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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Highlights
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.
Recommendations
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.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Agriculture | 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. |
In September 2020, the United States Department of Agriculture (USDA) updated its Biorisk Management Policy (Departmental Regulation 4400-007). The departmental policy establishes requirements and responsibilities for administering a comprehensive biorisk management program across the department, including all USDA agencies and laboratories (such as those working with Biological Select Agents and Toxins (BSAT)). Among other things, the policy requires that all laboratory incidents be reported within 2 business days to senior department officials, including the USDA Joint Committee on Biorisk Management Policy (JCBMP) Executive Secretary. The policy also details the types of incidents that should be reported, such as when multiple individuals are exposed to an infectious agent or when significant security breaches (e.g., theft) occur. The revised USDA policy provides assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Agriculture | 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. |
In September 2020, the United States Department of Agriculture (USDA) updated its Biorisk Management Policy (Departmental Regulation (DR) 4400-007). The departmental policy establishes requirements and responsibilities for administering a comprehensive biorisk management program across the department, including all USDA agencies and laboratories working with biological select agents and toxins. Officials stated the departmental policy will expire in September 2025, at which time the policy will be reviewed and updated as needed. As of March 2022, the three USDA agencies in our review-the Agricultural Research Service (ARS), Food Safety and Inspection Service (FSIS), and Animal and Plant Health Inspection Service (APHIS)-have updated their respective biosafety policies. Specifically, in October 2019, ARS updated its agency policy for its institutional biological safety committee, the entity responsible for ensuring biosafety in its laboratories. ARS officials said that in light of this update, the contents of the policy already meet the requirements set by DR 4400-007 (e.g., reporting and investigating any incidents related to biological agents). Officials noted that they plan to update the ARS policy during its next scheduled review cycle in 2024 to include an updated reference to DR 4400-007. In December 2021, FSIS updated its biorisk management agency policy. In March 2022, APHIS updated its biorisk management manual, which establishes a framework of organizational structure, policies, practices, and guidance for ensuring biosafety in its laboratories. In addition, APHIS established a regular review schedule of three years (or earlier as needed) for its biorisk manual. The updated departmental and agency policies provide assurances that USDA and its agencies have stronger oversight mechanisms for managing hazardous biological agents in their high-containment laboratories.
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| Department of Agriculture | 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. |
In September 2021, officials with the United States Department of Agriculture (USDA) said that the department updated its Biorisk Management Policy in September 2020. The policy, which establishes requirements and responsibilities for administering a comprehensive biorisk management program across the department, including all USDA agencies and laboratories. Among other things, the policy requires that all significant incidents and critical inspection findings that would require immediate departmental attention or action be reported within 2 business days to senior department officials, including the USDA Joint Committee of Biorisk Management Policy (JCBMP) Secretary. The USDA Operational Biorisk Subcommittee then reviews these reports, evaluates trends and lessons learned, and shares feedback with individual agencies. The JCBMP is required to share summaries of report findings and evaluation results with senior department officials on an annual basis at a minimum. In October 2021, USDA provided GAO with examples of analysis results from inspection findings and lessons learned shared with USDA JCBMP. The revised USDA policy provides assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Agriculture | 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. |
In September 2020, the United States Department of Agriculture (USDA) updated its Biorisk Management Policy (Departmental Regulation 4400-007). The departmental policy establishes requirements and responsibilities for administering a comprehensive biorisk management program across the department, including all USDA agencies and laboratories (such as those working with BSAT). Among other things, the policy requires that all critical inspection findings that would require immediate departmental attention or action be reported within 2 business days to senior department officials, including the USDA JCBMP Executive Secretary. The JCBMP is required to routinely share summaries of laboratory inspections and incidents with senior department officials. The revised USDA policy provides assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Agriculture | 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. |
In September 2020, the United States Department of Agriculture (USDA) updated its Biorisk Management Policy (Departmental Regulation 4400-007). The departmental policy establishes requirements and responsibilities for administering a comprehensive biorisk management program across the department, including all USDA agencies and laboratories (such as those working with BSAT). Among other things, the policy requires that all laboratory incidents be reported within 2 business days to senior department officials, including the USDA JCBMP Executive Secretary. The revised USDA policy provides assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Defense | 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. |
The Department of Defense (DOD) concurred with our recommendation. DOD officials stated that the department works with three types of biological agents: (1) Biological Select Agents and Toxins (BSAT); (2) Non-BSAT, BSAT-Related (NBBR), which are former BSAT agents that were rendered non-viable through specific procedures; and (3) all other infectious agents and toxins (IAT). DOD Instruction 5210.88-recently updated in May 2020-included inventory control requirements for its BSAT laboratories. DOD also developed an NBBR inventory tracking module-effective in 2017-for its Quality Management System, in which officials can track the inactivation, transfer, or archival of NBBR agents. In addition, DOD Manual 6055.18-recently updated in August 2020-included safety requirements to use, handle, transport, transfer, store, and dispose of IAT in DOD laboratories. The DOD policies and inventory tracking module provide assurances that DOD has stronger oversight mechanisms for managing hazardous biological agents in all DOD and component agency high-containment laboratories.
