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Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Bob Backovich,
Industry Giant,
Passes Away

Just as we were going to press, we received sad news:

I don’t know whether you’ve heard the news that Bob Backovich passed away last night of a rare kidney ailment. He was truly one of the old lions of the industry. He precisely fit his nickname of “The Boomer”.

— Grant Hunt
Grant J. Hunt Company

Bob was a giant in the industry, Chairman of PMA, a leader in promoting nutrition education and, for the last 20 years, he never failed to write us at PRODUCE BUSINESS whenever we wrote about the need for quality product.

Bob helped us analyze the growth of retail bureaucracy in a piece for the Pundit.

We never spoke to him about this Salmonella Saintpaul outbreak, but we can imagine his distress at seeing healthy products disparaged by such an issue.

Our condolences to Bob’s family and friends.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Trace Back The Control Group

One hope for solving this problem and clarifying the cause of this outbreak came out in the FDA/CDC’s recent conference call. It was good news to learn that CDC was basically starting anew and doing new survey work with people who became ill after June 1, 2008. This survey work would involve additional questions and presumably build on learning from inadequacies in the initial investigation of those who fell ill in April and May.

Right now there are 179 people who say they fell ill in June, and this number will presumably increase as more reports come in.

What was shocking — and very disappointing for the produce industry — was word that even in this new investigation, CDC is not doing any traceback of the control group. This group consists of people similar in demographics to the ill people but who did not fall ill.

Our interview with Michael T. Osterholm PhD, M.P.H., focused on the necessity for doing traceback with the control group. Here is what Dr. Osterholm said:

…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.

Now whatever happened with the initial investigation, whatever judgments or considerations were made, this much is beyond dispute: It didn’t work.

A quote attributed to Albert Einstein defined insanity as doing the same thing over and over again yet expecting different results. So surely CDC should be open to enhancing its methodology. Certainly there is no way that doing a traceback on the control group could hurt.

We have Dr. Osterholm, a highly credible person with extensive experience, saying this is a necessity. This is from a man who was doing traceback in Salmonella investigations on tomatoes a decade ago.

So, we have a methodology that has not been working, a highly credible source suggesting a specific improvement in that methodology, yet when asked, CDC gave a simple response of no, it is not tracing back the control group.

This should be a major concern for the produce trade associations, which should be requesting that CDC add this to their methodology right now, while it still can, so that this post-June 1, 2008 survey will be more productive and more likely to produce an answer as to the source of the salmonella.

This CDC also needs to consider its dismissive manner. An issue such as this merits an explanation. In light of the failure of the last traceback and the input from Dr. Osterholm, if CDC doesn’t want to do a traceback on the control group, it should have the decency to explain why to the general public.

Does CDC lack the resources required? Does it have a substantive disagreement with Dr. Osterholm?

The people at CDC are hired by the citizens of America to handle this portion of their affairs. A decent respect for the people who pay the bills requires CDC to be more transparent in its decision-making process..

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

‘Produce’ Or ‘Food Items’

Although CDC’s Dr. Griffin last Friday said, “This is a produce outbreak,” to distinguish it from a tomato outbreak, CDC’s Dr. Robert Tauxe used a different word in an interview with USA Today. He said “we’re broadening the investigation to be sure it encompasses food items that are commonly consumed with tomatoes.”

Obviously there is a big leap from “produce” to “food items,” so CDC should A) use words more carefully to avoid confusion, and B) clarify this issue very quickly.

The big produce items that have been floating around are all linked to Mexican food. A quick glance at the CDC map of the outbreaks shows this is an outbreak focused on the Mexican food belt:

Texas, New Mexico and Arizona have over half of the illnesses, and other areas, such as Chicago, all have large Mexican populations.

In the same USA Todayarticle, a well known food safety expert speculates:

If not tomatoes, what else? “Something that people find difficult to remember but which is always served with tomatoes,” says Tauxe.

That would put salsa, jalapeno peppers, green onions and cilantro at the top of the list of potential culprits, says Doug Powell, director of the International Food Safety Network at Kansas State University in Manhattan, Kan.

Both Dr. Tauxe and Dr. Powell are correct, except there is no logical reason to limit it to produce. Tortilla chips and tortillas would also fit the bill and as they often come free at a Mexican restaurant or as an accompaniment to a dish, it is logical to think people might not remember them.

One gets the feeling, though, that CDC is just grasping at straws. It has no more reason to think it is any of these products than it is chicken. That is why they are so loathe to give up on tomatoes.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Getting Our Money Back:
Waive Sovereign Immunity

Dr. Robert Tauxe, M.D., M.P.H., was representing CDC on the most recent conference call. He is both smart and knowledgeable; he has contributed additional information to articles we have run on the Pundit, as you can see here.

During the CDC’s most recent conference call, he was at pains to point out the complexity of figuring out the cause in an outbreak such as this and so compared the role of the CDC to that of a detective.

Dr. Tauxe is both articulate and frank and so we accept his description. We, do, however, wonder if he has been reading the papers lately:

U.S. to Pay Millions in Lawsuit Over Anthrax Innuendo

The U.S. government will pay $4.6 million to settle a lawsuit brought by Steven Hatfill, a former U.S. Army biodefense researcher who was intensively investigated as a “person of interest” in the deadly anthrax letters of 2001, the Justice Department announced Friday.

The settlement, consisting of $2.825 million in cash and an annuity worth $1.8 million that will pay Hatfill $150,000 a year for 20 years, brings to an end a five-year legal battle.

