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Special Edition X — Salmonella Saintpaul Outbreak… FDA’s Contempt For Industry Causes Pain And Suffering

Lukewarm Indictment of Jalapenos:Solving Outbreak RequiresThinking Outside the Box

The bottom line is that the more the CDC and FDA speak, the more obvious it becomes that three months into this outbreak they do not have a rational explanation or even a reasonable theory to explain this Salmonella Saintpaul outbreak.

The latest announcement adds more smoke than light to the outbreak:

An initial epidemiologic investigation in New Mexico and Texas comparing foods eaten by persons who were ill in May to foods eaten by well persons identified consumption of raw tomatoes as strongly linked to illness. A similar but much larger, nationwide study comparing persons who were ill in June to well persons found that ill persons were more likely to have recently consumed raw tomatoes, fresh jalapeno peppers, and fresh cilantro. These items were commonly, though not always, consumed together, so that study could not determine which item(s) caused the illnesses.

Recently, many clusters of illnesses have been identified in several states among persons who ate at restaurants. Most clusters involve fewer than 5 ill persons. Three larger clusters have been intensively investigated. In one, illnesses were linked to consumption of an item containing fresh tomatoes and fresh jalapeno peppers. In the other two, illnesses were linked to an item containing fresh jalapeno peppers and no other of the suspect items. The accumulated data from all investigations indicate that jalapeno peppers caused some illnesses but that they do not explain all illnesses. Raw tomatoes, fresh Serrano peppers, and fresh cilantro also remain under investigation.

Basically the CDC is scrambling for highly unlikely explanations. On today’s conference call, the CDC suggested a search for a farm that had been growing tomatoes and then, perhaps started growing jalapenos midway through the outbreak.

A few key points:

1) This suspicion of jalapenos and Serrano peppers is still just another epidemiological theory — much as CDC had a theory about tomatoes a month ago. With thousands of samples taken, they still haven’t found Salmonella Saintpaul on any jalapenos or anywhere jalapenos were served.

2) CDC hasn’t given the date of the three restaurant clusters, so we don’t know the relevance to public health today.

3) Although illnesses in two of the clusters were linked to items containing jalapeno and no other SUSPECT item, that does not mean they contained only jalapenos. If the outbreak was caused by a non-suspect item, such as tortillas, those items could still be at fault.

4) Note the advisory refers only to those with impaired immune systems — that is always prudent. Note that this is much “softer” than a recall or “recommendation not to consume” — which probably indicates lower confidence in its finding by the CDC.

We think we need an approach that might not show up on the surveys. We want to suggest looking at two other possible vectors for this outbreak:

A) Chicken — via cross-contamination

Chicken is commonly used in Mexican cuisine and is a common carrier of Salmonella. The CDC hasn’t looked at chicken because the surveys don’t show disproportionate consumption by sick people.

What if, though, the chicken is carrying the pathogen but, because it is properly cooked, the chicken itself doesn’t get people ill?

Instead, the raw chicken is improperly handled; it contaminates the produce in the restaurant and that is how people get sick. This would never show up in the CDC surveys as a chicken issue — but it would be.

We think we need to do some swabs at chicken-processing facilities looking for this relatively rare form of Salmonella.

B) Employees — via inadequate hand washing

With over a thousand people sick and a multiplier of over 30 to account for sick people who aren’t counted, we are talking about around 35,000 people estimated to be carrying or have carried this Salmonella Saintpaul strain. Many of these people must work in foodservice.

In the midst of the spinach crisis of 2006, we ran a piece about a Salmonella outbreak at a Wal-Mart store in Indiana. The story included this note from the Indiana Department of Health:

“We believe food handlers who didn’t have any symptoms may have contaminated the deli and bakery products.”

How ever this started — what if it is being spread by those 35,000 sick people, many, perhaps, asymptomatic? There has been zero mention of doing stool samples and health histories on the restaurant workers. We should do both.

When you listen to these calls, one doesn’t get any sense of confidence that the government is on the way to solving this problem. CDC seems to be very caught up in certain standard operating procedures and, perhaps, when an outbreak is this different, it requires thinking outside of one’s training and experience.

It is not obvious that the system set up by CDC and FDA is conducive to this type of creative thinking.

Special Edition X —
Salmonella Saintpaul Outbreak…
FDA’s Contempt For Industry
Causes Pain And Suffering

CNN Wrongly Blamed For
FDA’s Calculated Ambiguity

Over the July 4th weekend, news broke on the Salmonella Saintpaul outbreak that we thought sufficiently important to give up some of our holiday and make sure we dispatched a Special Alert containing the information that the government would be doing enhanced inspection of certain items on Monday.

We thought this vital to get out because we felt many shippers and receivers might want to change their plans rather than have their product restricted from sale by FDA while awaiting the result of testing. We also thought that our readers at retail and at restaurants should be aware the supply chain might be disrupted.

The overall piece was entitled, Watch Your Orders: Product May Be Held At Border, and it included these paragraphs:

CNN is reporting that the US will “halt the shipment of ingredients common to Mexican cuisine from Mexico to the United States” starting Monday. Tommy Thompson, former Secretary of the Department of Health and Human Services, which controls both FDA and CDC, has been briefed on the situation and he explained the intent:

“…the plan involves intercepting food samples at the border and sending them to laboratories to examine them for possible salmonella or E. coli.”

No official announcements have been made, but the intent is said to include holding cilantro, jalapeno peppers, Serrano peppers, scallions and bulb onions at the border.

As if we needed another example, this is a further illustration of the incompetence of FDA’s and CDC’s management of this outbreak and utter contempt for the business community that such information was delivered via CNN’s investigative reporting rather than a timely and official FDA communication.

