In October 2015, the United States Environmental Protection Agency (EPA) lowered the level of the ozone National Ambient Air Quality Standard (NAAQS) from 0.075 ppm to 0.070 ppm (annual 4th highest daily maximum 8-h concentration, averaged over three years). The EPA estimated a 2025 annual national non-California net benefit of $1.5 to $4.5 billion (2011$, 7% discount rate) for a 0.070 ppm standard, and a −$1.0 to $14 billion net benefit for an alternative 0.065 ppm standard. The purpose of this work is to present a combined toxicological and economic assessment of the EPA’s benefit-cost analysis of the 2015 ozone NAAQS. Assessing the quality of the epidemiology studies based on considerations of bias, confounding, chance, integration of evidence, and application of the studies for future population risk estimates, we derived several alternative benefits estimates. We also considered the strengths and weaknesses of the EPA’s cost estimates (e.g., marginal abatement costs), as well as estimates completed by other authors, and provided our own alternative cost estimate. Based on our alternative benefits and cost calculations, we estimated an alternative net benefit of between −$0.3 and $1.8 billion for a 0.070 ppm standard (2011 $, 7% discount rate) and between −$23 and −$17 billion for a 0.065 ppm standard. This work demonstrates that alternative reasonable assumptions can generate very difference cost and benefits estimates that may impact how policy makers view the outcomes of a major rule.

An inhalation reference concentration (RfC) was developed for diethanolamine (DEA), based principally on evaluation of three animal studies (Gamer et al., 1993, 1996, 2008). The RfC (25 μg/m3) was based on statistically significantly increased relative liver weight in female rats in Gamer et al. (2008) as the critical effect. The lower confidence limit on the benchmark dose (BMDL10 of 5.5 mg/m3) was adjusted to a human equivalent concentration and to continuous exposure before dividing the final point of departure (2.3 mg/m3) by a total factor of 90 that considered standard key areas of uncertainty (intrahuman variability, potential interspecies toxicodynamic differences, database limitations). While laryngeal effects observed in Gamer et al. (2008) were also considered as candidate critical effects, evaluation of the adversity and human relevance of rat laryngeal squamous metaplasia and concomitant effects at the various exposure levels resulted in identifying a LOAEL for laryngeal squamous hyperplasia and chronic inflammation that was much higher than the liver weight LOAEL identified. The RfC of 25 μg/m3 is considered health protective for the general population and can be used to evaluate the potential health effects of long-term environmental exposure of the general public (i.e., long-term, ambient air dispersion modelling or monitoring data).