Pundit Interviews

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Perishable Pundit
P.O. Box 810425
Boca Raton FL 33481

Ph: 561-994-1118
Fax: 561-994-1610


email:
info@PerishablePundit.com

a

Produce Business

Deli Business

American Food & Ag Exporter

Cheese Connoisseur



We Are All Affected
By Cantaloupe Issue

We’ve elected to devote this entire issue to the controversy regarding Agropecuaria Montelibano, a Honduran grower and packer, whose cantaloupes are the subject of an “import alert” announced by the FDA.

We started our coverage of this issue with FDA Fumbles Again On Cantaloupe ‘Alert’, and it is no small matter to devote a whole issue to one subject. We realize many people do not deal in cantaloupes or that cantaloupes are only an insignificant part of one’s business.

All we can say is to repeat a story we were told the other day as we received a frantic call from an industry member caught up in this cantaloupe situation. He said, “You know, I read every edition of the Pundit, and love it, but I skimmed a lot of the spinach stuff because we don’t sell spinach. Now I’m wishing I had read every single word.”

We never get the luxury of knowing what we need to know, and we never get the chance to prepare ourselves for unanticipated events.

So the leaders of tomorrow are those who broaden themselves today, who open themselves to learning more than they think they need to know.

The one thing we are certain of is that this saga is not much about cantaloupes or salmonella; it is about business and politics and loyalty and struggle. It is about hope and perseverance. It is about strategy and about tactics. It is about that something in the human spirit Faulkner alluded to when in accepting the Nobel Prize for Literature, he explained his belief:

I believe that man will not merely endure. He will prevail. He is immortal, not because he alone among creatures has an inexhaustible voice, but because he has a soul, a spirit capable of compassion and sacrifice and endurance.

Compassion, sacrifice and endurance. You never know when these traits will come in handy. If you require information beyond what we have included here, please don’t hesitate to let us know.




An Abuse Of Power:
A Portrait Of The FDA As Bully

What is the difference between living as a free man or woman and living under tyranny? The answer is not living without laws and regulations — that is just anarchy. The answer is living under the rule of law.

People are entitled to know, in advance, what is legal and what is not legal; they are entitled to know what the consequences are for various behaviors and to trust that the laws will be uniformly applied to all. The government can take no action against a person for exercising his lawful rights. If a person is punished, he or she is entitled to know when the punishment is over and what is required to get back in the good graces of the law.

It is increasingly evident that the saga of the cantaloupes from Honduras that we addressed in our piece, FDA Fumbles Again On Cantaloupe ‘Alert’, has little to do with food safety and a lot to do with an FDA anxious to be seen as “doing something” in regard to food safety and “being tough” on imported food. So anxious that it is prepared to bend the law to garner the “tough cop” reputation it covets.

It is also clear that the arrogance of the FDA — a feeling that it has no obligation to explain itself or to provide evidence for its decisions or to articulate consistent policies — is undercutting the moral basis of the case for increased funding for the FDA and will eventually undermine consumer faith in the agency and its edicts.

We were, of course, pleased that important consumer media outlets, including “The Lede” from The New York Times, picked up on our point about how odd the FDA’s announcement was. After all, FDA mentioned only a company in Honduras and not any brand that the melons were marketed under.

Of greater concern, though, are seven important issues:

1) The company in Honduras has been very open, and it has explained that in its meetings with the FDA, it was told there were two tracebacks that implicate the company.

The first traceback comes from a casino in Washington State. The implicated delivery, however, contained product from three separate sources — the majority of which were not from Agropecuaria Montelibano.

The second traceback comes from a buffet-style restaurant in Salt Lake City, Utah.

Considering the fragility of memories and the food safety issues of buffet-style restaurants, this seems like pretty thin gruel to stop a whole industry. If the FDA has more than this, it is incumbent on it to present to the public its evidence and make its case. Yet the FDA feels no obligation to prove its case at all. The FDA rules, in the midst of our democracy, as some relic of the divine rights of Kings — “L’État, c’est moi”.

2) The CDC has said that the last report of an illness was made on March 5, 2008. With an incubation period of 12 to 72 hours for salmonella and the FDA having told us that the illnesses reported in accordance with a bell curve that peaked several weeks earlier, what is the basis for believing that there is ANY current health risk? Much less one so substantial as to destroy a company, crush an industry, a country and impoverish countless people. Consumers, after all, can hardly be expected to distinguish between producers or countries of origin; they are more likely to just avoid cantaloupe — or all melons.

3) Spokespeople for the FDA have told us that even if there is no current health risk, they had to issue the “import alert” because until it is determined what caused the last outbreak, consumption must be stopped since we are at risk that it could occur again. Even assuming that the outbreak had something to do with Agropecuaria Montelibano — a “fact” FDA has certainly not established — this is a standard that FDA just made up.

To this day, we do not know the cause of the spinach outbreak of 2006; the causes of most outbreaks are never determined. All these people now get to ship their product.

4) If a restriction is necessary, on what basis is all the product of a company banned? Agropecuaria Montelibano has multiple packing houses and multiple farms. Restrictions, when imposed, are typically imposed against the field, the farm, the packing house that is implicated — not the whole company. Why is this being treated differently?

5) Precisely where does the FDA get the authority to impose “import alerts” that are actually defacto nationwide recalls? The answer is that the FDA lies. It takes these alerts, which are actually binding instructions on FDA personnel, and declares them to be “guidance.” This distinction is crucial: If the alerts were binding, the FDA would have to post proposed rules and get comments on them before adopting them. By declaring them “guidance” when they clearly are not, it just shows contempt of the law and the due process of law that the Constitution requires.

6) There is no domestic counterpart to an “import alert.” FDA personnel at the border can refuse entry to product, but FDA can’t station officers around a domestic cantaloupe farm and prohibit sale of the cantaloupes. This seems very much like a trade barrier prohibited under the WTO.

7) Why is there no communication? The FDA chose to do this with FDA personnel over Easter weekend, when people couldn’t get in touch with lawyers. It was a catastrophe. Executives were traveling. Why behave this way? Why not be decent and call the folks and say this is what is happening, get your ducks in a row, call your executive team back from vacation. Why make the situation more difficult than it has to be? Even better why not put eveything in writing so people won’t have to speculate on what the FDA meant when its staff spoke to them?

As best we can determine, the answer to all these questions is that the FDA is indulging in an irrational absolutism. That it has forgotten it is an agency leashed by the Constitution and that food safety is important, but is not the only interest the Constitution protects.

There has been an ongoing debate about whether the FDA should have the authority, and under what conditions, to order a mandatory recall. In produce, FDA does not have that authority. For good reason… under the law, producers are liable for any harm their product may cause — recall or not.

It is very easy for the FDA, which doesn’t have to pay the bill, to order recalls, justified or not. In fact, since FDA is likely to get blamed for any sickness, but there are zero consequences for the FDA if it orders a recall that was not necessary, we can expect the incentives to lead FDA to order many superfluous recalls.

That is, in any case, a discussion for another day. For now, despite much discussion, Congress has elected not to give the FDA authority to order a mandatory recall.

This means that, under the law, FDA should go and seek a recall. It should have to persuade the importers of record that their product was at fault. It should not use some form of sleight of hand to impose a recall, which it currently has no legal authority to impose.

Yet this seems to be precisely what happened here.

Even though the evidence is marginal at best, the threat infinitesimal and the FDA made no effort to seek a voluntary recall, the FDA just decided to show those Hondurans who the boss is.

Normally if there is a recall, it is narrowly tailored: specific farms, specific production lines, specific brands, and production during a specific time frame, perhaps specific lot numbers.

This time, the FDA didn’t even ask. It made no effort, zero, to find out which packing line, which farm, to do anything to mitigate the impact of its planned alert. The FDA simply decided it wouldn’t respect the importer’s rights not to recall and would force a defacto recall upon them. After all, if the FDA issues a statement saying that consumers ought to “throw away the cantaloupe,” no reputable retailer will stock it.

In effect, instead of respecting the legal rights of the importers, the FDA looked for a way to evade the law and thus usurp a power — to order recalls of fresh produce — that Congress has not elected to grant the FDA.

Under normal circumstances, the FDA would get away with it. Some farmer — not willing or able to fight city hall — would apologize, admit guilt, do anything to get back in the good graces of the FDA so he can start shipping. In fact, in good conscious we have to urge the good people of Honduras to do just that so they can get shipping before the season is over.

It is only because Agropecuaria Montelibano had the ear of the president of Honduras and because produce is such an important industry — and because the FDA without strong cause insulted the integrity of the produce of this proud nation — that the FDA may be pressured to “reexamine the evidence”.

Early in the morning of March 27, several officials from Honduras — The Minister of Agriculture, The Minister of Commerce and The Minister of Health — met with Mr. Michael O. Leavitt, the US Secretary of Health and Human Services, to request an immediate lifting of the FDA’s import alert based on the fact that there is no hard evidence and little in the way of circumstantial evidence to tie this particular farm to this outbreak.

They also surely made the case that with the last illness being identified on March 5, 2008, there is no ongoing threat to the health of the US population.

We hope Secretary Leavitt listened. We know that FDA and CDC personnel are now in Honduras; hopefully a deal will be struck and the “alert” will be lifted. We also hope, though, that when this is over, the Secretary will launch an investigation of how the FDA could behave in a manner so offensive to American ideals of fairness, justice and due process of law.




Emergency Task Force Requested

The Honduran Embassy in Washington, DC, recently hand-delivered a letter written above the signature of Hector Hernandez Amador, Secretary of Agriculture and Livestock and addressed to Michael O. Leavitt, the US Secretary of Health & Human Services.

Demonstrating that this issue is spiraling way beyond a simple FDA matter, the letter was copied to various US officials, including the State Department and the National Security Council.

The Perishable Pundit obtained the full text of the letter which reads as follows:

March 25th, 2008


The Honorable Michael O. Leavitt
Secretary
US Department of Health & Human Services
200 Independence Avenue, SW
Washington DC 20024


Dear Mr. Leavitt:
I am writing to request your immediate action on an issue of the gravest concern to the government of Honduras.

On March 22, 2008 the Food and Drug Administration (FDA) issued an import alert regarding entry of cantaloupe from a single Honduran grower and packer. This was based on the belief that such product may have been associated with a recent outbreak of Salmonella Litchfield in the United States. Since the announcement, joined by representatives of the Honduran government, the company met on March 24 with the Center for Food Safety and Applied Nutrition (CFSAN) staff and provided extensive data regarding its preventive food safety systems.

