FDA defines a ready to eat (RTE) food as one “for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.” Technically, this would include products intended/labeled to be cooked by the consumer before eating … technically. The key point here is the phrase “reasonably foreseeable” in which a food company needs to understand ways in which their products may be consumed. Reasonably is not defined so it is a judgement call in each case. This is clearly a challenge to the industry as consumer habits and the move to “raw” foods continues to evolve and change. But what about those foods that “no one” eats without further cooking or baking; those for which you include cooking instructions. Is it “reasonably foreseeable” that someone – anyone – will eat that food as is, right out of the package? Are you responsible if someone gets sick? What if it is an ingredient in an uncooked (or undercooked) dish at a church buffet or a college party, causing multiple foodborne illnesses – that is traced back to you? What reasonable due diligence do you need to take on the front end – just in case? These are tough questions. But before we look at the answers, let’s discuss a few examples – such as RTE produce. Both potatoes and asparagus are vegetables that are on the “rarely consumed raw” list of the Produce Safety Ruleand are “therefore, exempt from coverage under this rule.” However, a simple Internet search will bring up recipes using raw versions of both of these. So, what is the processor’s real responsibility for such foods? Particularly when a further reading of the rule states that FDA based its list on 2010 data (as the most recently available) adding, “Therefore, this list may not necessarily reflect or fully reflect current or emerging patterns of forms in which produce is consumed or new dietary trends toward consumption of raw foods.” Given that, should all produce be considered ready to eat, regardless of the FDA distinction? Another example is that of flour. While it is not FDA-listed as ready to eat, there are, again, Internet recipes for no-bake cookies that use flour. And many are unaware that it is not only the raw eggs in cookie dough that can be contaminated, it was actually E. coli-contaminated flour that led to a 2016 outbreak. In fact, the investigation found that foodborne illness had impacted not only those who ate the raw dough, but also those who handled it. Then there are the cases of consumers simply mishandling product – not cooking meats to temperature, thawing meat or other frozen food on the counter, or even simply thawing and eating – as was the case when a college student thawed a frozen, packaged pot pie on the windowsill and ate it as is. So, does consumer lack of knowledge or failure to follow label directions constitute “reasonably foreseeable”? How much responsibility should be placed on processors for knowing about – and protecting consumers in – new dietary trends and forms in which produce is consumed? My recommendation for pretty much all of these would be for processors to proceed with “an abundance of caution” for all foods, considering the worst case and doing as much due diligence as viable to protect, not just consumers, but your own business and brand. One idea would be additional consumer warnings on packaging, as we discussed in our July 2017 newsletter, “Are You Producing an RTE Food … and Don’t Realize It?” While this may or may not influence consumers, it is one more step on your part to communicate, and one more proof of due diligence should the need arise. But, if consumers are not able to read or to speak English, where does that leave you? Clearly more questions than answers. Even more consumer-protective would be the application of environmental monitoring and controls whether or not you are subject to the regulatory requirements of RTE foods per FSMA (as discussed in our January 2017 newsletter on FDA’s draft guidance on control of Listeria monocytogenes in ready-to-eat foods). This is particularly important because FDA is not only conducting environmental sampling in facilities for various foodborne-illness pathogens, its use of whole genome sequencing (WGS) is linking pathogens and illnesses as never before. Between October 2017 and March 2018 (the latest available data), FDA took nearly 10,000 samples in food facilities, averaging about 1,660 each month. Although less than two percent of these were positive, if any of that two percent were to be found in your facility, linked to your facility, or serious enough to cause a recall, it’s likely that you will have wished your environmental program had been more extensive. While it would not be viable to apply RTE requirements to every food in your facility, I would make a recommendation similar to that which I stated last year. That is: with all this, you may want to consider convening your food safety team to delve further than ever before into the question: Might a consumer eat our product without further cooking, baking, etc,. irrespective of what instructions are on the label? If so, what are our risks, and what can we do protect the consumer and our brand? The point of this article is for me to raise awareness even more about where regulators are going and how our food safety landscape, and thus risk profile, keeps changing. There are no clear answers to many of these questions, but the best approach is to, at least, stay on top of consumer behavior, make adjustments as needed and, if in doubt, take a good look at post processing contamination irrespective of the type of food you are selling. 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
