Given this adulteration decision, a prudent establishment producing such products should conduct a reassessment of its HACCP plan on or before March 5 to address pSTEC and document such reassessment.
As an initial matter, there is nothing in the FSIS decision that mandates testing for the pSTECs or any other specific control measure. That said, an establishment might consider handling pSTECs the way it handles E. coli O157:H7:
- If an establishment determines E. coli O157:H7 is not a food-safety hazard reasonably likely to occur based on the use of an intervention, FSIS has publicly stated that, based on current data, interventions effective on E. coli O157:H7 will be deemed effective on pSTEC. The hazard analysis should be updated to address pSTEC.
- If an establishment determines E. coli O157:H7 is not a food-safety hazard reasonably likely to occur based on a prerequisite program, such as purchase specifications, the establishment should modify the program to address pSTEC.
A purchase specification prerequisite program can support the decision that pSTEC are not a food-safety hazard reasonably likely to occur, provided:
- The letter of guarantee, that the supplier has a validated intervention, needs to expressly reference pSTECs;
- The COAs represent pSTECs analyses; and
- There are ongoing verification activities, such as supplier “quarterly check samples,” and periodic audits.
At present, it is not known whether there will be sufficient quantities of pSTEC-tested product available for purchase beginning March 5th. In the event that there is not, an establishment could note it will use the E. coli O157:H7 test results to verify the effectiveness of the interventions for both E. coli O157:H7 and pSTEC, at least until pSTEC tested product is available.
The pSTEC adulteration decision is upon us. An establishment needs to have its gameplan prepared so it can implement on or before March 5th.