Recommendation: To more fully address stakeholder concerns and help ensure FirstNet's resources reflect expected changes in responsibilities, FirstNet should request that the Public Safety Advisory Committee's Tribal Working Group fully explore tribal concerns and propose actions, as needed, to address those concerns.

Agency: Department of Commerce: National Telecommunications and Information Administration: First Responder Network Authority
Status: Open

Comments: As of March 2020, FirstNet had taken some action in response to this recommendation but had not fully implemented it. Once we confirm that FirstNet has taken additional action, we will provide updated information.

Recommendation: The Secretary of the Interior should direct the Assistant Secretary for Land and Minerals Management, who oversees BSEE, to establish a mechanism for BSEE management to obtain and incorporate input from bureau personnel and any external parties, such as Argonne, that can affect the bureau's ability to achieve its objectives.

Agency: Department of the Interior
Status: Open
Priority recommendation

Comments: In its June 9, 2017, response to our report, Interior indicated that BSEE is developing new strategies to improve trust and foster greater collaboration for consideration by the new Director. In September 2018, Interior provided documentation of several BSEE actions, including establishing an Employee Engagement Council, an Innovation Program, and Ombudsman position within the bureau. As of August 2020, BSEE indicated that these efforts remain ongoing. However, this recommendation remains open because BSEE has not yet demonstrated that these actions represent an enduring institutionalization of improved communication throughout the bureau.

Recommendation: The Secretary of the Interior should direct the Assistant Secretary for Land and Minerals Management, who oversees BSEE, to address leadership commitment deficiencies within BSEE, including by implementing internal management initiatives and ongoing strategic initiatives (e.g., Enterprise Risk Management and performance measure initiatives) in a timely manner.

Agency: Department of the Interior
Status: Open

Comments: In its June 2017 response to our report, Interior indicated that BSEE will incorporate lessons learned from its first enterprise risk management cycle in future cycles and that BSEE will incorporate a performance management dashboard in fiscal year 2018. In August 2019, BSEE provided documentation regarding actions it has taken to implement and institutionalize its enterprise risk management and performance measure initiatives. In August 2020, BSEE indicated that implementation of these processes remains ongoing. However, this recommendation remains open because BSEE has not yet demonstrated that these actions represent an enduring institutionalization of improved internal management initiatives and ongoing strategic initiatives throughout the bureau.

Recommendation: The Secretary of the Interior should direct the BSEE Director to address trust concerns that exist between headquarters and the field, BSEE should expand the scope of its employee engagement strategy to incorporate the need to communicate quality information throughout the bureau.

Agency: Department of the Interior
Status: Open

Comments: In its June 2017 response to our report, Interior indicated that BSEE's response to this recommendation would be incorporated into its corrective actions for recommendation one. In September 2018, Interior provided documentation of several BSEE actions, including establishing an Employee Engagement Council, an Innovation Program, and Ombudsman position within the bureau. As of August 2020, BSEE indicated that these efforts remain ongoing. However, this recommendation remains open because BSEE has not yet demonstrated that these actions represent an enduring institutionalization of expanded employee engagement throughout the bureau.

Recommendation: To guide the nation's efforts to improve the federal food safety oversight system and address ongoing fragmentation, the appropriate entities within the EOP should, in consultation with relevant federal agencies and other stakeholders, develop a national strategy that states the purpose of the strategy, establishes high-level sustained leadership, identifies resource requirements, monitors progress, and identifies short- and long-term actions to improve the food safety oversight system.

Agency: Executive Office of the President
Status: Open

Comments: As of March 2020, the Executive Office of the President had not acted on our recommendation. In January 2020, OMB told GAO there were no plans to develop a national strategy on food safety. Instead, OMB said that the administration planned to work toward greater efficiency and interagency coordination within the framework provided by the FDA Food Safety Modernization Act.

Recommendation: To improve DOE's ability to evaluate and monitor the effectiveness of policies that call for all organizations, including contractors, to embrace a strong safety culture and create a work environment that encourages a questioning attitude by all employees, the Secretary of Energy should develop and implement an independent evaluation process for routinely and accurately measuring contractor employees' willingness to raise safety and other concerns without fear of retaliation. This process should ensure that an independent third party develops, conducts, and consistently applies the evaluation methodology--which should include safeguards that protect anonymity. The process should also enable DOE to oversee and ensure that appropriate corrective actions are taken in response to evaluation results.

