Select agent regulations govern the possession, use, and transfer of  designated select agents. Select Agent Program Does Not Fully Meet Key Elements of Effective Oversight or Have Joint Strategic Planning Documents to Guide Its Efforts Select Agent Program Does Not Fully Meet Oversight Elements Related to Independence, Performing Reviews, Technical Expertise, Transparency, and Enforcement

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; it did,  however, begin taking steps to develop a joint strategic plan over the  course of our review. Specifically, the program is not independent from all  laboratories it oversees, and it has not formally assessed the potential  risks posed by its current organizational structure. The Select Agent Program is not  structurally distinct and separate from all of the laboratories it oversees  but has taken some steps to reduce conflicts of interest potentially posed  by its current structure within CDC and APHIS. Without  (1) regularly assessing the potential risks posed by the program’s current  structure and the effectiveness of its mechanisms to address them, such  as by commissioning external reviews, 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. Select Agent Program Has Taken Steps to Hire Additional Expert Staff and Improve Technical Expertise, but Gaps in Workforce and Training Remain

According to our key elements of effective oversight, the organization  conducting oversight should have sufficient staff with the expertise to  perform sound safety and security assessments. According to  our past work, strategic workforce planning is an essential tool to help  agencies align their workforces with their current and emerging missions  and develop long-term strategies for acquiring, developing, and retaining  staff. Moreover, the Select Agent Program has not collectively  determined its training needs. Selected Countries and Regulatory Sectors Employ Other Approaches to Promote Effective Oversight

Selected countries and regulatory sectors employ approaches to promote  effective oversight that, in some cases, differ from those of the Select  Agent Program. According to officials from the Health and Safety Executive and laboratory  representatives we interviewed, one strength of this approach is that it  avoids potential organizational conflicts of interest because none of the  laboratories that the Health and Safety Executive oversees are part of the  same agency. It began overseeing laboratories  following a smallpox outbreak in 1978. Some other regulatory sectors in the United States are also structurally  independent from regulated facilities as a mechanism to ensure  independence. In addition to having less prescriptive inventory requirements than the  Select Agent Program, both Great Britain’s Health and Safety Executive  and the Public Health Agency of Canada generally focus their  oversight on (1) biological safety, and (2) regulation of all potentially  hazardous pathogens in laboratories. Both Great  Britain and Canada have additional oversight requirements, such as  security clearances for personnel, for a limited number of pathogens for  which they have heightened security concerns, similar to the security  requirements for working with select agents in the U.S. For example, in  Great Britain, the Health and Safety Executive focuses on only biological  safety in its oversight of high-containment laboratories and works with the  National Counter Terrorism Security Office for oversight of pathogens  with biological security concerns. 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; this assessment should be done in conjunction with the development  of the strategic plan. If you or your staff have any questions about this report, please contact  Timothy M. Persons, Chief Scientist, at (202) 512-6412 or  personst@gao.gov or John Neumann, Director, Natural Resources and  Environment, at (202) 512-3841 or neumannj@gao.gov. We  compared information from federal documents about the Select Agent  Program’s oversight, interviews with laboratory representatives and  agency officials, and our expert meeting against the five elements of  effective oversight.
Why GAO Did This Study

Safety lapses continue to occur at some of the 276 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.
GAO was asked to review the federal oversight approach for select agents and approaches from other countries or regulatory sectors. This report (1) evaluates the extent to which the Select Agent Program has elements of effective oversight and strategic planning documents to guide it, and (2) identifies approaches selected countries and regulatory sectors have used to promote effective oversight.
GAO convened a meeting of experts with the help of the National Academy of Sciences to discuss oversight of select agents. GAO also reviewed relevant laws, regulations, and guidance, and interviewed officials from the Select Agent Program and laboratories it oversees. GAO also reviewed documents and interviewed officials from two countries and other U.S. sectors selected because they have alternate oversight approaches.

What GAO Found

The Federal Select Agent Program (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, but the program does not fully meet all key elements of effective oversight, as illustrated in the following examples:
GAO's past work identified independence as a key element of effective oversight. However, the Select Agent Program is not structurally independent from all laboratories it oversees, and it 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.
Another key element of effective oversight is the ability to perform reviews. Some experts and laboratory representatives 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.
Technical expertise is another key element GAO identified in past work. The Select Agent Program has taken steps to hire additional expert staff and improve training, but workforce and training gaps remain.
Moreover, the program does not have joint strategic planning documents to guide its oversight. Although it began taking steps to develop a joint strategic plan during GAO's review, the program is not developing workforce plans as part of this effort. GAO's past work has found that strategic workforce planning is an essential tool to help agencies align their workforces with their missions and develop long-term strategies for acquiring, developing, and retaining staff. 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 promote effective oversight using approaches that differ from the U.S. Select Agent Program's approaches:
In Great Britain, oversight of laboratories that work with pathogens is under an independent government agency focused on health and safety.
In both Great Britain and Canada, regulators focus their oversight on (1) biological safety, due to safety incidents which provided the impetus for laboratory oversight in these countries; and (2) regulation of all potentially hazardous pathogens and activities in laboratories.

What GAO Recommends

GAO is making 11 recommendations for the Select Agent Program, including to (1) assess risks from its current structure and the effectiveness of its mechanisms to reduce conflicts of interest and address risks as needed, (2) assess the risk of activities it oversees and target reviews to high-risk activities, and (3) develop a joint workforce plan. HHS and USDA agreed with GAO's recommendations.
or John Neumann at (202) 512-3841 or neumannj@gao.gov .