In 2011 food safety in the United States was ready for transformation. In a nation where 48 million people get sick and 3,000 die each year from foodborne illnesses, a series of product recalls had raised public awareness and drove enough political courage to pass comprehensive food safety reform legislation with this bold introduction:
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
But changing politics and stakeholder pushback have delayed FSMA implementation by more than three years. The first wave of regulations was finally published last month. FDA stipulated that they still need “additional funding to fully implement the modernized food safety system envisioned by Congress,” and Politico estimated “funding is more than $276 million behind where it needs to be”.
FSMA starts us in the right direction with its focuses on risk-based preventive controls, which try to anticipate and block potential incidents from occurring, and corrective actions, which require process errors to be addressed if they could affect food safety. Greater scrutiny of imported foods and domestic fresh produce are also good moves.
Transforming Food Safety Culture
What I like most about FSMA is that it creates an opportunity to transform food safety culture. By embracing Lean concepts like preventive controls and corrective actions, FSMA opens the door to more broadly aligning food safety with operational excellence, a personal mission of mine after experiencing both worlds and seeing the great synergy.
I don’t mean that FSMA by itself will transform culture. Actually, if viewed through the fairly common but inaccurate perspective that food safety innately drives operational cost and inefficiency, then FSMA could appear be a threat that needs to be minimized.
But thought leaders in the food industry are starting to see that the historical friction between food safety and operations is mostly a legacy of the inspection-centric past, where the food safety specialist served as the “bad cop” stopping product shipments and discarding merchandise, and food safety and operations operated in separate silos.
When fundamental Lean principles like containment and correction of process defects coexist in the food safety vocabulary, more collaboration will follow. In the prevention-focused future, for example what Lean calls Failure Modes and Effects Analysis (FMEA) looks a lot like what food safety calls Hazard Analysis Critical Control Point (HACCP).
And when the food safety supervisor insists on employee life skills like washing their hands after using the restroom, the psychology is the same as Lean line supervisors insisting that operators keep their work area clean.
Innovators are realizing that by finding the alignment of food safety and operations, we will deliver Lean food-safe processes and transform the food safety culture in the U.S.
- “CDC Briefing on the Burden of Foodborne Disease Illness Papers”. U.S. Centers for Disease Control and Prevention. December 15, 2010.
- Evich, Helena Bottemiller. “Why President Obama and Congress turned their backs on food safety”. Politico. July 14, 2015.
- “Frequently Asked Questions: Questions & Answers on the Food Safety Modernization Act”. U.S. Food and Drug Administration.
- “FSMA Final Rule for Preventive Controls for Human Food”. U.S. Food and Drug Administration.
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