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.
A Preventive Controls Plan is a dynamic document which must be kept current, and which is overseen and approved by at least one Preventive Controls Qualified Individual (PCQI). The food safety plan is supported by Good Manufacturing Practices (GMP). The plan includes a hazard analysis completed on raw materials, ingredients, processing aids and packaging materials as well on all food manufacturing process steps. The hazard analysis considers food safety hazards that are present in the food because they happen naturally, hazards that may be unintentionally introduced, hazard that may be intentionally introduced for economic gain. Three categories of hazards are studied: Biological, Chemical (including radiological) and Physical. The outcome of the hazard analysis determines the significant hazards that are likely to occur and must be controlled by Preventive Controls. There are 4 types of controls: Process, Sanitation, Allergen and Supply-chain controls.
Sirocco Consulting will help you successfully develop your Preventive Controls food safety plan to meet FSMA requirements. Karine Lawrence is an authorized PCQI /FSPCA Lead Instructor for the Preventive Controls for Human Food.
The compliance deadline is fast approaching as very small businesses will be expected to comply with Preventive Controls by September 17, 2018. Need help with your Preventive Controls Plan? Give us a call.
Note: a very small business averages less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, during the preceding 3-year period.