FDA further recommends that retailers, restaurateurs, and food service operators continue to offer cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, from any source.
FDA did NOT simultaneously change its warning to consumers telling them not to eat any raw red plum, red Roma or round red tomatoes but, presumably will get around to doing that soon.
We have to applaud the FDA for working to minimize the extent and impact of its restrictions. For all practical purposes, this really just leaves Mexico as the source of tainted tomatoes, since Florida production is finished.
One wonders if the original FDA warning to consumers in New Mexico and Texas not to eat raw red plum, red Roma or round red tomatoes wasn’t a violation of our WTO obligations. In fact even this revised list might be.
Certainly a country is permitted to safeguard its citizens, but there are plenty of places in the world that can produce these products that we know, for a fact, had no product in the United States since this outbreak began.
If we assume there were no New Zealand tomatoes in the US in the last month or none from Moroccan greenhouses, probably none from Italy and if we further speculate that these countries want to take advantage of a market opportunity to sell red plum, red Roma or round red tomatoes in Texas this week, on what basis does the US government advise consumers not to eat their product? In other words the idea of making a list of areas that are NOT associated with an outbreak is probably not WTO complaint. FDA needs an affirmative reason to believe a country is dangerous to exclude its product.
One day a government will bring a WTO complaint on such a trade restriction.
Still, one of the moral crimes of the spinach crisis was that farms in states never implicated in the problems, and producers of varieties never implicated in the problem, etc., all got crushed.
This move is a sign that FDA is anxious to avoid that kind of collateral damage in its future actions.
That is some very good news.
|James R. Gorny, Ph.D. |
Postharvest Technology Research & Information Center
University of California, Davis
Epidemiology versus Traceback
Twenty months after watershed events in the lettuce and leafy greens industry, the current tomato foodborne illness outbreak scenario is ominously reminiscent of the September 2006 event, with epidemiological data (to determine the most likely food and source of that food) lagging far behind reported/confirmed illnesses cases. The produce supply chain has been again stopped in mid-motion due to a foodborne illness outbreak, and there is deep and pervasive uncertainty in the marketplace. Everyone in the tomato industry is now suffering from being labeled with a broad brush as the potentially responsible party, and it affects those responsible for these illnesses as well as the vast majority of completely innocent parties.
Since September 2006, many persons have advocated for expenditure of more resources to enhance produce traceability, as they believe that enhanced traceability is the most effective means of avoiding the complete shutdown of a produce industry sector. Well, it has happened again and traceability was never the cause of these industrywide shut downs, and it is unlikely that enhanced traceability will ever prevent a future industrywide shutdown.
First and foremost, continued foodborne illness outbreaks being associated with consumption of certain produce items is the real issue here. Continued focus on preventing produce contamination in the first place throughout the supply chain is the most effective means of preventing any and all future produce industrywide supply chain shutdowns.
Secondly, painstakingly slow epidemiological investigations carried out by local, state and federal public health officials are the real cause of these industrywide shutdowns. Epidemiological investigations aim at identifying the most likely root cause of a foodborne illnesses outbreak. This occurs by first identifying clusters of illnesses, making sure the disease-causing agent is exactly the same among ill individuals, determining what common food ill individuals ate and where that food came from. Determining in the epidemiological investigation where the tainted food came from (which store, then which distributor, then which grower/shipper/packer) by identifying commonalities among where ill individuals purchased their food is critical to ultimately identifying the most likely root cause of contamination.
Importantly, epidemiologists investigating the foodborne illness outbreak must be EXTREMELY careful in assuring that the link between what ill persons ate and where they purchased that food item is factually correct. If a false assumption is made early in the investigative process (i.e., wrong food product or wrong point of purchase), it leads the epidemiological investigation down the wrong distribution chain, thus wasting time, resources and ultimately delaying the identification of the true cause of the illnesses.