Unfortunately, this issue has escalated dramatically over the past several days. All Honduran growers and producers of all melons are encountering significant resistance, not just in the United States, but in other markets throughout the world. Most customers are simply refusing to buy any and all Honduran melon products.

This action has precipitated a growing crisis throughout our agricultural sector. We are confronted with potentially devastating losses of jobs and income within a critical sector of our economy, and one which must function within an extremely short growing season.

While we fully respect FDA’s food safety efforts, we strongly believe that this calls for an extraordinary cooperative effort between our respective governments. We would therefore propose the immediate formation of an emergency task force comprised of appropriate experts from both of our governments. Such a group would be charged with:

  • Conducting a full examination of all data of potential health and food safety concern;
  • Conducting an immediate review of all Honduran growing and packing facilities to further insure the adequacy of our food safety system;
  • The resumption of import activity consistent with such reviews; and
  • Appropriate communication to the public

In order to be effective, the work of the team must begin immediately and it must be completed in a matter of days, not weeks. Given the length of our growing season, the alternative is the collapse of the melon industry.

Time is of the essence regarding this request. Please advise at your earliest possible convenience FDA’s willingness to work with us to cooperatively address this critical issue.

Sincerely,

Hector Hernandez Amador

Secretary of Agriculture and Livestock


CC: Ed Schafer, Secretary
US Department of Agriculture

Andrew C. Eschenbach, M.D. Commissioner,
US Food & Drug Administration

Julie Louise Gerberding, M.D., M.P.H., Director,
Center for Disease Control

Daniel S. Sullivan, Assistant Secretary
Bureau of Economics, Energy and
Business Affairs, US Department of State

Daniel Fisk, Sr. Director
for Western Hemisphere Affairs,
National Security Council

Christopher A. Padilla,
U.S. Undersecretary of Commerce
for International Trade

John K Veroneau,
Deputy U.S. Trade Representative

The letter points out that FDA’s actions have led to the collapse of a labor-intensive industry, which has only a short market window in which to function. The letter also points out that we have days, not weeks to resolve this matter if the industry is to be saved.

In calling for an emergency task force to be composed jointly of officials from both countries, Honduras is attempting to elevate the importance of the issue with a goal toward expediting its resolution.

The letter is carefully worded to respect the FDA process, and the purpose of the task force can be read as helping the FDA by expediting the receipt of any information it might need.

There are several dilemmas here. The US will be loath to agree to such a task force because how could the US then refuse China or any other country of the same treatment.

In addition, the Hondurans have to tread delicately. Although they desperately want the import alert lifted, it has to be perceived as being lifted because the FDA is satisfied that the problem is solved. If the import alert is lifted and it is perceived that it was because of diplomatic pressure, consumers will hesitate to buy the Honduran product.

We understand that FDA officials are now on the ground in Honduras. Our suggestions to our friends in Honduras are these:

The only real way out of this is for the Hondurans to allow the FDA to save face. The Hondurans should issue a press release that the Honduran government and Agropecuaria Montelibano have always made food safety the highest priority and that the country is thrilled to have a chance to learn from some of the world-class experts at FDA about some additional ideas on how to put Honduras’ food safety program into overdrive.

Then announce that the growers are using this time period to sanitize packing sheds, doublecheck suppliers and train employees in food safety.

By now the FDA knows it committed a blunder. The outbreak, if it ever had anything to do with cantaloupes from Honduras, was no longer a health threat by the time the “import alert” was announced.

The dilemma for the employees at the FDA is how to get out of the situation without being called up for Congressional testimony.

The official rule is pretty simple even if typically violated bt FDA itself… an alert gets cancelled only after the FDA gets evidence persuading the FDA that future shipments will meet all the legal requirements and any conditions that created the appearance of a violation are changed.

This is a tough one as, of course, nobody in Honduras believes there was a violation — and plenty of Americans doubt it as well.

Yet if the goal is to prove that to the FDA, to make them admit they were wrong, this melon season will be gone and next one rather uncertain.

When the spinach crisis came to the US in the fall of 2006, the produce industry and the FDA had to conduct a similar Kabuki dance. There was a two-step lifting of the recommendation not to eat spinach, which we covered in a piece entitled, Though Not ‘All-Clear’, Consumers Can Eat Spinach Again. The first step was a narrowing of the geography, from a national ban to one just affecting three California counties.

If Agropecuaria Montelibano could demonstrate that shipments now are coming from a different farm or packing house than they did when illnesses were being reported, FDA might soon reduce the scope of the “import alert” to only cover product from a particular farm or packing house.

From there, Honduras has to negotiate what will be the FDA prerequisites for starting shipping again. The initial plan in Salinas went like this:

  • An “industry restart cleaning”, in which all facilities are sanitized.
  • A pre-harvest audit to make sure good agricultural practices are being followed.
  • Monitoring of irrigation facilities and procedures.
  • A review of all soil amendments
  • And, if all this can’t be done or done satisfactorily, pre-harvest spinach testing.

The key is to let the FDA say that something has changed, something will have gotten more rigorous. Then hope that with the other pressure you have applied, the FDA will be looking for a way out.

It is hard for us in America to understand how important an industry such as agriculture can be to a place like Honduras. This letter is an attempt by a small country to have its voice heard. We, as Americans, ought to do our best to listen.




Letters From Warren
And Molina Ask For
Support And Patience

In addition to the public statements, incidents such as this “import alert” regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer, become deeply personal. Growers and receivers with relationships going back decades try desperately to navigate a situation neither controls.

We’ve included public statements from various parties in our pieces, including FDA Fumbles Again On Cantaloupe ‘Alert’, but there are private letters as well, sometimes heartbreaking letters as proud men make a plea.

When the communication is between people in different countries, and the implications of an FDA letter or visit are interpreted differently, you can sometimes read the letters and hear the voices of men standing in different places. The relationships touched by this particular situation are particularly longstanding and deep.

We are fortunate to be able to share with our readers four letters. The first is a letter from Michael Warren of Central American Produce, who we also interview here. In this letter, he honors the request of the Molina family, owners of Agopecuaria Montelibano, to pass on their pleas to customers.

Then we run three successive letters from Miguel Molina, who has reached out, with pride and dignity, to ask for help from customers he has served for so many years:

03/26/2008

Good morning,

The last four days have been very trying. We have been asked by the FDA to comply with a voluntary recall. It was our responsibility to communicate to all our clients the facts. We talked to each of our clients that received fruit in the period specified by the FDA to voluntarily withdraw the fruit and hold this fruit pending the final determination from FDA. Many are holding the fruit and some have begun to destroy it.

This is our moral obligation and we have followed through with it. There has been much pressure from our clients to provide information and guidance. Our clients are also under much pressure as a result of their distribution and the consumer has concerns since the FDA alert went to the press. Many of the clients have reacted differently following requests from customers, taking decision to react as is appropriate for each. We respect this since it is a voluntary recall. We have never received clear guidance in writing, only verbally from the FDA.

Also during this same period of time our friends of 30 years and long time suppliers, the Molina family, owners and operators of Agopecuaria Montelibano in Honduras, has been anguishing and gathered all of their credentials, certifications, testing and as much evidence that the FDA is providing to make a presentation and request to the FDA to consider the facts. They have been meeting in Washington for the last two days and will continue today to convince the FDA to change their position.

I know that their operations in the field and packng houses are state of the art and every penny has been invested year after year to continuously update practices and offer a safe product. They ship throughout the US, Canada, Europe and the UK. Clients have all visited their facilities and fields and have seen the work and sweat that goes along with this commitment.

The Molina family has asked me to pass on the information and argument from their side as they continue talks with the FDA. Please see the attached information below along with the links from the FDA. They have their entire livelihood at stake here that is eroding rapidly. They feel the information the FDA has used to arrive at their decision has no firm basis to point to cantaloupe or their firm. I have only seen what the FDA has been provided in their links and verbal conversations I have had.

It is my understanding the FDA still does not have a positive sample of Salmonella in cantaloupes or from the product of Agropecuaria Montelibano.

Please feel free to visit their website also: www.agrolibano.com.

Michael Warren

***********

San Lorenzo, Valle.

March 25th 2008

Dear All,

We hereby would like to give you an update regarding Mr. Miguel Molinas meeting yesterday with the FDA in Maryland. He was in company of the Honduran Ambassador, Director of SENASA, Director of SENASA for Foodsafe, Minister of commerce, Agrolibano’s three layers, Miguel Jr. and Jenny Molina.

On behalf of the FDA there where 15 people present and via teleconference they had the CDC’s staff and representatives of the American Embassy in Honduras. From the beginning of the meeting, the FDA’s authorities paid attention to all our arguments and they were very surprised of our operations and of the professionalism of our company’s executives in presenting all evidences, certificates, and microbiological analysis results to support our arguments during the meeting.

The FDA’s authorities have not been able to present a single positive salmonella result and they only have two tracebacks, as supportive evidence for their statement. The first goes back to a fruit (fresh-cut) processor in Washington State and the second case goes back to a buffet restaurant chain located in Salt Lake City. For respect to our final clients we prefer not to comment their names.

The trace back system is questionable and weak because it does not provide scientific proof that the contaminated fruit belongs to our company, and it does not certify that cantaloupe melons were the cause of the infection for salmonella.

As we informed you yesterday, we have already received the first results from the FDA which came out negative from a load in California. In addition, today we received 3 analyses with negative results from our main importer in the UK (Mack Multiples), which adds to the 149 negative analyses we had in our records.

In addition, we would like to inform you that the questioned cantaloupe melons were packed in January in Santa Rosa Farm, and currently the majority of the fruit which you and your clients have in your coolers was packed in Montelibano Farm. Rest assured, both farms do not have and have never had a bacteria infection, since as you know clients such as Chiquita and Dole make microbiological analysis at our farms. In addition, your company also performs microbiological analysis on the fruit upon arrival.

Presently we are still packing cantaloupes, honeydews and galia for Holland, Germany and the United Kingdom since all our clients are and will continue to accept and support us since they know Mike’s Melon is not infected.

For the United States, we are not packing cantaloupes but are packing honeydews, since as you know all honeydews are sowed, cultivated, handled, and packed in separate independent farms, such as Palenque farm and Embarcadero farm.

