High-Containment Biosafety Laboratories: DHS Lacks Evidence to Conclude That Foot-and-Mouth Disease Research Can Be Done Safely on the U.S. Mainland
Published: 2008-05-22T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: DHS is proposing to move foot-and mouth disease (FMD) research from its current location at the Plum Island Animal Disease Center--located on a federally owned island off the northern tip of Long Island, New York--and potentially onto the United States mainland. FMD is the most highly infectious animal disease that is known. Nearly 100 percent of exposed animals become infected. A single outbreak of FMD on the U.S. mainland could have significant economic consequences. Concerns have been raised about moving FMD research off its island location and onto the U.S. mainland--where it would be in closer proximity to susceptible animal populations--as opposed to building a new facility on the island. GAO was asked to evaluate the evidence DHS used to support its decision that FMD work can be done safely on the U.S. mainland, whether an island location provides any additional protection over and above that provided by modern high containment laboratories on the mainland, and the economic consequences of an FMD outbreak on the U.S. mainland. In preparing this testimony, GAO interviewed officials from DHS and USDA, talked with experts in FMD and high-containment laboratories worldwide, and reviewed studies on FMD, high-containment laboratories, and the economic consequences of FMD outbreaks. GAO also visited the Plum Island Animal Disease Center and other animal biocontainment laboratories in other countries.
section_title: What GAO Found
paragraphs: GAO found that the Department of Homeland Security (DHS)has neither conducted nor commissioned any study to determine whether work on foot-and-mouth disease (FMD) can be done safely on the U.S. mainland. Instead, in deciding that work with FMD can be done safely on the mainland, DHS relied on a 2002 U.S. Department of Agriculture (USDA) study that addressed a different question. The study did not assess the past history of releases of FMD virus or other dangerous pathogens in the United States or elsewhere. It did not address in detail the issues of containment related to large animal work in BSL-3 Ag facilities. It was inaccurate in comparing other countries' FMD work experience with that of the United States. Therefore, GAO believes DHS does not have evidence to conclude that FMD work can be done safely on the U.S. mainland. While location, in general, confers no advantage in preventing a release, location can help prevent the spread of pathogens and, thus, a resulting disease outbreak if there is a release. Given that there is always some risk of a release from any biocontainment facility, most experts GAO spoke with said that an island location can provide additional protection. An island location can help prevent the spread of FMD virus along terrestrial routes, such as from vehicles splashed with contaminated mud, and may also reduce airborne transmission. Some other countries besides the United States have historically seen the benefit of an island location, with its remoteness from susceptible species and permanent water barriers. A recent release from the Pirbright facility--located in a farming community on the mainland of the United Kingdom--highlights the risks of a release from a laboratory that is in close proximity to the susceptible animals and provides the best evidence in favor of an island location. FMD has no health implications for humans, but it can have significant economic consequences, as recent outbreaks in the United Kingdom have demonstrated. The economic effects of an FMD outbreak in the United States, however, would depend on the characteristics of the outbreak and how producers, consumers, and the government responded to it. Although estimates vary, experts agree that the economic consequences of an FMD outbreak on the U.S. mainland could be significant, especially for red meat producers whose animals would be at risk for diseases, depending on how and where such an outbreak occurred.

section_title: Letter
paragraphs: We are pleased to be here to discuss our findings on the evidence the  Department of Homeland Security (DHS) has used to support its decision  that foot-and-mouth disease (FMD) work can be conducted as safely on  the U.S. mainland as on Plum Island.
By law, live FMD virus may be used only at a coastal island, such as Plum  Island, unless the Secretary of Agriculture specifically determines that it is  necessary and in the public interest to conduct such research and study on  the U.S. mainland. The only facility that studies high-consequence foreign  livestock diseases, such as FMD, in the United States is the Plum Island  Animal Disease Center (PIADC), located on a federally owned island off  the northern tip of Long Island, New York.
The U.S. Department of Agriculture (USDA) was responsible for Plum  Island from the 1950s until June 1, 2003. The Homeland Security Act of  2002 transferred Plum Island to DHS, shifting overall responsibility for  Plum Island to DHS, including all costs associated with PIADC’s  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.
DHS has identified PIADC as “reaching the end of its life cycle” and as  lacking critical capabilities to continue as the primary facility for such  work. DHS has announced that to meet the obligation of Homeland  Security Presidential Directive/HSPD-9, it will establish a new facility, the  National Bio and Agro-Defense Facility (NBAF). This facility, according to  DHS, would have high-containment laboratories able to safely contain the  pathogens currently under investigation at PIADC—including the FMD  virus.
