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
Honey continues to be a popular target for fraudulent activity, as this latest case shows. A large number of batches of honey imported into Greece from inside and outside the European Union contained adulterants like added sugars and prohibited caramel colors, which was proven by chemical analysis. Honey produced in Greece was not affected. The adulterated products were immediately withdrawn from the market and the public was advised not to consume them.
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).
Last week President Biden signed the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act; H.R. 1202) into law. The bill is a significant victory for food allergy advocates, because it adds sesame to the list of allergens that must be labeled on food packaging. HHS must also report certain information related to food allergy research and data collection.
Sesame is the ninth food allergen that must be labeled on food packaging. According to FARE (Food Allergy & Research Education), a non-government food allergy advocacy group, about 1.6 million Americans are allergic to sesame. “Sesame is often used when a label reads ‘natural flavors’ or ‘natural spices’, adding another layer of difficulty when consumers review product labels at their local grocery store,” according to a FARE press release about the bill. “This marks the first time since 2004 that a new allergen has been added to the Food Allergen Labeling and Consumer Protection Act (FALCPA).”
Packages must include the updated labeling by January 2023.
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
In a large case of trademark violations and counterfeiting, Haldiram, the leading snack manufacturer from India, filed a lawsuit against a Georgia-based distributor. The distribution company misused the well-known Haldiram label to import, distribute and sell counterfeit beverages, snacks, beverages and ready-to-eat meals in the United States, which is a large market for Haldiram. The company is seeking significant amounts of money for damages caused by the distributor and an immediate stop to the trademark infringements.
We all know it is important to maintain a healthy work-life balance, regardless of our current career stage. We also know that this can be a challenge. In March 2020 when coronavirus restrictions forced the various aspects of our lives—normally kept separate—to collide in our kitchens and spare rooms, we found ourselves sharing workspace with partners and children. This immediate change really brought our work-life balance into focus.
As part of our Women in Food Safety series, we interviewed three highly successful food safety professionals about how they keep their work-life balance in perspective despite the ever-increasing demands of work, and how they have tackled major life changes or career decisions along the way, while still keeping their career on track.
We were delighted to have the opportunity to talk to Shawna Wagner, food sector and technical manager, North America for DNV and SQF Auditor of the Year, 2019; Cornelie Glerum, director of operations for FSSC 22000 and Laura Gutierrez Becerra, food safety regulatory and operations manager at Amazon. These outstanding professional females work in different sectors of the industry and have different career backgrounds, but they all agreed on the importance of keeping a healthy work-life balance and shared surprisingly similar strategies for tackling it. They also agreed that it is all too easy to let work consume your life, so above all, it is very important to like your job and to do something that you enjoy.
It is clear that achieving highly aspiring career goals requires disciplined time management both at work and at home; and it is also important to build a support network of others that can help you. Similarly, although at the start of a career one might think it a sign of weakness to ask for help, this is not true. If there comes a time when it seems impossible to get everything done, be kind to yourself—some tasks can always wait.
Shawna Wagner is a senior auditor so traveling is a major element of her job. Before COVID -19 hit, she might be on the road 270 nights a year. ” This definitely eats into personal time and takes a toll on family life- it is important to switch off at times” she said.
As the director of operations, Cornelie Glerum is a founder, and leading force behind FSSC 22000. She believes that “Work life balance is very important—and that you should work to live—not live to work”.
Laura Gutierrez Becerra has had an interesting and varied career path, which has covered career moves, an international relocation, a family-focused career break as well as the raising of three children before reaching her current position with Amazon. “Work-life balance is important to keep in check. I think that as women, we can forget about ourselves, particularly as we tend to be fully dedicated to our job or career path, or we have family responsibilities or dependents to care and provide for. We tend to put considerations for ourselves last.
There are elements and approaches to maintaining a work-life balance that all of them agreed upon.
1. Keep a personal schedule as well as a work schedule
It is easy to let work overwhelm or occupy your all your time, so it is important to make personal appointments with yourself or your family.
Shawna Wagner, DNV
Wagner: I certainly try to schedule something every weekend, such as golf, camping, and dinner events. The scheduling is important as if it’s not in my phone calendar, it’s not happening.
Glerum: I have a family, a partner and two young children, and we do have some family commitments that are on a set schedule such as the Friday hockey practice, which is an important part of my week, as I enjoy being the coach. If they are written into the schedule, it is easy to keep the commitment.
Gutierrez: I am fairly good with this now compared to when I started my career. We had to create schedules for everyone in the family to have responsibilities in the home so that the chores got done, but we also factored in extra-curricular activities such as family game night, etc. We also enjoy exercising together, which is important for us all.
