Can Chemical Class Approaches Replace Chemical-by-Chemical Strategies? Lessons from Recent U.S. FDA Regulatory Action on Per- And Polyfluoroalkyl Substances.

Abstract

Concern about the toxicity and exposure of per- and polyfluoroalkyl substances (PFASs) is growing among scientists, regulators, and residents of contaminated communities. In 2016, the United States Food and Drug Administration (FDA) removed three food contact substances (FCSs) containing perfluorinated chemicals from the list of approved FCSs due to concerns regarding chemical safety. To investigate the significance and limitations of the FDA's regulatory action for environmental health research, advocacy, and regulation, we conducted a media analysis and qualitative interviews with a range of involved stakeholders. We find that the FDA's regulatory action represents a potential shift from chemical-by-chemical regulation toward class-based regulation, where groups of chemicals can be identified as sharing properties and risks, and are thus evaluated and regulated together. The FDA decision sets an important precedent of using a petition process to delist chemicals based on a safety standard. However, the narrow reach of this action also highlights the need for more comprehensive, precautionary chemical regulation capable of thoroughly evaluating classes of chemicals, and raises important questions about how classes of chemicals are delimited in environmental health science and regulation.