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Perishable Pundit
P.O. Box 810425
Boca Raton FL 33481

Ph: 561-994-1118
Fax: 561-994-1610


email:
info@PerishablePundit.com

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SPECIAL ANNOUNCEMENT

FDA Expands List Of Mexican States Not Associated With Salmonella Saintpaul Outbreak

The FDA has expanded its list of places in Mexico that “HAVE NOT BEEN ASSOCIATED WITH THE OUTBREAK” to including the following Mexican states:

Aguascalientes, Baja California Norte, Baja California Sur, Campeche, Colima, Chiapas, Chihuahua, Distrito Federal, Durango, Guanajuato, Guerrero, Hidalgo, México, Michoacàn, Morelos, Nayarit, Nuevo León, Oaxaca, Puebla, Querétaro, Quintana Roo, San Luis Potosí, Sonora, Tobasco, Tamaulipas, Tlaxcala, Veracruz, Yucatàn, Zacatecas

This represents a substantial increase over the previous list which, in Mexico, only included Baja California Norte.

Although no FDA officials were available to speak with, the FDA has dropped from its web site any notice of special certificate requirements as exist for Florida. Presumably the normal export paperwork is thus deemed sufficient.

We will have a full issue out Monday but wanted to make sure that this information was in the hands of our readers as soon as possible.

For background on this outbreak you can consult our “hot topic button” on this outbreak here.

The FDA website on this outbreak, which you can consult here, now says this:

June 20, 2008: At this time, FDA recommends consuming raw red plum, raw red Roma, or raw red round tomatoes only if grown and harvested from the following areas that HAVE NOT BEEN ASSOCIATED WITH THE OUTBREAK:

Alabama

Alaska

Arkansas

California

Colorado

Connecticut

Delaware

Florida (counties of: Jackson, Gadsden, Leon, Jefferson, Madison, Suwannee, Hamilton, Hillsborough, Polk, Manatee, Hardee, DeSoto, Sarasota, Highlands, Pasco, Sumter, Citrus, Hernando, Charlotte)*

Georgia

Hawaii

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

New Hampshire

New Jersey

New Mexico

New York

Nebraska

North Carolina

Ohio

Oklahoma

Pennsylvania

South Carolina

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsin

Belgium

Canada

Dominican Republic

Guatemala

Israel

Mexican States (Aguascalientes, Baja California Norte, Baja California Sur, Campeche, Colima, Chiapas, Chihuahua, Distrito Federal, Durango, Guanajuato, Guerrero, Hidalgo, México, Michoacàn, Morelos, Nayarit, Nuevo León, Oaxaca, Puebla, Querétaro, Quintana Roo, San Luis Potosí, Sonora, Tobasco, Tamaulipas, Tlaxcala, Veracruz, Yucatàn, Zacatecas) New!

Netherlands

Puerto Rico

*Shipments of tomatoes harvested in these counties are acceptable with a certificate issued by the Florida Department of Agriculture and Consumer Services.

Consumers who are unsure of where the tomatoes are from that they have in their home are encouraged to contact the store or place of purchase for that information. If consumers are unable to determine the source of the tomatoes, they should not be eaten.

Consumers should also be aware that raw tomatoes are often used in the preparation of fresh salsa, guacamole, and pico de gallo, are part of fillings for tortillas, and are used in other dishes.

Types of tomatoes not linked to any illnesses are cherry tomatoes, grape tomatoes, and tomatoes with the vine still attached.

We hope this information makes this a more pleasant weekend for some of our readers.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

What Would FDA Do
With ‘Preventive Authority’

The FDA and CDC have held a series of conference calls and press conferences during the Salmonella Saintpaul outbreak and most are rather predictable.

Yet listening to FDA’s Dr. David Acheson, M.D., Associate Commissioner for Foods, speak on a recent call was rather shocking.

In response to a question, he pointed out that FDA had requested “preventative authority for high risk foods.” Since Salmonella is a serious illness and tomatoes are considered high risk, such authority would allow the FDA to mandate preventative measures.

As it happens, both United and then PMA have endorsed mandatory, federal regulation.

In a bid to raise regulatory confidence, we had endorsed mandatory regulation as well, but confess we have become less certain as we see the caprice with which FDA exercises its powers.

Yet what strikes us is that this is a bureaucracy hiding behind the skirt of a power claim with no merit.

Just look at this outbreak: A mere “recommendation” from the FDA and we know of not one chain in America, restaurant or retail, that is selling anything the FDA has recommended against.

