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    Results:

    Subject Term: "Safety regulation"

    36 publications with a total of 102 open recommendations including 8 priority recommendations
    Director: Susan Fleming
    Phone: (202) 512-2834

    2 open recommendations
    Recommendation: To assess and validate the effectiveness of PHMSA's Risk Ranking Index Model (RRIM) in prioritizing pipelines for inspection, the Secretary of Transportation should direct the Administrator of PHMSA to document the decisions and underlying assumptions for the design of RRIM, including what data and information were analyzed as part of determining each component of the model, such as the threat factors, weights, risk tiers, and inspection frequency.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: To assess and validate the effectiveness of PHMSA's RRIM in prioritizing pipelines for inspection, the Secretary of Transportation should direct the Administrator of PHMSA to establish and implement a process that uses data to periodically review and assess the effectiveness of the model in prioritizing pipelines for inspection and document the results of these analyses.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Mark L. Goldstein
    Phone: (202) 512-2834

    2 open recommendations
    Recommendation: To more fully address stakeholder concerns and help ensure FirstNet's resources reflect expected changes in responsibilities, FirstNet should assess the long-term staffing needs in the Network Program Office prior to requesting to assume full responsibility from Interior for administering the network contract.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Susan Fleming
    Phone: (202) 512-2834

    1 open recommendations
    Recommendation: To leverage and build upon the ongoing efforts within individual DOT modal administrations and to address concerns raised by experts regarding collaboration and coordination, data quality and analytics, regulation development, project delivery processes, and addressing emerging issues, the Secretary of Transportation should: (1) conduct a department-wide review of DOT's current efforts to address these concerns; and (2) develop an action plan with specific steps to implement improvements, as identified, in these areas.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: Gretta L. Goodwin
    Phone: (202) 512-8777

    2 open recommendations
    Recommendation: To help ensure that DOJ is contributing to efforts to improve data collection and service provision to Native Americans, the Director of OVW should require grantees to report the number of human trafficking victims served using grant funding, and, as appropriate, the Native American status of those victims.

    Agency: Department of Justice: Office of Justice Programs: Violence Against Women Office
    Status: Open

    Comments: In responding to a draft of our report, DOJ agreed to require their grantees to report the number of human trafficking victims served, but did not agree to require them to track Native American status of those victims as appropriate, citing victim confidentiality and other reasons. In June 2017, following our report's publication, DOJ provided a status update, reporting that OVW already collects consolidated data on the number of American Indian and Alaska Native victims served who are victims of all crimes and it is in the process of revising grantee forms to collect information on the number of people served who are victims of sex trafficking. We continue to believe that collecting grantee information on both the number and Native American status of victims served is important and will continue to monitor implementation.
    Recommendation: To help ensure that DOJ is contributing to efforts to improve data collection and service provision to Native Americans, the Assistant Attorney General for the Office of Justice Programs should direct OVC and OJJDP to require their grantees to report the number of human trafficking victims served using grant funding, and, as appropriate, the Native American status of those victims.

    Agency: Department of Justice: Office of Justice Programs
    Status: Open

    Comments: In responding to a draft of our report, DOJ agreed to require its grantees to report the number of human trafficking victims served, but did not agree to require them to track Native American status of those victims as appropriate, citing victim confidentiality and other reasons. In June 2017, following our report's publication, DOJ provided a status update, reporting that OJJDP human trafficking grantees will be required to report the number of human trafficking victims served, beginning with progress reports ending December 31, 2017, and that OJJDP will update applicable solicitations beginning in fiscal year 2018 to reflect this new measure. DOJ reported no new efforts from OVC, and maintained that it will not require grantees to report on the Native American status of their victims served using grant funding because of the concerns it cited initially. We continue to believe that collecting grantee information on both the number and Native American status of victims served is important and will continue to monitor implementation.
    Director: Frank Rusco
    Phone: (202) 512-3841

    4 open recommendations
    including 1 priority recommendation
    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. Interior anticipates BSEE taking action by April 30, 2018.
    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 9, 2017 response to our report, Interior indicated that BSEE will incorporate lessons learned from its first ERM cycle in future cycles and that BSEE will incorporate a performance management dashboard in fiscal year 2018. Specific completion dates were not provided.
    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 9, 2017 response to our report, Interior indicated that BSEE's response to this recommendation would be incorporated into its corrective actions for recommendation 1. The target completion date is April 30, 2018.
    Recommendation: The Secretary of the Interior should direct the BSEE Director to increase organizational trust in Integrity and Professional Responsibility Advisor (IPRA) activities, BSEE should assess and amend IPRA guidance to clarify (1) severity threshold criteria for referring allegations of misconduct to the IG and (2) its reporting chain.

    Agency: Department of the Interior
    Status: Open

    Comments: In its June 9, 2017, response to our report, Interior indicated that the BSEE Director will evaluate options for clarifying the roles, responsibilities, and processes for the IPRA. The target date for completion is December 31, 2017.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    1 open recommendations
    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 February 2017, the agency had not acted on our recommendation.
    Director: David C. Trimble
    Phone: (202) 512-3841

    6 open recommendations
    including 1 priority recommendation
    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. In December 2016, the Office of Enterprise Assessments formed a working group to address our recommendations. According to DOE, as of March 2017 the working group developed a strategy and plan to independently analyze data associated with willingness to raise concerns within contractor organizations at DOE sites with high hazard nuclear facilities. We will continue to monitor DOE's efforts to implement this recommendation.
    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. To address this recommendation, DOE planned to update DOE Order 442.1A, Department of Energy Employee Concerns Program, to (1) address the potential for conflicts of interest that could affect the independence of contractor ECPs, (2) clarify the circumstances under which an employee concern can be referred or transferred from a DOE ECP to a contractor ECP, and (3) specify that the processes already identified in DOE Order 226.1B, Implementation of Department of Energy Oversight Policy, be used as part of the oversight processes for contractor-provided ECPs, to include evaluation of their effectiveness and independence. According to DOE, the draft order was affected by a Presidential Memorandum issued in January 2017, which put a temporary stop to the DOE directives process. We will continue to monitor the status of DOE's implementation of this recommendation.
    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 to this recommendation, the Office of Hearings and Appeals conducted a review of the Part 708 program that, according to DOE, evaluated each of the areas of concern and compared current part 708 regulations with the pilot program. We will update the status of this recommendation after we review the resulting report.
    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 expedite the department's time frames for codifying in regulatory language its policy that retaliation for nuclear safety-related disclosures is a nuclear safety violation and develop a specific schedule for issuing the proposed and final rules.

    Agency: Department of Energy
    Status: Open

    Comments: DOE concurred with the recommendation and planned to amend its regulations to clarify which DOE regulations constitute DOE Nuclear Safety Requirements. DOD planned to expedite the schedule for this rulemaking. We will update the status of this recommendation after we confirm DOE's actions
    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 direct DOE's Office of Enforcement to routinely collect information from the Department of Labor and other sources regarding substantiated cases of retaliation and take appropriate enforcement action.

