Recommendation: The Director of EPA's Office of Superfund Remediation and Technology Innovation should develop a regular review process to ensure the quality of Superfund Enterprise Management System (SEMS) data identifying NPL sites on tribal property and revise automated reports used to check the accuracy of SEMS data to include on tribal property data. (Recommendation 1)

Agency: Environmental Protection Agency
Status: Open

Comments: EPA concurred with our recommendation. EPA stated that during the course of our work on this report, SEMS tribal data was reviewed for quality control and corrections were made to the existing data. In addition, EPA's Office of Superfund Remediation and Technology Innovation plans to create a schedule to review tribal data in SEMS and disseminate tribal data to Superfund regional coordinators annually for their quality assurance review starting in April 2019.

Recommendation: The Director of EPA's Office of Superfund Remediation and Technology Innovation should clarify agency guidance regarding tribal consultation for the Superfund program to clearly identify the circumstances under which the agency should consider consulting with tribes. (Recommendation 3)

Agency: Environmental Protection Agency
Status: Open

Comments: EPA concurred with our recommendation. EPA plans to issue a memo to regions that clarifies circumstances under which regions may consider tribal consultation for the Superfund program by March 2020.

Recommendation: The Assistant Administrator of EPA's Office of International and Tribal Affairs should develop or revise existing guidance to clearly direct regional officials to document all invitations to consult with tribes in the Tribal Consultation Opportunity Tracking System database and provide the guidance to those officials. (Recommendation 4)

Agency: Environmental Protection Agency
Status: Open

Comments: EPA concurred with our recommendation and planned four actions in response. According to EPA, it (1) issued a memorandum to all Assistant Administrators and Regional Administrators on the importance of tribal consultation in April 2019; (2) plans to issue monthly TCOTS report to Deputy Assistant Administrators and Regional Assistant Administrators on the status of consultations recorded in TCOTS; (3) developed training slides targeted to EPA's Regional Superfund staff on when and how to document consultation actions in TCOTS, presented during the annual 2019 National Association of Remedial Project Managers training in August 2019; and (4) revised a training module and draft TCOTS User Guide with particular emphasis on entering consultation information into TCOTS, with trainings scheduled in 2019.

Recommendation: The Administrator of PHMSA should ensure that PHMSA uses other data and information about budgetary resources as they become available to inform and refine its performance goals. (Recommendation 2)

Agency: Department of Transportation: Pipeline and Hazardous Materials Safety Administration
Status: Open

Comments: As of May 2019, we are following up with PHMSA regarding this recommendation and will provide updated information when we confirm agency actions.

Recommendation: The Assistant Secretary of Labor for Occupational Safety and Health should take additional steps to encourage workers to disclose sensitive concerns during OSHA inspections of meat and poultry plants; for example, by considering additional off-site interviews or exploring other options to obtain information anonymously. (Recommendation 1)

Agency: Department of Labor: Occupational Safety and Health Administration
Status: Open

Comments: OSHA stated that it agrees that workers should be able to report injuries, illnesses, and hazards free of intimidation. OSHA noted that its Field Operations Manual prescribes procedures for facilitating the free and open exchange of information, such as conducting onsite worker interviews without management present. OSHA further stated that when workers indicate interest in offsite interviews, the agency will conduct those interviews as prescribed by the Field Operations Manual. We note in our report that because inspectors inform plant management which workers they want to speak with, supervisors know the identity of workers interviewed onsite. Workers and worker advocates we spoke with expressed concerns about this. OSHA told us that inspectors interview meat and poultry workers offsite infrequently, since these interviews can be challenging and take additional time, and OSHA also may be challenged to find an acceptable venue when the employee is available. In June 2020, DOL informed us that OSHA had signed an alliance with several meat and poultry-related industry associations and that they expect this alliance to help improve overall safety and health for the industry's workers. We continue to believe that there are additional steps OSHA can take to better encourage workers to disclose sensitive concerns, and we look forward to learning how OSHA will draw upon this alliance to help take these steps.