Since we were one of the media outlets that spread CNN’s report, we knew we would have no choice but to comment or issue a correction and so immediately asked PMA to clarify if it was simply passing on FDA’s position or if it was making a statement of fact based on input from its members. Bryan was kind enough to send on a clarification on the morning of July 8 of how that July 7 statement had transpired:

Bryan SilbermannI wanted to take a moment to dispel a rumor that has been circulating regarding FDA closing the U.S./Mexico border and halting imports of several produce items that are being investigated in connection with the Salmonella saintpaul outbreak.

According to a top official at FDA with whom I’ve spoken today, this rumor appears to have originated from an erroneous news report by CNN over the weekend. CNN’s report was picked up by other media outlets and spread widely. Please note that FDA has no plans to close the border to these products, and has asked CNN to issue a correction to the story.

FDA did announce last week that, starting this week, it would be increasing its sampling of imported and domestically grown serrano and jalapeno peppers as well as cilantro. As is the case when FDA takes samples in this manner, the balance of the same product from the load being tested needs to be held until test results are available. These results typically take between 3 and 7 days to complete, depending on the outcome.

Again, I want to repeat that FDA has categorically denied any comments or plans to close the border to the products in question.

We immediately asked PMA to clarify if it was simply passing on FDA’s position or if it was making a statement of fact based on input from its members. Bryan was kind enough to send on a clarification on the morning of July 8 of how that July 7 statement had transpired:

My note came in response to a great deal of confusion caused by the erroneous media reports which CNN’s report appeared to have spurred. These reports led to member calls to PMA staff concerned about the accuracy and impact they were having on the marketplace and availability of product. For example, some major buyers were being told by their pepper suppliers that they would not have peppers (either jalapeno or Serrano) available because the border was being closed — a huge issue particularly for some restaurants that use a lot of these products. Other suppliers were being told by buyers that they didn’t want to order those products being sourced in Mexico because the buyers had heard the border was being closed or the products being “banned”. So a vicious circle of rumor and misinformation had been created.

I personally placed a call to Dr. David Acheson in the early afternoon yesterday and asked him to please clarify, preferably in writing, exactly what the FDA’s position was so that we could advise our members what FDA was doing and saying. At the same time I called the staff at the Fresh Produce Association of the Americas in Nogales to discuss what they were seeing and hearing on the ground at the crossing there. And I placed calls to some major distributors who source these products from the U.S. and Mexico.

The e-mail we sent out yesterday evening was based on the sum of all those conversations.

Early this morning I received the following written communication directly from Dr. Acheson at FDA:

David Acheson“As part of the Salmonella Saintpaul outbreak investigation FDA has recently issued assignments to increase the testing of domestic and imported cilantro, basil, jalapeno and Serrano peppers. Regarding samples of the aforementioned imported produce, depending upon the port of entry and FDA resources, sampling may be conducted at the border or at destination. Produce items that have been sampled at the border can proceed to their destination but may not be distributed until FDA releases them.

Once the samples arrive in the laboratory it typically takes FDA 3-4 days to determine if salmonella is present or not. While the percentage of shipments being tested will vary, FDA currently anticipates that it will not be undertaking 100% testing of these specific products. In fact, the assignment specifically requests that a limited number of samples be collected from a variety of sources.

FDA will be monitoring the sampling assignment and the results and will adjust the assignment accordingly. The sampling assignment is to test for the presence of Salmonella and is not a “ban” on the importation of these products.”

We can hardly blame Bryan or PMA for trying their best to get their members the most accurate information. It is FDA that is first and foremost at fault for acting in such an ambiguous manner that Bryan felt the need to ask for clarification at all. After all, PMA is not the FDA’s newswire, and FDA has independent responsibility to speak clearly and in a way that minimizes disruptions to the flow of commerce consistent with its responsibilities to enhance public health.

Still we think PMA’s initial release was not artfully worded. In this case, PMA put itself in between a dispute between FDA and CNN, and it is not clear why PMA should put itself in that position.

Although, as PMA explained, FDA may have asked CNN for a retraction, it would have been advisable for PMA to point out that CNN had REFUSED to issue such a retraction claiming that its piece was accurate.

In fact, CNN’s report, Some Food from Mexico to Face Testing, was accurate. It never said that the government planned to “close the border.” It stated — what is undeniably true — that former Health and Human Services Secretary Tommy Thompson said this:

The inquiry, which initially focused solely on tomatoes, has expanded to include cilantro, jalapeno peppers, Serrano peppers, scallions and bulb onions, said Tommy Thompson, former secretary of the Department of Health and Human Services, who said he has been informed of the plan.

Thompson said the plan involves intercepting food samples at the border and sending them to laboratories to examine them for possible salmonella or E. coli.

As far as the substance of CNN’s report, some of our sources on the border are quibbling with details, saying that FDA is not testing bulb onions, and sources tell John McClung down at the Texas Produce Association that FDA also is testing basil. The bigger issue, though, is that nobody in the produce industry is going to be particularly interested in what words FDA uses to define its actions… they want to know the substantive nature of those actions.

The bottom line is that few producers are going to ship product that has overwhelming odds of being restricted from commerce and allowed to depreciate. Even if that 3-to-7-day hold for testing typically is accurate, there is no guarantee on that number and the FDA reserves the right to hold the stuff indefinitely and leave the owner with depreciated product, desperately trying to sell cilantro soup rather than cilantro.

