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FDA Finds One Jalapeno
With Salmonella Saintpaul
And Asserts Authority To Bankrupt
Innocent Parties As Part Of FDA’s
Pursuit Of Vague "Public Health" Goals

The FDA continues its habit of making mountains out of mole hills. The discovery of a single jalapeno with Salmonella Saintpaul at the warehouse of a tiny distributor named Agricola Zaragoza on the McAllen Produce Terminal Market simply doesn’t mean very much.

Oh sure, FDA got a recall out of this little firm that doubtless confronted FDA without its own epidemiologist. That just means FDA is very intimidating since they have so much discretion that they can close down a business with border holds and selective sampling. It doesn’t mean this one single pepper has anything to do with the outbreak.

Here is a scenario: A buyer on the McAllen market goes to lunch on Monday and gets an upset stomach but comes to work on Tuesday. His bathroom sanitation is not perfect. He opens a box of jalapenos to check them out, runs his fingers through them, puts the box back.

Thus we come to a single pepper with Salmonella Saintpaul on it that came to be discovered by the CDC. Not the cause of an outbreak, but a victim.

Or another scenario: Salmonella Saintpaul is rare, but not unknown. Last year, there were actually six people known to be infected with Salmonella Saintpaul between April and June of 2007. Utilizing the CDC multiplier of over 30 unknown cases for every known case, we would say that there were around 200 cases of Salmonella Saintpaul in that three-month period last year.

Yet just ask anyone on Wall Street who was recently burned on investments by events that, statistically, would only occur once every hundred years and you learn that statistics are tricky things. The fact that something statistically will only occur once each century does not mean it can’t happen three times this week.

So this singular pepper may simply be a coincidence, having nothing to do with the outbreak.

Of course, the discovery could come to mean something. Although this little distributor is implausible as the vector for an outbreak of this scope, if the traceback to the farm leads to something, then this finding would be significant.

The fact of the matter, though, is that it hasn’t. This lone finding means, literally, nothing.

Because the FDA likes to celebrate its accomplishments, it held a press conference and portrayed this inconsequential, this meaningless finding, as significant. So we wind up with highly predictable headline, such as the U.S.News & World Report Healthday column proclaiming that Peppers Picked as Salmonella Culprit. In fairness, this is not what CDC or FDA said — but they knew what headline they would get.

Dr. David AchesonOnce again, needlessly and with reckless disregard for the rights of innocent people, the FDA has destroyed an industry. Louise Schiavone of CNN, whose dogged determination has come to be a priceless resource for the country in this matter, asked FDA’s Dr. David Acheson, M.D., Associate Commissioner for Foods, point blank: What about farmers in, say, the northeast, who never ship their product through Texas… will they be exempt from your plan to ban jalapenos?

Yet, Dr. Acheson thinks that it is within his authority to destroy the fortunes of innocents.

He falls back on two things: First, FDA’s imperfect knowledge. He speculates before the national media that perhaps the peppers from Agricola Zaragoza were sent to the northeast and met in a distribution center with northeast-grown jalapenos. Yet, these are implausible scenarios, and an agency charged with regulating food safety on this industry should either know better or ask for help from USDA and industry. Second, like Harry Potter hiding behind his invisibility cloak, Dr. Acheson hides behind the mantle of public health.

Repeating the words “public health” as a mantra, though, does not make it true. The bottom line is that the risk for healthy people of eating fresh jalapenos was always inconsequential and, at this date, is de minimis. FDA’s issuing of a ”Recommendation Not To Consume” and asking foodservice and retail operations not to serve these items is a very different thing from the FDA issuing a notice about what the FDA believes the risk is of consuming these items.

Despite the intense attention to this outbreak, despite the CDC drafting extra labs to speed up processing of illnesses, no new case of sickness has been reported since July 4, 2008!! That is 17 days ago. Salmonella reveals itself within 72 hours.

The FDA just decided to destroy the chili pepper industry — yes, jalapenos are a tiny item but they account for more than half the shipment, typically, of the little guys who sell chili peppers. Without the jalapenos, they won’t fill up the trucks and the whole chili pepper business will die — after the outbreak was over.

Beyond this, the singular thing that has to come out of this outbreak is that the FDA must fulfill its obligation to public health by declaring what it knows but must be prohibited by law from making recommendations.

These recommendations are de facto recalls — the liability of selling product the FDA is recommending against makes an FDA "recommendation" function as a constructive recall. Yet these recommendations are based on nothing other than Dr. Acheson’s personal metric of risk aversion.

People elect to take risks. They sky dive, hang glide, deep sea dive, ski, mountain climb… they drive cars, take airplanes. Some even order a rare hamburger, or eat steak tartar or a raw milk cheese. There is a whole movement of people who demand the right to drink non-pasteurized milk.

A quick look at the epi curve, and one sees the daily incidence has been declining for over a month. What could Dr. Acheson possibly think the risk really is?

The answer is Dr. Acheson doesn’t know and doesn’t care. In the press conference, he was asked what the cost would be of discarded pepper and he said he didn’t know. We would point out that he doesn’t know because he doesn’t want to know.

Dr. Acheson honestly believes that if thousands of people go bankrupt because he made a proclamation, then that is OK — mere collateral damage on the road to protect public health.

In America, though, it is not OK and the FDA must be restricted from destroying the property of innocents. We discussed the ethics of this here.

People have interests in safe food, but they also have an interest in the pursuit of happiness. If the FDA thinks it can just shut down a New Jersey jalapeno farm on the odd chance that maybe it has something to do with something, then we are no longer a government of laws, we are just at the mercy of men like Dr. Acheson.

