### 202-234-4433 Neal R. Gross & Co., Inc. Page 1 U.S. ENVIRONMENTAL PROTECTION AGENCY

+ + + + + CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

OZONE REVIEW PANEL

+ + + + +

PUBLIC MEETING

+ + + + + TUESDAY, JANUARY 10, 2012

+ + + + + The meeting convened in Salon ABC of the Marriott at Research Triangle Park, 4700 Guardian Drive, Durham, North Carolina, at 8:30 a.m., Jonathan Samet, CASAC Chair, presiding.

CASAC MEMBERS PRESENT: JONATHAN M. SAMET, Chair GEORGE A. ALLEN

ANA DIEZ-ROUX ARMISTEAD (TED) RUSSELL HELEN SUH KATHLEEN WEATHERS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 2 PANEL MEMBERS PRESENT:

JOSEPH D. BRAIN

DAVID CHOCK

WILLIAM MICHAEL FOSTER

JUDITH GRAHAM

DAVID GRANTZ

JACK HARKEMA

DANIEL JACOB

STEVEN KLEEBERGER

FREDERICK J. MILLER

HOWARD NEUFELD

JAMES ULTMAN

SVERRE VEDAL

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF

PRESENT: AARON YEOW, Designated Federal Officer VANESSA VU, Director, SAB Staff Office BRYAN HUBBELL, OAQPS

KAREN MARTIN, OAQPS JOHN J. VANDENBERG, ORD/NCEA LYDIA WEGMAN, OAQPS

### 202-234-4433 Neal R. Gross & Co., Inc. Page 3

C-O-N-T-E-N-T-S

Opportunity for Clarifying Remarks from

Members of the Public 4

Discussion of Key Points for

the Draft Letter 5

Adjournment 153

### 202-234-4433 Neal R. Gross & Co., Inc. Page 4 1 P-R-O-C-E-E-D-I-N-G-S

2 8:33 a.m. 3 DR. SAMET: Okay. Good morning 4 and welcome back to day two of the CASAC 5 meeting concerning the second draft ISA. So 6 this morning I think everyone knows that the 7 first thing on the agenda is the opportunity 8 for clarifying remarks from members of the 9 public. This is a new addition to the public 10 comment process. 11 So we just have a couple of points 12 we wanted to make. We're having a brief 13 public comment period this morning for 14 clarifying remarks or technical corrections 15 for the panel's consideration. Speakers will 16 be limited to one minute. Note that you will 17 get a warning when you have 15 seconds 18 remaining. And please do not repeat remarks 19 that you have already made. We, of course, 20 heard from 16 public commenters yesterday and 21 have your oral and other submissions. I 22 think, everyone, we have seven individuals who

### 202-234-4433 Neal R. Gross & Co., Inc. Page 5 1 have signed up with Aaron to make comments, 2 and I think if panel members have questions 3 following their comments we can certainly have 4 some brief interactions. 5 So let's see. With that, Aaron, 6 do you have -- oh, there's the list. Okay. 7 MR. YEOW: So the list is up on 8 the screen, so how about we just have the 9 public speakers start coming up. You can 10 prepare yourselves up there. 11 DR. SAMET: And a warning. Of 12 course, a minute is an amazingly short amount 13 of time. 14 (Laughter.) 15 So let's see how this goes. And -

16 - 17 MR. YEOW: So, Roger, sorry, Dana

18 -- 19 DR. SAMET: The order is up on the 20 screen. We're actually allowing five seconds 21 for transition. 22 (Laughter.)

### 202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 Okay. Ready, set, go. 2 MS. WOOD: Okay. EPA has claimed 3 that background ozone can be dealt with in the 4 implementation process. However, there's no 5 legal way, nor technology available, to do so. 6 The Exceptional Events Rule, which is the only7 mechanism for exclusion of data from the non8 attainment designation process, requires, one, 9 that there be no exceedance or violation but 10 for the event, which is never the case when 11 you're considering background always being 12 there. The event associated with a measured 13 concentration has to be in excess of normal 14 historical fluctuations, including background. 15 Both of these requirements will not allow for 16 excluding background ozone. 17 Furthermore, there are no tools or 18 protocols available for identification and 19 exclusion of exceptional events for ozone, 20 only PM. Even with the use of the tools for 21 PM developed by EPA, states have not been 22 approved for exclusion of exceptional events.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 7 1 Therefore, EPA must deal with the background 2 ozone in the standard-setting process. 3 DR. SAMET: Thank you. I was 4 going to say you were a model, but you were 5 about seven seconds over. But let me ask, any 6 questions or comments? 7 DR. MILLER: Well, I guess we can 8 ask EPA to respond later, but this sounds like 9 a compelling, if it's correct, which I assume 10 it is, why it has to be dealt with in the ISA. 11 DR. SAMET: Yes, I think this is 12 an issue that we will be coming back to. 13 Thank you. Okay. Next, Roger McClellan. 14 DR. MCCLELLAN: I continue to urge 15 preparation of a third draft IS -- integrated 16 science assessment. The policy statement 17 yesterday, every molecule of ozone impacts 18 risk, is not a science-based statement and it 19 requires that the ISA be revised, critically 20 reviewed with attention focusing on ambient 21 background ozone, and the concentration 22 response coefficients for all health endpoints

### 202-234-4433 Neal R. Gross & Co., Inc. Page 8 1 be quantitatively estimated. Particular 2 attention needs to be given to relating the 3 scientific uncertainties in the concentration 4 response coefficients for various portions of 5 the range of coefficients of concentrations to 6 be assessed for each of the concentration 7 metrics and associated statistical forms that 8 are being considered. 9 Moreover, I ask that EPA make 10 publically available any of the science-based 11 models or related computer codes to be used in 12 the preparation of the REA and policy 13 assessments. These need to be critically 14 reviewed by CASAC. Thank you. 15 DR. SAMET: Okay, thank you. 16 There may be an award for the person who 17 actually gets this done in one minute. 18 DR. MCCLELLAN: I did a copy of my

19 -- 20 DR. SAMET: Okay.

21 DR. MCCLELLAN: -- comments -- 22 DR. SAMET: Thank you. Roger,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 9 1 before you go, let me just make sure, does 2 anyone have questions or comments? Okay, 3 thank you. Next, Bruce Copley. 4 DR. COPLEY: Back to the topic of 5 respiratory mortality and ozone. We talked 6 about this yesterday briefly, and this topic 7 will fuel the cost benefit and other economic 8 analyses. 9 I note that nine other studies 10 contradict Jerrett's findings, and Jerrett 11 being the most influential paper, as I said 12 yesterday. These nine studies report no or13 very limited evidence for an ozone-climate14 mortality relation. These studies include 15 three previous updates of the ACS study, the 16 Harvard Six Cities Study, three updates of the 17 AHSMOG study, and the latest update of the VA 18 study, and a new study in an Australian 19 cohort. Using the EPA weight of evidence 20 scheme, these other studies are assigned zero 21 weight. Only one new study, Zanobetti in 2011 22 reports a positive association, but this study

### 202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 doesn't consider confounding by PM another 2 pollutant for which EPA has determined to 3 cause mortality. The approach of ignoring 4 most of the scientific evidence in favor of 5 the result of a single high-quality positive 6 study seems logically flawed. Thank you. 7 DR. SAMET: Thank you. And you 8 were the first to make the minute. Questions? 9 This actually lies with Vanessa and Aaron. 10 DR. VU: The government are not 11 allowed to give prizes. 12 (Laughter.) 13 DR. SAMET: Sorry. Your 14 government lied again. 15 (Laughter.) 16 Okay. Next, Julie Goodman. 17 DR. GOODMAN: Yesterday, I stated 18 that EPA should adopt a framework like the 19 hypothesis-based weight of evidence framework, 20 and I want to clarify today that, while it 21 doesn't need to be this specific framework, it 22 is critical that the framework EPA uses be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 11 1 improved. CASAC has already offered advice on 2 this, and I'd like to quote an October draft

3 letter about the Lead ISA from Drs. Sverre and 4 Samet. They stated, "The causal analysis is 5 not applied systematically or in a transparent 6 way. In assessing studies related to a 7 particular human health outcome, a critical 8 analysis of the strength of evidence is often 9 not done in the more detailed chapters upon 10 which this summary is based. Limitations of 11 the data concerning selected endpoints are 12 inadequately characterized and, as a 13 consequence, this chapter summary fails to 14 capture important distinctions in level of 15 causal association. A critical analysis 16 should review the number of studies available 17 on a topic, the strengths and limitations of 18 study design, data, and analyses, and the 19 distinction between short-term and chronic 20 lead exposure effects. Such a review is 21 necessary for a defensible causality 22 determination." CASAC should make similar

### 202-234-4433 Neal R. Gross & Co., Inc. Page 12 1 comments about the ozone ISA, as the majority 2 of these arguments apply. 3 DR. SAMET: Thank you. Any 4 comments? Okay. Thank you. And next, 5 Christopher Emery. 6 MR. EMERY: Thank you. Yesterday 7 there was a couple of comments made during the 8 review of Chapter 3 that I want to just 9 clarify on, one of them being something to the 10 effect models can't get small-scale details, 11 that they get the means okay but you don't get 12 a lot of detail. And, generally, I agree with 13 that statement, but I tried to stress 14 yesterday in my comments that there's a long 15 way to go before we reach the diminishing

16 returns. 17 You know, I want to make sure that 18 the non-modeling experts on the panel 19 understand that and don't take away the wrong 20 message that we're at the point where it's as 21 good as it's going to get because that's not 22 true. The modeling inputs are, you know, your

### 202-234-4433 Neal R. Gross & Co., Inc. Page 13 1 modeling is as good as your inputs, so you can 2 always add more detail into the inputs. You 3 know, the NAAQS SIP requires photochemical 4 modeling down to very small scales for the 5 State Implementation Plan, and that's all done 6 by EPA guidance so it's important to 7 critically review these models and not just 8 take them for granted. Thank you. 9 DR. SAMET: Okay. Thank you. 10 Questions? Comments? Okay. Mark Nicolich? 11 DR. NICOLICH: As you no doubt 12 recall from my testimony yesterday, I made two 13 points about the Kim paper, Kim et al. First, 14 the analysis was a two sample t-test on the

15 subset of the collected data and the 16 statistical results were dependent on which 17 analysis was used, and the second point was 18 that the published differences for FEV and FEC 19 were statistically significant but not 20 clinically significant. 21 I'd like to point out that these 22 same points apply to the Adams papers and to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 the EPA re-analysis of them by Dr. Brown. The 2 Adams data were collected with the interim 3 measures; and, based on conversations with Dr. 4 Adams, he had planned to have those as part of 5 the analysis. He recognizes the value of 6 these interim data. 7 As a statistician, I ask the panel 8 to please be very careful and critical of the 9 statistical results from these chamber studies 10 that you are considering, and I also ask you 11 to not be seduced by the p-value. Thank you. 12 DR. SAMET: Okay, thank you. 13 Comments, questions? Okay, thank you. And 14 last, Doug Blewitt. 15 MR. BLEWITT: Thank you. I'd like 16 to make some clarifying comments regarding 17 winter ozone that were made yesterday. These 18 have been observed in both Utah and Wyoming. 19 There really are three ozone seasons. There's 20 summer, spring, and winter. And the formation 21 of ozone in wintertime is a very unique 22 situation. You need a number of things to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 15 1 generate ozone. First of all, you need fresh 2 snow cover. Fresh snow cover provides the UV 3 reflection necessary to drive the 4 photochemical reactions, and it also reduces 5 the surface roughness, which reduces 6 mechanical mixing which inhibits plume 7 dilution. 8 The second thing is very stable 9 meteorological conditions, very low mixing 10 heights, 100-meter type lids which encourage 11 buildup of pollution. And associated with 12 this are very calm wind speeds. So we're 13 dealing with very calm wind speeds and stable 14 conditions. 15 The third thing is we need -- 16 DR. SAMET: Quickly. 17 MR. BLEWITT: Thank you. If 18 you'll let me finish in a few seconds, I will. 19 DR. SAMET: Go for it. 20 MR. BLEWITT: The third thing is 21 you need topography to trap the emissions in 22 a basin, and you also need local emissions.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 16 1 These conditions are being studied by, have 2 been studied by the state of Wyoming. They're 3 being studied currently in the state of Utah. 4 DR. SAMET: Okay, thank you. 5 Thank you. I think -- any questions or 6 comments? Okay. Thank you, all. I think 7 we'll talk about this. I mean, I think this 8 is our first go at this opportunity for 9 rejoinder. I will say, Vanessa, a minute may 10 be on the edge of what people actually need. 11 DR. VU: Well, I really think that 12 we allow 30 minutes, so depending on number of 13 speakers ask, so that's up to the discretion 14 of the Chair to allow the speaker to talk a 15 little bit more. So it depends on number of 16 speakers, so we can never anticipate how many 17 people wish to speak. So it's your decision 18 next time. It is not Jon's fault. We also 19 expected some exchange between the members and 20 the speakers. So, again, I mean, you know, 21 it's something flexible. 22 DR. SAMET: So let me propose, I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 17 1 mean, since we do have some time, and I will 2 say, watching everybody, a minute is a 3 challenge. I have been, perhaps, become 4 renowned as a harsh taskmaster on the timing 5 of these things, I think if we have the time 6 I think we can certainly allow it. But 7 there's further opportunity for discussion.

8 Fred? 9 DR. MILLER: Given all the 10 modelers that were presented, it should just 11 be E over pi or, you know, pi over E as the 12 number of minutes, which should be about 1.2. 13 So they could have a few more seconds, you 14 know. We've got to start laughter today 15 because we're dealing with a lot of topics, 16 and that was a poor attempt but, you know -- 17 DR. SAMET: It was. Okay. 18 (Laughter.) 19 MR. ALLEN: Well, I could ask what 20 gender is the female, you know. 21 DR. SAMET: All right. So let's 22 get back to working again. Thanks. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 we'll, I think, look at how to make this 2 additional public comment period as effective 3 as possible. So I think what we should do now 4 is go to the draft letter, which I want to 5 thank everybody for your hard work overnight. 6 I just did a little bit of sort of initial 7 editing. I think we only have it on the

8 screen. 9 So what we're going to do is go 10 through the clean version. I largely did some 11 editorial cleanup, and I haven't changed any 12 major messages. So let's start with sort of 13 the lead person on each of these taking people 14 through. So we'll start first with the 15 comments related to Chapter 3, Daniel. And 16 we're going to see if we can get the font size 17 a little bigger for those of us who are 18 optically impaired, challenged. 19 Let me ask, can everybody see okay 20 now with this version, roughly? Okay. Let's 21 leave it as it is and go ahead then. Daniel, 22 please.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 19 1 DR. JACOB: Okay. I tried to 2 synthesize a discussion yesterday in terms of 3 five bullets, which I think was a little bit 4 more than was asked for but this was a really 5 very long chapter. So the first bullet has to 6 do with a discussion of background ozone. 7 While overall very good, it has some 8 weaknesses. It's missing some important 9 papers, which, to be fair, were accepted for 10 publication after September 1st, so after 11 release of the second draft ISA. But, 12 notably, the paper by McDonald-Buller which 13 provides a state of science review of the 14 strengths and weaknesses of current background 15 ozone estimates, and also the Emery et al. 16 paper which provides an alternative 17 calculation of the PRB. The discussion in the 18 ISA needs to acknowledge better the difficulty 19 of models in capturing the high extreme of the 20 ozone distribution at remote sites since these 21 are often related to background ozone, 22 particularly in the mountainous west. The

### 202-234-4433 Neal R. Gross & Co., Inc. Page 20 1 discussion of welfare influences in ozone 2 seems rather uncritical, and more focus needs 3 to be placed on background estimates relevant 4 to the annual four highest ozone 5 concentrations. 6 Okay. That was the first bullet. 7 The second bullet is the discussion of 8 background ozone needs a better synthesis of 9 where we stand with regard to our confidence 10 in estimating this background, including 11 quantitative assessment of uncertainties. The 12 McDonald-Buller paper should be of particular 13 value here. It would be good to discuss how 14 the information from this chapter will be used 15 in the REA and PA and then make scientific 16 recommendations on the inputs to those 17 approaches. 18 Third bullet. I'm sorry. I'm 19 just reading the bullets, but I guess it's 20 because they don't show here. So I hope you 21 don't mind. 22 DR. SAMET: No, that's fine. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 21 1 I think why don't we just go through it, and 2 if anybody wants to stop at some certain point 3 as you go through why don't we do that to

