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If it is “reasonably foreseeable” that a consumer will eat your food product without further processing, it is to be considered ready-to-eat – and you are responsible for all the FSMA requirements that go along with that – including those of environmental monitoring and control. According to the Code of Federal Regulations Title 21, “Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.” I would see the two key phrases in this definition as being “including a processed food” and “reasonably foreseeable.” For “processed food,” let’s use frozen vegetables as an example. I’ve known people to snatch a frozen bean or two off the cookie sheet before placing them in the oven. Of course, the directions say they are to be cooked, but would that exonerate the manufacturer if a consumer were to become sick from, say, a Listeria contamination? To bring it even more current – let’s talk about flour, which has had recent recalls for E. coli contamination. It is intended to be further processed in the home for baked products. Is it specifically labeled as such? Is it reasonably foreseeable that a consumer may eat it raw, i.e., in raw cookie dough? We could name any number of products that are not intended to be eaten raw but with today’s unconventional food trends, it is becoming more and more “reasonably foreseeable” that a consumer will eat non-RTE food without further processing. Even while the food industry is seeing emerging risks in pathogenic contamination, the trending consumer belief toward less processed=more healthy is taking a vast array of raw and minimally processed foods closer and closer to RTE. How much precaution should be taken by a manufacturer of a raw or processed product not intended to be eaten without further processing, and how liable would that company be should someone fall ill? FSMA’s Preventive Control Rule provides some very stringent environmental monitoring and control requirements for RTE foods, based on the Food Code’s definition of “reasonably foreseeable.” At what point do you need to consider your product to be RTE? And … what does the shift to RTE from non-RTE mean in managing your regulatory, operational, and brand risk? It’s not a new issue – in fact, there have been flour recalls every year since at least 2015, but people are still eating raw cookie dough, with many assuming that if it has no raw egg, it is safe. But more than one of the contaminated flour issues has resulted in illnesses and hospitalizations. Even though those were, in all probability, due to the consumption of raw, or at least under-baked flour-containing foods, there is a point at which manufacturers should at least consider taking that next step in prevention and implementing FSMA’s environmental monitoring and controls specified for RTE foods. And, to reiterate what we said in our newsletter of almost exactly a year ago: consider convening your food safety team to delve further than ever before into the question: Are we actually producing an RTE product? And, if we are, what are our risks, and what can we do protect the consumer and our brand? If you are attending next week’s IAFP Annual Meeting in Louisville, Kentucky, we would encourage you to join us in the panel roundtable Today’s RTE Redefined – Managing Environmental Controls and the Risk of the “Reasonably Foreseeable,” Monday, July 22, 2019, 1:30-3:00 PM. Moderated by Lisa Lupo, Quality Assurance & Food Safety (QA) magazine, panelists David Acheson; Eric Brown of FDA CFSAN; Scott Hood, General Mills; Sean Leighton, Cargill; and Martin Wiedmann, Cornell University will further discuss this topic and provide solutions. If you are not attending IAFP or can’t be at this session, contact us. Controlling environmental risks in the food facility and being able to demonstrate effective control through a robust environmental monitoring program (EMP) is not only a critical part of a food safety program, it has become a regulatory requirement under both the U.S. FDA and USDA/FSIS, as well as Canada’s CFIA. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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