In 2015, the FDA published their FSMA final rule for Preventive Controls for Human Food. The new rule states, “covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.”
Said food safety system must include a written food safety plan. Food manufacturers covered by the rule that previously utilized the Hazard Analysis Critical Control Point (HACCP) guidelines to establish their food safety system will need to take additional steps to adhere with the FSMA compliant Hazard Analysis and Risk-Based Preventive Controls (HARPC). The main difference between the two comes in the added HARPC requirement to evaluate potential hazards and implement measures to prevent them.