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Perishable Pundit
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Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

FDA And CDC Create DoubtsAbout Their Own Competence …
As Well As The Tomato Link!

On Friday, June 27, 2008 one of the most shocking press conferences of the whole Salmonella Saintpaul outbreak occurred. We felt the need to come out with this special Saturday edition of the Perishable Pundit to deal with the implications of this press conference.

It is clear that there is a breakdown — an almost complete collapse of public health competence at the highest levels of our government. If we don’t fix this we will both endanger the public health and create a business environment so subject to the random whims of government officials that people and businesses will be loathe to invest, provide jobs and feed the planet.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

CDC Back Pedals Fast As Dr. Griffin Tries To Re-write History To Avoid Responsibility For Her Actions — Or Lack Thereof

Q: Is there now a question that tomatoes may not actually be the incubator of the salmonella? That it might be some other type of produce?

A: We continue to see a strong association with consumption of tomatoes and from the start what we said is that many of the people ate tomatoes in dishes such as salsa and guacamole so that we have always been looking both at tomatoes and at exposure to other ingredients in the dishes…

…we continue to keep an open mind as to the possible source of these outbreaks as does FDA.

The above exchange between Tiffany Hsu, a staff writer for the Los Angeles Times and Dr. Patricia Griffin, CDC’s Chief of the Enteric Diseases Epidemiology Branch, is positively shocking.

Let us look at what CDC actually said:

Initially, on June 2 2008, the CDC was relying on the work of others and made that clear in its pronouncement…

An epidemiologic investigation conducted by the New Mexico and Texas Departments of Health and the Indian Health Service using interviews comparing foods eaten by ill and well persons has identified consumption of raw tomatoes as the likely source of the illnesses in New Mexico and Texas. The specific type and source of tomatoes are under investigation; however, preliminary data suggest that large tomatoes, including Roma and red round are the source.

But by June 12, 2008, CDC started issuing the statements under its own name, without qualification:

An epidemiologic investigation comparing foods eaten by ill and well persons has identified consumption of raw tomatoes as the likely source of the illnesses. The specific type and source of tomatoes is under investigation; however, the data suggest that illnesses are linked to consumption of raw red plum, red Roma, and round red tomatoes, and products containing these raw tomatoes.

If this wasn’t enough to establish that CDC had determined that there was a tomato linkage to the illness, the CDC statement went on to say this:

Only 3 persons infected with this strain of Salmonella Saintpaul were identified in the country during the same period in 2007. The previous rarity of this strain and the distribution of illnesses in all U.S. regions suggest that the implicated tomatoes are distributed throughout much of the country.

Although there is a brief reference to “products containing these raw tomatoes,” the clear implication is that the products are a problem only because they contain the tomatoes.

This perception was clearly backed up by the FDA consumer advisories, which never said a word about not eating guacamole or salsa — only not eating products made with implicated tomatoes.

It really seemed that Dr. Griffin has been genuinely hesitant to pin this outbreak on tomatoes.

But now, she decides to speak out only after an industry has been crushed, its employees left poorer and with less certain futures, consumers have been scared to death and were led to throw out food at a time when food prices make the daily headlines. Her position at CDC requires not merely technical ability but political courage and she should have issued a statement early in the process saying that she was not convinced that it was tomatoes.

Now if they find it was not tomatoes, she will have to live her life knowing the damage she caused because she lacked the courage to speak up publicly for her convictions.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

FDA Does Damage Control While
Doctor Acheson Tries to Justify The Unjustifiable

While CDC ‘s story is surrealistic, the FDA has become positively delusional. Here is what Dr. David Acheson, MD, FDA’s Associate Commissioner for Foods, had to say in the same press conference where CDC started backtracking:

It isn’t over yet. We don’t have all the answers yet. This is all really designed in the context of trying to inform consumers about what we know and when we know it what we know and what we don’t. It is still a more constructive process than simply staying silent for two months and then coming out with “we don’t know the answer.”

Where does one start? With the obvious, of course. If this turns out not to be tomatoes, then the whole process was not, in fact, “constructive” at all. It would have been, in fact, enormously “destructive”.

Consumers threw out good food at a time of tight budgets, tomato farmers, packers, wholesalers, repackers, distributors and brokers suffered enormously. Some will go bankrupt. Employees, including migrant workers and poor Mexican harvesters, will have lost some or all of their livelihood.

And, of course, if it wasn’t tomatoes, then no public health benefit came from all the FDA recommendations — in fact public health suffered as a nutritious food was sometimes replaced by foods less nutritious.

So, yes, it would have been better to say nothing than give out incorrect information.

Besides, it is debating 101 that when you have a weak case, you create a false dichotomy. In this case, Dr. Acheson sets up the straw man as being either do exactly what he did or be completely silent. There is another choice… how about being honest?

Look, the FDA’s job is to enhance public health, not protect the produce industry, so the industry may not always be thrilled with FDA activities. That is OK.

But public health is not assisted by false certainty. In fact, the public health recommendations have cut off discussion and debate and the context Dr. Acheson references of to inform consumers about what we know and when we know it what we know and what we don’tsuddenly disappears.

The truth was probably something like this:

“We believe there is an 80% or better chance that fresh red round, red roma and red plum tomatoes are implicated in this outbreak. Because the outbreak started six weeks before this advisory, if the outbreak was based on a farm, it is 80% likely that it is already over and the only risk would be from tomatoes already in a home. In any case the risk is small.

