Preventive Controls for Human Food (PCQI)

Final rule on Food Safety Modernization Act was published in September of 2015. Compliance dates for this food law were September 2016, 2017 and 2018 based on business size and annual revenue.
Up to 2016 only few food sector categories were regulated for HACCP. USDA regulates meat and poultry industry, FDA regulates seafood and juice industry.
Other food sector categories were not under regulations that would require food safety systems.
Intention of Food Safety Modernization Act was to fill up the gap and require other food sector categories to develop and implement food safety plan.
Food Safety Modernization Act was translated into Code of Federal Regulation and published as 21 CFR 117. Part C of that CFR requires that all businesses that manufacture, hold, process, or store food product conduct hazard analysis and identify Preventive Controls for significant food safety hazards.

The following types of Preventive Controls were identified in 21 CFR 117: Process Preventive Controls, Allergen Preventive Controls, Sanitation Preventive Controls and Supply Chain Preventive Controls.

Additionally, all businesses that identified at least one of the above Preventive Controls must develop and implement Recall Plan.

FSMA also requires that food businesses have Preventive Control Qualified Individual. Person who undergone proper training and is overall responsible for development, implementation and maintenance of Food Safety System.

You can become Preventive Controls Qualified Individual by taking FSPCA PCQI class offered by BD Food Safety Consultants. FSPCA came up with standardized curriculum that is recognized by FDA. For more information, please visit

Food Safety Modernization Act is not to replace current HACCP regulations but work in conjunction with current food safety principles.
Companies that voluntary adopted HACCP will need to decide whether merge their food safety systems into one or keep Preventive Controls separate from HACCP.

This is definitely something Preventive Controls Qualified Individuals will need to look into.