Tag Archives: contamination

Food Safety Testing Market

Processed Meat and Poultry Applications Drive Food Safety Testing Industry

By Hrishikesh Kadam
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Food Safety Testing Market

The food safety testing industry is constantly experiencing new developments, technological advances and regulatory pressures as the burden of foodborne illness remains a prevalent concern. Growing consumer preference for convenience and processed foods is a pivotal trend augmenting the industry outlook.

The World Health Organization (WHO) reports that every year nearly $110 billion is lost across middle- and low-income countries due to unsafe food. From the health risk perspective, pathogens, pesticides or toxins cause more than 200 diseases, ranging from diarrhea to cancers. Since most foodborne illnesses are preventable, WHO and other public health organizations worldwide are taking necessary action to establish strong and resilient food safety systems and enhance consumer awareness.

Food products may become contaminated at any stage of production, supply or distribution. Testing food and beverage products for safety is a critical component of the food and beverages sector. In terms of annual valuation, the global food safety testing market size is anticipated to hit $29.5 billion by 2027.

Food Safety Testing Market
Food Safety Testing Market. Figure courtesy of Global Market Insights, Inc.

Pathogen Testing Demand Rises as E. coli, Salmonella Infections Persist

Pathogen testing is of utmost importance to the food & beverage industry, as there remains a large number of virus and bacteria causing pathogens and microbial agents responsible for foodborne illnesses. Numerous instances of pathogen contamination have come to light recently, augmenting the need for food pathogen testing, especially during a time when COVID-19 poses a significant threat.

For instance, in July, the CDC and the FDA announced that they are working with other public health agencies to investigate an outbreak of E. coli O121 infections across 11 states. Meanwhile in the European Union, several countries have started investigating Salmonella illnesses linked to imported tahini and halva. Since 2019, about 80 people are estimated to be affected in Germany, Denmark, Norway, Sweden and the Netherlands.

Pathogen testing demand will likely increase across North America and Europe with further spread of infections. These regions are among the major consumers of processed meat, seafood and poultry products, augmenting the need for reliable food safety testing solutions.

Meat, Poultry and Seafood Consumption Drive Foodborne Infection Risks

Globally more individuals are consuming processed poultry and meat products at home, in restaurants, fast food restaurants, and other locations. The worldwide meat consumption is estimated to reach 460 to 570 million tons by the year 2050, as per data from The World Counts.

It is essential to ensure optimum product quality during meat processing to minimize the perils of foodborne microorganisms. Meat quality testing standards are continuously evolving to ensure that food manufacturers bring the best-quality products to the market. In July this year Tyson Foods recalled more than 8.9 million pounds of ready-to-eat chicken products due to potential Listeria monocytogenes contamination. The significant recall quantity itself represents the scope of pathogen testing requirements in processed meat sector.

E. coli O157 is considered to increase the risk of toxins that lead to intestinal problems and can cause significant illness among geriatric people, pregnant women and other high-risk populations. Earlier this year, PerkinElmer introduced an E. coli O157 pathogen detection assay to be used for testing raw ground beef and beef trim. The solution is greatly suited for food and beverage sector customers that need to test high volumes of food samples regularly. The development indicates an incessant fight to offer effective food safety testing products to tackle the threat of pathogen-related illnesses.

USDA’s FSIS also recently revised guidelines for controlling Salmonella and Campylobacter infections in raw poultry. The updated guidelines provide poultry establishments with best practices that they may follow to reduce the risk of such infections in raw products.

Food Safety Testing Trends amid COVID-19 Pandemic

Food safety testing demand has experienced a notable uptick since the outbreak of the coronavirus pandemic, as food security and sustainability have been recognized as key areas of focus.

Globally, a rise in online orders of groceries and restaurant meals has been observed. Major food regulators such as the FDA have released food safety protocols and guidelines for food companies, hotels and restaurants. These practices help ensure optimum food quality as well as the safety of employees, staff and consumers.