Agency: Department of Energy
Status: Open

Comments: DOE concurred with the recommendation. DOE has developed a plan to analyze tools utilized by site contractors to determine the viability of using the data to monitor the influence of work environment on employees' willingness to raise safety concerns. As of March 2020, DOE had completed assessments of safety culture sustainment tools and drafted a report. According to officials, the draft report is undergoing final review and officials anticipate issuing the report by the end of fiscal year 2020.

Recommendation: To help ensure that the organizational placement and practices of DOE- and contractor- provided Employee Concerns Programs (ECP) do not inhibit contractor employees from raising safety and other concerns, the Secretary of Energy should revise DOE's ECP order and guidance to (1) require that the organizational placement and practices of contractor ECP's do not compromise or impair their independence, (2) clarify the circumstances under which DOE's ECP is permitted to transfer and refer concerns to contractors, and notify or require approval of the contractor employee raising the concern, and (3) provide criteria for overseeing and evaluating the effectiveness and independence of contractor-provided ECPs.

Agency: Department of Energy
Status: Open

Comments: DOE concurred with the recommendation. DOE issued its revised order on the employee concerns program (ECP) in January 2019. However, that order did not address all three issues raised in our recommendation. Specifically, the order states that it is a best practice for contractor ECP managers to report to a designated executive in the contractor management chain, but does not include information on concerns of independence. Additionally, there is instruction that ECP managers must assess programs and how often, but there is not specific criteria for overseeing and evaluating effectiveness or independence. As of May 2020, we are continuing to discuss these issues with DOE officials.

Recommendation: To help ensure that Congress has the information it needs as it considers whether or not to make permanent the enhanced whistleblower pilot program and that DOE has assurance that contractor employees have an effective mechanism to seek remedy for unlawful retaliation, the Secretary of Energy should fully evaluate the extent to which the pilot program has been implemented and whether its provisions will mitigate challenges associated with DOE's 708 program. This evaluation should include, at a minimum, an assessment of (1) contractors that have adopted the pilot program and the date they did so; (2) contractors that have not adopted the pilot program and an explanation of why not; (3) cases filed under the pilot program, if any; and (4) the pilot program's potential for mitigating challenges associated with the 708 program.

Agency: Department of Energy
Status: Open

Comments: DOE concurred in principle with the recommendation. In response, the Office of Hearings and Appeals conducted a review of the Part 708 program that addressed three of the four items identified in the recommendation. As of May 2020, we are continuing to work with DOE on whether or how it plans to assess the contractors that have adopted the pilot program and the date they did so.

Recommendation: To help improve DOE's ability to take enforcement action against unlawful retaliation when appropriate and take action against contractors that create a chilled work environment, the Secretary of Energy should revise DOE's Integrated Safety Management policy and guidance to clarify what constitutes evidence of a chilled work environment and define the appropriate steps DOE should take to hold contractors accountable for creating a chilled work environment.

Agency: Department of Energy
Status: Open
Priority recommendation

Comments: DOE concurred with the recommendation. In January 2018, DOE issued a revision to DOE Policy 450.4A. The revised policy states that organizations should foster a culture that allows employees to "feel free to raise safety concerns without fear of retaliation...and supporting a questioning attitude concerning safety by all employees." However, the policy does not define the appropriate steps DOE should take to hold contractors accountable for creating a chilled work environment. As of May 2020, we are continuing to work with DOE to determine whether they plan to make additional changes to the policy to address our recommendation.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018, the agency described the actions of committees developed by each of the centers to oversee their regulatory science activities. In July 2019, the agency indicated that it was revisiting its strategic regulatory science priorities as part of its cyclical strategic planning process, and the centers and various offices have taken steps to address the recommendation. In an August 2020 written response, the agency reported that a committee had undertaken a review its 2011 regulatory science strategic plan that will result in the issuance of an accountability framework--an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. FDA reported that its goal was to complete this work by the end of December 2020. However, FDA still needs to document steps taken by these centers to develop measurable goals, and the agency indicated that the recommendation should remain open. GAO will continue to monitor the implementation of this recommendation.

