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Archives - 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.

2007

10-02-2007
A Virginia corporation agreed to pay $50,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the corporation violated the select agent regulations in the following ways: (1) failing to meet biosafety and security standards appropriate for a select toxin; (2) storing packaged, regulated toxins to be shipped in an unsecured, unregistered location before shipping, which allowed unrestricted access to the toxins; (3) having an inadequate incident response plan; and (4) failing to provide and document the required annual select agent training.
09-24-2007
A California laboratory agreed to pay $450,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the laboratory transferred vials of a select agent to two laboratories located in Florida and Virginia. During the transfers, the select agent was released from the shipped vials. An investigation of the packaging for the shipments revealed several violations of regulations governing the shipment of the select agent. The OIG alleged that the laboratory violated the transfer requirements of the select agent regulations by failing to comply with the applicable shipping and packaging laws when transferring a select agent. In addition, the OIG also alleged that the laboratory failed to comply with security and access requirements by allowing an individual not authorized to have access to select agents to package the shipments of the select agent, and that the laboratory's Responsible Official failed to ensure compliance with the shipping and packaging requirements of the select agent regulations.
04-30-2007
A Missouri corporation agreed to pay $25,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the corporation violated the select agent regulations by making two unauthorized transfers of select agents. Specifically, the OIG alleged that the corporation sent a select agent to a university which was not registered with the CDC to possess, use, or transfer this select agent. In addition, the OIG alleged that the corporation sent the select agent to a laboratory without obtaining prior authorization from DSAT for the transfer.
02-27-2007
A California Institute agreed to pay $50,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the Institute violated the select agent regulations in the following ways: (1) synthesized and possessed a select agent before obtaining a certificate of registration from the Centers for Disease Control and Prevention, and (2) violated transfer requirements related to the Institute's possession of the select agent.

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2006

12-18-2006
A Florida corporation agreed to pay $15,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the corporation violated the select agent regulations by receiving a transfer of a select agent from another entity without first obtaining authorization from the Centers for Disease Control and Prevention (CDC) and by failing to provide necessary paperwork to the CDC within two business days of receiving the select agent.
10-10-2006
A South Carolina university agreed to pay $50,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the university violated the select agent regulations in the following ways: (1) failure of Responsible Official to apply for an amendment to the university's Certificate of Registration; (2) inadequate security plan; (3) inadequate biosafety plan; (4) inadequate incident response plan; (5) failure to maintain adequate training records; and (6) failure to maintain adequate inspection and inventory records.

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2005

12-05-2005
A Pennsylvania corporation agreed to pay $15,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the corporation violated the select agent regulations by possessing a select agent without filing for a certificate of registration with the Centers for Disease Control and Prevention.
11-07-2005
A Maryland institute agreed to pay $150,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the institute made an unauthorized transfer of a select agent to an unregistered entity. The unregistered entity, a research facility, had requested that the institute send it nonviable cells of the select agent. The preparations that the institute sent, however, contained viable spores of the select agent.
09-28-2005
A Colorado research center agreed to pay $20,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the research center made an unauthorized transfer of a select agent to a corporation, without first obtaining authorization from the Centers for Disease Control and Prevention.
05-23-2005
A Minnesota corporation agreed to pay $12,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the corporation possessed a select agent from March 12, 2003 until July 17, 2004. The OIG alleged that during this time, the corporation failed to submit application materials and failed to register with the Centers for Disease Control and Prevention.

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2004

07-26-2004
An Ohio corporation agreed to pay $50,000 to resolve its liability for an alleged violation of the select agent regulations. The OIG alleged that the corporation possessed a select agent from at least March 12, 2003 until March 4, 2004. The OIG alleged that during this time, the corporation failed to submit application materials, and failed to properly register, with the Centers for Disease Control and Prevention

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