Reports & Testimonies

  • GAO’s recommendations database contains report recommendations that still need to be addressed.

    GAO’s recommendations help congressional and agency leaders prepare for appropriations and oversight activities, as well as help improve government operations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented. You can explore open recommendations by searching or browsing.

    GAO's priority recommendations are those that we believe warrant priority attention. We sent letters to the heads of key departments and agencies, urging them to continue focusing on these issues. These recommendations are labeled as such. You can find priority recommendations by searching or browsing our open recommendations below, or through our mobile app.

  • Browse Open Recommendations

    Explore priority recommendations by subject terms or browse by federal agency

    Search Open Recommendations

    Search for a specific priority recommendation by word or phrase



  • Governing on the go?

    Our Priorities for Policy Makers app makes it easier for leaders to search our recommendations on the go.

    See the November 10th Press Release


  • Have a Question about a Recommendation?

    • For questions about a specific recommendation, contact the person or office listed with the recommendation.
    • For general information about recommendations, contact GAO's Audit Policy and Quality Assurance office at (202) 512-6100 or apqa@gao.gov.
  • « Back to Results List Sort by   

    Results:

    Subject Term: "Product safety"

    15 publications with a total of 25 open recommendations including 2 priority recommendations
    Director: Steve Morris
    Phone: (202) 512-3841

    5 open recommendations
    Recommendation: The Commissioner of FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. (Recommendation 1)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of FSIS should ensure that agency staff doing an on-site audit in another country for an equivalence determination visit at least a sample of farms whose catfish are exported to the United States to determine the conditions under which the catfish are being raised, including the drugs being used. (Recommendation 2)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of FSIS should require as part of an equivalence determination that countries exporting catfish to the United States include in their residue monitoring plans the drugs of concern to FSIS and the corresponding maximum residue levels. (Recommendation 3)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: The Administrator of FSIS should coordinate and communicate with FDA in developing drug residue testing methods and corresponding maximum residue levels for imported catfish that may also be applicable to other imported seafood. (Recommendation 5)

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    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: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

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

    Comments: HHS concurred with this recommendation and stated that FDA plans to conduct internal annual reviews of its foreign offices' performances and track their contributions by type of commodity. We will assess these actions once they have been completed.
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its OIP strategic workforce plan, the Commissioner of FDA should establish goals to achieve the appropriate staffing level for its foreign offices, which would include separating foreign office vacancies from the OIP-wide vacancy rate, and setting goals by position type.

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

    Comments: HHS concurred with this recommendation. HHS said that the strategic workforce plan for FDA's foreign offices will be updated to reflect the disaggregation of performance measures that track foreign office vacancy rates and targets by position type. We will assess these actions once they have been completed.
    Director: Steve Morris
    Phone: (202) 512-3841

    1 open recommendations
    Recommendation: To further enhance FDA's PREDICT tool and its ability to ensure the safety of imported food, the Secretary of Health and Human Services should direct the Commissioner of FDA to document the process for identifying the type of open source data to collect, obtaining such data, and determining how PREDICT is to use the data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of February 2017, GAO was awaiting action by the agency to implement this recommendation.
    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: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to modify the voluntary reporting form FDA uses to obtain information on adverse events to ask whether drugs involved in adverse events were compounded.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA has drafted a notice for publication in the Federal Register that seeks comment on editorial revisions to Form FDA 1932a to clarify how to report adverse drug events associated with compounded products using that form. The publication of the notice was issued in July 2017. After a 60-day public comment period, the revisions to Form FDA 1932a will be submitted to OMB for review and approval under the Paperwork Reduction Act.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2017, FDA notified us that they are still in the process of developing guidance for agency staff that specifies circumstances under which FDA will enforce compounding regulations for animals. According to FDA, the agency received more than 150 comments regarding the draft Guide For Industry #230 and 280 nominations of bulk drug substances for use in compounding office stock; information necessary for updating the guidance. In addition, FDA is reviewing the substances that were nominated for use in compounding office stock. Officials did not provide a specific timeline for completing this work, but stated that developing updated guidance on compounding for animals continues to be a high priority for FDA.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA reported that it is still developing an enforcement strategy for compounded animal drugs that includes a process for documenting the Agency's actions with respect to follow-up on warning letters, adverse event reports, and complaints.
    Director: J. Alfredo Gómez
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

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

    Comments: In January 2015, we recommended that the Commissioner of FDA complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. Additionally, if the inspection numbers from that analysis are different from the inspection targets mandated in the FDA Food Safety Modernization Act (FSMA), FDA should report the results to Congress and recommend appropriate legislative changes. At the time of our report, FDA was not keeping pace with FSMA's mandate to increase inspections each year from 2011 through 2016. In April 2017, FDA indicated that that it does not anticipate going significantly beyond 1,200 foreign food facilities inspections per year, based on the amount of additional funding needed to meet the foreign inspection requirement of FSMA. However, FDA has not conducted an analysis to determine whether the increased number of inspections mandated by FSMA or the lower number of inspections it is currently conducting is sufficient to ensure comparable safety of imported and domestic food. FDA noted that, in January 2017, it began an analysis to define and describe the global inventory of human and animal food firms and examine the application of regulatory oversight tools across the inventory. According to FDA, the analysis will help it assess the annual number of foreign food facility inspections as part of an overall risk-based allocation of resources for ensuring that imported foods are produced in a manner the meets applicable U.S. safety standards. We continue to believe that FDA should complete such an analysis and report the results to Congress.
    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: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

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

    Comments: In August 2017, FDA reported that it had not conducted any rigorous analysis of predictors of drug shortages nor have new drug risk factors been identified. Although FDA adopted a new, commercially developed data system, the "Shortage Tracker" to track drug shortages in March 2016, it is used to help the Drug Shortage Staff manage their workload. FDA reported that this system has now been fully operational for over a year. However, no trend analysis relating to drug shortages has been conducted and the agency has no plans to conduct such analyses at this time.
    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: Cackley, Alicia P
    Phone: (202) 512-8678

    1 open recommendations
    Recommendation: To better enable CPSC to target unsafe consumer products, Congress may wish to amend section 29(f) of CPSA to allow CPSC greater ability to enter into information-sharing agreements with its foreign counterparts that permit reciprocal terms on disclosure of nonpublic information.

    Agency: Congress
    Status: Open

    Comments: As of July 31, 2017, Section 29 of CPSA had not been amended since 2008. In 2013, a bill was introduced (S.1887) but not passed. That bill would have allowed "the Commission, when sharing information under the federal-state cooperation program with a foreign government agency for official law enforcement or consumer protection purposes, to authorize a foreign government agency to make that information available to another agency of the same foreign government (including a political subdivision of that foreign government that is located within the same territory or administrative area as the agency disclosing the information) if an appropriate official of the foreign government agency disclosing the information certifies (by prior agreement, memorandum of understanding with the CPSC, or other written certification) that it will establish and apply specified confidentiality restrictions under the Consumer Product Safety Act."
    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: 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: 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.