High-Containment Biosafety Laboratories: DHS Lacks Evidence to	 
Conclude That Foot-and-Mouth Disease Research Can Be Done Safely 
on the U.S. Mainland (22-MAY-08, GAO-08-821T).			 
                                                                 
DHS is proposing to move foot-and mouth disease (FMD) research	 
from its current location at the Plum Island Animal Disease	 
Center--located on a federally owned island off the northern tip 
of Long Island, New York--and potentially onto the United States 
mainland. FMD is the most highly infectious animal disease that  
is known. Nearly 100 percent of exposed animals become infected. 
A single outbreak of FMD on the U.S. mainland could have	 
significant economic consequences. Concerns have been raised	 
about moving FMD research off its island location and onto the	 
U.S. mainland--where it would be in closer proximity to 	 
susceptible animal populations--as opposed to building a new	 
facility on the island. GAO was asked to evaluate the evidence	 
DHS used to support its decision that FMD work can be done safely
on the U.S. mainland, whether an island location provides any	 
additional protection over and above that provided by modern high
containment laboratories on the mainland, and the economic	 
consequences of an FMD outbreak on the U.S. mainland. In	 
preparing this testimony, GAO interviewed officials from DHS and 
USDA, talked with experts in FMD and high-containment		 
laboratories worldwide, and reviewed studies on FMD,		 
high-containment laboratories, and the economic consequences of  
FMD outbreaks. GAO also visited the Plum Island Animal Disease	 
Center and other animal biocontainment laboratories in other	 
countries.							 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-821T					        
    ACCNO:   A82176						        
  TITLE:     High-Containment Biosafety Laboratories: DHS Lacks       
Evidence to Conclude That Foot-and-Mouth Disease Research Can Be 
Done Safely on the U.S. Mainland				 
     DATE:   05/22/2008 
  SUBJECT:   Animal diseases					 
	     Biocontainment laboratories			 
	     Biological research				 
	     Data integrity					 
	     Disease control					 
	     Disease detection or diagnosis			 
	     Disease surveillance				 
	     Facility security					 
	     Federal facility relocation			 
	     Homeland security					 
	     Infectious diseases				 
	     Research and development facilities		 
	     Research program management			 
	     Research programs					 
	     Risk assessment					 
	     Risk factors					 
	     Risk management					 
	     Safety standards					 
	     Site selection					 
	     Zoonotic diseases					 
	     ARS Plum Island Animal Disease Center		 

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GAO-08-821T

This is the accessible text file for GAO report number GAO-08-821T 
entitled 'High-Containment Biosafety Laboratories: DHS Lacks Evidence 
to Conclude that Foot-and-Mouth Disease Research Can Be Done Safely on 
the U.S. Mainland' which was released on May 22, 2008. 

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Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 

GAO: 

For Release on Delivery Expected at 10:00 a.m. EDT: 

Thursday, May 22, 2008: 

High-Containment Biosafety Laboratories: 

DHS Lacks Evidence to Conclude That Foot-and-Mouth Disease Research Can 
Be Done Safely on the U.S. Mainland: 

Statement of Nancy Kingsbury, Managing Director: 

Applied Research and Methods: 

GAO-08-821T: 

GAO Highlights: 

Highlights of GAO-08-821T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives. 

Why GAO Did This Study: 

DHS is proposing to move foot-and mouth disease (FMD) research from its 
current location at the Plum Island Animal Disease Centerï¿½located on a 
federally owned island off the northern tip of Long Island, New 
Yorkï¿½and potentially onto the United States mainland. FMD is the most 
highly infectious animal disease that is known. Nearly 100 percent of 
exposed animals become infected. A single outbreak of FMD on the U.S. 
mainland could have significant economic consequences. Concerns have 
been raised about moving FMD research off its island location and onto 
the U.S. mainlandï¿½where it would be in closer proximity to susceptible 
animal populationsï¿½as opposed to building a new facility on the island. 

GAO was asked to evaluate the evidence DHS used to support its decision 
that FMD work can be done safely on the U.S. mainland, whether an 
island location provides any additional protection over and above that 
provided by modern high containment laboratories on the mainland, and 
the economic consequences of an FMD outbreak on the U.S. mainland. In 
preparing this testimony, GAO interviewed officials from DHS and USDA, 
talked with experts in FMD and high-containment laboratories worldwide, 
and reviewed studies on FMD, high-containment laboratories, and the 
economic consequences of FMD outbreaks. GAO also visited the Plum 
Island Animal Disease Center and other animal biocontainment 
laboratories in other countries. 

What GAO Found: 

GAO found that the Department of Homeland Security (DHS) has neither 
conducted nor commissioned any study to determine whether work on foot-
and-mouth disease (FMD) can be done safely on the U.S. mainland. 
Instead, in deciding that work with FMD can be done safely on the 
mainland, DHS relied on a 2002 U.S. Department of Agriculture (USDA) 
study that addressed a different question. The study did not assess the 
past history of releases of FMD virus or other dangerous pathogens in 
the United States or elsewhere. It did not address in detail the issues 
of containment related to large animal work in BSL-3 Ag facilities. It 
was inaccurate in comparing other countriesï¿½ FMD work experience with 
that of the United States. Therefore, GAO believes DHS does not have 
evidence to conclude that FMD work can be done safely on the U.S. 
mainland. 

While location, in general, confers no advantage in preventing a 
release, location can help prevent the spread of pathogens and, thus, a 
resulting disease outbreak if there is a release. Given that there is 
always some risk of a release from any biocontainment facility, most 
experts GAO spoke with said that an island location can provide 
additional protection. An island location can help prevent the spread 
of FMD virus along terrestrial routes, such as from vehicles splashed 
with contaminated mud, and may also reduce airborne transmission. Some 
other countries besides the United States have historically seen the 
benefit of an island location, with its remoteness from susceptible 
species and permanent water barriers. A recent release from the 
Pirbright facilityï¿½located in a farming community on the mainland of 
the United Kingdomï¿½highlights the risks of a release from a laboratory 
that is in close proximity to the susceptible animals and provides the 
best evidence in favor of an island location. 

Figure 1: The Plum Island Animal Disease Center: 

This figure is a photograph of the Plum Island Animal Disease Center. 

[See PDF for image] 

Source: DHS. 

[End of figure] 

FMD has no health implications for humans, but it can have significant 
economic consequences, as recent outbreaks in the United Kingdom have 
demonstrated. The economic effects of an FMD outbreak in the United 
States, however, would depend on the characteristics of the outbreak 
and how producers, consumers, and the government responded to it. 
Although estimates vary, experts agree that the economic consequences 
of an FMD outbreak on the U.S. mainland could be significant, 
especially for red meat producers whose animals would be at risk for 
diseases, depending on how and where such an outbreak occurred. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-821T]. For more 
information, contact Nancy Kingsbury at (202) 512-2700 or 
[email protected]. 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

We are pleased to be here to discuss our findings on the evidence the 
Department of Homeland Security (DHS) has used to support its decision 
that foot-and-mouth disease (FMD) work can be conducted as safely on 
the U.S. mainland as on Plum Island. 

By law, live FMD virus may be used only at a coastal island, such as 
Plum Island, unless the Secretary of Agriculture specifically 
determines that it is necessary and in the public interest to conduct 
such research and study on the U.S. mainland.[Footnote 1] The only 
facility that studies high-consequence foreign livestock diseases, such 
as FMD, in the United States is the Plum Island Animal Disease Center 
(PIADC), located on a federally owned island off the northern tip of 
Long Island, New York. 

The U.S. Department of Agriculture (USDA) was responsible for Plum 
Island from the 1950s until June 1, 2003. The Homeland Security Act of 
2002 transferred Plum Island to DHS, shifting overall responsibility 
for Plum Island to DHS, including all costs associated with PIADC's 
maintenance, operations, and security.[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 
Plum Island.[Footnote 3] 

DHS has identified PIADC as "reaching the end of its life cycle" and as 
lacking critical capabilities to continue as the primary facility for 
such work. DHS has announced that to meet the obligation of Homeland 
Security Presidential Directive/HSPD-9, it will establish a new 
facility, the National Bio and Agro-Defense Facility (NBAF).[Footnote 
4] This facility, according to DHS, would have high-containment 
laboratories able to safely contain the pathogens currently under 
investigation at PIADC--including the FMD virus.[Footnote 5] 

FMD is the most highly infectious animal disease that is known. Nearly 
100 percent of exposed animals become infected. The virus can spread 
from infected animals in various ways, including by contaminated animal 
feed or water, contaminated shoes or clothing, and contaminated 
vehicles or farm equipment. In some circumstances, the wind can spread 
the virus from farm to farm. The traditional approach, once infection 
is confirmed, is to depopulate infected and potentially infected herds. 