FMD is the most highly infectious animal disease that is known. Nearly 100  percent of exposed animals become infected. The virus can spread from  infected animals in various ways, including by contaminated animal feed  or water, contaminated shoes or clothing, and contaminated vehicles or  farm equipment. In some circumstances, the wind can spread the virus  from farm to farm. The traditional approach, once infection is confirmed,  is to depopulate infected and potentially infected herds.
The United States has been free of FMD since 1929. A single outbreak of  FMD on the U.S. mainland could have significant consequences. The value  of U.S. livestock sales was $140 billion in 2007; about 10 percent of this  figure, or approximately $13 billion, is accounted for by export markets.  Concerns have been raised about moving FMD research off its island  location and onto the U.S. mainland, where it would be in closer proximity  to susceptible animal populations, as opposed to building a new facility on  the island.
You asked us to evaluate  1.  the evidence DHS used to support its decision that FMD work can be  done safely on the U.S. mainland,  2.  whether an island location provides any additional protection over and  above that provided by modern high containment laboratories on the  mainland, and  3.  the economic consequences of an FMD outbreak on the mainland.
To address the first question, we interviewed officials from DHS and  USDA. We visited PIADC and talked with DHS and USDA officials who  oversee and operate the facility, toured the animal containment areas, and  examined the unique aspects of the island location. We obtained and  reviewed relevant legislation and regulations governing USDA and DHS;  literature on FMD as well as on high-containment laboratories; and  agencies’ documents, including the study DHS used to support its  decision. In addition, we talked to the contractor who conducted the study  for USDA in 2002 and many of the members of the expert panel used in the  study. We also talked to experts on animal diseases and high-containment  laboratories dealing with animal, zoonotic, and human pathogens, as well  as representatives from the American Society for Microbiology, National  Grange of the Order of Patrons of Husbandry, National Cattlemen’s Beef  Association, and National Pork Producers Council.
For the second question, we interviewed officials from DHS and USDA  and experts in animal diseases. We visited and talked with officials of  some of the other facilities that are conducting FMD work, including the  Australian Animal Health Laboratory in Geelong, Canada’s National Centre  for Foreign Animal Disease in Winnipeg, the Danish National Veterinary  Institute on Lindholm Island, the German Federal Research Institute for  Animal Health (Friedrich-Loeffler-Institut) on the Island of Riems, and the  United Kingdom’s (UK) Institute for Animal Health Pirbright facility. In  addition, we talked to officials of the World Organisation for Animal  Health (OIE) in France.
For the third question, we obtained and reviewed studies conducted on  the economic consequences of the FMD outbreak in the United Kingdom  in 2002 and the potential consequences of outbreaks in the United States.
We conducted our work from March 2008 through May 2008 in accordance  with generally accepted government auditing standards.
subsections: section_title: Background
subsections: section_title: FMD Is a Highly Contagious Animal Disease
paragraphs: FMD is a highly contagious animal disease.  It affects cloven-hoofed  animals such as cattle, sheep, goats, and pigs, and has occurred in most  countries of the world at some point during the past century.  It has 7  types and over 80 subtypes. Immunity to, or vaccination for, one type of  the virus does not protect animals against infection from the other types.  FMD-infected animals usually develop blister-like lesions in the mouth, on  the tongue and lips, on the teats, or between the hooves. They salivate  excessively or become lame. Other symptoms include fever, reduced feed  consumption, and miscarriages. Cattle and pigs, which are very sensitive  to the virus, show disease symptoms after a short incubation period of 3 to  5 days. The incubation period in sheep is considerably longer, about 10 to  14 days, and the clinical signs of the disease are usually mild and may be  masked by other diseases, thereby allowing FMD to go unnoticed.
The mortality rate for young animals infected with FMD varies and  depends on the species and strain of the virus; in contrast, adult animals  usually recover once the disease has run its course. However, because the  disease leaves them severely debilitated, meat-producing animals do not  normally regain their lost weight for many months, and dairy cows seldom  produce milk at their former rate. Therefore, the disease can cause severe  losses in the production of meat and milk.
The FMD virus is easily transmitted and spreads rapidly. Before and during  the appearance of clinical signs, infected animals release the virus into the  environment through respiration, milk, semen, blood, saliva, and feces.  The virus may become airborne and spread quickly if pigs become infected  because pigs prolifically produce and excrete large amounts of the virus  into the air. Animals, people, or materials that are exposed to the virus can  also spread FMD by bringing it into contact with susceptible animals. For  example, the virus can spread when susceptible animals come in contact  with contaminated    animals;    animal products, such as meat, milk, hides, skins, and manure;   transport vehicles and equipment;    clothes or shoes worn by people; and    hay, feedstuffs, or veterinary biologics.