If this kind of behavior is acceptable by government, it is not likely that the jalapeno growers will be the final victims.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Senator Harkin Calls For Reform
Of FDA’s Food Safety System

Late in the evening on July 15, 2008, we received a nice note from Adela Ramos:

I work for Senator Tom Harkin on the Senate Agriculture Committee and I wanted to make you aware of a letter we sent today on the Salmonella outbreak.

I’ve been reading the Perishable Pundit for some time now, and it’s a great source of information — some of which was used in this letter.

Adela is Senator Harkin’s point person on ag issues, and we are honored to have her readership as well as that of so many other staffers, from both sides of the aisle, in Congress.

The problem at FDA is partly a kind of arrogance. There is not even the pretense made of trying to work together with industry to solve problems, nor any notion that laws might restrain the conduct of FDA executives, so the participation of members of Congress in any attempt to reform the food safety system is vital.

Congress can get answers that the industry simply cannot, and the knowledge that important Congressional leaders such as Senator Harkin are concerned and will be pursuing these matters makes a cover up at FDA less likely. Look at what Senator Harkin had to say:


How Can the Government Tell Consumers
We Don’t Know The Source of What
Made Over 1000 People Sick?

Washington, D.C. — Senator Tom Harkin (D-IA), the Chairman of Senate Committee on Agriculture, Nutrition and Forestry, today called on the Food and Drug Administration (FDA) to initiate an effective trace-back system to allow tracing of the origins of fresh produce in food safety outbreaks. Harkin did so as the Centers for Disease Control and Prevention (CDC) announced this week that since April, 1148 persons have been infected with Salmonella Saintpaul, with cases that have been identified in 42 states, the District of Columbia, and Canada.

In a letter to Health and Human Services Secretary Leavitt, Harkin said that the Salmonella outbreak demonstrates the need for better coordination and communication among federal agencies, industry, and the states, as well as a strong trace-back system to determine the source of food-borne illness outbreaks.

“Each food-borne outbreak seems to be larger than the next, and in this case, over a month has lapsed and the origins of this case are still unknown,” said Harkin. “The victims of this outbreak are growing by the day and don’t know what food made them sick because the source of contamination remains a mystery to the Food and Drug Administration. How do you tell over 1,000 people we don’t know what made them sick?

“In the face of stark warnings about the vulnerability of our food supply, it is time for the government to take action and implement effective trace-back processes so that we can quickly track the origins of contaminated food products in order to prevent increasing cases of illness. It is long past time for the government to take comprehensive steps to increase our response to food-borne illness outbreaks.”

The full text of the letter follows.

July 15, 2008

The Honorable Michael O. Leavitt
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Dear Secretary Leavitt:

For over a month now, since June 3, 2008, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been communicating to the public and with the fresh produce industry about an extensive outbreak of Salmonella while conducting a trace-back investigation to determine the source of the outbreak. The growing outbreak — with 1,148 persons infected with Salmonella Saintpaul to date and with a growing list of suspected fresh produce items — points to the need for better coordination and communication among federal agencies and departments, and with states and industry. Most importantly, the outbreak once again underscores the need for a tracking and trace-back system that is modern, effective, and protects public health. This outbreak has shown that the systems in place at FDA and CDC to track down the source of a contamination event, regardless of whether the contamination is intentional or not, are woefully inadequate. The Salmonella outbreak also shows that substantive changes are needed in how FDA and CDC communicate with the public and with industry.

I don’t doubt the difficulty of the task or the dedication and hard work of FDA and CDC personnel. There are, however, many questions that need to be answered about this particular investigation, particularly if the source of the contamination is determined to be a product other than tomatoes, the primary suspect in this particular Salmonella outbreak. Both the tomato industry and at least one prominent food safety expert have questioned the slow, cumbersome, and potentially erroneous manner in which FDA has been conducting its trace-back investigation. For example, FDA and CDC have not emphasized comparing the origin of food products consumed by individuals who became ill with Salmonella Saintpaul and the origin of the same type of food products consumed by individuals who have not become ill from Salmonella. This practice of conducting a trace-back investigation of food products consumed by patients who are not sick seems to be one tool commonly used to identify the source of contamination. Why haven’t FDA and CDC employed this strategy during their own outbreak investigation? It seems that the scope of the search could have been narrowed down early by better investigation techniques and had a functional trace-back system been in place.

The inability of FDA and CDC to trace food products from farm to fork has been called into question by the Salmonella outbreak. There should have been a better system in place before this outbreak. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires facilities that manufacture, process, pack, transport, distribute, receive, hold, or import food, except for farms and restaurants, to keep records on the immediate previous source and the immediate subsequent recipients of the food to establish a better trace-back process. The implementation of this Act’s trace-back requirement, as well as the trace-back techniques used in outbreak investigations, needs to be re-evaluated and improved upon in order for the agencies to conduct efficient and adequate trace-back investigations in the future. It is essential FDA move quickly to establish a strong trace-back system using its authority under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and its other authorities. I believe there is adequate existing FDA authority to implement an effective trace-back system. If FDA lacks authority in any respect to achieve this critical objective, Congress must be advised immediately on what is needed.

The events surrounding the Salmonella outbreak demonstrates a startling unfamiliarity with an industry whose safe food production FDA is supposed to oversee. The tomato industry as well as the U.S. Department of Agriculture (USDA) have extensive knowledge and information on harvests, distribution patterns, and retailers that FDA and CDC can tap into in order to speed up trace-back investigations. USDA, the federal department that has the most contact with our nation’s agriculture producers, has been woefully underutilized throughout the entire outbreak process. It has been disturbing to witness FDA and CDC choose not to access this readily-available information from USDA or the tomato industry. This was most apparent by FDA’s compilation of a list of states and foreign countries that were not implicated in producing tomatoes suspected to be the source of the Salmonella outbreak.