Most healthy people, even if they get salmonella, become ill with a bad stomach ache and similar symptoms. There is greater risk for those with inadequate immune systems — small children, senior citizens, AID’s — patients those who have undergone chemotherapy or radiation treatment recently, etc. In any case, even a large outbreak poses relatively small risks for individuals. A hundred people hospitalized would be a very large salmonella outbreak, that is only .00000015737% of our 305 million population. We will continue our traceback efforts to both determine the cause of this problem and prevent future foodborne illnesses.”

A truthful presentation such as this would have actually been a basis for discussion. Instead the blanket recommendations not to eat products create a “killer tomato” scare not justified by the facts.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

CDC Rejects Internet Age…
Wants To Keep All Information Secret During The Outbreak So Nobody Can Question Its Decisions

Jonathan Rockoff of The Baltimore Sun pushed CDC hard on an issue we have been preaching: transparency. He kept asking the same question we asked here. Would the CDC post on its web site not just vague ranges such as “illnesses began between April 10 and June 13, 2008,” but instead release quantities that became ill on each day?

This is non-confidential information and would allow epidemiologists outside of the CDC to make their own judgments. Dr. Patricia Griffin, CDC’s Chief of the Enteric Diseases Epidemiology Branch, could come up with no reason not to do this except for repeating again and again that the data isn’t complete.

Of course, reviewing incomplete data is what everyone at CDC and FDA do every outbreak — it is just arrogance that makes Dr. Griffin think nobody else can be trusted to read incomplete data.

CDC and FDA are so backwards. The whole world is changing. Take a project such as Wikipedia, in which the collective knowledge of all the people who wish to contribute has created a pretty darn good encyclopedia — for free!

If these organizations were sincere about solving food safety outbreaks, they would make all non-confidential information public as soon as possible — then let the intelligence of the world pitch in to solve the riddle — at no cost to the government.

Instead, fearful of their prerogatives they try to hold back information and thus leave themselves alone to solve difficult problems.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

FDA “Learns” About Tomatoes

Another bizarre portion of the press conference… listening to Dr. David Acheson, MD, Associate Commissioner for Foods, talk about the things they learned about the tomato industry during the course of the investigation.

It reminded one of the old saying, “it is not what you don’t know that gets you in trouble, it is the things you know that aren’t so.”

Basically the FDA seems to have collected unusual happenings that account for infinitesimal parts of the industry — such as shipping Mexican tomatoes physically into the state of Florida so that Florida tomato packers can ship them on to their customers — and made such unimportant things important matters to worry about in the FDA’s traceback analysis.

So the FDA now claims to "know" a whole set of bizarre things: In addition to Mexican tomatoes being shipped to Florida, they "know" that perhaps 90% of tomatoes are repacked and that fields produce for months on end. It would be nice if they referenced a source for all this information they choose to confuse the public with.

Even odder, though, is that there is no indication anyone has ever done a tomato traceback before. Tomatoes, however, are on FDA’s list of high-risk produce items. One would think CDC and FDA would both be fully prepared for the complexities involved. FDA seems to start out each out break as a tabula rasa. It is inconceivable.

Besides, we talked about repacking here. It is far less an impediment to traceback than processing is. Yet they are making much of it. Perhaps they sense they will need an excuse for not finding the source of the problem.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

Thinking Outside The (Fresh Tomato) Box… So What Can The Problem Be?

We said right from the beginning… How could three separate chains of wildly varying size in the Las Cruces, New Mexico, area all buy from the same supplier? It just doesn’t happen that way with fresh tomatoes.

We hypothesized about the local managers buying outside the procurement system but that became impossible as the outbreak spread.

It cannot be a farm-based problem because there are no farms that were producing tomatoes both at the start and the latest onsets of illnesses in this outbreak.

It cannot be a repacking plant. There is no one large national repacker that takes in tomatoes and redistributes them from California to New York. Repacking is a local and regional game.

Which makes us think that CDC and FDA may be barking up the wrong tree. The only fresh products with broad distribution and a tomato element would be fresh refrigerated salsas, such as are occasionally sold in produce departments but typically sold in the deli department.

In salsa, tomatoes are usually the #1 ingredient, preserved with citric acid and calcium chloride. These products fit the outbreak:

1. Contain tomatoes

2. Preservative and refrigeration gives a long shelf life

3. Made in a factory that could be a plausible source of continuing contamination

4. Sold both in retail and foodservice packs and thus both sold to consumers and used by restaurants

5. Broad distribution from one production plant

Despite what the FDA and CDC say — if there is only one outbreak and if it is caused by a farm-level condition — the outbreak must be over.

We’re not sure why it must be produce — few people eat salsa or guacamole without chips or tortillas, but if it is a fresh product with tomatoes we would look for fresh salsa or Pico de Gallo sold occasionally in produce, often in deli and frequently to foodservice.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

Can We Avoid This Mess In The Future?