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| Department of Defense | 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. |
DOD concurred with our recommendation. In January 2019, DOD issued DOD Directive 5101.20E, which establishes policy for the Biological Select Agents and Toxins (BSAT) biosafety and biosecurity program in all DOD BSAT laboratories. In August 2020, DOD updated DOD Manual 6055.18, which establishes responsibilities and safety standards in all DOD non-BSAT laboratories. In addition, in January 2017, Air Force updated its instructions (AFI 10-2611-O) related to its BSAT program. In March 2019, Army updated its regulation (AR 190-17) related to its BSAT security program. The updated DOD, Air Force, and Army policies provide assurances that DOD has stronger oversight mechanisms for managing hazardous biological agents in all DOD and component agency high-containment laboratories.
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| Department of Defense | 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. |
The Department of Defense (DOD) concurred with our recommendation. DOD developed an inspection trending module-which became operational in March 2020-for its Quality Management System. The module is intended to track trends from the analysis of safety data-including inspection results and incident reports-from their high-containment laboratories and allow for the sharing of that information as lessons learned among DOD personnel. In addition to the module, DOD stated that it previously shared lessons learned through quarterly meetings of the Biological Select Agents and Toxins Biorisk and Scientific Review Panel and semiannual stakeholder meetings. The ability to conduct analyses of the safety data and share lessons learned will help senior DOD officials take appropriate measures to improve the management of hazardous biological agents in their high-containment laboratories and to help ensure the safety and security of personnel working in these laboratories.
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| Department of Defense | 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. |
DOD concurred with our recommendation. In August 2020, DOD updated its DOD Manual 6055.18 which, among other things, requires inspection of all active non-select agent laboratories at least semiannually. However, as of September 2021, DOD officials stated that under DOD Instruction 6055.01, which establishes the department's safety and occupational health program, the laboratory commander or director would be the authority to receive reports of workplace inspections and address identified weaknesses. This action by DOD does not fully address our recommendation to routinely report the results of Air Force, Army, and Navy inspections of non-select agent registered laboratories to senior department officials. DOD officials have no further actions planned related to this recommendation. Therefore, we will be closing this recommendation as not implemented.
