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In an astonishing display of what can only be described as chutzpah* Del Monte sued the FDA for insisting on a recall last March of its cantaloupes likely to be contaminated with a toxic form of Salmonella Panama. Now Del Monte is also suing the State of Oregon.

On what grounds?

Notably, “[t]he FDA investigation ultimately found no connection between Del Monte Fresh cantaloupes and any cases of Salmonella Panama, including in Oregon,” the company says. “FDA issued a notice ending the recall on July 29, 2011.”

The CDC thinks otherwise.  Its investigations pointed to imported Del Monte cantaloupes as the source of an outbreak that affected 20 people in several states:

Twelve of 16 ill people reported eating cantaloupe in the week before illness. Eleven of these 12 ill people ate cantaloupes purchased at eight different locations of a national warehouse club. Information gathered with patient permission from membership card records helped determine that ill persons purchased cantaloupes sourced from a single farm. Product traceback information indicated these cantaloupes were harvested from single farm in Guatemala.

FoodSafetyNews reviews the history of this particular recall.  It agrees with Del Monte that tests performed in April on cantaloupe samples from the Guatemala farm came out negative for Salmonella and that the FDA has now ended the recall.  But:

Del Monte had announced the recall in March, after the suspect melons had passed their shelf-life date. It is not clear whether any of the cantaloupes tested were actually the suspect melons. In foodborne illness investigations, samples of the food from the same batch eaten may no longer available by the time the connection to an outbreak is made. Epidemiology, rather than a contaminated sample, is the evidence that points to a likely source.

For these reasons, attorney Bill Marler terms the lawsuit “frivolous.”  He is suing Del Monte on behalf of a sick client.

Public health agencies doing their jobs to protect the public now have to defend against lawsuits like this?  Putative cause is no longer enough to order recalls?

U.S. courts are not famous for understanding epidemiology or other aspects of public health and I’m wondering what effect this suit will have on public protection against foodborne illness.  What standard of proof will the courts require?

Lawsuits are chilling.  Congress has just granted the FDA the authority to order recalls.  Food producers were not happy about that provision.  This is one way to get around Congress and the FDA.

It is worth asking who gains and who loses from lawsuits like this.

*Hence: chutzpah, which if you aren’t familiar with the term, is the Yiddish word for outrageous audacity.

I’ve been rounding up information about the Cargill recall of ground turkey contaminated with Salmonella Heidelberg.  William Neuman at the New York Times related the story on August 3. Same old same old.

Cargill is a huge company with, as Bill Marler counts them, a long history of food safety problems.  Did Cargill not bother to test for pathogens?   As I explain in my book Safe Food: The Politics of Food Safety, no meat company wants to test for pathogens.  If they found pathogens, they would have to recall the products.

And where was the USDA in all of this?  Best not to ask.

The USDA was testing.  The testing found Salmonella.  The USDA did nothing.

According to the Wall Street Journal,

Federal officials said they turned up a dangerous form of salmonella at a Cargill Inc. turkey plant last year, and then four times this year at stores selling the Cargill turkey, but didn’t move for a recall until an outbreak killed one person and sickened 77 others.

How come?

Food-safety specialists said the delay reflected a gap in federal rules that don’t treat salmonella as a poisonous contaminant, even if inspectors find antibiotic-resistant forms such as the Heidelberg strain implicated in the latest outbreak.

But CDC investigations show that turkey-related illnesses have been reported for months.  Despite the reports, the USDA took its own sweet time insisting on a recall.

The rationale for the delay is—get this—the USDA believes it does not have the authority to order recalls for any contaminant except E. coli O157:H7.  It has no authority to recall meat contaminated with Salmonella or other toxic forms of E. coli.

Or at least that’s how USDA interprets the legal situation (for the history of all this, see Bill Marler’s summary.

One reason for the USDA’s foot-dragging must surely be pressure from the meat industry which wants as little testing as possible and preferably none.  The meat industry would rather leave it up to you to cook your food safely.

