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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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Color-Coding as a Preventative Strategy 21 CFR 117 Subpart B: Current Good Manufacturing Practice §117.10 Personnel §117.20 Plant and grounds §117.35 Sanitary operations §117.37 Sanitary facilities and controls §117.40 Equipment and utensils §117.80 Processes and controls §117.93 Warehousing and distribution §117.95 Holding and distribution of human food by-products for animal food §117.110 Defect action levels 21 CFR 117 Subpart C: Hazard Analysis and Risk-based Preventive Controls §117.135 (c) on Preventive Controls: (1) Process controls (2) Food allergen controls (3) Sanitation controls (4) Supply chain controls (5) Recall plan 21 CFR 117 Subpart C: Hazard Analysis and Risk-based Preventive Controls §117.135 (c) : (6) Other controls i.e. procedures, practices and processes that qualify as Preventive Controls Standard Operating Procedures (SOPs) Food Safety Plan Color Coding as a Best Practice There are three main ways a color-coding plan can fit into a food safety management system: 1. As part of the Standard Operating Procedures: A color-coding plan can specify the colors used for scoops for handling different products within an allergen SOP, or cleaning brushes to be used for different surfaces within a Sanitation Standard Operating Procedure (SSOP). 2. As a Preventive Control within a Food Safety Plan: For this, the plan must be validated or justified, monitored, verified, and reviewed as a food safety control. 3. As a Standalone Color-Coding Plan: This could reference other procedures and can also follow the same format as the food safety plan. The facility may decide to reference color-coding within their Current Good Manufacturing Practices (CGMPs), Preventive Controls, or Best Practices framework as long as there’s consistency and a clear process of justifying, verifying, and reviewing the program. Developing a Color-Coding Plan The steps to establishing any preventive controls are as follows: 1. Conduct a Comprehensive Hazard Analysis: Do you have areas where there’s a chance of allergen cross-contact or cross-contamination? These could be the right place to establish color-coding zones or use color-coded implements. 2. Evaluate the Applicability of Color-Coding: Will color-coding prevent issues? If you need to keep scoops separated because they’re not easily identifiable, it would be an appropriate use of color-coding as a preventive control. If raw product is touching finished product because there isn’t enough workspace, color-coding may not help. A. Conduct a Comprehensive Hazard Analysis B. Evaluate the Applicability of Color-Coding C. Establish Control Measures, Preven ti ve Controls and Pr actices D. Set the Monitoring, Corre cti v e Action, Ve rifi ca tion, and Review Criteria for the Plan E. Educate, Train, and Refresh the Employees on the Plan 3. Establish Control Measures, Preventive Controls, and Practices: Color-coding may be employed as part of the current Good Manufacturing Practices, or as a risk-based Preventive Control, or as an industry best practice. 3
