Biological Research: Observations on DHS's Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island
Published: 2009-07-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Foot-and-mouth disease (FMD) is the most highly infectious animal disease known: nearly 100 percent of exposed animals become infected with it. Although the United States has not had an outbreak of FMD since 1929, a single outbreak of FMD virus as a result of an accidental or intentional release from a laboratory on the U.S. mainland could have significant consequences for U.S. agriculture. The traditional approach to the disease, once infection is confirmed, is to depopulate infected and potentially infected livestock herds to eradicate the disease. The value of U.S. livestock sales was $140 billion in 2007; about 10 percent of this figure, or approximately $13 billion, was accounted for by export markets. The Plum Island Animal Disease Center (PIADC), on a federally owned island off the northern tip of Long Island, New York, is the only facility in the United States that studies the live FMD virus. The U.S. Department of Agriculture (USDA) was responsible for the PIADC from its opening in the 1950s until June 2003, when USDA transferred responsibility for it to the U.S. Department of Homeland Security (DHS), as required by the Homeland Security Act of 2002. 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 the PIADC. Also, under Homeland Security Presidential Directive 9 (HSPD-9), the secretary of Agriculture and the secretary of Homeland Security are to develop a plan to provide safe, secure, and state-of-the-art agricultural biocontainment laboratories for researching and developing diagnostic capabilities for foreign animal and zoonotic diseases. On January 19, 2006, DHS announced that to meet its obligations under HSPD-9, it would construct and operate a new facility--the National Bio- and Agro-Defense Facility (NBAF)--containing several biosafety level 3 (BSL-3) laboratories, BSL-3 agricultural (BSL-3-Ag) laboratories, and biosafety level 4 (BSL-4) laboratories. FMD research is to be performed in a BSL-3-Ag laboratory. When fully operational, the NBAF is meant to replace the PIADC. The primary research and diagnostic focus at the PIADC is foreign or exotic diseases, including FMD virus, that could affect livestock, including cattle, pigs, and sheep. DHS stated that the PIADC was "nearing the end of its life cycle" and was lacking critical capabilities to continue as the primary facility for such work. Another reason DHS cited was the need to be close to research facilities. According to DHS, although the PIADC coordinates with many academic institutes throughout the northeast, its isolated island location means that few academic institutes are within a reasonable commuting distance; DHS believes that these are needed to provide research support and collaboration required for the anticipated NBAF program. We are doing this work to respond to the statutory mandate in the fiscal year 2009 appropriations act for DHS (Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (Public Law 110-329)). The act restricted DHS's obligation of funds for constructing the NBAF on the mainland until DHS completed a risk assessment on whether FMD work can be done safely on the U.S. mainland and we reviewed DHS's risk assessment. In our review, we specifically assessed the evidence DHS used to conclude that work with FMD can be conducted as safely on the U.S. mainland as on Plum Island, New York.
section_title: What GAO Found
paragraphs: DHS developed a threat and risk analysis independent of the environmental impact statement (EIS) that identified and evaluated potential security risks--threats, vulnerabilities, and consequences--that might be encountered in operating the NBAF. They included crimes against people and property and threats from compromised or disgruntled employees. The objectives of this analysis were to present the risks and effective mitigation strategies for ensuring the NBAF's secure operation and to help DHS select the site with the fewest unique security threats. DHS concluded that the EIS and threat and risk analysis showed very little differentiation across the six sites and considered that the safety and security risks that had been identified at all sites were acceptable, with or without mitigation. Specifically, for all sites the risk was zero to low for all accident scenarios, except for an overpressure fire--an explosion from the buildup of a large amount of gas or flammable chemical in an enclosed area. The risk of an overpressure fire accident was moderate for all sites For all sites--except Plum Island--the overall risk rank was moderate, based on the potential for infection and opportunity for disease to spread through livestock or wildlife. The Plum Island site's overall risk rank was low, because the likelihood of any disease spreading beyond the island was small, since animals do not live in the vicinity and the potential for infection is less. The threat and risk assessment concluded that the insider threat would be the biggest threat to the NBAF and would be independent of the site.

section_title: Letter
paragraphs: Foot-and-mouth disease (FMD) is the most highly infectious animal  disease known: nearly 100 percent of exposed animals become infected  with it. Although the United States has not had an outbreak of FMD since  1929, a single outbreak of FMD virus as a result of an accidental or  intentional release from a laboratory on the U.S. mainland could have  significant consequences for U.S. agriculture. The traditional approach to  the disease, once infection is confirmed, is to depopulate infected and  potentially infected livestock herds to eradicate the disease. The value of  U.S. livestock sales was $140 billion in 2007; about 10 percent of this  figure, or approximately $13 billion, was accounted for by export markets.
The Plum Island Animal Disease Center (PIADC), on a federally owned  island off the northern tip of Long Island, New York, is the only facility in  the United States that studies the live FMD virus. The U.S. Department of  Agriculture (USDA) was responsible for the PIADC from its opening in the  1950s until June 2003, when USDA transferred responsibility for it to the  U.S. Department of Homeland Security (DHS), as required by the  Homeland Security Act of 2002. 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 the PIADC. Also, under  Homeland Security Presidential Directive 9 (HSPD-9), the secretary of  Agriculture and the secretary of Homeland Security are to develop a plan  to provide safe, secure, and state-of-the-art agricultural biocontainment  laboratories for researching and developing diagnostic capabilities for  foreign animal and zoonotic diseases.
On January 19, 2006, DHS announced that to meet its obligations under  HSPD-9, it would construct and operate a new facility—the National Bio-  and Agro-Defense Facility (NBAF)—containing several biosafety level 3  (BSL-3) laboratories, BSL-3 agricultural (BSL-3-Ag) laboratories, and  biosafety level 4 (BSL-4) laboratories. FMD research is to be performed in  a BSL-3-Ag laboratory. When fully operational, the NBAF is meant to  replace the PIADC. The primary research and diagnostic focus at the  PIADC is foreign or exotic diseases, including FMD virus, that could affect  livestock, including cattle, pigs, and sheep. DHS stated that the PIADC was  “nearing the end of its life cycle” and was lacking critical capabilities to  continue as the primary facility for such work. Another reason DHS cited  was the need to be close to research facilities. According to DHS, although  the PIADC coordinates with many academic institutes throughout the  northeast, its isolated island location means that few academic institutes  are within a reasonable commuting distance; DHS believes that these are  needed to provide research support and collaboration required for the  anticipated NBAF program.
We testified in May 2008 that (1) studies that DHS cited in support of its  conclusion that FMD work can be done as safely on the mainland did not  specifically examine a possible FMD virus release and (2) DHS had not  conducted or commissioned studies to show that FMD virus work can be  done safely on the mainland. In response, DHS stated that the results of  its forthcoming draft environmental impact statement (EIS) on the site  proposed for the NBAF would provide the evidence needed to assess  whether FMD research can be conducted safely on the U.S. mainland.
On June 27, 2008, DHS published the notice of availability for the NBAF  draft EIS in the Federal Register, soliciting public comments. On  December 12, 2008, DHS published a notice of availability for the NBAF  final EIS in the Federal Register, and on January 16, 2009, it published its  decision to construct the new NBAF at a site in Manhattan, Kansas, to  replace the PIADC, based on the information and analysis in the final EIS  and other factors.
We are doing this work to respond to the statutory mandate in the fiscal  year 2009 appropriations act for DHS (Consolidated Security, Disaster  Assistance, and Continuing Appropriations Act, 2009 (Public Law 110- 329)). The act restricted DHS’s obligation of funds for constructing the  NBAF on the mainland until DHS completed a risk assessment on whether  FMD work can be done safely on the U.S. mainland and we reviewed  DHS’s risk assessment. In our review, we specifically assessed the  evidence DHS used to conclude that work with FMD can be conducted as  safely on the U.S. mainland as on Plum Island, New York.
To accomplish this task, we reviewed agencies’ documents, including the  draft and final EIS, threat and risk assessment, and studies conducted by  DHS’s Biodefense Knowledge Center (BKC) at Lawrence Livermore  National Laboratory (LLNL). We also reviewed relevant legislation and  regulations governing USDA and DHS and literature on FMD and high- containment laboratories (HCL). We interviewed officials from the DHS  Office of Science and Technology and USDA Agriculture Research Service.  We visited the PIADC, where we examined animal containment areas and  unique aspects of the island location, and we talked with DHS and USDA  officials who oversee and operate the facility. We also talked with the  contractors who performed the dispersion modeling and with officials of  BKC who analyzed the potential impact of an accidental release of FMD  virus from each proposed facility. We also talked with experts on animal  diseases and HCLs dealing with animal, zoonotic, and human pathogens.
We consulted with large-animal veterinarians and agriculture economists.  We talked with officials of the Interagency Modeling and Atmospheric  Assessment Center at LLNL, the Defense Threat Reduction Agency, the  National Ground Intelligence Center of the U.S. Army, the Risø National  Laboratory for Sustainable Energy at the Technical University of  Denmark, and the Division of Meteorological Model Systems of the Danish  Meteorological Institute, as well as other experts on plume modeling.
We also visited other facilities that conduct FMD work, including  Denmark’s National Veterinary Institute on Lindholm Island, Germany’s  Federal Research Institute for Animal Health (Friedrich-Loeffler-Institut)  on the Island of Riems, and the United Kingdom’s Institute for Animal  Health Pirbright Laboratory. We also talked with officials at the Australian  Animal Health Laboratory in Geelong and Canada’s National Centre for  Foreign Animal Disease in Winnipeg. In addition, we talked with officials  of the World Organisation for Animal Health (OIE) in France.
We conducted our work from October 2008 through May 2009 in  accordance with generally accepted government auditing standards. Those  standards require that we plan and perform an audit to obtain sufficient,  appropriate evidence to provide a reasonable basis for our findings and  conclusions, based on our audit objectives. We believe that the evidence  we obtained provides a reasonable basis for our findings and conclusions,  based on our audit objectives.
subsections: section_title: Background
subsections: section_title: The Foot-and-Mouth Disease Virus
paragraphs: FMD is a highly infectious disease that affects cloven-hoofed animals,  including livestock such as cattle, sheep, goats, and pigs. FMD virus has  seven serotypes and many 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 abortion. Cattle and pigs, which are very  sensitive to the virus, show disease symptoms after a short incubation  period of 3 to 5 days. In sheep, the incubation period is considerably  longer, about 3 to 12 days, and the clinical signs of the disease are usually  mild and may be masked by other diseases, allowing FMD to go unnoticed.
The mortality rate for young animals infected with FMD depends on the  species and strain of the virus. Adult animals usually recover once the  disease has run its course, but because FMD 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. Thus, the disease can cause severe losses in the production of  meat and milk.
FMD virus is easily transmitted and spreads rapidly. Before and during the  appearance of clinical signs, infected animals release it into the  environment through respiration, milk, semen, blood, saliva, and feces.  The virus may become airborne and spread quickly when animals become  infected. The virus replicates prolifically in pigs, so that they release large  amounts of the virus into the air. Animals, people, or materials 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 animal products (meat, milk, hides, skins, manure);  transport vehicles and equipment; clothes or shoes; and hay, feed, or  veterinary biologics.
section_title: FMD Outbreaks
paragraphs: FMD outbreaks occurred in most countries of the world during the  twentieth century. Although some countries have been free of FMD for  some time, its wide host range and rapid spread constitute cause for  international concern. After World War II, the disease was widely  distributed around the world. In 1996, endemic areas included Africa, Asia,  and parts of South America. In North America, the last outbreaks of FMD  for the United States, Mexico, and Canada were in 1929, 1946, and 1952,  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.
