SPECIAL ALERT
Watch Your Orders:
Product May Be Held At Border
CDC Blames Fresh: Ignores Horticultural Probabilities
The CDC, FDA and state health departments are not making many public announcements but
they are leaking information like sieves.
The public announcement by CDC is that the Salmonella Saintpaul outbreak continues to
sicken people. To date, there are 943 illnesses in 40 states, the District of Columbia and Canada. The latest
onset of illness is June 26, 2008.
The key official announcement from CDC is this:
Recently, many clusters of illnesses have been identified in Texas and other states
among persons who ate at restaurants. These clusters have led us to broaden the investigation to be sure that
it encompasses food items that are commonly consumed with tomatoes.
In a
front page article in The Wall Street Journal, claiming the focus of the government’s efforts is
now moving to jalapeños, the switch from tomatoes is explained this
way:
The CDC is focusing on 29 “clusters” of illnesses, Mr. Nowak said. A cluster is
created when two or more people become sick within a 10-day period after eating at the same restaurant. Most
of the restaurants serve Mexican food, and most of them are not chains, Mr. Nowak said.
While Mexican restaurants use large quantities of tomatoes, so do other types
—Italian and fast-food restaurants, for example. Yet virtually none of those types of restaurants has been
associated with a large percentage of illness clusters, the official said. That has led to the focus on salsa
— and in particular on jalapeños, medium-sized chile peppers grown in Mexico and parts of the Southwestern
United States.
CNN is
reporting that the US will “halt the shipment of ingredients common to Mexican cuisine from Mexico to the
United States” starting Monday. Tommy Thompson, former Secretary of the Department of Health and Human
Services, which controls both FDA and CDC, has been briefed on the situation and he explained the intent:
“…the plan involves intercepting food samples at the border and sending them to
laboratories to examine them for possible salmonella or E. coli.”
No official announcements have been made, but the intent is said to include holding
cilantro, jalapeño peppers, Serrano peppers, scallions and bulb onions at the border.
Three things are unclear:
- If the CDC and FDA think this step necessary for protecting public health, why are
they waiting until Monday? Is it possible that decisions on public health are being made to avoid
inconveniencing federal employees?
- How long will the tests take and will negative tests result in the product mean the product is free
to enter the US?
- All these products are grown in America as well as Mexico. Just because the
restaurants are Mexican doesn’t mean the food source is Mexican. Will similar restrictions be applied to
domestic producers?
Although we are told that jalapeño peppers are conducive to the growth of salmonella,
the long term of this outbreak now stretching seventy five (75) days and growing is making any fresh product
increasingly implausible as a source for the outbreak.
Growers we have consulted in this matter say a typical field of jalapeño peppers is
completely picked in 40 days. If we assume the jalapeño is at fault, the inspectors will be looking for
jalapeños from a field in continuous production and exporting to the US for eighty five (85) days. Though not
impossible, this is highly unlikely and would be easier to find by looking directly rather than hoping to find
a contaminated pepper to track back.
The longer this goes on the less likely a farm-based source is plausible. We would look
for a manufactured product. These products have a continuous source of production that lends itself to a long
outbreak. The manufactured products used in salsa directly, namely lime juice and jarred garlic, are
biologically not likely vectors for salmonella growth.
We suggested
fresh salsa distributed to foodservice and deli departments as being plausible. Bill Marler, the
plaintiff’s indispensible resource in food borne illness litigation, reports on his web site cases of severe
gastronomical distress related to
tortillas, and Europe’s Rapid Alert System has previously found
Salmonella in tortillas.
We decided to run this special alert as we have many readers who export from Mexico or
import to the United States from Mexico. We wanted to warn them to make cautious judgments about sending
product to the border until the situation is clarified.
We also write because over this July 4th weekend, in which we celebrate our
nation’s independence from the dictates of arbitrary power, we wanted to call for the establishment of
procedures to restrict the arbitrary discretion of CDC and FDA.
