HACCP Regulatory Standards & Compliance 2 — Questions and Answers
Question 1: Which FDA regulation mandates HACCP implementation for seafood processors in the United States?
- 21 CFR Part 123 (Correct answer)
- 21 CFR Part 110
- 21 CFR Part 117
- 21 CFR Part 120
Correct answer: 21 CFR Part 123
21 CFR Part 123 (Fish and Fishery Products) requires seafood processors to develop and implement HACCP plans.
Question 2: Under USDA FSIS regulations, what must a meat processing facility do when a critical limit is exceeded at a CCP?
- Continue production while investigating
- Immediately implement the corrective action procedure (Correct answer)
- Notify FDA within 24 hours
- Shut down the entire facility
Correct answer: Immediately implement the corrective action procedure
FSIS requires that when a critical limit deviation occurs, the facility must immediately implement predefined corrective actions to control the affected product.
Question 3: The FDA Food Safety Modernization Act (FSMA) introduced which preventive controls rule that incorporates HACCP-like principles?
- PCHF Rule (Correct answer)
- SFSP Rule
- FSVP Rule
- FSMA Part 11
Correct answer: PCHF Rule
The Preventive Controls for Human Food (PCHF) rule under FSMA requires food facilities to implement a food safety plan with HACCP-like hazard analysis and preventive controls.
Question 4: Which agency oversees HACCP compliance for juice processors in the United States?
- USDA FSIS
- FDA (Correct answer)
- CDC
- EPA
Correct answer: FDA
The FDA regulates juice processors under 21 CFR Part 120, which mandates HACCP plans for juice products.
Question 5: How long must HACCP records be retained for low-acid canned food (LACF) processors under FDA regulations?
- 6 months
- 1 year
- 3 years (Correct answer)
- 5 years
Correct answer: 3 years
FDA regulations for LACF processors require that HACCP and process records be retained for a minimum of 3 years.
Question 6: Under the USDA FSIS HACCP rule (9 CFR Part 417), what is required when a new biological hazard is identified that was not in the original hazard analysis?
- File an amendment with FSIS
- Reassess the HACCP plan (Correct answer)
- Notify the local health department
- Implement a new CCP within 90 days
Correct answer: Reassess the HACCP plan
9 CFR Part 417 requires establishments to reassess their HACCP plan whenever new hazards emerge or process changes occur.
Question 7: Which international standard provides guidelines for food safety management systems that align with HACCP principles and is widely recognized for global trade compliance?
- ISO 9001
- ISO 22000 (Correct answer)
- ISO 14001
- ISO 45001
Correct answer: ISO 22000
ISO 22000 is the international standard for food safety management systems that incorporates HACCP methodology and is recognized for international trade compliance.
HACCP Regulatory Standards & Compliance 2
Which FDA regulation mandates HACCP implementation for seafood processors in the United States?