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Aggressive Strategy Vindicated
Will the FDA Change Its Approach?

As we were about to push the send button on this Pundit, we received big news from Del Monte Fresh Produce:

Del Monte Fresh Produce N.A., Inc. is pleased to communicate that we were able to reach an amicable resolution with the Food and Drug Administration (the ‘FDA’) resulting in the rescission of the import alert. Del Monte Fresh Produce N.A., Inc. and the FDA have a mutual interest in the creation and enforcement of appropriate food safety measures that protect consumer health. This agreement demonstrates that the FDA and importers, such as Del Monte Fresh Produce N.A., Inc., can work together to achieve this mutual goal.

This is big news, perhaps unprecedented. Though the release is all sugar and light, we can’t help but believe that Del Monte’s legal strategy worked. They brought this issue to a head and got it resolved so they can plant for the winter season. That is not always the way these things turn out 

The imbroglio between Del Monte Fresh and the FDA that we chronicled in our piece, Del Monte Fresh Stands Up To FDA’s Bullying Tactics, and our follow-up, Pundit’s Mailbag — Del Monte Fresh’s Lawsuit Against FDA Draws Attention To Other Mistakes And Policy Flaws, made the big time when William Neuman, who has the food safety beat at The New York Times, decided to highlight the story in a piece titled, Produce Importer in Food Safety Fight:

When health investigators identified imported cantaloupes as the source of a salmonella outbreak early this year, the importer agreed to a recall. But now that company, Del Monte Fresh Produce, is trying to block additional restrictions on melon imports, setting off an unusually public battle between the produce industry and food safety regulators.

The company, which is one of the country’s largest produce marketers, says the restrictions could damage its reputation, and it has sued the Food and Drug Administration to lift them.

The effort is being cheered by many in the produce industry, who often complain about what they call overreaching by regulators and welcome a company with resources pushing back.

But advocates of safe food said that it was extremely rare for a major food company to take such a publicly aggressive stance, and that they suspected Del Monte Fresh Produce was trying to bully regulators into thinking twice before pursuing recalls in the future.

Aside from suing the F.D.A., the company has threatened legal action against a leading state food-borne disease investigator in Oregon, where the Del Monte cantaloupes were identified as the cause of the salmonella outbreak. And it has challenged some of the basic techniques of food safety investigations, like relying on ill people’s memories of what they ate when microbiological testing does not find pathogens on food.

“This clearly looks like an attempt to intimidate state level investigators,” said Caroline Smith DeWaal, food safety director of the Center for Science in the Public Interest, an advocacy group. “The chilling effect is real, and it could have serious implications for consumers who may be exposed to more tainted products because of delays in announcing the results of these epidemiologic investigations.”

An executive of Del Monte Fresh Produce said that its melons did not make anyone sick and that the purpose of the lawsuit, filed in Federal District Court in Maryland last month, was to improve food safety by pointing out flaws in the way some investigations were handled.

“It’s got to be a comprehensive and reliable investigation, and in our opinion this was neither,” said Dennis Christou, vice president of marketing for Del Monte Fresh Produce, which is based in Coral Gables, Fla. “There’s absolutely no basis in the claim that this was done intentionally to intimidate or bully anyone.”

The company said Wednesday that it was in talks with the F.D.A. to resolve the dispute and expected an agreement soon.

Many in the produce industry, which has been buffeted by recalls for items as diverse as spinach, peppers and papayas, are quietly rooting for the company. “In this particular case, the F.D.A. took on an adversary that has some ability to stand up and say, ‘We’re not going to be treated this way,’ ” said Jim Prevor, editor in chief of Produce Business, a trade magazine.

We were; of course, glad to have an opportunity to speak with Mr. Neuman and to state the case as we saw it.

It was, however, very difficult to get this case — as it is in most food safety cases — to be viewed from any perspective other than that of the legal framework that the food safety community has established over the years.

The New York Times piece really focused on two issues:

First, in the lawsuit directed at the FDA — you can read the complaint here — Del Monte Fresh focused its efforts on establishing that there is no proof that its cantaloupes, at least at the farm, ever had pathogens on them.

Del Monte Fresh had no real alternative to take this approach as the law is very strict if the pathogens were there.

Since it is not contested that Del Monte Fresh’s point — that there has been no tangible evidence as to the existence of the pathogen on Del Monte Fresh produce — is true, this argument basically came down to two separate questions:

A)  Now that we have the capability to identify pathogens through testing and to genetically link those pathogens to those in sick people — is a case defined solely by epidemiology sufficient to impose all the various penalties the law holds for the introduction of pathogens in the food supply?