    Agency: Department of Energy
    Status: Open

    Comments: According to DOE, the Office of Enforcement has revised its internal implementing procedure to require that a review of DOE Office of Hearings and Appeals whistleblower cases, Department of Labor complaints submitted under the Energy Reorganization Act, and an online legal research service (for court decisions) be conducted each quarter to identify cases wherein a DOE contractor may have retaliated against an employee for reporting a safety concern and evaluate the information for potential enforcement action. We will update the status of this recommendation after we review the updated procedure.
    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. DOE officials said that the department was revising the Integrated Safety Management policy but the revisions are currently on hold indefinitely along with all other actions to publish new, or update existing departmental directives in response to two Presidential Executive Orders issued in January and February 2017 that directed federal agencies to, among other things, reduce and reform agency regulations.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    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: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it plans to identify opportunities for setting measurable goals related to regulatory science. The agency indicated that it would provide an update by 3/6/17.
    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: On 9/6/16, FDA provided an update on its actions to address this recommendation. FDA concurred with the recommendation and reiterated that it is identifying mechanisms to improve its tracking of funding across the priority areas. The agency indicated that it would provide an update by 3/6/17.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    28 open recommendations
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Administrator of the Food Safety and Inspection Service to develop agency policies that contain these requirements.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016 USDA reported that its science and safety councils chartered a joint biorisk management policy committee to oversee the revisions of existing policies to include department-wide incident reporting requirements and time frames. USDA also reported that FSIS will collaborate with the department to ensure that FSIS policies comply with USDA reporting requirements. USDA did not provide an anticipated completion date for revising departmental polices.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should review and update outdated department policies for managing hazardous biological agents in high-containment laboratories and direct the Administrators of the Animal and Plant Health Inspection Service (APHIS) and Agricultural Research Service to update their policies and, in the case of APHIS, establish a regular review schedule.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the science and safety councils' joint biorisk management policy committee will review and update the existing outdated USDA policies. In addition, USDA reported that APHIS will review agency policies for biological laboratories every 3-5 years or sooner, if necessary, and that this schedule will be reflected in USDA policy. USDA did not provide an anticipated completion date for reviewing and updating departmental polices. USDA reported that ARS has finalized its policies for its institutional biological safety committee in April 2016. Once all USDA and component agency policies have been updated and review schedules established, we will close this recommendation.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should routinely analyze results of the department's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to collect and analyze laboratory inspection and incident reports and share these reports and critical analyses with USDA senior leadership. USDA did not provide an anticipated start date for analyzing reports and sharing analyses with senior departmental officials. USDA stated that the joint biorisk committee also serves as an information-sharing platform across USDA agencies and, as such, is positioned to share lessons learned from analyses of inspection and incident reports with laboratory personnel as necessary. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing inspection and incident report analyses.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to revise existing departmental regulations to include requirements for routine reporting of inspection results to senior USDA officials. USDA did not provide an anticipated completion date for revising existing departmental regulations. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing reporting of inspection results or revisions of agency policies to require such reporting.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Agriculture should require routine reporting of incidents at agency laboratories to senior department officials.

    Agency: Department of Agriculture
    Status: Open

    Comments: In October 2016, USDA reported that the joint biorisk management policy committee will oversee efforts to revise existing departmental regulations to include requirements for routine reporting of laboratory incidents to senior USDA officials. USDA did not provide an anticipated completion date for revising existing departmental regulations. USDA also provided additional information on APHIS, ARS, and FSIS planned or ongoing incident reporting or revisions of agency policies to require such reporting.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control for all of DOD's high-containment laboratories, not just for its select agent-registered laboratories, or direct the Secretaries of the Air Force, Army, and Navy to revise their existing, respective policies to contain these requirements.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should direct the Secretaries of the Air Force and Army to review and update their respective outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should routinely analyze agencies' inspection results and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel, or direct the Secretaries of the Army and Navy to do so.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should require routine reporting of the results of Air Force, Army, and Navy inspections of non-select agent registered laboratories to senior department officials.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should require routine reporting of laboratory incidents at Air Force, Army, and Navy non-select agent registered laboratories to senior department officials.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should direct the Secretaries of the Army and Navy to require reporting of agency and select agent laboratory inspection results to senior agency officials.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Defense should develop time frames for the 19 specific recommendations from the July 2015 review, or direct the Secretary of the Army to do so.

    Agency: Department of Defense
    Status: Open

    Comments: In June 2016, DOD noted that its comments on the final report--in which it agreed with all of our findings and recommendations for the department--had not changed. However, DOD did not provide us with an update on its status in implementing these recommendations.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Energy should revise existing department policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inspections, or direct the Administrator of the National Nuclear Security Administration and the Director of the Office of Science to develop agency policies that contain this requirement.

    Agency: Department of Energy
    Status: Open

    Comments: In August 2016, DOE reported that it is revising department policy for its select agent and toxin work to highlight oversight of facilities working with these agents and toxins. DOE will solicit input from NNSA, the Office of Science, and its biosurety executive team to determine if specific inspection requirements should be included in the select agent, or other department or agency policies. DOE provided us with information as to other department policies and regulations that allow for inspections. DOE plans to complete its efforts by the end of July 2017. We maintain that DOE should make laboratory inspection requirements explicit and that these requirements apply to all high-containment laboratories, not just those registered with the select agent program.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Energy should review and update its outdated policies for managing hazardous biological agents in high-containment laboratories.

