### Comments Regarding CASAC Advice on Reconsideration of the 2008 Primary Ozone National Ambient Air Quality Standard

Prepared for the Alliance of Automobile Manufacturers

Jon M. Heuss Air Improvement Resource, Inc.

February 7, 2011
Introduction

As indic ated in Lydia Wegman’s January 25, 2011 Memo to Holly Stallworth of the EPA Science Advisory Board Staff , EPA is requesting additional advice from the C lean A ir
S cientific A dvisory C ommittee (CASAC) on the strengths and limitations of the scientific eviden ce at issue in the Administrator’s proposal for reconsideration. Although EPA is asking CASAC to focus on nine specific charge questions, the memo also indicates “...we would appreciate any further advice that CASAC wishes to provide.” In addition, the memo cautions that Panel members should be mindful that they should consider only information that was in the record of the 2008 NAAQS review. Finally, the memo indicates that the Administrator looks forward to CASAC’s consensus advice on the charge ques tions as she considers a standard in the range of 0.060 to 0.070 ppm.

The Alliance of Automobile Manufactures participated in the 2008 NAAQS review and the re

- consideration, providing detailed comments to the Agency. 1 Based on a review of the EPA reque st, we offer comments below on the specific charge questions. Our comments also refer to the locations in earlier submissions of the Alliance and other interested parties where further detail can be found. However, we respectfully begin with comments to CASAC on the framework and process being followed in the teleconference.

First, because of the importance of the choice of an ozone NAAQS that is sufficient to protect the public health but not more stringent than necessary, we encourage CASAC to go be yond the charge questions and provide additional advice. For example, we raise additional important questions in these comments that CASAC should address. Second, we urge the CASAC Panelists to provide their advice without artificially enforcing a

consen sus view. If there is consensus, or a range of opinion, that information should be

p rovided to the Administrator.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

1 Comments of The Alliance of Automobile Manufacturers on EPA’s Proposal for Reconsideration of the Primary and Secondary National Ambient Air Quality Standard s for Ozone, March 22, 2010

, Docket ID No. EPA

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. “Alliance Comments,”"

Third, we ask CASAC to consider whether the limited time for discussion of each question, less than 18 minutes per question in the draft A genda for the February 18, 2011 call , is sufficient to allow the Panel time to fully explore the issue and respond to the charge. In addition, there is no time on the Agenda to address other issues that Panelists may want to bring up. We would encourage the Panel to take the necessary time in a public format to discuss and develop its answers.

Fourth, we ask CASAC to address the difficulties the Panel faces because it is being asked to develop its views based only on the information available in the reco rd of the 2008 review. The 2008 review was based primarily on the February 2006 Criteria Document that assessed literature through 2004 along with selected studies published in
2005 and 2006 . It thus represents the state of science as of six years ago. S ince the Clean Air Act requires EPA to update the “criteria” every five years, it follows that the “re

consideration” is not based on the accurate and latest science envisioned by the Clean Air Act requirement. In addition, since the Panelists are aware o f the recent literature (and older studies that may be important but not included in the 2006 CD), it puts them in an awkward position to ask them to ignore new thinking about ozone health

- related science.

Fifth, with regard to the newest science, there is substantial new information that calls into question a number of key assumptions EPA made in the re

- consideration proposal. EPA carried out a 38

- page Provisional Assessment (PA) of the post

- 2006 CD literature at the time of the re

- consideration and rep orted that the newest literature does not materially change the conclusions of the Agency’s science assessment. However, a detailed analysis of the PA and the relevant literature by the Alliance indicates that the PA does not reflect the latest science be cause it completely overlooks several significant new scientific studies, is not a thorough assessment of the studies it does summarize, and omits consideration of new information concerning a key issue in the review, the background of ozone. We urge the CASAC panel to read the critiques of the PA submitted to the Agency by the Alliance 2 and by the National Association of Manufacturers 3 (NAM) prior to the February 18, 2011 teleconference.

Sixth, we believe that CASAC needs to provide the Administrator with additional advice concerning the limitations of the method used to estimate background ozone. In the 1997 Review, the Administrator found that a standard set at a level of 0.07 ppm was not requisite to protect public health in part because, based on the 1996 CD, an 8

– hour standard set at 0.07 ppm would be closer to peak background levels that infrequently occur in some areas due to non

- anthropogenic sources of ozone. In the 2008 Review,!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

2 Alliance Comments, supra note 1, Appendix A, Review of More Recent Relevant Studies to the Choice of Ozone NAAQS.

3 NAM, Attachment 1, A Detailed Review of the New Data in EPA’s Provisional Assessment and the New Data Excluded from the Assessment Does Not Support a Reduction in the Ozone
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EPA changed the way background was evaluated, relying solely on the use of a global atmospheric model to calculate mean background. EPA also neglected to estimate the extreme values of background even though the statistical form of the ozone NAAQS is an extreme value. This is an important omission that led the Agency and CASAC to assume, incorrectly, that a standard in the range of 0.06 to 0.07 ppm was substantially higher than background and achievable throughout the country.



### Comments on the charge questions

In the f ollowing, the eight charge questions are repeated and Alliance comments are provided, along with references to sections of earlier public submissions that provide additional detail.

1. What is your advice on the overall strengths and limitations of the evidence from controlled human exposure and epidemiological studies and the results of the exposure and risk assessments, in the context of EPA's selection of a standard level within the proposed range that would be requisite to protect public health with an adequate margin of safety, including the need to protect susceptible populations, such as children and people with asthma?

The controlled human exposure studies provide a strong and consistent body of information on the effects of 1

- to

- 3 hour and 8

- hour exposures to ozone. The first effects

- transient, reversible FEV 1 decrements

- are the body’s reflexive reaction to the presence of an irritant gas unrelated to sensations of discomfort. Such effects occur after exposures to 0.08 ppm for 6 to 8 ho urs when the subjects are exercising at a rate that would be considered strenuous when carried out intermittently for an eight

- hour period. Whether such effects occur at 0.06 or 0.07 ppm is highly controversial since the answer depends on how the basel ine is evaluated, how the precision of the test is considered, how the day

- to

- day variability of a subject is evaluated, and how the data is statistically analyzed. In either case, single incidences of the effects at 0.08 ppm (for either healthy or asthma tic subjects) were not considered to be adverse by CASAC and EPA staff in the 1997 review. Nothing in the body of controlled studies has changed to alter that view.

Since the first effects on the performance of lung function tests occur at 0.50 ppm in sedentary individuals, the vast bulk of personal exposures of either the general population or the susceptible population are far below the thresholds for the first effects identified in controlled studies. This provides a large margin of safety for the p opulation as they go about their daily activities

.
Other effects on the respiratory system , as discussed in the response to question #2, occur at higher concentrations as ozone triggers responses in the body’s defense mechanisms. Since the threshold for even the first indications of an inflammatory response is higher than that for the reflexive FEV 1 response, no adverse health effects are to be expected at either the current 0.075 ppm standard or a more stringent standard.

In contrast to the controlle d studies, the epidemiological studies have severe limitations$

beyond those already acknowledged by the Agency. These limitations are discussed in the answer to questions #6 and #8 and in detail in the Alliance Comments Appendix B at pages 17 to 35. 4 Bas ically, the full pattern of results in comprehensive studies demonstrates a biologically implausible wide range of results from positive to negative and spatial and temporal variability that is not consistent with the spatial and temporal distribution of o zone. Therefore, it is inappropriate to assume that ozone is causing premature mortality or hospital admissions. The full pattern of results demonstrates a heretofore underestimated stochastic variability in the data. Although there may be somewhat more positive associations than negative associations in comprehensive studies, there is so much noise or variability in the data that identifying which positive associations may be real health effects and which are not is beyond the capability of current meth ods. Based on the body of controlled studies, a standard at the upper end of the range or the current 0.075 standard would adequately protect the public health

.

2. Recognizing that controlled human exposure studies at 0.080 ppm O 3 and above have provided evidence of other health effects, including inflammation and increased airway responsiveness which may occur through different physiological mechanisms than the reduction in FEV 1 , how should the results of these studies inform our understanding the health effects to healthy adults at exposures levels from 0.060 to 0.070 ppm?

As noted in the answer to question #1, o ther effects on the respiratory system occur at higher concentrations than those that cause FEV 1 decrements as ozone triggers responses in t he body’s defense mechanisms. For example, the immune system responses noted by
EPA as the first indications of “inflammation” are physiological processes that occur in all living organisms under the stimuli of daily life. The first reported changes (tha t occur in humans with heavy exercise after 1

- to 3

- hours above a threshold of 0.18 to 0.20 ppm) are small and reversible and well within the range of physiological variability. They fall into the category of biochemical markers that the American Thoracic Society indicates do not necessarily imply adversity. The review by Mudway and Kelly 5 note s that for neutrophils transiting into the lung

-- one of the earliest of these responses

-- it is not clear if the response should be considered beneficial (functi oning to clear necrotic cells) or detrimental (leading to an active inflammation with tissue injury). The 2006 CD notes that generally, “the initiation of inflammation is an important component of the defense process; however, its persistence and/or its r epeated occurrence can result in adverse health effects.” Since the threshold for even the first indications of an inflammatory response are higher than that for the reflexive FEV 1 response, no adverse health effects are to be expected at either the curre nt 0.075 ppm standard or a more stringent standard.

Another effect that occurs at somewhat higher exposures than the FEV 1 decrements are mild symptoms and sensations of discomfort. These are also transient and reversible.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

4 Alliance Comments, supra note 1, Appendix B, Comments of the Alliance of Automobile Manufacturers on EPA’s Proposal to Revise Ozone NAAQS, filed October 9, 2007.

5 I. Mudway and F. Kelly, Ozone and the Lung: A Sensitive Issue , Mol. Aspect. Med., 21, 1

- 48 (2000).%

Thus, the inflammatory and ot her responses at 0.08 and higher ozone exposures when exercising do not inform the understanding of effects in the 0.06 to 0.07 ppm range. Additional relevant discussion can be found at pages 9

- 11 and 35

- 36 of Appendix B of Alliance Comments.

3. How shou ld the results of the controlled human exposure studies at 0.060 ppm
O 3 , showing effects on FEV 1 and respiratory symptoms, in the context of the larger body of evidence from controlled human exposure studies, mentioned above, inform our understanding of th e health effects to healthy adults at exposure levels from 0.060 to 0.070 ppm?

The controlled human exposure studies provide a strong and consistent body of information on the effects of 1

- to

- 3 hour and 8

- hour exposures to ozone. The first effects

- t ransient, reversible FEV 1 decrements

- are the body’s reflexive reaction to the presence of an irritant gas unrelated to sensations of discomfort. Such effects occur after exposures to 0.08 to 0.12 ppm for 6 to 8 hours when the subjects are exercising at a rate that would be considered strenuous when carried out intermittently for an eight

- hour period.

Whether such effects occur at 0.06 or 0.07 ppm is highly controversial since the answer depends on how the baseline is evaluated, how the precision of the test is considered, how the day

- to

- day variability of a subject is evaluated, and how the data is statistically analyzed. Public comments by the National Association of Manufacturers 6 and the Alliance 7 provide more detailed discussions of this issue.

The Alliance points out that the small group mean changes that are at issue are well within the range of normal measurement variability and well below the 10 to 20% changes which are considered moderate and potentially of health concern in the S taff
P ap er

. Thus, the appropriate question in interpreting these studies is not whether there are small changes in the performance of lung function tests, but what these small changes mean for public health given the involuntary reflex mechanism causing the chang es

. NAM documents that a variety of environmental exposures and stresses to which many people, including children, are routinely exposed produce changes in pulmonary function

tests of the same magnitude as proposed as “exposures of concern” for the ozone NAAQS. Many children experience minor exposures and stresses that result in transient
FEV 1 decreases of 10

- 15%. Further, in some cases, these routine changes or effects occur consistently rather than infrequently, i.e. once per year.

In the 1997 review, single incidences of the FEV 1 effects at 0.08 ppm (for either healthy or asthmatic subjects) were not considered to be adverse by CASAC and EPA staff

.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

6 NAM, Attachment 2, Critical Review of the Health Data in EPA’s 2008 Proposed NAAQS for Ozone Cited in the Current 2010 Proposed Rulemaking, Docket ID No. EPA

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7 Alliance Comments, Appendix B, at pages 9

- 11.&

There was considerable discussion of this in the Staff Paper at that time. Nothing in the body of contr olled studies has changed to alter that view. The acute decrements are transient, reversible decrements in the performance of the lung function test (that requires maximal inspiratory effort) due to a protective reflex and not a change in long

- term lung fu nction of any clinical or pathological significance.

The threshold for these first effects varies depending on ozone concentration, time of exposure and breathing rate. Since the first effects on the performance of lung function tests occur at 0.50 ppm in sedentary individuals, the vast bulk of personal exposures of either the general population or the susceptible population are far below the thresholds for the first effects identified in controlled studies. This provides a large margin of safety for th e population as it goes about its daily routine.

The new data extending lung function effects to lower concentrations establishes that the response is non

- linear in contrast to the linear assumption made in the 1997 review. This means that, for a given ozone exposure below the current standard, the risk of lung function decrements is now lower than thought in the 1997 review, when the standard was lowered to 0.08 ppm. The Second Draft S taff P aper in the 2008 review included a statement that the risk estimates “ are now appreciably lower than in the last review.” 8

The final S taff P aper removed the statement but the risk estimates remained.

Given these facts, making the ambient ozone standard more stringent with the aim of reducing the number of transient pulmonary fun ction events and the number of “exposures of concern” will not likely have any e ffect on children’s or adult’s health.

4. With respect to the information from controlled human exposure studies at 0.060 ppm O 3 , what is the scientific importance of t he small, group mean FEV 1 decrements relative to the findings that 7 to 20% of the subjects experienced FEV 1
decrements > 10%? Please consider this question from both a public health and a clinical perspective.

As discussed in the answer to question #2, small group mean FEV 1 decrements, whether or not statistically significant

, are not medically significant. The EPA focus on a subset of responses in the 7 to 20 % range is also problematic since the Adams 2006 study was not designed to test for the pr esence or absence of high responders. EPA focuses on so

called responders but to have a very small mean difference in the presence of some larger decrements means that there are also subjects whose FEV 1 increased during the exposure. Thus, there is subst antial variability in the subject’s responses. For example, the range of individual FEV 1 changes in the filtered air group in these studies was

- 6.0 to 12.4 %.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

8 U.S. Environmental Protection Agency, Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information, OAQPS Staff Paper

- Second Draft , EPA

- 452/D

- 05

- 002, July 2006, at pages 5

- 71 and 6

- 27.'

Dr. Roger McClellan, a former member and chair of CASAC, who has followed the human health ef fects literature for many years and Dr. Regis McFadden, a Professor of Medicine and a pulmonary physician with much research and clinical experience with asthmatics, have questioned EPA’s interpretation of the data. 9 Dr. McClellan has indicated that t he v alidity of EPA’s reinterpretation of the data and the significance of the functional changes are debat abl e. Dr. McFadden describes the reported FEV 1 decrements in Adams’ subjects when exposed to an ozone concentration of 0.08 ppm or less as “quite minimal and likely nondetectable by the subjects.” Dr. McFadden does not regard such events as medically significant. He notes that the symptoms reported were barely discerned and the maximum effect (at 0.08 ppm) represented only a 6% increase over control. For e xample, the total mean symptom scores on the scale reported by Adams (2006) were only 2

- 4 units at 0.04 and 0.06 ppm out of a possible total score of 160. Adams had indicated that the differences in the symptoms between the 0.04 and 0.06 ppm exposures and the filtered air control were not significant. As the NAM Attachment 2 comments point out, EPA’s conclusions concerning the variability in individual response and a higher level of response in a small subset of individuals are speculative and should

not be used as a basis for a revised NAAQS.

5. The evidence, including that summarized above, indicates that susceptible populations may have greater responses than healthy people. In light of this evidence, how can we appropriately use the results of co ntrolled human exposure studies conducted on healthy adults, as well as the epidemiological studies of susceptible groups, to inform a judgment on the effects of ozone exposure on susceptible populations?

With regard to the controlled studies, Dr. McFadd en also reviewed the clinical data on whether asthmatics or other susceptible populations may have greater responses than healthy people as well as EPA’s arguments as to why this might be the case. He concluded that the data at 0.12 ppm and higher do not show any major effects on asthmatics. He described EPA’s arguments as to why there might be greater concern as a series of unproven assumptions. He concludes the assumption s remain an unproven theo ry regarding whether the responses seen in controlled st udies would lead to clinical manifestations in terms of exacerbations of asthma or other adverse health effects.

Dr. McFadden provides a number of reasons for his conclusion that transient decreases in FEV, of 10

- 20% are not by themselves significant or meaningful to asthmatics. He points out that based on his e xperience from examining and studying thousands of patients for both clinical and research purposes that asthmatics typically will not begin to sense bronchoconstriction until their FEV 1 falls abo ut 50% from normal. By way of comparison, he notes that asthmatic patients presenting to a physician or emergency room for treatment of acute exacerbations of their illness often have decreases in FEV 1 of 65

-!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

9 Comments of E. R. McFadden, Jr., M.D. on Health Signific ance of Asthmatics' Responses Reported in Clinical Studies of Short

- Term Ozone Exposure, September 14, 2007, Docket ID No.
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70% from normal. In addition to Dr. McFadden’s statement in the record, there are statements in the record by eight other Medical Doctors concerning the lack of clinical significance of transient, reversible FEV 1 decrements of 10 to 20 % for asthmatics. 10

With regard to the epidemiological data, the Al liance Appendix B comments at pages 22 and 23 point out while there are some positive associations that implicate ozone as a responsible pollutant, taken as a whole the studies are mixed and inconsistent with regard to ozone and often implicate other pollu tants. Overall, the data on susceptible populations is not any stronger than understood or assumed in the 1997 review. Th e mixed and inconsistent pattern is not surprising given the substantial stochastic variability in the data that is not acknowledged by the Agency. A large component of stochastic variability that goes well beyond just heterogeneity of response is apparent in the data from multi

- city studies or comprehensive studies. T he kinds of respiratory responses that EPA hypothesizes may occur i n human populations from current ozone levels are not consistently seen in observational studies and

, to the extent they are, the associations often implicate pollutants other than ozone . Therefore, there is little support for assuming that susceptible in dividuals are experiencing greater ozone effects than healthy individuals.

6 . To what extent does your confidence that the effects observed in epidemiological studies are attributable specifically to O 3 lessen or otherwise change, if at all, at the
low er levels in the proposed range as compared to the higher levels ?

This question is quite specific. Instead, EPA should be asking CASAC more generally about the interpretation of epidemiological studies as it informs the Administrator’s decision. For e xample, the American Petroleum Institute offered additional questions regarding epidemiology that address key issues in the interpretation of the epidemiology

- geographic heterogeneity, confounding by other pollutants and possible “double

counting” of eff ects, and the implications of the no

- threshold assumption. 11 We urge CASAC to address all these issues.

The “effects” observed in epidemiological studies are associations not necessarily effects caused by or exacerbated by ozone. The overall pattern of as sociations in multi

- city studies and in comprehensive studies in single cities is not biologically plausible. Analysis of time

- series single

- city associations in large multi

- city studies such as the National Morbidity and Mortality Air Pollution Study (N MMAPS), shows significant variability of positive and “negative” associations unaccounted for in the published literature or EPA’s analysis. Such a wide range that includes both strong positive and strong negative associations goes well beyond heterogen eity of response and is not biologically plausible.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

10 A list of the statements is provided in Docket ID No. EPA

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11 January 25, 20 11 letter from Howard Feldman to Assistant Administrator Regina McCarthy,
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Air pollution time

- series epidemiology studies suffer from problems associated with publication bias, model uncertainty, model selection issues, lack of adequate control for confounding variables su ch as other pollutants and weather, and exposure misclassification arising out of the poor correlation between ambient monitors and personal exposure. In its June 2006 letter to the Administrator, CASAC confirmed this view in evaluating mortality time

- seri es studies, noting that “[b]ecause results of time

series studies implicate all of the criteria pollutants, findings of mortality time

- series studies do not seem to allow us to confidently attribute observed effects specifically to individual pollutants.” 12

With regard to assuming that ozone associations are causal, there are a number of additional problems. Because of the wide range in individual city associations, shown for example in Figure 7

- 17 of the 2006 CD, combined results are usually presented

. However, the combined association in winter is actually negative, so the emphasis in the literature has been on evaluating summer

- only or all

- year associations. It is incomprehensible that ozone would be causing mortality in the summer but protecting

ag ainst mortality in the winter. The Agency has not fully evaluated all the possible reasons for this discrepancy and their policy implications. In multi

- pollutant models for the summer case, the combined positive ozone association was reduced and became n on

significant at all three lags evaluated as shown in Figure 7

- 31 of the CD.

In addition to the literature considered in the 2008 review, there is now a larger data base of multi

- city studies which can inform the Administrator’s decision. A full conside ration of the ramifications of these studies would change the Administrator and CASAC judgments regarding an independent ozone mortality effect. Alliance and NAM comments summarize these studies. 13 In October, 2009, the Health Effects Institute (HEI) publi shed Air Pollution and Health: A European and North American Approach (APHENA). 14 The APHENA project was designed to take advantage of the largest databases available, in the U. S. Europe, and Canada. As documented in the Alliance and NAM submissions, t he pattern of combined associations reported in the APHENA study does not support EPA’s claims of causal relationships between ozone and mortality or between ozone and hospital admissions.

There are at least six new multi

- city studies that have evaluated ozone associations with mortality or hospital admissions since the 2006 CD. All the studies that report or plot the individual

- city associations show a biologically impossible wide range of associations from positive to negative for mortality and hospita l admissions. We note two relevant findings.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

12 R. Henderson, CASAC Letter, EPA

- CASAC

- 06

- 07, June 5, 2006 at page 3.

13 Alliance Comments Appendix A and NAM Comments Attachment 1.

14 Katsouyanni K. and Samet, J. (2009). Air Pollution and Health: A European and North American Approach (APHENA), Health Effects Institute Report 142, October, 2009.+,

When Bell et al., 2007 15 restricted the analysis to days with low ozone, in order to see if the small combined association persisted, the range in individual

- community associations widened. For example, when the data was restricted to days with ozone less than 20 ppb, the range in individual city mortality associations for a 10 ppb increase in ozone was from

– 20 % to + 30 %. It is inconceivable that such low ozone exposures would be causing a dramatic increa se in mortality in one city and protecting against mortality in another. With such wide variation, the interpretation of a small combined association as a health effect is highly questionable.

There also is strong evidence of regional differences in ozon e associations that are not consistent with ozone causing mortality. Bell and Dominici, 2008 16 and Smith, Xu, and Switzer, 2009 17 present results of combined associations broken down into the seven regions of the U.S. that were used in the NMMAPS PM studies . The combined ozone associations are significant and positive in some regions and negative or null in other regions. The spatial pattern is not consistent with ozone causing mortality. The spatial pattern, however, is similar to that for PM suggesting t hat ozone may be acting as an indicator of toxic PM constituents that are prevalent in some parts of the U. S. Other possible explanations also need to be considered.

Since the spatial and temporal pattern of associations in multi

- city studies is not

cons istent with ozone causing premature mortality, the Agency should not assume that ozone has an effect on mortality at the levels under consideration.

7 . EPA’s exposure assessment quantified the number of all children and asthmatic children likely to be e xposed to specific benchmark levels of ozone, including in particular 0.060 and 0.070 ppm. Considering the patterns of change in the estimates of exposures of concern at and above the 0.060 and 0.070 ppm benchmark levels,
and the uncertainties and limita tions in the estimates, what is the relative importance from a public health perspective of the estimated reductions in exposures of concern, as well as the exposures remaining, for alternative standards across the proposed range?

The exposure/exertion protocols used in the human clinical studies do not mimic typical human behavior so the results must be mapped onto realistic exposure/activity scenarios to determine the risk. The chance of experiencing an exposure of concern requires that a person be o utside, at the location of the high ozone, at the time of peak ozone, and exercising heavily. During the 1996/1997 review, EPA staff undertook an extensive!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

15 Bell ML, Kim JY, Dominici F. Potential confounding of particulate matter on the short

- te rm association between ozone and mortality in multisite time

- series studies. Environ Health Perspect 2007;115:1591

- 5.

16 Bell ML, Dominici F. Effect modification by community characteristics on the short

- term effects of ozone exposure and mortality in 98 U.S. communities. Am J Epidemiol 2008;167:986

- 97.

17 R. L. Smith, B. Xu, and P. Switzer, Reassessing the Relationship Between Ozone and Short

term Mortality in U.S. Urban Communities, Inhalation Toxicology, 29(S2), 37

- 61, 2009.++

exposure and risk assessment with input from CASAC. To estimate the risk, staff made a series of co nservative assumptions. For example, the analysis used an algorithm to assign ventilation rates based on individuals who exercised regularly and were motivated to reach a high ventilation rate. As a result, the 1996 Staff Paper acknowledged that the

ana lysis allowed more high ventilation rates (hence greater risk) than would actually occur in the populations of interest

-- outdoor workers, outdoor children, etc.

The 2008 review included an update to the exposure and risk assessment. The APEX model developed estimates of the number of all school age children and asthmatic school age children exposed one or more times a year to various 8

- hour ozone concentrations (0.06 ppm, 0.07 ppm, and 0.08 ppm) while undergoing moderate exertion in a number of urba n areas. These exposure metrics are discussed as benchmark “exposures of concern.” The Agency noted that only a subset of the individuals in these groups would actually be expected to experience effects. To the extent that there are significant biases in the exposure and risk assessment, the interpretation of the public health protection afforded by either the current standard or various alternatives would change.

The Alliance Comments document at least five ways in which the clinical exposure and risk a ssessment is biased, overstating the exposures and risks that would accompany any of the alternative standards under consideration. Specifically, there are three ways that the APEX model used in the current risk assessment overestimates the number of

occu rrences of elevated 8

- hour ozone exposures during strenuous work or play 18 and two ways in which the Risk Assessment (RA) overestimates the benefits of alternative standards. 19 Details can be found at pages 13 to 17 of Appendix B to the Alliance
Comments. The American Petroleum Institute has also provided a detailed analysis that indicates that the exposure analysis overestimates the exposures of concern by at least a factor of three. 20

Since there is substantial evidence that the exposures assessment overe stimates the number of exposures of concern at any given ozone level, the estimated reductions from a more stringent standard shown in Table 3 of the January 19, 2010 proposal are also overestimated. Thus, the results of the exposure assessment overstate the impacts of a more stringent standard and should not be used until the biases are removed.

8 . EPA’s quantitative risk assessment estimated the numbers of occurrences of various ozone

- related health effects associated with just meeting alternative
stand ard levels down to a standard level of 0.064 ppm. Considering the patterns of change in the estimates of health effects in the risk assessment at the alternative!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

18 The model does not corre ct for ozone at person height compared to ozone at measurement height; the model treats the upper tail of the distribution of breathing rates incorrectly; t he model predicts substantially more elevated ventilation rate occurrences than observed in real world data.

19 The way the model rolls back ambient concentrations does not mimic the changes that will
occur as emissions are reduced and man

- made ozone is reduced; the background ozone assumed
in the risk assessment is too low

. 20 Docket ID No. EPA

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standard levels, and the uncertainties and limitations in the estimates, what is the relative importance from a public health perspective of the estimated reductions in risk, as well as the risk remaining, for alternative standards across the proposed range? Please consider this question in light of the scientific evidence as a whole.

The ris k assessment included estimates of the lung function responses for various alternative standards as well as effects estimated from selected epidemiological associations. Each will be discussed in turn.

For the lung function responses, the exposures from the APEX model were used with dose

- response functions for FEV 1 changes to estimate the number of moderate or greater lung function responses for all and asthmatic school age children. It is important to recognize, as noted above, that the lung function r isk estimates are now appreciably lower than in the 1997 review when the 0.08 ppm standard was established. It is also important to recognize that the risk estimates are biased high because of the five factors referred to above that are discussed in the A lliance comments. Thus, the estimated number of lung function decrements reported in Table 2 of the January 19, 2010 proposal are substantial overestimates. In addition, incidences of exposure that might be expected to lead to decrements in the performan ce of lung function tests would not be discernable to the adult or child. In previ ous reviews of the ozone NAAQS, single incidences have not been deemed as adverse. The extreme value form of the current 8

- hour standard, in itself, drastically limits the number of potential repeat exposures, providing a substantial margin of safety. Thus, for respiratory effects that we know are caused by ozone, the current standard is highly protective.