Recommendation: In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018 and July 2019, the agency described actions taken by each center to better track its regulatory science funding. However, FDA still needed to complete these activities and document that funds are systematically tracked across each of the priority areas. In an August 2020 written response, the agency reported that there continue to be efforts to improve tracking of funds for regulatory science projects in priority areas. Specifically, it described the development of an accountability framework-an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. According to FDA, as part of the internal accountability framework, it will track regulatory science projects. FDA reported that its goal was to complete this work by the end of December 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the 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 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 improve USDA's ability to better understand the economic impacts of unintended mixing of GE and other crops, the Secretary of Agriculture should direct the Administrator of the National Agricultural Statistics Service (NASS) to work with all relevant USDA stakeholders, including APHIS and the Organic Working Group, to determine what additional information should be sought in future organic surveys, such as the costs of reshipping and re-storing shipments rejected because of unintended GE presence, as well as the costs associated with finding new buyers for such shipments.

Agency: Department of Agriculture
Status: Open

Comments: In its August 2016 Statement of Action on our report, USDA did not provide any new information on actions it has taken, if any, to implement this recommendation. For example, there was no indication whether stakeholders internal to the department had continued to meet to discuss the 2014 Organic Survey results and how to move forward with future survey questions to obtain additional data, such as data needed to better understand the economic impacts of unintended mixing with GE crops. As of September 2020, USDA did not have an update regarding the implementation of this recommendation. We will continue to follow up on USDA's efforts.

Recommendation: To improve USDA's ability to better understand the economic impacts of unintended mixing of GE and other crops, the Secretary of Agriculture should direct the Administrator of NASS to include producers, growing identity-preserved crops, in addition to organic producers in USDA's survey efforts.

Agency: Department of Agriculture
Status: Open

Comments: In its August 2016 Statement of Action on our report, USDA did not provide any new information on actions it has taken, if any, to implement this recommendation. We continue to believe that USDA should survey producers growing identity-preserved crops regarding their potential economic losses from unintended GE presence, as is being done for organic producers. As we previously reported, U.S. acreage planted to identity-preserved crops is significantly greater than that planted to organic crops; yet, little is known about the economic costs to identity-preserved farmers of unintended mixing. As of September 2020, USDA did not have an update regarding the implementation of this recommendation. We will continue to follow up on USDA's efforts.

Recommendation: Congress may wish to consider directing DOT to study and provide a report to Congress identifying approaches for extracting, storing, and analyzing electronically collected motor carrier drivers' schedule data, including the potential benefits, privacy, and cost concerns, and options for how such concerns could be mitigated.

Agency: Congress
Status: Open

Comments: As of March 2020, Congress has taken no action to direct DOT to study this matter.

Recommendation: To increase the efficiency and improve the accuracy of the interagency UAC referral and placement process, the Secretaries of Homeland Security and Health and Human Services should jointly develop and implement a documented interagency process with clearly defined roles and responsibilities, as well as procedures to disseminate placement decisions, for all agencies involved in the referral and placement of UAC in HHS shelters.

Agency: Department of Homeland Security
Status: Open
Priority recommendation

Comments: Since our 2015 report, DHS and HHS developed two documents to guide interagency procedures related to the processing of UAC. Specifically, in April 2018, HHS and DHS established a memorandum of agreement regarding information sharing for UAC. Subsequently, on July 31, 2018, DHS and HHS issued a Joint Concept of Operations to memorialize interagency policies, procedures, and guidelines related to the processing of UAC. However, in February 2020, we reported that DHS and HHS officials' indicated that, in practice, the agencies have not resolved long-standing differences in opinion about whether and how agencies are to share information, and what type of information is needed to inform decisions about the care and placement of UAC. In commenting on our draft report, DHS stated that its components are working with HHS to document current information sharing practices, to validate remaining information sharing gaps, and to draft a joint plan between DHS and HHS to ensure that HHS receives information needed to make decisions for UAC. In their comments, HHS officials stated that they intend to reach out to counterparts at DHS in June 2020 to discuss potential periodic updates to the Joint Concept of Operations. In August 2020, DHS informed us that the department is working with HHS to document current information sharing practices, validate gaps, and draft a joint plan between DHS and HHS, among other actions. DHS estimates that it will complete these actions by March 31, 2021. To fully address the recommendation, DHS and HHS should ensure that they have implemented procedures aimed at improving the efficiency and accuracy of the interagency UAC referral and placement process.