This tells us that if the FDA had the foggiest notion of how to end all outbreaks, it doesn’t need “preventative authority” to make that happen. A simple FDA “recommendation” that retailers and foodservice operators not sell tomatoes that were not certified to a particular standard would surely do the trick.

Dr. Acheson was called on this and asked what “preventative measures” the FDA might like to impose. He hemmed and hawed and said that this would depend on the specific legislation and authority granted, etc., etc., etc.

We, however, would encourage Dr. Acheson to think expansively… and answer the question. Since, at this point, this would simply be a recommendation, this requires no legislative authority. The question thus becomes: What is FDA’s “dream plan” of “preventative action” for tomatoes — and all fresh produce items?

What plan would FDA impose if it could impose any plan it desired?

You won’t get an answer to this question, and it is important to understand why:

1) FDA is petrified to take a stand for which it could later be found at fault. If it actually lays out a plan of preventative measures and there should still be another outbreak, then Dr. Acheson will be called up before a Senate Committee and crucified.

This is why any FDA standard is always going to be very vague. They may say land should be fenced, but they will never define adequate fencing — how high, how deep, made of what? If a pig gets under the fence, FDA wants to blame the farmer and use the breakthrough as proof the farmer violated the standards by fencing inadequately.

2) Despite the size of this outbreak, tomatoes still are so safe that it will be very difficult to ascertain any improvement in food safety no matter what is done. We know of 48 people hospitalized during this outbreak. With 305 million Americans, this means that the odds of any American having gotten sick enough to require hospitalization as a result of this outbreak are 48 divided by 305,000,000 or .00000015737%

Because of this fact, FDA will be hard pressed to recommend changes that will cost hundreds of millions of dollars with virtually no improvement in safety. There can’t be much improvement because the tomatoes are so safe to begin with.

Dr. Acheson actually has some nerve demanding mandatory authority as if the industry has refused to implement some FDA recommendation.

If Dr. Acheson really wants the tomato industry to do something — instead of grandstanding about mandatory preventive control, loudly proclaiming “we need them, we’ve asked for them and we don’t yet have them” — he should just speak up and tell us what he actually wants tomato farmers to do.

He doesn’t do so because A) He doesn’t want the responsibility, and B) He hasn’t a clue what tomato farmers should do to make crops safer.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

What Does the Word ‘Ongoing’ Mean?

Perhaps our biggest Pundit Peeve with this whole Salmonella Saintpaul/Tomato problem has been the lack of clarity with which CDC and FDA chooses to communicate to the public.

For example, the FDA and CDC keep characterizing the outbreak as “ongoing” without defining that term.

Now to a consumer, the word “ongoing” means “I am still at risk.”

Yet the FDA and CDC can’t really think that. We know of no retailers or restaurants selling tomatoes that are not on the FDA “Approved” list. So, if FDA believes in its list, one has to say the outbreak is over in the United States — with the possible exception of some consumers who may have old tomatoes or old fresh tomato products in the house.

We think what CDC and FDA mean is that the outbreak is “ongoing” in that they expect the number of sick people reported to increase as a result of state labs getting numbers to the CDC. These new files may even push the end date of the onset of illness from June 5 forward a few days.

FDA has not announced that it is aware of anyone selling tomatoes not on the recommended list. So if the recommended list is good, the tomatoes out there are good. So consumers run no risk as far as this outbreak goes.

Which to any consumer would mean the outbreak is over — not ongoing.

Why, though, should we need an interpreter to understand what CDC and FDA are saying? Why should CDC and FDA elect to speak in a way that causes consumer confusion? It makes no sense.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

The Glorification Of Traceback

If you listen to the pronouncements of the FDA, you see them as heroes searching with great difficulty to trace back the Salmonella outbreak on tomatoes to its source.

And, indeed the job is a difficult one. Remember we only have 243 people who have been interviewed. Assuming half actually remember something useful, we are out searching for 122 servings of tomato — and remember some of the servings can just be a slice on a burger. The problem is, during the time CDC says this outbreak was active, Americans consumed over four billion servings of tomatoes.

So this is some job.

One wonders exactly how much it matters.

In a factory-sourced food or drug, the importance is obvious. A dripping pipe will continue to drip.

But it is not common for the FDA to trace back and discover some horrible permanent flaw such as drawing on sewage water for irrigation. Most of the time the traceback brings us to a field and we learn that, it seems, there was some salmonella on that field a few months ago.

