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

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## U.S. ENVIRONMENTAL PROTECTION AGENCY

+ + + + + CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

OZONE REVIEW PANEL

+ + + + +

PUBLIC MEETING

+ + + + + WEDNESDAY, SEPTEMBER 12, 2012

+ + + + + The meeting convened in State Ballroom A and B of the Marriott City Center, 500 Fayetteville Street, Raleigh, 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 WEATHERS202-234-4433 Neal R. Gross & Co., Inc. Page 2

PANEL MEMBERS PRESENT: ED AVOL MICHELLE BELL JOSEPH D. BRAIN DAVID CHOCK WILLIAM MICHAEL FOSTER DAVID GRANTZ JACK HARKEMA DANIEL JACOB STEVEN KLEEBERGER FREDERICK J. MILLER HOWARD NEUFELD JAMES ULTMAN SVERRE VEDAL PETER WOODBURY

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF PRESENT: ANGELA NUGENT, Designated Federal Officer VANESSA VU, Director, SAB Staff Office SUSAN ANENBERG, OAQPS CHRISTINE DAVIS, OAQPS JEFF HERRICK, NCEA BRYAN HUBBELL, OAQPS AMY LAMSON, OAQPS JOHN LANGSTAFF, OAQPS

KRIS NOVAK, NCEA ZACHARY PEKAR, OAQPS HEATHER SIMON, OAQPS TRAVIS SMITH, OAQPS LYDIA WEGMAN, OAQPS BEN WELLS, OAQPS KAREN WESSON, OAQPS YUQUAN ZHANG, RTI International, Contractor Page 3

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

Chapter 6 - Controlled Human Exposure by Dr. Jack Harkema . . . . . . . . . . 22 by Dr. James Ultman . . . . . . . . . . 26 by Dr. Steven Kleeberger. . . . . . . . 37 by Dr. Michael Foster . . . . . . . . . 40 Chapter 7 - Epidemiology by Dr. Sverre Vedal . . . . . . . . . . 44 by Dr. Diez-Roux. . . . . . . . . . . . 58 by Dr. Fred Miller. . . . . . . . . . . 62 Chapter 8 - National Scale Risk Assessment by Dr. Christopher Frey . . . . . . . . 82 by Dr. Ted Russell. . . . . . . . . . . 91 by Mr. Ed Avol. . . . . . . . . . . . . 94

Chapter 9 - Synthesis by Dr. Michelle Bell. . . . . . . . . .103 by Dr. Christopher Frey . . . . . . . .107 by Dr. Ted Russell. . . . . . . . . . .113

Review of Proposed Changes by Dr. Hubbell. . . . . . . . . . . . .119

Discussion of Health Risk and Exposure Assessment by Chair Samet, Moderator . . . . . . .122 by Dr. Travis Smith . . . . . . . . . .206 Ch. 1 - 3, Introduction, Conceptual Model and Scope

by Dr. Kathleen Weathers. . . . . . . .227 by Dr. Peter Woodbury . . . . . . . . .233 Ch. 4 - Air Quality by Dr. Daniel Jacob . . . . . . . . . .253 by Dr. Ted Russell. . . . . . . . . . .268 by Mr. George Allen . . . . . . . . . .269 Page 4 Ch. 5 - Ecological Effects by Dr. Kathleen Weathers. . . . . . . .277 by Dr. Howard Neufeld . . . . . . . . .280 by Dr. David Grantz . . . . . . . . . .293 by Dr. Peter Woodbury . . . . . . . . .305

CHAPTER 6 - ECOSYSTEM SERVICES by Dr. David Grantz . . . . . . . . . .306 by Dr. Peter Woodbury . . . . . . . . .308 by Dr. Kathleen Weathers. . . . . . . .309 by Dr. Howard Neufeld . . . . . . . . .322

CHAPTER 7 - SYNTHESIS by Dr. Howard Neufeld . . . . . . . . .330 by Dr. Kathleen Weathers. . . . . . . .341

CLARIFYING COMMENTS FROM THE PUBLIC . . . . .349

ADJOURN . . . . . . . . . . . . . . . . . . .393

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1 P-R-O-C-E-E-D-I-N-G-S 2 (8:33 a.m.) 3 DR. NUGENT: Good morning, 4 everyone. It's time to resume our public 5 meeting. The second day of the CASAC ozone 6 review panel meeting. 7 And for the record, again, I'm 8 Angela Nugent, the designated federal officer 9 for the panel today. I want to draw the 10 attention of the public to our additional 11 public comment opportunity this afternoon at 12 5:00 p.m. 13 And this is a public comment 14 period where members of the public need not 15 have contact to the SAB staff office way in 16 advance to provide comment. But I asked them 17 to let me know by 3:00 p.m. today whether they 18 wish to provide some additional comments. 19 And I should stress the importance 20 of additional. We want to hear any new 21 information that they want to bring to the 22 attention of the panel, and especially202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 clarifying information that may be useful to 2 the panel in its deliberations. 3 So if individuals can send me an 4 email, or come up to me during the meeting or 5 during the break, I'll put their name on the 6 list to provide comments to be no more than 7 three minutes in length. So that's it in

8 terms of formal comments. Dr. Samet? 9 CHAIR SAMET: Welcome back to Day 10 2 of CASAC Survivor, the Raleigh version. I 11 understand that we're voting several people 12 off the show today, including, you too? 13 Wow, and Daniel. Well, you can be 14 replaced. So what we want to do is go back.

15 Remember we had heard from the commenters on 16 Chapter 5, populations at risk. That was from 17 Helen, Michelle, and Ana. 18 And maybe if we could just recap 19 your comments really quickly as a reminder and 20 then open up for general discussion. So,

21 Helen? 22 DR. SUH: Just quickly, there were Page 7 1 three sets of charge questions. The first 2 charge question asked about the methods. And 3 I think, do you want me to just speak for 4 myself or for --

5 CHAIR SAMET: Yes. 6 DR. SUH: Okay. So I guess the 7 methods were good but complicated. And so it 8 would be helpful to have a figure to 9 illustrate how the APEX model works. 10 Also it would be good to have some 11 more precision clarification about certain 12 aspects of the methods, including about the 13 uncertainty analyses and the methods that will 14 be used, even if it's a qualitative 15 uncertainty analysis. 16 Also information about model 17 performance, more specific, because I 18 understand the model's been improved. But 19 what is the overall effect and, I guess, how 20 the model could be validated, at least in 21 part, so the performance could be quantified 22 in some aspects. Page 8 1 Also in terms of the multiple 2 repeated exposure analysis, how that's going 3 to be done and with what database, given the 4 deficiencies or the limitations of the 5 activity databases that exist currently. 6 So those are some of the main 7 areas. Also in terms of the second charge 8 question, which had to do with the 9 presentation of the results in the 10 interpretation, there was also some 11 clarification that would be very helpful. 12 One is in the overview of the 13 presentation of the figures and tables. It 14 would be helpful. It was very hard for me to 15 figure out which references went to what, so 16 perhaps maybe even a reference to the figure

17 numbers themselves. 18 And also beyond just the overview 19 of what the figures and tables were, it would 20 be good to have a discussion, or a summary, of 21 the overall main findings from those figures. 22 So what are the main points that Page 9 1 you would like the reader to take home from 2 those figures and tables. That would be good 3 to have a text discussion of that. 4 And I guess also, for Section 5 5.6.1, it was unclear how that was going to be 6 incorporated into the subsequent analyses. 7 Even if it was going to be helpful in the 8 qualitative part of the uncertainty analysis, 9 it would be good to have some discussion to 10 tie that part in. 11 And I guess the other point with 12 the methods is there needs to be more 13 discussion about the databases and their age, 14 and their relevance and appropriateness. 15 I think it's just an inherent 16 limitation. But perhaps there's something 17 that could be done to discuss their impacts, 18 or maybe if there's some other more recent

19 data sets that can be used to even see the 20 trends and how the activity patterns might be 21 changing across the years. That would be 22 helpful.202-234-4433 Neal R. Gross & Co., Inc. Page 10

1 And there were some more current 2 databases. And maybe some comparisons can be 3 made in those ways. 4 There's also, I guess, very few 5 related to children. And the question is, is 6 that enough, or is that going to be sufficient 7 to characterize for the 16 cities. 8 Then regarding the uncertainties 9 and variability, it was unclear what was going 10 to be done. What was set out sounded good. 11 The question is, it was unclear what was going

12 to be done. 13 And even if it is a qualitative 14 analysis, I think it would be good to have 15 some more description about what that 16 qualitative analysis is supposed to achieve. 17 What are the goals of it? And then also what 18 really is going to be done, how is it going to 19 be conducted, would be helpful. 20 Also, I guess, for me I think the 21 averting analysis, the averting behavior 22 analysis, should be incorporated in the Page 11

1 uncertainty analysis somehow. 2 I think it's a nice piece, what's 3 in there now. But it just needs to be tied in 4 better to what's going to happen going

5 forward. 6 CHAIR SAMET: Okay. Michelle? 7 DR. BELL: So I'll be brief. And 8 so my thoughts were very much in line with

9 Helen's. 10 I thought that a flow chart, the 11 process would be useful. Just as was already 12 mentioned, there needs to be more discussion 13 of the uncertainties. 14 And I had recommended considering

15 a table or some other format where EPA 16 outlines the uncertainties that they're 17 incorporating in a quantitative way, ones 18 they're incorporating in a qualitative way, 19 where they discuss what are the anticipated 20 directions. 21 And then maybe list some 22 uncertainties, where we don't have an idea Page 12 1 what the anticipated direction might be on the 2 results, but remember the benefits and costs 3 of the Clean Air Act had that for health 4 outcomes, ones we can quantify and ones we 5 suspect. 6 So I thought that would be useful 7 here because I think a lot of thought has gone 8 into the uncertainty that could be used to

9 make that table. 10 And it was kind of hard to

11 evaluate some of the methods for the 12 sensitivity analysis because they weren't 13 specified. But, as I mentioned yesterday, I 14 suspect EPA has really good ideas for this. 15 That it just is hard to evaluate without the 16 details. 17 I suggested consolidating some of 18 the figures and to be a little more careful 19 about labeling them. So the example I've 20 given was using 6-8 for 2006 to 2008. And 21 these are all things that can be fixed. It'll 22 just make them easier to read, especially as Page 13 1 we know more figures are coming. 2 In general, I thought that this 3 chapter could be better referenced. There 4 were a few places where some rationale was 5 given, but it would be helpful for readers to 6 have references. And in my written comments 7 I give a few specific examples. 8 And my last point is that there's 9 a lot of language that I found kind of vague, 10 where again I assume that EPA has really 11 specific ideas about what they mean. And I 12 think it would be useful to put them in. 13 And again, in the written comments 14 I give some specific examples, just to give 15 you a better idea of how I'm thinking about

16 that.

17 CHAIR SAMET: Ana? 18 DR. DIEZ-ROUX: Yes. So I raised 19 a point about the representativeness of the 20 time-activity data and the implications of 21 that for the exposure estimates. 22 Then, in terms of the presentation202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 of the results, to think about what sub-groups 2 really need to be shown. And I guess that's 3 linked to the sub-groups in which the 4 attributable mortality is going to be 5 estimated, and so forth, but thinking more

6 about that. 7 A second point was what the 8 metrics should be for the exposure estimates 9 that are shown. And I suggested thinking 10 about showing continuous distributions, in 11 addition to these dichotomous measures of yes 12 or no exposed to values above a certain level, 13 looking at the distribution across the whole 14 continuum, and also variability, describing 15 some of the variability in that distribution. 16 And in terms of the sensitivity 17 analysis, if there was any way to be able to 18 look a little bit at the implications of the 19 assumptions regarding time-activity data and 20 also the backgrounds. 21 CHAIR SAMET: Okay. Thank you. 22 So let me open this up for further comments Page 15 1 from the panel. Fred?

2 DR. MILLER: I have a comment. 3 But Chris had his hand up first. 4 CHAIR SAMET: Oh, go ahead, Fred. 5 DR. FREY: No, you go. 6 DR. MILLER: I'd like to bring up, 7 again, the concern relative to the CHAD 8 database and the fact that most of the data in 9 it are more than a couple of decades old. 10 And my grandson, that's 3 1/2, has 11 got a different activity pattern than I know 12 a 3 1/2 year old did 25 years ago. And I have 13 a concern about the representative of this. 14 And so I'd like to offer up, there 15 is a 2006 paper by, I don't know if you're 16 aware, from the people in Montreal, where they 17 followed 2,200 people, ages 1 month to 96 18 years, more than 20,000 exposure days. 19 And they used doubly label water. 20 And they have the percentiles of the 21 distribution for total daily and minute 22 ventilation from the 5th to the 99th, in all Page 16 1 these different age groups. 2 And I was wondering -- and I 3 talked briefly with Helen about this and I'm 4 going to send her the paper -- if you could 5 maybe use that as a cross-check from your 6 sampling, where you come up with where you 7 feel that your individuals are compared to 8 where the individual, based upon the daily 9 minute ventilation that you come up with, 10 would be, to see if there's been a shift in

11 that. 12 And it goes to some of the things 13 that have been raised about sensitivity and 14 other kinds of analyses. And they actually 15 made measurements and compared it with 16 different other methods in that. 17 So it seems like it might be 18 something that you could find useful. It's 19 not my area, but for some reason I have the 20 paper. 21 CHAIR SAMET: So, Fred, following 22 yesterday, you should put that into your Page 17 1 individual comments, what the reference is, so 2 that it's there, and into your comments for 3 this charge question. 4 DR. MILLER: Okay. I can't just 5 send it to Helen and let her do it? 6 CHAIR SAMET: Yes, that would be 7 fine. It needs to go into the database. 8 DR. MILLER: Yes. And it clearly 9 needs to be added to the ISA if it's not in 10 there, as they brought up about the McDonnell 11 and other things. So I'll make sure. One way 12 or the other it'll get in there. 13 CHAIR SAMET: And actually, in 14 follow-up, there's certainly a lot of very 15 comparatively elegant time-activity work going 16 on now using more sophisticated monitors. 17 And I wouldn't know that it's 18 going on. I don't know what is in the 19 literature, perhaps other do. But as a 20 general question, have you searched for 21 updates on time-activity patterns? 22 MR. LANGSTAFF: Yes, we've done202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 that. But we'll look at this paper and 2 compare the ventilation rate distributions to 3 what APEX is estimating. 4 DR. HUBBELL: And one other point. 5 And we're providing this list of potential 6 changes that you'll have later on today. But 7 one of the things that we've identified is 8 this American Time Use Survey data, which may 9 have some information that helps us look at 10 some more recent activity patterns. 11 But again, we're still in the 12 process of bringing that data in and 13 evaluating it. It's a fairly complex data 14 set, so we're working with that. 15 DR. NUGENT: And MESA Air has 16 collected some time-activity data, right? I'm 17 not sure how detailed it is and how relevant 18 it would be to, well, but not just looking at 19 kids There're no kids. It's only adults. 20 But that could be something to explore too.

21 I don't know. 22 CHAIR SAMET: Okay, Chris? Page 19

1 DR. FREY: Yes. Maybe it's more 2 of a policy question, but I think it touches 3 on the CHAD data, the averting behavior. So 4 I looked at Chapter 5 because I had to review 5 the summary, Chapters 8, 9, and that builds on

6 the rest of the document. 7 And I think one thing, I didn't 8 get a clear picture from the current REA as 9 what is EPA's position on averting behavior. 10 Because it seems like you could certainly look 11 at that in a descriptive way, as far as 12 interpreting epidemiological studies where 13 averting behavior is just an artifact of the 14 activity pattern that was observed. 15 But I think when you're looking 16 prospectively at risk assessments to inform 17 setting of the standard, it raises the 18 question should we be, in a sense, taking 19 credit for people avoiding going outdoors 20 because the air quality is bad? 21 Or should people have, 22 essentially, a right to go outside, even if Page 20 1 they're in a sensitive group. And so it's 2 less clear to me that averting behavior should 3 be done in a prospective risk assessment aimed 4 at setting a standard. 5 And then also we get into some of 6 these issues of the time-activity pattern. 7 While maybe some kids spend all day in front 8 of video games, others spend all day9 skateboarding. And so we could look at sub10 groups where there are kids who spend a lot of 11 time outdoors, even in modern-day culture. 12 So I don't know to what extent it 13 makes sense in the REA. But it seems like, 14 well, the REA has to either implicitly or 15 explicitly take this on and make a statement. 16 And is it that averting behavior 17 is assumed to be something from a policy 18 perspective that's going to be a compensating 19 mechanism for otherwise unacceptable air 20 quality? But that's really, I think, a policy 21 choice, not necessarily a science choice. 22 CHAIR SAMET: Okay. Page 21

1 DR. NUGENT: If I can just add, I 2 had a similar concern. I think one of the 3 places where this can be addressed is in this 4 framework chapter, that we talked about 5 yesterday, that there not being a very clear

6 framework. 7 That would be a place where one 8 could discuss how averting behavior is or is 9 not going to be considered, for example. 10 CHAIR SAMET: Okay, Ed. 11 MR. AVOL: Just to reiterate one 12 aspect of this and sharpen the focus, I think 13 it's useful and important to review the14 overall CHAD database and look at other time15 activity information across the spectrum.

16 But because there's been so much 17 information that has become available in early 18 life exposures, and the importance of early 19 life exposures in characterizing respiratory 20 and cardiovascular and just a whole range of

21 health outcomes later on. 22 The fact that we really don't have202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 anything in the zero to five category, in a 2 risk document, I think is an important gap

3 that somehow needs to be addressed. 4 It needs to be described or 5 discussed. It's a critical research need. 6 But somehow, I think because of all that's 7 been done from asthma to so many other 8 diseases, we need to somehow close that gap. 9 DR. BRAIN: And you could even 10 mention gestational exposures of moms as well. 11 CHAIR SAMET: Okay. Other 12 comments on Chapter 5? Well, Chapter 6? 13 Okay, so this is controlled human exposure,

14 Jack? 15 DR. HARKEMA: So I have just some 16 quick comments. And I'm not going to go in a 17 lot of detail. But I think Question 1 methods 18 part, I think we've touched on -- 19 CHAIR SAMET: Jack, you might pull 20 the mic over just a little bit. 21 DR. HARKEMA: Okay, I'm sorry. 22 This has been brought up before, but the Page 23

1 methods of McDonnell and Schelegle, the new 2 papers, first of all those have to be

3 documented. 4 You were right yesterday to point 5 that out, that should be documented in the 6 ISA. And it has to be incorporated somewhere 7 in there and then referred back to. 8 But at first I thought that you 9 should compare all three methods. But I think 10 that's labor intensive and it would just be 11 way too labor intensive to do all three of

12 those. 13 But I think that it would be, from 14 what I read, and this isn't my area but it 15 seems like those papers, that would be the 16 crucial threshold model to use in this 17 approach. 18 Now, I have actually almost the 19 same comment that was in Chapter 5. I thought 20 there should be some type of diagram or flow 21 chart on the methodology that will enhance the

22 text as well. Page 24 1 And also where parts of the data 2 will be input into the different aspects, when 3 you're going from controlled human exposures 4 and then all the way through the population 5 base, just give it a flow. Set the stage for 6 it. 7 And then also there's some mention 8 of background in here, but more specifics of 9 where that would be inputted into the model. 10 And so that may be clear to you, but for 11 someone that's outside of the area if that can 12 be really stated how that would be put in 13 place. 14 The other thing, I think there 15 needs to be a stronger rationale. I agree 16 that using the FEV1 is the most appropriate in 17 those data. But I think there needs to be a 18 little bit stronger rationale and clearer 19 rationale in this document of why you're using 20 that compared to the other responses. And I 21 think that can be handled very easily.

22 And then there's a lot of Page 25

1 references back to the older documents, but

2 not as much back to the current ISA. So I 3 would put a lot more.

4 Go back to the ISA. And that's 5 where the chapters that deal with controlled 6 exposures there need to be very clear. And 7 then you can reference and build the case 8 while you're using the risk analysis there. 9 The other charge questions, I 10 think the biggest thing is to look at these 11 new papers. But also in terms of the 12 discussion on certainty and variability, I 13 guess I have similar to Chapter 5. 14 If you could build a table or a 15 summary somewhere in the text, where you 16 really clearly state the strength and 17 limitations of each of the models and where 18 the uncertainty and variability is found, so 19 it's very concise rather than a long 20 discussion in the text. So that's about it. 21 CHAIR SAMET: Okay, thanks. Jim? 22 DR. ULTMAN: Sorry.202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 CHAIR SAMET: That's all right.

2 Go ahead. 3 DR. ULTMAN: I didn't realize I 4 was next. I have re-written the first part of 5 my remarks. And I will update them so you'll

6 be able to read them. 7 But I've been giving quite a bit 8 of thought to the use of the FEV1 filtered air 9 correction. It's not a trivial matter. And 10 I know you realize that. 11 So my first comment is, I don't 12 know if you realize it, or maybe I'm not 13 right, but in this REA I don't see any clear 14 definition of how the percent delta FEV1 was

15 calculated. 16 And there're many ways you can 17 calculate that. And it's really not said. 18 But if I go back to the ISA, there's a very 19 strong leaning toward correcting FEV1 20 decrement by filtered air to come up with a 21 percent delta FEV1. 22 In fact, there's about a page and Page 27 1 half devoted to explaining why that's a good 2 idea to do that. There's a problem though. 3 And what I'm referring to is the fact that one 4 of the ways of calculating the delta FEV1 is 5 to take the difference between the ozone 6 exposure and the filtered air exposure

7 decrement. 8 So each one is a decrement. You 9 have exposure to ozone. You have the 10 decrement in FEV1. You have an exposure to 11 filtered air. You have a decrement of FEV1. 12 You take the difference between 13 those and you get a corrected decrement of 14 FEV1 exposed to ozone versus clean air. And 15 that's normalized so you get a percent. 16 But basically you're trying to 17 correct for, by using filtered air. Now what 18 are you correcting for? That's the question. 19 And I've found in the literature, 20 and also in the REA, that the argument seems 21 to be that if somebody, for example, has 22 hyperreactive airways, and they're exposed to Page 28 1 clean air and they're exercising, they're 2 going to get a decrement in their FEV1. 3 So if they then are exposed to 4 ozone, there's two components that's coming 5 into it. It's the exposure to ozone itself, 6 plus an intrinsic effect of exercise to cause 7 airway closure, or airway narrowing. 8 So the idea is to try to get that 9 effect out. And that's considered important. 10 So as an aside, I don't know why that effect 11 is any different than age or anything else. 12 It's an effect modifier and I 13 don't know why it has to be gotten out. Well, 14 it has to be gotten out that way because you 15 don't know if it's there or not. Like age, 16 you can tell what a person's age is, but you 17 can't tell if they're getting hyperreactive or 18 not, if that's the cause. 19 Now the problem comes in that 20 there can also be a day-to-day variation in 21 the measurement system. So when you take that 22 difference, between the clean air and the Page 29 1 filtered air, you're introducing an additional 2 error, due to the measurement system, into it. 3 So that's the down side of doing 4 it that way. And this all seems like it's 5 very academic until we get down to very low 6 ozone exposures. 7 And what happens at very low ozone 8 exposures is that filtered air contribution, 9 although it's a relatively small contribution 10 at high exposures, it becomes a large 11 contribution. 12 A much larger contribution is when 13 you're at low exposures and your decrements 14 are small. Does that make sense? So you're 15 taking the difference of two small numbers. 16 And you can really amplify. If 17 there's a small error in the measurement from 18 day-to-day, you can really amplify that error.

19 And that's what concerns me. 20 Because then we're looking at all 21 these small exposures now. And we're 22 introducing an effect which could look, in202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 fact, some subjects it can completely 2 overestimate the individual subject's 3 response. 4 Because some subjects actually 5 show an improvement after ozone exposure. So 6 maybe their airways are dilating or something. 7 I don't know. And they show an improvement. 8 So when you take the difference 9 between the decrement and improvement, you get 10 a larger decrement then is apparently due to

11 ozone. 12 So if you look at an individual 13 then, you could really overestimate the 14 decrement that ozone is causing when you're 15 looking at individuals. And that's really 16 what my concern is. 17 And that was, I think, brought up 18 at the last CASAC panel. And there's been 19 some discussion in this literature, I think, 20 also, by Adams, I think was one of the people. 21 So the question is what to do 22 about it and how to handle it. Is that Page 31

1 something you've been milling around in your 2 minds, also? 3 MR. LANGSTAFF: Yes, it is. And 4 there are several, well, there's more than one 5 way of adjusting for this effect of exercise 6 in clean air. 7 And one thing we've been 8 considering doing, and you can give us your 9 input on that, is just doing the analysis both 10 ways, calculating, for example, the population 11 exposure response function using the FEV1 12 decrements corrected for exercise in clean 13 air, and then without that correction, and 14 just seeing if it makes any difference. 15 Because it doesn't seem that it 16 usually makes much difference in the 17 aggregate. So it may not actually matter. 18 But it is an important point. 19 DR. ULTMAN: Well, wouldn't it 20 matter? I'm obviously concerned if somebody 21 if focuses in on a group of a few individual 22 subjects. If you do everything in the Page 32 1 aggregate, I think things can wash out pretty

2 well. 3 But the trouble is if people then 4 zoom in to look at individuals, that's what 5 gets me concerned. But at any rate, I think 6 that's a valid way of doing it. 7 There's another idea that 8 McDonnell has in his 2012 paper, which is kind 9 of buried at the end in a sentence or two. 10 And the way that he actually calculates his 11 percent delta FEV1, is he takes a study, a 12 complete study. 13 Well, it's more complicated than 14 that. But let's suppose that there's a 15 continuous exposure study which he's used. So 16 there's no time varying changes or anything. 17 So you just measure the pre and 18 post FEV1 changes, and what it does is he'll 19 take in that single study. He'll take all the 20 subjects' clean air exposures, and average 21 those. So he has a single clean air exposure 22 for the group of subjects. Page 33

1 And the advantage of that, as far 2 as the accuracy problems with the 3 instrumentation, which vary from day-to-day as 4 you average those out by grouping subjects 5 together. So that's another method you might 6 consider. Does that make sense?

7 DR. ULTMAN: Yes. I'm aware of

8 how he's done that. We have some concerns 9 about how that washes out the individual 10 variation in a way we might not want. But 11 we're looking at that. 12 MR. LANGSTAFF: Okay, good. Took 13 me awhile to really see through all this. 14 But, of course, you've been at this for a long 15 time. 16 Okay. So my bottom line is 17 there's clearly not enough explanation in the 18 current version of the REA. Because this 19 could be a very important issue. And 20 hopefully it won't be. But it could be an 21 important issue. 22 CHAIR SAMET: Okay, anything else,202-234-4433 Neal R. Gross & Co., Inc. Page 34

1 Jim? 2 DR. ULTMAN: Yes. I've got a 3 couple of things here. A lot of the comments 4 you'll just read on my comments, so it won't

5 matter. 6 I guess the McDonnell, Smith and 7 Stewart model is obviously very attractive. 8 But it overpredicts the current calculation9 you have, if I understand it, it not over10 predicts, I'm sorry. 11 In the current calculation, it 12 predicts larger values than the other method 13 did. And if that happened, then all the 14 calculations you did, that would become an 15 issue, I think, in terms of really why that's

16 the case. 17 So I assume that you're going to 18 be doing more comparisons to try to see if 19 that holds up or not.

20 MR. LANGSTAFF: That's correct. 21 Yes. We'll track down the difference for

22 that. Page 35

1 DR. HUBBELL: But there are 2 reasons why it's the case. We expect it to do

3 that. 4 DR. ULTMAN: With respect to the 5 question about age, whether the relationship 6 between age and delta FEV1, the function that 7 you're going to be using, which is just 8 basically you take 35 years old and take it 9 all the way out. 10 In terms of sensitivity analysis, 11 I think that's something that you should just 12 test in your sensitivity analysis. I don't 13 think there's much else you can do. 14 There are a few articles in the 15 literature. And those should be referenced 16 for people who have looked at the effects of 17 ages, two or three maybe. 18 There's not enough for you to do 19 anything in terms of data. But I think that 20 it should be mentioned and explained. And I 21 think the sensitivity analysis would be really 22 important. Page 36 1 Oh, and then the last point was, 2 if I understand correctly, you're using the 3 same exposure response formula, or model, for 4 adults, for children, and for children with 5 asthma. Am I wrong? 6 MR. LANGSTAFF: That's correct, we

7 are. 8 DR. ULTMAN: Okay. So basically 9 then, what that means is the risk analysis, 10 based on the human subject data, the FEV1 11 data, is going to be based on the difference 12 in their activity patterns alone.

13 MR. LANGSTAFF: And there's a 14 difference in physiology. 15 DR. ULTMAN: Oh, physiological -- 16 MR. LANGSTAFF: The ventilation

17 rates -- 18 DR. ULTMAN: -- physiological 19 parameters. Like ventilation, for example. 20 MR. LANGSTAFF: Right, and body 21 surface area, and so on. 22 DR. ULTMAN: Body surface area, Page 37 1 things of that nature, and activity pattern. 2 MR. LANGSTAFF: Right. 3 DR. ULTMAN: I think that's a huge 4 jump. This is intuitive. But to say that 5 children behave the same as adults with 6 respect to exposure response, well, maybe I 7 can buy that. And there is literature that 8 you quote that kind of backs that up. 9 But then when you extrapolate that 10 to asthmatic children, where I don't think the 11 data really exists to support that, then that 12 to me is a big jump. 13 And I would suggest that's another 14 area where sensitivity analysis is really 15 important, to see if there's any way you can

16 take a look at that. That's all I have. 17 CHAIR SAMET: Okay. Thanks.

18 Steve?

19 DR. KLEEBERGER: I don't have too 20 many things to discuss. Jack covered Question 21 1 fine. Most of my comments actually come in 22 Question 2.202-234-4433 Neal R. Gross & Co., Inc. Page 38

1 I had trouble with Table 6-4 on 2 Page 620. It wasn't quite intuitive to me 3 what exactly was being represented there until 4 I looked at it hard enough. And it was kind 5 of a reduction of percentage change. 6 And I can't offer a better way to 7 do it. But it was kind of hard for me to 8 figure out what exactly it was you meant in

9 that table. 10 Jack also mentioned, let's see 11 where are we in here with that, this gets to 12 page, hang on, let me go on to one other thing 13 first. 14 On Page 649, Line 1, the author 15 suggests that the lung function response 16 appears to level off after six hours of 17 exposure. And it's unlikely that longer 18 exposures would change exposure response 19 relationship. 20 But if you look at that figure 21 pretty carefully Schelegle's paper, in fact, 22 I don't think that's the case. I don't think Page 39 1 the response is, in fact, leveling off. 2 I think it's peaking at that 3 point. And I don't think we can actually make 4 that extrapolation out that a couple more 5 hours of exposure wouldn't make a change. In 6 fact, the change might increase rather than 7 level off. So I would be careful with that 8 interpretation. 9 Question 3, this is where I agree 10 with Jack. I think the rationale needs to be 11 clarified. 12 But I would also add that in 13 animal models, and I believe this is the case 14 in human subjects with controlled exposures -- 15 and Mike can address that when it's his turn - 16 - but the responses to ozone are not always 17 correlated. And in mouse genetics what that18 means is that the phenotypes do not co19 segregate. 20 And so someone who is very 21 responsive in terms of their FEV1 response, 22 may not be responsive to the inflammatory Page 40 1 response, and vice versa. And symptoms could

2 be the same. 3 So if you're basing all your 4 models on FEV1 changes, you may be missing 5 populations that are actually very 6 susceptible. But you don't detect that with 7 your FEV1 phenotype. 8 And so I think that needs to be 9 stated very clearly, that while re-using FEV1 10 there may be other populations that may model 11 very differently. And you may be missing 12 those with these models. 13 I think the other questions are 14 beyond my area of expertise. I've put a few 15 notes in my written comments. But those are 16 my major points. 17 CHAIR SAMET: Thanks. Mike?

18 DR. FOSTER: So I want to 19 reiterate. I think, Jack, Jim and Steve have 20 made some really good comments. I've written 21 up some really good comments for you people 22 and, I think, in a gentle form or way. Page 41

1 But I think I just want to re2 emphasize that in the ISA third draft there're 3 some comments about ethnicity differences that 4 Bill McDonnell's approaches have never taken 5 advantage of, or considered. 6 In addition, some of the databases 7 that Bill has relied on have not really 8 strenuously looked at whether or not obesity 9 in the database was a problem. And we know 10 from retrospective analysis obesity seems to 11 be a risk factor for an FEV1 change.

12 And then we know from the mouse 13 literature, and Stephanie Shore's stuff at the 14 School of Public Health at Harvard, that the 15 model data suggests that it's consistent with

16 the human data. 17 So I would like to emphasize that 18 you at least go back and look at that. And I 19 can easily provide you with the references, if 20 I haven't done that already. 21 I think the other thing that I 22 have concern about is actually in the second202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 draft. And I've made my comments clear, that 2 if you're relying on Ed Schelegle's paper, and 3 Chong Kim's, and I guess it's Milan Hazucha's 4 papers, they're very different profiles of 5 ozone exposure. 6 And some of those utilize 7 different minute ventilations. So the dose 8 response concentration, times dose, times 9 breathing frequency, will probably be very 10 much different in terms of the exposure times 11 metrics. So they should definitely be taken 12 into consideration. 13 The other point that I'm confused 14 about when I look closely at Ed Schelegle's 15 paper, is for each of the dose exposures that 16 he did, he started out with 30-plus patients. 17 But in every case they ended up 18 with 16 going for the entire 6.6 hours. And 19 I couldn't find any reason why there was such 20 a high drop-out rate. That's an extremely 21 high drop-out rate. 22 So I guess you can easily call Page 43 1 Schelegle and ask Ed what gives. Maybe 2 someone knows. There's got to be a response. 3 In my laboratory we never see that happen at 4 higher doses. 5 I guess the final thing is, so the 6 practice labs, you might have a subject come 7 in. You screen him, you put him on a 8 treadmill. You find out what their airway 9 responsiveness is based on FEV1. 10 They come back in for a 11 preliminary pre-measurement before and 12 exposure, whether it's filtered air or ozone. 13 We're actually doing seven visits now. So we 14 have a lot of preliminary data and it's in 15 large numbers. 16 Our paper last summer was 140 17 sample size, same equipment, same laboratory, 18 same technician, and skin testing. So the 19 careful approaches here is what you need to 20 think about.

21 And I understand the broadness of 22 Bill McDonnell's approach. But you also have Page 44 1 to go with where is the strength and the 2 precision in the controlled laboratory 3 studies. 4 And John, I brought in some 5 references to provide you with about the 6 ethnicity differences that I mentioned 7 yesterday in urban areas. But that's it. 8 Thanks, John. 9 CHAIR SAMET: Okay, thank you, 10 Mike. Questions? Sverre? 11 DR. VEDAL: Yes, I may have missed 12 it in the discussion. But I think you need to 13 have, I guess, some motivation as to why 14 you're focusing entirely on lung functions. 15 There's obviously a whole 16 literature on a host of other end points that 17 are controlled clinical study end points. 18 I understand why that's done. 19 It's quantitative, relatively easy to do, 20 relative to the others. But there's been a 21 change over time, and I think an appropriate 22 one, to relatively de-emphasize the lungPage 45

1 function findings. 2 It wasn't long ago when we were 3 talking about a risk assessment, and all we 4 talked about was spirometry. We didn't have 5 anything else to talk about. Well, now we do. 6 And I think in this context, I 7 think if you're not going to talk about 8 anything else you need to at least motivate 9 that, as to why you're not looking at the 10 other end points.

11 CHAIR SAMET: Fred?

12 DR. MILLER: I have several 13 comments. But let me just follow-up with what 14 Mike was bringing out about obesity in the 15 McDonnell model body surface area, I would 16 think, helps account for obesity. 17 The other thing about the latest 18 McDonnell paper is, that model is able to 19 simulate the results of every single clinical 20 study that's been done, whether it's square 21 wave, triangle exposure, step function, or you 22 name it.202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 So it's fairly robust in terms of 2 the differential equations that are in there 3 and the various parameters. 4 But I think Mike's point, in terms 5 of ethnicity, is a very important one. And 6 I'd have to reiterate that. And I think on 7 some of these others though, some of the 8 aspects of it are incorporated into the 9 modeling results. 10 I personally favor the use of the 11 McDonnell model because it allows you to get 12 at population level responses rather than 13 individual responses. And so that, to me, is 14 a significant stream. 15 On Page 610, the staff are talking 16 about the various probability scenarios, 17 90/10, 80/20, and 50/50. And I would say that 18 the 50/50 population scenario is definitely 19 not needed. And if you end up incorporating 20 the McDonnell paper, definitely not. 21 Because that split, in terms of 22 the areas of the two curves that you're trying Page 47 1 to represent the tolerance distribution, as 2 you would go to the ends of the population 3 curves, the tolerance distributions for 4 individual responses has a narrower 5 distribution. 6 If you go back to Finney bioassay 7 101, the tolerance distribution is very tight 8 on the end. And it gets broader as you cut 9 the planes in that. 10 So to assume a 50/50 is just too 11 much, 80/20 and 90/10, I think, cover the 12 scenarios you're concerned about in terms of

13 that. 14 So when we're talking here about 15 trying to cut down on the amount of work on 16 that, that's one that I think you could easily 17 defend not following up on. 18 The panel's in the paper in that I 19 have a suggestion for making it easier to 20 read. And what I would do is, right now you 21 have it split up for city and category of 22 decrements greater than ten, and so on. Page 48 1 And I would think that if you 2 rearranged it for a series of three figures 3 for each city followed by a set of three 4 figures for the next city, where in a given 5 city you have the results for school age 6 children, asthmatic children, and old people 7 for the FEV1 ten decrement, then the next set 8 for the greater than 15 and greater than 20, 9 then go to the next city. 10 Right now, to compare things, I'm 11 scrambling back and forth. And I think you 12 might look at that to see if that gave an 13 easier track to follow. 14 And in some of these, well, not in 15 this chapter as much, but in some of the 16 others, I would actually be advocating that 17 all of these figures be in an appendix and 18 that you only have one in the body of the text 19 that illustrates the points. 20 Because particularly in the later 21 chapters, you're going for pages that are 22 interjected with all kinds of figures before Page 49 1 you get back to the text explaining in that. 2 So it might help clarify following through. 3 Then I have just one other 4 comment. And that has to do with on 646 you 5 state, on Line 18, that there're going to be 6 three topic areas that they intend to perform 7 additional analyses. 8 And the first one involves 9 updating the exposure response functions with 10 new clinical data and comparing it to the 11 previous results. And I feel that's a waste 12 of the time. 13 The current is more robust. It 14 includes more studies in that. It's got to be 15 closer to the truth. To do it, to compare it 16 to the oldest, is saying we think we've gone 17 the wrong direction. We've made errors.

18 It's a more robust database. So 19 why waste time comparing it to something from 20 before. I just don't see that. 21 The second area involved 22 determining the relative importance of low202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 dose extrapolation by looking at the number of 2 percentages of people experiencing adverse 3 response. 4 And if you use the McDonnell 5 threshold model, that's going to assist you in 6 that task, as well as the third one that you 7 identify on that page. Because in his model, 8 you do have age as a factor that can be 9 incorporated. 10 I have some other specific things 11 but they're just with my general comments. 12 CHAIR SAMET: Okay, thank you. 13 Other comments on this? Okay. Then we'll 14 move on to Chapter 7, epidemiology. Sverre? 15 DR. VEDAL: I'm going to take a -- 16 CHAIR SAMET: Wait, wait. I'm 17 reminded that we need a volunteer, Jack, to 18 summarize the stuff here.

