The FDA Final Food Defense Rules Under the Food Safety Modernization Act (FSMA)

FSMA Food Defense Rules

The rules apply to all foreign and domestic companies required to be registered with the FDA, except farms, very small businesses, animal foods, alcoholic beverages, and operations in which 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.

• 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.

• 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
• Preventive Concepts
• Verifying and validating food defense plan implementation
• Test and correction.

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.

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.

• Upper and Mid-level personnel from all registered food operations
• Food safety team members
• Food quality personnel
• Managers and supervisors in food operations
• Sanitation specialists and teams
• Food packing, processing, distribution and handling personnel
• Food ingredient suppliers
• Legal team members focused on food safety
• Food safety leads and implementation team members
• Maintenance operations personnel
• Food facility personnel
• Food importers whose food will be consumed in the U.S.
• Food security personnel
• Recall specialists
• US Food Importers and Exporters to the US
• Food Safety internal and external auditors and audit team members
• Shipper Supervisor and Managers
• Drivers
• Distribution center operations personnel
• Carrier and food transportation management
• Food Buyers and Supply Chain Qualifiers.