title: A review and critique of the EPA's rationale for a fine particle standard.
abstract: I review the rationale for the Environmental Protection Agency's 1996 fine particle standard, which was based almost entirely on the epidemiological data with neither support from Toxicology nor understanding of mechanism. While many epidemiological papers available in 1996 reported associations between ambient particles and adverse effects on human health, many others did not and the evidence fell far short of supporting a causal association between particle mass concentration and human health. The literature appearing after 1996 further complicates the picture. The large studies that have appeared after 1996, such as National Mortality Morbidity and Air Pollution Study, and the reanalyses of the American Cancer Society II study, report risks that are substantially smaller than the risks reported in the 1996 Criteria Document and Staff Paper. Moreover, concerns about confounding by weather, temporal trends and co-pollutants remain unresolved. Other issues having to do with model choice have resurfaced as a result of reanalyses of critical data to address a glitch in a widely used software package for time-series epidemiology studies of air pollution. Finally, contemporary examples show that the results of observational epidemiology studies can be seriously biased, particularly when estimated risks are small, as is the case with studies of air pollution. The Agency has largely ignored these issues. I conclude that a particle mass standard is not defensible on the basis of a causal association between ambient particle mass and adverse effects on human health. Such a standard may be justifiable on the basis of the precautionary principle, however. The Agency could argue that the Science raises concerns about current levels of air pollution, and that reduction of ambient fine particulate matter mass, if it could be achieved without an increase in the level of the ultrafines, could have positive effects on human health. If the Agency justifies a particulate matter mass standard on these grounds then the debate over the form and level of the standard will, for all practical purposes, belong strictly in the Policy arena.
authors.affiliation: Sciences International, Inc., King Street Station, 1800 Diagonal Road, Suite 500, Alexandria, VA 22314, USA. Moolgavkar@earthlink.net
authors.forename: Suresh H
authors.initials: SH
authors.lastname: Moolgavkar
mesh_terms: D000397:Air Pollution / Q000009:adverse effects / Q000032:analysis; D005069:Evaluation Studies as Topic; D006801:Humans; D010316:Particle Size; D014481:United States / Q000453:epidemiology; D014484:United States Environmental Protection Agency / Q000331:legislation & jurisprudence / Q000592:standards*