We now see that executives in these agencies are casual enough to destroy people’s
property — to crush a whole industry — without seriously studying the consumption data and noting as simple a
thing as that few people were getting sick at fast food restaurants that are enormous users of tomatoes.
Now they may be preparing to destroy the jalapeño pepper industry and other fresh
produce segments.
This is madness, and done on nothing but their own hunch represents a kind of
unconstitutional taking-of-property without compensation.
On this 4th of July weekend, we should remember that we did not reject the
tyranny of George III only to see our right to pursue happiness snatched from us by the careless and arbitrary
tyranny of FDA and CDC.
Special Edition IX —
Salmonella Saintpaul Outbreak…
Concerns About FDA/CDC
Bob Backovich,
Industry Giant,
Passes Away
Just as we were going to press, we received sad news:
I don’t know whether you’ve heard the news that Bob Backovich passed away last
night of a rare kidney ailment. He was truly one of the old lions of the industry. He precisely fit his
nickname of “The Boomer”.
— Grant Hunt
Grant J. Hunt Company
Bob was a giant in the industry, Chairman of PMA, a leader in promoting nutrition
education and, for the last 20 years, he never failed to write us at PRODUCE BUSINESS whenever we wrote about
the need for quality product.
Bob
helped us analyze the growth of retail
bureaucracy in a piece for the Pundit.
We never spoke to him about this Salmonella Saintpaul outbreak, but we can imagine his
distress at seeing healthy products disparaged by such an issue.
Our condolences to Bob’s family and friends. Special Edition IX —
Salmonella Saintpaul Outbreak…
Concerns About FDA/CDC
Trace Back The Control Group
One hope for solving this problem and clarifying
the cause of this outbreak came out in the FDA/CDC’s recent conference
call. It was good news to learn that CDC was basically starting anew
and doing new survey work with people who became ill after June 1,
2008. This survey work would involve additional questions and
presumably build on learning from inadequacies in the initial
investigation of those who fell ill in April and May.
Right now there are 179 people who say they fell
ill in June, and this number will presumably increase as more reports
come in.
What was shocking — and very disappointing for
the produce industry — was word that even in this new investigation,
CDC is not doing any traceback of the control group. This group
consists of people similar in demographics to the ill people but who
did not fall ill.
Our
interview with Michael T. Osterholm PhD, M.P.H., focused on the
necessity for doing traceback with the control group. Here is what Dr.
Osterholm said:
…it is not biologically plausible to have
Mexico and Florida both at the source of this outbreak. It epitomizes
the ineptitude of the investigation. FDA and CDC should have obtained
tomato product consumption information from both outbreak cases and
controls. They needed to conduct full fledged tracebacks all the way
back to the source not only of the sick cases but of the control group
as well.
The epidemiology conducted to learn what
product is associated with this outbreak by interviewing those sick
and those not sick on what they were eating is a prerequisite but the
epidemiology needed to go further. It was critical for the
investigators to learn the locations of where both the cases and
controls ate tomatoes and trace back from there.
When doing the traceback, you may come up
with a few possibilities of where the tomatoes came from. If you
collect data over time of the cases and controls, using the same
methods to make the product association, you may find 85 percent of
outbreak cases trace back to a certain field or grower, or re-packer
versus the control product. Then you begin to get a much better handle
on where product came from.
Q: Why did the government forego this
strategy?
A: FDA and CDC have not made this a
priority. They will never find a silver bullet by just tracing back a
product. They’re looking for a cluster that matches up exactly with
the one gun barrel. They’re under the false impression that they’re
going to get a clean, clear-cut answer by finding the magic cluster.
They need to do this case/control approach.
Now whatever happened with the initial
investigation, whatever judgments or considerations were made, this
much is beyond dispute: It didn’t work.
A quote attributed to Albert Einstein defined
insanity as doing the same thing over and over again yet expecting
different results. So surely CDC should be open to enhancing its
methodology. Certainly there is no way that doing a traceback on the
control group could hurt.