FMD virus is the most infectious animal disease-causing virus. It has been  determined that for certain strains, the dose required to infect cattle or  sheep through inhalation is about 10 organisms (10 1 TCID50). Infected  pigs produce immense amounts of airborne virus. An infected pig exhales  400 million organisms per day (10 8.6 TCID50). The sensitivity of cattle to  infection and the high levels of airborne virus produced by infected pigs  illustrate that the airborne spread of infection is another important factor  in FMD outbreaks.
FMD occurs throughout much of the world, and although some countries  have been free of FMD for some time, its wide host range and rapid spread  represent cause for international concern. After World War II, the disease  was widely distributed across the globe. In 1996, endemic areas included  Asia, Africa, and parts of South America. In North America, the last  outbreaks of FMD for the United States, Canada, and Mexico occurred in  1929, 1952, and 1953, respectively.
North America, Australia, and Japan have been free of FMD for many  years. New Zealand has never had a case of FMD. Most European  countries have been recognized as disease free, and countries belonging to  the European Union have stopped FMD vaccination.
section_title: Plum Island Animal Disease Center
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. Plum  Island’s research and diagnostic activities stem from its mission  to protect U.S. animal industries and exports from accidental or deliberate  introduction of foreign animal diseases. 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, pigs, 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.
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 them. 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 animals. USDA uses this biocontainment area for basic research,  for diagnostic work, and for the clinical training of veterinarians in the  recognition of foreign animal diseases. DHS now shares bench space with  USDA in the biocontainment area for its applied research. The North  American Foot-and-Mouth Disease Vaccine Bank is also located on Plum  Island.
USDA was responsible for Plum Island until June 1, 2003, when provisions  of the Homeland Security Act of 2002 were implemented that transferred  Plum Island, including all its assets and liabilities, to DHS. This action  shifted overall responsibility for Plum Island to DHS, including all the  costs associated with the facility’s 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.
Plum Island is now operated as 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 DHS’s  Science and Technology Directorate, the strategy for protecting livestock  also includes work at DHS’s National Center for Food Protection and  Defense and at its National Center for Foreign Animal and Zoonotic  Disease Defense, as well as at 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.
section_title: National Bio and Agro- Defense Facility
paragraphs: Homeland Security Presidential Directive 9 tasks the Secretary of  Agriculture and the Secretary of Homeland Security to develop a plan to  provide safe, secure, and state-of-the-art agriculture biocontainment  laboratories for the research and development of diagnostic capabilities  for foreign animal and zoonotic diseases. To partially meet these  obligations, DHS has asked the Congress to appropriate funds to construct  NBAF, a new facility. This facility would house high-containment  laboratories able to handle the pathogens currently under investigation at  PIADC, as well as other pathogens of interest.
DHS selected five potential sites for NBAF in July 2007 and must prepare  an environmental impact statement (EIS) for each site. According to  DHS, although not included in the competitive selection process, the DHS- owned PIADC will now be considered as a potential NBAF site, and DHS  will also prepare an EIS for Plum Island. (See table 1.)
DHS has asked for public comment on the selection process. Following  completion of the environmental impact statements and public hearings,  DHS expects to choose a site by October 2008 and to open NBAF in 2014.  According to DHS officials, the final construction cost will depend on the  site’s location and may exceed the currently projected $451 million.  Additional expenses, such as equipping the new facility and relocating  existing personnel and programs, may reach $100 million. DHS has not yet  determined what action to take with respect to PIADC when construction  of NBAF has been completed.
section_title: Evidence That FMD Work Can Be Conducted Safely on the U.S. Mainland Is Lacking
paragraphs: We found that DHS has neither conducted nor commissioned any study to  determine whether FMD work can be done safely on the U.S. mainland.  Instead, DHS relied on a study that USDA commissioned and a contractor  conducted in May 2002 that examined a different question: whether it is  technically feasible to conduct exotic disease research and diagnostics,  including FMD and rinderpest, on the U.S. mainland with adequate  biosafety and biosecurity to protect U.S. agriculture.  This approach fails  to recognize the distinction between what is technically feasible and what  is possible, given the potential for human error. DHS told us that this study  has allowed it to conclude that it is safe to conduct FMD work on the U.S.  mainland.
In addition to a number of other methodological problems with the study,  we found that it was selective in what it considered in order to reach its  findings. In particular, the study  1.  did not assess the history of releases of FMD virus or other dangerous  2.  did not address in detail the issues related to large animal work in BSL- 3 Ag facilities, and  3.  was inaccurate in comparing other countries’ FMD work experience  with that of the United States.