In fact, the investigations are often ridiculous because in search of something wrong to correct, the FDA will create special rules for that one field. So they may find a telephone wire crosses the farm, then require the farm to move it because, after all, birds might sit on the telephone wire and do their business.

First these actions are taken without scientific support. Has the FDA passed a regulation against birds doing their business while flying or standing in the field? Where is the peer-reviewed study demonstrating that telephone wires increase the risk of salmonella contamination on a farm?

Second, FDA applies this requirement only to the particular farm under investigation. But they don’t issue a pronouncement that they have studied the matter and that telephone and electric wires must be removed from all farms or all tomato farms or produce farms. In fact, the farm next door to the one being investigated will not be required to move the wires.

Everyone would like to have FDA find the source, but mostly that is just so that everyone else can say they were not implicated.

We wish the FDA luck; we think traceback will be difficult but even more unlikely is actually learning anything useful if we ever do find the farm.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

FDA Shakedown

It is no surprise, but in a recent conference call Dr. David Acheson, M.D., FDA’s Associate Commissioner for Foods, finally fessed up to the way FDA’s “not implicated” list is set up.

Being that life offers only two possibilities, either one is “implicated” or one is “not implicated,” a consumer is likely to think that a place NOT included on the “not implicated” list is, in fact, “implicated,” Dr. Acheson went to great pains, in a press conference, to explain that this is not so.

In fact, in Dr. Acheson’s words, the list consists solely of states or regions that have “come to us” and made a case for exclusion.

One wonders if Dr. Acheson is aware of how horribly inept this is. Every time that list changes, it causes consumer confusion. It also typically means a failure has already occurred that cost somebody money.

We ran a piece in which it was detailed how Subway’s supplier had to put its Hawaiian restaurants, which purchase Hawaiian grown tomatoes, under a ban for ten hours until FDA added Hawaii to the “safe” list. But there was never the slightest possibility that Hawaiian tomatoes were implicated.

Now, FDA has announced that Oklahoma tomatoes are also not implicated.

Each time the list is changed, it is a news story and causes consumers to be newly concerned about tomato consumption.

Besides, why should some farmer or hot house grower’s livelihood depend on his ability to persuade his state department of agriculture to take up his cause in DC?

Basically it is a recipe for a shakedown. Farmers go hat-in-hand to state legislators asking for help, and those legislators turn to the farmers with palms outstretched looking for campaign donations.

The industry would do the work for free and put together a great list of the very few areas that could be implicated in this outbreak. Everyplace else belongs on the “not implicated” list, and the FDA should be ashamed to publish a list that inherently and falsely implies that other areas are under suspicion.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

CDC’s Map Of Ill PersonsCould Use Some Improvement

The other day, we did a piece entitled, Some Advice For CDC And FDA. In the article we basically raised two points. First, that FDA and CDC need to examine their use of language. The constant announcement of “new” or “additional” cases is deceptive because consumers interpret that to mean somebody got sick today when, in fact, the “new” cases can be a month old and they are “new” only in the sense that the CDC didn’t know about them before.

We actually think FDA and CDC did much better on this issue in the last two press conferences. They clearly tried to emphasize that these were mostly old cases. So kudos to them for trying to do a better job.

We also critiqued the CDC map:

The problem with this map is that, like an Election Day map on TV, it is one of two colors — in this case, white or green.

For Election Day, this makes sense since the state is either Democratic or Republican.

But for a map of illness, this model — on or off, white or green — makes no sense. If you look at this map, it looks like a broadly dispersed problem. However, if you study the numbers, you see how deceptive that is.

New York may be green — but only with two people ill. Vermont, just one; Connecticut, only two; Florida, only one, etc. By way of contrast, Texas and New Mexico have 68 each!

We are not there yet, but we thought we could try a few pictorial alternatives. Here is the CDC Map and caption:

Since April, 383 persons infected with Salmonella Saintpaul with the same genetic fingerprint have been identified in 30 states and the District of Columbia. These were identified because clinical laboratories in all states send Salmonella strains from ill persons to their State public health laboratory for characterization. The marked increase in reported ill persons is not primarily due to a large number of new infections. The number of reported ill persons increased markedly mainly because some states improved surveillance for Salmonella in response to this outbreak and because laboratory identification of many previously submitted strains was completed. The number of ill persons identified in each state is as follows: Arkansas (2 persons), Arizona (26), California (8), Colorado (2), Connecticut (2), Florida (1), Georgia (8), Idaho (3), Illinois (34), Indiana (8), Kansas (9), Kentucky (1), Maryland (10), Michigan (3), Missouri (9), New Hampshire (1), New Mexico (70), New York (9), North Carolina (1), Ohio (3), Oklahoma (5), Oregon (4), Pennsylvania (2), Tennessee (4), Texas (131), Utah (2), Virginia (17), Vermont (1), Washington (1), Wisconsin (5), and the District of Columbia (1).

