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Perishable Pundit
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SPECIAL EDITION III —
Major Retailer, California Health Official and FDA Weigh In On Pistachio Recall

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.




SPECIAL EDITION III —
Major Retailer, California Health Official and FDA Weigh In On Pistachio Recall

Retail Exec Defends Setton
And Lambasts FDA’s Actions

Here at the Pundit, we experience the horror of the way the FDA behaves in a very specific manner. We learn that FDA agents have intimidated everyone who could credibly speak up against the way the FDA behaves.

The importance of this subject goes well beyond food safety. If the government is free to act in an arbitrary and capricious manner, people start to fear to speak up because they do not want to be the next victims. In a real way freedom of speech is lost. The right to petition the government is lost. Democracy itself is at risk.

Here is a conversation we had with one of the most powerful and well-respected retail executives in America. Yet for all the esteem he is held in, he dare not speak out, lest he put his own organization at risk.

But if they love not only food safety but also freedom, FDA executives ought to know that this is what dozens of the most knowledgeable people in the industry want to scream… if they care about food safety, the FDA executives will take this message to heart… if they care about freedom in America, they will think about how to organize their actions so that knowledgeable experts are not afraid to speak out:

Q: Could you shed some light on this Pistachio recall? I know you abide by the highest food safety standards and require the same of your suppliers. Yet some of the recalled products carry your own brand. Wouldn’t your strict food safety and auditing procedures have caught the problems FDA claims to have discovered at Setton Pistachio’s facility?

A: I bet most third-party auditors have visited this facility, and I don’t want to throw any under the bus because Setton is probably audited five times a week. Lots of reputable companies audit Setton. Safeway would order its own audit, Costco would have its own audit. Wal-Mart the same. Setton is a great vendor.

Q: Then why is Setton undergoing this massive recall of its products? Are you saying it’s unwarranted?

A: Setton is being treated unconscionably. The science doesn’t support FDA’s actions.

The whole recall is strange, really strange. FDA pronounces they’ve got a smoking gun, discovery of salmonella in the Setton plant as evidence they were right. That’s crazy. FDA finds two environmental positives out of 200 tests and the positives were way off of production.

If you do environmental samples in any factories across the country you’ll find salmonella. Investigate any food processing plant… if you look hard enough you can find it. Salmonella is all over the place. If we swab the soles of our employee shoes, five out 10 will test positive for salmonella. Salmonella is ubiquitous.

Q: FDA’s Dr. Acheson claims the positive samples were in “critical areas” Investigators said they observed situations where raw and roasted pistachios were not properly segregated during the processing stages, which could have resulted in cross contamination.

A: We think Setton is getting dragged through the mud for different reasons, and the overriding one has to be the peanut deal. FDA is trying to save face. People are trying to save their jobs at FDA. In the end, as they always do, FDA will fall on its public health sword.

I don’t know what Acheson means by “critical areas.” Acheson also said there were 18 positives found in raw material since September. There is no proof of that. Even if there were positives, the company runs the raw product through again and re-roasts it. That’s normal FDA-approved industry practice.

The whole thing doesn’t make sense. Nothing has been confirmed. This Georgia Nut Company says it found four different salmonella serotypes in its testing, yet it can’t match salmonella up to anything at Setton.

It’s odd. There’s never been an issue with pistachios. Pistachios are not considered a high risk food. Pistachios are a non-hazardous product because of pH and water activity; it’s a dry roasted nut.

Q: Are all pistachios roasted before they’re sold at retail? Setton said its raw in-shell pistachio shipments are NOT affected by this recall expansion.

A: Yes, some are sold raw. My understanding is those raw in-shell products are going to a roaster, who will roast them. That product is not going through the Setton plant. That’s why it’s not part of the recall.

There are still active peanut butter recalls every day. People got sick in the peanut butter outbreak and the government didn’t tell consumers, ‘Don’t eat any peanuts.’ Why isn’t FDA applying the same standard to pistachios as it did for peanuts in issuing its warning?

In the case of the peanut outbreak, the company implicated was egregious. They knowingly sent out contaminated food. But FDA makes no distinction between that company and Setton, a reputable, honest firm with high food safety standards and regular audits.

Setton is a good company run by good folks. FDA’s behavior is a travesty. It’s the most offensive investigation. Serious errors are being made. We need to go after this. FDA can’t be allowed to operate this way, destroying good companies, taking down entire industries.