Hatfill, who worked at the army’s laboratory at Fort Detrick in Frederick, Maryland, in the late 1990s, was the subject of a flood of news media coverage beginning in mid-2002, after television cameras showed FBI agents in biohazard suits searching his apartment near the army base. John Ashcroft, then the attorney general, later called him a “person of interest” in the case on national television.

In a news conference in August 2002, Hatfill tearfully denied that he had anything to do with the anthrax letters and said irresponsible news media coverage based on government leaks had destroyed his reputation….

Mark Grannis, a lawyer for Hatfill, said his client was pleased with the settlement.

“The good news is that we still live in a country where a guy who’s been horribly abused can go to a judge and say, ‘I need your help,’ and maybe it takes a while, but he gets justice,” Grannis said….

“As today’s settlement announcement confirms, this case was botched from the very beginning,” Holt said. “The FBI did a poor job of collecting evidence, and then inappropriately focused on one individual as a suspect for too long, developing an erroneous theory of the case that has led to this very expensive dead end.”

The parallels to the Salmonella Saintpaul outbreak are pretty clear. A botched investigation, with the CDC failing to do control group tracebacks, led them to inappropriately narrow their focus to tomatoes prematurely.

There is, however, a difference. In both cases, the government, acting as a detective, came to a conclusion. In the case of the Anthrax situation, the government violated all the procedural safeguards put in to protect victims against the capricious use of governmental authority.

So the detective is obligated to present his case to the prosecutor… if the prosecutor does not think the case strong enough, it goes no further. If he thinks the case has merit, the prosecutor has to persuade a grand jury to bring an indictment. If the grand jury won’t indict, the case goes no further. Then there must be a trial and a judge or jury must be convinced. Finally there are several opportunities for appeal.

This is a very difficult and expensive system. However, we, as a people, are skeptical of governmental authority and so would not accept a system whereby the detective gets to also be the prosecutor, grand jury, judge and jury and appellate court on his case.

Yet this is precisely the way the CDC/FDA work on food safety outbreaks. Without any checks on their judgment or power, they do what they please regardless of the cost to others. In this case, it’s the cost to the tomato industry — although by vaguely implying other produce items may be at fault, they are already spreading the costs to other items as consumer confidence is surely being diminished.

Now we have suggested various plans to reduce the likelihood of a bad decision as well as to limit the discretionary use of governmental power. For example, we proposed the use of a Team B approach, modeled after a CIA effort to improve analytical quality and avoid mistakes.

Another way to make less likely mistakes such as we have seen in the Salmonella Saintpaul investigation is to use the power of the courts.

Right now the problem is that CDC and FDA personnel can be horribly wrong, yet neither the organizations nor the people involved will experience any consequences.

In the current case, hundreds of millions of dollars of losses have been incurred with a very dubious benefit to public health. If tomatoes are not the cause, then the losses had no public health benefit at all.

Now in the case of the anthrax “person of interest,” the government settled a lawsuit without admitting guilt. Presumably the government wouldn’t pay $4.6 million if it didn’t think it was in the wrong.

Now the question is where do the tomato growers go to get their compensation?

One possibility is for industry to ask Congress to waive the doctrine of sovereign immunity — which generally precludes suing the state. This would open the door for an industry lawsuit against CDC and FDA.

This would have three beneficial effects:

  1. Those who lost money due to the way CDC and FDA handled this matter would have an opportunity to get it back.
  2. The discovery process would reveal many problems in CDC and FDA, and we could use that information to build a better food safety system.
  3. There would be negative consequences for having made a bad decision, which will serve as a useful tonic to improve future decision-making.

What is clear is this: The detectives at CDC cannot be allowed to become some fanatical Inspector Javert relentlessly pursuing Salmonella or other pathogen without regard to cost. One good way to ensure this would be to make sure mistakes have consequences.

A Congressional waiving of sovereign immunity would be a fine way to teach that lesson.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

FDA/CDC Violate
Their Own Speculation Policy

FDA and CDC have made a point that they don’t release their speculations. So, for example, neither organization will name any other item, beyond tomatoes, that they are considering as the source for the Salmonella that has spread in this outbreak.

This is a reasonable enough policy, if it is followed consistently. Last Friday, however, when CDC’s Dr. Griffin announced that this was a “fresh produce” outbreak, we think she violated the same policy.

If CDC doesn’t know with sufficient certainty what item it is willing to publicly declare, then, obviously, it doesn’t know what particular category — such as fresh produce.

Remember, items such as guacamole or salsa can be manufactured items produced in food processing plants. They are not fresh produce.

By announcing that it is a fresh produce outbreak but then refusing to define the items of interest, they implicate the whole industry.

Now the fear — quite a reasonable fear — is that if the FDA and CDC say they are looking at jalapenos or cilantro, people will take a “better safe than sorry” attitude and avoid the products.

But, having defined the problem broadly as “produce,” consumers may start to take a similar attitude toward the whole department.

It is another example of sloppy management of the outbreak communication effort.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Four Talking Points
For Dr. Acheson To Consider

Dr. David Acheson, FDA’s Associate Commissioner for Foods, devoted a part of the Tuesday evening press conference to looking to the future and ways to do things better. It was truly thin gruel, and in many ways highly insulting to the produce trade.

First, he suggested the possibility of an “interagency task force,” which pretty much made us yawn. It is shocking to learn they don’t have one already. What they really need, though, is not so much: “better coordination” but someone in charge. Think Dwight D. Eisenhower in World War II. He didn’t have an ”inter-army task force” with the British; Montgomery was under Eisenhower’s command. If next time one person doesn’t come out and say, “I am in charge of the federal government’s actions regarding this outbreak,” we will have failed.

