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Cyclospora Infections are up this Summer Sickening Nearly a 1,000 Persons in 36 States

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The CDC Report

The CDC reported that since the beginning of 2017 to mid-September there have been 988 Laboratory confirmed cases of Cyclospora infected people in 36 states of the USA. The number of cases this year is significantly higher than in 2016.
The states with the most cases are Texas 28.8%, Florida 12.0%, and New York (including NYC) 10.6%.

Historical View

While the number of cases is higher this year, the director of CDC’s Division of Parasitic Disease, Dr. Monica Parise, said: “The numbers from this year were probably not outside the range that we’ve seen for the last five years,” According to Parise the numbers last year were low.
The CDC claims that it is not unusual to see an increase in Cyclospora infection in the US between May and September. However, as the table shows the increase this year seems to be outside the norm.   In the last decade, only in 2005, the number of cases came close to this year, with 582 people sick in Florida. The outbreak source was identified as basil from Peru.

Reason for the Outbreak

Currently, no specific product has been connected to the infections, and it is unclear if the various cases in the different states are related to each other. The specific vehicles of the infections have not been identified and the sources are being investigated. The CDC report claims that “It is too early to say whether cases of Cyclospora infection in different states are related to each other or to the same food item(s).”

The EPI Curve

The EPI curve shows the progression of illnesses in an outbreak over time. It shows when people become ill by day. There is an inherent delay between the date that an illness starts and the date when the case is reported to public health authorities.  For the Cyclospora outbreaks in 2017, the following curve was generated by the CDC
*N=553. Data are current as of 9/13/17.  These cases occurred in persons with no history of travel outside of the United States or Canada in the 14 days before onset of illness. Illnesses that began after Aug. 2 may not yet have been reported to CDC because of the lag time between a victim’s first doctor visit, lab tests, paperwork and finally reports being filed with public health agencies. 

Cyclosporiasis

Cyclosporiasis is an intestinal illness caused by the unicellular parasite Cyclospora cayetanensis. According to the CDC, People can become infected with Cyclospora by consuming food or water contaminated with the parasite.
The oocysts shed in the feces of infected persons must sporulate outside the host, to become infective for another person. Therefore, it is not transmitted usually from person to person, but through food or water. The sporulation process requires days to complete.
Cyclospora is by and large found in tropical and subtropical countries. It is normally not killed by most chemical disinfectants.
Products that historically caused outbreaks include fresh produce: basil, cilantro, lettuce, raspberries and snow peas.

Questions

Why do we see a higher number of infections despite FDA preventative measures?
Due to a number of outbreaks traced to fresh cilantro from the region of Pueblo, Mexico, the FDA increased inspection and enforcement there. According to the FDA “Beginning in 2015, from April 1 through August 31, cilantro from this region has been and continues to be detained without physical examination at the U.S.-Mexican border and refused admission into the United States.”
The FDA suggested in September 2016 that the lower number of infections that year correlated with the first full season that the FDA’s Import Alert for fresh cilantro from Puebla was in effect. Therefore, the question should be asked why we see such an increase this year.
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FDA Commissioner Announced a Four Year Delay in Implementing Some Produce FSMA Rules

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In a speech in front of National Association of State Departments of Agriculture (NASDA), Dr. Scott Gottlieb, the FDA commissioner outlined some immediate steps to facilitate the implementation of the Produce Safety Rule established by the FDA Food Safety Modernization Act (FSMA).
Dr. Gottlieb claims that since being in his post, he gained a deeper appreciation for the challenges and complexity that the globalized farming community is facing.

Agricultural Water Compliance Dates

He announced that the FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts).  The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms would have until January 26, 2023, and very small farms January 26, 2024.
Sprouts, because of their unique vulnerability to contamination, remain subject to applicable agricultural water requirements in the final rule and their original compliance dates. 
He agreed that “microbial quality standards for agricultural water are too complicated, and in some cases too costly, to be effectively implemented.” Dr. Gottlieb also announced that “our intention to explore ways to simplify our approach to make compliance less burdensome and less costly, while still being protective of public health.”
To give the agency and the farmers more time, he is issuing an extension in the compliance dates” for the agricultural water requirements of the produce rule for non-sprout produce by an additional two to four years. This way the earliest non-sprout compliance date for the water standards won’t be until January 2022.”
The proposed extension will give the agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country while protecting public health. The agency has also increased the number of methods that can be used for water testing in agricultural water.

