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.

Additional Materials:

Contact:

Timothy M. Persons, Ph.D.
(202) 512-6412
personst@gao.gov

 

John Neumann
(202) 512-3841
neumannj@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 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.

This figure shows a scientist working in a high-containment laboratory.

Additional Materials:

Contact:

Timothy M. Persons, Ph.D.
(202) 512-6412
personst@gao.gov

 

John Neumann
(202) 512-3841
neumannj@gao.gov

 

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

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.

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.

For more information, contact Timothy M. Persons at (202) 512-6412 or personst@gao.gov or John Neumann at (202) 512-3841 or neumannj@gao.gov.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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)

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

  2. Status: Open

    Comments: HHS agreed with this recommendation. 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. This is a positive step towards implementation of this recommendation. However, the procedure does not describe any control activities that will help ensure that the procedure is followed. Once GAO has information on any control activities that the program is implementing to ensure the procedure is followed, GAO will determine if the program has met the intent of the recommendation.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  3. Status: Open

    Comments: USDA agreed with this recommendation. 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. This is a positive step towards implementation of this recommendation. However, the procedure does not describe any control activities that will help ensure that the procedure is followed. Once GAO has information on any control activities that the program is implementing to ensure the procedure is followed, GAO will determine if the program has met the intent of the recommendation.

    Recommendation: 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)

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

  4. Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program was in the process of developing a plan to solicit an external review to assess the potential risks posed by the program's structures within CDC and APHIS.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  5. Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program plans to explore options, including re-examining previous reviews, and assess the need for additional review to ensure potential risks posed by the program's structure are adequately addressed.

    Recommendation: 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)

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

  6. Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program was developing procedures to analyze data in its new information system. In addition, the program plans to provide training to align inspections and other oversight activities to the highest risks. HHS stated that the program expects to complete these activities by June 2018.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  7. Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program plans to develop procedures to analyze data in its new information system to improve the inspection process.

    Recommendation: 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)

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

  8. Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program was developing a plan for disseminating information to registered laboratories. HHS stated that the program expects to complete this plan by March 2018.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  9. Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program is exploring ways to disseminate information on common deficiencies identified during inspections to laboratories registered with the program. In addition, USDA stated that the program plans to analyze data on potential occupational exposures to identify common causes and provide recommendations to prevent future exposures.

    Recommendation: 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)

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

  10. Status: Open

    Comments: HHS agreed with this recommendation and stated in December 2017 that the Select Agent Program planned to complete development of a joint strategic plan and workforce assessment by March 2018.

    Recommendation: 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)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  11. Status: Open

    Comments: USDA agreed with this recommendation and stated in its agency comments on the report, dated September 21, 2017, that the Select Agent Program has initiated contract support to guide the program through development of a joint strategic plan that will include an assessment of workforce and training needs.

    Recommendation: 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)

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

 

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