High-Containment Laboratories:

Comprehensive and Up-to-Date Policies and Stronger Oversight Mechanisms Needed to Improve Safety

GAO-16-305: Published: Mar 21, 2016. Publicly Released: Apr 19, 2016.

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Marcia Crosse
(202) 512-7114
crossem@gao.gov

 

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

 

Office of Public Affairs
(202) 512-4800
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What GAO Found

Most of the 8 departments and 15 agencies that GAO reviewed had policies that were not comprehensive, and some departments and agencies had policies that were not up to date. Specifically, policies at 5 departments and 9 agencies were not comprehensive because they did not contain all six elements that GAO identified as key for managing biological agents in high-containment laboratories. These elements are incident reporting, roles and responsibilities, training, inventory control, inspections, and requiring adherence to or referencing leading laboratory safety guidance. Three of the 8 departments and 5 of the 15 agencies did not have policies. In addition, as of December 2015, 2 departments and 5 agencies did not have up-to-date policies. Comprehensive policies that contain all six key elements and that are reviewed and updated regularly would help departments reduce the risk of mismanaging hazardous biological agents and ensure that their policies convey consistent requirements for oversight, reflect current guidance, and address emerging threats.

The departments and agencies GAO reviewed were primarily using inspections to oversee their high-containment laboratories, but some of them were not routinely reporting inspection results, laboratory incidents, and other oversight activities, such as trend analyses, to senior officials. Specifically, 3 of the 8 departments and 13 of the 14 agencies that were operating high-containment laboratories at the time of GAO's review conducted routine laboratory inspections. Of those departments and agencies that routinely inspected laboratories, 1 department and 5 agencies did not conduct trend analyses of inspection results; senior officials at 5 departments and 8 agencies did not routinely receive inspection results; and senior officials at 4 departments did not routinely receive incident reports. These departments and agencies typically did not report this information because there was no requirement for them to do so. Routinely analyzing inspection results and incident reports and sending this information to senior officials—consistent with federal internal control standards for monitoring—would help them identify laboratory safety trends, determine whether safety lapses reflect systemic issues, and make necessary improvements.

The Department of Health and Human Services (HHS) and Department of Defense (DOD) had a number of serious laboratory safety lapses in 2014 and 2015 and were making progress in implementing recommendations from the reviews of these lapses. As of November 2015, HHS agencies—the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA)—reported implementing 91 and 6 recommendations, respectively, and were taking steps to implement others, and the National Institutes of Health (NIH) reported implementing all of its recommendations. DOD reported implementing one recommendation from its review and was taking steps to implement others. HHS and DOD have developed plans to track implementation of these recommendations, but CDC's, DOD's, and Army's plans lacked some implementation time frames. Plans that include time frames are consistent with federal internal control standards and leading practices for program management and would give HHS and DOD better assurance that they can implement these recommendations in a timely manner and assess their progress in doing so.

Why GAO Did This Study

Safety lapses at federal high-containment laboratories in 2014 and 2015 raised concerns about federal departments' oversight of these laboratories. These laboratories work with hazardous biological agents to develop measures to protect public and animal health and the food supply against these agents. GAO was asked to review oversight at federal high-containment laboratories.

This report examines (1) the extent to which federal agencies have comprehensive and up-to-date policies for managing biological agents in these laboratories, (2) how they oversee laboratories, and (3) the extent to which HHS and DOD have implemented recommendations from laboratory safety reviews. GAO assessed policies and oversight activities at 8 departments and their 15 component agencies that own and operate high-containment laboratories against federal internal control standards and program management leading practices, reviewed plans for implementing laboratory safety recommendations, and interviewed federal officials.

What GAO Recommends

GAO is making 33 recommendations, including that departments develop and update policies to include missing elements, ensure that oversight activity results are reported to senior officials, and develop plans with time frames for implementing safety recommendations. Six departments generally agreed with all recommendations; two departments stated that no further action was needed for some of them. As discussed in the report, GAO maintains that these actions are needed.