Not only are the odds stacked against shippers and the time it takes for clearance, there also is no way of knowing from FDA’s cryptic statements how much more of the producers’ shipments will be tested. After all, it is one thing if FDA simply is ramping up its inspection regimen — say going from the usual half a percent to a full percent or even 2% of all shipments — but it is another thing entirely if FDA is going to inspect 50% or 90% of shipments.

We certainly have no idea what percentage of the loads are being inspected from reading Dr. Acheson’s statement to Bryan:

“FDA currently anticipates that it will not be undertaking 100% testing of these specific products.”

Technically this statement may not constitute “closing the border” on these products, but few shippers indeed are going to ship under a response like that. So for all practical purposes, one might as well say that FDA closed the border on these products. So finding out, exactly, what FDA had in mind was crucial.

It was good of PMA to solicit a written statement from FDA, but the content of FDA’s statement — with its calculated ambiguity — illustrates so much of what is wrong with management at FDA. This statement — with its only point being FDA might sample 99.9% — is reason enough why this agency, whose contempt for anyone outside its hallowed halls drips off its every word, needs a major overhaul.

If FDA requires samples of 10% of all shipments, let it say so. If it intends to sample 50%, let it say so. If it must sample every single shipment, let it say so. What purpose is served by not speaking the truth?

Special Edition X —
Salmonella Saintpaul Outbreak…
FDA’s Contempt For Industry
Causes Pain And Suffering

Energy And Commerce Committee
Should Think About Commerce
In Hearings On ‘Broken’ FDA

In a little ironic twist, it is the Committee on Energy and Commerce — chaired by Representative John D. Dingell (D-MI) — and, specifically, its Subcommittee on Oversight and Investigations — chaired by Bart Stupak (D-MI) — that soon will hold hearings related to the Salmonella Saintpaul outbreak. The hearings will be “…examining the inability of the Food and Drug Administration (FDA) to identify the cause of the recent national outbreak of salmonella.”

The position of the Democratic majority on the Committee is well articulated: “Until FDA has the leadership and resources necessary to keep bad food off our grocery shelves and dining room tables, Americans will continue to be concerned that the food they eat may not always be safe… If it hasn’t been made abundantly clear through our eight previous food safety hearings, this salmonella outbreak should leave no one doubting that the FDA is broken. We need a modern FDA equipped with not just the financial resources but also the regulatory tools to adequately prevent and respond to future outbreaks.”

Although we agree that more resources will be necessary to have a world-class CDC and FDA and, even more so, to bring our state labs up to snuff and, by definition, better leadership is better, we confess that we have some trepidations about simply pouring money into the same structure.

We believe the current inspection regimen on the Mexican/US border is an excellent example of how FDA needlessly cripples commerce in America… a matter one would think would be of some interest to the members of the Committee on Energy and Commerce.

Here is a situation in which the FDA, by its own acknowledgement, is searching for the cause of which it only has a few hunches. So, unlike cases where a certain product is implicated after interviewing sick people and FDA searches for that particular product at a farm as probable cause, none of the farmers of any category of product is believed to be a suspect of this problem.

In fact, if the FDA is sampling cilantro, jalapeno pepper, Serrano pepper, basil, scallions and tomatoes for this rare strain of Salmonella, this means that either five of the six products are NOT implicated or they are all grown together on some bio-diverse farm. In either case, well over 99% of the farmers shipping these products are completely uninvolved in the outbreak. So this type of sampling is best viewed as a kind of research project.

So the Committee on Energy and Commerce ought to ask FDA why is it necessary to hold these products when more than 99% of the tested items will come back negative? Without a doubt, if the FDA wants to extract tribute from the produce industry by stealing a few items for testing from every van, the industry would gladly contribute.

In fact, if the FDA continues such a sampling program indefinitely, it might be doing the industry a favor by elucidating the baseline occurrence of various pathogens so we would understand what would constitute progress in reducing the level of pathogens.

The key, though, is that for literally no reason, FDA is disrupting the flow of commerce by not allowing any of these products to be sold. Understand that not only is 99-plus percent of the product from farms that have nothing to do with this outbreak — even if it is a farm-based outbreak — but, also, the sample size is too small to assure safety even if there is Salmonella Saintpaul on the actual van being tested. FDA would need to perform a Monte Carlo simulation to ascertain the sampling necessary to gain a statistical assurance of an absence of Salmonella in the trailer.

And since we are only testing for Salmonella, even this methodology will provide zero protection against any other pathogen, incorrect pesticide application or any other risk.

If FDA decides to release all the product for sale, it will still have the name of the farm, etc., that shipped the product. Some additional product may enter the food supply, but FDA can recall the product instantly and go back to the farm at once.

The price we pay is some contaminated product might slip through, but statistically, the odds are little different than if they just randomly stopped vans of produce.

So why is the FDA doing this? Here are three possible answers:

1) Habit — this is the way the FDA does sampling and so set in its ways are the leaders that they just didn’t think of doing it another way.

2) Statistical ignorance — the FDA doesn’t understand the math and actually thinks it is doing something to enhance public health by stopping the sale of these shipments.

3) Self Preservation as a Priority — What the FDA is worried about is not public health — stopping these vans is statistically going to give you a number indistinguishable from just randomly stopping vans of produce — but self-preservation. If people get sick from something that FDA didn’t know about — it is off the hook. But if the FDA had actually had a van in its possession that later tests positive, it would be attacked for putting public health at risk and FDA officials simply don’t want that burden.

Still, a member of the United States House of Representatives serving on the Committee on Energy and Commerce should have a more-than-passing interest in making sure that public health operates in a manner that does not unnecessarily burden commerce.