Considering these last points mentioned, we would also like to ask for your same support. Please wait with us for the next 4 days until we receive the remaining microbiological analysis results from the FDA. The process with the FDA might take this whole week, and every day that passes by we are losing a great amount of money.

Our exports to the USA represent 70% of our total sales, so our company is suffering tremendous losses. Therefore, we need the full support from all of you because without it our company would run out of business and more than 5,000 families will be directly affected. This is a hard statement considering that Agrolibano’s team has been dedicated to fulfilling all our customers’ needs since its foundation in 1979.

For this reason, we urgently request that you convince your clients that our melons are not the source of contamination. They should not be stopping the purchase of our white honeydews and galias because these two types of melons are sowed, harvested and packed in different farms. The cantaloupe is being questioned by FDA, but we are completely sure that the image of cantaloupe from our company will be completely cleaned once FDA releases the rest of the results.

We are aware that during the past some of your providers, which are very professional companies, have had incidents of positive salmonella and have received the full support from you. Our situation is less serious since we have not had positive salmonella. However, an intensive media communication on the alert from the FDA, who issued the alert with no proofs, is killing us!

We know for a fact that FDA is putting tremendous pressure over you and your clients (supermarkets, wholesalers, processors, food service customers, etc.) through phone calls and personal visit , but not in written form because yesterday, during the meeting, they clearly said that the recall was voluntary.

The FDA’s staff is being very aggressive on this matter, even making personal visits to our clients’ warehouses in order to make sure that the recall is done and that your company makes a public announcement. We believe the FDA is using this method just to relieve itself from responsibility and pass it on to you, your customers, or third parties because it does not have evidence that our melons are contaminated. Therefore, we urgently request your support us by:

  • Not making a public announcement
  • Stop the recall until we have a final confirmation this week

We hope that the FDA will change their first statement and consequently release all fruit and containers that are on hold.

We look forward to your prompt confirmation. From our side, we will keep you updated.

Best regards,

MIGUEL MOLINA

***********

Tuesday, March 25, 2008
11:15 PM

Dear and Loyal Costumers:

In the name of my family and all Agrolibano employees, we want to thank you for your support. There has been a lot going on, and we are doing our best to clean our reputation and convince the FDA to retract, but this is not an easy task. We are working with great lawyers and have full support from our government.

Today our president gave an interview on CNN and he ate one of our melons on it. As you can see our side of the story is slowly taking the media attention. CNN was also in our farm today.

We are completely sure that we did not create this problem. So far, we have 145 clean results of cantaloupes packed from December 22, 2007, thru March 25, 2008, two of these results are from shipments that FDA tested. As we mentioned on our previous update, the FDA did not have any positive results from our melons. All their argument is based only on the two trace backs that we mention in our public statement.

As you are aware, our business has been ruined. Not only the cantaloupes have been affected but also the honeydew and even our European costumers have big difficulties selling not just the cantaloupes but also the galias. They are making their own tests in order to convince the supermarket that the melons are free from any contamination. By the end of this deal our melons will be the most tested in history.

The FDA has our hands tight. They wrote the import alert in a particular way: our cantaloupes can not be lab-tested, they must be destroyed or returned to Honduras. Besides they have continued visiting you personally, asking you to make press releases about making voluntary recalls. This takes the pressure out of their hands and passes it to you. So far, only one of you has done it. Please do not play their game .Give us a little bit more time.

We are already talking to the shipping lines asking for their support to help us and keep the containers at the port during this week. If this does not get resolved by Monday, we will start making arrangement to return them back. Also we will discuss with every one of you on what will be the best solution with the fruit you have in your coolers.

We deeply appreciate your support and loyalty.

Miguel Molina

***********

Wednesday, March 26, 2008 4:50 PM

Please see this last article from the New York Times:

http://thelede.blogs.nytimes.com/2008/03/26/
honduras-fights-us-ban-on-its-cantaloupes/index.html ex=1364270400&en=0d26a5fdd290d368&ei=
5088&partner=rssnyt&emc=rss

The advancements today have been great. Tomorrow the first officer from the FDA is traveling to Honduras, and the rest of the commission will come on Friday. If everything is found to their satisfaction, they will lift the import alert directly from Honduras.

On the other hand, tomorrow [March 27] at 8:30 am, the Honduras minister of agriculture, minister of commerce and minister of health is meeting with Mr. Michael O. Leavitt US Secretary of Health and Human Services. The request will be to lift the alert prior to the visit based on the fact that they do not have any positive sample.

Also I would like to give you some more specific update about the two trace backs we are implicated with:

  • The first happened in a casino in Washington. We have information that the specific delivery implicated had fruit from three different sources. The majority of the fruit was from other sources. Only 80 cases where actually ours.
  • The second case happened in a buffet restaurant in Salt Lake City, Utah

It is really difficult to believe how such a big organization with so much credibility can make a decision based on this information.

Things are moving really fast, we will keep you posted.

Again, thank very much for your support and loyalty.

Best regards

Miguel

We cannot imagine it is easy for a man like Miguel Molina to plead with customers for patience and support. We fear that he may be too optimistic, not realizing how difficult a giant bureaucracy as the US government can actually be. We wonder if he recognizes that in most cases, his customers have lost control — that the situation is now being handled by legal at a big supermarket chain, and nobody who knows him or his importers will be able to do much to help.

The FDA steamroller having rolled, importers now have had to listen to their own lawyers and do their own recalls. Perhaps Miguel Molina will feel betrayed. We hope not. Everyone who knows him and his family holds them in high esteem; not a bad word has been so much as whispered to us. It is just that the FDA has many ways of making everyone fear for their future.

We think if we can get past this juncture, start business up again, we will find a way. We suspect it will be easier to get some aid for Honduras than to get the FDA to admit it was wrong.

There are a lot of important facts in these letters. We hope they play a role in persuading the powers that be to do the right thing. But, beyond the specifics, there is something ennobling in these letters, a notion that men are not meat — the more you pound them, the tougher they will get. A notion that relationships matter and that it is reasonable to think those who have done right may be treated justly.

And these letters were not written by lawyers or committees. They were written by men, during very difficult times. And there is something in them that makes one very proud to be part of this industry.

Our prayers are always with those threatened with injustice.




FDA Responds To
Cantaloupe ‘Alert’ Questions

We wanted to better understand what the FDA was doing with this “import alert” that implicated cantaoupe produced by Agropecuaria Montelibano. To do this, we asked Pundit Investigator and Special Projects Editor Mira Slott to show the FDA the statement issued by the grower and try and get a reaction:

Sebastian Cianci, FDA spokesperson

Q: How did FDA come to the conclusion that the cantaloupe outbreak is linked to this particular Honduran grower Agropecuaria Montelibano?

A: This is an on-going investigation. It appears this firm is a common source. We’re not saying it’s not possible to find another source. We’re not saying we’ll find the exact cause of the outbreak.

This doesn’t mean the firm isn’t taking preventive food safety measures, but sometimes a problem occurs anyway. A flag came up in the system and we need to investigate.

Q: Could you describe the steps in the investigation that led to the link with this grower?

A: What we do for the trace back, we often have a lot of people who report illnesses. Individuals have varying memories of what they ate and where they purchased it. We look at cases where we have good strong reporting information; good memory on the part of the individuals on what they ate and where they purchased it; then we go back and look at the points of purchase and see who has good records there.

We’re trying to hone in on where evidence seems to be strongest. Through CDC’s epidemiological work, a common source was this Honduran firm. We worked closely with CDC. We examined purchase records of consumers, and then who the suppliers were, tracing back through the supply chain to point of origin. The Honduran firm came up as a common source.

This has proven to be a highly effective way to determine sources of food borne contamination. The case is still going on so if something else pops up, we’ll pursue that too. Trace back is tough, but right now based on the records, this looks to be a common source.

Q: Has FDA conducted tests on the grower’s products and discovered a positive sample result confirming a match to the Salmonella strain in the outbreak?

A: This happens in outbreak after outbreak. Let’s go in and start sampling product; sometimes it takes a long time. But you have 50-some people sick with the exact same strain and only have one common product. So even though we haven’t pulled up a positive test result — all evidence points to this firm

Let’s suppose 20 of those people provide uncertain information, that still leaves 30. I don’t know how many cases we based our trace back off of, but I do know CDC determined that its epidemiological analysis was sufficient to show a common thread. I can’t address the two cases referenced by the Honduran firm.

I don’t know where that number came from. It took a long time to get to this point in our investigation. CDC gets reports over an extended period of time. They might get reports of illnesses for a while before they realize there is a pattern and outbreak.

Q: What is the pattern of this particular outbreak? Could you review the dates of when it started and how long it has continued? Since you just issued the alert on March 22, does this mean you believe the outbreak is still in progress?

A: Most illnesses occurred in late January and early February. It is not clear if the problem has passed; there were still illnesses being reported recently. The reporting of illnesses looks like a bell curve; a few early in January, a bunch at the end of January, a bunch beginning of February, and still a couple occurring beginning of March.

It’s not clear if we’re on the tail end or if it spiked; this may be an on-going outbreak. It has been tapering off, but nonetheless, it takes time for these incidents to come in. The outbreak has covered a range from January 18 through March 5 in the U.S. I’m not sure if there was a different time frame for Canada. Irrespective if anything comes up with any other firm, it appears for now this Honduran firm appears to be the source.

Q: It sounds like there is still much speculation involved?

A: Especially if we think this may be continuing, we need to advise a recall. If it’s still continuing, we can prevent people from getting sick, but for trace back if we can get an idea of the conditions of how it occurred, we can come up with better practices for the whole industry.

Many things can happen that impact food safety; it could be related to the proximity of animals to field, or a change in processing techniques that introduces a different risk. Something has never been a problem and now there’s a mutation or something that allows a pathogen to grow… because we’re in a dynamic, changing environment, we need to investigate.

We’ve narrowed the problem to the firm, but not to a field. In the course of the investigation, we may find other commonalities, maybe it’s a processing line, for example.

Q: Do you acknowledge that you may never actually determine the cause? After all, there is still uncertainty to the origin of the spinach E. coli crisis.

