Faith-based food safety sucks

In a decision issued [June 19, 2019] in Marchand v. Barnhill et al., No. 533, 2018 (Del. June 19, 2019), the Delaware Supreme Court reversed the dismissal of a stockholder derivative lawsuit against the members of the board of directors and two officers of Blue Bell Creameries USA, Inc.

The lawsuit arose out of a serious food contamination incident in 2015 that resulted in widespread product recalls and was linked to three deaths. The Delaware Supreme Court, applying the “duty to monitor” doctrine enunciated in In re Caremark International, Inc. Derivative Litigation, 698 A.2d 959 (Del. Ch. 1996), and noting the very high hurdle to claims under it, nonetheless ruled that the plaintiff had adequately alleged the requisite bad faith by the members of the Blue Bell board.

Plaintiff did so by using information obtained in a Section 220 books and records demand to show facts supporting their contention that the Company did not have in place “a reasonable board-level system of monitoring and reporting” with respect to food safety, which the Court deemed to be “a compliance issue intrinsically critical to the company’s business.”

After concluding that “food safety was essential and mission critical” to Blue Bell’s business, the Supreme Court ruled that bad faith was adequately pled by alleging “that no board-level system of monitoring or reporting on food safety existed.” The Court thus declined to dismiss a claim that the directors breached their duty of loyalty, potentially exposing directors to non-exculpated (and potentially not indemnifiable) monetary damages.

In light of the Blue Bell decision, boards of directors should review carefully their board processes and procedures to ensure that “reasonable compliance system and protocols” are in place with respect to “safety and legal compliance” and other regulatory and business threats that may pose significant risks for their particular company.

Equally important, boards should document the procedures followed to identify significant risks, including advice from management, counsel and other advisors, as well as the processes and procedures implemented to provide for board reporting and appropriate supervision of these risks, and maintain written records of the implementation of these processes and procedures in practice. The principal basis upon which the Court in Blue Bell found the record to support the complete failure to impose any board-level “system of controls” with respect to food safety was the absence of any written board procedures or documented discussion on the topic, and the lack of any mention of food safety in board minutes in periods before the food contamination outbreak, despite previous food safety issues that allegedly had arisen in previous years, including positive tests for listeria in Company facilities beginning in 2013.

The Blue Bell decision makes clear that oversight with respect to these kinds of issues is a board-level responsibility, and goes beyond mere compliance with laws. The Delaware court opined that “the fact that Blue Bell nominally complied with FDA regulations does not imply that the board implemented a system to monitor food safety at the board level.”

“In short,” the Delaware Supreme Court ruled, “to satisfy their duty of loyalty, directors must make a good faith effort to implement an oversight system and then monitor it.” While “routine regulatory requirements, although important, are not typically directed at the board,” companies should ensure that they have written processes and procedures in place for the board to be timely informed about, and to monitor regularly, compliance, safety and business developments that are important to the company, or may be viewed as critical to the company in hindsight. [1]

This decision, while only on a motion to dismiss, illustrates the continued importance of the Caremar kdoctrine as a strand of Delaware law governing the conduct of directors. While the burden for withstanding a motion to dismiss a Caremark claim is high, and the theory remains “possibly the most difficult theory in corporation law upon which a plaintiff might hope to win a judgment,” [2] it can be met. Caremark is an important tool in the Delaware jurisprudential arsenal for enforcing what Delaware courts view as reasonable director conduct, and when applied sends a powerful message because of the potential it creates for personal director liability.

11.jul.19

Harvard Law School Forum on Corporate Governance and Financial Regulation

Brian Frawley, Joseph Frumkin and Krishna Veeraraghavan

https://corpgov.law.harvard.edu/2019/07/11/bad-faith-monitoring-on-food-safety-issues/

3 dead, 3 sick in UK hospital sandwich outbreak

I’ve told these Australian hospitals to stop serving raw sprouts and cold cuts to immunocompromised people.

They just call me crazy.

Three hospital patients in the UK have died in an outbreak of listeria linked to pre-packed sandwiches.

Public Health England (PHE) said the victims were among six patients affected in England and the deaths occurred in Manchester and Liverpool.

Two of the victims were at Manchester Royal Infirmary, with the other a patient at Aintree Hospital.

Sandwiches and salads from The Good Food Chain linked to the outbreak have been withdrawn and production ceased.

PHE said the products were withdrawn from hospitals when the links to the infections were first identified.

PHE said The Good Food Chain had been supplied with meat produced by North Country Cooked Meats which subsequently produced a positive test result for the outbreak strain of listeria.

