Role of science and judgment in setting national ambient air quality standards: how low is low enough?

The Clean Air Act (CAA) requires listing as criteria air pollutants those pollutants that arise from multiple sources and are found across the United States. The original list included carbon monoxide, nitrogen oxides, sulfur oxides, particulate matter, photochemical oxidants (later regulated as ozone), and hydrocarbons. Later, the listing of hydrocarbons was revoked and lead was listed. The CAA requires the EPA Administrator to set National Ambient Air Quality Standards (NAAQS) for these pollutants using the “latest scientific knowledge” at levels that, in the judgment of the Administrator, are “requisite to protect public health” while “allowing an adequate margin of safety” without considering the cost of implementing the NAAQS. The NAAQS are set using scientific knowledge to inform the Administrator’s policy judgments on each NAAQS. Recently, there has been increasing tension and debate over the role of scientific knowledge versus policy judgment in the setting of NAAQS. This paper reviews key elements of this debate drawing on the opinion of Supreme Court Justice Stephen Breyer, in Whitman v. American Trucking Associations, to resolve the conundrum posed by the CAA language. I conclude that scientists should carefully distinguish between their interpretations of scientific knowledge on specific pollutants and their personal preferences as to a given policy outcome (i.e., specific level and form of the NAAQS), recognizing that these are policy judgments as to acceptable levels of risk if the science does not identify a threshold level below which there are no identifiable health risks. These policy judgments are exclusively delegated by the CAA to the EPA Administrator who needs to articulate the basis for their policy judgments on the level and form of the NAAQS and associated level of acceptable risk

Linear low-dose extrapolation for noncancer health effects is the exception, not the rule

The nature of the exposure-response relationship has a profound influence on risk analyses. Several arguments have been proffered as to why all exposure-response relationships for both cancer and noncarcinogenic end-points should be assumed to be linear at low doses. We focused on three arguments that have been put forth for noncarcinogens. First, the general “additivity-to-background” argument proposes that if an agent enhances an already existing disease-causing process, then even small exposures increase disease incidence in a linear manner. This only holds if it is related to a specific mode of action that has nonuniversal properties—properties that would not be expected for most noncancer effects. Second, the “heterogeneity in the population” argument states that variations in sensitivity among members ofthe target population tend to “flatten out and linearize” the exposure-response curve, but this actually only tends to broaden, not linearize, the dose-response relationship. Third, it has been argued that a review of epidemiological evidence shows linear or no-threshold effects at low exposures in humans, despite nonlinear exposure-response in the experimental dose range in animal testing for similar endpoints. It is more likely that this is attributable to exposure measurement error rather than a true non-threshold association. Assuming that every chemical is toxic at high exposures and linear at low exposures does not comport to modern-day scientific knowledge of biology. There is no compelling evidence-based justification for a general low-exposure linearity; rather, case-specific mechanistic arguments are needed

Micromechanical Properties of Injection-Molded Starch–Wood Particle Composites

The micromechanical properties of injection molded starch–wood particle composites were investigated as a function of particle content and humidity conditions. The composite materials were characterized by scanning electron microscopy and X-ray diffraction methods. The microhardness of the composites was shown to increase notably with the concentration of the wood particles. In addition,creep behavior under the indenter and temperature dependence were evaluated in terms of the independent contribution of the starch matrix and the wood microparticles to the hardness value. The influence of drying time on the density and weight uptake of the injection-molded composites was highlighted. The results revealed the role of the mechanism of water evaporation, showing that the dependence of water uptake and temperature was greater for the starch–wood composites than for the pure starch sample. Experiments performed during the drying process at 70°C indicated that the wood in the starch composites did not prevent water loss from the samples.Peer reviewe

Creating a strategy for science-based national policy: Addressing conflicting views on the health risk of low-level ionizing radiation. Final report, Wingspread Conference

Significant cancer risk for adults exposed to more than 100 millisieverts (10 REM) of ionizing radiation. More research on low-level ionizing radiation is needed in molecular and cellular mechanisms of injury and ongoing exposed populations. Implementation costs should be considered in regulating low-level ionizing radiation. Comparative risk assessment is a powerful tool for risk-based policy formation, and conflicting legal statutes should become harmonized for radiation regulation. More public dialog on low-level radiation is needed. A high level commission should evaluate radiation hazard control practices