EXCLUSIVE: The Environmental Protection Agency is exaggerating the  potential health benefits—especially for children—it says result from a new rule that will set sharply lower ozone levels across the U.S., according to a detailed study of the EPA model. The study  concludes many of the supposed benefits may already exist under current EPA standards.

The ozone rule, slated for publication in October is billed by its critics as the most expensive regulatory change in American history. Estimates of the cost of compliance, for industries and all levels of government, run as high as $1.1 trillion, and the negative impact on  U.S. Gross Domestic Product is estimated to run even higher.

The current U.S. ozone standard, set in 2008, allows a maximum 75 parts per billion (ppb) of “ground-level ozone” —down from 84ppb in 1997-- and is still being implemented. The new standard being considered by the Obama Administration’s EPA is likely to fall between 70 and 65 ppb, though levels as low as 60 are being examined—as well as the current standard.

The expert study was submitted to EPA by members of a Washington-based organization named NERA Economic Consulting during a three-month comment period after the proposed ozone rule change  was announced last December. According to the federal government’s regulations.gov website, the ozone rule change has drawn some 437,000 comments of varying sophistication from a broad array of Americans, ranging from ordinary citizens to environmental activists to state and local officials and industrial associations.

In response to a question from Fox News, an EPA spokesperson declared that “we are currently in the process of reviewing those comments to prepare a draft final rule. The response to comment document will be [made] available” at the same regulations.gov site only “after the final rule is signed.”  The finalized rule is slated to appear on October 1 in the Federal Register.

The NERA comment study may be lost among hundreds of thousands of others on the federal government’s website, but it stands out sharply in other ways—notably by analyzing EPA’s methods on their own terms. Among other things, it indicates that:

  • Due to a lack of data on ozone exposure for children aged 5 to 17 in the main clinical studies that it used for  its calculations, EPA  simply extended the clinical results for 18-year-olds to the younger group—even though other clinical studies  indicate children have a “reduced responsiveness”—that is, less of a reaction—to ozone compared with adults. (EPA itself admits in a key supporting document known as its Health Risk  and Exposure Assessment, or HREA, for ozone, that there are “uncertainties” in their extrapolation that “could be substantial.”)
  • EPA failed to model  information from  the same clinical studies that showed increased body weight  can  produce “substantial” changes in ozone’s negative effects on lung capacity. This also had implications for  children: a 15 percent to 21 percent drop in the percentage of children who the EPA says risk temporary loss of lung capacity at the current 75 ppb ozone standard.
  • That source of “model uncertainty” alone reduces the estimate of risk to children under the current ozone standard TO THE SAME LEVEL that EPA claims will come to children if it tightened the current ozone limit down to 70 ppb.
  • EPA also did not publish information about the degree of statistical uncertainty involved in the clinical studies it used for its calculations of health impact. In part, EPA said that it could not model some of the uncertainty because all of the necessary clinical data  “are not available to EPA.”

The NERA experts, however, declared that the data EPA said it lacked was not necessary to test the uncertainty of  its lung function risk estimates. Instead, they obtained  relevant information they called “standard output”  from the researchers who produced the initial statistical analysis of the clinical data and ran hundreds of simulations using EPA’s own model. They again found that “the anticipated health benefits of moving to 70 ppb presented” by EPA  for the 5 to 17 age group “may already have been realized at 75 ppb.”

  • In other words, through lack of consideration for the uncertainty in its modelling efforts, EPA may be touting benefits from tighter ozone standards that “may be non-existent for some age groups.”

The gaps and selective choices in EPA’s justification for tougher standards examined  by the experts in their dense, technical study  are especially important because EPA’s arguments for change in the standard have emphasized increasing health protection  for children, asthma sufferers and older adults who are said to be more susceptible to the effects of ozone, a pervasive but toxic version of oxygen naturally present in low dosages in all breathable air.

In the upper atmosphere, ozone helps to protect the Earth from ultra-violet radiation—and at ground level  is naturally generated through the effect of sunlight on organic compounds, as well as being  industrially produced in larger quantities that can be harmful, though often temporarily, to lung tissue.

EPA’s ozone standards are intended to be applied nation-wide, though its HREA document focuses on levels in 15 major U.S. urban areas.

The dense technical study by the NERA experts also offers a small window into the arcane and often murky world of statistical modelling for government policymakers, where physical evidence backing scientific generalizations can be sparse, linkages of that evidence to larger and more diverse populations and situations involves blindingly complicated and selective  calculations--and where truth is not a fact but usually an assembly of degrees of probability and uncertainty.

In  the case of EPA’s ozone health benefit calculations, , says  Anne Smith, Senior Vice-President of Washington-based NERA Economic Consulting and co-author of the study critical of EPA’s methods,  “there is an enormous amount of uncertainty,” which the agency has done little to expose, which reflects an an overall lack of scientific evidence at the low ozone levels that drive the risk estimates.”

EPA’s methods in failing to clarify some of the statistical uncertainties in its ozone rationale also “are quite out of line with standard procedure in other EPA assessments,” Smith told Fox News.

Those uncertainties are “important because [the] estimates are based on a statistical model of very noisy (i.e. highly variable) data from small samples of individuals who participated in a few clinical studies,” as the NERA study puts it. One study, for example, involved only 60 individuals riding bicycles for 6 ½ hours at a stretch while breathing air spiked with varying amounts of ozone—the alleged equivalent of heavy outdoor labor.

Said  Smith’s co-author, Garrett Glasgow, a NERA Senior Consultant and specialist in quantitative methodology:  “We just don’t really understand how ozone affects children.”

The NERA study was funded by the American Petroleum Institute, a fact that is bound to draw criticism from environmental activists. Fox News consulted other prominent experts in the field, however, who agreed with the thrust of the document.

The NERA study “makes a good start in analyzing the problems with EPA’s analysis methods,” observed Tony Cox,  chief sciences officer at NextHealth Technologies, a data analytics firm. Cox  recently testified before two House subcommittees on the EPA ozone rule and called the agency’s predictions of public health benefits “exaggerated and unwarranted.”

“EPA makes clear that its conclusions rest on assumptions that are convenient but not accurate,” Cox told Fox News. “They have not quantified the uncertainties involved. What the [NERA experts] have done is begin answering that question.”

If anything, he added, “one might be led to a much stronger conclusion than they did. They have started to do something that EPA says it does, but doesn’t.”

The NERA study was also endorsed as “a very nice piece of work” by Roger McClellan, an expert on inhalation toxicology and human health risk analysis issues related to air quality. McClellan has also served in the past on numerous panels of EPA’s Clean Air Scientific Advisory Committee, or CASAC, and chaired CASAC itself for four years.

“EPA is trying to extrapolate adult clinical test results involving ozone to populations with asthma, and younger populations,” McClellan said. “I don’t think there is wide agreement today that ozone causes asthma, though it does trigger asthmatic attacks. We have to be mindful that the respiration in these tests is probably greater than on most playgrounds.” McClellan also underlined that whatever the true impact of ozone, “these are reversible—temporary—effects.”

“To me, there is no scientific rationale that this particular rule is the right, science-based decision. Like so many things in the environmental area, this is tied up with emotion.”

George Russell is editor-at-large of Fox News and can be found on Twitter:  @GeorgeRussell  or on Facebook.com/George Russell