The FDA Food Safety Modernization Act Preventive Controls for Human Food identifies four types of preventive controls. The first two types of preventive controls, Process Preventive Controls and  Food Allergen Preventive Controls were discussed in my October and November, 2016 columns respectively.

The Preventive Controls for Human Food regulation also requires documented Sanitation Preventive Controls. The need for specific sanitation preventive controls is determined through the hazard analysis.

The Hazard Analysis identifies hazards requiring a preventive control such as:

  • Environmental pathogens when RTE food is exposed to the environment prior to packaging

Listeria monocytogenes and Salmonella are major hazards for food safety in RTE food products which are exposed to the processing environment prior to packaging. It is critical to minimize or prevent these hazards.

  • Pathogens transferred through cross-contamination

Cross-contamination is the unintentional transfer of a pathogen from an insanitary object or employee to a food. Clean equipment and good employee hygiene practices are essential to control cross-contamination.

  • Food Allergen Cross-Contact

Allergen cross-contact is the unintentional incorporation of a food allergen into a food. Good employee hygiene and clean equipment are required to prevent allergen cross-contact.

GMPs and other prerequisite programs work together to establish a sound foundation for sanitation preventive controls. Plant design must prevent contamination of stored raw materials, ingredients, food, and food contact surfaces. Use of hygienic zoning may be useful because control of traffic patterns between areas with different levels of hygiene can minimize the transfer of hazards.

 Sanitation Preventive Controls must describe:

  • Monitoring activities and frequency
  • Corrections to be made when requirements are not met. Corrections are when you take action in a timely manner to identify and correct a minor and isolated problem that does not directly impact product safety, such as identifying a food-contact surface that was not properly cleaned and re-cleaning it prior to production.
  • Corrective actions that apply for pathogens and allergens. Corrective actions are procedures that must be taken if preventive controls are not properly implemented, and involve documentation of the specific actions taken.
  • Verification activities

In my January, 2017 column the fourth type of preventive controls; Supply Chain Preventive Controls will be addressed

For additional information on FDA’s Sanitation Preventive Controls go to the Food Safety Preventive Controls Alliance (FSPCA) website,