News and Stories

FOOD SAFETY UPDATE: FSMA Final Rule for Preventive Controls for Human Food

September 11, 2015


The U.S. Food and Drug Administration (FDA) has announced that the FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food and Preventive Controls for Animal Food have been made final. These two rules focus on implementing modern food manufacturing processes for both human and animal foods and will ensure that food companies take a proactive approach to preventing hazards rather than waiting until after an outbreak has occurred.


Once the seven FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health. Currently, Markon’s food safety program meets and in some cases exceeds FSMA rules. Summarized below are the key requirements of the Preventive Controls for Human Food.


  • All covered facilities producing human or animal food must establish and implement a food safety program that includes a written food safety plan. The requirements for a written food safety plan must include:
    • Hazard analysis: Emphasis to identify potential hazards whether they be biological, chemical, and/or physical
    • Preventive controls: Facilities will be required to have adequate preventive controls in place for the identified hazards throughout their process (includes food allergens, sanitation, water monitoring, etc.) and that there is an effective recall plan in place
    • Oversight and management of preventive controls: The food safety program shall include appropriate documentation to ensure that preventive controls are consistently performed, monitored, and recorded
    • Corrective actions: The food safety program will need to include corrective actions, to identify or correct a problem that may arise during production or processing
    • Verification: Ensuring that preventive controls are effective and being implemented correctly, an example of verification is ATP testing after sanitation to ensure that sanitation was effective and the surfaces are clean.
  • Current Good Manufacturing Practices (GMPs) are updated and clarified
    • Management is required to ensure that any employee that handles food is qualified to perform their assigned duty
    • The employee must have the proper education, training, and/or experience needed to handle food safely
    • Employees are now required to receive training in proper hygiene and food safety (previously only a recommendation)


Attached for your review is the FDA press release and additional information on key requirements.


Markon will continue to update members as more information becomes available.


Lianna Kelly

Food Safety Director


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