DHS paid APHIS
to perform diagnostic work at Plum Island on DHS's behalf. Despite
APHIS not receiving the expected budget increase, the sum of the 2004
DHS reimbursement and the 2004 allocation to the APHIS laboratory at
Plum Island are roughly equivalent to the APHIS program budget in the
fiscal year before the transfer. APHIS and DHS officials agree that the
reimbursements are not an appropriate way to support the agency's
diagnostic work. APHIS officials believe that funds to support work on
diagnostic tools remain insufficient.
* Third, DHS is now responsible for all of the costs associated with
operating and maintaining Plum Island. In addition, the agency
continues to implement major infrastructure improvements and is
developing its own applied research program. DHS has also used
programmatic funds to establish a bioforensics laboratory at Plum
Island and plans to use the bioforensics laboratory to validate
forensic assays.
Finally, although DHS and USDA officials told us that they plan to
continue to work together on FMD, they also said it is not prudent to
speculate on the long-term objectives of future joint work at Plum
Island, in part, because DHS has plans to replace the existing facility
with a new, modernized one at Plum Island or elsewhere. DHS officials
believe that this change is necessary because of the shortcomings of
the current laboratory facilities at Plum Island, which include
insufficient space and an outdated infrastructure. DHS expects that the
new facility will expand its capabilities to protect animal health
against terrorist attacks. DHS estimates that, pending congressional
approval, the new facility will be fully operational by 2012. DHS
officials told us that they have not yet determined the scope of the
work to be performed at this new facility, or the facility's size or
location--whether Plum Island or elsewhere. They also indicated that
they do not yet know whether the new facility would address current
research gaps, such as the lack of a higher biosecurity laboratory than
Plum Island currently has. Such a laboratory would enable the study of
other highly contagious viruses in large animals, such as Nipah virus,
which affects swine and can also be fatal to humans. DHS officials
emphasized that the dynamic nature of threat assessments makes it
difficult to firmly commit to long-term priorities because information
and research needs may change depending on the nature of the threat.
DHS and USDA officials confirmed that as they explore future work on
foreign animal diseases, whether at Plum Island or elsewhere, they will
rely on the joint strategy and the mechanisms they have established to
implement this strategy to coordinate the effort.
We are making a recommendation aimed at ensuring the effective use of
limited space at Plum Island while longer term plans for a new facility
are being developed. Specifically, we recommend that DHS, in
consultation with USDA, pursue opportunities to shift work that does
not require the unique features of Plum Island to other institutions
and research centers.
In commenting on a draft of this report, DHS and USDA generally agreed
with the report and its recommendation. DHS said that the report
accurately reflects the current relationships and coordination between
DHS and USDA at Plum Island. While DHS agreed with the recommendation,
the agency also believes that it has largely addressed it. While we
agree that important and valuable steps have been taken toward
implementing the recommendation, we believe additional actions are
necessary and have therefore left the recommendation in the report. In
particular, we have not seen evidence that DHS is coordinating its
assessment, which is still under way, of the laboratory and animal room
requirements at Plum Island with USDA.
Background:
Plum Island is a federally owned 840-acre island off the northeastern
tip of Long Island, New York. Scientists working at the facility are
responsible for protecting U.S. livestock against foreign animal
diseases that could be accidentally or deliberately introduced into the
United States. Animal health officials define an exotic or foreign
animal disease as an important transmissible livestock or poultry
disease believed to be absent from the United States and its
territories that has the potential to create a significant health or
economic impact.
Plum Island's scientists identify the pathogens that cause foreign
animal diseases and work to develop vaccines to protect U.S.
livestock.[Footnote 5] The primary research and diagnostic focus at
Plum Island is foreign or exotic diseases that could affect livestock,
including cattle, swine, and sheep. In addition to FMD and classical
swine fever, other types of livestock diseases that have been studied
at Plum Island include African swine fever, rinderpest, and various pox
viruses, such as sheep and goat pox. Appendix III provides more
extensive information on animal diseases of concern mentioned in this
report.
Some of the pathogens maintained at Plum Island are highly contagious;
therefore, research on these pathogens is conducted in a biocontainment
area that has special safety features designed to contain the
pathogens. If accidentally released, these pathogens could cause
catastrophic economic losses in the agricultural sector. The
biocontainment area includes 40 rooms for livestock and is the only
place in the United States that is equipped to permit the study of
certain contagious foreign animal diseases in large mammalian animals.
USDA uses this biocontainment area for basic research, diagnostic work,
and for clinical training of veterinarians in the recognition of
foreign animal diseases. These veterinarians would serve as animal
health first responders in the event of an emergency. The North
American Foot-and-Mouth Disease Vaccine Bank is also located on Plum
Island.[Footnote 6]
USDA had owned and operated Plum Island for nearly 50 years when, in
June 2003, the island and its assets and liabilities were transferred
to DHS. Plum Island is now part of a broader joint strategy developed
by DHS and USDA to protect against the intentional or accidental
introduction of foreign animal diseases. Under the direction of the
DHS's Science and Technology Directorate (S&T), the strategy for
protecting livestock also includes work at two of DHS's Centers of
Excellence, known as the National Center for Food Protection and
Defense and the National Center for Foreign Animal and Zoonotic Disease
Defense, as well as other centers within the DHS homeland security
biodefense complex. These include the National Biodefense Analysis and
Countermeasures Center and the Lawrence Livermore National Laboratory.
The strategy calls for building on the strengths of each agency's
assets to develop comprehensive preparedness and response capabilities.
(See fig. 1.)
Figure 1: The DHS Homeland Security Biodefense Complex:
[See PDF for image]
[End of figure]
According to the strategy, DHS and USDA now work together to address
national biodefense issues and carry out the mission of the Plum Island
Animal Disease Center as follows:
* DHS is responsible for coordinating the overall national effort to
enhance the protection of agriculture, which the President has defined
as a critical infrastructure sector. At Plum Island, DHS's Science and
Technology Directorate is working to advance the development of
vaccines and disease prophylactics based on ARS's basic research. Also,
DHS has established a bioforensics laboratory at Plum Island and is
working to conduct forensic analysis of evidence from suspected
biocrimes and terrorism involving a foreign animal disease attack.
* USDA/ARS scientists at Plum Island are responsible for basic research
on foreign livestock diseases and for early discovery of
countermeasures, such as evaluating countermeasures for rapid induction
of immunity in livestock.
* USDA/APHIS scientists are responsible for diagnosing livestock
diseases. Also, APHIS conducts diagnostic training sessions several
times a year to give veterinary health professionals the opportunity to
study the clinical signs of animal diseases found in other countries,
such as FMD.
Currently, in addition to visiting scientists and fellows, there are
approximately 70 federal research scientists, veterinarians,
microbiologists, laboratory technicians, and support staff working at
Plum Island. DHS and USDA's combined annual operating funds at Plum
Island, based on fiscal year 2005 allocations and other funds, is about
$60 million--USDA's funding is about $8 million, and DHS's is about $51
million (see fig. 2). Prior to the transfer of Plum Island to DHS, ARS
and APHIS shared responsibility for operating costs, although ARS had
primary responsibility for the facility. According to agency officials,
both agencies received appropriations to execute their research and
diagnostic missions, out of which operations and maintenance costs had
to be funded. Neither ARS nor APHIS received a specific appropriation
for operations and maintenance activities. Now, DHS is responsible for
operations and maintenance costs as well as programmatic costs that DHS
incurs directly. ARS and APHIS continue to receive funding from USDA to
support their own programmatic activities at the island.
Figure 2: Funding Allocations at Plum Island before and after the
Transfer:
[See PDF for image]
Notes: Research funds do not include those allocated to the research
consortium for animal vaccines. Congress requires ARS to provide funds
directly to participating universities.
The funding amounts listed for ARS and APHIS include funds received
from other agencies and entities (including DHS) through reimbursable
agreements.
[End of figure]
DHS and USDA Have Successfully Coordinated Research and Diagnostic
Programs at Plum Island:
DHS's and USDA's efforts to coordinate research and diagnostic programs
at Plum Island have been largely successful because of the agencies'
early efforts to work together to bring structure to their interaction
at the island. For example, the agencies developed a joint strategy
that outlines how they will pursue their shared mission at Plum Island.
They also developed formal mechanisms for coordination, and they rely
on frequent informal communication among scientists at Plum Island. The
scientists also attribute effective coordination and resolution of
transition difficulties to skilled management at Plum Island.
Joint DHS and USDA Strategy Serves as Basis to Prioritize and
Coordinate Work:
Our review shows a largely positive experience thus far in the
coordination of DHS and USDA activities at Plum Island. The success of
the agencies resulted from their early efforts to work together to
bring structure to their interactions at the island. The agencies
developed a framework for coordination in several stages.
* First, in accordance with provisions of the Homeland Security Act of
2002, DHS, ARS, and APHIS worked together before the transfer to
establish an interagency agreement. The purpose of the agreement is to
establish written guidelines that identify each agency's role and to
coordinate immediate operations and maintenance needs, such as fiscal
responsibilities and the use of shared equipment. Effective on the day
of the transfer, this agreement remained in place while the agencies
completed a more detailed strategic plan.[Footnote 7]
* Second, a working group, composed of DHS, ARS, and APHIS officials,
as well as representatives from nongovernmental producer groups,
convened about one month after the transfer to review the island's
mission and priorities and to develop a strategy for coordination.
