Special Edition X —
Salmonella Saintpaul Outbreak…
FDA’s Contempt For Industry
Causes Pain And Suffering
Energy And Commerce Committee
Should Think About Commerce
In Hearings On ‘Broken’ FDA
Jim Prevor’s Perishable Pundit, July 10, 2008
In a little ironic twist, it is the Committee on Energy and Commerce — chaired by Representative John D. Dingell (D-MI) — and, specifically, its Subcommittee on Oversight and Investigations — chaired by Bart Stupak (D-MI) — that soon will hold hearings related to the Salmonella Saintpaul outbreak. The hearings will be “…examining the inability of the Food and Drug Administration (FDA) to identify the cause of the recent national outbreak of salmonella.”
The position of the Democratic majority on the Committee is well articulated: “Until FDA has the leadership and resources necessary to keep bad food off our grocery shelves and dining room tables, Americans will continue to be concerned that the food they eat may not always be safe… If it hasn’t been made abundantly clear through our eight previous food safety hearings, this salmonella outbreak should leave no one doubting that the FDA is broken. We need a modern FDA equipped with not just the financial resources but also the regulatory tools to adequately prevent and respond to future outbreaks.”
Although we agree that more resources will be necessary to have a world-class CDC and FDA and, even more so, to bring our state labs up to snuff and, by definition, better leadership is better, we confess that we have some trepidations about simply pouring money into the same structure.
We believe the current inspection regimen on the Mexican/US border is an excellent example of how FDA needlessly cripples commerce in America… a matter one would think would be of some interest to the members of the Committee on Energy and Commerce.
Here is a situation in which the FDA, by its own acknowledgement, is searching for the cause of which it only has a few hunches. So, unlike cases where a certain product is implicated after interviewing sick people and FDA searches for that particular product at a farm as probable cause, none of the farmers of any category of product is believed to be a suspect of this problem.
In fact, if the FDA is sampling cilantro, jalapeno pepper, Serrano pepper, basil, scallions and tomatoes for this rare strain of Salmonella, this means that either five of the six products are NOT implicated or they are all grown together on some bio-diverse farm. In either case, well over 99% of the farmers shipping these products are completely uninvolved in the outbreak. So this type of sampling is best viewed as a kind of research project.
So the Committee on Energy and Commerce ought to ask FDA why is it necessary to hold these products when more than 99% of the tested items will come back negative? Without a doubt, if the FDA wants to extract tribute from the produce industry by stealing a few items for testing from every van, the industry would gladly contribute.
In fact, if the FDA continues such a sampling program indefinitely, it might be doing the industry a favor by elucidating the baseline occurrence of various pathogens so we would understand what would constitute progress in reducing the level of pathogens.
The key, though, is that for literally no reason, FDA is disrupting the flow of commerce by not allowing any of these products to be sold. Understand that not only is 99-plus percent of the product from farms that have nothing to do with this outbreak — even if it is a farm-based outbreak — but, also, the sample size is too small to assure safety even if there is Salmonella Saintpaul on the actual van being tested. FDA would need to perform a Monte Carlo simulation to ascertain the sampling necessary to gain a statistical assurance of an absence of Salmonella in the trailer.
And since we are only testing for Salmonella, even this methodology will provide zero protection against any other pathogen, incorrect pesticide application or any other risk.
If FDA decides to release all the product for sale, it will still have the name of the farm, etc., that shipped the product. Some additional product may enter the food supply, but FDA can recall the product instantly and go back to the farm at once.
The price we pay is some contaminated product might slip through, but statistically, the odds are little different than if they just randomly stopped vans of produce.
So why is the FDA doing this? Here are three possible answers:
1) Habit — this is the way the FDA does sampling and so set in its ways are the leaders that they just didn’t think of doing it another way.
2) Statistical ignorance — the FDA doesn’t understand the math and actually thinks it is doing something to enhance public health by stopping the sale of these shipments.
3) Self Preservation as a Priority — What the FDA is worried about is not public health — stopping these vans is statistically going to give you a number indistinguishable from just randomly stopping vans of produce — but self-preservation. If people get sick from something that FDA didn’t know about — it is off the hook. But if the FDA had actually had a van in its possession that later tests positive, it would be attacked for putting public health at risk and FDA officials simply don’t want that burden.
Still, a member of the United States House of Representatives serving on the Committee on Energy and Commerce should have a more-than-passing interest in making sure that public health operates in a manner that does not unnecessarily burden commerce.
After all, safe food is unlikely to be produced by a bunch of bankrupt farmers. And consumers, while wanting safe food, also want economic prosperity.
What the Representatives on the committee have is the virtually unique power to compel FDA to answer questions. So we hope a Representative will ask the FDA how it calculated the cost and benefits of restricting the sale of all these products until the test results came back. We hope a Representative will further ask to see the comparative study done on the cost and benefits of letting the products be sold from the vans from which tested product was drawn.
Although we doubt FDA has done any of these cost-and-benefit analyses, the question will reveal the casual and lackadaisical kind of thinking that seems to inform decision-making at the FDA.