4 comment? 5 DR. JACOB: Okay, all right. And 6 I should say also that those bullets reflect 7 heavy input from the other commenters in 8 Chapter 3, including -- 9 DR. GRAHAM: I have a practical 10 question because I have no scientific 11 expertise in this area. But is this level of 12 detail appropriate for the administrator's 13 letter to have, you know, citations that need 14 to be included? 15 DR. SAMET: No, this is the 16 response to the charge question. 17 DR. GRAHAM: Oh, so this is the 18 longer version? 19 DR. SAMET: Yes, this is the 20 longer version. 21 DR. GRAHAM: Oh, okay. 22 DR. SAMET: Right, right.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 DR. JACOB: Okay. So now I'm on 2 the third bullet. Long-term trends in ozone 3 over the U.S. warrant more attention than is 4 presently given. These trends are important 5 for accountability of emission controls, 6 background influences, and effects of climate 7 change. There's a lot of literature on the 8 topic besides EPA reports and the Cooper et al 9 study. There's a number of studies -- okay, 10 I won't bore you with this. 11 Discussion of differences and 12 trends for different quantiles of the ozone 13 distribution and different ozone averaging 14 times would be very useful. Trends and 15 frequency of exceedances of 60 and 70 ppd 16 thresholds would be particularly topical. The 17 roll-back model will require a number of 18 coefficients that are informed by the analysis 19 of the temporal trends and how the 20 distributions are responding to controls, so 21 examining those trends is of particular value. 22 All right. The first bullet is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 23 1 more discussion of the western oil/gas field 2 winter ozone scenario may be helpful in two 3 ways. We now have two known areas with high 4 winter ozone. Understanding there are 5 relatively few, and these characterized 6 precursor sources may add to our knowledge of 7 many aspects of ozone information relative to 8 those winter enhancements. 9 And, finally, some more discussion 10 of the value of satellite observations for 11 ozone and its precursors would be appropriate. 12 The limited discussion of satellite 13 observations is rather tepid. A more positive 14 spin would seem to be in order, given that 15 satellite measurements have demonstrated 16 usefulness for observing ozone in a free 17 troposphere and for providing top-down 18 constraints on NOx, CO, and VOC emissions. 19 So, overall, this chapter provides 20 a very good overview of the atmospheric 21 chemistry relevant to ozone pollution with the 22 ability of models to describe it and the ozone

### 202-234-4433 Neal R. Gross & Co., Inc. Page 24 1 concentration patterns over U.S., including 2 the background ozone; but it could be improved 3 following those five bullets. 4 DR. SAMET: So I think there's 5 some important issues to discuss here, and I 6 think your second bullet, if we can go back to 7 that one, I think is probably one of the most 8 critical issues in all of our discussion, and

9 that's the last sentence. There should be 10 discussion of how the information would be 11 used in the REA and PA, and this is a little 12 bit of our discussion yesterday. And I think 13 the answer right now is it's not clear exactly 14 how this chapter is going to feed into the 15 subsequent REA from our initial understanding 16 of what we heard yesterday, so this is not 17 maybe exactly the right way to put this. I 18 think this document, this chapter has to set 19 the stage for the REA. And, you know, somehow 20 I think there needs to be some consideration 21 because is it going to be, if we're looking at 22 total ozone risk, that's something different

### 202-234-4433 Neal R. Gross & Co., Inc. Page 25 1 from looking at concentration minus PRB, 2 however defined, or using total ozone risk, 3 and then I guess the question is what are the 4 scenarios above zero ozone that would be 5 selected for analysis around risk? 6 So we can bring a little more 7 clarity to our comments here because I think 8 what we have to say is that this document, 9 this chapter needs to provide the foundation 10 for the REA, whatever form that it may take. 11 And I think that that's a little bit 12 complicated. Will it be some attempt to 13 define PRB? And we've heard a lot about the 14 complexities of doing so. 15 So we've got to do a little better 16 than this sentence, and we have to sort of 17 allow for possibilities. So let's talk a 18 little bit about this. I think this is such 19 a key issue that I think we'll circle back to 20 this at the end when we talk about sort of 21 next steps. 22 So thoughts? Helen?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 DR. SUH: I think this also ties 2 into Chapter 2 and what's going to happen. Is 3 that going to be a summary really, or is that 4 going to be turned more into a synthesis? 5 Because if it becomes more of a synthesis of, 6 you know, it includes Chapter 3 and 4 results, 7 then perhaps these findings can be, the 8 findings from Chapter 3 can be brought forward 9 and then that Chapter 2 will set the stage for 10 whatever happens in the REA or the PA. 11 I guess I was thinking in some 12 ways because none of the chapters, I mean this 13 chapter and the exposure chapter doesn't 14 really have any conclusions or grand 15 recommendations traditionally. So perhaps it 16 is Chapter 2 that it belongs in rather than in 17 this chapter. 18 DR. SAMET: Yes. I mean, this 19 goes back a little bit to the discussion 20 yesterday where I commented about sort of the 21 lack of bottom lines in this chapter, and I 22 think you're really referring to the same

### 202-234-4433 Neal R. Gross & Co., Inc. Page 27 1 absence right now. And I think the question 2 is whether it goes into Chapter 2 as part of 3 an integration of how the story will be put 4 together or it sits here or both places. I 5 mean, that's -- 6 DR. SUH: Well, the thing is that 7 Chapter 3 is huge, right? And so the thing is 8 to distill all that information, even if you 9 have bottom lines after each section, it's 10 kind of tough because you want to bring 11 forward the most important information and use 12 the other information for background but 13 really bring forward the information that's 14 going to weigh in most in terms of the REA and 15 the PA. And so I think it's really hard to do 16 in such a massive chapter unless at the very 17 end of the chapter you have an overall summary 18 or synthesis or something. 19 DR. SAMET: Right, which is sort 20 of what was on my mind yesterday, in part 21 because it is such a massive chapter and 22 survey that it needs to come to some

### 202-234-4433 Neal R. Gross & Co., Inc. Page 28 1 conclusion. George? MR. ALLEN: Well, a 2 couple of comments. One, actually, there is 3 a very nice summary at the end of Chapter 3.

4 Well -- 5 DR. SAMET: But without bottom 6 lines. It's a summary, but it's not a 7 synthetic summary. 8 MR. ALLEN: Well, I'm not sure, 9 I'm not sure we have bottom lines out of this, 10 but that's a different discussion. But there 11 is, you know, there's a nice summary there. 12 Now, with something that's related to how you 13 might bring this material forward with or 14 without a bottom line to the REA and PA, one 15 question I have is we know that the ozone 16 background is not the same in different parts 17 of the country. Trinidad Head is maybe one of 18 the worst cases. So what do we do with, you 19 know, we have a rough estimate of how it 20 varies spatially. How do you, on a national 21 scale, how do you deal with that? It's a 22 question I have. You know, we have to deal

### 202-234-4433 Neal R. Gross & Co., Inc. Page 29 1 with it somehow, but, on the other hand, it's 2 not the same everywhere. Do we pick the 3 highest value and work from that? Do we pick 4 a median? That's a question that I just

5 wanted to throw out there. 6 DR. JACOB: But I think the 7 chapter does justice to that. It shows, in 8 particular, maps of background ozone values 9 that would show the higher values -- 10 MR. ALLEN: Right, right. And we 11 have that, and that's good. But going 12 forward, you know, if we're going to consider 13 background in some part of the process, it's 14 not the same everywhere. How do we apply that 15 to a national standard?

16 DR. SAMET: And how would that 17 figure into the REA, which is another -- 18 DR. JACOB: Right. But it does 19 figure into the REA. The background ozone 20 concentrations that are used are site specific 21 and season specific. 22 MR. ALLEN: Right. But the final

### 202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 NAAQS, of course, won't be.

2 DR. SAMET: Let's see. Fred? 3 DR. MILLER: I think you're 4 bringing up a very relevant point. And 5 whether the agency wants to or not, I think 6 they are going to have to get into the game of 7 regional standards, the same as the way that 8 PM is going to eventually, with the 9 heterogeneity of the things for the 10 coefficients, for effects and that. And this 11 is further complicated by total risk, so 12 you're going to say, okay, if I go with total 13 risk and I'm in an area where the Policy 14 Relevant Background is 06 and these are the 15 risks versus I'm out there berry-picking where 16 in the study with 0.04 they showed effects on 17 FEV1, which is clearly below the Trinidad 18 level background and that. And I think this 19 is setting the stage for that they're going to 20 have to look at some increment over 21 background, which is why I do not at all 22 understand the agency's desire to go to total

### 202-234-4433 Neal R. Gross & Co., Inc. Page 31 1 ozone risk. It does not make sense to me. 2 MR. ALLEN: You're actually 3 proposing a new form. 4 DR. MILLER: I think, eventually, 5 that's going to have to happen. And it's the 6 same way relative to the statistical aspect. 7 You know, the fourth came up with an analysis 8 by OAQPS of, you know, all that aerometric 9 data and that. And as this keeps creeping 10 down, it's going to force looking at the 11 statistical form of the standard more. 12 MR. ALLEN: Well, that's worth 13 keeping on the table for -- 14 DR. MILLER: And so I think, I'm 15 from Wyoming and I'll be damned if I want you 16 to have everybody in the world start to move 17 out there because the background level is 18 lower and we're talking about total risk, and 19 so this individual who thinks, oh, my children 20 have to grow up where they're exposed to much 21 less ozone, come to Wyoming. Forget it, you 22 know. First of all, you better get in shape.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 32 1 But my point is that we are, there is this 2 diversity in the contributions to the 3 background in different areas, and we're 4 getting down where there's no margin to move.

5 DR. SAMET: Ana?6 DR. DIEZ-ROUX: Yes. As a first7 time reader of this, I agree with Jon. I felt 8 that the chapter, I mean it's a very good 9 summary of the work, but it really needed some 10 sort of conclusion about what the relevance of 11 all this is for what's coming later. And I 12 think that can be part of the integrated 13 chapter that comes before, but I think that 14 the chapter itself would benefit from some

15 statement to that effect. 16 DR. SAMET: Okay. Others want to 17 comment on this? 18 DR. RUSSELL: I mean, if I might, 19 actually, they know how the information that's 20 going to be used in the REA and PA at this 21 point and it follows how it's been used in the 22 past. If they could actually work in, you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 33 1 know, sort of the idea that this information 2 is going to be used in the quadratic roll-back 3 model, this information is going to be used in 4 their BenMAP modeling, this information is 5 going to be used in APEX, and be much more 6 prescriptive and specific about what 7 information would be used and how. I think 8 that would be good, essentially saying these 9 are the constructs of the future use of this 10 information. And it's not just the background 11 question. It also has to do with the other 12 modeling results that they're going to use. 13 I think they could -- and the trend analysis. 14 And I think if they work the problem 15 backwards, that would be useful and 16 instructive, at least to us. Make 17 recommendations specifically about, you know, 18 we're going to use the results from this 19 analysis in this way in the PA and the REA and 20 this is what we recommend.

21 DR. SAMET: Helen? 22 DR. SUH: Well, actually, I don't

### 202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 know if you can do that because you're 2 basically then, you're giving them a roadmap 3 that they have to follow, right? So could you 4 just, would that be too prescriptive if you 5 said, well, this is going to be used because 6 then it kind of makes one group say to another 7 group this is how you're going to do it, and 8 what if there's innovation and differences 9 over time? 10 DR. RUSSELL: OAQPS, well, one, 11 they've done it before, and so you wouldn't 12 have to say this is how you have to do it, but 13 this is how -- 14 DR. SUH: You've done it before. 15 DR. RUSSELL: -- you've done it 16 before, and this is the information you should 17 use and why. 18 DR. SUH: So would that be in 19 absence of a summary chapter at the end of 20 this chapter or a synthesis and -- 21 DR. RUSSELL: It could still be -- 22 you know, in the health effects chapters, they

### 202-234-4433 Neal R. Gross & Co., Inc. Page 35 1 have the bottom lines written out, you know, 2 this is causal, this is likely to be causal. 3 You can do something very similar and say this 4 is the information that should be used and why 5 and provide the evidence for that. 6 DR. MILLER: Ted, I thought when 7 we discussed this before that it was more 8 along the lines that maybe three models are 9 presented and that there would be feedback, as10 well, this model has this strength over so11 and-so, and so it's pointing out those kind of 12 contrasts. Not saying use this model, but I 13 thought it was more the collective judgment of 14 when there are multiple options that you might 15 use which the panel or the experts in the area 16 thought would be the one that you should 17 consider the most. I thought it was on that 18 frame rather than saying you will do this. 19 DR. RUSSELL: I'm trying to make 20 it that this would be our recommendation and 21 why or maybe if they just said these are the 22 strengths. I could go either way. They don't

### 202-234-4433 Neal R. Gross & Co., Inc. Page 36 1 have to say you should use this and why, but 2 at least put the recommendation specifically 3 as to these are the strengths of this 4 approach, these are the strengths of this 5 approach, such that it's more clearly laid out 6 so that the policy people have a much clearer 7 idea of what path to take forward and why and 8 that we have a much better idea of what 9 information would probably be used. 10 DR. SAMET: Okay. A couple of 11 conclusions. The sentence up there is not 12 good enough, and I think what we need to say 13 and I think we should, you know, we're going 14 to have an opportunity to revisit the letter, 15 but I think these are going to be important 16 words. And I think what we could fairly say 17 is that the chapter provides a broad survey, 18 it covers the strengths and weaknesses of 19 different models, but that it should come to, 20 I think, a firmer, provide firmer guidance on

21 what should be done or what tools should be 22 used in the REA and that could be placed at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 37 1 the end of the chapter, where I think it might 2 most appropriately go. And if Chapter 2 3 becomes truly more integrative, same comments 4 might also go there. 5 I think, you know, we'll circle 6 back to this at the end of our discussions 7 this morning and maybe have a little bit of a 8 dialogue with the agency staff about this and 9 moving forward and sort of the building of the 10 REA on the ISA because I think all is not 11 clear yet and may not be until we see the 12 first draft of the REA. Yes, Joe? 13 DR. BRAIN: This seems like a 14 paragraph for the short letter to the 15 administrator. I mean, this is a really big 16 issue and this deals very well with, you know, 17 better, more accurate data, really taking into 18 account spatial and temporal variability. But 19 it really doesn't say how is it going to be 20 used, and I'm sort of echoing what others have 21 said, and how does it affect the 22 interpretation of clinical studies? So I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 38 1 think this is really a very big issue, and 2 somehow the agency and CASAC need to be clear 3 about what it means and how it will affect the 4 whole process. 5 DR. SAMET: Okay. No, I fully 6 agree and would certainly agree this needs to 7 be in the letter to the administrator. And 8 let's leave this second bullet and see if 9 there's just any comments. We have five 10 bullets on this response, so any other, any 11 other comments that anyone wants to make on

12 the draft? 13 Okay. So let's move down then to 14 the next chapter -- thanks, Daniel -- Chapter 15 4, which is -- 16 DR. SUH: I think that's me. 17 DR. SAMET: That's Helen, yes. 18 DR. SUH: Yes. Okay. So this 19 response is pretty short. So there's two 20 paragraphs. The first paragraph is a kudos 21 paragraph. It basically says what we like 22 about the chapter and what we think is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 39 1 particularly of note that they did a good job. 2 So the second paragraph gets into, proposes 3 some additional changes to the chapter that we 4 think are needed. And these were discussed 5 yesterday, and I don't think they're very 6 controversial at all. 7 But in any case, the first 8 proposed change has to do with including a 9 discussion of long-term ozone exposures, 10 acknowledging that the data are limited, but 11 the idea is to include the discussion, one, to 12 relate to the subsequent chapters on health 13 but also, and specifically, on how long-term 14 personal exposures relate to ambient 15 concentrations in forming the discussion of 16 exposure error and also to potential 17 confounding by co-pollutants. And so we just 18 acknowledged that there's not that much data 19 but proposed some solutions to how that might

20 be done. 21 So the second change that we 22 proposed has to do with Section 4.5.3, which

