INTRODUCTION According to the CDC, 1 in 6 Americans become sick by eating contaminated food every year, resulting in an estimated 3,000 deaths. As if the human cost isn’t sobering enough, the Grocery Manufacturers Association also estimates the average cost of a recall to a food company is $10 million in direct costs in addition to brand damage and lost sales. Considering growing public health concerns and the economic burden of foodborne illnesses, the 2011 Food Safety Modernization Act shifted the FDA’s focus from simply responding to food safety problems to trying to prevent them. FSMA now requires food facilities to conduct a comprehensive hazard analysis and then establish risk-based preventive controls. For a number of facilities, color-coding has become one of the preventive controls to protect food against direct contamination, cross-contact, and cross-contamination incidences. Defining Preventive Controls According to 21 CFR 117 Subpart C, preventive controls are risk- based assurances that relevant food safety hazards are significantly minimized or prevented upon application of that control. The same regulations also stipulate that food manufactured, packed, or held by a facility will not be adulterated or misbranded in any way. As illustrated in the diagram to the right, Preventive Controls are distinguished from the modified Current Good Manufacturing Practices (or CGMPs, which are the minimum, legally required sanitary and processing practices describing the methods, equipment, facilities, and controls for producing safe and wholesome food). Color-coding as an industry best practice can definitely qualify as a valid preventive control. 21 CFR 117 Subpart B: Current Good Manufacturing Practices 21 CFR 117 Subpart C: Hazard Analysis and Risk-Based Preventive Controls Other procedures, practices, or processes necessary to satisfy the requirements for a Preventive Control Color-Coding as a Best Practice Benefits of Color-Coding as a Preventive Control Color-coding quickly communicates essential information for food safety, regardless of language barriers. It’s this simplicity that makes color-coding an effective preventive control. Colors can signal the process status – visualize the traffic lights and what each color communicates to a driver. The same concept could apply to material handling across process flows and act as a signal for whether the product should move to the next process level or not. Cooked Raw Signal or Communicate the Process States Color Coding Functions Wheat Soy More importantly, colors act as visual cues to identify the personnel, equipment or tools within an area. If blue-bristled pipe brushes are used for cleaning food conveyance pipes, and black-bristled tube brushes are used for clearing drains, there is a clear identifier between food-contact and non-food contact tools to prevent accidental misuse. Promote process ownership and food safety culture Separate zones and products based on risk Wheat Flour Soy Lecithin Identify personnel, equipment, or tools The other function of color-coding is that colors can separate zones and products based on risk. Something as simple as red and blue storage tubs could easily separate low-risk raw meat from high-risk processed product to prevent cross-contamination. It can also be used to separate allergen zones. 2
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