If a good share of the tomato supply had been eliminated as a source early on, that would have helped to refocus the search and would have likely sped up solving the mystery, it would have allowed consumers to consume tomatoes and not worry, and would have avoided the enormous losses experienced by tomato growers and distributors. It would seem that FDA and CDC could have easily compiled a list of states and countries where tomatoes were not being harvested at the time of the outbreak. Instead, it was up to all 50 states as well as foreign countries to contact FDA and make a case why they should be on the list of cleared states and foreign countries. Consequently, the process used by FDA to determine which states were not the source of contaminated tomatoes seemed to be a subjective determination based on the ability of the state or country to contact FDA and make the case why that state or foreign country should be declared as a safe tomato-producing region for purposes of the Salmonella outbreak. The manner in which this list was compiled is contrary to a logical investigation where decisions are based on objective information, and where FDA automatically could have ruled out all states that were not harvesting tomatoes during the outbreak.

Another point that highlights the need for better communications from FDA and CDC is the continued warnings against tomato consumption. It seems highly unlikely that tomatoes harvested in April would still be consumed fresh by consumers in late June. It does not make sense why there remains a strong warning against eating certain fresh tomatoes when most states have been cleared by FDA as having produced tomatoes not implicated in the Salmonella outbreak. The warning could be stated in a clearer fashion to assure customers that most tomatoes are safe to eat and are not part of the Salmonella outbreak. FDA and CDC have also failed to clearly inform consumers and retailers that only a fraction of fresh tomatoes were suspect and that many varieties were safe to eat as were all tomatoes from some states. Large restaurant chains, such as McDonald’s, discontinued all tomato purchases needlessly, since there were and still are plenty of tomatoes cleared of any implication of Salmonella contamination. The agencies should have provided clearer information to tomato retailers since some retailers’ complete ban on tomatoes added immensely to consumer misinformation. FDA and CDC should have also provided stronger, publicly-available guidelines to tomato retailers about which tomatoes to sell in order for consumers to know that retailers were not serving tomatoes not approved by the FDA.

FDA and CDC need to take measures immediately to improve their ability to trace-back products and to improve communications with the public and industry. The federal government has been cautioned numerous times in recent years about the potential threats that exist for intentional and non-intentional contamination of the food supply. If we do not have adequate trace-back and communications, the damage to public health and to industry in a future outbreak event can be much more devastating than the current Salmonella outbreak. It is clear that stronger prevention measures of food-borne illness outbreaks are needed, but this particular outbreak shows that our response system is in sore need of improvements as well.

I appreciate your attention to these pressing questions and I look forward to your response.


Tom Harkin

cc: Dr. Andrew von Eschenbach, Commissioner, Food and Drug Administration
Dr. Julie Gerberding, Director, Centers for Disease Control and Prevention
The Honorable Ed Schafer, Secretary, U.S. Department of Agriculture

Senator Harkin deserves every commendation for sending this letter. Iowa is not a major tomato growing state. Sure there are wholesalers, repackers and retailers in Iowa that deal with tomatoes, but still, all Senators are very busy people and the Gentleman from Iowa could have easily elected to sit this one out. That he did not shows a true measure of leadership for which a grateful nation owes its thanks.

Senator Harkin’s letter raises five primary concerns:

  1. The incompetence of the investigation leading to greater public health risk and greater harm to industry. The piece alludes to the interview we published with Michael T. Osterholm, PhD., MPH in which, in another act of leadership, this leading authority on public health spoke up and challenged the actions of CDC and FDA. Specifically Dr. Osterholm attacked the failure to do tracebacks on the control groups.

  2. The whining of FDA about inadequate traceback capability by industry and inadequate FDA authority. Senator Harkin points out that the Bioterrorism Preparedness and Response Act of 2002 already legally requires traceback and traceforward. In other words, which company, precisely, has FDA found that needs to be charged with failure to follow existing law? If no company has been found breaking the law, then what precisely is the traceback problem? Senator Harkin is also very blunt about the FDA’s constant yammering that it needs more authority: “I believe there is adequate existing FDA authority to implement an effective trace-back system.” Of course, Senator Harkin is willing to listen but he is, after all, rather knowledgeable in these areas.

  3. The shocking ignorance of FDA about areas within its jurisdiction and the failure of FDA to access USDA and the industry to help solve the problem. Senator Harkin explains it this way: “The events surrounding the Salmonella outbreak demonstrates a startling unfamiliarity with an industry whose safe food production FDA is supposed to oversee. The tomato industry as well as the U.S. Department of Agriculture (USDA) have extensive knowledge and information on harvests, distribution patterns, and retailers that FDA and CDC can tap into in order to speed up trace-back investigations.”

  4. The odd manner in which a public health agency elected to put together its list of places “not associated” with the outbreak. Senator Harkin explains: “…the process used by FDA to determine which states were not the source of contaminated tomatoes seemed to be a subjective determination based on the ability of the state or country to contact FDA and make the case why that state or foreign country should be declared as a safe tomato producing region for purposes of the Salmonella outbreak. The manner in which this list was compiled is contrary to a logical investigation where decisions are based on objective information…”

  5. Inept public communication. Senator Harkin elaborates in this manner: “It seems highly unlikely that tomatoes harvested in April would still be consumed fresh by consumers in late June. It does not make sense why there remains a strong warning against eating certain fresh tomatoes when most states have been cleared by FDA as having produced tomatoes not implicated in the Salmonella outbreak….”