A: We can pair up similar illnesses and through DNA sampling determine if they’re the same strain. We can look at shipping records and see this firm came up as a common source, but we don’t know how the Salmonella got there; did it happen on the farm, or part way through the supply chain? Was it in irrigation water, on someone’s hands, does product go through a chlorine bath, is there something on a piece of equipment not sanitized? That can be very difficult to find out. In a lot of cases we can’t find out.

By the time it goes through the supply chain, the information can be lost.

Q: The grower says that FDA is holding product samples that are in the process of examination. In addition it says it has performed extensive salmonella analyses by independent certified laboratories on product samples covering December through March timeframes, as well as analyses of packing house water, irrigation water, land, packing personal, and results of all have been negative.

A: We are working with the firm and the Honduran government. FDA has collected samples coming through as imports from their farm, not taken directly from their farm, and we are currently testing them.

Food safety programs are comprehensive programs; they involve preventive measures and testing. We really like preventive measures because you can do end product testing and still not find something which is there. As a stand-alone, testing doesn’t work.

It may be very difficult to eliminate all possibility of contamination whatsoever; these aren’t sterile products, they grow on the ground. You take preventive measures to alleviate the chance someone gets sick the best you can. You can do everything right and something can slip through.

Q: When did you get the grower samples you are now testing?

A: Before we were able to narrow down the problem, we knew something was going on with melons; in that process, we did begin sampling more imported cantaloupes so we do have samples from that firm. If you have very low levels of contamination, you can pull a sample size and not get one of the offending products. Let’s say hypothetically for every thousand that go through you grab 25 and test. But once it’s spread across 40 million people the problem starts showing up.

The fact something doesn’t show up in testing by itself doesn’t guarantee it is problem-free, which doesn’t say you shouldn’t do extensive testing, but it’s not fool proof.

Q: Could you clarify FDA’s role in issuing alerts and recall notices?

A: We’re contacting importers and encouraging them to recall this grower’s product. FDA can’t force a recall; it’s not in our regulatory authority. We can’t mandate a recall.

There were 50 illnesses in the U.S. and nine in Canada between January 18 and March 5. In doing epidemiological work on this, we believe we’ve traced the problem to this one firm, Agropecuaria Montelibano, in Honduras. We issued an import alert, which notifies people who work in the field for FDA if a shipment from this company comes through, we should detain it so it doesn’t come into the marketplace.

We are taking action to stem the flow. We are contacting importers to let them know we’ve put out this import alert, and we are advising U.S. grocers, foodservice operators, and produce processors to remove from their stock any cantaloupes from this company.

If they have any product out there from this grower, we feel they should withhold it from the market. It’s certainly FDA’s advice that this be pulled so consumer can’t purchase it. A company would have to think about whether they want to sell product knowing the risk that it could potentially make someone sick.

If consumers aren’t sure where the product came from, they should check back at the point of purchase and see if the cantaloupe is OK.

Q: In your press alert, your warning says to remove product from Agropecuaria Montelibano, yet the great majority of people have never even heard of this company. How would they be able to identify if their product came from this grower?

A: For grocers, food service operators and produce processors, they should have a mechanism to check with suppliers and determine if the product they are receiving came from that company and pull whatever they have on their shelf. That would remove consumers from future risk.

Q: What if a consumer already has the product at home?

A: A lot of these fruits don’t have stickers identifying origin. There may be a sign saying cantaloupe from U.S, or Honduras at the store, but consumers may not pay attention to that. If consumers have recently bought cantaloupe, they should call the supermarket. The produce manager should know the information or where to find out the information. The larger retailers are very familiar with dealing with these situations.

It’s tough for consumers because typically no label is stamped on it. When we write a press release, we don’t want to implicate other growers in Honduras; we don’t want to implicate a whole country, but from a consumer standpoint, often it’s just cantaloupe.

Q: Why not specify what brand names are affected since consumers would have no knowledge of the grower mentioned in the alert?

A: We’re still trying to find out what the brand names are. We’re trying to get that information now. As of Friday [March 21], we didn’t have any brand information.

I imagine the product in question is marketed under many different brands. Suppose a dozen importers brought in product from this grower. If we can get a pretty comprehensive list, we most likely would put together an additional press release. If we could offer significant information to consumers to help them determine whether they purchased or ate this product, we would.

Right now, we’re in an on-going investigation. All data so far seems to be pointing to Honduras and that particular grower. I specifically checked with our outbreak group, and we think it’s just cantaloupe. Some early reports indicated that some had eaten fruit salads with cantaloupe and honeydew, and it took time to assess. Sometimes people do get sick from similar product, but it’s not related to the outbreak. It’s possible maybe someone had similar symptoms.

This is information FDA learned about through CDC. If you go to www.cdc.gov/salmonella/litchfield/ it describes the investigation. CDC tracks the food borne illnesses. Once they have it narrowed to a certain product, they alert FDA, or if its USDA product, it would alert USDA.

CDC was able to narrow it down to melons but didn’t know which melons, but as CDC did more epidemiological testing, they knew it was cantaloupes. Then we could start to look at where these illnesses were. CDC tracks illnesses and identifies product. And then we try to find the root cause.

Q: From a scientific perspective, are there ways to narrow down the likely causes of Salmonella contamination in cantaloupes and ways to prevent it from spreading?

A: We do advise consumers to wash the outside of whole melons before cutting them.

It’s not clear, but hopefully that will reduce some of the risk. Bacteria could be dragged from the outside to the inside during the cutting process. There is some research suggesting that perhaps salmonella can penetrate the surface and become internalized. In this case, I do not think that washing melon will keep you from getting sick.

There have been some studies utilizing dyes to examine this phenomenon, where melons going through bath to rinse and then cut open showed dye inside absorbed from the surface. If you were doing fresh cut, that could present additional risk. Some that reported illness had eaten fresh cut, but I’m not sure if product was manufactured, done at the supermarket, or at home. That’s why the investigation is complex.

It may be that this number of people getting sick is not new. We’re just better at connecting the dots now and assessing that the outbreak is all from one grower. Now with DNA fingerprinting, we can match up the same outbreak and pathogen that has been making people sick. It’s not necessarily that there are more outbreaks. We have a changing dynamic industry and there are a lot of unknowns. If we have additional information we feel would be helpful in further identifying product, we will share it.

We have been in contact with the Honduran government and the firm regarding the incident. We will be working closely with them to share information and trace back to hopefully determine the cause; it’s often difficult, but we like to try. And also better understand the scope of distribution.

We know where cases popped up, but we may find this product was distributed to other states as well. FDA and the firm want to move past this as quickly as possible.

The problem with speaking to the FDA is not so much that they are wrong as that they are unprincipled.

  1. For example, the last person who was reported ill with this strain of Salmonella was March 5, 2008. Since the incubation period for salmonella is about three days — this would imply the outbreak is over. Instead we are told, “It is not clear if the problem has passed.” But when would it be clear? In thirty days? Forty? Fifty? The FDA won’t say. And next outbreak it will have a different standard.
  2. How many ‘good memories” are required before the FDA shuts down a company? Why is this a secret? Why don’t they publish exactly how they have linked this company? Then we could critique it and see if they are wrong. In other words, a restaurant might claim it bought cantaloupes from Vendor #1 because that is its main vendor who it pays with a check. It might not want to mention Vendor #2 that it pays in cash because it isn’t declaring all the cash it takes in at the register and wants to reduce its volume of purchases or it would be suspicious. By declaring the source, others who know of the true situation might come forward.
  3. The inability to identify brands is inexplicable. It took the Pundit maybe five phone calls to identify four brands. The FDA still hasn’t updated its import alert to be useful to consumers.
  4. The notion that very many retailers are good at these situations is a joke. And it has nothing to do with size. Go to a Wal-Mart supercenter at 3:00 AM and ask a store clerk who grew the cantaloupe you bought last Tuesday. If he answers, would you believe him? Wager your life on a clerk’s answer? The FDA philosophy seems to be to create panic so the shelves are cleared. Millions of dollars thrown in the garbage.

The odds of any danger in all the cantaloupes being dumped right now is so slight, it is certainly a shame and maybe a sin to waste so much healthy food.

There is a kind of disconnect between the risks that FDA is addressing and the costs of its solution. Something is really out of kilter. An absolutism that is leading to unnecessary waste and damage.

Maybe without cantaloupe to eat, people will eat more chicken and some of that will be undercooked, so they will get Salmonella and get sick. There seems to be no place in the FDA’s thought process for comparative risk.

We appreciate very much Sebastian Cianci’s willingness to share the FDA’s position with the industry.




Honduras Cantaloupe Grower:
Model Of Transparency

Agropecuaria Montelibano, the company that has gotten caught up in the “import alert” related to cantaloupe from Honduras, has been a model of transparency throughout this difficult situation. They have made many documents available. Some are only in Spanish and some are in English and some in both.

In order to both assist those interested in further research in the area and to serve as an example for other companies to emulate, we are making available a large selection of this information:

  1. Certificate PLc-13-5
  2. Cantaloupe Microbiological Analysis At Origin
  3. Cantaloupe Microbiological Analysis At Destination
  4. Workers Hand Microbiological Analysis
  5. Packing Plant Water Microbiological Analysis
  6. Irrigation Water Microbiological Analysis
  7. Third Party Certificates
  8. Honduran Government Official Visit
  9. Microbiology Laboratory-UK
  10. Microbiology Laboratory-UK-1
  11. Microbiology Laboratory-UK-2
  12. Ready Pac Finished Product Request
  13. FDA Update
  14. Actualization
  15. Chiquita Email
  16. J.O. Sims Letter
  17. Mensage-Hispafruit
  18. Movie Clip
  19. Nondudiario
  20. Mas Noticias
  21. Chiquita Sample
  22. FDA Fumbles Cantaloupe Alert
  23. Honduran President Eats Melons on TV
  24. Honduran’s Want Compensation
  25. Laprensa
  26. Cadena Global
  27. Gobierno Hondureno
  28. Yahoo News
  29. Associated Press
  30. Bounty Fresh Samples Are Negative
  31. Cargo Release
  32. Inspection Sensas
  33. Leavitt Letter
  34. Packing House Visit
  35. Public Statement
  36. Information 15-08
  37. Results 25-08
  38. JP Fresh Scientific Analysis




Central American’s Warren
Speaks Out About Cantaloupe ‘Alert’

Produce is very much a relationship business, and one effect when FDA issues an “import alert” such as it did on cantaloupe produced by Agropecuaria Montelibano is that it puts these relationships under tremendous strain.