19 DR. HARKEMA: Thanks for 20 volunteering me. 21 CHAIR SAMET: Okay, thank you.

22 Sverre? Page 51

1 DR. VEDAL: I'm going to go 2 through -- 3 CHAIR SAMET: Do you want to 4 accept the nomination right now?

5 DR. HARKEMA: What's that? 6 CHAIR SAMET: Do you want to 7 accept the nomination right now? No, go

8 ahead. 9 (Laughter.) 10 (Off the record comments.) 11 DR. VEDAL: -- methodically, 12 unimaginatively, through the charge questions, 13 some of which I'll have very little to say

14 about. 15 The first had to do with the set 16 of epi studies for concentration response 17 functions and such. And I think, over time, 18 I've become convinced that the multi-city 19 study approaches are fine and using the 20 Bayesian shrinkage approach is fine, I think 21 is preferable. 22 It may not come out always, but Page 52 1 when you're using single city studies for some 2 of the functions, qualifying that based on the 3 fact that it is only one city, you do that 4 appropriately, I think, in most instances. 5 On the rationale for selection of 6 studies I think is good. I have no problem 7 with that. The uncertainty and variability 8 discussion, there was a lot of discussion on 9 the uncertainty and variability, and probably 10 because you're missing a lot of chunks from 11 what's going to be in the subsequent version 12 for other parts. 13 It's obviously very qualitative, 14 by necessity. And I've finally become 15 convinced that you just are not able to do a 16 formal probabilistic risk assessment, and this 17 was probably as good as you can do. 18 In ozone, in particular, one of 19 the big issues obviously is exposure 20 measurement error. And it's kind of 21 qualitatively different, I think, from the 22 other sources of uncertainty that you've dealt Page 53 1 with here, that you've dealt with quite 2 thoroughly. 3 I don't know quite how it could be 4 worked in to this type of a framework. But at 5 least some consideration of exposure 6 measurement error needs to be given to it. 7 Because there's such an element in the room, 8 particularly for ozone. 9 I understand the notion that we do 10 have a metric based on central monitoring 11 sites. And those are the sites that are used 12 in looking at attainment for the NAAQS and

13 such. 14 So it doesn't really matter in 15 some way what's sort of intervening between 16 those, but it does if you're actually looking 17 at it, you want to estimate a risk due to 18 ozone, in particular. 19 And we all struggle with issues of 20 what this actually means. What these 21 associations actually mean is that these low 22 concentrations, where we know that the202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 exposure to the susceptible population are 2 considerably different, probably a lot lower, 3 people who are inactive, indoors, none of that 4 comes out here. And yet it's a big lurking 5 area of uncertainty. 6 The things that you've dealt with 7 here I think you've dealt with quite well. 8 Exposure measurement error could also be a 9 source of what you described as variability, 10 as opposed to uncertainty, differences that 11 effect estimates regionally as a result of 12 potentially different degrees of exposure

13 measurement error. 14 The next section is on the results 15 of the risk analysis. And one point that I 16 was struck with, and I'm struck with it every 17 time I see it of course, is the very large 18 effects that are estimated for. 19 And in this example, that's used 20 in the risk assessment, is an exacerbation 21 where the percent of baseline risk 22 attributable to ozone varies somewhere between Page 55 1 12 and 20-some percent, which is big, right, 2 and may not pass the credibility test in some 3 sense. It's that big. 4 So it comes as a shock when you 5 find you're reading that. And obviously it's 6 based on the effect estimate from the Boston 7 study. And that's all you've got to work 8 with. But to the readers, looking at this, 9 we're not talking about changes in ozone 10 concentrations. 11 Your argument is that there was no 12 ozone, regardless of what else, it's 13 interactive with the cause of this. If you 14 remove ozone you're going to have huge 15 reduction in asthma exacerbations. So anyway, 16 it does strike the reader. 17 One thing that I was struck with 18 in this is also, and it's I wouldn't say 19 necessarily a style thing, there's a lot of 20 repetition. 21 And I guess specifically the 22 repetition comes in where it's almost a Page 56 1 formulaic approach, where you repeat things 2 with this is the current situation. And then 3 you repeat things when you go in the just 4 meeting the standards setting. 5 And then you repeat things again 6 when you into a summary. And the summary, in 7 some sense, is that the level of detail is too 8 great. It's almost the same level of detail 9 that was used in the original descriptions of 10 the results. So it's very repetitious and in 11 some way formulaic as you go through it. 12 The presentation of the ozone, the 13 distribution of ozone related mortality, I 14 don't know what everybody else thinks, but I 15 love the eMaps. 16 I know that they're just a 17 representation of the numbers that are in the 18 cells. But nevertheless, I think they're 19 great. 20 And I really like, and again, I'm 21 probably going to be in the minority here, I 22 love going to zero. I love seeing the back of Page 57 1 that, the zero percent concentrations that are 2 playing no role. And then as you march up 3 where it starts to kick in. And I thought it 4 was very informative. And so I'm a big fan of

5 that. 6 One thing that struck me was the, 7 and again it must have something to do with 8 the city estimates and the Zanobetti versus 9 Bell, she's not here, the Bell study, is so 10 dramatically different. 11 You have a very similar estimate 12 effect for New York. And then you look down 13 the tables and you go from like maybe, I don't 14 know, 70 deaths in L.A. And then in then in 15 the other study it's 500 deaths in L.A., 16 dramatically different. And maybe a little 17 point of discussion about that, because it's 18 so dramatic. 19 The refinements to the second 20 draft, and what you're planning to do and not 21 to do, I'm going to vote not to have you go 22 through a long term respiratory morbidity risk202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 assessment. That would be my take, based on 2 the findings. I think the rest is fine. 3 And then one final point, there're 4 a lot of studies that get this designation as 5 being the strongest bit of evidence and such

6 and such. 7 And in this setting, it's not the 8 nuance in asthma studies. It's the Lin study 9 from where it's the strongest of the long term 10 ozone exposure respiratory morbidity studies. 11 And you mess up the references 12 there a little bit. But that's a little issue 13 of tidiness. You either mean that's a really 14 strong study or that what else is out there is 15 really lousy. It's not that strong of a 16 study, and yet it comes off as being this 17 landmark kind of study. That's all I have to 18 say.

19 CHAIR SAMET: Good. Ana? 20 DR. DIEZ-ROUX: Okay. Let's see. 21 I have, I guess, some similar comments to what 22 Svere said. In terms of the selection of the Page 59 1 studies and the rationale, I agree with Svere 2 and his comments. I have nothing to add to 3 what he said. 4 In terms of the discussion of 5 uncertainty and variability, I thought you did 6 a very thorough, thoughtful job. That's what 7 you can do. I think it's very reasonable. 8 My main comments are related to 9 the presentation of the results. Our first 10 thing has to do -- and maybe because I'm an 11 epidemiologist, we can get a little obsessed 12 with terminology -- but some of the 13 terminology is very confusing, in terms of how 14 you're describing the effects. 15 And this is true in other parts of 16 the document too. Sometimes you talk about 17 total incidents when you should be saying 18 number of deaths attributable to. 19 So I would come up with some 20 standard terminology and then use it 21 throughout. Because it makes if very 22 confusing to understand what you're showing. Page 60 1 And it can be very simple, number 2 of deaths prevented, percent of deaths 3 prevented, reduction in absolute number of 4 deaths, percent reduction in absolute number

5 of deaths. 6 And that's basically what you 7 need, really. So I would go through all the 8 tables and the text, and then use a consistent 9 terminology that's more or less accepted by 10 most people in terms of describing these 11 different estimates. 12 And there might be ways, I think 13 the heat maps are fine. I didn't understand 14 why they were called heat or maps, because 15 they don't seem to have any of those things in 16 them. But I guess it's just a jargon thing. 17 But there might be ways that you 18 could streamline the results, at least at some 19 point, to get a bigger punch, and to be able 20 to more clearly show, summarize the findings. 21 And really what you need is 22 something like, you could have a table where Page 61 1 you have total number of deaths attributable 2 to ozone for your different cutoffs. 3 And I like going down to zero too, 4 myself, actually, total number of deaths 5 attributable to ozone, percent of total deaths 6 attributable to ozone, and then the absolute 7 and the percent reduction using different 8 standards. And that you could summarize 9 pretty succinctly, at some point, for each 10 city and then overall. 11 And that would give people 12 something where everything's together and you 13 can really see what the impact of this would 14 be. Even if you keep some of the more 15 descriptive stuff, I think having some summary 16 like that would be very useful. 17 Let's see, what else. Yes, and I 18 liked showing both the estimates going down to 19 zero and the lowest measured level. I thought 20 that was very informative. 21 And finally the last thing, this 22 question about the long term effects202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 estimates, I'm not as familiar with that 2 particular literature in terms of the long 3 term respiratory effects as others. 4 But given that it's such an 5 important cause of morbidity and the 6 population impact is so large, I would be 7 inclined to think about whether it's not 8 possible to show something, even with lots of

9 caveats. 10 That's my opinion. I'd be 11 interested in hearing what other people think. 12 But because the population impact of morbidity 13 from respiratory diseases is so important, I 14 would be inclined to perhaps consider that. 15 CHAIR SAMET: Okay, Fred. 16 DR. MILLER: Do you want only the 17 things relative to the charge questions now or 18 anything on seven in addition to the charge? 19 CHAIR SAMET: Feel free to go

20 ahead. 21 DR. MILLER: Okay. Well, first of 22 all, relative to the heat maps, I like them Page 63 1 also. But I would say that you need some more 2 interpretation, an explanation of them. 3 Because, for example, when you have the 4 alternative standards you have a shifting

5 down. 6 And it looks like by lowering the 7 standard you're actually causing more 8 mortality at lower exposure levels if you look 9 in the tables, which is counter intuitive, to 10 say the least. 11 The other thing is you might 12 consider the color scale. Right now, 47 to 72 13 deaths are represented by the same color. And 14 I don't know that you don't state the number 15 of death interval that you were matching up. 16 So get that in there. 17 And it might be possible to use a 18 more narrow scale in terms of, I don't know if 19 20 some deaths is the minimum when you 20 consider the overall. 21 But it just seemed like I might be 22 able to extract more out of the heat maps if Page 64 1 they not only explained their purpose a little 2 better, but also maybe to refine the color 3 scheme. That was just because of the last 4 couple of comments, that I would throw that in

5 now. 6 In terms of selecting the 7 appropriate studies for the concentration 8 response things, I think the document clearly 9 defends what they did. 10 They discussed the procedure that 11 you did for selecting them, including the air 12 quality information, the fact that CR 13 functions had to be available for the in-point 14 of interest and baseline health incident state 15 in that. And so I felt that was a very 16 strong, and it was up front, and it was very 17 good. 18 In terms of the rationale for 19 selecting in the specific studies, on Page 723 20 the four major criteria that you used to 21 select are identified. And it goes through it 22 very clearly. Page 65

1 I would not endorse addressing 2 long term exposure related respiratory 3 morbidity. I'm in agreement with Sverre on 4 that at this time, due to limitations in the 5 data available for such analyses. 6 And I think you're going to have 7 more than enough work to do without that. 8 Then you also talk about expanding and the 9 factors then that you considered in 10 identifying the effect estimates. And you 11 list six of those. 12 And the shape of the functional 13 risk model is something that might end up 14 needing a little more discussion if you use

15 the latest threshold model from McDonnell.

16 Because there'll be some text that would need

17 to be added there. 18 In terms of the qualitative 19 discussions of uncertainty, you've done an 20 excellent job, in my opinion, on either 21 identifying aspects that either contribute to 22 uncertainty or variability.202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 But I point out here, and I think 2 this page or whatever it is that you have got 3 where we can look at today, I strongly 4 recommend a prioritization of the different 5 tasks and what you can do. 6 And in my individual comments, I 7 have said what would be my priority. And I'll 8 be interested in hearing if the rest of the 9 panel agrees with some of those. 10 And right now they're spread out 11 in the document in this section and that. So 12 hopefully what you've pulled together here for 13 today will help us in aiding you to give you

14 our feedback.

15 In terms of the results of the 16 risk analysis, the 11 bulleted paragraphs in 17 Section 762 do a fairly good job of presenting 18 and discussing key results. 19 However, here's where the 20 illustration of the major findings, with some 21 simple graphs that convey the finding of the 22 recent condition scenario versus the scenario Page 67 1 where the current standards are just met,

2 would be useful. 3 The extra verbiage used to convey 4 all of these important findings is just 5 overwhelming. And so the old saying about a 6 picture is worth 1,000 words, if you can 7 develop a couple of figures you could really

8 save a lot there. 9 So I've already told you about the 10 heat maps. And in terms of the characterizing 11 overall confidence, two pages in the document 12 are devoted to characterizing the overall 13 confidence in the risk assessment and risk 14 estimates derived from these studies. 15 The five topics that you discuss 16 appear to be relevant. However, I don't 17 understand why the log linear no-threshold 18 model was used for the full range of exposures 19 down to zero, as this belies the real issues 20 that need to be addressed, that a risk above

21 the PRB. 22 And I would grant Sverre having Page 68 1 one scenario where you go to zero. But this 2 bridges into one of my major concerns about 3 the current analyses that are in this document 4 in the policy assessment. 5 And that is not having estimates 6 of the contributal risk above some definition 7 of policy relevant background. To me, this is 8 absolutely necessary because you have to 9 understand what part of the total risk is 10 controllable by any kind of regulatory action. 11 And without that, you just can't 12 make that. And I feel so strongly as to say 13 you're inviting litigation to the 14 Administrator of the agency without doing 15 this. 16 Because as we get to lower and 17 lower levels, to set a standard where it's 18 below the background levels that exist would 19 be arbitrary and capricious, in terms of the 20 Clean Air Act's wording in that. So somewhere 21 it's got to be included here. 22 And right now, you only go to the Page 69 1 LMLs. And the LML, as I indicated yesterday, 2 and I think it's Table 75, the LMLs in all of 3 these epidemiology studies are a factor of 4 three to five lower than what you present 5 earlier in the document for the regional 6 specific North America background or U.S. 7 background, and so forth. 8 And so to talk about risks from 9 the LML up, in the epi studies, is to me also 10 incorrect. It's got to come about from some11 definition of what you think is the non12 empathogenic contribution, and what that level 13 is, and then what are the risks above that. 14 So if I were endorsing two 15 scenarios, it would be down to zero for the 16 total risk. And then define, if you're going 17 to use North America background or USA 18 background, or what, but show the attributable 19 risk reduction that could occur with the 20 alternative standards that incorporate those 21 different background definitions.

22 And I don't understand here the202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 relative importance of U.S. versus North 2 America background to that, which might be 3 more defensible or more appropriate. That's, 4 I think, in Danielle's bailiwick more than 5 mine. 6 But this is clearly, to me, a 7 major problem, with the current set-up of the 8 analyses, that is just inviting trouble. 9 I like the higher order decoupled 10 method. And we had a little bit of discussion 11 yesterday about the pros and cons. And in the 12 current document, it's not made clear how you 13 would go about, then, estimating risks above 14 some particular cut point. 15 I know it can be done and I had 16 separate discussions. But right now the 17 document just doesn't cover that. 18 So in terms of a couple of the 19 other things, there's a couple of other areas 20 in terms of the number of sensitivity 21 analyses, and that's in Section 7.7.1, that 22 you might look at at the second, they're Page 71

1 discussed there. 2 And here again, I feel a need to 3 prioritize because I just am convinced there 4 isn't enough time and aren't enough resources

5 to do all of them. 6 And my own prioritization would be 7 to prioritize the short term exposure related 8 mortality, then the short term exposure 9 related morbidity, and lastly, by 10 interpolation of missing air quality data. 11 I think the missing air quality 12 data is just going to be masked by the 13 importance of the sensitivity analyses of 14 those first two. So here again is an area 15 that I would suggest putting the lowest 16 priority to trying to get to. 17 I also wondered, in terms of the 18 national study, if right now they're all 19 divided up into the different cities. And 20 then you do the total. And I'm wondering 21 about if you could have some overall 22 quantitation where you weight these by the Page 72 1 population that's at risk in these areas. 2 Because you have different 3 mortality estimates. And, as Sverre brought 4 up, the difference between the Bell and the 5 Schwartz things are quite large in some 6 instances. 7 I think you've explained that it's 8 primarily due to what was the definition of 9 the ozone season in those two different 10 studies. One included many more months, and 11 one was only July, August. Isn't that not

12 true? 13 DR. VEDAL: It's true but it's not 14 going to be an issue. 15 DR. MILLER: Okay. Well, it 16 certainly would need to be adjusted for that. 17 And then there may still be differences. But 18 I'm not sure they'd be as large as they are

19 now. 20 So that kind of weighting, to make 21 comparisons between studies that did different 22 things, there might be something that helped Page 73 1 to put that into perspective. 2 Let's see, I think that covers 3 most of the major things. I have some 4 specific comments that I'll convey as far as 5 some of the other points that can help the 6 clarification. 7 CHAIR SAMET: Okay, Zach? 8 DR. PEKAR: We just, I think, 9 wanted a little bit of a follow-up on one of 10 the points that you made. I think because 11 this has been mentioned a couple of times at 12 the McDonnell study. 13 If you have a clinical study that 14 shows some of evidence for a threshold, I 15 think, the challenge of translating that into 16 a threshold within an epi based response 17 function, where you have a generalized 18 exposure surrogate based on monitoring data 19 versus a very specific clinical exposure 20 level, I understand that gives us some 21 information we might want to try to use. 22 But the bridge between those202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 technically can be pretty challenging. And if 2 there's any advice that the committee would 3 have for how we could bridge that, that 4 technical gap, that would be very much 5 appreciated. 6 DR. VEDAL: It's not a gap you 7 need to bridge. 8 DR. PEKAR: Okay. 9 CHAIR SAMET: Sverre, use the mic. 10 DR. VEDAL: It's not something you 11 need to bridge. There are qualitatively 12 different than what you learned.

13 Whether there's a threshold model 14 in the controlled exposure studies for FEV1 15 probably has no relevance to whether there's 16 a threshold for other end points, and in the 17 epi studies as well. I wouldn't generalize 18 that observation to the other risk estimates.

19 CHAIR SAMET: Comments from others 20 on this chapter? 21 DR. DIEZ-ROUX: I have, actually, 22 maybe a clarification question. So my Page 75

1 understanding is when you're estimating the 2 health benefit attributable to just meeting 3 the standard, and then you'll do it further, 4 you are considering the background, right? 5 Because you would generate the 6 exposure distributions, background is 7 considered in that, right? It's not reduced 8 below the background level. It's adjusted. 9 Is that correct? Is my understanding correct? 10 So it is incorporated into the estimation?

11 DR. PEKAR: That's correct. 12 DR. HUBBELL: It's incorporated. 13 So we're not disingenuous about this, I don't' 14 think that's what Fred was getting at, at all. 15 DR. DIEZ-ROUX: So what were you 16 getting at? Can you clarify? 17 DR. MILLER: A portion, while it's 18 incorporated, then they show the total risk. 19 But they don't show, of that alternative 20 standard risk, how much of the total of that 21 is due to exposures above the policy relevant 22 background levels. Page 76

1 DR. DIEZ-ROUX: In terms of 2 estimating the overall health impact of ozone, 3 I don't think the background levels should be, 4 I disagree with that. I don't think it should 5 be the boundary below which an effect is not 6 estimated. 7 Because, in fact, the background 8 levels differ across the country quite a bit. 9 And there's no reason to assume some places 10 will achieve a lower level. And that has a 11 health benefit. Why should we ignore that? 12 DR. MILLER: But that's just 13 exactly the point, there's region specific. 14 And when they're doing their 16 city studies, 15 in that they're in vastly different geographic 16 regions, and we have the background data by 17 season in that, so that you can make that 18 adjustment. And to use one overall value, 19 it's not going to cut it anymore. 20 DR. DIEZ-ROUX: But when they 21 estimate the health benefit, they are 22 accounting for the background variation across Page 77

1 races. Isn't that correct? That's correct. 2 DR. MILLER: It is. But you're 3 still not identifying the fraction of risk 4 that is attributable to exposures above the 5 background. And that is what is going to come 6 into the policy assessment by the 7 Administrator, of within whatever range the 8 science says you could consider, how confident 9 they are in moving that. 10 DR. DIEZ-ROUX: And they're 11 assuming -- 12 DR. MILLER: And the agency has 13 talked here about looking at the levels below 14 60 parts per billion. It's an absolute waste 15 of time, in my opinion. 16 And this has to do with the 17 Administrator having the data to make the 18 judgement about how much of this risk is

19 controllable.

20 CHAIR SAMET: So a comment here. 21 I think we need to return to the general 22 policy related background issue. And probably202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 the right time to do that is when we get to 2 Chapter 9 in the synthesis. And I think I 3 understand the points of everybody. 4 But I think there's issues here 5 around how the calculations are done, and then 6 how they may be interpreted in light of 7 alternative scenarios that come into the 8 policy analysis, which I think is what Fred is 9 getting at, and where those estimates will 10 come from, in fact, for apportioning the risk 11 for policy consideration. 12 So I think we need to circle back 13 to this, in light of the discussions yesterday 14 and today. 15 DR. DIEZ-ROUX: I think clarifying 16 exactly how background is being utilized in 17 these estimates is very important. Because we

18 need to understand that and make sure we all 19 have the same understanding of it. Because 20 otherwise I think we may be talking about 21 different things. 22 CHAIR SAMET: This is actually one Page 79 1 of those places where a figure would really 2 help, showing zero, what you're doing in 3 background eventually in 16 locations, I 4 guess, and then other considerations as you 5 impose policy scenarios onto this for a 6 portion of the risk. Which I think is what 7 Fred is getting at. Because you are 8 calculating 16 specific -- 9 DR. HUBBELL: Yes. To clarify 10 very specifically, we are using background 11 right now as a floor. And even in the HDDM 12 approach, basically it would be incorporated 13 into the model, where you would not reduce air 14 quality below natural background levels in 15 calculating differences between scenarios. 16 What we're not doing, is we're not 17 apportioning risk into risk occurring due to 18 exposures below background and risk occurring 19 due to exposures above background. 20 So we're not apportioning, but 21 we're taking into account background when we 22 simulate just meeting the current standard or Page 80 1 alternative standards. That's the major 2 difference. 3 And I think it's a very clear 4 difference, and it was a direct decision that 5 we made. It was not an accident. It was a 6 decision we made. 7 And that's why we think it is very 8 useful to get all the input we can on this. 9 But to be clear, we are incorporating it in 10 our simulations. And it's just not called out 11 as a separate attributable factor. 12 (Off microphone comments.)

13 DR. HUBBELL: Yes. 14 DR. VEDAL: Not to belabor this 15 issue, but I think we need to come back to the 16 issue. Because this issue does sort of touch 17 on the issue of feasibility. And just like 18 risk benefit, it's something where it's sort

19 of a no-no. 20 And so the question I have is, is 21 it appropriate to be talking about something 22 like policy relevant background, whatever Page 81 1 background you want to use, given that it is 2 actually a topic relating to feasibility of a

3 standard. 4 MS. WEGMAN: And as I said 5 yesterday, in setting the standards we don't 6 take the feasibility into account. But it is 7 a separate question on which we would like 8 your advice on how we should reflect, if we 9 should reflect, background in looking at the 10 risk estimates, and also in thinking about

11 standard levers. 12 That's a question we have not 13 taken on in the first draft of the risk and 14 exposure assessment or the policy assessment. 15 And so this discussion is 16 extremely helpful to us and the further 17 discussion will be as well. But it's not from 18 the standpoint of feasibility. 19 CHAIR SAMET: Okay, back to 20 Chapter 7, other comments? 21 DR. VEDAL: One little suggestion 22 that I might make, I think Fred also brought202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 it up, relating to this issue of repetition. 2 When you go from current 3 situations to just meeting the standard, one 4 way of avoiding that is to say, looks exactly 5 the same except for blah, blah, blah. And 6 then you avoid that formulaic presentation.

7 DR. HUBBELL: And we also take 8 into account the suggestion of trying to use 9 some summary tables, rather than doing it in 10 the text, which just leaves a lot of 11 repetitive text. We take into account for

12 sure. 13 CHAIR SAMET: Chris? 14 DR. FREY: I had maybe a 15 clarifying question for Bryan. So I think 16 you did a nice job explaining how the 17 background is accounted for in the rollback 18 approach. 19 And this is jumping ahead a bit. 20 Maybe we ought to defer it. But my question 21 is at some point we're going to talk about 22 what levels you ought to analyze. Page 83

1 And it could be that because of 2 regional differences in background, one city 3 might be able to go to a lower level than 4 another city. Have you thought about that or 5 anticipated how to handle that? 6 DR. HUBBELL: Obviously, again, in 7 each city we'll have a different estimate of 8 background. And, again, because we're not 9 focusing on the feasibility, in the case of 10 HDM we'd be focusing on what are the NOx or 11 VOC or a combination of NOx and VOC that would 12 lead to just meeting the various different 13 alternative standards. 14 And we're not really going to be 15 discussing the feasibility of getting those 16 particular reductions actions, we're simply 17 identifying the sensitivity of the atmosphere 18 to those reductions in emissions. 19 So we would take it into account 20 but it's not a discussion of feasibility. 21 It's just a discussion of how sensitive the 22 atmosphere is to those reductions. Page 84

1 CHAIR SAMET: I'm sure we'll come 2 back to this. Fred? 3 DR. MILLER: There's another word, 4 though, that you need to consider. And that's 5 the uncertainty. And as you go to lower 6 levels you're charged with characterizing 7 what's the amount of uncertainty. 8 And I submit, without having this 9 apportionment of the risk into above 10 background and below for whatever the area is, 11 that you are masking the amount of uncertainty 12 that's present. And so there's more than one 13 way to skin a cat in defending what I'm 14 proposing. 15 CHAIR SAMET: Okay. Let's go on 16 to Chapter 8. Chris? 17 DR. NUGENT: Before we do that, do 18 you have anything -- 19 CHAIR SAMET: Oh, yes. I thought

20 I heard Sverre volunteer. 21 (Off microphone comments.) 22 DR. FREY: So Sverre's going to do Page 85 1 Chapter 8 also, is that -- 2 (Laughter.) 3 DR. FREY: Okay, I wanted to make 4 one observation before I get into Chapter 8, 5 which is that on the general issue of 6 uncertainty, just thinking back, even in my 7 limited time on CASAC, I think EPA's made a 8 lot of progress on this. 9 And I just thought it would be 10 worth pointing that out. We've heard a lot of 11 very positive comments about what EPA's done 12 with uncertainty. And certainly the comments 13 are much more positive than they were some 14 years ago. 15 So there's a very nice positive 16 trend. So I just thought it was worth saying 17 something nice, and congratulating you guys 18 for doing a good job. 19 Okay, so Chapter 8 has to do with 20 the national risk assessment. And I think 21 some of the issues are probably similar with 22 the city scale risk assessments.202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 And as a reader of Chapter 8, I 2 read Chapter 8 and then I went back and read 3 the rest of the document. So I can tell you 4 my reaction to Chapter 8 as someone who picks

5 and chooses what to read. 6 And I found the conceptual 7 framework lacking in Chapter 8. It would have 8 been nice, and maybe it's just a paragraph, if 9 you just channel Bryan Hubbell for a 10 paragraph, I think. You do a good job 11 explaining these things at the meetings. 12 So if we have a Bryan Hubbell 13 paragraph, or whoever it is, that just says 14 what is the conceptual framework for this in 15 terms of, in particular, thinking of the 16 issues that we just talked about, like 17 background and LML. 18 And as a reader, I can tell you it 19 was extremely confusing to me what the concept 20 was for the national scale risk assessments 21 with regard to those two issues.

22 So I don't want to belabor that Page 87

1 because we've talked a lot about that. But I 2 think a similar thing applies to Chapter 8. 3 After reading Chapter 8, and then 4 reading the whole document, and then hearing 5 some discussion, I think I finally figured out 6 why there's the elemental analysis and the no 7 elemental analysis. 8 But if you're going to have it, it 9 would be nice to say it up front. Because all 10 the detail in the world means nothing to a 11 reader who can't figure out why this is being 12 done. And having said that, I guess I'm not 13 entirely convinced of the need for the LML 14 based analysis. 15 I guess the idea, this is my 16 interpretation, is that the epidemiological 17 models are based on really looking at 18 differences in response versus differences in 19 concentration over some range of observed 20 concentration. So we don't have observations

21 below the LML. 22 And then there's the side issue Page 88 1 of, well, EPA didn't actually use the LML for2 each epi study. They used a generic one-size3 fits-all LML. 4 And that's maybe a secondary 5 concern is how valid is that. And so maybe 6 the model's not valid for concentration 7 differences down at that range. 8 On the other hand, if we're 9 predicting absolute number of incidences, the 10 epi model does do that in the range of 11 concentrations observed. So to then apply it 12 only above the LML, I guess I would have to 13 rely on the epidemiologist. But it almost 14 seems like that's a bias. 15 So, I don't know. As a reader it 16 would help me to understand the thought 17 process behind why that's being done. And 18 it's sort of described as it gives a bounding 19 analysis, that with and without tells you 20 something about the uncertainty. 21 But I'm not totally convinced of 22 that. But I'm not an epidemiologist. So I Page 89 1 would really like for an epidemiologist to 2 weigh in on that. 3 Let's see. So then on Chapter 8, 4 I wrote a lot of detailed comments. And I'm 5 not going to go through them in detail. A lot 6 of them are technical comments but they 7 pertain to very specific things. 8 So I think my general comments on 9 Chapter 8 are really just two things. One is 10 what I just said. And the other is there's 11 some discussion of different exposure metrics. 12 And I know that two of the epi 13 studies that are used prominently actually use 14 some slightly different exposure metrics in 15 terms of one was based on May through 16 September data. The other was June through 17 August data. 18 And I don't know if the EPA's 19 already done this, but wouldn't it be possible 20 to do some quantitative assessment of the 21 correlation between those, just to get an idea 22 of their similarity or were there differences?202-234-4433 Neal R. Gross & Co., Inc. Page 90

1 I know there're some other 2 differences in those studies, that one is 3 based on non-accidental mortality and the 4 other's based on total mortality. 5 And those differences, I think 6 the chapter does a pretty good job of 7 conveying that. I think there's one place 8 where it forgot to do it. And I made a note

9 of that. 10 So otherwise I thought, in 11 general, the approach was reasonable. I 12 actually really liked the assessment of the,

13 let me double check so I make sure I remember 14 the right chapter, so this is the chapter

15 where we have the assessment of the 16 representativeness of the city specific 17 studies. 18 And I thought that was really 19 nice. That was a nice part of the chapter. 20 I thought that was pretty well done. 21 One thing I was thinking is to 22 extend that, it seemed to be written focused Page 91 1 on mortality and how the city-specific 2 modeling is representative with regard to 3 mortality. 4 But I think one could extend that 5 to the representativeness of those activity 6 patterns related to morbidity end points as 7 well. So that's just a suggestion. That's 8 it. 9 CHAIR SAMET: Okay, Ted? 10 DR. RUSSELL: I think one problem 11 with having two engineers doing a review on 12 this one is that very similar comments and 13 similar approaches. 14 I read Chapter 8 first and then 15 went on to read the rest. And like Chris, I 16 started to read Chapter 8 as it sits. And 17 you're wondering why a lot of these decisions 18 were made and what some of the alternatives

19 would be. 20 And I think that just has to be 21 cleaned up in terms of how Chapter 8 really, 22 why they've made their decisions, link it Page 92 1 better to Chapter 7, and how Chapter 7 really 2 motivates some of this. 3 I would still start out with 4 bringing stuff from the ISA about the causal 5 determinations, and how this pushes you 6 forward, just for people like me who might 7 start with the Chapter 8. 8 Going on, actually some of the 9 little things, the way the introduction really 10 doesn't set up well the whole chapter, that 11 was another thing I found. 12 You really don't talk about 13 anything that's going to be happening with the 14 considerations with the Jerrett, et al study. 15 And you don't talk about, again, 16 what I thought like Chris said, the analysis 17 of the representativeness. That's not really 18 captured in the introduction either. And it's 19 a great piece that you've done there. So I 20 think that should be brought in. 21 And then another thing that just, 22 and I find this elsewhere in the document as Page 93 1 well, is that you make a statement like we 2 also have high confidence in extrapolating the 3 national average effect estimates. 4 And I don't know why you have high 5 confidence versus medium or low or whatever, 6 particularly if you've read Chapter 7, the 7 Bell, et al. and Zanobetti and Schwartz, you 8 got different results. 9 We understand why you got 10 different results, but usually when you get 11 really different results that would decrease 12 your confidence in it. 13 Now it turns out, in Chapter 8, 14 that you get remarkably similar results. And 15 I would bring that out in a summary of Chapter

16 8. 17 If two of my students did these 18 two analyses using different time periods, and 19 using different effect estimates, and came out 20 with estimates that close to each other, I'd 21 be amazed. And I think that can be brought 22 out some. So those are my comments on this.202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 CHAIR SAMET: Okay, Ed? 2 MR. AVOL: So I have some minor 3 comments that are in the submitted text. And 4 actually I've updated them so I'll submit an 5 updated version. 6 But I do have one question for 7 you. In reading this, the issue about 8 applying the national average estimates and 9 the grid cells, downwind of urban for rural 10 areas, et cetera -- and maybe just because 11 it's not my particular field -- but it seemed 12 like that seemed to not quite set with me 13 completely for the following reasons. 14 I'm not a demographer, but as far 15 as I understand the population is not randomly 16 and uniformly distributed across the country. 17 And there are lots of other reasons, social 18 reasons, for why there are more people living 19 around Los Angeles, maybe, and Houston, than 20 some other places. 21 Those have higher pollution values 22 and so people downwind are going to have Page 95

1 higher exposures applying national averages.

2 I'm not sure whether I'm more 3 concerned about people downwind of places like4 Los Angeles and Houston, that then get under5 assigned in national averages, or people that6 are downwind of other places that get over7 assigned in more open. 8 You do say that in the text. And 9 if you go forward and look at assigning the 10 nearest urban area and using that approach, 11 which made me think that was a more relevant 12 approach, so why even do the national 13 estimate. 14 Why not do some sort of assignment

15 or assessment of areas based on the nearest 16 urban area and use the best available 17 information. It seems to me that's better 18 information and a better estimate in some

19 sense. 20 DR. ANENBERG: So our rationale 21 for applying the national average estimates to

22 the rural areas was that we could take Page 96 1 advantage of the broader population, the 2 broader exposure characteristics, given that 3 we do here have lower confidence in 4 extrapolating the epi effect estimates that 5 were based on urban study areas to rural areas 6 with very different populations. 7 We can consider using a different 8 method to do that. In fact, I think one CASAC 9 member suggested that we, as a sensitivity 10 analysis, apply the lowest urban effect 11 estimate and the highest urban effect estimate

12 and see how that effects the results. 13 And I think perhaps that would be 14 a useful method of getting at how the 15 sensitivity falls out here. But I would look 16 for your advice on that. 17 MR. AVOL: Right. I think that 18 sounds like a reasonable thing to do. 19 Because, again, there was a lot of discussion 20 about uncertainty and variability in all these 21 sorts of issues. So that would be a good 22 application for that consideration. Page 97

1 DR. ANENBERG: Sure. 2 CHAIR SAMET: Anything else to 3 add? Okay, others? Comment on this, Chapter

4 8? Fred? 5 (Off microphone comments.) 6 CHAIR SAMET: Is your name Fred? 7 (Laughter.) 8 DR. MILLER: Please, let him go 9 ahead, please. 10 DR. VEDAL: I wonder if we 11 shouldn't just extend the discussion of using 12 the lowered, the LML, in the utility of that. 13 When I read things I was convinced 14 that there was utility to it. And they were 15 basically for the reasons that Chris said, not 16 extrapolating beyond where there's data, and 17 then giving more of a real world scenario. 18 But I think your comment, in terms 19 of when you look at the heat maps, that is the 20 real world distribution and concentration. So 21 that point really doesn't hold water. 22 It's really an issue of202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 extrapolating beyond the data and whether 2 there's utility in presenting effects where 3 arguably you might have more confidence in the 4 estimate. 5 I think that's probably the extent 6 of it. And so the issue is whether that's 7 reasonable, given that now we may be 8 recommending, well, who knows what we'll 9 recommend, but whether we'll recommend other 10 estimates that are based on some notion of 11 background as well. 12 And then whether we should just 13 limit it to down to zero versus addressing 14 something related to background, or whether 15 there's some additional utility to having this 16 intermediate concentration, which is the LML. 17 I don't feel strongly about that. 18 I expect we're going to be swamped with a lot 19 of different estimates if we include all of

20 them. 21 DR. MILLER: Okay. I had several 22 comments in reading this chapter. There's a Page 99 1 lot of duplication of material. There's a 2 couple of paragraphs, for example, in 8-1. 3 And then it's basically repeated in 8.1.3. 4 And so put it one or the other, but I don't 5 think you need to have the amount of detail in

6 both. 7 The figure, 1.9, it could benefit 8 from being re-drawn to have the same color for 9 the Bell study, the solid red line in the dash 10 colors using the different cutoffs, that 11 ordinarily you're used to seeing for a given 12 study. 13 And then if you do alternatives 14 with that, it's the same color but a different 15 form. So you're correct in what you present, 16 but it would just be easier for people to

17 follow. 18 I had a suggestion too on 845. 19 You discussed the ATUS data, and about using 20 that in the second draft. And I would give it 21 a very low priority, given the problems with

22 the data. Page 100 1 And so if you're looking for 2 cutting down work that, to me, it's one of the 3 sensitivities that could drop out. 4 And then I always learn things at 5 these meetings. But the last thing I'd like 6 to ask is education in your tables, where you 7 present population per square mile. Is the 8 square mile determined as the crow flies or 9 from topological maps? Because it makes a 10 hell of a difference.

11 DR. ANENBERG: I don't know the 12 answer to that at this time. We took that 13 from the Census Bureau. And I can get back to 14 you on it.

15 DR. MILLER: Yes. It makes a 16 tremendous difference. And so I'm just 17 curious which it is. If it's just as the crow 18 flies, it's useless. 19 Look at Cincinnati and the ups and 20 downs of the hills versus as the crow flies, 21 and the density per square. So I hope it is 22 topographical, but I wouldn't count on it. Page 101

1 DR. ANENBERG: We can check that. 2 CHAIR SAMET: Okay. Other 3 comments on Chapter 8? So let me get a sense 4 of a couple of things. We're running ahead of 5 schedule, which is okay. Kathy Weathers was 6 coming --

7 DR. NUGENT: About 11:30.

8 CHAIR SAMET: About 11:30. We

9 need a break somewhere. We need to talk about 10 Chapter 9. And then, Bryan and Lydia, this 11 list of things to do, when might we see that? 12 DR. HUBBELL: Well, we have the 13 draft of that ready. We needed to make a few 14 little modifications and then we're going to 15 give it to Angela. We just haven't had a 16 break yet. So we thought we're going to do it

17 at a break.