A comprehensive analysis to determine if FMD work could be conducted  safely on the U.S. mainland would have considered these points, at a  minimum. DHS did not identify or remedy these deficiencies before using  the USDA study to support its conclusions. Consequently, we believe DHS  does not have evidence to conclude that FMD work can be done safely on  the U.S. mainland.
subsections: section_title: The Study Did Not Examine the Evidence from Past Releases of FMD or Other Dangerous Pathogens
paragraphs: We found no evidence that the study examined data from past releases of  FMD—particularly the release of FMD on Plum Island in 1978—or the  history of internal releases at PIADC. The study did not assess the general  history of accidents within biocontainment laboratories, and it did not  consider the lessons that can be learned from a survey of the causes of  such accidents. Such a survey would show that technology and operating  procedures alone cannot ensure against a release, since human error can  never be completely eliminated and since a lack of commitment to the  proper maintenance of biocontainment facilities and their associated  technology—as the Pirbright facility showed—can cause releases.
The study panel members we interviewed said that no data on past  accidents with or releases of either FMD or other pathogens was  systematically presented or discussed. Rather, the panel members recalled  that they relied on their own knowledge of and experience with the history  of releases in a general discussion.
The release of FMD virus from facilities is very rare. In fact, the incidence  of the release of any dangerous pathogen from modern containment  facilities is quite low. During the vast majority of the time, such facilities  have been operating safely. Some releases have occurred, however. Table  2 lists known and attributed releases of FMD virus from laboratories  worldwide, including those that produce vaccines.
A particular deficiency in the 2002 USDA study was the omission of any  explicit analysis of the release of FMD virus from Plum Island itself in  1978. In September of that year, FMD virus was found to have infected  clean animals being held outside the laboratory compound in the  quarantined animal supply area of PIADC. The exact route by which the  virus escaped from containment and subsequently infected the animal  supply was never definitely ascertained. An internal investigation  concluded that the most probable routes of escape of the virus from  containment were (1) faulty air balance of the incinerator area, (2) leakage  through inadequately maintained air filter and vent systems, and (3)  seepage of water under or through a construction barrier near the  incinerator area. Animal care workers then most likely carried the disease  back to the animal supply area on the island, where it infected clean  animals being held for future work. (See table 3.)
An analysis of the deficiencies underlying these probable routes of escape  noted during the investigation show that all were related to human error  and that none were related to insufficient containment technology. Any  one of these deficiencies could happen in a modern facility, since they  were not a function of the technology or its sophistication, procedures or  their completeness, or even, primarily, the age of the facility. The  deficiencies were errors in human judgment or execution and, as such,  could occur today as easily as they did in 1978.
In addition, a number of incidents at PIADC have resulted in internal  releases such that animals within the laboratory compound inadvertently  became infected, although no FMD virus was released outside the facility.  These incidents show that technology sometimes fails, facilities age, and  humans make mistakes. Table 4 lists known internal releases of FMD virus  at PIADC since 1971.
These incidents involved human error, lack of proper maintenance,  equipment failure, and deviation from standard operating procedures.  Many were not a function of the age of the facility or the lack of  technology and could happen in any facility today. While these incidents  did not directly result in any external release, they could have been useful  in the 2002 study in illustrating the variety of ways in which internal  controls—especially in large animal biocontainment facilities—can be  compromised.
Given the rarity of the release of FMD virus from laboratories, and how  relevant its release is to the question of moving FMD work off its present  island location, we believe that the 2002 study was remiss in not more  explicitly considering this matter. In fact, members of the panel we spoke  with could recall little, if any, discussion of incidents of release at Plum  Island.
Beyond the history of incidents at Plum Island, we found no evidence that  the study considered the history of accidents in or releases from  biocontainment facilities generally. Had the study considered this history,  it would have shown that no facility for handling dangerous pathogens can  ever be completely safe and that no technology can be totally relied on to  ensure safety.
The study found that “today’s technology is adequate to contain any  biosafety risks at any site.” While we agree that technology— biocontainment facilities, filtration technologies, and the like—has come a  long way and is a critical component of biosafety, we believe that it is  inadequate by itself in containing biosafety risks. A comprehensive  biosafety program involves a combination of biocontainment technology,  proper procedures, and properly trained people. The study also concurred  that “biosafety is only as effective as the individual who practices it.”
Even with a proper biosafety program, human error can never be  completely eliminated. Many experts told us that the human component  accounts for the majority of accidents in high-containment laboratories.  This risk persists, even in the most modern facilities and with the latest  technology. The 2002 study, in fact, acknowledged this, although it did not  elaborate on the critical role that people play in keeping biocontainment  laboratories safe when it stated that “biosafety is only as effective as the  individual who practices it.” The study’s summary conclusion that  “biocontainment technology allows safe research” is, therefore,  disingenuous.