We have Dr. Osterholm, a highly credible person
with extensive experience, saying this is a necessity. This is from a
man who was doing traceback in Salmonella investigations on tomatoes a
decade ago.
So, we have a methodology that has not been
working, a highly credible source suggesting a specific improvement in
that methodology, yet when asked, CDC gave a simple response of no, it
is not tracing back the control group.
This should be a major concern for the produce
trade associations, which should be requesting that CDC add this to
their methodology right now, while it still can, so that this
post-June 1, 2008 survey will be more productive and more likely to
produce an answer as to the source of the salmonella.
This CDC also needs to consider its dismissive
manner. An issue such as this merits an explanation. In light of the
failure of the last traceback and the input from Dr. Osterholm, if CDC
doesn’t want to do a traceback on the control group, it should have
the decency to explain why to the general public.
Does CDC lack the resources required? Does it
have a substantive disagreement with Dr. Osterholm?
The people at CDC are hired by the citizens of
America to handle this portion of their affairs. A decent respect for
the people who pay the bills requires CDC to be more transparent in
its decision-making process.. Special Edition IX —
Salmonella Saintpaul Outbreak…
Concerns About FDA/CDC
‘Produce’ Or ‘Food Items’
Although CDC’s Dr. Griffin last Friday said,
“This is a produce
outbreak,” to distinguish it from a tomato outbreak, CDC’s Dr.
Robert Tauxe used a different word in an interview with
USA Today. He said “we’re broadening the investigation to be
sure it encompasses food items that are commonly consumed with
tomatoes.”
Obviously there is a big leap from “produce” to
“food items,” so CDC should A) use words more carefully to avoid
confusion, and B) clarify this issue very quickly.
The big produce items that have been floating
around are all linked to Mexican food. A quick glance at the
CDC map of the outbreaks shows this is an outbreak focused on the
Mexican food belt:
Texas, New Mexico and Arizona have over half of the
illnesses, and other areas, such as Chicago, all have large Mexican
populations.
In the same USA Today article, a well
known food safety expert speculates:
If not tomatoes, what else? “Something that
people find difficult to remember but which is always served with
tomatoes,” says Tauxe.
That would put salsa, jalapeño peppers,
green onions and cilantro at the top of the list of potential
culprits, says Doug Powell, director of the International Food Safety
Network at Kansas State University in Manhattan, Kan.
Both Dr. Tauxe and Dr. Powell are correct,
except there is no logical reason to limit it to produce. Tortilla
chips and tortillas would also fit the bill and as they often come
free at a Mexican restaurant or as an accompaniment to a dish, it is
logical to think people might not remember them.
One gets the feeling, though, that CDC is just
grasping at straws. It has no more reason to think it is any of these
products than it is chicken. That is why they are so loathe to give up
on tomatoes.
Special Edition IX —
Salmonella Saintpaul Outbreak…
Concerns About FDA/CDC
Getting Our Money Back:
Waive Sovereign Immunity
Dr. Robert Tauxe, M.D., M.P.H., was representing CDC on the most recent conference call.
He is both smart and knowledgeable; he has contributed additional information to articles we have run on the
Pundit, as you can see
here.
During the CDC’s most recent conference call, he was at pains to point out the complexity of figuring out the cause in an outbreak such as this and so compared the role of the CDC to that
of a detective.
Dr. Tauxe is both articulate and frank and so we accept his description. We, do, however,
wonder if he has been reading the papers lately:
U.S. to Pay Millions in Lawsuit Over Anthrax Innuendo
The U.S. government will pay $4.6 million to settle a lawsuit brought by Steven
Hatfill, a former U.S. Army biodefense researcher who was intensively investigated as a “person of interest”
in the deadly anthrax letters of 2001, the Justice Department announced Friday.
The settlement, consisting of $2.825 million in cash and an annuity worth $1.8
million that will pay Hatfill $150,000 a year for 20 years, brings to an end a five-year legal battle.
