Hazard Analysis and Risk-Based Preventive Controls
Domain 2 covers 21 CFR 117.130: identifying known or reasonably foreseeable hazards, then evaluating them to decide which require a preventive control. The written hazard analysis is the hinge of the entire plan.
Two steps, not one
- Identify biological, chemical (including radiological), and physical hazards, considering formulation; facility and equipment design; raw materials and ingredients; transport practices; processing procedures; packaging and labeling; sanitation, hygiene, and employee health; storage and distribution; intended and reasonably foreseeable use; and other factors including economically motivated adulteration and weather or season.
- Evaluate each hazard: would a person knowledgeable about food safety establish a preventive control, based on severity of the illness or injury and probability of occurrence?
117.3 names that outcome a hazard requiring a preventive control. The rule deliberately avoids "reasonably likely to occur" as the trigger, so quoting that older HACCP phrase as the test is a mark-loser.
What must be in place
- A written hazard analysis that both identifies hazards and states which need controls.
- Explicit attention to environmental pathogens for ready-to-eat foods exposed to the environment after a kill step.
- Consideration of hazards that another entity in the supply chain must control (the bridge to Domain 5).
- Reanalysis when a significant change creates a new hazard or a significant increase in an existing one, when a control is found ineffective, and within 90 calendar days of such a trigger.
Worked example
A bakery makes a ready-to-eat cream-filled pastry. Mold on the surface is spoilage, not a hazard requiring a preventive control, if the food is not injurious. Listeria introduced on the filling nozzle after baking is a hazard requiring a control: severity is high (invasive listeriosis) and occurrence is plausible on a moist exposed surface, so a sanitation control with cleaning verification and environmental monitoring is written in. Egg wash carries an undeclared-egg risk if formulations change, so an allergen control covers label and changeover verification. One product, three different answers, each justified by severity and occurrence.
Traps
- Listing every conceivable hazard with no evaluation of significance.
- Omitting environmental pathogens because "we cook it later" - for RTE food the exposure is after the kill step.
- Skipping reanalysis after a new line, new ingredient, or repeated deviation.
- Confusing hazard analysis with verification records or with the monitoring log.