One of the long established and largest importing families has a relationship with Agropecuaria Montelibano. We wanted to see how the Warren family was holding up under this difficult situation. We asked Pundit Investigator and Special Projects Editor Mira Slott to speak with Michael Warren:

Michael Warren, President, Central American Produce, Pompano Beach, Florida

Q: How has your company been dealing with the cantaloupe outbreak?

A: It’s been a little crazy. FDA issued an alert asking for a voluntary recall of cantaloupe melons by this one grower based in San Lorenzo, Honduras.

FDA told us on the phone to use certain dates as the guide — for importers, product dated back from March 1 to the present, and for food processors, from February 20 to present. It also put this grower on automatic detention.

We as a company are definitely concerned for the health and welfare of consumers so we are complying with the voluntary recall. But there haven’t been any confirmed results of salmonella in the melons of this company to date. FDA has no positive results reported from any testing, including recent testing linked to this company to my knowledge.

I wish the FDA or CDC could explain better. I had a conversation with an FDA agent who explained it like this: People back in January and early February were getting sick and went to their doctors and were diagnosed with Salmonella. So when CDC starting getting reports of an increase in Salmonella they started investigating the sicknesses.

And from their interviewing techniques and DNA testing — they have some sort of epidemiological method — they concluded it was from a common strain of salmonella and a common enzyme. It can be in the system two or three weeks before it shows up from what they told me, so then they start with questions and answers — what caused this illness, where were they eating the last few weeks… and their process narrowed the problem down to cantaloupe.

I don’t understand how they can determine that the problem came from this one grower in Honduras. That is still mysterious. I have a hard time with that.

There’s still a lot to be shown on how they determined it was this particular product and this grower. Meanwhile it’s affecting the whole industry. There’s a panic in the industry over cantaloupes now. The warnings are everywhere you look in the media. It’s a voluntary recall, it’s a preventive measure and naturally we’re complying with it.

FDA put out a release for consumers. We don’t know what brand it is. There have been no confirmed illnesses with any particular brand. We don’t know how FDA came up with this one Honduras grower. There’s no importer that’s been named. There are a number of importers from this grower.

We know the grower. We handle some of his product, mostly for program business. But we have product coming in from other farms and other countries as well. I can understand initially consumers are probably concerned and everyone has to take the proper precautions. We’re expecting it will quiet down in the next few days. Produce is safe. And we in the industry realize we have a safe produce supply chain. All of us are following strict guidelines.

Q: What is your relationship with Agropecuaria Montelibano? Can you vouch for the grower’s reputation?

A: We’ve had a long term relationship with this grower, who ships to Europe, England and the U.S. and has the strictest controls and all the certifications and is continually testing and monitoring his products. The company’s public statement regarding this incident gives a comprehensive picture of its practices and how they’ve been wronged.

I think the FDA should define a little more how they’ve drawn this conclusion about these illnesses traced back to Agropecuaria Montelibano. There were no confirmed tests, no clear evidence from their investigations. Meanwhile, the FDA’s actions are playing havoc in the industry.

This grower is very reputable, professional and very conscious of food safety. Our company, as well as other companies, has melons that aren’t involved in this recall and these include melons from Honduras as well as other countries. We didn’t have that much product from this grower on shelves.

Q: Dole and Chiquita both have specified they are not doing a “recall” but rather a “withdrawal” of product. I’ve learned from an FDA spokesperson there are distinct definitions on actions a company can pursue during an outbreak or in the hopes of preventing one.

A: FDA told us this was a Class 1 Recall and we wanted to abide by FDA’s recommendation. We weren’t aware of these word distinctions.

Q: Why does your recall notice on the FDA website stay so general and not define product lot numbers and dates, product shipped between this date and that date, etc?

A: It’s not an official recall notice; it’s a press release the FDA requested us to put out for a voluntary nationwide recall. We sent a draft to them a few times for them to OK the information and insure it was correct. We kept the wording general because we didn’t want it to be lengthy; we had advice of FDA and legal council. All we’re doing is a voluntary recall.

It’s a perishable item, so it’s what’s available and that’s what can be withdrawn. In our letters to clients, we gave them a period of time — any entries into the U.S. from March 1 to present, and in the case of a processor, an entry of February 20 to present. We told them this verbally, and then provided them with the order information, dates, quantities, PO numbers, whatever information was pertinent with their shipments in that date range.

Q: Why is FDA targeting the entire Honduras company and not specific fields or packinghouses related to the products in question?

A: When the FDA came to visit me, they had four different addresses listed for the company. FDA says it has to take a broad approach because it doesn’t have the information on where the problem originated. Somehow from consumers telling CDC where they had purchased product, an investigation took place and it came back to this grower as a common source.

Q: Did CDC or FDA contact you during this process of discovery as a supplier to this grower?

A: Just last Friday, when FDA sent a field agent to our company and sat down with me to explain the situation.

Q: What is the rule now for bringing in new product from this grower? Do you need permission from the FDA?

A: Right now, they are on an alert — detention without physical examination.

The grower is not packing or shipping cantaloupe, but there are some on the waters. There are certain companies that have arrivals; the FDA is taking samples and testing these products. The tests will involve 15 samples per container of product. I don’t know what happens when they get the results. Once those results come back negative, the FDA is not saying the product can be distributed. There is no clear direction on this.

Q: So the Honduras grower and its business partners are left in limbo?

A: We received another letter from my shipper that is ripping my heart out right now; asking all distributors to hold off on destroying product, saying it’s had more than 149 negative tests, and that this is a voluntary recall. The grower is pleading for its customers to stand by them.

Ours is a 30-year relationship of seeing their dedication and investment and commitment to food safety. The grower asked if I could give this letter to my customers. I already sent out a letter to the trade about our melons in Guatemala, and letters telling them of our voluntary recall. And we’ve posted our voluntary recall notice on the FDA website

It’s too late. Each company is taking direction from some corporate leader or entity in their company. I can tell them what’s going on, but in the end it’s the decision of each one of these companies. I need to respect each of my client’s decisions.

There are four things of special note here:

1) Most companies are simply at a loss as to what to do in these situations. The FDA shows up without a notice; few companies have the expertise to challenge the FDA as to whether this is actually a Class I Recall or should be classified as a Market Withdrawal and so they just do what they are told.

This might be a place for the trade associations to step in. Why not make a deal with association counsel to be available for emergency consultations on FDA matters? What a great benefit of giving an association member a free consultation with lawyers who know FDA when you really need it?

2) This business of the FDA walking around dumbfounded without addresses, etc., is bizarre. It took the Pundit less than two minutes to find addresses, websites, e-mails and phone numbers.

This is a very important organization in Honduras. The notion that the FDA couldn’t talk to them immediately strains credulity. You don’t need sophisticated traceback systems to know which packing house and which farm the product came from. If the restaurant is the source implicated by a consumer, you go back to the distributor, who bought it, probably, from the importer, who has a van number from the exporter. That van number should quickly give them the packing house and the farm. What efforts did FDA make to limit the scope of this “import alert”?

3) Although Michael Warren did everything he was told to do by FDA, it is clear that he is more than a little skeptical. Why shouldn’t he be? The FDA has presented no evidence. There is a certain arrogance in the way FDA operates that has to be dealt with.

They should have to make a public case. Otherwise, how do we know someone at FDA isn’t mistaken? Or being paid off by someone’s competitors? A secure organization would make public its information so that it could be scrutinized.

4) The shipper sends a letter that is “ripping my heart out right now,” and out of respect and loyalty for a “30-year relationship of seeing their dedication and investment and commitment to food safety,” Michael sends it on. But he sees the train has left the station. Nobody is listening. The FDA has spoken and that means liability, and that is the end of the story. As Michael says: “It’s too late.”

And what, precisely, has been accomplished that justified this? In fact, isn’t the message the FDA is sending that it doesn’t matter at all how well respected you are? It doesn’t matter who will vouch for you. It doesn’t matter how many certifications you have. How many customers have vetted you.

Isn’t the FDA’s real message that nothing you do will matter? And is that the message likely to increase food safety efforts? It’s ripping our hearts out too.

Many thanks to Michael and Central American Produce for taking the time to speak with the industry at such a difficult moment.




FDA’s Strong Arm Tactics

Although most of the melons subject to the “import alert” regarding cantaloupes produced by Agropecuaria Montelibano are on the east coast and in the Midwest, the product is everywhere.

Another recall was announced by a Los Angeles firm that is a subsidiary of Productos Agricolas Del Campo of Costa Rica:

TROPIFRESH, INC. RECALLS WHOLE CANTALOUPE PRODUCTS
BECAUSE OF POSSIBLE HEALTH RISK

Los Angeles, CA — March 26, 2008 — Tropifresh, Inc. of Los Angeles, CA, is recalling Agrolibano’s Produce Brand whole Cantaloupes because they appear to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Whole cantaloupe fruits subject to this recall carry a “Mike’s Melons” sticker or may be unlabeled because this sticker has fallen off. Whole cantaloupes fruits subject to this recall were sold in approximately 1100 pound cardboard bin containers and were distributed to wholesalers in Southern California, Pennsylvania and Canada.

No illnesses have been reported to Tropifresh, Inc. to date.

These cantaloupe products were supplied from Agropecuaria Montelibano, a Honduran grower and packer, to Tropifresh. This recall was initiated when the U.S. Food and Drug Administration issued an import alert regarding cantaloupe from this grower, because, based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.

Consumers who have purchased these products are urged to return them to the place of purchase. Customers with questions may contact Luis Alvarado of Tropifresh, Inc.

We were told that the key executives from Tropifresh were out of the country. We did, however get a play by play from someone very close to the situation:

Last Friday some lady from the FDA department came into the [office] and gave the company a notice. She said the company had to provide a voluntary recall letter to its customers because of potential contamination with salmonella. Everyone at the company was in shock. The key executives weren’t even in the country.

Once reached out of the country, the executives told the LA-based employees to be helpful. The FDA lady explained the reports of illness. She asked if the company had any of this grower’s cantaloupes in its warehouse, and she was told no, as the company basically drop-ships everything. Whatever comes in goes directly to the customers — mostly distributors or wholesalers, and they sell to mainly retailers.

The company only deals in whole melons. Nobody at the office would even see the product. It goes from the port directly to customers.

