High-Containment Laboratories:

Coordinated Efforts Needed to Further Strengthen Oversight of Select Agents

GAO-18-197T: Published: Nov 2, 2017. Publicly Released: Nov 2, 2017.

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Mary E. Deniganmacauley
(202) 512-7114
deniganmacauleym@gao.gov

 

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Laboratories conduct research on hazardous pathogens—such as Ebola virus or anthrax bacteria—in more than 200 labs in the United States. Safety lapses have occurred at some of these labs, raising concerns about whether oversight is effective.

For this testimony, we looked at the Federal Select Agent Program, which is responsible for overseeing these labs, and found room for improvement. For example, the program allows some agencies to oversee their own labs, which could potentially lead to conflicts of interest. In the report on which this testimony is based, we recommended 11 actions to improve oversight.

 

A photo of a scientist in protective gear working in a high-containment laboratory.

A photo of a scientist in protective gear working in a high-containment laboratory.

Additional Materials:

Contact:

Mary E. Deniganmacauley
(202) 512-7114
deniganmacauleym@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

What GAO Found

The Federal Select Agent Program—jointly managed by the Departments of Health and Human Services (HHS) and Agriculture (USDA)—oversees laboratories’ handling of certain hazardous pathogens known as select agents. However, the program does not fully meet all key elements of effective oversight. For example, the program is not structurally independent from all laboratories it oversees and has not assessed risks posed by its current structure or the effectiveness of mechanisms it has to reduce organizational conflicts of interest. Without conducting such assessments and taking actions as needed to address risks, the program may not effectively mitigate impairments to its independence. 
 
In addition, some experts and laboratory representatives GAO interviewed raised concerns that the program’s reviews may not target the highest-risk activities, in part because it has not formally assessed which activities pose the highest risk. Without assessing the risk of activities it oversees and targeting its resources appropriately, the program cannot ensure it is balancing its resources against their impact. 
 
Moreover, the program does not have strategic planning documents, such as a joint strategic plan and workforce plan, to guide its oversight. Although it began taking steps to develop a joint strategic plan, the program is not developing workforce plans as part of this effort. Developing a joint workforce plan that assesses workforce and training needs for the program as a whole would help the program leverage resources to ensure all workforce and training needs are met. 
 
Selected countries and regulatory sectors GAO reviewed employ other approaches to promote effective oversight. For example, in Great Britain, an independent government agency focused on health and safety oversees laboratories that work with pathogens. In addition, in both Great Britain and Canada, regulators (1) focus their oversight on biological safety, because safety incidents provided the impetus for laboratory oversight in these countries and (2) regulate all potentially hazardous pathogens and activities in laboratories.

Why GAO Did This Study

Safety lapses have occurred at laboratories in the United States that conduct research on select agents—such as Ebola virus or anthrax bacteria—that may cause serious or lethal infection in humans, animals, or plants, raising concerns about whether oversight is effective. This statement summarizes information contained in GAO’s October 2017 report, titled High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program’s Oversight of Hazardous Pathogens (GAO-18-145).

What GAO Recommends

GAO’s recommendations in GAO-18-145 included that the Federal Select Agent Program (1) assess risks posed by its current structure and address risks as needed; (2) assess the risk of activities it oversees and target reviews to the highest-risk activities; and (3) develop a joint workforce plan. HHS and USDA agreed with GAO’s recommendations and outlined actions they are taking, or plan to take, to address them, which GAO will continue to monitor.

For more information, please contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.

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