The real issue regarding industrywide shutdowns is not about produce traceability (although good traceability does help), but it is about epidemiological investigations that are slow, laborious, time-consuming and resource-intensive affairs. Because multiple federal, state and local public health authorities must collaborate in these investigations, it increases the complexity of the task. This is not a criticism of public health officials trying to protect public health but merely a statement of facts regarding these investigations.
Public health agencies are currently fragmented and under-resourced to effectively monitor and respond rapidly to developing public health issues. Why did it take upwards of 6 weeks for public health officials to identify this cluster of illnesses… and then only due to the diligence of state public health officials in New Mexico?
Food industry, government and the public should be concerned about this lagging response time and its subsequent effects on public health and commerce. Since September 2006, each and every foodborne illness outbreak investigation should have been viewed as an opportunity to enhance investigation team response times to assure public health and well being. Simply put, more public health resources are needed to adequately protect public health and commerce in a timely manner or we will continue to see industrywide shutdowns in the produce industry.
We followed up with a quick question: “When New Mexico made its release, it went down to announcing three specific supermarkets that were the issue. Obviously the FDA is looking more broadly in other states, etc., but it seems as if the FDA is rejecting the epidemiology that New Mexico did to trace everything back to three supermarkets.
Is that the way it appears to you?”
And Jim provided a swift reply:
Good question, you’ve hit it right on. FDA is simply taking a much broader perspective. They mostly agree with New Mexico public health officials that ill individuals most likely purchased product from the named New Mexico retail establishments, but FDA is looking at it in a broader context, trying to connect the dots via the epidemiology investigations.
FDA most likely now knows exactly whom the three implicated New Mexico retail establishments purchased tomatoes from, and FDA is now working with regulators in Texas to find the most probable retailer(s) from whom product was purchased by ill individuals. They are looking at lists of each Texas retailer’s suppliers to see if there are any commonalities with the New Mexico retailers’ supplier list.
This points out it is a lot more complex then just traceback. You have to have the traceability, but then you have to be able to do the epidemiology very quickly, sorting through lots of data to find matching common suppliers and making sure you’ve chosen the right retailer to do the traceback.
The slowness in FDA’s response may possibly be that the agency can’t find any commonalities between the New Mexico and Texas suppliers, so they can’t identify the potential responsible party or even a growing region. The FDA is also very careful when making any announcements as they truly do understand the implications. Silence by FDA is currently very painful, but it is better than being falsely accused, as is exemplified by what happened to California Strawberry Growers in 1995.
Jim Gorny has noted something very important with regard to fresh produce. Traceability, important as it may be, is not the primary cause of a delay in identifying the specific source in foodborne illness outbreaks.
When Bruce Peterson launched — along with Michael McCartney — an industry traceability initiative, he identified the problem this way:
As Senior VP Perishables at Wal-Mart, a day didn’t go by… ok, Maybe not every day, but some 250 times a year… where we had a product recall because of a wrong label, wrong code, a date-quality issue, it didn’t taste good, to more serious problems of E. coli, salmonella or lysteria, and most of these recalls were with products you’d know and trust.
Why aren’t these consumer products companies going out of business? There’s a really simple answer: What CPG companies like Proctor & Gamble, Sara Lee, and Kraft have that the produce industry doesn’t have is effective recall.
A CPG company says, “We have a problem with this lot of lunch meat,” then separates it and communicates that to the public in two ways. The company issues a statement, and secondarily FDA issues a statement. All these three things happen within hours, sometimes days, but usually within 24 hours.
Now Jim Gorny is pointing out that as important as effective traceback may be, traceback, by its nature, can’t start until effective epidemiology has identified what the product is and where it was purchased.
Perhaps if Campbell’s Soup gets consumers sick, the sick people tend to have cans of it in the garbage or relatively good recall of the brand, so epidemiology gets to the proper source quickly. If it was a tomato, few will remember the brand. The tomato might have been on a sandwich from a restaurant or bulk product from a supermarket. Consumers may not be able to state clearly what variety of tomato they purchased.
The important question that Jim asks for the whole industry is this: Why did it take upwards of 6 weeks for public health officials to identify this cluster of illnesses… and then only due to the diligence of state public health officials in New Mexico?
