Comments on EPA Ozone Regulations by S. Stanley Young, PhD, FASA, FAAAS

Three points. Data access. There is no effect of air quality on mortality in western US.

There are geographic, and other inconsistencies that call into question regulatory reliance

on current data and methods. In summary of the three points given below, the EPA is

seeking to impose a “one size fits all” regulation that will not improve health in well over

one half of the country (all of the US west of Chicago) while costing enormous sums of

money that, since the US Treasury is running a deficit, we do not in fact have.

Point 1: Data Access

There is no public access to most the data sets in the papers that the EPA is relying on. As

the EPA does not have most of the data either, the EPA is relying on “Trust Me” science,

which is to say, not science at all.

Board on Life Sciences, Sharing Publication-Related Data and Materials:

Responsibilities of Authorship in the Life Sciences (National Academies Press,

Washington, DC, 2003)

see www.nap.edu/books/0309088593/html/

Community standards for sharing publication-related data and materials should flow from

the general principle that the publication of scientific information is intended to move

science forward. More specifically, the act of publishing is a quid pro quo in which

authors receive credit and acknowledgment in exchange for disclosure of their scientific

findings. An author’s obligation is not only to release data and materials to enable others

to verify or replicate published findings (as journals already implicitly or explicitly

require) but also to provide them in a form on which other scientists can build with

further research. All members of the scientific community—whether working in

academia, government, or a commercial enterprise—have equal responsibility for

upholding community standards as participants in the publication system, and all should

be equally able to derive benefits from it.

Roger D. Peng, Francesca Dominici, and Scott L. Zeger Reproducible epidemiologic

research Am. J. Epidemiol. (1 May 2006) 163 (9): 783-789.

http://aje.oxfordjournals.org/content/163/9/783

The replication of important findings by multiple independent investigators is

fundamental to the accumulation of scientific evidence. Researchers in the biologic and

physical sciences expect results to be replicated by independent data, analytical methods,

laboratories, and instruments. Epidemiologic studies are commonly used to quantify

small health effects of important, but subtle, risk factors, and replication is of critical

importance where results can inform substantial policy decisions. However, because of

the time, expense, and opportunism of many current epidemiologic studies, it is often

impossible to fully replicate their findings. An attainable minimum standard is

‘‘reproducibility,’’ which calls for data sets and software to be made available for

verifying published findings and conducting alternative analyses. The authors outline astandard for reproducibility and evaluate the reproducibility of current epidemiologic

research. They also propose methods for reproducible research and implement them by

use of a case study in air pollution and health.

Point 2: There is no effect of air quality on mortality in western US.

Using a data set from Pope et al. (2009) and dividing the data geographically, there was

no effect of PM2.5 on mortality in the western US. When the data set is divided at

Chicago, there is a very small effect in the eastern US and no effect in the West. It is

improper to impose a one size fits all across the US when any effects are localized. In

statistical terms, there is a “geography by air quality interaction” so it is not proper to rely

on average effects. No effect is observed in western US by multiple research groups

using multiple data sets, e.g. Smith et al. 2009 below.

Pope CA III, Ezzati E, Dockery DW. 2009. Fine-particulate air pollution and life

expectancy in the United States. N Engl J Med 360 :376-86.

Point 3. Geographic, and other inconsistencies

“In summary, it is our view that estimates of the association between ozone and

mortality, based on time-series epidemiologic analyses of daily data from multiple cities,

reveal important still-unexplained inconsistencies and show sensitivity to modeling

choices and data selection. These inconsistencies and sensitivities contribute to serious

uncertainties when epidemiological results are used to discern the nature and magnitude

of possible ozone-mortality relationships or are applied to risk assessment.”

Richard L. Smith, Baowei Xu, and Paul Switzer. Reassessing the relationship between

ozone and short-term mortality in U.S. urban communities. Inhalation Toxicology, 2009;

29(S2): 37–61.