According to a USDA official, DHS recognized that, as a newly
established agency, it needed to seek technical expertise through this
interagency group. The group began by discussing foreign animal
diseases from a broad perspective to inform the new DHS staff about key
issues. Subsequent meetings became more focused as stakeholders
evaluated the capabilities of the island and its programs, and
identified shortfalls and a common priority for the agencies--FMD. The
group finalized a joint strategy to address this priority in August
2004.
The Joint DHS and USDA Strategy for Foreign Animal Disease Research and
Diagnostic Programs (Joint Strategy) serves as the basis for the
agencies to prioritize and coordinate work on Plum Island's two
critical functions--conducting research on foreign animal diseases and
providing diagnostic services to identify such diseases. The Joint
Strategy describes the role of each agency at Plum Island; identifies
the agencies' common goal to address the threat of foreign animal
disease introduction; and outlines the activities that DHS, ARS, and
APHIS are to perform to fulfill that goal. In particular, the Joint
Strategy identifies gaps in the federal government's effort to address
foreign animal diseases and specifies how DHS programs will fill those
gaps. For example, DHS will use its resources and expertise to support
efficacy testing and advanced development--an identified gap--of
improved vaccines for FMD that showed promising results in the early
research stages--i.e., basic research--performed by ARS scientists.
Under the terms of the Joint Strategy, ARS and DHS will conduct
research to develop products, such as vaccines, antivirals, and
diagnostic tools, that could be used by APHIS, sold on the market, or
both. ARS will continue to focus on the early stages of the work and
conduct basic research, which explores generally untested ideas.
Examples of recent ARS basic research include obtaining new knowledge
about diseases and their causative agents and studying the immune
responses of livestock infected with FMD. DHS will augment the ARS work
by performing targeted applied research, which is intended to lead to
the practical use of the most promising basic research results. Among
other things, DHS scientists will work with the results from ARS
experiments toward developing those concepts into tangible products
that will enhance the nation's ability to respond to a bioterrorism
attack. For example, ARS scientists could prove a vaccine concept in
laboratory experiments, while DHS could conduct the efficacy testing of
this vaccine, which would lead to securing licenses required for full-
scale manufacture of a vaccine product.
Figure 3: A Laboratory Technician Evaluates Tissue Samples at Plum
Island:
[See PDF for image]
[End of figure]
Finally, the Joint Strategy confirms the role of APHIS to conduct
confirmatory diagnostic work, develop and validate diagnostic test
methods, support the federal and state network of laboratories intended
to quickly respond to disease outbreaks, and train veterinarians to
recognize and diagnose foreign animal diseases. The Joint Strategy also
identifies ways that DHS will augment the diagnostic role of APHIS. DHS
will not initiate diagnostic services at the island, but will
contribute to APHIS work by supporting validation and deployment of
rapid diagnostic technologies and enhancing training capabilities. For
example, DHS has modernized educational equipment used by APHIS to
teach students and veterinarians about diagnosing foreign animal
diseases. DHS has also established its bioforensic laboratory at Plum
Island, and DHS scientists will use this laboratory to validate the
forensic assays used for FMD.[Footnote 8]
DHS and USDA Rely on Formal and Informal Communication to Coordinate
Activities:
In addition to the Joint Strategy, the agencies established two other
formal mechanisms to ensure that their respective missions are well
integrated and to guide routine activities: a Board of Directors and an
interagency working group known as the Senior Leadership Group. The
agencies also rely on frequent informal communication among scientists
and the leadership at Plum Island to further enhance coordination.
Composed of top officials from DHS, ARS, and APHIS, the Board of
Directors focuses on overall strategic issues and meets on a quarterly
basis. The board includes the DHS Director of the Office of Research
and Development, Science and Technology Directorate, and the
administrators of both ARS and APHIS. The Director of Plum Island, a
DHS employee, participates as the Executive Secretary, but is not a
member of the board. The board maintains responsibility for
coordination and oversight of all matters relating to the management,
administration, research strategy, and operations at Plum Island. The
board also ensures that the operation of the facility at Plum Island
fulfills the agriculture security mission of the Science and Technology
Directorate, ARS, and APHIS.
On the other hand, the Senior Leadership Group provides local
management and focuses on immediate on-site management decisions, such
as scheduling use of limited laboratory space. The Plum Island-based
leaders from each agency make up the Senior Leadership Group, and they
meet on at least a monthly basis. The group's responsibilities include
(1) establishing operational procedures and practices and conducting
strategic planning for future needs, (2) ensuring that individuals who
use the facility adhere to its operational procedures and practices,
(3) scheduling use of the facility and shared equipment, (4)
establishing policies for workers to access the facility, (5) reviewing
the compatibility of the work performed at the facility with the
island's mission and operations, (6) identifying and coordinating
program management for joint projects, and (7) coordinating continuity
of operations procedures.[Footnote 9]
The staff we interviewed at Plum Island also said that frequent
informal communication among scientists has contributed to effective
coordination. According to the Director of Plum Island, scientists
discuss their work with one another on an almost daily basis. One
scientist noted that the informal dialogue creates a collaborative
environment, thereby strengthening their work. The ease of informal
communication appears to have resulted in part from existing
relationships among the scientists in the three agencies--some of the
scientists that now work for DHS at Plum Island previously worked for
ARS and APHIS at the island.
In addition, the lead scientists we spoke with attributed the effective
integration of DHS at the facility in part to the skilled leadership of
the Plum Island Director. For example, several scientists believe that
the leader's successful efforts in facilitating open communication
among staff have fostered a collaborative environment. Moreover,
several noted that the leaders currently based on the island value the
comments and ideas expressed by the scientists. One lead scientist
concluded that the Director's ability to establish positive
relationships with staff has brought greater focus to the research and
diagnostic programs. USDA officials also noted that the leadership of
the Director and the entire Senior Leadership Group, working as a team,
have contributed to effective cooperation at Plum Island.
Finally, while there is now good coordination among the agencies at
Plum Island, scientists acknowledged that they experienced some
administrative difficulties during the transition period. The
scientists we spoke with generally viewed challenges such as these as
inevitable given the complexity of transferring responsibility for
operations to a new agency and incorporating new programs in the
existing facility. For example, one scientist said that the lack of
procurement officers initially posed a burden to scientists. He had to
perform the duties of a procurement officer--searching for the
products, obtaining cost estimates, and completing extensive paperwork-
-when he needed new supplies and equipment. As a result, this scientist
had to forgo some of his limited time in the laboratory and delay his
research while he learned how to process procurement orders. This
scientist noted, however, that he expected this to be a temporary
problem because the agency has since hired administrative staff. DHS
officials noted that two procurement officers currently are working at
Plum Island, which should alleviate this type of problem in the future.
Budget Changes at Time of the Transfer in Part Modified Overall
Priorities and the Scope of Work at Plum Island:
Program budget changes that occurred soon after the transfer--resulting
in part from implementation of the Homeland Security Act of 2002--
modified overall priorities and the scope of USDA's work at Plum
Island. Traditionally one of the high priorities at Plum Island, FMD
has emerged as the facility's top research priority. According to ARS
officials, the agency slowed or terminated other research activities in
response to the budget reductions that occurred soon after the transfer
of the facility to DHS. Many of the experts we spoke with raised
concerns about focusing Plum Island's research resources on one
disease. They also noted that some of the aspects of the research being
conducted at the island could be performed elsewhere. With regard to
the diagnostic component of Plum Island, APHIS's priorities have not
changed, but APHIS officials told us that budget changes at the time of
the transfer curtailed the planned expansion of diagnostic services.
DHS is now responsible for all of the costs associated with operating
and maintaining Plum Island. In addition, DHS continues to implement
major infrastructure improvements and is developing its applied
research science and agricultural forensics program.
ARS Is Focusing Its Research on FMD, While Other Programs Were
Terminated or Slowed Down Because of Budget Reductions:
After the transfer, ARS designated FMD--traditionally one of the high-
priority diseases at Plum Island--as its top research priority because
it poses the greatest threat to the agriculture economy. Also, ARS
responded to budget reductions by slowing research on other high-
priority diseases, such as classical swine fever, and by terminating
research on other diseases, including African swine fever. According to
ARS officials, the agency determined the current research priorities--
FMD and, to a lesser extent, classical swine fever--using its research
plan, which was developed under the agency's formal planning process,
known as the National Program review.[Footnote 10]
In addition to the priorities established by the National Program
review, an ARS official told us that the agency also considered other
assessments, including those of the White House Office of Science and
Technology Policy Blue Ribbon Panel on the Threat of Biological
Terrorism Directed Against Livestock. These assessments consistently
ranked African swine fever as a lower threat to the United States than
FMD and classical swine fever, and ranked FMD as the top threat to the
agriculture economy from a deliberate introduction because of its
virulence, infectivity, and availability. African swine fever has been
perceived as a less imminent threat to the United States because,
according to USDA, outbreaks require a vector, such as a tick, to
spread the disease.
