This is the accessible text file for GAO report number GAO-09-747 
entitled 'Biological Research: Observations on DHS's Analyses 
Concerning Whether FMD Research Can Be Done as Safely on the Mainland 
as on Plum Island' which was released on July 30, 2009. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as part 
of a longer term project to improve GAO products' accessibility. Every 
attempt has been made to maintain the structural and data integrity of 
the original printed product. Accessibility features, such as text 
descriptions of tables, consecutively numbered footnotes placed at the 
end of the file, and the text of agency comment letters, are provided 
but may not exactly duplicate the presentation or format of the printed 
version. The portable document format (PDF) file is an exact electronic 
replica of the printed version. We welcome your feedback. Please E-mail 
your comments regarding the contents or accessibility features of this 
document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

[The electronic version of this report was reposted July 30, 2009, to 
correct errors in table 6.] 

Report to Congressional Committees: 

United States Government Accountability Office: 
GAO: 

July 2009: 

Biological Research: 

Observations on DHS's Analyses Concerning Whether FMD Research Can Be 
Done as Safely on the Mainland as on Plum Island: 

GAO-09-747: 

Contents: 

Letter: 

Background: 

DHS Used Evidence from Four Types of Analysis: 

Our Assessment of DHS's Analyses of Plume Modeling, Economic Impact, 
and Security Issues: 

DHS's Estimate of Economic Impact Was Based on Limited Analysis: 

DHS Did Not Effectively Characterize the Differences in Risk between 
Mainland and Island Sites: 

DHS Did Not Effectively Integrate the Components of Its Risk 
Assessment: 

Concluding Observations: 

Agency Comments and Our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Comments from the Department of Homeland Security: 

Appendix III: GAO Contacts and Staff Acknowledgments: 

Tables: 

Table 1: DHS's Accident Scenarios and Potential Consequences for an 
NBAF Site: 

Table 2: Average Estimated Air Concentration for a Spill Scenario at 
Six Sites: 

Table 3: Outbreak Scenarios in the BKC Analysis: 

Table 4: Livestock within 10 km of the Six Sites: 

Table 5: DHS's Risk Rankings for Mitigated Accident Analyses for 
Potential Exposure at the Six Sites: 

Table 6: DHS's Site Rankings, Risk Ratings, and Evaluation Criteria: 

Figures: 

Figure 1: The Plume Modeling Process: 

Figure 2: Results from DHS's Analyses of NBAF Safety, Economic Impact, 
and Security: 

Figure 3: Far Field Manhattan, Kansas, Distribution of Virions: 

Figure 4: Average Estimated Economic Impact of FMD Virus Randomly 
Introduced in Counties around the Six Sites: 

Abbreviations: 

BKC: Biodefense Knowledge Center: 

BSL: biosafety level: 

BSL-3-Ag: biosafety level 3 agricultural: 

DHS: U.S. Department of Homeland Security: 

EIS: environmental impact statement: 

EPA: Environmental Protection Agency: 

FMD: foot-and-mouth disease: 

HCL: high-containment laboratory: 

HPAC: Hazard Prediction and Assessment Capability: 

HSPD-9: Homeland Security Presidential Directive 9: 

LLNL: Lawrence Livermore National Laboratory: 

MIT: Massachusetts Institute of Technology: 

MM5: Mesoscale Model version 5: 

NASS: National Agricultural Statistics Service: 

NBAF: National Bio-and Agro-Defense Facility: 

NCAR: National Center for Atmospheric Research: 

NOAA: National Oceanic and Atmospheric Administration: 

OIE: World Organisation for Animal Health: 

PIADC: Plum Island Animal Disease Center: 

USDA: U.S. Department of Agriculture: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

July 30, 2009: 

Congressional Committees: 

Foot-and-mouth disease (FMD) is the most highly infectious animal 
disease known: nearly 100 percent of exposed animals become infected 
with it.[Footnote 1] 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.[Footnote 2] 
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.[Footnote 3] 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.[Footnote 4] 

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.[Footnote 5] When fully operational, the NBAF 
is meant to replace the PIADC.[Footnote 6] 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.[Footnote 7] 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).[Footnote 8] 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. 

Background: 

The Foot-and-Mouth Disease Virus: 

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.[Footnote 9] 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. 

FMD Outbreaks: 

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. 
[Footnote 10] In all, eight separate outbreaks occurred over 2 months. 

The Economic Consequences of an Outbreak: 

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. 

Agriculture Biosafety Levels: Animals of Agricultural Significance: 

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). 

The Plum Island Animal Disease Center: 

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.[Footnote 11] 

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.[Footnote 12] 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. 

DHS's Reasons for Considering Relocation: 

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. 

Legislation Allowing FMD Work on the Mainland: 

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.[Footnote 13] 
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. 
[Footnote 14] The permit is limited to one facility. 

DHS's Site Selection Process for the NBAF: 

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.[Footnote 15] 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.[Footnote 16] 

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;[Footnote 17] 

* 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;[Footnote 18] 

* the economic effects of a release or a perceived release on the 
local, state, and national livestock industry.[Footnote 19] 

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. 

Plume Modeling: 

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. 

Figure 1: The Plume Modeling Process: 

[Refer to PDF for image: illustration] 

Meteorological inputs: 
* Observations; 
* Forecasts. 

Flow to: 
Aerosol dispersion model; 

Flow to: 
Concentrations downwind; 

Flow to: 
Deposition (vapor, liquid, and solids); and: 
Health and environmental effects. 

Concentrations downwind; also flow to: 
Health and environmental effects. 

Source term data (where, when, how much): flows to: 
Aerosol dispersion model. 

