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2007. 

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United States Government Accountability Office: 
GAO: 

Testimony: 

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

For Release on Delivery: 
Expected at 10:00 a.m. EDT: 
Thursday, October 4, 2007: 

High-Containment Biosafety Laboratories: 

Preliminary Observations on the Oversight of the Proliferation of BSL-
3 and BSL-4 Laboratories in the United States: 

Statement of Keith Rhodes: 
Chief Technologist: 
Center for Technology and Engineering: 
Applied Research and Methods: 

GAO-08-108T: 

GAO Highlights: 

Highlights of GAO-08-108T, a testimony before the Subcommittee on 
Oversight and Investigation, Committee on Energy and Commerce, House of 
Representatives. 

Why GAO Did This Study: 

In response to the global spread of emerging infectious diseases and 
the threat of bioterrorism, high-containment biosafety laboratories 
(BSL)--specifically biosafety level (BSL)-3 and 
BSL-4--have been proliferating in the United States. These 
labs—classified by the type of agents used and the risk posed to 
personnel, the environment, and the community—often contain the most 
dangerous infectious disease agents, such as Ebola, smallpox, and avian 
influenza. This testimony addresses (1) the extent to which there has 
been a proliferation of BSL-3 and BSL-4 labs, (2) federal agencies’ 
responsibility for tracking this proliferation and determining the 
associated risks, and (3) the lessons that can be learned from recent 
incidents at three high-containment biosafety labs. To address these 
objectives, GAO asked 12 federal agencies involved with high-
containment labs about their missions and whether they tracked the 
number of labs overall. GAO also reviewed documents from these 
agencies, such as pertinent legislation, regulation, and guidance. 
Finally, GAO interviewed academic experts in microbiological research.

What GAO Found: 

A major proliferation of high-containment BSL-3 and BSL-4 labs is 
taking place in the United States, according to the literature, federal 
agency officials, and experts. The expansion is taking place across 
many sectors—federal, academic, state, and private—and all over the 
United States. Concerning BSL-4 labs, which handle the most dangerous 
agents, the number of these labs has increased from 5—before the 
terrorist attacks of 2001—to 15, including at least 1 in planning 
stage. Information on expansion is available about high-containment 
labs that are registered with the Centers for Disease Control and 
Prevention (CDC) and the U.S. Department of Agriculture’s (USDA) Select 
Agent Program, and that are federally funded. However, much less is 
known about the expansion of labs outside the Select Agent Program, as 
well as the nonfederally funded labs, including location, activities, 
and ownership. 

No single federal agency, according to 12 agencies’ responses to our 
survey, has the mission to track the overall number of BSL-3 and BSL-4 
labs in the United States. Though several agencies have a need to know, 
no one agency knows the number and location of these labs in the United 
States. Consequently, no agency is responsible for determining the 
risks associated with the proliferation of these labs. 

We identified six lessons from three recent incidents: failure to 
report to CDC exposures to select agents by Texas A&M University 
(TAMU); power outage at the CDC’s new BSL-4 lab in Atlanta, Georgia; 
and release of foot-and-mouth disease virus at Pirbright in the United 
Kingdom. These lessons highlight the importance of (1) identifying and 
overcoming barriers to reporting in order to enhance biosafety through 
shared learning from mistakes and to assure the public that accidents 
are examined and contained; (2) training lab staff in general 
biosafety, as well as in specific agents being used in the labs to 
ensure maximum protection; (3) developing mechanisms for informing 
medical providers about all the agents that lab staff work with to 
ensure quick diagnosis and effective treatment; (4) addressing 
confusion over the definition of exposure to aid in the consistency of 
reporting; (5) ensuring that BSL-4 labs’ safety and security measures 
are commensurate with the level of risk these labs present; and (6) 
maintenance of high-containment labs to ensure integrity of physical 
infrastructure over time. 

Table: Summary of Known BSL-4 Labs in the United States by Sector:

Sector:	Federal government; 
Before 1990: 2;	
1990-2000: 1; 
2001-Present: 6; 	
Total: 9. 

Sector:	Academic; 
Before 1990: 0; 	
1990-2000: 1; 
2001-Present: 3; 	
Total: 4. 

Sector:	State; 
Before 1990: 0; 	
1990-2000: 0; 
2001-Present: 1; 	
Total: 1. 

Sector:	Private;	
Before 1990: 0; 
1990-2000: 1; 
2001-Present: 0; 	
Total: 1. 

Sector:	Total; 
Before 1990: 2; 	
1990-2000: 3; 
2001-Present: 10; 	
Total: 15. 

Source: GAO analysis based on open source information.

[End of table] 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://GAO-08-108T]. For more information, contact Keith 
Rhodes at (202) 512-6412 or rhodesk@gao.gov.

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

We are pleased to be here today to discuss our preliminary findings on 
the oversight of the expansion of high-containment biosafety level 
(BSL)-3 and BSL-4 laboratories (labs) in the United States. This 
expansion is, in part, a response to the global spread of emerging 
infectious diseases and the threat of bioterrorism. 

BSL-3 and BSL-4 labs often contain the most dangerous infectious 
disease agents (for example, Ebola, smallpox, avian influenza, and 
severe acute respiratory syndrome [SARS]), including those for which 
effective vaccines or treatment may not be available. Although high-
containment labs are designed to promote the safety of researchers and 
the public, accidents and security breaches have occurred in the past. 
In addition, these labs can be used by terrorists or people with 
malicious intent to acquire or develop harmful biological 
agents,[Footnote 1] posing a severe national security and public health 
threat. 

The intentional dissemination of an agent--anthrax--in the U.S. mail 
demonstrated the devastating effect such agents can have in the wrong 
hands. As a result of exposure to anthrax-tainted mail in the fall of 
2001, 22 individuals contracted anthrax disease in four states--
Connecticut, Florida, New Jersey, and New York--as well as in 
Washington, D.C. Of these 22 individuals, 5 died. 

These anthrax incidents highlighted major gaps in our civilian capacity 
to respond to a biological attack; most noted among them, according to 
the National Institute of Allergy and Infectious Diseases (NIAID), was 
the shortage of high-containment lab capacity available to conduct 
research leading to the development of medical 
countermeasures.[Footnote 2] To address this concern, the 
Administration and Congress responded by providing increased funding 
for biodefense research and for additional BSL-3 and BSL-4 labs in the 
private sector, especially in university settings. 

However, concerns have been raised about the oversight of these labs 
because the deliberate or accidental release of biological agents can 
have disastrous consequences, such as exposing workers and the public. 
In addition, as the number of BSL-3 and BSL-4 labs has been increasing, 
concerns have also been raised about their safety, as well as 
operations. Finally, there are security concerns about the potential 
theft of the material itself. Accordingly, you asked us to address the 
following three questions: 

1. To what extent, and in what areas, has there been an expansion in 
the number of high-containment labs in the United States? 

2. Which federal agency is responsible for tracking the expansion of 
high-containment labs and determining the associated aggregate risks? 

3. What lessons can be learned from recent incidents at three high-
containment labs? 

To answer these questions, we interviewed officials from several 
federal agencies, as well as experts; reviewed literature; conducted 
site visits; and surveyed 12 federal agencies. We conducted our work 
from August 2006 through September 2007 in accordance with generally 
accepted government auditing standards (see appendix I for our scope 
and methodology). 

Background: 

Since September 11, 2001, there has been an increase in the funding for 
research in biomedicine. This increase is intended to develop effective 
medical countermeasures, against emerging infectious diseases and 
biological agents, which can only be performed safely in BSL-3 and BSL-
4 labs. A large part of this funding has been used to construct 
additional high-containment BSL-3 and BSL-4 labs. 

BSL-3 and BSL-4 Labs: 

The BSL labs are classified by the type of agents used and the risk 
posed to personnel, the environment, and the community by those agents. 
The Department of Health and Human Services's (HHS) Biosafety in 
Microbiological and Biomedical Laboratories (BMBL) guidelines specify 
four biosafety levels,[Footnote 3] with BSL-4 being the highest. The 
levels include combinations of laboratory practices and techniques, 
safety equipment, and facilities that are recommended for labs that 
conduct research on potentially dangerous agents and toxins. These labs 
are to be designed, constructed, and operated in a manner to (1) 
prevent accidental release of infectious or hazardous agents within the 
laboratory and (2) protect lab workers and the environment external to 
the lab, including the community, from exposure to the agents. 