However, in the United Kingdom, a major outbreak in 2001 resulted in  more than 6 million animals being slaughtered. Another outbreak in the  United Kingdom in 2007 resulted from an accidental release of FMD virus  at the Institute of Animal Health’s Pirbright Laboratory, leading directly to  eight separate outbreaks of FMD on surrounding farms that summer  (Pirbright Laboratory is near the village of Pirbright, near Guildford,  Surrey, just southwest of London). Both Pirbright Laboratory and Merial  Animal Health Ltd., a commercial vaccine production plant, are at  Pirbright and work with FMD virus. They are surrounded by a number of  “hobby farms,” where 40 to 50 cattle are bred and raised. In all, eight  separate outbreaks occurred over 2 months.
section_title: The Economic Consequences of an Outbreak
paragraphs: While FMD has no health implications for humans, it can have significant  economic consequences, as the recent outbreaks in the United Kingdom  demonstrated. The economic effects of an FMD outbreak in the United  States would depend on its characteristics and on how producers,  consumers, and the government responded. 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 and pork  producers whose animals would be at risk for diseases, depending on how  and where such an outbreak occurred.
section_title: Agriculture Biosafety Levels: Animals of Agricultural Significance
paragraphs: Risk assessment and management guidelines for agriculture differ from  human public health standards. Risk management for agricultural research  is based on the potential economic impact of animal and plant morbidity  and mortality and the trade implications of disease. Worker protection is  important, but great emphasis is placed on reducing the risk of an agent’s  escape into the environment. BSL-3-Ag is unique to agriculture because of  the need to protect the environment from economic, high-risk pathogens  where facilities study large agricultural animals or a facility’s barriers  serve as the primary containment.
BSL-3-Ag facilities are specially designed, constructed, and operated with  unique containment features for research involving certain biological  agents in large animal species. Specifically designed to protect the  environment, they include almost all features ordinarily used for BSL-4  facilities as enhancements. All BSL-3-Ag containment spaces must be  designed, constructed, and certified as primary containment barriers.  There may be enhancements beyond the BSL-3 and Animal Biosafety  Level-3 that USDA’s Animal and Plant Health Inspection Service may  require for work with certain veterinary agents of concern conducted in  primary containment devices (i.e., work with cultures or small animals).
subsections: section_title: The Plum Island Animal Disease Center
paragraphs: The PIADC is a federally owned research facility on Plum Island—an 840- acre island off the northeastern tip of New York’s Long Island. PIADC  scientists are responsible for protecting U.S. livestock against foreign  animal diseases that could be accidentally or deliberately introduced into  the United States. The PIADC’s research and diagnostic activities stem  from its mission to protect U.S. animal industries and exports from the  accidental or deliberate introduction of foreign animal diseases. USDA’s  scientists identify pathogens that cause foreign animal diseases and  develop vaccines to protect livestock at the PIADC. Its primary research  and diagnostic focus is foreign or exotic diseases that could affect  livestock such as FMD, classical swine fever, and vesicular stomatitis.
Because some pathogens maintained at the PIADC are highly contagious,  research on them is conducted in a biocontainment area that has special  safety features designed to contain them. Its BSL-3-Ag includes 40 rooms  for livestock and is the only place in the United States used to conduct  research on live FMD virus. Unique risks are associated with BSL-3-Ag  facilities because large animals are not handled within a biological safety  cabinet; they are free to move around within a room inside a laboratory- secured facility whose walls provide the primary containment.
Another important distinction in a BSL-3-Ag laboratory is the extensive  direct contact between human operators and infected animals. Because  the virus can be carried in a person’s lungs or nostrils or on other body  parts, humans are a potential avenue for the virus to escape the facility.
An additional key feature of FMD virus research is that because the virus  rarely causes infection in humans, FMD virus containment practices are  designed to protect susceptible domestic animals and wildlife rather than  humans from exposure to the virus. 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 at the PIADC.
section_title: DHS’s Reasons for Considering Relocation
paragraphs: DHS has stated that the PIADC is nearing the end of its life cycle and lacks  critical capabilities to continue as the primary facility for such work.  According to DHS, the nation’s national biodefense and agrodefense  capabilities are inadequate to meet future research requirements  supporting both agricultural and public health national security. Foreign  animal disease studies; public health threats from emerging, high- consequence zoonotic pathogens; and the need to develop and license  medical countermeasures have generated additional demands for  biocontainment laboratory space.
section_title: Legislation Allowing FMD Work on the Mainland
paragraphs: Until 2008, live FMD virus could by law be used only on a coastal island,  such as Plum Island, unless the secretary of Agriculture specifically  determined it necessary and in the public interest to conduct such  research and study on the U.S. mainland. Section 7524 of the Food,  Conservation, and Energy Act of 2008 directed the secretary of Agriculture  to issue a permit to the secretary of Homeland Security for work on live  FMD virus at any facility that is a successor to the PIADC and charged  with researching high-consequence biological threats involving zoonotic  and foreign animal diseases. The permit is limited to one facility.
section_title: DHS’s Site Selection Process for the NBAF
paragraphs: DHS began its site selection process for the NBAF with a solicitation of  expressions of interest for potential sites in Federal Business  Opportunities on January 17, 2006, and the Federal Register on January 19,  2006. Having received 29 submissions by the March 31, 2006, deadline,  DHS used four evaluation criteria to reduce the number of sites to 18: (1)  proximity of the suggested site to research capabilities; (2) proximity to  work force; (3) acquisition, construction, and operations requirements;  and (4) community acceptance. In the 2006 Federal Register notice, the  four evaluation criteria are described as follows.
Research capabilities include proximity to (1) existing research programs  (medical, veterinary, or agricultural) that can be linked to NBAF mission  requirements, (2) strength and breadth of the scientific community and  infrastructure, (3) ability of the proposed site and surrounding community  to absorb additional research programs and infrastructure, (4) experience  of existing research programs with BSL-3 or BSL-4 agents, (5) proximity to  other related scientific programs and research infrastructure, and (6)  proximity to vaccine industry capability.
Workforce includes proximity to (1) a critical mass of intellectual research  capacity, (2) recruiting opportunities for research staff, (3) local labor  force for operations staff with expertise in operating a biocontainment  facility, and (4) capability to meet mutual aid (police, fire services, or  hospital) requirements to operate the facility and meet physical security  requirements for a BSL3/4 facility.
Acquisition, construction, and operations include (1) land acquisition and  development potential to locate the facility, (2) access to the site by  highways and proximity to international airports, (3) environmental  compatibility with the intended use of the site, (4) adequate utility  infrastructure to support the operations of the facility, and (5) availability  of local labor force for construction.
Community acceptance includes letters of support for locating NBAF at  the site (i.e., local and state governments, national and local agricultural  producer and commodity stakeholders, industry, academia).
DHS conducted a further evaluation in the second round of the site  selection process, determining that five sites met the four evaluation  criteria, later adding the PIADC to the selections for a total of six sites for  consideration. The five other sites are in Athens, Georgia; Butner, North  Carolina; Flora, Mississippi; Manhattan, Kansas; and San Antonio, Texas.
DHS published a notice of intent to prepare an EIS and hold public  scoping meetings in the Federal Register on July 31, 2007. When it  published the draft NBAF EIS on June 27, 2008, a 60-day public comment  period began that ended on August 25, 2008; in that interval, 13 public  comment meetings were held. DHS’s analysis of the oral and written  comments yielded more than 5,000 delineated comments. Comments on  the NBAF draft EIS included the following concerns:  the ability of DHS and the federal government in general to safely operate  a biosafety facility such as the proposed NBAF;  the potential for a pathogenic release through accidents, natural  phenomena, and terrorist actions;    our May 2008 testimony that concluded that DHS had not conducted or  commissioned a study to determine whether FMD research could be  conducted safely on the U.S. mainland;    natural phenomena such as tornadoes, earthquakes, and hurricanes that  could cause catastrophic damage to the NBAF and result in the release of  a pathogen;  the possibility that an infected mosquito vector could escape, allowing a  pathogen such as Rift Valley Fever virus to become permanently  established in the United States;  the economic effects of a release or a perceived release on the local, state,  and national livestock industry.
In the notice of availability for the final EIS, published in the Federal  Register on December 12, 2008, DHS identified the preferred alternative as  the site at the university campus in Manhattan, Kansas. The record of  decision, published in the Federal Register on January 16, 2009, provided  DHS’s rationale for selecting this site for the NBAF.
section_title: Plume Modeling
paragraphs: The consequences of a release of an infectious agent from an HCL depend  on, among other things, the characteristics of the agent, the pathway on  which it is spread, and the size and characteristics of the population  exposed to it. Modeling is one way of assessing the extent of dispersion of  a virus and how the disease it causes may spread.
From analyses of models’ mathematical equations, plume modeling  provides information on the extent of dispersion from a release of a  pathogen or virus from the point of release. In emergency response, plume  models provide early estimates of potentially contaminated areas and are  used in combination with data gathered from the field. Several important  pieces of data are required for modeling. A comprehensive model takes  into account the material released, local topography, and meteorological  data, such as temperature, humidity, wind velocity, and other weather  conditions. Plume modeling requires the following:    meteorological data (temperature, humidity, barometric pressure, dew  point, wind velocity and direction at varying altitudes, and other related  measures of weather conditions);    data from global weather models to simulate large-scale weather patterns  and from regional and local weather models to simulate the weather in the  area of the agent release and throughout the area of dispersion;  the source term, or the characteristics or properties of the material that  was released and its rate of release (for example, its quantity, vapor  pressure, the temperature at which the material burns, particle size  distribution, its persistence and toxicity, and the height of release); and  information on the potentially exposed populations, such as dose response  (conversion of exposures into health effects), animals, crops, and other  assets that the agent’s release may affect.
Figure 1 shows the flow of data inputs and outputs from plume modeling.
section_title: DHS Used Evidence from Four Types of Analysis
paragraphs: DHS used evidence from several analyses it conducted to compare  differences across sites. The primary analyses and conclusions were as  follows:    From a hazard and accident analysis, DHS identified seven accident  scenarios—representative of NBAF operations—of an FMD virus release;  from the results, DHS concluded that the risk of each accident’s occurring  was low and primarily independent of the site, with the potential impact of  a release slightly less at the Plum Island site than at the others.
Its modeling of each accident scenario, using straight-line Gaussian plume  modeling, led DHS to conclude that the sites differed very little in the  dispersion of FMD virus and that the risk of FMD virus and other  pathogenic releases from the laboratory at the sites was very low and  independent of the NBAF’s location.
From the BKC’s economic impact analyses of the potential impact of an  outbreak associated with a release in the vicinity of each site, its literature  review, and the EIS, DHS asserted that the major effect of an FMD release  would be an export ban on U.S. livestock products, regardless of the site’s  location, with total costs of the same magnitude for all six sites.
From a threat and risk assessment, developed separately from the EIS,  DHS concluded that, when considering the incorporation of system  recommendations to mitigate identified differences in risk, the sites  differed little in terms of threats and vulnerabilities, such as terrorism or a  compromised or disgruntled employee’s releasing viruses, and that all sites  had acceptable security risks, with or without mitigation.
subsections: section_title: Hazard and Accident Analysis Identified Seven Scenarios for FMD Virus Release
paragraphs: To determine the potential health and safety risks during the operation of  the proposed NBAF, DHS conducted a hazard and accident analysis,  focusing on pathogen handling, hazards related to the operation of any  HCL, and the prevention or mitigation of accidents that could lead to  outbreaks of disease in livestock, wildlife, and humans. The analysis was  intended to assess the probability of the occurrence and consequences of  adverse events involving a potential release of viral pathogens from the six  proposed sites by  1.  operational accidents such as spills from dropped containers and  2.  external events such as an airplane crash into the facility,  3.  natural phenomena such as an earthquake, or  4. intentional acts, such as terrorism or a compromised or disgruntled  employee’s purposefully releasing pathogens.
