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Why The Delay?

Jim Prevor’s Perishable Pundit, March 28, 2008

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.

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