AOAC SPADA Meeting

Bacterial Verification

Example

E. coli  contains strains that are BSL‐1 and BSL‐2.  Failure to identify a BSL‐2 strain can put lab. workers at risk.

Failure to identify a strain that requires a USDA permit can be in violation of  USDA regulations if your lab is  not USDA inspected.  You should not be transferring the strain without a USDA permit from the recipient. Failure to identify a  shiga ‐toxin producing strain can violate Commerce Control Regulations for deemed  export, that is immigration status of the lab. workers and export only after obtaining an export permit.  1C351.c.19. Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups; Note: Shiga toxin producing Escherichia coli (STEC) includes, inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) Commerce Control List Supplement No. 1 to Part 774 Category 1—page 69 Export Administration Regulations Bureau of Industry and Security August 30, 2018

Bacterial Verification

What do I need to verify? Just the species or the species and the strain?  Or just the strain?

What about verification of purity? Purity of the species‐only one species present in the culture? 

Purity of the strain‐only one strain present in the culture?  How would this be determined?