The Great Fresh Del Monte Corporate Food Safety Culture Fail

It’s finally breaking across the food safety blogosphere (here, here) that Fresh Del Monte will not follow through with a threatened lawsuit against the Oregon Health Authority, who in 2010 traced a cluster of Salmonella illnesses to Fresh Del Monte cantaloupes grown in Guatemala. As an impressionable, shoot-from-the-hip student of foodborne disease outbreaks, food safety and quality management, and crisis communication, I have used this blog more than once to voice my shock and grave concern over Fresh Del Monte’s decision to publicly threaten this lawsuit. So now that Fresh Del Monte has decided not to follow through, what do I think of the end of my favorite corporate food safety culture case study?

All that remains of this once strong Fresh Del Monte-consumer relationship are the broken pieces of trust on the floor. The company has indicated through its actions over the past year that it does not understand public health surveillance, which I believe is a cost-effective tool for identifying and preventing preventable food safety failures. It is difficult to trust the safety and quality of a product from an organization that does not appear to understand the systems-nature of its food safety mission, nor does it appear to communicate effectively with system partners, nor does it demonstrate industry leadership to improve food safety. The red and yellow Fresh Del Monte logo now stands out on products like a flashing, whistling warning of a toxic organizational culture of product safety and quality. I have seen this logo in my Minneapolis retail stores and have asked the management of each store to reconsider carrying the brand. I have seen this logo in street markets in Hong Kong. I have seen this logo on fruit served by carts in Disneyland. Each time I have passed. And anytime my Twitter followers ask what all the fuss about Fresh Del Monte is, I tell them.

Now I do not know Fresh Del Monte executives, their true intentions, or the actual corporate culture of food safety. For all that I know, they could lead the produce industry in high-tech FSQM systems. Perhaps I am being juvenile and strident by publicly criticizing the organization without ever having spent time inside. Unfortunately, the real issue is that CONSUMERS are reshaping their perception of the Fresh Del Monte brand based on how its leadership has handled food safety incidents in the past, and that should concern every organization in the food and agriculture sector.

What is it going to take to change my thoughts on the Fresh Del Monte brand? They are going to need to convince me that they understand the value that public health surveillance adds to the food industry and public health, hopefully in a non-outbreak scenario!!! I do know it will be nearly impossible without leadership change. The organization needs to be lead by someone who listens to and works with system partners, and I observed the opposite behavior from Fresh Del Monte leadership over the last year. The fact that Fresh Del Monte is arrogantly spinning the dropping of the lawsuit as a “show of good will” doesn’t assure me that they have learned anything, at all, throughout this self-inflicted, preventable PR nightmare.

Is your health department running?

An Osterholmian analogy…

It occurs to me that your health department is a lot like your refrigerator. If you live in an area of the United States that pays for a state or local health department that has “the prevention and control of foodborne/infectious/communicable disease outbreaks” in its mission statement, then you are investing in both to keep your food choices safe.

Would you buy a refrigerator that determines its own performance level, not necessarily with the goal of maintaining a temperature that keeps food safe?

Would you buy a refrigerator with no thermostat and that continues to operate when the door is left open?

Would you buy a refrigerator that does both of the above, but only between 8am-5pm Monday-Friday?

Would you trust this refrigerator to keep your food safe?

Now,

Would you buy a health department that investigates outbreaks at its leisure instead of in response to public demand?

Would you buy a health department that does not advocate for improved surveillance laws and that does not measure and manage its own performance during outbreak investigations?

Would you buy a health department that can only work 8am-5pm Monday-Friday, even during large outbreaks (emergencies) that sicken hundreds of people?

Would you trust this health department to give you the information you need to make safe food choices?

We ALL do to some extent.

But,

I have to admit it’s getting better, a little better all the time. (It can’t get no worse)

Reflecting on CSTE’s 2010 Food Safety Epidemiology Capacity Report

Today the CDC MMWR published Food Safety Epidemiology Capacity in State Health Departments — United States, 2010. The report details the results of a survey sent to state and local health departments meant “to count and characterize the food safety workforce in local, regional, and state health departments and to measure and evaluate core capacity to detect, investigate, and respond to foodborne diseases and outbreaks.”

This research fascinates me and I tip my hat to the authors for a job well done. While I’ve not seen the questionnaire used in this survey, and I believe that some of the statistics are very difficult to interpret without more information, a few things do concern me, and should concern anyone interested in public health accountability and effectiveness.