The viruses selected for assessment were FMD, Rift Valley Fever, and  Nipah.
DHS’s hazard and accident analyses began with identifying a wide range of  hazard scenarios, screening the hazards for those that presented the  greatest potential consequences to workers and the public, selecting  accidents from the screened hazards for detailed evaluation, and then  developing credible scenarios for the chosen accidents involving the  release of a virus that could result in exposure and ultimately an adverse  effect. DHS selected eight accident scenarios as representing NBAF  operations and producing “bounding” consequences. The seven of the  eight scenarios that could result in an accidental release of FMD virus are  shown in table 1.
section_title: DHS’s Plume Modeling Determined the Extent of FMD Virus Dispersion
paragraphs: DHS used a simple straight-line Gaussian plume model to determine the  extent of FMD virus dispersion, based on meteorological and source term  data, and the potential downwind exposures from the accidental release  scenarios for each of the six sites. The Gaussian plume model has been  widely used to support probabilistic risk assessments for the nuclear  power industry in modeling the dispersion of radiological aerosols for  distances up to 10 kilometers. The model evaluates concentration levels  from the accidental atmospheric releases of radio nuclides. DHS used a  Gaussian plume model to determine the dispersion of FMD and other  viruses from a hypothetical release.
Several important pieces of data are required for modeling, including local  meteorological data (wind direction and speed, humidity), source term  (the quantity and particle size of FMD virus released), time of release (day  or night), and the decay rate of the virus (measure of time in which the  virus would remain viable).
Meteorological and source term data are particularly critical inputs for  modeling the dispersion of any pathogen. For meteorological data, DHS  modelers used a year’s worth of hourly averaged meteorological data to  determine the probability that areas away from the release site would be  affected by the plume. Different calendar years were used for the sites. For  four of the sites, 1991 meteorological data were used; 1990 data were    used for New York and 1992 data for Mississippi. According to DHS  contractors who conducted the modeling, they used National Oceanic and  Atmospheric Administration (NOAA) weather data and they were the best  and most complete weather data available.
DHS developed a different source term for each scenario. DHS’s modelers  calculated the amount of respirable aerosol released to the environment  from a given accident, using a five-factor formula. For the accident  scenario of a release of viruses from a spill, the EIS estimated that a  particular package of biological material could contain approximately 100  milliliters of culture containing viable viruses and that 1 × 10 viable  virions, or virus particles, could be present in a single ml of culture media.  The amount of aerosol release for a spill accident for the NBAF was  estimated to be 1 × 10–4, while the respirable fraction was conservatively  taken to be 1.0.
With these inputs, the Gaussian plume model performed the calculations  to produce estimates of the downwind dispersion of FMD virus from a  hypothetical release up to the limit of the model—that is, 10 km from the  point of release for each of the seven accident scenarios. Potential  dispersion was characterized as the estimated time-integrated, downwind  air and ground concentrations of virus particles at various distances from  the point of release for a site. According to DHS, conservative estimates of  viral pathogen quantities were modeled and based on the 95th percentile  of the distribution of concentrations at a specified downwind location. In  the case of FMD, an infection is considered to result from a very small  number of virions—10 infectious particles constitute the minimum  infectious dose. The results of the modeling are shown in table 2.
DHS’s modeling results for the spill scenario showed estimated air  concentrations that did not differ significantly from site to site. For  example, as shown in table 2, at 50 meters from the spill the Georgia and  North Carolina sites had estimated air concentrations of 93,400 virions and  81,100 virions, respectively, whereas Kansas, Mississippi, Texas, and New  York–Plum Island all had estimated air concentrations of 161,000 virions.  DHS concluded that because modeling results showed the Kansas,  Mississippi, Texas, and New York–Plum Island sites as having the same air  concentration levels, there would be little differentiation among the sites.
section_title: The BKC Conducted Economic Analyses to Determine the Impact of a Release
paragraphs: The BKC conducted a quick and limited analysis of the potential economic  consequences of an accidental FMD outbreak at the six sites. DHS also  reviewed the literature on simulated outbreaks in the United States and  previous outbreaks of FMD virus in other countries to determine the upper  and lower bounds of potential economic losses from an outbreak. From  the results, DHS concluded that an export ban would be the primary  economic impact, with total costs of the same magnitude for all six sites.
The May 29, 2008, economic analysis that the BKC performed was  unrelated to the accident scenarios and associated plume modeling  analysis presented in the EIS. In its analysis, the BKC used an  epidemiologic and economic simulation model to evaluate the potential  impacts of seven accidental release scenarios—or outbreaks (see table 3).  It also performed an assessment of an aerosol release in the vicinity of the  six sites. The epidemiological analysis of the outbreak scenarios showed  that simulated outbreak durations for an initial, single random release in  county livestock premises were comparable across all proposed sites. The  potential impact by number of infected animals was largest for simulated  outbreaks beginning in Kansas and North Carolina and smallest for those  beginning in New York—the Plum Island site. For numbers of herds  infected, Kansas had larger outbreaks and New York and Texas had  smaller outbreaks. The qualitative assessment of the aerosol release  showed that a release from the Kansas site would have the greatest impact  and a release from the Plum Island site would have the least impact.
The overall economic impact in the BKC analysis included estimates of (1)  foreign trade lost because of the duration of export bans; (2) disruption to  industry, or indirect costs; and (3) costs to government, or direct costs.  Given the outbreak scenarios, the economic impact analysis showed that  Plum Island would produce the least overall economic impact, at $2.8  billion, compared to the mainland sites, with the Kansas site having the  greatest impact, at $4.2 billion. Because the simulated outbreaks were  short and relatively small, the loss of foreign trade from an export ban was  identified as the main economic impact for the six sites.
According to DHS, it concluded from the final EIS, the BKC’s economic  analysis, and its literature review that the primary economic effect of an  accidental release would be from a ban on exporting U.S. livestock  product, regardless of the location of the accidental release. DHS  concluded that losses could reach as high as $4.2 billion—the potential  total costs of an outbreak for the Kansas site—until foreign trade could  resume.
section_title: DHS Conducted a Threat and Risk Assessment to Determine Security Risks
paragraphs: DHS developed a threat and risk analysis independent of the EIS that  identified and evaluated potential security risks—threats, vulnerabilities,  and consequences—that might be encountered in operating the NBAF.  They included crimes against people and property and threats from  compromised or disgruntled employees. The objectives of this analysis  were to present the risks and effective mitigation strategies for ensuring  the NBAF’s secure operation and to help DHS select the site with the  fewest unique security threats.
DHS concluded that the EIS and threat and risk analysis showed very little  differentiation across the six sites and considered that the safety and  security risks that had been identified at all sites were acceptable, with or  without mitigation. Specifically, for all sites the risk was zero to low for all  accident scenarios, except for an overpressure fire—an explosion from  the buildup of a large amount of gas or flammable chemical in an enclosed  area. The risk of an overpressure fire accident was moderate for all sites.
For all sites—except Plum Island—the overall risk rank was moderate,  based on the potential for infection and opportunity for disease to spread  through livestock or wildlife. The Plum Island site’s overall risk rank was  low, because the likelihood of any disease spreading beyond the island  was small, since animals do not live in the vicinity and the potential for  infection is less.
The threat and risk assessment concluded that the insider threat would be  the biggest threat to the NBAF and would be independent of the site.  However, DHS asserted that this and other vulnerabilities it identified  would be mitigated by implementing security measures described in the  EIS as well as operational protocols and by adhering rigidly to standards  for safe operational practices, including those in Biosafety in  Microbiological and Biomedical Laboratories, issued by the Centers for  Disease Control and Prevention and National Institutes of Health. Figure   Figure  2 summarizes DHS’s conclusions from its analyses.  2 summarizes DHS’s conclusions from its analyses.
section_title: Our Assessment of DHS’s Analyses of Plume Modeling, Economic Impact, and Security Issues
paragraphs: We identified several limitations in the analyses from which DHS reached  its conclusion that FMD work can be done as safely on the mainland as on  Plum Island. We identified several limitations in the plume modeling and  the economic analysis, and we found that DHS did not integrate the  modeling and economic analysis. In addition, DHS’s analyses showed little  differentiation of risks across sites.
subsections: section_title: Limitations in Plume Modeling
paragraphs: We found at least two limitations in the plume modeling. (1) The simple  straight-line Gaussian plume model DHS used for accident analyses was  not appropriate for determining the extent of the dispersion of an FMD  virus release. The model has significant limitations for tracking the  dispersion of biological materials from an accidental release. While this  model has been widely used to support probabilistic risk assessments for  the nuclear power industry in modeling the dispersion of radiological  aerosols, it has not been validated for modeling FMD virus. Despite the  lack of validation, this model was used to study FMD virus dispersion, as  noted in the EIS. Using other available models would have been more  appropriate, such as the RIMPUFF, a local-scale puff diffusion model  developed by Risø National Laboratory for Sustainable Energy in  Denmark. (2) Assumptions about the meteorological data and source term  introduced errors that may have influenced the final results. In addition,  DHS did not model the spread of FMD after infection.
section_title: The Gaussian Plume Model Is Not Appropriate for Determining FMD Virus Dispersion
paragraphs: According to DHS, the U.S. Department of Energy, the Environmental  Protection Agency (EPA), and the Nuclear Regulatory Commission,  various handbooks, guides, and standards are available on the use of  Gaussian plume models for downwind concentrations of hazardous  constituents resulting from an accidental release. While the Gaussian  plume model has been widely used in supporting probabilistic risk  assessments for the nuclear power industry to model the dispersion of  radiological aerosols, it has not been validated for modeling FMD virus  and it has significant limitations for determining FMD virus dispersion.  Gaussian plume models typically use only a single constant wind velocity  and stability class to characterize turbulence diffusion. It is recognized  that they treat horizontal dispersion satisfactorily but do not provide good  predictions for vertical movement.
Gaussian plume models have been applied to estimate downwind  concentrations of physical particles, but they have rarely been used for the  dispersion of biological materials because the models, including the  MACCS2, lack a mechanism to input biological decay rates. They are  usually used to predict the dispersion of continuous buoyant air pollution  originating from ground level or elevated sources, primarily single puff  source releases. Gaussian plume models also assume that particle  dispersion follows a Gaussian distribution, meaning that particles at the  source have a normal distribution. The most appropriate use for straight- line Gaussian plume models is continuous releases of a constant source  strength and uniform wind field. They can be reasonably reliable over  short ranges (up to 10 km) in situations involving homogeneous conditions  and simple flows, such as unidirectional steady state flow over relatively  flat terrain. They do not model dispersion less than 100 meters from the  source or long-range dispersion. The models start to break down in  predictive capability when meteorology and source strength change over  long time periods.
DHS’s experts who reviewed the NBAF EIS methodology questioned the  use of Gaussian plume models and identified limitations in their use for  FMD virus release. We describe three. First, in an analysis conducted for  DHS on the potential impact of an accidental release of FMD virus from  each of the proposed sites, LLNL modeling experts stated that “given the  location of the proposed sites, the likely range of release scenarios, and  the distances to be considered, a simple straight-line Gaussian model may  be insufficient to characterize the downwind impacts of an FMD virus  aerosol release.” LLNL modeling experts also said that no established  models had been validated for tracking FMD virus releases.
