The first half of 2021 saw almost a 20% increase in recalls vs. the last 6 months of 2020 (117 vs. 96). According to a recent report by Lathrop GPM, LLC, food producers have seen an increase in food safety incidents since the pandemic began, and expect an ongoing increase over the next year.1 A majority of recalls were due to undeclared allergens or potential for allergen cross contamination. Second to allergens were potential for microbiological contaminants, including Salmonella, Listeria, E. coli, and Cyclospora.
Figure 1 and 2. The first half of 2021 saw a 26% increase of facility inspections by the FDA. Despite this jump, inspections in the first half of 2020 were 80% higher than this year’s first six months. Source: FDA Recalls, Market Withdrawals, & Safety Alerts.
Inspection Results
The first half of 2021 saw a 26% increase of facility inspections by the FDA. Despite this jump, inspections in the first half of 2020 were 80% higher than this year’s first six months. Inspections generally lead to three outcomes; No Action Indicated (continue as you were,) Voluntary Action Indicated (voluntary to make some changes), or Official Action Indicated (OAI) (Regulatory Actions will be recommended by the FDA). A majority of inspections (56%) resulted in NAI this year, compared to 59% and 50% in the first and second halves of 2020, respectively.
The FSIS provides ongoing surveillance of Salmonella and Campylobacter presence in poultry, both domestic and imported. Salmonella is reported by facility and each is given a category rating of 1–3. One is exceeding the standard (based on a 52-week moving average), two is meeting the standard, and three is below standard. For the 52-week reporting period ending May 30, 2021, 60% achieved category one, compared to 56% the previous 52 weeks.
Figures 4 & 5. Salmonella surveillance data from FDA.
Listeria and Salmonella Surveillance in RTE Meat and Poultry
USDA FSIS conducts periodic sampling of Ready to Eat (RTE) meat and poultry products and reports quarterly results. Sampling is conducted both in a random fashion as well as based on risk-based sampling. In Q2 2021, 4769 samples were tested for Listeria, compared to 4632 in Q1.
Percent positive rates were .36% for Q2 and .43% for Q1. Neither quarter reported any positives for Listeria in imported RTE Meat and Poultry Products.
Salmonella samples for RTE totaled 3676 in Q2 2021, compared with 3566 in Q1. In both quarters, only 1 positive was found in the samples collected.
Routine Beef Sampling for E. coli 0157:H7 and STEC
The FSIS also conducts ongoing routine sampling of beef products for E. coli. E. coli is further classified into 0157:H7 and non-0157:H7 Shiga toxin-producing E. coli (STEC). In Q2 of 2021, 4467 samples were collected and tested for 0157:H7 versus 4268 in Q1. Of these, three were positive, compared to seven positives the preceding quarter. For STEC, a total of 8 positives were found, compared to 1 positive in Q1. No positives were found in imported goods in Q2, although in Q1 2021, 4 positives for STEC were found.
Conclusion
The first half of 2021 showed an increase in activity, which is on par with food industry survey data. Food recalls have increased, with food allergens remaining the most prevalent reason for recall or withdrawal. While inspections also increased, they have not returned to pre-pandemic levels. The impact of the spread of the Delta variant and increased restrictions is yet to be seen, but inspection activity will likely not rebound entirely by the end of the year. Pathogen tests by FSIS increased quarter over quarter for Salmonella, E. coli, and STEC, with mixed results in prevalence.
The food allergen testing industry has garnered considerable traction across North America, especially due to the high volume of processed food and beverages consumed daily. Allergens are becoming a significant cause for concern in the present food processing industry worldwide. Food allergies, which refer to abnormal reactions or hypersensitivity produced by the body’s immune system, are considered a major food safety challenge in recent years and are placing an immense burden on both personal and public health.
In 2019, the most common reason behind recalls issued by the USDA FSIS and the FDA was undeclared allergens. In light of this growing pressure, food producers are taking various steps to ensure complete transparency regarding the presence of allergenic ingredients, as well as to mitigate risk from, or possibly even prevent contact with, unintended allergens. One of these steps is food allergen testing.
Allergen detection tests are a key aspect of allergen management systems in food processing plants and are executed at nearly every step of the process. These tests can be carried out on work surfaces, as well as the products, to detect any cross contamination or allergen presence, and to test the effectiveness of a food processing unit’s cleaning measures.
There has been a surge in awareness among consumers about food allergies and tackling the risk of illnesses that may arise from consuming any ingredient. One of the key reasons for a higher awareness is efforts to educate the public. In Canada, for example, May has been designated “Food Allergy Awareness Month”. It is estimated that more than 3 million people in Canada are affected by food allergies.
The size of the global food allergen testing market is anticipated to gain significant momentum over the coming years, with consistent expansion of the dairy, processed food and confectionary segments.
Understanding the Prevailing Trends in Food Allergen Testing Industry
Food allergies risen nearly 50% in the last 10 years, with a staggering 700% increase observed in hospitalizations due to anaphylaxis. Studies also suggest that food allergies are a growing health concern, with more than 250 million people worldwide estimated to be affected.
Although more than 170 foods have been identified as causing food allergies in sensitive consumers, the USDA and the FDA have identified eight major allergenic foods, based on the 2004 FALCPA (the Food Allergen Labeling and Consumer Protection Act). These include eggs, milk, shellfish, fish, peanuts, tree nuts, soybean, and wheat, which are responsible for 90% of allergic reactions caused due to food consumption. In April 2021, the FASTER (Food Allergy Safety, Treatment, Education, and Research) Act was signed into law, which categorized sesame as the ninth major food allergen.
