There have been a number of important recent developments, with more on the way, concerning emerging contaminants such as Per- and Polyfluoroalkyl Substances (PFAS) and 1,4-dioxane. It can be hard for companies to discern, respond to, and plan for the practical impact of these developments on their regulatory compliance, environmental cleanups, litigation, and day-to-day business operations.
We’ve highlighted a few key developments and some corresponding recommendations for organizations to prepare for what’s ahead for emerging contaminants.
- Navigating New Reporting Obligations: The forthcoming Toxic Substances Control Act (TSCA) Section 8(a) reporting rule will create significant challenges for businesses that used any amount of PFAS chemicals in the last 12 years, not only because it may be very difficult to comply with the reporting requirements, but also because the broad disclosure of information could influence public perception of the safety of particular products.
- Shifting Regulatory Landscape: The US Environmental Protection Agency (EPA) continues to aggressively move forward with meeting its PFAS Roadmap objectives.
- Recommendation: Interested parties, industry, and stakeholders can benefit from monitoring EPA’s continued regulatory action to be better situated to evaluate effects on their businesses, reporting obligations, and day-to-day operations. Where EPA’s planned actions require rulemakings by the agency, interested parties should consider whether submitting comments and actively partaking in these rulemakings would be beneficial.
- Exemption and Exclusion Removals: While intended to enhance reporting, the removal of exemptions and exclusions for toxic chemical reporting relating to PFAS under the TSCA, such as EPA’s proposed removal of the de minimis exemption for reporting PFAS under its Toxics Release Inventory (TRI) program, will also likely lead to increased challenges to businesses handling PFAS.
- Setting Precedents: EPA is on track to list Perfluorooctanoic acid (PFOA) and Perfluorooctane sulfonic acid (PFOS) as Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) hazardous substances by summer 2023. This precedent-setting listing would affect a broad range of industries and businesses, including adding requirements for reporting of releases, expansion of existing Remedial Investigation & Feasibility Study investigations and remedies, possible reopeners of existing remedies, and likely increases in cost recovery and contribution litigation.
- Recommendation: Businesses can begin to prepare now by investigating potential risks from current and historic site operations and protecting against possible future liability in settlements and acquisitions in anticipation of this listing.
- Tension Between Sound Science and Demand for Regulation: There is a risk that forthcoming legislation and regulation of PFAS could get out in front of the science; in particular, by treating PFAS as a group and without regard for differences among the thousands of PFAS chemicals.
- Additional Toxicity Assessment: In addition to the recently released final toxicity assessment for GenX, EPA and Integrated Risk Information System (IRIS) intend to issue final toxicity assessments for five additional PFAS (PFBA, PFHxA, PFHxS, PFNA, and PFDA) within the next year, which can in turn be used to set related health advisories.
- Recommendation: Stakeholders will want to monitor how EPA and IRIS will handle the lack of human epidemiological data for a number of these lesser-studied PFAS (compared to PFOS and PFOA) and whether EPA and IRIS will be required to more heavily rely on animal toxicological studies. Stakeholders will also want to keep an eye on possible effects that the more robust human epidemiological data sets may have on pending and future risk assessments as EPA undertakes additional studies under its national PFAS testing strategy, and whether they lead to tighter restrictions and risk analyses.
- Impacts on Litigation: The new data EPA is cultivating and developing through ongoing studies and reporting by parties will likely influence both pending and future litigation surrounding PFAS.
- More Regulation: Further regulation of other emerging contaminants, including 1,4-dioxane, is anticipated as EPA completes its pending TSCA risk assessments and continues to focus on reducing contamination of waterbodies.
If you are interested in Emerging Contaminants—The Road Ahead, as part of our Earth Day Webinar Series, we invite you to subscribe to Morgan Lewis publications to receive updates on trends, legal developments, and other relevant areas.