Second, the Johns Hopkins University Applied Physics Laboratory’s  review of aerosol calculations from the draft EIS noted that while a  Gaussian model is appropriate for a risk assessment of this type, it does  not provide suitable information for modeling the effects of a specific  release event. In the event of an actual release, mapping the plume effects  effectively would require more sophisticated models and high-resolution  meteorological data to determine the dispersion. It also noted the  significant skepticism in the aerosol modeling community at the ability of  Gaussian plume models to adequately represent the effects of turbulent  transport on the dispersion of the plume. Gaussian plume calculations  should be interpreted as representing estimates of areas affected by a  hypothetical release, not an absolute or definitive result.
Third, Massachusetts Institute of Technology’s (MIT) Lincoln Laboratory’s  review of the NBAF methodology stated that models such as the U.S.  Department of Defense’s Hazard Prediction Assessment Capability  (HPAC) model, rather than the MACCS2 model, is typically used to model  the dispersion of biological material. Lincoln Laboratory stated that it is  unclear how the MACCS2 model compared to these standard models. The  Hazard Prediction and Assessment Science and Technology Manager at  the Department of Defense’s Defense Threat Reduction Agency also  informed us that for long-range dispersion, a model such as HPAC would  be more appropriate. While HPAC has not been validated for modeling  FMD, long-range transport, which would include terrain effects and  variable wind fields, could provide a good reality check. More advanced  models could track the virus environmental decay and deposition. More  important would be the spread of FMD through the livestock population  after the initial infection.
Modeling experts in Denmark told us that a few models have been  validated for FMD dispersion. An example is the RIMPUFF, a local-scale  puff diffusion model developed by the Risø National Laboratory for  Sustainable Energy in Denmark. RIMPUFF is an emergency response  model to help emergency management organizations deal with chemical,  nuclear, biological, and radiological releases to the atmosphere. It is being  used in several European national emergency centers for preparedness  and in the prediction of nuclear accidental releases (RODOS, EURANOS),  chemical gas releases (ARGOS), and airborne FMD virus spread.
RIMPUFF builds from parameterized formulas for puff diffusion, wet and  dry deposition, and gamma dose radiation. Its range of application is  about 1,000 km from the point of release. RIMPUFF calculates  instantaneous atmospheric dispersion, taking into account local wind  variability and local turbulence levels. The puff sizes represent  instantaneous relative diffusion (no averaging) and are calculated from  similarity scaling theory. Puff diffusion is parameterized for travel times  from a few seconds up to about a day. Wet and dry deposition is also  calculated as a function of local rain intensity and turbulence. Models like  RIMPUFF are superior to Gaussian models because they apply local wind,  precipitation, and turbulence data and sophisticated scaling theory and  because puff diffusion can be calculated on many time scales. RIMPUFF  also applies biological decay rates for FMD.
section_title: Assumptions about Meteorological and Source Term Data May Have Introduced Errors That Influenced the Modeling Results
paragraphs: DHS’s assumptions about model input parameters, including the  meteorological data and the source term, may have introduced errors that  influenced its final results. These include the local meteorological data  (wind direction and speed, humidity), source term (the quantity and  particle size of FMD virus released), and the decay rate of the virus (time  in which the virus would remain viable).
subsections: section_title: Meteorological Data
paragraphs: Meteorological phenomena drive the direction and potential dispersion  range of aerosolized FMD virus. DHS concluded that because its modeling  results showed Kansas, Mississippi, Texas, and New York–Plum Island  with the same air concentrations, they differed little on meteorology.  However, the Gaussian plume model used a year’s worth of hourly  averaged meteorological data rather than actual data for each site to  determine the probability that the plume would affect areas away from the  release site. As a result, any differences between the sites with regard to  meteorological conditions were minimized.
Factors influencing the downwind concentration of FMD virus include  wind speed, atmospheric stability, topography where the release occurred,  and wet and dry deposition. For atmospheric stability, the Gaussian plume  model uses Pasquill stability categories to determine vertical and  horizontal plume dispersion. The more stable the atmosphere is, the less  vertical and horizontal dispersion there will be and, therefore, the higher  the concentration of particulates will be. However, according to experts  we consulted, most advanced models do not use Pasquill stability  parameters because they are based on simple meteorological parameters  and do not provide the detail observed with other tools. When using the  Gaussian dispersion model, the availability of meteorological data is  crucial in determining the Pasquill stability category. If the meteorological  data are collected from a station at a significant distance from the area  being modeled, then significant errors may arise.
Meteorological data were collected not necessarily from the sites’ nearest  meteorological measurement location. For example, for Plum Island, the  meteorological data were from what the EIS stated was the closest  available location—a mainland site in Islip, New York (about 58 miles  from Plum Island). However, according to the NOAA, two weather stations  in West Hampton and Shirley/Brookhaven, New York, are closer. Winds  and temperature data from Islip were used as input for dispersion  modeling at Plum Island. The same Islip data were used to calculate  Pasquill stability classes at Plum Island, even though Islip is inland on  Long Island. DHS acknowledged that the Brookhaven and West Hampton  stations are closer but noted that they are also on Long Island. DHS  determined that without a station on Plum Island, the Islip, New York,  station is sufficient when compared to the two other Long Island weather  stations. Nevertheless, when sites surrounded by water are modeled, every  effort should be made to collect the appropriate meteorological data and  not assume that conditions are similar at sites separated by significant  distances with different geographic characteristics. Crucial errors for  downwind particle (virus) concentrations may result from models in  which inappropriate stability classifications are applied.
The wind rose—a graphic representation of the direction and velocity of  the wind—is an important meteorological tool because it can help  determine wind direction and speed at a given site. According to NOAA,  official wind rose data were not used for Plum Island. The hourly averaged  meteorological data used in the model give long-term averages for wind  direction but cannot account for variations in velocity. Therefore, the data  were not representative of the prevailing wind directions at the sites and  did not take into account the season or time of day.
Wind rose data as meteorological input to transport and dispersion models  are, however, sensitive to the proximity of the release (and evolving cloud)  to the observational sites and, hence, ultimately limited by the density of  the observational network. Moreover, analyses (for example, wind fields)  based on such statistical quantities do not exhibit dynamic consistency  and, because of the coarseness of the data, cannot be expected to resolve  small-scale processes, which may be very important for highly variable  environments.
Recent developments in mesoscale climatology have significantly  enhanced analysts’ ability to produce statistically distributed weather data  characteristics for any location in any season at any time of day. The  National Ground Intelligence Center of the U.S. Army, in collaboration  with the National Center for Atmospheric Research (NCAR), has  developed the Global Climatological Analysis Tool for generating fine- scale (about 1 km) climatological analyses anywhere around the globe. It  applies  1.  Penn State University’s NCAR Mesoscale Model version 5 (MM5)– based, Real-Time Four-Dimensional Data Assimilation system;  2.  the National Centers for Environmental Prediction–NCAR Reanalysis  Project 2.5 degree, 40-year gridded model dataset for initial and  boundary conditions; and  3.  observations from the National Centers for Environmental Prediction’s  Automatic Data Processing historical repository.
In a typical application—as in defining meteorological characteristics  associated with a typical day in June in the Plum Island area—Climate- Four Dimensional Data Assimilation mesoscale downscaling is performed  for each of the past 40 years. Each model run resolves fine-scale  meteorological processes over a month-long period for the year being  studied. These reanalyses are combined statistically to produce a “typical  day” (that is, 24-hour output fields that describe the diurnal variation of  weather) by using an ensemble mean. If the mean is not representative of  typical climatological conditions, then clustering methods are used to  identify several “typical” conditions characterizing the predominant  regimes.
To determine the potential risk associated with the release of hazardous  material into the atmosphere, HPAC, a probabilistic dispersion model, is  used with the ensemble mean fields from the individual atmospheric  dynamic runs, including the variability in the individual wind fields, to  generate dosage probabilities. Additionally, HPAC-explicit dosage  probabilities may be derived from individual runs over a month’s time with  an MM5–HPAC modeling system. In this way, the modeled transport and  dispersion of hazardous material reflect both the frequency distributions  of atmospheric states and the fine-scale processes known to drive local  hazard levels.
In addition, as we previously noted, Gaussian plume models typically use  only a single constant wind velocity and stability class to characterize  turbulence diffusion. Gryphon Scientific’s review of the EIS pointed out  that the tendency of the wind to push aerosol releases (and light insects,  such as mosquitoes) in a particular direction should influence the impact  from each event at each site. If the wind generally blew away from the  counties with large livestock concentrations, it would reduce the  probability-weighted impact from an aerosol release of these viruses.  Gryphon noted that if the wind tends to blow out to sea from Plum Island,  the probability-weighted impact from an aerosol release at this facility  would be greatly reduced, whereas if it generally blew into the dairy land  on Long Island, the risk would be amplified. If the weather is  unpredictable or highly variable, the increase or decrease in risk would be  less a factor.
section_title: Source Term Data
paragraphs: DHS modelers calculated the source term Q—amount of respirable  aerosol released to the environment from a given accidental incident— using the following five-factor formula:  Q = MAR × DR × ARF × RF × LPF  1.  MAR (or material at risk) is the amount of biological material available  from an accidental release,  2.  DR (or damage ratio) is the fraction of material that is affected by the  3.  ARF (or aerosol release factor) is the fraction of MAR × DR that is  4.  RF (or respirable fraction) is the fraction of the airborne material that  is in the respirable range or less than 10 micrometers, and  5.  LPF (or leak path factor) is the fraction of aerosolized material  released into the environment.
Together, the product of MAR and these factors would determine the  amount of material released to the atmosphere at an NBAF site. This  quantity is used in conjunction with the breathing rate of potentially  exposed humans or livestock to determine the level of exposure at a  distance from the release site.
DHS’s assumptions about the source term for the spill scenario illustrate  the limitations of its analyses. This scenario considers the release of  viruses from a small to medium spill. This accident is considered to have  been caused by a storage-container handling accident—specifically, a  dropped container or equipment failure that results in the contents having  been spilled or sprayed, released, and aerosolized. For the spill accident  scenario, the EIS made assumptions that “based on mission objectives and  regulatory requirements,” a package of biological material could contain  approximately 100 ml of culture containing viable viruses and that 1 × 10 virions per ml is a conservative value for  production concentrations of viruses in stock solutions. Initial  concentrations of viruses grown in laboratories typically range from 10 to  10 viruses per ml. Viruses, after production but before being used or  stored, are typically concentrated at values as high as 10 ml or 10 ml,  depending on the virus size and other factors. Danish scientists who work  with FMD virus told us that their production concentrations are typically  10 to 10  DHS modelers also stated in the EIS that one of the critical assumptions  for estimates of the amount of material available from an accidental  release was that the material form is of a solution with the assumed  density and viscosity of water. The EIS noted that this is a highly  conservative assumption, since most viruses are stored, grown, and  handled in gelatin or agar whose densities are often greater than that of  water, with a viscosity much greater than that of water. However,  according to experts we consulted, in practice only a few viruses are  grown in agar or gelatin, and essentially no viruses are stored or handled  in agar or gelatin, and hence the appropriate density to apply to  calculations is the density of water (not a highly conservative assumption).  Gryphon Scientific’s review of the EIS also stated that animal viruses are  not stored, grown, and handled in gelatins or agars, since these substances  are used for applications other than stock production or maintenance.
