Food Poison Journal - Food poisoning outbreaks and litigation: surveillance and analysis

Contaminated well water from a resort near Hebgen Lake (near West Yellowstone, Montana) is being blamed for the stomach and intestinal maladies plaguing more than 80 people, public health officials said Friday. The Montana Department of Public Health and Human Services has confirmed 14 cases of campylobacter illness, a common GI ailment that can cause diarrhea, cramping, abdominal pain and fever.  At least 70 more cases are probably caused by the same bacteria, the officials said.

"(Campylobacter) is one of the most common, if not the most common, gastrointestinal illnesses in the U.S.," said Matt Kelley, health officer for the Gallatin City-County Health Department. "What was unusual about this one was we were seeing over a dozen, maybe two-dozen cases (last) Thursday and Friday."

Officials think contaminated water from one of two wells at the Campfire Lodge Resort, located outside West Yellowstone, is to blame. The suspect well has been shut off, and the resort's restaurant has been closed, Kelley said, and a boil water order has been issued.

An excellent piece authored by Dennis G. Maki, MD. discussing food safety and seeking lessons learned in recent national Salmonella outbreaks was recently brought to my attention.  Dr. Maki's piece from the March 2009 New England Journal of Medicine looked back over two outbreaks in particular, the 2008 Salmonella Saintpaul outbreak linked to peppers, and the 2009 Salmonella Typhimurium outbreak in PCA peanut butter products. 

Dr. Maki pointed to an important lesson from the Salmonella Saintpaul outbreak- the importance to both consumers and industry alike of good traceability:

Initial epidemiologic investigations by state health departments and the CDC suggested that contamination of tomatoes grown in the southwestern United States was the cause, although this was never proved microbiologically. Predictably, tomato consumption plummeted, and the industry lost an estimated $200 million. After several months of investigation, the outbreak strain was isolated from jalapeño and serrano peppers that had been grown on one Mexican farm.

With respect to the PCA outbreak, Dr. Maki focused on the well-publicized, yet still remarkable, alleged failures of the producer:

Investigations have revealed that salmonella had been isolated from the implicated company's peanut butter or peanut paste in its internal quality-control sampling program on at least 12 occasions during the past year, but no action was taken to investigate the source of contamination, review sterilization procedures, or reclean the production machinery. The company is now under criminal investigation.

Both of these outbreaks involved staggering amounts of confirmed illnesses - over 1400 with the peppers, over 600 connected to peanut butter.  The article points out though, as we have here, that the total number of ill individuals was likely much larger. "It has been estimated that in large salmonella outbreaks, for every case identified by clinical culture, there are approximately 38 additional undetected cases — meaning that these two outbreaks may each have affected more than 20,000 persons."

The article did provide a number of recommendations aimed at stemming the tide of ongoing large scale illness outbreaks tied to commercial food.

A first step was the improved design and implementation of HACCP (Hazard Analysis, and Critical Control Point)  programs by food producers.   Dr. Maki also called for a nationwide expansion of FoodNet, a food safety surveillance program.  He also recommended speeding up the reaction time of the CDC's PulseNet's program.  This program finds genetic links between reported illnesses, and is key to identifying an implicated food product.  

Dr. Maki also called for improved monitoring by the FDA and USDA.  This step is long overdue, and has been called for here and by Mr. Marler. 

The article also called for an "international moratorium on the incorporation into animal feeds of growth-promoting antibiotics, which have been linked to greatly increased antimicrobial resistance in bacterial enteropathogens."

Dr. Maki's plea concluded with a call for increased reliance of irradiation of food.  The article is an excellent overview of the challenges facing our food production and distribution system, and an insightful look at much needed improvements.

More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration’s new electronic portal in its first months of operation, the agency said today.

Mandated by Congress, the Reportable Food Registry (the Registry) is a new system that requires manufacturers, processors, packers and distributors to immediately report to the government safety problems with food and animal feed, including pet food, that are likely to result in serious health consequences.