Second, Dr. Acheson gave this pointless oration on the “legal and ethical” obligations of the industry. In the first place, the guy has some nerve. Where does he come off lecturing the industry about its ethical obligations? Who does Dr. Acheson think he is — Moses? Jesus Christ? Muhammad? Buddha? Aristotle? On what basis does he assume he has the special competency to dictate ethics to industry members? He frankly owes the trade an apology for his presumptiveness.

Why doesn’t Dr. Acheson give a speech reflecting on his own ethical obligations and discuss how bankrupting tomato farmers, depriving migrant workers of their source of sustenance and urging poor people living on food stamps to throw out perfectly good food comport with his own ethical obligations?

It was a truly disgusting line. The Secretary of Health and Human Services should take him to the woodshed and remind him that he is not the moral superior of industry members. If members of the trade require ethical guidance, they are quite capable of getting it from their archbishops, not the Associate Commissioner for Foods of the FDA.

Beyond that, the repetition that industry members have both a legal and ethical obligation to provide food that is safe, wholesome and free of contamination would have been more helpful if it showed any evidence of serious thought.

That food ought to be safe is unobjectionable. So should cars, airplanes, trains and whatnot. But we don’t define “safe” in these contexts as meaning never an accident.

Throwing into his oration the notion that the industry has an ethical and legal obligation to produce food “free of contamination” is a sign that Dr. Acheson is engaging in cant rather than a serious assessment of the situation. Yes, that is how things have been interpreted legally, but there is a real question as to whether that makes any sense as a public policy.

In fact, there are serious trade offs between the cost of enhancing food safety and the ability to provide the world with low cost fresh food. Serious people now realize that we have to abandon the delusion of a zero-tolerance policy.

It is in many ways a shame that the industry confronted these issues in the context of the spinach outbreak of late 2006. We were dealing with processed product and dealing with product that the industry elected to market as “no need to wash” and “ready to eat” — those marketing phrases carry with them additional obligations to consumers.

However, growers of bulk, field-grown commodities are offering the world food raised in the earth and exposed to all elements. If consumers are really concerned about safety, perhaps because of a compromised immune system, they should cook the food well and not eat it raw.

Ethical obligations are — Dr. Acheson’s pronouncements excepted — complex. One farm technique will lead to deaths by starvation because people cannot afford the food; still another may produce plentiful food, but the occasional foodborne illness will afflict.

There are also other ethical obligations — say truth-telling — and so the industry must make certain, as we discussed here, that we are honest when we market product to those with immature or compromised immune systems.

Law is also a complex subject. The whole legal system in this area is best understood as the way society elects to compensate the people damaged by society’s unwillingness to pay the price to grow everything in an Intel-like “clean room”

One of the most important lessons of this outbreak is that we can’t leap to action. There are thousands of cases of Salmonella every month. The FDA/CDC have adopted a bizarre position. As long as they don’t see an illness, everything is OK, but if an illness happens to be brought to their attention, they will pursue the source more diligently than the crusaders pursued the Holy Grail.

The future must be built upon reasonable expectations for the prevalence of pathogens and then much effort to continuously make food safer and safer.

Third, we have come to wish that Dr. Acheson would just stop talking about the produce industry. Every time there is one of these calls, he comes up with some new tidbit that he shares with all the reporters. It is not typically that he is wrong, but his information is out of context and atypical. It is as if a Martian came to the earth and we educated him on the planet by having Ripley’s Believe It or Not make a presentation.

This most recent call, Dr. Acheson blamed the industry for the slowness of the traceback, claiming that “typically” the traceback records are maintained on paper as opposed to electronically. He basically portrays the produce industry as a bunch of hicks without computers.

How could this possibly be true? We know Wal-Mart is involved because New Mexico named them. Wal-Mart probably accounts for about 25% of all tomatoes sold at retail, and every single one of its suppliers has a computer, and they are all on Retail Link.

The big fast food chains, such as McDonald’s, Burger King, etc., certainly do not buy from anyone without a computer, and they run audits to check traceback ability. So, what is Dr. Acheson being told?

In addition, as revealed in an interview we ran here with Jim Gorny of the University of California, Davis, it is the epidemiology that is slow, not the traceback.

We are not saying that the industry can’t do better on electronic record-keeping and enhanced traceability. It can and, of course, we are working on it with a whole initiative in this area. But to say that this is “typical” seems highly unlikely.

Fourth, Dr. Acheson’s final point was to urge Congress to give FDA the authority to establish mandatory “preventative controls” as was called for in the FDA’s Food Protection Plan produced last November. Mandatory preventative controls is referring to the ability to create rules requiring producers to observe certain conduct — say put traps ever 50 feet — as opposed to inspect for safety after the production is done.

We have no particular objection to this. As we mentioned here, though, we think it is a bit of red herring. It implies that this outbreak is a function of growers refusing to do the right thing — a proposition for which there is, literally, no evidence.

What actually concerns us, as we mentioned here, is that FDA treats all growers the same. No amount of ”preventative controls” exempted a grower from the FDA’s advisory for consumers not to eat certain types of tomatoes from certain places.

If the FDA really wants to enhance food safety in the future, it will look carefully at revising this approach. Had FDA only said that retailers and restaurants should exclusively buy tomatoes from producers that are third-party audited to meet X standard, it would have encouraged massive investment in food safety in all sectors of the produce trade.