### 202-234-4433 Neal R. Gross & Co., Inc. Page 40 1 uses the APEX 03 model which is used in the 2 REA to model personal exposures. And in this 3 section, they used results from the model to 4 show how personal exposures would be changed 5 under various proposed, various alternative 6 NAAQS standards. And we proposed either that 7 they reconsider this section, rework it, or 8 delete it altogether. There were some issues 9 related to the plausibility of some of the 10 findings and also it seemed to be out of place 11 and maybe belongs in an REA rather than an

12 ISA. 13 Third, there was some issues 14 related to the section on population proximity 15 to ozone. Basically, we're just asking that 16 this section be tied more to the concentration 17 data because right now it's really a 18 discussion of populations living varying 19 distances from monitors, and so the idea was 20 to tie that to exposures better was to tie it 21 to the concentrations and perhaps that's a 22 good segue or tie to Chapter 3.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 41 1 And then the last one had to do 2 with synthesis and integration of exposure 3 results. I think, even though this is a very 4 good summary of the exposure results, it's 5 really not found in the rest of the document. 6 I think it really does speak to issues related 7 to exposure error confounding in these highly 8 exposed populations. And so it should, these 9 findings should be integrated within Chapters 10 2, 6, 7, and 8 in particular. 11 DR. SAMET: Okay. You or Jim, 12 somebody, we need to get that comment in about 13 just making certain that there's uniformity 14 and appropriate use of the terms exposure 15 concentration, dose, et cetera. Is that -- 16 you have some of that? Okay. It ought to go

17 here or there or both. 18 DR. SUH: I mean, we could add, I 19 could add a sentence in here about that. 20 DR. SAMET: Okay. This is 21 straightforward. Any comments on the draft 22 response? Joe?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 DR. BRAIN: Just one question. 2 How good is the document in terms of really 3 identifying which epi studies point solely to 4 ozone and how many are really contaminated by 5 inadequate attention to confounding, 6 particularly co-pollutants? 7 DR. SUH: I think that's actually 8 discussions that were in Chapters 6 and 7. 9 And I think this chapter didn't tie into the 10 epi at all, which I think actually could be a 11 criticism, actually, now that you mention it, 12 but also when they talk about those issues in 13 Chapters 6 and 7 they never really tie it back 14 to what was found in the exposure studies. So 15 there's really no tie whatsoever. 16 DR. BRAIN: Well, I'm not really 17 asking for discussion of the epi studies, but 18 I'm asking for exposure assessment, how many 19 really isolate exposure to ozone and how many 20 or to what extent is it a problem and has the 21 document adequately dealt with the issue of 22 confounding from co-pollutants, such as PM and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 other oxidizing -- 2 DR. SUH: Well, I mean, well, 3 maybe people who did Chapters 6 and 7 could 4 respond, but I think the thing is the problem 5 with the chapters now as they sit is there is 6 really no tie-in. The exposure studies that 7 are mentioned here are entirely separate from 8 the epi studies, save a couple of studies. 9 You know, there's only a very few. And then 10 the discussions of confounding in the epi 11 chapters are only about the epi studies 12 themselves using the ambient concentrations, 13 but they don't use the personal exposure data. 14 So I don't know if I'm answering your question

15 but -- 16 DR. SAMET: Actually, Helen, 17 doesn't this really speak the need for a 18 Chapter 2 that truly integrates? 19 DR. SUH: Yes, exactly.

20 DR. SAMET: That's what -- 21 DR. SUH: That's my pet peeve 22 about this whole document.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 44 1 DR. SAMET: I mean, I think that's 2 probably really the issue, Joe.

3 DR. SUH: Yes. And then that's 4 why I say these results are never carried 5 through or discussed in any way in any other 6 chapters where they're very pertinent. And 7 they could lend some plausibility to what's 8 found in the other chapters, so I think 9 either, I think actually not either but both, 10 they need to be integrated in Chapters 6, 7, 11 and 8, and also it needs to be somehow 12 synthesized better into Chapter 2.

13 DR. SAMET: Fred? 14 DR. MILLER: Well, Helen, I think 15 one of the things that Joe was getting at is 16 is there adequate treatment of spatial 17 variability and the appropriateness of using 18 a particular site monitor such as, for 19 example, in the PM situations of, you know, is 20 it close and given the heterogeneity of the 21 dispersion. So in this chapter, is there 22 enough information to judge that what kind of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 45 1 monitors and their distance from the 2 populations in the epi is reasonable, that it 3 was adequate? So I think that's the kind of 4 information that he's looking for in Chapter 5 4 that sets the stage for judging the epi. 6 DR. SUH: I see what you're 7 saying. I mean, I think a lot of it is there. 8 I mean, I think some of it could be done 9 better, especially with what you mentioned by 10 population proximity to the monitors. They 11 have some of it in Chapter 3, as well, in 12 terms of distance to roadway and their 13 impacts. But there could be some, definitely 14 some expansion and elaboration. But this sets 15 the stage in many ways for later chapters. 16 DR. SAMET: Well, the stage is 17 set. It's sort of like you have to do 18 chapter, like sort of introduce the authors of 19 Chapters 6 and 7 to the authors of Chapter 4. 20 I mean, I think -- 21 DR. SUH: It's entirely separate 22 really. I mean, even though, you know, like

### 202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 if the table is set but there's no silver -- 2 well, that's a bad analogy. But it's just 3 incomplete is what I'm saying. I don't think 4 it has to take much work to get to that next 5 place that it needs to be, but it's definitely 6 not there yet. 7 DR. SAMET: So, I mean, the 8 general point, and this may be part of what 9 goes into the letter to the administrator 10 would be the need for integration, and this is 11 illustrative. That integration could be12 accomplished in several ways, by better cross13 referencing from Chapters 6 and 7 to Chapter 14 4; and possibly a better Chapter 2, which is 15 something we'll have an opportunity to 16 discuss. Sverre? 17 DR. VEDAL: Yes. I mean, the 18 missing link is, and it gets to both Fred and 19 Joe's comment, is what is the impact of

20 measurement error on the health effect 21 estimates? I mean, there's a lot of 22 discussion about measurement error in that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 47 1 chapter. You know, the obvious differences 2 between central site or ambient measurements 3 and personal exposure, but the bottom line is 4 really what the impact of that is in the 5 health effects analysis. And, you know, it's 6 a tough nut. You know, it arguably should be 7 here or somewhere. Certainly, in Chapter 2 it 8 needs to be there because it is central to the 9 epi studies. 10 DR. SAMET: Okay. Other comments 11 on Chapter 4? Okay. So, Jim, we'll go to 12 Chapter 5. 13 DR. ULTMAN: So the first 14 paragraph just points out that there have been 15 significant improvements since the last draft, 16 but there remains further improvement in some 17 of the areas that were discussed before. And 18 there's really three items here. The first 19 one is what we discussed about the inclusion 20 of MOA in the chapter, and some of the 21 panelists felt that this wasn't a natural 22 thing to do and had suggestions for what we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 48 1 might, how it might be taken out of the 2 chapter. But my reading of the chapter was 3 that it's pretty ingrained in the chapter. 4 The beginning of the chapter is on dose of 5 ozone, uptake of ozone. The second part of 6 the chapter is the MOA. But then there's two 7 other parts of the chapter, one on 8 intersubject variability and one on species 9 homology and interspecies homology. And both 10 of those sections weave into it the effects of 11 both dose and MOA on those subjects. 12 So as I see it right now, it's 13 pretty integrated in the chapter, so I'm not 14 recommending that it be taken out at this 15 point but, rather, that the authors are just 16 careful to continue to strive to integrate 17 this with Chapters 6 and 7 on the health 18 effects, in other words to link it to the 19 health effects. I'm interested to hear what 20 the other panelists have to say. 21 The second major point that I had 22 was that the dosimetry -- I'm sorry. The

### 202-234-4433 Neal R. Gross & Co., Inc. Page 49 1 second point was what we brought up before, 2 that there's kind of an absence of consistent 3 definitions of the various dose metrics that 4 are used in the chapter. And this was pointed 5 out before, and there's been an effort made to 6 improve, as I said before, but it still needs 7 a lot of work. And this affects the exposure 8 chapter, too, but actually measures of 9 exposure are different than measures of dose. 10 So, hopefully, when they work on these two 11 chapters that they'll recognize this and 12 they'll be clear on what's an exposure metric 13 in their mind and what is a dose metric. 14 Then the last point has to do 15 with, the last point has to do whether it's 16 ozone or toxic products of ozone which are 17 causing damage. And in my mind, this is a 18 really critical issue. It's probably caused 19 by both, but it's really a critical issue 20 because, in terms of understanding and 21 analyzing dose response, eventually you have 22 to understand, you know, what chemicals are at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 the basis of this dose response. 2 Also, in choosing a dosimeter, it 3 depends on whether it's ozone or its reaction 4 products that are causing the damage. For 5 example, if it's only reaction products that 6 cause the damage, then maybe all you have to 7 know is the total amount of ozone that's 8 absorbed from the gas phase into the liquid 9 lining layer because maybe all of that is 10 converted into products and that's what's 11 causing the damage. On the other hand, if 12 it's ozone itself, we know that not all the 13 ozone reaches the epithelial cells because of 14 the reactions that occur in a liquid lining 15 layer, much of the ozone, perhaps most of it, 16 will be taken up there. So better dosimetry 17 there would be the tissue dose, how much 18 reaches the tissue. So the selection of which 19 dosimeters to use and how to explain and 20 analyze dose responses or model dose response 21 curves, that's tied into understanding what's 22 actually causing the damage to cells and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 51 1 what's causing the health effects. 2 And this chapter tends to 3 emphasize the reaction products as being more 4 important than ozone itself, which is okay if 5 that's what the authors believe because nobody 6 really knows at this point. But I think 7 what's missing from the chapter is discussion 8 of the factors that contribute to which of 9 these two are going to be more important. And 10 probably the most direct way of handling that 11 is that there is kind of a seminal publication 12 which models the reaction and diffusion of 13 ozone through the liquid lining layer. Pryor 14 was the first to publish that model, but it's 15 been published in different ways in different 16 places. 17 And by presenting the model, at 18 least within the text, by explaining the 19 model, what the elements of the model are, and 20 what the assumptions in the model are, if that 21 were explained in the text, then it would form 22 a platform or foundation to discuss whether it

### 202-234-4433 Neal R. Gross & Co., Inc. Page 52 1 might be ozone or it might be the products 2 that are causing the problem. And that can be 3 taken in the context of the discussion on 4 reactions and rates of reactions of different 5 materials which are already in the chapter. 6 And as Fred Miller pointed out, 7 there is literature, there's more than one 8 article where measurements of the liquid 9 lining layer have shown that there are very 10 thin layers, almost dry spots in the liquid 11 lining layer. So if you look at one of the 12 parameters in the model, which is the 13 thickness of the lining layer, one could argue 14 that, if those articles are correct, then 15 there are points in the liquid lining layer 16 where it's very dry and where you are going to 17 get focal damage occurring. So I think there 18 needs to be a richer discussion of this in the 19 chapter. 20 And that's about it. Now, these 21 are just the major points. There were a lot 22 of technical points, as you can imagine, in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 53 1 the individual comments, and I didn't bring 2 the rest of those forward. But, again, I'd 3 like to hear if the other panel members feel 4 that there are other things that should be in

5 here. 6 DR. SAMET: Okay, great. Thanks. 7 And just one comment on the organization. I 8 mean, I think we talked about many 9 alternatives yesterday. I don't think there 10 was a strong view for one or another but just 11 probably, I think, as you say, that it can be 12 done as it is but probably needs to be better 13 explicated what's going on in the chapter. 14 I did want to ask, though, and, 15 Steve, your reflections on the gene 16 environment interaction materials and whether 17 that should be pulled out because it seems to 18 me that gene environment interactions might be 19 useful if they provide understanding of mode 20 of action, but I don't think the text that's 21 in there is at that level. It's rather 22 descriptive and might be moved into the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 Chapter 8. 2 DR. KLEEBERGER: Right. So I 3 think, as Jim has described it, because it 4 integrates well with Chapters 6 and 7 also 8, 5 I think I would suggest we keep it there. You 6 know, that's what we're sort of looking for is 7 how we can better integrate all the chapters, 8 and that provides I think some sort of a basis 9 for doing that. So I think I would advocate 10 now to keep it there. 11 DR. SAMET: Okay. Other comments? 12 Judy? 13 DR. GRAHAM: Yes, I think this is 14 a good first draft. I might offer a couple of 15 suggestions. Oh, one is something that we 16 could consider adding, and that goes to the 17 definition of exercise. I think that the 18 chapter as it is, you know, gives a lot of 19 good details about the impact of exercise, but 20 what's important in the following chapters is 21 exercise is the deal breaker on whether you 22 get effects at ambient levels. And so the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 55 1 whole issue of what is moderate exercise, what 2 is heavy exercise? 3 So I think that exercise probably 4 is very important because of how it affects 5 the dose. So I think if there could be a 6 richer explanation in the dose chapter about 7 the importance of exercise and the definition 8 of moderate, the definition, you know, the 9 definition in English terms, such as heavy or 10 is it brisk walking or is it jogging? I think 11 that would provide a much stronger support for 12 what comes later in the human clinical study 13 discussions. 14 The other comment I might have is 15 that, well, I'll just say it. I have to take 16 exception to how this basically lauds them for 17 the discussion as it relates to interspecies 18 similarities and differences and homology.19 And I think that this chapter says animal-to20 human extrapolation, that the cup is two21 thirds empty. And I'd be willing to accept 22 that the cup is half empty, but my preference

### 202-234-4433 Neal R. Gross & Co., Inc. Page 56 1 is the cup is two-thirds full. 2 As I said yesterday, I don't want 3 to belabor this point, but the animal 4 toxicologist tells us things that we can never 5 find in humans. And it tells us about some of 6 these lung structural effects which some have 7 said are akin to what's happening with young 8 cigarette smokers. So that story isn't 9 brought out, but even if the story is brought 10 out in the later chapters so what? It's the 11 extrapolation. So I think there needs to be 12 a stronger positive statement here clarifying 13 that qualitative extrapolation is very 14 strongly supported. Quantitative 15 extrapolation still has miles to go, but 16 there's still reason to believe in it. 17 I think that the whole 18 extrapolation -- even the section on 19 extrapolation is not even labeled 20 extrapolation. So you don't even, from the 21 title of the section, you don't even get that. 22 So I would strongly urge beefing up the whole

### 202-234-4433 Neal R. Gross & Co., Inc. Page 57 1 area of animal-human extrapolation. 2 As a third point, I guess where it 3 says some CASAC members wanted a different 4 organization. I guess I don't care for that 5 language unless we really explore it. I mean, 6 this is supposed to be a consensus group. I 7 was one of the people arguing for it being in 8 the MOA, having the MOA in this chapter be one 9 more in terms of biochemistry and molecular 10 level and then like the MOA for pulmonary 11 function or the MOA for information being in 12 later chapters. I mean, I'm willing to 13 concede on that point. To a degree, in any 14 organization, if it's well written, it could 15 go anywhere. I mean, it would be silly to put 16 it in the atmospheric chemistry section, but 17 if it's well done it theoretically could be 18 there. So I would, I don't know who else was 19 recommending that, but I'd be willing to 20 withdraw that in order to reach consensus. 21 DR. SAMET: Thank you. Yes, Joe? 22 DR. BRAIN: I agree. I think this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 chapter is really about the, you know, the 2 amount of dose of ozone and its anatomic 3 distribution. So I think exercise is really 4 a big deal. I also think, you know, we need 5 not only information about what kinds of 6 activities correspond to different levels of 7 inhalation but what do we know about the 8 activity levels in the United States, indoor 9 versus outdoor, what levels, children? 10 And, Jim, I'm fascinated by the 11 question of, you know, is it ozone or reaction 12 products, but I don't really see it as either 13 being answerable or very necessary here. You 14 know, at this nano scale, whether it's ozone 15 on either side of a very thin barrier, we 16 really don't have the tools to answer that. 17 And it's like for PM. You know, is it the 18 particles, it is the metal in the particles, 19 is it reactive oxygen species? Which one we 20 don't know or we know a little but not enough, 21 but that really doesn't affect our dose 22 response estimates.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 59 1 So I guess I'm a little less 2 enthusiastic about this last paragraph. I 3 don't really see clarity as being possible or 4 necessary. 5 DR. SAMET: Jim, do you want to 6 respond to that? Because you felt a little 7 more passionate about this I think. 8 DR. ULTMAN: Well, I guess I was 9 seeing this as a critical area for people to 10 be aware of, not necessarily that we can do 11 something about it at the moment. But it's a 12 critical blind spot that we have which affects 13 our perception, at least in dosimetry, which 14 affects our perception of what is important in 15 describing dose and in forecasting dose. So 16 as I said, I see it as a blind spot, and Joe 17 is seeing it more as, I think, well, how is it 18 going to be applied in later chapters kind of 19 a perception. 20 DR. BRAIN: I'm more interested in 21 the anatomic distribution of dose. You know, 22 is it big airway, small airways, where are we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 60 1 likely to see long-term remodeling, and how is 2 that influenced by exercise? It seems to me 3 that's an important issue because it then 4 helps us to understand what kind of disease 5 outcomes we might expect. But whether it's 6 ozone, per se, or reaction products, you know, 7 at a scale of 100 nanometers, I don't see that 8 as having the same implications or utility. 9 DR. SAMET: I think both Mike and 10 Fred want to weigh in, so why don't we do it 11 in that order? Mike, go ahead. 12 DR. FOSTER: So I have to support 13 some of what Jim is saying, Joe, because 14 presently the controlled laboratory studies in 15 humans, without having to extrapolate, it's

16 translated late to the human. You collect 17 bronchoalveolar lavage fluid, you do proteomic 18 analysis on that, you do it within a subject, 19 you do it within a disease group, you do it 20 within a group that does or does not have a 21 polymorphism related to surfactant proteins, 22 for example. That information is valuable for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 61 1 telling us something about susceptibility and 2 mechanism of action of inflammation. You're 3 not going to get that without extrapolating 4 from some of the animal models.

