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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 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.

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