With regard to the risk estimates from epidemiology, there is su bstantial controversy over whether ozone is causing effects below the current standard. As noted above, the overall patterns in the ozone associations in comprehensive or multi

- city studies are not biologically plausible. The Agency asserts plausibility by selecting positive associations from the literature. However, the mean personal exposures of the population are at or below the mean background, when considering the fact that people spend 90 percent of their time indoors where ozone concentrations ar e significantly lower than ambient. Such personal exposures do not trigger FEV 1 responses through the vagal mechanism and have not been shown to trigger inflammation. It is not clear how such low personal exposures could cause or contribute to the prema ture mortality or hospital admissions estimated in the risk assessment. Alliance Comments Appendix B at pages 17 to 35 and NAM comments Attachment 2 at pages 30 to 43 provide additional detail concerning the interpretation of the epidemiological results. As noted above, studies published since the
2006 CD confirm spatial and temporal pattern s in the ozone mortality associations that are not consistent with causality.

Because of all the issues with the epidemiology, the Administrator should heavily disco unt the quantitative risk assessment using epidemiological associations. Instead, as EPA has reviewed the five criteria pollutants for which time

- series epidemiology is available, by focusing on selected single

- pollutant model results the Agency has claim ed independent effects from four of the five pollutants. This is not scientifically defensible.Before the

ENVIRONMENTAL PRO TECTION AGENCY

Docket No. EPA–HQ–OAR–2005–0172

National Ambient Air Quality Sta ndard for Ozone; Proposed Rule

75 Fed. Reg. 2938 (January 19, 2010)

Comments of

THE ALLIANCE OF AUTOMOBILE MANUFACTURERS

March 22, 2010

For more information, please contact Giedrius Ambrozaitis (gambroz aitis@autoalliance.org) or Susan Conti (sconti@autoalliance.org)

Alliance of Automobile Manufacturers 1401 Eye Street N.W., Suite 900

Washington, D.C. 20005-6562

Telephone: (202) 326-5512! !

"! 

### THE ALLIANCE OF AUTOMO BILE MANUFACTURERS
COMMENTS ON EPA’S PROPOSAL FOR RECONSIDERATION OF THE
PRIMARY AND SECOND ARY NATIONAL AMBIENT AIR QUALITY STANDARDS (NAAQS) FOR OZ ONE. 75 Fed. Reg. 2938 (January 19, 2010) Docket ID No. EPA–HQ–OAR–2005–0172

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EXECUTIVE SUMMARY

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DETAILED COMMENTS

4< >@4!B%'(*&/2%-&!"YYX!D44E=!6(-!FG(*%!

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CONCLUSION

! #$%!D44E=!-%?/%T!:-('%&&M!T/+$!/+&!,++% *2,*+!`*+%0-,+%2!='/%*'%!4&&%&&)%*+!+$,+! /*+%0-,+%&!,55!+$%!5,+%&+!,*2!)(&+!,''1-,+%!&'/%*' %!,*2!%^,)/*%&!/+&!-%&15+&!,*2!&$(-+'()/*0&!/*! 2%+,/5M!/&!+$%!)(&+!&(1*2!&'/%*+/6/' !T,3!+(!:-('%%2<!!`+!/&!,5&(! +$%!:-('%&&!+$,+!+$%!N44!-%]1/-%&<! 4*3+$/*0!5%&&!+$,*!,!6155!,*2!'():5%+%!,*,53&/&!+$ ,+!/*'512%&!+$%!)(&+!'1 --%*+!&'/%*'%!-/&C&!/&! /*,2%]1,+%!,*2!&1.j%'+&!+$%!(?%-, 55!:-('%&&!+(!1**%'%&&,-3!2%5,3&! ,*2!1*&(1*2!&'/%*+/6/'!-%&15+&<!! >@4A&!-%5/,*'%!(*!,!:-(?/&/(*,5!-%?/%T!+$,+!/&!*%/+$ %-!+$(-(10$!*(-!&'/%*+/6/' !/*!/+&!,::-(,'$!/&! '(*+-,-3!+(!+$%!&+,+1+(-3!-%]1/ -%)%*+&!6(-!D44E=!-%?/%T!,*2! '(*65/'+&!T/+$!+$%!0(,5&!,*2! (.j%'+/?%&!,-+/'15,+%2!.3!42)/*/&+-,+(-!Q,'C&(*<! !#$%!40%*'3!&$(152!/* /+/,+%!,!6155!,*2!:-(:%-! &'/%*+/6/'!-%?/%T!,*2!/&&1%!,!*%T!:-(:(&,5M!/*! ,''(-2,*'%!T/+$!+$%!N44!D44E=!-%?/%T!:-('%&&<!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ! c%*2%-&(*M!B<!8"YYX9!O%++%-!6-()!N4=4N!N$,/-),*!B(0%*%!c%*2%-&(*!+(!>@4!42)/*/&+-,+(-!=+%:$%*!Q($*&(*<! 4:-/5!UM!"YYXM!>@4gN4=4NgYXgYYe<!!45&(!&%%!FG(*%!D44E=!B%'(*&/2%-,+/(*!:-(:(&,5!,+!:,0%!"ee"!T/+$!-%0,-2! +(!+$%!:-/),-3!&+,*2,-2!,*2!,+!:,0%!bY[X!T/+$!-%0,-2!+(!+$%!&%'(*2,-3!&+,*2,-2<!!!U\!P%2<!B%0<!"ee"M!Q,*1,-3![eM!
"Y[Y<! !

e! 

### APPENDIX A

REVIEW OF MORE RECENT STUDIES
RELEVANT TO THE CHOI CE OF OZONE NAAQS

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The APHENA study was not included in the Pr ovisional Assessment and does not support EPA’s claims of causal relationships between ozone and mortality or between ozone and hospital admissions.

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! #$%!4@c>D4!-%&15+&!2(!*(+!&1::(-+!>@4A&!'5,/ )&!(6!',1&,5!-%5,+/(*&$/:&!.%+T%%*!(G(*%! ,*2!)(-+,5/+3!(-!.%+T%%*!(G(*%!,*2!$(&:/+,5!,2)/&&/(*&<!#$/&!/&!&$(T*!/*!#,.5%![!6(-!)(-+,5/+3! ,*2!/*!#,.5%!"!6(-!$(&:/+,5!,2)/&&/(*&<!!

Table 1: APHENA modeling results for mortality

Cause of Death Canada Europe United States

455!N,1&%!g!,55!,0%&! "Vl"V! [\l"V! ["l"V!!!!!!!!!!!!!!!!!!!!! ! !U\!3-&! "bl"V! "l"V! Zl"V!

!!!!!!!!!!!!!!!!!!!!m!U\!3-&! [Xl"V! ""l"V! [Yl"V!

455!N,1&%!@7!'(*+-(55%2! g!,55!,0%&! VlX! Xl[Z! Yl[Z!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ! !U\!3-&! YlX! bl[Z! Yl[Z!

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!m!U\!3-&! \lX! [Vl[Z! Yl[Z!

455!N,1&%!g!&1))%-!(*53! ele! [Xl[X!8Vl["9n [Xl[X8Yl["9n!

N,-2/(?,&'15,-!g! ! !U\!3-&! "Vl"V! bl"V! "l"V!

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!m!U\!3-&! Yl"V! Xl"V! "l"V!

N,-2/(?,&'15,-!g@7!'(*+-(55%2! ! !U\3-&! YlX! Yl[Z! Yl[Z!

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!m!U\!3-& YlX! \l[Z! "l[Z!

N,-2/(?,&'15,-!g!&1))%-!(*5 3! YlZ! Xl["8YlX9 n! [[l["8YlX9n!

B%&:/-,+(-3!g!,55!,0%&! Yl"V! Yl"V! Yl"V!!!!!!!!!!!!!!!!!!!!!!!! ! !U\!3-&! Yl"V! Yl"V! Yl"V!

B%&:/-,+(-3!g!@7!'(*+-(55% 2!g!,55!,0%&! YlX! Yl[Z! Yl[Z!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ! !U\!3-&! YlX! Yl[Z! Yl[Z!

B%&:/-,+(-3!g!&1))%-!(*53! ZlZ! Vl["8YlX9 n! "l["8YlX9n!

n_%*(+%&!+$%!@7!'(*+-(55%2!-,+/(!

#$%!*1)%-,+(-&!-%:-%&%*+!+$%!*1).%-!(6!)(2%5& !+$,+!&$(T%2!,!:(&/+/?%!,*2!&+,+/&+/',553! &/0*/6/',*+!-%5,+/(*&$/:!.%+T%%*!F b !,*2!)(-+,5/+3M!T$/5%!+$%!2%*()/* ,+(-!/&!+$%!+(+,5!*1).%-!(6! )(2%5&!-1*<!! !

[b! Table 2: APHENA Modeling Results for Hospit al Admissions for Patients 65 Years and
Older

Type of Admission Canada Europe United States

B%&:/-,+(-3! [Xl"V! Xl"V! Ul"b!

B%&:/-,+(-3!g!@7!' (*+-(55%2! YlX! Ul[Z! \l[Z!

B%&:/-,+(-3!g!&1))%-!(*53! blb! YlV! YlV!

N,-2/(?,&'15,-! \l"V! Yl"V! bl"V!

N,-2/(?,&'15,-!g!@7!'(*+-(55%2! blX! [Zl[Z! Yl[Z!

N,-2/(?,&'15,-!g!&1))%-!(*53! YlV! YlV! YlV!

#$%!*1)%-,+(-&!-%:-%&%*+!+$%!*1).%-!(6!)(2%5& !+$,+!&$(T%2!,!:(&/+ /?%!,*2!&+,+/&+/',553! &/0*/6/',*+!-%5,+/(*&$/:!.%+T%%*!F b !,*2!,2)/&&/(*&!T$/5%!+$%!2%*()/* ,+(-!/&!+$%!+(+,5!*1).%-!(6! )(2%5&!-1*<!

Based on new studies subsequent to the 2006 CD, !+ he pattern of results in new multi-city studies of mortality and hospital admissions is not consistent with ozone having a causal role in mortality or morbid ity below the current standard.

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Controlled exposure studies published subsequent to the CD continue to show no medically significant effect s below 0.08 ppm.

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Studies published subsequent to the 2006 CD rais e issues relevant to the Agency’s assumed background of ozone.

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### APPENDIX B

COMMENTS OF THE ALLIANCE OF AUTOMOBILE
MANUFACTURERS ON EP A’S PROPOSAL TO RE VISE OZONE NAAQS 72 FED. REG. 37,818 (JULY 11, 2007)

OCTOBER 9, 2007

### BEFORE THE

ENVIRONMENTAL PROTECTION AGENCY

Docket NO. EPA-HQ-OAR-2005-0172

National Ambient Air Quality Standards for Ozone; Proposed Rule

Comments of



### THE ALLIANCE OF AUTOMOBILE MANUFACTURERS

October 9, 2007

Gregory J. Dana Vice President - Environmental Affairs Alliance of Automobile Manufacturers 1401 Eye Street NW, Suite 900 Washington, DC 20005-6562 (202) 326-5518 (tel) (202) 326-5568 (fax)

email: gdana@autoalliance.orgii TABLE OF CONTENTS Page

EXECUTIVE SUMMARY ............................................................................................... 2

DETAILED COMMENTS ............................................................................................... 7

Introduction.................................................................................................................. 7

I. Comments on EPA’s Proposal to Revise the Primary Standard for Ozone ........................................................................................................... 8

A. The Clinical and Epidemiology Evidence Indicate Less Risk from Ozone Exposure than in 1997 .......................................................... 8

1. The risk of respiratory effect s is substantially reduced from what was estimated in the 1997 Review............................................. 8

2. The clinical data do not support the reversal of EPA’s 1997 determination that the current standard is requisite to protect the public health with an adequate margin of safety .......................... 9

3. EPA’s risk assessment based on the clinical studies does not support the conclusion that a ti ghtening of the standard is requisite to protec t the public health................................................... 12

B. Time-Series Studies Do Not Provi de Support for Causality of Effects But Instead Confirm Si gnificant Uncertainties Present in the 1997 Review ............................................................................................. 17

1. In interpreting the epidemiological evidence, EPA downplays the major new findings concerning uncertainty due to model selection issues ................................................................................... 17

2. In interpreting the epidemiological studies, EPA relies on single estimate and single-site analyses and fails to address the effect of publication bias............................................................... 19

3. Analysis of more complete data sets, such as NMMAPS, suggests significant variab ility of positive and “negative” responses unaccounted for in the published literature or in EPA’s analysis ............................................................................. 20iii 4. EPA has a duty under the Data Qu ality Act to consider all the results, including both positive and non-positive results ................................................................................................ 21

5. The new data on asthmatics and symptoms/medication use does not provide clear and convincing evidence of an increase in risk due to ozone exposure that was not present in the 1997 Review ............................................................................. 22

6. The claim that a more stringent ozone standard will address the growing asthma problem in the U.S. is without scientific merit ................................................................................................... 23

a. There is no evidence that ozone levels at or below the current standard cause asthma

................................................. 23

b. The epidemiology data do not show that ozone levels at or below the current standard cause asthma ............................... 24

C. The Evidence on Premature Mortality is too Limited in Nature and Should Not Be Relied Upon in Basing Conclusions on the Health Effects from Exposure to Ozone................................................................ 24

1. CASAC itself had reservations on the use of the data........................ 25

2. A new NMMAPS analysis th at extends the previous analyses, and the Huang et al. (2005) analysis of a subset of 19 large U.S. cities is limited, and does not support a finding of causality .............................................................................................. 25

a. There are major deficiencies in the Bell et al. 2004 paper, including the omission of the winter ozone results and limited analyses regarding other pollutants .............................. 25

b. The pattern of individual-city a ssociations in the Huang et al. study is not consistent w ith a causal association, and may reflect the confounding role of another pollutant .................... 26

3. While the SP downplays confounding by co-pollutants, a more comprehensive review of the data implicates other pollutants as potential causes of the reported mortality associations in time-series studies .......................................................................... 27iv 4. Weather factors remain a ke y confounder in the mortality analysis relied on by EPA................................................................... 28

D. EPA’s Risk Estimate for Mort ality and Certain Respiratory Endpoints Fail to Confirm an Increase in Risk ......................................... 29

1. New studies on emergency room visits and hospital admissions do not provide supporting evidence of a causal relationship ....................................................................................... 33

2. Overall the school absence data are weaker than noted in the proposed rule and do not confirm causality or effects below the current standard .......................................................................... 35

E. EPA Improperly Characterizes th e Impact of New Information Since the Last Review, Particularly as it Relates to Mechanisms of Ozone Action and Support for Causal ity of Mortality and Other Important Epidemiological Health Endpoints .......................................... 35

F. The Clean Air Act Does Not Require EPA to Set Standards That Eliminate All Risk .................................................................................. 39

G. Since EPA Has Not Provided a Reasonable Analysis Supporting its New Judgment on What is Requ isite to Protect Public Health or Welfare, its Actions Could Be Found to Be “Arbitrary and Capricious” ................................................................................................ 40

H. EPA Has Not Correctly Evaluate d the Potential Risk Reduction as a Result of its Proposed Change to the Current Ozone Standard ..................................................................................................... 40

1. In contrast to the 1997 Revi ew, EPA failed to evaluate the extreme values of ozone background levels ...................................... 41

2. EPA’s definition of PRB incorrectly excludes man-made emissions from Canada and Mexico........................................... 42

3. EPA does not provide sufficient rationale for relying on modeled results over monitoring data for assessing background ambient ozone levels ...................................................... 42v 4. The proposed rule ignores the conclusions of several researchers and previous conclusions of EPA regarding maximum background levels ............................................................ 43

5. Because the PRB varies subs tantially there will be times and places where the backgr ound approaches or exceeds the levels recommended by CA SAC for both the primary and secondary standards .................................................................... 45

6. The lack of consideration of the extremes of ozone background levels is an omission that led both the Agency and CASAC to assume that the recommended standards are attainable............................................................................................. 45

I. EPA Has Not Adequately Considered That in Many Areas of the U.S. Additional Reductions, Beyond Those Needed to Meet the Current Standard, May Not Be Achievable With Known Control Technology and Could Impose Ruinous Economic Consequences ............................................................................................ 47

J. The Agency’s Estimates of H ealth Benefits Are Highly Sensitive to Assumptions Regarding Background Levels......................................... 49

K. CASAC’s Conclusion That the Cu rrent Standard is Unjustified is Based on Unsupportable Assumptions................................................... 49

L. Tropospheric Ozone Protects Against UV-Induced Health Effects ........................................................................................................ 51

M. The Scientific Data and Precisi on of Ozone Measurement Monitors Does Not Support Specifying the Standard to the Third Decimal Place ........................................................................................................... 52

N. While EPA Should Retain the Cu rrent Standard, the Form of the Standard Should Be Changed to the Fifth Highest Daily Maximum 8-Hour Average Concentration.................................................................. 53

II. Comments on EPA’s Proposed Secondary Standard ........................................... 54

A. A Careful Review of the Existing Scientific Evidence Demonstrates That the Existing Secondary Standard is Requisite to Protect Public Welfare .......................................................................................... 54vi 1. All the issues and problems that led the Administrator in 1997 to reject the option of a seasonal ozone metric are still relevant ................................................................................ 54

2. There are problems, flaws and concerns with the SP analysis and vegetation risk assessment that preclude the establishment of a separate secondary standard to protect vegetation ............................................................................. 56

a. Extremes of background ozone concentrations were not considered .......................................................................... 56

b. The pattern of current W126 l evels suggests contributions from both man-made emissions and uncontrollable background ............................................................................. 56

c. EPA and CASAC relied on an inadequate model in recommending secondary standar ds that fall within the range of uncontrollable background ......................................... 57

d. There is no new data on veget ation effects suitable for establishing secondary standards ............................................ 58

e. The choice of an appropriate ozone metric to protect vegetation is difficult .............................................................. 58

f. The European experience with cumulative standards has been disappointing .............................................................. 59

g. The analysis used to discriminate between cumulative standards and the current 8-hour standard is flawed ....................................................................................... 59

h. The estimates of crop loss are substantially lower than those of the previous review ...................................................... 60

i. Studies of foliar injury do not support a cumulative
metric ....................................................................................... 60

j. CASAC made its recommendations based on the draft SP that contained errors overstating the magnitude of vegetation effects .................................................................... 61vii k. The recommended range for a cumulative standard needs to be adjusted upward .................................................... 61

l. The tools needed to implement a seasonal ozone standard are not in place .......................................................................... 62

III. Comments on EPA’s Regulatory Impact Analysis for the Agency’s Proposal to Revise the National Ambient Air Quality Standards for Ozone ..................................................................................................... 63

A. EPA’s Alleged Benefits from Lowering the Ozone NAAQS Are Not Likely to Occur ............................................................................. 63

1. EPA’s estimates of acute mort ality rely on weak epidemiology evidence and incorrect ly assume causality ................................. 64

2. The RIA incorrectly bases benefit estimates from reduced hospital admissions for resp iratory disease on selective studies .......................................................................................... 66

3. The data on school absences are weaker than noted in the proposed rule and are not reliable for purposes of estimating benefits ....................................................................... 67

4. EPA should include a lower bound of zero for the benefits of minor restricted activity days ................................................... 68

5. Given questions of PM speciation and other uncertainties, the lower bound of the ancillary PM 2.5 benefits should also be zero ................................................................................... 68

B. Even Though the Benefits Are Un certain, the Costs of Meeting a More Stringent Ozone Standard Will Occur and the EPA Analysis Likely Underestimates Those Costs...................................... 71

1. The RIA shows many existi ng nonattainment areas will not attain the current st andard with all known control technologies, even when applied to regions outside the nonattainment area .............................................................. 71viii 2. The RIA relies on unknown control technology to demonstrate attainment .............................................................. 72

3. The RIA correctly characterizes this extrapolation of costs from known to unknow n technologies as a highly speculative exercise. Actu al costs are likely to be significantly higher .................................................................... 721

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 

### THE ALLIANCE OF AUTOMO BILE MANUFACTURERS
COMMENTS ON EPA’S PROPOS AL TO REVISE NATIONAL AMBIENT AIR QUALITY ST ANDARDS FOR OZONE

72 Fed. Reg. 37, 818 (July 11, 2007)

These comments are being submitted by the Alliance of Automobile Manufacturers (Alliance) on behalf of its member companies in response to the U.S. Environmental Protection Agency’s (EPA or the Agency) Proposed Rulemaking for National Ambient Air Quality Standards for Ozone (Proposed Rule). The Allian ce is a trade association of nine car and light truck manufacturers including BMW Group, Chrysler LLC, Fo rd Motor Company, General Motors, Mazda, Mitsubishi Motors , Porsche, Toyota and Volkswage n. One out of every ten jobs in the United States is depende nt on the automotive industry.

The Alliance members share the concerns of our customers and the American public about this nation’s air quality a nd recognize the importa nce of assuring clean air that protects public health. While GDP, vehicle miles travel ed, and energy consumptions have all increased, our air is cleaner today than it was a generation ago and air quality is continuing to improve. According to EPA’s most recent air trends analysis, between 1970 and 2006, when gross domestic product increased 203 perc ent, vehicle miles traveled increased 177 perc ent and energy consumption increased 49 percent, total emission s of the six principal air pollutants dropped by 54 percent. 1 Investments and improvements in vehi cle technology and manufacturing processes are a major part of this success story. Today’s vehicles are 99 pe rcent cleaner than vehicles of the 1970s, which has resulted in dramatic reductions in smog-forming emissions. 2

Further, significant and additional emission re ductions will occur ov er the next 20 years as a result of already promulgated regulations for mobile sources. According to EPA’s own statistics, nitrogen oxide emissions from light du ty vehicles will be reduced by over 70 percent by 2030 as the result of the Tier II Vehicle and Gasoline Sulfur Program. 3 These reductions will help to reduce ozone con centrations across the c ountry, and the improvement s to air quality as a result of these reductions will occur regardless of whether the existing oz one standard is revised.

1 U.S. Environmental Protection Agency, Comparison of Growth and Emissions, 1970-2006, available at http://www.epa.gov/airtrends/images/compari son70.jpg (last visited Oct. 2, 2007).

2 Alliance of Automobile Ma nufacturers, Environment, available at http://www.autoalliance.org/environment/ (last visited Oct. 5, 2007).

3 http://www.epa.gov/tier2/faqs.htm

.2

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 EXECUTIVE SUMMARY

Under Section 109(a) of the Clean Air Act (CAA), 42 U.S.C. § 7409(a), EPA is required to set national ambient air quality standards (N AAQS) for criteria pollu tants. NAAQS include (a) a primary standard, which in the judgment of the Administrator, base d on air quality criteria and allowing for an “adequate margin of safety,” is “requisite” to protect the public health and (b) a secondary standard, which in the judgment of the Administrator, based on air quality criteria, is requisite to protec t the public welfare from any know n or anticipated adverse effects associated with the air pollutant. 4 EPA last reviewed and revi sed the ozone standard in 1997, when it promulgated the current 8-hour standard (0.08 ppm) to replace the previous, less stringent 1-hour standard (0.12 ppm) (referred to as the “1997 Review”). 5

The Alliance has carefully examined the evid ence in the Ozone Criteria Document (CD), EPA’s Staff Paper (SP) and in th is proposed rule. The current oz one standard is protective of public health with an adequate margin of safety and protective of public welfare in accordance with Section 109. There is no basis for EPA to revise the standa rd at this time.

These comments focus on the reasons why EPA’ s scientific justifi cation and legal grounds for lowering the existing ozone standard ar e unfounded and not supported by the relevant scientific body of literature and evidence pr oduced since the Agency’s 1997 Review.

1. The clinical and epidemiology evidence indi cate less risk from ozone exposure than
in 1997.

Although new clinical studies since 1996 have added to the available data, the fundamental understanding of effects at 0.08 ppm and above has not changed since the last review. In fact, the late st controlled human exposure stud ies shows there is less risk of lung function decrements and symptoms now than assumed in the 1997 Review. The data, that EPA has used to extend lung fu nction effects to lower concentrations, establishes that the response is non-linear in contrast to the li near assumption made previously. The public health significance of these potential risks has also declined. The percent of the population undergoing exposures of concern is significantly smaller in the current modeling than orig inally thought in 1996/1997. 6 The Second Draft SP relied upon this evidence in concluding that the es timates of lung function effects “are now appreciably lower than in the last review” 7 to support the view that the current standard protects the public health with an adequate ma rgin of safety. Nothing in the final SP or proposed rule contradicts this evidence. Th erefore, the new clinical studies do not provide a basis for lowering the NAAQs.

4 42 U.S.C. § 7409(b).

5 62 Fed. Reg. 38,855 (July 18, 1997).

6 U.S. Environmental Protection Agency, Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Inform ation, OAQPS Staff Paper - Second Draft , EPA-452/D-05-002, July 2006, at 5-71 (“Second Draft SP”).

7 Second Draft SP at 6-27.3

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 2. Time-series studies do not provide support for causality of effects but instead confirm significant uncertaintie s present in the 1997 Review.

Time-series epidemiology studies suffer from pr oblems associated with publication bias, model uncertainty, model selection issues, lack of adequate control for confounding variables, such as other pollu tants and weather, and exposur e misclassification arising out of the poor correlation between ambient monitors and personal exposure. In its June 2006 letter to the Administrator, EPA’s Clean Air Scientific Advisory Committee (CASAC) confirmed this view in evaluating mortalit y time-series studies, noting that “[b]ecause results of time-series studies implicate all of the criteria pollutants, findings of mortality time-series studies do not seem to allow us to confidently attribute observed effects specifically to individual pollutants.” 8

Analysis of time-series single-estimate results and more complete data sets, such as the National Morbidity and Mortality Air Po llution Study (NMMAPS), shows significant variability of positive and “n egative” responses unaccount ed for in the published literature or EPA’s analysis.

3. The evidence on premature mortality is too limited in nature and should not be relied upon in basing conclusions or estima ting health effects from exposure to

ozone.

In its June 2006 letter to the Administrato r, CASAC questioned whether the effect of individual pollutants, such as ozone, can be determined from time-series mortality studies because these studies implicate a ll of the criteria pollutants. 9 Furthermore, due to the significant potential for exposur e misclassification, the overall utility of the time-series mortality estimates is severely limited. The results from time-se ries studies of 95 individual cities, shown in Fi gure 7-17 of the CD, are inconsistent at best, ranging from strongly negative to strongly positive. 10 Such a wide range is not biologically plausible.

4. EPA’s risk estimate for mo rtality and certain respiratory endpoints fails to confirm
an increase risk from 1997.

EPA’s risk assessment fails to account for several major uncertainties, the correction of which would result in a significant reduction in the estimated risk. In estimating risk, EPA assumes causality. As discussed above, time-series studies have produced an implausibly wide range of asso ciations from strongly positive in some cities, to no effect in some cities to strongly negative (implyi ng protective effects) in some cities. In accordance with the recommendations of the National Academy of Sciences (NAS), the risk assessment should address this pivo tal uncertainty by incl uding a probabilistic

8 R. Henderson, CASAC Letter, EPA-CASAC-06-07, June 5, 2006 at 3 (“June 2006 CASAC Letter”).

9 June 2006 CASAC Letter at 3.

10 See U.S. Environmental Protection Agency, Air Quality Criteria for Ozone and Related Photochemical Oxidants , Vol. I of III, EPA 600/R-05/004aF, Feb. 2006, Figure 7-17 at 7-90 (“CD”).4

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 analysis of the major uncertainties, including the possibility the associations may not be causal. 11 Given the magnitude of the uncertainties and EPA’s failure to conduct an integrated uncertainty analysis, the current state of the scientific evidence supports retention of the current 8-hour standard.

5. The CAA does not require EPA to set standards that eliminate all risk.

EPA’s obligation under the CAA is to establis h standards that are “n either more nor less stringent than necessary” to protect public health. 12 This means establishing standards at a level that reduces risk sufficiently to protec t public health with an adequate margin of safety. A careful review of the scientific evidence shows that lowering the current ozone standard would result in controls unnecessary to protect public health.

6. Since EPA has not provided a reasonable analysis supporting its new judgment on what is requisite to protect public health or welfare, its actions could be found to be “arbitrary and capricious.”

In exercising his judgment to revise the existing NAAQS, the Administrator must provide a reasonable, scientific analysis for the ch ange. Specifically, EPA must explain why its earlier judgment regarding what is requisite to protect public health or welfare no longer governs. To reverse its position in the f ace of precedent that is not persuasively distinguished is arbitrary and capricious. 13 Given that EPA’s estim ate of health risks has declined and new information on the public he alth significance of these effects suggests less cause for concern, EPA cannot persuasive ly say why it must depart from its 1997 decision that the current standard is requisite to protect public health.

7. EPA has not correctly evaluated the potentia l for further risk reduction as a result of its proposed change to the cu rrent primary standard for ozone.

EPA has taken the largely unsupportable step of substituting mode led ozone background concentrations for ambient monitori ng based background. The new modeled concentrations, which suggest significantly lower concentrations of ozone background levels, suffer from several flaws, including a significant under-estima tion (by a factor of 2) of NOx emissions from soils. An i ndependent analysis shows that employing the more realistic ozone background levels used in the 1997 Review would eliminate over 95 percent of EPA’s estimated risk from exposur e to ozone without correcting for additional biases in EPA’s risk assessment.