The United States has been free of FMD since 1929. A single outbreak of 
FMD on the U.S. mainland could have significant consequences. The value 
of U.S. livestock sales was $140 billion in 2007; about 10 percent of 
this figure, or approximately $13 billion, is accounted for by export 
markets. Concerns have been raised about moving FMD research off its 
island location and onto the U.S. mainland, where it would be in closer 
proximity to susceptible animal populations, as opposed to building a 
new facility on the island. 

You asked us to evaluate: 

1. the evidence DHS used to support its decision that FMD work can be 
done safely on the U.S. mainland, 

2. whether an island location provides any additional protection over 
and above that provided by modern high containment laboratories on the 
mainland, and: 

3. the economic consequences of an FMD outbreak on the mainland. 

To address the first question, we interviewed officials from DHS and 
USDA. We visited PIADC and talked with DHS and USDA officials who 
oversee and operate the facility, toured the animal containment areas, 
and examined the unique aspects of the island location. We obtained and 
reviewed relevant legislation and regulations governing USDA and DHS; 
literature on FMD as well as on high-containment laboratories; and 
agencies' documents, including the study DHS used to support its 
decision. In addition, we talked to the contractor who conducted the 
study for USDA in 2002 and many of the members of the expert panel used 
in the study. We also talked to experts on animal diseases and high- 
containment laboratories dealing with animal, zoonotic, and human 
pathogens, as well as representatives from the American Society for 
Microbiology, National Grange of the Order of Patrons of Husbandry, 
National Cattlemen's Beef Association, and National Pork Producers 
Council.[Footnote 6] 

For the second question, we interviewed officials from DHS and USDA and 
experts in animal diseases. We visited and talked with officials of 
some of the other facilities that are conducting FMD work, including 
the Australian Animal Health Laboratory in Geelong, Canada's National 
Centre for Foreign Animal Disease in Winnipeg, the Danish National 
Veterinary Institute on Lindholm Island, the German Federal Research 
Institute for Animal Health (Friedrich-Loeffler-Institut) on the Island 
of Riems, and the United Kingdom's (UK) Institute for Animal Health 
Pirbright facility. In addition, we talked to officials of the World 
Organisation for Animal Health (OIE) in France. 

For the third question, we obtained and reviewed studies conducted on 
the economic consequences of the FMD outbreak in the United Kingdom in 
2002 and the potential consequences of outbreaks in the United States. 

We conducted our work from March 2008 through May 2008 in accordance 
with generally accepted government auditing standards. 

Results in Brief: 

We found that DHS has not conducted or commissioned any study to 
determine whether FMD work can be done safely on the U.S. mainland. 
Instead, DHS based its decision that work with FMD virus can be done 
safely on the mainland on a 2002 USDA study that addressed a different 
question: whether it is technically feasible to conduct exotic disease 
research and diagnostics, including foot-and-mouth disease and 
rinderpest, on the U.S. mainland with adequate biosafety and 
biosecurity to protect U.S. agriculture.[Footnote 7] This approach 
fails to recognize the distinction between what is technically feasible 
and what is possible, given the potential for human error. We found 
that the study was selective in what it considered. It did not assess 
the history of releases of FMD virus or other dangerous pathogens, 
either in the United States or elsewhere. It did not address in detail 
the issues of containment related to large animal work in BSL-3 Ag 
facilities.[Footnote 8] Also, the study was inaccurate in comparing 
other countries' FMD work experience with the situation in the United 
States. Consequently, the study does not clearly support the conclusion 
that FMD work can be done safely on the mainland. 

While location, in general, confers no advantage in preventing an 
initial release, location can help prevent the spread of pathogens and, 
thus, a resulting disease outbreak if there is a release. Given that 
there will always be some risk of a release from any biocontainment 
facility, most of the experts we spoke with told us that an island 
location can provide additional protection. An island location can help 
prevent the spread of FMD virus along terrestrial routes, such as from 
vehicles splashed with contaminated mud, and may also reduce airborne 
transmission. 

Historically, not just the United States but also other countries have 
seen the benefit of an island location, with its combination of 
remoteness from susceptible species and permanent water barriers. For 
example, Denmark, Germany, and the United States decided to conduct FMD 
and related animal disease work on islands when modern containment 
technology did not yet exist. Islands were considered to be an extra 
layer of protection. However, faced with the decision today of whether 
to replace aging infrastructure on the island versus building a new 
facility on the mainland, Denmark and Germany have both decided to keep 
FMD work on their islands, given the non-zero risk of a release and the 
serious economic consequences of an outbreak on the mainland.[Footnote 
9] 

Australia has built a state-of-the-art BSL-4 laboratory at Geelong, 
south of Melbourne.[Footnote 10] However, Australia's approach is to 
avoid the risk of any release by contracting out live FMD virus work to 
foreign countries, despite the fact that it has the most sophisticated 
high-containment laboratories for such work.[Footnote 11] Canada has 
decided to conduct FMD work on the mainland. However, the location is 
downtown, where susceptible animals are not likely to be found in the 
immediate neighborhood. In addition, Canada's scope of work on FMD is 
smaller than the present FMD work at the PIADC facility or the facility 
DHS proposes. Some of the proposed U.S. sites are potentially more 
likely to pose a risk, given their closer proximity to susceptible 
animal populations. A recent release from the Pirbright facility in the 
United Kingdom highlights the risks of a release from a laboratory that 
is in close proximity to susceptible animals and provides the best 
evidence in favor of an island location. 

FMD has no health implications for humans, but it can have significant 
economic consequences, as recent outbreaks in the United Kingdom have 
demonstrated. The economic effects of an FMD outbreak in the United 
States would depend on the characteristics of the outbreak and how 
producers, consumers, and the government responded to it. Although 
estimates vary, experts agree that the economic consequences of an FMD 
outbreak on the U.S. mainland could be significant, especially for red 
meat producers, whose animals would be at risk for diseases, depending 
on how and where such an outbreak occurred. 

We discussed our findings with both DHS and USDA. DHS officials told us 
that in addition to the SAIC study, the results of the EIS would be 
used to determine the safety of FMD work on the mainland. Previously, 
DHS had stated categorically that the SAIC study allowed them to 
conclude that FMD work can be done safely on the mainland. In light of 
this, the recent DHS statement about the results of EIS clearly 
conflict with the earlier position. Without detail information, it is 
impossible to determine whether or not the EIS would contribute 
significantly to addressing this issue. We asked but DHS would not 
provide any information on what analysis they would do as part of the 
EIS concerning biosafety. For example, it is not known to us whether or 
not EIS will include an analysis of the factors that may lead to a 
release of FMD virus from containment laboratories, for example, a 
laboratory air pressure system going positive. 

USDA officials stated that the German facility no longer meets the 
actual definition of an island since it is now connected to the 
mainland by road. We noted this in our testimony. 

USDA officials also cited the Centers for Disease Control and 
Prevention BSL-4 laboratory in Atlanta as an example of the safe 
operation of high-containment laboratory in the middle of a densely 
populated area. We believe that this example is not an appropriate 
comparison to the FMD work involving large animals in BSL-3 Ag 
laboratories. In a BSL-4 laboratory, work is done within a biological 
safety cabinet, which provides the primary level of containment. 
Accordingly, there is no contact between the human operator and the 
infective material. The laboratory provides the secondary containment 
and the laboratory staff is required to wear special protective 
equipment to prevent any exposure to the pathogens. Furthermore, 
according to experts we spoke with, the most dangerous human pathogens 
have, fortunately, a much lower level of infectivity and 
transmissibility than FMD. That is why we believe that this comparison 
is not valid. 

Unique risks are associated with BSL-3 Ag facilities, in contrast, 
where the facility itself is considered the primary containment area. 
Because large animals cannot be handled within a biological safety 
cabinet, they are free to move around in a BSL-3 Ag laboratory, where 
the laboratory walls provide the primary containment. Another important 
distinction in a BSL-3 Ag laboratory is that there is extensive direct 
contact between the human operator and the infected animal. It is also 
worth noting that the infectious dose of FMD for cattle is about 10 
virus particles. Because the virus can be carried in a person's lungs, 
nostrils, or other body parts, the human becomes a potential avenue by 
which the virus can escape the facility. This potential avenue for 
escape of the virus outside the containment does not exist in BSL-4 
laboratory. 

