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Preventive Controls for Human Food

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21 CFR Part 117

The Preventive Controls for Human Food Rule, 21 CFR 117, one of the 7 foundational rules of FSMA is the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, commonly shortened to the Preventive Controls for Human Food (PCHF) rule. The final rule was published in September, 2015 and focused on the following changes:

  1. Implementation of a food safety system based on hazard analysis and risk-based preventive controls. This implementation requires a written food safety plan that addresses identified hazards and how the hazards will be controlled through proper implementation of preventive controls.
  2. Updating the definition of a farm. The PCHF rule provided the definition and clarification for two types of farm operations: primary and secondary activities farms.
  3. Clarification of the supply-chain program. The PCHF rule provided clarification and flexibility to those facilities who rely on suppliers to control hazards.
  4. Updating and clarifying current good manufacturing practices (cGMPs). cGMPs were updated to get rid of any non-binding provisions to make compliance more clear. The update to cGMPs also included binding training requirements for each employee to ensure they are qualified for the duties performed.

FDA Guidance:

Draft Guidance for Industry:  Hazard Analysis and Risk-Based Preventive Controls for Human Food