The polls are closed on eFoodAlert’s inaugural survey, and your verdict is in. Sincere thanks to everyone who took the time to vote, and especially to those of you who posted your comments on both sides of the issue.

The first question dealt with the suit filed by Del Monte Fresh Produce against FDA, seeking to lift FDA’s Import Alert detention order against cantaloupes from a farm in Guatemala. These cantaloupes were linked epidemiologically to an outbreak of 20 cases of Salmonella Panama illnesses earlier this year.

I asked, “If you were on the jury, what would be your verdict?“

• 79% (57/72) voted in favor of FDA
• 14% (10/72) supported Del Monte Fresh Produce
• 7% (5/72) chose “Don’t know”

The second question went to the heart of an ongoing controversy on what constitutes sufficient evidence to trigger a recall. In this case, the outbreak strain was never recovered from Del Monte’s cantaloupes. Nevertheless, epidemiological and traceback evidence was strong.

I asked, “Should FDA have to find the outbreak bug in a food sample before requesting a recall?”

• 72% (52/72) voted “No”
• 22% (16/72) voted “Yes”
• 6% (4/72) chose “Don’t know”

This outbreak and recall was odd right from the start. The chronology tells the story:

• February 5, 2011: First reported illness onset date. All but 3 of the illnesses developed on or before March 10th.
• March 22, 2011: Del Monte Fresh Produce issues recall notice for cantaloupes sold between March 10th and March 21st in Costco stores in the seven states involved in the outbreak
• April 22, 2011: Last illness reported (onset date between April 5th and April 12th).
• July 15, 2011: FDA issues Import Alert #22-03, “Detention Without Physical Examination of Cantaloupes from Asuncion Mita, Guatemala”

In case you missed it, the cantaloupes that Del Monte Fresh Produce recalled WERE NOT EVEN IN THE COUNTRY during the bulk of the outbreak. In fact, by the time the outbreak was detected, the cantaloupes that were thought to be contaminated with the outbreak strain had passed their expiration date and were no longer available for sale.

I commented on the date discrepancy in my original March 23rd posting on this outbreak. And I had a long conversation on the topic with Dr. William Keene, Senior Epidemiologist with Oregon Public Health, who was instrumental in this outbreak investigation. This is what I found out (and reported in a follow-up article on March 30th):

Costco receives only about 6% of the cantaloupes grown on Del Monte’s Asuncion Mita farm. The rest of the crop is shipped to numerous other wholesalers and retailers – most, but not all, of them in the USA. The farm comprises some 15 cantaloupe fields, which are planted and harvested in series to ensure a continuous supply of melons. The last of the 15 fields to be harvested has been shut down since early March.

I asked Bill Keene about the rationale behind the recall. He said that the situation presented quite a dilemma, both to public health officials and to Del Monte. By the time the outbreak was identified and a probable source determined – which happened rather quickly, thanks to the relative rarity of Salmonella Panama and the Oregon illness cluster – the implicated melons had passed their usable shelf life. There was no point in recalling fruit that was no longer edible.

Why, then, did Del Monte recall the cantaloupes that were sold in Costco stores in several states beginning on March 10th? According to Keene, it was unclear whether the outbreak was a “one-off” problem relating to a small quantity of melons from one portion of a single field or whether it was a continuing situation. Del Monte Fresh Produce, therefore, decided on the recall.

And why was the recall limited to cantaloupes shipped to Costco in seven states? Because, except for the Maryland case, all of the illnesses were clustered within that group of states and were linked to cantaloupes purchased from Costco stores. It did not seem logical to recall the entire remaining production from the Asuncion Mita farm for what appeared to be a limited contamination problem.

This begs the question as to whether the recall was justified at all. Therefore, while I would ordinarily support recalling a food product implicated by epidemiological evidence and traceback investigation, in this specific instance, I do not believe that the Del Monte Fresh Produce recall was appropriate. I was uneasy with the rationale then, and I’m uneasy with it now.

