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## Texas Commission on Environmental Quality (TCEQ) Written Comments to the Science Advisory Board (SAB) Ozone Review Panel for the March 23, 2011 Teleconference
Michael Honeycutt, Ph.D. Division Director, Toxicology Division Texas Commission on Environmental Quality Austin TX, 78726 Telephone: 512

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- mail: Michael.honeycutt@ tceq.texas .gov March 14, 2011 Holly Stallworth, Ph.D. Economist and Designated Federal Officer Clean Air Sc ientific Advisory Committee (CASAC) Environmental Protection Agency, Mail Code 1400R 1300 Pennsylvania Ave., NW, Washington D.C. 20004 Phone: 202

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- 2073 stallworth.holly@epa.gov
Dear Ozone Review Panel Members: I, Dr. Michael Honeycutt, Director of the Toxicology Division of the Texas Commission on Environmental Quality , would like to offer the following written comments on behalf of the TCEQ

. The Federal Register Notice for the March 23 , 2011 Teleconference of the Clean Air Scientific Advisory Commi ttee Ozone Review Panel indicated that members of the public could provide written comments. I have previously provided Oral comments to the panel on February 18, 2011.

The current proposed standard is based primarily on ecological epidemiology studies. Ecological epidemiology studies are designed as hypothesis

- generating studies and are not scientifically

- rigorous enough to base such an important policy decision. Meta analyses of ecological epidemiology studies may give the appearance of ha rd data, but they have an extremely poor exposure component and studies conducted to date s h ow only slight associations. Even a well

- conducted e pidemiology study is a blunt instrument at best and not adequate to establish whether or not 75 ppb ozone is an y less health protective than 65 ppb

. When developing strategies to address ambient ozone, every ppb2

reduction in the standard results in more emission reductions needed

. If the standard is to be lowered, the scientific data must clearly demonstrate the health benefits that would result from the additional regulatory burdens. Speaking from the viewpoint of a state that has significant experience developing strategies to reduce ozone , we have plucked all of the low

- hanging fruit. All that is left is sev ere pruning.

You yourselves have noted that personal exposure to ozone is not considered in developing this standard as illustrated in your letter dated June 5, 2006:

“ The Ozone Staff Paper should consider the problem of exposure measurement error in ozo ne mortality time

- series studies. It is known that personal exposure to ozone is not reflected adequately, and sometimes not at all, by ozone concentrations measured at central monitoring sites....Therefore, it seems unlikely that the observed associations between short

- term ozone concentrations and daily mortality are due solely to ozone itself.”

Also, m any ecological studies have used patient medical records instead of patient histories to monitor exposure and assess health effects. P atient medical rec ords are inadequate indices to associate ozone exposure and health effects.

EPA also used clinic al studies published by D r
. William Adams as the basis for lowering the 0.08 ppm st andard. EPA reanalyzed D r
. Adams’ data using t

- tests rather than using a

mu ltiple comparisons post

- hoc test , as pointed out by D r
. Adams himself in his comments to EPA. This reanalysis would not pass peer review. You should not give EPA a pass on it either.

Your job in this process is to ensure that EPA uses good science in deciding where to set the ozone standard. You are not policy makers. You don’ t get to turn a blind eye to EPA’s inadequate science in the name of public health. You are suppose d to hold EPA accountable to use scientifically

- appropriate methodologies and analyses. You should3

make EPA explain the uncertainty in the ozone standard to poli cy makers so that the policy makers , not you and EPA scientists, can make an informed decision that wei ghs all relevant factors

.
In conclusion, a policy decision this important must not b e made just by using good science but also by under standing its limitations and uncertainties . The exposure estimates from the ecological epidemiology studies used to j ustify lowering the ozone standard do not account for personal exposure to ozone and are therefore faulty, as you yourselves have noted. It is scientifically

- inappropriate to use ecological epidemiology studies to set the ozone standard. EPA should use a ppropriate statistical analyses in looking at the Adams clinical data

.