Recommendation: The Assistant Secretary of Labor for Occupational Safety and Health should gather more information, such as by asking workers during meat and poultry plant inspections, to determine the extent to which bathroom access is a problem and how to address any identified issues. (Recommendation 2)

Agency: Department of Labor: Occupational Safety and Health Administration
Status: Open

Comments: OSHA stated that meat and poultry workers should have bathroom access as prescribed by the agency's regulations. They noted that if it is observed that processes indicate lack of bathroom access, or if a worker indicates there is an issue, the agency will investigate. Our report identified a mismatch between the concerns we heard from workers about lack of bathroom access and the problems reported by OSHA. We also reported that workers may not volunteer information about lack of bathroom access unless specifically asked. OSHA may choose to address this issue without routinely asking workers about bathroom access, such as by selectively querying workers based on criteria determined by the agency. In June 2020, DOL informed us that OSHA had signed a national alliance with several meat and poultry-related industry associations, and that bathroom access is one of the topics that will be addressed within this alliance, with a goal of developing educational materials. We note that this is a positive step forward, and we continue to stand by our recommendation.

Recommendation: The Assistant Secretary of Labor for Occupational Safety and Health should update its guidance for employers on how to manage their health units to address the challenges of managing these units. (Recommendation 3)

Agency: Department of Labor: Occupational Safety and Health Administration
Status: Open

Comments: In June 2020, DOL informed us that OSHA continues work on updating its guidance for employers on how to manage their health units to address the challenges of managing these units, and that OSHA anticipates initiating clearance of the draft updated guidance in fall 2020. We will consider closing this recommendation when this effort is complete.

Recommendation: The Assistant Secretary of Labor for Occupational Safety and Health should work with FSIS to assess the implementation of the MOU and make any needed changes to ensure improved collaboration; and set specific timeframes for periodic evaluations of the MOU. (Recommendation 4)

Agency: Department of Labor: Occupational Safety and Health Administration
Status: Open
Priority recommendation

Comments: In February 2020, OSHA reported that OSHA and FSIS drafted an updated MOU, which both parties are reviewing. The two agencies met in Summer 2019 to discuss workplace safety, collaboration between the two agencies, and the implementation of the MOU. During a series of working meetings, they discussed each aspect of the MOU, including training and coordination activities. FSIS and OSHA will continue to meet routinely and review the MOU to determine whether adjustments are needed, as appropriate. We will consider closing this recommendation when this effort is complete.

Recommendation: The FSIS Administrator should work with OSHA to assess the implementation of the MOU and make any needed changes to ensure improved collaboration; and set specific timeframes for periodic evaluations of the MOU. (Recommendation 5)

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open
Priority recommendation

Comments: FSIS stated that it already has directives in place to recognize and report hazards affecting FSIS employees, and acknowledged that the MOU was designed to additionally have FSIS employees report hazards affecting plant employees due to the regular presence of its inspectors in plants. FSIS noted that in collaborating with OSHA, FSIS will need to ensure its primary mission is not compromised by undertaking activities that take time and resources away from its food safety inspection responsibilities. In January 2019, OSHA reported that it met with FSIS several times to discuss chemical exposures, referrals, and issues of jurisdiction in state plan states. FSIS subsequently shared the results from a NIOSH health hazard evaluation that was conducted, as well as the efforts to track the source of the infected birds. To fully implement this recommendation, FSIS should strengthen the MOU and develop a mechanism to regularly evaluate it would help ensure that the goals of the MOU are met; leveraging FSIS's presence in plants provides the federal government with a cost-effective opportunity to protect worker safety and health.

