Our Toxics Regulatory System and Why Risk Assessment Does Not Work: Endocrine Disrupting Chemicals as a Case in Point

Our current toxics regulatory system is based on the fundamental premise that the public expects a high degree of safety -- close to absolute safety -- in the regulation of toxins in our environment. To implement a system based on this fundamental assumption, we assume further that we can use risk assessment to develop "health-based" safety standards and use command and control regulation to implement them. This Article suggests that the fundamental premise that we can and should develop and apply standards that ensure safety to human health in our toxics regulatory schemes5 has little basis in current political and scientific reality. Politically, human safety is not the true goal of toxics regulation, and scientifically, human safety is not an achievable goal. Rather, politicians obfuscate the true regulatory goal-to regulate toxins so that they present politically acceptable risk-by using terminology and standards that imply safety. Even if safety were the true goal of toxics regulation, the creation of safety-based standards to regulate toxins is not a particularly practical goal. This Article asserts that, at least as to chemicals that disrupt the human endocrine system-chemicals that have the potential for grave harm to humans-it is not currently feasible to determine safe exposure levels in the complex and interrelated world in which we live. Second, even if we could determine such levels, we would still face the enormously difficult task of ensuring compliance with these predetermined "safe" exposure levels. This article specifically highlights the inherent problems with quantitative risk assessment in toxics regulation, as it has been applied to toxic chemicals in general and will likely be applied to endocrine disrupting chemicals. The article ultimately suggests that political and societal honesty is needed in the future regulation of toxic chemicals. Our normative position must be to admit publicly that toxies regulation is not designed to ensure safety to human health, but to regulate toxins so that they present a level of risk that is acceptable to the public. Rather, our goal has been to regulate and manage the risk of toxins so that they present "politically acceptable risk." If this regulatory goal were more transparent, the public could realistically assess the current regulatory paradigm, and consider alternatives. I thus suggest a fundamental shift in the philosophy of toxics regulation. Our society must have an open discussion about the dangers of synthetic chemicals and must move toward reducing our overall use and discharge of these chemicals-particularly those suspected of disrupting our endocrine systems. This shift in thinking would force chemical manufacturers to initiate voluntary screening of existing and new chemicals before they are produced and marketed for use and to reduce the overall discharge of chemicals suspected of endocrine disruption. Barring such voluntary action by the chemical industry, the government must make screening for endocrine effects mandatory for new chemicals and must require manufacturers to begin screening existing chemicals for endocrine effects.