There are two separate but related issues here: The first is how to structure an investigation to be more effective. Our interview with Dr. Michael T. Osterholm, pioneer in the investigation outbreaks in produce, made that clear:

  1. We need a defined chain of command. Right now, CDC passes the ball to FDA, which passes it back and they both blame the state health departments — or hesitate to when they should place blame on the states. You can’t run an outbreak investigation by committee.
  2. Control cases must be traced back. It is now clear, even to a layman, that it is not sufficient to trace back the cases of ill people alone on complicated bulk product outbreaks. Only case/control traceback — meaning traceback both of the tomatoes reported purchased by sick people and well people — will produce a picture of the outbreak with sufficient clarity to rapidly “solve” an outbreak.
  3. Stop hoarding information. The CDC can’t do this all itself. There are many intelligent people who can contribute to this process if they are given the data to do so. Posting on its web site simple data such as how many people have, so far, reported each event such as the date of onset of their illness, would be very valuable.
  4. Engage with the industry. The “Not associated with this outbreak” list was a good idea but was ruined by FDA’s ad hoc method of producing the list, which placed the onus on growers to beg their politicians to plead their case before FDA.
  5. Emphasize the mathematical risks. Every time CDC mentions a numerator — 50 people hospitalized, it must mention a denominator — out of a population of 305 million. When talking about risk, it would be helpful to make comparisons that consumers could relate to. Just as a good writer will write that the ship is 300 yards long, the length of three football fields, so that a reader can conceptualize the distance, CDC and FDA have a responsibility rather than just screaming “danger, danger” to put that danger in perspective. How do the risks compare with getting hit by lightening or being in a car accident?

The second issue that needs to be addressed is the need to make sure CDC and FDA have some checks and balances before they destroy an industry and make consumers spend hundreds of millions of dollars replacing food. A few key ideas:

  1. Decisions must be signed. People must be held responsible for their mistakes. In other words, you want at least three epidemiologists to sign a statement saying that with a high degree of confidence they can state that product XX or company X is the cause of an outbreak. There has to be a downside to these people for being wrong.
  2. Every outbreak should have a ”Team B”. Team B was an exercise in competitive analysis conducted by the CIA under its then-Director, George H. W. Bush. The idea was that every time the CIA analysts came up with an intelligence estimate regarding the Soviet Union, a group of outside intelligence experts were brought in to challenge the CIA’s internal analysts — though the question of who was right remains controversial to this day. The very fact that CIA analysts knew that their opinions would be challenged probably improved the quality of their analysis. Before the FDA issues recommendations, we need to make sure those recommendations have been challenged by competent personnel.
  3. The ”Zero Tolerence” standard must be junked. If we could test every single tomato, cantaloupe or other item, we would probably find some baseline level of Salmonella out there. This means that this is part of life and not a cause for hysteria. The FDA needs to establish realistic baselines that we can then work to improve year by year. To simply pretend pathogens don’t exist, ever, in products grown in the dirt, rained on and in contact with man and beast makes FDA irrelevant rather than a partner in advancing food safety.
  4. Recommendations should only be issued after a finding that it will enhance public health. During our discussions of the Honduras Cantaloupe situation, we pointed out that the farm implicated was a top quality, fully certified one. We questioned the logic of banning their product from America while allowing the completely unaudited farm next door to ship freely. Equally, in this tomato outbreak, we pointed out that many buyers who had cultivated food safety partnerships had to abandon their fully vetted sources and buy from strangers. We questioned how this could possibly help enhance public health. Before they issue a recommendation or import alert or anything that blocks product, FDA should be required to issue a finding that the alternatives available will be more likely to be safe.
  5. Give credit for food safety efforts. One of the saddest parts of all this is that its mode of operating discourages investments in food safety. As we discussed here, FDA cannot treat equally the grower who is fully certified by customers and third parties as one that does nothing to enhance food safety. Perhaps FDA should establish its own food safety standards for growers. Those growers that are third-party audited to the standard FDA approves by auditors FDA has approved would be deemed "innocent" in the absence of specific evidence implicating those growers. These massive bans and recommendations should only apply to unaudited product.

These are ten specific changes that need to be made. What the industry should call for is a formal investigation of this outbreak with the goal being the production of a report urging these and other necessary changes in the outbreak management and public health system.




Special Edition VIII —
Salmonella Saintpaul Outbreak
Takes Another Bizarre Turn

Why Have FDA And CDC Changed Their Tune? Perhaps They Read The Pundit’s Interview With Dr. Michael T. Osterholm

We don’t think it is a coincidence that the FDA and CDC started backtracking right after Dr. Michael T. Osterholm, a well-respected epidemiologist spoke out about the incompetence of the traceback.

He was particularly pointed about CDC’s failure to do a traceback on the control group — which is the non-sick people who had been questioned.

The interview is powerful. To make sure everyone had a chance to read it, we will re-run it in its entirety below:

Dr. Michael Osterholm, Ph.D., M.P.H.
Director, Center for
Infectious Disease Research
and Policy, University of Minnesota

Q: What is your assessment of the tomato outbreak and FDA’s handling of the investigation?

A: One thing to help set the tone for this interview… Our group in Minnesota from 1975 to 1999 pioneered a lot of techniques used in outbreak investigations today. These techniques have led probes into many national outbreaks. We’ve been very involved in many national outbreak investigations, and I’ve published numerous reports analyzing the issues.

Q: Why is this outbreak investigation dragging on so long?

A: First of all, there is a common misunderstanding about how outbreaks get identified and evaluated in this country. Josiah Stamp, a famous British statistician, once said government statisticians are keen on amassing statistics. They add them, divide them, take the cube route and make wonderful diagrams. But you must never forget those statistics come from the village watchman and he puts down whatever he damn pleases.

In the first instance, all infectious disease is local and only as good as local surveillance. Fortunately, we’ve had states such as Minnesota, Oregon and Tennessee that have really been on the cutting edge of detecting outbreaks because of very good surveillance. Local and state surveillance only works when health laboratories are equipped with the capacity to quickly characterize the bacterial isolates from these patients.