Source: GAO. 

[End of figure] 

DHS Used Evidence from Four Types of Analysis: 

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. 

Hazard and Accident Analysis Identified Seven Scenarios for FMD Virus 
Release: 

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 
equipment failures, 

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.[Footnote 20] 

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.[Footnote 21] The 
seven of the eight scenarios that could result in an accidental release 
of FMD virus are shown in table 1.[Footnote 22] 

Table 1: DHS's Accident Scenarios and Potential Consequences for an 
NBAF Site: 

Scenario: Spill or uncontrolled release of aerosolized pathogens 
(including known and unknown releases); 
Consequence: Loss of biocontainment and area contamination but no 
environmental contamination. 

Scenario: Loss of animal or insect control; 
Consequence: Environmental contamination (includes the potential for 
loss of biocontainment of an infected animal). 

Scenario: Improper sterilization and disinfection of solid or liquid 
waste; 
Consequence: Environmental contamination caused by release of 
significant viable pathogens into commercial or solid or liquid waste 
handling systems. 

Scenario: Large room or facility fire; 
Consequence: Loss of facility structure and potential environmental 
contamination caused by the release of one or more viral pathogens. 

Scenario: Overpressure event from deflagration (the combustion of 
flammable chemicals or natural gas); 
Consequence: Loss of facility's biocontainment, resulting in loss of 
pathogens in aerosol form. 

Scenario: Seismic or high wind event (such as earthquake or tornado); 
Consequence: Environmental contamination from a large, multilaboratory 
spill as the result of a seismic event or structural damage from high 
winds; potential effect on entire facility structure. 

Scenario: Aircraft crash into NBAF's external gasoline or fuel oil 
storage with explosion or fire; 
Consequence: Loss of facility's biocontainment followed by release of 
viral pathogens into the environment. 

Source: DHS, National Bio-and Agro-Defense Facility: Final 
Environmental Impact Statement (Washington, D.C.: December 2008). 

[End of table] 

DHS's Plume Modeling Determined the Extent of FMD Virus Dispersion: 

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.[Footnote 23] 

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 × 108 
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. 

Table 2: Average Estimated Air Concentration for a Spill Scenario at 
Six Sites: 

Meters from spill: 50; 
Georgia: 93,400; 
North Carolina: 81,100; 
Kansas: 161,000; 
Mississippi: 161,000; 
Texas: 161,000; 
New York-Plum Island: 161,000. 

Meters from spill: 200; 
Georgia: 9,000; 
North Carolina: 7,800; 
Kansas: 15,700; 
Mississippi: 15,700; 
Texas: 15,700; 
New York-Plum Island: 15,700. 

Meters from spill: 600; 
Georgia: 1,660; 
North Carolina: 1,440; 
Kansas: 2,910; 
Mississippi: 2,910; 
Texas: 2,910; 
New York-Plum Island: 2,910. 

Meters from spill: 1,000; 
Georgia: 769; 
North Carolina: 666; 
Kansas: 1,350; 
Mississippi: 1,350; 
Texas: 1,350; 
New York-Plum Island: 1,350. 

Meters from spill: 6,000; 
Georgia: 14; 
North Carolina: 15; 
Kansas: 25; 
Mississippi: 91; 
Texas: 40; 
New York-Plum Island: 91. 

Meters from spill: 10,000; 
Georgia: 7; 
North Carolina: 5; 
Kansas: 12; 
Mississippi: 16; 
Texas: 14; 
New York-Plum Island: 30. 

Source: GAO conversion of data in table E.4.4.3 "Unmitigated Site-
Specific Air Concentration Estimates from a Spill Release of Aerosol 
Pathogen," in DHS, National Bio-and Agro-Defense Facility: Final 
Environmental Impact Statement (Washington, D.C.: December 2008), vol. 
II, p. E-156. 

Note: Concentration in a cubic meter of air without any attempt to 
mitigate. Calculation of the normalized concentration is independent of 
the parameter being modeled--in this case, a virion. It is only a 
function of the atmospheric parameters (wind speed, stability, rain) 
and the surrounding location (topography, buildings). 

[End of table] 

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. 

The BKC Conducted Economic Analyses to Determine the Impact of a 
Release: 

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.[Footnote 24] 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.[Footnote 25] 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.[Footnote 26] 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. 

Table 3: Outbreak Scenarios in the BKC Analysis: 

No. of scenarios: 1; 
Category: Single, random release in NBAF county livestock premises; 
Description: Outbreak from single, random introduction of FMD virus 
into randomly selected livestock premises in county proposing to host 
NBAF (sales yards excluded but allowed to spread FMD). 

No. of scenarios: 4; 
Category: Potential impact by type of animal species infected; 
Description: FMD virus randomly occurring in cattle, swine, sheep, and 
goat premises; after introduction, FMD virus allowed to spread to all 
other types of premises (possibly represents fomite release[A]). 

No. of scenarios: 2; 
Category: Potential impact of aerosol release in county of NBAF; site 
and surrounding counties; 
Description: 
1. FMD virus introduction limited to one farm; 
2. Five farms initially infected (may correspond to larger aerosol 
release); relative susceptibility of various animal species at risk or 
animals housed indoors not considered; 
3. Weighting factor used to ensure that farm where initial infection 
occurs is proportional to number of animals on each farm because farms 
with higher animal density would be more likely to become infected; 
analysis assumed that aerosol release would infect all species equally. 

Source: GAO analysis of BKC study. 

Note: The national dataset available for this analysis was the 2002 
National Agricultural Statistical Survey, which does not include exact 
herd locations in a given county. For each of the six locations, seven 
scenarios were evaluated (42 total scenarios) and 400 epidemic 
realizations were simulated per scenario (16,800 epidemics). 