The FDA has been working with the USDA and FSIS as well as state authorities to investigate foodborne illnesses and outbreaks amid the pandemic. Many regions are also updating food safety policies to help overcome the challenges of the pandemic. While pathogen and toxin testing demand are growing in most regions, the inadequacy of food control infrastructure may limit food safety testing industry expansion in emerging economies.

Drawbacks of existing technologies and the need to reduce sample utilization, lead time and testing cost are driving new innovations in food safety testing. Ongoing developments are focused on providing accurate results in limited timespan.
The food safety testing market landscape will continue to evolve as new regulations are introduced, public awareness rises, and food consumption patterns change. The rapid testing technology segment, which includes PCR, immunoassay and convenience testing, is estimated to hold a major share of the overall industry owing to faster results provided, which benefits the organizations in terms of productivity and processing costs. In addition to previously discussed PerkinElmer, Eurofins Central Analytical Laboratories Inc, Bio-Rad Laboratories, Intertek Group PLC, Bureau Veritas SA, and SGS AG are some of the other notable names in the industry.

Recall

McCormick & Company Initiates Voluntary Recall of Italian Seasoning Products and Frank’s RedHot Buffalo Ranch Seasoning

By Food Safety Tech Staff
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Recall

McCormick & Company, Inc. has initiated a voluntary recall of its McCormick Perfect Pinch Italian Seasoning, McCormick Culinary Italian Seasoning and Frank’s RedHot Buffalo Ranch Seasoning over concerns of Salmonella contamination. FDA uncovered the issue during routine testing.

The recalled products were shipped nationwide, as well as to Bermuda and Canada. between June 20 and July 21, 2021.

Thus far there have been no reports of illnesses related to this issue. McCormick has alerted customers and grocery retailers to remove and discard the product.

Attend the On-Demand Virtual Event:

Food Safety Hazards Series: Salmonella Detection, Mitigation, Control and Regulation

Food safety experts will discuss challenges and tangible best practices in Salmonella detection, mitigation and control, along with critical issues that the food industry faces with regards to the pathogen. This includes the journey and progress of petition to USDA on reforming and modernizing poultry inspections to reduce the incidence of Salmonella and Campylobacter; Salmonella detection, mitigation and control; and a case study on the pathogen involving crisis management.

Dollar

Developments in PCR Technology Boost Food Pathogen Testing Market Outlook

By Vinisha Joshi
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Dollar

In recent years, foodborne illness has ignited alarming concerns across the globe. Food products can become contaminated with pathogenic bacteria through exposure to inadequate processing controls, animal manure, improper storage or cooking, and cross contamination. The following is a look at some of the pivotal figures that illustrate the effects of food contamination:

  • • According to WHO, an estimated of 600 million people globally fall ill after consuming contaminated food, of which 420,000 succumb to death every year.
  • Children under 5 years of age carry 40% of the foodborne disease burden, with 125,000 fatalities recorded annually.
  • Regionally, CDC reports suggest that foodborne pathogens cause nearly 9.6 million illnesses, 57,500 hospital admissions, and 1,500 deaths yearly in the United States alone.
  • Considering the financial aspects, it is essential to note that about $110 billion is lost almost every year in productivity and medical expenses from unsafe food consumption in low-and middle-income economies.

With such daunting numbers taking over the globe, there stands an innate requirement of cost-effective, easy-to-use, and accurate testing methods that ensure the consumer is delivered nothing but the safest food.

It has been estimated that global food pathogen testing market size could potentially surge to $5.5 billion by 2024.

Why is pathogen testing necessary? Pathogen testing is generally carried out to decrease and remove foodborne illnesses. It is a technique implemented in the very nascent stage of food production to ensure proper sanitation and food safety. The testing can be done using conventional technologies or the cutting-edge methods, including Polymerase Chain Reaction (PCR) or an immunoassay test.

