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Surveying the Phthalate Litigation Risk to Food Companies

By Kara McCall, Stephanie Stern
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Boxed macaroni and cheese—comforting, easy, and, according to a 2017 article by The New York Times, containing “high concentrations” of “[p]otentially harmful chemicals.” Roni Caryn Rabin, The Chemicals in Your Mac and Cheese, N.Y. TIMES, June 12, 2017. Those “chemicals” referenced by the Times are phthalates—versatile organic compounds that have been the focus of increased media, advocacy, and regulatory scrutiny. But what are phthalates and what is the litigation risk to food companies who make products that contain trace amounts of this material?

Background

Phthalates are a class of organic compounds that are commonly used to soften and add flexibility to plastic.1 Ninety percent of phthalate production is used to plasticize polyvinyl chloride (PVC).2 Di-(2-ethylhexl) phthalate (DEHP) is the most commonly used phthalate plasticizer for PVC.3 Due to the prevalence of plastics in the modern world, phthalates are everywhere—from food packaging to shower curtains to gel capsules. Consequently, almost everyone is exposed to phthalates almost all of the time and most people have some level of phthalates in their system.4

Recently, various epidemiological studies have purported to associate phthalates with a range of different injuries, from postpartum depression to obesity to cancer. However, as the Agency for Toxic Substances and Disease Registry (ATSDR) stated in its 2019 toxicology profile for DEHP, these epidemiology studies are flawed because, inter alia, they often rely on spot urine samples to assess exposure, which does not provide long-term exposure estimates or consider routes of exposure.5 To date, claims regarding the effects of low-level phthalate exposure on humans are not supported by human toxicology studies. Instead, phthalate toxicology has only been studied in animals, and some phthalates tested in these animal studies have demonstrated no appreciable toxicity. Two types of phthalates—DBP and DEHP—are purported to be endocrine disrupting (i.e., affecting developmental and reproductive outcomes) in laboratory animals, but only when the phthalates are administered at doses much higher than those experienced by humans.6 Indeed, there is no causal evidence linking any injuries to the low-level phthalate exposure that humans generally experience. Nonetheless, advocacy and government groups have extrapolated from these animal studies to conclude that DEHP may possibly adversely affect human reproduction or development if exposures are sufficiently high.7 Indeed, in the past two decades, a number of regulatory authorities began taking steps to regulate certain phthalates. Most notably:

  • In 2005, the European Commission identified DBP, DEHP, and BBP as reproductive toxicants (Directive 2005/84/EC), and the European Union banned the use of these phthalates as ingredients in cosmetics (Directive 2005/90/EC).
  • In 2008, Congress banned the use of DBP, DEHP, and BBP in children’s toys at concentrations higher than 0.1%. See 15 U.S.C. § 2057c.
  • The EU added four phthalates (BBP, DEHP, DBP, and DIBP) to the EU’s list of Substances of Very High Concern (SVHCs) and, subsequently, to its Authorization List, which lists substances that cannot be placed on the market or used after a given date, unless authorization is granted for specific uses. BBP, DEHP, DBP, and DIBP were banned as of February 21, 2015, except for the use of these phthalates in the packaging of medicinal products.
  • In 2012, the FDA issued a statement discouraging the use of DBP and DEHP in drugs and biologic products. At the time, the agency said that these phthalates could have negative effects on human endocrine systems and potentially cause reproductive and developmental problems.8

More recently, phthalate exposure through food has become a trending topic among consumer advocates. Phthalates are not used in food, but can migrate into food through phthalates-containing materials during food processing, storing, transportation, and preparation. Certain studies report that ingestion of food accounts for the predominant source of phthalate exposure in adults and children. However, in assessing DEHP, the ATSDR noted that the current literature on “contamination of foodstuffs comes from outside the United States or does not reflect typical exposures of U.S. consumers; therefore, it is uncertain whether and for which products this information can be used in U.S.-centered exposure and risk calculations.”9 Further, the concentration of phthalates found in food are very low-level—multiples lower than the doses used in animal toxicology studies.10

In 2017, a study published on the advocacy site “kleanupkraft.org” stated that phthalates were detected in 29 of 30 macaroni and cheese boxes tested.11 The study notes that “DEHP was found most often in the highest amounts.” Notably, however, the “amounts” are provided without any context, likely because there is no universally accepted threshold of unsafe phthalate consumption. Thus, although the boxed macaroni and cheese study found “that DEHP, DEP, DIBP, and DBP were frequently detected in the cheese items tested,” and “[t]he average DEHP concentration was 25 times higher than DBP, and five times higher than DEP,” none of this explains whether these numbers are uniquely high and/or dangerous to humans. Meanwhile, on December 10, 2019, the European Food Safety Authority announced an updated risk assessment of DBP, BBP, DEHP, DINP, and DIDP, and found that current exposure to these phthalates from food is not of concern for public health.12

Phthalate Litigation

For years, phthalates in food have been targeted by environmental groups seeking to eliminate use of phthalates in food packaging and handling equipment. Most recently, several lawsuits were filed against boxed macaroni and cheese manufacturers alleging misrepresentation and false advertising due to their undisclosed alleged phthalate contamination. See, e.g., McCarthy, et al. v. Annie’s Homegrown, Inc., Case No. 21-cv-02415 (N.D. Cal. Apr. 2, 2021). Perhaps acknowledging that the amounts contained in the food packages have not been shown to present any danger, these claims are being pursued as consumer fraud claims based on failure to identify phthalates as an ingredient, rather than as personal injury claims.