Recommendation: To increase the efficiency and improve the accuracy of the interagency UAC referral and placement process, the Secretaries of Homeland Security and Health and Human Services should jointly develop and implement a documented interagency process with clearly defined roles and responsibilities, as well as procedures to disseminate placement decisions, for all agencies involved in the referral and placement of UAC in HHS shelters.

Agency: Department of Health and Human Services
Status: Open
Priority recommendation

Comments: Since our 2015 report, DHS and HHS developed two documents to guide interagency procedures related to the processing of UAC. Specifically, in April 2018, HHS and DHS established a memorandum of agreement regarding information sharing for UAC. Subsequently, on July 31, 2018, DHS and HHS issued a Joint Concept of Operations to memorialize interagency policies, procedures, and guidelines related to the processing of UAC. However, in February 2020, we reported that DHS and HHS officials' indicated that, in practice, the agencies have not resolved long-standing differences in opinion about whether and how agencies are to share information, and what type of information is needed to inform decisions about the care and placement of UAC. In commenting on our draft report, DHS stated that its components are working with HHS to document current information sharing practices, to validate remaining information sharing gaps, and to draft a joint plan between DHS and HHS to ensure that HHS receives information needed to make decisions for UAC. In their comments, HHS officials stated that they intend to reach out to counterparts at DHS in June 2020 to discuss potential periodic updates to the Joint Concept of Operations. In August 2020, DHS informed us that the department is working with HHS to document current information sharing practices, validate gaps, and draft a joint plan between DHS and HHS, among other actions. DHS estimates that it will complete these actions by March 31, 2021. To fully address the recommendation, DHS and HHS should ensure that they have implemented procedures aimed at improving the efficiency and accuracy of the interagency UAC referral and placement process.

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 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.

Recommendation: To better position EPA to collect chemical toxicity and exposure-related data and ensure chemical safety under existing TSCA authority, while balancing its workload, and to better position EPA to ensure chemical safety under existing TSCA authority, the Administrator of EPA should direct the appropriate offices to develop strategies for addressing challenges that impede the agency's ability to meet its goal of ensuring chemical safety. At a minimum, the strategies should address challenges associated with: (1) obtaining toxicity and exposure data needed to conduct ongoing and future TSCA Work Plan risk assessments, (2) gaining access to toxicity and exposure data provided to the European Chemicals Agency, (3) working with processors and processor associations to obtain exposure-related data, (4) banning or limiting the use of chemicals under section 6 of TSCA and planned actions for overcoming these challenges--including a description of other actions the agency plans to pursue in lieu of banning or limiting the use of chemicals, and (5) identifying the resources needed to conduct risk assessments and implement risk management decisions in order to meet its goal of ensuring chemical safety.

Agency: Environmental Protection Agency
Status: Open
Priority recommendation

Comments: As of March 2020, several sections of this recommendation have been superseded by the Frank R. Lautenberg Chemical Safety for the 21st Century of 2016. However, questions remain about whether the Office of Chemical Safety and Pollution Prevention, which oversees implementation of this legislation, has identified the resources necessary to conduct risk assessments and implement risk management decisions.

Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should implement cost-effective usability improvements to SaferProducts.gov, taking into account the results of any existing usability testing or any new testing CPSC may choose to conduct.

Agency: Consumer Product Safety Commission
Status: Open

Comments: The Commission has taken some steps to address this recommendation by making usability improvements to SaferProducts.gov that we identified in our consumer testing in our report. For example, in 2015, the Commission addressed issues identified with the search functionality of the website by improving the advanced search function to enable searches by injury, time period, and location. In August 2018, the Commission clarified the purpose of SaferProducts.gov by adding the tagline (brief text that gives users an immediate idea of what the site does) "Report. Search. Protect." to its website. As of August 2019, CPSC has explored further ways to improve the usability of SaferProducts.gov. Specifically, in February 2019, CPSC published a request for information from the public on how to improve SaferProducts.gov. In March 2019, CPSC held a public hearing to obtain a feedback on how the design of SaferProducts.gov and process of submitting safety reports could be improved. For example, two consumer groups recommended that CPSC further improve the website's search function to yield more relevant and streamlined results and that it be designed for better use on mobile devices. Based on this input, CPSC is in the process of developing a plan for re-designing SaferProducts.gov using modern web-design standards, which includes improving the website's layout and styling, search capabilities, and functionality on mobile devices. According to CPSC, its staff plans to explore cost-effective resources to assess usability and identify further improvements to the website, such as coordinating with the General Services Administration on the design aspects of SaferProducts.gov and using other federal best practices to inform this process. However, no such cost-effective changes have yet been made to the website. According to officials, CPSC plans to begin this re-design in 2019 or 2020 pending available future funding. Until the Commission fully addresses this recommendation, it remains open. We will continue to monitor the Commission's progress in implementing our recommendation.