[A] A fomite is an inanimate object or substance that has been in 
contact with an infected animal, retains some of the infectious agent, 
and can serve as a source of infection. Fomites include contaminated 
materials, equipment, soil, and vegetation. 

[End of table] 

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. 

DHS Conducted a Threat and Risk Assessment to Determine Security Risks: 

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.[Footnote 27] They included crimes against people 
and property and threats from compromised or disgruntled employees. 
[Footnote 28] 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. 
[Footnote 29] Figure 2 summarizes DHS's conclusions from its analyses. 

Figure 2: Results from DHS's Analyses of NBAF Safety, Economic Impact, 
and Security: 

[Refer to PDF for image: illustration] 

EIS hazard and accident analysis: 
Gaussian plume modeling/coupled with livestock data (Dec. 2008): 
Little differentiation across sites in safety risks: 
* Seven accidental FMD virus release scenarios; 
* Overall rank: Plum Island, N.Y., low risk; others moderate risk; 
* Each site—except Plum Island—provides ample opportunity for FMD virus 
to spread because of local livestock densities. 

EIS literature review and BKC epidemiological and economic analyses 
(May 2008): 
Export trade ban highest economic impact, regardless of location: 
* Seven FMD virus outbreak scenarios; 
* Total outbreak cost: Lower Plum Island, $2.8 billion; highest, Kans. 
$4.2 billion; Aerosol release impact: low N.Y.; high Kans.
* Infected animals: largest Kans. and N.C. - fewest N.Y. 
* Infected herds: N.Y. and Tex. smallest; Kans. larger. 

Threat and risk assessment (Sept. 2008): 
Little differentiation across sites in security risks: 
* Acceptable risks for all sites; 
* Identified risk can be reduced by mitigation strategy. 

Source: GAO analysis of DHS data. 

Note: The EIS accident and BKC outbreak scenarios are described in 
greater detail in this report. 

[End of figure] 

Our Assessment of DHS's Analyses of Plume Modeling, Economic Impact, 
and Security Issues: 

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. 

Limitations in Plume Modeling: 

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. 

The Gaussian Plume Model Is Not Appropriate for Determining FMD Virus 
Dispersion: 

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.[Footnote 30] 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.[Footnote 31] 
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.[Footnote 32] 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. 

Assumptions about Meteorological and Source Term Data May Have 
Introduced Errors That Influenced the Modeling Results: 

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). 

Meteorological Data: 

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.[Footnote 33] 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.[Footnote 34] 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. 

Source Term Data: 

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: 

where: 

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 accident, 

3. ARF (or aerosol release factor) is the fraction of MAR × DR that is 
aerosolized, 

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 × 108 (100,000,000) viable 
virions could be present in a single ml of culture media. 

The EIS, however, did not provide evidence for how DHS reached its 
assumptions on the quantity of biological material and the number of 
viable virions in a singe ml of culture media. According to the Danish 
experts, the value of 1 x 108 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 
106 to 1010 viruses per ml. Viruses, after production but before being 
used or stored, are typically concentrated at values as high as 1012 ml 
or 1013 ml, depending on the virus size and other factors. Danish 
scientists who work with FMD virus told us that their production 
concentrations are typically 109 to 1010 virion per ml. Using the value 
of 108 viruses per ml and a quantity whose maximum is 100 ml raises 
questions concerning original assumptions. Order of magnitude 
underestimations of downwind hazards could arise by applying 
concentrations that do not represent actual values. Research has found 
that FMD virus can spread to greater distances downwind from the 
release.[Footnote 35] 

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. 

Fourth, when Department of Energy equations were used to support the 
value of 1 x 10-4, the bulk density of gelatin was used, which was 
inappropriate for viral study cultures. If a sample of 100 ml of 1 x 
108 viruses is dropped, and an aerosol release factor of 1 x 10-4 is 
used, only 1 x 106 viruses could potentially be aerosolized. This value 
is too low, indicating that 1 x 10-4 may be an underestimation. 

Particle Size: 

Particle size is a very important model input, dictating the extent of 
dispersion and biological aerosol stability. DHS's modelers determined 
particle size from a literature search for a representative pathogen 
other than FMD. Since the viruses were found to exist in the sizes that 
could be modeled for atmospheric transport, a representative size of 1 
micron was assumed to simulate the downwind transport. 

Particles can be removed from the plume and deposited on the ground 
(called dry deposition) or in rain (in wet deposition). The values for 
particle settling in the model were estimated to be in the range of 0.1 
to 1 centimeters per second. However, for outdoor dispersion modeling, 
the rate of settling would be essentially 0 because of the horizontal 
and vertical components of the wind. Particles of 1 micron to 5 microns 
are essentially vapors and their settling rates are negligible. In 
addition, in its review of aerosol calculations from the draft EIS, the 
Johns Hopkins University's Applied Physics Laboratory found that the 
calculations of removal by dry deposition may have been overestimates. 
It found that the settling velocities of 0.1 to 1 cm/sec correspond to 
particles with diameters larger than 1 micron. Because of the 
fundamental sizes of the viruses considered in these calculations, 
there may be respirable, virus-containing particles that settle at 
significantly slower rates than those assumed. Since this would lead to 
the suspension of particles for longer times, the distance of plume 
dispersion away from the source may have been underestimated. The 
Applied Physics Laboratory also noted that biological particles may be 
incorporated into cloud droplets and transported with the cloud. It 
cited studies that suggest that biological aerosol would be suitable 
cloud condensation nuclei.[Footnote 36] 

Decay Rate: 

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. 