As a result of these assessments, as well as a budget reduction soon
after the transfer, ARS officials told us that the agency had to slow
the pace of some research projects and terminate others. Specifically,
ARS terminated the African swine fever research program, which included
genomic sequencing of large DNA viruses, and slowed the pace of work on
classical swine fever.[Footnote 11] While these officials acknowledged
the need to make FMD a research priority at Plum Island, they raised
concerns about the effect of budget reductions on other diseases of
concern. For example, research on classical swine fever, which included
development of a marker vaccine, is proceeding at a slower pace than it
did before the budget reductions.[Footnote 12] An ARS official
estimated that the reduced funds for classical swine fever research
will extend the project timeline about 5 to 10 years.[Footnote 13] Such
delays postpone the development of products that would improve the
nation's ability to respond to and manage an outbreak of disease.
Since ARS is no longer responsible for operations and maintenance costs
at Plum Island, funds to meet these expenses were transferred to DHS in
fiscal year 2003. However, a reduction of ARS's programmatic funds for
research conducted at Plum Island also occurred. ARS budget data show
that the agency's programmatic funds decreased by 45 percent between
fiscal years 2003 and 2004. These changes are the result of OMB's
actions to create the first DHS budget for Plum Island in fiscal year
2004. According to an OMB budget examiner, all of the funding for
facility operations was transferred to DHS. OMB also divided Plum
Island program funds equally between DHS and USDA in fiscal year 2004.
ARS negotiated agreements with other government agencies (including
DHS) and a nongovernmental entity under which ARS was reimbursed to
carry out mutually beneficial research.[Footnote 14] The amount of
these reimbursements equaled about 80 percent of the reduction in the
ARS program budget in 2003 after the transfer. For example, in fiscal
years 2004 and 2005, ARS received reimbursements from DHS for research
ARS performed in support of DHS's mission. Reimbursements from these
agreements, which an ARS official told us are not guaranteed to
continue in fiscal year 2006 or beyond, decreased from fiscal year 2004
through 2005. One ARS management analyst noted that the agency cannot
factor these reimbursements into program planning because of their
inherent uncertainty--such agreements are negotiated as reimbursements
on a case-by-case basis after the agency has completed the work.
DHS officials stated that it may appear that ARS's research budget was
reduced posttransfer more than it actually was because it is not clear
from ARS's fiscal year 2002 and 2003 budgets how much of those budgets
included indirect costs (i.e., research overhead costs) and operations
and maintenance costs. ARS's budget data for fiscal years 2002 and
2003, however, do not distinguish between indirect costs and operations
and maintenance costs. According to an ARS official, DHS now pays for
some of the indirect research costs at Plum Island, and the agencies
continue to negotiate how to share indirect support costs on a case-by-
case basis.
Table 1 summarizes the net effect of the budget reductions and
subsequent funding on ARS's research resources, exclusive of building
and facility funds, at Plum Island for fiscal years 2002 through 2005.
Table 1: ARS Plum Island Funding, Fiscal Years 2002-2005:
Dollars in millions.
Total allocated funds[A];
2002: $12.9;
2003: $12.7[B];
2004: $4.3;
2005: $4.8.
Total allocated funds[A]: Operations and maintenance[C];
2002: $7.1[C];
2003: $4.4[C];
2004: 0;
2005: 0.
Total allocated funds[A]: Indirect costs[C];
2002: [C];
2003: [C];
2004: $0.560;
2005: $0.235.
Total allocated funds[A]: Program funds;
2002: $5.8;
2003: $8.3;
2004: $3.7;
2005: $4.6.
Funds allocated to research consortium[D];
2002: ($1.7);
2003: ($1.8);
2004: ($1.1);
2005: ($1.3).
Funds transferred to DHS;
2002: [E];
2003: ($3.2);
2004: [E];
2005: [E].
Reimbursable interagency agreements and other sources[F];
2002: $0.691;
2003: $0.629;
2004: $3.7;
2005: $2.3.
Sum of net program funds and reimbursements received;
2002: $4.8;
2003: $3.9;
2004: $6.3;
2005: $5.6.
Source: GAO analysis of ARS data.
[A] Includes funding for programmatic activities as well as for
operations and maintenance. ARS was not responsible for maintenance and
operations costs at the facility after the transfer to DHS. In
addition, ARS has spent these funds, which are received from annual
appropriations and must be obligated by the end of each fiscal year.
[B] Amount that ARS planned, at the start of fiscal year 2003, to
allocate to Plum Island. Some of this allocation was then transferred
to DHS later that year under the Homeland Security Act of 2002.
[C] The operations and maintenance costs for fiscal years 2002 and 2003
include indirect research costs, which cover support staff and ARS
overhead at Plum Island, because the ARS budget did not distinguish
between indirect costs and operations and maintenance costs prior to
fiscal year 2004.
[D] The House Appropriations Committee directs ARS to provide these
funds directly to universities participating in a research consortium.
[E] The direct transfer of funds occurred only in fiscal year 2003. The
funds transferred from ARS to DHS in fiscal year 2003 included those
used for other facility costs, such as utility and fuel costs, and did
not include research dollars.
[F] Refers to reimbursements ARS received through agreements with other
governmental and nongovernmental entities. In fiscal years 2004 and
2005, these reimbursements include research funds obtained from DHS
through Economy Act agreements. Because these funds are from multiyear
appropriations, ARS has not completely spent the payments received in
fiscal year 2005.
[End of table]
Finally, a senior ARS official expressed concern that because of
current funding constraints, research at Plum Island does not address
other emerging livestock diseases. This official stated that
researching other diseases would mitigate some of the uncertainty and
better prepare animal health responders, such as veterinarians, to
respond to the unknown. In particular, this official emphasized the
importance of developing expertise in other foreign animal diseases.
Experts Regard FMD as the Most Significant Threat but Raised Concerns
about Focusing Limited Resources on a Single Disease:
Nationally recognized animal disease experts we interviewed agreed that
FMD constitutes the greatest threat to American livestock, and, as
such, warrants increased attention. Therefore, most of the experts
agreed that it is prudent to marshal resources to study FMD at Plum
Island. Most of the experts also found it reasonable to terminate
research on diseases of lesser importance to the U.S. economy, such as
African swine fever. However, all of the experts questioned the wisdom
of focusing limited resources almost exclusively on a single disease.
Several experts also expressed concern that the focus on a single
disease will constrain the development of expertise in other critical
diseases, exacerbating the current shortage of talent in this area. For
example, one expert told us that there is a shortage of people with an
interest in developing expertise in high-priority foreign animal
diseases.
In fact, nearly all of the experts we interviewed believed that the
current work at Plum Island does not adequately address the potential
threats posed by deliberate and accidental introductions of foreign
animal diseases other than FMD. Specifically, all but one of the
experts we consulted said that focusing research on a single disease
makes livestock more vulnerable to the diseases that are not being
studied to the same extent, or in some cases, at all, such as Nipah
virus. Many of these experts emphasized that because it is difficult to
predict foreign animal disease outbreaks, it is important to maintain
ongoing research on a range of diseases to be better prepared. As a
related example, one scientist pointed out that because little was
known about West Nile virus, officials were unprepared when the first
outbreak occurred in the United States in 1999. West Nile is a disease
that can be fatal to humans, horses, and birds. The first case of West
Nile virus in the United States was detected in New York, and the
disease spread to an additional 48 states by 2003. An ARS official
acknowledged the limitations of focusing research on a single disease
and commented that ARS would like to do more research on emerging
diseases to be better prepared for the unknown. DHS and ARS officials
caution that resource and facility constraints would make it difficult
to expand the current research portfolio at Plum Island. Also, such a
portfolio would require significantly more stringent biosecurity than
is currently in place at the island if research were performed on
diseases that could affect both animals and humans.
Some diseases of concern that are not currently being studied at Plum
Island include Nipah virus and Rift Valley fever.[Footnote 15] Members
of a blue-ribbon threat assessment panel pinpoint these diseases, which
affect both humans and livestock, as warranting greater attention
because an outbreak could result in economic disruption or interfere
with trade. Some of the experts we interviewed also said that Rift
Valley fever research is needed. Research conducted outside of Plum
Island on Nipah virus and Rift Valley fever is very limited. At the DHS-
funded Center of Excellence at Texas A&M University there are plans to
develop a vaccine for Rift Valley fever, but there is limited
laboratory space to conduct this type of work on large animals and,
therefore, researchers at the center cannot test the vaccine on large
animals.[Footnote 16] The Texas A&M Center of Excellence anticipates
that it will rely on institutions overseas, such as the Onderstepoort
laboratories in South Africa, to conduct such tests.
DHS and USDA officials told us that in order to study Rift Valley fever
on large animals at Plum Island, individuals involved with the research
would require a vaccination. Alternatively, Plum Island would need to
enhance its biosafety procedures to comply with the stricter biosafety
level 4 standards.[Footnote 17] A DHS official noted that at the time
of the transfer of Plum Island, the Homeland Security Secretary pledged
to the nearby communities that DHS would not seek a more stringent
biosafety designation for the facility.
Other experts commented on other factors that limit research on foreign
animal diseases. For example, one expert commented that while Plum
Island plays a critical role in the national effort to address foreign
animal diseases, researchers at this facility cannot study every
foreign animal disease of concern, especially given the resource
constraints and that the staff do not have expertise in other diseases,
such as vector-borne diseases. This expert believes that collaborations
between Plum Island and other research institutions would benefit the
United States by enhancing the nation's knowledge in areas that
researchers would otherwise not be able to address at Plum Island.