11 National Research Council, Estimating the Public Health Benefits of Proposed Air Pollution Regulations, The National Academies Press, Washington, DC, September 2002.

12 Whitman v. American Trucking Ass’ns, Inc. , 531 U.S. 457, 473 (2001) (citation omitted).

13 Motor Vehicle Mfr.’s Ass’n v. State Farm Mut. Auto. Ins. Co. , 463 U.S. 29, 42 (1983) (presumption “against changes in current policy that are not ju stified by the rulemaking record”).5

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 8. EPA has not adequately considered that in many areas of the U.S., additional reductions beyond those needed to meet the current primary standard for ozone, may not be achievable with known cont rol technology and could impose ruinous economic consequences.

The situation in several nonattain ment areas is direr than implied by EPA in its proposed rule. Several nonattainment areas have recently submitted State Implementation Plans (SIPs) that fail to demonstrate attainment with the current standard, even when considering all curren tly known control technologies. A lthough the Administrator is not allowed to consider the costs of attaining th e standard, it is clea r that the CAA was not intended to impose ruinous c onditions on industry or the Am erican public. In some areas, the near elimination of all stationa ry and mobile source emissions would be required to meet the current st andard. Moreover, in making a policy judgment on what is requisite to protect public h ealth, the Administrator should consider the adverse impacts on health and quality of life from such stringent measures, particularly on the low income populations.

9. CASAC’s conclusion that the current primar y standard for ozone is unjustified and is based on unsupportable assumptions.

Based on the information presented to CASAC from the GEOS-CHEM model, CASAC was led to believe that ozone background leve ls never exceed 0.040 ppm. As a result, CASAC incorrectly assumed that a standard as low as 0.060 ppm is attainable and that, therefore, exposures of concern could be e ssentially eliminated. CASAC also erred in evaluating the risk of clinical effects. A lthough the Second Draft SP showed that the risk of lung function effects is lower than thought in 1997, the current CASAC panel appeared to believe that the APEX model us ed in the risk assessment for the clinical effects systematically under-predicted measured values. 14 In actuality, the model significantly overestimated the number of exposur es of concern as detailed elsewhere in these comments.

10. EPA’s estimate of non-mortality health be nefits, while small, still overestimates the potential benefit of meeting a lower primary standard

The benefits of a 0.070 ppm standard (or an y of the alternatives proposed by EPA) depend on highly questionable assumptions concerning mort ality causality. EPA’s Regulatory Impact Analysis (RIA) acknowledges that the direct benefits from ozone reduction itself are $190 million per year for the 0.070 ppm alternative if it is assumed that ozone does not cause premature mortality. 15 Given EPA’s estimate of the morbidity effects of ozone in the RIA are highly exa ggerated due to model selection issues and other factors discussed in these comments, a ll the alternative standards below the current

14 See, e.g., R. Henderson, CASAC Letter, EPA-CASAC-07-001, October 26, 2006, at 11.

15 U.S. Environmental Protection Agency, Regulatory Impact Analysis of the Proposed Revisions to the National Ambient Air Quality Standa rds for Ground-Level Ozone , EPA-452/R-07-008, July 2007, at 6-2 (“RIA”).6

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 standard are likely to achieve very little if any additional health benefits, even though achievement of such standards will require a massive investment and dramatic change in the quality of life for Americans.

11. A careful review of the existing scientific evidence demonstrates that the existing secondary standard for ozone is re quisite to protect public welfare.

EPA’s recommendation to use a new seasonal s econdary ozone standard does not address the uncertainties and limitations associated with the use of such a standard. Limitations include: (1) the lack of ozone monitoring data at vegetation he ight in rural areas; (2) the likelihood that extreme ozone background levels overlap with the ranges recommended for the secondary standard; and (3) the inability of the seasonal metric to account for the variable uptake of ozone by plants. The new data develo ped since 1997 does little to address these important uncertainties.

A new secondary standard also raises signif icant implementation issues. For instance, emission inventories (particularly for agricu ltural emissions) and modeling tools needed to implement a seasonal standard, particul arly in the Western United States, are not currently available. Establishing a secondary standard without these tools would impose an unreasonable implementation burden on states and local communities.7

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 DETAILED COMMENTS

Introduction

Section 109 of the Clean Air Act requires th e Administrator to set a primary national ambient air quality standard (NAAQS), the atta inment and maintenance of which in the judgment of the Administrator are requisite to prot ect the public health w ith an adequate margin of safety. EPA’s obligation under the CAA is to establish standards that are “neither more nor less stringent than necessary” to protect public health. This m eans establishing standards at a level that reduces risk sufficiently to protect public health with an adequate margin of safety. Lowering the current ozone standa rd would result in controls unnecessary to protect public health.

A careful review of the scien tific evidence shows that EPA’ s understanding of the potential risks from exposure to ozone at the current st andard remains largely the same as in 1997, and that the actual risk from exposure to levels be low the standard, based on clinical evidence, may now be lower than what was asse ssed in 1997. In addition, it is clear from the Second Draft of EPA’s Staff Paper that the percent of the po pulation undergoing expos ures of concern is significantly smaller in the curre nt modeling than originally t hought in 1997. As EPA states in the preamble, its task under Sec tion 109 is to “establish standard s that are neither more nor less stringent than necessary for these purposes.” 16 Lowering the standard in light of the 1997 determination would result in controls that w ould be unnecessary to protect public health.

Since EPA has not provided a reasonable scie ntific analysis suppor ting its new judgment on what is requisite to protect publ ic health or welfare, its actions could be found to be “arbitrary and capricious.” In exercising his judgment to revise the existing NAAQS, the Administrator must provide a reasonable, scientific analysis for the change. Specifically, EPA must explain why its earlier judgment regarding what is requis ite to protect public health or welfare no longer governs. To reverse its position in the face of preced ent that is not persuasively distinguished is arbitrary and capricious.

The weight of the science suppor ts retention of the current oz one standard as requisite to protect public health and welfare. There is nothi ng in the science that deviates from EPA’s 1997 analysis, and EPA failed to adequa tely explain its change of pos ition. A careful review of the scientific studies EPA relies on to justify a lower standard illustrates that EPA’s current estimates of risk are inflated and unrelia ble. EPA’s own Regulatory Imp act Analysis (RIA) shows that many areas of the country today are struggling to meet the current standard and that many more areas will be unable to attain a tighter standard with known te chnology. Requiring areas to meet a more stringent standard would impose “ruinous ” conditions on the Ameri can public contrary to the intentions of the CAA.

16 72 Fed. Reg. 37,818, 37,820 (July 11, 2007).8

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 As these comments will show, the state of the science indicates that the current standard is requisite to protect public health and welf are, and that EPA has not provided a reasonable explanation to deviate from its finding in 1997.

I. Comments on EPA’s Proposal to Revi se the Primary Standard for Ozone.

EPA proposes to revise the primary NAAQS for ozone by reducing the current 8-hour standard of 0.08 ppm to a level within the range of 0.070 to 0.075 ppm. In addition, EPA seeks comments on alternative levels, down to 0.060 ppm, and up to retaining the current standard. 17

An exhaustive review of the administrativ e record and the underlying studies on which the proposed revisions are based shows that a revision of the current 8-hour ozone NAAQS cannot be justified. Any tightening of the current standard would not meet the statutory test -- that the “attainment and mainte nance of [such standard], ... allowing an adequate margin of safety, are requisite to protect the public health.” CAA at §109(b)(1). To be “requisite to protect the public health,” the standard must be “n ot lower or higher th an is necessary.” Whitman v. American Trucking Associations , 531 U.S. 457, 476 (2001). As the Administrator found in 1997, the current standard meets that test. While there have been many additional studies since that time, as demonstrated in the detailed comments below

, those studies do not show that the risk from ozone is any greater than was recognized in the prev ious rulemaking, and the level of uncertainty over the existence of those risks has increased. EPA should retain the existing primary ambient NAAQS for ozone.

A. The Clinical and Epidemiology Eviden ce Indicate Less Risk from Ozone Exposure than in 1997.

1. The risk of respiratory effects is substantially reduced from what was estimated in the 1997 Review.

EPA is correct in concluding that contro lled human exposure studies offer the best information on ozone effects. Although there are a wide range of epidem iological studies that report associations of ozone with health endpoints, the proposed rule notes that the epidemiological studies are not th emselves direct evidence of a causal link between exposure to ozone and the occurrence of the effects. 18

A careful examination of the clinical data (including the new data) shows that there is less risk of lung function decrements and sympto ms than was assumed in the 1997 review. Key findings from the clinical data include the following:

The data extending lung function effects to lower concentrations establishes that the response is non-linear in contrast to the linear assumption made in the previous review. The preamble notes that the logistic form provides a very good fit to th e combined data set used in

17 72 Fed.Reg. at 37,818 (July 11, 2007).

18 72 Fed. Reg. at 37,879.9

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 the current Risk Assessment. 19 Although the final Staff Paper (SP) does not show a direct comparison between the dose-re sponse assumed in 1996 and th e current dose-response, the Second Draft SP did include such a comparison in Figure 5-2 a., b., and c. The Figure clearly shows that the response rates for FEV 1 decrements >10%, >15%, and >20% are lower at all concentrations below the current st andard with the logistic form. 20 This means that, for a given ozone exposure below the current standard, the risk of lung func tion decrements is now lower than thought in the previous review.

Although there are many differences between the 1996 and 2007 clinical risk assessment methodologies, it is clear from the Second Draf t SP that the percent of the population undergoing exposures of concern is significantly smaller in the current modeling than originally thought in 1996/97. The Second Draft SP, which was the first draft that included staff’s recommendations for the level of the standard, used the fact th at the estimates of lung function effects “are now appreciably lower than in the last review” to su pport the view that the cu rrent standard protects the public health with an adequate margin of safety.

Finally, although respiratory symptoms in h ealthy children were estimated in the 1996 review, that endpoint was not incl uded in the current review si nce a number of field studies failed to find such effects.

2. The clinical data do not supp ort the reversal of EPA’s 1997 determination that the current standard is requisite to protect the public health with an ade quate margin of safety.

EPA’s conclusions from the 1997 Review are unaltered by more recent clinical studies and, thus, do not support a revised determinatio n that the current 8-hour standard is no longer sufficient to protect public health wi th an adequate margin of safety.

The proposed rule notes that , in controlled human exposures , the first effects on the performance of lung function test s occur at 0.50 ppm in sedentary individuals. EPA focuses on
FEV 1 , the volume of air expired in the first se cond during maximal expiratory effort. With increased levels of physical activity and breat hing rate, the threshold for the first effects decreases. However, the thresholds for the first effects in controll ed studies are still considerably above the vast bulk of personal exposures of the general population. During the 1997 Review, EPA staff concluded that the lowe st range within which 1- to 3- hour exposures to ozone at heavy exertion produce group mean sta tistically significant lung func tion decrements is 0.12 to 0.16

ppm. 21 They concluded that the lowe st range for 6- to 8-hour expos ures at moderate exertion is 0.08 to 0.12 ppm. 22 The exercise utilized in the 6- to 8-hour controlled exposure studies was intended to simulate work performed during a day of heavy to severe manual labor by outdoor

19 72 Fed. Reg. at 37,858.

20 Second Draft SP, Figure 5-2 a., b., c. at 5-17. col. 2.

21 U.S. Environmental Protection Agency, Review of National Ambient Air Quality Standards for Ozone Assessment of Scientific and Technical Information, OAQPS Staff Paper , EPA-452/R-96-007, June 1996, at 49-150. (“1996 Staff Paper”)

22 1996 Staff Paper at 150.10

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 laborers. 23 Although the ventilation rate (40 L/min) is described by EPA as “moderate exercise,” activity maintained at this level for 6 to 8 hours has to be considered “heavy” or “strenuous work or play.” The staff conclusions regarding lowest effect levels fo r various respiratory endpoints in the current review are unchanged from the previous review w ith one exception, which is discussed below.

More importantly, in addition to establis hing the presence or absence of physiological changes, the question of the public health signi ficance of any measured changes needs to be addressed. In the previous review, there was considerable discussion of this question and a framework for evaluating the adversity of repo rted changes was developed with one set of criteria for healthy individuals and another for individuals with compromised respiratory systems. The two frameworks for evaluating a dversity in the previous review are included, unchanged, in the current SP.

The Criteria Document (CD) acknowledges that there is a neurally-mediated mechanism that is responsible for the lung function decrements and symptoms s een in the clinical studies. A body of studies now shows that the first effects of ozone are caused by reflex responses of vagal nerve receptors. This response is the body’s reflexiv e reaction to the presence of an irritant gas and is unrelated to sensations of discomfort. Such a risk woul d be considered both safe and tolerable. The CD acknowledges that these eff ects are transient, of a reflex nature, and reversible. 24

In the previous review, CASAC and staff de termined that single, acute moderate lung function responses in healthy indi viduals should not be considered adverse. For asthmatics, staff previously concluded, based on discussions with medical experts, that single ozone exposures that resulted in moderate responses were not lik ely to interfere with nor mal activity nor would it result in increased frequency of medication or the use of additional medications. There is no scientific basis for chan ging these conclusions in the current review. In fact, in the proposed rule, the Administrator concur s noting that “[w]hile some experts would judge single occurrences of moderate responses to be a ‘nuisa nce,’ especially for healthy individuals, a more general consensus view of the a dversity of such moderate respons es emerges as the frequency of occurrence increases.” 25 The concern over multiple occurrences arises not because of established effects but because of the potential fo r it leading to adverse consequences. However, there has been little or no discussion in the curr ent review of the number of occurrences that should be considered adverse or of the public h ealth significance of multiple occurrences, given the reflex mechanism that is re sponsible for the transient FEV 1 changes.

Although new clinical studies since 1996 have added to the available data, the fundamental understanding of effects at 0.08 ppm and above has not changed since the last review. In 1996, EPA concluded that a wide array of health effects were attributed to short-term

23 W. McDonnell, H. Kehrl, S. Abdul-Salaam, P. Ives, L. Folinsbee, R. Devlin, J. O’Neil and D. Horstman, Respiratory response of humans expose d to low levels of ozone for 6.6 hours , Arch. Environ. Health, 46, 145-150 (1991).

24 CD at 6-44 to 6-45.

25 72 Fed. Reg. at 37,850.11

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 (1 to 3 hrs.), prolonged (6 to 8 hrs.) and long-te rm exposure to ozone at levels as low as 0.08 ppm. The 1997 Review found acute health effect s induced by short-term exposures to ozone concentrations as low as 0.12 ppm, occur generall y while subjects are engaged in heavy exercise. These effects include pulmonary function responses, transient re spiratory sympto ms, effects on exercise performance, increased airway responsiv eness, increased susceptibility to respiratory infection and transient pulmonary inflammation. Similar health effects in the 1997 Review were observed following prolonged exposu res to ozone at concentrations as low as 0.08 ppm and at lower levels of exercise. 26 EPA noted that some of the st udies reporting effects at 0.08 ppm included Follinsbee et al. (1991), 1994, Gong et al. (1986), Hazucha et al. (1992), Horstman et al. (1990, 1995), Horvath et al. (1991), Koren et al. (1988,1989 and 1991), Lin et al. (1994) and McDonnell et al. (1991).

However, new data (Adams 2006) extended th e database on lung f unction effects down to 0.06 ppm and 0.04 ppm for 6 to 8 hours with moderate exercise. 27 The interpretation of the latest data is controversial. In the Second Draf t SP, EPA indicated that the lowest ozone effect level for pulmonary function decrements and in creased respiratory symptoms was 0.08 ppm for 6.6 hours, 28 but in the final SP, this was lo wered to 0.06 ppm for group comparisons 29 and 0.04 ppm for individuals. 30 The change occurred for several reasons. First, EPA adjusted the Adams 2006 study’s results based on the assumpti on that the performance on lung function tests generally improves after exposure to the filtered ai r control. In addition, EPA also re-analyzed the data with a different statistical test. W ith these changes EPA drew completely different conclusions from those of the study’s author, with regard to possible st atistical significance of group mean results. The author of the origin al study has subsequen tly objected to the conclusions of this re-analysis. EPA also in appropriately relied on the results in individual subjects in drawing their conclusions.

It is important to note that the group mean decrement, even with the adjustment for the filtered air response was less than 3 percent, whic h is within the 3 to 5 percent range of normal measurement variability for an individual and s ubstantially less than the 10 to 20 percent range discussed as adverse lung func tion decrements. For example, the range of individual FEV 1 changes in the filtered air group in these studies was -6.0 to 12.4 percent. In fact, decrements of 3 percent or less are noted in the SP as having no interference with normal activity for either healthy persons or persons with impaired respir atory systems. Given th at the observed effects from the Adams 2006 study are not medically signi ficant, the debate over whether the study demonstrates a statistically signif icant effect at specific ozone expos ure levels is not meaningful. For this reason, the Administrator cannot rely on the Adams 2006 study as evidence to support a

26 1996 Staff Paper at 24; 62 Fed. Reg. at 38,859.

27 W. Adams, 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, 18, 127-136 (2006).

28 Second Draft SP, Table 3-4, at 3-78.

29 U.S. Environmental Protection Agency, Review of National Ambient Air Qu ality Standards for Ozone: Policy Assessment of Scientific and Technical Information, OAQPS Staff Paper , EPA-452/R-07-007, July 2007, Table 3-4, at 3-84 (“SP”).

30 SP at 3-1.12

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 conclusion of significant public health effects below the current standard when the effects observed are not considered medically significant.

3. EPA’s risk assessment based on the clinical studies does not support the conclusion that a tightening of the standard is re quisite to protect the public health.

EPA’s interpretation of the ri sks based on clinical studies is flawed and does not support the conclusion that a more stri ngent standard is needed.

The exposure/exertion protocols used in the human clinical studies do not mimic typical human behavior so the results must be mapped onto realis tic exposure/activity scenarios to determine the risk. The chance of experiencing an exposure of con cern requires that a person be outside at the location of the high ozone, at th e time of peak ozone and exercising heavily. During the 1996/1997 review, EPA staff undertook an extensive exposure and risk assessment with input from CASAC. To estimate the ris k, staff used the output of a probabilistic exposure model together with concentra tion-response functions derived fr om the clinical studies. The conservative analysis, documented in the 1996 St aff Paper, assumed lung function decrements started at 0.04 ppm, assumed no attenuation of e ffects, assumed that children experienced the same level of symptoms as adul ts (available data s uggests otherwise), i gnored smoking status that would attenuate responses in outdoor workers, and used human time/activity and exertion data from California as well as other locations. The EPA analysis also used an algorithm to assign ventilation rates based on individuals who exercised regul arly and were motivated to reach a high ventilation rate. As a result, the 1996 Staff Paper acknowledged 31 that the analysis allowed more high ventilation ra tes (hence greater risk) than would actually occur in the populations of interest -- outdoor workers, outdoor children, etc.

The 1996 exposure and risk assessment dem onstrated that there will be a minimal number of days of ozone-related respiratory e ffects with 8-hour concentrations up to 0.09 ppm and employing statistical forms allowing up to fi ve exceedances per year. The risk analysis based on human clinical studies was one of the ma jor factors in the Administrator’s choice of the current ozone standard. While the primary standard is required to allow for an adequate margin of safety, the extreme value form of the curren t 8-hour standard, in itse lf, adds a substantial margin of safety in that it drastically lim its the number of poten tial repeat exposures.

The current review includes an update to the exposure and risk assessment. The APEX model developed estimates of the number of all school age children and asthmatic school age children exposed one or more times a year to various 8-hour ozone concentrations (0.06 ppm, 0.07 ppm, and 0.08 ppm) while undergoing moderate exer tion in a number of urban areas. These exposure metrics are discussed as benchmark “expos ures of concern.” The proposal notes that only a subset of the individuals in these grou ps would actually be expected to experience effects. 32 The benchmark metrics were evaluated fo r both “as-is” ozone concentrations for the

31 1996 Staff Paper at 102.

32 72 Fed. Reg. at 37,855.13

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 years 2002 to 2004 and then for the ozone concen trations estimated to occur upon meeting alternative standards. The exposures from th e APEX model were then used with the doseresponse functions for FEV 1 changes to estimate the number of moderate or greater lung function responses in the same groups for both the “as-is” air quality and that estimated upon attainment of various alterna tive standards.

The proposed rule notes that the Administra tor considered the number of persons exposed at or above the 0.07 ppm benchmar k and the clinical risk estimates along with other factors in evaluating the adequacy of the current standard. 33 In fact, the proposed rule notes specifically that the Administrator focused on the risks remain ing upon just meeting the current standard in considering the adequacy of that standard. 34 In addition, the Administrator relied significantly on the exposure and risk assess ment results in choosing the ra nge of 0.070 to 0.075 ppm for the proposed revised primary standard. To the extent that there are significant biases in the exposure and risk assessment, the interpretation of the public health protection afforded by either the current standard or various alternatives would change.

There are at least five ways in which the cl inical exposure and risk assessment is biased, overstating the exposures and risk s that would accompany any of the alternative standards under consideration. Specifically, there are three ways that the APEX model used in the current risk assessment overestimates the number of occurren ces of elevated 8-hour ozone exposures during strenuous work or play and two ways in whic h the Risk Assessment (R A) overestimates the benefits of alternative standa rds. The five areas are:

1. The CD acknowledges that ozone exposure is lower at “person” height compared to “measurement” height (3-15 meters). 35 For example, Wisbeth et al. 36 measured the increment between ozone at 2 and 10 meters and reported an average 13 percent difference. In addition to the height differential, ozone mon itors are also sited in open areas removed from sources so as to capture the highest ozone concentrations expected in an area. Since downwind sites are usually th e design value sites, they will dominate the upper tail of the ozone distribution and yet ma y not reflect the overa ll outdoor exposures in the vicinity of the site. If people spend time outdoors in closer proximity to streets or in areas with more surface area (buildings, etc. ) to quench ozone, their exposures will be below that measured at the monitor. The APEX model assumes that whatever ozone is interpolated from the monitor measurement is the actual ozone exposure in the outdoorsother microenvironment. The Langstaff Memo randum acknowledges the issue of vertical variation in ozone but indicates that the Agen cy does not plan to address it due to a lack of data. 37 This difference was corrected in the vegetation risk assessment but not in the

33 72 Fed. Reg. at 37,871.

34 72 Fed. Reg. at 37,871.

35 See CD at 3-15, AX3-190-91.

36 A. Wisbeth, G. Meiners, T. Johnson, and W. Ollison, Effect of monitor probe height on measured ozone
concentration , Paper No. 96-RA111.02, presented at the 89th Annual Meeting of the Air & Waste Management Association, Nashville, TN, June 1996.

37 J. Langstaff, Technical Memorandum, Analysis of Uncertainty in Ozone Population Exposure Modeling , Jan. 2007, at 21-22 (“Langstaff Memorandum”) .14

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 human risk assessment. In the vegetation risk, the metric summing concentrations of 0.06 ppm and higher was halved with a 10 pe rcent vertical correct ion. By analogy, a vertical correction in the human risk assessm ent would likely halve the number of human exposures of concern at ground level. Because this effect would correct a bias in the exposure calculations, it is particularly importa nt to evaluate and include it in the risk assessment before the final rule.

2. The upper tail of the distribution of breathing rates -- equivalent ve ntilation rates (EVR) -- is particularly important because it is a cr itical factor in dete rmining the number of exposures of concern. EPA assumes that all exposures between 13 and 27 EVR respond as though they were at 20 EVR, substantially overestima ting the risk since there are many more 8-hour occurrences of oz one at 13 EVR than at 20 and many more at 20 EVR than at 27. This results in an overestimation of the number of exposures of concern. The 1996 CD showed that 1- to 2-hour ozone re sponses vary with EVR and Ollison has shown that the 8-hour responses in the Folinsbee/Horstman data do too. 38 Thus, the doseresponse curve varies with EVR. The distribu tion of exposures also varies with EVR. We expect many more 8-hour occurrences of ozone exposures at 13 EVR than at 20 and many more at 20 EVR than at 27. Thus, the approximation that all exposures between 13 and 27 EVR respond as though they were at 20 EVR substantially overestimates the risk.

Since the model calculates EVR to a much fi ner scale, the distribution of EVR should be presented in the risk assessment and dose- response curves should be developed as a function of EVR to avoid the ov erestimation of risk. At a mi nimum, this issue should be evaluated in a sensitivity analysis. The Langstaff Memorandum indicates that the EVR cutpoints input to APEX are selected for the risk calculations and are not considered as uncertain for the purposes of the uncertainty analysis. 39 However, it would be simple to break the wide EVR range used for the risk ca lculations into a numbe r of smaller bins to test the hypothesis that the us e of such a wide EVR range bi ases the overall result. In addition, the American Petroleum Institut e (API) has provided EPA with a dynamic statistical model that can be implemented in APEX and provide more highly refined
FEV 1 decrements. 40 The sensitivity of APEX predic tions to the use of the API model should be evaluated prior to th e issuance of the final rule.

3. The model predicts more elevated ventilati on rate occurrences than observed in real world data. Langstaff acknowledged that the “values produced by the ventilation rate algorithm may exhibit an exce ssive degree of variability.” 41 The final sensitivity analysis for APEX includes a comparison of predicted ve ntilation rates with mean values in the literature, but the upper tails of the distribution which impact the risk estimates were not

38 American Petroleum Institute Comments on EPA’s Dec. 13, 1996 Proposed Ozone Rule, Appendix A.

39 Draft Langstaff Memorandum at 43.

40 Memorandum from Ted Johnson, TRJ Environmental, to John Langstaff and Harvey Richmond, U.S. EPA, An algorithm for APEX that estimates one-minute ozone-induced FEV 1 decrements , (July 31, 2006) (included as attachment to Memorandum from Will Ollison, API Energy , to Karen Martin, U.S. EP A (Aug. 29, 2006) (EPA-HQOAR-2005-0172-0037.1)).

41 Draft Langstaff Memorandum at 42.15

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 compared. 42 This is an important oversight beca use the upper percentiles of ventilation rate are responsible for the exposures that ca use the perceived risk. In the comparison of the APEX modeled values with the m easured ventilation rates from Brochu et al. 2006, 43 the model over-predicted mean daily ventilation rates for persons below age 11 and over age 40. More importantly, the model had a much higher standard deviation at all ages. This suggests that the upper percentiles of ve ntilation rates in the m odel are substantially above those measured in a database of over 30,000 person-days from a cohort of over 2200 free-living individuals between the ages of 3 and 96. This is pa rticularly important since the comparison was not available to CASAC before the panel provided its recommendations. A detailed analysis of th e upper tails of the distribution of predicted and measured ventilation rates must be carri ed out before the final rule is issued.

The following Figure 1 shows that the APEX model EPA uses in the risk assessment significantly overestimates the breathing rates of male children, particularly for the upper tails of the distributi on that are responsible for the expos ures of concern discussed in the proposed rule. The data underlying these di stributions (means and standard deviations) come from Table 25 in the 2007 Langstaff Me morandum on uncertainty in the exposure model. In fact, of the 16 comparisons in Table 25, for eight age groupings each of males and females, 15 had substantially higher modeled ventilation rates compared to the data reported by Brochu, et al. 2006 at the upper end of the distribution.

42 J. Langstaff, Technical Memorandum, Analysis of Uncertainty in Ozone Population Exposure Modeling , Jan. 31, 2007 at 52 (“2007 Langstaff Memorandum”) (EPA-HQ-OAR-2005-0172-0174).

43 See P. Brochu, J. Ducre-R obitaille, and J. Brodeur, Physiological daily inhalation rates for free-living individualsaged 2.6 months to 96 years based on doubly labeled water measurements: comparison with time-activityventilation and metabolic energy conversion estimates , Int. J. Hum. Ecol. Risk. Asses., 12, 736-761 (2006).16

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 Figure 1: Comparison of Measured vs. Modeled Daily Ventilation Rates for 7- to 10-Year Old Boys

4. The EPA risk assessment uses the current distribution of ozone concentrations as a baseline input. To estimate risk associated with a given standard, the model “rolls back” ozone levels to the given standard. Ther e are several problems with the rollback methodology EPA used. It is arbitrary and does not mimic the changes that will occur as emissions are reduced and man-made ozone is reduced. Importantly, EPA ignores background when rolling back the distribution of ozone concentrations at individual sites.

