HANK GICLAS | SR. VICE PRESIDENT, STRATEGIC PLANNING, SCIENCE & TECHNOLOGY SCIENCE & TECHNOLOGY
The Anatomy of the Outbreak Investigation As a cog in the machine of the Leafy Greens Task Force (a coalition of produce companies, trade associations and others committed to understanding the recent outbreaks associated with romaine and developing steps to prevent further occurrence), I wanted to share my perspective on some of the difficult issues that have been focal points of discussion for that group with regard to the recent E.coli outbreak.
The first thing on my list is how the Centers for Disease Control (CDC), the Food and Drug Administration (FDA) and industry work together on outbreaks, and the resolutions that stem from that work. Make no mistake, CDC and FDA staff are smart, committed and are accessible to industry during these events. It is their job to discover an outbreak, identify the commodity, identify the source and stop the distribution of contaminated products. Their bottom line is to protect public health and their immense challenge is the need to be both “fast and right.” Typically, though not always, these events start with CDC who uses PulseNet to stitch together reports from discrete state departments of health to confirm that ill people in varying geographies are infected by a common source. Next they interview victims and healthy consumers to determine the likely food vehicle (source). Occasionally, they have product available to genetically confirm the source. To “be right” they strive to have multiple lines of confirmation, including the epidemiologic information, traceback information and microbiological information, but to “be fast” they don’t always have the luxury of confirming all three lines. It is a difficult position for them. CDC and FDA try to keep industry representatives informed as they progress their thinking, and industry representatives regularly make themselves available to answer any questions that will help the agencies progress including offering information about products, seasons, distribution, etc. Industry representatives also challenge the agencies when their hypotheses don’t fit industry patterns. But in reality, there is little that trade organizations can do at this point of an investigation. Once a food vehicle has been identified, the traceback, led by FDA, begins and it is at this point that trade organizations, who understand when, where and how products are grown, sold, transported, and marketed are much better positioned to help. This, however, is when individual companies begin
to be contacted by FDA and FDA will not (nor should not) discuss these lines of investigation at this point because of the reputational and economic implications of naming names. Again the challenge is to be “fast and right” but traceback is a tedious step-by-step process that requires accurate documentation of each node within a supply chain to ensure that the source is identified correctly. Ideally, FDA identifies a clear single source and the collateral impacts to other producers are minimal. In the most recent outbreak and traceback investigation, many cast aspersions on grower and handler traceability programs but delays were mostly within the first step back from the point of sale. While trade organizations can speak generally to supply lines, they cannot connect a point of sale to the distribution center that delivered the product to the store. This is an outbreak in which there are many lines of traceback and no convergence to identify a single source. So because of the seasonality of supplies and multiple lines of investigation leading to a general area, FDA identifies a single region as the source and begins environmental assessments in that region in its attempts to more narrowly define the source. In addition, industry hopes the environmental investigation will help identify potential reservoirs for the pathogen, sources of contamination and mechanisms for introducing contamination into a field. Insight into these factors helps to understand vulnerabilities, what might have gone wrong and how we may be able to prevent future events. While FDA has indicated it is incumbent on industry to “resolve” the issues, and industry embraces this responsibility, this cannot be accomplished without full and transparent access to all the results of FDA’s environmental assessment. In this particular case, it has been an industry imperative to act in advance of the next growing season but we are hindered by FDA’s lack of detail on the results of the environmental assessment—which as of this writing in August may still be underway.
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SEPTEMBER | OCTOBER 2018
Western Grower & Shipper | www.wga.com
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