  • 27 states do not prioritize foodborne disease outbreak investigations. How many of those 27 states have foodborne disease surveillance programs? What is contained in the mission statements of those programs? (It is the promise they make to the tax-paying public) How many of these states want more epidemiologists to reach full capacity?
  • 20 states do not have laws that allow them to pay epidemiologists overtime during investigations. Are these public health authorities relentlessly lobbying to have those laws changed? Do states restrict police and firefighters to responding to disasters between 8-5 Monday-Friday? No, because if they did, police and firefighters could not meet the needs of the tax-paying public. Foodborne outbreaks are similar to disasters with tremendous costs to the public’s health and the industry, however they are not typically thought of as disasters because they are geographically and temporally dispersed, and the responders are not from the emergency management discipline. How many of these 20 states reported they needed more epidemiologists to reach full capacity? Do we need more people to work 8-5 or do we need to be able to pay experts to work overtime when appropriate?
  • Only 27% of departments plan to implement the CIFOR guidelines to improve foodborne outbreak responses. How many departments that do not plan to vigorously review and implement the CIFOR guidelines, as well as other continuous quality improvement activities, report that they need more epidemiologists in order to reach full capacity? Do we need more people to do an inefficient process, or do we need to define an efficient process and plan for surge capacity?
  • Finally, how does reported capacity to investigate correlate with actual program timeliness and effectiveness outcomes and program quality as perceived by the tax-paying public?

I personally believe that foodborne disease surveillance programs exist, at the very least, to provide accurate and timely risk information to consumers in real time, not just to crank out annual summaries of data. If our nation’s foodborne surveillance authorities are divided about the importance of participating in outbreak investigations and informing the public, then public health is absolutely failing in it’s promise to the American people. In order to solve multi-state outbreaks in a timely and accurate manner, we absolutely need a shared understanding of the urgency of these outbreaks. We also need a shared understanding of how to investigate. The public relies on the efficient cooperation of state and local health departments and the CDC for actionable risk information. When our system’s vision is fragmented, our performance in terms of timeliness and accuracy will likely suffer! (See my latest post about Adm Thad Allen, USCG (Ret.))

I ask fellow public health professionals: Are we a service organization or a summary organization? Do we answer to the needs of the tax payers and other partners, or are we above public accountability because we believe deep in our hearts we are doing the right thing? Do we share information and provide services that meet the needs of the people that keep us in business?

Admiral Thad Allen, USCG (Ret.): Multistate Foodborne Outbreak Guru?

For those of you who don’t know me personally, read my blog or follow me on twitter, I have two great passions in life: emergency responses, especially to foodborne disease outbreaks, and leadership. I recently came across a Harvard Business Review interview with Admiral Thad Allen, USCG (Ret.) in which the Admiral reflects upon his leadership during the federal emergency responses to 9/11, Hurricane Katrina, the earthquakes in Haiti, and the Deepwater Horizon oil spill. His response to the first question in the audio interview posted on HBR.com reflects on the complexity of leading through complex disaster responses involving several agencies, and it should weigh heavily on foodborne disease outbreak leaders in government, industry, academia, and consumer groups. My complete thoughts on the brief quote below:

Admiral, facing such a big, complicated crisis, how do you start? Do you approach this like a military operation?

“…When you move into what I’m going to call a whole-of-government response, and this is a hurricane response, an oil spill, doesn’t matter what it is, you’re really not talking about unity of command at that point you’re really talking about unity of effort. Because what you have is a number of cabinet officer, cabinet agencies, that have different jurisdictions, responsibilities, all of which come to bear on the problem, all of which can be used to address the problem, but also carry with it responsibilities for them to actually do their jobs.”

Coordinated investigations of foodborne disease outbreaks are also complex in that they require the coordination of dozens of state and local health departments, CDC OutbreakNet and PulseNet, FDA, USDA, potentially DHS (Department of Homeland Security), and one if not dozens of food producers, manufacturers, distributors. Typically the governmental investigation process is coordinated by CDC OutbreakNet leaders who coordinate information sharing, hypothesis generation, and continuous cooperation with federal regulatory agencies responsible for contacting food companies and state and local health departments responsible for interviewing outbreak cases. Often an Epidemic Intelligence Service (EIS) Officer will lead the response by compiling state epidemiological data, facilitating conference calls, and interacting with federal regulatory agencies. The ability to communicate a sense of urgency in the investigation, empower partners, and manage extreme complexity are leadership talents that could increase the performance of cooperating partners and the timeliness of the response system as a whole.