Right now the company has been getting melons from Honduras; it is believed just this one grower. The people at the company believe the grower is reputable, it has labs and testing is done often. There’s nothing certain yet from FDA saying, definitively, cantaloupes from this company are contaminated. It’s just an assumption.

When media gets involved, they blow it out of proportion, it’s good to warn the public.

I’m the public, I want to know, but I want the information to be accurate, not an assumption.

This will hurt the industry. It’s a big program now, January through April/May. It’s the season for cantaloupes and honeydew. People become cautious. If I have pink roses with a bug and want to sell white roses, the customer says no to all my flowers.

The Honduras provider is saying their cantaloupe is being questioned by FDA, but the FDA is not sure if it’s contaminated. Our vendor doesn’t want anyone to get worried.

The most interesting point here is this line: “Last Friday some lady from the FDA department came into the [office] and gave the company a notice. She said the company had to provide a voluntary recall letter to its customers because of potential contamination with salmonella.”

This is the way the FDA is functioning — as if it has the authority to order recalls. That is a power Congress has not elected to give the FDA. But in company after company, we hear the situation being presented as “an offer you can’t refuse.” There is something quite wrong with this.

Maybe FDA should insist its people tape record their meetings, so there can be no question that they are not presenting things as if they are mandatory, when they are not.




Why The Delay?

One of the questions the FDA never answers is why it is so slow at getting information out. For example, T.M. Kovacevich in Philadelphia issued its own voluntary recall on March 25, 2008, and submitted its press release to the FDA at that time. Yet the FDA didn’t distribute it until March 27, 2008. Fortunately the outbreak was over before any of this — otherwise these delays, which we have found to be customary, might endanger people’s lives.

In any case, the release read as follows:

T.M. KOVACEVICH INTERNATIONAL, INC.
RECALLS CANTALOUPE BECAUSE OF POSSIBLE HEALTH RISK

Philadelphia, PA — March 25, 2008 — T.M. Kovacevich International, Inc. of Philadelphia, PA is recalling cantaloupes which it purchased from Agropecuaria Montelibano, a Honduran grower and packer, because the U.S. Food and Drug Administration (“FDA”) has determined, based on current information, that cantaloupe fruit from this company has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled product was distributed to wholesalers and processors in Georgia, Florida, Massachusetts and New Jersey, and may have reached consumers through grocery stores, restaurants, or other similar channels. Whole cantaloupe fruits subject to this recall carry a “Mike’s Melons” sticker or may be unlabeled because this sticker has fallen off. Whole cantaloupe fruits subject to this recall were sold in boxes marked with the following text: “Cantaloupe, Mike’s Melons, Produce of Honduras, Grown, Packed and Shipped by Agropecuaria Montelibano, San Lorenzo, Valle, Honduras”.

We are unaware to date of any illnesses that may be associated with any cantaloupes sold by our company.

This recall has been initiated based on the FDA’s determination, based on current information, that cantaloupe fruit from the referenced grower/packer appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.

Consumers who have recently bought whole cantaloupes from this specific grower and packer should destroy these products immediately. Consumers with questions may contact George Manos of T.M. Kovacevich International, Inc.

We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

George ManosGeorge Manos
President
T.M. Kovacevich International
Philadelphia, PA

Q: How has your company been affected by the cantaloupe outbreak?

A: Our experience is a mirror of what happened to Michael Warren of Central American Produce. As developments unfolded over the weekend, we recognized this was a voluntary recall, and having never been associated with one, the learning curve was big. The large suppliers are well-versed in this but we’re in our infancy.

We retained legal council that had discussions with the FDA person in charge of recalls and elected to do the press release.

From our perspective, we were trying to comply with FDA. There is the health issue out there and that is obviously our biggest concern. We don’t know what to make of the situation. Our energy has been focused on getting product back and in a segregated area, and getting word out to our customers.

FDA called me up Friday afternoon. I called the Molina’s (family owners of Agropecuaria Montelibano) and asked about it. It was Easter weekend. There are many FDA field offices. I had to get hold of the office in Pennsylvania. We contacted FDA in Philadelphia on Monday, March 24. Our counsel was getting together with FDA, complying with the voluntary recall and structuring the press release, and on Tuesday our recall release went out. I was more focused on getting product back and sending letters out to all our customers.

Q: Your release specifies the whole cantaloupes subject to this recall carry a Mike’s Melons sticker or may be unlabeled because this sticker has fallen off. And that the fruits subject to this recall were sold in approximately 1,100-pound cardboard bin containers. In the FDA’s alert, it did not mention any brand names, but only the grower’s name. This would make it more difficult for consumers in particular to identify which melons were involved in the recall.

A: I assume FDA went by the entry numbers recognizing the supplier grower/packer was Agropecuaria Montelibano. They did start questioning brands on Monday, and we told them ours were Mike’s Melons. Everything “Mike’s Melons” is from this Honduras grower, so for us it was straightforward.

The problem is that for companies such as Central American Produce, their brand is used on many products. Mayan Pride brand is used on melons from Honduras and Guatemala. In some regards, that’s more detrimental for FDA to list the brand Mayan Pride earmarking that brand as having a problem. I would imagine FDA, almost to their credit in only identifying the grower, helped companies with brands coming out of more than one country.

At the retail level, if the melon comes from Honduras, they’re saying get them off the shelf.

On Saturday we contacted our three largest customers and told them something was in the wind. They would initiate there own recall, they knew it was a Class 1 Recall. These recall definitions trigger retail action. We have mostly retail customers, and they were already tuned in. Some heard first from competitors telling them, ‘our cantaloupes are Guatemalan, our melons are good to sell.’

Q: How do you think this recall is impacting category sales?

A: The industry is in a shambles as far as the cantaloupe business. The problem is simple, people don’t want them. And it’s affecting honeydew business as well. The Honduras grower is also in honeydews and no one wants those either.

Q: How long have you imported melons from Agropecuaria Montelibano?

A: We’ve been working with this group 15 years. We’ve been down to their facilities with our customers. We’re close to the family and have been to their kids’ weddings. It hurts because they’ve always strived to have the best, safest and cleanest product out there.

Q: What happens now?

A: There will have to be some matter of disposal of product, which needs to be stamped by FDA. We’ll live through it and come out of this as the industry always does.

One of the things that comes across in speaking with the firms that have been involved with Agropecuaria Montelibano is a profound sense of regret. The notion that these are good people, trying to do the right thing, simply overflows from everyone we speak to who knows this operation and the people behind it.

One of the fears that we have regarding this episode is that the FDA is sending the wrong message. When the spinach crisis came, we were told by FDA officials that the recommendation to consumers not to consume spinach was motivated, at least in part, by a sense that the industry had disregarded previous FDA efforts to get the industry moving on food safety. So it was accepted that it was important to take many actions to “rebuild regulatory confidence” so that next time, the FDA would assume a problem was not a systemic failure but, rather, an aberration. This would lead to a more modest FDA action.

Yet this experience with Agropecuaria Montelibano and this “import alert” makes us think this was all wishful thinking. We’ve run dozens of pieces on food safety efforts in the United Kingdom as some believe these are more rigorous than those used in the U.S.A. Yet the fact that this grower has the certifications necessary to sell in the UK seems to matter not at all.

In a sense, the FDA is saying that there is simply no such thing as reputational capital. That an outbreak is an outbreak. Yet taking this attitude reduces the value of investing in an exemplary food safety program.

Which means people will be less likely to do it.

So the FDA’s actions are probably increasing the likelihood of a food safety problem in the future.

One of the things we noted in our first article on this subject is that the FDA was basically telling people to set up their businesses as many discrete corporate entities. This group has at least three farms. Because they all ship as one company, all their product is banned. If they were three companies, only one would likely be banned.

Now George points out an issue with branding. Typically brands look to produce in multiple areas in order to ensure continuity of supply. This is true of Mayan Pride, but also Dole, Chiquita, Del Monte, etc.

Yet it is giving consumers a lot of work to tell them not to eat a brand from one country, but the same brand is fine from another.

As it happens, the point may be moot. We understand nobody wants any melons from Honduras — not only cantaloupes but honeydew, watermelon and other unaffected melons. And melons in general are suffering tremendously.

So the FDA in its infinite wisdom may have decided to crush a whole industry employing countless thousands, for no good reason.

Many thanks to George Manos for helping the industry to better understand the situation.




Media Misinformation And
Confusion Over Cantaloupe ‘Alert’

Plenty of consumer media outlets wound up with egg on their faces when, as we mentioned in FDA Fumbles Again On Cantaloupe ‘Alert’, they started reporting a Dole recall that was actually done in 2007!

To find out what actually happened we asked Pundit Investigator and Special Projects Editor Mira Slott to investigate:

William (Bil) Goldfield
Communications Manager
Dole Food Company
Fresh Fruit and Vegetables

Q: Could you clarify what actions Dole has taken regarding the FDA alert on cantaloupes imported from the Honduran grower? There are all these media reports circulating on the Internet that appear to be spreading misinformation.

A: All the information being reported that Dole has done a recall is erroneous. A reference to a Dole recall of cantaloupes from Costa Rica is all based on last year’s recall and is completely inaccurate.

Q: Have you tracked all product that could be out in the market?

A: Yes. We’re still putting together a formal release, once we find out the status.

We’re still waiting to see what to do next. We haven’t issued any recall yet.

We saw this alert and said we better let everyone know about this. I’m reading the same information as you. I don’t know to what extent Salmonella was found or where they found it.

Q: Any ideas on why the erroneous reports were published?

A: We did have a melon recall in 2007, and somebody put this together with the new cantaloupe issue and erroneously tied bits and pieces of information together.

I’ve seen T.V. reports saying Dole did a recall of cantaloupes in Costa Rica prompted by the FDA alert on cantaloupes from Honduras. It’s peculiar.

There hasn’t been a recall issued from the FDA at this point.

We do have product from this grower. We haven’t received a lot. We’re going from the alert to retain the product we have, and telling retailers that may have it in their warehouses, ‘don’t put it out on the shelves’, and they haven’t.

What is intriguing about our conversation with Bil is three things:

1. The total lack of communication to even the biggest players by the FDA.

2. Enormous confusion by everyone in the industry as to distinctions between recalls, import alerts, product withdrawals and other such matters.