This business and North Country Quality Foods, who it distributes through, have also voluntarily ceased production.

A spokesman for The Good Food Chain Ltd said the company’s production facility in Stone, Staffordshire, was “cross contaminated by an ingredient from one of its approved meat suppliers”.

5 dead, 22 sick: Multi-country outbreak of Listeria monocytogenes clonal complex 8 infections linked to consumption of cold-smoked fish products

The European Centre For Disease Prevention and Control reports a prolonged multi-country outbreak of 22 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 1247, clonal complex (CC) 8 has been identified through whole genome sequencing (WGS) in five EU countries: Denmark (9 cases), Estonia (6), Finland (2), France (1) and Sweden (4). Five patients have died due to, or with, the disease. The first case had symptom onset in July 2014 in Estonia, and the most recent case occurred in Denmark in February 2019. Eight patients, out of twelve for whom a food consumption history was available, confirmed the consumption of cold-smoked fish products.

L. monocytogenes food isolates, matching the human outbreak strain by WGS, were detected at wholesale and retail level in four countries (i.e. France, Denmark, Italy and Sweden) from 13 batches of cold smoked or gravad salmon and from six batches of cold smoked trout products. Traceability information of the contaminated batches pointed to the Estonian processing Company A as the single common manufacturer of these fish products. The raw fish was received from suppliers in Norway and Finland. Environmental investigations and food testing at the Estonian processing plant showed the presence of L. monocytogenes that matched the outbreak strain in two samples on the processing line and in four batches of the final product.

The presence of L. monocytogenes matching the outbreak strain over several years in the fish products suggests the persistence of the microorganism at the Estonian company’s premises. Further investigation is needed to identify points of cross-contamination in the food processing plant. Control measures were implemented in Estonia, Denmark, France and Italy following the RASFF (Rapid Alert System for Food and Feed) notifications, but until the source of infection has been identified and controlled, new invasive listeriosis cases associated with this event may still occur.  

In general, pregnant women, the elderly and immunocompromised individuals are at increased risk of invasive listeriosis, which is associated with severe clinical course and potentially death. 

Raw sprouts: food safety types won’t eat ‘em

A woman from a U.S. magazine interviewed me this morning about the risks of raw sprouts.

I was sorta nervous because I’ve been out of the media game for a while, but she played to my weaknesses and complimented me by saying I was imminently quotable, so I obliged, even though yesterday I couldn’t remember my phone number (writing allows one to go check things, talking, not so much).

I lost track a couple of times during the interview but she was sympathetic and I would defer by saying, it’s all on the barfblog.com, when I couldn’t remember something.

I did however note that many food service thingies have started using pea sprouts as substitutes for raw alfalfa or mung bean sprouts.

Pea sprouts are not yet widely consumed but I did note, the Canadian Food Inspection Agency launched a recall of pea sprouts because of Listeria contamination back in April, a recall that was expanded in May.

No one has been identified as sick, but I’m sure it will happen.

Here’s a table of over 75 sprout-related outbreaks going back to 1973.

Food Safety Talk 181: Hot Pants!

In this super long episode (sort of a double album) Ben and Don talk about their recent travels, PowerPoint as a performance and river cruising. The conversation takes a food safety turn into raw milk goat cheese, bull pizzles and veggie washes. They talk through some listener questions on surviving in the wild, foods they eat (and avoid) and pet food bowls. The show ends with some quick hits on phone cleaning, deli slicer-linked illnesses and geographical differences in pathogen exposure (and how the demise of the Aztec population is like Ontario beef farming).They answer the age-old question of what to do when there’s no paper towels in the restroom. They don’t talk about how the Toronto Maple Leafs are out of the Stanley Cup playoffs.

Food Safety Talk 181:Hot Pants! is available on iTunes and here.

Show notes so you can follow along at home:

Worry about it: 1 dead, 7 sick from Listeria linked to deli-sliced products: Is steaming hot the same as piping hot?

I do not buy stuff from the deli-counter. I buy stuff that is pre-packaged and may contain antimicrobials, depending on what country you are in.

It’s all about the slicers, whether it’s the little ones at the deli counter or the huge industrial ones in food facilities – I’m looking at you Maple Leaf, source of 23 dead in 2008 in Canada – and how hard they are to properly clean.

Should deli meats be served in hospitals or aged care facilities where the immunocompromised abound?

The U.S. Centers for Disease Control reports a total of 8 people infected with the outbreak strain of Listeria monocytogenes have been reported from 4 states.