For more information, contact Marcia Crosse at (202) 512-7114 or crossem@gao.gov or John Neumann at (202) 512-3841 or neumannj@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Comments: In October 2016 USDA reported that its science and safety councils chartered a joint biorisk management policy committee to oversee the revisions of existing policies to include department-wide incident reporting requirements and time frames. USDA also reported that FSIS will collaborate with the department to ensure that FSIS policies comply with USDA reporting requirements. USDA did not provide an anticipated completion date for revising departmental polices. As of September 2018, USDA had not provided an update on the status of these policies.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Administrator of the Food Safety and Inspection Service to develop agency policies that contain these requirements.

    Agency Affected: Department of Agriculture

  2. Status: Open

    Comments: In October 2016, USDA reported that the science and safety councils' joint biorisk management policy committee will review and update the existing outdated USDA policies. In addition, USDA reported that APHIS will review agency policies for biological laboratories every 3-5 years or sooner, if necessary, and that this schedule will be reflected in USDA policy. USDA did not provide an anticipated completion date for reviewing and updating departmental polices. USDA reported that ARS has finalized its policies for its institutional biological safety committee in April 2016. Once all USDA and component agency policies have been updated and review schedules established, we will close this recommendation. As of September 2018, USDA had not provided an update on the status of these policies.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should review and update outdated department policies for managing hazardous biological agents in high-containment laboratories and direct the Administrators of the Animal and Plant Health Inspection Service (APHIS) and Agricultural Research Service to update their policies and, in the case of APHIS, establish a regular review schedule.

    Agency Affected: Department of Agriculture

  3. Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to collect and analyze laboratory inspection and incident reports and share these reports and critical analyses with USDA senior leadership. USDA did not provide an anticipated start date for analyzing reports and sharing analyses with senior departmental officials. USDA stated that the joint biorisk committee also serves as an information-sharing platform across USDA agencies and, as such, is positioned to share lessons learned from analyses of inspection and incident reports with laboratory personnel as necessary. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing inspection and incident report analyses. As of September 2018, USDA had not provided an update on whether the department has begun analyzing reports and sharing analyses with senior department officials.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should routinely analyze results of the department's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel.

    Agency Affected: Department of Agriculture

  4. Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to revise existing departmental regulations to include requirements for routine reporting of inspection results to senior USDA officials. USDA did not provide an anticipated completion date for revising existing departmental regulations. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing reporting of inspection results or revisions of agency policies to require such reporting. As of September 2018, USDA had not provided an update on the status of the revised departmental regulation.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency Affected: Department of Agriculture

  5. Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to revise existing departmental regulations to include requirements for routine reporting of laboratory incidents to senior USDA officials. USDA did not provide an anticipated completion date for revising existing departmental regulations. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing incident reporting or revisions of agency policies to require such reporting. As of September 2018, USDA had not provided an update on the status of the revised departmental regulations.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of incidents at agency laboratories to senior department officials.

    Agency Affected: Department of Agriculture

  6. Status: Open

    Comments: DOD concurred with our recommendation. As of June 2018, DOD stated that it had completed evaluation of existing DOD and service level guidance related to inventory control. DOD also stated that it will continue to analyze the adequacy of existing policy and the need to expand that policy across the DOD Lab Enterprise as the draft Department of Defense Manual 6055.18 is finalized for publication. DOD provided an estimated completion date of October 2018 for both the update of the manual and the analysis of the need for expansion of inventory control requirements across the DOD Lab Enterprise.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control for all of DOD's high-containment laboratories, not just for its select agent-registered laboratories, or direct the Secretaries of the Air Force, Army, and Navy to revise their existing, respective policies to contain these requirements.

    Agency Affected: Department of Defense

  7. Status: Open

    Comments: DOD concurred with our recommendation. As of July 2018, Army and Air Force policies had been updated, but the Army policy had not yet been published, according to DOD officials. Specifically, DOD stated that it had updated the Air Force policy (AF Instruction 10-2611-0) as of January 19, 2017; this document updates the biological safety standards used in AF labs and implements the draft update to Department of Defense Manual 6055.18M: Safety Standards for Microbiological and Biomedical Laboratories. As of July 18, 2018, Army policy AR 190-17 was complete and the document was awaiting formal publication.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should direct the Secretaries of the Air Force and Army to review and update their respective outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency Affected: Department of Defense

