Plum Island Animal Disease Center: DHS and USDA Are Successfully
Coordinating Current Work, but Long-Term Plans Are Being Assessed
(19-DEC-05, GAO-06-132).
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.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-06-132
ACCNO: A43497
TITLE: Plum Island Animal Disease Center: DHS and USDA Are
Successfully Coordinating Current Work, but Long-Term Plans Are
Being Assessed
DATE: 12/19/2005
SUBJECT: Agricultural programs
Animal diseases
Disease detection or diagnosis
Facility transfer
Federal agency reorganization
Infectious diseases
Interagency relations
Laboratories
Research and development facilities
Research programs
Livestock
Foot and Mouth Disease
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GAO-06-132
* 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
* Contents
* Results in Brief
* Background
* DHS and USDA Have Successfully Coordinated Research and
Diagnostic Programs at Plum Island
* Joint DHS and USDA Strategy Serves as Basis to Prioritize
and Coordinate Work
* DHS and USDA Rely on Formal and Informal Communication to
Coordinate Activities
* Budget Changes at Time of the Transfer in Part Modified Overall
Priorities and the Scope of Work at Plum Island
* ARS Is Focusing Its Research on FMD, While Other Programs
Were Terminated or Slowed Down Because of Budget Reductions
* Experts Regard FMD as the Most Significant Threat but Raised
Concerns about Focusing Limited Resources on a Single
Disease
* APHIS's Priorities Remain the Same, but Budget Changes
Curtailed the Planned Expansion of Diagnostic Services
* DHS Continues to Address Infrastructure Needs and Develop
Programs Addressing Its Bioterrorism Priorities 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
* Scope and Methodology
* List of Experts Interviewed
* Animal Diseases That Affect Livestock
* Comments from the Department of Homeland Security
* GAO Comments
* Comments from the U.S. Department of Agriculture
* GAO Comments
* GAO Contact and Staff Acknowledgments
* PDF6-Ordering Information.pdf
* Order by Mail or Phone
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
Contents
Tables
Figures
December 19, 2005Letter
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.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.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.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.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.
o 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.
o 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.
o 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.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.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
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:
o 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.
o 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.
o 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
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.
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.
o 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.7
o 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
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.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.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.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.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. 12 An ARS official estimated that the reduced funds for
classical swine fever research will extend the project timeline about 5 to
10 years.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.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
2002 2003 2004 2005
Total allocated fundsa $12.9 $12.7b $4.3 $4.8
Operations and maintenancec 7.1c 4.4c 0 0
Indirect costs c c c 0.560 0.235
Program funds 5.8 8.3 3.7 4.6
Funds allocated to research consortiumd (1.7) (1.8) (1.1) (1.3)
Funds transferred to DHS e (3.2) e e
Reimbursable interagency agreements and other 0.691 0.629 3.7 2.3
sourcesf
Sum of net program funds and reimbursements $4.8 $3.9 $6.3 $5.6
received
Source: GAO analysis of ARS data.
aIncludes 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.
bAmount 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.
cThe 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.
dThe House Appropriations Committee directs ARS to provide these funds
directly to universities participating in a research consortium.
eThe 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.
fRefers 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.
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.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.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.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.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.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.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 2004.21 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.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
Though APHIS funding was reduced after the transfer, DHS has reimbursed
APHIS to perform diagnostic work at Plum Island in fiscal years 2004 and
2005.23 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
2002 2003 2004 2005
Total allocated fundsa $5.9 $7.1 $1.7 $2.5
Operations and maintenance 4.7 4.9 0 0
Program funds 1.1 2.2 1.7 2.5b
Department of Defense supplemental funds c 1.45c 1.0c c c
Funds transferred to DHS d (0.332) d d
Reimbursable interagency agreements e e 1.7f 0.473
Sum of net program funds and reimbursements $2.7 $2.9 $3.4 $3.0
received
Source: GAO analysis of APHIS data.
aIncludes 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.
bAccording 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.
cThe 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).
dThe direct transfer of funds occurred only in fiscal year 2003.
eRefers to the payments APHIS received from DHS through Economy Act
agreements.
fUSDA 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.
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.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 [email protected] . 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.
Robert A. Robinson Managing Director, Natural Resources and Environment
Scope and Methodology Appendix I
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.1 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.
List of Experts Interviewed Appendix II
o 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.1
o Corrie Brown, Ph.D., D.V.M. Professor and Coordinator of International
Activities, Department of Veterinary Medicine, University of Georgia,
Athens, Georgia.2
o Neville Clarke, Ph.D., D.V.M. Director, National Center for Foreign
Animal and Zoonotic Disease Defense, College Station, Texas.
o 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.
o 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.3
o 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.
o 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.
o 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.4
o Mark C. Thurmond, Ph.D., D.V.M. Professor, Department of Medicine and
Epidemiology, University of California, Davis, California.
o 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.
o 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:
o Gary Weber, Ph.D. Executive Director, Regulatory Affairs, National
Cattlemen's Beef Association, Washington, D.C.; and
o National Pork Board.5
Animal Diseases That Affect Livestock Appendix III
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 Animals Route of Distribution Availability Can
agents affected transmission of vaccine affect
humans
African swine Domestic Direct Africa No No
fever and wild contact with
pigs, body fluids,
wart hogs especially
blood;
fomites; tick
vectors
Brucellosis Main Direct Worldwide Yes Yes
threat to contact
cattle,
bison,
and swine
Classical swine Domestic Ingestion Africa, Asia, Yes No
fever pigs (uncooked Europe, South
garbage); America
fomites;
aerosol;
direct
contact
Foot-and-mouth All Aerosol; Africa, Asia, Yes Yes,
disease cloven direct Middle East, but
hoofed contact; South America rarely
animals, ingestion; infects
including fomites humans
cattle,
sheep,
goats,
pigs
Nipah virus Pigs, Close direct Southeast No Yes
horses, contact with Asia
cats, contaminated
dogs tissue or
body fluids
Rift Valley Cattle, Insect Africa Yes Yes
fever sheep, vectors
goats, (mosquitoes);
dogs, direct
cats, contact with
camels, blood or
monkeys tissue
Rinderpest Cattle, Direct or Indian Yes No
sheep, close contact subcontinent,
goats with body Near East,
fluids sub-Sahara
Sheep and goat Sheep, Aerosol; Africa, Asia, Yes No
pox goats direct Middle East
contact,
fomites,
mechanically
by arthropods
Vesicular Horses, Insect North and Yes Yes
stomatitis donkeys, vectors, Central
mules, direct America,
cattle, contact, Northern part
pigs fomites, of South
aerosol America
West Nile virus Birds, Mosquito Africa, Asia, Yes (for Yes
many vectors Europe, prevention
mammals, Middle East, in horses)
reptiles North America
Source: GAO.
Comments from the Department of Homeland Security Appendix IV
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.1
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.
Comments from the U.S. Department of Agriculture Appendix V
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.
GAO Contact and Staff Acknowledgments Appendix VI
Robert A. Robinson, (202) 512-3841 or [email protected]
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)
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
[email protected].
Highlights of GAO-06-132 , a 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
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 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.
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.
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