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FDST-MDS study materials
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FDST-MDS: Food Safety and Regulatory Compliance

FDST-MDS · Work through your exam, one topic at a time.

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Food Safety and Regulatory Compliance

This domain tests whether you can turn food law and preventive-control frameworks into defensible plant decisions: HACCP logic, FSMA preventive controls, cGMPs, allergen control, and recall classification. Expect scenario questions where a record, a label, or a deviation must be judged against a specific rule.

Core rules

  • HACCP has seven principles: hazard analysis, CCP determination, critical limits, monitoring, corrective actions, verification, and recordkeeping. A CCP needs a measurable critical limit such as time and temperature; a control point without a critical limit is not a CCP.
  • Prerequisite programs (GMPs, SSOPs) support the HACCP plan but never replace it. Under 21 CFR 117, preventive controls cover process, allergen, sanitation, supply-chain, and recall elements.
  • The FDA Food Code lists time/temperature control for safety foods in the 41–135°F range. Cooling moves 135°F to 70°F within 2 hours and to 41°F within 6 hours total.
  • Major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame was added by the FASTER Act, effective 2023.
  • Recall classes: Class I is reasonable probability of serious health consequences or death; Class II is temporary or medically reversible; Class III is unlikely to cause harm.

Worked example

A bakery learns that a cookie lot contains undeclared milk. Milk is a major allergen and can trigger anaphylaxis, so the hazard is severe even if only sensitive consumers are affected. The recall is Class I. Traceability records then identify lot codes and distribution depth; if product reached retail, public notice and effectiveness checks follow.

Traps that cost marks

Calling a step a CCP without a measurable critical limit. Confusing validation (scientific evidence that limits control the hazard) with verification (records, calibration, review). Treating may-contain statements as a substitute for allergen control. Assuming the Food Code applies uniformly nationwide; it is model law adopted by states and localities.