18 CHAIR SAMET: So let me make a 19 suggestion. I think Chapter 9 might go pretty 20 quickly, well, might not. All right, a break 21 until 10:30. 22 (Whereupon, the above-entitled202-234-4433 Neal R. Gross & Co., Inc. Page 102

1 matter went off the record at 10:13 a.m. and 2 resumed at 10:33 a.m.) 3 CHAIR SAMET: We are at Chapter 9, 4 Synthesis, and let's see, Michelle, you're the 5 -- I'm sorry, Fred. 6 DR. MILLER: I had one more point 7 about Chapter 8, before we get off of it. To 8 me, there wasn't an adequate explanation in 9 this document why the authors deleted the two 10 highest cities in the Bell study from the 11 analysis that they were doing. I would like 12 a clarification of what was the problem as to 13 why those two highest city studies were 14 eliminated. 15 DR. ANENBERG: If I could just 16 clarify that really quickly, it wasn't deleted 17 from our study. It just wasn't captured in 18 urban study areas that were selected for the 19 urban study area analysis. 20 DR. MILLER: Okay, thank you. 21 CHAIR SAMET: Okay, Chapter 9 -- 22 lead reviewers for 8, Sverre, you don't have Page 103 1 to do 8. Chris, would you?

2 DR. FREY: Sure. 3 CHAIR SAMET: Okay. 4 DR. BELL: All right, so I think a 5 lot of the comments that I have for Chapter 9 6 are going to echo some of the other comments 7 people have made about the document in 8 general. 9 So I know that each chapter is not 10 a standalone document. But I do think that 11 it's useful to think about what kind of 12 impression it would give if someone just read 13 that chapter, because that's quite possible. 14 And the issue of the policy 15 relevance of going down to zero really comes 16 up in this chapter and it's not described at 17 all. So my strongest recommendation for this 18 chapter is to discuss the policy relevance of 19 going down to zero. 20 And I agree with Chris's comment 21 about channeling Bryan Hubbell, because when 22 you explained what that was done in the, you Page 104 1 know, the partitioning or distinction not to 2 partition between anthropogenic and biogenic 3 emissions, that was more clear than the text 4 in this chapter. 5 So I think this was just a matter 6 of adding that in. But I think it's really 7 important to think about that, but especially 8 for the policy relevance of going down to 9 zero. Because if you haven't read the other 10 parts of the document, I think it would make 11 no sense at all if you just read Chapter 9. 12 I also thought that, I know this 13 is kind of an early draft, but I thought some 14 of the word choices were maybe not the best. 15 And I made some specific comments in my 16 written comments. But just to give some 17 examples: the word "significant" is used in 18 the context of something other than 19 statistical significance. That's easy to fix, 20 if you use "substantial" or something else. 21 And talking about two cities, when 22 you're looking at results from four studies Page 105 1 and two studies identified three of those, the 2 same three to have the highest effect and then 3 go on to say that's a significant difference, 4 that's really confusing. 5 So I think this is another case 6 where I suspect EPA really does have something 7 very reasonable in mind. But you just need to 8 fix the wording. 9 And there are other places in here 10 where I wasn't sure if it was a wording choice 11 or a conceptual difference. So I wasn't sure 12 if everything in this chapter was really what 13 EPA meant to say. 14 And one example is where it says 15 that the urban areas provided good 16 representation of the overall distribution of 17 risk. I mean, they clearly don't, right, 18 because we don't have estimates for rural

19 areas? 20 And so there's sentences like that 21 as an example where I'm not sure what you 22 mean. So I would just check the sentences to202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 make sure they're what you mean. 2 And another example, just to help 3 readers along, it talks about not specifying 4 U.S. background concentrations because it's 5 incorporated in the modeling. If I didn't 6 know anything about that modeling, I wouldn't 7 understand because you have to specify stuff 8 for the model. So I think you could use 9 language like, "it's estimated by the model", 10 just so that the reader understands what's 11 going on. 12 And then other places were a 13 little bit vague, like there's talking about 14 an improved approach in a few places. 15 Improved, improved how? I think that could be 16 expanded upon. 17 So I thought this was a good start 18 but the main comments are just better 19 explanations and to be really careful about 20 the word choices, and also given the21 complexity, just to maybe give it one read22 through and pretend you're a reader who hasn't Page 107 1 read the other sections. And just make sure 2 there's nothing there that's going to be taken 3 out of context later. And those are my key 4 points. 5 CHAIR SAMET: Chris? 6 DR. FREY: Okay, yes, so reviewing 7 Chapter 9 it's, as Michelle points out, it's 8 kind of hard to do that without commenting on 9 the document in its entirety. I guess I'll 10 start with my comments that are specific to 11 Chapter 9 and then I wanted to talk a little 12 bit about the issue of the background. 13 So I wrote some detailed comments 14 on Chapter 9. I'm not going to go through all 15 of them but, there's a couple of places in the 16 document, like in here it says, "APEX lacks 17 proficiency to model repeated exposures." And 18 I don't know if "repeated" is meant to mean 19 longitudinal, I guess that's the word I'm more 20 used to seeing, but I assume that's sort of 21 what it means. 22 And there's some other language, I Page 108 1 think it was in Chapter 8 I didn't mention, 2 but it says something like, APEX, you know,

3 there's some statements about APEX that I 4 think were actually unnecessarily negative, 5 you know, that exposure is largely unknown 6 and, you know, so I think on these issues it's 7 not that it, for example, it's not that 8 exposures are largely unknown, I know that's 9 mentioned in Chapter 8, it's just that there's 10 some uncertainty in estimating exposure. I 11 don't think that means we can't make useful 12 estimates. 13 In the case of proficiency to 14 model longitudinal exposures, my thought is 15 that's not really an artifact of APEX, that's 16 an artifact of CHAD, it's really the input

17 data. 18 And to me that's an important 19 distinction. As someone who started my career 20 as a modeler, I'm very sensitive about people 21 criticizing models for what they can't do when 22 in fact, well, the model could do it, we just Page 109

1 don't have the data. It's not that the model 2 is misspecified. 3 And I guess the practical 4 implication is if you wanted to fix it, the 5 way you would fix it would be probably to get 6 more data for CHAD. If you had that data, you 7 could account for it. 8 So I think some discussion, and 9 maybe it goes back to Chapter 7 and 8 where 10 you really are using CHAD, but in my comments 11 in Chapter 8 I did talk about, it would be 12 nice to have a little more discussion of CHAD. 13 And then that sets up for this kind of

14 statement. 15 In Chapter 9, since I think it's 16 supposed to be a synthesis across the 17 document, one of the things that I think is 18 extremely important is to be consistent. And, 19 you know, you have some endpoints that are, 20 you know, short-term, city-based. You have 21 others that are long-term national-based, but 22 at least it would be nice to use the same202-234-4433 Neal R. Gross & Co., Inc. Page 110

1 statistics to summarize them. 2 So for example, you know, if you 3 report a mean estimate and a probability range 4 for each of these results, so that at least 5 it's consistent in that regard, because I find 6 it confusing when it goes between different 7 metrics. 8 And also, some estimates are 9 reported based on three years accumulated, 10 like for the national mortality estimates. 11 And others I think are annual. And that could 12 generate a lot of confusion, so I would just 13 encourage consistency. 14 I think in terms of being a kind 15 of a synthesis chapter, it would be important 16 to have not a long discussion, but at least a 17 discussion on what wasn't modeled, you know, 18 there are health endpoints that are identified 19 in the ISA that, you know, have some weight of 20 evidence that are not part of the risk 21 assessment. And I think it would be nice to 22 say so. Page 111

1 And likewise, what are the 2 limitations of what was modeled? This doesn't 3 have to be tables and tables of uncertainty 4 estimates but, you know, what are the top 5 three to five limitations? And what could be 6 said about biases in the quantitative 7 estimate, either because of limitations or 8 because of things that weren't modeled, you 9 know, is the true risk to the public 10 underestimated because the model only 11 addressed certain endpoints, or particular 12 endpoints?

13 And then I have some other 14 detailed comments. I think since Jon promised 15 we would talk more about background here, I'll 16 say something about that. 17 I've been listening carefully to 18 Fred's comments and to what Bryan had to say, 19 and I think, it seems to me that we have to be 20 a little careful not to presume what decision 21 the Administrator is going to make. 22 And I think, my understanding of Page 112

1 the statute of the Clean Air Act is that 2 there's nothing in it that specifically 3 addresses background. And it may be that this 4 just wasn't anticipated when the Clean Air Act 5 was written more than 40 years ago that, you 6 know, the criteria pollutants, at least 7 implicitly, are conceptualized as probably 8 having a threshold and probably we're looking 9 at concentrations well above background. This 10 statute works well if those conditions are

11 met. 12 And we're finding, well, with more 13 science, that well, maybe there isn't a 14 threshold or we can't find it yet. And 15 there's health effects at levels that go down 16 to background. I think that's a policy issue 17 for the Administrator to grapple with. 18 So I think from a science 19 perspective, I don't see anything wrong with 20 giving information to the Administrator, such 21 as Fred suggested that, well we ought to 22 estimate the risk associated with exposures up Page 113 1 to background relative to zero or, I think 2 relative to zero to me makes sense, or 3 relative to LML, and I'm not so sure. 4 That doesn't bother me to give 5 that as information but I think we also need 6 to give the Administrator information on the 7 risk from the level of the standard down to 8 either zero or LML, and so that the 9 Administrator has that information. 10 The Administrator can decide what 11 the policy options are for background, if any. 12 I think we're presuming there's no policy 13 option, maybe the administration comes up with 14 some creative international treaty or, you 15 know, unlikely, but I just don't think we 16 should prejudge that too much, so I just 17 wanted to throw that in. 18 CHAIR SAMET: Okay, thanks. And

19 Ted. 20 DR. RUSSELL: Yes, thank you, 21 Michelle and Chris have captured many of my 22 thoughts, just some other things, you know,202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 when you see something like 20 to 930 deaths, 2 that doesn't communicate much to me except 3 actually at first level it sounds like there's 4 quite a bit of uncertainty in the results.

5 So I'm not sure that that's 6 telling the story that you really want. And 7 I think it would be better if you came up with 8 a way of capturing the same idea, you know, I 9 was thinking maybe in a table and you specify 10 what the range is really all about. 11 You used the word, you know, 12 another little one and sort of getting back to 13 making sure what you say is what you really 14 mean when you said there is considerable 15 variation, when actually I looked at it and I 16 didn't see that much variation, this had to do 17 with the range in deaths between the two 18 studies. 19 And, you know, in terms of a 20 synthesis, I realize this is still a work in 21 progress. I didn't see that, you know, there 22 was some obvious areas for synthesis that you Page 115 1 could do between the various studies so far, 2 they're just not there yet. And I just assume 3 they're coming. So we'll see that on the next 4 review. Thank you. 5 CHAIR SAMET: Thanks, Ted. I 6 think just to elaborate on Ted's comment, I 7 mean, assuming that this is sort of a first 8 glimpse at what is to come, I mean, if the 9 plot is the synthesis, there is no synthesis, 10 there's not even a heading that says 11 synthesis, there's something that says 12 observations at the end. 13 So I think this is also where the 14 problems with Chapter 2 sort of come back at 15 you, because if you had that true framework 16 that is not there in Chapter 2 then you should 17 be coming back to it here, using that to 18 really frame consideration of what you found 19 with the exposure and risk assessment, and put 20 the whole story together. 21 And I recognize right now that 22 you're not there yet, you don't have all the Page 116 1 pieces together, you're sort of lining them 2 up. But you don't really have, you didn't 3 create the framework initially -- I know you 4 did, because you had to but you certainly have 5 not made it explicit. 6 So I think Chapter 2 should 7 provide the framework and Chapter 9 you come 8 back and say, well, turning to our framework, 9 here's what we found. And then truly have a 10 synthesis section that I think we all agree 11 will be there. So, yes, Howie. 12 DR. NEUFELD: I'd just make a 13 comment too about the clarity of writing, 14 trying to get your point across. I'm just 15 reading this one section here on Page 9-9, you 16 say five to 60 percent of mortality reductions 17 occur due to reductions in ozone on days when 18 ozone is greater than this value. 19 And then you say what would happen 20 after you meet the current standard, and you 21 say it falls to four to 59 percent. But 22 given, you know, error bars and things like Page 117 1 that, it really probably didn't change, right? 2 So, when one says "falls," I mean, 3 do you mean statistically significant, that 4 that one percent is a reduction, or really, is 5 that really just the same? So I think just be 6 careful about when you say something happens, 7 whether that's really statistically 8 significant or not. 9 CHAIR SAMET: Okay, other comments 10 on Chapter 9? David. 11 DR. CHOCK: If you look at Page 9- 12 4, there is an area talking about comparing 13 just meeting the current standard of Los 14 Angeles versus three other cities and claims 15 that children exposed above 0.6 ppm is 16 considerably less, and the range may be two to 17 five percent compared to other cities of 23 to 18 37 percent. And I think this is really an 19 artifact of quadratic rollback, because I 20 think that's a region where the suppression of 21 the concentration is excessive. And I hope 22 you look into that.202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 CHAIR SAMET: Okay, Fred. 2 DR. MILLER: I have just one 3 comment and that has to do with, on Page 9-11 4 you're talking about, in the next draft, 5 particularly for the case of short-term 6 exposure and mortality risk, you talk about 7 treating co-pollutants. 8 Personally, I don't want to see 9 any risk estimates that do not adjust for PM 10 because otherwise, to me, you're highly 11 double-counting. And so that, to me, should 12 be the baseline as the minimum, that 13 everything is included. And you didn't do it 14 in the first draft and you say you're going 15 to, you know, consider this. To me, adjusting 16 for PM in your analyses here is an absolute

17 must. 18 CHAIR SAMET: Okay. Yes, Helen. 19 DR. SUH: I guess my understanding 20 of this chapter was really that it wasn't 21 supposed to be a summary but really a 22 synthesis. And building on what Jon had said, Page 119 1 is it your intention for the second round to 2 also include the summary? 3 Because my guess is that lends to 4 some of the repetition that people, you know, 5 we've been mentioning. Because there's the 6 executive summary, there's a summary of 7 results in each of the chapters, and then 8 there's a summary again. 9 And so, I guess I would recommend 10 taking out that summary here and really having 11 it be a synthesis. And I think that would 12 help with some of the perceived repetition.

13 DR. HUBBELL: If I could ask a 14 question about that, because I think that's an 15 interesting point. And we struggled a bit 16 with that, that issue of repetition, you know, 17 and you'll see in the chapters we didn't quite 18 have the consistency that we would like in 19 terms of some of the chapters do a lot of 20 summarization at the end, some of the chapters 21 don't do any. 22 And we're trying to figure out the Page 120 1 correct way to balance this, and the intent of 2 Chapter 9, which was the new chapter just 3 because we looked at this and we said, well we 4 have, you know, exposure, clinical risk, 5 national risk estimates, and the urban case 6 studies, we really ought to have something 7 that synthesizes across. 8 It's actually, as the ISA people 9 are aware, it's a very difficult task to 10 synthesize. And so we're really exploring and 11 working on this so, you know, we're very 12 welcome to ideas as to what would make this 13 most useful and most informative. 14 And, you know, I think if taking 15 those summaries out and putting them in the 16 chapters themselves makes sense, that's fine. 17 If having a separate summary chapter makes 18 sense, we're willing to consider that as well, 19 or having a section of the synthesis that is 20 summary and synthesis would be fine too. 21 DR. SUH: Yes, I mean, I guess I 22 was thinking that it would be nice to have at Page 121 1 the end of each chapter the summary of the key 2 findings. I don't think every finding needs 3 to be in there, but just the key findings that 4 are going to get brought forward into other 5 chapters or even into the policy assessment. 6 And here, I guess I was thinking 7 that it would be more of a discussion like you 8 might, I mean, I know they're very, very hard 9 to write. A good synthesis is very difficult 10 but, you know, maybe akin to a discussion in 11 a research paper, that it really doesn't talk 12 about all the findings but it talks about the 13 major ones and the ones that have big 14 implications to what might be coming next. 15 And that's the kind of synthesis I 16 think would be so useful and it wouldn't copy 17 the executive summary so much, right, and it 18 would really put all those results from the 19 different chapters together to say, well how 20 do they all fit together to tell, you know, a 21 piece of this or many pieces of this story

22 that need to be told.202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 I think that would be extremely 2 effective. I know it's very difficult, but I 3 guess that's what I was thinking would be 4 really important for this. 5 CHAIR SAMET: Just to clarify, 6 there will be an executive summary? 7 DR. HUBBELL: Yes, the plan is to 8 have an executive summary for the second 9 draft. And again, the executive summary was 10 considered to be much more of an overview and 11 a more layman's discussion of the whole

12 document. 13 And the synthesis was intended to 14 be, as Helen said, very, much more about 15 integrating. We didn't accomplish that this 16 time but that's what we're hoping to do. 17 CHAIR SAMET: I mean, I certainly 18 want to reinforce what Helen said about having 19 a true integrative synthesis, it actually 20 implies that somebody has looked across the 21 whole document, understood it, understood how 22 it fits together and bought it together. And Page 123 1 I think that's probably sort of a critical 2 piece of your own internal peer review if 3 nothing else. 4 DR. HUBBELL: Yes, and one of the 5 reasons why we didn't, we had attempted to do 6 a little bit more but because we didn't have 7 the clinical risk information available and a 8 reasonable amount of time to redo this, that's 9 why it suffers from that. 10 But, you know, as one of the, as 11 the author of that particular chapter, it's 12 something that we really want to do, and we 13 want to make it something very, very useful 14 for you all to be able to review and 15 understand what we want to bring forward. 16 So it may take a few times to get 17 this right and we're really looking for, you 18 know, I'd love very strong criticisms of what 19 goes in and out of that would be very, very 20 helpful. 21 CHAIR SAMET: Okay, other comments 22 on Chapter 9? Let's see, Michelle, could you Page 124

1 do the -- 2 DR. BELL: I volunteered, Jon. 3 CHAIR SAMET: Oh, you did? Okay. 4 DR. FREY: I think Sverre should 5 do it.

6 DR. BELL: I volunteer Sverre. 7 (Laughter.) 8 CHAIR SAMET: So a general comment 9 that I want to make, in doing this assessment, 10 you draw on the old assessment. You draw on 11 the scientific foundations for that 12 assessment, you draw on what is in the ISA 13 that is relevant to refining the last

14 assessment. 15 You have this nice little diagram 16 with an arrow that goes from ISA to REA. But 17 it is certainly not explicit in the text or 18 the structure here. There's some commentary 19 up front, but to me, it would be very helpful 20 if at the start of each of the sort of 21 methodological sections you said, here is what 22 we are using from the last assessment, here is Page 125 1 how we have changed it, here is why we have 2 changed it based on the ISA, and did that 3 explicitly in each chapter because I think 4 that would bring a sharper reality to the 5 relationship between the two documents. 6 There's text like that imbedded in 7 there but it sort of comes in different spots 8 a little bit haphazardly. But I think it 9 would be very helpful and also clarify how you 10 ground this in the ISA. So here really, the 11 ISA serves you for supporting use of 12 particular pieces, concentration response 13 functions, whatever, you know, refinements to 14 exposure methodology, but just be explicit. 15 I think that would be very helpful in your 16 document. Any other comments on this

17 document? 18 DR. BRAIN: I like that idea and 19 one could imagine that such comments could be 20 bolded so they could easily be identified as 21 you move through the document, what's really 22 happened, what are the significant changes.202-234-4433 Neal R. Gross & Co., Inc. Page 126

1 CHAIR SAMET: So we are at a 2 point, I think we've finished this, unless 3 anybody has any last comments, I think we've 4 covered it well. 5 I think there's, Kathy's not here 6 yet, expected soon. And I also wonder, if 7 we're going to turn back to the discussion of 8 the PRB, whether we should wait until we go 9 through the welfare risk and exposure 10 assessment and have a more general discussion. 11 That seems to make sense, I think. So I think

12 there's -- 13 DR. HUBBELL: And Jon, we had one 14 clarifying point that Zach wanted to make 15 about one of the chapters if that's okay.

16 CHAIR SAMET: Sure. 17 DR. HUBBELL: Okay, go ahead. 18 DR. PEKAR: Okay. So just 19 yesterday, the public commenters, there were 20 two comments that were actually made that just 21 for the record, I wanted to clarify a little 22 bit. Page 127

1 It was stated that we didn't use 2 or include confidence intervals on the effect 3 estimates for the Bayesian adjusted, or 4 Bayesian shrunken estimates that we used for 5 short-term mortality, the Bell and the 6 Zanobetti and Schwartz, and that's not 7 factually correct. We did include those 8 conference intervals and did generate 95th 9 percentile confidence estimates. It was the 10 delta risk estimates that don't have those 11 confidence intervals at this point, but we're 12 going to update that. 13 And I think more importantly, and 14 I talked to Dr. Smith about this afterwards, 15 we actually, specifically, in the document 16 referenced his study, looking at the regional 17 Bayesian effect estimates and identify that as 18 an option for the follow-on work. So I just 19 wanted to be clear that we had referenced his 20 study and the option of looking at those 21 Bayesian adjusted priors. 22 CHAIR SAMET: Okay, thanks. All Page 128 1 right, one thing that we can do now and we're 2 going to sit down and have a small conference 3 here about what we're going to do next in 4 light of our schedule, is to take a look -- 5 you can put this up now, this is, I think the 6 list of things that you said you were going 7 to, that are still to be done. 8 DR. NUGENT: We're not centered, 9 Greg. I don't know whether that's something 10 you can help with, showing up on my screen as 11 centered but not up there. 12 CHAIR SAMET: Let's see. Actually, 13 Bryan or Lydia, do you want to take us through 14 this.

15 DR. HUBBELL: You want me to walk 16 you through that?

17 CHAIR SAMET: Yes. 18 DR. HUBBELL: Okay, all right. A 19 couple of broad notes on this is that we have 20 laid out by chapter the various different 21 items that we have identified as areas we are 22 considering or have committed ourselves to. Page 129 1 These are not prioritized across the different 2 chapters. We're obviously looking for your 3 input as to what are the items that you feel 4 are most important to address. 5 There's a couple of items, 6 including this first one which I put in based 7 on conversations yesterday because they made

8 clear sense to us that we'd want to make sure 9 we added them. Obviously, the ones that we've 10 discussed this morning are not added to the 11 list yet, but can be. 12 So the first one was Chapter 2, 13 and I heard a number of times that we need to 14 improve our conceptual framework chapter, 15 possibly by adding a broader conceptual 16 framework diagram and then more carefully 17 laying out the various different elements that 18 we expect to address with our risk modeling. 19 So that's something we expect to be able to

20 do. 21 Chapter 4, this was the Air 22 Quality Considerations. Most of these have to202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 do with the CMAQ-HDDM methodology and 2 implementing it. Again, we're continuing to 3 evaluate this methodology. And one thing I 4 wanted to make sure that we conveyed to you is 5 our interest in your comments not only on what 6 is in the main body of the document, but also 7 on the technical memo that describes the HDDM 8 approach that we are developing and how it's 9 specifically being proposed that we implement 10 it in the second draft. And this is the Simon 11 et al. memo which has been posted to the Web 12 site as well. 13 And we, again, especially for 14 those of you who are heavily involved in the 15 air quality modeling side of things, we would 16 really welcome your comments on the specific 17 method of implementing the HDDM approach. 18 An important factor as well within 19 the air quality is that we're planning to 20 update the base platform for the modeling of 21 2007. And that's an important update because 22 it's going to be using average fires rather Page 131 1 than the year-specific fires in that 2 particular modeling. 3 And then there was a number of, 4 I'm not going to go through these 5 specifically, but there's a number of 6 potential updates to the HDDM approach that we 7 think are appropriate for us to be 8 considering. 9 There is also an additional item 10 that we're not considering based on our 11 conversations yesterday and today. And that's 12 evaluating the feasibility of estimating 13 background ozone, both using the CMAQ-HDDM 14 modeling platform as well as looking at other 15 available models for background values. 16 That includes the GEOS-Chem and 17 CAMx modeling, as well as considering, and, 18 again, this is a really important 19 consideration and I'm hoping that the 20 discussion this afternoon will cover this, 21 which is, if a decision is made that, you 22 know, it's reasonable to look at at least one Page 132 1 definition of background ozone as a way of 2 apportioning risk, the question of what 3 definitions of background are most appropriate 4 for us to be considering. There are a number 5 of different ways to define background and I 6 think it's very important for us to get some 7 input on those definitions. 8 And again, one thing to remember 9 as well is in doing these background 10 estimates, they're heavily dependent on the 11 emissions inputs and the years of evaluation 12 as well. So there's a number of uncertainties 13 that get brought in and the ability to 14 characterize those uncertainties is important. 15 Chapters 5 and 6, again, one of 16 the most important things is that for the 17 exposure and clinical risk will be expanding 18 from four areas to 16 areas. The 16 areas is 19 different than the 12 areas for the Urban Case 20 Study Risk Estimates because those exposure 21 analyses can look at a broader range of cities 22 because they don't require information on Page 133

1 baseline incidence rates or concentration 2 response relationships. And that's the 3 determining factor for the risk, Urban Case 4 Study areas for the epidemiological risk 5 estimates. 6 We're also hoping to add exposure 7 estimates for outdoor workers and for older 8 populations. And we'll be looking at, again, 9 a number of different alternative standards 10 which we have not determined as the number or 11 the specific level yet. 12 Specific to Chapter 5, on the 13 exposure assessment there's a number of 14 different sensitivity analyses we're planning 15 on doing. We heard very loud and clear that 16 there's several that are very important to the 17 panel and we'll certainly take that into

18 account. 19 We are looking at evaluating the 20 representativeness of the CHAD activity 21 patterns as well as developing some potential 22 sensitivity analyses looking at different202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 years of the CHAD data or different specific 2 populations within that. 3 And another thing we're planning 4 on doing is looking at a different method for 5 spatial interpolation within those urban areas 6 for exposure, you know, the exposure 7 calculations use a much more refined set of 8 information on air quality both temporally and 9 spatially than the epidemiological studies, 10 which use these more aggregate measures of air 11 quality over the urban areas, so there's a 12 need to look at that a little more carefully. 13 And then this idea of looking at 14 repeated exposures, that would give me 15 longitudinal exposures where you have certain 16 individuals who may have sustained activity 17 patterns that can lead to higher exposures, we

18 wanted to look at that. 19 And just a clarification of the 20 types of uncertainty, we heard a good 21 suggestion about trying to classify those into 22 things we can address qualitatively through Page 135 1 sensitivity analyses or things where we don't 2 have enough data to make a determination. 3 On the Lung Function Risk 4 Assessment, again, this is an important issue 5 that we wanted to mention, is that some of the 6 changes we're proposing are conditional on the 7 availability of data from the study authors. 8 We're trying to update the two, 9 both types of lung function estimates with 10 data from additional clinical studies, and 11 we've been working to get the data from the 12 Kim et al. and Schelegle et al., but also 13 looking back at previous estimates from back 14 in the '80s and '90s and not all the data has 15 been able to -- we have not been able to get

16 all the data that we wanted to be able to look 17 at the full range of studies. 18 And then in terms of the McDonnell 19 Study, there has been an issue with being able 20 to obtain the underlying data that McDonnell 21 used to estimate those risk functions. And 22 we're trying to work with that, but some of Page 136 1 the data that McDonnell received, the 2 underlying study authors have not been willing 3 to share that data with EPA and so it becomes 4 a problem for us to be able to replicate the 5 results and be able to do uncertainty 6 assessments. So that's the thing we're trying 7 to deal with, but that has been a limitation 8 in implementing that model. 9 And then for Chapter 7, which is 10 Urban Area Case Studies for the 11 epidemiological risk, again we'll be looking 12 at just attaining alternative standards as 13 well as the current standard. We're going to 14 be adding assessment or evaluating the 15 addition of assessments for respiratory 16 mortality risk for long-term exposures, 17 including potential sensitivity analysis based 18 on using regional effect estimates. 19 We're going to be adding the 20 conference intervals for the risk reductions, 21 again, there's a couple different ways you can 22 do that, one is by comparing the risks at Page 137

1 current levels with the risks at the lowest 2 measured levels. There's also a process in 3 NMMAPS for just specifying the change in air 4 quality and estimating confidence intervals 5 based on that and we're working through those 6 details. 7 And then again, conditional on 8 availability of data from various different 9 study authors, we're considering adding a 10 number of sensitivity analyses for alternative 11 model specifications, some of the issues for 12 the multi-city studies is getting the Bayesian 13 adjusted estimates for different lags or other 14 things that allow us to make a comparative 15 analysis between our primary estimates and 16 these alternative specifications. There's a 17 bit of an apples to oranges if we don't have 18 the city-specific Bayesian shrunken estimates, 19 and that's been an issue. Okay, so that's

20 that one. 21 We're also looking at alternatives 22 to the way we construct the composite monitor,202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 you know, we have to make certain 2 simplifications to try to match the way the 3 monitors were dealt with in certain studies. 4 NMMAPS specifically uses a very complicated 5 structure for doing trimming of different 6 monitor data, et cetera. 7 And it's not clear to us if we did 8 the same trimming using current air quality, 9 whether that actually gives you the right 10 match to using -- to air quality that was 11 generated during the actual study period. So 12 there's some questions about how best to match

13 that data. 14 We're also planning on further 15 analyzing patterns of interest. Several of

16 the CASAC members have noted that there's some 17 very interesting differences between the 18 Zanobetti and Schwartz and Bell studies in 19 terms of the effect estimates and the 20 magnitude. 21 We like the idea of doing a 22 correlation between the studies both in terms Page 139 1 of the air quality data and in terms of the 2 effect estimates, and we'll be looking at some 3 of those comparisons and trying to better 4 understand why you see such heterogeneity in 5 the cities that's not just explained by 6 population data. 7 The issue of the LML values, it's 8 very tricky. We appreciate you not commenting 9 on the poorness of the surrogate that we used 10 in the first draft. We're planning on 11 improving that LML characterization either by 12 getting the data directly from the authors, 13 which would be preferred, or if that data's 14 not available, we're going to try to construct 15 LML values based on matching the AQS data, the 16 ozone monitoring data to the periods of the 17 study and determining the lowest measured 18 levels in those locations. 19 And then finally, we'll be looking 20 at some sensitivity analysis on interpolation 21 of missing ozone data in deriving our 22 composite monitor values. Page 140

1 For the national scale risk 2 estimates, we're going to be, similar to the3 urban case studies, we'll be adding the long4 term exposure respiratory mortality estimates. 5 We'll be correcting the error that was in the 6 maps for the May to September average, versus 7 the full year average. 8 To the extent we're able to get 9 estimates, we're going to try to apply the May 10 to September city-specific concentration 11 response factors from the Bell et al. study. 12 And again, conditional on the 13 availability of the NMMAPS LML values, we 14 wanted to try to apply the city-specific LML 15 values to generate the mortality estimates 16 across the national set of counties that are17 included, and then potentially also use city18 specific estimates for the Zanobetti and 19 Schwartz estimates as well. 20 And then the final part is in 21 Chapter 8, Assessment of Representativeness of 22 the Urban Case Study Areas, we are considering Page 141 1 using the American Time Use Survey data to 2 look at national representativeness of the 3 urban areas for time spent outdoors. 4 And the reason why we wanted to do 5 this is that it also helps us to be able to 6 identify issues related to exposure

7 measurement error because that's one of the 8 concerns is that, especially for comparing 9 L.A. and New York and Houston, there are 10 clearly differences going on in terms of the 11 relationship between personal exposures and 12 ambient concentrations. And that's an 13 uncaptured source of variability and 14 heterogeneity between the cities and we're 15 trying to look at that. So that's the list, 16 it's a big list. 17 CHAIR SAMET: Great, thanks. I 18 think this was a useful exercise that probably 19 brings terror to your hearts. But there's a 20 lot potentially to do. I mean, you have a very 21 long list and we haven't looked at the welfare 22 document yet.202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 So I wonder, you know, what we 2 might do is just go back through, I think 3 you've heard committee opinions along the way 4 about some of these items but perhaps if we 5 went back and at least, you know, were 6 dichotomous about this and said perhaps some 7 things really need to be done and some things 8 are, you know, the kinds of things you think 9 about if you happen to have time, that might

10 be useful. 11 So let me make a suggestion that 12 we go back through the list and as a group, 13 see if we can provide some, perhaps not 14 consensus guidance, but some general guidance. 15 I think we're in full agreement that we need 16 a better Chapter 2. So I think we can mark 17 that as high. And Fred? 18 DR. MILLER: Can I ask us, when we 19 do this, if EPA's able to provide the division 20 of labor that's involved because we might end 21 up saying, well, all of these, but they're all 22 to the same people or the same subcontractor Page 143

1 that would do the work of that. So it's not 2 clear that we shouldn't also integrate that in 3 our discussion or let them integrate that. 4 CHAIR SAMET: Well, or let them 5 integrate that. We can certainly, yes. 6 DR. HUBBELL: Well, we do have a 7 little bit of contract help on the exposure 8 modeling inputs but we don't have any for the 9 other parts. 10 DR. MILLER: All right, well 11 that's good to know. And I'm sorry to have -- 12 I did used to know you guys, if you're still 13 alive at the end of this. 14 CHAIR SAMET: Okay, so let's go, I 15 think we can probably have consensus that we 16 need a good Chapter 2? Yes, okay. So we can 17 mark that H, that means high. 18 All right, and then the air 19 quality considerations, and some of these 20 we've actually discussed along the way. So 21 why don't we run down these and just see if we 22 can give some guidance here, just go down the Page 144 1 list I think is probably the easiest way, so

2 1A? 3 DR. RUSSELL: If I might, excuse 4 me. You're pretty much committed to going to 5 the 2007, right? I mean, that's a done deal, 6 it shouldn't add any real time? 7 MS. WEGMAN: Right, no, we're 8 already using 2007 in this data, but I think 9 the update of the platform is a given. That's 10 something that's already planned and it's 11 already underway and it's already mostly done. 12 DR. RUSSELL: Then 1b, I'll just 13 sort of, unless people stop me, the longer 14 modeling period, I'm not sure, particularly 15 when we start talking about the welfare 16 document, why not move to a whole year? I 17 just don't see why not. And maybe you can 18 give some reasons why not. 19 MS. SIMON: I was going to make 20 the same point. 21 I think it's just a computing 22 resource issue, looking at, you know, what's Page 145 1 necessary. And then obviously, the HDDM model 2 runs take longer than a typical model run, and 3 we're planning to do several iterations at 4 different emissions levels, so I think that's 5 the main concern, is just computer resources 6 and time to complete the modeling and then 7 have adequate time to analyze the data once 8 we've completed the modeling. But we are 9 considering doing an entire year, especially 10 if the committee thinks that it's necessary. 11 MS. WEGMAN: And the only other 12 thing I wanted to mention, you brought up the 13 welfare and HDDM, but at this point in time I 14 don't know if we feel comfortable with using 15 HDDM for rolling back welfare. I think, what 16 we have been analyzing is using HDDM for urban 17 scale rollbacks, but a national scale rollback 18 is a little bit more challenging. 19 And I don't think at this point we 20 know exactly how we would do HDDM on a 21 national scale to make sure that changes in 22 one area are rippling through, through changes202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 in another area and then, you know, that those 2 are correlating with each other. So I will 3 probably talk about this more when we discuss 4 the welfare REA, but just keep that in mind. 5 DR. RUSSELL: Okay, I'm not sure 6 how it couldn't, but that, so we can talk 7 about that offline. 8 DR. HUBBELL: The other thing I 9 wanted to mention on that is there is a bit of 10 a tradeoff potentially as well in the sense 11 that, you know, we haven't begun starting to 12 evaluate, and again, this is another of the 13 issues we're looking at, but being able to 14 evaluate combinations of NOx and VOC, to the 15 extent we're able to work through a 16 methodology that's acceptable, those are 17 additional runs that would take time. And if 18 we weren't trying to run full year runs you 19 might be able to do more combinations. 20 So it's a very much a tradeoff in 21 terms of, you know, right now we're scheduled 22 for trying to get another complete draft by, Page 147 1 you know, the end of winter. And that just 2 doesn't leave us a huge amount of time to do

3 all the model runs.

4 CHAIR SAMET: Fred. 5 DR. MILLER: What is the value of, 6 in terms of the health endpoints, of going 7 beyond what's recognized in the area as the 8 ozone season? What does it add in terms of 9 the amount of work you have to do versus the 10 potential gain for having, you know, now four 11 months where, you know, the highest ozone 12 exposure level is at 20 or 30 parts per 13 billion and you're now adding up risks on this

14 nature and that. 15 So I'm trying to understand what 16 would be the value going away from your 17 strategy that you did relative to the health 18 basis where these and the EPI studies were 19 done during ozone seasons. So how are you -- 20 it doesn't seem like a lot of return for the 21 effort to go to the full year. But maybe 22 Sverre and some others can jump in here about Page 148 1 what's really -- 2 MS. SIMON: I think that one of 3 the issues is that in certain areas of the 4 country the ozone season is the full year. So 5 for instance, in L.A., we define the ozone 6 season as being year-round. 7 And so we're planning on doing one 8 national scale modeling run, so if we're 9 doing, you know, the nation for the year, it's 10 not like we would do a shorter period of time 11 for New York than L.A. because it's going to 12 be a national scale modeling. 13 DR. BRAIN: And clearly, the 14 control strategies are all year long, so in 15 fact, the Administrator might like to know 16 that applying these all year might have less 17 benefit in some of these non-ozone months in 18 some areas. But it seems to me it's important 19 information. 20 DR. BELL: Yes, I would say this 21 is, in my view, a high priority, resources and 22 time permitting. Because depending on your Page 149 1 threshold assumptions, there could be health 2 impacts during non-ozone season. 3 There's no such thing as an ozone 4 season that you're going to apply uniformly to 5 every city. And if you start applying 6 different months to different cities, then 7 it's getting difficult to interpret. So I 8 think, resources permitting, going year-round 9 would be fantastic. 10 DR. MILLER: Well, how do the 11 Bayesian estimates that you're going to use 12 for these city-specific things that were 13 derived, not using full year exposures and 14 seasonality, how are those going to be 15 adjusted to incorporate into this? Is this 16 something that's doable?

17 DR. BELL: Yes. 18 MS. SIMON: Just in response to 19 Michelle's comment, although you might want to 20 look at ozone throughout the year for a lot of 21 these areas where EPA has defined an ozone 22 season, they turn off the monitors during202-234-4433 Neal R. Gross & Co., Inc. Page 150 1 certain months so we're not going to 2 necessarily be able to evaluate the exposure 3 when there's no monitoring data. 4 DR. BELL: That's why I meant to 5 the degree possible. 6 MS. SIMON: Okay. 7 CHAIR SAMET: Okay, let's see, I 8 think Daniel. 9 DR. JACOB: You mentioned about 10 using average fire for this. What did you 11 mean by that? 12 MS. WESSON: So, in the 2007 run 13 that was fused for the national scale, the 14 2007 run actually had real fires in there so 15 you see all the Idaho fires very clearly. 16 So in general, when we run our 17 models, we have a average fire inventory that 18 goes in, which represents an average of fire 19 emissions over several years. And we are 20 recommending that we use that in the 2007 run 21 this time around so that when we fuse that 22 data with three years of ambient data, that Page 151 1 it's a little bit more apples and apples, 2 versus using the gradients from one model run 3 of 2007 with real fire data, paired with three 4 years of ambient data.