Finally, as we have reported previously, the maintenance of any  biocontainment facility or technology plays a critical role in biosafety.   For example, the lack of proper maintenance was one of the probable  routes of escape in the 1978 release at Plum Island. High-containment  laboratories are highly sophisticated facilities that require specialized  expertise to design, construct, operate, and maintain. Because they are  intended to contain dangerous microorganisms, usually in liquid or aerosol  form, even minor structural defects—such as cracks in the wall, leaky  pipes, or improper sealing around doors—can often have severe  consequences. For example, leaking drainage pipes was determined to be  the likely cause of the FMD outbreak at Pirbright in 2007.
According to the experts we talked with, failure to budget for and conduct  regular inspections and maintenance of biocontainment facilities is a risk  to which even the most modern facilities are susceptible. All the experts  we talked with, including the panel members who contributed to the 2002  study, emphasized the importance of effective maintenance and the need  to protect maintenance budgets from being used for other purposes. One  official told us, for example, that as his containment facility ages, he is  spending more and more of his operating budget on maintenance and that,  in fact, he is having to offset the rise in maintenance costs from other  categories of funding within his overall budget.
section_title: The Study Did Not Address in Detail the Issues of Containment Related to Large Animals Infected with FMD
paragraphs: The 2002 study did not address in detail the issues of containment related  to large animals like cattle and pigs, which present problems very different  from those of laboratory animals like rats, mice, and guinea pigs. It did not  address the unique risks associated with the special containment spaces  required for large animals or the impact of highly concentrated virus loads  on such things as the air filtration systems.
Large animals cannot be kept in containers. They must be allowed  sufficient space to move around in. Handling large animals within confined  spaces—a full size cow can weigh up to 1,430 pounds—can present special  dangers for the scientists as well as the animal handlers. Moving carcasses  from contained areas to necropsy or incineration poses additional risks.  For example, one of the internal releases of FMD virus at PIADC happened  in transporting large animal carcasses from contained rooms through to  incineration.
Although it could not have been known to the study group in 2002,  transferring FMD work to NBAF is to be accompanied by an increase in  both scope and complexity over the current activities at PIADC. These  increases in scope and complexity would mean an increase in the risk  associated with work at the new facility. For example, the proposed BSL-3  Ag space at the new NBAF is projected to be almost twice the size of the  space currently at PIADC and is to accommodate many more large  animals. USDA’s Agricultural Research Service animal holding area  requirements at PIADC specify space for 90 cattle, 154 swine, or 176 sheep  (or combinations thereof). Translational studies will involve clinical trials  with aerosolized FMD virus challenging groups of 30 to 45 animals and  lasting 3 to 6 months. This is contrasted with about 16 large animals that  PIADC can process today.
Moreover, unique risks are associated with BSL-3 Ag facilities, where the  facility itself is considered the primary containment area. In a standard  BSL-3 laboratory, in contrast, work is done within a biological safety  cabinet, which provides the primary level of containment, eliminating  direct contact between the human operator and infected material. The  outer parts of the facility walls thus provide a secondary barrier. Because  large animals cannot be handled within a biological safety cabinet, they  are free to move around in a BSL-3 Ag laboratory, where the laboratory  walls provide the primary containment.
An important difference between a standard BSL-3 laboratory, such as  those used with human pathogens, and a BSL-3 Ag laboratory therefore is  that in the latter there is extensive direct contact between the human  operator and the infected animal and, consequently, the virus. Because the  virus can be carried in a person’s lungs, nostrils, or other body parts, the  human becomes a potential avenue by which the virus can escape the  facility. Special biosafety procedures are needed—for example, a full  shower upon exiting containment, accompanied by expectorating to clear  the throat and blowing through the nose to clear the nasal passages.  Additionally, a 5-to-7-day quarantine period is usually imposed on any  person who has been within containment where FMD virus is present, a  tacit acknowledgment that humans can carry the disease out with them  even after these additional procedures. Although the study mentioned  these matters, it gave no indication that these unique risks associated with  working in large animal biocontainment facilities informed the study’s  eventual findings.