3. Dole had a recall on Costa Rican melons in 2007 also related to salmonella. There was no “cause” ever found. The melon growers of Costa Rica are not using secret techniques they hide from their friends in Honduras. As far as we can see, there is no reason at all to think that the melons from Costa Rica are safer than those from Agropecuaria Montelibano, a Honduran grower.

Shouldn’t the FDA be obligated to explain itself?

Many thanks to Bil Goldfield for taking the time to help the industry better understand this situation.




How Save Mart Was
Affected By Cantaloupe ‘Alert’

We wanted to get a sense of how retailers reacted to the events surrounding the “import alert” that affected product produced by Agropecuaria Montelibano. Save Mart thought it was in the clear and then learned its fresh-cut supplier had some of the questioned melons.

We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more:

Alicia Rockwell
Director of Communications
Save Mart
Modesto, California

Q: What steps did you take at the retail level when news of the cantaloupe outbreak surfaced?

A: We take ownership of recalls with the tools we have. When the FDA issued its alert on Saturday, March 22, our buyers were following up and our suppliers were in contact with us as well. The FDA said the problem was connected to a grower/packer in Honduras. We didn’t have any melons from this grower. We always try to do what we can to educate consumers on food safety issues and recalls.

We posted a sign at point of sale where we merchandise the whole melons advising consumers the products on display were not impacted by the recall. We did that so consumers coming in the stores would know our cantaloupes were fine. The sign said that products on display today are not involved with this recall.

Our toll-free number was on there and the FDA number and website if they had questions. We also put the recommendations from the FDA on steps consumers can take to protect their cantaloupe from foodborne illness using the bullet points from the FDA release. (Editors Note: store managers are instructed to remove the recall sign on Monday, March 31, 2008).

Q: Do you have a photo of the sign on a merchandising display?

A: No picture, but the text reads as follows:

CONSUMER NOTICE: Recall Information

FDA has issued an alert on Cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer because it appears to be associated with a Salmonella Litchfield outbreak in the U.S. and Canada.

Products on display today are NOT involved in this recall.

Call the Save Mart toll free number: 800 692-5710 if you have any questions or contact FDA directly at 888-INFO-FDA or visit their web site at www.fda.gov.

FDA recommends that consumers take the following steps to reduce the risk of contracting Salmonella or other foodborne illnesses from cantaloupes:

  • Purchase cantaloupes that are not bruised or damaged.
  • Refrigerate cantaloupes promptly.
  • Wash hands with hot, soapy water before and after handling fresh cantaloupes.
  • Scrub whole cantaloupes by using a clean produce brush & cool tap water immediately before eating. Do NOT use soap or detergents.
  • Use clean cutting surfaces & utensils when cutting cantaloupes. Wash cutting boards, countertops, dishes & utensils with hot water & soap between the preparation of raw meat, poultry, or seafood & the preparation of cantaloupe.
  • If there happens to be a bruise or damaged area on the cantaloupe, cut away those parts before eating it.
  • Leftover cut cantaloupe should be discarded if left at room temperature for more than two hours.
  • Use a cooler with ice or use ice gel packs when transporting or storing cantaloupes outdoors.

Q: When did you receive information that some of your fresh-cut fruit products might contain the Honduras cantaloupe in question?

A: [March 24] is when we learned from Garden Highway, run by Renaissance Food Group, that they were just notified some of their products might include cantaloupe from this implicated Honduras grower. They said the product in question had a sell-by date of March 22.

We put out a notice to stores immediately to make sure there was nothing remaining; they checked shelves and reported back to our food safety area. In recalls, they tally and pull product and destroy.

It is possible product could have made its way home. We were concerned that it could be in people’s refrigerators. We put out a release and then updated it with additional information that went to all the media and T.V. stations in our markets and print outlets as well.

It provided detailed packaging information and dates so consumers could check. We also run these releases on our consumer websites for Save Mart, Lucky and FoodMaxx Stores. We don’t have a separate button on our websites that consumers can click for food safety alerts like some retailers do, but this is a work in progress.

Q: Did you also alert consumers with in-store signage about the fresh-cut fruit problem following the original signs reassuring consumers your whole melons weren’t involved?

A: We posted signs up in the stores listing specifically which mixed fruit was on the recall notice and the sell-by dates on it. We didn’t have any products in the store at that point but wanted to be sure to inform consumers who might have purchased these products and had them in their homes.

Q: What was consumer reaction? Did they express concern or confusion? Were product sales of cantaloupe or other produce categories impacted?

A: We did get calls initially regarding whole cantaloupes, when people didn’t know what was going on. We assured our customers that our cantaloupes were fine and they seemed to be OK with that. And it was backed up the next time they went into the store and saw the notice confirming what they had been told. The managers moved quickly to get signs up, and at that point we didn’t get many calls.

I didn’t get any messages from store managers that anything was out of hand. If there had been an issue, I would have heard about it, and can assume things were fine.

I’ve been trying to assess if sales were affected, but haven’t gotten feedback yet from the produce managers. I’d take an educated guess that we didn’t experience anything too impacting.

Q: When FDA put out the initial alert on March 22, it named the Honduras grower Agropecuaria Montelibano, but not the brand names that consumers would know. Couldn’t this create more complications?

A: I can’t speak for all retailers, but a majority of produce carries a sticker of what region it came from, and the cantaloupes probably would have had a sticker that would indicate it. The problem is that not all Honduras cantaloupes are bad. Consumers would need to check with retailers to find out if the melons they bought originated from that particular grower.

On recalls, what also can be confusing is they can grow, because you learn about one part, and then several days later learn more, like here where the Honduran grower’s cantaloupes ended up in fresh-cut product. This makes it a challenge. Pre-packed fruit comes into us in cases; it’s not done in-store. There is always a potential the cantaloupe involved in the outbreak could have been used in other products.

Q: At this point, though, do you think you’ve eliminated all the products that could be implicated in this case?

A: At this time, this problem with Garden Highway mixed fruit products is all we’re aware of. If tomorrow, we find out something else is a problem, we will act immediately.

We can only respond as quickly as we receive the information. We are who the consumers associate with most directly. It may have been a supplier or grower or packer that may have done the error or had the problem, but what happens is the retailer is who the consumer looks to. A great deal of responsibility rests on the retailer.

Sometimes suppliers will do a voluntary recall. Based on internal testing, they don’t want to take chances. It might not necessarily reach the FDA, or no sickness has been reported so no evidence exists, but a lot of suppliers will want to be cautious. We act on those recalls like we would on an FDA advisory recall. It makes no difference to us. It’s all a matter of protecting consumers.

Q: Your actions related to this cantaloupe incident seemed to calm your customers. Do you find shoppers generally have confidence in the safety of produce and your role in the process?

A: Consumers are getting antsy about numerous recalls happening. Everyone needs to remember our food supply is the safest in the world; 25 years ago, we didn’t have the testing controls and information we have now. When people got sick, they didn’t have knowledge that it could be associated with foodborne illness.

A lot of recalls occur because of early detection so we are able to get tainted product out of the supply chain before it compromises anybody. We’re still putting up consumer notices and letting our shoppers know we are acting. Consumers just have to have some confidence in the process. They need to know that things have gotten better with diligence at all levels.

Q: With food safety demands intensifying on the supply side, what is your perspective as a retailer?

A: Obviously our suppliers do extensive food safety measures and internal testing at grower and processor levels to insure safe food and hopefully get problems out of the system before there is harm. Everybody has their responsible part, and we have to do what we can at store level because we’re the last place product ends up before it reaches the consumer.

We have our own internal food safety certification program. As part of our due diligence as a company, here within the retail environment, we have a lot of practices to protect food. Store managers and assistant managers are all certified in food safety through the national registry of food safety professionals, which they are required to maintain getting recertified every two years, and department managers go through our own internal food safety course.

When these recalls happen, our buying teams are integrally involved. They have a strong knowledge of who they buy from. We require certification of suppliers’ safety practices in cultivating, growing, processing and packing, and we know they have a paper trail to track where product is coming from and going to.

Our suppliers communicate food safety information if it impacts us and we can share our knowledge with consumers. If they call on our toll free line, we’ve gotten the information from our buying source. We also notify our stores. Managers are in the loop from the beginning. They can talk to customers at the store level. Notices are posted at point of sale. If our customers are still confused, they can go to our consumer line and we can answer their questions or refer them to government or industry organizations to learn more.

But the consumer has a responsibility to get food home in a way that doesn’t jeopardize the integrity and to follow good food safety practices at home. We don’t expect every consumer to go through a food safety course, but we can teach them the simple things like don’t cut up fruits and vegetables and meat on the same cutting board. We must take responsibility as an industry to educate consumers.

A few significant points:

Retailers view a statement by the FDA as gospel. What choice do they have? Imagine the liability of getting a notice from the FDA and then selling something from which a consumer gets sick. No chain will take that liability. As a practical matter the FDA power to make pronouncements is functioning like a constructive recall.

Traceability has to be a characteristic of the fresh-cut industry and its products. It doesn’t seem wise for retailers to have to wait for vendors to give them information. Every lot number should have connected to it all the sourcing data so that any retailer could log into the vendor’s website, enter a lot number and know the answer to the supplier instantaneously.

Although Alicia Rockwell didn’t have sales data, shippers of melons from other places tell us that demand has collapsed for cantaloupes. What we don’t know is if this is consumer hesitation or if retailers are just deciding to go without cantaloupes for a while or if they are just reducing space allocations and not putting them on ad.

In any case, we appreciate Alicia Rockwell and Save Mart letting the industry know how they dealt with this particular situation.




Consumer Guide To
Cantaloupe Food Safety

With all this talk about cantaloupes and salmonella, we’ve been asked to provide some of our retail readers with information they can pass on to their customers regarding how to reduce the risk of such contamination on cantaloupes from any source.

Trevor SuslowFortunately food safety superstar Trevor Suslow, Extension Postharvest Specialist for the Department of Plant Sciences, UC Davis, has developed a handy piece entitled:

SALMONELLA AND CANTALOUPE:
WHAT CAN CONSUMERS REALLY DO?

Experience with overall consumption of cantaloupe purchased and prepared in the home should give consumers confidence in the safety of this nutritious and enjoyable fruit. Many improvements in food safety awareness and management have been put in place by domestic and international producers and shippers, particularly over the past three years, which are also providing a foundation for confidence in the supply of cantaloupes throughout the year. However, no one can guarantee an absolutely risk-free system for melons grown in an open environment despite the best of precautions and intentions.

