Select Agents and Toxins

Archive Select Agents and Toxins Archive

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In each CMP case resolved through a settlement agreement, the settling party has contested the OIG's allegations and denied any liability. No CMP judgment or finding of liability has been made against the settling party.


A Texas University agreed to pay $1 million to resolve its liability for numerous violations of the select agent regulations. OIG’s allegations included the following: failure of the university’s Responsible Official (RO) to apply for an amendment to the university’s certificate of registration; failure of the RO to receive the necessary approval prior to university researchers conducting aerolization experiments with select agents; failure of the RO to be familiar with and ensure compliance with the requirements of the select agent regulations; failure of the RO to ensure that deficiencies identified during annual inspections were corrected; failure to obtain CDC approval to conduct restricted experiments with a select agent; allowing researchers, on multiple occasions, to have access to select agents without prior CDC approval and without having the appropriate education, training, and/or experience to handle or use select agents; failure to investigate whether elevated titers of three laboratory workers were caused by occupational exposure to a select agent; failure to ensure that appropriate biosafety and security plans were implemented; failure to ensure that laboratory personnel were trained in biosafety and security; failure to maintain a current list of individuals with access approval to select agents and toxins; failure to keep records of access to at least seven laboratory rooms where select agent work was conducted; failure to implement an accurate record keeping system for its select agent inventory; and failure to report occupational exposures to select agents.

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