For many states in the country, they do not have that kind of support. So you actually have cases either not getting reported to state and local departments or isolates not obtained, or they’re not characterized or fingerprinted until months after the outbreak is already over.

Q: Is this what happened with the tomato outbreak investigation? In the case of a highly perishable product such as produce, couldn’t the time lag alone be the nail in the coffin of an effective investigation to stop further illnesses?

A: An old case is categorized as two or three weeks ago in the produce world. Because outbreaks come out so quickly, you run into a phenomenon of many mini outbreaks. Perishable items are available 365 days a year, but on any one day where they’re coming from is a very short-lived event, maybe a crop is harvesting from one particular field for couple of weeks.

By the time we identify the food item, it’s already through the system. The timing of the public health response is critical to prevent any additional cases from occurring. If you don’t have a strong state and local health system, you’re trying to close the barn door after the cow is already out. State health departments will continue to be a problem as long as they are poorly resourced.

Q: In this case particularly, where did the system break down? New Mexico seamed to be quite aggressive and much more forthcoming in releasing details of its investigation.

A: New Mexico did a great job in this outbreak. On the whole, Minnesota, Oregon and Tennessee have led the way. The problem is that many states are not geared up to respond. In this outbreak, scores of cases are six weeks old or so. In Texas, many of the “new” cases are not new at all. The Texas Public Health Department is finally catching up in the lab with isolate characterization. The state only has two labs for this kind of fingerprinting.

By nature it’s slow. Imagine if every time you had a fire in the community you had to purchase a truck, get it inspected and do an oil change. Right there you have a problem.

Q: How does information from state and local levels flow to and between the federal agencies?

A: The whole system is flawed. The relationship between FDA and CDC is strained; it’s improved but still lacking. It’s not clear who is really in charge. Authority is split up in a way that decisions get bogged down and you don’t have anyone in command. You need that to effectively launch and oversee an outbreak investigation. I’m not sure who’s in charge. We have people identified as being in charge. We need someone that understands outbreaks, not just manages them. In this case, it appears that instead of experienced professionals, Outbreak Investigation Class 101 was doing the control study.

Also the influx of information from state and local authorities to CDC and FDA at best is very rocky, often not timely, and often not complete. Not getting isolate information for a case until weeks after the onset of the illness means it can’t be included or it is not included.

Q: FDA and CDC continue to report “new” cases piling in week after week, calling the outbreak “ongoing” with the numbers of illnesses appearing to escalate over time. Are you saying these are actually old cases slogging their way through the system? And if so, isn’t the manner in which FDA and CDC are releasing this information a gross misrepresentation of the state of the outbreak and current risk to the public?

A: This is a bit hard for me to address because I come from a public health world, 33 years now; the point being many of the people at the state and federal level are friends and colleagues. When I was at the Minnesota Department of Health, we pushed on these issues. I owe it to the public health of this country to come forward with my knowledge and put on the record the dysfunction occurring at the federal level. A subsequent review by experts in food borne disease investigations would say this tomato outbreak investigation has bordered on incompetence.

Q: In what ways exactly?

A: First, it is not biologically plausible to have Mexico and Florida both at the source of this outbreak. It epitomizes the ineptitude of the investigation. FDA and CDC should have obtained tomato product consumption information from both outbreak cases and controls. They needed to conduct full fledged tracebacks all the way back to the source not only of the sick cases but of the control group as well.

The epidemiology conducted to learn what product is associated with this outbreak by interviewing those sick and those not sick on what they were eating is a prerequisite but the epidemiology needed to go further. It was critical for the investigators to learn the locations of where both the cases and controls ate tomatoes and trace back from there.

When doing the traceback, you may come up with a few possibilities of where the tomatoes came from. If you collect data over time of the cases and controls, using the same methods to make the product association, you may find 85 percent of outbreak cases trace back to a certain field or grower, or re-packer versus the control product. Then you begin to get a much better handle on where product came from.

Q: Why did the government forego this strategy?

A: FDA and CDC have not made this a priority. They will never find a silver bullet by just tracing back a product. They’re looking for a cluster that matches up exactly with the one gun barrel. They’re under the false impression that they’re going to get a clean, clear-cut answer by finding the magic cluster. They need to do this case/control approach.

Q: Could you define these terms?

A: Cases are those ill with the specific strain identified with their food consumption. The control group is matched with age, similar characteristics and geographic location, the same neighborhood, for example. The cases might have a 10-fold chance of getting sick on tomatoes compared to the control group.

Q: Is this case/control approach more effective in some outbreaks than others?

A: In this outbreak identification for tomatoes, it needed to be approached differently than the spinach investigation. When looking at bagged lettuce or spinach, you have the advantage of a barcode with very good specific information that can take you back to a field. With a product like tomatoes or cantaloupe, you don’t have a barcode, and product is further mixed and matched in packaging and repacking.

Tomatoes have a vibrant lifecycle. A harvest today may go to a primary source today, but a week later may go to secondary channel. In other tomato outbreaks I’ve studied, prime tomatoes were first shipped to key grocery stores, then, as the crop aged, they were shipped to different classes of trade. The same tomatoes, with the passage of time, can wind up in supermarket chains, restaurant chains, convenience stores, mom & pop restaurants, wholesalers, processors, etc. All the tomatoes, though, were harvested at the same time. If you don’t understand that and try and trace back, the investigation can get very confused, which is clearly illustrated in this case.