Consumers have a precautionary role in food safety with cantaloupes and that involves adequate washing just prior to cutting for consumption and timely refrigeration of uneaten fruit. Washing and scrubbing under running tap water is all we recommend but some consumers are sufficiently concerned to use a variety of disinfectant treatments. These are challenging to perform in the home but may add a little extra benefit if done correctly.

Though we don’t advocate the necessity for these extra wash steps, for some the effort is worth the piece of mind that “what can be done has been done”.

The piece is quite comprehensive and you can download a copy here.




Science Behind Cantaloupe ‘Alert’

When the FDA was unable to answer many questions regarding the science that surrounds this “import alert” and the general issue of salmonella and cantaloupes, it was suggested we talk to Professor Michael Doyle who has done some research in this area. We asked Pundit Investigator and Special Projects Editor Mira Slott to help us learn more:

Michael Doyle Dr. Michael Doyle
Regents Professor of Food Microbiology
Director Center for Food Safety
Dept. of Food Science & Technology
University of Georgia

Q: Could you shed light on the science of salmonella contamination with cantaloupes?

A: We know melons in general and cantaloupe particularly are a highly nutritious medium for growing bacteria if it gets to the meat. The pH in melons is closer to neutral than many fruits, so there are not a lot of microbial barriers to prevent pathogens from growing. E. coli and Salmonella will grow very well in cantaloupe if left at room temperature. The other problem is that bacteria can get trapped in the grooves and crevices of the uneven surface of the cantaloupe and is difficult to remove.

Q: Could you point to studies that have analyzed the impact of foodborne contamination in cantaloupes?

A: Scientists at Texas A&M conducted studies looking at the irrigation water used for cantaloupes grown in Mexico and the U.S. near the Rio Grande River and found substantial contamination in the water. One particular serotype of Salmonella has been a nemesis for the cantaloupe industry. A report in the Journal of Food Protection a few years ago detected Salmonella Poona in irrigation water used for a cantaloupe farm in Mexico implicated in Salmonella cases in the past. Irrigation water is certainly a possibility for the source of the recent cantaloupe outbreak.

Q: What is your take on this cantaloupe outbreak, which the FDA linked back to a Honduras grower?

A: I know the government of Honduras and the grower are questioning the FDA’s actions and I read something about a lawsuit.

My experience with CDC is that they are adept at identifying these outbreaks with their epidemiological data. Depending on what the risk factor is, if it’s above two or three, usually that’s pretty strong statistical evidence that whatever they’ve identified as the source is right. If the odds ratio is above three, it’s a strong ratio.

Based on my past associations with CDC outbreak investigations, there’s often a cry by those identified as the source that they haven’t isolated the agent from their product. The reality is that the epidemiology being used by FDA to advise recalls is valid. I’ve been around this long enough to know that the epidemiological data is very compelling.

Q: Another issue being raised is the timing of the FDA import alert and advisory recall. FDA says the outbreak started beginning of January and the last case was reported on March 5, with the cases following a bell-shaped curve, yet the FDA didn’t issue its alert until March 22. Based on incubation periods for Salmonella, wouldn’t the danger be over by then?

A: The incubation period for Salmonellas is usually in the range of 12 hours to several days, some suggest a week. But who knows where cantaloupe could be; my wife sometimes freezes it. Most perishable product outbreaks have this bell shape curve. Perishables in general are consumed quickly, not like peanut butter, which is stable over several years.

With cantaloupe, it’s difficult to disinfect if its gets in the grooves and crevices of the irregular surfaces. Another point needs to be considered. The FDA wants to find out what caused the contamination, and it needs to do an investigation not just of the field, but the processing plant and other potential problem areas to make sure good agricultural practices are being applied.

Think back in the late 90’s and the problems with raspberries grown in Guatemala; you had to cut imports off. They did that with Mexican cantaloupe some time ago too. We can’t sell more until we determine the problem. It’s prudent of the FDA to do this because we don’t know if the grower or processor has solved the problem. If there’s a reoccurring problem, the FDA would be found at fault if more sicknesses occurred. The most prudent thing to do is stop imports of this product to see if an investigation can determine where the problem originated.

Professor Doyle is respected for his work. He is, however, extremely risk-averse when it comes to food. For example, USA Today interviewed him in the midst of the spinach crisis of 2006 in a piece mostly about Fresh Express. Professor Doyle’s position on personally consuming packaged salads was explained this way:

Doyle won’t eat packaged salads. He says the process, including the mixing of leafy greens inside a processing plant, increases risk of contamination.

Now, of course, everyone makes choices in life and far be it from us to tell the good professor what to eat and what not to. However, it is very clear that few consumers are so risk-averse as to accept this kind of restriction on their own activities.

The Professor’s explanation of the science of salmonella and cantaloupe is intriguing. But on the points specific to this import alert, they still leave many questions unanswered:

1. It is one thing to say that CDC has competent epidemiologists. It is another thing entirely to make a judgment about this specific case. Professor Doyle gives some specific criteria: “Depending on what the risk factor is, if it’s above two or three, usually that’s pretty strong statistical evidence that whatever they’ve identified as the source is right. If the odds ratio is above three it’s a strong ratio.” The CDC, however, has released no information to allow us to check against Professor Doyle’s criteria.

2. Professor Doyle does make the important point that it is unreasonable to expect to find the food item with DNA on it that proves the tie to the food safety outbreak. Although this may be the gold standard, in the vast majority of cases, it is an unreasonable expectation. In the spinach outbreak of 2006, we were able to get this “hard evidence” because bags of spinach are consumed in servings and held — so they were available to be tested. Most bulk produce is eaten and disposed of long before anyone is thinking about testing it.

The industry may not like this but circumstantial evidence is still evidence and people go to jail every day based on it. Just as we don’t need a smoking gun to convict a person for murder, we also don’t need physical evidence to determine the cause of a food safety outbreak.

This being said, it must be recognized that the CDC and FDA can make errors. Some people might have ulterior motives, and when we act without hard evidence, a high degree of transparency is essential to prevent the abuse of process or a mistake in the process.

3. The suggestion that there was a public health risk because “…who knows where cantaloupe could be; my wife sometimes freezes it” is not a justification for such broad action. If the concern is that some infinitesimal number of consumers have frozen cantaloupe in their freezers or have made cantaloupe marmalade, a notice advising consumers to dispose of any products made from cantaloupes imported in January and February would have sufficed.

4. Whatever happened in the past with other countries, there is no reason whatsoever why shipments have to be banned and product thrown in the garbage before we start an investigation. In this case where nobody has gotten sick for weeks, we could have called up this company and asked for permission to send an FDA inspector. They would have cooperated. If not, maybe that would be a reason to consider a ban.

5. The notion that “We can’t sell more until we determine the problem” is simply not a reasonable standard. Even assuming there was a problem with this company, there is a high likelihood we will never know the cause of the problem. How can we? We will send some people to walk around fields that, maybe, had some salmonella back in January. If you pay people to find things they may speculate on possible causes but even with the FDA, USDA, CDFA and others completely focused in a no-expense-was-too-great search for the cause of the spinach crisis, no cause was ever found. We have a bunch of speculation dressed up in a fancy report.

When Dr. Doyle says that “The most prudent thing to do is stop imports of this product to see if an investigation can determine where the problem originated,” what he means is this: If the only thing that matters in the whole world is food safety, then anytime there is the whisper of a problem, cut off the product until we persuade ourselves we know what caused the problem and have corrected it.

And actually, we would agree with Professor Doyle, except we would also hold that such circumstances — that food safety is the only thing that matters in the whole world — never exist. Reasonable men deal with probabilities, not possibilities; reasonable men balance competing interests such as the benefits of eating fresh fruit and the importance of predictability in trade.

The bottom line here is that the whole thing was announced after the outbreak was over. Such small hangovers as professor Doyle’s wife’s frozen cantaloupe could have been handled in a far more constrained manner. This is an enormous loss to a poor country and for absolutely zero gain in food safety.

Many thanks to Professor Doyle for helping enlighten the industry with regard to food safety.




President Of Honduras
Stands Up For Grower

When the history of this cantaloupe/salmonella/FDA alert situation is written, one of the true heroes will turn out to be the president of Honduras, Manuel Zelaya.

Under normal circumstances, the FDA would simply crush Agropecuaria Montelibano, the Honduran grower and packer implicated in this matter. In fact the more Agropecuaria Montelibano objected and proclaimed its innocence, the tougher FDA would get.

Its only hope as a private company would be, and may still windup being to announce, as the spinach industry did, a ridiculous “re-start” in which everything was being “sanitized” — the only purpose of which was to give cover to FDA so it could justify its allowing the industry to ship again.

President Zelaya, though, aside from adding political heft to the pleas of the company, is the only politician willing to state the obvious: Whatever was once true, the fruit today is as safe as any other fruit.

In fact, he grabbed some media exposure by eating some of the implicated cantaloupe :

HONDURAN PRESIDENT DEFENDS MELONS BY EATING ONE

TEGUCIGALPA, Honduras (CNN) — He’s no Julia Child, but Honduran President Manuel Zelaya showed Tuesday he can attack a cantaloupe and U.S. government claims in a single motion.

It’s not in our fruit,” he said about last week’s report by the U.S. Food and Drug Administration that some Honduran cantaloupes may be contaminated with salmonella. “It’s not true what they are saying. Logically, we believe it is an error.”

Then, the 55-year-old father of four asked the viewers of CNN en Español to indulge him as he engaged in a show-and-tell demonstration. “Permit me a second,” he said as he stretched his left arm across the tabletop and outside the view of the camera, then pulled into view a box of fruit.

“Here I have the box of melons that we are exporting to the United States; here are the protective bags,” he said.

Zelaya lifted a cantaloupe from the box, placed it in front of him, then grabbed a knife and a fork.

“Permit me to make a demonstration,” he said, then cut open the fruit, sliced off a chunk, put it in his mouth and chewed vigorously.

“I eat this fruit without any fear,” he said with his mouth full. “It’s a delicious fruit. Nothing happens to me!”

Although the demonstration doesn’t prove anything, since salmonella doesn’t affect one instantaneously. It demonstrated political support at a crucial moment.

You can see the video, which is in Spanish, right here.

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