Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, resolve agency-wide disagreements on the roles and responsibilities for the centers and OLS in implementing laboratory safety reforms. (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 Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, address issues of duplication, overlap, and fragmentation within the safety program. (Recommendation 2)

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 Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, identify how FDA leadership will communicate agency-wide on a sustained basis about the importance of laboratory safety and OLS's role in ensuring successful implementation of laboratory safety reforms. (Recommendation 3)

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 Commissioner of FDA should provide OLS—as FDA's laboratory oversight body—with the necessary oversight authority and access to laboratories to oversee FDA's laboratory safety program and ensure compliance with the agency's laboratory safety policies. (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 Commissioner of FDA should take steps to assess and mitigate any risks to independence posed by funding OLS—as FDA's laboratory safety oversight body—through the working capital fund. In conducting its risk assessment, FDA should specifically focus on ensuring the decision-making processes of the working capital fund supports OLS's independence and ability to hire sufficient staff to implement its laboratory safety oversight priorities. (Recommendation 5)

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 Secretary of Health and Human Services should develop a mechanism to routinely monitor, evaluate, and report on coordination efforts for infectious disease modeling across multiple agencies. (Recommendation 1)

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services concurred with this recommendation and stated that it is developing a process whereby it will coordinate its efforts in infectious disease modeling across its components, including efforts to monitor, evaluate and report on its coordination. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Secretary of Health and Human Services should direct CDC to establish guidelines that ensure full reproducibility of CDC's research by sharing with the public all permissible and appropriate information needed to reproduce research results, including, but not limited to, model code. (Recommendation 2)

Agency: Department of Health and Human Services
Status: Open

Comments: The Centers for Disease Control and Prevention concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Administrator of the Food Safety and Inspection Service (FSIS) should document the agency's process for deciding which products to consider for new pathogen standards, including the basis on which such decisions should be made. (Recommendation 1).

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

Comments: As of September 2019, FSIS is drafting a document that will outline the agency's process for deciding which products to consider for new pathogen standards, including the basis on which such decisions should be made. FSIS estimates the document will be finalized in the fourth quarter of fiscal year 2020. As of October 2020, FSIS has not completed this action.

Recommendation: The Administrator of FSIS should set time frames for determining what pathogen standards or additional policies are needed to address pathogens in beef carcasses, ground beef, pork cuts, and ground pork. (Recommendation 2).

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

Comments: In October 2019, FSIS proposed new pathogen reduction performance standards for Salmonella in raw ground beef and beef trimmings. FSIS told us the agency is developing performance standards for some pork products and plans to issue draft standards sometime in fiscal year 2020 but as of October 2020 has not completed this action.

Recommendation: The Administrator of FSIS should include available information on the effectiveness of on-farm practices to reduce the level of pathogens as it finalizes its guidelines for controlling Salmonella in hogs. (Recommendation 3).

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

Comments: As of September 2019, FSIS is revising its draft guidelines for controlling Salmonella in hogs. The agency plans to include in the guidelines available scientific information on the effectiveness of on-farm practices to reduce Salmonella. FSIS estimates it will complete its revision of the guidelines in the fourth quarter of fiscal year 2020 but as of October 2020 has not completed this action.

Recommendation: To improve technical expertise and overcome fragmentation, the CDC director of the Select Agent Program should work with APHIS to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 10)

Agency: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention
Status: Open

Comments: CDC agreed with this October 2017 recommendation and, as of January 2020, CDC and APHIS were in the process of finalizing a joint workforce assessment focusing primarily on inspections, according to officials from the Select Agent Program. However, this joint assessment does not account for other aspects of the program, such as training, which was part of GAO's recommendation. According to Select Agent Program officials, the program is developing a new information system and officials plan to conduct a follow-up workload assessment once this new system is fully implemented, as they anticipate that the program will gain efficiencies once this new system is in place. Officials from the Select Agent Program said they did not have a definitive timeframe as to when the new system would be in place and a new workload assessment could be completed but, as of December 2019, they said it would be several years. Once the updated workforce assessment is completed, GAO will review it to determine if it fulfills the recommendation. Developing a joint workforce plan as recommended would help the program to better manage fragmentation by improving how it leverages resources, which in turn would help to ensure that all workforce and training needs are met.

