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FDA ‘Spokesperson’ Justifies
Reasoning Behind Pistachio Recall

We wanted to get an update and clarification from the FDA itself on the state of the Setton Pistachio recall, so we asked Pundit Investigator and Special Projects Editor Mira Slott to find out more.

We run her conversation below, but the FDA now has a policy that all its people should be anonymous and go by the term “spokesperson” so even though we know who we spoke to we are told not to identify the person by name.

This is almost precisely the opposite of the transparency and accountability President Obama promised in his campaign so we hope the new regime at FDA will change this ridiculous policy quickly. Spokespeople should always be identified by names so they can be evaluated for the honesty and accuracy and completeness of their communication:

FDA Spokesperson:

Q: FDA said it found salmonella in the Setton plant and problems in processing that could cause cross contamination of raw and roasted nuts. If FDA went to other plants and did comprehensive studies, could it find problems such as this? How unusual is this discovery? Do you have any baseline for comparison?

A: Hopefully, you wouldn’t find salmonella in an area you wouldn’t expect to — in certain points in the production line. The key thing is that we sent a letter on April 3 to pistachio processors about current good manufacturing practices. FDA basically reminded processors of their legal responsibility to insure products are safe for consumption and walked through a number of pertinent things mentioned in the good manufacturing practices. FDA wants to work with the industry to help understand the risks, to examine current pistachio practices that could lead to contamination with bacteria and measures to prevent contamination.

Q: But that still doesn’t answer the question. Setton has an excellent reputation for high food safety standards and has been regularly audited by respected third-party auditors and retailers. How does FDA reconcile the fact that these same problems it points to at Setton could be just as prevalent in other facilities? Without a baseline, how does FDA justify its sweeping recall action?

A: FDA is still doing its investigation. I can’t directly address that. We need to finish the investigation to get an idea of the complete circumstances while these products were being processed. It is also possible the firm is very attentive to many things but may have missed something.

We hope to learn what went awry so it won’t occur again. There is not necessarily a sense that anyone was intentionally doing something wrong. There are just times when something is going on that people miss. Our focus is on what exactly went wrong. This speaks to what I just mentioned. FDA wants to look at current practices that could lead to bacteria and provide additional guidance of measures that can be taken.

If we take a closer look, maybe there is additional information that could reduce the likelihood even further that pistachios could be the cause of a foodborne outbreak.

Q: But this recall was not related to an outbreak, was it?

A: You’re right. This is not an outbreak because illnesses are not associated at this point. People reported illnesses that could be related, but we don’t have a confirmed link to illness and product. There are two things that would trigger a recall. Why would we notify people not to eat a product? Certainly if people start getting sick from a product. Sometimes people take action due to a test showing a positive result for a pathogen. No one has gotten sick, but someone could.

In the case of the pistachio recall, Kraft did tests and got salmonella results that went back to Setton Farms. The fact there are no illnesses certainly doesn’t mean there isn’t a potential problem.

Q: Actually, there’s quite a bit of confusion regarding the testing and the time line involved. Could you clarify who did testing, when, where, in what products, and what results were found at different time periods? For example, were all four salmonella serotypes discovered in Setton Pistachio product simultaneously in March at the Georgia Nut Company’s facility? Was the determination that the problem was in pistachios from Setton Farms deduced as the common link from various tests done over an 18-month period? If testing was done over an extended period, I presume there were many negatives. Could this indicate sporadic infection?

A: There were four strains that came up, and I’m quite sure all were from March. Some testing I understood to be in a Kraft trail mix product that turned out positive for several ingredients. I can’t speak to the detailed time line of testing, but the bottom line is that somewhere along the line there’s been some kind of processing breakdown at Setton, and we can all be certain of that. Salmonella in raw product is supposed to be eliminated in the roasting kill step.

Q: In Setton Pistachio’s expanded recall release, it says, ‘Setton’s raw in-shell pistachio shipments are NOT affected by this recall expansion.’ Why is that? Couldn’t the raw product be a likely source of the salmonella?

A: Raw agriculture product may have some contamination. If this product is roasted, I don’t know if it’s a moot point.

For Setton Pistachio, it moved to expand its recall to all products harvested in 2008, let me reword that, to all roasted in-shell and shelled and raw shelled pistachios not subsequently roasted prior to retail sales. If I were selling you raw pistachios, but the expectation was that you were going to roast them, you would have that kill step in there, providing you roasted them at the right temperature, etc.