Several experts suggested that DHS and USDA might use the Plum Island
facility more effectively by limiting its research agenda to live
infectious agents that can be studied only there and allowing other
institutions to perform the work that does not require the stringent
safety features of Plum Island. For example, researchers in other
institutions could develop vaccines without using a live form of
infectious agents or model disease outbreaks. One expert told us that
researchers could answer questions through modeling and risk assessment
that would be based on the data generated from tests using animals at
Plum Island.
Another way to maximize space resources at Plum Island may be to shift
work on domestic animal diseases off the island. An expert we consulted
said that doing this work at Plum Island decreases the island's already
limited resources available to study foreign animal diseases. For
example, this expert regards vesicular stomatitis--a disease often
mistaken for FMD--as inappropriate for Plum Island because it is a
domestic disease and is not highly contagious. Other experts
highlighted the value of studying this disease--in part to provide
researchers or responders with experience in distinguishing this
domestic disease from FMD--but some noted that it might be more
appropriate to study it in other laboratories in the mainland United
States. USDA commented that it is necessary for the agency to conduct
its research on vesicular stomatitis at Plum Island because scientists
are working with samples that may be contaminated with FMD. In
addition, USDA commented that another benefit from maintaining research
on vesicular stomatitis at Plum Island is that such work enables the
agency to retain staff trained to work with diseases that affect humans
and animals. DHS officials stated that, in their opinion, this type of
work constitutes a minimal percentage of Plum Island's workload; a
senior ARS official concurred and estimated that this work accounts for
roughly 5 percent of the ARS research funds at Plum Island.
According to DHS, the agency is exploring opportunities to involve
other research institutions. For example, the DHS officials noted that
recently Plum Island officials have begun to assess what work could be
moved off the island to other research facilities while taking into
consideration what parts of the combined research tasks can be possibly
conducted off of the island.[Footnote 18] A DHS official told us that
the agency has tapped Lawrence Livermore National Laboratory to
coordinate closely with Plum Island researchers and develop diagnostic
and detection tools for FMD, and demonstrate the performance of such
tools in the field. Also, a researcher at the DHS Center of Excellence
at Texas A&M stated that the center is investigating genetic methods
for preventing FMD, deferring portions of the research requiring use of
the live virus to Plum Island; there, a smaller team can handle the
virus in a laboratory setting that meets the stringent safety
standards. Finally, USDA commented that ARS has established
collaborative relationships with eight universities and two other
institutions to accomplish its research mission.
APHIS's Priorities Remain the Same, but Budget Changes Curtailed the
Planned Expansion of Diagnostic Services:
According to APHIS officials, before the transfer of Plum Island to
DHS, they expected to receive a $2.3 million increase in funding, which
Congress had approved in February 2003 as part of the agency's
appropriations. APHIS was expecting this increased funding to meet
rising demand for diagnostic services. Specifically, the 2001 FMD
outbreak in the United Kingdom and the emphasis on bioterrorism
prompted a shift from passive foreign animal disease surveillance to a
more active approach. These events underscored the need for additional
staff. In addition, APHIS had assumed responsibility for establishing
the validity of rapid diagnostic tools to be used by scientists in a
national network of state veterinary laboratories.[Footnote 19]
However, APHIS officials told us that as a result of the transfer, the
$2.3 million increase that APHIS officials were expecting to receive
was not fully realized.[Footnote 20] According to budget documents,
APHIS had expected to allocate a total of $4.3 million in fiscal year
2004 to diagnostic work at Plum Island, which included the $2.3
million. Instead, half of this amount--$2.1 million--was allocated to
the DHS budget for Plum Island that year. OMB decided to use the APHIS
fiscal year 2003 budget allocation--which included the $2.3 million--as
a base to determine how much money APHIS and DHS should receive in
fiscal year 2004.[Footnote 21] Additionally, OMB transferred a portion
of APHIS's fiscal year 2003 programmatic funds (about $332,000) to
cover DHS's new responsibility for operations and maintenance at Plum
Island. This change in fiscal year 2003 funding for APHIS occurred
because the Homeland Security Act authorized the President to establish
initial funding for DHS by transferring funds from other
agencies.[Footnote 22] Although APHIS officials understood that APHIS's
budget for Plum Island would decrease when operations and maintenance
funds were allocated to DHS, they did not expect this further reduction
in programmatic funds.
APHIS officials noted that although they remain committed to the same
diagnostic priorities at Plum Island, the transfer to DHS has strained
their diagnostic capabilities at Plum Island. They said their plans to
hire more scientists and train more veterinarians to recognize foreign
animal diseases were seriously curtailed because they did not receive
the anticipated increase. The officials told us that anticipated
enhancements to the diagnostic tools at Plum Island would have
facilitated a faster response to an outbreak. In fact, an APHIS
official told us that, at current funding levels, APHIS staff are able
to focus only on validating tests for the highest-priority diseases,
such as FMD, and that APHIS lacks the staff and resources to develop
tests for other high-priority diseases, such as Rift Valley fever and
other emerging diseases. APHIS officials concluded that Plum Island,
which is the only place in the United States where hands-on training on
high-priority foreign animal diseases affecting livestock can be
provided, lacks the capacity to accommodate the increased demand for
such training. DHS officials noted that, since assuming responsibility
for Plum Island, the agency has funded a pilot program to provide
distance learning via audiovisual equipment. While the distance
training does not provide students with the desirable hands-on
experience of observing and diagnosing foreign animal diseases, DHS
stated that this tool has augmented the capability of the Foreign
Animal Disease Diagnostician Course by providing instruction to
practitioners in locations beyond Plum Island.
Figure 4: Veterinarians Participate in Training on Foreign Animal
Diseases at Plum Island:
[See PDF for image]
[End of figure]
Though APHIS funding was reduced after the transfer, DHS has reimbursed
APHIS to perform diagnostic work at Plum Island in fiscal years 2004
and 2005.[Footnote 23] For example, in fiscal year 2004, DHS and APHIS
negotiated an Economy Act agreement that enabled APHIS to retain eight
new scientists--a key step in carrying out its planned expansion of
diagnostic services. This agreement covered salary and benefits for
eight new APHIS employees rather than ongoing APHIS program costs at
Plum Island. The sum of the 2004 DHS reimbursement and the 2004
allocation to the APHIS laboratory at Plum Island are roughly
equivalent to the APHIS program budget in the fiscal year before the
transfer. However, APHIS officials do not view these reimbursements--
referred to as Economy Act agreements--as an appropriate way to fund
the agency's diagnostic work. These officials said that the purpose of
the agreements was "to avoid duplicating functions" performed by the
agencies at Plum Island, such as caring for the animals, and noted that
they do not expect to negotiate additional agreements directly related
to the planned expansion. Because the reimbursements obtained through
Economy Act agreements have decreased in 2005 and recent congressional
appropriations have not been sufficient to support the additional eight
scientists, APHIS officials expressed concern about the agency's
ability to retain these scientists. DHS officials concurred with
APHIS's view that Economy Act agreements are not an appropriate way to
fund the agency's diagnostic work at Plum Island.
Table 2 summarizes the net effect of the budget reductions and
subsequent funding received through interagency agreements on APHIS's
overall resources at Plum Island for fiscal years 2002 through 2005.
Table 2: APHIS Plum Island Funding, Fiscal Years 2002-2005:
Dollars in millions.
Total allocated funds[A];
2002: $5.9;
2003: $7.1;
2004: $1.7;
2005: $2.5.
Operations and maintenance;
2002: $4.7;
2003: $4.9;
2004: $0;
2005: $0.
Program funds;
2002: $1.1;
2003: $2.2;
2004: $1.7;
2005: $2.5[B].
Department of Defense supplemental funds[C];
2002: $1.45[C];
2003: $1.0[C];
2004: [C];
2005: [C].
Funds transferred to DHS;
2002: [D];
2003: ($0.332);
2004: [D];
2005: [D].
Reimbursable interagency agreements;
2002: [E];
2003: [E];
2004: $1.7[F];
2005: $0.473.
Sum of net program funds and reimbursements received;
2002: $2.7;
2003: $2.9;
2004: $3.4;
2005: $3.0.
Source: GAO analysis of APHIS data.
[A] Includes funding for programmatic activities as well as for
operations and maintenance. APHIS was not responsible for maintenance
and operations costs at the facility after the transfer to DHS.
[B] According to USDA, the fiscal year 2005 program funds increased
only because the agency redirected funds from other facilities within
the National Veterinary Services Laboratories to Plum Island.
[C] The fiscal year 2002 Department of Defense supplemental funding was
directed to APHIS at Plum Island. Of the total ($2.45 million),
$450,000 was used for classical swine fever testing in fiscal year
2002. The remaining portion had to be used for the FMD vaccine bank ($1
million in fiscal year 2002 and $1 million in fiscal year 2003; these
funds were not available for fiscal years 2004 and 2005).
[D] The direct transfer of funds occurred only in fiscal year 2003.
[E] Refers to the payments APHIS received from DHS through Economy Act
agreements.
[F] USDA officials understood the payments received in fiscal year 2004
were a partial replacement for funds not received and were intended to
cover salaries for APHIS staff at Plum Island.
