The term “phthalate” denotes a class of chemicals that have been used since the 1920s to improve the flexibility and durability of plastic. Accordingly, phthalates can be found in hundreds, if not thousands, of everyday products, ranging from food packaging to toys, medical devices, construction materials, textiles, cosmetics, soaps, and fragrances. Their ubiquity has led some to nickname them the “Everywhere Chemical.”
Phthalates are coming under increased scrutiny due to growing concerns that they present long-term health risks. Phthalates such as di(2-ethylhexyl)phthalate (DEHP), butyl benzyl phthalate (BBP), and di-n-butyl phthalate (DBP), are suspected endocrine disruptors. There are also broader concerns that phthalates may have adverse impacts on the reproductive system and contribute to obesity and attention deficit disorder. These concerns have been recently publicized in mainstream outlets. For example, earlier this year, Simon and Schuster published the book Count Down by scientist Shanna Swan, which emphasized the potentially adverse impacts that phthalates may have on human fertility and development. This story was then picked up by leading media outlets such as The New York Times, Washington Post, ABC News, and The Economist. Concerns over phthalate exposure from food containers also rose during the pandemic, as Americans increased their consumption of takeout food.
Given their widespread use and the mounting concerns regarding human exposure, there is reason to believe that phthalates—and plastics in general—may be the next “hot topic” in environmental law. Indeed, there are parallels between the situation regarding phthalates today and that regarding poly- and perfluoroalkyl substances (PFAS) for several years. Therefore, it is worthwhile to consider the current regulatory and litigation landscape pertinent to phthalates.
Existing Framework for Federal Regulation of Phthalates
In a sense, the current framework for regulating phthalates at the federal level is more advanced than that for regulating PFAS. For example, the Consumer Product Safety Commission (CPSC) prohibits eight specific phthalates—including DEHP, BBP, and DBP—from being present in children’s toys at a concentration exceeding 0.1 percent by weight. Similarly, the Food and Drug Administration (FDA) requires that phthalate additives be listed as ingredients of cosmetic products.
The U.S. Environmental Protection Agency (EPA) regulates a variety of phthalates under various statutes, as described below:
- Phthalates are included on the EPA’s list of total toxic organics (TTOs) under Clean Water Act (CWA) section 304 and EPA has designated phthalate esters as toxic pollutants under Section 307(a)(1) of the CWA.
- The EPA has designated seven phthalates as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), thus subjecting releases of these chemicals to reporting obligations and Superfund Cost Recovery.
- DEHP, DBP, and dimethyl phthalate (DMP) are listed as hazardous pollutants under the Clean Air Act.
- Under the authority of the Safe Drinking Water Act (SDWA), EPA has issued health advisories for three phthalates and a conservative maximum contaminant level (MCL) of 6 ppb for a fourth, DEHP.
Particularly relevant to manufacturers are measures that EPA has taken to regulate phthalates under the Toxic Substances Control Act (TSCA). TSCA is the main statute that regulates the pre-market distribution of chemicals. EPA has subjected phthalates to heightened regulation under TSCA over the past decade or so and appears poised to impose further restrictions.
For instance, in 2009, EPA released its Phthalate Action Plan, which proposed a path forward for regulating the eight phthalates believed to present the greatest health and safety risks. In 2014 EPA added seven of these phthalates to its list of TSCA Work Plan chemicals for risk evaluation and, in 2019, designated six of these chemicals (DBP, BBP, DEHP, DIBP, DCHP, and phthalic anhydride) among the twenty “high-priority” substances for risk evaluation under TSCA. Based on the outcome of the risk evaluations, EPA may use its authorities under other provisions of TSCA, including Section 6, to restrict the use of phthalates in domestic commerce. Most recently, on April 28, 2021, EPA added five phthalates (BBP, DBP, dicyclohexyl phthalate, DEHP, and DIBP) to its Priority Testing List under TSCA Section 4(e). This action obligates manufacturers and processors of phthalates to perform testing of the pertinent phthalates and to report the results to EPA, which will then use the data as part of its risk evaluations.
As is the case with PFAS, certain states are striving to outdo EPA in terms of the stringency of phthalate regulation. For example, seven states (California, Kansas, Kentucky, Minnesota, Montana, New Jersey, and North Carolina) have followed EPA’s lead and established water quality standards for DEHP, but with more stringent criteria than EPA. Moreover, nine states (Alaska, Arizona, Kansas, Kentucky, Maine, Minnesota, Montana, New Jersey, and North Carolina) have adopted their own water quality standards, guidance values or exposure guidelines for phthalates not yet regulated by EPA. The emerging patchwork of state regulatory standards is likely to create permitting and enforcement confusion for members of the broader regulated community, but also for EPA.
Other states, including California and Washington, have prohibited the use of phthalates in consumer products. The recent developments in this area are particularly noteworthy. For example, in 2019, Maine passed the Toxic Chemicals in Food Packaging act, prohibiting food packaging that contains intentionally introduced amounts of phthalates, and in 2020, California became the first state to pass a law (AB 2762) banning cosmetic and personal care products with intentionally added plasticizers—including phthalates. Since 2020, bills restricting phthalates in consumer products have been introduced in Minnesota, New Jersey, New York, and Vermont. These initiatives partly reflect consumer habits during the COVID-19 pandemic, as the use of takeout containers—and corresponding concerns about the effects of plasticizers in food contact materials—has skyrocketed.
The Evolving Phthalate Litigation Landscape
Phthalate litigation is also on the rise. In June 2020, a consumer advocacy group, filed a California Proposition 65 lawsuit against Best Buy, requesting an injunction mandating Best Buy warn of the presence of DEHP in suction cup camera mounts sold by the company. The suit was settled in less than six months, but the wave of phthalate litigation has only just begun. In April 2021, plaintiffs sued General Mills in California and New York, alleging the company falsely advertised its Annie’s macaroni and cheese products by failing to disclose the presence of ortho-phthalates despite “using a marketing and advertising campaign centered around claims that appeal to health-conscious consumers.” Plaintiff groups sent one hundred and twenty-two CA Prop 65 Notices in March 2021 for alleged phthalates in consumer products, including plastic bags, purses, goggles, gloves, coolers, badminton sets, tennis grip tape, and hangers and tongs with vinyl grips.
Federal and state agencies and legislatures are expected to continue their scrutiny of phthalates and to subject them to heightened regulation. As the science around phthalate-related health risks develops, states may follow California and other jurisdictions with existing phthalate laws in banning specific applications of these chemicals. What remains unknown is how EPA will regulate phthalates going forward, for example, as new testing data is utilized in the development of TSCA risk evaluations. Similarly, better understanding of the health risks associated with phthalates may reasonably be expected to spur private litigation.
The implications of this burgeoning trend may prove to be significant for companies that manufacture or process phthalates. Despite the nascent and disparate state of phthalate regulation across different states, it is not too soon for companies to begin taking proactive measures to better understand any potential liabilities that they may stand to incur. Such measures may include internal investigations or audits to understand the presence of phthalates in products or supply chains, as well as actively staying abreast of legal developments and even participating in current and future rulemaking processes. Pillsbury has experienced environmental practitioners that can assist in all such facets.