    Agency: Department of Energy
    Status: Open

    Comments: In August 2016, DOE reported that it is updating its outdated select agent policy and plans to complete this update by the end of July 2017.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of the Environmental Protection Agency (EPA) should revise existing EPA policies for managing hazardous biological agents in high-containment laboratories to contain specific requirements for inventory control, or direct the Director of the Office of Pesticide Programs to incorporate this requirement into its policy.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA agreed with this recommendation in its February 2016 comments on the draft report, but maintains that agency, or senior-level policies, exist that include this requirement. EPA officials cited a Microbiology Laboratory Branch standard operating procedure (SOP) as containing inventory control requirements for the agency's one high-containment laboratory. However, in July 2016, EPA officials told us that it disagreed with our assessment that the SOP, as a laboratory-level document, was insufficient to meet our expectations for senior-level policies. In November 2016, EPA officials reiterated its position stating that the SOP had been approved by senior agency management and, as the requirements in it are universally applied by all laboratory staff, appropriately represents an agency-level policy. EPA further noted that the Office of Pesticide Policy, in which the Microbiology Laboratory Branch is located, is a sub-office within EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), an Assistant Administrator-level office. We continue to believe that senior-level policies--in this case, either those policies issued at the EPA level or at the OCSPP/OPP level--that include all of the policy elements we analyzed reflect critical management commitment to and support for a culture of laboratory safety throughout the organization, regardless of the number of agency laboratories.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of EPA should review and update EPA's outdated policies for managing hazardous biological agents in high-containment laboratories and establish a regular schedule for reviewing and updating EPA and Office of Pesticide Programs policies.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In July 2016, EPA reported that the policies and procedures for both the facility that houses its microbiology laboratory and the laboratory itself are reviewed and updated on a bi-yearly or yearly basis consistent with the EPA schedules for biosafety and laboratory plans set in policy. However, EPA did not provide us with the policy that sets the EPA schedules. In addition, our analysis focused on policy documents issued by EPA or its senior-level offices, such as EPA's Safety, Health, and Environmental Management Program manual, dated November 2012. When we analyzed that policy for the report, we were unable to determine whether it was up-to-date because it did not include a review and update schedule or a specific recertification date. As of November, 2016, EPA maintains that this recommendation has been completed, because the office revised the standard operating procedure that provides guidance for establishing the receipt, expiration dates, and disposal of biological inventory used in the laboratory. As of April 2017, we have reached out to EPA for documentation of the actions the agency stated it has taken. Until received, we continue to believe that EPA action on this recommendation is still needed, such as by providing an updated EPA-level safety manual that includes a schedule for reviewing and updating, or providing EPA's schedule set in policy, so long as it also applies to agency- or senior office-level policies.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Administrator of EPA should require routine reporting of the results of department, agency, and select agent laboratory inspections to senior department officials.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA agreed with this recommendation in its February 2016 comments on the draft report. ?In July 2016, EPA reported that its high-containment laboratory will notify senior officials within 3 weeks of any laboratory inspection findings. ?This is a positive step. We are waiting for EPA to provide us with supporting documentation.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials, including the types of incidents that should be reported, to whom, and when, or direct the Director of CDC and the Commissioner of FDA to incorporate these requirements into their respective policies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2016, HHS reported that both CDC and FDA were working to incorporate incident reporting requirements and time frames into formal agency policies and practices but did not provide an anticipated completion date. In summer 2017, CDC and FDA reported that they were continuing to incorporate incident reporting, which includes all laboratory incidents, accidents, injuries, infections, and near-misses, into formal agency policies. CDC did not provide an anticipated completion date. FDA anticipated completing the policy revisions/updates by summer 2018.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for training and inspections for all high-containment component agency laboratories and not just for their select-agent-registered laboratories; or direct the Director of CDC to provide these requirements in agency policies.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2016, HHS reported that CDC plans to revise its policies to include training and inspection requirements for inspections for all high-containment laboratories but did not provide an anticipated completion date. In June 2017, HHS reported that CDC was in the process of revising its formal policies to ensure they included requirements for training and inspections for all of the agency's high-containment laboratories but did not provide an anticipated completion date.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should require routine reporting of the results of agency and select agent laboratory inspections to senior department officials.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2016, HHS reported that CDC was working with FDA and NIH to establish a process for notifying HHS leadership of inspection results through the department's Biosafety and Biosecurity Coordinating Council. HHS did not provide us with an anticipated time frame for implementing this notification practice or when the agencies plan to begin notifying HHS of inspection results.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should direct the Director of NIH and the Commissioner of FDA to require routine reporting of the results of agency laboratory inspections--and in the case of FDA, require routine reporting of select agent inspection results--to senior agency officials.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2016, HHS reported that FDA is working to establish a process for notifying senior agency officials of inspection results, and in August 2017, FDA reported that it was in the process of updating its policies to reflect such a notification process. FDA anticipated that the updated policies and processes would be in place by summer 2018. In August 2016, HHS reported that NIH's ongoing practice is to report the results of external inspections to senior agency officials and, in May 2016, developed a standard operating procedure that outlines this reporting process. In March 2017, NIH officials provided assurance that its Division of Occupational Safety and Health provides NIH's intramural governing body with information about NIH's safety performance at least annually; officials further assured that this information includes the overall results of annual inspections (or audits, as NIH calls them) of all NIH laboratories and discussion of the top 10 most report safety infractions for the year. GAO considers NIH to have implemented the recommended action. GAO will close the overall recommendation once FDA has taken equivalent, appropriate action.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Health and Human Services should require routine reporting of incidents at CDC, FDA, and NIH laboratories to senior department officials.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In August 2016, HHS reported that its Biosafety and Biosecurity Council is working to establish incident reporting requirements for CDC, FDA, and NIH but did not provide an anticipated completion date. HHS noted that NIH formally adopted a standard operating procedure that lays out the agency's requirements for reporting incidents to senior officials.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should develop department policies, or direct the Directors of Fish and Wildlife Service and U.S. Geological Survey to develop agency policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials--including the types of incidents that should be reported, to whom, and when--and specific requirements for roles and responsibilities, training, inventory control, and inspections.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that the Fish and Wildlife Service and U.S. Geological Survey will develop agency-level policies that contain the key elements GAO identified. DOI did not provide us with a time frame for these activities.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should routinely analyze the results of the agency's laboratory inspections and incident reports to identify potential trends that may highlight recurring laboratory safety or security issues and share lessons learned with laboratory personnel, or direct the Directors of Fish and Wildlife Service and U.S. Geological Survey to do so.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that its Biosafety Working Group, composed of officials across the department, including Fish and Wildlife Service and U. S. Geological Survey, is developing an automated process for analyzing results of laboratory inspections and incident reports to identify safety and security trends. The working group is also developing a process to share information gleaned from these analyses, including lessons learned, with laboratory personnel in a timely manner. DOI did not provide us with a time frame for these activities.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should require routine reporting of the results of agency and select agent inspections to senior department officials.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that in according with the reporting requirements it plans to incorporate into agency-level policies in response to our first recommendation, Fish and Wildlife Service and U. S. Geological survey will be required to submit routine or periodic reports of the results of agency and select agent inspections to the department's designated agency safety and health official.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of the Interior should direct the Director of the U.S. Geological Survey to require routine reporting of the results of agency and select agent laboratory inspections to senior agency officials.

    Agency: Department of the Interior
    Status: Open

    Comments: In July 2016, DOI reported that the U. S. Geological Survey will modify and expand its existing policies to require reporting of agency and select agent inspection results to senior USGS officials.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Veterans Affairs should develop department policies for managing hazardous biological agents in high-containment laboratories that contain specific requirements for reporting laboratory incidents to senior department officials--including the types of incidents that should be reported, to whom, and when--and requirements for inventory control for all of its high-containment laboratories, including its select agent-registered clinical laboratory, or direct the Under Secretary of Health to incorporate these requirements into its policies.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: In June 2016, VA reported that while it has policies for reporting laboratory incidents at the local level (VA medical center or laboratory level), VA plans to develop a national level policy for reporting laboratory incidents to senior department officials, including the types of incidents to report, to whom, and when. VA will convene a task force for the purposes of developing such a policy and anticipates that the task force will finalize its policy by March 2018. In June 2017, VA reported that the task force concluded that VA's existing emergency management plan contained all of the necessary requirements for laboratory incident reporting. However, VA has not provided GAO with the emergency management plan. VA further noted that a intradepartmental memorandum was sufficient for making employees aware of such policy requirements in the emergency plan and that such a memorandum was drafted and was being processed for dissemination throughout VA, with an anticipated completion date of August 2017.
    Recommendation: To ensure that federal departments and agencies have comprehensive and up-to-date policies and stronger oversight mechanisms in place for managing hazardous biological agents in high-containment laboratories and are fully addressing weaknesses identified after laboratory safety lapses, the Secretary of Veterans Affairs should direct the Under Secretary of Health to review and update outdated agency policies for managing hazardous biological agents in high-containment laboratories.

    Agency: Department of Veterans Affairs
    Status: Open

    Comments: VA updated and finalized its outdated policy for its clinical laboratories in February 2016. In July 2016, VA reported that it has begun updating its policies for its research laboratories and anticipated finalizing them in 6 months. In June 2017, VA reported that its policies for its research laboratories remain under review and revision, with an anticipated completion date of December 2017.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To improve USDA's ability to oversee GE crops, the Secretary of Agriculture should direct the Administrator of the Animal and Plant Health Inspection Service (APHIS) to develop a timeline, with milestones and interim steps, for updating its existing regulations to cover GE crops developed with alternative technologies that either do not use plant pests or use plant pests but do not result in plant pest deoxyribonucleic acid in the crop developed.

