Will producers of Listeria-tainted cantaloupe be fined or jailed? Earlier this week Food Safety News reported that the CDC had increased the numbers of those considered to be culture-confirmed cases from the 2011 cantaloupe Listeria outbreak from 146 to 147 and confirmed that the death toll now stands at 33. Of course, the death toll is in fact much larger — likely as high as 37 or 38 — and, there may well be many more that were sickened by the tainted cantaloupe who are not officially counted as part of the outbreak. So, now we know that a total of 147 persons infected with any of the five and possibly six outbreak-associated strains of Listeria monocytogenes were reported to CDC from 28 states.  The number of infected persons identified in each state was as follows: Alabama (1), Arkansas (1), California (4), Colorado (40), Idaho (2), Illinois (4), Indiana (3), Iowa (1), Kansas (11), Louisiana (2), Maryland (1), Missouri (7), Montana (2), Nebraska (6), Nevada (1), New Mexico (15), New York (2), North Dakota (2), Oklahoma (12), Oregon (1), Pennsylvania (1), South Dakota (1), Texas (18), Utah (1), Virginia (1), West Virginia (1), Wisconsin (2), and Wyoming (4). Deaths were scattered in Colorado, Indiana, Kansas, Louisiana, Maryland, Missouri, Montana, Nebraska, New Mexico, New York, Oklahoma, Texas, and Wyoming. So, should brothers Ryan and Eric Jensen face criminal charges for these illnesses and deaths? In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards. Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear: Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by not more than three years or fined not more than $10,000 or both. A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $1,000, or both. However, did what the Jensen brothers do, or not do, constitute a crime? Let’s look at the facts. The FDA’s Investigation at Jensen Farms On September 10, 2011, with Colorado state officials, the FDA conducted an inspection at Jensen Farms and collected multiple samples, both product and environmental, for laboratory testing. Of the 39 environmental swabs collected from within the Jensen Farms packing facility, 13 were confirmed positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from three of the five outbreak strains. Of the 13 positive environmental swabs, 12 were collected at the processing line and one was collected from the packing area. Cantaloupe collected from the firm’s cold storage during the inspection also tested positive for Listeria — in fact, five of the ten samples collected were positive for Listeria — with PFGE pattern combinations that were indistinguishable from two of the five outbreak strains. After finding evidence of extensive contamination at Jensen Farms, the FDA, again with the assistance of Colorado state officials, conducted an environmental assessment at the facility in an effort to identify the practices and conditions that lead to such widespread contamination. The results of the assessment, which occurred on September 23 and 24, 2011, were disclosed in a report dated October 19, 2011. Among other things, the report notes: a. Facility Design: Certain aspects of the packing facility, including the location of a refrigeration unit drain line, allowed for water to pool on the packing facility floor in areas adjacent to packing facility equipment. Wet environments are known to be potential reservoirs for Listeria monocytogenes and the pooling of water in close proximity to packing equipment, including conveyors, may have extended and spread the pathogen to food contact surfaces.  Samples collected from areas where pooled water had gathered tested positive for an outbreak strain of Listeria monocytogenes. Therefore, this aspect of facility design is a factor that may have contributed to the introduction, growth, or spread of Listeria monocytogenes. This pathogen is likely to establish niches and harborages in refrigeration units and other areas where water pools or accumulates. Further, the packing facility floor where water pooled was directly under the packing facility equipment from which FDA collected environmental samples that tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from outbreak strains. The packing facility floor was constructed in a manner that was not easily cleanable.  Specifically, the trench drain was not accessible for adequate cleaning. This may have served as a harborage site for Listeria monocytogenes and, therefore, is a factor that may have contributed to the introduction, growth, or spread of the pathogen. b. Equipment Design: FDA evaluated the design of the equipment used in the packing facility to identify factors that may have contributed to the growth or spread of Listeria monocytogenes. In July 2011, the firm purchased and installed equipment for its packing facility that had been previously used at a firm producing a different raw agricultural commodity. The design of the packing facility equipment, including equipment used to wash and dry the cantaloupe, did not lend itself to be easily or routinely cleaned and sanitized.  Several areas on both the washing and drying equipment appeared to be un-cleanable, and dirt and product buildup was visible on some areas of the equipment, even after it had been disassembled, cleaned, and sanitized.  Corrosion was also visible on some parts of the equipment.  Further, because the equipment is not easily cleanable and was previously used for handling another raw agricultural commodity w ith different washing and drying requirements, Listeria monocytogenes could have been introduced as a result of past use of the equipment. The design of the packing facility equipment, especially that it was not easily amenable to cleaning and sanitizing and that it contained visible product buildup, is a factor that likely contributed to the introduction, growth, or spread of Listeria monocytogenes.  Cantaloupe that is washed, dried, and packed on unsanitary food contact surfaces could be contaminated with Listeria monocytogenes or could collect nutrients for Listeria monocytogenes growth on the cantaloupe rind. c. Postharvest Practices: In addition, free moisture or increased water activity of the cantaloupe rind from postharvest washing procedures may have facilitated Listeria monocytogenes survival and growth. After harvest, the cantaloupes were placed in cold storage. The cantaloupes were not pre-cooled to remove field heat before cold storage. Warm fruit with field heat potentially created conditions that would allow the formation of condensation, which is an environment ideal for Listeria monocytogenes growth. The combined factors of the availability of nutrients on the cantaloupe rind, increased rind water activity, and lack of pre-cooling before cold storage may have provided ideal conditions for Listeria monocytogenes to grow and out-compete background microflora during cold storage. Samples of cantaloupe collected from refrigerated cold storage tested positive for Listeria monocytogenes with PFGE pattern combinations that were indistinguishable from two of the four outbreak strains. See FDA Environmental Assessment Report, Attachment No. 1. After conducting this environmental assessment, the FDA issued a warning letter to Jensen Farms, indicating, “we may take further action to seize your product(s) and/or enjoin your firm from operating. Additionally, the receipt of this warning letter and any action taken to correct the violations cited in it do not preclude a subsequent criminal prosecution by the United States Department of Justice.” See FDA Warning Letter to Jensen Farms, Attachment No. 2. To date, despite at least 33 deaths, one miscarriage, and 147 confirmed illnesses nationally, no criminal indictments have issued in this outbreak — yet. But the FDA did not close its file on this outbreak after issuing its very clear warning.  Officials from the agency also participated in the much-publicized briefings with the House Committee on Energy and Commerce in October and December 2011. At those meetings, FDA officials cited multiple failures at Jensen Farms, which, according to the Committee Report, “reflected a general lack of awareness of food safety principles.” Those failures, several of which draw from the FDA’s Environmental Assessment Report, included: – Condensation from cooling systems draining directly onto the floor; – Poor drainage resulting in water pooling around the food processing equipment; – Inappropriate food processing equipment which was difficult to clean (i.e., Listeria found on the felt roller brushes); – No antimicrobial solution, such as chlorine, in the water used to wash the cantaloupes; and – No equipment to remove field heat from the cantaloupes before they were placed into cold storage. In particular, the FDA heavily criticized the decision not to chlorinate the water used to wash cantaloupes, despite the fact that the wash was not re-circulated, as well as the use of improper processing equipment in the packinghouse. As is discussed below, both of these factors not only contributed to the cause of the outbreak, but also were the subject of discussion and recommendation by Primus Labs and its agent Bio Food Safety during the latter’s 2011 audit at Jensen Farms. In short, the conditions, personnel, and facility in general at Jensen Farms in summer 2011 did not just fall well-short of good manufacturing practices and industry standard, they violated FDA guidance on the safe production of cantaloupes. In fact, this is specifically the opinion held by FDA officials who spoke with the Committee in October and December: “FDA officials stated that the outbreak could have likely been prevented if Jensen Farms had maintained its facilities in accordance with existing FDA guidance.” See Energy and Commerce Committee Report, Attachment No. 3. So, if you were the U.S Attorney in Colorado, or any of the other states with victims, would you charge Ryan and Eric Jensen with a crime? Would it be a felony or a misdemeanor? And, how many counts?

