FSMA Final Rule on Intentional Adulteration: Compliance and Mitigation Strategies

Product Id : FDA301
Instructor : Dr. John Ryan
Apr 16, 2020 12:00 PM ET | 11:00 PM CT | 09:00 AM PT | 60 Minutes


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 defence plan. These rules were finalized in September 2016 meaning that companies have between 3 and 5 years for full compliance. Implementation of food defence 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 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 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.

Join this session by expert speaker John Ryan, where he will discuss about Food Safety Modernization Act. 

Session Highlights :

  • The Final Rules on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
  • Exemptions and Compliance Dates
  • Assessing company needs (vulnerability)Mitigation strategies
  • Plan Basics and Review vulnerabilities
  • Preventive Concepts
  • Verifying and validating food defence plan implementation
  • Test and correction with documentation of whole process.
  • How to protect your company from Lawsuits.

Who Should Attend :

  • Food quality and safety personnel
  • Managers and supervisors in food operations
  • Sanitation specialists and personnel
  • Food packing, processing, distribution, and handling personnel
  • Food ingredient suppliers
  • Legal team members focused on food safety
  • Food facility personnel
  • Food importers
  • Recall specialists
  • Food Safety internal and external auditors
  • Shipper Supervisor and Managers
  • Distribution centre operations personnel
  • Food transportation management
  • Food Buyers and Supply Chain Qualifiers
Speaker Profile:

The speaker, Dr. John Ryan, has a Ph.D. in research and statistical methods. He recently retired from the Hawaii State Department of Agriculture's Quality Assurance Division, where he served as administrator. He has also worked at Cal Poly in San Luis Obispo (California), as a graduate quality and operations management lecturer.

In the last 25 years, he has implemented high-tech quality-control systems for international corporations in numerous countries, including Mexico, United States, and countries in Asia.

He has won numerous awards for his commendable work in the field of traceability technology.

Currently, he is the president of Ryan Systems, and The Sanitary Cold Chain. He is the author of books such as Guide to Food Safety during Transportation: Controls, Standards and Practices, and Food Fraud.

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