The Shifting Focus of Food Risk and Food Safety Regulatory Strategy

Over the last 10 years in the United States, we have seen some major food safety catastrophes and some huge changes in regulatory authority in relation to food sold to U.S. consumers. This is particularly true when it comes to food regulated by the FDA, which is essentially all food other than meat, poultry, and egg products.

As a back drop to all these changes, there has been a series of major outbreaks including E. coli O157:H7 in spinach, Salmonella in peanut butter (times three), melamine and melamine-related products in pet food, and Listeria monocytogenes in cantaloupes—to name just a few of the most significant outbreaks.

Another major change in the last 10 years that is particularly relevant to managing risk for food companies, is the American consumers’ perspective on food and food safety. We have seen a huge growth in the desire for organic and natural food, an expansion in the desire to eat local food, and a huge push for information about food, such as country of origin and whether or not it contains GMOs. A part of this increasing consumer awareness is the marked impact of social media on spreading concerns (whether accurate or not) about food issues, and the high profile that mainstream media give to any significant food safety issues.

Often the regulatory role on food issues has been seen as a reactive one. “We have a problem and it needs to be addressed” is a common mode of operation. This began to change in the mid ’90s at USDA’s Food Safety and Inspection Service (FSIS) with the implementation of mandatory HACCP systems. On the FDA side, there were a number of key events that drove change, many of which tie back to the major outbreaks mentioned above.

The first driver for change was the 2006 E. coli O157:H7 outbreak. This situation resulted in the produce industry taking matters into its own hands, especially in California, with the implementation of marketing agreements and marketing orders. At the same time, many in the produce industry were calling for federal regulations around produce safety—this was the beginning of the move toward the produce rule that is now out for comment as part of the Food Safety Modernization Act (FSMA).

The second major shift in perspective was the situation with melamine in pet food. In fact, in many ways this was likely the major driver to some of the new import requirements of FSMA. Why was this a game changer? Three reasons, first it was an imported product; second it was from China at a time when there was a series of issues with Chinese products coming into the U.S.; and third, it was deliberate. This event drove the administration and the FDA to develop a Food Protection Plan which was published in 2007. The plan focused on a three pronged approach—risk-based preventive controls, targeted risk-based inspections, and faster and more efficient response when problems did occur. Sound familiar? It should, it was the basis of FSMA. (David Acheson and the Food Protection Plan also were featured as QA’s Cover Story “Prevention. Intervention. Response,” November/December 2007.)

What moved the needle a lot further was the Salmonella outbreak linked to the Peanut Corporation of America (PCA). This event enraged consumers, the private sector, and Congress to the point where an unlikely alliance formed between regulators, consumers, and the food industry to drive hard for increased regulatory controls. Congress responded, and despite many hurdles and challenges, FSMA was finally signed by the President in January 2011, representing the most sweeping changes to U.S. food safety regulation in over 75 years.

Looking back over the last decade at the world of food safety, we have seen massive change in relation to the global supply chain, consumer awareness, media influence, brand risk, and regulatory authority. I suspect history will view this period as one of the most dynamic decades in relation to food safety. What we have to do in the next decade is implement what we have learned, and continue to educate all in the food chain in the context of the safety of food, but also with the notion that no matter how good you are as a grower, manufacturer, distributor, retailer, or foodservice operator, the system is complex, the microbes are fickle, and we always need to be ready to respond fast and effectively when foodborne illness strikes. Because it will.