As it stands the message is, “Don’t bother!” That is dangerous.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

FDA’s Erroneous Statements Clarified By California And Florida Tomato Leaders

As Dr. Acheson has been learning about the produce industry, we wanted to investigate the relevance of some of the points he has been discussing. We asked Pundit Investigator and Special Projects Editor Mira Slott to find out more. She turned to Ed Beckman, President of the California Tomato Farmers and Reggie Brown, Manager of the Florida Tomato Committee and Executive Vice President of Florida Tomato Exchange & Florida Tomato Growers Exchange, for insight and information:

Ed Beckman
California Tomato Farmers
Fresno, California

Q: FDA has made a few claims in recent press briefings. Hoping you can comment on their accuracy, clear up any confusion, and put these issues in context relative to this particular outbreak and tomato production in general, can you comment on the following statements made by the FDA?

1. Mexican tomatoes get shipped to Florida for national distribution.

2. Up to 90 percent of tomatoes are repacked.

3. Tomato fields often stay in production for many months.

4. One giant national repacking facility could be taking in both Florida and Mexican tomatoes and shipping them all over the country.

5. A reporter from the San Francisco Chronicle asked if it was common practice to reuse the boxes these tomatoes are in, and whether that be a vector to transmitting salmonella. Dr. Acheson responded that he wasn’t aware of boxes being recycled in that way, but then continued: ”Certainly we’ve come across some indication tomatoes are taken out of the box for washing and put back in the same box. I can’t speak on how often that occurs but it has been reported by our investigators.”

A: 1. As to whether Mexican tomatoes can be shipped to Florida for repacking, I believe FDA made the comment that Mexican tomatoes are shipped to Florida, repacked, then shipped to Mexico — which is not factual.

2. That 90% of the tomatoes are repacked — no, not factual. As the second largest cooperative in the US, producing over 750 million pounds of tomatoes, this is not an accurate statement. FDA is making a general assumption that may be based upon earlier studies focusing on mature green shipments. However, I’d question the accuracy of the 90% figure when applied to mature green tomatoes. That’s not true of our membership. Certainly, that figure does not apply to vine ripe or roma tomato production or greenhouse beef tomatoes.

3. As to tomato fields staying in production for many months — yes, that is possible but may not be relevant if FDA is looking at mature green tomatoes. Vine ripe, greenhouse and shade cloth production can all remain in production for 20 weeks or more. This is due to the indeterminate nature of the plant, which continues to grow and produce tomatoes over many weeks. FDA’s statement, while true, is not accurate when characterizing mature green tomato production in Florida, California, and other states. In California, our mature green fields are picked once.

4. As to “giant” repackers. There are a number of repackers with multiple facilities and some who have clients that may be well over a thousand miles from their central location. My concern is that many of the press briefings and resulting media coverage focus on the ever-rising number of states — 36 states plus DC — when the focus should be on the actual cluster locations. We know those to be primarily in Texas, with secondary clusters in New Mexico, etc. If one looks at the location of the clusters, the question is raised as to the validity of any statement that would suggest a “giant” repacker is to blame, meaning, associated with distribution into all states.

As noted previously by several individual states, their reported illnesses are the result of people traveling to/from the cluster areas. Thus, it would be more appropriate to focus not so much on a “giant” repacker, but rather, on the suppliers into the cluster region. After all, consider the percentage of illnesses in Texas as compared to all other states. In such a context, is the concept of a “giant repacker” appropriate? The statement raises more questions than it seeks to answer.

5. FDA’s response is correct. In California (and Florida), there are regulatory provisions that prohibit the repacking of tomatoes into other than the original container. However, the problem is that in other states, tomatoes could be repacked into a used container that was not the original container.

Beyond your specific questions, there is the issue of the FDA expanding their investigative scope beyond tomatoes. This takes us back to the first days of the investigation in late May, when FDA raised the issue of fresh tomato products including salsa and guacamole both to industry and to the general public as possible sources of the outbreak.

That message was lost, as FDA’s messaging on specific types of tomatoes that they viewed as safe was all too often the primary messaging. As a result, the media, and many others, focused on the easily identified product… that being whole tomatoes. While we witnessed whole tomatoes being removed from store shelves, in many of those same stores, fresh salsa remained on the shelf.

My greatest concern with the FDA press conference was their statement related to what they viewed as inadequate trace-back within the fresh tomato industry. We were left with the impression that the tomato industry (in general) is somehow at fault and needs to modernize. As to the implementation of advanced trace-back programs, one needs only look at the efforts of Florida and our membership on this issue over the past years.

Revisions to the California Ag Code enacted several years back required growers and shippers to enact trace-back programs; California-based repackers are required to maintain original grower/lot identity in their finished product and if they do not, the product can be removed from the supply chain. In 2006, our membership enacted mandated regulations that go beyond those provided under the California Ag Code. The new Florida statute also provides strict trace-back requirements throughout the supply chain. While there will always be the need to improve trace back throughout the supply chain, such generalized comments (as made Tuesday) only create more doubt among consumers as to the safety of fresh produce. That’s unfortunate.

Reggie Brown
Executive Vice President
Florida Tomato Growers Exchange
Maitland, Florida

Q: FDA’s Dr. David Acheson says that tomato fields often stay in production for many months. Is this true?

A: Depending on the production system being used, if the tomatoes are in a protected culture system. This would relate to indeterminate tomato varieties typically grown in a greenhouse or protected system. I know of some indeterminate tomato varieties planted in December in Canada, harvested in late spring and in production through late November. The plant may be 40 feet long.

Q: But do these long production schedules apply to tomatoes grown in the field?

A: There are tomatoes grown in the field that could be harvested for an extended period of time. The traditional indeterminate tomatoes grow indefinitely in terms of a continuously growing vine, but are typically greenhouse or protected crops in certain parts of the country, mostly in the west and arid climates of the country.

We in the East and in most cases in the West, grow a determinant typ. The tomato grows so many leaves tall and stops growing. There are some indeterminate crops in California on stakes, but most are determinant varieties on the ground and virtually all in the East are determinant.