Background: 

FMD Is a Highly Contagious Animal Disease: 

FMD is a highly contagious animal disease. [Footnote 12] It affects 
cloven-hoofed animals such as cattle, sheep, goats, and pigs, and has 
occurred in most countries of the world at some point during the past 
century. [Footnote 13] It has 7 types and over 80 subtypes. Immunity 
to, or vaccination for, one type of the virus does not protect animals 
against infection from the other types. FMD-infected animals usually 
develop blister-like lesions in the mouth, on the tongue and lips, on 
the teats, or between the hooves. They salivate excessively or become 
lame. Other symptoms include fever, reduced feed consumption, and 
miscarriages. Cattle and pigs, which are very sensitive to the virus, 
show disease symptoms after a short incubation period of 3 to 5 days. 
The incubation period in sheep is considerably longer, about 10 to 14 
days, and the clinical signs of the disease are usually mild and may be 
masked by other diseases, thereby allowing FMD to go 
unnoticed.[Footnote 14] 

The mortality rate for young animals infected with FMD varies and 
depends on the species and strain of the virus; in contrast, adult 
animals usually recover once the disease has run its course. However, 
because the disease leaves them severely debilitated, meat-producing 
animals do not normally regain their lost weight for many months, and 
dairy cows seldom produce milk at their former rate. Therefore, the 
disease can cause severe losses in the production of meat and milk. 

The FMD virus is easily transmitted and spreads rapidly. Before and 
during the appearance of clinical signs, infected animals release the 
virus into the environment through respiration, milk, semen, blood, 
saliva, and feces. The virus may become airborne and spread quickly if 
pigs become infected because pigs prolifically produce and excrete 
large amounts of the virus into the air. Animals, people, or materials 
that are exposed to the virus can also spread FMD by bringing it into 
contact with susceptible animals. For example, the virus can spread 
when susceptible animals come in contact with contaminated: 

* animals; 

* animal products, such as meat, milk, hides, skins, and manure; 

* transport vehicles and equipment; 

* clothes or shoes worn by people; and: 

* hay, feedstuffs, or veterinary biologics.[Footnote 15] 

FMD virus is the most infectious animal disease-causing virus. It has 
been determined that for certain strains, the dose required to infect 
cattle or sheep through inhalation is about 10 organisms (10 1 TCID50). 
Infected pigs produce immense amounts of airborne virus. An infected 
pig exhales 400 million organisms per day (10 8.6 TCID50). The 
sensitivity of cattle to infection and the high levels of airborne 
virus produced by infected pigs illustrate that the airborne spread of 
infection is another important factor in FMD outbreaks. 

FMD occurs throughout much of the world, and although some countries 
have been free of FMD for some time, its wide host range and rapid 
spread represent cause for international concern. After World War II, 
the disease was widely distributed across the globe. In 1996, endemic 
areas included Asia, Africa, and parts of South America. In North 
America, the last outbreaks of FMD for the United States, Canada, and 
Mexico occurred in 1929, 1952, and 1953, respectively. 

North America, Australia, and Japan have been free of FMD for many 
years. New Zealand has never had a case of FMD. Most European countries 
have been recognized as disease free, and countries belonging to the 
European Union have stopped FMD vaccination. 

Plum Island Animal Disease Center: 

Plum Island is a federally owned 840-acre island off the northeastern 
tip of Long Island, New York. Scientists working at the facility are 
responsible for protecting U.S. livestock against foreign animal 
diseases that could be accidentally or deliberately introduced into the 
United States. Plum Island's research and diagnostic activities stem 
from its mission to protect U.S. animal industries and exports from 
accidental or deliberate introduction of foreign animal 
diseases.[Footnote 16] Plum Island's scientists identify the pathogens 
that cause foreign animal diseases and work to develop vaccines to 
protect U.S. livestock.[Footnote 17] The primary research and 
diagnostic focus at Plum Island is foreign or exotic diseases that 
could affect livestock, including cattle, pigs, and sheep. In addition 
to FMD and classical swine fever, other types of livestock diseases 
that have been studied at Plum Island include African swine fever, 
rinderpest, and various pox viruses, such as sheep and goat pox. 

Some of the pathogens maintained at Plum Island are highly contagious; 
therefore, research on these pathogens is conducted in a biocontainment 
area that has special safety features designed to contain them. If 
accidentally released, these pathogens could cause catastrophic 
economic losses in the agricultural sector. The biocontainment area 
includes 40 rooms for livestock and is the only place in the United 
States that is equipped to permit the study of certain contagious 
foreign animal diseases in large animals. USDA uses this biocontainment 
area for basic research, for diagnostic work, and for the clinical 
training of veterinarians in the recognition of foreign animal 
diseases. DHS now shares bench space with USDA in the biocontainment 
area for its applied research. The North American Foot-and-Mouth 
Disease Vaccine Bank is also located on Plum Island.[Footnote 18] 

USDA was responsible for Plum Island until June 1, 2003, when 
provisions of the Homeland Security Act of 2002 were implemented that 
transferred Plum Island, including all its assets and liabilities, to 
DHS.[Footnote 19] This action shifted overall responsibility for Plum 
Island to DHS, including all the costs associated with the facility's 
maintenance, operations, and security. The Act specified that USDA 
would continue to have access to Plum Island to conduct diagnostic and 
research work on foreign animal diseases, and it authorized the 
President to transfer funds from USDA to DHS to operate Plum 
Island.[Footnote 20] 

Plum Island is now operated as part of a broader joint strategy 
developed by DHS and USDA to protect against the intentional or 
accidental introduction of foreign animal diseases. Under the direction 
of DHS's Science and Technology Directorate, the strategy for 
protecting livestock also includes work at DHS's National Center for 
Food Protection and Defense and at its National Center for Foreign 
Animal and Zoonotic Disease Defense, as well as at other centers within 
the DHS homeland security biodefense complex. These include the 
National Biodefense Analysis and Countermeasures Center and the 
Lawrence Livermore National Laboratory. The strategy calls for building 
on the strengths of each agency's assets to develop comprehensive 
preparedness and response capabilities. 

National Bio and Agro-Defense Facility: 

Homeland Security Presidential Directive 9 tasks the Secretary of 
Agriculture and the Secretary of Homeland Security to develop a plan to 
provide safe, secure, and state-of-the-art agriculture biocontainment 
laboratories for the research and development of diagnostic 
capabilities for foreign animal and zoonotic diseases. To partially 
meet these obligations, DHS has asked the Congress to appropriate funds 
to construct NBAF, a new facility. This facility would house high- 
containment laboratories able to handle the pathogens currently under 
investigation at PIADC, as well as other pathogens of interest. 

DHS selected five potential sites for NBAF in July 2007 and must 
prepare an environmental impact statement (EIS) for each site.[Footnote 
21] According to DHS, although not included in the competitive 
selection process, the DHS-owned PIADC will now be considered as a 
potential NBAF site, and DHS will also prepare an EIS for Plum Island. 
(See table 1.) 

Table 1: Final Candidate Sites for the Proposed National Bio and Agro- 
Defense Facility: 

Candidate: Department of Homeland Security; 
Site: Plum Island, N.Y. 

Candidate: Georgia Consortium for Health and Agro-Security; 
Site: University of Georgia, Athens, Ga. 

Candidate: Gulf States Bio and Agro-Defense Consortium; 
Site: Flora Industrial Park, Madison County, Miss. 

Candidate: Heartland Bio Agro Consortium; 
Site: Kansas State University, Manhattan, Kans. 

Candidate: North Carolina Consortium for the NBAF; 
Site: Umstead Research Farm, Granville County, N.C. 

Candidate: Texas Biological and Agro-Defense Consortium; 
Site: Texas Research Park, San Antonio, Tex. 

Source: DHS, [hyperlink, 
http://www.dhs.gov/xres/labs/gc_1184180641312.shtm], and 72 Federal 
Register (July 31, 2007): 41764. 