Now here are some alternative map concepts we have been working with:

Our first thought was to use pins to represent each illness. CDC hasn’t told us the counties, so we just stuck the pins in the map in the state where the illness occurred. With more information, the map could show more detailed information. In other words, if all the illnesses in Illinois are limited to Chicago, that is a very different outbreak than one with illnesses spread throughout the state.

The map definitely has some advantages over the CDC one. A state such as Florida shows up bright green, just like Texas on the CDC map. Here you instantly see that there was one isolated Floridian who got sick from eating tomatoes — implying he or she was probably a tourist who visited the outbreak area.

On the other hand, we still aren’t thrilled because the map is still deceptive. A state like Texas looks like it is covered in victims from wall to wall — but, in actuality, the 131 pins could fit easily in one neighborhood or apartment building.

There is also no sense of proportionality between state population and the outbreak. New Mexico, with a small population, is hit much harder than Texas on a proportional basis, even though Texas has more victims.

This is much more accurate but isn’t very graphically appealing.

This gives some good information graphically, but you really don’t want to have to look at a legend to understand the map.

This is basically the CDC’s map with the states color-coded to match cohorts of the outbreak. It is not perfect. Like the CDC, you have to look at the legend to know what it means, but it does give a lot more information at a glance than the CDC map.

We’ll keep working on developing options… if anyone has some ideas for a map that is accurate, information-rich and won’t cause panic when none is required, we welcome ideas here.

Many thanks to Matt Winans for help with the graphics.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

FDA Provides No IncentiveTo Invest In Food Safety

One wonders if the FDA is aware of how much its rhetoric has diverged from its practice. On a recent press call, Dr. David Acheson, M.D., FDA’s Associate Commissioner for Foods, said all the right things about food safety. When he was asked if the FDA was going to do more inspections, he said that although FDA would be adding inspectors, you can’t inspect safety into fresh produce at the end.

The key, he correctly stated, was to “build prevention and safety up-front.” In other words, you can’t see pathogens, so mere visual inspection won’t help very much. You can test, but it is expensive, takes time and we are unlikely to be able to test enough product to statistically guarantee safety. That is why farmers in implicated areas can’t just test a load and then send it over with a certificate.

So the only option is a system to ensure that during the entire lifecycle of the product, it is always treated in accordance with best practices — that is, building prevention and safety up front.

Yet… and here is the rub: Despite saying this and seeming to recognize its importance, the FDA has made NO ALLOWANCE for firms that have done this. In fact, the FDA treats the most negligent farmer in a region EXACTLY THE SAME as the most progressive and safety-conscious.

Although FDA has a mechanism for whole states or regions to prove they were not in production or marketing at the time of the outbreak so that they can be added to the “not implicated” list, it has no mechanism to provide relief for a farm that made the effort to do what Dr. Acheson wanted it to do: Build prevention and safety up front.

Show at FDA’s door with a raft of Primus and Davis certifications? It doesn’t help. Perhaps you are certified under Tesco’s Nature’s Choice scheme or Marks & Spencer’s Field-to-Fork program? No difference. McDonald’s, Darden, Denny’s, Jack-in-the-Box, Sysco, all trust you? Unimportant to the FDA.

All in all, each time there is an outbreak on fresh produce FDA is damaging public health by micro-focusing on the one known outbreak as if it is the only food safety risk in the world.

In the short term, bans on complete regions lead buyers to purchase produce from strangers. In other words, carefully vetted companies get tossed aside and their produce is replaced by the production of far less vetted farms and companies.

So because less prevention and safety was built in up front — because the FDA compelled the buyer to drop its supplier with whom it worked to build in prevention and safety — the risk to consumers actually is increased due to FDA’s actions, not decreased.

Want to know what would have made a big difference in future food safety expenditures and thus, long-term, in food safety? If FDA had announced that while it searches for a source, it is going to block imports except from those farms that are third-party audited to conform to Good Agricultural Practices, then FDA would be sending a message that it pays to invest in food safety. Now FDA just sends this message: Don’t listen to what we say, watch what we do and we will treat the most safety-conscious grower precisely the same as the most negligent grower.

There is no upside from the FDA in any individual farm investing in food safety.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

Habeas lycopersicum — Tomatoes Falsely ‘Imprisoned’

We’ve run a series of pieces detailing the struggle of Mexican tomato growers to get the same treatment Florida has… an “exemption” for those parts of the country that were not in production at the time of the outbreak.

With pieces, such as Free Baja, Andrew & Williamson Hit Hard By FDA’s Mexican Tomato Ban, FPAA Trying To Clear Baja, Baja Growers Denied Fair Access…Building Case For WTO plus FDA Leaves Mexico in the Dark, we’ve explored the impact of FDA’s policy in this matter.

Most recently, we ran a letter from Marco Jimenez, President of Divine Ripe, LLC in a piece we entitled, Mexican Tomato Grower Says Illinois Embargoed Its Product.

In the piece, Mr. Jimenez points out that his operations — and many others in Mexico — should be on the “not implicated” list based on the date of production onset. Also that Illinois has turned an FDA recommendation on its head and given it the force of law. But the recommendation has not gone through the vetting that a law or even a regulation would have to.

We wanted to know more about this operation. Marco Jimenez was traveling so Pundit Investigator and Special Projects Editor Mira Slott spoke with an associate:

Albert Cantu
sales
Divine Ripe
Hidalgo, Texas

Q: What production areas in Mexico are you involved in? Did you receive any relief when FDA cleared Baja California North?

A: Our production comes more from the center part of Mexico, northeast of Sinaloa, south of Del Rio, Texas; four or five hours directly south, and that’s where our growing areas are located.

We’re in the same situation as Baja California; we just started production in those areas, two growers began two-and-a-half weeks ago, the other one three-and-a-half weeks ago. Everything is hothouse, hydroponic products.

Q: Could you clarify what you mean by hothouse and hydroponics? Are the products all grown in greenhouses?

A. To us, we distinguish between a shade house, a greenhouse and a hothouse. The shade house can be a mesh-type screen where water, wind and heat still penetrate to some extent. A greenhouse, by our definition, is a combination of screens and plastic. Maybe the roof is plastic, water can penetrate, but walls are screens.

A hothouse is hard wall with hard plastic. Sometimes it’s shaded depending on how much sun you want coming in. Some roofs, like ours, can open for sunlight and then can close if you want controlled sunlight. This is a mechanical motorized system. Hothouse is completely hard plastic, where you control the temperature. It’s more of a high tech environment than a regular growing field. We only have hothouses; everything is hydroponically grown. .

Q: Is there a medium, such as chips, that the roots are grown in to support the life of the plant?

A: Our growers use individual soil bags. In case something goes wrong with one plant, they pull that one and don’t bother the rest of them.

Q: Where are you getting your water?

A: Our water source is deep well irrigation, 200 feet deep. This is not canal irrigation. The FDA did scare all the people. In every sense, we’ve been trying to figure out what to do since the outbreak.

FDA doesn’t have money invested in this like we do. It appears that they don’t care. This is very hard for these farmers. This is their livelihood. It’s like FDA doesn’t even know we exist. Those that are most aggressive get on the approved list. It appears to be political. If we don’t fight, we don’t get anything. We had no where to turn and hope that you can help us. This is why we wrote to Mr. Prevor.

Q: What has your experience been up to this point?

A: We were distributing tomatoes 10 days ago, four loads of tomatoes into Chicago. The Illinois Department of Health rejected the loads and kicked them out from the state and sent them back to us. They read on the FDA page that Mexico was not on the safe list. The loads left on June 7, the loads were rejected on June 9, and returned on June 13.

Q: What does that cost you?

A: You are looking at $100,000 in expense right there. We had to pay freight going to Chicago, and FDA released the publication not to eat Mexican tomatoes. Our receiver had orders canceled and couldn’t receive product, and no one to buy in Chicago.

We are distributing our tomatoes in Mexico, bringing in 5 to 8 loads at a time. We are still selling tomatoes because we know they have no problems. It’s very hard to convince people. We hired a private lab to analyze tomatoes for Salmonella. We’re in the process of getting our warehouse inspected for Salmonella as well to see if this will ease the discomfort from the public.

Q: What are the production schedules for your growing areas?

A: All of our tomato production started after the outbreak. Our production began the last part of May, first part of June, 30 days after the first onset of illness. We still have fields that we haven’t even started harvesting coming on the next week or so. We haven’t starting picking. They’re new crops. Everything is hot house, hydroponic, high-quality tomatoes.

Q: Have you relayed this information to the FDA or other U.S. government channels?

A: The FDA, along with a lot of other people, don’t understand. They concentrate on several major points: Jalisco, Sinaloa, and Baja. The public and FDA know those three places. We have hothouses in Chihuahua and Durango, and some in San Luis. These states also did not start production until after the onset of the outbreak time period.

Q What do you think is the reason FDA hasn’t put these areas on the approved list?

A: We have no idea why not. Maybe FDA doesn’t know about these areas. We thought if we write a letter to Mr. Prevor and he writes about us, maybe FDA will come to know about our areas.

There are not that many tomatoes grown out of that area. The biggest are us. We have the most ground cover. Unless we speak up, we’re the little mouse, and the giant is going to walk across and step on us. We hear “Baja” but no one cares about us. These are people who have been growers for a long time and we are fortunate to start working with them two or three years ago.

Q: Will you have any trouble fulfilling the certification requirements FDA has put in place for Baja California North?

A: It won’t be a problem with all these certificates. We just need to be treated in the same way.

This Pundit’s heart breaks at the lives ruined, fortunes lost, food destroyed and all, for what? What is FDA’s estimate of the chance that a tomato shipped tomorrow from the non-approved areas of Mexico will have Salmonella? And what is FDA’s estimate of the chances that a tomato shipped tomorrow from an approved area will have Salmonella?

The FDA won’t say, and the reason it won’t say is because it would be embarrassed. There would be no difference.

It would suddenly be clear, as we mentioned in this letter from Al Siger that the Emperor Has No Clothes. There is simply no basis for what the FDA is doing.

Read these plaintitive lines:

FDA doesn’t have money invested in this like we do. It appears that they don’t care. This is very hard for these farmers. This is their livelihood. It’s like FDA doesn’t even know we exist. Those that are most aggressive get on the approved list. It appears to be political. If we don’t fight, we don’t get anything. We had no where to turn and hope that you can help us. This is why we wrote to Mr. Prevor.

We don’t know if we can help. We have no authority, but we sure have a Bully Pulpit, and we are pleased to use it in such a righteous cause.

For this goes well beyond food safety. It simply stinks. The FDA exempts north Florida because it has two senators and 25 representatives who vote on FDA appropriations and who can call FDA officials to testify and make their lives miserable.

It releases northern Baja, but just as the attorneys we interviewed indicated, FDA often allows some small portion of a country’s production in so that the foreign government, in this case Mexico, can’t so easily bring a WTO complaint. But in the end, FDA exercises the kind of discretion incompatible with democracy and the rule of law.

This is bad because long after the tomatoes are flowing freely, people around the world will think of our democracy as Mr. Cantu does:

Those that are most aggressive get on the approved list. It appears to be political. If we don’t fight, we don’t get anything.

In writing the Constitution of Massachusetts in 1780, John Adams incorporated the phrase, “A government of laws, not of men” into the document and so enshrined a quintessential American concept — that our leaders are not kings and your treatment will not be determined by the favor the king may hold you in.

In adopting a rudderless standard, wholly dependent on the whims of FDA officials, completely requiring one to appear as a supplicant before the FDA begging for a dispensation, the leaders of this agency may cost us far more than a mishandled food safety outbreak. They put at risk our faith in our government to do right and the esteem the world might hold us in.

The loss is incalculable and all for nothing.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

More Than One Outbreak?

As one looks at the numbers, one wonders if this is actually a single outbreak.

Right from the beginning, there was something curious about this distribution of cases. New Mexico early on named names, saying that:

Individuals and restaurants that bought tomatoes from Walmart in Las Cruces or Farmington, Lowe’s in Las Cruces, or Bashas’ in Crownpoint since May 3 should not eat them uncooked.

This was peculiar to us as such chains typically buy through distribution centers, and so we would expect other stores serviced by the DC to have identical product and also have sick people.

At the same time, if, say, Wal-Mart’s DC had bought tomatoes that had this pathogen, it would be a strange coincidence if Lowe’s and Basha’s had also bought from the same farm.

This led us to think, as we said at the time that this might be a case of store managers buying outside their procurement systems.

For a local New Mexico outbreak with four stores in or near Las Cruces implicated, it made perfect sense.

One farmer with tomatoes, selling directly to each of four local stores explains how they would all have the same problem but the other stores serviced by the chain’s distribution center would not.

Now, of course, with the outbreak expanded with sick people in 30 states, our one-farmer theory seems unlikely.

Now we don’t know enough to deduce simply from the map and the numbers. We sometimes think that someone at CDC wants to write a great academic paper, and so they keep information bottled up. After all, if they really wanted to solve this as quickly as possible, they would tap into the collective wisdom of the population by publishing on the Internet all non-confidential information.

What days did people actually report the onset of illness? Are the 27 people in Virginia and Maryland individual local cases or did the Smith family have a reunion in Las Cruces, NM, and they returned home sick?

If the government would make this kind of information available, very smart people all over the world would help it figure out the case — and they would do it for free.

In any case, on a press call there was a reference made by the government to two “bumps” during the course of this outbreak. We look at the distribution of cases and it is easily possible to imagine separate events in the southwest, in the Midwest and, maybe, in the DC metro area.p>

It might even be product of two regions. What if the Southwest and Midwest got Mexican product but Florida sent product to DC metro?

Now, of course, this is classified as one outbreak because it all shares the same genetic fingerprint. But that is an unfortunate term, bringing to mind the distinctiveness of human fingerprints.

That is not how it works. A flock of migratory birds could do its business and leave behind a distinctive “fingerprint,” and then fly somewhere else and do it again.

We don’t have the information to know but, presumably, the reason the traceback hasn’t yet succeeded is that FDA can’t find a common source. The FDA long ago had purchasing records from Wal-Mart, Lowe’s and Basha’s, and New Mexico is very certain they found the retailer where sick people bought tomatoes. Even without “solving” the outbreak for everywhere, that is a lot to go on. And it is the kind of data that should be relatively easily traceable.

If, however this outbreak spreads over several farms, say because they were all drawing on the same irrigation water source, or the same flock of birds visited several farms, then there won’t be a common source.

But why would the FDA by this time not have visited all the farms that the Wal-Mart, Basha’s and Lowe’s traceback led them to?

Curiouser and curiouser.




SPECIAL EDITION VI
Salmonella/Tomato Outbreak Info
From FDA Becomes More Bizarre

You May Never Look At Spin The Bottle The Same Way Again

A hat tip to Dan Cohen of Maccabee Seed Co. for sending along a USA Today article by Elizabeth Weise that we think is a fascinating piece regarding the early days of the current Salmonella Saintpaul Tomato outbreak. The piece is entitled, How Modern Science and Old-Fashioned Detective Work Cracked the Salmonella Case:

…health officials say that because the first cluster of patients surfaced on the Navajo Nation in New Mexico, where they are served by a small, close-knit medical community, federal investigators were able to quickly identify the contaminated foods and take steps to contain the outbreak the past two weeks.

After being the first to recognize the signs of an emerging outbreak, the federal Indian Health Service staff played a key role in the search for the tainted food. “It was 21st-century molecular epidemiology and old-fashioned boot leather,” says John Redd, the infectious disease branch chief with the Indian Health Service in Albuquerque. “You’ve got to get out from behind your desk and hit the road sometimes.”

Kimberlae Houk has 24 years of experience in public health nursing in the Navajo Nation, the largest reservation in the USA, with lands extending into Arizona, Utah and New Mexico.

Her Shiprock Indian Health Services Unit provides medical care to more than 45,500 American Indians, mostly Navajo, in an area that covers 23 communities in the three states. Homes can be extremely isolated, and many are without telephones.

Houk knew something was up on Monday, May 19, when four people very sick with diarrhea, fever and abdominal cramps showed up at the Northern Navajo Medical Center in Shiprock, N.M.

“A lot of time with these kinds of diseases you get your babies and your grandmas in the hospital,” she says. “But in this one we had fit 30-year-olds. And we just don’t get 30-year-olds in the hospital with dehydration.”

And these people weren’t just dropping in at the doctor’s office. “We serve a very rural population. They have to drive an hour to the clinic and an hour back. So it’s a big deal to come in,” Houk says.

With previous experience with outbreaks of measles, whooping cough, hantavirus and even the plague, Houk immediately went into outbreak mode. “We literally drop everything when there’s a communicable disease, to protect people.”

That day, “We all just ran,” says Houk. “We can really get on top of things quickly because all our nurses, our doctors, our clinics, our labs, we’re all under the same roof.”

…Then New Mexico posted the genetic fingerprints of its cases onto PulseNet, the CDC’s computer disease-tracking network. Within hours, matches began to show up. The outbreak wasn’t just in New Mexico and Texas, it was all over the country.

Now came the challenge: What connected a patient on remote Navajo lands with the other patients throughout the nation?

Even though it was Memorial Day weekend, everyone mobilized to work. New Mexico, Texas, the CDC and the Indian Health Service began holding daily conference calls. As other states got patients, they joined in. New Mexico started the calls, but eventually CDC took over hosting them because they “can accommodate 100 people on their lines,” Houk says.

In a case like this, epidemiologists, the doctors who study outbreaks, pull out what they call a “shotgun survey.” It’s a long — in this case 22 pages — survey that covers just about anything a person might eat, drink or be exposed to that could cause such an illness.

“Shotgun, because it’s like shooting in the dark to see what’s there,” says Texas’ Gaul.

Enter the Indian Health Service again, charged with the task of administering the survey in the Navajo Nation, which by sheer chance seemed to have gotten the most cases in New Mexico.

“Our Indian Health nurses would drive two or three hours to try to find these people and when they couldn’t find them, they’d have to go back,” he says.

Also, each nurse had to painstakingly reconstruct everything their patient had eaten in the previous two weeks. “Nurses pulled out calendars for clients and said, ‘Where were you? Who were you with? What meal did you have with that event? What did you do before the event, and what did you eat later in the day?’” says Houk.

Not only that, but the surveys had to be given in three languages: English, Spanish and “English with Navajo clarification,” Redd says.

“The folks in New Mexico really did an amazing job,” says CDC’s Williams. “Extraordinary.”

By Saturday more than a dozen of these questionnaires were completed. Epidemiologists and public health workers pored over them, looking for patterns. Jessica Jungk, a master of public health who also helped track spinach in the 2006 E. coli outbreak, got called in to help analyze the data. But while tomatoes were high on the list of foods eaten, they weren’t a strong enough presence to be isolated as the problem.

Ettestad got on the phone with CDC’s Williams, who urged really zeroing in on what people were eating. “Get them to open their refrigerators, their pantries” while they talk, he suggested.

To do that, a nurse was sent into a patient’s home “and she literally pointed at every shelf on the refrigerator and every cabinet and asked, ‘Did you eat anything on this shelf?’ It’s a difficult thing to do. It makes people feel anxious,” Houk says.

But it did the trick. Even people who swear they didn’t eat raw tomatoes remember they might have when asked about salsa or guacamole or a slice of tomato on a hamburger. On Saturday, with surveys coming in not only from New Mexico but a few other states as well, the percentage of patients who’d eaten fresh tomatoes stood at 75%, compared with an average of 68% random Americans. By Sunday, with more cases analyzed, the share shot up to 83%, Ettestad says.

But that wasn’t enough to nail tomato as the culprit. Next came the scientific gold standard, a case control survey to look at whether people who didn’t get sick ate significantly less of the suspect food than people who did. For this, the investigators employed a tried and true tool for random selection: spin-the-bottle.

The key to a good case control is randomness. Investigators want to compare healthy people with those who got sick, but they want them to be similar in every other way, and they don’t want to bias who gets chosen. Today epidemiologists use computerized phone books and an Internet randomizing program.

But a lot of the people they needed to talk to didn’t even have phones.

So they want back to the old techniques. “You go out to the house of someone who got sick. You take a bottle and put it on the ground. You spin it and you go in the direction it points until you hit a house,” Ettestad says. “And that’s just as random as the Internet.”

Redd of the Indian Health Service didn’t even have a bottle: “I was spinning a government-issue pen.”

By Saturday, May 31, New Mexico was ready to start warning people. We felt we had enough evidence and we needed to protect our citizens,” Ettestad says….

Dan has been kind enough to share ideas with us here and here, and after the spinach crisis, he wrote for the Community Alliance with Family Farmers an intriguing proposal entitled, “The History, Politics & Perils Of The Current Food Safety Controversy” CAFF Guide to Proposed Food Safety Regulation.

It is a very interesting piece and, although much is controversial, Part II, entitled “A New Pathogen” (page 14) deals with E. coli 0157:H7 and discusses some of the same case/control and epidemiology issues that the USA Today piece deals with in relationship to the Salmonella Saintpaul outbreak.

What we find intriguing about this USA Today piece is that it demonstrates how, even in our high-tech times, much depends on individual motivation.

This case wasn’t discovered by a computer; the truth was wrestled from the ill by a highly dedicated group of health care workers. Really extraordinary work.

Many thanks to Dan for bringing it to our attention.

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