The row between the Food and Drug Administration (FDA) and Fresh Del Monte Produce, which has led to the fruit and vegetable company filing lawsuits against the US food watchdog and Oregon Health Authority, poses some difficult questions for regulators, politicians and for companies.
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Campaigners have branded the move, relating to the restriction FDA has placed on importing cantaloupes from Guatemala following a salmonella outbreak, as irresponsible and against consumer interests. Fresh Del Monte says it is defending its business and its reputation.
The FDA, as signified by its reluctance to comment not only on this case but on any other past legal challenge to the agency, appears rather rattled by events. This is perhaps not surprising. As academics, analysts and campaigners have suggested, the threat of litigation by food companies over such interventions could make an already challenging job even more difficult.
The FDA’s task is difficult because epidemiological evidence in food contaminations is often inconclusive. But outbreaks require quick, decisive action at the earliest opportunity to prevent illness and death. The agency knows it will be heavily criticised if it fails to act quickly and more harm is caused.
Campaigners are clear: the FDA must have the freedom to work on a precautionary basis. Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, says Fresh Del Monte’s insistence that the FDA provide “smoking gun” evidence to back up such bans is unreasonable and against the public interest, as finding such evidence is often not possible. DeWaal says this type of lawsuit could have “a dangerous chilling effect on the willingness of public health officials to recall foods or ban unsafe imports for fear of retaliation in court”.
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By GlobalDataProfessor Mike Doyle, director of the Center for Food Safety at the University of Georgia, believes it would be a “major concern” if epidemiologists have to show “definitively” that a certain food is the source of an outbreak.
“It’s not all that easy to isolate the causative agent from the implicated food and so it’s based on statistical analysis in a large part, and some statistics are stronger than others. It depends on how good the case control study, how many people you’re able to get involved in the case control study and so on. And so sometimes it’s more difficult than others to determine whether that food was the actual source of the outbreak or not. It’s a hard call in some cases.”
Doyle believes it is testament to the skill of government epidemiologists that they have such a good record at correctly identifying the sources of contaminations. “My experience is that they’re right a whole lot more than they’re wrong,” Doyle tells just-food.
Fresh Del Monte is brazening all this out. Dennis Christou, vice president marketing, North America, says the company “reluctantly” took this action “to protect our reputation as a trusted supplier” and “open a long-needed dialogue among the public, the industry and the government to develop effective and reliable means to protect consumer safety”.
The suggestion that this is in part aimed at fostering a debate over food safety policy is particularly interesting in light of the passing into law in January of the Food Safety Modernization Act, which gives the FDA legal powers to enforce food product recalls. Previously, it could only recommend recalls, which were then implemented in cooperation with food companies.
Industry has been uneasy about this development. Some commentators have suggested that the Del Monte case represents an early warning for government that one way companies may seek to respond to this tighter regulatory control is through the courts.
Christou says Del Monte “recognises and agrees that product recalls can be an effective means of protecting the public’s health and safety”, but he says the investigation must be “comprehensive and reliable”. He continues: “When a product recall is later determined baseless due to a failure to conduct a comprehensive and reliable investigation, the public health is not protected.” Inaccurate advice can “undermine public confidence in the government agencies”.
He says the FDA’s action was based on “misleading allegations” made “despite the lack of a substantive factual basis”.
However, Doyle believes the frequent presence of doubt places an onus not only on the regulator to err on the side of caution, but also on companies. “It’s very important for a company to look at this from the perspective of what’s best for public health. It’s very important to put public health before the economics, and if there’s doubt and questions that a company does not have product that is safe, it’s important to err on the side of safety.”
Fresh Del Monte may see this move as a means of restoring its reputation. Doyle’s contention is that it will do the exact reverse. “In the long run it’s going to hurt more than it’s going to help Del Monte”. Doyle says consumers will see this as the FDA “looking out for our interests as consumers”, and Fresh Del Monte as “a big company looking out for its economic benefits”.
The degree to which companies have to make sacrifices to support effective consumer protection lies at the heart of this issue. The science is often far from wholly conclusive – the search for a smoking gun is often a vain quest. A functioning food safety infrastructure relies on cooperation between industry and government agencies, in order to act quickly and with a strong precautionary element.
Interestingly, the FDA has just announced two pilot projects under the auspices of the Food Safety Modernization Act, one for produce and one for processed food, aimed at enhancing both the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
When announcing the pilots, FDA deputy commissioner Michael Taylor stressed the importance of stakeholder engagement and said key stakeholder groups, including industry, would have input into the pilots. The FDA therefore clearly recognises the value in fostering a strong cooperative relationship with industry. But such cooperation requires mutual trust and it is clear that in the Fresh Del Monte case any semblance of mutual trust has broken down.
Fresh Del Monte has been at the sharp end of criticism for its legal moves, suggesting companies may remain wary of taking similar steps, at least for now, but the genie is perhaps out of the bottle. Given the new powers invested in the FDA under the Food Safety Modernization Act, it would not be surprising to see an increase in legal challenges to food safety interventions in the future.
This would surely be a backward step and campaigners are right to fear such a development.
The Act is designed to improve consumer protection. An increasingly litigious environment around food safety, with government agencies living under the constant threat of legal action, would be a most unwelcome consequence and would not be in the consumer interest.
Consumers would clearly be best served by politicians, industry and the regulators themselves striving to see this potentially damaging case quickly resolved, while working to establish an enduring spirit of trust and shared responsibility between industry and food safety authorities.
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Oregon Health Authority