[End of table] 

DHS has asked for public comment on the selection process. Following 
completion of the environmental impact statements and public hearings, 
DHS expects to choose a site by October 2008 and to open NBAF in 2014. 
According to DHS officials, the final construction cost will depend on 
the site's location and may exceed the currently projected $451 
million. Additional expenses, such as equipping the new facility and 
relocating existing personnel and programs, may reach $100 million. DHS 
has not yet determined what action to take with respect to PIADC when 
construction of NBAF has been completed.[Footnote 22] 

Evidence That FMD Work Can Be Conducted Safely on the U.S. Mainland Is 
Lacking: 

We found that DHS has neither conducted nor commissioned any study to 
determine whether FMD work can be done safely on the U.S. mainland. 
Instead, DHS relied on a study that USDA commissioned and a contractor 
conducted in May 2002 that examined a different question: whether it is 
technically feasible to conduct exotic disease research and 
diagnostics, including FMD and rinderpest, on the U.S. mainland with 
adequate biosafety and biosecurity to protect U.S. agriculture. 
[Footnote 23] This approach fails to recognize the distinction between 
what is technically feasible and what is possible, given the potential 
for human error. DHS told us that this study has allowed it to conclude 
that it is safe to conduct FMD work on the U.S. mainland. 

In addition to a number of other methodological problems with the 
study, we found that it was selective in what it considered in order to 
reach its findings.[Footnote 24] In particular, the study: 

1. did not assess the history of releases of FMD virus or other 
dangerous pathogens, 

2. did not address in detail the issues related to large animal work in 
BSL-3 Ag facilities, and: 

3. was inaccurate in comparing other countries' FMD work experience 
with that of the United States. 

A comprehensive analysis to determine if FMD work could be conducted 
safely on the U.S. mainland would have considered these points, at a 
minimum. DHS did not identify or remedy these deficiencies before using 
the USDA study to support its conclusions. Consequently, we believe DHS 
does not have evidence to conclude that FMD work can be done safely on 
the U.S. mainland.[Footnote 25] 

The Study Did Not Examine the Evidence from Past Releases of FMD or 
Other Dangerous Pathogens: 

We found no evidence that the study examined data from past releases of 
FMD--particularly the release of FMD on Plum Island in 1978--or the 
history of internal releases at PIADC. The study did not assess the 
general history of accidents within biocontainment laboratories, and it 
did not consider the lessons that can be learned from a survey of the 
causes of such accidents. Such a survey would show that technology and 
operating procedures alone cannot ensure against a release, since human 
error can never be completely eliminated and since a lack of commitment 
to the proper maintenance of biocontainment facilities and their 
associated technology--as the Pirbright facility showed--can cause 
releases. 

The study panel members we interviewed said that no data on past 
accidents with or releases of either FMD or other pathogens was 
systematically presented or discussed. Rather, the panel members 
recalled that they relied on their own knowledge of and experience with 
the history of releases in a general discussion. 

The release of FMD virus from facilities is very rare. In fact, the 
incidence of the release of any dangerous pathogen from modern 
containment facilities is quite low. During the vast majority of the 
time, such facilities have been operating safely. Some releases have 
occurred, however. Table 2 lists known and attributed releases of FMD 
virus from laboratories worldwide, including those that produce 
vaccines. 

Table 2: Years Foot-and-Mouth Virus Is Known or Believed to Have Been 
Released from Laboratories: 

Year: 1960, Jan; 
Country: United Kingdom. 

Year: 1968; 
Country: Denmark. 

Year: 1969; 
Country: Czechoslovakia. 

Year: 1972; 
Country: Hungary. 

Year: 1974; 
Country: Germany. 

Year: 1975; 
Country: Czechoslovakia. 

Year: 1976; 
Country: Germany. 

Year: 1977; 
Country: Germany. 

Year: 1978, Sept; 
Country: United States. 

Year: 1979; 
Country: Spain. 

Year: 1987; 
Country: Germany. 

Year: 1988; 
Country: Germany. 

Year: 1993; 
Country: Russia. 

Year: 2007, July; 
Country: United Kingdom. 

Source: GAO analysis of UK's Department of Environment, Food, and Rural 
Affairs. 

[End of table] 

A particular deficiency in the 2002 USDA study was the omission of any 
explicit analysis of the release of FMD virus from Plum Island itself 
in 1978. In September of that year, FMD virus was found to have 
infected clean animals being held outside the laboratory compound in 
the quarantined animal supply area of PIADC. The exact route by which 
the virus escaped from containment and subsequently infected the animal 
supply was never definitely ascertained. An internal investigation 
concluded that the most probable routes of escape of the virus from 
containment were (1) faulty air balance of the incinerator area, (2) 
leakage through inadequately maintained air filter and vent systems, 
and (3) seepage of water under or through a construction barrier near 
the incinerator area. Animal care workers then most likely carried the 
disease back to the animal supply area on the island, where it infected 
clean animals being held for future work. (See table 3.) 

Table 3: Deficiencies Noted as Contributing to a 1978 Release of FMD 
Virus at Plum Island: 

Issue: Air balance; 
Deficiency: Deficient recordkeeping. 

Issue: Air balance; 
Deficiency: Exhaust air filters in poor state of repair. 

Issue: Air balance; 
Deficiency: Improperly wired exhaust air handling units. 

Issue: Air balance; 
Deficiency: Failure to follow normal procedures. 

Issue: Exhaust air filters; 
Deficiency: Failure to inspect and test new filters after changing. 

Issue: Exhaust air filters; 
Deficiency: Failure to maintain filter gaskets. 

Issue: Exhaust air filters; 
Deficiency: Insufficient personnel. 

Issue: Movement of personnel; 
Deficiency: Change in procedures. 

Issue: New construction; 
Deficiency: Containment barrier removed before building replacement 
barrier. 

Issue: New construction; 
Deficiency: Improperly built temporary construction barrier. 

Source: GAO analysis of USDA data. 

[End of table] 

An analysis of the deficiencies underlying these probable routes of 
escape noted during the investigation show that all were related to 
human error and that none were related to insufficient containment 
technology. Any one of these deficiencies could happen in a modern 
facility, since they were not a function of the technology or its 
sophistication, procedures or their completeness, or even, primarily, 
the age of the facility. The deficiencies were errors in human judgment 
or execution and, as such, could occur today as easily as they did in 
1978. 

In addition, a number of incidents at PIADC have resulted in internal 
releases such that animals within the laboratory compound inadvertently 
became infected, although no FMD virus was released outside the 
facility. These incidents show that technology sometimes fails, 
facilities age, and humans make mistakes. Table 4 lists known internal 
releases of FMD virus at PIADC since 1971. 

Table 4: Internal Releases of Foot-and-Mouth Virus at Plum Island, 1971-
2004: 

Date: Sept. 1971; 
Incident: A scientific publication in the proceedings of the 75th 
Annual Meeting of the U.S. Animal Health Association in 1971 identified 
the accidental infection of two steers. The infection was believed to 
have been caused by an air leak found in a door gasket. This resulted 
in an infectious aerosol being drawn into the room because of lower air 
pressure. Two steers in the acute clinical stage of infection with FMD 
had been moved through an adjacent corridor; 
5 days later, the two steers maintained in the room had clinical signs 
and lesions of FMD of the same virus type as the animals in the 
adjacent corridor. The door seals in use at that time were not self- 
inflating. This problem is addressed today with inflatable seals that 
close the gap around doors and prevent aerosol entry; 
Probable cause: An air leak in a door gasket. 

Date: Apr.12, 1974; 
Incident: Two steers in the West Animal Wing developed symptoms of FMD. 
The animals had never been inoculated with intentionally exposed to any 
infectious agents, but both exhibited signs of disease and both were 
determined to be infected with FMD. An investigation determined that 
FMD probably came into the animal room through leaks in the walls. A 
power failure may also have resulted in a difference in pressure 
between two rooms, causing virus to flow from an infected room into the 
one housing the steer. Preventative maintenance of the rooms was 
conducted to prevent re-occurrence; 
Probable cause: Leaks in the walls combined with a power failure. 

Date: Aug. 21, 1980; 
Incident: Eighteen steers being used in a vaccine trial had been 
vaccinated with a Type C PIADC-produced FMD vaccine. Before challenge, 
approximately half the animals were found to have fever and lesions 
indicative of FMD. Further study identified that the animals had Type O 
and Type C antibodies. Because they had not been vaccinated for the 
Type O strain, these antibodies were related to an unknown exposure. 
The actual cause of this outbreak was not identified, but it could have 
been a mechanical transfer in which a laboratory worker carried the 
virus into the facility and transmitted it to the animals; 
Probable cause: Mechanical transfer by a laboratory worker. 