This ever-increasing prevalence of allergy-inducing foods has presented lucrative opportunities for the food allergen testing industry in recent years since food processing business operators are placing a strong emphasis on ensuring transparency in their products’ ingredient lists. By testing for allergens in food products, organizations can accurately mention each ingredient, and thereby allow people with specific food allergies to avoid consuming them.
Several allergen detection methods are used in the food processing industry, including mass spectrometry, DNA-based polymerase chain reaction (PCR) as well as ELISA (enzyme-linked immunosorbent assay), to name a few. The FDA, for instance, created a food allergen detection assay, called xMAP, designed to simultaneously identify 16 allergens, including sesame, within a single analysis, along with the ability to expand for the targeting of additional food allergens. Such industry advancements are improving the monitoring process for undeclared allergen presence in the food supply chain and enabling timely intervention upon detection.
Furthermore, initiatives, such as the Voluntary Incidental Trace Allergen Labelling (VITAL), created and managed by the Allergen Bureau, are also shedding light on the importance of allergen testing in food production. The VITAL program is designed to support allergen management with the help of a scientific process for risk assessment, in order to comply with food safety systems like the HACCP (Hazard Analysis and Critical Control Point), with allergen analysis playing a key role in its application.
ELISA Gains Prominence as Ideal Tool for Food Allergen Testing
In life sciences, the detection and quantification of various antibodies or antigens in a cost-effective and timely manner is of utmost importance. Detection of select protein expression on a cell surface, identification of immune responses in individuals, or execution of quality control testing—all these assessments require a dedicated tool.
ELISA is one such tool proving to be instrumental for both diagnostics as well as research). Described as an immunological assay, ELISA is used commonly for the measurement of antibodies or antigens in biological samples, including glycoproteins or proteins.
While its utility continues to grow, ELISA-based testing has historically demonstrated excellent sensitivity in food allergen testing applications, in some cases down to ppm (parts per million). It has a distinct advantage over other allergen detection methods like PCR, owing to the ability to adapt to certain foods like milk and oils, where its counterparts tend to struggle. The FDA is one of the major promoters of ELISA for allergen testing in food production, involving the testing of food samples using two different ELISA kits, prior to confirming results.
Many major entities are also taking heed of the growing interest in the use of ELISA for food allergen diagnostics. A notable example of this is laboratory analyses test kits and systems supplier, Eurofins, which introduced its SENSISpec Soy Total protein ELISA kit in September 2020. The enzyme immunoassay, designed for quantitative identification of soy protein in swab and food samples, has been developed by Eurofins Immunolab to measure residues of processed protein in various food products, including instant meals, chocolate, baby food, ice cream, cereals, sausage, and cookies, among others.
In essence, food allergens continue to prevail as high-risk factors for the food production industry. Unlike other pathogens like bacteria, allergenic proteins are heat resistant and stable, and cannot easily be removed once present in the food supply chain. In this situation, diagnostic allergen testing, complete segregation of allergenic substances, and accurate food allergen labeling are emerging as the ideal courses of action for allergen management in the modern food production ecosystem, with advanced technologies like molecular-based food allergy diagnostics expected to take up a prominent role over the years ahead.
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.
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 controllingSalmonella 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.
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.
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.
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.
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
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).
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.
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).
FDA Guidance for Industry. Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP) at 362, supra n.5.
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).
The COVID-19 pandemic heightened the urgency for food brands to adopt technology solutions that support remote management of environmental monitoring programs (EMPs) as they strive to provide safe products to customers. While digital transformation has progressed within the food safety industry, food and beverage manufacturers often have lower profitability as compared to other manufacturing industries, such as pharmaceutical and high-tech equipment, which can lead to smaller IT spend.1 Many companies still rely on manual processes for environmental monitoring and reporting, which are prone to error, fail to provide organizations with visibility into all of their facilities and limit the ability to quickly take corrective actions.
Despite growing recognition of the value of automating testing, diagnostics, corrective actions and analytic workflows to prevent contamination issues in food production environments, barriers to adoption persist. One key obstacle is the recurring mindset that food safety is a necessary compliance cost. Instead, we need to recognize that EMP workflow automation can create real business value. While the downside of food safety issues is easy to quantify, organizations still struggle to understand the upside, such as positive contributions to productivity and a stronger bottom-line achieved by automating certain food safety processes.
To understand how organizations are using workflow automation and analytics to drive quantifiable business ROI, a two-year study that included interviews and anonymized data collection with food safety, operations, and executive leadership at 34 food organizations was conducted.
The respondents represent more than 120 facilities using advanced EMP workflow automation and analytics. Based on the interviews and the shared experience of food organization leaders, two key examples emerged that demonstrate the ROI of EMP automation.
Improved Production Performance
According to those interviewed, one of the primary benefits of EMP automation (and driver of ROI) is minimizing production disruptions. A temporary conveyor shutdown, unplanned cleaning, or extensive investigatory testing can add up to an astounding 500 hours annually at a multi-facility organization, and cost on average $20,000 to $30,000 per hour.2 So, it’s obvious that eliminating costly disruptions and downtime has a direct impact on ROI from this perspective.
