EPA’s New Ozone Rule: Part 9

Exactly what was the EPA’s reasoning behind lowering the maximum ground-level ozone concentration from 75 ppb to 70 ppb? This is the opening paragraph of the discussion in EPA’s National Ambient Air Quality Standards for Ozone, 2011, page 35.

This section presents the rationale for the Administrator’s final decision that the O3 primary standard, which was set at a level of 0.075 ppm in the 2008 final rule, should instead be set at 0.070 ppm. In developing this rationale, the Administrator recognizes that the CAA [Clean Air Act — MHK] requires her to reach a public health policy judgment as to what standard would be requisite to protect public health with an adequate margin of safety, based on scientific evidence and technical assessments that have inherent uncertainties and limitations. This judgment requires making reasoned decisions as to what weight to place on various types of evidence and assessments, and on the related uncertainties and limitations. Thus, in selecting a final level, the Administrator is seeking not only to prevent O3 levels that have been demonstrated to be harmful but also to prevent lower O3 levels that may pose an unacceptable risk of harm, even if the risk is not precisely identified as to nature or degree.

What the EPA is saying is that it isn’t enough for the maximum concentration of ground-level ozone allowable to be set just below the minimum known to cause harm. Rather, the limit must be low enough so that even if the harm is not certain but only possible, the risk of harm is low enough to be acceptable. Question is, how low must the risk be to considered acceptable? The document itself states that risk must be taken into consideration even when it can’t be precisely identified. But does that mean that any level of risk, no matter how low, is unacceptable? That would be setting a very high standard indeed. And if that is not so, what is the maximum level of risk that is acceptable? What is the cutoff point?

Unspoken is the realization that it is politically unwise to try to impose tougher rules on the public than is necessary to achieve the objective. To do so is to impose unnecessary economic hardship that could provoke a backlash. And indeed, we saw that backlash in September 2011. The EPA can’t admit that fact, but it is nevertheless true.

There have been a number of controlled studies examining human exposure to ozone, but most have been at the 80 ppb level1. However, studies by William C. Adams, researcher (now retired) at the University of California at Davis did expose humans to ozone at average concentrations as low as 40 ppb2. Besides exposing his subjects to steady concentrations, Adams attempted to mimic the natural environment by slowly increasing and then decreasing the ozone concentration, much as the ambient ozone concentration grows in the morning, peaks in midday, and then declines toward evening. Adams found no statistically significant difference in lung function compared to breathing filtered (ozone-free) air at the 40 ppb and 60 ppb levels. However, a later analysis of Adam’s data by the EPA did find a small statistical difference at the 60 ppb level3. EPA finds this of concern, because a small statistical drop of lung function among healthy adults could manifest itself much more forcefully among those with lung disease4.

Still, most controlled studies on ozone exposure do not test beneath the 80 ppb level. Yet the EPA notes that there is no evidence that the harmful effects of ozone stop at the 80 ppb level (start with a very high concentration of ozone and slowly lower it. The concentration level where harmful effects would stop is known as the threshold). In fact, it can be inferred that such effects extend well below that level, because of the variability of responses of the test subjects5. I believe this means that if 80 ppb was the threshold level, then if you exposed test subjects to that concentration, you would see a number of small responses, but they would all be roughly equal to each other. If, on the other hand, some test subjects experience effects much more than others, even though the effects are still small, that indicates that the effects occur well below the 80 ppb level. And small effects for healthy people can mean big effects for those with respiratory disease.

The above concerned controlled studies of subjects of laboratory experiments. EPA also looked at epidemiological studies, studies of what is happening to populations in their day-to-day lives6. Some found thresholds between 25 and 50 ppb. Other studies never found a threshold because the damage that ozone inflicted seemed linear with the concentration. As I understand this, this means that if the concentration was reduced by a specific percentage (for example, a 20% reduction), measureable effects are reduced by the same percentage multiplied by fixed factor (say a 2% reduction in concentration results in a 3% decrease in effects, a 4% reduction results in a 6% decrease in effects, and so on). On the other hand, you might expect that at a concentration near the threshold level, a further reduction would result in a greater decrease of effects (say a 2% reduction results in a 3% in effects, but a 3% reduction results in a 25% decrease in effects, and a 4% reduction results in a 95% decrease in    effects)6. These studies never saw this sort of effect, so they could not conclude there was any threshold for ozone.

The EPA also looked at studies that did subset analysis looking only at days whose ozone concentration did not exceed certain ozone concentrations (such as 80 ppb and 61 ppb), and still found associations between those concentrations and lung function decrements)6.

Regarding the existence of a threshold for the effects of ozone, the EPA concluded:

Based on the above considerations, the 2007 Staff Paper recognized that the available evidence neither supports nor refutes the existence of effect thresholds at the population level for morbidity and mortality effects, and that if a population threshold level does exist, it would likely be well below the level of the then current standard and possibly within the range of background levels. Taken together, these considerations also support the conclusion that if a population threshold level does exist, it would likely be well below the level of the 0.075 ppm, 8-hour average, standard set in 2008.7

But if the EPA needed to pick the lowest allowable concentration, should it have chosen the lowest threshold found by the studies, 25 ppb? That would not be possible, because the background level of ground-level ozone (the concentration of ozone in the U.S. that is either naturally occurring or coming from outside the U.S. and over which the U.S. government has no control. The background level varies with location and season8.) is often above that level of 25 ppb9. This being the case, setting the standard at 25 ppb would have been an impossible demand. (In fact, the 2007 Staff Paper found that below 35 ppb, it was difficult to tell effects from ozone from effects from other air pollutants9.) Even 50 ppb would be an extremely difficult and expensive goal to meet.


  1. U.S. Environmental Protection Agency, National Ambient Air Quality Standards for Ozone, Final Preamble, 2011, p.38
  2. Adams,W.C., Comparison of chamber 6.6-h exposures to 0.04-0.08 ppm ozone via square-wave and triangular profiles on pulmonary responses Inhalation Toxicology vol. 18: pp. 127-136. For the abstract, click here.
  3. U.S. Environmental Protection Agency, National Ambient Air Quality Standards for Ozone, Final Preamble, 2011, p.38
  4. ibid.p.39
  5. ibid.p.40
  6. ibid.p.42
  7. ibid.p.43
  8. For a detailed discussion of background ozone levels, see U.S. Environmental Protection Agency, Integrated Science Assessment for Ozone and Related Photochemical Oxidants, Third External Review Draft, June 2012, Section 3.4, “Background Ozone Concentrations”, p.3-32ff.
  9. U.S. Environmental Protection Agency, National Ambient Air Quality Standards for Ozone, Final Preamble, 2011, p.42, p.107

One response to “EPA’s New Ozone Rule: Part 9

  1. Pingback: EPA’s New Ozone Rule: Part 24 | Michael Klein's Environmental Essays

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