Can We Teach Old Laws a New Risk? Federal Environmental Law, Risk Management Theory, and the Problem of Pharmaceutical and Personal Care Product Contamination of U.S. Water Supplies

Abstract

This Article is prompted by the discovery of endocrine disrupting compounds (EDCs) from pharmaceutical and personal care product (PPCP) chemicals generated by myriad unregulated sources in drinking water supplies and aquatic ecosystems throughout the United States. Exposure to EDCs and other chemicals from PPCPs can cause observable adverse impacts to aquatic flora and fauna, and while not yet conclusively established at current levels, a potentially wide range of adverse human health impacts, from birth defects to obesity. While proverbial canaries in the coal mine show worrying symptoms, PPCP contaminants remain largely unregulated as the U.S. Environmental Protection Agency (EPA) carries out risk assessment processes.

This Article summarizes the nature of this newly prioritized water contamination problem, current actions of the U.S. EPA, and the applicability of certain federal laws — the National Environmental Policy Act; Food, Drug, and Cosmetics Act; Safe Drinking Water Act; Clean Water Act; Resources Conservation and Recovery Act; Toxic Substance Control Act, and Pollution Prevention Act.

The Article then surveys risk management theory for guidance on whether, and if so how much, the PPCP problem should be addressed. These theories include market regulation, no-risk, precautionary principle, technology-based standards, risk-risk tradeoff, risk-benefit assessment, cost-effectiveness, regulatory budget, cost-benefit analysis, and sustainability.

Surveying these laws and risk management theories (1) provides practical foresight for how the PPCP problem would be addressed under federal law, and (2) uses a factually vexing public health and environmental problem as a case study for the appraisal of the laws and risk management theories themselves.

The Article concludes that cost-benefit analysis, the precautionary principle, and sustainability should be applied to guide policy-makers in an appropriately comprehensive fashion, yet the U.S. EPA and U.S. FDA currently apply risk assessment and risk-benefit approaches to the PPCP problem. The main operational requirements of these federal laws would probably not successfully protect against low-level, chronic, synergistic, and cumulative exposure to PPCPs without changes in regulatory initiative, breakthroughs in risk assessment, and new risk management approaches.

Keywords: pharmaceuticals, personal care products, drinking water, endocrine disruptor, environmental law, RCRA, SDWA, CWA, TSCA, human health, risk, uncertainty, precautionary principle, cost-benefit analysis