Over the last year, we have written a number of articles about environmental monitoring and controls, including our recent 2017 predictions that the year would bring continued, or increased, focus on this area by FDA inspectors as they swab facility environments to determine compliance with FSMA’s Preventive Controls and incorporate whole genome sequencing (WGS) in sample analysis. From my perspective, this is one of the most critical areas for food plants that make ready-to-eat food. The risks are high and the consequences can be catastrophic to both your brand and to consumers. While this article will include further insights on FDA inspections (along with a refresher on the FSMA requirement for RTE products), we want to add, at this point, that it’s not just about meeting regulations. Rather, one need only review such major recalls of 2016 as those of frozen vegetables, sunflower seeds, ice cream and hummus – all of which resulted from environmental contamination – to realize it’s just as much a matter of brand protection. Some of these recalls were linked to serious human illness and some were not. Thus, whether talking regulation, recalls, brand protection or consumer safety, establishing an environmental controls program with regular monitoring and validation is, and will continue to be, critical for all food facilities if you make ready-to-eat food To jump back to FSMA and FDA inspections, if you produce ready-to-eat (RTE) foods, your hazard analysis required by the PC rule must include an evaluation of “environmental pathogens whenever an RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment that would significantly minimize the pathogen.” While that is likely already pretty well known to RTE producers, it also is important for all processors to understand that the rule includes as RTE any food “for which it is reasonably foreseeable that the food would be eaten without further processing that will significantly minimize biological hazards.” And the rule then cites raw cookie dough as an example – which puts a lot more food facilities into the RTE category than ever before, and suggests that the FSMA wording to include environmental monitoring “as appropriate to the facility, the food, and the nature of the preventive control” should probably be read, instead, as “appropriate to all facilities and foods.” I think we all struggle with a solid definition of ready-to-eat food and the FDA has not come out with a clear explanation of how they see which foods fall into the RTE group. For example some frozen vegetables that are almost never going to be consumed raw can easily fall into the category of needing to be recalled if they are shown to contain a pathogen such as Listeria monocytogenes or Salmonella. FDA inspectors are looking … and swabbing. In fact, I think that the regulators are on a mission to “map” facilities. That is, the regulators will swab your facility and any positive findings for environmental pathogens will be sequenced and placed in the WGS data base. When subsequent inspections are made of the facility – be it even three, four, or five years later – the new samples are compared to those in the database. If there is a match to prior findings, it’s evident that the facility has a resident strain and you can expect that the regulators will be back in force! The same applies if a human isolate is found that matches any of the pathogens found in the past in your facility. While regulatory compliance is, of course, important, a recently published EU report drives home that fact that it’s often necessary to go beyond the word of the law to truly protect customers. Although the U.S. standard for Listeria monocytogenes is zero tolerance, the EU is a bit less stringent in this area, having an Lm food safety limit of 100 bacteria per gram. However, the report by the European Food Safety Authority (EFSA) and European Center for Disease Prevention and Control (ECDC) showed the EU has seen an increasing trend of listeriosis since 2008, particularly of those over 64 years old – with the highest death toll ever, of 270 deaths, occurring in 2015. Whether or not the EU’s food safety limit is viable for protecting the consumer, the study included an interesting note on its data uncertainties/limitations stating: “it is possible that some of the tested products at retail that are able to support the growth of L. monocytogenes and which were found to contain less than 100 colony forming units per gram (CFU/g) at the time of testing (and which were therefore classified as compliant) may had not been characterized as compliant, had they been tested at the end of their shelf life.” This, alone, could substantiate the need for zero tolerance and robust environmental testing – regardless of the regulatory limit, particularly in facilities producing foods that are able to support the growth of Listeria. This is indeed an interesting comment from the EU who have been as steadfast in the 100 cfu/g concept as the U.S. has been with the zero tolerance concept. However, there is increasing evidence that if the product will support growth – especially if consumers don’t use the product as intended (think of ice cream), then there are clear public health risks. The fact that the EU saw so many cases of listeriosis – and resulting deaths – holds further significance when it is noted that most healthy individuals are virtually unaffected by Listeria. It is the immunocompromised, such as the elderly, along with pregnant women and infants, who are most likely to be affected. So the actual incidence of Listeria-contaminated food could be significantly higher than the statistics indicated. So what does all this mean? As I noted in the opening comment, having a solid environmental control program is critical if you are making foods that could be consumed without a further kill step. We have discussed prior situations where not getting this right leads to criminal investigations and major brand damage. When you look at your environmental control program think broad. Don’t just focus on the monitoring part but think about keeping the pathogens where they belong using GMPs, hygienic zoning, good cleaning and sanitation programs, etc. Then when you find either Salmonella or Listeria monocytogenes in your environment, ask whether you want to know if you have a resident strain before the regulators find out that you have one. As a final word on this topic, if you are able to show the regulators that you have a solid environmental control program of seek and destroy, it may not keep you out of trouble, but it will go a long way toward avoiding some potentially very stressful times ahead when FDA finds problems that you don’t know about. 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
