The final rules entitled “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” under FDA FSMA, 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. Implementation of food defense plans will most likely require capital asset planning.
These rules were finalized in September 2016 and companies have only between 3 and 5 years for full compliance. 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 now 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.
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).
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. The FDA and the DOJ are currently working together to diligently drive 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. In this session, Dr. John M. Ryan will discuss the FDA’s final food defense rules in detail and help you create an effective food defense plan to ensure compliance with the new rules under FSMA.
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Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Dr. John Ryan holds a Ph.D. in research and statistical methods. He has been working on transportation food safety issues since 2011 after retiring from his position as the administrator for the Hawaii State Department of Agriculture's Quality Assurance Division where he headed up Hawaii’s commodity inspection, food safety certification and measurement standards service groups. He has won awards for traceability technology for his visionary...
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