EPA Makes Mistakes in Proposed Air Quality Standards

Published December 1, 2006

Over the past three decades, the U.S. Environmental Protection Agency (EPA) has repeatedly ratcheted up restrictions and regulatory burdens to regulate ever-decreasing air pollutant emissions, often with no discernable effect on human health. This process is continuing with EPA’s proposed 2006 ambient air standards.

In doing so, EPA has repeatedly violated scientific rules regarding epidemiology and toxicology–a scandal that must not be ignored. Studies of the health effects of air pollution relied on by EPA to enact increasingly strict air emissions controls–such as the Dockery 1993, Pope 1995, and Samet 2000 studies (see references at end of this story)–have all failed to demonstrate health risks of any significance.

There is certainly no air pollution health “crisis” in the United States today. Even the worst levels of outdoor air pollution in America don’t reach a toxic level.

This reveals the major flaw in EPA’s crisis rhetoric: Junk science toxicology that completely sidesteps any effort to define toxin or toxicity.

Rules of Causation

The Bradford Hill (BH) criteria for establishing scientific rules of causation are essential in showing toxic effects. They require the toxicologist to establish plausibility, dose effect, reproducibility, time relationship, and a pattern of predictable and observable effects.

EPA is required by common sense and federal statute to apply the BH criteria in air pollution studies and all other toxicology work. Instead, EPA cites small changes of toxicity within insignificant ranges of effect as the reason it must act to reduce emissions and “save lives.”

EPA Procedural Flaws

The main epidemiological and toxicological flaws of the EPA health effects studies and recent policymaking are as follows:

1. The Dockery 1993 and Pope 1995 studies did not show valid evidence of death effects, since they showed a death effects relative risk below 1.1, a negligible relative risk that is 10 percent of the minimum relative risk all epidemiologists consider necessary for proof of causation. A 200 percent or 300 percent change in death effect is generally regarded as the lower limit to establish causality. There is a greater relative risk of whole milk causing lung cancer than the relative risk EPA has shown for air pollution.

2. This relative risk problem cannot be overcome by EPA and health effects researchers emphasizing the misleading use of the term statistical significance, which is not a proof test. A finding can be statistically significant and reliable but absolutely wrong.

3. The health effects research used by EPA has consistently ignored the concept of threshold for toxicity. Toxicology science recognizes the idea of threshold of effect and the maxim that the dose makes the toxin. EPA consistently ignores this principle in projecting exceedingly small doses as having a potentially toxic effect.

4. The studies cited by EPA fail to show actual causality or even epidemiological proof, but instead rely on “associations” between various diseases and bad air (in historical instances, no less, not contemporary America). Associations are not proof, however. They are simply observations of clusters of events that may or may not mean something and are subject to the influence of confounding factors. For example, ice cream consumption and drowning or boating accidents are associated by season, but ice cream eating doesn’t cause water accidents.

5. The “precautionary principle” used by EPA as stand-alone policy justification is nothing more than a dressed-up version of anxiety, cannot pass muster for admissible scientific evidence in federal court, and fails to include risk/benefit analysis.

6. EPA has a mandate to act only on the basis of acceptable scientific evidence of health effects, and is obligated to avoid speculative “precautionary principle” approaches to regulatory policy.

7. Under no valid scientific analysis can EPA use the methodologies or the results of its “supporting” studies to justify more burdensome air pollution regulations. In fact, there is strong evidence for rescinding the last round of National Ambient Air Quality Standards.

8. Nonetheless, EPA and its health effects researchers have made public announcements proclaiming that thousands are dying in America due to air pollution, when the studies do not show any proof of death effect at all.

9. Based on the information reviewed in this critique, it is clear EPA should revisit its old regulations; forgo new, more onerous, and more expensive regulatory interventions; and suspend its rulemaking regarding air pollution until it can find valid and reliable science on health effects.

Victory Over Air Pollution

Toxic air pollution existed in the past and still may occasionally occur in some places on the planet as a local phenomenon, as particulate and other noxious air pollution in industrial areas, from various sources. However, trends in U.S. air pollution in the past 30 years, as reported and confirmed by EPA, have all been positive and are attributable to changes in industrial processes, regulatory efforts, and cleaner use of petroleum and coal.

People today do not go out into the streets of America, and then choke and die. The days of the people of London and Pittsburgh wearing dark clothes to mask the effect of soot and smoke are long gone. Any study or discussion of air pollution is focused on a moving, improving problem.

The death and illness rates during smog and air pollution catastrophe periods in the past were also affected by less-effective medical management and heavier cigarette smoking. In addition, airway diseases, the main deleterious health effect of any air pollution, were less treatable before the 1970s, and pulmonary medicine has changed dramatically for the better since then.

EPA Ignoring Truth

While much of the public today wrongly believes the air is worse than ever and that there is an air pollution health effects crisis, that misapprehension is the fault of EPA and the mass media, who love to scare the public, since the budgets of EPA and environmental organizations depend on public anxiety over the matter.

Telling the truth that there is no crisis of air pollution means no publications for air pollution researchers, no invitations to swell events, no funding, and no chance to pursue a political agenda.

Policy Challenges

EPA is charged with responsible health effects research and policymaking. It must therefore answer several important questions:

1. Why does EPA allow relative risk below acceptable levels of proof to influence policy?

2. If health studies don’t eliminate confounding factors, does EPA have the authority to impose an onerous regulatory regime on the American people on the theory that cleaner air is a worthwhile goal even if it doesn’t have any effect on health?

3. Considering that EPA regulatory activity is a tremendous burden to the economy, that air regulations have a cost effect measured in billions of dollars per year, and that economic factors are an undeniable influence on quality of life and life expectancy, can the pursuit of some abstract ideal of pure air be justified despite its negative effects on people’s lives?

The uncertainties of the air pollution health effects studies, the weak relative risks cited, and the methodological problems of the most influential of the studies are so obvious that EPA clearly should reassess what has gone wrong in air pollution health effects research and how these weak studies have affected its policies and rulemaking.

EPA doesn’t have the right to panic the public and political leaders with deceptive junk science in the service of fanatical environmentalism.

John Dale Dunn, M.D., J.D. ([email protected]) lives in Lake Brownwood, Texas.

Studies Debunked

Dockery, D.W., Pope, C.A. 3d, Xu X., et al., “An association between air pollution and mortality in six U.S. cities,” New England Journal of Medicine, 1993; 329:1753-9.

Pope, C.A., Thun, M.J., Manboodiri, M.M., et al., “Particulate air pollution as a predictor of mortality in a prospective study of U.S. adults,” American Journal of Respiratory and Critical Care Medicine, 1995; 151: 669-74.

McDonnell, W.F., Nishino-Ishikawa, N., Petersen, F.F., et al., “Relationship of mortality with the fine and coarse fractions of long-term ambient PM10 concentrations in non-smokers,” Journal of Experimental Environmental Epidemiology, 2000; 10: 427-436.

For more information …

Dunn, J.D., “More on EPA and Air Pollution: Junk Science and Legal Precedents,” American Council on Science and Health, January 3, 2005, http://www.acsh.org/factsfears/newsID.483/news_detail.asp

Hill, A.B., “The Environment and Disease: Association or Causation?” Proceedings of the Royal Society of Medicine, 58 (1965), 295-300, http://www.edwardtufte.com/tufte/hill