HIGH-CONTAINMENT LABS: Improved Oversight of Dangerous Pathogens Needed to Mitigate Risk

The total number of incidents involving incomplete inactivation—a process to destroy the hazardous effects of pathogens while retaining characteristics for future use—that occurred from 2003 through 2015 is unknown for several reasons. One key reason is that the Select Agent Program—operated by the Departments of Health and Human Services (HHS) and Agriculture (USDA) to oversee certain dangerous pathogens, known as select agents—does not require laboratories to identify such incidents on reporting forms. According to the program, 10 incidents occurred from 2003 through 2015. However, GAO identified an additional 11 incidents that the program did not initially identify. Because the program cannot easily identify incidents involving incomplete inactivation, it does not know the frequency or reason they occur, making it difficult to develop guidance to help mitigate future incidents. The 21 identified incidents involved a variety of pathogens and laboratories, as shown below.

REFERENCE:
HIGH-CONTAINMENT LABORATORIES: Improved Oversight of Dangerous Pathogens Needed to Mitigate Risk. GAO-16-642: Published: Aug 30, 2016. Publicly Released: Sep 21, 2016.
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