5 CHAIR SAMET: Other comments? 6 DR. JACOB: What theory rules do 7 you plan to use in the HDDM for in terms of 8 the sensitivity? 9 MS. SIMON: So what we've done in 10 our initial test cases, we've looked at first 11 and second order sensitivities to U.S. 12 anthropogenic NOx emissions nationwide, all 13 sources, and U.S. anthropogenic VOC emissions. 14 And I think Bryan can talk a little bit more 15 about why we chose not to differentiate source

16 sectors. 17 DR. JACOB: Yes, why not? 18 DR. HUBBELL: Well, the reason why 19 is that again, when we do these assessments, 20 what we're really trying to do is improve our 21 ability beyond the quadratic rollback method, 22 to reflect the responsiveness of the Page 152 1 atmosphere in these different urban areas to 2 changes in NOx and VOC, without specifically 3 getting into control strategies. 4 Control strategies is more of a 5 function of looking forward into the 6 implementation process. This is simply trying 7 to reflect, and really what we're trying to 8 find is some bounding cases that allowed us to 9 look at the potential for the atmosphere to 10 respond to just meeting the standard, without 11 trying to identify how we would actually get 12 there in terms of specifics. 13 So the reason why we looked at 14 domain wide, for example, rather than looking 15 at specific sources or specific locations, was 16 to be able to recognize that similar to what 17 we've done with the quadratic rollback, you're 18 trying to see what would happen if you just 19 attained in any specific area, without 20 assuming what other areas are going to do. 21 And so, when you look at domain 22 wide, you're simply saying, we're going to Page 153 1 identify how much, you know, when you reduce 2 NOx, NOx per se, all NOx, how much the air 3 quality responds in that particular location, 4 Atlanta or Detroit, and how it responds to

5 VOCs. And what we saw for Atlanta was that 6 VOCs didn't do much but for Detroit you could 7 look at either NOx or VOCs. 8 The limitation of what we've done 9 now is that we haven't been able to look at 10 combinations of NOx and VOC, which I think is 11 very important. And we haven't been able to 12 fully evaluate that yet. But that's, to me, 13 the next level that we really need to be able 14 to get to. 15 Now when we get to, you know, 16 thinking about individual sectors, then you 17 start asking the question: which sectors? And 18 there's any number of combinations you could 19 do. And it's not clear to me what value that 20 adds to the REA, certainly it's something

21 that's addressed when we look at control 22 strategies and things like the RIA. But202-234-4433 Neal R. Gross & Co., Inc. Page 154 1 that's a different beast all together. 2 So our focus was trying to say, 3 looking at individual locations, you know, 4 ignoring what's going on in other locations, 5 what is the responsiveness of the air quality 6 in that location, at different monitoring 7 within that location, to changes in NOx and 8 VOC, and that's really what we're trying to 9 accomplish. 10 DR. JACOB: So just to follow up, 11 it's the changes in national emissions of the 12 NOx and VOCs, right? 13 DR. HUBBELL: Right. 14 DR. JACOB: So you might then get 15 inconsistent results between different urban

16 areas? 17 DR. HUBBELL: Yes, and you would 18 get that with the quadratic rollback as well, 19 in fact, they're completely inconsistent 20 because they don't take into account how 21 changes in air quality in one location would 22 be reflected in changes in air quality in Page 155 1 another location. It's inherent in every type 2 of urban case study analysis that is looking 3 at just meeting the standard in each 4 individual location. 5 A national assessment would 6 require us to try to find an optimal level of 7 reductions across the country that would just 8 get every location into attainment. And 9 that's the reason why we don't do that for the 10 national scare assessment, is that it's very 11 difficult to simulate just meeting the 12 standard everywhere and not overattaining in 13 some locations and not others. 14 DR. JACOB: What are you going to 15 do outside of those 16 urban areas when you 16 have exceedance of those then, are you going 17 to be applying HDDM also? 18 DR. HUBBELL: We're not doing an 19 assessment of just meeting the standard 20 outside of those 16 areas. It's only in the 21 16 areas that we're looking at just meeting 22 the current standard and alternative Page 156

1 standards. 2 For the national scale assessment 3 it's only looking at current conditions. And 4 it's just purely to give a broader sense of 5 risk characterization, not to try to look at 6 the impacts of attaining alternative

7 standards. 8 DR. RUSSELL: I just need to talk 9 to him offline. 10 CHAIR SAMET: Okay. So let me 11 make a suggestion. Kathy is here, welcome. 12 So we're actually looking at this list of sort 13 of what to now is left for the Agency to do if 14 they bring the Health Risk Assessment, Health 15 Risk and Exposure Assessment to completion? 16 Let me suggest in terms of 17 schedule, that what we might try and do is go 18 through this a little more quickly than we are 19 doing, hint, and also perhaps before lunch, 20 hear the Agency presentation on the Welfare 21 Risk and Exposure Assessment Document. 22 So what I would suggest that we do Page 157 1 is, do try and progress through these, I think 2 if as just happened, important technical 3 thing, issues are surfaces, we should pause to 4 discuss them. But we've got a lot to get 5 through. 6 MS. WEGMAN: And did we get a 7 ranking, high, medium, low on this? 8 CHAIR SAMET: Well I think on this 9 one I heard high from some, if doable I think, 10 is that -- 11 DR. MILLER: On everything for 12 Chapter 4 or just what he talked about? 13 CHAIR SAMET: No, no, no, on no, I 14 think we were only at B, Fred, at the moment. 15 DR. MILLER: Oh, okay. 16 CHAIR SAMET: We may have wandered 17 into others but I think I heard most who 18 spoke, favor in going to the full year. And 19 we heard about the potential feasibility 20 constraints on that. Yes? 21 MS. SIMON: And I'd just like to 22 reiterate what Bryan mentioned previously,202-234-4433 Neal R. Gross & Co., Inc. Page 158 1 that we've heard a lot of generally positive 2 comments about using HDDM. But we'd also like 3 specific comments on our specific methodology 4 and implementation in the memo, the technical 5 memo that was presented, because I think there 6 was a comment yesterday about, you know, we're 7 not going to be able to necessarily predict 8 all of the committee's reactions to how this 9 is implemented. And so we have done a few 10 case studies where we've laid out a specific 11 methodology and -- 12 CHAIR SAMET: Okay, so we'll, we 13 need a note that we are certain to cover that. 14 So let's go to -- 15 DR. MILLER: Jon, was that only if 16 we went and downloaded it or was it sent to 17 us? Because I don't recall seeing this memo. 18 CHAIR SAMET: Download, so it's in 19 the materials on the Web site. 20 DR. MILLER: So you have to go and 21 download it? 22 DR. NUGENT: If you like, I can Page 159 1 send it to you.

2 DR. MILLER: Please do because 3 I'll go, it's another story, never mind. 4 CHAIR SAMET: Okay, all right, 1c, 5 making rapid progress under Chapter 4. So, 6 update to CMAQ v5 if available, et cetera. 7 DR. RUSSELL: Not a high priority. 8 CHAIR SAMET: Yes, I was going to 9 say this sounds like an L? 10 DR. RUSSELL: The coefficients 11 don't change between versions very much. 12 CHAIR SAMET: Okay, D, explore 13 other approaches for grouping model and 14 observe days in the bins? 15 DR. BRAIN: Sounds like a no.

16 CHAIR SAMET: Yes. 17 DR. BRAIN: It's something we can 18 propose, but again offline. And if they want 19 to do it, fine. 20 CHAIR SAMET: Okay, so expand the 21 16 cities, that's a must, that's a definite, 22 that's part of your plans. F, consider Page 160 1 expanding to two DV periods, we only analyzed,

2 at 2008-2010. 3 DR. HUBBELL: Yes, we have to do

4 that.

5 CHAIR SAMET: And then what about 6 G, comments there, combinations -- 7 DR. RUSSELL: I'm actually not 8 sure, I think this is something we don't, at 9 least I don't understand what the issue here 10 is. 11 DR. HUBBELL: Let me just explain 12 it real quickly. When we looked at Detroit, 13 for example, to get to attainment it was a 50 14 percent reduction in NOx, or a 70 -- 15 MS. SIMON: Eighty-five. 16 DR. HUBBELL: -- 85 percent 17 reduction in VOC. Clearly, the purpose of 18 using VOC emission reductions in a place like 19 Detroit is not to get to attainment all by 20 itself, it's to try to offset some of the NOx 21 disbenefits you might get in the core areas. 22 So combinations would tell you more about that Page 161 1 than looking at either just NOx or either just 2 VOC because it's not likely that VOC by itself 3 is going to be a dominant strategy. 4 DR. RUSSELL: I'm just, you've got 5 the sensitivity coefficients for each city, so 6 you've got the cross sensitivity and the 7 second order sensitivities, so this isn't even 8 part of recalculation using CMAQ. 9 MS. SIMON: Right. I think there 10 were two holdups about why we haven't used the 11 combination so far. One is that, to my 12 knowledge in the literature there has been a 13 fair amount of evaluation of, you know, 14 against brute force model runs with using NOx 15 or VOC alone, but I have not found any 16 evaluation in the literature where they've 17 evaluated the combination of NOx and VOC cuts 18 against brute force runs. And we would like -

19 - 20 DR. RUSSELL: The Hitomi reference

21 does that. 22 MS. SIMON: Okay. And we would202-234-4433 Neal R. Gross & Co., Inc. Page 162

1 also like to do that with our own runs before 2 we use the combination term. And the second 3 issue is just that when you get to doing 4 combinations of NOx and VOC cuts, there's, 5 could be potentially infinite combinations of, 6 you know, what percent NOx and what percent 7 VOC, so figuring out if there's some objective 8 way to kind of pick an optimal VOC to NOx, 9 cut, you know, if you're just doing NOx then 10 you don't have to make any of those decisions. 11 DR. MILLER: It's not clear to me, 12 is this for the national or for the 16 13 specific cities that you're talking about now? 14 MS. SIMON: This is for the urban 15 case studies, the 16. 16 DR. MILLER: Okay, is it possible 17 to not do it for all of them but, you know, 18 use your insight and show a couple of examples 19 of what the impact could be, because -- 20 DR. HUBBELL: Yes. I think that 21 is, in fact that may be the way we think about 22 it because for example, in Atlanta, we were Page 163 1 able to pretty quickly identify the VOC's not 2 going to be effective at all, and so why

3 bother? 4 DR. RUSSELL: And the Simon memo

5 starts -- 6 DR. HUBBELL: It starts down that 7 path and we just need to finish exploring it, 8 I think was the question. 9 CHAIR SAMET: Okay, Item 2 under 10 Chapter 4, evaluation of feasibility of 11 estimating background ozone, both using the 12 CMAQ-HDDM model configuration and other 13 available models, as well, so here we go. 14 DR. HUBBELL: We're opening the 15 door a little bit. 16 DR. JACOB: So here, I think the 17 idea is that you would like to have an 18 estimate of the background that's consistent 19 with your HDDM application. It makes sense 20 that the ISA should include the CMAQ results, 21 which so far doesn't, right? 22 MS. SIMON: Yes, I'm not aware of Page 164 1 any published CMAQ studies that have done, 2 like zero out U.S. emissions. 3 DR. JACOB: Yes, I was talking 4 with Joe Pinto offline yesterday and he was 5 saying that the CMAQ background results are 6 very consistent versus CAMx or GEOS-Chem, but

7 that would need to be documented. 8 DR. RUSSELL: And also, I mean at 9 the same time in the ISA you have to document 10 the use of HDDM, that you really haven't. 11 CHAIR SAMET: So where does this 12 sit, I mean that's, then alternative 13 definitions so how many, what do you have in 14 mind there? 15 DR. HUBBELL: If we're going to go 16 down this road, we're looking for some advice 17 on this, you know, again there's a number of 18 policy considerations that come into selecting 19 different alternative definitions. Doing more 20 than one, it's going to be somewhat 21 prohibitive in terms of just the amount of 22 extra effort to be able to do multiple risk Page 165 1 estimates for multiple backgrounds and so

2 forth. 3 Clearly the one that has the least 4 policy implication from a straight support 5 standpoint is to look at natural background, 6 you know, which would be allowing us to look 7 at the full range of risk that's associated 8 with anthropogenic emissions. And then the 9 question of whether they're controllable or 10 not is not brought up as much.

11 CHAIR SAMET: So let me make a 12 suggestion. I think we need to maybe come 13 back to this after we discuss the Welfare 14 Document. And I think we had said before that 15 we would sort of wait and do that. Let's just 16 hold on this. Then Chapter 5 and 6, we've 17 dealt with urban areas, exposure estimates for 18 outdoor workers and people greater than 65, 19 you are doing, I think? Yes, Howie. 20 DR. NEUFELD: Just ask for a point 21 of clarification, you focus on these urban 22 areas, but is there any consideration in this202-234-4433 Neal R. Gross & Co., Inc. Page 166 1 talking about people in the rural areas? I 2 mean, what's the emphasis there? 3 DR. HUBBELL: Well, I mean, the 4 emphasis is two things, one is you're trying 5 to get to where you have a large population 6 center to get an idea of the general magnitude 7 of the exposures. 8 The second part is that we tried 9 to look at places that were at or above the

10 current standard. And those tended to be more 11 in the urban locations. 12 DR. NEUFELD: But there is some 13 evidence that people in some rural areas, the 14 ozone's actually higher than the urban areas. 15 DR. HUBBELL: Well, and actually 16 let me just point out one thing on that is 17 that, because I'm not sure if we've made this 18 clear, is that the definitions of the urban 19 areas, the extent of the urban areas that are 20 considered, differ between the exposure and 21 the epidemiological risk analyses because the 22 exposure assessment takes into account the Page 167 1 fact that people commute and travel, so it 2 does bring in areas that are contributing to 3 exposure within the overall urban areas. It's 4 not picking up rural areas necessarily, 5 they're just picking up suburban areas to a 6 certain extent. And I don't know, Jonathan, 7 you want to talk about the rural areas at all? 8 Yes, we had to prioritize and we 9 felt that that was, the priority was to get 10 the areas that would likely experience the 11 highest elevated ozone. Again, if you have 12 specific areas that you can identify for us 13 that you're concerned about, we can certainly 14 take that into consideration. 15 DR. MILLER: Didn't you, in either 16 the national or, I mean, one of these chapters 17 I've read, you indicated the percentage of the 18 U.S. population captured in your 16 cites, and 19 it seemed like it was extremely large 20 percentage of the total U.S. population.

21 DR. HUBBELL: I don't know whether 22 we had that or not, certainly I think we had Page 168 1 that in the national assessment, I don't think 2 it -- 3 DR. MILLER: I know I read it

4 somewhere. 5 DR. HUBBELL: Yes, it may have 6 been in the national, I don't remember where 7 we had that for our 16, but we can certainly 8 provide that. 9 DR. MILLER: Well I was just 10 wondering, you know, to kind of put it into 11 perspective of what's the extent of gain, I 12 thought it covered like 75 or 80 percent of 13 the total population. 14 DR. HUBBELL: I'm not sure, but 15 we'll find that out. 16 CHAIR SAMET: Okay, so let's go 17 back, so if I was to understand correctly, 18 let's go to Chapter 5, Exposure Assessment. 19 I think the things you have, these big items 20 under Chapters 5 and 6 are things you're 21 attending to. 22 DR. HUBBELL: Yes, that's to do. Page 169 1 MR. AVOL: So I have one question, 2 Jon, back on, just scroll back up, that 3 previous comment on the addition of exposure 4 estimates for outdoor workers and people 65- 5 years-old, so I just went back to the Chapter 6 2 framework and looked at at-risk populations, 7 and it lists four at-risk populations. It 8 lists children, outdoor workers, people over 9 65, and people of low socio-economic status. 10 Where does that fall in here? 11 DR. HUBBELL: John, do you want to 12 comment on this? 13 MR. LANGSTAFF: Well, we are going 14 to be doing an analysis of the lower, the 15 difference in SES and how that impacts, you 16 know, exposure and risk. 17 MS. WEGMAN: But that's going to

18 be - 19 MR. LANGSTAFF: Well, and that's 20 actually an analysis for dealing with high 21 risk groups.

22 DR. HUBBELL: We're not202-234-4433 Neal R. Gross & Co., Inc. Page 170 1 specifically estimating separate exposures for 2 low SES, but what we are doing is identifying, 3 in the populations that are higher risk, what 4 is the SES status of those individuals in the 5 high risk groups. And it's not quite the same 6 thing but it is a way of addressing it. 7 DR. SUH: I think just, Ed, I 8 don't think it's possible to use a population 9 exposure assessment using APEX for people with 10 low SES, it's just the activity data is not 11 there. And so I think it would be very 12 difficult in this circumstance to do that. 13 MR. AVOL: Right, I'm just saying 14 that there's sort of a logical inconsistency 15 in identifying it but then not -- 16 DR. SUH: But there is, I think it 17 was mentioned in the sensitivity analysis that 18 you guys are going to do. 19 DR. HUBBELL: Right, I mean we do 20 have the data there to do it from the census. 21 We're using trackable data that has SES 22 information. Page 171

1 MR. AVOL: Does the activity 2 barriers, do they contain SES information? 3 DR. HUBBELL: No they don't. 4 DR. MILLER: Yes, so that's the, 5 you wouldn't be able to have specific 6 activities that might get the buy in to this 7 category. 8 DR. SUH: I guess it would just be 9 important to bring that out. 10 CHAIR SAMET: Okay, on to Chapter 11 5 Number 1, which was Your Underexposure 12 Assessment I think this was improve the depth 13 and clarity of documentation presentation, 14 yes. 15 DR. SUH: Wait, wait, why was that

16 low?

17 CHAIR SAMET: What? 18 DR. SUH: I'm sorry, why was the

19 outdoor workers and the -- 20 CHAIR SAMET: No, outdoor workers 21 no, they weren't low.

22 DR. SUH: And that wasn't low. Page 172 1 CHAIR SAMET: No, this is all 2 high, no. It was, I think the discussion 3 around SESs where you, perhaps got confused. 4 DR. SUH: I don't even, I don't 5 think that's low I just think it's not, yes -- 6 CHAIR SAMET: Yes, it's all -- You 7 can leave all those, the general ones under 5 8 and 6 are all -- And certainly you are going 9 to do, what is it, Number 1 and Number 2, 10 which is, these workers, these are among our 11 key suggestions for the document. Now the 12 sensitivity analysis -- 13 DR. SUH: Well, that's high. 14 CHAIR SAMET: Let's see, I guess 15 the question is are all of these high? So for 16 example, considering developing a method for 17 spatial interpolations. 18 DR. RUSSELL: I think that one is

19 low. 20 DR. SUH: Yes, that one I think is

21 low. 22 DR. RUSSELL: Because, I mean, Page 173

1 we've done it and it doesn't make that much 2 difference. 3 CHAIR SAMET: Yes, so that one 4 would be low. The CHAD activity is a yes, 5 that's a high. What about evaluations for 6 above, what do you mean by 3a? I'm confused 7 at this point. 8 DR. HUBBELL: 3a was looking at if 9 we are to generate an alternative set of 10 background concentrations, that's something 11 that we would need to incorporate into the 12 greater risk influence as well. 13 CHAIR SAMET: I see, okay. So 14 potentially high. 15 DR. HUBBELL: Yes, that's 16 conditional. 17 CHAIR SAMET: And D, what do you 18 intend there?

19 MR. LANGSTAFF: Well there's 20 published studies such as Fred referred to 21 that we can compare the APEX similar results. 22 CHAIR SAMET: So this would be202-234-4433 Neal R. Gross & Co., Inc. Page 174 1 updating, so this would be a potential 2 updating expansion of the database on activity

3 levels or -- 4 MR. LANGSTAFF: No, this would be 5 comparing what APEX predicts to measure, you 6 know, studies that have done measurements and 7 just -- 8 DR. SUH: They model performance 9 validation. 10 MR. LANGSTAFF: Yes, evaluating 11 APEX essentially. 12 CHAIR SAMET: So this would be a 13 model validation, what's coming out of APEX 14 versus whatever estimates you can find. 15 MR. LANGSTAFF: Right. 16 DR. SUH: I'd say that's very 17 important. 18 DR. MILLER: Yes, I think it's in 19 the same category as I said about this double 20 water labeling and checking relative to the 21 CHAD in the percentile. So it's in that kind 22 of, how well does the model reflect what other Page 175 1 data sources may indicate might be going on -- 2 CHAIR SAMET: Okay so it's perhaps 3 poorly described here, that's, okay. 4 DR. HUBBELL: And I was going to, 5 Dr. Miller, if you could provide that 6 reference to that study that you mentioned 7 from Montreal, that would be great. 8 DR. MILLER: I'll wait until 9 tonight and then I can access the internet 10 because, you know, you people that aren't Mac 11 users if you, you have to set up a special 12 account and not go through your original 13 server. So I can't, I can get everything from 14 you but I can't send. 15 CHAIR SAMET: We feel for you, 16 Fred. Repeated exposures, repeated exposures, 17 that's for, analysis of repeated exposure for 18 cohorts of school children. 19 DR. SUH: It's high. I mean, I 20 guess we all mentioned them so I don't know, 21 I mean, I guess I'm just not sure how you're 22 going to do it but -- Page 176 1 CHAIR SAMET: Yes, it sounds 2 ambitious in terms of -- 3 DR. HUBBELL: Well, one of the 4 things we've discussed and then John can 5 elaborate, one of the things we've discussed 6 is creating scenarios, so we'd not simply be 7 doing a random draws in a way that repeats, it 8 would be simply saying, if there were a school 9 child who had the following activity pattern 10 repeated, what would the exposure be? Again, 11 it's difficult to know how representative that 12 child would be but it's a scenario. 13 DR. SUH: Well you could argue 14 that if they're at camp or in their school, 15 there is a pattern to their activities. 16 DR. HUBBELL: Yes, that's correct. 17 CHAIR SAMET: Okay. And then 18 obviously, additional clarification types of 19 uncertainty characterizations, sure.

20 DR. HUBBELL: Well that's 21 directly, I think, in response to what you 22 guys were asking about so. Page 177

1 CHAIR SAMET: All right, so on to 2 Chapter 6 -- 3 DR. MILLER: Wait, whoa, whoa, 4 before you go on, I thought that you couldn't 5 identify individuals with repeated occurrence

6 of attack.

7 DR. HUBBELL: Of -- 8 DR. MILLER: Well like in your 9 asthma, when they go back into the pool, you 10 can't tell that it's the same individual that 11 you're getting, that they can have more than

12 one. 13 DR. HUBBELL: Yes, this is purely 14 on the exposure side -- 15 DR. MILLER: Okay. 16 DR. HUBBELL: -- simply saying, 17 you know, what are the exposures for people 18 who are engaged in repeated activities or 19 locations that have higher ozone exposures? 20 Because right now the way that the diaries 21 work, the diary selection process works, you 22 don't get those connected strings of high202-234-4433 Neal R. Gross & Co., Inc. Page 178 1 activity levels. 2 DR. MILLER: Oh, okay. 3 DR. HUBBELL: And so this is just 4 trying to account for the fact that people

5 have -- 6 CHAIR SAMET: Thank you. Okay, so 7 6.1, I think we heard at least one suggestion 8 from Fred that this might be a lower priority? 9 That there was already a robust body of data, 10 this is on adding additional clinical studies. 11 DR. MILLER: Which one were you 12 talking about? 13 CHAIR SAMET: 6.1, Fred, Chapter 14 6, the first one. 15 DR. MILLER: Yes, it's a high 16 priority -- 17 CHAIR SAMET: You want that, I 18 thought you had said before that you were not 19 so sure that was necessary given the -- 20 DR. MILLER: No, I said that you 21 don't have to repeat the analysis from the 22 previous, that didn't include this, but if you Page 179 1 use the later models you want to include the

2 data. 3 And that raises the question that 4 you brought up about the availability of 5 McDonnell and some of the data not, I thought 6 if it was federally funded people had to give 7 you the data. So I'm surprised that, and I 8 know it's not, anyway, I'm surprised that 9 you're having trouble getting all of the data 10 that was used in that. 11 MR. LANGSTAFF: For this first 12 one, we already have the data from Kim and 13 Schelegle, so we can do that. And with the 14 other data, Adams is reluctant to give us his 15 data, so that's a huge part of the data set 16 that's used to fit the McDonnell, Stewart and 17 Smith model. 18 DR. MILLER: Why do you call it 19 huge? It pales in comparison to the 59 20 subjects that EPA did.

21 MR. LANGSTAFF: Well there's 22 several studies that he did back in the '80s Page 180 1 and '90s I guess that make up a pretty 2 significant part of that. 3 DR. MILLER: Okay. 4 MR. LANGSTAFF: And we can go

5 ahead and -- 6 DR. MILLER: But if McDonnell in 7 his paper shows that he's able to simulate 8 every exposure pattern that's been done, why 9 do you have to have the data from, and not 10 just use the output parameters of the final 11 McDonnell model? Why do you have to go back

12 to the raw database? 13 MR. LANGSTAFF: Well, we need to 14 have the data to look at the uncertainty of 15 the model. But perhaps we can do that with 16 just the data we have --

17 DR. MILLER: I see. 18 MR. LANGSTAFF: -- it's just not 19 going to be quite as good analysis of 20 uncertainty. 21 DR. MILLER: Yes, okay. Mr. 22 Adams, Dr. Adams, hmm. Page 181

1 CHAIR SAMET: Okay, so are both of 2 these then judged high? Is that -- 3 DR. KLEEBERGER: Jon, I think 4 there was also some discussion maybe that 5 falls into these two points about the 6 comparison of the McDonnell model with the 7 exposure function model, the differences in 8 the predictivities of those, I think you wrote 9 that up in the, you wrote in the document that 10 you were going to follow up and try to find

11 where -- 12 DR. HUBBELL: Right, yes. 13 DR. KLEEBERGER: -- what explains 14 those differences. 15 DR. HUBBELL: We're going to, yes. 16 DR. KLEEBERGER: Okay. 17 CHAIR SAMET: You know, we may 18 make, on this data sharing issue, we may want 19 to make a general comment. I mean, I think 20 these are important databases, these studies 21 are not going to be necessarily replicated in

22 the future.202-234-4433 Neal R. Gross & Co., Inc. Page 182 1 And even just the issue of 2 somebody curating them so that they're 3 available and archived is, to me, important. 4 And perhaps, you know, when we write our 5 general comments we should make a comment 6 about the importance in general of access to 7 key data sets. 8 And I think that comment should go 9 in somewhere, I mean, you know, I think 10 certainly the community sense around data 11 sharing has shifted a lot in the last decade. 12 And I think this is an example where having 13 the data set at the individual level would 14 allow analyses that might be a benefit in many 15 ways. Jim? 16 DR. ULTMAN: And I just thought of 17 a point of clarification in terms of which 18 version -- with the threshold -- 19 DR. NUGENT: Excuse me, Jim, could 20 you use the mic please? 21 DR. ULTMAN: Oh I'm sorry, I 22 apologize. Which version of the model of Page 183 1 McDonnell's are you planning to use, the one 2 with the threshold, the one without the 3 threshold, or are you going to compare them? 4 It seems like there's a lot of work that 5 you've got cut out for you there. 6 MR. LANGSTAFF: Well, we're 7 planning to use the model with the threshold. 8 We'll do some uncertainty analysis. It would 9 be a better analysis if we had all the data. 10 But it will be more limited without it but 11 that's the model we're planning on using. 12 DR. ULTMAN: Yes, you know, I read 13 and reread the McDonnell paper and it seems 14 like the difference in the fits to the model 15 is relatively modest between that. 16 MR. LANGSTAFF: Yes, right. 17 DR. ULTMAN: I mean, I wouldn't, 18 in fact I would be very careful not to push 19 the word threshold to the point that it looks 20 like that the paper has uncovered some kind of 21 a physiologic or biologic mechanism, because 22 it's really a model-based kind of a threshold. Page 184 1 Maybe you can come up with a different word 2 for it. 3 MR. LANGSTAFF: Yes, so it's a 4 dose threshold anyway, not a concentration 5 threshold, and yes, he says there's not much 6 difference between the two models. 7 DR. ULTMAN: Right. 8 CHAIR SAMET: Okay, on to Chapter

9 7 --

10 DR. NUGENT: So both of these are 11 high, is that correct? 12 CHAIR SAMET: They're high, yes. 13 And then Chapter 7.1, I think that's -- 14 DR. HUBBELL: Yes, that's a -- 15 CHAIR SAMET: That's a high. 16 DR. HUBBELL: That's a high, yes. 17 CHAIR SAMET: Now I think there 18 was some sense about 2 that, okay what about

19 2? 20 DR. VEDAL: Well, I don't think 21 there's any disagreement on mortality.

22 CHAIR SAMET: It was the Page 185

1 morbidity, that's correct. 2 DR. VEDAL: Right. 3 CHAIR SAMET: Okay. So that gets 4 an H. Confidence intervals you have, 5 apparently, these were going in. 4, this 6 potentially entails a lot of work. I mean I 7 guess I'd say this is something that would be 8 nice but, I don't know, others, Michelle, what 9 do you think? 10 DR. BELL: I agree with you. 11 CHAIR SAMET: Would it make you 12 happy if we put an L by this? 13 DR. MILLER: I kind of say, how 14 can you use data in which they haven't 15 adjusted for other co-pollutants and we're 16 talking in particular the importance of PM? 17 DR. BELL: Because, my view is 18 because there has been a wealth of evidence 19 showing that the ozone estimates are not 20 confounded by particles including specific 21 chemical components of particles. Therefore, 22 even an ozone estimate that doesn't adjust for202-234-4433 Neal R. Gross & Co., Inc. Page 186 1 particles we could say was quite unlikely to 2 be confounded by PM, given, I mean there's 3 been numerous studies that have looked at that 4 adjustment. But, I agree that if what I just 5 said is EPA's thinking, they could put that in

6 the document. 7 DR. HUBBELL: Yes, we'll do a 8 better job explaining that. And the other 9 issue that comes up, Fred, with this is that, 10 you know, for the large multi-city studies 11 you're dealing with PM data that's not 12 collected on an everyday basis and you have 13 ozone data that's collected on an everyday 14 basis and you lose statistical power when you 15 have to combine those two data sets. And so 16 while this is useful for sensitivity, it very17 much limits your ability to use large multi18 city studies.

19 DR. MILLER: And I understand that 20 and I understand what Michelle is bringing up. 21 However, in those studies, when they did 22 include them, they did change the size of the Page 187 1 effect estimate. They didn't change the

2 overall trends.

3 DR. VEDAL: I mean there are 4 complexities here, Fred. One complexity is it 5 tends a little bit on the endpoint as to6 whether there's going to be confounding by co7 pollutants. But the other issue is multi8 pollutant models and single-pollutant models, 9 the issues are complex. There's the issue of, 10 you know, differential measurement error by 11 pollutants and the impact of that on the 12 respective estimates. 13 So I'm not sure there's any 14 consensus that estimates for multi-pollutant 15 models are actually more valid than estimates 16 from single-pollutant models. Clearly, I mean 17 in both scenarios, there are uncertainties. 18 You'd like to split the difference but, you 19 know, that's a lot of work. 20 CHAIR SAMET: So of the items 21 listed here, for example lag structure, I mean 22 perhaps if one is to be given higher priority Page 188

1 because in the sense it's intuitive to raise 2 it, it is the question of is there sensitivity 3 to inclusion at least to PM in the models? 4 You do have, I mean putting aside 5 all the complexities that evolve around those 6 comparisons, restrictions, and data sets and 7 so on, there are data sets that would allow 8 you to provide some information on that, and 9 it's probably reasonable to do this. 10 I mean, I would worry about you 11 getting sunk in things like lag structure, 12 different outcomes, and different models. I 13 mean, I think that really could become 14 overwhelming quickly. 15 But I think perhaps of those 16 factors that you listed for the sensitivity 17 analysis, perhaps co-pollutants might receive 18 the greatest emphasis with higher priority.

19 DR. PEKAR: Just to make sure I'm 20 clear on that, so the regional prior 21 adjustment, that was the other thing that was 22 mentioned yesterday by Dr. Smith. And I just Page 189 1 wanted to be explicit about asking in regards 2 to that also, in the Bayesian adjusted effect 3 estimates. 4 DR. MILLER: I endorse it in my 5 written comments that you're going to get. 6 CHAIR SAMET: Michelle, do you

7 want to comment on that? 8 DR. BELL: I wasn't planning to. 9 CHAIR SAMET: Okay, frankly I'd be 10 surprised if it made much difference, might be 11 surprised if it made much difference but 12 that's, you can take a look. 13 DR. HUBBELL: One other question 14 for you is, as you know, there's a literature 15 on each of these elements. One question is, 16 do you think it's appropriate to focus on 17 maybe one or two cities where there may be, 18 you know, a study that has looked at these 19 things? 20 And we may not even need to take 21 it all the way through to the risk estimates 22 as much as just comparing the coefficients202-234-4433 Neal R. Gross & Co., Inc. Page 190 1 from the, you know, the effect estimates 2 across there and saying look, there's a 3 significant difference in the effect 4 estimates. Once you've applied it through the 5 concentration response functions, it's 6 probably going to have an equivalent impact 7 within a particular city. 8 Some of these, like the regional 9 functions, will obviously make a difference 10 between cities, but for some of the other ones 11 it might be, maybe it would be sufficient 12 simply to point to the literature and talk 13 about the difference. 14 CHAIR SAMET: I think to the 15 extent that you can do that, that would be -- 16 DR. HUBBELL: Helpful.

17 CHAIR SAMET: -- valuable. 18 DR. HUBBELL: Okay. 19 CHAIR SAMET: So let's go on. So 20 we're at 7.5, composite monitor of constructs. 21 DR. SUH: I think that there is 22 research showing that it doesn't matter so Page 191 1 much about how you average, more in the 2 process data.

3 DR. PEKAR: I'm not aware of those 4 studies. If you have a reference that would 5 be great. 6 CHAIR SAMET: So here you're 7 referring to things like the NMMAPS trimming

8 and so on?

9 DR. HUBBELL: Yes. 10 DR. BELL: I would personally put 11 this as it would be great if you could do it 12 but a low priority compared to other items 13 would be my assessment. 14 DR. SUH: Yes, and I also think 15 there's some citations you could probably use 16 to bolster what you do, so I think it's 17 probably, I would agree with Michelle. 18 DR. PEKAR: I mean, if you could 19 point us in that direction that would be 20 great. And that does save us a lot of work, 21 just to be clear, it does. 22 CHAIR SAMET: Number 6, addition Page 192 1 of further analysis of patterns of interest in 2 risk assessment? 3 DR. VEDAL: That would be, you 4 know, it's a small bit of work, relatively 5 minor. But it would be kind of neat if you

6 had that. 7 DR. HUBBELL: I think we're going

8 to do that I mean that's -- 9 DR. VEDAL: Yes, I think you will. 10 DR. HUBBELL: -- in order to be 11 able to do the synthesis we're going to have 12 to really get a better understanding of that. 13 CHAIR SAMET: Okay, LML, that's 7. 14 DR. VEDAL: Yes, LML, so this is a 15 big discussion that some way, because it's a 16 lot of work, you know, the whole exposition 17 regarding surrogates and all that, you know, 18 is all dependent on whether you're going to do 19 LML in the final analysis. 20 And, you know, I don't know, it's 21 a little bit of a tough call. I think it all 22 hinges on whether you think you're going to be Page 193 1 susceptible to criticism going beyond the 2 limits of the data. And you might be. 3 I personally am not bothered by it 4 and I'd prefer rather just to see going down 5 to background which, or going down to zero 6 which, you know, essentially gives you a 7 flavor of what is actually there and the 8 distribution of concentrations. But I'd like 9 to hear some other views, you know, on that. 10 CHAIR SAMET: And might this be 11 done in some illustrative locations and then 12 stop perhaps? I mean, I - 13 DR. HUBBELL: Well, one thing I'll 14 not on that and Zach can back me up on this, 15 but we were surprised at the amount of 16 variability in the LML values between 17 locations. For example, in New York City we 18 were looking at, it was almost close to zero. 19 And if it turns out that if you 20 think about the way daily values of ozone are, 21 if it's raining on a particular day for 22 example, you can have ozone concentrations202-234-4433 Neal R. Gross & Co., Inc. Page 194 1 very close to zero. 2 And, you know, for eight hour 3 metrics averaged over a city, you know, you 4 can get a huge amount of variability. And 5 it's not clear, again, one of the problems 6 with LML is it's the bottom of the data. It 7 doesn't tell you very much about data density 8 along the estimation of the concentration 9 response relationships. 10 So that's one of the reasons why 11 in the charge question we asked about are 12 there other places we should be looking? You 13 know, what Dr. Miller said earlier about, you 14 know, the fact that we want to know about the 15 confidence in the concentration response 16 relationship. 17 And sometimes, in previous 18 discussions, I think the discussion of 19 background and the discussion of confidence in 20 the C-R function get conflated. And we're 21 trying to separate those out a bit and get a 22 better understanding of how do we characterize Page 195 1 confidence in the relationship while still 2 providing the full range of information across

3 the board.

4 CHAIR SAMET: So how much work 5 would it be, Bryan, to do what you have in the 6 paren?

7 DR. HUBBELL: And what was the 8 parentheses -- 9 (Off microphone discussion) 10 DR. HUBBELL: Ben, how much 11 difficulty is there in constructing the lowest 12 values observed across a particular time 13 period and a location? 14 MR. WELLS: You've got to match to 15 the specific studies. 16 DR. HUBBELL: You've got to come 17 up here. Hold on, you've got to come up to a 18 mic. 19 MR. WELLS: This is Ben Wells. 20 DR. HUBBELL: He's our air quality 21 expert. 22 MR. WELLS: If I was able to get a Page 196 1 list of the epidemiological studies in the 2 study periods and the months used in those 3 periods then it wouldn't be too much 4 difficulty to match the ozone data to those 5 periods and to, you know, determine the lowest

6 measured levels. We have all of the ozone 7 data. It's just a matter of matching it to 8 the health studies. 9 CHAIR SAMET: Fred, aren't those 10 kinds of things in their publications?