The points are correct; the only emphasis we might shift is we want to make clear that in communicating to the public about risk, CDC and FDA have an obligation to provide both a numerator and a denominator. To simply say something has “risk” is meaningless in a world where we all gladly drive in cars and fly in planes.

Rather than the FDA feeling itself obligated to make recommendations — which are only driven by the subjective risk tolerance of FDA executives — the FDA should view its role more in an educational sense. What is the risk? What is the risk of eating something else? What is the risk of going to the store to replace your food stocks? Honest discussion of risk, rather than scaremongering over infinitesimal risk, should be the order of the day.

Senator Harkin is much to be thanked. Unfortunately, the influence that the industry might have in DC is pretty heavily invested on the ag side of things and pretty weak on the committees that supervise Health and Human Services. So we depend on people such as Senator Harkin to stand up for us.

Perhaps our favorite line in the whole letter is at the end when Senator Harkin says, “I look forward to your response.”

When Bryan Silbermann of PMA and Tom Stenzel of United Fresh sent their own letter requesting a meeting with Secretary Leavitt, he was in no hurry to respond, so they sent him a second letter.

Of course, Senator Harkin may get a faster response. After all, he has one thing neither Bryan Silbermann nor Tom Stenzel have — a vote on the FDA appropriation.

Many thanks to Adela Ramos for passing this on and a deep appreciation to Senator Harkin for standing up when you didn’t have to.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Important Questions Never Asked,
According To Navajo Nation Investigators

Investigators from the Navajo Nation’s Bio-Terrorism Preparedness Program (BTPP) in New Mexico are going back into the field to re-interview both “cases” (people who fell ill) and “controls” (people of similar demographics who remained healthy) as part of the national effort to get to the bottom of the Salmonella Saintpaul outbreak.

So explains the Gallup, New Mexico Independent in a piece entitled, Say it Ain’t Salsa: Ingredients Newest Suspect in National Salmonella Outbreak. A hat tip to Pundit Investigator and Special Projects Editor Mira Slott who brought to our attention two particularly interesting paragraphs:

The tribe’s BTPP said that when affected individuals were interviewed in May, they were not asked if they consumed peppers or cilantro — both of which have now been identified as suspect to salmonella contamination. The local cases were also not asked many questions about restaurant eating.

The investigation team is also expected to focus on the people who prepared the food eaten by those who became ill with Salmonella Saintpaul.

This is rather shocking.

First — One wonders what kind of inquiry the CDC makes on these surveys before lending them credence?

Second — The whole case against tomatoes was built on the notion that there was a statistically significant correlation between the case and control on consumption of tomatoes but not on other items. Yet if nobody even asked about these other items, how meaningful can this difference be?

Third — New Mexico came right out and listed the names of three retailers that were implicated. If, however, they didn’t even ask much about restaurants, how credible was the implication of these retailers?

We’ve suggested in a piece entitled, Lukewarm Indictment of Jalapenos: Solving Outbreak Requires Thinking Outside the Box, that we need to be looking at vectors that won’t show up in a food survey as this could explain the ambiguous food survey findings. We suggested, specifically, looking at cross contamination from chicken and, in an outbreak this large, human transmission via food preparation.

Yet this is the very first time we have heard of anyone involved with the investigation mentioning a non-food transmission agent — specifically people preparing the food — as a possibility.

Who knows… maybe they read the Pundit down in the Navajo Nation?

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Madness Must Stop

It was simultaneously a moment of poignancy and good sense when during United’s conference call held to update its members and solicit input and ideas regarding the Salmonella Saintpaul outbreak, Drew McDonald, Vice President of Quality Systems at Taylor Farms, basically asked this question: How is it possible that we have gotten to the point that top FDA and CDC officials are holding national press conferences in front of the most important media and speculating almost randomly about highly unlikely events — such as the outbreak being caused by one farm that had been growing tomatoes during the early part of the outbreak and then switched over to jalapenos in the latter stages of the outbreak?

Drew pointed out that there were actually people directly involved and knowledgeable about the pepper industry. Why didn’t the FDA gather together a group of these experts and get these questions answered up front so that the FDA and CDC people could avoid this harmful and distracting speculation when real knowledge is available?

Of course, Drew was 100% correct, and it is in many ways unfair to ask Tom Stenzel, President and CEO of United Fresh, or any association executive to explain or justify such behavior.

Supposedly things are getting a little better, but one really wants to say of these high-IQ people at CDC and FDA that they just spent one year too long in graduate school and have simply lost touch with the real world, the limits of their knowledge, the effects of their actions on others.

Drew is a smart guy, very knowledgeable on food safety and well connected. If asked, he would have helped solve this problem — but the CDC and FDA suffer from a “not invented here” complex.

Trying to use only its own resources is slowing down these investigations and thus injuring public health along with decimating industries. This madness simply must stop. And we have to work on Congress to make it stop. We can’t hope that FDA and CDC will reform themselves from within.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

FDA Town Hall Meeting To Be Held
During United Public Policy Conference

United came out with an announcement that it will hold an FDA Town Hall Meeting at FDA headquarters during its September Washington Public Policy Conference:

The Town Hall meeting will allow industry members to talk with top FDA officials to ask questions and hear their views on all key questions regarding produce safety, outbreak investigations, and regulatory issues. We’ll also discuss ways in which the industry and government can work together better to assure consumer confidence in the abundant array of safe and healthy fresh fruits and vegetables we bring to consumers.

That is a great thing, and although we don’t see any specific attendee commitments announced we presume many of the bigwigs will be there.

