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    Subject Term: "High-containment laboratories"

    2 publications with a total of 37 open recommendations
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    9 open recommendations
    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 July 2017, 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 2 to 3 years.
    Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Agriculture should direct APHIS to revise reporting forms to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017.
    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 CDC and NIH to revise reporting forms within their respective areas of oversight to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017. In addition, in August 2016, the National Institutes of Health (NIH) revised its template for reporting incidents subject to the NIH Guidelines to include a specific checkbox for entities to identify incidents that involve incomplete inactivation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2017, United States Department of Agriculture (USDA) officials stated that the department, in coordination with the Department of Health and Human Services (HHS), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, Department of Health and Human Services (HHS) officials stated that the department, in coordination with the United States Department of Agriculture (USDA), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    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 March 2017, 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 2 to 3 years.
    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 by 2020. HHS plans to release the updated manual in 2 to 3 years.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Agriculture should direct APHIS to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Agriculture
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Health and Human Services should direct CDC to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. In addition, the Centers for Disease Control and Prevention worked with the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to develop a policy document that outlines criteria for referring violations to the HHS OIG. One of the criterion for referral is any departure from the select agent regulations that creates a danger to public health and safety. This policy document was finalized in June 2017. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    28 open recommendations
    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 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.
    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 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.
    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 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.
    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 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.
    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 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.
    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: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    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: Department of Energy
    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.
    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: Department of Energy
    Status: Open

    Comments: In August 2016, DOE reported that it is updating its outdated select agent policy and plans to complete this update by the end of July 2017.
    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: Environmental Protection Agency
    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.
    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: Environmental Protection Agency
    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 maintains 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, we have reached out to EPA for documentation of the actions the agency stated it has taken. Until received, we continue to believe that EPA action on this recommendation is still needed, such as by providing an updated EPA-level safety manual that includes a schedule for reviewing and updating, or providing EPA's schedule set in policy, so long as it also applies to agency- or senior office-level 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 Administrator of EPA should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency: Environmental Protection Agency
    Status: Open

    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. ?This is a positive step. We are waiting for EPA to provide us with supporting documentation.
    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. CDC did not provide an anticipated completion date. FDA anticipated completing the policy revisions/updates by summer 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 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.
    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.
    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 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.
    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 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.
    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: Department of the Interior
    Status: Open

    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.
    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: Department of the Interior
    Status: Open

    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.
    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: Department of the Interior
    Status: Open

    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.
    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: Department of the Interior
    Status: Open

    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.
    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: Department of Veterans Affairs
    Status: Open

    Comments: In June 2016, VA reported that while it has policies for reporting laboratory incidents at the local level (VA medical center or laboratory level), VA plans to develop a national level policy for reporting laboratory incidents to senior department officials, including the types of incidents to report, to whom, and when. VA will convene a task force for the purposes of developing such a policy and anticipates that the task force will finalize its policy by March 2018. In June 2017, VA reported that the task force concluded that VA's existing emergency management plan contained all of the necessary requirements for laboratory incident reporting. However, VA has not provided GAO with the emergency management plan. VA further noted that a intradepartmental memorandum was sufficient for making employees aware of such policy requirements in the emergency plan and that such a memorandum was drafted and was being processed for dissemination throughout VA, with an anticipated completion date of August 2017.
    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: Department of Veterans Affairs
    Status: Open

    Comments: VA updated and finalized its outdated policy for its clinical laboratories in February 2016. In July 2016, VA reported that it has begun updating its policies for its research laboratories and anticipated finalizing them in 6 months. In June 2017, VA reported that its policies for its research laboratories remain under review and revision, with an anticipated completion date of December 2017.