United States: Earth Day 2023--Investing In A Balanced Approach To Emerging Contaminants

In the 1962 book, Silent Spring, Rachel Carson brought to the forefront of public attention contaminants of emerging concern (CECs). CECs, or emerging contaminants, are chemicals or materials that can be characterized by a perceived, potential or real threat to human health or the environment. These threats typically "emerge" as advances in scientific technologies reveal previously unknown adverse effects of a specific chemical that may already be ubiquitous in the environment. Examples in recent years include 1,4 dioxane, polychlorinated biphenyls (PCBs), ethylene oxide, and per- and polyfluorinated substances (PFAS). Pharmaceuticals and nanomaterials are increasingly being considered as areas of concern that may require further scrutiny in future.

Often by the time adverse impacts are identified, the contaminant is in widespread use. PCBs, for example, were prevalent in coolants and lubricants in a variety of electrical equipment because PCBs are very effective insulators. PFAS were heralded as revolutionary for their effective fire-fighting and coating characteristics and currently are in a multitude of everyday products ranging from food packaging to the clothes we wear.

As we gain a better understanding of the potential effects of these chemicals, regulators face challenges in promulgating appropriate regulations for these CECs. Meanwhile, companies seemingly acting in full compliance with permits and regulatory requirements find themselves targeted by lawsuits seeking to compel remediation of impacted sites and product reformulation. Long dormant sites previously considered remediated may be reopened and additional clean-up required as, for example, may result as a result of U.S. EPA's pending proposals to designate certain PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

As history has shown, and due to ongoing technological advancements, new emerging contaminants will continue to be identified and the process of evaluating potential health and environmental risks will begin anew. There is an ongoing debate as to whether the approach employed by the Toxic Substances and Control Act (TSCA) is the most effective approach to regulating CECs, when contrasted for example with the approach taken by the European Union's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). While both programs are designed to protect human health and the environment through restricting the use of harmful substances, they accomplish this through different means. TSCA requires reporting oversight of a chemical where U.S. EPA demonstrates an unreasonable risk. REACH, on the other hand, obligates manufacturers and importers to register and demonstrate the safe control of a chemical prior to that chemical being placed into the market.

As applied to PFAS, in the United States, U.S. EPA seeks to regulate specific PFAS through a variety of avenues. In August 2022, U.S. EPA proposed designating two PFAS substances as CERCLA hazardous substances, and in April 2023 proposed additional PFAS substance designations. In March 2023, U.S. EPA simultaneously proposed maximum contaminant levels (MCLs) setting drinking water limits for two PFAS compounds and proposed to regulate four additional PFAS through a Hazard Index screening approach that will require site-specific determinations for drinking water concentration. Pursuant to the 2019 PFAS Act, 176 PFAS substances have been added to the Toxic Release Inventory (TRI) chemical database, creating additional reporting liabilities for impacted companies. However, in December 2022, U.S. EPA proposed reclassifying all TRI-listed PFAS to the Chemicals of Special Concern list, which would further increase reporting scrutiny on regulated companies. Each of these practices takes significant resources to implement, and with 10,000 PFAS already identified, could create a significant investment over time.

Contrast this approach with the approach of the European Chemicals Agency (ECHA) that in February proposed a blanket restriction of all 10,000 PFAS substances in the European Union. This itself creates uncertainty for companies where no commonly accepted testing methods exist whereby companies can test for all of these compounds. The approach further restricts PFAS chemicals for which studies on their adverse impacts may not yet exist. It is expected that ECHA will receive a substantial number of comments on its proposal, much like U.S. EPA has received on its proposals discussed above.

While there may not be a single "right" way to address CECs, the risks posed by emerging contaminants will continue to challenge both the regulators and the regulated community to find the appropriate regulatory balance between protection of human health and the environment and the need to continue to manufacture products that we rely upon daily. As demonstrated by the 2016 Lautenberg amendments to TSCA, stakeholders on all sides appear invested to continue striving towards this balance.