Currently, NOx emissions suppress ozone a significant portion of the time via the NO +
O 3 reaction. As ozone precursor emissions are reduced, there is a reduction in the highest daily 8-hour ozone concentrations but lower oz one concentrations actually increase. The CD notes this behavior ( see CD at 3-32 to 3-35) referring to Figures 3-17 and 3-18 which show the year-to-year trends in the distri bution of mean daily 8-hour averages and the
95 th percentile of daily 8-hour averages across the country. The text indicates that the highest ozone concentrations de creased over the past 15 years, but there has been little change in the middle of the di stribution and a slight increase in ozone concentrations near the bottom of the distribution because of reduced titration of ozone with NO in response to reductions of NOx emissions. EPA’ s rollback misses the increase in ozone concentrations near the bottom of the distribu tion as the man-made in fluence on ozone is decreased. EPA’s rollback overestimates the change in ozone at mid- and low 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%

0 5 10 15 20 25 Ventilation Rate (m3/day) Measured

Modeled

Male Ventilation Rate Distributions, 7 to < 11 Years Old

Air Improvement Resource, Inc.17

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 concentrations and, thereby, overestimates the benefits of alternat ive standards. The rollback should be applied to the man-made portion of ozone not th e entire distribution.

5. The background ozone assumed in the risk assessment is too low. Since the risk assessment subtracts the risk from background, a higher background will result in a lower risk from attaining the current standard. As demonstrated elsewhere in these comments, the Agency’s approach to estimating backgr ound is flawed. As in previous ozone reviews, both the mean and extremes of b ackground need to be evaluated in order to properly account for the ozone that is not cont rollable through control of U.S. man-made emissions.

Corrections to the exposure and risk a ssessment for these five major biases should substantially increase the health benefits and re duce the potential risk asso ciated with attaining the current standard. The corrected risk assessme nt would confirm that th e current standard is protective of public health in accordance with the requirements of Section 109 of the CAA.

Even with significant overestimates of the numb er of exposures associated with exercise, the APEX results presented in the SP demonstrate that the current standard limits the number of persons and person-occurrences of ozone exposures to 0.08, 0.07, and 0.06 ppm for 8-hours with moderate exertion (strenuous work or play). Co rrecting major biases would significantly reduce the estimates further and confirm the protectiven ess of the current standard and the unlikelihood of achieving additional pub lic health benefits from lowering the standard.

B. Time-Series Studies Do Not Provide Support for Causality of Effects But Instead Confirm Significant Uncert ainties Present in the 1997 Review.

1. In interpreting the epidemiologi cal evidence, EPA downplays the major new findings concerning uncertainty due to model selection
issues.
Model selection uncertainty relates to c onfounding of air polluta nt associations by temporal trends, weather and co-pollutants. EPA acknowledges that the uncertainties in the estimates of ozone effects (or those of any ot her pollutant) are understated by consideration of the statistical uncertainty of the fitted model alone. Much more uncertainty arises from the lack of information regarding the choice of appropr iate models for adjusting confounding by other covariates, and the choice of appropria te lag structures. As Lumley and Sheppard (2003) point out:

Estimation of very weak associations in the presence of measurement error and strong confounding is inherently challengi ng. In this si tuation, prudent epidemiologists should recognize that resi dual bias can dominate their results. Because the possible mechanisms of acti on and their latencies are uncertain, the biologically correct models are unknown. This model selection problem is18

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 exacerbated by the common practice of screening multiple analyses and then selectively reporting only a few important results. 44

Others have also pointed out th e critical importance of model c hoice, particularly when effect estimates are small. For example, Smith et al. caution:

From a statistical point of view, the co mmon epidemiological practice of choosing variables (including lagged va riables, co-pollutants, etc.) that maximize the resulting effect estimates is a dangerous approach to model selection, particularly when the effect estimates are cl ose to 0 (i.e., RR close to 1). 45

Smith et al. note that Lumley and Sheppard (2000) 46 showed that the effectof choosing lags in this fashion has a bias which is of the same order of magnitude as the relative risk being estimated.

The revised analyses necessitated by the probl ems with the commonly used software for time-series analyses clearly show that methods used for control ling temporal trends and weather can profoundly affect the results. To make matte rs worse, there appears to be no objective statistical test to determine whether these factor s have been adequately controlled. The Health Effects Institute Expert Panel 47 for the re-analysis states, “Ritov and Bickel (1990) 48 have shown, however, that for any continuous va riable, no strictly data-based ( i.e., statistical) method can exist by which to choose a sufficient number of de grees of freedom to insure that the amount of residual confounding due to that vari able is small. This means th at no matter what statistical method one uses to select the degrees of freedom, it is always logically possible that even if the true effect of pollution is null, the estimated effe ct is far from null due to confounding bias.” The expert panel concluded further, “Neither the appropriate degr ee of control for time, nor the appropriate specification of the eff ects of weather, has been determined for time-series analyses”. In other words, it is impossible to adjust tem poral trends without accu rate information from external sources regarding the appropriate degrees of freedom to use. Such information simply does not exist.

44 T. Lumley and L. Sheppard, Time-series analyses of air pollution and health: straining at gnats and swallowing camels? Epidemiology, 14, 13-14, 2003.

45 R. Smith, P. Guttorp, L. Sheppard, T. Lumley and N. Ishikawa, Comments on the Criteria Document for Particulate Matter Air Pollution , Northwest Research Center for Statistic s and the Environment Technical Report Series No. 66, July 2001.

46 T. Lumley and L. Sheppard, Assessing seasonal confounding and model selection bias in air pollution epidemiology using positive and negative control analyses , Environmetrics, 11, 705-717 (2000).

47 Health Effects Institute, Special Report: Revised Analyses of Time-Series Studies of Air Pollution and Health

, Health Effects Institute, Cambridge, Massachusetts, at 267, 269 (2003).

48 Y. Ritov and P. Bickel, Achieving information bounds in non- and semi-parametric models , Ann. Stat., 18, 925- 938 (1990).19

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 With regard to uncertainty due to mo del selection, the Koop and Tole 2004 49 conclude:

Point estimates of the effect of numer ous air pollutants all tend to be positive, albeit small. However, when model uncer tainty is accounted for in the analysis, measures of uncertainty associated with these point estimates became very large. Indeed they became so large that the hypothe sis that air pollution has no effect on mortality is not implausible. On the ba sis of these results, we recommend against the use of point estimates from time-series data to set regulatory standards for air pollution exposure.

EPA has failed to adequately account for the significance of model uncertainty in either its qualitative or quantita tive assessment of the health effects from exposure to ozone. Given that the small positive results from time-series studies may reflect residual bias of the models due to weather, temporal or other unaccounted confounding factors, EPA cannot and should not draw conclusions on causality from these studies.

2. In interpreting the epidemiologi cal studies, EPA relies on single estimate and single-site analyses, a nd fails to address the effect of publication bias.

The SP and proposed rule discuss three new meta-ana lyses of ozone mortality associations and point out that they come to similar conclusions. When these studies were published, they were accompanied by two commentaries referenced in the CD but not the SP or proposed rule. The commentary by Good man is particular ly insightful. 50 It notes that the implications of the EPA-sponsored exercise of funding three separate meta-analyses “go far beyond the question of the ozone mortality effect .” He cautions that “depending on published single-estimate, single-site analyses are an invitation to bias.” He notes that “the most plausible explanation is the one suggested by the authors, that investigators tend to report, if not believe, the analysis that produces the strongest signal; and in each single-site analysis, there are innumerable model choices that affect the es timated strength of that signal.” Although the proposed rule mentions the issu e of publication bias, it is discounted by a sserting that ozonemortality associations remained after accounting for the bias. However, the current methods for estimating and correcting publicatio n bias are only partial and incomplete. For example, the current method of plotting the effect size versus the standard error (refe rred to as a funnel plot) and using the trim and fill method to provide a sy mmetrical plot, resulted in the order of a 10 percent reduction in effect size in the Ito et al

. 51 meta-analysis, but Bell et al. 52 and Goodman noted factors of three or more reduction in effect size comparing the published single-city studies with the comprehensive NMMAPS data set. The reasons for the discrepancy is likely the result

49 G. Koop and L. Tole, Measuring the Health Effects of Air Pollution: to What Extent Can We Really Say that People are Dying from Bad Air , J. of Environmental Economics and Management, 47, 30-54. (2004).

50 S. Goodman, The Methodologic Ozone Effect , Epidemiology, 16: 430-435 (2005).

51 K. Ito, S. de Leon, and M. Lippmann, Associations between ozone and daily mortality , Epidemiology, 16: 446- 457 (2005).

52 M. Bell, F. Dominici, and J. Samet, A meta-analysis of time series of ozone and mortality with comparison to the National Morbidity, Mortality, and Air Pollution Study , Epidemiology, 16: 434-445 (2005).20

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 of many non-random model select ion choices in the conduct of the study in addition to the nonrandom choice of whether to publish.

3. Analysis of more complete data sets, such as NMMAPS, suggests significant variability of posi tive and “negative” responses unaccounted for in the published lit erature or in EPA’s analysis.

While there are some inverse or negative air pollution associati ons reported in the literature (implying an unlikely protective effect from exposure to ozone), the NMMAPS study shows that there are many more “negative” associati ons in the data than in the literature. When the statistical issues with the General Additive Model (GAM) were raised, Ito 53 systematically re-analyzed the 1220 separate air pollution mortal ity and morbidity asso ciations that were included in the original Lippmann et al. 2000 study of Detroit, comp aring the results using the General Linear Model (GLM) to those with the suspect GAM. As shown in Figure 2, there was a wide range of negative and positive excess risk s (associations) in Detroit when a large number of pollutants, lags and morbidity and mortality endpoints were considered. All the combinations of pollutant, lag and health outcome evaluated in the original Lippmann study were considered plausible candidates for air pollution health effects. Ito showed in separate figures that the wide range of associations occurred for each pollu tant, including ozone. Al though the focus in the original Lippmann study, as it is in almost all the published literature, was on the positive associations, Ito’s plot shows that there are many negative associations in the data.

Figure 2: Comparison of Generalized Additive Model With
Generalized Linear Model 54

53 K. Ito, Associations of Particulate Matter Components with Daily Mortality and Morbidity in Detroit, Michigan

, in Health Effects Institute, Special Report: Revised Anal yses of Time-Series Studies of Air Pollution and Health, May 5, 2003, at 143-156.

54 Id.21

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 Although there may be somewhat more positive associations than negative associations, there is so much noise or variability in the data that identifying which positive associations may be real health effects and which are not is be yond the capability of current methods. Thus, timeseries epidemiology of air pollution associations is a very blunt tool. CASAC raised this issue in a June 2006 letter to th e Administrator, noting that “becau se results of time-series studies implicate all of the criteria pollutants, findings of mortality time-series studies do not seem to allow us to confidently attribute observed e ffects specifically to individual pollutants.” 55 Further, due mainly to exposure misclassification concerns, they questioned the util ity of the time-series mortality estimates.

If all positive associations (or excess risks) ar e assumed or concluded to be health effects then all negative associations s hould be considered health bene fits due to ozone or other air pollutants. Since no one believes the observed nega tive associations are pr oof that air pollutants actually provide health benefits on a day-to-d ay basis, the assumption that all positive associations are health effects is also not plau sible. For example, the various ozone/mortality associations in 95 U.S. cities shown in Figure 7-17 of the CD at 7-90 (ranging from - 6 to + 10% per 0.02 ppm increase in 24-hr. average ozone in th e previous week) would imply that ozone is dangerous in about a third of the ci ties, but is harmless or even benefi cial in about half the cities. This is not biologically possible, if it is assumed that these associations represent causal relationships.

Instead of focusing only on and relying on th e studies in the literature reporting positive associations, the Agency should address questi ons such as how there can be such a wide variation of ozone associations both positive and negative in the data. It is not biologically plausible that ozone would be causing mortality in some cities in th e summer and protecting against mortality in others. Similarly, it is not pl ausible that ozone is, on balance, dangerous in the summer and protective in the winter.

4. EPA has a duty under the Data Qualit y Act to consider all the results, including both positive and non-positive results.

The 2000 Data Quality Act requires federal agencies to issue information quality guidelines ensuring the quality, u tility, objectivity and integrity of information that they disseminate and provide mechanisms for affected persons to correct such information. 56 According to federal guidelines objectivity in volves both the presenta tion and substance of information. In order for information to be cons idered objective, however , it must be presented in an accurate, clear, complete and unbiased manner, although data subjected to formal, independent, external peer review is presumed to be of acceptable objectivity, the presumption is rebuttable. 57 EPA’s analysis of the epidemiology doe s not meet the standard of objectivity required under the 2000 Data Quality Act because it ignores the inherent va riability of the data by focusing on only the positive results.

55 June 2006 CASAC Letter at 3.

56 44 U.S.C. § 3501 et seq.

57 See Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies ; Republication, 67 Fed. Reg. 8452, 8459 (Feb. 22, 2002).22

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 5. The new data on asthmatics and symptoms/medication use does not provide clear and convincing evidence of an increase in risk due to ozone exposure that was not present in the 1997 Review.

EPA incorrectly concludes that the new evid ence on asthmatics suggests an increased risk compared to that assumed in the previous review:

The Administrator also notes that clin ical studies, supported by epidemiological studies, provide important new evidence th at people with asthma are likely to experience larger and more serious effect s than healthier people from exposure to
O 3

. 58

The discussion of clinical studies in Section 6.3.2 of the CD indicates that there are some studies that report slightly higher func tional responses in asthmatics compared to normal subjects, some studies that report similar re sponses, and one new study that reports lesser responses in asthmatics. In the 1996 review, the Agency c onsidered this issue a nd developed separate guidelines for evaluating the adversity of respir atory effects for health y individuals and those with impaired respiratory systems. The same gui delines are included in the SP. Therefore, there is no important new information from clinical studies that changes the interpretation of risk for asthmatics relative to healthy individuals compared to that in the previous review. However, the overall risk for both groups is lower than thoug ht in 1996 due to the n on-linear nature of the pulmonary function responses noted above.

The SP refers to a number of panel studies that report associations of ozone with daily symptoms/asthma medication use. The SP and CD stress the multi-city study of Mortimer et al. 2002 as providing a sample of asthmatics that is mo st representative of the U.S. The SP cites the CD as indicating that the panel studies as a group indicate a positive association between ambient concentrations and respiratory sympto ms, and increased medication use in asthmatics. 59

The evidence is characterized as much st ronger than in the previous review.

The reliance on single-pollutant results from Mortimer et al. 2002, however, is highly misleading. The Mortimer study presents the re sults of single- and multi-pollutant models. Because the various possible confounders were not all measured in the eight cities, the results are shown for various subsets of the data. Only SO 2 was measured in all eight cities, and when SO 2 was included in two pollutant models, the ozone coefficient was reduced from 1.16 to 1.11 and became non-significant. For seven areas both SO 2 and NO 2 were available. In multi-pollutant models the ozone coefficient was reduced to 1.06 and again was non-si gnificant. In three cities
PM 10 was also available, and in those areas th e ozone coefficient was reduced to 1.04 in a 2- pollutant model with PM 10 and to 1.00 in a multi-pollutant model with all four pollutants. As the authors indicate, only SO 2 remained significant in the seven urban areas with complete data for the three gases. Overall, each of the four pollutants was associated with symptoms in singlepollutant models and the str ongest association was with NO 2 in single-pollutant models and with

58 72 Fed. Reg. at 37,878.

59 SP at 3-10.23

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 SO 2 in multi-pollutant models. In fact, the authors of the study sp ecifically mention that they focus on ozone as a good marker of summer ai r pollution and refer to the study’s finding as effects of summertime air po llution rather than ozone, per se

.
A new study by Schildcrout et al. 60 evaluated the relation between various pollutants and asthma exacerbations (daily symptoms and use of rescue inhalers) among 990 children in eight U.S. cities (including Boston) and reported associ ations with several pollutants, but ozone was unrelated to exacerbations. When the new Schildcrout et al. study is considered along with the nine other studies that are described in the CD as having limited or a lack of evidence for ozone effects, the overall findings relative to e ffects of ozone on asthmatics on symptoms and medication use should be described as mixed and in consistent rather than clear and very strong evidence of an ozone effect.

In addition to man-made air pollutants, confounding by bioaerosols may also be a possible explanation for some of the variation in results for asthmatics. Some bioaerosols are known to exacerbate asthma but are generally not considered or incl uded in air pollution studies. During the 1996 review, EPA staff included moderate or severe pain on d eep inspiration in the exposure and risk assessment. However, the cu rrent CD correctly notes that there is no consistent evidence of an association between ozone and respiratory symptoms in healthy children. Therefore, the Agency does not include this health outcome in the current risk assessment. For asthmatics, however, the curren t risk assessment does include an estimate of respiratory symptoms in Boston us ing associations reported by Gent et al. 2003.

Given the Schildcrout et al . study, the lack of adequate co ntrol for other pollutants (manmade or biogenic), and the overa ll inconsistent results in th e epidemiology data, EPA cannot conclude that the health risk to asthmatics from exposure to oz one is greater than the risk observed in 1997.

6. The claim that a more stringent ozone standard will address the growing asthma problem in the U.S. is without scientific merit.

a. There is no evidence that ozone levels at or below the current standard cause asthma.

Although there has been an increase in asthma in both developed and developing nations in the past 20 or 30 years, outdoor air pollution, in general (and ozone, in particular), has been decreasing. Outdoor air pollution cannot be the cause of the increase in asthma. Changes in living conditions in the indoor environment due to energy conservation may play a role by increasing exposure to common hou sehold allergens such as mold, dust mites and animal dander. A recent Annapolis Center Report 61 concludes that certain allergen s and irritating chemicals, as

60 J. Schildcrout, L. Sheppard, T. Lumley, J. Slaughter, J. Koenig and G. Shapiro, Ambient air pollution and asthma exacerbations in children: An eight-city analysis , Am. J. Epidemiology, advance access published June 23, 2006.

61 Asthma and Air Quality, A Report of the Annapolis Ce nter for Science-Based Publ ic Policy, Annapolis, MD,
2004.24

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 well as passive smoking can cause asthma, but that there is insufficient evidence to determine whether many common indoor or outdoor air pollutants cause asthma.

b. The epidemiology data do not show that ozone levels at or below the current standard cause asthma.

Dockery et al. 62 evaluated asthma prevalence and re spiratory symptoms in a group of 13,369 8 to 12 year old children in 24 communities and reported that the prevalence of asthma or asthmatic symptoms was not associated with chronic exposure to ozone. McConnell et al. 63 followed 3,535 children with no history of asthma from 12 communities in S outhern California. The risk for developing asthma was not greate r in high ozone communities compared to low ozone communities. However, in a subset of children, those playing three or more sports, there was an increased risk of developing asthma in the high ozone communities but not in the low ozone communities. Because the numb er of children in the subset was very low, it is not clear if this is a true effect of ozone combined with high exercise levels. If it is true, the effect is limited to a subset of the population and associated with ozone levels in Southern California in the mid1990s – levels that were substantially above the current standard.

There are many different environmental stimuli that can trigger or aggravate an asthma attack, including weather, changes in weather, bi oaerosols and indoor allerg ens. The Institute of Medicine has concluded that va rious indoor pollutants, primarily biologic agents, and some chemical agents cause exacerbation of asthma. 64 For traditional outdo or air pollutants, the Annapolis Center concludes the situ ation is not as clear because the data are not as consistent as for the major indoor triggers. Although ozone is a candidate for exacerbating asthma, the epidemiologic literature is not c onsistent and implicat es all the major outdoor pollutants to some degree or another.

C. The Evidence on Premature Mortality is too Limited in Nature and Should Not Be Relied Upon in Basing Conclusions on the Health Effects from Exposure to Ozone.

In the 1996 review, there was limited evid ence of an ozone association with daily mortality. The 1996 CD concluded that an associat ion has been suggested, but that the strength of any such association remained unclear at that time. Since then, there has been considerable study of the association of daily mortality wi th ozone and several other major pollutants. The current SP and the proposed rule place significant emphasis on the question of ozone mortality effects, especially from the results of multi-city analyses.

62 D. Dockery, J. Cunningham, A. Damokosh, L. Neas, J. Spengler, P. Koutrakis, J. Ware, M. Raizenne and F. Speizer, Health Effects of Acid Aerosols on North American Children: Respiratory Symptoms , Environmental Health Perspectives, 104: 500-505, 1996.

63 R. McConnell, K. Berhane, F. Gillila nd, S. London, T. Islam, W. Gauderman, E. Avol, H. Margolis and J. Peters, Asthma in exercising children exposed to ozone: a cohort study , The Lancet, 359: 386-391, 2002.

64 Institute of Medicine, Clearing the Air: Asthma and Indoor Air Exposures , 2000.25

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 1. CASAC itself had reservations on the use of the data.

Because of all the issues with the publication bias , model uncertainty, confounding, etc. discussed above, time-series epidemiology of air pollution associat ions is a very blunt tool. CASAC raised this issue in a June 2006 letter to the Administrator noting that “[b]ecause results of time-series studies implicate all of the criter ia pollutants, findings of mortality time-series studies do not seem to allow us to confidently at tribute observed effects sp ecifically to individual pollutants.” 65 Further, due mainly to measurement error issues, they qu estioned the likelihood of ozone itself causing mortality and noted the limitation that measurement error obscures thresholds in time-series studies, adding additional concerns about the utility of the time-series mortality estimates. 66

2. A new NMMAPS analysis that extends the previous analyses, and the Huang et al. (2005) analysis of a subset of 19 large U.S. cities is limited, and does not support a finding of causality.

a. There are major deficiencies in the Bell et al. 2004 paper, including the omission of the wi nter ozone results and limited analyses regarding other pollutants

.
There are major deficiencies in the new NMMAPS analysis, Bell et al. 2004, that omitted winter ozone results and limited the analyses regarding other pollutants. If the positive combined association of ozone with mortality in the summer is causal, it implies that ozone levels well within background ar e linked to premature mortality. Since the ozone exposures of the frail population (since they spend their time i ndoors) will be roughly half or less than that measured at central monitors, the paper implie s that levels well be low background (average exposures of 0.01 to 0.015 ppm) are causing signifi cant mortality. This is not biologically plausible. Bell et al . argue that the pattern of association they observe would be anticipated for ozone since ozone produces acute inflammatory responses in the lung. However, the doses of ozone that result in initial infl ammatory changes are considerably elevated compared to the doses the frail population experience s on a day-to-day basis.

In addition, while Bell et al. focus on the combined associations, the results from the 95 individual cities, shown in Fi gure 7-17 at 7-90 of the CD, ra nge from strongly negative to strongly positive (-6 to + 10% increase in mortal ity per 0.02 ppm increase in 24-hr. average ozone in the previous week). Such a wide range is not biologi cally plausible.

Finally, Bell et al. (2004) provided adjustment for the potential confounding by PM 10. However, Bell et al. did not have the necessary air quality data to provide similar and adequate adjustment for the potential confounding effects of fine PM, which EPA has concluded also causes mortality. Rather, Bell et al. only provided adjustment fo r the long-term average of
PM 2.5. It is well known that ozone is not highly correlated with PM 10 . Rather, ozone levels,

65 June 2006 CASAC Letter at 3.

66 CASAC Letter, EPA-CASAC-06-07, June 5, 2006, at 3 and 4.26

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 particularly in summer, ar e highly correlated with PM 2.5 . Thus, it was not possible for Bell et al. to conclude that the acute ozone mortality signal they observed was due to ozone exposure alone.

b. The pattern of individual-city as sociations in the Huang et al. study is not consistent with a causal association, and may reflect the confounding role of another pollutant.

The largest multi-city study, the National Mo rbidity and Mortality Air Pollution Study (NMMAPS), evaluated air pollutant-m ortality relations in the 90 largest U.S. cities. In 2002, statistical issues with the GAM commonly used in such time-serie s studies were raised and many time series studies (particularly particulate matter studies) were re-analyze d. The SP thus refers to the original NMMAPS analysis and the NMMAPS re-analysis, but focuses on a new NMMAPS analysis 67 that extends the previous analyses and the Huang et al. 2005 analysis of a subset of 19 large U.S. cities.

In the original NMMAPS analysis and in the re-analysis in si ngle-pollutant models, ozone had a small positive combined association in summer, but also a small negative combined association in winter. 68 In multi-pollutant models for the summer case, the combined positive ozone association was reduced and became non-signifi cant at all three lags evaluated as shown in Figure 7-31 of the CD. Ozone is not the only pollutant fo r which NMMAPS seasonal results have been published to date; a seasonal PM 10 analysis has also been carried out. 69 Peng et al. used updated mortality data fr om 1987-2000 in 100 cities and f ound that summer was the only season for which the combined PM 10 effect was statistically significant.

In the Huang et al. study of 19 cities, the pattern of individual-city asso ciations is not consistent with a causal association. For exampl e, the range in individual-city associations is from –6 to + 16% per 0.02 ppm incr ease in 24-hour ozone and lower ozone levels in the cities were associated with higher mortality associations. 70 Also, Huang et al. actually reported that inclusion of PM 10 markedly reduced the ozone mortality coefficients, in many cases to nonstatistically significant levels. The SP also discusses the Gryparis et al. 2004 23-city study and the Schwartz 2005 14-city study. Both studies also reported a very wide range of individual city associations ranging from negative to positive. Sc hwartz notes the negative association in winter and suggests that it may reflect the negative as sociation between wintertime ozone and primary air pollutants. Schwartz goes on then to ask “m ight not the positive asso ciation in the summer likewise reflect confounding with some other pollutant?” Thes e and other possible explanations need to be rigorously considered by EPA.

67 M. Bell, et al. (2004), at 2372-2378.

68 F. Dominici, et al. (2005), at 1071-1092.

69 R. Peng et al. (2005), at 585-594.

70 CD at 7-104.27

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 3. While the SP downplays confoundi ng by co-pollutants, a more comprehensive review of the data implicates other pollutants as potential causes of the reported mort ality associations in time-series
studies.

The SP continues to downplay confounding by co-pollutants resulting in the conclusion that single-pollutant model resu lts should be the baseline for th e quantitative risk assessment. However, several major findings from the Stieb et al. 2002, 2003 meta-analyses (cited in the CD) show that confounding by co-pollutants remains a major problem. Stieb et al. evaluated mortality associations for each of the major po llutants and found a very similar distribution of associations for each in their analysis of 109 se parate mortality/time-series studies. For example, the patterns in Figures 1 to 5 of Stieb et al. 2002 are remarkably similar to one another. They also reported a similar pattern of associations with various categories of death and stronger associations in the warm season than in the cold season for all the pollutants. When multipollutant models were compared to single-pollutant models, the associations were reduced in the case of each pollutant. In the case of ozone, the combined association became non-significant in multi-pollutant models. Since various investigators included different pollutants as potential confounders and different modeling strategies, th e multi-pollutant analyses available in the literature are not a systematic evaluation of the i ssue. Nevertheless, the relative risk reported insingle-pollutant model results was reduced substantially for each pollutant when multiplepollutant models were used. This suggests that the effect observed may not be due to ozone but rather from exposure to ot her pollutants, such as PM 2.5 , that are highly associated with ozone

exposures.

The analysis of the NMMAPS data and findings of the Stieb et al. studies, and the results of the HEI re-analysis, implicate all the pollutants as pot ential causes and/or confounders of excess mortality in time-series studies, and show that stronger associations in the summer are not restricted to ozone. Since the Stieb et al. meta-analyses like the other meta-analyses are subject to publication bias; the associations reporte d are likely to overstate the true associations. Nevertheless, the pattern of results should not be affected by publication bias the way the magnitude is.

The NMMAPS database is valuable because, by including all the largest U.S. cities with data, it avoids the issue of publication bias. On the other hand, it is questionable to use the same approach to adjust for meteorological factors in cities with widely differing weather conditions ( e.g., Los Angeles versus Chicago). The wide range of ozone associations in the data, using the same methodology, demonstrates the inherent noise or variability in the data. The same wide pattern of mortality asso ciations ranging from strongly positive to strongly negative is observed in the individual NMMAPS data for all the pollutants studied (PM 10 , ozone, CO, NO 2 , and SO 2 ) at all the lags studied. 71

71 J. M. Heuss and J. J. Vostal, Comments on the Fourth External Review Draft of Air Quality Criteria for Particulate Matter , EPA 600/P-99/002aD, June 2003, prepared for General Motors Corporation, Aug. 28, 2003.28

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 In the HEI re-analysis, in single-pollutant models, ozone had a small positive combined association in summer, but also a small negati ve combined association in winter. In multipollutant models for the summer case, the combined positive ozone association was reduced and was not significant at all three lags evaluated.

The SP and CD dismiss concern over confoundi ng by gases since the peaks of the various pollutants occur in different seasons and because ozone is generally not highly correlated with other pollutants. This is unwarranted since the Stieb et al. meta-analysis shows that the mortality associations for these potential confounders are strongest in the warm period. The cause or causes of these seasonal patterns ar e not clear. It coul d be a seasonally varyi ng bias that is yet unidentified. It could be relate d to toxic constituents (gases or particles) that have a summer maximum. Since it occurs for each polluta nt, confounding by as yet not understood weather effects is a likely candidate. As discussed in th e next section, many air pollution analysts dismiss weather effects but the substantial seasonal trends in the health data are caused by subtle effects related to changes in weather and human beha vior. Therefore, confounding by weather is a candidate.