“The FDA’s new reporting system has already proven itself an invaluable tool to help prevent contaminated food from reaching the public,” said FDA Deputy Commissioner for Foods Michael R. Taylor.

A report summarizing the Registry’s first seven months of operation (September 2009 -March 2010) finds that it logged 125 primary reports – initial reports about a safety concern with a food or animal feed (including food ingredients) – and 1,638 subsequent reports from suppliers or recipients of a food or feed for which a primary report had been submitted, from both domestic and foreign sources. These reports help FDA and the food industry locate hazardous foods in the supply chain and prevent them from reaching consumers.

Two notable reports first identified through the Registry prompted the following:

*  A February 2010 recall of hydrolyzed vegetable protein (HVP), without any report of illness. More than 1,000 industry reports specifically for products containing HVP, resulted in the removal of 177 products from commerce.

*  A November 2009 recall of products containing sulfites but not labeled as such. More than 100 reports regarding the inadvertent use of an ingredient containing sulfites in two nationally distributed prepared side dishes that were not labeled as containing sulfites resulted in their removal without any reports of illness.

Among the 125 primary reports, Salmonella accounted for 37 percent of hazards, undeclared allergens or intolerances accounted for 35 percent, and Listeria monocytogenes accounted for 13 percent. Among the 11 different commodity categories involved were: 14 animal feed or pet food, 12 seafood, 11 spices and seasonings, and 10 dairy products. Because the Registry has been operational for only a short period, it is too early to draw inferences concerning patterns of food and feed adulteration.

“Industry is increasingly detecting contamination incidents through its own testing, and FDA access to this information permits us to better target our inspection resources and verify that appropriate corrective measures have been taken,” Taylor said. “Ensuring that the American food supply is safe is a top priority of the FDA, and the Reportable Food Registry strengthens our ability to help prevent foodborne illness.”

Under legislation enacted in 2007 that created the Registry, industry must report foods or feeds that present a reasonable probability of serious adverse health consequences or death to humans or animals to the FDA within 24 hours. The law does not apply to infant formula or dietary supplements, which are covered by other mandatory reporting systems. The Registry does not receive reports about drugs or other medical products, reports about products under the exclusive jurisdiction of the U.S. Department of Agriculture, or reports from consumers.

Steve Mills, a reporter with the Chicago Tribune and frequent contributor to the national food safety dialogue, wrote an excellent analysis of post-recall risks to consumer health for today's edition of the Tribune.  The problem:  equal parts stores not getting recalled products off of shelves, manufacturers not being able to retrieve recalled product, and consumers not getting word that a product has been recalled. 

In addition to the ConAgra pot pie Salmonella outbreak in 2007, Mills highlights several major outbreaks and/or recalls that have occurred in the last several years:

In 2009, for instance, when the U.S. Department of Agriculture was involved in 59 recalls in which the amount of food sought and recovered was known, 56 came up short of the amount they identified as potentially tainted or produced at a time when factory controls were lax.

Two of those efforts highlight how far short recalls can fall. Last July a Denver processor announced a recall of more than 460,000 pounds of ground beef tied to a salmonella outbreak but recovered only 119,000 pounds. In October a New York processor announced a recall of 545,000 pounds of ground beef tied to an outbreak of E. coli; it recovered 795 pounds, according to the USDA.With today's global distribution, this is a problem

To put a finer point on it, in the 2007 ConAgra pot pie salmonella outbreak that ultimately sickened over 400 people with confirmed illnesses, the CDC found that many, many people became ill after the recall was announced.  Here is a chart that shows how many became ill before and after the recall announcement:

Another situation that warrants mention is the 2010 ConAgra (actually, Marie Callendar's brand) cheesy chicken and rice frozen entree Salmonella outbreak and recall.  In a June 2010 press release, the Oregon Department of Health announced concern that retailers had not yet removed all recalled product from store shelves.  The statement read:

Public health officials repeated today that an outbreak of salmonellosis has been linked to a boxed frozen entrée product manufactured by ConAgra Foods, Inc. under the Marie Callender label. The Cheesy Chicken & Rice item has been identified as the likely source of the outbreak, which has sickened at least 30 people in 15 states. Health officials worry that the entrée has not have been removed from grocery store shelves. Consumers may also still have the product in their freezers.