Recommendation: The FSIS Administrator should develop a process to regularly share the worker safety information it collects during its review of new chemicals with FSIS inspectors, plant management, OSHA, and the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (NIOSH). (Recommendation 6)

Agency: Department of Agriculture: Food Safety and Inspection Service
Status: Open

Comments: FSIS stated that the agency already has a process for sharing chemical safety information with its inspectors. However, FSIS has not provided us with evidence that it has shared the worker safety information it collects related to new chemicals, such as safety information that is specific for dilution levels and conditions of use at plants, as noted in the report. FSIS also stated that it would take certain steps to share information about approval of chemicals with other agencies such as OSHA and NIOSH, but the steps identified did not include sharing worker safety information. Incorporating worker safety information would further help enhance this information sharing. FSIS further stated that some of the information collected during its review of new chemicals may be proprietary.

Recommendation: To enhance DOE's ability to make risk-based decisions for the treatment of Hanford supplemental LAW, Congress should consider clarifying, in a manner that does not impair the regulatory authorities of EPA and the state of Washington, DOE's authority at Hanford to determine, in consultation with NRC, whether portions of the supplemental LAW can be managed as a waste type other than high-level waste.

Agency: Congress
Status: Open

Comments: As of March 2020, Congress is continuing to consider whether to implement this Matter.

Recommendation: To help ensure that DOE's treatment of Hanford's supplemental LAW is risk based and cost effective, the Secretary of Energy should develop updated information on the effectiveness of treating and disposing of all the different portions of Hanford's supplemental LAW with alternate methods or at alternate disposal sites, and based on this information, identify potential treatment and disposal pathways for different portions of Hanford's supplemental LAW, considering the risks posed by the LAW. In implementing this recommendation, DOE should take into account the results of the analysis required by Section 3134 of the National Defense Authorization Act for Fiscal Year 2017.

Agency: Department of Energy
Status: Open
Priority recommendation

Comments: As of January 2020, DOE is taking steps to implement GAO's May 2017 recommendation. In 2017, DOE's Office of River Protection contracted with Savannah River National Laboratory, a federally funded research and development center, to evaluate viable treatment options for supplemental low-activity waste. According to DOE, the National Academies of Sciences, Engineering, and Medicine conducted a peer review of that laboratory's evaluation. The laboratory issued a final report in October 2019, and the National Academies issued a final report in late March 2020. According to DOE officials, both reports include information DOE may be able to use in making a decision about treating supplemental low-activity waste. DOE told GAO that they plan to use the studies as scoping documents as they move forward with the decision process. According to DOE officials, as of January 2020, DOE plans to decide how it will treat supplemental low-activity waste by 2026. In addition, in response to GAO's May 2017 recommendation, DOE said it successfully completed the first phase of a project--called the Test Bed Initiative--in December 2017 to demonstrate the feasibility of grouting, transporting, and disposing of three gallons of Hanford's low-activity waste at an alternate disposal site in Andrews, Texas. As of November 2018, DOE was beginning a second phase to demonstrate the feasibility of grouting, transporting, and disposing of 2,000 gallons of Hanford's low-activity waste at the same site in Texas. However, DOE stopped the demonstration project in spring 2019 when it withdrew its permit application for the Test Bed Initiative. According to DOE officials, this was because the State of Washington Department of Ecology (Ecology) proposed that DOE and Ecology engage in negotiations to develop a "holistic and realistic" approach to the retrieval and treatment of Hanford's tank waste. Congressional appropriations committees directed that DOE could spend up to $10 million to continue the Test Bed Initiative in fiscal year 2020, but DOE officials do not have specific plans for resuming the initiative. In October 2018, DOE requested public comment on a new interpretation of the statutory term "high level waste," which if the agency adopts it, could facilitate the use of alternate treatment and disposal methods. The National Defense Authorization Act for Fiscal Year 2020 prohibits DOE from spending its fiscal year 2020 funds on applying this high-level radioactive waste interpretation at Hanford, and as a result, DOE officials stated that DOE does not have near-term plans to use this high-level waste interpretation for supplemental low-activity waste at Hanford. Until DOE develops information that reflects what is now known about the performance of alternate treatment and disposal methods, such as immobilizing tank waste in grout, congressional and agency decision makers will not have access to current scientific information as they decide how to best allocate limited financial resources among many competing needs. Moreover, having updated information on the effectiveness of alternate methods for treating supplemental low-activity waste will help to inform DOE's discussions with the state of Washington.