After all, safe food is unlikely to be produced by a bunch of bankrupt farmers. And consumers, while wanting safe food, also want economic prosperity.

What the Representatives on the committee have is the virtually unique power to compel FDA to answer questions. So we hope a Representative will ask the FDA how it calculated the cost and benefits of restricting the sale of all these products until the test results came back. We hope a Representative will further ask to see the comparative study done on the cost and benefits of letting the products be sold from the vans from which tested product was drawn.

Although we doubt FDA has done any of these cost-and-benefit analyses, the question will reveal the casual and lackadaisical kind of thinking that seems to inform decision-making at the FDA.

Special Edition X —
Salmonella Saintpaul Outbreak…
FDA’s Contempt For Industry
Causes Pain And Suffering

Reality On The Border:
Businesses Suffer At Hands Of FDA

With all the controversy and confusion regarding what precisely the FDA may be doing on the US/Mexico border, we thought it best to reach out to some industry members who are dealing with the realities of what is happening.

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

John McClung
President, CEO
Texas Produce Association
Mission, Texas

Q: What is the latest information you’ve learned from FDA?

A: I haven’t gotten a straight answer from FDA. FDA is increasing sampling of basil, cilantro, jalapenos and Serrano peppers. They are doing it under a hybrid system. I don’t know what increased sampling means. It’s not just at the border but other places in the distribution chain.

Unless there is a specific reason to believe there is a health risk, any product sampled can normally be moved into commerce. It’s up to the company to make the decision if they want to risk a recall. Most of the time, it’s not much of a risk. But in this case, FDA is not allowing distribution at the end of the chain. So product cannot go to the end user. It’s a mechanism of preventing backing up at the ports. As a practical matter, it takes four or five days to get results on average, and there will be a lot of samples that go a lot longer than that. The closest lab to Texas that FDA will use is in Arkansas.

The bottom line on this is that FDA doesn’t have any idea what caused this outbreak, and the agency is on a fishing expedition. The wider they cast the net, the more damage is done and the less likely they will come up with the solution. FDA was long overdue to switching the focus from tomatoes to salsa and other things. Now that they’ve imploded the tomato market, they’ll work their charm on other commodities.

Q: Some suppliers have been hesitant to harvest product.

A: Jalapenos can be left growing for a while, so there is no point in harvesting if product is going to sit in the pipeline deteriorating.

Q: Several executives said they heard that FDA might clear a company’s shipments after testing a total of three loads.

A: Bare in mind FDA has just started this testing process so it is still feeling it out. Unfortunately, I don’t think that will happen and FDA will continue testing all shipments.

Three loads is the standard, but FDA is not operating under standard procedures. I have calls in to get more answers. This is serious when FDA starts messing with our jalapenos. Texas is a place where you walk into a McDonald’s and they ask if you want jalapenos with your burger! Don’t mess with Texas jalapenos!

An old political hand, John’s comments include some down-home Texas wisdom: “The wider they cast the net, the more damage is done and the less likely they will come up with the solution.”

After our conversation with John, FDA fingered jalapenos but with the caveat that their implication didn’t explain the outbreak. At last word, the FDA was searching for a farm that was growing both tomatoes and jalapenos during the course of the outbreak.

Will Steele
President, CEO
Frontera Produce
Edinberg, Texas

Q: Could you update us on what is happening with your shipments?

A: Short of confusion, I can’t really tell you much more than what you already know. It’s pure frustration. I’ve been through FDA testing and analysis many times before. This one is the most frustrating because it feels like commodities are being singled out for no good reason.

We got notification about a week ago, Monday (June 30) they were going to start doing sampling analysis. Monday two loads came across and they flagged one for testing.

Q: What happened to the un-flagged load?

A: I’m fairly certain they brought the other in and distributed the product. Tuesday (July 1) rolls around and another load coming across is held for analysis. I personally called FDA on Tuesday to find out what was going on. I understand random sampling, but it is very unusual to hit two truckloads two days in a row. At this point, we put all product on hold. I heard about FDA’s expanded investigation in the media.

I called one local FDA agent and asked, what’s going on, and he said, we’re not at liberty to talk about it. The agent eventually explained that he had to sample cilantro, basil, jalapeno and Serrano peppers and green onions. I called another agent in another locale who said this is standard procedure. We must hold product until analysis is completed for clearance.

We took samples out of those same lots on Wednesday, July 2, for testing at an independent lab.

On Thursday evening before the July 4 holiday, FDA said they weren’t working and it would be anywhere between three and eight days to get results back. Now FDA is saying it needs a couple more days.

Q: What about the samples you sent to the independent lab?

A: We got them back really late yesterday (July 8) and they were negative. This morning, FDA just released lab results from that first shipment held Monday June 30 and the results came back negative. The results from that Tuesday shipment are still pending but we’re hopeful. We started harvesting again. We heard a rumor that FDA would test a total of three shipments, one more and then we’d be OK, but they may or may not. It’s up to their discretion.

I’m an optimist. I think the FDA, after hitting dead ends on fresh produce, will hopefully shift focus to where it should be. The outbreak is probably related to processed goods and they’re looking in the wrong closets.

The methodology was flawed. They don’t share information. It would be much more productive for FDA to sit with industry executives and trade knowledge. FDA needs to eliminate its us-versus-them mentality. We all want safe food. FDA has a difficult job. This outbreak is scary and the source needs to be found.

Q: Based on shelf life issues with these items, it sounds like product held for testing creates an untenable scenario for product salability.