The bulk of tomatoes grown in Florida are very short-term. There would be some indeterminate crops grown in Mexico. The other types are determinant, relatively short term crops from a harvest standpoint, somewhere between four and six weeks depending on market conditions. It could be three weeks at certain times in Florida. The tomato types involved in the investigation are determinant and would fit in the category of short term harvests of just a few weeks at most.

Greenhouse tomatoes have a harvesting life of at least six months or longer. Even in cases of indeterminate field crops, they wouldn’t have that longevity in the field and may go two or three months at most depending where they are grown.

Q: Dr. Acheson also says that up to 90 percent of tomatoes are repacked. Is that your estimate?

A: I don’t believe that number is accurate. I’m not sure what percentage it would be, but 90 percent sounds extremely high. What is more disturbing is the way FDA throws around erroneous information as facts when it has no basis for making the statements.

Q: FDA says that Mexican tomatoes get shipped to Florida for national distribution. Is that a plausible scenario?

A: It is possible some tomatoes from Mexico are shipped to Florida and may get repacked and distributed. But under federal law, the Tariff Act and Florida state law, the identity and origin would be maintained. It is physically possible to mix Mexican and Florida tomatoes, but it would be misbranding and violate the Tariff Act.

During the period of January and February, we had concerns that some Mexican product coming into Florida was packed and misidentified as Florida product. This would be a violation of state law and the Tariff Act, and if we’re aware of it, it can be dealt with under existing legislation. Product from Mexico may be re-handled in Florida if there is a scarcity of product; it’s an availability issue. But shipping tomatoes back and forth is completely illogical based on operational logistics and trucking costs. It doesn’t make any sense whatsoever.

Q: FDA is looking at the possibility that one giant national repacking facility could be taking in both Florida and Mexican tomatoes and shipping them all over the country.

A: The whole principle of a repacking operation, even companies with large market shares, is to have multiple facilities distributing to limited areas for product quality control, freshness and reduced transportation costs. This lack of understanding at the FDA is absurd. This is nothing new. We’ve been working with them three years now. It is bizarre that they act as if this is the first time they’re learning about these things. Did they have a case of amnesia?

What angers me the most is for FDA to imply the industry has antiquated record-keeping procedures. That is a total misrepresentation of reality, an unfair indictment of our industry. It’s the FDA people holding the paper and pencil. FDA is doing a disservice to the repacking industry serving all the major brands by implying that it does not have the professionalism or necessary tools for trace back. You know darn well all the large fast food chains won’t buy from anyone without accurate trace back abilities. The FDA could have gone to Wal-Mart at the start of this investigation and the retailer would have traced back product in record time.

Now they’ve expanded the investigation to other produce items associated with consumption of tomatoes, but won’t say what items they’re investigating, essentially implicating the entire produce industry. Ultimately they’ll find a problem in a processing facility. They didn’t have a problem bringing down the tomato industry, but now all of a sudden they’re taking the moral ground.

Q. A reporter from the San Francisco Chronicle asked if it was common practice to reuse the boxes these tomatoes are in, and whether that could be a vector to transmitting salmonella. Dr. Acheson responded that he wasn’t aware of boxes being recycled in that way, but then continued: “Certainly we’ve come across some indication tomatoes are taken out of the box for washing and put back in the same box. I can’t speak on how often that occurs but it has been reported by our investigators?” Could you comment on this?

A. There may be some repacking of tomatoes to the same boxes the tomatoes were shipped in. There are some tomatoes that are packed in the field into used boxes, but it is a relatively small percentage of the product. This is a practice that would be prohibited under the Florida Tomato Food Safety regulations that went into place July 1, 2008.

We thank both Ed and Reggie for helping to clarify these issues. We appreciate the clarification and are sure the FDA will as well.

We do see two points for industry improvement:

  1. The process is excessively driven by Florida and California state laws. It seems that we need a more uniform national standard so that growers and repackers outside of Florida and California are on the same page. It is not appropriate that food safety should be addressed just where there is a production constituency.

  2. We need better data on the industry. There seems to be little hard data on the use of repackers and the scope of their distribution. We should have the data to answer these questions.

We note, with agreement, the outrage at the FDA’s attempts to portray the tomato supply chain as a bunch of hicks who never heard of computers. That sounds like FDA’s own field people making excuses for their own slow effort.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Consumer Press Catching On

It is said that every cloud has a silver lining, and if it can be said that there is an advantage to the length of time this Salmonella Saintpaul outbreak is continuing, it is that the consumer press is starting to become significantly better. The questions they pose to the FDA and CDC officials are becoming more probing and more skeptical.

We take a little credit for this. We’ve spent well over a hundred hours speaking with consumer media since this outbreak started. You may have caught the occasional mention of the Pundit in articles discussing the outbreak in places such as USA Today, the Baltimore Sun, the San Diego Union Tribune, the Miami Herald and BusinessWeek.com or caught us on the Lou Dobbs show on CNN.

What is not always obvious, though, is that this is a big job. We might abandon our family on a Saturday or Sunday and speak to a reporter for an hour bringing him or her up to speed on the industry — and then get only a one-sentence mention in an article — or not be mentioned at all.

The problem is not that there aren’t plenty of resources to educate consumer reporters about the industry. The problem really is that few reporters for major dailies have agriculture as a full time beat anymore — by our count, in fact, there are only four left in the whole country. And, even for them, produce in general and any item in particular is a very, very minor part of their jobs.

So the problem is if we offered a two-week intensive course on the structure of the tomato industry, when there is no outbreak nobody would want to take it.