[End of table]
DHS Continues to Address Infrastructure Needs and Develop Programs
Addressing Its Bioterrorism Priorities at Plum Island:
As discussed elsewhere in this report, DHS has assumed responsibility
for operations and maintenance at Plum Island and has developed its own
applied research program. As part of the 2003 transfer authorized by
the President, DHS received approximately $33 million for building and
facility funds from ARS and APHIS. In addition to the routine
operations and maintenance needs at the facility, the DHS budget at
Plum Island includes funds that allow the agency to conduct major
infrastructure improvements at the facility. External assessments of
the Plum Island facility as well as the agency's own evaluation
revealed safety and security issues that the agency needed to resolve.
DHS's budget included $5.9 million in fiscal year 2004 and $12.9
million in fiscal year 2005 to conduct these improvements at the
facility, such as the installation of closed-circuit television
surveillance to control and monitor access to the containment area in
the laboratory. DHS officials told us that the security and safety
upgrades at Plum Island have increased the funding needs to operate the
facility.
The programmatic funds for DHS--which support the agency's applied
research science and agricultural forensics work--accounted for $8.3
million of the $51 million total allocated to the agency for Plum
Island in fiscal year 2005. As of August 2005, DHS's applied research
science team--which focuses primarily on developing vaccines for FMD--
included seven scientists and support staff. DHS has also used its
programmatic funds to establish a bioforensics laboratory at Plum
Island, which will, according to the agency, validate forensic assays
for FMD as well as classical swine fever.
DHS and USDA Are in the Process of Assessing Long-Term Plans for Joint
Work at Plum Island:
DHS and USDA officials will continue to pursue their current agreed-
upon joint activities, which focus on FMD, and they are assessing
longer-term objectives for future joint work at Plum Island or
elsewhere. Agency officials did not consider it prudent to speculate on
long-term objectives of joint work, in part, because DHS plans to
replace the existing Plum Island facility, and aspects of the new
facility have not yet been determined.
Although DHS and USDA officials told us they plan to continue to work
together on FMD, they are currently assessing the longer-term
objectives of future joint work at Plum Island or elsewhere. DHS and
USDA have established FMD as the immediate top priority for Plum
Island, but they have not yet identified which diseases, if any, they
will address together after FMD. In fact, the Joint Strategy provides a
blueprint for coordinating efforts to address FMD but does not
currently address work on other diseases.[Footnote 24] DHS officials
told us that the agency remains committed to studying the highest-
priority livestock diseases at Plum Island and will decide which
diseases to study based on a scientific assessment of the highest
threats. DHS and USDA officials confirmed that if they decide to
conduct joint activities on other diseases, they will rely on the Joint
Strategy and the mechanisms they established to implement this
strategy--such as the Board of Directors--to coordinate the effort.
DHS officials emphasized that the dynamic nature of threat assessments
makes it difficult to firmly commit to long-term priorities because
information and research needs may change frequently depending on the
nature of the threat. In terms of USDA research priorities, ARS will
establish its research objectives for the next 5 years at the 2005
National Program review and assessment. An ARS official told us that in
the near term, the agency would like to conduct more work on classical
swine fever, though not at the expense of FMD research. This official
noted that no decisions have been made as to whether DHS will
coordinate with ARS to address classical swine fever, and that the work
on this disease has not yet advanced to a stage that would involve DHS
and its applied research capabilities.
Several of the experts we interviewed agreed that, currently, the
prioritization of foreign animal disease threats produces the same
ranking of diseases whether the threat is based on an accidental or a
deliberate introduction; therefore, the experts stated that the current
focus on FMD addresses the disease posing the greatest threat through
both accidental and intentional introduction. However, the rise of new
threats may disrupt the alignment of the agencies' priorities and, in
turn, affect the possibility of joint activities. For example, one top
ARS official told us that the agencies' research and diagnostic
priorities at Plum Island may not continue to be so closely aligned in
the future because, in his view, the agencies have different missions.
DHS officials noted that the agencies' missions are, in fact, closely
aligned because DHS is also responsible for protecting against the
accidental introduction of foreign diseases. They also noted that the
agency's ranking of diseases would follow a formal risk analysis to
prioritize foreign animal diseases based on threat. Based on our
analysis of documents such as the Joint Strategy for Plum Island, we
believe that DHS's mission to protect agriculture is more oriented
toward intentional attacks on agriculture, and, therefore, we expect
the agency will continue to focus more on diseases that could be
introduced deliberately than on diseases that could accidentally break
out in the United States.
Furthermore, officials told us it is premature to firmly commit to long-
term objectives of joint work at Plum Island, in part, because DHS has
plans to replace the existing facility with a new, modernized facility.
Recognizing the shortcomings of the laboratory facilities at Plum
Island--insufficient space and outdated infrastructure--a senior DHS
official told us the agency will construct this facility, pending
congressional approval, to expand its capabilities to defend the
nation's agricultural infrastructure against terrorist attacks. DHS
officials told us, however, that they have not yet determined the scope
of the work to be performed at this new facility, or the facility's
size or location--whether Plum Island or elsewhere--and do not know the
extent to which the new facility will carry out the current mission of
Plum Island. For example, DHS officials told us the agency has not
determined whether the new facility will address such research gaps as
the lack of an approved laboratory to study highly contagious viruses
like Nipah virus, which require higher biosecurity standards than those
in place at Plum Island.
Some DHS and USDA officials speculated that the existing ARS and APHIS
programs at Plum Island would move with the DHS applied research
program to the new facility, but regardless of the facility's location,
the agencies are considering their options. DHS has convened a
scientific working group, including representatives from DHS, ARS,
APHIS, and the Department of Health and Human Services, to discuss the
options for a new facility. DHS estimates that, pending congressional
approval, it will become fully operational by 2012.
Conclusions:
Although quite successful in terms of interagency cooperation, the
transfer of Plum Island from USDA to DHS highlights the challenges that
the agencies face in meeting diagnostic and research needs with
available resources. The limits on funding and on the availability of
laboratory space at Plum Island underscore the importance of leveraging
available resources and expertise elsewhere in the country. While Plum
Island is the only facility in the United States where scientists are
currently authorized to study diseases using certain highly contagious
pathogens in large animals, other important work related to these
diseases could be conducted in other institutions. As DHS evaluates the
size and capabilities of the new foreign animal disease facility that
the agency estimates will be completed by 2012, it will be important to
explore the cost-effectiveness of shifting some current work, such as
research that does not involve the use of live agents, to other
laboratories and reserve the limited laboratory space at Plum Island
for work that can only be performed in that facility.
Recommendation for Executive Action:
To make more effective use of Plum Island's limited laboratory space in
the short term, we recommend that DHS's Science and Technology
Directorate, in consultation with USDA's Agricultural Research Service
and the Animal and Plant Health Inspection Service, pursue
opportunities to shift work that does not require the unique features
of Plum Island to other institutions and research centers.
Agency Comments:
We provided a draft of this report to DHS and USDA for their review and
comment.
DHS generally concurred with the report and said that it accurately
reflects the current relationships and coordination between DHS and
USDA at Plum Island. DHS also agreed with the recommendation and said
the agencies have already addressed the issue. For example, DHS
commented that the agency's assessment--currently under way--of
laboratory and animal room requirements at Plum Island includes
addressing the agencies' options for shifting work to institutions off
of the island. While we view the steps DHS has taken toward
implementing the recommendation as positive, the agency has not
completed these tasks. We believe that DHS needs to consult with USDA
and conduct more work to demonstrate consideration of opportunities to
shift work elsewhere. DHS also provided technical comments, which we
incorporated, as appropriate. DHS's written comments and our detailed
response appear in appendix IV.
USDA generally agreed with the recommendation and found the report to
be factual and generally positive in recognizing the coordination of
activities between DHS and USDA. USDA commented that it would continue
to evaluate the working relationship with DHS. USDA also provided some
clarifying points. For example, USDA noted that while ARS had to reduce
efforts on classical swine fever because of budget reductions, it has
made significant advances toward the development of a marker vaccine
for classical swine fever. USDA also elaborated on our discussion of
vesicular stomatitis virus research, and clarified the benefits of
conducting such work at Plum Island. Finally, USDA stated that while
the recommendation is sound and supported by the agency, the
recommendation could be misleading because little of the work can be
performed elsewhere and it would be difficult to transfer such work. We
have incorporated the clarifications, as appropriate. We also note that
although work done at Plum Island that does not require containment may
not be easily removed or relocated, it is an important step to take in
order to use the facility's limited resources effectively and to be
prepared to respond to outbreaks of various foreign animal diseases.
USDA also provided technical comments, which we incorporated, as
appropriate. USDA's written comments and our detailed response appear
in appendix V.
We are sending copies of this report to the appropriate congressional
committees, the Secretaries of Homeland Security and Agriculture, and
other interested parties. We will also make copies available to others
upon request. In addition, the report will be available at no charge on
the GAO Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please
contact me at (202) 512-3841 or [Hyperlink, robinsonr@gao.gov]. Contact
points for our Offices of Congressional Relations and Public Affairs
may be found on the last page of this report. GAO staff who made key
contributions to this report are listed in appendix VI.
Signed by:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
[End of section]
Appendixes:
Appendix I: Scope and Methodology:
To determine how the Department of Homeland Security (DHS) and the U.S.
