Biological Research
Observations on DHS's Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island Gao ID: GAO-09-747 July 30, 2009Foot-and-mouth disease (FMD) is the most highly infectious animal disease known: nearly 100 percent of exposed animals become infected with it. Although the United States has not had an outbreak of FMD since 1929, a single outbreak of FMD virus as a result of an accidental or intentional release from a laboratory on the U.S. mainland could have significant consequences for U.S. agriculture. The traditional approach to the disease, once infection is confirmed, is to depopulate infected and potentially infected livestock herds to eradicate the disease. The value of U.S. livestock sales was $140 billion in 2007; about 10 percent of this figure, or approximately $13 billion, was accounted for by export markets. The Plum Island Animal Disease Center (PIADC), on a federally owned island off the northern tip of Long Island, New York, is the only facility in the United States that studies the live FMD virus. The U.S. Department of Agriculture (USDA) was responsible for the PIADC from its opening in the 1950s until June 2003, when USDA transferred responsibility for it to the U.S. Department of Homeland Security (DHS), as required by the Homeland Security Act of 2002. The act specified that USDA would continue to have access to Plum Island to conduct diagnostic and research work on foreign animal diseases, and it authorized the president to transfer funds from USDA to DHS to operate the PIADC. Also, under Homeland Security Presidential Directive 9 (HSPD-9), the secretary of Agriculture and the secretary of Homeland Security are to develop a plan to provide safe, secure, and state-of-the-art agricultural biocontainment laboratories for researching and developing diagnostic capabilities for foreign animal and zoonotic diseases. On January 19, 2006, DHS announced that to meet its obligations under HSPD-9, it would construct and operate a new facility--the National Bio- and Agro-Defense Facility (NBAF)--containing several biosafety level 3 (BSL-3) laboratories, BSL-3 agricultural (BSL-3-Ag) laboratories, and biosafety level 4 (BSL-4) laboratories. FMD research is to be performed in a BSL-3-Ag laboratory. When fully operational, the NBAF is meant to replace the PIADC. The primary research and diagnostic focus at the PIADC is foreign or exotic diseases, including FMD virus, that could affect livestock, including cattle, pigs, and sheep. DHS stated that the PIADC was "nearing the end of its life cycle" and was lacking critical capabilities to continue as the primary facility for such work. Another reason DHS cited was the need to be close to research facilities. According to DHS, although the PIADC coordinates with many academic institutes throughout the northeast, its isolated island location means that few academic institutes are within a reasonable commuting distance; DHS believes that these are needed to provide research support and collaboration required for the anticipated NBAF program. We are doing this work to respond to the statutory mandate in the fiscal year 2009 appropriations act for DHS (Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (Public Law 110-329)). The act restricted DHS's obligation of funds for constructing the NBAF on the mainland until DHS completed a risk assessment on whether FMD work can be done safely on the U.S. mainland and we reviewed DHS's risk assessment. In our review, we specifically assessed the evidence DHS used to conclude that work with FMD can be conducted as safely on the U.S. mainland as on Plum Island, New York.
DHS developed a threat and risk analysis independent of the environmental impact statement (EIS) that identified and evaluated potential security risks--threats, vulnerabilities, and consequences--that might be encountered in operating the NBAF. They included crimes against people and property and threats from compromised or disgruntled employees. The objectives of this analysis were to present the risks and effective mitigation strategies for ensuring the NBAF's secure operation and to help DHS select the site with the fewest unique security threats. DHS concluded that the EIS and threat and risk analysis showed very little differentiation across the six sites and considered that the safety and security risks that had been identified at all sites were acceptable, with or without mitigation. Specifically, for all sites the risk was zero to low for all accident scenarios, except for an overpressure fire--an explosion from the buildup of a large amount of gas or flammable chemical in an enclosed area. The risk of an overpressure fire accident was moderate for all sites For all sites--except Plum Island--the overall risk rank was moderate, based on the potential for infection and opportunity for disease to spread through livestock or wildlife. The Plum Island site's overall risk rank was low, because the likelihood of any disease spreading beyond the island was small, since animals do not live in the vicinity and the potential for infection is less. The threat and risk assessment concluded that the insider threat would be the biggest threat to the NBAF and would be independent of the site.
GAO-09-747, Biological Research: Observations on DHS's Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island
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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]
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