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| Department of Defense | 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. |
DOD concurred with our recommendation. DOD Manual 6055.18-recently updated in August 2020-establishes safety standards in all DOD non-select agent registered (non-BSAT) laboratories and requires that all laboratory incidents be reported to the appropriate DOD component safety office. In November 2020, DOD officials stated that the highest senior official, to whom non-BSAT laboratory incidents are reported, is within the component service-such as Air Force, Army, or Navy. These incidents are not reported to senior DOD officials because there is no department-level office that oversees non-BSAT agents. Considering DOD's operational structure and assurances of incident reporting requirements to the highest-level officials, we believe that these requirements meet our recommendation and provide assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Defense | 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. |
DOD concurred with our recommendation. Regarding agency inspection results, DOD officials stated that the DOD joint inspection team was established in the fall of 2016 and includes subject matter experts from all DOD components-Army, Air Force, and Navy. Officials said that the joint inspection team reports all inspection results to the Executive Agent Responsible Official (EARO). In January 2019, DOD issued DOD Directive 5101.20E, which formally designates the Secretary of the Army as the DOD EARO for Biosafety and Biosecurity. Further, in May 2020, DOD revised DOD Instruction 5210.88 and required the DOD components to provide an executive summary of significant findings associated with the department-level inspections at select agent (BSAT) facilities to a designated senior department official. Regarding BSAT laboratory inspection results, DOD Directive 5101.20E also requires all BSAT inspection results be reported to the appropriate DOD manager. Officials stated that the "appropriate DOD manager" includes senior agency officials. Further, DOD Instruction 5210.88 also requires the Secretary of the Army to establish an inspection process for BSAT entities that includes joint inspections with the Animal and Plant Health Inspection Service (APHIS) or the Centers for Disease Control and Prevention (CDC)-the two agencies with oversight responsibilities under the federal select agent program. The revised DOD policies provide assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Defense | 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. |
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.
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| Department of Energy | 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. |
As of April 2020, the Department of Energy (DOE) has updated its policy-DOE Policy 434.1B Conduct and Approval of Select Agent and Toxin Work at DOE Sites-to incorporate references to, or requirements for, oversight of high-containment laboratories, including inspections. DOE Policy 434.1B establishes the expectation that DOE's biosafety working group cooperate with the US Department of Health and Human Services and Department of Agriculture in their regulatory oversight of activities conducted in DOE's high-containment laboratories. The policy also references other departmental policies and orders that address oversight responsibilities, including inspections-such as (i) DOE Policy 450.4A Integrated Safety Management Policy, (ii) DOE Order 226.1B Implementation of DOE Oversight Policy, and (iii) DOE Order 450.2 Integrated Safety Management. DOE officials noted that, in accordance with departmental policies and orders, a federal biological safety officer employed by the National Nuclear Security Administration (NNSA) conducts oversight of laboratory activities and that DOE's high-containment laboratories are subject to frequent inspections by the Centers for Disease Control and Prevention and NNSA. The compendium of the updated policy and references to other relevant departmental policies and orders provides assurance that oversight mechanisms, including inspections, are in place for managing hazardous biological agents in high-containment laboratories at DOE.
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| Department of Energy | 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. |
In June 2018, DOE provided us with its updated policy.
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| Environmental Protection Agency | 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. |
In September 2020, EPA issued a new agency-wide policy on biosafety at its high-containment laboratories. The Biosafety Policy incorporates references to, or requirements for, oversight of high-containment laboratories-including inventory control. Specifically, the policy requires that (i) high-containment laboratories use an automated inventory management system to track and monitor usage and final disposition of hazardous biological agents, (ii) laboratory management and biosafety managers check inventory on a quarterly basis and report results to senior agency officials, and (iii) discrepancies be investigated and corrective actions be established. In addition, in September 2020, senior agency officials issued a memo to designate the Biosafety Policy as the Agency's Biosafety Policy for all of its current and future high-containment laboratories. EPA's new Biosafety Policy provides assurances that oversight mechanisms-including inventory control-are in place for managing hazardous biological agents in high-containment laboratories at EPA.
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| Environmental Protection Agency | 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. |
In September 2020, EPA issued an agency-wide policy on biosafety at its high-containment laboratories. The Biosafety Policy incorporates references to, or requirements for, oversight of high-containment laboratories-including a schedule for reviewing and updating EPA policies. Specifically, the Biosafety Policy must be reviewed every three years, if changes are made to the Centers for Disease Control & Prevention's and National Institutes of Health's Biosafety in Microbiological and Biomedical Laboratories guidance document, or if EPA increases high-containment capabilities in any of its laboratories. In addition, in September 2020, senior agency officials issued a memo to designate the Biosafety Policy as the Agency's Biosafety Policy for all of its current and future high-containment laboratories. EPA's new Biosafety Policy provides assurances that oversight mechanisms-including a regular review and update of EPA policies-are in place for managing hazardous biological agents in high-containment laboratories at EPA.