Besides this recent litigation, however, there has been a notable dearth of phthalate litigation. This is likely due to several factors: First, in general, courts have rejected false claim lawsuits involving trace amounts of a contaminant chemical. See, e.g., Tran v. Sioux Honey Ass’n, Coop., 471 F. Supp. 3d 1019, 1025 (C.D. Cal. 2020) (collecting cases). For example, in Axon v. Citrus World, Inc., 354 F. Supp. 3d 170 (E.D.N.Y. 2018), the Court dismissed plaintiff’s claim that the use of the word “natural” constituted false advertising because the product contained trace amounts of weed killer. Id. at 182–84. The Court based this dismissal, in part, on the fact that the trace amounts of the commonly used pesticide was “not an ‘ingredient’ added to defendant’s products; rather, it is a substance introduced through the growing process.” Id. at 183. Similarly, phthalate is not an intentionally added ingredient—instead, it is a substance introduced, if at all, in trace amounts at various points throughout the manufacturing, handling, and packaging process. Second, proving that phthalate exposure from a particular food item caused an alleged injury would be extremely difficult. As mentioned above, there is no direct scientific evidence linking low-level phthalate exposure in humans to reproductive problems, cancer, or any other injury. Instead, plaintiffs must rely on animal studies where the subject, most commonly a rat, was exposed to enormous amounts of phthalates, many multiples of the amount that would be found in food. Moreover, the pervasive nature of phthalates makes it difficult to pinpoint any particular product as the source of the injury. If every food item a plaintiff ever consumed has been touched by a phthalate-containing material, it seems near impossible to prove that one particular food caused the alleged injury.

Although phthalate litigation has thus far proven unpopular, this landscape could change in the near future due to increased regulatory scrutiny. On December 20, 2019, the EPA stated that DEHP, DIBP, DBP, BBP, and dicyclohexyl phthalate were five of 20 high-priority chemicals undergoing risk evaluation pursuant to the Toxic Substances Control Act.13 The categorization of these phthalates as high-priority initiates a three- to three-and-a-half-year risk evaluation process, which concludes in a finding of whether the chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use.14 Although the same causation and product identification issues will remain, a revised risk analysis by the EPA may lead to increased phthalate litigation.

The views expressed in this article are exclusively those of the authors and do not necessarily reflect those of Sidley Austin LLP and its partners. This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.

References

  1. The most commonly used phthalates are di-(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), benzyl butyl phthalate (BBP), di-n-butyl phthalate (DBP), and diethyl phthalate (DEP). See Angela Giuliani, et al., Critical Review of the Presence of Phthalates in Food and Evidence of Their Biological Impact, 17 INT. J. ENVIRON. RES. PUBLIC HEALTH 5655 (2020).
  2. COWI A/S, Data on Manufacture, Import, Export, Uses and Releases of Dibutyl Phthalate (DBP), As Well As Information on Potential Alternatives To Its Use 10-11 (Jan. 29, 2009). http://echa.europa.eu/documents/10162/
    13640/tech_rep_dbp_en.pdf (observing European Council for Plasticizers and Intermediates (ECPI)); Agency for Toxic Substances & Disease Registry, DI-n-BUTYL PHTHALATE, Production, Import/Export, Use, and Disposal (Jan. 3, 2013). http://www.atsdr.cdc.gov/ToxProfiles/tp135-c5.pdf; Peter M. Lorz, et al., Phthalic Acid and Derivatives. ULLMANN’S ENCYCLOPEDIA OF INDUSTRIAL CHEMISTRY (Wiley-VCH: Weinheim, 2000); Lowell Center for Sustainable Production, Phthalates and Their Alternatives: Health and Environmental Concerns 4 (Jan. 2011). https://www.sustainableproduction.org/downloads/PhthalateAlternatives-January2011.pdf.
  3.  Michael D. Shelby, NTP-CERHER Monograph on the Potential Human Reproductive and Developmental Effects of Di (2-Ethylhexyl) Phthalate (DEHP). National Toxicology Program, HHS. NIH Publication No. 06-4476 at 2–3 (Nov. 2006).
  4.  See Chris E. Talsness, et al., Components of Plastic: Experimental Studies in Animals and Relevance for Human Health, 364 PHIL. TRANS. R. SOC. B 2079, 2080 (2009). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873015/pdf/rstb20080281.pdf.
  5. Agency for Toxic Substances & Disease Registry, Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP), Draft for Public Comment 3 (Dec. 2019). https://www.atsdr.cdc.gov/toxprofiles/tp9.pdf.
  6. FDA Guidance for Industry, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
  7. NIH Publication No. 06-4476 at 2–3, supra n.3.
  8. FDA Guidance for Industry. Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
  9. Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP) at 362, supra n.5.
  10. Compare id. at 5 (measuring effects of phthalate oral exposure in mg/kg/day) with Samantha E. Serrano, et al., Phthalates and diet: a review of the food monitoring and epidemiology data, 13 ENVIRON. HEALTH 43 (2014) (measuring phthalate concentration in food in μg/kg).
  11. Testing Finds Industrial Chemical Phthalates in Cheese, Coalition for Safer Food Processing and Packaging. http://kleanupkraft.org/data-summary.pdf.
  12. FAQ: phthalates in plastic food contact materials. European Food Safety Authority. (Dec. 10, 2019).
  13. EPA Finalizes List of Next 20 Chemicals to Undergo Risk Evaluation under TSCA. U.S. Environmental Protection Agency. (Dec. 20, 2019).
  14.  Risk Evaluations for Existing Chemicals under TSCA. U.S. Environmental Protection Agency.
Recall