We also found that the study did not consider other safety issues specific  to FMD. For example, the study did not look at the likely loads that air  filtration systems have to deal with, especially in the case of pigs infected  with FMD virus—which, through normal expiration, excrete very large  amounts of virus-laden aerosols. Properly fitted and maintained high- efficiency particulate air (HEPA) filters are a key factor in all modern  biocontainment facilities and have a record of being highly effective in  keeping aerosolized pathogens, including viruses, contained. Nevertheless,  they do not represent an absolute barrier. The typical standard for such  filters is that they must operate with an efficiency of at least 99.97  percent. Often the highest level-containment laboratories use two HEPA  filters in series, in addition to prefiltration systems, to gain increased  efficiency. However, we found no indication that the study examined  specific filtration issues with the FMD virus or that it questioned the  efficiency of such systems specifically in relation to a high-volume  challenge of virus, a concern that, while remote, should not have been  dismissed, given the very low dose of FMD virus required for animals to  become infected.
section_title: The Study Was Inaccurate in Comparing Other Countries’ FMD Work Experience with the Situation in the United States
paragraphs: The study cited the experience of three countries around the world in  working with FMD—Australia, Canada, and the United Kingdom. While  the study cited Australia as a foreign precedent, it noted that Australia has  not conducted any FMD work on the mainland. In fact, Australia—by  law—does not allow any FMD work on the mainland. In this respect, it is  even more restrictive than the United States. Australia maintains a ban on  live virus FMD work at all its laboratories, whether on mainland, island, or  peninsula, including the laboratory at Geelong—considered by many to be  the premier laboratory in the world in terms of state-of-the-art animal  containment technology. Australia mitigates the risk FMD poses to its  livestock by outsourcing its FMD work to other countries.
The Canadian laboratory at Winnipeg was not in operation at the time of  the 2002 study and is not appropriately compared to the U.S. situation.  Canada has decided to conduct FMD work on the mainland. However, it is  in a downtown location where there is little likelihood that susceptible  animals will be in the immediate neighborhood. In addition, its scope of  work for FMD is smaller than the present FMD work at the PIADC facility  or the proposed facility. The proposed U.S. sites are potentially more  likely to pose a risk, given their closer proximity to susceptible animal  populations.
The 2002 study used the U.K. Pirbright facility as an example of a  precedent for allowing FMD work on the mainland. The study participants  could not have known in 2002, however, that an accidental release of FMD  virus at the Pirbright facility in 2007 led directly to eight separate  outbreaks of FMD on farms surrounding the Pirbright laboratory. This fact  highlights the risks of release from a laboratory that is in close proximity  to susceptible animals and provides the best evidence in favor of an island  location.
Finally, the study did not consider the German and Danish situations. For  example, all FMD work with large animals in Germany is restricted to  Riems, an island just off the northeastern coast of Germany in the Baltic  Sea. FMD work in Germany was originally restricted to the island in  the1910s. During the post-World War II period, when Riems was controlled  by East Germany, West Germany maintained a separate mainland facility  for its FMD research, but after re-unification, Germany again decided to  restrict all FMD research to Riems and disestablished the mainland  facility. Construction is currently under way to expand the facility on the  island at Riems.
Similarly, Denmark restricts all FMD work to the National Veterinary  Institute Department of Virology, on the island of Lindholm. The Danish  government has recently made a further commitment to Lindholm and has  rebuilt a new BSL-3 Ag laboratory exclusively for FMD work on the island.
section_title: Given That Releases Can Occur from Any Biocontainment Facility, an Island Location Can Provide Additional Protection
paragraphs: While location confers no advantage in preventing a release, location can  help prevent the spread of FMD virus and a resulting disease outbreak, if  there is a release. An island location can help prevent the spread of FMD  virus along terrestrial routes, such as by vehicles splashed with  contaminated mud or other material. An examination of the empirical  evidence of past FMD releases from research facilities shows that an  island location can help keep a release from becoming a more general  outbreak. Another benefit of an island location is that it provides a  permanent geographical barrier that may not be impregnable but that can  more easily allow the Office International des Epizooties (OIE) to declare  the rest of the U.S. mainland disease-free from FMD if there happened to  be a release on the island.
Experts we spoke with—including a number of the expert panel members  from the 2002 study—agreed that an island location provides additional  protection. They agreed that all other factors being equal, FMD research  can be conducted more safely on an island than in a mainland location.
A comparison of the releases at Plum Island in 1978 and Pirbright in 2007  provides evidence that an island location can help keep a release from  becoming a more general outbreak. In September 1978, FMD virus was  found to have been released from containment at PIADC. The exact route  of escape was never definitely ascertained, but clean animals held on the  island in the animal supply area outside the laboratory compound became  infected with FMD.
However, no virus was ever found off the island. In fact, when the  subsequent investigation by USDA’s Animal and Plant Health Inspection  Service on the mainland of Long Island found that no spread of FMD,  OIE—in consideration of PIADC’s island location—continued to officially  consider the United States as a whole free from FMD. This was a  significant declaration that allowed the continued unrestricted export of  U.S. animal products from the mainland.
