High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program's Oversight of Hazardous Pathogens
GAO-18-145
Published: Oct 19, 2017. Publicly Released: Oct 31, 2017.
Fast Facts
Laboratories conduct research on hazardous pathogens—such as Ebola virus or anthrax bacteria—in more than 200 labs in the United States. Safety lapses continue to occur at some of these labs, raising concerns about whether oversight is effective.
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. We recommended 11 actions to improve oversight.
This figure shows a scientist working in a high-containment laboratory.
Highlights
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.
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.
Recommendations
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.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Animal and Plant Health Inspection Service | To improve independence, the Administrator of APHIS should formally document the reporting structure for the APHIS component of the Select Agent Program from the APHIS director of the program to the Administrator of APHIS. (Recommendation 1) |
On April 9, 2018, USDA finalized a standard operating procedure that outlines the reporting structure for the director of the APHIS component of the Select Agent Program to the APHIS Office of the Administrator. The procedure states that this reporting structure was established to maintain the independence of the Select Agent Program. In particular, the procedure states that the APHIS Select Agent Program director is to communicate routinely and directly with the APHIS Office of the Administrator regarding incident reports involving select agents at APHIS entities as well as high-profile incidents at non-APHIS entities. In addition, it states that the program director is to meet with the APHIS Office of the Administrator on a monthly basis to provide a summary of enforcement actions, policy planning, and other program management activities. The procedure also states that decisions and policy related to the APHIS component of the Select Agent Program are to be made by either the Select Agent Program director or, when higher levels of authority are necessary, the APHIS Office of the Administrator.
|
| Centers for Disease Control and Prevention | To improve independence, the CDC director of the Select Agent Program should work with APHIS to establish control activities to help ensure that each component of the program carries out its inspection responsibilities as outlined in the program's memorandum of understanding. (Recommendation 2) |
In December 2017, the Select Agent Program finalized a joint standard operating procedure that states that APHIS will lead inspections for all CDC-owned laboratories and CDC will lead inspections for APHIS-owned entities, consistent with the program's memorandum of understanding. The CDC and APHIS directors of the Select Agent Program conduct biweekly coordination meetings to schedule upcoming inspections and ensure that the memorandum of understanding and standard operating procedure are being properly implemented, according to the Select Agent Program. Before scheduled inspections are finalized and prior to inspections being conducted, CDC and APHIS verify that CDC leads inspections of all APHIS-owned laboratories and that APHIS leads inspections of CDC-owned laboratories, according to the Select Agent Program. This is also verified during briefings after each inspection is conducted, according to the Select Agent Program.
|
| Animal and Plant Health Inspection Service | To improve independence, the APHIS director of the Select Agent Program should work with CDC to establish control activities to help ensure that each component of the program carries out its inspection responsibilities as outlined in the program's memorandum of understanding. (Recommendation 3) |
In December 2017, the Select Agent Program finalized a joint standard operating procedure that states that APHIS will lead inspections for all CDC-owned laboratories and CDC will lead inspections for APHIS-owned entities, consistent with the program's memorandum of understanding. The CDC and APHIS directors of the Select Agent Program conduct biweekly coordination meetings to schedule upcoming inspections and ensure that the memorandum of understanding and standard operating procedure are being properly implemented, according to the Select Agent Program. Before scheduled inspections are finalized and prior to inspections being conducted, CDC and APHIS verify that CDC leads inspections of all APHIS-owned laboratories and that APHIS leads inspections of CDC-owned laboratories, according to the Select Agent Program. This is also verified during briefings after each inspection is conducted, according to the Select Agent Program.
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| Centers for Disease Control and Prevention | To improve independence, the CDC director of the Select Agent Program should regularly assess the potential risks posed by the program's structure and the effectiveness of its mechanisms to address those risks, such as by commissioning external reviews, and take actions as necessary to ensure that any identified risks are addressed so that impairments to independence do not affect its ability to achieve its objectives. (Recommendation 4) |
The Select Agent Program contracted an external review to assess potential risks posed by the program's structures within CDC and APHIS, which was finalized in March 2019. It included eight recommendations to the Select Agent Program to improve program independence. As of September 2020, the Select Agent Program had taken a number of steps to address the recommendations, including realigning APHIS's reporting structure, documenting the program's decision-making process, and initiating a quality assurance initiative, according to program documents and officials. Moving forward, risks posed by the program's structure will be regularly assessed by an independent board, according to a senior program official.
|
| Animal and Plant Health Inspection Service | To improve independence, the APHIS director of the Select Agent Program should regularly assess the potential risks posed by the program's structure and the effectiveness of its mechanisms to address those risks, such as by commissioning external reviews, and take actions as necessary to ensure any identified risks are addressed so that impairments to independence do not affect its ability to achieve its objectives. (Recommendation 5) |
The Select Agent Program contracted an external review to assess potential risks posed by the program's structures within CDC and APHIS, which was finalized in March 2019. It included eight recommendations to the Select Agent Program to improve program independence. As of September 2020, the Select Agent Program had taken a number of steps to address the recommendations, including realigning APHIS's reporting structure, documenting the program's decision-making process, and initiating a quality assurance initiative, according to program documents and officials. Moving forward, risks posed by the program's structure will be regularly assessed by an independent board, according to a senior program official.
