October 1, 2018

What Have We Learned about FSMA Implementation?

What Have We Learned about FSMA Implementation?

By Food Safety Magazine

What Have We Learned  about FSMA  Implementation?

The Food Safety Modernization Act (FSMA), the most sweeping reform of U.S. food safety legislation in over 70 years, was enacted in 2011, and its implementation is now underway. Through seven major substantive rules, FSMA introduced a paradigm shift in food safety by focusing on the prevention of food safety risks rather than on a response to crises after they happen. Each of the rules plays a specific role in the mandate of the U.S. Food and Drug Administration (FDA) to comprehensively regulate the food industry. FSMA requires transparency from the entire supply chain and fundamentally changes the way food is regulated in the U.S. and abroad, from farm to fork.

Given the wide-ranging impact of FSMA on the food industry, Food Safety Magazine convened an expert panel, moderated by Larry Keener of our Editorial Advisory Board, to address some of the more critical questions regarding FSMA implementation. Participating panelists were David W. K. Acheson, M.D., F.R.C.P., the Acheson Group, John M. Ryan, Ph.D., PCQI, Ryan Systems Inc., Dan Brooks, PCQI, food safety consultant, Willette M. Crawford, Ph.D., M.P.H., Katalyst Consulting LLC, Aurora A. Saulo, Ph.D., University of Hawaii at Manoa, and Tatiana Koutchma, Ph.D., Agriculture and Agri-Food Canada.

Food Safety Magazine (FSM): Describe what you feel are the strengths and weaknesses of the FSMA regulations.

David Acheson: The biggest strength of FSMA is that it has taken us into a comprehensive world of risk-based controls with a heavy focus on prevention. The inclusion of supply chain control and environmental control requirements for RTE [ready-to-eat] foods is a necessary focus in today’s food safety environment. The greatest weakness is that there are some key parts waiting for regulations, such as high-risk foods and the move toward greater requirements for product tracking. The recent romaine outbreak is a good example of that need. Obviously, the lack of resources for both education and inspections continues to be a weakness. I personally don’t like the fact that very small entities are not covered by FSMA; I would much rather they be covered but with more time and education to allow them to get it right. Similarly, the fact that juice and seafood are exempt adds more complexity where a one-size-fits-all approach would have been better.

John Ryan: FSMA regulations attempt to define a complex system-wide set of rules designed to move the food supply chain to improve over the next 50 years. Such changes generally take at least a generation to effectively implement. Current deadlines for “full implementation” are unrealistic.

With little or no ability to rapidly and cost-effectively detect primary hazards at the farm level, contaminants are set to travel through the supply chain with no traceability clearly defined or required. This leaves the public exposed and recall efforts lacking. Greater emphasis must be placed on low-cost, easy-to-implement hazard-detection tools (sampling) that can be put in the hands of farmers for early hazard detection. Traceability must be mandated, and food movement, identity, condition, and location information should be visible as real-time information.

When FDA teams get involved in recall investigations, they ignore “food safety” certificates and head straight for areas where they can take samples for laboratory analysis. These samples provide objective evidence. Food safety audits provide subjective information about food safety. If FDA leans solidly on objective sample data, so should the entire food chain. The industry is being misguided by old-timers in food safety and audit companies that do not shift to dependence on sampling in order to establish preventive control validity.

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