Mounting public and regulatory concerns regarding widespread phthalate exposure may result in a rapid expansion of regulatory and litigation risk for impacted businesses.
Phthalates are chemicals found in a wide range of consumer and industrial products, and public consciousness regarding the health risks they pose is quickly mounting.
As demonstrated in the case of PFAS, growing public concerns about chemical exposure can result in the widespread adoption of disparate regulatory standards and create unexpected litigation risks.
Some phthalates are already subject to regulation under federal environmental statutes, and some states have recently taken measures to restrict the use and disposal of phthalates.
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.
I. 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 United States 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.
JD Supra, 16 June 2021