DHS Did Not Model the Spread of FMD after Infection: 

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. 

Figure 3: Far Field Manhattan, Kansas, Distribution of Virions: 

[Refer to PDF for image: satellite image] 

Image legend includes the following map depictions: 

Radial distance (km): 2.0; 
Ar Concentration (s/m3): 1.9 x 10-4; 
Gorund concentration (m3): 1.4 x 10-7. 

Radial distance (km): 4.0; 
Ar Concentration (s/m3): 5.2 x 10-4; 
Gorund concentration (m3): 3.7 x 10-8. 

Radial distance (km): 6.0; 
Ar Concentration (s/m3): 2.5 x 10-5; 
Gorund concentration (m3): 1.7 x 10-8. 

Radial distance (km): 8.0; 
Ar Concentration (s/m3): 1.4 x 10-5. 
Gorund concentration (m3): 1.1 x 10-8. 

Radial distance (km): 10.0; 
Ar Concentration (s/m3): 1.2 x 10-5; 
Gorund concentration (m3): 8.2 x 10-9. 

Source: Figure 3.14.4.2-2 Far Field Distribution of Viral Pathogens 
Based on Time-Integrated Atmospheric Transport from the December 2008 
National Bio- and Agro-Defense Facility Final Environmental Impact 
Statement (Vol. I, ch. 3.14 Health and Safety, page 3-460); reprinted 
with permission from the U.S. Department of Homeland Security. 

[End of figure] 

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. 

Table 4: Livestock within 10 km of the Six Sites: 

Site: New York-Plum Island; 
No. of livestock per sq km: 0; 
Type: Very limited wildlife. 

Site: North Carolina; 
No. of livestock per sq km: 0-30; 
Type: Mostly cattle. 

Site: Mississippi; 
No. of livestock per sq km: 10-20; 
Type: Mostly cattle. 

Site: Texas; 
No. of livestock per sq km: 10-30; 
Type: Mostly cattle. 

Site: Georgia; 
No. of livestock per sq km: 20-30; 
Type: Mostly cattle. 

Site: Kansas; 
No. of livestock per sq km: 20-50; 
Type: Mostly cattle. 

Source: DHS, National Bio-and Agro-Defense Facility: Final 
Environmental Impact Statement (Washington, D.C.: December 2008). 

[End of table] 

DHS's Estimate of Economic Impact Was Based on Limited Analysis: 

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.[Footnote 37] 

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.[Footnote 38] 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 channel[Footnote 39]s. 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.[Footnote 40] 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.[Footnote 41] 

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. 

Figure 4: Average Estimated Economic Impact of FMD Virus Randomly 
Introduced in Counties around the Six Sites (Dollars in millions): 

[Refer to PDF for image: multiple vertical bar graph] 

Foreign trade lost: 	
Proposed NBAF site, Georgia: $3,100; 
Proposed NBAF site, Kansas: $3,100; 
Proposed NBAF site, Mississippi: $3,100; 
Proposed NBAF site, North Carolina: $3,000; 
Proposed NBAF site, New York: $2,700; 
Proposed NBAF site, Texas: $3,100. 

Indirect cost: industry disruption; 
Proposed NBAF site, Georgia: $154; 
Proposed NBAF site, Kansas: $1,001; 
Proposed NBAF site, Mississippi: $216; 
Proposed NBAF site, North Carolina: $430; 
Proposed NBAF site, New York: $31; 
Proposed NBAF site, Texas: $940. 

Direct cost to government: 
Proposed NBAF site, Georgia: $94; 
Proposed NBAF site, Kansas: $97; 
Proposed NBAF site, Mississippi: $94; 
Proposed NBAF site, North Carolina: $95; 
Proposed NBAF site, New York: $93; 
Proposed NBAF site, Texas: $93. 

Source: Homeland Security Biodefense Knowledge Center, Rapid Response, 
May 29, 2008. 

[End of figure] 

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.[Footnote 
42] 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. 

DHS Did Not Effectively Characterize the Differences in Risk between 
Mainland and Island Sites: 

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. 

DHS Did Not Effectively Integrate the Components of Its Risk 
Assessment: 

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. 

DHS's Analyses Provided Little Differentiation in Risks across Sites: 

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.[Footnote 43] 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. 

Table 5: DHS's Risk Rankings for Mitigated Accident Analyses for 
Potential Exposure at the Six Sites: 

Risk: Low; Likelihood of receptor infection: Increases with 
concentration--i.e., the dose is equal to or greater than the minimum 
infection dose for FMD virus (= 10 virions); 
Georgia: [Empty]; 
Kansas: [Empty]; 
Mississippi: [Empty]; 
North Carolina: [Empty]; 
Texas: [Empty]; 
New York-Plum Island: [Check]. 

Risk: Moderate; 
Likelihood of receptor infection: Approaches zero-- i.e., the dose is 
less than the minimum infection dose; 
Georgia: [Check]; 
Kansas: [Check]; 
Mississippi: [Check]; 
North Carolina: [Check]; 
Texas: [Check]; 
New York-Plum Island: [Empty]. 

Risk: High; 
Likelihood of receptor infection: Approaches certainty-- i.e., the dose 
is more than 10 times the minimum infection dose; 
Georgia: [Empty]; 
Kansas: [Empty]; 
Mississippi: [Empty]; 
North Carolina: [Empty]; 
Texas: [Empty]; 
New York-Plum Island: [Empty]. 

Source: DHS, National Bio-and Agro-Defense Facility: Final 
Environmental Impact Statement (Washington, D.C.: December 2008). 