11 MR. WELLS: No. 12 DR. MILLER: No, no. 13 DR. PEKAR: No, not that kind of 14 detail. 15 CHAIR SAMET: They don't say, 16 okay, I'm surprised. So they don't say we 17 sampled years 2010 to -- 18 DR. PEKAR: Oh, that is there but 19 not the detail of the LML. 20 DR. MILLER: Right, but the 21 specific LMLs are not listed for every 22 location within the statute. Page 197

1 MR. WELLS: And just to be clear, 2 this is not the lowest value at a monitor in 3 urban area, it's the constructed composite 4 values used in the statistical analysis. 5 DR. HUBBELL: Yes, and so again, 6 while we can create this construct that would 7 be based on previous air quality data, the 8 ability to specifically match the actual LML 9 that might have been used in the study itself, 10 the study design, is not something we can do. 11 CHAIR SAMET: Right, because of 12 the construct, right. So I don't know how 13 others feel, Chris? 14 DR. FREY: Well, just some 15 thoughts, you know, the comparison of the 16 results with and without the LML, I mean to me 17 as an engineer, I didn't see that much 18 difference in the risk estimates. So I didn't

19 know that there was that much value added. 20 I could see the point, you know, 21 that Sverre alludes to that you're less likely 22 to, or you're more robust to criticism if you202-234-4433 Neal R. Gross & Co., Inc. Page 198 1 take it into account. But it just seems like 2 at the margin it doesn't add a lot of value to

3 the results. 4 And I do think it is valuable to 5 do the risk, at least one set of risk 6 estimates should be relative to zero. But 7 ultimately, I think the policy analysis is 8 going to hinge probably more on how the risk 9 estimates compare among different non-zero 10 concentrations. 11 So I think the risk estimate down 12 to zero is kind of like background information 13 for the administrator. And in that sense, 14 maybe it doesn't need the same level of 15 quality as some of the comparative estimates 16 among different alternatives versus 17 background, for example. 18 And I guess, so I would think, 19 maybe as some alluded to, the thing is to pick 20 a few strategic cases and do a sensitivity for 21 those. But I think the work is not just to 22 figure out what is the composite LML, but it's Page 199

1 then to do the risk assessment. 2 So it's a little bit more than I 3 think, the answer that we just heard. And I 4 would rather use that time for something maybe 5 more important. 6 But if there were two or three 7 cities where the LML was, maybe some high 8 LMLs, if there are any that are above ten for 9 example, maybe look at those. And then just 10 say, you know, for LMLs below X, five or ten 11 that it's not going to affect the result more 12 than some percentage and we didn't look at it. 13 CHAIR SAMET: So I think that's an

14 L. 15 DR. PEKAR: I think that's a good 16 point and another thing to make is to a 17 certain extent we'd have to see this with the

18 alternate standards. But the deltas that 19 we're talking about often occur above these 20 LMLs anyway. So it's really just, and that's 21 what becomes important for them. 22 CHAIR SAMET: Okay, what about 8? Page 200

1 I think I heard L for that earlier. 2 DR. MILLER: Yes, I certainly 3 thought it was an L. 4 CHAIR SAMET: Okay, so 8 is an L. 5 All right, we're on the Chapter 8. 6 DR. BRAIN: Can I, just one add 7 on? I don't know that it belongs here or 8 somewhere else but, it seems to me at sometime 9 we should comment on next generation of 10 exposure assessment, you know, we should all 11 have iPhone Apps that would measure location 12 activity and ozone remote sensing, you know, 13 personal dosimeters. I mean as I look at this 14 I think, you know, we really need more 15 detailed information. And it doesn't exactly 16 belong here but somewhere I think we need to 17 put forward some of those possibilities. 18 CHAIR SAMET: Okay. Maybe iPhone 19 5 is going to have that. Everybody will want 20 that. Okay, 8, Number 1, this is long-term 21 exposure of respiratory mortality. 22 DR. RUSSELL: Aren't you currently Page 201 1 pretty far down that road, or -- 2 DR. HUBBELL: We are I mean again, 3 it's not a matter of can we do that or is it 4 feasible? It is feasible to do that and our 5 plan is to do that. We were just looking for 6 your input as to whether it was supportable to

7 do that. 8 DR. RUSSELL: I think it's high, I 9 mean it is, I think, a critical piece of 10 information to pass on. 11 CHAIR SAMET: Okay, we do want you

12 to correct the error.

13 DR. HUBBELL: Yes. 14 CHAIR SAMET: Let's see, 3. 15 DR. MILLER: Can you explain what 16 that means? You've used very crypted -- 17 DR. ANENBERG: Sure, so in the 18 current draft we intended to quantify res from 19 using the effect estimates from Bell et al. 20 (2004) for just May to September, and the 21 Zanobetti and Schwartz, using the Zanobetti 22 and Schwartz effect estimates for the matching202-234-4433 Neal R. Gross & Co., Inc. Page 202 1 period in that study which is June to August. 2 We actually only had city-specific 3 estimates from Bell et al. (2004) using all 4 year ozone data. So our suggestion was that 5 in the next draft we identify whether it's 6 possible to get just the May to September 7 city-specific estimates and use those. 8 CHAIR SAMET: Did Bell et al. have 9 any comments on this? Or as to availability? 10 DR. BELL: Oh, I'm working on it. 11 CHAIR SAMET: Oh, okay. 12 DR. MILLER: What's the advantage? 13 CHAIR SAMET: Et al. is not. 14 DR. BELL: Are you volunteering,

15 Jon?

16 CHAIR SAMET: What? 17 DR. BELL: Are you volunteering?

18 CHAIR SAMET: No. 19 DR. ANENBERG: So in the National 20 Scale Assessment, and because it's one grid 21 over the entire U.S., it really requires one 22 defined modeling period. So May to September Page 203

1 would be the lowest common denominator for all 2 locations. 3 CHAIR SAMET: So you're really 4 doing additional analysis then. 5 DR. MILLER: I forgot national 6 scale is in the title in this chapter. 7 DR. HUBBELL: Yes, in addition, 8 the other benefit of doing that is it allows 9 for more direct comparability between the 10 studies rather than, you know.

11 DR. MILLER: Yes. 12 CHAIR SAMET: Okay, what about 13 8.4? Sounds to me like this is, we've talked 14 about this, this is really lowish, as is 5. 15 All right then 8, actually, Fred, you had a

16 comment on these data and then we heard 17 actually from EPA that they did want to look

18 at these data. 19 DR. MILLER: Yes, they did but at 20 least in the write up you said there's an 21 awful lot of problems with the data so I was 22 taking in the context of just that, when they Page 204 1 articulated what might be able to be done with 2 it if they could do it here today, it had a 3 higher, you know, probability or rating if it 4 was up to me. So I guess I would advocate 5 this is as an M, we haven't had an M.

6 DR. HUBBELL: It's one of those 7 things that if we can get the data to work, we 8 think it has some value. But it's kind of a 9 high-risk, high-reward thing if we can get it 10 to work, so yes, and it is a lot of work 11 because it's a big data set. And we are 12 getting some help from our colleagues at ORD 13 but it's a big job. 14 DR. MILLER: I guess I still have 15 to, given everything else that you're doing 16 and knowing you're going to revisit this in 17 another five to eight years, no one has ever 18 made the five year cycle, that this still 19 ought to be an L. 20 DR. HUBBELL: Okay, that's fine 21 too. Thanks, Fred. 22 CHAIR SAMET: I think it's fine to Page 205 1 put L by things. So we will provide this, our 2 guidance to you. If nothing else, hopefully 3 it will allow you to think about the many 4 things you have to do and give some 5 priorities. 6 So what I'm going to suggest is 7 that we not start on the Welfare Risk and 8 Exposure Assessment, we finished the Health 9 Risk and Exposure Assessment, I think 10 adequately. Why don't we reconvene at 1:15 11 and at that point then we'll get back with the 12 schedule that's there for 1:30, okay? So 13 adjourned for an hour and ten minutes or so. 14 (Whereupon, the above-entitled 15 matter went off the record at 12:05 p.m. and 16 resumed at 1:19 p.m.)

17

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22202-234-4433 Neal R. Gross & Co., Inc. Page 206

1 A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N 2 (1:19 p.m.) 3 CHAIR SAMET: Okay, welcome back. 4 If everybody could take their seats, we are 5 ready to move on to the Welfare Risk and 6 Exposure Assessment long awaited by the team 7 to my right so we'll hear I guess from EPA.

8 MS. WEGMAN: This is Dr. Travis 9 Smith who will be doing the presentation.

10 CHAIR SAMET: You don't seem to be 11 on yet. Try now. 12 MS. WEGMAN: Are we ready now? 13 Okay, so this is Dr. Travis Smith. He's going 14 to do the presentation on the Welfare Risk and 15 Exposure Assessment. 16 DR. SMITH: I think we're on. I 17 think he said we're on so try and get some 18 slides up quick.

19 This will be somewhat shorter than 20 some of the other things. We'll hurry through 21 some of the discussion of air quality because 22 a lot of it's discussion we've already had.

Page 207

1 We have the slides. 2 So just really quick. I won't go 3 through all the people on this. It's just 4 obviously there's a lot of people involved 5 with this project, not just me sitting here 6 talking. 7 We have a lot of help, 8 particularly from the Forest Service with the 9 i-Tree model so just sort of acknowledge that 10 that's a group that we've, they've been very 11 helpful in addition to all the people in the 12 OAQPS with the EPA.

13 The structure of the Welfare 14 Assessment is very similar to the Health 15 Assessment. Couple less chapters I think but 16 we more or less followed the same sequence, 17 introduction, framework, scope. 18 I'm not going to really talk about 19 those in this part of the presentation. We'll 20 talk about those as we move through the

21 afternoon here. 22 And so I'll talk a little bit Page 208 1 about the air quality considerations, the 2 ecological effects and then the ecosystem 3 services and just briefly touch on the 4 synthesis chapter.

5 So we have talked a lot about the 6 air quality already and a lot of the issues 7 with this are going to be the exact same 8 things that have been discussed and so I'll 9 try to touch on what's different here. 10 This is we were using the W126 11 national fused surface for the recent air 12 quality. 13 For the current conditions, we 14 used the 2006 to 2008 monitor data and that 15 was fused with the 2007 CMAQ data and all this 16 was fused together using the enhanced Voronoi 17 Neighbor Averaging, eVNA, technique.

18 And the same for the Health 19 Assessment. The monitor data provided the 20 absolute W126 values and the CMAQ model data 21 determined the gradient between monitors. 22 And so there'll be some discussion Page 209 1 here of in the east there's not a lot of space 2 between monitors. In the western United 3 States there's obviously very large areas with 4 no monitors. 5 To rollback to just meeting the 6 current standard, we rolled back to meeting 7 the eight-hour standard, not the W126 8 standard, because the current secondary 9 standard is equal to the primary. 10 To do this, the monitors were 11 grouped together throughout the U.S., and if 12 at least one monitor was exceeding the 2006 to 13 2008 design value or above 75 ppb, the 14 monitors were rolled back.

15 And then from the rolled back 16 data, we recalculated the W126 and then 17 generated the fused spatial surface a second 18 time.

19 So see what these surfaces look 20 like. These actually highlight some of the 21 technical difficulties that have already been 22 discussed in great length here.202-234-4433 Neal R. Gross & Co., Inc. Page 210

1 You can see the forest fires in 2 Idaho sticking out in the upper, upper left 3 and in the rollback scenario, that because 4 there's no monitors there to roll back. 5 And there are some other technical 6 issues with this rollback that we know are 7 there and we're exploring different ways to

8 address those for the second draft. 9 And we're certainly hoping to get 10 more input than has already, CASAC's been 11 giving plenty of input on the rollback and the 12 air quality so we'll hopefully get more on 13 this particular surface as we move forward. 14 Then moving onto the ecological 15 effects in Chapter 5, we pulled forward the 16 causal and likely causal effects from the ISA. 17 I think the most important thing 18 here is to point out a lot of these we really 19 don't have anything other than just we know 20 it's a causal effect. We had no way to look 21 at them in a quantitative way for the risk

22 assessment. Page 211

1 And so for the ecological effects, 2 we looked specifically at the reduced 3 vegetation growth and the visible foliar 4 injury and those are the only things that 5 we've really been able to quantitatively look 6 at in this risk assessment. 7 And of those, only the reduced 8 vegetation growth, they're in the form of 9 relative biomass loss, that's the only thing 10 that we have a concentration-response function 11 for to be able to really assess incremental 12 changes in the effects of ozone. 13 In Chapter 6 we do use some of 14 these causal or likely causal effects to 15 qualitatively look at how that would relate to 16 ecosystem surfaces and I'll talk about that in 17 a couple of slides. 18 So looking at the relative biomass 19 loss, basically this analysis was completed in 20 the last review. We've updated it in this 21 review using the newer air quality data. 22 We have one new tree species so Page 212 1 there's 11 tree species that have a 2 concentration-response function for biomass

3 loss. 4 It is important and the biomass 5 loss function is calculated as a comparison 6 between varying ozone scenarios and a clean 7 air quality or zero ozone so that is how it is

8 calculated. 9 And we didn't recalculate those 10 numbers. Those are directly from the last 11 review and the technical documents that were 12 associated with the last review. 13 The species ranges for those 14 analyses were based on published U.S. Forest 15 Service data. Some of that data is very old, 16 from the early '70s. 17 And so for the eastern species, we 18 were able to update some of those ranges with 19 more recent Forest Inventory Analysis data 20 from the Forest Service. 21 For this particular analysis, we

22 were able to look at and assess both the Page 213 1 absolute biomass loss numbers across the range 2 of those individual species. 3 And we also looked at proportional 4 changes between the two air quality scenarios, 5 the recent air quality and then the rolled 6 back air quality surface. 7 A step that we tried to go, as 8 this was addressed some in the last review, 9 we've tried to expand on in this review, is to 10 use some form of abundance-weighted biomass 11 loss for the analysis. 12 And we think this is a very 13 important step of getting away from just 14 looking at effects on individual species to 15 trying to assess larger effects within 16 ecosystems. 17 In this case we used data from the 18 FIA program with the Forest Service to weight 19 the individual biomass loss values for each 20 individual tree species. 21 And we did it on a cell-by-cell 22 basis within the CMAQ grid but we were using202-234-4433 Neal R. Gross & Co., Inc. Page 214 1 the analysis of the actual, where we had 2 calculated the original biomass loss values.

3 We used Federal Class 1 and 4 designated Critical Habitat Areas as the 5 geographic endpoints, not necessarily as 6 anything more than an area that has been 7 designated as important to protect to give us 8 something to analyze as an endpoint. 9 Unfortunately, for this analysis 10 we were restricted to only the eastern species 11 so we only had eight species so this is 12 limiting the data.

13 And because there are so few 14 species, it makes it difficult to really 15 interpret what the absolute biomass loss

16 values meant and how that would relate to the 17 overall ecosystem. 18 So we focused in this analysis 19 specifically on the proportional change 20 between the two air quality scenarios. 21 For this draft we included only an 22 assessment of the Great Smoky Mountains. We Page 215 1 plan to include Rocky Mountain and 2 Sequoia/Kings National Parks for the second

3 draft. 4 For this instead of using the FIA 5 data for abundance value, we used U.S. 6 Geologic Survey and National Park Service 7 vegetation mapping of the National Park. 8 And we used abundance data in the 9 form of cover data and cover estimates of 10 individual species to weight the relative 11 biomass loss values. 12 And so I think it's important to 13 clarify because I think there's two different 14 ways we use this data. In this one we were 15 still focused only on the 11 tree species that 16 we had response functions for. 17 And one thing we're hoping to get 18 a little bit of input on is the ozone exposure 19 estimates for this were still based on the 20 national surface. 21 The 12-kilometer CMAQ grid is a 22 much coarser scale than the actual vegetation Page 216 1 mapping is and so we're hoping to get some 2 input on a better way to get a surface for the 3 parks but that's something we'll talk about

4 later. 5 Visible foliar injury is something 6 we're hoping to look at and we did look at 7 some in this draft but is definitely an 8 incomplete analysis in this draft. 9 We're hoping to include ozone 10 monitoring data from the Forest Health 11 Monitoring program where they have an ozone 12 damage index that they've calculated to a 13 number of points. 14 And we're working with the Forest 15 Service. The data need to be fuzzed at some 16 level for privacy issues and so we're working 17 with them to get as accurate of data as we 18 possibly can to reduce uncertainty within the 19 analysis. 20 In that analysis we're hoping to 21 also include moisture data in a regional scale 22 to try to account for moisture in addition to Page 217

1 the ozone. 2 Within the National Park, we used 3 the National Park's ozone-sensitive species 4 list I believe from the Baltimore conference 5 in 2003 and updated again I believe 2007.

6 For all of the eastern tree 7 species that we know are sensitive, we 8 calculated more of a national or at least the 9 eastern U.S. surface of the sensitive tree 10 species. These are not species necessarily 11 sensitive to biomass loss but sensitive to 12 foliar injury. 13 And then we looked at a finer 14 scale using the cover data within the park of 15 all species that are thought to be sensitive 16 and that goes across tress, shrubs and herbs. 17 And so we're hoping to get some 18 input on the best way to continue that 19 assessment because that does not include ozone 20 data at this point. It's purely cover 21 information about sensitive species. 22 And this draft also includes a202-234-4433 Neal R. Gross & Co., Inc. Page 218 1 screening-level assessment of visible foliar 2 injury risk in National Parks and that's an 3 update of a study that was done by Kohut in

4 2007. 5 And there are some very 6 interesting things with the study. We think 7 it's a very good way to look through the 8 screening level but we also had some questions 9 that we specifically asked for CASAC's input 10 on how to move forward or update the way that 11 assessment is done. 12 So Chapter 6, we move forward into 13 the Ecosystem Services Assessment. We used 14 the Ecosystem Services Framework based on the 15 Millennium Ecosystem Assessment of 2001 or

16 2000. 17 When we could, we did quantitative 18 assessments of ecosystem services that were 19 mostly based on the biomass loss. Some of 20 that included in addition to the actual 21 biomass loss and how that effects the crop 22 species the timber species. Page 219

1 We also looked at a couple of 2 different ways, at carbon sequestration and 3 pollution removal. 4 But as I mentioned before, a lot 5 of those services we just couldn't do a 6 quantitative assessment. There was just no 7 way to look at incremental changes and impacts

8 on ozone. 9 So for those we did include a 10 qualitative assessment, just hoping to provide 11 some context to the scope and magnitude of the 12 potentially effected services because there's 13 a lot of things that can be effected and 14 there's just not very many that we can 15 actually quantitatively assess at this point. 16 So looking at the services we 17 included, we did, the framework includes 18 regulating services, provisioning services, 19 cultural services and supporting services. 20 The services here marked with an 21 asterisk are things that we were able to look 22 at in this draft, includes the climate Page 220 1 regulation in the form of carbon sequestration 2 and food and timber products in the form of 3 the biomass loss curves that we've talked

4 about. 5 There's a number of other things 6 here, water and fire regulation, net primary 7 productivity, community composition and the 8 cultural services of non-use and recreational 9 value, that we just haven't quantitatively 10 assessed in this and we don't think we'll have 11 a way to probably do that. 12 Net primary productivity and 13 community composition are things that we're 14 looking at potential ways to get at those in 15 the second draft including models like PnET or 16 expanding into some other models using the 17 abundance-weighted data to try to assess 18 community composition changes. 19 On a national scale we use the 20 FASOM greenhouse gas model, the Forest and21 Agricultural Services Optimization Model22 Greenhouse Gas. That's a lot to say. Page 221

1 That quantifies incremental 2 effects of ozone-induced biomass loss on 3 timber and agricultural markets. It also 4 addresses climate regulation in the form of 5 changes in carbon storage. 6 This assessment used the 11 tree 7 species that we used in Chapter 5 in addition 8 to the agricultural species identified in the 9 ISA and all of those are input into this

10 model. 11 And one important note with this 12 model relative to the i-Tree model which we'll 13 talk about next is that this model accounts 14 for trade-offs between these species. 15 And so species that are included 16 in the FASOM model, we had to come up with 17 proxies for those species if we didn't have a 18 specific response function, otherwise they 19 would be given a beneficial preference in the 20 model as a trade-off of assuming they have no

21 effect from ozone. 22 And so we did ask for the panel's202-234-4433 Neal R. Gross & Co., Inc. Page 222 1 input on the proxies we used and how we went 2 about doing that because that certainly does 3 effect the output of this model as how we deal 4 with the species that we don't have response 5 functions for. 6 For Urban Case Study areas we used 7 the i-Tree model from the Forest Service and 8 the Forest Service that we've been working, I 9 say run in collaboration with. 10 And this collaboration is they did 11 all the work helping us and they've been very 12 helpful, and we did it in specific areas. 13 This estimates the ozone-induced biomass loss 14 effects on carbon sequestration and pollution 15 removal in urban systems. 16 We did it so far in five areas, 17 Atlanta, Baltimore and Syracuse, the cities, 18 and then the entire larger Chicago region and

19 then all of the urban areas across Tennessee. 20 These areas were selected in part 21 by where the Forest Service had quantified 22 data for the tree inventories in those cities Page 223

1 to be able to run the model and also of the 2 eight species that we can use which cities 3 actually had enough species to work with.

4 And most of these had 2 or 3 5 species present, accounting for 10 to maybe 20 6 percent of the total trees in the city. 7 And this is where i-Tree is 8 different than FASOM, is that i-Tree does not 9 include trade-offs between these species. 10 So the results from the i-Tree 11 model are based specifically just on changes 12 in those two or three tree species that occur 13 in each of those cities. 14 So some quick summary of some of 15 the key points, very incomplete at this point. 16 Biomass loss, the magnitude and shape of the 17 actual concentration-response functions varied 18 significantly between species. 19 But looking across all of the 20 species, there was about a 30 percent 21 reduction in biomass loss when the ozone 22 concentrations were reduced to just meeting Page 224

1 the current standard. 2 For visible foliar injury, 3 although we weren't able to do a large 4 quantitative assessment, we did find that in 5 some areas, particularly areas near Atlanta 6 and some other areas in the east, up to 80 7 percent of the tree cover are species that are 8 considered sensitive to visible foliar injury.

9 So there are some areas that are 10 certainly at risk but we have not included 11 ozone exposure into that yet. That's just an 12 assessment of the cover of those individual 13 species. 14 For ecosystem services there's a 15 lot of results in the report on the results of 16 FASOM but on average we did find a reduction 17 in commercial timber of about 5.2 percent of 18 biomass loss based on the exposure inputs. 19 In i-Tree, we're not going to go 20 into exact numbers with the i-Tree but we did 21 get significant reductions in carbon 22 sequestration and pollution removal based on Page 225 1 the response functions of the trees that were 2 input into the model. 3 Some potential updates that will 4 be from the second draft, there will be new 5 model runs for both FASOM and i-Tree for 6 alternate standards and we will have alternate 7 standards, same as in the Health Assessment. 8 We do plan to include uncertainty 9 analysis. That's something we're going to 10 hopefully, as we see exactly what analyses are 11 in this, then we'll be able to determine 12 better what kind of uncertainty analysis we

13 can do. 14 There'll be a more quantitative 15 treatment of both fire risk and bark beetle 16 risk in relation to ozone exposure levels. 17 And we're also exploring using the 18 model PnET to assess changes in net primary 19 productivity and water cycling, and we will be 20 completing the National Park studies. 21 So that is it for now, quickly, so 22 we can move on to something else.202-234-4433 Neal R. Gross & Co., Inc. Page 226 1 CHAIR SAMET: Okay, thank you. 2 One question, the last slide, it said 3 potential updates. What does potential mean? 4 DR. SMITH: I think that probably 5 is just, probably not worded correctly. That 6 should just say the updates we're planning for

7 --

8 CHAIR SAMET: So these are 9 definitely updates you're planning to make? 10 DR. SMITH: Other than, I think 11 PnET is the one that we're exploring whether 12 or not we can use that. We're hoping to get 13 some input from the panel on the use of PnET. 14 Certainly we will have more runs 15 of FASOM and i-Tree and we will include an 16 uncertainty analysis. We haven't determined 17 exactly what that's going to look like. And 18 National Parks will get done and the bark 19 beetle and fire risk will get done. 20 These are the updates that will be 21 coming and with the exception of PnET we're 22 certain of them, and PnET we're hoping to get Page 227 1 some input and we're still exploring how best

2 to use that. 3 CHAIR SAMET: Okay, thanks. Do 4 panel members have questions?

5 DR. WEATHERS: I have another 6 question along those lines. I thought I

7 understood that the FIA or FHM data would also 8 be used in this next round, either --

9 DR. SMITH: Yes. 10 DR. WEATHERS: -- synthesized by 11 the Forest Service or by you all. 12 DR. SMITH: I am working with John 13 Coulston at the Forest Service. They have a 14 certain range of the amount of distance that 15 they have to fuzz their data points by. 16 And I'm working with him to see if 17 instead of fuzzing the data if he can actually 18 give me the CMAQ grid cell that it falls in so 19 that way I could reduce it from the standpoint 20 of my analyses or the analyses we do with it. 21 That will at least reduce the 22 uncertainty of making sure that I don't have Page 228 1 a data point assigned to the wrong grid cell 2 that we're assessing it in. 3 But, yes, we are planning to do 4 that and that should be on this slide, that we 5 are planning to include that. 6 CHAIR SAMET: Okay, others? Okay, 7 good. Thank you. Then we'll move on to the 8 public comment session. We have one speaker 9 registered to talk, Jacqueline Patterson on 10 behalf of the NAACP. Let's see, Jacqueline

11 Patterson. 12 DR. NUGENT: Ms. Patterson, are 13 you on the line? We understood you were going 14 to provide comments this afternoon.

15 CHAIR SAMET: It's not 2:00 so we 16 will -- 17 (Off microphone discussion.) 18 CHAIR SAMET: My timekeeper says 19 we have to wait till 2:00. So we'll move on 20 to then begin our review and then come back 21 for public comment period. So first, Chapters 22 1, 2, 3. This is Kathy and Peter. Page 229

1 DR. WEATHERS: Okay, thanks. We'd 2 like to do something a little bit different 3 for these introductory chapters, which is 4 we'll address the questions but we'd like to 5 raise some overarching concerns and issues 6 that underpin all of this section. 7 And so I'll start and identify a 8 few and then turn it over to Peter and the 9 rest of the welfare folks if they have 10 something to say. 11 So there are some overarching 12 concerns and one of them has to do with 13 looking at individual species versus 14 aggregated species throughout this document 15 and I think that we'll have a healthy 16 discussion about that. 17 But there are some pros and cons 18 and concerns about aggregation, that species 19 aggregation, and we'd like to hear a little 20 bit more from you about the wisdom and 21 motivation of doing that. 22 I think that Peter Woodbury will202-234-4433 Neal R. Gross & Co., Inc. Page 230 1 address the issue of not using some of the 2 crop yield data to the extent that they might 3 be used and also how sensitive species versus 4 non-sensitive species are used in this 5 analysis. 6 Another overarching issue that I'm 7 sure will come up in later versions has to do 8 with uncertainty, which you touched on, and 9 especially understanding the methods for 10 fusion, for gap filling. 11 The way in which data are 12 spatially extrapolated or combined I think is 13 not illustrated very well in this document and 14 the devil's in the details here. 15 So in future versions and as part 16 of this discussion, we ought to get some 17 clarity on those analyses and fusion analyses. 18 I asked the question about the FIA 19 and FHM data. We may want to have a little 20 bit longer discussion about how those data 21 will be used moving forward. I think those 22 are the major overarching issues that IPage 231

1 identified. 2 There are some specifics as well 3 that appear in the conceptual model and the 4 introduction as well and throughout and those 5 have to do with all of the figure legends and 6 table legends. 7 I guess I would ask that they're 8 clear and that those figures and tables could 9 stand alone with a figure legend. 10 It's kind of a frustration to be 11 looking at data and data presentations and not 12 be clear about what the legends are. Howie, 13 do you have something to add to that? 14 DR. NEUFELD: Yes, just related to 15 that, many of them are missing units so be 16 sure to have units on there. 17 DR. WEATHERS: So with that said, 18 let me briefly go through my answers to the 19 questions. So these are mostly yes and no 20 questions, which is probably good for you. 21 And I think the introductory and 22 background material, especially background on Page 232 1 the previous materials, is appropriately 2 characterized and useful so I found that 3 introduction useful. 4 The conceptual model is also good. 5 There are some details that I will pass on in 6 my individual comments that we don't need to 7 go through here. 8 This chapter and a number of other 9 ones also need some copy editing clearly, and 10 the scope seems to be well communicated as

11 well. 12 I was struck actually by looking

13 at the PA. It seems that the PA was much more 14 succinct in some ways than this scope document 15 and where there's overlap I would look to the 16 PA for some clear language. 17 And somewhere, and maybe it's in 18 the last chapter and not here in the scope, it 19 seems that it would be really useful to have 20 a list of data and synthesis needs that would 21 result in a more robust analysis five years 22 from now, so keeping those in the forefront I Page 233 1 think would be quite useful. 2 And, again, if history repeats 3 itself, this, you know, kind of stepping aside 4 or, you know, skipping aside the uncertainty 5 and variability section will probably come 6 back to haunt you. Peter, you want to -- 7 DR. WOODBURY: Well, I'll also 8 start with some overall topics that pertain to 9 more than one chapter and more generally to 10 the approach used for the risk analysis. 11 I appreciate all the effort that's 12 gone into developing this welfare risk 13 analysis. 14 I think EPA has made a creative 15 effort to try to look at a lot of potential 16 endpoints and different types of effects of 17 ozone, different types of vegetation and 18 different environments. 19 And I think the use of ecosystem 20 services as a conceptual framework is helpful 21 and it's also timely. To some extent it's a 22 change in language but I think it is a helpful202-234-4433 Neal R. Gross & Co., Inc. Page 234

1 framework. 2 I think as far as sort of a 3 process comment, there's some efficiencies 4 presumably to be gained by getting our 5 comments on a partial draft as you're doing

6 here. 7 You know, if we give comments that 8 indicate you're headed in a productive 9 direction or in some cases otherwise, that 10 might help you be efficient with your efforts 11 but, again, I, you know, maybe open this up to 12 the rest of the panel for comments on this. 13 I think there's also a risk that 14 you're taking that you may get a lot more 15 helpful comments than you're expecting on the 16 next go around when there's a more complete

17 draft. 18 I'm not quite sure how to phrase 19 this, but I think in trying to sort through 20 the parts that were complete and the parts 21 that were not, I guess I'm trying to elaborate 22 on what I just said. Page 235

1 And I think what I just said is 2 with an incomplete draft it's a little harder 3 as a reviewer to pay complete attention to all 4 of the pieces since it's not always clear 5 which are the most important pieces, which 6 pieces are sort of more finished or less 7 finished. I guess I'll stop there. 8 Another sort of, perhaps just a 9 process comment. You know, I appreciate that 10 the charge questions represent things that are 11 on your mind as you're doing the analysis and 12 areas where we might be helpful. 13 I just wanted to reflect that, you 14 know, they were formulated to elicit a yes or 15 no answer in most cases and they were also in 16 most cases quite narrow. 17 So I did not find them 18 particularly helpful in reviewing this 19 document at this stage. I did my best to 20 respond to them and I have sent those

21 comments. 22 I found there were several issues Page 236 1 that I felt strongly need to be addressed in 2 this document that I didn't feel really were 3 reflected in the charge questions. 4 And I'm going to focus the rest of 5 my kind of overall comments on those and I 6 basically went through my more detailed 7 comments and tried to summarize what I felt 8 were these overarching issues. 9 And I will send you these in 10 addition to the more detailed comments that I 11 sent previously, so I've actually sent them to 12 Angela already for distribution. 13 I think my biggest concern is I 14 feel there needs to be a great deal more 15 attention and a different approach for looking 16 at crop yield loss. 17 As summarized in the ISA, there's 18 very strong evidence going back for decades 19 that ambient ozone exposures in many locations 20 and years are causing significant and 21 substantial yield loss for sensitive crop 22 species. There's also similar evidence for Page 237 1 some tree species. 2 In the jargon of ecosystem 3 services, food and feed production are a 4 critical provisioning service and I think 5 there needs to be at least equal effort and 6 analysis dedicated to crop yield loss as there 7 is currently for forest tree analyses. 8 So for sensitive crops such as 9 soybean, I think they should be addressed as 10 individual species. 11 There's obviously a utility in 12 trying to look at multiple species, but there 13 are sensitive species such as soybean that 14 deserve to be looked at as individual species. 15 I also think it's important to use 16 a different approach than FASOM in the way 17 that it's being used to look at the crop yield

18 loss. 19 And part of my concern about that 20 is I think that it's important to look at 21 higher ozone regions and lower ozone regions 22 separately.202-234-4433 Neal R. Gross & Co., Inc. Page 238

1 And that's because kind of 2 averaging them together or looking only at the 3 total sort of net economic impact I think 4 actually obscures important real impacts in 5 the real world, real detriments to welfare 6 that are not captured in that approach. 7 So what I mean by that is the 8 FASOM model is trying to look at a sectoral 9 impact, so the entire agriculture sector as 10 well as the forest sector nationally. 11 But actually what happens with 12 ozone exposure for a sensitive crop is that 13 there are winners and losers, so in high ozone 14 regions you have significant and substantial 15 yield loss. In low ozone regions you don't. 16 Now, at a national level when you 17 merge those together you're kind of losing 18 that impact. You're getting only a net 19 impact. So the way I'm looking at it, in a 20 high ozone region farmers are losing income 21 due to crop yield loss. 22 And the FASOM analysis essentially Page 239 1 says, well yes, those farmers are losing 2 income but farmers in another region of the 3 country with lower ozone are getting greater 4 income so it kind of comes out as a net wash 5 if you will, a very small net effect. 6 But I think the farmers in a state 7 or a multi-state region with significant yield 8 losses, I don't think they're going to be very 9 happy that they lost income due to ozone. 10 I don't think they're going to 11 feel like, well, that's okay because somebody 12 in another state made more money, that evens 13 it out. I don't think that's an appropriate 14 way to look at yield loss. 15 DR. BRAIN: Why do the other 16 farmers make more money? Because the cost of 17 crops are higher or -- 18 DR. WOODBURY: Well, so the 19 approach in an economic model like FASOM is 20 that if you have lower total crop production, 21 then the price per unit will go up. 22 DR. BRAIN: So it's like the Page 240 1 drought this summer where there are winners as

2 well as some losers. 3 DR. WOODBURY: Right, right. 4 DR. BRAIN: If that's the case, 5 then the consumers are also losing and the 6 food prices are going up. 7 DR. WOODBURY: They may but again 8 that, yes, that impact may, the impact to 9 consumers because the crops physically are 10 mixed together and then sold in a commodities 11 market, you may not have as much of a 12 differential impact on consumers unless 13 they're buying that commodity locally. 14 So I kind of envision that this 15 kind of differential impact might be greater 16 for producers than consumers, at least for 17 these commodities, you know, like soybean that 18 are traded pretty widely, traveling pretty

19 far. 20 For other crops that are sold more 21 locally, you could certainly have an effect

22 for consumers. Page 241

1 And another point could be that if 2 ozone is causing substantial yield loss to a 3 sensitive crop species, you know, something 4 like soybeans is a global commodity.

5 So there could also be a loss of 6 competitive advantage between the U.S. and 7 another country such as Brazil if they're not 8 experiencing any ozone-induced yield losses. 9 Another topic that is on your list 10 for getting more attention is competition 11 among species, so that's on your list and I 12 just wanted to elaborate on that point a 13 little bit. 14 So for forest species in the 15 eastern U.S., in many cases they're growing in 16 mixed species stands so you have species that 17 are more sensitive to ozone growing with 18 species that are less sensitive. 19 They are competing for resources 20 such as light and, you know, it's challenging 21 to model that kind of competition and the 22 effect of ozone on that competition.202-234-4433 Neal R. Gross & Co., Inc. Page 242 1 But I think it's important to look 2 at this fact, that many of these species are 3 growing in competition with each other. It 4 has a couple of important implications. 5 For one thing, since species are 6 competing, this could exacerbate the impacts 7 of ozone on a sensitive species. 8 So if a sensitive species is 9 growing a few percent less per year but it's 10 competing with something that's less 11 sensitive, that impact could be exaggerated. 12 So it's losing competitive ability 13 and the effect could be even worse than just 14 that few percent at the scale of a whole stand

15 of trees. 16 So that's a way that you can have 17 a greater impact than you would predict just 18 by looking at a seedling exposure-response 19 function. 20 On the other hand, because these 21 species are competing, our modeling work and 22 that of other folks that's in the literature Page 243 1 would suggest that if you sum up the ozone 2 impacts on individual species in a stand, that 3 could be greater than the impact on the total 4 growth of the stand because the species that 5 are less sensitive are going to take advantage 6 of the greater light, et cetera. 7 So in that way you can have less 8 effect on total biomass production in a stand 9 than you would expect. That doesn't mean 10 there are no impacts. 11 If you're eliminating ozone 12 sensitive species, some of those are going to 13 be important commercially, important for 14 wildlife, et cetera, and I realize that, you 15 know, this is a challenging thing to model but 16 I think that issue needs to be addressed. 17 Another sort of broad suggestion 18 I'd like to make is do not average effects 19 among sensitive and less sensitive species. 20 So what I mean by that is for the 21 crop impacts if you just look at total effects 22 on all the crops, the ones that are sensitive Page 244 1 and not, it gives an impression of a fairly 2 small, you know, welfare impact. 3 But if you have major species, 4 again, I'm picking on soybean just because 5 it's so widely grown and so well known to be 6 sensitive to ozone, if you have impacts on 7 soybean, that's important even if there's very 8 little impact on another major crop like corn. 9 So when you combine those effects 10 together, I'm not sure you're really 11 addressing the welfare impacts adequately. 12 Similarly, I would suggest not 13 averaging impacts across high ozone and low 14 ozone regions and I sort of touched on that 15 issue already. But, again, I think it can 16 give a false impression that there's very 17 little impact at the national scale. 18 There's nothing wrong with looking 19 at the average impact at the national scale, 20 but if you have large regions of the country 21 with substantial impacts, you also want to pay 22 attention to those regional impacts. Page 245

1 Another general issue is scaling 2 from tree seedlings to mature trees in 3 forests. This is not a new issue. This has 4 gotten a lot of attention in previous

5 documents. 6 And I know you, you know, thought 7 about this but I do think there needs to be a 8 little bit more attention on that issue in 9 this document. 10 Then the issue of background 11 level. I think we've heard something about 12 this previously and it seems I've heard it in 13 previous meetings as well. 14 This is a perennial issue that's 15 not going away and, again, some clarity about 16 how that's going to be handled here will be 17 helpful. 18 And then my last overall comment 19 is I understand the need to keep this document 20 succinct and that's a good thing. I think 21 referring to the ISA is good. 22 And there are some lengthy202-234-4433 Neal R. Gross & Co., Inc. Page 246 1 appendices to this document, such as the one 2 about the FASOM modeling. 3 And I think it's important that 4 some of the key assumptions in something like, 5 as an example, the FASOM modeling, some of the 6 key assumptions need to come out of that 7 appendix and go into the risk assessment. 8 So I'm not talking about adding 9 pages but just a few sentences that say this 10 is the model, this is why we used it, these 11 were some critical assumptions that we made 12 and this is why we made them. That's it for 13 my sort of overall comments. I can stop

14 there. 15 CHAIR SAMET: Okay. All right, 16 thank you, Peter. It might have been quicker 17 if we asked you what you liked. 18 DR. WOODBURY: What I liked? Yes. 19 (Laughter)

20 CHAIR SAMET: Just a comment. I 21 mean, I think your comments on the process 22 issues were well taken and I think also the Page 247

1 same issues surface with the Health and Human 2 Exposure Assessment. 3 And I've felt that this is 4 something we need to circle back to in general 5 probably tomorrow for discussion. I think you 6 phrased the issues well. 7 Let me ask if others want to 8 comment. I mean, I think there was a 9 tremendous amount of useful guidance on 10 general issues from what was said and 11 presumably we'll come back to some of those as 12 we go through the specific chapters and come 13 to the end, but let me open up for discussion.

