On August 29th, 2011, Fresh Del Monte Produce announced an intent to sue the Orgeon Health Authority over a 2010 investigation of a Salmonella panama outbreak, ultimately associated with Fresh Del Monte cantaloupes.
Top food safety blogs CIDRAP, Food Safety News, Marlerblog, and Barfblog have provided outstanding commentary about the potential suit. The best knowledge I have about the reason for the suit comes from a Marlerblog post from August 29th, 2011.
“Dr. Keene and the OHA conducted an apparently cursory investigation of the illnesses and concluded that they were associated with the consumption of cantaloupes by the patients who became ill,” reads an Aug. 26 tort claim filed with the Oregon Department of Administrative Services. “Dr. Keene reached this conclusion without ever testing any cantaloupes to determine whether they were contaminated with salmonella.”
“Despite the lack of evidence for their claims concerning Del Monte Fresh’s imported cantaloupes, the Public Health Division and Dr. Keene pushed the FDA to order a recall.”
In foodborne disease outbreak investigations associated with FDA-regulated foods, positive product samples that genetically match outbreak-causing pathogen strains are considered a “gold standard” of proof that a food product is causing disease. Usually state health officials will attempt to obtain and test food product samples from outbreak cases or retail outlets after an hypothesis-generating epidemiological study identifies one or a few possible foods that may be causing disease. At the same time, health officials usually conduct product source tracebacks using regulatory information obtained by a state agriculture authority. In the case of ongoing multi-state outbreak investigations, many state health and agriculture officials work together with the Centers for Disease Control and Prevention and the Food and Drug Administration. The CDC collects and coordinates the sharing of epidemiological information, while the FDA shares its resources and expertise to aid in product traceback, confirm or deny the plausibility of epidemiologically-associated food products causing disease, as well as to obtain and test product samples. The FDA’s role is very important when state health officials are unable to complete a product traceback or obtain and test food samples within their jurisdiction. It is crucial that the FDA is involved in multi-state outbreak investigations from the moment a cluster of illnesses are identified so that the investigation process occurs as quickly and efficiently as possible. Essentially, the epidemiological evidence collected by state health officials and the CDC provides strong hypotheses as to the foods causing an outbreak of disease, and the product tracebacks and product testing performed by state agriculture officials and the FDA provide incontrovertible proof that those foods identified by state health officials are in fact causing foodborne disease outbreaks.
From my own consumer interpretation of the tort claim, Fresh Del Monte seems to think that state health authorities should have to perform regulatory tracebacks, obtain products, and test products before ever sharing an outbreak source hypothesis with the FDA. It seems that Fresh Del Monte is arguing that the FDA should not be involved in multi-state outbreak investigations at all, since it is the responsibility of the states and CDC to collect not just epidemiological evidence, but also to track down and test product samples, before even sharing information about urgent food safety activities with the FDA. Should a state have concrete epidemiological evidence, conclusive product traceback, but not have product samples, and subsequently suggest to the FDA that they are concerned that a food is causing illnesses and deaths, that state is inappropriately encouraging the FDA to contact the producer and consider warning the public without factual basis. Never mind that in most fresh produce outbreaks, product samples cannot be obtained, not even by FDA, because the outbreaks are discovered after all of the produce has been eaten or discarded.
The involvement of the FDA in multi-state outbreak investigations contributes to faster and more accurate outbreak responses. Let’s imagine the highly-unlikely scenario that Fresh Del Monte actually sues the Oregon Health Authority, wins a favorable ruling in court, and states do not share information about outbreak investigation activities with the FDA without first obtaining a positive product sample in order to avoid future lawsuits. If state health officials were to investigate multi-state outbreaks without the immediate expertise and resources of the FDA, the result would not only be more cases of disease because it would take longer to identify the source of an outbreak. Fewer foodborne disease outbreaks would ever be solved without FDA resources, and thus fewer root causes of catastrophic widespread contamination in our food supply would be identified, fewer food safety interventions based on those root cause analyses would be implemented, fewer victims of foodborne disease would be able to take legal action against food producers who hold strict liability for the safety of their products, and the financial incentives for food producers to manufacture safe food would be reduced.
I am not surprised that Fresh Del Monte would fight for what it believes are reasonable standards of foodborne disease outbreak investigation. What does surprise me is that as I interpret Fresh Del Monte’s tort claim and subsequent public comments, the standards that Fresh Del Monte is fighting for are absolutely at odds with the recommendations of governmental, academic, consumer group, and other industrial food safety experts who focus on improving our nation’s emergency responses to foodborne disease outbreaks. The standards Fresh Del Monte is fighting for are plainly counterproductive to protecting the public’s health with absolutely reasonable scientific evidence. It is disgusting, as a consumer, that Fresh Del Monte, a large food company with several in-house food safety executives, would file a suit that would ultimately reduce the ability of the fresh produce industry and the United States government to detect critical food safety failures, understand their root causes, and implement corrective actions either locally or globally.
One has to ask, is this food safety leadership? Is this working towards the common goal of the food industry, government, academia, and consumer groups to reduce the burden of foodborne diseases? Is this action in the interests of all of Fresh Del Monte’s stakeholders? From Fresh Del Monte’s mission statement: “In fact, our long-range vision is to become the leading global supplier of healthful, wholesome and nutritious fresh and prepared foods and beverages to consumers of all ages.” Is this action going to improve Fresh Del Monte’s image with customers or it’s market share? Is this action going to improve the wholesomeness of the products that Fresh Del Monte wants to sell? Is this action going to improve the internal culture of food safety at Fresh Del Monte? By suing to question the methods of regulators, and not even to sympathize with the victims in the press releases or tort claims?
My answers to all of the above questions is “No.” It is clearly time for leadership change at Fresh Del Monte. Not for the sake of governmental public health. Not for the continuous improvement of industry-wide food safety practices. For the health of Fresh Del Monte’s customers.