According to a report by Elizabeth Weise in USA Today,

The reasons these bugs aren’t currently regulated are a mix of politics, money and plain biology — the bacteria are constantly evolving and turning up in new and nastier forms, making writing rules about them a bit of a nightmare. For example, the German E. coli variant that sickened more than 4,075 in Europe and killed 50…wasn’t known before this spring.

The meat industry takes advantage of this situation and argues:

“We don’t have a true baseline determining the prevalence of these organisms in the beef supply,” says Betsy Booren of the American Meat Institute (AMI) Foundation, the research arm of AMI. Without knowing how common they are, it’s impossible to say whether they should be considered adulterants, she says.

What they seem to be saying is that meat always has bacteria on it.  And just because these particular bacteria can kill people doesn’t mean the industry is responsible if anyone gets sick.  But shouldn’t the industry be doing a better job?

In Food Safety News, Michele Simon has a terrific analysis of the safety loopholes that allow this absurd situation to continue:

How did the meat industry get so powerful that it can keep USDA from doing its job? Now, instead of preventing illnesses from occurring by requiring testing with teeth, we have USDA regulations that are so lax they allow almost half the samples tested at ground turkey plants to be contaminated with Salmonella — a pretty easy standard to meet. And one that allowed this outbreak to occur.

I keep asking: how much worse does it have to get before Congress does something about ensuring safe food.  Cargill’s inability to protect the public from unsafe meat is reason alone to create a single food safety system that unites the functions of USDA and FDA.

If Congress isn’t ready to take that step, it could at least give USDA the power to act and the FDA the funding it needs to do its job.

At TPMDC, Brian Beutler explains why the U.S. does not have enough money to pay for food assistance programs, safety regulation, better school food, or support for sustainable agriculture.

Yesterday, USDA announced its new Food Safe Families campaign to get you to pay attention to food safety procedures in your kitchen.  These, as always, are:

1. Clean: Clean kitchen surfaces, utensils, and hands with soap and water while preparing food.
2. Separate: Separate raw meats from other foods by using different cutting boards.
3. Cook: Cook foods to the right temperature by using a food thermometer.
4. Chill: Chill raw and prepared foods promptly.

The media campaign, which reportedly cost $2 million, comes with a graphic that can’t be all that expensive:

So what is the $2 million for?  According to Food Chemical News (June 28):

The campaign, which will feature public service announcements in English and Spanish, centers on “humorous over-the-top depictions of the four key safe food handling behaviors”….The campaign will include ads on television, radio, print and websites, along with an integrated social media program.

As it happens, a reader sent me the preliminary “concept” version of this campaign (thank you kind reader).   Trust me, this campaign is worth a look, and Food Safety News has some of the videos.

Here’s my favorite concept:

Yes, this is a baby pig in a sauna.  Humorous maybe, but how will it convince anyone to clean up the kitchen?

Two other points:

• None of the concepts seem to have anything to do with food.
• All of them are about your responsibility for food safety.

But the big national outbreaks we’ve been experiencing lately are from foods that are already contaminated by the time they get to you.  Following food safety procedures makes good sense, but that’s not where the problem lies.  They would not help you much with contaminated raw sprouts, for example, unless you cook them (not a bad idea these days).

To stop food safety problems at their source, we need a functional food safety system.  This means rules that require all producers to follow food safety procedures and a government with the authority and resources to make sure they do.

Will we ever get a food safety system like this?  And how bad will things have to get before we do?

In an action highly unusual for the FDA, the agency has released a new “special report” on what it is up against as it tries to get a handle on the safety of imported foods.

Pathway to Global Product Safety and Quality points out that imported foods account for:

• Between 10% and 15% of all food consumed by all U.S. households
• Nearly two-thirds of all fruits and vegetables
• 80% of seafood

And imported foods have increased by at least 10% during each of the last seven years and are expected to increase by 15% per year for the next several years.

The New York Times notes that in 2008 the FDA would have needed “1,900 years to check every foreign food plant at its rate of inspections at the time.”