5 DR. SAMET: Fred? 6 DR. MILLER: Well, I want to just 7 bring up several points that actually amplify 8 what Jim is getting at. The models that we 9 developed and predicted 15 years later with 10 1803 in primates Hatch and Plopper published 11 and they have taken away the mucus layer and 12 the surfactant layer and they have a plot of 13 the tissue dose of ozone as a function of 14 generation and it's a mirror image of what we 15 showed in our 1985 publication for the tissue 16 dose in humans. Analogously, in the '95 paper 17 with Mercer and looking at the damage in the 18 alveolar region, the wall thickness as a 19 function of distance from the bronchoalveolar 20 duct junction in rates over a 450-micron 21 increment has a mirror image of the tissue 22 dose predicted by the mathematical models.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 And a third point, the point that 2 I made yesterday about in the document now it 3 talks about, well, it's just net tissue dose. 4 And if that were the case, in terms of the 5 damage in the tracheobronchial region, you 6 would see as much, which you don't. 7 And so I think in response to Joe, 8 there are some things where it probably 9 doesn't matter, which is in terms of the 10 amount in the given region as a function of 11 what that thickness layer is a composite of, 12 and that's a big difference between the mucus 13 layer and the surfactant layer, which the 14 surfactant, in addition to being thin, has 15 extremely small amounts of material that can 16 react with ozone. Most of them are saturated 17 fatty acids, not unsaturated. And ozone

18 cleaves double bonds. 19 So some of this would help amplify 20 what Mike is talking about, as you've looked 21 at your ability to manipulate, you know, with 22 different animal models and that, components

### 202-234-4433 Neal R. Gross & Co., Inc. Page 63 1 of these animals, in addition to the aspect of 2 the restructuring, which I think, I agree is 3 probably one of the most important findings in 4 the animal models and it's then taken to 5 human. And that's why yesterday I argued just 6 give me one example of quantitative 7 extrapolation, which I've already done and 8 published in '88, and guess what? It was the 9 tissue dose, it wasn't the net dose, that 10 showed this perfect relationship amongst the 11 different species once all the things were 12 normalized. 13 So I have to say there's been too 14 much emphasis on that we can just go ahead and 15 compute C V dot E three times t for humans 16 and, therefore, we go on with our standard 17 setting. The importance of the animal data 18 brought in to shore up why these smaller 19 changes in clinical studies have great 20 implications for large populations if exposure 21 is shored up by the animals. 22 DR. SAMET: So perhaps this is a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 64 1 matter for the need for integration. I think, 2 looking again at what you've written, Jim, I 3 think it would be helpful to say why this, in 4 the end, is important, and I think that's 5 probably what's lacking in the comment. And 6 I think Fred articulated it pretty well. 7 DR. ULTMAN: Yes. To summarize 8 it, I would say, and I think to summarize what 9 Fred said, I would say the dose distribution 10 that the model predicts depends on what's 11 causing the damage because different materials 12 will have different dose distributions and -- 13 DR. SAMET: And this is relevant, 14 in part, to interpretation of doses across 15 species and so on. I mean, just sort of tie 16 the whole thing up a little bit better both in

17 our comments and then also to make a 18 recommendation that the chapter really needs 19 to do that, too, which I think is part of the 20 story. And then Judy will be happy. 21 DR. ULTMAN: On the exercise 22 statements, I do agree it's important to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 65 1 define exercise carefully. And since the last 2 draft, there's been additional material put in 3 on the response of frequency and tidal volume 4 and minute volume to exercise. So there has 5 been a movement toward clarifying exercise, 6 but I don't know how far really it should go 7 in this chapter because this is a chapter on 8 dosimetry because, you know, the suggestion 9 was made, I think Joe made it, that we should 10 have information on modern activity of people 11 across the country. I mean, does that go in 12 a dosimetry chapter or is that an exposure 13 issue? Should that be something that is tied 14 into more directly to some of the short-term 15 and long-term health effects chapters? 16 DR. GRAHAM: You raise two things 17 there, Jim. Okay. One, let's talk about the 18 exercise levels. I think at issue here what 19 goes to the administrator is the big deals, at 20 one level saying insert a table that shows the 21 relationship of V dot E to jogging or that 22 sort of thing so that later chapters have

### 202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 something to rest on. I could think of that 2 as just a detail. It's one small comment. 3 But I think it's a huge impact comment to have 4 that there. Indeed, you're right that one of 5 the greatest improvements in this chapter is 6 to describe the impact of exercise on 7 dosimetry, but you can't look at that and know 8 whether a particular V dot E on one of the 9 additional figures, which I think are great,

10 what does that mean? How do I translate that 11 to what I'm going to say in the human clinical 12 chapters? So it's small, but it's a big deal. 13 And I think the other is more 14 towards activity patterns. I was struggling 15 when Helen was presenting that should I make 16 that comment there that they need to have more 17 activity patterns. But, you know, one of my 18 detailed comments is they should have some 19 model runs to get an idea of like age-wise 20 what are people doing. So I think the 21 activity patterns would be more proper in the 22 exposure chapter, and then the only argument

### 202-234-4433 Neal R. Gross & Co., Inc. Page 67 1 in my head is to what degree does it rise to 2 the level of the administrator? It needs to 3 be better off in the document.

4 DR. SAMET: Let me ask are there 5 other comments from anyone? And then, Jim, is 6 there anything here that actually you would 7 see as critical to highlight in the letter to 8 the administrator? I'm not sure I do. I'm 9 not sure I actually do. 10 DR. ULTMAN: I think the last 11 letter there was nothing really about the 12 dosimetry chapter. 13 DR. SAMET: Yes. I mean, the 14 general integration issue certainly applies to 15 this chapter, and we'll emphasize that. Okay. 16 Why don't we move on to Chapters 6 and 7? 17 Sverre, do you want to take us through this 18 since Michelle had to go on? Sverre, put your 19 mic on. 20 DR. VEDAL: I saw this this 21 morning, so I'll just reiterate what Michelle 22 has written and I'll take the prerogative of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 68 1 making my own editorial comments. So the 2 first one is kudos. The second point -- let's 3 see. Oh, the second point is one of our 4 contentious points, this issue that we 5 discussed yesterday about how much of the old 6 findings we should incorporate into the 7 current ISA. And the point is made here that 8 key studies that existed should still be 9 discussed, etcetera, etcetera. 10 So I think, I mean, I think this 11 is a little bit of a tempest in a teapot 12 personally. I think, you know, the way that 13 ISA is currently could be modified a little 14 bit by perhaps drawing attention to the very 15 critical studies, although they were already 16 mentioned there but perhaps not highlighted. 17 I would resist a description again of the 18 critical studies as has been done in previous 19 ISAs and criteria documents. I think perhaps 20 incorporating findings into a table to allow 21 comparison is perhaps not a bad idea. 22 I think Helen's point yesterday is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 69 1 the telling point about what we're doing here. 2 We really need to draw our attention to 3 whether we're going to change the 4 categorization of causation based on recent 5 evidence. And in order to focus on that, we 6 need to know what has happened since. I think 7 it is a good point to be standard about what 8 we mean by since so that a very standardized 9 approach became what is new and old is a good 10 point and, you know, leave it at that. I 11 think we've had a lot of discussion in the 12 past about the size of the ISA and the 13 criteria document, and I think that was a 14 valid point and I think the EPA has been 15 responsive to that. 16 The second point is, there's 17 another one I'll take some exception with. So 18 the second part is making the point that we 19 have studies suggesting a causal relationship 20 between mortality and whether we should 21 consider moving the causal category from 22 likely to be causal to causal for ozone and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 mortality. This is entirely based, to my 2 mind, on time series studies which, on the 3 face of it, seem to be analogous to all the 4 myriad of time series studies we have in the

5 PM world. 6 There are some differences. We 7 have this huge exposure issue in ozone that's 8 much more acute than it is for PM, that is 9 this exposure disclassification issue. 10 Secondly, we don't have the corroborative data 11 from other lines of inquiry that we had for PM 12 to shore up the time series studies. So I 13 would resist moving this into the category of

14 causal. 15 The point about short-term and 16 long-term exposure is a good one. This is to 17 be actually a little bit more, in terms of 18 organizational issues, not to contaminate the 19 discussion of long-term exposure with 20 including short-term findings and, likewise, 21 the short-term section should not be 22 contaminated by findings where the studies

### 202-234-4433 Neal R. Gross & Co., Inc. Page 71 1 have intended to look at long-term effects. 2 The standardized exposure 3 increment point is a good one. And the next 4 paragraph, again, the issue of really just 5 focusing or restricting the discussion to 6 peer-reviewed literature is there. There's 7 the point about biological mechanisms that was 8 made. And then, yes, the issue of the human 9 clinical studies is here. 10 Actually, I'm sorry I didn't bring 11 this up as a point yesterday because it did

12 reflect a lot of what I saw was the tenor of 13 the discussion and I think it's going to end 14 up being a very big point. As all of you 15 will, as most of you will recall, it was the 16 human clinical studies and, in particular, the 17 acute lung function response in those studies 18 that played such a central role in our 19 discussion about the level of the standard. 20 What I've heard in the discussion this time is21 those findings are, we should think about de22 emphasizing those findings in some sense in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 72 1 terms of the clinical relevance of them and 2 the population health relevance of them. 3 That's going to be a big deal in terms of 4 thinking about when we get to the next stages, 5 particularly the policy assessment, if we 6 change the focus from that emphasis. And we 7 probably will need to have to come back to 8 that in deliberations -- 9 DR. SAMET: So just a 10 clarification. Do you read this as saying 11 that they should be de-emphasized or just that 12 there should be consideration to -- 13 DR. VEDAL: No, no, no, no, no, 14 that's a point that I'm making that we haven't 15 discussed in any detail but I think is a point 16 that we're going to have to grapple with. 17 But, no, that's not here. What is here is 18 really this issue of, you know, is being a 19 little bit more clear about the implications 20 of the clinical studies, and we talked about 21 that, you know, a little bit. 22 The one thing that I would add

### 202-234-4433 Neal R. Gross & Co., Inc. Page 73 1 because I think that EPA needs to do a better 2 job on is one point that I brought up 3 yesterday about respiratory symptoms and 4 medication use in asthmatics. You have two5 options there. You can't just take the knee6 jerk approach and say things are, it's7 business as usual. You either have to pooh8 pooh the more recent studies that were done, 9 in particular the multi-city studies, and not 10 put much weight on them, or you're going to 11 have to change your assessment or bottom line, 12 one or the other. But you just can't say it's 13 business as usual based on the recent data. 14 DR. SAMET: Okay. Comments? I 15 have a few, but let's move this around. Ted? 16 DR. RUSSELL: I'm not sure you're 17 the one to ask or whatever, but one of the 18 comments that's made is that the ratio among 19 the daily 24-hour average, daily 8-hour 20 maximum, and daily one-hour maximum should be 21 consistent in the ISA. One concern, that 22 ratio changes by city and time period that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 you'd be looking at, and I'm not sure what 2 you're looking for or what anyone is looking 3 for in this case, not being that familiar with 4 how it changes within the chapters. I'm 5 worried about making that statement unless we 6 think it's been, those ratios have been 7 changed inappropriately. 8 DR. VEDAL: Yes. I mean, I think 9 what she's getting at here is -- yes. I mean, 10 right, it's a complication, but what she's 11 getting at here is studies where you present 12 only one metric and how to convert that to 13 another metric so studies are comparable. 14 DR. RUSSELL: Right. But I'm not

15 sure I'd make -- 16 DR. VEDAL: Maybe it's an 17 oversimplification. 18 DR. RUSSELL: Yes, I'd be worried 19 about making that statement so boldly. I'd 20 let EPA determine what they think is the 21 appropriate ratio. 22 DR. MILLER: I don't think that's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 75 1 what's meant here. It's meant provide more 2 description so that you have what this dose 3 ratio is for that particular study and the 4 averaging time and that so you can understand 5 some differences that come up between 6 epidemiological studies and results. It's for 7 interpretation. I don't think it's to say 8 that you can pick one and say -- I viewed it 9 more as providing better information to 10 understand the effects that you observed. 11 DR. RUSSELL: I think really it's 12 an issue of standardization, just to be 13 consistent throughout the discussion rather 14 than just something, you're saying something 15 loose like standardized increment or using 16 different ratios at different settings but 17 just to be standard throughout the discussion. 18 DR. SAMET: Helen, microphone. 19 DR. SUH: I think this refers in 20 meta analyses when one study uses, you know, 21 one hour, one uses eight hour. They use just 22 a multiplication factor. But the thing is is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 76 1 that does ignore geographical variation in 2 those ratios, but they've always just applied 3 a standard. I think it's okay as long as 4 there's some explanation. So they say, well, 5 we use this but it doesn't acknowledge 6 geographic variation discussed in Chapter 3 or 7 whatever that might be. But I think in the 8 epi studies there traditionally has been a

9 standard value. Isn't that true? 10 DR. SAMET: Very often. I think 11 what you're really saying is that greater 12 clarity is needed in the text on what has 13 actually been done. I think we could reword 14 that. Go back to the one -- I'm sorry, Ana.