This means that when the FDA and CDC announce an outbreak, most of the reporters are novices at food safety outbreaks, certainly on the particular commodity. They thus tend to rely heavily on “official sources” and are not educated or trained sufficiently to really evaluate the veracity of those claims.

Thus the questions tend to be inane initially. Many of the reporters are quite smart, though, and practiced at being skeptical, so as the outbreak goes on, they start seeing internal contradictions and, as they talk to more people, they start to realize there are other points of view.

When we publish something like our important interview with Michael T. Osterholm, PhD, MPH, we not only make his views available to the industry but, also, raise his profile as a source. So, all of the sudden, after we ran that interview, quotes from Dr. Osterholm started appearing in many consumer publications.

If you listen to the official FDA/CDC press conferences, you begin to hear a shift in which the reporters start to object to being snowed, to having information withheld, to being patronized. This is all very good for the industry. When this outbreak is over and we insist on an investigative report and Congressional hearings, it means we are more likely to have a press corps that will understand the issues at stake and be more engaged in the outcome.

So our silver lining for a very big cloud is that it is raising the “produce literacy” of a whole contingent of consumer reporters. That more educated press corps may well prove an important asset in the months and years to come.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Plea For CDC To Release Sickness
Details And Origin Of Purchase

There are two important pieces of information that the CDC needs to release so we can help it make sense of this outbreak.

The first is demographic information, particularly, the ethnic makeup of the sick people.

The second is the percentage of people who believe they became sick after eating at a restaurant as opposed to those who believe it was from food they purchased from a retail store.

Ethnicity is very helpful in identifying what foods we should be looking at. If the outbreak is composed of mainly elderly Jewish people, then tomato is often eaten with lox or nova salmon and cream cheese on a bagel.

If we are talking about new Mexican immigrants, we can pretty much not worry about the bagel and lox.

Retail and restaurants often have completely different products with a completely different supply chain.

All this information is not confidential — there is no reason not to release it, it is just a ”habit of secrecy” that we have to encourage FDA and CDC to overcome.

Solving these outbreaks fast is both a public health imperative and vital for industry. The single best way to do that is to share information with bright people around the world.

Industry efforts after this outbreak is over should focus on creating a “default position” of transparency. All information should be released unless there is a compelling reason not to release it.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

CDC Makes One Step Forward And Two Steps Back In Mapping Illnesses

It is has been said that there is no force more powerful than an idea whose time has come. So, here at the Pundit, we keep pushing good ideas and, in fact, often play a role in bringing about positive change.

Just recently, for example, our piece, CDC’s Map Of Ill Persons Could Use Some Improvement, suggested some flaws with the way CDC has mapped illness outbreaks — namely that it counted one sick person in a state the same as thousands in another state. The only options in CDC’s previous maps was for a state to be white — meaning no sick people in that state — or green, meaning at least one sick person in the state.

This made every outbreak quickly look national, although in many cases the one sick person in a state may be a tourist who visited the area of the outbreak.

In the piece we put up a few alternative maps and promised to keep working on finding a better way to graphically represent an illness. Fortunately, they were listening at CDC and came up with a more effective and accurate visual.

Unfortunately, they have already changed it again to be less informative. We are not sure why.

The old style map looked like this:

Then on June 23, 2008, the CDC switched to this map:

We thought the above map was a big improvement. It is a little hard to see on these small renditions though easy to see at the link. By putting the numbers in each state and changing the color based on the number of cases per million population of the state, the map presented a much more accurate and useful map of the outbreak.

Inexplicably, though, CDC abandoned this concept and went with a different idea:

The big switch here was the abandonment of showing the colors by the number of cases per million population. We think this is a big mistake. Saying that a place has 85 cases doesn’t tell you much. In North Dakota, that number would represent a very big outbreak; in California, not so much.

In addition, just showing that per million denominator would put things in perspective. If we are talking under 2 cases per million population, that communicates a lot more information than just saying 18 people are sick.

In fact, we suspect that this denominator, with its useful role of putting into perspective the extent of any outbreak, so disturbed the “zero tolerance” crowd at CDC that the powers that be insisted it be changed.

They would rather position the CDC as a bulwark protecting Americans, all of whom are one bite of a tomato away from doom.

Of course, we don’t know why the change was made, but it speaks to a culture of arrogance at CDC. They just don’t understand that they work for the people, and the people are entitled to information and explanations.

We mentioned the other day how arrogant it is of CDC to not release the epidemiological curve on the grounds that information is incomplete when, of course, everyone at CDC studies incomplete data every day.

So, in making a switch on the maps — dropping this important denominator — a decent respect for the taxpayers of the United States would lead CDC to explain itself. That is doesn’t bother or feel that necessity tells us more about CDC than it might wish to tell us.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Pundit’s Mailbag — Plenty of FDA Incompetence to Go Around But TheProblem Is A Matter Of Politics, Says Marion Nestle,Esteemed Food Policy Professor

One of the great joys of doing the Pundit has been the opportunity to exchange ideas with brilliant people from across the globe. Today we are honored to receive a note from Marion Nestle, a woman who can only be described as an irreplaceable national resource on public policy as it relates to food and nutrition.

We say this not because we always agree with her policy prescriptions but because she is always willing to dialog; she recognizes intelligence and she brings to the policy debates a kind of common sense attitude that often gets lost when policy wonks stake out their positions.

Some see her as anti-business, but we find her to be open to discussion on the best way to advance our common interests. She certainly has been controversial but she is forthright and pays respect to her opponents.

She is a prolific author, weighing in with seminal books on food policy, such as, Food Politics: How the Food Industry Influences Nutrition, and Health and Safe Food: Bacteria, Biotechnology, and Bioterrorism and is co-editor of Taking Sides: Clashing Views on Controversial Issues in Food and Nutrition Her latest book is What to Eat.

