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    Subject Term: "Chemical agents"

    3 publications with a total of 13 open recommendations including 1 priority recommendation
    Director: Persons, Timothy M
    Phone: (202) 512-6412

    9 open recommendations
    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 July 2017, 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 2 to 3 years.
    Recommendation: To understand the extent to which incomplete inactivation occurs and whether incidents are being properly identified, analyzed, and addressed, the Secretary of Agriculture should direct APHIS to revise reporting forms to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017.
    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 CDC and NIH to revise reporting forms within their respective areas of oversight to help identify when incidents involving incomplete inactivation occur and analyze the information reported to help identify the causes of incomplete inactivation to mitigate the risk of future incidents.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, officials from the Federal Select Agent Program told us that they are in the process of modifying the program's incident reporting form to include reporting of inactivation failures, with completion anticipated by summer 2017. In addition, in August 2016, the National Institutes of Health (NIH) revised its template for reporting incidents subject to the NIH Guidelines to include a specific checkbox for entities to identify incidents that involve incomplete inactivation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Agriculture
    Status: Open

    Comments: In March 2017, United States Department of Agriculture (USDA) officials stated that the department, in coordination with the Department of Health and Human Services (HHS), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    Recommendation: To increase scientific information on inactivation and viability testing, the Secretaries of Health and Human Services and Agriculture should coordinate research efforts and take actions to help close gaps in the science of inactivation and viability testing across high-containment laboratories.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In March 2017, Department of Health and Human Services (HHS) officials stated that the department, in coordination with the United States Department of Agriculture (USDA), has examined current gaps related to inactivation and are in the process of taking steps to increase research on applied biosafety, in part to improve scientific understanding of processes for inactivation in high-containment laboratories. We are waiting for documentation and timeframes for implementation.
    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 March 2017, 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 2 to 3 years.
    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 by 2020. HHS plans to release the updated manual in 2 to 3 years.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Agriculture should direct APHIS to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Agriculture
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    Recommendation: To help ensure more consistent enforcement for violations involving incomplete inactivation of select agents, the Secretary of Health and Human Services should direct CDC to develop and implement consistent criteria and documentation requirements for referring violations to investigative entities and enforcing regulations related to incidents involving incomplete inactivation.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In September 2017, the Federal Select Agent Program finalized a document that provides criteria on when to refer violations and options for enforcement. The document categorizes regulatory departures, grouped by level of risk, along a spectrum of severity with associated enforcement options. In addition, the Centers for Disease Control and Prevention worked with the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to develop a policy document that outlines criteria for referring violations to the HHS OIG. One of the criterion for referral is any departure from the select agent regulations that creates a danger to public health and safety. This policy document was finalized in June 2017. The program continues to develop associated documentation requirements for referring violations to investigative entities and enforcing regulations.
    Director: Joseph Kirschbaum
    Phone: (202) 512-9971

    3 open recommendations
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to fully institutionalize the use of risk assessments to support future investment decisions, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to update the roles and responsibilities guidance in DOD Directive 5160.05E to identify which organizations are responsible for conducting and participating in CBDP Enterprise risk assessments.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. As of August 2017, DOD was still waiting to release the final version of DOO Directive 5160.05E.
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to fully institutionalize the use of risk assessments to support future investment decisions, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to update the CBDP Enterprise's portfolio planning process, to include when risk assessments will be conducted.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. On 6/8/16, DOD reported that the risk assessment process was initially piloted in 2014 to determine its utility for informing CBDP Enterprise portfolio planning and guidance. Moving forward, the CBDP Enterprise plans to conduct risk assessments annually to support portfolio planning and guidance. As of August 2017, DOD reported that the department was beginning an approximately 12-month process to revise the CBDP Business Plan, which would likely be published as a DOD Instruction. This plan should address the risk assessment recommendation.
    Recommendation: To improve the identification, alignment, and management of DOD's chemical and biological defense infrastructure and to enhance PAIO's ongoing analysis of potential infrastructure duplication in the CBDP Enterprise and gain potential efficiencies, the Secretary of Defense should direct the Under Secretary of Defense for Acquisition, Technology and Logistics to identify, request, and consider any information from existing infrastructure studies from other federal agencies with chemical and biological research and development and test and evaluation infrastructure.

    Agency: Department of Defense
    Status: Open

    Comments: DOD concurred with this recommendation but has not yet completed actions to implement it. As of July 2017, DOD has requested, but not received, such studies from other federal agencies. However, DOD is currently engaged in phase two of a three-phase effort regarding its chemical and biological defense infrastructure program (CBDP), which includes a review of the department's interagency roles and responsibilities for its chemical and biological defense Infrastructure Manager. Targeted completion for this phase is December 2017, at which time, DOD may have obtained relevant information from other federal agencies.
    Director: Trimble, David C
    Phone: (202)512-6225

    1 open recommendations
    including 1 priority recommendation
    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: In October 2016 we reviewed information provided by EPA related to this recommendation. The issuance of the Integrated Risk Information System (IRIS) Program Multi-Year Agenda in December 2015 demonstrated progress in responding to this recommendation. While we are currently reviewing additional documentation on how the agenda development process assessed the level of resources needed to meet user demand and to maintain a viable IRIS database, we will reevaluate how EPA continues to document the level of resources dedicated to this program to determine whether updates are occurring periodically.