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Food Poison Journal

Food Poisoning Outbreaks and Litigation: Surveillance and Analysis

What is Cyclospora cayetanensis? Is that Feces in my Cilantro?

Screen shot 2010-10-30 at 10_13_31 PMCyclospora 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.

Where does Cyclospora come from?

Cyclospora is spread by people ingesting water or food contaminated with infected stool. For example, exposure to contaminated water among farm workers may have been the original source in raspberry-associated outbreaks in North America.

Cyclospora needs time (one to several weeks) after being passed in a bowel movement to become infectious. Therefore, it is unlikely that Cyclospora is passed directly from one person to another. It is not known whether or not animals can be infected and pass infection to people.

What are the typical symptoms of Cyclospora infection?

Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, bloating, increased gas, stomach cramps, loss of appetite, nausea, low-grade fever, and fatigue. In some cases, vomiting, explosive diarrhea, muscle aches, and substantial weight loss can occur. Some people who are infected with Cyclospora do not have any symptoms. The time between becoming infected and becoming ill is usually about one week. If not treated, the illness may last from a few days up to six weeks. Symptoms also may recur one or more times (relapse). In addition, people who have previously been infected with Cyclospora can become infected again.

What are the serious and long-term risks of Cyclospora infection?

Cyclospora has been associated with a variety of chronic complications such as Guillain-Barre syndrome, reactive arthritis or Reiter’s syndrome, biliary disease, and acalculous cholecystitis. Since Cyclospora infections tend to respond to the appropriate treatment, complications are more likely to occur in individuals who are not treated or not treated promptly. Extraintestinal infection also appears to occur more commonly in individuals with a compromised immune system.

How is Cyclospora infection detected?

Your health care provider will ask you to submit stool specimens to see if you are infected. Because testing for Cyclospora infection can be difficult, you may be asked to submit several stool specimens over several days. Identification of this parasite in stool requires special laboratory tests that are not routinely done. Therefore, your health care provider should specifically request testing for Cyclospora if it is suspected. Your health care provider might have your stool checked for other organisms that can cause similar symptoms.

How is Cyclospora infection treated?

The recommended treatment for infection with Cyclospora is a combination of two antibiotics, trimethoprim-sulfamethoxazole, also known as Bactrim, Septra, or Cotrim. People who have diarrhea should rest and drink plenty of fluids. No alternative drugs have been identified yet for people with Cyclospora infection who are unable to take sulfa drugs. Some experimental studies, however, have suggested that ciprofloxacin or nitazoxanide may be effective, although to a lesser degree than trimethoprim-sulfamethoxazole. See your health care provider to discuss alternative treatment options.

How can Cyclospora infection be prevented?

Avoiding water or food that may be contaminated is advisable when traveling. Drinking bottled or boiled water and avoiding fresh ready-to-eat produce should help to reduce the risk of infection in regions with high rates of infection. Improving sanitary conditions in developing regions with poor environmental and economic conditions is likely to help to reduce exposure.

Washing fresh fruits and vegetables at home may help to remove some of the organisms, but Cyclospora may remain on produce even after washing.

Cyclospora Cilantro from Mexico Sickens Hundreds in US

cilantroThe Centers for Disease Control and Prevention (CDC) and state public health officials have identified annually recurring outbreaks (in 2012, 2013, and 2014) of cyclosporiasis in the United States, which have been associated with fresh cilantro from the state of Puebla, Mexico. There is currently (in July 2015) another ongoing outbreak of cyclosporiasis in the United States in which both the Texas Department of State Health Services and the Wisconsin Department of Health Services and the Wisconsin Department of Agriculture, Trade and Consumer Protection have identified cilantro from the Mexican state of Puebla as a suspect vehicle with respect to separate illness clusters.

Texas DSHS has received reports of 205 Cyclosporiasis cases from around Texas this year, prompting an investigation into the infections in hopes of determining a common source. People who have a diarrheal illness lasting more than a few days or diarrhea accompanied by a severe loss of appetite or severe fatigue should contact their health care provider.

Past outbreaks have been associated with cilantro from the Puebla area of Mexico. While the investigation into the current outbreak is ongoing, imported cilantro has been identified as a possible source of some infections. The U.S. Food and Drug Administration recently issued an import alert detaining cilantro from that area coming into the U.S.