Educational Efforts

Dr. Gottlieb declared that the agency has recognized a need for additional efforts to educate the produce industry and state regulatory agencies on the new produce safety requirements, and will continue its focus on training, guidance development, and outreach over the next year. This is particularly important since the nation’s farming community has not previously been subject to this kind of oversight.
The FDA plans to learn more from farmers, state regulatory partners and other stakeholders about the diverse ways water is used and ensure that the standards will be as practical and effective as possible for all farming operations, during the time extension afforded by the extension.

Produce Inspection

The State Produce Implementation Cooperative Agreement Program that supports 43 states in their development of produce safety programs was awarded $30 million. This funding is in addition to on the nearly $22 million that FDA awarded last year to 42 states to develop produce programs and provide training and technical assistance.
Dr. Gottlieb assured the audiences that routine inspections would not begin until 2019. The additional time should be used to focus on issuing guidance that will be helpful to regulators and farmers.

On Farm Readiness Reviews

The farm readiness review is a voluntary program, where the farms are visited by a team of state officials, cooperative extension agents, and FDA produce experts.  The purpose of the visit is to give the farmers information about their readiness to meet the program requirements. The program will also help the FDA to identify training gaps that will be needed to be filled.

Training

Dr. Gottlieb claimed that through Produce Safety Alliance (PSA) 176 farmer training courses had been conducted in 36 states as of June of 2017. More than 1,000 trainers were trained in these courses. NASDA-FDA working group was formed to work on plans for training state and federal inspectors and is finalizing the training modules.
FDA is also working with NASDA to determine the best training platforms for ensuring that cooperative extension agents can have the training they need to be effective. Training of state regulators will be a top priority for the FDA in 2018.
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Biofilm and food safety: What is important to know?

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Part 2: What are the best control strategies?

Dr. Bassam A. Annous, Eastern Regional Research Center, USDA–ARS–NEA, and Dr. Ruth Eden, BioExpert.
Biofilms are usually formed in a wet environment and in the presence of nutrients.  Once biofilms are formed, the cleaning of the food and food contact surfaces becomes more difficult to remove the extracellular polymeric substances (EPS). Therefore, prevention of biofilm formation, using regularly scheduled cleaning and disinfecting protocols is an important first step in preventing cells from attaching and forming biofilms on surfaces.
High-temperature washing can reduce the need for the physical force required to remove biofilms. Chemical cleaners suspend and dissolve food residues by decreasing surface tension, emulsifying fats, and denaturing proteins. The mechanism by which cleaning agents remove EPS associated with biofilms has not been determined.

Fruit and Vegetable Surfaces

Conventional methods of washing fresh produce with hypochlorite or other sanitizing agents cannot assure microbial safety because they can only achieve 1-2 log reduction. This is because of many enteric pathogens, such as Escherichia coli O157:H7, cause illness at very low infectious doses. For apples, using water, detergents or sanitizing agents, produced a maximum of 3-log (99.9%) reduction in the levels of E. coli. The same treatment using brush washer surprisingly gave less than a 1-log (90%) reduction in E. coli.
A commercial-scale surface pasteurization treatment developed at ERRC (Annous, Burke, and E. Sites), resulted in 4-log (99.99%) reduction in the population of Salmonella Poona on the surface of artificially contaminated cantaloupe. The process involved the immersion of melons in water at 168.8°Fahrenheit for three minutes and then rapidly cooling them. This pasteurization process not only enhances the safety of the fruit but increases the product shelf life by reducing the native microflora that may cause spoilage.

