Recommendation: The Assistant Secretary for Countering Weapons of Mass Destruction should develop a strategy and implementation plan to help the Department of Homeland Security, among other things, guide, support, integrate and coordinate its chemical defense programs and activities; leverage resources and capabilities; and provide a roadmap for addressing any identified gaps. (Recommendation 1)

Agency: Department of Homeland Security: Countering Weapons of Mass Destruction Office
Status: Open
Priority recommendation

Comments: DHS agreed with GAO's September 2018 recommendation and is taking actions to address it. Countering Weapons of Mass Destruction Office (CWMD) officials stated in December 2018 that CWMD plans to develop a strategy and implementation plan to help DHS guide, support, integrate and coordinate its chemical defense programs and activities; leverage resources and capabilities; and provide a roadmap for addressing any identified gaps. According to CWMD officials, the implementation plan would broadly address DHS chemical defense activities and programs to prevent, protect against, and respond to chemical incidents, including support to federal, state, tribal, and territorial operators and agencies, as well as the private sector. CWMD officials provided GAO with the completed strategy in December 2019 and plan to complete the implementation plan by December 2020. The strategy includes four overarching goals that will drive CWMD's mission in protecting American safety and security from chemical threats and incidents. We will continue to monitor the status of the implementation plan, as completion of both documents is essential to help the CWMD Office guide DHS's efforts to address fragmentation and coordination issues and would be consistent with the office's aim to establish a coherent mission.

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.

Recommendation: To develop timely chemical risk information that EPA needs to effectively conduct its mission, the Administrator, EPA, should require the Office of Research and Development to re-evaluate its draft proposed changes to the IRIS assessment process in light of the issues raised in this report and ensure that any revised process periodically assesses the level of resources that should be dedicated to this significant program to meet user needs and maintain a viable IRIS database.

Agency: Environmental Protection Agency
Status: Open
Priority recommendation

Comments: As of February 2020, EPA officials indicated that the IRIS Program had almost completed internal review of a "Handbook for Developing IRIS Assessments," intended to guide staff through the sequential stages of the IRIS assessment process and ensure consistency across assessments. The Handbook, when finalized and used by staff, codifies the agency's effort to reevaluate their assessment process, but doesn't address the resources that should be dedicated to the IRIS Program. A workforce plan that includes both staff and budget resources consistent with user needs is necessary. As we reported in March 2019, the program has made strides utilizing project management software and project management techniques that enable the IRIS Program to better plan assessment schedules and utilize staff. However, we also reported in March 2019 that the President's budget requests since fiscal year 2018 have repeatedly cut the budget by as much as 40 percent for the Health and Environmental Risk Assessment (HERA) area, of which IRIS is a part. While these cuts were not enacted by Congress, the President's fiscal year 2021 budget request again cuts the HERA program by 34 percent, or approximately $12.7 million dollars. These cuts could have an impact on the IRIS program's ability to meet EPA program and regional office needs, if enacted by Congress.