The seventh and final major rule mandated by the Food Safety Modernization Act (FSMA) was recently published paving the way for the full implementation of the law. The final rule for mitigation strategies to prevent the intentional adulteration of food, also known as ‘food defense’, imposes new requirements for foreign and domestic food facilities. Following are eight points to know about the ‘food defense’ final rule and a few notes regarding the related issue of economically motivated adulteration.

1). Under the final rule, each covered facility would be required to prepare and implement a written food defense plan addressing vulnerabilities and actionable process steps, mitigation strategies, monitoring procedures, corrective actions, and verification activities.

2). A vulnerability assessment must be conducted for each facility. Both foreign and domestic facilities are required to review their production system to identify activities vulnerable to intentional adulteration.

The new rule represents a shift in focus from previous FSMA rules. While previous rules focused on specific foods or hazards, the food defense rule is focused on strategies to reduce risks for vulnerable processes. FDA indicated the most vulnerable activities for intentional adulteration would include:

  • bulk liquid receiving and loading;
  • liquid storage and handling;
  • secondary ingredient handling; and
  • mixing and similar activities

3). Facilities must identify and implement mitigation strategies for each actionable process step. To ensure the proper implementation of each mitigation strategy, facilities should conduct activities such as monitoring, corrective actions and verification.

4). The rule mandates “appropriate training” and recordkeeping. According to the FDA, individuals responsible for developing the food defense plan can be qualified through training, experience or combination thereof. FDA suggested areas for training include food defense awareness, preparing a food defense plan, and conducting vulnerability assessments. Records must be maintained for food defense monitoring, corrective actions and verification activities.

5). The compliance date of the final rule has been extended from the proposed rule. Since the rule introduces several new concepts, the agency is allowing up to three years for companies – other than small or very small businesses – to comply. Small businesses and very small businesses must comply within four and five years, respectively.

6). Who is covered by the rule? Although the FDA has proposed various exemptions, the rule would apply to the majority of domestic and foreign FDA-registered facilities that manufacture, process, or pack food. The rule provides exemptions for farms and various “qualified” facilities, including very small businesses and facilities that hold food other than food in liquid storage tanks, alcoholic beverages, animal food and certain packaging operations.

7). Will FDA accept international standards and existing vulnerability assessments? Unlike the proposed rule, the final rule permits firms to utilize existing records, including international compliance records. The final rule has new requirements for vulnerability assessments, however so companies are advised to review the final rule to ensure their existing vulnerability assessments comply with the rule.

8). While economically motivated adulteration (EMA) is a type of intentional adulteration, the final rule is focused on intentional acts of contamination that would result in large-scale public harm (e.g. terrorism). According to FDA, the monitoring, corrective action, verification and recordkeeping activities mandated by the preventive controls rule are more appropriate for addressing economically motivated adulteration.

EMA, commonly referred to as ‘food fraud’, erodes consumer confidence in the food supply, but the food industry lacks a comprehensive solution to this global problem. Addressing the pervasive threat of EMA to food manufacturers, the Grocery Manufacturers Association (GMA) partnered with Battelle to develop a new software tool that enables users to rapidly analyze quantitative EMA vulnerability data that can be refined by drivers such as geographic stability, supplier reliability, and regulatory environment. EMAlert is a tool for predictive modeling of potential risks based on various data sources, including commodity data, FDA import alerts, food recalls and the USP food fraud database.

Intentional adulteration in the food supply chain, regardless of the motivation, can have a tremendous impact on the industry and consumers alike. Both foreign and domestic food facilities must be keenly aware of all potential adulteration threats and successfully mitigate such issues in order to maintain consumer confidence.

The proposed rule for intentional adulteration provoked more than 200 public comments. The FDA will hold a webinar on June 21 to discuss the seventh and final FSMA rule with industry stakeholders.

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