It’s no secret; FSMA compliance is challenging. And for facilities under both FDA and USDA jurisdiction, there are plenty of grey areas needing addressed to achieve dual compliance. Here, Craig Henry, founder of Intro Inc., answers my questions about the challenges and grey areas of FSMA implementation, some of the differences between USDA and FDA regulations, and how uniformity between the agencies could address some of the ambiguity of compliance. Henry will be the keynote speaker at the 2017 Annual AAFP Conference held September 19 to 21 in Springdale, AR.
Food Online: FSMA’s been in its implementation phase for nearly a year. What are some of the issues affecting how food safety programs can best meet FDA and USDA requirements?
Henry: The FDA commissioned the development of 25 commodity-specific technical reviews to support the implementation of FSMA around six years ago. Without question, all stakeholders would benefit greatly from the “best practices” and science-based content that can be provided by the FDA for specific commodities through such guidance documents. Most stakeholders know the FDA is now considering the recent Presidential Executive Order minimizing the issuance of any additional regulations. It appears that guidance documents are also caught up in that legal review. Whenever the FDA provides commodity-specific guidance to the public, it should be aligned with other agencies, such as the USDA, to minimize ambiguities thus allowing more-effective and less-burdensome food safety programs to be developed, especially in dual inspection facilities.
Food Online: Why is it important for both agencies to be aligned and uniform in reporting adulterated foods?
Henry: Many stakeholders have found the FDA Reportable Food Registry (RFR) very helpful as it provides some insight into what the FDA deems a serious risk to the public. Under the FDA RFR, only reportable food that meets Class I recall criteria must be reported. However, USDA Food Safety Inspection Service (FSIS) notification requirements apply to all adulterated or misbranded meat and poultry products and not just Class I recall criteria. Additionally, amenable stakeholders are not required to post violative tests in the FDA RFR and USDA FSIS plants are exempted. It is obvious that the FDA, the USDA, and ideally, state regulators could become better aligned on reporting criteria involving the two very different registries.
Food Online: What are some of the concerns regarding recalls from both agencies? How could alignment and uniformity address them?
Henry: Over the past several years, we have seen more recalls occurring for Non-Ready-to-Eat labeled foods that have been identified to contain certain pathogens. It appears we are more rapidly approaching a “zero tolerance” for certain pathogens by both the FDA and FSIS. Alignment on the definition of Non-Ready-to-Eat labeled foods by the two agencies would benefit all stakeholders.
Food Online: Over the years, the USDA and the FDA have developed their own requirements for food defense programs. Now, with the implementation of FSMA, the FDA has a defined rule that amenable facilities must comply with. How aligned are the USDA and the FDA on their approach to intentional adulteration?
Henry: I served as the Co-Chairperson on the Food Ag Sector Coordinating Council for five years. During that time, I clearly saw that addressing food defense is not the same as food safety and requires a customized approach for virtually every facility. The HACCP-style approach by the FDA has created a great deal of angst over the documentation and man-hour workload required to comply. The FDA and the USDA have provided some excellent online tools to assist amenable facilities develop their plans. By contrast, for many years the USDA FSIS approach allowed an amenable facility to complete their simple online checklist (17 pages) to characterize their risk assessment and define mitigations. Again, one can easily see how frustrating this can be for a dual inspected facility and others.
About Craig Henry
Craig Henry served as the Vice President of Business Development for the Americas at Decernis until his retirement in January 2017. Prior to joining Decernis in January of 2014 he served 3.5 years at Deloitte & Touche LLC Director in the advisory practice. Prior to joining Deloitte in 2010 Dr. Henry served as Senior Vice President in the Scientific and Regulatory Affairs department of the Grocery Manufacturers Association (GMA) and as the Executive Director of the GMA Science and Education Foundation. Dr. Henry is an accredited trainer for HACCP and the Food Safety Modernization Act (FSMA) Preventative Controls for Human Food. He is also a recognized FSMA Preventative Controls Qualified Individual. Dr. Henry served two terms on the National Advisory Committee on Meat and Poultry Inspection. Dr. Henry can be reached by email at email@example.com.