She maintains websites, such as FoodPolitics.com, and blogs at WhatToEatBook.com. We’ve been honored to earn a few links from her when we’ve dealt with food safety and other public policy issues.

One of the biggest mistakes the industry can make is to circle its wagons and only talk to people who agree with the positions of the trade. To have credibility in the policy arena, we must have the courage to confront issues from a public policy perspective. We must also have the intellectual self-assurance to be willing to try to persuade those open to persuasion.

Inherently, the offerings of the produce industry always align the trade with those concerned about issues such as obesity. We need to do a better job of building on these commonalities of interest.

One always learns more by listening than by speaking, so let us listen to what Marion Nestle has to say:

I’m following your following of the tomato incident with great interest, to say the least. Your piece, What Would FDA Do With ‘Preventive Authority,’ raised important questions.

This one, I see differently. I don’t think the issue is totally FDA incompetence, although I agree there is plenty of that around. I think it is politics.

The Commissioner is a political appointee whose job it is to carry out the will of the administration. This administration doesn’t like regulation much and has made sure that the FDA can’t do too much of it.

Von Eschenbach got spanked when he asked Waxman for more money, and he sure hasn’t tried that again. Acheson would be fired if he spoke up, and he’s the best they’ve got, so it would be a shame to lose him.

My experience in government, limited as it was, taught me that the only way to maintain integrity is to have one foot out the door at all times and to be willing to be fired at a moment’s notice.

That’s a lot to ask of public servants. So what to do? Keep the pressure on, which is what you are doing. Thanks for doing it.

— Marion Nestle
Paulette Goddard Professor of Nutrition, Food Studies and Public Health
Steinhardt School of Culture, Education and Human Development
New York University

We certainly appreciate Professor Nestle’s kind words, and she can certainly count on us to “keep up the pressure” although to paraphrase Harry Truman — we just tell the truth and they think it is pressure.

There is a sense in which we can simply say we agree. Professor Nestle’s comments regarding her government service refers to a couple of years as Staff Director for Nutrition Policy and Senior Nutrition Policy Advisor at the Office of Disease Prevention and Health Promotion in the Department of Health and Human Services. The experience she gained from these government positions taught her that if you want to do what you think is right, you better be willing to be fired. This is true of pretty much all of life, with the exception of tenured professors.

When we wrote a piece for The Wall Street Journal entitled, The Roots of Editorial ‘Independence’, we wrote this: “Editorial independence is always a function of one thing and one thing only: an editor’s willingness to be fired.”

In this particular case, a willingness to be fired shouldn’t be that tough. The top people at FDA and CDC can almost certainly earn more money in the private sector. Some stay because of a genuine desire to advance public health, but a few too many are in love with the power.

What we think is interesting about Professor Nestle’s letter is that it speaks to a divide in the public policy community about how to respond to the obvious ineptness of the way this Salmonella Saintpaul outbreak has been handled.

On the one side is Professor Nestle and other policy advocates, such as Caroline Smith DeWaal of the Center for Science in the Public Interest. They see the FDA and CDC as inherently handicapped by the predilections of the Bush administration.

When FDA and CDC mess up, they may not quite excuse it but they sort of say “What do you expect? The Bush administration has starved the agencies of money, made clear it wants minimal regulation, and under these circumstances you are going to have the kind of performance you are seeing in this outbreak.”

These advocates want change — almost all advocate a single food safety agency — but, in the end, they see the problem as being primarily external to the agencies. Cure the rot at the top — they would say — and you will see big improvements.

There is merit to these arguments, although we think they significantly understate the necessity for personal responsibility.

All the players in this game are professionals, they are MDs, MPHs and PhDs, and they have an obligation to those professions to not cover up problems. So when in conference call after conference call, Dr. Acheson, FDA’s Associate Commissioner for Foods, explains that he will put out as many inspectors as necessary to handle this traceback, we assume he is telling the truth. If, in actuality, there are resource constraints that are slowing this process down, we would assume he would say that. If the penalty for saying that is he gets fired, we assume he would get fired gladly and demonstrate how serious the problem is that the administration won’t even allow such discussion.

Ironically, we would argue that the biggest impediment to regulation in the fresh produce industry is the zero-tolerance policy toward pathogens.

FDA can’t really regulate fresh produce because if it really tried to ensure zero pathogens on field-grown products, it would shut the industry down. So, inevitably, any regulatory scheme FDA proposed will, at best, only reduce the incidence of pathogens on produce.

Now normally, reducing a problem is a good thing. If a new director of the National Highway Traffic Safety Administration reduced auto accidents by 10%, we would give the director a medal.

Under the FDA’s zero-tolerance policy, it is of no importance. Under any plausible mandatory scheme, there will still be pathogens — and so the FDA, if it regulated, would be in a position during the next outbreak in which those reporters would be saying: “Well, Dr. Acheson, you have mandatory regulation of the produce industry. Is the problem that your regulations are inadequate or is your enforcement inadequate?”

Both PMA and United have endorsed mandatory federal regulation, as we discussed here, here and here. We don’t have mandatory federal regulation because the FDA would rather be blaming rogue tomato farmers than the adequacy of its regulation or enforcement.

We are not opposed to things such as a single food safety agency, and we want to budget to have a world-class scientific infrastructure. We think, though, that effective regulation of fresh produce starts with honesty.

If the FDA will abandon its zero-tolerance policy, we can actually make food safer. We should do studies to establish baselines for the incidence of pathogens on different products and then work to reduce that incidence in a series of multi-year efforts.