Work in BSL-3 labs involves agents that may cause serious and 
potentially lethal infection. In some cases, there are vaccines or 
effective treatments available. Types of agents that are typically 
handled in BSL-3 labs include, for example, anthrax, West Nile Virus, Q 
fever, tularemia, and avian flu. Work in BSL-4 labs involves the most 
dangerous agents for which there are no effective vaccines or 
treatments available. Types of agents that are typically handled in 
BSL-4 labs include, for example, Ebola, hemorrhagic fevers, and 
smallpox.[Footnote 4] 

Federal Agencies and BSL-3 and BSL-4 Labs: 

Many different federal agencies have some connection with BSL-3 and 
BSL-4 labs in the United States. These agencies are involved with these 
labs in various capacities, including as users, owners, regulators, and 
funding sources. For example, the Centers for Disease Control and 
Prevention (CDC) has its own high-containment labs and regulates that 
portion of labs working with select agents and toxins that represent a 
risk to human health and safety. Similarly, the U.S. Department of 
Agriculture (USDA) has its own labs and regulates labs working with 
select agents and toxins posing a risk to animal and plant health. The 
NIAID has its own labs and is a major funding source for construction 
and research involving high-containment labs. The National Institutes 
of Health (NIH) both funds research requiring high containment and 
provides guidance that is widely used to govern many of the activities 
in high-containment labs. The Food and Drug Administration (FDA) has 
its own labs and regulates manufacturing of biological products, some 
of which require high-containment labs. The Department of Commerce 
(DOC) regulates the export of agents and equipment that have both 
military and civilian uses, which are often found in high-containment 
labs. The Department of Defense (DOD) has its own labs and funds 
research requiring high-containment labs. The Department of Labor's 
(DOL) Occupational Safety and Health Administration (OSHA) regulates 
some activities within high-containment labs, as well as general safety 
in most high-containment labs. The Department of State (DOS) regulates 
the export of agents and equipment that are specifically designed for 
military use from defense-related high-containment labs and maintains a 
listing of some high-containment labs, as part of the U.S. commitments 
under the Biological and Toxin Weapons Convention (BWC). The Department 
of Justice's (DOJ) Federal Bureau of Investigation (FBI) uses high-
containment labs when their forensic work involves dangerous biological 
agents. The Department of Homeland Security (DHS) has its own labs and 
funds a variety of research requiring high-containment labs. The 
Department of Energy (DOE) has several BSL-3 labs doing research to 
develop detection and response systems to improve preparedness for 
biological attack. The Department of Interior (DOI) has its own BSL-3 
labs for work with infectious animal diseases. The Department of 
Veterans Affairs (VA) has research and clinical BSL-3 labs for its work 
with veterans. The Environmental Protection Agency (EPA) has its own 
labs and also coordinates use of various academic, state, and 
commercial high-containment labs nationwide, as part of its emergency 
response mission. 

Pertinent Laws and Guidance: 

The pertinent laws and guidance include the following (see appendix II 
for pertinent regulations): 

Pertinent Laws: 

The Antiterrorism and Effective Death Penalty Act of 1996 includes 
provisions to regulate the transfer, between laboratories, of certain 
biological agents and toxins and requires the Secretary of HHS to 
implement these provisions. As part of the implementation of this act, 
the first list of regulated biological agents was created. This became 
known as the select agent list. 

The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002 revised and expanded the Select Agent Program. Among other 
requirements, the new law (1) revised the list of agents deemed "select 
agents," which possess the "potential to pose a severe threat" to 
public health and safety, to animal or plant health, or to animal or 
plant products; (2) directed the Secretaries of HHS and Agriculture to 
biennially review and publish the select agent list, making revisions 
as appropriate to protect the public; (3) required all facilities 
possessing select agents to register with the Secretary of HHS, 
Agriculture, or both, not just those facilities sending or receiving 
select agents; (4) restricted access to biological agents and toxins by 
persons who do not have a legitimate need and who are considered a risk 
by federal law enforcement and intelligence officials; (5) required 
transfer registrations to include information regarding the 
characterization of agents and toxins to facilitate their 
identification, including their source; (6) required the creation of a 
national database with information on all facilities and persons 
possessing, using, or transferring select agents; and (7) required the 
Secretaries of HHS and Agriculture to impose more detailed and 
different levels of security for different select agents, based on 
their assessed level of threat to the public. 

Pertinent Guidance: 

Pertinent guidance includes NIH and CDC BMBL guidance, as well as NIH 
guidelines. 

NIH and CDC BMBL Guidance: 

The NIH and CDC prepared the BMBL as a guidance document for working 
with particular select agents. According to the BMBL guidelines, (1) 
BSL-1 laboratories house agents and toxins that do not consistently 
cause disease in healthy adult humans; (2) BSL-2 laboratories are 
capable of housing agents and toxins that are spread through puncture, 
absorption through mucous membranes, or ingestion of infectious 
materials; (3) BSL-3 laboratories are capable of housing agents and 
toxins that have a potential for aerosol transmission and that may 
cause serious and potentially lethal infection; (4) BSL-4 laboratories 
are capable of housing agents and toxins that pose a high individual 
risk of life-threatening disease, which may be aerosol transmitted and 
for which there is no available vaccine or therapy. 

The BMBL states that (1) biosafety procedures must be incorporated into 
the laboratory's standard operating procedures or biosafety manual; 
(2) personnel must be advised of special hazards and are required to 
read and follow instructions on practices and procedures; and (3) 
personnel must receive training on the potential hazards associated 
with the work involved and the necessary precautions to prevent 
exposure. Further, the BMBL contains guidelines for laboratory security 
and emergency response, such as controlling access to areas where 
select agents are used or stored. The BMBL also states that a plan must 
be in place for informing police, fire, and other emergency responders 
as to the type of biological materials in use in the laboratory areas. 

NIH Guidelines for Research Involving Recombinant DNA Molecules: 

Much of the work in BSL-3 and BSL-4 labs in the United States involves 
recombinant DNA (rDNA), and the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH rDNA Guidelines) set the standards and 
procedures for research involving rDNA. Institutions must follow these 
guidelines when they receive NIH funding for this type of research. The 
guidelines include the requirement to establish an institutional 
biosafety committee (IBC). The IBC is responsible for (1) reviewing 
rDNA research conducted at or sponsored by the institution for 
compliance with the NIH rDNA Guidelines and (2) approving those 
research projects that are found to conform with the NIH rDNA 
Guidelines. IBCs also periodically review ongoing rDNA research to 
ensure continued compliance with the NIH rDNA Guidelines. 

The Select Agent Program: 

The CDC is responsible for the registration and oversight of 
laboratories that possess, use, or transfer select agents and toxins 
that could pose a threat to human health. USDA is responsible for the 
registration and oversight of laboratories that possess, use, or 
transfer select agents and toxins that could pose a threat to animal or 
plant health or animal or plant products. Some select agents, such as 
anthrax, pose a threat to both human and animal health and are 
regulated by both agencies (see appendix III for the list of select 
agents and toxins). 

The select agent regulations require registration for U.S.-based 
research institutions, government agencies, universities, 
manufacturers, and other entities that possess, use, or transfer select 
agents. Registration is for 3 years. As part of the registration 
process, facilities must demonstrate in their applications that they 
meet the recommendations delineated in the BMBL for working with 
particular select agents. Such requirements include having proper 
laboratory and personal protective equipment, precautionary signage, 
and ventilation; controlled access; and biosafety operations manuals. 
Facilities must also describe the laboratory procedures that will be 
used, provide a laboratory floor plan showing where the select agent 
will be handled and stored, and describe how access will be limited to 
authorized personnel. 

In addition, facilities must describe the objectives of the work that 
requires the select agent. Each facility must identify a responsible 
facility official who is authorized to transfer and receive select 
agents on behalf of the facility. Individuals making false, fictitious, 
or fraudulent statements on registration forms may be punished, under 
the False Statements Act, by a fine of up to $250,000, imprisonment up 
to 5 years, or both. Violations by organizations are punishable by a 
fine of up to $500,000 per violation. To ensure compliance with these 
requirements, the program established a goal of inspecting these 
facilities once during the 3-year registration period. Facilities may 
be inspected before and after registration, but there is no requirement 
that inspections be performed. 