Jim is undoubtedly correct. If it is going to be weeks and months to identify what product is responsible for an outbreak, we will have two big problems: first, people will unnecessarily get sick. Swift epidemiology can save lives and prevent illness. Second, if we have partial indications of things for weeks and months, the FDA will feel a need to act on limited information and will thus impose excessively broad restrictions on sales.
Of course, the great advantage for the industry of focusing on traceability is it is the part of the puzzle we can actually do something about.
We can all agree with Jim that, as he wrote: “First and foremost, continued foodborne illness outbreaks being associated with consumption of certain produce items is the real issue here. Continued focus on preventing produce contamination in the first place throughout the supply chain is the most effective means of preventing any and all future produce industrywide supply chain shutdowns.”
Yet we must recognize that we don’t have a failsafe way to achieve this yet. That is why we are investing, as an industry, in things such as The Center for Produce Safety. We certainly hope to one day rid ourselves and the world of the scourge of foodborne illness but, in the meantime, we have to manage the problem.
In addition, as Jim states, we may all be able to acknowledge that “Public health agencies are currently fragmented and under-resourced to effectively monitor and respond rapidly to developing public health issues.”
Certainly the industry can lobby to get more resources for agencies that hold our future in their hands. But whereas we can decide to implement industry traceability and make it happen, we can only hope to influence public policy discussion on the relative merit of funding different aspects of the public health authorities.
Yet Jim Gorny’s letter is of utmost importance because we have to understand the problem to begin solving it. Jim is right… this is a teachable moment. What we learn just by looking at the tomato/salmonella situation is that we need more effective, more rapidly deployed, more insightful epidemiology.
This is not an easy problem to solve. Effective epidemiology requires a rare combination of art and science, half Sherlock Holmes and half Louis Pasteur. Many of the best leave government service for more lucrative opportunities in the private sector. State departments of health are wildly irregular in their competency and even within FDA, the competency levels vary wildly.
Can the Center for Produce Safety look to develop better tools for epidemiology in produce? Can the government relations pros at PMA, United, WGA, FFVA, etc., get budget allocations to beef up staffing and pay people in a way likely to increase competency?
Many growers are already suffering as a result of the consumer warning not to eat certain types of tomatoes. If we use this moment as a turning point to focus industry efforts on this critical area of epidemiology, perhaps some of this hardship will not be incurred in vain.
Producers of tomatoes not implicated in the salmonella outbreak are hoping consumers will still be open to consuming tomatoes and that retailers will make plenty of shelf space available to these “permitted” varieties.
Here is press release one vendor based in Texas sent out:
50% OF TOMATOES DEEMED SAFE FOR RAW CONSUMPTION
Cherry, Grape and Tomatoes-on-the-Vine Varieties
not Subject to Salmonella Alert
San Antonio, TX — Desert Glory, which markets the NatureSweet brand, and is North America’s largest grower of greenhouse tomatoes, is calling attention to the fact that more than half of all tomatoes bought in grocery stores in the US are not subject to the June 1, 2008 Salmonella alert issued by the US Food and Drug Administration (FDA). According to the alert, FDA advised consumers in New Mexico and Texas to “limit their tomato consumption to tomatoes that have not been implicated in the outbreak.” The FDA noticed specifically stated that cherry tomatoes, grape tomatoes and tomatoes sold with the vine still attached have not been implicated in the outbreak.
In a letter addressed to its customers, Bryant Ambelang, Desert Glory Chief Marketing Officer, reinforces the safety aspects of its greenhouse operations. “All of our NatureSweet branded tomatoes are grown in a highly controlled greenhouse environment, which allows us to regulate all aspects of tomato production and processing.”
Ambelang has indicated it is important that consumers understand there is significant availability of cherry, grape and on-the-vine tomatoes, which account for more than 50 percent of all tomatoes bought in U.S. grocery stores. Desert Glory says that food safety takes a top priority, which is why the company invests in greenhouse operations, private wells, continual testing procedures and 100% product traceability.