Recommendation: To enhance FAA's efforts to improve general aviation safety, the Secretary of Transportation should direct the FAA Administrator to improve measures of general aviation activity by requiring the collection of the number of hours that general aviation aircraft fly over a period of time (flight hours). FAA should explore ways to do this that minimize the impact on the general aviation community, such as by collecting the data at regular events (e.g., during registration renewals or at annual maintenance inspections) that are already required.

Agency: Department of Transportation
Status: Open

Comments: In July 2019, GAO confirmed that FAA still does not plan to collect General Aviation (GA) flight hour data during registration renewals or annual maintenance inspections because this would require rulemaking and could have a significant economic and paperwork impact on the GA industry. While FAA has made changes to the GA Activity Survey to improve the accuracy of the flight hour data collected for a sample of GA populations, FAA still does not plan to collect all GA flight hour data as part of its GA Activity Survey. GAO maintains that without comprehensive GA flight hour data, estimates from the GA Activity Survey may not be sufficient for drawing conclusions about changes in crash rates over time and that more precise flight hour data could allow FAA to better target its safety efforts within the GA industry.

Recommendation: To enhance FAA's efforts to improve general aviation safety, and to ensure that ongoing safety issues are addressed, the Secretary of Transportation should direct the FAA Administrator to set specific general aviation safety improvement goals--such as targets for fatal accident reductions--for individual industry segments using a datadriven, risk management approach.

Agency: Department of Transportation
Status: Open

Comments: In July 2019, GAO confirmed that FAA still does not plan to develop safety targets for different segments of the General Aviation (GA) industry. While FAA's General Aviation Joint Steering Committee was exploring metrics for monitoring different GA industry segments, it was determined that developing credible metrics was not feasible using the GA Activity Survey. GAO maintains that FAA needs to develop specific general aviation safety improvement targets for individual industry segments to support a data-driven, risk management approach.

Recommendation: To enhance FAA's efforts to improve general aviation safety, and to determine whether the programs and activities underlying the 5-year strategy are successful and if additional actions are needed, the Secretary of Transportation should direct the FAA Administrator to develop performance measures for each significant program and activity underlying the 5-year strategy.

Agency: Department of Transportation
Status: Open

Comments: FAA reported it established performance measures for significant programs and activities underlying its 5-year strategy. However, as of July 2019 FAA has still not provided GAO with documentation of these performance measures. Without this documentation, GAO cannot confirm that the agency has developed performance measures for each significant program and activity underlying its 5-year strategy.

Recommendation: To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products and that overseas office activities are coordinated with the centers and Office of Regulatory Affairs (ORA).

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

Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. Among other things, the agency developed new performance measures for these offices along with a monitoring and evaluation plan and conducted an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In August 2020, the agency indicated that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

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

Comments: On November 16, 2017, FDA published a notification of availability for the draft guidance "Best Practices for Convening a GRAS Panel: Guidance for Industry," with a request for comments on the draft guidance by May 15, 2018. FDA indicated that the draft guidance represents FDA's current thinking on strategies to minimize the potential for conflicts of interest in companies' GRAS determinations, including assessing potential GRAS panel members for conflicts of interest. As of July 2020, FDA had not yet finalized the guidance, so we are leaving the recommendation open.

Recommendation: Because EPA alone cannot address the complexities of the nation's challenges in addressing environmental health risks for children, Congress may wish to consider re-establishing a government-wide task force on children's environmental health risks, similar to the one previously established by Executive Order 13045 and co-chaired by the Administrator of EPA and the Secretary of Health and Human Services. Congress may wish to consider charging it with identifying the principal environmental health threats to children and developing national strategies for addressing them. Congress may also wish to consider establishing in law the Executive Order's requirement for periodic reports about federal research findings and research needs regarding children's environmental health.