Date: Feb. 24, 1981; 
Incident: Four steers vaccinated 60 days earlier with FMD Type O were 
found to be infected with Type A. The actual cause of this incident was 
not identified; 
it was determined that cross- contamination from other areas in the 
laboratory was the most likely cause; 
Probable cause: Cross-contamination from an unknown source. 

Date: May 26, 1987; 
Incident: One of two Heifers housed in the East Animal Wing was found 
to be infected with FMD without previous inoculation or known exposure 
to the virus. On testing, the animal was found to be infected with FMD 
virus Type O. Investigation determined that Type O virus had been used 
in research experiments in two nearby rooms. The infected animals in 
these other rooms had been euthanized and the carcasses transported 
down the outside corridor. It was determined that the potential cause 
of the incident was fluids leaking during transport or an aerosol 
created from the bags used for transport. Negative air pressure in the 
animal room could then have resulted in cross-contamination from the 
hallway. Actions were taken to replace equipment used in transport and 
to decontaminate corridors more thoroughly; 
Probable cause: Fluids leaking during transport of carcasses. 

Date: June 24, 2004; 
Incident: Two cattle in the East Wing, Room 1178, not involved in live 
virus research were observed with clinical signs of FMD. Testing 
identified them as being infected with Type O FMD. In addition, on July 
19, 2004, four pigs in a separate, Orient Wing room not involved in 
live virus research were observed with clinical FMD. Subsequent testing 
revealed a different strain Type O. Although no specific cause was 
found for either incident, the most likely cause was cross-
contamination from other areas in the laboratory. New animal care 
protocols were instituted to restrict direct access from the 
laboratories to the animal wings. The new protocols included a single 
point of entrance to animal wings for authorized personnel who had 
undergone extensive training in biosafety measures, laboratory clothing 
exchanged before entering the animal wing, mandatory showering on 
exiting from animal rooms (even if they contained uninfected animals), 
and decontamination of all laboratory samples coming in or being 
removed from the animal rooms. Since this new control was initiated, 
there have been no other instances of cross-contamination inside the 
animal wing; 
Probable cause: Cross-contamination from an unknown source. 

Source: GAO analysis of DHS and USDA data. 

[End of table] 

These incidents involved human error, lack of proper maintenance, 
equipment failure, and deviation from standard operating procedures. 
Many were not a function of the age of the facility or the lack of 
technology and could happen in any facility today. While these 
incidents did not directly result in any external release, they could 
have been useful in the 2002 study in illustrating the variety of ways 
in which internal controls--especially in large animal biocontainment 
facilities--can be compromised. 

Given the rarity of the release of FMD virus from laboratories, and how 
relevant its release is to the question of moving FMD work off its 
present island location, we believe that the 2002 study was remiss in 
not more explicitly considering this matter. In fact, members of the 
panel we spoke with could recall little, if any, discussion of 
incidents of release at Plum Island. 

Beyond the history of incidents at Plum Island, we found no evidence 
that the study considered the history of accidents in or releases from 
biocontainment facilities generally. Had the study considered this 
history, it would have shown that no facility for handling dangerous 
pathogens can ever be completely safe and that no technology can be 
totally relied on to ensure safety. 

The study found that "today's technology is adequate to contain any 
biosafety risks at any site."[Footnote 26] While we agree that 
technology--biocontainment facilities, filtration technologies, and the 
like--has come a long way and is a critical component of biosafety, we 
believe that it is inadequate by itself in containing biosafety risks. 
A comprehensive biosafety program involves a combination of 
biocontainment technology, proper procedures, and properly trained 
people. The study also concurred that "biosafety is only as effective 
as the individual who practices it."[Footnote 27] 

Even with a proper biosafety program, human error can never be 
completely eliminated. Many experts told us that the human component 
accounts for the majority of accidents in high-containment 
laboratories. This risk persists, even in the most modern facilities 
and with the latest technology. The 2002 study, in fact, acknowledged 
this, although it did not elaborate on the critical role that people 
play in keeping biocontainment laboratories safe when it stated that 
"biosafety is only as effective as the individual who practices it." 
The study's summary conclusion that "biocontainment technology allows 
safe research" is, therefore, disingenuous.[Footnote 28] 

Finally, as we have reported previously, the maintenance of any 
biocontainment facility or technology plays a critical role in 
biosafety. [Footnote 29] For example, the lack of proper maintenance 
was one of the probable routes of escape in the 1978 release at Plum 
Island. High-containment laboratories are highly sophisticated 
facilities that require specialized expertise to design, construct, 
operate, and maintain. Because they are intended to contain dangerous 
microorganisms, usually in liquid or aerosol form, even minor 
structural defects--such as cracks in the wall, leaky pipes, or 
improper sealing around doors--can often have severe consequences. For 
example, leaking drainage pipes was determined to be the likely cause 
of the FMD outbreak at Pirbright in 2007. 

According to the experts we talked with, failure to budget for and 
conduct regular inspections and maintenance of biocontainment 
facilities is a risk to which even the most modern facilities are 
susceptible. All the experts we talked with, including the panel 
members who contributed to the 2002 study, emphasized the importance of 
effective maintenance and the need to protect maintenance budgets from 
being used for other purposes. One official told us, for example, that 
as his containment facility ages, he is spending more and more of his 
operating budget on maintenance and that, in fact, he is having to 
offset the rise in maintenance costs from other categories of funding 
within his overall budget. 

The Study Did Not Address in Detail the Issues of Containment Related 
to Large Animals Infected with FMD: 

The 2002 study did not address in detail the issues of containment 
related to large animals like cattle and pigs, which present problems 
very different from those of laboratory animals like rats, mice, and 
guinea pigs. It did not address the unique risks associated with the 
special containment spaces required for large animals or the impact of 
highly concentrated virus loads on such things as the air filtration 
systems. 

Large animals cannot be kept in containers. They must be allowed 
sufficient space to move around in. Handling large animals within 
confined spaces--a full size cow can weigh up to 1,430 pounds--can 
present special dangers for the scientists as well as the animal 
handlers. Moving carcasses from contained areas to necropsy or 
incineration poses additional risks. For example, one of the internal 
releases of FMD virus at PIADC happened in transporting large animal 
carcasses from contained rooms through to incineration. 

Although it could not have been known to the study group in 2002, 
transferring FMD work to NBAF is to be accompanied by an increase in 
both scope and complexity over the current activities at PIADC. These 
increases in scope and complexity would mean an increase in the risk 
associated with work at the new facility. For example, the proposed BSL-
3 Ag space at the new NBAF is projected to be almost twice the size of 
the space currently at PIADC and is to accommodate many more large 
animals. USDA's Agricultural Research Service animal holding area 
requirements at PIADC specify space for 90 cattle, 154 swine, or 176 
sheep (or combinations thereof). Translational studies will involve 
clinical trials with aerosolized FMD virus challenging groups of 30 to 
45 animals and lasting 3 to 6 months. This is contrasted with about 16 
large animals that PIADC can process today.[Footnote 30] 

Moreover, unique risks are associated with BSL-3 Ag facilities, where 
the facility itself is considered the primary containment area. In a 
standard BSL-3 laboratory, in contrast, work is done within a 
biological safety cabinet, which provides the primary level of 
containment, eliminating direct contact between the human operator and 
infected material. The outer parts of the facility walls thus provide a 
secondary barrier. Because large animals cannot be handled within a 
biological safety cabinet, they are free to move around in a BSL-3 Ag 
laboratory, where the laboratory walls provide the primary 
containment.[Footnote 31] 

An important difference between a standard BSL-3 laboratory, such as 
those used with human pathogens, and a BSL-3 Ag laboratory therefore is 
that in the latter there is extensive direct contact between the human 
operator and the infected animal and, consequently, the virus. Because 
the virus can be carried in a person's lungs, nostrils, or other body 
parts, the human becomes a potential avenue by which the virus can 
escape the facility. Special biosafety procedures are needed--for 
example, a full shower upon exiting containment, accompanied by 
expectorating to clear the throat and blowing through the nose to clear 
the nasal passages. Additionally, a 5-to-7-day quarantine period is 
usually imposed on any person who has been within containment where FMD 
virus is present, a tacit acknowledgment that humans can carry the 
disease out with them even after these additional procedures. Although 
the study mentioned these matters, it gave no indication that these 
unique risks associated with working in large animal biocontainment 
facilities informed the study's eventual findings. 

