A science-based agenda for health-protective chemical assessments and decisions: overview and consensus statement

Tracey J. Woodruff*, Swati D. G. Rayasam, Daniel A. Axelrad, Patricia D. Koman, Nicholas Chartres, Deborah H. Bennett, Linda S. Birnbaum, Phil Brown, Courtney C. Carignan, Courtney Cooper, Carl F. Cranor, Miriam L. Diamond, Shari Franjevic, Eve C. Gartner, Dale Hattis, Russ Hauser, Wendy Heiger‑Bernays, Rashmi Joglekar, Juleen Lam, Jonathan I. Levy, Patrick M. MacRoy, Maricel V. Maffini, Emily C. Marquez, Rachel Morello‑Frosch, Keeve E. Nachman, Greylin H. Nielsen, Catherine Oksas, Dimitri Panagopoulos Abrahamsson, Heather B. Patisaul, Sharyle Patton, Joshua F. Robinson, Kathryn M. Rodgers, Mark S. Rossi, Ruthann A. Rudel, Jennifer B. Sass, Sheela Sathyanarayana, Ted Schettler, Rachel M. Shaffer, Bhavna Shamasunder, Peggy M. Shepard, Kristin Shrader‑Frechette, Gina M. Solomon, Wilma A. Subra, Laura N. Vandenberg, Julia R. Varshavsky, Roberta F. White, Ken Zarker and Lauren Zeise

The manufacture and production of industrial chemicals continues to increase, with hundreds of thousands of chemicals and chemical mixtures used worldwide, leading to widespread population exposures and resultant health impacts. Low-wealth communities and communities of color often bear disproportionate burdens of exposure and impact; all compounded by regulatory delays to the detriment of public health. Multiple authoritative bodies and scientific consensus groups have called for actions to prevent harmful exposures via improved policy approaches. We worked across multiple disciplines to develop consensus recommendations for health-protective, scientific approaches to reduce harmful chemical exposures, which can be applied to current US policies governing industrial chemicals and environmental pollutants. This consensus identifies five principles and scientific recommendations for improving how agencies like the US Environmental Protection Agency (EPA) approach and conduct hazard and risk assessment and risk management analyses: (1) the financial burden of data generation for any given chemical on (or to be introduced to) the market should be on the chemical producers that benefit from their production and use; (2) lack of data does not equate to lack of hazard, exposure, or risk; (3) populations at greater risk, including those that are more susceptible or more highly exposed, must be better identified and protected to account for their real-world risks; (4) hazard and risk assessments should not assume existence of a “safe” or “no-risk” level of chemical exposure in the diverse general population; and (5) hazard and risk assessments must evaluate and account for financial conflicts of interest in the body of evidence. While many of these recommendations focus specifically on the EPA, they are general principles for environmental health that could be adopted by any agency or entity engaged in exposure, hazard, and risk assessment. We also detail recommendations for four priority areas in companion papers (exposure assessment methods, human variability assessment, methods for quantifying non-cancer health outcomes, and a framework for defining chemical classes). These recommendations constitute key steps for improved evidence-based environmental health decision-making and public health protection.