Recommendation: To help ensure that DOE's treatment of Hanford's supplemental LAW is risk based and cost effective, the Secretary of Energy should have an independent entity develop updated information on the lifecycle costs of treating and disposing of Hanford's supplemental LAW with alternate methods or at alternate disposal sites. In implementing this recommendation, DOE should take into account the results of the analysis required by Section 3134 of the National Defense Authorization Act for Fiscal Year 2017.

Agency: Department of Energy
Status: Open

Comments: As of January 2020, DOE is taking steps to implement GAO's May 2017 recommendation. In 2017, DOE's Office of River Protection contracted with Savannah River National Laboratory, a federally funded research and development center, to evaluate viable treatment options for supplemental low-activity waste. According to DOE, the National Academies of Sciences, Engineering, and Medicine conducted a peer review of that laboratory's evaluation. The laboratory issued a final report in October 2019, and the National Academies issued a final report in late March 2020. According to DOE officials, both reports include information DOE may be able to use in making a decision about treating supplemental low-activity waste. DOE told GAO that they plan to use the studies as scoping documents as they move forward with the decision process. According to DOE officials, as of January 2020, DOE plans to decide how it will treat supplemental low-activity waste by 2026. In addition, in response to GAO's May 2017 recommendation, DOE said it successfully completed the first phase of a project--called the Test Bed Initiative--in December 2017 to demonstrate the feasibility of grouting, transporting, and disposing of three gallons of Hanford's low-activity waste at an alternate disposal site in Andrews, Texas. As of November 2018, DOE was beginning a second phase to demonstrate the feasibility of grouting, transporting, and disposing of 2,000 gallons of Hanford's low-activity waste at the same site in Texas. However, DOE stopped the demonstration project in spring 2019 when it withdrew its permit application for the Test Bed Initiative. According to DOE officials, this was because the State of Washington Department of Ecology (Ecology) proposed that DOE and Ecology engage in negotiations to develop a "holistic and realistic" approach to the retrieval and treatment of Hanford's tank waste. Congressional appropriations committees directed that DOE could spend up to $10 million to continue the Test Bed Initiative in fiscal year 2020, but DOE officials do not have specific plans for resuming the initiative. In October 2018, DOE requested public comment on a new interpretation of the statutory term "high level waste," which if the agency adopts it, could facilitate the use of alternate treatment and disposal methods. The National Defense Authorization Act for Fiscal Year 2020 prohibits DOE from spending its fiscal year 2020 funds at Hanford on this high-level radioactive waste interpretation, and as a result, DOE officials stated that DOE does not have near-term plans to use this high-level waste interpretation for supplemental low-activity waste at Hanford. Until DOE develops information that reflects what is now known about the costs of alternate treatment and disposal methods, such as immobilizing tank waste in grout, congressional and agency decision makers will not have access to current cost information as they decide how to best allocate limited financial resources among many competing needs.

Recommendation: As DOT, in response to the FAST Act, conducts additional evaluation and analysis of ECP brakes and updates the regulatory impact analysis, the Secretary of Transportation should direct FRA and PHMSA to create a plan to collect data from railroads' ongoing and future operational experiences using ECP brakes. The plan should include details on how the agency will work with railroads to collect this data, ensure that such data are reliable, and analyze these data to conduct a retrospective analysis of the ECP brakes requirement that could help inform any potential future actions regarding ECP brakes.

Agency: Department of Transportation
Status: Open

Comments: In December 2017, DOT announced that it would rescind the electronically-controlled pneumatic (ECP) brake rule because its updated Regulatory Impact Analysis estimated that the rule's costs would exceed its benefits. Subsequently, in September 2018, DOT rescinded the ECP brake rule. As a result, DOT confirmed with us in August 2019 that it does not intend to create a plan to collect data from railroads' use of ECP brakes.