Although it will be a big draw, the event takes place simultaneously with United’s Congressional visits at which United members express their concerns directly to members of Congress, so attendees will have to choose.

We can’t help but think that the industry gains more from reaching to members of Congress than by chatting with the bureaucrats.

In fact, one of the lessons of this outbreak is that the trade’s traditional government relations efforts, which have heavily focused on members of the ag committees, need a reformation to deal with a day when FDA supervision of the trade’s food safety efforts is a reality.

We need to build relationships with every Senator and House Member who has oversight responsibility for Health and Human Services. That should be top priority.

You can learn more about United’s Washington Public Policy Conference here.

And you can register right here.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Ethics And The FDA

Although the FDA has had any number of experts present at the various conference calls it has conducted, it has yet to include an ethicist. This is a significant problem.

Today every major medical center has a committee devoted to ethics. Every medical school has courses on ethics and there are many journals specializing in the field. A luminary named Arthur Caplan, who is now at the University of Pennsylvania, is the “Dean” of the field.

Commonly called bioethics, it is a big and interesting field at the intersection of philosophy and medicine. If you want to sum it up in a sentence, though, you could do worse than saying this:

The fact that a given course of action will produce the best outcome does not mean that this course of action is ethical or permissible.

So even if we posit that by blocking borders, bankrupting farmers, hurting distributors, putting laborers out of work and having consumers dispose of their food, FDA was doing enormous good in alleviating human suffering and reducing the spread of illness, it is not clear that FDA is acting ethically.

The people whose livelihoods and businesses are being destroyed are innocents; they are not guilty or culpable in any way. There is no ethical standard accepted in America by which the growers and their employees should be punished — even if it does some good.

In other words, we are told by CDC that there are about 5,000 people who die from foodborne illness each year, about 350,000 that are hospitalized and about 76 million that have lesser illnesses.

If we knew there was a God of Foodborne Illness, and all we had to do to placate him was to sacrifice the fortune of one farmer each year — burn his farm and money in a sacrificial bonfire and leave him penniless — we would all instantly recognize we couldn’t do it.

It offends our sense of ethics that an innocent person should be punished even if it would save many lives.

Yet this is precisely what FDA is doing with its actions, punishing individuals on the basis that it hopes to do the “greatest good for the greatest number” by reducing foodborne illness and if hundreds or thousands or tens of thousands of people get hurt in the process, well, the “greater good” of enhanced public health justifies it.

Actually this is wildly overstating the justification that FDA has for its actions — which is why there’s the need for an ethicist. Even if the FDA wants to justify its actions on this kind of crude utilitarianism, it still has to actually do the utilitarian calculations.

Yet FDA has done nothing of the sort. For example, we know driving cars has risks — 45,000 people die each year in America from auto accidents. So when the FDA advises consumers to throw out their tomatoes, a certain percentage of those consumers will make an extra trip in their cars to the stores to buy some new “not associated with the outbreak” tomatoes or another food entirely.

FDA has not released any calculations and almost certainly hasn’t done any, but it is entirely likely that more people died from driving additional miles to restock at a store or to eat an extra meal out of the house than would have died from eating their stock of tomatoes.

Much has been made of FDA’s apparent mistake in fingering tomatoes and, indeed, this kind of error points to a need for various institutional checks and balances to make such mistakes less likely.

Yet human error is always going to be with us so it is important that the actions of our government, with its enormous power, be circumscribed by some ethical limitations.

The problem, however, is that all the MDs and scientists running this outbreak investigation are constrained by nothing. They think the ends justify the means. Yet today in medicine no doctor can run a trial without getting approval of the medical school or hospital ethics committee. So the people at FDA should have to present their proposed course of action to an ethics committee that would be charged with giving voice to those who are not being considered in FDA’s action plans.

People have independent rights and the FDA simply has no right to treat them as collateral damage. We need an ethics-based reform to introduce these concepts into the decision-making process at FDA.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Sickness Multiplier Needs Closer Look

One useful thing to know in these outbreaks is how many people actually get sick and to what degree they get sick. The CDC has mentioned research that indicates that, typically, more than 30 people get sick for every person found to be sickened by a foodborne illness.

Yet the CDC’s Doctor Patricia Griffin, Chief of the Enteric Diseases Epidemiology Branch, also acknowledged that this research is based on illnesses not related to known outbreaks. She pointed out that the multiplier is probably much less in an existing outbreak as the widespread publicity probably leads people to pursue medical treatment earlier and more frequently. It also leads medical professionals to order appropriate tests earlier and more frequently.

Some patients are motivated just by the hope of getting well quicker and others may have dollar signs in their eyes thinking that there may be lawsuit out of all this.

In any case, we are left with virtually no information as to what multiplier should be applied to active and well publicized outbreaks. We don’t know if this outbreak has sickened 1,500 people or 50,000 people. In the absence of accurate information, many reporters go with the best they have and the caveats are forgotten or lost in the larger piece.

It is too late for this outbreak, but it seems as if some useful research could be done in this area. The CDC needs to have a research protocol ready to roll out at a moment’s notice so that next time an outbreak becomes well publicized, it can do some research to answer this question: What is the appropriate multiplier to use to determine the number of actual sick people vs. the reported sick people?

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

FDA’s Sacrificial Lambs

One of the lessons of this Salmonella Saintpaul outbreak is that, as an industry, we cannot allow individual industry members to be hung out to dry by the FDA.

We have been writing for months regarding the FDA Import Alert imposed on a producer of Honduran cantaloupes. The Import Alert was imposed on March 22, 2008 — almost four months ago. FDA and CDC inspectors have come and gone, samples have been taken with only negative results. Yet the Import Alert stands.