Q: Didn’t the original epidemiological investigation of New Mexico and Texas cases include a control group as well?

A: The case control study initiated by New Mexico was important and did provide critical information. It used interviews comparing foods eaten by ill and well persons to identify consumption of raw tomatoes as the likely source of the illnesses. I believe New Mexico did try to do some trace back to the source but didn’t have the information or authority to go all the way back to Mexico.

New Mexico should be applauded for what they did relative to what they could do. CDC supports the overall epidemiological investigation. I know for a fact, however, that the government did not trace back any product reported by the control group. We don’t have a traceback to the source using the information from the control group. That was not done.

You would need to check with New Mexico to see if they did any further work with the control group on where they ate the tomatoes. [Editor’s Note: According to Deborah Busmeyer, spokesperson for the New Mexico Department of Health, “The purpose of the case control study was to identify a hypothesis of what the food source was, and from that we determined it was tomatoes. Then we looked at single source exposure in the cases, and that’s how we were able to trace back to particular stores. At that point, we went to talk with the stores about where they got their tomatoes. With Wal-Mart it became more complicated because they had two sources, either Florida or Mexico. With Lowe’s and Bashas, it was Mexico.

With those two stores, we were able to go down the supply chain to determine the distributor. At that point it was really pointing to Mexico and we passed that information on to the FDA and CDC, but we really don’t have the ability to go into Mexico. The case control was more to determine the product. I don’t believe there was a trace back of the control group. New Mexico is realizing that the FDA is the lead in these kinds of issues. We’re realizing inadequacies in the state system to provide those tasks. We got on top of this quickly, but we have limitations as well and that has been frustrating to us.”]

Q: What is your explanation for the latest onset of illness extending now to June 11?

A: You could have tomatoes through the system that long if you look at the normal growing season. We still don’t know the mechanisms behind the contamination. It could be contaminated water in a washing area and it is plausible tomatoes continued to go through that. Potentially the problem could be with a re-packer or region or irrigation source.

To narrow down the problem, it was paramount for FDA to obtain the same standard of completeness in investigating product from the control product group. Where did you eat tomatoes, at a restaurant, a grocery store, then you trace those channels back. All those factors should be known for both control and case. You learn it would be 15 times more likely to eat a tomato from this place, than the control. Now all you get is what appears to be inconsistent information.

Q: You place much weight on the importance of the control group. Was this the ultimate undoing of the investigation?

A: FDA never talked about tracing back product from the control group. It was a near fatal flaw from the get-go, and if they don’t change their approach they will never find the source.

The second problem — all cases with tomatoes typically have only lasted about 6 weeks. Any growing region of the world pretty much exhausts the product in that time frame.

This is not like a factory where every day widgets go through it. When you harvest that entire area, it’s done. Even if the product goes to a re-packer, if the onset of illness started mid April, even by end of May it’s pretty much the end of system. .

Yet here we are almost to the end of June. There are all these old cases in the system and the Health Department has done little to correct this.

Look at the curve. Reporting the most recent onset of illness is as late as June 11 is dramatically different than saying the outbreak is still going on. In the case of a tomato outbreak, you won’t have an ongoing continued source of contamination that goes on and on and on. Even if you look at the spinach outbreak, it’s not like the peanut butter outbreak, where leaking contaminated pipes would result in continued product contamination as long as that plant was producing without fixing the problem.

The FDA has done a very poor job of helping the public understand how outbreaks in the produce industry occur. No one can say with certainty when this tomato outbreak ended. But there is overwhelmingly strong evidence this outbreak peaked many weeks ago.

Look at the re-washing scenario. Product production shifts and moves to another part of the country. Look at past outbreaks. These outbreaks end on their own. They were over by the time we figured out what the problem was, if we figured out the problem at all.

If FDA and CDC took Mexico and Florida cases and worked the controls, I think this would have traced back to Mexico a long time ago. It was a flawed investigation. Why were some people getting sick and others not? They needed the control group to get to the answer.

The other problem is faulty analysis from mixing early and late cases. You may very well also be confusing the source of those tomatoes because tomatoes when first harvested may go to one area. For other buyers of the tomatoes, it may depend on the ripeness of where and when they’re sold, and that hasn’t been accounted for.

Q: A lot of this information on harvest cycles and distribution is readily available through produce industry executives. Isn’t this produce 101?

A: The final piece on this outbreak debacle: several of us have done a lot of work on outbreaks. We went to a wise group in the produce industry with no horse in the race. They looked at the patterns and they knew this market so well. This simple task of eliciting help from industry experts was not done by the investigators to any meaningful extent. We do very a poor job of bringing in the industry to help solve these outbreaks. What does this mean? That straightforward questioning didn’t happen in a way that would have been most helpful.

Q: Doesn’t this apply to the infamous FDA-approved source list? If the list was based on growing areas that were not in production at the time of the outbreak, wouldn’t that just involve a phone call or two to the produce trade organizations?

A: Right from the get-go, it was unclear how FDA was coming up with that list; why certain states and countries made the list while others were excluded. If any place not producing in late-April/early-May is safe, why the confusion and piecemeal additions to the list day by day? It appeared there was no rhyme or reason why a state or country was on the list. The logic was lacking. If FDA believed states and countries not in production at time of the outbreak were safe, they should have included all states and countries in that category.