15 Go ahead. 16 DR. DIEZ-ROUX: I had a question 17 about how well you guys think this chapter 18 kind of highlights the evidence of health

19 effects below the current standard? Because 20 it seems to me that that's an important issue, 21 and it wasn't clear to me from a quick read of 22 these chapters that that was really brought

### 202-234-4433 Neal R. Gross & Co., Inc. Page 77 1 out in a systematic way. 2 DR. VEDAL: Well, I thought it 3 did, but it may be because I just assumed it. 4 I mean, essentially, a lot of the epi evidence 5 is essentially at or below the current 6 standard. And I think that point was made, 7 perhaps not highlighted as much as it needs to

8 be but - 9 DR. SAMET: Steve? Okay. 10 DR. KLEEBERGER: So, Sverre, I 11 appreciated your comments on the third point. 12 I think that was the mortality in ozone 13 exposure and whether it's likely or causal. 14 So what exactly are we going to be saying now? 15 I mean, you've expressed some concern about 16 making a statement that it is causal. 17 DR. VEDAL: No, I'm saying we 18 should agree with the EPA's current -- 19 DR. KLEEBERGER: That it's likely? 20 DR. VEDAL: -- designation that 21 it's likely a cause, yes. 22 DR. HARKEMA: I don't think that's

### 202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 what their discussion was about on that third 2 one. I don't think we discussed that bullet. 3 I would change it to this. The discussion was 4 under short-term exposure of ozone the EPA 5 should consider changes and the conclusion of 6 the cardiovascular effects to likely to be 7 causal relationship to be consistent with the 8 conclusion for the cardiopulmonary-related 9 mortality. So it wasn't to bring up the 10 mortality up to causal, but it was to make it 11 in line with the cardiovascular effects. 12 DR. SAMET: Okay. So why don't we 13 wordsmith it? Okay, thank you. Judy? 14 DR. GRAHAM: A couple of points. 15 One, to directly answer Ana's question about 16 do these chapters sufficiently talk about 17 what's happening under the current standard, 18 I think this last bullet here, additional 19 descriptions of human clinical studies, that 20 will beef up the discussion of inflammation 21 because there are effects being observed at 22 very low levels. So I think that that will

### 202-234-4433 Neal R. Gross & Co., Inc. Page 79 1 help you in that quest. 2 There's one paragraph here that I 3 especially like. I've had a lot of angst over 4 the artificial division between old and new, 5 between what's in tables, what's not there, do 6 you have to have three documents piled up to 7 read this? So I've had a lot of angst over 8 that. I thought that the way that this 9 paragraph was written was quite good. I 10 thought it was a compromised position and, 11 hopefully, provided enough guidance to EPA of 12 how to go through the water on we do need to 13 know have the previous conclusions changed or 14 been substantiated but have the previous 15 conclusions, what are the previous 16 conclusions? So that is the old data. So I 17 think this paragraph provides an excellent 18 guidance. 19 The only thing I would add to 20 what's there is there needs to be a much 21 stronger or fuller discussion of pertinent 22 animal toxicology. In particular, I refer to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 80 1 the lung pathological studies, especially in 2 monkeys but also rats, mice, dogs have similar 3 effects, which gives more credence to the 4 findings. But like the word bronchiolitis is 5 not there. Maybe some of these things might 6 be buried in a table. Bronchiolization 7 changes are not mentioned or Type 1 cells are 8 not mentioned. So if words like, you know, 9 morphological changes, that's fine as far as 10 it goes. But what are they? Should we care

11 about them? 12 So I'm not talking about an 13 additional 20 pages. I'm saying that these 14 adjectives of morphological changes, I mean so 15 you get interstitial thickness increase? So 16 what? There's answers to this. So it doesn't 17 have to be ten pages but to bring this out as 18 a whole class of effects, particularly in the 19 chronic chapter but a little bit in the acute 20 chapter, I think will add to the whole basis 21 of the NAAQS. 22 DR. SAMET: So, Judy, maybe you

### 202-234-4433 Neal R. Gross & Co., Inc. Page 81 1 should write a paragraph and send it? I mean, 2 I think that would be helpful. Fred? 3 DR. MILLER: I want to go back to 4 Chapter 5 at some point, so let's finish this.

5 6 DR. SAMET: Finish this. Anybody 7 else on Chapter 6 - 7? Mike, anything you 8 want to add? No? You know, it seems to me 9 that this general concern about integration 10 applies here, as well. I mean, I think that 11 a lot of the comments are directed to that. 12 What about things -- what are the key points 13 that go, that are sort of advanced into the 14 letter? Yes, Helen? 15 DR. SUH: I didn't talk about it 16 yesterday, but I was wondering, you know, one 17 of the big things in the exposure chapters is 18 about these ratios of the personal to ambient 19 and this idea about does ozone, is it a marker 20 for itself in terms of health effects or is it 21 a marker for all oxidants in the atmosphere? 22 And then so if you have these low ratios of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 these personal exposure to ambient 2 concentrations, and then you talk about the 3 concentration response relationships comparing 4 from controlled laboratory to the epi and sort 5 of what does that mean in terms of the 6 perceived toxic effect of ozone? Do you 7 understand anything -- I'm not sure it's

8 clear. 9 DR. VEDAL: Well, I mean, I have 10 my own notion about that. The only way I can 11 understand the human epidemiology is by indoor 12 reaction products but, you know, I -- 13 DR. SUH: But do you think it's 14 discussed here and then should it be, or is 15 that more for an integration kind of chapter?

16 17 DR. VEDAL: It's an integration 18 thing. I mean, to me, it's partly exposure. 19 It's an exposure issue, and we know very 20 little about, I mean in terms of health 21 effects, we know very little about -- 22 DR. SUH: But it is a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 83 1 concentration response, you know, it really 2 does speak to that, as well, in terms of 3 comparing the controlled laboratory to the epi 4 study results and the different curves and -- 5 DR. VEDAL: Yes, I don't know. I 6 mean, to my mind, it's a little bit, you know, 7 like Joe's point earlier, whether it's ozone 8 or something like it, you know, you're still, 9 if you're measuring ozone as the exposure 10 you're measuring that as a sort of 11 concentration response function, and what the 12 mechanism of the actual effect is kind of, in 13 some sense, a secondary question. 14 DR. SUH: So I guess, so you don't 15 think it belongs here so much or -

16 DR. MILLER: There should be some 17 clarifying aspect here, and that is, you know, 18 ozone has been used as an indicator variable 19 for ozone and other oxidants, okay? And the 20 genesis of that has clearly been in past CASAC 21 reviews interpreting the field camp studies 22 where you have in children bigger effects than

### 202-234-4433 Neal R. Gross & Co., Inc. Page 84 1 what you see in controlled chamber studies and 2 the argument being that you're talking about 3 oxidants in general. So my understanding has 4 always been that it's ozone, but it's an 5 indicator variable for ozone and other 6 oxidants. And so I don't think any evidence 7 has come forward to change that, but I'm not 8 sure. Are you saying that none of that kind 9 of discussion is in the health chapters? 10 Because it clearly has been in past documents.

11 12 DR. VEDAL: Well, that came out 13 earlier in their ISA. I mean, that point is 14 clearly made about how we should view ozone. 15 DR. SAMET: So let's go, I think 16 we need to wind this discussion up and have a 17 quick break. Things to advance. Judy, you're 18 on for a paragraph. But things that need to 19 be brought forward to the -- 20 DR. VEDAL: The main things are 21 really, in terms of the importance of this and 22 the letter, have to do with causal categories

### 202-234-4433 Neal R. Gross & Co., Inc. Page 85 1 really. And so I think the pertinent part is 2 where we agree with what's been stated in the 3 ISA are things that should be brought forward. 4 Things that require or even suggest revisions 5 to the ISA are perhaps not as critical. 6 DR. MILLER: I'd like to ask a 7 clarifying question. Are we talking about 8 going forward in the letter as things that 9 have to be changed and improved, or are we 10 also talking about kudos of this particular 11 topic is illustrated and is very important? 12 I mean, it's not clear to me. So far, we've 13 had a mentioning of more the deficiencies, and 14 that relates to my thing about Chapter 5 15 because I think there is one kudo relative to 16 exercise that should go forward, and I've 17 written a sentence that I think would cover 18 that. So I'd like some feedback -- 19 DR. SAMET: Typically, we do 20 mention that the draft has been improved, and 21 we may point to some places that are 22 particularly good. I'm sure we will do the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 same, and then will be the "but." I mean, 2 part of our peer review job, of course, is to 3 point out what is at the level it should be, 4 and we can do that. And I think, actually, in 5 general, there has been something laudatory 6 said about almost every chapter. So, I mean, 7 so we'll -- so you have something you want to 8 say about it?

9 DR. GRAHAM: Yes. In terms of the 10 headlines for the administrator's letter, if 11 that's what you're asking, I think just some 12 sort of a shrinkage of this last bullet about 13 doing a better job of explaining the human 14 clinical, the interpretation of severity, does 15 it matter if you have a change in 16 inflammation, a clear explication of the 17 exposure response relationship down at the low 18 levels because that's going to be a center 19 point of the numerical part of the standard. 20 So that can be expressed better. 21 DR. SAMET: Okay. Anything else 22 on Chapters 6 - 7? Okay. So we're scheduled

### 202-234-4433 Neal R. Gross & Co., Inc. Page 87 1 for a break. What I'd like to do is if we 2 take a 15-minute break then by 11, at the 3 latest, finish our review of the responses but

4 then come back to these sort of broader 5 issues. I think we need some discussion, 6 maybe a little discussion with agency staff. 7 So let's break until a quarter after. 8 (Whereupon, the foregoing matter

9 went off the record at 10:02 a.m. and resumed 10 at 10:18 a.m.)

11 DR. SAMET: So we should be at 12 Chapter 8, which we're going to try to get 13 back up. 14 DR. DIEZ-ROUX: Okay. So what I 15 sent, last night, actually, I sent a very 16 small, a very short synthetic version because 17 I thought it was what you wanted in the actual 18 final letter in the front part. Aaron, did we 19 put up the slightly long -- it's just slightly 20 longer but not much. 21 Okay. So with respect to this 22 chapter, I think there are three points.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 88 1 Could we move it so that, move this -- oh, 2 Aaron's in charge? Okay. So there are three 3 main points as we get it up there. I think, 4 in general, you know, we thought the chapter 5 had been revised to incorporate the way in 6 which suggested by CASAC previously and had 7 been improved, but there were a few additional 8 suggestions for further clarifying and 9 improving the chapter. 10 One is the conceptual and 11 definition issues, and here the main point is 12 for the chapter to clearly distinguish these 13 two broad processes that can place populations 14 at, quote, increased risk. One is greater 15 ambient exposure and/or greater internal dose. 16 This includes people exposed to high levels of 17 ambient concentrations because of where they 18 live or work and also includes the point B 19 below that, people who receive greater 20 internal dose as a result of breathing pattern 21 or because they don't have air conditioning,

22 etcetera.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 89 1 The second process is greater 2 adverse health effects given a specific dose, 3 and this is the true effect modification idea 4 in epidemiology. And these factors are a 5 range of different factors which the chapter 6 covers. But, essentially, although we 7 recognize that the use of the term population 8 at risk encompasses both of these things, it's 9 not clearly articulated. Sometimes, there's 10 a little bit of ambiguity, and so being very 11 clear on that we think would be important. 12 And also reflecting this distinction in the 13 way in which the evidence is reviewed. So 14 that's the first point. And also clarifying, 15 making sure that, you know, if the terms 16 sensitive, vulnerable, or susceptible are used 17 anywhere else in the document, that they be 18 defined, that it be clear whether this is, 19 they're being used as a synonym for population 20 at risk or whether they're being used as a 21 synonym for the greater adverse effects of a 22 given dose so that we don't have inconsistent

### 202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 terminology being used throughout the

2 document. 3 Okay. That's the first point. 4 The second point has to do with the review of 5 the evidence. And here I think the main point 6 is to have, you know -- this is hard because 7 a lot of this evidence is kind of all over the 8 place but trying to be as synthetic as 9 possible in summarizing, well, what are the 10 main conclusions that we can draw regarding 11 the modifying effects of these factors for the 12 case of the effect modification? And here 13 it's important for what's said here to be 14 integrated with some of the more mechanistic 15 stuff that's discussed in Chapter 5, and also 16 there's quite a bit of review of some of these 17 effect modifiers in Chapter 6 and 7 also. And 18 so that kind of needs to be integrated and

19 make sure that the statements that are made 20 are consistent across the sections. Perhaps, 21 you know, some of this stuff that's on effect 22 modification in Chapters 6 and 7 could be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 91 1 placed in this chapter instead and just 2 referred to in the earlier chapters. That's 3 just something to think about. 4 And, finally, trying to see 5 whether we can come up with some simple 6 categorization that allows us to be very clear 7 on how much evidence we have of this effect 8 modification or of greater adverse effects in 9 certain groups. So something like, you know, 10 coming up with a simple thing, like there's 11 clear evidence, there's suggestive evidence, 12 or there doesn't appear to be much evidence at 13 this point, because I think that would be 14 important in terms of how this is carried 15 forward into the subsequent documents and to 16 what extent we focus on these specific groups 17 or not in the other two documents. 18 That's the second point. And the 19 third and final point that came up I think 20 also in the discussion is to have a place in 21 this chapter that really kind of acknowledges 22 some of the methodologic challenges in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 92 1 identifying these groups where the effects of 2 air pollution are greater. And I think this 3 is an important issue because it may help 4 explain why some of the evidence that we have 5 is still perhaps not as complete as we'd like 6 it to be, despite the fact that this is a very 7 important issue. So I think the chapter needs 8 to talk a little bit about that. In fact, 9 there's a section in the chapter that talks 10 about unexplained interindividual variability 11 and responses and that could be brought into 12 this discussion as well to say, well, there's 13 this remaining variability and responses which 14 is still unexplained. This is why it's still 15 important to think about what factors may be 16 modifying these effects. 17 That's it. Those are the three 18 points. 19 DR. SAMET: Okay, thanks.

20 Comments? Sverre? 21 DR. VEDAL: I just wanted to 22 follow up on one point, which is, you know, I

### 202-234-4433 Neal R. Gross & Co., Inc. Page 93 1 agree. I mean, in terms of reading this in 2 Chapters 6 and 7, the issue of effect 3 modification in susceptible subgroups, it's 4 very muddy and it's not often consistent and 5 it's complicated. But given the mandate that 6 we have to focus on sensitive sub-populations, 7 I kind of like your suggestion that this 8 become formalized a little bit more because it 9 is front and center here and it is confusing.

10 And whether there be more of a formal 11 mechanism in terms of grading the evidence on 12 susceptibility or sensitivity is one that, you 13 know, as you say, we should consider. It 14 would really help, and it's such a front and 15 center issue here in the ozone setting but 16 also as to how the ozone setting here now 17 translates into the policy arena. I think 18 that would be very helpful. 19 DR. SAMET: Okay. Anything else? 20 Okay. I guess you got kudos. Chapter 9. 21 DR. WEATHERS: Okay. So the first 22 part of our response is about kudos, and there

### 202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 are some specifics about new information on 2 what are genetic underpinnings, chamber 3 exposure studies, meta analyses including 4 ecosystem models. We do not suggest that 5 there are major changes that are necessary, 6 but there are some areas that need attention, 7 this is the next paragraph, including 8 references to sensing of ozone; clearer 9 statements about impact of ozone on root 10 growth; and ozone effects on native 11 vegetation; and looking at water loss by 12 plants, the effect of ozone on water loss by 13 plants. 14 We think that the chapter does a 15 nice job of integrating old and new research, 16 and we point especially to the comparison of 17 the old predictions based on exposure response 18 relationships using both the open top and the 19 chambers and the free air studies. We thought 20 it was compelling, and it was a good 21 demonstration that chamber effects may be 22 minimal and this may be something that we can

### 202-234-4433 Neal R. Gross & Co., Inc. Page 95 1 pull up to the letter as an illustration of

2 what was done well. 3 We do think this section needs 4 some technical editing. We give a few 5 examples of where that might happen, the use 6 of scale, and a couple of specific examples 7 there. And we also, as with many other 8 chapters, suggest that some definitions and 9 explanations and relationships among some of 10 these terms should be defined for this next 11 version. So that's pretty consistent among 12 chapters, I think. 13 The one thing that we don't have 14 here that I think is part of what will 15 probably show up in the letter is this need 16 for defining and explaining better the models 17 that may be used, the tools that will be used 18 for integration in the next phase. So I think 19 that in this chapter there are also examples 20 of where that will be quite helpful. If it's 21 incorporated into Chapter 2 or there's another 22 section about integration and the details of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 96 1 the modeling tools. For example, thinking 2 about extrapolation of spatial models that may 3 be used, surfaces that have to do with ozone 4 exposure, and the merging of those data with 5 site-specific empirical data. 6 So anything else to add from my 7 group? 8 DR. GRANTZ: I think that pretty 9 much sums it up. The concern about this issue 10 that she brought up at the end is I asked a 11 question yesterday about the challenges of 12 rolling back the new 126 progressive standard, 13 and the answer was that it was a spatial 14 problem of assigning locations. But I think 15 there are other problems, and I don't know if 16 it needs to go in this document or not but we 17 might suggest that we'd like to understand 18 exactly what's available to roll back, 19 essentially, since we have a paucity of data 20 across the landscape in terms of ozone impact. 21 DR. SAMET: What does your group 22 see as needing to be advanced? I mean, beyond

