The Perils and Promise of the 2016 Lautenberg Chemical Safety Act: A Critical Appraisal of the U.S. Experience

Abstract

In the U.S., people are exposed to multiple industrial chemicals, many of them known to cause adverse health effects (e.g. asbestos, methylene chloride). Further, 8,700 high production volume chemicals are largely untested for health effects. Many chemicals are not tested or regulated because of flaws in the law that governs chemicals in the U.S.—the 1976 Toxic Substances Control Act. In 2016, amendments called the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg TSCA) were finalized to address these gaps and directed the US Environmental Protection Agency (USEPA) to evaluate chemicals under enforceable deadlines against risk-based safety standards that account for susceptible subpopulations and with new powers to compel manufacturers to test products for safety. However, many scientific decisions are left to USEPA during implementation, including how to evaluate human and animal scientific evidence, define susceptibility and aggregate risk, incorporate new science into risk assessment, define conditions of use, and determine what constitutes an unreasonable risk. Actions by USEPA may preempt individual states from taking any further action on regulated chemicals. Implementation can either lead to public health protections or worsening of the deficits that have hampered U.S. chemical policy for the past 40 years. Effective public health protection requires strong implementation of Lautenberg TSCA, in which USEPA evaluates, assesses and limits exposures to multitudes of harmful chemicals, and corporations provide adequate evidence to evaluate hazards. This presentation will briefly introduce data needs and ways to improve the scientific basis, transparency and protection of vulnerable populations in chemical assessments under the new law. The role for epidemiologic studies and biomonitoring data from pregnant women will be featured. We recommend principles geared towards ensuring U.S. chemical policy that is truly public health protective.