DSHS recommends thoroughly washing fresh produce, but that may not entirely eliminate the risk because Cyclospora can be difficult to wash off. Cooking will kill the parasite.

Cyclospora cayetanensis is a human-specific protozoan parasite that causes a prolonged and severe diarrheal illness known as cyclosporiasis. In order to become infectious, the organism requires a period outside of its host. Illnesses are known to be seasonal and the parasite is not known to be endemic to the United States. Cyclosporiasis occurs in many countries, but it seems to be most common in tropical and subtropical regions. People become infected with C. cayetanensis by ingesting sporulated oocysts, which are the infective form of the parasite. This most commonly occurs when food or water contaminated with feces is consumed. An infected person sheds unsporulated (immature, non-infective) C. cayetanenis oocysts in the feces.

Based on epidemiological evidence collected by affected domestic states, the CDC and traceback evaluations conducted by FDA, cilantro from the state of Puebla, Mexico was implicated as the vehicle for some of the U.S. cyclosporiasis infections in 2013 and 2014. In addition, after cyclosporiasis illnesses from the 2013 outbreak were linked to cilantro from Puebla, FDA reviewed a cluster of cyclosporiasis illnesses from 2012 in which the state of Texas had previously identified cilantro as one of multiple possible suspect vehicles and determined that cilantro from the state of Puebla, MX was supplied to the point of service implicated in that outbreak. While this means that cilantro from the state of Puebla, MX was one potential source of the 2012 outbreak, this was not confirmed by epidemiological means. The Texas Department of State Health Services has also identified cilantro from the state of Puebla as a suspect vehicle in an ongoing outbreak (as of May 2015). Additionally, in the 2015 outbreak Wisconsin officials have identified cilantro from the state of Puebla, MX as a suspect vehicle for a cluster of illnesses associated with a single restaurant. The source(s) of the 2015 outbreak(s) are still under investigation.

FDA believes it is extremely unlikely that these outbreaks of cyclosporiasis are due to isolated contamination events because of their recurring nature, both in the timing with which they occur (typically April August each year) and the repeated association of illnesses with cilantro from the state of Puebla. No single supplier (including retail outlets or distribution centers), packing date, shipping date, or lot code can explain all the illnesses. FDA believes the source of C. cayetanensis contamination is likely attributable to a broader source of contamination. Sources of contamination may include fecal contamination of growing areas, irrigation of fields with water contaminated with sewage, cleaning or cooling produce with contaminated water, and/or poor hygienic practices of workers that harvest and process the produce, and lack of adequate cleaning and sanitizing of equipment that comes in contact with the product.

FDA and the Mexican regulatory authorities for farms, packing houses and processors in Mexico, Servicio Nacional de Sanidad, Inocuida y Calidad Agroalimentaria (SENASICA) and the Comisin Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS), investigated farms and packing houses in Mexico, including in the state of Puebla, to ascertain the conditions and practices that may have resulted in the contamination of cilantro. From 2013 to 2015, FDA, SENASICA, and COFEPRIS inspected 11 farms and packing houses that produce cilantro in the state of Puebla, 5 of them linked to the US C. cayetanensis illnesses, and observed objectionable conditions at 8 of them, including all five of the firms linked through traceback to the U.S. illnesses. Conditions observed at multiple such firms in the state of Puebla included human feces and toilet paper found in growing fields and around facilities; inadequately maintained and supplied toilet and hand washing facilities (no soap, no toilet paper, no running water, no paper towels) or a complete lack of toilet and hand washing facilities; food-contact surfaces (such as plastic crates used to transport cilantro or tables where cilantro was cut and bundled) visibly dirty and not washed; and water used for purposes such as washing cilantro vulnerable to contamination from sewage/septic systems. In addition, at one such firm, water in a holding tank used to provide water to employees to wash their hands at the bathrooms was found to be positive for C. cayetanensis. Based on those joint investigations, FDA considers that the most likely routes of contamination of fresh cilantro are contact with the parasite shed from the intestinal tract of humans affecting the growing fields, harvesting, processing or packing activities or contamination with the parasite through contaminated irrigation water, contaminated crop protectant sprays, or contaminated wash waters.

