Recommendation: The NMFS Assistant Administrator for Fisheries should work with the South Atlantic and Gulf of Mexico councils, and other councils as appropriate, to develop documented processes for conducting allocation reviews. (Recommendation 1)

Agency: Department of Commerce: National Oceanic and Atmospheric Administration: National Marine Fisheries Service
Status: Open

Comments: Commerce and NOAA agreed with this recommendation and stated that NOAA's NMFS will work to implement it to the extent possible. We will continue to monitor NMFS' efforts to do so.

Recommendation: The NMFS Assistant Administrator for Fisheries should work with the South Atlantic and Gulf of Mexico councils, and other councils as appropriate, to specify how the councils will document their allocation reviews, including the basis for their allocation decisions, whether fishery management plan objectives are being met, and what factors were considered in the reviews. (Recommendation 2)

Agency: Department of Commerce: National Oceanic and Atmospheric Administration: National Marine Fisheries Service
Status: Open

Comments: Commerce and NOAA agreed with this recommendation and stated that NOAA's NMFS will work to implement it to the extent possible. We will continue to monitor NMFS' efforts to do so.

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.