Food Safety Hazards and Preventive Controls Overview
Domain 1 asks you to classify hazards and explain how the risk-based preventive controls of 21 CFR Part 117 build on HACCP. Expect scenarios showing a process, with questions on the hazard type present and the control category that should manage it.
The hazard categories the rule covers
- Biological - Salmonella, Shiga toxin-producing E. coli, Listeria monocytogenes, Clostridium botulinum, Staphylococcus aureus toxin, Bacillus cereus, parasites, viruses.
- Chemical - cleaning compounds, pesticides, mycotoxins, drug residues, unapproved color additives, and food allergens. The major allergen list is nine: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (sesame added by the FASTER Act, effective 1 January 2023). Undeclared allergens are the leading cause of U.S. food recalls.
- Physical - glass, metal, hard plastic, stones, wood, bone.
- Radiological - grouped with chemical hazards in the rule.
What a food safety plan must contain
Subpart C requires a written plan prepared, or overseen, by a Preventive Controls Qualified Individual (PCQI). Preventive controls fall into process, food allergen, sanitation, supply-chain, and "other" (including a recall plan). The cGMPs of Subpart B are baseline facility-wide conditions, not preventive controls - a distinction the exam uses repeatedly.
Worked example
A facility makes chilled ready-to-eat chicken salad, packed after cooking. L. monocytogenes can be reintroduced from the environment after the cook step, so sanitation controls plus environmental monitoring apply. Milk powder in the dressing can cross-contact the plain batch, so an allergen control (dedicated utensils, verified changeover, label check) applies. Metal fragments are plausible from the dicer, so metal detection is a process control. Salmonella in the raw chicken is eliminated by the validated cook, which is itself the process control. Four hazards, four different control categories - the reasoning earns the marks, not the label.
Traps that cost marks
- Assuming every identified hazard needs a preventive control; only hazards requiring one do.
- Treating allergen control as a labeling or quality issue rather than a hazard control.
- Forgetting sanitation controls include preventing allergen cross-contact.
- Confusing cGMPs, applied facility-wide, with point-specific preventive controls.