“So the number one issue in my mind is creating unity of effort. And creating unity of effort will vary with the specific incident you’re involved in, having been involved in several recently including 9/11, the Haitian earthquake response, Katrina, and the oil spill, how you achieve unity of effort is slightly different in each case based on the demands of the situation and the effects you’re trying to achieve but overall what you’re trying to do is aggregate everybody’s capabilities, competencies and capacities to achieve a single purpose, still taking into account the fact that they have individual authorities and responsibilities.”

Foodborne disease epidemiologists are aware of variability in the epidemiological presentations of outbreaks and its impact on the course of outbreak investigations. Depending on the supply-chain complexity of the food item that is causing a cluster of human illnesses (One brand of melons vs. one peanut paste present in 2,000 commercially available products), an outbreak investigation could require months of epidemiological interviews, dozens of product tracebacks, and interaction with hundreds of food companies. Creating a unity of effort (and thus achieving desired effects) during a multistate foodborne outbreak investigation requires talent proportional to the complexity of the outbreak.

Undoubtedly the course of the investigation can have consequences on the unity of effort. During the 2008 outbreak of Salmonella Saintpaul associated with Jalapeno and Serrano peppers, a long and difficult outbreak investigation and an ultimately erroneous public health advisory created doubt in governmental credibility and competency during the latter days of the outbreak. Similarly the long, difficult, and confusing investigation of E. coli O104 associated with fenugreek sprouts in Europe drew criticism from experts from across the world. These effects can create challenges for leaders who must achieve unity of effort to identify the cause of the outbreak and take public health action if necessary. (Which poses the question, can a unity of effort be achieved if Fresh Del Monte is ever again circumstantially involved in outbreak investigation leadership? Despite a recent major lapse of professional trust I trust that the answer is yes.)

“That makes it a much more complex matrix to manage and it makes it a much more complex management challenge, but it’s a feature of our democratic government and its one of those things where we need to start raising leaders that have the capability to do that.”

Which brings us to how we train leaders for foodborne disease outbreak investigation and control. Leaders include environmental health specialists and epidemiologists in state and local health departments, CDC OutbreakNet and PulseNet leadership, inter-agency liaisons, regulatory agency leadership, and food industry senior leadership, all of which manage complexity on some scale during their participation in a multistate investigation. What is required in an outbreak investigation leader, and how much of what is required can be trained? With a background in organizational culture, one could hypothesize that an experienced, well-known and influential leader in a central role such as OutbreakNet would be more able to create unity of effort early in a multistate outbreak investigation than a rookie, given an intimate knowledge of the system, acquired experience from past outbreak investigations of varying complexity, and long-standing relationships with leadership in cooperating agencies.

However upon first examination it appears that our current system of multistate foodborne disease outbreak investigation coordination at CDC is not utilizing leaders with extensive experience in foodborne disease outbreak investigation. EIS Officers, who rotate in OutbreakNet for two years gain tremendously-specialized leadership skills, yet usually leave OutbreakNet for a higher-paying position in CDC. I don’t question the value of the experience to EIS Officers, but from an emergency management perspective, do they have the acquired experience and influence to lead a national emergency response? It’s not just EIS officers, it’s everyone working their way up the ladder in the federal agencies. Unless employees are passionate about their work, they are able to apply for unrelated, higher-paying jobs in different areas of the federal government.  The actual pay structure of federal agencies provides an incentive for employee turnover, which may be counterproductive to achieving institutional memory, a unified culture of outbreak leaders, and unity of effort in times of crisis.

Does this really matter? Does the system need to change? Do we need to stop relying on EIS Officers as outbreak investigation leaders? Do we need to incentivize career-specialization in foodborne disease outbreak response in relevant federal agencies? A giant leap forward in public health workforce development, knowledge management, and performance evaluation informatics could provide an evidence base for any decisions about restructuring federal food safety responses, although it seems such a breakthrough is years into the future. For the time being it seems the system works somewhat efficiently most of the time, thanks in large part to foodborne outbreak responders like Dr. Ian Williams, long-standing Chief of the Outbreak Response and Prevention Branch at CDC who works closely with EIS Officers in OutbreakNet during multistate investigations. His extensive experience in multistate investigations and relationships with partners bolsters the culture of multistate outbreak responders. But perhaps we should be mindful of the potential importance of leadership in determining multistate outbreak investigation performance in the future and how our current system develops those leaders. Developing a unified sense of urgency and a culture of performance across the federal, state, and local outbreak response system will be a challenge because of the variation in state and local public health laws and the lack of central management of the workforce. Individual leaders of outbreak response agencies should strive to create and support cultures of best practice in order to ensure and improve the overall timeliness of public health action during multistate (and local) foodborne disease outbreak investigations.

On Fresh Del Monte’s Apparent Lack of Food Safety Leadership

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.