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

Bovine spongiform encephalopathy (BSE), referred to as "mad cow disease," is a chronic degenerative nervous system disease affecting cattle. The disease was first diagnosed in 1986 in Great Britain. BSE is so named because of the spongy appearance of the brain tissue of infected cattle when sections are examined under a microscope.

Affected animals may display changes in temperament, such as nervousness or aggression, abnormal posture and difficulty in rising, decreased milk production, or loss of body weight despite continued appetite. Affected cattle die or are killed.

The incubation period (the time from when an animal becomes infected until it first shows signs of disease) is from 2 to 8 years. Following the onset of clinical signs, the animal's condition deteriorates until it dies. This process usually takes from 2 weeks to 6 months. 

Currently, there is no test to detect the disease in a live animal; veterinary pathologists confirm BSE by postmortem microscopic examination of brain tissue or by the detection of the abnormal form of the prion protein.

Cyclospora is a parasite composed of one cell, too small to be seen without a microscope. The organism was previously thought to be a blue-green alga or a large form of Cryptosporidium. Cyclospora cayetanensis is the only species of this organism found in humans. The first known human cases of illness caused by Cyclospora infection (that is, cyclosporiasis) were first discovered in 1977. An increase in the number of cases being reported began in the mid-1980s, in part due to the availability of better diagnostic techniques. Over 15,000 cases are estimated to occur each year in the United States. The first outbreak in North America occurred in 1990 from contaminated water. Since then, several outbreaks of cyclosporiasis have been reported in the U.S. and Canada, many associated with eating fresh fruits or vegetables. In some developing countries, cyclosporiasis is common among the population and travelers to those areas have become infected as well.

A half a billion eggs and thousands of illnesses later, both regulators and industry are moving towards increasing food safety protections for egg production.  Phillip Brasher of the Des Moines Register reported today on the two groups' separate plans for increased scrutiny. 

For their part, it appears that egg producers recognize that running an operation the way Wright County Egg was run is bad for business:

Producers "want nothing else to happen like what happened in Iowa," said Howard Magwire, vice president of government relations for the United Egg Producers. The trade group is developing safety standards for the industry that would go beyond federal regulations.

On the regulation side, the Wright County Egg Salmonella enteritidis outbreak was the latest food safety disaster to highlight inadequacies in the U.S. food regulation scheme:

Food safety advocates have criticized the way regulators oversee egg production. The USDA Agricultural Marketing Service, for example, has personnel on site at egg farms to grade eggs and sends inspectors to farms regularly to check for the cleanliness of packing facilities.

But the FDA, while overseeing henhouses, rarely inspected farms because officials said they until July didn't have any standards that producers had to meet. Many states, including Iowa, the largest producer of eggs, conducted no inspections, either.

The failures were not only at the federal level.   Iowa, like many other states, had conducted no hen house inspections.  At least for now, it appears that both industry and regulators are trying to learn from the outbreak:

The United Egg Producers is developing industry standards that will mirror the agency's production rules and go a step further by requiring participating producers to vaccinate all hens against salmonella. Because of contamination that the food agency found in feed at one of the Iowa operations, the producers' group also is considering writing sanitation standards for feed mills, Magwire said.

The FDA is promising more scrutiny as well:.

In the wake of the recall, the FDA announced plans to inspect every major farm in the nation, starting with operations that have had past trouble with government officials, and it is working on coordinating oversight with the USDA. Sixteen inspections had been carried out by midmonth. The agency expects to conduct about 600 inspections in the next 14 months.

A "third" wing of food-safety, third-party audits, continues to present a vexing problem.   Like other companies later found to have major problems, Wright County Egg had undergone third-party audits and received strong grades.  Third-party auditors paid directly by the companies they inspect seem to lack incentive to provide honest feedback.   As of yet, neither egg producers nor government agencies have proposed any improvement. 

Early last summer, at least 8 people were infected by E. coli O157:H7 after consuming raw milk produced at the Hartmann dairy farm in Sibley County.  Environmental and animal samples tested positive for the same strain of E. coli O157:H7 as had infected the outbreak victims.  Minnesota state health officials also, however, collected animal and environmental samples that tested positive for campylobacter and cryptosporidium.  Which leads to today's announcement by Minnesota Department of Health (MDH) that seven people with a recent history of consuming raw milk have been sickened by campylobacter (3 people) and cryptosporidium (4 people). 

MDH states: 

When MDH contacted the individuals to inquire about potential causes of their illnesses (a routine public health practice designed to identify likely causes of illness in order to prevent future illnesses) the ill people reported that they had consumed raw milk. Those who named a source named the Hartmann farm. Laboratory tests found that the Campylobacter bacteria and Cryptosporidium parasites in most of the ill people were genetically identical to organisms found in animal and environmental samples taken on the Hartmann farm this past summer.