We also found that the study did not consider other safety issues 
specific to FMD. For example, the study did not look at the likely 
loads that air filtration systems have to deal with, especially in the 
case of pigs infected with FMD virus--which, through normal expiration, 
excrete very large amounts of virus-laden aerosols. Properly fitted and 
maintained high-efficiency particulate air (HEPA) filters are a key 
factor in all modern biocontainment facilities and have a record of 
being highly effective in keeping aerosolized pathogens, including 
viruses, contained. Nevertheless, they do not represent an absolute 
barrier. The typical standard for such filters is that they must 
operate with an efficiency of at least 99.97 percent.[Footnote 32] 
Often the highest level-containment laboratories use two HEPA filters 
in series, in addition to prefiltration systems, to gain increased 
efficiency. However, we found no indication that the study examined 
specific filtration issues with the FMD virus or that it questioned the 
efficiency of such systems specifically in relation to a high-volume 
challenge of virus, a concern that, while remote, should not have been 
dismissed, given the very low dose of FMD virus required for animals to 
become infected.[Footnote 33] 

The Study Was Inaccurate in Comparing Other Countries' FMD Work 
Experience with the Situation in the United States: 

The study cited the experience of three countries around the world in 
working with FMD--Australia, Canada, and the United Kingdom. While the 
study cited Australia as a foreign precedent, it noted that Australia 
has not conducted any FMD work on the mainland. In fact, Australia--by 
law--does not allow any FMD work on the mainland. In this respect, it 
is even more restrictive than the United States. Australia maintains a 
ban on live virus FMD work at all its laboratories, whether on 
mainland, island, or peninsula, including the laboratory at Geelong-- 
considered by many to be the premier laboratory in the world in terms 
of state-of-the-art animal containment technology. Australia mitigates 
the risk FMD poses to its livestock by outsourcing its FMD work to 
other countries.[Footnote 34] 

The Canadian laboratory at Winnipeg was not in operation at the time of 
the 2002 study and is not appropriately compared to the U.S. situation. 
Canada has decided to conduct FMD work on the mainland. However, it is 
in a downtown location where there is little likelihood that 
susceptible animals will be in the immediate neighborhood. In addition, 
its scope of work for FMD is smaller than the present FMD work at the 
PIADC facility or the proposed facility. The proposed U.S. sites are 
potentially more likely to pose a risk, given their closer proximity to 
susceptible animal populations. 

The 2002 study used the U.K. Pirbright facility as an example of a 
precedent for allowing FMD work on the mainland. The study participants 
could not have known in 2002, however, that an accidental release of 
FMD virus at the Pirbright facility in 2007 led directly to eight 
separate outbreaks of FMD on farms surrounding the Pirbright 
laboratory. This fact highlights the risks of release from a laboratory 
that is in close proximity to susceptible animals and provides the best 
evidence in favor of an island location. 

Finally, the study did not consider the German and Danish situations. 
For example, all FMD work with large animals in Germany is restricted 
to Riems, an island just off the northeastern coast of Germany in the 
Baltic Sea.[Footnote 35] FMD work in Germany was originally restricted 
to the island in the1910s. During the post-World War II period, when 
Riems was controlled by East Germany, West Germany maintained a 
separate mainland facility for its FMD research, but after re- 
unification, Germany again decided to restrict all FMD research to 
Riems and disestablished the mainland facility. Construction is 
currently under way to expand the facility on the island at Riems. 

Similarly, Denmark restricts all FMD work to the National Veterinary 
Institute Department of Virology, on the island of Lindholm. The Danish 
government has recently made a further commitment to Lindholm and has 
rebuilt a new BSL-3 Ag laboratory exclusively for FMD work on the 
island. 

Given That Releases Can Occur from Any Biocontainment Facility, an 
Island Location Can Provide Additional Protection: 

While location confers no advantage in preventing a release, location 
can help prevent the spread of FMD virus and a resulting disease 
outbreak, if there is a release. An island location can help prevent 
the spread of FMD virus along terrestrial routes, such as by vehicles 
splashed with contaminated mud or other material. An examination of the 
empirical evidence of past FMD releases from research facilities shows 
that an island location can help keep a release from becoming a more 
general outbreak. Another benefit of an island location is that it 
provides a permanent geographical barrier that may not be impregnable 
but that can more easily allow the Office International des Epizooties 
(OIE) to declare the rest of the U.S. mainland disease-free from FMD if 
there happened to be a release on the island.[Footnote 36] 

Experts we spoke with--including a number of the expert panel members 
from the 2002 study--agreed that an island location provides additional 
protection. They agreed that all other factors being equal, FMD 
research can be conducted more safely on an island than in a mainland 
location.[Footnote 37] 

A comparison of the releases at Plum Island in 1978 and Pirbright in 
2007 provides evidence that an island location can help keep a release 
from becoming a more general outbreak. In September 1978, FMD virus was 
found to have been released from containment at PIADC. The exact route 
of escape was never definitely ascertained, but clean animals held on 
the island in the animal supply area outside the laboratory compound 
became infected with FMD. 

However, no virus was ever found off the island. In fact, when the 
subsequent investigation by USDA's Animal and Plant Health Inspection 
Service on the mainland of Long Island found that no spread of FMD, 
OIE--in consideration of PIADC's island location--continued to 
officially consider the United States as a whole free from FMD. This 
was a significant declaration that allowed the continued unrestricted 
export of U.S. animal products from the mainland. 

In summarizing the 1978 FMD virus release, the PIADC Safety 
Investigation Committee identified three main PIADC lines of defense 
that stood as barriers against the escape of disease agents: (1) the 
design, construction, and operation of its laboratory buildings; (2) 
its restrictions on the movement of personnel, materials, supplies, and 
equipment; and (3) the island location.[Footnote 38] This internal 
investigation concluded that although the first two barriers had been 
breached, probably by human error, the final line of defense--the 
island location--succeeded in containing the release from becoming a 
wider outbreak beyond PIADC itself. 

The 1978 release at Plum Island can be compared to the release at 
Pirbright in the summer of 2007. Pirbright is located on the mainland 
of Great Britain in Surrey, a semi-agricultural area just southwest of 
London. The U.K. Institute for Animal Health and Merial, a commercial 
vaccine production plant, are collocated there, and both work with FMD 
virus. The site is surrounded by a number of "hobby farms," on some of 
which 40 to 50 cattle are bred and raised. In summer 2007, cattle on 
farms near the Pirbright facility became infected with FMD. Subsequent 
investigations concluded that the likely source of the release was a 
leaking drainage pipe at the facility that carried waste from the 
contained areas to an effluent treatment plant. The virus was then 
spread onto local farms by the splashing of contaminated mud onto 
vehicles that had unrestricted access to the contaminated area and 
could easily drive onto and off the site. The investigations determined 
that there had been a failure to properly maintain the site's 
infrastructure. In all, eight separate outbreaks occurred over a 2- 
month period. 

A key difference, of course, between the Pirbright incident in 2007 and 
the incident at Plum Island in 1978 is that virus did not spread off 
the Plum Island. 

Similarly, escapes in 1968 in Denmark from the Lindholm facility and in 
the 1970s in Germany from the Riems facility, when compared to 
Pirbright in 2007, also demonstrate the benefit of an island location 
in containing a release. 

An Island Facility Could More Easily Allow the United States to 
Maintain Disease-Free Status If a Release Were to Occur: 

Since 1996, OIE has provided a procedure for officially recognizing the 
sanitary status of countries with regard to particular animal diseases, 
including FMD. A country can apply for and be granted disease-free 
status if it can prove that a disease is not present in the country. Ad 
hoc groups of international experts examine countries' applications for 
official recognition of sanitary status. An elected Specialist 
Commission reviews the recommendations of these groups and either 
accepts or rejects them. 