That’s not all.  According to FDA:

Manufacturers and producers…face intense pressure to lower costs and improve productivity, fueling a cycle in which the quest for efficiency leads to increased production abroad and higher volumes of imported products to regulate.

Goods entering the U.S. will come from new and different markets, flowing through long, multistep processes to convert globally-sourced materials into finished goods.

The shift in global product flows will make it difficult to identify the “source” of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities.

And it is not just legal activity that poses challenges for the FDA. Increasingly, the agency must contend with ever more sophisticated threats of fraud, product adulteration, and even terrorism.

The FDA illustrated its report with terrific graphics.  My favorite is the supply chain for canned tuna:

What will the FDA do about this problem?  It says it will:

1) Assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, develop a global data information system and network.

3) Expand capabilities in intelligence gathering and use.

4) Allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

The FDA released its report on practically the same day that the Health and Human Services Inspector General’s office released a report highly critical of the FDA’s ability to monitor the safety of imported foods.

Because FDA’s food recall guidance is nonbinding on the industry, FDA cannot compel firms to follow it and therefore FDA cannot ensure the safety of the Nation’s food supply.

FDA did not always follow its own procedures to ensure that the recall process operated efficiently and effectively.

This kind of criticism is not new.  Just last month, the GAO issued a critical report on the FDA’s problems regulating the safety of imported seafood.  The FDA’s difficulty with recalls is that until Congress passed the food safety act last year, FDA did not have the authority to order recalls.  It had to “pretty please” ask companies to recall unsafe foods.  Now it has the authority, but Congress did not grant new resources to carry out that authority.

The New York TImes explains the reason for the FDA’s lack of oversight:

Audits of the F.D.A.’s oversight of the nation’s food system routinely find the agency’s efforts wanting, in part, the agency says, because its budget for such activities has long been inadequate. And although the new food safety law gave the agency extra supervisory powers, it is not clear how much it will be able to do, given that House Republicans have proposed cutting its budget for protective measures.

The FDA official in charge of food safety, Michael Taylor, has been discussing the vexing resource question in recent speeches.  He points out that the FDA:

Has a a huge workload. And even though public health officials are working hard, the agency will likely not meet all of its deadlines. On top of the backlog, FDA has no idea what its budget will be for fiscal year 2012.

An agriculture appropriations bill that cleared the House last week would cut food safety programs $87 million below fiscal year 2011.

The current budget situation does paint a challenging picture…a patchwork of continuing resolutions to keep the government funded — as we saw in 2011 — makes it nearly impossible to plan ahead.

When Congress gives us our budget over half way through the fiscal year it’s very difficult to use that money in as orderly a way as possible. You can’t use that money to hire the experts you need because the hiring process is such that you won’t get them hired until the end of the fiscal year

When it comes to food safety, we only have one food supply, and it is global.  That was the whole point of my book Pet Food Politics: The Chihuahua in the Coal Mine—a case study of how melamine in China got into American, Canadian, and South African pet foods.  If it could happen to pet food, it could happen to ours.

To monitor the safety of imported foods, the FDA neeeds to be stronger, not weaker.

German authorities now say that  sprouts grown on an organic farm in Lower Saxony are the source of their E. coli O104:H4 outbreak, now responsible for more than 30 deaths and 3,000 illnesses, 750 of them severe kidney disease.

The epidemiological studies point to sprouts after all.

Sprouts, as I mentioned in an earlier post, are a prime suspect in microbial outbreaks.   They have been implicated in many outbreaks in the United States.  This is because sprouts are sprouted from minute seeds that are hard to clean, as shown in this microscopic view:

As Food Safety News explains in a long discussion of this problem, the seeds need to be dumped in bleach to kill bacteria.  It’s also a really good idea to test the wash water to make sure it is free of pathogens.

The seeds are sprouted in water at room temperature, “a warm, moist climate — just perfect for a bacteria’s social life and subsequent reproduction.”