Recommendation: As DOT, in response to the FAST Act, conducts additional evaluation and analysis of ECP brakes and updates the regulatory impact analysis, if, based on its updated analysis, DOT promulgates a new rule on the applicable ECP brake system requirements, the Secretary of Transportation should direct FRA and PHMSA to require that freight railroads, once they equip with ECP brakes in response to the requirement, collect and provide data to FRA on their ongoing operational experience with ECP brakes.

Agency: Department of Transportation
Status: Open

Comments: In December 2017, DOT announced that it would rescind the electronically-controlled pneumatic (ECP) brake rule because its updated Regulatory Impact Analysis estimated that the rule's costs would exceed its benefits. DOT subsequently rescinded the ECP brake rule in September 2018. As a result, this recommendation is currently no longer relevant and DOT confirmed with us in August 2019 that it does not plan to implement this regulation.

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

Recommendation: To achieve greater efficiency and effectiveness, Congress should consider transferring the oversight of the markings of toy and imitation firearms in 15 U.S.C. 5001 from the National Institute of Standards and Technology (within the Department of Commerce) to the Consumer Product Safety Commission.

Agency: Congress
Status: Open

Comments: This matter is an action identified in GAO's annual Duplication and Cost Savings reports. No legislative action identified. The Gun Look-Alike Case Act, H.R. 3224, which was introduced on July 27, 2015, in the 114th Congress, would transfer the authority to regulate the markings of toy, look-alike, and imitation firearms in section 5001 of title 15 of the U.S. Code from NIST to CPSC, as GAO suggested in November 2014. This bill was referred to the Subcommittee on Commerce, Manufacturing, and Trade of the Committee on Energy and Commerce in the United States House of Representatives, and did not pass out of committee. This bill was not reintroduced in the 115th Congress and, as of March 2020, has not been reintroduced by the 116th Congress. Continued regulation of the marking of toy and imitation firearms by NIST rather than CPSC does not leverage each agency's expertise and therefore may not be the most efficient use of scarce federal resources.

Recommendation: To improve existing coordination of oversight for consumer product safety, Congress should consider establishing a formal comprehensive oversight mechanism for consumer product safety agencies to address crosscutting issues as well as inefficiencies related to fragmentation and overlap such as communication and coordination challenges and jurisdictional questions between agencies. Different types of formal mechanisms could include, for example, creating a memorandum of understanding to formalize relationships and agreements or establishing a task force or interagency work group. As a starting point, Congress may wish to obtain agency input on options for establishing more formal coordination.

Agency: Congress
Status: Open

Comments: This matter is an action identified in GAO's annual Duplication and Cost Savings reports. As of March 2020, no legislation was identified that would establish a collaborative mechanism to facilitate communication across the relevant agencies and to help enable them to collectively address crosscutting issues, as GAO suggested in November 2014. Some of the agencies with direct regulatory oversight responsibilities for consumer product safety reported that they continue to collaborate to address specific consumer product safety topics. However, without a formal comprehensive oversight mechanism, the agencies risk missing opportunities to better leverage resources and address challenges, including those related to fragmentation and overlap.

Recommendation: To strengthen federal oversight of facilities with ammonium nitrate, the Secretary of Labor and the Administrator of EPA should direct OSHA and EPA, respectively, to consider revising their related regulations to cover ammonium nitrate and jointly develop a plan to require high risk facilities with ammonium nitrate to assess the risks and implement safeguards to prevent accidents involving this chemical.

