On September 10, 2015, the US Food and Drug Administration (US FDA) published the Final Rule for Preventive Controls for Human Food as part of the implementation of the Food Safety Modernization Act (FSMA). The act was signed into law by President Obama on January 4, 2011. Regulations (“rules”) under FSMA are intended to prevent food safety risks and ensure a safe food supply. While FDA has extended compliance deadlines, most businesses within the scope of the preventive control rule must comply by September 2018.
The rule applies to foreign and domestic “facilities” that “manufacture, process, pack, or hold food for consumption in the United States.” Facilities are required to register with the US FDA and must develop and implement a food safety management system that includes a hazard analysis and risk-based preventive controls. Documentation takes the form of a written food safety plan in which bacterial, chemical, physical and, if applicable, radiological hazards are identified (food security risks to be considered). The plan also includes operating procedures which are developed for the preventative control of identified food safety hazards. These procedures that form part of the food safety management system cover the ongoing monitoring, corrective action, verification and validation of preventative controls and are regularly reviewed by management for effectiveness.
Primary and secondary producers (i.e; “farms”) conducting activities on produce are exempt from the regulatory requirements and will be covered by the Produce Safety Rule which has yet to be finalised. Food facilities, where applicable, must also develop and implement supply chain controls. This requirement pertains to risks associated with raw material and other ingredients. This requirement is waived for facilities which have implemented preventive controls or who rely on a customer to control supply chain risks.
Current Good Manufacturing Practices (cGMP) – new mandatory requirements.
Food safety plans, now called HARPC plans for “Hazard Analysis and Risk-based Preventive Controls” will be supported by revised Current Good Manufacturing Practices (cGMP). The cGMP for food processing have been modernised to take into account current food safety risks and technological advances (2). The revised text for cGMP is the result of a review by food safety experts. “Deficient employee training,” “contamination of raw materials,” “poor plant and equipment sanitation,” and “poor plant design and construction” have been identified as top food safety concerns in food processing environments. Results from the review also indicate that refrigerated and dairy foods have the “highest general risk of food safety problems” compared to other food categories. Baked and refrigerated foods also present the highest risks for allergen hazards. Contrary to perceptions, the study also reports that small and medium-sized food processors generate “higher risk scores” compared to large food facilities, across all food safety issues and food categories studied.
The revised cGMP now include binding requirements and the documentation of employee training is now mandatory: “employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene. “The new regulatory text also addresses similar training requirements for employees involved in the monitoring of preventive controls.” In addition, food safety risks associated with allergen cross-contact are now explicitly addressed in the cGMP.