But organizations with systems where information collected through the EMP is highly accessible have another advantage. They are able to take corrective actions to reduce production impacts very quickly. In some cases, even before a disruption happens.
By automatically feeding EMP data into an analytics program, organizations can rapidly detect the root cause of issues and implement corrective actions BEFORE issues cause production delays or shutdowns.
In one example, over the course of several months, a large dairy company with manual EMP processes automated its food safety workflows, improved efficiencies, reduced pathogen positives and improved its bottom line. At the start of the study, the company increased systematic pathogen testing schedules to identify where issues existed and understand the effectiveness of current sanitation efforts. With improved access to data on testing, test types and correlated sanitation procedures, the company was able to implement a revamped remediation program with more effective corrective action steps.
Ultimately, the automated workflows and analytics led to reduced positive results and more efficient EMP operations for the company as compared to the “crisis-mode” approach of the past. The associated costs of waste, rework, delayed production starts, and downtime caused by food safety issues were significantly reduced as illustrated in Figure 1.
Figure 1: Reduction of food safety testing costs through EMP automation. Customer Study 2016-2018. All figures courtesy of Corvium, Inc.
Quantifying the ROI of Production Performance Improvements
The financial impact of reducing production downtime by just 90 minutes per week can be dramatic when looked at by cumulative results over multiple weeks. In fact, eliminating just a few delayed starts or unplanned re-cleaning can have significant financial gains.
Figure 2 shows the business impact of gaining 90 minutes of production up-time per week by automating food safety operations. For the purposes of this analysis, the “sample organization” depicted operates two facilities where there are assumptions that down-time equates to a cost value of $30,000 per hour, and that both plants experience an average of 90 minutes of downtime per week that can be re-gained.
Figure 2: Sample Production Performance Improvement ROI Calculation.
Reduced Food Waste
The second key insight uncovered in the two-year study was the impact that automating the EMP process had on waste. An estimated 30–40% of all food produced in the United States is wasted, and preventable food safety and quality issues account for a substantial portion of this waste.3
A key challenge shared by study participants was detecting food safety issues early enough to avoid wasting an entire production run. Clearly, the later in a processing or manufacturing run that issues are discovered, the greater the potential waste. To limit this, organizations needed near real-time visibility into relevant food safety and EMP data.
By automating EMP workflows, they solved this issue and created value. By tracking and analyzing data in near real time, production teams were able to keep up with ever-moving production schedules. They could define rules to trigger the system to automatically analyze diagnostic results data and alert stakeholders to outliers. Impacted food product could be quickly identified and quarantined when needed before an entire production run was wasted.
Companies included in the study realized substantial benefits from the increased efficiencies in their testing program. According to a food safety quality assurance manager at a large U.S. protein manufacturer, “Our environmental monitoring program has reached new heights in terms of accuracy, communication, visibility and efficiency. Manual, time-intensive tasks have been automated and optimized, such as the ability to search individual sample or submittal IDs, locate them quickly and make any necessary changes.”
Quantifying the ROI of Food Waste Reductions
Figure 3 shows how measuring the business impact of gaining back just 10% of scrapped food per week. For the purposes of this analysis, the “sample organization” depicted operates two facilities where there are 500 lbs. of finished product scrapped each week, and the value per pound of finished product is valued at a cost of $1 per pound.
Figure 3. Sample Waste Reduction ROI Calculation.
Conclusion
Automating EMP workflows decreases the time required to receive and analyze critical EMP data, helping food manufacturers achieve significant improvements in production performance, waste reduction and overall testing efficiency. By using these same ROI calculations, food brands can better illustrate how improved food safety processes can build value, and help leaders see food safety as a brand imperative rather than a cost center. As food organizations progress through each stage of digital transformation, studies like this can show real-world examples of business challenges and how other organizations uncovered value in adoption of new technologies and tools.
Vitamins play a critical role in the regulation of key physiological processes, such as blood clotting, metabolism and maintaining our vision. These biologically important compounds can be divided into two broad classes based on their solubility and differ in the way they are handled in the body—and in food safety laboratories. While excess amounts of water-soluble vitamins (including B1, B2, B3, B6 and B12) are excreted, fat-soluble vitamins (including vitamin A, D, E and K) can be stored in the liver or fatty tissue for later use. The simultaneous analysis of water- and fat-soluble vitamins in traditional liquid chromatography is difficult, and is compounded by the presence of biologically important vitamin isomers, which exist at lower concentrations and demand greater sensitivity from analytical techniques.
Food analysis laboratories support food manufacturers by assessing food safety and authenticity, and have a responsibility to produce precise and reliable data. Vitamins are among a number of compounds assessed in infant formulas, energy drinks and other supplements, and are added to fortify the nutritional value of these products. Given the critical nutritional role of vitamins, especially during early developmental periods, their characterization is highly important. This, along with the challenging and cumbersome nature of vitamin analysis, has spurred the development of innovative high-performance liquid chromatography (HPLC) methods for food safety testing.
Unique Challenges of Vitamin Analysis
The simultaneous analysis of water- and fat-soluble vitamins is difficult to achieve with reversed-phase high-performance liquid chromatography, due to the wide range of hydrophobicity among vitamins. Highly hydrophobic fat-soluble vitamins are retained strongly by chromatography columns and are only eluted with high-strength mobile phases. In contrast, water-soluble vitamins are usually poorly retained, even with very weak mobile phases. As the ideal conditions for chromatographic separation are very different for the two vitamin classes, there have been efforts to explore the possibility of operating two columns sequentially in one system. The early versions of this approach, however, were not well suited to high-throughput food safety laboratories, requiring complex hardware setup and even more complicated chromatography data system programming.