JBS Recalls Nearly 5000 Pounds of Imported Australian Boneless Beef Due to Potential E. Coli Contamination

By Food Safety Tech Staff
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Recall
JBS Boneless Beef product
Label of recalled JBS Australia beef product. (Image from FSIS)

JBS USA Food Company is recalling about 4,860 pounds of imported raw and frozen boneless beef products over concern of contamination with E. coli O157:H7. The products were imported on or around November 10, 2020 and shipped to distributors and processors in New York and Pennsylvania.

The issue was uncovered during routine product sampling collected by FSIS, which confirmed positive for the presence of E. coli O157:H7, according to an FSIS announcement. “FSIS is concerned that some product may be frozen and in cold storage at distributor or further processor locations,” the announcement stated. “Distributors and further processors who received these products are urged not to utilize them.”

No illnesses or adverse reactions have been reported.

FDA

FDA’s ‘Closer to Zero’ Action Plan to Reduce Exposure to Toxic Elements in Baby Food

By Food Safety Tech Staff
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FDA

Following the report released by Congress in February regarding an alarming amount of toxic heavy metals found in baby food, the FDA has released an action plan that aims to reduce the presence of those dangerous metals to the “lowest possible levels” in common foods consumed by babies and young children. The “Closer to Zero” plan takes research, regulatory and outreach into consideration and will use the following approach:

  • Evaluating the scientific basis for action levels. FDA will evaluate existing data from routine testing of food, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
  • Proposing action levels for specific toxic elements in baby food categories that include cereal, formula, and pureed fruits and vegetables.
  • Working with stakeholders and federal partners on proposed action levels— including collecting data and information from workshops and scientific meetings—and assessing the feasibility of the proposed action levels and timeframes for achieving them. The FDA will use and monitor the information to finalize the action levels.

“Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children,” stated Janet Woodcock, M.D., acting FDA commissioner and Susan Mayne, Ph.D., director of CFSAN. “During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan.” Phase 2 runs from April 2022 until April 2024 and will expand the agency’s work into cadmium and mercury, as well as finalize action levels for lead. Phase three and beyond begins in April 2024 and will finalize action levels for arsenic.

FDA

FDA Publishes Report on Fall 2020 E. Coli Outbreak in Leafy Greens

By Food Safety Tech Staff
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FDA

Today the FDA released a report on its investigation into the E. coli O157:H7 outbreak involving leafy greens during the Fall 2020. The report also identified three reoccurring trends in the contamination of leafy greens grown in the Central Coast of California related to the outbreak strain, region and issues with activities on adjacent land.

In January, FDA released preliminary findings, which linked cattle feces to the outbreak strain—located uphill from where contaminated leafy greens were grown.

“In the investigation, the FDA recommends that growers of leafy greens in the California Central Coast Growing Region consider this reoccurring E. coli strain a reasonably foreseeable hazard, and specifically of concern in the South Monterey County area of the Salinas Valley,” stated Frank Yiannas, deputy commissioner for food policy and response, in an agency news release. “It is important to note that farms covered by the Food Safety Modernization Act (FSMA) Produce Safety Rule are required to implement science and risk-based preventive measures in the rule, which includes practices that prevent the introduction of known or reasonably foreseeable hazards into or onto produce.”

The 2021 Food Safety Consortium Virtual Conference Series kicks off on May 6 with a keynote address from Frank Yiannas, deputy commissioner of food policy and response at FDA The FDA also recommends that the region’s agricultural community work to determine where the reoccurring strain of the pathogenic E. coli is persisting, along with the probable contamination route(s).

“Although the FDA is keenly focused on taking steps to help mitigate recurring leafy green contamination events, we alone cannot fix this issue. Industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community is critical to reducing foodborne illnesses,” Yiannas stated. “At the FDA, the safety of leafy greens remains a top priority, and we are committed to working with all stakeholders to address this significant public health issue and further protect consumers.”