The EIS stated that the aerosol release factor is one of the most important  model inputs in analyzing a potential release and subsequent exposure to  biological viruses. Determining it depends on the type of material, the  physical form, and specific characteristics such as density and viscosity;  according to the EIS, it was based on “conservative estimates” for these  physical and chemical characteristics. The aerosol release factor value for  a spill accident for the NBAF was estimated to be 1× 10–4. However, this  estimate referred to values that were calculated from data collected after  the anthrax letter attacks on the U.S. government and others in 2001. This  raises four issues.
First, the generation of dry aerosols from a letter has little in common with  aerosols generated by laboratory accident. Gryphon Scientific’s review of  the EIS questioned the calculation of an aerosolization factor from the  amount of material retained in envelopes compared to the amount that  escaped during the anthrax incidents in 2001. Gryphon pointed out that  the relatively small fraction of powder that was converted into an aerosol  was partly powder trapped in the envelopes. Dropping the same material  from a height of 1 meter would be likely to result in an aerosol fraction  much greater than 10–4.
Second, the Bacillus anthracis spores were sampled days after the 2001  attack, when the particles originated primarily from follow-on  reaerosolization. The result was an underestimation of the initial cloud  concentration.
Third, the Bacillus anthracis spores were not used as weapons (no  additives were found) but were washed, so that they tended not to stick  together.
section_title: Decay Rate
paragraphs: Decay rate can be an important model input. Lincoln Laboratory’s review  of the EIS questioned how the Gaussian plume model accounts for  biological decay, modeled in HPAC but not in the Gaussian model. The EIS  stated that the Gaussian model can account for decay of viruses over time  but that this was “conservatively not used.” DHS assumed a zero decay  rate, meaning that all viral particles released would be viable at whatever  distance they were dispersed—up to the limit of the model.
DHS’s modelers assumed that any pathogen that is released will be  transported downwind and available to a potential host. However, the  aerosol survival of FMD virus has been found to depend greatly on  temperature and relative humidity. Generally, relative humidity levels  above 55 percent, cool temperatures, and neutral or slightly alkaline  conditions favor prolonged survival of FMD virus in infective aerosols and  on fomites. DHS’s modeling applied very conservative values, not  accounting for biological decay presumably because the model was not  equipped for this treatment. Had DHS applied appropriate decay rates, it  would have observed fewer viable viruses at increasing distances from the  source.
section_title: DHS Did Not Model the Spread of FMD after Infection
paragraphs: DHS did not capture site-specific differences in its modeling analysis.  Gryphon Laboratory’s review of the EIS pointed out that sites can differ  significantly in, among other things, availability of suitable vector species,  density of susceptible wildlife, density of population, and significance of  local agricultural activity. Gryphon noted further that the EIS did not  analyze what would happen after an outside animal or person became  infected from a release (as from an aerosol, infected work, or escaped  animal). LLNL and USDA experts similarly noted that the critical,  unaccounted for, component needed for the risk assessment is an estimate  of the likelihood that an actual FMD virus release would lead to the  infection of at least one animal at one facility. The local availability of  suitable vector species, density of local livestock, and interconnectedness  of local agricultural facilities would all significantly change the impact  from a release that infected the same number of animals at every site.
However, in evaluating the site-specific consequences of an FMD virus  release, DHS did not use additional data such as the number and type of  susceptible livestock in the vicinity of the release, the decay rate of the  organism, and certain types of meteorological data, along with the  postulated release scenarios to conduct epidemiologic and economic  analyses. These data inputs would have provided information for modeling  the extent of potential exposure and likely disease and could have helped  determine the economic consequences of an outbreak under the various  scenarios. According to the EIS, the release of a minimum of 10,000 virions  is needed before the possibility of multiple infections downwind of the  release becomes credible.
As DHS acknowledged in its EIS, information on the presence of grazing  livestock and crops to support them is critical to understanding potential  infections from an FMD virus release. DHS stated that its site-specific  evaluations factored in the details of nearby terrestrial wildlife and  livestock as a prime candidate for acquiring or transmitting FMD virus.  The proposed NBAF sites, with the exception of Plum Island, provide  significant opportunity for its spread by infected wildlife or livestock.
To determine whether a release of FMD virus could spread and become  established in the area of an NBAF site, DHS coupled the Gaussian plume  modeling results on the dispersion of air and ground concentrations of  virus particles with data on the distribution of livestock in counties in the  vicinity of all NBAF sites except Plum Island, which contains no livestock.  Using the air and ground concentrations of virions determined by the  Gaussian plume modeling, DHS depicted the distribution of virus particles  by “radial symmetry,” or concentric circles drawn around a site from  distances of 50 meters up to 10 km—the limit of the plume model. This  depiction, however, does not reflect an actual downwind plume model  result. Figure 3 shows DHS’s depiction of the far field effects of a potential  release of a virus and downwind transport surrounding the Manhattan,  Kansas, site in terms of normalized time-integrated air and ground  concentrations.
DHS concluded that except for Plum Island, each site is in an area where  the wildlife, vegetation, agriculture, and human population would provide  ample opportunity for the three pathogens to become established and  spread, once released from an NBAF. The EIS stated that Plum Island  provides a barrier against the spread of viruses, as well as protective  features against the spread of pathogens: the island is 2 km from the  mainland. At this distance, the normalized air concentrations fall, so that  the quantity of material released has to be much greater than 10,000  virions before there is significant potential for infection. Table 4 lists  livestock populations within 10 km of each proposed NBAF site. Plum  Island has no livestock and limited wildlife. The five other sites have  livestock densities that range from 0 to 30 livestock (mostly cattle) per  square km for the North Carolina site up to 20 to 50 livestock per square  km for the Kansas site.
section_title: DHS’s Estimate of Economic Impact Was Based on Limited Analysis
paragraphs: DHS asked the BKC to conduct quick and limited economic analyses of  the potential consequences of an accidental FMD virus outbreak at each  site, which it did on May 21 and May 23, 2008. In addition, DHS conducted  a literature review of simulated or previous outbreaks of FMD virus in  other countries. From the BKC analyses, DHS’s literature review, and the  final EIS, DHS concluded that the primary economic effect of an FMD  virus release would be an export ban on U.S. livestock products,  regardless of the NBAF’s location. However, we found several weaknesses  in the economic analyses. For example, they (1) did not incorporate  market response to an FMD outbreak or consider the effect of establishing  a containment zone to moderate the costs of the export ban and (2) were  constrained by the limited outbreak scenarios used and the lack of detail.  Recognizing the limitations of its analyses, the BKC recommended  additional analyses. Also, the literature review did not provide information  related to a release from the planned NBAF at any of the six sites.
The BKC analyses accounted for expected economic losses, based on  prerelease market conditions for affected species. However, both supply  and demand for livestock products would be likely to change after FMD  was detected for the expected species and other types of food animals.  Considering market responses to the detection of FMD and the subsequent  imposition of an export ban would affect the estimate of the overall costs  of an outbreak. Since losses from export sales would be offset by domestic  purchases (at lower prices) and by consumers’ substituting unaffected  animal products (say, chicken for pork), prices and revenues to producers  of the substitutes could rise. In comparison to those of BKC, in an analysis  in which market responses were incorporated, the relative rankings of the  total costs of releases across mainland sites could vary.
Containment zones are used to control the impact of export restrictions. If  and when country animal health officials can demonstrate an effective  FMD containment zone, exporting livestock products from the rest of the  country may resume. OIE, an international organization that confirms the  situation of a country with respect to FMD, states that the extent of a zone  and its geographic limits should be established on the basis of natural,  artificial, or legal boundaries and should be made public through official  channels. In this regard, the BKC’s analyses recognized that establishing  a containment zone is likely to be more straightforward for an island but  did not consider the possibilities for the other sites in its preliminary  studies. As a result, DHS did not consider differences across sites with  regard to establishing containment zones and the potential economic  effects of a release.
If national exports were to be banned, the effects on the domestic  livestock industry would vary little by site. No matter where a release  occurred, all export sales would be lost. The impact on exports would not  permit discrimination across sites. If a containment zone was established,  however, fewer exports would be affected than under a national ban.  Imposing a containment zone restricts animals within it, and exported  products must be shown to come from animals outside the zone. The  fewer animals within the containment zone, the smaller the potential  impact on exports. To the extent that a release on an island might permit  defining a smaller containment zone and involve fewer animals (or not  affect animals at all) than a release at a mainland site, the losses from an  island release could be smaller. Estimates of the potential impact of  establishing containment zones with less comprehensive export bans  could help differentiate NBAF sites.
DHS cited a November 2008 letter from OIE’s director general that stated  that differences in the national impact of an outbreak relate more to how a  country’s authorities respond than to where the outbreak occurs. While we  agree that the effectiveness of a country’s response is paramount, we  believe that where an outbreak occurs is also significant. Building FMD  scenarios that take into account geographic and animal demographic  factors could reveal whether there is an advantage to sites where  developing a containment zone may be facilitated by unique  characteristics, such as its being an island.
The BKC analyses were constrained by the limited outbreak scenarios,  lack of detail, and use of a more detailed dispersion model. They did not  incorporate the accident scenarios in the EIS—considered worst-case  scenarios—or the results of the plume modeling of those scenarios. Also,  for the outbreak scenarios used in the analyses, the relative susceptibility  of the various animal species or animals kept indoors was not considered.  An outbreak could be more or less costly depending on the type of animal  infected. For example, since it is more difficult to detect the disease in  sheep than in cows, FMD could spread farther in sheep, creating an  outbreak of greater magnitude. The analyses also lacked information on  the FMD virus source term (numbers and species shedding virus at the  time of the outbreak by serotype), meteorological conditions, and virus  decay rate in the environment. The BKC study noted that a more advanced  meteorological and dispersion model would be needed to quantify the  relative rankings of potential impacts for the sites.
Scenarios also lacked large-scale outbreaks of longer duration. The FMD  virus outbreak scenarios in the BKC analyses were short, averaging 44 to  51 days, and relatively small in scale. However, the domestic impact could  be greater than loss from an export ban if a large number of animals were  infected over a large geographic area for a longer period. Analyses of  scenarios involving larger outbreaks, in addition to incorporating worst- case scenarios in the EIS, would have provided additional information on  the domestic impact of an FMD virus release and, thus, the relative  differences across the sites.
The BKC analyses showed that an off-site impact of an aerosol release  would be highest for Kansas and lowest for Plum Island, but the analyses  were unable to distinguish between the impacts of the four other proposed  sites. Livestock density within the area affected the overall economic  impact for all scenarios in the BKC analyses, with Plum Island possessing  an advantage over the mainland sites because of the lack of livestock in  the vicinity. For example, for the aerosol release of FMD virus, the BKC  used two measures: the total number of susceptible animals and the  number of cattle facilities larger than 500 head. For the Kansas site, the  high impact stemmed from the high numbers and densities of susceptible  animals and the largest numbers of markets and large swine facilities  surrounding the site; in contrast, the low impact for Plum Island stemmed  from the small numbers and densities of animals surrounding the site.
As shown in figure 4, for the average estimated economic impact of a  single random introduction of FMD virus in the counties surrounding the  proposed NBAF sites, indirect costs in the form of industry disruption  showed the greatest variance across sites, ranging from a little over $1  billion for the Kansas site to as little as $31 million for the Plum Island site.  The overall impact in the economic analyses included estimates of (1)  foreign trade lost during an export ban; (2) disruption to industry, or  indirect costs; and (3) costs to government, or direct costs. Plum Island  also had the least overall economic impact, at $2.8 billion, compared to the  mainland sites, with the Kansas site having the greatest overall impact, at  $4.2 billion.