The FDA has been aware of this problem for a long time, as shown by this brief chronology:

• 1999: The FDA issued “nonbinding guidance” on growing sprouts.  This caused the ever-vigilant Center for Science in the Public Interest (CSPI) to file a petition arguing that guidance rules for sprouts needed to be mandatory.
• 2004: The FDA wrote a “note” to producers and shippers of sprouts stating that it was aware of 27 outbreaks of microbial illness due to sprouts and urging producers to follow the voluntary guidance procedures.
• 2004: The FDA followed up by issuing safety guidance for growing sprouts in retail establishments.  These were voluntary, of course.
• 2004: California health officials produced a slide presentation on the hazards of sprout production, urging producers to follow safety guidelines.
• 2005: The FDA announced public meeting to discuss the science of safe production of sprouts as a basis for beginning a rulemaking process for mandatory safety procedures.
• 2009: The FDA issued a warning about consuming alfalfa sprouts.

The Food Safety Modernization act passed last year finally gives FDA the authority to require food safety controls for sprouts.

The German outbreak ought to be a wakeup call for this industry in the United States.  Sellers of bean sprouts market them as health foods but say little about how unsafe they are if eaten raw.

It also ought to be a wakeup call for consumers.  If you aren’t absolutely sure the seeds come from a clean source, cook your sprouts.

I haven’t said anything about the E. coli 0104 crisis in Germany up to now because I’ve been waiting for the evidence.  Without evidence, the source of the outbreak remains uncertain.

Yesterday, the German minister of agriculture announced that sprouts are the cause.  But are they?

What  is known without question is that the outbreak is deadly serious.  Bill Marler reports these shocking numbers as of June 5:

Deaths = 22 (21 in Germany, 1 in Sweden)

Illnesses = 2,243 (2,153 in Germany, and 90 more in 10 other European nations and the U.S.)

Cases of Hemolytic Uremia Syndrome (HUS) = 627

Why shocking?  This is a devastating disease, excruciatingly painful, with a high probability of causing lifelong complications.  And the disease is almost entirely preventable by following standard food safety procedures.

The idea that the cause is sprouts, and German sprouts at that, comes as a surprise.  Why?  First, sprouts are a frequent cause of foodborne illness and should have been high on the list of suspected foods.  Second, sprouts did not turn up in the case-control studies.

Instead, investigators examined cucumbers, lettuce, and tomatoes (and, in the process, put Spanish cucumber producers out of business).  As Marler explains, the German authorities didn’t want to take a chance, given the results of their investigation.

The case-control investigation was conducted by the Robert Koch Institute, the German equivalent of our CDC.

• The cases: From May 29 to June 2, investigators interviewed 46 affected patients from Bremen, Hamburg and Lübeck about the foods they had eaten.
• The controls: They interviewed 2,100 people who were not sick but were of similar age group, sex and region of residence.
• The results:

Food Reported Eaten         % By Cases     % By Controls

Lettuce                                        84                           47

Cucumbers                                 75                           50

Tomatoes                                   80                            63

95% of the Cases had eaten at least one of the three vegetables.

This evidence strongly implicates these vegetables.  But did they not look for sprouts?

In another related study of people from a Frankfurt business company who had become ill, those who had eaten from the salad bar in the company cafeteria had a 7-fold increased risk of developing bloody diarrhea than those who had not.  No such association was seen for other foods investigated, such as dessert, fruit and asparagus.  Sprouts are not mentioned.  How come?

In trying to figure out what’s going on here, a BBC World News report raises even more questions (my emphasis):

The agriculture minister for Lower Saxony, Gert Lindemann, said there was a clear trail of evidence pointing to a plant nursery south of Hamburg [as the source of the contaminated sprouts].

The nursery has been closed, though officials say the outbreak’s source cannot yet be definitively confirmed.

…Mr Lindemann said epidemiological studies all seemed to point to the plant nursery in Uelzen in the state of Lower Saxony, about 100km (62m) south of Hamburg – though official tests had not yet shown the presence of the bacteria there.