This is a reputable company; it has certifications allowing to sell to organizations such as Tesco in the UK, it is third-party audited and deemed a high enough quality producer to be allowed to pack under both the Dole and Chiquita labels.

The owners of this farm have bowed deeply before the FDA. Despite the fact that FDA found nothing wrong in its inspection of the farm, the owners have agreed to make every change requested.

What is also odd is that these changes requested are not requested of other growers. So when the FDA noted a telephone or electric wire over a part of the farm, it demanded that the wire be relocated lest a bird sit on the wire and contaminate the field.

Yet the FDA has not issued any public findings that no farm should have a wire over it. It is a rule for this farm and this farm alone.

Equally with water sources… Many growers all over the world use river water as a source. Despite numerous tests, the FDA and CDC found no salmonella in the river water used by this enterprise. Yet because of the “potential” for river water to be contaminated, the FDA made clear it would not lift the Import Alert if this farm continued to use river water. So the farm agreed to invest in a system to allow it to use only well water.

Yet, bizarrely, this requirement applies to this farm and this farm alone. The FDA has not issued any advisories that nobody should eat food produced with river water, nor asked retailers or restaurants to restrain from buying food produced with river water. In fact, the FDA hasn’t even banned others from using the water of this very river in Honduras.

On so many levels, the FDA’s behavior has been aberrant.

First, after the tomato snafu, why should we have any confidence the CDC fingered the right cantaloupe producer?

Second, even if the producer had a problem, it is obviously an episodic thing that can happen to any outdoor farm — a flock of birds in the wrong place at the wrong time. There is no reason to believe that produce from the farm next door is any safer.

Third, it makes no sense to impose specific requirements such as banning the use of river water or the existence of power or telephone lines over one farm in the absence of a finding of a differential threat that requires that particular farm to do something no other farm need do.

Finally, even now the FDA doesn’t lift the Import Alert. So the owners of this farm are left in a horrible position. At best the question is should they spend millions of dollars to plant a crop on the “hope and a prayer” that the FDA will allow it into the country?

Of course, many farmers don’t have the millions, and few banks will lend if they don’t see a market for the crop. So it may be out of the hands of the growers.

And for the most part, this grower has been alone. There have been no statements of support from PMA or United or from their brethren cantaloupe growers in California or Arizona. No industry institution has demanded the FDA lift this absurd Import Alert that endangers next season.

Perhaps the experience of this Salmonella Saintpaul outbreak will remind us all of John Bradford’s famous utterance, now commonly expressed as, “There but for grace of God, go I.”

Certainly the Florida tomato growers are starting to realize that the FDA is a ship unmoored, its leadership feels bound by no rules, its behavior unpredictable and it is exceedingly possible that unless enormous political pressure is brought to bear upon the FDA, it could well decide to not lift its advisory against eating tomatoes from south or central Florida before next season — just as it has shown no concern that the Honduran grower should lose out on its season.

If you are the positive type who searches for the silver lining even in such horrible circumstances, we can tell you one: the Pundit winds up making lots of new friends. We had a chat with one of them, Jonathan D. Rockoff of the Baltimore Sun, about this situation and he was the first to get it in print in the consumer press in a piece entitled Tomato Warning Protested.

The piece dealt with the trade’s desire to see the nonsensical tomato warning lifted and to get compensation from the government, but it also pointed out that much more damage can still be done:

Tomato growers are especially frustrated because they must decide soon whether to plant for the coming season. Growers don’t want to make the $10,000-an-acre investment if the warning persists and consumer demand remains low.

”If we don’t seed the crop, we’re out of business. If we do seed the crop and FDA doesn’t clear us, we’re out of business,” said Reggie Brown, executive vice president of the Florida Tomato Exchange, an association of growers and shippers.

Industry officials say the FDA’s inaction has forced them to seek help from Congress. Tomato farmers, distributors and retailers are trying to determine the precise amount of damages the scare has caused.

The tomato industry is also seeking changes to the government food safety system, including standards to follow when deciding when to issue a warning and retract it.

”This is one of the problems exposed by this outbreak: There are no clear standards,” said Jim Prevor, editor-in-chief of PRODUCE BUSINESS, a trade publication.

Indeed, the fundamental problem revealed by the way the FDA deals with these outbreaks is its arbitrary exercise of power. Now we have run pieces, such as Fix Suggested For FDA’s Vigilante System of Banning Product Through Import Alerts, which, via an interview with two attorneys, explains how the FDA’s conduct is now essentially lawless.

The very fact that we have no idea when or under what circumstances the FDA might lift its warning not to consume tomatoes from south and central Florida is, itself, evidence that the FDA is violating the American notion that our government is one of laws and not of men, a phrase John Adams himself immortalized in writing the constitution of the Commonwealth of Massachusetts.

Americans are not supposed to have to plead as supplicants before King Acheson for some kind of kingly disposition. The standards for when such a recommendation can be imposed and lifted should be non-discretionary, publicly known and subject to speedy judicial review.

Seeing the path ahead will not be an easy one. The Florida Tomato Growers Exchange has begun to prepare itself for the fight to bring rationality to the FDA; its first shot across the bow has been this letter:

Dear Dr. Acheson:

The Florida Tomato Growers Exchange seeks your immediate assistance in mitigating the future impact of the current Salmonella Saintpaul outbreak on our industry, when it is now clear that tomatoes grown by our producers are not the cause of the outbreak.