“We’re concerned that people and some retailers may not have gotten this information,” said Emilio DeBess, a senior epidemiologist at the Oregon Public Health Division. “This product was sold at grocery stores throughout Oregon and elsewhere. Consumers who have any of the Cheesy Chicken & Rice entrées in their home freezers need to throw them out or return them to the store. Retailers that have this product in their stores need to get them out of circulation immediately.

"Oregon Department of Agriculture inspectors checked in a number of stores on Tuesday and found the recalled product still available in a limited number of stores," DeBess added. "To protect consumers, store managers need to be vigilant about responding to recall notices."

As with many problems that we currently face in our food supply, this one is particularly potent in large part because of the nature of our production and distribution systems.  But despite the wider audience for these problems due to books like The Omnivore's Dilemma and movies like Food, Inc., it's a problem that's not going away.  Bottom line is that manufacturers and retailers need to improve traceability and their dedication to the public health measure of actually making sure that information about recalls actually reaches consumers. 

Moreover, this is a discussion that is not only long overdue (see 2007 ConAgra pot pie outbreak), but has been raised multiple times before.  Phyllis Entis, at effoodalert.com recently made several recommendations to address the problem:

1.  Provide a retail distribution list for all recalls. The list should include food service outlets, restaurants, cafés, and institutional kitchens – not just retail stores.

2.  Require retail stores to post a prominent recall notice on the store shelf or refrigerator/freezer where the recalled product is typically displayed. This is already done in some countries, including the United Kingdom.

3.  Fine retailers who ignore recall notices and neglect to remove recalled products from sale. This has been done in Australia.

4.  Post on FDA and USDA web sites in a timely fashion the reports for all inspections during which "significant violations" or "significant deviations" were noted (FDA does this selectively, based on its perception of the public's interest in the results of specific inspections).

5.  Post on FDA and USDA web sites in a timely fashion all Warning Letters and other enforcement actions taken (FDA posts Warning Letters, although not always timely).

I would also add a report back requirement for retailers--i.e. that the retailer must report back to (agency/recalling company) within a certain number of days of receiving notice of a recall through dedicated channels, plus fines for each day that the retailer does not report back as required.  Something for the FDA to consider when the Food Safety Modernization Act is finally passed. 

EVERY day, about 200,000 Americans are sickened by contaminated food. Every year, about 325,000 are hospitalized by a food-borne illness. And the number who are killed annually by something they ate is roughly the same as the number of Americans who’ve been killed in Iraq and Afghanistan since 2003.

Those estimates, from the Centers for Disease Control and Prevention, suggest the scale of the problem. But they fail to convey the human toll. The elderly and people with compromised immune systems face an elevated risk from food-borne pathogens like listeria, campylobacter and salmonella. By far the most vulnerable group, however, are children under the age of 4. Our food will never be perfectly safe — and yet if the Senate fails to pass the food safety legislation now awaiting a vote, tens of thousands of American children will become needlessly and sometimes fatally ill.

Almost one year ago, the House of Representatives passed the Food Safety Enhancement Act with bipartisan support. A similar bill, the F.D.A. Food Safety Modernization Act, was unanimously approved by the Senate Health, Education, Labor and Pensions Committee in November. This legislation would grant the Food and Drug Administration, which has oversight over 80 percent of the nation’s food, the authority to test widely for dangerous pathogens and improve the agency’s ability to trace outbreaks back to their source. Most important, it would finally give the agency the power to order the recall of contaminated foods — and to punish companies that knowingly sell them.

This bill is supported by an unusual set of advocacy groups: the American Public Health Association, Consumers Union, the Center for Science in the Public Interest, the United States Chamber of Commerce and the Grocery Manufacturers Association, among others. Last week, a poll for Consumers Union found that 80 percent of Americans want Congress to empower the F.D.A. to recall tainted foods.