### 202-234-4433 Neal R. Gross & Co., Inc. Page 97 1 sort of good job and then some of the issues 2 around models, but what do you think? 3 DR. WEATHERS: I don't actually 4 think there's anything else that should be 5 advanced up to the letter or needs to be 6 advanced up to the letter. Do you concur? 7 DR. SAMET: Okay. Chapter 10? 8 DR. MILLER: Maybe not advance but 9 from your discussions yesterday I got the 10 clear impression that the paucity of monitors 11 in more rural areas really has long-term 12 consequences for the welfare standard and 13 being able to look at other things. And I 14 don't know in this chapter the same way as 15 before it was suggested about, you know, more 16 is needed or, you know, it's causal and so 17 forth, I'm wondering if something can be 18 started in this area by making comments about 19 the ability to improve the models and that is 20 dependent upon more observational data being 21 available. 22 DR. WEATHERS: Well, I think we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 could certainly say that, and I think it is 2 common to all of the areas that we're talking 3 about where there are usually paucity of data, 4 and we'll have to use what data we have in 5 order to model, to scale up or scale down. So 6 I think it's a very useful comment, and I 7 think it's broadly applicable. 8 DR. GRANTZ: I mean, it's 9 absolutely true that we don't have very many 10 rural monitors, and if you're going to say 11 anything about rural landscapes you need rural 12 monitors. But I'm not sure this is the right 13 place to put that, to be honest. 14 DR. MILLER: Well, I'm talking 15 about more if you're judging what you could do 16 or change or one is better than the other that 17 the statement is that that would be dependent 18 upon having observational data to guide that. 19 I'm talking about a subtle introduction here 20 of the fact that the welfare people have 21 gotten probably zero dollars from, oh, the 22 last 20 years and that, you know, even ozone,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 99 1 you know, it's got to be related to PM to get 2 any funding. And then we have one of the 3 republicans that wants to eliminate EPA, so

4 what the hell? 5 DR. SAMET: Okay. Maybe we should

6 move on. 7 DR. RUSSELL: Just before that, 8 one thing I think that would be good in this 9 chapter is similar to Chapters 6 and 7, just 10 a summary table of causal determinations. 11 They have a nice table of all the studies but 12 just one to causal determination, similar to 13 the prior chapters. 14 DR. SAMET: Okay, good. So, 15 Daniel, I guess we're up to Chapter 10. 16 DR. JACOB: Okay. Chapter 10, the 17 role of tropospheric ozone and climate change 18 and UV-B effects. This chapter is a little 19 bit of an odd duck because it's not really 20 related to NAAQS setting, so it's more 21 informational. But it's important, 22 particularly because in the future integration

### 202-234-4433 Neal R. Gross & Co., Inc. Page 100 1 of air quality and climate objectives will 2 probably be an increasing element of air 3 quality policy, so it plays an important 4 educational role. And it delivers okay. 5 Certainly, we're going to say that's all 6 right. I hope that in the next round we will 7 have a more beefed up analysis of climate 8 impacts associated with ozone and its 9 precursors.

10 But I have three bullets here. 11 The first one is that the discussion of 12 projections for future global emissions of 13 ozone precursors needs to be more up to date. 14 Right now, it's based on the old SRES 15 scenarios that are from the assessment report 16 2001. I understand that those scenarios have 17 been used in most of the literature that's 18 been published to date, so it's important to 19 talk about them, but it's just as important, 20 perhaps more important, to talk about the new 21 generation of scenarios that are being 22 developed as part of a fifth assessment

### 202-234-4433 Neal R. Gross & Co., Inc. Page 101 1 report, the so-called RCP scenarios, because 2 they project very different trajectories than 3 the older SRES scenarios. In particular, they 4 are far more optimistic regarding global 5 trends in the anthropogenic emissions of ozone 6 precursors. 7 Optimistic doesn't necessarily 8 mean right. For example, there's been a 9 doubling of NOx emissions in East Asia over 10 the past decade, and that's not in the RCP 11 scenarios. But, in any case, they're 12 different. And future studies, particularly 13 studies that look at the climate chemistry 14 interactions, will have to be using those RCP 15 scenarios. The SRES scenarios are history by 16 now, and so, clearly, I think the readership 17 of this document should be educated about

18 them. 19 The second bullet is the 20 discussion of radiative forcing from ozone 21 and its precursors is, in my view, inadequate 22 in that it misses a chance to talk about the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 radiative forcing associated with the 2 emissions of precursors. It talks about the 3 radiative forcing associated with ozone, but 4 you can't really directly regulate ozone. You 5 regulate emissions of precursors, and those 6 emissions of precursors affect ozone and they 7 affect other things, as well. They affect 8 aerosols, they affect OH, they have direct 9 radiative effects. And a much better analysis 10 could easily be done by just going through the 11 last IPCC report, which has some very 12 interesting analysis of the radiative forcing 13 based on emissions and, in particular, you 14 could take the message from there about the 15 fact that controlling NOx emissions is roughly 16 climate neutral, controlling VOC emissions is 17 climate beneficial, controlling methane is a 18 particularly win/win strategy, but from a 19 local air quality perspective it doesn't 20 really help that much. 21 Okay. That was my second bullet. 22 And, finally, the last bullet was about the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 103 1 discussion of UV-B effects, and Ted had some 2 comments about this yesterday also. It 3 probably needs to be there, you know. But 4 it's way too long relative to the importance 5 of the effect, and, as Ted pointed out, it 6 rambles and takes forever to get to the point. 7 The bottom line is that it's a pretty simple 8 problem figuring out the UV-B effect of 9 changing ozone concentrations in the 10 troposphere. There's a model study on this 11 that's cited in the chapter. It concludes 12 that the effect is very small. There's no 13 reason to doubt otherwise. The observational 14 studies show no significant effect. I think 15 that the chapter could be more helpful if it 16 provided an upper limit on the magnitude of 17 this effect, which would be fairly easy to 18 define. That's it. 19 DR. SAMET: Okay, thank you. Ted? 20 DR. RUSSELL: And I just might add 21 one final bullet is that, similar to prior 22 chapters, bullet statements of causal

### 202-234-4433 Neal R. Gross & Co., Inc. Page 104 1 determination should be made in the chapter 2 and that those are made in Chapters 1 and 2. 3 They're the executive summary in Chapter 2. 4 And, likewise, a table of causal determination 5 should be provided. 6 DR. SAMET: So we will just amend 7 the text for -- other comments on this? I 8 guess to the letter, I mean, we should 9 acknowledge the importance of having the 10 chapter and then possibly address the IPCC, 11 the scenarios. Should that be brought forward 12 or is that -- 13 DR. JACOB: I think that should be 14 brought forward in the letter, the new RCP 15 scenarios. 16 DR. SAMET: Okay. Other comments? 17 Okay. Then, Joe, I guess we're to all your --

18 Fred? 19 DR. MILLER: Can I get my sentence 20 for Chapter 5 --

21 DR. SAMET: Sure. 22 DR. MILLER: -- that I think ought

### 202-234-4433 Neal R. Gross & Co., Inc. Page 105 1 to go in the letter? It says, from a 2 dosimetry perspective, the second draft is 3 made clearer that activity level/exercise is 4 the major driver for effects of ambient or 5 near ambient ozone levels. 6 DR. SAMET: One more time. 7 DR. MILLER: I'll email it to you, 8 but, from a dosimetry perspective, the second 9 draft has made clearer that activity 10 level/exercise is the major driver for effects 11 of ozone at ambient or near ambient levels. 12 In other words, you don't get, it's like the 13 exercising asthmatic going by a plume where 14 the SO2 touches down. You don't see anything 15 with SO2 unless you're in that kind of 16 scenario. The exercise is such a driver of 17 considerations of this standard in terms of 18 the human clinical studies at low levels and, 19 more likely, a lot of the epidemiology.

20 DR. SAMET: I understand what 21 you're saying. I guess the question would be, 22 maybe you can get others to reflect on this,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 whether what is -- by major driver, I think 2 you're meaning a major driver of risk and that 3 you're relating back to the fact that 4 exercise/activity is a major determinant of 5 dose. And maybe if that chain were laid out, 6 I think that would help. I mean, I think the 7 sentence is perhaps too telegraphic. I don't 8 know if others could comment -- 9 DR. BRAIN: Where do you want the 10 sentence? In this Chapter 10? 11 DR. MILLER: I'm of the opinion 12 that the Administrator needs to start getting 13 educated about how important the activity 14 level/exercise is and is the factor of risk. 15 And, you know, it wasn't in the first draft. 16 It's been added in the second draft here, and 17 I think it's to the agency's plus that they 18 have done that. So it's not critical that it 19 has to be in there, but I was looking for some 20 nice things also, you know. 21 DR. SAMET: So I think if you 22 maybe extended the chain of logic a little

### 202-234-4433 Neal R. Gross & Co., Inc. Page 107 1 bit. I guess the other thing is this is kind 2 of the integrative kind of comment that should 3 sort of fit into the Chapter 2 that we might 4 like to see. Yes, yes, Howard? 5 DR. NEUFELD: Daniel, I think this 6 report you're talking about, there's not, you 7 know, projecting future tropospheric ozone 8 trends. I mean, that, to me, is amazing new 9 information that I didn't know anything about. 10 Is that published, and can we get a copy of 11 that? I mean, I'd like to see that. 12 DR. JACOB: Yes, sure. 13 MR. YEOW: Can you use your 14 microphone? Sorry. 15 DR. JACOB: Oh, okay. Google IPCC 16 RCP, and you'll find it. 17 DR. FOSTER: Fred, for equivalent 18 levels of exercise, the individual with the 19 smaller lung size would get a higher dose. 20 DR. MILLER: Absolutely, which is 21 why I relate it to the '96 publication about 22 conducting airway volume and number of that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 108 1 So I don't disagree. 2 MR. YEOW: Use your microphone. 3 DR. MILLER: That's right. And 4 it's the function of the FRC set point also, 5 because you can have individuals with smaller 6 lungs would have different FRCs, depending 7 upon their conditioning and that. So I don't 8 disagree. Are you saying it should be 9 expanded? 10 MR. YEOW: Use your microphone, 11 please. 12 DR. FOSTER: I'm just not sure 13 that it's being driven by exercise. 14 DR. MILLER: Well, even for the 15 smaller lung, it will be important because it 16 will have an even bigger effect. So I'm not - 17 - well, whatever. It will all come out in the

18 wash. 19 DR. SAMET: Okay. If you could 20 draft a sentence, we'll have an opportunity to 21 re-discuss it. So, Joe, should we go to you? 22 DR. BRAIN: Yes. I apologize for

### 202-234-4433 Neal R. Gross & Co., Inc. Page 109 1 the length of this and will do my best to 2 emulate the brevity and clarity of earlier 3 pieces, and I'll go through it rather quickly. 4 And I think we can make it shorter by both 5 condensing it and also moving some quite 6 specific comments back into individual 7 comments, so I'll do both of those things. 8 So this is the one that deals with 9 four pieces: the preamble, the preface, 10 Chapters 1 and 2. So, overall, we really like 11 this new organization. We think every one of 12 these pieces makes sense and contributes to a

13 better document. 14 And so the preamble, just a couple 15 of quick comments here. We really like it a 16 lot. In fact, this is sort of an example of 17 no good deed goes unpunished, and the 18 punishment is this is so good we think it 19 should be refined, peer reviewed, made widely 20 available. And also sort of in the same 21 category, there are a few other topics that we 22 think, you know, could be included in this

### 202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 document that are generic to multiple 2 pollutants, such as vulnerable, 3 susceptibility, that sort of discussion. So 4 that's one major point. 5 Chris suggested that it could be 6 improved by some flow diagrams, and there are 7 three examples of possible flow diagrams. And 8 the next paragraph about exposure assessment 9 I think, again, those are sort of generic 10 things that could be part of this or some 11 comparable document. 12 If you go down to preamble page 13 LV, I think this I'll either put in my own 14 comments or certainly dramatically revise. 15 You know, I meant to say that I wasn't happy 16 with singling out, you know, clinical studies 17 as the most direct evidence of a causal 18 relationship. And I guess, in particular, 19 after some conversations with Mike, 20 particularly I'm troubled by the word trivial. 21 I guess what I meant to say is human exposure 22 studies are limited by IRB considerations, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 111 1 we can't really do any subject great harm. 2 But we've learned a lot from that, so I'll 3 really change that or get rid of that 4 altogether. 5 Should we stop, John, for each 6 piece to see if there's any other 7 contributors, anybody else want to say 8 anything else about the preamble? 9 DR. SAMET: Yes. So why don't we 10 just discuss each piece at a time. And either 11 the group who helped or anyone else, comments

12 here on Joe's -- 13 DR. BRAIN: So anything else about 14 the preamble? 15 DR. WEATHERS: Just that I think 16 that the other preamble comment that I made 17 can go in the individual comments, as well. 18 DR. SAMET: Okay. Then why don't 19 we keep going to preface? 20 DR. BRAIN: All right. So then we 21 get to the preface, and, again, this, you 22 remember is really the history of ozone

### 202-234-4433 Neal R. Gross & Co., Inc. Page 112 1 regulation. And I think we all found that 2 very useful, and we just had some suggestions. 3 One, the second paragraph says, you know, 4 let's bring the history up to date and let's 5 put in events of the last three or four years. 6 I think that's one suggestion. Otherwise, we 7 think it's very good. 8 The other suggestion is that we 9 really want to make the documents that are 10 cited here available to the public as much as 11 possible. And we understand the copyright 12 constraints but all the EPA publications, it 13 would be nice if anybody could at least have 14 access to the documents that are not copyright 15 protected. 16 So I think that's a summary of the 17 preface. Important contribution, very useful 18 and essential. Anybody else want to comment 19 on the preface?

20 DR. SAMET: Helen? 21 DR. SUH: Is it possible to do 22 that last piece? Because aren't all the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 113 1 documents copyright protected and --

2 DR. SAMET: Not the federal

3 documents. 4 DR. BRAIN: Not the EPA, not

5 federal. 6 DR. SUH: But you're talking about 7 the HERO database, which is the peer reviewed 8 journals. 9 DR. BRAIN: No, if you look at 10 that chapter, more than half of the references 11 are, in fact, EPA documents. People have 12 commented several times, you know, look at the

13 -- 14 DR. SUH: So you're not talking 15 about the HERO database? You're talking about

16 the documents -- 17 DR. BRAIN: Well, they may be 18 included in the HERO database, but all I'm 19 saying we should look through and it would be 20 nice if anybody looking at this could click on 21 at least the EPA documents and get access to

22 them.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 DR. SUH: Maybe there should be 2 some clarification in this to talk about the 3 EPA documents? Because I just don't think 4 it's possible to do that with the peer 5 reviewed journals. I could be wrong.

6 DR. BRAIN: Have all documents not 7 protected by copyright available to the public 8 in complete form, such as EPA publications. 9 MR. ALLEN: And open access 10 journals. 11 DR. MILLER: There's open access

12 and also -- 13 DR. SUH: Okay, scratch my

14 comment.

15 DR. MILLER: If there's EPA 16 authors, like most of the chamber studies are 17 not copyright protected. 18 DR. BRAIN: And at least everyone 19 will get the abstract and the title, and for 20 many of us, we can then access them. 21 MR. ALLEN: And, Joe, aren't 22 current federally-funded studies required to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 115 1 go into PubMed after six months or something 2 like that? 3 DR. SAMET: You have to post a 4 copy if you're NIH-supported, a draft. 5 MR. ALLEN: NIH. Okay, NIH. 6 DR. BRAIN: So I think we're all 7 in violent agreement, and it sounds like the 8 problem isn't -- 9 DR. SAMET: How about Chapter 1? 10 DR. BRAIN: Chapter 1. So this is 11 the executive summary, and, again, I think 12 there's considerable enthusiasm for the idea 13 of an executive summary. Some disagreement, 14 should it be longer. Chris, for example, 15 thought it should be shorter. But we all 16 think it's important. I think a key concern 17 is that, you know, we need to connect these 18 provocative individual paragraphs with 19 expanded versions of the same topic, so that's 20 really in the second paragraph. And that's 21 probably easily solved by simply inserting 22 page references for tables or parts of other

### 202-234-4433 Neal R. Gross & Co., Inc. Page 116 1 chapters. So it would be nice for people who 2 want to go to the executive summary to 3 something larger should be able to do that. 4 So I think that's one suggestion that we felt 5 quite strongly about. 6 And then, again, we thought it 7 would be helpful by not only more integration, 8 I think this is a common concern that probably 9 needs to be strengthened in what we have here 10 is, we really want to see not just a summary 11 of all the pieces but link them as much as 12 possible. So I think that's a common concern 13 both for Chapter 1 and for Chapter 2. 14 And then probably, in the interest 15 of brevity, these examples of points requiring 16 classification, they probably don't belong 17 here. We could put those back in the 18 individual comments. And I don't know whether 19 any of them need to be discussed now. 20 Any other questions about Chapter

21 1? 22 DR. SAMET: Jack and then Judy.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 117 1 DR. HARKEMA: Yes. There was a 2 lot of discussion about those figures. Do you 3 have something in there about those? 4 DR. BRAIN: No, I agree. In fact,

5 the -- 6 DR. SAMET: They're complicated 7 figures. 8 DR. BRAIN: Yes. The figures 9 should be simpler or, in fact, I also noted 10 they had no figure legend. So sometimes the 11 figure legends are helpful. 12 DR. GRAHAM: Well, some of them

13 had -- 14 DR. BRAIN: I'm just thinking of 15 the blue one, you know, the atmospheric, what 16 happens to ozone. Yes, so I think we need to 17 put that in there. And, in fact, that same 18 figure appears both in 1 and 2. Thank you.