Agency: Congress
Status: Open

Comments: As of March 2020, we have not identified actions by the Congress to establish in law requirements such as those in Executive Order 13045.

Recommendation: In order to develop an approach to decision making and the development of evidence on high-clockspeed trends affecting highway safety that are characterized by uncertainty, the Secretary of Transportation should consider and evaluate practices and principles for making decisions under conditions of uncertainty and for using data in such decision making and, on that basis, develop an approach to guide decision making on high-clockspeed trends that, although somewhat uncertain, may affect highway safety.

Agency: Department of Transportation
Status: Open

Comments: In GAO-09-56, GAO recommended the Secretary of Transportation consider and evaluate practices and principles for making conditions under uncertainty and for using data in light of issues encountered in developing evidence on high-clockspeed trends affecting highway safety that are characterized by uncertainty. GAO had studied driver distraction involving electronic devices, in particular cell phones with texting capability and identified these evolving electronic devices as a high clockspeed trend. DOT reports several actions on distracted driving, specifically: (1) an Executive Order to federal employees not to engage in text messaging while driving government-owned vehicles; when using electronic equipment supplied by the government while driving; or while driving privately owned vehicles when they are on official business; (2) the Secretary called on state and local governments to (a) make distracted driving part of their state highway plans, (b) pass state and local laws against distracted driving in all types of vehicles, (c) back up public awareness campaigns with high-visibility enforcement actions; (3) the Secretary directed the Department to establish an on-line clearinghouse on the risks of distracted driving and also (4) pledged to continue the Department's research on how to best combat distracted driving. DOT also notes that the Department's www.distraction.gov website provides information on the latest data on distracted driving and that 34 states have passed laws against texting and driving since the 2009 announcement by the Secretary of DOT.

Recommendation: The Secretary of Transportation should evaluate whether or not new approaches to data collection are needed to better track new trends related to highway safety.

Agency: Department of Transportation
Status: Open

Comments: DOT has not responded to this recommendation.

Recommendation: In order to improve the information available to the Congress for reauthorization, the Secretary of Transportation should analyze and report on trends currently anticipated to affect highway safety through 2020 and beyond in a systematic fashion--including information on high-clockspeed trends, discussion of evidence about these and other individual trends, their implications and potential interactions, and DOT responses.

Agency: Department of Transportation
Status: Open

Comments: DOT has not responded to this recommendation, but DOT announced a distracted driving summit September 30-October 1, 2009, with a limited number of invitees, and invited the GAO Assistant Director on this report to participate. U.S. Transportation Secretary Ray LaHood stated that the purpose of the summit is to "to address the dangers of text-messaging and other distractions behind the wheel." The summit will include "senior transportation officials, elected officials, safety advocates, law enforcement representatives and academics" who will convene in Washington, DC "to discuss ideas about how to combat distracted driving."

Recommendation: In order to improve the information available to the Congress for reauthorization, the Secretary of Transportation should determine, in consultation with relevant congressional committees, schedules for periodic reporting that will be sufficiently frequent to update the Congress on fast-changing trends.

Agency: Department of Transportation
Status: Open

Comments: DOT has not responded to this recommendation.

Recommendation: To provide more efficient, consistent, and effective federal oversight of the nation's food supply, Congress should consider commissioning the National Academy of Sciences or a blue ribbon panel to conduct a detailed analysis of alternative organizational food safety structures and report the results of such an analysis to Congress.

Agency: Congress
Status: Open

Comments: The 2002 Farm Security and Rural Investment Act (2002 Farm Bill) established a national Food Safety Commission charged with making specific recommendations for drafting legislative language. Among other things, the Commission was to make recommendations on how to improve the food safety system, create a harmonized, central framework for managing federal food safety programs, and enhance the effectiveness of federal food safety resources. However, as of January 2017, as far as current staff can ascertain, the Commission was never formed, and no recommendations were ever produced. Thus, although Congress acted to create a food safety commission through legislation, the substance of our matter--recommendations for analyzing alternative food safety structures--was not implemented. GAO subsequently made the same matter for congressional consideration in several later products, and the matter also appeared in the annual GAO Duplication, Overlap, and Fragmentation Report. As of March 2020, it remained unaddressed.