In summarizing the 1978 FMD virus release, the PIADC Safety  Investigation Committee identified three main PIADC lines of defense that  stood as barriers against the escape of disease agents: (1) the design,  construction, and operation of its laboratory buildings; (2) its restrictions  on the movement of personnel, materials, supplies, and equipment; and (3)  the island location. This internal investigation concluded that although  the first two barriers had been breached, probably by human error, the  final line of defense—the island location—succeeded in containing the  release from becoming a wider outbreak beyond PIADC itself.
The 1978 release at Plum Island can be compared to the release at  Pirbright in the summer of 2007. Pirbright is located on the mainland of  Great Britain in Surrey, a semi-agricultural area just southwest of London.  The U.K. Institute for Animal Health and Merial, a commercial vaccine  production plant, are collocated there, and both work with FMD virus. The  site is surrounded by a number of “hobby farms,” on some of which 40 to  50 cattle are bred and raised. In summer 2007, cattle on farms near the  Pirbright facility became infected with FMD. Subsequent investigations  concluded that the likely source of the release was a leaking drainage pipe  at the facility that carried waste from the contained areas to an effluent  treatment plant. The virus was then spread onto local farms by the  splashing of contaminated mud onto vehicles that had unrestricted access  to the contaminated area and could easily drive onto and off the site. The  investigations determined that there had been a failure to properly  maintain the site’s infrastructure. In all, eight separate outbreaks occurred  over a 2-month period.
A key difference, of course, between the Pirbright incident in 2007 and the  incident at Plum Island in 1978 is that virus did not spread off the Plum  Island.
Similarly, escapes in 1968 in Denmark from the Lindholm facility and in  the 1970s in Germany from the Riems facility, when compared to Pirbright  in 2007, also demonstrate the benefit of an island location in containing a  release.
subsections: section_title: An Island Facility Could More Easily Allow the United States to Maintain Disease-Free Status If a Release Were to Occur
paragraphs: Since 1996, OIE has provided a procedure for officially recognizing the  sanitary status of countries with regard to particular animal diseases,  including FMD. A country can apply for and be granted disease-free status  if it can prove that a disease is not present in the country. Ad hoc groups  of international experts examine countries’ applications for official  recognition of sanitary status. An elected Specialist Commission reviews  the recommendations of these groups and either accepts or rejects them.
If an outbreak does occur, procedures exist for countries to regain their  disease-free status. This offers significant economic benefit, because  export bans can exist for countries not considered disease-free. In 2002,  GAO reported that an export ban on U.S. livestock products because of an  FMD outbreak in the United States, similar to the 2001 outbreak in the  United Kingdom, could result in losses of $6 billion to $10 billion a year  while the nation eradicated the disease and regained disease-free status.
Instead of revoking the U.S. disease-free status in response to the 1978  release at Plum Island, OIE continued to consider the United States as a  whole free from FMD. This was because of the facility’s island location.  This status from OIE allowed the United States to continue exporting  animal products from the mainland after the release was identified.  However, these OIE officials said that if a similar release were to occur  from a facility on the U.S. mainland, OIE would most likely not be able to  declare the United States disease-free. In their view, the island location  provides a natural “zoning” ability that, under OIE’s rules, more easily  allows the country to prove the compartmentalization that is necessary for  retaining “disease-free” status.
section_title: The Economic Consequences of an FMD Outbreak in the United States Could Be Significant
paragraphs: While humans cannot become infected with FMD through contact with  infected animals or through eating products of diseased animals, still, FMD  can have economic consequences, as recent outbreaks in the United  Kingdom have demonstrated. Although estimates vary, experts agree that  the economic consequences of an FMD outbreak on the U.S. mainland  could be significant, especially for red meat producers whose animals  would be at risk for diseases, depending on how and where such an  outbreak occurred.
subsections: section_title: The Economic Impact of the 2001 FMD Outbreak in the United Kingdom
paragraphs: According to a study by the U.K. National Audit Office, the direct cost of  the 2001 FMD outbreak to the public sector was estimated at over $5.71  billion and the cost to the private sector was estimated at over $9.51  billion. By the time the disease was eradicated, in September 2001, more  than six million animals had been slaughtered: over four million for  disease control purposes and two million for welfare reasons.
Compensation and other payments to farmers were expected to total  nearly $2.66 billion. Direct costs of measures to deal with the epidemic,  including the purchase of goods and services to eradicate the disease,  were expected to amount to nearly $2.47 billion. Other public sector costs  were estimated at $0.57 billion.
