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The FSMA Intentional Adulteration Rule: Dependent upon Past, Present, and Future Collaboration

Wednesday, December 14, 2016

The publication of the FDA Food Safety Modernization Act (FSMA) final rule aimed at preventing intentional adulteration (IA rule) from acts intended to cause wide-scale harm to public health is a major step forward in our collective efforts to safeguard the food supply.  For more than a decade, industry, academia, trade associations, and government partners have collaboratively assessed the vulnerabilities of the food supply and identified strategies to mitigate those vulnerabilities.  The results of this collaboration have formed the fundamental underpinnings of the IA rule’s requirements, including, but not limited to, food defense plans, vulnerability assessments, mitigation strategies, and food defense training.   

As we proceed toward initial compliance dates, collaborative efforts are essential, and we will continue to build upon the solid foundation of existing food defense work.  That collaboration is happening now.  Since publication of the IA rule, we have engaged in important dialogue with the spectrum of stakeholders.  Based on my participation in that dialogue, I’m quite comfortable saying that industry, associations, academia, and government partners are definitely interested in the rule requirements and plans for implementation.  The final rule includes compliance time periods of three to five years to ensure we have adequate time to engage in such dialogue.  Beyond these discussions, there are many other essential food defense activities that lie ahead.  FDA will publish draft guidance for the rule and seek public input.  Existing tools and resources will be updated, and new ones are already being published.  Additional training programs will be created.  Food defense research will drive innovation.  Identification and honing of food defense best practices will continue and be disseminated.  The list goes on and on. 

Adequately protecting something as complex as the food supply requires all of us to work together, and we’ve done an incredible job so far.  The IA rule is a big step toward this goal, but much more work lies ahead.  I look forward to continuing our collaborative efforts!  

Ryan Newkirk
Senior Advisor for Intentional Adulteration, FDA