  • Not an attorney, but I’d have to say this is a tough one. If I remember correctly, didn’t the Jensen brothers have a third party audit that gave them a clean bill of health? Wouldn’t this be a mitigating factor?
    And their actions, while stupid in the extreme weren’t deliberate; not like what happened with Peanut Corp. If anyone should be criminally charged, shouldn’t Peanut Corp’s Parnell be charged?
    What’s important is making sure events like this don’t happen again, oo that people won’t die in the future because a like event occurs. Would putting these guys in prison make this happen? Or would it be better to put procedures in place so that a Jensen Farms just can’t happen again?
    Food safety is about prevention before the fact, not punishment after. The only time we pursue the post-event punishment (such as fines, lawsuits, even prison) is when preventative measures aren’t sufficient, and the only recourse we have is punishment.
    Is prison the only recourse we have to prevent a future Jensen Farms?
    (You all are the ones with the lawyer, I guess you’ll have to answer these questions.)

  • Linda Querryl

    Because the outcome of their failure to comply with known safety standards resulted in such horrific outcomes, illness and death, I believe that this case should be prosecuted. The potential punishment, 3 years and $10,000 seem way to small for the seriousness of this negligence. We have too many unsafe practices that cause too many deaths in this country. I would like to see more cases having legal consequences. Perhaps it would alert the more lax food handlers to be more consciencous. We also need more funding for regulators. If there were more people reviewing safety standards the errors on this farm could have been remedied before anyone lost their lives, or these brothers had to live with the knowledge that their lack of knowledge, or laxity caused the loss of life.

