High-Containment Biosafety Laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States
Published: 2007-10-04T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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 ), 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, 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. 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).
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: BSL-3 and BSL-4 Labs
paragraphs: 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, 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.
section_title: Federal Agencies and BSL- 3 and BSL-4 Labs
paragraphs: 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.
section_title: Pertinent Laws and Guidance
subsections: section_title: Pertinent Laws
paragraphs: 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.
section_title: Pertinent Guidance
paragraphs: 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.
section_title: The Select Agent Program
paragraphs: 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.
section_title: Expansion of BSL-3 and BSL-4 Labs Is Taking Place across Many Sectors and All over the United States
paragraphs: An expansion in the number of BSL-3 and BSL-4 labs is taking place across  most of the United States, 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.
subsections: section_title: An Expansion of BSL-3 and BSL-4 Labs Is Taking Place in All Sectors in the United States
paragraphs: 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; 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.)
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).
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. 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.
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.
section_title: No Federal Agency Has the Mission to Track High- Containment Labs in the United States
paragraphs: 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).
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. 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.
section_title: Lessons Learned from Three Recent Incidents Highlight the Risks Inherent in the Expansion of High-Containment Labs
paragraphs: 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.
subsections: section_title: Identifying and Overcoming Barriers to Reporting
paragraphs: 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.
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. 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. 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.
section_title: Training Lab Staff in General Biosafety, as well as in Specific Agents Being Used in the Labs
paragraphs: 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. 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.
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.
section_title: Developing Mechanisms for Informing Medical Providers about All the Agents that Lab Staff Work with
paragraphs: 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.
section_title: Addressing Confusion over the Definition of Exposure
paragraphs: 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.
section_title: Ensuring that BSL-4 Labs’ Safety and Security Measures Are Commensurate with the Level of Risk These Labs Present
paragraphs: 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.
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.
section_title: Maintenance of High- Containment Labs
paragraphs: 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. 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.
section_title: Concluding Observations
paragraphs: 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.
section_title: Contacts and Acknowledgments
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Pertinent Regulations
paragraphs: 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.
section_title: Appendix III: The Select Agents and Toxins List
paragraphs: 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  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)
section_title: Appendix IV: Biological Agents Recommended for BSL-3 or BSL-4 Containment that Are Not Select Agents
paragraphs: 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).
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.
section_title: Appendix V: Description of Incidents at Texas A&M University
paragraphs: 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. 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, acquired through the Freedom of Information Act  (FOIA), 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.
section_title: Related GAO Products
paragraphs: Export Controls: Vulnerabilities and Inefficiencies Undermine System’s  Ability to Protect U.S. Interests. GAO-07-1135T. Washington, D.C.: July 26,  2007.
Biological Research Laboratories: Issues Associated with the Expansion  of Laboratories Funded by the National Institute of Allergy and  Infectious Diseases. GAO-07-333R. Washington, D.C.: February 22, 2007.
Export Controls: Challenges Exist in Enforcement of an Inherently  Complex System. GAO-07-265. Washington, D.C.: December 20, 2006.
Export Controls: Agencies Should Assess Vulnerabilities and Improve  Guidance for Protecting Export-Controlled Information at Universities.  GAO-07-70. Washington, D.C.: December 5, 2006.
Defense Technologies: DOD’s Critical Technologies Lists Rarely Inform  Export Control and Other Policy Decisions. GAO-06-793. Washington,  D.C.: July 26, 2006.
Homeland Security: Management and Coordination Problems Increase  the Vulnerability of U.S. Agriculture to Foreign Pests and Disease.  GAO-06-644. Washington, D.C.: May 19, 2006.
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.: December 19, 2005.
Homeland Security: Much Is Being Done to Protect Agriculture from a  Terrorist Attack, but Important Challenges Remain.   GAO-05-214. Washington, D.C.: March 8, 2005.
Combating Bioterrorism: Actions Needed to Improve Security at Plum  Island Animal Disease Center. GAO-03-847. Washington, D.C.: September  19, 2003.
Homeland Security: CDC’s Oversight of the Select Agent Program.  GAO-03-315R. Washington, D.C.: November 22, 2002.
This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.