4. Weather factors remain a key conf ounder in the mortality analysis relied on by EPA.

A recent paper by Keatinge and Donaldson 72 provides important new insights into the issue of modeling weather effects in ozone studie s. They evaluated whether mortality that is often attributed to ozone and other pollutant s in hot weather results from confounding by neglected weather factors. Their analysis was restricted to days when the mean daily air temperatures exceeded 18 degrees ! C in Greater London from 1991 to 2002, and evaluated mortality counts at an age greater or equal to 6 5. The adjustment for acclimatization was based on the characteristic pattern that has been reported by various i nvestigators that the rise in mortality on hot days is followed by a prolonged re duction in mortality lasting at least 14 days. When only current temperature (average of da ys 0 to –2) was considered in the model, significant mortality was attribut ed to ozone. When they allo wed for cumulative exposure to heat throughout the summer and for sunshine (whi ch contributes to heat stress at any given temperature), the ozone association was reduced by a factor of 10 and wa s no longer statistically significant. This study indicates that previously ne glected weather factor s may be confounding the mortality analyses relied on in the SP. It is noted in the CD that variations in treatment of weather can change the results by a factor of 2 and that publicati on bias can inflate the perceived association by a factor of 3. 73 The Keatinge and Donaldson an alysis suggests th at previously overlooked weather factors can reduce the association by a factor of 10. Thus, the fact that the uncertainty due to model selection is much larg er than the typical confidence limits on any given statistical association sh ould be highlighted by EPA and consid ered in the interpretation of the risk assessment.

72 W. Keatinge and G. Donaldson, Heat acclimatization and sunshine cause false indications of mortality due to

ozone , Environmental Research, 100, 387-393 (2006).

73 CD at 7-96.29

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 D. EPA’s Risk Estimate for Mortality a nd Certain Respiratory Endpoints Fail
to Confirm an Increase in Risk.

There are five significant sources of uncertainty in EPA’s risk assessments for mortality and respiratory health effects:

" EPA failed to show that the associations between ozone and health endpoints are causal

. The risk assessment, therefore, should include a probabilistic consideration that the associations may not be causal.

In contrast to the acute respiratory effects in clinical studies wh ere we know the observed effects are due to the exposure of the pollutant being assessed, the first and main issue in interpreting the epidemiologic asso ciations is determining the ca use of the observed effects. Chapter 5 of the Second Draft SP acknowledged such noting “the most important uncertainty is the extent to which the associations between O 3 and the health endpoints included in the assessment actually reflect causal relationships.” 74 (The final SP acknowledges the five sources of uncertainty as “major” at pages 5-42 and 5-43) Although there clearly are positive associations in the literature for these health end points, the overall pattern of associations is not biologically plausible. In multi-ci ty studies, there is an implausibly wide range of associations for mortality from strongly positive in some cities, to no effect in some cities to strongly negative (implying protective effects) in some cities. The full range for several multi-city studies is shown below in Table 1.

Table 1

Range of Ozone Individual-City Single -Pollutant Mortality Associations in Multi-City Studies Per Standard Ozone Increment as Defined in the CD (subject to model selection uncertainty, but not publication bias)

NMMAPS II (warm season) -6% to + 6% Gryparis et al. (warm season) -8% to + 8% Gryparis et al. (year-round) -12% to + 6%

Bell et al. 2004 (warm season) not reported, but large as shown in CD Figure 7-17 Huang et al. 2005 (warm season) -3% to + 8%

With this range of heterogeneity, the practice of using Bayesian techniques to shrink the city-specific estimates towards the overall mean is highly questionable. The individual-city estimates are dramatically pulled towards the mean and this masks the heterogeneity, especially when the heterogeneity includes both no effect and protective effects.

As noted above, the SP fails to fully acknowledge that the body of studies since 1996 demonstrates major uncertainties and issues re lated to model selectio n and publication bias.

74 Second Draft SP at 5-76.30

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 When the full range of studies in the CD is view ed, the range is also very wide but shifted to more positive findings. This is shown below in Table 2. The heteroge neity implied by these ranges is biologically implausible . While the input from the pa nelists in the December 2005 CASAC consultation varied regard ing the use of these data, ther e was much more skepticism regarding causality than was the case in the PM review. This is reflected in CASAC’s June 5, 2006 letter to the Administ rator that raises serious issues regardin g the use of time-series studies. 75 The risk assessment, therefore, should in clude a probabilistic c onsideration that the associations may not be causal. In fact, the Re gulatory Impact Analysis (RIA) does evaluate the case assuming that ozone mortality associations are not causal.

Table 2

Range of Ozone Individual-City Single-Pollutant Associations in Studies Included in CD Figures per Standard Ozone Increment as Defined in the CD (subject to model selection uncertainty and publication bias)

Figure 7-8 Emergency visits for asthma - 20% to + 90% Figure 7-9 Respiratory hospitalizations - 17 % to + 17 % Figure 7-13 Cardiovascular hospitalizations - 12 % to + 35 % Figure 7-14 All-cause mortality year-round - 8 % to + 7 % Figure 7-19 All-cause mortality by season - 4 % to + 17 %

While staff indicate that there is clear and very strong eviden ce supporting the judgment that the relationships are causal for respiratory symptoms in asthmatic children and respiratory hospital admissions, staff acknowledges that there is greater uncertainty regarding mortality, describing the overall body of ev idence only as highly suggestive. 76 However, as noted above, the latest multi-city study of asthmatic child ren in eight cities, including Boston, found associations with other air po llutants but not with ozone. In addition, the Mortimer study implicates air pollution in genera l, not ozone in particular. Th erefore, the data for asthmatic effects in children is best described as mixed and inconsistent rather than clear and very strong evidence of an ozone effect. The results for re spiratory hospital admissions, similarly, are more inconsistent than staff acknowledges.

" Ambient monitors do not provide an adequate estimate of personal

exposure.

A second major uncertainty staff discusses is related to the adequacy of ambient monitors as surrogates for population exposure. 77 CASAC’s June 5, 2006 letter points out that “personal exposure to ozone is not reflected adequately, and sometimes not at all, by ozone concentrations measured at central outdoor monitoring sites.” 78 CASAC also pointed out that personal

75 June 2006 CASAC Letter at 3.

76 Second Draft SP at 5-76.

77 Second Draft SP at 5-35; SP at 5-43.

78 June 2006 CASAC Letter at 3.31

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 exposures are much lower than ambient and that the susceptible population would be exposed to very low concentrations of ozone indeed. 79 Finally, CASAC poin ted out that ozone measurement error obscures true thresholds in th e concentration-response relationship and that this effect worsens with increas ing degrees of measurement error. 80

Since the true underlying personal exposur e-response relationships implied by the disputed ozone/mortality associatio ns are stronger by a factor of 2 to 4 than the concentrationresponse relationships suggest (due to the fact that i ndoor exposures are 2 to 4 times lower than outdoor exposures), the range of results in multi-cit y studies is actually 2 to 4 times larger (both positive and negative) than that indicated in Ta ble 1. Such a wide range is biologically impossible.

In addition, the fact that the underlying pe rsonal exposure-response relationships implied by these associations are stronger by a factor of 2 to 4 than the ambient concentration-response relationships provides an even gr eater challenge to explain how lo w ozone concentrations, within the range of background, can be causing the pr emature mortality estimated in the risk assessment. If one takes the ozone associations at face value as evidence of effects, then one also has to explain how ozone can be both damagi ng in some cities and protective in others as well as damaging, on balance, in the summer and protective, on balance, in the winter. This pattern is not plausible and is not adequately acknowledged or discussed in the SP or proposed rule. The wide pattern is s hown in Figure 7-17 at 7-90 of th e CD, but downplayed as just heterogeneity due to differe nces in the cities.

" The shape of the empirica lly-estimated concentrati on-response function is uncertain due to uncertainties in m odel selection, shape of the response and confounders.

A third major area of uncertainty noted by staff is a set of issues related to the empirically-estimated concentr ation-response relationships. 81 These include uncertainty related to model selection, shape of the response and confounding. As we document above, the uncertainty in the “true” relation is much larger than the statistical uncertainty in any given association. While staff concl udes that a linear res ponse down to background should be applied, there are many reasons why this should not be the baseline estimate. CASAC rejected this approach for PM even though the PM database was viewed as more consistent. From the controlled human studies, we know that the body has mechanisms to deal with oxidative stress and the first responses are non-linear, transient a nd reversible. Without strenuous work or play for several hours or more, these responses are not found. Respiratory symptoms in healthy children were not included as an endpoint in th is review because the CD concluded that there was no consistent evidence of an association between ozone and resp iratory symptoms in children. Earlier drafts of the CD and SP concluded that the evid ence for respiratory emergency room visits is inconsistent and inconclusive , as is the evidence for cardiovascular hospital

79 June 2006 CASAC Letter at 3.

80 June 2006 CASAC Letter at 4.

81 Second Draft SP at 5-34, 5-76; SP at 5-42.32

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 admissions. Assuming that there are mortalit y effects at background levels violates the coherence guideline from toxicology whereby lesse r effects are seen at lesser doses and greater effects at greater doses. For all these reasons, mortality effects and any effects down to background levels of ozone shoul d be severely discounted.

" EPA’s reliance on GEOS-CHEM fo r estimates of background concentrations signific antly underestimates oz one background levels.

The fourth major uncertainty relates to the use of the GEOS-CHEM model results for policy-relevant background. 82 As documented in comments submitted to EPA by Air Improvement Resources Inc. on behalf of the Alliance [EPA=HQ- OAR-2005-0172-0019] (dated January 17, 2006), the model will systematica lly underestimate the pe ak background levels. Therefore, several alternative higher backgr ound assumptions should be used. They could include a constant 0.040 ppm background, scaling th e seasonal pattern from the Trinidad Head data, and a probabilistic formula tion that provides yearly peak 8-hour values in the range of 0.060 to 0.075 ppm.

" EPA fails to adequately consider the ai r quality benefits of meeting the current standard and overestimates the benefits of alternative standards.

The fifth source of uncertainty relates to the ad justment to the air quality data to simulate just meeting alternative standards. The SP indi cates that the shape of the distribution upon just meeting the current standard or an alternative sta ndard is not known. 83 Importantly, EPA ignores background when rolling back the distribution of ozone concentrations at individual sites. EPA’s rollback misses the increase in ozone concentrati ons near the bottom of the distribution as the man-made influence on ozone is decreased. The rollback overestimates the change in ozone at mid- and low concentrations and, thereby, overestimates the benefits of alternativ e standards. The rollback should be applied to the man-made portion of ozone not the entire distribution. The Agency is in a position to estimate the magnitude of this bias before th e final rule using the ozone modeling carried out for the RI A, and correct the risk assessme nt before a final decision is reached.

As a result of all these uncertainties, the ri sk results presented in Chapter 5 of the SP and summarized in the proposed rule severely misc haracterize the magnitude of the risk and the certainty with which the risk is known. Since there are now more issues and inconsistencies related to the interpreta tion of the time-series studies than there were in 1996, when the decision was made not to rely on ozone/mortality associations, a similar decision is warranted for this review. EPA should acknowledge and discuss the full range of mortality associations in the literature, and the public should be informed that this range is not bi ologically plausible. Comparisons of multi-city results with meta-analyses have demonstrated a major issue with publication bias as noted by Goodman. Goodman ’s caution about publication bias and the

82 Second Draft SP at 5-35, 5-77; SP at 5-43.

83 SP at 5-43.33

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 current weaknesses of single-site repor ts, along with Koop and Tole’s caution 84 about the use of point estimates from time-series to set regulatory standards, need to be carefully considered by the Administrator before the final rule.

1. New studies on emergency room visi ts and hospital admissions do not provide supporting evidence of a causal relationship.

Although EPA’s interpretation of the data on emergency room visits has changed, the evidence remains weak with incons istent results. The literature on emergency room visits shows a very wide range of single-pollutant ozone asso ciations. For asthma–related emergency room visits, the range is from –20 to + 80% per standard oz one increment (0.02 ppm change in 24-hr. ozone or 0.03 ppm change in 8-hr. ozone) as shown in Figure 7-8 at 7-68 of the CD. For total respiratory hospital admissions, th e range is from –15 to +15% per standard ozone increment as shown in Figure 7-9 at 7-73 of the CD.

Although the data remained the same, EPA’ s interpretation changed during the ozone review process. In the Second Draft CD and th e First Draft SP, the conclusion was drawn that the body of evidence remains inconc lusive regarding effects of ozone on the risk of emergency department (ED) visits. 85 However, that conclusion was removed from the final CD and SP and replaced with a statement indicating that there are generally positive associations in summer analyses for asthma ED visits.

The proposal incorrectly notes that the st udies concluded that co-pollutants are not significant confounders:

Most studies in the United States and Canada indicated positive, statistically significant associations between ambient O 3 concentrations and respiratory hospital admissions in the warm seas on. However, not all studies found a statistically significant relationship with O 3 , possibly because of very low ambient
O 3 levels. Analyses for confounding using multipollutant regression models suggest that copollutants generally do not confound th e association between O 3 and respiratory hospitalizat ions. Ozone effect estimates were robust to PM adjustment in all-year and warm-season only data. 86

A number of rigorous evaluations of this literature come to different conclusions regarding consistency and possibl e confounding. Anderson, et al. 1998 87 reported that ozone, SO 2 , NO 2 , and particles all had positive asso ciations with emergency asthma admissions in London, but that

84 G. Koop and L. Tole, Measuring the Health Effects of Air Pollution: to What Extent Can We Really Say that People are Dying from Bad Air , J. of Environmental Economics and Management, 47, 30-54. (2004).

85 See U.S. Environmental Protection Agency, Review of the National Ambient Air Quality Standards for Ozone: Policy Assessment of Scientific and Technical Information: OAQPS Staff Paper – First Draft , EPA-452/D-05-002, Nov. 2005 at 3-8 (referring to the second draft CD at 7-62 as concluding that “t he body of evidence remains inconclusive regarding the effects of O 3 on the risk of emergency department visits.”)

86 72 Fed. Reg. at 37,832.

87 H. Anderson, A. Ponce de Leon, J. Bland, J. Bower, J. Emberlin and D. Strachen, Air pollution, pollens, and daily admissions for asthma in London 1987-92 , Thorax, 53, 842-848 (1998).34

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 there was a lack of consistency acro ss age groups and seasons. Anderson et al. also evaluated 15 other studies of air pollution and daily asth ma emergency visits and admissions in the literature and concluded “Taken overall, it is appa rent that the evidence is not coherent as to whether there is an effect of pollution or the responsible pollutant.” They list a number of possible reasons for the lack of consistency, incl uding false negatives due to lack of statistical power and false positives due to chance, multiple significance testing, post hoc hypothesis testing and publication bias. Th ey also note differences in pollution levels and mix between cities, the presence of highly correlated pollutants, and that pollutants acting as surrogates for unmeasured pollutants or ambien t aeroallergens may be involved. They conclude that, while there is evidence that all of the pollutants may have an effect on asthma, there is a lack of consistency in the specific pollutant responsible.

The review of ED studies during the 2004 ozon e standard review in California indicated that if hospital admissions are affected by ozone, th en it is likely that ED visits would also be affected, and to a greater degree. However, the ED results are less consistent and summarized as being inconclusive, as noted in the first draft SP. The California review 88 noted that of 20 studies they evaluated, 16 reporte d at least one significant asso ciation involving ozone. Given that studies without effects are difficult to publish and that th ese studies often include multiple comparisons, it is not surprising that there would be a number of positive associations in the literature. However, the California review also acknowledged that there is no clear pattern of association with specific respiratory disease outcomes. 89 For asthma ED visits, the results are described as variable. In the 27 studies of daily ED visits incl uded in Table AX7-3 at AX7-40 of the CD, there is a very wide range of results with some multi-year studies reporting positive associations in only some years, with some ozone associations not robust to inclusion of other pollutants, with many single-pollutant associations being positive for only one of many lags or age groups. Therefore, it is hard to accept this data as strong evidence of consistent effects.

For hospital admissions, the 1996 risk assess ment and the current risk assessment both use results from the Thurston et al. 1992 study of New York City. As such, this adds no new information. Also, the current risk assessment for hospital admissions uses the results from a study reporting no consistent increase in respirat ory hospital admissions attributed to ozone in Los Angeles, an area with very high ozone levels . EPA uses one isolated result from the Linn et al. 2000 90 study of hospital admissions disregarding the totality of the results of the study, and the author’s conclusions regardi ng a lack of ozone association w ith hospital admissions. Overall, the risk coefficients for the studies EPA used fo r their 2006 risk assessment are similar to those they used in 1996. The slight increase in project ed rates of hospital admissions is attributed entirely to EPA’s use of a lower background ozone level in the current risk assessment. See the general discussion of ozone bac kground levels in Section H.

88 California Air Resources Board, Review of the California Ambient Air Quality Standard for Ozone

, Staff Report, Vol III, Mar. 11, 2005, at 10-39.

89 California Air Resources Board, Review of the California Ambient Air Quality Standard for Ozone

, Public Review Draft , Vol. II, June 21, 2004, at 12-37.

90 W. Linn, Y. Szlacheis, H. Gong, P. Kinney and K. Berhane, Air pollution and daily hospital admissions in metropolitan Los Angeles , Environmental Health Perspectives, 108, 427-434 (2000).35

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 2. Overall, the school absence data are weaker than noted in the proposed rule and do not confirm causality or effects below the
current standard.

A review of the literature shows that the results of school absence studies are highly dependent on the statistical approach employe d. The SP notes that the association between school absences and ozone was assessed in two relatively large field studies. 91 The SP discusses the Chen et al. 2000 and Gilliland et al. 2001 studies of school absences, but quotes the CD that further replication is needed before firm conc lusions can be drawn. The final CD discusses three analyses of the school absence data from the Southern California Children’s Health Study (Gilliland et al. 2001, Berhane and Thomas 2002, and Rondeau et al. 2005) that used different statistical approaches and assumptions, and came to very different conclusions concerning the presence and magnitude of an ozone effect using the same data set

. 92 This is an indication that the choice of the statistical approach used to analyze the data can change the findings dramatically. Overall, the evid ence for school absence associati ons with ozone is weaker than noted in the SP or the proposed rule.

E. EPA Improperly Characterizes the Impa ct of New Information Since the Last Review, Particularly as it Relate s to Mechanisms of Ozone Action and Support for Causality of Mortality a nd Other Important Epidemiological Health Endpoints.

Controlled studies with animals and cell sy stems fail to provide evidence for either systemic effects or cardiovascular effects except at very high dose levels. There is now a large body of controlled studies with animals and ce ll systems that provide information on ozone effects and the mechanisms that cause those effects. The determin ation of the medical significance of single or repeated exposures to ozone at various levels and the plausibility of various health effects needs to be evalua ted with consideration of the body’s defense mechanisms against pollutants in general and an i rritating gas such as ozone, in pa rticular. These defenses include the presence of antioxidants in the epithelial lining fluid, the mucociliary clearance system, alveolar macrophages and aspect s of the immune system that protect the lung from physical injury, infectious disease and inhaled particles. The CD notes that ozone reacts preferentially with ascorbate, reduced glutathion e, and urate (all antioxidants) in the epithelial lining fluid in a protective response. 93 Ozone also reacts with the carbon-carbon double-bond in polyunsaturated fatty acids. The products of these reactions can signal cellular responses such as inflammation. The CD notes that various models of these reactions do not agree as to whether ozone can penetrate the lining flui d and reach the epithelial cells. 94

The review by Mudway and Kelly 95 indicates that ozone is a highly reactive gas that is consumed by reactive processes on reaching the first interface in the lung and the lung lining

91 SP at 3-12.

92 CD at 7-57 to 7-60.

93 CD at 5-5.

94 CD at 5-2.

95 I. Mudway and F. Kelly, Ozone and the Lung: A Sensitive Issue , Mol. Aspect. Med., 21, 1-48 (2000).36

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 fluid compartment. They note that reactions be tween ozone and antioxidants tend to dominate in this compartment and these are generally thought of as beneficial or prot ective interactions. In their review, Mudway and Kelly discuss a range of antioxidant defenses. Mudway and Kelly further conclude that when ozone is relatively low-- probably less than 0.08 ppm -- the majority of ozone will be neutralized by reactions with uric acid in the nasal passages and upper airways.

As the ozone dose increases, the first effect s of ozone are transi ent, reversible lung function decrements that are a re flex response due to vagal ne rve receptors that involuntarily inhibit maximal inspiratory effort. This response is the body’s reflexive reaction to the presence of an irritant gas and is unrelated to sensations of discomfort. Although it is well-established that ozone causes transient, reversib le lung function decrements, the observational ev idence argues against the presence of chronic lung function d ecrements related to ozone which, if present, would be a public health concern. 96 The acute decrements are decrements in the performance of the lung function test (that requi res maximal inspiratory effort) a nd not a change in lung function of any clinical or pathological significance. Th e threshold for these first effects varies depending on ozone concentration, time of exposure and breathing rate. At somewhat higher exposures, there are mild symptoms and sensations of discomfo rt that also occur. These are also transient and reversible.

As the dose is increased, the reflex res ponse noted above and then immune system responses begin to come into play. Even the immune system responses which are noted as the first indications of “inflammation” are physiological processes that occur in all living organisms under the stimuli of daily life. The first repor ted changes (that occur in humans with heavy exercise after 1- to 3-hours a bove a threshold of 0.18 to 0.20 ppm ) are small and reversible and well within the range of physiologi cal variability. They fall in to the category of biochemical markers that the American Thoracic Society indi cates do not necessarily imply adversity. For example, Mudway and Kelly note that for neut rophils transiting into the lung -- one of the earliest of these responses -- it is not clear if the response should be considered beneficial (functioning to clear necrotic cells) or detrimental (leading to an active inflammation with tissue injury). The CD notes that generally, “the init iation of inflammation is an important component of the defense process; however, its persistence and/or its repeated occurrence can result in adverse health effects.” 97

Based primarily on animal studies, after repe ated doses that induce inflammation or acute high concentration doses, the acute inflamma tion can develop into chronic inflammation, continued inflammation can alte r the structure and function of pulmonary tissue, and tissue injury and/or inflammation can in terfere with the lungs response to other challenges such as other pollutants, viruses, bacteria, and allergens. In general, lesser effects are seen at lesser doses and greater effects at greater dos es. There is little evidence for either systemic effects or cardiovascular effects from the literature on controlled studies unless the doses are such that there are strong respiratory effects.

96 72 Fed. Reg. at 37,833.

97 CD at 5-32.37

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 In controlled studies, there are many instan ces of attenuation of some ozone responses with repeated exposures. In a general sense, these are manifestati ons of the body’s defense mechanisms dealing with and adjusting to the presence of an irritant gas.

There is also now a large body of informa tion related to ozone health effects from observational (statistical correlati on) studies that can lead to a hypothesis of exposure cause and health effects but cannot confirm cause and effect . Since observational (statistical correlation) studies cannot by themselves establish cause and e ffect, a number of factors need to be evaluated before any given association of ozone with a health outcome can be viewed as causal or a real health effect. These factors include the strength, consistency, coherence and biologic plausibility. Biologic plausibility involves both the kinds of effects seen and the doses that cause the effects.

Based on the kinds of effects seen in well- designed controlled human exposure studies, one might predict finding acute lung function de crements, respiratory sy mptoms, and respiratory inflammation in susceptible subjects or in the healthy population in observational studies. One might also consider evidence of chronic respirator y problems associated with ozone plausible. One would not expect to see associations with cardiovasc ular hospital admissions or cardiovascular mortality, but one might not be surprise d to see associations with respiratory hospital admissions or emergency room visits or possibly respiratory mortality. With regard to dose plausibility, one would expect to see thresholds in the data with effects at higher ozone concentrations or in subjects who ex ercise outdoors in the afternoon.

When the epidemiological literature of statis tical correlation studies is compared to this expectation, there are areas of agreement and areas of disagreement. The small lung function decrements reported in field studies of childre n at summer camps and in other populations spending time outdoors may be real but, based on EPA’s guidelines are not medically of

concern. 98 Moreover, EPA indicates there is no consis tent association with symptoms in healthy children or adults. In addition, there is less consistency in the association with symptoms or medication use in asthmatics than EPA claims. The data on respiratory hospital admissions or emergency room visits is also less consistent than EPA claims. Whether the positive ozone associations in the literature for respiratory morbidity are real health effects is not clear at present.

The fact that there is no consistent chronic ozone signal in the data is probably a result of the very low day-to-day exposures of either th e general population or th e susceptible population. For example, in cities where the day-to-day monitored ozone concentr ations range from 0.01 to 0.08 ppm, the personal ozone exposures of th e population are on the order of 0.01 to 0.04 ppm

98 In the 1996 review, the results of six summer camp studie s were analyzed to estimate a 2 to 3% decrease in FEV 1 at 0.12 ppm ozone, which is well within the range of nor mal measurement variability and well below the 10 to 20% changes which are considered moderate and potentially of health concern in the SP. Additional studies published since the 1996 review, for the most part, confirm the earlier results. The issue in interpreting these studies is not whether there are small changes in th e performance of lung function tests, but what these small changes mean for public health given the involuntary re flex mechanism causing the changes.38

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 during normal activity. 99 The mean personal exposures of the population are at or below the mean background, when considering the fact that people spend 90 percent of their time indoors where ozone concentrations are significantly lo wer. Such personal ex posures do not trigger moderate FEV 1 responses through the vagal mechanism and have not been shown to trigger inflammation.

It is not clear how such low personal e xposures could cause or contribute to the premature mortality estimated in the risk assessm ent. The lack of a cardiovascular hospital admissions signal in the data is not consiste nt with the mainly cardiovascular mortality associations with ozone. The likelihood that systemic effects or cardiovascular effects are causing mortality at the low day-to-day personal exposures of the population is also extremely low. As noted in the CD, by protecting against re spiratory effects, systemic effects will likely be protected against also. 100 While the possibility of acute cardiovascular effect s is raised in the CD based on limited epidemiologic findings, the controlled study of Gong et al. 101 which exposed subjects to 0.3 ppm ozone for thr ee hours with exercise found little direct effect of ozone on the heart or vasculature for hyperten sive or healthy subj ects even though many pertinent variables were evaluated. Gong concluded that they di d not find convincing evidence of significant direct cardiovascular effects from ozone exposure, analogous to effects reported in laboratory animals. The indirect effect they report, impaired gas ex change, can be explained as an effect secondary to the respiratory effects of the high ozone exposures.

Another possibility that is discussed in th e CD and SP to explain a small positive warm season ozone association with mortality is that ozone is acting as a surrogate for other photochemical products. However, as noted above, greater warm season associations have been shown for all pollutants and the CD indicates that most widely present non-ozone oxidants have not been shown to have adverse effects in toxico logical studies. 102

Assuming that there are mortality effect s down to background violates the coherence guideline from toxicology, whereby le sser effects are seen at lesse r doses and greater effects at greater doses. For example, Figure 5-15 at 5- 79 of the SP shows that the vast bulk of the estimated mortality is attributable to days on wh ich the 24-hour ozone is 0.040 ppm or less. This ozone level was assumed as mean background in the prior review. Since people spend 90 percent of their time indoors where the ozone exposure is ! to " of the outdoor level, the personal exposures implicated as potentially causing mortality are well below background and there are no medically significant physiol ogical ozone responses at such levels.

As discussed above, the single-pollutant time- series studies that are the basis for the respiratory admissions and mortality estimates ar e subject to a number of criticisms, regarding

99 CD, Table 3-3, at 3-64.

100 CD at 5-57.

101 H. Gong, R. Wong, R. Sarma, W. Linn, E. Sullivan, D. Shamoo, K. Anderson and S. Prasad, Cardiovascular effects of ozone exposure in human volunteers , Am. J. Respir. Crit. Care Med., 158, 538-546 (1998); A full report of the Gong et al. 1998 study is available as a report to the California Air Resources Board, Final Report, Contract No. 93-327, May 2000.

102 CD at 7-2.39

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 publication bias, model selection uncertainty, and an unrealistic range of positive and negative associations in systematic analyses. For all these reasons, EPA should assign significantly less weight to mortality effects and any other resp iratory effects extrapolated down to background levels based on these studies.

Similarly, in both the prior review and the curre nt review, the possibility that there is no threshold for ozone effects was considered, pr imarily based on the observational results. The proposed rule now admits uncertainty with regard to threshold effects:

In summary, the Criteria Document finds that, taken together, the available evidence from clinical and epidemiol ogical studies suggests that no clear conclusion can now be reached with rega rd to possible threshold levels for O 3 - related effects (EPA, 2006a, p. 8-44). T hus, the available epidemiological evidence neither supports nor refutes the ex istence of thresholds at the population level for effects such as increased ho spital admissions and premature mortality. 103

The likelihood of a threshold should also be considered in drawing any conclusions regarding potential mortality risks from exposur e to ozone levels at or below the current standard.

