CDC also funds some  laboratory activities carried out in state public health laboratories,  commonly referred to as the Laboratory Response Network (LRN). The Bioterrorism Act expanded the select agent program by    granting comparable regulatory authorities to USDA for biological agents  and toxins that present a severe threat to plant or animal health or plant or  animal products;  requiring coordination/concurrence between USDA and HHS on select  agents and toxins regulated by both agencies (“overlap” agents and  toxins);  requiring the Secretaries of USDA and HHS to establish and maintain a list  of each biological agent and toxin (select agent and toxin) that has the  potential to pose a severe threat to public health and safety, animal or  plant health, or animal or plant products and directing the Secretaries of  HHS and Agriculture to biennially review and republish the select agent  list, making revisions as appropriate to protect the public;  requiring the Secretaries by regulation to provide for registration of  facilities for the possession, use, and transfer of select agents and toxins,  not just for those facilities sending or receiving select agents;  requiring the Attorney General (delegated to the FBI’s Criminal Justice  Information Services Division) to check criminal, immigration, national  security, and other electronic databases with information submitted in the  registration process for all individuals and nongovernmental entities to  determine if the registrant is a restricted person as defined in the USA  PATRIOT Act or has been reasonably suspected by federal law  enforcement or intelligence agencies of committing a federal crime of  terrorism or having known involvement in an organization that engages in  terrorism or is an agent of a foreign power (this is called a security risk  assessment);  requiring the Secretaries to establish a national database that includes the  names and locations of registered entities; the lists of agents and toxins  such entities possess, use, or transfer; and information regarding the  characterizations of such agents and toxins;  requiring the Secretaries to promulgate regulations that include safeguard  and security requirements for persons possessing, using, or transferring a  select agent or toxin commensurate with the risk such an agent or toxin  poses to public, animal, and plant health and safety, including required  notification to the Secretaries and law enforcement agencies of theft, loss,  or release of a listed agent or toxin; and    establishing civil money penalties for persons violating the regulations and  additional criminal penalties for knowingly possessing a select agent or  toxin without registering it or knowingly transferring a select agent or  toxin to an unregistered person. 3. The expansion of high-containment laboratories in the United States began  in response to the emergency situation resulting from the anthrax attacks  in 2001. Understandably, the expansion initially lacked a clear,  governmentwide coordinated strategy. In that emergency situation, the  expansion was based on the perceptions of individual agencies about the  capacity required for their high-containment laboratory activities as well  as the availability of congressionally approved funding. Decisions to fund  the construction of high-containment laboratories were made by multiple  federal agencies in multiple budget cycles. Federal and state agencies,  academia, and the private sector considered their individual requirements,  but a robust assessment of national needs was lacking. Even now, after more than 7 years, we have not been  able to find any detailed projections based on a governmentwide strategic  evaluation of future capacity requirements in light of existing capacity; the  numbers, location, and mission of the laboratories needed to effectively  counter biothreats; and national public health goals. Without this  information, there is little assurance of having facilities in the right places  with the right specifications to meet a governmentwide strategy. High-containment laboratories can pose health risks for individual  laboratory workers as well as the surrounding community. However, the lessons we have  identified highlight ways to improve biosafety and biosecurity. Lessons Learned: Insider Risk and Inventory Control of Biological Agents

This incident highlights two lessons: (1) an ill-intentioned insider can pose  a risk not only by passing on confidential information but also by  removing dangerous material from a high-containment laboratory, and (2)  it is impossible to have completely effective inventory control of biological  material with currently available technologies. The Pirbright incident shows that beyond initial design and construction,  ongoing maintenance plays a critical role in ensuring that high- containment laboratories operate safely and securely over time. Furthermore, since no single agency is in charge of the current expansion,  no one is determining the associated aggregate risks posed by the  expansion. As a consequence, no federal agency can determine whether  high-containment laboratory capacity may now be less than, meet, or  exceed the national need or is at a level that can be operated safely. If an agency were tasked or a mechanism were established with the  purpose of overseeing the expansion of high-containment laboratories, it  could develop a strategic plan to (1) ensure that the number and  capabilities of potentially dangerous high-containment laboratories are no  greater or less than necessary, (2) balance the risks and benefits of  expanding such laboratories, and (3) determine the type of oversight  needed. Recommendations for Executive Action