Hatfill, who worked at the army’s laboratory at Fort Detrick in Frederick, Maryland,
in the late 1990s, was the subject of a flood of news media coverage beginning in mid-2002, after television
cameras showed FBI agents in biohazard suits searching his apartment near the army base. John Ashcroft, then
the attorney general, later called him a “person of interest” in the case on national television.
In a news conference in August 2002, Hatfill tearfully denied that he had anything
to do with the anthrax letters and said irresponsible news media coverage based on government leaks had
destroyed his reputation….
Mark Grannis, a lawyer for Hatfill, said his client was pleased with the settlement.
“The good news is that we still live in a country where a guy who’s been horribly
abused can go to a judge and say, ‘I need your help,’ and maybe it takes a while, but he gets justice,”
Grannis said….
“As today’s settlement announcement confirms, this case was botched from the very
beginning,” Holt said. “The FBI did a poor job of collecting evidence, and then inappropriately focused on one
individual as a suspect for too long, developing an erroneous theory of the case that has led to this very
expensive dead end.”
The parallels to the Salmonella Saintpaul outbreak are pretty clear. A botched
investigation, with the CDC failing to do control group tracebacks, led them to inappropriately narrow their
focus to tomatoes prematurely.
There is, however, a difference. In both cases, the government, acting as a detective,
came to a conclusion. In the case of the Anthrax situation, the government violated all the procedural
safeguards put in to protect victims against the capricious use of governmental authority.
So the detective is obligated to present his case to the prosecutor… if the prosecutor
does not think the case strong enough, it goes no further. If he thinks the case has merit, the prosecutor has
to persuade a grand jury to bring an indictment. If the grand jury won’t indict, the case goes no further.
Then there must be a trial and a judge or jury must be convinced. Finally there are several opportunities for
appeal.
This is a very difficult and expensive system. However, we, as a people, are skeptical
of governmental authority and so would not accept a system whereby the detective gets to also be the
prosecutor, grand jury, judge and jury and appellate court on his case.
Yet this is precisely the way the CDC/FDA work on food safety outbreaks. Without any
checks on their judgment or power, they do what they please regardless of the cost to others. In this case,
it’s the cost to the tomato industry — although by vaguely implying other produce items may be at fault, they
are already spreading the costs to other items as consumer confidence is surely being diminished.
Now we
have suggested various plans to reduce the likelihood of a bad decision as well as to limit the
discretionary use of governmental power. For example, we proposed the use of a Team B approach, modeled after
a CIA effort to improve analytical quality and avoid mistakes.
Another way to make less likely mistakes such as we have seen in the Salmonella
Saintpaul investigation is to use the power of the courts.
Right now the problem is that CDC and FDA personnel can be horribly wrong, yet neither
the organizations nor the people involved will experience any consequences.
In the current case, hundreds of millions of dollars of losses have been incurred with a
very dubious benefit to public health. If tomatoes are not the cause, then the losses had no public health
benefit at all.
Now in the case of the anthrax “person of interest,” the government settled a lawsuit
without admitting guilt. Presumably the government wouldn’t pay $4.6 million if it didn’t think it was in the
wrong.
Now the question is where do the tomato growers go to get their compensation?
One possibility is for industry to ask Congress to waive the doctrine of sovereign
immunity – which generally precludes suing the state. This would open the door for an industry lawsuit against
CDC and FDA.
This would have three beneficial effects:
- Those who lost money due to the way CDC and FDA handled this matter would have an
opportunity to get it back.
- The discovery process would reveal many problems in CDC and FDA, and we could use
that information to build a better food safety system.
- There would be negative consequences for having made a bad decision, which will
serve as a useful tonic to improve future decision-making.
What is clear is this: The detectives at CDC cannot be allowed to become some fanatical
Inspector Javert relentlessly pursuing Salmonella or other pathogen without regard to cost. One good way to ensure this
would be to make sure mistakes have consequences.