    Agency: Department of Agriculture
    Status: Open

    Comments: In its August 2016 Statement of Action on our report, USDA notes that it has a timeline, but the department did not provide documentation of this timeline. The Statement of Action also indicates that USDA planned to update its biotechnology regulations and publish a proposed rule in the summer of 2016. As of December 2016, the proposed rule had not yet been published.
    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 is no indication whether stakeholders internal to the department have 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.
    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.
    Director: Linda Kohn
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To enhance its stewardship of clinical trials across the ICs, the Secretary of the Department of Health and Human Services (HHS) should direct the NIH OD to finalize data on clinical trial activity that the OD needs to collect from ICs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation and stated that the agency plans to complete its efforts to identify additional data that will be collected from the ICs on a regular basis. HHS indicated that these data will provide the OD with readily available information on the number, type, and progress of clinical trials funded across the ICs. HHS stated that a working group of NIH staff with expertise in clinical trials has been assembled to begin developing specific requirements for the enterprise-wide system for clinical trial management and oversight.
    Recommendation: To enhance its stewardship of clinical trials across the ICs, the Secretary of HHS should direct the NIH OD to establish and implement a process for using those data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation and stated that the agency plans to complete its efforts to identify additional data that will be collected from the ICs on a regular basis. HHS indicated that these data will provide the OD with readily available information on the number, type, and progress of clinical trials funded across the ICs. HHS stated that a working group of NIH staff with expertise in clinical trials has been assembled to begin developing specific requirements for the enterprise-wide system for clinical trial management and oversight, and that the system will be used by NIH OD and the NIH ICs to meet stewardship responsibilities and for strategic planning and priority setting.
    Director: Fleming, Susan A
    Phone: (202) 512-2834

    1 open recommendations
    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: When we confirm what actions Congress has taken in response to this matter for consideration, we will provide updated information.
    Director: Rebecca Gambler
    Phone: (202) 512-8777

    9 open recommendations
    Recommendation: To better ensure that DHS complies with TVPRA requirements for training, screening, and transferring UAC to HHS, the Secretary of Homeland Security should direct the Commissioner of U.S. Customs and Border Protection to develop and implement TVPRA training for OFO officers at airports who have substantive contact with UAC.

    Agency: Department of Homeland Security
    Status: Open

    Comments: The Office of Field Operations (OFO) within U.S. Customs and Border Protection (CBP), in collaboration with U.S. Immigration and Customs Enforcement, conducted a "Train-the-Trainer" conference in August 2015 that focused on juvenile and unaccompanied alien children (UAC). The conference, among other things, addressed screening requirements for UAC consistent with Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). CBP officers who received this additional training were then responsible for training other officers who process UAC at the ports of entry. According to CBP, while the conference was comprehensive, it did not fully encompass CBP's needs. In June 2016, CBP reported that OFO, Office of Chief Counsel, and a headquarters-level working group on UAC issues are finalizing a revised Form CBP-93 and with that are developing a detailed, relevant Train-the-Trainer course for officers responsible for TVPRA at all CBP ports of entry. In December 2016, CBP notified GAO that OFO, in coordination with CBP's Office of Training and Development, was concluding the design and embarking on the development phase of a distance learning course, tentatively entitled "Processing, Holding, and Transfer of Unaccompanied Alien Children by CBP." This course will be an annual requirement for all OFO officers. In April 2017, CBP reported that OFO was no longer pursuing a separate Train-the-Trainer course for CBP officers at air ports of entry. However, CBP continues to develop a new UAC training course. The new course is a collaborative effort between OFO and USBP, in consultation with CBP's Office of Chief Counsel, and in partnership with CBP's Office of Training and Development (OTD) to develop, deconflict, and revise training consistent with requirements under TVPRA, specifically outlining rules to identify and screen UAC, among other things. As of September 2017, CBP estimates that they will finalize the training module by June 2018. To fully address this recommendation, CBP needs to ensure that OFO officers at airports who have substantive contact with UAC complete this training.
    Recommendation: To better ensure that DHS complies with TVPRA requirements for training, screening, and transferring UAC to HHS, the Secretary of Homeland Security should direct the Commissioner of U.S. Customs and Border Protection to revise the Form 93 to include indicators or questions that agents and officers should ask UAC to better assess (1) a child's ability to make an independent decision to withdraw his or her application for admission to the United States and (2) credible evidence of the child's risk of being trafficked if returned to his or her country of nationality or last habitual residence.

    Agency: Department of Homeland Security
    Status: Open

    Comments: In September 2015, CBP officials stated that CBP formed a working group in headquarters with representatives from the department's Office of Policy and Office for Civil Rights and Civil Liberties to examine the screening process for UAC. In addition, CBP officials noted that CBP is in the process of convening a similar group in the field. According to CBP officials, the working group meets weekly and is coordinating with nongovernmental organizations and the United Nations High Commissioner for Refugees, among others. As of June 30, 2016, CBP reported that CBP's Office of Field Operations (OFO) and U.S. Border Patrol (BP) have finalized and routed the Form CBP-93 to the OFO Executive Assistant Commissioner and United States Border Patrol Chief for final approval. As of June 2017, the revised CBP Form 93 is still under review and CBP officials estimate that the review process will be completed by December 31, 2017. To fully address this recommendation, CBP should revise the Form 93 to include indicators or questions that CBP officers and Border Patrol agents should ask UAC relative to their ability to make an independent decision and regarding the potential risk of the UAC being trafficked if returned to their country of nationality or last habitual residence.
    Recommendation: To better ensure that DHS complies with TVPRA requirements for training, screening, and transferring UAC to HHS, the Secretary of Homeland Security should direct the Commissioner of U.S. Customs and Border Protection to provide guidance to Border Patrol agents and OFO officers that clarifies how they are to implement the TVPRA requirement to transfer to HHS all Mexican UAC who have fear of returning to Mexico owing to a credible fear of persecution.

    Agency: Department of Homeland Security
    Status: Open

    Comments: In commenting on a draft of our report, DHS indicated that CBP's U.S. Border Patrol (USBP) and Office of Field Operations (OFO) would issue further guidance to agents and officers emphasizing TVPRA transfer procedures for UAC who are nationals or habitual residents of Canada or Mexico and who are victims of a severe form of trafficking in persons. In September 2015, CBP reported that USBP and OFO estimated implementing this additional guidance by the end of calendar year 2015. In January 2016, CBP reported to GAO that, since June 2015, a headquarters level working group had been reviewing CBP's screening process for UAC. According to CBP officials, the activities of this working group will influence the guidance that will be deployed to Border Patrol agents and OFO officers and that USBP and OFO will be working together to develop additional guidance to the field by September 2016. In December 2016, CBP notified GAO that Border Patrol and OFO have partnered with CBP's Office of Training and Development, as well as the Office of Chief Counsel, to develop a distance learning course, tentatively entitled "Processing, Holding, and Transfer of Unaccompanied Alien Children by CBP." According to CBP, this course will be an annual requirement for all CBP agents and officers. As of September 2017, CBP estimates that they will finalize the training module by June 2018. To fully address this recommendation, CBP should ensure that this distance learning training module on how to implement the Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA) criteria is developed and implemented, as required by CBP policy, to all Border Patrol agents and OFO officers.
    Recommendation: To better ensure that DHS complies with TVPRA requirements for training, screening, and transferring UAC to HHS, the Secretary of Homeland Security should direct the Commissioner of U.S. Customs and Border Protection to develop and implement guidance on how Border Patrol agents and OFO officers are to implement the TVPRA requirement to transfer to HHS all Canadian and Mexican UAC who are victims of a severe form of trafficking in persons.

