The Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years. It was signed into law by President Obama on January 4, 2011. Its goal is to ensure that the U.S. food supply is safe. It shifts the focus from responding to food safety problems to preventing them. The FSMA has many parts. The Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation (hereafter referred to as the Preventive Controls for Human Food) is that part of the FSMA which relates to food manufacturing. It was published on September 15, 2015. Compliance dates for Preventive Controls for Human Food (other than supplier programs) are;

  • September 19, 2016 –  Businesses with more than 500 full-time equivalent employees
  • September 18, 2017 –  Small businesses with less than 500 full-time equivalent employees
  • September 17, 2018 –  Very small businesses with less than 1 million dollars in annual food sales

To comply with the Preventive Controls for Human Food regulation each plant must develop and implement a Food Safety Plan. The Food Safety Plan contains;

  • Background information – optional – Useful information to organize the plan
    • Facility oveview and Food Safety Team
    • Product description
    • Flow diagram
    • Process descriptions
  • Hazard Analysis
    • Identifies known or reasonably foreseeable biological, chemical or physical hazards
    • Drives decision making for the controls that must be included in the Food Safety Plan
  • Process preventive controls
    • Food allergen preventive controls
    • Sanitation preventive controls
    • Supply chain preventive controls
    • Preventive Controls – These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. Preventive Controls are developed in four different areas.

(NOTE: Each of these Preventive Controls will be addressed in columns October 2016-January 2017.)

  • Food Safety Plan Recall Plan
    • Required when a hazard requiring a preventive control is identified
    • Describes what to do when something goes wrong
  • Food Safety Plan Implementation Procedures – Examples of implementation procedures
    • Validation studies
    • Monitoring procedures
    • Corrective actions and corrections procedures
    • Verification activities


The regulation requires that certain tasks be performed (or overseen) by a Preventive Controls Qualified Individual. The responsibilities of a Preventive Controls Qualified Individual include    1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review and 4) reanalysis of the Food Safety Plan. In my opinion, each facility should have one or more Preventive Controls Qualified Individuals on staff.

For a listing of courses teaching Preventive Controls for Human Food go to the Food Safety Preventive Controls Alliance (FSPCA) website home page. Under Training click on the FSPCA Preventive Controls for Human Food. On the FSPCA Preventive Controls for Human Food webpage under Resources click on FSPCA Preventive Controls for Human Food Courses.