F. The Clean Air Act Does Not Require EP A to Set Standards That Eliminate
All Risk.

Section 109 of the CAA requires the Admi nistrator to set a primary standard, the attainment and maintenance of which in the judg ment of the Administrator, are requisite to protect the public health with an adequate margin of safety. EPA’s task is to establish standards that are “neither more nor less stringent than ne cessary” to protect public health. This does not mean zero risk, but rather at a level that reduces risk sufficiently so as to protect public health with an adequate margin of sa fety. As Justice Breyer noted:

Section 109(b) (1) directs the Administrator to set standards that are “requisite to protect the public health” with “an adequate margin of safety.” But these words do not describe a world that is free of all risk -- an impossible and undesirable objective. . . . Nor are the words “requisi te” and “public health” to be understood independent of context. We consider f ootball equipment “safe” even if its use entails a level of risk that would make drinking water “unsafe” for consumption. And what counts as “requisite” to protec ting the public health will similarly vary with background circumstances, such as th e public’s ordinary tolerance of the particular health risk in the particular context at issue. The Administrator can consider such background circumstances when “decid[ing] what risks are acceptable in the world in which we live.” 104

103 72 Fed. Reg. at 37,840.

104 Whitman , 531 U.S. at 494-95 (Breyer, J., concurring in part and concurring in judgment) (citation omitted).40

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 EPA states in the preamble that its task unde r Section 109 is to esta blish standards that are neither more nor less stringent than necessary for these purpos es. Lowering the standard in light of the 1997 determination woul d result in controls that woul d be more than necessary to protect public health

.

The Supreme Court has agreed with EPA that “requisite” under Section 109 means “sufficient, but not more than necessary.” 105 The material presented in the CD and SP do not support EPA’s proposal to lower the standard. As discussed further in these comments above, EPA’s own assessment of the risks fails to show an increase in ri sk from exposure to ozone. In fact, as stated above, much of the evidence supports a reduction in risk. Given EPA’s data showing limited risks from exposure to the curren t standard and EPA’s analysis of the studies which shows greater, not less uncertainty, in th e likelihood that the observed effects are caused by ozone, EPA should retain the current standard. As EPA states in the preamble, its task under Section 109 is “to establish sta ndards that are neither more nor less stringent than necessary.” 106

G. Since EPA Has Not Provided a Reason able Analysis Supporting its New Judgment on What is Requisite to Pr otect Public Health or Welfare, its Actions Could Be Found to Be “Arbitrary and Capricious.”

In exercising his judgment to revise the existing NAAQS, the Administrator must provide a reasonable analysis for the change. Specifical ly, EPA must explain why its earlier judgment regarding what is requis ite to protect public health or welf are no longer governs. To reverse its position in the face of precedent that is not persuasively distinguished is arbitrary and capricious. 107 Given that EPA’s estimat e of health risks has dec lined and our understanding of the uncertainty surrounding the results of th e health studies has increased, EPA cannot persuasively say why it must depart from its 1997 decision that the current standard is requisite to protect public health.

H. EPA Has Not Correctly Evaluated the Potential Risk Reduction as a Result of its Proposed Change to the Current Ozone Standard.

In the 1997 final ozone rule, EPA estimate d, based on monitoring data, that background levels from natural sources could be as high as .07 ppm. This fact was important to EPA’s decision regarding the level of ozone deemed requi site to protect public health with an ample margin of safety:

As many commenters have not ed, based on information in the Criteria Document with regard to ambient concentrations of O 3 from background sources, an 8–hour standard set at a 0.07 ppm level would be closer to peak b ackground levels that infrequently occur in some areas due to non-anthropogenic sources of O 3

105 Whitman , 531 U.S. at 473 (citation omitted).

106 72 Fed. Reg. at 37,820.

107 Motor Vehicle Mfr.’s Ass’n , 463 U.S. at 42 (presumption “against change s in current policy that are not justified by the rulemaking record”).41

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 precursors, and thus more likely to be in appropriately targeted in some areas on such sources. After taking into account the public comments, and for the reasons outlined above, the Administrator finds th at a standard set at a level of 0.07 ppm is not requisite to protect public health with an adequate margin of safety. 108

EPA’s analysis of background levels in the curre nt review is wholly deficient and does not support a lowering of the standard.

1. In contrast to the 1997 Review, EPA failed to evaluate the extreme values of ozone background levels.

Uncontrollable ozone background levels due to transport of stratospheric air (high in ozone) into the troposphere, transp ort of man-made polluted air fr om locations outside the U.S., and photochemical formation from natural NOx a nd VOC emissions can significantly constrain an area’s ability to reduce ozone concentrati ons. As discussed in the next section, the uncontrollable background also plays a pivotal ro le in EPA’s estimate of the potential health benefits of further reductions in the ozone standard. In previ ous ozone reviews, EPA evaluated this background primarily based on measured observations of ozone and other compounds in remote locations. In the current review, the CD discusses estimates of background from both observations and models, but the SP relies entir ely on one global chemical transport modeling study to model an estimated mean background.

Because of the form of the standard, the background related to the extremes of the distribution of the daily maxima, as well as the means, must be evaluated as was done in the 1997 Review. Ozone background levels must be evaluated for each ozone metric being considered for the primary and secondary standa rds. Since extreme value forms of the ozone standard are being proposed, then measured ozone values or modeled estimates of the extremes of policy-relevant background (PRB) must be considered. In previ ous ozone reviews, both the means and extremes of background were evaluate d. For example, the Agency’s Staff Paper in the previous review concluded:

...a reasonable estimate of the background O 3 concentrations near sea level in the U.S. for a 1-hour daily maximum during th e summer is usually in the range of 0.03 to 0.05 ppm. At clean sites in the western U. S., the maximum annual hourly values are in the range of 0.06 to 0.075 ppm. 109

In the current review, the SP relies solely on the Fiore et al. 2003 110 global modeling study to estimate mean background. However, the CD note s several important limitations of that study and the need for additional work to evaluate P RB with an ensemble of models comparing the

108 62 Fed. Reg. at 38,868.

109 U.S. Environmental Protection Agency, Review of the National Ambient Ai r Quality Standards for Ozone: Policy Assessment of Scientific and Tech nical Information: OAQPS Staff Paper , EPA-452/R-96-007, June 1996 at
20.

110 References denoted by author and year in the text can be found in the CD and SP .42

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 model results with observations. 111 The large grids in the global model mix air parcels of different composition and origin in an unrealistic way, severely li miting its ability to accurately simulate local photochemical activity, intercontinent al transport, and the im pact of stratospheric air inserted into the troposphere. The CD notes the need to include models with greater resolution to understand variability on shorter time scales and vari ability due to processes that are not captured in the global m odels. Until this is done, a range of background estimates from observations only should be used by the Agenc y. Because of the acknowledged limitations of global models, observations should be the primary source for estimates of extreme values of background at specific locations.

The failure of the current final SP to provide information on the extremes of background is a serious omission. As a result, the ranges reco mmended by CASAC and EPA staff overlap with the extremes of background and are unlikely to be achievable in some areas of the country.

2. EPA’s definition of PRB incorrectly excludes man-made emissions
from Canada and Mexico.

The Agency defines a PRB as those concentrations that would result in the U.S. in the absence of anthropogenic emissions in North America; i.e. leaving no room for ozone caused from human activities. However, EPA’s definiti on of PRB is flawed for several reasons. The model exercise EPA relied on omits the contri bution from the emissions from agricultural activities and it omits co nsideration of the contribution to oz one from anthropogenic emissions in Mexico and Canada. While there can be reductions in emissions from agricultural activities, as with other human activities, it would be impossibl e to drive them to zero. No one contemplates the cessation of human activitie s including the practice of growi ng crops and raising animals in the U.S. Omitting the impact of Canadian and Me xican emissions is also problematic because, even though the U.S. may have treaties with these c ountries, zero anthro pogenic emissions and ceasing human activities in these co untries is not a possible future outcome that can be controlled by U.S. regulations.

3. EPA does not provide sufficient rationale for relying on modeled results over monitoring data for as sessing background ambient ozone
levels.

The SP notes that because of long-range transport from anthropogenic source regions within North America, estimates of PRB cannot be derived solely from measurements of

ozone. 112 However, it goes on to state that PRB es timates must be based on modeling. This is

not true. 113 While the transport of plum es from urban areas is well documented in the literature, the CD offers no observation-based analyses to demonstrate that the many instances of ozone greater than 0.06 ppm that are measured at remo te monitoring sites are all caused by transport from urban areas. As documented in Volume II (Annexes 2 and 3) of the CD, there are still major uncertainties and limitations involved in using atmospheric models. The question is not

111 CD at 3-55.

112 SP at 2-54.

113 SP at 2-54.43

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 whether to use observations or models, both observations and models should be used to estimate
PRB.

For example, a recent paper by Jaegle, et al. 114 used satellite observations of NO 2 columns to derive estimates of NOx emissions fr om fuel combustion, biom ass burning and soils. They conclude that there is a significant role for soil NOx emissions at northern mid-latitudes during summer, where they account for nearly ha lf that of the fuel combustion source and a doubling of the inventory used in the GEOS-CHE M model. They furthe r conclude that the contribution of soil emissions to background ozone is likely to be underestimated by the current generation of chemical transport models.

There are NOx emissions from soils due to mi crobial processes. Fe rtilized agriculture produces the highest soil NOx emissions. By turn ing off the agriculture source in their PRB analyses, Fiore et al. systematically underest imated uncontrollable background. Since the total soil source is twice as high as used in the GEOS-CHEM model, Fiore et al. also misallocates the NOx between fuel combustion and natural sources. This will result in a misallocation of ozone between man-made and natural sources. The presen ce of a large soil NOx source in the Great Plains may also help explain the discrepancy between the locations of elevated SUM06 and W126 and the major populated areas of the country.

4. The proposed rule ignores the conc lusions of several researchers and previous conclusions of EPA regar ding maximum background levels.

Recently, Vingarzan 115 reported the range of annual maxi ma at background stations in the U.S. and Canada. The annual maxima (1-hour) at Western U.S. and Canadian background sites approached or exceeded 0.08 ppm.

The level of background ozone first became a policy issue in 1971 when EPA set the NAAQS for Photochemical Oxidan ts at a concentration of 0.08 ppm for 1-hour, not to be exceeded more than once per year. In 1978, Singh et al. 116 reported an analysis of long-term ozone data from remote sites that indicated su mmertime average daily 1-hour maxima in the 0.04 to 0.05 ppm range but maximum 1-hour concentrati ons that can approach or exceed 0.08 ppm in the spring. Singh et al. concluded that achievement of a yearly 1-hour ozone standard of 0.08 ppm may be impossible.

114 L. Jaegle, L. Steinberger, R. Martin and K. Chance, Global partitioning of NOx sources using satellite observations: Relative roles of fossil fuel combustion, biomass burning, and soil emissions , Faraday Discussions, 130: 407-423 (2005).

115 R. Vingarzan, A review of surface ozone background levels and trends , Atmospheric Environment, 38, 3431- 3442 (2004).

116 H. Singh, F. Ludwig and W. Johnson, Tropospheric ozone concentrations and variabilities in clean remote atmospheres , Atmos. Environ., 12, 2185-2196 (1978).44

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 When EPA revised the federal 1-hour ozone standard in 1979 to 0.12 ppm, the Agency acknowledged that:

Field measurements at some remote sites, where man-caused ozone is likely to be negligible, have shown low- but not insignificant- rates of exceedances of the 0.08 ppm level originally proposed for the secondary standard. 117

In 1989, Logan 118 reported the results of an analysis of ozone data from rural locations in the U.S. Logan reported that ozone concentra tions above 0.080 ppm were common in rural areas of the Eastern U.S. in spring and summer (occu rring between about 2 and 8% of the time) but were unusual at remote western sites, occurring less than 0.5% of the time. Logan also pointed out that concentrations of NOx in rural areas of the east are frequently high enough to permit significant photochemical formation of ozone dur ing favorable weather conditions, but that NOx concentrations are much lower in remote region s of the west. The low NOx concentrations in the west are expected due to the low population and emissions density, and effectively limit the local formation of ozone in these air masses. Logan also reported that the median ozone concentrations of 0.03 to 0.04 ppm were similar at rural sites across the country even though there is a much greater population and emission density in the East ern U.S. than in the Western
U.S.

Lefohn and Foley 119 reported in 1991 on an analysis of ozone data from 26 Class I national parks and wilderness ar eas. For the seven cleanest s ites, the yearly maximum 1-hour average concentrations were in the range of 0.06 to 0.075 ppm.

In 1996, Altshuller and Lefohn 120 published an analysis of background ozone in the planetary boundary layer of the U.S. They selected 11 sites for an alysis. The criteria they used included using sites receiving the cleanest air ma sses from the upwind flow off a continent or ocean, and sites isolated from th e influence of urban plumes or regional ozone formation from anthropogenic emissions. They re ported that the maximum 1-hour concentrations in the Western U.S. in the April through October period ra nged from 0.050 to 0.098 ppm and the maximum 1- hour concentrations at coasta l sites ranged from 0.044 to 0. 080 ppm. For comparison, daily maximum 1-hour concentrations are typically1.3 times higher than daily maximum 8-hour concentrations.

In 2001, Lefohn et al. 121 reported an analysis that conc luded that hourly levels of 0.05 and 0.06 ppm are often exceeded at Northern U.S. and Canadian sites specifically selected to minimize anthropogenic influences. Most occurren ces were in April and May but sometimes as

117 44 Fed. Reg. 8202, 8212 (Feb. 8, 1979).

118 J. Logan, “ Ozone in Rural Areas of the United States ,” J. Geophys. Res., 94, D6, 8511-8532 (1989).

119 A. Lefohn and J. Foley, Estimated Surface-level Ozone Exposures in Se lected Class I Areas of the United States

, paper 91-144.2, presented at the 84th Annual Meeting of the Air & Waste Management Association, Vancouver, British Columbia, June 1991.

120 A. Altshuller and A. Lefohn, Background Ozone in the Planetary Boundary Layer Over the United States , J. Air & Waste Management Association, 46, 134-141 (1996).

121 A. Lefohn, S. Oltmans, T. Dann, and H. Singh, Present-day variability of background ozone in the lower troposphere , J. Geophys. Res., 106, D9, 9945-9958 (2001).45

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 late as June. They concluded that many of thes e occurrences were associated with natural ozone sources, particularly upper tropos pheric and stratospheric air.

5. Because the PRB varies substantially, there will be times and places where the background approaches or exceeds the levels recommended by CASAC for both the primary and secondary standards.

The SP attempts to limit the discussi on of policy releva nt background to the meteorological conditions genera lly conducive to peak urban ozone formation. While this is often the limiting case for development of contro l plans, it would not be under the standards recommended by CASAC. The issue is not only what the background is on days of maximum photochemical potential, but also what the back ground is on days with the highest background.

To illustrate, if the background is 0.04 ppm a nd the standard is 0.07 ppm, the amount of ozone that can be allowed to be formed from man-made emissions is only 0.03 ppm. So even with a 0.04 ppm background, a 0.07 ppm standard woul d allow little room for human activities. On a day when the background is 0.06 ppm, th ere would be even less margin for human activities. While this illustration over-simplif ies the complex chemical and meteorological processes involved in ozone formation and trans port, it demonstrates that the variability of background due to transport of ozone from upwind natural and non-U.S. man-made sources can make some of the standards unde r consideration unattainable.

A practical example of this issue is found in Winner and Cass. 122 Winner and Cass modeled the Los Angeles Basin over an entire ye ar and evaluated VOC and NOx controls from 0 to 95 percent. They concluded that the current 8-hour standard may be unattainable in the basin even with complete elimination of man-made emissions and, importantly, they found that the days with lower than pe ak ozone were less responsive to VOC and NOx reductions than the peak ozone days. This means that the days that are most difficult to control are not necessarily the days that produced the peak concentrati ons in the historic al base year.

6. The lack of consideration of the ex tremes of ozone background levels is an omission that led both the Agency and CASAC to assume that
the recommended standards are attainable.

Ozone background concentrations are an important factor in setting and achieving ozone air quality standards and in estimating risk. B ackground concentrations also play a role in the designation of attainment or nonattainment, in the development of State Implementation Plans (SIPs), and in the ultimate achievability of any specific standard. EPA’s failure to accurately assess ozone background extremes resulted in recommendations for new standards that are unachievable.

It is clear from the structur e of the CAA that Congress assu med that air quality standards would focus controls on man-made pollution and w ould be achievable in reasonable timeframes.

122 D. Winner and G. Cass, Effect of Emissions Control on the Long-Term Frequency Distribution of Regional
Ozone Concentrations , Environ. Sci. Technol., 34, 2612-2617 (2000).46

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 Once a standard is set and designations of atta inment/nonattainment are made, the CAA requires states to prepare SIPs to achieve the standard . Under Subpart 1, Se ction 172(a)(2)(A) of the CAA, non-attainment areas must attain the primar y standard “as expeditious ly as practicable, but no later than 5 years from the date such area was designated nonattainment.” 123 The Administrator may extend the attainment date fo r a period of no greater than ten years based on the severity of nonattainment and the f easibility of pollution control measures. 124 Under the ozone-specific provisions of Subpart 2, the Act assigns ozone nonattainment areas with a series of separate deadlines and cont rol requirements based on the degree of nonattainment of the former 0.12 ppm 1-hour standard. In both frameworks, the underl ying assumption is that the standard can be met with man-made controls.

The penalty for failure to meet by the de signated deadline is a bump-up to a higher category with a longer deadline but also more prescriptive contro l requirements in the control region. The penalty for failure to pl an properly is federal sanctions.

In recommending a range of 0.060 to 0.070 pp m, CASAC apparently assumed that an 8- hour standard in this range was ultimately achieva ble from control of U.S. man-made emissions. As documented above, it is not at all clear that th is is the case. One of the specific charges for CASAC under the CAA (Section 109(d )(2)(c)(iii)) is to “advise the Administrator on the relative contribution to air pollution concentrations of natural as well as anthropogenic activity.” 125 A complete reading of the CD indicates that re liance on one particular global model is not a scientifically sound way to estimat e the contribution of uncontrollab le ozone to an extreme value standard.

The CAA also requires CASAC (Section 109(d) (2)(c)(iv)) to “advise the Administrator of any adverse public health, welfare, social, eco nomic, or energy effects which may result from various strategies for attain ment and maintenance of such national ambient air quality standards.” 126 Accurate assessment of ozone backgr ound levels is key to the photochemical modeling used in the SIP development. Phot ochemical grid modeling has moved from the modeling of multi-day episodes in specific urba n areas to modeling ozone concentrations throughout a season over large regions. For the latter situation, an accurate depiction of stratospheric/tropospheric excha nge and subsequent transport is necessary. However, the simulation of stratospheric in trusions is notoriously difficult in global models because stratospheric-tropospheric exchange is an inte rmittent process—a series of strong exchange events separated by more quiescent periods. These events insert stratospheric air high in ozone into layers or filaments in the troposphere. Only rarely do thes e intrusions penetrate to ground level intact, but they intermitten tly insert high concentrations of ozone into the troposphere much more often. The layers or filaments of strato spheric ozone eventually mix with surrounding air in ways which are not yet fully understood, influe ncing ozone levels, photochemical activity and lifetimes of various species. Because of the complexity of these phenomena, an exceptional

123 42 U.S.C. § 7502(a)(2)(A).

124 42 U.S.C. § 7502(a)(2)(A).

125 42 U.S.C. § 7409(d)(2)(c)(iii).

126 42 U.S.C. § 7409(d)(2)(c)(iv).47

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 events policy would not be able to identify the contri bution of stratospheri c intrusions to groundlevel ozone.

When the EPA Administrator set the current federal 8-hour standar d, she considered how close an 0.07 ppm standard would be to b ackground, noting that “As many commenters have noted, based on information in the [CD] with regard to ambient concentrations of O 3 from background sources, an 8-hour standard set at a 0.07 ppm level would be closer to peak background levels that infrequently occur in so me areas due to non-anthropogenic sources of O 3 precursors, and thus more likely to be inapprop riately targeted in some areas on such sources.” 127

The lack of consideration of the extremes of background is an omission that led both the Agency and CASAC in the current review to assume that the standards recommended are attainable. If an 8-hour ozone standard were established at the lo wer end of the range recommended by CASAC, virtually the entire count ry would be designated nonattainment, even areas that are far removed from significant man- made emissions. It would be impossible to develop rational implementation plans for some ar eas and, for other areas, complete elimination of man-made emissions might be re quired to demonstrate attainment.

I. EPA Has Not Adequately Considered That in Many Areas of the U.S. Additional Reductions, Beyond Those N eeded to Meet the Current Standard, May Not Be Achievable With Known Control Technology and Could Impose Ruinous Economic Consequences.

EPA correctly notes that some cities will ha ve difficulty in complying with the current standard within the next decade and invites comment on whether EPA can count the health benefits from these reductions:

As a related concern, a number of areas – including some of the cities involved in the risk assessment – will have difficulty in complying with the current 8-hour standard within the next decade. As a re sult, the full public health gains in these areas from a more stringent 8-hour standa rd are unlikely to be realized for a number of years. In light of the fact that these public health gains may not fully materialize within the attainment date st ructure set forth in the Clean Air Act, some commenters question whether the Agency can or should consider these projected gains as a health based crite rion for its decision making. EPA requests comment on this view. 128

The situation in several areas is direr than implied in the preceding paragraph. The SIPs prepared for the South Coast Air Basin and San Jo aquin Valley of California that were due to EPA in June 2007 lay out the emission reductions required to attain the current 8-hour ozone standard in these air basins. In both cases, the emission reductions required for attainment that were determined using photochemical modeling are massive. Both these areas have been reducing emissions of ozone precursors for many d ecades, yet they still require an additional 75

127 62 Fed. Reg. at 38,868.

128 72 Fed. Reg. at 37,881.48

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 percent reduction in NOx emissions from current levels to demonstrate attainment. 129 The overall reduction from uncontrolled levels is well in excess of 90 pe rcent and the required reduction in emissions per capita or per unit of economic activity compared to uncontrolled levels is even greater. Neither District can iden tify the control strategies that will provide such additional massive reductions so th e Districts are each asking to be reclassified to the ‘extreme’ category so they can take adva ntage of Section 185(e)(5) of th e CAA, which allows extreme areas to submit approvable plans that rely on fu ture advancements in technology, the so-called “black-box” emission reductions.

The San Joaquin Valley District concludes that currently availabl e technology and known technology scheduled for future av ailability cannot provide suffici ent emission reductions to fill the attainment gap. It is noted that this would be the case even if money was no object. In fact, the District concludes that shutting down all businesses, or shutting down agriculture, or removing all truck traffic, or removing all passenge r cars, or replacing a ll motor vehicles with the newest and cleanest vehicles at the cost of $60 billion would not fill the attainment gap. The District notes that these extrem e and unrealistic measures were ev aluated only to illustrate the magnitude of the problem.

The use of the black box allows EPA to a pprove a SIP without havi ng specific identified controls, but the experience withthe black box in the South Coast District has not been favorable. After decades of research and develo pment, the technologies for pollution control are mature and the improvements available now are sm all and incremental. There are no more lowhanging fruit that are available to provide major reductions in emissions in California. Therefore, it is unlikely that either District will be able to identify m easures (short of drastic measures such as those noted above that would cause economic havoc and be a direct contradiction of the Supreme Cour t decision) to attain the current ozone standard within the timeframes required by law, even give n the extreme classifications.

In addition, the Winner and Cass modeling stud y, noted above, raises the possibility that the modeling of current ozone episodes may not be the limiting case for ozone attainment and even more emission reductions may be required th an in the 2007 District air quality plans.

EPA’s estimate of health benefits from lowering the ozone standard is based on a definition of policy relevant background that assu mes man-made emissions can be eliminated. This, however, goes beyond the reach of the Act and is in direct contradiction with the Supreme Court decision. As the proposal notes:

As discussed by Justice Breyer in Whitman v. American Trucking Associations

, however, this interp retation of § 109 does not requir e the EPA to eliminate every health risk, however slight, at any economic cost, however great, to the point of

129 See San Joaquin Unified Air Pollution Control District, 2007 Ozone Plan , Apr. 30, 2007; South Coast Air Quality Management District, Final 2007 Air Quality Management Plan , June 2007.49

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 “hurtling” industry over “the brin k of ruin,” or even forcing “deindustrialization.” 130

J. The Agency’s Estimates of Health Benefits Are Highly Sensitive to Assumptions Regarding Background Levels.

The proposed rule notes that changes in the assumed background can either double or halve the estimated mortality effects. 131 This sensitivity to 0.005 ppm changes in background is a demonstration that the bulk of estimated mortality comes from days with ozone concentrations that are very low. This is not biologically plausible.

The sensitivity of clinical respiratory effects to background assumptions is not as large, but is still very important. For example, the Risk Assessme nt Technical Support Document (TSD) 132 shows that the number of exposures of lung function responses of healthy and asthmatic children (Tables 3-28 and 3-31, respectiv ely) is reduced with a 0.005 ppm increase in PRB almost as much as a lowering of the standard from 0.084 to 0.074 ppm. 133 Thus, the choice of background is extremely importa nt in evaluating the adequacy of the current standard and in estimating the public health impact of a more stringent standard.

Given all the issues with EPA’s assumed background noted above, the Agency should reevaluate its assumed background and then re-evalu ate the clinical risks. Only then can the adequacy of the current standard be evaluated on a sound basis. The proposed rule recognizes the importance of this issue and indicates addi tional sensitivity analyses to background will be carried out. 134

K. CASAC’s Conclusion That the Current St andard is Unjustified is Based on Unsupportable Assumptions.

CASAC’s recommendation to tighten the ozon e standard was not based on fundamental changes in the science from the 1996 review, but rather on EPA’s decision to lower its estimate of mean ozone background concentrations and ignore the extremes of background. In 1996, EPA staff and CASAC agreed on a range for the 8-hour standard between 0.07 and 0.09 ppm. 135 When queried individually, no one on the 1996 pa nel recommended a standard below 0.08 ppm. Currently, CASAC recommends a st andard between 0.060 and 0.070 ppm.

The major reason for the difference between th e two panel’s recommendations is that the current panel assumed that mean background was s ubstantially lower than previously thought in 1997. The current CASAC panel did not carefully consider the extremes of background and so

130 72 Fed. Reg. at 37,820 (quoting Whitman , 531 U.S. at 494).

131 72 Fed. Reg. at 37,862, n.45.

132 E. Post et al., Ozone Health Risk Assessment for Selected Urban Areas , EPA 452/R-07-009, July 2007.

133 U.S. Environmental Protection Agency, Ozone Health Risk Assessment for Selected Urban Areas , EPA-452/R07-001, Jan. 2007, Tables 3-28, 3-31, at 3-70, 3-73 (“RA TSD”).

134 72 Fed. Reg. at 37,857, n.40.

135 G. Wolff, CASAC Letter, EPA-SAB-CASAC-LTR- 96-002, Nov. 30, 1995 (“1995 CASAC Letter”).50

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 incorrectly assumed that uncontro llable background was substantia lly lower than thought in the previous review. Based on the information pr esented to CASAC from the GEOS-CHEM model, CASAC was led to believe that ozone backgrou nd levels never exceed 0.040 ppm. As a result, CASAC incorrectly assumed that a standard as lo w as 0.060 ppm is attainable and that, therefore, exposures of concern could be essentially eliminated.

In the previous review, CASAC concluded that the estimates of risk for various alternative standards were very similar after revi ewing the risk assessments for both clinical and epidemiological endpoints. Specifically, the 19 96 panel concluded that there was no “bright line” that distinguished any of the proposed stan dards as being significantly more protective of public health. 136 In making this judgment, the 1996 pane l focused on the overlap and uncertainty between the estimates of the percent respondi ng rather than on the absolute number of incidences. 137 In contrast, the current CASAC Pane l focused on the absolute number of incidences, even though they are only a very small fraction of the potential number of incidences, and again, the differenc es in incidences at alternate standards are minimal.

Beyond the error in evaluating background, th ere are several other ways in which CASAC erred in evaluating the scientific information. Alt hough the Second Draft SP showed that the risk of lung function effects is lo wer than thought in 1997, the current CASAC panel appeared to believe that the APEX model used in the risk assessment for the clinical effects systematically under-predicted measured values. 138 In actuality, the model significantly overestimated the number of exposures of concer n as detailed elsewhere in these comments.

Although CASAC raised serious qu estions regarding the use of time-series studies to set regulatory standards in its June 2006 letter, those concerns we re ignored in the October 2006 letter which uncritically accepted single-pollutant positive associations as evidence of health effects. CASAC failed to provide a reason why the issues raised in the June 2006 letter no longer applies. Since the science did not change, the more logical conclusi on is that the concerns raised in CASAC’s June 2006 letter still apply and should be consid ered by EPA in its review.