Apparently, not all of the campylobacter and cryptosporidium cases in the outbreak were able to name a source for the raw milk that they had consumed.  Nevertheless, MDH seems to conclude that the illnesses all occurred as the result of consuming Hartmann milk.  “We’re concerned that people are continuing to get sick after consuming products from this farm,” said MDH Foodborne Diseases Unit Supervisor Kirk Smith. “We’re also concerned that some people who became ill were given the Hartmann dairy product by friends or neighbors who did not tell them the source.”  Moreover, the fact that the illnesses share the same genetic profile as campylobacter and cryptosporidium test results taken from samples at Hartmann farm this summer strongly supports the conclusion that the present illnesses occurred because of Mike Hartmann's bad milk.

Dr. Smith also noted that, in addition to the illnesses associated with the Hartmann farm, MDH has identified 47 other people since January 1, 2010 who became ill after drinking raw milk from a variety of sources throughout the state; none of these 47 cases was part of an identified outbreak (no two cases reported the same source). Most of the individual cases have been in children or young adults.

“While we are very concerned about the ongoing illnesses associated with this one farm, this isn’t just about one farm selling raw milk and making people sick,” Smith said. “This also is about the inherent risk of any raw milk. People need to think carefully about those risks before consuming raw dairy products from any source, and people need to know that the risks are especially high for young children.” 
 

The Facts:

On October 21, 2010, the US Government filed a complaint for forfeiture in rem (meaning, a legal action to seize and condemn violative products) of raw milk-based cheese products manufactured by Estrella Family Creamery in Montesano, Washington. The government's complaint identifies Estrella cheese products as having the potential to be contaminated by Listeria monocytogenes, a bacteria that can cause severe illness in human beings, including death in unborn children, the elderly, or people with compromised immune systems.  Finally, the government's complaint was filed only after the FDA requested that Estrella recall all of its cheese products, which Estrella declined to do.

Post complaint is where the facts end and opinions and rhetoric begin.  Some comments are important, in some senses, and obviously true, like that the Estrellas are good people who do not want or intend their products to cause illness or death, which would be both bad for business and contrary to the principles by which the Estrella family obviously live their lives.  Many other comments from various corners, including the Estrellas themselves, are totally Irrelevant and only serve to perpetuate the view that certain raw milk devotees, including many producers whose products have sickened and killed people, can't see the forest for the trees.  We are only a few months removed from the Hartmann debacle, where a Minnesota raw milk farmer fought the good fight, in his view, against indisputable evidence gathered by arguably the most competent health agency in the world.  These attempts to control the moral and scientific high-ground are as pathetic, in the face of competently gathered evidence, as they are, ultimately, totally misguided and wrong. 

So where is the reason in the debate over the current raw milk-based debacle in Montesano?  One place it doesn't seem to be is in all the post-complaint rhetoric.  Neither God, nor guns, nor local versus monolithic agriculture really matter at all.  Each producer of food must be judged only by the quality of his products.

Again, The Facts:

The affidavit (see full affidavit below) filed in support of the government's complaint against Estrella states that, in February and March 2010, listeria monocytogenes was isolated from finished cheese samples, salt brine used in the production process, and "throughout the production and storage areas."  On August 2, the FDA lab isolated listeria monocytogenes from processing and aging rooms at Estrella, including one room where cheese was being actively cut and wrapped for sale to consumers.  On August 16, a sample of "Caldwell Crick Chevrette" tested positive for listeria monocytogenes.  Notably, the August 16 positive test was generated from cheese produced on April 27, and was ready for sale and consumption in August.  Finally, FDA's PFGE analysis showed that the February and August samples contained identical strains of listeria monocytogenes.

The gist of the evidence is that Estrella had a problem that went uncorrected and thus posed a continuing threat to consumer health.  This was not a facility that produces a product with a very finite shelf life.  Some cheeses are aged for two months, and some, evidently, for up to six months.  Notably, we are only a little more than two months removed from the last positive test in Estrella products and, again notably, the August and February tests were positive for an identical strain of listeria monocytogenes.  Estrella had a problem in its production processes that it did not, or could not, control.

In this situation, reason lies only in the facts.  The FDA has a public health mandate, and it must act to protect the public health (whether it does so indiscriminately is another matter altogether).  Fortunately for Estrella, it is now in an adversarial process where it will have the opportunity, in court, to prove that seizure and forfeiture of its products is unwarranted, and that the government is, in fact, incorrect.