2. Taking time off
Wagner: I have come to learn that vacation time is your time to shut work off, and I was extremely poor at this practice. I would take vacation but still work all day on emails, so I didn’t fall behind for when I was back from vacation. My best advice is to know that it will still be there when you get back and to train others to cover for you for when you are not in the office. Also return the favor for others, as we all deserve downtime.
Laura Gutierra Becerra, Amazon
Gutierrez: There was a point in my career when I was juggling job moves raising children with different ages (an infant, a toddler and a teenager) , and I felt burnt out. I took the great piece of advice from my mentors who advised me to do more of the hobbies that I enjoy, and to learn to delegate. Although this was difficult at first, it was helpful to consider delegation as a way of helping others to develop and advance their careers. Looking at it from this [perspective] allowed me to take some time off.
3. Keep your phone in check. While of course it is a life-changing invention, the cell phone is also the never-ending connection to work.
Wagner: I keep things in perspective by always having dedicated time to my family and friends. For example, if I am having dinner with my partner, it’s a hard rule that I will not answer the phone.
Glerum: I am aware that I have big responsibilities in my job, so I do tend to stay in touch and keep my phone on even during holidays and vacations, but I try to keep calls at the minimum.
4. Asking for help
Wagner: It is important to ask for help, and if you can find others who want to learn, then it helps them also. When I was new to the industry, I wouldn’t ask for help, as I wanted to show that I could achieve success by myself or seek the right answer for the solution, and I realized that this might not be the good way. We all need to learn to be comfortable to ask for help.
Cornelie Glerum, FSSC 22000
Glerum: Yes, I can ask for help, and I am fortunate to have my parents close by so I can ask to help with children if I am at work or traveling. I also have good neighbors that can step in, and this works both ways. This is truly a valuable support network, and we all help each other with reciprocal arrangements.
Gutierrez: I was not good at the delegating tasks at the beginning. As I had relocated from Mexico to the United States, I did not have any close family here to call on. Also, as is typical of my Mexican culture, I felt I had to do everything myself for my family at home as well as demonstrating at work that I was on top of my game. This was completely wrong and quite self-defeating. Today, I am better at prioritizing and delegating. Developing new networks has also helped me both on a personal as well as professional level. When I moved from Mexico, I didn’t even know how and where to start. However, I have worked specifically to build supportive circles such my “kindergarten mothers”, my “Mexican coffee chat” and of course, my great “Women In Food Safety” network”.
Other Advice We Want Share
Glerum: It is important to recognize that not all jobs need to be done all of the time, and if you are heavily committed at work, some chores just might not get done. While you might be a high achiever, you do not need to set the bar so high for everything. Maybe you do not get all the cleaning done on time in the house, give yourself a break. If the laundry is becoming an issue, and the children are running out of clean clothes—add to the wardrobe, buy more socks for the children!
Gutierrez: Going through life-changing events and overcoming challenging moments for sure gives you resiliency and provides realization that we women can overcame many things. I have had several major changes in my home life. However, I can fully relate to the expression: “A women is like a tea-bag, you don’t know how strong she is until you put her in hot water” by Eleanor Roosevelt.
Preparing to Start Your Career? Here’s Some Advice
Wagner: Women can do any job and can be developed to achieve their goals. Women also provide an important perspective to the mixture of different people with whom you work. The field of food safety also is open to many career aspirations. I recently did an audit at a facility where a young lady was the maintenance manager. She rocked that shop!
Glerum: As women, we have a range of different skills and strengths in the workplace. We are good with precise details, are conscientious and demonstrate accuracy, which is important in my business as a certification program owner. We should use these different attributes to our own advantage in the workplace without compromise. However, women often do not always have enough confidence in their abilities and are sometimes afraid to speak up, especially in a man’s world.
Women also add an “elegance” for want of a better world, which can add to the comfort and refinement to the workplace. For example, we are more likely to remember birthdays and see the importance of staff appreciation, sharing gifts etc. This makes a nicer workspace for everyone.
Gutierrez: Do not to be afraid of asking questions. I initially lacked confidence to ask questions. Also, ask for feedback. It is very important and always helpful, whether it is positive or negative, learn from it and actively apply this learning. Always be open to new opportunities, be inquisitive about other areas. If you do not see opportunities for learning and development, move on to somewhere else if you can. Constantly, assess your aspirations and determine what is your main drive.
Do what you like and like what you do!
Women are an important element in the workplace and the home. Balancing work, life and the demands of a family can take a heavy toll. However, supporting networks can help. Feel free to reach out to Women in Food Safety so we might offer some support and advice—you are never alone.