In the private sector, agriculture and the food chain and supporting  services incurred net costs of $1.14 billion. Tourism and supporting  industries lost revenues eight times that level—$8.56 billion to $10.27  billion, when the movement of people in the countryside was restricted.  The Treasury had estimated that the net economic effect of the outbreak  was less than 0.2 percent of gross domestic product, equivalent to less  than $3.8 billion.
section_title: The Potential Impact of an FMD Outbreak in the United States
paragraphs: The possibility of the introduction of FMD into the United States is of  concern because this country has the largest fed-cattle industry in the  world, and it is the world largest producer of beef, primarily high-quality,  grain-fed beef for export and domestic use.
Although estimates of the losses vary, experts agree that the economic  consequences of an FMD outbreak on the U.S. mainland could mean  significant losses, especially for red meat producers, whose animals would  be at risk for disease, depending on how and where an outbreak occurred.  Current estimates of U.S. livestock inventories are 97 million cattle and  calves, 7 million sheep, and 59 million hogs and pigs, all susceptible to an  FMD outbreak. The total value of the cash receipts for U.S. livestock in  2007 was $141.4 billion. The total export value of red meat in 2007 was $6.4  billion. These values represent the upper bound of estimated losses.
Direct costs to the government would include the costs of disease control  and eradication, such as the maintenance of animal movement controls,  control areas, and intensified border inspections; the destruction and  disposal of infected animals; vaccines; and compensation to producers for  the costs of disease containment. However, government compensation  programs might not cover 100 percent of producers’ costs. As a result,  direct costs would also occur for disinfection and for the value of any  slaughtered animals not subject to government compensation.
According to the available studies, the direct costs of controlling and  eradicating a U.S. outbreak of FMD could vary significantly, depending on  many factors including the extent of the outbreak and the control strategy  employed.
Indirect costs of an FMD outbreak would include costs affecting  consumers, ancillary agricultural industries, and other sectors of the  economy. For example, if large numbers of animals were destroyed as part  of a control and eradication effort, then ancillary industries such as meat  processing facilities and feed suppliers would be likely to lose revenue.
Furthermore, an FMD outbreak could have adverse effects such as  unemployment, loss of income (to the extent that government  compensation would not fully reimburse producers), and decreased  economic activity, which could ripple through other sectors of the  economy as well. However, our analyses show that these effects would  likely be local or regional and limited in scope.
The economic effects of an FMD outbreak would depend on the  characteristics of the outbreak and how producers, consumers, and the  government responded to it. The scale of the outbreak would depend on  the time elapsed before detection and the number of animals exposed,  among other factors. Costs to producers of addressing the disease  outbreak and taking steps to recover would similarly vary. The responses  of consumers in the domestic market would depend on their perceptions  of safety, as well as changes in the relative prices of substitutes for the  affected meat products, as supply adjusted to the FMD disruption. In  overseas markets, consumers, responses would be mediated by the  actions their governments would take or not take to restrict imports from  the United States. Because an overall estimate of effects depends heavily  on the assumptions made about these variables, it is not possible to settle  on a single economic assessment of the cost to the United States of an  FMD outbreak. We have reviewed literature that considers but a few of the  many possible scenarios in order to illustrate cost components and to  consider the possible market reaction rather than to predict any particular  outcome.
section_title: Conclusions
paragraphs: DHS believes that modern technology, combined with biosafety practices,  can provide for a facility’s safe operation on the U.S. mainland. Most  experts we talked with believe that technology has made laboratory  operations safer over the years. However, accidents, while rare, still occur  because of human or technical errors. Given the non-zero risk of a release  from any biocontainment facility, most of the experts we spoke with told  us that an island location can provide additional protection.
DHS has not conducted any studies to determine whether FMD work can  be done safely on the mainland. Instead, in proposing to move FMD virus  to the mainland, DHS relied on a 2002 USDA study that addressed a  different question. That study does not clearly support the conclusion that  FMD work can be done safely on the mainland.
An island location can help prevent the spread of FMD virus along  terrestrial routes, such as by vehicles splashed with contaminated mud,  and may also reduce airborne transmission. Historically, the United States  and other countries as well have seen the benefit of an island location,  with its combination of remoteness from susceptible species and a  permanent water barrier.
Although FMD has no human-health implications, recent outbreaks in the  United Kingdom have demonstrated its economic consequences.
Estimates for the United States vary but would depend on the  characteristics of the outbreak and how producers, consumers, and the  government responded to it.
section_title: Contacts and Acknowledgments
paragraphs: For further information regarding this statement, please contact Nancy  Kingsbury, Ph.D., at (202) 512-2700 or kingsburyn@gao.gov, or Sushil K.  Sharma, Ph.D., Dr.PH, at (202) 512-3460 or sharmas@gao.gov. Contact  points for our Offices of Congressional Relations and Public Affairs may  be found on the last page of this statement. William Carrigg, Jack Melling,  Penny Pickett, and Elaine Vaurio made key contributions to this  statement.
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