For example, the June 2006 letter highlights the issue of exposure measurement error in time-series studies. In addition, the October 2006 letter acknowledges that “Panel members have little insight as to what we would find if we had actual exposure measurements.” 139 Nevertheless, in the October 2006 letter, CASAC claims that ED vi sits for respiratory disease, especially asthma, are relatively strong and rela tively consistent, citing Figure 3-4 of the SP as evidence. 140 However, the apparent consistency in the figure reflects only that there are a number of reports of positive associations with various health endpoints in single-pollutant models in the literature.

136 See the October 2006 CASAC Letter at 11.

137 1995 CASAC Letter at 2-3.

138 See R. Henderson, CASAC Letter, EPA-CASAC-07-001, Oct. 24, 2006 at 11 (“Oct. 2006 CASAC Letter”).

139 October 2006 CASAC Letter at 10.

140 October 2006 CASAC Letter at 10.51

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 In making a judgment with regard to consis tency, CASAC did not consider the way EPA chose to present the data to esta blish consistency. If these we re controlled studies, we would ask how many total experiments were conducted and how many were positive. We should know both the numerator (the number of positive associations) and the denominator (the total number of studies) before we make a judgment about c onsistency. For much of the epidemiology, we have only the numerator. For a given health endpoint, we do not know how many different models, cities, lags, etc. were evaluated. For purposes of drawing conclusions, there is a major difference between 6 out of 6 positive associations of ozone versus 6 out of 60 or 6 out of 600. CASAC did not evaluate the way EPA chose to presen t the data to establish consistency. In fact, the more rigorous analysis of the full body of data by Anderson et al. 1998 establishes that there is little consistency regarding ozone association with ED visits.

L. Tropospheric Ozone Protects Agains t UV-Induced Health Effects.

It is well-established that tropospheric ozone has a bene ficial effect along with stratospheric ozone in protec ting public health from sola r UV radiation. A reduction in tropospheric ozone would act to increase UV exposur es and UV-induced health effects. This topic is discussed in Section 10.2 of the CD and the conclusion is drawn that the beneficial effects of tropospheric ozone cannot be assessed qua ntitatively at this time. This conclusion is troubling and inconsistent with the science. The health e ffects from exposure to UV radiation are substantial and ozone’s causal link to UV radiat ion is better established than is the case for ozone and daily mortality. For example, the CD concludes that “[t]he current evidence strongly suggests a causal link between e xposure to UV radiation and the incidence of both nonmelanoma and melanoma skin cancer.” 141 The CD stresses the uncertainties and limitations in estimating beneficial effects and generally characterizes the impacts as small and uncertain. While this may be true, it is also true of th e adverse health effects from e xposure to ozone implied by many of the epidemiological associations discussed above. When EPA re sponded to a court’s remand to consider UV-related effects of ground level ozone, various estimates of these effects (made by EPA staff, EPA consultants and staff at other government agencies) were discussed at some length. 142 In all cases, there was no disagreement with the fact that ground-level ozone has beneficial effects. The only disagreements cen tered on the magnitude of the effect or the certainty with which it can be estimated.

EPA now argues that one needs to do a deta iled analysis similar to the APEX exposure model to estimate the beneficial UV-related effects, and that all the necessary inputs for such a calculation are not available. EPA, however, does not adhere to this same view when estimating detrimental effects of ground-level ozone on mort ality. Instead, a much cruder observational approach is tolerated that has enormous uncertainty associated with it. This created a clear double standard.

The proposed rule asks for available studies or data that would be relevant to conducting a critical assessment with reasonable certainty of UV-induced health outcomes and how evidence

141 CD at 10-29.

142 68 Fed. Reg. 614 (Jan. 6, 2003).52

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 of UV-induced health outcomes might inform the Agency’s review of the primary ozone standard. 143

Even though EPA indicates it can not make reliable quantitative estimates of beneficial ozone impacts for this rulemaking, quantitative estim ates of UV-related health effects have been made by EPA and others for various reasons. For example, as part of the estimate of the global burden of disease, the World Health Organiza tion (WHO) has estimated that excessive UV exposure is responsible for about 1.5 million di sability-adjusted life years and over 60,000 premature deaths per year world-wide primarily due to cataracts and skin cancer. 144 The situation is complex because people need some UV to maintain adequate Vitamin D levels. In the current review, the potential benefits of ground-level ozone s hould be weighed along with the potential harm, using similar approa ches for each type of effect.

The Alliance recommends that EPA use the same methods the WHO and the Agency did when estimating UV effects and allocate a reas onable portion of those effects to ground-level U.S. man-made ozone. If EPA does not accept such an approach, at a minimum, the Agency should acknowledge that its risk assessment esti mates of ozone-mortality effects do not provide sufficient certainty.

M. The Scientific Data and Precision of Ozone Measurement Monitors Does Not Support Specifying the Standard to the Third Decimal Place.

In recommending the ozone standard be sp ecified to the third decimal place, CASAC overstates the precision and accuracy of curre nt ozone measurements . CASAC recommended that the ozone standard be specified to th e third decimal place in ppm because current measurement technology “allows accurate meas urements of ozone concentrations with a precision of parts per billion.” 145 Although California recently specified an 8-hour ozone standard to the third decimal place in ppm, th e California Air Resources Board (CARB) staff acknowledges that the third decimal place is an uncertain digit. 146 At the 0.070 ppm level, CARB staff indicated that ozone measurements are uncerta in in the third decimal place to the degree of plus or minus 0.003 ppm. Another way of expressi ng this uncertainty is that 95 percent of the true values will be within two standard de viations, or plus or minus 0.006 ppm. The EPA estimate of precision noted in the SP of plus or minus several percent is consistent as is the precision reported for the CASTNET sites where 98 pe rcent of the audits were within plus or minus 10 percent. In discussing the uncertainty due to measurement error, Langstaff notes that federal reference and equivalent methods are requ ired to have a precision of 0.01 ppm for 1-hour average concentrations (40 CFR Ch.1, Section 5 3.21) and that interferen ce with other pollutants

143 72 Fed. Reg. at 37,837.

144 R. Lucas, T. McMichael, W. Smith, and B. Armstrong, Global Burden of Disease from Solar Ultraviolet Radiation, Environmental Burden of Disease , Series No. 13, World Health Organization, Geneva, 2006.

145 Oct. 2006 CASAC Letter at 5.

146 California Air Resources Board, Staff Report, Review of the California Ambient Air Quality Standard for Ozone, Staff Report , Vol II, Mar. 11, 2005, at 6-3.53

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 and humidity can lead to errors in measurements. 147 Given this level of precision, the current round-off procedure is appropriate.

The proposed rule refers to an analysis by C ox and Camalier (2006) that purports to show the impact of measurement error on the design valu e is small -- the order of 1 ppb for precision and 1 ppb for randomly occurring instrument bias. 148 However, there is no reason to assume that the bias is random. EPA has considerable data on the site-specific precision and bias estimates. For example, Langstaff reports bias estimates for individual Boston monitors varying between -7 and + 11 % in 2003 taken from the larger EPA database. 149

Given that the current requirement for the prec ision of monitors is specified to only two decimal places, the staff analysis is not sufficient to support a cha nge to the round-off procedure. Making attainment determinations on the basis of the implied precision of the third decimal place would be inappropriate.

N. While EPA Should Retain the Current Standard, the Form of the Standard Should Be Changed to the Fifth Highe st Daily Maximum 8-Hour Average
Concentration.

While the evidence suggests that the current standard should be retained, EPA should revise the form of the standard to the fifth hi ghest daily maximum 8-hour average concentration. If, as expected, ozone levels attributed to U. S. anthropogenic emissions continue to fall while background levels of ozone from biogenic sources and internati onal sources continue to rise, more areas will be classified as nonattainment due to meteorological variations. A more stable statistic would aid states in their planning effort s and provide regulated en tities greater certainty as to the control requirements th ey must meet. Changing the form of the standard to the fifth highest daily maximum 8-hour average concentrati on better comports with the health risks, which increase with significance with freque ncy of exposure. The lik elihood of any adverse effect warranting protection under the Act with only two exceedances per year of the current standard is minimal.

147 2007 Langstaff Memorandum at 11 (citing CD at 2-25 to 2-26).

148 72 Fed. Reg. at 37,874.

149 2007 Langstaff Memorandum, Table 2 at 11-12.54

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 II. Comments on EPA’s Proposed Secondary Standard.

The EPA proposal 150 indicates that the Administrato r would revise the current 8-hour secondary standard with one of two options. Th e first would be to promulgate a cumulative, seasonal standard expressed as an index of th e annual sum of weighted hourly concentrations cumulated over the 12-hour period from 8:00 a.m. to 8:00 p.m, during the 3-month period in the ozone season with the highest i ndex values. This index is refe rred to as W126, and it would be set within the range of 7 to 21 ppm-hours. The second option would be to make the secondary standard identical to the proposed primary 8-hour standard. EPA is also soliciting comments on an alternative approach that w ould establish a suite of secondar y standards that would contain different ambient levels, with each standard set at a level requisite to protect public welfare based on the variation in plant effect, use and/or loca tion. Under this approach, the specific standard applicable would depend on the classification of areas according to intended use and on the nature and sensitivity of the plant species in that area.

The Alliance believes that there is no evid ence suggesting that the current secondary standard should be revised. The existing standard is requisite to protect the public welfare, and should not be altered.

A. A Careful Review of the Existing Scie ntific Evidence Demonstrates That the Existing Secondary Standard is Re quisite to Protect Public Welfare.

1. All the issues and problems that led the Administrator in 1997 to reject the option of a seasonal ozone metric are still relevant.

In the 1996 Federal Register notice proposing revised ozone standard s, the Administrator recognized many limitations and uncertainties in the available data and analyses regarding secondary standards. The proposal acknowledged th at “the selection of a single averaging time for a national standard will of necessity be a compromise...” and “specifying the form of a seasonal exposure index to corr espond to the relationship be tween vegetation response and O 3 exposure is complicated by the many biologica l variables that influence the uptake of O 3 by the plant and plant responses to such uptake.” 151

The 1996 proposal also acknowledged that “[ b]ecause of a lack of monitoring data, national air quality typical of agricultural cr op growing areas has not been characterized.” 152 Some of the most important caveats and uncer tainties concerning the exposure and risk assessments for crop yield that were listed in the proposal included “[e]xtrapolating from exposure-response functions genera ted in open-top chambers to ambient conditions,...the lack of a performance evaluation of th e national air quality extrapol ation,...the methodology to adjust modeled air quality to reflect at tainment of various alternative standard options,... and inherent

150 72 Fed. Reg. at 37,818.

151 61 Fed. Reg. 65,716, 65,738 (Dec. 13, 1996).

152 61 Fed. Reg. at 65,740.55

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 uncertainties in models to estimate economic valu es associated with atta inment of alternative standards.” 153

Discussing the quantitative analyses carried out at that time, the proposal indicated that “the Administrator acknowledges the significant un certainties in these analyses and recognizes that these benefits should be regarded as rough approximations.” 154 Because of the lack of new data or substantive improvements in the risk assessment, these same issues remain today, contributing a similar degree of uncertainty, as was the case in the prior review.

The 1996 CASAC Panel did not reach consensu s on key issues regarding protection of vegetation. Of the four Panel me mbers with expertise in ozone ve getation effects, two indicated that the open-top chamber experiments produced re sults that overestimated the effects of ozone on plant yield; the other two did not ag ree with there being a positive bias. 155 With regard to the seasonal cumulative metric under consideration at that time, SUM06, two of the experts thought the cumulative form was appropriate but they disa greed as to the appropriate level. The other two experts were uncomfortable with a SUM06 fo rm because they felt it lacked a biological basis. 156

The main reasons given for the lack of agr eement were lack of suffi cient rural ozone data and the lack of relevant plant exposure studies. The Panel conc luded that “[f]ive years from now, if we do not have the results of research coupling ozone air quali ty and plant biology under conditions more representative of ambient fiel d conditions, to avoid the shortcomings of the open-top chamber experiments, then we will continue to be hampered by our inability to come to consensus on the levels of air quality that are protective of vegetation an d ecosystems at the most reasonable cost.” 157

Ten years have now elapsed, and the same concentration-response functions from the open-top chamber studies of the 19 80s are still the only viable data to use to estimate crop loss and the called-for increase in rural ozone m onitoring has not taken place. The 1996 CASAC Panel agreed that the estimates of crop loss at that time were highly uncertain. 158

Although the current CASAC panel recomme nds a stringent cumulative secondary standard, there is little in the new data that re duces the uncertainty reco gnized in 1996. In fact, the current CASAC panel’s recommendations for th e appropriate range of the standard come from a 1997 workshop on secondary ozone standards. 159 If the workshop recommendations are to be used for standard setting, then the studies underlying their ba sis, as well as the method for reaching the recommended values, should be stated in more detail than in the cited workshop

153 61 Fed. Reg. at 65,740.

154 61 Fed. Reg. at 65,743.

155 G. Wolff, CASAC Letter, EPA-SAB-CASAC-LTR-96-006, Apr. 4, 1996 at 2 (“1996 CASAC Letter”).

156 1996 CASAC Letter at 3-4.

157 CASAC Letter 96-006, Apr. 4, 1996, at 5.

158 1996 CASAC Letter at 3.

159 See W. Heck and E. Cowling, The need for a long-term cumulative secondary ozone standard – an ecological perspective , Environmental Manager, pp. 23-33, January 1997.56

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 summary. The basis for establishing a standard should be transparent and reproducible. One of the current CASAC Panel points out that the state of th e science regarding ve getation effects has not changed very much since the last review and, in a minority view, indicates that the case has not been made for a biological basis for either the SUM06 or W126 metric. 160

2. There are problems, flaws and concerns with the SP analysis and vegetation risk assessment that preclude the establishment of a separate secondary standard to protect vegetation.

a. Extremes of background ozone concentrations were not considered.

The same analyses, arguments, and data that apply to consideration of background for the primary standard also apply to the secondary standard. As discussed above, the global model EPA relied on is not capable of resolving the phenomena that contribut e to attainment or nonattainment of secondary ozone standards th roughout the country. In fact, even a more refined, higher-resolution model, the Communi ty Multi-Scale Air Quality (CMAQ) modeling system , which EPA evaluated when developing an “as-is” W126 exposure surface performed extremely poorly in predicting the observed 2001 SUM06 and W126 in the west. When the model was used to predict the SUM06 values at 300 western locations , it had over 300 percent normalized mean error and almost a 300 percent nor malized mean bias. This means that the sources and processes that contri bute to substantial levels of bot h SUM06 and W126 in rural and remote areas in the Western U.S. are not well-cap tured in state-of-the-art chemical transport models. Since CMAQ was developed to focu s on the impact of U.S. man-made pollution sources, the poor prediction performance suggests other sources and processes are responsible for a substantial portion of the elevated SUM06 and W126 levels observed in rural and remote

western areas.

b. The pattern of current W126 level s suggests contributions from both man-made emissions and uncontrollable background.

The map of “as-is” W126 levels included as Figure 7-6 at 7-28 of the SP shows W126 levels exceeding 7 ppm-hr throughout many areas of the country. Although some areas of elevated W126 occur in and downwind of major man-made source areas, other elevated W126 areas occur in less populous areas including: Utah, New Mexico, Wy oming, Kansas and Oklahoma, states where population and density of man-made emissions are only a small fraction of that in the Eastern U.S.

The overall pattern of W126 s uggests both a contribution from U.S. man-made emissions and a background component that could involve biogenic emi ssions, agricultural emissions, long-range transport from non-U.S. sources and a strato spheric component. In particular, W126 levels greater than 7 ppm-hr. exist in many locations throughout the country, including many rural and remote western sites well-removed fr om anthropogenic emission source areas. These

160 2007 CASAC Letter at C-17- C-18.57

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 levels could be explained in pa rt by NOx emissions from soils due to microbial processes. Jaegle, et al. 161 , using satellite observations of NO 2 columns, found that soil NOx emissions were twice as high as assumed in th e GEOS-CHEM model. This will result in a misallocation of ozone between man-made and natural sources. The presence of a large soil NOx source in the Great Plains also may help explain the discre pancy between the locations of elevated SUM06 and W126 and the major populated areas of the country.

c. EPA and CASAC relied on an inadequate model in recommending secondary standards that fall within the range of uncontrollable background.

EPA and CASAC assume, inco rrectly, based on the Fiore et al. 2003 global modeling analysis, that SUM06 or W126 is not confounde d by background ozone. However, substantial levels of both SUM06 and W126 in rural and remote areas are not obviously related to known man-made source areas, and are likely due to su ch factors as soil NOx emissions. As noted above, both models and observations must be used when determining the extent of uncontrollable ozone. Otherwise, a secondary oz one standard may be implemented that is unattainable in reality.

In Figure 3, longer-term W126 data are plot ted for a series of sites across the Western U.S. from the California/Oregon border across Id aho, Wyoming and into South Dakota. All of these sites are substantially removed from major emission s ources and have W126 values generally in the range of 0 to 20. Note also that there are wide variations from year-to-year. There are several important implications from this data.

i. Even sites removed from obvious source ar eas have a substantial number of hours annually at or above 0.06 ppm, often on the order of 100 to 200 hours per year. Importantly, all these sites have 8-hour design values of 0.06 or greater.

ii. The W126 metric varies substantially from year-to-year even in rural and remote areas lacking any obvious influence from anthropogenic sources. In addition, in 2001, the year used by EPA to model “as-is ” W126, it appears to be an anomaly compared to all the other years. Thus, the ranges recommended for a W126 standard are even more stringent an d more likely confounded by background than apparent at first glance. With such larg e variations, if a W126 or other cumulative standard is set using only one year’s data, areas co uld bounce in and out of attainment, causing havoc with implementation planning efforts. Even three years of data does not appear to provide a stable statistic for implementation planning.

161 L. Jaegle, et al. (2005) at 130, 407-423.58

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 0 2 4 6 8 10 12 14 16

Calendar Year Butte, ID
Campbell, WY
Custer, SD
Jackson, OR
Jackson, SD
Minnehaha, SD
Pennington, SD
Siskiyou, CA

Teton, WY W126 Trends by Rural County

Air Improvement Resource, Inc. Figure 3

d. There is no new data on vegetation e ffects suitable for establishing secondary standards.

The vegetation risk assessment utilizes the cr op yield loss and seedling growth data used in the previous review. Due to the lack of new data, the vegetation risk assessment does not materially reduce the major un certainties that were acknowle dged in the 1996/1997 review.

e. The choice of an appropriate ozone me tric to protect vegetation is difficult.

Although cumulative ozone metrics offer ad vantages over the fo rm of the primary standard to protect vegetati on, the limitations and simplificat ions involved with cumulative ozone metrics are still of concern. For exampl e, the simplifying assumptions that plant exposure to ozone equals plant response, and that there is a uniform th reshold or response function for plant injury are both known to be incorrect. In sp ite of these issues, EPA staff and CASAC recommend a seasonal cumulative secondary ozone standard. Although more biologically-based flux-based models offer promise, there are insufficient data to apply them at present. The decision to ask for comments on establishing a su ite of secondary standards is an implicit acknowledgement of the problems w ith a national seasonal cumulativ e standard. However, there is insufficient data to establish a suite of standa rds that would vary with vegetation type and/or location and it is not clear how su ch a suite of standards could be implemented under the current
CAA.59

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 f. The European experience with cumulative standards has been disappointing.

While both EPA staff and CASAC recommend a cumulative ozone metric, the European experience with cumulative ozone metrics has been disappointing. In a se ries of recent papers, 1 European researchers have acknowledged that the AOT40 2 critical level adopt ed in Europe has proven to be unrealistic and unattainable and have called for revisions to the approach. In addition, it has been reported that visible symptoms at 83 sites in five countries had no relation to the cumulative exposure metric and that crown defoliation of beech was only related to ozone exposure at very high exposure le vels, seven times the European critical level for forests.

In fact, in the European approach, the cumula tive seasonal metric was chosen as a first step that evaluated the potential risk to vegetation, while recogni zing that it does not take into account environmental factors that modify oz one uptake, plant defense mechanisms, or differences in ozone tolerance between species. The Europeans are now working on their second level approach which will be flux-based.

g. The analysis used to discriminat e between cumulative standards and the current 8-hour standard is flawed.

A major consideration in the choice of a seasonal standard was the assessment of the extent to which an 8-hour st andard would provide protection for vegetation. The assessment involved a comparison of the “as-is” W126 expos ure (Figure 7-6 of th e SP) with the W126 exposure rolling back 8-hour ozone concentrations to meet the curr ent standard (Figure 7-7 at 7- 30 of the SP). This comparison is misleading, be cause the rollback appro ach assumes that there will be no reduction in ozone at sites that curren tly attain the 8-hour standard. In reality, there are many national and regional em ission reduction programs that will reduce man-made ozone throughout the country, and measur es adopted through the SIP pro cess that will also reduce ozone in current attainment as well as nonattainment areas.

The Agency is fully aware that the rollback approach underestimates the benefits of attaining the alternative standards. The RIA used the monitor rollback appr oach for some of its calculations, and the Agency acknowledges that th e approach understates the benefits that would occur due to implementation of actual controls because controls implemented to reduce ozone concentrations at the highest monitor will result in reductions in ozone at attaining monitors and other nonattaining monitors. 3 If the rollback appr oach understates the bene fits of alternative standards it also overstates the risk re maining after just meeting the standard.

1 See M. Ferretti, F. Bussotti, V. Calatayud, M. Schaub, N. Krauchi, B. Petriccione, G. Sanchez-Pena, M. Sanz and E. Ulrich, Ozone and forests in South-West Europe – What have we learned? Environmental Pollution, 145, 652-655 (2007), that summarizes the findings from monitoring of fo rest conditions and ozone at 83 sites in France, Italy, Luxembourg, Spain and Switzerland over the years 2000-2002.

2 The AOT40 metric is the seasonal accumulated dose of the hourly concentrations above a threshold of 0.040 ppm.

3 RIA at 6-99, 8-1560

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 The form of the current 8-hour standard, while not designed to protect vegetation, does focus control on the precursors of man-made ozone and consequently will reduce the overall level of man-made ozone throughout the country. EPA’s analysis to date does not evaluate the impact of the nation’s ozone control program on W126 in a scientifically sound manner. Before a decision regarding the protectiveness of an 8-hour standard is made, a realistic evaluation of the ozone reductions throughout the country must be made using state-of-t he-art photochemical models. The draft RIA did not include such an analysis.

In addition, the EPA analysis has focused on determining if the proposed seasonal air quality targets could be exceeded in areas where th e 8-hour standard is met. Starting with the basics, however, an analysis of the exposure-response data to de termine if effects are observed for exposures which do not exceed the 8-hour sta ndard has not been presented. The ecological effects data are provided generally as season al means or cumulativ e (SUM06, W126) values, which may include multiple exceedances of the 8-hour standard. This is particularly true for the crop studies that form the basis of the EPA and CASAC recommendations , which have multiple hourly peaks > 0.10 ppm.

h. The estimates of crop loss are subs tantially lower than those of the previous review.

The SP acknowledges that the estimates of crop loss for the species evaluated are substantially lower than in the previous review. As a result, the economic benefits associated with attaining various alternative standards have been substantially lowered from previous ozone yield loss studies. 4 It is now widely accepted that oz one concentrations at the “standard measurement height” are not the same as the ozone exposures at plant height. When this factor was corrected in the vegetation risk assessment, the SUM06 and W126 exposures at plant height were approximately half those at measurement height.

i. Studies of foliar injury do not support a cumulative metric.

The map of locations where foliar injury wa s present and absent in 2001 (Figure 7-19 at 7-62 of the SP) shows a patchwor k of responses that, in many ca ses, are not obviously correlated to major areas of man-made precursor emission. Although foliar injury is observed in areas that meet the current 8-hour standard, there are also high and low SUM06 areas that experience foliar injury and areas that do not. Si milarly, the European experience indicates that there was little or no relation between a cumulative metric, AOT40, and fo liar injury at 83 sites in five countries.

At a site in the Northeast Corridor of the U. S. where ozone levels are elevated, Davis and Orendovici 5 report that there was no readily apparent relationship between SUM06 ozone levels and incidence of ozone stipple. SUM06, by itself , was not a reliable pred ictor of ozone foliar injury, but when included with N100 (the number of hours of 0.100 ppm or higher) and drought stress, a cumulative ozone metric such as W 126 did have substantial predictive power.

4 SP at 7-52.

5 D. Davis and T. Orendovici, Incidence of ozone symptoms on vegetation within a National Wildlife Refuge in New Jersey , Environmental Pollution, 143, 555-564, 2006.61

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 Although the SP mentions the possible use of N 100 along with a cumulative ozone metric, it took no position on the question. Clearly, this is an important issue that should be evaluated fully by EPA.

j. CASAC made its recommendations based on the draft SP that contained errors overstating the m agnitude of vegetation effects.

There were major errors in the translation of the results of the vegetation risk assessment in the Second Draft SP, overstating the magnitude of crop loss from ozone. For example, the table summarizing the results of the crop loss risk assessment in the appendices to the second draft SP (Table 7E-4) reported the maximum yield loss for various crops (8 crops and 7 fruits and vegetables) but labeled the numbers as the me dian yield loss. This grossly overstated both the yield loss from current ozone levels, as well as the yield gain from attaining any of the alternative secondary standards und er consideration. While this was corrected in the final SP, CASAC made its recommendations concerning the secondary standard based on the draft text that contained numerous errors ov erstating the magnitude of vegeta tion effects. Moreover, the SP still only discusses the maximum yield loss figures. The actual distribution of yield loss/gain can only be found in Section 5.4.1 and Appendix G of the TSD, 6 which indicates that the mean and median yield gains from attaining any of th e alternatives under consid eration are quite small – the order of 1 percent or less for even the most stringent standards. For example, the mean yield gain for cotton (compared to the 2001 “as-is” baseline) from attaining a 13 ppm-hr W126 standard is 0.19 percent and the mean yield gain for soybeans from attaining a 13 ppm-hr W126 standard is 0.14 percent. In contrast, the second draft SP had indicated that there would be the orders of a 7 % mean yield gain for cotton and 2.5 % for soybeans.

k. The recommended range for a cumulative standard needs to be adjusted upward.

The CASAC suggestions for the range of a SUM06 or W126 standard come from a consensus-building workshop held in 1997. The EPA staff’s reco mmended range also considered the results of the 1997 Review and risk assessment. Since neither of these sources considered the difference between the ozone monitored in the ne twork and the ozone exposure at plant height, these ranges should be re-evaluated accordingly.

If ozone monitoring is continued under the current guidelines, the ranges for a seasonal secondary standard would have to be adjusted upward. Ba sed on the reduction in ozone exposure at plant height of a factor of 2 comp ared to that at measurement height, the range should be increased by roughly a fa ctor of 2. Neither CASAC nor EPA took this into account in making their recommendations concerning th e level of the secondary standard.

6 J. Lehrer, M. Bacou, B. Blankespoor, D. McCubbin, J. Sacks, C. Taylor and D. Weinstein, Technical Report on Ozone Exposure, Risk, and Impact Assessment for Vegetation , EPA 452/R-07-002, Jan. 2007, Appendix G.62

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 l. The tools needed to implement a seasonal ozone standard are not in place

.
The placement of current ozone monitors is not appropriate for evaluating vegetation exposure in terms of either spat ial coverage or monitor height . Therefore, a new monitoring network must be designed and implemented before designations of attainment or nonattainment occur. Based on work-to-date, a model suitabl e for developing cont rol strategies for a cumulative seasonal standard, particularly in the Western U.S., is not avai lable. In addition, major improvements would be needed in grid ed emission inventories throughout the U.S. particularly for agricultural emissions. Theref ore, the tools needed to implement a seasonal ozone standard are not in place.

When the timeframe required implementing a new monitoring network, to collect data for several years, and to develop an d approve an implementation plan is considered, the next ozone review will have been completed before implem entation plans will be in place. Ozone reviews are required every five years and EPA recently ch anged the review process dramatically to meet the statutory requirement. As an example of the timeframe needed to implement a standard when a new monitoring network is required, the PM 2.5 standards were set in 1997 and the SIPs are due to EPA in 2007.

All this assumes that tools are available when needed, sources responsible for the nonattainment can be identified, a nd the standard is attainable in the sense that reduction or elimination of the identified sources is at least th eoretically possible. To the extent that any of these steps are not possible, the setting of a seas onal secondary standard will not be fruitful and will not aid materially in the protection of vegetation.63

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 III. Comments on EPA’s Regulatory Impact Analysis for the Agency’s Proposal to
Revise the National Ambient Ai r Quality Standards for Ozone.

The Regulatory Impact Analysis (RIA) EP A issued on August 2, 2007 estimates potential incremental benefits and costs of reaching a stan dard in the year 2020 in the range EPA proposed (0.070 to 0.075 ppm, and at two other levels on which the Agency is taking comment (0.065 and 0.079 ppm).