Note: This ranking was based on calculations using plume modeling 
results relative to the minimum infectious dose and a cow's breathing 
rate. The interpretation of the site-specific risk ranks includes 
mitigated and unmitigated site-independent accident frequencies, which 
according to the EIS do not differ from one site to another. 

[End of table] 

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. 

Table 6: DHS's Site Rankings, Risk Ratings, and Evaluation Criteria: 

Site: Kansas; 
Risk ratings: 
Rank: 1; 
Safety: Moderate; 
Security: Acceptable; 
Meets four evaluation criteria: 
Near workforce?: Partly; 
Near research?: Yes; 
Available acquisition, construction, operations?: Yes; 
Community acceptance?: Yes. 

Site: Texas; 
Risk ratings: Rank: 2; 
Risk ratings: Safety: Moderate; 
Risk ratings: Security: Acceptable; 
Meets four evaluation criteria: 
Near workforce?: Yes; 
Near research?: Partly; 
Available acquisition, construction, operations?: Partly; 
Community acceptance?: Yes. 

Site: Georgia; 
Risk ratings: 
Rank: 3; 
Safety: Moderate; 
Security: Acceptable; 
Meets four evaluation criteria: 
Near workforce?: Partly; 
Near research?: Partly; 
Available acquisition, construction, operations?: Partly; 
Community acceptance?: Partly. 

Site: Mississippi; 
Risk ratings: 
Rank: 4; 
Safety: Moderate; 
Security: Acceptable; 
Meets four evaluation criteria: 
Near workforce?: No; 
Near research?: No; 
Available acquisition, construction, operations?: Yes; 
Community acceptance?: Yes. 

Site: North Carolina; 
Risk ratings: 
Rank: 4; 
Safety: Moderate; 
Security: Acceptable; 
Meets four evaluation criteria: 
Near workforce?: Yes; 
Near research?: Yes; 
Available acquisition, construction, operations?: No; 
Community acceptance?: No. 

Site: New York-Plum Island; 
Risk ratings: 
Rank: 4; 
Safety: Low; 
Security: Acceptable; 
Meets four evaluation criteria: 
Near workforce?: Partly; 
Near research?: Partly; 
Available acquisition, construction, operations?: Partly; 
Community acceptance?: No. 

Source: GAO analysis of DHS's final EIS and related information. 

[End of table] 

DHS's Analyses Did Not Address Containment Risks for Large Animals 
Infected with FMD Virus: 

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. 

Concluding Observations: 

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. 

Agency Comments and Our Evaluation: 

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. 

Modeling Analysis: 

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. 

Meterological and Source Term Data: 

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 108 viruses is dropped, and an aerosol 
release factor of 1 x 10-4 is used, only 1 x 106 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 109 and often get as 
high as 1010 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. 

Estimates of Economic Impact on an FMD Outbreak: 

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. 

Issues of Containment for Large Animals Infected with FMD: 

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 [hyperlink, 
http://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. 

Signed by: 

Nancy Kingsbury, Ph.D. 
Managing Director, Applied Research and Methods: 

List of Committees: 

The Honorable Henry A. Waxman:
Chairman:
The Honorable Joe Barton:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives: 

The Honorable Robert C. Byrd:
Chairman:
The Honorable George Voinovich:
Ranking Member:
Subcommittee on Homeland Security:
Committee on Appropriations:
United States Senate: 

The Honorable David E. Price:
Chairman:
The Honorable Harold Rogers:
Ranking Member:
Subcommittee on Homeland Security:
Committee on Appropriations:
House of Representatives: 

The Honorable Bart Stupak:
Chairman:
The Honorable Greg Walden:
Ranking Member:
Subcommittee on Oversight and Investigations:
Committee on Energy and Commerce:
House of Representatives: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

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. 

[End of section] 

Appendix II: Comments from the Department of Homeland Security: 

U.S. Department of Homeland Security: 
Deputy Under Secretary for Science and Technology: 
Washington, DC 20528: 
[hyperlink, http://www.dhs.gov] 

July 7, 2009: 

Nancy Kingsbury, Ph.D. 
Managing Director, Applied Research and Methods: 
U.S. Government Accountability Office: 
441 G Street, NW: 
Washington, D.C. 20548: 

Dear Dr. Kingsbury: 

Thank you for the opportunity to review and comment on the draft GAO-09-
747 report, "Biological Research: Observations on DHS's Analyses 
Concerning Whether FMD Research Can Be Done as Safely on the Mainland 
as on Plum Island." 

GAO prepared the draft report in response to the Consolidated Security, 
Disaster Assistance, and Continuing Appropriations Act of 2009 (P.L. 
110-329) which directed GAO to review the Department's "risk assessment 
of whether foot-and-mouth disease work can be done safely on the United 
States mainland." DHS conducted this risk assessment as part of the 
National Bio and Agro-defense Facility (NBAF) Environmental Impact 
Statement (EIS). 

The Department of Homeland Security (DHS) notes that although the draft 
GAO report cites "limitations" of the DHS risk assessment methodology, 
it provides no analysis that would indicate that a different 
methodology would yield different results, nor does the draft report 
offer any recommendations. 

DHS also notes that the draft GAO report is unresponsive to the 
direction of the Congress. Instead of evaluating if foot-and-mouth 
disease (FMD) research "can be done safely on the mainland" per 
Congressional direction in P.L. 110-329. GAO instead chose to evaluate 
whether FMD research can "be done m, safely on the mainland as on Plum 
Island." DHS stated in the NBAF EIS that the water barrier around Plum 
Island would provide an additional layer of protection in the extremely 
unlikely event of an accidental release of any pathogen proposed for 
study at NBAF. DHS determined, however, that the Plum Island site did 
not best meet the purpose and need to site, construct, and operate the 
NBAF based on the Research. Workforce, Acquisition/Construction/ 
Operations, and Community Acceptance site evaluation criteria developed 
by a team of Federal employees (DHS and the U.S. Department of 
Agriculture (USDA) subject matter experts). There is also strong 
political opposition at Federal, state, and local levels to having BSI.-
4 research performed on Plum Island. 