All 8 people have been hospitalized, and one death has been reported from Michigan.

Epidemiologic and laboratory evidence indicates that meats and cheeses sliced at deli counters might be contaminated with Listeria monocytogenes and could make people sick.

In interviews, ill people report eating different types and brands of products, including meats and cheeses, purchased from and sliced at deli counters in many different retail locations.

The outbreak strain has been identified in samples taken from meat sliced at a deli and from deli counters in multiple stores.

A single, common supplier of deli products has not been identified.

CDC is not advising that consumers avoid eating products prepared at delis, or that retailers stop selling deli-sliced products.

Retailers should clean and sanitize deli slicers.d

This outbreak is a reminder that people at higher risk for severe Listeria infection should handle deli-sliced meats and cheeses carefully to prevent illness. Pregnant women and their newborns, adults age 65 and older, and people with weakened immune systems are more likely to get sick with listeriosis.

People who are at higher risk for Listeria infection should avoid eating lunch meats, cold cuts, or other deli meats, unless they are heated to an internal temperature of 165°F or until steaming hot just before serving.

If you develop symptoms of a Listeria infection after eating deli-sliced products, contact a healthcare provider and tell them you ate deli-sliced products. This is especially important if you are pregnant, age 65 or older, or have a weakened immune system.

If you have eaten deli-sliced products and do not have any symptoms of a Listeria infection, most experts believe that tests or treatment are not needed, even for people who have a higher chance of Listeria infection.

Listeria bacteria can survive at very low temperatures and can spread easily to other foods and surfaces. Consumers should clean refrigerators, kitchen countertops, utensils, and other surfaces that touch deli-sliced products.

You can take steps to prevent Listeria infection:

Don’t let juice from lunch meat and hot dog packages get on other foods, utensils, and food preparation surfaces.

Wash hands after handling deli meats, lunch meats, deli cheeses, and hot dogs.

Store opened packages of meat sliced at a local deli no longer than 3 to 5 days in the refrigerator.

Smell the glove: Americans don’t understand food date labels and surveys still suck

Note to journalists (if there are any left): Don’t reprint PR fluff like it’s news and don’t bury the lede.

“A good way to test your food is also a simple way: give it a sniff,” says Roni Neff, PhD. “If the date says ‘best by’ and it looks and smells okay, it’s probably okay to eat.”

Probably is not good enough, and smell is a lousy indicator of food safety.

A new survey examining U.S. consumer attitudes and behaviors related to food date labels found widespread confusion, leading to unnecessary discards, increased waste and food safety risks. The survey analysis was led by researchers at the Johns Hopkins Center for a Livable Future (CLF), which is based at the Johns Hopkins Bloomberg School of Public Health.

This study calls attention to the issue that much food may be discarded unnecessarily based on food safety concerns, though relatively few food items are likely to become unsafe before becoming unpalatable. Clear and consistent date label information is designed to help consumers understand when they should and should not worry.

Among survey participants, the research found that 84 percent discarded food near the package date” occasionally” and 37 percent reported that they “always” or “usually” discard food near the package date. Notably, participants between the ages of 18 to 34 were particularly likely to rely on label dates to discard food. More than half of participants incorrectly thought that date labeling was federally regulated or reported being unsure. In addition, the study found that those perceiving labels as reflecting safety and those who thought labels were federally regulated were more willing to discard food.

New voluntary industry standards for date labeling were recently adopted. Under this system, “Best if used by” labels denote dates after which quality may decline but the products may still be consumed, while “Use by” labels are restricted to the relatively few foods where safety is a concern and the food should be discarded after the date. Previously, all labels reflected quality and there was no safety label.

Neff and colleagues found that among labels assessed, “Best if used by” was most frequently perceived as communicating quality, while “use by” was one of the top two perceived as communicating safety. But many had different interpretations.

Lead author, Roni Neff, PhD, who directs the Food System Sustainability Program with the CLF and is an assistant professor with the Bloomberg School’s Department of Environmental Health and Engineering said, “The voluntary standard is an important step forward. Given the diverse interpretations, our study underlines the need for a concerted effort to communicate the meanings of the new labels. We are doing further work to understand how best to message about the terms.”

How best to message about the terms? Maybe use language properly.

Using an online survey tool, Neff and colleagues from Harvard University and the National Consumers League assessed the frequency of discards based on date labels by food type, interpretation of label language and knowledge of whether date labels are regulated by the federal government. The survey was conducted with a national sample of 1,029 adults ages 18 to 65 and older in April of 2016. Recognizing that labels are perceived differently on different foods, the questions covered nine food types including bagged spinach, deli meats and canned foods.

