THE FDA FINAL FOOD DEFENSE RULES UNDER THE FOOD SAFETY MODERNIZATION ACT (FSMA)

Description

      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 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.

Why should attend ?

• Build your team
• Review vulnerabilities
• Incorporate the company defense plan into your overall food safety plan
• Establish preventive controls
• Verify implementation of defense strategies (assure your plan is in place)
• Establish a preventive validation approach (prove your plan works)
• Develop procedures
• Document the process
• Protect your company and personnel from lawsuits