If an outbreak does occur, procedures exist for countries to regain 
their disease-free status. This offers significant economic benefit, 
because export bans can exist for countries not considered disease- 
free. In 2002, GAO reported that an export ban on U.S. livestock 
products because of an FMD outbreak in the United States, similar to 
the 2001 outbreak in the United Kingdom, could result in losses of $6 
billion to $10 billion a year while the nation eradicated the disease 
and regained disease-free status.[Footnote 39] 

Instead of revoking the U.S. disease-free status in response to the 
1978 release at Plum Island, OIE continued to consider the United 
States as a whole free from FMD. This was because of the facility's 
island location. This status from OIE allowed the United States to 
continue exporting animal products from the mainland after the release 
was identified. However, these OIE officials said that if a similar 
release were to occur from a facility on the U.S. mainland, OIE would 
most likely not be able to declare the United States disease- 
free.[Footnote 40] In their view, the island location provides a 
natural "zoning" ability that, under OIE's rules, more easily allows 
the country to prove the compartmentalization that is necessary for 
retaining "disease-free" status. 

The Economic Consequences of an FMD Outbreak in the United States Could 
Be Significant: 

While humans cannot become infected with FMD through contact with 
infected animals or through eating products of diseased animals, still, 
FMD can have economic consequences, as recent outbreaks in the United 
Kingdom have demonstrated. Although estimates vary, experts agree that 
the economic consequences of an FMD outbreak on the U.S. mainland could 
be significant, especially for red meat producers whose animals would 
be at risk for diseases, depending on how and where such an outbreak 
occurred. 

The Economic Impact of the 2001 FMD Outbreak in the United Kingdom: 

According to a study by the U.K. National Audit Office, the direct cost 
of the 2001 FMD outbreak to the public sector was estimated at over 
$5.71 billion and the cost to the private sector was estimated at over 
$9.51 billion.[Footnote 41] By the time the disease was eradicated, in 
September 2001, more than six million animals had been slaughtered: 
over four million for disease control purposes and two million for 
welfare reasons.[Footnote 42] 

Compensation and other payments to farmers were expected to total 
nearly $2.66 billion. Direct costs of measures to deal with the 
epidemic, including the purchase of goods and services to eradicate the 
disease, were expected to amount to nearly $2.47 billion. Other public 
sector costs were estimated at $0.57 billion.[Footnote 43] 

In the private sector, agriculture and the food chain and supporting 
services incurred net costs of $1.14 billion. Tourism and supporting 
industries lost revenues eight times that level--$8.56 billion to 
$10.27 billion, when the movement of people in the countryside was 
restricted. The Treasury had estimated that the net economic effect of 
the outbreak was less than 0.2 percent of gross domestic product, 
equivalent to less than $3.8 billion.[Footnote 44] 

The Potential Impact of an FMD Outbreak in the United States: 

The possibility of the introduction of FMD into the United States is of 
concern because this country has the largest fed-cattle industry in the 
world, and it is the world largest producer of beef, primarily high- 
quality, grain-fed beef for export and domestic use. 

Although estimates of the losses vary, experts agree that the economic 
consequences of an FMD outbreak on the U.S. mainland could mean 
significant losses, especially for red meat producers, whose animals 
would be at risk for disease, depending on how and where an outbreak 
occurred. Current estimates of U.S. livestock inventories are 97 
million cattle and calves, 7 million sheep, and 59 million hogs and 
pigs, all susceptible to an FMD outbreak. The total value of the cash 
receipts for U.S. livestock in 2007 was $141.4 billion. The total 
export value of red meat in 2007 was $6.4 billion. These values 
represent the upper bound of estimated losses. 

Direct costs to the government would include the costs of disease 
control and eradication, such as the maintenance of animal movement 
controls, control areas, and intensified border inspections; the 
destruction and disposal of infected animals; vaccines; and 
compensation to producers for the costs of disease containment. 
However, government compensation programs might not cover 100 percent 
of producers' costs. As a result, direct costs would also occur for 
disinfection and for the value of any slaughtered animals not subject 
to government compensation. 

According to the available studies, the direct costs of controlling and 
eradicating a U.S. outbreak of FMD could vary significantly, depending 
on many factors including the extent of the outbreak and the control 
strategy employed. 

Indirect costs of an FMD outbreak would include costs affecting 
consumers, ancillary agricultural industries, and other sectors of the 
economy. For example, if large numbers of animals were destroyed as 
part of a control and eradication effort, then ancillary industries 
such as meat processing facilities and feed suppliers would be likely 
to lose revenue. 

Furthermore, an FMD outbreak could have adverse effects such as 
unemployment, loss of income (to the extent that government 
compensation would not fully reimburse producers), and decreased 
economic activity, which could ripple through other sectors of the 
economy as well. However, our analyses show that these effects would 
likely be local or regional and limited in scope. 

The economic effects of an FMD outbreak would depend on the 
characteristics of the outbreak and how producers, consumers, and the 
government responded to it. The scale of the outbreak would depend on 
the time elapsed before detection and the number of animals exposed, 
among other factors. Costs to producers of addressing the disease 
outbreak and taking steps to recover would similarly vary. The 
responses of consumers in the domestic market would depend on their 
perceptions of safety, as well as changes in the relative prices of 
substitutes for the affected meat products, as supply adjusted to the 
FMD disruption. In overseas markets, consumers, responses would be 
mediated by the actions their governments would take or not take to 
restrict imports from the United States. Because an overall estimate of 
effects depends heavily on the assumptions made about these variables, 
it is not possible to settle on a single economic assessment of the 
cost to the United States of an FMD outbreak. We have reviewed 
literature that considers but a few of the many possible scenarios in 
order to illustrate cost components and to consider the possible market 
reaction rather than to predict any particular outcome. 

Conclusions: 

DHS believes that modern technology, combined with biosafety practices, 
can provide for a facility's safe operation on the U.S. mainland. Most 
experts we talked with believe that technology has made laboratory 
operations safer over the years. However, accidents, while rare, still 
occur because of human or technical errors. Given the non-zero risk of 
a release from any biocontainment facility, most of the experts we 
spoke with told us that an island location can provide additional 
protection. 

DHS has not conducted any studies to determine whether FMD work can be 
done safely on the mainland. Instead, in proposing to move FMD virus to 
the mainland, DHS relied on a 2002 USDA study that addressed a 
different question. That study does not clearly support the conclusion 
that FMD work can be done safely on the mainland. 

An island location can help prevent the spread of FMD virus along 
terrestrial routes, such as by vehicles splashed with contaminated mud, 
and may also reduce airborne transmission. Historically, the United 
States and other countries as well have seen the benefit of an island 
location, with its combination of remoteness from susceptible species 
and a permanent water barrier. 

Although FMD has no human-health implications, recent outbreaks in the 
United Kingdom have demonstrated its economic consequences. Estimates 
for the United States vary but would depend on the characteristics of 
the outbreak and how producers, consumers, and the government responded 
to it. 

Contacts and Acknowledgments: 

For further information regarding this statement, please contact Nancy 
Kingsbury, Ph.D., at (202) 512-2700 or [email protected], or Sushil K. 
Sharma, Ph.D., Dr.PH, at (202) 512-3460 or [email protected]. Contact 
points for our Offices of Congressional Relations and Public Affairs 
may be found on the last page of this statement. William Carrigg, Jack 
Melling, Penny Pickett, and Elaine Vaurio made key contributions to 
this statement. 

[End of section] 

Footnotes: 

[1] 21 U.S. Code ï¿½113a. 

[2] Public Law 107-296, ï¿½310, 116 Stat. 2135, 2174 (2002), codified at 
6 U.S. Code ï¿½190. 

[3] 6 U.S. Code ï¿½542(b)(3). 

[4] HSPD-9 tasked the Secretary of Agriculture and the Secretary of 
Homeland Security with developing a plan to provide safe, secure, and 
state-of-the-art agriculture biocontainment laboratories that research 
and develop diagnostic capabilities for foreign animal and zoonotic 
diseases. HSPD-9 also tasks 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, with the acceleration and 
expanded development of current and new countermeasures against the 
intentional introduction or natural occurrence of catastrophic animal, 
plant, and zoonotic diseases". "Defense of United States Agriculture 
and Food," Homeland Security Presidential Directive/HSPD-9, The White 
House, Washington, D.C., Jan. 30, 2004, secs. 23 and 24. [hyperlink, 
http://www.whitehouse.gov/news/releases/2004/02/20040203-2.html]. 

[5] Since by law, research on FMD virus is not permitted on the U.S. 
mainland, except by permit, USDA would have to issue DHS a permit if 
NBAF is constructed on the mainland, or the Congress would have to 
waive the statutory provision. 

[6] A zoonotic disease is one that can be transmitted from animals to 
people or, more specifically, that normally exists in animals but that 
can infect humans. 

