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Select Agent Material Accountability

 

 The Responsible Official (RO) and Alternate Responsible Official (ARO) are required by federal regulations (42 CFR 73.17) to maintain complete records relating to select agent or toxin activities.  All records of select agent use will be achieved by using records with diligent quality assurance and accountability measures taken by the Principal Investigator (PI) and designated agent/s.  The PI will be responsible for training and ensuring the proper use of entry formatting to ensure that all entries are legible, complete, signed, dated and that all corrections are made properly.

Accurate records for select agents and toxins must include: 

  • Name and characteristics
  • Quantity acquired, date of acquisition, source
  • Quantity, volume or mass destroyed or otherwise disposed of and the date of each action
  • Where agent or toxin is stored (building, room, freezer, box)
  • When the agent or toxin is moved from storage and by whom and when agent returned to storage and by whom
  • The select agent used and propose of use 
  • Record of transfers:  For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent or toxin, the quantity transferred, the date of transfer, the sender, and the recipient.
  • Any select agent or toxin lost, stolen, or otherwise unaccounted for and written explanation of any  discrepancies
  • Names of individuals who have accessed the area where select agents and toxins are stored or used (name of the escort if applicable)
  • Date and time individual entered the area

The Office of Biosafety will conduct quarterly inventory audits of all select agent laboratories.  All inventory records as well as all transfer documents (APHIS/CDC Form 2) and permits will be maintained by the Office of Biosafety.  Select Agent and Toxin Inventory Forms can be downloaded here:  

 

 

Office of Biosafety, Tulane University, New Orleans, LA 70112 504-988-0300 ibc@tulane.edu