The FDA warning is tough enough… Texas is a big state, so the loss of sales in Texas and New Mexico certainly will matter.
The two wild cards in this issue are these: 1) Will consumers outside of the Texas/New Mexico zone veer away from tomatoes, not wanting to take any risk? 2) Will those in the zone switch to tomato varieties that are available, or will they steer clear of all tomatoes?
The answer will depend on the media and how stores merchandise and market. If retailers shrink shelf space and abandon tomato promotions, the ride will be rocky indeed for major suppliers.
Now that the FDA has changed policies and is allowing sale of all types of tomatoes from many producing regions the question changes: will consumers in Texas, New Mexico and/or elsewhere shy away from tomatoes because of all the bad publicity?
Much will still depend on how retailers market and merchandise in the aftermath of this situation.
We included an Alert issued by the New Mexico Department of Health in our piece, Salmonella and Tomatoes Linked in New Mexico, and now we asked Pundit Investigator and Special Projects Editor Mira Slott to see what else we could learn from New Mexico.
New Mexico Department of Health
Santa Fe, New Mexico
A: As of June 5, 48 patients have been confirmed sick with salmonella Saintpaul. Of those, 36 contain the same fingerprint match to the strain of the outbreak. The other 12 are still being tested. The outbreak now covers 11 counties.
Q: What is the most recent date that someone reported their illness started? Are these increasing numbers of people infected (June 4 release, May 31 release) based on new patients that are just reporting becoming ill in the last few days?
A: The latest onset of illness is May 27. These are people, whose lab results were confirmed to be matches with the outbreak strain. There is always a lag time between self-reporting and conclusive results. I don’t know how many cases are pending.
Q: The New Mexico Department of Health’s latest release dated June 4, states, “Many grocery stores in New Mexico have been stocking tomatoes that originate in Mexico. The Department of Health and federal agencies are still investigating the source of the outbreak.” Do you have any more information to substantiate this inference that the tomatoes in the outbreak come from Mexico?
A: The stores in New Mexico implicated in the outbreak are telling us that at this time of year tomatoes they have been stocking are coming from Mexico. We are not making any definitive conclusions. The source is still under investigation.
Q: In your May 31 release, the New Mexico Department of Health recommends that individuals and restaurants that bought tomatoes from Wal-Mart in Las Cruces or Farmington, Lowe’s in Las Cruces, or Bashas’ in Crownpoint since May 3 should not eat them uncooked. Since this time, have any more retailers or chain locations been added?
A: No. The stores linked to the outbreak are still limited to those listed. That could change. We’re still in the process of interviewing patients. Some patients were hospitalized, making it more difficult to gather information. We’re advising people to follow federal recommendations because we haven’t ruled out that other stores may be involved. And FDA is giving the public information on how to protect themselves, and we want the public to get consistent information.
Q: Your Health Secretary Dr. Alfredo Vigil is quoted saying, “It is important to emphasize that no locally grown tomatoes from New Mexico have been implicated in this outbreak.” FDA and CDC are advising all consumers in New Mexico and Texas to limit their tomato consumption to tomatoes that have not been implicated in the outbreak. By including that statement in your release, are you suggesting to consumers that it is OK to eat locally grown tomatoes, even if they are raw Roma, plum or red round tomatoes?
A: There are many farmers in New Mexico growing conventional and organic tomatoes to sell or keep for their own supply. They have not been implicated. But everything is couched under the premise that this is an ongoing investigation. No information we have would lead us to believe locally grown tomatoes in New Mexico are a problem.
Deborah Busemeyer has won some notice as a vaccine advocate, and she is an effective advocate for her department. She is too politic to say it but it is clear that there is some tension between New Mexico’s position and that of the FDA.
New Mexico was way ahead of the FDA on this and has basically done enough epidemiology to come to the conclusion that it was three particular supermarkets in New Mexico that were ground zero.