The outbreak investigations repeatedly associating cilantro from the state of Puebla, MX with U.S. cyclosporiasis illnesses, and the repeatedly observed insanitary conditions providing likely routes of contamination for C. cayetanensis at multiple firms producing cilantro in the state of Puebla, MX, lead FDA to conclude that cilantro imported from the state of Puebla, Mexico appears to be adulterated under Section 402(a)(4) of the Act because it appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. It is therefore subject to refusal of admission under Section 801(a)(3) of the Act. In addition, the cilantro appears to have been manufactured, processed, or packed under insanitary conditions within the meaning of Section 801(a)(1) of the Act. The seasonality of the previous C. cayetanensis outbreaks warrants detaining cilantro from the state of Puebla, Mexico during April 1 through August 31 of every year.

In Peanut Food Poisoning Case, Punishment Doesn’t Fit the Crime

A very interesting perspective on “food crimes.”  We need to have a broad discussion on how regulation, civil and criminal litigation can make our food supplier safer.  With respect to whether a food executive would not recall a product because it could put him or her in jail – I think the opposite is true.  Although, most recalls are “voluntary” – they are not really – once a product is found to be adulterated, there really is nothing voluntary about recalling the product.  I submit the executive would be in far greater hot water if the product was not recalled and it caused harm.

In Peanut Food Poisoning Case, Punishment Doesn’t Fit the Crime
Jenna Greene, The Litigation Daily
July 26, 2015

business-man-in-handcuffs-300x205It’s hard to feel sorry for Stewart Parnell.

The former owner and CEO of Peanut Corporation of America and his brother Michael, a peanut broker, were convicted last year of multiple counts of conspiracy and fraud for selling peanut-based products tainted with salmonella.

Thousands of people in 46 states were sickened-the kind of sick where, as one plaintiff described it, her bowel movements were pure blood. Nine people died.

According to federal prosecutors, the Parnells “knew that salmonella could cause great harm, knew that their products tested positive for salmonella, and knew that they were selling those products anyway, all the while lying to their customers about the safety of those products.”

The question is, what’s the appropriate punishment?

In a July 22 court filing, Justice Department lawyers said that based on federal sentencing guidelines, Stewart Parnell should get life in prison, Michael Parnell should serve 17.5 to 21.8 years and Mary Wilkerson, the quality assurance manager at the company’s peanut processing plant in Blakely, Ga., should get 8 to 10 years.

Such lengthy sentences are without precedent for food safety violations, which are rarely subject to criminal prosecution. But perversely, the punishment may have a detrimental effect on food safety. That’s because the length of the sentence is tied to the amount of money lost in the fraud-in this case, a recall covering 3,918 peanut products. It resulted in $144 million in direct losses and more than $1 billion in lost sales.

For example, the company was one of three peanut paste suppliers for Kellogg Co., for use in products like Keebler peanut butter sandwich crackers and Famous Amos peanut butter cookies. Peanut Corp. falsely told Kellogg that its paste had been microbiologically tested and determined to be safe.

Kellogg then inter-mingled the peanut paste from all of its suppliers, according to E. Scott Austin, a partner at Gentry Locke Rakes & Moore who represents Stewart Parnell, ballooning the size of the recall. Austin argues that sentencing guideline calculations don’t fit a case like this. “When you have hundreds of millions of dollars lost through a food recall, that makes any food recall potentially a life sentence in prison,” he said.

The result: food executives will be afraid to issue broad-based voluntary recalls-and virtually all recalls are voluntary-if it means they could spend the rest of their lives in jail. It’s an outcome that doesn’t seem likely to lead to safer food, even if it sends an unequivocal message that food safety matters.

Sentencing is set for Sept. 21 before U.S. District Judge W. Louis Sands in the Middle District of Georgia.

The case also underscores how idiosyncratic criminal prosecutions are for food safety violations. That there are civil consequences for food poisoning is all but certain-plaintiffs lawyers like William Marler of Marler Clark in Seattle see to that.

Indeed, Marler filed 41 lawsuits against Peanut Corp. on behalf of salmonella victims. In 2010, U.S. Magistrate Judge Michael Urbanski in Lynchburg, Va. awarded victims $12.75 million, payable from the company’s insurance policy.

Marler notes that federal prosecutors are inconsistent about seeking criminal penalties under the Federal Food, Drug and Cosmetic Act. Because there was evidence that the Parnells knew their products were probably contaminated, the charges against them were not so surprising.

