Tag Archives: materials

magnifying glass

Surveying the Phthalate Litigation Risk to Food Companies

By Kara McCall, Stephanie Stern
1 Comment
magnifying glass

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

Background

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

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

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

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

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

Phthalate Litigation

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

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

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

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

References

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

Seaweed-Based DNA Barcodes Trace Food Throughout Supply Chain

By Food Safety Tech Staff
No Comments
SafeTraces

Having the ability to apply barcodes directly to food could change the game of food traceability. One company has developed a patented technology that involves applying a DNA barcode directly to raw materials and finished product to enable traceability of a product throughout the entire supply chain.

Last month SafeTraces, Inc. was granted a U.S. Patent for a new method that encodes and decodes digital information to and from DNA strands. Called safeTracers, these seaweed-based DNA barcodes have been deemed generally recognized as safe (GRAS) by FDA, are non-GMO and Kosher, and can be applied to all food and beverage products, according to SafeTraces. The DNA barcodes were initially developed for low margin industries such as fresh produce, and bulk foods and grains. The safeTracers are generated via the company’s IoT miniDART solution, which creates a unique batch for each lot of product. They are directly applied to food during processing, giving the food item or batch of commodity food a unique tag that contains traceability information.

This technology could be fill a critical piece of the puzzle during a recall, as information about a product could be accessed within minutes.

Angela Anandappa, Alliance for Advanced Sanitation

Advances in Hygienic Design

By Angela Anandappa, Ph.D.
No Comments
Angela Anandappa, Alliance for Advanced Sanitation

The industry is taking notice and being more proactive in hygienic design thinking. Hygienic design is not a very new concept; in fact, it’s been around for almost a century when the dairy industry realized standardization was helpful with different parts. When the 3-A Sanitary Standards Inc. (3-A SSI) was established in 1920, the ideals for hygiene revolved around dairy handling equipment. But today, these hygienic design principles have been adapted by other industries, and new expectations for cleanability and standards have been developed by both 3-A and the European Hygienic Engineering and Design Group (EHEDG).

Geometry Is at the Core of Cleanliness

One of the most important factors that have helped the food industry in improving hygienic design is the use of geometry. How does math play such as huge role in hygiene? Hygiene, in the context of hygienic design for the food industry, takes the form of advanced materials formed into specific geometric positions to prevent the adhesion of particles and bacteria. A fraction of a degree angle changed in a cutting edge can make the difference between a smooth cut on a vegetable that allows it to swiftly slide off, thereby allowing the same cutting edge to be reused many more times than a cutting edge with a slightly different angle. This offers a functional benefit in achieving the optimal product quality while also reducing contact with the product and extending the time where buildup needs to be cleaned. The minimum radius of a corner for equipment parts and flooring are well defined for optimal water drainage. Similarly, the slope of a surface, the distance to angle ratios for otherwise horizonal liquid handling tubing, or the height and vertical sloping angles of a drain suitable for a processing zone are all key criteria that define hygiene. The scientific basis for why a certain angle works better than another for a specific purpose is continually being investigated to further improve design.

Standards and Guidelines Converge for Global Harmony

The effort by 3-A and EHEDG to harmonize design standards and guidelines respectively, is bringing about a convergence of approaches that benefits equipment manufacturers. EHEDG with its network of research institutes is capable of providing strong scientific principles upon which standards could potentially be developed or further enhanced. By working together to harmonize standards and guidelines, equipment manufacturers have even more incentive to adopt hygienic design principle. The 3-A SSI offers the 3-A Symbol authorization which helps third parties readily recognize that the equipment conforms to a given 3-A Sanitary Standard for equipment. So an original equipment manufacturer (OEM) is then not only encouraged to adopt hygienic standards, but also incentivized by the breadth of technical data available to them, making the excuse of costs associated with adhering to 3-A standard or EHEDG approval a thing of the past. Given that food safety depends on preventing contamination, new equipment or modifications that do not work to maintain hygiene are risks to the product.

In this new age, an equipment purchase that lacks the third-party nod of approval by a hygienic standards organization is a liability.