Equipment

Bacterial cells could attach and form biofilms on food processing equipment.  The complexity of processing equipment makes it difficult to remove and/or inactivate the bacterial cells in biofilms on food processing surfaces.  Since it is extremely difficult to remove these biofilms, food processors should prevent biofilm formation in the first place. This could be done by developing and maintaining a thorough sanitation regiment to help prevent a biofilm layer from attaching to equipment surfaces. Product residues due to spills or debris in the facility support bacterial proliferation and subsequent biofilm formation. Consequently, regular removal of food residues is a key to preventing biofilm formation.
Oko, 2013 suggested three important steps to removing biofilm in a food processing facility:
(i)     Cleaning with appropriate sanitizing agents at the required concentrations
(ii)     Allowing enough exposure time at the appropriate temperature
(iii)     Applying mechanical action
This combination is claimed to penetrate and/or remove the biofilm, and thereby to kill the embedded bacterial cells.
An effective cleaning procedure would break up or dissolve EPS allowing sanitizers to gain access to viable bacterial cells. Alkaline cleaners, especially those with chelators like EDTA, are more effective at removing biofilms than acidic cleaners. Bacteria become far more susceptible to sanitizers once the biofilm matrix has been destroyed, certain enzymes have been proven effective in disrupting EPS matrixes, thus allowing for the removal of biofilms. Recently, novel methods that can serve as alternatives to the current methodology for the disinfection of microbial contamination, such as essential oils and bacteriophages have been successfully tested.
Poly ethylene glycol (PEG) has been shown to inhibit protein adsorption and bacterial attachment to surfaces.  Cold plasma was used to deposit PEG-like structures on the surfaces of stainless steel 304 and 316L using 12-crown-4 ether and tri (ethylene glycol) dimethyl ether (triglyme), and ethylene glycol divinyl ether as starting materials.
The plasma modified surfaces significantly reduced biofilm formation by about 80%. When 1% beef hot dog was added to the base medium, biofilm formation on stainless steel 304 was reduced further. Plasma modification of the surfaces did not interfere with the efficacy of cleaning by the chlorinated alkaline detergent.
Newer physical methods of biofilm removal include super-high magnetic fields, ultrasound treatment, high pulsed electrical fields, combined use of high pulsed electrical fields in conjunction with organic acids, and low electrical fields alone or in combination with biocides, such as silver, carbon, platinum, and antibiotics.

Summary

Most bacterial cells in nature exist in biofilms instead of planktonic single cells.  Organic and inorganic material (nutrients) attach to surfaces of food and/or equipment and thus creates a conditioning layer whereby microorganisms attach to. Microbial cells then start secreting EPS that further help in the attachment of the biofilm to the food and food processing surfaces.  The ESP formation acts as a barrier from sanitizing compounds, making the biofilm stronger. Bacterial activity within the biofilm community can be coordinated through cell-to-cell signaling (Quorum sensing).
Biofilm formation is associated with many foodborne outbreaks. As a result, biofilm has become a problem in food industries as it renders its inhabitants resistant to antimicrobial agents and cleaning agents. The growth of biofilms in food processing environments leads to an increased opportunity for microbial contamination of the processed product.  Pathogenic microorganisms in biofilms are the major source of food contaminations.
Biofilms were created by various bacteria on fruit and vegetable surfaces, on various meats, and especially on all types of processing equipment.  Once created the biofilm is very difficult to remove, and offer significant protection to the bacteria residing in it.
Breaking up EPS is important in eliminating the biofilm protection and making the bacterial cells more susceptible to the cleaning sanitizers.  Several novel methods are available to better clean surfaces containing bacteria in biofilms.
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The Papaya Salmonella Outbreak Expands as Number of Victims Triples

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The Recalls

Since our last report on July 23, there have been several additional recalls associated with the outbreak of Salmonella in papayas. On July 26 after many people got sick, Grande Produce issued a recall for its imported papayas from the Carica de Campeche farm in Mexico. This farm seems to be the primary source of the outbreak. 
On August 4, a second papaya recall was issued by Agroson’s LLC, for more than 2,000 boxes of Cavi-brand Maradol Papaya imported from the same Mexican farm. A few days later, a third papaya recall was issued by Freshtex Produce. These papayas sold under the Valery brand were distributed in Illinois.
Carica de Campeche farm produced papayas under the following brands: Caribeña, Cavi, and Valery.
The FDA first recalled the Maradol papayas from the Carica de Campeche farm in Mexico.
 