A: Our biggest issue is that we have no real clear-cut information other than speculation. One major chain is halting the purchase of cilantro at this point until they get clarification and until then will buy domestic. The problem is starting to snowball. Jalapenos are scarce. There is no proof, and the financial impact can be great. We are starting a big program in two weeks out of Chihuahua. If this drags on, that could be devastating. My concern is that the first case in this outbreak was April 10. My peppers didn’t exist at that time. What did exist on April 10 doesn’t exist either because it’s down the sewer system by now.

What type of hold status we’re under has been clarified through the Texas Produce Association. You may ship product through normal distribution channels but it can’t go to customers. A wholesaler in St. Louis can’t ship to a chain store or food service operator because it risks ending up in the mouth of a consumer. If a positive result comes back, we have to recall. We never ship when product is under analysis. It is ignorant to do so when you don’t know the results. Even if it’s presumptive positive, it still means you have to bring product home.

Q: So at this point, you’re holding all product?

A: We’ve had two truck loads of jalapenos on hold since last Monday and Tuesday. We ceased harvesting. There is no sense in bringing in more product and having it rot.

Q: So in a round about way, while the border isn’t closed and you’re free to harvest product and bring it across, you feel the risk is too great, so in the end the result is the same?

A: One agent said it would sample up to three loads. Our customs broker has the power of attorney to speak with FDA on our behalf. We arranged that. They conveyed to FDA we’d do up to three loads of sampling. FDA is not revealing what’s happening. But in clarification of hold status, FDA now says that sampled produce, basil, cilantro, jalapenos, Serrano and possibly other products can be moved into the distribution chain before lab results are received, but can not be sold until results come back negative. They won’t back up loads at point of entry. That’s how they wash their hands of it. Essentially, there is no option but to stop bringing in product.

When I asked that one agent on Tuesday (July 1), are you going to pull more product, his reply was, that’s solely up to the agent’s discretion. That’s not true. This is an agency policy, a directive from the government. They’re saying I can ship, but it does no good till it gets to the end user. If I can’t sell the product, what’s the point? You’re not holding up the border, just piling up product down the pipe line.

Methodology is backward, FDA is reaching for answers. You can’t tie jalapeno pepper shipped on June 30 back to April 10.

Q: Do you have products other than jalapenos flagged for testing?

A: We bring in 80 different products. Cilantro, jalapenos and Serranos are products we handle that are related to this investigation. So far it’s just jalapenos that have caused problems for us. FDA isn’t stopping our cilantro, but the reason why is that we go through a vendor in the states who sources from Mexico. That vendor has been scrutinized. It’s not under my name so I’m not affected. I have the option to source elsewhere. I understand the cilantro vendor’s shipments are being stopped for testing, but I don’t know the details.

Both Will and the Pundit were quoted in the Washington Post in its piece Deconstructing Salsa In Search of Salmonella. In that article, Will pointed out that the product was losing value due to FDA quarantine:

Chile pepper importers said they are already feeling the effects of the FDA’s scrutiny of jalapenos. “I have two full truckloads of jalapenos in my building quarantined because FDA is holding it awaiting analysis,” said Will Steele, president and chief executive of Frontera Produce in Edinburg, Tex. “That was as of last Monday, and there are still no results. The salability of that produce in two to three days is gone.”

While we pointed out the irresponsibility of FDA’s conduct:

“We all put public health first, but you don’t casually crush an industry, deprive poor migrant workers of their pay, bankrupt farmers, have consumers throw out food — without triple-checking all these things,” said Jim Prevor, author of the industry blog the Perishable Pundit.

And in his conversation here, Will’s story makes three emphatic points:

1. Why in the world should the FDA add uncertainty to the damage it causes business? Why should any business anywhere have to be calling local contacts to nudge some info from them? This is not a secret project that FDA could hope to conduct without anyone knowing. So it is not a matter of keeping the sample unsullied by public knowledge. This is just bad planning on the part of FDA.

2. Semantics aside, there are many ways to achieve one’s goal. If FDA really wanted information that sampling at the border would generate, it would encourage maximum volume by letting all shipments be sold even while it takes samples. One has to assume that FDA really wants to close the border but doesn’t have the evidence to win a WTO case against Mexico, so it creates uncertainty in the marketplace in order to achieve the same goal.

3. Why doesn’t FDA do with these new items what it did with tomatoes in creating a “pass” list for regions that were not in production on April 10, 2008, when the first onset of illness had been identified? Once again, the FDA’s behavior is irrational.

Raul Cano
Grande Produce Ltd.
Hidalgo, Texas

Q: Have you been impacted by FDA’s expanded outbreak investigation?

A: We do carry those items and, of course, have been affected. Roma tomatoes were first and we got hit by that, and now it is peppers and cilantro. Randomly FDA is taking samples of tomatoes, jalapenos and cilantro. We don’t know how many items they’re going to inspect. They don’t have a system in place.

With tomatoes they inspected three loads and then we were cleared. It seems like a different system all together with jalapenos and cilantro. They stop as many loads as they want. Inspectors have gone to some of our customers to take samples. We’re afraid to bring any more loads in because we don’t know what happens. If they take samples we have to wait up to 14 days for results. Do you think that is logical or reasonable? There is no way product will last for that long. It’s silly.

Q: Are you still importing jalapenos or cilantro from Mexico? If so, what has happened to the loads?

A: We were bringing in cilantro and jalapenos as of [July 7]. We didn’t get inspected. They released the products and said we could sell them. But we’re going to stop all shipments because we can’t take the risk. We don’t know how long this will go on. Who knows when it won’t be a problem? Maybe FDA will decide the problem is no longer with salsa, but with guacamole and start to do limes and avocados. FDA is looking for contaminated jalapenos from three months ago.

Q: How are your customers reacting?