19 DR. GRAHAM: Careful because some 20 of the figures had bad legends in those early 21 chapters. 22 DR. BRAIN: I was thinking of the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 nice blue one. Yes, and then I guess we'd 2 still have some trouble with the triangle one, 3 too, and Fred was quite articulate about that 4 one. So I'll try to add some more there. 5 DR. GRAHAM: Yes. One thing that 6 we discussed in reference to this chapter is 7 should it be an executive summary or should it 8 be a lay summary? And there are inherent 9 differences. It may be that there needs to be 10 a clearer conception. I don't know that we 11 want to decide that, but for EPA to say who is 12 the audience? Because if the audience is 13 truly EPA executives then I think there's a 14 lot of extraneous material in there and the 15 main points that an executive might want to 16 know aren't brought out. However, if it's a 17 lay summary then it's basically a little 18 shrinkwrap of all the sections to follow that 19 can be cleaned up. But once you make that 20 decision of audience, I think, other things

21 flow. 22 In terms of cross-referencing, the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 1191 way it is now I think it already is cross2 referenced because it's a shrinkwrap. So, in 3 effect, each chapter has its own little 4 section, so if you want to get more 5 information it's easy enough to find that 6 chapter in the table of contents and drill 7 down. I worry about having a paragraph with 8 three sets of parentheses in it referring to 9 other page numbers or section numbers as being 10 distracting. 11 DR. BRAIN: Yes, except the 12 numbers don't match anything. You know, if 13 you're looking at individual, you know, 1.4 14 human exposure -- 15 DR. GRAHAM: No, but the topics

16 match. And so -- 17 DR. BRAIN: But then how do you -- 18 I think it should be made easier to define 19 expanded information. 20 DR. GRAHAM: Yes. Well, this also 21 gets into the issue of who's the audience 22 because if the audience really wants to know

### 202-234-4433 Neal R. Gross & Co., Inc. Page 120 1 more -- you know, you have the executive 2 audience, here's a little bit. And then you 3 have a summary chapter, like Chapter 2, here's 4 a little bit more. If you really want the 5 details, I'm sorry, you've got to read a 6 particular chapter. 7 So I think that if you're really 8 interested you could find more. I just worry 9 about cluttering up the text. There might be 10 an easy way to do it, but not to have every 11 paragraph have two cross-references to the 12 main document is all I -- 13 DR. BRAIN: No, it should read 14 smoothly and you have to do both of those. I 15 guess I'm not clear on the difference between 16 a summary for intelligent layman versus 17 executives. I'm not sure who's more 18 sophisticated. But, I mean, I guess I had 19 hoped that this would be a generic summary 20 that would be valuable to a wide range of 21 people. 22 DR. GRAHAM: Then that might

### 202-234-4433 Neal R. Gross & Co., Inc. Page 121 1 impact the title. And if it's just a general, 2 a lay summary, then I think its current 3 organization, that every chapter gets a page, 4 is not that bad. The page needs to be cleaned 5 up, but, you know. 6 DR. SAMET: So the first decision 7 is do we suggest, I mean this seems a decision 8 that really lies with EPA as to whether they 9 want to begin including a generally accessible 10 summary in the document, whether that's 11 Chapter 1 or something that's called summary 12 for the public that's placed in the document. 13 It seems like an appropriate thing to do, and 14 those kinds of summaries actually, in my mind, 15 take an awful lot of work, and I think we 16 could certainly support that. 17 I think after that then comes does 18 the document need, quote, executive summary? 19 That would be the technically-oriented one. 20 It certainly needs this integration that we 21 don't have, so, regardless of whether there's 22 also an executive summary, we certainly want

### 202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 to see this up-front integrative summary 2 process that right now Chapter 2 is a step in 3 that direction. 4 So I guess, you know, maybe it's a 5 matter of cosmetics whether there's an 6 integrative summary and an executive summary. 7 It would certainly make the document, in a 8 way, more user friendly if there were a 9 technical summary that you could go to orient 10 yourself, but I think we should give some 11 guidance on this because there are several 12 options. Fred? 13 DR. MILLER: I really feel that 14 the ISA, any summaries and that should be for 15 a technical audience. Having been there done 16 that, and the person sitting next to me, if 17 you're talking about EPA higher levels, this 18 has still way got to be condensed. I mean, 19 you have five minutes to make your point, you 20 know. To me, also, we've heard a lot of 21 comments in the past where people have new 22 post docs, and they say you want to look at

### 202-234-4433 Neal R. Gross & Co., Inc. Page 123 1 ozone, go read the criteria document, now go 2 read the ISA, and really get entrained. So I 3 think this document is really for people with 4 a technical orientation, and the summaries 5 ought to be accordingly so.

6 DR. SAMET: Other comments on 7 this? Jack? 8 DR. HARKEMA: I just want to 9 emphasize that if you're going to make those 10 changes that we suggested, the causality and 11 the short term, in that table, I think it's 12 Table 1-1, if you notched that up, the 13 cardiovascular one up there, that should make 14 note of that and not just concentrate on the 15 respiratory effects. 16 DR. SAMET: One thing I want to do 17 is make sure that we go back and look 18 carefully at what was said in our first letter 19 and changes that have been made, and I think 20 we need to revisit this because we've got to 21 lay this out in front of us when we discuss 22 the letter and just make sure that we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 124 1 understand the trail here. I just want to 2 make certain, so should we recommend that the 3 ISA have a public summary or not, or is this 4 a document I guess low down in the process 5 that may or may not be of interest? And, 6 again, perhaps this goes beyond our job 7 description a little bit in terms of setting 8 this out, but express a view. 9 DR. GRAHAM: I would suggest no 10 for there being a public summary, and that's 11 a minor suggestion. The reason is is that, as 12 we go through the process, there's more and 13 more paper created. So the big deal for the 14 public is here's a NAAQS. What we had before 15 because of blah, blah, blah, it's new, it's 16 revised, it's lower because of blah, blah, 17 blah. And so that will give the punch. It 18 will be clear and it will be crisp. There 19 will be EPA communications, professionals 20 doing press releases, so a lot of the lay 21 stuff, I mean these poor folks have enough

22 work to do.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 125 1 DR. BRAIN: I think it's being 2 offered as a summary in the context of the 3 entire ISA, which is really different than a 4 press release that -- 5 DR. GRAHAM: An executive summary 6 is fine. I'm just responding to your question

7 about -- 8 DR. SAMET: All right. So I think 9 there's rough consensus in the head-shaking. 10 So an executive summary and an integrative 11 chapter? 12 DR. BRAIN: I think we're happy 13 with that. We like Chapter 1 and Chapter 2, 14 even though they overlap to some extent. 15 DR. SAMET: Okay. So any other 16 thoughts about this up-front material in the

17 document? 18 DR. RUSSELL: Just one quick 19 comment or question, Joe. That third bullet 20 that starts "it seems that it is being claimed 21 that UV-B radiation causes no health effects," 22 I'm not sure exactly how you want them to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 126 1 respond. The conclusion from Chapter 10 is 2 that it's very, well, it's inadequate to 3 determine. 4 DR. BRAIN: I think that comes 5 from Chris, and I think we may put that in his 6 own individual comments. I think maybe that's 7 at a level of detail that's not appropriate 8 and consistent with the rest of this letter 9 responding to charge questions, and he's not 10 here to discuss that. 11 DR. SAMET: Okay. Then I think 12 what we should do is go on to some of, I 13 think, the crosscutting issues. There were a 14 few highlighted from yesterday. 15 DR. BRAIN: We haven't given 16 people an opportunity to talk about Chapter 2 17 yet, although we've covered -- 18 DR. SAMET: I think I did ask if 19 there were any more comments on this. 20 Anything else? I think we're good. 21 DR. BRAIN: Okay. 22 DR. SAMET: Okay. So just a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 127 1 couple of the issues left. So one was I think 2 Fred's comment about adaptation and 3 attenuation and coverage of that issue. That 4 might be a Chapter 2 issue. Is it given 5 enough attention? Comments about this today? 6 Judy? 7 DR. GRAHAM: I think I know in 8 some of my individual comments I said this can 9 be beefed up or that can be beefed up. So I 10 think it's an important, there's a lot of 11 discussion of it. What's not brought out is 12 that attenuation itself can be an adverse 13 effect. But I consider that to be a detailed 14 comment, as opposed to an overarching comment 15 throughout the document, whether we're talking 16 about exposure dose response, attenuation, 17 adaptation, tolerance. There's all this lack 18 of attention to consistent use of terminology, 19 and so that might be an overarching thing.

20 DR. SAMET: Fred? 21 DR. MILLER: I think I was 22 bringing it up more from the viewpoint that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 128 1 where it's introduced it's not adequately 2 enough sentences describing what is meant by 3 it and the potential interpretations, as 4 opposed to that it needs to be, you know, 5 overarching in the sense of in these 6 integrations and that. So that's where I was 7 originally thinking. However, it is, in view 8 of all the discussions about changes in FEV1, 9 it can end up being a very important thing 10 because the attenuation over a week's period 11 of pulmonary function changes being not 12 statistically significant at the end is a 13 misread as far as what's going on relative to 14 the inflammation and other processes and, 15 moreover, the kind of more structural and 16 lesion development that you can see when you 17 open animals up. 18 So in some ways, it's a caveat to 19 say, you know, okay, if you're going to 20 decide, well, these changes on FEV1, they're 21 not really that important, that's a misread of 22 interpreting what attenuation really has an

### 202-234-4433 Neal R. Gross & Co., Inc. Page 129 1 impact. Now, I leave it to you all to say 2 where should that go, and I didn't read fully 3 the health chapters so I don't know -- if you 4 feel it's adequately covered there then I'll

5 back off.

6 DR. GRAHAM: I've read all those 7 chapters. It's there, and it's covered, it's 8 covered in a lot of words. I wouldn't call it 9 adequate. I think it's a matter of precision 10 there, precision of uses of the terminology, 11 and pulling some of these things together. So 12 I'm not disagreeing with you. I'm just saying 13 it's there, but it's a specific sort of 14 comment for a particular page in like three 15 chapters, actually. 16 DR. VEDAL: Yes. I thought Fred's 17 earlier comments yesterday had to do with a, 18 you know, bringing in the concept of 19 attenuation more generally in terms of the epi 20 findings and everything else in terms of how 21 you make sense of it. I think it is 22 appropriate, though, at this point really to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 restrict it to sort of the lung function 2 setting and maybe another couple of other sort 3 of endpoint settings. I mean, it is clearly 4 an integrative issue and could play a role in 5 the integration chapter. It would be a huge 6 undertaking to try to interpret epi studies 7 from that perspective, and I don't think that

8 should be done here. 9 DR. SAMET: So I guess the 10 question would be whether, for Chapters 6 and 11 7, you just bring attention to the -- 12 DR. VEDAL: Well, 6 and 7, you 13 know, as it was brought out, I mean it is

14 covered.

15 DR. SAMET: It's covered. You're 16 happy with it?

17 DR. VEDAL: Yes. 18 DR. SAMET: Okay, all right. 19 Okay. Then why don't we shift gears in sort 20 of our remaining half hour and really discuss 21 the totality of what needs to be done, whether 22 these comments would appropriately call for us

### 202-234-4433 Neal R. Gross & Co., Inc. Page 131 1 to review a third draft of the ISA, presumably 2 possibly at the same time as the first draft 3 of the REA at the least. Let's see if we can 4 find -- we're going to put up the slide of 5 schedule, and I think this is something we may 6 want to have a dialogue with the agency staff 7 about. Yes, maybe it would be good if John 8 and Lydia came up and joined us for this 9 discussion. 10 While we're putting this up, we

11 don't need a schedule to talk about whether we 12 think we need to see the document again. 13 We've certainly talked about issues that go 14 beyond cosmetic for some of the chapters, not 15 all. I mean, some of them seem to be in 16 rather good shape and all improved, but do we 17 want to take an additional look, timing that 18 assessment I would think to go along with the 19 first draft REA, so let me throw that out for 20 discussion. Fred? 21 DR. MILLER: Well, I phrase it 22 alternatively do you feel that if they made

### 202-234-4433 Neal R. Gross & Co., Inc. Page 132 1 all the changes that we feel are needed that 2 we wouldn't need to look at it again, and I 3 don't think the answer is no. So I think the 4 answer is we need to see a third iteration. 5 Would you be willing to sign off to say go 6 make all the changes that we've suggested you 7 make and the things that need to be improving 8 and would you buy that they'll do that and 9 that we'll put our name on it? And my answer 10 is no. 11 DR. VEDAL: The first part, yes. 12 I mean, if they did everything we asked. The 13 second part is do we trust them to do it? 14 DR. MILLER: I was trying to be 15 more tactful, Sverre. 16 DR. VEDAL: Yes. I mean, the one 17 that we're clearly unhappy with, and the issue 18 is whether we need to see another version of 19 that or meet in order to see it is the 20 integration really. I mean, there are some 21 big things in other, but those don't require, 22 I mean those would require us to look at it

### 202-234-4433 Neal R. Gross & Co., Inc. Page 133 1 but probably not, I don't think necessarily --

2 well -- 3 MR. YEOW: Sverre, can you pull 4 the microphone a little closer to you? 5 DR. VEDAL: Yes. You know, the 6 most difficult part of this is going to be the 7 integrative summary and whether we need to see 8 another version of that. I can't remember 9 what we need precedent-wise in the PM 10 scenario. We went through the same exercise, 11 and it was clearly the integration that was 12 the part that we were asking for, whether we 13 went through another round on that basis. 14 For all the other things that 15 we're asking, I mean, clearly, there's some 16 big things that need to be done. But whether 17 we need to actually go through another version

18 of the ISA for that I'm not sure. 19 DR. VU: Well, I think it's the 20 decision of this group to determine whether 21 which aspects of the next version of the 22 document that you would like to see, and then

### 202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 I think that could depend on when the agency 2 published the next version and then the group 3 could, you know, selective look at certain 4 aspects, like your Chapter 2, the integration, 5 and other aspects. But, again, you all have 6 to make a decision whether you're comfortable 7 with the agency's report which is the basis 8 for the REA, so it is a decision that each 9 panel always make every time.

10 DR. SAMET: Yes. Just one 11 comment. In light of sort of the context, 12 this is a very important document in the 13 process of evaluating the ozone evidence. And 14 it seems like more peer review and looking at 15 what, presumably, will be the final product is 16 perhaps warranted and that, you know, while 17 some of the changes are cosmetic, I think it's 18 the totality that needs to be looked at and 19 how it's brought together in Chapter 2. You 20 know, we would not, presumably, need nearly so 21 extensive of a review process as we've just 22 gone through, and if we coupled this with the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 135 1 REA we could be efficient in our time in our 2 time together. So at least my thought would 3 be to be in sort of the Miller camp here and 4 think that we want a third look, particularly 5 at those critical parts. Let me just get the 6 sense -- Judy? 7 DR. GRAHAM: Yes. I would agree 8 with what Jon said and with your phrase and 9 the concepts you offered. I would add that I 10 trust them to work very, very hard and very 11 diligently and do their doggonest to make the 12 changes that we suggested. In some cases, our 13 changes are kind of crossing each other. So 14 I want to just express that we trust them. 15 The difficulty is I wouldn't trust 16 myself to do it. I think that some of these 17 things are conceptual, some of these things 18 are integrative, and so if I were, myself, if 19 I thought it was, I would still want it to be 20 peer reviewed because I would want that 21 broader thought process. 22 DR. WEATHERS: So I agree that it

### 202-234-4433 Neal R. Gross & Co., Inc. Page 136 1 should be peer reviewed. I actually don't 2 think it's a question of trust as much as it 3 is about logistics and timing. And I guess I 4 would ask EPA about whether it's useful to 5 review an integrative summary, which will 6 probably be the basis for a lot of the REA, at 7 the same time reviewing our first version of 8 the REA. So I do think we should review it. 9 The question is timing. It's not an issue of 10 trust from my perspective.