|
| Centers for Disease Control and Prevention | To improve the ability to perform reviews, the CDC director of the Select Agent Program should work with APHIS to develop and implement 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. (Recommendation 6) |
As of September 2020, the Select Agent Program is determining inspection scheduling and other oversight activities based on risk using a combination of entities' registration and compliance scores, according to agency officials. The registration score is based on entities' registration form (referred to as the "Form 1") and focuses on entity size, the select agents on the registration, and other factors. The compliance score is based on past compliance issues, such as suspensions, severe inspection observations, and issues resulting in corrective action plans. The Select Agent Program determined that the registration and compliance scores best capture which entities carry the highest biological safety and security risks and thus are using those scores to prioritize oversight activities moving forward, according to a senior program official.
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| Animal and Plant Health Inspection Service | To improve the ability to perform reviews, the APHIS director of the Select Agent Program should work with CDC to develop and implement 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. (Recommendation 7) |
As of September 2020, the Select Agent Program is determining inspection scheduling and other oversight activities based on risk using a combination of entities' registration and compliance scores, according to agency officials. The registration score is based on entities' registration form (referred to as the "Form 1") and focuses on entity size, the select agents on the registration, and other factors. The compliance score is based on past compliance issues, such as suspensions, severe inspection observations, and issues resulting in corrective action plans. The Select Agent Program determined that the registration and compliance scores best capture which entities carry the highest biological safety and security risks and thus are using those scores to prioritize oversight activities moving forward, according to a senior program official.
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| Centers for Disease Control and Prevention | To improve transparency, the CDC director of the Select Agent Program should work with APHIS to determine what additional information about laboratories' use of select agents, incidents, and violations of the select agent regulations is appropriate for the program to share with registered laboratories. (Recommendation 8) |
The Select Agent Program stated in May 2018 that CDC and APHIS had jointly determined that the following information is appropriate to share with registered laboratories: (1) common regulatory departures identified during inspections, their causes, and recommended corrective actions; (2) common equipment failures; and (3) best practices gleaned from the registered communities. The program plans to incorporate this information into a public report that will be distributed in a number of ways, including through the Select Agent Program website, industry publications, and presentations at industry conferences and other meetings, according to the Select Agent Program.
|
| Animal and Plant Health Inspection Service | To improve transparency, the APHIS director of the Select Agent Program should work with CDC to determine what additional information about laboratories' use of select agents, incidents, and violations of the select agent regulations is appropriate for the program to share with registered laboratories. (Recommendation 9) |
The Select Agent Program stated in May 2018 that CDC and APHIS had jointly determined that the following information is appropriate to share with registered laboratories: (1) common regulatory departures identified during inspections, their causes, and recommended corrective actions; (2) common equipment failures; and (3) best practices gleaned from the registered communities. The program plans to incorporate this information into a public report that will be distributed in a number of ways, including through the Select Agent Program website, industry publications, and presentations at industry conferences and other meetings, according to the Select Agent Program.
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| Centers for Disease Control and Prevention | To improve technical expertise and overcome fragmentation, the CDC director of the Select Agent Program should work with APHIS to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 10) |
CDC agreed with this October 2017 recommendation and, in response, CDC and APHIS conducted joint assessments of workforce and training needs for the Select Agent Program. Specifically, in December 2017, the program conducted an assessment of training needs and, in September 2020, developed a joint 12-course training program for new inspectors and a joint 6-course training program for experienced inspectors based on the assessment, according to program documents and officials. In addition, as of October 2019, APHIS had performed a joint workforce assessment focused primarily on inspections, according to officials. The Select Agent Program has also conducted other assessments covering aspects of the program's workforce, according to program documents and officials. In particular, starting in 2019, the program has used its new information technology system, eFSAP, to identify workforce needs and move staff around as appropriate. With these assessments of workforce and training needs, the Select Agent Program is now able to better manage fragmentation by improving how it leverages resources, which in turn will help to ensure that all workforce and training needs are met.
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| Animal and Plant Health Inspection Service | To improve technical expertise and overcome fragmentation, the APHIS director of the Select Agent Program should work with CDC to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 11) |
APHIS agreed with this October 2017 recommendation and, in response, CDC and APHIS conducted joint assessments of workforce and training needs for the Select Agent Program. Specifically, in December 2017, the program conducted an assessment of training needs and, in September 2020, developed a joint 12-course training program for new inspectors and a joint 6-course training program for experienced inspectors based on the assessment, according to program documents and officials. In addition, as of October 2019, APHIS had performed a joint workforce assessment focused primarily on inspections, according to officials. The Select Agent Program has also conducted other assessments covering aspects of the program's workforce, according to program documents and officials. In particular, starting in 2019, the program has used its new information technology system, eFSAP, to identify workforce needs and move staff around as appropriate. With these assessments of workforce and training needs, the Select Agent Program is now able to better manage fragmentation by improving how it leverages resources, which in turn will help to ensure that all workforce and training needs are met.
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