  8. Status: Open

    Comments: DOD concurred with our recommendation. As of June 2018, DOD stated that a draft directive, DODD 5101.XXE, will formally designate the Executive Agent Responsible Official for Biosafety and Biosecurity and establish roles and responsibilities, including a role for analyzing inspection results and incident reports. This draft directive is expected to be finalized in October 2018. In addition, DOD expects to develop a quality management system for tracking trends and sharing lessons learned by September 2018. DOD stated that it had previously established methods for sharing lessons learned, including through quarterly meetings of the BSAT Biorisk and Scientific Review Panel and semiannual stakeholder meetings.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should routinely analyze agencies' inspection results and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel, or direct the Secretaries of the Army and Navy to do so.

    Agency Affected: Department of Defense

  9. Status: Open

    Comments: DOD concurred with our recommendation. As of June 2018, DOD stated that all existing service policies addressing non-select agent registered laboratories require reporting of inspection results to the appropriate authorities in their commands. DOD stated that the draft Department of Defense Manual 6055.18, which updates the Department of Defense Manual 6055.18M: Safety Standards for Microbiological and Biomedical Laboratories, is expected to be finalized for publication in October 2018 and will complete its actions. .

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should require routine reporting of the results of Air Force, Army, and Navy inspections of non-select agent registered laboratories to senior department officials.

    Agency Affected: Department of Defense

  10. Status: Open

    Comments: DOD concurred with our recommendation. As of June 2018, DOD stated that all existing service policies addressing non-select agent registered laboratories require reporting of laboratory incidents to the appropriate authorities in their commands. DOD stated that the draft Department of Defense Manual 6055.18, which updates the Department of Defense Manual 6055.18M: Safety Standards for Microbiological and Biomedical Laboratories, is expected to be finalized for publication in October 2018 and will complete its actions.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should require routine reporting of laboratory incidents at Air Force, Army, and Navy non-select agent registered laboratories to senior department officials.

    Agency Affected: Department of Defense

  11. Status: Open

    Comments: DOD concurred with our recommendation. As of June 2018, DOD stated that the draft directive DODD 5101.XXE, which is expected to be published in October 2018, formally designates the Executive Agent Responsible Official for Biosafety and Biosecurity and will establish roles and responsibilities including a role for reporting inspection results. Further, DOD stated that all inspection results of a joint inspection team are provided to the Executive Agent Responsible Official, and that the joint inspection team was established in September 2016.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should direct the Secretaries of the Army and Navy to require reporting of agency and select agent laboratory inspection results to senior agency officials.

    Agency Affected: Department of Defense

  12. Status: Closed - Implemented

    Comments: DOD concurred with our recommendation. As of June 2018, DOD provided GAO with documentation that it had developed estimated completion dates, or had actual completion dates, for each of the 19 specific recommendations from the July 2015 review. According to DOD, actual completion dates for 9 of the 19 activities ranged from January 2016 to April 13, 2018. The remaining 10 activities had estimated completion dates through September 2018.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should develop time frames for the 19 specific recommendations from the July 2015 review, or direct the Secretary of the Army to do so.

    Agency Affected: Department of Defense

  13. Status: Open

    Comments: In August 2016, DOE reported that it is revising department policy for its select agent and toxin work to highlight oversight of facilities working with these agents and toxins. DOE will solicit input from NNSA, the Office of Science, and its biosurety executive team to determine if specific inspection requirements should be included in the select agent, or other department or agency policies. DOE provided us with information as to other department policies and regulations that allow for inspections. DOE plans to complete its efforts by the end of July 2017. We maintain that DOE should make laboratory inspection requirements explicit and that these requirements apply to all high-containment laboratories, not just those registered with the select agent program. Since August 2016, DOE has not provided us with any revised policy for inspections for all high-containment laboratories. In June 2018, DOE provided us with an overview of its integrated safety management, which the department stated aims to integrate safety "into all work, for all activities at all levels" and a list of department policies, procedures, regulations, and guidance documents that comprise its oversight and safety framework. DOE maintains that its oversight programs are designed and conducted commensurate with the level of risk of the activities and that higher priority and greater emphasis are given to oversight of activities with potentially high consequences. Based on DOE's assertion regarding high-risk activities, we continue to emphasize that DOE should make inspections of all high-containment laboratories explicit in its policies, as it has done with the other five elements we identified as key to managing hazardous biological agents in high-containment laboratories in our 2016 report.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Energy should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inspections, or direct the Administrator of the National Nuclear Security Administration and the Director of the Office of Science to develop agency policies that contain this requirement.

