HACCP Regulatory Standards & Compliance 4 — Questions and Answers
Question 1: A food manufacturer exports product to the European Union. Which EU regulation establishes HACCP requirements for food business operators?
- EC Regulation 852/2004 (Correct answer)
- EC Regulation 178/2002
- EC Directive 93/43/EEC
- EC Regulation 1169/2011
Correct answer: EC Regulation 852/2004
EC Regulation 852/2004 on the hygiene of foodstuffs requires EU food business operators to implement HACCP-based procedures.
Question 2: When the FDA conducts a HACCP inspection at a seafood facility, which document is the primary record inspectors review to assess program adequacy?
- Employee health policy
- The HACCP plan including hazard analysis, CCPs, critical limits, and monitoring records (Correct answer)
- Supplier qualification records only
- Building and pest control logs
Correct answer: The HACCP plan including hazard analysis, CCPs, critical limits, and monitoring records
FDA inspectors focus on the complete HACCP plan — hazard analysis, CCPs, critical limits, monitoring procedures, and associated records — to evaluate program adequacy.
Question 3: Under 9 CFR Part 417.5, HACCP records for most meat and poultry establishments must be maintained for a minimum of how long?
- 6 months
- 1 year (Correct answer)
- 2 years
- 5 years
Correct answer: 1 year
9 CFR Part 417.5 requires that HACCP records be maintained for at least 1 year for refrigerated products and 2 years for frozen, preserved, or shelf-stable products.
Question 4: A retail deli operation is subject to which type of regulatory HACCP requirement in most US states?
- Federal FDA mandatory HACCP
- State and local food code voluntary guidance based on FDA Food Code (Correct answer)
- USDA FSIS mandatory HACCP
- No HACCP requirements apply to retail
Correct answer: State and local food code voluntary guidance based on FDA Food Code
Most retail food operations follow state and local food codes, which typically reference the FDA Food Code that encourages but does not always mandate formal HACCP.
Question 5: The FSMA Foreign Supplier Verification Program (FSVP) requires US importers to verify that foreign suppliers maintain food safety systems equivalent to what standard?
- Codex HACCP only
- Standards that provide the same level of public health protection as US requirements including preventive controls (Correct answer)
- ISO 22000 certification
- GFSI benchmark scheme certification
Correct answer: Standards that provide the same level of public health protection as US requirements including preventive controls
FSVP requires that foreign suppliers produce food using processes that provide the same level of public health protection as applicable US safety standards.
Question 6: Which GFSI-recognized certification scheme was developed specifically for food manufacturers and is owned by the Consumer Goods Forum?
- BRC Global Standard
- FSSC 22000 (Correct answer)
- IFS Food
- SQF Code
Correct answer: FSSC 22000
FSSC 22000 (Food Safety System Certification) is a GFSI-recognized scheme owned by the Foundation FSSC, based on ISO 22000 with additional requirements, and is widely adopted by food manufacturers.
Question 7: Under FDA regulations, which product category requires HACCP-trained individuals to sign and date the HACCP plan at least once every 12 months?
- Dietary supplements
- Juice and seafood products (Correct answer)
- Bakery products
- All foods regulated by FDA
Correct answer: Juice and seafood products
FDA's HACCP regulations for juice (21 CFR 120) and seafood (21 CFR 123) require that a trained individual reassess and sign/date the HACCP plan at least annually.
A food manufacturer exports product to the European Union.
Which EU regulation establishes HACCP requirements for food business operators?