On the other hand, if FDA has the view that a re-packer could be involved, which it now says it does, then it means FDA’s list would have been invalid and in their view putting consumers at risk. Either way, it’s not based in logic. Is it by dates of production, or is it not by dates of production because product could come through a re-packer?

There is a major issue with transparency. Why would you say something is or isn’t involved? First, the formation of the FDA list is disingenuous. It was based on those that screamed the loudest, and from a public health standpoint, that’s not right.

Q: What steps do you recommend at this juncture?

A: We need a serious examination of how this outbreak was handled from the first instance of illness. By the time tomatoes were identified, it was the end of May and the vast majority of product was through the food system already.

Another area that must be addressed is the poor job that’s been done in defining the risk.

As the Perishable Pundit pointed out so aptly, in a 40-day period, the public consumed three billion servings of tomatoes. We need to provide a better perspective. I don’t see anyone putting this in context. I’ve spent my career trying to understand and stop outbreaks, and I in no way want to minimize the dangers attached to an outbreak. This comes from a pioneer on getting outbreaks on the map. I gave a talk in 1988 that produce would face problems with outbreaks, and I was laughed off the stage.

The media has been just as guilty by not better defining the risk and through sensational and often inaccurate reporting has magnified the problem. Lou Dobbs, for example, doesn’t have a clue what he’s saying on this tomato outbreak and it doesn’t lead to solutions that are helpful. The risk of getting Salmonella from these tomatoes speaks to the safety of produce. What we don’t read about is how many times we don’t have outbreaks. Whatever the number of illnesses turns out to be in any outbreak — 400, 4,000, 14,000, 24,000 — that sounds terrible and it is not a good thing for a nyone to be sick. But we’re so fixated on the numerator we never talk about the denominators.

The take-home messages are that the food borne investigation system is flawed. This outbreak was inherently flawed from the beginning. New Mexico deserves credit, but the lack of state and local lab capacity and data collection and integration at the federal level can bring the industry to its knees. We must clarify risk.

Timeliness is everything. We must question how many cases we could have prevented through our public health action as opposed to those old cases in the works after the warning went out. If we’re four to six weeks into the outbreak, the cow is already out of the barn. For the FDA to then shut the barn door with all the authority of Public Health behind it, does it make any difference what we’re doing in the name of food safety?

Q: Could you address industry concerns that no matter how diligent a company is in implementing the highest food safety standards, when an outbreak occurs, it seems all companies are reduced to the lowest common denominator in the government’s eyes?

A: We clearly hurt the industry. The way we have healthy measures is to have a healthy industry. Our job is to work with people. If the industry is heavily stressed financially, they’ll have no option but to take shortcuts and cut corners. You want a viable, profitable industry that has the resources to invest in food safety. If every time we have an outbreak, the entire industry is implicated and takes a big hit. It doesn’t do anything to help industry invest in food safety. The industry is still suffering on post outbreak debate and discussion. Again, my interest is not to protect the industry; but a financially strong industry is part of the way to get viable public health.

The industry also needs to be part of the solution. Of course, “March of the Killer Tomato” makes for great news media but doesn’t help consumers. I’ve seen operators in the food service industry eliminate all tomatoes from the menus questioning the safety of the entire category when areas had been cleared. That is a copout. No tomato or any produce item can ever be 100 percent guaranteed safe. This is a time when retailers and food service operators should be going out of their way to support their suppliers.

Public Health would be faulted if the outbreak was still ongoing and it allowed contaminated product on the market. But what we can do is pinpoint the source a lot faster and stop the spigot there. Even if we don’t understand how the contamination happened, at least you identify where it came from. We don’t have that priority on speed and efficiency. I see the problem as a combination of lack of leadership and lack of understanding of how to work these outbreaks.

Q: Did you catch any of the FDA/CDC press briefings? The information relayed was often fraught with ambiguity. And reporters seemed to have a difficult time getting clarity.

A: A lot of people in the media are not experts in health or produce industry matters. Their coverage is often sensational, incomplete and tends to miss the overall perspective.

I read transcripts of the press conferences and I believe that the media did a poor job of holding FDA’s feet to the fire. The level of questioning has been very soft. They need to provide the checks and balances. I was particularly saddened when I heard the traumatic news that Tim Russert had died. I’ve always been a fan of his. He asked the hard questions. No one should have a free pass. It’s not about ‘Gotcha’ either; it’s just about trying to do the best job possible. We either take a political view or do nothing and go on to the next one.

I also wondered why the industry wasn’t pounding away with its own questions.

Industry often takes a back seat, in some ways like the Stockholm Syndrome. We all need to be held accountable for our actions.

This outbreak investigation has failed miserably. I’ve talked to many people about this in both state and federal agencies. There should be a call for a formal investigation on what happened and why. I really believe this outbreak is virtually over. The point is not to go back and punish people. The point is to learn so this doesn’t happen again. Outbreak investigations are not just to prevent cases during that time but into the future.

Q: Due to the nature of produce outbreaks, some industry executives think likening the goal of finding the exact source of an outbreak to the Holy Grail is over-glorified. Not only is it unlikely in most cases, but also unlikely to be the true salvation to fixing food safety problems in our industry. Do you have examples through your work where discovering the source of the problem led to corrective actions alleviating future outbreaks?

A: A large Salmonella outbreak in ice cream centered on a home delivery system in Minnesota. It turned out the trucks were hauling back raw egg to the plant and then contaminating the pasteurized ice cream. Lysteria in ball park franks in the 1990s was traced back to an environment where Lysteria was dripping from ceilings and creating condensation. Another outbreak investigation in the beef industry found that a new process in meat packing resulted in people eating thyroid glands mixed into hamburger, and people developing this horrible thyroid disease. Neck trimming is now banned. .