    Agency Affected: Department of Energy

  14. Status: Closed - Implemented

    Comments: In June 2018, DOE provided us with its updated policy.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Energy should review and update its outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency Affected: Department of Energy

  15. Status: Open

    Comments: EPA agreed with this recommendation in its February 2016 comments on the draft report, but maintains that agency, or senior-level policies, exist that include this requirement. EPA officials cited a Microbiology Laboratory Branch standard operating procedure (SOP) as containing inventory control requirements for the agency's one high-containment laboratory. However, in July 2016, EPA officials told us that it disagreed with our assessment that the SOP, as a laboratory-level document, was insufficient to meet our expectations for senior-level policies. In November 2016, EPA officials reiterated its position stating that the SOP had been approved by senior agency management and, as the requirements in it are universally applied by all laboratory staff, appropriately represents an agency-level policy. EPA further noted that the Office of Pesticide Policy, in which the Microbiology Laboratory Branch is located, is a sub-office within EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), an Assistant Administrator-level office. We continue to believe that senior-level policies--in this case, either those policies issued at the EPA level or at the OCSPP/OPP level--that include all of the policy elements we analyzed reflect critical management commitment to and support for a culture of laboratory safety throughout the organization, regardless of the number of agency laboratories. According to EPA officials, in 2017 EPA initiated activities to create an agency-wide Biosafety & Biosecurity Advisory Board (BBAB) as part of the Homeland Security Collaborative Network (HSCN). These activities are being led by EPA's Office of Research and Development and Office of Homeland Security. This program, described as comprehensive and robust, was expected to provide oversight and ensure a culture of responsibility for life sciences research at EPA. As of May 2018, OCSPP reported that it had no updates on the activities of the BBAB.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of the Environmental Protection Agency (EPA) should revise existing EPA policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control, or direct the Director of the Office of Pesticide Programs to incorporate this requirement into its policy.

    Agency Affected: Environmental Protection Agency

  16. Status: Open

    Comments: In July 2016, EPA reported that the policies and procedures for both the facility that houses its microbiology laboratory and the laboratory itself are reviewed and updated on a bi-yearly or yearly basis consistent with the EPA schedules for biosafety and laboratory plans set in policy. However, EPA did not provide us with the policy that sets the EPA schedules. In addition, our analysis focused on policy documents issued by EPA or its senior-level offices, such as EPA's Safety, Health, and Environmental Management Program manual, dated November 2012. When we analyzed that policy for the report, we were unable to determine whether it was up-to-date because it did not include a review and update schedule or a specific recertification date. As of November, 2016, EPA maintained that this recommendation has been completed, because the office revised the standard operating procedure that provides guidance for establishing the receipt, expiration dates, and disposal of biological inventory used in the laboratory. As of April 2017, GAO had reached out to EPA for documentation of the agency's actions. Further, according to EPA officials, in 2017 EPA initiated activities to create an agency-wide Biosafety & Biosecurity Advisory Board (BBAB) as part of the Homeland Security Collaborative Network (HSCN). These activities are being led by EPA's Office of Research and Development and Office of Homeland Security. This program, described as comprehensive and robust, was expected to provide oversight and ensure a culture of responsibility for life sciences research at EPA. As of May 2018, OCSPP reported that it had no updates on the activities of the BBAB.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of EPA should review and update EPA's outdated policies for managing hazardous biological agents in high-containment laboratories and establish a regular schedule for reviewing and updating EPA and Office of Pesticide Programs policies.