    Agency: Department of Homeland Security
    Status: Open

    Comments: In commenting on a draft of our report, DHS indicated that CBP's U.S. Border Patrol (USBP) and Office of Field Operations (OFO) would issue further guidance to agents and officers emphasizing TVPRA transfer procedures for UAC who are nationals or habitual residents of Canada or Mexico and who are victims of a severe form of trafficking in persons. In September 2015, CBP reported that USBP and OFO estimated implementing this additional guidance by the end of calendar year 2015. In January 2016, CBP reported to GAO that, since June 2015, a headquarters level working group has been reviewing CBP's screening process for UAC. According to CBP officials, the activities of this working group will influence the guidance that will be deployed to Border Patrol agents and OFO officers and that USBP and OFO will be working together to develop additional guidance to the field by September 2016. In December 2016, CBP notified GAO that Border Patrol and OFO have partnered with CBP's Office of Training and Development as well as the Office of Chief Counsel to develop a distance learning course, tentatively entitled "Processing, Holding, and Transfer of Unaccompanied Alien Children by CBP." According to CBP, this course will be an annual requirement for all CBP agents and officers. As of September 2017, CBP estimates that they will finalize the training module by June 2018. To fully address this recommendation, CBP should ensure that this distance learning training module on how to implement the Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA) criteria is developed and implemented, as required by CBP policy, to all Border Patrol agents and OFO officers.
    Recommendation: To better ensure that DHS complies with TVPRA requirements for training, screening, and transferring UAC to HHS, the Secretary of Homeland Security should direct the Commissioner of U.S. Customs and Border Protection to ensure that Border Patrol agents document the basis for their decisions when assessing screening criteria related to (1) an unaccompanied alien child's ability to make an independent decision to withdraw his or her application for admission to the United States, and (2) whether UAC are victims of a severe form of trafficking in persons.

    Agency: Department of Homeland Security
    Status: Open

    Comments: As of December 2015, CBP officials reported that an internal working group charged with assessing UAC screening procedures was considering issues related to independent decision-making and appropriate documentation as it develops a revised screening tool. As of June 30, 2016, CBP reported that CBP's Office of Field Operations (OFO) and U.S. Border Patrol (BP) had finalized and routed a revised CBP Form 93 to the OFO Executive Assistant Commissioner and United States Border Patrol Chief for final approval. As of August 31, 2016, the revised CBP Form 93 was still under review and CBP officials estimated that the review process would be completed by December 31, 2016. In January 2017, CBP notified GAO that the expected completion date for the revised form is April 2017, and that direction to Border Patrol agents on the new form would be delivered by June 2017. In June 2017, CBP told GAO that Border Patrol and other CBP partners were continuing to determine which changes are necessary to the CBP Form 93 and estimated that these efforts would not be completed until December 31, 2017. As of September 2017, CBP reported that these efforts would not be completed until June 2018. To fully address this recommendation, CBP should ensure that Border Patrol agents document the basis for their decisions when assessing screening criteria related to (1) an unaccompanied alien child's ability to make an independent decision to withdraw his or her application for admission to the United States, and (2) whether UAC are victims of a severe form of trafficking in persons.
    Recommendation: To better ensure that DHS complies with TVPRA requirements for training, screening, and transferring UAC to HHS, the Secretary of Homeland Security should direct the Commissioner of U.S. Customs and Border Protection to determine which agents and officers who have substantive contact with UAC, complete the annual UAC training, and ensure that they do so, as required.

    Agency: Department of Homeland Security
    Status: Open

    Comments: On July 1, 2015, the Assistant Commissioner for Field Operations (OFO) disseminated a memorandum to all OFO Field Office Directors regarding the mandatory annual UAC training requirement. The Assistant Commissioner directed all Field Offices to ensure that officers completed the required training by December 31, 2015 (the memo also specified which officers are required to complete the training). On July 31, 2015, the Chief of the U.S. Border Patrol disseminated a memorandum to all Chief Patrol Agents and Directorate Chiefs for dissemination to all uniformed personnel, including supervisors, regarding the mandatory annual UAC training requirement. CBP documentation indicates that CBP implemented a new learning management system mandated by DHS on July 13, 2015, through which online training courses are offered to all CBP employees. Further, in 2016 DHS added a feature to this system that provided the capability to produce reports on courses completed by CBP employees. In April 2017, CBP provided 2016 data on the OFO officers and Border Patrol agents that had completed the required UAC training course. According to the data, 23 percent of OFO officers and 7 percent of Border Patrol agents required to complete the training had not done so. CBP officials stated that they plan to take steps to increase the percent of agents and officers who complete the required training in 2017 and will provide new data to GAO in early 2018. To fully address this recommendation, Border Patrol and OFO should ensure that all required personnel have completed the annual training, as required.
    Recommendation: To help ensure that DHS has complete and reliable data needed to ensure compliance with the UAC time-in-custody requirement under TVPRA and for required reports on UAC time in custody under the Flores Agreement, the Secretary of Homeland Security should require ICE officers to record accurate and reliable data in their automated system when UAC leave ICE custody in order to track the length of time UAC are in ICE custody.

    Agency: Department of Homeland Security
    Status: Open

    Comments: In a July 23, 2015 memo, ICE's Assistant Director for Custody Management, with concurrence from the Acting Assistant Director for Field Operations, provided instructions to all ICE Field Office Directors, Deputy Field Office Directors, and Field Office Juvenile Coordinators (FOJCs) with instructions for processing juveniles, including unaccompanied alien children (UAC). The memo stated that FOJCs or assigned officers must immediately book UAC into ICE's automated system upon the UAC's transfer into ICE's custody (including ICE transportation contractors). The instructions state that no more than 4 hours may elapse without recording the UAC's time in ICE custody. Further, the instructions stated that when ICE transfers UAC to a new location, that FOJCs, or other assigned officers, must also ensure that ICE's automated system is updated to reflect the exact location of the transfer. According to ICE, these instructions are to be included in a juvenile processing handbook that will provide detailed instructions for officers in processing and managing juvenile cases. ICE expects to complete this handbook by June 30, 2016. As of October 2016, the handbook was still being cleared within ICE. To fully implement our recommendation, ICE should require that officers record accurate and reliable data (date and time) in their automated system when UAC leave ICE custody.
    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

    Comments: In September 2015, DHS stated that the department was collaborating with HHS on finalizing a Memorandum of Agreement (MOA) regarding UAC procedures. According to DHS, the MOA is meant to provide a framework for interagency coordination on the responsibilities of the parties in coordinating and establishing procedures, shared goals, and interagency cooperation with respect to UAC. In February 2016, DHS and HHS finalized the MOA. The MOA states that DHS and HHS agree to establish a Joint Concept of Operations (JCO) that should be completed no later than one year following the signing of the MOA. According to the MOA, the JCO should include, among other things, standard protocols for consistent interagency cooperation on the care, processing, and transport of UAC during both steady state operations, as well as in the event the number of UAC exceeds the standard capabilities of the departments to process, transport, and/or shelter with existing resources. As of February 2017, HHS told GAO that HHS and DHS are still in the process of drafting the JCO. To fully address the recommendation, DHS and HHS will need to ensure that the JCO, once finalized and implemented, includes 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.
    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

    Comments: In September 2015, DHS stated that the department was collaborating with HHS on finalizing a Memorandum of Agreement (MOA) regarding UAC procedures. According to DHS, the MOA is meant to provide a framework for interagency coordination on the responsibilities of the parties in coordinating and establishing procedures, shared goals, and interagency cooperation with respect to UAC. In February 2016, DHS and HHS finalized the MOA. The MOA states that DHS and HHS agree to establish a Joint Concept of Operations (JCO) that should be completed no later than one year following the signing of the MOA. According to the MOA, the JCO should include, among other things, standard protocols for consistent interagency cooperation on the care, processing, and transport of UAC during both steady state operations, as well as in the event the number of UAC exceeds the standard capabilities of the departments to process, transport, and/or shelter with existing resources. As of August 2017, HHS told GAO that HHS and DHS are still in the process of drafting the JCO. To fully address the recommendation, DHS and HHS will need to ensure that the JCO, once finalized and implemented, includes 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.
    Director: Alicia Puente Cackley
    Phone: (202) 512-8678

    2 open recommendations
    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. There has been 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. As of March 1, 2017, the bill has not been reintroduced in the 115th Congress.
    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. There has been no legislative action identified. No legislation was introduced as of March 1, 2017, 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.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To help ensure that FSIS efforts protect human health by reducing Salmonella and Campylobacter contamination in FSIS-regulated poultry products, in future revisions of the compliance guidelines on controlling Salmonella and Campylobacter, the Secretary of Agriculture should direct the Administrator of FSIS to ensure the inclusion of information on the effectiveness of each recommended farm practice to reduce these pathogens in live poultry.