14 DR. HUBBELL: If I could make one 15 clarifying comment on the use of FASOM. Would 16 that be okay? 17 Okay. So FASOM, because a lot of 18 people aren't familiar with these types of 19 broad-scale economic models -- just for 20 background, my Ph.D. is in agricultural 21 economics so I've dealt with a lot of these 22 models over time. Page 248 1 But the key thing to remember in 2 all these and what makes it very difficult in 3 modeling them is that you cannot look at any 4 individual species in isolation in these 5 models because they're based entirely on 6 looking at the trade-offs the farmers make in 7 terms of making decisions about the crops they 8 plant, the acreage they plant to them, whether 9 they plant them to agricultural crops or 10 forest crops. 11 And so you simply can't 12 disentangle them in a very easy way. It 13 doesn't mean there aren't other analyses that 14 could accompany those type of assessments. 15 But the models by their very 16 nature are intended to address the fact that

17 farmers do make these trade-offs. 18 It's equivalent to thinking about 19 a stand competition model in a natural forest. 20 Here it's guided by human actions, not by 21 natural competition. 22 But it's important to be able to Page 249

1 make sure that those are modeled and 2 understanding how welfare impacts occur for 3 people in different parts of the country. 4 Again, the ability to look at 5 disaggregations by region and so forth, that 6 may be something we can do. 7 But the ability to just split out 8 individual species, especially for crops, is 9 very difficult to do while still reflecting 10 how it actually effects welfare from an 11 economic standpoint which is how we've 12 generally judged agricultural impacts, is 13 through the way they impact agricultural 14 markets. So I just wanted to clarify that 15 those are, they're inherently linked. 16 DR. WOODBURY: Thank you and I 17 appreciate that linkage and I understand the 18 motivation and utility of this model and 19 approach and I realize this has been used for 20 a number of years. 21 But I've had the same objection 22 for a number of years as well, that it's202-234-4433 Neal R. Gross & Co., Inc. Page 250 1 useful but not adequate, and I'm not 2 suggesting trying to create a new model or 3 disaggregate FASOM. 4 I would suggest in addition some 5 very simple spatial extrapolations to say we 6 know what the seasonal ozone exposure is for7 a number of years. We have the exposure8 response function. 9 You put those two together and you 10 have an estimate of yield loss for a sensitive 11 species throughout the country. 12 I think there are some of these 13 kinds of analyses that can be done with the 14 existing data. That doesn't have to be 15 complicated. 16 It's not really breaking new 17 ground but it's an additional way to look at 18 crop yield loss that I think is important in 19 addition to the national, you know, that kind 20 of integration that happens with FASOM. 21 You know, I don't know if this is 22 a good analogy and I'm not sure I remember the Page 251 1 correct terminology, but maybe it's an analogy 2 in what came up earlier today with human 3 health where people are avoiding ozone 4 exposure. 5 Well, this is an important 6 behavior that we need to think about, but in 7 terms of a risk analysis, it doesn't mean that 8 we just say, well, people are not going 9 outside so there's therefore no risk. 10 I would say if people are choosing 11 to plant something else instead of soybeans 12 because of yield loss, that's something we

13 want to know about. 14 We don't just want that only to be 15 rolled into a model where it's fairly 16 invisible and pretend that nothing happened. 17 CHAIR SAMET: Okay. Any other 18 comments on these introductory chapters? I 19 will say that Chapter 2 in this document was 20 much more of a conceptual model than Chapter 21 2 in the Human Health and Risk Assessment 22 document. You might look back to it. But it Page 252 1 clearly strove to set out a conceptual model. 2 Let's go back to then the public 3 comment period and let me check if Jacqueline 4 Patterson is here or available by telephone. 5 Okay. 6 DR. NUGENT: Ms. Patterson, are 7 you on the line? 8 CHAIR SAMET: Okay. All right, 9 then we will keep going to air quality. Back 10 to our air quality team. 11 DR. WOODBURY: Excuse me, Jon. If 12 I could just give one comment on Chapter 2. 13 CHAIR SAMET: Sure, Peter. Sure,

14 sure. 15 DR. WOODBURY: So I liked Chapter 16 2. You know, the question was is it useful? 17 Yes, it's useful and it should be retained. 18 I do think in this chapter and elsewhere some 19 more effort can be made on language and we 20 heard this earlier today.

21 There's a lot that's not known 22 about ozone effects but there's a fair amount Page 253 1 that is known and I think the policy analysis 2 had some good, clear phrases of what was known

3 and wasn't known. 4 I think there's room for 5 improvement there as well, but I think it 6 would be helpful to have more clarity about 7 what's relatively well known and what's 8 relatively poorly understood. 9 CHAIR SAMET: Okay, thanks. 10 Daniel. 11 DR. JACOB: Okay. Yes, so Chapter 12 4 on air quality, there is some significant 13 overlap with a similar chapter in the REA for 14 Health and it's overall very good.

15 I have a bunch of comments but I 16 just want to talk here about the most 17 important ones. 18 The first one is how the fused 19 national scale data were obtained. There's a 20 reference from Wells but more information I 21 think would be useful. 22 To tell the truth, I found the202-234-4433 Neal R. Gross & Co., Inc. Page 254 1 data to look weird but maybe it's just me. 2 But when I look at Figure 4-3, I see that W126 3 is more of a problem in Utah than in New 4 Jersey. 5 Well, I'm exaggerating. It's 6 about the same in Utah as in New Jersey. I 7 don't know what goes in there. 8 So my understanding from the 9 discussion that we had this morning was that 10 the fused data is really anchored by all of

11 the network data. 12 But then I don't know what happens 13 over much of the Intermountain West. The 14 Intermountain West, when you look at Figure 4- 15 3, is after California where the action's at 16 in terms of trying to meet the W126 standard. 17 And kind of wonder why that is. 18 Is that because CMAQ is making a lot of ozone 19 from fires? So we have the hotspot over 20 central Idaho which I understand is going to 21 go away after you use the climatological 22 average fires. Page 255

1 But that brings in another 2 question which is that it seems like air 3 quality models are making too much ozone from 4 fires and it's a point of controversy, but 5 when you talk to a lot of people, that's a 6 general opinion. 7 And in particular in 2007 when we 8 had those raging fires in central Idaho, the 9 eight U.S. stations for ozone didn't see any

10 elevated ozone. 11 I looked at the data for Glacier 12 National Park and the CASTNet sites. You 13 don't see any ozone enhancement from the Idaho 14 fires. 15 And I've done aircraft missions 16 with NASA in which we've looked at plumes from 17 boreal forest fires. We don't see any ozone 18 production from fires. 19 Hanwant Singh published a couple 20 papers recently on looking at the fires in 21 2008 in California and those fires he found 22 produced ozone only when mixed with urban Page 256 1 plumes. 2 It is kind of interesting and it's 3 interesting because the exceptional events 4 that are removed from this map are precisely 5 the 2008 California fire events that when you 6 had elevated ozone it probably wasn't just

7 natural. 8 In any case, there is a lot of 9 concerns here associated with fire effects on 10 ozone. This is an important comment I have 11 for the Policy Assessment because it actually, 12 Chapter 1 goes quite a bit into the fires. 13 But I would suggest paying some 14 attention here. You know, there's a lot of 15 uncertainty about the effect on fires. I'm 16 not saying I have a better solution. 17 But clearly some attention should 18 be paid to the potential for some error 19 associated with the ozone production from 20 fires and how it would impact the W126 21 standard. All right, so that was my point. 22 So in terms of getting some more Page 257 1 confidence in those fused data surfaces, you 2 know, I'd like to know for example were all 3 the ozone monitors really used in constructing

4 them? 5 For example, if the CASTNet 6 monitors were not used, then perhaps they 7 could be used as a verification. 8 And perhaps a comparison of the 9 fused data to observations at places where you 10 didn't use those sites for constructive fuse 11 data now would be very, very useful in getting 12 us confident and in particular in the 13 Intermountain West which seems so interesting 14 in terms of the elevated W126. 15 Okay, I mentioned the exceptional 16 events in California and this was a comment I 17 had for the Health REA too. It's not very 18 clear to me why you removed the exceptional

19 events. 20 You know, it's a little bit like 21 removing the natural background but you don't 22 remove the natural background here. Maybe202-234-4433 Neal R. Gross & Co., Inc. Page 258 1 some explanation would be useful. 2 The last important point I want to 3 make is with regard to the background and 4 Peter said always the background. 5 Well, here again, you know, the 6 background is very important and you look at 7 the Intermountain West and you wonder how much 8 the background is contributing to this W126. 9 And so since I think there's 10 consensus that you're going to go to HDDM for 11 the next draft of the REA and I certainly 12 think that's the best thing to do, it becomes 13 very compelling to properly characterize the 14 background in CMAQ because you're going to be 15 using the CMAQ background in going to the W126 16 and to meeting the W126 standard. 17 And so this might mean going back 18 to the ISA and having a comparison with the 19 CAMx and GEOS-Chem background calculations

20 that are there. 21 And if you don't want to go back 22 to the ISA, I guess that's fine but then there Page 259

1 should be some discussion of this in the REA 2 chapters, either for the Health REA or the

3 Welfare REA. 4 It's more critical for the Welfare

5 REA than for the Health REA because the 6 Welfare W126 standard is much more sensitive 7 to the background, well, more sensitive to the 8 background. 9 The last point I wanted to make 10 was with regard to the strategy for meeting 11 the W126 standard on the national scale and 12 here it's different from the Health REA where 13 you're just focusing on those 16 urban 14 regions. 15 This is actually something that I 16 did not get from the chapter, that you were 17 going to do this, you would try to meet the 18 W126 standard on a national scale using the

19 fused data and now HDDM. 20 And what I learned from Travis's 21 presentation is that you were going to group 22 the data into large areas and apply HDDM into Page 260 1 individual areas. Well, that makes a lot of

2 sense. 3 I didn't see any documentation of 4 this in the chapter. Maybe it's because it's 5 somewhere else in the report or maybe it's 6 because it needs to be there. 7 DR. SMITH: I was just talking 8 specifically about the rollback surface we 9 used and that's how this particular rollback 10 surface in here was calculated. I believe all 11 of that is in the Wells appendix -- appendix. 12 DR. JACOB: Oh, okay. 13 MS. WESSON: Yes, maybe I can 14 address the myriad of comments. 15 Let's see, exceptional events. So 16 the exclusion of the exceptional events, the 17 only thing that was excluded were the fires in 18 2008 from California and that was a mistake on 19 our part so we will in the second draft 20 include those fires in California. 21 Of course when we are rolling back 22 to simulate just meeting the standard, any Page 261 1 concurred exceptional events would not be 2 included in the rollback but it would be 3 included in the surface that would be going 4 into the analysis. 5 You mentioned the HDDM. So we 6 talked about HDDM with respect to -- 7 DR. JACOB: Oh, I'm sorry to 8 interrupt, Karen. But, okay, but it was 9 diagnosed an exceptional event in California. 10 Nobody bothered about the fires in central 11 Idaho, that they also would be exceptional

12 events. 13 MS. WESSON: Actually they weren't 14 because there was no concurred event, so it 15 has to be concurred by the region and then 16 excluded from the data. The only excluded 17 events were the California fires. 18 (Off microphone discussion.)

19 MR. WELLS: So the reason the 20 exceptional events, the concurred exceptional 21 events, are excluded is when we do our rule 22 makings and then when we compare air quality202-234-4433 Neal R. Gross & Co., Inc. Page 262 1 data to the standards, we remove exceptional

2 event data from the standards. 3 And so to more accurately reflect, 4 you know, just meeting those standards for the 5 rollback scenarios, we want to remove those 6 data also because that's what we would do with 7 those data in the event that we were actually 8 comparing them to a standard. 9 DR. JACOB: Yes, okay, but what 10 about the hotspots in central Idaho? 11 MR. WELLS: Well, that's not based 12 on any monitoring data. There were no 13 concurred exceptional event data in there 14 because none of the monitors were affected by 15 the wildfires. That was purely a modeling 16 artifact. 17 DR. JACOB: I know, but you're 18 still going to, from my understanding, in 19 trying to meet the W126 standard, then you're 20 going to try to beat down the ozone when there 21 were central fires in Idaho and I'm not sure 22 how you're going to do this but it doesn't -- Page 263 1 do you understand my problem? 2 MS. WESSON: So I think this is 3 something that we would want some comment on. 4 So the way that the surface was done for just 5 meeting the current eight-hour standard, the 6 monitors were adjusted to meet the standard 7 but not all grid cells were adjusted to meet

8 the standard. 9 DR. JACOB: Well, that's correct. 10 My understanding that for the Health REA you 11 only wanted your 16 urban areas to meet the 12 standard, whereas here you're going after the 13 whole country including central Idaho. 14 MS. WESSON: Well, I think that's 15 a question. So what we have done is all the 16 monitors have been rolled back to meet the

17 standard. 18 But because of the way that the 19 fused surface is done, you can have areas 20 between monitors that are higher than the 21 actual monitor reading so we haven't rolled 22 back those areas, so we haven't rolled back Page 264 1 grid cell by grid cell. 2 What we've done is we've rolled 3 back the monitors. I mean, I guess we were 4 thinking more in line with an attainment 5 demonstration. The monitors need to be in 6 attainment. Those would come down. 7 But, you know, there may be 8 unmonitored areas that may have higher 9 concentrations and that's kind of the, you 10 know, the method we followed. 11 But I think, you know, we would 12 like feedback of whether you think that in 13 simulating just meeting the standard if we 14 need every single grid cell to meet that 15 standard. 16 DR. HUBBELL: For this draft we 17 looked at meeting an eight-hour standard. 18 Monitors were at the eight-hour standard it 19 was being monitored for. 20 What we're really trying to get 21 comment on is as we look towards W126 22 standards and looking at alternative W126 Page 265 1 standards which presumably we're going to want 2 to meet in other places than urban areas, what 3 is the best way for us to target or simulate 4 attaining those standards in places that we're

5 most concerned about or where we would be 6 likely to monitor? 7 And that's really the question, is 8 how do we deal with that design issue of how 9 do we simulate attainment when we don't have 10 monitors and we don't have non-attainment

11 areas? 12 MS. WESSON: And then maybe I can 13 address a couple of your other comments. One 14 of the things you mentioned was the HDDM, so 15 we talked about it with respect to the Health 16 analysis.

17 And what we have done there or 18 what we're proposing to do there is to look at 19 a city and then we would look at the monitors 20 within that urban area and roll back those. 21 And as I was alluding to earlier, 22 there's more challenges to looking at202-234-4433 Neal R. Gross & Co., Inc. Page 266 1 attainment of, you know, 1,000 monitors across 2 the entire United States because when we look 3 at an urban area and we look at, you know, 10 4 monitors there, we simulate just meeting the

5 current standard. 6 But on a national scale, it's how 7 do you make, I mean, which monitor would you 8 choose to just meet the current standard and 9 then are you over-controlling in other areas? 10 And so the way that we have done 11 the rollback is to group certain sections of 12 monitors together and I think that it's 13 documented in the Wells et al. memo, the exact 14 methodology that we followed as far as 15 grouping those monitors.

16 And then we rolled back those 17 monitors to simulating just meeting the 18 standard and we used the quadratic rollback 19 approach to do that. 20 And I think that, you know, we 21 don't have a good idea of how we would apply 22 HDDM in those cases and how we would apply it Page 267 1 nationally to simulate just meeting the 2 standard given the breadth of the monitors 3 that we're talking about.

4 CHAIR SAMET: So let me ask. We 5 still have two of our signed commenters to go 6 through. Do you have more comments here? 7 DR. JACOB: I guess I don't 8 understand why you couldn't use HDDM in this 9 case in the same way as you do for urban 10 areas. You're doing it for individual 11 regions. 12 MS. WESSON: So, I mean, that's a 13 good point. So what we could do is look at 14 individual regions together and think about 15 applying HDDM. But I think applying the 16 rollback with all the different regions 17 interacting together -- 18 DR. JACOB: Not interacting.

19 MS. WESSON: Yes. 20 DR. JACOB: Okay. 21 CHAIR SAMET: Fred, to this point

22 or -- Page 268

1 DR. MILLER: Just so the health 2 people can follow a little better, could you 3 please tell me the units of W126 because it's 4 missing from the graphs, the figures. 5 So what are the units? I think 6 it's a 90-day moving average or what, could 7 you just define it for us? 8 DR. SMITH: So W126 as it's 9 calculated here, it's a three-year average. 10 It has the weighted curve and it is in ppm 11 hours, is the units of that.

12 DR. MILLER: I see. 13 DR. SMITH: And it is at the 14 highest three month, summed three month and 15 then averaged over three years. 16 DR. MILLER: Okay, thank you. 17 CHAIR SAMET: Okay, Ted. 18 DR. RUSSELL: Yes, not much to add 19 from what Daniel said. I actually do think 20 that it might be good to show a little bit 21 more about the different dynamics of ozone in 22 a rural area just since it is different than Page 269 1 what a lot of people are thinking about, so I 2 think somewhere here it would be good to show 3 that and comment on it. 4 I do think also here you have to 5 discuss how well the air quality monitors do 6 at more rural sites because typically 7 everybody talks about how they do at urban 8 sites. 9 So I think that issue has to be 10 addressed and I realize we talked about it 11 right before lunch. I still think there are 12 ways to use HDDM. 13 I mean, doing it by the regional 14 approach or something like that do make sense 15 and I think it's just a matter of maybe some 16 more discussion and thinking about that and I 17 do think it would be a preferable way. 18 CHAIR SAMET: Okay, George. 19 MR. ALLEN: I'll join Daniel in my 20 concerns about rural fire ozone production as 21 noted before. The national scale fused 22 surface -- I think is a pretty good approach.202-234-4433 Neal R. Gross & Co., Inc. Page 270

1 I'm a little concerned out west 2 where the monitors are sparse and the 3 topography is complex. That's a challenge no 4 matter how you slice and dice it and that's 5 not going to go away. 6 The rollback, we keep talking 7 about that, whether or not you could use HDDM. 8 It is a resource issue and we did talk offline 9 about it before lunch a bit. 10 If we could figure out a way to do 11 it for this, I mean, the way the current draft 12 reads it says rollback, the quadratic 13 rollback, with a U.S. background as a lower

14 bound. 15 But, yes, certainly if we could 16 work out a way where it's not too resource 17 intensive and put HDDM into this as well that 18 would be great, but I acknowledge that the 19 agency's resources are constrained and so is 20 the time given the schedule that we're looking

21 at. 22 But clearly HDDM, if we can do it Page 271

1 in the context of a national scale domain for 2 the secondary, would be an improvement. 3 That's it. 4 CHAIR SAMET: Okay, let's see. Do 5 my job. Peter, actually would you mind taking 6 on the comments for Chapters 1 and 3 and then 7 Daniel maybe for this chapter?

8 Let me ask for those of us who are 9 neither Daniel, Ted or George and are a little 10 confused at this point between what you're 11 doing for the human side on air quality and 12 the ecological welfare side, I just -- I think 13 people are going to look at this and get 14 confused, ordinary people, and 15 epidemiologists, the broad mass of humanity. 16 (Laughter)

17 MALE PARTICIPANT: Not the 18 engineers. 19 CHAIR SAMET: Not the engineers. 20 They understand everything. Would it be -- I 21 mean, I'm just throwing this out. 22 Would it be valuable to have a Page 272

1 table that said sort of here's how we're 2 dealing with air quality on the Human Health 3 Risk Assessment, here's how we're doing it on 4 the Ecological Welfare Assessment? 5 There are differences. I

6 understand that there are reasons that there 7 are differences. You're facing somewhat 8 different challenges and I think that's come 9 up in the discussion. 10 But I think it's going to be quite 11 confusing to people who look at these 12 documents and perhaps in the Policy Assessment 13 because there's going to be sort of underlying 14 different modeling and rollback strategies as 15 I understand the story you're telling. 16 And so, you know, I throw this 17 out. I mean, if you had something up there 18 now that had two halves to it that put the 19 story together, it might make sense to me 20 because, right, we keep hearing the same words 21 over and over but the same model is not being 22 used exactly the same way, so I just throw Page 273

1 that out for discussion. 2 DR. GRANTZ: Would you want that 3 to appear in both the Health and Welfare REAs

4 or --

5 CHAIR SAMET: Let's hear from 6 people. Howie, you wanted to comment here? 7 DR. NEUFELD: Yes, I want to 8 comment on something else after you're done 9 with this. 10 CHAIR SAMET: Okay. Ted. 11 DR. RUSSELL: I was thinking about 12 it and since I won't be here tomorrow I'll 13 just put in my two cents worth. 14 I think that belongs in the PA and 15 that there could be a good integrative summary 16 in the PA that goes into that. You know, you 17 might want parts -- 18 CHAIR SAMET: Okay, somewhere. So 19 we might just hold the thought but, I mean, I 20 think, and again this goes back to the 21 integration which you do want to do in the end

22 so.202-234-4433 Neal R. Gross & Co., Inc. Page 274 1 DR. GRANTZ: Jon, I think one 2 reason to have something like that, whether 3 it's a table or just a paragraph explaining 4 those differences and having it here, would be 5 almost as a goad to integrate them when you 6 could and as much as you could. 7 There are going to be some 8 differences but they've tended maybe to drift 9 apart more than they needed to, and if forced 10 to sit down and align them, that might 11 actually be beneficial in terms of the next

12 draft. 13 DR. BRAIN: And I think if you 14 want to talk about the differences, you should 15 also perhaps begin by the similarities. I 16 mean, ozone is ozone. You'd think that some 17 elements of exposure assessment should be the

18 same. 19 So I think, you know, such a piece 20 should include both, you know, what they do 21 have in common as well as perhaps differences 22 in the way they're treated. Page 275

1 CHAIR SAMET: Good point. So 2 think about it and I think maybe the PA, 3 wherever Ted suggests, would be valuable. So 4 let's open up for discussion on -- 5 DR. NEUFELD: I just want to 6 clarify some equations there on Page 4-5. You

7 have the N100. 8 For those of us, you know, doing 9 physiology and stuff, we usually treat this 10 slightly differently. We do N100 is any hour 11 equal to 100 or greater and you have only 12 greater than 100. 13 I know that sounds minor but it 14 can add a lot of hours to the index. So just 15 figure out why you picked that one when most 16 people do it the other way around.

17 And then the SUM06. That's not 18 the definition of SUM06 that I know of. 19 That's an AOT60 or something. I mean, SUM06 20 is just simply the sum of all the hours, 60 21 parts per billion or greater. 22 But if you subtract 60 off it, Page 276 1 that's an AOT60 just like the European AOT40. 2 So which SUM06 did you actually use? Did you 3 use the traditional SUM06 or, and just get, 4 you know -- 5 (Off microphone discussion.) 6 MR. WELLS: So, yes, you're 7 correct. The way it's defined in here is 8 actually more what you were calling the AOT, 9 in this case it would be AOT60, but we could 10 go back to a more traditional SUM06 in the

11 second draft. 12 DR. NEUFELD: Yes, I mean, they're 13 also highly correlated but this is one I've 14 never seen and everybody is very familiar with

15 the SUM60 so. 16 DR. HUBBELL: I think one of the 17 things we'll need to check is which one was 18 actually used in the Kohut analysis since 19 that's what we were replicating. 20 DR. NEUFELD: Okay, okay. 21 (Off microphone discussion.)

22 DR. NEUFELD: I can't recall off Page 277 1 the top of my mind what Bob used but Bob was 2 doing traditional stuff. It was probably a 3 regular SUM60.

4 MALE PARTICIPANT: SUM06. 5 CHAIR SAMET: Okay. Other 6 comments on Chapter 4? Okay, so why don't we 7 do Chapter 5 and then maybe we'll break. 8 Kathy. 9 DR. WEATHERS: Okay. I'll make 10 some general comments again. The specific 11 comments will be in the individual comments. 12 And maybe we ought to break this 13 down as the comments about the relative 14 biomass loss to begin with and then go to the 15 foliar injury risk. 16 So in general, I like the approach 17 and I'm pleased to see that it's been vetted 18 in the past as well. That's always a good 19 sign. 20 You had some specific questions 21 for how to analyze and compare the data, which 22 I think all of us might respond to a little202-234-4433 Neal R. Gross & Co., Inc. Page 278 1 bit differently. 2 It seems to me that aggregating 3 the data is necessary for a national 4 assessment and a national standard but I know, 5 again, some of my colleagues will have a 6 little bit different view of that. 7 So I think combining the 11-tree 8 species and combining the quantitative data 9 that exist is important for extrapolating to 10 a national scale assessment. 11 I think the importance values and 12 using the RBLs with the importance values is 13 really important, again for extrapolating to 14 a national scale assessment. I applaud the 15 use of those kinds of metrics and weighting. 16 And I certainly don't have any 17 recommendations for a wider range of tree 18 species given that there aren't data 19 available. 20 Hopefully the FIA and the forest 21 health data may fill some of those holes but 22 it's awfully difficult to extrapolate when Page 279

1 there aren't data there. 2 I also like the idea of using the 3 Class 1 Critical Habitats for case studies. 4 I would also consider, I know that somewhere 5 you suggested that you might and rejected it, 6 but some of the coastal areas, Acadia or Cape 7 Cod National Seashore. 8 I like those areas in particular 9 because there are finer-scale data as you've 10 mentioned. You're using those data and you 11 had a question about how to fuse those data. 12 I do see that as a major challenge 13 when you've got CMAQ data at 12 kilometer grid 14 cell size and you've got 30 by 30 or 10 by 10 15 meter data that can't be used unless you can 16 figure out some way to generate ozone data at

17 the same scale. 18 So I think there's some potential 19 there and I would be inclined to exploit that 20 potential for getting a finer spatial scale 21 analysis for these national parks where there 22 are much more data than across the nation. Page 280

1 So that kind of takes us to Number 2 10 with the RBLs and the Class 1 area so those 3 are my overarching comments on those 4 questions. Should we try David or Peter or

5 Helen? 6 CHAIR SAMET: Howie will be next. 7 DR. NEUFELD: Okay, I'm going to 8 just highlight a few, well, actually a lot of 9 my comments here but not go through everything 10 that I've written so you can see that. I 11 agree with much of what Kathleen said. 12 I just bring attention to this one 13 paper by Matyssek. I looked to see if it had 14 been cited but it wasn't, but it's 15 distinguishing between the effective dose and 16 the uptake, you know, essentially trying to 17 get a more mechanistic approach here. 18 Now, there may not be the data to 19 do anything with that but at least I think if 20 one mentions that you're aware of it then we 21 know that at least for future purposes that 22 we're going to try to get better at doing Page 281

1 this. 2 I'm a little concerned about that3 graph in Chapter 5 of the sensitivity, the C4 R, you know, the concentration-response 5 functions. 6 First off, I think you should say 7 where you got that. I couldn't figure out 8 where you got all those from. Is that listed 9 in there? I mean, maybe I missed it but I 10 couldn't tell where each of the tree species, 11 like where you pulled the data from. 12 (Off microphone discussion.) 13 DR. NEUFELD: And I guess my main 14 concern is looking at the Sugar Maple data. 15 To me that's an inherently insensitive tree 16 and it looks extremely sensitive in this 17 analysis. 18 I went through and I looked up 19 papers on Sugar Maple and ozone, you know, 20 most of them by Mary Topa. 21 And in the 2001 article that she 22 had in Plant, Cell and Environment she states,202-234-4433 Neal R. Gross & Co., Inc. Page 282 1 "There's no statistical difference in the dry 2 weight of seedlings in the one times and the 3 1.7 ambient treatments." 4 And many of her effects didn't 5 occur until she got to three times ambient, so 6 I just don't understand. Based on that, it 7 sounds like it's very insensitive and then 8 here it sounds like it's very sensitive. 9 DR. SMITH: The preliminary 10 comments, I did look up that paper and in that 11 figure Sugar Maple is actually very 12 insensitive until over a W126 of about 20 to 13 25 ppm. 14 And so without looking, the 15 ambient concentrations in a lot of the places

16 are 10 to 15. 17 And so it is quite possible that 18 that's exactly, but once it does get to the, 19 kind of, that's one of the species that kind 20 of seem to behave almost like a threshold 21 where it was very insensitive and then there 22 was a rapid, a very small area of W126 Page 283

1 exposure which it becomes very sensitive. 2 I looked at that paper and it 3 wasn't in the same metrics and I didn't have 4 time to figure out exactly what metrics level,

5 how those related to a W126. 6 But I don't know that it's 7 completely inconsistent with that because the 8 level where it does become very sensitive is 9 actually above 20 to 25 and so that species 10 does behave very interestingly in that figure. 11 DR. NEUFELD: Okay. And it's just 12 amazing I think after 50 years of work that we 13 don't have more, you know, response functions. 14 It just tells you something about, you know, 15 what's been going on, you know, funding and 16 everything. 17 But did you mine the literature 18 for -- I mean, what were the criteria for 19 determining whether you could include them in 20 this graph? 21 DR. SMITH: From this graph I 22 pulled only from the ISA. They only came from Page 284 1 the ISA and so I did not bring any species 2 that were not listed in the ISA.

3 And so I would have to defer to 4 Jeff and Chris in the back of the room to 5 explain exactly all of their criteria. Most 6 of these species were in the last review, 7 except for cottonwood. 8 DR. NEUFELD: Yes. Maybe I'm 9 thinking if you go back further there are 10 other species possibly that could be mined but 11 maybe there are criteria you have that 12 preclude that. 13 (Off microphone discussion.)

14 MR. HERRICK: Calculate the W126s 15 for it. So these are all the species that we 16 have W126 concentration-response functions

17 for. 18 So there might be others out there 19 but we don't have access to the hourly data so 20 we can't consistently look at them across 21 different species. 22 DR. NEUFELD: So like some of Page 285 1 those earlier studies would just have the 2 total sum at the end of the experiment but 3 didn't tell you the hourly values. 4 MR. HERRICK: Yes, they might have 5 did an average. People in their publications 6 didn't consistently calculate W126 and so we 7 made an effort in the ISA to actually contact 8 authors and we hardly got any. 9 Just a lot of the studies were so 10 old that people didn't have their hourly data 11 anymore so we weren't able to construct more, 12 so this is sort of the best we can do. 13 I mean, we got it from the Gregg 14 study and we got the FACE hourly data but that 15 was about it. 16 CHAIR SAMET: I think an important 17 question here is if somebody went to the ISA, 18 and I can't remember what's there, would they 19 see what you just said set out in a 20 sufficiently transparent way on --

21 MALE PARTICIPANT: I can't hear

22 from over here.202-234-4433 Neal R. Gross & Co., Inc. Page 286 1 CHAIR SAMET: So my question was 2 and, you know, simply maybe we can look at 3 this again. 4 But if you went to the ISA and 5 tried to understand the search strategy to 6 identify these concentration-response 7 relationships, would you find a transparent 8 exposition of how you came to identify them in 9 a way that could be replicated? 10 MR. HERRICK: Yes. You would find 11 that we cited a report by Henry Lee et al. 12 from EPA who did this for the, I mean, these 13 were put together in 1996 for the 1996 review. 14 So these are the same exact response functions 15 that we used in 1996 and in 2006 and now. 16 The only thing that's been added 17 is the cottonwood and that's what we added in 18 the last ISA so everything is documented 19 through those reports. 20 DR. NEUFELD: Okay. I just want 21 to emphasize what others have said before, 22 that combining all the analyses of the trees Page 287 1 into one analysis I think puts too much weight 2 on the insensitive species and obscures the 3 sensitive ones. 4 Let's see. If we go to the other 5 alternative geographic areas that could be 6 used, I had mentioned in here a couple of 7 national parks and also the western portion of 8 Pennsylvania there in that -- which is known 9 to be in the high ozone area and also has many 10 of the species that are sensitive to ozone in

11 that area. 12 It's the premier area for growing 13 black cherry, for example, so that would be a 14 good site to concentrate on.

15 The other one I wanted to talk 16 about was if we go to the, let's see which 17 question is it? This would be 11c. This is 18 getting into the Kohut analyses. 19 The REA and the PA, you know, go 20 to great lengths to justify using the 21 cumulative indices such as the W126. And 22 here, based on this analysis, you can move a Page 288 1 park down in its sensitivity category whether 2 or not the N100 is exceeded, solely on that 3 basis. 4 So you could -- like I put here in 5 my comments, you know, you could have fairly 6 high ozone all the way from 60 to 99, or in 7 your case up to 100 actually because it's the 8 way you defined it, and that's going to cause 9 significant biological impacts and that would 10 make the park still at high risk. 11 So I'm wondering, you know, if 12 there's some way of adjusting the way that you 13 did this. 14 And there's also an inverse 15 relationship sometimes between soil, moisture 16 and ozone exposure so you could be at high 17 risk with lower ozone or you could have years 18 that don't have peaks above 100 but still have

19 lots of ozone. 20 So I was suggesting maybe some 21 sort of three-dimensional space if that's 22 possible. I think it's more realistic. It's Page 289 1 what the plants are actually experiencing in 2 terms of their risk. 3 And the last part for this is 4 concerned about, this is question 12b, the 5 appropriateness of the mapping with the 6 understory species, I think is what you're 7 asking in this point. 8 So the understory species, of 9 course, in a dense cove hardwood forest are 10 going to experience much less ozone than the 11 canopy trees so they're not as high risk in

12 that sense. 13 And also there's lower deposition, 14 lower wind speeds, a whole bunch of things 15 which would probably make them less sensitive. 16 It doesn't mean injury doesn't occur. I mean, 17 we've seen it. 18 But I think if there's a way of 19 taking that into account I think it's just 20 more realistic and I think if you could try to

21 do that. 22 Also I want to also get away from202-234-4433 Neal R. Gross & Co., Inc. Page 290 1 the idea, I've heard it mentioned several 2 times here, that plants in the understory have 3 better water, moisture conditions, relations 4 and stuff like that. 5 In fact, it could be just the 6 opposite. There's a tremendous amount of 7 competition, root competition, in the 8 understory. 9 And studies have shown, especially 10 at like the Duke Forest here, that when you 11 trench the forest floor, you get an abundance 12 of growth because you've cut off the 13 competition for water from the adult trees. 14 So, in fact, understory herbs may 15 be under more water stress, not less, and that 16 could also effect how they react. So those 17 are my major comments and then the rest of it 18 is --

19 DR. HUBBELL: Can I ask for a 20 clarification on the Kohut analysis that we 21 did, the screen-level assessment? 22 DR. NEUFELD: Yes, yes. Page 291

1 DR. HUBBELL: One of the struggles 2 we're trying to work through is how important 3 it is to stick to the metrics used by the 4 primary author in trying to replicate an 5 existing analysis versus should we develop a 6 new screening analysis methodology that 7 incorporates your comments. 8 And I think we're comfortable 9 going either direction but we wanted to make 10 sure that you understood our motivation was to 11 try to replicate an existing analysis and 12 therefore we kind of were stuck with the 13 assumptions made. 14 DR. NEUFELD: Yes, I guess I was 15 just a little concerned that if you make it 16 all dependent on that one metric, you know, 17 like where you have to have both indices to be 18 classified as high, that you are categorizing 19 a park then as less sensitive when, in fact, 20 it's still sensitive. 21 So I just felt it was too coarse 22 of a cutoff so I was thinking if you could Page 292 1 just refine that. 2 I still think the ideas, you know, 3 essentially soil, moisture and ozone are the 4 same but I think that the cutoffs are too 5 abrupt. 6 DR. HUBBELL: Okay, so the answer 7 then, if I'm interpreting correctly, is it's 8 okay with you as a reviewer if we modify that 9 Kohut model without putting a whole new peer 10 reviewed publication into the ISA? That's

11 what -- 12 DR. NEUFELD: Yes, because I think 13 the spirit is still the same and the 14 underlying bases are the same. You're just 15 redefining the thresholds for putting them 16 into the different categories. 17 DR. HUBBELL: Okay, thank you. 18 DR. WOODBURY: I'd like to chime 19 in on that briefly. What you need are 20 essentially the exposure-response function for 21 the foliar injury. 22 I mean, I don't know if those Page 293

1 levels were chosen because there were data, 2 you know, using those levels to identify 3 whether, you know, foliar injury would or

4 would not occur.

5 So I don't remember the exact 6 reason that Bob Kohut chose those levels, but 7 if you have data to support any other 8 quantitative level I think that's fine. 9 DR. GRANTZ: Is your question 10 whether to keep the two standards, so you have

11 to meet the W126 and the N100 standard? 12 DR. HUBBELL: The question was 13 simply that, you know, the Kohut analysis 14 identified certain benchmarks, certain 15 thresholds that were then used to define 16 whether an area was sensitive or not sensitive 17 or at risk or not at risk. 18 And the question was should we 19 incorporate, as you said, take the spirit of 20 the model and incorporate additional 21 information to update it or do we need to 22 stick with what was used there and simply202-234-4433 Neal R. Gross & Co., Inc. Page 294 1 report the results of applying it to new air 2 quality? 3 And my understanding is that 4 you've provided comments that will allow us to 5 update the model and make it more respective 6 of current science. 7 DR. GRANTZ: Yes, and I would 8 agree with that too. 9 CHAIR SAMET: Okay, Dave. 10 DR. GRANTZ: Yes, I don't think 11 I'm going to go through my step-by-step 12 comments that are written down. 13 But the big overarching issue here 14 for me is how you're going to aggregate 15 species in different areas and whatnot. 16 From a policy perspective, I think 17 it is really important, and I agree with Kathy 18 on this, that there has to be some aggregation 19 so that you're carrying forward a few or 20 single impacts that can be sort of readily 21 interpreted. The risks of that are obvious. 22 So summary one would be that you Page 295 1 really need to lay out as you do it why you're 2 going which direction. You know, why are we 3 aggregating here? Why are we not aggregating

4 here? 5 You know, in my individual 6 comments I make the suggestion that, and it's 7 actually question 8c I think. You suggest 8 that we use the most sensitive species and 9 then carry that sensitivity relationship

10 forward. 11 And I put in my comments that I 12 think that's probably not appropriate because 13 it's not defensible. It makes the entire 14 system seem more sensitive than we might be

15 able to defend. 16 However, we've been having 17 discussions over here the last couple of days 18 and I'm not sure that I still maintain that 19 position, although it has some merit. 20 The problem with that is it 21 doesn't protect the most sensitive species and 22 that can be catastrophic for a number of Page 296 1 reasons that I'm sure you appreciate.