The prolonged investigation has caused serious chain disruption and massive economic losses to the entire North American tomato industry. Florida growers, in particular, were severely impacted at the end of their 2007-2008 season by the U.S. Food and Drug Administration’s (FDA) recommendation that consumers avoid eating certain types of tomatoes that the Centers for Disease Control and Prevention (CDC) associated with the outbreak. To date, however, FDA’s traceback investigation has failed to confirm any connection to tomatoes whatsoever, and certainly not Florida tomatoes. And now, the focus of the investigation has moved to certain types of peppers.

Yet, at this time, several counties representing thousands of acres of tomato production in Florida that where in production at the beginning of the outbreak are not included on FDA’s list of areas not associated with the outbreak. These counties have now been out of production for well over two months. It is virtually impossible for tomatoes from those counties to be associated with illnesses reported in June or July. And, it is certainly not possible for the fall crop to be implicated. We also understand that producers in other areas face the same challenge we do in clearing earlier production regions now that it has been shown that such regions could not still be contributing to the outbreak.

Florida growers are in the early stages of preparing for the 2008-2009 season. Important decisions are being made now regarding the fall crop. Among those are decisions regarding the seeding of transplants, which will have a direct effect on the number of acres planted.

If these counties are not cleared immediately, growers will soon find themselves in the untenable position of having to make significant financial decisions without knowing whether or not they will be able to grow and market their crop.

The Florida Tomato Growers Exchange respectfully requests that FDA immediately specify that tomatoes grown in the entire state of Florida could not have been the cause of this ongoing outbreak, and that you revise your consumer advisory to remove any of our production areas from concern.

Reginald L. Brown
Executive Vice President
Florida Tomato Growers Exchange

cc: Florida Congressional Delegation
FTGE Board of Directors

The key line in the whole letter? It is that “cc” to the Florida Congressional Delegation.

That is the Florida farmers’ way of telling the CDC and FDA that it is clear this has nothing to do with protecting public health. This is now about the CDC and FDA trying to cover up their own incompetence and telling the CDC and FDA that the Florida farmers are not going to allow themselves to be sacrificial lambs so that the MDs and PhD’s don’t have to acknowledge their own errors.

They have many medical doctors at both CDC and FDA, but the Florida farmers are getting ready to teach them a lesson in physiology: It turns out that men are not meat, the more you pound them, the tougher they get.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Pundit Mailbag — Processed Salsa
Not Suspected Of Salmonella… Yet

We’ve run a number of pieces in which we have speculated on the likely cause for this Salmonella Saintpaul outbreak. One of the possibilities we mentioned was freshly prepared salsa, such as is typically sold in the deli section of supermarkets as well as for foodservice applications.

This speculation brought a response:

The news from the FDA just gets harder to swallow each week — but I’m glad you’re covering it so thoroughly. The mainstream media is pretty much repeating the FDA/CDC press releases and wire service stories and not being meticulous with their facts. Even Saturday’s Wall Street Journal front page had a chart which could lead one to believe the actual illness cases are skyrocketing when in fact the confirmed diagnoses of past cases is what’s really piling up.

I write to ask a favor… please be sure, as you comment on the possibilities that fresh salsa might be the culprit, that you (too) be careful not to paint with too broad a brush. My company is one of the leading producers of refrigerated salsa, and we consider our products to be just as safe as cooked vegetable products. Consumers (and, in the case of your readers, the Trade) need to understand there’s a BIG difference between fresh salsas made at home or in a small restaurant, and the retail packages offered in a grocer’s deli or produce case.

The difference is in how our products are produced and what our products contain. We run a HACCP plant (we have for over a decade, and we take pride in it). Our tomatoes (and cilantro, peppers, etc.) get processed in effective sanitizers like Tsunami and Ozone, which have high lethality for Salmonella. We lower the pH below the kill threshold for pathogens (3.8-4.0 typically), and many of our products contain preservatives. We have a (successful) Salmonella challenge study, which validated the whole process. Our PhD food scientist evaluated the kill potential of each step in a hurdle sequence and mathematically equated it to pasteurization, which we think is the gold standard for food safety.

Homemade or kitchen-made fresh salsa doesn’t benefit from all those protective steps.

Our practices and procedures are typical of all our large competitors and are representative of most of the refrigerated salsa tonnage sold in the US. As an industry (refrigerated salsa), we’re producing safe products and we don’t want to be lumped into a general category of blame (“fresh salsa”) any more than the poor tomato farmers who have suffered through this problem for the last several weeks.

Helpfully, the FDA indicated their focus is NOT on “processed or cooked salsa” (per the text of the WSJ article), and I respectfully request that you make that clarification as you continue to (very professionally) cover this important story. If there’s still a risk out there from tomatoes, cilantro or peppers, consumers should be most concerned about fresh produce, not properly processed retail products.

— Doug Pearson
California Creative Foods

Doug is, of course, correct. Consumers have nothing to fear from “properly processed retail products” and, of course, we have no basis to indict any product. However, if the cause has something to do with tomatoes and if the outbreak goes longer, the implication of any particular farm with the outbreak is increasingly implausible. This will inevitably turn speculation to products produced in a food processing facility.

These types of products have the long, continuous production runs that correspond to continuous outbreaks. Their products often have wide distribution and can explain a large multi-state outbreak far better than one farm can.

Doug’s plant and procedures sound terrific, but it is the nature of manufacturing that mistakes can happen and if they do happen, the consequences may continue until the problem is noticed and rectified.

We bet that ConAgra Foods has a food safety department and its plants surely run under HACCP plans — yet all this didn’t stop Peter Pan and Great Value brand peanut butters from becoming contaminated with salmonella at a plant in Sylvester, Georgia. Here is how ConAgra Foods explained what happened:

“The company believes that moisture inadvertently entered the production process and allowed the growth of low levels of dormant salmonella in the environment that were likely present from raw peanuts or peanut dust,” states ConAgra Foods in a news release.