The analyses were also constrained by the lack of precise information on  the locations of animals in the counties surrounding the sites. As we have  reported, data limitations make it difficult for any computer modeling  effort to accurately predict the spread of disease. Modelers must  estimate the number and location of animals, as well as their interaction  with other segments of industry, because the United States does not have  a national mandatory system that identifies the location and tracks the  movement of livestock. Modelers currently use county-level agriculture  census data from USDA’s National Agricultural Statistics Service (NASS)  (conducted every 5 years), possibly reducing the accuracy of predictions  about FMD’s spread if animal presence changes markedly. Without  knowing the exact location of livestock, it is difficult to understand its  interaction with wildlife.
We have also reported that limited information on the number and  movement of wildlife and its susceptibility to the virus further complicates  matters. This is an important gap, since FMD is known to have spread  from livestock to wildlife in past outbreaks. The last time the United States  had an outbreak, in California in the 1920s, the virus spread from pigs to  cattle and black-tailed deer. It took 2 years and the slaughter of 22,000  deer to eradicate the disease from a local deer population in one national  park. Interaction may be possible with susceptible species, such as deer  and wild pigs, where livestock graze extensively.
The BKC recognized that its May 2008 epidemiological and economic  analyses had significant limitations. Thus, several months before DHS  announced the site selection, according to LLNL officials, the BKC  recommended that DHS conduct additional analyses—with a better  aerosol dispersion model, better input data (source term, livestock data),  and more scenarios. The BKC approached DHS in July 2008, proposing a  more comprehensive analysis, including (1) additional time to evaluate the  consequences of the accidental release scenarios, including those  identified in the EIS, to perform a more accurate risk assessment; (2)  better information such as source term and regional meteorological data  related to the scenarios; (3) information on the location and clustering of  susceptible animals in the vicinity of the sites; and (4) the use of a more  advanced aerosol dispersion model for quantitative modeling. According  to the BKC, consequence modeling for each site that was tailored to the  eight EIS scenarios would provide additional useful information but could  not be accomplished without an estimate of the likelihood that an actual  FMD virus release would lead to the infection of at least one animal at one  location—which it stated would require an assessment by a qualified risk  analysis team.
In May 2009, DHS stated that conducting such additional work would have  little value because of the limitations in the livestock data that we  previously noted. According to DHS, it held extensive discussions with the  BKC on the potential scope of additional FMD release analyses, including  evaluating the economic consequences of additional scenarios and  additional aerosol dispersion modeling. It determined that for this analysis  to have value, precise locations and numbers of livestock at the locations  for each of the six NBAF sites were needed. DHS stated that these data  were not available from the NASS and that data from local USDA field  offices were not sufficient to support further analysis. However, in July  2009, DHS also stated that it determined that the BKC analysis using the  2002 data from the NASS on a county-level basis was sufficient because  the agricultural statistics provided an accurate representation of the  agricultural information at each of the six sites.
Finally, DHS’s literature reviews included a hypothetical outbreak for the  United States as well as previous outbreaks in other countries; none were  related to the impact of an outbreak from any of the six sites. In the EIS,  DHS cited some independent studies of simulated or previous outbreaks in  other countries, including the 2001 Pirbright outbreak in the United  Kingdom, to provide estimates of the economic costs of possible U.S.  outbreaks. None of these studies were related to the EIS accident  analyses, the LLNL analyses, or the six sites. DHS stated that its literature  review was to identify upper and lower bounds of potential economic  losses, not to develop detailed estimates for specific sites.
section_title: DHS Did Not Effectively Characterize the Differences in Risk between Mainland and Island Sites
paragraphs: According to DHS, risk characterization should bring together all the  critical information from its analyses on hazard and accident scenarios,  plume modeling, and economic impact to present a comprehensive picture  of the risks an NBAF’s operation would pose. However, DHS did not  effectively integrate all the critical information from its analyses to  characterize the differences in risks between the mainland and island  sites.
The lack of integrated analyses raises questions as to whether the  evidence DHS used to support its conclusions adequately characterized  and differentiated the relative risks associated with the release of FMD  virus from the sites. In addition, the EIS and threat and risk analyses  provided little differentiation of the risks across the sites. Finally, DHS’s  analyses did not address issues of containment for large animals infected  with FMD.
section_title: DHS Did Not Effectively Integrate the Components of Its Risk Assessment
paragraphs: According to the National Academy of Sciences, an effective risk  assessment would integrate (1) scenario building for accidental and  intentional releases of infectious diseases such as FMD, (2) appropriate  methodologies for determining the extent of FMD virus dispersion and the  spread of the disease, and (3) an evaluation of site-specific relative risks  and potential impacts.
While DHS developed a set of accidental FMD virus release scenarios that  it considered representative of those likely to have the greatest impact,  and used plume modeling to determine the dispersion of FMD virus  releases under those scenarios, it did not conduct epidemiologic analyses  with the same scenarios and assumptions to predict the potential  economic impact for each site. Because DHS did not integrate its analyses,  a connection between aerosol dispersion and epidemiologic modeling  could not be established; a connection would have allowed for a more  comprehensive assessment, including economic consequences, of the  impact of an FMD virus release on the proposed sites.
At the same time, the BKC’s economic and epidemiologic analysis did not  use DHS’s accident scenarios or the results of Gaussian plume modeling  analysis. Costs associated with disease control need to be clearly linked to  the most appropriate epidemiologic models available. Using the same  scenarios—with appropriate assumptions, source term, and  meteorological data—to generate epidemiologic data and associated  economic impacts would better inform DHS about the relative merits of  the mainland and island sites with respect to the consequences of an FMD  virus outbreak, despite the assumption of its low risk. An integrated set of  analyses—scenarios, dispersion modeling, epidemiologic and economic  impact modeling—would have allowed for a more comprehensive risk  characterization and would have helped bring to light unique differences  between the mainland and Plum Island.
subsections: section_title: DHS’s Analyses Provided Little Differentiation in Risks across Sites
paragraphs: DHS’s EIS and threat and risk analyses showed very little differentiation in  the risks across the six sites. Although the EIS hazard and accident analyses  identified several factors that differed, such as the sites’ proximity to  livestock, in the final rankings they were not considered significant. DHS also  concluded that security vulnerabilities that the threat and risk analyses  identified would be the same for all sites, regardless of location. However,  DHS asserted that both the site-independent and site-specific vulnerabilities  could be mitigated by incorporating improvements. DHS therefore considered  the identified security risks at all sites to be acceptable.
The EIS ranked the sites by site-specific information, such as the  likelihood of exposure, and site-independent information, such as accident  frequency and severity. The EIS stated that the latter would be the same  for all sites because they are considered characteristic of the operations of  an NBAF at any site. Site-independent factors therefore did not  differentiate between island or mainland sites.
For the site-specific information, the EIS showed that Plum Island had  several advantages over the mainland. For example, it ranked Plum Island  low in risk with respect to the likelihood of infection, calculated with the  plume modeling results, and the likelihood of any disease spreading from  the island (see table 5). The EIS showed that Plum Island’s lack of animals  placed it at an advantage with respect to the likelihood that FMD virus  would become established after being released and spread from the site. In  contrast, all the other sites are in areas where the virus would have ample  opportunity to spread rapidly after release because of the presence of  susceptible livestock and wildlife. Further, the EIS showed that for all  sites except Plum Island, the wind could potentially transport viral  pathogens significant distances and that this pathway is not limited for  them, as it is on Plum Island.
The threat and risk analyses also identified differences in risks across  sites, but DHS concluded that they would be mitigated by security  upgrades to facility design, operational protocols, and guidelines so that  the risks would be equal across sites.
Because the different safety and security risks—no matter how extreme— that the EIS and threat and risk assessment identified were all considered  mitigated, DHS selected a site by using its original evaluation criteria (see  table 6). DHS officials told us that the Kansas site’s being near a university  would give it proximity to existing research capabilities—one of the four  evaluation criteria. DHS also said that a more detailed site-specific threat  assessment would be developed when the NBAF is designed, to mitigate  the threats identified for the Kansas location—the preferred alternative in  the EIS. Overall risk rank shows that Plum Island is generally at a low level  of risk in terms of safety while the other sites are at moderate levels;  however, in terms of security, all sites were considered to have acceptable  risks.
section_title: DHS’s Analyses Did Not Address Containment Risks for Large Animals Infected with FMD Virus
paragraphs: In earlier testimony, we found that the 2002 USDA study DHS had used to  support its conclusion that work could be done as safely on the U.S.  mainland as on Plum Island did not address in detail 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 air  filtration systems. Our review of the EIS also found that it did not address  hazards associated with large animals—a unique purpose of the NBAF.  Many of these risks, reported on in our testimony, were still not addressed  in the EIS. While the EIS identified the loss of animal control as one of the  seven accident scenarios involving an FMD virus release, it did not address  in detail the risks associated with the special containment of large animals.
As we noted in our testimony, 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 the contained areas to necropsy or incineration areas poses  additional risks. For example, one of the internal releases of FMD virus at  the PIADC happened in transporting large animal carcasses from  contained rooms through to incineration.
We also noted that transferring FMD work to an NBAF is to be  accompanied by increases in both scope and complexity over those of the  current activities at the PIADC. These increases would mean an increase  in the risk associated with work at the new facility. For example, the BSL- 3-Ag space at the new NBAF is projected to be almost twice the size of the  space currently at the PIADC and is to accommodate many more large  animals. According to PIADC officials and the EIS, requirements specify  NBAF space for 166 large cattle (up to 1,430 pounds) for both short-term  and long-term clinical trials with aerosolized FMD virus, as well as about  50 to 60 cattle for USDA’s ongoing research. This is contrasted with the  more than 100 cattle that the PIADC can handle today.
In addition, we noted an important difference between a standard BSL-3  laboratory, such as the laboratories used for work with human pathogens,  and a BSL-3-Ag laboratory. In BSL-3-Ag, the human operator has extensive  direct contact with infected animals and, consequently, the virus. Because  the virus can be carried in a person’s lungs or nostrils or on other body  parts, humans become a potential avenue by which the virus could escape  the facility. Special biosafety procedures are needed—for example, a full  shower on leaving the containment area, accompanied by expectorating to  clear the throat and blowing through the nose to clear the nasal passages.  Additionally, a 5-to-7-day quarantine is usually imposed on any person who  has been within a containment where FMD virus is present, a tacit  acknowledgment that humans can carry the disease out with them, even  after these additional procedures.