Results in Brief: 

A major expansion of high-containment biosafety labs (BSL-3 and BSL-4) 
is taking place in the United States, according to the literature, 
federal agency officials, and experts. Concerning BSL-4 labs, which 
handle the most dangerous agents, the number of these labs has 
increased from 5--before the terrorist attacks of 2001--to 15, 
including at least 1 in the planning stage. The expansion is taking 
place across many sectors--federal, state, academic, and 
private[Footnote 5]--and across most of the United States. Information 
on expansion is available about high-containment labs that are 
(1) registered with the CDC-USDA Select Agent Program and (2) federally 
funded. However, much less is known about the expansion of labs outside 
the Select Agent Program as well as the nonfederally funded labs, 
including location, activities, and ownership. 

No single federal agency has the mission and, therefore, is accountable 
for tracking the number of all BSL-3 and BSL-4 labs within the United 
States. Moreover, although several agencies have a need to know the 
number and location of these labs to support their missions, no agency 
knows how many such labs there are in the United States or their 
locations, according to agencies' responses to our survey. Therefore, 
no agency is responsible for determining the aggregate risks associated 
with the expansion of these labs. According to the experts, there is a 
baseline risk associated with any high-containment lab, attributable to 
human errors. With this expansion, the risk will increase. However, the 
associated safety and security risks will be greater for new labs with 
less experience. 

We identified six lessons from three recent incidents: failure to 
report to CDC exposures to select agents by Texas A&M University 
(TAMU); power outage at CDC's new BSL-4 lab in Atlanta, Georgia; and a 
release of foot-and-mouth disease virus at Pirbright in the United 
Kingdom (U.K.). These lessons highlight the importance of (1) 
identifying and overcoming barriers to reporting in order to enhance 
biosafety through shared learning from mistakes and to assure the 
public that accidents are examined and contained; (2) training lab 
staff in general biosafety, as well as in specific agents being used in 
the labs to ensure maximum protection; (3) developing mechanisms for 
informing medical providers about all the agents that lab staff work 
with to ensure quick diagnosis and effective treatment; (4) addressing 
confusion over the definition of exposure to aid in the consistency of 
reporting; (5) ensuring that BSL-4 labs' safety and security measures 
are commensurate with the level of risk these labs present; and 
(6) maintenance of high-containment labs to ensure integrity of 
physical infrastructure over time. 

Expansion of BSL-3 and BSL-4 Labs Is Taking Place across Many Sectors 
and All over the United States: 

An expansion in the number of BSL-3 and BSL-4 labs is taking place 
across most of the United States,[Footnote 6] according to the 
literature, federal agency officials, and experts. Most federal 
officials and experts believe that the number of BSL-4 labs in the 
United States is generally known. But the number of BSL-3 labs is 
unknown. Information on expansion is available about high-containment 
labs that are (1) registered with the CDC-USDA's Select Agent Program, 
and (2) federally funded. However, much less is known about the 
expansion of labs outside the Select Agent Program and the nonfederally 
funded labs, including location, activities, and ownership. For both 
BLS-3 and BSL-4, the expansion is taking place across many sectors--
federal, state, academic, and private--and all over the United States. 

An Expansion of BSL-3 and BSL-4 Labs Is Taking Place in All Sectors in 
the United States: 

For most of the last 50 years, there were only two sites with BSL-4 
labs in the United States. These were federal labs at the U.S. Army's 
Research Institute for Infectious Diseases (USAMRIID) in Fort Detrick, 
Maryland, and at the CDC in Atlanta, Georgia. Between 1990 and 2000, 
three new BSL-4 labs were built: a BSL-4 lab at Georgia State 
University in Atlanta--the first BSL-4 lab in a university setting; a 
small BSL-4 lab on the NIH campus in Bethesda, Maryland;[Footnote 7] 
and a privately funded BSL-4 lab in San Antonio, Texas. Since the 
terror attacks of 2001, nine new facilities and one major remodeling 
effort containing BSL-4 space will either be operational, in 
construction, or in planning by this year's end. The number of BSL-4 
laboratories has increased from 5, before 2001, to 15, including at 
least 1 in planning. 

Moreover, expansion is taking place across all sectors. Before 1990, 
all BSL-4 labs were federal labs--either at USAMRIID or at the CDC. 
Today, while expansion is taking place within the federal sector as 
well--there are seven new federal facilities recently built, currently 
under construction, or planned, which have one or more BSL-4 labs--
there are also BSL-4 labs at universities, as part of state response, 
and in the private sector. (See table 1 for expansion in BSL-4 labs by 
sector.) 

Table 1: Summary of Known BSL-4 Labs in the United States, by Sector:

Sector:	Federal government; 
Before 1990: 2;	
1990-2000: 1; 	
2001-Present: 6; 	
Total: 9. 

Sector:	Academic; 
Before 1990: 0; 	
1990-2000: 1; 
2001-Present: 3; 	
Total: 4. 

Sector:	State; 
Before 1990: 0; 	
1990-2000: 0; 
2001-Present: 1; 	
Total: 1. 

Sector:	Private;	
Before 1990: 0; 
1990-2000: 1; 
2001-Present: 0; 	
Total: 1. 

Sector:	Total; 
Before 1990: 2; 	
1990-2000: 3; 
2001-Present: 10; 	
Total: 15. 

Source: GAO analysis based on open source information. 

Note: These numbers represent the lower bound of the number of BSL-4 
labs. Within each of these facilities, there may be several independent 
rooms designated as work areas, each at BSL-4 level. 

[End of table] 

While the number is difficult to quantify, many more BSL-3 labs are 
thought to exist compared with BSL-4 labs. Many lab owners--when 
building new labs or upgrading existing ones--are building to meet BSL-
3 level containment, often anticipating future work, even though they 
intend for some time to operate at the BSL-2 level with BSL-2 
recommended agents. In addition, much biodefense work, for example, 
involves aerosolization of agents for challenge studies, and most of 
this type of activity is often recommended for containment at the BSL-
3 level. 

The expansion of BSL-3 labs is in all sectors. However, the only 
definitive data available are on labs registered with the CDC-USDA 
Select Agent Program. Within that program, two-thirds of registered 
BSL-3 labs are outside the federal sector (see table 2).

Table 2: BSL-3 Labs Registered with the CDC and USDA Select Agent 
Program, by Sector: 

Sector: Federal; 
CDC-registered labs: Number: 291; 
USDA-registered labs: Number: 167; 
Total: Number: 458.

Sector: Academic; 
CDC-registered labs: Number: 429; 
USDA-registered labs: Number: 58; 
Total: Number: 487.

Sector: State; 
CDC-registered labs: Number: 248; 
USDA-registered labs: Number: 20; 
Total: Number: 268.

Sector: Private; 
CDC-registered labs: Number: 74; 
USDA-registered labs: Number: 69; 
Total: Number: 143.

Sector: Total; 
CDC-registered labs: Number: 1042; 
USDA-registered labs: Number: 314; 
Total: Number: 1356.

Source: GAO's analysis of CDC-USDA data. 

[End of table] 

Within the academic sector, for example, NIAID has provided funding for 
13 Regional Biocontainment Laboratories (RBL) to provide regional BSL-
3 capability for academic research requiring such containment. 
Expansion at the state level is also taking place (see table 3). 
According to a survey conducted by the Association of Public Health 
Laboratories (APHL) in August 2004, since 2001 state public health labs 
have used public health preparedness funding to build, expand, and 
enhance BSL-3 labs.[Footnote 8] In 1998, for example, APHL found that 
12 of 38 responding states reported having a state public health 
laboratory at the BSL-3 level. Today, at least 46 states have at least 
one state public health BSL-3 lab. 

Table 3: BSL-3 Labs in the State Public Health System: 

Calendar year: 2001; 
State public health BSL-3 labs: 69.

Calendar year: 2002; 
State public health BSL-3 labs:71.

Calendar year: 2003; 
State public health BSL-3 labs:139.

Source: Association of Public Health Laboratories, 2005.

[End of table] 

The Expansion of BSL-3 and BSL-4 Labs Is Taking Place Generally across 
the United States: 

Expansion of BSL-3 and BSL-4 labs is starting to take place 
geographically as well as by sector. For example, before 1990, BSL-4 
labs were clustered at either USAMRIID at Fort Detrick or at CDC. 
Today, there are BSL-4 labs built, under construction, or in planning 
in four states other than Maryland and Georgia. 