PCR technology: An ideal and convenient technology in use for pathogen detection in food industry

PCR is one of the most frequently used technologies. The test enables the detection of a single bacterial pathogen, including E. Coli, Salmonella and Listeria, present in food by detecting a specific target DNA sequence. Aiding to such advantages, various business conglomerates that are involved in the food pathogen testing industry are taking strategic measures to bring forth novel innovations and practices in the space. The following is a brief snapshot of some developments in the PCR based pathogen testing technology landscape:

  • Sanigen, Ilumina partnership for development of NGS panel
    Owing to the escalating demand for PCR testing technology for detecting the presence of food pathogens, South Korea-based Sanigen, recently announced standing as a channel partner in the region for Illumina. Both the companies, in unison, are expected to work towards the development of NGS panels that can robustly detect 16 types of foodborne pathogen from around 400 samples.
  • Thermo Scientific’s 2020 launch of SureTest PCR Assays
    Last year Thermo Scientific expanded its portfolio of foodborne pathogen detection with the launch of the SureTest PCR Assays. The testing technology is poised to offer various food producers an access to a more holistic range of tests for every step of the analysis process.

A look at one sector: How is the expanding dairy sector complementing the growth structure of food pathogen testing market?

The dairy production industry is rapidly expanding in various developing and developed economies, marking a significant contribution to health, environment, nutrition and livelihoods. According to a National Farmers Union report, the U.S. dairy industry accounts for 1% of the GDP, generating an economic impact of $628 billion, as of 2019. However, dairy products, although deemed healthy, can contribute to severe human diseases in umpteen ways, with dairy-borne diseases likely to top the list.

Milk and products extracted from the milk of dairy cows can house a variety of microorganisms, emerging as a source of foodborne pathogens. This has pushed the need for appropriate testing methods and technologies, which can eliminate the presence of dairy-borne bacteria, like Salmonella.

Today, various rapid pathogen testing solutions that are suitable for detecting the presence of distinct bacteria and organisms are available for dairy-based food companies. For instance, PCR-based solutions are available to test for mastitis in dairy, which is a common rudder infection caused by microorganisms in dairy cattle, affecting the quality of milk. Apparently, Thermo Fisher offers VetMAX MastiType qPCR kits for relatively faster, efficient and easier mastitis diagnostics. In fact, the kits are deemed to be reliable tools that would accurately detect all mastitis causing bacteria in frozen, fresh and preserved milk samples.

Meat Products

Consumption of raw or undercooked meat is also expected to generate a significant food pathogen testing kits demand in the coming years. Common contaminants found in these products are E. coli and Salmonella. One of the strains of E. coli, Shiga Toxin-producing E. coli (STEC), is expected to emerge as a fatal contaminant present in the meat products. Consider the following:

  • WHO reports estimate that up to 10% of patients with STEC infection are vulnerable to developing haemolytic uraemic syndrome (HUS), with a case-mortality rate ranging from 3 to 5%.
  • Moreover, it has the ability to cause neurological complication in 25% of HUS patients and chronic renal sequelae, in around 50% of survivors.

Under such circumstances, the demand for pathogen testing in meat products, for detecting E. coli and other contaminants is gradually expanding worldwide. In January this year, PerkinElmer introduced its new tool for detection of E. coli O157 in food products. The kit has been developed for generating rapid results while simultaneously putting them forth to support food safety efforts related to beef and its self-life.

The global food and beverage sector is subject to stringent safety requirements and a considerable part of the responsibility lies with food producers. As such, access to rapid testing technologies will enable the producers to fulfill their safety obligations without compromising on productivity and bottom lines. The consistent development of PCR-based tools will certainly outline the gradual progress of food pathogen testing industry, keeping in mind the high penetration of dairy and processed meat products worldwide.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

The Sun Does Not Shine on This Food Staple

By Susanne Kuehne
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Susanne Kuehne, Decernis
Rice fraud, Australia
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image credit: Susanne Kuehne

Organized crime in Eastern Europe has targeted a well-known top-level brand in Australia, shipping counterfeit rice to countries around the world under their brand. Rice grown and processed under uncontrolled conditions can bode a risk to human health due to unsanitary processing conditions and contamination from heavy metals. The affected company has initiated thorough investigations into this matter and indeed seized some counterfeit product in Saudi Arabia.

