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Health & Safety Manual - Biological Safety

2.10 Select Agents and Toxins; Biosecurity

2.10.1 Select Agents and Toxins
2.10.2 Biosecurity

2.10.1 Select Agents and Toxins
Select Agents and Toxins are high risk microorganisms (BSL-3 and 4 agents) and toxins that may pose a public health threat to individuals, animals, or plants due to accidental or intentional release.  Their use and possession must be consistent with biological safety and biosecurity requirements promulgated by the USDA and/or CDC.  Laboratories wishing to acquire and use Select Agent microorganisms or toxins must first obtain CDC or USDA approval by demonstrating that the materials will be used in appropriately engineered facilities, with adequate security.  Approval is also contingent upon demonstration of appropriate SOPs relating to security, incident and emergency response.

A list of Select Agent microorganisms can be found at the National Select Agents Registry site http://www.selectagents.gov/SelectAgentsand
ToxinsList.html.

For Select Agent toxins, quantity limits exist.  Laboratories possessing amounts below these limits are exempt from the CDC/USDA approval process. It is presumed that no laboratory at Columbia will need to use any of these toxins above the quantity limits, however manufacturers and suppliers often require documented attestation of quantity limit compliance when ordering any quantity of a Select Agent toxin.  Please contact EH&S if you are requested to provide such documentation.  

Refer to EH&S’ website for a summary (http://www.ehs.columbia.edu/SelectAgents.html) of the requirements for the use of Select Agents and Toxins. 

2.10.2 Biosecurity

The need to safeguard and limit access to biological materials is not limited to laboratories using Select Agent materials. Consult the Principles of Laboratory Biosecurity section (http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_VI.pdf) of the BMBL 5 for guidance in establishing laboratory-specific biosecurity procedures.

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