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Does FDA Put Its Reputation
Above Enhanced Food Safety?

Why has the FDA chosen to act in the manner it has regarding the pistachio industry? Gardiner Harris and Andrew Martin of The New York Times explain the matter this way:

“The food industry needs to be on notice that F.D.A. is going to be much more proactive and move things far faster,” said Dr. David Acheson, associate commissioner for foods at the Food and Drug Administration. “We’re going to try to stop people from getting sick in the first place, as opposed to waiting until we have illness and death before we take action.”

They also point to new management:

Agency officials said in interviews that Dr. Joshua Sharfstein — the administration’s choice to lead the agency while Dr. Margaret Hamburg goes through the confirmation process to become commissioner — sought to avoid the agency’s cautious, step-by-step actions in the recent peanut recall. More than a month passed between the initial recall of a few lots of peanut butter and a decision to recall years of production from the Georgia and Texas plants of the Peanut Corporation of America.

Agency officials have long been reluctant to seek broad food recalls unless contamination has been proved, and such gradually expanding recalls have been a common feature of F.D.A. food actions for decades. Last week, Dr. Sharfstein told agency officials to act boldly far earlier, officials said.

Dr. Sharfstein speeded the agency’s decision making by getting as many as 40 agency officials to talk to one another in weekend conference calls. Dr. Sharfstein “wanted to drive it hard and drive it fast,” Dr. Acheson said.

So the question that should be fairly asked is a simple one: Has the FDA’s aggressive action increased food safety? The answer is that this is unlikely. The powers that be at FDA are either well intentioned but incorrect in their analysis, or they are more concerned with burnishing FDA’s reputation for enhancing food safety than with actually enhancing food safety.

Here is the problem. The particular firm implicated in this food safety investigation has a good reputation. We quickly get calls when things like this break, from ex-employees, competitors, etc., telling us if the management of a company is sleazy. That is why if you check out past editions of the Pundit you will find no pieces defending the management of Peanut Corporation of America — we heard from too many people of too many problematic decisions.

We are not getting that feedback on this firm.

Now what about the FDA’s alleged finding of salmonella in the plant in California… doesn’t that, you may ask, prove that the FDA acted prudently and, in fact, enhanced food safety by getting this product out of the system? Especially since the FDA simultaneously identified some imperfect production practices?

No it does not. In order to enhance food safety, the FDA would have to know that the product from this one plant is more likely to have pathogens on it than the average product being turned out by alternative sources.

Yet the methodology the FDA is using is simply not designed to prove anything like that.

In this case, the FDA dove in to the implicated plant, did hundreds of tests, a super thorough evaluation and found some things that were problematic.

We have absolutely no issue with its efforts and, indeed, think the plant should correct them and produce safer food. We have no indication — from the FDA or anyone else — that the company is unwilling to do so.

But if we did hundreds of tests and super-thorough inspections of all other pistachio facilities, how do we know all of them would be flawless in design and execution and without a pathogen to be found? And if we don’t know that, then how can we possibly know whether we are helping or hurting food safety?

If the implicated plant is imperfect but less imperfect than its competitors, then restricting its sales but not those of its competitors simply makes the food supply more dangerous — not safer.

It is the failure of FDA to present rational arguments for its actions or to even indicate its awareness of these dilemmas that make us feel its executives are more concerned with enhancing the institutional reputation of FDA than they are with enhancing food safety.

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