The expansion of BSL-3 labs is widespread across most states. Because 
of the need for individual state response to bioterrorist threats, most 
states now have some level of BSL-3 capacity--at least for diagnostic 
and analytical services--in support of emergency response. In addition, 
within the academic research community, the RBLs being constructed by 
the NIAID are intended to provide regional BSL-3 laboratory capacity to 
support NIAID's Regional Centers of Excellence for Biodefense and 
Emerging Infectious Diseases Research (RCE). Hence, the RBLs are 
distributed regionally around the country. Operational, under 
construction, or currently planned BSL-4 labs and some of the major 
BSL-3 facilities in the United States are shown in figure 1. 

Figure 1: Known BSL-4 Labs and Some of the Major BSL-3 Labs in the 
United States: 

[See PDF for image] 

[End of figure] 

No Federal Agency Has the Mission to Track High-Containment Labs in the 
United States: 

No single federal agency has the mission to track and determine the 
risk associated with the expansion of BSL-3 and BSL-4 labs in the 
United States, and no single federal agency knows how many such labs 
there are in the United States. Consequently, no one is responsible for 
determining the aggregate risks associated with the expansion of these 
high-containment labs. 

None of the federal agencies that responded to our survey indicated 
that they have the mission to track and know the number of BSL-3 and 
BSL-4 labs within the United States (see table 4). 

Table 4: Federal Agencies' Mission to Track and Know the Number of All 
BSL-3 and BSL-4 Labs within the United States: 

Agency: Department of Commerce; 
Mission to track: No; 
Know the number: No.

Agency: Department of Defense; 
Mission to track: No; 
Know the number: No.

Agency: Department of Energy; 
Mission to track: No; 
Know the number: No.

Agency: Department of Health and Human Services; 
Mission to track: No; 
Know the number: No.

Agency: Department of Homeland Security; 
Mission to track: No; 
Know the number: No.

Agency: Department of Interior; 
Mission to track: No; 
Know the number: No.

Agency: Department of Justice; 
Mission to track: No; 
Know the number: No.

Agency: Department of Labor; 
Mission to track: No; 
Know the number: No.

Agency: Department of State; 
Mission to track: No; 
Know the number: No.

Agency: Department of Veterans Affairs; 
Mission to track: No; 
Know the number: No.

Agency: Environmental Protection Agency; 
Mission to track: No; Know the number: No.

Agency: U.S. Department of Agriculture; 
Mission to track: No; 
Know the number: No.

Source: GAO Survey of Federal Agencies Involved with BSL-3 and BSL-4 
Labs, 2007.

[End of table] 

Some federal agencies do have a narrow mission to track a subset of 
BSL-3 and BSL-4 labs, and they do know the number of those labs. For 
example, the CDC and USDA together know the number of high-containment 
labs working with select agents because, by federal regulation, such 
labs are required to register with them. But these regulations only 
require that the entities registering with the Select Agent Program do 
a risk assessment of their individual labs. No agency, therefore, has 
the mission to determine the aggregate risks associated with the 
expansion of high-containment labs that work with select agents. 
According to the federal agency officials, the oversight of these labs 
is fragmented and relies on self-policing. 

While the number and location of all BSL-3 and BSL-4 labs is not known, 
several federal agencies indicated that they have a need to know this 
information in support of their agency missions. Some intelligence 
agencies, for example, indicated that they need to know a subset of the 
number and location of high-containment labs within the United States 
because these labs represent a capability that can be misused by 
terrorists or people with malicious intent.[Footnote 9] Without 
knowledge of the number and location of the BSL-3 and BSL-4 labs, some 
agencies' work is made more difficult. For example, the FBI has a need 
to know the number and location of BSL-3 and BSL-4 labs for forensic 
purposes. Without this information, the FBI's work is made more 
difficult. 

According to the experts, there is a baseline risk associated with any 
high-containment. With expansion, the aggregate risks will increase. 
However, the associated safety and security risks will be greater for 
new labs with less experience. In addition, high-containment labs have 
health risks for individual lab workers as well as the surrounding 
community. According to a CDC official, the risks due to accidental 
exposure or release can never be completely eliminated, and even labs 
within sophisticated biological research programs--including those 
most extensively regulated--have had and will continue to have safety 
failures. In addition, while some of the most dangerous agents are 
regulated under the CDC-USDA's Select Agent Program, many high-
containment labs work with agents not covered under this program. Labs 
outside the Select Agent Program also pose risks, given that many 
unregulated agents can cause severe illness or even death (see appendix 
IV for a list of some agents, but not select agents, recommended to be 
worked on in high-containment labs). These labs also have associated 
risks because of their potential as targets for terrorism or theft from 
either external or internal sources. Even labs outside the Select Agent 
Program can pose security risks in that such labs represent a 
capability that can be paired with the necessary agents to become a 
threat. While the United States has regulations governing select 
agents, many nations do not have any regulations governing the transfer 
or possession of dangerous biological agents. 

Lessons Learned from Three Recent Incidents Highlight the Risks 
Inherent in the Expansion of High-Containment Labs: 

We identified six lessons from three recent incidents: failure to 
report to CDC exposures to select agents, in 2006, by TAMU (see 
appendix V); power outage at CDC's new BSL-4 lab, in 2007; and the 
release of foot-and-mouth disease virus, in 2007, at Pirbright, the 
U.K. These lessons highlight the importance of (1) identifying and 
overcoming barriers to reporting in order to enhance biosafety through 
shared learning from mistakes and to assure the public that accidents 
are examined and contained; (2) training lab staff in general biosafety 
as well as in specific agents being used in the labs to ensure maximum 
protection; (3) developing mechanisms for informing medical providers 
about all the agents that lab staff work with to ensure quick diagnosis 
and effective treatment; (4) addressing confusion over the definition 
of exposure to aid in the consistency of reporting; (5) ensuring that 
BSL-4 labs' safety and security measures are commensurate with the 
level of risk these labs present; and (6) maintenance of high-
containment labs to ensure integrity of physical infrastructure over 
time. 

Identifying and Overcoming Barriers to Reporting: 

While the Select Agent Program and the rDNA Guidelines have reporting 
requirements, institutions sometimes fail to report incidents. 
According to CDC, there were three specific types of incidents that 
TAMU officials failed to report to CDC: (1) multiple incidents of 
exposure, including illness; (2) specific types of experiments being 
conducted by researchers; and (3) missing vials and animals. 

In addition, in November 2006, during our first visit to TAMU--a 
meeting in which all key officials who knew about these incidents were 
present--we asked if there had been any incident in which a lab worker 
was exposed to a select agent. TAMU officials did not disclose any of 
these incidents. Moreover, in August 2007, during our second visit, the 
biosafety officer said that he had conducted an investigation of the 
incident, in which the lab worker was exposed to Brucella, and wrote a 
report. However, the report that was provided to us was dated June 17, 
2006, but discussed other incidents that had occurred in 2007, a 
discrepancy that TAMU failed to explain to us.[Footnote 10] 

According to the literature and discussion with federal officials and 
experts, accidents in labs are expected, mostly as a result of human 
error due to carelessness, inadequate training, or poor judgment. In 
the case of theft, loss, occupational exposure, or release of the 
select agent, the lab must immediately report certain information to 
CDC or USDA. However, there is a paucity of information on barriers to 
reporting by institutions. It has been suggested that there is a 
disincentive to report acquired infections and other mishaps at 
research institutions because of (1) negative publicity for the 
institution or (2) the scrutiny from a granting agency, which might 
result in the suspension of research or an adverse effect on future 
funding.[Footnote 11] Further, it is generally believed that when a 
worker acquires an infection in the lab, it is almost always his or her 
fault, and neither the worker nor the lab is interested in negative 
publicity. 

In order to enhance reporting, barriers need to be identified and 
targeted strategies need to be applied to remove those barriers. It is 
also important that these incidents be analyzed so (1) biosafety can be 
enhanced through shared learning from mistakes and (2) the public may 
be reassured that accidents are thoroughly examined and contained. One 
possible mechanism for analysis, discussed in the literature, is the 
reporting system used for aviation incidents, administered by the 
National Transportation Safety Board and the Federal Aviation 
Administration.[Footnote 12] When mistakes are made, they are analyzed 
and learned from without being attributed to any one individual. 
Experts have agreed that some form of personal anonymity would 
encourage reporting. 