Prior to liquid chromatography analysis, food samples must be purified and concentrated to ensure target analytes can be detected without matrix interference. Liquid-liquid extraction is one purification method used to prepare for the analysis of vitamins and other compounds; it was one of the first methods developed for purification and enables compounds to be separated based on their relative solubilities in two different immiscible liquids.1 It is a simple, flexible and affordable method, yet has several major disadvantages.2 Liquid-liquid extraction consists of multiple tedious steps and requires the use of large volumes, therefore the time for completion is highly dependent on the operator’s skills and experience. Consequently, the duration of sample exposure to unfavorable conditions can vary greatly, which compromises reproducibility and efficiency of the method. This is of concern for vitamins that are particularly prone to degradation and loss when exposed to heat and light, such as vitamin D in milk powder.
Two-Dimensional Liquid Chromatography Enables Deeper and Faster Analysis
Analysts in the food industry are under pressure to process high volumes of samples, and require simple, high-throughput and high-resolution systems. Fortunately, two-dimensional liquid chromatography (2D-LC) systems have evolved markedly in recent years, and are ideally suited for the separation of vitamins and other compounds in food and beverages. There are two main types of systems, known as comprehensive and heart-cutting 2D-LC. In comprehensive 2D-LC, the sample is separated on the first column, as it would be in 1D-LC. The entire eluate is then passed in distinct portions into a second column with a different selectivity, enabling improved separation of closely eluting compounds. In contrast, heart-cutting 2D-LC is more suited to targeted studies as only a selected fraction (heart-cut) of the eluate is transferred to the second-dimension column.
Recently, another novel approach has emerged which utilizes two independent LC flow paths. In dual workflows, each sample is processed by two columns in parallel, which are integrated in a single instrument for ease of use. The columns may offer identical or different analyses to enable a higher throughput or deeper insights on each sample. This approach is highly suited to vitamin analysis, as the two reversed-phase columns enable simultaneous analysis of water- and fat-soluble vitamins. A simple, optimized preparation method is required for each of the two vitamin classes to ensure samples are appropriately filtered and concentrated or diluted, depending on the expected amount of analyte in the sample. The dual approach enables a broad range of ingredients to be assessed concurrently in supplement tablets, energy drinks, and other food and beverages containing both water- and fat-soluble vitamins. For analysts working to validate claims by food vendors, these advances are a welcome change.
Refined Detection and Extraction Methods Create a Boost in Productivity
Analysts in food analysis laboratories now have a better ability to detect a wide range of components in less time, due to improved detection and extraction methods. Modern LC systems utilize a wide range of analytical detectors, including:
Mass spectrometry (MS)
Diode array detection (DAD)
Multi-wavelength detection
Charged aerosol detection (CAD)
Fluorescence detection (FLD)
The optimal detector technology will depend on the molecular characteristics of the target analyte. Infant formula, for example, can be analyzed by DAD and FLD, with detection and separation powerful enough to accurately quantify the four isomers of vitamin E, and separate vitamin D2 and D3. Highly sensitive 2D-LC methods are also particularly favorable for the trace level quantitation of toxins in food, such as aflatoxins in nuts, grains and spices.
Given the limitations of liquid-liquid extraction, an alternative, simplified approach has been sought for 2D-LC analysis. Liquid-liquid extraction, prior to chromatography analysis, involves many tedious separation steps. In contrast, the use of solid phase extraction for infant formula testing reduces pre-treatment time from three hours to one hour, while improving detection. This is of great significance in the context of enterprise product quality control, where a faster, simpler pre-treatment method translates into a greater capacity of product testing and evaluation.
HPLC Toolkit for Food Safety Analysis Continues to Expand
Several other HPLC approaches have also been utilized in the field of food safety and authentication. For example, ultra-high-performance liquid chromatography (UHPLC) with detection by CAD followed by principal component analysis (PCA) can be used to investigate olive oil purity. In contrast to conventional approaches (fatty acid and sterol analysis), this revised method requires very little time and laboratory resources to complete, enabling companies to significantly reduce costs by implementing in-house purity analysis. With a reduced need for chemicals and solvents compared with fatty acid and sterol analyses, UHPLC-CAD provides a more environmentally friendly alternative.
Analyzing amino acid content in wine is an important aspect of quality control yet requiring derivatization to improve retention and separation of highly hydrophilic amino acids. Derivatization, however, is labor-intensive, error-prone, and involves the handling of toxic chemicals. To overcome these limitations, hydrophilic interaction liquid chromatography (HILIC) combined with mass detection has been identified as an alternative method. While HILIC is an effective technique for the separation of small polar compounds on polar stationary phases, there still may be cases where analytes in complex samples will not be completely separated. The combination of HILIC with MS detection overcomes this challenge, as MS provides another level of selectivity. Modern single quadrupole mass detectors are easy to operate and control, so even users without in-depth MS expertise can enjoy improved accuracy and reproducibility, while skipping derivatization steps.