Once the New Mexico Health Department made that determination, the trade’s traceback ability kicked in and the trade, worked with the New Mexico Health Deparrtment, and both were quickly able to determine that the tomatoes came from Mexico.
On the other hand, the New Mexico Health Department doesn’t want to buck the FDA, so the New Mexico Health Department keeps issuing these conclusions — but hedging with the caveat that the investigation is still ongoing.
The epidemiology leading to these three individual supermarkets strikes us as odd though. All these chains distribute through distribution centers. So if a single Wal-Mart store, for example, had this problem, and it is related to product, one would expect to see it in other Wal-Mart stores supplied by the same distribution center.
Now, of course, it could be a rare, sporadic episode that only affected a tiny portion of a shipment that happened to go to that one Wal-Mart store — but then how would you expect to see it in three chains?
The only logical way we could imagine these three stores, and only these three stores, being implicated would have been if some independent vendor was selling door-to-door and the managers of these three stores purchased direct, going outside their distribution systems to get a great deal.
This would not only tie all three stores but would mean the produce had not been vetted through the chains’ food safety or quality assurance departments.
Presumably New Mexico and the FDA are looking at all possibilities.
Just as we were writing this piece, another department, the New Mexico Environment Department, sent out a news release. We’re not sure how the people of New Mexico get helped by having multiple departments work on this one outbreak but, apparently, in New Mexico the Environmental Department regulates supermarkets and restaurants.
Many thanks to Deborah Busemeyer and the New Mexico Department of Health for helping to keep the industry informed.
One of the big questions we don’t know the answer to is whether any warning on consumption of tomatoes is justified at all. We know that sometimes by the time the government acts, the crisis has long passed. When the FDA imposed its “import alert” on Agropecuaria Montelibano, a Honduran grower and packer, it was March 22, 2008, and the last person known to have gotten sick was on March 5, 2008. Since Salmonella has an incubation period of 12 to 72 hours after infection, we know that by the time the FDA issued its Import Alert, the outbreak was over.
We don’t have enough information to say definitively what the situation is with the Salmonella Saintpaul outbreak and tomatoes. The CDC info sheet says that “Among the 38 persons who have been interviewed, illnesses began between April 23 and May 27, 2008.”
Now information can come in irregularly on this type of thing, and until all the information is in we won’t know the final result. Still, what can be useful is knowing the trend. Of the 38 people who have been interviewed, if we started off with one person sick on April 23, two sick on April 24, three sick on April 25 and then hit a peak on, say, May 4, with a decline every day thereafter to a May 27, when one person fell ill, this would give us some notion that we are near the end of a bell curve.
On the other hand, if the numbers had been increasing since April 23, and May 27 was the peak day, this is a strong indication that we still have a ways to go on this outbreak.
We asked Mira Slott, Pundit Investigator and Special Projects Editor, to find out more:
Centers for Disease Control and Prevention (CDC),
Q: Could you clarify the time line from the date when the first person reported getting ill to the most recent date a person reported getting ill? In that time line, could you provide us with data on how many people reported being ill by dates and location?
A: We are in the middle of the investigation. It is too early to establish a time line. There is a range when people reported that they got sick. You’ll see in CDC’s release of June 4, words are chosen judicially and specifically. Among 38 persons interviewed, their illnesses began between April 23 and May 27, 2008. This was a case study.
The epidemiology was conducted by New Mexico and Texas and Indian Health Service. There are 29 additional persons with the outbreak strain of salmonella Saintpaul in other states. Investigations are going on in those states to determine if those illnesses are linked to tomatoes. States are still monitoring and working through Pulsenet. This is the latest data CDC has collected.
Q: How does the scientific and epidemiological process work?
A: There is self reporting by people of when they got sick. Part of the epidemiological work is case/controlled studies of those who became ill. The case study by New Mexico, Texas and Indian Health Service identified the link to tomatoes. That same kind of work is now being done in those other states. The state health department asks a series of questions to determine what made them sick, in addition to the lab work of the genetic fingerprint, when did they get sick, what products purchased, where, etc.
