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  5. FSMA Final Rule for Preventive Controls for Human Food
  1. Food Safety Modernization Act (FSMA)

FSMA Final Rule for Preventive Controls for Human Food

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic Act must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies).  It is important to note that applicability of the CGMPs is not dependent upon whether a facility is required to register.

This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.

Compliance dates are staggered, based on the size of the business, with separate dates for the requirements of the supply chain program. Training, education, and technical assistance are available for those covered by this rule.

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