A: I had a customer call today. He said that tomatoes, cilantro and jalapenos from us that he sold to a restaurant were a problem because a person got sick after eating there. The inspectors took samples of the product and sent them to a lab and everything was fine. They didn’t find salmonella.

If my customer sold so many boxes of these items to restaurants and only one person got sick, yet all these other people were eating the same salsa, the same tomatoes, why did only one get sick? FDA keeps blaming tomatoes, and now cilantro and jalapenos going back to the growers. We should do a better job of investigating the people getting sick. For some reason, FDA is relating the outbreak to items used to make salsa. What if it’s the oil or chips? The FDA has no idea.

Q: How serious a blow is this to your company’s financial well-being? Will you be able to weather this storm?

A: The only reason why we continue doing business is because we sell a lot of items. If we stop selling tomatoes, cilantro and peppers, we are able to switch to other items. Many companies don’t have that option. The bills keep coming. If a company has to stop operations, it doesn’t matter whether that company is big or small, it can put them out of business.

Q: How do you balance the quest to protect public health when the outbreak lingers on?

A: If we look on the side of consumers, they want to be safe and that’s why FDA has to do all it can to make sure food is safe and good to eat. No one questions that, but FDA can do it a better way and in a more efficient way, while letting consumers know the truth. A lot of folks are losing a lot of money because of the way FDA has been conducting the investigation.

In America, if you arrest somebody, that person is innocent until proven guilty. FDA should not be saying the problem is tomatoes, cilantro or jalapenos when they have no proof. FDA is getting pressure from the media and the public. Sick people keep increasing, more than 900, and FDA feels they have to do something.

Q: Is this the first time you’ve had to deal with an outbreak like this?

A: We’ve been in operation since 2002. A year and a half ago, there was the Taco Bell outbreak, where Taco Bell falsely implicated green onions as the problem in an effort to make it go away. It turned out not to be green onions. And then the suspicion turned to lettuce. Everyone was freaked out and many people suffered.

To us the two key points are illustrated by this quote:

We’re afraid to bring any more loads in because we don’t know what happens. If they take samples, we have to wait up to 14 days for results. Do you think that is logical or reasonable? There is no way product will last for that long. It’s silly.

This makes the point that the FDA can destroy businesses and bankrupt people without ever banning anything — just raising the risk of doing business can often do the trick.

In America, if you arrest somebody, that person is innocent until proven guilty. FDA should not be saying the problem is tomatoes, cilantro or jalapenos when they have no proof.

This line speaks to the notion that this situation goes beyond food safety, to basic American conceptions of law and due process. In America, even for public use, you can’t take a man’s property without compensation. There is something profoundly un-American in the notion that for such feeble and hypothetical food safety gains, the government can just bankrupt people who have worked their lives to build a business.

Gilbert Ramirez
A&G Produce
Edinburg, Texas

Q: Tell us your experience.

A: FDA is going to check all shipments of cilantro and peppers. They’re checking all the loads. They say they’re going to check the product when they receive it in the U.S. I send it to my warehouse and put product on hold for at least six days; then after they get results back I can start selling. Maybe seven, eight, nine days later, they’ll call customs and my custom guy will let me know. The thing is I’m not going to bring in any cilantro under those guidelines. By the time I’m selling product, it’s decayed. Right now it’s already old. You can’t hold cilantro for a week. Cilantro has to move or it ends up in the trash.

I don’t have an issue with FDA checking shipments. Normally they check every load of cilantro for worms and other kinds of pests, but I can sell it. I can start selling right away.

Now this salmonella problem happens and first they blame the tomato, and then it’s not the tomato, so sorry to the growers who lost money, but it’s now cilantro and peppers. I don’t think people at the FDA know what they’re doing, but they want people to think they are doing something. That’s what’s wrong with the system. It’s unfair and biased.

Q: What do you mean by biased?

A: What happens for me is pretty bad. In Mexico the market will go down. On the American side, it will go up because no one will have cilantro from Mexico. People will turn to cilantro from California.

I don’t know what the motivation is for sure. All I know is that everyone is saying they want a better price for U.S. growers. They’re blaming Mexico for the salmonella outbreak even though they have no proof.

For our company, I told the guys who work for me, thank you very much, but I’m not going to have any product. I’m sorry, maybe it will last one month or two months like the tomatoes. I have eight people working for me. I’m going to close the doors for now.

Maybe I’ll bring in cabbage, but I don’t need that many people for that commodity. Jalapeno peppers and cilantro requires more labor. I just bought a nice $20,000 machine for the cilantro, and I have to make my payments. The equipment companies don’t care about what is happening to me because of the outbreak investigation. I’m getting called for payments on my machines.

It’s going to be tough for us, this thing. This is some kind of government action motivated by politics. Something is wrong here. I think politics matters. They try to tell people it’s only related to food safety. OK, no cilantro, no peppers, no this, no that. They don’t have any valid reason. I’m not an expert, but I’ve been in the produce industry 30 years. I’ve seen this several times where politics plays a part.

We’re a small company. I can’t afford to pay my employees. Right now I’m alone.

Gilbert’s story tells two key tales: First, it is not only farmers who get hurt by FDA’s actions. Think of the workers who get laid off, the salespeople who can’t sell machinery and equipment, the banks who finance that machinery, the local taxes that won’t be paid, etc. Second, the FDA’s conduct is reducing confidence in its decisions. Is it acting this way out of politics? Due to corruption? Who knows?

Surely nobody will ever think about FDA pronouncements with the same sense of certainty they may have once carried. That is a terrible loss from this Salmonella Saintpaul outbreak and not just for the FDA. If people become skeptical about the FDA, it means the FDA can’t help rebuild confidence in our products as it once could.

