During the fourth video of Kellerman Consulting’s Allergen series, we will be reviewing allergens in the hazard analysis as part of preventive controls-based food safety plans as well as allergens in HACCP plans.
Regulatory agencies that require a food safety plan will expect to see allergens included as hazards to be controlled in those food safety plans, and a documentation of the allergen controls in place addressing those hazards.
As we look at programs requiring Hazard Analysis and Critical Control Points or HACCP Plans, allergen controls may be treated as a prerequisite program or as part of the food safety plan.
Allergens are considered a chemical hazard and should be included in the hazard analysis for each ingredient containing allergens, and for each process step where allergens are handled .
If the allergen is controlled without monitoring at a step, the justification should detail why the allergen is controlled without monitoring. Where allergens are monitored at a step, such as review of allergen scheduling and label reviews, those actions should be included in the hazard analysis as a description of the control.
We have monitoring logs in place at places where risks are higher, so every step where monitoring occurs should have an elevated risk level for severity and likelihood of occurrence in the hazard analysis. Any monitoring log developed to monitor a critical control point that would be a log intended to control an allergen hazard could lead to human or animal harm if not performed correctly each time.
For allergen controls, label inspections or allergen testing are the most commonly identified critical control points for controlling allergens in a food production facility.
For preventive controls plans, allergens are required to be assessed as a chemical hazard. This is equivalent to HACCP Plan expectations.
However, a key difference between HACCP based food safety systems and Preventive Controls Based Food Safety Systems is the concept of Allergen Preventive Controls.
Allergen preventive controls are required under 21 CFR 117.135, and every facility operating under preventive controls expectations must plan for allergen preventive controls where allergens are present in the facility.
It is the recommendation of Kellerman Consulting that each allergen monitoring form in operations be designated as an allergen preventive control on the flow chart, in the hazard analysis and with a preventive controls plan that includes the person responsible, the frequency, the records and the corrective actions for those logs.
Kellerman Consulting further recommends label review and schedule build as basic allergen preventive controls, with additional controls added where required in specific programs, such as special line change over or cleaning techniques performed specifically to control allergens.
For facilities that have HACCP requirements but also have allergen preventive controls requirements, you may elect to keep allergen preventive controls separate from your HACCP plan. This can be confusing, even for long time food safety specialists, so please consider seeking guidance from a regulator or consultant if there is confusion between HACCP plans and allergen preventive controls for seafood and juice facilities.
Lastly, review of your food safety program, including the allergen controls, must be performed each time the plans change, and at least every year, so make sure the food safety team schedules and performs these reviews regularly.
In our final episode, we are going to discuss GFSI requirements for allergens controls in high level safety and quality programs.
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