Which regulation governs Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for human food?

• A. 21 CFR Part 117
• B. 21 CFR Part 507
• C. 9 CFR Part 381
• D. 9 CFR Part 416

Answer: (A)

The regulation that sets the requirements for current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food is 21 CFR Part 117. This rule, established under the FDA’s FSMA framework, requires facilities to follow CGMPs, perform a hazard analysis, implement preventive controls based on risk, and maintain proper records and procedures to prevent contamination. The other regulations address different sectors: Part 507 covers animal food GMPs and HACCP, while Part 381 and Part 416 pertain to meat and poultry production and sanitation under USDA FSIS, not the broader scope of human food. So Part 117 is the correct regulation for human food safety in this context.