Carica de Campeche farm under the brand Caribeña: This first recall came after extensive testing and trace back.  Papayas from the Carica de Campeche farm tested positive for Salmonella Kiambu, Salmonella Thompson, Salmonella  Agona,  Salmonella Senftenberg, and Salmonella Gaminara. The Caribeña brand was distributed by Grande Produce between July 10 and 19, 2017.
 
Cavi brand papayas distributed by Agroson’s:  Agroson’s LLC, recalled certain Maradol Papaya Cavi Brand, grown and packed by Carica de Campeche.  The papayas were distributed on July 16-19 and were available to consumers until July 31. No illness has been reported due to the Maradol Papaya Cavi Brand, and the recall was voluntary in cooperation with the FDA.
 
Valery brand distributed by Freshtex: The FDA announced that Freshtex Produce of Alamo, TX was voluntarily recalling “Valery” brand Maradol Papayas grown and packed by Carica de Campeche. The papayas were distributed to the State of Illinois from July 10 to July 13, 2017. No illness has been reported.
The FDA increased its testing to see if papayas from other farms from Mexico could be contaminated. More brands and distributors are expected to be linked to the investigation.

The Outbreak

The CDC found that as of August 9 a total of   141 people were infected with the outbreak strains of Salmonella Kiambu (51) or Salmonella Thompson (90) in 19 states. Among 103 people with available information, 45 (44%) have been hospitalized.
The data from the testing laboratory and from epidemiological investigation indicated that the most likely source of the outbreak was Maradol papayas from Carica de Campeche farm in Mexico.

Why did it Happen?

Papayas from Mexico are being screened at the border for Salmonella since the outbreak in 2011, by a third party laboratory. Only papayas that have tested negative for Salmonella are allowed into the USA.  The question needs to be asked: how was it possible that the contaminated papayas were able to get into the USA?
As shown in our recent post, research indicated that bacteria can attach and colonize on the surfaces of plants, ultimately forming biofilms. Bassam A. Annous 2005  shows Salmonella produces fimbriae and cellulose, commencing biofilm formation, which helps Salmonella attach and colonize on melon and cantaloupe surfaces. Once attached the cells survive better on the surface.
As mentioned in our previous post, the outbreaks can be due to the ability of Salmonella to attach or internalize into fruits.  Survival and multiplication of Salmonella on fresh fruits is considerably increasing once the protective epidermal barrier has been broken.    FSMA is designed to help minimize the risk of illness from foodborne pathogens in fresh fruits, and include requirements for water quality, employee hygiene, and equipment and tool sanitation. However, to date, all these new measures did not prevent the current papaya outbreak.

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Biofilm and food safety: What is important to know?

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Dr. Bassam A. Annous, Eastern Regional Research Center, USDA–ARS–NEA, and Dr. Ruth Eden, BioExpert.

Part 1: What are Biofilms?

In nature, most bacteria do not exist as suspended (planktonic-free floating) cells. Bacteria live in a group (mass of bacterial cells) attached to each other and to surfaces, in a biofilm form.
A biofilm is as a complex community of microorganisms, embedded in self-created extracellular polymeric substances (EPS). Therefore, the biofilm is a microbial population adherent to each other and to surfaces or interfaces enclosed in the matrix. In this complex biofilm network of EPS, the bacterial cells perform less as individual cells and more as a collective living system, frequently creating channels to deliver nutrients and water to the cells located inside the biofilm.
Bacteria create biofilm as a protection mechanism, for better survival in the environment. Cells in a biofilm are more resistant to cleaning and disinfection processes in the food industry. The bacteria in the biofilm attaches so firmly to the equipment’s surface that it becomes resistant to conventional sanitation procedures used by the food industry.
Various techniques such as molecular methods, chemical methods, and physical methods have been used to better understand the complex mechanism of biofilm formation, and to get an insight into how to create a process that will eliminate the biofilm formation and/or inactivate cells within the biofilm.
Moisture and nutrients from food (organic and inorganic material) are commonly found on production lines. These two elements bond together to create a conditioning layer. This layer allows for the initial attachment of the bacterial cells to the surface of the layer and the secretion of EPS. The production of ESP enhances the biofilm attachment to the food contact surfaces and protects the cells within the biofilm from the external stresses such as sanitizing agents.