Recommendation: To improve technical expertise and overcome fragmentation, the APHIS director of the Select Agent Program should work with CDC to develop a joint workforce plan that assesses workforce and training needs for the program as a whole. This assessment should be done in conjunction with the development of the strategic plan. (Recommendation 11)

Agency: Department of Agriculture: Animal and Plant Health Inspection Service
Status: Open

Comments: APHIS agreed with this October 2017 recommendation and, as of January 2020, CDC and APHIS were in the process of finalizing a joint workforce assessment focusing primarily on inspections, according to officials from the Select Agent Program. However, this joint assessment does not account for other aspects of the program, such as training, which was part of GAO's recommendation. According to Select Agent Program officials, the program is developing a new information system and officials plan to conduct a follow-up workload assessment once this new system is fully implemented, as they anticipate that the program will gain efficiencies once this new system is in place. Officials from the Select Agent Program said they did not have a definitive timeframe as to when the new system would be in place and a new workload assessment could be completed but, as of December 2019, they said it would be several years. Once the updated workforce assessment is completed, GAO will review it to determine if it fulfills the recommendation. Developing a joint workforce plan as recommended would help the program to better manage fragmentation by improving how it leverages resources, which in turn would help to ensure that all workforce and training needs are met.

Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Health and Human Services should direct the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) to develop clear definitions of inactivation for use within their respective guidance documents that are consistent across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

Agency: Department of Health and Human Services
Status: Open

Comments: As of April 2020, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) within the Department of Health and Human Service (HHS) are taking steps to address this recommendation. Specifically, in January and March 2017, HHS, in collaboration with the United States Department of Agriculture (USDA), issued updated select agent regulations and guidance that included clear definitions of inactivation and a validated inactivation procedure that are consistent across the Federal Select Agent Program. Additionally, HHS stated in December 2016 that NIH will consider providing clear and consistent definitions of inactivation in future guidance that is harmonized with the select agent regulations. Moreover, NIH and CDC told us they plan to include a new appendix in the revised Biosafety in Microbiological and Biomedical Laboratories manual that specifically addresses the development, validation, and implementation of inactivation protocols, which they anticipate releasing in June 2020, according to a CDC official.

Recommendation: To help ensure that inactivation protocols are scientifically sound and are effectively implemented, the Secretary of Health and Human Services should direct CDC and NIH to create comprehensive and consistent guidance for the development, validation, and implementation of inactivation protocols--to include the application of safeguards--across the Select Agent Program, NIH's oversight of recombinant pathogens, and the Biosafety in Microbiological and Biomedical Laboratories manual.

Agency: Department of Health and Human Services
Status: Open

Comments: In March 2017, the Department of Health and Human Services (HHS), in collaboration with the United States Department of Agriculture (USDA), issued Federal Select Agent Program guidance on the inactivation of select agents and toxins. According to HHS, this guidance is intended to provide additional information to regulated entities to assist them in meeting new requirements for rendering samples with select agents as non-viable. HHS also stated that the Federal Select Agent Program will continue to work with other federal agencies to ensure that the federal government is addressing inactivation in a consistent manner. In addition, according to HHS, the National Institutes of Health (NIH) will consider providing clear and consistent guidance related to inactivation that is harmonized with the Federal Select Agent Program as appropriate. As of April 2020, NIH and the Centers for Disease Control and Prevention (CDC) were in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses the development, validation, and implementation of inactivation protocols. HHS plans to release the updated manual in June 2020, according to a CDC official.

Recommendation: To help ensure that dangerous pathogens can be located in the event there is an incident involving incomplete inactivation, the Secretary of Health and Human Services should direct the Directors of CDC and NIH, when updating the Biosafety in Microbiological and Biomedical Laboratories manual, to include guidance on documenting the shipment of inactivated material.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) stated in March 2017 that the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) are in the process of revising the Biosafety in Microbiological and Biomedical Laboratories manual to include a new appendix that addresses inactivation methods, including guidance on documenting the shipment of inactivated material. HHS plans to release the updated manual in June 2020, according to a CDC official.