    Agency: Department of Agriculture
    Status: Open

    Comments: In December 2015, USDA's Food Safety and Inspection Service released the draft revised compliance guideline to assist poultry establishments in controlling Salmonella and Campylobacter in raw poultry. The draft guideline included information on the effectiveness of each recommended farm practice to reduce Salmonella and Campylobacter in live poultry. FSIS announced the availability of and requested comment on the revised compliance guideline in a December 2015 Federal Register Notice. FSIS officials told us that they anticipate finalizing the draft guideline in fiscal year 2017 and the guideline states that while the document is draft, establishments are encouraged to incorporate information in the guideline in their decision-making process. As of April 2017, FSIS had not finalized the guideline.
    Director: Susan Fleming
    Phone: (202) 512-2834

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To address the increased risk posed by new gathering pipeline construction in shale development areas, the Secretary of Transportation, in conjunction with the Administrator of the Pipeline and Hazardous Materials Safety Administration, should move forward with a Notice of Proposed Rulemaking to address gathering pipeline safety that addresses the risks of larger-diameter, higher-pressure gathering pipelines, including subjecting such pipelines to emergency response planning requirements that currently do not apply.

    Agency: Department of Transportation
    Status: Open
    Priority recommendation

    Comments: PHMSA has drafted proposed regulations for both gas and hazardous liquid gathering pipelines. Specifically, PHMSA published Notices of Proposed Rulemaking to separately address safety issues associated with hazardous liquid gathering pipelines in October 2015 and gas gathering pipelines in April 2016. These proposed regulations partly address our recommendation by proposing new rules to address risks posed by new gathering pipeline construction, but do not fully address our recommendation to subject these pipelines to emergency response planning requirements, particularly for hazardous liquid pipelines. As of October 2016, PHMSA has determined that it needs one year's worth of data before it can begin assessing what regulations are needed to fully address the risks of hazardous liquid pipelines.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To ensure that EPA's oversight of the class II program is effective at protecting drinking water sources from the underground injection of large amounts of wastewater that will be produced with increasing domestic oil and gas production, and to support nationwide reporting goals until the national UIC database is complete, the Administrator of the Environmental Protection Agency should (1) improve the 7520 data for reporting purposes, as well as to help with quality assurance for the national UIC database, by developing and implementing a protocol for states and regions to enter data consistently and for regions to check 7520 data for consistency and completeness to ensure that data collected from state and EPA-managed class II programs are complete and comparable for purposes of reporting at a national level, and (2) in the interim, develop a method to use the 7520 database to report UIC data, including data on class II wells, until the national UIC database is fully populated with state data.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In November 2016, EPA said that its 7520 database is current as of 2014 and the quality assurance process has been completed. It is developing a method to use the database to report aggregated national data on the Underground Injection Control (UIC) program.
    Recommendation: To ensure that EPA's oversight of the class II program is effective at protecting drinking water sources from the underground injection of large amounts of wastewater that will be produced with increasing domestic oil and gas production, and to ensure that EPA maintains enforcement authority of state program requirements, the Administrator of the Environmental Protection Agency should (1) conduct a rulemaking to incorporate state program requirements, and changes to state program requirements, into federal regulations, and (2) at the same time, evaluate and consider alternative processes to more efficiently incorporate future changes to state program requirements into federal regulations without a rulemaking.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: EPA agrees with GAO's analysis that state program requirements and changes should be approved and codified in federal regulations. However, EPA does not agree with GAO's recommendation to conduct one comprehensive rulemaking to achieve this. In November 2016, EPA officials said they will continue to explore alternative methods for maintaining federal enforceability under the current statutory provisions; it plans to finish its efforts in January 2017. GAO will continue to monitor this recommendation.
    Recommendation: To ensure that EPA's oversight of the class II program is effective at protecting drinking water sources from the underground injection of large amounts of wastewater that will be produced with increasing domestic oil and gas production, the Administrator of the Environmental Protection Agency should evaluate and revise, as needed, UIC program guidance on effective oversight to identify essential activities that EPA headquarters and regions need to conduct to effectively oversee state and EPA managed programs.

    Agency: Environmental Protection Agency
    Status: Open

    Comments: In November 2016, EPA stated that it has developed a national framework for oversight of the UIC program and to transfer knowledge to new staff. EPA said that it will continue to evaluate whether to update its guidance. We are continuing to monitor EPA's progress on this recommendation.
    Director: Brown Barnes, Cindy S
    Phone: (202) 512-9345

    4 open recommendations
    including 1 priority recommendation
    Recommendation: The Secretary of Labor should direct the Assistant Secretary for Occupational Safety and Health to take steps to identify high risk facilities working with ammonium nitrate and develop options to target them for inspection.

    Agency: Department of Labor
    Status: Open
    Priority recommendation

    Comments: In 2016, OSHA officials reported that implementation of their planned local emphasis programs focused on safe use and storage of ammonium nitrate and anhydrous ammonia at fertilizer facilities was delayed due to litigation regarding process safety management enforcement in the fertilizer industry. As of July 2017, OSHA officials stated that with the recent conclusion of that litigation, OSHA is considering initiation of local emphasis programs focused on the storage and handling of ammonium nitrate and anhydrous ammonia at fertilizer facilities. Once initiated, a local emphasis program requires a focused inspection program with facilities chosen at random from the list of facilities in appropriate industry codes. 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. We will close this recommendation when the local emphasis programs are initiated.
    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. Currently, 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 requests for information.
    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. In a June 2016 update from EPA, EPA stated that OSHA is considering whether ammonium nitrate should be added to the list of chemicals subject to OSHA Process Safety Management regulations. According to the June 2016 update, EPA stated that while the agency is not presently proposing that ammonium nitrate be added to the list of substances subject to the RMP rule, the agency may elect to propose such a listing at a later date.
    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. The RFI 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, this 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 request for information.
    Director: Gomez, Jose A
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    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 August 2017, EPA's Integrated Risk Information System (IRIS) Program officials stated that IRIS assessments that support policy and regulatory decisions for EPA's programs and regions, and state agencies, are being consolidated into a new portfolio to optimize the application of best available science and technology. According to IRIS Program officials, the new portfolio is being shaped for use by many EPA program and regional offices, states, and other federal agencies. IRIS Program officials told us that they expect these changes to significantly increase the number of completed assessments. GAO will update this recommendation after receiving documentation that elaborates on the new portfolio, or other efforts, that strengthen coordination across EPA offices and with other federal research agencies to help identify and fill data gaps, and describe alternative sources of information, consistent with the intent of the original recommendation.
    Director: Trimble, David C
    Phone: (202) 512-3841

    3 open recommendations
    including 3 priority recommendations
    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, the Administrator of EPA should consider promulgating a rule under TSCA section 8, or take action under another section, as appropriate, to require chemical companies to report chemical toxicity and exposure-related data they have submitted to the European Chemicals Agency.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: As of July 2017, EPA is better positioned to take action to require chemical companies to report chemical toxicity and exposure-related data submitted to the European Chemicals Agency due to passage of the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Since the law was signed by the President on June 22, 2016, EPA finalized a rule to establish the agency's process for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health or the environment and finalized a rule to require industry reporting of chemicals manufactured or processed in the US over the past 10 years. However, EPA has not yet carried out actions consistent with the substance of our recommendation. Once EPA has carried out such actions, we will reassess the status of this open recommendation.
    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, the Administrator of EPA should consider promulgating a rule under TSCA section 8, or take action under another section, as appropriate, to require chemical companies to report exposure-related data from processors to EPA.

