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"Final" Staff Paper draft. This is not only because the calculations are made for only those <br />people living in 12 MSAs, but also because it ignores the people living outside of all of the <br />MSAs in the U.S. The fact that ozone is regional in nature, and is often higher in <br />concentration downwind of MSAs than within them, has not been considered in the risk <br />assessment. <br />2) Another, perhaps related, deficiency in this chapter is the lack of any summary section <br />on "margin of safety", a factor that is supposed to be explicitly considered in setting a <br />NAAQS. This is an issue that is an especially troubling one for ozone, where the Staff Paper <br />acknowledges that health effects that it judges to be adverse are expected to occur in large <br />numbers of people living in the 12 MSAs who are considered to be susceptible, at least for <br />the 74/4 and 70/4 options. <br />3) The section on Margin of Safety in the Agency's NAAQS proposal should also <br />address the fact that the clinical laboratory exposures of healthy human volunteers provided <br />much of the quantitative exposure-response information that guided the selection of the <br />NAAQS options that were presented in the Jan. 2007 final draft, involved exposure to ozone <br />alone. <br />4) While ozone is an appropriate indicator species for the Ozone and Photochemical <br />NAAQS, it must be remembered that there is evidence, cited in the Staff Paper, from the <br />childrens' camp studies and studies of workers and adults engaged in recreational exercise <br />outdoors, that the ambient air mixtures produce greater responses than those seen in the <br />studies of children and healthy adults in chambers with exposures to ozone alone. Thus, the <br />chamber responses are likely to provide underestimates of the responses to ozone in ambient <br />air mixtures. <br />5) For the reasons summarized above, I consider the effects that are estimated for the <br />74/4 level to be too high for a NAAQS that provides an acceptable degree of public health <br />protection. I recognize that any limit lower than 70/4 is not technologically feasible for the <br />U.S. in the near future, and that the costs of implementation for a still lower limit would <br />likely exceed the public health benefits. <br />6) I believe that the issues that are raised above that deal with the adequacy of the <br />protection that can be provided by the alternate NAAQS levels and the extent of a Margin of <br />Safety, if any, at these levels, should be more thoroughly and explicitly addressed in the <br />Federal Register proposal for a revised Ozone NAAQS than they were in the Final Draft of <br />the Ozone Staff Paper. <br />~_ "'' ~` <br />C-20 <br />