Resource

  1. Taylor, P. (July 7, 2021). “Criminal gang counterfeits Aussie rice brand SunRice”. Securing Industry.
Cybersecurity

As Cyber Threats Evolve, Can Food Companies Keep Up?

By Maria Fontanazza
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Cybersecurity

The recent cyberattack that shut down meat supplier JBS should be a wakeup call to the food industry. These attacks are on the rise across industries, and food operations both large and small need to be prepared. In a Q&A with Food Safety Tech, Brent Johnson, partner at Holland & Hart, breaks down key areas of vulnerability and how companies in the food industry can take proactive steps to protect their operations and ultimately, the consumer.

Food Safety Tech: Given the recent cyberattack on JBS, how vulnerable are U.S. food companies, in general, to this type of attack? How prepared are companies right now?

Brent Johnson, Holland & Hart
Brent Johnson, partner, Holland & Hart

Brent Johnson: Food companies are in the same boat as other manufacturers. Cyber threats are constantly evolving and hackers are developing increasingly sophisticated delivery systems for ransomware. Food companies are obviously focused on making and delivering safe and compliant products and getting paid for them. Cybersecurity is important, but it’s difficult for manufacturers to devote the resources necessary to make their systems bulletproof when it’s an ancillary part of their overall operations and a cost driver. Unfortunately, hackers only have one job.

We tend to think of big tech and financial services companies as the prime targets for ransomware attacks because of the critical nature of their technology and data, but food companies are really no different. Plus, unlike tech companies and the financial services industry, food companies haven’t, as a general matter, developed the robust defenses necessary to thwart attacks, so they’re easier targets.

Food Safety Tech: What is the overall impact of a cyberattack on a food company, from both a business as well as a consumer safety perspective?

Johnson: It may come as a bit of a surprise to those who don’t work in the food industry, but food production (from slaughterhouses to finished products) is highly automated and data driven. That’s one of the lessons of the JBS ransomware attack. The attack shut down meat processing facilities across the United States and elsewhere. I work in Utah and the JBS Beef Plant in Hyrum was temporarily shut down. JBS cancelled two shifts at its meatpacking operation in Greeley, Colorado where my firm has a large presence as well, because of the ransomware attack. So, the impact on a food company’s business from a successful ransomware attack is dramatic.

On the consumer safety side, a ransomware attack that impacts automated safety systems would cause significant problems for a food manufacturer. Software controls much of the food industry’s safety systems—from sanitation (equipment washdowns and predictive maintenance) to traceability (possible pathogen contamination and recalls) to ingredient monitoring (including allergen detection). Every part of a food company’s production system is traced, tracked, and verified electronically. A ransomware attack on a food maker would very likely compromise the company’s ability to produce safe products.

Food Safety Tech: What proactive steps should food companies be taking to protect themselves against a cyberattack?

Johnson: I wish there was an easy and foolproof system for food companies to implement to protect against cyber attacks, but there isn’t. The threats are always changing. The Biden Administration’s recent memorandum to corporate executives and business leaders on strengthening cyber defenses is a good starting point, however. The White House’s Deputy National Security Adviser for Cyber and Emerging Tech, Anne Neuberger, reiterated the following “Five Best Practices” from President Biden’s executive order. These practices are multifactor authentication, endpoint detection and response, aggressive monitoring for malicious activities on the company’s networks and blocking them, data encryption, and the creation of a skilled cyber security team with the ability to train employees, detect threats and patch system vulnerabilities.

Food Safety Tech: Are there specific companies within the food industry that are especially susceptible?