How is Biofilm Formed?

The formation of biofilm can be described as a stepwise process, as shown in Figure 1, consisting of:
  1. Initial reversible attachment of the planktonic (free-floating) bacteria cell to the surface
  2. Irreversible attachment by the production of EPS
  3. Bacteria multiplication and development of biofilm structure
  4. Development of a microcolony covered by mature biofilm, stabilizing the microcolony from environmental stress
  5. Dispersion of cells from the biofilm into the surrounding, and the return of cells to their planktonic form.
 
Figure 1: Formation of biofilm (adapted from Wikimedia , and Firstenberg-Eden et al )
Organisms in a biofilm act less as individual cells and more as a combined living system and are significantly more resistant to environmental stresses such as antibiotics, sanitizers, chemical stress (pH, oxygen) and biocides than their planktonic cells. This increase in resistance to external stresses, as well as a shield against desiccation, is probably due to the presence of the EPS material.
Quorum sensing (cell to cell signaling) has been shown to play a role in biofilm formation, allowing bacteria to display a unified response that benefits the whole population. Research shows that transfer of antibiotic resistance gene is common in the biofilm environment. This transfer happens readily through conjugation or transformation.
Quorum sensing also enhances the ability of bacterial cells within the biofilm to access nutrients and increases their defense mechanism against competing bacteria and environmental stresses.
A recent publication in Cell showed that bacteria residing within biofilm communities could coordinate their behavior through cell-to-cell electrical signaling. Combining experimental data and mathematical modeling point to an extracellular potassium produced in the biofilm as a mechanism of changing the membrane potential of remote cells, thus, directing their motility.
Therefore, cells embedded within the biofilm can not only influence their behavior but influence the behavior of far-away cells through electrical signaling.  A genetic mechanism appears to allow electrically mediated attraction between bacterial species

Why are Biofilms important to Food Safety?

Continual low-level contamination can be caused by biofilm, releasing bacteria, including pathogens and therefore, causing a food safety concern. Bacteria residing in biofilms are more resistant to antimicrobial agents and cleaning agents. Biofilms on processing equipment can reduce the lethality of the process.
Attached cell increased resistance to cleaning chemical because of the protection provided by the EPS layer. The decreased effectiveness of chemicals might also be as a result of cells being in a compact format reducing exposed surfaces that the chemical can make contact with the bacteria.
Product contamination can occur as bacteria detach from the microcolony periodically and can contaminate the processed foods and the lines.  Pathogenic bacteria such as, Listeria, Salmonella, E. coli, or Pseudomonas, can form a multi-species biofilm, which is more stable and resistant to sanitizing agents.
 
Many outbreaks of foodborne disease are associated with biofilm. Research shows that biofilm has become a problem in food industries such as dairy, fish processing, poultry, meat, and Ready-To-Eat foods, because of the residing organisms increased resistance to external stresses.