If they get hysterical every time they find some pathogen, we can’t regulate, we can’t make progress, we can scarcely discuss the issue. That is not a recipe for success.p>

Many thanks to Marion Nestle for helping us think hard about such important issues.

Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Pundit’s Mailbag — FDA’s Tomato Safety Initiative Revisited

On June 13, 2008, in the midst of the Salmonella Saint Paul Tomato Outbreak, one reader, either prescient or with a remarkable memory, thought to scan the Pundit archives:

I thought it was interesting to note the following archive article, one year ago today!

FDA Begins Tomato Safety Initiative

Jim Prevor’s Perishable Pundit, June 13, 2007

When it comes to food safety, so much of the focus of the produce industry has been on leafy greens that it is easy to forget there are plenty of other items with food safety issues to be dealt with.

The FDA hasn’t forgotten, however, and has announced that it will begin a multi-year Tomato Safety Initiative:

The Food and Drug Administration (FDA) will begin a Tomato Safety Initiative in the Summer of 2007. The Initiative is a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry.

FDA developed the Tomato Safety Initiative in response to recurring Salmonella outbreaks associated with fresh and fresh-cut tomatoes. The Initiative is part of a risk-based strategy to reduce foodborne illness by focusing food safety efforts on specific products, practices, and growing areas that have been found to be problematic in the past.

The Tomato Safety Initiative is modeled after the Leafy Greens Safety Initiative that was initiated in August 2006, in collaboration with the State of California’s Department of Health Services and Department of Food and Agriculture. This new initiative is fully consistent with the 2004 FDA Produce Safety Action Plan goal of minimizing the incidence of foodborne illness associated with the consumption of fresh produce.

Most tomato-associated outbreaks over the past ten years have been traced to product originating from the Eastern shore of Virginia and from Florida; however outbreaks have also been traced to Georgia, South Carolina, Ohio, and California. Accordingly, FDA, in cooperation with Virginia’s Department of Agriculture and Consumer Services, will begin the Initiative in July of this year, by visiting Virginia based tomato farms and packing facilities to assess their food safety practices and to what degree they implement Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs).

Assessment of a variety of environmental factors including irrigation water, wells, procedures for mixing chemicals, drought and flooding events, and animal proximity to growing fields will also be conducted during the farm and packing facility visits. Later in the year, a similar effort will be conducted in Florida coinciding with the production and harvesting season there.

Other components of the Initiative include continuing outreach with the industry at all points in the supply chain, facilitating and promoting research on tomato safety, and working with federal, state and local public health officials in disease detection and outbreak response.

By identifying practices or conditions that potentially lead to product contamination, FDA can further improve guidance and policy intended to minimize future outbreaks as well as ascertain future produce safety research, education, and outreach needs. The findings of the Initiative will be publicly shared upon completion of the effort, allowing the states and industry members to maximize their food safety efforts as well.

Here at the Pundit we’ve been aware of this issue and have discussed it in many pieces, including Pundit’s Pulse Of The Industry: Florida Tomato Committee’s Reggie Brown and a piece that included a lengthy interview with Ed Beckman, President, California Tomato Farmers, which was entitled Moving Food Safety On To Other Commodities: California Tomato Farmers Raise The Bar.

The positive thing about this FDA effort is that it seems to be a genuine search for knowledge — everything from recommended practices being implemented to searching for other factors that could cause problems which might require a change in what practices are recommended.

Fortunately, the tomato industry in both Florida and California has been pro-active on this issue. Let us hope their efforts are being implemented in other states as well.

Fortunately at Belair Produce, we were spared the rod as we had only had Florida product on hand. We were able to get certified by Wednesday June 11, 2008, in the afternoon and all of our clients were quickly back in business.

I sincerely feel our industry’s pain and aggravations. Special to note that Amy Philpott at United Fresh has been great to deal with and quite informative as to other official views. She now reads your Pundit as well as Joe Mayhew from Landry’s Restaurants…

— Rob Mumma
Senior Vice President of Business Development
Belair Produce, Inc.
Baltimore, Maryland

Many thanks to Rob for his letter and his efforts at boosting Pundit circulation. We especially thank him for reminding us that it was a year ago that the effort was launched.

One important buyer also sent us a note pointing out that:

The tomato industry in Florida and California deserve kudos for the voluntary steps they have taken to get their arms around food safety. We could not have said the same for spinach growers in September 2006.

Without a doubt this is true. Yet, the whole FDA initiative indicates we have just barely begun to understand the nature of the risk and how to avoid it.

One other thing… the FDA Tomato Safety Initiative, which is, as the FDA said in its release “…a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry…” What is obviously lacking is an international component.

In today’s international world, a problem in Mexico can crush farmers in Florida, California and elsewhere, so these types of initiatives need to look at the supply chain and make sure relevant countries are in the loop in our efforts to enhance food safety.

Once again, many thanks to Rob Mumma and Belair Produce.

Perishable Thoughts

It is a good thing for an uneducated man to read books of quotations. Bartlett’s Familiar Quotations is an admirable work, and I studied it intently. The quotations when engraved upon the memory give you good thoughts. They also make you anxious to read the authors and look for more.

— Sir Winston Churchill
My Early Life: A Roving Commission, 1930, Chapter 9
British politician (1874 — 1965)

Although Churchill was speaking about uneducated men, we have found that the world is so complex — there is so much to know — that we are all uneducated. The Pundit has long been a collector of quotations and has enjoyed them as windows to great ideas and the motivations and concerns of great men.

We’ve decided to share the collection by adding a “Perishable Thought” to the bottom of each Pundit, starting with this one. If you have a quote you would like to share, please send it to us. You can do so here.

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