Training Lab Staff in General Biosafety, as well as in Specific Agents 
Being Used in the Labs: 

Training is a key requisite for safe and secure work with dangerous 
agents. Moreover, it is important that this training is specific to the 
agent to be worked with and activities to be performed. 

The lab worker at TAMU who was exposed was not authorized to work with 
Brucella but was, we were told, being escorted in the lab only to help 
out with the operating of the aerosolization chamber.[Footnote 13] 
According to the select agent regulations, all staff are required to be 
trained in the specifics of any agent before they work with it. 
However, the worker did not receive training in the specifics of 
Brucella, including its characteristics, safe handling procedures, and 
potential health effects. While the worker was experienced in general 
BSL-3 procedures, her normal work regimen involved working with 
Mycobacterium tuberculosis, and her supervisor surmised that the 
differential potential for infection from Brucella was partially to 
blame for the exposure.[Footnote 14] 

In particular, the exposed lab worker was highly experienced in 
handling M. tuberculosis, an infectious agent. A lab director of a BSL-
2 lab for the last 5 years, she had a PhD in medical sciences and was, 
by many accounts, highly competent and reliable. She had applied the 
procedures governing safe work with M. tuberculosis to the Brucella 
experiment. However, her experience with M. tuberculosis might have 
provided a false sense of security. 

Had training been given in Brucella, the worker might have been more 
aware when cleaning the aerosol chamber. Typical routes of infection 
differ between M. tuberculosis and Brucella and normal procedures, 
including gowning and respiratory equipment, vary between the two 
agents. For example, the lab worker wore protective glasses, but they 
were not tight fitting. This was adequate when working with M. 
tuberculosis, but not with Brucella. The investigation concluded that 
the agent entered the lab worker through the eyes. 

According to one expert who has managed high-containment labs, there 
are risks working alternately in BSL-2 and BSL-3 labs, with their 
different levels of procedures and practices. The fear is that lab 
workers may develop a routine with BSL-2 procedures that might be 
difficult to consciously break when working with the more dangerous 
agents and activities requiring BSL-3 containment. 

Developing Mechanisms for Informing Medical Providers about All the 
Agents that Lab Staff Work with: 

Severe consequences for the worker can result from delays in 
(1) recognizing when an exposure has occurred or (2) medical providers' 
accurately diagnosing any resulting infection. Further, if the worker 
acquires a disease that is easily spread through contact, there can 
also be severe consequences for the surrounding community. 

In the Brucella incident at TAMU, at the time of the exposure on 
February 9, 2006, the lab worker did not know she was infected nor did 
anyone else in the lab. In fact, the CDC conducted a routine inspection 
of TAMU on February 22, 2006--13 days after the exposure--but had no 
way of knowing that it had happened. According to the exposed worker, 
it was more than 6 weeks after the exposure that she first fell ill. 
Then, the first consultation with her physician indicated that she had 
the flu; it was only after the symptoms persisted that a consultation 
with an infectious disease specialist confirmed that her blood 
contained an unknown microorganism. It was at this point that she 
recalled her work with Brucella weeks earlier. Confirmation of 
infection with brucellosis was made on April 16, 2006, by the Texas 
State Public Health Lab--62 days after the exposure. During much of 
this time, the worker had resumed her normal activities, interacting 
with many people. 

In fact, the exposed lab worker had become seriously ill and the delay 
in recognizing her infection as brucellosis aggravated her condition. 
Such misdiagnosis is not uncommon with infectious diseases, as the 
initial symptoms often appear flu-like and brucellosis is not generally 
endemic in the population. If the worker had not recalled the 
experiment with Brucella and alerted her physician to this fact, 
according to the CDC, she might have developed an even more severe 
infection, possibly affecting her central nervous system or the lining 
of her heart. 

In this incident, it was also fortunate that the disease was such that 
transmission beyond the initial exposed individual was difficult and 
that there were no risk of spread to the surrounding community. While 
brucellosis is not easily transferred between humans, many agents cause 
diseases that are easily transferred from human to human through 
coughing or fluid transfer, including some agents that are not select 
agents, such as SARS and tuberculosis. 

According to BMBL, the causative incident for most laboratory-acquired 
infections is often unknown. It can only be concluded that an exposure 
took place after a worker reports illness--with symptoms suggestive of 
a disease caused by the relevant agent--some time later. Since clinical 
symptoms can take weeks to become apparent, during which time an 
infected person may be contagious, it is important that exposure be 
identified as soon as possible and proper diagnosis and prompt medical 
treatment provided. 

Addressing Confusion over the Definition of Exposure: 

In addition to the incident of exposure to Brucella, the CDC noted 
several incidents of potential exposure to Coxiella burnetii that TAMU 
had failed to report. While the Brucella exposure eventually became 
apparent because of clinical symptoms in the lab worker, the C. 
burnetii incidents illustrate situations where the determination of 
exposure can be more problematic. In attempting to address the failure 
to report, questions were raised about what constitutes sufficient 
evidence of an exposure that the entity must report to the CDC. 

One indication of exposure that can be used for C. burnetii and other 
agents is to periodically measure the titer levels--antibody levels--
within the blood serum of lab workers working with those agents. If a 
person has a raised level over his or her baseline level, then a 
conclusion can be drawn that the person has been exposed to the agent. 
However, there are issues with using titer levels as an indication of 
exposure. For example, determining when the exposure took place is not 
straightforward. 

TAMU has a program of monitoring blood serum for workers with 
C. burnetii--a select agent and the causative agent for Q fever in 
humans. While humans are very susceptible to Q fever, only about one-
half of all people infected with C. burnetii show signs of clinical 
illness. During the CDC inspection, triggered by the uncovering of the 
Brucella incident, CDC came across clinical records that showed that 
several lab workers were found to have elevated titers for C. burnetii. 
But no reports had been sent to the CDC. The CDC noted this issue and, 
on April 24, 2007, TAMU submitted the required Form 3 to report the 
possible exposure. 

However, as a result of subsequent discussion with the individuals who 
had the elevated titers, TAMU officials began to have doubts about 
whether or not the elevated titers resulted from exposures that had 
occurred at TAMU. In one case, TAMU said, one of the infected lab 
workers had only recently been hired by TAMU but had worked in a 
clinical lab in China, where C. burnetii was known to have been 
present. In another, the worker claimed to have been exposed many years 
earlier and had always registered high, although the actual levels 
varied. CDC officials disagree with this interpretation and believe the 
high titers resulted from exposures at TAMU. 

TAMU initially responded to the uncovering of the elevated titer 
incidents by reporting, to the CDC, any subsequent elevated titer level 
uncovered in any of their lab workers. But TAMU is now unsure how to 
proceed. It has notified the CDC that, in its opinion, an exposure 
suggested by an elevated titer should be defined to have occurred only 
after clinical symptoms appear in the individual. TAMU has, therefore, 
ceased reporting incidents of merely elevated titers. In the absence of 
clarity over the definition of exposure, TAMU officials have chosen to 
define it as they see fit. 

When we asked the CDC about the confusion over the definition of an 
exposure, officials agreed that terms need to be clearly defined and 
are drafting new guidance. CDC officials noted, however, that it is 
unwise to wait until clinical symptoms appear before determining that 
an exposure has taken place, as this could potentially endanger a 
worker's life and potentially, in the case of a communicable disease, 
others. 

Experts have told us that correctly interpreting the meaning of 
elevated titers--whose characteristics can vary by agent, host, and 
testing lab--is challenging since many serological testing methods have 
not been validated. Gaps in the scientific understanding of infectious 
diseases--such as the meaning of elevated titers--may become more 
problematic as the expansion of labs continues. The development of 
scientifically sound and standardized methods of identifying exposure 
is critical, so that individual lab owners are not left to determine 
for themselves what is and what is not reportable. 

Ensuring that BSL-4 Labs' Safety and Security Measures Are Commensurate 
with the Level of Risk These Labs Present: 

An hour-long power outage, in June 2007, at the CDC's newest BSL-4 
facility raised questions about safety and security, as well as the 
backup power system design. The incident showed that, even in the hands 
of experienced owners and operators, safety and security of high-
containment labs can still be compromised. The incident also raises 
concerns about the security of other similar labs being built around 
the nation. 