Biofilm formation on food surfaces

Fruit and vegetable

Research has shown that bacteria can attach, colonize on the surfaces of plants, eventually forming biofilms. The ability of sanitizers to inactivate the bacterial cells in the biofilm is significantly reduced
Disinfection steps by a diverse group of chemicals (e.g., chlorine, peroxide, surfactants, organic acids, etc.), UV, and irradiation were tested without successfully eliminating pathogens in the biofilms formed on fresh produce (without significantly affecting the product quality).  Pathogens that are incorporated into mixed-species biofilms make them less susceptible to antimicrobial treatments as well as increase their tolerance to other stresses such as desiccation and UV.
Biofilms on plant surfaces are composed of a wide variety of bacterial species.  The population dynamics of biofilms vary greatly corresponding to environmental conditions such as temperature, relative humidity, and the availability of nutrients.
Biofilm formation on plant surfaces is probably a survival mechanism for bacteria to endure harsh environment, including desiccation, UV exposure, and temperature fluctuations.
Research data (Bassam A. Annous 2005 ) shows Salmonella produces fimbriae and cellulose, starting biofilm formation, which helps the organism attach and colonize on melon and cantaloupe surfaces. Once attached to the fruit Salmonella cells survive better, and are less susceptible to the harsh sanitizing environment. The organism becomes difficult to remove from the cantaloupe surfaces due to attachment to inaccessible sites and biofilm formation on the cantaloupe rind surface, thus avoiding contact with the sanitizing solution.
After that, the surviving cells can be transferred from the surface of the fruit into the internal tissue of the fruit during processing, presenting a major obstacle for ensuring the microbiological safety of fresh-cut cantaloupe.
The produce most frequently associated with outbreaks include cantaloupe melons, apples (unpasteurized juice or cider), and leafy greens.

Meat

There are meat surfaces to which bacteria attach readily and other meat surfaces to which they attach much slower. The smooth chicken breast muscle (fascia) was the best surface for attachment of all bacteria examined. A linear relation between the concentration of bacteria attached to the surface and time during the attachment process was observed. On some surfaces, this linearity continued for a long time [teats of a cow, chicken breast with fascia, chicken skin]. Bacterial strain also impacts the attachment kinetics.
The bacteria are easily removed in the water film stage. With time, these bacteria could attach to the meat and become difficult to remove due to EPS formation. Brown et.al showed the attachment and biofilm formation by Campylobacter jejuni to extruded chicken meat. They demonstrated that chicken juice contributes to C. jejuni biofilm formation by covering and conditioning inert surfaces and is a source of nutrients. The organism preferentially attached to chicken juice particulates, increasing the attachment rate.
 
Escherichia coli O157:H7 from cattle had the ability to produce biofilm on food contact surfaces such as stainless steel. The attached organisms in the biofilm were able to transfer onto a variety of products such as raw meat, raw poultry, ready-to-eat deli meats, and produce products.
Strains isolated from cattle, retail chicken, and retail beef were able to form strong biofilms in addition to curli fimbriae and EPS production.
Spoilage and/or Pathogenic bacteria can attach to production food contact surfaces, and eventually form a biofilm. The biofilm formation is a major challenge to the meat industry due to the potential of cross-contamination of the meat, causing short-shelf life and/or spread of diseases.

Equipment

Both Gram negative and Gram positive bacteria present on food processing equipment can colonize on stainless steel.  Gram-negative bacteria produced much greater biofilms on stainless steel than Gram positives.
The ability of Listeria monocytogenes to develop biofilms and survive on different types of materials was studied by Wong 2002. The materials studied included two types of stainless steel (304 and 316L), two types of rubber (Buna-N and silicone), and three materials used in conveyor systems (Polyester 3000 and TURE-2 used as belting material, and Delrin, a hard plastic, used in rollers for conveyor belts).
Biofilm formation was best supported by the plastic material Delrin, followed by stainless steel type 304. Food grade silicone rubber and stainless steel type 316L surfaces were the most resistant to biofilm development. L. monocytogenes was capable of forming a biofilm at 10°C, in low nutrient medium on all surfaces tested. The 5-day biofilm cells were more resistant to cleaning and sanitizers as compared to the 2-day biofilms.
The persistence of bacterial cells within a biofilm in the whole food industries including cheeses, dairy products, raw foods, and ready to eat produce continue to contribute to the short shelf-life and/or human pathogenic foodborne outbreak. ESP Material produced by the bacterial cells in biofilms and the complexity of processing equipment makes it difficult to remove and/or inactivate these bacterial cells on food processing surfaces. Therefore, biofilm control relies on the implementation of effective cleaning and sanitizing procedures. Also, the design of processing equipment and the food processing environment that reduces and/or eliminates the accumulation of bacterial and that allows easy, and thorough soil removal can be a significant issue in controlling biofilm formation.
Comming soon our second chapter about Part 2: What are the best control strategies?
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FDA Erroneous Warning Costs Tomato Growers $15 Millions – Court Rules: FDA is Not Liable