The RIA concludes that the annual net be nefits for implementation of the proposed standards ( i.e., 0.070 to 0.075 ppm) in 2020 range between -$20 billion and +$23 billion. Because of the high degree of unc ertainty in these calculations , EPA cannot estimate whether costs will outweigh benefits, or vice versa

. 168 An analysis of the RIA suggests that many of the potential benefits may not be realized while the es timated cost is likely to be significantly greater than the estimates suggest. The RIA shows that attainment of any alternative ozone standard is going to require massive new control programs that will affect most part s of the country and many sectors of life. After th e application of every known control measure, substantial areas of the country still fail to atta in the current standard.

A. EPA’s Alleged Benefits From Lowering the Ozone NAAQS Are Not Likely to
Occur.

Most of the benefits estimated in the RI A are due to the avoidance of premature mortality. For the upper-end estimate of the bene fits, EPA assumes that premature mortality is linked causally to both ozone and PM 2.5 . The Alliance takes issue with both of these causal assumptions. For the lower-end estimate, EPA assumes premature mortality is only linked to
PM 2.5 and not to ozone. Because emissions of NO
x will need to be reduced to meet any of the proposed alternative ozone standards, ambient c oncentrations of fine particulate nitrate, a component of PM 2.5 , will also be reduced. In fact, estimated benefits from reduced PM 2.5 pollution make up between 13 and 99 percent of the estimated benefits of meeting the alternative standards.

Since only observational studies are used in the RIA, judgments are necessary in selecting the health endpoints a nd concentration-response functions to include from a wide range of available associations in the literature. As indicated above, there are major issues of model selection and potential biases involved in interp reting the air pollution epidemiologic literature. The current practice of using central station mo nitoring data, central station weather data, andavailable health statistics yields many weak positive associations for various pollutants in timeseries analyses. However, the full range of associ ations in the literature is very wide, with both positive and negative associations, and it is known that the methodology is subject to problems of measurement error and exposure misclassificat ion, as well as severe collinearity between weather and pollution variables. When the uncert ainty due to model sele ction issues is added and the potential biases are considered, the inte rpretation of a subset of positive findings as

168 RIA at 8-10.64

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 causal becomes problematic. Therefore, the use of epidemiological studies for health effect benefit estimation is highly uncertain.

The most important uncertainty relates to the assumption of causality. The second most important uncertainty is due to the assumpti on of no threshold for most of the evaluated endpoints. The SP indicates that the bulk of estimated prematur e mortality accrue at 24-hour concentrations below 0.04 ppm which is close to the backgr ound assumed in the previous review. The CD and SP acknowledge that only a few ozone studies have examined the shape of the concentration-response function. The Special Panel of the Health E ffects Institute Review Committee recently raised several cautions in interpreting epidemiological concentrationresponse results. They point out 169 that measurement error could obscure any threshold that might exist and note that city-specific concentra tion-response curves (for particulate matter, in this instance) exhibited a variety of shapes. Th ey also caution that th e standard approach of minimizing the Akaike Information Criterion ma y not be appropriate for choosing between models. The HEI Panel finally cau tions that lack of evidence against a linear model should not be confused with evidence in favor of it. CA SAC has raised similar concerns regarding the inability of time-series studies to identify the presence or absence of thresholds. The use of a linear ozone effect model as the default should not be accepted until it is demonstrated with controlled studies that low dos es within the range of background are capable of eliciting significant biological effects.

There are specific concerns with each of the health endpoints includ ed in the RIA, as discussed in detail in the following sections.

1. EPA’s estimates of acute morta lity rely on weak epidemiology evidence and incorrectly assume causality.

The RIA acknowledges considerable uncertain ty in the ozone/mortality relationship including the possibility that the ozone/mortality association may not be causal. However, the RIA inappropriately goes on to include estimates of health benefits that presume acute mortality from exposure to ozone. These estimates are based on the Bell et al. 2004 NMMAPS analysis, and the three meta-analyses sponsored by EPA in 2005. Since the proposed rule acknowledges that the three meta-analyses are subject to publi cation bias, those results should not be included in the final RIA.

There are several reasons why even the NMMAPS results are not consistent with a causal relationship and should not be used as the basis of a health benefits analysis. The RIA notes CASAC’s concern that time-series analysis is a blunt tool that implicates all pollutants and it notes EPA’s request that the National Academy of Sciences (NAS) evaluate the evidence.

169 See Commentary by Health Review Committee in M. Daniels, F. Dominici, S. Zeger and J. Samet, National Morbidity, Mortality, and Air Pollution Study, Part III: Co ncentration-Response Curves and Thresholds for the 20 Largest U.S. Cities , Health Effects Institute Research Repor t Number 94, Part III, May 2004.65

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 The CD and SP acknowledge that there is a l ack of consistent effect on respiratory mortality. Although this is blamed on a lack of statistical power, CASAC questions this interpretation. 170 In addition, the Anderson et al. 2004 study reported no association of respiratory mortality with ozone in a meta-analysis of Europ ean studies. There were no statistically significant associations of ozone with respiratory mortality in the 12 studies
evaluated. The overall risk was 1.000 per 10 # g/m 3 increase in ozone. While there was a weak signal of an association of ozone with cardiovascular mortality, the finding of a cardiovascular but not respiratory mortality signal from ozone in si ngle-pollutant models is hard to explain as a causal relation. It is not coherent with the st aff conclusion that the ozone signal in hospital admissions is with respiratory not cardiovasc ular admissions. In the Anderson study, the combined association of ozone with respiratory hospital ad missions was not statistically significant for the five cities available for analysis.

Anderson discusses the issue of publication bias acknowledging that it is a common and possibly universal problem in our research cultu re. Furthermore, they note that there are particular reasons why it might occur in time-seri es studies. These incl ude the large number of associations evaluated and the pos sibility for a selection bias i nvolving the results included in a paper. They also mention a lag selection bias that can be overcome with multi-city studies such as NMMAPS. They further point out that publica tion bias can result in false conclusions being drawn in the hazard identification stage of a risk assessment and result in an inflation of the magnitude of the health impacts. They also recognize that the methods of detecting publication bias are not without problems.

In an earlier meta-analysis, Levy et al. 2001 describe their resu lt as providing weak epidemiologic support for ozone mortality and as potentially biased because it excludes studies that found ozone to be insignificant. After listing a number of such studies and noting that nearly all the studies found ozone not to be a predictor of mortality including all studies in warmer climates, Levy et al. concludes this informa tion must “...give one pa use in using our pooled estimate as a representative measure of ozone mortality risks.” Levy et al. also discuss the difficulties of separating temperature or weather and ozone effects, cautioning that “possible confounding by weather leaves lingering doubt about whether the ozone findings are causal, an issue that would be difficult to resolve epidemiologically.”

Although the RIA relies on the Bayesian adju sted summer ozone/mortality associations from the Bell et al. 2004 NMMAPS analysis, the individual- city data shown in Figure 7-17 of the CD demonstrate a much wider range of associ ations. Such a wide range with many negative associations and few statistically significant posi tive associations is not consistent with a causal ozone effect on mortality. Ther e is another NMMAPS analysis that also raises important concerns. The NMMAPS re-analysis 171 reported a small positive combined association for ozone with mortality in the summer, but a small negative combined association in the winter at lag 0. The lag 0 results were stronger than the lag 1 and lag 2 results. However, an association

170 October 2006 CASAC Letter at 10.

171 F. Dominici, A. McDermott, M. Daniels, S. Zeger and J. Samet, Revised analyses of the National Morbidity, Mortality, and Air Pollution Study: Mortality among residents of 90 cities, J. Toxicology and Environmental Health, Part A, 68, 1071-1092 (2005).66

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 of ozone at lag 0 may be problematic since th e ozone peaks in the af ternoon and mortality is distributed throughout the day, so that a lag 0 association pot entially runs afoul of the temporality requirement that the cause precede the effect.

The wide range of individua l city results in NMMAPS, the overall negative winter association demonstrated in NMMAPS, and th e lack of a significant summer combined association for the 90 largest U.S. cities in the NMMAPS multi-pollutant models all erode the RIA case for causality. The only reported NM MAPS ozone results in multi-pollutant models were for the summer. In each case, when other pollutants were included, the ozone association was reduced and became non-si gnificant. If the ozone associations are not robust to inclusion of other pollutants in the summer when there was a combined small positive association in single pollutant models, it is very unlik ely that they could be causal.

2. The RIA incorrectly bases benefit estimates from reduced hospital admissions for respiratory dise ase on selective studies.

The RIA inappropriately uses selected posi tive associations of oz one with respiratory hospital admissions from the literature. As discussed in the comments above concerning this endpoint, there is less consis tency in the hospital admissions and emergency department ozone/association data than EPA acknowledges. As shown in the NMMAPS mortality analyses, the range of individual city resu lts in multi-city analyses with a consistent methodology is very large (with both positive and nega tive associations) and not biol ogically plausible. The wide range of positive and negative associations in Ito 2003 also indicates that assuming that selected individual city posi tive associations are real health effects overstates the situation. The timeseries studies in the literature can be used to implicate many diffe rent air pollutants as potentially causing respiratory hospital admissions and emer gency department visits, but as Anderson et al. 1998 point out there is lack of consistency in the pollutant responsible or the specific respiratory endpoint affected.

This conclusion is consistent with the emer ging realization in the scientific community that there is increasing evidence for caution in interpreting weak air pollution associations. In order to fully consider the range of ozone/hospita l admissions associations in the literature, the presence of negative studies an d studies with negative associat ions must be acknowledged and the lower limit of estimated zero should be zer o. In fact, the RIA acknowledges that the confidence limits for the pooled estimate for asthma-related emergency room visits includes negative values, so the lower limit fo r this endpoint is indeed zero. 172

172 RIA at 6-16.67

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 3. The data on school absences are weaker than noted in the proposed rule and are not reliable for purpo ses of estimating benefits.

The RIA uses associations between sc hool absences and ozone from Chen et al. 2000 and Gilliland et al. 2001. However, both the SP and CD indicate that further replication is needed before firm conclusions can be drawn rega rding the presence of ozone effects on school absences. The Gilliland et al. study of school absences reporte d a large effect but there is a question of residual seasonal confounding in the study. Furthermore, Gilliland et al. report a substantially larger effect in low ozone communities versus the effect in high ozone communities, a highly counterintuit ive result that necessitates addi tional explanation. Potential confounding by bioaerosols was not evaluated in the study. Thus, it would be particularly important to replicate th e study in another cohort and over all seasons.

The many issues with model selection that ha ve arisen in recent years raise additional concerns that the result may not be robust. Spec ifically, the final CD disc usses three analyses of the school absence data from the Southern California Child ren’s Health Study (Gilliland et al. 2001, Berhane and Thomas 2002, and Rondeau et al. 2005) that used di fferent statistical approaches and assumptions and came to very di fferent conclusions conc erning the presence and magnitude of an ozone effect using the same data set . This is an indicati on that the choice of the statistical approach used to analyze the data can change the findings dram atically. Overall, the evidence for school absence associations with ozon e is weaker than noted in the proposed rule.

The large reported ozone effect on respirat ory absences in Southern California is disproportional to the lack of substantial effects on respiratory symptoms seen in school children residing in the Basin. There are several studies of respiratory symptoms in California that failed to detect symptomatic effects. These include Delfino et al. 1996, Delfino et al. 1997b, Linn et al. 1996 and Ostro et al. 2001. There is a particularly important study of asthmatic, wheezy and healthy children in Southern Ca lifornia that is not considered by EPA. The HEI study by Avol et al. 173 evaluated potential acute respiratory effects of ambient ozone in th e spring and summer. About 200, 10- to 12-year old children from Lancaster, San Dimas, Upland, Mira Loma, Riverside and Lake Arrowhead were studied in the spring a nd late summer of 1994 with monitored hourly ozone levels exceeding the fede ral 1-hour standard in each season, and with peak hourly levels up to 0.20 pp m in the summer period.

Furthermore, there was no consistent or cl ear role of ozone in producing changes in reported symptoms or medication us e. There was also no discer nible pattern of diurnal lung function changes by season, ozone level, or health group. The authors note that failure to detect clear evidence of acute pulmona ry effects in the three groups may be due to insufficient elevation of ozone levels during the study, al though ozone concentrations exceeded 0.08 ppm during the study. The authors not e that children in their st udy on average did not spend a comparable amount of time outdoors or exercising at high levels to the time used in the chamber studies.

173 E. Avol, W. Navidi, E. Rappaport and J. Peters, Acute effects of ambient ozone on asthmatics, wheezy, and healthy children , Health Effects Institute Report Number 82, 1998.68

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 Finally, the lack of a substant ial respiratory symptom signal in several Calif ornia studies is inconsistent with the large effect on school absences reported by Gilliland et al. This difference needs to be acknowledged and discussed in the RIA.

4. EPA should include a lower bound of zero for the benefits of minor restricted activity days.

The RIA uses an association of 2-week averag e ozone with minor rest ricted activity days from Ostro and Rothschild 1989 for this endpoint. The authors note that the association with ozone was highly variable but st atistically significant. They also note that there was no association with respiratory-related restricted ac tivity days (RRADs). Minor Restricted Activity Days (MRADs) are days when people reduce thei r activity but do not miss work or school.

Levy et al. 2001 point out some statistica l issues with the study. Levy et al. raise concerns that the study may not properly meas ure an independent oz one effect. Levy et al. note that of the six years in the study, 1976-1981, the regression coeffici ent was significantly negative in 1977 and 1981. Although the combined result was significantly positive, Levy et al. caution that the magnitude of the oz one impact on MRAD should be c onsidered somewhat uncertain given that “only one older study with statistical issues is available.”

Since ozone was not significantly associated for any year with RRAD, it is difficult to discern what the actual health effect on a MRAD might be and how it could be caused by ozone. Given these issues and the presence of negative as well as positive study results in different years, the lower bound estim ate should be zero.

5. Given questions of PM speciation a nd other uncertainties, the lower bound of the ancillary PM 2.5 benefits should also be zero.

The RIA acknowledges that ancill ary benefits from reduced PM 2.5 pollution make up between 13 and 99 percent of the estimated benefits of meeting the alternative standards. (RIA at 8-10) Because emissions of NO
x will need to be reduced to m eet any of the proposed alternative ozone standards, ambient concentrations of fine particulate nitrat e, a component of PM 2.5 , will also be reduced. Since the base line for the RIA assumes sufficient controls to attain the new
PM 2.5 standards, there are several reasons why re duced nitrate concentra tions, especially at concentrations below the new PM standards, would not be expected to impact mortality.

" The toxicology of nitrate and ot her PM components indicates th at nitrate is among the least toxic PM components. PM air pollution is a mixture of many different kinds of particles69

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 that vary by three orders of magnitude in toxicity per unit mass (AICGH, 2006) 174 and nitrate is among the least toxic of these components. (Schlesinger and Cassee, 2003). 175

" Nitrate exposures of the frail population are substantially below that measured in ambient air. Ammonium nitrate is known to decompos e to gaseous nitric acid and ammonia as it penetrates indoors where people sp end 90 percent of their time with the nitric acid formed being lost on surfaces. 176 Numerous studies report s ubstantially reduced nitrate concentrations indoors compared to ambient concentrations w ith lower indoor/outdoor (I/O) ratios for nitrate than for other ambien t PM components such as sulfate.

" Spatial and temporal distribution of nitrate is opposite to the ac ute health effects signal from PM. Ambient nitrate is highest in winter and higher in the west than in the east. A seasonal NMMAPS analysis is available (Peng et al. 2005) 177 with updated mortality data from 1987-2000 in 100 cities. Summer was the only s eason for which the combined effect of
PM 10 was statistically significant. An analys is by geographic regions showed a strong seasonal pattern in the northeast with a peak in the summer. The authors note several possible explanations. One obvious hypothesis is that the most toxi c particles have a spring/summer maximum and are more prevalent in the northeast. The acute PM health effects signal from this large multi-city study is not consistent with nitrate-caused mortality.

" The spatial distribution of nitr ate is also not consistent with causation of cardiovascular hospital admissions based on th e results of the Dominici et al. (2006) 178 study of PM 2.5 hospital admissions associations for 204 U.S. urban counties. Dominici et al. report a clear difference in the combined associations betw een the eastern and western regions of the country. The combined hospital admissions association is positiv e for cardiovascular outcomes in the east but negative in the west except for heart failure, which is positive in both areas. However, there is an ample literatu re of small positive associations of hospital admissions in single pollutant models with a wi de range of air pollutants, particularly for heart failure, for which the most c onsistent associations are reported. 179 The Dominici et al. results are not consistent with an effect of either generic PM 2.5 or nitrate on cardiovascular hospital admissions and, indeed, th e authors point out the need to shift the focus of research

174 American Conference of Governmental Industrial Hygienists, 2006 Threshold Limit Values and Biological Exposure Indices, Cincinnati, Ohio.

175 R. Schlesinger and F. Cassee, Atmospheric secondary inorganic aerosols: The toxicological perspective as a basis for health effects risk assessment , Inhalation Toxicology, 15, 197-235 (2003).

176 M. Lunden, T. Thatcher, D. Littlejohn, M. Fischer, T. Kirchstetter, N. Brown, S. Hering and M. Stolzenburg, Building a Predictive Model of Indoor Concentrations of Outdoor PM 2.5 in Homes , Report under U.S. Dept. of Energy Contract No. DE-AC03-76SF00098, prepared by Lawrence Berkeley National Laboratory and Aerosol Dynamics Inc., Berkeley, CA, September 2001.

177 R. Peng, F. Dominici, R. Pastor-Barriuso, S. Zeger and J. Samet, Seasonal analyses of air pollution and mortality in 100 U.S. Cities , Am. J. Epidemiol, 161, 585-594 (2005).

178 Dominici F., Peng, R., Bell M., Pham.L., McDermott, A., Zeger, S. and Samet, J., Particles , Air Pollution and Hospital Admissions for Cardiovascular and Respiratory Diseases , J. American Medical A ssociation, 2006, 295,
1127-1134.

179 See M. Goldberg, et al., Env. Res., 91, 8-20 (2003) which reports similar small associations with congestive heart failure for every pollutant included in the analysis.70

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 to identifying those characteristics of particle s that determine their toxicity. The authors also note that their combined result is several-fold lower than other hospital admission associations they cite from the literature, s uggesting publication bias in that lite rature.

The implications of these two larg e multi-city studies are that the PM 2.5 associations in the RIA inflate the magnitude of potential benefits from control of generic PM 2.5 and that the associations should not be a pplied to estimate the benefits of nitrate reductions.

" Regional differences in the chronic mortality signal are inconsistent with nitrate causing chronic mortality. There is a major difference in the chronic PM 2.5 mortality signal between the east and west in the data the RIA relies on that is inconsistent with nitrate-causing chronic mortality. The RIA relies on the Pope et al. 2002 update of the Pope et al. 1995 American Cancer Society Study (ACS) to estimate the ancillary nitrate benefits. However, the lack of a PM 2.5 association with mortality in wester n cities in the ACS cohort was noted by EPA (Grant 2001) 180 in a presentation to the CASAC PM Panel. Staff indicated an
excess risk from 10 # g/m 3 PM 2.5 of +29 percent in the industria l midwest, +25 percent in the southeast, +14 percent in the nor theast, and –9 percent in the west (west is a combination of cities in the northwest, s outhwest, upper midwest, and Southern California NMMAPS geographic regions). The different regional si gnals and other findings from the HEI reanalysis 181 of the chronic PM health studies all ra ise questions concerni ng the interpretation of the chronic PM 2.5 associations as a unive rsally applicable chronic PM health effect. For the RIA, the lack of a chronic mortality signal in the west, where nitrate is a major component of ambient PM, is not consistent wi th the assumption that nitrate causes chronic mortality.

" The expert solicitation that the Agency uses in a sensitivity analysis never addressed the experts’ views on causality of ammonium n itrate or other specific PM components. Therefore, the sensitivity analysis regarding causality is incomple te, as it applies to ancillary nitrate reduction impacts.

" As noted above, all the estimated ancillary PM 2.5 benefits from mo re stringent ozone standards accrue from PM 2.5 concentrations below the new PM 2.5 NAAQS that the Administrator decided was protecti ve of public health with an ad equate margin of safety.

For all these reasons, the lower bound of ancillary PM 2.5 benefits due to NOx reductions should be zero.

180 Grant, L.; EPA Staff Presenta tion to CASAC, July 23, 2001; Key Revisions and Scientific Issues for Second External Review Draft of Air Quality Criteria for Particulate Matter, Slide 46.

181 For example, the Krewski et al. 2001 re-analysis showed that the in creased risk was cardiovascular not respiratory, that one gaseous pollutant, SO 2 , had a strong association with mortality, that when SO 2 was included in the model the PM all-cause mortality association was materi ally reduced and became non-significant, and that the increased mortality was experienced in the portion of th e cohort that had a high school education or less.71

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 B. Even Though the Benefits Are Uncert ain, the Costs of Meeting a More Stringent Ozone Standard Will Occu r and the EPA Analysis Likely
Underestimates Those Costs.

In order to conduct the RIA, EPA used a photochemical grid model to model two different scenarios and then used selected grid modeling results to extrapolate and estimate the number of additional tons of pr ecursor control that would be needed for attainment of the alternatives under consideration.

1. The RIA shows many existing nonattainment areas will not attain the
current standard with all known co ntrol technologies, even when applied to regions outside the nonattainment area.

The first modeling scenario, designated as the 2020 Baseline in cludes all national emission control programs that are on the books or being proposed and many additional local and regional NO
x and VOC control programs that are thought necessary to bring most of the U.S. in attainment with the existing 8-hour ozone NAAQS of 0.08 ppm. The RIA reports (Figure 3.4 of the RIA) that ten counties would not attain the current standard by 2020 with all these known or available controls. The remaining nonattainment areas in clude counties in the Houston metropolitan area, the Lake Michigan area, the No rtheast Corridor, and the South Coast and San Joaquin Valley areas of California. Although on ly ten counties would actually experience ozone levels above the current standard in 2020 in this simulation, the areas affected by such nonattainment are much larger. For the baseli ne, the geographic areas where additional known controls were applied are extens ive, including much of the midwest and the Northeast Corridor and all of Texas and California. This baseline analysis also shows that the application of all known controls would result in 82 counties thatexceed 0.075 ppm standard, which is the highend of the range in the proposed rule.

The second model simulation added a hypothetical national control st rategy for attaining a 0.070 ppm standard by 2020 to the controls in the baseline case. Although described as applying all known or demonstrated contro ls, this emission scenario is a mix of adding known controls in additional geographic areas, adding c ontrols assuming that current technologies can be applied to smaller and smaller sources of the same type, and a dding hypothetical controls that are extensions of existing technology that EPA assumes will be available and effective in the needed time-frame. After applying the hypothetical “known” controls over most of the Eastern U.S. and throughout five additiona l western states -- Nevada, Utah, Colorado, Arizona and New Mexico -- the simulation was only able to show pa rtial attainment of the 0.070 ppm goal. In fact, after these hypothetical controls were added to the baseline, nine coun ties still exceeded the current standard, 50 exceeded 0.075 ppm and 126 exceeded the 0.070 ppm goal as shown in Figure 3.13 of the RIA. No estimates for the number of counties exceeding the 0.060 ppm alternative recommended by many envir onmental activists were reported.

To summarize, the RIA acknowledges that kn own and reasonably an ticipated controls would likely be insufficient to bring many areas into attainment with either the current or72

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 alternative standards. 182 In other words, the Agency does not know how the current standard can be attained thr oughout the country.

2. The RIA relies on unknown control technology to demonstrate
attainment.

Since the measures in the hypot hetical national control stra tegy were not sufficient to bring much of the country into compliance with the alternative standards, a third emissions scenario for 2020 was developed using unknown technology to furthe r reduce NOx emissions so that all places (except two areas in California) would be in compliance with the alternative standards by 2020. This exercise involved deve loping estimates of the emissions needed to provide full attainment but it did not involve te sting in the grid model whether those emission reductions would, in fact, provide full attainment.

The emission reductions in this scenario were estimated from grid modeling runs of the impact of NOx reductions. A si ngle national estimate of the reduction in NOx and VOC in terms of parts per billion ozone reduced per kiloton of precursor reducti ons was used together with the extent of remaining nonattainment to estimate that several million a dditional tons of NOx reductions would provide for attain ment of the more stringent alte rnatives under consideration in the RIA. The cost of full attainment was then estimated based on historical experience with NOx controls in terms of dollars per ton of NOx removed. Even though EPA does not know how these reductions will be achieved, the costs are esti mated by extrapolating the cost from known technologies.

3. The RIA correctly characterizes this extrapolation of costs from known to unknown technologies as a highly speculative exercise. Actual costs are likely to be significantly higher.

The RIA characterizes the extrapolation of costs from known to unknown technologies as a highly speculative exercise, 183 and describes the resulting estimates as providing guidance on the general magnitude of costs and benefits not precise predictions. As standards across multiple pollutants with overlapping precu rsors are tightened, states and affected industries will move further down the list of cost-effective known and available controls, until uncontrollable background and anthropogenic emissions are reache d. The nation has had a major national effort to develop and apply cont rols to reduce ozone and particulate matter emissions for over 40 years. Although much progress has been made, achieving even the current ozone standard throughout the country will require either the invention a nd application of substa ntial additional technology or curtailment of economic activity. Thus, the curre nt standard is a very stringent standard.

The estimated costs in the RIA, as large as they are, may significantly underestimate the true costs of the alternative standards. As the RIA notes, the estimated emission reductions are based on generalized precursor ozone relationshi ps while the actual relationships are highly

182 RIA at 8-11.

183 RIA at 8-11.73

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 variable across the country. 184 The full attainment emission re ductions were restricted to NOx controls, but the remaining ozone problems tend to occur in areas with the greatest population and emissions density (modified by the extent to which the area’s meteorology is conducive to ozone formation). These areas are the large me tropolitan areas where porti ons of the domain are VOC-limited and NOx reductions can both in crease and decrease ozone formation. 185 Thus, full attainment in these areas may be more diffi cult than EPA has assumed in the RIA. The generalized precursor relationshi ps were derived from 36 km gr id modeling runs which tend to exaggerate the benefits of NOx control a nd mask the benefits of VOC control.

All the remaining major nonattainment areas have sophisticated ongoing grid modeling efforts supported in many cases with extensive field studies. Some of these areas were not able to develop and submit attainment demonstrati ons for the current sta ndard by the June 2007 deadline due to modeling issues and the lack of known controls. Others did develop attainment demonstrations that depended on the black box for as yet unidentified controls. The RIA acknowledges that in urban areas with a high population density, ozone is often VOC-limited (RIA at 2-1) and that in these areas NOx reduction s can increase ozone. The RIA also notes that between the NOx-limited and VOC-limited extremes there is a transitional region where ozone is relatively insensitive to changes in NOx and VOC. To the extent that the mix of national and local controls results in areas being in the transitional region, where ozone formation tends to maximized, it may take massive reductions in one precu rsor or the other to come into attainment. Given the large biogenic emissions of both VOC and NOx that need to be included in the modeling, such massive reductions may not be feasib le or achievable in some locations. In the final RIA EPA needs to test its full attainment stra tegies in a nested grid model to insure that attainment of the ozone standard is feasible.

In conclusion, the RIA notes that tightening the ozone standard will incur significant but uncertain costs. 186 The RIA concludes that the hypothetical national strategy to attempt to attain the 0.07 ppm alternative would cost $3.9 billion per year and that the estimated reductions for full attainment of the 0.07 ppm alternative would cost $13 to $26 billion per year. (For the 0.065 ppm standard the estimated nati onal cost, excluding full attainme nt in California, is $17 to $46 billion per year

. No estimate for the 0.060 ppm standard was made. While, as documented above, the benefits of an 0.07 ppm standard (o r any of the alternatives) depend on highly questionable assumptions concerning causality, it is, without question, dem onstrably clear that achieving such a standard will require massive additional emission reductions costing the order of several tens of bill ions of dollars per year on top of the already massive national costs of attaining the current standard. The RIA acknow ledges that the direct benefits from ozone reduction itself are $190 million per year for the 0.07 ppm alternative if it is assumed that ozone does not cause premature mortality. 187 Since the morbidity effects of ozone in the RIA are

184 RIA,, at 8-16.

185 See J. Heuss, D. Kahlbaum and G. Wolff, Weekday/Weekend Ozone Differences: What Can We Learn from Them? J. Air & Waste Management Association, 53, 772-778 (2003); G. Yarwood, K. Bonyoung, T. Stoeckneius, and J. Heiken, Modeling Weekend and Weekday Ozone in Southeast Michigan , ENVIRON International Corporation Draft Final Report prepared for National Renewable Energy Laboratory, Golden, CO, July 30, 2007.

186 RIA at 8-16.

187 RIA at 6-2.74

Comments of the Alliance of Automobile Manufacturers Docket No. EPA-HQ-OAR-2005-0172 highly exaggerated as demonstrated above, all the alternative standa rds below the current standard are expected to be highly cost-ineffective.