“Further evidence has emerged which points to a plant nursery in Uelzen as the source of the EHEC cases, or at least one of the sources,” he said.  [What evidence?]

…Gert Hahne, a spokesman for the Lower Saxony agriculture ministry, earlier told the Associated Press news agency that many restaurants in which people ate before becoming ill had recently taken delivery of the sprouts. [Guilt by association]

He said authorities would still maintain a warning against eating tomatoes, cucumbers or lettuce.

The health ministry in Berlin said it was still waiting for results from tests on the beansprouts, Germany’s DPA news agency reported.

And the head of the Robert Koch Institute (RKI), Germany’s national disease centre, was also reported as saying that the cause of the outbreak could not yet be confirmed.

So: are sprouts the cause?

By this time, the outbreak is slowing down as the contaminated foods make their way through the food supply.

Could this happen here?  You bet.

If ever there was a time to give the FDA more resources, now is it.  The FDA now has the authority to impose standard food safety procedures on food producers and to require safety measures for the foods we import.   But Congress wants to cut the agency’s budget, and badly.

Now would be a good time to let congressional representatives know that we need a stronger FDA.   And while you are at it, let the USDA know that you think it would be a good idea to regulate other forms of toxic E. coli as adulterants in the same way they regulate E. coli 0157:H7. There is plenty government could do right now to protect us from outbreaks like this one.

A word about sprouts:

How come sprouts are such frequent sources of food safety problems?

Sprouts are grown from tiny seeds that are impossible to wash thoroughly enough to ensure that they are free of harmful bacteria.  The seeds are sprouted in water that must be changed several times a day.  This water is an excellent growth medium for bacteria.  That is why FDA guidance says sprout producers ought to test the wash water for harmful bacteria.

Under the new legislation, the FDA has the authority to enforce this guidance.  But does it have adequate personnel?  Unlikely, given the current stance in Congress.

This just in:  No, it’s not sprouts, according to this bulletin from Food Chemical News:

The latest news, reported this morning by both the Associated Press and BBC, is that 23 of 40 samples of organic sprouts taken from the Gaetnerhof farm in the Lower Saxony region of Germany have tested negative for the bacteria. Tests on the other samples have yet to be returned.

Michael Taylor, FDA’s associate commissioner for foods, gave a major speech yesterday at the George Washington University School of Public Health.

In it, he talked about the origin and effectiveness of HACCP (Hazard Analysis and Critical Control Point) controls for preventing food safety problems.  HACCP, he explained, works just like other aspects of public health practice.  It requires:

• understanding the specific food safety hazards that could affect a particular food production operation,

• devising and implementing scientifically validated controls to minimize the hazards,

• monitoring the implementation of preventive controls to verify effectiveness, and

• making corrections and adjustments as needed, based on experience.

He then went on to say how FDA plans to put the Food Safety Modernization Act into action:

We are well on our way to developing a proposed produce safety rule that addresses areas such as employee hygiene, water quality, soil amendments, and animals in the growing area, as FSMA mandates.

In food facilities, such as processing and packaging plants, we will be proposing rules that are grounded in the widely embraced principles of preventive process control for food safety, similar to HACCP.

The law requires each facility to… (1) evaluate the hazards that could affect food safety, (2) specify what preventive steps, or controls, to put in place to minimize or prevent these hazards, (3) specify how the facility will monitor these controls to ensure they are working, (4) maintain routine records of monitoring, and (5) specify what actions the facility will take to correct problems that arise.

For example, in a facility that produces peanut butter, factors such as  ingredient safety, sanitation, and cross contamination would have to be considered. After the outbreak of Salmonella typhimurium in peanut butter in 2008 and 2009, which caused 714 cases of illness, the company had to reevaluate the hazards in its facilities so this wouldn’t happen again.

Such review and correction – and a sharp focus on specific hazards – will become the norm under a system of preventive controls.

Taylor outlined FDA’s vision for preventive controls from farm to table.  Now, if Congress will just give it the resources to do all this, we might actually have a food safety system that functions.