DHS has cited an FMD laboratory in Winnipeg, Canada, to support its  assertion that FMD work can be done safely on the mainland. Canada has  decided to conduct FMD work on the mainland but in a downtown  location.  Susceptible animals are not likely to be in the immediate  neighborhood. Its scope of work for FMD is also smaller than that at the  PIADC or the proposed NBAF. In the Winnipeg laboratory, the number of  animals handled is very small (two large infected animals such as cows),  whereas in the proposed NBAF, DHS plans to accommodate 166 large  cattle. The FMD work in Winnipeg is done in a Canadian level (CL-3)  facility, which is equivalent to a BSL-3Ag facility in the United States. The  proposed U.S. facility would use many more animals than the Winnipeg  facility. Consequently, using the Winnipeg facility to support its assertion  regarding the U.S. mainland NBAF facility is not valid. The U.S. mainland  sites are potentially more likely to pose a risk, given their being closer to  susceptible animal populations.
section_title: Concluding Observations
paragraphs: The analyses that DHS conducted on the potential relocation of FMD work  to the mainland have several limitations. DHS’s analyses did not effectively  characterize and differentiate the risks associated with the release of FMD  virus at the six sites. From its Gaussian plume modeling results, DHS  concluded that the mainland and Plum Island would differ little in air  concentrations from an FMD virus release. However, the simple straight- line Gaussian plume model DHS used for its accident analyses was based  on unrepresentative accident scenarios, outdated dispersion modeling  techniques, and inadequate meteorological data, and therefore it was not  appropriate for determining the extent of dispersion of an FMD virus  release. Drawing conclusions about relocating research with highly  infectious exotic animal pathogens from questionable methodology could  result in regrettable consequences. Site-specific dispersion analysis, using  proven models with appropriate meteorological data and defensible  source terms, should be conducted before scientifically defensible  conclusions can be drawn.
The economic analyses did not incorporate market response to an FMD  outbreak—which would be related to the number of livestock in the site’s  vicinity. They also did not consider the effect of establishing a  containment zone to control the effects of a national export ban on the  domestic livestock industry—which could have been used to differentiate  across NBAF sites. The analyses were constrained by limited scope and  detail. They did not incorporate worst-case outbreak scenarios.
DHS did not effectively integrate all the critical information from its  analyses to characterize differences in risks between the mainland and  island sites. The lack of integrated analyses raises questions as to whether  the evidence DHS used to support its conclusions adequately characterizes  and differentiates the relative risks associated with the release of FMD  virus from site to site. Finally, our review of the EIS also found that it did  not address hazards associated with large animals—a unique purpose of  the NBAF. We reported on these same risks in earlier testimony.
DHS asserted throughout its analyses that the technology, methods, and  safety systems associated with operating modern HCLs will mitigate any  risks and will make work with FMD virus safe on the mainland. We agree  that the value of modern containment technology has reduced the risk of  an accidental release and that the safety of HCLs has improved. However,  evidence shows that accidents continue from human error and from  operational failure in facilities. Thus, as DHS has acknowledged, the risk  of release of an agent from a modern HCL is not zero, and Plum Island  offers a unique advantage—with its water barrier and absence of  animals—over the mainland. If foreign infectious viruses are introduced  into the United States, research on these viruses must be done with the  utmost care and planning. For these reasons, work of this nature should  be conducted only where adequate analyses have shown that the  consequences of an accidental release are absolutely minimized.
Given the significant limitations in DHS’s analyses that we found, the  conclusion that FMD work can be done as safely on the mainland as on  Plum Island is not supported.
section_title: Agency Comments and Our Evaluation
paragraphs: We obtained written comments on a draft of our report from the  Department of Homeland Security, whose key concerns we discuss here.  The agency’s letter is printed in appendix II.
First, DHS noted that while we cited limitations of the DHS risk  assessment methodology, we provided no analysis that would indicate that  a different methodology would yield different results. Although the  congressional mandate did not require GAO to conduct an alternative  analysis, we went beyond the mandate to identify an alternative plume  model (RIMPUFF) that has been validated for FMD virus, as well as more  appropriate source term and meteorological data that should have been  used. We believe that using this validated model and appropriate source  term and meteorological data—and performing additional epidemiologic  and economic analyses that included worst-case scenarios, market  analyses, and the use of containment zones—would have provided more  comprehensive information for both decision makers and the public  regarding the sites’ relative differences in risks when conducting FMD  research.
Second, DHS stated that the draft report was unresponsive to the direction  of the Congress because we chose to evaluate whether FMD research can  be done as safely on the mainland as on Plum Island. In reality, we both  satisfied the mandate through our analysis of the EIS and provided  additional analysis as we agreed to with congressional requestors. This is  consistent with the way we work with the Congress in scoping all our  work. Because the PIADC has a long history of FMD work, it was agreed  that we would address the relative safety of the island and mainland sites  to put the safety issue in perspective.
Third, although DHS noted that it had stated in the NBAF EIS that the water  barrier around Plum Island provides an additional layer of protection in the  extremely unlikely event that pathogens  proposed for study at the NBAF were  accidentally released, DHS determined that the Plum Island site did not best  meet the purpose and need to locate, construct, and operate the NBAF, based  on the research; workforce; acquisition, construction, and facility operations;  and community acceptance evaluation criteria that a team of federal employees  (DHS and USDA subject matter experts) had developed. We agree with DHS  that Plum Island can provide an additional margin of safety compared to  mainland sites; however, in the DHS decision, this extra safety factor was  outweighed by nonsafety factors, such as community acceptance. DHS believes  that it can mitigate the risks of accidental or intentional releases from any of the  sites.
Fourth and finally, DHS stated that DHS and USDA have determined that  live FMD virus research can be safely studied on the mainland because  modern biocontainment technology has made the likelihood of an  accidental release of a pathogen extremely small. DHS noted that modern  biocontainment technology has eliminated the need for locating animal- disease research on an island, as was considered necessary decades ago.  DHS stated that we should not dismiss the fact that live FMD virus  research is already being performed on the mainland in other countries,  since this clearly demonstrates that such work can be conducted safely on  the mainland (with appropriate biosafety and biosecurity protocols to  minimize the risk of release). While we agree, and while we stated in our  report that modern technology has made the risk of an accidental release  of a pathogen extremely low, the risk is not zero. Accidents continue,  primarily from human error. The fact that live FMD work in countries such  as Australia and New Zealand is done mostly offshore emphasizes that  even a low risk may be considered too great where agriculture is  economically important. The challenges of maintaining a high-containment  environment in the case of FMD research are particularly difficult, given  the large number of research animals planned for the NBAF. The NBAF  EIS did not directly address those challenges. Thus, the issue is: What level  of risk is acceptable? The question is especially important when, as in this  case, an alternative is available that offers a lower level of risk than the  one that has been chosen.
Overall, once a certain low level of risk has been identified as being  acceptable for the conceptual NBAF facility, DHS appears to rank other,  nonsafety factors more highly than the further risk reduction the island  site could provide. Because safety is always a relative concept, this  prioritization of other issues over further safety is a matter of judgment  that should, for clarity, be explicitly stated and justified.
DHS and USDA also provided technical comments on and corrections to  the draft report. These comments address four areas of DHS’s risk  assessment: (1) modeling analysis, (2) meteorological and source term  data, (3) estimates of the economic impact of an FMD outbreak, and (4)  issues of containment for large animals infected with FMD. We summarize  DHS’s major comments in these four areas and our response below and  note that we have made changes to the report, as appropriate.
subsections: section_title: Modeling Analysis
paragraphs: DHS commissioned three independent subject matter experts—Johns  Hopkins University Applied Physics Laboratory, the Massachusetts  Institute of Technology Lincoln Laboratory, and Gryphon Scientific—to  review DHS’s plume modeling analysis in the draft EIS. Along with areas  where the subject matter experts agreed with the EIS authors, they also  provided some caveats based on the assumptions in the EIS and  suggestions for further analysis. DHS stated that our draft report described  limitations in the DHS risk analysis based on issues raised by these subject  matter experts and LLNL experts with regard to the EIS aerosol modeling  methodology but that we did not mention positive comments in the  independent review.
DHS also asserted that numerous models can be used to evaluate aerosol  transport of FMD virus and that no one model stands out as the premier  model to use. It cited research that compared six different FMD  atmospheric dispersion models (which did not include the MACCS2 model  DHS used or the HPAC and RIMPUFF models we cited); it concluded that  all the atmospheric dispersion models compared can be used to assess  windborne spread of FMD virus and can yield scientific advice to those  responsible for making disease control decisions in the event of an FMD  outbreak. DHS also stated that there is sufficient literature to justify the  use of the MACCS2 model (originally developed to model the dispersion of  radiological aerosols) for biological aerosol. DHS stated that several  features of Gaussian plume models make them desirable for risk  assessment. They provide, according to DHS, the ability to use yearly  averaged meteorological datasets to determine the probability that areas  away from the release site will be affected by the plume.
In fact, we did present positive comments, as appropriate. However, it is  important to note that DHS experts raised serious caveats about the use of  the MACCS2 model for FMD that are not outweighed by the positive  comments. Other experts besides DHS’s experts have raised the same  concerns about the appropriateness of using MACCS2 for biological  dispersion and safety analysis. DHS dismissed these caveats, asserting that  they would not dramatically change its conclusions, but DHS offered no  evidence to prove its assertion.
Modeling biological dispersion of dangerous pathogens is a complex  process. Using an unvalidated model for this task was inappropriate. The  MACCS2 model has a “Table of Limitations” listed in a U.S. Department of  Energy report (MACCS2 Computer Code Application Guidance for  Documented Safety Analysis, final report (Washington, D.C.: June 2004)).  Limitations include a release duration of 3 minutes to 10 hours, which is  inappropriate for a puff release; sensible energy issues that would affect  modeling when heat or other energetics are involved; and terrain  sensitivity and building wake effects that DHS addressed. The MACCS2  model also uses Pasquill stability classifications that are outdated and not  used in modern, more appropriate models. Moreover, by limiting the  dispersion to 10 km, the MACCS2 model fails to address more real-life  scenarios and worst-case scenarios that have been found important in  FMD virus dispersion.
Much better, validated, models are available and should have been used.  We believe that if DHS is going to analyze something as important as the  downwind dispersion of FMD virus after a release, it should use the best  science and validated models available. We emphasized the use of a model  that has been validated for FMD virus—such as the RIMPUFF model—as  well as the use of more appropriate source term and meteorological data.  Some models like the HPAC and RIMPUFF apply modern theory for  diffusion and turbulence factors and have been applied and validated for  the airborne spread of biologicals and, specifically, FMD. RIMPUFF,  available to all users, has been shown to provide more sophisticated and  accurate data than other simulation models. RIMPUFF is linked to a  geographic information system, so site-specific meteorological data can be  generated and integrated with geographic and demographic data for  display in a format that can be easily assimilated and transmitted  electronically.
DHS also asserted that our observation that Gaussian plume models do  not provide suitable information for modeling the effects of a specific  release is irrelevant. DHS stated that it used the Gaussian plume model as  a dispersion model to compare the six sites (thus, the relative magnitude  of downwind normalized concentration is of primary importance, not the  absolute value). We believe our statement is relevant, especially since  DHS’s independent subject matter experts made the same observations.  Modeling the effects of a specific release is critical. Limiting the  comparison of the six sites by the relative magnitude of downwind  normalized concentration does not provide the true effects of a release.  Measuring the effects of a specific release is important when attempting to  obtain site-specific relative information.
section_title: Meterological and Source Term Data
paragraphs: DHS stated that our observation on its use of meteorological data is  inaccurate. We stated that DHS’s using hourly averaged meteorological  data in the MACCS2 model, rather than wind rose meteorological data,  gave long-term averages for wind direction but cannot account for  variations in velocity. Therefore, the data were not representative of the  prevailing wind directions at the sites and did not account for the season  or time of day. DHS stated that the MACCS2 meteorological input files  contain weather data at hourly intervals for the whole year. The data take  into account the season and the time of day, the MACCS2 uses wind  direction at each hourly interval as input, and thus a typical MACCS2  dataset represents the full spectrum of wind directions over an entire year.  DHS stated that although the NBAF EIS did not provide explicit data on  the wind rose, the data from which a wind rose can be constructed are in  the MACCS2 input data set.