    Agency: Environmental Protection Agency
    Status: Open
    Priority recommendation

    Comments: As of July 2017, EPA is better positioned to take action to require chemical companies to report exposure-related data from processors to EPA due to passage of the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Since the law was signed by the President on June 22, 2016, EPA has completed some implementation activities, including finalizing a rule to require industry reporting of chemicals manufactured or processed in the US over the past 10 years. However, EPA has not yet carried out actions consistent with the substance of our open recommendation. Once EPA has carried out such actions, we will reassess the status of this open recommendation.
    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 July 2017, EPA is better positioned to take action to require chemical companies to report chemical toxicity and exposure data, analyze the data, take necessary actions, and identify the resources needed for evaluating and managing risk to ensure chemical safety due to passage of the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Since the new law was signed by the President on June 22, 2016, EPA finalized a rule to establish the agency's process for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health or the environment and finalized a rule to require industry reporting of chemicals manufactured or processed in the U.S. over the past 10 years. However, EPA has not yet carried out actions consistent with the substance of our recommendation, including actually obtaining the data necessary to make risk-informed regulatory decisions, and then making those decisions as appropriate. Once EPA has carried out such actions, we will reassess the status of this open recommendation.
    Director: Cackley, Alicia P
    Phone: (202) 512-8678

    2 open recommendations
    Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should establish and incorporate metrics to assess efforts to increase awareness and use of SaferProducts.gov.

    Agency: Consumer Product Safety Commission
    Status: Open

    Comments: The Commission states that it measures overall awareness of SaferProducts.gov in a manner similar to the manner in which it measures the awareness of CPSC.gov: by the number of visits to the website. The Commission states that website visits is a reasonable proxy measure of overall awareness that is cost-effective to collect. According to the Commission, in fiscal year 2014, SaferProducts.gov had 2.4 million visits and 863,000 visitors, where visits are the number of sessions the site was hit and visitors are the count of unique IP addresses who came to the site. The Commission had previously indicated that it planned to include three questions on SaferProducts.gov in a National Awareness Survey designed to determine overall awareness of CPSC on a national level. While the Commission administered the survey, it did not include questions related to SaferProducts.gov. As of March 2017, the Commission has not taken specific steps to measure the overall awareness of SaferProducts.gov.
    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 had begun making usability improvements to SaferProducts.gov by improving the search functionality and improving the user experience of submitting incident reports. The Commission planned to include a tagline to its website to increase users' understanding of the site's purpose--either "Report. Search. Protect." or "Report. Search. Be Empowered." by March 2017. However, as of April 2017, SaferProducts.gov does not include a tagline. The Commission also has not made any other website improvements in this regard, nor have staff undertaken user experience studies to assess users' understanding of the site.
    Director: Dillingham, Gerald L
    Phone: (202)512-2834

    3 open recommendations
    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 August 2017, GAO confirmed that FAA's collection of flight hour data during registration renewals or annual maintenance inspections is not feasible because it would require rulemaking and potentially have a significant economic and paperwork impact on the GA community. FAA noted that, although previously the GA Activity Survey was somewhat limited for collecting more extensive flight hour data, improvements to the survey regarding flight hour data collection have resulted in a low standard error of 1.1 percent, which means that the agency and industry can have confidence in the aggregate results regarding how GA is operated in the national airspace system. While there may have been methodological improvements to the survey, FAA's response indicates that it does not require the collection of GA flight hour data. GAO maintains that estimates from the survey still 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 general aviation community.
    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: GAO confirmed in August 2017 that FAA's General Aviation Joint Steering Committee has undertaken a data-driven approach to resolving and mitigating the risks associated with all General Aviation (GA) fatal accidents and is exploring different metrics for monitoring individual industry segments utilizing tools such as the GA Activity Survey but that credible metrics for each industry sub-sector are currently not feasible. However, our recommendation was for FAA to develop metrics for industry segments because we found a variety of differences in accident and fatality rates among industry segments and believe that focusing on segments with higher instances of both is a better use of FAA's limited resources.
    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: GAO confirmed in August 2017 that FAA has established performance metrics for the activities underlying the 5-year strategy and that the GA fatal accident rate remains its primary performance measure. FAA also reported that additional performance measures would be developed in association with the General Aviation Joint Steering Committee working groups. However, FAA has provided no documentation of its metrics for the associated activities underlying the 5-year strategy therefore this recommendation remains open.
    Director: Fleming, Susan A
    Phone: (202)512-4431

    1 open recommendations
    Recommendation: In order to encourage vehicle owners to comply with safety recalls, provide vehicle owners with specific information about whether their vehicle is involved in a recall, and identify factors that affect recall completion rates, among other things, the Secretary of Transportation should direct the Administrator of NHTSA to develop a plan to use the data it collects on recall campaigns to analyze particular patterns or trends that may characterize successful recalls and determine whether these represent best practices that could be used in other recall campaigns.

    Agency: Department of Transportation
    Status: Open

    Comments: When we confirm what actions NHTSA has taken in response to this recommendation will provide updated information.
    Director: Wise, David J
    Phone: (202)512-5731

    1 open recommendations
    Recommendation: To ensure that FTA targets its resources effectively as it increases its safety efforts and is able to track the results of these efforts, the Secretary of Transportation should direct the FTA Administrator to use leading practices as FTA develops its plans for fiscal year 2011 and in the future. In particular, the Administrator should create a set of clear and specific performance goals and measures that (1) are aligned with the department's strategic safety goals and identify the intended results of FTA's various safety efforts and (2) address important dimensions of program performance.

    Agency: Department of Transportation
    Status: Open

    Comments: The Moving Ahead for Progress in the 21st Century Act (MAP-21), enacted in 2012, gave the Federal Transit Administration (FTA) authority to establish and enforce a new comprehensive framework for overseeing the safety of public transportation in the U.S. FTA is developing a new National Public Transportation Safety Program, including new safety regulations and a National Safety Plan, to implement this authority. FTA has proposed a National Safety Plan that identifies a potential set of performance measures for FTA, but does not identify related goals or targets. FTA officials said that they would address our recommendation within the next 6-12 months by establishing, within an internal performance plan, a set of clear and specific performance goals and measures for FTA that align with the leading practices we identify. We will follow up in Spring 2017 to check on FTA's progress in implementing this recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    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 August 2017, FDA reported that it remains committed to strengthening its efforts and systematically monitoring and evaluating the overseas offices' contributions to the agency's mission and objectives. FDA also stated that it is making significant progress in several areas by enhancing strategic planning and analysis, refining the Office of International Program's (OIP) performance metrics, and designing a monitoring and evaluation plan. For example, FDA stated it has developed a framework with refined performance metrics to distinguish and assess the distinct contribution of OIP and its foreign offices towards program objectives and broader agency goals. FDA said that the performance metrics will track and monitor the quantity, quality, and timeliness of activity outputs and intermediate outcomes resulting from OIP's work. The measures have been standardized and defined, and will be further disaggregated to enable various levels of analyses, including distinguishing the unique efforts by foreign offices and product type. According to FDA, it plans to roll out its performance framework, related metrics, and monitoring and evaluation processes in fiscal year 2018. FDA said it anticipates that its performance measures, enhanced monitoring, and increased sharing of best practices across foreign offices and FDA headquarters will facilitate tracking of performance, allow greater accountability, and provide a foundation for continuous improvement. GAO will continue to monitor FDA's progress.
    Director: Mccool, Thomas J
    Phone: (202)512-8678