Agency: Department of Labor
Status: Open

Comments: On December 9, 2013, OSHA issued a Request for Information seeking, among other things, comments on potential revisions to its Process Safety Management standard and its Explosives and Blasting Agents Standard. The Request for Information specifically invited comments on safe work practices for storing, handling, and managing ammonium nitrate and on regulatory requirements to improve its approach to preventing the hazards associated with ammonium nitrate. As of July 2017, OSHA reports it has completed a Small Business Regulatory Flexibility Review Act panel to gather feedback from small businesses on updating its Process Safety Management (PSM) regulation. During the panel, the agency discussed the option of adding ammonium nitrate to the list of chemicals covered by PSM and collected comments. As of June 2018, the PSM rulemaking is on the regulatory agenda under Long Term Action. According to OSHA officials, the agency will continue to collect comments on the option of adding ammonium nitrate to the list of highly hazardous chemicals covered by the PSM regulations as dictated by the rulemaking process. We will close this recommendation when OSHA decides what action to take as a result of the rulemaking process.

Recommendation: To strengthen federal oversight of facilities with ammonium nitrate, the Secretary of Labor and the Administrator of EPA should direct OSHA and EPA, respectively, to consider revising their related regulations to cover ammonium nitrate and jointly develop a plan to require high risk facilities with ammonium nitrate to assess the risks and implement safeguards to prevent accidents involving this chemical.

Agency: Environmental Protection Agency
Status: Open

Comments: In January 2017, EPA issued a final rule to modify its Risk Management Program (RMP) regulations. The agency decided not to propose any revisions to the list of regulated substances and therefore, did not address ammonium nitrate in the revised regulations.

Recommendation: The Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health to consider updating regulations for the storage of ammonium nitrate taking into consideration, as appropriate, other related standards and current practices.

Agency: Department of Labor
Status: Open

Comments: OSHA previously (December 3, 2014) issued guidance to Regional Administrators to assist OSHA officials in enforcing the ammonium nitrate storage requirements in the Explosives and Blasting Agents Standard. In addition, on December 9, 2013, OSHA issued a Request for Information (RFI) seeking, among other things, comments on potential revisions to the Explosives and Blasting Agents Standard, which includes ammonium nitrate storage requirements. According to OSHA officials, the agency discussed the option of adding ammonium nitrate to the list of chemicals covered by the Process Safety Management (PSM) regulations and collected comments. As of June 2018, the PSM rulemaking is on the regulatory agenda under Long-Term Action. We will close this recommendation when the agency decides what action to take as a result of the rulemaking process.

Recommendation: To develop an estimate of the scope of work remaining to address uranium contamination on or near the Navajo reservation, Congress should consider requiring that the Environmental Protection Agency take the lead and work with the other federal agencies to develop an overall estimate of the remaining scope of the work, time frames, and costs.

Agency: Congress
Status: Open

Comments: As of September 2020, we are not aware of any legislation being enacted to address this matter for congressional consideration.

Recommendation: In light of the problems BIA has encountered in managing the cleanup at the Tuba City Dump site, the Secretary of the Interior should direct the Assistant Secretary for Indian Affairs to employ best practices in creating the schedule and cost estimates for the remedial action cleanup phase.

Agency: Department of the Interior
Status: Open

Comments: As of September 2020, BIA and EPA had selected a cleanup option for Tuba City Dump, but BIA had not created schedule or cost estimates for the cleanup action. BIA stated it anticipated completing the cleanup design, which will include cost and schedule estimates, by September 2022. GAO will assess BIA's actions once they are complete.

Recommendation: In light of the problems BIA has encountered in managing the cleanup at the Tuba City Dump site, the Secretary of the Interior should direct the Assistant Secretary for Indian Affairs to identify and examine any lessons learned from managing the remedial investigation and feasibility study contract and consider these lessons as part of the acquisition planning process for the remedial action contract.

Agency: Department of the Interior
Status: Open

Comments: As of September 2020, BIA and EPA had selected a cleanup option for Tuba City Dump, but BIA had not initiated the acquisition planning process for the future cleanup contract. BIA stated it anticipated completing the cleanup design work, including the acquisition package, by September 2022. GAO will assess BIA's actions once they are complete.

