	Select Agent Program Does Not Fully Meet Key Elements of Effective Oversight or Have Joint Strategic Planning Documents to Guide Its Efforts

The Select Agent Program does not fully meet key elements of effective  oversight. In addition, the  program does not have joint strategic planning documents to guide its  oversight efforts, such as a joint strategic plan and workforce plan. First, regarding independence, the Select Agent Program is not  structurally distinct and separate from all of the laboratories it oversees  because the two components of the Select Agent Program are located in  CDC and APHIS, both of which also have high-containment laboratories  registered with the program. The program itself has not  formally assessed all potential risks posed by its current structure and the  effectiveness of its mechanisms to address those risks. Without (1) regularly  assessing the potential risks posed by the program’s current structure  and the effectiveness of its mechanisms to address them and (2) taking  actions as necessary to ensure any identified risks are addressed, the  program may not be aware of or effectively mitigate impairments to its  independence that could affect its ability to achieve its objectives. However, the program may  not target the highest-risk activities in its inspections, in part because it  has not formally assessed which activities pose the highest risk to  biological safety and security. Without developing and  implementing a plan to identify which laboratory activities carry the  highest biological safety and security risks and to respond to those risks  by aligning inspections and other oversight efforts to target those  activities, the Select Agent Program will not have assurance that it is  effectively balancing the potential safety and security gains from its  oversight efforts against the use of program resources and the effect on  laboratories’ research. The program began taking steps to develop a joint  strategic plan during the course of our review and, in August 2017, began  soliciting bids from contractors for the plan’s development. Developing a joint workforce plan that assesses workforce and training  needs for the program as a whole would help the program to better  manage fragmentation by improving how it leverages resources to ensure  all workforce and training needs are met. Selected Countries and Regulatory Sectors Employ Other Approaches to Promote Effective Oversight

Selected countries and regulatory sectors employ approaches to promote  effective oversight that sometimes differ from those of the Select Agent  Program by, for example, having regulatory bodies that are structurally  independent from the entities they oversee or taking a risk-based  approach to performing reviews. To illustrate, with regard to  independence, Great Britain’s Health and Safety Executive, whose  mission is to protect worker and public health and safety and which  oversees laboratories that work with pathogens, is an independent  government agency. In both Great Britain and Canada, the organizations that  oversee laboratories generally focus their oversight on (1) biological  safety, and (2) regulation of all potentially hazardous pathogens 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 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.

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.