Even if you go with the presumption the raw pistachios are not salmonella-free, they’re going to be roasted. If you were going to sell pistachios to consumers raw, it wouldn’t make sense to ship them. Setton did ship raw product to certain people, but if they weren’t roasting it, the product has to come back.

Suppose you’re Setton Farms or another pistachio processor and you have some product coming in from the field. A bird could have contaminated it. You move it through the facility and it goes down some processing line where it gets roasted. If the roasting process is adequate, you have a kill step and there should be no salmonella. It’s possible, but our assumption is that if some is contaminated, you’re decontaminating it as a kill step. Shipping that raw product someplace else, you’re passing it through to the next company where someone else is roasting it and killing any contamination.

Q: Isn’t there some risk that contamination or cross-contamination could occur from the time it’s shipped until the time it’s roasted at the other company?

A: Yes, that’s a valid point. How is it shipped out from Setton? My understanding is that things got shipped in 1,000-pound and 2,000-pound containers. I imagine that raw in-shell product that is not part of the expanded recall is shipped like everything else.

Like anything, if the raw product is contaminated, anything it touches along the way could be cross-contaminated. One thing that gets confusing is that people might have in mind that things coming from the field are sterile but they aren’t.

Q: Dr. Acheson says salmonella was found in “critical areas” of the Setton facility. Can you define those areas specifically? Where was the salmonella found exactly? And how many samples came back positive? Have you connected the serotypes to the positive results found at the Georgia Nut Company?

A: We are still working on some of the environmental samples. I can’t tell you where exactly or how many environmental samples came back positive. The results indicate the presence of salmonella in critical areas of the processing plant and where there is potential for cross-contamination. I can’t say the positives were from a belt or a drain. We also don’t have the type of serotypes yet. But that becomes a moot point because you don’t want any type of salmonella at the plant.

Having seen what happened with peanuts, we certainly don’t want someone to get sick and die. First we must isolate product and give consumers advice, then we look to see if we can isolate where the problem occurred specifically and take corrective action.

Q: When FDA got positive results for salmonella at the Setton facility, why didn’t it hold a press briefing to inform the media as it regularly did during the Salmonella Saintpaul outbreak? Why is Dr. Acheson selectively releasing information the FDA considers important to only certain reporters?

A: I don’t know the reason for the change in policy. All I can say is that I didn’t get much of a break during the Salmonella Saintpaul investigation because of the frequently held press briefings.

Q: This slow trickle of piecemeal information is leading to confusing, inaccurate and often sensationalized reporting. The Associated Press quoted Acheson on the positive findings, but also reported inaccurate information on the extent of the expanded recall.

A: You are correct in pointing out that the AP and other newspapers were not right when they reported that Setton was recalling its entire 2008 crop. I kept seeing the word “entire”, which was never the case. .

Q: That confusion actually began early on during the original joint FDA/California Department of Public Health press briefing and got picked up from there in The New York Times, among other media outlets.

Is there any real change in the advice you’re giving consumers in terms of consuming pistachios? An article in the Sacramento Bee (April 8) gives that impression: It leads off: “Federal food safety officials have lifted last week’s blanket salmonella warning on all pistachios focusing on nuts now being recalled by a single San Joaquin Valley processor.” Isn’t there still a blanket warning to consumers to avoid eating pistachio products until they can verify none of the ingredients originate from Setton Pistachio?

A: There is no difference. Our advice to consumers remains the same because pistachios are used as an ingredient in a variety of foods. Consumers shouldn’t eat pistachios or food products containing them until they can determine if those products contain recalled pistachio products. Nothing has changed. The problem originally pointed to Setton and still does.

There is a problem or potential problem and consumers need to be worried if they got pistachios processed by Setton Farms. How do you know? Well you don’t. We’re telling consumers, don’t throw product out, just put it aside and as we get information, we’ll post the list of recalled products. Go in and check and see if your product comes out on the list, and if it does, don’t eat it and throw it out.

Q: When will they know it’s OK to eat it? This isn’t like fresh produce, where at a certain point, all product is out of circulation due to its perishable nature.

