The final rules entitled “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” mean that companies must implement plans to prevent food under their control from intentional adulteration by performing vulnerability assessments, establishing mitigation strategies and procedures for monitoring, correcting, and verifying a food defense plan. These rules were finalized in September 2016 meaning that companies have between 3 and 5 years for full compliance.
Implementation of food defense plans will most likely require capital asset planning.
The rules are applicable to all foreign and domestic companies required to be registered with the FDA except farms, very small businesses, animal foods, alcoholic beverages, and operations where the container that directly contacts the food remains intact (unopened).
The newly finalized FDA FSMA rules will require that all registered food supply entities follow all applicable FSMA rules. All proposed rules are now law and provide the FDA with full enforcement powers. All companies are open to new FDA and Department of Justice (DOJ) enforcement activities if there is evidence that the food operation does not comply with FSMA rules. The FDA fully intends to prosecute in the event of illness or death caused to humans.
Under the final FSMA rules, a food company executive, manager, or employee can now be charged with a crime even if they did not know they were selling a product that was contaminated or making people sick. Your customers will not allow your company to establish valid preventive controls through analysis of data and causes or your company is open to new FDA and Department of Justice (DOJ) enforcement activities.
The FDA and the DOJ are currently working together to diligently drive the implementation of these new legal food safety requirements through the prosecution of company personnel who do not comply with preventive control rules. Their current prosecution efforts are focused on companies not in compliance if the company has caused a recall, illness, or death whether or not the company has intentionally avoided compliance.
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