Department of Agriculture (USDA) coordinate research and diagnostic
activities at Plum Island, we analyzed DHS and USDA joint strategy
documents, including an interagency agreement between DHS and USDA for
Plum Island, the Joint DHS and USDA Strategy for Foreign Animal Disease
Research and Diagnostic Programs, and the Plum Island Animal Disease
Center Charter. In addition, we reviewed Homeland Security Presidential
Directives 9 and 10 to understand the roles for DHS and USDA in
addressing the threat of agricultural terrorism. We interviewed
officials at various levels from each agency, including senior
leadership officials based in Washington, D.C., the facility's on-site
leadership, and, during a visit to Plum Island, all of the lead
scientists. We also interviewed former USDA scientists who have left
Plum Island since its transfer to DHS on June 1, 2003.
To determine what changes, if any, have taken place regarding research
and diagnostic priorities at Plum Island since the facility was
transferred to DHS, and the reasons for and implications of such
changes, we interviewed the current and two former Plum Island
directors, spoke with current and former Plum Island scientists, and
discussed research and diagnostic priorities with senior officials in
the DHS Science and Technology Directorate and USDA's Agricultural
Research Service (ARS) and Animal and Plant Health and Inspection
Service (APHIS). To understand Plum Island's budget, we also
interviewed analysts and officials at the agencies and at the White
House Office of Management and Budget, which developed and oversaw the
DHS budget during the creation of the agency. In addition, we analyzed
agency budget documents for fiscal years 2002 through 2006 to identify
changes in funding levels before and after the transfer of Plum Island
and to determine the funding allocations among the programs at Plum
Island.
We also conducted structured interviews in person or via telephone with
recognized nongovernment experts from academic and other research
organizations that we chose for their diverse perspectives and
technical expertise on animal health and diseases.[Footnote 25] In
particular, we sought to obtain their comments on research and
diagnostic priorities at Plum Island. We based our initial selection of
experts on a list of stakeholders invited to participate in the ARS's
National Program Review Workshop, which met on September 20-21, 2005,
in Kansas City, Missouri, to provide feedback on ARS priorities and
national research programs. From the list of workshop participants, we
identified 13 stakeholders who do not work at Plum Island and who study
foreign animal diseases or serve as members in organizations that
address foreign animal diseases. This list included some recognized
experts who have served on reputable committees assessing the threats
of animal diseases, including the White House Office of Science and
Technology Policy Blue Ribbon Panel on the Threat of Biological
Terrorism Directed Against Livestock. We identified an additional two
contacts through referrals from these stakeholders. From these 15
contacts, we selected the final 11 experts on the basis of the
following criteria: (1) recommendations we received from others
knowledgeable in the field of foreign animal diseases; (2) area of
expertise and experience; and (3) type of organization represented,
including academic institutions and associated research centers.
To examine the long-term objectives of joint activities at Plum Island,
we analyzed agency planning documents and interviewed senior leadership
officials representing DHS and USDA. We also discussed with DHS and
USDA officials the status and possible outcomes of a DHS feasibility
study to upgrade the Plum Island Animal Disease Center.
We conducted our review from March 2005 to December 2005 in accordance
with generally accepted government auditing standards.
[End of section]
Appendix II: List of Experts Interviewed:
* Roger Breeze, Ph.D., M.R.C.V.S. Chief Executive Officer, Centaur
Science Group, Washington, D.C. Former Director, Plum Island Animal
Disease Center.[Footnote 26]
* Corrie Brown, Ph.D., D.V.M. Professor and Coordinator of
International Activities, Department of Veterinary Medicine, University
of Georgia, Athens, Georgia.[Footnote 27]
* Neville Clarke, Ph.D., D.V.M. Director, National Center for Foreign
Animal and Zoonotic Disease Defense, College Station, Texas.
* Peter Cowen, Ph.D., D.V.M., M.P.V.M. Associate Professor of
Epidemiology and Public Health, Department of Population Health and
Pathobiology, College of Veterinary Medicine, North Carolina State
University, Raleigh, North Carolina.
* Linda L. Logan, Ph.D., D.V.M. USDA APHIS Attache serving North
Africa, East Africa, the Middle East and the Near East, Cairo,
Egypt.[Footnote 28]
* Peter W. Mason, Ph.D. Professor of Pathology, Professor of
Microbiology and Immunology; Senior Scientist, Sealy Center for Vaccine
Development; member, Center for Biodefense and Emerging Infectious
Diseases, University of Texas Medical Branch, Galveston, Texas.
* James A. Roth, Ph.D., D.V.M. Distinguished Professor of Immunology;
Assistant Dean, International Programs and Public Policy; and Director,
Center for Food Security and Public Health, College of Veterinary
Medicine, Iowa State University, Ames, Iowa.
* M.D. Salman, Ph.D., M.P.V.M., D.A.C.V.P.M., F.A.C.E. Professor and
Director of Animal Population Health Institute, College of Veterinary
Medicine and Biomedical Sciences, Colorado State University, Fort
Collins, Colorado.[Footnote 29]
* Mark C. Thurmond, Ph.D., D.V.M. Professor, Department of Medicine and
Epidemiology, University of California, Davis, California.
* Alfonso Torres, Ph.D., D.V.M. Executive Director, New York State
Animal Health Diagnostic Laboratory, and Associate Dean for Veterinary
Public Policy, College of Veterinary Medicine, Cornell University,
Ithaca, New York.
* David H. Zeman, Ph.D., D.V.M. Department Head, Veterinary Science
Department; Director, Animal Disease Research and Diagnostic
Laboratory; and Director, Olson Biochemistry Laboratories, South Dakota
State University, Brookings, South Dakota.
We also sought the perspective of agricultural producers:
* Gary Weber, Ph.D. Executive Director, Regulatory Affairs, National
Cattlemen's Beef Association, Washington, D.C; and:
* National Pork Board.[Footnote 30]
[End of section]
Appendix III: Animal Diseases That Affect Livestock:
The table below presents information about key aspects of animal
diseases that can affect livestock mentioned in the report, including
the animals affected, transmission route, and vaccine ability.
Table 3: List of Animal Diseases:
Diseases and agents: African swine fever;
Animals affected: Domestic and wild pigs, wart hogs;
Route of transmission: Direct contact with body fluids, especially
blood; fomites; tick vectors;
Distribution: Africa;
Availability of vaccine: No;
Can affect humans: No.
Diseases and agents: Brucellosis;
Animals affected: Main threat to cattle, bison, and swine;
Route of transmission: Direct contact;
Distribution: Worldwide;
Availability of vaccine: Yes;
Can affect humans: Yes.
Diseases and agents: Classical swine fever;
Animals affected: Domestic pigs;
Route of transmission: Ingestion (uncooked garbage); fomites; aerosol;
direct contact;
Distribution: Africa, Asia, Europe, South America;
Availability of vaccine: Yes;
Can affect humans: No.
Diseases and agents: Foot-and-mouth disease;
Animals affected: All cloven hoofed animals, including cattle, sheep,
goats, pigs;
Route of transmission: Aerosol; direct contact; ingestion; fomites;
Distribution: Africa, Asia, Middle East, South America;
Availability of vaccine: Yes;
Can affect humans: Yes, but rarely infects humans.
Diseases and agents: Nipah virus;
Animals affected: Pigs, horses, cats, dogs;
Route of transmission: Close direct contact with contaminated tissue or
body fluids;
Distribution: Southeast Asia;
Availability of vaccine: No;
Can affect humans: Yes.
Diseases and agents: Rift Valley fever;
Animals affected: Cattle, sheep, goats, dogs, cats, camels, monkeys;
Route of transmission: Insect vectors (mosquitoes); direct contact with
blood or tissue;
Distribution: Africa;
Availability of vaccine: Yes;
Can affect humans: Yes.
Diseases and agents: Rinderpest;
Animals affected: Cattle, sheep, goats;
Route of transmission: Direct or close contact with body fluids;
Distribution: Indian subcontinent, Near East, sub-Sahara;
Availability of vaccine: Yes;
Can affect humans: No.
Diseases and agents: Sheep and goat pox;
Animals affected: Sheep, goats;
Route of transmission: Aerosol; direct contact, fomites, mechanically
by arthropods;
Distribution: Africa, Asia, Middle East;
Availability of vaccine: Yes;
Can affect humans: No.
Diseases and agents: Vesicular stomatitis;
Animals affected: Horses, donkeys, mules, cattle, pigs;
Route of transmission: Insect vectors, direct contact, fomites,
aerosol;
Distribution: North and Central America, Northern part of South
America;
Availability of vaccine: Yes;
Can affect humans: Yes.
Diseases and agents: West Nile virus;
Animals affected: Birds, many mammals, reptiles;
Route of transmission: Mosquito vectors;
Distribution: Africa, Asia, Europe, Middle East, North America;
Availability of vaccine: Yes (for prevention in horses);
Can affect humans: Yes.
Source: GAO.
[End of table]
[End of section]
Appendix IV: Comments from the Department of Homeland Security:
U.S. Department of Homeland Security:
Washington, DC 20528:
November 22, 2005:
Mr. Robert A. Robinson:
Managing Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Robinson:
Thank you for the opportunity to comment on draft report GAO-06-132,
Plum Island Animal Disease Center: DHS and USDA Are Successfully
Coordinating Current Work, but Long-Term Plans Are Being Assessed.
Technical comments have been provided under separate cover.
Overall, the report accurately reflects the current relationships and
coordination that have been established between the Department of
Homeland Security's (DHS's) and the United States Department of
Agriculture's (USDA's) personnel and programs at the Plum Island Animal
Disease Center (PIADC). DHS agrees with the recommendation to make
maximum use of the limited laboratory space by conducting work on the
Island that uniquely needs to be accomplished on the Island.