DHS and USDA have determined that live FMD virus research can be safely 
studied on the mainland, and fully support the decision to construct 
and operate the NBAF at the Manhattan, Kansas, site. While the study of 
contagious diseases anywhere is not without risk, modem biocontainment 
technology has made the likelihood of an accidental release of a 
pathogen extremely low. Modern biocontainment technology has eliminated 
the need for locating animal-disease research on an island as was done 
decades ago. The fact that live FMD virus research is already being 
performed on the mainland in other countries should not be dismissed by 
the GAO as it clearly demonstrates that such work can be conducted 
safely on the mainland (with appropriate biosafety and biosecurity 
protocols in place to minimize the risk of release). There are five BSL-
4 facilities currently operating in the United States in populated 
areas (Centers for Disease Control and Prevention and Georgia State 
University in Atlanta, Georgia; U.S. Army Medical Research Institute of 
Infectious Diseases at Ft. Detrick, Maryland; University of Texas 
Medical Branch in Galveston and Southwest Foundation for Biomedical 
Research in San Antonio, Texas). There has never been a public exposure 
resulting from research at a BSL-4 laboratory in the United States. DHS 
is committed to minimizing both the likelihood and the consequences of 
the release of any pathogen. 

DHS determined that there are significant benefits to constructing the 
NBAF on the mainland, including rapid diagnosis and response to 
possible foreign animal disease outbreaks, and access to more research 
programs and expertise which will allow greater research advancements. 
DI IS appreciates the independent review conducted by GAO, and takes 
seriously the observations made in the draft report of the consequences 
of a pathogen release. As part of the design process, DHS will conduct 
a site-specific biosecurity risk mitigation assessment for the 
Manhattan. Kansas site to determine the required facility design and 
engineering controls needed to adequately protect NBAF during 
operations. Risk mitigation assessments will include modeling scenarios 
to assist in developing a detailed emergency response plan to prepare 
city, state, and regional officials in the extremely unlikely event of 
a pathogen release. In response to the observations made by GAO in the 
draft report, the modeling will incorporate site-specific and regional-
specific data. 

Numerous DHS and USDA general and specific comments and corrections to 
the draft report are attached. Thank you again for the opportunity to 
comment. 

Sincerely, 

Signed by: 

Bradley I. Buswell: 
Under Secretary for Science and Technology (Acting): 

Encl: a/s: 

[End of section] 

Appendix III: GAO Contacts and Staff Acknowledgments: 

GAO Contacts: 

Nancy Kingsbury, Ph.D., (202) 512-2700, or kingsburyn@gao.gov. 

Staff Acknowledgments: 

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. 

[End of section] 

Footnotes: 

[1] FMD is a highly contagious and easily transmissible animal disease 
that affects cattle, sheep, goats, pigs, and other cloven-hoofed 
animals. It occurred in most countries of the world at some point 
during the past century and continues to occur throughout much of the 
world; although some countries have been free of FMD for some time, its 
wide host range and rapid spread constitute cause for international 
concern. 

[2] Public Law 107-296, § 310, 116 Stat. 2135, 2174 (Nov. 25, 2002), 
codified at 6 U.S.C. § 190. 

[3] See 6 U.S.C. § 542(b)(3). 

[4] HSPD-9 also mandates that the secretaries of Homeland Security, 
Agriculture, and Health and Human Services; the administrator of the 
Environmental Protection Agency; and the heads of other appropriate 
federal departments and agencies, in consultation with the director of 
the Office of Science and Technology Policy, "accelerate and expand the 
development of countermeasures against the intentional introduction or 
natural occurrence of catastrophic animal, plant, and zoonotic 
diseases." Homeland Security Presidential Directive (HSPD) 9, "Defense 
of United States Agriculture and Food," The White House, Washington, 
D.C., Jan. 30, 2004, secs. 23 and 24. [hyperlink, 
http://www.dhs.gov/xabout/laws/gc_1217449547663.shtm].  

[5] BSL-3-Ag is unique to agriculture, whose studies employ large 
agricultural animals where the facilities' barriers serve as the 
primary containment. 

[6] The NBAF's mission is to allow for basic research, diagnostic 
testing and validation, countermeasure development (i.e., vaccines and 
antiviral therapies), and diagnostic training for high-consequence 
livestock diseases with potentially devastating impacts to U.S. 
agriculture and threats to public health. 

[7] GAO, High-Containment Biosafety Laboratories: DHS Lacks Evidence to 
Conclude That Foot-and-Mouth Disease Research Can Be Done Safely on the 
U.S. Mainland, [hyperlink, http://www.gao.gov/products/GAO-08-821T] 
(Washington, D.C.: May 22, 2008). 

[8] The BKC was established in 2004 at LLNL to develop a new 
distributed knowledge management infrastructure for anticipating, 
preventing, and responding to biological terrorism. It serves as a 
national clearinghouse for biological threat agent knowledge to ensure 
that timely, authoritative, and actionable biodefense information is 
available to persons with a need to know. 

[9] The seven FMD serotypes--or closely related microorganisms 
distinguished by a characteristic set of antigens--are O, A, C, SAT-1, 
SAT-2, SAT-3, and Asia-1. They show some regionality, O being the most 
common. 