We recommend that the National Security Advisor, in consultation with  the Secretaries of Health and Human Services (HHS), Agriculture (USDA),  Defense (DOD), and Homeland Security (DHS); the National Intelligence  Council; and other executive departments as deemed appropriate identify  a single entity charged with periodic governmentwide strategic evaluation  of high-containment laboratories that will  the number, location, and mission of the laboratories needed to effectively  meet national goals to counter biothreats;  the existing capacity within the United States;  the aggregate risks associated with the laboratories’ expansion; and  the type of oversight needed  and (2) develop, in consultation with the scientific community, national  standards for the design, construction, commissioning, and operation of  high-containment laboratories, specifically including provisions for long- term maintenance. To develop lessons learned from recent incidents at four high-containment  laboratories, 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 laboratories, including the sites involved in the recent incidents. GAO Comments

1.
Why GAO Did This Study

U.S. laboratories working with dangerous biological pathogens (commonly referred to as high-containment laboratories) have proliferated in recent years. As a result, the public is concerned about the oversight of these laboratories. The deliberate or accidental release of biological pathogens can have disastrous consequences. GAO was asked to determine (1) to what extent, and in what areas, the number of high-containment laboratories has increased in the United States, (2) which federal agency is responsible for tracking this expansion and determining the associated aggregate risks, and (3) lessons learned from highly publicized incidents at these laboratories and actions taken by the regulatory agencies. To carry out its work, GAO surveyed and interviewed federal agency officials, (including relevant intelligence community officials), consulted with experts in microbiology, reviewed literature, conducted site visits, and analyzed incidents at high-containment laboratories.

What GAO Found

The recent expansion of high-containment laboratories in the United Statesbegan in response to the need to develop medical countermeasures after the anthrax attacks in 2001. Understandably, the expansion initially lacked a clear, governmentwide coordinated strategy. In that emergency situation, the expansion was based on individual agency perceptions of the capacity their high-containment labs required as well as the availability of congressionally approved funding. Decisions to fund the construction of high-containment labs were made by multiple federal agencies in multiple budget cycles. Federal and state agencies, academia, and the private sector considered their individual requirements, but an assessment of national needs was lacking. Even now, after more than 7 years, GAO was unable to find any projections based on a governmentwide strategic evaluation of future capacity requirements set in light of existing capacity; the numbers, location, and mission of the laboratories needed to effectively counter biothreats; and national public health goals. Such information is needed to ensure that the United States will have facilities in the right place with the right specifications. Furthermore, since no single agency is in charge of the expansion, no one is determining the aggregate risks associated with this expansion. As a consequence, no federal agency can determine whether high-containment laboratory capacity may now meet or exceed the national need or is at a level that can be operated safely. If an agency were tasked, or a mechanism were established, with the purpose of overseeing the expansion of high-containment laboratories, it could develop a strategic plan to (1) ensure that the numbers and capabilities of potentially dangerous high-containment laboratories are no greater than necessary, (2) balance the risks and benefits of expanding such laboratories, and (3) determine the type of oversight needed. Four highly publicized incidents in high-containment laboratories, as well as evidence in scientific literature, demonstrate that (1) while laboratory accidents are rare, they do occur, primarily due to human error or systems (management and technical operations) failure, including the failure of safety equipment and procedures, (2) insiders can pose a risk, and (3) it is difficult to control inventories of biological agents with currently available technologies. Taken as a whole, these incidents demonstrate failures of systems and procedures meant to maintain biosafety and biosecurity in high-containment laboratories. For example, they revealed the failure to comply with regulatory requirements, safety measures that were not commensurate with the level of risk to public health posed by laboratory workers and pathogens in the laboratories, and the failure to fund ongoing facility maintenance and monitor the operational effectiveness of laboratory physical infrastructure. Oversight plays a critical role in improving biosafety and ensuring that high-containment laboratories comply with regulations. However, some aspects of the current oversight programs provided by the Departments of Health and Human Services and Agriculture are dependent upon entities monitoring themselves and reporting incidents to federal regulators. Since 2001, personnel reliability programs have been established to counter insider risks, but their cost, effectiveness, and impact has not been evaluated.