The Report, “Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli O157:H7”, can be downloaded from FDA’s website.

Recall

Sabra Recalls Hummus After Salmonella Discovered During FDA Routine Screening

By Food Safety Tech Staff
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Recall

On Monday Sabra Dipping Company, LLC and the FDA announced a voluntary recall of the company’s Classic Hummus due to potential Salmonella contamination. The discovery was made when the FDA conducted a routine screen of one tub. Sabra has recalled about 2100 cases of its 10 oz Classic Hummus (1 SKU), which was produced on February 10 and has a “Best Before” date of April 26. The product was distributed to 16 states, but according to the company announcement posted on FDA’s website, since the hummus is more than halfway through its shelf life, “it’s unlikely you’ll find this product on the shelf.”

Thus far no illnesses have been reported in connection with this recall.

Olga Pawluczyk, P&P Optica
FST Soapbox

Assessing Detection Systems to Make Food Safer

By Olga Pawluczyk
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Olga Pawluczyk, P&P Optica

It is an exciting time to be in the food industry. Consumers are ever more aware of what they are eating and more demanding of quality. And the vital need to reduce global food waste is transforming how we produce and consume food. This is driving innovation all the way along the supply chain, from gate to plate.

One of the biggest areas of opportunity for the industry to increase automation and improve food safety is in the processing plant. The challenges processors have faced in the last 12 months have accelerated the focus on optimizing resources and the drive for more adoption of new technology.

Foreign material contamination is a growing issue in the meat industry and new types of detection systems are emerging to help address this challenge. As Casey Gallimore, director of regulatory and scientific affairs at the North American Meat Institute, highlighted in a recent webinar, 2019 was a record year for the number of recalls related to foreign object contamination, which totaled 27% of all FSIS recalls in that year.

“There are a number of potential reasons why recalls due to foreign object contamination have increased over the years: Greater regulatory focus, more discerning consumers, [and] more automation in plants. But one important reason for this trend is that we have a lot of new technology to help detect more, [but] we are not necessarily using it to its full potential,” said Gallimore. “As an industry, we have a strong track record of working together to provide industry-wide solutions to industry-wide problems. And I believe that education is key to understanding how different detection systems—often used together—can increase the safety and quality of our food.”

Types of Detection Systems

Processors use many different detection systems to find foreign materials in their products. Equipment such as x-rays and metal detectors, which have been used for many years, are not effective against many of today’s contaminants: Plastics, rubber, cardboard and glass. And even the most well trained inspectors are affected by fatigue, distraction, discomfort and many other factors. A multi-hurdle approach is imperative, and new technologies like vision systems need to be considered.

Vision systems, such as cameras, multi-spectral, and hyperspectral imaging systems can find objects, such as low-density plastics, that may have been missed by other detection methods. Yet, depending on the system, their performance and capabilities can vary widely.

Camera-based systems are the most similar to the human eye. These systems are good for distinguishing objects of varying size and shape, albeit in two-dimensions rather than three. But they become less effective in situations with low contrast between the background and the object being detected. Clear plastics are a good example of this.

Multi-spectral systems are able to see more colors, including wavelengths outside of the visible spectrum. However, multispectral systems are set up to use only specific wavelengths, which are selected based on the materials that the system is expected to detect. That means that multispectral systems can identify some chemical as well as visual properties of materials, based on those specific wavelengths. It also means that other materials, which the system has not been designed to find, will likely not be detected by a multispectral system.

Another relatively new type of vision system uses hyperspectral imaging. These systems use chemistry to detect differences in the materials being inspected and therefore recognize a broad range of different contaminants. They are especially good at seeing objects that cameras or human inspectors may miss and at identifying the specific contaminant that’s been detected. The same system can assess quality metrics such as composition and identify product flaws such as woody breast in chicken. Hyperspectral systems also gather tremendous amounts of chemistry data about the products they are monitoring and can use artificial intelligence and machine learning to get a more holistic picture of what is happening in the plant over time, and how to prevent future contamination issues. This might include identifying issues with a specific supplier, training or other process challenges on one line (or in one shift), or machinery in the plant that is causing ongoing contamination problems.

Many processors are considering implementing new inspection systems, and are struggling to understand how to compare the expected performance of different systems. One relatively simple methodology that can be used to evaluate system performance is, despite its simplicity, called a “Confusion Matrix”.

The Confusion Matrix

A confusion matrix is often used in machine learning. It compares the expected outcome of an event with the actual outcome in order to understand the reliability of a test.

Figure 1 shows four possible outcomes for any kind of test.

Actual (True Condition)

Predicted

(Measured Outcome)

Positive (P) Negative (N)
Positive Detection True Positives (TP) False Positives (FP)
Negative Detection False Negatives (FN) True Negatives (TN)
P = TP + FN N = FP + TN
Figure 1. Confusion Matrix

But what does a confusion matrix tell us, and how can it help us assess a detection system?

