Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, resolve agency-wide disagreements on the roles and responsibilities for the centers and OLS in implementing laboratory safety reforms. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, address issues of duplication, overlap, and fragmentation within the safety program. (Recommendation 2)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, identify how FDA leadership will communicate agency-wide on a sustained basis about the importance of laboratory safety and OLS's role in ensuring successful implementation of laboratory safety reforms. (Recommendation 3)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should provide OLS—as FDA's laboratory oversight body—with the necessary oversight authority and access to laboratories to oversee FDA's laboratory safety program and ensure compliance with the agency's laboratory safety policies. (Recommendation 4)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should take steps to assess and mitigate any risks to independence posed by funding OLS—as FDA's laboratory safety oversight body—through the working capital fund. In conducting its risk assessment, FDA should specifically focus on ensuring the decision-making processes of the working capital fund supports OLS's independence and ability to hire sufficient staff to implement its laboratory safety oversight priorities. (Recommendation 5)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Health and Human Services should direct the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to develop clear definitions of inactivation for use within their respective guidance documents that are consistent across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2020, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) within the Department of Health and Human Service (HHS) are taking steps to address this recommendation. Specifically, in January and March 2017, HHS, in collaboration with the United States Department of Agriculture (USDA), issued updated select agent regulations and guidance that included clear definitions of inactivation and a validated inactivation procedure that are consistent across the Federal Select Agent Program. Additionally, HHS stated in December 2016 that NIH will consider providing clear and consistent definitions of inactivation in future guidance that is harmonized with the select agent regulations. Moreover, NIH and CDC told us they plan to include a new appendix in the revised Biosafety in Microbiological and Biomedical Laboratories manual that specifically addresses the development, validation, and implementation of inactivation protocols, which they anticipate releasing in June 2020, according to a CDC official.

Recommendation: To help ensure that inactivation protocols are scientifically sound and are effectively implemented, the Secretary of Health and Human Services should direct CDC and NIH to create comprehensive and consistent guidance for the development, validation, and implementation of inactivation protocols--to include the application of safeguards--across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

Agency: Department of Health and Human Services
Status: Open

Comments: In March 2017, the Department of Health and Human Services (HHS), in collaboration with the United States Department of Agriculture (USDA), issued Federal Select Agent Program guidance on the inactivation of select agents and toxins. According to HHS, this guidance is intended to provide additional information to regulated entities to assist them in meeting new requirements for rendering samples with select agents as non-viable. HHS also stated that the Federal Select Agent Program will continue to work with other federal agencies to ensure that the federal government is addressing inactivation in a consistent manner. In addition, according to HHS, the National Institutes of Health (NIH) will consider providing clear and consistent guidance related to inactivation that is harmonized with the Federal Select Agent Program as appropriate. As of April 2020, NIH and the Centers for Disease Control and Prevention (CDC) were in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses the development, validation, and implementation of inactivation protocols. HHS plans to release the updated manual in June 2020, according to a CDC official.

Recommendation: To help ensure that dangerous pathogens can be located in the event there is an incident involving incomplete inactivation, the Secretary of Health and Human Services should direct the Directors of CDC and NIH, when updating the Biosafety in Microbiological and Biomedical Laboratories manual, to include guidance on documenting the shipment of inactivated material.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) stated in March 2017 that the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) are in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses inactivation methods, including guidance on documenting the shipment of inactivated material. HHS plans to release the updated manual in June 2020, according to a CDC official.

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: Department of Agriculture
Status: Open

Comments: In October 2016, the United States Department of Agriculture (USDA) stated that its Joint Committee on Biorisk Management Policy (JCBMP) would oversee the revisions of existing policies to include department-wide incident reporting requirements and time frames. As of July 2020, USDA estimated that these revisions should be completed by October 2020. Officials stated that updates to component agency policies would be completed shortly after issuance of the departmental policy. We will update the status of this recommendation when we receive additional information.

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: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee the revisions of existing outdated departmental policies. In addition, officials stated that APHIS reviews and updates agency policies every 3-5 years, and that this schedule will be reflected in the updated departmental policy. In October 2019, the Agricultural Research Service (ARS) updated its agency policy for its institutional biological safety committee, the entity responsible for ensuring biosafety in its laboratories. As of July 2020, USDA estimated that revisions to the departmental, APHIS, and Food Safety and Inspection Service (FSIS) policies should be completed by December 2020. We will update the status of this recommendation when we receive additional information.