    Agency Affected: Environmental Protection Agency

  17. Status: Closed - Implemented

    Comments: EPA agreed with this recommendation in its February 2016 comments on the draft report. In July 2016, EPA reported that its high-containment laboratory will notify senior officials within 3 weeks of any laboratory inspection findings. In November 2017, OCSPP/OPP provided documentation to GAO representing reporting of a select agent inspection within the 3-week time frame. In September 2018, OCSPP provided documentation of regular reports to senior officials about non-select agent, EPA-specific inspections that had been carried out. Officials noted that EPA's Safety, Health, and Environmental Management group inspects the agency's high-containment laboratory every 3 years, and conducted an inspection in 2018.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of EPA should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency Affected: Environmental Protection Agency

  18. Status: Open

    Comments: In August 2016, HHS reported that both CDC and FDA were working to incorporate incident reporting requirements and time frames into formal agency policies and practices but did not provide an anticipated completion date. In summer 2017, CDC and FDA reported that they were continuing to incorporate incident reporting, which includes all laboratory incidents, accidents, injuries, infections, and near-misses, into formal agency policies. FDA anticipated completing the policy revisions/updates by summer 2018. In December 2017, HHS reported that CDC's policies were in the initial stages of the clearance process and anticipated they would be finalized in fall 2018. As of September 2018, HHS had not provided an update on the status of these policies.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Director of CDC and the Commissioner of FDA to incorporate these requirements into their respective policies.

    Agency Affected: Department of Health and Human Services

  19. Status: Open

    Comments: In August 2016, HHS reported that CDC plans to revise its policies to include training and inspection requirements for inspections for all high-containment laboratories but did not provide an anticipated completion date. In June 2017, HHS reported that CDC was in the process of revising its formal policies to ensure they included requirements for training and inspections for all of the agency's high-containment laboratories but did not provide an anticipated completion date. In December 2017, HHS reported that CDC's policies were in the initial stages of the clearance process and anticipated they would be finalized in fall 2018. As of September 2018, HHS had not provided an update on the status of these policies.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for training and inspections for all high-containment component agency laboratories and not just for their select-agent-registered laboratories; or direct the Director of CDC to provide these requirements in agency policies.

    Agency Affected: Department of Health and Human Services

  20. Status: Closed - Implemented

    Comments: The National Institutes of Health (NIH) provided us with its updated policies, which the agency plans to review annually.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should direct the Director of NIH to review and update the agency's outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency Affected: Department of Health and Human Services

  21. Status: Closed - Implemented

    Comments: In August 2017, HHS provided us with FDA's policy for managing hazardous biological agents in high-containment laboratories. This policy states that FDA will review all occupational safety and health discrepancy reports annually to determine if the policy is in need of revision.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should direct the Commissioner of FDA to establish a regular schedule for reviewing and updating agency policies for managing hazardous biological agents in high-containment laboratories.

    Agency Affected: Department of Health and Human Services

  22. Status: Open

    Comments: In August 2016, HHS reported that CDC was working with FDA and NIH to establish a process for notifying HHS leadership of inspection results through the department's Biosafety and Biosecurity Coordinating Council. HHS did not provide us with an anticipated time frame for implementing this notification practice or when the agencies plan to begin notifying HHS of inspection results. As of September 2018, HHS had not provided an update on the status of these actions.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should require routine reporting of the results of agency and select agent laboratory inspections to senior department officials.

    Agency Affected: Department of Health and Human Services

  23. Status: Open

    Comments: In August 2016, HHS reported that FDA is working to establish a process for notifying senior agency officials of inspection results, and in August 2017, FDA reported that it was in the process of updating its policies to reflect such a notification process. FDA anticipated that the updated policies and processes would be in place by summer 2018. In August 2016, HHS reported that NIH's ongoing practice is to report the results of external inspections to senior agency officials and, in May 2016, developed a standard operating procedure that outlines this reporting process. In March 2017, NIH officials provided assurance that its Division of Occupational Safety and Health provides NIH's intramural governing body with information about NIH's safety performance at least annually; officials further assured that this information includes the overall results of annual inspections (or audits, as NIH calls them) of all NIH laboratories and discussion of the top 10 most report safety infractions for the year. GAO considers NIH to have implemented the recommended action. GAO will close the overall recommendation once FDA has taken equivalent, appropriate action. As of September 2018, HHS had not provided an update on the status of FDA'S policies.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should direct the Director of NIH and the Commissioner of FDA to require routine reporting of the results of agency laboratory inspections--and in the case of FDA, require routine reporting of select agent inspection results--to senior agency officials.

