HACCP (Hazard Analysis Critical Control Points) General 4 — Questions and Answers
Question 1: A juice manufacturer uses UV light treatment to eliminate pathogens. Under FDA 21 CFR Part 120, what is the required 5-log reduction target organism for juice HACCP?
- Salmonella Typhi
- The pertinent pathogen of most concern for that juice (Correct answer)
- E. coli O157:H7 for all juices
- Listeria monocytogenes for all juices
Correct answer: The pertinent pathogen of most concern for that juice
FDA requires a 5-log reduction of the 'pertinent pathogen' — the most resistant and relevant pathogen associated with the specific juice type.
Question 2: What is the significance of 'flow diagrams' in a HACCP plan?
- They document employee training schedules
- They provide a step-by-step map of the food process used to identify hazards (Correct answer)
- They list supplier contact information
- They outline the facility's emergency response procedures
Correct answer: They provide a step-by-step map of the food process used to identify hazards
Process flow diagrams visually map every step in food production and are essential for identifying where hazards may be introduced, controlled, or increased.
Question 3: Which organization developed the seven HACCP principles that form the international standard?
- FDA and USDA jointly
- Codex Alimentarius Commission (Correct answer)
- National Restaurant Association
- ISO Technical Committee 34
Correct answer: Codex Alimentarius Commission
The Codex Alimentarius Commission, a joint FAO/WHO body, established the internationally recognized seven HACCP principles in its general guidelines (CAC/RCP 1-1969).
Question 4: When a corrective action is taken because a critical limit was not met, what must be done with the affected product?
- It must always be destroyed
- Its safety must be evaluated and disposition determined before release (Correct answer)
- It may be released if the deviation was minor
- It must be retested and released within 24 hours
Correct answer: Its safety must be evaluated and disposition determined before release
Corrective actions require evaluating the affected product to determine whether it is safe for its intended use, with disposition (release, reprocess, or destroy) based on that evaluation.
Question 5: What is 'challenge testing' in the context of HACCP validation?
- Testing employees on their knowledge of HACCP principles
- Inoculating food with pathogens to confirm a process step achieves the required kill (Correct answer)
- Testing equipment calibration against known standards
- Auditing suppliers to verify their HACCP plans
Correct answer: Inoculating food with pathogens to confirm a process step achieves the required kill
Challenge testing (microbial challenge studies) deliberately introduces target pathogens into food to scientifically confirm that a CCP's control measure achieves the required reduction.
Question 6: Under FSMA's Preventive Controls for Human Food rule, what term is used instead of 'Critical Control Point'?
- Key Control Step
- Process Preventive Control (Correct answer)
- Hazard Intervention Point
- Safety Critical Node
Correct answer: Process Preventive Control
FSMA's Preventive Controls rule uses 'process preventive control' for steps such as cooking or pasteurization that require monitoring, corrective actions, and verification — analogous to CCPs in HACCP.
Question 7: A HACCP team is assessing whether high salt concentration in a cured meat product controls Clostridium botulinum. This assessment is an example of which HACCP activity?
- Monitoring
- Hazard analysis (Correct answer)
- Record-keeping
- Corrective action planning
Correct answer: Hazard analysis
Evaluating whether a control measure (salt concentration) is effective against a specific hazard (C. botulinum) is part of the hazard analysis conducted in HACCP Principle 1.
HACCP (Hazard Analysis Critical Control Points) General 4
A juice manufacturer uses UV light treatment to eliminate pathogens.
Under FDA 21 CFR Part 120, what is the required 5-log reduction target organism for juice HACCP?