It can take a hundred years to build a reputation, a few minutes to lose one. The price of this outbreak is thus incalculable.

Many thanks to John McClung, Will Steele, Raul Cano and Gilbert Ramirez for taking some of their valuable time during this difficult period to share their experiences with the industry at large. We pray that all three of these gentleman and their organizations should be strengthened by their endurance of this crisis.

Special Edition X —
Salmonella Saintpaul Outbreak…
FDA’s Contempt For Industry
Causes Pain And Suffering

If The Industry Doesn’t Hang Together…Surely We Will All Hang Separately

The industry has pretty much come to the conclusion that something must be done. We simply can no longer allow situations in which the FDA causes industrywide dislocations — as it did in the spinach crisis of late-2006 and is now happening with the Salmonella Saintpaul outbreak, where first the tomato industry was crushed and now the FDA is marching through the “salsa bowl” crushing additional industries.

Our efforts are all to the good. We’ve spent some time brainstorming with some of the staffers on the Hill, and it is clear that thoughtful people are looking for ways to both enhance public health and avoid the ruin of whole industries.

We need, however, to take a principled approach. What is happening with tomatoes or on the Mexican border is not wrong just because a lot of people and large industries are being damaged. It is wrong because it violates import principles:

  1. On a prudential basis, it fails to measure the cost vs. the benefits of each action.

  2. On a management-procedures basis, it is wrong because of a lack of safeguards to protect against rash decision-making, the influence of corruption, etc.

  3. On a competence basis, it is wrong because the procedures followed — such as not doing a traceback on the control group — means the source is unlikely to be found.

  4. On a public-health basis, it is wrong because there has never been a finding that banning any particular item leads consumers to eat diets that are more likely to be healthy.

  5. On a resource-allocation basis, it is wrong because it expends enormous resources on very small problems. Lost in the smoke surrounding this crisis is this startling figure: CDC estimates that there are 1,412,498 cases of Salmonella in the US every year. One strongly suspects that if one’s goal is to improve public health, all the money spent on this effort could be reallocated more productively.

  6. On a food-safety basis, it is wrong because it undermines the whole preventative approach that we now know to be the only option when looking at increasing food safety. Treating both “gold standard” and “disinterested” farms equally requires buyers to use non-vetted sources and discourages future food safety investment.

  7. On a moral basis, it is wrong because in America we don’t use people as merely a means to an end. We do not follow some kind of utilitarian morality where it is OK to harm one person (or company) if it benefits two people. Individuals have to be individually punished for their individual transgressions in accordance with due process of law.

All these points indicate a massive need for reform of the essentially lawless discretion that FDA exercises.

If we are to have credibility as a player in this reformation of the government, we have to stand up for the individual farmer as much as for the whole tomato industry.

We’ve run a number of pieces on the situation faced by Agropecuaria Montelibano down in Honduras. Here we have an individual farm on which the FDA imposed an “Import Alert,” de facto banning their product from the United States.

Despite an extensive site visit and countless samples, FDA has never been able to definitively link this grower to Salmonella.

In fact, in what is just lawless behavior, the FDA and CDC went down to the farm, found nothing, then made a bunch of demands that are not made of other farmers — remove the telephone wire over a portion of the property, use only well water, not river water. As best we can tell, the FDA made these demands because it thinks it needs to demand changes. The river has tested negative, for example, and FDA has not urged a change to good agricultural practices to have farms avoid river water or telephone lines.

Yet even after the farm acquiesced, did everything asked, the FDA still will not lift the “Import Alert.” So, in effect, the FDA is asking a farmer to gamble millions of dollars and plant for next season with the hope — on a wing and a prayer — that the FDA won’t be too busy or won’t think up some new problem to be solved and will allow the product into the US.

Agrolibano is a gold-standard farm. Its product is accepted in the UK by companies such as Tesco, and the company has loads of third-party and customer audits.

The industry should not sit by and allow the FDA to crush an individual company for no reason.

Surely anyone watching the CDC and FDA through this Salmonella Saintpaul episode realizes that there is no place to hide… any company or industry could be next.

We shouldn’t make this company fight alone. The FDA should not have the discretionary power to destroy industries or companies.

We need to insist on justice for all — even a cantaloupe grower down in Honduras. Maybe had we fought harder, as an industry, against the arbitrary exercise of power there, the FDA would have been more hesitant to decimate the tomato industry now.

Special Edition X —
Salmonella Saintpaul Outbreak…
FDA’s Contempt For Industry
Causes Pain And Suffering

Consumer Watchdogs Ignore
Current Outbreak In Pursuit of Predetermined Agenda

The Center for Science in the Public Interest (CSPI) and the Consumer Federation of America (CFA) held a press conference issuing a statement headlined as Emergency Regs Needed for Tracking Produce, Food Groups Say.

The gist of their proposal is two-fold:

First, they issued an “urgent plea to Dr. Andrew von Eschenbach” who is the commissioner of the FDA, to issue an “emergency regulation” requiring “traceability for produce.”

Second, the groups also urged the agency to require growers and packers to have written food safety plans.

Caroline Smith DeWaal is the food safety director for the CSPI and she is an earnest, intelligent woman. She is knowledgeable and does a great press conference.

The problem here is that you have groups such as CSPI having goals that were established long before this outbreak and they attempt to use the news to buttress the case for things they want anyway.

We think Caroline wants to make food safer, so we would encourage her to look hard at this specific outbreak and see what can be learned.

