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The question is often asked around whether FSMA will make a difference?  Will FSMA reduce the likelihood of outbreaks or recalls and overall protect public health?  My answer to this is that, in time, I believe it will have an impact, but it will take time and will be neither cheap nor easy. This week we thought we would pose these questions in relation to two major foodborne-illness outbreaks involving produce that are currently under investigation. In each, the produce was implicated in a multi-state outbreak that caused illness and death, and both cases are still active. While it is certainly worse to have a foodborne-illness outbreak case count of 888 vs. 15 (as shown in the table below), is it really any better to have had your product cause “only” one death vs. six, or even to have caused “only” 15 hospitalizations?  As noted above, the bigger question, would or could the Produce Safety Rule prevent either of these? At a Glance (CDC & Public Health Canada 1/28/16) Salmonella/CucumbersListeria/Salad Mix Case Count:88822 States:398 Deaths:61 Hospitalizations:19115 Illnesses Begun:July 2015July 2015 Recall:Yes (Sept. 2015)Yes (Jan. 2016) About the Outbreaks Let’s begin by taking a look at each of the incidents and their significance: Salmonella Poona Infections Linked to Cucumbers Imported from Mexico. In September 2015, two cucumber recalls were announced because epidemiologic, laboratory, and traceback investigations had identified them as a likely source of the infections in a Salmonella The cucumbers, sold by Andrew & Williamson Fresh Produceand Custom Produce Sales of California, had been imported from Mexico. To date, 888 people infected with the outbreak strains of Salmonella Poona have been reported from 39 states, an increase of 50 cases since the last update on November 19, 2015. Although the number of reported illnesses has declined substantially since the peak of illnesses in August and September; CDC stated that it has not returned to the number of reported illnesses that it would expect to see (about one every month during this time of year). Thus, the investigation into the source of these recent illnesses is ongoing. Listeriosis Linked to Packaged Salads Produced by Dole’s Springfield, Ohio, Processing Facility. Fifteen people infected with the outbreak strain of Listeria have been reported from eight states since July 5, 2015. All 15 people were hospitalized, including one person from Michigan who died as a result of listeriosis, and one illness was reported in a pregnant woman. Additionally,Public Health Agency of Canada has reported seven people in five Canadian provinces infected with the same outbreak strain of Listeria. It was just last week, though – on January 27 – that Dole voluntarily recalled all salad mixes produced in the Springfield, Ohio, processing facility. Although the investigation began in September 2015, the source of these illnesses wasn’t known until a lab test linked the illnesses to the Dole facility. The Significance Any foodborne illness outbreak is of public health significance, particularly when it results in death. But also significant in these cases was the ability to not only trace the cause but to link what otherwise may have been considered separate incidents. In the case of the salads, laboratory tests performed on clinical isolates from ill people in Canada showed that the isolates are highly related genetically to Listeria isolates from ill people in the U.S. For the cucumbers,whole genome sequencing (WGS) showed the genetic relationship between Salmonella Poona of the ill persons and the contaminated cucumbers. Additionally, CDC reported that the WGS of isolates from people who became ill in October and November are also closely related genetically to isolates from people who became ill during the peak of the outbreak and to isolates from contaminated cucumbers. Although the FDA traceback investigation determined that Rancho Don Juanito de R.L. de C.V. of Baja, Mexico, was the primary cucumber provider for Andrew & Williamson, the source of this outbreak has not been positively identified. But FDA is continuing its investigations to determine if it could be from cross-contamination in the distribution chain, and CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify additional ill people and interview them. Besides the linkages, the current rise in litigation of outbreak cases, not only by consumer lawyers but also by the government, is of significance and concern in any contamination case, particularly if any factors are uncovered that show prior knowledge or neglect by company personnel. So … Would the Produce Safety Rule Prevent These and Similar Outbreaks? At this stage I am not aware of what the cause of the outbreaks were in terms of what went wrong and where.  But let’s look at the six key sections of the rule. We can immediately rule out the sprouts requirements, since sprouts weren’t involved; worker training is focused primarily on hygiene, so could be applicable to the Salmonella contamination, but it would have to be an ongoing contamination so that is not likely. A major section of the rule is focused on agricultural water, specifically on criteria for microbial water quality based on the presence of generic E. coli. That’s not to say that Listeria and Salmonella cannot be transmitted to produce through water, such contamination can rise from floodwaters, septic systems, or soils laden with feces from domestic or wild animals. But the water provision focuses on E. coli –  but maybe these outbreaks are related to water.  It is the section on domesticated and wild animals that establishes the standards for grazing or working animals equivalent to those for intrusion by wild animals. So this section could, potentially have some impact – though more likely in theSalmonella outbreak that the Listeria outbreak. But the sections of the rule having the most potential for impact on such incidents are those on biological soil amendments – which establishes microbial standards that set limits on detectable amounts of Listeria, Salmonella, and other bacteria – and the provision designed to prevent inadequate sanitation of equipment, tools and building from contaminating produce.  I favor the latter as a potential source if it tracks back to the farm – but who knows that anyone will find the smoking gun at farm level. That said, I, personally, think the jury is out as to whether the rule would have prevented this since the rule is about GAPs, and it is likely that GAPs were being followed.  So I suspect that, with the expected level of compliance for the Produce Safety Rule and the ability to exert enforcement, I doubt that the Produce Rule would have prevented either of these outbreaks.  But we must not forget that perhaps the Listeria outbreak was due to a problem in processing  in which case, it would be the Preventive Controls rule that would have impact rather than Produce Safety.  There I think we have a better chance, but nothing is certain and we should not lose sight of the fact that even with the best systems in the world, the unexpected can happen in the world of food safety. 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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