High-Containment Laboratories:

National Strategy for Oversight Is Needed

GAO-09-574: Published: Sep 21, 2009. Publicly Released: Sep 21, 2009.

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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.

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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 1). In March 2010, the Select Agent Program (SAP) Animal and Plant Health Inspection Service (APHIS) in USDA, revised its definition of exposure to select agents. It provided theft, loss and release scenarios to clarify the circumstances and events that lead to reportable events of exposure. While these have helped inform users about certain reportable events, we hope in the future they they will provide criteria for exposure. 2). In April 2010, the SAP's APHIS developed a mechanism for sharing lessons learned from laboratory accidents. It created an Office of Inspector General (OIG) hotline that allows individuals to anonymously report safety and security issues related to select agents and toxins.

    Recommendation: Recognizing that biological agent inventories cannot be completely controlled at present, the Secretaries of HHS and USDA should review existing inventory control systems and invest in and develop appropriate technologies to minimize the potential for insider misuse of biological agents.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: The USDA/Animal and Plant Health Inspection Service (APHIS) Select Agent Program (SAP) published revised select agent inventory guidance. To help enhance inventory-control systems of entities registered with the SAP, APHIS collaborated to finalize the June 2011 Guidance on the Definition of Long Term Storage as Used in the Select Agent Regulations to provide additional explanation for the term "long-term storage" used in Section 17 of the Select Agent Regulations. While this is a helpful effort, USDA has not told GAO of any efforts to invest and develop appropriate technologies to minimize insider misuse.

    Recommendation: Recognizing that biological agent inventories cannot be completely controlled at present, the Secretaries of HHS and USDA should review existing inventory control systems and invest in and develop appropriate technologies to minimize the potential for insider misuse of biological agents.

    Agency Affected: Department of Agriculture

  3. Status: Closed - Not Implemented

    Comments: In 2010, the Federal Experts Security Advisory Panel advised the USDA/Animal Plant and Health Inspection Service (APHIS) Select Agent Program (SAP) about security issues and recommended provisions to improve personnel reliability. To carry them out, APHIS's SAP has initiated rulemaking activities and anticipates the publication of a Notice of Proposed Rulemaking (NPRM) in fall 2011 that included a Regulatory Impact Analysis and Initial Regulatory Flexibility Analysis, which includes a fiscal analysis. It was made final in the fall of 2012. This study assessed the impact on registered entities, but did not evaluate the impact on individuals such as laboratorians as a way to address insider risk.

    Recommendation: If the Secretaries of HHS and USDA consider implementing a personnel reliability program for high-containment laboratories to deal with insider risk, they should evaluate and document the cost and impact of such a program.

    Agency Affected: Department of Agriculture

  4. Status: Closed - Not Implemented

    Comments: In 2010, the Federal Experts Security Advisory Panel advised the HHS/CDC?s Select Agent Program (SAP) about security issues and recommended provisions to improve personnel reliability. To carry them out, CDC's SAP has initiated rulemaking activities and anticipates the publication of a Notice of Proposed Rulemaking (NPRM) in fall 2011 that included a Regulatory Impact Analysis and Initial Regulatory Flexibility Analysis, which includes a fiscal analysis. It was made final in the fall of 2012. These changes assessed the impact on registered entities, but did not evaluate the impact on individuals such as laboratorians as a way to address insider risk.

    Recommendation: If the Secretaries of HHS and USDA consider implementing a personnel reliability program for high-containment laboratories to deal with insider risk, they should evaluate and document the cost and impact of such a program.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: 1). In March 2010, the Select Agent Program (SAP')s Animal Plant Health Inspection Service (APHIS) in USDA, revised its definition of exposure to select agents. It provided theft, loss and release scenarios to clarify the circumstances and events that lead to reportable events of exposure. 2). In April 2010, the SAP's APHIS developed a mechanism for sharing lesson learned from laboratory accidents. It created an Office of Inspector General (OIG) hotline that allows individuals to anonymously report safety and security issues related to select agents and toxins.

    Recommendation: The Secretaries of HHS and USDA should develop (1) a clear definition of exposure to select agents and (2) a mechanism for sharing lessons learned from reported laboratory accidents so that best practices--for other operators of high-containment laboratories--can be identified.

    Agency Affected: Department of Agriculture

  6. Status: Closed - Not Implemented

    Comments: National Security Staff (NSS) in the Executive Office of the President (EOP) provided no comments to the draft report in 2009. In 2012, when the EOP finally responded to GAO, the NSS provided few comments and disagreed with the recommendation.

    Recommendation: 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, should, as deemed appropriate, identify a single entity charged with periodic governmentwide strategic evaluation of high-containment laboratories that will (1) determine (a) the number, location, and mission of the laboratories needed to effectively meet national goals to counter biothreats; (b) the existing capacity within the United States; (c) the aggregate risks associated with the laboratories' expansion; and (d) 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.

    Agency Affected: Executive Office of the President: National Security Council

  7. Status: Closed - Implemented

    Comments: 1). In March 2010, the HHS/Centers for Disease Control and Prevention (CDC) Select Agent Program (SAP) revised its definition of exposure to select agents. It provided theft, loss and release scenarios to clarify the circumstances and events that lead to reportable events of exposure 2). In 2010, the SAP's CDC developed a mechanism for sharing lessons learned from laboratory accidents. It created an Office of Inspector General (OIG) hotline that allows individuals to anonymously report safety and security issues related to select agents and toxins.

    Recommendation: The Secretaries of HHS and USDA should develop (1) a clear definition of exposure to select agents and (2) a mechanism for sharing lessons learned from reported laboratory accidents so that best practices--for other operators of high-containment laboratories--can be identified.

    Agency Affected: Department of Health and Human Services

 

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