Equipment designed to be more easily wet cleaned by allowing for rapid disassembly while not always integrated into standards, is generally understood as a must for modern equipment. Moving equipment in and out of a single-use room for multiple processes is another benefit provided by equipment designed to accommodate quick changeovers. Accessibility is the key to cleaning success, as operators need to be able to fully access, clean and inspect the cleanliness of the equipment. Specifications for easements around equipment for cleanability are important.

Regulatory Requirements Should Inspire Equipment Design

FSMA brought sweeping changes to finally update the federal requirements for food safety that pointed to key areas that promote the use of sanitary conditions for producing, handling and transporting food. Prior to this, the meat industry had already been driving numerous best practices to cleaning equipment that have brought USDA inspected facilities a long way. The dairy industry’s focus on hygiene has been the gold standard for liquid handling, and the Pasteurized Milk Ordinance (PMO) set expectations for makers and inspectors to be familiar with good hygienic design, requiring it when it was absent.

But regulations always seek to provide broad guidance that is better executed by non-profits, NGOs and companies that serve to encourage adherence to standards, or those playing a pivotal role in buying decisions. Closely examining the U.S. Code of Federal Regulations and its references to sanitary design points to a vision for improving the state of equipment, facilities and transportation conditions to meet a higher threshold for hygiene that needs to be integrated into engineering designs by the OEM.

Materials Make All the Difference

Stainless steel has been used for over a century and is the standard metal used widely due to its corrosion resistance, formability and ability to be polished and renewed. The Nickel institute reports that two thirds of global nickel production is used in manufacturing stainless steel, forming an alloy that is suitable for food contact equipment and in healthcare.

The hygienic character of the material is directly proportional to the cleanability, moisture resistance and corrosion resistance. Rounded corners, super smooth finishes, slopes and numerous other criteria have been defined for a variety of equipment, surfaces, flooring, etc., in combination with a plethora of materials that provide water resistance, antimicrobial activity, metal detectable or flexible disposable seals, novel elastomers that provide heat resistance for O rings and joints have brought design to a higher level of sophistication than ever before.

Similarly, metallurgy is another area in which innovative alloys have been developed for softer or harder parts of a variety of equipment. Not all stainless steel is the same and while a 304 grade stainless steel works for most food contact equipment, other grades of stainless steel find their best uses in certain other parts of a hygienic facility. And pulling it all together, the design criteria for metal joints, especially those that come into contact with food, are best put together by skilled technicians who understand micro resistance design that promotes food safety.

Education and Awareness

The revolutionary aspect of today’s hygienic design really has more to do with a concerted effort to focus the industry on prevention. Several noteworthy contributions to this effort lay in the hands of organizations like the American Institute of Baking (AIB), North American Meat Institute (NAMI), American Frozen Food Institute (AFFI), and Commercial Food Sanitation (CF-SAN) that have individually or through partnerships with other key organizations, elevated the level of knowledge, accessibility of training and awareness that solid hygienic design for facilities and equipment are the foundations for prevention. And so, as we move forward, this really is an exciting time to be a student of good design and apply engineering talents to the food industry.

Third-Party Assessments

Hygiene can be defined as a set of activities or behaviors geared at preventing disease. Some of the earlier well documented instances of hygiene (or lack thereof) relating to food have their roots in cholera, dysentery associated with the industrial revolution and the need for human beings clustering into smaller and more populated regions, namely cities. But the notion of personal hygiene is inextricably joined to the production of food and will remain so for the foreseeable future. Assessing the hygienic condition of a food production environment is not the same as a food safety audit. To elaborate, a hygienic assessment requires comprehensive knowledge of sanitation systems, equipment design and evaluation criteria, which although included in general terms, are not well scoped in any of the GFSI schemes. In fact, facilities that have passed certain GFSI audits frequently fall seriously short on their ability to produce safe food.
A specialized hygienic assessment is a worthwhile option for big buyers, food service giants and large-scale processors to drive for predictable quality. These specialized audits conducted by organizations that have developed a focus for equipment design are being more frequently utilized as a preventive measure. When done right, they can also be powerful tools for driving positive food safety culture and developing long-term supplier relationships.