2 So I'm not sure what I'm 3 recommending the right way to go is. I think 4 at this point, being that this is, you know, 5 Version 0.5, you at the very least need to lay 6 out the choices that you've made and why 7 you've made them and what the consequences 8 are, you know, not in 200 pages. 9 But I think that's a really key 10 thing that you just can't finesse. It's 11 really important whether you aggregate or you 12 don't aggregate. 13 And I still maintain that you need 14 some key individual benchmarks that you carry 15 forward or endpoints that you carry forward. 16 Okay, now, Howie, you want to -- 17 DR. NEUFELD: I just wanted to ask 18 you a question, I think maybe Travis or Lydia 19 or Bryan, anyone. 20 So what is the EPA obligated to 21 do, say, if faced with a situation in this 22 ecological context where you have a sensitive Page 297 1 species and if you then aggregate species and 2 you set a higher standard based on that 3 average and it fails to protect that sensitive 4 species which then may be at risk to, say, be 5 extirpated from an area or even go instinct? 6 I give you as an example the 7 recent birch species that was discovered by 8 Virginia Tech researchers where at one point 9 there were maybe 20 trees for the entire 10 species. 11 And birch is known to be sensitive 12 to ozone and if you set it higher and that 13 species was at risk and then those 20 trees 14 died out the whole species would be gone. 15 How does the EPA deal with a 16 situation like that? It's an easy question to

17 answer. 18 MS. WEGMAN: Yes, I was going to 19 say I don't have any simple answer for you on 20 that one. You know, we have to look at the 21 data we have, you know, all the data we have, 22 and see what we are protecting.202-234-4433 Neal R. Gross & Co., Inc. Page 298 1 You know, when we look at people 2 from the health side or we're looking at 3 obviously just one species but we look at4 protecting everybody, including sensitive sub5 populations or at-risk populations as we call

6 them now. 7 We don't have to protect every 8 individual but we do have to look at sensitive 9 populations as well as the general population. 10 So if you were to analogize that, 11 we would be trying to protect sensitive 12 species as well as a broad array of species 13 but perhaps not every single individual member 14 of the species. 15 So I don't know if that analogy 16 works so well in the welfare context but 17 that's, you know, an initial way to think 18 about it. 19 DR. HUBBELL: One other thing on 20 that, I'll just elaborate a little bit, is the 21 language used for the primary standards and 22 the secondary standards is different. Page 299

1 And it talks about adverse effects 2 on public welfare and deciding whether 3 protecting an individual species is protecting 4 public welfare. That's something that we're 5 wrestling with. 6 That's one of the reasons why 7 we're moving towards an ecosystem services 8 oriented framework is to try to address 9 impacts on public welfare rather than trying 10 to focus on individual species or individual 11 locations and species. 12 That said, as Travis pointed out, 13 we've now started also trying to identify case 14 study areas that are of specific interest, 15 that have been identified as needing 16 protection, like Federal Class 1 areas or 17 Critical Habitat Areas. 18 So technically if a birch tree was 19 in a Critical Habitat Area for birch trees, we 20 would identify it as something that we would 21 want to protect. 22 MS. WEGMAN: Maybe. Page 300 1 DR. HUBBELL: Maybe, I'm sorry. 2 MS. WEGMAN: Yes, and the other 3 thing of course we're always trying to define 4 is what is adversity? What constitutes 5 adversity and is it adverse if we lose the 6 last 20 birch trees of a specific kind of 7 birch? 8 DR. NEUFELD: Yes, and not to 9 complicate things and I don't want to drag it

10 on but -- 11 MS. WEGMAN: I should say adverse 12 to public welfare. 13 DR. NEUFELD: Yes, and if you do 14 set this risk analysis at a point where a 15 species has the potential, and I'm just saying 16 potential, doesn't mean it's going to happen 17 but, to go extinct does that become in 18 violation then of the Endangered Species Act?

19 MS. WEGMAN: That's another 20 question entirely.

21 DR. NEUFELD: Yes.

22 CHAIR SAMET: So we haven't heard Page 301 1 from Peter yet. We have two, are these on 2 this point then for -- 3 DR. MILLER: Yes, it is. 4 CHAIR SAMET: Okay, go ahead. 5 DR. MILLER: If you're talking 6 about 5-1 and talking about aggregate or not 7 aggregate, there are a number of statistical 8 issues that you better take account of. 9 These curves clearly show that you 10 do not have parallel line assay and so the 11 combination of things in terms of slope ratio 12 assay and weighted variances and all of this 13 stuff has got to be totally taken into

14 account. 15 And it's no easy job and the 16 answer will depend on each delta down that the 17 answer will change. 18 So those of you that want them to 19 aggregate, realize you're talking about mixing 20 apples and oranges in the hope you get fruit 21 cocktail. It's a tough one.

22 DR. SMITH: I have one202-234-4433 Neal R. Gross & Co., Inc. Page 302 1 clarification on the aggregation, is in 2 putting that in the idea was not to replace 3 looking at individual species. It was as an 4 additional way to summarize. 5 I mean, I didn't intend that as a 6 way to, we're not going to talk about 7 individual species. It was just a way to, 8 here are all the species and what can we say 9 about this as a whole across the country? 10 So I want to make sure it's clear 11 that that was intended to be a comment not a 12 question. 13 DR. GRANTZ: My comment was 14 intended to encourage you in that regard. I 15 think that is important for regulatory and for 16 public understanding reasons. I think that's 17 really quite important. 18 CHAIR SAMET: Okay, Joe.

19 DR. BRAIN: I want to know what we 20 say about evolution in relation to sensitive 21 species because even if it's sensitive within 22 that species there's variation in Page 303

1 susceptibility. 2 And with slow changes in ozone, 3 isn't it likely that more resistant strains 4 will inevitably take over? Is that an 5 important consideration and is it dealt with 6 adequately? 7 DR. NEUFELD: I'm trying to 8 remember. I think it was discussed somewhat 9 in the ISA. There are some studies that show 10 within just one year changes in genotype 11 frequencies after high ozone years. 12 But there's some controversy with 13 those studies because it's also confounded 14 with drought. But there is some evidence that 15 you can have rapid shifts in population due to 16 selection by ozone. 17 DR. BRAIN: It is different than 18 people. We have huge numbers, shorter 19 generation times. One could expect rapid 20 adaptations given enough diversity.

21 DR. NEUFELD: But we have the 22 paradox that we've been looking at these Page 304 1 things now for 60 years and the sensitive 2 species are still there so the only 3 explanation -- 4 DR. BRAIN: I mean, maybe that's 5 worth commenting on, that the sensitivity of 6 a particular species has been relatively 7 stable, you haven't seen drift in response in 8 the higher ozone levels or lower ozone levels.

9 DR. NEUFELD: When there have been 10 controlled studies, they've shown directional 11 selection. But in the field what may be 12 happening is that ozone is fairly stochastic. 13 Correct me if I'm wrong because you guys are 14 much more up on the year-to-year variation. 15 So you may have directional 16 selection for a few years in high ozone and 17 then you have a period of respite where you 18 have low ozone and the sensitive individuals

19 come back. 20 And so as this oscillates, you 21 know, it keeps them in the population as 22 opposed to completely eliminating them.Page 305

1 DR. SMITH: We are also dealing 2 with, some of the tree species we're talking 3 about short, some of the tree species actually 4 do have very long generation times. 5 And though you may have seedlings 6 one year, the next year it's a different, the 7 seedlings are coming from the same parent tree 8 and so you can get rapid shifts back and forth 9 with that. 10 CHAIR SAMET: Okay, so why don't 11 we go on and hear from Peter? I think he 12 wanted to speak anyway.

13 DR. WOODBURY: Just one last 14 comment on that topic. I think the challenge 15 again is what's an adverse welfare effect? 16 And I think that's a general issue. 17 You know, this is a challenge you 18 all are well aware of and I think that is a 19 challenge for the ecosystem services framework 20 and you've acknowledged that. 21 There are a lot of linkages, there 22 are a lot of conceptual models that have202-234-4433 Neal R. Gross & Co., Inc. Page 306 1 substantial support to say here's a chain of 2 events that seems likely. There seems likely 3 to be an influence of ozone. 4 But once you get into those causal 5 chains, it's very challenging to be 6 quantitative with them and, you know, I think 7 this question of, you know, essentially 8 evolutionary selection by ozone is another one

9 of those.

10 CHAIR SAMET: Dr. Grantz. 11 DR. GRANTZ: I wanted to basically 12 finish what I was going to say about Chapter 13 5 if I could. 14 CHAIR SAMET: Oh, okay.

15 DR. GRANTZ: Thanks.

16 CHAIR SAMET: We wandered. 17 DR. GRANTZ: Yes, that was good. 18 It was a good discussion. But there was a 19 question about this new emphasis on ecosystem 20 services and I wanted to put my two cents in 21 in favor of that. 22 I think that's very important in Page 307 1 terms of bringing back some of these esoteric 2 concepts to humans. I think that's very 3 important. 4 But following on from that, my 5 reading of Chapters 5 and 6 was just a slog, 6 you know? I thought it was incredible 7 repetition and bringing up something and then 8 analyzing it later. 9 And I wondered if, A, those two 10 could be brought together a little bit, even 11 the chapter titles. One is Ecological 12 Effects. The other is Risks to Ecosystem 13 Services. 14 It seems to me that ecosystem 15 services could give more relevance to 16 ecological effects if they were all brought 17 together because each of those services comes 18 from some ecological impact. 19 And if that was just laid out 20 concept by concept, taking it all the way 21 through to what you're going to do with it 22 risk-wise, I think it would be, A, easier to Page 308

1 read and a lot easier to understand. 2 And it would give more relevance 3 to some of the things that you kind of throw 4 out there even though in some cases you're not 5 going to come to a quantitative risk 6 assessment anyway. 7 But you might as well do it right 8 at the time that you bring it up because then 9 it's clear why you're not going to be 10 quantitative about it and it would also 11 shorten this thing a fair bit I think. 12 CHAIR SAMET: Okay, thanks. 13 Anything else on the chapter? 14 DR. GRANTZ: No, that's all I

15 have. 16 CHAIR SAMET: Okay. So, Peter, 17 comments on Chapter 5.

18 DR. WOODBURY: The reason I'm 19 hesitating is since I spent quite a bit of 20 time on my general comments, I'm quickly 21 trying to see if there's anything that I 22 haven't already covered in here. Page 309

1 DR. WEATHERS: While Peter's doing 2 that, may I ask a question of the EPA, which 3 is focusing on the Class 1 areas makes a lot 4 of sense as I said before. 5 But is it a challenge at all given 6 that many of them have complex and 7 heterogeneous terrain, they have sensitive 8 landscapes, if not species? 9 Does it present a policy challenge 10 if those are the focal areas, or is it a 11 policy advantage because they have to be 12 protected? You know, they're anomalous in 13 some ways. 14 DR. SMITH: Also the availability 15 of ozone monitors. 16 DR. HUBBELL: Yes, there are 17 benefits in terms of some of them have ozone 18 monitors in the parks which is a benefit. It 19 is also a benefit that they have been 20 identified as needing protection. 21 The question of the heterogeneity 22 within the systems and the uniqueness of them,202-234-4433 Neal R. Gross & Co., Inc. Page 310 1 yes, I'll let Travis discuss whether or not 2 that's a problem or not. 3 But it's certainly something that 4 we wouldn't want to necessarily extrapolate

5 from them to make a statement to that other 6 systems but there are uniquely sensitive 7 systems in some cases that may be parts of the 8 sensitive populations we're interested in 9 trying to protect. 10 But, again, you know, that's 11 something that we can certainly discuss, how 12 to characterize uncertainties there. 13 DR. SMITH: We used the same CMAQ 14 data so it was the same 12 by 12 grids. And 15 so the fact that they are places, like 16 Linville Gorge is one of the areas. 17 And that's certainly an area that 18 I don't know the ozone exactly there but I'm 19 sure that it doesn't match exactly what the 20 CMAQ grid says when you look across the 21 terrain in the gorge. 22 And that's a problem with any of Page 311

1 them. That is what we have. In some of them 2 they're very small and so we're limited. 3 There's only two or three CMAQ grid cells that 4 actually intersect it. 5 The ozone exposure is a problem in 6 those in that we don't have a way to get into 7 a finer scale than the CMAQ grid, at least for 8 this draft and I don't see a simple way of 9 getting past that for the next draft. 10 And so that is an issue and I 11 think it may be something I need to make sure 12 to be clear that that is a known issue with 13 using those but we're not going to have a way 14 to work with those other than to acknowledge 15 it. 16 CHAIR SAMET: Okay, let's see. 17 Peter, anything else to add or? 18 DR. WOODBURY: Yes, I'm not going 19 to go through my detailed comments except for 20 just one topic on Table 5-7. 21 And this goes back to the kind of 22 modification of the Kohut risk analysis. I Page 312 1 did want to make a couple of comments on this 2 topic. 3 One, in the table the moderate 4 risk class is not included in this table and 5 I wasn't sure if there was a reason for that. 6 I think three classes is fairly few and two is

7 fewer. 8 MS. LAMSON: Sure, I can quickly 9 clarify that for you. So this table -- oh, 10 I'm sorry. Hi, I'm Amy Lamson. I did the 11 Kohut analysis. 12 So this table was just showing the 13 higher and lower risk class. The main 14 difference between the moderate and the high 15 rating is the number of years that meet the 16 criteria, so I'm more than happy to add a note 17 to clarify that. 18 So for example, if at least three 19 years met the criteria, then that was 20 classified as high risk. If only one or two 21 years, that was classified as moderate risk. 22 DR. WOODBURY: So I'm still not Page 313 1 hearing a justification for going from three 2 classes to two. I understand what you just 3 said. 4 MALE PARTICIPANT: Why don't you 5 have moderates in there?

6 MS. LAMSON: Because the 7 differential is just something that's not 8 arrayed on this table but I'm happy to add 9 that if that's the recommendation from this 10 panel. 11 DR. HUBBELL: It was actually one 12 of the classes it just wasn't in this one. 13 DR. WOODBURY: Okay, and I guess 14 another comment on this analysis which would 15 be more effort but in general I'm in favor of 16 trying to be quantitative whenever possible. 17 So, you know, I think the Kohut 18 analysis was, you know, trying to look at a 19 lot of parks, some without any exposure data 20 in some kind of tractable approach and I 21 understand wanting to be tractable. 22 But essentially, to the extent202-234-4433 Neal R. Gross & Co., Inc. Page 314 1 that the underlying data or response 2 relationship supports a quantitative, you 3 know, a number here rather than just a high, 4 medium and low, that would be helpful. 5 And I don't have an opinion right 6 now of, you know, whether the foliar injury 7 data would support that. 8 In other words, do you really 9 have, you know, exposure-response functions 10 that would allow you to say this fraction of, 11 or this is the degree of foliar injury you'd 12 expect to get? 13 But if it's possible to do it 14 quantitatively, that is more informative than 15 these risk classes, so that's an alternative 16 to saying if it's possible to do it that way 17 then you don't need these, you know, somewhat 18 artificial high, medium and low. 19 I'm sorry if that was, I feel like 20 I was kind of rambling there. Does that make

21 sense? 22 DR. HUBBELL: No, I understand. I Page 315 1 just can't remember. We've had conversations 2 about the foliar damage data. We're hoping to 3 get the Forest Health Monitoring program and 4 we've talked about doing some analysis with 5 that using that data. 6 DR. SMITH: No, we're still 7 planning that. We are planning to look at 8 that and that might be something that would 9 help inform what you're talking about for this 10 and I would be very happy if it did. 11 DR. HUBBELL: And one thing that 12 comes up with that as you're probably well 13 aware is any time you do something like that 14 that's a new analysis. 15 It's essentially a research effort 16 and there's questions that come about about 17 what's the proper way to hit that, you know, 18 review in a way we can then use? 19 It's a delicate balance between 20 developing a risk analysis methodology and 21 developing a new concentration-response 22 function which we then use. Page 316 1 So we do have a balancing act 2 about how to introduce new information into

3 our assessments. 4 CHAIR SAMET: Okay, anything else? 5 I'm going to propose a break. You're past 6 time for a break here. So why don't we break 7 for 15 minutes. 8 (Whereupon, the above-entitled 9 matter went off the record at 3:03 p.m. and 10 resumed at 3:21 p.m.) 11 CHAIR SAMET: So are up to Chapter 12 6. And actually, Kathy, on Chapter 5, would 13 you be the summarizer for the comments? Okay,

14 thanks. 15 Chapter 6, Ecosystem Services.

16 Dave? 17 Dave, are you ready to -- you're 18 the first commenter on this, on Chapter 6.

19 DR. GRANTZ: I am? 20 CHAIR SAMET: You are, but you can 21 concede to Peter if you want. Would you like

22 to be last? Page 317

1 DR. GRANTZ: No, I just have one

2 real comment that I wanted to make. There's 3 a question, 15, I guess, how appropriate it is 4 to link things that are sort of secondary to 5 ozone. And in California that's bark beetles, 6 but there are other things. And I think 7 that's just very appropriate. 8 And I think to the extent that you 9 can tease out some sort of a fractional or 10 approximate fractional impact of ozone on 11 susceptibility to these other things, I think 12 that is just very appropriate. Now obviously 13 you're not going to have exact quantitative 14 numbers for that, but I do think we can make 15 some estimates given drought intensity and 16 ozone levels in different places that are 17 seeing bark beetle infestations, for example. 18 You can start to make at least qualitative 19 assessments of the risk that's associated with 20 having ozone as opposed to not having ozone. 21 So I think in that sense you're on the right 22 track, and so I support that strongly.202-234-4433 Neal R. Gross & Co., Inc. Page 318

1 CHAIR SAMET: That's it? 2 DR. GRANTZ: I think that's the 3 key point, yes. 4 CHAIR SAMET: Okay, Peter? 5 DR. WOODBURY: So I'm not going to 6 go through all the details, but there's a 7 question, 16B, about extrapolation of 8 concentration response, functions across 9 similar species. I think, yes, this can be 10 done but it needs to based on, you know, 11 physiological factors. And it looked to me, 12 if I understood correctly, in the FASOM 13 appendix that it may have done on kind of 14 economic groupings. So I think sugar beets 15 was in with sorghum and, you know, sugar cane 16 and some other sugar crops, if I read that 17 correctly. So the point would just be, it 18 needs to be done on a sort of physiological 19 basis. 20 DR. HUBBELL: If we could clarify 21 how we did it, because I'd like to be sure

22 that we -- Page 319

1 MR. ZHANG: Hi. My name is Yuquan 2 Zhang, who did the FASOM, just your modeling 3 for this ozone impacts work. That's a very 4 good question that why we use the proxy crops 5 and mapping them to the FASOM, just your 6 crops. Basically it's because the limited 7 data. And so in order to incorporate as much 8 information into FASOM model, we have to use 9 the crop mapping. And why we use sorghum to 10 sugar beets, those mapping are based on many 11 previous experiences of FASOM modeling when we 12 were doing the national assessment about 13 climate change. When we don't have 14 information for each crop we have to use some 15 crop mapping. 16 DR. HUBBELL: And were they mapped 17 based on physiological characteristics? 18 MR. ZHANG: Largely they are, 19 although just like you mentioned, I think that 20 mapping sugar beets for sorghum may not make 21 as much sense physiologically, but we can 22 reconsider that issue and then use a better Page 320 1 proxy. 2 DR. HUBBELL: One question for 3 you, Dr. Woodbury, is if there are particular 4 characteristics that you would recommend us to 5 match on would be very helpful.

6 DR. WOODBURY: Yes. I mean 7 there's plenty of literature on this. There 8 is clearly a difference between C3 and C4 9 species. You don't want to mix those together 10 under any circumstances, so that's why that 11 one jumped out to me. Again, let me just 12 emphasize the general point that it's not 13 appropriate to group them based on economics 14 or other criteria. You have to pay attention 15 to some, you know, physiological expectation 16 that there may be a similar ozone response. 17 So again, beyond the C3 and C4, I don't know 18 if any of my colleagues want to suggest any 19 other guidelines. 20 I mean I guess I would say with, 21 you know, perhaps this is just brainstorming, 22 but if you can come up with some physiological Page 321 1 groupings that do make sense and then look at 2 the data that you have for species within 3 those groupings, come up with sort of an 4 average response function among two or three 5 or four species in a group, you know, that 6 might be a defensible approach that would kind 7 of combine, using the data you have but paying 8 attention to the major differences in 9 physiology. 10 DR. HUBBELL: For tree species we 11 attempted to do this many years ago, like 12 five, six, seven years ago. We attempted to 13 do this based on photosynthesis rates and a 14 few other characteristics for trees, and then 15 we clustered them and tried to do that. They 16 did okay, but it was difficult to find the 17 kind strong patterns that we would have liked 18 to be able to support those groupings. So 19 again, this is helpful to get the information 20 you have, and we'll certainly try to find some 21 other characteristics. 22 MR. ZHANG: Thank you so much.202-234-4433 Neal R. Gross & Co., Inc. Page 322 1 DR. NEUFELD: I just wanted to 2 reiterate that. I mean you could do 3 functional traits, you know, and so things 4 like early versus late successional species. 5 Determinate versus indeterminate could be 6 really important, because a tree that's 7 indeterminate can keep replacing leaves that 8 are injured by ozone with new leaves and 9 perhaps not be as sensitive, whereas, a 10 determinate tree, those leaves are going to be 11 out there all the time and that's the only 12 leaves it produces. It's not going to have 13 the capacity say to do that. But you still

14 have to careful. 15 For example, the example I gave in 16 my comments here is black cherry and pin 17 cherry. I mean just from those of us who look 18 in the field, pin cherry appears to be less 19 sensitive to ozone, and that's anecdotally 20 now, but there is one study that's shown, than 21 black cherry and yet they're very closely 22 related and they're both really successional Page 323 1 so you --

2 DR. HUBBELL: Do we understand 3 from the science of why they're different in 4 terms of their --

5 DR. NEUFELD: No. 6 DR. HUBBELL: No, okay. 7 DR. GRANTZ: And just to throw 8 another thing into that. We've shown that 9 there's as much variability among C4 species 10 as there is between C3 and C4 species. Sugar 11 cane is absolutely quite sensitive, some 12 varieties, to ozone. So it's very difficult 13 to do that. I think functional types may be 14 a good point, and also growth habitats may be 15 a good point. And from that sense, sorghum 16 and sugar beet at least some cultivars, might 17 be a fairly good substitution from 18 California's desert areas. 19 CHAIR SAMET: Okay. So let's see.

20 Peter? 21 DR. WOODBURY: I guess just to 22 briefly say there is a question, 16, in Page 324 1 general about forest yield impacts. And just 2 to clarify my earlier point, I do think it's 3 important to try to look, you know, I 4 appreciate the effort to look at as many tree 5 species as possible and to find a way to 6 aggregate up, so I'm not suggesting, 7 necessarily, that you need to employ a really 8 complex, unwieldy modeling strategy, but you 9 may consider if there are serious issues with 10 integrating multiple species into an analysis 11 I just want to, I guess I'm just asking to 12 account for that in the approach. 13 So for example, if you're looking 14 at net primary production as an endpoint you 15 want to account for this competition among 16 species in some way, and starting in the 17 conceptual model there. And, you know, it may 18 be with some of the limitations about 19 importance values, et cetera, you know, you 20 may want to look at analyses of individual 21 species, you know, for areas where they're 22 relatively important, not necessarily Page 325

1 combining the multiple species together in the 2 same analysis, but looking at some common 3 sensitive species individually and then 4 aggregating those results by region or 5 something. 6 There was a question, 18, about 7 PnET-CN, use of that model. So, you know, and 8 any model represents some processes and not 9 others, and my understanding of PnET is that 10 it's what's called a "big leaf" model so that 11 canopy's kind of model it as one giant leaf. 12 And I don't know in that context how you 13 account for this issue of competition between 14 ozone sensitive and less sensitive species. 15 So again, just make sure you're considering 16 that issue in using a model like that. 17 Again for forests that are 18 dominated by a particular species it's not an 19 issue, so that might be a domain where that 20 would appropriate. And again with PnET-CN, 21 just paying attention to this issue of scaling 22 from seedling data to a mature tree or, you202-234-4433 Neal R. Gross & Co., Inc. Page 326 1 know, the other approach is kind of scaling 2 based on a photosynthetic response and maybe 3 modified with stomatal conductance, you know, 4 to the mature tree. But again just making 5 sure you're looking at those issues as you do 6 the analysis. I think that's it. 7 CHAIR SAMET: Okay, thanks. 8 Kathy? 9 DR. WEATHERS: I'd just add to the 10 comment about PnET is I think it's an 11 interesting idea to try to run that model but 12 being clear about what it is that you're 13 looking for and what the model might tell you, 14 which is probably about what you don't know, 15 is important up front. And I question whether 16 you have all of the data you need to 17 parameterize the model across the country. 18 You might consider DayCent-Chem. 19 I don't know if you can get your hands on that 20 model or work with the folks who developed it21 at Colorado State, but that's another bio22 geochemical model that could give you the same Page 327 1 kinds of output that was parameterized with 2 CENTURY, so some flexibility. 3 DR. WOODBURY: Sorry. One other 4 point I forgot to mention related to the PnET 5 model is to be, you know, with this model and 6 any other ones there's going to be a couple of 7 key relationships or factors that kind of 8 drive the results, right, even if the model's 9 relatively complex. So for the tree-grow 10 model it's going to be, how is the 11 photosynthetic response to ozone represented? 12 So that's essentially parameterizing the 13 model. It's a big complicated model, but if 14 you're looking at multiple species and the 15 differences between them, that's what's going 16 to drive the difference. 17 And with PnEt, if you're looking 18 at hydrologic responses then the critical 19 assumption is going to be, or parameterization 20 will be, what is the effect of ozone on 21 stomatal conductance? And the literature on 22 this topic is unfortunately complex. My Page 328 1 colleagues may have some more clarity than I 2 do, but sometimes stomata close, sometimes 3 they open, sometimes they don't seem to 4 function very well. 5 I guess I would recommend focusing 6 on Sandy McLaughlin's study and other studies 7 of mature trees to the extent, you know, Nancy 8 Grulke's as well, in California, and any other 9 studies of mature trees so that you hopefully 10 can represent that. This is also an example 11 of the kind of key assumption that I would 12 like to see represented in the risk analysis. 13 Again you can't put everything about the model 14 and you don't need to, but sort of those key 15 relationships and what assumption was made, I 16 think, is important. 17 CHAIR SAMET: Okay. 18 DR. HUBBELL: Can I ask, for Dr. 19 Weathers, do you have a primary reference for 20 that DayCent-Chem model? I don't think that

21 we've evaluated that.

22 DR. WEATHERS: There's several. I Page 329 1 think the most recent one might be in the USGS 2 peer review report, which is Hartman, et. al., 3 H-A-R-T-M-A-N, and Jill Baron also. I think 4 there's a Baron, et. al. 5 CHAIR SAMET: So actually to bring 6 them to their attention, put them in specific 7 references into your comments.

8 DR. WEATHERS: Yes. 9 CHAIR SAMET: Thank you. 10 DR. WOODBURY: Kathy, do you know 11 if they've been used that they represent ozone 12 response at all? 13 DR. WEATHERS: I don't think they 14 have historically, but it's a fairly detailed 15 biogeochemical model that might be able to set 16 ozone. Other insults to trees, but I don't 17 think ozone. 18 DR. WOODBURY: But that may be 19 getting more into a research model than -- 20 DR. WEATHERS: It may be. 21 DR. WOODBURY: -- applying an 22 existing model that has parameters for ozone.202-234-4433 Neal R. Gross & Co., Inc. Page 330 1 CHAIR SAMET: Okay. Howie, you're

2 the last to comment here. 3 DR. NEUFELD: Okay. Well, I agree 4 with what's been said before. I wanted to go 5 back to the i-Tree model. I was talking to 6 somebody at a meeting a couple months ago, 7 because we were doing some urban forestry 8 stuff, and about the model, and he said it was 9 developed for southern trees. 10 Am I wrong or has it been 11 parameterized, because you guys are using it 12 all over the country. He was a little worried 13 about us even using it up at Appalachian State 14 at Boone. So I was wondering if you could

15 comment on that. 16 MS. DAVIS: Hi. I'm Christine17 Davis. I'm responsible for Chapter 6. The i18 Tree model, our understanding from working 19 with Dave Nowak at the Forest Service, is that 20 they have used it and parameterized it for 21 many cities across the country and even across 22 the globe, so that it shouldn't be an issue Page 331 1 having it parameterized. They go out and 2 actually have field measurement data for the 3 forests in the particular cities. 4 DR. NEUFELD: Okay. 5 DR. HUBBELL: In fact, one of the 6 sort of unique things about the i-Tree model 7 is that it's using, you know, inventories, 8 urban inventories of trees so it's fairly 9 well, that level of uncertainty about what 10 trees are actually there is much lower than in 11 some of the other types of assessments. 12 DR. NEUFELD: We were just talking 13 to some people from the Southern Forest 14 Experiment Station and they expressed that 15 concern. That's why I brought it up. But if 16 you've got it all taken care of, that's great. 17 DR. HUBBELL: Thank you. 18 DR. SMITH: Part of the selections 19 for that was in working with the Forest 20 Services we gave them species that we had 21 response functions for and they went through 22 the cities that they do have parameterized and Page 332 1 said, here's some cities that we can actually 2 do something with. And so that was a part of 3 the question, is they had the list of what 4 they could do. 5 DR. NEUFELD: I also think it's 6 very good that you are doing the urban 7 forests. I think that's a really important 8 thing to keep track of because it's important 9 both to people in the cities, and they do make 10 up a pretty substantial number of trees across 11 the country. 12 I had the same questions about 13 PnET because it was originally developed, you 14 know, in the Harvard Forest at Hubbard Brook. 15 About, you know, the big leaf 16 model, I'll just give you an example. Art 17 Chappelka's work showed that when he was doing 18 the analysis of full-year injury of trees in 19 the Smokies, it wasn't the leaves that were at 20 the top of the canopy that were the most 21 injured. It was the ones about a meter down 22 in the canopy that had the most full-year Page 333 1 injury from ozone probably because they were 2 less water-stressed. You know, the direction 3 radiation hitting the top of the canopy 4 actually caused the stomata in those leaves to 5 close and they took up less ozone. So there 6 actually was more injury lower down in the 7 canopy, and there's less light there. 8 So I think, you know, assuming 9 it's just a single leaf it's going to miss 10 some stuff and, you know, in terms of how a 11 tree is, and it's very complicated, I mean 12 trying to do a whole canopy, so you have to 13 make some compromise. But just so you know 14 that there's that potential variation going

15 on. 16 And you made the comment, I know 17 we brought it up last time about using this 18 model that Hanqin Tian's using at Auburn, the 19 DLEM, and you sort of said in there, well, we 20 can't use it, but you didn't say why. Could 21 you elaborate on that? I'm just curious. 22 DR. SMITH: So we met with Tian at202-234-4433 Neal R. Gross & Co., Inc. Page 334 1 ESA in Austin, a couple of us met with him, 2 and it is a proprietary model. And a lot of 3 it is, you know, we just didn't have the 4 resources to be able to utilize his model. So 5 it's not something, it was just we were 6 resource-limited on the ability to access the

7 model. 8 DR. NEUFELD: And the other thing 9 I want to talk about, and this gets into maybe 10 some little controversy stuff here, is it says 11 here in Question 19, regarding ecosystem 12 services related to full-year injury. What do 13 you think about using potential full-year 14 injury as a metric to a sense potential lack 15 of cultural services. 16 Well, having worked in the Smokies 17 on one of the most well-traveled paths, the 18 path up to Clingmans Dome, I would have to say 19 except for one person that I met, Lyle Craker, 20 once, who came up to me. I didn't know that 21 he was an ozone researcher. He was the only 22 person I met in three years that even thought Page 335 1 about ozone and knew what was going on with 2 the plants there. 3 So is there perhaps a better way 4 to get at this? I think if people are pointed 5 out, if it's pointed out to them that these 6 plants that have all these brown leaves, and 7 indeed, it looked like somebody had walked 8 along the trail with a flamethrower when we 9 had the high ozone in the late '90s, but 10 people just thought that was natural. But if 11 you pointed out that that was due to ozone 12 they were very concerned. So perhaps there's 13 some other metric one can get at. But I don't 14 think the average person walking down a path 15 will know or see ozone injury, and on the 16 trees especially because it's way up in the 17 canopy. 18 DR. HUBBELL: So based on what you 19 just said, the question is, are you saying 20 that people didn't notice that there was 21 something wrong, or wouldn't have noticed if 22 it was better, or is it that they, if they Page 336

1 didn't know that it was from ozone? Because 2 if they still saw that it was damaged and 3 thought like, gosh, it would have been nice if 4 that was green instead of brown, then that

5 matters. 6 DR. SMITH: Right. They did not 7 know. Some of them would comment, you know, 8 why are these plants brown? And then we would 9 tell them it was ozone injury, air pollution, 10 okay, and then they were concerned. But 11 others, most people just didn't even notice 12 it. And with trees, you know, where you have 13 to really train yourself to see what foliar 14 injury looks like, most people would not 15 notice the injury on the leaves. 16 So I'm thinking perhaps there's 17 some other way, I mean of assessing the 18 cultural impact to people either through 19 sociological surveys. You know, the EPA 20 queried people in terms of how much a life is 21 worth, you know, doing the cost-benefit 22 analysis by asking how much would they Page 337

1 sacrifice from their salary in order to make 2 the workplace safer to prevent one fatality. 3 So one could do a similar thing with, you 4 know, people, in saying if they were told it 5 was ozone injury, how much is it worth to 6 them? And then you could try to monetize that 7 and get a risk to the things like that. 8 CHAIR SAMET: Okay, any other 9 comments? Howie, you're not -- okay. 10 Comments from others on Chapter 6 Ecosystem 11 Services?

12 Steve? 13 DR. KLEEBERGER: I've got more of 14 a point of interest than a question. But this 15 discussion on Chapters 5 and 6 have sort of 16 brought out my old ecology background. And 17 I'm curious whether there are secondary 18 effects of ozone exposure on plants that would 19 impact animal biomass or animal diversity or 20 energy flow or nutrient cycling. I mean have 21 studies been done that could be incorporated 22 into this modeling, or perhaps you've already202-234-4433 Neal R. Gross & Co., Inc. Page 338

1 done that. I have to admit I haven't read 2 either one of those chapters yet. 3 DR. SMITH: I don't know, right 4 off, of any studies that have carried it that 5 far through. I think in a, paren, 6 theoretical, ecological view, I would say of 7 course there must be some effect, but we would 8 have absolutely no way to quantify that beyond 9 saying this might be an effect. DR. NEUFELD: 10 Well, let me give you an example. It's a 11 recent paper by people down at Auburn looking 12 at effects of ozone on digestibility of 13 forage. So the Southeast, for example, and 14 just to tell you impact, the Southeast has 15 about 18 million hectares of pasture land, 16 managed pasture land, so they were looking at 17 this as, and used rabbits, which are the main 18 herbivore, and without any foliar symptoms 19 there were decreases, significant decreases in 20 digestibility. 21 So, you know, there's a trophic 22 interaction kind of thing there and people Page 339 1 have done other things with insects and that's 2 been covered in the ISA and so on. And that's 3 why I think, you wrote in the Ecosystem 4 Services of disruption of biogeochemical 5 cycling, so there's some empirical data to 6 support those. 7 CHAIR SAMET: Okay. Other 8 questions? 9 Dave, would you take on the 10 summarizer role of this?

11 DR. GRANTZ: For? 12 CHAIR SAMET: Chapter 6. 13 Chapter 7. Howie? 14 DR. NEUFELD: I thought the 15 synthesis was well done. I didn't really have 16 too many comments here. The only thing I have 17 is a little question, is that there is a 18 bullet explaining biomass losses in the 19 Smokies, which suggests that the response is 20 quite large, and yet when you go back to the 21 Kohut assessments then the risk to the Park is 22 low. So there's a contradiction there and I Page 340 1 was wondering, how can you reconcile that? 2 DR. SMITH: With The Great 3 Smokies, you can come up with a couple of 4 contradictions of that. One is that the Kohut 5 study is foliar injury compared to biomass 6 loss, which we didn't try to do anything to 7 compare those two, really, in this. And the 8 Smokies actually were slightly different when 9 we looked in the context of the Class I areas 10 compared to when we looked at it at the finer 11 resolution of the Park map. And so just even 12 the resolution of that changed the results 13 slightly in the Great Smoky Mountains when we 14 used the Park mapping data versus just the 15 larger scale FIA data that I had available. 16 And so I think the contradiction you're 17 talking to is because it's the difference of 18 the foliar injury versus biomass loss. But 19 there was a slight difference between just 20 looking at on the fine scale versus the bigger

21 scale. 22 CHAIR SAMET: Okay, Kathy? Page 341

1 DR. WEATHERS: Yes, I also thought 2 it was useful and it made me wonder whether it 3 ought to go up front. I was a little sorry to 4 see it at the end of the section rather than 5 up front. So I thought it was well done. And 6 the only question I had, whether the reference 7 points of no ozone was reasonable and 8 defensible and we've already been there. 9 CHAIR SAMET: I will say the 10 headings and title match what we saw in the 11 human health and exposure risk assessment, 12 where the title of the chapter was synthesis, 13 but it was actually not synthetic but more of 14 a summary. And I think this same issue we 15 brought up there, I guess, I don't think you 16 were here but, might not pertain here, which 17 is, are you going to write a synthesis here at 18 the end and provide the executive summary at 19 the beginning? I mean recognizing this is a 20 work in progress. 21 DR. HUBBELL: Yes. The plan is to 22 do the executive summary and to make the next202-234-4433 Neal R. Gross & Co., Inc. Page 342 1 draft have a more comprehensive synthesis. 2 And if you all are interested, we can also try 3 to make sure that each of the chapters has a 4 summary as we're doing in the health chapter, 5 summary results, and that way you have a 6 consistent process.

7 CHAIR SAMET: Yes. I mean I 8 really think they should be parallel including 9 the comments earlier about showing what has 10 come from the ISA, what's based on prior

11 assessments and so on. 12 Howie?

13 DR. NEUFELD: Can I make one other 14 just structural comment since we're kind of 15 talking about it? It goes across both welfare 16 documents. And that's the large amount of 17 material that is redundant from the ISA, so it

18 adds bulk to both documents. 19 Is it because you have to have 20 these as stand-alone, assuming somebody didn't 21 read the ISA, or could you shorten those 22 sections? You know, where you come up to Page 343 1 where you're justifying the risk analysis, 2 it's almost like completely redoing a 3 literature or science review and then saying 4 what you're going to do. Is there any way of 5 shortening that and sort of just referring 6 back to the ISA so that you get, and what it 7 would do is it would focus your attention more 8 on the risk assessment in these documents as 9 opposed to reading through all the, like a 10 literature review almost.

11 DR. HUBBELL: It's a constant 12 struggle, and we look to you all to decide 13 what's the most appropriate way to move this 14 forward. Because generally when we've tried 15 to cut it down a lot then some people pick it 16 up and go, well, I haven't read the ISA and I 17 don't want to go back and read the ISA. And 18 so it's a struggle to know how much material 19 to carry forward from document to document. 20 You'll see this obviously in the 21 policy assessment as well. There's some 22 duplication of both documents. And it's Page 344 1 really a question for you, the panel, to give 2 us advice on, you know, what do you think is 3 appropriate to carry forward to allow you and 4 the public to give advice and good comment?

5 CHAIR SAMET: Fred? 6 DR. MILLER: Well, I view that 7 they ought to be stand-alone documents, but I 8 also view that it's like a cone, and the ISA 9 is the base of the cone and the PA is the tip 10 of the cone. And the amount that you can cut 11 down between the REA and the PA is probably 12 much greater than you can cut down between the 13 ISA and the HREA, or the welfare part. And I 14 think there are a lot of people who only read

15 one of these three documents. 16 And so we're getting subjected to 17 all of it and we think that it's too much, but 18 for somebody who didn't wade through the 1,177 19 pages of the ISA, which I want to congratulate 20 the agency. That is about half of what it was 21 ten years ago. So I think that you have to 22 consider a little more rather than less, but Page 345 1 paring down as you go. That's my opinion. 2 CHAIR SAMET: You know, I think if 3 you wrote this in a way that it was very clear 4 what you were bringing from document to 5 document up front, and then had some 6 supporting material perhaps, doing what Fred 7 said, so those who have not read the ISA, 8 here's the brief version. So it was very 9 clear what you brought forward so you didn't 10 have to struggle to find it in the midst of a 11 mini-ISA, which I think is what many of us 12 have sort of objected to as we've read the 13 documents. Because in part this sort of 14 cutting and pasting and pulling forward 15 doesn't really work. I think it's hard to 16 write a good synthesis or a good summary. 17 And so I think that what you could 18 do is say, look, here's what I brought forward 19 from the ISA. Here is a brief summary of 20 relevant aspects not only the most critical, 21 and move on. Something like that would be my 22 preference. I mean I think Fred is right202-234-4433 Neal R. Gross & Co., Inc. Page 346 1 about one thing. The documents certainly 2 should get shorter as you go from the ISA at 3 the base to the subsequent documents. Those 4 who want to comment on this?