B)  Even if in some cases a pure epidemiologically driven case is acceptable, is the epidemiology correct in this case and strong enough to draw the conclusions the FDA has drawn?

Second, in its press release, Del Monte Fresh indicated it had filed with Oregon a “notice to sue” both Oregon’s Health Authority’s Public Health division and one of its officials. Mr. Neuman identifies this official as the state’s Senior Epidemiologist, Dr. William E Keene.

The issue raised here is that these lawsuits against Oregon, an individual and the FDA may have a chilling effect on the pronouncements of public health authorities:

“This clearly looks like an attempt to intimidate state level investigators,” said Caroline Smith DeWaal, food safety director of the Center for Science in the Public Interest, an advocacy group. “The chilling effect is real, and it could have serious implications for consumers who may be exposed to more tainted products because of delays in announcing the results of these epidemiologic investigations.”

These issues are actually pretty simple.

When it comes to a “chilling effect,” it seems certain that a knowledge that one could be sued for erroneous statements could lead to more caution before speaking.

The question is whether that is bad or not. We allow journalists freedom of speech, but we encourage responsibility by having libel and slander laws. The public policy goal is, after all, not just to encourage public health authorities to speak, but to have them speak accurately.

As our interview with noted legal authority Richard Epstein pointed out, government officials and agencies do not typically have the same liability for erroneous statements that a private sector actor would have.

The world learned in a very public way from the salmonella Saintpaul outbreak that the FDA can be wrong and that the shattered tomato industry had no place to go to get back its reputation — or its financial losses.

So some push-back from industry, if it gets the public health authorities to be more cautious in making pronouncements without solid evidence, may be a very beneficial thing.

Remember the utility of public health authorities depends crucially on their credibility. If their credibility is higher, more people will listen to them and that would help public health.

When it comes to the issue of epidemiology, it is inevitable that now that we have the ability to do genetic testing, people will be looking for that kind of evidence.

We won’t always have it. The issue here is that if a prosecutor in a court case doesn’t have DNA evidence or fingerprints or a murder weapon, the prosecutor has to not only have a theory but has to be able to convince a jury of his theory.

Mr. Neuman quotes Dr. Michael T. Osterholm, who we interviewed during the salmonella Saintpaul crisis in a piece you can see here, as saying that the epidemiology in this case is solid:

“There’s no doubt the data are very tight,” said Dr. Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Del Monte caused that outbreak.”

And he said that many investigations involving sickness from produce did not find contaminated food because by the time officials became aware of the outbreak, the tainted produce had been eaten or discarded.

We have the highest regard for Dr. Osterholm. He is in a tough spot on this one, as in addition to working for government and now being an academic, he has long been a consultant to Fresh Express, which is now owned by Chiquita and is one of Del Monte Fresh’s biggest competitors. Still, we are 100% convinced that Dr. Osterholm would speak his mind frankly, and so we are certain that he is sincere in his belief that the epidemiology is very strong here.

We are certainly not going to try and parse epidemiological studies with Dr. Osterholm. We do think that whatever the strength of the FDA’s case, it should have to bring it to an independent third party for vetting. Otherwise, the risk of an abuse of power is just too great.

Our bigger issue is that whether the epidemiology is correct or not just shouldn’t be that crucial an issue. We now know that food safety is an episodic thing in produce and that even the best firms can get hit.

The bottom line, thinking only of public health, is this:

If you imagine a line of 11 farms, all drawing from the same river for irrigation and all right next to each other. Ten of these farms meet minimal legal standards to produce and ship. The middle farm is a gold standard operator. It has every certification and every audit. It has the most finicky customers and a culture committed to food safety.

Yet, one day, a bird flies over its fields and does its business. The pathogen is found by the FDA and an import alert is imposed. So now imports from this gold standard farm are blocked. So consumers are left to buy from the 10 minimum-standard farms. The judgment of Costco, Wal-Mart, Safeway, Kroger, Darden, McDonald’s, etc., all count for nothing. The fact that they might prefer to continue to buy from this farm they have carefully vetted is irrelevant.

We have tried to deal with issues such as the appropriate legal standard for food safety claims in our piece in The New Atlantis titled, How to Improve Food Safety.

Whatever the ultimate solution, it should be very clear that the use of episodic food safety outbreaks to ban imports may leave consumers with the sole option of buying from “less safe” operations and is thus inimical to public health.

This is the real issue and we have to find a way to get the FDA and the entire legal structure built up around food safety to address this issue. If we are very lucky the decision of Del Monte Fresh to stand up for itself just might lead to some rethinking by the Government regarding how to approach the sporadic food safety outbreak.

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