A Congressional waiving of sovereign immunity would be a fine way to teach that lesson.
Special Edition IX —
Salmonella Saintpaul Outbreak…
Concerns About FDA/CDC
FDA/CDC Violate
Their Own Speculation Policy
FDA and CDC have made a point that they don’t
release their speculations. So, for example, neither organization will
name any other item, beyond tomatoes, that they are considering as the
source for the Salmonella that has spread in this outbreak.
This is a reasonable enough policy, if it is
followed consistently. Last Friday, however, when CDC’s Dr. Griffin
announced that this was a “fresh produce” outbreak, we think she
violated the same policy.
If CDC doesn’t know with sufficient certainty
what item it is willing to publicly declare, then, obviously, it
doesn’t know what particular category — such as fresh produce.
Remember, items such as guacamole or salsa can
be manufactured items produced in food processing plants. They are not
fresh produce.
By announcing that it is a fresh produce
outbreak but then refusing to define the items of interest, they
implicate the whole industry.
Now the fear — quite a reasonable fear — is that
if the FDA and CDC say they are looking at jalapenos or cilantro,
people will take a “better safe than sorry” attitude and avoid the
products.
But, having defined the problem broadly as
“produce,” consumers may start to take a similar attitude toward the
whole department.
It is another example of sloppy management of
the outbreak communication effort. Special Edition IX —
Salmonella Saintpaul Outbreak…
Concerns About FDA/CDC
Four Talking Points
For Dr. Acheson To Consider
Dr. David Acheson, FDA’s Associate Commissioner for Foods, devoted a part of the Tuesday
evening press conference to looking to the future and ways to do things better. It was truly thin gruel, and
in many ways highly insulting to the produce trade.
First, he suggested the possibility of an “interagency task force,” which pretty much
made us yawn. It is shocking to learn they don’t have one already. What they really need, though, is not so
much: “better coordination” but someone in charge. Think Dwight D. Eisenhower in World War II. He didn’t have
an ”inter-army task force” with the British; Montgomery was under Eisenhower’s command. If next time one
person doesn’t come out and say, “I am in charge of the federal government’s actions regarding this outbreak,”
we will have failed.
Second, Dr. Acheson gave this pointless oration on the “legal and ethical” obligations
of the industry. In the first place, the guy has some nerve. Where does he come off lecturing the industry
about its ethical obligations? Who does Dr. Acheson think he is — Moses? Jesus Christ? Muhammad? Buddha?
Aristotle? On what basis does he assume he has the special competency to dictate ethics to industry members?
He frankly owes the trade an apology for his presumptiveness.
Why doesn’t Dr. Acheson give a speech reflecting on his own ethical obligations and
discuss how bankrupting tomato farmers, depriving migrant workers of their source of sustenance and urging
poor people living on food stamps to throw out perfectly good food comport with his own ethical obligations?
It was a truly disgusting line. The Secretary of Health and Human Services should take
him to the woodshed and remind him that he is not the moral superior of industry members. If members of the
trade require ethical guidance, they are quite capable of getting it from their archbishops, not the Associate
Commissioner for Foods of the FDA.
Beyond that, the repetition that industry members have both a legal and ethical
obligation to provide food that is safe, wholesome and free of contamination would have been more helpful if
it showed any evidence of serious thought.
That food ought to be safe is unobjectionable. So should cars, airplanes, trains and
whatnot. But we don’t define “safe” in these contexts as meaning never an accident.
Throwing into his oration the notion that the industry has an ethical and legal
obligation to produce food “free of contamination” is a sign that Dr. Acheson is engaging in
cant rather than a serious assessment of the situation. Yes, that is how things have been interpreted
legally, but there is a real question as to whether that makes any sense as a public policy.
In fact, there are serious trade offs between the cost of enhancing food safety and the
ability to provide the world with low cost fresh food. Serious people now realize that we have to abandon the
delusion of a zero-tolerance policy.