    1 open recommendations
    Recommendation: In developing legislation for a national reporting system for the biological laboratory community, Congress may wish to consider provisions for the agency it designates as responsible for the system to take into account the following in design and implementation: (1) including stakeholders in setting system goals; (2) assessing labs' organizational culture to guide design and implementation decisions; (3) making reporting voluntary, with open-reporting formats that allow workers to report events in their own words and that can be submitted by all workers in a variety of modes (Web or postal), with the option to report to either an internal or external entity; (4) incorporating strong reporter protections, data deidentification measures, and other incentives for reporting; (5) developing feedback mechanisms and an industry-level entity for disseminating safety data and safety recommendations across the lab community; and (6) ensuring ongoing monitoring and evaluation of the safety reporting system and safety culture.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action on this recommendation.
    Director: Shames, Lisa R
    Phone: (202) 512-2649

    2 open recommendations
    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: In September 2014, FDA indicated that guidance on potential conflicts of interest for experts participating on GRAS panels is a priority for the agency. In its Final Rule on Substances Generally Recognized as Safe (81 FR 54959), issued Aug. 17, 2016, FDA stated that it had decided to issue guidance regarding conflicts of interest and that it would announce the availability of a draft guidance document through a notice in the Federal Register. As of December 2016, FDA had not yet issued this draft guidance.
    Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to monitor the appropriateness of companies' GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations.

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

    Comments: On Aug. 17, 2016, FDA published a final rule on Substances Generally Recognized as Safe (GRAS) (81 FR 54959). This final rule includes a section titled "Guidance on Documenting Conclusions of GRAS Status," which states that FDA is "issuing a guidance" for companies on how to document their GRAS determinations. It is not clear from the rule the time frame for issuing this guidance, whether it will be issued in draft first for comment, and whether it will part of the guidance on conflicts of interest that FDA also plans to issue at a later date, as noted elsewhere in the rule. As of December 2016, FDA had not issued this guidance.
    Director: Stephenson, John B
    Phone: (202)512-6225

    1 open recommendations
    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 December 2016, we have not identified actions by the Congress to establish in law requirements such as those in EO 13025.
    Director: Dillingham, Gerald L
    Phone: (202)512-4803

    1 open recommendations
    Recommendation: To help FAA improve the data on and the safety of air cargo operations, the Secretary of Transportation should direct the FAA Administrator to gather comprehensive and accurate data on all part 135 cargo operations to gain a better understanding of air cargo accident rates and better target safety initiatives. This can be done by separating out cargo activity in FAA's annual survey of aircraft owners or by requiring all part 135 cargo carriers to report operational data as part 121 carriers currently do.

    Agency: Department of Transportation
    Status: Open

    Comments: In 2017, FAA reported that the agency has determined that a redesign of the General Aviation and Part 135 Activity Survey (GA Survey) is not required to address the recommendation, as originally considered. Beginning with the GA survey for year 2016--survey results are being processed--FAA will identify aircraft certified for cargo operations and use the certificate type to break out operational data for cargo operations. FAA also discussed this plan with stakeholders, including the Regional Air Cargo Carriers Association, and believe this new approach will meet the recommendation for gathering comprehensive and accurate data on all part 135 cargo operations. In June 2017, FAA informed us that the agency expects to release the 2016 GA survey by October 31, 2017.
    Director: Gomez, Jose A
    Phone: (202)512-2649

    1 open recommendations
    Recommendation: To enhance FDA's oversight of dietary supplements and foods with added dietary ingredients, and to better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, the Secretary of the Department of Health and Human Services should direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2011, FDA published draft guidance for industry on new dietary ingredient notifications and related issues. This draft guidance includes information on when a dietary ingredient is considered new, evidence of safety, and methods for ingredient identity. We are waiting for the draft guidance to become final to close the recommendation.
    Director: Crosse, Marcia G
    Phone: (202)512-3407

    1 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has taken steps to respond to this recommendation; however we are leaving the recommendation open because the agency has not yet taken final steps to reclassify or require premarket approval (PMA) for two class III device types allowed to enter the market through the less stringent 510(k) process. In 2009, FDA began a 5-step process to reclassify or to require PMAs for 26 class III device types. This process was modified by the Food and Drug Administration Safety and Innovation Act (FDASIA)--instead of issuing regulations as the final step, FDA issues an administrative order to reclassify or require PMAs for the device types. In 2014, the agency reported it had set a goal to have all remaining devices finalized by the second quarter of 2015; however, as of August 2017, FDA had not finished the process of reclassifying or requiring PMAs for 2 of 26 devices types. The agency reported completing the process for 24 device types, and provided new planned milestones to complete the process for the remaining device types by the middle of 2018. We will leave this recommendation open until FDA makes progress in reclassifying or requiring PMAs for the remaining device types.
    Director: Kingsbury, Nancy R
    Phone: (202)512-6570

    4 open recommendations
    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: 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 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: 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.
    Director: Trimble, David C
    Phone: (202)512-6225

    2 open recommendations
    Recommendation: Congress may wish to consider amending CSB's authorizing statute or the Inspector General Act of 1978 to permanently give Environmental Protection Agency's (EPA) Inspector General the authority to serve as the oversight body for the agency.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action yet.
    Recommendation: As Congress prepares the appropriation of the EPA Inspector General, it may wish to consider providing the Inspector General with appropriations and staff allocations specifically for the audit function of CSB via a direct line in the EPA appropriation.

    Agency: Congress
    Status: Open

    Comments: Congress has not taken action yet.
    Director: Siggerud, Katherine A
    Phone: (202)512-3000

    1 open recommendations
    Recommendation: Taking action to address the challenges FMCSA faces to ensure that its drug testing program detects drivers who are using illegal drugs, and to keep drivers who have tested positive off the road until they have completed the return-to-duty process, provides an opportunity to improve safety on the roads. In order to assist the Department of Transportation (DOT) and FMCSA in addressing these challenges, and thereby improving road safety, Congress may wish to consider adopting legislation to ban subversion products.

    Agency: Congress
    Status: Open

    Comments: On February 4, 2009, Representative Engel introduced the Drug Testing Integrity Act of 2009 in the House of Representatives. The Act would ban products designed to defraud drug tests. On February 15, 2011 Representative Engel re-introduced the bill, which was referred to the House Committee on Energy and Commerce and then to the Subcommittee on Commerce, Manufacturing, and Trade. Representative Engel re-introduced the bill in the 113th Congress in May of 2013. However, the bill has not been reintroduced since.
    Director: Siggerud, Katherine A
    Phone: (202)512-6570

    1 open recommendations
    Recommendation: To better demonstrate how FMCSA education and outreach programs contribute to achieving agency goals, the Secretary of Transportation should direct the Administrator of FMCSA to ensure that the agency describes and documents how education and outreach program activities link to and support broader program and agency goals in a planning, program, or budget document that is available to the public.

    Agency: Department of Transportation
    Status: Open

    Comments: In response to GAO's recommendation that the agency describe and document how education and outreach program activities link to and support broader program goals, FMCSA included discussion of how their education and outreach activities supported a number of programs in its FY 2009 performance budget in response to GAO. FMCSA also provided more detailed logic models to GAO on the education and outreach activities that support a number of their programs such as New and Non Entrants, Share the Road Safely and Safety Belt Usage Improvement.
    Director: Dyckman, Lawrence J
    Phone: (202)512-9692

    1 open recommendations
    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 established a national Food Safety Commission charged with making specific recommendations for drafting legislative language. Among other things, the Commission is 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 DOF report. As of January 2017, no action had been taken. Therefore, in January 2017, we reopened this matter.