[10] Investigations concluded that the likely source of the 2007 
release was a leaking drain pipe at Pirbright that carried waste from 
contained areas to an effluent treatment plant. The virus then spread 
to local farms by contaminated mud splashing onto vehicles that, having 
unrestricted access to the contaminated area, easily drove on and off 
the site. The investigations found a failure to properly maintain the 
site's infrastructure. 

[11] Classical swine fever, also known as hog cholera and swine fever, 
is a highly contagious viral disease of swine. Vesicular stomatitis is 
a viral disease characterized by fever, vesicles, and subsequent 
erosions in the mouth and epithelium and on the teats and feet. Horses, 
cattle, and pigs are naturally susceptible; sheep and goats are rarely 
affected. 

[12] 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. 

[13] 21 U.S.C. § 113a. 

[14] Public Law 110-246, 122 Stat. 1651 (June 18, 2008). 

[15] Federal Business Opportunities, or FBO.gov, is a virtual 
marketplace in which "commercial vendors and government buyers may 
post, search, monitor, and retrieve opportunities solicited by the 
entire federal contracting community." See FedBizOpps.gov at 
[hyperlink, http://www.fbo.gov]. 

[16] Notice, National Bio-and Agro-Defense Facility (NBAF); Notice of 
Request for Expression of Interest for Potential Sites for the NBAF, 71 
Fed. Reg. 3107 (Jan. 19, 2006). 

[17] [hyperlink, http://www.gao.gov/products/GAO-08-821T]. 

[18] Rift Valley Fever is a viral disease affecting sheep, goats, and 
cattle that mosquitoes transmit between animals. There is also a human 
form of the disease. 

[19] Department of Homeland Security, National Bio-and Agro-Defense 
Facility: Final Environmental Impact Statement (Washington, D.C.: 
December 2008). [hyperlink, 
http://www.dhs.gov/xres/labs/gc_1187734676776.shtm#2]  

[20] Nipah virus infects pigs and people, in whom it causes a sometimes 
fatal form of viral encephalitis (or brain inflammation). 

[21] By "bounding," DHS meant that the scenarios represented situations 
involving the greatest impact or worst-case scenarios. 

[22] One scenario involved an infection acquired in a laboratory, which 
was not relevant to an FMD virus release because the virus does not 
generally infect humans. 

[23] This model, sponsored by the U.S. Department of Energy and the 
Nuclear Regulatory Commission, is called MELCOR Accidental Consequence 
Code System, Version 2. 

[24] LLNL performed the analyses in its role as part of Homeland 
Security, Biodefense Knowledge Center, Rapid Response, which conducts 
work for DHS. The BKC first did a quick, preliminary study in about a 
day that did not include an aerosol release scenario. In the May 29, 
2008, rapid tasker (1 week from inquiry to response), the BKC conducted 
a qualitative analysis of an aerosol release and analyzed seven 
scenarios. 

[25] This model is called the Multiscale Epidemiological/Economic 
Simulation and Analysis Decision Support system. It is one of several 
tools used in epidemiologic simulation modeling. Spread methods 
accounted for in the epidemiologic model include direct contact animal 
movement, high-risk and low-risk indirect contact, and interstate 
transportation of live animals. Interherd aerosol transmission is not a 
spread method accounted for in the epidemiologic model, according to 
the May 29, 2008, LLNL study. 

[26] According to the analyses, for scenarios that began with a single 
index case, outbreaks initiated in swine and sheep were larger, based 
on the number of animals infected. Also, outbreaks initiated in sheep 
premises resulted in the largest outbreaks, based on number of herds 
infected, except in Mississippi. The larger outbreaks (based on the 
number of animals) in Kansas and North Carolina were mainly from swine 
being infected. Simulated outbreaks in New York were small because of 
the small number of animals and herds in Suffolk and surrounding 
counties. Further, although Texas has the largest number of animals and 
herds in the county of the proposed NBAF site, the premises are 
primarily for small stocker cattle and cow/calf operations, and disease 
spread is limited in such facilities. The overall size (based on 
numbers of herds) of the outbreaks was comparable for Texas and New 
York-Plum Island. 

[27] According to the EIS, the purpose of the threat and risk 
assessment was to identify potential vulnerabilities and weaknesses 
associated with the NBAF and to recommend the most prudent measures for 
establishing a reasonable level of risk for the security and operations 
of the NBAF and public safety. 

[28] In addition, they included criminal activity by animal and 
environmental rights activists, intellectual property compromise by 
competitive intelligence agents, and bioterrorist or criminal attempts 
to obtain biological pathogens for inappropriate use. 

[29] Centers for Disease Control and Prevention and National Institutes 
of Health, Biosafety in Microbiological and Biomedical Laboratories, 
5th ed. (Washington, D.C.: U.S. Government Printing Office, 2007). 

[30] In the EIS, DHS noted that similar evaluations of the 
transportation of viral pathogens have used the Gaussian plume model: 
M. G. Garner, Potential for Wind-borne Spread of Foot-and-Mouth Disease 
Virus in Australia (Canberra: Australia Bureau of Resource Sciences, 
1995); J. H. Sorensen, "An Integrated Model to Predict the Atmospheric 
Spread of Foot-and-Mouth Disease Virus," Epidemiology and Infection 124 
(2000):577-90; T. Mikkelsen, European Geosciences Union, "Investigation 
of Airborne Foot-and-Mouth Disease Virus Transmission during Low-Wind 
Conditions in the Early Phase of the U.K. 2001 Epidemic," Atmos Chem 
Phys Discuss 3 (2003):677-703. 

[31] The HPAC model is an automated software system that provides the 
means to accurately predict the effects of hazardous material released 
into the atmosphere and its impact on civilian and military 
populations. 