5 Pete? 6 DR. WOODBURY: Yes, just briefly. 7 I agree that this is going to be an ongoing 8 tension. There's never going to be a perfect 9 resolution, but I am in favor of the risk 10 assessments, you know, being stand-alone 11 documents with reference to the ISA. 12 And I guess, you know, we're 13 talking about what's the definition of a 14 stand-alone document. Maybe what will help is 15 clearer sign posting. You certainly don't 16 want to summarize the ISA in the risk 17 assessment. It's really, to my view, the risk 18 assessment is focusing on some key 19 relationships and performing some analyses, 20 and you need just to reference the material 21 that directly supports those. And then to the 22 extent that you're going to have a qualitative Page 347 1 discussion of other end points that maybe 2 can't be quantified, you know, you need a very 3 brief, few sentence support for why those

4 matter. 5 So I guess maybe as a model, when 6 I look at a journal article I like to see a 7 value claim, preferably in the abstract,8 certainly in the introduction. And a well9 written introduction to a journal article 10 quickly gets you from the general literature 11 to, why am I reading this article and what's 12 the point? 13 CHAIR SAMET: Okay, anything else 14 on this point? 15 Okay. So let's see. Howie, would 16 you summarize the comments on Chapter 7? I 17 don't think there's much to summarize at this 18 point. 19 So let me see if there's anything 20 else on this document and then I'll make a 21 suggestion as to what we might do. 22 Ted, what time are you leaving? Page 348

1 DR. RUSSELL: 4:45. 2 CHAIR SAMET: 4:45. Anybody else 3 leaving before 5:00?

4 Peter? 5 DR. WOODBURY: I just have one

6 more. 7 CHAIR SAMET: And you want to

8 leave? 9 DR. WOODBURY: No, not leaving. 10 Just on the synthesis, I think that's where it 11 was mentioned that you do plan to look at the 12 forest health monitoring data, and I just want 13 to say I do think as we've heard previously 14 those are really important useful data. I 15 would like to encourage you also to look back 16 at the approach that was used in the previous 17 round of looking at the forestry health 18 monitoring data by, you know, I think it was 19 CMAC grid cells. Jeff can correct me from

20 here. 21 MR. HERRICK: Those were counties. 22 DR. WOODBURY: A County scale, Page 349 1 thanks. So I thought that was a useful 2 analysis and it might be useful to refresh 3 that analysis. It did give a good coverage of 4 much of the country. 5 CHAIR SAMET: So what I'm going to 6 suggest, I think that our discussion on this 7 document seems to be over, and that we now 8 move to the clarifying comments from the 9 public. Here, we have three commenters. And 10 then just return back, I think, to sort of 11 perhaps I'll say our last discussion on the 12 policy related background, et cetera, 13 discussion while we have Greg here. 14 So let me ask, we have three 15 commenters. We've allocated for each of you 16 three minutes to present. And again we, I 17 guess, heard from you before, so what we'd 18 like is your comments that are clarifying or 19 additional based on your attendance here at 20 the meeting or related back to clarifying 21 earlier comments. So let's see, I think are 22 we almost ready. And I think Angela will give202-234-4433 Neal R. Gross & Co., Inc. Page 350 1 you a warning at -- 2 DR. NUGENT: I'll give them 3 warning when two of your three minutes are

4 over. 5 CHAIR SAMET: Okay, so our first 6 commenter is Sonja Sax, on behalf of the 7 American Petroleum Institute. 8 DR. NUGENT: And I believe she has 9 given Greg a slide with this. 10 MS. SAX: Hi again. Thank you 11 again for the opportunity to clarify some of 12 the comments. First of all, I just want to 13 follow up on the general BenMAP approach and 14 this issue of confidence intervals. 15 Specifically, I was referring to the 16 confidence intervals in the deltas, which were 17 not in the first draft, and the importance of

18 those. 19 Also I just want to show two 20 figures that I think are informative. These 21 are some BenMAP analyses that we conducted. 22 They're not using exactly the same data that Page 351 1 EPA used, but they do show the estimates down 2 to zero and LML and PRB. And it's a little 3 bit difficult to see the graph, but 4 essentially on the Y axis you have the 5 different concentration response functions 6 that we applied from Smith 2009 summer, the 7 EPA's Zanobetti and Schwartz, the EPA Bell and 8 the all-year Smith, et al., 2009 concentration 9 response functions. The closed circles and 10 triangles and squares are the current 11 conditions, and the rollback conditions are 12 the open circle, triangle and square. And 13 this is basically showing zero, LML and PRB. 14 And what I want to note here is 15 just the confidence bounds. They're really 16 large, so in reality whether you're 17 considering zero, LML or PRB, you know, this 18 really shows that a zero risk can't be ruled 19 out based on the confidence intervals. 20 Another important point in taking 21 the approach of going down to zero or LML, 22 this could really be interpreted as, you know, Page 352 1 these are kind of alternative ozone levels, 2 and I'm not sure we really want to go there. 3 And based on the uncertainty, you know, it may 4 be this is not the best approach. Also we 5 should note that not all of the uncertainty is 6 in these confidence bounds. Next slide, 7 please. 8 I think it's more appropriate to 9 really try to focus on the deltas, and this is 10 what I have plotted here. Oh, I guess my 11 first, it's hard to tell but there's another 12 column that's very light, I guess, and you 13 can't really see it, but that's the zero 14 level. But essentially, when you're looking 15 at the deltas there's very little difference 16 between the zero, LML, and the PRB. And again 17 there's some differences depending on the 18 concentration response function that you use, 19 but there's no confidence bounds here. So 20 without the confidence bounds we can't really 21 see whether these differences are 22 statistically significant or not. So those Page 353 1 are my two points. Thank you. 2 CHAIR SAMET: Okay, thank you. 3 Any questions? Okay, thank you. 4 Our next presenter is Chris Emery,

5 on behalf of ENVIRON. 6 MR. EMERY: My comments at this 7 point are more about HDDM. There seems to 8 have been confusion among the community 9 members about how HDDM is going to be used in 10 the health risks and welfare REAs, and the 11 details in each of those documents. And 12 apparently not everyone has seen the Simon 13 memo. So Heather Simons got most of the 14 details in there, but still it's kind of 15 lacking because they're still developing some 16 details. 17 But I just want to reiterate, it's 18 going to be important to run a whole year 19 mainly for several reasons that Heather has 20 already talked about. Mainly, a lot of areas, 21 their ozone season does go over the entire 22 year, and if you're going to use the same run,202-234-4433 Neal R. Gross & Co., Inc. Page 354 1 which I would expect EPA to do to deal with 2 the scaling for the fused national assessment, 3 then you would want to do a whole year. It 4 adds of course more data points for the entire 5 year so that, you know, more relationships 6 over the entire year can be developed using 7 HDDM. So more data is good. 8 Also you can get background from 9 the HDDM run, if you just push zero omissions 10 through the sensitivity results you do get a 11 background number. In this case, I believe 12 that the EPA is running U.S. background in 13 their HDDM run. Or you can do zero out. But 14 given apparent schedule constraints, I think 15 that you can actually get out of this one run, 16 the U.S. background. And that will be good to 17 push that through APEX as a background, and 18 push through, for example, a 75 ppb standard 19 rollback so that you can quantify the change 20 in risk. It seems like it would be fairly 21 straightforward to do from one HDDM run for 22 the whole country for a whole year. Page 355

1 The other thing is, it seems like 2 there's a lot of concern about really knowing 3 what the HDDM approach is well before the next 4 draft of the REA comes out, and this is kind 5 of important. So would it be possible, just 6 as a suggestion, for EPA to come out with an 7 interim technical memo on kind of the final or 8 at least semi-final details of how the HDDM is 9 being applied for both the health and the 10 welfare risk assessment? Apparently the next 11 draft is going to be coming out in late 12 winter, maybe even early spring, and so it 13 would be good to have -- 14 DR. NUGENT: Dr. Emery, one 15 minute. 16 DR. EMERY: Thank you. It would 17 be good to have kind of a CASAC ability, even 18 a public review capacity of some sort of 19 interim technical memo coming from the EPA 20 modeling staff, so that we have a good handle 21 on what's going on with HDDM well before the

22 REA comes out. I know that's another round of Page 356 1 review, but it would answer a lot of questions 2 well before the REA comes out, and maybe some 3 of the modeling experts on the committee could 4 benefit from that. 5 Okay, that's all I have. 6 CHAIR SAMET: Okay, thank you. I 7 don't know if anyone from EPA wants to comment 8 on interim technical memos, but -- 9 Why don't you come up to the 10 microphone? 11 DR. HUBBELL: So obviously given 12 the schedule that we showed to you the other 13 day that that's highly infeasible to develop 14 a separate technical document that would then 15 be released as a public document for comment, 16 et cetera. Clearly, we want to be able to 17 provide as much information as possible and, 18 you know, we'll be releasing the document well 19 advance of the CASAC meeting, at which time 20 the public can comment on that as well, just 21 like we did this last time. 22 We tried very hard to provide as Page 357

1 much technical information as we could in this 2 go-around for a very complex, new modeling 3 effort and we'll continue to try to provide 4 that information, but I don't see it being 5 feasible to try to produce an interim document 6 within the schedule we provided earlier. 7 CHAIR SAMET: Okay. All right, 8 fine.

9 Fred? 10 DR. MILLER: Is it required that 11 this HDMA or MEA or -- it's getting late -- be 12 in the ISA? Where does it have to appear that 13 the agency can use this on a go-forward? 14 We've talked about some other manuscripts that 15 clearly need to be added to the ISA. Is this 16 another category, and maybe there's not a 17 publication, but I'm wanting to make sure that 18 it doesn't drop through the crack as to where 19 it has to be referenced such that it can go

20 forward. And I don't know the answer. I'm 21 asking. 22 CHAIR SAMET: Well, others may202-234-4433 Neal R. Gross & Co., Inc. Page 358 1 want to comment. I think ideally, presumably, 2 the model would have been presented and 3 reviewed in the ISA and commented on. 4 DR. HUBBELL: Yes, we haven't sat 5 down and talked with our colleagues who are 6 working on the ISA about HDDM specifically. 7 Clearly we will need to do so. 8 You know, one other point I want 9 to make is that we are preparing a draft for 10 submittal to a journal on this initial HDDM 11 effort, the evaluation and the case studies. 12 Hopefully it will get into the literature 13 prior to when we have to finalize the REA. 14 But in terms of having this 15 specific methodology and this specific 16 application in the ISA, I don't think that 17 that's going to be possible given the time 18 frame, but the methodology itself, the HDDM 19 methodology, there are articles and literature 20 already on that approach that can be 21 incorporated into the ISA. 22 MS. WEGMAN: And we do plan to Page 359

1 talk to John and his folks about that. 2 CHAIR SAMET: Okay, yes? 3 DR. JACOB: I had a question for 4 Chris. So using HDDM to try to get the 5 background, wouldn't that cause an arch 6 overestimate of the background because of the 7 non-linear depends on ozone on emissions? 8 CHAIR SAMET: Go ahead and please 9 come to the microphone. 10 DR. JACOB: I think it's suggested 11 that we could use the HDDM to infer the 12 background emissions. And I'm wondering if 13 that would lead to a great overestimate of the 14 background because of the non-linear 15 dependence of ozone on its precursor 16 emissions. 17 DR. NOVAK: Well, it depends on 18 how you run HDDM. But the way I understand 19 EPA's approach where they actually have to run 20 it three times, effectively, in order to get 21 the full NOx effect, the non-linear NOx 22 effect, that helps to replicate the U.S. Page 360 1 background really closely relative to a zero 2 outrun. So the non-linearity of the HDDM is 3 taken care of, and so it should be very 4 similar to an actual zero outrun. 5 DR. RUSSELL: Though I would say I 6 mean, and you would know more about this than, 7 I think, anyone in the room is that what it 8 will miss when you do that is essentially the 9 global transport and impact, essentially, upon 10 the U.S. on itself after you, you know, it's 11 gone around the world.

12 DR. JACOB: Both the U.S. and 13 itself. 14 DR. RUSSELL: Yes, so it'll miss 15 that but it should be capturing most 16 everything else. And if they wanted to they 17 could use GEOS-Chem boundary conditions taken 18 from a U.S., removing the U.S. boundaries and 19 then they'd get it. 20 DR. NOVAK: I mean that's a good 21 point, and I don't know how much the U.S. 22 effects itself, but I think EPA, and we have Page 361 1 in our HDDM modeling has compared the HDDM 2 zero omissions case to a zero outrun, an 3 actual physical run. And for cases where 4 you're not super NOx sensitive, the 5 agreement's very good for a single HDDM run, 6 run at one particular case. 7 In EPA's situation where they run 8 three different HDDM runs to get the full 9 range from zero all the way down to zero 10 percent emissions, at least for U.S., I think 11 that that's doing a much better job at 12 replicating the U.S. background. So I think 13 it's probably a good way to get a lot of these 14 answers out with just one, you know, set of

15 HDDM runs.

16 CHAIR SAMET: Fred? 17 DR. MILLER: While you're up here, 18 can you comment on whether or not there would 19 be more reliability or less uncertainty if you 20 used North America background versus U.S. 21 background, or the pros and cons of how this 22 particular model could be influenced by which202-234-4433 Neal R. Gross & Co., Inc. Page 362 1 of these data sets that you might try to 2 generate? 3 DR. NOVAK: Well, I think that's 4 kind of a policy issue. You know, it's what's 5 going to be controllable. 6 DR. MILLER: That might be a 7 policy issue, but you obviously had a hell of 8 a lot of experience with the model. So I'm 9 asking you, for different data inputs what are 10 some of the things that provide the more 11 severability in the likely outcomes and stuff 12 like that, that might enter into deliberations 13 about which of these to pick? 14 DR. NOVAK: I mean you can run 15 HDDM either way. In our situation we're 16 running U.S. background. I'm not exactly sure 17 how the sensitivity output would respond 18 necessarily to a difference between NAB or 19 U.S. background. 20 DR. RUSSELL: The sensitivity 21 coefficients will be remarkably insensitive to 22 that except toward the boundaries. And just Page 363 1 remember that the starting sensitivities are 2 your base case so that's going to be the same, 3 and so then you just go with some emission 4 changes. So you'll have some impact at the 5 boundary but the internal sensitivities -- 6 CHAIR SAMET: So I think we need 7 to hear from our last commenter, and then we 8 will coming back to this issue. So thank you. 9 Our last commenter is Nicole 10 Downey on behalf of Earth Systems Science. 11 DR. CHOCK: Jon, can I make a --

12 CHAIR SAMET: Sure. 13 DR. CHOCK: I think Fred raised 14 the issue about incorporating HDDM into ISA. 15 I personally see in that because it is really 16 a mathematical theory other than a scientific 17 law or a model. So is similar to a quadratic 18 rollback is the mathematical tool even though 19 it's not science-based, and we don't include 20 that in our ISA. So HDDM is another 21 mathematical tool even though it's a lot more 22 vigorous. Page 364 1 CHAIR SAMET: Okay, thank you. 2 DR. BRAIN: And I have a quick 3 comment to Sonja, since we're looking backward 4 and reflecting. 5 Sonja, the first slide you showed 6 us, you know, you emphasized that here were 7 eight or ten studies and all of them had 8 confidence intervals which overlap zero. But 9 it seems to me, what about the point that 10 every single one, the average was to the 11 right? So even the Wilcoxon signed test would 12 say, you know, the chances of having eight or 13 ten all of the same sign are very, very low. 14 So I would interpret that slide very 15 differently. Yes, any individual study showed 16 a confidence interval overlapping with zero, 17 but they all showed a positive effect, all of 18 them. So a typical meta-analysis would have 19 drawn some strength from that. 20 CHAIR SAMET: Okay, so please go

21 ahead. 22 DR. DOWNEY: I have one slide. Page 365 1 I'm just going to talk about data so we'll 2 have to wait for the slide. 3 Okay, so as Chris talked about, ENVIRON 4 has done a one-year HDDM run for the U.S. 5 background case, and so this is very 6 preliminary. Just last week I made these 7 figures, compared the output of an HDDM run to 8 the quadratic rollback, and I just wanted to 9 show you some very preliminary results about 10 what the differences in the distribution looks 11 like because I think it's very interesting. 12 The way that this run was set up 13 is our run has 50 percent NOx and VOCs as a 14 starting point so that we could extrapolate 15 from both sides of 50. And in my case, when 16 I was trying to meet a proposed standard I 17 varied NOx and VOCs together. I just did NOx 18 and VOCs together the same amount. 19 So on the left I've got a couple 20 of figures from Riverside, California, in the 21 LA Basin. This is one of the sort of 22 controlling sites for LA. And the green bars,202-234-4433 Neal R. Gross & Co., Inc. Page 366 1 which are here, are the 2006 observations, and 2 then the red bars are the quadratic rollback.

3 And then the blue bars show what 4 the HDDM distribution looks like, and I think 5 from this figure you can really see that the 6 HDDM shows a significant shift upward in the 7 lower concentration bends, reflecting this 8 non-linear chemistry of ozone, which is very 9 different from the rollback, which pushes down 10 higher levels and really pins the bottom. 11 And so it reflects much more 12 accurately the atmospheric chemistry that's 13 going on and it's very different. And I think 14 this is going to have some implications for

15 both the health and the welfare assessment 16 because it also changes the seasonal cycle in 17 sort of the same way. You have a different 18 amplitude. And I imagine there will be some 19 diurnal changes as well. 20 DR. NUGENT: One minute. 21 DR. DOWNEY: And I think another 22 important point to note is that yesterday it Page 367 1 was talked about that someone mentioned, 2 ideally, you want to shift the whole ozone 3 distribution down when you change a standard. 4 And because of the non-linearity in ozone 5 chemistry, when you change emissions that 6 doesn't necessarily happen. 7 And what you end up with is 8 something that's much more peaky. And this is 9 getting Riverside down to 80 ppb is standard, 10 you see HDDM starts piling things up in the 11 middle because that's more reflective of how 12 the chemistry will respond. 13 And I think when you convolve that 14 with the concentration response functions and 15 look at these heat maps, you'll see some very 16 interesting patterns emerge. But this is a 17 preview of what the effect of incorporating 18 HDDM may look like going forward. 19 CHAIR SAMET: Okay, thank you. 20 Any questions? 21 DR. VEDAL: I only see what you're 22 describing on that bottom left plot, really, Page 368

1 where there's that more marked distribution 2 shift. There is some in the, you know, zero

3 whatever values -- 4 DR. DOWNEY: Okay, let's look at 5 where I rolled these back to. This is for 6 Riverside, meeting a standard of 95 parts per 7 billion. 8 DR. VEDAL: Right, and I see those 9 are design values. 10 DR. DOWNEY: Design values.

11 DR. VEDAL: Yes. 12 DR. DOWNEY: This is for Riverside 13 meeting 80. And so as you get further and 14 further down, if you're in a place where you 15 have this strong NOx scavenging, you'll see 16 this in more rural areas, you don't have this 17 piling up at zero. So the issue is, when 18 you're in a place with a lot of NOx you get in 19 the observations a piling up of zero and the 20 rollback maintains that. But that's an 21 artifact of the non-linear chemistry of ozone 22 because NOx scavenges ozone. So as you cut Page 369 1 emissions that goes away and that's what this 2 is bringing to light is that there's this 3 shift on both sides. And so certainly this 4 will be more of an urban phenomenon, I think, 5 than a rural phenomenon, if that makes sense.

6 Yes? 7 DR. CHOCK: Do you do this based 8 on the NOx reduction alone? 9 DR. DOWNEY: This was NOx and VOCs 10 together. 11 DR. CHOCK: Together.

12 DR. DOWNEY: Yes. 13 DR. CHOCK: And domain-wide rather

14 than -- 15 DR. DOWNEY: Domain-wide, and the 16 domain was the entire U.S. 17 CHAIR SAMET: Okay, thank you. So 18 what I'm going to suggest is that we maybe go 19 back a little bit to this further discussion 20 of, at this point I'm confused about what to 21 call it, but the set of issues sort of 22 associated with policy related background,202-234-4433 Neal R. Gross & Co., Inc. Page 370 1 various ways to model. 2 And I think what I'd like here is 3 a little help perhaps, Ted, before you go out 4 the door, and then anybody else to sort of lay 5 out at this point what you think the issues 6 are that would benefit from further 7 discussion. We certainly discuss a lot of 8 these issues, and I think the real question is 9 have we come to grips with them enough in a 10 way that we can write a cogent and coherent 11 set of comments about them? So let me push 12 that difficult charge on you. 13 DR. RUSSELL: Oh sure. And Daniel 14 and I can maybe argue about this, or iterate 15 on this. 16 So one of the first questions has 17 to be is if we're going to an HDDM approach 18 there's less need to actually look into the 19 PRB. Although I still think whether they go 20 the HDDM route or not that's an important 21 concept to bring through in the ISA, and I 22 wouldn't be against them actually using some Page 371

1 estimates of the PRB in some of their 2 analyses. And they might even use a couple of 3 different ways of getting there. Because 4 there's essentially the purely modeled base 5 way, which is how they've done it 6 historically, and then there is essentially 7 getting there by starting with the observation 8 and, you know, you've got the fused ozone 9 fields and then you subtract the amount of 10 ozone formed from the U.S. emissions via the 11 HDDM way. However, as I pointed out that 12 actually will still overestimate the 13 background concentrations because it doesn't 14 pick up the impact of the U.S. on itself after 15 it goes around the globe, you know, one, two, 16 three, four times. And I'm not sure how big 17 that is. 18 I mean Daniel, do you have a feel

19 for that? 20 DR. JACOB: It's pretty small, a 21 couple ppb. 22 DR. RUSSELL: A couple ppb. So it Page 372 1 would just have to be recognized that that's 2 going to be a bias in that. There is 3 potential for HDDM to either overestimate or 4 underestimate the variability in the 5 background impact. And I can't convince 6 myself it's going to be one way or another at 7 this point, so that would just be another 8 uncertainty that would have to be addressed. 9 And I think really the exercise, 10 and I'd like to see them do this, to develop 11 their policy-relevant background, you know, 12 the way they've done it so far as well as 13 essentially doing it by the HDDM way, 14 subtracting from the observations is I think 15 it gives you a good idea. It'll help bound it 16 and it'll provide the uncertainties, and I 17 think that would be a useful thing to see. 18 And then potentially use those uncertainties 19 in some of their analyses, or at least address 20 them. Discuss what, you know, the levels of

21 them. 22 But if they're not going to use, Page 373 1 they're never going to use the policy-relevant 2 background directly, I'm not sure how much 3 further they have to go than they are right

4 now. 5 CHAIR SAMET: Okay. Daniel, do 6 you want to comment for that? 7 DR. JACOB: Yes. And I agree with 8 what Ted is saying. I mean even if you use 9 this so-called observation based approach 10 starting with your data and then applying 11 HDDM, you're still very sensitive to what CMAC 12 thinks should be the background, because this 13 is what's going to define your slopes 14 extrapolated to zero emissions, right. 15 DR. RUSSELL: To a lesser degree. 16 DR. JACOB: Maybe to a lesser 17 degree. But I think it's important. Let's 18 assume that we need to have some good 19 knowledge of the background. Fred has been 20 very insistent in that and then for some good 21 reasons. Then I think we need to figure out 22 what kind of background values scene that202-234-4433 Neal R. Gross & Co., Inc. Page 374 1 produces, and compares that to the CMACs and

2 GSM values. 3 DR. RUSSELL: Oh, I think that 4 goes without saying. 5 DR. JACOB: Okay, fine. Yes. 6 DR. RUSSELL: And in fact, they 7 should calculate, you know, if they can and I 8 don't see why not. You know, they've already 9 done the calculation very near zero emissions 10 in terms of the sensitivities, just to see if 11 they're very different at a zero. Because if 12 they're not that different at the zero versus 13 ten percent, I don't think you'll see a huge, 14 you know, then what's that saying is that the 15 impact of what, quote, "the background 16 conditions are," is small on the sensitivity 17 coefficients. 18 DR. JACOB: Yes, the other point I 19 wanted to make is that from this approach what 20 you would get is a U.S. background.

21 DR. RUSSELL: Yes. 22 DR. JACOB: All right, so you Page 375 1 wouldn't get the North American background and 2 you certainly would not get the natural 3 background. Yes. I don't think that CMAC 4 could get the natural background even with its 5 hemospheric version since the southern 6 hemisphere is not pristine. So I don't think 7 it -- 8 CHAIR SAMET: Okay. Other

9 comments?

10 Fred? 11 DR. MILLER: I have a question for 12 Ted. You mentioned about doing one thing, 13 like I think it means this down to zero, and 14 then the other way they're treating PRB right 15 now. Well, they're not treating PRB right now 16 so I'm not sure what you were, which kind of 17 scenario you were referring to. And I guess 18 I'd also prefer to change my statements in 19 terms of PRB to just talk about U.S. 20 background. 21 You know, I mean it's not a matter 22 of the policy per se, but just what are the Page 3761 background levels in this country from non2 anthropogenic sources? And maybe some of the 3 sensitivity here, and we can get into the 4 politics of the science policy that we're 5 going to be addressing tomorrow separately. 6 So I wasn't clear, Ted, what other 7 scenario you were referring to when you made

8 that comment. 9 DR. RUSSELL: So the comment in 10 terms of how to calculate this new PRB 11 approach, is what they're doing is they're 12 starting with an observed surface. So they're 13 taking the observations and then they're going 14 to decrease the ozone from there using the 15 sensitivity of ozone to U.S. emissions. 16 And if it was really -- but I 17 won't make Bryan cringe -- if they wanted to 18 they could also look at Canadian and Mexican 19 actually at the same time, but it's just more 20 work. It's more computer time, and I'm not 21 sure that it would add that much information 22 to what they want to do. Page 377

1 Yes? 2 DR. HUBBELL: I was just going to 3 point out that's not off the table. In fact, 4 that's one of the issues we're dealing with 5 when we think about looking at alternative 6 standards is whether we would need to tap into 7 Canadian and Mexican emissions as well as U.S. 8 emissions in order to be able to do the 9 sensitivities. I don't know because we 10 haven't done that yet, but I certainly was not 11 implying that we have made a final decision 12 that we would not look at sensitivity to North 13 American emissions as well as U.S. We haven't 14 really discussed that fully. 15 DR. RUSSELL: Okay, so given that 16 Bryan just agreed, you know, that could be 17 done at the same time and you could answer 18 that question as well and get the separate 19 impact of North American, non-U.S. emissions 20 at the same time and include that in your 21 analyses. 22 Did that answer your question,202-234-4433 Neal R. Gross & Co., Inc. Page 378

1 Fred? 2 DR. MILLER: Yes, thank you. 3 CHAIR SAMET: I think, Fred, you 4 made a proposal that I just want to make sure 5 I heard it right, which is that the term "PRB" 6 be stricken.

7 DR. MILLER: Yes. I want to be 8 able to get into the analysis background and 9 then convince you tomorrow about why you need 10 the fraction of risk that's attributable to 11 expose above whatever that background level 12 is. And I'm not calling that policy, but 13 that's kind of the analysis it would be in the

14 PA document. 15 DR. RUSSELL: And I will agree 16 with Daniel that you cannot get natural 17 background at this time in that approach. 18 DR. HUBBELL: I'm sorry. Are you 19 saying using the HDDM approach you can't get 20 natural background, correct?

21 DR. RUSSELL: Yes. 22 DR. HUBBELL: Okay. Page 379

1 DR. RUSSELL: Because your 2 boundary conditions, I mean -- 3 DR. HUBBELL: Right. But you 4 weren't saying that there's no way to get 5 natural background -- 6 DR. RUSSELL: Oh, no, no, no. 7 Just that approach with the current modeling 8 setup, I mean you would have to go to a global

9 model. 10 CHAIR SAMET: Right. So -- 11 DR. BRAIN: I have an adjacent 12 question. Yesterday, Daniel, I think, gave a 13 very clear exposition of the PRB, the U.S. 14 domestic one, the North American one, and 15 said, yes, you know, each one has an identity, 16 a definition. So I'm still a little confused 17 as to whether this committee and the staff has 18 a preference for one of them. Are they going 19 to use all three of them or just two of them? 20 Where and when will they express, you know, 21 when one is appropriate and when the other is 22 appropriate? It seems to be it will be Page 380 1 confusing if there are too many different 2 approaches to background. 3 DR. RUSSELL: I mean that's truly 4 a policy question.

5 DR. BRAIN: So all three have to

6 be -- 7 DR. RUSSELL: I think all three

8 have value.

9 DR. BRAIN: But then shouldn't 10 someone express the relative value of these 11 different --

12 DR. RUSSELL: Yes. 13 DR. BRAIN: -- approaches?

14 DR. RUSSELL: I mean and that 15 would, to me, naturally go in, you could use 16 it in the REA and PA and just say this is why 17 you're using the natural background, U.S. 18 background, North American background. 19 DR. BRAIN: So I guess I'm just 20 asking that there be clear guidance for that. 21 CHAIR SAMET: Okay, other comments 22 on this vexing issue? Is it a little clearer? Page 381

1 DR. DIEZ-ROUX: I mean to me the 2 key issue is how the background is going to be 3 used. And I don't know if we want to talk 4 about that now or tomorrow but that's the key 5 issue. 6 CHAIR SAMET: It's certainly a 7 tomorrow issue. 8 DR. HUBBELL: Well, one thing, I'd 9 like to get clarity on that because I'm 10 assuming that that will then feed back to us, 11 because the question of how it's to be used in 12 the policy assessment will ultimately guide us 13 as to what we need to focus on, on terms of 14 producing estimates. And it's very difficult 15 for us to envision a world where we're going 16 to have to produce four times as many 17 estimates for how ever many alternative 18 standards. So it needs to be a little bit 19 more guidance on that. 20 I think I mentioned this morning, 21 you know, my preference is to focus on natural 22 background if we're going to do a risk-based202-234-4433 Neal R. Gross & Co., Inc. Page 382 1 run, and then provide information from either 2 the sensitivity runs, et cetera, that gives us 3 information about how you would apportion the 4 air quality changes to the HDDM, based on 5 HDDM. So I think it would be helpful to get 6 a little more guidance than simply, you know, 7 the policy assessment needs to address it in 8 a particular way, because we have to generate 9 the estimates. 10 DR. MILLER: And Daniel, could you 11 redefine for us about natural background 12 versus U.S. background? 13 DR. JACOB: Well, Bryan could -- 14 okay, but natural background is no15 anthropogenic emissions anywhere, and pre16 industrial levels of methane. On the planet, 17 yes. 18 DR. MILLER: Okay. 19 DR. JACOB: U.S. background is no 20 anthropogenic emissions in the United States. 21 Including Canada and Mexico. Now you can get 22 it with either ship emissions, aircraftPage 383

1 emissions, those are -- 2 (Off microphone comments)

3 DR. MILLER: But does that mean

4 that one of the three of these has more 5 implications for the flexibility you have and 6 what you might attain by choosing an 7 alternative level of the standard? It looks 8 like -- 9 DR. JACOB: Well, I mean it does, 10 but this is as Ted pointed out, the policy 11 question. I'm eager to what Lydia and Bryan 12 have to say about this. Clearly, if you're 13 just using the natural background and on that 14 basis you figure out the risk associated and 15 the costs associated with elevated ozone, and 16 then you say, well, what do I do about it? 17 Well, you have to talk to China about lowering 18 its emissions. And is this something that's, 19 I mean the point, won't that put you in a 20 pickle? Because then you'll have the standard 21 that cannot really net or is not designed to 22 be solely net proof U.S. emission controls. Page 384 1 But I'm getting out of my depth here. 2 MS. WEGMAN: So yes, I think we're 3 getting a little bit ahead of where we are 4 right now. Chris, this morning, was talking 5 about the fact, and he's correct, this is a 6 decision for the Administrator to make when 7 she comes to consider, he or she, comes to 8 consider the question of what should the 9 standard level be and how to think about 10 background. So that's not a question we're 11 going to be prepared to answer tomorrow 12 because there are both legal and policy 13 considerations that go into the question of 14 how background is or is not considered in 15 selecting a level of the standard. There are 16 multiple factors that will obviously go into 17 the selection of the level of the standard. 18 So I think what we're looking for 19 today is your best advice from the standpoint 20 of the risk assessment as to how we should 21 think about background. What are the right 22 analyses to do for purpose of the risk Page 385

1 assessment that will then feed into the policy 2 assessment? That's really what we're looking 3 for today. And tomorrow we will talk more 4 about the policy assessment, and I'm sorry Ted 5 and Daniel won't be here for that. But we're 6 looking for your guidance today and that -- 7 DR. MILLER: Then doesn't that say 8 that it varies down to zero, and the worst 9 case scenario would be the North America 10 background? Those two define the extrema. 11 DR. HUBBELL: Why North American 12 background rather than natural? 13 DR. MILLER: Because it includes 14 more things that you can't control that are 15 there, that are out there, if I'm 16 understanding it correctly. 17 DR. HUBBELL: But again, I think, 18 one thing I want to be careful about is again, 19 determining what is controllable or not 20 controllable. Again, one of the purposes of 21 trying to broaden our understanding of this 22 was to be able to allow, and again this was a202-234-4433 Neal R. Gross & Co., Inc. Page 386 1 comment that was also made by CASAC last time, 2 which is understanding what risk is coming 3 from manmade or anthropogenic, the source to 4 ozone. Regardless of whether it's from the 5 U.S. or from North America or from 6 international sources, it's good to know and 7 to be able to think about options for 8 addressing international transport. If you 9 haven't identified the risk it's not possible

10 to do that. 11 Our approach of rolling back the 12 air quality values based on first starting 13 with the U.S. emissions and then considering 14 whether you would need to go to North American 15 and then to outside of North American 16 emissions in looking at alternative, 17 simulating just meeting alternative standards 18 allows you to be able to give that information 19 through the Administrator about, will you be 20 able to attain this alternative standard with 21 U.S. emissions? If not, will you be able to 22 attain it with North American emissions, and Page 387 1 so forth. It allows you to have both sets of 2 information. 3 MS. WEGMAN: But I just want to 4 remind everybody that the feasibility of 5 attaining the standards is not relevant to 6 selecting the standard level. 7 CHAIR SAMET: Let me try and 8 phrase it because I may or not have it, so if 9 I don't, tell me. So if you use zero you 10 obviously have all ozone risk. That's the 11 easy case. If you use U.S. background rolled 12 back to current standard, the difference is 13 that risk attributable to theoretically 14 controllable ozone based on U.S. emissions. 15 And then you can say of 100 percent so much 16 can be addressed by rolling back to different 17 points. 18 The other way to look at this, 19 which I've think you've heard, is to start 20 with the current standard, roll to all the 21 counties to that point, and then have other 22 scenarios where you have more stringent Page 388

1 standards and look at how much risk is 2 reduced. Is that the other way you are going 3 at this or do I have this wrong?

4 DR. HUBBELL: What we are 5 suggesting is that you would start with the

6 current levels of ozone. You would then 7 attain the current standards. 8 CHAIR SAMET: Right. 9 DR. HUBBELL: And then you would 10 continue to use U.S. emissions based on the 11 HDDM runs to just attain an alternative 12 standard and continue going down. Now at some 13 point we may, again we don't know because we 14 haven't done this, we may run out of U.S. 15 emissions and still not have attained. In 16 which case, if we've done the HDDM run with 17 the tags for North American emissions, we can 18 then say, well, what if we also reduced North 19 American emissions, which would be Canadian 20 and Mexican emissions? And then if you didn't 21 attain at that point you could even go further 22 and say, what if you were to reduce Page 389

1 international emissions? 2 I'm not saying that that's how far 3 we'd have to go, it's just that by having the 4 tags in there you could go down that way. And 5 eventually, obviously, if there was still no 6 attainment then you'd have a problem because 7 you would then be down to naturally occurring 8 ozone. I'm not anticipating that's going to 9 be the case, but again that's the layered 10 approach we would take to be able to look at 11 alternative standards. And again, in each of 12 those cases you don't have to specify 13 background specifically. It's done by taking 14 off the emissions.

15 DR. MILLER: You don't have to 16 specify it, but if I understand, by pushing 17 the right button on the HDMA you can get the 18 fraction of the risk reduction that's due to 19 above whatever you ended up with your estimate 20 of background. 21 DR. HUBBELL: With the exception 22 of natural background, yes.202-234-4433 Neal R. Gross & Co., Inc. Page 390 1 DR. MILLER: With the exception of

2 natural. 3 DR. HUBBELL: But we could again, 4 we could introduce a background, a natural 5 background would do that. 6 DR. MILLER: So that sounds like a 7 reasonable plan. I'm just arguing that I 8 think the Administrator is going to need that 9 information for making the defining decision 10 on whatever to select. And so I think you're 11 going to be charged with getting it and you 12 might as well do it while you're a part of 13 this process. But it seems to me like your 14 hierarchal step-down is a logical way to go. 15 The only thing I would add in is you've thrown 16 into here questions about -- well, that's 17 actually for tomorrow. Never mind about below 18 60, forget it. 19 CHAIR SAMET: Okay. Other 20 comments on this issue?

21 Ana? 22 DR. DIEZ-ROUX: I think, to me, Page 391 1 it's helpful to distinguish two separate 2 things. One is estimating the deaths 3 attributable to ozone, period, right now, 4 right. And for that exercise, to me, it makes 5 sense to go all the way down to zero because 6 there's evidence that there's a linear 7 relationship. I mean you could argue whether 8 going below the lowest measure, whatever it 9 calls, the lowest measure introduces more 10 uncertainty, whatever, but in principle, if 11 you want to estimate the total deaths or 12 whatever health outcome are attributable to 13 ozone based on the evidence we have so far, it 14 makes total sense to go down to zero. 15 Now a separate question is how 16 many deaths would be saved if we established 17 a given standard? And when you do that you 18 could take say best case scenario, maximum 19 achievable impact would be if you could 20 achieve a standard and see how that changes. 21 But we know that in reality that might not be 22 achievable because that might imply going Page 392 1 below the background for some locations. And 2 so then you could show estimates accounting 3 for that but you will be able to go below, you 4 know, this background or that background, and 5 you can show different sensitivity analysis. 6 So you have the potential maximum 7 benefit versus the anticipated realized 8 benefit assuming different backgrounds that 9 you will not be able to go below. And that 10 information, I think, is very useful to the 11 Administrator. But I think the first piece, 12 estimating the overall health impact of ozone 13 should not take into consideration the 14 background, because I think, from my 15 perspective, that just muddles the issue. You 16 still have the information that you need in 17 the other section to allow you, what can you 18 actually do. So to me that would be the most, 19 and I think that's the way you've been doing 20 it. 21 CHAIR SAMET: Okay. Well, I think 22 we will have an interesting discussion Page 393

1 tomorrow. Let's see, I think we'll be absent 2 Ted. We'll have Daniel on by phone. 3 DR. JACOB: Early, yes. 4 CHAIR SAMET: Early. All right,

5 and who else? 6 Okay, and some wish they were on 7 by phone, but you'll be here. So tomorrow 8 we'll be starting at 8:30, and onto the policy 9 assessment. So thanks for all your hard work 10 over this couple days, and more tomorrow. 11 DR. NUGENT: Thank you all very 12 much for all your comments on the REAs. 13 (Whereupon, the above-entitled 14 matter went off the record at 4:39 p.m.)

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