Preventive Controls for Human Food: The Basics

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In September of 2015, FDA published the regulation titled Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food, (referred to as the Preventive Controls for Human Food regulation) found in Part 117 in Title 21 of the Code of Federal Regulations. It is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States.

Who must comply? 

In general, all FDA registered food manufacturing/production facilities must comply with at least some portion of this rule.

  • All FDA-registered facilities must comply with Good Manufacturing Practices (cGMPs).
  • Businesses with annual sales >$1 million must comply with all parts of the rule and perform a hazard analysis as part of their food safety plan
  • Qualified Facilities (<$1 million total food sales) are exempt from hazard analysis and preventive controls.

What is required?

    • Training requirements include qualified individuals and Preventive Controls Qualified Individuals (PCQI)
    • Facilities that must comply with all portions of the rule must:
      • conduct a hazard analysis identifying known or reasonably foreseeable biological, chemical, physical hazards
      • identify hazards that require preventive controls (i.e., process, allergen, sanitation, supply-chain, recall)
      • conduct monitoring, corrective actions, and verification activities.
      • maintain records of all preventive control monitoring, corrective actions and verification activities.

When must I comply?

Size/Type of Business Compliance Date
Large businesses (average annual sales >$1 million) September 19, 2016
Small businesses (average annual sales >$1 million and <500 full time employees) September 18, 2017
Business subject to the Pasteurized Milk Ordinance September 17, 2018
Qualified facility (very small businesses with average annual sales <$1 million; exempt from hazard analysis and preventive controls) September 17, 2018 (cGMPs)