Q: Do you have an examples related to produce outbreaks?

A: No unfortunately. There are inherent risks with fresh raw produce; this is a risky business with the interface with nature. When FDA can’t find the smoking gun in an outbreak, it tries to find logical things to fix. But, of course, those fixes centered on the particular outbreak would need to be applied across the board if they are logical and based on science.

Clearly one of the options for the produce industry at this point is irradiation. Look at what’s been done with pasteurizing almonds. A lot of work needs to be done in this area. But in the end it’s a very important food safety solution for the produce industry

The whole reason I’m heading up the Fresh Express research mission is to find out what we can learn to take back to the production area to make a difference in food safety. I’m not speaking for Fresh Express here, but I use this example only to make a point as it relates to food safety in this industry. Here’s a company that in 25 years has never been implicated in an outbreak and has a very high percentage of the market. Negative data is a powerful tool. We get these high visibility outbreak investigations that result in limited public health and safety, but take up a lot of our time and get a lot of publicity.

The FDA and CDC folks already know I’m going public with these views and they have to get their ship turned around. I can walk into the mouth of the lion and say what I say because I worked there. Being out there to speak the truth on these issues isn’t always the easiest thing to do, but when public safety is at risk there is no alternative.

We are most appreciative of Dr. Osterholm’s willingness to discuss these matters in a frank and open way. We will never do better if everyone who really understands the issue is unwilling to speak, so all who want to enhance public health in America owe a debt to Dr. Osterholm.

As we read the interview, we draw a few key points:

1) Local and state surveillance only works when health laboratories are equipped with the capacity to quickly characterize the bacterial isolates from these patients. For many states in the country, they do not have that kind of support.

As we mentioned here, the focus on the FDA and CDC can be excessive. The prerequisite to effective dealing with food safety is on the state level. We need to look at benchmarking all the state labs and initiating a coalition to bring the bottom up to world-class standards.

2) …on any one day, where they’re coming from is a very short-lived event, maybe a crop is harvesting from one particular field for couple of weeks. By the time we identify the food item, it’s already through the system.

We have to break FDA from its superhero mentality. If it can protect public health, more power to it. But you don’t bankrupt an industry, have poor people throw away healthy food, just to say you’ve done something. Today is the 24th of June, the outbreak started in early April — there cannot be an “ongoing” outbreak on a national scale. The FDA should say so.

3) State health departments will continue to be a problem as long as they are poorly resourced… The Texas Public Health Department is finally catching up in the lab with isolate characterization. The state only has two labs for this kind of fingerprinting.

What Dr. Osterholm does not say, but is the logical implication of his comments, is that CDC needs to use these opportunities when the public is listening to point out the problems at the state laboratories. Instead of blandly explaining, as if it is dictated by some force of nature, that Texas is turning up month-old cases, the CDC should clearly and specifically state that Texas has inadequate lab capacity and this whole thing would go much faster — and we might actually be able to act while it helps someone — if the states would adequately invest in public health.

4) The relationship between FDA and CDC is strained; it’s improved but still lacking. . It’s not clear who is really in charge. Authority is split up in a way that decisions get bogged down and you don’t have anyone in command. You need that to effectively launch and oversee an outbreak investigation.

I’m not sure who’s in charge. We have people identified as being in charge. We need someone who understands outbreaks, not just manages them. In this case it appears that instead of experienced professionals, Outbreak Investigation Class 101 was doing the control study.

We need people to be in charge so we can hold them accountable for their decisions. This whole structure has to be reassessed. How can we make sure one person is in charge and he or she is really an expert? One wonders how many people involved in this decision-making process were actually familiar with the role of case/control traceback in prior Salmonella/Tomato investigations?

5) Also the influx of information from state and local authorities to CDC and FDA at best is very rocky, often not timely, and often not complete. Not getting isolate information for a case until weeks after the onset of the illness means it can’t be included or it is not included.

Time is of the essence. All the explanations of why it takes so long are nice — but even better would be a focus on how we can speed the communication process up.

6) I owe it to the public health of this country to come forward with my knowledge and put on the record the dysfunction occurring at the federal level. A subsequent review by experts in food borne disease investigations would say this tomato outbreak investigation has bordered on incompetence.

A powerful position by a powerful man. The industry has been sitting, watching and thinking, and feeling this looks disorganized, not thought-out, incompetent. Now we have a world-class expert say it is true: The Emperor Has No Clothes. We need a very careful review of this outbreak by experts in food borne disease investigation to make sure this will not happen again.

7) They needed to conduct full fledged tracebacks all the way back to the source not only of the sick cases but of the control group as well… It was critical for the investigators to learn the locations of where both the cases and controls ate tomatoes and trace back from there.

When doing the trace back, you may come up with a few possibilities of where the tomatoes came from. If you collect data over time of the cases and controls, using the same methods to make the product association, you may find 85 percent of outbreak cases trace back to a certain field or grower, or re-packer versus the control product. Then you begin to get a much better handle on where product came from…

FDA never talked about tracing back product from the control group. It was a near fatal flaw from the get-go, and if they don’t change their approach they will never find the source.

This is it… a flawed investigative approach. When a reporter brought up the issue of tracing the control group, Dr. David Acheson, M.D., FDA’s Associate Commissioner for Foods, found the idea “intriguing” and said the FDA doesn’t do that. Well why not?