The matrix shows us that a detection system may incorrectly register a positive or negative detection event—known as a ‘False Positive’ or ‘False Negative’.

As an example, say we are testing for a disease such as COVID-19. We want to know how often our system will give us a True Positive (detecting COVID when it *IS* present) versus a False Positive (detecting COVID when it *IS NOT* present).

Let’s apply this to processing. If you are using an x-ray to detect foreign objects, a small piece of plastic or wood would pass through unnoticed. This is a False Negative. By contrast, a system that uses hyperspectral imaging would easily identify that same piece of plastic or wood, because it has a different chemical signature from the product you’re processing. This is a True Positive.

A high rate of false negatives—failing to identify existing foreign materials—can mean contaminated product ends up in the hands of consumers.

The other side of the coin is false positives, meaning that the detector believes foreign material to be present when in fact it is not. A high rate of False Positives can lead to significant and unnecessary product wastage, or in time lost investigating an incident that didn’t actually occur (see Figure 2).

True Positives and False Positives
Figure 2. Balance of True Positives and False Positives

The secret to a good detection system lies in carefully balancing the rates of true positives and false positives by adjusting the sensitivity of a system.

This is where testing comes in. By adjusting a system and testing under different conditions, and then plotting these outcomes on the confusion matrix, you get an accurate picture of the system’s performance.

Effectiveness of a Detector

Detection is not just the act of seeing. It is the act of making a decision based on what you have seen, by understanding whether something of importance has occurred. Many factors influence the effectiveness of any detection system.

Resolution. This is the smallest size of object that can possibly be detected. For example, when you look at a photograph, the resolution affects how closely you can zoom in on an image before it becomes blurry.

Signal to noise ratio. This measures the electronic “noise” of the detector and compares it with the “background noise” that may interfere with the signals received by the detector. Too much background noise makes it harder to identify a foreign object.

Speed of acquisition. This measures how fast the detector can process the signals it receives. Motion limits what you can see. As line speeds increase, this impacts what detectors are able to pick up.

Material being detected. The type of material being detected and its properties will have a significant impact on the likelihood of detection. As previously mentioned, for example, x-rays are unlikely to detect low-density materials such as cardboard, resulting in a high number of False Negatives.

Presentation or location of material being detected. Materials that are underneath another object, that are presented on an angle, are too similar to the product being inspected, or are partially obstructed may be more difficult for some detectors to find. This also presents a risk of False Negatives.

Complexity of the product under inspection. Product composition and appearance vary. For example, just like the human eye, finding a small object on a uniformly illuminated and uniform color background like a white kitchen floor is much easier than finding the same small object on a complex background like industrial carpet. Coarsely ground meat might be more difficult to detect than uniform back fat layers, for example.

Environment. Conditions such as temperature and humidity will have a significant effect on detection.

Detection Curves

To understand system performance even better, we can use a detection curve. This plots out the likelihood of detection against different variables (e.g., object size) and allows us to objectively compare how these different factors impact the performance of each system.

Figure 3 shows how this looks when plotted as a curve, with object size on the x-axis (horizontal) and the probability of detection (a True Positive from the Confusion Matrix) on the y-axis (vertical). It shows three examples of possible detection curves, depending on the detector being used.

Detection curves
Figure 3. Examples of detection curves for different detectors. Probability of detection of an object increases as the size of the object increases.

A detection curve tells you both the smallest and largest object that a detector will find and the probability that it will be found.

In the example presented by Figure 3, Detector 3 can see essentially 100% of large and very large objects, as can Detector 2. But Detector 3 is also more likely than the other two systems in the example to see microscopic objects. Based on this detection curve it would likely be the best option if the goal were to detect as many foreign objects as possible, of all sizes.

Of course, the performance of a detector is determined by multiple measures, not just size,

Detection capability can be improved for most detection systems, but typically comes at a significant cost: Increasing sensitivity will increase the number of false positives, resulting in increased product rejection. This is why looking at the detection curve together with the false-positive/false-negative rates for any detection system gives us a clear picture of its performance and is invaluable for food processing plants when selecting a system.

Using the confusion matrix and a detection curve, processors can compare different detection systems on an apples-to-apples basis. They can easily see whether a system can identify small, tiny or microscopic objects and, crucially, how often it will identify them.

Every detection method—X -ray, metal detection, vision systems, manual inspection—presents a trade-off between actual (correct) detection, rejection of good product (false positive) and missed detections (false negative). This simple way to compare differences means processors can make the right decision for the specific needs of their plant, based on easily gathered information. For all of us data geeks out there, that sounds like the Holy Grail.

Deane Falcone, CropOne
FST Soapbox

E. Coli on the Rise: Lettuce Explain

By Deane Falcone, Ph.D.
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Deane Falcone, CropOne

The CDC estimates that 48 million people in the United States become sick with a foodborne illness each year. Some of the most common of these illnesses include norovirus, Salmonella, and E. coli. Each can result in a range of symptoms, from mild discomfort to serious, life-threatening illnesses. Although the coronavirus pandemic has worked to create a sense of heightened public health awareness, one of these common, yet preventable, foodborne illnesses—E. coli—is still on the rise.

