The food industry and our public health agencies have long recognized that they share the same responsibility to protect consumers from unsafe food. The modern food industry is, however, growing more diverse, dynamic, and complex. making the application of food protection throughout the broad spectrum of operations a challenge for industry and regulators alike.
As these food production systems become more complicated, they become riskier, so it is not surprising that meeting our shared goal of reducing the incidence of foodborne illness is a moving target. The persistence of bacterial, viral and parasitic foodborne agents of disease in the food supply, coupled with the many risks inherent in modern production, processing and distribution, result in interactions that increase the threat of contamination.
Consolidation of production into larger and larger plants, long supply chains, a transient, undervalued workforce, consumer demands for convenience, and more fresh processed fruits and vegetables are just a few factors driving negative trends. To protect public health in this time of increasing risk, what is needed is the scientific and systematic application of preventive measures at all stages of production, and then the coordination and cooperation of industry and public health agencies working together to solve problems before they result in a crisis for consumers.
Unfortunately, we are not there yet with the concept of prevention. FDA has seen an increase in the number of foodborne ill investigations it conducted in the last two reporting periods. In 2018 and 2019 there were a total of 32 of these investigations, up from seven nationwide outbreaks in 2017. While there may be other factors influencing these statistics, such as the better detection and investigation of outbreaks, this trend may also mean our preventive controls are not yet working as intended.
The Food Safety Modernization Act and “Risk Based Preventive Controls” has been in effect since 2017, and the industry is responding, recognizing that food safety is in their hands, but it will probably take many more years for the positive effects of this legislation to be realized. Our controls will improve, however, the more we can foster a culture of prevention within our industry and in the regulatory agencies overseeing compliance with safe practices. While this makes total sense, this concept must start with our public health professionals who should lead by example.
Unfortunately, serious issues known to regulators are allowed to persist in too many USDA and FDA operations. An FDA inspector’s response to poor sanitation and safety in their facilities seems to be primarily to issue a form 483a Inspectional Observations or a Warning Letter (meaning likely violations) only to return years later and find the same issues again. Repeat violations include finding pathogens in the production environment and insanitary conditions whereby food should be considered adulterated, with none, or ineffective corrections taken.
FDA seems to be stuck in the old “command and control” model that was supposed to be replaced by the FSMA prevention concept. The old model is where a failing operation only fixes a problem after they have been officially notified or when forced to. FDA is right in wanting to change this situation and foster a culture of prevention within the industry, and industry gets it, but a culture of prevention has to begin with the agency itself. FDA apparently has the legal muscle to take action against repeat violators, but does so typically only after an outbreak has occurred.
The toxic political environment that our public health agencies find themselves in does not help, so given the current state of affairs, we should not be surprised if things get worse before they get better.
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