Robert Sanderson - Comment

This comment is being submitted relative to "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Draft Guidance" The purpose of this comment is to attempt to introduce some perspective into the discussion of the safety of leafy greens and other fresh produce. According to "II. Background" in the proposed Guidance, there have been 949 illnesses and 5 deaths in the U.S. attributed to pathogens on leafy greens, from 1996 to 2008. On the face of it, this indicates a significant problem- as is evident from the need to issue the proposed Guidance. 949 illnesses over the 12 year period comprises 79 illnesses per year. Since the population of the U.S. is about 360 million people, this indicates that the chances of any individual getting sick from eating contaminated leafy greens is about .00000022 per year, or about one chance in 10,000,000 of being made sick from leafy greens in any one year. This is small comfort to those who may have suffered extreme illness, or been close to people who may even have suffered permanent injury or death. However, a risk should be evaluated relative to benefits, and to unforeseen additional risks that may result from reducing an already statistically small risk. We have a situation where the microbial risks that are associated with fresh produce are miniscule compared with the immense and growing health crisis associated with obesity, which manifests itself in a range of physical problems and diseases that are exponentially greater than the health risks associated with microbial contamination of fresh produce. It is unlikely that the consumption of leafy greens contributes in any significant way to the growing obesity epidemic. It is also important to consider that microbial contamination is not a significant concern with foods that are primarily associated with obesity, since obesity seems to be largely a consequence of the over- consumption of processed foods that are apt to be nearly if not completely sterile. If there were a way that 360 million Americans could drastically reduce their consumption of processed foods, and drastically increase their consumption of fresh foods, including raw leafy greens, then we would probably see a significant increase in food-borne illness caused by microbial contamination. But would we also see a significant decrease in obesity and its related illnesses, and might not the overall health of the population improve? It might be argued that although it would be a good thing if people's eating habits were improved, this is a separate issue from the microbial risks associated with fresh produce, and that we need to further reduce the risk of microbial contamination on fresh, healthy foods while at the same time making every effort to improve people's eating habits. It might even be argued that making fresh foods microbially safer might induce people to eat more fresh foods and less processed foods. However, the fact that there is presently a one-in-ten-million-chance-per-year of getting sick from contaminated produce makes it unlikely that many people would change their eating habits if the chance of getting sick were reduced to, say, one-in-twenty-million-per-year. In fact, it might be argued that the microbial risk associated with fresh food, real though it is, is being grossly exaggerated relative to actual per capita risk, and the risk of obesity-related degenerative disease, being harder to trace to specific agents, has not led to the issuance of a Guidance for Industries involved in the production of processed foods. An underlying question is: what, if any responsibilities does the US FDA have in guiding public opinion in the areas of science and risk, or should this information be purely determined by market forces, with the FDA reacting, rather than leading?