There are several references to the scope of the DHS research program
for vaccines being limited to foot and mouth disease. It should be
noted that in FY2006, DHS funds are also being allocated to Rift Valley
fever vaccine development. This work will be directed by staff at Plum
Island but will not be conducted at Plum Island.
In reference to the report's analysis that "our mission to protect
agriculture is more oriented toward intentional attacks on agriculture"
and that we will not be looking at diseases that could accidentally
break out, we would like to point out that the Department's mission
includes, as stated in the Homeland Security Presidential
Directive/HSPD9 Defense of United States Agriculture and Food, that DHS
is responsible for "coordinating the overall national effort to enhance
the protection of critical infrastructure and key resources of the
United States." In such a role, it is important for DHS not only to
enhance protection against intentional attacks but also against major
disease outbreaks that could severely impact agriculture
infrastructure, the food supply or the economy. This risk-based
approach to all high consequence threats allows DHS to focus on those
areas that are most critical.
With regard to the report's recommendation to pursue opportunities to
shift work that does not require the stringent biosafety features of
Plum Island to other institutions and research centers, DHS and USDA
have already worked to address this issue. At the very first PIADC
Board of Directors meeting in December 2004, the attendees discussed
determining how best to safely ensure both maximum flexibility and a
timely decision making process. In response to this discussion, USDA's
Animal and Plant Health Inspection Service (APHIS) revised the charter
of its Emergency Management Leadership Team (EMLT) to include this
capability within its duties. The EMLT meets regularly and will be able
to rapidly process requests from any of the agencies at Plum Island or
other research groups.
In addition, the Senior Leadership Group (SLG) at PIADC has instituted
an animal room reservation system that allows the SLG to review
proposed projects and ensure the best use of the current rooms. In case
of limitations on space, part of this review would include an analysis
as to whether the work could be done in another location.
DHS also has underway an assessment of laboratory and animal room
requirements for USDA's Agricultural Research Service, APHIS and DHS
for the next six years (2006-2011) on a project basis. Part of this
assessment includes addressing each organization's options for
performance off-island through other facilities, contract research
organizations, other countries, etc.
Consequently, we believe this recommendation for executive action has
already been addressed and request that it not be included in the final
report as we consider this issue closed.
Thank you again for the opportunity to comment on this draft report and
we look forward to working with you on future homeland security issues.
Sincerely,
Steven J. Pecinovsky:
Director:
Departmental GAO/OIG Liaison Office:
The following are GAO's comments on the Department of Homeland
Security's letter dated November 22, 2005.
GAO Comments:
1. Regarding DHS's comment that the scope of its research program is
not limited to FMD, our report notes that the DHS-funded Center of
Excellence has plans to develop a vaccine for Rift Valley fever. In
addition, we have modified the report to include a statement that DHS
funds are being allocated to the development of a vaccine for Rift
Valley fever in fiscal year 2006.
2. Regarding DHS's assertion that its mission includes enhancing
protection against major disease outbreaks, our report states that
DHS's mission to protect agriculture includes responsibilities to
address introductions of high consequence foreign animal diseases that
could be either deliberately or accidentally introduced. However, we
continue to believe that DHS's mission to protect agriculture is more
oriented toward intentional attacks on agriculture. First, the Homeland
Security Act of 2002 states that DHS's primary mission is to prevent
terrorist attacks within the United States.[Footnote 31] Second, the
information DHS provided about its role at Plum Island has emphasized
deliberate introductions. For example, the Joint Strategy emphasizes
the bioterrorism focus of DHS work at Plum Island in describing the
agency's mission "to conduct, stimulate, and enable research and
development to prevent or mitigate the effects of catastrophic
terrorism." The Joint Strategy also states that DHS will "focus on
identified research and development gaps specifically targeted to
strengthen the nation's ability to anticipate, prevent, respond to, and
recover from the intentional introduction of a high consequence foreign
animal disease."
3. Although DHS said that the Board of Directors meetings included a
discussion of what work could be conducted off the island, USDA
officials disagree with this statement. Furthermore, while we
understand that the Board of Directors has met on several occasions, we
do not have evidence to support that a discussion about maximizing
space resources occurred at the meeting. We also have not seen an
outcome of discussions regarding shifting work to other institutions.
4. Regarding DHS's comment that the Senior Leadership Group has
instituted a room reservation system that takes into consideration work
that can be shifted elsewhere, our report states that the Senior
Leadership Group has implemented a system to ensure efficient use of
limited space at Plum Island. We have modified the report to note that
in the case of limited space, the Senior Leadership Group would, as
part of its review of the proposed projects, evaluate whether the work
could be done at another location. However, as our report states, space
is already limited at Plum Island, constraining research and diagnostic
work that can be performed at the facility. We have not seen evidence
that this group has formally evaluated the feasibility of shifting work
from Plum Island to other research institutions in order to overcome
resource constraints.
5. We are encouraged to hear that DHS is in the process of assessing
the laboratory and animal room requirements for all three agencies at
Plum Island for the next 6 years and, as part of this assessment, will
address each agency's options for performing activities off of the
island through other facilities, contract research organizations, and
the like. However, because the assessment has not been completed yet,
and we have not seen evidence that DHS is conducting this review in
conjunction with USDA, we continue to believe that the agencies have
not identified opportunities to shift work that does not require the
unique features of Plum Island to other institutions and research
centers.
[End of section]
Appendix V: Comments from the U.S. Department of Agriculture:
USDA:
United States Department of Agriculture:
Research, Education, and Economics:
Agricultural Research Service:
NOV 30 2005:
IN REPLY:
REFER TO: Draft Report GAO-06-132, "Plum Island Animal Disease Center:
DHS and USDA are Successfully Coordinating Current Work, but Long-Term
Plans are Being Assessed" (360562):
Mr. Robert A. Robinson:
Managing Director:
Natural Resources and Environment:
United States Government Accountability Office:
Washington, D.C. 20548:
Dear Mr. Robinson:
On behalf of Agricultural Research Service (ARS) and Animal and Plant
Health Inspection Service (APHIS), we thank you for the opportunity to
review and comment on the subject draft report. We are providing
general comments for your use in preparing the final report and have
submitted technical comments under separate cover.
We sense the report to be factual and generally positive in recognizing
the coordination of activities between the Department of Homeland
Security (DHS) and the Department of Agriculture (USDA). Overall, we
generally agree with the recommendations in the draft report, and will
continue to evaluate the working relationship with DHS and implement
appropriate recommendations and measures of this report as our
resources permit.
We would like to take this opportunity to clarify a few points:
* While ARS has had to reduce efforts on Classical Swine Fever due to
budget reductions, it has made significant advances toward the
development of a marker vaccine for Classical Swine Fever and continues
a significant emphasis on Classical Swine Fever research.
The Vesicular Stomatitis Virus (VSV) research that ARS is carrying out
involves strains from countries such as Brazil, Colombia, Ecuador,
Peru, etc. which have Foot and Mouth Disease (FMD). Because of the
latter research on these VSV strains must be carried out at the Plum
Island Animal Disease Center (PIADC). The report should also mention
that maintaining research on:
VSV provides the capability of maintaining staff that are trained in
working with a zoonotic disease.
If a zoonotic virus were to emerge, it is important to have staff that
are comfortable wearing respirators and other personal protective
equipment and accustomed to following strict BSL-3 procedures.
The impact on the nation's preparedness following the transfer of
programmatic funds from APHIS and ARS to DHS for a related but distinct
area of work is reflected in the report but not in the conclusions. The
loss of diagnostic detection and response capability and research
capacity will need to be replaced.
* The recommendation to shift work that does not require the stringent
biosafety features of Plum Island to other institutions and research
centers while being sound and supported by USDA is misleading. Very
little of what is being done on the Island (in the containment
facility) is work that could be done elsewhere. The "non-BSL-3" work
that is being done in the labs and animal rooms fits so tightly into
the research/diagnostic programs that it could not be easily removed
and relocated.
The report makes several references to "modeling." USDA is not
currently carrying out any modeling activities in the containment
facility. Modeling and the use of killed, engineered, or surrogate
agents off the island is supported by USDA in those situations where
the assurance of biosafety and reliable results is justified. In
addition, currently ARS has formal collaborative relationships with
eight universities and two other institutions in accomplishing its
research mission. As an example, most of the tools used today to
evaluate immune response to FMD vaccines were developed at PIADC in
collaboration with a University of Missouri scientist currently at the
University of Texas Medical Branch.
While concern has been raised about the Department's decision to
prioritize research on foot-and-mouth disease (FMD), it must be
emphasized that FMD is the most economically important single livestock
disease worldwide and perhaps the most contagious. Concern was also
raised about the availability of funds for diagnostic work. The
Department constantly balances multiple needs and takes into
consideration many priorities when preparing its annual budget.
Once again, we appreciate the chance to provide our review and comment
on this draft report.
Sincerely,
Signed for:
EDWARD B. KNIPLING:
Administrator, ARS:
Signed for:
W. RON DEHAVEN:
Administrator, APHIS:
The following are GAO's comments on the U.S. Department of
Agriculture's letter dated November 30, 2005.