[7] The study, prepared for USDA by Science Applications International 
Corporation (SAIC), was entitled United States Department of 
Agriculture Biocontainment Feasibility Studies, Study Report: Plum 
Island Animal Disease Center (Washington, D.C.: Aug. 15, 2002), (p. 1). 

[8] A BSL-3 Ag facility is a special type of biosafety laboratory that 
is used with large animals. It employs policies and practices such as 
(1) shower upon exit, (2) blow nose and expectorate to clear nasal and 
throat passages, (3) clean underneath fingernails with nail files, (4) 
scrub hands and arms with soap using a brush, and (5) soak eyeglasses 
in a decontamination solution. 

[9] In the case of Germany, since 1971 the island has been connected to 
the mainland by a causeway. For ecological reasons this has been 
interrupted in late 2007 by construction of a roadbridge so that access 
to the island is still possible. 

[10] Biosafety laboratories are classified by the type of agents used 
in them and the risk those agents pose to personnel, the environment, 
and the community. The Department of Health and Human Services' 
Biosafety in Microbiological and Biomedical Laboratories has four 
biosafety levels, with BSL-4 the highest. The levels include 
combinations of laboratory practices and techniques, safety equipment, 
and facilities that are recommended for laboratories that conduct 
research on potentially dangerous agents and toxins. 

[11] Australia only allows work with inactivated FMD viruses at 
Geelong. 

[12] FMD virus is the prototypic member of the Aphthovirus genus in the 
Picornaviridae family. This picornavirus is the etiologic agent of the 
acute systemic vesicular disease that affects cattle and other animals 
worldwide. 

[13] Horses, dogs, and cats are not susceptible but could spread the 
virus by carrying it on their hair. 

[14] GAO, Foot and Mouth Disease: To Protect U.S. Livestock, USDA Must 
Remain Vigilant and Resolve Outstanding Issues, GAO-02-808 (Washington, 
D.C.: July 26, 2002), p. 12. 

[15] A veterinary biologic is a product used for diagnosing, 
preventing, and treating an animal disease. Such products include 
vaccines and kits for diagnosing specific animal diseases. 

[16] GAO, Plum Island Animal Disease Center: DHS and USDA Are 
Successfully Coordinating Current Work, but Long-Term Plans Are Being 
Assessed, GAO-06-132 (Washington, D.C.: Dec. 19, 2005). 

[17] USDA conducts research on high-priority diseases affecting animals 
besides livestock, such as poultry, at other locations. For example, 
diseases like Newcastle disease and avian influenza, which affect 
poultry, are studied at USDA's Southeast Poultry Research Laboratory in 
Athens, Georgia. USDA's National Animal Disease Center in Ames, Iowa, 
studies indigenous diseases of livestock and poultry, including 
brucellosis. USDA performs diagnostics on these diseases at the 
National Veterinary Services Laboratories in Ames, Iowa. 

[18] There is no universal FMD vaccine that is effective for all 
subtypes of FMD. The United States stockpiles some FMD vaccines at the 
North American Foot-and-Mouth Disease Vaccine Bank on Plum Island. 
However, these vaccines are not stored in a "ready-to-use" state. That 
is, they are stored as a vaccine antigen concentrate that requires 
finishing in order to be used. 

[19] Pub. L. 107-296, ï¿½310, 116 Stat. 2135, 2174 (2002), codified at 6 
U.S. Code ï¿½190. 

[20] 6 U.S. Code ï¿½542(b)(3). 

[21] All federal agencies are required to comply with the National 
Environmental Policy Act, 1142 U.S. Code ï¿½ï¿½ 4321-4347. Under the act, 
agencies evaluate the likely environmental effects of projects that 
could significantly affect the environment. 

[22] The final disposition of the existing PIADC facilities and 
infrastructure, regardless of whether Plum Island is the selected site, 
is not known to us. 

[23] SAIC, United States Department of Agriculture Biocontainment 
Feasibility Studies, Study Report. The study examined a number of other 
questions concerning a possible move of PIADC to the mainland, in 
addition to the questions on technical feasibility regarding biosafety 
and biosecurity. 

[24] Among other things, (1) the study used an ad hoc method to select 
its expert panel that was not necessarily free from bias; (2) the study 
report was written by a single third-party person under contract for 
that purpose who was not present during the panel discussions; and (3) 
no concern was taken to ensure that the expert panel members reviewed 
either the draft or the final version of the report. At least one 
expert panel member expressed disappointment with the slant of the 
report. 

[25] As required by the National Environmental Policy Act, DHS must 
prepare an EIS for each of the six potential NBAF sites. DHS told us 
that each EIS will contain an analysis of site-specific environmental 
consequences, given, among other things, an accidental release of FMD 
at the site. However, DHS would not give us specifics on what this 
analysis will contain or which accident scenarios are being considered. 
DHS told us that the draft EIS for each site is due at the end of May 
2008. 

[26] SAIC, United States Department of Agriculture Biocontainment 
Feasibility Studies, Study Report, p. 16. 

[27] SAIC, United States Department of Agriculture Biocontainment 
Feasibility Studies, Study Report, p. 16. 

[28] SAIC, United States Department of Agriculture Biocontainment 
Feasibility Studies, Study Report, p. ii. 

[29] GAO, High Containment Biosafety Laboratories: Preliminary 
Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 
Laboratories in the United States, GAO-08-108T (Washington, D.C.: Oct. 
4, 2007), pp. 22-23. 

[30] In addition to an increase in the number of large animals being 
processed, the new facility is to house a vaccine production plant with 
a capacity of up to 30 liters--a significant increase in volume of FMD 
virus than is handled at PIADC. 

[31] In some cases, a BSL-3 Ag facility can be placed within another 
containment area for additional protection. 

[32] Institute of Environmental Sciences and Technology, IEST-RP- 
CC001.3 and MIL-STD-282 Method 102.9.1, are typical standards applied 
for HEPA filtration. It has been shown that because of the unique 
design of HEPA filters, they are least efficient around the 0.3 micron 
particle size and the efficiency benchmark of 99.97 is applied at that 
particle size. 

[33] Few, if any, empirical studies examin the true efficiency of HEPA 
filtration against a specific challenge of FMD virus. One expert in 
airborne transmission of FMD virus told us that while it is 
theoretically possible for transmission through HEPA filters to occur, 
to his knowledge there has never been a documented case. 

[34] Australia contracts, for example, with laboratories in Thailand 
for its live FMD research and challenge work. 

[35] The character of the island has changed over time. Whereas in the 
past, it could only be reached by boat or suspended cablecar, since 
1971 it is connected to the mainland by a causeway. For ecological 
reasons this has been interrupted in late 2007 by construction of a 
roadbridge so that access to the island is still possible. 

[36] OIE is the intergovernmental organization responsible for 
improving animal health worldwide. The need to fight animal diseases at 
the global level led to the creation of the Office International des 
Epizooties through an international agreement signed on January 25, 
1924. In May 2003, OIE became the World Organisation for Animal Health 
but kept its identity as OIE. 

[37] The members of the expert panel involved in the 2002 study we 
talked with told us that the advantages of an island location had not 
been extensively considered. Rather, the discussion focused on the 
availability of modern facilities and technology and the fact that they 
can be built anywhere. One expert summarized the discussion by saying 
that the safety risk had been "put to rest" by the availability of 
modern biocontainment facilities. However, we found that the consensus 
that FMD work could be moved safely to the mainland was not unanimous 
among the panel members and that there was at least one member in 
dissension, a fact that was missing from the written report. 

[38] "Final Committee Report: Exploratory Analysis--FMD Outbreak in 
Animal Supply, Memorandum from PIADC Safety Investigation Committee to 
Director J. J. Callis, January 9, 1979. 

[39] GAO-02-808, p. 20. 

[40] The specific geographic features surrounding the release site 
would have to be considered, but speaking generally about the U.S. 
Central Plains, these officials said it would be difficult for the 
United States to retain a disease-free status given a release from a 
facility in such a location. 

[41] Comptroller and Auditor General, The 2001 Outbreak of Foot and 
Mouth Disease (London: National Audit Office, June 21, 2002). 

[42] The 2001 outbreak of FMD spread to France, the Republic of 
Ireland, the Netherlands and Northern Ireland. However, the NAO study 
did not include the cost incurred by these countries. 

[43] We have converted the British pound to 2001 U.S. dollars and then 
we adjusted to current value. 

[44] The total cost to the country was estimated at $30.4 billion at 
current values. 

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