The first and most obvious thing is that whatever the problems may be with traceback, this outbreak indicates a problem with our public health system’s epidemiological efforts — not a problem with traceback.

At the very beginning of this outbreak, we published a piece by Jim Gorny, PhD, Executive Director, Postharvest Technology Research & Information Center, University of California, Davis, entitled Tomato/Salmonella Situation Cries For Improved Epidemiology, and he warned us that what slows these things down is epidemiology, not trace back.

Later we published an interview with Michael T. Osterholm, PhD, MPH, Director, Center for Infectious Disease Research and Policy, University of Minnesota, entitled Dr. Michael Osterholm, Esteemed Authority On Public Health, Speaks Frankly About The FDA, The CDC And The Incompetent Management Of The Salmonella Saintpaul Tomato Outbreak Investigation. In this article, Dr. Osterholm very clearly said that the CDC efforts on this matter have been inept and that they were unlikely to find the source BECAUSE OF THEIR INEPTNESS, specifically their failure to trace back the control group.

Traceback only comes into play after epidemiology is done identifying the items implicated. If epidemiology doesn’t tell us whether it is cilantro, tomatoes, jalapenos, Serrano peppers, tortillas or premade salsa — a direct video hookup to the farmer installed on every produce item won’t help solve the outbreak.

As far as having a written food safety plan, we don’t know any large, mainstream operators who do not. Somehow we suspect that CSPI’s earnestness on all these issues will falter when they learn that the practical effect of demanding all these things will drive small organic growers, Amish farmers, etc., out of business.

Be that as it may, we don’t see requiring a food safety plan as an issue, but find the call to be begging the question: What should be in such a plan, who should write it? Must it be certified? By what party? Where do they want the plans held?

Once again, it is basically impossible to be a mainstream grower selling to McDonald’s, Costco, Wal-Mart, Sysco, etc., without being audited numerous times both by third-party auditors and by customers — and you can’t be audited without written plans to audit against.

So this call by the CSPI is odd. The only practical consequence would be to smother tiny growers with expenses they couldn’t handle. It is highly predictable that should such a regulation ever be considered, the organic groups and others will call for an exemption based on small size and get it. So the practical effect of this regulation would be to say that everyone who already has a written food safety plan would have to spend money on “certifying” it in some way.

Net, net, net — there would be no increase in food safety, just another lawyer’s cash cow.

It is very hard to make progress on food safety if the players don’t really look at each outbreak to see what we can learn from it. This one teaches us that changes are needed at CDC and FDA, and that should have been the focus of the CSPI and CFA statement.

Special Edition X — Salmonella Saintpaul Outbreak… FDA’s Contempt For Industry Causes Pain And Suffering

FDA Communications
Lack Vital Risk Assessments

Dr. David Acheson, FDA’s Associate Commissioner for Foods, made a statement during the conference on July 9, 2008, that indicates he doesn’t really understand what the complaint is with the way the FDA releases information:

If we feel we have got strong enough evidence to warn consumers about a product that may be contaminated with salmonella. It is our job to do that. Not to go out too soon, we have to be sure. And not to “point the finger,” so to speak, at different products without good evidence. But I can assure you there was good evidence. And that is why we went down that road.

Now I recognize that there are consequences to this. But as you have heard, tomatoes are still part of the investigation. And there are plausible explanations why this could have been two products shifting from one to another.

The FDA works for the people, and we know of nobody, literally nobody, who thinks the FDA should not tell people what it knows. If Dr. Acheson thinks the issue is that the industry wants FDA secrecy, he is mistaken.

Everything, though, is a matter of perspective.

For every numerator, there is a denominator and to say something is “dangerous” is not giving consumers actionable information. We are sure there are wonderful statisticians who work for the government and can help the FDA. When a statement is issued, it should contain ALL THE RELEVENT INFORMATION the government has.

So, a typical announcement should be phrased something like this:

“The epidemiology team at CDC is 80% confident that fresh widgets now in the distribution chain may be contaminated with Salmonella Saintpaul.

Over the last five years, there have been seven outbreaks associated with Salmonella and fresh widgets. On average those outbreaks resulted in XX illnesses, X hospitalizations and no deaths. Research done by CDC indicates that for every known sick person, there are over 30 people who get sick but are never counted in the government statistics, principally because they were less serious illnesses and the people did not pursue medical care.

If this outbreak were to be an average one, and we have no reason to suspect otherwise, we would estimate the likelihood of an average American needing to be hospitalized as a result of consumption of fresh widgets to be .XXXXXX%.”

In other words, we all take on risks. There are 45,000 people who die in car accidents every year and yet people drive cars. By telling us fully what the FDA knows, it can help people decide what risks they wish to run.

The problem with the FDA is that it never wants to quantify risk. This may be because few people would pay attention to an effort to get them to avoid an infinitesimal risk.

Perishable Thoughts

Perhaps as industry anger over the progress of the investigation of Salmonella Saintpaul boils over, all of us need to remember words that Theodore Roosevelt wrote in a book entitled, The Strenuous Life.

The title came from a speech he gave as the Governor of New York when he spoke on April 10, 1899, in Chicago where he had been invited to address the Hamilton Club.

Basically the argument of public health authorities is that they are allowed to destroy industries and bankrupt the innocent in order to protect public health. But Theodore Roosevelt had another perspective:

No man is justified in doing evil on the grounds of expediency.

— Theodore Roosevelt
26th President of the United States (1858-1919)
The Strenuous Life: Essays and Addresses (1900)

Perishable Thoughts is a new section of the Pundit, which we announced here. We hope you will send us your favorite quotations to be included in this section. You can do so here.

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