The phrasing in CDC’s release of “when illnesses began” is when the person reported they got ill. That’s a wide range as well. Look at Salmonella; it develops between 12 to 72 hours after the infection, usually lasts four to seven days, and most of these people may not even report it. These people who report actually got sick enough to go to the doctor, and the private physician or hospital does a stool sample and waits to get the lab results back. CDC is taking great care to report what they report.
In the case of the spinach E. coli outbreak, the system worked perfectly and information came together in two weeks. With this one, you don’t even have two weeks from May 27.
Q: I still don’t understand why CDC couldn’t provide the data or a chart showing what you know at this point. Why not provide the number of people reporting illnesses each day or each week by region or state, based on what you’ve determined as the onset April 23 to the most recent on May 27? You can always update the information as you learn more.
A: It is difficult to develop analysis without knowing the methodology used; you have to know the scientific methods and the epidemiological work involved. You can’t start manipulating our data. We’re still at an early stage.
The numbers reported may change at the end of the day after we talk to the states. They may come up. It takes additional time, depending on the Pulsenet systems in each state; data may not have reached the U.S. Health Department yet from the individual states. This is quick, real time information. There may be people sick during that time frame whose lab results haven’t presented themselves.
Q: The longer it takes to hone in on the problem, the greater the damage to consumers and the industry. It seems the more information you could provide, the faster people might be able to narrow down the problem and pinpoint the source.
A: This is an ongoing investigation, with epidemiology studies continuing in states and here. We are actively involved in lab work, and haven’t gotten to a documentation of how many people got sick in different time periods. With outbreaks, it’s hard to say a bell curve until it’s over. Tomatoes do have a certain shelf life, and also FDA is doing a traceback investigation.
What concerns us here is that CDC is not acting in a spirit of openness and transparency most likely to produce optimal results. We are all adults; we know this dataset will change every day as new people are interviewed.
But there is something wrong with CDC trying to maintain a monopoly on information in a situation such as this. Why not tell what we know now, with the understanding that we are learning more every day? In this case, it would be very easy for CDC to post a graph with the onset date of the reported illnesses.
This is an area where the industry’s government relations staffs might want to look at legislation to compel the release of this kind of information in a timely fashion.
We have nothing but respect for the CDC and know it has many intelligent and hard-working people trying to do the right thing.
That is more likely to happen if its decisions and those of the FDA are subject to contemporaneous scrutiny by the best minds in the private sector. This means that the bias should be toward sharing information, not attempting to control it.
As it is right now, the FDA imposed its warning for Texans and New Mexicans not to eat certain types of tomatoes on June 3. The last person known to have become sick did so on May 27. With a 12 to 72 hour incubation time, this means the outbreak may well have been over by the time FDA got around to issuing its alert.
It is one thing to harm an industry to enhance the public health; it is another thing entirely to severely damage an industry so that FDA can look like it is doing something to enhance public health.
Taxpayers deserve to know which it is and the CDC should tell them voluntarily.
We thank Ms. Russell for the time she spent helping the industry become better informed.
We were pleased to feature an informative interview with Trevor Suslow, Ph.D., Extension Research Specialist, Postharvest Quality and Safety, Department of Plant Sciences, University of California, Davis, as part of our piece Salmonella And Tomatoes Linked In New Mexico. The interview included some discussion of the incidence of Salmonella Saintpaul.
We are fortunate to have one of the world’s preeminent experts weigh in on the matter:
In 2005, Saintpaul was #9 in humans.
Between 1995 and 2005, it varied between 436 and 838 isolates per year reported in the US. (See table 3, Page 16 at the link below)
You can download surveillance reports here
|Robert Tauxe, M.D., M.P.H.|
Division of Foodborne, Bacterial and Mycotic Diseases,
National Center for Zoonotic, Vectorborne, and Enteric Diseases, Centers for Disease Control and Prevention
Many thanks to both Dr. Suslow and Dr. Tauxe for their efforts to keep the industry informed.