11 DR. SAMET: Joe? 12 DR. BRAIN: I agree. And I think 13 it will be relatively easy to make the 14 specific changes recommended, but we've thrown 15 out some thorny problems, like integration or 16 how do we really factor in the policy relevant 17 background and how is that explained and how 18 does that lead to decisions. So I think 19 having a look at it would be a good idea, but 20 I am concerned about logistics and delays. Do 21 we want to combine it with the REA, or do we 22 want to circulate it, give people ten days to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 137 1 look at it, and then have a teleconference to 2 talk about high level macroscopic issues? 3 DR. SAMET: Why don't we ask -- 4 DR. BRAIN: What's the best way to 5 do it? 6 DR. SAMET: So why don't we ask 7 John and Lydia to weigh in a little bit on the 8 timing issues and perhaps hear from Aaron and 9 Vanessa, as well? 10 DR. VANDENBERG: Thank you. I 11 think one of the critical issues that we could 12 get some guidance from is in regards to doing 13 a complete literature update if we do a third 14 draft. That's something that is really 15 important to us to know the scale of 16 additional studies. I know that several 17 studies were identified through the course of 18 the discussion yesterday and today, but to go 19 back and do our typical literature review of 20 the entirety of literature is a very 21 substantial effort. So I would seek some 22 guidance on that because that would affect it.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 The second point is, in terms of 2 the timing of things, again, we do work very 3 closely together and I think that's a case 4 where I would turn to Lydia to see about the 5 timing for that. I don't know what your 6 thoughts are there. 7 MS. WEGMAN: It's not when you 8 want to see the third version of the document 9 before we issue a first draft of the REA, but 10 I do think we could do that in concert with 11 the third draft so that you could have one 12 meeting to review both at the same time. I 13 think, however, there will be a delay in the 14 schedule that I showed you yesterday, and I 15 need to talk to John to get a sense of how 16 long it will take him to do the next draft of

17 the ISA. 18 My guess is that it would be a 19 two- to three-month delay before we would be 20 able to get you the first draft of the REA, 21 but I think we can do them in coordination. 22 We would probably also have a very initial

### 202-234-4433 Neal R. Gross & Co., Inc. Page 139 1 first draft of the policy assessment at the 2 same time. So I think we can make that work3 with the understanding of a two- or three4 month delay and what I showed yesterday. 5 DR. SAMET: So two comments. One, 6 I think both of you had your optimistic hats 7 on, I think, around the schedules. Second, I 8 mean, well, I think I can speak for the group 9 on this, but I don't think we were proposing 10 that the third draft ISA would reflect some 11 systematic updating of all of the studies at 12 all. I don't think anyone had that in mind. 13 I mean, the selected studies we have 14 identified but not going back and sort of 15 starting at square one on the literature 16 review -- 17 DR. VANDENBERG: If I might 18 suggest, in the individual comments, if people 19 have specific papers that they would like to 20 recommend, that might be one way of helping us 21 very much. 22 DR. SAMET: Fred and Judy?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 140 1 DR. MILLER: There's one other 2 thing that when you revise the ISA if you 3 could do, and that is when you have written 4 new material if it was like in italics. Given 5 the size of some of these chapters, you know, 6 we could focus and do the review much more 7 expeditiously if we could know what's new. 8 And so that, I think, would really help change 9 the amount of time that it takes to review it 10 and to be able to put both of them together 11 better, in terms of the meeting I mean. 12 DR. VANDENBERG: Are you 13 suggesting like a redline? 14 DR. MILLER: Yes, a redline, 15 something that, you know, this wasn't in the 16 second draft and so you can focus because, 17 like after you've gone through 30 pages of the 18 epidemiology, I mean why read every one of 19 those paragraphs again if they haven't 20 changed? 21 DR. VANDENBERG: If I might offer, 22 we've tried this before and the reorganization

### 202-234-4433 Neal R. Gross & Co., Inc. Page 141 1 makes everything look like it's new even 2 though it's not. So that's one of the 3 limitations that we've got in our technology. 4 It's something that we could try to provide to 5 some of you that would like it, but it tends 6 to be pretty messy. 7 DR. ULTMAN: That's why just maybe 8 doing some manually, just italicizing or doing 9 something manually, because I don't think the 10 organization is as important as what the 11 additions have been. 12 DR. VU: My suggestion is, John, 13 as always, when you write the charge question 14 you identify where the key changes and then 15 you specifically ask some questions, relay 16 some new information, new integrative aspects. 17 In my opinion, it's very hard to have all the 18 strike-out line and everything and on the 19 website you have clean version. It's going to 20 be a nightmare for reviewers. 21 DR. GRAHAM: On the lit search 22 issue, I would agree a full literature search

### 202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 is not needed. But the Kim studies, for 2 example, there's still a lot of data to be 3 published, so I think maybe the guidance might 4 be is if you talk to your key leading experts 5 and make sure you get the new stuff, and they 6 will know what major new data are imminent.

7 DR. SAMET: John? 8 DR. VANDENBERG: Just to clarify. 9 The comment was made by Dr. Jacob about the 10 RCP scenarios. Those are not published yet 11 that I know of. Am I missing something there? 12 Because we typically have involved, you know, 13 brought in things, and I think those are due

14 2014? 15 MR. YEOW: Can you use your 16 microphone? 17 DR. JACOB: I'm sorry. There's 18 documents that have been available for a long 19 time. And it's not peer-reviewed journal 20 literature, but those are IPCC publications. 21 DR. VANDENBERG: Okay. We just 22 want to make sure we're referring to --

### 202-234-4433 Neal R. Gross & Co., Inc. Page 143 1 DR. JACOB: I was very conscious 2 of this, but I think it's up to the standard 3 of the material that you would include in the

4 ISA. 5 DR. VANDENBERG: Okay, thank you. 6 DR. SAMET: Okay. So I think what 7 we're heading for then is a focused review of 8 the third draft ISA coincidentally with the 9 first draft REA, that this will probably not 10 be May but more likely July? 11 MS. WEGMAN: I think July is a 12 safe guess at this point. 13 DR. SAMET: Okay. So probably 14 July, a lovely hot day here. Okay.

15 DR. GRANTZ: Does that mean that 16 in July we would review the third draft ISA 17 and receive public comments on the third draft 18 ISA? Will there be a public comment -- 19 DR. SAMET: There will be a public 20 comment period.

21 DR. GRANTZ: And then we'll move 22 immediately into the REA? That feels

### 202-234-4433 Neal R. Gross & Co., Inc. Page 144 1 uncomfortable to me, frankly. 2 DR. VU: The typical public 3 process is that since the CASAC is going to be 4 reviewing two documents there will be a public 5 session to review the third draft ISA and then 6 there will be a public session to comment on 7 the first draft REA. That has been historical 8 process we do. 9 MS. WEGMAN: And Karen is throwing 10 darts at me with her eyes telling me that July 11 is impossible, so I think it will probably be 12 more likely August when we could -- even a 13 hotter month, Jon. 14 DR. VU: I would say, you know, at 15 this point in time, Holly will communicate to 16 the panel in terms of the availability of the 17 agency's publication of these documents, and 18 then she will follow up with you with regard 19 to the follow up and possibly maybe, you know, 20 some communication to you all.

21 DR. SAMET: Fred? 22 DR. MILLER: I think the agency

### 202-234-4433 Neal R. Gross & Co., Inc. Page 145 1 will get far more criticism if, even though 2 it's requiring lengthening the time line, that 3 you didn't have this third iteration. And 4 I'll just clarify I wasn't talking about 5 trust. I think this is so integrated and so 6 complex that we really want to see it. My 7 colleagues, it's not a question, but I'll 8 repeat what I said a long time ago that I 9 don't really care if the Administrator goes to 10 jail because they've not met a deadline. We 11 need to get it right, and the actual 12 implementation of all of this, you know, 13 that's what comes important is do it right. 14 DR. SAMET: So what do you really 15 think? 16 (Laughter.) 17 DR. MILLER: I'm trying to ensure 18 that I won't be invited to be on any other 19 panels. 20 (Laughter.) 21 DR. SAMET: John or Lydia, do you 22 have any more comments or responses here?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 MS. WEGMAN: I have nothing more 2 about the schedule, but I did want to take 3 about five minutes, if folks have the time, 4 just to talk a little bit more about the REA 5 and this question of total risk and how we 6 plan to do the -- 7 DR. SAMET: Sure, go ahead. 8 MS. WEGMAN: -- analysis in the 9 REA and how it will fold into the policy 10 assessment. I'm going to let Bryan speak in 11 a moment to how we're going to look at the 12 risk in the REA, but I do want to make it 13 clear that we fully intend in the policy 14 assessment to take into account background and 15 all of the spatial and temporal variability 16 issues that you all have discussed during the 17 past two days. We're not going to go off and 18 propose alternatives to a standard that do not 19 recognize the existence of background, and we 20 fully intend to take into account what is in 21 the ISA and the comments that we've heard in 22 thinking about how to develop options in light

### 202-234-4433 Neal R. Gross & Co., Inc. Page 147 1 of background and how it varies throughout the 2 country. So I just want to reassure everybody 3 on that point since there seemed to be a lot

4 of concern on that. 5 And when we talked yesterday about 6 implementation, we are not saying that we are 7 going to be ignoring background in the 8 standard-setting process. We are definitely 9 going to consider it. Implementation is 10 another area where background can come into 11 account, but it will be fully discussed and 12 considered in the policy assessment document. 13 So I wanted to clarify that, and 14 if anybody has any questions. Yes, Sverre? 15 DR. VEDAL: I don't have any 16 questions. I mean, I don't know if I'm the 17 lone person here, but I thought your initial 18 statement on this was right. I mean, from the 19 ISA stage, ozone is ozone. From the epi 20 studies, ozone is ozone. From the 21 experimental studies, ozone is ozone. And 22 that's the first stage. What we do

### 202-234-4433 Neal R. Gross & Co., Inc. Page 148 1 subsequently is a secondary issue and not a 2 less important issue but a secondary issue. 3 The primary issue here is health effects of 4 ozone, and an ozone molecule is an ozone

5 molecule. 6 MS. WEGMAN: And we don't disagree 7 with that, and we still plan to lay that out 8 in the REA. I just wanted to be clear that by 9 the time we get to the policy assessment we 10 are going to think about background in the 11 context of the standard setting. Karen, did 12 you want to -- 13 DR. MARTIN: I just would think 14 about it in terms of, while the considerations 15 we lay out as a basis for standards are to be 16 based in our scientific understanding of the 17 effect of ozone on public health and public 18 welfare, clearly important considerations for 19 people to think about are the context and the 20 perspective that those alternative standards, 21 the current standards and alternative 22 standards have in conjunction with our

### 202-234-4433 Neal R. Gross & Co., Inc. Page 149 1 understanding of background concentrations, 2 anthropogenic concentrations, where ozone 3 comes from. It's not a health science issue, 4 but it provides some context and background, 5 and that's the way in which we typically have 6 discussed it in policy assessments in the past

7 and now we have tools that allow for a much 8 more nuanced understanding of spatial and 9 temporal patterns of backgrounds, how they 10 differentially affect different places in the 11 country. And I think that's the kind of 12 perspective we can bring in in a more nuanced 13 way into this policy assessment. 14 DR. SAMET: Okay. We're going to 15 hear from Bryan. 16 DR. HUBBELL: I just wanted to 17 clarify two points. One is that, in addition 18 to total ozone risk, which is, again, 19 something we haven't estimated in the past, I 20 want to make it clear that we are still 21 planning on providing the distribution of risk 22 over the concentration so that you'll be able

### 202-234-4433 Neal R. Gross & Co., Inc. Page 150 1 to understand the incidence of risk at 2 different levels of ozone. So that would 3 allow that to be brought forward into the 4 policy assessment where considerations of the 5 amount of exposures with different background 6 concentrations of the urban areas that we're 7 modeling, what those contributions may 8 provide. 9 But, again, the focus of the risk 10 analysis will be on total risk contribution 11 and then the distribution of risk over the 12 concentrations. When we look at meeting the 13 current standards and potential alternative 14 standards, that's where considerations of 15 background become important because it allows 16 us to understand how best to simulate how we 17 might attain those standards, understanding 18 that there are different contributions from 19 the U.S. and from international sources. So 20 I want to make sure that you understand we 21 weren't taking background out of the picture, 22 it's just being moved into our consideration

### 202-234-4433 Neal R. Gross & Co., Inc. Page 151 1 of roll back rather than in our consideration 2 of total risk. 3 DR. SAMET: Thank you for the 4 preview. Okay. Any other comments? I think 5 we are in agreement about what will happen 6 next. I think there's consensus that a third 7 review is appropriate and that we'll join that 8 with a first review of the draft REA. So let 9 me say while we're here together is there any 10 last comments from the panel? 11 DR. VU: No, and you should talk 12 about the next step to schedule another public 13 teleconference call. But since I have the 14 mic, I want to thank you, Jon, and members of 15 this panel for an excellent conversation and 16 review of the second draft ISA and thank the 17 agency folks, as well as very helpful public

18 comments. And I want to thank members of the 19 public their indulgence and the new 20 innovative, the second round of public 21 comments that we instituted since October, and 22 it's a work in progress and we'll do a better

### 202-234-4433 Neal R. Gross & Co., Inc. Page 152 1 job to implement that second round of public 2 comments. Thank you. 3 DR. SAMET: Let me add my thanks 4 for the panel's hard work and comments. And, 5 again, thanks to the public who commented, the 6 EPA staff of course, Aaron for his efforts

7 here. And Fred? 8 DR. MILLER: I just want to suggest 9 that, and I suppose this will be done, but as 10 soon as they have some months that they think 11 it could happen then or later that we get a 12 poll in terms of availability among panel 13 members because calendars fill up far out. 14 DR. SAMET: Okay, yes, understood. 15 So let's talk about just sort of the end game 16 on this review. 17 MR. YEOW: So I'll follow up with 18 you regarding our follow-up schedule, but, 19 basically, what it will entail is we'll ask 20 for any revisions to your individual comments 21 to be sent back to us. Then we will ask the 22 lead authors to refine or expand, based on the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 153 1 discussions today, on the consensus responses

2 and send that both to me and Dr. Samet. Then 3 we'll work on the letter to the Administrator, 4 pulling out the key points that you had 5 identified. 6 Then what we'll do is we will 7 schedule a teleconference, and we'll poll you 8 for your availability, for us to discuss that 9 draft letter. And, again, that draft letter 10 is three parts: the letter to the 11 Administrator, the consensus response to the 12 charge questions, as well as your individual

13 comments. 14 DR. SAMET: Okay. Good. And 15 Sverre, actually, could you take over on the 16 epi section since Michelle is not here? We'd 17 appreciate that. Thank you. Okay. Thanks, 18 and let's all go home. 19 MR. YEOW: Thank you. We can be 20 adjourned. I'd like to thank you all again. 21 (Whereupon, the foregoing matter 22 was concluded at 11:25 a.m.)

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54:4 87:12 8-hour73:19 8:30 1:13 8:33 4:2 88 63:8 9 9 93:20 95 61:16 96 107:21NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com C E R T I F I C A T E

This is to certify that the foregoing transcript

In the matter of:

Before:

Date:

Place:

was duly recorded and accurately transcribed under my direction; further, that said transcript is a true and accurate record of the proceedings.

----------------------- Court Reporter 176

Ozone Review Panel

US EPA

01-10-12

Durham, NC