Antibiotics/hormones and radiological in hazard analysis
Hello
Question - we sell dried fruits and nuts and pack them in wooden trays, tubs, etc. and use a shelf stable pre-packaged salami and shelf stable pre-packaged cheese in one of the trays that we buy from two companies. The auditor did non-conformance us for not having considered the use of antibiotics or hormones for those two products. He also noted that we did not have a column for radiological hazards. No auditor has ever noticed these before. Not sure how to approach these findings. Any help would be appreciated.
Thank you
Gina
I would reach out to these 2 suppliers and ask if they have any information that can be shared regarding the hormones and antibiotics, their levels, testing, etc.. Get a supplier assurance on this one.
For radiological hazards I lump this into the chemical column of the Hazard Analysis. If you have verbiage more specifically in the material source/approved supplier portion of the HA then you are documenting the origin of the material and if the origin has any impact on radiological hazards that are known in that area which you should have some geographical data on.
The radiological got a couple of my plants a finding, and I believe it has to do with some of the FSMA updates. FDA has some decent explanations of where it might be expected and why we should count it in our HACCPs (everything from radiation coming from a growing area, contaminated water used in processes, even radiation-based sterilization should be evaluated).
Hazard Analysis and Risk-Based Preventive Controls for Human Food - Chapter 3
Auditors are sometimes expecting to see radiation get its own column, however I think it's just fine to list it as one of the potential hazards in your chemical step (since FDA does themselves), and just whether it is a relevant hazard to your ingredients.
I wouldn't expect a hormone or antibiotic to be a hazard to nuts, but it is worth spelling out in the chemical hazards for your meat based ingredients. Statements from your manufacturer would be relevant here to address, the hazard can be controlled with your supplier approval program.
I've always had somewhere in an SOP any radiological risks will be assessed as part of chemical hazards and that always covered us.