    Agency Affected: Department of Health and Human Services

  24. Status: Open

    Comments: In August 2016, HHS reported that its Biosafety and Biosecurity Council is working to establish incident reporting requirements for CDC, FDA, and NIH but did not provide an anticipated completion date. HHS noted that NIH formally adopted a standard operating procedure that lays out the agency's requirements for reporting incidents to senior officials. As of September 2018, HHS had not provided an update on the status of these actions.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should require routine reporting of incidents at CDC, FDA, and NIH laboratories to senior department officials.

    Agency Affected: Department of Health and Human Services

  25. Status: Closed - Implemented

    Comments: In August 2016, HHS reported that CDC is finalizing time frames for laboratory safety recommendations from its internal workgroup review and would share these time frames with us but did not provide an anticipated date for doing so. In June 2014, HHS shared its May 2017 status update of the recommendations, which included time frames for completion for each recommendation.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should direct the Director of CDC to develop time frames for the recommendations from the internal workgroup review.

    Agency Affected: Department of Health and Human Services

  26. Status: Closed - Implemented

    Comments: In August 2016, DHS issued its revised biosafety policies to include requirements for inventory controls that would apply to all laboratories regardless of select agent status.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Homeland Security should revise existing policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control that would apply to all high-containment laboratories, not just select agent-registered laboratories.

    Agency Affected: Department of Homeland Security

  27. Status: Closed - Implemented

    Comments: In August and September 2016, DHS issued its revised biosafety and select agent policies. As part of these revisions, DHS established a regular schedule for reviewing and, as appropriate, updating these policies at least every 3 years.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Homeland Security should review and update its outdated policies for managing high-containment laboratories and establish a regular schedule for reviewing and updating these policies.

    Agency Affected: Department of Homeland Security

  28. Status: Closed - Implemented

    Comments: In July 2016, DOI reported that the Fish and Wildlife Service and U.S. Geological Survey will develop agency-level policies that contain the key elements GAO identified. DOI did not provide us with a time frame for these activities. In late September 2017, the U.S. Geological Survey sent newly-developed agency policies for reporting laboratory incidents and inspection results to senior officials. In August 2018, U.S. Geological Survey officials provided us with a new agency policy that will require the agency's two high-containment laboratories to consult with senior agency officials on their laboratory-specific policies for roles and responsibilities, training requirements, and inventory control. In late September 2017, Fish and Wildlife Service officials told us that they had temporarily closed their only high-containment laboratory, and therefore determined that there was no need to develop policies for managing hazardous biological agents. In May and August 2018 updates, Fish and Wildlife Service officials noted that the agency's high-containment laboratory was in limited use: specifically, that it does not conduct disease research, nor store or work with select agents, and that the laboratory is used very infrequently (2-3 times per year) in an emergency-response capacity only. As part of its accreditation, Fish and Wildlife Service's laboratory has a policy that includes some of the elements we recommended-such as roles and responsibilities, training, and incident reporting. As Fish and Wildlife has restricted the utilization of this laboratory to have a limited role in managing hazardous biological agents, it no longer fits within the scope of GAO's review.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should develop department policies, or direct the Directors of Fish and Wildlife Service and U.S. Geological Survey to develop agency policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials--including the types of incidents that should be reported, to whom, and when--and specific requirements for roles and responsibilities, training, inventory control, and inspections.