No it can’t. The FDA is destroying a company and an industry without any benefit to public health. It is behaving as a bully.

In allowing this type of discretion to regulators lies the road to serfdom.




SPECIAL EDITION III —
Major Retailer, California Health Official and FDA Weigh In On Pistachio Recall

News Flash: Every Plant Handling Raw Pistachios Has Salmonella! (But Roasting Kills The Pathogen)

Sometimes short-and-sweet can be very revealing. We asked Pundit Investigator and Special Projects Editor Mira Slott to find out what role the State of California is playing in regard to the investigation of Setton Pistachio:

Ralph Montano
Spokesperson
California Department of Public Health

Q: When I called the California Department of Agriculture, a spokesperson said FDA and California Department of Health have jurisdiction on this investigation but the California Department of Agriculture does not. Is the state government conducting an investigation of the farms that supplied the raw product to Setton Pistachio?

A: Concerning farms, one can always assume there will be salmonella in the environment. Pistachios are not eaten raw. They are to be roasted and prepared for consumption. So when Setton is selling the raw nuts in the shell, it is selling them to someone who is then going to roast them and put them into products for consumption. That roasting process gets rid of the salmonella that could be occurring. This is why farms are not being investigated.

The problem at Setton that has been brought out by FDA is the possible comingling of raw and finished product resulting in contamination. That’s why FDA is not going back to the farms. That’s why the recall does not include Setton’s raw in-shell products that are being shipped for further roasting.

Q: FDA says it has found salmonella in critical areas at the Setton facilities. Has the California Department of Public Health done its own tests? If so, what are the results?

A: Laboratory analysis has been partially completed by FDA laboratories and salmonella has been positively identified in the environmental samples and the finished product samples, which we collected from Setton in its facilities. More detailed analysis for genetic identification is pending.

We thank Ralph Montano and the California Department of Public Health for working to keep the industry and the public informed about the status of the investigation. This brief interview brings up three very important points:

1) Pathogens are expected in fields and, with pistachios, roasting is expected to kill them. Unlike in the spinach outbreak, where an enormous investigation was conducted in an attempt to ascertain how the pathogen — in that case E. coli 0157:H7 — got in the field, in this case the State isn’t even bothering to attempt to find that out because it doesn’t matter.

2) This means that the finding of salmonella in the plant is of no consequence. It is expected that there will be salmonella on the raw nuts and, as such, in a factory having raw nuts.

3) Genetic identification has not, at least as of yet, tied the salmonella found in the plant to the salmonella supposedly found in the pistachios at Georgia Nut Company. This answers the question we asked here, which was why the FDA was leaking information to favored reporters rather than holding conference calls and issuing press releases.

Now we know the answer: FDA played the AP like a flute getting them to report “news” that Salmonella was found in the plant when that news is irrelevant. Salmonella is expected to be found in every plant handling raw pistachios, and no genetic identification has been made that the salmonella found in the plant is connected to the salmonella alleged to have been on pistachios at Georgia Nut Company.

One broader question: Does the acceptance of pathogens in raw products that will be further processed with a “kill step” increase their prevalence in the environment and make it more likely that products sold to be eaten raw — like leafy greens — will become contaminated?




SPECIAL EDITION III —
Major Retailer, California Health Official and FDA Weigh In On Pistachio Recall

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.




SPECIAL EDITION III —
Major Retailer. California Health Official and FDA Weigh In On Pistachio Recall

Is FDA Guarding Against Ulterior Motives In Accepting Test Results From Unrelated Private Companies?

One issue raised by the actions of FDA in the Setton Farm pistachio recall is the appropriateness of FDA’s reliance on tests done by third parties.

If a company turns over its own test results, that is unobjectionable and, of course, FDA and USDA and state authorities do their own tests.

In this case, though, it was a private company, Georgia Nut Company in Illinois, that did the tests which indicated there were four types of salmonella on Setton Farms pistachios.

Yet the use of private company testing for this purpose is very problematic.

What steps did the FDA take to ensure this is not one company trying to harm another?

We have no reason to believe there is such a problem in this case, but it is easy to see one arising. Competitors, a desire to buy another company’s facilities, love triangles, affairs, personal vendettas, industrial sabotage… any number of things could lead a company to drop a pipette with a pathogen on some product.

The FDA probably should treat third-party private reports as nothing more than an invitation to investigate. Certainly the FDA needs clear procedures established on how it will safeguard companies against malicious reports.

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