All food producers (domestic producers and international exporting organizations) (i.e., food manufacturers, processors, packers, and distributors), except USDA regulated meat, poultry, and processed egg producers, are required to comply with general FSMA requirements unless otherwise exempted.
On January 4, 2011, the Food Safety Modernization Act (FSMA), the first major reform of the US Food and Drug Administration (FDA) in over 70 years, was signed into law. This sweeping and historic act is intended to shift FDA focus to better protect public health by preventing food safety issues rather than reacting to outbreaks. The FDA Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
The FSMA Preventive Controls rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule” is one of the seven rules that is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires domestic and international food facilities (i.e., food manufacturers, processors, packers and distributors) that are registered with the FDA to develop and implement a Food Safety Plan that complies with the requirements and that certain activities must be completed by a “Preventive Controls Qualified Individual” (PCQI)
The FSMA Preventive Controls rule requires that certain activities must be completed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls.