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Select Agents and Toxins

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.

2014

04-25-2014
An Arizona research university agreed to pay $165,000.00 to resolve its liability for violating the select agent regulations by failing to: (1) maintain current and accurate inventory records regarding certain select agents; (2) implement biosafety and containment procedures commensurate with the risks associated with the select agents and toxins in its possession; and (3) failed to ensure compliance with the requirement of 42 C.F.R. Part 73.

2011

12-19-2011
An Alabama non-profit organization agreed to pay $25,000 to resolve its liability for violating the select agent regulations by failing to comply with authorized transferred requirements as it pertained to receiving an international shipment of select agents without prior Center for Disease Control authorization.
06-29-2011
A California registered entity entered into a settlement for $50,000 to resolve its liability under the Public Health Security and Bioterrorism Preparedness and Response Act, 42 U.S.C. § 262a, and 42 C.F.R. § 73.21, which authorizes a civil monetary penalty for violations of the select agent regulations, 42 C.F.R. Part 73. The alleged violations related to the entity's possession, use, or transfer of a regulated toxin without a valid certificate of registration; receipt of a regulated toxin without prior approval; unauthorized access to a regulated toxin; and failure to have an inventory system that accurately accounted for the regulated toxin inventory.

2010

05-25-2010
A South Dakota laboratory agreed to pay $40,000 to resolve its liability for violating the select agent regulations. The OIG alleged that the laboratory allowed several individuals unauthorized access to areas where select agents and toxins were stored and failed to secure a refrigerator and freezer containing select agents and toxins.

2009

10-26-2009
A Wisconsin university agreed to pay $40,000 to resolve its liability for violating the select agent regulations. OIG alleged that the university conducted restricted experiments with a select agent without obtaining prior approval from CDC, as required by the select agent regulations. The university self-disclosed these unauthorized experiments to CDC, and fully cooperated in the investigation of this matter.
03-06-2009
A Missouri company agreed to pay $110,000 to resolve allegations that it violated the select agent regulations by engaging in three unauthorized transfers of select agents and by submitting documents to the CDC that indicated two of the transfers had not yet occurred when in fact the entity had already received the agents.

2008

08-16-2008
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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Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201