The FDA Food Safety Modernization Act (FSMA) has been dubbed the most sweeping reform of the US food law in more than 70 years. It was signed into law by President Obama on January 4, 2011. With public health its core mandate, the law intends to make the US domestic food supply and food imported into the United States safe through the implementation of preventive controls.
On September 17, 2015, the US FDA published final regulations on Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-based Preventive Controls for Human Food. The US food safety regulations are more encompassing than the internationally recognized HACCP standard in that it looks at radiological hazards and food safety hazards associated with fraud and bio-security. The new US FDA regulations also go beyond HACCP by categorizing preventive controls based on the 4 following types: process controls, food allergen controls, sanitation controls and supply-chain controls.
The new US FDA regulations require that specific activities be conducted by a “Preventive Controls Qualified Individual” or PCQI, a person who has experience in implementing risk-based preventive controls plans. The PCQI has the mandate to develop or oversee the preparation of the food safety plan, validates the preventive controls, reviews records and is responsible for re-assessing the food safety plan a minimum of every 3 years unless changes are required. The PCQI may be but is not required to be an employee of the facility.
One way to become a PCQI is to attend an FSPCA course taught by an FSPCA lead instructor. The course developed by the Food Safety Preventive Controls Alliance (FSPCA) is recognized by the US FDA as meeting the requirements of the new food safety regulations.