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: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee efforts to collect and analyze laboratory inspection results and incident reports and share these reports and critical analyses with USDA senior leadership on an annual basis. As of July 2020, USDA estimated that revisions to its departmental policy-which would reflect the JCBMP's role in analyzing inspection results and incident reports, identifying potential trends, and sharing lessons learned-should be completed by October 2020. We will update the status of this recommendation when we receive additional information.

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: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee the revisions of existing policies to include requirements for routine reporting of inspection results to senior USDA officials. In July 2020, USDA estimated that these revisions should be completed by October 2020. We will update the status of this recommendation when we receive additional information.

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: Department of Agriculture
Status: Open

Comments: In October 2016, USDA stated that the JCBMP would oversee the revisions of existing policies to include requirements for routine reporting of laboratory incidents to senior USDA officials. In July 2020, USDA estimated that these revisions should be completed by October 2020. Officials stated that updates to component agency policies would be completed shortly after issuance of the departmental policy. We will update the status of this recommendation when we receive additional information.

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: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. In 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 (DoDM) 6055.18 is finalized for publication. As of August 2019, DoD said the draft DoDM 6055.18 was still in review and the agency estimated it would complete work to respond to this recommendation in February 2020.

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: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. 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 2019, DOD provided GAO with the updated Army policy AR 190-17; however DOD officials stated that as the draft Department of Defense Manual (DoDM) 6055.18 was still undergoing review, this recommendation should remain open. DOD estimated it would complete work to respond to this recommendation in February 2020.

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: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. In August 2019, DOD reported that the Air Force is planning to close its BSAT program by the summer of 2019 and planning was underway to move the Air Force BSAT inventory to another DOD BSAT facility. Additionally, the Army was revising its AR 385-10, which contains biosafety criteria unique to the Army, and estimated the revision would be completed by December 2019. Finally, the draft Department of Defense Manual (DoDM) 6055.18 was still undergoing review, and DOD estimated it would complete work to respond to this recommendation in February 2020.

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: Department of Defense
Status: Open

Comments: DOD concurred with our recommendation. In August 2019, DOD reported that the Air Force is planning to close its BSAT program by the summer of 2019 and planning was underway to move the Air Force BSAT inventory to another DOD BSAT facility. Additionally, the Army was revising its AR 385-10, which contains biosafety criteria unique to the Army, to include a new mishap classification for biosafety mishaps to effect better reporting and analysis of these mishaps, and estimated the revision would be completed by December 2019. Finally, the draft Department of Defense Manual (DoDM) 6055.18 was still undergoing review, and DOD estimated it would complete work to respond to this recommendation in February 2020.

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: Department of Defense
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. As of September 2019, DOD officials had provided updated documentation regarding this recommendation, and GAO was reviewing these updates.

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: Department of Health and Human Services
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. 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 September 2019 we had not received an update from HHS on the status of CDC's implementation of this 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 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: Department of Health and Human Services
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 2019, 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 require routine reporting of the results of agency and select agent laboratory inspections to senior department officials.

Agency: Department of Health and Human Services
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. 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 September 2019, HHS had not provided an update on the status NIH's 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 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: Department of Health and Human Services
Status: Open

Comments: 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 August 2019, FDA reported that the agency began piloting a standardized agency-wide laboratory safety inspection checklist to ensure that all laboratories are inspected rigorously and consistently. As part of the pilot, all laboratories were to be inspected during the first 3 quarters of the calendar year. The agency said it planned to aggregate the results of the inspections, and trends and significant findings would be reported to FDA senior leadership in the fourth quarter of 2019. GAO will continue to monitor FDA's actions to implement this 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 require routine reporting of incidents at CDC, FDA, and NIH laboratories to senior department officials.

Agency: Department of Health and Human Services
Status: Open

Comments: 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. HHS noted that NIH formally adopted a standard operating procedure that lays out the agency's requirements for reporting incidents to senior officials. 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 September 2019, HHS had not provided an update on the status of NIH or CDC actions.