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tomato1 On December 2, the 4th U.S. Circuit Court of Appeals ruled that the FDA could not be held financially liable for issuing the false warning.  It is clear now that the FDA warning did not help customers who stopped buying perfectly healthy tomatoes, and continued to buy the contaminated hot peppers. This decision was devastating to the tomato growers. The demand for tomatoes plummeted by 40% due to the warnings, and prices fell by 50%. The tomato industry lost millions of dollars.

Case History

As part of the ruling judge Wilkinson described the detailed history of the case: “On May 22, 2008, the New Mexico Department of Health notified the Centers for Disease Control and Prevention that a number of local residents had been infected with Salmonella Saintpaul. Similar reports soon arrived at CDC from Texas.   After interviewing patients, the CDC discovered a “strong statistical association” between the infections and eating raw tomatoes. This observation was supported by a “historical association” between salmonella and tomatoes. The CDC subsequently notified the FDA that tomatoes were the “leading hypothesis” for the source of the outbreak.   On June 7 2008, FDA issued an updated contamination warning titled, “FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes.”  At the time, Salmonella Saintpaul was linked to 1,220 infections across forty-two states and the District of Columbia, as Seaside Farm and other growers were harvesting a large crop of tomatoes.   Over the next month the CDC accumulated enough data to link Salmonella Saintpaul to jalapeño and serrano peppers imported from Mexico. Consequently the FDA withdrew the contamination warning  and announced that fresh tomatoes were no longer associated with the outbreak.   Seaside harvested a crop of tomatoes in South Carolina while the Salmonella Saintpaul contamination warning was in effect. By the time the agency admitted its error on July 17, the case had been amplified into the largest foodborne outbreak in the United States in more than a decade. The FDA incorrect warning costed producer millions and turned good tomatoes into waste.   On May 18 2011, Seaside brought suit against the United States under the FTCA (Federal Tort Claims Act) alleging that the FDA negligently issued the contamination warning and impaired the value of Seaside’s crop by $15,036,293.95. The FDA was accused that they had no confirmation of a link between the outbreak of Salmonella and their tomatoes, and that the analysis done was flawed.   On December 15 2015, the district court dismissed the case for lack of subject matter jurisdiction. The district court reasoned that the FDA had broad discretion to warn the public about a contaminated food supply, and that Seaside failed to allege any statute, regulation, or policy that required the FDA to proceed in a particular manner. The district court also acknowledged that contamination warnings were due to competing policy considerations of protecting the public from serious health risks and minimizing any adverse economic impact on associated industries.

The Ruling

The 4th Circuit agreed with the trial court that the FDA was acting within its authority to issue emergency food safety warnings based on preliminary information in order to protect public health. Turning down the $15 million claim from Seaside Farm, South Carolina   “We refuse to place FDA between a rock and a hard place,” wrote Judge Wilkinson for the panel, sitting in Richmond. “One the one hand, if FDA issued a contamination warning that was even arguably over broad, premature, or of anything less than perfect accuracy, injured companies would plague the agency with lawsuits,” the judge said. “On the other hand, delay in issuing a contamination warning would lead to massive tort liability with respect to consumers who suffer serious or even fatal consequences that a timely warning might have averted,” Wilkinson said.

Questions to be asked

When government agencies like the FDA send an erroneous warning, as clearly happen in this case, and the action caused losses of millions of dollars to the growers, should there be a remedy against the agency? Should anyone be accountable for such losses? Should there be a compensation mechanism?   If there is a remedy against the agency, will it prevent the agency from issuing warnings before all facts are known, and endanger the public?