On June 8, 2007, the CDC campus in Atlanta experienced lightning 
strikes in and around its new BSL-4 facility, and both primary and 
backup power to that facility were unavailable. The facility was left 
with only battery power--a condition that provides limited power for 
functions such as emergency lighting to aid in evacuation. Among other 
things, the outage shut down the negative air pressure system, one of 
the important components in place to keep dangerous agents from 
escaping the containment areas. In looking into the power outage, the 
CDC determined that, some time earlier, a critical grounding cable 
buried in the ground outside the building had been cut by construction 
workers digging at an adjacent site. The cutting of the grounding 
cable, which had gone unnoticed by CDC facility managers, compromised 
the electrical system of the facility that housed the BSL-4 
lab.[Footnote 15] 

According to CDC officials, the new BSL-4 facility is still in 
preparation to become fully operational and no live agents were inside 
the facility at the time of the power outage. However, given that the 
cable was cut, it is apparent that the construction was not supervised 
to ensure the integrity of necessary safeguards that had been put in 
place. 

Further, according to CDC officials, it was not standard procedure to 
monitor the integrity of the electrical grounding of the new BSL-4 
facility. However, CDC has now instituted annual testing of the 
electrical grounding system. 

Because of the power outage incident, questions about the design of the 
backup power system for the new facility resurfaced. When the CDC 
designed the backup power system for the new BSL-4 facility, it used 
backup generators at a central utility plant which serve other 
facilities, as well as functions such as chillers, on campus besides 
the new BSL-4 facility. According to internal documents provided to us, 
during design phase for the facility, some CDC engineers had questioned 
the remotely placed, integrated design rather than a simpler design 
using local backup generators near the facility. 

According to CDC facility officials, the full backup power capabilities 
for the new BSL-4 facility are not in place yet, but are awaiting 
completion of other construction projects on campus. Once these 
projects are completed, these officials said, the new BSL-4 facility 
will have multiple levels of backup power, including the ability to get 
power from a second central utility plant on campus, if needed. But 
some CDC engineers that we talked to questioned the degree of 
complexity in the design. They are worried that an overly integrated 
backup might be more susceptible to failure. As a result of this power 
outage incident, CDC officials said, the CDC is doing a reliability 
assessment for the entire campus power system, which will include the 
backup power design for the new BSL-4 facility. 

Some experts have suggested that BSL-4 labs be similar in design to a 
nuclear power plant, with a redundant backup-to-backup power system, 
along with adequate oversight. Like such plants, BSL-4 labs are 
considered targets for terrorists and people with malicious intent. 
Release of an agent from any of these labs could have devastating 
consequences. Therefore, appropriate design of labs and adequate 
oversight of any nearby activities--such as adjacent construction with 
its potential to compromise buried utilities--are essential. 

Maintenance of High-Containment Labs: 

High-containment labs are highly sophisticated facilities, which 
require specialized expertise to design, construct, operate, and 
maintain. Because these facilities 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--could have severe consequences. 
Supporting infrastructure, such as drainage and waste treatment 
systems, must also be secure. 

In August 2007, contamination of foot-and-mouth disease was discovered 
at several local farms near Pirbright in the U.K., the site of several 
high-containment labs that work with live foot-and-mouth disease virus. 
Foot-and-mouth disease is one of the most highly infectious livestock 
diseases and can have devastating economic consequences. For example, a 
2001 epidemic in the U.K. cost taxpayers over £3 billion, including 
some £1.4 billion paid in compensation for culled animals.[Footnote 16] 
Therefore, the U.K. government officials worked quickly to contain and 
investigate this recent incident. 

The investigation of the physical infrastructure at the Pirbright site 
found evidence of long-term damage and leakage of the drainage system 
servicing the site, including cracked and leaky pipes, displaced 
joints, debris buildup, and tree root ingress. While the definitive 
cause of the release has not been determined, it is suspected that 
contaminated waste water from Pirbright's labs leaked into the 
surrounding soil from the deteriorated drainage pipes and that live 
virus was then carried offsite by vehicles splashed with contaminated 
mud. 

The cracked and leaky pipes found at Pirbright are indicative of poor 
maintenance practice at the site. The investigation found that 
(1) monitoring and testing for the preventative maintenance of pipework 
for the drainage system was not a regular practice on site and (2) the 
investigation found that a contributing factor might have been a 
difference of opinion over responsibilities for maintenance of a key 
pipe within the drainage system. 

High-containment labs are expensive to build and expensive to maintain. 
Adequate funding for each stage needs to be addressed. Typically, in 
large-scale construction projects, funding for initial construction 
comes from one source. But funding for ongoing operations and 
maintenance comes from somewhere else. For example, in the NIAID's 
recent funding of the 13 BSL-3 labs as RBLs and 2 BSL-4 labs as 
National Biocontainment Labs (NBL), the NIAID contributed to the 
initial costs for planning, design, construction, and commissioning. 
But the NIAID did not provide funding to support the operation of these 
facilities. In this case, the universities themselves are responsible 
for funding any maintenance costs after initial construction. 

The Pirbright incident shows that beyond initial design and 
construction, ongoing maintenance plays a critical role in ensuring 
that high-containment labs operate safely and securely over time. 
Because even the smallest of defects can affect safety, ensuring the 
continuing structural integrity of high-containment labs is an 
essential recurring activity. 

Concluding Observations: 

The expansion of BSL-3 and BSL-4 labs taking place in the United States 
is proceeding in a decentralized fashion, without specific requirements 
as to the number, location, activity, and ownership of such labs. While 
some expansion may be justified to address deficiencies in lab capacity 
for the development of medical countermeasures, unwarranted expansion 
without adequate oversight is proliferation, not expansion. Since the 
full extent of the expansion is not known, it is unclear how the 
federal government can ensure that sufficient but not superfluous 
capacity--that brings with it additional, unnecessary risk--is being 
created. 

The limited federal oversight that does exist for high-containment labs 
is fragmented among different federal agencies, and for the most part 
relies on self-policing. The inherent weaknesses of an oversight system 
based on self-policing are highlighted by the Texas A&M University 
case. While CDC inspected the labs at Texas A&M in April 2006, as part 
of its routine inspection, its inspectors failed to identify that (1) a 
worker became exposed and ill; (2) unauthorized experiments were being 
conducted and unauthorized individuals were entering the labs; and (3) 
agents and infected animals were missing. It was not until a public 
advocacy group found out about the Brucella incident and, according to 
this group, applied pressure--by demanding records about the incident-
-that TAMU reported this incident to the CDC. This report prompted the 
subsequent in-depth investigations by the CDC. 

However, this incident raises serious concerns about (1) how well the 
CDC polices select agent research being conducted in over 400 high-
containment labs at various universities around the country, which are 
registered under the Select Agent Program, and (2) whether the safety 
of the public is compromised. Moreover, if similar safety breaches are 
occurring at other labs, they are not being reported. And the CDC is 
not finding them either. According to the experts, no one knows whether 
the Texas A&M incidents are the tip of the iceberg or the iceberg. 

Mr. Chairman, this concludes my prepared remarks. I would be happy to 
respond to any questions that you or other members of the subcommittee 
may have at this time. 

Contacts and Acknowledgments: 

For further information regarding this statement, please contact Keith 
Rhodes, at (202) 512-6412 or rhodesk@gao.gov, or Sushil K. Sharma, 
Ph.D., Dr.PH, at (202) 512-3460 or sharmas@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this statement. William Carrigg, Jeff McDermott, 
Jean McSween, Jack Melling, Laurel Rabin, Corey Scherrer, Rebecca Shea, 
and Elaine Vaurio made key contributions to this statement. 

[End of section] 

Appendix I: Scope and Methodology: 

To determine the extent of expansion in the number of high-containment 
facilities and the areas experiencing the growth, we interviewed agency 
officials and experts, as well as reviewed documents provided by 
agencies and the literature. 