Conclusion
Recent innovations in 2D- and dual LC technology are well suited to routine vitamin analysis, and the assessment of other components important in food safety evaluation. The concurrent and precise assessment of water- and fat-soluble vitamins, despite their markedly different retention and elution characteristics, is a major step forward for the industry. Drastic improvements in 2D-LC usability, flexibility and sensitivity also allows for biologically important vitamin isomers to be detected at trace levels. A shift towards simpler, high-throughput systems that eliminate complicated assembly processes, derivatization and liquid-liquid extraction saves time and money, while enabling laboratories to produce more reliable results for food manufacturers. In terms of time and solvent savings, solid phase extraction is superior to liquid-liquid extraction and is one of many welcome additions to the food analysis toolkit.
References
Schmidt, A. and Strube, J. (2018). Application and Fundamentals of Liquid-Liquid Extraction Processes: Purification of Biologicals, Botanicals, and Strategic Metals. In John Wiley & Sons, Inc (Ed.), Kirk-Othmer Encyclopedia of Chemical Technology. (pp. 1–52).
Musteata, M. and Musteata, F. (2011). Overview of extraction methods for analysis of vitamin D and its metabolites in biological samples. Bioanalysis, 3(17), 1987–2002.
Recent food scandals around the world have generated strong public concerns about the safety of the foods being consumed. Severe threats to food safety exist at all stages of the supply chain in the form of physical, chemical and biological contaminants. The current pandemic has escalated the public’s concern about cross contamination between people and food products and packaging. To eliminate food risks, manufacturers need robust technologies that allow for reliable monitoring of key contaminants, while also facilitating compliance with the ISO 17025 standard to prove the technical competence of food testing laboratories.
Without effective data and process management, manufacturers risk erroneous information, compromised product quality and regulatory noncompliance. In this article, we discuss how implementing a LIMS platform enables food manufacturers to meet regulatory requirements and ensure consumer confidence in their products.
Safeguarding Food Quality to Meet Industry Standards
Food testing laboratories are continually updated about foodborne illnesses making headlines. In addition to bacterial contamination in perishable foods and ingredient adulteration for economic gains, chemical contamination is also on the rise due to increased pesticide use. Whether it is Salmonella-contaminated peanut butter or undeclared horsemeat inside beef, each food-related scandal is a strong reminder of the importance of safeguarding food quality.
Food safety requires both preventive activities as well as food quality testing against set quality standards. Establishing standardized systems that address both food safety and quality makes it easier for manufacturers to comply with regulatory requirements, ultimately ensuring the food is safe for public consumption.
In response to food safety concerns, governing bodies have strengthened regulations. Food manufacturers are now required to ensure bacteria, drug residues and contaminant levels fall within published acceptable limits. In 2017, the ISO 17025 standard was updated to provide a risk-based approach, with an increased focus on information technology, such as the use of software systems and maintaining electronic records.
The FDA issued a notice that by February 2022, food testing, in certain circumstances, must be conducted in compliance with the ISO 17025 standard. This means that laboratories performing food safety testing will need to implement processes and systems to achieve and maintain compliance with the standard, confirming the competence, impartiality and consistent operation of the laboratory.
To meet the ISO 17025 standard, food testing laboratories will need a powerful LIMS platform that integrates into existing workflows and is built to drive and demonstrate compliance.
From Hazard Analysis to Record-Keeping: A Data-Led Approach
Incorporating LIMS into the entire workflow at a food manufacturing facility enables the standardization of processes across its laboratories. Laboratories can seamlessly integrate analytical and quality control workflows. Modern LIMS platforms provide out-of-the-box compliance options to set up food safety and quality control requirements as a preconfigured workflow.
The requirements set by the ISO 17025 standard build upon the critical points for food safety outlined in the Hazard Analysis and Critical Control Points (HACCP) methodology. HACCP, a risk-based safety management procedure, requires food manufacturers to identify, evaluate and address all risks associated with food safety.
LIMS can be used to visualize control points for HACCP analysis according to set limits. Graphic courtesy of Thermo Fisher Scientific.
The systematic HACCP approach involves seven core principles to control food safety hazards. Each of the following seven principles can be directly addressed using LIMS:
Principle 1. Conduct a hazard analysis: Using current and previous data, food safety risks are thoroughly assessed.
Principle 2. Determine the critical control points (CCPs): Each CCP can be entered into LIMS with contamination grades assigned.
Principle 3. Establish critical limits: Based on each CCP specification, analytical critical limits can be set in LIMS.
Principle 4. Establish monitoring procedures: By defining sampling schedules in LIMS and setting other parameters, such as frequency and data visualization, procedures can be closely monitored.
Principle 5. Establish corrective actions: LIMS identifies and reports incidents to drive corrective action. It also enables traceability of contamination and maintains audit trails to review the process.
Principle 6. Establish verification procedures: LIMS verifies procedures and preventive measures at the defined CCPs.
Principle 7. Establish record-keeping and documentation procedures: All data, processes, instrument reports and user details remain secured in LIMS. This information can never be lost or misplaced.
As food manufacturers enforce the safety standards set by HACCP, the process can generate thousands of data points per day. The collected data is only as useful as the system that manages it. Having LIMS manage the laboratory data automates the flow of quality data and simplifies product release.
How LIMS Enable Clear Compliance and Optimal Control
Modern LIMS platforms are built to comply with ISO 17025. Preconfigured processes include instrument and equipment calibration and maintenance management, traceability, record-keeping, validation and reporting, and enable laboratories to achieve compliance, standardize workflows and streamline data management.