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
Adulterated alcohol continues to pose serious risks to health and even life of consumers. In this latest case from the Dominican Republic, more than two dozen people have died from methanol poisoning due to a low-cost illegally made drink, and from fake brand-named products. Businesses associated with the scams were raided and closed, and arrests were made. Officials keep warning against the consumption of illegally manufactured alcoholic beverages.
Futurist Ross Dawson has said that AI and automation will shape the future of work, and it also promises to transform our lives beyond the office. According to the World Economic Forum, when AI, which provides the ability to “enable devices to learn, reason and process information like humans,” is combined with Internet of Things (IoT) devices and systems, it creates AIoT. This super duo has the potential to power smart homes, smart cities, smart industries and even our smartwatches and fitness trackers, a market estimated by Gartner to be worth $87 billion by 2023. More importantly, this “interconnectedness” will change the way we interact with our devices as well as the way we will live and work in the future.
In the restaurant industry, we’re already seeing glimpses of this interconnectedness take shape, and in the past year, we’ve experienced major technological advancements that have transformed every facet of the way food establishments work. Reflecting on those advancements, I want to take a moment to share three areas of AI impact that are bubbling up in the restaurant sector in 2021.
1: AI-powered Intelligent Kitchens
From ghost kitchens to traditional kitchens, the “back of the house” continues to be a prime target for AI and automation. While great progress has been made, in many ways it seems like we’ve only scratched the surface when it comes to how far AI can take today’s restaurants. But every now and then, we hear examples of AI powering the future of our industry. For example, Nala Robotics, Inc. will be opening what it calls “the world’s first state-of-the-art intelligent restaurant” in Naperville, Illinois this year. The company says the AI-based robotic kitchen “can create dishes from any cuisine around the world, using authentic recipes from celebrated chefs”. A press release from Nala Robotics states that its flagship restaurant is taking “the first step in the food service industry with AI-powered service, addressing many of the issues affecting restaurant owners during COVID-19,” and it will “provide consumers an endless variety of cuisine without potential contamination from human contact.” This is the new frontier in intelligent kitchens, and it couldn’t have come at a better time, with the pandemic forcing restaurants to reimagine the way they do business.
2: AI-Driven Labor Shifts.
You can’t talk about AI in the restaurant industry without also having a conversation about the implications for the modern workforce. With AI in restaurant kitchens and beyond, the impact on the labor force is undeniable. By 2024, Gartner predicts “that these technologies will replace almost 69% of the manager’s workload.” But that’s not entirely a bad thing. Instead of manually filling out forms and updating records, managers can turn to AI to automate these and other tedious tasks. “By using AI…they can spend less time managing transactions and can invest more time on learning, performance management and goal setting,” Gartner adds.Managers can also use the extra time to focus more effort on the customer and employee experience. And indeed they should: In a recent Deloitte report, 60% of guests surveyed indicated that a positive experience would influence them to dine at a restaurant more frequently.
Looking at the impact of AI on labor at all levels, from the CEO to the entry-level wage earner, the shift, at its best, will be a transition to more meaningful—and less mundane—work. The evolution of humanity has taken us to the point we’re now at now, with food production and delivery processes becoming increasingly automated. This has been an evolution generations in the making. In an ideal world, everyone at every level of the organization should benefit from this new wave of technology. For example, automation can and should be used to open the door to new training and new opportunities for low-wage earners to learn new skills that elevate career paths, increase income and improve quality of life.
3: AI and Global Supply Chain Transformation
From the farm all the way to the table, AI is now poised to transform the global supply chain. From my perspective, the biggest impact will be around driving sustainability efforts. Restaurant and grocery brands are already beginning to leverage AI to forecast their food supply needs based on customer demand, leading to less over-ordering and less food waste to support sustainability initiatives. One company in this space, FourKites, is creating what it calls “the digital supply chain of the future.” Using real-time visibility and machine learning, FourKites powers and optimizes global supply chains, making them “automated, interconnected and collaborative—spanning transportation, warehouses, stores, trucks and more.”
In addition to predictive planning, more and more brands will start to use AI to create incident risk management models to identify trends and risks in the supply chain to determine whether bad or recalled products are originating from a specific supplier, distributor, or due to an environmental variable.With all of these changes, the need for comprehensive data standards will multiply as suppliers and distributors around the world work together to bring us produce and packaged food from all corners of the globe. Data standards will be critical to traceability and the exchange of critical tracking events and key data elements, and advances in data standards will power the meta-data needed to provide better insight for food quality and regulatory compliance, crisis management, and recalls—at scale.
Research firm Forrester states that, in the end, the greatest impact resulting from an investment in robotics and other technologies that automate operational tasks is improved customer experience (CX). “Most companies believe that investment in AI, automation, and robotics for engagement will decrease operational costs. While this is true, our research shows that the revenue upside from delivering better CX could deliver a greater impact on the bottom line over time,” Forrester states.
