Plum Island Animal Disease Center: DHS and USDA Are Successfully Coordinating Current Work, but Long-Term Plans Are Being Assessed
Published: 2005-12-19T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. 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. 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.
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. 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.
subsections: section_title: Background
paragraphs: 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. 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.
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.)
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.
section_title: DHS and USDA Have Successfully Coordinated Research and Diagnostic Programs at Plum Island
paragraphs: 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.
subsections: section_title: Joint DHS and USDA Strategy Serves as Basis to Prioritize and Coordinate Work
paragraphs: 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.
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.
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.
section_title: DHS and USDA Rely on Formal and Informal Communication to Coordinate Activities
paragraphs: 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.
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.
section_title: Budget Changes at Time of the Transfer in Part Modified Overall Priorities and the Scope of Work at Plum Island
paragraphs: 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.
subsections: section_title: ARS Is Focusing Its Research on FMD, While Other Programs Were Terminated or Slowed Down Because of Budget Reductions
paragraphs: 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.
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. 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. An  ARS official estimated that the reduced funds for classical swine fever  research will extend the project timeline about 5 to 10 years. 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. 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.
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.
section_title: Experts Regard FMD as the Most Significant Threat but Raised Concerns about Focusing Limited Resources on a Single Disease
paragraphs: 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. 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. 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. 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. 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.
section_title: APHIS’s Priorities Remain the Same, but Budget Changes Curtailed the Planned Expansion of Diagnostic Services
paragraphs: 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.
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. 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. 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. 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.
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. 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.
section_title: DHS Continues to Address Infrastructure Needs and Develop Programs Addressing Its Bioterrorism Priorities at Plum Island
paragraphs: 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.
section_title: DHS and USDA Are in the Process of Assessing Long-Term Plans for Joint Work at Plum Island
paragraphs: 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. 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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendation for Executive Action
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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 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.
section_title: Scope and Methodology
paragraphs: 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. 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.
section_title: List of Experts Interviewed
paragraphs: 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.
Corrie Brown, Ph.D., D.V.M. Professor and Coordinator of International  Activities, Department of Veterinary Medicine, University of Georgia,  Athens, Georgia.
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.
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.
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.
section_title: Animal Diseases That Affect Livestock
paragraphs: 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.
section_title: Comments from the Department of Homeland Security
paragraphs: The following are GAO’s comments on the Department of Homeland  Security’s letter dated November 22, 2005.
subsections: section_title: GAO Comments
paragraphs: 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. 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.
section_title: Comments from the U.S. Department of Agriculture
paragraphs: The following are GAO’s comments on the U.S. Department of Agriculture’s  letter dated November 30, 2005.
subsections: section_title: GAO Comments
paragraphs: 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.
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.