To determine which federal agency has the mission to track and 
determine the aggregate risks associated with the proliferation of BSL-
3 and BSL-4 labs in the United States, we surveyed 12 federal agencies 
that are involved with BSL-3 or BSL-4 labs in some capacity--for 
example, research, oversight, or monitoring. The survey requested 
information on the agency's involvement with high-containment labs--
specifically, whether the agency has a mission to track the number of 
high-containment labs, whether it has a need to know, and whether it 
knows the number of operating BSL-3 and BSL-4 labs. The agencies that 
received our survey include the U.S. Department of Agriculture (USDA); 
the Department of Commerce; the Department of Defense; the Department 
of Energy; the Environmental Protection Agency; the Department of 
Health and Human Services (HHS), including the Centers for Disease 
Control and Prevention (CDC); the Department of Homeland Security; the 
Department of Interior; the Department of Justice, including the 
Federal Bureau of Investigation (FBI); the Department of Labor, 
including Occupational Safety and Health Administration (OSHA); and the 
Department of States. In addition, we sent our survey to intelligence 
agencies, including the Central Intelligence Agency (CIA), the National 
Counter-Terrorism Center (NCTC); the Defense Intelligence Agency (DIA); 
and the Office of Intelligence Analysis within DHS. We also met with 
officials of the Select Agent Program at both the CDC and the USDA to 
gain additional information about the expansion of high-containment 
labs. Finally, we reviewed documents these agencies provided, including 
pertinent legislation, regulation, and guidance, and reviewed 
scientific literature on risks associated with high-containment labs. 

To develop lessons learned from recent incidents at three high-
containment labs, we interviewed academic experts in microbiological 
research involving human, animal, and plant pathogens, and conducted 
site visits at selected federal, civilian, military, academic, and 
commercial BSL-3 and BSL-4 labs, including the sites involved in the 
recent incidents. Specifically, we conducted site visits to the CDC and 
Texas A&M University (TAMU); talked to the U.K. officials at Health 
Safety Executive and the Department for Environment, Food, and Rural 
Affairs; and reviewed documents and inspection reports. 

To discuss the incidents at TAMU and the CDC, we conducted site visits 
and interviewed the relevant officials. We also conducted a site visit 
to the CDC and interviewed relevant officials, including the officials 
of CUH2A, Inc.--the contractor who designed the backup power system for 
the new BSL-4 lab in Atlanta--as well as the expert hired by this firm 
to conduct the reliability study for the backup power system. 

We conducted our work from August 2006 through September 2007 in 
accordance with generally accepted government auditing standards: 

[End of section] 

Appendix II: Pertinent Regulations: 

The regulations governing the Select Agent Program became effective on 
April 15, 1997, and were revised in March 2005. The regulations include 
six primary components: (1) a list of select agents that have the 
potential to pose a severe threat to public health and safety; (2) 
registration of facilities before the domestic transfer of select 
agents; (3) a process to document successful transfer of agents; (4) 
audit, quality control, and accountability mechanisms; (5) agent 
disposal requirements; and (6) research and clinical exemptions. 

For facilities registered with the CDC and the USDA that possess, use, 
or transfer select agents, the select agent regulations require (1) an 
FBI security risk assessment for a number of individuals, including 
each person who is authorized to have access to select agents and 
toxins; (2) written biosafety and incident response plans; (3) training 
of individuals with access to select agents and of individuals who will 
work in or visit areas where select agents or toxins are handled and 
stored; (4) a security plan sufficient to safeguard the select agent or 
toxin against unauthorized access, theft, loss, or release, and 
designed according to a site-specific risk assessment that provides 
protection in accordance with the risk of the agent or toxin; (5) 
possible inspection by the CDC or USDA of the facility and its records 
before issuance of the certificate of registration; (6) maintenance of 
records relating to the activities covered by the select agent 
regulations; and (7) facility registration with the CDC or the USDA 
that indicates (a) each select agent that the entity intends to 
possess, use, or transfer; (b) the building where the agent will be 
used and stored; (c) the laboratory safety level; (d) a list of people 
authorized to have access to each select agent; (e) the objectives of 
the work for each select agent, including a description of the 
methodologies or laboratory procedures to be used; (f) a description of 
the physical security and biosafety plans; and (g) assurance of 
security and biosafety training for individuals who have access to 
areas where select agents are handled and stored. 

[End of section] 

Appendix III: The Select Agents and Toxins List: 

HHS Select Agents and Toxins: 

Abrin; 
Cercopithecine herpesvirus 1 (Herpes B virus); 
Coccidioides posadasii; 
Conotoxins; 
Crimean-Congo haemorrhagic fever virus; 
Diacetoxyscirpenol; 
Ebola virus; 
Lassa fever virus; 
Marburg virus; 
Monkeypox virus; 
Reconstructed 1918 influenza virus[Footnote 17]; 
Ricin 
Rickettsia prowazekii; 
Rickettsia rickettsii; 
Saxitoxin; 
Shiga-like ribosome inactivating proteins;
South American Haemorrhagic Fever viruses: 
- Flexal; 
- Guanarito; 
- Junin; 
- Machupo; 
- Sabia; 
Tetrodotoxin; 
Tick-borne encephalitis complex (flavi) viruses: 
- Central European Tick-borne encephalitis; 
- Far Eastern Tick-borne encephalitis; 
- Kyasanur Forest disease; 
- Omsk Hemorrhagic Fever; 
- Russian Spring and Summer encephalitis; 
Variola major virus (Smallpox virus) and Variola minor virus 
(Alastrim); 
Yersinia pestis.

USDA Select Agents and Toxins: 

African horse sickness virus; 
African swine fever virus; 
Akabane virus; 
Avian influenza virus (highly pathogenic); 
Bluetongue virus (Exotic); 
Bovine spongiform encephalopathy agent; 
Camel pox virus; 
Classical swine fever virus; 
Cowdria ruminantium (Heartwater); 
Foot-and-mouth disease virus; 
Goat pox virus; 
Japanese encephalitis virus; 
Lumpy skin disease virus; 
Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1); 
Menangle virus; 
Mycoplasma capricolum/M.F38/M. mycoides Capri (contagious caprine 
pleuropneumonia); 
Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia); 
Newcastle disease virus (velogenic); 
Peste des petits ruminants virus; 
Rinderpest virus; 
Sheep pox virus; 
Swine vesicular disease virus; 
Vesicular stomatitis virus (exotic).

Overlap Select Agents and Toxins: 

Bacillus anthracis; 
Botulinum neurotoxins; 
Botulinum neurotoxin producing species of Clostridium; 
Brucella abortus; 
Brucella melitensis; 
Brucella suis; 
Burkholderia mallei (formerly Pseudomonas mallei); 
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei); 
Clostridium perfringens epsilon toxin; 
Coccidioides immitis; 
Coxiella burnetii; 
Eastern Equine Encephalitis virus; 
Francisella tularensis; 
Hendra virus; 
Nipah virus; 
Rift Valley fever virus; 
Shigatoxin; 
Staphylococcal enterotoxins; 
T-2 toxin; 
Venezuelan Equine Encephalitis virus. 

USDA Plant Protection and Quarantine (PPQ) Select Agents and Toxins: 

Candidatus Liberobacter africanus; 
Candidatus Liberobacter asiaticus; 
Peronosclerospora philippinensis; 
Ralstonia solanacearum race 3, biovar 2; 
Schlerophthora rayssiae var zeae; 
Synchytrium endobioticum; 
Xanthomonas oryzae pv. Oryzicola; 
Xylella fastidiosa (citrus variegated chlorosis strain).

[End of section] 

Appendix IV: Biological Agents Recommended for BSL-3 or BSL-4 
Containment that Are Not Select Agents: 

[End of section] 

There are a number of biological agents causing severe illness or death 
that are not select agents. For example, there are five agents that are 
recommended for containment at BSL-4 because of (1) their close 
antigenic relationship with a known BSL-4 agent and (2) the fact that 
there is insufficient experience working with them (see table 5). 

Table 5: Nonselect Agents Recommended for BSL-4 Containment: 

Agent: Absettarov; 
Family: Flavivirus.

Agent: Alkhumra; 
Family: Flavivirus.

Agent: Hanzalova; 
Family: Flavivirus.

Agent: Hypr; 
Family: Flavivirus.

Agent: Kumlinge; 
Family: Flavivirus.

Source: GAO analysis of BMBL data, 5th Edition:

[End of table] 

BMBL containment and safety recommendations for B. anthracis, the 
causative agent for anthrax and a select agent, are to include the use 
of BSL-2 practices, containment equipment, and facilities for clinical 
and diagnostic quantities of infectious cultures. However, BSL-3 
practices, containment equipment, and facilities are recommended for 
(1) work involving production quantities or high concentrations of 
cultures, screening environmental samples especially with powders, and 
(2) for activities with a high potential for aerosol production. Safety 
and containment recommendations for some agents, which are not 
regulated under the Select Agent Program, are as strict or stricter 
than the recommendations for B. anthracis. Some nonselect agents, to 
which containment recommendations at BSL-3 under certain conditions 
apply, are listed in table 6. 