The workflow-based functionality in LIMS allows researchers to map laboratory processes, automate decisions and actions based on set criteria, and reduce user intervention. LIMS validate protocols and maintain traceable data records with a clear audit history to remain compliant. Data workflows in LIMS preserve data integrity and provide records, according to the ALCOA+ principles. This framework ensures the data is Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) as well as complete, consistent and enduring. While the FDA created ALCOA+ for pharmaceutical drug manufacturers, these same principles can be applied to food manufacturers.
Environmental monitoring and quality control (QC) samples can be managed using LIMS and associated with the final product. To plan environmental monitoring, CCPs can be set up in the LIMS for specific locations, such as plants, rooms and laboratories, and the related samples can then be added to the test schedule. Each sample entering the LIMS is associated with the CCP test limits defined in the specification.
Near real-time data visualization and reporting tools can simplify hazard analysis. Managers can display information in different formats to monitor critical points in a process, flag unexpected or out-of-trend numbers, and immediately take corrective action to mitigate the error, meeting the requirements of Principles 4 and 5 of HACCP. LIMS dashboards can be optimized by product and facility to provide visibility into the complete process.
Rules that control sampling procedures are preconfigured in the LIMS along with specific testing rules based on the supplier. If a process is trending out of control, the system will notify laboratory personnel before the product fails specification. If required, incidents can be raised in the LIMS software to track the investigation of the issue while key performance indicators are used to track the overall laboratory performance.
Tasks that were once performed manually, such as maintaining staff training records or equipment calibration schedules, can now be managed directly in LIMS. Using LIMS, analysts can manage instrument maintenance down to its individual component parts. System alerts also ensure timely recalibration and regular servicing to maintain compliance without system downtime or unplanned interruptions. The system can prevent users from executing tests without the proper training records or if the instrument is due for calibration or maintenance work. Operators can approve and sign documents electronically, maintaining a permanent record, according to Principle 7 of HACCP.
LIMS allow seamless collaboration between teams spread across different locations. For instance, users from any facility or even internationally can securely use system dashboards and generate reports. When final testing is complete, Certificates of Analysis (CoAs) can be autogenerated with final results and showing that the product met specifications. All activities in the system are tracked and stored in the audit trail.
With features designed to address the HACCP principles and meet the ISO 17025 compliance requirements, modern LIMS enable manufacturers to optimize workflows and maintain traceability from individual batches of raw materials all the way through to the finished product.
Conclusion
To maintain the highest food quality and safeguard consumer health, laboratories need reliable data management systems. By complying with the ISO 17025 standard before the upcoming mandate by the FDA, food testing laboratories can ensure data integrity and effective process management. LIMS platforms provide laboratories with integrated workflows, automated procedures and electronic record-keeping, making the whole process more efficient and productive.
With even the slightest oversight, food manufacturers not only risk product recalls and lost revenue, but also losing the consumers’ trust. By upholding data integrity, LIMS play an important role in ensuring food safety and quality.
Safety is defined as controlling exposure for self and others. Going into 2020, the food industry battled safety concerns such as slips and falls, knife cuts, soft-tissue injuries, etc. As an “essential industry”, food-related organizations now face a unique challenge in controlling exposure to COVID-19. Not only must they keep their facilities clean and employees safe, they must also ensure they do not create additional exposures for their suppliers or customers.
These challenges increase at a time when employees may be distracted by stress, financial uncertainties, job insecurity, and worry for themselves and their families. Additionally, facilities may be understaffed, employees may be doing tasks they do not normally do, and we have swelling populations working from home.
While there is much we cannot control with COVID-19, there are specific behaviors that will reduce the risk of viral exposure for ourselves, our co-workers, and our communities. Decades of research show the power of behavioral science in increasing the consistency of safe behaviors. The spread of COVID-19 serves as an important reminder of what food-related organizations can gain by incorporating a behavioral component into a comprehensive exposure-reduction process.
Whether you have an existing behavior based safety process or not, follow these four steps.
It is critical to clearly pinpoint the behaviors you want to see occurring at a high rate. In the food industry, an organization must control exposure both within their facilities as well as during interactions with suppliers and customers. Controlling exposure within facilities will typically include those behaviors recommended by the CDC such as:
Maintain six feet of separation at all times possible.
Avoid touching your eyes, nose and mouth with unwashed hands.
Minimize personal interactions to reduce exposure to transmit or receive pathogens.
Frequent 20-second hand washing with soap and warm water.
Make hand disinfectant available.
Use alternatives to shaking hands.
Frequently clean and disinfect common areas, such as meeting rooms, bathrooms, doorknobs, countertops, railings, and light switches.
Sneeze and/or cough into elbow or use a tissue and immediately discard.
Conduct meetings via conferencing rather than in person.
If you are sick, stay home.
If exposed to COVID-19, self-quarantine for precaution and protection of others.
Supplier/Customer exposure-reduction behaviors will vary depending upon your specific industry and may include pinpointing the critical behaviors for food preparation, loading dock delivery, customer home delivery, and customer pick up. When creating checklists to meet your unique exposures, be sure the behaviors you pinpoint are:
Measurable: The behavior can be counted or quantified.
Observable: The behavior can be seen or heard by an observer.
