FDA ‘Spokesperson’ Justifies Reasoning Behind Pistachio
of Article: http://www.perishablepundit.com/
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
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
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
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
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
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
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
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
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
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
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
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
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.