Johnson: Not really. Hackers are opportunistic and look for the paths of least resistance. That said, as can be seen from the recent Colonial Pipeline and JBS ransomware attacks, hackers have transitioned from the early days of going after individuals and small businesses to whale hunting. The money is better.

It’s important to observe that the recent attacks have been directed at industries that present national infrastructure concerns (oil, the food supply). There’s no evidence of any involvement by a foreign government in these attacks, but it’s a fair question as to whether the hackers, themselves, expect that the federal government will step in at some point to assist the victims of cyber attacks financially due to their critical importance.

Food Safety Tech: Where do you see the issue of cybersecurity and cyberattacks related to the food industry headed in the future?

Johnson: Other than the certainty that the attacks will increase in both intensity and sophistication, I have no prediction. It’s not a time for complacency.

Emily Newton, Revolutionized Magazine
FST Soapbox

How Food Processors Can Use Robots to Improve Food Quality

By Emily Newton
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Emily Newton, Revolutionized Magazine

Across industries, new innovations in robotics technologies are helping to speed up day-to-day work and improve product quality. Robots can be especially effective for businesses in the food processing industry, where a growing labor shortage poses trouble for processors.

While a number of critical industry tasks were difficult to fully or partially automate in the past, new robotics technology is helping to increase the number of potential applications for robots in the industry.

Consistency, Accuracy, and Speed

Food processing robots offer a few major advantages over conventional food processing workflows. Robots can perform a task repeatedly over the course of a work day or shift, typically with minimal deviation in precision. Unlike human workers, robots don’t get tired, and their pace of work tends to stay consistent. This combination of accuracy and speed has been found to increase site throughput while ensuring packaged products are up to company standards.

Food processors that adopt robots also see major gains in item consistency—more often, packaged products contain the same amount of food, weigh the same, and are packaged in the same manner.

Automated packaging systems can sometimes be a poor fit for certain food commodities, especially for products like delicate fruits and vegetables.

Experimentation, however, often leads to custom solutions that can handle these unique challenges. After experimentation with new weighing and packaging robots in the cannabis industry, for example, processors were able to accelerate the packaging process and create more consistently packaged items.

In the food processing industry, this can come in the form of robots with soft silicon grippers and attachments, which help companies package delicate products.

Workers production line
Workers in a factory sorting food by hand, could be assisted by new robot technology. (Unsplash image)

Preventing Cross Contamination

Despite improved food safety standards, foodborne disease outbreaks remain common in the United States.

The use of robots can help control cross-contamination in food processing plants.

With any human labor force comes the risk of cross-contamination. Workers assigned to packaging foods can easily transport pathogens from product to product or from one area of the facility to another. This is especially true in sites that process raw meat products. Even when following proper site hygiene practices, it’s possible for workers to unintentionally transport pathogens and other contaminants from one workcell to another.

Because work in food processing facilities is often shoulder-to-shoulder, it’s also easy for contaminants to spread from one worker to another once a particular cell has been contaminated.

Robots that are fixed in place and handle all the aspects of a particular packaging job can help localize potential contamination, making it easier for processors to minimize cross-contamination and keep food safe.

Robots can still contribute to cross contamination if not properly cleaned, but an additional set of robots could solve this problem, too. For example, one a provider of robots for the food processing industry has developed a set of robots capable of washing down an entire workcell.

These robots, working in pairs, activate at the end of each operating cycle and use high-powered jets of water to wash down the workcell, the packaging robots used there, and themselves.

Collaborative Robotics (Cobots)

One major recent innovation in robots has a new focus on tech that is collaborative.

These new robots, unlike conventional robotics, aren’t always built to fully automate a particular task. Instead, they are built to interact and work collaboratively alongside humans where necessary.

Artificial intelligence-based machine vision technology helps them navigate factory floors safely or assist in tasks like assembly and machine tending. Safety features like force limiters and padded joints help prevent injuries that can occur while working in close proximity to conventional robots.

These features also enable them to work in tight spaces without the use of safety cages that conventional robots sometimes require. In factories and food processing plants, they can provide assistance and speed up existing workflows.