What Is E. coli and How Common Are Infections?

According to the CDC, Escherichia coli (E. coli) are a large and diverse group of bacteria found in the environment, foods, and intestines of people and animals. Most strains of the bacteria are harmless, but certain ones can make you sick, causing diarrhea, urinary tract infections, respiratory illness and pneumonia, or other illnesses.

When it comes to understanding the scale of the problem, upwards of 70,000 Americans are estimated to fall ill because of E. coli each year, thousands of whom require hospitalization. E. coli outbreaks have been occurring with regularity, and the number of cases are increasing instead of slowing down, in frequency. In November 2020 alone, there were three ongoing E.coli outbreaks in the United States, accounting for 56 infections, 23 hospitalizations, and one death. At least one of these outbreaks stemmed from a common target for the bacteria: Romaine lettuce. When it comes to E. coli-contaminated foods, fresh leafy greens such as romaine or spinach are the most common vehicles for E. coli that can pose serious risks to human health.

Leafy Greens: An Ideal Target

Leafy greens are an easy target for E. coli for a number of reasons, the first being their popularity. The public recognition of the health value of consuming greater amounts of fresh leafy greens has correspondingly increased the production area of such produce to meet consumer demand. Crop production over wider areas makes tracking of contamination in the field more difficult and the greater consumption increases chances of eating contaminated leafy greens. This type of produce also grows low to the ground, increasing chances of exposing the edible, leafy portions of the lettuce to contaminated water. Finally, other vegetables are often cooked prior to consumption, killing the bacteria, whereas romaine and other leafy greens are often consumed raw.

Once this type of produce is exposed to contaminants, several characteristics of leaf surfaces make removal of bacteria such as E. coli difficult. Studies have shown that, at the microscopic level, the “roughness” or shape of the leaf surface can influence the degree to which bacteria adheres to leaves. Bacteria have specific protein fibers on their surface that are involved in the attachment of the bacteria to the leaf surface and this has been shown to be dependent on the surface roughness of the leaf. Other factors include the “pores” on leaf surfaces—stomata—through which plants take up carbon dioxide and release oxygen and water vapor. Pathogenic E. coli has been observed to enter such stomatal pores and therefore is often very resistant to removal by washing. Moreover, the density of stomata within leaves can vary between different varieties of lettuce or spinach and so affects the degree of E. coli attachment. Additional factors such as leaf age, damage and amount of contaminating bacteria also affect how effectively bacteria adhere to the leaves, making washing difficult.

Are E. Coli Outbreaks Avoidable?

Unfortunately, E. coli outbreaks will likely remain prevalent because of the challenge of interrogating all irrigation water for large and widespread production fields. Once microbial contaminants are present on fresh leafy produce, their complete removal by washing cannot be guaranteed, and it is very difficult to monitor every plot of crops continuously. However, there is a solution to this problem: Controlled environment agriculture (CEA). CEA is an broad term used for many varieties of indoor plant cultivation and can be defined as a method of cultivating plants in an enclosed environment, using technology to ensure optimal growing conditions.

Because outbreaks caused by E. coli-contaminated produce are most often due to produce coming into contact with contaminated irrigation water, indoor growing provides an ideal solution with zero reliance on irrigation water. It also offers a sealed environment with virtually no risk of contamination from animal excrement or other pathogen sources. Indoor farming also makes additional features possible that enhance safety including the use of purified water and handling done only by staff wearing protective clothing (for the plants) including lab coats, hair nets, and gloves. No ungloved hand ever comes into contact with the produce either during growth or in packaging. These standards are nearly impossible to achieve in a traditional farm setting.

Using hydroponic technology enables farming in a clean and contaminant-free, indoor environment. Applying best hygienic practices with this growing model provides safe and clean growth in a sealed, controlled environment, with virtually no risk of illness-causing pathogens.

At this point, not everyone can access food coming from a clean, indoor facility. At the consumer level the best way to avoid E. coli infection remains simply being diligent when it comes to washing. Even if produce is labeled “triple-washed,” if it was grown outdoors, the consumer should always wash it again. Or better yet, look for indoor, hydroponically-grown produce to further mitigate the risk.

Although these outbreaks will continue, as they do, we suspect more consumers will embrace indoor-grown produce and this emerging form of agriculture as a safer alternative. As consumers increasingly understand the advantages of indoor growing, such as enhanced quality and longer shelf life, the popularity of this growth method will increase. Eventually, a greater quantity of the most commonly-infected produce will come from these controlled environments, gradually producing an overall safer and healthier mass product.

Nicole Lang, igus
Retail Food Safety Forum

Robots Serve Up Safety in Restaurants

By Nicole Lang
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Nicole Lang, igus

Perhaps the top takeaway from the worldwide COVID-19 pandemic is that people the world over realize how easily viruses can spread. Even with social distancing, masks and zealous, frequent handwashing, everyone has learned contagions can cycle through the atmosphere and put a person at risk of serious, and sometimes deadly, health complications. In reality, there are no safe spaces when proper protocols are not followed.