As for the Import Alert, “It’s a puzzlement,” as Yul Brynner sang in “The King and I.” Here’s why:

1. As far as I know, FDA never found Salmonella Panama (or any other Salmonella) in a sample of cantaloupe from the Asuncion Mita farm. If they had, this would have been stated as a justification in the Import Alert.
2. According to the statements made in Del Monte Fresh Produce’s Court Filing, FDA never inspected the Asuncion Mita farm (either before or after the outbreak), and has no direct evidence of breaches of Good Agricultural Practices at that farm. Why would FDA not have inspected the farm that was implicated in this outbreak?
3. Del Monte Fresh Produce arranged for a third-party expert audit of the Asuncion Mita farm and the operations of the packing house that handled the cantaloupes from that farm – Productos Agricolas de Oriente S.A. – in April 2011. If, as the company claims, the operations at the farm and the packing house were such that they “…meet and/or exceed current guidelines required to maintain a high level of food safety and regulatory compliance such that only wholesome food is shipped,” why was an Import Alert imposed, and why has it not been lifted?

I’m not in possession of the full story; only the direct participants know everything that has been going on. Nevertheless, based on the information available to me at this time, I believe that Del Monte Fresh Produce is justified in filing suit against FDA to have the Import Alert set aside.

But, that’s as far as I would go. I do NOT agree with Del Monte Fresh Produce’s plan to file suit against the Oregon Public Health Division and its Senior Epidemiologist, Dr. William Keene. Public health officials must be allowed to use their best professional judgement without fear of litigation or reprisal. Any errors of judgement – and there will be errors – should be on the side of public safety.

On March 30, 2011, I reported on an outbreak of Salmonella Panama that eventually sickened – when all the dust settled – 20 people in 10 states. Twelve victims (out of 16 interviewed) reported eating cantaloupe in the week before they became ill. Eleven of the twelve purchased their cantaloupes from eight different Costco locations.

The melons implicated during the outbreak investigation were supplied to Costco by Del Monte Fresh Produce, and were grown on a single farm in Guatemala. But the outbreak strain never was recovered from the implicated cantaloupes.

By the time the outbreak was detected and the probable source of the infections determined by the federal and state epidemiologists (through patient interviews and product traceback investigations), the implicated cantaloupes had passed their useable shelf life and were no longer on the market. Nevertheless, Del Monte Fresh Produce decided to recall the remaining stock of Guatemalan cantaloupes that it had supplied to Costco in states where outbreak cases has been confirmed.

In addition to the recall action, the FDA issued an Import Alert (#22-03), authorizing its District Offices to “…detain, without physical examination, all raw fresh and raw fresh refrigerated cantaloupes, frozen and processed cantaloupe, including fresh-cut cantaloupe (i.e., sliced/chopped), offered for importation that appear to originate from …” Asuncion Mita, the Guatemalan farm that grew the implicated melons.

At the time of the recall, Del Monte Fresh Produce chose to cooperate with FDA. Now, however, the company has had second thoughts. On August 22, 2011, Del Monte filed a lawsuit against the FDA, claiming that the federal agency had “…imposed harmful restrictions on Del Monte’s importation of cantaloupes from a major source in Guatemala, based upon an erroneous speculative assumption, unsupported by evidence, that cantaloupes previously imported from that source were contaminated with the pathogen Salmonella.” The lawsuit asks the Court to issue “…declaratory judgment holding that FDA’s actions restricting importation are unlawful, set aside the actions, and issue a permanent injunction prohibiting FDA from enforcing or effectuating them in the future.”

And that’s not all. Del Monte also has notified the state of Oregon that the company intends to file suit against the state’s Department of Public Health and its senior epidemiologist, Dr. Bill Keene, who played a major role in the outbreak investigation.

This is the first time that I can remember that a food company has sued FDA over a regulatory decision such as an Import Alert or a recall recommendation. If this case goes forward – even if it is ultimately decided in favor of FDA – I strongly fear that the agency will be more timid in future when faced with potentially controversial recall recommendations.

I know what Del Monte Fresh Produce thinks – that’s clear from their Court filing.

I know what food poisoning attorney and blogger Bill Marler thinks – that’s eminently clear from his blogs on the subject since the lawsuit was filed on August 22nd.

But, I want to know what my readers think. Here’s your chance to have your say. Just answer the two poll questions below, and add any comments you care to in the comments field at the bottom of this post.

I look forward eagerly to reading your replies.