    Agency Affected: Department of the Interior

  29. Status: Closed - Implemented

    Comments: In July 2016, DOI reported that its Biosafety Working Group, composed of officials across the department, including Fish and Wildlife Service and U. S. Geological Survey, is developing an automated process for analyzing results of laboratory inspections and incident reports to identify safety and security trends. The working group is also developing a process to share information gleaned from these analyses, including lessons learned, with laboratory personnel in a timely manner. DOI did not provide us with a time frame for these activities. In late September 2017, U.S. Geological Survey officials said that they were working with the Department of Interior's Office of Safety and Health to add specific biosafety inspection questions to the Department's Inspection Abatement System, which would allow the agency to identify any potential trends involving the safety of its high-containment laboratories In August 2018, U.S. Geological Survey officials provided us with the updated Inspection Abatement System questions, including questions specific to biosafety, that will be used as part of fiscal year 2018 audits. In late September 2017, Fish and Wildlife Service officials told us that they had temporarily closed their only high-containment laboratory, and therefore determined that there was no need to develop policies for managing hazardous biological agents. In May and August 2018 updates, Fish and Wildlife Service officials noted that the agency's high-containment laboratory was in limited use: specifically, that it does not conduct disease research, nor store or work with select agents, and that the laboratory is used very infrequently (2-3 times per year) in an emergency-response capacity only. As Fish and Wildlife has restricted the utilization of this laboratory to have a limited role in managing hazardous biological agents, it no longer fits within the scope of GAO's review.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should routinely analyze the results of the agency's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel, or direct the Directors of Fish and Wildlife Service and U.S. Geological Survey to do so.

    Agency Affected: Department of the Interior

  30. Status: Closed - Implemented

    Comments: In July 2016, DOI reported that in according with the reporting requirements it plans to incorporate into agency-level policies in response to our first recommendation, Fish and Wildlife Service and U. S. Geological survey will be required to submit routine or periodic reports of the results of agency and select agent inspections to the department's designated agency safety and health official. In late September 2017, U.S. Geological Survey officials provided GAO with its memo to senior Department of Interior detailing the results of 2017 inspections at its two high-containment laboratories in accordance with the agency-level policy it developed in response to our first recommendation. In September 2017, Fish and Wildlife Service officials told us that they had temporarily closed their only high-containment laboratory, and therefore determined that there was no need to develop policies for managing hazardous biological agents. In May and August 2018 updates, Fish and Wildlife Service officials noted that the agency's high-containment laboratory was in limited use: specifically, that it does not conduct disease research, nor store or work with select agents, and that the laboratory is used very infrequently (2-3 times per year) in an emergency-response capacity only. As Fish and Wildlife has restricted the utilization of this laboratory to have a limited role in managing hazardous biological agents, it no longer fits within the scope of GAO's review.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should require routine reporting of the results of agency and select agent inspections to senior department officials.

    Agency Affected: Department of the Interior

  31. Status: Closed - Implemented

    Comments: In July 2016, DOI reported that the U. S. Geological Survey will modify and expand its existing policies to require reporting of agency and select agent inspection results to senior USGS officials. In late September 2017, U.S. Geological Survey officials provided GAO with documentary evidence of routine reporting of laboratory inspection results to senior agency officials by the agency's two high-containment laboratories, in accordance with the agency-level policy it developed in response to our first recommendation.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should direct the Director of the U.S. Geological Survey to require routine reporting of the results of agency and select agent laboratory inspections to senior agency officials.

    Agency Affected: Department of the Interior

  32. Status: Open

    Comments: In June 2018, VA provided GAO with its handbook on research safety compliance, which contians specific requirements for reporting laboratory incidents to senior VA officials, including the types of incidents to be reported, to whom, and when. VA officials told us that requirements for hazardous biological agent inventory control will be included in its update of its policy for managing hazardous biological agents in high-containment laboratories, which it anticipates finalizing by the end of calendar year 2018.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Veterans Affairs should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials--including the types of incidents that should be reported, to whom, and when--and requirements for inventory control for all of its high-containment laboratories, including its select agent-registered clinical laboratory, or direct the Under Secretary of Health to incorporate these requirements into its policies.

    Agency Affected: Department of Veterans Affairs

  33. Status: Open

    Comments: VA updated and finalized its outdated policy for its clinical laboratories in February 2016. In June 2018, VA reported that its policies for its research laboratories remain under review and revision, with an anticipated completion date of December 2018.

    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Veterans Affairs should direct the Under Secretary of Health to review and update outdated agency policies for managing hazardous biological agents in high-containment laboratories.

    Agency Affected: Department of Veterans Affairs

 

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