Reliable: Two or more people agree that they observed the same thing.
Active: If a dead man can do it, it is not behavior.
Influenceable: Under the control of the performer.
Once you have drafted your checklists, ask yourself, “If everyone in my facility did all of these behaviors all the time, would we be certain that we were controlling exposure for each other, our suppliers, and our customers?” If yes, test your checklists for ease of use and clarity.
Step 2: Develop Your Observation Process
To do this, you will want to ask yourself:
Who? Who will do observations? Can we leverage observer expertise from an existing process and have them focus on COVID-19 exposure reduction behaviors or should we create a new observer team?
Where? Which specific locations, job types, and/or tasks should be monitored?
When? When will observers conduct observations?
Data: How will you manage the data obtained during the observations so that it can be used to identify obstacles to safe performance? Can the checklist items be entered into an existing database or will we need to create something new?
Communication: What information needs to be communicated before we begin our COVID-19 Exposure Reduction process and over time? How will we communicate it?
Step 3: Conduct Your Observations and Provide Feedback
Starting the Observation
Your observers should explain that they are there to help reduce exposure to COVID-19 by providing feedback on performance.
Recording the Observation
Observers should note on the checklist which behaviors are occurring in a safe manner (protected) and which are increasing exposure to COVID-19 (exposed).
Provide Feedback
Feedback is given in the spirit of reducing exposure. It should be given as soon as possible after the observation to reinforce protected behaviors and give the person to opportunity to modify exposed behaviors.
Success Feedback
Success feedback helps reinforce the behaviors you want occurring consistently. Effective success feedback includes:
Context: The situation in which the behavior occurred.
Action: The specific behaviors observed which reduce exposure to COVID-19.
Result: The impact of those behaviors on themselves or others—in this case, reduced COVID-19 exposure for themselves, their families and community.
“I care about your safety and do not want to see you exposed to COVID-19. I saw you use hand sanitizer prior to putting on eye protection. By doing that, you reduced the likelihood of transferring anything that might have been on your hands to your face which keeps you safe from contracting COVID-19.”
Guidance Feedback
Guidance feedback is given for exposed behaviors to transform that behavior into a protected one. Effective guidance feedback includes Context, Action, Result, but also:
Alternative Action: The behavior that would have reduced their exposure to COVID-19.
Alternative Result: The impact of that alternative behavior, such as reduced COVID-19 exposure for themselves, their families, and community.
“I care about your safety and do not want to see you exposed to COVID-19. I saw that you touched your face while putting on eye protection. By doing that, you increased the likelihood of transferring anything on your hand to your face which increases your risk of exposure to COVID-19. What could you have done to reduce that exposure?”
When giving guidance feedback, it is important to have a meaningful conversation about what prevented them from doing the safe alternative. Note these obstacles on the checklist.
Step 4: Use Your Data to Remove Obstacles to Safe Practices.
Create a COVID-19 exposure reduction team to analyze observation data. This team will identify systemic or organizational obstacles to safe behavior and develop plans to remove those obstacles. This is critical! When an organization knows that many people are doing the same exposed behavior, it is imperative that they not blame the employees but instead analyze what is going on in the organization that may inadvertently be encouraging these at-risk behaviors.
For example, we know handwashing and/or sanitizing is an important COVID-19 exposure reduction behavior. However, if your employees do not have access to sinks or hand sanitizer, it is not possible for them to reduce their exposure.
Similarly, the CDC recommends that people who are sick not come to work. However, if your organization does not have an adequate sick leave policy, people will come to work sick and expose their co-workers, customers and suppliers to their illness.
Your COVID-19 exposure reduction team should develop plans to remove obstacles to safe behavior using the hierarchy of controls.
Conclusion
Consistently executing critical behaviors is key to reducing exposure to COVID-19 as flattening the curve is imperative in the worldwide fight against this pandemic. Regardless of the type of behavior or the outcome that the behavior impacts, Behavior based safety systems work by providing feedback during the observations and then using the information obtained during the feedback conversation to remove obstacles to safe practices.
By using these tips, you can add a proven and powerful tool to your arsenal in the fight against COVID-19 and help keep your employees, their families, and your community safe.
N-nitroso compounds (NOCs), or nitrosamines, have once again made headline news as their occurrence in some pharmaceuticals has led to high profile product recalls in the United States.1 Nitrosamines can be carcinogenic and genotoxic and, in the food industry, can compromise a food product’s quality and safety. One nitrosamine in particular, N-nitrosodimethylamine (NDMA), is a highly potent carcinogen, traces of which are commonly detected in foods and may be used as an indicator compound for the presence of nitrosamines.2
NOCs can potentially make their way into the food chain in a number of ways, including (but not limited to): Via the crop protection products used to maximize agricultural yields; via the sodium and/or potassium salt added to preserve certain meats from bacterial contamination; as a result of the direct-fire drying process in certain foods; and via consumption of nitrates in the diet (present in many vegetables due to natural mineral deposits in the soil), which react with bacteria and acids in the stomach to form nitrosamines.3
The crop protection and food manufacturing industries are focused on ensuring that levels of nitrosamines present in foods are minimal and safe. Detection technology for quantitating the amount of nitrosamines (ppm levels) in a sample had not advanced in nearly 40 years—until recently. Now, a thermal energy analyzer (TEA) —a sensitive and specific detector—is being relied on to provide fast and sensitive analysis for players throughout the food supply chain.