When consumers perceived a date label as an indication of food safety, they were more likely to discard the food by the provided date. In addition, participants were more likely to discard perishable foods based on labels than nonperishables.

But dates can be a lousy indicator: I’ve got deli meat in the fridge with a use by label about 2 weeks from now, yet once that package is opened, the stuff is good for 2-4 days. Publix gets it right.

Smell, like color, is a lousy indicator of food safety.

Food Safety Talk 176: Bug Book

The show opens with a discussion about privacy, whether you should cover the microphone on your computer, or how you can scare your kids using Alexa. The guys talked briefly about what they’re watching, Ben’s trip to Athens Georgia, and celebrity feet. From there the show moves into listener feedback talking about the safety of eating Canadian seaweed. Listener feedback makes a interesting segue into failure, and the things we can learn from it. The show returns to listener feedback with a discussion about citrus safety and infused water. For some reason Don wants to talk about smoke detectors, before returning again to listener feedback and “Contamination Corner”, and ways to learn about stuff you don’t know about (like filibusters). Ben and Don talk about an interview that Don did for Cooking Light, before Don wants to talk about fixing his broken software. Ben ends the show with a long discussion regarding safe cooking directions for frozen vegetables, and why no one can agree.

This episode is available at foodsafetytalk.com or on iTunes.

 

Show notes so you can follow along at home are below:

Listeria happens in lotsa folks, and not pretty

Listeria monocytogenes is a foodborne pathogen that disproportionally affects pregnant females, older adults, and immunocompromised individuals. Using U.S. Foodborne Diseases Active Surveillance Network (FoodNet) surveillance data, we examined listeriosis incidence rates and rate ratios (RRs) by age, sex, race/ethnicity, and pregnancy status across three periods from 2008 to 2016, as recent incidence trends in U.S. subgroups had not been evaluated. The invasive listeriosis annual incidence rate per 100,000 for 2008–2016 was 0.28 cases among the general population (excluding pregnant females), and 3.73 cases among pregnant females.

For adults ≥70 years, the annual incidence rate per 100,000 was 1.33 cases. No significant change in estimated listeriosis incidence was found over the 2008–2016 period, except for a small, but significantly lower pregnancy-associated rate in 2011–2013 when compared with 2008–2010. Among the nonpregnancy-associated cases, RRs increased with age from 0.43 (95% confidence interval: 0.25–0.73) for 0- to 14-year olds to 44.9 (33.5–60.0) for ≥85-year olds, compared with 15- to 44-year olds. Males had an incidence of 1.28 (1.12–1.45) times that of females. Compared with non-Hispanic whites, the incidence was 1.57 (1.18–1.20) times higher among non-Hispanic Asians, 1.49 (1.22–1.83) among non-Hispanic blacks, and 1.73 (1.15–2.62) among Hispanics. Among females of childbearing age, non-Hispanic Asian females had 2.72 (1.51–4.89) and Hispanic females 3.13 (2.12–4.89) times higher incidence than non-Hispanic whites. We observed a higher percentage of deaths among older patient groups compared with 15- to 44-year olds.

This study is the first characterizing higher RRs for listeriosis in the United States among non-Hispanic blacks and Asians compared with non-Hispanic whites. This information for public health risk managers may spur further research to understand if differences in listeriosis rates relate to differences in consumption patterns of foods with higher contamination levels, food handling practices, comorbidities, immunodeficiencies, health care access, or other factors.

Differences among incidence rates of invasive Listeriosis in the U.S. FoodNet population by age, sex, race/ethnicity, and pregnancy status, 2008–2016

Pohl, A. M., Pouillot, R., Bazaco, M. C., Wolpert, B. J., Healy, J. M., Bruce, B. B., . . . Doren, J. M. (2019).

doi:10.1089/fpd.2018.2548

https://www.liebertpub.com/doi/full/10.1089/fpd.2018.2548

3 sick: Another outbreak of listeriosis likely associated with prepackaged caramel apples

On December 1, 2017, PulseNet, the U.S. Centers for Disease Control’s molecular subtyping network for foodborne disease surveillance, identified a cluster of three Listeria monocytogenes clinical isolates with indistinguishable pulsed-field gel electrophoresis (PFGE) pattern combinations. These isolates were closely related to one another by whole-genome multilocus sequence typing within three allele differences (range = 0–3 alleles), indicating that the infections were likely from the same source.