For example, an article in Asia Pacific Food Industry cites one case study from a Swedish food processor, Orkla Foods. The company integrated cobots into a production line packaging vanilla cream, freeing up the human workers who had been responsible for the task. Before the cobots were introduced, workers had to bag and manually pack the vanilla cream into cartons.

Even with cobots, human workers are still necessary for tasks that require judgment, creativity, and problem-solving skills. Cobots can take over tasks that don’t lend themselves well to automation. These tasks tend to be tedious, dull, or even dangerous due to the repetitive motions workers need to make.

Even if a task can’t be fully automated, cobots can still help improve efficiency and boost accuracy. These robots provide the most significant benefits for businesses that need flexibility and agility in production.

Cobots are often lightweight and easy to reprogram on-the-fly, allowing workers to quickly move them from task to task as needed. In many cases, an entire fleet of cobots can be repositioned and reprogrammed in half a day, allowing a business to reconfigure its robots to handle entirely new tasks without additional capital investment.

This flexibility can also make cobots a better fit for personalized products than other systems. As product specifications change, a cobot can be easily programmed and reprogrammed to handle the differences.

The use of these robots can also help prevent cross contamination, like more conventional robotics.

Sector-Specific Applications

A handful of sectors within the food processing industry can also benefit from niche robotics designed to automate certain specific tasks.

Danish robotics manufacturer Varo, for example, developed a line of cake decorating and filling robots. These robots are designed with technology that allows them to determine which cake will be decorated next, minimizing the amount of human involvement needed to operate.

While these robots won’t be useful for every manufacturer, they are a good example of how many sectors within the industry stand to benefit from robots that can automate niche tasks.
Using Food Processing Robots to Improve Product Quality and Consistency
Robots help automate tasks that are dull, dirty or dangerous. In doing so, they typically provide businesses with significant upgrades to process accuracy, speed, and consistency.

New technology—like machine vision and collaborative robotics technology—is helping to expand the use cases of robots in the food processing industry. These robots can often improve product quality more effectively than process changes alone, and may help manage a labor gap that could persist well into the future.

The More The Merrier: A Multi-Hurdle Approach to Detection

Prevention of foreign object contamination is a growing priority for food processors. Multi-hurdle approaches are becoming a more common method to foreign materials detection in processing plants. During this webinar, we’ll look at what a multi-hurdle approach can look like in different environments, along with the emerging set of technologies for automated inspection: Vision systems.

FDA

FDA to Begin Testing Samples of Salinas-Grown Lettuce for E. Coli and Salmonella

By Food Safety Tech Staff
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FDA

Register now for the complimentary virtual event in our Food Safety Hazards Series, “Salmonella Detection, Mitigation, Control and Regulation” | Thursday, July 15, 11:45 am ETAs part of ongoing surveillance efforts resulting from recurring outbreaks, the FDA announced that it will conduct direct sampling and testing of lettuce grown in the Salinas Valley region of California. From May through November 2021, the agency will test samples for Shiga toxin-producing Escherichia coli (STEC), including E. coli O157:H7, and Salmonella spp. Direct sampling will be conducted at commercial cooling and cold storage facilities where field heat is removed from harvested lettuce and product is cold-stored prior to processing. “Sample collection at commercial coolers helps the FDA efficiently obtain samples from multiple farms at centralized locations and facilitates prompt traceback and follow-up if contamination is detected,” according to a CFSAN update.

FDA laboratories plan to test about 500 post-harvest samples of iceberg, leaf and romaine lettuce, with each sample consisting of 10 subsamples (one head of lettuce that is trimmed, cored or wrapped; or romaine lettuce leaves or one package of hearts).

In compliance with COVID-19 safety practices, the agency investigators will preannounce their visits.

magnifying glass

Surveying the Phthalate Litigation Risk to Food Companies

By Kara McCall, Stephanie Stern
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magnifying glass

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.