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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
National Security Council 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.
Closed - Not Implemented
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.
Department of Agriculture 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.
Closed - Implemented
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.
Department of Health and Human Services 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.
Closed - Not Implemented
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.
Department of Agriculture 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.
Closed - Not Implemented
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.
Department of Agriculture 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.
Closed - Not Implemented
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.
Department of Health and Human Services 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.
Closed - Implemented
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.
Department of Health and Human Services 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.
Closed - Implemented
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.

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