It is in many ways a shame that the industry confronted these issues in the context of
the spinach outbreak of late 2006. We were dealing with processed product and dealing with product that the
industry elected to market as “no need to wash” and “ready to eat” – those marketing phrases carry with them
additional obligations to consumers.
However, growers of bulk, field-grown commodities are offering the world food raised in
the earth and exposed to all elements. If consumers are really concerned about safety, perhaps because of a
compromised immune system, they should cook the food well and not eat it raw.
Ethical obligations are — Dr. Acheson’s pronouncements excepted — complex. One farm
technique will lead to deaths by starvation because people cannot afford the food; still another may produce
plentiful food, but the occasional foodborne illness will afflict.
There are also other ethical obligations — say truth-telling — and so the industry must
make certain, as we discussed
here, that we are honest when we market product to those with immature or compromised immune systems.
Law is also a complex subject. The whole legal system in this area is best understood as
the way society elects to compensate the people damaged by society’s unwillingness to pay the price to grow
everything in an Intel-like “clean room”
One of the most important lessons of this outbreak is that we can’t leap to action.
There are thousands of cases of Salmonella every month. The FDA/CDC have adopted a bizarre position. As long
as they don’t see an illness, everything is OK, but if an illness happens to be brought to their attention,
they will pursue the source more diligently than the crusaders pursued the Holy Grail.
The future must be built upon reasonable expectations for the prevalence of pathogens
and then much effort to continuously make food safer and safer.
Third, we have come to wish that Dr. Acheson would just stop talking about the produce
industry. Every time there is one of these calls, he comes up with some new tidbit that he shares with all the
reporters. It is not typically that he is wrong, but his information is out of context and atypical. It is as
if a Martian came to the earth and we educated him on the planet by having
Ripley’s Believe It or Not make a presentation.
This most recent call, Dr. Acheson blamed the industry for the slowness of the
traceback, claiming that “typically” the traceback records are maintained on paper as opposed to
electronically. He basically portrays the produce industry as a bunch of hicks without computers.
How could this possibly be true? We know Wal-Mart is involved because New Mexico named
them. Wal-Mart probably accounts for about 25% of all tomatoes sold at retail, and every single one of its
suppliers has a computer, and they are all on
Retail Link.
The big fast food chains, such as McDonald’s, Burger King, etc., certainly do not buy
from anyone without a computer, and they run audits to check traceback ability. So, what is Dr. Acheson being
told?
In addition, as revealed in an interview we ran
here with Jim Gorney of the University of California, Davis, it is the epidemiology that is slow, not the
traceback.
We are not saying that the industry can’t do better on electronic record-keeping and
enhanced traceability. It can and, of course, we are working on it with a whole initiative in this area. But
to say that this is “typical” seems highly unlikely.
Fourth, Dr. Acheson’s final point was to urge Congress to give FDA the authority to
establish mandatory “preventative controls” as was called for in the FDA’s Food Protection Plan produced last
November. Mandatory preventative controls is referring to the ability to create rules requiring producers to
observe certain conduct — say put traps ever 50 feet — as opposed to inspect for safety after the production
is done.
We have no particular objection to this. As we mentioned
here, though, we think it is a bit of red herring. It implies that this outbreak is a function of growers
refusing to do the right thing – a proposition for which there is, literally, no evidence.
What actually concerns us, as we mentioned
here, is that FDA treats all growers the same. No amount of ”preventative controls” exempted a grower from
the FDA’s advisory for consumers not to eat certain types of tomatoes from certain places.
If the FDA really wants to enhance food safety in the future, it will look carefully at
revising this approach. Had FDA only said that retailers and restaurants should exclusively buy tomatoes from
producers that are third-party audited to meet X standard, it would have encouraged massive investment in food
safety in all sectors of the produce trade.
As it stands the message is, “Don’t bother!” That is dangerous. | ![Jim Prevor's Perishable Pundit [header]](images/pp_headtop_842x45.jpg){kind=small}
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