As a business engaged in digitizing and transforming supply chain operations, our team couldn’t agree with Forrester more. But we believe it will take striking the right balance between technology and the human touch to not only drive stronger CX, but to also create a world in which AI is implemented for the greater good—a world in which people, processes, business and technology all win.
Known officially as The California Safe Drinking Water and Toxic Enforcement Act of 1986, California Proposition 65 reaches far beyond state boundaries and has potential regulatory implications for almost any company that manufactures, imports, and / or sells products containing listed chemicals in the state. California Prop 65 prohibits the sale of a product in California that knowingly and intentionally exposes an individual to a California Office of Environmental Health Hazard Assessment (OEHHA) listed chemical without a specific stated warning. For many food and supplement companies, the risk of opportunistic litigation based on California Prop 65 drives the need to monitor updates, new amendments and enforcement of the law.
Prop 65 Background
California Proposition 65, also known by the shortened name Prop 65, is not a ban on products or ingredients. The law is intended to inform consumers in California about exposure to a list of chemicals exceeding a defined level in products for sale, including product packaging. The regulation mandates a warning label for exposure to chemicals at a level that could cause cancer, birth defects or other reproductive harm. Guidance for upper limits (“Safe Harbor Level”) on chemicals is based on expected daily exposure. If no Safe Harbor Level exists for a chemical, the product containing a listed chemical must include a warning, unless the exposure level can be proven to not pose a significant risk of causing harm.
With the size of the California economy and the interconnected U.S. supply chain, the state law effectively reaches other states and U.S. importers. More recently, the Prop 65 requirements impact online and catalog sales, which have increased significantly during the global pandemic.
Know Your Suppliers
All companies need to proactively evaluate and document Prop 65 risks. Enforcement occurs primarily through civil litigation, resulting in specialized legal firms profiting from a company’s ignorance of the law’s extent. Even the threat of publicity from a lawsuit can cause targeted companies to settle a case.
At each point of manufacturing and distribution—supplier, manufacturer, packager, importer or distributor—regulatory teams should ask about Prop 65 compliance. The main point of responsibility is at the manufacturer, but a retailer can also be obligated for introducing a chemical at point-of-sale.
What’s New with Prop 65
The OEHHA issues notices regarding amendments to the California Code of Regulations Title 27, Article 6, covering “Clear and Reasonable Warnings”. Recently the OEHHA requested public comments on proposed amendments that would modify the content and methods for providing “short-form” warnings. The short form was originally intended for products with restricted label space.
The proposed rule would modify the existing short-form warning provisions to:
Only allow use of the short-form warning on products with five square inches or less of label space.
Eliminate use of short-form warnings for products sold via the Internet and catalogs.
Clarify how short-form warnings can be used for food products.
Require the name of at least one chemical be included in the short-form warning.
Bottomline: Know Your Business and Risk
As an advisor with more than 20 years of regulatory compliance experience in food and food ingredients, my guidance for business best practice on Prop 65 is to be proactive, maintain supply chain knowledge, and understand risk. Regulatory or legal staff, or consultant teams specializing in Prop 65, should regularly monitor for additions to the chemical list and rulemaking changes to the far-reaching law.
Following the report released by Congress in February regarding an alarming amount of toxic heavy metals found in baby food, the FDA has released an action plan that aims to reduce the presence of those dangerous metals to the “lowest possible levels” in common foods consumed by babies and young children. The “Closer to Zero” plan takes research, regulatory and outreach into consideration and will use the following approach:
Evaluating the scientific basis for action levels. FDA will evaluate existing data from routine testing of food, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
Proposing action levels for specific toxic elements in baby food categories that include cereal, formula, and pureed fruits and vegetables.
Working with stakeholders and federal partners on proposed action levels— including collecting data and information from workshops and scientific meetings—and assessing the feasibility of the proposed action levels and timeframes for achieving them. The FDA will use and monitor the information to finalize the action levels.
“Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children,” stated Janet Woodcock, M.D., acting FDA commissioner and Susan Mayne, Ph.D., director of CFSAN. “During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan.” Phase 2 runs from April 2022 until April 2024 and will expand the agency’s work into cadmium and mercury, as well as finalize action levels for lead. Phase three and beyond begins in April 2024 and will finalize action levels for arsenic.
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
Lab methods for the analysis of adulterated food can be time-consuming, expensive and impossible to use in the field. A new study shows promising results for hand-held near infrared (NIR) spectroscopy tools. The investigated method proved to be very quick and highly accurate, and could open new possibilities for remote testing. This was shown in a study with oregano samples, a common target for food adulteration.
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