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Reasonably Foreseeable RTE – With or Without Oversight


The government is reopened, FDA is back at work in full force – at least through mid-February. Did you continue to conduct top-notch food safety practices and inspections during the shutdown – even while knowing no one was looking over your shoulder? Having continued to work with companies highly focused on food safety, and seen voluntary recalls announced by food companies based on their own inspections and/or testing, it is evident that the industry’s long tradition of self-policing continues with or without the FSMA-acquired regulatory oversight and authorities of FDA.



That said, one area that often does not get the attention it needs is that of consumer consumption of certain foods straight from the package without consideration for cooking/baking directions. It is because of such use that the CGMPs of FSMA’s Preventive Controls rule emphasize the need to treat a non-RTE food as RTE when it is “reasonably foreseeable” that a consumer may eat it without further processing (e.g., cooking or baking).

Ready-to-eat (RTE) food is defined in the rule as “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.”


But the very acts of determining what is “reasonably foreseeable” and distinguishing a food to be “reasonably foreseeable” as RTE can cause great consternation. For example: You process flour intending for it to be used primarily in baked goods – but what about no-bake, flour-based cookies? Your frozen vegetables include cooking instructions – but salsas and salads often use raw corn. Your cookie dough label clearly states a warning to not eat raw – but we all know how that goes. What’s more, consumers can find numerous online recipes for raw uses of all these (as well as – to my surprise – “expert” citations that it’s okay to eat raw cookie dough because the risk is “pretty slim.”)


It is for such reasons that it is imperative that food producers know how consumers are, or may be, using your product. If FDA determines that raw use of your product was reasonably foreseeable (and those online recipes could provide the first clue), you will be held to RTE standards. So, it is vastly preferable that you determine it first and take steps to ensure that the food is safe without further processing by the consumer.


One of the primary requirements of RTE foods is that of environmental controls and monitoring. Thus, if you have any inklings that consumers are consuming any of your products without further processing – regardless of how you’ve labeled it, it’s a good idea to implement environmental controls and conduct environmental monitoring, at the very least, along the process flow of these products. You may also want to think about increasing your supply chain controls for the ingredients in these products.


If you, yourself, are a supplier of ingredients for a product that a consumer may (reasonably foreseeably) use as RTE, it’d be advisable to conduct your own testing as well. With FDA’s ongoing use of whole genome sequencing (WGS), foodborne illnesses are being linked across geography and time, so that an outbreak from a food for which you supplied ingredients is easily linked back to you. So even if your supplier agreement did not require extensive controls or testing because the final product was not intended as RTE, if you’d see such consumption as reasonably foreseeable, you’d be well-advised to take preventive action.


For more information on RTE Foods, Environmental Controls, and WGS, see our related posts:

or contact us for consultation.



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. www.AchesonGroup.com

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