[32] Parameterization is a technique modelers use to replace highly 
complex climatic processes or processes that occur on scales too small 
to be fully represented. 

[33] Pasquill stability categories define atmospheric turbulence or 
movement and are used to estimate horizontal and vertical turbulence in 
the atmosphere. The six classes of stability (A through F) depend on 
temperature profile and wind velocity. Category A is highly unstable 
and represents day situations with high solar input and higher wind 
speeds. Category F represents night scenarios with low wind speeds and 
temperature inversions. 

[34] Many of the more advanced air pollution dispersion models do not 
categorize atmospheric turbulence by the simple meteorological 
parameters commonly used in defining the six Pasquill classes. The more 
advanced models use some form of Monin-Obukhov similarity theory to 
estimate turbulence. For example, EPA's most advanced model, AERMOD, no 
longer uses the Pasquill stability classes to categorize atmospheric 
turbulence. Instead, it uses the surface roughness length and the Monin-
Obukhov length. 

[35] Most windborne spread over land is thought to be over distances 
shorter than 10 km, although spread over 60 km over land and 250 km 
over the sea are also believed to have occurred. See M. G. Garner, 
Potential for Wind-borne Spread of Foot-and-Mouth Disease Virus in 
Australia (Canberra: Australia Bureau of Resource Sciences, 1995). J. 
Gloster, R. F. Sellers, and A. I. Donaldson, "Long Distance Transport 
of Foot-and-Mouth Disease over the Sea," Veterinary Record (London) 110 
(1982):47-52, suggested that in 90 percent of outbreaks, a windborne 
spread over land covers distances of up to 10 km. The remaining 10 
percent includes spreads over 60 km or more. In a 1967 epidemic in 
Hampshire in the United Kingdom, windborne spread up to 10 km was 
considered possible (see R. F. Sellers and A. J. Forman, "The Hampshire 
Epidemic of Foot-and-Mouth Disease, 1967," Journal of Hygiene (London) 
71:1(1973):15-34.) 

[36] See, for example, O. Möhler and others, "Microbiology and 
Atmospheric Processes: The Role of Biological Particles in Cloud 
Physics," Biogeosciences 4 (2007):1059-71, who introduced and 
summarized the potential role of biological particles in atmospheric 
clouds. Biological particles, like bacteria or pollen, may be active as 
both cloud condensation nuclei and heterogeneous ice nuclei and can 
thereby contribute to initial cloud formation stages and the 
development of precipitation in giant nucleic processes. 

[37] DHS's literature review included a 2007 study of an FMD outbreak 
in southwest Kansas. According to DHS, the purpose of its literature 
search was to identify upper and lower bounds of potential economic 
losses, not to develop detailed estimates for specific sites. See D. 
Pendell and others, "The Economic Impacts of Foot-and-Mouth Disease 
Outbreak: A Regional Analysis." selected paper prepared for 
presentation at the Western Agricultural Economics Association Annual 
Meeting, Portland, Oregon, July 29 to August 1, 2007. 

[38] OIE is an intergovernmental organization responsible for improving 
animal health worldwide. It classifies countries in one or another of 
three disease states: FMD is present with or without vaccination, FMD 
is absent with vaccination, and FMD is absent without vaccination. 

[39] OIE defines zone as a clearly defined part of a territory 
containing an animal subpopulation with a distinct health status with 
respect to a specific disease for which required surveillance, control, 
and biosecurity measures have been applied for the purpose of 
international trade. 

[40] This analysis assumed the likelihood that (1) an infection would 
appear in proximal livestock premises and (2) a major outbreak could 
result from this introduction. 

[41] Criteria for assessment included total number of susceptible 
animals and large facilities, as well as total number of markets and 
number of large swine herds. 

[42] See GAO, Veterinarian Workforce: Actions Are Needed to Ensure 
Sufficient Capacity for Protecting Public and Animal Health, 
[hyperlink, http://www.gao.gov/products/GAO-09-178] (Washington, D.C.: 
Feb. 4, 2009), and National Animal Identification System: USDA Needs to 
Resolve Several Key Implementation Issues to Achieve Rapid and 
Effective Disease Traceback, [hyperlink, 
http://www.gao.gov/products/GAO-07-592] (Washington, D.C.: July 6, 
2007). 

[43] For example, the EIS stated that it was considered likely that 
deer, elk, wild boar, and other wildlife or livestock could spread 
disease over long distances. 

[End of section] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
and accountability of the federal government for the American people. 
GAO examines the use of public funds; evaluates federal programs and 
policies; and provides analyses, recommendations, and other assistance 
to help Congress make informed oversight, policy, and funding 
decisions. GAO's commitment to good government is reflected in its core 
values of accountability, integrity, and reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each 
weekday, GAO posts newly released reports, testimony, and 
correspondence on its Web site. To have GAO e-mail you a list of newly 
posted products every afternoon, go to [hyperlink, http://www.gao.gov] 
and select "E-mail Updates." 

Order by Phone: 

The price of each GAO publication reflects GAO’s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO’s Web site, 
[hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional 
information. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 

Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]: 
E-mail: fraudnet@gao.gov: 
Automated answering system: (800) 424-5454 or (202) 512-7470: 

Congressional Relations: 

Ralph Dawn, Managing Director, dawnr@gao.gov: 
(202) 512-4400: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7125: 
Washington, D.C. 20548: 

Public Affairs: 

Chuck Young, Managing Director, youngc1@gao.gov: 
(202) 512-4800: 
U.S. Government Accountability Office: 
441 G Street NW, Room 7149: 
Washington, D.C. 20548: