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FDA’s Sacrificial Lambs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dear Dr. Acheson:

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

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

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

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

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

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

Reginald L. Brown
Executive Vice President
Florida Tomato Growers Exchange

cc: Florida Congressional Delegation
FTGE Board of Directors

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

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

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

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