Recommendation: To improve the CSA program, the Secretary of Transportation should direct the FMCSA Administrator to revise the SMS methodology to better account for limitations in drawing comparisons of safety performance information across carriers; in doing so, the Secretary of Transportation should direct the FMCSA Administrator to conduct a formal analysis that specifically identifies: (1) limitations in the data used to calculate SMS scores including variability in the carrier population and the quality and quantity of data available for carrier safety performance assessments, and (2) limitations in the resulting SMS scores including their precision, confidence, and reliability for the purposes for which they are used.

Agency: Department of Transportation
Status: Open
Priority recommendation

Comments: FMCSA did not agree with our recommendation, disputing the methodology and conclusions in our report. However, we continue to believe that addressing Safety Measurement System (SMS) methodology limitations has merit and could help the agency better target FMCSA's resources to the carriers that pose the highest risk of crashing. For example, we found FMCSA requires a minimum level of information for a carrier to receive an SMS score; however, this requirement is not strong enough to produce sufficiently reliable scores. As a result, FMCSA identified many carriers as high risk that were not later involved in a crash, potentially causing FMCSA to miss opportunities to intervene with higher risk carriers. To fully implement this recommendation, FMCSA should revise SMS methodology to account for data limitations that limit comparisons so that the FMCSA is better positioned to identify and mitigate carriers that pose the greatest safety risks. FMCSA has recently developed and tested a new methodological approach that could potentially account for the limitations we identified. While FMCSA has not yet committed to deploying the new methodology, they hope to do so some time in 2020.

Recommendation: To improve the CSA program, the Secretary of Transportation should direct the FMCSA Administrator to ensure that any determination of a carrier's fitness to operate properly accounts for limitations we have identified regarding safety performance information.

Agency: Department of Transportation
Status: Open

Comments: The Federal Motor Carrier Safety Administration (FMCSA) agreed with the basic principles that GAO addressed in this area, but disagreed with GAO's characterization of FMCSA's proposed Safety Fitness Determination (SFD) rule. In January 2016, FMCSA issued a notice of proposed rulemaking (NPRM), which proposed a revised methodology for issuance of a safety fitness determination for motor carriers. Specifically, the new methodology would have determined when a motor carrier is not fit to operate commercial motor vehicles in or affecting interstate commerce based on the carrier's on-road safety data; an investigation; or a combination of both. However, in July 2018, in part due to a review of SMS by the National Academies of Science congressionally mandated evaluation of SMS, FMCSA announced that the enhancements previously proposed will not be completed.

Recommendation: To ensure that EPA maximizes its limited resources and addresses the statutory, regulatory, and programmatic needs of EPA program offices and regions when IRIS toxicity assessments are not available, and once demand for the IRIS Program is determined, the EPA Administrator should direct the Deputy Administrator, in coordination with EPA's Science Advisor, to develop an agencywide strategy to address the unmet needs of EPA program offices and regions that includes, at a minimum: (1) coordination across EPA offices and with other federal research agencies to help identify and fill data gaps that preclude the agency from conducting IRIS toxicity assessments, and (2) guidance that describes alternative sources of toxicity information and when it would be appropriate to use them when IRIS values are not available, applicable, or current.

Agency: Environmental Protection Agency
Status: Open
Priority recommendation

Comments: As of February 2020, IRIS program officials indicated that they are building capacity for applying systematic review in chemical assessments. We reported in March 2019 that staff from the IRIS program were communicating more frequently with EPA program and regional offices about program and regional office needs and the IRIS program's ability to meet those needs. While ORD's newly-implemented survey process helps identify a limited number of the highest priority needs for program and regional offices, we also reported in March 2019 that program and regional officials told us that they still need far more chemical assessments than the IRIS program currently produces, and they do not have EPA-wide guidance on what sources to use when IRIS assessments are not available. One program office has developed its own prioritized list of sources for chemical assessments when IRIS assessments are not available, and other offices follow similar guidelines, though none officially. EPA leadership needs to provide documentation showing an agency-wide strategy that includes identifying data gaps and guidance on alternative sources of toxicity information when IRIS values are not available, applicable, or current.