You’d think that a bill with such broad support, on a public health issue of such fundamental importance, would easily reach the floor of the Senate for a vote. But it has been languishing, stuck in some legislative limbo. If it fails to gain passage by the end of this session, Congress will have to start from scratch again next year.

Food processors reluctant to oppose the bill openly will be delighted if it dies a quiet death. That’s because, right now, very few cases of food poisoning are ever actually linked to what the person ate, and companies that sell contaminated products routinely avoid liability. The economic cost is instead imposed on society. And it’s a huge cost. According to a recent study sponsored by the Pew Charitable Trusts, the annual health-related cost of food-borne illness in the United States is about $152 billion.

Without tough food safety rules, a perverse economic incentive guides the marketplace. Adulterated food is cheaper to produce than safe food. Since consumers cannot tell the difference between the two, companies that try to do the right thing are forced to compete with companies that couldn’t care less.

So the law of the jungle prevails, as Upton Sinclair noted more than a century ago. In those days, many companies had no qualms about selling children’s candy colored with lethal heavy metals and rancid food laced with toxic chemicals to disguise the stench; such abuses were widespread. And some of the strongest support for President Theodore Roosevelt’s food safety crusade came from processors (like the H. J. Heinz Company) that were outraged by the unfair advantage their competitors gained by selling cheap, dangerous, adulterated food.

The Pure Food and Drug Act of 1906 helped to eliminate many unsafe practices. But the recent centralization and industrialization of the American food system poses new kinds of threats.

Today, a problem at a single factory can swiftly lead to an outbreak that extends nationwide. Last year’s peanut butter recall illustrates what can go wrong. Executives at the Peanut Corporation of America knew that peanut butter from their filthy, rodent-infested plant was testing positive for salmonella — but shipped it anyway, for months.

Thousands of different products, manufactured by more than 200 companies, including candies and cookies marketed to children, were potentially tainted thanks to that one plant. And in the end, roughly 20,000 Americans got salmonella; about half of them were under the age of 16 and one-fifth were younger than 5.

The enormous rise in imported food also exposes American consumers to food safety lapses overseas. In recent years, China has been responsible for food scandals that bring to mind the United States in the days of Upton Sinclair: Chinese companies have been caught adding lead-based whiteners to pasta and selling beverages made with industrial alcohol. Two years ago, almost 300,000 Chinese infants were sickened by baby formula that had been adulterated with melamine, a cheap but toxic chemical. The overuse of antibiotics and pesticides in Chinese agriculture is rampant.

Despite those food safety problems, China has become the largest exporter of food to the United States after Canada and Mexico. About 60 percent of the apple juice in America — like peanut butter, a product consumed largely by children — now comes from China. This is yet another reason that passage of the F.D.A. modernization act is so urgent; it would, for the first time, subject foods from overseas to the same standards as those produced in the United States.

Last year, President Obama called for measures that would “upgrade our food safety laws for the 21st century,” and this bill is a good first step. The president has asked lawmakers to pass the legislation, saying that it would provide “the federal government with the appropriate tools to accomplish its core food safety goals.”

For months, however, the Internet has been rife with wild rumors and accusations: that the bill is really a subterfuge cleverly designed to eliminate small farms and strengthen the grip of industrial agriculture; that it would outlaw organic production; that it would hand over the nation’s food supply to Monsanto.

Those arguments may be sincere. But the bill very clearly instructs the Food and Drug Administration to focus its enforcement efforts on plants that pose the greatest risk of causing large-scale outbreaks. And the bill’s wording can still be clarified so that mom-and-pop producers aren’t threatened by heavy-handed government regulations.

What the legislation actually seeks is some restraint on unchecked corporate power. We’ve seen what happens when Wall Street is allowed to regulate itself and when the oil industry is allowed to regulate itself. How could it possibly make sense to let the food industry continue to write its own rules?

I’ve come to know families that were devastated by a food-borne illness. A great deal of harm, inflicted on some of the weakest members of society, can be avoided with a few simple reforms. Nobody should lose a child because the Senate lacks the will and the leadership to act.