HACCP Regulatory Standards & Compliance 3 — Questions and Answers
Question 1: Under FSMA's PCHF rule, which type of facility is exempt from the requirement to have a written food safety plan?
- Facilities with fewer than 500 employees
- Very small businesses with under $1 million in annual food sales averaged over 3 years (Correct answer)
- Farms selling directly to consumers
- Facilities producing only raw agricultural commodities
Correct answer: Very small businesses with under $1 million in annual food sales averaged over 3 years
Very small businesses averaging under $1 million in annual food sales over 3 years are exempt from the full written food safety plan requirement under PCHF.
Question 2: The Codex Alimentarius Commission's HACCP guidelines are contained in which document?
- CAC/RCP 1-1969 (Correct answer)
- CAC/GL 21-1997
- CAC/RCP 36-1987
- CAC/MISC 6-2005
Correct answer: CAC/RCP 1-1969
The Codex General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 2003) contains the Annex on HACCP and serves as the foundational international reference.
Question 3: A HACCP plan validation study is required under US regulations primarily to confirm which of the following?
- That employees have read the HACCP manual
- That critical limits are scientifically supported and will control the hazard (Correct answer)
- That the facility passed its last inspection
- That monitoring equipment is calibrated annually
Correct answer: That critical limits are scientifically supported and will control the hazard
Validation ensures that the critical limits and overall HACCP system are scientifically sound and effective at controlling identified hazards.
Question 4: Which USDA FSIS directive requires poultry slaughter establishments to meet Salmonella performance standards as part of their HACCP system?
- 9 CFR Part 381
- 9 CFR Part 417 (Correct answer)
- 9 CFR Part 310
- FSIS Directive 10,010.1
Correct answer: 9 CFR Part 417
9 CFR Part 417 sets the overarching HACCP requirements for FSIS-regulated establishments, including meeting pathogen reduction performance standards like those for Salmonella.
Question 5: Under the FDA juice HACCP rule (21 CFR Part 120), processors must achieve what minimum 5-log reduction of the pertinent pathogen?
- In the final product only
- Through the combination of all processing steps (Correct answer)
- At a single designated CCP
- Only when using thermal processing
Correct answer: Through the combination of all processing steps
The juice HACCP rule requires a 5-log reduction of the pertinent pathogen achieved through the overall process, not necessarily at a single step.
Question 6: What does a HACCP-based corrective action record specifically document according to US regulatory requirements?
- Employee training attendance
- The disposition of the affected product and steps taken to prevent recurrence (Correct answer)
- Customer complaint details
- Equipment maintenance schedules
Correct answer: The disposition of the affected product and steps taken to prevent recurrence
Corrective action records must document how the affected product was handled and what was done to prevent the deviation from recurring.
Question 7: Under the SQF (Safe Quality Food) certification standard, which HACCP-related element is required for a facility to achieve SQF Level 2 certification?
- A third-party laboratory audit
- A fully implemented and verified HACCP plan (Correct answer)
- Organic certification of all ingredients
- An FDA facility registration number
Correct answer: A fully implemented and verified HACCP plan
SQF Level 2 requires a fully implemented, verified, and validated HACCP-based food safety plan as its core requirement.
HACCP Regulatory Standards & Compliance 3
Under FSMA's PCHF rule, which type of facility is exempt from the requirement to have a written food safety plan?