The broken sprinkler system and the plant’s roof, which leaked during an August 2006 rainstorm, are believed to be the sources of that unwanted moisture, Childs says.

“We are truly sorry for any harm that our peanut butter products caused,” ConAgra Foods CEO Gary Rodkin says in the news release.

Obviously we have zero reason to think any such problem has occurred in any food processing facility, much less a fresh salsa one.

Still, any plant can have something go wrong, and when it does the process that is equated to pasteurization gets thrown off or a contamination occurs post-process.

We empathize with Doug’s point; all this chatter can drive away customers who are avoiding an infinitesimal risk. Just ask the tomato growers. We hope that the FDA’s declaration that it was not looking at fresh prepared salsas helps the sales numbers and, most of all, we hope this whole thing is resolved quickly so that the cloud of fear and risk that is covering so many items can, in fact, be lifted.

Many thanks to Doug Pearson for his thoughtful letter and kind words.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Pundit Mailbag — Irradiation Safety
Clearly Demonstrated

We’ve run many pieces on irradiation, including one specifically on tomatoes, entitled Irradiation Holds Promise For Tomato Pathogen Reduction, which featured an interview with Dr. Anuradha Prakash at Chapman University. It was, however a mention in our interview with Michael T. Osterholm, PhD, MPH that brought this note:

I was pleased to read the frank and honest opinion of my colleague, Dr. Michael Osterholm, about the OPTION on irradiation to ensure microbiological safety of fresh produce, as posted in your website on 24 June 2008. I have spent more than 3 decades of my professional life to develop irradiation technology from its infancy to the point that its safety and effectiveness as a sanitary and phytosanitary treatment for food have been clearly demonstrated.

You may be interested in seeing a booklet on “Irradiated Foods,” published by the American Council of Science and Health, as well as my recent article (written before the outbreak of Salmonella in tomatoes) just posted on ACSH website: http://www.acsh.org/

Unfortunately, the produce industry (and to a large extent the meat industry) has shunned the use of irradiation to ensure the safety of their products. In case of fresh produce, it may have an excuse as the FDA has approved irradiation ONLY for insect disinfestation and delaying physiological growth in 1986. As mentioned in my recent article, the FDA has kept the petition for irradiation (as a sanitary treatment) for ready-to-eat food including fresh produce pending for about 9 years. To me, the FDA should be held accountable for its delay in approving irradiation as a sanitary treatment for fresh produce, as the technology could have been used to prevent many illnesses and deaths from consumption of produce in the past 8 years.

It is clear that research data have demonstrated that pathogens such as Salmonella and E. coli (0157:H7) can grow inside fresh produce such as lettuce and tomatoes, making external washing essentially useless. It is beyond my comprehension why the produce industry has not demanded and the FDA has not approved the use of irradiation to protect consumer health as it is the only effective technology to “pasteurize” fresh produce.

— Paisan Loaharanu
Adjunct Prof. of Food Safety
Michigan State Univ.
E. Lansing, Michigan
Former Head, Food and Environmental Protection
Joint FAO/IAEA Division
Vienna, Austria

The FDA should be ashamed of itself for failing to approve the produce irradiation petition for nine years. We’ve asked and have been told bluntly that the hold-up is political. That FDA sees little upside in approval — just some scientists and policy wonks. And FDA sees the downside as substantial as it will be ruthlessly attacked by various non-governmental organizations.

Although FDA’s behavior is inexcusable, we can’t say it has made much of a difference. In hamburger, where irradiation is approved, the sales of irradiated meat are tiny. Yes, Wegmans, as we have mentioned here, here and here, does sell the meat and apparently has decent business — still it is a small percentage of total sales.

Hamburger is much riskier than produce, so it is hard to see it taking off in produce if it is slow to take off on hamburger.

It does strike us that the industry as a whole would benefit from the offering of an irradiated option in supermarkets. First we suspect there is a market — as large or larger than that for organics — that might value the product and not only buy it but pay a premium for it. We also think the offering of an irradiated option for produce makes it very clear that consumers are electing to take on certain risks when they buy the non-irradiated field grown produce. These risks are tiny, and unless one has an immature or impaired immune system, it is mostly a risk of developing a bad stomachache.

There is some irony, though, in the FDA, with the left hand demanding zero tolerance on pathogens and with the right hand prohibiting the use of irradiation to get to that point.

We thank Paisan Loaharanu for his intriguing letter.

Salmonella Saintpaul Outbreak…
Steps Taken to Stop FDA’s Madness

Perishable Thoughts

The FDA and CDC are in control right now. With letters from the Florida Tomato Exchange and especially the one from Senator Tom Harkin, the message is going forth that this industry shall be heard.

It reminds us of the first speech Benjamin Disraeli made in the House of Commons. He was a novelist and literary man filled with radical ideas and so his speech was not well received; indeed he was heckled quite strongly.

But though Disraeli was new to Parliament, he was smart and dedicated to the right. He was confident in his position and felt he would one day prevail, so he ended his first speech in parliament with these words:

“Though I sit down now, the time will come when you will hear me.”

Benjamin Disraeli, Earl of Beaconsfield
Maiden Speech in the House of Commons
December 7,1837

Published in Selected Speeches of the Late Right Honourable the Earl of Beaconsfield, vol. 2, “Irish Election Petitions,” ed. T.E. Kebbes (1882).

Perhaps the powers that be at FDA and CDC need to understand that this time the produce industry will be heard from… that this wanton and pointless destruction of whole industries will be stopped… that as Disraeli promised: “…the time will come when you will hear me.”

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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