As we stated in our report, the wind rose data are a graphic representation  of the direction and velocity of the wind and a very important tool in  determining wind direction and, therefore, the potential dispersion of FMD  virus. Although the MACCS could provide wind direction at each hourly  interval as input, DHS did not in its modeling produce a wind rose to  determine the predominant direction and velocity of the wind. Wind rose  diagrams are straightforward to interpret. The graphic shows the primary  direction the wind travels and the relative amount of time the wind travels  from that direction. Wind rose diagrams should be applied in dispersion  modeling because they illustrate the magnitude and direction of the  predominant wind at a particular location. In addition, hourly averaged  data do not describe what dispersion would look like in a worst-case  scenario, because all meteorological conditions for longer-range transport  are averaged.
DHS also stated that we provided no evidence that the value DHS used for  the aerosol release factor was an underestimation. We stated that if a  sample of 100 ml of 1 x 10 virus could potentially be aerosolized.  We believe from our discussions with FMD experts that this value is too  low, indicating that 1 x 10-4 may be an underestimation. DHS noted that it  stated in the EIS that a spill of 1 kilogram of a liquid containing virions,  with a viscosity of water (0.01 poise), from a height of 1 meter would  result in an aerosol release factor (ARF) of approximately 8 x 10–6, which  is more than an order of magnitude lower than the 1 x 10–4 ARF value used  for spill accidents for the NBAF. DHS therefore believed that the EIS has  appropriately characterized the source term. However, we believe that the  scientific experimental data that would support the source term values  cited in the EIS are lacking. DHS used the data relating to the dispersal of  a powder—containing Bacillus anthracis—used in the 2001 anthrax  attack. The energy requirements for dispersing a powder differ in a major  way from the requirements for dispersing from a bulk liquid. According to  Danish FMD experts, in the concentration of FMD virus they produce in  their laboratory, they routinely get 10 during  their fermentation and production phases. During the centrifuging phase,  the concentration level often goes higher. Therefore, if you start with a  higher concentration of viruses in a vial and there is an accidental spill,  then the source term will be that much higher.
section_title: Estimates of Economic Impact on an FMD Outbreak
paragraphs: DHS stated that the EIS analyses used actual events and existing studies to  evaluate the economic effects of a potential FMD outbreak and that it is  likely that the direct, localized effects of an outbreak would not be limited  by the 10 km dispersion field determined by the plume modeling. For the  EIS, DHS stated, dispersion modeling was done, and there was no reason  to do epidemiologic modeling on the site selection. Because USDA’s NASS  does not release farm locations within a county, the precision of data  needed to use the plume modeling dispersion field for a localized  economic evaluation was not available. However, DHS said that the BKC  analysis using the 2002 NASS data on a county-level basis was sufficient,  because the agricultural statistics accurately represented the agricultural  information at each of the six sites. The NBAF EIS table D.2-l shows direct  economic costs less than 4 percent of the total economic costs of a  potential FMD virus release for all sites. However, DHS did not directly  address our point concerning the need for additional economic analyses  involving market response and containment zones; instead, it stated that  the EIS analyses would not include a market analysis and the  establishment of containment zones to lessen the impact of an export ban  for all six sites. DHS stated that OIE’s determination regarding a country’s  FMD status is based on how the country’s authorities respond to the  incursion rather than to where the outbreak occurs. DHS also stated that  its literature review—intended to identify upper and lower bounds of  potential economic losses and not to develop detailed estimates for  specific sites—had included one study that demonstrated the local impact  of an FMD outbreak in southwestern Kansas.
We believe that the use of worst-case scenarios and available, if limited,  livestock data for additional epidemiologic and economic analyses— including outbreaks of longer durations—would further differentiate the  sites, including showing unique differences between the mainland sites  and Plum Island. Because the United States has not had an FMD outbreak  since 1929, much is uncertain about the potential consequences of a  release. For example, it is not clear in which species, or how, wildlife can  spread and act as a reservoir for the virus, despite the perceived low risk  of its occurring. In addition, each site has its own level of susceptible  livestock and wildlife in the vicinity, but DHS did not model the spread of  FMD after an initial infection. As we stated in the report, studies have  shown that the virus can travel distances far greater than 10 km from a  release. Furthermore, while an export ban in the event of a confirmed  FMD infection would result in an immediate foreign ban on the export of  animal products, the consequences of that ban—from both a foreign and a  domestic standpoint—would be affected by the ease of establishing a  containment zone, as well as by the market response to the outbreak.  Thus, we believe it imperative that decision makers be provided with  analyses sufficiently detailed to show the relative differences in risk  among sites—regardless of the confidence in HCLs to reduce those risks— before a site decision is made. Lacking these additional epidemiologic and  economic analyses, we think DHS’s efforts to evaluate the economic  impact of an FMD outbreak did not provide sufficient information on the  relative differences in risks across sites, particularly with respect to  potential consequences.
Finally, DHS appears to have misunderstood our meaning of the term  integration, discussing its overall risk assessment methodology and  conclusions rather than addressing DHS’s lack of integration of the  accident analyses in the EIS with the BKC epidemiologic and economic  analyses—our main point. While DHS developed a set of accidental FMD  virus release scenarios that it considered to represent those likely to have  the greatest impact, and used plume modeling to determine the dispersion  of FMD virus releases under those scenarios, it did not conduct  epidemiologic analyses with the same scenarios and assumptions to  predict the potential economic impact for each site; had DHS done so, it  would have produced a more comprehensive picture of the relative  differences in impacts of an FMD virus release across sites and, also, a  better comparison of the mainland sites to Plum Island.
subsections: section_title: Issues of Containment for Large Animals Infected with FMD
paragraphs: DHS stated that live FMD virus research is already being performed on the  mainland in other countries and that five BSL-4 facilities currently operate  in the United States in populated areas. DHS noted that no public  exposure has ever resulted from research at a BSL-4 laboratory in the  United States. DHS asserted that modern biocontainment technology has  eliminated the need for locating animal-disease research on an island, as  was done decades ago. DHS also stated that state-of-the-art operating  procedures and biocontainment features minimize the potential for  laboratory-acquired infections and accidental releases. In addition, DHS  stated that the hazards of working with large livestock are not site- specific. It has been shown, and is demonstrated daily, that at the PIADC,  with proper training, scientists and animal handlers work safely with large  animals.
DHS is not addressing our main point about the significant increase in  potential risks because of the larger scale of work with infected animals in  BSL-3 Ag facilities than that conducted in BSL-4 facilities. The BSL-4  laboratory work that DHS refers to is work with human pathogens. Our  comments relate to safety issues concerning work with FMD under BSL -3  Ag, where the containment level is lower than in BSL-4 and human  operators can have direct contact with infected animals.
The more direct contact between FMD-infected animals and humans is  possible because FMD virus is not a human pathogen. In BSL-3 Ag  laboratories, direct contact is also more extensive between human  operators—a potential avenue for escape of the virus—and FMD-infected  animals. In addition, the amount of virus animals excrete will be  significantly higher in BSL-3 Ag laboratories because the animals are  larger; thus, the potential for exposure is greater. While it is true that with  proper training, scientists and animal handlers could work safely with  large animals, DHS’s comments do not address the issues we raised about  the lack of analyses in the EIS concerning the risks associated with the  containment of large animals infected with FMD.
We recognize that the PIADC’s working practices have been shown to be  generally effective in preventing the release of virus. Our point here,  however, is that although the hazards of handling large livestock may not  be site-specific, the potential consequences are—in the event of a release  of the virus. We believe the importance of the island location cannot be  evaluated as a separate factor, since the United States has had no  comparable mainland site. Comparison with the Pirbright facility in the  United Kingdom, where FMD outbreaks occurred from an accidental  release of FMD virus, emphasizes the safety value of the island location.
We are sending copies of this report to the Secretary of Homeland Security  and the Secretary of Agriculture. We will also make copies available to  others on request. In addition, the report will be available at no charge on  the GAO Web site at www.gao.gov.
If you or your staff have any questions about this report, please contact me  at (202) 512-2700 or kingsburyn@gao.gov or contact Sushil K. Sharma,  DrPH, Ph.D., at (202) 512-3460 or sharmas@gao.gov. Contact points for our  Office of Congressional Relations and Office of Public Affairs may be  found on the last page of this report. GAO staff who made contributions to  this report are listed in Appendix III.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: The Consolidated Security, Disaster Assistance, and Continuing  Appropriations Act of 2009 required us to review the U.S. Department of  Homeland Security’s (DHS) risk assessment of whether foot-and-mouth  disease (FMD) work can be done safely on the U.S. mainland. To ensure  that DHS has properly considered the risks associated with a potential  release of FMD virus from a high-containment laboratory (HCL) on a  mainland site compared to one on an island, we assessed, as mandated,  the evidence DHS used to conclude that work with FMD can be conducted  as safely on the U.S. mainland as on Plum Island.
To fulfill this mandate, we reviewed agencies’ documents, including the  draft and final environmental impact statements (EIS), threat and risk  assessment, and Lawrence Livermore National Laboratory (LLNL) and  Biodefense Knowledge Center (BKC) studies; relevant legislation and  regulations governing DHS and the U.S. Department of Agriculture  (USDA); and literature on FMD and HCLs.
We interviewed officials from the DHS Office of Science and Technology  and the USDA Agriculture Research Service. We visited the Plum Island  Animal Disease Center (PIADC), where we examined animal containment  areas and unique aspects of the island, and we talked with DHS and USDA  officials who oversee and operate the facility. We talked with the  contractors who performed the dispersion modeling and officials of DHS’s  Biodefense Knowledge Center at LLNL, who analyzed the potential impact  of an accidental release of FMD virus from each of six proposed sites. We  also talked with experts on animal diseases and HCLs dealing with animal,  zoonotic, and human pathogens. We consulted with large animal  veterinarians and agriculture economists.
In addition to talking with experts on plume modeling, we talked with  officials of the National Atmospheric Release Advisory Center,  Interagency Modeling and Atmospheric Assessment Center, at LLNL;  Defense Threat Reduction Agency; National Ground Intelligence Center of  the U.S. Army; Risø National Laboratory for Sustainable Energy at the  Technical University of Denmark; and Meteorological Model Systems at  the Danish Meteorological Institute.
We visited other facilities that conduct FMD work, including 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 Institute for Animal Health  Pirbright facility. We also talked with officials of the Australian Animal  Health Laboratory in Geelong and Canada’s National Centre for Foreign  Animal Disease in Winnipeg. In addition, we talked with officials of the  World Organisation for Animal Health in France.
We conducted our work from October 2008 through May 2009 in  accordance with generally accepted government auditing standards. Those  standards require that we plan and perform an audit to obtain sufficient,  appropriate evidence to provide a reasonable basis for our findings and  conclusions, based on our audit objectives. We believe that the evidence  we obtained provides a reasonable basis for our findings and conclusions,  based on our audit objectives.
section_title: Appendix II: Comments from the Department of Homeland Security
section_title: Appendix III: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
paragraphs: Nancy Kingsbury, Ph.D., (202) 512-2700, or kingsburyn@gao.gov.
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Sushil Sharma, Dr.PH, Ph.D.,  (Assistant Director); Hazel Bailey; Amy Bowser; Timothy Carr; Jason  Fong; Jack Melling, Ph.D.; Alan Jeff Mohr, Ph.D.; Susan Offutt, Ph.D.;  Timothy Persons, Ph.D.; Penny Pickett, Ph.D.; Elaine Vaurio; and Neal  Westgerdes, DVM, made key contributions to this report.