Table 6: Some Nonselect Agents Requiring BSL-3 Containment under 
Certain Conditions: 

Agent: Bordetella pertussis; 
Disease: pertussis (whooping cough).

Agent: Chlamydia psittaci; 
Disease: psittacosis.

Agent: Mycobacterium tuberculosis complex; 
Disease: tuberculosis.

Agent: Neisseria gonorrhoeae; 
Disease: gonorrhea.

Agent: Neisseria meningitidis; 
Disease: meningitis, septicema.

Agent: Salmonella typhi; 
Disease: typhoid fever.

Agent: Hepatitis B, C, and D viruses; 
Disease: hepatitis B, hepatitis C.

Agent: Human herpes virus; 
Disease: herpes simplex et al.

Agent: Noncontemporary human influenza strains (H2N2); 
Disease: influenza.

Agent: Lymphocytic choriomeningitis virus; 
Disease: aseptic meningitis, encephalitis.

Agent: Lyssaviruses; 
Disease: rabies.

Agent: Retroviruses; 
Disease: HIV.

Agent: SARS coronavirus; 
Disease: SARS.

Source: GAO analysis of BMBL data, 5TH Edition:

[End of table]

[End of section] 

Appendix V: Description of Incidents at Texas A&M University: 

TAMU is registered with CDC's Select Agent Program and approved for 
work on several select agents. TAMU has several BSL-3 laboratories and 
works extensively on animal diseases, including those caused by the 
select agents Brucella melitensis, Brucella abortus, and Brucella suis. 
Brucella can cause brucellosis in humans, a disease causing flu-like 
symptoms such as fever and fatigue. But in severe cases, it can cause 
infections of the central nervous system. TAMU is also registered for 
use of Coxiella burnetii, an animal agent that can cause Q fever in 
humans. 

According to the CDC, in February 2006, a lab worker was helping out 
with an experiment to aerosolize Brucella. The lab worker had no 
familiarity with the specifics of working with Brucella, but did have 
experience working with the aerosol chamber. It was determined that the 
lab worker got exposed to the agent during cleaning of the chamber 
after the experiment was run. 

At the time of the exposure, neither the exposed worker nor anyone else 
had any indication that an exposure had taken place. In fact, CDC 
inspectors were on campus days after the Brucella exposure for a 
routine inspection but uncovered nothing that alerted them to the fact 
that an incident had taken place.[Footnote 18] Symptoms did not start 
to appear in the exposed worker until more than a month after the 
exposure, and then the symptoms were flu-like. Confirmation of 
brucellosis was not made until another month had passed and symptoms 
had worsened. However, once the brucellosis determination had been 
made, the worker notified appropriate authorities at TAMU. But no 
report was subsequently made to the CDC as required by federal 
regulation and a year passed before--by chance--an independent watchdog 
group reviewing unrelated documentation,[Footnote 19] acquired through 
the Freedom of Information Act (FOIA),[Footnote 20] uncovered the lapse 
in reporting and forced TAMU to notify the CDC. 

The subsequent investigation by the CDC revealed a number of other 
violations of the select agent regulations including (1) TAMU was not 
authorized to aerosolize Brucella in the first place; (2) a number of 
lab workers from another BSL-3 lab had tested positive for Coxiella 
antigens in their blood serum, suggesting potential exposures had taken 
place for that agent as well, but without reports going to CDC; (3) 
unauthorized access to select agents and toxins; (4) missing vials and 
animals; (5) and other protocol and procedural deficiencies. 

On April 20, 2007, the CDC issued a cease-and-desist order for all work 
on Brucella within the affected high-containment lab, as well as all 
aerosolization work at TAMU involving select agent and toxins. That 
order was subsequently expanded to include all work with select agents 
and toxins at TAMU--the first time the CDC has ever issued such an 
order entitywide under the select agent regulations. That order remains 
in effect as of the date of this testimony. 

[End of section] 

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[End of section] 

Footnotes: 

[1] Biological agent means any microorganism (including, but not 
limited to, bacteria, viruses, fungi, rickettsiae, or protozoa) or 
infectious substance or any naturally occurring, bioengineered, or 
synthesized component of any such microorganism or infectious 
substance, capable of causing death, disease, or other biological 
malfunction in a human, an animal, a plant, or another living organism; 
deterioration of food, water, equipment, supplies, or material of any 
kind; or deleterious alteration of the environment. 

[2] National Institute of Allergy and Infectious Diseases, Survey for 
Determining the Location, Capacity, and Status of Existing and 
Operating BSL-3 Laboratories within the United States (Washington, 
D.C., June 2, 2005). 

[3] Department of Health and Human Services, Biosafety in 
Microbiological and Biomedical Laboratories, 5TH ed. (Washington, DC., 
2007). 

[4] Smallpox is only handled at the CDC labs in Atlanta. 

[5] Private sector labs include commercial labs. 

[6] There are a number of methodological issues associated with 
determining the overall number of BSL-3 and BSL-4 labs. In our 
discussion with federal agency officials, experts, and review of the 
literature, we found that the total number depended upon how you ask 
the question. Most often data were available on the number of 
facilities or sites that contained a BSL-3 or BSL-4 lab. The precise 
number of independent rooms within those facilities qualifying as BSL-
3 or BSL-4 is not generally specified. Some facilities contain more 
than one actual lab. For example, while CDC has two facilities with 
BSL-4 capacity, one of the facilities actually contains within it two 
separate BSL-4 labs, while the other has four separate BSL-4 labs. 
These officials and experts also told us that counting the number of 
labs is problematic because the definition of the term "lab" varies. A 
more meaningful measure is determining the net square footage of 
working BSL-4 space. However, this information is often not available. 

[7] This is lab was built as a BSL-4 but currently operates as an 
enhanced BSL-3. 

[8] Association of Public Health Laboratories, Public Health Laboratory 
Issues in Brief: Bioterrorisn Capacity (Washington D.C., April 2005). 

[9] Some intelligence agencies have a mission to track and a need to 
know the number of all BSL-3 and BSL-4 labs or equivalent abroad. 
However, they do not know the total number of those labs. 

[10] The biosafety officer at TAMU told us the following: He had no 
training in biosafety but was an industrial hygienist by education and 
experience. He was asked to take on the additional duty of biosafety 
officer when the previous biosafety officer retired. He was also 
designated as an alternate responsible officer (RO) but did not know 
what duties he had to perform as an alternate RO. 

[11] High-Containment Biodefense Research Laboratories, Meeting Report 
and Center Recommendations, Biosecurity and Bioterrorism, vol. 5, 1 
(New Rochelle, N.Y.: March 2007). 

[12] Department of Transportation, Federal Aviation Administration, FAA 
Procedures for Handling National Transportation Safety Board 
Recommendations (Washington, D.C.: Federal Aviation Administration, 
March 22, 1995). Also see Federal Aviation Administration, Accident and 
Incident Data (Washington, D.C.: Federal Aviation Administration, Sept. 
29, 2006). 

[13] According to the CDC, regardless of escort, since the lab worker 
was not authorized to work with Brucella, having the lab worker help 
out with the aerosolization chamber during the Brucella experiments 
constituted unauthorized access to a select agent and violated the 
regulations. 

[14] Although a person typically has to breathe in M. tuberculosis 
bacteria to get an infection, Brucella can enter the system through 
mucous membranes such as those in the eyes. During the experiment, the 
lab worker who got exposed had been wearing a respirator that filtered 
the air she breathed as is recommended for work with M. tuberculosis. 

[15] A subsequent third-party investigation determined that the 
grounding of another building housing CDC's older BSL-4 labs was also 
compromised in a similar fashion. 

[16] Department for Environment, Food, and Rural Affairs, Foot and 
Mouth Disease: Applying the Lessons (London, U.K.: National Audit 
Office, Feb. 2, 2005). 

[17] Reconstructed replication-competent forms of the 1918 pandemic 
influenza virus containing any portion of the coding regions of all 
eight gene segments. 

[18] The CDC inspected labs at TAMU on February 22, 2006, and 
documented 47 facility "departures," but did not note any of the 
violations later uncovered. 

[19] The Sunshine Project, Mandate for Failure, The State of 
Institutional Biosafety Committees in an Age of Biological Weapons 
Research (Austin, Texas, Oct. 4, 2004). 

[20] 5 U.S.C. § 552. 

[End of section] 

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