  • lin sasman

    As a retired govt tty who prosecuted health and safety violations I say NO
    for the reasons
    1) civil consent degrees are more appropriate unless behavior is clearly willful and with intent to disregard safety
    2) “guidance” is a weaker law and easier to overturn in court
    3) the govt should focus on ordering upgrades to the facility, plus making company pay for third party monitoring and testing or 2-5 years so that behavior can change
    4) criminal cases are MUCH MORE EXPENSIVE for govt slim resources which also need to factor all kinds of other aspects besides safety
    5) the battle is this facility but the war is all facilities -the industry – civil judgments can be publicized, encourage other facilities to tighten ship without getting the backs up of other producers who do not want to feel demonized/ without setting up much more severe backlash – the govt must be seen as FAIR or the political-regulatory WAR is lost
    6) the amount of inconsistent govt advice/statements to producers carries weight in industry and courts

  • husna (MS Food Science)

    Why blame one Jenson farm when there are so many facilities getting away with food safety violations?
    Just mandating companies to follow a guidance document in relation to food safety is not the solution to the problem. Federal food agencies need to hire more food safety inspectors to inspect and perform their own audits at every food distribution facility, and they need to do it atleast 2-4 times a year. If this one change is adopted by FSMA, then food safety violations will dramatically decrease across the US as facilities would be scurrying to take measures to avoid penalities!

  • Here is a post that compares some of the facts between the Peanut Corporation of America Salmonella Outbreak, the Wright County Egg Salmonella Outbreak and the Jensen Farms Cantaloupe Listeria Outbreak:

  • According to what you’ve written, all three incidents could result in misdemeanor charges. I doubt any of the three could ever be prosecuted for a felony–even the Peanut Corporation. One doesn’t have to be a lawyer to guess the odds of any attempt to seek a felony conviction.
    If we charged all these people, though, wouldn’t we also have to charge the FDA? The USDA? The state governments responsible? Congress?
    We supposedly have safe food laws, but the agencies responsible don’t enforce them consistently. If they did, then some CAFO owner would be on the phone to his or her congressional rep, and next thing you know, the agency involved would be called in front of a committee hearing for “overreaching”.
    And the laws are manipulated to favor the industry as much as the consumer. Even now the government wants to cut back on inspections for chickens–putting all effort solely in the hands of the owners.
    Imagine: chickens whizzing by at the speed of a bullet train. Yes, this will end well.
    We have more people in jail, on average, than any other country in the world. Do we really think putting these people in jail will make our food systems safer? I think the answer is, No.
    It might be satisfying, and it may even be “justice”, but it won’t bring back the dead, or prevent any future dead.
    What will make our food systems safer is consistent laws applied consistently. Real and meaningful fines and actions–strong enough and consistent enough so that no individual feels the “game” is in his favor, and he can just play the odds.
    Laws that are not attacked and tossed aside by a capricious Congress pandering to the latest group du jour.
    Mr. Marler, there are too many Jensen brothers, and Peanut Corporations, and DeKosters. They’re birthed by demands for cheap, plentiful food that still manages to make big profits. They exist because, as a whole, we really don’t care about safe food; not if it means Big Government and More Taxes and, horrors, not having enough money to buy the latest, greatest iPad.
    We made these people. Might as well toss us all in jail.

  • John

    The solution is to HEAVILY tax ALL imported produce. Our American growers cannot compete with the cheap labor and cheap land and toxic chemicals that mexico and the rest are using. Because of this, our growers have to cut corners everywhere, including food safety. If our growers could sell their produce for a little bit of a profit instead of a loss, then they would have more money to put back to food safety. Of course, this wont happen. Instead, we are going to tax and litigate and regulate ALL of our growers right out of business. ALL of our food will come from china and mexico, and we will forever be on the verge of extreme famine.

  • Jon

    In order to be able to supply WalMart and the other large scale food purveyors Jensen Farm had to pass a full safety audit –which they did with top grades shortly before their melons went on to cause widespread illness and death. All the processing equipment failures targeted by FDA in their contamination findings were fully in place at the time of the audit.
    WalMart seems to have pulled an end run around the more expensive California growers’ product by sourcing cheaper melons from Jensen. This (and cheap imports from China, etc) is a direct result of “Always Lower Prices, Always” while they maximize profits via wide scale distribution schemes.
    If you’re going to stick the Jensens in the slammer — then it’s only fair to save adjoining cells (not CEO Country Club jails) for the CEO profiteers of the audit corporation and WalMart — with even longer terms to match their increased responsibility. It’s plain to see that our industrialized food system is the primary felon here — for meat, eggs, peanuts, ETC ETC.

  • husna aijaz

    Nice article about a breakthrough in pathogen detection found by researchers in the University of Columbia

  • husna

    Sorry for the error in my previous post..its the University of Georgia (UGA researchers), not Columbia that have come up with the breakthrough single step procedure to detect pathogens. The research is supported by USDA and NSF.