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When looking at FSMA, it’s important to look at what we should be doing in industry under FSMA’s prevention scheme. FDA seeks for companies to assess risk and implement preventive controls on a broad basis. Thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or an importer, is key for any food company when planning for the future.
From Reactive to Proactive
With the FSMA rules, FDA has moved from reactive to proactive. Preventive strategies are the essence of FSMA. Proactively creating or updating a food defense and safety plan is the first step to ensure compliance.
The four “A’s” of food defense, as outlined below, provide a methodology for building a proactive and comprehensive food defense program.
Step 1: Assess
Assess the risks throughout the supply chain, including to the origin of raw materials. Conduct a vulnerability assessment of weaknesses and critical control points to identify where someone could attempt product adulteration. The focus must be both inside and outside of company walls and extend to the source of materials and services within the supply chain for producers and distributors of food to the public.
Step 2: Access
Who has access to critical control points and food material risk areas? Pay close attention to the four key activity types that FDA has identified as particularly vulnerable to adulteration:
- Mixing and grinding activities that involve a high volume of food with a high potential for uniform mixing of a contaminant
- Ingredient handling with open access to the product stream
- Bulk liquid receiving and loading
- Liquid storage and handling, which is typically located in remote, isolated areas
Restrict access to these areas from suppliers, contractors, visitors, and most employees—limiting access to critical employees only. This provides a higher level of protection, and supports video and/or physical monitoring.
Step 3: Alerts
Alerts of intentional and unintentional food adulteration must be sent to the appropriate individuals, according to the documented food safety and defense program. Response time is critical. Every passing minute is a minute when more health risks could develop, leading to a greater chance of negative impacts on public safety and the related businesses.
Step 4: Audit
Auditing operational and regulatory compliance helps to ensure and maintain best food defense practices and provide documentation of compliance to regulators. FSMA promotes the safety of the U.S. food supply by focusing on prevention, rather than reactive response. Prevention is only as effective as the actual compliance processes put in place. Regular and random auditing, including remote video monitoring, provides evidence confirming that the appropriate preventive measures are taken and effective.
Taking a proactive approach to food defense that follows these four “A’s” will help meet a key requirement by ensuring that the organization is working to avoid the risks associated with food adulteration and contamination.