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| Environmental Protection Agency | 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. |
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.
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| Department of Health and Human Services | 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. |
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. In August 2019, FDA reported that it continues to work with the Biosafety and Biosecurity Coordinating Council to establish a process for the routine reporting of these results but had not yet completed its actions. As of October 2020, HHS had not provided an update on the status of CDC's implementation of this recommendation. We will update the status of this recommendation when we receive additional information from HHS.
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| Department of Health and Human Services | 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. |
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 October 2020, CDC issued its High Containment Laboratory Inspection and Reporting Policy, which established requirements related to safety inspections for all CDC high containment laboratories, among other things. The policy states that the agency's Office of Laboratory Science and Safety (OLSS) must inspect all high containment laboratories annually for compliance with safety policies, applicable safety regulations, and best practices. The policy also references and incorporates a separate training policy that requires at least annual training for all CDC employees, including any specialized training for supervisors and employees in high hazard areas such as laboratories-the Workforce Environment, Health, and Safety Training Policy. The CDC policies provide assurances that the department has stronger oversight mechanisms for managing hazardous biological agents in its high-containment laboratories.
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| Department of Health and Human Services | 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. |
The National Institutes of Health (NIH) provided us with its updated policies, which the agency plans to review annually.
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| Department of Health and Human Services | 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. |
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.
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| Department of Health and Human Services | 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. |
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. In September 2020, we reported in GAO-20-594 that, according to FDA officials, the agency is waiting on HHS to establish a process for reporting laboratory inspections to senior HHS officials. As of October 2020, HHS had not provided an update on the status of developing a process for the agencies to report inspection results to senior HHS officials. We will update the status of this recommendation when we receive additional information from HHS.
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| Department of Health and Human Services | 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. |
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 reported safety infractions for the year. In June 2021, FDA reported that its Office of Laboratory Safety planned to perform safety inspections on a triennial basis of all laboratories and on an annual basis of all high containment laboratories, including biological select agents and toxins laboratories, starting in fiscal year 2022. In September 2022, FDA officials provided examples of aggregate inspection findings that had been reported to the FDA Commissioner and the Center Directors and Associate Commissioner for Regulatory Affairs. In May 2024, FDA published an update of its Staff Manual Guides (internal Standard Operating Procedures) that, among other things, memorialized the practice and procedure for annually reporting the aggregate inspection findings and results to these officials. NIH and FDA's actions will help ensure that senior agency officials have greater visibility over safety inspection results, which is important for oversight of their high containment laboratories.
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| Department of Health and Human Services | 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. |
In August 2016, HHS reported that its Biosafety and Biosecurity Council was working to establish incident reporting requirements for CDC, FDA, and NIH but did not provide an anticipated completion date. In September 2020, we reported in GAO-20-594 that while FDA's Office of Laboratory Safety had issued a policy in February 2019 formalizing incident reporting through a centralized reporting system, the policy does not address reporting incidents to senior HHS officials. As of October 2020, HHS had not provided an update on the status of requiring agencies to routinely report incidents to senior HHS officials. We will update the status of this recommendation when we receive additional information from HHS.
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| Department of Health and Human Services | 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. |
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.
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| Department of Homeland Security | 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. |
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.
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| Department of Homeland Security | 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. |
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.
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| Department of the Interior | 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. |
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.
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| Department of the Interior | 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. |
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.
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| Department of the Interior | 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. |
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.
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| Department of the Interior | 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. |
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.
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| Department of Veterans Affairs | 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. |
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. In April 2019, VA provided us with its update policy for managing hazardous biological agents in its high-containment laboratories, which included requirements for hazardous biological agent inventory control.
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| Department of Veterans Affairs | 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. |
VA updated and finalized its outdated policy for its clinical laboratories in February 2016. In April 2019, VA provided GAO with its updated and finalized policy for the department's research laboratories.
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Full Report
GAO Contacts
Marcia Crosse
Topics
Biocontainment laboratoriesBiological agentsHazardous substancesInternal controlsMonitoringReporting requirementsRisk assessmentRisk managementSafety regulationSafety standardsSchedule slippagesStrategic planningPolicies and procedures