We keep thinking the FDA is holding back important information. It is increasingly becoming clear that they are not holding back much; they don’t have much… the whole thing is like the Wizard of OZ. There is nothing behind the curtain.

8) The FDA has done a very poor job of helping the public understand how outbreaks in the produce industry occur. No one can say with certainty when this tomato outbreak ended. But there is overwhelmingly strong evidence this outbreak peaked many weeks ago.

It is a rare opportunity, a “teaching moment,” when the public is paying some real attention to FDA and CDC announcements. So it is an excellent time to speak clearly, honestly and explain the situation.

One can imagine the words: “Because tomatoes rarely grow in the same place for more than six weeks, by the time we learn about these things with our current speed of data collection and analysis, these outbreaks are typically over.” Instead of educating the people, the FDA confuses the people with endless repetition about things being “ongoing.”.

9) These outbreaks end on their own. They were over by the time we figured out what the problem was, if we figured out the problem at all.

This is straight talk. But the FDA and CDC seem unwilling to explain this to consumers.

10) We went to a wise group in the produce industry with no horse in the race. They looked at the patterns and they knew this market so well. This simple task of eliciting help from industry experts was not done by the investigators to any meaningful extent. We do a very poor job of bringing in the industry to solve these outbreaks. What does this mean? That straight-forward questioning didn’t happen in a way that would have been most helpful.

Traceback is fine — but it doesn’t have to start from a point of total ignorance. The first thing in a produce outbreak: You get together with some industry experts. We ran a letter suggesting ready-made panels. We may need to be more ad hoc to avoid conflicts of interest — but let the FDA call us; we’ll get them a panel of five industry experts with no conflict of interest in an hour. We need to kill this “not invented here syndrome” that seems to permeate these investigations.

11) First, the formation of the FDA list is disingenuous. It was based on those that screamed the loudest, and from a public health standpoint that’s not right.

This is what we have been pointing out… the FDA shouldn’t sit passively waiting for people to complain to make up a list of areas “not associated” with the outbreak. It is a recipe for corruption and a perversion of what a public health pronouncement should mean.

12) Another area that must be addressed is the poor job that’s been done in defining the risk. As the Perishable Pundit pointed out so aptly, in a 40-day period, the public consumed three billion servings of tomatoes. We need to provide a better perspective. I don’t see anyone putting this in context.

Yes, a suspicious mind would see an FDA intentionally trying to avoid making things clear — lest they should be seen as ridiculous. What does the FDA believe the risk is if consumers were to eat a tomato from the “forbidden zone” — and how does that compare to the risk of getting hit by lightning, getting in a car accident or a plane accident? If consumers stop eating tomatoes and switch to, say, hamburger, are their odds of food borne illness increased or decreased? If they dump their tomatoes and make an extra trip to the store to get new ones — how does the risk of driving compare to the risk of eating the tomatoes?

Surely the FDA and CDC should put everything in context. What is the risk they are trying to help prevent?

13) The industry also needs to be part of the solution… I’ve seen operators in the food service industry eliminate all tomatoes from the menus questioning the safety of the entire category when areas had been cleared. That is a copout. No tomato or any produce item can ever be 100 percent guaranteed safe. This is a time when retailers and food service operators should be going out of their way to support their suppliers.

Yes, this is an industry problem and requires an industry solution. We have to support the supply side if the supply side is going to be here to provide product.

14) I also wondered why the industry wasn’t pounding away with its own questions. Industry often takes a back seat, in some ways like the Stockholm Syndrome.

Yes, as Alan Siger of Consumers Produce brought up in a letter here, the industry needs a more effective way of calling a spade a spade. The associations are trying but the complexity of their relationships seems to make it very difficult for them to come out and say that an investigation is being conducted in an incompetent manner. Just as the government needs a post-crisis analysis of its actions, so does the industry. We have to be able to stand up and speak out.

15) There should be a call for a formal investigation on what happened and why. I really believe this outbreak is virtually over. The point is not to go back and punish people. The point is to learn so this doesn’t happen again. Outbreak investigations are not just to prevent cases during that time but into the future.

The industry should insist on this — not just a meeting with FDA, but a formal investigation by food safety, public health and epidemiological experts with a published report. We have to get things on the record.

16) Clearly one of the options for the produce industry at this point is irradiation.

Everyone wants a kill step, and we’ve run pieces about irradiation regarding possibilities for spinach, tomatoes and many other items. Once again, though, we think this requires leadership from the public health community. Why can’t FDA and CDC use these opportunities to point out that consumers could be safeguarded through the use of these technologies? We’ve heard no mention that the tomatoes in question can be consumed safely by consumers if they are irradiated — why not? Maybe some farmers would have selected to irradiate crop rather than dump it.

Public health authorities have to speak up and speak honestly about the state labs, about the context of risk, about the nature of produce outbreaks, about the role of irradiation. Instead, we get silence and so things don’t get better.

The industry, the American consumer and all who love truth owe Dr. Osterholm a debt of gratitude. Because he has been willing to speak out, there is the possibility things may get better. That is quite a gift to come from one man.

We intend to hold the nice letter Dr. Osterholm sent us very close for a very long time. We have always respected his intellect and achievements. Now we realize that courage is a character trait as well.

Many thanks to Dr. Osterholm for speaking out bluntly you perform a public service by working so hard to enhance public health.

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