Regulatory Landscape
Both NDMA and the nitrosamine N-nitrososodiethylamine (NDEA) have been classified by national and international regulatory authorities as ‘probable human carcinogens’.3 NDMA in particular is by far the most commonly encountered member of this group of compounds.7
In the United States there are limits for NDMA or total nitrosamines in bacon, barley malt, ham and malt beverages, yet there are currently no regulatory limits for N-nitroso compounds (NOC) in foods in the EU.7
Developers of crop protection products are required to verify the absence of nitrosamines or quantify the amount at ppm levels to ensure they are within the accepted guidelines.
Crop Protection
The presence of nitrosamines must be traced and risk-managed along the food’s journey from farm to fork. The issue affects testing from the very beginning – particularly at the crop protection stage, which is one of the most highly regulated industries in the world. Without crop protection, food and drink expenditures could increase by up to £70 million per year and 40% of the world’s food would not exist.7
Development of a new crop protection product (herbicide, fungicide, insecticide or seed treatment) involves several steps: Discovery and formulation of the product, trials and field development, toxicology, environmental impacts and final registration. New product registration requires demonstration of safety for all aspects of the environment, the workers, the crops that are being protected and the food that is consumed. This involves comprehensive risk assessments being carried out, based on data from numerous safety studies and an understanding of Good Agricultural Practice (GAP).
One global producer of agrochemicals uses a custom version of the TEA to verify the absence of nitrosamines or quantitate the amount of nitrosamines (ppm levels) in its active ingredients. The LC-TEA enables high selectivity for nitro, nitroso and nitrogen (when operating in nitrogen mode), which allows only the compounds of interest to be seen. Additionally, it provides very high sensitivity (<2pg N/sec Signal to Noise 3:1), meaning it is able to detect compounds of interest at extremely low levels. To gain this high sensitivity and specificity, it relies on a selective thermal cleavage of N-NO bond and detection of the liberated NO radical by the chemiluminescent signal generated by its reaction with ozone.
The customized system also uses a different interface with a furnace, rather than the standard pyrolyser, to allow for the additional energy required and larger diameter tubing for working with a liquid sample rather than gas.
The system allows a company to run five to six times more samples with increased automation. As a direct result, significant productivity gains, reduced maintenance costs and more accurate results can be realized.
Food Analysis
Since nitrite was introduced in food preservation in the 1960s, its safety has been debated. The debate continues today, largely because of the benefits of nitrite in food products, particularly processed meats.6 In pork products, such as bacon and cured ham, nitrite is mostly present in the sodium and/or potassium salt added to preserve the meat from bacterial contamination. Although the meat curing process was designed to support preservation without refrigeration, a number of other benefits, such as enhancing color and taste, have since been recognized.
Analytical methods for the determination of N-nitrosamines in foods can differ between volatile and non-volatile compounds. Following extraction, volatile N-nitrosamines can be readily separated by GC using a capillary column and then detected by a TEA detector. The introduction of the TEA offered a new way to determine nitrosamine levels at a time when GC-MS could do so only with difficulty.
To identify and determine constituent amounts of NOCs in foods formed as a direct result of manufacturing and processing, the Food Standards Agency (FSA) approached Premier Analytical Services (PAS) to develop a screening method to identify and determine constituent amounts of NOCs in foods formed as a direct result of manufacturing and processing.
A rapid and selective apparent total nitrosamine content (ATNC) food screening method has been developed with a TEA. This has also been validated for the known dietary NOCs of concern. This method, however, is reliant on semi-selective chemical denitrosation reactions and can give false positives. The results can only be considered as a potential indicator rather than definitive proof of NOC presence.
In tests, approximately half (36 out of 63) samples returned a positive ATNC result. Further analysis of these samples by GC-MS/MS detected volatile nitrosamine contamination in two of 25 samples.
A key role of the TEA in this study was to validate the alternative analytical method of GC-MS/MS. After validation of the technique by TEA, GC-MS/MS has been proven to be highly sensitive and selective for this type of testing.
The Future of Nitrosamine Testing
Many countries have published data showing that toxicological risk from preformed NOCs was no longer considered an area for concern. Possible risks may come from the unintentional addition or contamination of foods with NOCs precursors such as nitrite and from endogenous formation of NOCs and more research is being done in this area.
Research and innovation are the foundations of a competitive food industry. Research in the plant protection industry is driven by farming and the food chain’s demand for greater efficiency and safer products. Because the amount of nitrosamines in food that results in health effects in humans is still unknown, there is scope for research into the chemical formation and transportation of nitrosamines, their occurrence and their impact on our health. Newer chromatographic techniques are only just being applied in this area and could greatly benefit the quantification of nitrosamines. It is essential that these new approaches to quality and validation are applied throughout the food chain.
Hamlet, C, Liang, L. (2017). An investigation to establish the types and levels of N-nitroso compounds (NOC) in UK consumed foods. Premier Analytical Services, 1-79.
Park, E. (2015). Distribution of Seven N-nitrosamines in Food. Toxicological research, 31(3) 279-288, doi: 10.5487/TR.2015.31.3.279.
Crews, C. (2019). The determination of N-nitrosamines in food. Quality Assurance and Safety of Crops & Foods, 1-11, doi: 10.1111/j.1757-837X.2010.00049.x
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You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.
Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.
The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.