CDC, the Food and Drug Administration (FDA), and state and local health departments initiated a multistate investigation. An outbreak case of listeriosis was defined as an infection with L. monocytogenes, with an isolate that was indistinguishable by PFGE and closely related by whole-genome multilocus sequence typing to the outbreak strain isolated during October–December 2017.

The cases corresponding to the three isolates were identified in Illinois, Iowa, and Michigan. Isolation dates ranged from October 15, 2017, to October 29, 2017. Patients ranged in age from 55 to 71 years (median = 69 years), and all three patients were male. All patients were hospitalized for listeriosis; no deaths were reported. PulseNet was queried routinely for new isolate matches during the investigation, and no additional cases were identified.

Interviews were conducted with all three patients or their surrogates using the standard Listeria Initiative questionnaire (1), which asks about a variety of foods consumed in the month preceding illness onset. Grocery store receipts were collected for the patient in Michigan. Review of reported exposures indicated that all three patients had consumed prepackaged caramel apples purchased from retail establishments in the month preceding illness onset. A case-case analysis was performed comparing exposure frequencies for all food items included in the Listeria Initiative questionnaire for the three outbreak-associated cases with exposure frequencies for 186 sporadic cases of listeriosis from the same states reported to CDC since 2006. Caramel apple consumption was significantly higher among patients included in the outbreak, compared with that among patients with sporadic illnesses (odds ratio = 21.7; 95% confidence interval = 2.3–infinity). None of the interviewed patients had leftover caramel apples in their home for testing.

State and local officials collected records at two of the three retail locations where caramel apples had been purchased. All three retailers sold the same brand of caramel apples (brand A). The product was packaged in a plastic clamshell containing three caramel apples, each on a stick. Caramel apples were seasonal products that were only available for a short period in the fall at two of the retail locations. However, the retail location where the Illinois patient purchased caramel apples had the product in stock at the time of the investigation. Eight packages of caramel apples were collected for testing by the Illinois Department of Public Health, but L. monocytogenes was not detected in any samples. It was not known whether the tested caramel apples were from the same lots as those consumed by the ill persons in this outbreak.

During an inspection at the caramel apple production facility, FDA reviewed records and practices and collected environmental samples for testing. No significant food safety concerns were observed. None of the environmental swabs yielded L. monocytogenes. Environmental swabs collected at a single whole apple supplier yielded L. monocytogenes, but it was not the outbreak strain. Traceback activities did not implicate a specific lot or supplier of whole apples used in brand A caramel apple production during the period of interest.

No additional outbreak-associated illnesses were identified during the investigation. In light of the limited shelf life of the product (reported by the production facility to be 15 days), it was unlikely that caramel apples consumed by ill persons in this outbreak would have still been available for purchase or in persons’ homes at the time of the investigation. Because there was no evidence to suggest an ongoing risk to the public, no public warning was issued by federal or state agencies.

Although the outbreak strain of L. monocytogenes was not isolated from caramel apples or their production environment, the epidemiologic evidence indicated that caramel apples were the suspected vehicle in this outbreak. All outbreak-associated ill persons consumed a specific brand of a relatively uncommon food product in the month before their illness onset, and all were infected with indistinguishable L. monocytogenes strains. Caramel apples were previously implicated in a large multistate outbreak of listeriosis during 2014–2015, caused by contamination of whole apples (2). Ready-to-eat food processors, including those that make caramel apples, could consider the introduction and persistence of L. monocytogenes in food production environments as a potential hazard and mitigate that risk through appropriate environmental monitoring and preventive controls (3). Further research into the control of L. monocytogenes in fresh produce, including fresh apples, might help identify prevention strategies to reduce or eliminate the pathogen in some ready-to-eat foods.

 

Notes from the field: Outbreak of listeriosis likely associated with prepackaged caramel apples

25.jan.19

CDC

Jessica R. Marus, MPH1; Sally Bidol, MPH2; Shana M. Altman3; Oluwakemi Oni, MPH4; Nicole Parker-Strobe, MPH2; Mark Otto, MSPH5; Evelyn Pereira, MPH5; Annemarie Buchholz, PhD5; Jasmine Huffman1,6; Amanda R. Conrad, MPH1; Matthew E. Wise, PhD1 

https://www.cdc.gov/mmwr/volumes/68/wr/mm6803a5.htm

1Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, CDC; 2Michigan Department of Health and Human Services; 3Illinois Department of Public Health; 4Iowa Department of Public Health; 5Food and Drug Administration, Silver Spring, Maryland; 6Oak Ridge Institute for Science and Education, Oak Ridge, Tennessee.

All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.