GAO Comments:
1. Regarding USDA's comments about ARS's continued focus on classical
swine fever and its advances in developing a marker vaccine for this
disease, our report notes that this disease is a high priority. We
modified the report to include USDA's view that while ARS has had to
reduce efforts on classical swine fever due to budget reductions, it
has made significant advances toward the development of a marker
vaccine for classical swine fever.
2. Regarding USDA's comments about the value of working on vesicular
stomatitis virus at Plum Island, our report summarizes the conflicting
views of experts regarding the need for such work at Plum Island. We
have modified the report to summarize why USDA believes it is important
to maintain research on vesicular stomatitis virus at Plum Island.
3. Regarding USDA's comment on the transfer of programmatic funds from
ARS and APHIS to DHS for a related but distinct area of work, our
report states that after the transfer, there have been increased
demands for the facility's limited space and resources related to
research and diagnostic activities. Our conclusions summarize the
challenges the agencies face in meeting research and diagnostic needs
with available resources, and form the basis of our recommendation that
DHS's Science and Technology Directorate work with USDA's ARS and APHIS
to pursue opportunities to make more effective use of Plum Island's
limited laboratory space.
4. Regarding USDA's comments on the recommendation to pursue
opportunities to shift work that does not require the unique features
of Plum Island to other institutions and research centers, we recognize
that not all such work may be relocated or easily removed. For example,
as our report notes, any work involving a live FMD agent would have to
be conducted at Plum Island. Furthermore, the report states that Plum
Island is the only facility that has special safety features required
to study certain high consequence foreign animal diseases in large
animals. However, we continue to believe that there are opportunities
to shift work to other institutions. For example, experts identified
work that could be done outside of Plum Island, such as developing
vaccines without using the live form of the agents. This work is
important in order to remain prepared to respond to outbreaks of
various foreign animal diseases.
5. Regarding USDA's comment on modeling, we modified our report to
clarify that modeling activity does not occur in containment.
[End of section]
Appendix VI: GAO Contact and Staff Acknowledgments:
GAO Contact:
Robert A. Robinson, (202) 512-3841 or [Hyperlink, robinsonr@gao.gov]:
Staff Acknowledgments:
In addition to the contact named above, Maria Cristina Gobin (Assistant
Director), Kate Cardamone, Nancy Crothers, Mary Denigan-Macauley, Lynn
Musser, Omari Norman, Joshua Smith, and Lisa Vojta made key
contributions to this report. Sharon Caudle, Elizabeth Curda, Denise
Fantone, Terry Horner, Katherine Raheb, Keith Rhodes, and Steve Rossman
also made important contributions.
(360562):
FOOTNOTES
[1] Live FMD virus may be used only at coastal islands such as Plum
Island, unless the Secretary of Agriculture specifically authorizes the
use of the virus on the U.S. mainland. 21 U.S.C. § 113a.
[2] Pub. L. No. 107-296, § 310, 116 Stat. 2135, 2174 (2002), codified
at 6 U.S.C. § 190.
[3] 6 U.S.C. § 542(b)(3).
[4] H.R. Rep. No. 108-792, p. 666 (2004).
[5] USDA conducts research on high-priority diseases affecting animals
besides livestock, such as poultry, at other locations. For example,
diseases like Newcastle disease and avian influenza, which affect
poultry, are studied at USDA's Southeast Poultry Research Laboratory in
Athens, Georgia. USDA's National Animal Disease Center in Ames, Iowa,
studies indigenous diseases of livestock and poultry, including
brucellosis. USDA performs diagnostics on these diseases at the
National Veterinary Services Laboratories in Ames, Iowa.
[6] There is no universal FMD vaccine that is effective for all of the
subtypes of FMD. The United States stockpiles some FMD vaccines at the
North American Foot-and-Mouth Disease Vaccine Bank on Plum Island.
However, these vaccines are not stored in a "ready-to-use" state. That
is, they are stored as a vaccine antigen concentrate that requires
finishing in order to be used.
[7] The interagency agreement is entitled: Interagency Agreement
Between the United States Department of Agriculture and the Department
of Homeland Security for the Plum Island Animal Disease Center. The
agencies review this agreement at least annually.
[8] Diagnostic assays refer to tools used to detect and confirm the
presence of disease, whereas forensic assays include those which could
be used as evidence in a prosecution. Bioforensics is conducted
according to certain protocols such that there is no question about
contamination and the analysis can serve as proof in court.
[9] DHS commented that in the case of limited space, the Senior
Leadership Group would, as part of its review of the proposed projects,
evaluate whether the work could be done at another location.
[10] ARS conducts the National Program review every 5 years to solicit
feedback from agriculture stakeholders to identify and establish the
research objectives for the ARS program. The review process involves a
survey and a series of stakeholder meetings to discuss research
objectives. The stakeholders represent knowledgeable officials in
academia, industry, and the government. At the time of this report
writing--fall of 2005--ARS was preparing to host the 2005 National
Program review.
[11] ARS retained the capacity to sequence viruses in the highest-
priority programs, i.e., FMD and classical swine fever. Sequencing
enables scientists to better understand the genetic code of viruses and
helps to identify and trace the source of diseases. DHS officials noted
that the sequencing equipment is used by both agencies.
[12] Once administered to livestock, a marker vaccine elicits a
protective immunity that can be distinguished from the immune response
elicited by natural infection of the virus. Marker vaccines enable
veterinarians to clearly differentiate between animals infected with a
disease and those that have been vaccinated. This important distinction
would have a significant impact on trade.
[13] USDA has commented that while ARS has had to reduce efforts on
classical swine fever due to budget reductions, it has still made
significant advances toward the development of a marker vaccine for
classical swine fever.
[14] ARS negotiated such agreements with other agencies before the
transfer, but total reimbursements under these agreements increased in
fiscal year 2004.
[15] Nipah virus affects pigs, horses, cats, and dogs, and spreads
readily from pigs to humans with serious effects. Nipah virus causes
serious, and sometimes fatal, encephalitis in humans, and respiratory
and central nervous system disease in swine and other animals. Rift
Valley fever affects primarily livestock, but also causes illness in
humans. Exposure to the Rift Valley fever virus may result in no
symptoms or mild illness, such as fever, or more serious illnesses such
as hemorrhagic fever, encephalitis, and vision problems.
[16] DHS officials told us that funds are being allocated to the
development of a vaccine for Rift Valley fever in fiscal year 2006.
According to DHS, Plum Island staff will direct the work, but it will
not be conducted at Plum Island.
[17] Laboratories adhere to specific biosafety guidelines according to
their designated biosafety level, which can range from 1 to 4.
Biosafety level 1 is acceptable for low-risk organisms that may be
found, for example, in high school laboratories. Biosafety level 4 is
reserved for a number of exotic and highly lethal pathogens, such as
Ebola virus. There are only five facilities in the United States with
biosafety level 4 laboratories, including the Department of the
Defense's U.S. Army Medical Research Institute of Infectious Diseases
and the Department of Health and Human Services' National Institutes of
Health. Plum Island operates a biosafety level 3 agriculture laboratory
with some additional special agricultural safety features to prevent
the release of animal disease pathogens into the environment.
[18] DHS officials told us that discussions regarding coordination of
research and maximization of space resources have occurred at the Board
of Directors meetings. According to ARS, however, program officials
have held such discussions, but not at the level of the Board of
Directors.
[19] DHS officials recently noted that while APHIS will validate rapid
diagnostic tools for foreign animal diseases, DHS is coordinating the
field validation of multiplexed diagnostic assays that include domestic
diseases that can be confused with FMD.
[20] Congress does not appropriate funds directly to the Plum Island
facility, but appropriates a lump sum to APHIS. APHIS in turn allocates
funds to its programs. An APHIS official told us they based the
disbursement on the allocation guidelines recommended in congressional
conference reports.
[21] Over and above funds for facility maintenance and operations,
according to OMB officials, OMB divided program funds equally between
DHS and APHIS.
[22] Pub. L. No. 107-296, § 1502, 116 Stat. 2135, 2308 (2002), codified
at 6 U.S.C. § 542.
[23] DHS and USDA negotiated several reimbursements through Economy Act
agreements in fiscal years 2004 and 2005. The Economy Act of 1932 (31
U.S.C. 1535, as amended) authorizes federal agencies to order goods and
services from other federal agencies when funds are available, it is in
the best interest of the government, and the goods and services cannot
be provided as conveniently and cheaply by private industry. The
Economy Act generally requires reimbursement for goods and services
provided to another agency.
[24] DHS officials noted that the Joint Strategy is being modified.
[25] In addition, we spoke with a USDA APHIS attache as well as the
chief executive officer of a science consulting company that
specializes in threat reduction and disease surveillance and response
systems.
[26] M.R.C.V.S. is a member of the Royal College of Veterinary
Surgeons. Ph.D. is a doctorate of philosophy degree.
[27] D.V.M. is a doctorate of veterinary medicine degree.
[28] Dr. Logan did not speak on behalf of USDA, but answered GAO's
questions based on her professional expertise.
[29] M.P.V.M. is a master of preventive veterinary medicine.
D.A.C.V.P.M. is a diplomat, American College of Veterinary Preventive
Medicine. F.A.C.E. is a fellow, American College of Epidemiology.
[30] While we attempted to contact representatives at the National Pork
Board several times, we did not receive responses to our questions.
[31] Pub. L. No. 107-296, § 101(b), 116 Stat. 2135, 2142 (2002),
codified at 6 U.S.C. § 111(b).
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