But in other instances, Marler said it’s hard to tell why some food producers, like the Jensen brothers, whose cantaloupe was tainted with listeria, were prosecuted, but the family members who own Bidart Bros., linked to listeria in caramel apples, were not-or at least not yet.

“If you’re going to prosecute some, you damn well ought to prosecute others who are similarly situated,” Marler said. “Otherwise, it undercuts the rule of law.”

Brain Eating Amoeba Found in Louisiana Drinking Water

Naegleria+fowleriLate Wednesday, the Louisiana Department of Health and Hospitals (DHH) confirmed the presence of the Naegleria fowleri amoeba in the St. Bernard Parish Water System at the site of a leaking sampling station. The water system, which serves 44,000 residents in St. Bernard Parish, was tested by DHH as part of the State’s new public drinking water surveillance program. DHH notified the water system and local officials Wednesday evening. The Department asked the water system to conduct a 60-day chlorine burn to ensure that any remaining amoeba in the system are eliminated. Parish President Dave Peralta confirmed that the system would conduct the burn out of an abundance of caution.

Based on current monthly chloramine residual compliance reports, the water system has met the requirements with Louisiana rules for chloramine disinfectant levels set forth by the 2013 by emergency rule and additional requirements in 2014 by the Louisiana Legislature. Five other sites on the system tested negative for the amoeba and one site did not meet the required level of disinfectant.

Tap water in St. Bernard Parish is safe for residents to drink, but the Department urges residents to avoid getting water in their noses. Naegleria fowleri is an amoeba that occurs naturally in freshwater.

As Naegleria fowleri infections are extremely rare, testing for this amoeba in public drinking water is still relatively new and evolving. Fewer than 10 deaths in the United States have been traced back to the amoeba, with three occurring in Louisiana over the last several years. The amoeba was identified in St. Bernard Parish Water System in the summer of 2013; the U.S. Centers for Disease Control and Prevention (CDC) confirmed that the system no longer tested positive for the presence of the amoeba in February 2014.

DHH conducts sampling of public drinking water systems for Naegleria fowleri each summer when temperatures rise. So far, DHH has tested 12 other systems for the amoeba and still awaiting lab results for each.

Naegleria fowleri causes a disease called primary amebic meningoencephalitis (PAM), which is a brain infection that leads to the destruction of brain tissue. In its early stages, symptoms of PAM may be similar to bacterial meningitis.

DHH Safe Drinking Water Program staff sampled seven sites along the St. Bernard Parish Water System. Two of the seven sites tested positive for the amoeba. One positive test was at a site at the water treatment plant before the water was treated. The second positive test occurred at 948 Angela Street, which may have been contaminated by ground water due to a leak at the sampling station. Chlorine levels at the site of the positive sample did meet the 0.5 mg/l requirement. The Department will continue to consult with the water system and the CDC. The Department requested that the water system conduct a 60-day free chlorine burn in the water system. The chlorine burn will help reduce biofilm, or organic buildup, throughout the water system and will kill the amoeba. The parish has agreed to conduct this precautionary measure.

Precautionary Measures for Families:

According to the CDC, every resident can take simple steps to help reduce their risk of Naegleria fowleri infection. Individuals should focus on limiting the amount of water going up their nose. Preventative measures recommended by the CDC include the following:

  • DO NOT allow water to go up your nose or sniff water into your nose when bathing, showering, washing your face, or swimming in small hard plastic/blow-up pools.
  • DO NOT jump into or put your head under bathing water (bathtubs, small hard plastic/blow-up pools); walk or lower yourself in.
  • DO NOT allow children to play unsupervised with hoses or sprinklers, as they may accidentally squirt water up their nose. Avoid slip-n-slides or other activities where it is difficult to prevent water going up the nose.
  • DO run bath and shower taps and hoses for five minutes before use to flush out the pipes. This is most important the first time you use the tap after the water utility raises the disinfectant level.
  • DO keep small hard plastic/blow-up pools clean by emptying, scrubbing and allowing them to dry after each use.
  • DO use only boiled and cooled, distilled or sterile water for making sinus rinse solutions for neti pots or performing ritual ablutions.
  • DO keep your swimming pool adequately disinfected before and during use. Adequate disinfection means:

Residents should continue these precautions until testing no longer confirms the presence of the amoeba in the water system. Residents will be made aware when that occurs. For further information on preventative measures, please visit the CDC website here: http://www.cdc.gov/parasites/naegleria/prevention.html.