The primary culprit in transmission of norovirus, according to the CDC, is contaminated food. “The virus can easily contaminate food because it is very tiny and spreads easily,” the CDC says in a fact sheet for food workers posted on its website. “It only takes a very small amount of virus to make someone sick.”

The CDC numbers are alarming. The agency reports about 20 million people get sick from norovirus each year, most from close contact with infected people or by eating contaminated food. Norovirus is the leading cause of disease outbreaks from contaminated food in the United States, and infected food workers cause about 70% of reported norovirus outbreaks from contaminated food.

The solution to reducing the transmission of unhealthy particles could be starting to take shape through automation. While robots have been used for the past few years in food manufacturing and processing, new solutions take food handling to a new level. Robots are no longer in the back of the house in the food industry, isolated in packaging and manufacturing plants. They are now front and center. The next time you see a salad prepared for you at a favorite haunt, you may be watching a robot.

“The global pandemic has altered the way that we eat,” said Justin Rooney, of Dexai Robotics, a company that developed a food service robotic device. Reducing human contact with food via hands-free ordering and autonomous food serving capabilities has the potential to reduce the spread of pathogens and viruses, and could help keep food fresh for a longer period of time.

Painful Pandemic

Increased use of automation in the foodservice industry might be one of the salvations of the COVID-19 pandemic. In an industry searching for good news, that might be the silver lining in an otherwise gloomful crisis.

Job losses in the restaurant industry have been brutal. By the end of November, nearly 110,000 restaurants in the United States had closed. A report by the National Restaurant Association said restaurants lost three times more jobs than any other industry since the beginning of the pandemic. In December, reports said nearly 17% of U.S. restaurants had closed. Some restaurants clung to life by offering outdoor dining, but as winter set in, that option evaporated. Some governors even demanded restaurant closures as the pandemic escalated in late fall.

Restaurants have faced a chronic labor shortage for years. Despite layoffs during the pandemic, many former foodservice employees are electing to leave the industry.

Teenagers, for instance, and some older workers are staying away for health and safety reasons. Some former workers are also finding out that they can make more money on unemployment benefits than by returning to work. Restaurant chains have hiked wages, but filling positions still remains a challenge.

Automated Solutions

Restaurants began dancing with the idea of robots nearly 50 years ago. The trend started slowly, with customers ordering food directly through kiosks. As of 2011, McDonald’s installed nearly 7,000 touchscreen kiosks to handle cashiering responsibilities at restaurants throughout Europe.

As technology has advanced, so has the presence of robots in restaurants. In 2019 Seattle-based Picnic unveiled a robot that can prepare 300 pizzas in an hour. In January, Nala Robotics announced it would open the world’s first “intelligent” restaurant. The robotic kitchen can create dishes from any cuisine in the world. The kitchen, which is expected to open in April in Naperville, Illinois, will have the capability to create an endless variety of cuisine without potential contamination from human contact.

Dexai designed a new robotic unit that allows for hands-free ordering that can be placed through any device with an Internet connection. The robot also includes a new subsystem for utensils, which are stored in a food bin to keep them temperature controlled. This ensures that robot is compliant with ServSafe regulations. The company is working on improving robot system’s reliability, robustness, safety and user friendliness. The robot has two areas to hold tools, a kitchen display system, bowl passing arm, an enclosure for electronics and two refrigeration units. It has the unique ability to swap utensils to comply with food service standards and prevent contamination as a result of allergens, for example.

Why Automation

Many industries have been impacted by advancements in automation, and the foodservice industry is no different. While initially expensive, the benefits over time can provide to be worth the investment.

One of the most significant advantages, particularly important in the post-COVID era, is better quality control. Automated units can detect issues much earlier in the supply chain, and address those issues.

Automation can also help improve worker safety by executing some of the more repetitive and dangerous tasks. Robots can also boost efficiency (i.e., a robot used for making pizza that can press out dough five times faster than humans and place them into ovens) and eliminate the risk of injury. Robots are also being used to make coffee, manage orders and billing, and prepare the food. Robots can also collect data that will help foodservice owners regarding output, quantity, speed and other factors.

“Alfred’s actions are powered by artificial intelligence,” according to Rooney. “Each time Alfred performs an action, the associated data gets fed into a machine learning model. Consequently, each individual Alfred learns from the accumulated success and failures of every other Alfred that has existed.” Dexai plans to teach the robot to operate other commonly found pieces of kitchen equipment such as grills, fryers, espresso machines, ice cream cabinets and smoothie makers.

Unrelenting Trend

Automated solutions might have come along too late to save many restaurants, but the path forward is clear. While they are not yet everywhere, robots are now in play at significant number of restaurants, and there is no turning back. Any way you slice it, robots in restaurants, clearly, is an idea whose time has come.