A: Over a certain amount of time, hopefully we’ll get most products out there that contain these things, and the consumer can say, ‘look it’s been a few weeks, and I am reasonably confident my products aren’t on that list and I’m going to eat pistachios.’

Advice has been the same all along. The only difference is that at the beginning of this week, Setton expanded its recall. Now it isn’t just product after September 1, 2008. We expect additional recalls, maybe different products, earlier code dates, and consumers should be aware of that.

Q: What actions can FDA take to alleviate these kinds of sweeping recalls and to improve its handling of these investigations in the future?

A: At FDA’s request, it has a contract with the University of California Davis to research chemical propylene oxide as a means of killing salmonella in pistachios and other tree nuts. The method has been validated to kill salmonella in almonds.

Q: But you’ve pointed out that roasting pistachios already provides a kill step. FDA says the Setton recall centered on the recontamination by raw pistachios, so in that case, a pasteurization process wouldn’t have changed the outcome.

A: Pasteurization could be an alternative food safety step. There’s more than one way to skin a cat. It’s about looking at what else could work. Roasting only works as a kill step at the right temperature, for the right amount of time, and deep enough to make sure it penetrates. You have to validate the process and make sure it’s implemented properly. Of course it’s all for naught if roasted product is then re-contaminated with raw product.

The point is that companies can do things to minimize risk. Designing the plant properly is important, but obviously more difficult and costly when retrofitting. There are a lot of things involved in food safety. Over time, we try and learn. It might be that now we think we’ve addressed 90 percent of the problem, five years later 95 percent, and five years later 98 percent. The goal is to minimize the likelihood the best you can.

The key issue the FDA desperately wishes to avoid any consideration of is whether its efforts actually help public health in these types of recalls. In a situation such as this — where, as the FDA spokesperson says, there is no indication of maliciousness, the vendor has a good reputation and has multiple audits — it is highly likely that by excluding this one shipper’s product from the market, the FDA is leaving the market to product no safer than the Setton Farms product. Indeed, because there are sub-standard operators in the world, the remaining product may, on average, be less safe.

What clearly has to change is that the FDA cannot be prosecutor, judge, jury and executioner. Simply screaming “public health” does not justify destroying Setton Farms because the FDA wants to “work with the industry to help understand the risks, to examine current pistachio practices that could lead to contamination with bacteria and measures to prevent contamination.”

This may all be some project to the FDA, but this company is the property of real people, it provides a livelihood for real people and it is not the FDA’s right to destroy it.

Our friendly FDA spokesperson speaks with certitude but is not convincing when saying:”… the bottom line is that somewhere along the line there’s been some kind of processing breakdown at Setton and we can all be certain of that.”

Actually we don’t think this consensus is justified. As of today, without a serotype match between the allegedly contaminated pistachios in Illinois and the plant, we don’t even know if the plant had anything to do with the contamination. After all, product sat at Georgia Nut Company for months — maybe it got contaminated there.

The FDA also just assumes it needs to do things although the legislative justification for doing so is dubious. For example, our spokesperson explains FDA’s position well: “First we must isolate product and give consumers advice.”

But one wonders if the FDA has considered that in a situation such as this, the “advice” can only be a reflection of the risk-tolerance level of the individual giving the advice. Unlike peanut butter, pistachios are not generally eaten by children; they are a relatively expensive item and are not generally eaten in great quantity. So what , exactly, does the FDA think the risk is?

Why doesn’t the FDA publish this assessment and allow citizens to make their own decisions rather than give its advice to consumers?

We suspect it is because the ludicrous nature of the “risks” FDA is acting against would soon cause people to ignore it, if not laugh at it. By the CDC’s reckoning, there are 76 million cases of foodborne illness and 5,000 deaths in the US each year from foodborne illness. So, if we have 305 million Americans and all Americans are equally vulnerable, there is a 24.918% chance of an American getting a foodborne illness and .0016% chance of an American dying from a foodborne illness during the course of a year.

Of course, these numbers are after the FDA’s vigilant market withdrawals, so the question is how much greater would the numbers be if they let the pistachios be sold freely? Would there be any difference? If the replacement product is less safe, wouldn’t the numbers actually be worse? Who would pay attention to such uncertain and inconsequential risks?

We let people ski without helmets, ski dive, hang glide, etc. — on what basis do we deny them some “risky” pistachios? It is preposterous.

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