El Abuelito Cheese

Recall Alert: Listeria Outbreak Linked to Hispanic-Style Fresh and Soft Cheeses

By Food Safety Tech Staff
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El Abuelito Cheese

–UPDATE March 9, 2021 — Today the FDA confirmed that the recalled cheeses were also distributed to Rhode Island. “States with confirmed distribution now include: AL, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, NE, OH, PA, RI, SC, TN, VA, and WI.”

–UPDATE February 24, 2021 — FDA has expanded its warning related to El Abuelito Cheese to include all cheese branded by the company “until more information is known”.

—END UPDATE—

A multistate outbreak of Listeria monocytogenes has been linked to Hispanic-style fresh and soft cheeses produced by El Abuelito Cheese, Inc. As a result, the company has recalled all Questo Fresco products with sell by dates through March 28 (032821).

Join Food Safety Tech on April 15 for the complimentary Food Safety Hazards Series: Listeria Detection, Mitigation, Control & Regulation“As the FDA stated, about this outbreak investigation, the Connecticut Department of Public Health collected product samples of El Abuelito-brand Hispanic-style fresh and soft cheeses from a store where a sick person bought cheeses. Sample analysis showed the presence of Listeria monocytogenes in samples of El Abuelito Queso Fresco sold in 10 oz packages, marked as Lot A027 with an expiration date of 02/26/2021,” the company stated in an announcement posted on FDA’s website. “Samples are currently undergoing Whole Genome Sequencing (WGS) analysis to determine if the Listeria monocytogenes found in these samples is a match to the outbreak strain. At this time, there is not enough evidence to determine if this outbreak is linked to El Abuelito Queso Fresco.”.

The recalled products were distributed to Connecticut, Maryland, New Jersey, North Carolina, New York, Pennsylvania and Virginia. Thus far seven people, all of whom have been hospitalized, have fallen ill.

FDA recommends that consumers, restaurants and retailers do not consume, sell or serve any of the recalled cheeses. The agency also states that anyone who purchased of received the recalled products use “extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination.”

Mitzi Baum, Stop Foodborne Illness
Food Safety Culture Club

Our Petition to USDA: The Time for Change Is Now

By Mitzi Baum
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Mitzi Baum, Stop Foodborne Illness

On January 25, 2021 Stop Foodborne Illness (STOP), in collaboration with Center for Science in the Public Interest, Consumer Reports, Consumer Federation of America and five STOP constituent advocates filed a petition with USDA Food Safety Inspection Service (FSIS) to reform and modernize poultry inspections. The goal of these reforms is to reduce the incidence of Salmonella and Campylobacter contamination in raw poultry thus drastically decreasing foodborne illnesses due to these pathogens.

According to the CDC, in 2019, these two pathogens combined were responsible for more than 70% of foodborne illnesses in the United States. As Mike Taylor, former FDA Deputy Commissioner for Foods and Veterinary Medicine, shares in his
Op-Ed, the time for change is now as the current regulatory framework is inadequate and has not delivered the desired results of reducing Salmonella and Campylobacter outbreaks.

Today, the USDA’s mark of inspection is stamped on poultry, although birds may exceed the performance standards; there are no clear consequences for establishments that do not meet the current guidelines. Without science-based standards or penalties for non-compliance, the burden of this problem falls upon consumers.

At STOP, we share the voices of consumers whose lives have been altered due to preventable problems such as this. Our constituent advocates share their journeys through severe foodborne illness to share the WHY of food safety. Real people, real lives are impacted when we do not demand action. STOP board member, Amanda Craten, shares her son Noah’s story:

“My toddler suddenly came down with a fever and diarrhea, but it wasn’t until weeks later that I learned that his symptoms, which nearly killed him, were caused by a multi-drug resistant strain of Salmonella.

After being admitted to the hospital, his doctors found abscesses in the front of his brain caused by infection and they were creating pressure on his brain. He underwent surgery and weeks of antibiotic treatments.

My 18-month son was seriously injured and permanently disabled as a result of Salmonella-contaminated chicken.” – Amanda Craten.

Unfortunately, Noah’s story is not rare, which is why Amanda supports this petition for change and has provided a powerful video about Noah’s foodborne disease journey and his life now.

Because there are too many stories like Noah’s, STOP and its partner consumer advocacy organizations want to work with FSIS and industry to:

  1. Develop real benchmarks that focus on reduction of known, harmful pathogens in poultry
  2. Modernize standards to reflect current science
  3. Implement on-farm control measures
  4. Re-envision the standards to focus on the risk to public health

As a new administration begins, capitalizing on this opportunity to modernize poultry inspection that can benefit consumers and the food industry makes sense. STOP and its partners are hopeful that leadership at USDA/FSIS will take this opportunity to create consequential and relevant change. Ultimately, this transformation will reduce the incidence of foodborne illness due to contamination of poultry and increase consumer confidence in the USDA’s mark of inspection. Please comment on this petition.

Have you been impacted by foodborne illness? Tell STOP Foodborne Illness about it.